lapkyuky LokLF lsoksa eiznsrsquok

ftyks esa HkaMkj ds j[k j[kko oa izcaku gsrq fnrsquokk funsZrsquok

1- lapkyuky kjk LVksj lakkjk dh ekxZnkfrsquokZdk okZ 1977 esa tkjh dh xbZ Fkh

tks Annexure ndashI esa layXu gSA bldk ikyu fdk tksa A

2- nok LVksj ds izHkkjh dEikmMjQkekZflLV] LVkWd jftLVj] brsquokw jftLVj rFkk

[kpkZ jftLVj dk lakkjk djsaxsA izfrfnu brsquokw dh xbZ nokbZksa dk [kpkZ

LVkWd jftLVj esa vafdr djssaxsa lkFk gh gLrkkj djsaxs] okMZ vFkok vksihMh esa

jksxh dks nh tkus okyh nokvksa dk [kpkZ jftLVj esa vafdr djsa oa gLrkkj

djsaxsA

3- [kpkZ jftLVj esa k rks ejht dk uke vFkok vksihMh ua- vFkok okmpj uEcj

nsus ds ckn mldk uEcj [kpkZ jftLVj esa vafdr djsa ftlls izekfkr gks

lds fd fdl jksxh dks nok nh xbZ gSA fn bl izdkj ls ugh fdk xk rks

bls vfuferrk ekuk tk dj lacafkr ds fo dkZokgh dh tksxhA

4- brsquokw fLyi esa okmpj uEcj Mkydj [kpkZ vafdr djus dk rjhdk bl izdkj

gksxk fd Oslashe ls lcls igys vkus okys jksxh dks fpfdRld kjk fy[kh xbZ

brsquokw fLyi esa Oslashersquok 1 2 3 vkfn vafdr fdk tk vkSj uEcj ds pkjks rjQ

xksyk cukk tk Serial Order eas [kpkZ jftLVj esa okmpj uEcj 12 vFkok

3 ds lek brsquokw fLyi esa fy[kh xbZ nok dh ek=k fy[kh tkA izRsd i`B ds

var esa d izdkj dh nokbZZ dk tksM+ fy[kk tk rFkk QkekZflLV dk gLrkkj

oa uke ntZ gksA

5- izfrfnu vksihMhokMZ vkfn esa brsquokw jftLVj eas izkjfEHkd ksk nok ds lkeus

fy[kk tk rFkk [kpkZ jftLVj esa fy[kh xbZ nokvksa dh ek=k dk tksM+ dj

dqy [kpkZ fy[kk tkA fnu ds var esa [kpkZ jftLVj esa izkjfEHkd ksk ls

[kpkZ kVk dj vafre ksk fy[kk tkA

1

6- vxys fnu bl vafre ksk dks izkjfEHkd ksk ds rkSj ij iqu fy[kk tkA

nokvksa dk iznk ekax i= ds vkkkj ij fdk tkas o iznk rhu brsquokw okmpj

tkjh dj fdk tksA brsquokw okmpj dh d izfr esa lacafkr laLFkk ds LVkWd

cqd ist ua- dh izfofV izkIr gksus ij gh nwljh ckj iznk fdk tkA fn

brsquokw okmpj esa LVkWd cqd izfofV vxys ekax i= esa ugh izkIr gks rks lacafkr

ds fo dkZokgh dh tksaA

7- nokvksa dk lRkiuamp

nokvksa dk lRkiu LVksj izHkkjhvksihMhokMZ izHkkjh izfrfnu de ls

de nks nokvksa dks fQftdyh LVkWd psd djsaxs A evks izHkkjh] LVksj izHkkjh]

vksihMh vFkok okMZ izHkkjh lIrkg esa d fnu de ls de nks nokvksa dk

HkkSfrd lRkiu djsaxsA

laLFkk izHkkjh] lh-l-] lh-e-p-vks- izRssd LVksj dk ekg es dfnu

nks nokvksa dk lRkiu lqfufrsquopr djsaxsA

bl ckr dk forsquoksk ku j[ksa fd LVksj dk lakkjk fuekuqlkj gks

jgk fd ugha g flfoy ltZu vkSj eq[ fpfdRlk oa LokLF vfkdkjh dh

OfDrxr ftEesnkjh gksxhA

blds vfrfjDr ftl deZpkjh vFkok LVksj dhij ds ikl fQftdyh

pktZ gS] og LVkWd lakkjk gsrq iwkZisk tckonkj gksxkA

evks bapktZLVksjfMLisaljhokMZ LVkWd jftLVj ds izRsd izfofV

ij gLrkkj oa fnukad vafdr djsaA [kpZs dk lRkiu lIrkg esa d ckj

vorsquo fdk tksaA

8- eq[ fpfdRlk oa LokLF vfkdkjh vkSj flfoy ltZu izRsd LVksj dk

HkkSfrd lRkiu okZ esa d ckj nwljh laLFkk ds fpfdRlk vfkdkjh ls djkosaA

blh izdkj esa izRsd LVksj dk vkarfjd =Sekfld fQftdyh osfjfQdsrsquoku LVksj

izHkkjh dks djuk gksxkA

9- izRsd laLFkk esa nokvksa dh Dlikjh jftLVj dk lakkjk fdk tk ftls

evksizHkkjh izRsd lkr fnu esa oa laLFkk izeq[k izRsd d ekg esa d

ckj ijhkk djsxkA nokW izkIr djrs oDr bl ckr dk forsquoksk ku j[kk 2

tk fd dkykrhr vofk de ls de 112 okZ gks vkSj nokvksa dk iznk

FEFO in~fr ls fdk tkA bldk rkRiZ g gS First Expiry First Out

vFkkZr ftl nok Dlikjh igys gS mls igys brsquokw fdk tkA fn dksbZ

nok dkykrhr gksrh gS rks mls i`Fkd LFkku ij j[ksa o jkbZV vkWQ dh izfdzk

djsaA

10- nokvksa dk HkaMkjk OofLFkr fdk tkA nokvksa dks tehu esa ugh j[kk tk

mUgsa OofLFkr rjhds ls vkbZju jSd eas j[kk tk d izdkj dh nokbZ d

jSd eas j[kh tk rFkk jSd eas fcu dkMZ yxks tkA fcu dkMZ ls rkRiZ gS]

iksLV dkMZ dh lkbZt dk dkMZ ftlesa nokvksa dk uke mij fy[kk tk

Dlikjh fy[kh tkA rFkk dze ls frfFkokj nok brsquokw dh ek=k rFkk cpr

vafdr fdk tksaA

11- LVksj esa izfrfnu lkQ lQkbZ dh tksaA vuqiksxh lkeku tSls VwVk QwVk

QuhZpj midjk [kkyh dkVZwu ugh j[ksa tksA

12- dEIqVj rFkk vkWisjVj dh OoLFkk dj buosaVjh esustesaV fdk tksaA izRsd

15 fnu esa LVkWd cSysal fjiksZV cukbZ tksA

13- fcy lkr fnu eas lRkfir dj dkamV lsDrsquoku dks Hkstk tk rFkk nl fnu

esa Hkqxrku lqfufrsquopr djsa A

14- brsquokw fLyi dks d cqd ds i eas Niokk tk frac14izki layXufrac12 Annexure

AampB ftldh izFke izfr ejht dks nh tk ftls LVksj izHkkjh ladfyr

djsxk] frh izfr fpfdRld ds ikl jgsxhA bu fLyi ds vkkkj ij

lRkiu fdk tksa A

frac14MkW- -u-feRryfrac12 lapkyd LokLF lsoksa

eiznsrsquok

3

Directorate of Health Services

Satpura Bhawan

Madhya Pradesh

P R O C U R E M E N T ndash Government Order Relating to the Management of Stores

(Reproduced for reference material on basic procedure in decentralize d s y s t e m

followed by Health facilities in 1977)

Note This is for reference only as with New Drug Policy 2009 and systems going

changes all conditions may not hold good

MODULE I

4

FLOWCHARTS

middot EASY UNDERSTANDING OF THE PROCESS INITIATION O F T H E

PROCESS OF EMPOWERED PROCUREMENT WING-ldquoDRUG

C E L L-DIRECTORATE HEALTH SERVICESMADHYA PRADESHrdquo

middot UNDERSTANDING THE REQUIREMENT amp CHOOSING THE

CORRECT METHOD OF PROCUREMENT WITH APPROVAL OF

THE PURCHASE AND TECHNICAL COMMITTEE AS PER THE

DRUG POLICY

middot T HE TENDERING PROCESS

middot BRIEF OF THE PROCEDURE TO BE ADOPTED AFTER THE BIDS

ARE FINALISED

Flow Charts

P r o p o s e d S y s t e m I n i t i a t i o n

5

6

bull S y s t e m

7

bull System of Tendering at a Glance

8

DIRECTORATE OF HEALTH SERVICES MADH YA PRADESH

No Q E q p O c t 7 7 Bhopal the 2 6 th October 1977

(E x t r a c t e d f r o m t h e G O and reproduced f o r 2 0 1 0 -11 to have clearity on process of

procurement )

To

The Deans

The Divisional Joint Directors of Health

Th e J o int Director of Ayurveda

The Administrative officer ESISIndore

The Superintendents of Medical College Hospitals

The Superintendents of Special Hospitals

The Civil Surgeons

The District Family Welfare cum Health Officers

The Principals RHFWTC

MADHYA PRADESH

Subject -Rules Orders for management of stores

The Government of Madhya Pradesh in the department of Public Health and family Welfare have by their order No 305847795-2877MedIII dated the 13 th

October 1977 issued Rules for the management of STORES These come int o force from the day they are received by the officer-i n- charge of an institution

It is desired that these Rules be followed strictly both in lsquoletter and spiritrsquo and no explanations would be accepted for non-compliance

Sufficient number of printed cop ie s a r e be ing se n t to you f o r d istr ibution a m ongst your subordinate staff concerned with the subject

A C Gaur For Director Medical Services

Madhya Pradesh

9

ACQUISITION OF STORES

The word Stores used hereunder applies generally to all articles expendable as well as dead stock of the nature of plant machinery instruments furniture fixtures medicines linen etc etc

Any authority which is competent to incur contingent expenditure may sanction the purchase of stores required (sub ject to his d e le ga tion of f ina nc ia l pow e r s) pr o vide d the following rules are observed-

(a) A Purchase Committee comprising of atleast three Gazetted Officers is formed for approving quantity and quality of stores required

( b ) An enquiry for the articles purch ased should be sent out to various manufacturers and dealers if the total of the order is for Rs 15000 or less In case the purchase order is likely to exceed Rs 15000 ldquoopen tendersrdquo be called through news paper publicity ( f igur e s p e r ta in to 1 977)

(c) Stores s h o u l d n o t b e p u r c h a s e d i n s m a l l q u a n t i t i e s and often if such store is not perishable

( d ) Requirement of the whole year to be worked out a nd n o stor e sh ould b e p ur c h a se d in e x c e ss o f the requirement

(e) P u r c h a s e s h o u l d b e m a d e i n t h e m o s t e c o n o m i c a l manner but q ua lity ne e d not be sa c r if ic e d in the interest of the economy

(f) The details regarding the quality desired and expected purchase quantity should be mentioned in t h e e n q u i r y

(g) Purchase order should not be split up to avoid the ne c e ssity o f obta ining th e sa nc tio n o f t h e h i g h e r authority

( h ) The date and time of opening of the tender should also be published and in case the tenderers desire to be p r e se nt o n th e o c c a sio n th e y should b e a llo w e d t o d o s o

( i ) Mere initialing on the covers of the tenders is not sufficient All the Purchase committee members s h o u l d s i g n o n e a c h a n d e v e r y p a g e o f t e n d e r q u o t i n g t h e r a t e s A n y r a t e s w h i c h h a v e b e e n overwritten by the tenderer should not be c o n s i d e r e d u n l e s s t h e y b e a r t h e t e n d e r e r rsquo s s i g n a t u r e and subsequently signed by a member o f t h e Purchase committee

( j ) A list of tenders opened should be made out and t a l l i e d w i t h t h e o n e o f t h o s e r e c e i v e d i n t h e o f f i c e Such a list should be signed by all the members of the Purchase committee

( k ) A comparative statement is then made and lowest t e n d er i s a c c e p t e d s u b j e c t t o q u a l i t y o f f e r e d b e i n g

10

satisfactory Samples of non perishable articles should be preserved safely under lock and key for comparison till the contract for supply is in force

( l ) R e a s o n s for rejecting the lowest tender and accepting the h i g h e r o n e s h o u l d a l w a y s b e r e c o r d e d in writing by the Purchase Committee

(m) No reason for rejecting the lowest tender need to be communicated to the tenderer

( n ) Every purchase order should clearly mention that the articles ordered shall be accepted subject to t h e approval of the Purchase Committee

( o ) Rules regarding deposition of earnest money and security money should be observed

( p ) For emergent purchases in public interest when there is no time to observe Store Purchase Rules purchases should be made up to Rs 2 5000 (refers to year -1 9 7 7 ) a t a t i m e A s f a r a s p o s s i b l e t h i s practice should be avoided

II PLACING OF ORDERS (a) For medicines and such other articles which the Medical Stores Depot Bombay

supplies order be placed with them at a specified time ( b ) For articles not on the Bombay Stores Depot Bombay lsquolimitedrsquo or lsquoopenrsquo

tenders be invited as the case may require It would be preferable to place orders on the manufactures or their authorized distributors

(c) For placing the orders on PSUrsquos Laghu Udyog Nigam or Organisations approved by the State government no tender needs to be invited

( d ) Price preference upto 10 is available to Small Scale Industries of this State only(not applicable as per New drug policy 2010 -1 1 )

III RECEIPT OF STORES All materials received should be examined counted measured or weighed as the

case may be when the delivery is taken The stores thus verified be may be immediately entered in the stock register Book under proper headings and this fact should be recorded on the body of the bill mentioning the page number of the Stock Book It should also be mentioned whether the quality and the quantity are correct as per the requirement Soon after the receipt each item be stamped with the initials of the institution

IV CUSTODY

(a)The head of the institution should ensure suitable accommodation for keeping the stores with a view to prevent losses through theft accident fraud or otherwise

(b) Separate Stock Accounts should be kept of-( i ) D e a d S t o c k-such as plantmachineryfurniture equipmentinstruments

etc (ii) Expendible items such as medicineslinenrubber goods etc (iii) Perishable articles

(c ) all recepts and issues in the stores stock registers should be on the authorityand under the signature of a respon sible officer deputed for the purpose

11

V ISSUE OF STORES (a) When materials are issued from stock the officer -i n ndashcharge should ensure that the indent is in proper proforma (Annexure A) and the person taking delivery is an authorized one (b) The issue vouchers (Annexure B) for articles should be prepared in triplicate by one single stroke of pen The first copy will remain with the records of the stores The second and third copies will go to supplies The second copy will be retained by the person receiving the supplies and the third copy will be returned by the receiver to the stores after making entries of hisher stock book page number etc against each item ( C ) E v e r y t i m e i s s u e b e r e c o r d e d i n t h e s t o c k b o o k o f t h e s t o r e s w i t h s i g n a t u r e s o f t h e O f f i ce r i n -charge

(d) Every issue made from the Central Stores to other institution should show cost of article preparation of Annual Stores Account at a later date

VI Maintenance of Stock Books (a) Stock book should be kept under the charge of a responsible person and should be

saved from loss and destruction ( b ) While making new entries in the main Stores Stock book cost of each item

should be entered though this need not be done in the case of registers in Wards Operation Theatre Out door etc

(c) There should b e n o o v e r-writing or interpolation or smudging of figures Any f i g u r e i f i t i s t o b e c o r r e c t e d s h o u l d b e c l e a n l y c u t a c r o s s a n d t h e n e w f i g u r e should be written by its side or below it under proper attestation

( d ) Stock books should always have a page count(each page be numbered) A certificate showing the number of pages be given on the first and the last page under the signatures of a Gazetted Officer

(e) Receipts issues and balances should be worked out for every item and attested regularly by the Offic er-i n -Charge of the Stores

(f) In the receipt column details regarding the size quality and any special features if t h e r e b e s h o u l d b e r e c o r d e d e g i n t h e c a s e o f A l m i r a h i t s s i z e a n d w h e t h e r i t i s of Steel or Wood

(g) In the Stock-book of library Edition and the ye a r o f p ublic a tion of th e book should always be mentioned

( h ) In case of medicines having an expiry date a list of such medicines be made out and should be checked every week Two months prior to the date of expiry if the s t o c k i s s t i l l f o u n d s u f f i c iently high intimation should be given to Directorate of Health

(i) N o r e m o v a l o f d e a d s t o c k s h o u l d b e m a d e f r o m t h e s t o c k ndash B o o k u n l e s s s o a u t h o r i z e d b y t h e c o m p e t e n t A u t h o r i t y

(j) While making a new Stock book and transferring the stocks therein it should ensured that the page number of the old stock book is shown in the new stock b o o k a n d s i m i l a r l y p a g e n u m b e r o f t h e n e w s t o c k b o o k i s m e n t i o n e d i n t h e o l d one This has to be done to facilitate cross checking whenever desired

( k ) T h e r e h a v e t o b e d i f f e r e n t s e t s o f proforma for dead stocks and for expendable items

Annexure ldquoCrdquo is for former and Annexure ldquoDrdquo for the latter varieties

12

VII PROCEDURE OF INDENTING FOR WARD amp OTHER SECTIONS OF THE INSTITUTION

(a) There has to be an Indent Book with every such section wh ich receives and issues medicinesequipment

( b ) The indent shall be prepared by the nurse Compounded -i n -c ha r g e of th e WardSection in te single copy on the Performa (Annexure A)

(c) The indent so prepared will be signed by the medical officer resident ndash i n c h arge or in his absence by a doctor senior to him but associated with the ward section

( d ) The indent shall then be signed by the head of the institution (Superintendent or the Civil Surgeon as the c a se ma y be ) o r b y his A ssista n t if th e la tte r is so authorized in writing

(e) The indent book is then presented to the main Store for effecting issue (f) The Store will then prepare issue vouchers (Annex B) in triplicate as directed

in Paragraph V (b) supra The supplies and the Indent Book are taken back by the Ward Section- i n - charge after signing the first copy of the issue voucher

(g) Te supplies after arriving in the WardSection shall be entered on the WardSection stock register which is prepared on a proforma (Annexure E) and page number of each entry be shown o n t h e 2 n d a n d 3r d copies of the Issue

voucher The 2 n d copy of the voucher is to be retained in a file in the wardsection but the 3r d c o p y s h o u l d b e r e t u r n e d t o t h e s t o r e b e f o r e s u b m i t t i n g a fresh indent The Store has to be maintain separate files of the 3 r d copies Wardsection-wise

VIIIHOW OFTEN TO INDENT

(a) A wardsection ndash i n -charge should work out an average weekly expenditure of each item and efforts be made to replenish the WardSection stocks every week

( b ) T h e M a i n s t o r e i n o r d e r t o a v o i d h e a v y rush of work should fix a day of issue for each major specialty T w o or th r e e minor spe c ia ltie s c a n be gr o upe d f o r one day

IX EMERGENT INDENT It is very likely for unforeseen reasons either the weekly indent of WardSection stock might get exhausted earlier or something which was not there in the lsquoweekly indentrsquo is required Under such circumstances an ldquoEmergent Indentrdquo could be made out in the usual manner but under the signature of the Unit-i n- chargeconsultant and it must be countersigned by the head of the institution (and not by his assistant) These supplies have also to be entered in the wardSection stock books like others

13

X HOW TO INDENT

(a) The ward Section -i n - c h a r g e s h o u l d e n s u r e t h a t t h e s t o c k s u n d e r t h e i r c h a r g e a r e not unnecessarily large and only a realistic quantity is indented once a week

( b ) The indent should not be made out in the names of the patients or by bed numbers The indent should be for the Wardsection as a whole

XI KEEPING OF RECORDS IN WARDS AND SECTIONS

(a) A set p r o f o r m a ( A n n e x u r e E ) s h o u l d b e u s e d i n t h e w a r d s e c t i o n f o r s h o w i n g u p receipts and issues Balance of expenditure for each item to be drawn out every morning by nursecompounder in charge before writing out the Indent or before restarting work The medica l O f f ic e r r e side nt in c ha r g e sh ould a tte st th e e ntr ie s after satisfying himself- by random checking at least once a week

( b ) To support the above mentioned expenditure the Bed head Tickets (treatment charts) are very important Each medicine prescribed should be legibly written indicating the total quantity prescribed if the medicine is to be deleted from treatment the fact should be mentioned as to how much of the drug was issued to the patient before switching on to another drug The suggestion is that a separate treatment card be maintained for each indoor patient ( Annexure ndash G) A summary s h o w i n g t h e t o t a l a m o u n t o f t h e p r o p r i e t a r y d r u g s c o n s u m e d b y t h e p a t i e n t d u r i n g is hospital stay be worked out and noted in the summary card

XII ACCOUNT ABILITY OF DRUGS BROUGHT BY THE PATIENT OR RECEIVED IN DONATION BY THE WARDSECTION _IN -C H A R G E

The drugs receoived from the non - governmental sources should be entered on the receipts side of the WardSection Sto c k b ook a n d issu e s to show n a s in th e o the r cases on the issues side

XII RSPONSIBILITY OF STORES AT VARIOUS LEVELS (a) The head of the institution shall be held responsible for non-observance of

rulesprocedures laid down by the Government ( b ) The Medical officerresident in charge of the stores and the store keeper shall be

held responsible for any irregularity found in the stores or for ignoring the ordered pattern of working It shall be the duty of the Medical officer Incharge of the Stores to occasionally check the WardSection Stock-b o o k s t o t a l l y t h e e n t r i e s made in the 3 r d copy of the Issue vouchers [as laid down under V (b)supra ]

(c) The Medical officerresident in charge of the WardSection shall be responsible for irregularities in indenting stocksfor maintaining stocks much in excess of the req uirement and for improper keeping of BED HEAD TICKETS (treatment chartsCards)

( d ) The NurseCompounder ndash i n -charge of the WardSection shall be responsible for shortages in stocks for putting up inflated indents and or for not taking into account medicines b rought by the patientson the WardSection stock-books Heshe shall also be held responsible for ensuring proper distribution of medicines to each and every patient under his her charge

XIV DISTRIBUTION OF MEDICINES FROM OUTDOOR DEPARTMENT (A) ( a ) T h e r e are proprietary and non -proprietary medicines (like mixtures ointments

and lotions) which are to be distributed gratis to patients 14

(b) The Outdoor incharge shall arrange to maintain a stock of common drugs (list of which shall be prepared by the Head of t he Institution) and arrange to replenish the stocks once a week as has been laid down for wards (c) No proprietary drugs shall be issued on the prescription of an intern ( d ) The Head of the institution shall make out a list of drugs which can be issued on

the prescription of a houseman from the Outdoor stock without the countersignature of any other authority

(e) The residents can prescribe any drug from Outdoor stock without the counter signature of any authority

(f) The Consultants can prescribe any drug to any ot h e r o u t e r p a t i e n t e v e n i f i t i s n o t s t o c k e d i n t h e o u t d o o r b u t t h i s s h a l l h a v e t o b e c o u n t e r s i g n e d b y t h e h e a d o f t h e institution for issue from The Main Store

(B) T h e p e r s o n i n c h a r g e o f t h e O u t d o o r m e d i c i n e s s t o c k s h a l l k e e p a r e c o r d o f t h e q u a n t i t y o f t he medicines issued to each patient and instead of writing the name and other details e may only put down the Registration number of the patient and the quantity issued

At the end of the day he must work out the total expenditure of eac item and draw it s balance

The Medical officer in charge of the Stores and the Head of the institution sould check these records at least once a week and affix is signature to confirm their inspection

(C ) No proprietary medicine shall be issued without a valid issue s l i p ( A n n e x u r e- F)

(a) For Housemen the slip would be of brown colour ( b ) For residentsDemonstrators it shall be of pink color (c) For consultants the issue slip should be white ( d ) All issue slips should be printed and pages serially numbered (e) T h e d o c t o r s t o w h o m s u c h i s s u e s l i p s w o u l d b e i s s u e d s h a l l b e h e l d

responsible for their sa f e ke e ping a n d th e y w ould e n su r e tha t th e se slip s would be printed and serially numbered

(f) The doctors prescription slips (for issue from hospitals) of proprietary drugs be prepared in du plicate with the help of carbon One copy should be given to patient for obtaining medicines from the Stores and the other would remain in the Doctors Prescription Slip book

(g) Every issue Slip should be signed and below the signatures a rubber s t a m p s h o w i ng name and designation be affixed The Store people would n o t h o n o u r s l i p u n l e s s t h e n a m e o f p r e s c r i b e r i s c l e a r a n d h i s a t t e s t e d signatures are available to stores

( h ) The Store Staff would file prescription slips of each doctor separately to facilitate the scrutiny at least once a month by the Head of the Institution Such a Scrutiny would reveal over prescribing of or injudicious use of drugs

(C) Proprietary medicines should not be issued for more than three days requirement at a time The only exceptions being cases for cancer pulmonary tuberculosis and leprosy In exceptional cases an officer not below the rank of a Consultant can prescribe for more than 3 days but after the countersignatures of the Head of the Institution

15

XV LOSS BREAKAGE DAMAGE ETC

(A) Any loss of public money departmental revenue of receipts stamps stores or other property held by or on behalf of the Government caused by defalcation or otherwise discovered in an office or institution should immediately be reported by the officer concerned to the head of department through his immediate superior as well as to the Accountant General if the loss exceeds Rs 20000(fig of 1977) (for Proforma see Annexure I)even when such loss has been made good by the party responsible for it Such reports must be submitted as soon as possible and soon after suspicion arises that there has been a loss they must not be delayed while detailed enquiries are made

When the matter has been fully investigated further and complete report should be submitted of the nature and extent of loss showing the errors or neglect rules by which such loss showing the errors or neglect of rules by which such loss was rendered possible and prospects of effecting such recovery

The s ubmission of such a repot does n o t d e b a r t h e l o c a l a u t h o r i t i e s t a k i n g f u r t h e r a c t i o n which may be deemed necessary like handing over the case to the police

Every Government servant should realize fully and clearly that he will be held personally responsible for any loss sustained by the government through fraud and negligence on is part and that will also be held personally responsible for any loss arising from fraud or negligence on the part of any other Government servant to extent to which it may be shown that he has contributed to loss by his own action or negligence

A s s o o n a s s h o r t a g e i n s t o c k o r l o s s i s d i s c o v e r e d a p a r t f r o m r e p o r t i n g t h e m a t t e r a responsible officer should be deputed to investigate the matter

W h e r e t h e r e i s n o l i k e l i h o o d o f a d e l i b e r a t e t h e f t b u t l o s s i s a result of neglect onlythe loss should be made good by the person on whose charge or custody the article lost remained

(B) As soon as damage or breakage of Government property is detected certain steps mentined under should be undertaken-

(a) A p r o m p t t h o ro u g h i n v e s t i g a t i o n i n t o t h e c a u s a t i o n o f b r e a k a g e o r d a m a g e s h o u l d be undertaken by the doctor-i n -charge of the WardSection or by the Head of the Institution

( b ) The investigating officer should draw conclusions as to whether the breakagedamage has been a result of-

(i) C a r e l e s s a n d n e g l i g e n t h a n d l i n g ( i i ) Unpredictable action of the patient for whom the equipment was

being used (iii) Accidental ( i v ) Manufacturing Defect

A report is then prepared in duplicate by person in charge of the article under question on the lsquobreakage and loss proformarsquo (See Annexure H)

16

These reports have to be signed by the investigating officer and are to be then submitted to competent authority for suitable action One copy which is returned is to be kept with the Stock Register In cases where the b r e a k a g e o r d a m a g e i s o f s u c h b i g g e r d e g r e e t h a t s atis factory repairs are not possible a n d if suc h b r e a k a ge o r da m a ge is o f su c h a de gr e e that satisfactory repairs are not possible and if such breakage or damage has been caused-

( i ) B y a G o v t s e r v a n t because of negligent or careless handling cost of the article should be recovered from him and credited to the treasury (ii)On account of reasons mentioned above that is un predictable action of the patient accidental or manufacturing defectthe article could be written offsubject to powers delegated to the concerned for such purpose

(C )Shortages detected during biannual physical verification of the Storeshave to be dealt in a similar manner

(D) it shall be at discretion of the competent authori ty (who is empowered to write off the loss) to reduce the amount of recovery upto 50 of the cost of article provided that before arriving at such a decisionhe has taken into account the following points (a) Normal life span of the article under questi on (b) Period for which it has been in use (c ) Condition of the article at the time of loss or damage and (d) Whether it was on account of careless or negligent act or not

XVI PROCEDURE FOR WRITING OFF STORES

(a) When any Stores become unserviceable otherwise than in ordinary course or by fair wear and tear their value should be treated as loss to the Government and in such cases cost should be recovered from the person responsible for his negligence

( b ) A s t r i c t w a t c h s h o u l d b e k e p t o n t h e m e d i c i n e s w h i ch bear an expiry date and if there is no likelihood of their being utilized locally intimation of the fact should be sent to Directorate of Health services and also to all o t h e r d i s t r i c t s s i m u l t a n e o u s l y s o t h a t t h e y c a n b e p u t t o u s e b e f o r e t h e expiry date In the event such a course is not followed and the Government i s p u t t o l o s s c o s t o f t h e m e d i c i n e i n q u e s t i o n s h a l l b e r e c o v e r e d f r o m t e defaulter

(c) For declaring articles as unserviceable a Committee of three members should be formed in each officeinstitution This Committee should examine each and every article brought before it and should record full reasons for condemning them and also say how the articles condemned have to be disposed of-whether by sale (by public auction) or otherwise

I f t he local Authority is not competent to write off the articles condemned by the Committee it should send the proposal to the higher authority for suitable a c t i o n

17

In Institutions where there is only one doctor a list of articles to be condemned should be p r e p a r e d a n d o r d e r s o n i t b e o b t a i n e d f r o m t h e inspecting authority during inspection

While preparing any list of articles for condemnation details regarding the date of purchase date of receipt period during which it remained in use usual life of the article and its purchase price should be noted against each item

( d ) The condemned articles should not be struck off the Stock Register till the competent authority sanctions its write ndashoff Details of Authority under which the article has been written off should be mentioned in stock register

XVII DISPOSAL OF WRITTEN OFF ARTICLES

Articles like linen should be torn into strips 10cm width so that they could be burnt or given to Government Jails for making carpets

Items like bed -pans bowlsurine po ts etc should be crushed and kept for auction

Brass utensils have also to be crushed to destroy their shape and could be either auctioned or after inviting rates from several dealers could be locally sold to highest bidder

In case when condemned ar ticles have to be sold by public auction they should be stored safely and the Government Auctioneer be intimated In case he expresses his inability to undertake the auction the officer should proceed with the auction departmentally The sale proceeds in either case should be credited to the Treasury as miscellaneous receipts under the Proper head of account

XVIII PHYSICAL VERIFICATION (a) The stocks held by officesinstitutions in various sections should be physically

verified twice a yearin the months o f April and October ( b ) Checking should be done by an officer other than te one who holds the charge of

Stores (c) Verification should be done in presence of officer holding the charge of Stores ( d ) All discrepancies found during the verification should be properly investigated

and accounted for

(j) Any excess detected during verification should be entered in the Stock book as Receipts with the remark ldquo Excess found on verificationrdquo

(ii)any shortage should be noted in issues column of lsquo Issuesrsquo described as lsquoshortage fou n d o n v e r i f i c a t i o n rsquo

XIX ANNUAL STORES ACCOUNT This account should be prepared according to the instruction issued from the department from time to time This should account for the outgoing financial year on the following lines -(a) Cost of the articles under various heads on the last day of the previous

year 18

( b ) Cost of the articles under the various Heads Received during the year (c) Cost of various articles written off during the year under review ( d ) Cost of the articles on the last day of the year or on the firs t d a y o f t h e

financial year following

19

Annexure A WardSection Indent Register No Issued on

Name of institution Page Folio No

Serial no Name of Article Quantity in Stock

Quantity required

Prepared by Approved by Recd by Note-Indenting Officer to sign and affix seal with name and

designation below the last item to avoid additions in one strokeno issues to be made by storesif Issue vouchers of

previous Indent has not been returned back by the WardSection

20

Annexure B Issue Voucher No (printed number)

Supplied to Wardsection Date

Indent no

Serial no Name of Article Quantity in Stock

Quantity required SB No

Stores-in MO Resident in Sign of charge charge WardSection

NurseCompounder Prepared by Recd Approved by by

Note-Indenting Officer to sign and affix seal with name and designation below the last item to avoid additions in one strokeno issues to be made by storesif Issue vouchers of previous Indent has not been

returned back 1st copy-Stores 2nd copy -Wardsection3rd copy-Tobe reurned to sores with Stock book entries

21

Annexure C

STOCK REGISTER FOR DEAD STOCKS

SERIAL NO DATE OF RECEIPT

Article with description

No of pieces Cost Details of

Bill Signature No Disposed

Date of disposal

Manner of Disposal

with Authority

Value realised Signature

1 2 3 4 5 6 7 8 9 10 11 12

P r e p a r e d B y C h e c k e d b y A p p r o v e d b y

Date Designation Name of Institution

22

Annexure D

STOCK REGISTER FOR EXPENDABLE ITEMS Name of article

Date

From where

received with cost

Quantity Signature To whom issued Quantity Balance Signature

1 2 3 4 5 6 7 8

23

Annexure E

Receipt amp Issue Register for WARDSSECTIONS (one or more pages as per requiremnt for each medicine)

NAME OF MEDICINE RECEIPT ISSUE

DATE Quantity In Stock

Date of

Issue

Issued toMention Bed no amp

quantity (in bracket) (For

Outdoor cases give Regd No)

Balance Signature

24

Annexure -F

OUTDOOR FREE MEDICINE SLIP In Duplicate

Name of Patient Registered No Date

Sr no Name of Medicine Quantity

Seal amp sign of doctor

25

Annexure-G

TREATMENT CARD

WARD NO

NAME OF PATIENT BED NO DATE amp TIME OF ADMISSION DATE amp TIME OF DISCHARGE

DATE MEDICINES PRESCRIBED SIGNATURE

26

ANNEXURE -H

PROFORMA FOR BREAKAGE amp LOSS

NAME OF OFFICEINSTITUTION DATE PLACE

SRNO NAME amp

DESCRIPTION OF ARTICLE

COST DATE OF PURCHASE

REASON CAUSE OF BREAKAGE

RECOMMENDATION OF INVESTIGATING AUTHORITY

Signature

Orders of the Competent Authority

Signature

27

Annexure ndash I Loss- Procedure for Reporting

1 The exact nature of the defalcation 2 The full extent of loss 3 The actual period covered by the defalcation 4 The defects in the negle c t o f r u le s by w hic h the loss was rendered possible

and circumstances which facilitated the defalcation 5 The names of the officials held personally or technically directly or

indirectly and wholly or partially responsible for the irregularity c o m m i t t e d i n t h e c a s e

6 Whether the c a s e a s b e e n J u d i c i a l l y t r i e d i n a c o u r t o r n o t i f s o c o p i e s ( i n duplicate) of the Judgment may please be furnished Copy of police report may also be furnished

7 The remedial measures adopted as safeguards against the losses hereafter 8 The prospects of re covery of the loss and he action taken to effect

recovery together with the amount recovered 9 Head of Account to which the Loss is debitable may be informed

Signature of Head of Office with seal

NoteA copy of this report is to be sent to AGMPThis is as per M P Finance Code Vol I

28

STORAGE AND STOCK MANAGEMENT

29

Foreword

The New Drug Policy 2009 is being implemented in the State of Madhya Pradesh

In order to have a proper procedure for Storage maintenance and expiry management of the drugs it is necessary to follow Good Storage Practices with Standard Modules for pharmacistStore keepers

Proper guidelines on Storage Practices can lead to better Stores and inventory upkeep with medicines being properly stored in racks with proper cleanliness and hygiene

This is a step towards storage maintenance and expiry management at the various stores in the state Looking forward to see that the heads of all health facilities take benefit from this module

D ir e c t o r M e d i c a l S e r v i c e s

30

INDEX

Sr No P a r t i c u l a r s P a g e

1 S T O R A G E A N D S T O C K M A N A G E M E N T 4

1 Quarantine and checking of stocks 11 Quarantine area 12 Checks to be carried out on new stocks

2 S t o r a g e 21 Need for proper storage 22 Different patterns of storage 23 Different means of storage 24 Temperatureclimatic conditions 25 Special storage of supplies 26 Storage and stability of medicines

3 Stock Control and Expiry Monitoring 31 Stock control 32 Stock rotation and expi r y m o n i t o r i n g

4 Other aspects of storage 41 Design of a storage area 42 Cleaning and maintenance 43 Product recalls 44 Returned goods

2 A p p e n d i x 1 Templates of letters for use if found not of Standard Quality [Frozen and expired goods ]

Frozen Drugs-ordered to return to the Suppliers-reg(New drug policy 2009)

Frozen Drugs-ordered to return to the Suppliers- for issue of gate pass after verification reg(New drug policy 2009) Stop instruction-reg(New drug policy

2009) Appendix II Material handling in drug stores

31

3 PROCUREMENT ndash Government Order Relating to

the Management of Stores

(Reproduced for reference material on basic

procedure in decentralized system followed by

Health facilities in 1977)

54

F L O W C H A R T S f o r a BI R D S E Y E V I E W o f

P R O C U R E M E N T

5 5

ACQUISITION OF STORES 6 1

PLACING OF ORDERS 6 2

RECEIPT OF STORES 6 2

CUSTODY 6 3

ISSUE OF STORES Maintenance of Stock Books

6 3

PROCEDURE OF INDENTING FOR WARD amp OTHER SECTIONS OF THE INSTITUTION

6 4

HOW OFTEN TO INDENT 6 5

EMERGENT INDENT 6 5

HOW TO INDENT 6 5

KEEPING OF RECORDS IN WARDS A N D S E C T I O N S

6 6

ACCOUNTABILITY OF DRUGS BROUGHT BY THE PATIENT OR RECEIVED IN DON A T I O N BY T H E WARDSECTION _IN - CHARGE

6 7

RESPONSIBILITY OF STORES AT VARIOUS LEVELS

6 7

DISTRIBUTION OF MEDICINES FROM OUTDOOR DEPARTMENT

6 7

LOSS BREAKAGE DAMAGE ETC 6 8

PROCEDURE FOR WRITING OFF STORES 6 9

DISPOSAL OF WRITTEN OFF ARTICLES 7 1

FORMATS TO BE USED 7 3 - 81

32

STORAGE AND STOCK MANAGEMENT The expiry periods of pharmaceutical products have meaning only if the products are stored under proper conditions otherwise products are likely to lose their potency before the actual date of expiry

A pharmacist is a vital link in the distribution chain for pharmaceutical products The medicinal products remain for a long period during the distribution cycle at the wholesaler and at retail pharmacies It is therefore very important to maintain proper storage conditions in these units

Every community pharmacy however large or s mall needs to store and manage its medicine stocks effectively There must be systems to ensure

middot bullbull Secure storage middot bullbull Clean and correct environmental conditions during storage middot bullbull Accurate and effective record keeping middot bullbull Effective stock rotation and expiry monitoring middot bullbull Effective fire and theft prevention middot bullbull Effective rodent pest control

For easier un derstanding this module has been divided into the following sections

1 Quarantine and checking of stocks 11 Quarantine area 12 Checks to be carried out on new stocks

2 S t o r a g e 21 Need for proper storage 22 Different patterns of storage 23 Different means of storage 24 Temperatureclimatic conditions 25 Special storage of supplies 26 Storage and stability of medicines

3 Stock Control and Expiry Monitoring 31 Stock control 3 2 S t o c k r o t a t i o n a n d e x p i r y m o n i t o r i n g

4 Other aspects of s t o r a g e 41 Design of a storage area 42 Cleaning and maintenance 43 Product recalls 44 Returned goods

33

1 QUARANTINE AND CHECKING OF STOCKS

11 Quarantine Area D r u g S t o r e pharmacies receive stoc k s f r o m su pplie r s a c c or d ing to pur c h a se o r d e r s T he stock that is received must be visually checked for quality and quantity The stocks must be kept in a separate area until the checking is done to avoid intermixing with existing stock This necessitates the presence of a separate area within the pharmacy w h e r e i n t h e storage and other checking of stocks can be performed This area is called the QUARANTINE AREA This area should be marked and identified adequately to distinguish it from other areas

The area may be marked using different means 1 ) A s m a l l board saying Quarantine on a separate table used exclusively if it is in the middle 2) A board on the wall if the table on which the quarantine stock is placed is against the wall

middot Stock received from wholesalers should be immediately transferred t o t h e Quarantine Area

middot In the Quarantine area the stock may be stored on racks shelves or in cupboards to prevent ingress of moisture dirt and other contaminants

middot Regular stocks from the pharmacy should not be left kept in the quarantine area Special care has to be taken in case of refrigerated medicines supplied by the suppliers so tha t the y do not remain in the quarantine area for long periods of time They should be immediately checked on receipt and transferred to areas for refrigerated storage s o a s to maintain the cold chain bull

Advantages of having a separate Quarantine Area middot Avoids cross mixing of newly arrived stock from existing stock till it is checked middot Lays stress on checking the quality of the stock received middot S to ck checking ensures t hat defective andor expired goods do not enter the storage areas

34

bullbull

bullbull

12 Checks to be carried out on new stock

Unpacking and checking stock

Supplies received should be unpacked and checked in the quarantine area Staff doing the checks should be adequatel y trained in what they have to check when stock arrives

Checking should be seen not simply as counting the units received but as a part of the quality assurance system bullThis should include middot Visually inspecting the packaging middot Checking the integrity of containers middot V erifying the completeness and leg ibility of la b e ls ( a ppr o ve d dr u g name strength any special storage instructions and expiry date)

bull

The expiry dat e should be checked to ensure that there is adequate shelf life remaining

Supplies should be individually checked using a checklist 35

Checklists

36

The wholesaler supplying the product should be notified immediately in case of any discrepancies ( and the details should be recorded in a register) and sent in a written format to the supplier It should include middot Missing boxes or cartons middot O p en tampered boxes or cartons middot Missing supplies middot Differences in the actual quantity and the quantity shown on the packing middot Additional medicines that had not been ordered but have been supplied middot D a m a g e d b r o k e n o r p oor quality medicines middot Any other discrepancies

The purchase invoices are an important aspect to be considered The invoiced documents should be signed and filed for reference as per the Drugs and Cosmetics Act and retained for at least 3years

If the wholesaler supplies medicines as an emergency without a bill or against a delivery challan

middot The supplies should be checked for integrity and inspected for damage middot The details of supplies received should be recorded middot The supplier should be asked t o send the bill as early as possible middot When the bill is received it should be checked against the details recorded and anomalies if any should be reported to the supplier

To keep a track of the received stock maintaining a S t o c k R e c o r d C a r d c a n b e very useful The entries in the stock record card can be made while checking the stock received STOCK BIN in the stores should have Stock record card

Maintaining a stock card for every product may not be very practical for a retail pharmacy however it could be maintained for costly medicines Nowadays it is much more practical and easier to maintain records using computers

The pharmacist should ensure that medicines manufacturedmarketed by a company are received only through an authorized distribution network of that company This is important to prevent spurious and counterfeit drugs from entering the pharmacy

37

2 STORAGE 21 The need for proper storage The storage of medicines and other products is an important requirement of Good Pharmacy Pr actice Appropriate storage of medicines is essential -

middot bullTo ensure that the potency is maintained middot bullTo prevent deteriorationspoilagedegradation middot bullTo ensuremaintain physical integrity

To ascertain that the quality and safety is maintained throughout their shelf life Storage requirements need to be considered on 2 aspects

a) Integrity of medicines Medicines should be stored in such a way so as to maintain their integrity and potency middot Maintain the right temperature required middot Protect from excessive humidity middot Keep medicines away from direct sunlight middot Protect from pests and rodents

b) Physical location middot Should be easy to locate middot Accessible middot Orderlysystematically placed

2 2 D i f f e r e n t p a t t e r n s o f s t o r a g e The pharmacist could follow any of the different patterns of storage The pattern of stora ge should be selected in such a way that it facilitates speedy and efficient dispensing of medicines

The pattern of storage could vary with each pharmacy experience usual practiceroutine of staff and the person-in charge and also depending on space av ailable turnover etc (i) The medicines could be stored c o m p a n y w i s e ie the medicines manufactured by one company should be grouped together and kept in one place Within each company shelfshelves the medicines may be placed in alphabetical order for easy and quick placement and removal Also bottles tubes boxes etc may be segregated within that shelf

38

(ii) The medicines may also be stored in a lphabe t ic al o r de r ie they are placed in order from left to right based on their name The first letter of the name is used to g r o u p t h e m e d i c i n e s t o g e t h e r a n d k e e p t h e m i n o n e l o c a t i o n I n s o m e p h a r m a c i e s a l l t h e strip packing are placed in drawers or boxes in alphabetical order each box or drawer containing strips of one particular alphabet This system ensures that the strips always remain e n c l o s e d i n t h e b o x e s d r a w e r s a n d a r e n o t e x p o s e d t o d u s t T h e d i s a d v a n t a g e i s that it might lead to mix -u p o f strips in the same drawer and it may cause a problem incase of similar looking strips in which case a wrong medicine may be dispensed Secondly cut strips lying around in the drawer may lose their identity if the batch n u m b e r andor expiry date is not seen on the cut portion of the strip

39

(iii) The medicines may be stored according to their therapeutic class ( e g a n t i b i o t i c s anti asthmatics or anti hypertensives) ie the medicines are kept together based on their pharmacological or therapeutic action

(iv) The medicines may be stockedsegregated according to dosage forms eg l i q u i d s (bottles) solid oral dosage forms eye drops rotacaps ointments etc all stored on separate shelves

Always Remember I Storage of prescription medicines should preferably be separate from OTC medicines OTC medicines especially those that a r e a d v e r t i s e d m a y b e d i s p l a y e d f o r c l i e n t s t o select or to ask questions about [OTC-O v e r t h e c o u n t e r ] II Storage according to temperatures is a must no matter which pattern of storage is followed Also within a particular storage area segregated storage may be maintained In a refrigerator for example medicines may be stored in trays racks and the freezer according to the temperature required

40

Whatever pattern of storage is selected all the personnel should ensure that middot The stocks are stored in an orderly manner middot The medicines are kept back in the same place from where they were removed middot All medicines are arranged neatly once in a while

middot The personnel should be careful while storing the medicines middot They should not throw the medicines haphazardly 23 Different means of storage

middot Within each temperature and security zone medicines must be stored so that they are easily accessible and protected against damage

middot Basic means of storage include shelves racks and drawers middot To prevent dust from entering the shelvesracks it is ideal to have glass

shutterssliding glass doors This can however be disadvantageous because accessibilityspeed is hampered in removing a product from the shelf because the glassshuttersliding glass has to be

41

opened m o v e d e v e r y t i m e a p r o d u c t h a s t o b e p i c k e d u p U s e o f a i r c o n d i t i o n e r s f o r t h e p h arm acy with a closed door at the e n t r a n c e o r a n a i r c u r t a i n c a n r e d u c e t h e d u s t problem In such cases the shelvesracks may be left o p e n

bull

middot Direct storage of cartons on the floor should be avoided because besides being an unhealthy practice the contents may also be damaged by moisture bull

middot Store medicines preferably in shelves with glass shutters for visibility middot Closed shelves further prevent dust from going in especially in India where most

pharmacies are located along busy roads middot Some medicines have to be refrigerated or stored in a cool or cold place Having a

refrigerator or two (as per the need of the pharmacy) is essential to store suc h medicines at temperatures mentioned on the label bull

42

Refrigeration middot All cold chain equipment should meet required standards middot Improvement in refrigeration technology has provided frost -free refrigerators

Pharmacists should opt for frost-free refrigerators as they are easy to maintain and protect printed packaging materials Conventional refrigerators may cause water falling from trays below the freezer on medicines stored in the refrigerator thus causing soggy labels

middot bull Frost-free refrigerators also provide separate and large compartments for the freezer portion (required for storing medicines needing sub-z e r o t e m p e r a t u r e ) and the main storage area with separate doors so that opening one door does not disturb the storage temperature in the other compartment

Care should be taken to keep the refrigerator on 24 hours a day It should not be switched off after working hours It is advisable to have an inverter connected to the refrigerator so that the refrigerator re mains working even when there is a power outage

middot The refrigerator door should be closed tightly middot The refrigerator door should not be left open for too long middot Space should be left between medicines stored in a refrigerator to allow air to

circulate middot The ref rigerator should be placed about an arms length away from the wall

This will increase air circulation thus not affecting the cooling within the refrigerator

middot Vaccines should not be stored on refrigerator door shelves as they are exposed to warmer temperatures each time the door is opened Vaccines should always be stored on the middle shelves of the refrigerator

middot Refrigerated medicines should not be left out of the refrigerator for more than a few minutes

43

middot Consumable products like juices energy drinks e t c s h o u l d n o t b e s t o r e d a l o n g with medicines in refrigerators If required they may be kept in a separate refrigerator

middot An adequate number of refrigerators should be planned to store the entire stocks requiring refrigerated storage

middot Adequate procedures should be followed for defrosting cleaning and maintenance of refrigerators

middot Icefreeze packs should be kept in the freezer compartment so that they can be used for transporting cold temperature medicines The packs can be given to clients along with the medicines requiring cold temperature storage so that the temperature is maintained till the client reaches home and can then put the medicines in a refrigerator) Freezer packs can also be used to keep medicines temporarily in case there is a power outage or refrigerator breakdown

Activity

Prepare a SOP (Standard operating procedure chart) for cleaning a refrigerator Discuss it with your staff finalize its maintenance once a month through AMC -A n n u a l Maintenance contract CMC - Comprehensive maintenance contract and put it up on the pharmacy refrigerator Put the Purchase Order details name of manufacturer Phone of Service Engineer and a register to login the Machine service and down timeService reports may be maintained properly

Refrigerator monitoring and maintenance

middot bullIt is important to carry out routine monitoring and maintenance of the refrigerators and to organize an effective repair system

middot bullThe temperature in the refrigerator must be monitored and recorded routinely at least once a day

middot Any breakdown must be reco rded including the period during which the medicines were exposed to uncontrolled temperatures Medicines may then be kept or discarded depending on the problem guidelines or the manufacturers advice

middot Cold chain monitor cards and devices in or on packages that change color or otherwise alert staff to potential damage assist in monitoring (These are likely to be introduced in India soon)

middot It is essential to have a contingency plan in place before a refrigerator breaks down An arrangement can be made to move the contents to a private refrigerator elsewhere in the community or to obtain a regular supply of ice packs until the defect is rectified

Put filled water bottles in the bottom half of the refrigerator door in order to provide cooling in the refri g e r a t o r w h e n t h e r e i s a p o w e r o u t a g e T h i s m i g h t t a k e c a r e o f t h e temperature when there is no current for a couple of hours If the power outage is expected to last for several hours special arrangements such as an inverter UPS have to be made to keep the refrigerator constantly running in the absence of electricity middot Defrost the refrigerator in case of excessive ice formation and preferably at regular

intervals Keep a record of the same

44

2 4 T e m p e r a t u r e c l i m a t i c c o n d i t i o n s

i) Temperature control middot The medicines in a pharmacy need to be stored at appropriate temperatures to

maintain their stability middot An air-conditioned environment where temperature can be controlled is

recommended for pharmacies Air conditioning offers the option of setting the t e m p e rature as per requirements

middot bullIt is ideal to have an air conditioner to maintain the temperature below 25 C as most medicines require storage below this temperature Secondly this temperature is pleasing to both the staff and the visiting customers too

middot In the absence of an air conditioner circulating fans may be used middot This need is felt even more in certain parts of India where temperatures soar above 45

C and some areas where it falls to sub zero temperatures In such cases temperature maintenance is essential to prevent deterioration of medicines due to unnecessary exposure to drastic temperature fluctuations

middot This need is felt even more in certain parts of India where temperatures soar above 45 C and some areas where it falls to sub zero temperat u r e s I n s u c h c a s e s temperature maintenance is essential to prevent deterioration of medicines due to unnecessary exposure to drastic temperature fluctuations

i i ) Humidity or moisture control Moisture or humidity can adversely affect the stability of me dicines such as tablets capsules powders

45

Gelatin capsules become soft and swell on absorption of moisture The drug content of tablets may undergo surface hydrolysis The presence of moisture may encourage the growth of microbes It is therefore essential to control humidity

To reduce the effect of humidity the following suggestions may be followed -middot Open the windows to allow air circulation Use a fan to circulate fresh (outside) air middot In humid climate a dehumidifier is useful for preventing mo i s t u r e d a m a g e ( i n t h e absence of an air conditioner) middot For bulk containers of tabletscapsules do not keep the container open for a long time and replace the lid or closure immediately after taking out the required number of medicines for dispensing middot Do not allow the medicines to touch the floor or the walls The walls may be damp and may cause moisture absorption damaging the product

middot Calibrated thermometers and manometers can be used to detect temperature and humidity in the pharmacy

middot Periodici t y of checking the temperature should be fixed middot The climatic conditions should be recorded and documented middot Temperature charts should be available for ready reference

Documentation is one of the core activities for achieving and maintaining quality It is one of the most essential components of validation Temperatures in various areas

46

including refrigerators should be recorded at a predetermined periodicity usually daily at the hottest time of the day and such documents should be preserved i i i ) Storage conditions A number of storage conditions are mentioned on the labels of medicinal products These conditions have to be properly interpreted and appropriately complied with

According to the Drugs and Cosmetics Rules 1945

1 The term cool place means a place having a temperature between 10 C and 25 C

2 The term cold place means a place having a temperature not exceeding 8 C In case of storage conditions for specific products please refer to Schedule P The Drugs and Cosmetic Rules 1 9 4 5

The Indian Pharmacopoeia specifies the following storage conditions -

Wherever the condition for storage is not specified medicines may be stored under normal temperature In a country like India however where normal temperatures soar to h i gh temperatures it is recommended that medicines be stored in a cool place

Activity Prepare a list of the storage requirements mentioned on the label of about 20 products in your pharmacy and check if the temperature is maintained

47

25 Special Storage o f s u p p l i e s If the product has no special instructions normal storage conditions apply This means storage in dry clean w e l l -ventilated premises at temperatures of +15 C to +25 C or depending on the climate up to +30 C (WHO1990) Storage instructions are product specific Different brands of the same generic drug may have different storage requirements as they may have different packaging or formulations It is essential to follow the product manufacturers storage instructions to the maximum extent possible Less stable medicines must be stored in specific conditions to maintain their quality or potency

The following products require special storage facilities

middot Products that must be kept frozen (usually vaccines and sera) middot Products sensitive to h eat an d r e q uir in g r e f r ig e r a tio n ( +2 C to +8 C) middot Products that have reduced shelf life at uncontrolled room temperature and need

mechanical ventilation or air conditioning middot Flammable products that require separate fireproof premises middot Products prone to theft o r m i s u s e

Products needing storage in a controlled environment -

The usable shelf life of the following products may be reduced if stored at uncontrolled humidity or at room temperature in hot climates -

middot Some injectables (eg adrenaline) Most injectable preparations are less stable than solid oral forms (tablets and capsules) Injectable preparations in solution are particularly unstable Many injections must be protected from light as well as heat

middot Intravenous fluids (particularly if packed in p lastic containers) middot Some suppositories pessaries creams and ointments These products may melt at

temperatures greater than 30 C Once this happens it is not advisable to use them because the active ingredient in the formula may get unevenly distributed

middot Products containing rubber latex cellulose or some plastics Condoms most sterile disposable medical devices and surgical products such as syringes needles and catheters require protection from excessive humidity and strong light and heat Any o f these conditions may make products brittle stained amp unusable Sterility cannot be assumed if packaging is damaged

In hot climates these products should be stored in the coolest place possible preferably with air conditioning or air circulation fans

48

Products needing freezing or refrigeration-middot Vaccines blood products and many other medicines lose potency if kept even for a

brief period at temperatures outside the recommended range For these products the cold chain must be maintained at every stage of the distribution system

middot Freezing is as damaging as high temperatures for some products including injectable contraceptives ergometrine insulin adrenaline and the DPT DT TT and Hepatitis B vaccines Such products therefore sho uld not be allowed to freeze (not be kept in the freezer compartment)

middot Short periods at room temperature (during transportation or local distribution for instance) may be acceptable for many products (such as ergometrine a n d i n s u l i n ) e v e n t h o u g h s u c h e x posure can to some extent reduce shelf life Other items such as vaccines should always be transported in cold boxes

Storage of insulin injections-

middot Insulin should always be stored in a refrigerator at the recommended temperature of 2 -8 C

middot Insulin should not be kept in the freezer compartment of the refrigerator middot Insulin should ideally be stored horizontally middot It should not be exposed to sunlight or excessive heat middot Insulin suspensions should not be used if the suspension cannot be properly

resuspended due to cake or clump formationbull

Controlled drugs -Narcotics (for example Pethidine injection morphine preparations) and other specified drugs that may be abused are governed by special legislation and regulations The following security measures are suggested in the pharmacy -middot A safe or reinforced double locked cabinet fitted with a light (preferably with a red

bulb) that comes on when the door is opened

49

middot A special register recording details of each receipt or issue with 2 signatures physi cal counting of medicines after each entry and signatures at handover takeover

middot Independent audit (by supervisors and drug inspectors)

Products prone to theft abuse or misuse -

Some medicinesproducts are particularly prone to theft abuse or misuse These include expensive medicines (eg insulin) certain antibiotics and products prone to abuse or misuse like psychotropics etc

Such medicinesproducts should be stored adequately They require stricter record keeping and more frequent stock taki ng than others Periodic audits should be carried out to check for consumption against actual recorded use (registers prescription records stock records etc) to expose any theft or misuse bull26 Storage and stability of medicines Medicines are not stab le indefinitely They are stable for a specific period of time sometimes for a brief period Poor storage conditions accelerate the drug degradation (decomposition) Temperature light and moisture are the most important contributing factors for drug instability It is important to identify and be aware of the potential for instability There is a need to comply with storage requirements to ensure quality medicines for patients It is also important to offer advice to patients too about appropriate storage o f medicines at home The dispensing label should state the storage condition required and be backed up by a verbal reminder especially where special storage is required bull

50

In case stability and storage problems are seen with formulations they should be reported immediately to the representative of the manufacturer and taken out of circulation till the stability problems have been resolved

The pharmacist can easily detect stability problems when products show change in appearance color odor settling of the product contents breaking of emulsions melting of creams oozing of contents from the containers and any such physical changes

3 STOCK CONTROL AND EXPIRY MONITORING 3 1 S t o c k C o n t r o l For economic reasons pharmacists do not like to have stock on their shelves for long periods of time The aim should always be to keep stock at a level that will just meet demand Normally most manufactured medicines have a long shelf life Even then it is essential that there is efficient stock rot ation so that the older stock is used first It is also a good practice to check the expiry date as an integral part of the dispensing process When short shelf life products are involved stock levels may have to be modified to prevent medicines regularl y expiring on the shelves

32 Stock rotation and expiry monitoring In order to avoid accumulation of expired and obsolete stock medicines should be stored and issued according to the following guidelines -middot The stock control system must record the ex p i r y d a t e a n d t h e d a t e o f r e c e i p t middot Stock must be stored so that earliest expiring batches are picked and issued first middot The First In First Out (FIFO) system - In this system the stock which is received

first is sold first This system however may not be useful for pharmacies because most of the stocks carry an expiry date For pharmacies the FEFO system is more practical

51

middot The First Expiry First Out (FEFO) system - In this system the stock having an earlier expiry is sold first The stock with longer shelf life should be placed farthest to the back (or at the bottom in case o f sta c k e d b oxe s) T h is is pa r tic u la r ly impor ta n t with products that have short shelf lives such as vaccines some vitamins antibiotics etc and reduces losses due to expiry

middot E x p i r y dates should be noted on the stock record upon receipt Stock nearing expiry should not be accepted unless it can be used before expiry

Computerization and expiry monitoring In the pharmacy computerization facilitates both checking stocks and expiry mo nitoring and helps-bullbullKeeping a check on products nearing expiry bullbullKeeping a check on non- moving and slow moving products bullbullTo facilitate the removal of medicines nearing expiry from shelves in time to send them back to the wholesaler or supplier

Periodic checking for expiry The expiry date for medicinal products is a critical aspect in pharmaceutical dispensing and due importance should be given to it Periodic checking for expiry of medicines will ensure that the patient will never receive products that have crossed their expiry date During periodical checking of expiry the personnel involved should remove medicines that are nearing expiry bullbullIn -house threshold periods should be set and followed for retrieval of such medicines from the shelves bullbullSuch medicines should be stored separately These should either be dispensed immediately (thus ensuring that they are used before the expiry date) o r t h e y s h o u l d b e returned to the suppliers bullbullA separate area should be designated (cupboard or shelf)marked[FROZEN ZONE] which is adequately marked EXPIRED GOODS- NOT FOR SALE to store all expired stocks FROZEN ZONE

52

Remember Expired medicines are a NATIONAL WASTE So stock only what you can sell Avoid expiries save precious medicines for the nation

Treatment and disposing of expired medicines bullbullProcedures need to be in place for the treatment of expired medicines bullbullThe expired medicines need to be collected and be sent back to the supplier or company for appropriate disposal bullbullRecords must be maintained for expired medicines and how they are disposed off bullbullIn case of medicines that are not returnable to suppliers procedures for disposal need to be followed by the pharmacy in conjunction with the FDA The following procedure can be followed if medicines cannot be returned to suppliers ( T h e b a s i c p h i l o s o p h y of appropriate disposal is to prevent their re- circulation and use) bullbullC u t t h e c o n t ainer in such a manner that the label is also cut In case of tablets and c a p s u l e s d e s t r o y them by disposing them in a bucket of water bullbullUse landfill procedures (deep burial into the ground as per stipulations of Medical Waste Disposal Act prevalent in the respective state) bullbullPour the liquids into the sink and wash away with sufficient quantity of water bullbullKeep a record of such disposal with full details of medicines destroyed Although these measures are usually adopted care has to be taken with such tr e a t m e n t a s studies have shown that flushing of medicines has resulted in tracessmall quantities of medicines being found in waterways and groundwater having potential health and environmental effects

4 O T H E R A S P E C T S 41 Design of storage areas The following important factors need to be considered in design of storage areas -middot The retail outlets in hot areas in summers should be air-conditioned Similarly in

a r e a s o f e x t r e m e c o l d t h e p r e m i s e s w o u l d r e q u i r e w a r m i n g e s p e c i a l l y i n w i n t e r s t o maintain cool temperatures The placement of air -conditioners and heating devices should be such that medicines are not directly exposed to the cold or heat

middot Due consideration should be given to storage requirements of formulations while designing shelves and cupboards in retail outlets Sufficient shelf height should be provided so that all liquid products can be stored vertically As far as possible the shelves should be covered with glass panels to protect medicines from dust and p r e v e n t r a p i d f l u c t u a t i o n s i n temperature

middot Medicines should be stored according to the storage instructions on the labels bullIt is ideal to have a door at the pharmacy entrance to prevent dust from coming in as well as reduceprevent cooled air from going out This may not however be considered feasiblepracticable by many pharmacy owners for fear that clients may not enter the pharmacy because the door may act as a barrier An air curtain is a good alternative to a door

middot There should be minimal direct sunlight falling on the products Particular consideration should be given to premises directly facing the sun

middot bullThe arrangement of lighting in the interior of the premises should also be in a manner that the lights are not focused on the products It has been shown that light causes not only chemical damage but also can catalyze physical changes like moisture uptak e by the products Care should be taken to ensure that only diffused light falls on them

53

middot As far as possible provision should be made for a temperature and humidity indicator device in a pharmacy These devices are now easily available

middot Stability studies o f m e d i c i n e s p a c k e d i n b l i s t e r s h a v e r e v e a l e d t h a t i f t h e s e a r e exposed to light they tend to absorb moisture It is therefore necessary to store them in suitable cartons so that the blisters are not exposed to light Pharmacists should do this even if the manufacturer has not provided cartons

middot Light and temperature sensitive products should not be stored on counters where the light is intense or direct and there is no protection from temperature and humidity

42 Cleaning and maintenance i) Cleaning of storage areas

The storage areas of the pharmacy should be cleaned periodically and cleanliness should be maintained at all times The Standard Operating Procedure for cleaning should be designed and followed accordingly Schedules for cleanups should be laid down and adequate cleaning equipment should be made available

Tips for maintaining cleanliness middot Provide clean pieces of cloth for wiping at various locations in the pharmacy

Replace with clean cloth at regular intervals middot Keep separate pieces of cloth for floors shelves and medicines middot Use a disinfectant andor soap solution to clean floors middot Ensure removal of dust and prevent accumulation of dirt middot Ensure removal of cobwebs middot Use a vacuum cleaner for cleaning areas not easily reachable middot T a k e c a r e t h at breakages are handled and cleared effectively middot Observe the factors leading to waste generation in the pharmacy and take appropriate

measures to tackle the problem middot Record all cleaning procedures performed and maintain all the documents required

For ex a m p l e -bullbullThe floor of the pharmacy may be swept with a broom and swabbed with soap water every morning bullbullThe floor may be swabbed with a disinfectant every week bullbullThe entire premises including shelves and cupboards may be cleaned with a cloth (to remove dust and to check for medicines approaching expiry date or expired medicines) every three months bullbullAll the steps followed should be r e c o r d e d

The floor shelves drawers have to be cleaned and a check should be kept on dust cobwebs spillages due to breakage etc It is therefore essential to have SOPs for cleaning laying down cleaning frequencies allotting responsibilities and maintaining a daily record in the logbook to document all these activities

54

While cleaning dust settled on dosage forms like bottles tubes etc should be removed Before dispensing the products should also be wiped to remove any dust settled during storage

For refrigerators bullbullDefrosting and cleaning should be done at regular intervals bullbullSwitch off the refrigerator while cleaning bullbullCleaning should be done quickly and stocks put back immediately

i i ) Pest control Pests are a serious problem in India where insects reptiles and rodents (eg cockroaches l i z a r d s r a t s s i l v e r f i s h (Deemak - in Hindi ) etc) may find access to the pharmacy storage areas Insects like ants and borer ants may often attack wood in the pharmacy causing d am ag e to shelves cupboardsPest c ontr o l in a p h a r m a c y c a n b e a d i f f i c u l t t a s k b u t t o avoid possible contamination and physical damage to stock it is necessary to keep pests out of the pharmacy premisesPest control measures should be implemented with proper p r e c a u t i o n s t a k i n g u t m o s t c a r e t o a v o i d contamination of medicines

55

Th e following pest control measures c a n be ta ke n f r om tim e to tim e -bullbullRat bait and traps can be placed at various locations bullbullInsecticutors can be used on a permanent basis bullbullInsecticidal sprays and repellants can be used from time to time

i i i ) Fire precautions

Combustible trash such as cartons boxes and other packing waste must not be allowed to accumulate in the store Waste should be deposited in appropriate waste bins and be d i s p o s e d o f f o n a d a i l y b a s i s

F i re detection and fire fighting equipment must be maintained and regularly inspected The pharmacy personnel should receive adequate training in fire fighting techniques and emergency actionFire prevention measures should include a prominently displayed ldquoNoSmokingrdquo sign careful handling and disposal of combustible waste materials and checking of electrical connections at regular intervals

iv) Security middot Doors shutters of the pharmacy should be strong and be fitted with secure locks middot Counters should be designed so that unauthorized personnelclients do not have

access to areas where prescription medicines are stored Access to such areas should be restricted to the pharmacy staff

middot All the pharmacy staff handling supplies should be accountable for their ac t i o n s

56

middot bullSpecial care must be taken in case of Schedule X and manufactured drugs (under NDPS Act) Such medicines should be kept under lock and key and the key should be kept with the Chief Pharmacist or i n h i s a b s e n c e t h e s e n i o r p h a r m a c i s t

v) Breakagespillage and damaged product Products that have been damagedspoiled during storage and handling spillages and broken glassware should be disposed off according to procedures laid down by the pharmacy Broken and damaged products s h o u l d b e p l a c e d i n a segregated area to be returned to the supplier

vi) Inspection Senior staff should inspect all pharmacy areas regularly The shelves and drawers should b e c h e c k e d d a i l y f o r signs of pests and dust Ceiling and walls should be checked for dirt and cobwebs Stock should be checked on a regular basis for deterioration due to climatic conditions

43 Product recalls Products found to be defective should be quickly recalled (withdrawn from the market) The instructions are generally issued either by the manufacturer or the regulatory agency The level of recall is determined by both the degree of risk and the extent of distribution of the product and in India is mainly directed at the distribution chain

On receiving the details of the defective substandard spurious batchbatches of a medicine to be recalled from the manufacturer or the stockist or the FDA the pharmacy should immediately check if the particular b a t c h i s i n s t o c k a n d i f s o s u s p e n d i t s s a l e immediately

Similarly if the regulatory authority in the country bans a particular medicine or FDC the pharmacy should immediately check and remove all the different brands of that particular medicine under consideration

The details of medicines and their batches to be recalled should be available in the q u a r a n t i n e a r e a w h e r e stocks are received and checked This is to ensure that such medicines do not come into the pharmacy

middot The pharmacy should develop SOPs for recall of medicines middot The pharmacy staff should be immediately informed about such medicines and

the details should be displayed in writing in a prominent place in the pharmacy middot Rapid action helps avoid unnecessary exposure to such medicines once the

problem has been d e t e c t e d middot The progress of the recall procedure in the pharmacy should be monitored every

few days to ensure complete compliance middot All stocks of the recalled products should be stored separately from the saleable

stock These can be stored in the expiry cupboard segregated from the expired goods and be appropriately labeled ldquoRecal l e d G o o d s - Not for Salerdquo

The supplier should be notified and asked to replace defective products middot All the details of the procedures followed should be duly recorded in a Recall

Register maintained specially for the purpose The register should include d etails such as -middot Date of the recall middot Nam e of the product

57

bullbull

middot Details of the product (name of manufacturer batch number expiry date) middot Nu m b er of units purchased sold a n d sto c k in ha nd middot Reason for recall middot Nam e of the supplier to whom produc ts w e r e returned along with the date and quantity middot Name and signature of the designated personnel carrying out the recall procedure and recording details middot Name and signature of the chief pharmacist verifying the recall procedures and recording details 4 4 Returned medicines

Medicines may be returned to the pharmacy by clients due to the following reasons -bull

bullbull Unused medicines bullbull Course not completed bullbull Therapy changed by doctor bullbull Side effects experienced by patient bull

bullbull DamagedDefective medicines bullbull Missing or defaced label bullbull Missing tablets in a stripblister bullbull Leakage in bottles bullbull Leakage in strips bull

bullbull Expired medicines

Appropriate SOPs should be framed and followed for their acceptancerefusal and disposal middot bull For unused medicines returned by clients the p harmacy personnel should verify

that these were purchased from their pharmacy They should then be checked for integrity of the packing the dosage form and the expiry date and verified with the client whether they were stored in appropriate conditions This again is at the discretion of each pharmacy

middot The damageddefective medicines returned to the pharmacy should be taken back and stored separately Existing stock of the same product should be checked for similar defects

middot Expired medicines should be accepted from clients at the discretion of the pharmacist and be immediately shifted to the expired goods cupboard These can be stored segregated from the pharmacys own expired goods and be appropriately labelled ldquoExpired Goods returned by clients- Not For Salerdquo

It is advisable not to accept returned medicines requiring cold chain storage (refrigeration) because it cannot be ensured that the cold chain was maintained when the medicines were in the hands of the patientclient middot Appropriate adjustments in t he stocks should be made for medicines

returnedexchanged to update the inventory middot The medicines should then be returned to the respective shelves middot A lsquoReturned Goodsrsquo register needs to be maintained to record all details of returned

medicines

R egister should include such details as-

58

middot N a m e o f t h e p a t i e n t middot Nam e of the product and quantity r e tu r n e d middot Product details such as the batch number and expiry date middot Condition in which received middot Reason for returning products middot Compensatory measures taken wi t h r e s p e c t t o c l i e n t middot Action taken with respect to product middot Name and signature of the personnel accepting the returned medicines and recording details middot Name and signature of the chief pharmacist verifying the recorded details

What the pharmacist would have learnt from this module The storage of medicines is a critical factor in the distribution cycle bullbull Stocks received by the pharmacy should be quarantined in a separate area and necessary checks s h o u ld be performed to ascertain the qua lity a nd quantity of stocks received bullbull Whatever pattern and means of storage used the products should be stored so as to maintain their potency and integrity bullbull Storage conditions should be monitored and maintained on a regular basis bullbull Optimum stock levels should be maintained and regularly monitored for expiry bullbull The design of storage areas should facilitate appropriate storage of medicines bullbull Cleanliness should be maintained in the pharmacy bullbull Adequate measures should be taken in case of returned medicines and recalled products

Optimum storage of medicines is mandatory whether at the distribution stage at the pharmacy or ultimately within the homes of patients The pharmacist has an important r o l e t o p l a y i n t h e s t o r a g e o f m e d i c i n e s i n m a i n t a i n i n g d r u g p o t ency and efficacy and thus facilitating optimum therapeutic benefits Good Pharmacy Practice - IPA -CDSCO - WHO Appendix I Quality Assurance Templates of letters for use if found not of Standard Quality [Frozen and expired goods ]

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated To Name of the Supplier with address

Sub Not of Standard Quality GoMP-Supply of Drugs and medicines-(Codename) Return of Stocks to the Suppliers-reg(New drug policy 2009) Previous letterinvoice ref Sl No Drug Code Drug name

Manufacturing date Expiry date

Supplier address

B a t c h n o

The above items of PO nodated was drawn by the Drug Inspector (Place) on (______________date) as a statutory sampling and declared ldquoNot of Standard

59

Qualityrdquo on -(______________date) by the Government Analyst for the following reasons

- ldquoThe product sample do not confirm to IP specification for (Drug codename with respect to the content of drugrdquo

- ldquoThe product has already been blacklisted by TNMSC on -(______________date) for the failure of (quantity) of batches of drug codenamerdquo

As per the clause of the te nde r d oc um e nt ldquo I f the sa mple s d o not c onf o r m to statutory standardsthe tenderer will be liable for relevant action under the existing laws and the entire stock in such batch should be taken back by the tenderer within a period of 30 days o f t h e r e c e i p t o f t h e l e t t e r f r o m t h e v e n u e

The stock shall be taken back at the expenses of the tendererthe Procurement Authority have the right to destroy such Not of Standard Quality if the tenderer does not take back the goods within the stipulated time

The Procuring Authority will arrange to destroy the Not of Standard Quality drugs within 90 days after the expiry of 30 days mentioned above without further notice and shall also collect demurrage charges calculated at the rate of 2 per week on the value of the drugs rejected till such destructionrdquo

Hence we regret to inform you that you will have to take back the stocks available of the abovesaid batch at your own cost from the drug stores where you have supplied the above batch

Kindly acknowledge the receipt of this reference at once

P r o c u r e m e n t A u t h o r i t y Seal and Stamp

Copy to Ref No dated

1 ) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated13082010

To

Sub Frozen Drugs-ordered to return to the Suppliers-reg(New drug policy 2009) Previous letterinvoice ref

The following products which were earlier frozen have now been ordered to return to suppliers directly with permission from the State drug Authority In this regard the suppliers have been instructed to take back their failed batch from the drug store of the stores Hence you are now instructed to return the following failed batches to the suppliers by obtaining proper authorization letter and acknowledgements from them

60

Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

Kindly acknowledge the receipt of this reference at once

Procurement Authority Seal and Stamp

Copy to

Ref No dated 2) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated14092010

To

Sub Frozen Drugs-ordered to return to the Suppliers- for issue of gate pass after verification reg(New drug policy 2009) Previous letterinvoice ref

The following products which were earlier frozen have now been released Hence they may be issued Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

Kindly acknowledge the receipt of this reference at once

Procurement Authority Seal and Stamp

Copy to

61

Ref No dated 3) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated

To

Sub Stop instruction-reg(New drug policy 2009) Previous letterinvoice ref

Until further instructions stop issue all the batches of the following item Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

You must intimate the available stock in the stores of the said batch Number to the Procurement Authority immediately Also retrieve quantity if already issued

Procurement Authority Seal and Stamp

Copy to

Ref No dated 4) HOD Procurement Office of

62

Appendix II Material handling in drug stores

Rack approx rates and dimensions

S No

Item Description UOM Approx Rate

1 MEDIUM DUTY RACK SIZE 2900 H X 3090 W X 800 D IN MM (AS PER SPECIFICATION)

Each 2499800

2 MEDIUM DUTY RACK ADD ON UNIT FOR SIZE OF SR NO2

Each 2243100

To locate a Box no 3 Rack no 14 in row3

SAMPLE OF RACK no Bin numbering -------------- S a y R K 1 4 R o w 3 B o x 1 6

SAMPLE LAYOUT of RACKS in a Drug Stores

63

Sample of another warehouse of distribution warehouse system

64

65

Slotted Angle racks with bin cards

66

Plastic Pallets

Plastic pallets ar e l i g h t w e i g h t l o w- c ost and exceed industry standards for strength and durability

NOTE A pallet has bottom deckboards (see sketch) A skid does not have bottom

67

deckboards

Battery Operated Stacker

Electric Stacker Ehh (Manual Push Type) - Manual drive - Lifting electrically with Battery 12 V 88 Ah - For loading and un-loading of trucks - Battery and loading device built - in - Battery charge gauge and charging current gauge Simple and Easy Operation - Lifting and Lowering electrically direct on steering arm - Pulling and pushing through steering arm - Electrically operated relief valve on hydraulic aggregate Safe Operation - Emergency Off Switch - Constant lowering speed - Protection through lowering brake valve - Overload protection through overload brake valve - Load chains covered preventing pinching threat - Electrically interlocking during loading process - Secured battery compartment opens upwardly - Stable buffering of the steering arm in upright position - In accordance with EWG Guidelines 89 240 - In accordance with VBG 12b Prevention of Accidents

Pallet Truck [ Top ]

68

----------------------------------------------------------------------------------------------------------------------------

For Transport Of All Goods On Pallets Safe and Easy Operation - through single hand operation Lifting moving

lowering with steering handle - neutral position of the hydraulic possible - overload pressure relief valve Long Service Life - robust co n s t r u c t i o n

- special hardened axles - hardened chromium plated ram - maintenance free Easy Maneuverability - through rubber steering rollers - nylon fork rollers

A h a n d t r o l l e y

69

Trolley with plastic bins for several items del ivery

70

Digital Weighing balances

Balances amp Scales EF Seriers Precision Electronic Balance

71

1

Ice lined Refrigerators

600 litres refrigrator

72

Walk in cooler

vacuum cleaner

73

tk fd dkykrhr vofk de ls de 112 okZ gks vkSj nokvksa dk iznk

FEFO in~fr ls fdk tkA bldk rkRiZ g gS First Expiry First Out

vFkkZr ftl nok Dlikjh igys gS mls igys brsquokw fdk tkA fn dksbZ

nok dkykrhr gksrh gS rks mls i`Fkd LFkku ij j[ksa o jkbZV vkWQ dh izfdzk

djsaA

10- nokvksa dk HkaMkjk OofLFkr fdk tkA nokvksa dks tehu esa ugh j[kk tk

mUgsa OofLFkr rjhds ls vkbZju jSd eas j[kk tk d izdkj dh nokbZ d

jSd eas j[kh tk rFkk jSd eas fcu dkMZ yxks tkA fcu dkMZ ls rkRiZ gS]

iksLV dkMZ dh lkbZt dk dkMZ ftlesa nokvksa dk uke mij fy[kk tk

Dlikjh fy[kh tkA rFkk dze ls frfFkokj nok brsquokw dh ek=k rFkk cpr

vafdr fdk tksaA

11- LVksj esa izfrfnu lkQ lQkbZ dh tksaA vuqiksxh lkeku tSls VwVk QwVk

QuhZpj midjk [kkyh dkVZwu ugh j[ksa tksA

12- dEIqVj rFkk vkWisjVj dh OoLFkk dj buosaVjh esustesaV fdk tksaA izRsd

15 fnu esa LVkWd cSysal fjiksZV cukbZ tksA

13- fcy lkr fnu eas lRkfir dj dkamV lsDrsquoku dks Hkstk tk rFkk nl fnu

esa Hkqxrku lqfufrsquopr djsa A

14- brsquokw fLyi dks d cqd ds i eas Niokk tk frac14izki layXufrac12 Annexure

AampB ftldh izFke izfr ejht dks nh tk ftls LVksj izHkkjh ladfyr

djsxk] frh izfr fpfdRld ds ikl jgsxhA bu fLyi ds vkkkj ij

lRkiu fdk tksa A

frac14MkW- -u-feRryfrac12 lapkyd LokLF lsoksa

eiznsrsquok

3

Directorate of Health Services

Satpura Bhawan

Madhya Pradesh

P R O C U R E M E N T ndash Government Order Relating to the Management of Stores

(Reproduced for reference material on basic procedure in decentralize d s y s t e m

followed by Health facilities in 1977)

Note This is for reference only as with New Drug Policy 2009 and systems going

changes all conditions may not hold good

MODULE I

4

FLOWCHARTS

middot EASY UNDERSTANDING OF THE PROCESS INITIATION O F T H E

PROCESS OF EMPOWERED PROCUREMENT WING-ldquoDRUG

C E L L-DIRECTORATE HEALTH SERVICESMADHYA PRADESHrdquo

middot UNDERSTANDING THE REQUIREMENT amp CHOOSING THE

CORRECT METHOD OF PROCUREMENT WITH APPROVAL OF

THE PURCHASE AND TECHNICAL COMMITTEE AS PER THE

DRUG POLICY

middot T HE TENDERING PROCESS

middot BRIEF OF THE PROCEDURE TO BE ADOPTED AFTER THE BIDS

ARE FINALISED

Flow Charts

P r o p o s e d S y s t e m I n i t i a t i o n

5

6

bull S y s t e m

7

bull System of Tendering at a Glance

8

DIRECTORATE OF HEALTH SERVICES MADH YA PRADESH

No Q E q p O c t 7 7 Bhopal the 2 6 th October 1977

(E x t r a c t e d f r o m t h e G O and reproduced f o r 2 0 1 0 -11 to have clearity on process of

procurement )

To

The Deans

The Divisional Joint Directors of Health

Th e J o int Director of Ayurveda

The Administrative officer ESISIndore

The Superintendents of Medical College Hospitals

The Superintendents of Special Hospitals

The Civil Surgeons

The District Family Welfare cum Health Officers

The Principals RHFWTC

MADHYA PRADESH

Subject -Rules Orders for management of stores

The Government of Madhya Pradesh in the department of Public Health and family Welfare have by their order No 305847795-2877MedIII dated the 13 th

October 1977 issued Rules for the management of STORES These come int o force from the day they are received by the officer-i n- charge of an institution

It is desired that these Rules be followed strictly both in lsquoletter and spiritrsquo and no explanations would be accepted for non-compliance

Sufficient number of printed cop ie s a r e be ing se n t to you f o r d istr ibution a m ongst your subordinate staff concerned with the subject

A C Gaur For Director Medical Services

Madhya Pradesh

9

ACQUISITION OF STORES

The word Stores used hereunder applies generally to all articles expendable as well as dead stock of the nature of plant machinery instruments furniture fixtures medicines linen etc etc

Any authority which is competent to incur contingent expenditure may sanction the purchase of stores required (sub ject to his d e le ga tion of f ina nc ia l pow e r s) pr o vide d the following rules are observed-

(a) A Purchase Committee comprising of atleast three Gazetted Officers is formed for approving quantity and quality of stores required

( b ) An enquiry for the articles purch ased should be sent out to various manufacturers and dealers if the total of the order is for Rs 15000 or less In case the purchase order is likely to exceed Rs 15000 ldquoopen tendersrdquo be called through news paper publicity ( f igur e s p e r ta in to 1 977)

(c) Stores s h o u l d n o t b e p u r c h a s e d i n s m a l l q u a n t i t i e s and often if such store is not perishable

( d ) Requirement of the whole year to be worked out a nd n o stor e sh ould b e p ur c h a se d in e x c e ss o f the requirement

(e) P u r c h a s e s h o u l d b e m a d e i n t h e m o s t e c o n o m i c a l manner but q ua lity ne e d not be sa c r if ic e d in the interest of the economy

(f) The details regarding the quality desired and expected purchase quantity should be mentioned in t h e e n q u i r y

(g) Purchase order should not be split up to avoid the ne c e ssity o f obta ining th e sa nc tio n o f t h e h i g h e r authority

( h ) The date and time of opening of the tender should also be published and in case the tenderers desire to be p r e se nt o n th e o c c a sio n th e y should b e a llo w e d t o d o s o

( i ) Mere initialing on the covers of the tenders is not sufficient All the Purchase committee members s h o u l d s i g n o n e a c h a n d e v e r y p a g e o f t e n d e r q u o t i n g t h e r a t e s A n y r a t e s w h i c h h a v e b e e n overwritten by the tenderer should not be c o n s i d e r e d u n l e s s t h e y b e a r t h e t e n d e r e r rsquo s s i g n a t u r e and subsequently signed by a member o f t h e Purchase committee

( j ) A list of tenders opened should be made out and t a l l i e d w i t h t h e o n e o f t h o s e r e c e i v e d i n t h e o f f i c e Such a list should be signed by all the members of the Purchase committee

( k ) A comparative statement is then made and lowest t e n d er i s a c c e p t e d s u b j e c t t o q u a l i t y o f f e r e d b e i n g

10

satisfactory Samples of non perishable articles should be preserved safely under lock and key for comparison till the contract for supply is in force

( l ) R e a s o n s for rejecting the lowest tender and accepting the h i g h e r o n e s h o u l d a l w a y s b e r e c o r d e d in writing by the Purchase Committee

(m) No reason for rejecting the lowest tender need to be communicated to the tenderer

( n ) Every purchase order should clearly mention that the articles ordered shall be accepted subject to t h e approval of the Purchase Committee

( o ) Rules regarding deposition of earnest money and security money should be observed

( p ) For emergent purchases in public interest when there is no time to observe Store Purchase Rules purchases should be made up to Rs 2 5000 (refers to year -1 9 7 7 ) a t a t i m e A s f a r a s p o s s i b l e t h i s practice should be avoided

II PLACING OF ORDERS (a) For medicines and such other articles which the Medical Stores Depot Bombay

supplies order be placed with them at a specified time ( b ) For articles not on the Bombay Stores Depot Bombay lsquolimitedrsquo or lsquoopenrsquo

tenders be invited as the case may require It would be preferable to place orders on the manufactures or their authorized distributors

(c) For placing the orders on PSUrsquos Laghu Udyog Nigam or Organisations approved by the State government no tender needs to be invited

( d ) Price preference upto 10 is available to Small Scale Industries of this State only(not applicable as per New drug policy 2010 -1 1 )

III RECEIPT OF STORES All materials received should be examined counted measured or weighed as the

case may be when the delivery is taken The stores thus verified be may be immediately entered in the stock register Book under proper headings and this fact should be recorded on the body of the bill mentioning the page number of the Stock Book It should also be mentioned whether the quality and the quantity are correct as per the requirement Soon after the receipt each item be stamped with the initials of the institution

IV CUSTODY

(a)The head of the institution should ensure suitable accommodation for keeping the stores with a view to prevent losses through theft accident fraud or otherwise

(b) Separate Stock Accounts should be kept of-( i ) D e a d S t o c k-such as plantmachineryfurniture equipmentinstruments

etc (ii) Expendible items such as medicineslinenrubber goods etc (iii) Perishable articles

(c ) all recepts and issues in the stores stock registers should be on the authorityand under the signature of a respon sible officer deputed for the purpose

11

V ISSUE OF STORES (a) When materials are issued from stock the officer -i n ndashcharge should ensure that the indent is in proper proforma (Annexure A) and the person taking delivery is an authorized one (b) The issue vouchers (Annexure B) for articles should be prepared in triplicate by one single stroke of pen The first copy will remain with the records of the stores The second and third copies will go to supplies The second copy will be retained by the person receiving the supplies and the third copy will be returned by the receiver to the stores after making entries of hisher stock book page number etc against each item ( C ) E v e r y t i m e i s s u e b e r e c o r d e d i n t h e s t o c k b o o k o f t h e s t o r e s w i t h s i g n a t u r e s o f t h e O f f i ce r i n -charge

(d) Every issue made from the Central Stores to other institution should show cost of article preparation of Annual Stores Account at a later date

VI Maintenance of Stock Books (a) Stock book should be kept under the charge of a responsible person and should be

saved from loss and destruction ( b ) While making new entries in the main Stores Stock book cost of each item

should be entered though this need not be done in the case of registers in Wards Operation Theatre Out door etc

(c) There should b e n o o v e r-writing or interpolation or smudging of figures Any f i g u r e i f i t i s t o b e c o r r e c t e d s h o u l d b e c l e a n l y c u t a c r o s s a n d t h e n e w f i g u r e should be written by its side or below it under proper attestation

( d ) Stock books should always have a page count(each page be numbered) A certificate showing the number of pages be given on the first and the last page under the signatures of a Gazetted Officer

(e) Receipts issues and balances should be worked out for every item and attested regularly by the Offic er-i n -Charge of the Stores

(f) In the receipt column details regarding the size quality and any special features if t h e r e b e s h o u l d b e r e c o r d e d e g i n t h e c a s e o f A l m i r a h i t s s i z e a n d w h e t h e r i t i s of Steel or Wood

(g) In the Stock-book of library Edition and the ye a r o f p ublic a tion of th e book should always be mentioned

( h ) In case of medicines having an expiry date a list of such medicines be made out and should be checked every week Two months prior to the date of expiry if the s t o c k i s s t i l l f o u n d s u f f i c iently high intimation should be given to Directorate of Health

(i) N o r e m o v a l o f d e a d s t o c k s h o u l d b e m a d e f r o m t h e s t o c k ndash B o o k u n l e s s s o a u t h o r i z e d b y t h e c o m p e t e n t A u t h o r i t y

(j) While making a new Stock book and transferring the stocks therein it should ensured that the page number of the old stock book is shown in the new stock b o o k a n d s i m i l a r l y p a g e n u m b e r o f t h e n e w s t o c k b o o k i s m e n t i o n e d i n t h e o l d one This has to be done to facilitate cross checking whenever desired

( k ) T h e r e h a v e t o b e d i f f e r e n t s e t s o f proforma for dead stocks and for expendable items

Annexure ldquoCrdquo is for former and Annexure ldquoDrdquo for the latter varieties

12

VII PROCEDURE OF INDENTING FOR WARD amp OTHER SECTIONS OF THE INSTITUTION

(a) There has to be an Indent Book with every such section wh ich receives and issues medicinesequipment

( b ) The indent shall be prepared by the nurse Compounded -i n -c ha r g e of th e WardSection in te single copy on the Performa (Annexure A)

(c) The indent so prepared will be signed by the medical officer resident ndash i n c h arge or in his absence by a doctor senior to him but associated with the ward section

( d ) The indent shall then be signed by the head of the institution (Superintendent or the Civil Surgeon as the c a se ma y be ) o r b y his A ssista n t if th e la tte r is so authorized in writing

(e) The indent book is then presented to the main Store for effecting issue (f) The Store will then prepare issue vouchers (Annex B) in triplicate as directed

in Paragraph V (b) supra The supplies and the Indent Book are taken back by the Ward Section- i n - charge after signing the first copy of the issue voucher

(g) Te supplies after arriving in the WardSection shall be entered on the WardSection stock register which is prepared on a proforma (Annexure E) and page number of each entry be shown o n t h e 2 n d a n d 3r d copies of the Issue

voucher The 2 n d copy of the voucher is to be retained in a file in the wardsection but the 3r d c o p y s h o u l d b e r e t u r n e d t o t h e s t o r e b e f o r e s u b m i t t i n g a fresh indent The Store has to be maintain separate files of the 3 r d copies Wardsection-wise

VIIIHOW OFTEN TO INDENT

(a) A wardsection ndash i n -charge should work out an average weekly expenditure of each item and efforts be made to replenish the WardSection stocks every week

( b ) T h e M a i n s t o r e i n o r d e r t o a v o i d h e a v y rush of work should fix a day of issue for each major specialty T w o or th r e e minor spe c ia ltie s c a n be gr o upe d f o r one day

IX EMERGENT INDENT It is very likely for unforeseen reasons either the weekly indent of WardSection stock might get exhausted earlier or something which was not there in the lsquoweekly indentrsquo is required Under such circumstances an ldquoEmergent Indentrdquo could be made out in the usual manner but under the signature of the Unit-i n- chargeconsultant and it must be countersigned by the head of the institution (and not by his assistant) These supplies have also to be entered in the wardSection stock books like others

13

X HOW TO INDENT

(a) The ward Section -i n - c h a r g e s h o u l d e n s u r e t h a t t h e s t o c k s u n d e r t h e i r c h a r g e a r e not unnecessarily large and only a realistic quantity is indented once a week

( b ) The indent should not be made out in the names of the patients or by bed numbers The indent should be for the Wardsection as a whole

XI KEEPING OF RECORDS IN WARDS AND SECTIONS

(a) A set p r o f o r m a ( A n n e x u r e E ) s h o u l d b e u s e d i n t h e w a r d s e c t i o n f o r s h o w i n g u p receipts and issues Balance of expenditure for each item to be drawn out every morning by nursecompounder in charge before writing out the Indent or before restarting work The medica l O f f ic e r r e side nt in c ha r g e sh ould a tte st th e e ntr ie s after satisfying himself- by random checking at least once a week

( b ) To support the above mentioned expenditure the Bed head Tickets (treatment charts) are very important Each medicine prescribed should be legibly written indicating the total quantity prescribed if the medicine is to be deleted from treatment the fact should be mentioned as to how much of the drug was issued to the patient before switching on to another drug The suggestion is that a separate treatment card be maintained for each indoor patient ( Annexure ndash G) A summary s h o w i n g t h e t o t a l a m o u n t o f t h e p r o p r i e t a r y d r u g s c o n s u m e d b y t h e p a t i e n t d u r i n g is hospital stay be worked out and noted in the summary card

XII ACCOUNT ABILITY OF DRUGS BROUGHT BY THE PATIENT OR RECEIVED IN DONATION BY THE WARDSECTION _IN -C H A R G E

The drugs receoived from the non - governmental sources should be entered on the receipts side of the WardSection Sto c k b ook a n d issu e s to show n a s in th e o the r cases on the issues side

XII RSPONSIBILITY OF STORES AT VARIOUS LEVELS (a) The head of the institution shall be held responsible for non-observance of

rulesprocedures laid down by the Government ( b ) The Medical officerresident in charge of the stores and the store keeper shall be

held responsible for any irregularity found in the stores or for ignoring the ordered pattern of working It shall be the duty of the Medical officer Incharge of the Stores to occasionally check the WardSection Stock-b o o k s t o t a l l y t h e e n t r i e s made in the 3 r d copy of the Issue vouchers [as laid down under V (b)supra ]

(c) The Medical officerresident in charge of the WardSection shall be responsible for irregularities in indenting stocksfor maintaining stocks much in excess of the req uirement and for improper keeping of BED HEAD TICKETS (treatment chartsCards)

( d ) The NurseCompounder ndash i n -charge of the WardSection shall be responsible for shortages in stocks for putting up inflated indents and or for not taking into account medicines b rought by the patientson the WardSection stock-books Heshe shall also be held responsible for ensuring proper distribution of medicines to each and every patient under his her charge

XIV DISTRIBUTION OF MEDICINES FROM OUTDOOR DEPARTMENT (A) ( a ) T h e r e are proprietary and non -proprietary medicines (like mixtures ointments

and lotions) which are to be distributed gratis to patients 14

(b) The Outdoor incharge shall arrange to maintain a stock of common drugs (list of which shall be prepared by the Head of t he Institution) and arrange to replenish the stocks once a week as has been laid down for wards (c) No proprietary drugs shall be issued on the prescription of an intern ( d ) The Head of the institution shall make out a list of drugs which can be issued on

the prescription of a houseman from the Outdoor stock without the countersignature of any other authority

(e) The residents can prescribe any drug from Outdoor stock without the counter signature of any authority

(f) The Consultants can prescribe any drug to any ot h e r o u t e r p a t i e n t e v e n i f i t i s n o t s t o c k e d i n t h e o u t d o o r b u t t h i s s h a l l h a v e t o b e c o u n t e r s i g n e d b y t h e h e a d o f t h e institution for issue from The Main Store

(B) T h e p e r s o n i n c h a r g e o f t h e O u t d o o r m e d i c i n e s s t o c k s h a l l k e e p a r e c o r d o f t h e q u a n t i t y o f t he medicines issued to each patient and instead of writing the name and other details e may only put down the Registration number of the patient and the quantity issued

At the end of the day he must work out the total expenditure of eac item and draw it s balance

The Medical officer in charge of the Stores and the Head of the institution sould check these records at least once a week and affix is signature to confirm their inspection

(C ) No proprietary medicine shall be issued without a valid issue s l i p ( A n n e x u r e- F)

(a) For Housemen the slip would be of brown colour ( b ) For residentsDemonstrators it shall be of pink color (c) For consultants the issue slip should be white ( d ) All issue slips should be printed and pages serially numbered (e) T h e d o c t o r s t o w h o m s u c h i s s u e s l i p s w o u l d b e i s s u e d s h a l l b e h e l d

responsible for their sa f e ke e ping a n d th e y w ould e n su r e tha t th e se slip s would be printed and serially numbered

(f) The doctors prescription slips (for issue from hospitals) of proprietary drugs be prepared in du plicate with the help of carbon One copy should be given to patient for obtaining medicines from the Stores and the other would remain in the Doctors Prescription Slip book

(g) Every issue Slip should be signed and below the signatures a rubber s t a m p s h o w i ng name and designation be affixed The Store people would n o t h o n o u r s l i p u n l e s s t h e n a m e o f p r e s c r i b e r i s c l e a r a n d h i s a t t e s t e d signatures are available to stores

( h ) The Store Staff would file prescription slips of each doctor separately to facilitate the scrutiny at least once a month by the Head of the Institution Such a Scrutiny would reveal over prescribing of or injudicious use of drugs

(C) Proprietary medicines should not be issued for more than three days requirement at a time The only exceptions being cases for cancer pulmonary tuberculosis and leprosy In exceptional cases an officer not below the rank of a Consultant can prescribe for more than 3 days but after the countersignatures of the Head of the Institution

15

XV LOSS BREAKAGE DAMAGE ETC

(A) Any loss of public money departmental revenue of receipts stamps stores or other property held by or on behalf of the Government caused by defalcation or otherwise discovered in an office or institution should immediately be reported by the officer concerned to the head of department through his immediate superior as well as to the Accountant General if the loss exceeds Rs 20000(fig of 1977) (for Proforma see Annexure I)even when such loss has been made good by the party responsible for it Such reports must be submitted as soon as possible and soon after suspicion arises that there has been a loss they must not be delayed while detailed enquiries are made

When the matter has been fully investigated further and complete report should be submitted of the nature and extent of loss showing the errors or neglect rules by which such loss showing the errors or neglect of rules by which such loss was rendered possible and prospects of effecting such recovery

The s ubmission of such a repot does n o t d e b a r t h e l o c a l a u t h o r i t i e s t a k i n g f u r t h e r a c t i o n which may be deemed necessary like handing over the case to the police

Every Government servant should realize fully and clearly that he will be held personally responsible for any loss sustained by the government through fraud and negligence on is part and that will also be held personally responsible for any loss arising from fraud or negligence on the part of any other Government servant to extent to which it may be shown that he has contributed to loss by his own action or negligence

A s s o o n a s s h o r t a g e i n s t o c k o r l o s s i s d i s c o v e r e d a p a r t f r o m r e p o r t i n g t h e m a t t e r a responsible officer should be deputed to investigate the matter

W h e r e t h e r e i s n o l i k e l i h o o d o f a d e l i b e r a t e t h e f t b u t l o s s i s a result of neglect onlythe loss should be made good by the person on whose charge or custody the article lost remained

(B) As soon as damage or breakage of Government property is detected certain steps mentined under should be undertaken-

(a) A p r o m p t t h o ro u g h i n v e s t i g a t i o n i n t o t h e c a u s a t i o n o f b r e a k a g e o r d a m a g e s h o u l d be undertaken by the doctor-i n -charge of the WardSection or by the Head of the Institution

( b ) The investigating officer should draw conclusions as to whether the breakagedamage has been a result of-

(i) C a r e l e s s a n d n e g l i g e n t h a n d l i n g ( i i ) Unpredictable action of the patient for whom the equipment was

being used (iii) Accidental ( i v ) Manufacturing Defect

A report is then prepared in duplicate by person in charge of the article under question on the lsquobreakage and loss proformarsquo (See Annexure H)

16

These reports have to be signed by the investigating officer and are to be then submitted to competent authority for suitable action One copy which is returned is to be kept with the Stock Register In cases where the b r e a k a g e o r d a m a g e i s o f s u c h b i g g e r d e g r e e t h a t s atis factory repairs are not possible a n d if suc h b r e a k a ge o r da m a ge is o f su c h a de gr e e that satisfactory repairs are not possible and if such breakage or damage has been caused-

( i ) B y a G o v t s e r v a n t because of negligent or careless handling cost of the article should be recovered from him and credited to the treasury (ii)On account of reasons mentioned above that is un predictable action of the patient accidental or manufacturing defectthe article could be written offsubject to powers delegated to the concerned for such purpose

(C )Shortages detected during biannual physical verification of the Storeshave to be dealt in a similar manner

(D) it shall be at discretion of the competent authori ty (who is empowered to write off the loss) to reduce the amount of recovery upto 50 of the cost of article provided that before arriving at such a decisionhe has taken into account the following points (a) Normal life span of the article under questi on (b) Period for which it has been in use (c ) Condition of the article at the time of loss or damage and (d) Whether it was on account of careless or negligent act or not

XVI PROCEDURE FOR WRITING OFF STORES

(a) When any Stores become unserviceable otherwise than in ordinary course or by fair wear and tear their value should be treated as loss to the Government and in such cases cost should be recovered from the person responsible for his negligence

( b ) A s t r i c t w a t c h s h o u l d b e k e p t o n t h e m e d i c i n e s w h i ch bear an expiry date and if there is no likelihood of their being utilized locally intimation of the fact should be sent to Directorate of Health services and also to all o t h e r d i s t r i c t s s i m u l t a n e o u s l y s o t h a t t h e y c a n b e p u t t o u s e b e f o r e t h e expiry date In the event such a course is not followed and the Government i s p u t t o l o s s c o s t o f t h e m e d i c i n e i n q u e s t i o n s h a l l b e r e c o v e r e d f r o m t e defaulter

(c) For declaring articles as unserviceable a Committee of three members should be formed in each officeinstitution This Committee should examine each and every article brought before it and should record full reasons for condemning them and also say how the articles condemned have to be disposed of-whether by sale (by public auction) or otherwise

I f t he local Authority is not competent to write off the articles condemned by the Committee it should send the proposal to the higher authority for suitable a c t i o n

17

In Institutions where there is only one doctor a list of articles to be condemned should be p r e p a r e d a n d o r d e r s o n i t b e o b t a i n e d f r o m t h e inspecting authority during inspection

While preparing any list of articles for condemnation details regarding the date of purchase date of receipt period during which it remained in use usual life of the article and its purchase price should be noted against each item

( d ) The condemned articles should not be struck off the Stock Register till the competent authority sanctions its write ndashoff Details of Authority under which the article has been written off should be mentioned in stock register

XVII DISPOSAL OF WRITTEN OFF ARTICLES

Articles like linen should be torn into strips 10cm width so that they could be burnt or given to Government Jails for making carpets

Items like bed -pans bowlsurine po ts etc should be crushed and kept for auction

Brass utensils have also to be crushed to destroy their shape and could be either auctioned or after inviting rates from several dealers could be locally sold to highest bidder

In case when condemned ar ticles have to be sold by public auction they should be stored safely and the Government Auctioneer be intimated In case he expresses his inability to undertake the auction the officer should proceed with the auction departmentally The sale proceeds in either case should be credited to the Treasury as miscellaneous receipts under the Proper head of account

XVIII PHYSICAL VERIFICATION (a) The stocks held by officesinstitutions in various sections should be physically

verified twice a yearin the months o f April and October ( b ) Checking should be done by an officer other than te one who holds the charge of

Stores (c) Verification should be done in presence of officer holding the charge of Stores ( d ) All discrepancies found during the verification should be properly investigated

and accounted for

(j) Any excess detected during verification should be entered in the Stock book as Receipts with the remark ldquo Excess found on verificationrdquo

(ii)any shortage should be noted in issues column of lsquo Issuesrsquo described as lsquoshortage fou n d o n v e r i f i c a t i o n rsquo

XIX ANNUAL STORES ACCOUNT This account should be prepared according to the instruction issued from the department from time to time This should account for the outgoing financial year on the following lines -(a) Cost of the articles under various heads on the last day of the previous

year 18

( b ) Cost of the articles under the various Heads Received during the year (c) Cost of various articles written off during the year under review ( d ) Cost of the articles on the last day of the year or on the firs t d a y o f t h e

financial year following

19

Annexure A WardSection Indent Register No Issued on

Name of institution Page Folio No

Serial no Name of Article Quantity in Stock

Quantity required

Prepared by Approved by Recd by Note-Indenting Officer to sign and affix seal with name and

designation below the last item to avoid additions in one strokeno issues to be made by storesif Issue vouchers of

previous Indent has not been returned back by the WardSection

20

Annexure B Issue Voucher No (printed number)

Supplied to Wardsection Date

Indent no

Serial no Name of Article Quantity in Stock

Quantity required SB No

Stores-in MO Resident in Sign of charge charge WardSection

NurseCompounder Prepared by Recd Approved by by

Note-Indenting Officer to sign and affix seal with name and designation below the last item to avoid additions in one strokeno issues to be made by storesif Issue vouchers of previous Indent has not been

returned back 1st copy-Stores 2nd copy -Wardsection3rd copy-Tobe reurned to sores with Stock book entries

21

Annexure C

STOCK REGISTER FOR DEAD STOCKS

SERIAL NO DATE OF RECEIPT

Article with description

No of pieces Cost Details of

Bill Signature No Disposed

Date of disposal

Manner of Disposal

with Authority

Value realised Signature

1 2 3 4 5 6 7 8 9 10 11 12

P r e p a r e d B y C h e c k e d b y A p p r o v e d b y

Date Designation Name of Institution

22

Annexure D

STOCK REGISTER FOR EXPENDABLE ITEMS Name of article

Date

From where

received with cost

Quantity Signature To whom issued Quantity Balance Signature

1 2 3 4 5 6 7 8

23

Annexure E

Receipt amp Issue Register for WARDSSECTIONS (one or more pages as per requiremnt for each medicine)

NAME OF MEDICINE RECEIPT ISSUE

DATE Quantity In Stock

Date of

Issue

Issued toMention Bed no amp

quantity (in bracket) (For

Outdoor cases give Regd No)

Balance Signature

24

Annexure -F

OUTDOOR FREE MEDICINE SLIP In Duplicate

Name of Patient Registered No Date

Sr no Name of Medicine Quantity

Seal amp sign of doctor

25

Annexure-G

TREATMENT CARD

WARD NO

NAME OF PATIENT BED NO DATE amp TIME OF ADMISSION DATE amp TIME OF DISCHARGE

DATE MEDICINES PRESCRIBED SIGNATURE

26

ANNEXURE -H

PROFORMA FOR BREAKAGE amp LOSS

NAME OF OFFICEINSTITUTION DATE PLACE

SRNO NAME amp

DESCRIPTION OF ARTICLE

COST DATE OF PURCHASE

REASON CAUSE OF BREAKAGE

RECOMMENDATION OF INVESTIGATING AUTHORITY

Signature

Orders of the Competent Authority

Signature

27

Annexure ndash I Loss- Procedure for Reporting

1 The exact nature of the defalcation 2 The full extent of loss 3 The actual period covered by the defalcation 4 The defects in the negle c t o f r u le s by w hic h the loss was rendered possible

and circumstances which facilitated the defalcation 5 The names of the officials held personally or technically directly or

indirectly and wholly or partially responsible for the irregularity c o m m i t t e d i n t h e c a s e

6 Whether the c a s e a s b e e n J u d i c i a l l y t r i e d i n a c o u r t o r n o t i f s o c o p i e s ( i n duplicate) of the Judgment may please be furnished Copy of police report may also be furnished

7 The remedial measures adopted as safeguards against the losses hereafter 8 The prospects of re covery of the loss and he action taken to effect

recovery together with the amount recovered 9 Head of Account to which the Loss is debitable may be informed

Signature of Head of Office with seal

NoteA copy of this report is to be sent to AGMPThis is as per M P Finance Code Vol I

28

STORAGE AND STOCK MANAGEMENT

29

Foreword

The New Drug Policy 2009 is being implemented in the State of Madhya Pradesh

In order to have a proper procedure for Storage maintenance and expiry management of the drugs it is necessary to follow Good Storage Practices with Standard Modules for pharmacistStore keepers

Proper guidelines on Storage Practices can lead to better Stores and inventory upkeep with medicines being properly stored in racks with proper cleanliness and hygiene

This is a step towards storage maintenance and expiry management at the various stores in the state Looking forward to see that the heads of all health facilities take benefit from this module

D ir e c t o r M e d i c a l S e r v i c e s

30

INDEX

Sr No P a r t i c u l a r s P a g e

1 S T O R A G E A N D S T O C K M A N A G E M E N T 4

1 Quarantine and checking of stocks 11 Quarantine area 12 Checks to be carried out on new stocks

2 S t o r a g e 21 Need for proper storage 22 Different patterns of storage 23 Different means of storage 24 Temperatureclimatic conditions 25 Special storage of supplies 26 Storage and stability of medicines

3 Stock Control and Expiry Monitoring 31 Stock control 32 Stock rotation and expi r y m o n i t o r i n g

4 Other aspects of storage 41 Design of a storage area 42 Cleaning and maintenance 43 Product recalls 44 Returned goods

2 A p p e n d i x 1 Templates of letters for use if found not of Standard Quality [Frozen and expired goods ]

Frozen Drugs-ordered to return to the Suppliers-reg(New drug policy 2009)

Frozen Drugs-ordered to return to the Suppliers- for issue of gate pass after verification reg(New drug policy 2009) Stop instruction-reg(New drug policy

2009) Appendix II Material handling in drug stores

31

3 PROCUREMENT ndash Government Order Relating to

the Management of Stores

(Reproduced for reference material on basic

procedure in decentralized system followed by

Health facilities in 1977)

54

F L O W C H A R T S f o r a BI R D S E Y E V I E W o f

P R O C U R E M E N T

5 5

ACQUISITION OF STORES 6 1

PLACING OF ORDERS 6 2

RECEIPT OF STORES 6 2

CUSTODY 6 3

ISSUE OF STORES Maintenance of Stock Books

6 3

PROCEDURE OF INDENTING FOR WARD amp OTHER SECTIONS OF THE INSTITUTION

6 4

HOW OFTEN TO INDENT 6 5

EMERGENT INDENT 6 5

HOW TO INDENT 6 5

KEEPING OF RECORDS IN WARDS A N D S E C T I O N S

6 6

ACCOUNTABILITY OF DRUGS BROUGHT BY THE PATIENT OR RECEIVED IN DON A T I O N BY T H E WARDSECTION _IN - CHARGE

6 7

RESPONSIBILITY OF STORES AT VARIOUS LEVELS

6 7

DISTRIBUTION OF MEDICINES FROM OUTDOOR DEPARTMENT

6 7

LOSS BREAKAGE DAMAGE ETC 6 8

PROCEDURE FOR WRITING OFF STORES 6 9

DISPOSAL OF WRITTEN OFF ARTICLES 7 1

FORMATS TO BE USED 7 3 - 81

32

STORAGE AND STOCK MANAGEMENT The expiry periods of pharmaceutical products have meaning only if the products are stored under proper conditions otherwise products are likely to lose their potency before the actual date of expiry

A pharmacist is a vital link in the distribution chain for pharmaceutical products The medicinal products remain for a long period during the distribution cycle at the wholesaler and at retail pharmacies It is therefore very important to maintain proper storage conditions in these units

Every community pharmacy however large or s mall needs to store and manage its medicine stocks effectively There must be systems to ensure

middot bullbull Secure storage middot bullbull Clean and correct environmental conditions during storage middot bullbull Accurate and effective record keeping middot bullbull Effective stock rotation and expiry monitoring middot bullbull Effective fire and theft prevention middot bullbull Effective rodent pest control

For easier un derstanding this module has been divided into the following sections

1 Quarantine and checking of stocks 11 Quarantine area 12 Checks to be carried out on new stocks

2 S t o r a g e 21 Need for proper storage 22 Different patterns of storage 23 Different means of storage 24 Temperatureclimatic conditions 25 Special storage of supplies 26 Storage and stability of medicines

3 Stock Control and Expiry Monitoring 31 Stock control 3 2 S t o c k r o t a t i o n a n d e x p i r y m o n i t o r i n g

4 Other aspects of s t o r a g e 41 Design of a storage area 42 Cleaning and maintenance 43 Product recalls 44 Returned goods

33

1 QUARANTINE AND CHECKING OF STOCKS

11 Quarantine Area D r u g S t o r e pharmacies receive stoc k s f r o m su pplie r s a c c or d ing to pur c h a se o r d e r s T he stock that is received must be visually checked for quality and quantity The stocks must be kept in a separate area until the checking is done to avoid intermixing with existing stock This necessitates the presence of a separate area within the pharmacy w h e r e i n t h e storage and other checking of stocks can be performed This area is called the QUARANTINE AREA This area should be marked and identified adequately to distinguish it from other areas

The area may be marked using different means 1 ) A s m a l l board saying Quarantine on a separate table used exclusively if it is in the middle 2) A board on the wall if the table on which the quarantine stock is placed is against the wall

middot Stock received from wholesalers should be immediately transferred t o t h e Quarantine Area

middot In the Quarantine area the stock may be stored on racks shelves or in cupboards to prevent ingress of moisture dirt and other contaminants

middot Regular stocks from the pharmacy should not be left kept in the quarantine area Special care has to be taken in case of refrigerated medicines supplied by the suppliers so tha t the y do not remain in the quarantine area for long periods of time They should be immediately checked on receipt and transferred to areas for refrigerated storage s o a s to maintain the cold chain bull

Advantages of having a separate Quarantine Area middot Avoids cross mixing of newly arrived stock from existing stock till it is checked middot Lays stress on checking the quality of the stock received middot S to ck checking ensures t hat defective andor expired goods do not enter the storage areas

34

bullbull

bullbull

12 Checks to be carried out on new stock

Unpacking and checking stock

Supplies received should be unpacked and checked in the quarantine area Staff doing the checks should be adequatel y trained in what they have to check when stock arrives

Checking should be seen not simply as counting the units received but as a part of the quality assurance system bullThis should include middot Visually inspecting the packaging middot Checking the integrity of containers middot V erifying the completeness and leg ibility of la b e ls ( a ppr o ve d dr u g name strength any special storage instructions and expiry date)

bull

The expiry dat e should be checked to ensure that there is adequate shelf life remaining

Supplies should be individually checked using a checklist 35

Checklists

36

The wholesaler supplying the product should be notified immediately in case of any discrepancies ( and the details should be recorded in a register) and sent in a written format to the supplier It should include middot Missing boxes or cartons middot O p en tampered boxes or cartons middot Missing supplies middot Differences in the actual quantity and the quantity shown on the packing middot Additional medicines that had not been ordered but have been supplied middot D a m a g e d b r o k e n o r p oor quality medicines middot Any other discrepancies

The purchase invoices are an important aspect to be considered The invoiced documents should be signed and filed for reference as per the Drugs and Cosmetics Act and retained for at least 3years

If the wholesaler supplies medicines as an emergency without a bill or against a delivery challan

middot The supplies should be checked for integrity and inspected for damage middot The details of supplies received should be recorded middot The supplier should be asked t o send the bill as early as possible middot When the bill is received it should be checked against the details recorded and anomalies if any should be reported to the supplier

To keep a track of the received stock maintaining a S t o c k R e c o r d C a r d c a n b e very useful The entries in the stock record card can be made while checking the stock received STOCK BIN in the stores should have Stock record card

Maintaining a stock card for every product may not be very practical for a retail pharmacy however it could be maintained for costly medicines Nowadays it is much more practical and easier to maintain records using computers

The pharmacist should ensure that medicines manufacturedmarketed by a company are received only through an authorized distribution network of that company This is important to prevent spurious and counterfeit drugs from entering the pharmacy

37

2 STORAGE 21 The need for proper storage The storage of medicines and other products is an important requirement of Good Pharmacy Pr actice Appropriate storage of medicines is essential -

middot bullTo ensure that the potency is maintained middot bullTo prevent deteriorationspoilagedegradation middot bullTo ensuremaintain physical integrity

To ascertain that the quality and safety is maintained throughout their shelf life Storage requirements need to be considered on 2 aspects

a) Integrity of medicines Medicines should be stored in such a way so as to maintain their integrity and potency middot Maintain the right temperature required middot Protect from excessive humidity middot Keep medicines away from direct sunlight middot Protect from pests and rodents

b) Physical location middot Should be easy to locate middot Accessible middot Orderlysystematically placed

2 2 D i f f e r e n t p a t t e r n s o f s t o r a g e The pharmacist could follow any of the different patterns of storage The pattern of stora ge should be selected in such a way that it facilitates speedy and efficient dispensing of medicines

The pattern of storage could vary with each pharmacy experience usual practiceroutine of staff and the person-in charge and also depending on space av ailable turnover etc (i) The medicines could be stored c o m p a n y w i s e ie the medicines manufactured by one company should be grouped together and kept in one place Within each company shelfshelves the medicines may be placed in alphabetical order for easy and quick placement and removal Also bottles tubes boxes etc may be segregated within that shelf

38

(ii) The medicines may also be stored in a lphabe t ic al o r de r ie they are placed in order from left to right based on their name The first letter of the name is used to g r o u p t h e m e d i c i n e s t o g e t h e r a n d k e e p t h e m i n o n e l o c a t i o n I n s o m e p h a r m a c i e s a l l t h e strip packing are placed in drawers or boxes in alphabetical order each box or drawer containing strips of one particular alphabet This system ensures that the strips always remain e n c l o s e d i n t h e b o x e s d r a w e r s a n d a r e n o t e x p o s e d t o d u s t T h e d i s a d v a n t a g e i s that it might lead to mix -u p o f strips in the same drawer and it may cause a problem incase of similar looking strips in which case a wrong medicine may be dispensed Secondly cut strips lying around in the drawer may lose their identity if the batch n u m b e r andor expiry date is not seen on the cut portion of the strip

39

(iii) The medicines may be stored according to their therapeutic class ( e g a n t i b i o t i c s anti asthmatics or anti hypertensives) ie the medicines are kept together based on their pharmacological or therapeutic action

(iv) The medicines may be stockedsegregated according to dosage forms eg l i q u i d s (bottles) solid oral dosage forms eye drops rotacaps ointments etc all stored on separate shelves

Always Remember I Storage of prescription medicines should preferably be separate from OTC medicines OTC medicines especially those that a r e a d v e r t i s e d m a y b e d i s p l a y e d f o r c l i e n t s t o select or to ask questions about [OTC-O v e r t h e c o u n t e r ] II Storage according to temperatures is a must no matter which pattern of storage is followed Also within a particular storage area segregated storage may be maintained In a refrigerator for example medicines may be stored in trays racks and the freezer according to the temperature required

40

Whatever pattern of storage is selected all the personnel should ensure that middot The stocks are stored in an orderly manner middot The medicines are kept back in the same place from where they were removed middot All medicines are arranged neatly once in a while

middot The personnel should be careful while storing the medicines middot They should not throw the medicines haphazardly 23 Different means of storage

middot Within each temperature and security zone medicines must be stored so that they are easily accessible and protected against damage

middot Basic means of storage include shelves racks and drawers middot To prevent dust from entering the shelvesracks it is ideal to have glass

shutterssliding glass doors This can however be disadvantageous because accessibilityspeed is hampered in removing a product from the shelf because the glassshuttersliding glass has to be

41

opened m o v e d e v e r y t i m e a p r o d u c t h a s t o b e p i c k e d u p U s e o f a i r c o n d i t i o n e r s f o r t h e p h arm acy with a closed door at the e n t r a n c e o r a n a i r c u r t a i n c a n r e d u c e t h e d u s t problem In such cases the shelvesracks may be left o p e n

bull

middot Direct storage of cartons on the floor should be avoided because besides being an unhealthy practice the contents may also be damaged by moisture bull

middot Store medicines preferably in shelves with glass shutters for visibility middot Closed shelves further prevent dust from going in especially in India where most

pharmacies are located along busy roads middot Some medicines have to be refrigerated or stored in a cool or cold place Having a

refrigerator or two (as per the need of the pharmacy) is essential to store suc h medicines at temperatures mentioned on the label bull

42

Refrigeration middot All cold chain equipment should meet required standards middot Improvement in refrigeration technology has provided frost -free refrigerators

Pharmacists should opt for frost-free refrigerators as they are easy to maintain and protect printed packaging materials Conventional refrigerators may cause water falling from trays below the freezer on medicines stored in the refrigerator thus causing soggy labels

middot bull Frost-free refrigerators also provide separate and large compartments for the freezer portion (required for storing medicines needing sub-z e r o t e m p e r a t u r e ) and the main storage area with separate doors so that opening one door does not disturb the storage temperature in the other compartment

Care should be taken to keep the refrigerator on 24 hours a day It should not be switched off after working hours It is advisable to have an inverter connected to the refrigerator so that the refrigerator re mains working even when there is a power outage

middot The refrigerator door should be closed tightly middot The refrigerator door should not be left open for too long middot Space should be left between medicines stored in a refrigerator to allow air to

circulate middot The ref rigerator should be placed about an arms length away from the wall

This will increase air circulation thus not affecting the cooling within the refrigerator

middot Vaccines should not be stored on refrigerator door shelves as they are exposed to warmer temperatures each time the door is opened Vaccines should always be stored on the middle shelves of the refrigerator

middot Refrigerated medicines should not be left out of the refrigerator for more than a few minutes

43

middot Consumable products like juices energy drinks e t c s h o u l d n o t b e s t o r e d a l o n g with medicines in refrigerators If required they may be kept in a separate refrigerator

middot An adequate number of refrigerators should be planned to store the entire stocks requiring refrigerated storage

middot Adequate procedures should be followed for defrosting cleaning and maintenance of refrigerators

middot Icefreeze packs should be kept in the freezer compartment so that they can be used for transporting cold temperature medicines The packs can be given to clients along with the medicines requiring cold temperature storage so that the temperature is maintained till the client reaches home and can then put the medicines in a refrigerator) Freezer packs can also be used to keep medicines temporarily in case there is a power outage or refrigerator breakdown

Activity

Prepare a SOP (Standard operating procedure chart) for cleaning a refrigerator Discuss it with your staff finalize its maintenance once a month through AMC -A n n u a l Maintenance contract CMC - Comprehensive maintenance contract and put it up on the pharmacy refrigerator Put the Purchase Order details name of manufacturer Phone of Service Engineer and a register to login the Machine service and down timeService reports may be maintained properly

Refrigerator monitoring and maintenance

middot bullIt is important to carry out routine monitoring and maintenance of the refrigerators and to organize an effective repair system

middot bullThe temperature in the refrigerator must be monitored and recorded routinely at least once a day

middot Any breakdown must be reco rded including the period during which the medicines were exposed to uncontrolled temperatures Medicines may then be kept or discarded depending on the problem guidelines or the manufacturers advice

middot Cold chain monitor cards and devices in or on packages that change color or otherwise alert staff to potential damage assist in monitoring (These are likely to be introduced in India soon)

middot It is essential to have a contingency plan in place before a refrigerator breaks down An arrangement can be made to move the contents to a private refrigerator elsewhere in the community or to obtain a regular supply of ice packs until the defect is rectified

Put filled water bottles in the bottom half of the refrigerator door in order to provide cooling in the refri g e r a t o r w h e n t h e r e i s a p o w e r o u t a g e T h i s m i g h t t a k e c a r e o f t h e temperature when there is no current for a couple of hours If the power outage is expected to last for several hours special arrangements such as an inverter UPS have to be made to keep the refrigerator constantly running in the absence of electricity middot Defrost the refrigerator in case of excessive ice formation and preferably at regular

intervals Keep a record of the same

44

2 4 T e m p e r a t u r e c l i m a t i c c o n d i t i o n s

i) Temperature control middot The medicines in a pharmacy need to be stored at appropriate temperatures to

maintain their stability middot An air-conditioned environment where temperature can be controlled is

recommended for pharmacies Air conditioning offers the option of setting the t e m p e rature as per requirements

middot bullIt is ideal to have an air conditioner to maintain the temperature below 25 C as most medicines require storage below this temperature Secondly this temperature is pleasing to both the staff and the visiting customers too

middot In the absence of an air conditioner circulating fans may be used middot This need is felt even more in certain parts of India where temperatures soar above 45

C and some areas where it falls to sub zero temperatures In such cases temperature maintenance is essential to prevent deterioration of medicines due to unnecessary exposure to drastic temperature fluctuations

middot This need is felt even more in certain parts of India where temperatures soar above 45 C and some areas where it falls to sub zero temperat u r e s I n s u c h c a s e s temperature maintenance is essential to prevent deterioration of medicines due to unnecessary exposure to drastic temperature fluctuations

i i ) Humidity or moisture control Moisture or humidity can adversely affect the stability of me dicines such as tablets capsules powders

45

Gelatin capsules become soft and swell on absorption of moisture The drug content of tablets may undergo surface hydrolysis The presence of moisture may encourage the growth of microbes It is therefore essential to control humidity

To reduce the effect of humidity the following suggestions may be followed -middot Open the windows to allow air circulation Use a fan to circulate fresh (outside) air middot In humid climate a dehumidifier is useful for preventing mo i s t u r e d a m a g e ( i n t h e absence of an air conditioner) middot For bulk containers of tabletscapsules do not keep the container open for a long time and replace the lid or closure immediately after taking out the required number of medicines for dispensing middot Do not allow the medicines to touch the floor or the walls The walls may be damp and may cause moisture absorption damaging the product

middot Calibrated thermometers and manometers can be used to detect temperature and humidity in the pharmacy

middot Periodici t y of checking the temperature should be fixed middot The climatic conditions should be recorded and documented middot Temperature charts should be available for ready reference

Documentation is one of the core activities for achieving and maintaining quality It is one of the most essential components of validation Temperatures in various areas

46

including refrigerators should be recorded at a predetermined periodicity usually daily at the hottest time of the day and such documents should be preserved i i i ) Storage conditions A number of storage conditions are mentioned on the labels of medicinal products These conditions have to be properly interpreted and appropriately complied with

According to the Drugs and Cosmetics Rules 1945

1 The term cool place means a place having a temperature between 10 C and 25 C

2 The term cold place means a place having a temperature not exceeding 8 C In case of storage conditions for specific products please refer to Schedule P The Drugs and Cosmetic Rules 1 9 4 5

The Indian Pharmacopoeia specifies the following storage conditions -

Wherever the condition for storage is not specified medicines may be stored under normal temperature In a country like India however where normal temperatures soar to h i gh temperatures it is recommended that medicines be stored in a cool place

Activity Prepare a list of the storage requirements mentioned on the label of about 20 products in your pharmacy and check if the temperature is maintained

47

25 Special Storage o f s u p p l i e s If the product has no special instructions normal storage conditions apply This means storage in dry clean w e l l -ventilated premises at temperatures of +15 C to +25 C or depending on the climate up to +30 C (WHO1990) Storage instructions are product specific Different brands of the same generic drug may have different storage requirements as they may have different packaging or formulations It is essential to follow the product manufacturers storage instructions to the maximum extent possible Less stable medicines must be stored in specific conditions to maintain their quality or potency

The following products require special storage facilities

middot Products that must be kept frozen (usually vaccines and sera) middot Products sensitive to h eat an d r e q uir in g r e f r ig e r a tio n ( +2 C to +8 C) middot Products that have reduced shelf life at uncontrolled room temperature and need

mechanical ventilation or air conditioning middot Flammable products that require separate fireproof premises middot Products prone to theft o r m i s u s e

Products needing storage in a controlled environment -

The usable shelf life of the following products may be reduced if stored at uncontrolled humidity or at room temperature in hot climates -

middot Some injectables (eg adrenaline) Most injectable preparations are less stable than solid oral forms (tablets and capsules) Injectable preparations in solution are particularly unstable Many injections must be protected from light as well as heat

middot Intravenous fluids (particularly if packed in p lastic containers) middot Some suppositories pessaries creams and ointments These products may melt at

temperatures greater than 30 C Once this happens it is not advisable to use them because the active ingredient in the formula may get unevenly distributed

middot Products containing rubber latex cellulose or some plastics Condoms most sterile disposable medical devices and surgical products such as syringes needles and catheters require protection from excessive humidity and strong light and heat Any o f these conditions may make products brittle stained amp unusable Sterility cannot be assumed if packaging is damaged

In hot climates these products should be stored in the coolest place possible preferably with air conditioning or air circulation fans

48

Products needing freezing or refrigeration-middot Vaccines blood products and many other medicines lose potency if kept even for a

brief period at temperatures outside the recommended range For these products the cold chain must be maintained at every stage of the distribution system

middot Freezing is as damaging as high temperatures for some products including injectable contraceptives ergometrine insulin adrenaline and the DPT DT TT and Hepatitis B vaccines Such products therefore sho uld not be allowed to freeze (not be kept in the freezer compartment)

middot Short periods at room temperature (during transportation or local distribution for instance) may be acceptable for many products (such as ergometrine a n d i n s u l i n ) e v e n t h o u g h s u c h e x posure can to some extent reduce shelf life Other items such as vaccines should always be transported in cold boxes

Storage of insulin injections-

middot Insulin should always be stored in a refrigerator at the recommended temperature of 2 -8 C

middot Insulin should not be kept in the freezer compartment of the refrigerator middot Insulin should ideally be stored horizontally middot It should not be exposed to sunlight or excessive heat middot Insulin suspensions should not be used if the suspension cannot be properly

resuspended due to cake or clump formationbull

Controlled drugs -Narcotics (for example Pethidine injection morphine preparations) and other specified drugs that may be abused are governed by special legislation and regulations The following security measures are suggested in the pharmacy -middot A safe or reinforced double locked cabinet fitted with a light (preferably with a red

bulb) that comes on when the door is opened

49

middot A special register recording details of each receipt or issue with 2 signatures physi cal counting of medicines after each entry and signatures at handover takeover

middot Independent audit (by supervisors and drug inspectors)

Products prone to theft abuse or misuse -

Some medicinesproducts are particularly prone to theft abuse or misuse These include expensive medicines (eg insulin) certain antibiotics and products prone to abuse or misuse like psychotropics etc

Such medicinesproducts should be stored adequately They require stricter record keeping and more frequent stock taki ng than others Periodic audits should be carried out to check for consumption against actual recorded use (registers prescription records stock records etc) to expose any theft or misuse bull26 Storage and stability of medicines Medicines are not stab le indefinitely They are stable for a specific period of time sometimes for a brief period Poor storage conditions accelerate the drug degradation (decomposition) Temperature light and moisture are the most important contributing factors for drug instability It is important to identify and be aware of the potential for instability There is a need to comply with storage requirements to ensure quality medicines for patients It is also important to offer advice to patients too about appropriate storage o f medicines at home The dispensing label should state the storage condition required and be backed up by a verbal reminder especially where special storage is required bull

50

In case stability and storage problems are seen with formulations they should be reported immediately to the representative of the manufacturer and taken out of circulation till the stability problems have been resolved

The pharmacist can easily detect stability problems when products show change in appearance color odor settling of the product contents breaking of emulsions melting of creams oozing of contents from the containers and any such physical changes

3 STOCK CONTROL AND EXPIRY MONITORING 3 1 S t o c k C o n t r o l For economic reasons pharmacists do not like to have stock on their shelves for long periods of time The aim should always be to keep stock at a level that will just meet demand Normally most manufactured medicines have a long shelf life Even then it is essential that there is efficient stock rot ation so that the older stock is used first It is also a good practice to check the expiry date as an integral part of the dispensing process When short shelf life products are involved stock levels may have to be modified to prevent medicines regularl y expiring on the shelves

32 Stock rotation and expiry monitoring In order to avoid accumulation of expired and obsolete stock medicines should be stored and issued according to the following guidelines -middot The stock control system must record the ex p i r y d a t e a n d t h e d a t e o f r e c e i p t middot Stock must be stored so that earliest expiring batches are picked and issued first middot The First In First Out (FIFO) system - In this system the stock which is received

first is sold first This system however may not be useful for pharmacies because most of the stocks carry an expiry date For pharmacies the FEFO system is more practical

51

middot The First Expiry First Out (FEFO) system - In this system the stock having an earlier expiry is sold first The stock with longer shelf life should be placed farthest to the back (or at the bottom in case o f sta c k e d b oxe s) T h is is pa r tic u la r ly impor ta n t with products that have short shelf lives such as vaccines some vitamins antibiotics etc and reduces losses due to expiry

middot E x p i r y dates should be noted on the stock record upon receipt Stock nearing expiry should not be accepted unless it can be used before expiry

Computerization and expiry monitoring In the pharmacy computerization facilitates both checking stocks and expiry mo nitoring and helps-bullbullKeeping a check on products nearing expiry bullbullKeeping a check on non- moving and slow moving products bullbullTo facilitate the removal of medicines nearing expiry from shelves in time to send them back to the wholesaler or supplier

Periodic checking for expiry The expiry date for medicinal products is a critical aspect in pharmaceutical dispensing and due importance should be given to it Periodic checking for expiry of medicines will ensure that the patient will never receive products that have crossed their expiry date During periodical checking of expiry the personnel involved should remove medicines that are nearing expiry bullbullIn -house threshold periods should be set and followed for retrieval of such medicines from the shelves bullbullSuch medicines should be stored separately These should either be dispensed immediately (thus ensuring that they are used before the expiry date) o r t h e y s h o u l d b e returned to the suppliers bullbullA separate area should be designated (cupboard or shelf)marked[FROZEN ZONE] which is adequately marked EXPIRED GOODS- NOT FOR SALE to store all expired stocks FROZEN ZONE

52

Remember Expired medicines are a NATIONAL WASTE So stock only what you can sell Avoid expiries save precious medicines for the nation

Treatment and disposing of expired medicines bullbullProcedures need to be in place for the treatment of expired medicines bullbullThe expired medicines need to be collected and be sent back to the supplier or company for appropriate disposal bullbullRecords must be maintained for expired medicines and how they are disposed off bullbullIn case of medicines that are not returnable to suppliers procedures for disposal need to be followed by the pharmacy in conjunction with the FDA The following procedure can be followed if medicines cannot be returned to suppliers ( T h e b a s i c p h i l o s o p h y of appropriate disposal is to prevent their re- circulation and use) bullbullC u t t h e c o n t ainer in such a manner that the label is also cut In case of tablets and c a p s u l e s d e s t r o y them by disposing them in a bucket of water bullbullUse landfill procedures (deep burial into the ground as per stipulations of Medical Waste Disposal Act prevalent in the respective state) bullbullPour the liquids into the sink and wash away with sufficient quantity of water bullbullKeep a record of such disposal with full details of medicines destroyed Although these measures are usually adopted care has to be taken with such tr e a t m e n t a s studies have shown that flushing of medicines has resulted in tracessmall quantities of medicines being found in waterways and groundwater having potential health and environmental effects

4 O T H E R A S P E C T S 41 Design of storage areas The following important factors need to be considered in design of storage areas -middot The retail outlets in hot areas in summers should be air-conditioned Similarly in

a r e a s o f e x t r e m e c o l d t h e p r e m i s e s w o u l d r e q u i r e w a r m i n g e s p e c i a l l y i n w i n t e r s t o maintain cool temperatures The placement of air -conditioners and heating devices should be such that medicines are not directly exposed to the cold or heat

middot Due consideration should be given to storage requirements of formulations while designing shelves and cupboards in retail outlets Sufficient shelf height should be provided so that all liquid products can be stored vertically As far as possible the shelves should be covered with glass panels to protect medicines from dust and p r e v e n t r a p i d f l u c t u a t i o n s i n temperature

middot Medicines should be stored according to the storage instructions on the labels bullIt is ideal to have a door at the pharmacy entrance to prevent dust from coming in as well as reduceprevent cooled air from going out This may not however be considered feasiblepracticable by many pharmacy owners for fear that clients may not enter the pharmacy because the door may act as a barrier An air curtain is a good alternative to a door

middot There should be minimal direct sunlight falling on the products Particular consideration should be given to premises directly facing the sun

middot bullThe arrangement of lighting in the interior of the premises should also be in a manner that the lights are not focused on the products It has been shown that light causes not only chemical damage but also can catalyze physical changes like moisture uptak e by the products Care should be taken to ensure that only diffused light falls on them

53

middot As far as possible provision should be made for a temperature and humidity indicator device in a pharmacy These devices are now easily available

middot Stability studies o f m e d i c i n e s p a c k e d i n b l i s t e r s h a v e r e v e a l e d t h a t i f t h e s e a r e exposed to light they tend to absorb moisture It is therefore necessary to store them in suitable cartons so that the blisters are not exposed to light Pharmacists should do this even if the manufacturer has not provided cartons

middot Light and temperature sensitive products should not be stored on counters where the light is intense or direct and there is no protection from temperature and humidity

42 Cleaning and maintenance i) Cleaning of storage areas

The storage areas of the pharmacy should be cleaned periodically and cleanliness should be maintained at all times The Standard Operating Procedure for cleaning should be designed and followed accordingly Schedules for cleanups should be laid down and adequate cleaning equipment should be made available

Tips for maintaining cleanliness middot Provide clean pieces of cloth for wiping at various locations in the pharmacy

Replace with clean cloth at regular intervals middot Keep separate pieces of cloth for floors shelves and medicines middot Use a disinfectant andor soap solution to clean floors middot Ensure removal of dust and prevent accumulation of dirt middot Ensure removal of cobwebs middot Use a vacuum cleaner for cleaning areas not easily reachable middot T a k e c a r e t h at breakages are handled and cleared effectively middot Observe the factors leading to waste generation in the pharmacy and take appropriate

measures to tackle the problem middot Record all cleaning procedures performed and maintain all the documents required

For ex a m p l e -bullbullThe floor of the pharmacy may be swept with a broom and swabbed with soap water every morning bullbullThe floor may be swabbed with a disinfectant every week bullbullThe entire premises including shelves and cupboards may be cleaned with a cloth (to remove dust and to check for medicines approaching expiry date or expired medicines) every three months bullbullAll the steps followed should be r e c o r d e d

The floor shelves drawers have to be cleaned and a check should be kept on dust cobwebs spillages due to breakage etc It is therefore essential to have SOPs for cleaning laying down cleaning frequencies allotting responsibilities and maintaining a daily record in the logbook to document all these activities

54

While cleaning dust settled on dosage forms like bottles tubes etc should be removed Before dispensing the products should also be wiped to remove any dust settled during storage

For refrigerators bullbullDefrosting and cleaning should be done at regular intervals bullbullSwitch off the refrigerator while cleaning bullbullCleaning should be done quickly and stocks put back immediately

i i ) Pest control Pests are a serious problem in India where insects reptiles and rodents (eg cockroaches l i z a r d s r a t s s i l v e r f i s h (Deemak - in Hindi ) etc) may find access to the pharmacy storage areas Insects like ants and borer ants may often attack wood in the pharmacy causing d am ag e to shelves cupboardsPest c ontr o l in a p h a r m a c y c a n b e a d i f f i c u l t t a s k b u t t o avoid possible contamination and physical damage to stock it is necessary to keep pests out of the pharmacy premisesPest control measures should be implemented with proper p r e c a u t i o n s t a k i n g u t m o s t c a r e t o a v o i d contamination of medicines

55

Th e following pest control measures c a n be ta ke n f r om tim e to tim e -bullbullRat bait and traps can be placed at various locations bullbullInsecticutors can be used on a permanent basis bullbullInsecticidal sprays and repellants can be used from time to time

i i i ) Fire precautions

Combustible trash such as cartons boxes and other packing waste must not be allowed to accumulate in the store Waste should be deposited in appropriate waste bins and be d i s p o s e d o f f o n a d a i l y b a s i s

F i re detection and fire fighting equipment must be maintained and regularly inspected The pharmacy personnel should receive adequate training in fire fighting techniques and emergency actionFire prevention measures should include a prominently displayed ldquoNoSmokingrdquo sign careful handling and disposal of combustible waste materials and checking of electrical connections at regular intervals

iv) Security middot Doors shutters of the pharmacy should be strong and be fitted with secure locks middot Counters should be designed so that unauthorized personnelclients do not have

access to areas where prescription medicines are stored Access to such areas should be restricted to the pharmacy staff

middot All the pharmacy staff handling supplies should be accountable for their ac t i o n s

56

middot bullSpecial care must be taken in case of Schedule X and manufactured drugs (under NDPS Act) Such medicines should be kept under lock and key and the key should be kept with the Chief Pharmacist or i n h i s a b s e n c e t h e s e n i o r p h a r m a c i s t

v) Breakagespillage and damaged product Products that have been damagedspoiled during storage and handling spillages and broken glassware should be disposed off according to procedures laid down by the pharmacy Broken and damaged products s h o u l d b e p l a c e d i n a segregated area to be returned to the supplier

vi) Inspection Senior staff should inspect all pharmacy areas regularly The shelves and drawers should b e c h e c k e d d a i l y f o r signs of pests and dust Ceiling and walls should be checked for dirt and cobwebs Stock should be checked on a regular basis for deterioration due to climatic conditions

43 Product recalls Products found to be defective should be quickly recalled (withdrawn from the market) The instructions are generally issued either by the manufacturer or the regulatory agency The level of recall is determined by both the degree of risk and the extent of distribution of the product and in India is mainly directed at the distribution chain

On receiving the details of the defective substandard spurious batchbatches of a medicine to be recalled from the manufacturer or the stockist or the FDA the pharmacy should immediately check if the particular b a t c h i s i n s t o c k a n d i f s o s u s p e n d i t s s a l e immediately

Similarly if the regulatory authority in the country bans a particular medicine or FDC the pharmacy should immediately check and remove all the different brands of that particular medicine under consideration

The details of medicines and their batches to be recalled should be available in the q u a r a n t i n e a r e a w h e r e stocks are received and checked This is to ensure that such medicines do not come into the pharmacy

middot The pharmacy should develop SOPs for recall of medicines middot The pharmacy staff should be immediately informed about such medicines and

the details should be displayed in writing in a prominent place in the pharmacy middot Rapid action helps avoid unnecessary exposure to such medicines once the

problem has been d e t e c t e d middot The progress of the recall procedure in the pharmacy should be monitored every

few days to ensure complete compliance middot All stocks of the recalled products should be stored separately from the saleable

stock These can be stored in the expiry cupboard segregated from the expired goods and be appropriately labeled ldquoRecal l e d G o o d s - Not for Salerdquo

The supplier should be notified and asked to replace defective products middot All the details of the procedures followed should be duly recorded in a Recall

Register maintained specially for the purpose The register should include d etails such as -middot Date of the recall middot Nam e of the product

57

bullbull

middot Details of the product (name of manufacturer batch number expiry date) middot Nu m b er of units purchased sold a n d sto c k in ha nd middot Reason for recall middot Nam e of the supplier to whom produc ts w e r e returned along with the date and quantity middot Name and signature of the designated personnel carrying out the recall procedure and recording details middot Name and signature of the chief pharmacist verifying the recall procedures and recording details 4 4 Returned medicines

Medicines may be returned to the pharmacy by clients due to the following reasons -bull

bullbull Unused medicines bullbull Course not completed bullbull Therapy changed by doctor bullbull Side effects experienced by patient bull

bullbull DamagedDefective medicines bullbull Missing or defaced label bullbull Missing tablets in a stripblister bullbull Leakage in bottles bullbull Leakage in strips bull

bullbull Expired medicines

Appropriate SOPs should be framed and followed for their acceptancerefusal and disposal middot bull For unused medicines returned by clients the p harmacy personnel should verify

that these were purchased from their pharmacy They should then be checked for integrity of the packing the dosage form and the expiry date and verified with the client whether they were stored in appropriate conditions This again is at the discretion of each pharmacy

middot The damageddefective medicines returned to the pharmacy should be taken back and stored separately Existing stock of the same product should be checked for similar defects

middot Expired medicines should be accepted from clients at the discretion of the pharmacist and be immediately shifted to the expired goods cupboard These can be stored segregated from the pharmacys own expired goods and be appropriately labelled ldquoExpired Goods returned by clients- Not For Salerdquo

It is advisable not to accept returned medicines requiring cold chain storage (refrigeration) because it cannot be ensured that the cold chain was maintained when the medicines were in the hands of the patientclient middot Appropriate adjustments in t he stocks should be made for medicines

returnedexchanged to update the inventory middot The medicines should then be returned to the respective shelves middot A lsquoReturned Goodsrsquo register needs to be maintained to record all details of returned

medicines

R egister should include such details as-

58

middot N a m e o f t h e p a t i e n t middot Nam e of the product and quantity r e tu r n e d middot Product details such as the batch number and expiry date middot Condition in which received middot Reason for returning products middot Compensatory measures taken wi t h r e s p e c t t o c l i e n t middot Action taken with respect to product middot Name and signature of the personnel accepting the returned medicines and recording details middot Name and signature of the chief pharmacist verifying the recorded details

What the pharmacist would have learnt from this module The storage of medicines is a critical factor in the distribution cycle bullbull Stocks received by the pharmacy should be quarantined in a separate area and necessary checks s h o u ld be performed to ascertain the qua lity a nd quantity of stocks received bullbull Whatever pattern and means of storage used the products should be stored so as to maintain their potency and integrity bullbull Storage conditions should be monitored and maintained on a regular basis bullbull Optimum stock levels should be maintained and regularly monitored for expiry bullbull The design of storage areas should facilitate appropriate storage of medicines bullbull Cleanliness should be maintained in the pharmacy bullbull Adequate measures should be taken in case of returned medicines and recalled products

Optimum storage of medicines is mandatory whether at the distribution stage at the pharmacy or ultimately within the homes of patients The pharmacist has an important r o l e t o p l a y i n t h e s t o r a g e o f m e d i c i n e s i n m a i n t a i n i n g d r u g p o t ency and efficacy and thus facilitating optimum therapeutic benefits Good Pharmacy Practice - IPA -CDSCO - WHO Appendix I Quality Assurance Templates of letters for use if found not of Standard Quality [Frozen and expired goods ]

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated To Name of the Supplier with address

Sub Not of Standard Quality GoMP-Supply of Drugs and medicines-(Codename) Return of Stocks to the Suppliers-reg(New drug policy 2009) Previous letterinvoice ref Sl No Drug Code Drug name

Manufacturing date Expiry date

Supplier address

B a t c h n o

The above items of PO nodated was drawn by the Drug Inspector (Place) on (______________date) as a statutory sampling and declared ldquoNot of Standard

59

Qualityrdquo on -(______________date) by the Government Analyst for the following reasons

- ldquoThe product sample do not confirm to IP specification for (Drug codename with respect to the content of drugrdquo

- ldquoThe product has already been blacklisted by TNMSC on -(______________date) for the failure of (quantity) of batches of drug codenamerdquo

As per the clause of the te nde r d oc um e nt ldquo I f the sa mple s d o not c onf o r m to statutory standardsthe tenderer will be liable for relevant action under the existing laws and the entire stock in such batch should be taken back by the tenderer within a period of 30 days o f t h e r e c e i p t o f t h e l e t t e r f r o m t h e v e n u e

The stock shall be taken back at the expenses of the tendererthe Procurement Authority have the right to destroy such Not of Standard Quality if the tenderer does not take back the goods within the stipulated time

The Procuring Authority will arrange to destroy the Not of Standard Quality drugs within 90 days after the expiry of 30 days mentioned above without further notice and shall also collect demurrage charges calculated at the rate of 2 per week on the value of the drugs rejected till such destructionrdquo

Hence we regret to inform you that you will have to take back the stocks available of the abovesaid batch at your own cost from the drug stores where you have supplied the above batch

Kindly acknowledge the receipt of this reference at once

P r o c u r e m e n t A u t h o r i t y Seal and Stamp

Copy to Ref No dated

1 ) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated13082010

To

Sub Frozen Drugs-ordered to return to the Suppliers-reg(New drug policy 2009) Previous letterinvoice ref

The following products which were earlier frozen have now been ordered to return to suppliers directly with permission from the State drug Authority In this regard the suppliers have been instructed to take back their failed batch from the drug store of the stores Hence you are now instructed to return the following failed batches to the suppliers by obtaining proper authorization letter and acknowledgements from them

60

Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

Kindly acknowledge the receipt of this reference at once

Procurement Authority Seal and Stamp

Copy to

Ref No dated 2) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated14092010

To

Sub Frozen Drugs-ordered to return to the Suppliers- for issue of gate pass after verification reg(New drug policy 2009) Previous letterinvoice ref

The following products which were earlier frozen have now been released Hence they may be issued Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

Kindly acknowledge the receipt of this reference at once

Procurement Authority Seal and Stamp

Copy to

61

Ref No dated 3) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated

To

Sub Stop instruction-reg(New drug policy 2009) Previous letterinvoice ref

Until further instructions stop issue all the batches of the following item Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

You must intimate the available stock in the stores of the said batch Number to the Procurement Authority immediately Also retrieve quantity if already issued

Procurement Authority Seal and Stamp

Copy to

Ref No dated 4) HOD Procurement Office of

62

Appendix II Material handling in drug stores

Rack approx rates and dimensions

S No

Item Description UOM Approx Rate

1 MEDIUM DUTY RACK SIZE 2900 H X 3090 W X 800 D IN MM (AS PER SPECIFICATION)

Each 2499800

2 MEDIUM DUTY RACK ADD ON UNIT FOR SIZE OF SR NO2

Each 2243100

To locate a Box no 3 Rack no 14 in row3

SAMPLE OF RACK no Bin numbering -------------- S a y R K 1 4 R o w 3 B o x 1 6

SAMPLE LAYOUT of RACKS in a Drug Stores

63

Sample of another warehouse of distribution warehouse system

64

65

Slotted Angle racks with bin cards

66

Plastic Pallets

Plastic pallets ar e l i g h t w e i g h t l o w- c ost and exceed industry standards for strength and durability

NOTE A pallet has bottom deckboards (see sketch) A skid does not have bottom

67

deckboards

Battery Operated Stacker

Electric Stacker Ehh (Manual Push Type) - Manual drive - Lifting electrically with Battery 12 V 88 Ah - For loading and un-loading of trucks - Battery and loading device built - in - Battery charge gauge and charging current gauge Simple and Easy Operation - Lifting and Lowering electrically direct on steering arm - Pulling and pushing through steering arm - Electrically operated relief valve on hydraulic aggregate Safe Operation - Emergency Off Switch - Constant lowering speed - Protection through lowering brake valve - Overload protection through overload brake valve - Load chains covered preventing pinching threat - Electrically interlocking during loading process - Secured battery compartment opens upwardly - Stable buffering of the steering arm in upright position - In accordance with EWG Guidelines 89 240 - In accordance with VBG 12b Prevention of Accidents

Pallet Truck [ Top ]

68

----------------------------------------------------------------------------------------------------------------------------

For Transport Of All Goods On Pallets Safe and Easy Operation - through single hand operation Lifting moving

lowering with steering handle - neutral position of the hydraulic possible - overload pressure relief valve Long Service Life - robust co n s t r u c t i o n

- special hardened axles - hardened chromium plated ram - maintenance free Easy Maneuverability - through rubber steering rollers - nylon fork rollers

A h a n d t r o l l e y

69

Trolley with plastic bins for several items del ivery

70

Digital Weighing balances

Balances amp Scales EF Seriers Precision Electronic Balance

71

1

Ice lined Refrigerators

600 litres refrigrator

72

Walk in cooler

vacuum cleaner

73

Directorate of Health Services

Satpura Bhawan

Madhya Pradesh

P R O C U R E M E N T ndash Government Order Relating to the Management of Stores

(Reproduced for reference material on basic procedure in decentralize d s y s t e m

followed by Health facilities in 1977)

Note This is for reference only as with New Drug Policy 2009 and systems going

changes all conditions may not hold good

MODULE I

4

FLOWCHARTS

middot EASY UNDERSTANDING OF THE PROCESS INITIATION O F T H E

PROCESS OF EMPOWERED PROCUREMENT WING-ldquoDRUG

C E L L-DIRECTORATE HEALTH SERVICESMADHYA PRADESHrdquo

middot UNDERSTANDING THE REQUIREMENT amp CHOOSING THE

CORRECT METHOD OF PROCUREMENT WITH APPROVAL OF

THE PURCHASE AND TECHNICAL COMMITTEE AS PER THE

DRUG POLICY

middot T HE TENDERING PROCESS

middot BRIEF OF THE PROCEDURE TO BE ADOPTED AFTER THE BIDS

ARE FINALISED

Flow Charts

P r o p o s e d S y s t e m I n i t i a t i o n

5

6

bull S y s t e m

7

bull System of Tendering at a Glance

8

DIRECTORATE OF HEALTH SERVICES MADH YA PRADESH

No Q E q p O c t 7 7 Bhopal the 2 6 th October 1977

(E x t r a c t e d f r o m t h e G O and reproduced f o r 2 0 1 0 -11 to have clearity on process of

procurement )

To

The Deans

The Divisional Joint Directors of Health

Th e J o int Director of Ayurveda

The Administrative officer ESISIndore

The Superintendents of Medical College Hospitals

The Superintendents of Special Hospitals

The Civil Surgeons

The District Family Welfare cum Health Officers

The Principals RHFWTC

MADHYA PRADESH

Subject -Rules Orders for management of stores

The Government of Madhya Pradesh in the department of Public Health and family Welfare have by their order No 305847795-2877MedIII dated the 13 th

October 1977 issued Rules for the management of STORES These come int o force from the day they are received by the officer-i n- charge of an institution

It is desired that these Rules be followed strictly both in lsquoletter and spiritrsquo and no explanations would be accepted for non-compliance

Sufficient number of printed cop ie s a r e be ing se n t to you f o r d istr ibution a m ongst your subordinate staff concerned with the subject

A C Gaur For Director Medical Services

Madhya Pradesh

9

ACQUISITION OF STORES

The word Stores used hereunder applies generally to all articles expendable as well as dead stock of the nature of plant machinery instruments furniture fixtures medicines linen etc etc

Any authority which is competent to incur contingent expenditure may sanction the purchase of stores required (sub ject to his d e le ga tion of f ina nc ia l pow e r s) pr o vide d the following rules are observed-

(a) A Purchase Committee comprising of atleast three Gazetted Officers is formed for approving quantity and quality of stores required

( b ) An enquiry for the articles purch ased should be sent out to various manufacturers and dealers if the total of the order is for Rs 15000 or less In case the purchase order is likely to exceed Rs 15000 ldquoopen tendersrdquo be called through news paper publicity ( f igur e s p e r ta in to 1 977)

(c) Stores s h o u l d n o t b e p u r c h a s e d i n s m a l l q u a n t i t i e s and often if such store is not perishable

( d ) Requirement of the whole year to be worked out a nd n o stor e sh ould b e p ur c h a se d in e x c e ss o f the requirement

(e) P u r c h a s e s h o u l d b e m a d e i n t h e m o s t e c o n o m i c a l manner but q ua lity ne e d not be sa c r if ic e d in the interest of the economy

(f) The details regarding the quality desired and expected purchase quantity should be mentioned in t h e e n q u i r y

(g) Purchase order should not be split up to avoid the ne c e ssity o f obta ining th e sa nc tio n o f t h e h i g h e r authority

( h ) The date and time of opening of the tender should also be published and in case the tenderers desire to be p r e se nt o n th e o c c a sio n th e y should b e a llo w e d t o d o s o

( i ) Mere initialing on the covers of the tenders is not sufficient All the Purchase committee members s h o u l d s i g n o n e a c h a n d e v e r y p a g e o f t e n d e r q u o t i n g t h e r a t e s A n y r a t e s w h i c h h a v e b e e n overwritten by the tenderer should not be c o n s i d e r e d u n l e s s t h e y b e a r t h e t e n d e r e r rsquo s s i g n a t u r e and subsequently signed by a member o f t h e Purchase committee

( j ) A list of tenders opened should be made out and t a l l i e d w i t h t h e o n e o f t h o s e r e c e i v e d i n t h e o f f i c e Such a list should be signed by all the members of the Purchase committee

( k ) A comparative statement is then made and lowest t e n d er i s a c c e p t e d s u b j e c t t o q u a l i t y o f f e r e d b e i n g

10

satisfactory Samples of non perishable articles should be preserved safely under lock and key for comparison till the contract for supply is in force

( l ) R e a s o n s for rejecting the lowest tender and accepting the h i g h e r o n e s h o u l d a l w a y s b e r e c o r d e d in writing by the Purchase Committee

(m) No reason for rejecting the lowest tender need to be communicated to the tenderer

( n ) Every purchase order should clearly mention that the articles ordered shall be accepted subject to t h e approval of the Purchase Committee

( o ) Rules regarding deposition of earnest money and security money should be observed

( p ) For emergent purchases in public interest when there is no time to observe Store Purchase Rules purchases should be made up to Rs 2 5000 (refers to year -1 9 7 7 ) a t a t i m e A s f a r a s p o s s i b l e t h i s practice should be avoided

II PLACING OF ORDERS (a) For medicines and such other articles which the Medical Stores Depot Bombay

supplies order be placed with them at a specified time ( b ) For articles not on the Bombay Stores Depot Bombay lsquolimitedrsquo or lsquoopenrsquo

tenders be invited as the case may require It would be preferable to place orders on the manufactures or their authorized distributors

(c) For placing the orders on PSUrsquos Laghu Udyog Nigam or Organisations approved by the State government no tender needs to be invited

( d ) Price preference upto 10 is available to Small Scale Industries of this State only(not applicable as per New drug policy 2010 -1 1 )

III RECEIPT OF STORES All materials received should be examined counted measured or weighed as the

case may be when the delivery is taken The stores thus verified be may be immediately entered in the stock register Book under proper headings and this fact should be recorded on the body of the bill mentioning the page number of the Stock Book It should also be mentioned whether the quality and the quantity are correct as per the requirement Soon after the receipt each item be stamped with the initials of the institution

IV CUSTODY

(a)The head of the institution should ensure suitable accommodation for keeping the stores with a view to prevent losses through theft accident fraud or otherwise

(b) Separate Stock Accounts should be kept of-( i ) D e a d S t o c k-such as plantmachineryfurniture equipmentinstruments

etc (ii) Expendible items such as medicineslinenrubber goods etc (iii) Perishable articles

(c ) all recepts and issues in the stores stock registers should be on the authorityand under the signature of a respon sible officer deputed for the purpose

11

V ISSUE OF STORES (a) When materials are issued from stock the officer -i n ndashcharge should ensure that the indent is in proper proforma (Annexure A) and the person taking delivery is an authorized one (b) The issue vouchers (Annexure B) for articles should be prepared in triplicate by one single stroke of pen The first copy will remain with the records of the stores The second and third copies will go to supplies The second copy will be retained by the person receiving the supplies and the third copy will be returned by the receiver to the stores after making entries of hisher stock book page number etc against each item ( C ) E v e r y t i m e i s s u e b e r e c o r d e d i n t h e s t o c k b o o k o f t h e s t o r e s w i t h s i g n a t u r e s o f t h e O f f i ce r i n -charge

(d) Every issue made from the Central Stores to other institution should show cost of article preparation of Annual Stores Account at a later date

VI Maintenance of Stock Books (a) Stock book should be kept under the charge of a responsible person and should be

saved from loss and destruction ( b ) While making new entries in the main Stores Stock book cost of each item

should be entered though this need not be done in the case of registers in Wards Operation Theatre Out door etc

(c) There should b e n o o v e r-writing or interpolation or smudging of figures Any f i g u r e i f i t i s t o b e c o r r e c t e d s h o u l d b e c l e a n l y c u t a c r o s s a n d t h e n e w f i g u r e should be written by its side or below it under proper attestation

( d ) Stock books should always have a page count(each page be numbered) A certificate showing the number of pages be given on the first and the last page under the signatures of a Gazetted Officer

(e) Receipts issues and balances should be worked out for every item and attested regularly by the Offic er-i n -Charge of the Stores

(f) In the receipt column details regarding the size quality and any special features if t h e r e b e s h o u l d b e r e c o r d e d e g i n t h e c a s e o f A l m i r a h i t s s i z e a n d w h e t h e r i t i s of Steel or Wood

(g) In the Stock-book of library Edition and the ye a r o f p ublic a tion of th e book should always be mentioned

( h ) In case of medicines having an expiry date a list of such medicines be made out and should be checked every week Two months prior to the date of expiry if the s t o c k i s s t i l l f o u n d s u f f i c iently high intimation should be given to Directorate of Health

(i) N o r e m o v a l o f d e a d s t o c k s h o u l d b e m a d e f r o m t h e s t o c k ndash B o o k u n l e s s s o a u t h o r i z e d b y t h e c o m p e t e n t A u t h o r i t y

(j) While making a new Stock book and transferring the stocks therein it should ensured that the page number of the old stock book is shown in the new stock b o o k a n d s i m i l a r l y p a g e n u m b e r o f t h e n e w s t o c k b o o k i s m e n t i o n e d i n t h e o l d one This has to be done to facilitate cross checking whenever desired

( k ) T h e r e h a v e t o b e d i f f e r e n t s e t s o f proforma for dead stocks and for expendable items

Annexure ldquoCrdquo is for former and Annexure ldquoDrdquo for the latter varieties

12

VII PROCEDURE OF INDENTING FOR WARD amp OTHER SECTIONS OF THE INSTITUTION

(a) There has to be an Indent Book with every such section wh ich receives and issues medicinesequipment

( b ) The indent shall be prepared by the nurse Compounded -i n -c ha r g e of th e WardSection in te single copy on the Performa (Annexure A)

(c) The indent so prepared will be signed by the medical officer resident ndash i n c h arge or in his absence by a doctor senior to him but associated with the ward section

( d ) The indent shall then be signed by the head of the institution (Superintendent or the Civil Surgeon as the c a se ma y be ) o r b y his A ssista n t if th e la tte r is so authorized in writing

(e) The indent book is then presented to the main Store for effecting issue (f) The Store will then prepare issue vouchers (Annex B) in triplicate as directed

in Paragraph V (b) supra The supplies and the Indent Book are taken back by the Ward Section- i n - charge after signing the first copy of the issue voucher

(g) Te supplies after arriving in the WardSection shall be entered on the WardSection stock register which is prepared on a proforma (Annexure E) and page number of each entry be shown o n t h e 2 n d a n d 3r d copies of the Issue

voucher The 2 n d copy of the voucher is to be retained in a file in the wardsection but the 3r d c o p y s h o u l d b e r e t u r n e d t o t h e s t o r e b e f o r e s u b m i t t i n g a fresh indent The Store has to be maintain separate files of the 3 r d copies Wardsection-wise

VIIIHOW OFTEN TO INDENT

(a) A wardsection ndash i n -charge should work out an average weekly expenditure of each item and efforts be made to replenish the WardSection stocks every week

( b ) T h e M a i n s t o r e i n o r d e r t o a v o i d h e a v y rush of work should fix a day of issue for each major specialty T w o or th r e e minor spe c ia ltie s c a n be gr o upe d f o r one day

IX EMERGENT INDENT It is very likely for unforeseen reasons either the weekly indent of WardSection stock might get exhausted earlier or something which was not there in the lsquoweekly indentrsquo is required Under such circumstances an ldquoEmergent Indentrdquo could be made out in the usual manner but under the signature of the Unit-i n- chargeconsultant and it must be countersigned by the head of the institution (and not by his assistant) These supplies have also to be entered in the wardSection stock books like others

13

X HOW TO INDENT

(a) The ward Section -i n - c h a r g e s h o u l d e n s u r e t h a t t h e s t o c k s u n d e r t h e i r c h a r g e a r e not unnecessarily large and only a realistic quantity is indented once a week

( b ) The indent should not be made out in the names of the patients or by bed numbers The indent should be for the Wardsection as a whole

XI KEEPING OF RECORDS IN WARDS AND SECTIONS

(a) A set p r o f o r m a ( A n n e x u r e E ) s h o u l d b e u s e d i n t h e w a r d s e c t i o n f o r s h o w i n g u p receipts and issues Balance of expenditure for each item to be drawn out every morning by nursecompounder in charge before writing out the Indent or before restarting work The medica l O f f ic e r r e side nt in c ha r g e sh ould a tte st th e e ntr ie s after satisfying himself- by random checking at least once a week

( b ) To support the above mentioned expenditure the Bed head Tickets (treatment charts) are very important Each medicine prescribed should be legibly written indicating the total quantity prescribed if the medicine is to be deleted from treatment the fact should be mentioned as to how much of the drug was issued to the patient before switching on to another drug The suggestion is that a separate treatment card be maintained for each indoor patient ( Annexure ndash G) A summary s h o w i n g t h e t o t a l a m o u n t o f t h e p r o p r i e t a r y d r u g s c o n s u m e d b y t h e p a t i e n t d u r i n g is hospital stay be worked out and noted in the summary card

XII ACCOUNT ABILITY OF DRUGS BROUGHT BY THE PATIENT OR RECEIVED IN DONATION BY THE WARDSECTION _IN -C H A R G E

The drugs receoived from the non - governmental sources should be entered on the receipts side of the WardSection Sto c k b ook a n d issu e s to show n a s in th e o the r cases on the issues side

XII RSPONSIBILITY OF STORES AT VARIOUS LEVELS (a) The head of the institution shall be held responsible for non-observance of

rulesprocedures laid down by the Government ( b ) The Medical officerresident in charge of the stores and the store keeper shall be

held responsible for any irregularity found in the stores or for ignoring the ordered pattern of working It shall be the duty of the Medical officer Incharge of the Stores to occasionally check the WardSection Stock-b o o k s t o t a l l y t h e e n t r i e s made in the 3 r d copy of the Issue vouchers [as laid down under V (b)supra ]

(c) The Medical officerresident in charge of the WardSection shall be responsible for irregularities in indenting stocksfor maintaining stocks much in excess of the req uirement and for improper keeping of BED HEAD TICKETS (treatment chartsCards)

( d ) The NurseCompounder ndash i n -charge of the WardSection shall be responsible for shortages in stocks for putting up inflated indents and or for not taking into account medicines b rought by the patientson the WardSection stock-books Heshe shall also be held responsible for ensuring proper distribution of medicines to each and every patient under his her charge

XIV DISTRIBUTION OF MEDICINES FROM OUTDOOR DEPARTMENT (A) ( a ) T h e r e are proprietary and non -proprietary medicines (like mixtures ointments

and lotions) which are to be distributed gratis to patients 14

(b) The Outdoor incharge shall arrange to maintain a stock of common drugs (list of which shall be prepared by the Head of t he Institution) and arrange to replenish the stocks once a week as has been laid down for wards (c) No proprietary drugs shall be issued on the prescription of an intern ( d ) The Head of the institution shall make out a list of drugs which can be issued on

the prescription of a houseman from the Outdoor stock without the countersignature of any other authority

(e) The residents can prescribe any drug from Outdoor stock without the counter signature of any authority

(f) The Consultants can prescribe any drug to any ot h e r o u t e r p a t i e n t e v e n i f i t i s n o t s t o c k e d i n t h e o u t d o o r b u t t h i s s h a l l h a v e t o b e c o u n t e r s i g n e d b y t h e h e a d o f t h e institution for issue from The Main Store

(B) T h e p e r s o n i n c h a r g e o f t h e O u t d o o r m e d i c i n e s s t o c k s h a l l k e e p a r e c o r d o f t h e q u a n t i t y o f t he medicines issued to each patient and instead of writing the name and other details e may only put down the Registration number of the patient and the quantity issued

At the end of the day he must work out the total expenditure of eac item and draw it s balance

The Medical officer in charge of the Stores and the Head of the institution sould check these records at least once a week and affix is signature to confirm their inspection

(C ) No proprietary medicine shall be issued without a valid issue s l i p ( A n n e x u r e- F)

(a) For Housemen the slip would be of brown colour ( b ) For residentsDemonstrators it shall be of pink color (c) For consultants the issue slip should be white ( d ) All issue slips should be printed and pages serially numbered (e) T h e d o c t o r s t o w h o m s u c h i s s u e s l i p s w o u l d b e i s s u e d s h a l l b e h e l d

responsible for their sa f e ke e ping a n d th e y w ould e n su r e tha t th e se slip s would be printed and serially numbered

(f) The doctors prescription slips (for issue from hospitals) of proprietary drugs be prepared in du plicate with the help of carbon One copy should be given to patient for obtaining medicines from the Stores and the other would remain in the Doctors Prescription Slip book

(g) Every issue Slip should be signed and below the signatures a rubber s t a m p s h o w i ng name and designation be affixed The Store people would n o t h o n o u r s l i p u n l e s s t h e n a m e o f p r e s c r i b e r i s c l e a r a n d h i s a t t e s t e d signatures are available to stores

( h ) The Store Staff would file prescription slips of each doctor separately to facilitate the scrutiny at least once a month by the Head of the Institution Such a Scrutiny would reveal over prescribing of or injudicious use of drugs

(C) Proprietary medicines should not be issued for more than three days requirement at a time The only exceptions being cases for cancer pulmonary tuberculosis and leprosy In exceptional cases an officer not below the rank of a Consultant can prescribe for more than 3 days but after the countersignatures of the Head of the Institution

15

XV LOSS BREAKAGE DAMAGE ETC

(A) Any loss of public money departmental revenue of receipts stamps stores or other property held by or on behalf of the Government caused by defalcation or otherwise discovered in an office or institution should immediately be reported by the officer concerned to the head of department through his immediate superior as well as to the Accountant General if the loss exceeds Rs 20000(fig of 1977) (for Proforma see Annexure I)even when such loss has been made good by the party responsible for it Such reports must be submitted as soon as possible and soon after suspicion arises that there has been a loss they must not be delayed while detailed enquiries are made

When the matter has been fully investigated further and complete report should be submitted of the nature and extent of loss showing the errors or neglect rules by which such loss showing the errors or neglect of rules by which such loss was rendered possible and prospects of effecting such recovery

The s ubmission of such a repot does n o t d e b a r t h e l o c a l a u t h o r i t i e s t a k i n g f u r t h e r a c t i o n which may be deemed necessary like handing over the case to the police

Every Government servant should realize fully and clearly that he will be held personally responsible for any loss sustained by the government through fraud and negligence on is part and that will also be held personally responsible for any loss arising from fraud or negligence on the part of any other Government servant to extent to which it may be shown that he has contributed to loss by his own action or negligence

A s s o o n a s s h o r t a g e i n s t o c k o r l o s s i s d i s c o v e r e d a p a r t f r o m r e p o r t i n g t h e m a t t e r a responsible officer should be deputed to investigate the matter

W h e r e t h e r e i s n o l i k e l i h o o d o f a d e l i b e r a t e t h e f t b u t l o s s i s a result of neglect onlythe loss should be made good by the person on whose charge or custody the article lost remained

(B) As soon as damage or breakage of Government property is detected certain steps mentined under should be undertaken-

(a) A p r o m p t t h o ro u g h i n v e s t i g a t i o n i n t o t h e c a u s a t i o n o f b r e a k a g e o r d a m a g e s h o u l d be undertaken by the doctor-i n -charge of the WardSection or by the Head of the Institution

( b ) The investigating officer should draw conclusions as to whether the breakagedamage has been a result of-

(i) C a r e l e s s a n d n e g l i g e n t h a n d l i n g ( i i ) Unpredictable action of the patient for whom the equipment was

being used (iii) Accidental ( i v ) Manufacturing Defect

A report is then prepared in duplicate by person in charge of the article under question on the lsquobreakage and loss proformarsquo (See Annexure H)

16

These reports have to be signed by the investigating officer and are to be then submitted to competent authority for suitable action One copy which is returned is to be kept with the Stock Register In cases where the b r e a k a g e o r d a m a g e i s o f s u c h b i g g e r d e g r e e t h a t s atis factory repairs are not possible a n d if suc h b r e a k a ge o r da m a ge is o f su c h a de gr e e that satisfactory repairs are not possible and if such breakage or damage has been caused-

( i ) B y a G o v t s e r v a n t because of negligent or careless handling cost of the article should be recovered from him and credited to the treasury (ii)On account of reasons mentioned above that is un predictable action of the patient accidental or manufacturing defectthe article could be written offsubject to powers delegated to the concerned for such purpose

(C )Shortages detected during biannual physical verification of the Storeshave to be dealt in a similar manner

(D) it shall be at discretion of the competent authori ty (who is empowered to write off the loss) to reduce the amount of recovery upto 50 of the cost of article provided that before arriving at such a decisionhe has taken into account the following points (a) Normal life span of the article under questi on (b) Period for which it has been in use (c ) Condition of the article at the time of loss or damage and (d) Whether it was on account of careless or negligent act or not

XVI PROCEDURE FOR WRITING OFF STORES

(a) When any Stores become unserviceable otherwise than in ordinary course or by fair wear and tear their value should be treated as loss to the Government and in such cases cost should be recovered from the person responsible for his negligence

( b ) A s t r i c t w a t c h s h o u l d b e k e p t o n t h e m e d i c i n e s w h i ch bear an expiry date and if there is no likelihood of their being utilized locally intimation of the fact should be sent to Directorate of Health services and also to all o t h e r d i s t r i c t s s i m u l t a n e o u s l y s o t h a t t h e y c a n b e p u t t o u s e b e f o r e t h e expiry date In the event such a course is not followed and the Government i s p u t t o l o s s c o s t o f t h e m e d i c i n e i n q u e s t i o n s h a l l b e r e c o v e r e d f r o m t e defaulter

(c) For declaring articles as unserviceable a Committee of three members should be formed in each officeinstitution This Committee should examine each and every article brought before it and should record full reasons for condemning them and also say how the articles condemned have to be disposed of-whether by sale (by public auction) or otherwise

I f t he local Authority is not competent to write off the articles condemned by the Committee it should send the proposal to the higher authority for suitable a c t i o n

17

In Institutions where there is only one doctor a list of articles to be condemned should be p r e p a r e d a n d o r d e r s o n i t b e o b t a i n e d f r o m t h e inspecting authority during inspection

While preparing any list of articles for condemnation details regarding the date of purchase date of receipt period during which it remained in use usual life of the article and its purchase price should be noted against each item

( d ) The condemned articles should not be struck off the Stock Register till the competent authority sanctions its write ndashoff Details of Authority under which the article has been written off should be mentioned in stock register

XVII DISPOSAL OF WRITTEN OFF ARTICLES

Articles like linen should be torn into strips 10cm width so that they could be burnt or given to Government Jails for making carpets

Items like bed -pans bowlsurine po ts etc should be crushed and kept for auction

Brass utensils have also to be crushed to destroy their shape and could be either auctioned or after inviting rates from several dealers could be locally sold to highest bidder

In case when condemned ar ticles have to be sold by public auction they should be stored safely and the Government Auctioneer be intimated In case he expresses his inability to undertake the auction the officer should proceed with the auction departmentally The sale proceeds in either case should be credited to the Treasury as miscellaneous receipts under the Proper head of account

XVIII PHYSICAL VERIFICATION (a) The stocks held by officesinstitutions in various sections should be physically

verified twice a yearin the months o f April and October ( b ) Checking should be done by an officer other than te one who holds the charge of

Stores (c) Verification should be done in presence of officer holding the charge of Stores ( d ) All discrepancies found during the verification should be properly investigated

and accounted for

(j) Any excess detected during verification should be entered in the Stock book as Receipts with the remark ldquo Excess found on verificationrdquo

(ii)any shortage should be noted in issues column of lsquo Issuesrsquo described as lsquoshortage fou n d o n v e r i f i c a t i o n rsquo

XIX ANNUAL STORES ACCOUNT This account should be prepared according to the instruction issued from the department from time to time This should account for the outgoing financial year on the following lines -(a) Cost of the articles under various heads on the last day of the previous

year 18

( b ) Cost of the articles under the various Heads Received during the year (c) Cost of various articles written off during the year under review ( d ) Cost of the articles on the last day of the year or on the firs t d a y o f t h e

financial year following

19

Annexure A WardSection Indent Register No Issued on

Name of institution Page Folio No

Serial no Name of Article Quantity in Stock

Quantity required

Prepared by Approved by Recd by Note-Indenting Officer to sign and affix seal with name and

designation below the last item to avoid additions in one strokeno issues to be made by storesif Issue vouchers of

previous Indent has not been returned back by the WardSection

20

Annexure B Issue Voucher No (printed number)

Supplied to Wardsection Date

Indent no

Serial no Name of Article Quantity in Stock

Quantity required SB No

Stores-in MO Resident in Sign of charge charge WardSection

NurseCompounder Prepared by Recd Approved by by

Note-Indenting Officer to sign and affix seal with name and designation below the last item to avoid additions in one strokeno issues to be made by storesif Issue vouchers of previous Indent has not been

returned back 1st copy-Stores 2nd copy -Wardsection3rd copy-Tobe reurned to sores with Stock book entries

21

Annexure C

STOCK REGISTER FOR DEAD STOCKS

SERIAL NO DATE OF RECEIPT

Article with description

No of pieces Cost Details of

Bill Signature No Disposed

Date of disposal

Manner of Disposal

with Authority

Value realised Signature

1 2 3 4 5 6 7 8 9 10 11 12

P r e p a r e d B y C h e c k e d b y A p p r o v e d b y

Date Designation Name of Institution

22

Annexure D

STOCK REGISTER FOR EXPENDABLE ITEMS Name of article

Date

From where

received with cost

Quantity Signature To whom issued Quantity Balance Signature

1 2 3 4 5 6 7 8

23

Annexure E

Receipt amp Issue Register for WARDSSECTIONS (one or more pages as per requiremnt for each medicine)

NAME OF MEDICINE RECEIPT ISSUE

DATE Quantity In Stock

Date of

Issue

Issued toMention Bed no amp

quantity (in bracket) (For

Outdoor cases give Regd No)

Balance Signature

24

Annexure -F

OUTDOOR FREE MEDICINE SLIP In Duplicate

Name of Patient Registered No Date

Sr no Name of Medicine Quantity

Seal amp sign of doctor

25

Annexure-G

TREATMENT CARD

WARD NO

NAME OF PATIENT BED NO DATE amp TIME OF ADMISSION DATE amp TIME OF DISCHARGE

DATE MEDICINES PRESCRIBED SIGNATURE

26

ANNEXURE -H

PROFORMA FOR BREAKAGE amp LOSS

NAME OF OFFICEINSTITUTION DATE PLACE

SRNO NAME amp

DESCRIPTION OF ARTICLE

COST DATE OF PURCHASE

REASON CAUSE OF BREAKAGE

RECOMMENDATION OF INVESTIGATING AUTHORITY

Signature

Orders of the Competent Authority

Signature

27

Annexure ndash I Loss- Procedure for Reporting

1 The exact nature of the defalcation 2 The full extent of loss 3 The actual period covered by the defalcation 4 The defects in the negle c t o f r u le s by w hic h the loss was rendered possible

and circumstances which facilitated the defalcation 5 The names of the officials held personally or technically directly or

indirectly and wholly or partially responsible for the irregularity c o m m i t t e d i n t h e c a s e

6 Whether the c a s e a s b e e n J u d i c i a l l y t r i e d i n a c o u r t o r n o t i f s o c o p i e s ( i n duplicate) of the Judgment may please be furnished Copy of police report may also be furnished

7 The remedial measures adopted as safeguards against the losses hereafter 8 The prospects of re covery of the loss and he action taken to effect

recovery together with the amount recovered 9 Head of Account to which the Loss is debitable may be informed

Signature of Head of Office with seal

NoteA copy of this report is to be sent to AGMPThis is as per M P Finance Code Vol I

28

STORAGE AND STOCK MANAGEMENT

29

Foreword

The New Drug Policy 2009 is being implemented in the State of Madhya Pradesh

In order to have a proper procedure for Storage maintenance and expiry management of the drugs it is necessary to follow Good Storage Practices with Standard Modules for pharmacistStore keepers

Proper guidelines on Storage Practices can lead to better Stores and inventory upkeep with medicines being properly stored in racks with proper cleanliness and hygiene

This is a step towards storage maintenance and expiry management at the various stores in the state Looking forward to see that the heads of all health facilities take benefit from this module

D ir e c t o r M e d i c a l S e r v i c e s

30

INDEX

Sr No P a r t i c u l a r s P a g e

1 S T O R A G E A N D S T O C K M A N A G E M E N T 4

1 Quarantine and checking of stocks 11 Quarantine area 12 Checks to be carried out on new stocks

2 S t o r a g e 21 Need for proper storage 22 Different patterns of storage 23 Different means of storage 24 Temperatureclimatic conditions 25 Special storage of supplies 26 Storage and stability of medicines

3 Stock Control and Expiry Monitoring 31 Stock control 32 Stock rotation and expi r y m o n i t o r i n g

4 Other aspects of storage 41 Design of a storage area 42 Cleaning and maintenance 43 Product recalls 44 Returned goods

2 A p p e n d i x 1 Templates of letters for use if found not of Standard Quality [Frozen and expired goods ]

Frozen Drugs-ordered to return to the Suppliers-reg(New drug policy 2009)

Frozen Drugs-ordered to return to the Suppliers- for issue of gate pass after verification reg(New drug policy 2009) Stop instruction-reg(New drug policy

2009) Appendix II Material handling in drug stores

31

3 PROCUREMENT ndash Government Order Relating to

the Management of Stores

(Reproduced for reference material on basic

procedure in decentralized system followed by

Health facilities in 1977)

54

F L O W C H A R T S f o r a BI R D S E Y E V I E W o f

P R O C U R E M E N T

5 5

ACQUISITION OF STORES 6 1

PLACING OF ORDERS 6 2

RECEIPT OF STORES 6 2

CUSTODY 6 3

ISSUE OF STORES Maintenance of Stock Books

6 3

PROCEDURE OF INDENTING FOR WARD amp OTHER SECTIONS OF THE INSTITUTION

6 4

HOW OFTEN TO INDENT 6 5

EMERGENT INDENT 6 5

HOW TO INDENT 6 5

KEEPING OF RECORDS IN WARDS A N D S E C T I O N S

6 6

ACCOUNTABILITY OF DRUGS BROUGHT BY THE PATIENT OR RECEIVED IN DON A T I O N BY T H E WARDSECTION _IN - CHARGE

6 7

RESPONSIBILITY OF STORES AT VARIOUS LEVELS

6 7

DISTRIBUTION OF MEDICINES FROM OUTDOOR DEPARTMENT

6 7

LOSS BREAKAGE DAMAGE ETC 6 8

PROCEDURE FOR WRITING OFF STORES 6 9

DISPOSAL OF WRITTEN OFF ARTICLES 7 1

FORMATS TO BE USED 7 3 - 81

32

STORAGE AND STOCK MANAGEMENT The expiry periods of pharmaceutical products have meaning only if the products are stored under proper conditions otherwise products are likely to lose their potency before the actual date of expiry

A pharmacist is a vital link in the distribution chain for pharmaceutical products The medicinal products remain for a long period during the distribution cycle at the wholesaler and at retail pharmacies It is therefore very important to maintain proper storage conditions in these units

Every community pharmacy however large or s mall needs to store and manage its medicine stocks effectively There must be systems to ensure

middot bullbull Secure storage middot bullbull Clean and correct environmental conditions during storage middot bullbull Accurate and effective record keeping middot bullbull Effective stock rotation and expiry monitoring middot bullbull Effective fire and theft prevention middot bullbull Effective rodent pest control

For easier un derstanding this module has been divided into the following sections

1 Quarantine and checking of stocks 11 Quarantine area 12 Checks to be carried out on new stocks

2 S t o r a g e 21 Need for proper storage 22 Different patterns of storage 23 Different means of storage 24 Temperatureclimatic conditions 25 Special storage of supplies 26 Storage and stability of medicines

3 Stock Control and Expiry Monitoring 31 Stock control 3 2 S t o c k r o t a t i o n a n d e x p i r y m o n i t o r i n g

4 Other aspects of s t o r a g e 41 Design of a storage area 42 Cleaning and maintenance 43 Product recalls 44 Returned goods

33

1 QUARANTINE AND CHECKING OF STOCKS

11 Quarantine Area D r u g S t o r e pharmacies receive stoc k s f r o m su pplie r s a c c or d ing to pur c h a se o r d e r s T he stock that is received must be visually checked for quality and quantity The stocks must be kept in a separate area until the checking is done to avoid intermixing with existing stock This necessitates the presence of a separate area within the pharmacy w h e r e i n t h e storage and other checking of stocks can be performed This area is called the QUARANTINE AREA This area should be marked and identified adequately to distinguish it from other areas

The area may be marked using different means 1 ) A s m a l l board saying Quarantine on a separate table used exclusively if it is in the middle 2) A board on the wall if the table on which the quarantine stock is placed is against the wall

middot Stock received from wholesalers should be immediately transferred t o t h e Quarantine Area

middot In the Quarantine area the stock may be stored on racks shelves or in cupboards to prevent ingress of moisture dirt and other contaminants

middot Regular stocks from the pharmacy should not be left kept in the quarantine area Special care has to be taken in case of refrigerated medicines supplied by the suppliers so tha t the y do not remain in the quarantine area for long periods of time They should be immediately checked on receipt and transferred to areas for refrigerated storage s o a s to maintain the cold chain bull

Advantages of having a separate Quarantine Area middot Avoids cross mixing of newly arrived stock from existing stock till it is checked middot Lays stress on checking the quality of the stock received middot S to ck checking ensures t hat defective andor expired goods do not enter the storage areas

34

bullbull

bullbull

12 Checks to be carried out on new stock

Unpacking and checking stock

Supplies received should be unpacked and checked in the quarantine area Staff doing the checks should be adequatel y trained in what they have to check when stock arrives

Checking should be seen not simply as counting the units received but as a part of the quality assurance system bullThis should include middot Visually inspecting the packaging middot Checking the integrity of containers middot V erifying the completeness and leg ibility of la b e ls ( a ppr o ve d dr u g name strength any special storage instructions and expiry date)

bull

The expiry dat e should be checked to ensure that there is adequate shelf life remaining

Supplies should be individually checked using a checklist 35

Checklists

36

The wholesaler supplying the product should be notified immediately in case of any discrepancies ( and the details should be recorded in a register) and sent in a written format to the supplier It should include middot Missing boxes or cartons middot O p en tampered boxes or cartons middot Missing supplies middot Differences in the actual quantity and the quantity shown on the packing middot Additional medicines that had not been ordered but have been supplied middot D a m a g e d b r o k e n o r p oor quality medicines middot Any other discrepancies

The purchase invoices are an important aspect to be considered The invoiced documents should be signed and filed for reference as per the Drugs and Cosmetics Act and retained for at least 3years

If the wholesaler supplies medicines as an emergency without a bill or against a delivery challan

middot The supplies should be checked for integrity and inspected for damage middot The details of supplies received should be recorded middot The supplier should be asked t o send the bill as early as possible middot When the bill is received it should be checked against the details recorded and anomalies if any should be reported to the supplier

To keep a track of the received stock maintaining a S t o c k R e c o r d C a r d c a n b e very useful The entries in the stock record card can be made while checking the stock received STOCK BIN in the stores should have Stock record card

Maintaining a stock card for every product may not be very practical for a retail pharmacy however it could be maintained for costly medicines Nowadays it is much more practical and easier to maintain records using computers

The pharmacist should ensure that medicines manufacturedmarketed by a company are received only through an authorized distribution network of that company This is important to prevent spurious and counterfeit drugs from entering the pharmacy

37

2 STORAGE 21 The need for proper storage The storage of medicines and other products is an important requirement of Good Pharmacy Pr actice Appropriate storage of medicines is essential -

middot bullTo ensure that the potency is maintained middot bullTo prevent deteriorationspoilagedegradation middot bullTo ensuremaintain physical integrity

To ascertain that the quality and safety is maintained throughout their shelf life Storage requirements need to be considered on 2 aspects

a) Integrity of medicines Medicines should be stored in such a way so as to maintain their integrity and potency middot Maintain the right temperature required middot Protect from excessive humidity middot Keep medicines away from direct sunlight middot Protect from pests and rodents

b) Physical location middot Should be easy to locate middot Accessible middot Orderlysystematically placed

2 2 D i f f e r e n t p a t t e r n s o f s t o r a g e The pharmacist could follow any of the different patterns of storage The pattern of stora ge should be selected in such a way that it facilitates speedy and efficient dispensing of medicines

The pattern of storage could vary with each pharmacy experience usual practiceroutine of staff and the person-in charge and also depending on space av ailable turnover etc (i) The medicines could be stored c o m p a n y w i s e ie the medicines manufactured by one company should be grouped together and kept in one place Within each company shelfshelves the medicines may be placed in alphabetical order for easy and quick placement and removal Also bottles tubes boxes etc may be segregated within that shelf

38

(ii) The medicines may also be stored in a lphabe t ic al o r de r ie they are placed in order from left to right based on their name The first letter of the name is used to g r o u p t h e m e d i c i n e s t o g e t h e r a n d k e e p t h e m i n o n e l o c a t i o n I n s o m e p h a r m a c i e s a l l t h e strip packing are placed in drawers or boxes in alphabetical order each box or drawer containing strips of one particular alphabet This system ensures that the strips always remain e n c l o s e d i n t h e b o x e s d r a w e r s a n d a r e n o t e x p o s e d t o d u s t T h e d i s a d v a n t a g e i s that it might lead to mix -u p o f strips in the same drawer and it may cause a problem incase of similar looking strips in which case a wrong medicine may be dispensed Secondly cut strips lying around in the drawer may lose their identity if the batch n u m b e r andor expiry date is not seen on the cut portion of the strip

39

(iii) The medicines may be stored according to their therapeutic class ( e g a n t i b i o t i c s anti asthmatics or anti hypertensives) ie the medicines are kept together based on their pharmacological or therapeutic action

(iv) The medicines may be stockedsegregated according to dosage forms eg l i q u i d s (bottles) solid oral dosage forms eye drops rotacaps ointments etc all stored on separate shelves

Always Remember I Storage of prescription medicines should preferably be separate from OTC medicines OTC medicines especially those that a r e a d v e r t i s e d m a y b e d i s p l a y e d f o r c l i e n t s t o select or to ask questions about [OTC-O v e r t h e c o u n t e r ] II Storage according to temperatures is a must no matter which pattern of storage is followed Also within a particular storage area segregated storage may be maintained In a refrigerator for example medicines may be stored in trays racks and the freezer according to the temperature required

40

Whatever pattern of storage is selected all the personnel should ensure that middot The stocks are stored in an orderly manner middot The medicines are kept back in the same place from where they were removed middot All medicines are arranged neatly once in a while

middot The personnel should be careful while storing the medicines middot They should not throw the medicines haphazardly 23 Different means of storage

middot Within each temperature and security zone medicines must be stored so that they are easily accessible and protected against damage

middot Basic means of storage include shelves racks and drawers middot To prevent dust from entering the shelvesracks it is ideal to have glass

shutterssliding glass doors This can however be disadvantageous because accessibilityspeed is hampered in removing a product from the shelf because the glassshuttersliding glass has to be

41

opened m o v e d e v e r y t i m e a p r o d u c t h a s t o b e p i c k e d u p U s e o f a i r c o n d i t i o n e r s f o r t h e p h arm acy with a closed door at the e n t r a n c e o r a n a i r c u r t a i n c a n r e d u c e t h e d u s t problem In such cases the shelvesracks may be left o p e n

bull

middot Direct storage of cartons on the floor should be avoided because besides being an unhealthy practice the contents may also be damaged by moisture bull

middot Store medicines preferably in shelves with glass shutters for visibility middot Closed shelves further prevent dust from going in especially in India where most

pharmacies are located along busy roads middot Some medicines have to be refrigerated or stored in a cool or cold place Having a

refrigerator or two (as per the need of the pharmacy) is essential to store suc h medicines at temperatures mentioned on the label bull

42

Refrigeration middot All cold chain equipment should meet required standards middot Improvement in refrigeration technology has provided frost -free refrigerators

Pharmacists should opt for frost-free refrigerators as they are easy to maintain and protect printed packaging materials Conventional refrigerators may cause water falling from trays below the freezer on medicines stored in the refrigerator thus causing soggy labels

middot bull Frost-free refrigerators also provide separate and large compartments for the freezer portion (required for storing medicines needing sub-z e r o t e m p e r a t u r e ) and the main storage area with separate doors so that opening one door does not disturb the storage temperature in the other compartment

Care should be taken to keep the refrigerator on 24 hours a day It should not be switched off after working hours It is advisable to have an inverter connected to the refrigerator so that the refrigerator re mains working even when there is a power outage

middot The refrigerator door should be closed tightly middot The refrigerator door should not be left open for too long middot Space should be left between medicines stored in a refrigerator to allow air to

circulate middot The ref rigerator should be placed about an arms length away from the wall

This will increase air circulation thus not affecting the cooling within the refrigerator

middot Vaccines should not be stored on refrigerator door shelves as they are exposed to warmer temperatures each time the door is opened Vaccines should always be stored on the middle shelves of the refrigerator

middot Refrigerated medicines should not be left out of the refrigerator for more than a few minutes

43

middot Consumable products like juices energy drinks e t c s h o u l d n o t b e s t o r e d a l o n g with medicines in refrigerators If required they may be kept in a separate refrigerator

middot An adequate number of refrigerators should be planned to store the entire stocks requiring refrigerated storage

middot Adequate procedures should be followed for defrosting cleaning and maintenance of refrigerators

middot Icefreeze packs should be kept in the freezer compartment so that they can be used for transporting cold temperature medicines The packs can be given to clients along with the medicines requiring cold temperature storage so that the temperature is maintained till the client reaches home and can then put the medicines in a refrigerator) Freezer packs can also be used to keep medicines temporarily in case there is a power outage or refrigerator breakdown

Activity

Prepare a SOP (Standard operating procedure chart) for cleaning a refrigerator Discuss it with your staff finalize its maintenance once a month through AMC -A n n u a l Maintenance contract CMC - Comprehensive maintenance contract and put it up on the pharmacy refrigerator Put the Purchase Order details name of manufacturer Phone of Service Engineer and a register to login the Machine service and down timeService reports may be maintained properly

Refrigerator monitoring and maintenance

middot bullIt is important to carry out routine monitoring and maintenance of the refrigerators and to organize an effective repair system

middot bullThe temperature in the refrigerator must be monitored and recorded routinely at least once a day

middot Any breakdown must be reco rded including the period during which the medicines were exposed to uncontrolled temperatures Medicines may then be kept or discarded depending on the problem guidelines or the manufacturers advice

middot Cold chain monitor cards and devices in or on packages that change color or otherwise alert staff to potential damage assist in monitoring (These are likely to be introduced in India soon)

middot It is essential to have a contingency plan in place before a refrigerator breaks down An arrangement can be made to move the contents to a private refrigerator elsewhere in the community or to obtain a regular supply of ice packs until the defect is rectified

Put filled water bottles in the bottom half of the refrigerator door in order to provide cooling in the refri g e r a t o r w h e n t h e r e i s a p o w e r o u t a g e T h i s m i g h t t a k e c a r e o f t h e temperature when there is no current for a couple of hours If the power outage is expected to last for several hours special arrangements such as an inverter UPS have to be made to keep the refrigerator constantly running in the absence of electricity middot Defrost the refrigerator in case of excessive ice formation and preferably at regular

intervals Keep a record of the same

44

2 4 T e m p e r a t u r e c l i m a t i c c o n d i t i o n s

i) Temperature control middot The medicines in a pharmacy need to be stored at appropriate temperatures to

maintain their stability middot An air-conditioned environment where temperature can be controlled is

recommended for pharmacies Air conditioning offers the option of setting the t e m p e rature as per requirements

middot bullIt is ideal to have an air conditioner to maintain the temperature below 25 C as most medicines require storage below this temperature Secondly this temperature is pleasing to both the staff and the visiting customers too

middot In the absence of an air conditioner circulating fans may be used middot This need is felt even more in certain parts of India where temperatures soar above 45

C and some areas where it falls to sub zero temperatures In such cases temperature maintenance is essential to prevent deterioration of medicines due to unnecessary exposure to drastic temperature fluctuations

middot This need is felt even more in certain parts of India where temperatures soar above 45 C and some areas where it falls to sub zero temperat u r e s I n s u c h c a s e s temperature maintenance is essential to prevent deterioration of medicines due to unnecessary exposure to drastic temperature fluctuations

i i ) Humidity or moisture control Moisture or humidity can adversely affect the stability of me dicines such as tablets capsules powders

45

Gelatin capsules become soft and swell on absorption of moisture The drug content of tablets may undergo surface hydrolysis The presence of moisture may encourage the growth of microbes It is therefore essential to control humidity

To reduce the effect of humidity the following suggestions may be followed -middot Open the windows to allow air circulation Use a fan to circulate fresh (outside) air middot In humid climate a dehumidifier is useful for preventing mo i s t u r e d a m a g e ( i n t h e absence of an air conditioner) middot For bulk containers of tabletscapsules do not keep the container open for a long time and replace the lid or closure immediately after taking out the required number of medicines for dispensing middot Do not allow the medicines to touch the floor or the walls The walls may be damp and may cause moisture absorption damaging the product

middot Calibrated thermometers and manometers can be used to detect temperature and humidity in the pharmacy

middot Periodici t y of checking the temperature should be fixed middot The climatic conditions should be recorded and documented middot Temperature charts should be available for ready reference

Documentation is one of the core activities for achieving and maintaining quality It is one of the most essential components of validation Temperatures in various areas

46

including refrigerators should be recorded at a predetermined periodicity usually daily at the hottest time of the day and such documents should be preserved i i i ) Storage conditions A number of storage conditions are mentioned on the labels of medicinal products These conditions have to be properly interpreted and appropriately complied with

According to the Drugs and Cosmetics Rules 1945

1 The term cool place means a place having a temperature between 10 C and 25 C

2 The term cold place means a place having a temperature not exceeding 8 C In case of storage conditions for specific products please refer to Schedule P The Drugs and Cosmetic Rules 1 9 4 5

The Indian Pharmacopoeia specifies the following storage conditions -

Wherever the condition for storage is not specified medicines may be stored under normal temperature In a country like India however where normal temperatures soar to h i gh temperatures it is recommended that medicines be stored in a cool place

Activity Prepare a list of the storage requirements mentioned on the label of about 20 products in your pharmacy and check if the temperature is maintained

47

25 Special Storage o f s u p p l i e s If the product has no special instructions normal storage conditions apply This means storage in dry clean w e l l -ventilated premises at temperatures of +15 C to +25 C or depending on the climate up to +30 C (WHO1990) Storage instructions are product specific Different brands of the same generic drug may have different storage requirements as they may have different packaging or formulations It is essential to follow the product manufacturers storage instructions to the maximum extent possible Less stable medicines must be stored in specific conditions to maintain their quality or potency

The following products require special storage facilities

middot Products that must be kept frozen (usually vaccines and sera) middot Products sensitive to h eat an d r e q uir in g r e f r ig e r a tio n ( +2 C to +8 C) middot Products that have reduced shelf life at uncontrolled room temperature and need

mechanical ventilation or air conditioning middot Flammable products that require separate fireproof premises middot Products prone to theft o r m i s u s e

Products needing storage in a controlled environment -

The usable shelf life of the following products may be reduced if stored at uncontrolled humidity or at room temperature in hot climates -

middot Some injectables (eg adrenaline) Most injectable preparations are less stable than solid oral forms (tablets and capsules) Injectable preparations in solution are particularly unstable Many injections must be protected from light as well as heat

middot Intravenous fluids (particularly if packed in p lastic containers) middot Some suppositories pessaries creams and ointments These products may melt at

temperatures greater than 30 C Once this happens it is not advisable to use them because the active ingredient in the formula may get unevenly distributed

middot Products containing rubber latex cellulose or some plastics Condoms most sterile disposable medical devices and surgical products such as syringes needles and catheters require protection from excessive humidity and strong light and heat Any o f these conditions may make products brittle stained amp unusable Sterility cannot be assumed if packaging is damaged

In hot climates these products should be stored in the coolest place possible preferably with air conditioning or air circulation fans

48

Products needing freezing or refrigeration-middot Vaccines blood products and many other medicines lose potency if kept even for a

brief period at temperatures outside the recommended range For these products the cold chain must be maintained at every stage of the distribution system

middot Freezing is as damaging as high temperatures for some products including injectable contraceptives ergometrine insulin adrenaline and the DPT DT TT and Hepatitis B vaccines Such products therefore sho uld not be allowed to freeze (not be kept in the freezer compartment)

middot Short periods at room temperature (during transportation or local distribution for instance) may be acceptable for many products (such as ergometrine a n d i n s u l i n ) e v e n t h o u g h s u c h e x posure can to some extent reduce shelf life Other items such as vaccines should always be transported in cold boxes

Storage of insulin injections-

middot Insulin should always be stored in a refrigerator at the recommended temperature of 2 -8 C

middot Insulin should not be kept in the freezer compartment of the refrigerator middot Insulin should ideally be stored horizontally middot It should not be exposed to sunlight or excessive heat middot Insulin suspensions should not be used if the suspension cannot be properly

resuspended due to cake or clump formationbull

Controlled drugs -Narcotics (for example Pethidine injection morphine preparations) and other specified drugs that may be abused are governed by special legislation and regulations The following security measures are suggested in the pharmacy -middot A safe or reinforced double locked cabinet fitted with a light (preferably with a red

bulb) that comes on when the door is opened

49

middot A special register recording details of each receipt or issue with 2 signatures physi cal counting of medicines after each entry and signatures at handover takeover

middot Independent audit (by supervisors and drug inspectors)

Products prone to theft abuse or misuse -

Some medicinesproducts are particularly prone to theft abuse or misuse These include expensive medicines (eg insulin) certain antibiotics and products prone to abuse or misuse like psychotropics etc

Such medicinesproducts should be stored adequately They require stricter record keeping and more frequent stock taki ng than others Periodic audits should be carried out to check for consumption against actual recorded use (registers prescription records stock records etc) to expose any theft or misuse bull26 Storage and stability of medicines Medicines are not stab le indefinitely They are stable for a specific period of time sometimes for a brief period Poor storage conditions accelerate the drug degradation (decomposition) Temperature light and moisture are the most important contributing factors for drug instability It is important to identify and be aware of the potential for instability There is a need to comply with storage requirements to ensure quality medicines for patients It is also important to offer advice to patients too about appropriate storage o f medicines at home The dispensing label should state the storage condition required and be backed up by a verbal reminder especially where special storage is required bull

50

In case stability and storage problems are seen with formulations they should be reported immediately to the representative of the manufacturer and taken out of circulation till the stability problems have been resolved

The pharmacist can easily detect stability problems when products show change in appearance color odor settling of the product contents breaking of emulsions melting of creams oozing of contents from the containers and any such physical changes

3 STOCK CONTROL AND EXPIRY MONITORING 3 1 S t o c k C o n t r o l For economic reasons pharmacists do not like to have stock on their shelves for long periods of time The aim should always be to keep stock at a level that will just meet demand Normally most manufactured medicines have a long shelf life Even then it is essential that there is efficient stock rot ation so that the older stock is used first It is also a good practice to check the expiry date as an integral part of the dispensing process When short shelf life products are involved stock levels may have to be modified to prevent medicines regularl y expiring on the shelves

32 Stock rotation and expiry monitoring In order to avoid accumulation of expired and obsolete stock medicines should be stored and issued according to the following guidelines -middot The stock control system must record the ex p i r y d a t e a n d t h e d a t e o f r e c e i p t middot Stock must be stored so that earliest expiring batches are picked and issued first middot The First In First Out (FIFO) system - In this system the stock which is received

first is sold first This system however may not be useful for pharmacies because most of the stocks carry an expiry date For pharmacies the FEFO system is more practical

51

middot The First Expiry First Out (FEFO) system - In this system the stock having an earlier expiry is sold first The stock with longer shelf life should be placed farthest to the back (or at the bottom in case o f sta c k e d b oxe s) T h is is pa r tic u la r ly impor ta n t with products that have short shelf lives such as vaccines some vitamins antibiotics etc and reduces losses due to expiry

middot E x p i r y dates should be noted on the stock record upon receipt Stock nearing expiry should not be accepted unless it can be used before expiry

Computerization and expiry monitoring In the pharmacy computerization facilitates both checking stocks and expiry mo nitoring and helps-bullbullKeeping a check on products nearing expiry bullbullKeeping a check on non- moving and slow moving products bullbullTo facilitate the removal of medicines nearing expiry from shelves in time to send them back to the wholesaler or supplier

Periodic checking for expiry The expiry date for medicinal products is a critical aspect in pharmaceutical dispensing and due importance should be given to it Periodic checking for expiry of medicines will ensure that the patient will never receive products that have crossed their expiry date During periodical checking of expiry the personnel involved should remove medicines that are nearing expiry bullbullIn -house threshold periods should be set and followed for retrieval of such medicines from the shelves bullbullSuch medicines should be stored separately These should either be dispensed immediately (thus ensuring that they are used before the expiry date) o r t h e y s h o u l d b e returned to the suppliers bullbullA separate area should be designated (cupboard or shelf)marked[FROZEN ZONE] which is adequately marked EXPIRED GOODS- NOT FOR SALE to store all expired stocks FROZEN ZONE

52

Remember Expired medicines are a NATIONAL WASTE So stock only what you can sell Avoid expiries save precious medicines for the nation

Treatment and disposing of expired medicines bullbullProcedures need to be in place for the treatment of expired medicines bullbullThe expired medicines need to be collected and be sent back to the supplier or company for appropriate disposal bullbullRecords must be maintained for expired medicines and how they are disposed off bullbullIn case of medicines that are not returnable to suppliers procedures for disposal need to be followed by the pharmacy in conjunction with the FDA The following procedure can be followed if medicines cannot be returned to suppliers ( T h e b a s i c p h i l o s o p h y of appropriate disposal is to prevent their re- circulation and use) bullbullC u t t h e c o n t ainer in such a manner that the label is also cut In case of tablets and c a p s u l e s d e s t r o y them by disposing them in a bucket of water bullbullUse landfill procedures (deep burial into the ground as per stipulations of Medical Waste Disposal Act prevalent in the respective state) bullbullPour the liquids into the sink and wash away with sufficient quantity of water bullbullKeep a record of such disposal with full details of medicines destroyed Although these measures are usually adopted care has to be taken with such tr e a t m e n t a s studies have shown that flushing of medicines has resulted in tracessmall quantities of medicines being found in waterways and groundwater having potential health and environmental effects

4 O T H E R A S P E C T S 41 Design of storage areas The following important factors need to be considered in design of storage areas -middot The retail outlets in hot areas in summers should be air-conditioned Similarly in

a r e a s o f e x t r e m e c o l d t h e p r e m i s e s w o u l d r e q u i r e w a r m i n g e s p e c i a l l y i n w i n t e r s t o maintain cool temperatures The placement of air -conditioners and heating devices should be such that medicines are not directly exposed to the cold or heat

middot Due consideration should be given to storage requirements of formulations while designing shelves and cupboards in retail outlets Sufficient shelf height should be provided so that all liquid products can be stored vertically As far as possible the shelves should be covered with glass panels to protect medicines from dust and p r e v e n t r a p i d f l u c t u a t i o n s i n temperature

middot Medicines should be stored according to the storage instructions on the labels bullIt is ideal to have a door at the pharmacy entrance to prevent dust from coming in as well as reduceprevent cooled air from going out This may not however be considered feasiblepracticable by many pharmacy owners for fear that clients may not enter the pharmacy because the door may act as a barrier An air curtain is a good alternative to a door

middot There should be minimal direct sunlight falling on the products Particular consideration should be given to premises directly facing the sun

middot bullThe arrangement of lighting in the interior of the premises should also be in a manner that the lights are not focused on the products It has been shown that light causes not only chemical damage but also can catalyze physical changes like moisture uptak e by the products Care should be taken to ensure that only diffused light falls on them

53

middot As far as possible provision should be made for a temperature and humidity indicator device in a pharmacy These devices are now easily available

middot Stability studies o f m e d i c i n e s p a c k e d i n b l i s t e r s h a v e r e v e a l e d t h a t i f t h e s e a r e exposed to light they tend to absorb moisture It is therefore necessary to store them in suitable cartons so that the blisters are not exposed to light Pharmacists should do this even if the manufacturer has not provided cartons

middot Light and temperature sensitive products should not be stored on counters where the light is intense or direct and there is no protection from temperature and humidity

42 Cleaning and maintenance i) Cleaning of storage areas

The storage areas of the pharmacy should be cleaned periodically and cleanliness should be maintained at all times The Standard Operating Procedure for cleaning should be designed and followed accordingly Schedules for cleanups should be laid down and adequate cleaning equipment should be made available

Tips for maintaining cleanliness middot Provide clean pieces of cloth for wiping at various locations in the pharmacy

Replace with clean cloth at regular intervals middot Keep separate pieces of cloth for floors shelves and medicines middot Use a disinfectant andor soap solution to clean floors middot Ensure removal of dust and prevent accumulation of dirt middot Ensure removal of cobwebs middot Use a vacuum cleaner for cleaning areas not easily reachable middot T a k e c a r e t h at breakages are handled and cleared effectively middot Observe the factors leading to waste generation in the pharmacy and take appropriate

measures to tackle the problem middot Record all cleaning procedures performed and maintain all the documents required

For ex a m p l e -bullbullThe floor of the pharmacy may be swept with a broom and swabbed with soap water every morning bullbullThe floor may be swabbed with a disinfectant every week bullbullThe entire premises including shelves and cupboards may be cleaned with a cloth (to remove dust and to check for medicines approaching expiry date or expired medicines) every three months bullbullAll the steps followed should be r e c o r d e d

The floor shelves drawers have to be cleaned and a check should be kept on dust cobwebs spillages due to breakage etc It is therefore essential to have SOPs for cleaning laying down cleaning frequencies allotting responsibilities and maintaining a daily record in the logbook to document all these activities

54

While cleaning dust settled on dosage forms like bottles tubes etc should be removed Before dispensing the products should also be wiped to remove any dust settled during storage

For refrigerators bullbullDefrosting and cleaning should be done at regular intervals bullbullSwitch off the refrigerator while cleaning bullbullCleaning should be done quickly and stocks put back immediately

i i ) Pest control Pests are a serious problem in India where insects reptiles and rodents (eg cockroaches l i z a r d s r a t s s i l v e r f i s h (Deemak - in Hindi ) etc) may find access to the pharmacy storage areas Insects like ants and borer ants may often attack wood in the pharmacy causing d am ag e to shelves cupboardsPest c ontr o l in a p h a r m a c y c a n b e a d i f f i c u l t t a s k b u t t o avoid possible contamination and physical damage to stock it is necessary to keep pests out of the pharmacy premisesPest control measures should be implemented with proper p r e c a u t i o n s t a k i n g u t m o s t c a r e t o a v o i d contamination of medicines

55

Th e following pest control measures c a n be ta ke n f r om tim e to tim e -bullbullRat bait and traps can be placed at various locations bullbullInsecticutors can be used on a permanent basis bullbullInsecticidal sprays and repellants can be used from time to time

i i i ) Fire precautions

Combustible trash such as cartons boxes and other packing waste must not be allowed to accumulate in the store Waste should be deposited in appropriate waste bins and be d i s p o s e d o f f o n a d a i l y b a s i s

F i re detection and fire fighting equipment must be maintained and regularly inspected The pharmacy personnel should receive adequate training in fire fighting techniques and emergency actionFire prevention measures should include a prominently displayed ldquoNoSmokingrdquo sign careful handling and disposal of combustible waste materials and checking of electrical connections at regular intervals

iv) Security middot Doors shutters of the pharmacy should be strong and be fitted with secure locks middot Counters should be designed so that unauthorized personnelclients do not have

access to areas where prescription medicines are stored Access to such areas should be restricted to the pharmacy staff

middot All the pharmacy staff handling supplies should be accountable for their ac t i o n s

56

middot bullSpecial care must be taken in case of Schedule X and manufactured drugs (under NDPS Act) Such medicines should be kept under lock and key and the key should be kept with the Chief Pharmacist or i n h i s a b s e n c e t h e s e n i o r p h a r m a c i s t

v) Breakagespillage and damaged product Products that have been damagedspoiled during storage and handling spillages and broken glassware should be disposed off according to procedures laid down by the pharmacy Broken and damaged products s h o u l d b e p l a c e d i n a segregated area to be returned to the supplier

vi) Inspection Senior staff should inspect all pharmacy areas regularly The shelves and drawers should b e c h e c k e d d a i l y f o r signs of pests and dust Ceiling and walls should be checked for dirt and cobwebs Stock should be checked on a regular basis for deterioration due to climatic conditions

43 Product recalls Products found to be defective should be quickly recalled (withdrawn from the market) The instructions are generally issued either by the manufacturer or the regulatory agency The level of recall is determined by both the degree of risk and the extent of distribution of the product and in India is mainly directed at the distribution chain

On receiving the details of the defective substandard spurious batchbatches of a medicine to be recalled from the manufacturer or the stockist or the FDA the pharmacy should immediately check if the particular b a t c h i s i n s t o c k a n d i f s o s u s p e n d i t s s a l e immediately

Similarly if the regulatory authority in the country bans a particular medicine or FDC the pharmacy should immediately check and remove all the different brands of that particular medicine under consideration

The details of medicines and their batches to be recalled should be available in the q u a r a n t i n e a r e a w h e r e stocks are received and checked This is to ensure that such medicines do not come into the pharmacy

middot The pharmacy should develop SOPs for recall of medicines middot The pharmacy staff should be immediately informed about such medicines and

the details should be displayed in writing in a prominent place in the pharmacy middot Rapid action helps avoid unnecessary exposure to such medicines once the

problem has been d e t e c t e d middot The progress of the recall procedure in the pharmacy should be monitored every

few days to ensure complete compliance middot All stocks of the recalled products should be stored separately from the saleable

stock These can be stored in the expiry cupboard segregated from the expired goods and be appropriately labeled ldquoRecal l e d G o o d s - Not for Salerdquo

The supplier should be notified and asked to replace defective products middot All the details of the procedures followed should be duly recorded in a Recall

Register maintained specially for the purpose The register should include d etails such as -middot Date of the recall middot Nam e of the product

57

bullbull

middot Details of the product (name of manufacturer batch number expiry date) middot Nu m b er of units purchased sold a n d sto c k in ha nd middot Reason for recall middot Nam e of the supplier to whom produc ts w e r e returned along with the date and quantity middot Name and signature of the designated personnel carrying out the recall procedure and recording details middot Name and signature of the chief pharmacist verifying the recall procedures and recording details 4 4 Returned medicines

Medicines may be returned to the pharmacy by clients due to the following reasons -bull

bullbull Unused medicines bullbull Course not completed bullbull Therapy changed by doctor bullbull Side effects experienced by patient bull

bullbull DamagedDefective medicines bullbull Missing or defaced label bullbull Missing tablets in a stripblister bullbull Leakage in bottles bullbull Leakage in strips bull

bullbull Expired medicines

Appropriate SOPs should be framed and followed for their acceptancerefusal and disposal middot bull For unused medicines returned by clients the p harmacy personnel should verify

that these were purchased from their pharmacy They should then be checked for integrity of the packing the dosage form and the expiry date and verified with the client whether they were stored in appropriate conditions This again is at the discretion of each pharmacy

middot The damageddefective medicines returned to the pharmacy should be taken back and stored separately Existing stock of the same product should be checked for similar defects

middot Expired medicines should be accepted from clients at the discretion of the pharmacist and be immediately shifted to the expired goods cupboard These can be stored segregated from the pharmacys own expired goods and be appropriately labelled ldquoExpired Goods returned by clients- Not For Salerdquo

It is advisable not to accept returned medicines requiring cold chain storage (refrigeration) because it cannot be ensured that the cold chain was maintained when the medicines were in the hands of the patientclient middot Appropriate adjustments in t he stocks should be made for medicines

returnedexchanged to update the inventory middot The medicines should then be returned to the respective shelves middot A lsquoReturned Goodsrsquo register needs to be maintained to record all details of returned

medicines

R egister should include such details as-

58

middot N a m e o f t h e p a t i e n t middot Nam e of the product and quantity r e tu r n e d middot Product details such as the batch number and expiry date middot Condition in which received middot Reason for returning products middot Compensatory measures taken wi t h r e s p e c t t o c l i e n t middot Action taken with respect to product middot Name and signature of the personnel accepting the returned medicines and recording details middot Name and signature of the chief pharmacist verifying the recorded details

What the pharmacist would have learnt from this module The storage of medicines is a critical factor in the distribution cycle bullbull Stocks received by the pharmacy should be quarantined in a separate area and necessary checks s h o u ld be performed to ascertain the qua lity a nd quantity of stocks received bullbull Whatever pattern and means of storage used the products should be stored so as to maintain their potency and integrity bullbull Storage conditions should be monitored and maintained on a regular basis bullbull Optimum stock levels should be maintained and regularly monitored for expiry bullbull The design of storage areas should facilitate appropriate storage of medicines bullbull Cleanliness should be maintained in the pharmacy bullbull Adequate measures should be taken in case of returned medicines and recalled products

Optimum storage of medicines is mandatory whether at the distribution stage at the pharmacy or ultimately within the homes of patients The pharmacist has an important r o l e t o p l a y i n t h e s t o r a g e o f m e d i c i n e s i n m a i n t a i n i n g d r u g p o t ency and efficacy and thus facilitating optimum therapeutic benefits Good Pharmacy Practice - IPA -CDSCO - WHO Appendix I Quality Assurance Templates of letters for use if found not of Standard Quality [Frozen and expired goods ]

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated To Name of the Supplier with address

Sub Not of Standard Quality GoMP-Supply of Drugs and medicines-(Codename) Return of Stocks to the Suppliers-reg(New drug policy 2009) Previous letterinvoice ref Sl No Drug Code Drug name

Manufacturing date Expiry date

Supplier address

B a t c h n o

The above items of PO nodated was drawn by the Drug Inspector (Place) on (______________date) as a statutory sampling and declared ldquoNot of Standard

59

Qualityrdquo on -(______________date) by the Government Analyst for the following reasons

- ldquoThe product sample do not confirm to IP specification for (Drug codename with respect to the content of drugrdquo

- ldquoThe product has already been blacklisted by TNMSC on -(______________date) for the failure of (quantity) of batches of drug codenamerdquo

As per the clause of the te nde r d oc um e nt ldquo I f the sa mple s d o not c onf o r m to statutory standardsthe tenderer will be liable for relevant action under the existing laws and the entire stock in such batch should be taken back by the tenderer within a period of 30 days o f t h e r e c e i p t o f t h e l e t t e r f r o m t h e v e n u e

The stock shall be taken back at the expenses of the tendererthe Procurement Authority have the right to destroy such Not of Standard Quality if the tenderer does not take back the goods within the stipulated time

The Procuring Authority will arrange to destroy the Not of Standard Quality drugs within 90 days after the expiry of 30 days mentioned above without further notice and shall also collect demurrage charges calculated at the rate of 2 per week on the value of the drugs rejected till such destructionrdquo

Hence we regret to inform you that you will have to take back the stocks available of the abovesaid batch at your own cost from the drug stores where you have supplied the above batch

Kindly acknowledge the receipt of this reference at once

P r o c u r e m e n t A u t h o r i t y Seal and Stamp

Copy to Ref No dated

1 ) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated13082010

To

Sub Frozen Drugs-ordered to return to the Suppliers-reg(New drug policy 2009) Previous letterinvoice ref

The following products which were earlier frozen have now been ordered to return to suppliers directly with permission from the State drug Authority In this regard the suppliers have been instructed to take back their failed batch from the drug store of the stores Hence you are now instructed to return the following failed batches to the suppliers by obtaining proper authorization letter and acknowledgements from them

60

Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

Kindly acknowledge the receipt of this reference at once

Procurement Authority Seal and Stamp

Copy to

Ref No dated 2) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated14092010

To

Sub Frozen Drugs-ordered to return to the Suppliers- for issue of gate pass after verification reg(New drug policy 2009) Previous letterinvoice ref

The following products which were earlier frozen have now been released Hence they may be issued Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

Kindly acknowledge the receipt of this reference at once

Procurement Authority Seal and Stamp

Copy to

61

Ref No dated 3) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated

To

Sub Stop instruction-reg(New drug policy 2009) Previous letterinvoice ref

Until further instructions stop issue all the batches of the following item Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

You must intimate the available stock in the stores of the said batch Number to the Procurement Authority immediately Also retrieve quantity if already issued

Procurement Authority Seal and Stamp

Copy to

Ref No dated 4) HOD Procurement Office of

62

Appendix II Material handling in drug stores

Rack approx rates and dimensions

S No

Item Description UOM Approx Rate

1 MEDIUM DUTY RACK SIZE 2900 H X 3090 W X 800 D IN MM (AS PER SPECIFICATION)

Each 2499800

2 MEDIUM DUTY RACK ADD ON UNIT FOR SIZE OF SR NO2

Each 2243100

To locate a Box no 3 Rack no 14 in row3

SAMPLE OF RACK no Bin numbering -------------- S a y R K 1 4 R o w 3 B o x 1 6

SAMPLE LAYOUT of RACKS in a Drug Stores

63

Sample of another warehouse of distribution warehouse system

64

65

Slotted Angle racks with bin cards

66

Plastic Pallets

Plastic pallets ar e l i g h t w e i g h t l o w- c ost and exceed industry standards for strength and durability

NOTE A pallet has bottom deckboards (see sketch) A skid does not have bottom

67

deckboards

Battery Operated Stacker

Electric Stacker Ehh (Manual Push Type) - Manual drive - Lifting electrically with Battery 12 V 88 Ah - For loading and un-loading of trucks - Battery and loading device built - in - Battery charge gauge and charging current gauge Simple and Easy Operation - Lifting and Lowering electrically direct on steering arm - Pulling and pushing through steering arm - Electrically operated relief valve on hydraulic aggregate Safe Operation - Emergency Off Switch - Constant lowering speed - Protection through lowering brake valve - Overload protection through overload brake valve - Load chains covered preventing pinching threat - Electrically interlocking during loading process - Secured battery compartment opens upwardly - Stable buffering of the steering arm in upright position - In accordance with EWG Guidelines 89 240 - In accordance with VBG 12b Prevention of Accidents

Pallet Truck [ Top ]

68

----------------------------------------------------------------------------------------------------------------------------

For Transport Of All Goods On Pallets Safe and Easy Operation - through single hand operation Lifting moving

lowering with steering handle - neutral position of the hydraulic possible - overload pressure relief valve Long Service Life - robust co n s t r u c t i o n

- special hardened axles - hardened chromium plated ram - maintenance free Easy Maneuverability - through rubber steering rollers - nylon fork rollers

A h a n d t r o l l e y

69

Trolley with plastic bins for several items del ivery

70

Digital Weighing balances

Balances amp Scales EF Seriers Precision Electronic Balance

71

1

Ice lined Refrigerators

600 litres refrigrator

72

Walk in cooler

vacuum cleaner

73

FLOWCHARTS

middot EASY UNDERSTANDING OF THE PROCESS INITIATION O F T H E

PROCESS OF EMPOWERED PROCUREMENT WING-ldquoDRUG

C E L L-DIRECTORATE HEALTH SERVICESMADHYA PRADESHrdquo

middot UNDERSTANDING THE REQUIREMENT amp CHOOSING THE

CORRECT METHOD OF PROCUREMENT WITH APPROVAL OF

THE PURCHASE AND TECHNICAL COMMITTEE AS PER THE

DRUG POLICY

middot T HE TENDERING PROCESS

middot BRIEF OF THE PROCEDURE TO BE ADOPTED AFTER THE BIDS

ARE FINALISED

Flow Charts

P r o p o s e d S y s t e m I n i t i a t i o n

5

6

bull S y s t e m

7

bull System of Tendering at a Glance

8

DIRECTORATE OF HEALTH SERVICES MADH YA PRADESH

No Q E q p O c t 7 7 Bhopal the 2 6 th October 1977

(E x t r a c t e d f r o m t h e G O and reproduced f o r 2 0 1 0 -11 to have clearity on process of

procurement )

To

The Deans

The Divisional Joint Directors of Health

Th e J o int Director of Ayurveda

The Administrative officer ESISIndore

The Superintendents of Medical College Hospitals

The Superintendents of Special Hospitals

The Civil Surgeons

The District Family Welfare cum Health Officers

The Principals RHFWTC

MADHYA PRADESH

Subject -Rules Orders for management of stores

The Government of Madhya Pradesh in the department of Public Health and family Welfare have by their order No 305847795-2877MedIII dated the 13 th

October 1977 issued Rules for the management of STORES These come int o force from the day they are received by the officer-i n- charge of an institution

It is desired that these Rules be followed strictly both in lsquoletter and spiritrsquo and no explanations would be accepted for non-compliance

Sufficient number of printed cop ie s a r e be ing se n t to you f o r d istr ibution a m ongst your subordinate staff concerned with the subject

A C Gaur For Director Medical Services

Madhya Pradesh

9

ACQUISITION OF STORES

The word Stores used hereunder applies generally to all articles expendable as well as dead stock of the nature of plant machinery instruments furniture fixtures medicines linen etc etc

Any authority which is competent to incur contingent expenditure may sanction the purchase of stores required (sub ject to his d e le ga tion of f ina nc ia l pow e r s) pr o vide d the following rules are observed-

(a) A Purchase Committee comprising of atleast three Gazetted Officers is formed for approving quantity and quality of stores required

( b ) An enquiry for the articles purch ased should be sent out to various manufacturers and dealers if the total of the order is for Rs 15000 or less In case the purchase order is likely to exceed Rs 15000 ldquoopen tendersrdquo be called through news paper publicity ( f igur e s p e r ta in to 1 977)

(c) Stores s h o u l d n o t b e p u r c h a s e d i n s m a l l q u a n t i t i e s and often if such store is not perishable

( d ) Requirement of the whole year to be worked out a nd n o stor e sh ould b e p ur c h a se d in e x c e ss o f the requirement

(e) P u r c h a s e s h o u l d b e m a d e i n t h e m o s t e c o n o m i c a l manner but q ua lity ne e d not be sa c r if ic e d in the interest of the economy

(f) The details regarding the quality desired and expected purchase quantity should be mentioned in t h e e n q u i r y

(g) Purchase order should not be split up to avoid the ne c e ssity o f obta ining th e sa nc tio n o f t h e h i g h e r authority

( h ) The date and time of opening of the tender should also be published and in case the tenderers desire to be p r e se nt o n th e o c c a sio n th e y should b e a llo w e d t o d o s o

( i ) Mere initialing on the covers of the tenders is not sufficient All the Purchase committee members s h o u l d s i g n o n e a c h a n d e v e r y p a g e o f t e n d e r q u o t i n g t h e r a t e s A n y r a t e s w h i c h h a v e b e e n overwritten by the tenderer should not be c o n s i d e r e d u n l e s s t h e y b e a r t h e t e n d e r e r rsquo s s i g n a t u r e and subsequently signed by a member o f t h e Purchase committee

( j ) A list of tenders opened should be made out and t a l l i e d w i t h t h e o n e o f t h o s e r e c e i v e d i n t h e o f f i c e Such a list should be signed by all the members of the Purchase committee

( k ) A comparative statement is then made and lowest t e n d er i s a c c e p t e d s u b j e c t t o q u a l i t y o f f e r e d b e i n g

10

satisfactory Samples of non perishable articles should be preserved safely under lock and key for comparison till the contract for supply is in force

( l ) R e a s o n s for rejecting the lowest tender and accepting the h i g h e r o n e s h o u l d a l w a y s b e r e c o r d e d in writing by the Purchase Committee

(m) No reason for rejecting the lowest tender need to be communicated to the tenderer

( n ) Every purchase order should clearly mention that the articles ordered shall be accepted subject to t h e approval of the Purchase Committee

( o ) Rules regarding deposition of earnest money and security money should be observed

( p ) For emergent purchases in public interest when there is no time to observe Store Purchase Rules purchases should be made up to Rs 2 5000 (refers to year -1 9 7 7 ) a t a t i m e A s f a r a s p o s s i b l e t h i s practice should be avoided

II PLACING OF ORDERS (a) For medicines and such other articles which the Medical Stores Depot Bombay

supplies order be placed with them at a specified time ( b ) For articles not on the Bombay Stores Depot Bombay lsquolimitedrsquo or lsquoopenrsquo

tenders be invited as the case may require It would be preferable to place orders on the manufactures or their authorized distributors

(c) For placing the orders on PSUrsquos Laghu Udyog Nigam or Organisations approved by the State government no tender needs to be invited

( d ) Price preference upto 10 is available to Small Scale Industries of this State only(not applicable as per New drug policy 2010 -1 1 )

III RECEIPT OF STORES All materials received should be examined counted measured or weighed as the

case may be when the delivery is taken The stores thus verified be may be immediately entered in the stock register Book under proper headings and this fact should be recorded on the body of the bill mentioning the page number of the Stock Book It should also be mentioned whether the quality and the quantity are correct as per the requirement Soon after the receipt each item be stamped with the initials of the institution

IV CUSTODY

(a)The head of the institution should ensure suitable accommodation for keeping the stores with a view to prevent losses through theft accident fraud or otherwise

(b) Separate Stock Accounts should be kept of-( i ) D e a d S t o c k-such as plantmachineryfurniture equipmentinstruments

etc (ii) Expendible items such as medicineslinenrubber goods etc (iii) Perishable articles

(c ) all recepts and issues in the stores stock registers should be on the authorityand under the signature of a respon sible officer deputed for the purpose

11

V ISSUE OF STORES (a) When materials are issued from stock the officer -i n ndashcharge should ensure that the indent is in proper proforma (Annexure A) and the person taking delivery is an authorized one (b) The issue vouchers (Annexure B) for articles should be prepared in triplicate by one single stroke of pen The first copy will remain with the records of the stores The second and third copies will go to supplies The second copy will be retained by the person receiving the supplies and the third copy will be returned by the receiver to the stores after making entries of hisher stock book page number etc against each item ( C ) E v e r y t i m e i s s u e b e r e c o r d e d i n t h e s t o c k b o o k o f t h e s t o r e s w i t h s i g n a t u r e s o f t h e O f f i ce r i n -charge

(d) Every issue made from the Central Stores to other institution should show cost of article preparation of Annual Stores Account at a later date

VI Maintenance of Stock Books (a) Stock book should be kept under the charge of a responsible person and should be

saved from loss and destruction ( b ) While making new entries in the main Stores Stock book cost of each item

should be entered though this need not be done in the case of registers in Wards Operation Theatre Out door etc

(c) There should b e n o o v e r-writing or interpolation or smudging of figures Any f i g u r e i f i t i s t o b e c o r r e c t e d s h o u l d b e c l e a n l y c u t a c r o s s a n d t h e n e w f i g u r e should be written by its side or below it under proper attestation

( d ) Stock books should always have a page count(each page be numbered) A certificate showing the number of pages be given on the first and the last page under the signatures of a Gazetted Officer

(e) Receipts issues and balances should be worked out for every item and attested regularly by the Offic er-i n -Charge of the Stores

(f) In the receipt column details regarding the size quality and any special features if t h e r e b e s h o u l d b e r e c o r d e d e g i n t h e c a s e o f A l m i r a h i t s s i z e a n d w h e t h e r i t i s of Steel or Wood

(g) In the Stock-book of library Edition and the ye a r o f p ublic a tion of th e book should always be mentioned

( h ) In case of medicines having an expiry date a list of such medicines be made out and should be checked every week Two months prior to the date of expiry if the s t o c k i s s t i l l f o u n d s u f f i c iently high intimation should be given to Directorate of Health

(i) N o r e m o v a l o f d e a d s t o c k s h o u l d b e m a d e f r o m t h e s t o c k ndash B o o k u n l e s s s o a u t h o r i z e d b y t h e c o m p e t e n t A u t h o r i t y

(j) While making a new Stock book and transferring the stocks therein it should ensured that the page number of the old stock book is shown in the new stock b o o k a n d s i m i l a r l y p a g e n u m b e r o f t h e n e w s t o c k b o o k i s m e n t i o n e d i n t h e o l d one This has to be done to facilitate cross checking whenever desired

( k ) T h e r e h a v e t o b e d i f f e r e n t s e t s o f proforma for dead stocks and for expendable items

Annexure ldquoCrdquo is for former and Annexure ldquoDrdquo for the latter varieties

12

VII PROCEDURE OF INDENTING FOR WARD amp OTHER SECTIONS OF THE INSTITUTION

(a) There has to be an Indent Book with every such section wh ich receives and issues medicinesequipment

( b ) The indent shall be prepared by the nurse Compounded -i n -c ha r g e of th e WardSection in te single copy on the Performa (Annexure A)

(c) The indent so prepared will be signed by the medical officer resident ndash i n c h arge or in his absence by a doctor senior to him but associated with the ward section

( d ) The indent shall then be signed by the head of the institution (Superintendent or the Civil Surgeon as the c a se ma y be ) o r b y his A ssista n t if th e la tte r is so authorized in writing

(e) The indent book is then presented to the main Store for effecting issue (f) The Store will then prepare issue vouchers (Annex B) in triplicate as directed

in Paragraph V (b) supra The supplies and the Indent Book are taken back by the Ward Section- i n - charge after signing the first copy of the issue voucher

(g) Te supplies after arriving in the WardSection shall be entered on the WardSection stock register which is prepared on a proforma (Annexure E) and page number of each entry be shown o n t h e 2 n d a n d 3r d copies of the Issue

voucher The 2 n d copy of the voucher is to be retained in a file in the wardsection but the 3r d c o p y s h o u l d b e r e t u r n e d t o t h e s t o r e b e f o r e s u b m i t t i n g a fresh indent The Store has to be maintain separate files of the 3 r d copies Wardsection-wise

VIIIHOW OFTEN TO INDENT

(a) A wardsection ndash i n -charge should work out an average weekly expenditure of each item and efforts be made to replenish the WardSection stocks every week

( b ) T h e M a i n s t o r e i n o r d e r t o a v o i d h e a v y rush of work should fix a day of issue for each major specialty T w o or th r e e minor spe c ia ltie s c a n be gr o upe d f o r one day

IX EMERGENT INDENT It is very likely for unforeseen reasons either the weekly indent of WardSection stock might get exhausted earlier or something which was not there in the lsquoweekly indentrsquo is required Under such circumstances an ldquoEmergent Indentrdquo could be made out in the usual manner but under the signature of the Unit-i n- chargeconsultant and it must be countersigned by the head of the institution (and not by his assistant) These supplies have also to be entered in the wardSection stock books like others

13

X HOW TO INDENT

(a) The ward Section -i n - c h a r g e s h o u l d e n s u r e t h a t t h e s t o c k s u n d e r t h e i r c h a r g e a r e not unnecessarily large and only a realistic quantity is indented once a week

( b ) The indent should not be made out in the names of the patients or by bed numbers The indent should be for the Wardsection as a whole

XI KEEPING OF RECORDS IN WARDS AND SECTIONS

(a) A set p r o f o r m a ( A n n e x u r e E ) s h o u l d b e u s e d i n t h e w a r d s e c t i o n f o r s h o w i n g u p receipts and issues Balance of expenditure for each item to be drawn out every morning by nursecompounder in charge before writing out the Indent or before restarting work The medica l O f f ic e r r e side nt in c ha r g e sh ould a tte st th e e ntr ie s after satisfying himself- by random checking at least once a week

( b ) To support the above mentioned expenditure the Bed head Tickets (treatment charts) are very important Each medicine prescribed should be legibly written indicating the total quantity prescribed if the medicine is to be deleted from treatment the fact should be mentioned as to how much of the drug was issued to the patient before switching on to another drug The suggestion is that a separate treatment card be maintained for each indoor patient ( Annexure ndash G) A summary s h o w i n g t h e t o t a l a m o u n t o f t h e p r o p r i e t a r y d r u g s c o n s u m e d b y t h e p a t i e n t d u r i n g is hospital stay be worked out and noted in the summary card

XII ACCOUNT ABILITY OF DRUGS BROUGHT BY THE PATIENT OR RECEIVED IN DONATION BY THE WARDSECTION _IN -C H A R G E

The drugs receoived from the non - governmental sources should be entered on the receipts side of the WardSection Sto c k b ook a n d issu e s to show n a s in th e o the r cases on the issues side

XII RSPONSIBILITY OF STORES AT VARIOUS LEVELS (a) The head of the institution shall be held responsible for non-observance of

rulesprocedures laid down by the Government ( b ) The Medical officerresident in charge of the stores and the store keeper shall be

held responsible for any irregularity found in the stores or for ignoring the ordered pattern of working It shall be the duty of the Medical officer Incharge of the Stores to occasionally check the WardSection Stock-b o o k s t o t a l l y t h e e n t r i e s made in the 3 r d copy of the Issue vouchers [as laid down under V (b)supra ]

(c) The Medical officerresident in charge of the WardSection shall be responsible for irregularities in indenting stocksfor maintaining stocks much in excess of the req uirement and for improper keeping of BED HEAD TICKETS (treatment chartsCards)

( d ) The NurseCompounder ndash i n -charge of the WardSection shall be responsible for shortages in stocks for putting up inflated indents and or for not taking into account medicines b rought by the patientson the WardSection stock-books Heshe shall also be held responsible for ensuring proper distribution of medicines to each and every patient under his her charge

XIV DISTRIBUTION OF MEDICINES FROM OUTDOOR DEPARTMENT (A) ( a ) T h e r e are proprietary and non -proprietary medicines (like mixtures ointments

and lotions) which are to be distributed gratis to patients 14

(b) The Outdoor incharge shall arrange to maintain a stock of common drugs (list of which shall be prepared by the Head of t he Institution) and arrange to replenish the stocks once a week as has been laid down for wards (c) No proprietary drugs shall be issued on the prescription of an intern ( d ) The Head of the institution shall make out a list of drugs which can be issued on

the prescription of a houseman from the Outdoor stock without the countersignature of any other authority

(e) The residents can prescribe any drug from Outdoor stock without the counter signature of any authority

(f) The Consultants can prescribe any drug to any ot h e r o u t e r p a t i e n t e v e n i f i t i s n o t s t o c k e d i n t h e o u t d o o r b u t t h i s s h a l l h a v e t o b e c o u n t e r s i g n e d b y t h e h e a d o f t h e institution for issue from The Main Store

(B) T h e p e r s o n i n c h a r g e o f t h e O u t d o o r m e d i c i n e s s t o c k s h a l l k e e p a r e c o r d o f t h e q u a n t i t y o f t he medicines issued to each patient and instead of writing the name and other details e may only put down the Registration number of the patient and the quantity issued

At the end of the day he must work out the total expenditure of eac item and draw it s balance

The Medical officer in charge of the Stores and the Head of the institution sould check these records at least once a week and affix is signature to confirm their inspection

(C ) No proprietary medicine shall be issued without a valid issue s l i p ( A n n e x u r e- F)

(a) For Housemen the slip would be of brown colour ( b ) For residentsDemonstrators it shall be of pink color (c) For consultants the issue slip should be white ( d ) All issue slips should be printed and pages serially numbered (e) T h e d o c t o r s t o w h o m s u c h i s s u e s l i p s w o u l d b e i s s u e d s h a l l b e h e l d

responsible for their sa f e ke e ping a n d th e y w ould e n su r e tha t th e se slip s would be printed and serially numbered

(f) The doctors prescription slips (for issue from hospitals) of proprietary drugs be prepared in du plicate with the help of carbon One copy should be given to patient for obtaining medicines from the Stores and the other would remain in the Doctors Prescription Slip book

(g) Every issue Slip should be signed and below the signatures a rubber s t a m p s h o w i ng name and designation be affixed The Store people would n o t h o n o u r s l i p u n l e s s t h e n a m e o f p r e s c r i b e r i s c l e a r a n d h i s a t t e s t e d signatures are available to stores

( h ) The Store Staff would file prescription slips of each doctor separately to facilitate the scrutiny at least once a month by the Head of the Institution Such a Scrutiny would reveal over prescribing of or injudicious use of drugs

(C) Proprietary medicines should not be issued for more than three days requirement at a time The only exceptions being cases for cancer pulmonary tuberculosis and leprosy In exceptional cases an officer not below the rank of a Consultant can prescribe for more than 3 days but after the countersignatures of the Head of the Institution

15

XV LOSS BREAKAGE DAMAGE ETC

(A) Any loss of public money departmental revenue of receipts stamps stores or other property held by or on behalf of the Government caused by defalcation or otherwise discovered in an office or institution should immediately be reported by the officer concerned to the head of department through his immediate superior as well as to the Accountant General if the loss exceeds Rs 20000(fig of 1977) (for Proforma see Annexure I)even when such loss has been made good by the party responsible for it Such reports must be submitted as soon as possible and soon after suspicion arises that there has been a loss they must not be delayed while detailed enquiries are made

When the matter has been fully investigated further and complete report should be submitted of the nature and extent of loss showing the errors or neglect rules by which such loss showing the errors or neglect of rules by which such loss was rendered possible and prospects of effecting such recovery

The s ubmission of such a repot does n o t d e b a r t h e l o c a l a u t h o r i t i e s t a k i n g f u r t h e r a c t i o n which may be deemed necessary like handing over the case to the police

Every Government servant should realize fully and clearly that he will be held personally responsible for any loss sustained by the government through fraud and negligence on is part and that will also be held personally responsible for any loss arising from fraud or negligence on the part of any other Government servant to extent to which it may be shown that he has contributed to loss by his own action or negligence

A s s o o n a s s h o r t a g e i n s t o c k o r l o s s i s d i s c o v e r e d a p a r t f r o m r e p o r t i n g t h e m a t t e r a responsible officer should be deputed to investigate the matter

W h e r e t h e r e i s n o l i k e l i h o o d o f a d e l i b e r a t e t h e f t b u t l o s s i s a result of neglect onlythe loss should be made good by the person on whose charge or custody the article lost remained

(B) As soon as damage or breakage of Government property is detected certain steps mentined under should be undertaken-

(a) A p r o m p t t h o ro u g h i n v e s t i g a t i o n i n t o t h e c a u s a t i o n o f b r e a k a g e o r d a m a g e s h o u l d be undertaken by the doctor-i n -charge of the WardSection or by the Head of the Institution

( b ) The investigating officer should draw conclusions as to whether the breakagedamage has been a result of-

(i) C a r e l e s s a n d n e g l i g e n t h a n d l i n g ( i i ) Unpredictable action of the patient for whom the equipment was

being used (iii) Accidental ( i v ) Manufacturing Defect

A report is then prepared in duplicate by person in charge of the article under question on the lsquobreakage and loss proformarsquo (See Annexure H)

16

These reports have to be signed by the investigating officer and are to be then submitted to competent authority for suitable action One copy which is returned is to be kept with the Stock Register In cases where the b r e a k a g e o r d a m a g e i s o f s u c h b i g g e r d e g r e e t h a t s atis factory repairs are not possible a n d if suc h b r e a k a ge o r da m a ge is o f su c h a de gr e e that satisfactory repairs are not possible and if such breakage or damage has been caused-

( i ) B y a G o v t s e r v a n t because of negligent or careless handling cost of the article should be recovered from him and credited to the treasury (ii)On account of reasons mentioned above that is un predictable action of the patient accidental or manufacturing defectthe article could be written offsubject to powers delegated to the concerned for such purpose

(C )Shortages detected during biannual physical verification of the Storeshave to be dealt in a similar manner

(D) it shall be at discretion of the competent authori ty (who is empowered to write off the loss) to reduce the amount of recovery upto 50 of the cost of article provided that before arriving at such a decisionhe has taken into account the following points (a) Normal life span of the article under questi on (b) Period for which it has been in use (c ) Condition of the article at the time of loss or damage and (d) Whether it was on account of careless or negligent act or not

XVI PROCEDURE FOR WRITING OFF STORES

(a) When any Stores become unserviceable otherwise than in ordinary course or by fair wear and tear their value should be treated as loss to the Government and in such cases cost should be recovered from the person responsible for his negligence

( b ) A s t r i c t w a t c h s h o u l d b e k e p t o n t h e m e d i c i n e s w h i ch bear an expiry date and if there is no likelihood of their being utilized locally intimation of the fact should be sent to Directorate of Health services and also to all o t h e r d i s t r i c t s s i m u l t a n e o u s l y s o t h a t t h e y c a n b e p u t t o u s e b e f o r e t h e expiry date In the event such a course is not followed and the Government i s p u t t o l o s s c o s t o f t h e m e d i c i n e i n q u e s t i o n s h a l l b e r e c o v e r e d f r o m t e defaulter

(c) For declaring articles as unserviceable a Committee of three members should be formed in each officeinstitution This Committee should examine each and every article brought before it and should record full reasons for condemning them and also say how the articles condemned have to be disposed of-whether by sale (by public auction) or otherwise

I f t he local Authority is not competent to write off the articles condemned by the Committee it should send the proposal to the higher authority for suitable a c t i o n

17

In Institutions where there is only one doctor a list of articles to be condemned should be p r e p a r e d a n d o r d e r s o n i t b e o b t a i n e d f r o m t h e inspecting authority during inspection

While preparing any list of articles for condemnation details regarding the date of purchase date of receipt period during which it remained in use usual life of the article and its purchase price should be noted against each item

( d ) The condemned articles should not be struck off the Stock Register till the competent authority sanctions its write ndashoff Details of Authority under which the article has been written off should be mentioned in stock register

XVII DISPOSAL OF WRITTEN OFF ARTICLES

Articles like linen should be torn into strips 10cm width so that they could be burnt or given to Government Jails for making carpets

Items like bed -pans bowlsurine po ts etc should be crushed and kept for auction

Brass utensils have also to be crushed to destroy their shape and could be either auctioned or after inviting rates from several dealers could be locally sold to highest bidder

In case when condemned ar ticles have to be sold by public auction they should be stored safely and the Government Auctioneer be intimated In case he expresses his inability to undertake the auction the officer should proceed with the auction departmentally The sale proceeds in either case should be credited to the Treasury as miscellaneous receipts under the Proper head of account

XVIII PHYSICAL VERIFICATION (a) The stocks held by officesinstitutions in various sections should be physically

verified twice a yearin the months o f April and October ( b ) Checking should be done by an officer other than te one who holds the charge of

Stores (c) Verification should be done in presence of officer holding the charge of Stores ( d ) All discrepancies found during the verification should be properly investigated

and accounted for

(j) Any excess detected during verification should be entered in the Stock book as Receipts with the remark ldquo Excess found on verificationrdquo

(ii)any shortage should be noted in issues column of lsquo Issuesrsquo described as lsquoshortage fou n d o n v e r i f i c a t i o n rsquo

XIX ANNUAL STORES ACCOUNT This account should be prepared according to the instruction issued from the department from time to time This should account for the outgoing financial year on the following lines -(a) Cost of the articles under various heads on the last day of the previous

year 18

( b ) Cost of the articles under the various Heads Received during the year (c) Cost of various articles written off during the year under review ( d ) Cost of the articles on the last day of the year or on the firs t d a y o f t h e

financial year following

19

Annexure A WardSection Indent Register No Issued on

Name of institution Page Folio No

Serial no Name of Article Quantity in Stock

Quantity required

Prepared by Approved by Recd by Note-Indenting Officer to sign and affix seal with name and

designation below the last item to avoid additions in one strokeno issues to be made by storesif Issue vouchers of

previous Indent has not been returned back by the WardSection

20

Annexure B Issue Voucher No (printed number)

Supplied to Wardsection Date

Indent no

Serial no Name of Article Quantity in Stock

Quantity required SB No

Stores-in MO Resident in Sign of charge charge WardSection

NurseCompounder Prepared by Recd Approved by by

Note-Indenting Officer to sign and affix seal with name and designation below the last item to avoid additions in one strokeno issues to be made by storesif Issue vouchers of previous Indent has not been

returned back 1st copy-Stores 2nd copy -Wardsection3rd copy-Tobe reurned to sores with Stock book entries

21

Annexure C

STOCK REGISTER FOR DEAD STOCKS

SERIAL NO DATE OF RECEIPT

Article with description

No of pieces Cost Details of

Bill Signature No Disposed

Date of disposal

Manner of Disposal

with Authority

Value realised Signature

1 2 3 4 5 6 7 8 9 10 11 12

P r e p a r e d B y C h e c k e d b y A p p r o v e d b y

Date Designation Name of Institution

22

Annexure D

STOCK REGISTER FOR EXPENDABLE ITEMS Name of article

Date

From where

received with cost

Quantity Signature To whom issued Quantity Balance Signature

1 2 3 4 5 6 7 8

23

Annexure E

Receipt amp Issue Register for WARDSSECTIONS (one or more pages as per requiremnt for each medicine)

NAME OF MEDICINE RECEIPT ISSUE

DATE Quantity In Stock

Date of

Issue

Issued toMention Bed no amp

quantity (in bracket) (For

Outdoor cases give Regd No)

Balance Signature

24

Annexure -F

OUTDOOR FREE MEDICINE SLIP In Duplicate

Name of Patient Registered No Date

Sr no Name of Medicine Quantity

Seal amp sign of doctor

25

Annexure-G

TREATMENT CARD

WARD NO

NAME OF PATIENT BED NO DATE amp TIME OF ADMISSION DATE amp TIME OF DISCHARGE

DATE MEDICINES PRESCRIBED SIGNATURE

26

ANNEXURE -H

PROFORMA FOR BREAKAGE amp LOSS

NAME OF OFFICEINSTITUTION DATE PLACE

SRNO NAME amp

DESCRIPTION OF ARTICLE

COST DATE OF PURCHASE

REASON CAUSE OF BREAKAGE

RECOMMENDATION OF INVESTIGATING AUTHORITY

Signature

Orders of the Competent Authority

Signature

27

Annexure ndash I Loss- Procedure for Reporting

1 The exact nature of the defalcation 2 The full extent of loss 3 The actual period covered by the defalcation 4 The defects in the negle c t o f r u le s by w hic h the loss was rendered possible

and circumstances which facilitated the defalcation 5 The names of the officials held personally or technically directly or

indirectly and wholly or partially responsible for the irregularity c o m m i t t e d i n t h e c a s e

6 Whether the c a s e a s b e e n J u d i c i a l l y t r i e d i n a c o u r t o r n o t i f s o c o p i e s ( i n duplicate) of the Judgment may please be furnished Copy of police report may also be furnished

7 The remedial measures adopted as safeguards against the losses hereafter 8 The prospects of re covery of the loss and he action taken to effect

recovery together with the amount recovered 9 Head of Account to which the Loss is debitable may be informed

Signature of Head of Office with seal

NoteA copy of this report is to be sent to AGMPThis is as per M P Finance Code Vol I

28

STORAGE AND STOCK MANAGEMENT

29

Foreword

The New Drug Policy 2009 is being implemented in the State of Madhya Pradesh

In order to have a proper procedure for Storage maintenance and expiry management of the drugs it is necessary to follow Good Storage Practices with Standard Modules for pharmacistStore keepers

Proper guidelines on Storage Practices can lead to better Stores and inventory upkeep with medicines being properly stored in racks with proper cleanliness and hygiene

This is a step towards storage maintenance and expiry management at the various stores in the state Looking forward to see that the heads of all health facilities take benefit from this module

D ir e c t o r M e d i c a l S e r v i c e s

30

INDEX

Sr No P a r t i c u l a r s P a g e

1 S T O R A G E A N D S T O C K M A N A G E M E N T 4

1 Quarantine and checking of stocks 11 Quarantine area 12 Checks to be carried out on new stocks

2 S t o r a g e 21 Need for proper storage 22 Different patterns of storage 23 Different means of storage 24 Temperatureclimatic conditions 25 Special storage of supplies 26 Storage and stability of medicines

3 Stock Control and Expiry Monitoring 31 Stock control 32 Stock rotation and expi r y m o n i t o r i n g

4 Other aspects of storage 41 Design of a storage area 42 Cleaning and maintenance 43 Product recalls 44 Returned goods

2 A p p e n d i x 1 Templates of letters for use if found not of Standard Quality [Frozen and expired goods ]

Frozen Drugs-ordered to return to the Suppliers-reg(New drug policy 2009)

Frozen Drugs-ordered to return to the Suppliers- for issue of gate pass after verification reg(New drug policy 2009) Stop instruction-reg(New drug policy

2009) Appendix II Material handling in drug stores

31

3 PROCUREMENT ndash Government Order Relating to

the Management of Stores

(Reproduced for reference material on basic

procedure in decentralized system followed by

Health facilities in 1977)

54

F L O W C H A R T S f o r a BI R D S E Y E V I E W o f

P R O C U R E M E N T

5 5

ACQUISITION OF STORES 6 1

PLACING OF ORDERS 6 2

RECEIPT OF STORES 6 2

CUSTODY 6 3

ISSUE OF STORES Maintenance of Stock Books

6 3

PROCEDURE OF INDENTING FOR WARD amp OTHER SECTIONS OF THE INSTITUTION

6 4

HOW OFTEN TO INDENT 6 5

EMERGENT INDENT 6 5

HOW TO INDENT 6 5

KEEPING OF RECORDS IN WARDS A N D S E C T I O N S

6 6

ACCOUNTABILITY OF DRUGS BROUGHT BY THE PATIENT OR RECEIVED IN DON A T I O N BY T H E WARDSECTION _IN - CHARGE

6 7

RESPONSIBILITY OF STORES AT VARIOUS LEVELS

6 7

DISTRIBUTION OF MEDICINES FROM OUTDOOR DEPARTMENT

6 7

LOSS BREAKAGE DAMAGE ETC 6 8

PROCEDURE FOR WRITING OFF STORES 6 9

DISPOSAL OF WRITTEN OFF ARTICLES 7 1

FORMATS TO BE USED 7 3 - 81

32

STORAGE AND STOCK MANAGEMENT The expiry periods of pharmaceutical products have meaning only if the products are stored under proper conditions otherwise products are likely to lose their potency before the actual date of expiry

A pharmacist is a vital link in the distribution chain for pharmaceutical products The medicinal products remain for a long period during the distribution cycle at the wholesaler and at retail pharmacies It is therefore very important to maintain proper storage conditions in these units

Every community pharmacy however large or s mall needs to store and manage its medicine stocks effectively There must be systems to ensure

middot bullbull Secure storage middot bullbull Clean and correct environmental conditions during storage middot bullbull Accurate and effective record keeping middot bullbull Effective stock rotation and expiry monitoring middot bullbull Effective fire and theft prevention middot bullbull Effective rodent pest control

For easier un derstanding this module has been divided into the following sections

1 Quarantine and checking of stocks 11 Quarantine area 12 Checks to be carried out on new stocks

2 S t o r a g e 21 Need for proper storage 22 Different patterns of storage 23 Different means of storage 24 Temperatureclimatic conditions 25 Special storage of supplies 26 Storage and stability of medicines

3 Stock Control and Expiry Monitoring 31 Stock control 3 2 S t o c k r o t a t i o n a n d e x p i r y m o n i t o r i n g

4 Other aspects of s t o r a g e 41 Design of a storage area 42 Cleaning and maintenance 43 Product recalls 44 Returned goods

33

1 QUARANTINE AND CHECKING OF STOCKS

11 Quarantine Area D r u g S t o r e pharmacies receive stoc k s f r o m su pplie r s a c c or d ing to pur c h a se o r d e r s T he stock that is received must be visually checked for quality and quantity The stocks must be kept in a separate area until the checking is done to avoid intermixing with existing stock This necessitates the presence of a separate area within the pharmacy w h e r e i n t h e storage and other checking of stocks can be performed This area is called the QUARANTINE AREA This area should be marked and identified adequately to distinguish it from other areas

The area may be marked using different means 1 ) A s m a l l board saying Quarantine on a separate table used exclusively if it is in the middle 2) A board on the wall if the table on which the quarantine stock is placed is against the wall

middot Stock received from wholesalers should be immediately transferred t o t h e Quarantine Area

middot In the Quarantine area the stock may be stored on racks shelves or in cupboards to prevent ingress of moisture dirt and other contaminants

middot Regular stocks from the pharmacy should not be left kept in the quarantine area Special care has to be taken in case of refrigerated medicines supplied by the suppliers so tha t the y do not remain in the quarantine area for long periods of time They should be immediately checked on receipt and transferred to areas for refrigerated storage s o a s to maintain the cold chain bull

Advantages of having a separate Quarantine Area middot Avoids cross mixing of newly arrived stock from existing stock till it is checked middot Lays stress on checking the quality of the stock received middot S to ck checking ensures t hat defective andor expired goods do not enter the storage areas

34

bullbull

bullbull

12 Checks to be carried out on new stock

Unpacking and checking stock

Supplies received should be unpacked and checked in the quarantine area Staff doing the checks should be adequatel y trained in what they have to check when stock arrives

Checking should be seen not simply as counting the units received but as a part of the quality assurance system bullThis should include middot Visually inspecting the packaging middot Checking the integrity of containers middot V erifying the completeness and leg ibility of la b e ls ( a ppr o ve d dr u g name strength any special storage instructions and expiry date)

bull

The expiry dat e should be checked to ensure that there is adequate shelf life remaining

Supplies should be individually checked using a checklist 35

Checklists

36

The wholesaler supplying the product should be notified immediately in case of any discrepancies ( and the details should be recorded in a register) and sent in a written format to the supplier It should include middot Missing boxes or cartons middot O p en tampered boxes or cartons middot Missing supplies middot Differences in the actual quantity and the quantity shown on the packing middot Additional medicines that had not been ordered but have been supplied middot D a m a g e d b r o k e n o r p oor quality medicines middot Any other discrepancies

The purchase invoices are an important aspect to be considered The invoiced documents should be signed and filed for reference as per the Drugs and Cosmetics Act and retained for at least 3years

If the wholesaler supplies medicines as an emergency without a bill or against a delivery challan

middot The supplies should be checked for integrity and inspected for damage middot The details of supplies received should be recorded middot The supplier should be asked t o send the bill as early as possible middot When the bill is received it should be checked against the details recorded and anomalies if any should be reported to the supplier

To keep a track of the received stock maintaining a S t o c k R e c o r d C a r d c a n b e very useful The entries in the stock record card can be made while checking the stock received STOCK BIN in the stores should have Stock record card

Maintaining a stock card for every product may not be very practical for a retail pharmacy however it could be maintained for costly medicines Nowadays it is much more practical and easier to maintain records using computers

The pharmacist should ensure that medicines manufacturedmarketed by a company are received only through an authorized distribution network of that company This is important to prevent spurious and counterfeit drugs from entering the pharmacy

37

2 STORAGE 21 The need for proper storage The storage of medicines and other products is an important requirement of Good Pharmacy Pr actice Appropriate storage of medicines is essential -

middot bullTo ensure that the potency is maintained middot bullTo prevent deteriorationspoilagedegradation middot bullTo ensuremaintain physical integrity

To ascertain that the quality and safety is maintained throughout their shelf life Storage requirements need to be considered on 2 aspects

a) Integrity of medicines Medicines should be stored in such a way so as to maintain their integrity and potency middot Maintain the right temperature required middot Protect from excessive humidity middot Keep medicines away from direct sunlight middot Protect from pests and rodents

b) Physical location middot Should be easy to locate middot Accessible middot Orderlysystematically placed

2 2 D i f f e r e n t p a t t e r n s o f s t o r a g e The pharmacist could follow any of the different patterns of storage The pattern of stora ge should be selected in such a way that it facilitates speedy and efficient dispensing of medicines

The pattern of storage could vary with each pharmacy experience usual practiceroutine of staff and the person-in charge and also depending on space av ailable turnover etc (i) The medicines could be stored c o m p a n y w i s e ie the medicines manufactured by one company should be grouped together and kept in one place Within each company shelfshelves the medicines may be placed in alphabetical order for easy and quick placement and removal Also bottles tubes boxes etc may be segregated within that shelf

38

(ii) The medicines may also be stored in a lphabe t ic al o r de r ie they are placed in order from left to right based on their name The first letter of the name is used to g r o u p t h e m e d i c i n e s t o g e t h e r a n d k e e p t h e m i n o n e l o c a t i o n I n s o m e p h a r m a c i e s a l l t h e strip packing are placed in drawers or boxes in alphabetical order each box or drawer containing strips of one particular alphabet This system ensures that the strips always remain e n c l o s e d i n t h e b o x e s d r a w e r s a n d a r e n o t e x p o s e d t o d u s t T h e d i s a d v a n t a g e i s that it might lead to mix -u p o f strips in the same drawer and it may cause a problem incase of similar looking strips in which case a wrong medicine may be dispensed Secondly cut strips lying around in the drawer may lose their identity if the batch n u m b e r andor expiry date is not seen on the cut portion of the strip

39

(iii) The medicines may be stored according to their therapeutic class ( e g a n t i b i o t i c s anti asthmatics or anti hypertensives) ie the medicines are kept together based on their pharmacological or therapeutic action

(iv) The medicines may be stockedsegregated according to dosage forms eg l i q u i d s (bottles) solid oral dosage forms eye drops rotacaps ointments etc all stored on separate shelves

Always Remember I Storage of prescription medicines should preferably be separate from OTC medicines OTC medicines especially those that a r e a d v e r t i s e d m a y b e d i s p l a y e d f o r c l i e n t s t o select or to ask questions about [OTC-O v e r t h e c o u n t e r ] II Storage according to temperatures is a must no matter which pattern of storage is followed Also within a particular storage area segregated storage may be maintained In a refrigerator for example medicines may be stored in trays racks and the freezer according to the temperature required

40

Whatever pattern of storage is selected all the personnel should ensure that middot The stocks are stored in an orderly manner middot The medicines are kept back in the same place from where they were removed middot All medicines are arranged neatly once in a while

middot The personnel should be careful while storing the medicines middot They should not throw the medicines haphazardly 23 Different means of storage

middot Within each temperature and security zone medicines must be stored so that they are easily accessible and protected against damage

middot Basic means of storage include shelves racks and drawers middot To prevent dust from entering the shelvesracks it is ideal to have glass

shutterssliding glass doors This can however be disadvantageous because accessibilityspeed is hampered in removing a product from the shelf because the glassshuttersliding glass has to be

41

opened m o v e d e v e r y t i m e a p r o d u c t h a s t o b e p i c k e d u p U s e o f a i r c o n d i t i o n e r s f o r t h e p h arm acy with a closed door at the e n t r a n c e o r a n a i r c u r t a i n c a n r e d u c e t h e d u s t problem In such cases the shelvesracks may be left o p e n

bull

middot Direct storage of cartons on the floor should be avoided because besides being an unhealthy practice the contents may also be damaged by moisture bull

middot Store medicines preferably in shelves with glass shutters for visibility middot Closed shelves further prevent dust from going in especially in India where most

pharmacies are located along busy roads middot Some medicines have to be refrigerated or stored in a cool or cold place Having a

refrigerator or two (as per the need of the pharmacy) is essential to store suc h medicines at temperatures mentioned on the label bull

42

Refrigeration middot All cold chain equipment should meet required standards middot Improvement in refrigeration technology has provided frost -free refrigerators

Pharmacists should opt for frost-free refrigerators as they are easy to maintain and protect printed packaging materials Conventional refrigerators may cause water falling from trays below the freezer on medicines stored in the refrigerator thus causing soggy labels

middot bull Frost-free refrigerators also provide separate and large compartments for the freezer portion (required for storing medicines needing sub-z e r o t e m p e r a t u r e ) and the main storage area with separate doors so that opening one door does not disturb the storage temperature in the other compartment

Care should be taken to keep the refrigerator on 24 hours a day It should not be switched off after working hours It is advisable to have an inverter connected to the refrigerator so that the refrigerator re mains working even when there is a power outage

middot The refrigerator door should be closed tightly middot The refrigerator door should not be left open for too long middot Space should be left between medicines stored in a refrigerator to allow air to

circulate middot The ref rigerator should be placed about an arms length away from the wall

This will increase air circulation thus not affecting the cooling within the refrigerator

middot Vaccines should not be stored on refrigerator door shelves as they are exposed to warmer temperatures each time the door is opened Vaccines should always be stored on the middle shelves of the refrigerator

middot Refrigerated medicines should not be left out of the refrigerator for more than a few minutes

43

middot Consumable products like juices energy drinks e t c s h o u l d n o t b e s t o r e d a l o n g with medicines in refrigerators If required they may be kept in a separate refrigerator

middot An adequate number of refrigerators should be planned to store the entire stocks requiring refrigerated storage

middot Adequate procedures should be followed for defrosting cleaning and maintenance of refrigerators

middot Icefreeze packs should be kept in the freezer compartment so that they can be used for transporting cold temperature medicines The packs can be given to clients along with the medicines requiring cold temperature storage so that the temperature is maintained till the client reaches home and can then put the medicines in a refrigerator) Freezer packs can also be used to keep medicines temporarily in case there is a power outage or refrigerator breakdown

Activity

Prepare a SOP (Standard operating procedure chart) for cleaning a refrigerator Discuss it with your staff finalize its maintenance once a month through AMC -A n n u a l Maintenance contract CMC - Comprehensive maintenance contract and put it up on the pharmacy refrigerator Put the Purchase Order details name of manufacturer Phone of Service Engineer and a register to login the Machine service and down timeService reports may be maintained properly

Refrigerator monitoring and maintenance

middot bullIt is important to carry out routine monitoring and maintenance of the refrigerators and to organize an effective repair system

middot bullThe temperature in the refrigerator must be monitored and recorded routinely at least once a day

middot Any breakdown must be reco rded including the period during which the medicines were exposed to uncontrolled temperatures Medicines may then be kept or discarded depending on the problem guidelines or the manufacturers advice

middot Cold chain monitor cards and devices in or on packages that change color or otherwise alert staff to potential damage assist in monitoring (These are likely to be introduced in India soon)

middot It is essential to have a contingency plan in place before a refrigerator breaks down An arrangement can be made to move the contents to a private refrigerator elsewhere in the community or to obtain a regular supply of ice packs until the defect is rectified

Put filled water bottles in the bottom half of the refrigerator door in order to provide cooling in the refri g e r a t o r w h e n t h e r e i s a p o w e r o u t a g e T h i s m i g h t t a k e c a r e o f t h e temperature when there is no current for a couple of hours If the power outage is expected to last for several hours special arrangements such as an inverter UPS have to be made to keep the refrigerator constantly running in the absence of electricity middot Defrost the refrigerator in case of excessive ice formation and preferably at regular

intervals Keep a record of the same

44

2 4 T e m p e r a t u r e c l i m a t i c c o n d i t i o n s

i) Temperature control middot The medicines in a pharmacy need to be stored at appropriate temperatures to

maintain their stability middot An air-conditioned environment where temperature can be controlled is

recommended for pharmacies Air conditioning offers the option of setting the t e m p e rature as per requirements

middot bullIt is ideal to have an air conditioner to maintain the temperature below 25 C as most medicines require storage below this temperature Secondly this temperature is pleasing to both the staff and the visiting customers too

middot In the absence of an air conditioner circulating fans may be used middot This need is felt even more in certain parts of India where temperatures soar above 45

C and some areas where it falls to sub zero temperatures In such cases temperature maintenance is essential to prevent deterioration of medicines due to unnecessary exposure to drastic temperature fluctuations

middot This need is felt even more in certain parts of India where temperatures soar above 45 C and some areas where it falls to sub zero temperat u r e s I n s u c h c a s e s temperature maintenance is essential to prevent deterioration of medicines due to unnecessary exposure to drastic temperature fluctuations

i i ) Humidity or moisture control Moisture or humidity can adversely affect the stability of me dicines such as tablets capsules powders

45

Gelatin capsules become soft and swell on absorption of moisture The drug content of tablets may undergo surface hydrolysis The presence of moisture may encourage the growth of microbes It is therefore essential to control humidity

To reduce the effect of humidity the following suggestions may be followed -middot Open the windows to allow air circulation Use a fan to circulate fresh (outside) air middot In humid climate a dehumidifier is useful for preventing mo i s t u r e d a m a g e ( i n t h e absence of an air conditioner) middot For bulk containers of tabletscapsules do not keep the container open for a long time and replace the lid or closure immediately after taking out the required number of medicines for dispensing middot Do not allow the medicines to touch the floor or the walls The walls may be damp and may cause moisture absorption damaging the product

middot Calibrated thermometers and manometers can be used to detect temperature and humidity in the pharmacy

middot Periodici t y of checking the temperature should be fixed middot The climatic conditions should be recorded and documented middot Temperature charts should be available for ready reference

Documentation is one of the core activities for achieving and maintaining quality It is one of the most essential components of validation Temperatures in various areas

46

including refrigerators should be recorded at a predetermined periodicity usually daily at the hottest time of the day and such documents should be preserved i i i ) Storage conditions A number of storage conditions are mentioned on the labels of medicinal products These conditions have to be properly interpreted and appropriately complied with

According to the Drugs and Cosmetics Rules 1945

1 The term cool place means a place having a temperature between 10 C and 25 C

2 The term cold place means a place having a temperature not exceeding 8 C In case of storage conditions for specific products please refer to Schedule P The Drugs and Cosmetic Rules 1 9 4 5

The Indian Pharmacopoeia specifies the following storage conditions -

Wherever the condition for storage is not specified medicines may be stored under normal temperature In a country like India however where normal temperatures soar to h i gh temperatures it is recommended that medicines be stored in a cool place

Activity Prepare a list of the storage requirements mentioned on the label of about 20 products in your pharmacy and check if the temperature is maintained

47

25 Special Storage o f s u p p l i e s If the product has no special instructions normal storage conditions apply This means storage in dry clean w e l l -ventilated premises at temperatures of +15 C to +25 C or depending on the climate up to +30 C (WHO1990) Storage instructions are product specific Different brands of the same generic drug may have different storage requirements as they may have different packaging or formulations It is essential to follow the product manufacturers storage instructions to the maximum extent possible Less stable medicines must be stored in specific conditions to maintain their quality or potency

The following products require special storage facilities

middot Products that must be kept frozen (usually vaccines and sera) middot Products sensitive to h eat an d r e q uir in g r e f r ig e r a tio n ( +2 C to +8 C) middot Products that have reduced shelf life at uncontrolled room temperature and need

mechanical ventilation or air conditioning middot Flammable products that require separate fireproof premises middot Products prone to theft o r m i s u s e

Products needing storage in a controlled environment -

The usable shelf life of the following products may be reduced if stored at uncontrolled humidity or at room temperature in hot climates -

middot Some injectables (eg adrenaline) Most injectable preparations are less stable than solid oral forms (tablets and capsules) Injectable preparations in solution are particularly unstable Many injections must be protected from light as well as heat

middot Intravenous fluids (particularly if packed in p lastic containers) middot Some suppositories pessaries creams and ointments These products may melt at

temperatures greater than 30 C Once this happens it is not advisable to use them because the active ingredient in the formula may get unevenly distributed

middot Products containing rubber latex cellulose or some plastics Condoms most sterile disposable medical devices and surgical products such as syringes needles and catheters require protection from excessive humidity and strong light and heat Any o f these conditions may make products brittle stained amp unusable Sterility cannot be assumed if packaging is damaged

In hot climates these products should be stored in the coolest place possible preferably with air conditioning or air circulation fans

48

Products needing freezing or refrigeration-middot Vaccines blood products and many other medicines lose potency if kept even for a

brief period at temperatures outside the recommended range For these products the cold chain must be maintained at every stage of the distribution system

middot Freezing is as damaging as high temperatures for some products including injectable contraceptives ergometrine insulin adrenaline and the DPT DT TT and Hepatitis B vaccines Such products therefore sho uld not be allowed to freeze (not be kept in the freezer compartment)

middot Short periods at room temperature (during transportation or local distribution for instance) may be acceptable for many products (such as ergometrine a n d i n s u l i n ) e v e n t h o u g h s u c h e x posure can to some extent reduce shelf life Other items such as vaccines should always be transported in cold boxes

Storage of insulin injections-

middot Insulin should always be stored in a refrigerator at the recommended temperature of 2 -8 C

middot Insulin should not be kept in the freezer compartment of the refrigerator middot Insulin should ideally be stored horizontally middot It should not be exposed to sunlight or excessive heat middot Insulin suspensions should not be used if the suspension cannot be properly

resuspended due to cake or clump formationbull

Controlled drugs -Narcotics (for example Pethidine injection morphine preparations) and other specified drugs that may be abused are governed by special legislation and regulations The following security measures are suggested in the pharmacy -middot A safe or reinforced double locked cabinet fitted with a light (preferably with a red

bulb) that comes on when the door is opened

49

middot A special register recording details of each receipt or issue with 2 signatures physi cal counting of medicines after each entry and signatures at handover takeover

middot Independent audit (by supervisors and drug inspectors)

Products prone to theft abuse or misuse -

Some medicinesproducts are particularly prone to theft abuse or misuse These include expensive medicines (eg insulin) certain antibiotics and products prone to abuse or misuse like psychotropics etc

Such medicinesproducts should be stored adequately They require stricter record keeping and more frequent stock taki ng than others Periodic audits should be carried out to check for consumption against actual recorded use (registers prescription records stock records etc) to expose any theft or misuse bull26 Storage and stability of medicines Medicines are not stab le indefinitely They are stable for a specific period of time sometimes for a brief period Poor storage conditions accelerate the drug degradation (decomposition) Temperature light and moisture are the most important contributing factors for drug instability It is important to identify and be aware of the potential for instability There is a need to comply with storage requirements to ensure quality medicines for patients It is also important to offer advice to patients too about appropriate storage o f medicines at home The dispensing label should state the storage condition required and be backed up by a verbal reminder especially where special storage is required bull

50

In case stability and storage problems are seen with formulations they should be reported immediately to the representative of the manufacturer and taken out of circulation till the stability problems have been resolved

The pharmacist can easily detect stability problems when products show change in appearance color odor settling of the product contents breaking of emulsions melting of creams oozing of contents from the containers and any such physical changes

3 STOCK CONTROL AND EXPIRY MONITORING 3 1 S t o c k C o n t r o l For economic reasons pharmacists do not like to have stock on their shelves for long periods of time The aim should always be to keep stock at a level that will just meet demand Normally most manufactured medicines have a long shelf life Even then it is essential that there is efficient stock rot ation so that the older stock is used first It is also a good practice to check the expiry date as an integral part of the dispensing process When short shelf life products are involved stock levels may have to be modified to prevent medicines regularl y expiring on the shelves

32 Stock rotation and expiry monitoring In order to avoid accumulation of expired and obsolete stock medicines should be stored and issued according to the following guidelines -middot The stock control system must record the ex p i r y d a t e a n d t h e d a t e o f r e c e i p t middot Stock must be stored so that earliest expiring batches are picked and issued first middot The First In First Out (FIFO) system - In this system the stock which is received

first is sold first This system however may not be useful for pharmacies because most of the stocks carry an expiry date For pharmacies the FEFO system is more practical

51

middot The First Expiry First Out (FEFO) system - In this system the stock having an earlier expiry is sold first The stock with longer shelf life should be placed farthest to the back (or at the bottom in case o f sta c k e d b oxe s) T h is is pa r tic u la r ly impor ta n t with products that have short shelf lives such as vaccines some vitamins antibiotics etc and reduces losses due to expiry

middot E x p i r y dates should be noted on the stock record upon receipt Stock nearing expiry should not be accepted unless it can be used before expiry

Computerization and expiry monitoring In the pharmacy computerization facilitates both checking stocks and expiry mo nitoring and helps-bullbullKeeping a check on products nearing expiry bullbullKeeping a check on non- moving and slow moving products bullbullTo facilitate the removal of medicines nearing expiry from shelves in time to send them back to the wholesaler or supplier

Periodic checking for expiry The expiry date for medicinal products is a critical aspect in pharmaceutical dispensing and due importance should be given to it Periodic checking for expiry of medicines will ensure that the patient will never receive products that have crossed their expiry date During periodical checking of expiry the personnel involved should remove medicines that are nearing expiry bullbullIn -house threshold periods should be set and followed for retrieval of such medicines from the shelves bullbullSuch medicines should be stored separately These should either be dispensed immediately (thus ensuring that they are used before the expiry date) o r t h e y s h o u l d b e returned to the suppliers bullbullA separate area should be designated (cupboard or shelf)marked[FROZEN ZONE] which is adequately marked EXPIRED GOODS- NOT FOR SALE to store all expired stocks FROZEN ZONE

52

Remember Expired medicines are a NATIONAL WASTE So stock only what you can sell Avoid expiries save precious medicines for the nation

Treatment and disposing of expired medicines bullbullProcedures need to be in place for the treatment of expired medicines bullbullThe expired medicines need to be collected and be sent back to the supplier or company for appropriate disposal bullbullRecords must be maintained for expired medicines and how they are disposed off bullbullIn case of medicines that are not returnable to suppliers procedures for disposal need to be followed by the pharmacy in conjunction with the FDA The following procedure can be followed if medicines cannot be returned to suppliers ( T h e b a s i c p h i l o s o p h y of appropriate disposal is to prevent their re- circulation and use) bullbullC u t t h e c o n t ainer in such a manner that the label is also cut In case of tablets and c a p s u l e s d e s t r o y them by disposing them in a bucket of water bullbullUse landfill procedures (deep burial into the ground as per stipulations of Medical Waste Disposal Act prevalent in the respective state) bullbullPour the liquids into the sink and wash away with sufficient quantity of water bullbullKeep a record of such disposal with full details of medicines destroyed Although these measures are usually adopted care has to be taken with such tr e a t m e n t a s studies have shown that flushing of medicines has resulted in tracessmall quantities of medicines being found in waterways and groundwater having potential health and environmental effects

4 O T H E R A S P E C T S 41 Design of storage areas The following important factors need to be considered in design of storage areas -middot The retail outlets in hot areas in summers should be air-conditioned Similarly in

a r e a s o f e x t r e m e c o l d t h e p r e m i s e s w o u l d r e q u i r e w a r m i n g e s p e c i a l l y i n w i n t e r s t o maintain cool temperatures The placement of air -conditioners and heating devices should be such that medicines are not directly exposed to the cold or heat

middot Due consideration should be given to storage requirements of formulations while designing shelves and cupboards in retail outlets Sufficient shelf height should be provided so that all liquid products can be stored vertically As far as possible the shelves should be covered with glass panels to protect medicines from dust and p r e v e n t r a p i d f l u c t u a t i o n s i n temperature

middot Medicines should be stored according to the storage instructions on the labels bullIt is ideal to have a door at the pharmacy entrance to prevent dust from coming in as well as reduceprevent cooled air from going out This may not however be considered feasiblepracticable by many pharmacy owners for fear that clients may not enter the pharmacy because the door may act as a barrier An air curtain is a good alternative to a door

middot There should be minimal direct sunlight falling on the products Particular consideration should be given to premises directly facing the sun

middot bullThe arrangement of lighting in the interior of the premises should also be in a manner that the lights are not focused on the products It has been shown that light causes not only chemical damage but also can catalyze physical changes like moisture uptak e by the products Care should be taken to ensure that only diffused light falls on them

53

middot As far as possible provision should be made for a temperature and humidity indicator device in a pharmacy These devices are now easily available

middot Stability studies o f m e d i c i n e s p a c k e d i n b l i s t e r s h a v e r e v e a l e d t h a t i f t h e s e a r e exposed to light they tend to absorb moisture It is therefore necessary to store them in suitable cartons so that the blisters are not exposed to light Pharmacists should do this even if the manufacturer has not provided cartons

middot Light and temperature sensitive products should not be stored on counters where the light is intense or direct and there is no protection from temperature and humidity

42 Cleaning and maintenance i) Cleaning of storage areas

The storage areas of the pharmacy should be cleaned periodically and cleanliness should be maintained at all times The Standard Operating Procedure for cleaning should be designed and followed accordingly Schedules for cleanups should be laid down and adequate cleaning equipment should be made available

Tips for maintaining cleanliness middot Provide clean pieces of cloth for wiping at various locations in the pharmacy

Replace with clean cloth at regular intervals middot Keep separate pieces of cloth for floors shelves and medicines middot Use a disinfectant andor soap solution to clean floors middot Ensure removal of dust and prevent accumulation of dirt middot Ensure removal of cobwebs middot Use a vacuum cleaner for cleaning areas not easily reachable middot T a k e c a r e t h at breakages are handled and cleared effectively middot Observe the factors leading to waste generation in the pharmacy and take appropriate

measures to tackle the problem middot Record all cleaning procedures performed and maintain all the documents required

For ex a m p l e -bullbullThe floor of the pharmacy may be swept with a broom and swabbed with soap water every morning bullbullThe floor may be swabbed with a disinfectant every week bullbullThe entire premises including shelves and cupboards may be cleaned with a cloth (to remove dust and to check for medicines approaching expiry date or expired medicines) every three months bullbullAll the steps followed should be r e c o r d e d

The floor shelves drawers have to be cleaned and a check should be kept on dust cobwebs spillages due to breakage etc It is therefore essential to have SOPs for cleaning laying down cleaning frequencies allotting responsibilities and maintaining a daily record in the logbook to document all these activities

54

While cleaning dust settled on dosage forms like bottles tubes etc should be removed Before dispensing the products should also be wiped to remove any dust settled during storage

For refrigerators bullbullDefrosting and cleaning should be done at regular intervals bullbullSwitch off the refrigerator while cleaning bullbullCleaning should be done quickly and stocks put back immediately

i i ) Pest control Pests are a serious problem in India where insects reptiles and rodents (eg cockroaches l i z a r d s r a t s s i l v e r f i s h (Deemak - in Hindi ) etc) may find access to the pharmacy storage areas Insects like ants and borer ants may often attack wood in the pharmacy causing d am ag e to shelves cupboardsPest c ontr o l in a p h a r m a c y c a n b e a d i f f i c u l t t a s k b u t t o avoid possible contamination and physical damage to stock it is necessary to keep pests out of the pharmacy premisesPest control measures should be implemented with proper p r e c a u t i o n s t a k i n g u t m o s t c a r e t o a v o i d contamination of medicines

55

Th e following pest control measures c a n be ta ke n f r om tim e to tim e -bullbullRat bait and traps can be placed at various locations bullbullInsecticutors can be used on a permanent basis bullbullInsecticidal sprays and repellants can be used from time to time

i i i ) Fire precautions

Combustible trash such as cartons boxes and other packing waste must not be allowed to accumulate in the store Waste should be deposited in appropriate waste bins and be d i s p o s e d o f f o n a d a i l y b a s i s

F i re detection and fire fighting equipment must be maintained and regularly inspected The pharmacy personnel should receive adequate training in fire fighting techniques and emergency actionFire prevention measures should include a prominently displayed ldquoNoSmokingrdquo sign careful handling and disposal of combustible waste materials and checking of electrical connections at regular intervals

iv) Security middot Doors shutters of the pharmacy should be strong and be fitted with secure locks middot Counters should be designed so that unauthorized personnelclients do not have

access to areas where prescription medicines are stored Access to such areas should be restricted to the pharmacy staff

middot All the pharmacy staff handling supplies should be accountable for their ac t i o n s

56

middot bullSpecial care must be taken in case of Schedule X and manufactured drugs (under NDPS Act) Such medicines should be kept under lock and key and the key should be kept with the Chief Pharmacist or i n h i s a b s e n c e t h e s e n i o r p h a r m a c i s t

v) Breakagespillage and damaged product Products that have been damagedspoiled during storage and handling spillages and broken glassware should be disposed off according to procedures laid down by the pharmacy Broken and damaged products s h o u l d b e p l a c e d i n a segregated area to be returned to the supplier

vi) Inspection Senior staff should inspect all pharmacy areas regularly The shelves and drawers should b e c h e c k e d d a i l y f o r signs of pests and dust Ceiling and walls should be checked for dirt and cobwebs Stock should be checked on a regular basis for deterioration due to climatic conditions

43 Product recalls Products found to be defective should be quickly recalled (withdrawn from the market) The instructions are generally issued either by the manufacturer or the regulatory agency The level of recall is determined by both the degree of risk and the extent of distribution of the product and in India is mainly directed at the distribution chain

On receiving the details of the defective substandard spurious batchbatches of a medicine to be recalled from the manufacturer or the stockist or the FDA the pharmacy should immediately check if the particular b a t c h i s i n s t o c k a n d i f s o s u s p e n d i t s s a l e immediately

Similarly if the regulatory authority in the country bans a particular medicine or FDC the pharmacy should immediately check and remove all the different brands of that particular medicine under consideration

The details of medicines and their batches to be recalled should be available in the q u a r a n t i n e a r e a w h e r e stocks are received and checked This is to ensure that such medicines do not come into the pharmacy

middot The pharmacy should develop SOPs for recall of medicines middot The pharmacy staff should be immediately informed about such medicines and

the details should be displayed in writing in a prominent place in the pharmacy middot Rapid action helps avoid unnecessary exposure to such medicines once the

problem has been d e t e c t e d middot The progress of the recall procedure in the pharmacy should be monitored every

few days to ensure complete compliance middot All stocks of the recalled products should be stored separately from the saleable

stock These can be stored in the expiry cupboard segregated from the expired goods and be appropriately labeled ldquoRecal l e d G o o d s - Not for Salerdquo

The supplier should be notified and asked to replace defective products middot All the details of the procedures followed should be duly recorded in a Recall

Register maintained specially for the purpose The register should include d etails such as -middot Date of the recall middot Nam e of the product

57

bullbull

middot Details of the product (name of manufacturer batch number expiry date) middot Nu m b er of units purchased sold a n d sto c k in ha nd middot Reason for recall middot Nam e of the supplier to whom produc ts w e r e returned along with the date and quantity middot Name and signature of the designated personnel carrying out the recall procedure and recording details middot Name and signature of the chief pharmacist verifying the recall procedures and recording details 4 4 Returned medicines

Medicines may be returned to the pharmacy by clients due to the following reasons -bull

bullbull Unused medicines bullbull Course not completed bullbull Therapy changed by doctor bullbull Side effects experienced by patient bull

bullbull DamagedDefective medicines bullbull Missing or defaced label bullbull Missing tablets in a stripblister bullbull Leakage in bottles bullbull Leakage in strips bull

bullbull Expired medicines

Appropriate SOPs should be framed and followed for their acceptancerefusal and disposal middot bull For unused medicines returned by clients the p harmacy personnel should verify

that these were purchased from their pharmacy They should then be checked for integrity of the packing the dosage form and the expiry date and verified with the client whether they were stored in appropriate conditions This again is at the discretion of each pharmacy

middot The damageddefective medicines returned to the pharmacy should be taken back and stored separately Existing stock of the same product should be checked for similar defects

middot Expired medicines should be accepted from clients at the discretion of the pharmacist and be immediately shifted to the expired goods cupboard These can be stored segregated from the pharmacys own expired goods and be appropriately labelled ldquoExpired Goods returned by clients- Not For Salerdquo

It is advisable not to accept returned medicines requiring cold chain storage (refrigeration) because it cannot be ensured that the cold chain was maintained when the medicines were in the hands of the patientclient middot Appropriate adjustments in t he stocks should be made for medicines

returnedexchanged to update the inventory middot The medicines should then be returned to the respective shelves middot A lsquoReturned Goodsrsquo register needs to be maintained to record all details of returned

medicines

R egister should include such details as-

58

middot N a m e o f t h e p a t i e n t middot Nam e of the product and quantity r e tu r n e d middot Product details such as the batch number and expiry date middot Condition in which received middot Reason for returning products middot Compensatory measures taken wi t h r e s p e c t t o c l i e n t middot Action taken with respect to product middot Name and signature of the personnel accepting the returned medicines and recording details middot Name and signature of the chief pharmacist verifying the recorded details

What the pharmacist would have learnt from this module The storage of medicines is a critical factor in the distribution cycle bullbull Stocks received by the pharmacy should be quarantined in a separate area and necessary checks s h o u ld be performed to ascertain the qua lity a nd quantity of stocks received bullbull Whatever pattern and means of storage used the products should be stored so as to maintain their potency and integrity bullbull Storage conditions should be monitored and maintained on a regular basis bullbull Optimum stock levels should be maintained and regularly monitored for expiry bullbull The design of storage areas should facilitate appropriate storage of medicines bullbull Cleanliness should be maintained in the pharmacy bullbull Adequate measures should be taken in case of returned medicines and recalled products

Optimum storage of medicines is mandatory whether at the distribution stage at the pharmacy or ultimately within the homes of patients The pharmacist has an important r o l e t o p l a y i n t h e s t o r a g e o f m e d i c i n e s i n m a i n t a i n i n g d r u g p o t ency and efficacy and thus facilitating optimum therapeutic benefits Good Pharmacy Practice - IPA -CDSCO - WHO Appendix I Quality Assurance Templates of letters for use if found not of Standard Quality [Frozen and expired goods ]

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated To Name of the Supplier with address

Sub Not of Standard Quality GoMP-Supply of Drugs and medicines-(Codename) Return of Stocks to the Suppliers-reg(New drug policy 2009) Previous letterinvoice ref Sl No Drug Code Drug name

Manufacturing date Expiry date

Supplier address

B a t c h n o

The above items of PO nodated was drawn by the Drug Inspector (Place) on (______________date) as a statutory sampling and declared ldquoNot of Standard

59

Qualityrdquo on -(______________date) by the Government Analyst for the following reasons

- ldquoThe product sample do not confirm to IP specification for (Drug codename with respect to the content of drugrdquo

- ldquoThe product has already been blacklisted by TNMSC on -(______________date) for the failure of (quantity) of batches of drug codenamerdquo

As per the clause of the te nde r d oc um e nt ldquo I f the sa mple s d o not c onf o r m to statutory standardsthe tenderer will be liable for relevant action under the existing laws and the entire stock in such batch should be taken back by the tenderer within a period of 30 days o f t h e r e c e i p t o f t h e l e t t e r f r o m t h e v e n u e

The stock shall be taken back at the expenses of the tendererthe Procurement Authority have the right to destroy such Not of Standard Quality if the tenderer does not take back the goods within the stipulated time

The Procuring Authority will arrange to destroy the Not of Standard Quality drugs within 90 days after the expiry of 30 days mentioned above without further notice and shall also collect demurrage charges calculated at the rate of 2 per week on the value of the drugs rejected till such destructionrdquo

Hence we regret to inform you that you will have to take back the stocks available of the abovesaid batch at your own cost from the drug stores where you have supplied the above batch

Kindly acknowledge the receipt of this reference at once

P r o c u r e m e n t A u t h o r i t y Seal and Stamp

Copy to Ref No dated

1 ) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated13082010

To

Sub Frozen Drugs-ordered to return to the Suppliers-reg(New drug policy 2009) Previous letterinvoice ref

The following products which were earlier frozen have now been ordered to return to suppliers directly with permission from the State drug Authority In this regard the suppliers have been instructed to take back their failed batch from the drug store of the stores Hence you are now instructed to return the following failed batches to the suppliers by obtaining proper authorization letter and acknowledgements from them

60

Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

Kindly acknowledge the receipt of this reference at once

Procurement Authority Seal and Stamp

Copy to

Ref No dated 2) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated14092010

To

Sub Frozen Drugs-ordered to return to the Suppliers- for issue of gate pass after verification reg(New drug policy 2009) Previous letterinvoice ref

The following products which were earlier frozen have now been released Hence they may be issued Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

Kindly acknowledge the receipt of this reference at once

Procurement Authority Seal and Stamp

Copy to

61

Ref No dated 3) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated

To

Sub Stop instruction-reg(New drug policy 2009) Previous letterinvoice ref

Until further instructions stop issue all the batches of the following item Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

You must intimate the available stock in the stores of the said batch Number to the Procurement Authority immediately Also retrieve quantity if already issued

Procurement Authority Seal and Stamp

Copy to

Ref No dated 4) HOD Procurement Office of

62

Appendix II Material handling in drug stores

Rack approx rates and dimensions

S No

Item Description UOM Approx Rate

1 MEDIUM DUTY RACK SIZE 2900 H X 3090 W X 800 D IN MM (AS PER SPECIFICATION)

Each 2499800

2 MEDIUM DUTY RACK ADD ON UNIT FOR SIZE OF SR NO2

Each 2243100

To locate a Box no 3 Rack no 14 in row3

SAMPLE OF RACK no Bin numbering -------------- S a y R K 1 4 R o w 3 B o x 1 6

SAMPLE LAYOUT of RACKS in a Drug Stores

63

Sample of another warehouse of distribution warehouse system

64

65

Slotted Angle racks with bin cards

66

Plastic Pallets

Plastic pallets ar e l i g h t w e i g h t l o w- c ost and exceed industry standards for strength and durability

NOTE A pallet has bottom deckboards (see sketch) A skid does not have bottom

67

deckboards

Battery Operated Stacker

Electric Stacker Ehh (Manual Push Type) - Manual drive - Lifting electrically with Battery 12 V 88 Ah - For loading and un-loading of trucks - Battery and loading device built - in - Battery charge gauge and charging current gauge Simple and Easy Operation - Lifting and Lowering electrically direct on steering arm - Pulling and pushing through steering arm - Electrically operated relief valve on hydraulic aggregate Safe Operation - Emergency Off Switch - Constant lowering speed - Protection through lowering brake valve - Overload protection through overload brake valve - Load chains covered preventing pinching threat - Electrically interlocking during loading process - Secured battery compartment opens upwardly - Stable buffering of the steering arm in upright position - In accordance with EWG Guidelines 89 240 - In accordance with VBG 12b Prevention of Accidents

Pallet Truck [ Top ]

68

----------------------------------------------------------------------------------------------------------------------------

For Transport Of All Goods On Pallets Safe and Easy Operation - through single hand operation Lifting moving

lowering with steering handle - neutral position of the hydraulic possible - overload pressure relief valve Long Service Life - robust co n s t r u c t i o n

- special hardened axles - hardened chromium plated ram - maintenance free Easy Maneuverability - through rubber steering rollers - nylon fork rollers

A h a n d t r o l l e y

69

Trolley with plastic bins for several items del ivery

70

Digital Weighing balances

Balances amp Scales EF Seriers Precision Electronic Balance

71

1

Ice lined Refrigerators

600 litres refrigrator

72

Walk in cooler

vacuum cleaner

73

6

bull S y s t e m

7

bull System of Tendering at a Glance

8

DIRECTORATE OF HEALTH SERVICES MADH YA PRADESH

No Q E q p O c t 7 7 Bhopal the 2 6 th October 1977

(E x t r a c t e d f r o m t h e G O and reproduced f o r 2 0 1 0 -11 to have clearity on process of

procurement )

To

The Deans

The Divisional Joint Directors of Health

Th e J o int Director of Ayurveda

The Administrative officer ESISIndore

The Superintendents of Medical College Hospitals

The Superintendents of Special Hospitals

The Civil Surgeons

The District Family Welfare cum Health Officers

The Principals RHFWTC

MADHYA PRADESH

Subject -Rules Orders for management of stores

The Government of Madhya Pradesh in the department of Public Health and family Welfare have by their order No 305847795-2877MedIII dated the 13 th

October 1977 issued Rules for the management of STORES These come int o force from the day they are received by the officer-i n- charge of an institution

It is desired that these Rules be followed strictly both in lsquoletter and spiritrsquo and no explanations would be accepted for non-compliance

Sufficient number of printed cop ie s a r e be ing se n t to you f o r d istr ibution a m ongst your subordinate staff concerned with the subject

A C Gaur For Director Medical Services

Madhya Pradesh

9

ACQUISITION OF STORES

The word Stores used hereunder applies generally to all articles expendable as well as dead stock of the nature of plant machinery instruments furniture fixtures medicines linen etc etc

Any authority which is competent to incur contingent expenditure may sanction the purchase of stores required (sub ject to his d e le ga tion of f ina nc ia l pow e r s) pr o vide d the following rules are observed-

(a) A Purchase Committee comprising of atleast three Gazetted Officers is formed for approving quantity and quality of stores required

( b ) An enquiry for the articles purch ased should be sent out to various manufacturers and dealers if the total of the order is for Rs 15000 or less In case the purchase order is likely to exceed Rs 15000 ldquoopen tendersrdquo be called through news paper publicity ( f igur e s p e r ta in to 1 977)

(c) Stores s h o u l d n o t b e p u r c h a s e d i n s m a l l q u a n t i t i e s and often if such store is not perishable

( d ) Requirement of the whole year to be worked out a nd n o stor e sh ould b e p ur c h a se d in e x c e ss o f the requirement

(e) P u r c h a s e s h o u l d b e m a d e i n t h e m o s t e c o n o m i c a l manner but q ua lity ne e d not be sa c r if ic e d in the interest of the economy

(f) The details regarding the quality desired and expected purchase quantity should be mentioned in t h e e n q u i r y

(g) Purchase order should not be split up to avoid the ne c e ssity o f obta ining th e sa nc tio n o f t h e h i g h e r authority

( h ) The date and time of opening of the tender should also be published and in case the tenderers desire to be p r e se nt o n th e o c c a sio n th e y should b e a llo w e d t o d o s o

( i ) Mere initialing on the covers of the tenders is not sufficient All the Purchase committee members s h o u l d s i g n o n e a c h a n d e v e r y p a g e o f t e n d e r q u o t i n g t h e r a t e s A n y r a t e s w h i c h h a v e b e e n overwritten by the tenderer should not be c o n s i d e r e d u n l e s s t h e y b e a r t h e t e n d e r e r rsquo s s i g n a t u r e and subsequently signed by a member o f t h e Purchase committee

( j ) A list of tenders opened should be made out and t a l l i e d w i t h t h e o n e o f t h o s e r e c e i v e d i n t h e o f f i c e Such a list should be signed by all the members of the Purchase committee

( k ) A comparative statement is then made and lowest t e n d er i s a c c e p t e d s u b j e c t t o q u a l i t y o f f e r e d b e i n g

10

satisfactory Samples of non perishable articles should be preserved safely under lock and key for comparison till the contract for supply is in force

( l ) R e a s o n s for rejecting the lowest tender and accepting the h i g h e r o n e s h o u l d a l w a y s b e r e c o r d e d in writing by the Purchase Committee

(m) No reason for rejecting the lowest tender need to be communicated to the tenderer

( n ) Every purchase order should clearly mention that the articles ordered shall be accepted subject to t h e approval of the Purchase Committee

( o ) Rules regarding deposition of earnest money and security money should be observed

( p ) For emergent purchases in public interest when there is no time to observe Store Purchase Rules purchases should be made up to Rs 2 5000 (refers to year -1 9 7 7 ) a t a t i m e A s f a r a s p o s s i b l e t h i s practice should be avoided

II PLACING OF ORDERS (a) For medicines and such other articles which the Medical Stores Depot Bombay

supplies order be placed with them at a specified time ( b ) For articles not on the Bombay Stores Depot Bombay lsquolimitedrsquo or lsquoopenrsquo

tenders be invited as the case may require It would be preferable to place orders on the manufactures or their authorized distributors

(c) For placing the orders on PSUrsquos Laghu Udyog Nigam or Organisations approved by the State government no tender needs to be invited

( d ) Price preference upto 10 is available to Small Scale Industries of this State only(not applicable as per New drug policy 2010 -1 1 )

III RECEIPT OF STORES All materials received should be examined counted measured or weighed as the

case may be when the delivery is taken The stores thus verified be may be immediately entered in the stock register Book under proper headings and this fact should be recorded on the body of the bill mentioning the page number of the Stock Book It should also be mentioned whether the quality and the quantity are correct as per the requirement Soon after the receipt each item be stamped with the initials of the institution

IV CUSTODY

(a)The head of the institution should ensure suitable accommodation for keeping the stores with a view to prevent losses through theft accident fraud or otherwise

(b) Separate Stock Accounts should be kept of-( i ) D e a d S t o c k-such as plantmachineryfurniture equipmentinstruments

etc (ii) Expendible items such as medicineslinenrubber goods etc (iii) Perishable articles

(c ) all recepts and issues in the stores stock registers should be on the authorityand under the signature of a respon sible officer deputed for the purpose

11

V ISSUE OF STORES (a) When materials are issued from stock the officer -i n ndashcharge should ensure that the indent is in proper proforma (Annexure A) and the person taking delivery is an authorized one (b) The issue vouchers (Annexure B) for articles should be prepared in triplicate by one single stroke of pen The first copy will remain with the records of the stores The second and third copies will go to supplies The second copy will be retained by the person receiving the supplies and the third copy will be returned by the receiver to the stores after making entries of hisher stock book page number etc against each item ( C ) E v e r y t i m e i s s u e b e r e c o r d e d i n t h e s t o c k b o o k o f t h e s t o r e s w i t h s i g n a t u r e s o f t h e O f f i ce r i n -charge

(d) Every issue made from the Central Stores to other institution should show cost of article preparation of Annual Stores Account at a later date

VI Maintenance of Stock Books (a) Stock book should be kept under the charge of a responsible person and should be

saved from loss and destruction ( b ) While making new entries in the main Stores Stock book cost of each item

should be entered though this need not be done in the case of registers in Wards Operation Theatre Out door etc

(c) There should b e n o o v e r-writing or interpolation or smudging of figures Any f i g u r e i f i t i s t o b e c o r r e c t e d s h o u l d b e c l e a n l y c u t a c r o s s a n d t h e n e w f i g u r e should be written by its side or below it under proper attestation

( d ) Stock books should always have a page count(each page be numbered) A certificate showing the number of pages be given on the first and the last page under the signatures of a Gazetted Officer

(e) Receipts issues and balances should be worked out for every item and attested regularly by the Offic er-i n -Charge of the Stores

(f) In the receipt column details regarding the size quality and any special features if t h e r e b e s h o u l d b e r e c o r d e d e g i n t h e c a s e o f A l m i r a h i t s s i z e a n d w h e t h e r i t i s of Steel or Wood

(g) In the Stock-book of library Edition and the ye a r o f p ublic a tion of th e book should always be mentioned

( h ) In case of medicines having an expiry date a list of such medicines be made out and should be checked every week Two months prior to the date of expiry if the s t o c k i s s t i l l f o u n d s u f f i c iently high intimation should be given to Directorate of Health

(i) N o r e m o v a l o f d e a d s t o c k s h o u l d b e m a d e f r o m t h e s t o c k ndash B o o k u n l e s s s o a u t h o r i z e d b y t h e c o m p e t e n t A u t h o r i t y

(j) While making a new Stock book and transferring the stocks therein it should ensured that the page number of the old stock book is shown in the new stock b o o k a n d s i m i l a r l y p a g e n u m b e r o f t h e n e w s t o c k b o o k i s m e n t i o n e d i n t h e o l d one This has to be done to facilitate cross checking whenever desired

( k ) T h e r e h a v e t o b e d i f f e r e n t s e t s o f proforma for dead stocks and for expendable items

Annexure ldquoCrdquo is for former and Annexure ldquoDrdquo for the latter varieties

12

VII PROCEDURE OF INDENTING FOR WARD amp OTHER SECTIONS OF THE INSTITUTION

(a) There has to be an Indent Book with every such section wh ich receives and issues medicinesequipment

( b ) The indent shall be prepared by the nurse Compounded -i n -c ha r g e of th e WardSection in te single copy on the Performa (Annexure A)

(c) The indent so prepared will be signed by the medical officer resident ndash i n c h arge or in his absence by a doctor senior to him but associated with the ward section

( d ) The indent shall then be signed by the head of the institution (Superintendent or the Civil Surgeon as the c a se ma y be ) o r b y his A ssista n t if th e la tte r is so authorized in writing

(e) The indent book is then presented to the main Store for effecting issue (f) The Store will then prepare issue vouchers (Annex B) in triplicate as directed

in Paragraph V (b) supra The supplies and the Indent Book are taken back by the Ward Section- i n - charge after signing the first copy of the issue voucher

(g) Te supplies after arriving in the WardSection shall be entered on the WardSection stock register which is prepared on a proforma (Annexure E) and page number of each entry be shown o n t h e 2 n d a n d 3r d copies of the Issue

voucher The 2 n d copy of the voucher is to be retained in a file in the wardsection but the 3r d c o p y s h o u l d b e r e t u r n e d t o t h e s t o r e b e f o r e s u b m i t t i n g a fresh indent The Store has to be maintain separate files of the 3 r d copies Wardsection-wise

VIIIHOW OFTEN TO INDENT

(a) A wardsection ndash i n -charge should work out an average weekly expenditure of each item and efforts be made to replenish the WardSection stocks every week

( b ) T h e M a i n s t o r e i n o r d e r t o a v o i d h e a v y rush of work should fix a day of issue for each major specialty T w o or th r e e minor spe c ia ltie s c a n be gr o upe d f o r one day

IX EMERGENT INDENT It is very likely for unforeseen reasons either the weekly indent of WardSection stock might get exhausted earlier or something which was not there in the lsquoweekly indentrsquo is required Under such circumstances an ldquoEmergent Indentrdquo could be made out in the usual manner but under the signature of the Unit-i n- chargeconsultant and it must be countersigned by the head of the institution (and not by his assistant) These supplies have also to be entered in the wardSection stock books like others

13

X HOW TO INDENT

(a) The ward Section -i n - c h a r g e s h o u l d e n s u r e t h a t t h e s t o c k s u n d e r t h e i r c h a r g e a r e not unnecessarily large and only a realistic quantity is indented once a week

( b ) The indent should not be made out in the names of the patients or by bed numbers The indent should be for the Wardsection as a whole

XI KEEPING OF RECORDS IN WARDS AND SECTIONS

(a) A set p r o f o r m a ( A n n e x u r e E ) s h o u l d b e u s e d i n t h e w a r d s e c t i o n f o r s h o w i n g u p receipts and issues Balance of expenditure for each item to be drawn out every morning by nursecompounder in charge before writing out the Indent or before restarting work The medica l O f f ic e r r e side nt in c ha r g e sh ould a tte st th e e ntr ie s after satisfying himself- by random checking at least once a week

( b ) To support the above mentioned expenditure the Bed head Tickets (treatment charts) are very important Each medicine prescribed should be legibly written indicating the total quantity prescribed if the medicine is to be deleted from treatment the fact should be mentioned as to how much of the drug was issued to the patient before switching on to another drug The suggestion is that a separate treatment card be maintained for each indoor patient ( Annexure ndash G) A summary s h o w i n g t h e t o t a l a m o u n t o f t h e p r o p r i e t a r y d r u g s c o n s u m e d b y t h e p a t i e n t d u r i n g is hospital stay be worked out and noted in the summary card

XII ACCOUNT ABILITY OF DRUGS BROUGHT BY THE PATIENT OR RECEIVED IN DONATION BY THE WARDSECTION _IN -C H A R G E

The drugs receoived from the non - governmental sources should be entered on the receipts side of the WardSection Sto c k b ook a n d issu e s to show n a s in th e o the r cases on the issues side

XII RSPONSIBILITY OF STORES AT VARIOUS LEVELS (a) The head of the institution shall be held responsible for non-observance of

rulesprocedures laid down by the Government ( b ) The Medical officerresident in charge of the stores and the store keeper shall be

held responsible for any irregularity found in the stores or for ignoring the ordered pattern of working It shall be the duty of the Medical officer Incharge of the Stores to occasionally check the WardSection Stock-b o o k s t o t a l l y t h e e n t r i e s made in the 3 r d copy of the Issue vouchers [as laid down under V (b)supra ]

(c) The Medical officerresident in charge of the WardSection shall be responsible for irregularities in indenting stocksfor maintaining stocks much in excess of the req uirement and for improper keeping of BED HEAD TICKETS (treatment chartsCards)

( d ) The NurseCompounder ndash i n -charge of the WardSection shall be responsible for shortages in stocks for putting up inflated indents and or for not taking into account medicines b rought by the patientson the WardSection stock-books Heshe shall also be held responsible for ensuring proper distribution of medicines to each and every patient under his her charge

XIV DISTRIBUTION OF MEDICINES FROM OUTDOOR DEPARTMENT (A) ( a ) T h e r e are proprietary and non -proprietary medicines (like mixtures ointments

and lotions) which are to be distributed gratis to patients 14

(b) The Outdoor incharge shall arrange to maintain a stock of common drugs (list of which shall be prepared by the Head of t he Institution) and arrange to replenish the stocks once a week as has been laid down for wards (c) No proprietary drugs shall be issued on the prescription of an intern ( d ) The Head of the institution shall make out a list of drugs which can be issued on

the prescription of a houseman from the Outdoor stock without the countersignature of any other authority

(e) The residents can prescribe any drug from Outdoor stock without the counter signature of any authority

(f) The Consultants can prescribe any drug to any ot h e r o u t e r p a t i e n t e v e n i f i t i s n o t s t o c k e d i n t h e o u t d o o r b u t t h i s s h a l l h a v e t o b e c o u n t e r s i g n e d b y t h e h e a d o f t h e institution for issue from The Main Store

(B) T h e p e r s o n i n c h a r g e o f t h e O u t d o o r m e d i c i n e s s t o c k s h a l l k e e p a r e c o r d o f t h e q u a n t i t y o f t he medicines issued to each patient and instead of writing the name and other details e may only put down the Registration number of the patient and the quantity issued

At the end of the day he must work out the total expenditure of eac item and draw it s balance

The Medical officer in charge of the Stores and the Head of the institution sould check these records at least once a week and affix is signature to confirm their inspection

(C ) No proprietary medicine shall be issued without a valid issue s l i p ( A n n e x u r e- F)

(a) For Housemen the slip would be of brown colour ( b ) For residentsDemonstrators it shall be of pink color (c) For consultants the issue slip should be white ( d ) All issue slips should be printed and pages serially numbered (e) T h e d o c t o r s t o w h o m s u c h i s s u e s l i p s w o u l d b e i s s u e d s h a l l b e h e l d

responsible for their sa f e ke e ping a n d th e y w ould e n su r e tha t th e se slip s would be printed and serially numbered

(f) The doctors prescription slips (for issue from hospitals) of proprietary drugs be prepared in du plicate with the help of carbon One copy should be given to patient for obtaining medicines from the Stores and the other would remain in the Doctors Prescription Slip book

(g) Every issue Slip should be signed and below the signatures a rubber s t a m p s h o w i ng name and designation be affixed The Store people would n o t h o n o u r s l i p u n l e s s t h e n a m e o f p r e s c r i b e r i s c l e a r a n d h i s a t t e s t e d signatures are available to stores

( h ) The Store Staff would file prescription slips of each doctor separately to facilitate the scrutiny at least once a month by the Head of the Institution Such a Scrutiny would reveal over prescribing of or injudicious use of drugs

(C) Proprietary medicines should not be issued for more than three days requirement at a time The only exceptions being cases for cancer pulmonary tuberculosis and leprosy In exceptional cases an officer not below the rank of a Consultant can prescribe for more than 3 days but after the countersignatures of the Head of the Institution

15

XV LOSS BREAKAGE DAMAGE ETC

(A) Any loss of public money departmental revenue of receipts stamps stores or other property held by or on behalf of the Government caused by defalcation or otherwise discovered in an office or institution should immediately be reported by the officer concerned to the head of department through his immediate superior as well as to the Accountant General if the loss exceeds Rs 20000(fig of 1977) (for Proforma see Annexure I)even when such loss has been made good by the party responsible for it Such reports must be submitted as soon as possible and soon after suspicion arises that there has been a loss they must not be delayed while detailed enquiries are made

When the matter has been fully investigated further and complete report should be submitted of the nature and extent of loss showing the errors or neglect rules by which such loss showing the errors or neglect of rules by which such loss was rendered possible and prospects of effecting such recovery

The s ubmission of such a repot does n o t d e b a r t h e l o c a l a u t h o r i t i e s t a k i n g f u r t h e r a c t i o n which may be deemed necessary like handing over the case to the police

Every Government servant should realize fully and clearly that he will be held personally responsible for any loss sustained by the government through fraud and negligence on is part and that will also be held personally responsible for any loss arising from fraud or negligence on the part of any other Government servant to extent to which it may be shown that he has contributed to loss by his own action or negligence

A s s o o n a s s h o r t a g e i n s t o c k o r l o s s i s d i s c o v e r e d a p a r t f r o m r e p o r t i n g t h e m a t t e r a responsible officer should be deputed to investigate the matter

W h e r e t h e r e i s n o l i k e l i h o o d o f a d e l i b e r a t e t h e f t b u t l o s s i s a result of neglect onlythe loss should be made good by the person on whose charge or custody the article lost remained

(B) As soon as damage or breakage of Government property is detected certain steps mentined under should be undertaken-

(a) A p r o m p t t h o ro u g h i n v e s t i g a t i o n i n t o t h e c a u s a t i o n o f b r e a k a g e o r d a m a g e s h o u l d be undertaken by the doctor-i n -charge of the WardSection or by the Head of the Institution

( b ) The investigating officer should draw conclusions as to whether the breakagedamage has been a result of-

(i) C a r e l e s s a n d n e g l i g e n t h a n d l i n g ( i i ) Unpredictable action of the patient for whom the equipment was

being used (iii) Accidental ( i v ) Manufacturing Defect

A report is then prepared in duplicate by person in charge of the article under question on the lsquobreakage and loss proformarsquo (See Annexure H)

16

These reports have to be signed by the investigating officer and are to be then submitted to competent authority for suitable action One copy which is returned is to be kept with the Stock Register In cases where the b r e a k a g e o r d a m a g e i s o f s u c h b i g g e r d e g r e e t h a t s atis factory repairs are not possible a n d if suc h b r e a k a ge o r da m a ge is o f su c h a de gr e e that satisfactory repairs are not possible and if such breakage or damage has been caused-

( i ) B y a G o v t s e r v a n t because of negligent or careless handling cost of the article should be recovered from him and credited to the treasury (ii)On account of reasons mentioned above that is un predictable action of the patient accidental or manufacturing defectthe article could be written offsubject to powers delegated to the concerned for such purpose

(C )Shortages detected during biannual physical verification of the Storeshave to be dealt in a similar manner

(D) it shall be at discretion of the competent authori ty (who is empowered to write off the loss) to reduce the amount of recovery upto 50 of the cost of article provided that before arriving at such a decisionhe has taken into account the following points (a) Normal life span of the article under questi on (b) Period for which it has been in use (c ) Condition of the article at the time of loss or damage and (d) Whether it was on account of careless or negligent act or not

XVI PROCEDURE FOR WRITING OFF STORES

(a) When any Stores become unserviceable otherwise than in ordinary course or by fair wear and tear their value should be treated as loss to the Government and in such cases cost should be recovered from the person responsible for his negligence

( b ) A s t r i c t w a t c h s h o u l d b e k e p t o n t h e m e d i c i n e s w h i ch bear an expiry date and if there is no likelihood of their being utilized locally intimation of the fact should be sent to Directorate of Health services and also to all o t h e r d i s t r i c t s s i m u l t a n e o u s l y s o t h a t t h e y c a n b e p u t t o u s e b e f o r e t h e expiry date In the event such a course is not followed and the Government i s p u t t o l o s s c o s t o f t h e m e d i c i n e i n q u e s t i o n s h a l l b e r e c o v e r e d f r o m t e defaulter

(c) For declaring articles as unserviceable a Committee of three members should be formed in each officeinstitution This Committee should examine each and every article brought before it and should record full reasons for condemning them and also say how the articles condemned have to be disposed of-whether by sale (by public auction) or otherwise

I f t he local Authority is not competent to write off the articles condemned by the Committee it should send the proposal to the higher authority for suitable a c t i o n

17

In Institutions where there is only one doctor a list of articles to be condemned should be p r e p a r e d a n d o r d e r s o n i t b e o b t a i n e d f r o m t h e inspecting authority during inspection

While preparing any list of articles for condemnation details regarding the date of purchase date of receipt period during which it remained in use usual life of the article and its purchase price should be noted against each item

( d ) The condemned articles should not be struck off the Stock Register till the competent authority sanctions its write ndashoff Details of Authority under which the article has been written off should be mentioned in stock register

XVII DISPOSAL OF WRITTEN OFF ARTICLES

Articles like linen should be torn into strips 10cm width so that they could be burnt or given to Government Jails for making carpets

Items like bed -pans bowlsurine po ts etc should be crushed and kept for auction

Brass utensils have also to be crushed to destroy their shape and could be either auctioned or after inviting rates from several dealers could be locally sold to highest bidder

In case when condemned ar ticles have to be sold by public auction they should be stored safely and the Government Auctioneer be intimated In case he expresses his inability to undertake the auction the officer should proceed with the auction departmentally The sale proceeds in either case should be credited to the Treasury as miscellaneous receipts under the Proper head of account

XVIII PHYSICAL VERIFICATION (a) The stocks held by officesinstitutions in various sections should be physically

verified twice a yearin the months o f April and October ( b ) Checking should be done by an officer other than te one who holds the charge of

Stores (c) Verification should be done in presence of officer holding the charge of Stores ( d ) All discrepancies found during the verification should be properly investigated

and accounted for

(j) Any excess detected during verification should be entered in the Stock book as Receipts with the remark ldquo Excess found on verificationrdquo

(ii)any shortage should be noted in issues column of lsquo Issuesrsquo described as lsquoshortage fou n d o n v e r i f i c a t i o n rsquo

XIX ANNUAL STORES ACCOUNT This account should be prepared according to the instruction issued from the department from time to time This should account for the outgoing financial year on the following lines -(a) Cost of the articles under various heads on the last day of the previous

year 18

( b ) Cost of the articles under the various Heads Received during the year (c) Cost of various articles written off during the year under review ( d ) Cost of the articles on the last day of the year or on the firs t d a y o f t h e

financial year following

19

Annexure A WardSection Indent Register No Issued on

Name of institution Page Folio No

Serial no Name of Article Quantity in Stock

Quantity required

Prepared by Approved by Recd by Note-Indenting Officer to sign and affix seal with name and

designation below the last item to avoid additions in one strokeno issues to be made by storesif Issue vouchers of

previous Indent has not been returned back by the WardSection

20

Annexure B Issue Voucher No (printed number)

Supplied to Wardsection Date

Indent no

Serial no Name of Article Quantity in Stock

Quantity required SB No

Stores-in MO Resident in Sign of charge charge WardSection

NurseCompounder Prepared by Recd Approved by by

Note-Indenting Officer to sign and affix seal with name and designation below the last item to avoid additions in one strokeno issues to be made by storesif Issue vouchers of previous Indent has not been

returned back 1st copy-Stores 2nd copy -Wardsection3rd copy-Tobe reurned to sores with Stock book entries

21

Annexure C

STOCK REGISTER FOR DEAD STOCKS

SERIAL NO DATE OF RECEIPT

Article with description

No of pieces Cost Details of

Bill Signature No Disposed

Date of disposal

Manner of Disposal

with Authority

Value realised Signature

1 2 3 4 5 6 7 8 9 10 11 12

P r e p a r e d B y C h e c k e d b y A p p r o v e d b y

Date Designation Name of Institution

22

Annexure D

STOCK REGISTER FOR EXPENDABLE ITEMS Name of article

Date

From where

received with cost

Quantity Signature To whom issued Quantity Balance Signature

1 2 3 4 5 6 7 8

23

Annexure E

Receipt amp Issue Register for WARDSSECTIONS (one or more pages as per requiremnt for each medicine)

NAME OF MEDICINE RECEIPT ISSUE

DATE Quantity In Stock

Date of

Issue

Issued toMention Bed no amp

quantity (in bracket) (For

Outdoor cases give Regd No)

Balance Signature

24

Annexure -F

OUTDOOR FREE MEDICINE SLIP In Duplicate

Name of Patient Registered No Date

Sr no Name of Medicine Quantity

Seal amp sign of doctor

25

Annexure-G

TREATMENT CARD

WARD NO

NAME OF PATIENT BED NO DATE amp TIME OF ADMISSION DATE amp TIME OF DISCHARGE

DATE MEDICINES PRESCRIBED SIGNATURE

26

ANNEXURE -H

PROFORMA FOR BREAKAGE amp LOSS

NAME OF OFFICEINSTITUTION DATE PLACE

SRNO NAME amp

DESCRIPTION OF ARTICLE

COST DATE OF PURCHASE

REASON CAUSE OF BREAKAGE

RECOMMENDATION OF INVESTIGATING AUTHORITY

Signature

Orders of the Competent Authority

Signature

27

Annexure ndash I Loss- Procedure for Reporting

1 The exact nature of the defalcation 2 The full extent of loss 3 The actual period covered by the defalcation 4 The defects in the negle c t o f r u le s by w hic h the loss was rendered possible

and circumstances which facilitated the defalcation 5 The names of the officials held personally or technically directly or

indirectly and wholly or partially responsible for the irregularity c o m m i t t e d i n t h e c a s e

6 Whether the c a s e a s b e e n J u d i c i a l l y t r i e d i n a c o u r t o r n o t i f s o c o p i e s ( i n duplicate) of the Judgment may please be furnished Copy of police report may also be furnished

7 The remedial measures adopted as safeguards against the losses hereafter 8 The prospects of re covery of the loss and he action taken to effect

recovery together with the amount recovered 9 Head of Account to which the Loss is debitable may be informed

Signature of Head of Office with seal

NoteA copy of this report is to be sent to AGMPThis is as per M P Finance Code Vol I

28

STORAGE AND STOCK MANAGEMENT

29

Foreword

The New Drug Policy 2009 is being implemented in the State of Madhya Pradesh

In order to have a proper procedure for Storage maintenance and expiry management of the drugs it is necessary to follow Good Storage Practices with Standard Modules for pharmacistStore keepers

Proper guidelines on Storage Practices can lead to better Stores and inventory upkeep with medicines being properly stored in racks with proper cleanliness and hygiene

This is a step towards storage maintenance and expiry management at the various stores in the state Looking forward to see that the heads of all health facilities take benefit from this module

D ir e c t o r M e d i c a l S e r v i c e s

30

INDEX

Sr No P a r t i c u l a r s P a g e

1 S T O R A G E A N D S T O C K M A N A G E M E N T 4

1 Quarantine and checking of stocks 11 Quarantine area 12 Checks to be carried out on new stocks

2 S t o r a g e 21 Need for proper storage 22 Different patterns of storage 23 Different means of storage 24 Temperatureclimatic conditions 25 Special storage of supplies 26 Storage and stability of medicines

3 Stock Control and Expiry Monitoring 31 Stock control 32 Stock rotation and expi r y m o n i t o r i n g

4 Other aspects of storage 41 Design of a storage area 42 Cleaning and maintenance 43 Product recalls 44 Returned goods

2 A p p e n d i x 1 Templates of letters for use if found not of Standard Quality [Frozen and expired goods ]

Frozen Drugs-ordered to return to the Suppliers-reg(New drug policy 2009)

Frozen Drugs-ordered to return to the Suppliers- for issue of gate pass after verification reg(New drug policy 2009) Stop instruction-reg(New drug policy

2009) Appendix II Material handling in drug stores

31

3 PROCUREMENT ndash Government Order Relating to

the Management of Stores

(Reproduced for reference material on basic

procedure in decentralized system followed by

Health facilities in 1977)

54

F L O W C H A R T S f o r a BI R D S E Y E V I E W o f

P R O C U R E M E N T

5 5

ACQUISITION OF STORES 6 1

PLACING OF ORDERS 6 2

RECEIPT OF STORES 6 2

CUSTODY 6 3

ISSUE OF STORES Maintenance of Stock Books

6 3

PROCEDURE OF INDENTING FOR WARD amp OTHER SECTIONS OF THE INSTITUTION

6 4

HOW OFTEN TO INDENT 6 5

EMERGENT INDENT 6 5

HOW TO INDENT 6 5

KEEPING OF RECORDS IN WARDS A N D S E C T I O N S

6 6

ACCOUNTABILITY OF DRUGS BROUGHT BY THE PATIENT OR RECEIVED IN DON A T I O N BY T H E WARDSECTION _IN - CHARGE

6 7

RESPONSIBILITY OF STORES AT VARIOUS LEVELS

6 7

DISTRIBUTION OF MEDICINES FROM OUTDOOR DEPARTMENT

6 7

LOSS BREAKAGE DAMAGE ETC 6 8

PROCEDURE FOR WRITING OFF STORES 6 9

DISPOSAL OF WRITTEN OFF ARTICLES 7 1

FORMATS TO BE USED 7 3 - 81

32

STORAGE AND STOCK MANAGEMENT The expiry periods of pharmaceutical products have meaning only if the products are stored under proper conditions otherwise products are likely to lose their potency before the actual date of expiry

A pharmacist is a vital link in the distribution chain for pharmaceutical products The medicinal products remain for a long period during the distribution cycle at the wholesaler and at retail pharmacies It is therefore very important to maintain proper storage conditions in these units

Every community pharmacy however large or s mall needs to store and manage its medicine stocks effectively There must be systems to ensure

middot bullbull Secure storage middot bullbull Clean and correct environmental conditions during storage middot bullbull Accurate and effective record keeping middot bullbull Effective stock rotation and expiry monitoring middot bullbull Effective fire and theft prevention middot bullbull Effective rodent pest control

For easier un derstanding this module has been divided into the following sections

1 Quarantine and checking of stocks 11 Quarantine area 12 Checks to be carried out on new stocks

2 S t o r a g e 21 Need for proper storage 22 Different patterns of storage 23 Different means of storage 24 Temperatureclimatic conditions 25 Special storage of supplies 26 Storage and stability of medicines

3 Stock Control and Expiry Monitoring 31 Stock control 3 2 S t o c k r o t a t i o n a n d e x p i r y m o n i t o r i n g

4 Other aspects of s t o r a g e 41 Design of a storage area 42 Cleaning and maintenance 43 Product recalls 44 Returned goods

33

1 QUARANTINE AND CHECKING OF STOCKS

11 Quarantine Area D r u g S t o r e pharmacies receive stoc k s f r o m su pplie r s a c c or d ing to pur c h a se o r d e r s T he stock that is received must be visually checked for quality and quantity The stocks must be kept in a separate area until the checking is done to avoid intermixing with existing stock This necessitates the presence of a separate area within the pharmacy w h e r e i n t h e storage and other checking of stocks can be performed This area is called the QUARANTINE AREA This area should be marked and identified adequately to distinguish it from other areas

The area may be marked using different means 1 ) A s m a l l board saying Quarantine on a separate table used exclusively if it is in the middle 2) A board on the wall if the table on which the quarantine stock is placed is against the wall

middot Stock received from wholesalers should be immediately transferred t o t h e Quarantine Area

middot In the Quarantine area the stock may be stored on racks shelves or in cupboards to prevent ingress of moisture dirt and other contaminants

middot Regular stocks from the pharmacy should not be left kept in the quarantine area Special care has to be taken in case of refrigerated medicines supplied by the suppliers so tha t the y do not remain in the quarantine area for long periods of time They should be immediately checked on receipt and transferred to areas for refrigerated storage s o a s to maintain the cold chain bull

Advantages of having a separate Quarantine Area middot Avoids cross mixing of newly arrived stock from existing stock till it is checked middot Lays stress on checking the quality of the stock received middot S to ck checking ensures t hat defective andor expired goods do not enter the storage areas

34

bullbull

bullbull

12 Checks to be carried out on new stock

Unpacking and checking stock

Supplies received should be unpacked and checked in the quarantine area Staff doing the checks should be adequatel y trained in what they have to check when stock arrives

Checking should be seen not simply as counting the units received but as a part of the quality assurance system bullThis should include middot Visually inspecting the packaging middot Checking the integrity of containers middot V erifying the completeness and leg ibility of la b e ls ( a ppr o ve d dr u g name strength any special storage instructions and expiry date)

bull

The expiry dat e should be checked to ensure that there is adequate shelf life remaining

Supplies should be individually checked using a checklist 35

Checklists

36

The wholesaler supplying the product should be notified immediately in case of any discrepancies ( and the details should be recorded in a register) and sent in a written format to the supplier It should include middot Missing boxes or cartons middot O p en tampered boxes or cartons middot Missing supplies middot Differences in the actual quantity and the quantity shown on the packing middot Additional medicines that had not been ordered but have been supplied middot D a m a g e d b r o k e n o r p oor quality medicines middot Any other discrepancies

The purchase invoices are an important aspect to be considered The invoiced documents should be signed and filed for reference as per the Drugs and Cosmetics Act and retained for at least 3years

If the wholesaler supplies medicines as an emergency without a bill or against a delivery challan

middot The supplies should be checked for integrity and inspected for damage middot The details of supplies received should be recorded middot The supplier should be asked t o send the bill as early as possible middot When the bill is received it should be checked against the details recorded and anomalies if any should be reported to the supplier

To keep a track of the received stock maintaining a S t o c k R e c o r d C a r d c a n b e very useful The entries in the stock record card can be made while checking the stock received STOCK BIN in the stores should have Stock record card

Maintaining a stock card for every product may not be very practical for a retail pharmacy however it could be maintained for costly medicines Nowadays it is much more practical and easier to maintain records using computers

The pharmacist should ensure that medicines manufacturedmarketed by a company are received only through an authorized distribution network of that company This is important to prevent spurious and counterfeit drugs from entering the pharmacy

37

2 STORAGE 21 The need for proper storage The storage of medicines and other products is an important requirement of Good Pharmacy Pr actice Appropriate storage of medicines is essential -

middot bullTo ensure that the potency is maintained middot bullTo prevent deteriorationspoilagedegradation middot bullTo ensuremaintain physical integrity

To ascertain that the quality and safety is maintained throughout their shelf life Storage requirements need to be considered on 2 aspects

a) Integrity of medicines Medicines should be stored in such a way so as to maintain their integrity and potency middot Maintain the right temperature required middot Protect from excessive humidity middot Keep medicines away from direct sunlight middot Protect from pests and rodents

b) Physical location middot Should be easy to locate middot Accessible middot Orderlysystematically placed

2 2 D i f f e r e n t p a t t e r n s o f s t o r a g e The pharmacist could follow any of the different patterns of storage The pattern of stora ge should be selected in such a way that it facilitates speedy and efficient dispensing of medicines

The pattern of storage could vary with each pharmacy experience usual practiceroutine of staff and the person-in charge and also depending on space av ailable turnover etc (i) The medicines could be stored c o m p a n y w i s e ie the medicines manufactured by one company should be grouped together and kept in one place Within each company shelfshelves the medicines may be placed in alphabetical order for easy and quick placement and removal Also bottles tubes boxes etc may be segregated within that shelf

38

(ii) The medicines may also be stored in a lphabe t ic al o r de r ie they are placed in order from left to right based on their name The first letter of the name is used to g r o u p t h e m e d i c i n e s t o g e t h e r a n d k e e p t h e m i n o n e l o c a t i o n I n s o m e p h a r m a c i e s a l l t h e strip packing are placed in drawers or boxes in alphabetical order each box or drawer containing strips of one particular alphabet This system ensures that the strips always remain e n c l o s e d i n t h e b o x e s d r a w e r s a n d a r e n o t e x p o s e d t o d u s t T h e d i s a d v a n t a g e i s that it might lead to mix -u p o f strips in the same drawer and it may cause a problem incase of similar looking strips in which case a wrong medicine may be dispensed Secondly cut strips lying around in the drawer may lose their identity if the batch n u m b e r andor expiry date is not seen on the cut portion of the strip

39

(iii) The medicines may be stored according to their therapeutic class ( e g a n t i b i o t i c s anti asthmatics or anti hypertensives) ie the medicines are kept together based on their pharmacological or therapeutic action

(iv) The medicines may be stockedsegregated according to dosage forms eg l i q u i d s (bottles) solid oral dosage forms eye drops rotacaps ointments etc all stored on separate shelves

Always Remember I Storage of prescription medicines should preferably be separate from OTC medicines OTC medicines especially those that a r e a d v e r t i s e d m a y b e d i s p l a y e d f o r c l i e n t s t o select or to ask questions about [OTC-O v e r t h e c o u n t e r ] II Storage according to temperatures is a must no matter which pattern of storage is followed Also within a particular storage area segregated storage may be maintained In a refrigerator for example medicines may be stored in trays racks and the freezer according to the temperature required

40

Whatever pattern of storage is selected all the personnel should ensure that middot The stocks are stored in an orderly manner middot The medicines are kept back in the same place from where they were removed middot All medicines are arranged neatly once in a while

middot The personnel should be careful while storing the medicines middot They should not throw the medicines haphazardly 23 Different means of storage

middot Within each temperature and security zone medicines must be stored so that they are easily accessible and protected against damage

middot Basic means of storage include shelves racks and drawers middot To prevent dust from entering the shelvesracks it is ideal to have glass

shutterssliding glass doors This can however be disadvantageous because accessibilityspeed is hampered in removing a product from the shelf because the glassshuttersliding glass has to be

41

opened m o v e d e v e r y t i m e a p r o d u c t h a s t o b e p i c k e d u p U s e o f a i r c o n d i t i o n e r s f o r t h e p h arm acy with a closed door at the e n t r a n c e o r a n a i r c u r t a i n c a n r e d u c e t h e d u s t problem In such cases the shelvesracks may be left o p e n

bull

middot Direct storage of cartons on the floor should be avoided because besides being an unhealthy practice the contents may also be damaged by moisture bull

middot Store medicines preferably in shelves with glass shutters for visibility middot Closed shelves further prevent dust from going in especially in India where most

pharmacies are located along busy roads middot Some medicines have to be refrigerated or stored in a cool or cold place Having a

refrigerator or two (as per the need of the pharmacy) is essential to store suc h medicines at temperatures mentioned on the label bull

42

Refrigeration middot All cold chain equipment should meet required standards middot Improvement in refrigeration technology has provided frost -free refrigerators

Pharmacists should opt for frost-free refrigerators as they are easy to maintain and protect printed packaging materials Conventional refrigerators may cause water falling from trays below the freezer on medicines stored in the refrigerator thus causing soggy labels

middot bull Frost-free refrigerators also provide separate and large compartments for the freezer portion (required for storing medicines needing sub-z e r o t e m p e r a t u r e ) and the main storage area with separate doors so that opening one door does not disturb the storage temperature in the other compartment

Care should be taken to keep the refrigerator on 24 hours a day It should not be switched off after working hours It is advisable to have an inverter connected to the refrigerator so that the refrigerator re mains working even when there is a power outage

middot The refrigerator door should be closed tightly middot The refrigerator door should not be left open for too long middot Space should be left between medicines stored in a refrigerator to allow air to

circulate middot The ref rigerator should be placed about an arms length away from the wall

This will increase air circulation thus not affecting the cooling within the refrigerator

middot Vaccines should not be stored on refrigerator door shelves as they are exposed to warmer temperatures each time the door is opened Vaccines should always be stored on the middle shelves of the refrigerator

middot Refrigerated medicines should not be left out of the refrigerator for more than a few minutes

43

middot Consumable products like juices energy drinks e t c s h o u l d n o t b e s t o r e d a l o n g with medicines in refrigerators If required they may be kept in a separate refrigerator

middot An adequate number of refrigerators should be planned to store the entire stocks requiring refrigerated storage

middot Adequate procedures should be followed for defrosting cleaning and maintenance of refrigerators

middot Icefreeze packs should be kept in the freezer compartment so that they can be used for transporting cold temperature medicines The packs can be given to clients along with the medicines requiring cold temperature storage so that the temperature is maintained till the client reaches home and can then put the medicines in a refrigerator) Freezer packs can also be used to keep medicines temporarily in case there is a power outage or refrigerator breakdown

Activity

Prepare a SOP (Standard operating procedure chart) for cleaning a refrigerator Discuss it with your staff finalize its maintenance once a month through AMC -A n n u a l Maintenance contract CMC - Comprehensive maintenance contract and put it up on the pharmacy refrigerator Put the Purchase Order details name of manufacturer Phone of Service Engineer and a register to login the Machine service and down timeService reports may be maintained properly

Refrigerator monitoring and maintenance

middot bullIt is important to carry out routine monitoring and maintenance of the refrigerators and to organize an effective repair system

middot bullThe temperature in the refrigerator must be monitored and recorded routinely at least once a day

middot Any breakdown must be reco rded including the period during which the medicines were exposed to uncontrolled temperatures Medicines may then be kept or discarded depending on the problem guidelines or the manufacturers advice

middot Cold chain monitor cards and devices in or on packages that change color or otherwise alert staff to potential damage assist in monitoring (These are likely to be introduced in India soon)

middot It is essential to have a contingency plan in place before a refrigerator breaks down An arrangement can be made to move the contents to a private refrigerator elsewhere in the community or to obtain a regular supply of ice packs until the defect is rectified

Put filled water bottles in the bottom half of the refrigerator door in order to provide cooling in the refri g e r a t o r w h e n t h e r e i s a p o w e r o u t a g e T h i s m i g h t t a k e c a r e o f t h e temperature when there is no current for a couple of hours If the power outage is expected to last for several hours special arrangements such as an inverter UPS have to be made to keep the refrigerator constantly running in the absence of electricity middot Defrost the refrigerator in case of excessive ice formation and preferably at regular

intervals Keep a record of the same

44

2 4 T e m p e r a t u r e c l i m a t i c c o n d i t i o n s

i) Temperature control middot The medicines in a pharmacy need to be stored at appropriate temperatures to

maintain their stability middot An air-conditioned environment where temperature can be controlled is

recommended for pharmacies Air conditioning offers the option of setting the t e m p e rature as per requirements

middot bullIt is ideal to have an air conditioner to maintain the temperature below 25 C as most medicines require storage below this temperature Secondly this temperature is pleasing to both the staff and the visiting customers too

middot In the absence of an air conditioner circulating fans may be used middot This need is felt even more in certain parts of India where temperatures soar above 45

C and some areas where it falls to sub zero temperatures In such cases temperature maintenance is essential to prevent deterioration of medicines due to unnecessary exposure to drastic temperature fluctuations

middot This need is felt even more in certain parts of India where temperatures soar above 45 C and some areas where it falls to sub zero temperat u r e s I n s u c h c a s e s temperature maintenance is essential to prevent deterioration of medicines due to unnecessary exposure to drastic temperature fluctuations

i i ) Humidity or moisture control Moisture or humidity can adversely affect the stability of me dicines such as tablets capsules powders

45

Gelatin capsules become soft and swell on absorption of moisture The drug content of tablets may undergo surface hydrolysis The presence of moisture may encourage the growth of microbes It is therefore essential to control humidity

To reduce the effect of humidity the following suggestions may be followed -middot Open the windows to allow air circulation Use a fan to circulate fresh (outside) air middot In humid climate a dehumidifier is useful for preventing mo i s t u r e d a m a g e ( i n t h e absence of an air conditioner) middot For bulk containers of tabletscapsules do not keep the container open for a long time and replace the lid or closure immediately after taking out the required number of medicines for dispensing middot Do not allow the medicines to touch the floor or the walls The walls may be damp and may cause moisture absorption damaging the product

middot Calibrated thermometers and manometers can be used to detect temperature and humidity in the pharmacy

middot Periodici t y of checking the temperature should be fixed middot The climatic conditions should be recorded and documented middot Temperature charts should be available for ready reference

Documentation is one of the core activities for achieving and maintaining quality It is one of the most essential components of validation Temperatures in various areas

46

including refrigerators should be recorded at a predetermined periodicity usually daily at the hottest time of the day and such documents should be preserved i i i ) Storage conditions A number of storage conditions are mentioned on the labels of medicinal products These conditions have to be properly interpreted and appropriately complied with

According to the Drugs and Cosmetics Rules 1945

1 The term cool place means a place having a temperature between 10 C and 25 C

2 The term cold place means a place having a temperature not exceeding 8 C In case of storage conditions for specific products please refer to Schedule P The Drugs and Cosmetic Rules 1 9 4 5

The Indian Pharmacopoeia specifies the following storage conditions -

Wherever the condition for storage is not specified medicines may be stored under normal temperature In a country like India however where normal temperatures soar to h i gh temperatures it is recommended that medicines be stored in a cool place

Activity Prepare a list of the storage requirements mentioned on the label of about 20 products in your pharmacy and check if the temperature is maintained

47

25 Special Storage o f s u p p l i e s If the product has no special instructions normal storage conditions apply This means storage in dry clean w e l l -ventilated premises at temperatures of +15 C to +25 C or depending on the climate up to +30 C (WHO1990) Storage instructions are product specific Different brands of the same generic drug may have different storage requirements as they may have different packaging or formulations It is essential to follow the product manufacturers storage instructions to the maximum extent possible Less stable medicines must be stored in specific conditions to maintain their quality or potency

The following products require special storage facilities

middot Products that must be kept frozen (usually vaccines and sera) middot Products sensitive to h eat an d r e q uir in g r e f r ig e r a tio n ( +2 C to +8 C) middot Products that have reduced shelf life at uncontrolled room temperature and need

mechanical ventilation or air conditioning middot Flammable products that require separate fireproof premises middot Products prone to theft o r m i s u s e

Products needing storage in a controlled environment -

The usable shelf life of the following products may be reduced if stored at uncontrolled humidity or at room temperature in hot climates -

middot Some injectables (eg adrenaline) Most injectable preparations are less stable than solid oral forms (tablets and capsules) Injectable preparations in solution are particularly unstable Many injections must be protected from light as well as heat

middot Intravenous fluids (particularly if packed in p lastic containers) middot Some suppositories pessaries creams and ointments These products may melt at

temperatures greater than 30 C Once this happens it is not advisable to use them because the active ingredient in the formula may get unevenly distributed

middot Products containing rubber latex cellulose or some plastics Condoms most sterile disposable medical devices and surgical products such as syringes needles and catheters require protection from excessive humidity and strong light and heat Any o f these conditions may make products brittle stained amp unusable Sterility cannot be assumed if packaging is damaged

In hot climates these products should be stored in the coolest place possible preferably with air conditioning or air circulation fans

48

Products needing freezing or refrigeration-middot Vaccines blood products and many other medicines lose potency if kept even for a

brief period at temperatures outside the recommended range For these products the cold chain must be maintained at every stage of the distribution system

middot Freezing is as damaging as high temperatures for some products including injectable contraceptives ergometrine insulin adrenaline and the DPT DT TT and Hepatitis B vaccines Such products therefore sho uld not be allowed to freeze (not be kept in the freezer compartment)

middot Short periods at room temperature (during transportation or local distribution for instance) may be acceptable for many products (such as ergometrine a n d i n s u l i n ) e v e n t h o u g h s u c h e x posure can to some extent reduce shelf life Other items such as vaccines should always be transported in cold boxes

Storage of insulin injections-

middot Insulin should always be stored in a refrigerator at the recommended temperature of 2 -8 C

middot Insulin should not be kept in the freezer compartment of the refrigerator middot Insulin should ideally be stored horizontally middot It should not be exposed to sunlight or excessive heat middot Insulin suspensions should not be used if the suspension cannot be properly

resuspended due to cake or clump formationbull

Controlled drugs -Narcotics (for example Pethidine injection morphine preparations) and other specified drugs that may be abused are governed by special legislation and regulations The following security measures are suggested in the pharmacy -middot A safe or reinforced double locked cabinet fitted with a light (preferably with a red

bulb) that comes on when the door is opened

49

middot A special register recording details of each receipt or issue with 2 signatures physi cal counting of medicines after each entry and signatures at handover takeover

middot Independent audit (by supervisors and drug inspectors)

Products prone to theft abuse or misuse -

Some medicinesproducts are particularly prone to theft abuse or misuse These include expensive medicines (eg insulin) certain antibiotics and products prone to abuse or misuse like psychotropics etc

Such medicinesproducts should be stored adequately They require stricter record keeping and more frequent stock taki ng than others Periodic audits should be carried out to check for consumption against actual recorded use (registers prescription records stock records etc) to expose any theft or misuse bull26 Storage and stability of medicines Medicines are not stab le indefinitely They are stable for a specific period of time sometimes for a brief period Poor storage conditions accelerate the drug degradation (decomposition) Temperature light and moisture are the most important contributing factors for drug instability It is important to identify and be aware of the potential for instability There is a need to comply with storage requirements to ensure quality medicines for patients It is also important to offer advice to patients too about appropriate storage o f medicines at home The dispensing label should state the storage condition required and be backed up by a verbal reminder especially where special storage is required bull

50

In case stability and storage problems are seen with formulations they should be reported immediately to the representative of the manufacturer and taken out of circulation till the stability problems have been resolved

The pharmacist can easily detect stability problems when products show change in appearance color odor settling of the product contents breaking of emulsions melting of creams oozing of contents from the containers and any such physical changes

3 STOCK CONTROL AND EXPIRY MONITORING 3 1 S t o c k C o n t r o l For economic reasons pharmacists do not like to have stock on their shelves for long periods of time The aim should always be to keep stock at a level that will just meet demand Normally most manufactured medicines have a long shelf life Even then it is essential that there is efficient stock rot ation so that the older stock is used first It is also a good practice to check the expiry date as an integral part of the dispensing process When short shelf life products are involved stock levels may have to be modified to prevent medicines regularl y expiring on the shelves

32 Stock rotation and expiry monitoring In order to avoid accumulation of expired and obsolete stock medicines should be stored and issued according to the following guidelines -middot The stock control system must record the ex p i r y d a t e a n d t h e d a t e o f r e c e i p t middot Stock must be stored so that earliest expiring batches are picked and issued first middot The First In First Out (FIFO) system - In this system the stock which is received

first is sold first This system however may not be useful for pharmacies because most of the stocks carry an expiry date For pharmacies the FEFO system is more practical

51

middot The First Expiry First Out (FEFO) system - In this system the stock having an earlier expiry is sold first The stock with longer shelf life should be placed farthest to the back (or at the bottom in case o f sta c k e d b oxe s) T h is is pa r tic u la r ly impor ta n t with products that have short shelf lives such as vaccines some vitamins antibiotics etc and reduces losses due to expiry

middot E x p i r y dates should be noted on the stock record upon receipt Stock nearing expiry should not be accepted unless it can be used before expiry

Computerization and expiry monitoring In the pharmacy computerization facilitates both checking stocks and expiry mo nitoring and helps-bullbullKeeping a check on products nearing expiry bullbullKeeping a check on non- moving and slow moving products bullbullTo facilitate the removal of medicines nearing expiry from shelves in time to send them back to the wholesaler or supplier

Periodic checking for expiry The expiry date for medicinal products is a critical aspect in pharmaceutical dispensing and due importance should be given to it Periodic checking for expiry of medicines will ensure that the patient will never receive products that have crossed their expiry date During periodical checking of expiry the personnel involved should remove medicines that are nearing expiry bullbullIn -house threshold periods should be set and followed for retrieval of such medicines from the shelves bullbullSuch medicines should be stored separately These should either be dispensed immediately (thus ensuring that they are used before the expiry date) o r t h e y s h o u l d b e returned to the suppliers bullbullA separate area should be designated (cupboard or shelf)marked[FROZEN ZONE] which is adequately marked EXPIRED GOODS- NOT FOR SALE to store all expired stocks FROZEN ZONE

52

Remember Expired medicines are a NATIONAL WASTE So stock only what you can sell Avoid expiries save precious medicines for the nation

Treatment and disposing of expired medicines bullbullProcedures need to be in place for the treatment of expired medicines bullbullThe expired medicines need to be collected and be sent back to the supplier or company for appropriate disposal bullbullRecords must be maintained for expired medicines and how they are disposed off bullbullIn case of medicines that are not returnable to suppliers procedures for disposal need to be followed by the pharmacy in conjunction with the FDA The following procedure can be followed if medicines cannot be returned to suppliers ( T h e b a s i c p h i l o s o p h y of appropriate disposal is to prevent their re- circulation and use) bullbullC u t t h e c o n t ainer in such a manner that the label is also cut In case of tablets and c a p s u l e s d e s t r o y them by disposing them in a bucket of water bullbullUse landfill procedures (deep burial into the ground as per stipulations of Medical Waste Disposal Act prevalent in the respective state) bullbullPour the liquids into the sink and wash away with sufficient quantity of water bullbullKeep a record of such disposal with full details of medicines destroyed Although these measures are usually adopted care has to be taken with such tr e a t m e n t a s studies have shown that flushing of medicines has resulted in tracessmall quantities of medicines being found in waterways and groundwater having potential health and environmental effects

4 O T H E R A S P E C T S 41 Design of storage areas The following important factors need to be considered in design of storage areas -middot The retail outlets in hot areas in summers should be air-conditioned Similarly in

a r e a s o f e x t r e m e c o l d t h e p r e m i s e s w o u l d r e q u i r e w a r m i n g e s p e c i a l l y i n w i n t e r s t o maintain cool temperatures The placement of air -conditioners and heating devices should be such that medicines are not directly exposed to the cold or heat

middot Due consideration should be given to storage requirements of formulations while designing shelves and cupboards in retail outlets Sufficient shelf height should be provided so that all liquid products can be stored vertically As far as possible the shelves should be covered with glass panels to protect medicines from dust and p r e v e n t r a p i d f l u c t u a t i o n s i n temperature

middot Medicines should be stored according to the storage instructions on the labels bullIt is ideal to have a door at the pharmacy entrance to prevent dust from coming in as well as reduceprevent cooled air from going out This may not however be considered feasiblepracticable by many pharmacy owners for fear that clients may not enter the pharmacy because the door may act as a barrier An air curtain is a good alternative to a door

middot There should be minimal direct sunlight falling on the products Particular consideration should be given to premises directly facing the sun

middot bullThe arrangement of lighting in the interior of the premises should also be in a manner that the lights are not focused on the products It has been shown that light causes not only chemical damage but also can catalyze physical changes like moisture uptak e by the products Care should be taken to ensure that only diffused light falls on them

53

middot As far as possible provision should be made for a temperature and humidity indicator device in a pharmacy These devices are now easily available

middot Stability studies o f m e d i c i n e s p a c k e d i n b l i s t e r s h a v e r e v e a l e d t h a t i f t h e s e a r e exposed to light they tend to absorb moisture It is therefore necessary to store them in suitable cartons so that the blisters are not exposed to light Pharmacists should do this even if the manufacturer has not provided cartons

middot Light and temperature sensitive products should not be stored on counters where the light is intense or direct and there is no protection from temperature and humidity

42 Cleaning and maintenance i) Cleaning of storage areas

The storage areas of the pharmacy should be cleaned periodically and cleanliness should be maintained at all times The Standard Operating Procedure for cleaning should be designed and followed accordingly Schedules for cleanups should be laid down and adequate cleaning equipment should be made available

Tips for maintaining cleanliness middot Provide clean pieces of cloth for wiping at various locations in the pharmacy

Replace with clean cloth at regular intervals middot Keep separate pieces of cloth for floors shelves and medicines middot Use a disinfectant andor soap solution to clean floors middot Ensure removal of dust and prevent accumulation of dirt middot Ensure removal of cobwebs middot Use a vacuum cleaner for cleaning areas not easily reachable middot T a k e c a r e t h at breakages are handled and cleared effectively middot Observe the factors leading to waste generation in the pharmacy and take appropriate

measures to tackle the problem middot Record all cleaning procedures performed and maintain all the documents required

For ex a m p l e -bullbullThe floor of the pharmacy may be swept with a broom and swabbed with soap water every morning bullbullThe floor may be swabbed with a disinfectant every week bullbullThe entire premises including shelves and cupboards may be cleaned with a cloth (to remove dust and to check for medicines approaching expiry date or expired medicines) every three months bullbullAll the steps followed should be r e c o r d e d

The floor shelves drawers have to be cleaned and a check should be kept on dust cobwebs spillages due to breakage etc It is therefore essential to have SOPs for cleaning laying down cleaning frequencies allotting responsibilities and maintaining a daily record in the logbook to document all these activities

54

While cleaning dust settled on dosage forms like bottles tubes etc should be removed Before dispensing the products should also be wiped to remove any dust settled during storage

For refrigerators bullbullDefrosting and cleaning should be done at regular intervals bullbullSwitch off the refrigerator while cleaning bullbullCleaning should be done quickly and stocks put back immediately

i i ) Pest control Pests are a serious problem in India where insects reptiles and rodents (eg cockroaches l i z a r d s r a t s s i l v e r f i s h (Deemak - in Hindi ) etc) may find access to the pharmacy storage areas Insects like ants and borer ants may often attack wood in the pharmacy causing d am ag e to shelves cupboardsPest c ontr o l in a p h a r m a c y c a n b e a d i f f i c u l t t a s k b u t t o avoid possible contamination and physical damage to stock it is necessary to keep pests out of the pharmacy premisesPest control measures should be implemented with proper p r e c a u t i o n s t a k i n g u t m o s t c a r e t o a v o i d contamination of medicines

55

Th e following pest control measures c a n be ta ke n f r om tim e to tim e -bullbullRat bait and traps can be placed at various locations bullbullInsecticutors can be used on a permanent basis bullbullInsecticidal sprays and repellants can be used from time to time

i i i ) Fire precautions

Combustible trash such as cartons boxes and other packing waste must not be allowed to accumulate in the store Waste should be deposited in appropriate waste bins and be d i s p o s e d o f f o n a d a i l y b a s i s

F i re detection and fire fighting equipment must be maintained and regularly inspected The pharmacy personnel should receive adequate training in fire fighting techniques and emergency actionFire prevention measures should include a prominently displayed ldquoNoSmokingrdquo sign careful handling and disposal of combustible waste materials and checking of electrical connections at regular intervals

iv) Security middot Doors shutters of the pharmacy should be strong and be fitted with secure locks middot Counters should be designed so that unauthorized personnelclients do not have

access to areas where prescription medicines are stored Access to such areas should be restricted to the pharmacy staff

middot All the pharmacy staff handling supplies should be accountable for their ac t i o n s

56

middot bullSpecial care must be taken in case of Schedule X and manufactured drugs (under NDPS Act) Such medicines should be kept under lock and key and the key should be kept with the Chief Pharmacist or i n h i s a b s e n c e t h e s e n i o r p h a r m a c i s t

v) Breakagespillage and damaged product Products that have been damagedspoiled during storage and handling spillages and broken glassware should be disposed off according to procedures laid down by the pharmacy Broken and damaged products s h o u l d b e p l a c e d i n a segregated area to be returned to the supplier

vi) Inspection Senior staff should inspect all pharmacy areas regularly The shelves and drawers should b e c h e c k e d d a i l y f o r signs of pests and dust Ceiling and walls should be checked for dirt and cobwebs Stock should be checked on a regular basis for deterioration due to climatic conditions

43 Product recalls Products found to be defective should be quickly recalled (withdrawn from the market) The instructions are generally issued either by the manufacturer or the regulatory agency The level of recall is determined by both the degree of risk and the extent of distribution of the product and in India is mainly directed at the distribution chain

On receiving the details of the defective substandard spurious batchbatches of a medicine to be recalled from the manufacturer or the stockist or the FDA the pharmacy should immediately check if the particular b a t c h i s i n s t o c k a n d i f s o s u s p e n d i t s s a l e immediately

Similarly if the regulatory authority in the country bans a particular medicine or FDC the pharmacy should immediately check and remove all the different brands of that particular medicine under consideration

The details of medicines and their batches to be recalled should be available in the q u a r a n t i n e a r e a w h e r e stocks are received and checked This is to ensure that such medicines do not come into the pharmacy

middot The pharmacy should develop SOPs for recall of medicines middot The pharmacy staff should be immediately informed about such medicines and

the details should be displayed in writing in a prominent place in the pharmacy middot Rapid action helps avoid unnecessary exposure to such medicines once the

problem has been d e t e c t e d middot The progress of the recall procedure in the pharmacy should be monitored every

few days to ensure complete compliance middot All stocks of the recalled products should be stored separately from the saleable

stock These can be stored in the expiry cupboard segregated from the expired goods and be appropriately labeled ldquoRecal l e d G o o d s - Not for Salerdquo

The supplier should be notified and asked to replace defective products middot All the details of the procedures followed should be duly recorded in a Recall

Register maintained specially for the purpose The register should include d etails such as -middot Date of the recall middot Nam e of the product

57

bullbull

middot Details of the product (name of manufacturer batch number expiry date) middot Nu m b er of units purchased sold a n d sto c k in ha nd middot Reason for recall middot Nam e of the supplier to whom produc ts w e r e returned along with the date and quantity middot Name and signature of the designated personnel carrying out the recall procedure and recording details middot Name and signature of the chief pharmacist verifying the recall procedures and recording details 4 4 Returned medicines

Medicines may be returned to the pharmacy by clients due to the following reasons -bull

bullbull Unused medicines bullbull Course not completed bullbull Therapy changed by doctor bullbull Side effects experienced by patient bull

bullbull DamagedDefective medicines bullbull Missing or defaced label bullbull Missing tablets in a stripblister bullbull Leakage in bottles bullbull Leakage in strips bull

bullbull Expired medicines

Appropriate SOPs should be framed and followed for their acceptancerefusal and disposal middot bull For unused medicines returned by clients the p harmacy personnel should verify

that these were purchased from their pharmacy They should then be checked for integrity of the packing the dosage form and the expiry date and verified with the client whether they were stored in appropriate conditions This again is at the discretion of each pharmacy

middot The damageddefective medicines returned to the pharmacy should be taken back and stored separately Existing stock of the same product should be checked for similar defects

middot Expired medicines should be accepted from clients at the discretion of the pharmacist and be immediately shifted to the expired goods cupboard These can be stored segregated from the pharmacys own expired goods and be appropriately labelled ldquoExpired Goods returned by clients- Not For Salerdquo

It is advisable not to accept returned medicines requiring cold chain storage (refrigeration) because it cannot be ensured that the cold chain was maintained when the medicines were in the hands of the patientclient middot Appropriate adjustments in t he stocks should be made for medicines

returnedexchanged to update the inventory middot The medicines should then be returned to the respective shelves middot A lsquoReturned Goodsrsquo register needs to be maintained to record all details of returned

medicines

R egister should include such details as-

58

middot N a m e o f t h e p a t i e n t middot Nam e of the product and quantity r e tu r n e d middot Product details such as the batch number and expiry date middot Condition in which received middot Reason for returning products middot Compensatory measures taken wi t h r e s p e c t t o c l i e n t middot Action taken with respect to product middot Name and signature of the personnel accepting the returned medicines and recording details middot Name and signature of the chief pharmacist verifying the recorded details

What the pharmacist would have learnt from this module The storage of medicines is a critical factor in the distribution cycle bullbull Stocks received by the pharmacy should be quarantined in a separate area and necessary checks s h o u ld be performed to ascertain the qua lity a nd quantity of stocks received bullbull Whatever pattern and means of storage used the products should be stored so as to maintain their potency and integrity bullbull Storage conditions should be monitored and maintained on a regular basis bullbull Optimum stock levels should be maintained and regularly monitored for expiry bullbull The design of storage areas should facilitate appropriate storage of medicines bullbull Cleanliness should be maintained in the pharmacy bullbull Adequate measures should be taken in case of returned medicines and recalled products

Optimum storage of medicines is mandatory whether at the distribution stage at the pharmacy or ultimately within the homes of patients The pharmacist has an important r o l e t o p l a y i n t h e s t o r a g e o f m e d i c i n e s i n m a i n t a i n i n g d r u g p o t ency and efficacy and thus facilitating optimum therapeutic benefits Good Pharmacy Practice - IPA -CDSCO - WHO Appendix I Quality Assurance Templates of letters for use if found not of Standard Quality [Frozen and expired goods ]

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated To Name of the Supplier with address

Sub Not of Standard Quality GoMP-Supply of Drugs and medicines-(Codename) Return of Stocks to the Suppliers-reg(New drug policy 2009) Previous letterinvoice ref Sl No Drug Code Drug name

Manufacturing date Expiry date

Supplier address

B a t c h n o

The above items of PO nodated was drawn by the Drug Inspector (Place) on (______________date) as a statutory sampling and declared ldquoNot of Standard

59

Qualityrdquo on -(______________date) by the Government Analyst for the following reasons

- ldquoThe product sample do not confirm to IP specification for (Drug codename with respect to the content of drugrdquo

- ldquoThe product has already been blacklisted by TNMSC on -(______________date) for the failure of (quantity) of batches of drug codenamerdquo

As per the clause of the te nde r d oc um e nt ldquo I f the sa mple s d o not c onf o r m to statutory standardsthe tenderer will be liable for relevant action under the existing laws and the entire stock in such batch should be taken back by the tenderer within a period of 30 days o f t h e r e c e i p t o f t h e l e t t e r f r o m t h e v e n u e

The stock shall be taken back at the expenses of the tendererthe Procurement Authority have the right to destroy such Not of Standard Quality if the tenderer does not take back the goods within the stipulated time

The Procuring Authority will arrange to destroy the Not of Standard Quality drugs within 90 days after the expiry of 30 days mentioned above without further notice and shall also collect demurrage charges calculated at the rate of 2 per week on the value of the drugs rejected till such destructionrdquo

Hence we regret to inform you that you will have to take back the stocks available of the abovesaid batch at your own cost from the drug stores where you have supplied the above batch

Kindly acknowledge the receipt of this reference at once

P r o c u r e m e n t A u t h o r i t y Seal and Stamp

Copy to Ref No dated

1 ) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated13082010

To

Sub Frozen Drugs-ordered to return to the Suppliers-reg(New drug policy 2009) Previous letterinvoice ref

The following products which were earlier frozen have now been ordered to return to suppliers directly with permission from the State drug Authority In this regard the suppliers have been instructed to take back their failed batch from the drug store of the stores Hence you are now instructed to return the following failed batches to the suppliers by obtaining proper authorization letter and acknowledgements from them

60

Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

Kindly acknowledge the receipt of this reference at once

Procurement Authority Seal and Stamp

Copy to

Ref No dated 2) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated14092010

To

Sub Frozen Drugs-ordered to return to the Suppliers- for issue of gate pass after verification reg(New drug policy 2009) Previous letterinvoice ref

The following products which were earlier frozen have now been released Hence they may be issued Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

Kindly acknowledge the receipt of this reference at once

Procurement Authority Seal and Stamp

Copy to

61

Ref No dated 3) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated

To

Sub Stop instruction-reg(New drug policy 2009) Previous letterinvoice ref

Until further instructions stop issue all the batches of the following item Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

You must intimate the available stock in the stores of the said batch Number to the Procurement Authority immediately Also retrieve quantity if already issued

Procurement Authority Seal and Stamp

Copy to

Ref No dated 4) HOD Procurement Office of

62

Appendix II Material handling in drug stores

Rack approx rates and dimensions

S No

Item Description UOM Approx Rate

1 MEDIUM DUTY RACK SIZE 2900 H X 3090 W X 800 D IN MM (AS PER SPECIFICATION)

Each 2499800

2 MEDIUM DUTY RACK ADD ON UNIT FOR SIZE OF SR NO2

Each 2243100

To locate a Box no 3 Rack no 14 in row3

SAMPLE OF RACK no Bin numbering -------------- S a y R K 1 4 R o w 3 B o x 1 6

SAMPLE LAYOUT of RACKS in a Drug Stores

63

Sample of another warehouse of distribution warehouse system

64

65

Slotted Angle racks with bin cards

66

Plastic Pallets

Plastic pallets ar e l i g h t w e i g h t l o w- c ost and exceed industry standards for strength and durability

NOTE A pallet has bottom deckboards (see sketch) A skid does not have bottom

67

deckboards

Battery Operated Stacker

Electric Stacker Ehh (Manual Push Type) - Manual drive - Lifting electrically with Battery 12 V 88 Ah - For loading and un-loading of trucks - Battery and loading device built - in - Battery charge gauge and charging current gauge Simple and Easy Operation - Lifting and Lowering electrically direct on steering arm - Pulling and pushing through steering arm - Electrically operated relief valve on hydraulic aggregate Safe Operation - Emergency Off Switch - Constant lowering speed - Protection through lowering brake valve - Overload protection through overload brake valve - Load chains covered preventing pinching threat - Electrically interlocking during loading process - Secured battery compartment opens upwardly - Stable buffering of the steering arm in upright position - In accordance with EWG Guidelines 89 240 - In accordance with VBG 12b Prevention of Accidents

Pallet Truck [ Top ]

68

----------------------------------------------------------------------------------------------------------------------------

For Transport Of All Goods On Pallets Safe and Easy Operation - through single hand operation Lifting moving

lowering with steering handle - neutral position of the hydraulic possible - overload pressure relief valve Long Service Life - robust co n s t r u c t i o n

- special hardened axles - hardened chromium plated ram - maintenance free Easy Maneuverability - through rubber steering rollers - nylon fork rollers

A h a n d t r o l l e y

69

Trolley with plastic bins for several items del ivery

70

Digital Weighing balances

Balances amp Scales EF Seriers Precision Electronic Balance

71

1

Ice lined Refrigerators

600 litres refrigrator

72

Walk in cooler

vacuum cleaner

73

bull S y s t e m

7

bull System of Tendering at a Glance

8

DIRECTORATE OF HEALTH SERVICES MADH YA PRADESH

No Q E q p O c t 7 7 Bhopal the 2 6 th October 1977

(E x t r a c t e d f r o m t h e G O and reproduced f o r 2 0 1 0 -11 to have clearity on process of

procurement )

To

The Deans

The Divisional Joint Directors of Health

Th e J o int Director of Ayurveda

The Administrative officer ESISIndore

The Superintendents of Medical College Hospitals

The Superintendents of Special Hospitals

The Civil Surgeons

The District Family Welfare cum Health Officers

The Principals RHFWTC

MADHYA PRADESH

Subject -Rules Orders for management of stores

The Government of Madhya Pradesh in the department of Public Health and family Welfare have by their order No 305847795-2877MedIII dated the 13 th

October 1977 issued Rules for the management of STORES These come int o force from the day they are received by the officer-i n- charge of an institution

It is desired that these Rules be followed strictly both in lsquoletter and spiritrsquo and no explanations would be accepted for non-compliance

Sufficient number of printed cop ie s a r e be ing se n t to you f o r d istr ibution a m ongst your subordinate staff concerned with the subject

A C Gaur For Director Medical Services

Madhya Pradesh

9

ACQUISITION OF STORES

The word Stores used hereunder applies generally to all articles expendable as well as dead stock of the nature of plant machinery instruments furniture fixtures medicines linen etc etc

Any authority which is competent to incur contingent expenditure may sanction the purchase of stores required (sub ject to his d e le ga tion of f ina nc ia l pow e r s) pr o vide d the following rules are observed-

(a) A Purchase Committee comprising of atleast three Gazetted Officers is formed for approving quantity and quality of stores required

( b ) An enquiry for the articles purch ased should be sent out to various manufacturers and dealers if the total of the order is for Rs 15000 or less In case the purchase order is likely to exceed Rs 15000 ldquoopen tendersrdquo be called through news paper publicity ( f igur e s p e r ta in to 1 977)

(c) Stores s h o u l d n o t b e p u r c h a s e d i n s m a l l q u a n t i t i e s and often if such store is not perishable

( d ) Requirement of the whole year to be worked out a nd n o stor e sh ould b e p ur c h a se d in e x c e ss o f the requirement

(e) P u r c h a s e s h o u l d b e m a d e i n t h e m o s t e c o n o m i c a l manner but q ua lity ne e d not be sa c r if ic e d in the interest of the economy

(f) The details regarding the quality desired and expected purchase quantity should be mentioned in t h e e n q u i r y

(g) Purchase order should not be split up to avoid the ne c e ssity o f obta ining th e sa nc tio n o f t h e h i g h e r authority

( h ) The date and time of opening of the tender should also be published and in case the tenderers desire to be p r e se nt o n th e o c c a sio n th e y should b e a llo w e d t o d o s o

( i ) Mere initialing on the covers of the tenders is not sufficient All the Purchase committee members s h o u l d s i g n o n e a c h a n d e v e r y p a g e o f t e n d e r q u o t i n g t h e r a t e s A n y r a t e s w h i c h h a v e b e e n overwritten by the tenderer should not be c o n s i d e r e d u n l e s s t h e y b e a r t h e t e n d e r e r rsquo s s i g n a t u r e and subsequently signed by a member o f t h e Purchase committee

( j ) A list of tenders opened should be made out and t a l l i e d w i t h t h e o n e o f t h o s e r e c e i v e d i n t h e o f f i c e Such a list should be signed by all the members of the Purchase committee

( k ) A comparative statement is then made and lowest t e n d er i s a c c e p t e d s u b j e c t t o q u a l i t y o f f e r e d b e i n g

10

satisfactory Samples of non perishable articles should be preserved safely under lock and key for comparison till the contract for supply is in force

( l ) R e a s o n s for rejecting the lowest tender and accepting the h i g h e r o n e s h o u l d a l w a y s b e r e c o r d e d in writing by the Purchase Committee

(m) No reason for rejecting the lowest tender need to be communicated to the tenderer

( n ) Every purchase order should clearly mention that the articles ordered shall be accepted subject to t h e approval of the Purchase Committee

( o ) Rules regarding deposition of earnest money and security money should be observed

( p ) For emergent purchases in public interest when there is no time to observe Store Purchase Rules purchases should be made up to Rs 2 5000 (refers to year -1 9 7 7 ) a t a t i m e A s f a r a s p o s s i b l e t h i s practice should be avoided

II PLACING OF ORDERS (a) For medicines and such other articles which the Medical Stores Depot Bombay

supplies order be placed with them at a specified time ( b ) For articles not on the Bombay Stores Depot Bombay lsquolimitedrsquo or lsquoopenrsquo

tenders be invited as the case may require It would be preferable to place orders on the manufactures or their authorized distributors

(c) For placing the orders on PSUrsquos Laghu Udyog Nigam or Organisations approved by the State government no tender needs to be invited

( d ) Price preference upto 10 is available to Small Scale Industries of this State only(not applicable as per New drug policy 2010 -1 1 )

III RECEIPT OF STORES All materials received should be examined counted measured or weighed as the

case may be when the delivery is taken The stores thus verified be may be immediately entered in the stock register Book under proper headings and this fact should be recorded on the body of the bill mentioning the page number of the Stock Book It should also be mentioned whether the quality and the quantity are correct as per the requirement Soon after the receipt each item be stamped with the initials of the institution

IV CUSTODY

(a)The head of the institution should ensure suitable accommodation for keeping the stores with a view to prevent losses through theft accident fraud or otherwise

(b) Separate Stock Accounts should be kept of-( i ) D e a d S t o c k-such as plantmachineryfurniture equipmentinstruments

etc (ii) Expendible items such as medicineslinenrubber goods etc (iii) Perishable articles

(c ) all recepts and issues in the stores stock registers should be on the authorityand under the signature of a respon sible officer deputed for the purpose

11

V ISSUE OF STORES (a) When materials are issued from stock the officer -i n ndashcharge should ensure that the indent is in proper proforma (Annexure A) and the person taking delivery is an authorized one (b) The issue vouchers (Annexure B) for articles should be prepared in triplicate by one single stroke of pen The first copy will remain with the records of the stores The second and third copies will go to supplies The second copy will be retained by the person receiving the supplies and the third copy will be returned by the receiver to the stores after making entries of hisher stock book page number etc against each item ( C ) E v e r y t i m e i s s u e b e r e c o r d e d i n t h e s t o c k b o o k o f t h e s t o r e s w i t h s i g n a t u r e s o f t h e O f f i ce r i n -charge

(d) Every issue made from the Central Stores to other institution should show cost of article preparation of Annual Stores Account at a later date

VI Maintenance of Stock Books (a) Stock book should be kept under the charge of a responsible person and should be

saved from loss and destruction ( b ) While making new entries in the main Stores Stock book cost of each item

should be entered though this need not be done in the case of registers in Wards Operation Theatre Out door etc

(c) There should b e n o o v e r-writing or interpolation or smudging of figures Any f i g u r e i f i t i s t o b e c o r r e c t e d s h o u l d b e c l e a n l y c u t a c r o s s a n d t h e n e w f i g u r e should be written by its side or below it under proper attestation

( d ) Stock books should always have a page count(each page be numbered) A certificate showing the number of pages be given on the first and the last page under the signatures of a Gazetted Officer

(e) Receipts issues and balances should be worked out for every item and attested regularly by the Offic er-i n -Charge of the Stores

(f) In the receipt column details regarding the size quality and any special features if t h e r e b e s h o u l d b e r e c o r d e d e g i n t h e c a s e o f A l m i r a h i t s s i z e a n d w h e t h e r i t i s of Steel or Wood

(g) In the Stock-book of library Edition and the ye a r o f p ublic a tion of th e book should always be mentioned

( h ) In case of medicines having an expiry date a list of such medicines be made out and should be checked every week Two months prior to the date of expiry if the s t o c k i s s t i l l f o u n d s u f f i c iently high intimation should be given to Directorate of Health

(i) N o r e m o v a l o f d e a d s t o c k s h o u l d b e m a d e f r o m t h e s t o c k ndash B o o k u n l e s s s o a u t h o r i z e d b y t h e c o m p e t e n t A u t h o r i t y

(j) While making a new Stock book and transferring the stocks therein it should ensured that the page number of the old stock book is shown in the new stock b o o k a n d s i m i l a r l y p a g e n u m b e r o f t h e n e w s t o c k b o o k i s m e n t i o n e d i n t h e o l d one This has to be done to facilitate cross checking whenever desired

( k ) T h e r e h a v e t o b e d i f f e r e n t s e t s o f proforma for dead stocks and for expendable items

Annexure ldquoCrdquo is for former and Annexure ldquoDrdquo for the latter varieties

12

VII PROCEDURE OF INDENTING FOR WARD amp OTHER SECTIONS OF THE INSTITUTION

(a) There has to be an Indent Book with every such section wh ich receives and issues medicinesequipment

( b ) The indent shall be prepared by the nurse Compounded -i n -c ha r g e of th e WardSection in te single copy on the Performa (Annexure A)

(c) The indent so prepared will be signed by the medical officer resident ndash i n c h arge or in his absence by a doctor senior to him but associated with the ward section

( d ) The indent shall then be signed by the head of the institution (Superintendent or the Civil Surgeon as the c a se ma y be ) o r b y his A ssista n t if th e la tte r is so authorized in writing

(e) The indent book is then presented to the main Store for effecting issue (f) The Store will then prepare issue vouchers (Annex B) in triplicate as directed

in Paragraph V (b) supra The supplies and the Indent Book are taken back by the Ward Section- i n - charge after signing the first copy of the issue voucher

(g) Te supplies after arriving in the WardSection shall be entered on the WardSection stock register which is prepared on a proforma (Annexure E) and page number of each entry be shown o n t h e 2 n d a n d 3r d copies of the Issue

voucher The 2 n d copy of the voucher is to be retained in a file in the wardsection but the 3r d c o p y s h o u l d b e r e t u r n e d t o t h e s t o r e b e f o r e s u b m i t t i n g a fresh indent The Store has to be maintain separate files of the 3 r d copies Wardsection-wise

VIIIHOW OFTEN TO INDENT

(a) A wardsection ndash i n -charge should work out an average weekly expenditure of each item and efforts be made to replenish the WardSection stocks every week

( b ) T h e M a i n s t o r e i n o r d e r t o a v o i d h e a v y rush of work should fix a day of issue for each major specialty T w o or th r e e minor spe c ia ltie s c a n be gr o upe d f o r one day

IX EMERGENT INDENT It is very likely for unforeseen reasons either the weekly indent of WardSection stock might get exhausted earlier or something which was not there in the lsquoweekly indentrsquo is required Under such circumstances an ldquoEmergent Indentrdquo could be made out in the usual manner but under the signature of the Unit-i n- chargeconsultant and it must be countersigned by the head of the institution (and not by his assistant) These supplies have also to be entered in the wardSection stock books like others

13

X HOW TO INDENT

(a) The ward Section -i n - c h a r g e s h o u l d e n s u r e t h a t t h e s t o c k s u n d e r t h e i r c h a r g e a r e not unnecessarily large and only a realistic quantity is indented once a week

( b ) The indent should not be made out in the names of the patients or by bed numbers The indent should be for the Wardsection as a whole

XI KEEPING OF RECORDS IN WARDS AND SECTIONS

(a) A set p r o f o r m a ( A n n e x u r e E ) s h o u l d b e u s e d i n t h e w a r d s e c t i o n f o r s h o w i n g u p receipts and issues Balance of expenditure for each item to be drawn out every morning by nursecompounder in charge before writing out the Indent or before restarting work The medica l O f f ic e r r e side nt in c ha r g e sh ould a tte st th e e ntr ie s after satisfying himself- by random checking at least once a week

( b ) To support the above mentioned expenditure the Bed head Tickets (treatment charts) are very important Each medicine prescribed should be legibly written indicating the total quantity prescribed if the medicine is to be deleted from treatment the fact should be mentioned as to how much of the drug was issued to the patient before switching on to another drug The suggestion is that a separate treatment card be maintained for each indoor patient ( Annexure ndash G) A summary s h o w i n g t h e t o t a l a m o u n t o f t h e p r o p r i e t a r y d r u g s c o n s u m e d b y t h e p a t i e n t d u r i n g is hospital stay be worked out and noted in the summary card

XII ACCOUNT ABILITY OF DRUGS BROUGHT BY THE PATIENT OR RECEIVED IN DONATION BY THE WARDSECTION _IN -C H A R G E

The drugs receoived from the non - governmental sources should be entered on the receipts side of the WardSection Sto c k b ook a n d issu e s to show n a s in th e o the r cases on the issues side

XII RSPONSIBILITY OF STORES AT VARIOUS LEVELS (a) The head of the institution shall be held responsible for non-observance of

rulesprocedures laid down by the Government ( b ) The Medical officerresident in charge of the stores and the store keeper shall be

held responsible for any irregularity found in the stores or for ignoring the ordered pattern of working It shall be the duty of the Medical officer Incharge of the Stores to occasionally check the WardSection Stock-b o o k s t o t a l l y t h e e n t r i e s made in the 3 r d copy of the Issue vouchers [as laid down under V (b)supra ]

(c) The Medical officerresident in charge of the WardSection shall be responsible for irregularities in indenting stocksfor maintaining stocks much in excess of the req uirement and for improper keeping of BED HEAD TICKETS (treatment chartsCards)

( d ) The NurseCompounder ndash i n -charge of the WardSection shall be responsible for shortages in stocks for putting up inflated indents and or for not taking into account medicines b rought by the patientson the WardSection stock-books Heshe shall also be held responsible for ensuring proper distribution of medicines to each and every patient under his her charge

XIV DISTRIBUTION OF MEDICINES FROM OUTDOOR DEPARTMENT (A) ( a ) T h e r e are proprietary and non -proprietary medicines (like mixtures ointments

and lotions) which are to be distributed gratis to patients 14

(b) The Outdoor incharge shall arrange to maintain a stock of common drugs (list of which shall be prepared by the Head of t he Institution) and arrange to replenish the stocks once a week as has been laid down for wards (c) No proprietary drugs shall be issued on the prescription of an intern ( d ) The Head of the institution shall make out a list of drugs which can be issued on

the prescription of a houseman from the Outdoor stock without the countersignature of any other authority

(e) The residents can prescribe any drug from Outdoor stock without the counter signature of any authority

(f) The Consultants can prescribe any drug to any ot h e r o u t e r p a t i e n t e v e n i f i t i s n o t s t o c k e d i n t h e o u t d o o r b u t t h i s s h a l l h a v e t o b e c o u n t e r s i g n e d b y t h e h e a d o f t h e institution for issue from The Main Store

(B) T h e p e r s o n i n c h a r g e o f t h e O u t d o o r m e d i c i n e s s t o c k s h a l l k e e p a r e c o r d o f t h e q u a n t i t y o f t he medicines issued to each patient and instead of writing the name and other details e may only put down the Registration number of the patient and the quantity issued

At the end of the day he must work out the total expenditure of eac item and draw it s balance

The Medical officer in charge of the Stores and the Head of the institution sould check these records at least once a week and affix is signature to confirm their inspection

(C ) No proprietary medicine shall be issued without a valid issue s l i p ( A n n e x u r e- F)

(a) For Housemen the slip would be of brown colour ( b ) For residentsDemonstrators it shall be of pink color (c) For consultants the issue slip should be white ( d ) All issue slips should be printed and pages serially numbered (e) T h e d o c t o r s t o w h o m s u c h i s s u e s l i p s w o u l d b e i s s u e d s h a l l b e h e l d

responsible for their sa f e ke e ping a n d th e y w ould e n su r e tha t th e se slip s would be printed and serially numbered

(f) The doctors prescription slips (for issue from hospitals) of proprietary drugs be prepared in du plicate with the help of carbon One copy should be given to patient for obtaining medicines from the Stores and the other would remain in the Doctors Prescription Slip book

(g) Every issue Slip should be signed and below the signatures a rubber s t a m p s h o w i ng name and designation be affixed The Store people would n o t h o n o u r s l i p u n l e s s t h e n a m e o f p r e s c r i b e r i s c l e a r a n d h i s a t t e s t e d signatures are available to stores

( h ) The Store Staff would file prescription slips of each doctor separately to facilitate the scrutiny at least once a month by the Head of the Institution Such a Scrutiny would reveal over prescribing of or injudicious use of drugs

(C) Proprietary medicines should not be issued for more than three days requirement at a time The only exceptions being cases for cancer pulmonary tuberculosis and leprosy In exceptional cases an officer not below the rank of a Consultant can prescribe for more than 3 days but after the countersignatures of the Head of the Institution

15

XV LOSS BREAKAGE DAMAGE ETC

(A) Any loss of public money departmental revenue of receipts stamps stores or other property held by or on behalf of the Government caused by defalcation or otherwise discovered in an office or institution should immediately be reported by the officer concerned to the head of department through his immediate superior as well as to the Accountant General if the loss exceeds Rs 20000(fig of 1977) (for Proforma see Annexure I)even when such loss has been made good by the party responsible for it Such reports must be submitted as soon as possible and soon after suspicion arises that there has been a loss they must not be delayed while detailed enquiries are made

When the matter has been fully investigated further and complete report should be submitted of the nature and extent of loss showing the errors or neglect rules by which such loss showing the errors or neglect of rules by which such loss was rendered possible and prospects of effecting such recovery

The s ubmission of such a repot does n o t d e b a r t h e l o c a l a u t h o r i t i e s t a k i n g f u r t h e r a c t i o n which may be deemed necessary like handing over the case to the police

Every Government servant should realize fully and clearly that he will be held personally responsible for any loss sustained by the government through fraud and negligence on is part and that will also be held personally responsible for any loss arising from fraud or negligence on the part of any other Government servant to extent to which it may be shown that he has contributed to loss by his own action or negligence

A s s o o n a s s h o r t a g e i n s t o c k o r l o s s i s d i s c o v e r e d a p a r t f r o m r e p o r t i n g t h e m a t t e r a responsible officer should be deputed to investigate the matter

W h e r e t h e r e i s n o l i k e l i h o o d o f a d e l i b e r a t e t h e f t b u t l o s s i s a result of neglect onlythe loss should be made good by the person on whose charge or custody the article lost remained

(B) As soon as damage or breakage of Government property is detected certain steps mentined under should be undertaken-

(a) A p r o m p t t h o ro u g h i n v e s t i g a t i o n i n t o t h e c a u s a t i o n o f b r e a k a g e o r d a m a g e s h o u l d be undertaken by the doctor-i n -charge of the WardSection or by the Head of the Institution

( b ) The investigating officer should draw conclusions as to whether the breakagedamage has been a result of-

(i) C a r e l e s s a n d n e g l i g e n t h a n d l i n g ( i i ) Unpredictable action of the patient for whom the equipment was

being used (iii) Accidental ( i v ) Manufacturing Defect

A report is then prepared in duplicate by person in charge of the article under question on the lsquobreakage and loss proformarsquo (See Annexure H)

16

These reports have to be signed by the investigating officer and are to be then submitted to competent authority for suitable action One copy which is returned is to be kept with the Stock Register In cases where the b r e a k a g e o r d a m a g e i s o f s u c h b i g g e r d e g r e e t h a t s atis factory repairs are not possible a n d if suc h b r e a k a ge o r da m a ge is o f su c h a de gr e e that satisfactory repairs are not possible and if such breakage or damage has been caused-

( i ) B y a G o v t s e r v a n t because of negligent or careless handling cost of the article should be recovered from him and credited to the treasury (ii)On account of reasons mentioned above that is un predictable action of the patient accidental or manufacturing defectthe article could be written offsubject to powers delegated to the concerned for such purpose

(C )Shortages detected during biannual physical verification of the Storeshave to be dealt in a similar manner

(D) it shall be at discretion of the competent authori ty (who is empowered to write off the loss) to reduce the amount of recovery upto 50 of the cost of article provided that before arriving at such a decisionhe has taken into account the following points (a) Normal life span of the article under questi on (b) Period for which it has been in use (c ) Condition of the article at the time of loss or damage and (d) Whether it was on account of careless or negligent act or not

XVI PROCEDURE FOR WRITING OFF STORES

(a) When any Stores become unserviceable otherwise than in ordinary course or by fair wear and tear their value should be treated as loss to the Government and in such cases cost should be recovered from the person responsible for his negligence

( b ) A s t r i c t w a t c h s h o u l d b e k e p t o n t h e m e d i c i n e s w h i ch bear an expiry date and if there is no likelihood of their being utilized locally intimation of the fact should be sent to Directorate of Health services and also to all o t h e r d i s t r i c t s s i m u l t a n e o u s l y s o t h a t t h e y c a n b e p u t t o u s e b e f o r e t h e expiry date In the event such a course is not followed and the Government i s p u t t o l o s s c o s t o f t h e m e d i c i n e i n q u e s t i o n s h a l l b e r e c o v e r e d f r o m t e defaulter

(c) For declaring articles as unserviceable a Committee of three members should be formed in each officeinstitution This Committee should examine each and every article brought before it and should record full reasons for condemning them and also say how the articles condemned have to be disposed of-whether by sale (by public auction) or otherwise

I f t he local Authority is not competent to write off the articles condemned by the Committee it should send the proposal to the higher authority for suitable a c t i o n

17

In Institutions where there is only one doctor a list of articles to be condemned should be p r e p a r e d a n d o r d e r s o n i t b e o b t a i n e d f r o m t h e inspecting authority during inspection

While preparing any list of articles for condemnation details regarding the date of purchase date of receipt period during which it remained in use usual life of the article and its purchase price should be noted against each item

( d ) The condemned articles should not be struck off the Stock Register till the competent authority sanctions its write ndashoff Details of Authority under which the article has been written off should be mentioned in stock register

XVII DISPOSAL OF WRITTEN OFF ARTICLES

Articles like linen should be torn into strips 10cm width so that they could be burnt or given to Government Jails for making carpets

Items like bed -pans bowlsurine po ts etc should be crushed and kept for auction

Brass utensils have also to be crushed to destroy their shape and could be either auctioned or after inviting rates from several dealers could be locally sold to highest bidder

In case when condemned ar ticles have to be sold by public auction they should be stored safely and the Government Auctioneer be intimated In case he expresses his inability to undertake the auction the officer should proceed with the auction departmentally The sale proceeds in either case should be credited to the Treasury as miscellaneous receipts under the Proper head of account

XVIII PHYSICAL VERIFICATION (a) The stocks held by officesinstitutions in various sections should be physically

verified twice a yearin the months o f April and October ( b ) Checking should be done by an officer other than te one who holds the charge of

Stores (c) Verification should be done in presence of officer holding the charge of Stores ( d ) All discrepancies found during the verification should be properly investigated

and accounted for

(j) Any excess detected during verification should be entered in the Stock book as Receipts with the remark ldquo Excess found on verificationrdquo

(ii)any shortage should be noted in issues column of lsquo Issuesrsquo described as lsquoshortage fou n d o n v e r i f i c a t i o n rsquo

XIX ANNUAL STORES ACCOUNT This account should be prepared according to the instruction issued from the department from time to time This should account for the outgoing financial year on the following lines -(a) Cost of the articles under various heads on the last day of the previous

year 18

( b ) Cost of the articles under the various Heads Received during the year (c) Cost of various articles written off during the year under review ( d ) Cost of the articles on the last day of the year or on the firs t d a y o f t h e

financial year following

19

Annexure A WardSection Indent Register No Issued on

Name of institution Page Folio No

Serial no Name of Article Quantity in Stock

Quantity required

Prepared by Approved by Recd by Note-Indenting Officer to sign and affix seal with name and

designation below the last item to avoid additions in one strokeno issues to be made by storesif Issue vouchers of

previous Indent has not been returned back by the WardSection

20

Annexure B Issue Voucher No (printed number)

Supplied to Wardsection Date

Indent no

Serial no Name of Article Quantity in Stock

Quantity required SB No

Stores-in MO Resident in Sign of charge charge WardSection

NurseCompounder Prepared by Recd Approved by by

Note-Indenting Officer to sign and affix seal with name and designation below the last item to avoid additions in one strokeno issues to be made by storesif Issue vouchers of previous Indent has not been

returned back 1st copy-Stores 2nd copy -Wardsection3rd copy-Tobe reurned to sores with Stock book entries

21

Annexure C

STOCK REGISTER FOR DEAD STOCKS

SERIAL NO DATE OF RECEIPT

Article with description

No of pieces Cost Details of

Bill Signature No Disposed

Date of disposal

Manner of Disposal

with Authority

Value realised Signature

1 2 3 4 5 6 7 8 9 10 11 12

P r e p a r e d B y C h e c k e d b y A p p r o v e d b y

Date Designation Name of Institution

22

Annexure D

STOCK REGISTER FOR EXPENDABLE ITEMS Name of article

Date

From where

received with cost

Quantity Signature To whom issued Quantity Balance Signature

1 2 3 4 5 6 7 8

23

Annexure E

Receipt amp Issue Register for WARDSSECTIONS (one or more pages as per requiremnt for each medicine)

NAME OF MEDICINE RECEIPT ISSUE

DATE Quantity In Stock

Date of

Issue

Issued toMention Bed no amp

quantity (in bracket) (For

Outdoor cases give Regd No)

Balance Signature

24

Annexure -F

OUTDOOR FREE MEDICINE SLIP In Duplicate

Name of Patient Registered No Date

Sr no Name of Medicine Quantity

Seal amp sign of doctor

25

Annexure-G

TREATMENT CARD

WARD NO

NAME OF PATIENT BED NO DATE amp TIME OF ADMISSION DATE amp TIME OF DISCHARGE

DATE MEDICINES PRESCRIBED SIGNATURE

26

ANNEXURE -H

PROFORMA FOR BREAKAGE amp LOSS

NAME OF OFFICEINSTITUTION DATE PLACE

SRNO NAME amp

DESCRIPTION OF ARTICLE

COST DATE OF PURCHASE

REASON CAUSE OF BREAKAGE

RECOMMENDATION OF INVESTIGATING AUTHORITY

Signature

Orders of the Competent Authority

Signature

27

Annexure ndash I Loss- Procedure for Reporting

1 The exact nature of the defalcation 2 The full extent of loss 3 The actual period covered by the defalcation 4 The defects in the negle c t o f r u le s by w hic h the loss was rendered possible

and circumstances which facilitated the defalcation 5 The names of the officials held personally or technically directly or

indirectly and wholly or partially responsible for the irregularity c o m m i t t e d i n t h e c a s e

6 Whether the c a s e a s b e e n J u d i c i a l l y t r i e d i n a c o u r t o r n o t i f s o c o p i e s ( i n duplicate) of the Judgment may please be furnished Copy of police report may also be furnished

7 The remedial measures adopted as safeguards against the losses hereafter 8 The prospects of re covery of the loss and he action taken to effect

recovery together with the amount recovered 9 Head of Account to which the Loss is debitable may be informed

Signature of Head of Office with seal

NoteA copy of this report is to be sent to AGMPThis is as per M P Finance Code Vol I

28

STORAGE AND STOCK MANAGEMENT

29

Foreword

The New Drug Policy 2009 is being implemented in the State of Madhya Pradesh

In order to have a proper procedure for Storage maintenance and expiry management of the drugs it is necessary to follow Good Storage Practices with Standard Modules for pharmacistStore keepers

Proper guidelines on Storage Practices can lead to better Stores and inventory upkeep with medicines being properly stored in racks with proper cleanliness and hygiene

This is a step towards storage maintenance and expiry management at the various stores in the state Looking forward to see that the heads of all health facilities take benefit from this module

D ir e c t o r M e d i c a l S e r v i c e s

30

INDEX

Sr No P a r t i c u l a r s P a g e

1 S T O R A G E A N D S T O C K M A N A G E M E N T 4

1 Quarantine and checking of stocks 11 Quarantine area 12 Checks to be carried out on new stocks

2 S t o r a g e 21 Need for proper storage 22 Different patterns of storage 23 Different means of storage 24 Temperatureclimatic conditions 25 Special storage of supplies 26 Storage and stability of medicines

3 Stock Control and Expiry Monitoring 31 Stock control 32 Stock rotation and expi r y m o n i t o r i n g

4 Other aspects of storage 41 Design of a storage area 42 Cleaning and maintenance 43 Product recalls 44 Returned goods

2 A p p e n d i x 1 Templates of letters for use if found not of Standard Quality [Frozen and expired goods ]

Frozen Drugs-ordered to return to the Suppliers-reg(New drug policy 2009)

Frozen Drugs-ordered to return to the Suppliers- for issue of gate pass after verification reg(New drug policy 2009) Stop instruction-reg(New drug policy

2009) Appendix II Material handling in drug stores

31

3 PROCUREMENT ndash Government Order Relating to

the Management of Stores

(Reproduced for reference material on basic

procedure in decentralized system followed by

Health facilities in 1977)

54

F L O W C H A R T S f o r a BI R D S E Y E V I E W o f

P R O C U R E M E N T

5 5

ACQUISITION OF STORES 6 1

PLACING OF ORDERS 6 2

RECEIPT OF STORES 6 2

CUSTODY 6 3

ISSUE OF STORES Maintenance of Stock Books

6 3

PROCEDURE OF INDENTING FOR WARD amp OTHER SECTIONS OF THE INSTITUTION

6 4

HOW OFTEN TO INDENT 6 5

EMERGENT INDENT 6 5

HOW TO INDENT 6 5

KEEPING OF RECORDS IN WARDS A N D S E C T I O N S

6 6

ACCOUNTABILITY OF DRUGS BROUGHT BY THE PATIENT OR RECEIVED IN DON A T I O N BY T H E WARDSECTION _IN - CHARGE

6 7

RESPONSIBILITY OF STORES AT VARIOUS LEVELS

6 7

DISTRIBUTION OF MEDICINES FROM OUTDOOR DEPARTMENT

6 7

LOSS BREAKAGE DAMAGE ETC 6 8

PROCEDURE FOR WRITING OFF STORES 6 9

DISPOSAL OF WRITTEN OFF ARTICLES 7 1

FORMATS TO BE USED 7 3 - 81

32

STORAGE AND STOCK MANAGEMENT The expiry periods of pharmaceutical products have meaning only if the products are stored under proper conditions otherwise products are likely to lose their potency before the actual date of expiry

A pharmacist is a vital link in the distribution chain for pharmaceutical products The medicinal products remain for a long period during the distribution cycle at the wholesaler and at retail pharmacies It is therefore very important to maintain proper storage conditions in these units

Every community pharmacy however large or s mall needs to store and manage its medicine stocks effectively There must be systems to ensure

middot bullbull Secure storage middot bullbull Clean and correct environmental conditions during storage middot bullbull Accurate and effective record keeping middot bullbull Effective stock rotation and expiry monitoring middot bullbull Effective fire and theft prevention middot bullbull Effective rodent pest control

For easier un derstanding this module has been divided into the following sections

1 Quarantine and checking of stocks 11 Quarantine area 12 Checks to be carried out on new stocks

2 S t o r a g e 21 Need for proper storage 22 Different patterns of storage 23 Different means of storage 24 Temperatureclimatic conditions 25 Special storage of supplies 26 Storage and stability of medicines

3 Stock Control and Expiry Monitoring 31 Stock control 3 2 S t o c k r o t a t i o n a n d e x p i r y m o n i t o r i n g

4 Other aspects of s t o r a g e 41 Design of a storage area 42 Cleaning and maintenance 43 Product recalls 44 Returned goods

33

1 QUARANTINE AND CHECKING OF STOCKS

11 Quarantine Area D r u g S t o r e pharmacies receive stoc k s f r o m su pplie r s a c c or d ing to pur c h a se o r d e r s T he stock that is received must be visually checked for quality and quantity The stocks must be kept in a separate area until the checking is done to avoid intermixing with existing stock This necessitates the presence of a separate area within the pharmacy w h e r e i n t h e storage and other checking of stocks can be performed This area is called the QUARANTINE AREA This area should be marked and identified adequately to distinguish it from other areas

The area may be marked using different means 1 ) A s m a l l board saying Quarantine on a separate table used exclusively if it is in the middle 2) A board on the wall if the table on which the quarantine stock is placed is against the wall

middot Stock received from wholesalers should be immediately transferred t o t h e Quarantine Area

middot In the Quarantine area the stock may be stored on racks shelves or in cupboards to prevent ingress of moisture dirt and other contaminants

middot Regular stocks from the pharmacy should not be left kept in the quarantine area Special care has to be taken in case of refrigerated medicines supplied by the suppliers so tha t the y do not remain in the quarantine area for long periods of time They should be immediately checked on receipt and transferred to areas for refrigerated storage s o a s to maintain the cold chain bull

Advantages of having a separate Quarantine Area middot Avoids cross mixing of newly arrived stock from existing stock till it is checked middot Lays stress on checking the quality of the stock received middot S to ck checking ensures t hat defective andor expired goods do not enter the storage areas

34

bullbull

bullbull

12 Checks to be carried out on new stock

Unpacking and checking stock

Supplies received should be unpacked and checked in the quarantine area Staff doing the checks should be adequatel y trained in what they have to check when stock arrives

Checking should be seen not simply as counting the units received but as a part of the quality assurance system bullThis should include middot Visually inspecting the packaging middot Checking the integrity of containers middot V erifying the completeness and leg ibility of la b e ls ( a ppr o ve d dr u g name strength any special storage instructions and expiry date)

bull

The expiry dat e should be checked to ensure that there is adequate shelf life remaining

Supplies should be individually checked using a checklist 35

Checklists

36

The wholesaler supplying the product should be notified immediately in case of any discrepancies ( and the details should be recorded in a register) and sent in a written format to the supplier It should include middot Missing boxes or cartons middot O p en tampered boxes or cartons middot Missing supplies middot Differences in the actual quantity and the quantity shown on the packing middot Additional medicines that had not been ordered but have been supplied middot D a m a g e d b r o k e n o r p oor quality medicines middot Any other discrepancies

The purchase invoices are an important aspect to be considered The invoiced documents should be signed and filed for reference as per the Drugs and Cosmetics Act and retained for at least 3years

If the wholesaler supplies medicines as an emergency without a bill or against a delivery challan

middot The supplies should be checked for integrity and inspected for damage middot The details of supplies received should be recorded middot The supplier should be asked t o send the bill as early as possible middot When the bill is received it should be checked against the details recorded and anomalies if any should be reported to the supplier

To keep a track of the received stock maintaining a S t o c k R e c o r d C a r d c a n b e very useful The entries in the stock record card can be made while checking the stock received STOCK BIN in the stores should have Stock record card

Maintaining a stock card for every product may not be very practical for a retail pharmacy however it could be maintained for costly medicines Nowadays it is much more practical and easier to maintain records using computers

The pharmacist should ensure that medicines manufacturedmarketed by a company are received only through an authorized distribution network of that company This is important to prevent spurious and counterfeit drugs from entering the pharmacy

37

2 STORAGE 21 The need for proper storage The storage of medicines and other products is an important requirement of Good Pharmacy Pr actice Appropriate storage of medicines is essential -

middot bullTo ensure that the potency is maintained middot bullTo prevent deteriorationspoilagedegradation middot bullTo ensuremaintain physical integrity

To ascertain that the quality and safety is maintained throughout their shelf life Storage requirements need to be considered on 2 aspects

a) Integrity of medicines Medicines should be stored in such a way so as to maintain their integrity and potency middot Maintain the right temperature required middot Protect from excessive humidity middot Keep medicines away from direct sunlight middot Protect from pests and rodents

b) Physical location middot Should be easy to locate middot Accessible middot Orderlysystematically placed

2 2 D i f f e r e n t p a t t e r n s o f s t o r a g e The pharmacist could follow any of the different patterns of storage The pattern of stora ge should be selected in such a way that it facilitates speedy and efficient dispensing of medicines

The pattern of storage could vary with each pharmacy experience usual practiceroutine of staff and the person-in charge and also depending on space av ailable turnover etc (i) The medicines could be stored c o m p a n y w i s e ie the medicines manufactured by one company should be grouped together and kept in one place Within each company shelfshelves the medicines may be placed in alphabetical order for easy and quick placement and removal Also bottles tubes boxes etc may be segregated within that shelf

38

(ii) The medicines may also be stored in a lphabe t ic al o r de r ie they are placed in order from left to right based on their name The first letter of the name is used to g r o u p t h e m e d i c i n e s t o g e t h e r a n d k e e p t h e m i n o n e l o c a t i o n I n s o m e p h a r m a c i e s a l l t h e strip packing are placed in drawers or boxes in alphabetical order each box or drawer containing strips of one particular alphabet This system ensures that the strips always remain e n c l o s e d i n t h e b o x e s d r a w e r s a n d a r e n o t e x p o s e d t o d u s t T h e d i s a d v a n t a g e i s that it might lead to mix -u p o f strips in the same drawer and it may cause a problem incase of similar looking strips in which case a wrong medicine may be dispensed Secondly cut strips lying around in the drawer may lose their identity if the batch n u m b e r andor expiry date is not seen on the cut portion of the strip

39

(iii) The medicines may be stored according to their therapeutic class ( e g a n t i b i o t i c s anti asthmatics or anti hypertensives) ie the medicines are kept together based on their pharmacological or therapeutic action

(iv) The medicines may be stockedsegregated according to dosage forms eg l i q u i d s (bottles) solid oral dosage forms eye drops rotacaps ointments etc all stored on separate shelves

Always Remember I Storage of prescription medicines should preferably be separate from OTC medicines OTC medicines especially those that a r e a d v e r t i s e d m a y b e d i s p l a y e d f o r c l i e n t s t o select or to ask questions about [OTC-O v e r t h e c o u n t e r ] II Storage according to temperatures is a must no matter which pattern of storage is followed Also within a particular storage area segregated storage may be maintained In a refrigerator for example medicines may be stored in trays racks and the freezer according to the temperature required

40

Whatever pattern of storage is selected all the personnel should ensure that middot The stocks are stored in an orderly manner middot The medicines are kept back in the same place from where they were removed middot All medicines are arranged neatly once in a while

middot The personnel should be careful while storing the medicines middot They should not throw the medicines haphazardly 23 Different means of storage

middot Within each temperature and security zone medicines must be stored so that they are easily accessible and protected against damage

middot Basic means of storage include shelves racks and drawers middot To prevent dust from entering the shelvesracks it is ideal to have glass

shutterssliding glass doors This can however be disadvantageous because accessibilityspeed is hampered in removing a product from the shelf because the glassshuttersliding glass has to be

41

opened m o v e d e v e r y t i m e a p r o d u c t h a s t o b e p i c k e d u p U s e o f a i r c o n d i t i o n e r s f o r t h e p h arm acy with a closed door at the e n t r a n c e o r a n a i r c u r t a i n c a n r e d u c e t h e d u s t problem In such cases the shelvesracks may be left o p e n

bull

middot Direct storage of cartons on the floor should be avoided because besides being an unhealthy practice the contents may also be damaged by moisture bull

middot Store medicines preferably in shelves with glass shutters for visibility middot Closed shelves further prevent dust from going in especially in India where most

pharmacies are located along busy roads middot Some medicines have to be refrigerated or stored in a cool or cold place Having a

refrigerator or two (as per the need of the pharmacy) is essential to store suc h medicines at temperatures mentioned on the label bull

42

Refrigeration middot All cold chain equipment should meet required standards middot Improvement in refrigeration technology has provided frost -free refrigerators

Pharmacists should opt for frost-free refrigerators as they are easy to maintain and protect printed packaging materials Conventional refrigerators may cause water falling from trays below the freezer on medicines stored in the refrigerator thus causing soggy labels

middot bull Frost-free refrigerators also provide separate and large compartments for the freezer portion (required for storing medicines needing sub-z e r o t e m p e r a t u r e ) and the main storage area with separate doors so that opening one door does not disturb the storage temperature in the other compartment

Care should be taken to keep the refrigerator on 24 hours a day It should not be switched off after working hours It is advisable to have an inverter connected to the refrigerator so that the refrigerator re mains working even when there is a power outage

middot The refrigerator door should be closed tightly middot The refrigerator door should not be left open for too long middot Space should be left between medicines stored in a refrigerator to allow air to

circulate middot The ref rigerator should be placed about an arms length away from the wall

This will increase air circulation thus not affecting the cooling within the refrigerator

middot Vaccines should not be stored on refrigerator door shelves as they are exposed to warmer temperatures each time the door is opened Vaccines should always be stored on the middle shelves of the refrigerator

middot Refrigerated medicines should not be left out of the refrigerator for more than a few minutes

43

middot Consumable products like juices energy drinks e t c s h o u l d n o t b e s t o r e d a l o n g with medicines in refrigerators If required they may be kept in a separate refrigerator

middot An adequate number of refrigerators should be planned to store the entire stocks requiring refrigerated storage

middot Adequate procedures should be followed for defrosting cleaning and maintenance of refrigerators

middot Icefreeze packs should be kept in the freezer compartment so that they can be used for transporting cold temperature medicines The packs can be given to clients along with the medicines requiring cold temperature storage so that the temperature is maintained till the client reaches home and can then put the medicines in a refrigerator) Freezer packs can also be used to keep medicines temporarily in case there is a power outage or refrigerator breakdown

Activity

Prepare a SOP (Standard operating procedure chart) for cleaning a refrigerator Discuss it with your staff finalize its maintenance once a month through AMC -A n n u a l Maintenance contract CMC - Comprehensive maintenance contract and put it up on the pharmacy refrigerator Put the Purchase Order details name of manufacturer Phone of Service Engineer and a register to login the Machine service and down timeService reports may be maintained properly

Refrigerator monitoring and maintenance

middot bullIt is important to carry out routine monitoring and maintenance of the refrigerators and to organize an effective repair system

middot bullThe temperature in the refrigerator must be monitored and recorded routinely at least once a day

middot Any breakdown must be reco rded including the period during which the medicines were exposed to uncontrolled temperatures Medicines may then be kept or discarded depending on the problem guidelines or the manufacturers advice

middot Cold chain monitor cards and devices in or on packages that change color or otherwise alert staff to potential damage assist in monitoring (These are likely to be introduced in India soon)

middot It is essential to have a contingency plan in place before a refrigerator breaks down An arrangement can be made to move the contents to a private refrigerator elsewhere in the community or to obtain a regular supply of ice packs until the defect is rectified

Put filled water bottles in the bottom half of the refrigerator door in order to provide cooling in the refri g e r a t o r w h e n t h e r e i s a p o w e r o u t a g e T h i s m i g h t t a k e c a r e o f t h e temperature when there is no current for a couple of hours If the power outage is expected to last for several hours special arrangements such as an inverter UPS have to be made to keep the refrigerator constantly running in the absence of electricity middot Defrost the refrigerator in case of excessive ice formation and preferably at regular

intervals Keep a record of the same

44

2 4 T e m p e r a t u r e c l i m a t i c c o n d i t i o n s

i) Temperature control middot The medicines in a pharmacy need to be stored at appropriate temperatures to

maintain their stability middot An air-conditioned environment where temperature can be controlled is

recommended for pharmacies Air conditioning offers the option of setting the t e m p e rature as per requirements

middot bullIt is ideal to have an air conditioner to maintain the temperature below 25 C as most medicines require storage below this temperature Secondly this temperature is pleasing to both the staff and the visiting customers too

middot In the absence of an air conditioner circulating fans may be used middot This need is felt even more in certain parts of India where temperatures soar above 45

C and some areas where it falls to sub zero temperatures In such cases temperature maintenance is essential to prevent deterioration of medicines due to unnecessary exposure to drastic temperature fluctuations

middot This need is felt even more in certain parts of India where temperatures soar above 45 C and some areas where it falls to sub zero temperat u r e s I n s u c h c a s e s temperature maintenance is essential to prevent deterioration of medicines due to unnecessary exposure to drastic temperature fluctuations

i i ) Humidity or moisture control Moisture or humidity can adversely affect the stability of me dicines such as tablets capsules powders

45

Gelatin capsules become soft and swell on absorption of moisture The drug content of tablets may undergo surface hydrolysis The presence of moisture may encourage the growth of microbes It is therefore essential to control humidity

To reduce the effect of humidity the following suggestions may be followed -middot Open the windows to allow air circulation Use a fan to circulate fresh (outside) air middot In humid climate a dehumidifier is useful for preventing mo i s t u r e d a m a g e ( i n t h e absence of an air conditioner) middot For bulk containers of tabletscapsules do not keep the container open for a long time and replace the lid or closure immediately after taking out the required number of medicines for dispensing middot Do not allow the medicines to touch the floor or the walls The walls may be damp and may cause moisture absorption damaging the product

middot Calibrated thermometers and manometers can be used to detect temperature and humidity in the pharmacy

middot Periodici t y of checking the temperature should be fixed middot The climatic conditions should be recorded and documented middot Temperature charts should be available for ready reference

Documentation is one of the core activities for achieving and maintaining quality It is one of the most essential components of validation Temperatures in various areas

46

including refrigerators should be recorded at a predetermined periodicity usually daily at the hottest time of the day and such documents should be preserved i i i ) Storage conditions A number of storage conditions are mentioned on the labels of medicinal products These conditions have to be properly interpreted and appropriately complied with

According to the Drugs and Cosmetics Rules 1945

1 The term cool place means a place having a temperature between 10 C and 25 C

2 The term cold place means a place having a temperature not exceeding 8 C In case of storage conditions for specific products please refer to Schedule P The Drugs and Cosmetic Rules 1 9 4 5

The Indian Pharmacopoeia specifies the following storage conditions -

Wherever the condition for storage is not specified medicines may be stored under normal temperature In a country like India however where normal temperatures soar to h i gh temperatures it is recommended that medicines be stored in a cool place

Activity Prepare a list of the storage requirements mentioned on the label of about 20 products in your pharmacy and check if the temperature is maintained

47

25 Special Storage o f s u p p l i e s If the product has no special instructions normal storage conditions apply This means storage in dry clean w e l l -ventilated premises at temperatures of +15 C to +25 C or depending on the climate up to +30 C (WHO1990) Storage instructions are product specific Different brands of the same generic drug may have different storage requirements as they may have different packaging or formulations It is essential to follow the product manufacturers storage instructions to the maximum extent possible Less stable medicines must be stored in specific conditions to maintain their quality or potency

The following products require special storage facilities

middot Products that must be kept frozen (usually vaccines and sera) middot Products sensitive to h eat an d r e q uir in g r e f r ig e r a tio n ( +2 C to +8 C) middot Products that have reduced shelf life at uncontrolled room temperature and need

mechanical ventilation or air conditioning middot Flammable products that require separate fireproof premises middot Products prone to theft o r m i s u s e

Products needing storage in a controlled environment -

The usable shelf life of the following products may be reduced if stored at uncontrolled humidity or at room temperature in hot climates -

middot Some injectables (eg adrenaline) Most injectable preparations are less stable than solid oral forms (tablets and capsules) Injectable preparations in solution are particularly unstable Many injections must be protected from light as well as heat

middot Intravenous fluids (particularly if packed in p lastic containers) middot Some suppositories pessaries creams and ointments These products may melt at

temperatures greater than 30 C Once this happens it is not advisable to use them because the active ingredient in the formula may get unevenly distributed

middot Products containing rubber latex cellulose or some plastics Condoms most sterile disposable medical devices and surgical products such as syringes needles and catheters require protection from excessive humidity and strong light and heat Any o f these conditions may make products brittle stained amp unusable Sterility cannot be assumed if packaging is damaged

In hot climates these products should be stored in the coolest place possible preferably with air conditioning or air circulation fans

48

Products needing freezing or refrigeration-middot Vaccines blood products and many other medicines lose potency if kept even for a

brief period at temperatures outside the recommended range For these products the cold chain must be maintained at every stage of the distribution system

middot Freezing is as damaging as high temperatures for some products including injectable contraceptives ergometrine insulin adrenaline and the DPT DT TT and Hepatitis B vaccines Such products therefore sho uld not be allowed to freeze (not be kept in the freezer compartment)

middot Short periods at room temperature (during transportation or local distribution for instance) may be acceptable for many products (such as ergometrine a n d i n s u l i n ) e v e n t h o u g h s u c h e x posure can to some extent reduce shelf life Other items such as vaccines should always be transported in cold boxes

Storage of insulin injections-

middot Insulin should always be stored in a refrigerator at the recommended temperature of 2 -8 C

middot Insulin should not be kept in the freezer compartment of the refrigerator middot Insulin should ideally be stored horizontally middot It should not be exposed to sunlight or excessive heat middot Insulin suspensions should not be used if the suspension cannot be properly

resuspended due to cake or clump formationbull

Controlled drugs -Narcotics (for example Pethidine injection morphine preparations) and other specified drugs that may be abused are governed by special legislation and regulations The following security measures are suggested in the pharmacy -middot A safe or reinforced double locked cabinet fitted with a light (preferably with a red

bulb) that comes on when the door is opened

49

middot A special register recording details of each receipt or issue with 2 signatures physi cal counting of medicines after each entry and signatures at handover takeover

middot Independent audit (by supervisors and drug inspectors)

Products prone to theft abuse or misuse -

Some medicinesproducts are particularly prone to theft abuse or misuse These include expensive medicines (eg insulin) certain antibiotics and products prone to abuse or misuse like psychotropics etc

Such medicinesproducts should be stored adequately They require stricter record keeping and more frequent stock taki ng than others Periodic audits should be carried out to check for consumption against actual recorded use (registers prescription records stock records etc) to expose any theft or misuse bull26 Storage and stability of medicines Medicines are not stab le indefinitely They are stable for a specific period of time sometimes for a brief period Poor storage conditions accelerate the drug degradation (decomposition) Temperature light and moisture are the most important contributing factors for drug instability It is important to identify and be aware of the potential for instability There is a need to comply with storage requirements to ensure quality medicines for patients It is also important to offer advice to patients too about appropriate storage o f medicines at home The dispensing label should state the storage condition required and be backed up by a verbal reminder especially where special storage is required bull

50

In case stability and storage problems are seen with formulations they should be reported immediately to the representative of the manufacturer and taken out of circulation till the stability problems have been resolved

The pharmacist can easily detect stability problems when products show change in appearance color odor settling of the product contents breaking of emulsions melting of creams oozing of contents from the containers and any such physical changes

3 STOCK CONTROL AND EXPIRY MONITORING 3 1 S t o c k C o n t r o l For economic reasons pharmacists do not like to have stock on their shelves for long periods of time The aim should always be to keep stock at a level that will just meet demand Normally most manufactured medicines have a long shelf life Even then it is essential that there is efficient stock rot ation so that the older stock is used first It is also a good practice to check the expiry date as an integral part of the dispensing process When short shelf life products are involved stock levels may have to be modified to prevent medicines regularl y expiring on the shelves

32 Stock rotation and expiry monitoring In order to avoid accumulation of expired and obsolete stock medicines should be stored and issued according to the following guidelines -middot The stock control system must record the ex p i r y d a t e a n d t h e d a t e o f r e c e i p t middot Stock must be stored so that earliest expiring batches are picked and issued first middot The First In First Out (FIFO) system - In this system the stock which is received

first is sold first This system however may not be useful for pharmacies because most of the stocks carry an expiry date For pharmacies the FEFO system is more practical

51

middot The First Expiry First Out (FEFO) system - In this system the stock having an earlier expiry is sold first The stock with longer shelf life should be placed farthest to the back (or at the bottom in case o f sta c k e d b oxe s) T h is is pa r tic u la r ly impor ta n t with products that have short shelf lives such as vaccines some vitamins antibiotics etc and reduces losses due to expiry

middot E x p i r y dates should be noted on the stock record upon receipt Stock nearing expiry should not be accepted unless it can be used before expiry

Computerization and expiry monitoring In the pharmacy computerization facilitates both checking stocks and expiry mo nitoring and helps-bullbullKeeping a check on products nearing expiry bullbullKeeping a check on non- moving and slow moving products bullbullTo facilitate the removal of medicines nearing expiry from shelves in time to send them back to the wholesaler or supplier

Periodic checking for expiry The expiry date for medicinal products is a critical aspect in pharmaceutical dispensing and due importance should be given to it Periodic checking for expiry of medicines will ensure that the patient will never receive products that have crossed their expiry date During periodical checking of expiry the personnel involved should remove medicines that are nearing expiry bullbullIn -house threshold periods should be set and followed for retrieval of such medicines from the shelves bullbullSuch medicines should be stored separately These should either be dispensed immediately (thus ensuring that they are used before the expiry date) o r t h e y s h o u l d b e returned to the suppliers bullbullA separate area should be designated (cupboard or shelf)marked[FROZEN ZONE] which is adequately marked EXPIRED GOODS- NOT FOR SALE to store all expired stocks FROZEN ZONE

52

Remember Expired medicines are a NATIONAL WASTE So stock only what you can sell Avoid expiries save precious medicines for the nation

Treatment and disposing of expired medicines bullbullProcedures need to be in place for the treatment of expired medicines bullbullThe expired medicines need to be collected and be sent back to the supplier or company for appropriate disposal bullbullRecords must be maintained for expired medicines and how they are disposed off bullbullIn case of medicines that are not returnable to suppliers procedures for disposal need to be followed by the pharmacy in conjunction with the FDA The following procedure can be followed if medicines cannot be returned to suppliers ( T h e b a s i c p h i l o s o p h y of appropriate disposal is to prevent their re- circulation and use) bullbullC u t t h e c o n t ainer in such a manner that the label is also cut In case of tablets and c a p s u l e s d e s t r o y them by disposing them in a bucket of water bullbullUse landfill procedures (deep burial into the ground as per stipulations of Medical Waste Disposal Act prevalent in the respective state) bullbullPour the liquids into the sink and wash away with sufficient quantity of water bullbullKeep a record of such disposal with full details of medicines destroyed Although these measures are usually adopted care has to be taken with such tr e a t m e n t a s studies have shown that flushing of medicines has resulted in tracessmall quantities of medicines being found in waterways and groundwater having potential health and environmental effects

4 O T H E R A S P E C T S 41 Design of storage areas The following important factors need to be considered in design of storage areas -middot The retail outlets in hot areas in summers should be air-conditioned Similarly in

a r e a s o f e x t r e m e c o l d t h e p r e m i s e s w o u l d r e q u i r e w a r m i n g e s p e c i a l l y i n w i n t e r s t o maintain cool temperatures The placement of air -conditioners and heating devices should be such that medicines are not directly exposed to the cold or heat

middot Due consideration should be given to storage requirements of formulations while designing shelves and cupboards in retail outlets Sufficient shelf height should be provided so that all liquid products can be stored vertically As far as possible the shelves should be covered with glass panels to protect medicines from dust and p r e v e n t r a p i d f l u c t u a t i o n s i n temperature

middot Medicines should be stored according to the storage instructions on the labels bullIt is ideal to have a door at the pharmacy entrance to prevent dust from coming in as well as reduceprevent cooled air from going out This may not however be considered feasiblepracticable by many pharmacy owners for fear that clients may not enter the pharmacy because the door may act as a barrier An air curtain is a good alternative to a door

middot There should be minimal direct sunlight falling on the products Particular consideration should be given to premises directly facing the sun

middot bullThe arrangement of lighting in the interior of the premises should also be in a manner that the lights are not focused on the products It has been shown that light causes not only chemical damage but also can catalyze physical changes like moisture uptak e by the products Care should be taken to ensure that only diffused light falls on them

53

middot As far as possible provision should be made for a temperature and humidity indicator device in a pharmacy These devices are now easily available

middot Stability studies o f m e d i c i n e s p a c k e d i n b l i s t e r s h a v e r e v e a l e d t h a t i f t h e s e a r e exposed to light they tend to absorb moisture It is therefore necessary to store them in suitable cartons so that the blisters are not exposed to light Pharmacists should do this even if the manufacturer has not provided cartons

middot Light and temperature sensitive products should not be stored on counters where the light is intense or direct and there is no protection from temperature and humidity

42 Cleaning and maintenance i) Cleaning of storage areas

The storage areas of the pharmacy should be cleaned periodically and cleanliness should be maintained at all times The Standard Operating Procedure for cleaning should be designed and followed accordingly Schedules for cleanups should be laid down and adequate cleaning equipment should be made available

Tips for maintaining cleanliness middot Provide clean pieces of cloth for wiping at various locations in the pharmacy

Replace with clean cloth at regular intervals middot Keep separate pieces of cloth for floors shelves and medicines middot Use a disinfectant andor soap solution to clean floors middot Ensure removal of dust and prevent accumulation of dirt middot Ensure removal of cobwebs middot Use a vacuum cleaner for cleaning areas not easily reachable middot T a k e c a r e t h at breakages are handled and cleared effectively middot Observe the factors leading to waste generation in the pharmacy and take appropriate

measures to tackle the problem middot Record all cleaning procedures performed and maintain all the documents required

For ex a m p l e -bullbullThe floor of the pharmacy may be swept with a broom and swabbed with soap water every morning bullbullThe floor may be swabbed with a disinfectant every week bullbullThe entire premises including shelves and cupboards may be cleaned with a cloth (to remove dust and to check for medicines approaching expiry date or expired medicines) every three months bullbullAll the steps followed should be r e c o r d e d

The floor shelves drawers have to be cleaned and a check should be kept on dust cobwebs spillages due to breakage etc It is therefore essential to have SOPs for cleaning laying down cleaning frequencies allotting responsibilities and maintaining a daily record in the logbook to document all these activities

54

While cleaning dust settled on dosage forms like bottles tubes etc should be removed Before dispensing the products should also be wiped to remove any dust settled during storage

For refrigerators bullbullDefrosting and cleaning should be done at regular intervals bullbullSwitch off the refrigerator while cleaning bullbullCleaning should be done quickly and stocks put back immediately

i i ) Pest control Pests are a serious problem in India where insects reptiles and rodents (eg cockroaches l i z a r d s r a t s s i l v e r f i s h (Deemak - in Hindi ) etc) may find access to the pharmacy storage areas Insects like ants and borer ants may often attack wood in the pharmacy causing d am ag e to shelves cupboardsPest c ontr o l in a p h a r m a c y c a n b e a d i f f i c u l t t a s k b u t t o avoid possible contamination and physical damage to stock it is necessary to keep pests out of the pharmacy premisesPest control measures should be implemented with proper p r e c a u t i o n s t a k i n g u t m o s t c a r e t o a v o i d contamination of medicines

55

Th e following pest control measures c a n be ta ke n f r om tim e to tim e -bullbullRat bait and traps can be placed at various locations bullbullInsecticutors can be used on a permanent basis bullbullInsecticidal sprays and repellants can be used from time to time

i i i ) Fire precautions

Combustible trash such as cartons boxes and other packing waste must not be allowed to accumulate in the store Waste should be deposited in appropriate waste bins and be d i s p o s e d o f f o n a d a i l y b a s i s

F i re detection and fire fighting equipment must be maintained and regularly inspected The pharmacy personnel should receive adequate training in fire fighting techniques and emergency actionFire prevention measures should include a prominently displayed ldquoNoSmokingrdquo sign careful handling and disposal of combustible waste materials and checking of electrical connections at regular intervals

iv) Security middot Doors shutters of the pharmacy should be strong and be fitted with secure locks middot Counters should be designed so that unauthorized personnelclients do not have

access to areas where prescription medicines are stored Access to such areas should be restricted to the pharmacy staff

middot All the pharmacy staff handling supplies should be accountable for their ac t i o n s

56

middot bullSpecial care must be taken in case of Schedule X and manufactured drugs (under NDPS Act) Such medicines should be kept under lock and key and the key should be kept with the Chief Pharmacist or i n h i s a b s e n c e t h e s e n i o r p h a r m a c i s t

v) Breakagespillage and damaged product Products that have been damagedspoiled during storage and handling spillages and broken glassware should be disposed off according to procedures laid down by the pharmacy Broken and damaged products s h o u l d b e p l a c e d i n a segregated area to be returned to the supplier

vi) Inspection Senior staff should inspect all pharmacy areas regularly The shelves and drawers should b e c h e c k e d d a i l y f o r signs of pests and dust Ceiling and walls should be checked for dirt and cobwebs Stock should be checked on a regular basis for deterioration due to climatic conditions

43 Product recalls Products found to be defective should be quickly recalled (withdrawn from the market) The instructions are generally issued either by the manufacturer or the regulatory agency The level of recall is determined by both the degree of risk and the extent of distribution of the product and in India is mainly directed at the distribution chain

On receiving the details of the defective substandard spurious batchbatches of a medicine to be recalled from the manufacturer or the stockist or the FDA the pharmacy should immediately check if the particular b a t c h i s i n s t o c k a n d i f s o s u s p e n d i t s s a l e immediately

Similarly if the regulatory authority in the country bans a particular medicine or FDC the pharmacy should immediately check and remove all the different brands of that particular medicine under consideration

The details of medicines and their batches to be recalled should be available in the q u a r a n t i n e a r e a w h e r e stocks are received and checked This is to ensure that such medicines do not come into the pharmacy

middot The pharmacy should develop SOPs for recall of medicines middot The pharmacy staff should be immediately informed about such medicines and

the details should be displayed in writing in a prominent place in the pharmacy middot Rapid action helps avoid unnecessary exposure to such medicines once the

problem has been d e t e c t e d middot The progress of the recall procedure in the pharmacy should be monitored every

few days to ensure complete compliance middot All stocks of the recalled products should be stored separately from the saleable

stock These can be stored in the expiry cupboard segregated from the expired goods and be appropriately labeled ldquoRecal l e d G o o d s - Not for Salerdquo

The supplier should be notified and asked to replace defective products middot All the details of the procedures followed should be duly recorded in a Recall

Register maintained specially for the purpose The register should include d etails such as -middot Date of the recall middot Nam e of the product

57

bullbull

middot Details of the product (name of manufacturer batch number expiry date) middot Nu m b er of units purchased sold a n d sto c k in ha nd middot Reason for recall middot Nam e of the supplier to whom produc ts w e r e returned along with the date and quantity middot Name and signature of the designated personnel carrying out the recall procedure and recording details middot Name and signature of the chief pharmacist verifying the recall procedures and recording details 4 4 Returned medicines

Medicines may be returned to the pharmacy by clients due to the following reasons -bull

bullbull Unused medicines bullbull Course not completed bullbull Therapy changed by doctor bullbull Side effects experienced by patient bull

bullbull DamagedDefective medicines bullbull Missing or defaced label bullbull Missing tablets in a stripblister bullbull Leakage in bottles bullbull Leakage in strips bull

bullbull Expired medicines

Appropriate SOPs should be framed and followed for their acceptancerefusal and disposal middot bull For unused medicines returned by clients the p harmacy personnel should verify

that these were purchased from their pharmacy They should then be checked for integrity of the packing the dosage form and the expiry date and verified with the client whether they were stored in appropriate conditions This again is at the discretion of each pharmacy

middot The damageddefective medicines returned to the pharmacy should be taken back and stored separately Existing stock of the same product should be checked for similar defects

middot Expired medicines should be accepted from clients at the discretion of the pharmacist and be immediately shifted to the expired goods cupboard These can be stored segregated from the pharmacys own expired goods and be appropriately labelled ldquoExpired Goods returned by clients- Not For Salerdquo

It is advisable not to accept returned medicines requiring cold chain storage (refrigeration) because it cannot be ensured that the cold chain was maintained when the medicines were in the hands of the patientclient middot Appropriate adjustments in t he stocks should be made for medicines

returnedexchanged to update the inventory middot The medicines should then be returned to the respective shelves middot A lsquoReturned Goodsrsquo register needs to be maintained to record all details of returned

medicines

R egister should include such details as-

58

middot N a m e o f t h e p a t i e n t middot Nam e of the product and quantity r e tu r n e d middot Product details such as the batch number and expiry date middot Condition in which received middot Reason for returning products middot Compensatory measures taken wi t h r e s p e c t t o c l i e n t middot Action taken with respect to product middot Name and signature of the personnel accepting the returned medicines and recording details middot Name and signature of the chief pharmacist verifying the recorded details

What the pharmacist would have learnt from this module The storage of medicines is a critical factor in the distribution cycle bullbull Stocks received by the pharmacy should be quarantined in a separate area and necessary checks s h o u ld be performed to ascertain the qua lity a nd quantity of stocks received bullbull Whatever pattern and means of storage used the products should be stored so as to maintain their potency and integrity bullbull Storage conditions should be monitored and maintained on a regular basis bullbull Optimum stock levels should be maintained and regularly monitored for expiry bullbull The design of storage areas should facilitate appropriate storage of medicines bullbull Cleanliness should be maintained in the pharmacy bullbull Adequate measures should be taken in case of returned medicines and recalled products

Optimum storage of medicines is mandatory whether at the distribution stage at the pharmacy or ultimately within the homes of patients The pharmacist has an important r o l e t o p l a y i n t h e s t o r a g e o f m e d i c i n e s i n m a i n t a i n i n g d r u g p o t ency and efficacy and thus facilitating optimum therapeutic benefits Good Pharmacy Practice - IPA -CDSCO - WHO Appendix I Quality Assurance Templates of letters for use if found not of Standard Quality [Frozen and expired goods ]

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated To Name of the Supplier with address

Sub Not of Standard Quality GoMP-Supply of Drugs and medicines-(Codename) Return of Stocks to the Suppliers-reg(New drug policy 2009) Previous letterinvoice ref Sl No Drug Code Drug name

Manufacturing date Expiry date

Supplier address

B a t c h n o

The above items of PO nodated was drawn by the Drug Inspector (Place) on (______________date) as a statutory sampling and declared ldquoNot of Standard

59

Qualityrdquo on -(______________date) by the Government Analyst for the following reasons

- ldquoThe product sample do not confirm to IP specification for (Drug codename with respect to the content of drugrdquo

- ldquoThe product has already been blacklisted by TNMSC on -(______________date) for the failure of (quantity) of batches of drug codenamerdquo

As per the clause of the te nde r d oc um e nt ldquo I f the sa mple s d o not c onf o r m to statutory standardsthe tenderer will be liable for relevant action under the existing laws and the entire stock in such batch should be taken back by the tenderer within a period of 30 days o f t h e r e c e i p t o f t h e l e t t e r f r o m t h e v e n u e

The stock shall be taken back at the expenses of the tendererthe Procurement Authority have the right to destroy such Not of Standard Quality if the tenderer does not take back the goods within the stipulated time

The Procuring Authority will arrange to destroy the Not of Standard Quality drugs within 90 days after the expiry of 30 days mentioned above without further notice and shall also collect demurrage charges calculated at the rate of 2 per week on the value of the drugs rejected till such destructionrdquo

Hence we regret to inform you that you will have to take back the stocks available of the abovesaid batch at your own cost from the drug stores where you have supplied the above batch

Kindly acknowledge the receipt of this reference at once

P r o c u r e m e n t A u t h o r i t y Seal and Stamp

Copy to Ref No dated

1 ) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated13082010

To

Sub Frozen Drugs-ordered to return to the Suppliers-reg(New drug policy 2009) Previous letterinvoice ref

The following products which were earlier frozen have now been ordered to return to suppliers directly with permission from the State drug Authority In this regard the suppliers have been instructed to take back their failed batch from the drug store of the stores Hence you are now instructed to return the following failed batches to the suppliers by obtaining proper authorization letter and acknowledgements from them

60

Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

Kindly acknowledge the receipt of this reference at once

Procurement Authority Seal and Stamp

Copy to

Ref No dated 2) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated14092010

To

Sub Frozen Drugs-ordered to return to the Suppliers- for issue of gate pass after verification reg(New drug policy 2009) Previous letterinvoice ref

The following products which were earlier frozen have now been released Hence they may be issued Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

Kindly acknowledge the receipt of this reference at once

Procurement Authority Seal and Stamp

Copy to

61

Ref No dated 3) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated

To

Sub Stop instruction-reg(New drug policy 2009) Previous letterinvoice ref

Until further instructions stop issue all the batches of the following item Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

You must intimate the available stock in the stores of the said batch Number to the Procurement Authority immediately Also retrieve quantity if already issued

Procurement Authority Seal and Stamp

Copy to

Ref No dated 4) HOD Procurement Office of

62

Appendix II Material handling in drug stores

Rack approx rates and dimensions

S No

Item Description UOM Approx Rate

1 MEDIUM DUTY RACK SIZE 2900 H X 3090 W X 800 D IN MM (AS PER SPECIFICATION)

Each 2499800

2 MEDIUM DUTY RACK ADD ON UNIT FOR SIZE OF SR NO2

Each 2243100

To locate a Box no 3 Rack no 14 in row3

SAMPLE OF RACK no Bin numbering -------------- S a y R K 1 4 R o w 3 B o x 1 6

SAMPLE LAYOUT of RACKS in a Drug Stores

63

Sample of another warehouse of distribution warehouse system

64

65

Slotted Angle racks with bin cards

66

Plastic Pallets

Plastic pallets ar e l i g h t w e i g h t l o w- c ost and exceed industry standards for strength and durability

NOTE A pallet has bottom deckboards (see sketch) A skid does not have bottom

67

deckboards

Battery Operated Stacker

Electric Stacker Ehh (Manual Push Type) - Manual drive - Lifting electrically with Battery 12 V 88 Ah - For loading and un-loading of trucks - Battery and loading device built - in - Battery charge gauge and charging current gauge Simple and Easy Operation - Lifting and Lowering electrically direct on steering arm - Pulling and pushing through steering arm - Electrically operated relief valve on hydraulic aggregate Safe Operation - Emergency Off Switch - Constant lowering speed - Protection through lowering brake valve - Overload protection through overload brake valve - Load chains covered preventing pinching threat - Electrically interlocking during loading process - Secured battery compartment opens upwardly - Stable buffering of the steering arm in upright position - In accordance with EWG Guidelines 89 240 - In accordance with VBG 12b Prevention of Accidents

Pallet Truck [ Top ]

68

----------------------------------------------------------------------------------------------------------------------------

For Transport Of All Goods On Pallets Safe and Easy Operation - through single hand operation Lifting moving

lowering with steering handle - neutral position of the hydraulic possible - overload pressure relief valve Long Service Life - robust co n s t r u c t i o n

- special hardened axles - hardened chromium plated ram - maintenance free Easy Maneuverability - through rubber steering rollers - nylon fork rollers

A h a n d t r o l l e y

69

Trolley with plastic bins for several items del ivery

70

Digital Weighing balances

Balances amp Scales EF Seriers Precision Electronic Balance

71

1

Ice lined Refrigerators

600 litres refrigrator

72

Walk in cooler

vacuum cleaner

73

bull System of Tendering at a Glance

8

DIRECTORATE OF HEALTH SERVICES MADH YA PRADESH

No Q E q p O c t 7 7 Bhopal the 2 6 th October 1977

(E x t r a c t e d f r o m t h e G O and reproduced f o r 2 0 1 0 -11 to have clearity on process of

procurement )

To

The Deans

The Divisional Joint Directors of Health

Th e J o int Director of Ayurveda

The Administrative officer ESISIndore

The Superintendents of Medical College Hospitals

The Superintendents of Special Hospitals

The Civil Surgeons

The District Family Welfare cum Health Officers

The Principals RHFWTC

MADHYA PRADESH

Subject -Rules Orders for management of stores

The Government of Madhya Pradesh in the department of Public Health and family Welfare have by their order No 305847795-2877MedIII dated the 13 th

October 1977 issued Rules for the management of STORES These come int o force from the day they are received by the officer-i n- charge of an institution

It is desired that these Rules be followed strictly both in lsquoletter and spiritrsquo and no explanations would be accepted for non-compliance

Sufficient number of printed cop ie s a r e be ing se n t to you f o r d istr ibution a m ongst your subordinate staff concerned with the subject

A C Gaur For Director Medical Services

Madhya Pradesh

9

ACQUISITION OF STORES

The word Stores used hereunder applies generally to all articles expendable as well as dead stock of the nature of plant machinery instruments furniture fixtures medicines linen etc etc

Any authority which is competent to incur contingent expenditure may sanction the purchase of stores required (sub ject to his d e le ga tion of f ina nc ia l pow e r s) pr o vide d the following rules are observed-

(a) A Purchase Committee comprising of atleast three Gazetted Officers is formed for approving quantity and quality of stores required

( b ) An enquiry for the articles purch ased should be sent out to various manufacturers and dealers if the total of the order is for Rs 15000 or less In case the purchase order is likely to exceed Rs 15000 ldquoopen tendersrdquo be called through news paper publicity ( f igur e s p e r ta in to 1 977)

(c) Stores s h o u l d n o t b e p u r c h a s e d i n s m a l l q u a n t i t i e s and often if such store is not perishable

( d ) Requirement of the whole year to be worked out a nd n o stor e sh ould b e p ur c h a se d in e x c e ss o f the requirement

(e) P u r c h a s e s h o u l d b e m a d e i n t h e m o s t e c o n o m i c a l manner but q ua lity ne e d not be sa c r if ic e d in the interest of the economy

(f) The details regarding the quality desired and expected purchase quantity should be mentioned in t h e e n q u i r y

(g) Purchase order should not be split up to avoid the ne c e ssity o f obta ining th e sa nc tio n o f t h e h i g h e r authority

( h ) The date and time of opening of the tender should also be published and in case the tenderers desire to be p r e se nt o n th e o c c a sio n th e y should b e a llo w e d t o d o s o

( i ) Mere initialing on the covers of the tenders is not sufficient All the Purchase committee members s h o u l d s i g n o n e a c h a n d e v e r y p a g e o f t e n d e r q u o t i n g t h e r a t e s A n y r a t e s w h i c h h a v e b e e n overwritten by the tenderer should not be c o n s i d e r e d u n l e s s t h e y b e a r t h e t e n d e r e r rsquo s s i g n a t u r e and subsequently signed by a member o f t h e Purchase committee

( j ) A list of tenders opened should be made out and t a l l i e d w i t h t h e o n e o f t h o s e r e c e i v e d i n t h e o f f i c e Such a list should be signed by all the members of the Purchase committee

( k ) A comparative statement is then made and lowest t e n d er i s a c c e p t e d s u b j e c t t o q u a l i t y o f f e r e d b e i n g

10

satisfactory Samples of non perishable articles should be preserved safely under lock and key for comparison till the contract for supply is in force

( l ) R e a s o n s for rejecting the lowest tender and accepting the h i g h e r o n e s h o u l d a l w a y s b e r e c o r d e d in writing by the Purchase Committee

(m) No reason for rejecting the lowest tender need to be communicated to the tenderer

( n ) Every purchase order should clearly mention that the articles ordered shall be accepted subject to t h e approval of the Purchase Committee

( o ) Rules regarding deposition of earnest money and security money should be observed

( p ) For emergent purchases in public interest when there is no time to observe Store Purchase Rules purchases should be made up to Rs 2 5000 (refers to year -1 9 7 7 ) a t a t i m e A s f a r a s p o s s i b l e t h i s practice should be avoided

II PLACING OF ORDERS (a) For medicines and such other articles which the Medical Stores Depot Bombay

supplies order be placed with them at a specified time ( b ) For articles not on the Bombay Stores Depot Bombay lsquolimitedrsquo or lsquoopenrsquo

tenders be invited as the case may require It would be preferable to place orders on the manufactures or their authorized distributors

(c) For placing the orders on PSUrsquos Laghu Udyog Nigam or Organisations approved by the State government no tender needs to be invited

( d ) Price preference upto 10 is available to Small Scale Industries of this State only(not applicable as per New drug policy 2010 -1 1 )

III RECEIPT OF STORES All materials received should be examined counted measured or weighed as the

case may be when the delivery is taken The stores thus verified be may be immediately entered in the stock register Book under proper headings and this fact should be recorded on the body of the bill mentioning the page number of the Stock Book It should also be mentioned whether the quality and the quantity are correct as per the requirement Soon after the receipt each item be stamped with the initials of the institution

IV CUSTODY

(a)The head of the institution should ensure suitable accommodation for keeping the stores with a view to prevent losses through theft accident fraud or otherwise

(b) Separate Stock Accounts should be kept of-( i ) D e a d S t o c k-such as plantmachineryfurniture equipmentinstruments

etc (ii) Expendible items such as medicineslinenrubber goods etc (iii) Perishable articles

(c ) all recepts and issues in the stores stock registers should be on the authorityand under the signature of a respon sible officer deputed for the purpose

11

V ISSUE OF STORES (a) When materials are issued from stock the officer -i n ndashcharge should ensure that the indent is in proper proforma (Annexure A) and the person taking delivery is an authorized one (b) The issue vouchers (Annexure B) for articles should be prepared in triplicate by one single stroke of pen The first copy will remain with the records of the stores The second and third copies will go to supplies The second copy will be retained by the person receiving the supplies and the third copy will be returned by the receiver to the stores after making entries of hisher stock book page number etc against each item ( C ) E v e r y t i m e i s s u e b e r e c o r d e d i n t h e s t o c k b o o k o f t h e s t o r e s w i t h s i g n a t u r e s o f t h e O f f i ce r i n -charge

(d) Every issue made from the Central Stores to other institution should show cost of article preparation of Annual Stores Account at a later date

VI Maintenance of Stock Books (a) Stock book should be kept under the charge of a responsible person and should be

saved from loss and destruction ( b ) While making new entries in the main Stores Stock book cost of each item

should be entered though this need not be done in the case of registers in Wards Operation Theatre Out door etc

(c) There should b e n o o v e r-writing or interpolation or smudging of figures Any f i g u r e i f i t i s t o b e c o r r e c t e d s h o u l d b e c l e a n l y c u t a c r o s s a n d t h e n e w f i g u r e should be written by its side or below it under proper attestation

( d ) Stock books should always have a page count(each page be numbered) A certificate showing the number of pages be given on the first and the last page under the signatures of a Gazetted Officer

(e) Receipts issues and balances should be worked out for every item and attested regularly by the Offic er-i n -Charge of the Stores

(f) In the receipt column details regarding the size quality and any special features if t h e r e b e s h o u l d b e r e c o r d e d e g i n t h e c a s e o f A l m i r a h i t s s i z e a n d w h e t h e r i t i s of Steel or Wood

(g) In the Stock-book of library Edition and the ye a r o f p ublic a tion of th e book should always be mentioned

( h ) In case of medicines having an expiry date a list of such medicines be made out and should be checked every week Two months prior to the date of expiry if the s t o c k i s s t i l l f o u n d s u f f i c iently high intimation should be given to Directorate of Health

(i) N o r e m o v a l o f d e a d s t o c k s h o u l d b e m a d e f r o m t h e s t o c k ndash B o o k u n l e s s s o a u t h o r i z e d b y t h e c o m p e t e n t A u t h o r i t y

(j) While making a new Stock book and transferring the stocks therein it should ensured that the page number of the old stock book is shown in the new stock b o o k a n d s i m i l a r l y p a g e n u m b e r o f t h e n e w s t o c k b o o k i s m e n t i o n e d i n t h e o l d one This has to be done to facilitate cross checking whenever desired

( k ) T h e r e h a v e t o b e d i f f e r e n t s e t s o f proforma for dead stocks and for expendable items

Annexure ldquoCrdquo is for former and Annexure ldquoDrdquo for the latter varieties

12

VII PROCEDURE OF INDENTING FOR WARD amp OTHER SECTIONS OF THE INSTITUTION

(a) There has to be an Indent Book with every such section wh ich receives and issues medicinesequipment

( b ) The indent shall be prepared by the nurse Compounded -i n -c ha r g e of th e WardSection in te single copy on the Performa (Annexure A)

(c) The indent so prepared will be signed by the medical officer resident ndash i n c h arge or in his absence by a doctor senior to him but associated with the ward section

( d ) The indent shall then be signed by the head of the institution (Superintendent or the Civil Surgeon as the c a se ma y be ) o r b y his A ssista n t if th e la tte r is so authorized in writing

(e) The indent book is then presented to the main Store for effecting issue (f) The Store will then prepare issue vouchers (Annex B) in triplicate as directed

in Paragraph V (b) supra The supplies and the Indent Book are taken back by the Ward Section- i n - charge after signing the first copy of the issue voucher

(g) Te supplies after arriving in the WardSection shall be entered on the WardSection stock register which is prepared on a proforma (Annexure E) and page number of each entry be shown o n t h e 2 n d a n d 3r d copies of the Issue

voucher The 2 n d copy of the voucher is to be retained in a file in the wardsection but the 3r d c o p y s h o u l d b e r e t u r n e d t o t h e s t o r e b e f o r e s u b m i t t i n g a fresh indent The Store has to be maintain separate files of the 3 r d copies Wardsection-wise

VIIIHOW OFTEN TO INDENT

(a) A wardsection ndash i n -charge should work out an average weekly expenditure of each item and efforts be made to replenish the WardSection stocks every week

( b ) T h e M a i n s t o r e i n o r d e r t o a v o i d h e a v y rush of work should fix a day of issue for each major specialty T w o or th r e e minor spe c ia ltie s c a n be gr o upe d f o r one day

IX EMERGENT INDENT It is very likely for unforeseen reasons either the weekly indent of WardSection stock might get exhausted earlier or something which was not there in the lsquoweekly indentrsquo is required Under such circumstances an ldquoEmergent Indentrdquo could be made out in the usual manner but under the signature of the Unit-i n- chargeconsultant and it must be countersigned by the head of the institution (and not by his assistant) These supplies have also to be entered in the wardSection stock books like others

13

X HOW TO INDENT

(a) The ward Section -i n - c h a r g e s h o u l d e n s u r e t h a t t h e s t o c k s u n d e r t h e i r c h a r g e a r e not unnecessarily large and only a realistic quantity is indented once a week

( b ) The indent should not be made out in the names of the patients or by bed numbers The indent should be for the Wardsection as a whole

XI KEEPING OF RECORDS IN WARDS AND SECTIONS

(a) A set p r o f o r m a ( A n n e x u r e E ) s h o u l d b e u s e d i n t h e w a r d s e c t i o n f o r s h o w i n g u p receipts and issues Balance of expenditure for each item to be drawn out every morning by nursecompounder in charge before writing out the Indent or before restarting work The medica l O f f ic e r r e side nt in c ha r g e sh ould a tte st th e e ntr ie s after satisfying himself- by random checking at least once a week

( b ) To support the above mentioned expenditure the Bed head Tickets (treatment charts) are very important Each medicine prescribed should be legibly written indicating the total quantity prescribed if the medicine is to be deleted from treatment the fact should be mentioned as to how much of the drug was issued to the patient before switching on to another drug The suggestion is that a separate treatment card be maintained for each indoor patient ( Annexure ndash G) A summary s h o w i n g t h e t o t a l a m o u n t o f t h e p r o p r i e t a r y d r u g s c o n s u m e d b y t h e p a t i e n t d u r i n g is hospital stay be worked out and noted in the summary card

XII ACCOUNT ABILITY OF DRUGS BROUGHT BY THE PATIENT OR RECEIVED IN DONATION BY THE WARDSECTION _IN -C H A R G E

The drugs receoived from the non - governmental sources should be entered on the receipts side of the WardSection Sto c k b ook a n d issu e s to show n a s in th e o the r cases on the issues side

XII RSPONSIBILITY OF STORES AT VARIOUS LEVELS (a) The head of the institution shall be held responsible for non-observance of

rulesprocedures laid down by the Government ( b ) The Medical officerresident in charge of the stores and the store keeper shall be

held responsible for any irregularity found in the stores or for ignoring the ordered pattern of working It shall be the duty of the Medical officer Incharge of the Stores to occasionally check the WardSection Stock-b o o k s t o t a l l y t h e e n t r i e s made in the 3 r d copy of the Issue vouchers [as laid down under V (b)supra ]

(c) The Medical officerresident in charge of the WardSection shall be responsible for irregularities in indenting stocksfor maintaining stocks much in excess of the req uirement and for improper keeping of BED HEAD TICKETS (treatment chartsCards)

( d ) The NurseCompounder ndash i n -charge of the WardSection shall be responsible for shortages in stocks for putting up inflated indents and or for not taking into account medicines b rought by the patientson the WardSection stock-books Heshe shall also be held responsible for ensuring proper distribution of medicines to each and every patient under his her charge

XIV DISTRIBUTION OF MEDICINES FROM OUTDOOR DEPARTMENT (A) ( a ) T h e r e are proprietary and non -proprietary medicines (like mixtures ointments

and lotions) which are to be distributed gratis to patients 14

(b) The Outdoor incharge shall arrange to maintain a stock of common drugs (list of which shall be prepared by the Head of t he Institution) and arrange to replenish the stocks once a week as has been laid down for wards (c) No proprietary drugs shall be issued on the prescription of an intern ( d ) The Head of the institution shall make out a list of drugs which can be issued on

the prescription of a houseman from the Outdoor stock without the countersignature of any other authority

(e) The residents can prescribe any drug from Outdoor stock without the counter signature of any authority

(f) The Consultants can prescribe any drug to any ot h e r o u t e r p a t i e n t e v e n i f i t i s n o t s t o c k e d i n t h e o u t d o o r b u t t h i s s h a l l h a v e t o b e c o u n t e r s i g n e d b y t h e h e a d o f t h e institution for issue from The Main Store

(B) T h e p e r s o n i n c h a r g e o f t h e O u t d o o r m e d i c i n e s s t o c k s h a l l k e e p a r e c o r d o f t h e q u a n t i t y o f t he medicines issued to each patient and instead of writing the name and other details e may only put down the Registration number of the patient and the quantity issued

At the end of the day he must work out the total expenditure of eac item and draw it s balance

The Medical officer in charge of the Stores and the Head of the institution sould check these records at least once a week and affix is signature to confirm their inspection

(C ) No proprietary medicine shall be issued without a valid issue s l i p ( A n n e x u r e- F)

(a) For Housemen the slip would be of brown colour ( b ) For residentsDemonstrators it shall be of pink color (c) For consultants the issue slip should be white ( d ) All issue slips should be printed and pages serially numbered (e) T h e d o c t o r s t o w h o m s u c h i s s u e s l i p s w o u l d b e i s s u e d s h a l l b e h e l d

responsible for their sa f e ke e ping a n d th e y w ould e n su r e tha t th e se slip s would be printed and serially numbered

(f) The doctors prescription slips (for issue from hospitals) of proprietary drugs be prepared in du plicate with the help of carbon One copy should be given to patient for obtaining medicines from the Stores and the other would remain in the Doctors Prescription Slip book

(g) Every issue Slip should be signed and below the signatures a rubber s t a m p s h o w i ng name and designation be affixed The Store people would n o t h o n o u r s l i p u n l e s s t h e n a m e o f p r e s c r i b e r i s c l e a r a n d h i s a t t e s t e d signatures are available to stores

( h ) The Store Staff would file prescription slips of each doctor separately to facilitate the scrutiny at least once a month by the Head of the Institution Such a Scrutiny would reveal over prescribing of or injudicious use of drugs

(C) Proprietary medicines should not be issued for more than three days requirement at a time The only exceptions being cases for cancer pulmonary tuberculosis and leprosy In exceptional cases an officer not below the rank of a Consultant can prescribe for more than 3 days but after the countersignatures of the Head of the Institution

15

XV LOSS BREAKAGE DAMAGE ETC

(A) Any loss of public money departmental revenue of receipts stamps stores or other property held by or on behalf of the Government caused by defalcation or otherwise discovered in an office or institution should immediately be reported by the officer concerned to the head of department through his immediate superior as well as to the Accountant General if the loss exceeds Rs 20000(fig of 1977) (for Proforma see Annexure I)even when such loss has been made good by the party responsible for it Such reports must be submitted as soon as possible and soon after suspicion arises that there has been a loss they must not be delayed while detailed enquiries are made

When the matter has been fully investigated further and complete report should be submitted of the nature and extent of loss showing the errors or neglect rules by which such loss showing the errors or neglect of rules by which such loss was rendered possible and prospects of effecting such recovery

The s ubmission of such a repot does n o t d e b a r t h e l o c a l a u t h o r i t i e s t a k i n g f u r t h e r a c t i o n which may be deemed necessary like handing over the case to the police

Every Government servant should realize fully and clearly that he will be held personally responsible for any loss sustained by the government through fraud and negligence on is part and that will also be held personally responsible for any loss arising from fraud or negligence on the part of any other Government servant to extent to which it may be shown that he has contributed to loss by his own action or negligence

A s s o o n a s s h o r t a g e i n s t o c k o r l o s s i s d i s c o v e r e d a p a r t f r o m r e p o r t i n g t h e m a t t e r a responsible officer should be deputed to investigate the matter

W h e r e t h e r e i s n o l i k e l i h o o d o f a d e l i b e r a t e t h e f t b u t l o s s i s a result of neglect onlythe loss should be made good by the person on whose charge or custody the article lost remained

(B) As soon as damage or breakage of Government property is detected certain steps mentined under should be undertaken-

(a) A p r o m p t t h o ro u g h i n v e s t i g a t i o n i n t o t h e c a u s a t i o n o f b r e a k a g e o r d a m a g e s h o u l d be undertaken by the doctor-i n -charge of the WardSection or by the Head of the Institution

( b ) The investigating officer should draw conclusions as to whether the breakagedamage has been a result of-

(i) C a r e l e s s a n d n e g l i g e n t h a n d l i n g ( i i ) Unpredictable action of the patient for whom the equipment was

being used (iii) Accidental ( i v ) Manufacturing Defect

A report is then prepared in duplicate by person in charge of the article under question on the lsquobreakage and loss proformarsquo (See Annexure H)

16

These reports have to be signed by the investigating officer and are to be then submitted to competent authority for suitable action One copy which is returned is to be kept with the Stock Register In cases where the b r e a k a g e o r d a m a g e i s o f s u c h b i g g e r d e g r e e t h a t s atis factory repairs are not possible a n d if suc h b r e a k a ge o r da m a ge is o f su c h a de gr e e that satisfactory repairs are not possible and if such breakage or damage has been caused-

( i ) B y a G o v t s e r v a n t because of negligent or careless handling cost of the article should be recovered from him and credited to the treasury (ii)On account of reasons mentioned above that is un predictable action of the patient accidental or manufacturing defectthe article could be written offsubject to powers delegated to the concerned for such purpose

(C )Shortages detected during biannual physical verification of the Storeshave to be dealt in a similar manner

(D) it shall be at discretion of the competent authori ty (who is empowered to write off the loss) to reduce the amount of recovery upto 50 of the cost of article provided that before arriving at such a decisionhe has taken into account the following points (a) Normal life span of the article under questi on (b) Period for which it has been in use (c ) Condition of the article at the time of loss or damage and (d) Whether it was on account of careless or negligent act or not

XVI PROCEDURE FOR WRITING OFF STORES

(a) When any Stores become unserviceable otherwise than in ordinary course or by fair wear and tear their value should be treated as loss to the Government and in such cases cost should be recovered from the person responsible for his negligence

( b ) A s t r i c t w a t c h s h o u l d b e k e p t o n t h e m e d i c i n e s w h i ch bear an expiry date and if there is no likelihood of their being utilized locally intimation of the fact should be sent to Directorate of Health services and also to all o t h e r d i s t r i c t s s i m u l t a n e o u s l y s o t h a t t h e y c a n b e p u t t o u s e b e f o r e t h e expiry date In the event such a course is not followed and the Government i s p u t t o l o s s c o s t o f t h e m e d i c i n e i n q u e s t i o n s h a l l b e r e c o v e r e d f r o m t e defaulter

(c) For declaring articles as unserviceable a Committee of three members should be formed in each officeinstitution This Committee should examine each and every article brought before it and should record full reasons for condemning them and also say how the articles condemned have to be disposed of-whether by sale (by public auction) or otherwise

I f t he local Authority is not competent to write off the articles condemned by the Committee it should send the proposal to the higher authority for suitable a c t i o n

17

In Institutions where there is only one doctor a list of articles to be condemned should be p r e p a r e d a n d o r d e r s o n i t b e o b t a i n e d f r o m t h e inspecting authority during inspection

While preparing any list of articles for condemnation details regarding the date of purchase date of receipt period during which it remained in use usual life of the article and its purchase price should be noted against each item

( d ) The condemned articles should not be struck off the Stock Register till the competent authority sanctions its write ndashoff Details of Authority under which the article has been written off should be mentioned in stock register

XVII DISPOSAL OF WRITTEN OFF ARTICLES

Articles like linen should be torn into strips 10cm width so that they could be burnt or given to Government Jails for making carpets

Items like bed -pans bowlsurine po ts etc should be crushed and kept for auction

Brass utensils have also to be crushed to destroy their shape and could be either auctioned or after inviting rates from several dealers could be locally sold to highest bidder

In case when condemned ar ticles have to be sold by public auction they should be stored safely and the Government Auctioneer be intimated In case he expresses his inability to undertake the auction the officer should proceed with the auction departmentally The sale proceeds in either case should be credited to the Treasury as miscellaneous receipts under the Proper head of account

XVIII PHYSICAL VERIFICATION (a) The stocks held by officesinstitutions in various sections should be physically

verified twice a yearin the months o f April and October ( b ) Checking should be done by an officer other than te one who holds the charge of

Stores (c) Verification should be done in presence of officer holding the charge of Stores ( d ) All discrepancies found during the verification should be properly investigated

and accounted for

(j) Any excess detected during verification should be entered in the Stock book as Receipts with the remark ldquo Excess found on verificationrdquo

(ii)any shortage should be noted in issues column of lsquo Issuesrsquo described as lsquoshortage fou n d o n v e r i f i c a t i o n rsquo

XIX ANNUAL STORES ACCOUNT This account should be prepared according to the instruction issued from the department from time to time This should account for the outgoing financial year on the following lines -(a) Cost of the articles under various heads on the last day of the previous

year 18

( b ) Cost of the articles under the various Heads Received during the year (c) Cost of various articles written off during the year under review ( d ) Cost of the articles on the last day of the year or on the firs t d a y o f t h e

financial year following

19

Annexure A WardSection Indent Register No Issued on

Name of institution Page Folio No

Serial no Name of Article Quantity in Stock

Quantity required

Prepared by Approved by Recd by Note-Indenting Officer to sign and affix seal with name and

designation below the last item to avoid additions in one strokeno issues to be made by storesif Issue vouchers of

previous Indent has not been returned back by the WardSection

20

Annexure B Issue Voucher No (printed number)

Supplied to Wardsection Date

Indent no

Serial no Name of Article Quantity in Stock

Quantity required SB No

Stores-in MO Resident in Sign of charge charge WardSection

NurseCompounder Prepared by Recd Approved by by

Note-Indenting Officer to sign and affix seal with name and designation below the last item to avoid additions in one strokeno issues to be made by storesif Issue vouchers of previous Indent has not been

returned back 1st copy-Stores 2nd copy -Wardsection3rd copy-Tobe reurned to sores with Stock book entries

21

Annexure C

STOCK REGISTER FOR DEAD STOCKS

SERIAL NO DATE OF RECEIPT

Article with description

No of pieces Cost Details of

Bill Signature No Disposed

Date of disposal

Manner of Disposal

with Authority

Value realised Signature

1 2 3 4 5 6 7 8 9 10 11 12

P r e p a r e d B y C h e c k e d b y A p p r o v e d b y

Date Designation Name of Institution

22

Annexure D

STOCK REGISTER FOR EXPENDABLE ITEMS Name of article

Date

From where

received with cost

Quantity Signature To whom issued Quantity Balance Signature

1 2 3 4 5 6 7 8

23

Annexure E

Receipt amp Issue Register for WARDSSECTIONS (one or more pages as per requiremnt for each medicine)

NAME OF MEDICINE RECEIPT ISSUE

DATE Quantity In Stock

Date of

Issue

Issued toMention Bed no amp

quantity (in bracket) (For

Outdoor cases give Regd No)

Balance Signature

24

Annexure -F

OUTDOOR FREE MEDICINE SLIP In Duplicate

Name of Patient Registered No Date

Sr no Name of Medicine Quantity

Seal amp sign of doctor

25

Annexure-G

TREATMENT CARD

WARD NO

NAME OF PATIENT BED NO DATE amp TIME OF ADMISSION DATE amp TIME OF DISCHARGE

DATE MEDICINES PRESCRIBED SIGNATURE

26

ANNEXURE -H

PROFORMA FOR BREAKAGE amp LOSS

NAME OF OFFICEINSTITUTION DATE PLACE

SRNO NAME amp

DESCRIPTION OF ARTICLE

COST DATE OF PURCHASE

REASON CAUSE OF BREAKAGE

RECOMMENDATION OF INVESTIGATING AUTHORITY

Signature

Orders of the Competent Authority

Signature

27

Annexure ndash I Loss- Procedure for Reporting

1 The exact nature of the defalcation 2 The full extent of loss 3 The actual period covered by the defalcation 4 The defects in the negle c t o f r u le s by w hic h the loss was rendered possible

and circumstances which facilitated the defalcation 5 The names of the officials held personally or technically directly or

indirectly and wholly or partially responsible for the irregularity c o m m i t t e d i n t h e c a s e

6 Whether the c a s e a s b e e n J u d i c i a l l y t r i e d i n a c o u r t o r n o t i f s o c o p i e s ( i n duplicate) of the Judgment may please be furnished Copy of police report may also be furnished

7 The remedial measures adopted as safeguards against the losses hereafter 8 The prospects of re covery of the loss and he action taken to effect

recovery together with the amount recovered 9 Head of Account to which the Loss is debitable may be informed

Signature of Head of Office with seal

NoteA copy of this report is to be sent to AGMPThis is as per M P Finance Code Vol I

28

STORAGE AND STOCK MANAGEMENT

29

Foreword

The New Drug Policy 2009 is being implemented in the State of Madhya Pradesh

In order to have a proper procedure for Storage maintenance and expiry management of the drugs it is necessary to follow Good Storage Practices with Standard Modules for pharmacistStore keepers

Proper guidelines on Storage Practices can lead to better Stores and inventory upkeep with medicines being properly stored in racks with proper cleanliness and hygiene

This is a step towards storage maintenance and expiry management at the various stores in the state Looking forward to see that the heads of all health facilities take benefit from this module

D ir e c t o r M e d i c a l S e r v i c e s

30

INDEX

Sr No P a r t i c u l a r s P a g e

1 S T O R A G E A N D S T O C K M A N A G E M E N T 4

1 Quarantine and checking of stocks 11 Quarantine area 12 Checks to be carried out on new stocks

2 S t o r a g e 21 Need for proper storage 22 Different patterns of storage 23 Different means of storage 24 Temperatureclimatic conditions 25 Special storage of supplies 26 Storage and stability of medicines

3 Stock Control and Expiry Monitoring 31 Stock control 32 Stock rotation and expi r y m o n i t o r i n g

4 Other aspects of storage 41 Design of a storage area 42 Cleaning and maintenance 43 Product recalls 44 Returned goods

2 A p p e n d i x 1 Templates of letters for use if found not of Standard Quality [Frozen and expired goods ]

Frozen Drugs-ordered to return to the Suppliers-reg(New drug policy 2009)

Frozen Drugs-ordered to return to the Suppliers- for issue of gate pass after verification reg(New drug policy 2009) Stop instruction-reg(New drug policy

2009) Appendix II Material handling in drug stores

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3 PROCUREMENT ndash Government Order Relating to

the Management of Stores

(Reproduced for reference material on basic

procedure in decentralized system followed by

Health facilities in 1977)

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F L O W C H A R T S f o r a BI R D S E Y E V I E W o f

P R O C U R E M E N T

5 5

ACQUISITION OF STORES 6 1

PLACING OF ORDERS 6 2

RECEIPT OF STORES 6 2

CUSTODY 6 3

ISSUE OF STORES Maintenance of Stock Books

6 3

PROCEDURE OF INDENTING FOR WARD amp OTHER SECTIONS OF THE INSTITUTION

6 4

HOW OFTEN TO INDENT 6 5

EMERGENT INDENT 6 5

HOW TO INDENT 6 5

KEEPING OF RECORDS IN WARDS A N D S E C T I O N S

6 6

ACCOUNTABILITY OF DRUGS BROUGHT BY THE PATIENT OR RECEIVED IN DON A T I O N BY T H E WARDSECTION _IN - CHARGE

6 7

RESPONSIBILITY OF STORES AT VARIOUS LEVELS

6 7

DISTRIBUTION OF MEDICINES FROM OUTDOOR DEPARTMENT

6 7

LOSS BREAKAGE DAMAGE ETC 6 8

PROCEDURE FOR WRITING OFF STORES 6 9

DISPOSAL OF WRITTEN OFF ARTICLES 7 1

FORMATS TO BE USED 7 3 - 81

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STORAGE AND STOCK MANAGEMENT The expiry periods of pharmaceutical products have meaning only if the products are stored under proper conditions otherwise products are likely to lose their potency before the actual date of expiry

A pharmacist is a vital link in the distribution chain for pharmaceutical products The medicinal products remain for a long period during the distribution cycle at the wholesaler and at retail pharmacies It is therefore very important to maintain proper storage conditions in these units

Every community pharmacy however large or s mall needs to store and manage its medicine stocks effectively There must be systems to ensure

middot bullbull Secure storage middot bullbull Clean and correct environmental conditions during storage middot bullbull Accurate and effective record keeping middot bullbull Effective stock rotation and expiry monitoring middot bullbull Effective fire and theft prevention middot bullbull Effective rodent pest control

For easier un derstanding this module has been divided into the following sections

1 Quarantine and checking of stocks 11 Quarantine area 12 Checks to be carried out on new stocks

2 S t o r a g e 21 Need for proper storage 22 Different patterns of storage 23 Different means of storage 24 Temperatureclimatic conditions 25 Special storage of supplies 26 Storage and stability of medicines

3 Stock Control and Expiry Monitoring 31 Stock control 3 2 S t o c k r o t a t i o n a n d e x p i r y m o n i t o r i n g

4 Other aspects of s t o r a g e 41 Design of a storage area 42 Cleaning and maintenance 43 Product recalls 44 Returned goods

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1 QUARANTINE AND CHECKING OF STOCKS

11 Quarantine Area D r u g S t o r e pharmacies receive stoc k s f r o m su pplie r s a c c or d ing to pur c h a se o r d e r s T he stock that is received must be visually checked for quality and quantity The stocks must be kept in a separate area until the checking is done to avoid intermixing with existing stock This necessitates the presence of a separate area within the pharmacy w h e r e i n t h e storage and other checking of stocks can be performed This area is called the QUARANTINE AREA This area should be marked and identified adequately to distinguish it from other areas

The area may be marked using different means 1 ) A s m a l l board saying Quarantine on a separate table used exclusively if it is in the middle 2) A board on the wall if the table on which the quarantine stock is placed is against the wall

middot Stock received from wholesalers should be immediately transferred t o t h e Quarantine Area

middot In the Quarantine area the stock may be stored on racks shelves or in cupboards to prevent ingress of moisture dirt and other contaminants

middot Regular stocks from the pharmacy should not be left kept in the quarantine area Special care has to be taken in case of refrigerated medicines supplied by the suppliers so tha t the y do not remain in the quarantine area for long periods of time They should be immediately checked on receipt and transferred to areas for refrigerated storage s o a s to maintain the cold chain bull

Advantages of having a separate Quarantine Area middot Avoids cross mixing of newly arrived stock from existing stock till it is checked middot Lays stress on checking the quality of the stock received middot S to ck checking ensures t hat defective andor expired goods do not enter the storage areas

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bullbull

bullbull

12 Checks to be carried out on new stock

Unpacking and checking stock

Supplies received should be unpacked and checked in the quarantine area Staff doing the checks should be adequatel y trained in what they have to check when stock arrives

Checking should be seen not simply as counting the units received but as a part of the quality assurance system bullThis should include middot Visually inspecting the packaging middot Checking the integrity of containers middot V erifying the completeness and leg ibility of la b e ls ( a ppr o ve d dr u g name strength any special storage instructions and expiry date)

bull

The expiry dat e should be checked to ensure that there is adequate shelf life remaining

Supplies should be individually checked using a checklist 35

Checklists

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The wholesaler supplying the product should be notified immediately in case of any discrepancies ( and the details should be recorded in a register) and sent in a written format to the supplier It should include middot Missing boxes or cartons middot O p en tampered boxes or cartons middot Missing supplies middot Differences in the actual quantity and the quantity shown on the packing middot Additional medicines that had not been ordered but have been supplied middot D a m a g e d b r o k e n o r p oor quality medicines middot Any other discrepancies

The purchase invoices are an important aspect to be considered The invoiced documents should be signed and filed for reference as per the Drugs and Cosmetics Act and retained for at least 3years

If the wholesaler supplies medicines as an emergency without a bill or against a delivery challan

middot The supplies should be checked for integrity and inspected for damage middot The details of supplies received should be recorded middot The supplier should be asked t o send the bill as early as possible middot When the bill is received it should be checked against the details recorded and anomalies if any should be reported to the supplier

To keep a track of the received stock maintaining a S t o c k R e c o r d C a r d c a n b e very useful The entries in the stock record card can be made while checking the stock received STOCK BIN in the stores should have Stock record card

Maintaining a stock card for every product may not be very practical for a retail pharmacy however it could be maintained for costly medicines Nowadays it is much more practical and easier to maintain records using computers

The pharmacist should ensure that medicines manufacturedmarketed by a company are received only through an authorized distribution network of that company This is important to prevent spurious and counterfeit drugs from entering the pharmacy

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2 STORAGE 21 The need for proper storage The storage of medicines and other products is an important requirement of Good Pharmacy Pr actice Appropriate storage of medicines is essential -

middot bullTo ensure that the potency is maintained middot bullTo prevent deteriorationspoilagedegradation middot bullTo ensuremaintain physical integrity

To ascertain that the quality and safety is maintained throughout their shelf life Storage requirements need to be considered on 2 aspects

a) Integrity of medicines Medicines should be stored in such a way so as to maintain their integrity and potency middot Maintain the right temperature required middot Protect from excessive humidity middot Keep medicines away from direct sunlight middot Protect from pests and rodents

b) Physical location middot Should be easy to locate middot Accessible middot Orderlysystematically placed

2 2 D i f f e r e n t p a t t e r n s o f s t o r a g e The pharmacist could follow any of the different patterns of storage The pattern of stora ge should be selected in such a way that it facilitates speedy and efficient dispensing of medicines

The pattern of storage could vary with each pharmacy experience usual practiceroutine of staff and the person-in charge and also depending on space av ailable turnover etc (i) The medicines could be stored c o m p a n y w i s e ie the medicines manufactured by one company should be grouped together and kept in one place Within each company shelfshelves the medicines may be placed in alphabetical order for easy and quick placement and removal Also bottles tubes boxes etc may be segregated within that shelf

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(ii) The medicines may also be stored in a lphabe t ic al o r de r ie they are placed in order from left to right based on their name The first letter of the name is used to g r o u p t h e m e d i c i n e s t o g e t h e r a n d k e e p t h e m i n o n e l o c a t i o n I n s o m e p h a r m a c i e s a l l t h e strip packing are placed in drawers or boxes in alphabetical order each box or drawer containing strips of one particular alphabet This system ensures that the strips always remain e n c l o s e d i n t h e b o x e s d r a w e r s a n d a r e n o t e x p o s e d t o d u s t T h e d i s a d v a n t a g e i s that it might lead to mix -u p o f strips in the same drawer and it may cause a problem incase of similar looking strips in which case a wrong medicine may be dispensed Secondly cut strips lying around in the drawer may lose their identity if the batch n u m b e r andor expiry date is not seen on the cut portion of the strip

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(iii) The medicines may be stored according to their therapeutic class ( e g a n t i b i o t i c s anti asthmatics or anti hypertensives) ie the medicines are kept together based on their pharmacological or therapeutic action

(iv) The medicines may be stockedsegregated according to dosage forms eg l i q u i d s (bottles) solid oral dosage forms eye drops rotacaps ointments etc all stored on separate shelves

Always Remember I Storage of prescription medicines should preferably be separate from OTC medicines OTC medicines especially those that a r e a d v e r t i s e d m a y b e d i s p l a y e d f o r c l i e n t s t o select or to ask questions about [OTC-O v e r t h e c o u n t e r ] II Storage according to temperatures is a must no matter which pattern of storage is followed Also within a particular storage area segregated storage may be maintained In a refrigerator for example medicines may be stored in trays racks and the freezer according to the temperature required

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Whatever pattern of storage is selected all the personnel should ensure that middot The stocks are stored in an orderly manner middot The medicines are kept back in the same place from where they were removed middot All medicines are arranged neatly once in a while

middot The personnel should be careful while storing the medicines middot They should not throw the medicines haphazardly 23 Different means of storage

middot Within each temperature and security zone medicines must be stored so that they are easily accessible and protected against damage

middot Basic means of storage include shelves racks and drawers middot To prevent dust from entering the shelvesracks it is ideal to have glass

shutterssliding glass doors This can however be disadvantageous because accessibilityspeed is hampered in removing a product from the shelf because the glassshuttersliding glass has to be

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opened m o v e d e v e r y t i m e a p r o d u c t h a s t o b e p i c k e d u p U s e o f a i r c o n d i t i o n e r s f o r t h e p h arm acy with a closed door at the e n t r a n c e o r a n a i r c u r t a i n c a n r e d u c e t h e d u s t problem In such cases the shelvesracks may be left o p e n

bull

middot Direct storage of cartons on the floor should be avoided because besides being an unhealthy practice the contents may also be damaged by moisture bull

middot Store medicines preferably in shelves with glass shutters for visibility middot Closed shelves further prevent dust from going in especially in India where most

pharmacies are located along busy roads middot Some medicines have to be refrigerated or stored in a cool or cold place Having a

refrigerator or two (as per the need of the pharmacy) is essential to store suc h medicines at temperatures mentioned on the label bull

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Refrigeration middot All cold chain equipment should meet required standards middot Improvement in refrigeration technology has provided frost -free refrigerators

Pharmacists should opt for frost-free refrigerators as they are easy to maintain and protect printed packaging materials Conventional refrigerators may cause water falling from trays below the freezer on medicines stored in the refrigerator thus causing soggy labels

middot bull Frost-free refrigerators also provide separate and large compartments for the freezer portion (required for storing medicines needing sub-z e r o t e m p e r a t u r e ) and the main storage area with separate doors so that opening one door does not disturb the storage temperature in the other compartment

Care should be taken to keep the refrigerator on 24 hours a day It should not be switched off after working hours It is advisable to have an inverter connected to the refrigerator so that the refrigerator re mains working even when there is a power outage

middot The refrigerator door should be closed tightly middot The refrigerator door should not be left open for too long middot Space should be left between medicines stored in a refrigerator to allow air to

circulate middot The ref rigerator should be placed about an arms length away from the wall

This will increase air circulation thus not affecting the cooling within the refrigerator

middot Vaccines should not be stored on refrigerator door shelves as they are exposed to warmer temperatures each time the door is opened Vaccines should always be stored on the middle shelves of the refrigerator

middot Refrigerated medicines should not be left out of the refrigerator for more than a few minutes

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middot Consumable products like juices energy drinks e t c s h o u l d n o t b e s t o r e d a l o n g with medicines in refrigerators If required they may be kept in a separate refrigerator

middot An adequate number of refrigerators should be planned to store the entire stocks requiring refrigerated storage

middot Adequate procedures should be followed for defrosting cleaning and maintenance of refrigerators

middot Icefreeze packs should be kept in the freezer compartment so that they can be used for transporting cold temperature medicines The packs can be given to clients along with the medicines requiring cold temperature storage so that the temperature is maintained till the client reaches home and can then put the medicines in a refrigerator) Freezer packs can also be used to keep medicines temporarily in case there is a power outage or refrigerator breakdown

Activity

Prepare a SOP (Standard operating procedure chart) for cleaning a refrigerator Discuss it with your staff finalize its maintenance once a month through AMC -A n n u a l Maintenance contract CMC - Comprehensive maintenance contract and put it up on the pharmacy refrigerator Put the Purchase Order details name of manufacturer Phone of Service Engineer and a register to login the Machine service and down timeService reports may be maintained properly

Refrigerator monitoring and maintenance

middot bullIt is important to carry out routine monitoring and maintenance of the refrigerators and to organize an effective repair system

middot bullThe temperature in the refrigerator must be monitored and recorded routinely at least once a day

middot Any breakdown must be reco rded including the period during which the medicines were exposed to uncontrolled temperatures Medicines may then be kept or discarded depending on the problem guidelines or the manufacturers advice

middot Cold chain monitor cards and devices in or on packages that change color or otherwise alert staff to potential damage assist in monitoring (These are likely to be introduced in India soon)

middot It is essential to have a contingency plan in place before a refrigerator breaks down An arrangement can be made to move the contents to a private refrigerator elsewhere in the community or to obtain a regular supply of ice packs until the defect is rectified

Put filled water bottles in the bottom half of the refrigerator door in order to provide cooling in the refri g e r a t o r w h e n t h e r e i s a p o w e r o u t a g e T h i s m i g h t t a k e c a r e o f t h e temperature when there is no current for a couple of hours If the power outage is expected to last for several hours special arrangements such as an inverter UPS have to be made to keep the refrigerator constantly running in the absence of electricity middot Defrost the refrigerator in case of excessive ice formation and preferably at regular

intervals Keep a record of the same

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2 4 T e m p e r a t u r e c l i m a t i c c o n d i t i o n s

i) Temperature control middot The medicines in a pharmacy need to be stored at appropriate temperatures to

maintain their stability middot An air-conditioned environment where temperature can be controlled is

recommended for pharmacies Air conditioning offers the option of setting the t e m p e rature as per requirements

middot bullIt is ideal to have an air conditioner to maintain the temperature below 25 C as most medicines require storage below this temperature Secondly this temperature is pleasing to both the staff and the visiting customers too

middot In the absence of an air conditioner circulating fans may be used middot This need is felt even more in certain parts of India where temperatures soar above 45

C and some areas where it falls to sub zero temperatures In such cases temperature maintenance is essential to prevent deterioration of medicines due to unnecessary exposure to drastic temperature fluctuations

middot This need is felt even more in certain parts of India where temperatures soar above 45 C and some areas where it falls to sub zero temperat u r e s I n s u c h c a s e s temperature maintenance is essential to prevent deterioration of medicines due to unnecessary exposure to drastic temperature fluctuations

i i ) Humidity or moisture control Moisture or humidity can adversely affect the stability of me dicines such as tablets capsules powders

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Gelatin capsules become soft and swell on absorption of moisture The drug content of tablets may undergo surface hydrolysis The presence of moisture may encourage the growth of microbes It is therefore essential to control humidity

To reduce the effect of humidity the following suggestions may be followed -middot Open the windows to allow air circulation Use a fan to circulate fresh (outside) air middot In humid climate a dehumidifier is useful for preventing mo i s t u r e d a m a g e ( i n t h e absence of an air conditioner) middot For bulk containers of tabletscapsules do not keep the container open for a long time and replace the lid or closure immediately after taking out the required number of medicines for dispensing middot Do not allow the medicines to touch the floor or the walls The walls may be damp and may cause moisture absorption damaging the product

middot Calibrated thermometers and manometers can be used to detect temperature and humidity in the pharmacy

middot Periodici t y of checking the temperature should be fixed middot The climatic conditions should be recorded and documented middot Temperature charts should be available for ready reference

Documentation is one of the core activities for achieving and maintaining quality It is one of the most essential components of validation Temperatures in various areas

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including refrigerators should be recorded at a predetermined periodicity usually daily at the hottest time of the day and such documents should be preserved i i i ) Storage conditions A number of storage conditions are mentioned on the labels of medicinal products These conditions have to be properly interpreted and appropriately complied with

According to the Drugs and Cosmetics Rules 1945

1 The term cool place means a place having a temperature between 10 C and 25 C

2 The term cold place means a place having a temperature not exceeding 8 C In case of storage conditions for specific products please refer to Schedule P The Drugs and Cosmetic Rules 1 9 4 5

The Indian Pharmacopoeia specifies the following storage conditions -

Wherever the condition for storage is not specified medicines may be stored under normal temperature In a country like India however where normal temperatures soar to h i gh temperatures it is recommended that medicines be stored in a cool place

Activity Prepare a list of the storage requirements mentioned on the label of about 20 products in your pharmacy and check if the temperature is maintained

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25 Special Storage o f s u p p l i e s If the product has no special instructions normal storage conditions apply This means storage in dry clean w e l l -ventilated premises at temperatures of +15 C to +25 C or depending on the climate up to +30 C (WHO1990) Storage instructions are product specific Different brands of the same generic drug may have different storage requirements as they may have different packaging or formulations It is essential to follow the product manufacturers storage instructions to the maximum extent possible Less stable medicines must be stored in specific conditions to maintain their quality or potency

The following products require special storage facilities

middot Products that must be kept frozen (usually vaccines and sera) middot Products sensitive to h eat an d r e q uir in g r e f r ig e r a tio n ( +2 C to +8 C) middot Products that have reduced shelf life at uncontrolled room temperature and need

mechanical ventilation or air conditioning middot Flammable products that require separate fireproof premises middot Products prone to theft o r m i s u s e

Products needing storage in a controlled environment -

The usable shelf life of the following products may be reduced if stored at uncontrolled humidity or at room temperature in hot climates -

middot Some injectables (eg adrenaline) Most injectable preparations are less stable than solid oral forms (tablets and capsules) Injectable preparations in solution are particularly unstable Many injections must be protected from light as well as heat

middot Intravenous fluids (particularly if packed in p lastic containers) middot Some suppositories pessaries creams and ointments These products may melt at

temperatures greater than 30 C Once this happens it is not advisable to use them because the active ingredient in the formula may get unevenly distributed

middot Products containing rubber latex cellulose or some plastics Condoms most sterile disposable medical devices and surgical products such as syringes needles and catheters require protection from excessive humidity and strong light and heat Any o f these conditions may make products brittle stained amp unusable Sterility cannot be assumed if packaging is damaged

In hot climates these products should be stored in the coolest place possible preferably with air conditioning or air circulation fans

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Products needing freezing or refrigeration-middot Vaccines blood products and many other medicines lose potency if kept even for a

brief period at temperatures outside the recommended range For these products the cold chain must be maintained at every stage of the distribution system

middot Freezing is as damaging as high temperatures for some products including injectable contraceptives ergometrine insulin adrenaline and the DPT DT TT and Hepatitis B vaccines Such products therefore sho uld not be allowed to freeze (not be kept in the freezer compartment)

middot Short periods at room temperature (during transportation or local distribution for instance) may be acceptable for many products (such as ergometrine a n d i n s u l i n ) e v e n t h o u g h s u c h e x posure can to some extent reduce shelf life Other items such as vaccines should always be transported in cold boxes

Storage of insulin injections-

middot Insulin should always be stored in a refrigerator at the recommended temperature of 2 -8 C

middot Insulin should not be kept in the freezer compartment of the refrigerator middot Insulin should ideally be stored horizontally middot It should not be exposed to sunlight or excessive heat middot Insulin suspensions should not be used if the suspension cannot be properly

resuspended due to cake or clump formationbull

Controlled drugs -Narcotics (for example Pethidine injection morphine preparations) and other specified drugs that may be abused are governed by special legislation and regulations The following security measures are suggested in the pharmacy -middot A safe or reinforced double locked cabinet fitted with a light (preferably with a red

bulb) that comes on when the door is opened

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middot A special register recording details of each receipt or issue with 2 signatures physi cal counting of medicines after each entry and signatures at handover takeover

middot Independent audit (by supervisors and drug inspectors)

Products prone to theft abuse or misuse -

Some medicinesproducts are particularly prone to theft abuse or misuse These include expensive medicines (eg insulin) certain antibiotics and products prone to abuse or misuse like psychotropics etc

Such medicinesproducts should be stored adequately They require stricter record keeping and more frequent stock taki ng than others Periodic audits should be carried out to check for consumption against actual recorded use (registers prescription records stock records etc) to expose any theft or misuse bull26 Storage and stability of medicines Medicines are not stab le indefinitely They are stable for a specific period of time sometimes for a brief period Poor storage conditions accelerate the drug degradation (decomposition) Temperature light and moisture are the most important contributing factors for drug instability It is important to identify and be aware of the potential for instability There is a need to comply with storage requirements to ensure quality medicines for patients It is also important to offer advice to patients too about appropriate storage o f medicines at home The dispensing label should state the storage condition required and be backed up by a verbal reminder especially where special storage is required bull

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In case stability and storage problems are seen with formulations they should be reported immediately to the representative of the manufacturer and taken out of circulation till the stability problems have been resolved

The pharmacist can easily detect stability problems when products show change in appearance color odor settling of the product contents breaking of emulsions melting of creams oozing of contents from the containers and any such physical changes

3 STOCK CONTROL AND EXPIRY MONITORING 3 1 S t o c k C o n t r o l For economic reasons pharmacists do not like to have stock on their shelves for long periods of time The aim should always be to keep stock at a level that will just meet demand Normally most manufactured medicines have a long shelf life Even then it is essential that there is efficient stock rot ation so that the older stock is used first It is also a good practice to check the expiry date as an integral part of the dispensing process When short shelf life products are involved stock levels may have to be modified to prevent medicines regularl y expiring on the shelves

32 Stock rotation and expiry monitoring In order to avoid accumulation of expired and obsolete stock medicines should be stored and issued according to the following guidelines -middot The stock control system must record the ex p i r y d a t e a n d t h e d a t e o f r e c e i p t middot Stock must be stored so that earliest expiring batches are picked and issued first middot The First In First Out (FIFO) system - In this system the stock which is received

first is sold first This system however may not be useful for pharmacies because most of the stocks carry an expiry date For pharmacies the FEFO system is more practical

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middot The First Expiry First Out (FEFO) system - In this system the stock having an earlier expiry is sold first The stock with longer shelf life should be placed farthest to the back (or at the bottom in case o f sta c k e d b oxe s) T h is is pa r tic u la r ly impor ta n t with products that have short shelf lives such as vaccines some vitamins antibiotics etc and reduces losses due to expiry

middot E x p i r y dates should be noted on the stock record upon receipt Stock nearing expiry should not be accepted unless it can be used before expiry

Computerization and expiry monitoring In the pharmacy computerization facilitates both checking stocks and expiry mo nitoring and helps-bullbullKeeping a check on products nearing expiry bullbullKeeping a check on non- moving and slow moving products bullbullTo facilitate the removal of medicines nearing expiry from shelves in time to send them back to the wholesaler or supplier

Periodic checking for expiry The expiry date for medicinal products is a critical aspect in pharmaceutical dispensing and due importance should be given to it Periodic checking for expiry of medicines will ensure that the patient will never receive products that have crossed their expiry date During periodical checking of expiry the personnel involved should remove medicines that are nearing expiry bullbullIn -house threshold periods should be set and followed for retrieval of such medicines from the shelves bullbullSuch medicines should be stored separately These should either be dispensed immediately (thus ensuring that they are used before the expiry date) o r t h e y s h o u l d b e returned to the suppliers bullbullA separate area should be designated (cupboard or shelf)marked[FROZEN ZONE] which is adequately marked EXPIRED GOODS- NOT FOR SALE to store all expired stocks FROZEN ZONE

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Remember Expired medicines are a NATIONAL WASTE So stock only what you can sell Avoid expiries save precious medicines for the nation

Treatment and disposing of expired medicines bullbullProcedures need to be in place for the treatment of expired medicines bullbullThe expired medicines need to be collected and be sent back to the supplier or company for appropriate disposal bullbullRecords must be maintained for expired medicines and how they are disposed off bullbullIn case of medicines that are not returnable to suppliers procedures for disposal need to be followed by the pharmacy in conjunction with the FDA The following procedure can be followed if medicines cannot be returned to suppliers ( T h e b a s i c p h i l o s o p h y of appropriate disposal is to prevent their re- circulation and use) bullbullC u t t h e c o n t ainer in such a manner that the label is also cut In case of tablets and c a p s u l e s d e s t r o y them by disposing them in a bucket of water bullbullUse landfill procedures (deep burial into the ground as per stipulations of Medical Waste Disposal Act prevalent in the respective state) bullbullPour the liquids into the sink and wash away with sufficient quantity of water bullbullKeep a record of such disposal with full details of medicines destroyed Although these measures are usually adopted care has to be taken with such tr e a t m e n t a s studies have shown that flushing of medicines has resulted in tracessmall quantities of medicines being found in waterways and groundwater having potential health and environmental effects

4 O T H E R A S P E C T S 41 Design of storage areas The following important factors need to be considered in design of storage areas -middot The retail outlets in hot areas in summers should be air-conditioned Similarly in

a r e a s o f e x t r e m e c o l d t h e p r e m i s e s w o u l d r e q u i r e w a r m i n g e s p e c i a l l y i n w i n t e r s t o maintain cool temperatures The placement of air -conditioners and heating devices should be such that medicines are not directly exposed to the cold or heat

middot Due consideration should be given to storage requirements of formulations while designing shelves and cupboards in retail outlets Sufficient shelf height should be provided so that all liquid products can be stored vertically As far as possible the shelves should be covered with glass panels to protect medicines from dust and p r e v e n t r a p i d f l u c t u a t i o n s i n temperature

middot Medicines should be stored according to the storage instructions on the labels bullIt is ideal to have a door at the pharmacy entrance to prevent dust from coming in as well as reduceprevent cooled air from going out This may not however be considered feasiblepracticable by many pharmacy owners for fear that clients may not enter the pharmacy because the door may act as a barrier An air curtain is a good alternative to a door

middot There should be minimal direct sunlight falling on the products Particular consideration should be given to premises directly facing the sun

middot bullThe arrangement of lighting in the interior of the premises should also be in a manner that the lights are not focused on the products It has been shown that light causes not only chemical damage but also can catalyze physical changes like moisture uptak e by the products Care should be taken to ensure that only diffused light falls on them

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middot As far as possible provision should be made for a temperature and humidity indicator device in a pharmacy These devices are now easily available

middot Stability studies o f m e d i c i n e s p a c k e d i n b l i s t e r s h a v e r e v e a l e d t h a t i f t h e s e a r e exposed to light they tend to absorb moisture It is therefore necessary to store them in suitable cartons so that the blisters are not exposed to light Pharmacists should do this even if the manufacturer has not provided cartons

middot Light and temperature sensitive products should not be stored on counters where the light is intense or direct and there is no protection from temperature and humidity

42 Cleaning and maintenance i) Cleaning of storage areas

The storage areas of the pharmacy should be cleaned periodically and cleanliness should be maintained at all times The Standard Operating Procedure for cleaning should be designed and followed accordingly Schedules for cleanups should be laid down and adequate cleaning equipment should be made available

Tips for maintaining cleanliness middot Provide clean pieces of cloth for wiping at various locations in the pharmacy

Replace with clean cloth at regular intervals middot Keep separate pieces of cloth for floors shelves and medicines middot Use a disinfectant andor soap solution to clean floors middot Ensure removal of dust and prevent accumulation of dirt middot Ensure removal of cobwebs middot Use a vacuum cleaner for cleaning areas not easily reachable middot T a k e c a r e t h at breakages are handled and cleared effectively middot Observe the factors leading to waste generation in the pharmacy and take appropriate

measures to tackle the problem middot Record all cleaning procedures performed and maintain all the documents required

For ex a m p l e -bullbullThe floor of the pharmacy may be swept with a broom and swabbed with soap water every morning bullbullThe floor may be swabbed with a disinfectant every week bullbullThe entire premises including shelves and cupboards may be cleaned with a cloth (to remove dust and to check for medicines approaching expiry date or expired medicines) every three months bullbullAll the steps followed should be r e c o r d e d

The floor shelves drawers have to be cleaned and a check should be kept on dust cobwebs spillages due to breakage etc It is therefore essential to have SOPs for cleaning laying down cleaning frequencies allotting responsibilities and maintaining a daily record in the logbook to document all these activities

54

While cleaning dust settled on dosage forms like bottles tubes etc should be removed Before dispensing the products should also be wiped to remove any dust settled during storage

For refrigerators bullbullDefrosting and cleaning should be done at regular intervals bullbullSwitch off the refrigerator while cleaning bullbullCleaning should be done quickly and stocks put back immediately

i i ) Pest control Pests are a serious problem in India where insects reptiles and rodents (eg cockroaches l i z a r d s r a t s s i l v e r f i s h (Deemak - in Hindi ) etc) may find access to the pharmacy storage areas Insects like ants and borer ants may often attack wood in the pharmacy causing d am ag e to shelves cupboardsPest c ontr o l in a p h a r m a c y c a n b e a d i f f i c u l t t a s k b u t t o avoid possible contamination and physical damage to stock it is necessary to keep pests out of the pharmacy premisesPest control measures should be implemented with proper p r e c a u t i o n s t a k i n g u t m o s t c a r e t o a v o i d contamination of medicines

55

Th e following pest control measures c a n be ta ke n f r om tim e to tim e -bullbullRat bait and traps can be placed at various locations bullbullInsecticutors can be used on a permanent basis bullbullInsecticidal sprays and repellants can be used from time to time

i i i ) Fire precautions

Combustible trash such as cartons boxes and other packing waste must not be allowed to accumulate in the store Waste should be deposited in appropriate waste bins and be d i s p o s e d o f f o n a d a i l y b a s i s

F i re detection and fire fighting equipment must be maintained and regularly inspected The pharmacy personnel should receive adequate training in fire fighting techniques and emergency actionFire prevention measures should include a prominently displayed ldquoNoSmokingrdquo sign careful handling and disposal of combustible waste materials and checking of electrical connections at regular intervals

iv) Security middot Doors shutters of the pharmacy should be strong and be fitted with secure locks middot Counters should be designed so that unauthorized personnelclients do not have

access to areas where prescription medicines are stored Access to such areas should be restricted to the pharmacy staff

middot All the pharmacy staff handling supplies should be accountable for their ac t i o n s

56

middot bullSpecial care must be taken in case of Schedule X and manufactured drugs (under NDPS Act) Such medicines should be kept under lock and key and the key should be kept with the Chief Pharmacist or i n h i s a b s e n c e t h e s e n i o r p h a r m a c i s t

v) Breakagespillage and damaged product Products that have been damagedspoiled during storage and handling spillages and broken glassware should be disposed off according to procedures laid down by the pharmacy Broken and damaged products s h o u l d b e p l a c e d i n a segregated area to be returned to the supplier

vi) Inspection Senior staff should inspect all pharmacy areas regularly The shelves and drawers should b e c h e c k e d d a i l y f o r signs of pests and dust Ceiling and walls should be checked for dirt and cobwebs Stock should be checked on a regular basis for deterioration due to climatic conditions

43 Product recalls Products found to be defective should be quickly recalled (withdrawn from the market) The instructions are generally issued either by the manufacturer or the regulatory agency The level of recall is determined by both the degree of risk and the extent of distribution of the product and in India is mainly directed at the distribution chain

On receiving the details of the defective substandard spurious batchbatches of a medicine to be recalled from the manufacturer or the stockist or the FDA the pharmacy should immediately check if the particular b a t c h i s i n s t o c k a n d i f s o s u s p e n d i t s s a l e immediately

Similarly if the regulatory authority in the country bans a particular medicine or FDC the pharmacy should immediately check and remove all the different brands of that particular medicine under consideration

The details of medicines and their batches to be recalled should be available in the q u a r a n t i n e a r e a w h e r e stocks are received and checked This is to ensure that such medicines do not come into the pharmacy

middot The pharmacy should develop SOPs for recall of medicines middot The pharmacy staff should be immediately informed about such medicines and

the details should be displayed in writing in a prominent place in the pharmacy middot Rapid action helps avoid unnecessary exposure to such medicines once the

problem has been d e t e c t e d middot The progress of the recall procedure in the pharmacy should be monitored every

few days to ensure complete compliance middot All stocks of the recalled products should be stored separately from the saleable

stock These can be stored in the expiry cupboard segregated from the expired goods and be appropriately labeled ldquoRecal l e d G o o d s - Not for Salerdquo

The supplier should be notified and asked to replace defective products middot All the details of the procedures followed should be duly recorded in a Recall

Register maintained specially for the purpose The register should include d etails such as -middot Date of the recall middot Nam e of the product

57

bullbull

middot Details of the product (name of manufacturer batch number expiry date) middot Nu m b er of units purchased sold a n d sto c k in ha nd middot Reason for recall middot Nam e of the supplier to whom produc ts w e r e returned along with the date and quantity middot Name and signature of the designated personnel carrying out the recall procedure and recording details middot Name and signature of the chief pharmacist verifying the recall procedures and recording details 4 4 Returned medicines

Medicines may be returned to the pharmacy by clients due to the following reasons -bull

bullbull Unused medicines bullbull Course not completed bullbull Therapy changed by doctor bullbull Side effects experienced by patient bull

bullbull DamagedDefective medicines bullbull Missing or defaced label bullbull Missing tablets in a stripblister bullbull Leakage in bottles bullbull Leakage in strips bull

bullbull Expired medicines

Appropriate SOPs should be framed and followed for their acceptancerefusal and disposal middot bull For unused medicines returned by clients the p harmacy personnel should verify

that these were purchased from their pharmacy They should then be checked for integrity of the packing the dosage form and the expiry date and verified with the client whether they were stored in appropriate conditions This again is at the discretion of each pharmacy

middot The damageddefective medicines returned to the pharmacy should be taken back and stored separately Existing stock of the same product should be checked for similar defects

middot Expired medicines should be accepted from clients at the discretion of the pharmacist and be immediately shifted to the expired goods cupboard These can be stored segregated from the pharmacys own expired goods and be appropriately labelled ldquoExpired Goods returned by clients- Not For Salerdquo

It is advisable not to accept returned medicines requiring cold chain storage (refrigeration) because it cannot be ensured that the cold chain was maintained when the medicines were in the hands of the patientclient middot Appropriate adjustments in t he stocks should be made for medicines

returnedexchanged to update the inventory middot The medicines should then be returned to the respective shelves middot A lsquoReturned Goodsrsquo register needs to be maintained to record all details of returned

medicines

R egister should include such details as-

58

middot N a m e o f t h e p a t i e n t middot Nam e of the product and quantity r e tu r n e d middot Product details such as the batch number and expiry date middot Condition in which received middot Reason for returning products middot Compensatory measures taken wi t h r e s p e c t t o c l i e n t middot Action taken with respect to product middot Name and signature of the personnel accepting the returned medicines and recording details middot Name and signature of the chief pharmacist verifying the recorded details

What the pharmacist would have learnt from this module The storage of medicines is a critical factor in the distribution cycle bullbull Stocks received by the pharmacy should be quarantined in a separate area and necessary checks s h o u ld be performed to ascertain the qua lity a nd quantity of stocks received bullbull Whatever pattern and means of storage used the products should be stored so as to maintain their potency and integrity bullbull Storage conditions should be monitored and maintained on a regular basis bullbull Optimum stock levels should be maintained and regularly monitored for expiry bullbull The design of storage areas should facilitate appropriate storage of medicines bullbull Cleanliness should be maintained in the pharmacy bullbull Adequate measures should be taken in case of returned medicines and recalled products

Optimum storage of medicines is mandatory whether at the distribution stage at the pharmacy or ultimately within the homes of patients The pharmacist has an important r o l e t o p l a y i n t h e s t o r a g e o f m e d i c i n e s i n m a i n t a i n i n g d r u g p o t ency and efficacy and thus facilitating optimum therapeutic benefits Good Pharmacy Practice - IPA -CDSCO - WHO Appendix I Quality Assurance Templates of letters for use if found not of Standard Quality [Frozen and expired goods ]

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated To Name of the Supplier with address

Sub Not of Standard Quality GoMP-Supply of Drugs and medicines-(Codename) Return of Stocks to the Suppliers-reg(New drug policy 2009) Previous letterinvoice ref Sl No Drug Code Drug name

Manufacturing date Expiry date

Supplier address

B a t c h n o

The above items of PO nodated was drawn by the Drug Inspector (Place) on (______________date) as a statutory sampling and declared ldquoNot of Standard

59

Qualityrdquo on -(______________date) by the Government Analyst for the following reasons

- ldquoThe product sample do not confirm to IP specification for (Drug codename with respect to the content of drugrdquo

- ldquoThe product has already been blacklisted by TNMSC on -(______________date) for the failure of (quantity) of batches of drug codenamerdquo

As per the clause of the te nde r d oc um e nt ldquo I f the sa mple s d o not c onf o r m to statutory standardsthe tenderer will be liable for relevant action under the existing laws and the entire stock in such batch should be taken back by the tenderer within a period of 30 days o f t h e r e c e i p t o f t h e l e t t e r f r o m t h e v e n u e

The stock shall be taken back at the expenses of the tendererthe Procurement Authority have the right to destroy such Not of Standard Quality if the tenderer does not take back the goods within the stipulated time

The Procuring Authority will arrange to destroy the Not of Standard Quality drugs within 90 days after the expiry of 30 days mentioned above without further notice and shall also collect demurrage charges calculated at the rate of 2 per week on the value of the drugs rejected till such destructionrdquo

Hence we regret to inform you that you will have to take back the stocks available of the abovesaid batch at your own cost from the drug stores where you have supplied the above batch

Kindly acknowledge the receipt of this reference at once

P r o c u r e m e n t A u t h o r i t y Seal and Stamp

Copy to Ref No dated

1 ) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated13082010

To

Sub Frozen Drugs-ordered to return to the Suppliers-reg(New drug policy 2009) Previous letterinvoice ref

The following products which were earlier frozen have now been ordered to return to suppliers directly with permission from the State drug Authority In this regard the suppliers have been instructed to take back their failed batch from the drug store of the stores Hence you are now instructed to return the following failed batches to the suppliers by obtaining proper authorization letter and acknowledgements from them

60

Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

Kindly acknowledge the receipt of this reference at once

Procurement Authority Seal and Stamp

Copy to

Ref No dated 2) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated14092010

To

Sub Frozen Drugs-ordered to return to the Suppliers- for issue of gate pass after verification reg(New drug policy 2009) Previous letterinvoice ref

The following products which were earlier frozen have now been released Hence they may be issued Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

Kindly acknowledge the receipt of this reference at once

Procurement Authority Seal and Stamp

Copy to

61

Ref No dated 3) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated

To

Sub Stop instruction-reg(New drug policy 2009) Previous letterinvoice ref

Until further instructions stop issue all the batches of the following item Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

You must intimate the available stock in the stores of the said batch Number to the Procurement Authority immediately Also retrieve quantity if already issued

Procurement Authority Seal and Stamp

Copy to

Ref No dated 4) HOD Procurement Office of

62

Appendix II Material handling in drug stores

Rack approx rates and dimensions

S No

Item Description UOM Approx Rate

1 MEDIUM DUTY RACK SIZE 2900 H X 3090 W X 800 D IN MM (AS PER SPECIFICATION)

Each 2499800

2 MEDIUM DUTY RACK ADD ON UNIT FOR SIZE OF SR NO2

Each 2243100

To locate a Box no 3 Rack no 14 in row3

SAMPLE OF RACK no Bin numbering -------------- S a y R K 1 4 R o w 3 B o x 1 6

SAMPLE LAYOUT of RACKS in a Drug Stores

63

Sample of another warehouse of distribution warehouse system

64

65

Slotted Angle racks with bin cards

66

Plastic Pallets

Plastic pallets ar e l i g h t w e i g h t l o w- c ost and exceed industry standards for strength and durability

NOTE A pallet has bottom deckboards (see sketch) A skid does not have bottom

67

deckboards

Battery Operated Stacker

Electric Stacker Ehh (Manual Push Type) - Manual drive - Lifting electrically with Battery 12 V 88 Ah - For loading and un-loading of trucks - Battery and loading device built - in - Battery charge gauge and charging current gauge Simple and Easy Operation - Lifting and Lowering electrically direct on steering arm - Pulling and pushing through steering arm - Electrically operated relief valve on hydraulic aggregate Safe Operation - Emergency Off Switch - Constant lowering speed - Protection through lowering brake valve - Overload protection through overload brake valve - Load chains covered preventing pinching threat - Electrically interlocking during loading process - Secured battery compartment opens upwardly - Stable buffering of the steering arm in upright position - In accordance with EWG Guidelines 89 240 - In accordance with VBG 12b Prevention of Accidents

Pallet Truck [ Top ]

68

----------------------------------------------------------------------------------------------------------------------------

For Transport Of All Goods On Pallets Safe and Easy Operation - through single hand operation Lifting moving

lowering with steering handle - neutral position of the hydraulic possible - overload pressure relief valve Long Service Life - robust co n s t r u c t i o n

- special hardened axles - hardened chromium plated ram - maintenance free Easy Maneuverability - through rubber steering rollers - nylon fork rollers

A h a n d t r o l l e y

69

Trolley with plastic bins for several items del ivery

70

Digital Weighing balances

Balances amp Scales EF Seriers Precision Electronic Balance

71

1

Ice lined Refrigerators

600 litres refrigrator

72

Walk in cooler

vacuum cleaner

73

DIRECTORATE OF HEALTH SERVICES MADH YA PRADESH

No Q E q p O c t 7 7 Bhopal the 2 6 th October 1977

(E x t r a c t e d f r o m t h e G O and reproduced f o r 2 0 1 0 -11 to have clearity on process of

procurement )

To

The Deans

The Divisional Joint Directors of Health

Th e J o int Director of Ayurveda

The Administrative officer ESISIndore

The Superintendents of Medical College Hospitals

The Superintendents of Special Hospitals

The Civil Surgeons

The District Family Welfare cum Health Officers

The Principals RHFWTC

MADHYA PRADESH

Subject -Rules Orders for management of stores

The Government of Madhya Pradesh in the department of Public Health and family Welfare have by their order No 305847795-2877MedIII dated the 13 th

October 1977 issued Rules for the management of STORES These come int o force from the day they are received by the officer-i n- charge of an institution

It is desired that these Rules be followed strictly both in lsquoletter and spiritrsquo and no explanations would be accepted for non-compliance

Sufficient number of printed cop ie s a r e be ing se n t to you f o r d istr ibution a m ongst your subordinate staff concerned with the subject

A C Gaur For Director Medical Services

Madhya Pradesh

9

ACQUISITION OF STORES

The word Stores used hereunder applies generally to all articles expendable as well as dead stock of the nature of plant machinery instruments furniture fixtures medicines linen etc etc

Any authority which is competent to incur contingent expenditure may sanction the purchase of stores required (sub ject to his d e le ga tion of f ina nc ia l pow e r s) pr o vide d the following rules are observed-

(a) A Purchase Committee comprising of atleast three Gazetted Officers is formed for approving quantity and quality of stores required

( b ) An enquiry for the articles purch ased should be sent out to various manufacturers and dealers if the total of the order is for Rs 15000 or less In case the purchase order is likely to exceed Rs 15000 ldquoopen tendersrdquo be called through news paper publicity ( f igur e s p e r ta in to 1 977)

(c) Stores s h o u l d n o t b e p u r c h a s e d i n s m a l l q u a n t i t i e s and often if such store is not perishable

( d ) Requirement of the whole year to be worked out a nd n o stor e sh ould b e p ur c h a se d in e x c e ss o f the requirement

(e) P u r c h a s e s h o u l d b e m a d e i n t h e m o s t e c o n o m i c a l manner but q ua lity ne e d not be sa c r if ic e d in the interest of the economy

(f) The details regarding the quality desired and expected purchase quantity should be mentioned in t h e e n q u i r y

(g) Purchase order should not be split up to avoid the ne c e ssity o f obta ining th e sa nc tio n o f t h e h i g h e r authority

( h ) The date and time of opening of the tender should also be published and in case the tenderers desire to be p r e se nt o n th e o c c a sio n th e y should b e a llo w e d t o d o s o

( i ) Mere initialing on the covers of the tenders is not sufficient All the Purchase committee members s h o u l d s i g n o n e a c h a n d e v e r y p a g e o f t e n d e r q u o t i n g t h e r a t e s A n y r a t e s w h i c h h a v e b e e n overwritten by the tenderer should not be c o n s i d e r e d u n l e s s t h e y b e a r t h e t e n d e r e r rsquo s s i g n a t u r e and subsequently signed by a member o f t h e Purchase committee

( j ) A list of tenders opened should be made out and t a l l i e d w i t h t h e o n e o f t h o s e r e c e i v e d i n t h e o f f i c e Such a list should be signed by all the members of the Purchase committee

( k ) A comparative statement is then made and lowest t e n d er i s a c c e p t e d s u b j e c t t o q u a l i t y o f f e r e d b e i n g

10

satisfactory Samples of non perishable articles should be preserved safely under lock and key for comparison till the contract for supply is in force

( l ) R e a s o n s for rejecting the lowest tender and accepting the h i g h e r o n e s h o u l d a l w a y s b e r e c o r d e d in writing by the Purchase Committee

(m) No reason for rejecting the lowest tender need to be communicated to the tenderer

( n ) Every purchase order should clearly mention that the articles ordered shall be accepted subject to t h e approval of the Purchase Committee

( o ) Rules regarding deposition of earnest money and security money should be observed

( p ) For emergent purchases in public interest when there is no time to observe Store Purchase Rules purchases should be made up to Rs 2 5000 (refers to year -1 9 7 7 ) a t a t i m e A s f a r a s p o s s i b l e t h i s practice should be avoided

II PLACING OF ORDERS (a) For medicines and such other articles which the Medical Stores Depot Bombay

supplies order be placed with them at a specified time ( b ) For articles not on the Bombay Stores Depot Bombay lsquolimitedrsquo or lsquoopenrsquo

tenders be invited as the case may require It would be preferable to place orders on the manufactures or their authorized distributors

(c) For placing the orders on PSUrsquos Laghu Udyog Nigam or Organisations approved by the State government no tender needs to be invited

( d ) Price preference upto 10 is available to Small Scale Industries of this State only(not applicable as per New drug policy 2010 -1 1 )

III RECEIPT OF STORES All materials received should be examined counted measured or weighed as the

case may be when the delivery is taken The stores thus verified be may be immediately entered in the stock register Book under proper headings and this fact should be recorded on the body of the bill mentioning the page number of the Stock Book It should also be mentioned whether the quality and the quantity are correct as per the requirement Soon after the receipt each item be stamped with the initials of the institution

IV CUSTODY

(a)The head of the institution should ensure suitable accommodation for keeping the stores with a view to prevent losses through theft accident fraud or otherwise

(b) Separate Stock Accounts should be kept of-( i ) D e a d S t o c k-such as plantmachineryfurniture equipmentinstruments

etc (ii) Expendible items such as medicineslinenrubber goods etc (iii) Perishable articles

(c ) all recepts and issues in the stores stock registers should be on the authorityand under the signature of a respon sible officer deputed for the purpose

11

V ISSUE OF STORES (a) When materials are issued from stock the officer -i n ndashcharge should ensure that the indent is in proper proforma (Annexure A) and the person taking delivery is an authorized one (b) The issue vouchers (Annexure B) for articles should be prepared in triplicate by one single stroke of pen The first copy will remain with the records of the stores The second and third copies will go to supplies The second copy will be retained by the person receiving the supplies and the third copy will be returned by the receiver to the stores after making entries of hisher stock book page number etc against each item ( C ) E v e r y t i m e i s s u e b e r e c o r d e d i n t h e s t o c k b o o k o f t h e s t o r e s w i t h s i g n a t u r e s o f t h e O f f i ce r i n -charge

(d) Every issue made from the Central Stores to other institution should show cost of article preparation of Annual Stores Account at a later date

VI Maintenance of Stock Books (a) Stock book should be kept under the charge of a responsible person and should be

saved from loss and destruction ( b ) While making new entries in the main Stores Stock book cost of each item

should be entered though this need not be done in the case of registers in Wards Operation Theatre Out door etc

(c) There should b e n o o v e r-writing or interpolation or smudging of figures Any f i g u r e i f i t i s t o b e c o r r e c t e d s h o u l d b e c l e a n l y c u t a c r o s s a n d t h e n e w f i g u r e should be written by its side or below it under proper attestation

( d ) Stock books should always have a page count(each page be numbered) A certificate showing the number of pages be given on the first and the last page under the signatures of a Gazetted Officer

(e) Receipts issues and balances should be worked out for every item and attested regularly by the Offic er-i n -Charge of the Stores

(f) In the receipt column details regarding the size quality and any special features if t h e r e b e s h o u l d b e r e c o r d e d e g i n t h e c a s e o f A l m i r a h i t s s i z e a n d w h e t h e r i t i s of Steel or Wood

(g) In the Stock-book of library Edition and the ye a r o f p ublic a tion of th e book should always be mentioned

( h ) In case of medicines having an expiry date a list of such medicines be made out and should be checked every week Two months prior to the date of expiry if the s t o c k i s s t i l l f o u n d s u f f i c iently high intimation should be given to Directorate of Health

(i) N o r e m o v a l o f d e a d s t o c k s h o u l d b e m a d e f r o m t h e s t o c k ndash B o o k u n l e s s s o a u t h o r i z e d b y t h e c o m p e t e n t A u t h o r i t y

(j) While making a new Stock book and transferring the stocks therein it should ensured that the page number of the old stock book is shown in the new stock b o o k a n d s i m i l a r l y p a g e n u m b e r o f t h e n e w s t o c k b o o k i s m e n t i o n e d i n t h e o l d one This has to be done to facilitate cross checking whenever desired

( k ) T h e r e h a v e t o b e d i f f e r e n t s e t s o f proforma for dead stocks and for expendable items

Annexure ldquoCrdquo is for former and Annexure ldquoDrdquo for the latter varieties

12

VII PROCEDURE OF INDENTING FOR WARD amp OTHER SECTIONS OF THE INSTITUTION

(a) There has to be an Indent Book with every such section wh ich receives and issues medicinesequipment

( b ) The indent shall be prepared by the nurse Compounded -i n -c ha r g e of th e WardSection in te single copy on the Performa (Annexure A)

(c) The indent so prepared will be signed by the medical officer resident ndash i n c h arge or in his absence by a doctor senior to him but associated with the ward section

( d ) The indent shall then be signed by the head of the institution (Superintendent or the Civil Surgeon as the c a se ma y be ) o r b y his A ssista n t if th e la tte r is so authorized in writing

(e) The indent book is then presented to the main Store for effecting issue (f) The Store will then prepare issue vouchers (Annex B) in triplicate as directed

in Paragraph V (b) supra The supplies and the Indent Book are taken back by the Ward Section- i n - charge after signing the first copy of the issue voucher

(g) Te supplies after arriving in the WardSection shall be entered on the WardSection stock register which is prepared on a proforma (Annexure E) and page number of each entry be shown o n t h e 2 n d a n d 3r d copies of the Issue

voucher The 2 n d copy of the voucher is to be retained in a file in the wardsection but the 3r d c o p y s h o u l d b e r e t u r n e d t o t h e s t o r e b e f o r e s u b m i t t i n g a fresh indent The Store has to be maintain separate files of the 3 r d copies Wardsection-wise

VIIIHOW OFTEN TO INDENT

(a) A wardsection ndash i n -charge should work out an average weekly expenditure of each item and efforts be made to replenish the WardSection stocks every week

( b ) T h e M a i n s t o r e i n o r d e r t o a v o i d h e a v y rush of work should fix a day of issue for each major specialty T w o or th r e e minor spe c ia ltie s c a n be gr o upe d f o r one day

IX EMERGENT INDENT It is very likely for unforeseen reasons either the weekly indent of WardSection stock might get exhausted earlier or something which was not there in the lsquoweekly indentrsquo is required Under such circumstances an ldquoEmergent Indentrdquo could be made out in the usual manner but under the signature of the Unit-i n- chargeconsultant and it must be countersigned by the head of the institution (and not by his assistant) These supplies have also to be entered in the wardSection stock books like others

13

X HOW TO INDENT

(a) The ward Section -i n - c h a r g e s h o u l d e n s u r e t h a t t h e s t o c k s u n d e r t h e i r c h a r g e a r e not unnecessarily large and only a realistic quantity is indented once a week

( b ) The indent should not be made out in the names of the patients or by bed numbers The indent should be for the Wardsection as a whole

XI KEEPING OF RECORDS IN WARDS AND SECTIONS

(a) A set p r o f o r m a ( A n n e x u r e E ) s h o u l d b e u s e d i n t h e w a r d s e c t i o n f o r s h o w i n g u p receipts and issues Balance of expenditure for each item to be drawn out every morning by nursecompounder in charge before writing out the Indent or before restarting work The medica l O f f ic e r r e side nt in c ha r g e sh ould a tte st th e e ntr ie s after satisfying himself- by random checking at least once a week

( b ) To support the above mentioned expenditure the Bed head Tickets (treatment charts) are very important Each medicine prescribed should be legibly written indicating the total quantity prescribed if the medicine is to be deleted from treatment the fact should be mentioned as to how much of the drug was issued to the patient before switching on to another drug The suggestion is that a separate treatment card be maintained for each indoor patient ( Annexure ndash G) A summary s h o w i n g t h e t o t a l a m o u n t o f t h e p r o p r i e t a r y d r u g s c o n s u m e d b y t h e p a t i e n t d u r i n g is hospital stay be worked out and noted in the summary card

XII ACCOUNT ABILITY OF DRUGS BROUGHT BY THE PATIENT OR RECEIVED IN DONATION BY THE WARDSECTION _IN -C H A R G E

The drugs receoived from the non - governmental sources should be entered on the receipts side of the WardSection Sto c k b ook a n d issu e s to show n a s in th e o the r cases on the issues side

XII RSPONSIBILITY OF STORES AT VARIOUS LEVELS (a) The head of the institution shall be held responsible for non-observance of

rulesprocedures laid down by the Government ( b ) The Medical officerresident in charge of the stores and the store keeper shall be

held responsible for any irregularity found in the stores or for ignoring the ordered pattern of working It shall be the duty of the Medical officer Incharge of the Stores to occasionally check the WardSection Stock-b o o k s t o t a l l y t h e e n t r i e s made in the 3 r d copy of the Issue vouchers [as laid down under V (b)supra ]

(c) The Medical officerresident in charge of the WardSection shall be responsible for irregularities in indenting stocksfor maintaining stocks much in excess of the req uirement and for improper keeping of BED HEAD TICKETS (treatment chartsCards)

( d ) The NurseCompounder ndash i n -charge of the WardSection shall be responsible for shortages in stocks for putting up inflated indents and or for not taking into account medicines b rought by the patientson the WardSection stock-books Heshe shall also be held responsible for ensuring proper distribution of medicines to each and every patient under his her charge

XIV DISTRIBUTION OF MEDICINES FROM OUTDOOR DEPARTMENT (A) ( a ) T h e r e are proprietary and non -proprietary medicines (like mixtures ointments

and lotions) which are to be distributed gratis to patients 14

(b) The Outdoor incharge shall arrange to maintain a stock of common drugs (list of which shall be prepared by the Head of t he Institution) and arrange to replenish the stocks once a week as has been laid down for wards (c) No proprietary drugs shall be issued on the prescription of an intern ( d ) The Head of the institution shall make out a list of drugs which can be issued on

the prescription of a houseman from the Outdoor stock without the countersignature of any other authority

(e) The residents can prescribe any drug from Outdoor stock without the counter signature of any authority

(f) The Consultants can prescribe any drug to any ot h e r o u t e r p a t i e n t e v e n i f i t i s n o t s t o c k e d i n t h e o u t d o o r b u t t h i s s h a l l h a v e t o b e c o u n t e r s i g n e d b y t h e h e a d o f t h e institution for issue from The Main Store

(B) T h e p e r s o n i n c h a r g e o f t h e O u t d o o r m e d i c i n e s s t o c k s h a l l k e e p a r e c o r d o f t h e q u a n t i t y o f t he medicines issued to each patient and instead of writing the name and other details e may only put down the Registration number of the patient and the quantity issued

At the end of the day he must work out the total expenditure of eac item and draw it s balance

The Medical officer in charge of the Stores and the Head of the institution sould check these records at least once a week and affix is signature to confirm their inspection

(C ) No proprietary medicine shall be issued without a valid issue s l i p ( A n n e x u r e- F)

(a) For Housemen the slip would be of brown colour ( b ) For residentsDemonstrators it shall be of pink color (c) For consultants the issue slip should be white ( d ) All issue slips should be printed and pages serially numbered (e) T h e d o c t o r s t o w h o m s u c h i s s u e s l i p s w o u l d b e i s s u e d s h a l l b e h e l d

responsible for their sa f e ke e ping a n d th e y w ould e n su r e tha t th e se slip s would be printed and serially numbered

(f) The doctors prescription slips (for issue from hospitals) of proprietary drugs be prepared in du plicate with the help of carbon One copy should be given to patient for obtaining medicines from the Stores and the other would remain in the Doctors Prescription Slip book

(g) Every issue Slip should be signed and below the signatures a rubber s t a m p s h o w i ng name and designation be affixed The Store people would n o t h o n o u r s l i p u n l e s s t h e n a m e o f p r e s c r i b e r i s c l e a r a n d h i s a t t e s t e d signatures are available to stores

( h ) The Store Staff would file prescription slips of each doctor separately to facilitate the scrutiny at least once a month by the Head of the Institution Such a Scrutiny would reveal over prescribing of or injudicious use of drugs

(C) Proprietary medicines should not be issued for more than three days requirement at a time The only exceptions being cases for cancer pulmonary tuberculosis and leprosy In exceptional cases an officer not below the rank of a Consultant can prescribe for more than 3 days but after the countersignatures of the Head of the Institution

15

XV LOSS BREAKAGE DAMAGE ETC

(A) Any loss of public money departmental revenue of receipts stamps stores or other property held by or on behalf of the Government caused by defalcation or otherwise discovered in an office or institution should immediately be reported by the officer concerned to the head of department through his immediate superior as well as to the Accountant General if the loss exceeds Rs 20000(fig of 1977) (for Proforma see Annexure I)even when such loss has been made good by the party responsible for it Such reports must be submitted as soon as possible and soon after suspicion arises that there has been a loss they must not be delayed while detailed enquiries are made

When the matter has been fully investigated further and complete report should be submitted of the nature and extent of loss showing the errors or neglect rules by which such loss showing the errors or neglect of rules by which such loss was rendered possible and prospects of effecting such recovery

The s ubmission of such a repot does n o t d e b a r t h e l o c a l a u t h o r i t i e s t a k i n g f u r t h e r a c t i o n which may be deemed necessary like handing over the case to the police

Every Government servant should realize fully and clearly that he will be held personally responsible for any loss sustained by the government through fraud and negligence on is part and that will also be held personally responsible for any loss arising from fraud or negligence on the part of any other Government servant to extent to which it may be shown that he has contributed to loss by his own action or negligence

A s s o o n a s s h o r t a g e i n s t o c k o r l o s s i s d i s c o v e r e d a p a r t f r o m r e p o r t i n g t h e m a t t e r a responsible officer should be deputed to investigate the matter

W h e r e t h e r e i s n o l i k e l i h o o d o f a d e l i b e r a t e t h e f t b u t l o s s i s a result of neglect onlythe loss should be made good by the person on whose charge or custody the article lost remained

(B) As soon as damage or breakage of Government property is detected certain steps mentined under should be undertaken-

(a) A p r o m p t t h o ro u g h i n v e s t i g a t i o n i n t o t h e c a u s a t i o n o f b r e a k a g e o r d a m a g e s h o u l d be undertaken by the doctor-i n -charge of the WardSection or by the Head of the Institution

( b ) The investigating officer should draw conclusions as to whether the breakagedamage has been a result of-

(i) C a r e l e s s a n d n e g l i g e n t h a n d l i n g ( i i ) Unpredictable action of the patient for whom the equipment was

being used (iii) Accidental ( i v ) Manufacturing Defect

A report is then prepared in duplicate by person in charge of the article under question on the lsquobreakage and loss proformarsquo (See Annexure H)

16

These reports have to be signed by the investigating officer and are to be then submitted to competent authority for suitable action One copy which is returned is to be kept with the Stock Register In cases where the b r e a k a g e o r d a m a g e i s o f s u c h b i g g e r d e g r e e t h a t s atis factory repairs are not possible a n d if suc h b r e a k a ge o r da m a ge is o f su c h a de gr e e that satisfactory repairs are not possible and if such breakage or damage has been caused-

( i ) B y a G o v t s e r v a n t because of negligent or careless handling cost of the article should be recovered from him and credited to the treasury (ii)On account of reasons mentioned above that is un predictable action of the patient accidental or manufacturing defectthe article could be written offsubject to powers delegated to the concerned for such purpose

(C )Shortages detected during biannual physical verification of the Storeshave to be dealt in a similar manner

(D) it shall be at discretion of the competent authori ty (who is empowered to write off the loss) to reduce the amount of recovery upto 50 of the cost of article provided that before arriving at such a decisionhe has taken into account the following points (a) Normal life span of the article under questi on (b) Period for which it has been in use (c ) Condition of the article at the time of loss or damage and (d) Whether it was on account of careless or negligent act or not

XVI PROCEDURE FOR WRITING OFF STORES

(a) When any Stores become unserviceable otherwise than in ordinary course or by fair wear and tear their value should be treated as loss to the Government and in such cases cost should be recovered from the person responsible for his negligence

( b ) A s t r i c t w a t c h s h o u l d b e k e p t o n t h e m e d i c i n e s w h i ch bear an expiry date and if there is no likelihood of their being utilized locally intimation of the fact should be sent to Directorate of Health services and also to all o t h e r d i s t r i c t s s i m u l t a n e o u s l y s o t h a t t h e y c a n b e p u t t o u s e b e f o r e t h e expiry date In the event such a course is not followed and the Government i s p u t t o l o s s c o s t o f t h e m e d i c i n e i n q u e s t i o n s h a l l b e r e c o v e r e d f r o m t e defaulter

(c) For declaring articles as unserviceable a Committee of three members should be formed in each officeinstitution This Committee should examine each and every article brought before it and should record full reasons for condemning them and also say how the articles condemned have to be disposed of-whether by sale (by public auction) or otherwise

I f t he local Authority is not competent to write off the articles condemned by the Committee it should send the proposal to the higher authority for suitable a c t i o n

17

In Institutions where there is only one doctor a list of articles to be condemned should be p r e p a r e d a n d o r d e r s o n i t b e o b t a i n e d f r o m t h e inspecting authority during inspection

While preparing any list of articles for condemnation details regarding the date of purchase date of receipt period during which it remained in use usual life of the article and its purchase price should be noted against each item

( d ) The condemned articles should not be struck off the Stock Register till the competent authority sanctions its write ndashoff Details of Authority under which the article has been written off should be mentioned in stock register

XVII DISPOSAL OF WRITTEN OFF ARTICLES

Articles like linen should be torn into strips 10cm width so that they could be burnt or given to Government Jails for making carpets

Items like bed -pans bowlsurine po ts etc should be crushed and kept for auction

Brass utensils have also to be crushed to destroy their shape and could be either auctioned or after inviting rates from several dealers could be locally sold to highest bidder

In case when condemned ar ticles have to be sold by public auction they should be stored safely and the Government Auctioneer be intimated In case he expresses his inability to undertake the auction the officer should proceed with the auction departmentally The sale proceeds in either case should be credited to the Treasury as miscellaneous receipts under the Proper head of account

XVIII PHYSICAL VERIFICATION (a) The stocks held by officesinstitutions in various sections should be physically

verified twice a yearin the months o f April and October ( b ) Checking should be done by an officer other than te one who holds the charge of

Stores (c) Verification should be done in presence of officer holding the charge of Stores ( d ) All discrepancies found during the verification should be properly investigated

and accounted for

(j) Any excess detected during verification should be entered in the Stock book as Receipts with the remark ldquo Excess found on verificationrdquo

(ii)any shortage should be noted in issues column of lsquo Issuesrsquo described as lsquoshortage fou n d o n v e r i f i c a t i o n rsquo

XIX ANNUAL STORES ACCOUNT This account should be prepared according to the instruction issued from the department from time to time This should account for the outgoing financial year on the following lines -(a) Cost of the articles under various heads on the last day of the previous

year 18

( b ) Cost of the articles under the various Heads Received during the year (c) Cost of various articles written off during the year under review ( d ) Cost of the articles on the last day of the year or on the firs t d a y o f t h e

financial year following

19

Annexure A WardSection Indent Register No Issued on

Name of institution Page Folio No

Serial no Name of Article Quantity in Stock

Quantity required

Prepared by Approved by Recd by Note-Indenting Officer to sign and affix seal with name and

designation below the last item to avoid additions in one strokeno issues to be made by storesif Issue vouchers of

previous Indent has not been returned back by the WardSection

20

Annexure B Issue Voucher No (printed number)

Supplied to Wardsection Date

Indent no

Serial no Name of Article Quantity in Stock

Quantity required SB No

Stores-in MO Resident in Sign of charge charge WardSection

NurseCompounder Prepared by Recd Approved by by

Note-Indenting Officer to sign and affix seal with name and designation below the last item to avoid additions in one strokeno issues to be made by storesif Issue vouchers of previous Indent has not been

returned back 1st copy-Stores 2nd copy -Wardsection3rd copy-Tobe reurned to sores with Stock book entries

21

Annexure C

STOCK REGISTER FOR DEAD STOCKS

SERIAL NO DATE OF RECEIPT

Article with description

No of pieces Cost Details of

Bill Signature No Disposed

Date of disposal

Manner of Disposal

with Authority

Value realised Signature

1 2 3 4 5 6 7 8 9 10 11 12

P r e p a r e d B y C h e c k e d b y A p p r o v e d b y

Date Designation Name of Institution

22

Annexure D

STOCK REGISTER FOR EXPENDABLE ITEMS Name of article

Date

From where

received with cost

Quantity Signature To whom issued Quantity Balance Signature

1 2 3 4 5 6 7 8

23

Annexure E

Receipt amp Issue Register for WARDSSECTIONS (one or more pages as per requiremnt for each medicine)

NAME OF MEDICINE RECEIPT ISSUE

DATE Quantity In Stock

Date of

Issue

Issued toMention Bed no amp

quantity (in bracket) (For

Outdoor cases give Regd No)

Balance Signature

24

Annexure -F

OUTDOOR FREE MEDICINE SLIP In Duplicate

Name of Patient Registered No Date

Sr no Name of Medicine Quantity

Seal amp sign of doctor

25

Annexure-G

TREATMENT CARD

WARD NO

NAME OF PATIENT BED NO DATE amp TIME OF ADMISSION DATE amp TIME OF DISCHARGE

DATE MEDICINES PRESCRIBED SIGNATURE

26

ANNEXURE -H

PROFORMA FOR BREAKAGE amp LOSS

NAME OF OFFICEINSTITUTION DATE PLACE

SRNO NAME amp

DESCRIPTION OF ARTICLE

COST DATE OF PURCHASE

REASON CAUSE OF BREAKAGE

RECOMMENDATION OF INVESTIGATING AUTHORITY

Signature

Orders of the Competent Authority

Signature

27

Annexure ndash I Loss- Procedure for Reporting

1 The exact nature of the defalcation 2 The full extent of loss 3 The actual period covered by the defalcation 4 The defects in the negle c t o f r u le s by w hic h the loss was rendered possible

and circumstances which facilitated the defalcation 5 The names of the officials held personally or technically directly or

indirectly and wholly or partially responsible for the irregularity c o m m i t t e d i n t h e c a s e

6 Whether the c a s e a s b e e n J u d i c i a l l y t r i e d i n a c o u r t o r n o t i f s o c o p i e s ( i n duplicate) of the Judgment may please be furnished Copy of police report may also be furnished

7 The remedial measures adopted as safeguards against the losses hereafter 8 The prospects of re covery of the loss and he action taken to effect

recovery together with the amount recovered 9 Head of Account to which the Loss is debitable may be informed

Signature of Head of Office with seal

NoteA copy of this report is to be sent to AGMPThis is as per M P Finance Code Vol I

28

STORAGE AND STOCK MANAGEMENT

29

Foreword

The New Drug Policy 2009 is being implemented in the State of Madhya Pradesh

In order to have a proper procedure for Storage maintenance and expiry management of the drugs it is necessary to follow Good Storage Practices with Standard Modules for pharmacistStore keepers

Proper guidelines on Storage Practices can lead to better Stores and inventory upkeep with medicines being properly stored in racks with proper cleanliness and hygiene

This is a step towards storage maintenance and expiry management at the various stores in the state Looking forward to see that the heads of all health facilities take benefit from this module

D ir e c t o r M e d i c a l S e r v i c e s

30

INDEX

Sr No P a r t i c u l a r s P a g e

1 S T O R A G E A N D S T O C K M A N A G E M E N T 4

1 Quarantine and checking of stocks 11 Quarantine area 12 Checks to be carried out on new stocks

2 S t o r a g e 21 Need for proper storage 22 Different patterns of storage 23 Different means of storage 24 Temperatureclimatic conditions 25 Special storage of supplies 26 Storage and stability of medicines

3 Stock Control and Expiry Monitoring 31 Stock control 32 Stock rotation and expi r y m o n i t o r i n g

4 Other aspects of storage 41 Design of a storage area 42 Cleaning and maintenance 43 Product recalls 44 Returned goods

2 A p p e n d i x 1 Templates of letters for use if found not of Standard Quality [Frozen and expired goods ]

Frozen Drugs-ordered to return to the Suppliers-reg(New drug policy 2009)

Frozen Drugs-ordered to return to the Suppliers- for issue of gate pass after verification reg(New drug policy 2009) Stop instruction-reg(New drug policy

2009) Appendix II Material handling in drug stores

31

3 PROCUREMENT ndash Government Order Relating to

the Management of Stores

(Reproduced for reference material on basic

procedure in decentralized system followed by

Health facilities in 1977)

54

F L O W C H A R T S f o r a BI R D S E Y E V I E W o f

P R O C U R E M E N T

5 5

ACQUISITION OF STORES 6 1

PLACING OF ORDERS 6 2

RECEIPT OF STORES 6 2

CUSTODY 6 3

ISSUE OF STORES Maintenance of Stock Books

6 3

PROCEDURE OF INDENTING FOR WARD amp OTHER SECTIONS OF THE INSTITUTION

6 4

HOW OFTEN TO INDENT 6 5

EMERGENT INDENT 6 5

HOW TO INDENT 6 5

KEEPING OF RECORDS IN WARDS A N D S E C T I O N S

6 6

ACCOUNTABILITY OF DRUGS BROUGHT BY THE PATIENT OR RECEIVED IN DON A T I O N BY T H E WARDSECTION _IN - CHARGE

6 7

RESPONSIBILITY OF STORES AT VARIOUS LEVELS

6 7

DISTRIBUTION OF MEDICINES FROM OUTDOOR DEPARTMENT

6 7

LOSS BREAKAGE DAMAGE ETC 6 8

PROCEDURE FOR WRITING OFF STORES 6 9

DISPOSAL OF WRITTEN OFF ARTICLES 7 1

FORMATS TO BE USED 7 3 - 81

32

STORAGE AND STOCK MANAGEMENT The expiry periods of pharmaceutical products have meaning only if the products are stored under proper conditions otherwise products are likely to lose their potency before the actual date of expiry

A pharmacist is a vital link in the distribution chain for pharmaceutical products The medicinal products remain for a long period during the distribution cycle at the wholesaler and at retail pharmacies It is therefore very important to maintain proper storage conditions in these units

Every community pharmacy however large or s mall needs to store and manage its medicine stocks effectively There must be systems to ensure

middot bullbull Secure storage middot bullbull Clean and correct environmental conditions during storage middot bullbull Accurate and effective record keeping middot bullbull Effective stock rotation and expiry monitoring middot bullbull Effective fire and theft prevention middot bullbull Effective rodent pest control

For easier un derstanding this module has been divided into the following sections

1 Quarantine and checking of stocks 11 Quarantine area 12 Checks to be carried out on new stocks

2 S t o r a g e 21 Need for proper storage 22 Different patterns of storage 23 Different means of storage 24 Temperatureclimatic conditions 25 Special storage of supplies 26 Storage and stability of medicines

3 Stock Control and Expiry Monitoring 31 Stock control 3 2 S t o c k r o t a t i o n a n d e x p i r y m o n i t o r i n g

4 Other aspects of s t o r a g e 41 Design of a storage area 42 Cleaning and maintenance 43 Product recalls 44 Returned goods

33

1 QUARANTINE AND CHECKING OF STOCKS

11 Quarantine Area D r u g S t o r e pharmacies receive stoc k s f r o m su pplie r s a c c or d ing to pur c h a se o r d e r s T he stock that is received must be visually checked for quality and quantity The stocks must be kept in a separate area until the checking is done to avoid intermixing with existing stock This necessitates the presence of a separate area within the pharmacy w h e r e i n t h e storage and other checking of stocks can be performed This area is called the QUARANTINE AREA This area should be marked and identified adequately to distinguish it from other areas

The area may be marked using different means 1 ) A s m a l l board saying Quarantine on a separate table used exclusively if it is in the middle 2) A board on the wall if the table on which the quarantine stock is placed is against the wall

middot Stock received from wholesalers should be immediately transferred t o t h e Quarantine Area

middot In the Quarantine area the stock may be stored on racks shelves or in cupboards to prevent ingress of moisture dirt and other contaminants

middot Regular stocks from the pharmacy should not be left kept in the quarantine area Special care has to be taken in case of refrigerated medicines supplied by the suppliers so tha t the y do not remain in the quarantine area for long periods of time They should be immediately checked on receipt and transferred to areas for refrigerated storage s o a s to maintain the cold chain bull

Advantages of having a separate Quarantine Area middot Avoids cross mixing of newly arrived stock from existing stock till it is checked middot Lays stress on checking the quality of the stock received middot S to ck checking ensures t hat defective andor expired goods do not enter the storage areas

34

bullbull

bullbull

12 Checks to be carried out on new stock

Unpacking and checking stock

Supplies received should be unpacked and checked in the quarantine area Staff doing the checks should be adequatel y trained in what they have to check when stock arrives

Checking should be seen not simply as counting the units received but as a part of the quality assurance system bullThis should include middot Visually inspecting the packaging middot Checking the integrity of containers middot V erifying the completeness and leg ibility of la b e ls ( a ppr o ve d dr u g name strength any special storage instructions and expiry date)

bull

The expiry dat e should be checked to ensure that there is adequate shelf life remaining

Supplies should be individually checked using a checklist 35

Checklists

36

The wholesaler supplying the product should be notified immediately in case of any discrepancies ( and the details should be recorded in a register) and sent in a written format to the supplier It should include middot Missing boxes or cartons middot O p en tampered boxes or cartons middot Missing supplies middot Differences in the actual quantity and the quantity shown on the packing middot Additional medicines that had not been ordered but have been supplied middot D a m a g e d b r o k e n o r p oor quality medicines middot Any other discrepancies

The purchase invoices are an important aspect to be considered The invoiced documents should be signed and filed for reference as per the Drugs and Cosmetics Act and retained for at least 3years

If the wholesaler supplies medicines as an emergency without a bill or against a delivery challan

middot The supplies should be checked for integrity and inspected for damage middot The details of supplies received should be recorded middot The supplier should be asked t o send the bill as early as possible middot When the bill is received it should be checked against the details recorded and anomalies if any should be reported to the supplier

To keep a track of the received stock maintaining a S t o c k R e c o r d C a r d c a n b e very useful The entries in the stock record card can be made while checking the stock received STOCK BIN in the stores should have Stock record card

Maintaining a stock card for every product may not be very practical for a retail pharmacy however it could be maintained for costly medicines Nowadays it is much more practical and easier to maintain records using computers

The pharmacist should ensure that medicines manufacturedmarketed by a company are received only through an authorized distribution network of that company This is important to prevent spurious and counterfeit drugs from entering the pharmacy

37

2 STORAGE 21 The need for proper storage The storage of medicines and other products is an important requirement of Good Pharmacy Pr actice Appropriate storage of medicines is essential -

middot bullTo ensure that the potency is maintained middot bullTo prevent deteriorationspoilagedegradation middot bullTo ensuremaintain physical integrity

To ascertain that the quality and safety is maintained throughout their shelf life Storage requirements need to be considered on 2 aspects

a) Integrity of medicines Medicines should be stored in such a way so as to maintain their integrity and potency middot Maintain the right temperature required middot Protect from excessive humidity middot Keep medicines away from direct sunlight middot Protect from pests and rodents

b) Physical location middot Should be easy to locate middot Accessible middot Orderlysystematically placed

2 2 D i f f e r e n t p a t t e r n s o f s t o r a g e The pharmacist could follow any of the different patterns of storage The pattern of stora ge should be selected in such a way that it facilitates speedy and efficient dispensing of medicines

The pattern of storage could vary with each pharmacy experience usual practiceroutine of staff and the person-in charge and also depending on space av ailable turnover etc (i) The medicines could be stored c o m p a n y w i s e ie the medicines manufactured by one company should be grouped together and kept in one place Within each company shelfshelves the medicines may be placed in alphabetical order for easy and quick placement and removal Also bottles tubes boxes etc may be segregated within that shelf

38

(ii) The medicines may also be stored in a lphabe t ic al o r de r ie they are placed in order from left to right based on their name The first letter of the name is used to g r o u p t h e m e d i c i n e s t o g e t h e r a n d k e e p t h e m i n o n e l o c a t i o n I n s o m e p h a r m a c i e s a l l t h e strip packing are placed in drawers or boxes in alphabetical order each box or drawer containing strips of one particular alphabet This system ensures that the strips always remain e n c l o s e d i n t h e b o x e s d r a w e r s a n d a r e n o t e x p o s e d t o d u s t T h e d i s a d v a n t a g e i s that it might lead to mix -u p o f strips in the same drawer and it may cause a problem incase of similar looking strips in which case a wrong medicine may be dispensed Secondly cut strips lying around in the drawer may lose their identity if the batch n u m b e r andor expiry date is not seen on the cut portion of the strip

39

(iii) The medicines may be stored according to their therapeutic class ( e g a n t i b i o t i c s anti asthmatics or anti hypertensives) ie the medicines are kept together based on their pharmacological or therapeutic action

(iv) The medicines may be stockedsegregated according to dosage forms eg l i q u i d s (bottles) solid oral dosage forms eye drops rotacaps ointments etc all stored on separate shelves

Always Remember I Storage of prescription medicines should preferably be separate from OTC medicines OTC medicines especially those that a r e a d v e r t i s e d m a y b e d i s p l a y e d f o r c l i e n t s t o select or to ask questions about [OTC-O v e r t h e c o u n t e r ] II Storage according to temperatures is a must no matter which pattern of storage is followed Also within a particular storage area segregated storage may be maintained In a refrigerator for example medicines may be stored in trays racks and the freezer according to the temperature required

40

Whatever pattern of storage is selected all the personnel should ensure that middot The stocks are stored in an orderly manner middot The medicines are kept back in the same place from where they were removed middot All medicines are arranged neatly once in a while

middot The personnel should be careful while storing the medicines middot They should not throw the medicines haphazardly 23 Different means of storage

middot Within each temperature and security zone medicines must be stored so that they are easily accessible and protected against damage

middot Basic means of storage include shelves racks and drawers middot To prevent dust from entering the shelvesracks it is ideal to have glass

shutterssliding glass doors This can however be disadvantageous because accessibilityspeed is hampered in removing a product from the shelf because the glassshuttersliding glass has to be

41

opened m o v e d e v e r y t i m e a p r o d u c t h a s t o b e p i c k e d u p U s e o f a i r c o n d i t i o n e r s f o r t h e p h arm acy with a closed door at the e n t r a n c e o r a n a i r c u r t a i n c a n r e d u c e t h e d u s t problem In such cases the shelvesracks may be left o p e n

bull

middot Direct storage of cartons on the floor should be avoided because besides being an unhealthy practice the contents may also be damaged by moisture bull

middot Store medicines preferably in shelves with glass shutters for visibility middot Closed shelves further prevent dust from going in especially in India where most

pharmacies are located along busy roads middot Some medicines have to be refrigerated or stored in a cool or cold place Having a

refrigerator or two (as per the need of the pharmacy) is essential to store suc h medicines at temperatures mentioned on the label bull

42

Refrigeration middot All cold chain equipment should meet required standards middot Improvement in refrigeration technology has provided frost -free refrigerators

Pharmacists should opt for frost-free refrigerators as they are easy to maintain and protect printed packaging materials Conventional refrigerators may cause water falling from trays below the freezer on medicines stored in the refrigerator thus causing soggy labels

middot bull Frost-free refrigerators also provide separate and large compartments for the freezer portion (required for storing medicines needing sub-z e r o t e m p e r a t u r e ) and the main storage area with separate doors so that opening one door does not disturb the storage temperature in the other compartment

Care should be taken to keep the refrigerator on 24 hours a day It should not be switched off after working hours It is advisable to have an inverter connected to the refrigerator so that the refrigerator re mains working even when there is a power outage

middot The refrigerator door should be closed tightly middot The refrigerator door should not be left open for too long middot Space should be left between medicines stored in a refrigerator to allow air to

circulate middot The ref rigerator should be placed about an arms length away from the wall

This will increase air circulation thus not affecting the cooling within the refrigerator

middot Vaccines should not be stored on refrigerator door shelves as they are exposed to warmer temperatures each time the door is opened Vaccines should always be stored on the middle shelves of the refrigerator

middot Refrigerated medicines should not be left out of the refrigerator for more than a few minutes

43

middot Consumable products like juices energy drinks e t c s h o u l d n o t b e s t o r e d a l o n g with medicines in refrigerators If required they may be kept in a separate refrigerator

middot An adequate number of refrigerators should be planned to store the entire stocks requiring refrigerated storage

middot Adequate procedures should be followed for defrosting cleaning and maintenance of refrigerators

middot Icefreeze packs should be kept in the freezer compartment so that they can be used for transporting cold temperature medicines The packs can be given to clients along with the medicines requiring cold temperature storage so that the temperature is maintained till the client reaches home and can then put the medicines in a refrigerator) Freezer packs can also be used to keep medicines temporarily in case there is a power outage or refrigerator breakdown

Activity

Prepare a SOP (Standard operating procedure chart) for cleaning a refrigerator Discuss it with your staff finalize its maintenance once a month through AMC -A n n u a l Maintenance contract CMC - Comprehensive maintenance contract and put it up on the pharmacy refrigerator Put the Purchase Order details name of manufacturer Phone of Service Engineer and a register to login the Machine service and down timeService reports may be maintained properly

Refrigerator monitoring and maintenance

middot bullIt is important to carry out routine monitoring and maintenance of the refrigerators and to organize an effective repair system

middot bullThe temperature in the refrigerator must be monitored and recorded routinely at least once a day

middot Any breakdown must be reco rded including the period during which the medicines were exposed to uncontrolled temperatures Medicines may then be kept or discarded depending on the problem guidelines or the manufacturers advice

middot Cold chain monitor cards and devices in or on packages that change color or otherwise alert staff to potential damage assist in monitoring (These are likely to be introduced in India soon)

middot It is essential to have a contingency plan in place before a refrigerator breaks down An arrangement can be made to move the contents to a private refrigerator elsewhere in the community or to obtain a regular supply of ice packs until the defect is rectified

Put filled water bottles in the bottom half of the refrigerator door in order to provide cooling in the refri g e r a t o r w h e n t h e r e i s a p o w e r o u t a g e T h i s m i g h t t a k e c a r e o f t h e temperature when there is no current for a couple of hours If the power outage is expected to last for several hours special arrangements such as an inverter UPS have to be made to keep the refrigerator constantly running in the absence of electricity middot Defrost the refrigerator in case of excessive ice formation and preferably at regular

intervals Keep a record of the same

44

2 4 T e m p e r a t u r e c l i m a t i c c o n d i t i o n s

i) Temperature control middot The medicines in a pharmacy need to be stored at appropriate temperatures to

maintain their stability middot An air-conditioned environment where temperature can be controlled is

recommended for pharmacies Air conditioning offers the option of setting the t e m p e rature as per requirements

middot bullIt is ideal to have an air conditioner to maintain the temperature below 25 C as most medicines require storage below this temperature Secondly this temperature is pleasing to both the staff and the visiting customers too

middot In the absence of an air conditioner circulating fans may be used middot This need is felt even more in certain parts of India where temperatures soar above 45

C and some areas where it falls to sub zero temperatures In such cases temperature maintenance is essential to prevent deterioration of medicines due to unnecessary exposure to drastic temperature fluctuations

middot This need is felt even more in certain parts of India where temperatures soar above 45 C and some areas where it falls to sub zero temperat u r e s I n s u c h c a s e s temperature maintenance is essential to prevent deterioration of medicines due to unnecessary exposure to drastic temperature fluctuations

i i ) Humidity or moisture control Moisture or humidity can adversely affect the stability of me dicines such as tablets capsules powders

45

Gelatin capsules become soft and swell on absorption of moisture The drug content of tablets may undergo surface hydrolysis The presence of moisture may encourage the growth of microbes It is therefore essential to control humidity

To reduce the effect of humidity the following suggestions may be followed -middot Open the windows to allow air circulation Use a fan to circulate fresh (outside) air middot In humid climate a dehumidifier is useful for preventing mo i s t u r e d a m a g e ( i n t h e absence of an air conditioner) middot For bulk containers of tabletscapsules do not keep the container open for a long time and replace the lid or closure immediately after taking out the required number of medicines for dispensing middot Do not allow the medicines to touch the floor or the walls The walls may be damp and may cause moisture absorption damaging the product

middot Calibrated thermometers and manometers can be used to detect temperature and humidity in the pharmacy

middot Periodici t y of checking the temperature should be fixed middot The climatic conditions should be recorded and documented middot Temperature charts should be available for ready reference

Documentation is one of the core activities for achieving and maintaining quality It is one of the most essential components of validation Temperatures in various areas

46

including refrigerators should be recorded at a predetermined periodicity usually daily at the hottest time of the day and such documents should be preserved i i i ) Storage conditions A number of storage conditions are mentioned on the labels of medicinal products These conditions have to be properly interpreted and appropriately complied with

According to the Drugs and Cosmetics Rules 1945

1 The term cool place means a place having a temperature between 10 C and 25 C

2 The term cold place means a place having a temperature not exceeding 8 C In case of storage conditions for specific products please refer to Schedule P The Drugs and Cosmetic Rules 1 9 4 5

The Indian Pharmacopoeia specifies the following storage conditions -

Wherever the condition for storage is not specified medicines may be stored under normal temperature In a country like India however where normal temperatures soar to h i gh temperatures it is recommended that medicines be stored in a cool place

Activity Prepare a list of the storage requirements mentioned on the label of about 20 products in your pharmacy and check if the temperature is maintained

47

25 Special Storage o f s u p p l i e s If the product has no special instructions normal storage conditions apply This means storage in dry clean w e l l -ventilated premises at temperatures of +15 C to +25 C or depending on the climate up to +30 C (WHO1990) Storage instructions are product specific Different brands of the same generic drug may have different storage requirements as they may have different packaging or formulations It is essential to follow the product manufacturers storage instructions to the maximum extent possible Less stable medicines must be stored in specific conditions to maintain their quality or potency

The following products require special storage facilities

middot Products that must be kept frozen (usually vaccines and sera) middot Products sensitive to h eat an d r e q uir in g r e f r ig e r a tio n ( +2 C to +8 C) middot Products that have reduced shelf life at uncontrolled room temperature and need

mechanical ventilation or air conditioning middot Flammable products that require separate fireproof premises middot Products prone to theft o r m i s u s e

Products needing storage in a controlled environment -

The usable shelf life of the following products may be reduced if stored at uncontrolled humidity or at room temperature in hot climates -

middot Some injectables (eg adrenaline) Most injectable preparations are less stable than solid oral forms (tablets and capsules) Injectable preparations in solution are particularly unstable Many injections must be protected from light as well as heat

middot Intravenous fluids (particularly if packed in p lastic containers) middot Some suppositories pessaries creams and ointments These products may melt at

temperatures greater than 30 C Once this happens it is not advisable to use them because the active ingredient in the formula may get unevenly distributed

middot Products containing rubber latex cellulose or some plastics Condoms most sterile disposable medical devices and surgical products such as syringes needles and catheters require protection from excessive humidity and strong light and heat Any o f these conditions may make products brittle stained amp unusable Sterility cannot be assumed if packaging is damaged

In hot climates these products should be stored in the coolest place possible preferably with air conditioning or air circulation fans

48

Products needing freezing or refrigeration-middot Vaccines blood products and many other medicines lose potency if kept even for a

brief period at temperatures outside the recommended range For these products the cold chain must be maintained at every stage of the distribution system

middot Freezing is as damaging as high temperatures for some products including injectable contraceptives ergometrine insulin adrenaline and the DPT DT TT and Hepatitis B vaccines Such products therefore sho uld not be allowed to freeze (not be kept in the freezer compartment)

middot Short periods at room temperature (during transportation or local distribution for instance) may be acceptable for many products (such as ergometrine a n d i n s u l i n ) e v e n t h o u g h s u c h e x posure can to some extent reduce shelf life Other items such as vaccines should always be transported in cold boxes

Storage of insulin injections-

middot Insulin should always be stored in a refrigerator at the recommended temperature of 2 -8 C

middot Insulin should not be kept in the freezer compartment of the refrigerator middot Insulin should ideally be stored horizontally middot It should not be exposed to sunlight or excessive heat middot Insulin suspensions should not be used if the suspension cannot be properly

resuspended due to cake or clump formationbull

Controlled drugs -Narcotics (for example Pethidine injection morphine preparations) and other specified drugs that may be abused are governed by special legislation and regulations The following security measures are suggested in the pharmacy -middot A safe or reinforced double locked cabinet fitted with a light (preferably with a red

bulb) that comes on when the door is opened

49

middot A special register recording details of each receipt or issue with 2 signatures physi cal counting of medicines after each entry and signatures at handover takeover

middot Independent audit (by supervisors and drug inspectors)

Products prone to theft abuse or misuse -

Some medicinesproducts are particularly prone to theft abuse or misuse These include expensive medicines (eg insulin) certain antibiotics and products prone to abuse or misuse like psychotropics etc

Such medicinesproducts should be stored adequately They require stricter record keeping and more frequent stock taki ng than others Periodic audits should be carried out to check for consumption against actual recorded use (registers prescription records stock records etc) to expose any theft or misuse bull26 Storage and stability of medicines Medicines are not stab le indefinitely They are stable for a specific period of time sometimes for a brief period Poor storage conditions accelerate the drug degradation (decomposition) Temperature light and moisture are the most important contributing factors for drug instability It is important to identify and be aware of the potential for instability There is a need to comply with storage requirements to ensure quality medicines for patients It is also important to offer advice to patients too about appropriate storage o f medicines at home The dispensing label should state the storage condition required and be backed up by a verbal reminder especially where special storage is required bull

50

In case stability and storage problems are seen with formulations they should be reported immediately to the representative of the manufacturer and taken out of circulation till the stability problems have been resolved

The pharmacist can easily detect stability problems when products show change in appearance color odor settling of the product contents breaking of emulsions melting of creams oozing of contents from the containers and any such physical changes

3 STOCK CONTROL AND EXPIRY MONITORING 3 1 S t o c k C o n t r o l For economic reasons pharmacists do not like to have stock on their shelves for long periods of time The aim should always be to keep stock at a level that will just meet demand Normally most manufactured medicines have a long shelf life Even then it is essential that there is efficient stock rot ation so that the older stock is used first It is also a good practice to check the expiry date as an integral part of the dispensing process When short shelf life products are involved stock levels may have to be modified to prevent medicines regularl y expiring on the shelves

32 Stock rotation and expiry monitoring In order to avoid accumulation of expired and obsolete stock medicines should be stored and issued according to the following guidelines -middot The stock control system must record the ex p i r y d a t e a n d t h e d a t e o f r e c e i p t middot Stock must be stored so that earliest expiring batches are picked and issued first middot The First In First Out (FIFO) system - In this system the stock which is received

first is sold first This system however may not be useful for pharmacies because most of the stocks carry an expiry date For pharmacies the FEFO system is more practical

51

middot The First Expiry First Out (FEFO) system - In this system the stock having an earlier expiry is sold first The stock with longer shelf life should be placed farthest to the back (or at the bottom in case o f sta c k e d b oxe s) T h is is pa r tic u la r ly impor ta n t with products that have short shelf lives such as vaccines some vitamins antibiotics etc and reduces losses due to expiry

middot E x p i r y dates should be noted on the stock record upon receipt Stock nearing expiry should not be accepted unless it can be used before expiry

Computerization and expiry monitoring In the pharmacy computerization facilitates both checking stocks and expiry mo nitoring and helps-bullbullKeeping a check on products nearing expiry bullbullKeeping a check on non- moving and slow moving products bullbullTo facilitate the removal of medicines nearing expiry from shelves in time to send them back to the wholesaler or supplier

Periodic checking for expiry The expiry date for medicinal products is a critical aspect in pharmaceutical dispensing and due importance should be given to it Periodic checking for expiry of medicines will ensure that the patient will never receive products that have crossed their expiry date During periodical checking of expiry the personnel involved should remove medicines that are nearing expiry bullbullIn -house threshold periods should be set and followed for retrieval of such medicines from the shelves bullbullSuch medicines should be stored separately These should either be dispensed immediately (thus ensuring that they are used before the expiry date) o r t h e y s h o u l d b e returned to the suppliers bullbullA separate area should be designated (cupboard or shelf)marked[FROZEN ZONE] which is adequately marked EXPIRED GOODS- NOT FOR SALE to store all expired stocks FROZEN ZONE

52

Remember Expired medicines are a NATIONAL WASTE So stock only what you can sell Avoid expiries save precious medicines for the nation

Treatment and disposing of expired medicines bullbullProcedures need to be in place for the treatment of expired medicines bullbullThe expired medicines need to be collected and be sent back to the supplier or company for appropriate disposal bullbullRecords must be maintained for expired medicines and how they are disposed off bullbullIn case of medicines that are not returnable to suppliers procedures for disposal need to be followed by the pharmacy in conjunction with the FDA The following procedure can be followed if medicines cannot be returned to suppliers ( T h e b a s i c p h i l o s o p h y of appropriate disposal is to prevent their re- circulation and use) bullbullC u t t h e c o n t ainer in such a manner that the label is also cut In case of tablets and c a p s u l e s d e s t r o y them by disposing them in a bucket of water bullbullUse landfill procedures (deep burial into the ground as per stipulations of Medical Waste Disposal Act prevalent in the respective state) bullbullPour the liquids into the sink and wash away with sufficient quantity of water bullbullKeep a record of such disposal with full details of medicines destroyed Although these measures are usually adopted care has to be taken with such tr e a t m e n t a s studies have shown that flushing of medicines has resulted in tracessmall quantities of medicines being found in waterways and groundwater having potential health and environmental effects

4 O T H E R A S P E C T S 41 Design of storage areas The following important factors need to be considered in design of storage areas -middot The retail outlets in hot areas in summers should be air-conditioned Similarly in

a r e a s o f e x t r e m e c o l d t h e p r e m i s e s w o u l d r e q u i r e w a r m i n g e s p e c i a l l y i n w i n t e r s t o maintain cool temperatures The placement of air -conditioners and heating devices should be such that medicines are not directly exposed to the cold or heat

middot Due consideration should be given to storage requirements of formulations while designing shelves and cupboards in retail outlets Sufficient shelf height should be provided so that all liquid products can be stored vertically As far as possible the shelves should be covered with glass panels to protect medicines from dust and p r e v e n t r a p i d f l u c t u a t i o n s i n temperature

middot Medicines should be stored according to the storage instructions on the labels bullIt is ideal to have a door at the pharmacy entrance to prevent dust from coming in as well as reduceprevent cooled air from going out This may not however be considered feasiblepracticable by many pharmacy owners for fear that clients may not enter the pharmacy because the door may act as a barrier An air curtain is a good alternative to a door

middot There should be minimal direct sunlight falling on the products Particular consideration should be given to premises directly facing the sun

middot bullThe arrangement of lighting in the interior of the premises should also be in a manner that the lights are not focused on the products It has been shown that light causes not only chemical damage but also can catalyze physical changes like moisture uptak e by the products Care should be taken to ensure that only diffused light falls on them

53

middot As far as possible provision should be made for a temperature and humidity indicator device in a pharmacy These devices are now easily available

middot Stability studies o f m e d i c i n e s p a c k e d i n b l i s t e r s h a v e r e v e a l e d t h a t i f t h e s e a r e exposed to light they tend to absorb moisture It is therefore necessary to store them in suitable cartons so that the blisters are not exposed to light Pharmacists should do this even if the manufacturer has not provided cartons

middot Light and temperature sensitive products should not be stored on counters where the light is intense or direct and there is no protection from temperature and humidity

42 Cleaning and maintenance i) Cleaning of storage areas

The storage areas of the pharmacy should be cleaned periodically and cleanliness should be maintained at all times The Standard Operating Procedure for cleaning should be designed and followed accordingly Schedules for cleanups should be laid down and adequate cleaning equipment should be made available

Tips for maintaining cleanliness middot Provide clean pieces of cloth for wiping at various locations in the pharmacy

Replace with clean cloth at regular intervals middot Keep separate pieces of cloth for floors shelves and medicines middot Use a disinfectant andor soap solution to clean floors middot Ensure removal of dust and prevent accumulation of dirt middot Ensure removal of cobwebs middot Use a vacuum cleaner for cleaning areas not easily reachable middot T a k e c a r e t h at breakages are handled and cleared effectively middot Observe the factors leading to waste generation in the pharmacy and take appropriate

measures to tackle the problem middot Record all cleaning procedures performed and maintain all the documents required

For ex a m p l e -bullbullThe floor of the pharmacy may be swept with a broom and swabbed with soap water every morning bullbullThe floor may be swabbed with a disinfectant every week bullbullThe entire premises including shelves and cupboards may be cleaned with a cloth (to remove dust and to check for medicines approaching expiry date or expired medicines) every three months bullbullAll the steps followed should be r e c o r d e d

The floor shelves drawers have to be cleaned and a check should be kept on dust cobwebs spillages due to breakage etc It is therefore essential to have SOPs for cleaning laying down cleaning frequencies allotting responsibilities and maintaining a daily record in the logbook to document all these activities

54

While cleaning dust settled on dosage forms like bottles tubes etc should be removed Before dispensing the products should also be wiped to remove any dust settled during storage

For refrigerators bullbullDefrosting and cleaning should be done at regular intervals bullbullSwitch off the refrigerator while cleaning bullbullCleaning should be done quickly and stocks put back immediately

i i ) Pest control Pests are a serious problem in India where insects reptiles and rodents (eg cockroaches l i z a r d s r a t s s i l v e r f i s h (Deemak - in Hindi ) etc) may find access to the pharmacy storage areas Insects like ants and borer ants may often attack wood in the pharmacy causing d am ag e to shelves cupboardsPest c ontr o l in a p h a r m a c y c a n b e a d i f f i c u l t t a s k b u t t o avoid possible contamination and physical damage to stock it is necessary to keep pests out of the pharmacy premisesPest control measures should be implemented with proper p r e c a u t i o n s t a k i n g u t m o s t c a r e t o a v o i d contamination of medicines

55

Th e following pest control measures c a n be ta ke n f r om tim e to tim e -bullbullRat bait and traps can be placed at various locations bullbullInsecticutors can be used on a permanent basis bullbullInsecticidal sprays and repellants can be used from time to time

i i i ) Fire precautions

Combustible trash such as cartons boxes and other packing waste must not be allowed to accumulate in the store Waste should be deposited in appropriate waste bins and be d i s p o s e d o f f o n a d a i l y b a s i s

F i re detection and fire fighting equipment must be maintained and regularly inspected The pharmacy personnel should receive adequate training in fire fighting techniques and emergency actionFire prevention measures should include a prominently displayed ldquoNoSmokingrdquo sign careful handling and disposal of combustible waste materials and checking of electrical connections at regular intervals

iv) Security middot Doors shutters of the pharmacy should be strong and be fitted with secure locks middot Counters should be designed so that unauthorized personnelclients do not have

access to areas where prescription medicines are stored Access to such areas should be restricted to the pharmacy staff

middot All the pharmacy staff handling supplies should be accountable for their ac t i o n s

56

middot bullSpecial care must be taken in case of Schedule X and manufactured drugs (under NDPS Act) Such medicines should be kept under lock and key and the key should be kept with the Chief Pharmacist or i n h i s a b s e n c e t h e s e n i o r p h a r m a c i s t

v) Breakagespillage and damaged product Products that have been damagedspoiled during storage and handling spillages and broken glassware should be disposed off according to procedures laid down by the pharmacy Broken and damaged products s h o u l d b e p l a c e d i n a segregated area to be returned to the supplier

vi) Inspection Senior staff should inspect all pharmacy areas regularly The shelves and drawers should b e c h e c k e d d a i l y f o r signs of pests and dust Ceiling and walls should be checked for dirt and cobwebs Stock should be checked on a regular basis for deterioration due to climatic conditions

43 Product recalls Products found to be defective should be quickly recalled (withdrawn from the market) The instructions are generally issued either by the manufacturer or the regulatory agency The level of recall is determined by both the degree of risk and the extent of distribution of the product and in India is mainly directed at the distribution chain

On receiving the details of the defective substandard spurious batchbatches of a medicine to be recalled from the manufacturer or the stockist or the FDA the pharmacy should immediately check if the particular b a t c h i s i n s t o c k a n d i f s o s u s p e n d i t s s a l e immediately

Similarly if the regulatory authority in the country bans a particular medicine or FDC the pharmacy should immediately check and remove all the different brands of that particular medicine under consideration

The details of medicines and their batches to be recalled should be available in the q u a r a n t i n e a r e a w h e r e stocks are received and checked This is to ensure that such medicines do not come into the pharmacy

middot The pharmacy should develop SOPs for recall of medicines middot The pharmacy staff should be immediately informed about such medicines and

the details should be displayed in writing in a prominent place in the pharmacy middot Rapid action helps avoid unnecessary exposure to such medicines once the

problem has been d e t e c t e d middot The progress of the recall procedure in the pharmacy should be monitored every

few days to ensure complete compliance middot All stocks of the recalled products should be stored separately from the saleable

stock These can be stored in the expiry cupboard segregated from the expired goods and be appropriately labeled ldquoRecal l e d G o o d s - Not for Salerdquo

The supplier should be notified and asked to replace defective products middot All the details of the procedures followed should be duly recorded in a Recall

Register maintained specially for the purpose The register should include d etails such as -middot Date of the recall middot Nam e of the product

57

bullbull

middot Details of the product (name of manufacturer batch number expiry date) middot Nu m b er of units purchased sold a n d sto c k in ha nd middot Reason for recall middot Nam e of the supplier to whom produc ts w e r e returned along with the date and quantity middot Name and signature of the designated personnel carrying out the recall procedure and recording details middot Name and signature of the chief pharmacist verifying the recall procedures and recording details 4 4 Returned medicines

Medicines may be returned to the pharmacy by clients due to the following reasons -bull

bullbull Unused medicines bullbull Course not completed bullbull Therapy changed by doctor bullbull Side effects experienced by patient bull

bullbull DamagedDefective medicines bullbull Missing or defaced label bullbull Missing tablets in a stripblister bullbull Leakage in bottles bullbull Leakage in strips bull

bullbull Expired medicines

Appropriate SOPs should be framed and followed for their acceptancerefusal and disposal middot bull For unused medicines returned by clients the p harmacy personnel should verify

that these were purchased from their pharmacy They should then be checked for integrity of the packing the dosage form and the expiry date and verified with the client whether they were stored in appropriate conditions This again is at the discretion of each pharmacy

middot The damageddefective medicines returned to the pharmacy should be taken back and stored separately Existing stock of the same product should be checked for similar defects

middot Expired medicines should be accepted from clients at the discretion of the pharmacist and be immediately shifted to the expired goods cupboard These can be stored segregated from the pharmacys own expired goods and be appropriately labelled ldquoExpired Goods returned by clients- Not For Salerdquo

It is advisable not to accept returned medicines requiring cold chain storage (refrigeration) because it cannot be ensured that the cold chain was maintained when the medicines were in the hands of the patientclient middot Appropriate adjustments in t he stocks should be made for medicines

returnedexchanged to update the inventory middot The medicines should then be returned to the respective shelves middot A lsquoReturned Goodsrsquo register needs to be maintained to record all details of returned

medicines

R egister should include such details as-

58

middot N a m e o f t h e p a t i e n t middot Nam e of the product and quantity r e tu r n e d middot Product details such as the batch number and expiry date middot Condition in which received middot Reason for returning products middot Compensatory measures taken wi t h r e s p e c t t o c l i e n t middot Action taken with respect to product middot Name and signature of the personnel accepting the returned medicines and recording details middot Name and signature of the chief pharmacist verifying the recorded details

What the pharmacist would have learnt from this module The storage of medicines is a critical factor in the distribution cycle bullbull Stocks received by the pharmacy should be quarantined in a separate area and necessary checks s h o u ld be performed to ascertain the qua lity a nd quantity of stocks received bullbull Whatever pattern and means of storage used the products should be stored so as to maintain their potency and integrity bullbull Storage conditions should be monitored and maintained on a regular basis bullbull Optimum stock levels should be maintained and regularly monitored for expiry bullbull The design of storage areas should facilitate appropriate storage of medicines bullbull Cleanliness should be maintained in the pharmacy bullbull Adequate measures should be taken in case of returned medicines and recalled products

Optimum storage of medicines is mandatory whether at the distribution stage at the pharmacy or ultimately within the homes of patients The pharmacist has an important r o l e t o p l a y i n t h e s t o r a g e o f m e d i c i n e s i n m a i n t a i n i n g d r u g p o t ency and efficacy and thus facilitating optimum therapeutic benefits Good Pharmacy Practice - IPA -CDSCO - WHO Appendix I Quality Assurance Templates of letters for use if found not of Standard Quality [Frozen and expired goods ]

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated To Name of the Supplier with address

Sub Not of Standard Quality GoMP-Supply of Drugs and medicines-(Codename) Return of Stocks to the Suppliers-reg(New drug policy 2009) Previous letterinvoice ref Sl No Drug Code Drug name

Manufacturing date Expiry date

Supplier address

B a t c h n o

The above items of PO nodated was drawn by the Drug Inspector (Place) on (______________date) as a statutory sampling and declared ldquoNot of Standard

59

Qualityrdquo on -(______________date) by the Government Analyst for the following reasons

- ldquoThe product sample do not confirm to IP specification for (Drug codename with respect to the content of drugrdquo

- ldquoThe product has already been blacklisted by TNMSC on -(______________date) for the failure of (quantity) of batches of drug codenamerdquo

As per the clause of the te nde r d oc um e nt ldquo I f the sa mple s d o not c onf o r m to statutory standardsthe tenderer will be liable for relevant action under the existing laws and the entire stock in such batch should be taken back by the tenderer within a period of 30 days o f t h e r e c e i p t o f t h e l e t t e r f r o m t h e v e n u e

The stock shall be taken back at the expenses of the tendererthe Procurement Authority have the right to destroy such Not of Standard Quality if the tenderer does not take back the goods within the stipulated time

The Procuring Authority will arrange to destroy the Not of Standard Quality drugs within 90 days after the expiry of 30 days mentioned above without further notice and shall also collect demurrage charges calculated at the rate of 2 per week on the value of the drugs rejected till such destructionrdquo

Hence we regret to inform you that you will have to take back the stocks available of the abovesaid batch at your own cost from the drug stores where you have supplied the above batch

Kindly acknowledge the receipt of this reference at once

P r o c u r e m e n t A u t h o r i t y Seal and Stamp

Copy to Ref No dated

1 ) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated13082010

To

Sub Frozen Drugs-ordered to return to the Suppliers-reg(New drug policy 2009) Previous letterinvoice ref

The following products which were earlier frozen have now been ordered to return to suppliers directly with permission from the State drug Authority In this regard the suppliers have been instructed to take back their failed batch from the drug store of the stores Hence you are now instructed to return the following failed batches to the suppliers by obtaining proper authorization letter and acknowledgements from them

60

Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

Kindly acknowledge the receipt of this reference at once

Procurement Authority Seal and Stamp

Copy to

Ref No dated 2) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated14092010

To

Sub Frozen Drugs-ordered to return to the Suppliers- for issue of gate pass after verification reg(New drug policy 2009) Previous letterinvoice ref

The following products which were earlier frozen have now been released Hence they may be issued Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

Kindly acknowledge the receipt of this reference at once

Procurement Authority Seal and Stamp

Copy to

61

Ref No dated 3) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated

To

Sub Stop instruction-reg(New drug policy 2009) Previous letterinvoice ref

Until further instructions stop issue all the batches of the following item Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

You must intimate the available stock in the stores of the said batch Number to the Procurement Authority immediately Also retrieve quantity if already issued

Procurement Authority Seal and Stamp

Copy to

Ref No dated 4) HOD Procurement Office of

62

Appendix II Material handling in drug stores

Rack approx rates and dimensions

S No

Item Description UOM Approx Rate

1 MEDIUM DUTY RACK SIZE 2900 H X 3090 W X 800 D IN MM (AS PER SPECIFICATION)

Each 2499800

2 MEDIUM DUTY RACK ADD ON UNIT FOR SIZE OF SR NO2

Each 2243100

To locate a Box no 3 Rack no 14 in row3

SAMPLE OF RACK no Bin numbering -------------- S a y R K 1 4 R o w 3 B o x 1 6

SAMPLE LAYOUT of RACKS in a Drug Stores

63

Sample of another warehouse of distribution warehouse system

64

65

Slotted Angle racks with bin cards

66

Plastic Pallets

Plastic pallets ar e l i g h t w e i g h t l o w- c ost and exceed industry standards for strength and durability

NOTE A pallet has bottom deckboards (see sketch) A skid does not have bottom

67

deckboards

Battery Operated Stacker

Electric Stacker Ehh (Manual Push Type) - Manual drive - Lifting electrically with Battery 12 V 88 Ah - For loading and un-loading of trucks - Battery and loading device built - in - Battery charge gauge and charging current gauge Simple and Easy Operation - Lifting and Lowering electrically direct on steering arm - Pulling and pushing through steering arm - Electrically operated relief valve on hydraulic aggregate Safe Operation - Emergency Off Switch - Constant lowering speed - Protection through lowering brake valve - Overload protection through overload brake valve - Load chains covered preventing pinching threat - Electrically interlocking during loading process - Secured battery compartment opens upwardly - Stable buffering of the steering arm in upright position - In accordance with EWG Guidelines 89 240 - In accordance with VBG 12b Prevention of Accidents

Pallet Truck [ Top ]

68

----------------------------------------------------------------------------------------------------------------------------

For Transport Of All Goods On Pallets Safe and Easy Operation - through single hand operation Lifting moving

lowering with steering handle - neutral position of the hydraulic possible - overload pressure relief valve Long Service Life - robust co n s t r u c t i o n

- special hardened axles - hardened chromium plated ram - maintenance free Easy Maneuverability - through rubber steering rollers - nylon fork rollers

A h a n d t r o l l e y

69

Trolley with plastic bins for several items del ivery

70

Digital Weighing balances

Balances amp Scales EF Seriers Precision Electronic Balance

71

1

Ice lined Refrigerators

600 litres refrigrator

72

Walk in cooler

vacuum cleaner

73

ACQUISITION OF STORES

The word Stores used hereunder applies generally to all articles expendable as well as dead stock of the nature of plant machinery instruments furniture fixtures medicines linen etc etc

Any authority which is competent to incur contingent expenditure may sanction the purchase of stores required (sub ject to his d e le ga tion of f ina nc ia l pow e r s) pr o vide d the following rules are observed-

(a) A Purchase Committee comprising of atleast three Gazetted Officers is formed for approving quantity and quality of stores required

( b ) An enquiry for the articles purch ased should be sent out to various manufacturers and dealers if the total of the order is for Rs 15000 or less In case the purchase order is likely to exceed Rs 15000 ldquoopen tendersrdquo be called through news paper publicity ( f igur e s p e r ta in to 1 977)

(c) Stores s h o u l d n o t b e p u r c h a s e d i n s m a l l q u a n t i t i e s and often if such store is not perishable

( d ) Requirement of the whole year to be worked out a nd n o stor e sh ould b e p ur c h a se d in e x c e ss o f the requirement

(e) P u r c h a s e s h o u l d b e m a d e i n t h e m o s t e c o n o m i c a l manner but q ua lity ne e d not be sa c r if ic e d in the interest of the economy

(f) The details regarding the quality desired and expected purchase quantity should be mentioned in t h e e n q u i r y

(g) Purchase order should not be split up to avoid the ne c e ssity o f obta ining th e sa nc tio n o f t h e h i g h e r authority

( h ) The date and time of opening of the tender should also be published and in case the tenderers desire to be p r e se nt o n th e o c c a sio n th e y should b e a llo w e d t o d o s o

( i ) Mere initialing on the covers of the tenders is not sufficient All the Purchase committee members s h o u l d s i g n o n e a c h a n d e v e r y p a g e o f t e n d e r q u o t i n g t h e r a t e s A n y r a t e s w h i c h h a v e b e e n overwritten by the tenderer should not be c o n s i d e r e d u n l e s s t h e y b e a r t h e t e n d e r e r rsquo s s i g n a t u r e and subsequently signed by a member o f t h e Purchase committee

( j ) A list of tenders opened should be made out and t a l l i e d w i t h t h e o n e o f t h o s e r e c e i v e d i n t h e o f f i c e Such a list should be signed by all the members of the Purchase committee

( k ) A comparative statement is then made and lowest t e n d er i s a c c e p t e d s u b j e c t t o q u a l i t y o f f e r e d b e i n g

10

satisfactory Samples of non perishable articles should be preserved safely under lock and key for comparison till the contract for supply is in force

( l ) R e a s o n s for rejecting the lowest tender and accepting the h i g h e r o n e s h o u l d a l w a y s b e r e c o r d e d in writing by the Purchase Committee

(m) No reason for rejecting the lowest tender need to be communicated to the tenderer

( n ) Every purchase order should clearly mention that the articles ordered shall be accepted subject to t h e approval of the Purchase Committee

( o ) Rules regarding deposition of earnest money and security money should be observed

( p ) For emergent purchases in public interest when there is no time to observe Store Purchase Rules purchases should be made up to Rs 2 5000 (refers to year -1 9 7 7 ) a t a t i m e A s f a r a s p o s s i b l e t h i s practice should be avoided

II PLACING OF ORDERS (a) For medicines and such other articles which the Medical Stores Depot Bombay

supplies order be placed with them at a specified time ( b ) For articles not on the Bombay Stores Depot Bombay lsquolimitedrsquo or lsquoopenrsquo

tenders be invited as the case may require It would be preferable to place orders on the manufactures or their authorized distributors

(c) For placing the orders on PSUrsquos Laghu Udyog Nigam or Organisations approved by the State government no tender needs to be invited

( d ) Price preference upto 10 is available to Small Scale Industries of this State only(not applicable as per New drug policy 2010 -1 1 )

III RECEIPT OF STORES All materials received should be examined counted measured or weighed as the

case may be when the delivery is taken The stores thus verified be may be immediately entered in the stock register Book under proper headings and this fact should be recorded on the body of the bill mentioning the page number of the Stock Book It should also be mentioned whether the quality and the quantity are correct as per the requirement Soon after the receipt each item be stamped with the initials of the institution

IV CUSTODY

(a)The head of the institution should ensure suitable accommodation for keeping the stores with a view to prevent losses through theft accident fraud or otherwise

(b) Separate Stock Accounts should be kept of-( i ) D e a d S t o c k-such as plantmachineryfurniture equipmentinstruments

etc (ii) Expendible items such as medicineslinenrubber goods etc (iii) Perishable articles

(c ) all recepts and issues in the stores stock registers should be on the authorityand under the signature of a respon sible officer deputed for the purpose

11

V ISSUE OF STORES (a) When materials are issued from stock the officer -i n ndashcharge should ensure that the indent is in proper proforma (Annexure A) and the person taking delivery is an authorized one (b) The issue vouchers (Annexure B) for articles should be prepared in triplicate by one single stroke of pen The first copy will remain with the records of the stores The second and third copies will go to supplies The second copy will be retained by the person receiving the supplies and the third copy will be returned by the receiver to the stores after making entries of hisher stock book page number etc against each item ( C ) E v e r y t i m e i s s u e b e r e c o r d e d i n t h e s t o c k b o o k o f t h e s t o r e s w i t h s i g n a t u r e s o f t h e O f f i ce r i n -charge

(d) Every issue made from the Central Stores to other institution should show cost of article preparation of Annual Stores Account at a later date

VI Maintenance of Stock Books (a) Stock book should be kept under the charge of a responsible person and should be

saved from loss and destruction ( b ) While making new entries in the main Stores Stock book cost of each item

should be entered though this need not be done in the case of registers in Wards Operation Theatre Out door etc

(c) There should b e n o o v e r-writing or interpolation or smudging of figures Any f i g u r e i f i t i s t o b e c o r r e c t e d s h o u l d b e c l e a n l y c u t a c r o s s a n d t h e n e w f i g u r e should be written by its side or below it under proper attestation

( d ) Stock books should always have a page count(each page be numbered) A certificate showing the number of pages be given on the first and the last page under the signatures of a Gazetted Officer

(e) Receipts issues and balances should be worked out for every item and attested regularly by the Offic er-i n -Charge of the Stores

(f) In the receipt column details regarding the size quality and any special features if t h e r e b e s h o u l d b e r e c o r d e d e g i n t h e c a s e o f A l m i r a h i t s s i z e a n d w h e t h e r i t i s of Steel or Wood

(g) In the Stock-book of library Edition and the ye a r o f p ublic a tion of th e book should always be mentioned

( h ) In case of medicines having an expiry date a list of such medicines be made out and should be checked every week Two months prior to the date of expiry if the s t o c k i s s t i l l f o u n d s u f f i c iently high intimation should be given to Directorate of Health

(i) N o r e m o v a l o f d e a d s t o c k s h o u l d b e m a d e f r o m t h e s t o c k ndash B o o k u n l e s s s o a u t h o r i z e d b y t h e c o m p e t e n t A u t h o r i t y

(j) While making a new Stock book and transferring the stocks therein it should ensured that the page number of the old stock book is shown in the new stock b o o k a n d s i m i l a r l y p a g e n u m b e r o f t h e n e w s t o c k b o o k i s m e n t i o n e d i n t h e o l d one This has to be done to facilitate cross checking whenever desired

( k ) T h e r e h a v e t o b e d i f f e r e n t s e t s o f proforma for dead stocks and for expendable items

Annexure ldquoCrdquo is for former and Annexure ldquoDrdquo for the latter varieties

12

VII PROCEDURE OF INDENTING FOR WARD amp OTHER SECTIONS OF THE INSTITUTION

(a) There has to be an Indent Book with every such section wh ich receives and issues medicinesequipment

( b ) The indent shall be prepared by the nurse Compounded -i n -c ha r g e of th e WardSection in te single copy on the Performa (Annexure A)

(c) The indent so prepared will be signed by the medical officer resident ndash i n c h arge or in his absence by a doctor senior to him but associated with the ward section

( d ) The indent shall then be signed by the head of the institution (Superintendent or the Civil Surgeon as the c a se ma y be ) o r b y his A ssista n t if th e la tte r is so authorized in writing

(e) The indent book is then presented to the main Store for effecting issue (f) The Store will then prepare issue vouchers (Annex B) in triplicate as directed

in Paragraph V (b) supra The supplies and the Indent Book are taken back by the Ward Section- i n - charge after signing the first copy of the issue voucher

(g) Te supplies after arriving in the WardSection shall be entered on the WardSection stock register which is prepared on a proforma (Annexure E) and page number of each entry be shown o n t h e 2 n d a n d 3r d copies of the Issue

voucher The 2 n d copy of the voucher is to be retained in a file in the wardsection but the 3r d c o p y s h o u l d b e r e t u r n e d t o t h e s t o r e b e f o r e s u b m i t t i n g a fresh indent The Store has to be maintain separate files of the 3 r d copies Wardsection-wise

VIIIHOW OFTEN TO INDENT

(a) A wardsection ndash i n -charge should work out an average weekly expenditure of each item and efforts be made to replenish the WardSection stocks every week

( b ) T h e M a i n s t o r e i n o r d e r t o a v o i d h e a v y rush of work should fix a day of issue for each major specialty T w o or th r e e minor spe c ia ltie s c a n be gr o upe d f o r one day

IX EMERGENT INDENT It is very likely for unforeseen reasons either the weekly indent of WardSection stock might get exhausted earlier or something which was not there in the lsquoweekly indentrsquo is required Under such circumstances an ldquoEmergent Indentrdquo could be made out in the usual manner but under the signature of the Unit-i n- chargeconsultant and it must be countersigned by the head of the institution (and not by his assistant) These supplies have also to be entered in the wardSection stock books like others

13

X HOW TO INDENT

(a) The ward Section -i n - c h a r g e s h o u l d e n s u r e t h a t t h e s t o c k s u n d e r t h e i r c h a r g e a r e not unnecessarily large and only a realistic quantity is indented once a week

( b ) The indent should not be made out in the names of the patients or by bed numbers The indent should be for the Wardsection as a whole

XI KEEPING OF RECORDS IN WARDS AND SECTIONS

(a) A set p r o f o r m a ( A n n e x u r e E ) s h o u l d b e u s e d i n t h e w a r d s e c t i o n f o r s h o w i n g u p receipts and issues Balance of expenditure for each item to be drawn out every morning by nursecompounder in charge before writing out the Indent or before restarting work The medica l O f f ic e r r e side nt in c ha r g e sh ould a tte st th e e ntr ie s after satisfying himself- by random checking at least once a week

( b ) To support the above mentioned expenditure the Bed head Tickets (treatment charts) are very important Each medicine prescribed should be legibly written indicating the total quantity prescribed if the medicine is to be deleted from treatment the fact should be mentioned as to how much of the drug was issued to the patient before switching on to another drug The suggestion is that a separate treatment card be maintained for each indoor patient ( Annexure ndash G) A summary s h o w i n g t h e t o t a l a m o u n t o f t h e p r o p r i e t a r y d r u g s c o n s u m e d b y t h e p a t i e n t d u r i n g is hospital stay be worked out and noted in the summary card

XII ACCOUNT ABILITY OF DRUGS BROUGHT BY THE PATIENT OR RECEIVED IN DONATION BY THE WARDSECTION _IN -C H A R G E

The drugs receoived from the non - governmental sources should be entered on the receipts side of the WardSection Sto c k b ook a n d issu e s to show n a s in th e o the r cases on the issues side

XII RSPONSIBILITY OF STORES AT VARIOUS LEVELS (a) The head of the institution shall be held responsible for non-observance of

rulesprocedures laid down by the Government ( b ) The Medical officerresident in charge of the stores and the store keeper shall be

held responsible for any irregularity found in the stores or for ignoring the ordered pattern of working It shall be the duty of the Medical officer Incharge of the Stores to occasionally check the WardSection Stock-b o o k s t o t a l l y t h e e n t r i e s made in the 3 r d copy of the Issue vouchers [as laid down under V (b)supra ]

(c) The Medical officerresident in charge of the WardSection shall be responsible for irregularities in indenting stocksfor maintaining stocks much in excess of the req uirement and for improper keeping of BED HEAD TICKETS (treatment chartsCards)

( d ) The NurseCompounder ndash i n -charge of the WardSection shall be responsible for shortages in stocks for putting up inflated indents and or for not taking into account medicines b rought by the patientson the WardSection stock-books Heshe shall also be held responsible for ensuring proper distribution of medicines to each and every patient under his her charge

XIV DISTRIBUTION OF MEDICINES FROM OUTDOOR DEPARTMENT (A) ( a ) T h e r e are proprietary and non -proprietary medicines (like mixtures ointments

and lotions) which are to be distributed gratis to patients 14

(b) The Outdoor incharge shall arrange to maintain a stock of common drugs (list of which shall be prepared by the Head of t he Institution) and arrange to replenish the stocks once a week as has been laid down for wards (c) No proprietary drugs shall be issued on the prescription of an intern ( d ) The Head of the institution shall make out a list of drugs which can be issued on

the prescription of a houseman from the Outdoor stock without the countersignature of any other authority

(e) The residents can prescribe any drug from Outdoor stock without the counter signature of any authority

(f) The Consultants can prescribe any drug to any ot h e r o u t e r p a t i e n t e v e n i f i t i s n o t s t o c k e d i n t h e o u t d o o r b u t t h i s s h a l l h a v e t o b e c o u n t e r s i g n e d b y t h e h e a d o f t h e institution for issue from The Main Store

(B) T h e p e r s o n i n c h a r g e o f t h e O u t d o o r m e d i c i n e s s t o c k s h a l l k e e p a r e c o r d o f t h e q u a n t i t y o f t he medicines issued to each patient and instead of writing the name and other details e may only put down the Registration number of the patient and the quantity issued

At the end of the day he must work out the total expenditure of eac item and draw it s balance

The Medical officer in charge of the Stores and the Head of the institution sould check these records at least once a week and affix is signature to confirm their inspection

(C ) No proprietary medicine shall be issued without a valid issue s l i p ( A n n e x u r e- F)

(a) For Housemen the slip would be of brown colour ( b ) For residentsDemonstrators it shall be of pink color (c) For consultants the issue slip should be white ( d ) All issue slips should be printed and pages serially numbered (e) T h e d o c t o r s t o w h o m s u c h i s s u e s l i p s w o u l d b e i s s u e d s h a l l b e h e l d

responsible for their sa f e ke e ping a n d th e y w ould e n su r e tha t th e se slip s would be printed and serially numbered

(f) The doctors prescription slips (for issue from hospitals) of proprietary drugs be prepared in du plicate with the help of carbon One copy should be given to patient for obtaining medicines from the Stores and the other would remain in the Doctors Prescription Slip book

(g) Every issue Slip should be signed and below the signatures a rubber s t a m p s h o w i ng name and designation be affixed The Store people would n o t h o n o u r s l i p u n l e s s t h e n a m e o f p r e s c r i b e r i s c l e a r a n d h i s a t t e s t e d signatures are available to stores

( h ) The Store Staff would file prescription slips of each doctor separately to facilitate the scrutiny at least once a month by the Head of the Institution Such a Scrutiny would reveal over prescribing of or injudicious use of drugs

(C) Proprietary medicines should not be issued for more than three days requirement at a time The only exceptions being cases for cancer pulmonary tuberculosis and leprosy In exceptional cases an officer not below the rank of a Consultant can prescribe for more than 3 days but after the countersignatures of the Head of the Institution

15

XV LOSS BREAKAGE DAMAGE ETC

(A) Any loss of public money departmental revenue of receipts stamps stores or other property held by or on behalf of the Government caused by defalcation or otherwise discovered in an office or institution should immediately be reported by the officer concerned to the head of department through his immediate superior as well as to the Accountant General if the loss exceeds Rs 20000(fig of 1977) (for Proforma see Annexure I)even when such loss has been made good by the party responsible for it Such reports must be submitted as soon as possible and soon after suspicion arises that there has been a loss they must not be delayed while detailed enquiries are made

When the matter has been fully investigated further and complete report should be submitted of the nature and extent of loss showing the errors or neglect rules by which such loss showing the errors or neglect of rules by which such loss was rendered possible and prospects of effecting such recovery

The s ubmission of such a repot does n o t d e b a r t h e l o c a l a u t h o r i t i e s t a k i n g f u r t h e r a c t i o n which may be deemed necessary like handing over the case to the police

Every Government servant should realize fully and clearly that he will be held personally responsible for any loss sustained by the government through fraud and negligence on is part and that will also be held personally responsible for any loss arising from fraud or negligence on the part of any other Government servant to extent to which it may be shown that he has contributed to loss by his own action or negligence

A s s o o n a s s h o r t a g e i n s t o c k o r l o s s i s d i s c o v e r e d a p a r t f r o m r e p o r t i n g t h e m a t t e r a responsible officer should be deputed to investigate the matter

W h e r e t h e r e i s n o l i k e l i h o o d o f a d e l i b e r a t e t h e f t b u t l o s s i s a result of neglect onlythe loss should be made good by the person on whose charge or custody the article lost remained

(B) As soon as damage or breakage of Government property is detected certain steps mentined under should be undertaken-

(a) A p r o m p t t h o ro u g h i n v e s t i g a t i o n i n t o t h e c a u s a t i o n o f b r e a k a g e o r d a m a g e s h o u l d be undertaken by the doctor-i n -charge of the WardSection or by the Head of the Institution

( b ) The investigating officer should draw conclusions as to whether the breakagedamage has been a result of-

(i) C a r e l e s s a n d n e g l i g e n t h a n d l i n g ( i i ) Unpredictable action of the patient for whom the equipment was

being used (iii) Accidental ( i v ) Manufacturing Defect

A report is then prepared in duplicate by person in charge of the article under question on the lsquobreakage and loss proformarsquo (See Annexure H)

16

These reports have to be signed by the investigating officer and are to be then submitted to competent authority for suitable action One copy which is returned is to be kept with the Stock Register In cases where the b r e a k a g e o r d a m a g e i s o f s u c h b i g g e r d e g r e e t h a t s atis factory repairs are not possible a n d if suc h b r e a k a ge o r da m a ge is o f su c h a de gr e e that satisfactory repairs are not possible and if such breakage or damage has been caused-

( i ) B y a G o v t s e r v a n t because of negligent or careless handling cost of the article should be recovered from him and credited to the treasury (ii)On account of reasons mentioned above that is un predictable action of the patient accidental or manufacturing defectthe article could be written offsubject to powers delegated to the concerned for such purpose

(C )Shortages detected during biannual physical verification of the Storeshave to be dealt in a similar manner

(D) it shall be at discretion of the competent authori ty (who is empowered to write off the loss) to reduce the amount of recovery upto 50 of the cost of article provided that before arriving at such a decisionhe has taken into account the following points (a) Normal life span of the article under questi on (b) Period for which it has been in use (c ) Condition of the article at the time of loss or damage and (d) Whether it was on account of careless or negligent act or not

XVI PROCEDURE FOR WRITING OFF STORES

(a) When any Stores become unserviceable otherwise than in ordinary course or by fair wear and tear their value should be treated as loss to the Government and in such cases cost should be recovered from the person responsible for his negligence

( b ) A s t r i c t w a t c h s h o u l d b e k e p t o n t h e m e d i c i n e s w h i ch bear an expiry date and if there is no likelihood of their being utilized locally intimation of the fact should be sent to Directorate of Health services and also to all o t h e r d i s t r i c t s s i m u l t a n e o u s l y s o t h a t t h e y c a n b e p u t t o u s e b e f o r e t h e expiry date In the event such a course is not followed and the Government i s p u t t o l o s s c o s t o f t h e m e d i c i n e i n q u e s t i o n s h a l l b e r e c o v e r e d f r o m t e defaulter

(c) For declaring articles as unserviceable a Committee of three members should be formed in each officeinstitution This Committee should examine each and every article brought before it and should record full reasons for condemning them and also say how the articles condemned have to be disposed of-whether by sale (by public auction) or otherwise

I f t he local Authority is not competent to write off the articles condemned by the Committee it should send the proposal to the higher authority for suitable a c t i o n

17

In Institutions where there is only one doctor a list of articles to be condemned should be p r e p a r e d a n d o r d e r s o n i t b e o b t a i n e d f r o m t h e inspecting authority during inspection

While preparing any list of articles for condemnation details regarding the date of purchase date of receipt period during which it remained in use usual life of the article and its purchase price should be noted against each item

( d ) The condemned articles should not be struck off the Stock Register till the competent authority sanctions its write ndashoff Details of Authority under which the article has been written off should be mentioned in stock register

XVII DISPOSAL OF WRITTEN OFF ARTICLES

Articles like linen should be torn into strips 10cm width so that they could be burnt or given to Government Jails for making carpets

Items like bed -pans bowlsurine po ts etc should be crushed and kept for auction

Brass utensils have also to be crushed to destroy their shape and could be either auctioned or after inviting rates from several dealers could be locally sold to highest bidder

In case when condemned ar ticles have to be sold by public auction they should be stored safely and the Government Auctioneer be intimated In case he expresses his inability to undertake the auction the officer should proceed with the auction departmentally The sale proceeds in either case should be credited to the Treasury as miscellaneous receipts under the Proper head of account

XVIII PHYSICAL VERIFICATION (a) The stocks held by officesinstitutions in various sections should be physically

verified twice a yearin the months o f April and October ( b ) Checking should be done by an officer other than te one who holds the charge of

Stores (c) Verification should be done in presence of officer holding the charge of Stores ( d ) All discrepancies found during the verification should be properly investigated

and accounted for

(j) Any excess detected during verification should be entered in the Stock book as Receipts with the remark ldquo Excess found on verificationrdquo

(ii)any shortage should be noted in issues column of lsquo Issuesrsquo described as lsquoshortage fou n d o n v e r i f i c a t i o n rsquo

XIX ANNUAL STORES ACCOUNT This account should be prepared according to the instruction issued from the department from time to time This should account for the outgoing financial year on the following lines -(a) Cost of the articles under various heads on the last day of the previous

year 18

( b ) Cost of the articles under the various Heads Received during the year (c) Cost of various articles written off during the year under review ( d ) Cost of the articles on the last day of the year or on the firs t d a y o f t h e

financial year following

19

Annexure A WardSection Indent Register No Issued on

Name of institution Page Folio No

Serial no Name of Article Quantity in Stock

Quantity required

Prepared by Approved by Recd by Note-Indenting Officer to sign and affix seal with name and

designation below the last item to avoid additions in one strokeno issues to be made by storesif Issue vouchers of

previous Indent has not been returned back by the WardSection

20

Annexure B Issue Voucher No (printed number)

Supplied to Wardsection Date

Indent no

Serial no Name of Article Quantity in Stock

Quantity required SB No

Stores-in MO Resident in Sign of charge charge WardSection

NurseCompounder Prepared by Recd Approved by by

Note-Indenting Officer to sign and affix seal with name and designation below the last item to avoid additions in one strokeno issues to be made by storesif Issue vouchers of previous Indent has not been

returned back 1st copy-Stores 2nd copy -Wardsection3rd copy-Tobe reurned to sores with Stock book entries

21

Annexure C

STOCK REGISTER FOR DEAD STOCKS

SERIAL NO DATE OF RECEIPT

Article with description

No of pieces Cost Details of

Bill Signature No Disposed

Date of disposal

Manner of Disposal

with Authority

Value realised Signature

1 2 3 4 5 6 7 8 9 10 11 12

P r e p a r e d B y C h e c k e d b y A p p r o v e d b y

Date Designation Name of Institution

22

Annexure D

STOCK REGISTER FOR EXPENDABLE ITEMS Name of article

Date

From where

received with cost

Quantity Signature To whom issued Quantity Balance Signature

1 2 3 4 5 6 7 8

23

Annexure E

Receipt amp Issue Register for WARDSSECTIONS (one or more pages as per requiremnt for each medicine)

NAME OF MEDICINE RECEIPT ISSUE

DATE Quantity In Stock

Date of

Issue

Issued toMention Bed no amp

quantity (in bracket) (For

Outdoor cases give Regd No)

Balance Signature

24

Annexure -F

OUTDOOR FREE MEDICINE SLIP In Duplicate

Name of Patient Registered No Date

Sr no Name of Medicine Quantity

Seal amp sign of doctor

25

Annexure-G

TREATMENT CARD

WARD NO

NAME OF PATIENT BED NO DATE amp TIME OF ADMISSION DATE amp TIME OF DISCHARGE

DATE MEDICINES PRESCRIBED SIGNATURE

26

ANNEXURE -H

PROFORMA FOR BREAKAGE amp LOSS

NAME OF OFFICEINSTITUTION DATE PLACE

SRNO NAME amp

DESCRIPTION OF ARTICLE

COST DATE OF PURCHASE

REASON CAUSE OF BREAKAGE

RECOMMENDATION OF INVESTIGATING AUTHORITY

Signature

Orders of the Competent Authority

Signature

27

Annexure ndash I Loss- Procedure for Reporting

1 The exact nature of the defalcation 2 The full extent of loss 3 The actual period covered by the defalcation 4 The defects in the negle c t o f r u le s by w hic h the loss was rendered possible

and circumstances which facilitated the defalcation 5 The names of the officials held personally or technically directly or

indirectly and wholly or partially responsible for the irregularity c o m m i t t e d i n t h e c a s e

6 Whether the c a s e a s b e e n J u d i c i a l l y t r i e d i n a c o u r t o r n o t i f s o c o p i e s ( i n duplicate) of the Judgment may please be furnished Copy of police report may also be furnished

7 The remedial measures adopted as safeguards against the losses hereafter 8 The prospects of re covery of the loss and he action taken to effect

recovery together with the amount recovered 9 Head of Account to which the Loss is debitable may be informed

Signature of Head of Office with seal

NoteA copy of this report is to be sent to AGMPThis is as per M P Finance Code Vol I

28

STORAGE AND STOCK MANAGEMENT

29

Foreword

The New Drug Policy 2009 is being implemented in the State of Madhya Pradesh

In order to have a proper procedure for Storage maintenance and expiry management of the drugs it is necessary to follow Good Storage Practices with Standard Modules for pharmacistStore keepers

Proper guidelines on Storage Practices can lead to better Stores and inventory upkeep with medicines being properly stored in racks with proper cleanliness and hygiene

This is a step towards storage maintenance and expiry management at the various stores in the state Looking forward to see that the heads of all health facilities take benefit from this module

D ir e c t o r M e d i c a l S e r v i c e s

30

INDEX

Sr No P a r t i c u l a r s P a g e

1 S T O R A G E A N D S T O C K M A N A G E M E N T 4

1 Quarantine and checking of stocks 11 Quarantine area 12 Checks to be carried out on new stocks

2 S t o r a g e 21 Need for proper storage 22 Different patterns of storage 23 Different means of storage 24 Temperatureclimatic conditions 25 Special storage of supplies 26 Storage and stability of medicines

3 Stock Control and Expiry Monitoring 31 Stock control 32 Stock rotation and expi r y m o n i t o r i n g

4 Other aspects of storage 41 Design of a storage area 42 Cleaning and maintenance 43 Product recalls 44 Returned goods

2 A p p e n d i x 1 Templates of letters for use if found not of Standard Quality [Frozen and expired goods ]

Frozen Drugs-ordered to return to the Suppliers-reg(New drug policy 2009)

Frozen Drugs-ordered to return to the Suppliers- for issue of gate pass after verification reg(New drug policy 2009) Stop instruction-reg(New drug policy

2009) Appendix II Material handling in drug stores

31

3 PROCUREMENT ndash Government Order Relating to

the Management of Stores

(Reproduced for reference material on basic

procedure in decentralized system followed by

Health facilities in 1977)

54

F L O W C H A R T S f o r a BI R D S E Y E V I E W o f

P R O C U R E M E N T

5 5

ACQUISITION OF STORES 6 1

PLACING OF ORDERS 6 2

RECEIPT OF STORES 6 2

CUSTODY 6 3

ISSUE OF STORES Maintenance of Stock Books

6 3

PROCEDURE OF INDENTING FOR WARD amp OTHER SECTIONS OF THE INSTITUTION

6 4

HOW OFTEN TO INDENT 6 5

EMERGENT INDENT 6 5

HOW TO INDENT 6 5

KEEPING OF RECORDS IN WARDS A N D S E C T I O N S

6 6

ACCOUNTABILITY OF DRUGS BROUGHT BY THE PATIENT OR RECEIVED IN DON A T I O N BY T H E WARDSECTION _IN - CHARGE

6 7

RESPONSIBILITY OF STORES AT VARIOUS LEVELS

6 7

DISTRIBUTION OF MEDICINES FROM OUTDOOR DEPARTMENT

6 7

LOSS BREAKAGE DAMAGE ETC 6 8

PROCEDURE FOR WRITING OFF STORES 6 9

DISPOSAL OF WRITTEN OFF ARTICLES 7 1

FORMATS TO BE USED 7 3 - 81

32

STORAGE AND STOCK MANAGEMENT The expiry periods of pharmaceutical products have meaning only if the products are stored under proper conditions otherwise products are likely to lose their potency before the actual date of expiry

A pharmacist is a vital link in the distribution chain for pharmaceutical products The medicinal products remain for a long period during the distribution cycle at the wholesaler and at retail pharmacies It is therefore very important to maintain proper storage conditions in these units

Every community pharmacy however large or s mall needs to store and manage its medicine stocks effectively There must be systems to ensure

middot bullbull Secure storage middot bullbull Clean and correct environmental conditions during storage middot bullbull Accurate and effective record keeping middot bullbull Effective stock rotation and expiry monitoring middot bullbull Effective fire and theft prevention middot bullbull Effective rodent pest control

For easier un derstanding this module has been divided into the following sections

1 Quarantine and checking of stocks 11 Quarantine area 12 Checks to be carried out on new stocks

2 S t o r a g e 21 Need for proper storage 22 Different patterns of storage 23 Different means of storage 24 Temperatureclimatic conditions 25 Special storage of supplies 26 Storage and stability of medicines

3 Stock Control and Expiry Monitoring 31 Stock control 3 2 S t o c k r o t a t i o n a n d e x p i r y m o n i t o r i n g

4 Other aspects of s t o r a g e 41 Design of a storage area 42 Cleaning and maintenance 43 Product recalls 44 Returned goods

33

1 QUARANTINE AND CHECKING OF STOCKS

11 Quarantine Area D r u g S t o r e pharmacies receive stoc k s f r o m su pplie r s a c c or d ing to pur c h a se o r d e r s T he stock that is received must be visually checked for quality and quantity The stocks must be kept in a separate area until the checking is done to avoid intermixing with existing stock This necessitates the presence of a separate area within the pharmacy w h e r e i n t h e storage and other checking of stocks can be performed This area is called the QUARANTINE AREA This area should be marked and identified adequately to distinguish it from other areas

The area may be marked using different means 1 ) A s m a l l board saying Quarantine on a separate table used exclusively if it is in the middle 2) A board on the wall if the table on which the quarantine stock is placed is against the wall

middot Stock received from wholesalers should be immediately transferred t o t h e Quarantine Area

middot In the Quarantine area the stock may be stored on racks shelves or in cupboards to prevent ingress of moisture dirt and other contaminants

middot Regular stocks from the pharmacy should not be left kept in the quarantine area Special care has to be taken in case of refrigerated medicines supplied by the suppliers so tha t the y do not remain in the quarantine area for long periods of time They should be immediately checked on receipt and transferred to areas for refrigerated storage s o a s to maintain the cold chain bull

Advantages of having a separate Quarantine Area middot Avoids cross mixing of newly arrived stock from existing stock till it is checked middot Lays stress on checking the quality of the stock received middot S to ck checking ensures t hat defective andor expired goods do not enter the storage areas

34

bullbull

bullbull

12 Checks to be carried out on new stock

Unpacking and checking stock

Supplies received should be unpacked and checked in the quarantine area Staff doing the checks should be adequatel y trained in what they have to check when stock arrives

Checking should be seen not simply as counting the units received but as a part of the quality assurance system bullThis should include middot Visually inspecting the packaging middot Checking the integrity of containers middot V erifying the completeness and leg ibility of la b e ls ( a ppr o ve d dr u g name strength any special storage instructions and expiry date)

bull

The expiry dat e should be checked to ensure that there is adequate shelf life remaining

Supplies should be individually checked using a checklist 35

Checklists

36

The wholesaler supplying the product should be notified immediately in case of any discrepancies ( and the details should be recorded in a register) and sent in a written format to the supplier It should include middot Missing boxes or cartons middot O p en tampered boxes or cartons middot Missing supplies middot Differences in the actual quantity and the quantity shown on the packing middot Additional medicines that had not been ordered but have been supplied middot D a m a g e d b r o k e n o r p oor quality medicines middot Any other discrepancies

The purchase invoices are an important aspect to be considered The invoiced documents should be signed and filed for reference as per the Drugs and Cosmetics Act and retained for at least 3years

If the wholesaler supplies medicines as an emergency without a bill or against a delivery challan

middot The supplies should be checked for integrity and inspected for damage middot The details of supplies received should be recorded middot The supplier should be asked t o send the bill as early as possible middot When the bill is received it should be checked against the details recorded and anomalies if any should be reported to the supplier

To keep a track of the received stock maintaining a S t o c k R e c o r d C a r d c a n b e very useful The entries in the stock record card can be made while checking the stock received STOCK BIN in the stores should have Stock record card

Maintaining a stock card for every product may not be very practical for a retail pharmacy however it could be maintained for costly medicines Nowadays it is much more practical and easier to maintain records using computers

The pharmacist should ensure that medicines manufacturedmarketed by a company are received only through an authorized distribution network of that company This is important to prevent spurious and counterfeit drugs from entering the pharmacy

37

2 STORAGE 21 The need for proper storage The storage of medicines and other products is an important requirement of Good Pharmacy Pr actice Appropriate storage of medicines is essential -

middot bullTo ensure that the potency is maintained middot bullTo prevent deteriorationspoilagedegradation middot bullTo ensuremaintain physical integrity

To ascertain that the quality and safety is maintained throughout their shelf life Storage requirements need to be considered on 2 aspects

a) Integrity of medicines Medicines should be stored in such a way so as to maintain their integrity and potency middot Maintain the right temperature required middot Protect from excessive humidity middot Keep medicines away from direct sunlight middot Protect from pests and rodents

b) Physical location middot Should be easy to locate middot Accessible middot Orderlysystematically placed

2 2 D i f f e r e n t p a t t e r n s o f s t o r a g e The pharmacist could follow any of the different patterns of storage The pattern of stora ge should be selected in such a way that it facilitates speedy and efficient dispensing of medicines

The pattern of storage could vary with each pharmacy experience usual practiceroutine of staff and the person-in charge and also depending on space av ailable turnover etc (i) The medicines could be stored c o m p a n y w i s e ie the medicines manufactured by one company should be grouped together and kept in one place Within each company shelfshelves the medicines may be placed in alphabetical order for easy and quick placement and removal Also bottles tubes boxes etc may be segregated within that shelf

38

(ii) The medicines may also be stored in a lphabe t ic al o r de r ie they are placed in order from left to right based on their name The first letter of the name is used to g r o u p t h e m e d i c i n e s t o g e t h e r a n d k e e p t h e m i n o n e l o c a t i o n I n s o m e p h a r m a c i e s a l l t h e strip packing are placed in drawers or boxes in alphabetical order each box or drawer containing strips of one particular alphabet This system ensures that the strips always remain e n c l o s e d i n t h e b o x e s d r a w e r s a n d a r e n o t e x p o s e d t o d u s t T h e d i s a d v a n t a g e i s that it might lead to mix -u p o f strips in the same drawer and it may cause a problem incase of similar looking strips in which case a wrong medicine may be dispensed Secondly cut strips lying around in the drawer may lose their identity if the batch n u m b e r andor expiry date is not seen on the cut portion of the strip

39

(iii) The medicines may be stored according to their therapeutic class ( e g a n t i b i o t i c s anti asthmatics or anti hypertensives) ie the medicines are kept together based on their pharmacological or therapeutic action

(iv) The medicines may be stockedsegregated according to dosage forms eg l i q u i d s (bottles) solid oral dosage forms eye drops rotacaps ointments etc all stored on separate shelves

Always Remember I Storage of prescription medicines should preferably be separate from OTC medicines OTC medicines especially those that a r e a d v e r t i s e d m a y b e d i s p l a y e d f o r c l i e n t s t o select or to ask questions about [OTC-O v e r t h e c o u n t e r ] II Storage according to temperatures is a must no matter which pattern of storage is followed Also within a particular storage area segregated storage may be maintained In a refrigerator for example medicines may be stored in trays racks and the freezer according to the temperature required

40

Whatever pattern of storage is selected all the personnel should ensure that middot The stocks are stored in an orderly manner middot The medicines are kept back in the same place from where they were removed middot All medicines are arranged neatly once in a while

middot The personnel should be careful while storing the medicines middot They should not throw the medicines haphazardly 23 Different means of storage

middot Within each temperature and security zone medicines must be stored so that they are easily accessible and protected against damage

middot Basic means of storage include shelves racks and drawers middot To prevent dust from entering the shelvesracks it is ideal to have glass

shutterssliding glass doors This can however be disadvantageous because accessibilityspeed is hampered in removing a product from the shelf because the glassshuttersliding glass has to be

41

opened m o v e d e v e r y t i m e a p r o d u c t h a s t o b e p i c k e d u p U s e o f a i r c o n d i t i o n e r s f o r t h e p h arm acy with a closed door at the e n t r a n c e o r a n a i r c u r t a i n c a n r e d u c e t h e d u s t problem In such cases the shelvesracks may be left o p e n

bull

middot Direct storage of cartons on the floor should be avoided because besides being an unhealthy practice the contents may also be damaged by moisture bull

middot Store medicines preferably in shelves with glass shutters for visibility middot Closed shelves further prevent dust from going in especially in India where most

pharmacies are located along busy roads middot Some medicines have to be refrigerated or stored in a cool or cold place Having a

refrigerator or two (as per the need of the pharmacy) is essential to store suc h medicines at temperatures mentioned on the label bull

42

Refrigeration middot All cold chain equipment should meet required standards middot Improvement in refrigeration technology has provided frost -free refrigerators

Pharmacists should opt for frost-free refrigerators as they are easy to maintain and protect printed packaging materials Conventional refrigerators may cause water falling from trays below the freezer on medicines stored in the refrigerator thus causing soggy labels

middot bull Frost-free refrigerators also provide separate and large compartments for the freezer portion (required for storing medicines needing sub-z e r o t e m p e r a t u r e ) and the main storage area with separate doors so that opening one door does not disturb the storage temperature in the other compartment

Care should be taken to keep the refrigerator on 24 hours a day It should not be switched off after working hours It is advisable to have an inverter connected to the refrigerator so that the refrigerator re mains working even when there is a power outage

middot The refrigerator door should be closed tightly middot The refrigerator door should not be left open for too long middot Space should be left between medicines stored in a refrigerator to allow air to

circulate middot The ref rigerator should be placed about an arms length away from the wall

This will increase air circulation thus not affecting the cooling within the refrigerator

middot Vaccines should not be stored on refrigerator door shelves as they are exposed to warmer temperatures each time the door is opened Vaccines should always be stored on the middle shelves of the refrigerator

middot Refrigerated medicines should not be left out of the refrigerator for more than a few minutes

43

middot Consumable products like juices energy drinks e t c s h o u l d n o t b e s t o r e d a l o n g with medicines in refrigerators If required they may be kept in a separate refrigerator

middot An adequate number of refrigerators should be planned to store the entire stocks requiring refrigerated storage

middot Adequate procedures should be followed for defrosting cleaning and maintenance of refrigerators

middot Icefreeze packs should be kept in the freezer compartment so that they can be used for transporting cold temperature medicines The packs can be given to clients along with the medicines requiring cold temperature storage so that the temperature is maintained till the client reaches home and can then put the medicines in a refrigerator) Freezer packs can also be used to keep medicines temporarily in case there is a power outage or refrigerator breakdown

Activity

Prepare a SOP (Standard operating procedure chart) for cleaning a refrigerator Discuss it with your staff finalize its maintenance once a month through AMC -A n n u a l Maintenance contract CMC - Comprehensive maintenance contract and put it up on the pharmacy refrigerator Put the Purchase Order details name of manufacturer Phone of Service Engineer and a register to login the Machine service and down timeService reports may be maintained properly

Refrigerator monitoring and maintenance

middot bullIt is important to carry out routine monitoring and maintenance of the refrigerators and to organize an effective repair system

middot bullThe temperature in the refrigerator must be monitored and recorded routinely at least once a day

middot Any breakdown must be reco rded including the period during which the medicines were exposed to uncontrolled temperatures Medicines may then be kept or discarded depending on the problem guidelines or the manufacturers advice

middot Cold chain monitor cards and devices in or on packages that change color or otherwise alert staff to potential damage assist in monitoring (These are likely to be introduced in India soon)

middot It is essential to have a contingency plan in place before a refrigerator breaks down An arrangement can be made to move the contents to a private refrigerator elsewhere in the community or to obtain a regular supply of ice packs until the defect is rectified

Put filled water bottles in the bottom half of the refrigerator door in order to provide cooling in the refri g e r a t o r w h e n t h e r e i s a p o w e r o u t a g e T h i s m i g h t t a k e c a r e o f t h e temperature when there is no current for a couple of hours If the power outage is expected to last for several hours special arrangements such as an inverter UPS have to be made to keep the refrigerator constantly running in the absence of electricity middot Defrost the refrigerator in case of excessive ice formation and preferably at regular

intervals Keep a record of the same

44

2 4 T e m p e r a t u r e c l i m a t i c c o n d i t i o n s

i) Temperature control middot The medicines in a pharmacy need to be stored at appropriate temperatures to

maintain their stability middot An air-conditioned environment where temperature can be controlled is

recommended for pharmacies Air conditioning offers the option of setting the t e m p e rature as per requirements

middot bullIt is ideal to have an air conditioner to maintain the temperature below 25 C as most medicines require storage below this temperature Secondly this temperature is pleasing to both the staff and the visiting customers too

middot In the absence of an air conditioner circulating fans may be used middot This need is felt even more in certain parts of India where temperatures soar above 45

C and some areas where it falls to sub zero temperatures In such cases temperature maintenance is essential to prevent deterioration of medicines due to unnecessary exposure to drastic temperature fluctuations

middot This need is felt even more in certain parts of India where temperatures soar above 45 C and some areas where it falls to sub zero temperat u r e s I n s u c h c a s e s temperature maintenance is essential to prevent deterioration of medicines due to unnecessary exposure to drastic temperature fluctuations

i i ) Humidity or moisture control Moisture or humidity can adversely affect the stability of me dicines such as tablets capsules powders

45

Gelatin capsules become soft and swell on absorption of moisture The drug content of tablets may undergo surface hydrolysis The presence of moisture may encourage the growth of microbes It is therefore essential to control humidity

To reduce the effect of humidity the following suggestions may be followed -middot Open the windows to allow air circulation Use a fan to circulate fresh (outside) air middot In humid climate a dehumidifier is useful for preventing mo i s t u r e d a m a g e ( i n t h e absence of an air conditioner) middot For bulk containers of tabletscapsules do not keep the container open for a long time and replace the lid or closure immediately after taking out the required number of medicines for dispensing middot Do not allow the medicines to touch the floor or the walls The walls may be damp and may cause moisture absorption damaging the product

middot Calibrated thermometers and manometers can be used to detect temperature and humidity in the pharmacy

middot Periodici t y of checking the temperature should be fixed middot The climatic conditions should be recorded and documented middot Temperature charts should be available for ready reference

Documentation is one of the core activities for achieving and maintaining quality It is one of the most essential components of validation Temperatures in various areas

46

including refrigerators should be recorded at a predetermined periodicity usually daily at the hottest time of the day and such documents should be preserved i i i ) Storage conditions A number of storage conditions are mentioned on the labels of medicinal products These conditions have to be properly interpreted and appropriately complied with

According to the Drugs and Cosmetics Rules 1945

1 The term cool place means a place having a temperature between 10 C and 25 C

2 The term cold place means a place having a temperature not exceeding 8 C In case of storage conditions for specific products please refer to Schedule P The Drugs and Cosmetic Rules 1 9 4 5

The Indian Pharmacopoeia specifies the following storage conditions -

Wherever the condition for storage is not specified medicines may be stored under normal temperature In a country like India however where normal temperatures soar to h i gh temperatures it is recommended that medicines be stored in a cool place

Activity Prepare a list of the storage requirements mentioned on the label of about 20 products in your pharmacy and check if the temperature is maintained

47

25 Special Storage o f s u p p l i e s If the product has no special instructions normal storage conditions apply This means storage in dry clean w e l l -ventilated premises at temperatures of +15 C to +25 C or depending on the climate up to +30 C (WHO1990) Storage instructions are product specific Different brands of the same generic drug may have different storage requirements as they may have different packaging or formulations It is essential to follow the product manufacturers storage instructions to the maximum extent possible Less stable medicines must be stored in specific conditions to maintain their quality or potency

The following products require special storage facilities

middot Products that must be kept frozen (usually vaccines and sera) middot Products sensitive to h eat an d r e q uir in g r e f r ig e r a tio n ( +2 C to +8 C) middot Products that have reduced shelf life at uncontrolled room temperature and need

mechanical ventilation or air conditioning middot Flammable products that require separate fireproof premises middot Products prone to theft o r m i s u s e

Products needing storage in a controlled environment -

The usable shelf life of the following products may be reduced if stored at uncontrolled humidity or at room temperature in hot climates -

middot Some injectables (eg adrenaline) Most injectable preparations are less stable than solid oral forms (tablets and capsules) Injectable preparations in solution are particularly unstable Many injections must be protected from light as well as heat

middot Intravenous fluids (particularly if packed in p lastic containers) middot Some suppositories pessaries creams and ointments These products may melt at

temperatures greater than 30 C Once this happens it is not advisable to use them because the active ingredient in the formula may get unevenly distributed

middot Products containing rubber latex cellulose or some plastics Condoms most sterile disposable medical devices and surgical products such as syringes needles and catheters require protection from excessive humidity and strong light and heat Any o f these conditions may make products brittle stained amp unusable Sterility cannot be assumed if packaging is damaged

In hot climates these products should be stored in the coolest place possible preferably with air conditioning or air circulation fans

48

Products needing freezing or refrigeration-middot Vaccines blood products and many other medicines lose potency if kept even for a

brief period at temperatures outside the recommended range For these products the cold chain must be maintained at every stage of the distribution system

middot Freezing is as damaging as high temperatures for some products including injectable contraceptives ergometrine insulin adrenaline and the DPT DT TT and Hepatitis B vaccines Such products therefore sho uld not be allowed to freeze (not be kept in the freezer compartment)

middot Short periods at room temperature (during transportation or local distribution for instance) may be acceptable for many products (such as ergometrine a n d i n s u l i n ) e v e n t h o u g h s u c h e x posure can to some extent reduce shelf life Other items such as vaccines should always be transported in cold boxes

Storage of insulin injections-

middot Insulin should always be stored in a refrigerator at the recommended temperature of 2 -8 C

middot Insulin should not be kept in the freezer compartment of the refrigerator middot Insulin should ideally be stored horizontally middot It should not be exposed to sunlight or excessive heat middot Insulin suspensions should not be used if the suspension cannot be properly

resuspended due to cake or clump formationbull

Controlled drugs -Narcotics (for example Pethidine injection morphine preparations) and other specified drugs that may be abused are governed by special legislation and regulations The following security measures are suggested in the pharmacy -middot A safe or reinforced double locked cabinet fitted with a light (preferably with a red

bulb) that comes on when the door is opened

49

middot A special register recording details of each receipt or issue with 2 signatures physi cal counting of medicines after each entry and signatures at handover takeover

middot Independent audit (by supervisors and drug inspectors)

Products prone to theft abuse or misuse -

Some medicinesproducts are particularly prone to theft abuse or misuse These include expensive medicines (eg insulin) certain antibiotics and products prone to abuse or misuse like psychotropics etc

Such medicinesproducts should be stored adequately They require stricter record keeping and more frequent stock taki ng than others Periodic audits should be carried out to check for consumption against actual recorded use (registers prescription records stock records etc) to expose any theft or misuse bull26 Storage and stability of medicines Medicines are not stab le indefinitely They are stable for a specific period of time sometimes for a brief period Poor storage conditions accelerate the drug degradation (decomposition) Temperature light and moisture are the most important contributing factors for drug instability It is important to identify and be aware of the potential for instability There is a need to comply with storage requirements to ensure quality medicines for patients It is also important to offer advice to patients too about appropriate storage o f medicines at home The dispensing label should state the storage condition required and be backed up by a verbal reminder especially where special storage is required bull

50

In case stability and storage problems are seen with formulations they should be reported immediately to the representative of the manufacturer and taken out of circulation till the stability problems have been resolved

The pharmacist can easily detect stability problems when products show change in appearance color odor settling of the product contents breaking of emulsions melting of creams oozing of contents from the containers and any such physical changes

3 STOCK CONTROL AND EXPIRY MONITORING 3 1 S t o c k C o n t r o l For economic reasons pharmacists do not like to have stock on their shelves for long periods of time The aim should always be to keep stock at a level that will just meet demand Normally most manufactured medicines have a long shelf life Even then it is essential that there is efficient stock rot ation so that the older stock is used first It is also a good practice to check the expiry date as an integral part of the dispensing process When short shelf life products are involved stock levels may have to be modified to prevent medicines regularl y expiring on the shelves

32 Stock rotation and expiry monitoring In order to avoid accumulation of expired and obsolete stock medicines should be stored and issued according to the following guidelines -middot The stock control system must record the ex p i r y d a t e a n d t h e d a t e o f r e c e i p t middot Stock must be stored so that earliest expiring batches are picked and issued first middot The First In First Out (FIFO) system - In this system the stock which is received

first is sold first This system however may not be useful for pharmacies because most of the stocks carry an expiry date For pharmacies the FEFO system is more practical

51

middot The First Expiry First Out (FEFO) system - In this system the stock having an earlier expiry is sold first The stock with longer shelf life should be placed farthest to the back (or at the bottom in case o f sta c k e d b oxe s) T h is is pa r tic u la r ly impor ta n t with products that have short shelf lives such as vaccines some vitamins antibiotics etc and reduces losses due to expiry

middot E x p i r y dates should be noted on the stock record upon receipt Stock nearing expiry should not be accepted unless it can be used before expiry

Computerization and expiry monitoring In the pharmacy computerization facilitates both checking stocks and expiry mo nitoring and helps-bullbullKeeping a check on products nearing expiry bullbullKeeping a check on non- moving and slow moving products bullbullTo facilitate the removal of medicines nearing expiry from shelves in time to send them back to the wholesaler or supplier

Periodic checking for expiry The expiry date for medicinal products is a critical aspect in pharmaceutical dispensing and due importance should be given to it Periodic checking for expiry of medicines will ensure that the patient will never receive products that have crossed their expiry date During periodical checking of expiry the personnel involved should remove medicines that are nearing expiry bullbullIn -house threshold periods should be set and followed for retrieval of such medicines from the shelves bullbullSuch medicines should be stored separately These should either be dispensed immediately (thus ensuring that they are used before the expiry date) o r t h e y s h o u l d b e returned to the suppliers bullbullA separate area should be designated (cupboard or shelf)marked[FROZEN ZONE] which is adequately marked EXPIRED GOODS- NOT FOR SALE to store all expired stocks FROZEN ZONE

52

Remember Expired medicines are a NATIONAL WASTE So stock only what you can sell Avoid expiries save precious medicines for the nation

Treatment and disposing of expired medicines bullbullProcedures need to be in place for the treatment of expired medicines bullbullThe expired medicines need to be collected and be sent back to the supplier or company for appropriate disposal bullbullRecords must be maintained for expired medicines and how they are disposed off bullbullIn case of medicines that are not returnable to suppliers procedures for disposal need to be followed by the pharmacy in conjunction with the FDA The following procedure can be followed if medicines cannot be returned to suppliers ( T h e b a s i c p h i l o s o p h y of appropriate disposal is to prevent their re- circulation and use) bullbullC u t t h e c o n t ainer in such a manner that the label is also cut In case of tablets and c a p s u l e s d e s t r o y them by disposing them in a bucket of water bullbullUse landfill procedures (deep burial into the ground as per stipulations of Medical Waste Disposal Act prevalent in the respective state) bullbullPour the liquids into the sink and wash away with sufficient quantity of water bullbullKeep a record of such disposal with full details of medicines destroyed Although these measures are usually adopted care has to be taken with such tr e a t m e n t a s studies have shown that flushing of medicines has resulted in tracessmall quantities of medicines being found in waterways and groundwater having potential health and environmental effects

4 O T H E R A S P E C T S 41 Design of storage areas The following important factors need to be considered in design of storage areas -middot The retail outlets in hot areas in summers should be air-conditioned Similarly in

a r e a s o f e x t r e m e c o l d t h e p r e m i s e s w o u l d r e q u i r e w a r m i n g e s p e c i a l l y i n w i n t e r s t o maintain cool temperatures The placement of air -conditioners and heating devices should be such that medicines are not directly exposed to the cold or heat

middot Due consideration should be given to storage requirements of formulations while designing shelves and cupboards in retail outlets Sufficient shelf height should be provided so that all liquid products can be stored vertically As far as possible the shelves should be covered with glass panels to protect medicines from dust and p r e v e n t r a p i d f l u c t u a t i o n s i n temperature

middot Medicines should be stored according to the storage instructions on the labels bullIt is ideal to have a door at the pharmacy entrance to prevent dust from coming in as well as reduceprevent cooled air from going out This may not however be considered feasiblepracticable by many pharmacy owners for fear that clients may not enter the pharmacy because the door may act as a barrier An air curtain is a good alternative to a door

middot There should be minimal direct sunlight falling on the products Particular consideration should be given to premises directly facing the sun

middot bullThe arrangement of lighting in the interior of the premises should also be in a manner that the lights are not focused on the products It has been shown that light causes not only chemical damage but also can catalyze physical changes like moisture uptak e by the products Care should be taken to ensure that only diffused light falls on them

53

middot As far as possible provision should be made for a temperature and humidity indicator device in a pharmacy These devices are now easily available

middot Stability studies o f m e d i c i n e s p a c k e d i n b l i s t e r s h a v e r e v e a l e d t h a t i f t h e s e a r e exposed to light they tend to absorb moisture It is therefore necessary to store them in suitable cartons so that the blisters are not exposed to light Pharmacists should do this even if the manufacturer has not provided cartons

middot Light and temperature sensitive products should not be stored on counters where the light is intense or direct and there is no protection from temperature and humidity

42 Cleaning and maintenance i) Cleaning of storage areas

The storage areas of the pharmacy should be cleaned periodically and cleanliness should be maintained at all times The Standard Operating Procedure for cleaning should be designed and followed accordingly Schedules for cleanups should be laid down and adequate cleaning equipment should be made available

Tips for maintaining cleanliness middot Provide clean pieces of cloth for wiping at various locations in the pharmacy

Replace with clean cloth at regular intervals middot Keep separate pieces of cloth for floors shelves and medicines middot Use a disinfectant andor soap solution to clean floors middot Ensure removal of dust and prevent accumulation of dirt middot Ensure removal of cobwebs middot Use a vacuum cleaner for cleaning areas not easily reachable middot T a k e c a r e t h at breakages are handled and cleared effectively middot Observe the factors leading to waste generation in the pharmacy and take appropriate

measures to tackle the problem middot Record all cleaning procedures performed and maintain all the documents required

For ex a m p l e -bullbullThe floor of the pharmacy may be swept with a broom and swabbed with soap water every morning bullbullThe floor may be swabbed with a disinfectant every week bullbullThe entire premises including shelves and cupboards may be cleaned with a cloth (to remove dust and to check for medicines approaching expiry date or expired medicines) every three months bullbullAll the steps followed should be r e c o r d e d

The floor shelves drawers have to be cleaned and a check should be kept on dust cobwebs spillages due to breakage etc It is therefore essential to have SOPs for cleaning laying down cleaning frequencies allotting responsibilities and maintaining a daily record in the logbook to document all these activities

54

While cleaning dust settled on dosage forms like bottles tubes etc should be removed Before dispensing the products should also be wiped to remove any dust settled during storage

For refrigerators bullbullDefrosting and cleaning should be done at regular intervals bullbullSwitch off the refrigerator while cleaning bullbullCleaning should be done quickly and stocks put back immediately

i i ) Pest control Pests are a serious problem in India where insects reptiles and rodents (eg cockroaches l i z a r d s r a t s s i l v e r f i s h (Deemak - in Hindi ) etc) may find access to the pharmacy storage areas Insects like ants and borer ants may often attack wood in the pharmacy causing d am ag e to shelves cupboardsPest c ontr o l in a p h a r m a c y c a n b e a d i f f i c u l t t a s k b u t t o avoid possible contamination and physical damage to stock it is necessary to keep pests out of the pharmacy premisesPest control measures should be implemented with proper p r e c a u t i o n s t a k i n g u t m o s t c a r e t o a v o i d contamination of medicines

55

Th e following pest control measures c a n be ta ke n f r om tim e to tim e -bullbullRat bait and traps can be placed at various locations bullbullInsecticutors can be used on a permanent basis bullbullInsecticidal sprays and repellants can be used from time to time

i i i ) Fire precautions

Combustible trash such as cartons boxes and other packing waste must not be allowed to accumulate in the store Waste should be deposited in appropriate waste bins and be d i s p o s e d o f f o n a d a i l y b a s i s

F i re detection and fire fighting equipment must be maintained and regularly inspected The pharmacy personnel should receive adequate training in fire fighting techniques and emergency actionFire prevention measures should include a prominently displayed ldquoNoSmokingrdquo sign careful handling and disposal of combustible waste materials and checking of electrical connections at regular intervals

iv) Security middot Doors shutters of the pharmacy should be strong and be fitted with secure locks middot Counters should be designed so that unauthorized personnelclients do not have

access to areas where prescription medicines are stored Access to such areas should be restricted to the pharmacy staff

middot All the pharmacy staff handling supplies should be accountable for their ac t i o n s

56

middot bullSpecial care must be taken in case of Schedule X and manufactured drugs (under NDPS Act) Such medicines should be kept under lock and key and the key should be kept with the Chief Pharmacist or i n h i s a b s e n c e t h e s e n i o r p h a r m a c i s t

v) Breakagespillage and damaged product Products that have been damagedspoiled during storage and handling spillages and broken glassware should be disposed off according to procedures laid down by the pharmacy Broken and damaged products s h o u l d b e p l a c e d i n a segregated area to be returned to the supplier

vi) Inspection Senior staff should inspect all pharmacy areas regularly The shelves and drawers should b e c h e c k e d d a i l y f o r signs of pests and dust Ceiling and walls should be checked for dirt and cobwebs Stock should be checked on a regular basis for deterioration due to climatic conditions

43 Product recalls Products found to be defective should be quickly recalled (withdrawn from the market) The instructions are generally issued either by the manufacturer or the regulatory agency The level of recall is determined by both the degree of risk and the extent of distribution of the product and in India is mainly directed at the distribution chain

On receiving the details of the defective substandard spurious batchbatches of a medicine to be recalled from the manufacturer or the stockist or the FDA the pharmacy should immediately check if the particular b a t c h i s i n s t o c k a n d i f s o s u s p e n d i t s s a l e immediately

Similarly if the regulatory authority in the country bans a particular medicine or FDC the pharmacy should immediately check and remove all the different brands of that particular medicine under consideration

The details of medicines and their batches to be recalled should be available in the q u a r a n t i n e a r e a w h e r e stocks are received and checked This is to ensure that such medicines do not come into the pharmacy

middot The pharmacy should develop SOPs for recall of medicines middot The pharmacy staff should be immediately informed about such medicines and

the details should be displayed in writing in a prominent place in the pharmacy middot Rapid action helps avoid unnecessary exposure to such medicines once the

problem has been d e t e c t e d middot The progress of the recall procedure in the pharmacy should be monitored every

few days to ensure complete compliance middot All stocks of the recalled products should be stored separately from the saleable

stock These can be stored in the expiry cupboard segregated from the expired goods and be appropriately labeled ldquoRecal l e d G o o d s - Not for Salerdquo

The supplier should be notified and asked to replace defective products middot All the details of the procedures followed should be duly recorded in a Recall

Register maintained specially for the purpose The register should include d etails such as -middot Date of the recall middot Nam e of the product

57

bullbull

middot Details of the product (name of manufacturer batch number expiry date) middot Nu m b er of units purchased sold a n d sto c k in ha nd middot Reason for recall middot Nam e of the supplier to whom produc ts w e r e returned along with the date and quantity middot Name and signature of the designated personnel carrying out the recall procedure and recording details middot Name and signature of the chief pharmacist verifying the recall procedures and recording details 4 4 Returned medicines

Medicines may be returned to the pharmacy by clients due to the following reasons -bull

bullbull Unused medicines bullbull Course not completed bullbull Therapy changed by doctor bullbull Side effects experienced by patient bull

bullbull DamagedDefective medicines bullbull Missing or defaced label bullbull Missing tablets in a stripblister bullbull Leakage in bottles bullbull Leakage in strips bull

bullbull Expired medicines

Appropriate SOPs should be framed and followed for their acceptancerefusal and disposal middot bull For unused medicines returned by clients the p harmacy personnel should verify

that these were purchased from their pharmacy They should then be checked for integrity of the packing the dosage form and the expiry date and verified with the client whether they were stored in appropriate conditions This again is at the discretion of each pharmacy

middot The damageddefective medicines returned to the pharmacy should be taken back and stored separately Existing stock of the same product should be checked for similar defects

middot Expired medicines should be accepted from clients at the discretion of the pharmacist and be immediately shifted to the expired goods cupboard These can be stored segregated from the pharmacys own expired goods and be appropriately labelled ldquoExpired Goods returned by clients- Not For Salerdquo

It is advisable not to accept returned medicines requiring cold chain storage (refrigeration) because it cannot be ensured that the cold chain was maintained when the medicines were in the hands of the patientclient middot Appropriate adjustments in t he stocks should be made for medicines

returnedexchanged to update the inventory middot The medicines should then be returned to the respective shelves middot A lsquoReturned Goodsrsquo register needs to be maintained to record all details of returned

medicines

R egister should include such details as-

58

middot N a m e o f t h e p a t i e n t middot Nam e of the product and quantity r e tu r n e d middot Product details such as the batch number and expiry date middot Condition in which received middot Reason for returning products middot Compensatory measures taken wi t h r e s p e c t t o c l i e n t middot Action taken with respect to product middot Name and signature of the personnel accepting the returned medicines and recording details middot Name and signature of the chief pharmacist verifying the recorded details

What the pharmacist would have learnt from this module The storage of medicines is a critical factor in the distribution cycle bullbull Stocks received by the pharmacy should be quarantined in a separate area and necessary checks s h o u ld be performed to ascertain the qua lity a nd quantity of stocks received bullbull Whatever pattern and means of storage used the products should be stored so as to maintain their potency and integrity bullbull Storage conditions should be monitored and maintained on a regular basis bullbull Optimum stock levels should be maintained and regularly monitored for expiry bullbull The design of storage areas should facilitate appropriate storage of medicines bullbull Cleanliness should be maintained in the pharmacy bullbull Adequate measures should be taken in case of returned medicines and recalled products

Optimum storage of medicines is mandatory whether at the distribution stage at the pharmacy or ultimately within the homes of patients The pharmacist has an important r o l e t o p l a y i n t h e s t o r a g e o f m e d i c i n e s i n m a i n t a i n i n g d r u g p o t ency and efficacy and thus facilitating optimum therapeutic benefits Good Pharmacy Practice - IPA -CDSCO - WHO Appendix I Quality Assurance Templates of letters for use if found not of Standard Quality [Frozen and expired goods ]

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated To Name of the Supplier with address

Sub Not of Standard Quality GoMP-Supply of Drugs and medicines-(Codename) Return of Stocks to the Suppliers-reg(New drug policy 2009) Previous letterinvoice ref Sl No Drug Code Drug name

Manufacturing date Expiry date

Supplier address

B a t c h n o

The above items of PO nodated was drawn by the Drug Inspector (Place) on (______________date) as a statutory sampling and declared ldquoNot of Standard

59

Qualityrdquo on -(______________date) by the Government Analyst for the following reasons

- ldquoThe product sample do not confirm to IP specification for (Drug codename with respect to the content of drugrdquo

- ldquoThe product has already been blacklisted by TNMSC on -(______________date) for the failure of (quantity) of batches of drug codenamerdquo

As per the clause of the te nde r d oc um e nt ldquo I f the sa mple s d o not c onf o r m to statutory standardsthe tenderer will be liable for relevant action under the existing laws and the entire stock in such batch should be taken back by the tenderer within a period of 30 days o f t h e r e c e i p t o f t h e l e t t e r f r o m t h e v e n u e

The stock shall be taken back at the expenses of the tendererthe Procurement Authority have the right to destroy such Not of Standard Quality if the tenderer does not take back the goods within the stipulated time

The Procuring Authority will arrange to destroy the Not of Standard Quality drugs within 90 days after the expiry of 30 days mentioned above without further notice and shall also collect demurrage charges calculated at the rate of 2 per week on the value of the drugs rejected till such destructionrdquo

Hence we regret to inform you that you will have to take back the stocks available of the abovesaid batch at your own cost from the drug stores where you have supplied the above batch

Kindly acknowledge the receipt of this reference at once

P r o c u r e m e n t A u t h o r i t y Seal and Stamp

Copy to Ref No dated

1 ) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated13082010

To

Sub Frozen Drugs-ordered to return to the Suppliers-reg(New drug policy 2009) Previous letterinvoice ref

The following products which were earlier frozen have now been ordered to return to suppliers directly with permission from the State drug Authority In this regard the suppliers have been instructed to take back their failed batch from the drug store of the stores Hence you are now instructed to return the following failed batches to the suppliers by obtaining proper authorization letter and acknowledgements from them

60

Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

Kindly acknowledge the receipt of this reference at once

Procurement Authority Seal and Stamp

Copy to

Ref No dated 2) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated14092010

To

Sub Frozen Drugs-ordered to return to the Suppliers- for issue of gate pass after verification reg(New drug policy 2009) Previous letterinvoice ref

The following products which were earlier frozen have now been released Hence they may be issued Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

Kindly acknowledge the receipt of this reference at once

Procurement Authority Seal and Stamp

Copy to

61

Ref No dated 3) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated

To

Sub Stop instruction-reg(New drug policy 2009) Previous letterinvoice ref

Until further instructions stop issue all the batches of the following item Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

You must intimate the available stock in the stores of the said batch Number to the Procurement Authority immediately Also retrieve quantity if already issued

Procurement Authority Seal and Stamp

Copy to

Ref No dated 4) HOD Procurement Office of

62

Appendix II Material handling in drug stores

Rack approx rates and dimensions

S No

Item Description UOM Approx Rate

1 MEDIUM DUTY RACK SIZE 2900 H X 3090 W X 800 D IN MM (AS PER SPECIFICATION)

Each 2499800

2 MEDIUM DUTY RACK ADD ON UNIT FOR SIZE OF SR NO2

Each 2243100

To locate a Box no 3 Rack no 14 in row3

SAMPLE OF RACK no Bin numbering -------------- S a y R K 1 4 R o w 3 B o x 1 6

SAMPLE LAYOUT of RACKS in a Drug Stores

63

Sample of another warehouse of distribution warehouse system

64

65

Slotted Angle racks with bin cards

66

Plastic Pallets

Plastic pallets ar e l i g h t w e i g h t l o w- c ost and exceed industry standards for strength and durability

NOTE A pallet has bottom deckboards (see sketch) A skid does not have bottom

67

deckboards

Battery Operated Stacker

Electric Stacker Ehh (Manual Push Type) - Manual drive - Lifting electrically with Battery 12 V 88 Ah - For loading and un-loading of trucks - Battery and loading device built - in - Battery charge gauge and charging current gauge Simple and Easy Operation - Lifting and Lowering electrically direct on steering arm - Pulling and pushing through steering arm - Electrically operated relief valve on hydraulic aggregate Safe Operation - Emergency Off Switch - Constant lowering speed - Protection through lowering brake valve - Overload protection through overload brake valve - Load chains covered preventing pinching threat - Electrically interlocking during loading process - Secured battery compartment opens upwardly - Stable buffering of the steering arm in upright position - In accordance with EWG Guidelines 89 240 - In accordance with VBG 12b Prevention of Accidents

Pallet Truck [ Top ]

68

----------------------------------------------------------------------------------------------------------------------------

For Transport Of All Goods On Pallets Safe and Easy Operation - through single hand operation Lifting moving

lowering with steering handle - neutral position of the hydraulic possible - overload pressure relief valve Long Service Life - robust co n s t r u c t i o n

- special hardened axles - hardened chromium plated ram - maintenance free Easy Maneuverability - through rubber steering rollers - nylon fork rollers

A h a n d t r o l l e y

69

Trolley with plastic bins for several items del ivery

70

Digital Weighing balances

Balances amp Scales EF Seriers Precision Electronic Balance

71

1

Ice lined Refrigerators

600 litres refrigrator

72

Walk in cooler

vacuum cleaner

73

satisfactory Samples of non perishable articles should be preserved safely under lock and key for comparison till the contract for supply is in force

( l ) R e a s o n s for rejecting the lowest tender and accepting the h i g h e r o n e s h o u l d a l w a y s b e r e c o r d e d in writing by the Purchase Committee

(m) No reason for rejecting the lowest tender need to be communicated to the tenderer

( n ) Every purchase order should clearly mention that the articles ordered shall be accepted subject to t h e approval of the Purchase Committee

( o ) Rules regarding deposition of earnest money and security money should be observed

( p ) For emergent purchases in public interest when there is no time to observe Store Purchase Rules purchases should be made up to Rs 2 5000 (refers to year -1 9 7 7 ) a t a t i m e A s f a r a s p o s s i b l e t h i s practice should be avoided

II PLACING OF ORDERS (a) For medicines and such other articles which the Medical Stores Depot Bombay

supplies order be placed with them at a specified time ( b ) For articles not on the Bombay Stores Depot Bombay lsquolimitedrsquo or lsquoopenrsquo

tenders be invited as the case may require It would be preferable to place orders on the manufactures or their authorized distributors

(c) For placing the orders on PSUrsquos Laghu Udyog Nigam or Organisations approved by the State government no tender needs to be invited

( d ) Price preference upto 10 is available to Small Scale Industries of this State only(not applicable as per New drug policy 2010 -1 1 )

III RECEIPT OF STORES All materials received should be examined counted measured or weighed as the

case may be when the delivery is taken The stores thus verified be may be immediately entered in the stock register Book under proper headings and this fact should be recorded on the body of the bill mentioning the page number of the Stock Book It should also be mentioned whether the quality and the quantity are correct as per the requirement Soon after the receipt each item be stamped with the initials of the institution

IV CUSTODY

(a)The head of the institution should ensure suitable accommodation for keeping the stores with a view to prevent losses through theft accident fraud or otherwise

(b) Separate Stock Accounts should be kept of-( i ) D e a d S t o c k-such as plantmachineryfurniture equipmentinstruments

etc (ii) Expendible items such as medicineslinenrubber goods etc (iii) Perishable articles

(c ) all recepts and issues in the stores stock registers should be on the authorityand under the signature of a respon sible officer deputed for the purpose

11

V ISSUE OF STORES (a) When materials are issued from stock the officer -i n ndashcharge should ensure that the indent is in proper proforma (Annexure A) and the person taking delivery is an authorized one (b) The issue vouchers (Annexure B) for articles should be prepared in triplicate by one single stroke of pen The first copy will remain with the records of the stores The second and third copies will go to supplies The second copy will be retained by the person receiving the supplies and the third copy will be returned by the receiver to the stores after making entries of hisher stock book page number etc against each item ( C ) E v e r y t i m e i s s u e b e r e c o r d e d i n t h e s t o c k b o o k o f t h e s t o r e s w i t h s i g n a t u r e s o f t h e O f f i ce r i n -charge

(d) Every issue made from the Central Stores to other institution should show cost of article preparation of Annual Stores Account at a later date

VI Maintenance of Stock Books (a) Stock book should be kept under the charge of a responsible person and should be

saved from loss and destruction ( b ) While making new entries in the main Stores Stock book cost of each item

should be entered though this need not be done in the case of registers in Wards Operation Theatre Out door etc

(c) There should b e n o o v e r-writing or interpolation or smudging of figures Any f i g u r e i f i t i s t o b e c o r r e c t e d s h o u l d b e c l e a n l y c u t a c r o s s a n d t h e n e w f i g u r e should be written by its side or below it under proper attestation

( d ) Stock books should always have a page count(each page be numbered) A certificate showing the number of pages be given on the first and the last page under the signatures of a Gazetted Officer

(e) Receipts issues and balances should be worked out for every item and attested regularly by the Offic er-i n -Charge of the Stores

(f) In the receipt column details regarding the size quality and any special features if t h e r e b e s h o u l d b e r e c o r d e d e g i n t h e c a s e o f A l m i r a h i t s s i z e a n d w h e t h e r i t i s of Steel or Wood

(g) In the Stock-book of library Edition and the ye a r o f p ublic a tion of th e book should always be mentioned

( h ) In case of medicines having an expiry date a list of such medicines be made out and should be checked every week Two months prior to the date of expiry if the s t o c k i s s t i l l f o u n d s u f f i c iently high intimation should be given to Directorate of Health

(i) N o r e m o v a l o f d e a d s t o c k s h o u l d b e m a d e f r o m t h e s t o c k ndash B o o k u n l e s s s o a u t h o r i z e d b y t h e c o m p e t e n t A u t h o r i t y

(j) While making a new Stock book and transferring the stocks therein it should ensured that the page number of the old stock book is shown in the new stock b o o k a n d s i m i l a r l y p a g e n u m b e r o f t h e n e w s t o c k b o o k i s m e n t i o n e d i n t h e o l d one This has to be done to facilitate cross checking whenever desired

( k ) T h e r e h a v e t o b e d i f f e r e n t s e t s o f proforma for dead stocks and for expendable items

Annexure ldquoCrdquo is for former and Annexure ldquoDrdquo for the latter varieties

12

VII PROCEDURE OF INDENTING FOR WARD amp OTHER SECTIONS OF THE INSTITUTION

(a) There has to be an Indent Book with every such section wh ich receives and issues medicinesequipment

( b ) The indent shall be prepared by the nurse Compounded -i n -c ha r g e of th e WardSection in te single copy on the Performa (Annexure A)

(c) The indent so prepared will be signed by the medical officer resident ndash i n c h arge or in his absence by a doctor senior to him but associated with the ward section

( d ) The indent shall then be signed by the head of the institution (Superintendent or the Civil Surgeon as the c a se ma y be ) o r b y his A ssista n t if th e la tte r is so authorized in writing

(e) The indent book is then presented to the main Store for effecting issue (f) The Store will then prepare issue vouchers (Annex B) in triplicate as directed

in Paragraph V (b) supra The supplies and the Indent Book are taken back by the Ward Section- i n - charge after signing the first copy of the issue voucher

(g) Te supplies after arriving in the WardSection shall be entered on the WardSection stock register which is prepared on a proforma (Annexure E) and page number of each entry be shown o n t h e 2 n d a n d 3r d copies of the Issue

voucher The 2 n d copy of the voucher is to be retained in a file in the wardsection but the 3r d c o p y s h o u l d b e r e t u r n e d t o t h e s t o r e b e f o r e s u b m i t t i n g a fresh indent The Store has to be maintain separate files of the 3 r d copies Wardsection-wise

VIIIHOW OFTEN TO INDENT

(a) A wardsection ndash i n -charge should work out an average weekly expenditure of each item and efforts be made to replenish the WardSection stocks every week

( b ) T h e M a i n s t o r e i n o r d e r t o a v o i d h e a v y rush of work should fix a day of issue for each major specialty T w o or th r e e minor spe c ia ltie s c a n be gr o upe d f o r one day

IX EMERGENT INDENT It is very likely for unforeseen reasons either the weekly indent of WardSection stock might get exhausted earlier or something which was not there in the lsquoweekly indentrsquo is required Under such circumstances an ldquoEmergent Indentrdquo could be made out in the usual manner but under the signature of the Unit-i n- chargeconsultant and it must be countersigned by the head of the institution (and not by his assistant) These supplies have also to be entered in the wardSection stock books like others

13

X HOW TO INDENT

(a) The ward Section -i n - c h a r g e s h o u l d e n s u r e t h a t t h e s t o c k s u n d e r t h e i r c h a r g e a r e not unnecessarily large and only a realistic quantity is indented once a week

( b ) The indent should not be made out in the names of the patients or by bed numbers The indent should be for the Wardsection as a whole

XI KEEPING OF RECORDS IN WARDS AND SECTIONS

(a) A set p r o f o r m a ( A n n e x u r e E ) s h o u l d b e u s e d i n t h e w a r d s e c t i o n f o r s h o w i n g u p receipts and issues Balance of expenditure for each item to be drawn out every morning by nursecompounder in charge before writing out the Indent or before restarting work The medica l O f f ic e r r e side nt in c ha r g e sh ould a tte st th e e ntr ie s after satisfying himself- by random checking at least once a week

( b ) To support the above mentioned expenditure the Bed head Tickets (treatment charts) are very important Each medicine prescribed should be legibly written indicating the total quantity prescribed if the medicine is to be deleted from treatment the fact should be mentioned as to how much of the drug was issued to the patient before switching on to another drug The suggestion is that a separate treatment card be maintained for each indoor patient ( Annexure ndash G) A summary s h o w i n g t h e t o t a l a m o u n t o f t h e p r o p r i e t a r y d r u g s c o n s u m e d b y t h e p a t i e n t d u r i n g is hospital stay be worked out and noted in the summary card

XII ACCOUNT ABILITY OF DRUGS BROUGHT BY THE PATIENT OR RECEIVED IN DONATION BY THE WARDSECTION _IN -C H A R G E

The drugs receoived from the non - governmental sources should be entered on the receipts side of the WardSection Sto c k b ook a n d issu e s to show n a s in th e o the r cases on the issues side

XII RSPONSIBILITY OF STORES AT VARIOUS LEVELS (a) The head of the institution shall be held responsible for non-observance of

rulesprocedures laid down by the Government ( b ) The Medical officerresident in charge of the stores and the store keeper shall be

held responsible for any irregularity found in the stores or for ignoring the ordered pattern of working It shall be the duty of the Medical officer Incharge of the Stores to occasionally check the WardSection Stock-b o o k s t o t a l l y t h e e n t r i e s made in the 3 r d copy of the Issue vouchers [as laid down under V (b)supra ]

(c) The Medical officerresident in charge of the WardSection shall be responsible for irregularities in indenting stocksfor maintaining stocks much in excess of the req uirement and for improper keeping of BED HEAD TICKETS (treatment chartsCards)

( d ) The NurseCompounder ndash i n -charge of the WardSection shall be responsible for shortages in stocks for putting up inflated indents and or for not taking into account medicines b rought by the patientson the WardSection stock-books Heshe shall also be held responsible for ensuring proper distribution of medicines to each and every patient under his her charge

XIV DISTRIBUTION OF MEDICINES FROM OUTDOOR DEPARTMENT (A) ( a ) T h e r e are proprietary and non -proprietary medicines (like mixtures ointments

and lotions) which are to be distributed gratis to patients 14

(b) The Outdoor incharge shall arrange to maintain a stock of common drugs (list of which shall be prepared by the Head of t he Institution) and arrange to replenish the stocks once a week as has been laid down for wards (c) No proprietary drugs shall be issued on the prescription of an intern ( d ) The Head of the institution shall make out a list of drugs which can be issued on

the prescription of a houseman from the Outdoor stock without the countersignature of any other authority

(e) The residents can prescribe any drug from Outdoor stock without the counter signature of any authority

(f) The Consultants can prescribe any drug to any ot h e r o u t e r p a t i e n t e v e n i f i t i s n o t s t o c k e d i n t h e o u t d o o r b u t t h i s s h a l l h a v e t o b e c o u n t e r s i g n e d b y t h e h e a d o f t h e institution for issue from The Main Store

(B) T h e p e r s o n i n c h a r g e o f t h e O u t d o o r m e d i c i n e s s t o c k s h a l l k e e p a r e c o r d o f t h e q u a n t i t y o f t he medicines issued to each patient and instead of writing the name and other details e may only put down the Registration number of the patient and the quantity issued

At the end of the day he must work out the total expenditure of eac item and draw it s balance

The Medical officer in charge of the Stores and the Head of the institution sould check these records at least once a week and affix is signature to confirm their inspection

(C ) No proprietary medicine shall be issued without a valid issue s l i p ( A n n e x u r e- F)

(a) For Housemen the slip would be of brown colour ( b ) For residentsDemonstrators it shall be of pink color (c) For consultants the issue slip should be white ( d ) All issue slips should be printed and pages serially numbered (e) T h e d o c t o r s t o w h o m s u c h i s s u e s l i p s w o u l d b e i s s u e d s h a l l b e h e l d

responsible for their sa f e ke e ping a n d th e y w ould e n su r e tha t th e se slip s would be printed and serially numbered

(f) The doctors prescription slips (for issue from hospitals) of proprietary drugs be prepared in du plicate with the help of carbon One copy should be given to patient for obtaining medicines from the Stores and the other would remain in the Doctors Prescription Slip book

(g) Every issue Slip should be signed and below the signatures a rubber s t a m p s h o w i ng name and designation be affixed The Store people would n o t h o n o u r s l i p u n l e s s t h e n a m e o f p r e s c r i b e r i s c l e a r a n d h i s a t t e s t e d signatures are available to stores

( h ) The Store Staff would file prescription slips of each doctor separately to facilitate the scrutiny at least once a month by the Head of the Institution Such a Scrutiny would reveal over prescribing of or injudicious use of drugs

(C) Proprietary medicines should not be issued for more than three days requirement at a time The only exceptions being cases for cancer pulmonary tuberculosis and leprosy In exceptional cases an officer not below the rank of a Consultant can prescribe for more than 3 days but after the countersignatures of the Head of the Institution

15

XV LOSS BREAKAGE DAMAGE ETC

(A) Any loss of public money departmental revenue of receipts stamps stores or other property held by or on behalf of the Government caused by defalcation or otherwise discovered in an office or institution should immediately be reported by the officer concerned to the head of department through his immediate superior as well as to the Accountant General if the loss exceeds Rs 20000(fig of 1977) (for Proforma see Annexure I)even when such loss has been made good by the party responsible for it Such reports must be submitted as soon as possible and soon after suspicion arises that there has been a loss they must not be delayed while detailed enquiries are made

When the matter has been fully investigated further and complete report should be submitted of the nature and extent of loss showing the errors or neglect rules by which such loss showing the errors or neglect of rules by which such loss was rendered possible and prospects of effecting such recovery

The s ubmission of such a repot does n o t d e b a r t h e l o c a l a u t h o r i t i e s t a k i n g f u r t h e r a c t i o n which may be deemed necessary like handing over the case to the police

Every Government servant should realize fully and clearly that he will be held personally responsible for any loss sustained by the government through fraud and negligence on is part and that will also be held personally responsible for any loss arising from fraud or negligence on the part of any other Government servant to extent to which it may be shown that he has contributed to loss by his own action or negligence

A s s o o n a s s h o r t a g e i n s t o c k o r l o s s i s d i s c o v e r e d a p a r t f r o m r e p o r t i n g t h e m a t t e r a responsible officer should be deputed to investigate the matter

W h e r e t h e r e i s n o l i k e l i h o o d o f a d e l i b e r a t e t h e f t b u t l o s s i s a result of neglect onlythe loss should be made good by the person on whose charge or custody the article lost remained

(B) As soon as damage or breakage of Government property is detected certain steps mentined under should be undertaken-

(a) A p r o m p t t h o ro u g h i n v e s t i g a t i o n i n t o t h e c a u s a t i o n o f b r e a k a g e o r d a m a g e s h o u l d be undertaken by the doctor-i n -charge of the WardSection or by the Head of the Institution

( b ) The investigating officer should draw conclusions as to whether the breakagedamage has been a result of-

(i) C a r e l e s s a n d n e g l i g e n t h a n d l i n g ( i i ) Unpredictable action of the patient for whom the equipment was

being used (iii) Accidental ( i v ) Manufacturing Defect

A report is then prepared in duplicate by person in charge of the article under question on the lsquobreakage and loss proformarsquo (See Annexure H)

16

These reports have to be signed by the investigating officer and are to be then submitted to competent authority for suitable action One copy which is returned is to be kept with the Stock Register In cases where the b r e a k a g e o r d a m a g e i s o f s u c h b i g g e r d e g r e e t h a t s atis factory repairs are not possible a n d if suc h b r e a k a ge o r da m a ge is o f su c h a de gr e e that satisfactory repairs are not possible and if such breakage or damage has been caused-

( i ) B y a G o v t s e r v a n t because of negligent or careless handling cost of the article should be recovered from him and credited to the treasury (ii)On account of reasons mentioned above that is un predictable action of the patient accidental or manufacturing defectthe article could be written offsubject to powers delegated to the concerned for such purpose

(C )Shortages detected during biannual physical verification of the Storeshave to be dealt in a similar manner

(D) it shall be at discretion of the competent authori ty (who is empowered to write off the loss) to reduce the amount of recovery upto 50 of the cost of article provided that before arriving at such a decisionhe has taken into account the following points (a) Normal life span of the article under questi on (b) Period for which it has been in use (c ) Condition of the article at the time of loss or damage and (d) Whether it was on account of careless or negligent act or not

XVI PROCEDURE FOR WRITING OFF STORES

(a) When any Stores become unserviceable otherwise than in ordinary course or by fair wear and tear their value should be treated as loss to the Government and in such cases cost should be recovered from the person responsible for his negligence

( b ) A s t r i c t w a t c h s h o u l d b e k e p t o n t h e m e d i c i n e s w h i ch bear an expiry date and if there is no likelihood of their being utilized locally intimation of the fact should be sent to Directorate of Health services and also to all o t h e r d i s t r i c t s s i m u l t a n e o u s l y s o t h a t t h e y c a n b e p u t t o u s e b e f o r e t h e expiry date In the event such a course is not followed and the Government i s p u t t o l o s s c o s t o f t h e m e d i c i n e i n q u e s t i o n s h a l l b e r e c o v e r e d f r o m t e defaulter

(c) For declaring articles as unserviceable a Committee of three members should be formed in each officeinstitution This Committee should examine each and every article brought before it and should record full reasons for condemning them and also say how the articles condemned have to be disposed of-whether by sale (by public auction) or otherwise

I f t he local Authority is not competent to write off the articles condemned by the Committee it should send the proposal to the higher authority for suitable a c t i o n

17

In Institutions where there is only one doctor a list of articles to be condemned should be p r e p a r e d a n d o r d e r s o n i t b e o b t a i n e d f r o m t h e inspecting authority during inspection

While preparing any list of articles for condemnation details regarding the date of purchase date of receipt period during which it remained in use usual life of the article and its purchase price should be noted against each item

( d ) The condemned articles should not be struck off the Stock Register till the competent authority sanctions its write ndashoff Details of Authority under which the article has been written off should be mentioned in stock register

XVII DISPOSAL OF WRITTEN OFF ARTICLES

Articles like linen should be torn into strips 10cm width so that they could be burnt or given to Government Jails for making carpets

Items like bed -pans bowlsurine po ts etc should be crushed and kept for auction

Brass utensils have also to be crushed to destroy their shape and could be either auctioned or after inviting rates from several dealers could be locally sold to highest bidder

In case when condemned ar ticles have to be sold by public auction they should be stored safely and the Government Auctioneer be intimated In case he expresses his inability to undertake the auction the officer should proceed with the auction departmentally The sale proceeds in either case should be credited to the Treasury as miscellaneous receipts under the Proper head of account

XVIII PHYSICAL VERIFICATION (a) The stocks held by officesinstitutions in various sections should be physically

verified twice a yearin the months o f April and October ( b ) Checking should be done by an officer other than te one who holds the charge of

Stores (c) Verification should be done in presence of officer holding the charge of Stores ( d ) All discrepancies found during the verification should be properly investigated

and accounted for

(j) Any excess detected during verification should be entered in the Stock book as Receipts with the remark ldquo Excess found on verificationrdquo

(ii)any shortage should be noted in issues column of lsquo Issuesrsquo described as lsquoshortage fou n d o n v e r i f i c a t i o n rsquo

XIX ANNUAL STORES ACCOUNT This account should be prepared according to the instruction issued from the department from time to time This should account for the outgoing financial year on the following lines -(a) Cost of the articles under various heads on the last day of the previous

year 18

( b ) Cost of the articles under the various Heads Received during the year (c) Cost of various articles written off during the year under review ( d ) Cost of the articles on the last day of the year or on the firs t d a y o f t h e

financial year following

19

Annexure A WardSection Indent Register No Issued on

Name of institution Page Folio No

Serial no Name of Article Quantity in Stock

Quantity required

Prepared by Approved by Recd by Note-Indenting Officer to sign and affix seal with name and

designation below the last item to avoid additions in one strokeno issues to be made by storesif Issue vouchers of

previous Indent has not been returned back by the WardSection

20

Annexure B Issue Voucher No (printed number)

Supplied to Wardsection Date

Indent no

Serial no Name of Article Quantity in Stock

Quantity required SB No

Stores-in MO Resident in Sign of charge charge WardSection

NurseCompounder Prepared by Recd Approved by by

Note-Indenting Officer to sign and affix seal with name and designation below the last item to avoid additions in one strokeno issues to be made by storesif Issue vouchers of previous Indent has not been

returned back 1st copy-Stores 2nd copy -Wardsection3rd copy-Tobe reurned to sores with Stock book entries

21

Annexure C

STOCK REGISTER FOR DEAD STOCKS

SERIAL NO DATE OF RECEIPT

Article with description

No of pieces Cost Details of

Bill Signature No Disposed

Date of disposal

Manner of Disposal

with Authority

Value realised Signature

1 2 3 4 5 6 7 8 9 10 11 12

P r e p a r e d B y C h e c k e d b y A p p r o v e d b y

Date Designation Name of Institution

22

Annexure D

STOCK REGISTER FOR EXPENDABLE ITEMS Name of article

Date

From where

received with cost

Quantity Signature To whom issued Quantity Balance Signature

1 2 3 4 5 6 7 8

23

Annexure E

Receipt amp Issue Register for WARDSSECTIONS (one or more pages as per requiremnt for each medicine)

NAME OF MEDICINE RECEIPT ISSUE

DATE Quantity In Stock

Date of

Issue

Issued toMention Bed no amp

quantity (in bracket) (For

Outdoor cases give Regd No)

Balance Signature

24

Annexure -F

OUTDOOR FREE MEDICINE SLIP In Duplicate

Name of Patient Registered No Date

Sr no Name of Medicine Quantity

Seal amp sign of doctor

25

Annexure-G

TREATMENT CARD

WARD NO

NAME OF PATIENT BED NO DATE amp TIME OF ADMISSION DATE amp TIME OF DISCHARGE

DATE MEDICINES PRESCRIBED SIGNATURE

26

ANNEXURE -H

PROFORMA FOR BREAKAGE amp LOSS

NAME OF OFFICEINSTITUTION DATE PLACE

SRNO NAME amp

DESCRIPTION OF ARTICLE

COST DATE OF PURCHASE

REASON CAUSE OF BREAKAGE

RECOMMENDATION OF INVESTIGATING AUTHORITY

Signature

Orders of the Competent Authority

Signature

27

Annexure ndash I Loss- Procedure for Reporting

1 The exact nature of the defalcation 2 The full extent of loss 3 The actual period covered by the defalcation 4 The defects in the negle c t o f r u le s by w hic h the loss was rendered possible

and circumstances which facilitated the defalcation 5 The names of the officials held personally or technically directly or

indirectly and wholly or partially responsible for the irregularity c o m m i t t e d i n t h e c a s e

6 Whether the c a s e a s b e e n J u d i c i a l l y t r i e d i n a c o u r t o r n o t i f s o c o p i e s ( i n duplicate) of the Judgment may please be furnished Copy of police report may also be furnished

7 The remedial measures adopted as safeguards against the losses hereafter 8 The prospects of re covery of the loss and he action taken to effect

recovery together with the amount recovered 9 Head of Account to which the Loss is debitable may be informed

Signature of Head of Office with seal

NoteA copy of this report is to be sent to AGMPThis is as per M P Finance Code Vol I

28

STORAGE AND STOCK MANAGEMENT

29

Foreword

The New Drug Policy 2009 is being implemented in the State of Madhya Pradesh

In order to have a proper procedure for Storage maintenance and expiry management of the drugs it is necessary to follow Good Storage Practices with Standard Modules for pharmacistStore keepers

Proper guidelines on Storage Practices can lead to better Stores and inventory upkeep with medicines being properly stored in racks with proper cleanliness and hygiene

This is a step towards storage maintenance and expiry management at the various stores in the state Looking forward to see that the heads of all health facilities take benefit from this module

D ir e c t o r M e d i c a l S e r v i c e s

30

INDEX

Sr No P a r t i c u l a r s P a g e

1 S T O R A G E A N D S T O C K M A N A G E M E N T 4

1 Quarantine and checking of stocks 11 Quarantine area 12 Checks to be carried out on new stocks

2 S t o r a g e 21 Need for proper storage 22 Different patterns of storage 23 Different means of storage 24 Temperatureclimatic conditions 25 Special storage of supplies 26 Storage and stability of medicines

3 Stock Control and Expiry Monitoring 31 Stock control 32 Stock rotation and expi r y m o n i t o r i n g

4 Other aspects of storage 41 Design of a storage area 42 Cleaning and maintenance 43 Product recalls 44 Returned goods

2 A p p e n d i x 1 Templates of letters for use if found not of Standard Quality [Frozen and expired goods ]

Frozen Drugs-ordered to return to the Suppliers-reg(New drug policy 2009)

Frozen Drugs-ordered to return to the Suppliers- for issue of gate pass after verification reg(New drug policy 2009) Stop instruction-reg(New drug policy

2009) Appendix II Material handling in drug stores

31

3 PROCUREMENT ndash Government Order Relating to

the Management of Stores

(Reproduced for reference material on basic

procedure in decentralized system followed by

Health facilities in 1977)

54

F L O W C H A R T S f o r a BI R D S E Y E V I E W o f

P R O C U R E M E N T

5 5

ACQUISITION OF STORES 6 1

PLACING OF ORDERS 6 2

RECEIPT OF STORES 6 2

CUSTODY 6 3

ISSUE OF STORES Maintenance of Stock Books

6 3

PROCEDURE OF INDENTING FOR WARD amp OTHER SECTIONS OF THE INSTITUTION

6 4

HOW OFTEN TO INDENT 6 5

EMERGENT INDENT 6 5

HOW TO INDENT 6 5

KEEPING OF RECORDS IN WARDS A N D S E C T I O N S

6 6

ACCOUNTABILITY OF DRUGS BROUGHT BY THE PATIENT OR RECEIVED IN DON A T I O N BY T H E WARDSECTION _IN - CHARGE

6 7

RESPONSIBILITY OF STORES AT VARIOUS LEVELS

6 7

DISTRIBUTION OF MEDICINES FROM OUTDOOR DEPARTMENT

6 7

LOSS BREAKAGE DAMAGE ETC 6 8

PROCEDURE FOR WRITING OFF STORES 6 9

DISPOSAL OF WRITTEN OFF ARTICLES 7 1

FORMATS TO BE USED 7 3 - 81

32

STORAGE AND STOCK MANAGEMENT The expiry periods of pharmaceutical products have meaning only if the products are stored under proper conditions otherwise products are likely to lose their potency before the actual date of expiry

A pharmacist is a vital link in the distribution chain for pharmaceutical products The medicinal products remain for a long period during the distribution cycle at the wholesaler and at retail pharmacies It is therefore very important to maintain proper storage conditions in these units

Every community pharmacy however large or s mall needs to store and manage its medicine stocks effectively There must be systems to ensure

middot bullbull Secure storage middot bullbull Clean and correct environmental conditions during storage middot bullbull Accurate and effective record keeping middot bullbull Effective stock rotation and expiry monitoring middot bullbull Effective fire and theft prevention middot bullbull Effective rodent pest control

For easier un derstanding this module has been divided into the following sections

1 Quarantine and checking of stocks 11 Quarantine area 12 Checks to be carried out on new stocks

2 S t o r a g e 21 Need for proper storage 22 Different patterns of storage 23 Different means of storage 24 Temperatureclimatic conditions 25 Special storage of supplies 26 Storage and stability of medicines

3 Stock Control and Expiry Monitoring 31 Stock control 3 2 S t o c k r o t a t i o n a n d e x p i r y m o n i t o r i n g

4 Other aspects of s t o r a g e 41 Design of a storage area 42 Cleaning and maintenance 43 Product recalls 44 Returned goods

33

1 QUARANTINE AND CHECKING OF STOCKS

11 Quarantine Area D r u g S t o r e pharmacies receive stoc k s f r o m su pplie r s a c c or d ing to pur c h a se o r d e r s T he stock that is received must be visually checked for quality and quantity The stocks must be kept in a separate area until the checking is done to avoid intermixing with existing stock This necessitates the presence of a separate area within the pharmacy w h e r e i n t h e storage and other checking of stocks can be performed This area is called the QUARANTINE AREA This area should be marked and identified adequately to distinguish it from other areas

The area may be marked using different means 1 ) A s m a l l board saying Quarantine on a separate table used exclusively if it is in the middle 2) A board on the wall if the table on which the quarantine stock is placed is against the wall

middot Stock received from wholesalers should be immediately transferred t o t h e Quarantine Area

middot In the Quarantine area the stock may be stored on racks shelves or in cupboards to prevent ingress of moisture dirt and other contaminants

middot Regular stocks from the pharmacy should not be left kept in the quarantine area Special care has to be taken in case of refrigerated medicines supplied by the suppliers so tha t the y do not remain in the quarantine area for long periods of time They should be immediately checked on receipt and transferred to areas for refrigerated storage s o a s to maintain the cold chain bull

Advantages of having a separate Quarantine Area middot Avoids cross mixing of newly arrived stock from existing stock till it is checked middot Lays stress on checking the quality of the stock received middot S to ck checking ensures t hat defective andor expired goods do not enter the storage areas

34

bullbull

bullbull

12 Checks to be carried out on new stock

Unpacking and checking stock

Supplies received should be unpacked and checked in the quarantine area Staff doing the checks should be adequatel y trained in what they have to check when stock arrives

Checking should be seen not simply as counting the units received but as a part of the quality assurance system bullThis should include middot Visually inspecting the packaging middot Checking the integrity of containers middot V erifying the completeness and leg ibility of la b e ls ( a ppr o ve d dr u g name strength any special storage instructions and expiry date)

bull

The expiry dat e should be checked to ensure that there is adequate shelf life remaining

Supplies should be individually checked using a checklist 35

Checklists

36

The wholesaler supplying the product should be notified immediately in case of any discrepancies ( and the details should be recorded in a register) and sent in a written format to the supplier It should include middot Missing boxes or cartons middot O p en tampered boxes or cartons middot Missing supplies middot Differences in the actual quantity and the quantity shown on the packing middot Additional medicines that had not been ordered but have been supplied middot D a m a g e d b r o k e n o r p oor quality medicines middot Any other discrepancies

The purchase invoices are an important aspect to be considered The invoiced documents should be signed and filed for reference as per the Drugs and Cosmetics Act and retained for at least 3years

If the wholesaler supplies medicines as an emergency without a bill or against a delivery challan

middot The supplies should be checked for integrity and inspected for damage middot The details of supplies received should be recorded middot The supplier should be asked t o send the bill as early as possible middot When the bill is received it should be checked against the details recorded and anomalies if any should be reported to the supplier

To keep a track of the received stock maintaining a S t o c k R e c o r d C a r d c a n b e very useful The entries in the stock record card can be made while checking the stock received STOCK BIN in the stores should have Stock record card

Maintaining a stock card for every product may not be very practical for a retail pharmacy however it could be maintained for costly medicines Nowadays it is much more practical and easier to maintain records using computers

The pharmacist should ensure that medicines manufacturedmarketed by a company are received only through an authorized distribution network of that company This is important to prevent spurious and counterfeit drugs from entering the pharmacy

37

2 STORAGE 21 The need for proper storage The storage of medicines and other products is an important requirement of Good Pharmacy Pr actice Appropriate storage of medicines is essential -

middot bullTo ensure that the potency is maintained middot bullTo prevent deteriorationspoilagedegradation middot bullTo ensuremaintain physical integrity

To ascertain that the quality and safety is maintained throughout their shelf life Storage requirements need to be considered on 2 aspects

a) Integrity of medicines Medicines should be stored in such a way so as to maintain their integrity and potency middot Maintain the right temperature required middot Protect from excessive humidity middot Keep medicines away from direct sunlight middot Protect from pests and rodents

b) Physical location middot Should be easy to locate middot Accessible middot Orderlysystematically placed

2 2 D i f f e r e n t p a t t e r n s o f s t o r a g e The pharmacist could follow any of the different patterns of storage The pattern of stora ge should be selected in such a way that it facilitates speedy and efficient dispensing of medicines

The pattern of storage could vary with each pharmacy experience usual practiceroutine of staff and the person-in charge and also depending on space av ailable turnover etc (i) The medicines could be stored c o m p a n y w i s e ie the medicines manufactured by one company should be grouped together and kept in one place Within each company shelfshelves the medicines may be placed in alphabetical order for easy and quick placement and removal Also bottles tubes boxes etc may be segregated within that shelf

38

(ii) The medicines may also be stored in a lphabe t ic al o r de r ie they are placed in order from left to right based on their name The first letter of the name is used to g r o u p t h e m e d i c i n e s t o g e t h e r a n d k e e p t h e m i n o n e l o c a t i o n I n s o m e p h a r m a c i e s a l l t h e strip packing are placed in drawers or boxes in alphabetical order each box or drawer containing strips of one particular alphabet This system ensures that the strips always remain e n c l o s e d i n t h e b o x e s d r a w e r s a n d a r e n o t e x p o s e d t o d u s t T h e d i s a d v a n t a g e i s that it might lead to mix -u p o f strips in the same drawer and it may cause a problem incase of similar looking strips in which case a wrong medicine may be dispensed Secondly cut strips lying around in the drawer may lose their identity if the batch n u m b e r andor expiry date is not seen on the cut portion of the strip

39

(iii) The medicines may be stored according to their therapeutic class ( e g a n t i b i o t i c s anti asthmatics or anti hypertensives) ie the medicines are kept together based on their pharmacological or therapeutic action

(iv) The medicines may be stockedsegregated according to dosage forms eg l i q u i d s (bottles) solid oral dosage forms eye drops rotacaps ointments etc all stored on separate shelves

Always Remember I Storage of prescription medicines should preferably be separate from OTC medicines OTC medicines especially those that a r e a d v e r t i s e d m a y b e d i s p l a y e d f o r c l i e n t s t o select or to ask questions about [OTC-O v e r t h e c o u n t e r ] II Storage according to temperatures is a must no matter which pattern of storage is followed Also within a particular storage area segregated storage may be maintained In a refrigerator for example medicines may be stored in trays racks and the freezer according to the temperature required

40

Whatever pattern of storage is selected all the personnel should ensure that middot The stocks are stored in an orderly manner middot The medicines are kept back in the same place from where they were removed middot All medicines are arranged neatly once in a while

middot The personnel should be careful while storing the medicines middot They should not throw the medicines haphazardly 23 Different means of storage

middot Within each temperature and security zone medicines must be stored so that they are easily accessible and protected against damage

middot Basic means of storage include shelves racks and drawers middot To prevent dust from entering the shelvesracks it is ideal to have glass

shutterssliding glass doors This can however be disadvantageous because accessibilityspeed is hampered in removing a product from the shelf because the glassshuttersliding glass has to be

41

opened m o v e d e v e r y t i m e a p r o d u c t h a s t o b e p i c k e d u p U s e o f a i r c o n d i t i o n e r s f o r t h e p h arm acy with a closed door at the e n t r a n c e o r a n a i r c u r t a i n c a n r e d u c e t h e d u s t problem In such cases the shelvesracks may be left o p e n

bull

middot Direct storage of cartons on the floor should be avoided because besides being an unhealthy practice the contents may also be damaged by moisture bull

middot Store medicines preferably in shelves with glass shutters for visibility middot Closed shelves further prevent dust from going in especially in India where most

pharmacies are located along busy roads middot Some medicines have to be refrigerated or stored in a cool or cold place Having a

refrigerator or two (as per the need of the pharmacy) is essential to store suc h medicines at temperatures mentioned on the label bull

42

Refrigeration middot All cold chain equipment should meet required standards middot Improvement in refrigeration technology has provided frost -free refrigerators

Pharmacists should opt for frost-free refrigerators as they are easy to maintain and protect printed packaging materials Conventional refrigerators may cause water falling from trays below the freezer on medicines stored in the refrigerator thus causing soggy labels

middot bull Frost-free refrigerators also provide separate and large compartments for the freezer portion (required for storing medicines needing sub-z e r o t e m p e r a t u r e ) and the main storage area with separate doors so that opening one door does not disturb the storage temperature in the other compartment

Care should be taken to keep the refrigerator on 24 hours a day It should not be switched off after working hours It is advisable to have an inverter connected to the refrigerator so that the refrigerator re mains working even when there is a power outage

middot The refrigerator door should be closed tightly middot The refrigerator door should not be left open for too long middot Space should be left between medicines stored in a refrigerator to allow air to

circulate middot The ref rigerator should be placed about an arms length away from the wall

This will increase air circulation thus not affecting the cooling within the refrigerator

middot Vaccines should not be stored on refrigerator door shelves as they are exposed to warmer temperatures each time the door is opened Vaccines should always be stored on the middle shelves of the refrigerator

middot Refrigerated medicines should not be left out of the refrigerator for more than a few minutes

43

middot Consumable products like juices energy drinks e t c s h o u l d n o t b e s t o r e d a l o n g with medicines in refrigerators If required they may be kept in a separate refrigerator

middot An adequate number of refrigerators should be planned to store the entire stocks requiring refrigerated storage

middot Adequate procedures should be followed for defrosting cleaning and maintenance of refrigerators

middot Icefreeze packs should be kept in the freezer compartment so that they can be used for transporting cold temperature medicines The packs can be given to clients along with the medicines requiring cold temperature storage so that the temperature is maintained till the client reaches home and can then put the medicines in a refrigerator) Freezer packs can also be used to keep medicines temporarily in case there is a power outage or refrigerator breakdown

Activity

Prepare a SOP (Standard operating procedure chart) for cleaning a refrigerator Discuss it with your staff finalize its maintenance once a month through AMC -A n n u a l Maintenance contract CMC - Comprehensive maintenance contract and put it up on the pharmacy refrigerator Put the Purchase Order details name of manufacturer Phone of Service Engineer and a register to login the Machine service and down timeService reports may be maintained properly

Refrigerator monitoring and maintenance

middot bullIt is important to carry out routine monitoring and maintenance of the refrigerators and to organize an effective repair system

middot bullThe temperature in the refrigerator must be monitored and recorded routinely at least once a day

middot Any breakdown must be reco rded including the period during which the medicines were exposed to uncontrolled temperatures Medicines may then be kept or discarded depending on the problem guidelines or the manufacturers advice

middot Cold chain monitor cards and devices in or on packages that change color or otherwise alert staff to potential damage assist in monitoring (These are likely to be introduced in India soon)

middot It is essential to have a contingency plan in place before a refrigerator breaks down An arrangement can be made to move the contents to a private refrigerator elsewhere in the community or to obtain a regular supply of ice packs until the defect is rectified

Put filled water bottles in the bottom half of the refrigerator door in order to provide cooling in the refri g e r a t o r w h e n t h e r e i s a p o w e r o u t a g e T h i s m i g h t t a k e c a r e o f t h e temperature when there is no current for a couple of hours If the power outage is expected to last for several hours special arrangements such as an inverter UPS have to be made to keep the refrigerator constantly running in the absence of electricity middot Defrost the refrigerator in case of excessive ice formation and preferably at regular

intervals Keep a record of the same

44

2 4 T e m p e r a t u r e c l i m a t i c c o n d i t i o n s

i) Temperature control middot The medicines in a pharmacy need to be stored at appropriate temperatures to

maintain their stability middot An air-conditioned environment where temperature can be controlled is

recommended for pharmacies Air conditioning offers the option of setting the t e m p e rature as per requirements

middot bullIt is ideal to have an air conditioner to maintain the temperature below 25 C as most medicines require storage below this temperature Secondly this temperature is pleasing to both the staff and the visiting customers too

middot In the absence of an air conditioner circulating fans may be used middot This need is felt even more in certain parts of India where temperatures soar above 45

C and some areas where it falls to sub zero temperatures In such cases temperature maintenance is essential to prevent deterioration of medicines due to unnecessary exposure to drastic temperature fluctuations

middot This need is felt even more in certain parts of India where temperatures soar above 45 C and some areas where it falls to sub zero temperat u r e s I n s u c h c a s e s temperature maintenance is essential to prevent deterioration of medicines due to unnecessary exposure to drastic temperature fluctuations

i i ) Humidity or moisture control Moisture or humidity can adversely affect the stability of me dicines such as tablets capsules powders

45

Gelatin capsules become soft and swell on absorption of moisture The drug content of tablets may undergo surface hydrolysis The presence of moisture may encourage the growth of microbes It is therefore essential to control humidity

To reduce the effect of humidity the following suggestions may be followed -middot Open the windows to allow air circulation Use a fan to circulate fresh (outside) air middot In humid climate a dehumidifier is useful for preventing mo i s t u r e d a m a g e ( i n t h e absence of an air conditioner) middot For bulk containers of tabletscapsules do not keep the container open for a long time and replace the lid or closure immediately after taking out the required number of medicines for dispensing middot Do not allow the medicines to touch the floor or the walls The walls may be damp and may cause moisture absorption damaging the product

middot Calibrated thermometers and manometers can be used to detect temperature and humidity in the pharmacy

middot Periodici t y of checking the temperature should be fixed middot The climatic conditions should be recorded and documented middot Temperature charts should be available for ready reference

Documentation is one of the core activities for achieving and maintaining quality It is one of the most essential components of validation Temperatures in various areas

46

including refrigerators should be recorded at a predetermined periodicity usually daily at the hottest time of the day and such documents should be preserved i i i ) Storage conditions A number of storage conditions are mentioned on the labels of medicinal products These conditions have to be properly interpreted and appropriately complied with

According to the Drugs and Cosmetics Rules 1945

1 The term cool place means a place having a temperature between 10 C and 25 C

2 The term cold place means a place having a temperature not exceeding 8 C In case of storage conditions for specific products please refer to Schedule P The Drugs and Cosmetic Rules 1 9 4 5

The Indian Pharmacopoeia specifies the following storage conditions -

Wherever the condition for storage is not specified medicines may be stored under normal temperature In a country like India however where normal temperatures soar to h i gh temperatures it is recommended that medicines be stored in a cool place

Activity Prepare a list of the storage requirements mentioned on the label of about 20 products in your pharmacy and check if the temperature is maintained

47

25 Special Storage o f s u p p l i e s If the product has no special instructions normal storage conditions apply This means storage in dry clean w e l l -ventilated premises at temperatures of +15 C to +25 C or depending on the climate up to +30 C (WHO1990) Storage instructions are product specific Different brands of the same generic drug may have different storage requirements as they may have different packaging or formulations It is essential to follow the product manufacturers storage instructions to the maximum extent possible Less stable medicines must be stored in specific conditions to maintain their quality or potency

The following products require special storage facilities

middot Products that must be kept frozen (usually vaccines and sera) middot Products sensitive to h eat an d r e q uir in g r e f r ig e r a tio n ( +2 C to +8 C) middot Products that have reduced shelf life at uncontrolled room temperature and need

mechanical ventilation or air conditioning middot Flammable products that require separate fireproof premises middot Products prone to theft o r m i s u s e

Products needing storage in a controlled environment -

The usable shelf life of the following products may be reduced if stored at uncontrolled humidity or at room temperature in hot climates -

middot Some injectables (eg adrenaline) Most injectable preparations are less stable than solid oral forms (tablets and capsules) Injectable preparations in solution are particularly unstable Many injections must be protected from light as well as heat

middot Intravenous fluids (particularly if packed in p lastic containers) middot Some suppositories pessaries creams and ointments These products may melt at

temperatures greater than 30 C Once this happens it is not advisable to use them because the active ingredient in the formula may get unevenly distributed

middot Products containing rubber latex cellulose or some plastics Condoms most sterile disposable medical devices and surgical products such as syringes needles and catheters require protection from excessive humidity and strong light and heat Any o f these conditions may make products brittle stained amp unusable Sterility cannot be assumed if packaging is damaged

In hot climates these products should be stored in the coolest place possible preferably with air conditioning or air circulation fans

48

Products needing freezing or refrigeration-middot Vaccines blood products and many other medicines lose potency if kept even for a

brief period at temperatures outside the recommended range For these products the cold chain must be maintained at every stage of the distribution system

middot Freezing is as damaging as high temperatures for some products including injectable contraceptives ergometrine insulin adrenaline and the DPT DT TT and Hepatitis B vaccines Such products therefore sho uld not be allowed to freeze (not be kept in the freezer compartment)

middot Short periods at room temperature (during transportation or local distribution for instance) may be acceptable for many products (such as ergometrine a n d i n s u l i n ) e v e n t h o u g h s u c h e x posure can to some extent reduce shelf life Other items such as vaccines should always be transported in cold boxes

Storage of insulin injections-

middot Insulin should always be stored in a refrigerator at the recommended temperature of 2 -8 C

middot Insulin should not be kept in the freezer compartment of the refrigerator middot Insulin should ideally be stored horizontally middot It should not be exposed to sunlight or excessive heat middot Insulin suspensions should not be used if the suspension cannot be properly

resuspended due to cake or clump formationbull

Controlled drugs -Narcotics (for example Pethidine injection morphine preparations) and other specified drugs that may be abused are governed by special legislation and regulations The following security measures are suggested in the pharmacy -middot A safe or reinforced double locked cabinet fitted with a light (preferably with a red

bulb) that comes on when the door is opened

49

middot A special register recording details of each receipt or issue with 2 signatures physi cal counting of medicines after each entry and signatures at handover takeover

middot Independent audit (by supervisors and drug inspectors)

Products prone to theft abuse or misuse -

Some medicinesproducts are particularly prone to theft abuse or misuse These include expensive medicines (eg insulin) certain antibiotics and products prone to abuse or misuse like psychotropics etc

Such medicinesproducts should be stored adequately They require stricter record keeping and more frequent stock taki ng than others Periodic audits should be carried out to check for consumption against actual recorded use (registers prescription records stock records etc) to expose any theft or misuse bull26 Storage and stability of medicines Medicines are not stab le indefinitely They are stable for a specific period of time sometimes for a brief period Poor storage conditions accelerate the drug degradation (decomposition) Temperature light and moisture are the most important contributing factors for drug instability It is important to identify and be aware of the potential for instability There is a need to comply with storage requirements to ensure quality medicines for patients It is also important to offer advice to patients too about appropriate storage o f medicines at home The dispensing label should state the storage condition required and be backed up by a verbal reminder especially where special storage is required bull

50

In case stability and storage problems are seen with formulations they should be reported immediately to the representative of the manufacturer and taken out of circulation till the stability problems have been resolved

The pharmacist can easily detect stability problems when products show change in appearance color odor settling of the product contents breaking of emulsions melting of creams oozing of contents from the containers and any such physical changes

3 STOCK CONTROL AND EXPIRY MONITORING 3 1 S t o c k C o n t r o l For economic reasons pharmacists do not like to have stock on their shelves for long periods of time The aim should always be to keep stock at a level that will just meet demand Normally most manufactured medicines have a long shelf life Even then it is essential that there is efficient stock rot ation so that the older stock is used first It is also a good practice to check the expiry date as an integral part of the dispensing process When short shelf life products are involved stock levels may have to be modified to prevent medicines regularl y expiring on the shelves

32 Stock rotation and expiry monitoring In order to avoid accumulation of expired and obsolete stock medicines should be stored and issued according to the following guidelines -middot The stock control system must record the ex p i r y d a t e a n d t h e d a t e o f r e c e i p t middot Stock must be stored so that earliest expiring batches are picked and issued first middot The First In First Out (FIFO) system - In this system the stock which is received

first is sold first This system however may not be useful for pharmacies because most of the stocks carry an expiry date For pharmacies the FEFO system is more practical

51

middot The First Expiry First Out (FEFO) system - In this system the stock having an earlier expiry is sold first The stock with longer shelf life should be placed farthest to the back (or at the bottom in case o f sta c k e d b oxe s) T h is is pa r tic u la r ly impor ta n t with products that have short shelf lives such as vaccines some vitamins antibiotics etc and reduces losses due to expiry

middot E x p i r y dates should be noted on the stock record upon receipt Stock nearing expiry should not be accepted unless it can be used before expiry

Computerization and expiry monitoring In the pharmacy computerization facilitates both checking stocks and expiry mo nitoring and helps-bullbullKeeping a check on products nearing expiry bullbullKeeping a check on non- moving and slow moving products bullbullTo facilitate the removal of medicines nearing expiry from shelves in time to send them back to the wholesaler or supplier

Periodic checking for expiry The expiry date for medicinal products is a critical aspect in pharmaceutical dispensing and due importance should be given to it Periodic checking for expiry of medicines will ensure that the patient will never receive products that have crossed their expiry date During periodical checking of expiry the personnel involved should remove medicines that are nearing expiry bullbullIn -house threshold periods should be set and followed for retrieval of such medicines from the shelves bullbullSuch medicines should be stored separately These should either be dispensed immediately (thus ensuring that they are used before the expiry date) o r t h e y s h o u l d b e returned to the suppliers bullbullA separate area should be designated (cupboard or shelf)marked[FROZEN ZONE] which is adequately marked EXPIRED GOODS- NOT FOR SALE to store all expired stocks FROZEN ZONE

52

Remember Expired medicines are a NATIONAL WASTE So stock only what you can sell Avoid expiries save precious medicines for the nation

Treatment and disposing of expired medicines bullbullProcedures need to be in place for the treatment of expired medicines bullbullThe expired medicines need to be collected and be sent back to the supplier or company for appropriate disposal bullbullRecords must be maintained for expired medicines and how they are disposed off bullbullIn case of medicines that are not returnable to suppliers procedures for disposal need to be followed by the pharmacy in conjunction with the FDA The following procedure can be followed if medicines cannot be returned to suppliers ( T h e b a s i c p h i l o s o p h y of appropriate disposal is to prevent their re- circulation and use) bullbullC u t t h e c o n t ainer in such a manner that the label is also cut In case of tablets and c a p s u l e s d e s t r o y them by disposing them in a bucket of water bullbullUse landfill procedures (deep burial into the ground as per stipulations of Medical Waste Disposal Act prevalent in the respective state) bullbullPour the liquids into the sink and wash away with sufficient quantity of water bullbullKeep a record of such disposal with full details of medicines destroyed Although these measures are usually adopted care has to be taken with such tr e a t m e n t a s studies have shown that flushing of medicines has resulted in tracessmall quantities of medicines being found in waterways and groundwater having potential health and environmental effects

4 O T H E R A S P E C T S 41 Design of storage areas The following important factors need to be considered in design of storage areas -middot The retail outlets in hot areas in summers should be air-conditioned Similarly in

a r e a s o f e x t r e m e c o l d t h e p r e m i s e s w o u l d r e q u i r e w a r m i n g e s p e c i a l l y i n w i n t e r s t o maintain cool temperatures The placement of air -conditioners and heating devices should be such that medicines are not directly exposed to the cold or heat

middot Due consideration should be given to storage requirements of formulations while designing shelves and cupboards in retail outlets Sufficient shelf height should be provided so that all liquid products can be stored vertically As far as possible the shelves should be covered with glass panels to protect medicines from dust and p r e v e n t r a p i d f l u c t u a t i o n s i n temperature

middot Medicines should be stored according to the storage instructions on the labels bullIt is ideal to have a door at the pharmacy entrance to prevent dust from coming in as well as reduceprevent cooled air from going out This may not however be considered feasiblepracticable by many pharmacy owners for fear that clients may not enter the pharmacy because the door may act as a barrier An air curtain is a good alternative to a door

middot There should be minimal direct sunlight falling on the products Particular consideration should be given to premises directly facing the sun

middot bullThe arrangement of lighting in the interior of the premises should also be in a manner that the lights are not focused on the products It has been shown that light causes not only chemical damage but also can catalyze physical changes like moisture uptak e by the products Care should be taken to ensure that only diffused light falls on them

53

middot As far as possible provision should be made for a temperature and humidity indicator device in a pharmacy These devices are now easily available

middot Stability studies o f m e d i c i n e s p a c k e d i n b l i s t e r s h a v e r e v e a l e d t h a t i f t h e s e a r e exposed to light they tend to absorb moisture It is therefore necessary to store them in suitable cartons so that the blisters are not exposed to light Pharmacists should do this even if the manufacturer has not provided cartons

middot Light and temperature sensitive products should not be stored on counters where the light is intense or direct and there is no protection from temperature and humidity

42 Cleaning and maintenance i) Cleaning of storage areas

The storage areas of the pharmacy should be cleaned periodically and cleanliness should be maintained at all times The Standard Operating Procedure for cleaning should be designed and followed accordingly Schedules for cleanups should be laid down and adequate cleaning equipment should be made available

Tips for maintaining cleanliness middot Provide clean pieces of cloth for wiping at various locations in the pharmacy

Replace with clean cloth at regular intervals middot Keep separate pieces of cloth for floors shelves and medicines middot Use a disinfectant andor soap solution to clean floors middot Ensure removal of dust and prevent accumulation of dirt middot Ensure removal of cobwebs middot Use a vacuum cleaner for cleaning areas not easily reachable middot T a k e c a r e t h at breakages are handled and cleared effectively middot Observe the factors leading to waste generation in the pharmacy and take appropriate

measures to tackle the problem middot Record all cleaning procedures performed and maintain all the documents required

For ex a m p l e -bullbullThe floor of the pharmacy may be swept with a broom and swabbed with soap water every morning bullbullThe floor may be swabbed with a disinfectant every week bullbullThe entire premises including shelves and cupboards may be cleaned with a cloth (to remove dust and to check for medicines approaching expiry date or expired medicines) every three months bullbullAll the steps followed should be r e c o r d e d

The floor shelves drawers have to be cleaned and a check should be kept on dust cobwebs spillages due to breakage etc It is therefore essential to have SOPs for cleaning laying down cleaning frequencies allotting responsibilities and maintaining a daily record in the logbook to document all these activities

54

While cleaning dust settled on dosage forms like bottles tubes etc should be removed Before dispensing the products should also be wiped to remove any dust settled during storage

For refrigerators bullbullDefrosting and cleaning should be done at regular intervals bullbullSwitch off the refrigerator while cleaning bullbullCleaning should be done quickly and stocks put back immediately

i i ) Pest control Pests are a serious problem in India where insects reptiles and rodents (eg cockroaches l i z a r d s r a t s s i l v e r f i s h (Deemak - in Hindi ) etc) may find access to the pharmacy storage areas Insects like ants and borer ants may often attack wood in the pharmacy causing d am ag e to shelves cupboardsPest c ontr o l in a p h a r m a c y c a n b e a d i f f i c u l t t a s k b u t t o avoid possible contamination and physical damage to stock it is necessary to keep pests out of the pharmacy premisesPest control measures should be implemented with proper p r e c a u t i o n s t a k i n g u t m o s t c a r e t o a v o i d contamination of medicines

55

Th e following pest control measures c a n be ta ke n f r om tim e to tim e -bullbullRat bait and traps can be placed at various locations bullbullInsecticutors can be used on a permanent basis bullbullInsecticidal sprays and repellants can be used from time to time

i i i ) Fire precautions

Combustible trash such as cartons boxes and other packing waste must not be allowed to accumulate in the store Waste should be deposited in appropriate waste bins and be d i s p o s e d o f f o n a d a i l y b a s i s

F i re detection and fire fighting equipment must be maintained and regularly inspected The pharmacy personnel should receive adequate training in fire fighting techniques and emergency actionFire prevention measures should include a prominently displayed ldquoNoSmokingrdquo sign careful handling and disposal of combustible waste materials and checking of electrical connections at regular intervals

iv) Security middot Doors shutters of the pharmacy should be strong and be fitted with secure locks middot Counters should be designed so that unauthorized personnelclients do not have

access to areas where prescription medicines are stored Access to such areas should be restricted to the pharmacy staff

middot All the pharmacy staff handling supplies should be accountable for their ac t i o n s

56

middot bullSpecial care must be taken in case of Schedule X and manufactured drugs (under NDPS Act) Such medicines should be kept under lock and key and the key should be kept with the Chief Pharmacist or i n h i s a b s e n c e t h e s e n i o r p h a r m a c i s t

v) Breakagespillage and damaged product Products that have been damagedspoiled during storage and handling spillages and broken glassware should be disposed off according to procedures laid down by the pharmacy Broken and damaged products s h o u l d b e p l a c e d i n a segregated area to be returned to the supplier

vi) Inspection Senior staff should inspect all pharmacy areas regularly The shelves and drawers should b e c h e c k e d d a i l y f o r signs of pests and dust Ceiling and walls should be checked for dirt and cobwebs Stock should be checked on a regular basis for deterioration due to climatic conditions

43 Product recalls Products found to be defective should be quickly recalled (withdrawn from the market) The instructions are generally issued either by the manufacturer or the regulatory agency The level of recall is determined by both the degree of risk and the extent of distribution of the product and in India is mainly directed at the distribution chain

On receiving the details of the defective substandard spurious batchbatches of a medicine to be recalled from the manufacturer or the stockist or the FDA the pharmacy should immediately check if the particular b a t c h i s i n s t o c k a n d i f s o s u s p e n d i t s s a l e immediately

Similarly if the regulatory authority in the country bans a particular medicine or FDC the pharmacy should immediately check and remove all the different brands of that particular medicine under consideration

The details of medicines and their batches to be recalled should be available in the q u a r a n t i n e a r e a w h e r e stocks are received and checked This is to ensure that such medicines do not come into the pharmacy

middot The pharmacy should develop SOPs for recall of medicines middot The pharmacy staff should be immediately informed about such medicines and

the details should be displayed in writing in a prominent place in the pharmacy middot Rapid action helps avoid unnecessary exposure to such medicines once the

problem has been d e t e c t e d middot The progress of the recall procedure in the pharmacy should be monitored every

few days to ensure complete compliance middot All stocks of the recalled products should be stored separately from the saleable

stock These can be stored in the expiry cupboard segregated from the expired goods and be appropriately labeled ldquoRecal l e d G o o d s - Not for Salerdquo

The supplier should be notified and asked to replace defective products middot All the details of the procedures followed should be duly recorded in a Recall

Register maintained specially for the purpose The register should include d etails such as -middot Date of the recall middot Nam e of the product

57

bullbull

middot Details of the product (name of manufacturer batch number expiry date) middot Nu m b er of units purchased sold a n d sto c k in ha nd middot Reason for recall middot Nam e of the supplier to whom produc ts w e r e returned along with the date and quantity middot Name and signature of the designated personnel carrying out the recall procedure and recording details middot Name and signature of the chief pharmacist verifying the recall procedures and recording details 4 4 Returned medicines

Medicines may be returned to the pharmacy by clients due to the following reasons -bull

bullbull Unused medicines bullbull Course not completed bullbull Therapy changed by doctor bullbull Side effects experienced by patient bull

bullbull DamagedDefective medicines bullbull Missing or defaced label bullbull Missing tablets in a stripblister bullbull Leakage in bottles bullbull Leakage in strips bull

bullbull Expired medicines

Appropriate SOPs should be framed and followed for their acceptancerefusal and disposal middot bull For unused medicines returned by clients the p harmacy personnel should verify

that these were purchased from their pharmacy They should then be checked for integrity of the packing the dosage form and the expiry date and verified with the client whether they were stored in appropriate conditions This again is at the discretion of each pharmacy

middot The damageddefective medicines returned to the pharmacy should be taken back and stored separately Existing stock of the same product should be checked for similar defects

middot Expired medicines should be accepted from clients at the discretion of the pharmacist and be immediately shifted to the expired goods cupboard These can be stored segregated from the pharmacys own expired goods and be appropriately labelled ldquoExpired Goods returned by clients- Not For Salerdquo

It is advisable not to accept returned medicines requiring cold chain storage (refrigeration) because it cannot be ensured that the cold chain was maintained when the medicines were in the hands of the patientclient middot Appropriate adjustments in t he stocks should be made for medicines

returnedexchanged to update the inventory middot The medicines should then be returned to the respective shelves middot A lsquoReturned Goodsrsquo register needs to be maintained to record all details of returned

medicines

R egister should include such details as-

58

middot N a m e o f t h e p a t i e n t middot Nam e of the product and quantity r e tu r n e d middot Product details such as the batch number and expiry date middot Condition in which received middot Reason for returning products middot Compensatory measures taken wi t h r e s p e c t t o c l i e n t middot Action taken with respect to product middot Name and signature of the personnel accepting the returned medicines and recording details middot Name and signature of the chief pharmacist verifying the recorded details

What the pharmacist would have learnt from this module The storage of medicines is a critical factor in the distribution cycle bullbull Stocks received by the pharmacy should be quarantined in a separate area and necessary checks s h o u ld be performed to ascertain the qua lity a nd quantity of stocks received bullbull Whatever pattern and means of storage used the products should be stored so as to maintain their potency and integrity bullbull Storage conditions should be monitored and maintained on a regular basis bullbull Optimum stock levels should be maintained and regularly monitored for expiry bullbull The design of storage areas should facilitate appropriate storage of medicines bullbull Cleanliness should be maintained in the pharmacy bullbull Adequate measures should be taken in case of returned medicines and recalled products

Optimum storage of medicines is mandatory whether at the distribution stage at the pharmacy or ultimately within the homes of patients The pharmacist has an important r o l e t o p l a y i n t h e s t o r a g e o f m e d i c i n e s i n m a i n t a i n i n g d r u g p o t ency and efficacy and thus facilitating optimum therapeutic benefits Good Pharmacy Practice - IPA -CDSCO - WHO Appendix I Quality Assurance Templates of letters for use if found not of Standard Quality [Frozen and expired goods ]

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated To Name of the Supplier with address

Sub Not of Standard Quality GoMP-Supply of Drugs and medicines-(Codename) Return of Stocks to the Suppliers-reg(New drug policy 2009) Previous letterinvoice ref Sl No Drug Code Drug name

Manufacturing date Expiry date

Supplier address

B a t c h n o

The above items of PO nodated was drawn by the Drug Inspector (Place) on (______________date) as a statutory sampling and declared ldquoNot of Standard

59

Qualityrdquo on -(______________date) by the Government Analyst for the following reasons

- ldquoThe product sample do not confirm to IP specification for (Drug codename with respect to the content of drugrdquo

- ldquoThe product has already been blacklisted by TNMSC on -(______________date) for the failure of (quantity) of batches of drug codenamerdquo

As per the clause of the te nde r d oc um e nt ldquo I f the sa mple s d o not c onf o r m to statutory standardsthe tenderer will be liable for relevant action under the existing laws and the entire stock in such batch should be taken back by the tenderer within a period of 30 days o f t h e r e c e i p t o f t h e l e t t e r f r o m t h e v e n u e

The stock shall be taken back at the expenses of the tendererthe Procurement Authority have the right to destroy such Not of Standard Quality if the tenderer does not take back the goods within the stipulated time

The Procuring Authority will arrange to destroy the Not of Standard Quality drugs within 90 days after the expiry of 30 days mentioned above without further notice and shall also collect demurrage charges calculated at the rate of 2 per week on the value of the drugs rejected till such destructionrdquo

Hence we regret to inform you that you will have to take back the stocks available of the abovesaid batch at your own cost from the drug stores where you have supplied the above batch

Kindly acknowledge the receipt of this reference at once

P r o c u r e m e n t A u t h o r i t y Seal and Stamp

Copy to Ref No dated

1 ) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated13082010

To

Sub Frozen Drugs-ordered to return to the Suppliers-reg(New drug policy 2009) Previous letterinvoice ref

The following products which were earlier frozen have now been ordered to return to suppliers directly with permission from the State drug Authority In this regard the suppliers have been instructed to take back their failed batch from the drug store of the stores Hence you are now instructed to return the following failed batches to the suppliers by obtaining proper authorization letter and acknowledgements from them

60

Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

Kindly acknowledge the receipt of this reference at once

Procurement Authority Seal and Stamp

Copy to

Ref No dated 2) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated14092010

To

Sub Frozen Drugs-ordered to return to the Suppliers- for issue of gate pass after verification reg(New drug policy 2009) Previous letterinvoice ref

The following products which were earlier frozen have now been released Hence they may be issued Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

Kindly acknowledge the receipt of this reference at once

Procurement Authority Seal and Stamp

Copy to

61

Ref No dated 3) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated

To

Sub Stop instruction-reg(New drug policy 2009) Previous letterinvoice ref

Until further instructions stop issue all the batches of the following item Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

You must intimate the available stock in the stores of the said batch Number to the Procurement Authority immediately Also retrieve quantity if already issued

Procurement Authority Seal and Stamp

Copy to

Ref No dated 4) HOD Procurement Office of

62

Appendix II Material handling in drug stores

Rack approx rates and dimensions

S No

Item Description UOM Approx Rate

1 MEDIUM DUTY RACK SIZE 2900 H X 3090 W X 800 D IN MM (AS PER SPECIFICATION)

Each 2499800

2 MEDIUM DUTY RACK ADD ON UNIT FOR SIZE OF SR NO2

Each 2243100

To locate a Box no 3 Rack no 14 in row3

SAMPLE OF RACK no Bin numbering -------------- S a y R K 1 4 R o w 3 B o x 1 6

SAMPLE LAYOUT of RACKS in a Drug Stores

63

Sample of another warehouse of distribution warehouse system

64

65

Slotted Angle racks with bin cards

66

Plastic Pallets

Plastic pallets ar e l i g h t w e i g h t l o w- c ost and exceed industry standards for strength and durability

NOTE A pallet has bottom deckboards (see sketch) A skid does not have bottom

67

deckboards

Battery Operated Stacker

Electric Stacker Ehh (Manual Push Type) - Manual drive - Lifting electrically with Battery 12 V 88 Ah - For loading and un-loading of trucks - Battery and loading device built - in - Battery charge gauge and charging current gauge Simple and Easy Operation - Lifting and Lowering electrically direct on steering arm - Pulling and pushing through steering arm - Electrically operated relief valve on hydraulic aggregate Safe Operation - Emergency Off Switch - Constant lowering speed - Protection through lowering brake valve - Overload protection through overload brake valve - Load chains covered preventing pinching threat - Electrically interlocking during loading process - Secured battery compartment opens upwardly - Stable buffering of the steering arm in upright position - In accordance with EWG Guidelines 89 240 - In accordance with VBG 12b Prevention of Accidents

Pallet Truck [ Top ]

68

----------------------------------------------------------------------------------------------------------------------------

For Transport Of All Goods On Pallets Safe and Easy Operation - through single hand operation Lifting moving

lowering with steering handle - neutral position of the hydraulic possible - overload pressure relief valve Long Service Life - robust co n s t r u c t i o n

- special hardened axles - hardened chromium plated ram - maintenance free Easy Maneuverability - through rubber steering rollers - nylon fork rollers

A h a n d t r o l l e y

69

Trolley with plastic bins for several items del ivery

70

Digital Weighing balances

Balances amp Scales EF Seriers Precision Electronic Balance

71

1

Ice lined Refrigerators

600 litres refrigrator

72

Walk in cooler

vacuum cleaner

73

V ISSUE OF STORES (a) When materials are issued from stock the officer -i n ndashcharge should ensure that the indent is in proper proforma (Annexure A) and the person taking delivery is an authorized one (b) The issue vouchers (Annexure B) for articles should be prepared in triplicate by one single stroke of pen The first copy will remain with the records of the stores The second and third copies will go to supplies The second copy will be retained by the person receiving the supplies and the third copy will be returned by the receiver to the stores after making entries of hisher stock book page number etc against each item ( C ) E v e r y t i m e i s s u e b e r e c o r d e d i n t h e s t o c k b o o k o f t h e s t o r e s w i t h s i g n a t u r e s o f t h e O f f i ce r i n -charge

(d) Every issue made from the Central Stores to other institution should show cost of article preparation of Annual Stores Account at a later date

VI Maintenance of Stock Books (a) Stock book should be kept under the charge of a responsible person and should be

saved from loss and destruction ( b ) While making new entries in the main Stores Stock book cost of each item

should be entered though this need not be done in the case of registers in Wards Operation Theatre Out door etc

(c) There should b e n o o v e r-writing or interpolation or smudging of figures Any f i g u r e i f i t i s t o b e c o r r e c t e d s h o u l d b e c l e a n l y c u t a c r o s s a n d t h e n e w f i g u r e should be written by its side or below it under proper attestation

( d ) Stock books should always have a page count(each page be numbered) A certificate showing the number of pages be given on the first and the last page under the signatures of a Gazetted Officer

(e) Receipts issues and balances should be worked out for every item and attested regularly by the Offic er-i n -Charge of the Stores

(f) In the receipt column details regarding the size quality and any special features if t h e r e b e s h o u l d b e r e c o r d e d e g i n t h e c a s e o f A l m i r a h i t s s i z e a n d w h e t h e r i t i s of Steel or Wood

(g) In the Stock-book of library Edition and the ye a r o f p ublic a tion of th e book should always be mentioned

( h ) In case of medicines having an expiry date a list of such medicines be made out and should be checked every week Two months prior to the date of expiry if the s t o c k i s s t i l l f o u n d s u f f i c iently high intimation should be given to Directorate of Health

(i) N o r e m o v a l o f d e a d s t o c k s h o u l d b e m a d e f r o m t h e s t o c k ndash B o o k u n l e s s s o a u t h o r i z e d b y t h e c o m p e t e n t A u t h o r i t y

(j) While making a new Stock book and transferring the stocks therein it should ensured that the page number of the old stock book is shown in the new stock b o o k a n d s i m i l a r l y p a g e n u m b e r o f t h e n e w s t o c k b o o k i s m e n t i o n e d i n t h e o l d one This has to be done to facilitate cross checking whenever desired

( k ) T h e r e h a v e t o b e d i f f e r e n t s e t s o f proforma for dead stocks and for expendable items

Annexure ldquoCrdquo is for former and Annexure ldquoDrdquo for the latter varieties

12

VII PROCEDURE OF INDENTING FOR WARD amp OTHER SECTIONS OF THE INSTITUTION

(a) There has to be an Indent Book with every such section wh ich receives and issues medicinesequipment

( b ) The indent shall be prepared by the nurse Compounded -i n -c ha r g e of th e WardSection in te single copy on the Performa (Annexure A)

(c) The indent so prepared will be signed by the medical officer resident ndash i n c h arge or in his absence by a doctor senior to him but associated with the ward section

( d ) The indent shall then be signed by the head of the institution (Superintendent or the Civil Surgeon as the c a se ma y be ) o r b y his A ssista n t if th e la tte r is so authorized in writing

(e) The indent book is then presented to the main Store for effecting issue (f) The Store will then prepare issue vouchers (Annex B) in triplicate as directed

in Paragraph V (b) supra The supplies and the Indent Book are taken back by the Ward Section- i n - charge after signing the first copy of the issue voucher

(g) Te supplies after arriving in the WardSection shall be entered on the WardSection stock register which is prepared on a proforma (Annexure E) and page number of each entry be shown o n t h e 2 n d a n d 3r d copies of the Issue

voucher The 2 n d copy of the voucher is to be retained in a file in the wardsection but the 3r d c o p y s h o u l d b e r e t u r n e d t o t h e s t o r e b e f o r e s u b m i t t i n g a fresh indent The Store has to be maintain separate files of the 3 r d copies Wardsection-wise

VIIIHOW OFTEN TO INDENT

(a) A wardsection ndash i n -charge should work out an average weekly expenditure of each item and efforts be made to replenish the WardSection stocks every week

( b ) T h e M a i n s t o r e i n o r d e r t o a v o i d h e a v y rush of work should fix a day of issue for each major specialty T w o or th r e e minor spe c ia ltie s c a n be gr o upe d f o r one day

IX EMERGENT INDENT It is very likely for unforeseen reasons either the weekly indent of WardSection stock might get exhausted earlier or something which was not there in the lsquoweekly indentrsquo is required Under such circumstances an ldquoEmergent Indentrdquo could be made out in the usual manner but under the signature of the Unit-i n- chargeconsultant and it must be countersigned by the head of the institution (and not by his assistant) These supplies have also to be entered in the wardSection stock books like others

13

X HOW TO INDENT

(a) The ward Section -i n - c h a r g e s h o u l d e n s u r e t h a t t h e s t o c k s u n d e r t h e i r c h a r g e a r e not unnecessarily large and only a realistic quantity is indented once a week

( b ) The indent should not be made out in the names of the patients or by bed numbers The indent should be for the Wardsection as a whole

XI KEEPING OF RECORDS IN WARDS AND SECTIONS

(a) A set p r o f o r m a ( A n n e x u r e E ) s h o u l d b e u s e d i n t h e w a r d s e c t i o n f o r s h o w i n g u p receipts and issues Balance of expenditure for each item to be drawn out every morning by nursecompounder in charge before writing out the Indent or before restarting work The medica l O f f ic e r r e side nt in c ha r g e sh ould a tte st th e e ntr ie s after satisfying himself- by random checking at least once a week

( b ) To support the above mentioned expenditure the Bed head Tickets (treatment charts) are very important Each medicine prescribed should be legibly written indicating the total quantity prescribed if the medicine is to be deleted from treatment the fact should be mentioned as to how much of the drug was issued to the patient before switching on to another drug The suggestion is that a separate treatment card be maintained for each indoor patient ( Annexure ndash G) A summary s h o w i n g t h e t o t a l a m o u n t o f t h e p r o p r i e t a r y d r u g s c o n s u m e d b y t h e p a t i e n t d u r i n g is hospital stay be worked out and noted in the summary card

XII ACCOUNT ABILITY OF DRUGS BROUGHT BY THE PATIENT OR RECEIVED IN DONATION BY THE WARDSECTION _IN -C H A R G E

The drugs receoived from the non - governmental sources should be entered on the receipts side of the WardSection Sto c k b ook a n d issu e s to show n a s in th e o the r cases on the issues side

XII RSPONSIBILITY OF STORES AT VARIOUS LEVELS (a) The head of the institution shall be held responsible for non-observance of

rulesprocedures laid down by the Government ( b ) The Medical officerresident in charge of the stores and the store keeper shall be

held responsible for any irregularity found in the stores or for ignoring the ordered pattern of working It shall be the duty of the Medical officer Incharge of the Stores to occasionally check the WardSection Stock-b o o k s t o t a l l y t h e e n t r i e s made in the 3 r d copy of the Issue vouchers [as laid down under V (b)supra ]

(c) The Medical officerresident in charge of the WardSection shall be responsible for irregularities in indenting stocksfor maintaining stocks much in excess of the req uirement and for improper keeping of BED HEAD TICKETS (treatment chartsCards)

( d ) The NurseCompounder ndash i n -charge of the WardSection shall be responsible for shortages in stocks for putting up inflated indents and or for not taking into account medicines b rought by the patientson the WardSection stock-books Heshe shall also be held responsible for ensuring proper distribution of medicines to each and every patient under his her charge

XIV DISTRIBUTION OF MEDICINES FROM OUTDOOR DEPARTMENT (A) ( a ) T h e r e are proprietary and non -proprietary medicines (like mixtures ointments

and lotions) which are to be distributed gratis to patients 14

(b) The Outdoor incharge shall arrange to maintain a stock of common drugs (list of which shall be prepared by the Head of t he Institution) and arrange to replenish the stocks once a week as has been laid down for wards (c) No proprietary drugs shall be issued on the prescription of an intern ( d ) The Head of the institution shall make out a list of drugs which can be issued on

the prescription of a houseman from the Outdoor stock without the countersignature of any other authority

(e) The residents can prescribe any drug from Outdoor stock without the counter signature of any authority

(f) The Consultants can prescribe any drug to any ot h e r o u t e r p a t i e n t e v e n i f i t i s n o t s t o c k e d i n t h e o u t d o o r b u t t h i s s h a l l h a v e t o b e c o u n t e r s i g n e d b y t h e h e a d o f t h e institution for issue from The Main Store

(B) T h e p e r s o n i n c h a r g e o f t h e O u t d o o r m e d i c i n e s s t o c k s h a l l k e e p a r e c o r d o f t h e q u a n t i t y o f t he medicines issued to each patient and instead of writing the name and other details e may only put down the Registration number of the patient and the quantity issued

At the end of the day he must work out the total expenditure of eac item and draw it s balance

The Medical officer in charge of the Stores and the Head of the institution sould check these records at least once a week and affix is signature to confirm their inspection

(C ) No proprietary medicine shall be issued without a valid issue s l i p ( A n n e x u r e- F)

(a) For Housemen the slip would be of brown colour ( b ) For residentsDemonstrators it shall be of pink color (c) For consultants the issue slip should be white ( d ) All issue slips should be printed and pages serially numbered (e) T h e d o c t o r s t o w h o m s u c h i s s u e s l i p s w o u l d b e i s s u e d s h a l l b e h e l d

responsible for their sa f e ke e ping a n d th e y w ould e n su r e tha t th e se slip s would be printed and serially numbered

(f) The doctors prescription slips (for issue from hospitals) of proprietary drugs be prepared in du plicate with the help of carbon One copy should be given to patient for obtaining medicines from the Stores and the other would remain in the Doctors Prescription Slip book

(g) Every issue Slip should be signed and below the signatures a rubber s t a m p s h o w i ng name and designation be affixed The Store people would n o t h o n o u r s l i p u n l e s s t h e n a m e o f p r e s c r i b e r i s c l e a r a n d h i s a t t e s t e d signatures are available to stores

( h ) The Store Staff would file prescription slips of each doctor separately to facilitate the scrutiny at least once a month by the Head of the Institution Such a Scrutiny would reveal over prescribing of or injudicious use of drugs

(C) Proprietary medicines should not be issued for more than three days requirement at a time The only exceptions being cases for cancer pulmonary tuberculosis and leprosy In exceptional cases an officer not below the rank of a Consultant can prescribe for more than 3 days but after the countersignatures of the Head of the Institution

15

XV LOSS BREAKAGE DAMAGE ETC

(A) Any loss of public money departmental revenue of receipts stamps stores or other property held by or on behalf of the Government caused by defalcation or otherwise discovered in an office or institution should immediately be reported by the officer concerned to the head of department through his immediate superior as well as to the Accountant General if the loss exceeds Rs 20000(fig of 1977) (for Proforma see Annexure I)even when such loss has been made good by the party responsible for it Such reports must be submitted as soon as possible and soon after suspicion arises that there has been a loss they must not be delayed while detailed enquiries are made

When the matter has been fully investigated further and complete report should be submitted of the nature and extent of loss showing the errors or neglect rules by which such loss showing the errors or neglect of rules by which such loss was rendered possible and prospects of effecting such recovery

The s ubmission of such a repot does n o t d e b a r t h e l o c a l a u t h o r i t i e s t a k i n g f u r t h e r a c t i o n which may be deemed necessary like handing over the case to the police

Every Government servant should realize fully and clearly that he will be held personally responsible for any loss sustained by the government through fraud and negligence on is part and that will also be held personally responsible for any loss arising from fraud or negligence on the part of any other Government servant to extent to which it may be shown that he has contributed to loss by his own action or negligence

A s s o o n a s s h o r t a g e i n s t o c k o r l o s s i s d i s c o v e r e d a p a r t f r o m r e p o r t i n g t h e m a t t e r a responsible officer should be deputed to investigate the matter

W h e r e t h e r e i s n o l i k e l i h o o d o f a d e l i b e r a t e t h e f t b u t l o s s i s a result of neglect onlythe loss should be made good by the person on whose charge or custody the article lost remained

(B) As soon as damage or breakage of Government property is detected certain steps mentined under should be undertaken-

(a) A p r o m p t t h o ro u g h i n v e s t i g a t i o n i n t o t h e c a u s a t i o n o f b r e a k a g e o r d a m a g e s h o u l d be undertaken by the doctor-i n -charge of the WardSection or by the Head of the Institution

( b ) The investigating officer should draw conclusions as to whether the breakagedamage has been a result of-

(i) C a r e l e s s a n d n e g l i g e n t h a n d l i n g ( i i ) Unpredictable action of the patient for whom the equipment was

being used (iii) Accidental ( i v ) Manufacturing Defect

A report is then prepared in duplicate by person in charge of the article under question on the lsquobreakage and loss proformarsquo (See Annexure H)

16

These reports have to be signed by the investigating officer and are to be then submitted to competent authority for suitable action One copy which is returned is to be kept with the Stock Register In cases where the b r e a k a g e o r d a m a g e i s o f s u c h b i g g e r d e g r e e t h a t s atis factory repairs are not possible a n d if suc h b r e a k a ge o r da m a ge is o f su c h a de gr e e that satisfactory repairs are not possible and if such breakage or damage has been caused-

( i ) B y a G o v t s e r v a n t because of negligent or careless handling cost of the article should be recovered from him and credited to the treasury (ii)On account of reasons mentioned above that is un predictable action of the patient accidental or manufacturing defectthe article could be written offsubject to powers delegated to the concerned for such purpose

(C )Shortages detected during biannual physical verification of the Storeshave to be dealt in a similar manner

(D) it shall be at discretion of the competent authori ty (who is empowered to write off the loss) to reduce the amount of recovery upto 50 of the cost of article provided that before arriving at such a decisionhe has taken into account the following points (a) Normal life span of the article under questi on (b) Period for which it has been in use (c ) Condition of the article at the time of loss or damage and (d) Whether it was on account of careless or negligent act or not

XVI PROCEDURE FOR WRITING OFF STORES

(a) When any Stores become unserviceable otherwise than in ordinary course or by fair wear and tear their value should be treated as loss to the Government and in such cases cost should be recovered from the person responsible for his negligence

( b ) A s t r i c t w a t c h s h o u l d b e k e p t o n t h e m e d i c i n e s w h i ch bear an expiry date and if there is no likelihood of their being utilized locally intimation of the fact should be sent to Directorate of Health services and also to all o t h e r d i s t r i c t s s i m u l t a n e o u s l y s o t h a t t h e y c a n b e p u t t o u s e b e f o r e t h e expiry date In the event such a course is not followed and the Government i s p u t t o l o s s c o s t o f t h e m e d i c i n e i n q u e s t i o n s h a l l b e r e c o v e r e d f r o m t e defaulter

(c) For declaring articles as unserviceable a Committee of three members should be formed in each officeinstitution This Committee should examine each and every article brought before it and should record full reasons for condemning them and also say how the articles condemned have to be disposed of-whether by sale (by public auction) or otherwise

I f t he local Authority is not competent to write off the articles condemned by the Committee it should send the proposal to the higher authority for suitable a c t i o n

17

In Institutions where there is only one doctor a list of articles to be condemned should be p r e p a r e d a n d o r d e r s o n i t b e o b t a i n e d f r o m t h e inspecting authority during inspection

While preparing any list of articles for condemnation details regarding the date of purchase date of receipt period during which it remained in use usual life of the article and its purchase price should be noted against each item

( d ) The condemned articles should not be struck off the Stock Register till the competent authority sanctions its write ndashoff Details of Authority under which the article has been written off should be mentioned in stock register

XVII DISPOSAL OF WRITTEN OFF ARTICLES

Articles like linen should be torn into strips 10cm width so that they could be burnt or given to Government Jails for making carpets

Items like bed -pans bowlsurine po ts etc should be crushed and kept for auction

Brass utensils have also to be crushed to destroy their shape and could be either auctioned or after inviting rates from several dealers could be locally sold to highest bidder

In case when condemned ar ticles have to be sold by public auction they should be stored safely and the Government Auctioneer be intimated In case he expresses his inability to undertake the auction the officer should proceed with the auction departmentally The sale proceeds in either case should be credited to the Treasury as miscellaneous receipts under the Proper head of account

XVIII PHYSICAL VERIFICATION (a) The stocks held by officesinstitutions in various sections should be physically

verified twice a yearin the months o f April and October ( b ) Checking should be done by an officer other than te one who holds the charge of

Stores (c) Verification should be done in presence of officer holding the charge of Stores ( d ) All discrepancies found during the verification should be properly investigated

and accounted for

(j) Any excess detected during verification should be entered in the Stock book as Receipts with the remark ldquo Excess found on verificationrdquo

(ii)any shortage should be noted in issues column of lsquo Issuesrsquo described as lsquoshortage fou n d o n v e r i f i c a t i o n rsquo

XIX ANNUAL STORES ACCOUNT This account should be prepared according to the instruction issued from the department from time to time This should account for the outgoing financial year on the following lines -(a) Cost of the articles under various heads on the last day of the previous

year 18

( b ) Cost of the articles under the various Heads Received during the year (c) Cost of various articles written off during the year under review ( d ) Cost of the articles on the last day of the year or on the firs t d a y o f t h e

financial year following

19

Annexure A WardSection Indent Register No Issued on

Name of institution Page Folio No

Serial no Name of Article Quantity in Stock

Quantity required

Prepared by Approved by Recd by Note-Indenting Officer to sign and affix seal with name and

designation below the last item to avoid additions in one strokeno issues to be made by storesif Issue vouchers of

previous Indent has not been returned back by the WardSection

20

Annexure B Issue Voucher No (printed number)

Supplied to Wardsection Date

Indent no

Serial no Name of Article Quantity in Stock

Quantity required SB No

Stores-in MO Resident in Sign of charge charge WardSection

NurseCompounder Prepared by Recd Approved by by

Note-Indenting Officer to sign and affix seal with name and designation below the last item to avoid additions in one strokeno issues to be made by storesif Issue vouchers of previous Indent has not been

returned back 1st copy-Stores 2nd copy -Wardsection3rd copy-Tobe reurned to sores with Stock book entries

21

Annexure C

STOCK REGISTER FOR DEAD STOCKS

SERIAL NO DATE OF RECEIPT

Article with description

No of pieces Cost Details of

Bill Signature No Disposed

Date of disposal

Manner of Disposal

with Authority

Value realised Signature

1 2 3 4 5 6 7 8 9 10 11 12

P r e p a r e d B y C h e c k e d b y A p p r o v e d b y

Date Designation Name of Institution

22

Annexure D

STOCK REGISTER FOR EXPENDABLE ITEMS Name of article

Date

From where

received with cost

Quantity Signature To whom issued Quantity Balance Signature

1 2 3 4 5 6 7 8

23

Annexure E

Receipt amp Issue Register for WARDSSECTIONS (one or more pages as per requiremnt for each medicine)

NAME OF MEDICINE RECEIPT ISSUE

DATE Quantity In Stock

Date of

Issue

Issued toMention Bed no amp

quantity (in bracket) (For

Outdoor cases give Regd No)

Balance Signature

24

Annexure -F

OUTDOOR FREE MEDICINE SLIP In Duplicate

Name of Patient Registered No Date

Sr no Name of Medicine Quantity

Seal amp sign of doctor

25

Annexure-G

TREATMENT CARD

WARD NO

NAME OF PATIENT BED NO DATE amp TIME OF ADMISSION DATE amp TIME OF DISCHARGE

DATE MEDICINES PRESCRIBED SIGNATURE

26

ANNEXURE -H

PROFORMA FOR BREAKAGE amp LOSS

NAME OF OFFICEINSTITUTION DATE PLACE

SRNO NAME amp

DESCRIPTION OF ARTICLE

COST DATE OF PURCHASE

REASON CAUSE OF BREAKAGE

RECOMMENDATION OF INVESTIGATING AUTHORITY

Signature

Orders of the Competent Authority

Signature

27

Annexure ndash I Loss- Procedure for Reporting

1 The exact nature of the defalcation 2 The full extent of loss 3 The actual period covered by the defalcation 4 The defects in the negle c t o f r u le s by w hic h the loss was rendered possible

and circumstances which facilitated the defalcation 5 The names of the officials held personally or technically directly or

indirectly and wholly or partially responsible for the irregularity c o m m i t t e d i n t h e c a s e

6 Whether the c a s e a s b e e n J u d i c i a l l y t r i e d i n a c o u r t o r n o t i f s o c o p i e s ( i n duplicate) of the Judgment may please be furnished Copy of police report may also be furnished

7 The remedial measures adopted as safeguards against the losses hereafter 8 The prospects of re covery of the loss and he action taken to effect

recovery together with the amount recovered 9 Head of Account to which the Loss is debitable may be informed

Signature of Head of Office with seal

NoteA copy of this report is to be sent to AGMPThis is as per M P Finance Code Vol I

28

STORAGE AND STOCK MANAGEMENT

29

Foreword

The New Drug Policy 2009 is being implemented in the State of Madhya Pradesh

In order to have a proper procedure for Storage maintenance and expiry management of the drugs it is necessary to follow Good Storage Practices with Standard Modules for pharmacistStore keepers

Proper guidelines on Storage Practices can lead to better Stores and inventory upkeep with medicines being properly stored in racks with proper cleanliness and hygiene

This is a step towards storage maintenance and expiry management at the various stores in the state Looking forward to see that the heads of all health facilities take benefit from this module

D ir e c t o r M e d i c a l S e r v i c e s

30

INDEX

Sr No P a r t i c u l a r s P a g e

1 S T O R A G E A N D S T O C K M A N A G E M E N T 4

1 Quarantine and checking of stocks 11 Quarantine area 12 Checks to be carried out on new stocks

2 S t o r a g e 21 Need for proper storage 22 Different patterns of storage 23 Different means of storage 24 Temperatureclimatic conditions 25 Special storage of supplies 26 Storage and stability of medicines

3 Stock Control and Expiry Monitoring 31 Stock control 32 Stock rotation and expi r y m o n i t o r i n g

4 Other aspects of storage 41 Design of a storage area 42 Cleaning and maintenance 43 Product recalls 44 Returned goods

2 A p p e n d i x 1 Templates of letters for use if found not of Standard Quality [Frozen and expired goods ]

Frozen Drugs-ordered to return to the Suppliers-reg(New drug policy 2009)

Frozen Drugs-ordered to return to the Suppliers- for issue of gate pass after verification reg(New drug policy 2009) Stop instruction-reg(New drug policy

2009) Appendix II Material handling in drug stores

31

3 PROCUREMENT ndash Government Order Relating to

the Management of Stores

(Reproduced for reference material on basic

procedure in decentralized system followed by

Health facilities in 1977)

54

F L O W C H A R T S f o r a BI R D S E Y E V I E W o f

P R O C U R E M E N T

5 5

ACQUISITION OF STORES 6 1

PLACING OF ORDERS 6 2

RECEIPT OF STORES 6 2

CUSTODY 6 3

ISSUE OF STORES Maintenance of Stock Books

6 3

PROCEDURE OF INDENTING FOR WARD amp OTHER SECTIONS OF THE INSTITUTION

6 4

HOW OFTEN TO INDENT 6 5

EMERGENT INDENT 6 5

HOW TO INDENT 6 5

KEEPING OF RECORDS IN WARDS A N D S E C T I O N S

6 6

ACCOUNTABILITY OF DRUGS BROUGHT BY THE PATIENT OR RECEIVED IN DON A T I O N BY T H E WARDSECTION _IN - CHARGE

6 7

RESPONSIBILITY OF STORES AT VARIOUS LEVELS

6 7

DISTRIBUTION OF MEDICINES FROM OUTDOOR DEPARTMENT

6 7

LOSS BREAKAGE DAMAGE ETC 6 8

PROCEDURE FOR WRITING OFF STORES 6 9

DISPOSAL OF WRITTEN OFF ARTICLES 7 1

FORMATS TO BE USED 7 3 - 81

32

STORAGE AND STOCK MANAGEMENT The expiry periods of pharmaceutical products have meaning only if the products are stored under proper conditions otherwise products are likely to lose their potency before the actual date of expiry

A pharmacist is a vital link in the distribution chain for pharmaceutical products The medicinal products remain for a long period during the distribution cycle at the wholesaler and at retail pharmacies It is therefore very important to maintain proper storage conditions in these units

Every community pharmacy however large or s mall needs to store and manage its medicine stocks effectively There must be systems to ensure

middot bullbull Secure storage middot bullbull Clean and correct environmental conditions during storage middot bullbull Accurate and effective record keeping middot bullbull Effective stock rotation and expiry monitoring middot bullbull Effective fire and theft prevention middot bullbull Effective rodent pest control

For easier un derstanding this module has been divided into the following sections

1 Quarantine and checking of stocks 11 Quarantine area 12 Checks to be carried out on new stocks

2 S t o r a g e 21 Need for proper storage 22 Different patterns of storage 23 Different means of storage 24 Temperatureclimatic conditions 25 Special storage of supplies 26 Storage and stability of medicines

3 Stock Control and Expiry Monitoring 31 Stock control 3 2 S t o c k r o t a t i o n a n d e x p i r y m o n i t o r i n g

4 Other aspects of s t o r a g e 41 Design of a storage area 42 Cleaning and maintenance 43 Product recalls 44 Returned goods

33

1 QUARANTINE AND CHECKING OF STOCKS

11 Quarantine Area D r u g S t o r e pharmacies receive stoc k s f r o m su pplie r s a c c or d ing to pur c h a se o r d e r s T he stock that is received must be visually checked for quality and quantity The stocks must be kept in a separate area until the checking is done to avoid intermixing with existing stock This necessitates the presence of a separate area within the pharmacy w h e r e i n t h e storage and other checking of stocks can be performed This area is called the QUARANTINE AREA This area should be marked and identified adequately to distinguish it from other areas

The area may be marked using different means 1 ) A s m a l l board saying Quarantine on a separate table used exclusively if it is in the middle 2) A board on the wall if the table on which the quarantine stock is placed is against the wall

middot Stock received from wholesalers should be immediately transferred t o t h e Quarantine Area

middot In the Quarantine area the stock may be stored on racks shelves or in cupboards to prevent ingress of moisture dirt and other contaminants

middot Regular stocks from the pharmacy should not be left kept in the quarantine area Special care has to be taken in case of refrigerated medicines supplied by the suppliers so tha t the y do not remain in the quarantine area for long periods of time They should be immediately checked on receipt and transferred to areas for refrigerated storage s o a s to maintain the cold chain bull

Advantages of having a separate Quarantine Area middot Avoids cross mixing of newly arrived stock from existing stock till it is checked middot Lays stress on checking the quality of the stock received middot S to ck checking ensures t hat defective andor expired goods do not enter the storage areas

34

bullbull

bullbull

12 Checks to be carried out on new stock

Unpacking and checking stock

Supplies received should be unpacked and checked in the quarantine area Staff doing the checks should be adequatel y trained in what they have to check when stock arrives

Checking should be seen not simply as counting the units received but as a part of the quality assurance system bullThis should include middot Visually inspecting the packaging middot Checking the integrity of containers middot V erifying the completeness and leg ibility of la b e ls ( a ppr o ve d dr u g name strength any special storage instructions and expiry date)

bull

The expiry dat e should be checked to ensure that there is adequate shelf life remaining

Supplies should be individually checked using a checklist 35

Checklists

36

The wholesaler supplying the product should be notified immediately in case of any discrepancies ( and the details should be recorded in a register) and sent in a written format to the supplier It should include middot Missing boxes or cartons middot O p en tampered boxes or cartons middot Missing supplies middot Differences in the actual quantity and the quantity shown on the packing middot Additional medicines that had not been ordered but have been supplied middot D a m a g e d b r o k e n o r p oor quality medicines middot Any other discrepancies

The purchase invoices are an important aspect to be considered The invoiced documents should be signed and filed for reference as per the Drugs and Cosmetics Act and retained for at least 3years

If the wholesaler supplies medicines as an emergency without a bill or against a delivery challan

middot The supplies should be checked for integrity and inspected for damage middot The details of supplies received should be recorded middot The supplier should be asked t o send the bill as early as possible middot When the bill is received it should be checked against the details recorded and anomalies if any should be reported to the supplier

To keep a track of the received stock maintaining a S t o c k R e c o r d C a r d c a n b e very useful The entries in the stock record card can be made while checking the stock received STOCK BIN in the stores should have Stock record card

Maintaining a stock card for every product may not be very practical for a retail pharmacy however it could be maintained for costly medicines Nowadays it is much more practical and easier to maintain records using computers

The pharmacist should ensure that medicines manufacturedmarketed by a company are received only through an authorized distribution network of that company This is important to prevent spurious and counterfeit drugs from entering the pharmacy

37

2 STORAGE 21 The need for proper storage The storage of medicines and other products is an important requirement of Good Pharmacy Pr actice Appropriate storage of medicines is essential -

middot bullTo ensure that the potency is maintained middot bullTo prevent deteriorationspoilagedegradation middot bullTo ensuremaintain physical integrity

To ascertain that the quality and safety is maintained throughout their shelf life Storage requirements need to be considered on 2 aspects

a) Integrity of medicines Medicines should be stored in such a way so as to maintain their integrity and potency middot Maintain the right temperature required middot Protect from excessive humidity middot Keep medicines away from direct sunlight middot Protect from pests and rodents

b) Physical location middot Should be easy to locate middot Accessible middot Orderlysystematically placed

2 2 D i f f e r e n t p a t t e r n s o f s t o r a g e The pharmacist could follow any of the different patterns of storage The pattern of stora ge should be selected in such a way that it facilitates speedy and efficient dispensing of medicines

The pattern of storage could vary with each pharmacy experience usual practiceroutine of staff and the person-in charge and also depending on space av ailable turnover etc (i) The medicines could be stored c o m p a n y w i s e ie the medicines manufactured by one company should be grouped together and kept in one place Within each company shelfshelves the medicines may be placed in alphabetical order for easy and quick placement and removal Also bottles tubes boxes etc may be segregated within that shelf

38

(ii) The medicines may also be stored in a lphabe t ic al o r de r ie they are placed in order from left to right based on their name The first letter of the name is used to g r o u p t h e m e d i c i n e s t o g e t h e r a n d k e e p t h e m i n o n e l o c a t i o n I n s o m e p h a r m a c i e s a l l t h e strip packing are placed in drawers or boxes in alphabetical order each box or drawer containing strips of one particular alphabet This system ensures that the strips always remain e n c l o s e d i n t h e b o x e s d r a w e r s a n d a r e n o t e x p o s e d t o d u s t T h e d i s a d v a n t a g e i s that it might lead to mix -u p o f strips in the same drawer and it may cause a problem incase of similar looking strips in which case a wrong medicine may be dispensed Secondly cut strips lying around in the drawer may lose their identity if the batch n u m b e r andor expiry date is not seen on the cut portion of the strip

39

(iii) The medicines may be stored according to their therapeutic class ( e g a n t i b i o t i c s anti asthmatics or anti hypertensives) ie the medicines are kept together based on their pharmacological or therapeutic action

(iv) The medicines may be stockedsegregated according to dosage forms eg l i q u i d s (bottles) solid oral dosage forms eye drops rotacaps ointments etc all stored on separate shelves

Always Remember I Storage of prescription medicines should preferably be separate from OTC medicines OTC medicines especially those that a r e a d v e r t i s e d m a y b e d i s p l a y e d f o r c l i e n t s t o select or to ask questions about [OTC-O v e r t h e c o u n t e r ] II Storage according to temperatures is a must no matter which pattern of storage is followed Also within a particular storage area segregated storage may be maintained In a refrigerator for example medicines may be stored in trays racks and the freezer according to the temperature required

40

Whatever pattern of storage is selected all the personnel should ensure that middot The stocks are stored in an orderly manner middot The medicines are kept back in the same place from where they were removed middot All medicines are arranged neatly once in a while

middot The personnel should be careful while storing the medicines middot They should not throw the medicines haphazardly 23 Different means of storage

middot Within each temperature and security zone medicines must be stored so that they are easily accessible and protected against damage

middot Basic means of storage include shelves racks and drawers middot To prevent dust from entering the shelvesracks it is ideal to have glass

shutterssliding glass doors This can however be disadvantageous because accessibilityspeed is hampered in removing a product from the shelf because the glassshuttersliding glass has to be

41

opened m o v e d e v e r y t i m e a p r o d u c t h a s t o b e p i c k e d u p U s e o f a i r c o n d i t i o n e r s f o r t h e p h arm acy with a closed door at the e n t r a n c e o r a n a i r c u r t a i n c a n r e d u c e t h e d u s t problem In such cases the shelvesracks may be left o p e n

bull

middot Direct storage of cartons on the floor should be avoided because besides being an unhealthy practice the contents may also be damaged by moisture bull

middot Store medicines preferably in shelves with glass shutters for visibility middot Closed shelves further prevent dust from going in especially in India where most

pharmacies are located along busy roads middot Some medicines have to be refrigerated or stored in a cool or cold place Having a

refrigerator or two (as per the need of the pharmacy) is essential to store suc h medicines at temperatures mentioned on the label bull

42

Refrigeration middot All cold chain equipment should meet required standards middot Improvement in refrigeration technology has provided frost -free refrigerators

Pharmacists should opt for frost-free refrigerators as they are easy to maintain and protect printed packaging materials Conventional refrigerators may cause water falling from trays below the freezer on medicines stored in the refrigerator thus causing soggy labels

middot bull Frost-free refrigerators also provide separate and large compartments for the freezer portion (required for storing medicines needing sub-z e r o t e m p e r a t u r e ) and the main storage area with separate doors so that opening one door does not disturb the storage temperature in the other compartment

Care should be taken to keep the refrigerator on 24 hours a day It should not be switched off after working hours It is advisable to have an inverter connected to the refrigerator so that the refrigerator re mains working even when there is a power outage

middot The refrigerator door should be closed tightly middot The refrigerator door should not be left open for too long middot Space should be left between medicines stored in a refrigerator to allow air to

circulate middot The ref rigerator should be placed about an arms length away from the wall

This will increase air circulation thus not affecting the cooling within the refrigerator

middot Vaccines should not be stored on refrigerator door shelves as they are exposed to warmer temperatures each time the door is opened Vaccines should always be stored on the middle shelves of the refrigerator

middot Refrigerated medicines should not be left out of the refrigerator for more than a few minutes

43

middot Consumable products like juices energy drinks e t c s h o u l d n o t b e s t o r e d a l o n g with medicines in refrigerators If required they may be kept in a separate refrigerator

middot An adequate number of refrigerators should be planned to store the entire stocks requiring refrigerated storage

middot Adequate procedures should be followed for defrosting cleaning and maintenance of refrigerators

middot Icefreeze packs should be kept in the freezer compartment so that they can be used for transporting cold temperature medicines The packs can be given to clients along with the medicines requiring cold temperature storage so that the temperature is maintained till the client reaches home and can then put the medicines in a refrigerator) Freezer packs can also be used to keep medicines temporarily in case there is a power outage or refrigerator breakdown

Activity

Prepare a SOP (Standard operating procedure chart) for cleaning a refrigerator Discuss it with your staff finalize its maintenance once a month through AMC -A n n u a l Maintenance contract CMC - Comprehensive maintenance contract and put it up on the pharmacy refrigerator Put the Purchase Order details name of manufacturer Phone of Service Engineer and a register to login the Machine service and down timeService reports may be maintained properly

Refrigerator monitoring and maintenance

middot bullIt is important to carry out routine monitoring and maintenance of the refrigerators and to organize an effective repair system

middot bullThe temperature in the refrigerator must be monitored and recorded routinely at least once a day

middot Any breakdown must be reco rded including the period during which the medicines were exposed to uncontrolled temperatures Medicines may then be kept or discarded depending on the problem guidelines or the manufacturers advice

middot Cold chain monitor cards and devices in or on packages that change color or otherwise alert staff to potential damage assist in monitoring (These are likely to be introduced in India soon)

middot It is essential to have a contingency plan in place before a refrigerator breaks down An arrangement can be made to move the contents to a private refrigerator elsewhere in the community or to obtain a regular supply of ice packs until the defect is rectified

Put filled water bottles in the bottom half of the refrigerator door in order to provide cooling in the refri g e r a t o r w h e n t h e r e i s a p o w e r o u t a g e T h i s m i g h t t a k e c a r e o f t h e temperature when there is no current for a couple of hours If the power outage is expected to last for several hours special arrangements such as an inverter UPS have to be made to keep the refrigerator constantly running in the absence of electricity middot Defrost the refrigerator in case of excessive ice formation and preferably at regular

intervals Keep a record of the same

44

2 4 T e m p e r a t u r e c l i m a t i c c o n d i t i o n s

i) Temperature control middot The medicines in a pharmacy need to be stored at appropriate temperatures to

maintain their stability middot An air-conditioned environment where temperature can be controlled is

recommended for pharmacies Air conditioning offers the option of setting the t e m p e rature as per requirements

middot bullIt is ideal to have an air conditioner to maintain the temperature below 25 C as most medicines require storage below this temperature Secondly this temperature is pleasing to both the staff and the visiting customers too

middot In the absence of an air conditioner circulating fans may be used middot This need is felt even more in certain parts of India where temperatures soar above 45

C and some areas where it falls to sub zero temperatures In such cases temperature maintenance is essential to prevent deterioration of medicines due to unnecessary exposure to drastic temperature fluctuations

middot This need is felt even more in certain parts of India where temperatures soar above 45 C and some areas where it falls to sub zero temperat u r e s I n s u c h c a s e s temperature maintenance is essential to prevent deterioration of medicines due to unnecessary exposure to drastic temperature fluctuations

i i ) Humidity or moisture control Moisture or humidity can adversely affect the stability of me dicines such as tablets capsules powders

45

Gelatin capsules become soft and swell on absorption of moisture The drug content of tablets may undergo surface hydrolysis The presence of moisture may encourage the growth of microbes It is therefore essential to control humidity

To reduce the effect of humidity the following suggestions may be followed -middot Open the windows to allow air circulation Use a fan to circulate fresh (outside) air middot In humid climate a dehumidifier is useful for preventing mo i s t u r e d a m a g e ( i n t h e absence of an air conditioner) middot For bulk containers of tabletscapsules do not keep the container open for a long time and replace the lid or closure immediately after taking out the required number of medicines for dispensing middot Do not allow the medicines to touch the floor or the walls The walls may be damp and may cause moisture absorption damaging the product

middot Calibrated thermometers and manometers can be used to detect temperature and humidity in the pharmacy

middot Periodici t y of checking the temperature should be fixed middot The climatic conditions should be recorded and documented middot Temperature charts should be available for ready reference

Documentation is one of the core activities for achieving and maintaining quality It is one of the most essential components of validation Temperatures in various areas

46

including refrigerators should be recorded at a predetermined periodicity usually daily at the hottest time of the day and such documents should be preserved i i i ) Storage conditions A number of storage conditions are mentioned on the labels of medicinal products These conditions have to be properly interpreted and appropriately complied with

According to the Drugs and Cosmetics Rules 1945

1 The term cool place means a place having a temperature between 10 C and 25 C

2 The term cold place means a place having a temperature not exceeding 8 C In case of storage conditions for specific products please refer to Schedule P The Drugs and Cosmetic Rules 1 9 4 5

The Indian Pharmacopoeia specifies the following storage conditions -

Wherever the condition for storage is not specified medicines may be stored under normal temperature In a country like India however where normal temperatures soar to h i gh temperatures it is recommended that medicines be stored in a cool place

Activity Prepare a list of the storage requirements mentioned on the label of about 20 products in your pharmacy and check if the temperature is maintained

47

25 Special Storage o f s u p p l i e s If the product has no special instructions normal storage conditions apply This means storage in dry clean w e l l -ventilated premises at temperatures of +15 C to +25 C or depending on the climate up to +30 C (WHO1990) Storage instructions are product specific Different brands of the same generic drug may have different storage requirements as they may have different packaging or formulations It is essential to follow the product manufacturers storage instructions to the maximum extent possible Less stable medicines must be stored in specific conditions to maintain their quality or potency

The following products require special storage facilities

middot Products that must be kept frozen (usually vaccines and sera) middot Products sensitive to h eat an d r e q uir in g r e f r ig e r a tio n ( +2 C to +8 C) middot Products that have reduced shelf life at uncontrolled room temperature and need

mechanical ventilation or air conditioning middot Flammable products that require separate fireproof premises middot Products prone to theft o r m i s u s e

Products needing storage in a controlled environment -

The usable shelf life of the following products may be reduced if stored at uncontrolled humidity or at room temperature in hot climates -

middot Some injectables (eg adrenaline) Most injectable preparations are less stable than solid oral forms (tablets and capsules) Injectable preparations in solution are particularly unstable Many injections must be protected from light as well as heat

middot Intravenous fluids (particularly if packed in p lastic containers) middot Some suppositories pessaries creams and ointments These products may melt at

temperatures greater than 30 C Once this happens it is not advisable to use them because the active ingredient in the formula may get unevenly distributed

middot Products containing rubber latex cellulose or some plastics Condoms most sterile disposable medical devices and surgical products such as syringes needles and catheters require protection from excessive humidity and strong light and heat Any o f these conditions may make products brittle stained amp unusable Sterility cannot be assumed if packaging is damaged

In hot climates these products should be stored in the coolest place possible preferably with air conditioning or air circulation fans

48

Products needing freezing or refrigeration-middot Vaccines blood products and many other medicines lose potency if kept even for a

brief period at temperatures outside the recommended range For these products the cold chain must be maintained at every stage of the distribution system

middot Freezing is as damaging as high temperatures for some products including injectable contraceptives ergometrine insulin adrenaline and the DPT DT TT and Hepatitis B vaccines Such products therefore sho uld not be allowed to freeze (not be kept in the freezer compartment)

middot Short periods at room temperature (during transportation or local distribution for instance) may be acceptable for many products (such as ergometrine a n d i n s u l i n ) e v e n t h o u g h s u c h e x posure can to some extent reduce shelf life Other items such as vaccines should always be transported in cold boxes

Storage of insulin injections-

middot Insulin should always be stored in a refrigerator at the recommended temperature of 2 -8 C

middot Insulin should not be kept in the freezer compartment of the refrigerator middot Insulin should ideally be stored horizontally middot It should not be exposed to sunlight or excessive heat middot Insulin suspensions should not be used if the suspension cannot be properly

resuspended due to cake or clump formationbull

Controlled drugs -Narcotics (for example Pethidine injection morphine preparations) and other specified drugs that may be abused are governed by special legislation and regulations The following security measures are suggested in the pharmacy -middot A safe or reinforced double locked cabinet fitted with a light (preferably with a red

bulb) that comes on when the door is opened

49

middot A special register recording details of each receipt or issue with 2 signatures physi cal counting of medicines after each entry and signatures at handover takeover

middot Independent audit (by supervisors and drug inspectors)

Products prone to theft abuse or misuse -

Some medicinesproducts are particularly prone to theft abuse or misuse These include expensive medicines (eg insulin) certain antibiotics and products prone to abuse or misuse like psychotropics etc

Such medicinesproducts should be stored adequately They require stricter record keeping and more frequent stock taki ng than others Periodic audits should be carried out to check for consumption against actual recorded use (registers prescription records stock records etc) to expose any theft or misuse bull26 Storage and stability of medicines Medicines are not stab le indefinitely They are stable for a specific period of time sometimes for a brief period Poor storage conditions accelerate the drug degradation (decomposition) Temperature light and moisture are the most important contributing factors for drug instability It is important to identify and be aware of the potential for instability There is a need to comply with storage requirements to ensure quality medicines for patients It is also important to offer advice to patients too about appropriate storage o f medicines at home The dispensing label should state the storage condition required and be backed up by a verbal reminder especially where special storage is required bull

50

In case stability and storage problems are seen with formulations they should be reported immediately to the representative of the manufacturer and taken out of circulation till the stability problems have been resolved

The pharmacist can easily detect stability problems when products show change in appearance color odor settling of the product contents breaking of emulsions melting of creams oozing of contents from the containers and any such physical changes

3 STOCK CONTROL AND EXPIRY MONITORING 3 1 S t o c k C o n t r o l For economic reasons pharmacists do not like to have stock on their shelves for long periods of time The aim should always be to keep stock at a level that will just meet demand Normally most manufactured medicines have a long shelf life Even then it is essential that there is efficient stock rot ation so that the older stock is used first It is also a good practice to check the expiry date as an integral part of the dispensing process When short shelf life products are involved stock levels may have to be modified to prevent medicines regularl y expiring on the shelves

32 Stock rotation and expiry monitoring In order to avoid accumulation of expired and obsolete stock medicines should be stored and issued according to the following guidelines -middot The stock control system must record the ex p i r y d a t e a n d t h e d a t e o f r e c e i p t middot Stock must be stored so that earliest expiring batches are picked and issued first middot The First In First Out (FIFO) system - In this system the stock which is received

first is sold first This system however may not be useful for pharmacies because most of the stocks carry an expiry date For pharmacies the FEFO system is more practical

51

middot The First Expiry First Out (FEFO) system - In this system the stock having an earlier expiry is sold first The stock with longer shelf life should be placed farthest to the back (or at the bottom in case o f sta c k e d b oxe s) T h is is pa r tic u la r ly impor ta n t with products that have short shelf lives such as vaccines some vitamins antibiotics etc and reduces losses due to expiry

middot E x p i r y dates should be noted on the stock record upon receipt Stock nearing expiry should not be accepted unless it can be used before expiry

Computerization and expiry monitoring In the pharmacy computerization facilitates both checking stocks and expiry mo nitoring and helps-bullbullKeeping a check on products nearing expiry bullbullKeeping a check on non- moving and slow moving products bullbullTo facilitate the removal of medicines nearing expiry from shelves in time to send them back to the wholesaler or supplier

Periodic checking for expiry The expiry date for medicinal products is a critical aspect in pharmaceutical dispensing and due importance should be given to it Periodic checking for expiry of medicines will ensure that the patient will never receive products that have crossed their expiry date During periodical checking of expiry the personnel involved should remove medicines that are nearing expiry bullbullIn -house threshold periods should be set and followed for retrieval of such medicines from the shelves bullbullSuch medicines should be stored separately These should either be dispensed immediately (thus ensuring that they are used before the expiry date) o r t h e y s h o u l d b e returned to the suppliers bullbullA separate area should be designated (cupboard or shelf)marked[FROZEN ZONE] which is adequately marked EXPIRED GOODS- NOT FOR SALE to store all expired stocks FROZEN ZONE

52

Remember Expired medicines are a NATIONAL WASTE So stock only what you can sell Avoid expiries save precious medicines for the nation

Treatment and disposing of expired medicines bullbullProcedures need to be in place for the treatment of expired medicines bullbullThe expired medicines need to be collected and be sent back to the supplier or company for appropriate disposal bullbullRecords must be maintained for expired medicines and how they are disposed off bullbullIn case of medicines that are not returnable to suppliers procedures for disposal need to be followed by the pharmacy in conjunction with the FDA The following procedure can be followed if medicines cannot be returned to suppliers ( T h e b a s i c p h i l o s o p h y of appropriate disposal is to prevent their re- circulation and use) bullbullC u t t h e c o n t ainer in such a manner that the label is also cut In case of tablets and c a p s u l e s d e s t r o y them by disposing them in a bucket of water bullbullUse landfill procedures (deep burial into the ground as per stipulations of Medical Waste Disposal Act prevalent in the respective state) bullbullPour the liquids into the sink and wash away with sufficient quantity of water bullbullKeep a record of such disposal with full details of medicines destroyed Although these measures are usually adopted care has to be taken with such tr e a t m e n t a s studies have shown that flushing of medicines has resulted in tracessmall quantities of medicines being found in waterways and groundwater having potential health and environmental effects

4 O T H E R A S P E C T S 41 Design of storage areas The following important factors need to be considered in design of storage areas -middot The retail outlets in hot areas in summers should be air-conditioned Similarly in

a r e a s o f e x t r e m e c o l d t h e p r e m i s e s w o u l d r e q u i r e w a r m i n g e s p e c i a l l y i n w i n t e r s t o maintain cool temperatures The placement of air -conditioners and heating devices should be such that medicines are not directly exposed to the cold or heat

middot Due consideration should be given to storage requirements of formulations while designing shelves and cupboards in retail outlets Sufficient shelf height should be provided so that all liquid products can be stored vertically As far as possible the shelves should be covered with glass panels to protect medicines from dust and p r e v e n t r a p i d f l u c t u a t i o n s i n temperature

middot Medicines should be stored according to the storage instructions on the labels bullIt is ideal to have a door at the pharmacy entrance to prevent dust from coming in as well as reduceprevent cooled air from going out This may not however be considered feasiblepracticable by many pharmacy owners for fear that clients may not enter the pharmacy because the door may act as a barrier An air curtain is a good alternative to a door

middot There should be minimal direct sunlight falling on the products Particular consideration should be given to premises directly facing the sun

middot bullThe arrangement of lighting in the interior of the premises should also be in a manner that the lights are not focused on the products It has been shown that light causes not only chemical damage but also can catalyze physical changes like moisture uptak e by the products Care should be taken to ensure that only diffused light falls on them

53

middot As far as possible provision should be made for a temperature and humidity indicator device in a pharmacy These devices are now easily available

middot Stability studies o f m e d i c i n e s p a c k e d i n b l i s t e r s h a v e r e v e a l e d t h a t i f t h e s e a r e exposed to light they tend to absorb moisture It is therefore necessary to store them in suitable cartons so that the blisters are not exposed to light Pharmacists should do this even if the manufacturer has not provided cartons

middot Light and temperature sensitive products should not be stored on counters where the light is intense or direct and there is no protection from temperature and humidity

42 Cleaning and maintenance i) Cleaning of storage areas

The storage areas of the pharmacy should be cleaned periodically and cleanliness should be maintained at all times The Standard Operating Procedure for cleaning should be designed and followed accordingly Schedules for cleanups should be laid down and adequate cleaning equipment should be made available

Tips for maintaining cleanliness middot Provide clean pieces of cloth for wiping at various locations in the pharmacy

Replace with clean cloth at regular intervals middot Keep separate pieces of cloth for floors shelves and medicines middot Use a disinfectant andor soap solution to clean floors middot Ensure removal of dust and prevent accumulation of dirt middot Ensure removal of cobwebs middot Use a vacuum cleaner for cleaning areas not easily reachable middot T a k e c a r e t h at breakages are handled and cleared effectively middot Observe the factors leading to waste generation in the pharmacy and take appropriate

measures to tackle the problem middot Record all cleaning procedures performed and maintain all the documents required

For ex a m p l e -bullbullThe floor of the pharmacy may be swept with a broom and swabbed with soap water every morning bullbullThe floor may be swabbed with a disinfectant every week bullbullThe entire premises including shelves and cupboards may be cleaned with a cloth (to remove dust and to check for medicines approaching expiry date or expired medicines) every three months bullbullAll the steps followed should be r e c o r d e d

The floor shelves drawers have to be cleaned and a check should be kept on dust cobwebs spillages due to breakage etc It is therefore essential to have SOPs for cleaning laying down cleaning frequencies allotting responsibilities and maintaining a daily record in the logbook to document all these activities

54

While cleaning dust settled on dosage forms like bottles tubes etc should be removed Before dispensing the products should also be wiped to remove any dust settled during storage

For refrigerators bullbullDefrosting and cleaning should be done at regular intervals bullbullSwitch off the refrigerator while cleaning bullbullCleaning should be done quickly and stocks put back immediately

i i ) Pest control Pests are a serious problem in India where insects reptiles and rodents (eg cockroaches l i z a r d s r a t s s i l v e r f i s h (Deemak - in Hindi ) etc) may find access to the pharmacy storage areas Insects like ants and borer ants may often attack wood in the pharmacy causing d am ag e to shelves cupboardsPest c ontr o l in a p h a r m a c y c a n b e a d i f f i c u l t t a s k b u t t o avoid possible contamination and physical damage to stock it is necessary to keep pests out of the pharmacy premisesPest control measures should be implemented with proper p r e c a u t i o n s t a k i n g u t m o s t c a r e t o a v o i d contamination of medicines

55

Th e following pest control measures c a n be ta ke n f r om tim e to tim e -bullbullRat bait and traps can be placed at various locations bullbullInsecticutors can be used on a permanent basis bullbullInsecticidal sprays and repellants can be used from time to time

i i i ) Fire precautions

Combustible trash such as cartons boxes and other packing waste must not be allowed to accumulate in the store Waste should be deposited in appropriate waste bins and be d i s p o s e d o f f o n a d a i l y b a s i s

F i re detection and fire fighting equipment must be maintained and regularly inspected The pharmacy personnel should receive adequate training in fire fighting techniques and emergency actionFire prevention measures should include a prominently displayed ldquoNoSmokingrdquo sign careful handling and disposal of combustible waste materials and checking of electrical connections at regular intervals

iv) Security middot Doors shutters of the pharmacy should be strong and be fitted with secure locks middot Counters should be designed so that unauthorized personnelclients do not have

access to areas where prescription medicines are stored Access to such areas should be restricted to the pharmacy staff

middot All the pharmacy staff handling supplies should be accountable for their ac t i o n s

56

middot bullSpecial care must be taken in case of Schedule X and manufactured drugs (under NDPS Act) Such medicines should be kept under lock and key and the key should be kept with the Chief Pharmacist or i n h i s a b s e n c e t h e s e n i o r p h a r m a c i s t

v) Breakagespillage and damaged product Products that have been damagedspoiled during storage and handling spillages and broken glassware should be disposed off according to procedures laid down by the pharmacy Broken and damaged products s h o u l d b e p l a c e d i n a segregated area to be returned to the supplier

vi) Inspection Senior staff should inspect all pharmacy areas regularly The shelves and drawers should b e c h e c k e d d a i l y f o r signs of pests and dust Ceiling and walls should be checked for dirt and cobwebs Stock should be checked on a regular basis for deterioration due to climatic conditions

43 Product recalls Products found to be defective should be quickly recalled (withdrawn from the market) The instructions are generally issued either by the manufacturer or the regulatory agency The level of recall is determined by both the degree of risk and the extent of distribution of the product and in India is mainly directed at the distribution chain

On receiving the details of the defective substandard spurious batchbatches of a medicine to be recalled from the manufacturer or the stockist or the FDA the pharmacy should immediately check if the particular b a t c h i s i n s t o c k a n d i f s o s u s p e n d i t s s a l e immediately

Similarly if the regulatory authority in the country bans a particular medicine or FDC the pharmacy should immediately check and remove all the different brands of that particular medicine under consideration

The details of medicines and their batches to be recalled should be available in the q u a r a n t i n e a r e a w h e r e stocks are received and checked This is to ensure that such medicines do not come into the pharmacy

middot The pharmacy should develop SOPs for recall of medicines middot The pharmacy staff should be immediately informed about such medicines and

the details should be displayed in writing in a prominent place in the pharmacy middot Rapid action helps avoid unnecessary exposure to such medicines once the

problem has been d e t e c t e d middot The progress of the recall procedure in the pharmacy should be monitored every

few days to ensure complete compliance middot All stocks of the recalled products should be stored separately from the saleable

stock These can be stored in the expiry cupboard segregated from the expired goods and be appropriately labeled ldquoRecal l e d G o o d s - Not for Salerdquo

The supplier should be notified and asked to replace defective products middot All the details of the procedures followed should be duly recorded in a Recall

Register maintained specially for the purpose The register should include d etails such as -middot Date of the recall middot Nam e of the product

57

bullbull

middot Details of the product (name of manufacturer batch number expiry date) middot Nu m b er of units purchased sold a n d sto c k in ha nd middot Reason for recall middot Nam e of the supplier to whom produc ts w e r e returned along with the date and quantity middot Name and signature of the designated personnel carrying out the recall procedure and recording details middot Name and signature of the chief pharmacist verifying the recall procedures and recording details 4 4 Returned medicines

Medicines may be returned to the pharmacy by clients due to the following reasons -bull

bullbull Unused medicines bullbull Course not completed bullbull Therapy changed by doctor bullbull Side effects experienced by patient bull

bullbull DamagedDefective medicines bullbull Missing or defaced label bullbull Missing tablets in a stripblister bullbull Leakage in bottles bullbull Leakage in strips bull

bullbull Expired medicines

Appropriate SOPs should be framed and followed for their acceptancerefusal and disposal middot bull For unused medicines returned by clients the p harmacy personnel should verify

that these were purchased from their pharmacy They should then be checked for integrity of the packing the dosage form and the expiry date and verified with the client whether they were stored in appropriate conditions This again is at the discretion of each pharmacy

middot The damageddefective medicines returned to the pharmacy should be taken back and stored separately Existing stock of the same product should be checked for similar defects

middot Expired medicines should be accepted from clients at the discretion of the pharmacist and be immediately shifted to the expired goods cupboard These can be stored segregated from the pharmacys own expired goods and be appropriately labelled ldquoExpired Goods returned by clients- Not For Salerdquo

It is advisable not to accept returned medicines requiring cold chain storage (refrigeration) because it cannot be ensured that the cold chain was maintained when the medicines were in the hands of the patientclient middot Appropriate adjustments in t he stocks should be made for medicines

returnedexchanged to update the inventory middot The medicines should then be returned to the respective shelves middot A lsquoReturned Goodsrsquo register needs to be maintained to record all details of returned

medicines

R egister should include such details as-

58

middot N a m e o f t h e p a t i e n t middot Nam e of the product and quantity r e tu r n e d middot Product details such as the batch number and expiry date middot Condition in which received middot Reason for returning products middot Compensatory measures taken wi t h r e s p e c t t o c l i e n t middot Action taken with respect to product middot Name and signature of the personnel accepting the returned medicines and recording details middot Name and signature of the chief pharmacist verifying the recorded details

What the pharmacist would have learnt from this module The storage of medicines is a critical factor in the distribution cycle bullbull Stocks received by the pharmacy should be quarantined in a separate area and necessary checks s h o u ld be performed to ascertain the qua lity a nd quantity of stocks received bullbull Whatever pattern and means of storage used the products should be stored so as to maintain their potency and integrity bullbull Storage conditions should be monitored and maintained on a regular basis bullbull Optimum stock levels should be maintained and regularly monitored for expiry bullbull The design of storage areas should facilitate appropriate storage of medicines bullbull Cleanliness should be maintained in the pharmacy bullbull Adequate measures should be taken in case of returned medicines and recalled products

Optimum storage of medicines is mandatory whether at the distribution stage at the pharmacy or ultimately within the homes of patients The pharmacist has an important r o l e t o p l a y i n t h e s t o r a g e o f m e d i c i n e s i n m a i n t a i n i n g d r u g p o t ency and efficacy and thus facilitating optimum therapeutic benefits Good Pharmacy Practice - IPA -CDSCO - WHO Appendix I Quality Assurance Templates of letters for use if found not of Standard Quality [Frozen and expired goods ]

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated To Name of the Supplier with address

Sub Not of Standard Quality GoMP-Supply of Drugs and medicines-(Codename) Return of Stocks to the Suppliers-reg(New drug policy 2009) Previous letterinvoice ref Sl No Drug Code Drug name

Manufacturing date Expiry date

Supplier address

B a t c h n o

The above items of PO nodated was drawn by the Drug Inspector (Place) on (______________date) as a statutory sampling and declared ldquoNot of Standard

59

Qualityrdquo on -(______________date) by the Government Analyst for the following reasons

- ldquoThe product sample do not confirm to IP specification for (Drug codename with respect to the content of drugrdquo

- ldquoThe product has already been blacklisted by TNMSC on -(______________date) for the failure of (quantity) of batches of drug codenamerdquo

As per the clause of the te nde r d oc um e nt ldquo I f the sa mple s d o not c onf o r m to statutory standardsthe tenderer will be liable for relevant action under the existing laws and the entire stock in such batch should be taken back by the tenderer within a period of 30 days o f t h e r e c e i p t o f t h e l e t t e r f r o m t h e v e n u e

The stock shall be taken back at the expenses of the tendererthe Procurement Authority have the right to destroy such Not of Standard Quality if the tenderer does not take back the goods within the stipulated time

The Procuring Authority will arrange to destroy the Not of Standard Quality drugs within 90 days after the expiry of 30 days mentioned above without further notice and shall also collect demurrage charges calculated at the rate of 2 per week on the value of the drugs rejected till such destructionrdquo

Hence we regret to inform you that you will have to take back the stocks available of the abovesaid batch at your own cost from the drug stores where you have supplied the above batch

Kindly acknowledge the receipt of this reference at once

P r o c u r e m e n t A u t h o r i t y Seal and Stamp

Copy to Ref No dated

1 ) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated13082010

To

Sub Frozen Drugs-ordered to return to the Suppliers-reg(New drug policy 2009) Previous letterinvoice ref

The following products which were earlier frozen have now been ordered to return to suppliers directly with permission from the State drug Authority In this regard the suppliers have been instructed to take back their failed batch from the drug store of the stores Hence you are now instructed to return the following failed batches to the suppliers by obtaining proper authorization letter and acknowledgements from them

60

Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

Kindly acknowledge the receipt of this reference at once

Procurement Authority Seal and Stamp

Copy to

Ref No dated 2) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated14092010

To

Sub Frozen Drugs-ordered to return to the Suppliers- for issue of gate pass after verification reg(New drug policy 2009) Previous letterinvoice ref

The following products which were earlier frozen have now been released Hence they may be issued Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

Kindly acknowledge the receipt of this reference at once

Procurement Authority Seal and Stamp

Copy to

61

Ref No dated 3) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated

To

Sub Stop instruction-reg(New drug policy 2009) Previous letterinvoice ref

Until further instructions stop issue all the batches of the following item Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

You must intimate the available stock in the stores of the said batch Number to the Procurement Authority immediately Also retrieve quantity if already issued

Procurement Authority Seal and Stamp

Copy to

Ref No dated 4) HOD Procurement Office of

62

Appendix II Material handling in drug stores

Rack approx rates and dimensions

S No

Item Description UOM Approx Rate

1 MEDIUM DUTY RACK SIZE 2900 H X 3090 W X 800 D IN MM (AS PER SPECIFICATION)

Each 2499800

2 MEDIUM DUTY RACK ADD ON UNIT FOR SIZE OF SR NO2

Each 2243100

To locate a Box no 3 Rack no 14 in row3

SAMPLE OF RACK no Bin numbering -------------- S a y R K 1 4 R o w 3 B o x 1 6

SAMPLE LAYOUT of RACKS in a Drug Stores

63

Sample of another warehouse of distribution warehouse system

64

65

Slotted Angle racks with bin cards

66

Plastic Pallets

Plastic pallets ar e l i g h t w e i g h t l o w- c ost and exceed industry standards for strength and durability

NOTE A pallet has bottom deckboards (see sketch) A skid does not have bottom

67

deckboards

Battery Operated Stacker

Electric Stacker Ehh (Manual Push Type) - Manual drive - Lifting electrically with Battery 12 V 88 Ah - For loading and un-loading of trucks - Battery and loading device built - in - Battery charge gauge and charging current gauge Simple and Easy Operation - Lifting and Lowering electrically direct on steering arm - Pulling and pushing through steering arm - Electrically operated relief valve on hydraulic aggregate Safe Operation - Emergency Off Switch - Constant lowering speed - Protection through lowering brake valve - Overload protection through overload brake valve - Load chains covered preventing pinching threat - Electrically interlocking during loading process - Secured battery compartment opens upwardly - Stable buffering of the steering arm in upright position - In accordance with EWG Guidelines 89 240 - In accordance with VBG 12b Prevention of Accidents

Pallet Truck [ Top ]

68

----------------------------------------------------------------------------------------------------------------------------

For Transport Of All Goods On Pallets Safe and Easy Operation - through single hand operation Lifting moving

lowering with steering handle - neutral position of the hydraulic possible - overload pressure relief valve Long Service Life - robust co n s t r u c t i o n

- special hardened axles - hardened chromium plated ram - maintenance free Easy Maneuverability - through rubber steering rollers - nylon fork rollers

A h a n d t r o l l e y

69

Trolley with plastic bins for several items del ivery

70

Digital Weighing balances

Balances amp Scales EF Seriers Precision Electronic Balance

71

1

Ice lined Refrigerators

600 litres refrigrator

72

Walk in cooler

vacuum cleaner

73

VII PROCEDURE OF INDENTING FOR WARD amp OTHER SECTIONS OF THE INSTITUTION

(a) There has to be an Indent Book with every such section wh ich receives and issues medicinesequipment

( b ) The indent shall be prepared by the nurse Compounded -i n -c ha r g e of th e WardSection in te single copy on the Performa (Annexure A)

(c) The indent so prepared will be signed by the medical officer resident ndash i n c h arge or in his absence by a doctor senior to him but associated with the ward section

( d ) The indent shall then be signed by the head of the institution (Superintendent or the Civil Surgeon as the c a se ma y be ) o r b y his A ssista n t if th e la tte r is so authorized in writing

(e) The indent book is then presented to the main Store for effecting issue (f) The Store will then prepare issue vouchers (Annex B) in triplicate as directed

in Paragraph V (b) supra The supplies and the Indent Book are taken back by the Ward Section- i n - charge after signing the first copy of the issue voucher

(g) Te supplies after arriving in the WardSection shall be entered on the WardSection stock register which is prepared on a proforma (Annexure E) and page number of each entry be shown o n t h e 2 n d a n d 3r d copies of the Issue

voucher The 2 n d copy of the voucher is to be retained in a file in the wardsection but the 3r d c o p y s h o u l d b e r e t u r n e d t o t h e s t o r e b e f o r e s u b m i t t i n g a fresh indent The Store has to be maintain separate files of the 3 r d copies Wardsection-wise

VIIIHOW OFTEN TO INDENT

(a) A wardsection ndash i n -charge should work out an average weekly expenditure of each item and efforts be made to replenish the WardSection stocks every week

( b ) T h e M a i n s t o r e i n o r d e r t o a v o i d h e a v y rush of work should fix a day of issue for each major specialty T w o or th r e e minor spe c ia ltie s c a n be gr o upe d f o r one day

IX EMERGENT INDENT It is very likely for unforeseen reasons either the weekly indent of WardSection stock might get exhausted earlier or something which was not there in the lsquoweekly indentrsquo is required Under such circumstances an ldquoEmergent Indentrdquo could be made out in the usual manner but under the signature of the Unit-i n- chargeconsultant and it must be countersigned by the head of the institution (and not by his assistant) These supplies have also to be entered in the wardSection stock books like others

13

X HOW TO INDENT

(a) The ward Section -i n - c h a r g e s h o u l d e n s u r e t h a t t h e s t o c k s u n d e r t h e i r c h a r g e a r e not unnecessarily large and only a realistic quantity is indented once a week

( b ) The indent should not be made out in the names of the patients or by bed numbers The indent should be for the Wardsection as a whole

XI KEEPING OF RECORDS IN WARDS AND SECTIONS

(a) A set p r o f o r m a ( A n n e x u r e E ) s h o u l d b e u s e d i n t h e w a r d s e c t i o n f o r s h o w i n g u p receipts and issues Balance of expenditure for each item to be drawn out every morning by nursecompounder in charge before writing out the Indent or before restarting work The medica l O f f ic e r r e side nt in c ha r g e sh ould a tte st th e e ntr ie s after satisfying himself- by random checking at least once a week

( b ) To support the above mentioned expenditure the Bed head Tickets (treatment charts) are very important Each medicine prescribed should be legibly written indicating the total quantity prescribed if the medicine is to be deleted from treatment the fact should be mentioned as to how much of the drug was issued to the patient before switching on to another drug The suggestion is that a separate treatment card be maintained for each indoor patient ( Annexure ndash G) A summary s h o w i n g t h e t o t a l a m o u n t o f t h e p r o p r i e t a r y d r u g s c o n s u m e d b y t h e p a t i e n t d u r i n g is hospital stay be worked out and noted in the summary card

XII ACCOUNT ABILITY OF DRUGS BROUGHT BY THE PATIENT OR RECEIVED IN DONATION BY THE WARDSECTION _IN -C H A R G E

The drugs receoived from the non - governmental sources should be entered on the receipts side of the WardSection Sto c k b ook a n d issu e s to show n a s in th e o the r cases on the issues side

XII RSPONSIBILITY OF STORES AT VARIOUS LEVELS (a) The head of the institution shall be held responsible for non-observance of

rulesprocedures laid down by the Government ( b ) The Medical officerresident in charge of the stores and the store keeper shall be

held responsible for any irregularity found in the stores or for ignoring the ordered pattern of working It shall be the duty of the Medical officer Incharge of the Stores to occasionally check the WardSection Stock-b o o k s t o t a l l y t h e e n t r i e s made in the 3 r d copy of the Issue vouchers [as laid down under V (b)supra ]

(c) The Medical officerresident in charge of the WardSection shall be responsible for irregularities in indenting stocksfor maintaining stocks much in excess of the req uirement and for improper keeping of BED HEAD TICKETS (treatment chartsCards)

( d ) The NurseCompounder ndash i n -charge of the WardSection shall be responsible for shortages in stocks for putting up inflated indents and or for not taking into account medicines b rought by the patientson the WardSection stock-books Heshe shall also be held responsible for ensuring proper distribution of medicines to each and every patient under his her charge

XIV DISTRIBUTION OF MEDICINES FROM OUTDOOR DEPARTMENT (A) ( a ) T h e r e are proprietary and non -proprietary medicines (like mixtures ointments

and lotions) which are to be distributed gratis to patients 14

(b) The Outdoor incharge shall arrange to maintain a stock of common drugs (list of which shall be prepared by the Head of t he Institution) and arrange to replenish the stocks once a week as has been laid down for wards (c) No proprietary drugs shall be issued on the prescription of an intern ( d ) The Head of the institution shall make out a list of drugs which can be issued on

the prescription of a houseman from the Outdoor stock without the countersignature of any other authority

(e) The residents can prescribe any drug from Outdoor stock without the counter signature of any authority

(f) The Consultants can prescribe any drug to any ot h e r o u t e r p a t i e n t e v e n i f i t i s n o t s t o c k e d i n t h e o u t d o o r b u t t h i s s h a l l h a v e t o b e c o u n t e r s i g n e d b y t h e h e a d o f t h e institution for issue from The Main Store

(B) T h e p e r s o n i n c h a r g e o f t h e O u t d o o r m e d i c i n e s s t o c k s h a l l k e e p a r e c o r d o f t h e q u a n t i t y o f t he medicines issued to each patient and instead of writing the name and other details e may only put down the Registration number of the patient and the quantity issued

At the end of the day he must work out the total expenditure of eac item and draw it s balance

The Medical officer in charge of the Stores and the Head of the institution sould check these records at least once a week and affix is signature to confirm their inspection

(C ) No proprietary medicine shall be issued without a valid issue s l i p ( A n n e x u r e- F)

(a) For Housemen the slip would be of brown colour ( b ) For residentsDemonstrators it shall be of pink color (c) For consultants the issue slip should be white ( d ) All issue slips should be printed and pages serially numbered (e) T h e d o c t o r s t o w h o m s u c h i s s u e s l i p s w o u l d b e i s s u e d s h a l l b e h e l d

responsible for their sa f e ke e ping a n d th e y w ould e n su r e tha t th e se slip s would be printed and serially numbered

(f) The doctors prescription slips (for issue from hospitals) of proprietary drugs be prepared in du plicate with the help of carbon One copy should be given to patient for obtaining medicines from the Stores and the other would remain in the Doctors Prescription Slip book

(g) Every issue Slip should be signed and below the signatures a rubber s t a m p s h o w i ng name and designation be affixed The Store people would n o t h o n o u r s l i p u n l e s s t h e n a m e o f p r e s c r i b e r i s c l e a r a n d h i s a t t e s t e d signatures are available to stores

( h ) The Store Staff would file prescription slips of each doctor separately to facilitate the scrutiny at least once a month by the Head of the Institution Such a Scrutiny would reveal over prescribing of or injudicious use of drugs

(C) Proprietary medicines should not be issued for more than three days requirement at a time The only exceptions being cases for cancer pulmonary tuberculosis and leprosy In exceptional cases an officer not below the rank of a Consultant can prescribe for more than 3 days but after the countersignatures of the Head of the Institution

15

XV LOSS BREAKAGE DAMAGE ETC

(A) Any loss of public money departmental revenue of receipts stamps stores or other property held by or on behalf of the Government caused by defalcation or otherwise discovered in an office or institution should immediately be reported by the officer concerned to the head of department through his immediate superior as well as to the Accountant General if the loss exceeds Rs 20000(fig of 1977) (for Proforma see Annexure I)even when such loss has been made good by the party responsible for it Such reports must be submitted as soon as possible and soon after suspicion arises that there has been a loss they must not be delayed while detailed enquiries are made

When the matter has been fully investigated further and complete report should be submitted of the nature and extent of loss showing the errors or neglect rules by which such loss showing the errors or neglect of rules by which such loss was rendered possible and prospects of effecting such recovery

The s ubmission of such a repot does n o t d e b a r t h e l o c a l a u t h o r i t i e s t a k i n g f u r t h e r a c t i o n which may be deemed necessary like handing over the case to the police

Every Government servant should realize fully and clearly that he will be held personally responsible for any loss sustained by the government through fraud and negligence on is part and that will also be held personally responsible for any loss arising from fraud or negligence on the part of any other Government servant to extent to which it may be shown that he has contributed to loss by his own action or negligence

A s s o o n a s s h o r t a g e i n s t o c k o r l o s s i s d i s c o v e r e d a p a r t f r o m r e p o r t i n g t h e m a t t e r a responsible officer should be deputed to investigate the matter

W h e r e t h e r e i s n o l i k e l i h o o d o f a d e l i b e r a t e t h e f t b u t l o s s i s a result of neglect onlythe loss should be made good by the person on whose charge or custody the article lost remained

(B) As soon as damage or breakage of Government property is detected certain steps mentined under should be undertaken-

(a) A p r o m p t t h o ro u g h i n v e s t i g a t i o n i n t o t h e c a u s a t i o n o f b r e a k a g e o r d a m a g e s h o u l d be undertaken by the doctor-i n -charge of the WardSection or by the Head of the Institution

( b ) The investigating officer should draw conclusions as to whether the breakagedamage has been a result of-

(i) C a r e l e s s a n d n e g l i g e n t h a n d l i n g ( i i ) Unpredictable action of the patient for whom the equipment was

being used (iii) Accidental ( i v ) Manufacturing Defect

A report is then prepared in duplicate by person in charge of the article under question on the lsquobreakage and loss proformarsquo (See Annexure H)

16

These reports have to be signed by the investigating officer and are to be then submitted to competent authority for suitable action One copy which is returned is to be kept with the Stock Register In cases where the b r e a k a g e o r d a m a g e i s o f s u c h b i g g e r d e g r e e t h a t s atis factory repairs are not possible a n d if suc h b r e a k a ge o r da m a ge is o f su c h a de gr e e that satisfactory repairs are not possible and if such breakage or damage has been caused-

( i ) B y a G o v t s e r v a n t because of negligent or careless handling cost of the article should be recovered from him and credited to the treasury (ii)On account of reasons mentioned above that is un predictable action of the patient accidental or manufacturing defectthe article could be written offsubject to powers delegated to the concerned for such purpose

(C )Shortages detected during biannual physical verification of the Storeshave to be dealt in a similar manner

(D) it shall be at discretion of the competent authori ty (who is empowered to write off the loss) to reduce the amount of recovery upto 50 of the cost of article provided that before arriving at such a decisionhe has taken into account the following points (a) Normal life span of the article under questi on (b) Period for which it has been in use (c ) Condition of the article at the time of loss or damage and (d) Whether it was on account of careless or negligent act or not

XVI PROCEDURE FOR WRITING OFF STORES

(a) When any Stores become unserviceable otherwise than in ordinary course or by fair wear and tear their value should be treated as loss to the Government and in such cases cost should be recovered from the person responsible for his negligence

( b ) A s t r i c t w a t c h s h o u l d b e k e p t o n t h e m e d i c i n e s w h i ch bear an expiry date and if there is no likelihood of their being utilized locally intimation of the fact should be sent to Directorate of Health services and also to all o t h e r d i s t r i c t s s i m u l t a n e o u s l y s o t h a t t h e y c a n b e p u t t o u s e b e f o r e t h e expiry date In the event such a course is not followed and the Government i s p u t t o l o s s c o s t o f t h e m e d i c i n e i n q u e s t i o n s h a l l b e r e c o v e r e d f r o m t e defaulter

(c) For declaring articles as unserviceable a Committee of three members should be formed in each officeinstitution This Committee should examine each and every article brought before it and should record full reasons for condemning them and also say how the articles condemned have to be disposed of-whether by sale (by public auction) or otherwise

I f t he local Authority is not competent to write off the articles condemned by the Committee it should send the proposal to the higher authority for suitable a c t i o n

17

In Institutions where there is only one doctor a list of articles to be condemned should be p r e p a r e d a n d o r d e r s o n i t b e o b t a i n e d f r o m t h e inspecting authority during inspection

While preparing any list of articles for condemnation details regarding the date of purchase date of receipt period during which it remained in use usual life of the article and its purchase price should be noted against each item

( d ) The condemned articles should not be struck off the Stock Register till the competent authority sanctions its write ndashoff Details of Authority under which the article has been written off should be mentioned in stock register

XVII DISPOSAL OF WRITTEN OFF ARTICLES

Articles like linen should be torn into strips 10cm width so that they could be burnt or given to Government Jails for making carpets

Items like bed -pans bowlsurine po ts etc should be crushed and kept for auction

Brass utensils have also to be crushed to destroy their shape and could be either auctioned or after inviting rates from several dealers could be locally sold to highest bidder

In case when condemned ar ticles have to be sold by public auction they should be stored safely and the Government Auctioneer be intimated In case he expresses his inability to undertake the auction the officer should proceed with the auction departmentally The sale proceeds in either case should be credited to the Treasury as miscellaneous receipts under the Proper head of account

XVIII PHYSICAL VERIFICATION (a) The stocks held by officesinstitutions in various sections should be physically

verified twice a yearin the months o f April and October ( b ) Checking should be done by an officer other than te one who holds the charge of

Stores (c) Verification should be done in presence of officer holding the charge of Stores ( d ) All discrepancies found during the verification should be properly investigated

and accounted for

(j) Any excess detected during verification should be entered in the Stock book as Receipts with the remark ldquo Excess found on verificationrdquo

(ii)any shortage should be noted in issues column of lsquo Issuesrsquo described as lsquoshortage fou n d o n v e r i f i c a t i o n rsquo

XIX ANNUAL STORES ACCOUNT This account should be prepared according to the instruction issued from the department from time to time This should account for the outgoing financial year on the following lines -(a) Cost of the articles under various heads on the last day of the previous

year 18

( b ) Cost of the articles under the various Heads Received during the year (c) Cost of various articles written off during the year under review ( d ) Cost of the articles on the last day of the year or on the firs t d a y o f t h e

financial year following

19

Annexure A WardSection Indent Register No Issued on

Name of institution Page Folio No

Serial no Name of Article Quantity in Stock

Quantity required

Prepared by Approved by Recd by Note-Indenting Officer to sign and affix seal with name and

designation below the last item to avoid additions in one strokeno issues to be made by storesif Issue vouchers of

previous Indent has not been returned back by the WardSection

20

Annexure B Issue Voucher No (printed number)

Supplied to Wardsection Date

Indent no

Serial no Name of Article Quantity in Stock

Quantity required SB No

Stores-in MO Resident in Sign of charge charge WardSection

NurseCompounder Prepared by Recd Approved by by

Note-Indenting Officer to sign and affix seal with name and designation below the last item to avoid additions in one strokeno issues to be made by storesif Issue vouchers of previous Indent has not been

returned back 1st copy-Stores 2nd copy -Wardsection3rd copy-Tobe reurned to sores with Stock book entries

21

Annexure C

STOCK REGISTER FOR DEAD STOCKS

SERIAL NO DATE OF RECEIPT

Article with description

No of pieces Cost Details of

Bill Signature No Disposed

Date of disposal

Manner of Disposal

with Authority

Value realised Signature

1 2 3 4 5 6 7 8 9 10 11 12

P r e p a r e d B y C h e c k e d b y A p p r o v e d b y

Date Designation Name of Institution

22

Annexure D

STOCK REGISTER FOR EXPENDABLE ITEMS Name of article

Date

From where

received with cost

Quantity Signature To whom issued Quantity Balance Signature

1 2 3 4 5 6 7 8

23

Annexure E

Receipt amp Issue Register for WARDSSECTIONS (one or more pages as per requiremnt for each medicine)

NAME OF MEDICINE RECEIPT ISSUE

DATE Quantity In Stock

Date of

Issue

Issued toMention Bed no amp

quantity (in bracket) (For

Outdoor cases give Regd No)

Balance Signature

24

Annexure -F

OUTDOOR FREE MEDICINE SLIP In Duplicate

Name of Patient Registered No Date

Sr no Name of Medicine Quantity

Seal amp sign of doctor

25

Annexure-G

TREATMENT CARD

WARD NO

NAME OF PATIENT BED NO DATE amp TIME OF ADMISSION DATE amp TIME OF DISCHARGE

DATE MEDICINES PRESCRIBED SIGNATURE

26

ANNEXURE -H

PROFORMA FOR BREAKAGE amp LOSS

NAME OF OFFICEINSTITUTION DATE PLACE

SRNO NAME amp

DESCRIPTION OF ARTICLE

COST DATE OF PURCHASE

REASON CAUSE OF BREAKAGE

RECOMMENDATION OF INVESTIGATING AUTHORITY

Signature

Orders of the Competent Authority

Signature

27

Annexure ndash I Loss- Procedure for Reporting

1 The exact nature of the defalcation 2 The full extent of loss 3 The actual period covered by the defalcation 4 The defects in the negle c t o f r u le s by w hic h the loss was rendered possible

and circumstances which facilitated the defalcation 5 The names of the officials held personally or technically directly or

indirectly and wholly or partially responsible for the irregularity c o m m i t t e d i n t h e c a s e

6 Whether the c a s e a s b e e n J u d i c i a l l y t r i e d i n a c o u r t o r n o t i f s o c o p i e s ( i n duplicate) of the Judgment may please be furnished Copy of police report may also be furnished

7 The remedial measures adopted as safeguards against the losses hereafter 8 The prospects of re covery of the loss and he action taken to effect

recovery together with the amount recovered 9 Head of Account to which the Loss is debitable may be informed

Signature of Head of Office with seal

NoteA copy of this report is to be sent to AGMPThis is as per M P Finance Code Vol I

28

STORAGE AND STOCK MANAGEMENT

29

Foreword

The New Drug Policy 2009 is being implemented in the State of Madhya Pradesh

In order to have a proper procedure for Storage maintenance and expiry management of the drugs it is necessary to follow Good Storage Practices with Standard Modules for pharmacistStore keepers

Proper guidelines on Storage Practices can lead to better Stores and inventory upkeep with medicines being properly stored in racks with proper cleanliness and hygiene

This is a step towards storage maintenance and expiry management at the various stores in the state Looking forward to see that the heads of all health facilities take benefit from this module

D ir e c t o r M e d i c a l S e r v i c e s

30

INDEX

Sr No P a r t i c u l a r s P a g e

1 S T O R A G E A N D S T O C K M A N A G E M E N T 4

1 Quarantine and checking of stocks 11 Quarantine area 12 Checks to be carried out on new stocks

2 S t o r a g e 21 Need for proper storage 22 Different patterns of storage 23 Different means of storage 24 Temperatureclimatic conditions 25 Special storage of supplies 26 Storage and stability of medicines

3 Stock Control and Expiry Monitoring 31 Stock control 32 Stock rotation and expi r y m o n i t o r i n g

4 Other aspects of storage 41 Design of a storage area 42 Cleaning and maintenance 43 Product recalls 44 Returned goods

2 A p p e n d i x 1 Templates of letters for use if found not of Standard Quality [Frozen and expired goods ]

Frozen Drugs-ordered to return to the Suppliers-reg(New drug policy 2009)

Frozen Drugs-ordered to return to the Suppliers- for issue of gate pass after verification reg(New drug policy 2009) Stop instruction-reg(New drug policy

2009) Appendix II Material handling in drug stores

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3 PROCUREMENT ndash Government Order Relating to

the Management of Stores

(Reproduced for reference material on basic

procedure in decentralized system followed by

Health facilities in 1977)

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F L O W C H A R T S f o r a BI R D S E Y E V I E W o f

P R O C U R E M E N T

5 5

ACQUISITION OF STORES 6 1

PLACING OF ORDERS 6 2

RECEIPT OF STORES 6 2

CUSTODY 6 3

ISSUE OF STORES Maintenance of Stock Books

6 3

PROCEDURE OF INDENTING FOR WARD amp OTHER SECTIONS OF THE INSTITUTION

6 4

HOW OFTEN TO INDENT 6 5

EMERGENT INDENT 6 5

HOW TO INDENT 6 5

KEEPING OF RECORDS IN WARDS A N D S E C T I O N S

6 6

ACCOUNTABILITY OF DRUGS BROUGHT BY THE PATIENT OR RECEIVED IN DON A T I O N BY T H E WARDSECTION _IN - CHARGE

6 7

RESPONSIBILITY OF STORES AT VARIOUS LEVELS

6 7

DISTRIBUTION OF MEDICINES FROM OUTDOOR DEPARTMENT

6 7

LOSS BREAKAGE DAMAGE ETC 6 8

PROCEDURE FOR WRITING OFF STORES 6 9

DISPOSAL OF WRITTEN OFF ARTICLES 7 1

FORMATS TO BE USED 7 3 - 81

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STORAGE AND STOCK MANAGEMENT The expiry periods of pharmaceutical products have meaning only if the products are stored under proper conditions otherwise products are likely to lose their potency before the actual date of expiry

A pharmacist is a vital link in the distribution chain for pharmaceutical products The medicinal products remain for a long period during the distribution cycle at the wholesaler and at retail pharmacies It is therefore very important to maintain proper storage conditions in these units

Every community pharmacy however large or s mall needs to store and manage its medicine stocks effectively There must be systems to ensure

middot bullbull Secure storage middot bullbull Clean and correct environmental conditions during storage middot bullbull Accurate and effective record keeping middot bullbull Effective stock rotation and expiry monitoring middot bullbull Effective fire and theft prevention middot bullbull Effective rodent pest control

For easier un derstanding this module has been divided into the following sections

1 Quarantine and checking of stocks 11 Quarantine area 12 Checks to be carried out on new stocks

2 S t o r a g e 21 Need for proper storage 22 Different patterns of storage 23 Different means of storage 24 Temperatureclimatic conditions 25 Special storage of supplies 26 Storage and stability of medicines

3 Stock Control and Expiry Monitoring 31 Stock control 3 2 S t o c k r o t a t i o n a n d e x p i r y m o n i t o r i n g

4 Other aspects of s t o r a g e 41 Design of a storage area 42 Cleaning and maintenance 43 Product recalls 44 Returned goods

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1 QUARANTINE AND CHECKING OF STOCKS

11 Quarantine Area D r u g S t o r e pharmacies receive stoc k s f r o m su pplie r s a c c or d ing to pur c h a se o r d e r s T he stock that is received must be visually checked for quality and quantity The stocks must be kept in a separate area until the checking is done to avoid intermixing with existing stock This necessitates the presence of a separate area within the pharmacy w h e r e i n t h e storage and other checking of stocks can be performed This area is called the QUARANTINE AREA This area should be marked and identified adequately to distinguish it from other areas

The area may be marked using different means 1 ) A s m a l l board saying Quarantine on a separate table used exclusively if it is in the middle 2) A board on the wall if the table on which the quarantine stock is placed is against the wall

middot Stock received from wholesalers should be immediately transferred t o t h e Quarantine Area

middot In the Quarantine area the stock may be stored on racks shelves or in cupboards to prevent ingress of moisture dirt and other contaminants

middot Regular stocks from the pharmacy should not be left kept in the quarantine area Special care has to be taken in case of refrigerated medicines supplied by the suppliers so tha t the y do not remain in the quarantine area for long periods of time They should be immediately checked on receipt and transferred to areas for refrigerated storage s o a s to maintain the cold chain bull

Advantages of having a separate Quarantine Area middot Avoids cross mixing of newly arrived stock from existing stock till it is checked middot Lays stress on checking the quality of the stock received middot S to ck checking ensures t hat defective andor expired goods do not enter the storage areas

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bullbull

bullbull

12 Checks to be carried out on new stock

Unpacking and checking stock

Supplies received should be unpacked and checked in the quarantine area Staff doing the checks should be adequatel y trained in what they have to check when stock arrives

Checking should be seen not simply as counting the units received but as a part of the quality assurance system bullThis should include middot Visually inspecting the packaging middot Checking the integrity of containers middot V erifying the completeness and leg ibility of la b e ls ( a ppr o ve d dr u g name strength any special storage instructions and expiry date)

bull

The expiry dat e should be checked to ensure that there is adequate shelf life remaining

Supplies should be individually checked using a checklist 35

Checklists

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The wholesaler supplying the product should be notified immediately in case of any discrepancies ( and the details should be recorded in a register) and sent in a written format to the supplier It should include middot Missing boxes or cartons middot O p en tampered boxes or cartons middot Missing supplies middot Differences in the actual quantity and the quantity shown on the packing middot Additional medicines that had not been ordered but have been supplied middot D a m a g e d b r o k e n o r p oor quality medicines middot Any other discrepancies

The purchase invoices are an important aspect to be considered The invoiced documents should be signed and filed for reference as per the Drugs and Cosmetics Act and retained for at least 3years

If the wholesaler supplies medicines as an emergency without a bill or against a delivery challan

middot The supplies should be checked for integrity and inspected for damage middot The details of supplies received should be recorded middot The supplier should be asked t o send the bill as early as possible middot When the bill is received it should be checked against the details recorded and anomalies if any should be reported to the supplier

To keep a track of the received stock maintaining a S t o c k R e c o r d C a r d c a n b e very useful The entries in the stock record card can be made while checking the stock received STOCK BIN in the stores should have Stock record card

Maintaining a stock card for every product may not be very practical for a retail pharmacy however it could be maintained for costly medicines Nowadays it is much more practical and easier to maintain records using computers

The pharmacist should ensure that medicines manufacturedmarketed by a company are received only through an authorized distribution network of that company This is important to prevent spurious and counterfeit drugs from entering the pharmacy

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2 STORAGE 21 The need for proper storage The storage of medicines and other products is an important requirement of Good Pharmacy Pr actice Appropriate storage of medicines is essential -

middot bullTo ensure that the potency is maintained middot bullTo prevent deteriorationspoilagedegradation middot bullTo ensuremaintain physical integrity

To ascertain that the quality and safety is maintained throughout their shelf life Storage requirements need to be considered on 2 aspects

a) Integrity of medicines Medicines should be stored in such a way so as to maintain their integrity and potency middot Maintain the right temperature required middot Protect from excessive humidity middot Keep medicines away from direct sunlight middot Protect from pests and rodents

b) Physical location middot Should be easy to locate middot Accessible middot Orderlysystematically placed

2 2 D i f f e r e n t p a t t e r n s o f s t o r a g e The pharmacist could follow any of the different patterns of storage The pattern of stora ge should be selected in such a way that it facilitates speedy and efficient dispensing of medicines

The pattern of storage could vary with each pharmacy experience usual practiceroutine of staff and the person-in charge and also depending on space av ailable turnover etc (i) The medicines could be stored c o m p a n y w i s e ie the medicines manufactured by one company should be grouped together and kept in one place Within each company shelfshelves the medicines may be placed in alphabetical order for easy and quick placement and removal Also bottles tubes boxes etc may be segregated within that shelf

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(ii) The medicines may also be stored in a lphabe t ic al o r de r ie they are placed in order from left to right based on their name The first letter of the name is used to g r o u p t h e m e d i c i n e s t o g e t h e r a n d k e e p t h e m i n o n e l o c a t i o n I n s o m e p h a r m a c i e s a l l t h e strip packing are placed in drawers or boxes in alphabetical order each box or drawer containing strips of one particular alphabet This system ensures that the strips always remain e n c l o s e d i n t h e b o x e s d r a w e r s a n d a r e n o t e x p o s e d t o d u s t T h e d i s a d v a n t a g e i s that it might lead to mix -u p o f strips in the same drawer and it may cause a problem incase of similar looking strips in which case a wrong medicine may be dispensed Secondly cut strips lying around in the drawer may lose their identity if the batch n u m b e r andor expiry date is not seen on the cut portion of the strip

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(iii) The medicines may be stored according to their therapeutic class ( e g a n t i b i o t i c s anti asthmatics or anti hypertensives) ie the medicines are kept together based on their pharmacological or therapeutic action

(iv) The medicines may be stockedsegregated according to dosage forms eg l i q u i d s (bottles) solid oral dosage forms eye drops rotacaps ointments etc all stored on separate shelves

Always Remember I Storage of prescription medicines should preferably be separate from OTC medicines OTC medicines especially those that a r e a d v e r t i s e d m a y b e d i s p l a y e d f o r c l i e n t s t o select or to ask questions about [OTC-O v e r t h e c o u n t e r ] II Storage according to temperatures is a must no matter which pattern of storage is followed Also within a particular storage area segregated storage may be maintained In a refrigerator for example medicines may be stored in trays racks and the freezer according to the temperature required

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Whatever pattern of storage is selected all the personnel should ensure that middot The stocks are stored in an orderly manner middot The medicines are kept back in the same place from where they were removed middot All medicines are arranged neatly once in a while

middot The personnel should be careful while storing the medicines middot They should not throw the medicines haphazardly 23 Different means of storage

middot Within each temperature and security zone medicines must be stored so that they are easily accessible and protected against damage

middot Basic means of storage include shelves racks and drawers middot To prevent dust from entering the shelvesracks it is ideal to have glass

shutterssliding glass doors This can however be disadvantageous because accessibilityspeed is hampered in removing a product from the shelf because the glassshuttersliding glass has to be

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opened m o v e d e v e r y t i m e a p r o d u c t h a s t o b e p i c k e d u p U s e o f a i r c o n d i t i o n e r s f o r t h e p h arm acy with a closed door at the e n t r a n c e o r a n a i r c u r t a i n c a n r e d u c e t h e d u s t problem In such cases the shelvesracks may be left o p e n

bull

middot Direct storage of cartons on the floor should be avoided because besides being an unhealthy practice the contents may also be damaged by moisture bull

middot Store medicines preferably in shelves with glass shutters for visibility middot Closed shelves further prevent dust from going in especially in India where most

pharmacies are located along busy roads middot Some medicines have to be refrigerated or stored in a cool or cold place Having a

refrigerator or two (as per the need of the pharmacy) is essential to store suc h medicines at temperatures mentioned on the label bull

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Refrigeration middot All cold chain equipment should meet required standards middot Improvement in refrigeration technology has provided frost -free refrigerators

Pharmacists should opt for frost-free refrigerators as they are easy to maintain and protect printed packaging materials Conventional refrigerators may cause water falling from trays below the freezer on medicines stored in the refrigerator thus causing soggy labels

middot bull Frost-free refrigerators also provide separate and large compartments for the freezer portion (required for storing medicines needing sub-z e r o t e m p e r a t u r e ) and the main storage area with separate doors so that opening one door does not disturb the storage temperature in the other compartment

Care should be taken to keep the refrigerator on 24 hours a day It should not be switched off after working hours It is advisable to have an inverter connected to the refrigerator so that the refrigerator re mains working even when there is a power outage

middot The refrigerator door should be closed tightly middot The refrigerator door should not be left open for too long middot Space should be left between medicines stored in a refrigerator to allow air to

circulate middot The ref rigerator should be placed about an arms length away from the wall

This will increase air circulation thus not affecting the cooling within the refrigerator

middot Vaccines should not be stored on refrigerator door shelves as they are exposed to warmer temperatures each time the door is opened Vaccines should always be stored on the middle shelves of the refrigerator

middot Refrigerated medicines should not be left out of the refrigerator for more than a few minutes

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middot Consumable products like juices energy drinks e t c s h o u l d n o t b e s t o r e d a l o n g with medicines in refrigerators If required they may be kept in a separate refrigerator

middot An adequate number of refrigerators should be planned to store the entire stocks requiring refrigerated storage

middot Adequate procedures should be followed for defrosting cleaning and maintenance of refrigerators

middot Icefreeze packs should be kept in the freezer compartment so that they can be used for transporting cold temperature medicines The packs can be given to clients along with the medicines requiring cold temperature storage so that the temperature is maintained till the client reaches home and can then put the medicines in a refrigerator) Freezer packs can also be used to keep medicines temporarily in case there is a power outage or refrigerator breakdown

Activity

Prepare a SOP (Standard operating procedure chart) for cleaning a refrigerator Discuss it with your staff finalize its maintenance once a month through AMC -A n n u a l Maintenance contract CMC - Comprehensive maintenance contract and put it up on the pharmacy refrigerator Put the Purchase Order details name of manufacturer Phone of Service Engineer and a register to login the Machine service and down timeService reports may be maintained properly

Refrigerator monitoring and maintenance

middot bullIt is important to carry out routine monitoring and maintenance of the refrigerators and to organize an effective repair system

middot bullThe temperature in the refrigerator must be monitored and recorded routinely at least once a day

middot Any breakdown must be reco rded including the period during which the medicines were exposed to uncontrolled temperatures Medicines may then be kept or discarded depending on the problem guidelines or the manufacturers advice

middot Cold chain monitor cards and devices in or on packages that change color or otherwise alert staff to potential damage assist in monitoring (These are likely to be introduced in India soon)

middot It is essential to have a contingency plan in place before a refrigerator breaks down An arrangement can be made to move the contents to a private refrigerator elsewhere in the community or to obtain a regular supply of ice packs until the defect is rectified

Put filled water bottles in the bottom half of the refrigerator door in order to provide cooling in the refri g e r a t o r w h e n t h e r e i s a p o w e r o u t a g e T h i s m i g h t t a k e c a r e o f t h e temperature when there is no current for a couple of hours If the power outage is expected to last for several hours special arrangements such as an inverter UPS have to be made to keep the refrigerator constantly running in the absence of electricity middot Defrost the refrigerator in case of excessive ice formation and preferably at regular

intervals Keep a record of the same

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2 4 T e m p e r a t u r e c l i m a t i c c o n d i t i o n s

i) Temperature control middot The medicines in a pharmacy need to be stored at appropriate temperatures to

maintain their stability middot An air-conditioned environment where temperature can be controlled is

recommended for pharmacies Air conditioning offers the option of setting the t e m p e rature as per requirements

middot bullIt is ideal to have an air conditioner to maintain the temperature below 25 C as most medicines require storage below this temperature Secondly this temperature is pleasing to both the staff and the visiting customers too

middot In the absence of an air conditioner circulating fans may be used middot This need is felt even more in certain parts of India where temperatures soar above 45

C and some areas where it falls to sub zero temperatures In such cases temperature maintenance is essential to prevent deterioration of medicines due to unnecessary exposure to drastic temperature fluctuations

middot This need is felt even more in certain parts of India where temperatures soar above 45 C and some areas where it falls to sub zero temperat u r e s I n s u c h c a s e s temperature maintenance is essential to prevent deterioration of medicines due to unnecessary exposure to drastic temperature fluctuations

i i ) Humidity or moisture control Moisture or humidity can adversely affect the stability of me dicines such as tablets capsules powders

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Gelatin capsules become soft and swell on absorption of moisture The drug content of tablets may undergo surface hydrolysis The presence of moisture may encourage the growth of microbes It is therefore essential to control humidity

To reduce the effect of humidity the following suggestions may be followed -middot Open the windows to allow air circulation Use a fan to circulate fresh (outside) air middot In humid climate a dehumidifier is useful for preventing mo i s t u r e d a m a g e ( i n t h e absence of an air conditioner) middot For bulk containers of tabletscapsules do not keep the container open for a long time and replace the lid or closure immediately after taking out the required number of medicines for dispensing middot Do not allow the medicines to touch the floor or the walls The walls may be damp and may cause moisture absorption damaging the product

middot Calibrated thermometers and manometers can be used to detect temperature and humidity in the pharmacy

middot Periodici t y of checking the temperature should be fixed middot The climatic conditions should be recorded and documented middot Temperature charts should be available for ready reference

Documentation is one of the core activities for achieving and maintaining quality It is one of the most essential components of validation Temperatures in various areas

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including refrigerators should be recorded at a predetermined periodicity usually daily at the hottest time of the day and such documents should be preserved i i i ) Storage conditions A number of storage conditions are mentioned on the labels of medicinal products These conditions have to be properly interpreted and appropriately complied with

According to the Drugs and Cosmetics Rules 1945

1 The term cool place means a place having a temperature between 10 C and 25 C

2 The term cold place means a place having a temperature not exceeding 8 C In case of storage conditions for specific products please refer to Schedule P The Drugs and Cosmetic Rules 1 9 4 5

The Indian Pharmacopoeia specifies the following storage conditions -

Wherever the condition for storage is not specified medicines may be stored under normal temperature In a country like India however where normal temperatures soar to h i gh temperatures it is recommended that medicines be stored in a cool place

Activity Prepare a list of the storage requirements mentioned on the label of about 20 products in your pharmacy and check if the temperature is maintained

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25 Special Storage o f s u p p l i e s If the product has no special instructions normal storage conditions apply This means storage in dry clean w e l l -ventilated premises at temperatures of +15 C to +25 C or depending on the climate up to +30 C (WHO1990) Storage instructions are product specific Different brands of the same generic drug may have different storage requirements as they may have different packaging or formulations It is essential to follow the product manufacturers storage instructions to the maximum extent possible Less stable medicines must be stored in specific conditions to maintain their quality or potency

The following products require special storage facilities

middot Products that must be kept frozen (usually vaccines and sera) middot Products sensitive to h eat an d r e q uir in g r e f r ig e r a tio n ( +2 C to +8 C) middot Products that have reduced shelf life at uncontrolled room temperature and need

mechanical ventilation or air conditioning middot Flammable products that require separate fireproof premises middot Products prone to theft o r m i s u s e

Products needing storage in a controlled environment -

The usable shelf life of the following products may be reduced if stored at uncontrolled humidity or at room temperature in hot climates -

middot Some injectables (eg adrenaline) Most injectable preparations are less stable than solid oral forms (tablets and capsules) Injectable preparations in solution are particularly unstable Many injections must be protected from light as well as heat

middot Intravenous fluids (particularly if packed in p lastic containers) middot Some suppositories pessaries creams and ointments These products may melt at

temperatures greater than 30 C Once this happens it is not advisable to use them because the active ingredient in the formula may get unevenly distributed

middot Products containing rubber latex cellulose or some plastics Condoms most sterile disposable medical devices and surgical products such as syringes needles and catheters require protection from excessive humidity and strong light and heat Any o f these conditions may make products brittle stained amp unusable Sterility cannot be assumed if packaging is damaged

In hot climates these products should be stored in the coolest place possible preferably with air conditioning or air circulation fans

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Products needing freezing or refrigeration-middot Vaccines blood products and many other medicines lose potency if kept even for a

brief period at temperatures outside the recommended range For these products the cold chain must be maintained at every stage of the distribution system

middot Freezing is as damaging as high temperatures for some products including injectable contraceptives ergometrine insulin adrenaline and the DPT DT TT and Hepatitis B vaccines Such products therefore sho uld not be allowed to freeze (not be kept in the freezer compartment)

middot Short periods at room temperature (during transportation or local distribution for instance) may be acceptable for many products (such as ergometrine a n d i n s u l i n ) e v e n t h o u g h s u c h e x posure can to some extent reduce shelf life Other items such as vaccines should always be transported in cold boxes

Storage of insulin injections-

middot Insulin should always be stored in a refrigerator at the recommended temperature of 2 -8 C

middot Insulin should not be kept in the freezer compartment of the refrigerator middot Insulin should ideally be stored horizontally middot It should not be exposed to sunlight or excessive heat middot Insulin suspensions should not be used if the suspension cannot be properly

resuspended due to cake or clump formationbull

Controlled drugs -Narcotics (for example Pethidine injection morphine preparations) and other specified drugs that may be abused are governed by special legislation and regulations The following security measures are suggested in the pharmacy -middot A safe or reinforced double locked cabinet fitted with a light (preferably with a red

bulb) that comes on when the door is opened

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middot A special register recording details of each receipt or issue with 2 signatures physi cal counting of medicines after each entry and signatures at handover takeover

middot Independent audit (by supervisors and drug inspectors)

Products prone to theft abuse or misuse -

Some medicinesproducts are particularly prone to theft abuse or misuse These include expensive medicines (eg insulin) certain antibiotics and products prone to abuse or misuse like psychotropics etc

Such medicinesproducts should be stored adequately They require stricter record keeping and more frequent stock taki ng than others Periodic audits should be carried out to check for consumption against actual recorded use (registers prescription records stock records etc) to expose any theft or misuse bull26 Storage and stability of medicines Medicines are not stab le indefinitely They are stable for a specific period of time sometimes for a brief period Poor storage conditions accelerate the drug degradation (decomposition) Temperature light and moisture are the most important contributing factors for drug instability It is important to identify and be aware of the potential for instability There is a need to comply with storage requirements to ensure quality medicines for patients It is also important to offer advice to patients too about appropriate storage o f medicines at home The dispensing label should state the storage condition required and be backed up by a verbal reminder especially where special storage is required bull

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In case stability and storage problems are seen with formulations they should be reported immediately to the representative of the manufacturer and taken out of circulation till the stability problems have been resolved

The pharmacist can easily detect stability problems when products show change in appearance color odor settling of the product contents breaking of emulsions melting of creams oozing of contents from the containers and any such physical changes

3 STOCK CONTROL AND EXPIRY MONITORING 3 1 S t o c k C o n t r o l For economic reasons pharmacists do not like to have stock on their shelves for long periods of time The aim should always be to keep stock at a level that will just meet demand Normally most manufactured medicines have a long shelf life Even then it is essential that there is efficient stock rot ation so that the older stock is used first It is also a good practice to check the expiry date as an integral part of the dispensing process When short shelf life products are involved stock levels may have to be modified to prevent medicines regularl y expiring on the shelves

32 Stock rotation and expiry monitoring In order to avoid accumulation of expired and obsolete stock medicines should be stored and issued according to the following guidelines -middot The stock control system must record the ex p i r y d a t e a n d t h e d a t e o f r e c e i p t middot Stock must be stored so that earliest expiring batches are picked and issued first middot The First In First Out (FIFO) system - In this system the stock which is received

first is sold first This system however may not be useful for pharmacies because most of the stocks carry an expiry date For pharmacies the FEFO system is more practical

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middot The First Expiry First Out (FEFO) system - In this system the stock having an earlier expiry is sold first The stock with longer shelf life should be placed farthest to the back (or at the bottom in case o f sta c k e d b oxe s) T h is is pa r tic u la r ly impor ta n t with products that have short shelf lives such as vaccines some vitamins antibiotics etc and reduces losses due to expiry

middot E x p i r y dates should be noted on the stock record upon receipt Stock nearing expiry should not be accepted unless it can be used before expiry

Computerization and expiry monitoring In the pharmacy computerization facilitates both checking stocks and expiry mo nitoring and helps-bullbullKeeping a check on products nearing expiry bullbullKeeping a check on non- moving and slow moving products bullbullTo facilitate the removal of medicines nearing expiry from shelves in time to send them back to the wholesaler or supplier

Periodic checking for expiry The expiry date for medicinal products is a critical aspect in pharmaceutical dispensing and due importance should be given to it Periodic checking for expiry of medicines will ensure that the patient will never receive products that have crossed their expiry date During periodical checking of expiry the personnel involved should remove medicines that are nearing expiry bullbullIn -house threshold periods should be set and followed for retrieval of such medicines from the shelves bullbullSuch medicines should be stored separately These should either be dispensed immediately (thus ensuring that they are used before the expiry date) o r t h e y s h o u l d b e returned to the suppliers bullbullA separate area should be designated (cupboard or shelf)marked[FROZEN ZONE] which is adequately marked EXPIRED GOODS- NOT FOR SALE to store all expired stocks FROZEN ZONE

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Remember Expired medicines are a NATIONAL WASTE So stock only what you can sell Avoid expiries save precious medicines for the nation

Treatment and disposing of expired medicines bullbullProcedures need to be in place for the treatment of expired medicines bullbullThe expired medicines need to be collected and be sent back to the supplier or company for appropriate disposal bullbullRecords must be maintained for expired medicines and how they are disposed off bullbullIn case of medicines that are not returnable to suppliers procedures for disposal need to be followed by the pharmacy in conjunction with the FDA The following procedure can be followed if medicines cannot be returned to suppliers ( T h e b a s i c p h i l o s o p h y of appropriate disposal is to prevent their re- circulation and use) bullbullC u t t h e c o n t ainer in such a manner that the label is also cut In case of tablets and c a p s u l e s d e s t r o y them by disposing them in a bucket of water bullbullUse landfill procedures (deep burial into the ground as per stipulations of Medical Waste Disposal Act prevalent in the respective state) bullbullPour the liquids into the sink and wash away with sufficient quantity of water bullbullKeep a record of such disposal with full details of medicines destroyed Although these measures are usually adopted care has to be taken with such tr e a t m e n t a s studies have shown that flushing of medicines has resulted in tracessmall quantities of medicines being found in waterways and groundwater having potential health and environmental effects

4 O T H E R A S P E C T S 41 Design of storage areas The following important factors need to be considered in design of storage areas -middot The retail outlets in hot areas in summers should be air-conditioned Similarly in

a r e a s o f e x t r e m e c o l d t h e p r e m i s e s w o u l d r e q u i r e w a r m i n g e s p e c i a l l y i n w i n t e r s t o maintain cool temperatures The placement of air -conditioners and heating devices should be such that medicines are not directly exposed to the cold or heat

middot Due consideration should be given to storage requirements of formulations while designing shelves and cupboards in retail outlets Sufficient shelf height should be provided so that all liquid products can be stored vertically As far as possible the shelves should be covered with glass panels to protect medicines from dust and p r e v e n t r a p i d f l u c t u a t i o n s i n temperature

middot Medicines should be stored according to the storage instructions on the labels bullIt is ideal to have a door at the pharmacy entrance to prevent dust from coming in as well as reduceprevent cooled air from going out This may not however be considered feasiblepracticable by many pharmacy owners for fear that clients may not enter the pharmacy because the door may act as a barrier An air curtain is a good alternative to a door

middot There should be minimal direct sunlight falling on the products Particular consideration should be given to premises directly facing the sun

middot bullThe arrangement of lighting in the interior of the premises should also be in a manner that the lights are not focused on the products It has been shown that light causes not only chemical damage but also can catalyze physical changes like moisture uptak e by the products Care should be taken to ensure that only diffused light falls on them

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middot As far as possible provision should be made for a temperature and humidity indicator device in a pharmacy These devices are now easily available

middot Stability studies o f m e d i c i n e s p a c k e d i n b l i s t e r s h a v e r e v e a l e d t h a t i f t h e s e a r e exposed to light they tend to absorb moisture It is therefore necessary to store them in suitable cartons so that the blisters are not exposed to light Pharmacists should do this even if the manufacturer has not provided cartons

middot Light and temperature sensitive products should not be stored on counters where the light is intense or direct and there is no protection from temperature and humidity

42 Cleaning and maintenance i) Cleaning of storage areas

The storage areas of the pharmacy should be cleaned periodically and cleanliness should be maintained at all times The Standard Operating Procedure for cleaning should be designed and followed accordingly Schedules for cleanups should be laid down and adequate cleaning equipment should be made available

Tips for maintaining cleanliness middot Provide clean pieces of cloth for wiping at various locations in the pharmacy

Replace with clean cloth at regular intervals middot Keep separate pieces of cloth for floors shelves and medicines middot Use a disinfectant andor soap solution to clean floors middot Ensure removal of dust and prevent accumulation of dirt middot Ensure removal of cobwebs middot Use a vacuum cleaner for cleaning areas not easily reachable middot T a k e c a r e t h at breakages are handled and cleared effectively middot Observe the factors leading to waste generation in the pharmacy and take appropriate

measures to tackle the problem middot Record all cleaning procedures performed and maintain all the documents required

For ex a m p l e -bullbullThe floor of the pharmacy may be swept with a broom and swabbed with soap water every morning bullbullThe floor may be swabbed with a disinfectant every week bullbullThe entire premises including shelves and cupboards may be cleaned with a cloth (to remove dust and to check for medicines approaching expiry date or expired medicines) every three months bullbullAll the steps followed should be r e c o r d e d

The floor shelves drawers have to be cleaned and a check should be kept on dust cobwebs spillages due to breakage etc It is therefore essential to have SOPs for cleaning laying down cleaning frequencies allotting responsibilities and maintaining a daily record in the logbook to document all these activities

54

While cleaning dust settled on dosage forms like bottles tubes etc should be removed Before dispensing the products should also be wiped to remove any dust settled during storage

For refrigerators bullbullDefrosting and cleaning should be done at regular intervals bullbullSwitch off the refrigerator while cleaning bullbullCleaning should be done quickly and stocks put back immediately

i i ) Pest control Pests are a serious problem in India where insects reptiles and rodents (eg cockroaches l i z a r d s r a t s s i l v e r f i s h (Deemak - in Hindi ) etc) may find access to the pharmacy storage areas Insects like ants and borer ants may often attack wood in the pharmacy causing d am ag e to shelves cupboardsPest c ontr o l in a p h a r m a c y c a n b e a d i f f i c u l t t a s k b u t t o avoid possible contamination and physical damage to stock it is necessary to keep pests out of the pharmacy premisesPest control measures should be implemented with proper p r e c a u t i o n s t a k i n g u t m o s t c a r e t o a v o i d contamination of medicines

55

Th e following pest control measures c a n be ta ke n f r om tim e to tim e -bullbullRat bait and traps can be placed at various locations bullbullInsecticutors can be used on a permanent basis bullbullInsecticidal sprays and repellants can be used from time to time

i i i ) Fire precautions

Combustible trash such as cartons boxes and other packing waste must not be allowed to accumulate in the store Waste should be deposited in appropriate waste bins and be d i s p o s e d o f f o n a d a i l y b a s i s

F i re detection and fire fighting equipment must be maintained and regularly inspected The pharmacy personnel should receive adequate training in fire fighting techniques and emergency actionFire prevention measures should include a prominently displayed ldquoNoSmokingrdquo sign careful handling and disposal of combustible waste materials and checking of electrical connections at regular intervals

iv) Security middot Doors shutters of the pharmacy should be strong and be fitted with secure locks middot Counters should be designed so that unauthorized personnelclients do not have

access to areas where prescription medicines are stored Access to such areas should be restricted to the pharmacy staff

middot All the pharmacy staff handling supplies should be accountable for their ac t i o n s

56

middot bullSpecial care must be taken in case of Schedule X and manufactured drugs (under NDPS Act) Such medicines should be kept under lock and key and the key should be kept with the Chief Pharmacist or i n h i s a b s e n c e t h e s e n i o r p h a r m a c i s t

v) Breakagespillage and damaged product Products that have been damagedspoiled during storage and handling spillages and broken glassware should be disposed off according to procedures laid down by the pharmacy Broken and damaged products s h o u l d b e p l a c e d i n a segregated area to be returned to the supplier

vi) Inspection Senior staff should inspect all pharmacy areas regularly The shelves and drawers should b e c h e c k e d d a i l y f o r signs of pests and dust Ceiling and walls should be checked for dirt and cobwebs Stock should be checked on a regular basis for deterioration due to climatic conditions

43 Product recalls Products found to be defective should be quickly recalled (withdrawn from the market) The instructions are generally issued either by the manufacturer or the regulatory agency The level of recall is determined by both the degree of risk and the extent of distribution of the product and in India is mainly directed at the distribution chain

On receiving the details of the defective substandard spurious batchbatches of a medicine to be recalled from the manufacturer or the stockist or the FDA the pharmacy should immediately check if the particular b a t c h i s i n s t o c k a n d i f s o s u s p e n d i t s s a l e immediately

Similarly if the regulatory authority in the country bans a particular medicine or FDC the pharmacy should immediately check and remove all the different brands of that particular medicine under consideration

The details of medicines and their batches to be recalled should be available in the q u a r a n t i n e a r e a w h e r e stocks are received and checked This is to ensure that such medicines do not come into the pharmacy

middot The pharmacy should develop SOPs for recall of medicines middot The pharmacy staff should be immediately informed about such medicines and

the details should be displayed in writing in a prominent place in the pharmacy middot Rapid action helps avoid unnecessary exposure to such medicines once the

problem has been d e t e c t e d middot The progress of the recall procedure in the pharmacy should be monitored every

few days to ensure complete compliance middot All stocks of the recalled products should be stored separately from the saleable

stock These can be stored in the expiry cupboard segregated from the expired goods and be appropriately labeled ldquoRecal l e d G o o d s - Not for Salerdquo

The supplier should be notified and asked to replace defective products middot All the details of the procedures followed should be duly recorded in a Recall

Register maintained specially for the purpose The register should include d etails such as -middot Date of the recall middot Nam e of the product

57

bullbull

middot Details of the product (name of manufacturer batch number expiry date) middot Nu m b er of units purchased sold a n d sto c k in ha nd middot Reason for recall middot Nam e of the supplier to whom produc ts w e r e returned along with the date and quantity middot Name and signature of the designated personnel carrying out the recall procedure and recording details middot Name and signature of the chief pharmacist verifying the recall procedures and recording details 4 4 Returned medicines

Medicines may be returned to the pharmacy by clients due to the following reasons -bull

bullbull Unused medicines bullbull Course not completed bullbull Therapy changed by doctor bullbull Side effects experienced by patient bull

bullbull DamagedDefective medicines bullbull Missing or defaced label bullbull Missing tablets in a stripblister bullbull Leakage in bottles bullbull Leakage in strips bull

bullbull Expired medicines

Appropriate SOPs should be framed and followed for their acceptancerefusal and disposal middot bull For unused medicines returned by clients the p harmacy personnel should verify

that these were purchased from their pharmacy They should then be checked for integrity of the packing the dosage form and the expiry date and verified with the client whether they were stored in appropriate conditions This again is at the discretion of each pharmacy

middot The damageddefective medicines returned to the pharmacy should be taken back and stored separately Existing stock of the same product should be checked for similar defects

middot Expired medicines should be accepted from clients at the discretion of the pharmacist and be immediately shifted to the expired goods cupboard These can be stored segregated from the pharmacys own expired goods and be appropriately labelled ldquoExpired Goods returned by clients- Not For Salerdquo

It is advisable not to accept returned medicines requiring cold chain storage (refrigeration) because it cannot be ensured that the cold chain was maintained when the medicines were in the hands of the patientclient middot Appropriate adjustments in t he stocks should be made for medicines

returnedexchanged to update the inventory middot The medicines should then be returned to the respective shelves middot A lsquoReturned Goodsrsquo register needs to be maintained to record all details of returned

medicines

R egister should include such details as-

58

middot N a m e o f t h e p a t i e n t middot Nam e of the product and quantity r e tu r n e d middot Product details such as the batch number and expiry date middot Condition in which received middot Reason for returning products middot Compensatory measures taken wi t h r e s p e c t t o c l i e n t middot Action taken with respect to product middot Name and signature of the personnel accepting the returned medicines and recording details middot Name and signature of the chief pharmacist verifying the recorded details

What the pharmacist would have learnt from this module The storage of medicines is a critical factor in the distribution cycle bullbull Stocks received by the pharmacy should be quarantined in a separate area and necessary checks s h o u ld be performed to ascertain the qua lity a nd quantity of stocks received bullbull Whatever pattern and means of storage used the products should be stored so as to maintain their potency and integrity bullbull Storage conditions should be monitored and maintained on a regular basis bullbull Optimum stock levels should be maintained and regularly monitored for expiry bullbull The design of storage areas should facilitate appropriate storage of medicines bullbull Cleanliness should be maintained in the pharmacy bullbull Adequate measures should be taken in case of returned medicines and recalled products

Optimum storage of medicines is mandatory whether at the distribution stage at the pharmacy or ultimately within the homes of patients The pharmacist has an important r o l e t o p l a y i n t h e s t o r a g e o f m e d i c i n e s i n m a i n t a i n i n g d r u g p o t ency and efficacy and thus facilitating optimum therapeutic benefits Good Pharmacy Practice - IPA -CDSCO - WHO Appendix I Quality Assurance Templates of letters for use if found not of Standard Quality [Frozen and expired goods ]

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated To Name of the Supplier with address

Sub Not of Standard Quality GoMP-Supply of Drugs and medicines-(Codename) Return of Stocks to the Suppliers-reg(New drug policy 2009) Previous letterinvoice ref Sl No Drug Code Drug name

Manufacturing date Expiry date

Supplier address

B a t c h n o

The above items of PO nodated was drawn by the Drug Inspector (Place) on (______________date) as a statutory sampling and declared ldquoNot of Standard

59

Qualityrdquo on -(______________date) by the Government Analyst for the following reasons

- ldquoThe product sample do not confirm to IP specification for (Drug codename with respect to the content of drugrdquo

- ldquoThe product has already been blacklisted by TNMSC on -(______________date) for the failure of (quantity) of batches of drug codenamerdquo

As per the clause of the te nde r d oc um e nt ldquo I f the sa mple s d o not c onf o r m to statutory standardsthe tenderer will be liable for relevant action under the existing laws and the entire stock in such batch should be taken back by the tenderer within a period of 30 days o f t h e r e c e i p t o f t h e l e t t e r f r o m t h e v e n u e

The stock shall be taken back at the expenses of the tendererthe Procurement Authority have the right to destroy such Not of Standard Quality if the tenderer does not take back the goods within the stipulated time

The Procuring Authority will arrange to destroy the Not of Standard Quality drugs within 90 days after the expiry of 30 days mentioned above without further notice and shall also collect demurrage charges calculated at the rate of 2 per week on the value of the drugs rejected till such destructionrdquo

Hence we regret to inform you that you will have to take back the stocks available of the abovesaid batch at your own cost from the drug stores where you have supplied the above batch

Kindly acknowledge the receipt of this reference at once

P r o c u r e m e n t A u t h o r i t y Seal and Stamp

Copy to Ref No dated

1 ) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated13082010

To

Sub Frozen Drugs-ordered to return to the Suppliers-reg(New drug policy 2009) Previous letterinvoice ref

The following products which were earlier frozen have now been ordered to return to suppliers directly with permission from the State drug Authority In this regard the suppliers have been instructed to take back their failed batch from the drug store of the stores Hence you are now instructed to return the following failed batches to the suppliers by obtaining proper authorization letter and acknowledgements from them

60

Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

Kindly acknowledge the receipt of this reference at once

Procurement Authority Seal and Stamp

Copy to

Ref No dated 2) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated14092010

To

Sub Frozen Drugs-ordered to return to the Suppliers- for issue of gate pass after verification reg(New drug policy 2009) Previous letterinvoice ref

The following products which were earlier frozen have now been released Hence they may be issued Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

Kindly acknowledge the receipt of this reference at once

Procurement Authority Seal and Stamp

Copy to

61

Ref No dated 3) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated

To

Sub Stop instruction-reg(New drug policy 2009) Previous letterinvoice ref

Until further instructions stop issue all the batches of the following item Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

You must intimate the available stock in the stores of the said batch Number to the Procurement Authority immediately Also retrieve quantity if already issued

Procurement Authority Seal and Stamp

Copy to

Ref No dated 4) HOD Procurement Office of

62

Appendix II Material handling in drug stores

Rack approx rates and dimensions

S No

Item Description UOM Approx Rate

1 MEDIUM DUTY RACK SIZE 2900 H X 3090 W X 800 D IN MM (AS PER SPECIFICATION)

Each 2499800

2 MEDIUM DUTY RACK ADD ON UNIT FOR SIZE OF SR NO2

Each 2243100

To locate a Box no 3 Rack no 14 in row3

SAMPLE OF RACK no Bin numbering -------------- S a y R K 1 4 R o w 3 B o x 1 6

SAMPLE LAYOUT of RACKS in a Drug Stores

63

Sample of another warehouse of distribution warehouse system

64

65

Slotted Angle racks with bin cards

66

Plastic Pallets

Plastic pallets ar e l i g h t w e i g h t l o w- c ost and exceed industry standards for strength and durability

NOTE A pallet has bottom deckboards (see sketch) A skid does not have bottom

67

deckboards

Battery Operated Stacker

Electric Stacker Ehh (Manual Push Type) - Manual drive - Lifting electrically with Battery 12 V 88 Ah - For loading and un-loading of trucks - Battery and loading device built - in - Battery charge gauge and charging current gauge Simple and Easy Operation - Lifting and Lowering electrically direct on steering arm - Pulling and pushing through steering arm - Electrically operated relief valve on hydraulic aggregate Safe Operation - Emergency Off Switch - Constant lowering speed - Protection through lowering brake valve - Overload protection through overload brake valve - Load chains covered preventing pinching threat - Electrically interlocking during loading process - Secured battery compartment opens upwardly - Stable buffering of the steering arm in upright position - In accordance with EWG Guidelines 89 240 - In accordance with VBG 12b Prevention of Accidents

Pallet Truck [ Top ]

68

----------------------------------------------------------------------------------------------------------------------------

For Transport Of All Goods On Pallets Safe and Easy Operation - through single hand operation Lifting moving

lowering with steering handle - neutral position of the hydraulic possible - overload pressure relief valve Long Service Life - robust co n s t r u c t i o n

- special hardened axles - hardened chromium plated ram - maintenance free Easy Maneuverability - through rubber steering rollers - nylon fork rollers

A h a n d t r o l l e y

69

Trolley with plastic bins for several items del ivery

70

Digital Weighing balances

Balances amp Scales EF Seriers Precision Electronic Balance

71

1

Ice lined Refrigerators

600 litres refrigrator

72

Walk in cooler

vacuum cleaner

73

X HOW TO INDENT

(a) The ward Section -i n - c h a r g e s h o u l d e n s u r e t h a t t h e s t o c k s u n d e r t h e i r c h a r g e a r e not unnecessarily large and only a realistic quantity is indented once a week

( b ) The indent should not be made out in the names of the patients or by bed numbers The indent should be for the Wardsection as a whole

XI KEEPING OF RECORDS IN WARDS AND SECTIONS

(a) A set p r o f o r m a ( A n n e x u r e E ) s h o u l d b e u s e d i n t h e w a r d s e c t i o n f o r s h o w i n g u p receipts and issues Balance of expenditure for each item to be drawn out every morning by nursecompounder in charge before writing out the Indent or before restarting work The medica l O f f ic e r r e side nt in c ha r g e sh ould a tte st th e e ntr ie s after satisfying himself- by random checking at least once a week

( b ) To support the above mentioned expenditure the Bed head Tickets (treatment charts) are very important Each medicine prescribed should be legibly written indicating the total quantity prescribed if the medicine is to be deleted from treatment the fact should be mentioned as to how much of the drug was issued to the patient before switching on to another drug The suggestion is that a separate treatment card be maintained for each indoor patient ( Annexure ndash G) A summary s h o w i n g t h e t o t a l a m o u n t o f t h e p r o p r i e t a r y d r u g s c o n s u m e d b y t h e p a t i e n t d u r i n g is hospital stay be worked out and noted in the summary card

XII ACCOUNT ABILITY OF DRUGS BROUGHT BY THE PATIENT OR RECEIVED IN DONATION BY THE WARDSECTION _IN -C H A R G E

The drugs receoived from the non - governmental sources should be entered on the receipts side of the WardSection Sto c k b ook a n d issu e s to show n a s in th e o the r cases on the issues side

XII RSPONSIBILITY OF STORES AT VARIOUS LEVELS (a) The head of the institution shall be held responsible for non-observance of

rulesprocedures laid down by the Government ( b ) The Medical officerresident in charge of the stores and the store keeper shall be

held responsible for any irregularity found in the stores or for ignoring the ordered pattern of working It shall be the duty of the Medical officer Incharge of the Stores to occasionally check the WardSection Stock-b o o k s t o t a l l y t h e e n t r i e s made in the 3 r d copy of the Issue vouchers [as laid down under V (b)supra ]

(c) The Medical officerresident in charge of the WardSection shall be responsible for irregularities in indenting stocksfor maintaining stocks much in excess of the req uirement and for improper keeping of BED HEAD TICKETS (treatment chartsCards)

( d ) The NurseCompounder ndash i n -charge of the WardSection shall be responsible for shortages in stocks for putting up inflated indents and or for not taking into account medicines b rought by the patientson the WardSection stock-books Heshe shall also be held responsible for ensuring proper distribution of medicines to each and every patient under his her charge

XIV DISTRIBUTION OF MEDICINES FROM OUTDOOR DEPARTMENT (A) ( a ) T h e r e are proprietary and non -proprietary medicines (like mixtures ointments

and lotions) which are to be distributed gratis to patients 14

(b) The Outdoor incharge shall arrange to maintain a stock of common drugs (list of which shall be prepared by the Head of t he Institution) and arrange to replenish the stocks once a week as has been laid down for wards (c) No proprietary drugs shall be issued on the prescription of an intern ( d ) The Head of the institution shall make out a list of drugs which can be issued on

the prescription of a houseman from the Outdoor stock without the countersignature of any other authority

(e) The residents can prescribe any drug from Outdoor stock without the counter signature of any authority

(f) The Consultants can prescribe any drug to any ot h e r o u t e r p a t i e n t e v e n i f i t i s n o t s t o c k e d i n t h e o u t d o o r b u t t h i s s h a l l h a v e t o b e c o u n t e r s i g n e d b y t h e h e a d o f t h e institution for issue from The Main Store

(B) T h e p e r s o n i n c h a r g e o f t h e O u t d o o r m e d i c i n e s s t o c k s h a l l k e e p a r e c o r d o f t h e q u a n t i t y o f t he medicines issued to each patient and instead of writing the name and other details e may only put down the Registration number of the patient and the quantity issued

At the end of the day he must work out the total expenditure of eac item and draw it s balance

The Medical officer in charge of the Stores and the Head of the institution sould check these records at least once a week and affix is signature to confirm their inspection

(C ) No proprietary medicine shall be issued without a valid issue s l i p ( A n n e x u r e- F)

(a) For Housemen the slip would be of brown colour ( b ) For residentsDemonstrators it shall be of pink color (c) For consultants the issue slip should be white ( d ) All issue slips should be printed and pages serially numbered (e) T h e d o c t o r s t o w h o m s u c h i s s u e s l i p s w o u l d b e i s s u e d s h a l l b e h e l d

responsible for their sa f e ke e ping a n d th e y w ould e n su r e tha t th e se slip s would be printed and serially numbered

(f) The doctors prescription slips (for issue from hospitals) of proprietary drugs be prepared in du plicate with the help of carbon One copy should be given to patient for obtaining medicines from the Stores and the other would remain in the Doctors Prescription Slip book

(g) Every issue Slip should be signed and below the signatures a rubber s t a m p s h o w i ng name and designation be affixed The Store people would n o t h o n o u r s l i p u n l e s s t h e n a m e o f p r e s c r i b e r i s c l e a r a n d h i s a t t e s t e d signatures are available to stores

( h ) The Store Staff would file prescription slips of each doctor separately to facilitate the scrutiny at least once a month by the Head of the Institution Such a Scrutiny would reveal over prescribing of or injudicious use of drugs

(C) Proprietary medicines should not be issued for more than three days requirement at a time The only exceptions being cases for cancer pulmonary tuberculosis and leprosy In exceptional cases an officer not below the rank of a Consultant can prescribe for more than 3 days but after the countersignatures of the Head of the Institution

15

XV LOSS BREAKAGE DAMAGE ETC

(A) Any loss of public money departmental revenue of receipts stamps stores or other property held by or on behalf of the Government caused by defalcation or otherwise discovered in an office or institution should immediately be reported by the officer concerned to the head of department through his immediate superior as well as to the Accountant General if the loss exceeds Rs 20000(fig of 1977) (for Proforma see Annexure I)even when such loss has been made good by the party responsible for it Such reports must be submitted as soon as possible and soon after suspicion arises that there has been a loss they must not be delayed while detailed enquiries are made

When the matter has been fully investigated further and complete report should be submitted of the nature and extent of loss showing the errors or neglect rules by which such loss showing the errors or neglect of rules by which such loss was rendered possible and prospects of effecting such recovery

The s ubmission of such a repot does n o t d e b a r t h e l o c a l a u t h o r i t i e s t a k i n g f u r t h e r a c t i o n which may be deemed necessary like handing over the case to the police

Every Government servant should realize fully and clearly that he will be held personally responsible for any loss sustained by the government through fraud and negligence on is part and that will also be held personally responsible for any loss arising from fraud or negligence on the part of any other Government servant to extent to which it may be shown that he has contributed to loss by his own action or negligence

A s s o o n a s s h o r t a g e i n s t o c k o r l o s s i s d i s c o v e r e d a p a r t f r o m r e p o r t i n g t h e m a t t e r a responsible officer should be deputed to investigate the matter

W h e r e t h e r e i s n o l i k e l i h o o d o f a d e l i b e r a t e t h e f t b u t l o s s i s a result of neglect onlythe loss should be made good by the person on whose charge or custody the article lost remained

(B) As soon as damage or breakage of Government property is detected certain steps mentined under should be undertaken-

(a) A p r o m p t t h o ro u g h i n v e s t i g a t i o n i n t o t h e c a u s a t i o n o f b r e a k a g e o r d a m a g e s h o u l d be undertaken by the doctor-i n -charge of the WardSection or by the Head of the Institution

( b ) The investigating officer should draw conclusions as to whether the breakagedamage has been a result of-

(i) C a r e l e s s a n d n e g l i g e n t h a n d l i n g ( i i ) Unpredictable action of the patient for whom the equipment was

being used (iii) Accidental ( i v ) Manufacturing Defect

A report is then prepared in duplicate by person in charge of the article under question on the lsquobreakage and loss proformarsquo (See Annexure H)

16

These reports have to be signed by the investigating officer and are to be then submitted to competent authority for suitable action One copy which is returned is to be kept with the Stock Register In cases where the b r e a k a g e o r d a m a g e i s o f s u c h b i g g e r d e g r e e t h a t s atis factory repairs are not possible a n d if suc h b r e a k a ge o r da m a ge is o f su c h a de gr e e that satisfactory repairs are not possible and if such breakage or damage has been caused-

( i ) B y a G o v t s e r v a n t because of negligent or careless handling cost of the article should be recovered from him and credited to the treasury (ii)On account of reasons mentioned above that is un predictable action of the patient accidental or manufacturing defectthe article could be written offsubject to powers delegated to the concerned for such purpose

(C )Shortages detected during biannual physical verification of the Storeshave to be dealt in a similar manner

(D) it shall be at discretion of the competent authori ty (who is empowered to write off the loss) to reduce the amount of recovery upto 50 of the cost of article provided that before arriving at such a decisionhe has taken into account the following points (a) Normal life span of the article under questi on (b) Period for which it has been in use (c ) Condition of the article at the time of loss or damage and (d) Whether it was on account of careless or negligent act or not

XVI PROCEDURE FOR WRITING OFF STORES

(a) When any Stores become unserviceable otherwise than in ordinary course or by fair wear and tear their value should be treated as loss to the Government and in such cases cost should be recovered from the person responsible for his negligence

( b ) A s t r i c t w a t c h s h o u l d b e k e p t o n t h e m e d i c i n e s w h i ch bear an expiry date and if there is no likelihood of their being utilized locally intimation of the fact should be sent to Directorate of Health services and also to all o t h e r d i s t r i c t s s i m u l t a n e o u s l y s o t h a t t h e y c a n b e p u t t o u s e b e f o r e t h e expiry date In the event such a course is not followed and the Government i s p u t t o l o s s c o s t o f t h e m e d i c i n e i n q u e s t i o n s h a l l b e r e c o v e r e d f r o m t e defaulter

(c) For declaring articles as unserviceable a Committee of three members should be formed in each officeinstitution This Committee should examine each and every article brought before it and should record full reasons for condemning them and also say how the articles condemned have to be disposed of-whether by sale (by public auction) or otherwise

I f t he local Authority is not competent to write off the articles condemned by the Committee it should send the proposal to the higher authority for suitable a c t i o n

17

In Institutions where there is only one doctor a list of articles to be condemned should be p r e p a r e d a n d o r d e r s o n i t b e o b t a i n e d f r o m t h e inspecting authority during inspection

While preparing any list of articles for condemnation details regarding the date of purchase date of receipt period during which it remained in use usual life of the article and its purchase price should be noted against each item

( d ) The condemned articles should not be struck off the Stock Register till the competent authority sanctions its write ndashoff Details of Authority under which the article has been written off should be mentioned in stock register

XVII DISPOSAL OF WRITTEN OFF ARTICLES

Articles like linen should be torn into strips 10cm width so that they could be burnt or given to Government Jails for making carpets

Items like bed -pans bowlsurine po ts etc should be crushed and kept for auction

Brass utensils have also to be crushed to destroy their shape and could be either auctioned or after inviting rates from several dealers could be locally sold to highest bidder

In case when condemned ar ticles have to be sold by public auction they should be stored safely and the Government Auctioneer be intimated In case he expresses his inability to undertake the auction the officer should proceed with the auction departmentally The sale proceeds in either case should be credited to the Treasury as miscellaneous receipts under the Proper head of account

XVIII PHYSICAL VERIFICATION (a) The stocks held by officesinstitutions in various sections should be physically

verified twice a yearin the months o f April and October ( b ) Checking should be done by an officer other than te one who holds the charge of

Stores (c) Verification should be done in presence of officer holding the charge of Stores ( d ) All discrepancies found during the verification should be properly investigated

and accounted for

(j) Any excess detected during verification should be entered in the Stock book as Receipts with the remark ldquo Excess found on verificationrdquo

(ii)any shortage should be noted in issues column of lsquo Issuesrsquo described as lsquoshortage fou n d o n v e r i f i c a t i o n rsquo

XIX ANNUAL STORES ACCOUNT This account should be prepared according to the instruction issued from the department from time to time This should account for the outgoing financial year on the following lines -(a) Cost of the articles under various heads on the last day of the previous

year 18

( b ) Cost of the articles under the various Heads Received during the year (c) Cost of various articles written off during the year under review ( d ) Cost of the articles on the last day of the year or on the firs t d a y o f t h e

financial year following

19

Annexure A WardSection Indent Register No Issued on

Name of institution Page Folio No

Serial no Name of Article Quantity in Stock

Quantity required

Prepared by Approved by Recd by Note-Indenting Officer to sign and affix seal with name and

designation below the last item to avoid additions in one strokeno issues to be made by storesif Issue vouchers of

previous Indent has not been returned back by the WardSection

20

Annexure B Issue Voucher No (printed number)

Supplied to Wardsection Date

Indent no

Serial no Name of Article Quantity in Stock

Quantity required SB No

Stores-in MO Resident in Sign of charge charge WardSection

NurseCompounder Prepared by Recd Approved by by

Note-Indenting Officer to sign and affix seal with name and designation below the last item to avoid additions in one strokeno issues to be made by storesif Issue vouchers of previous Indent has not been

returned back 1st copy-Stores 2nd copy -Wardsection3rd copy-Tobe reurned to sores with Stock book entries

21

Annexure C

STOCK REGISTER FOR DEAD STOCKS

SERIAL NO DATE OF RECEIPT

Article with description

No of pieces Cost Details of

Bill Signature No Disposed

Date of disposal

Manner of Disposal

with Authority

Value realised Signature

1 2 3 4 5 6 7 8 9 10 11 12

P r e p a r e d B y C h e c k e d b y A p p r o v e d b y

Date Designation Name of Institution

22

Annexure D

STOCK REGISTER FOR EXPENDABLE ITEMS Name of article

Date

From where

received with cost

Quantity Signature To whom issued Quantity Balance Signature

1 2 3 4 5 6 7 8

23

Annexure E

Receipt amp Issue Register for WARDSSECTIONS (one or more pages as per requiremnt for each medicine)

NAME OF MEDICINE RECEIPT ISSUE

DATE Quantity In Stock

Date of

Issue

Issued toMention Bed no amp

quantity (in bracket) (For

Outdoor cases give Regd No)

Balance Signature

24

Annexure -F

OUTDOOR FREE MEDICINE SLIP In Duplicate

Name of Patient Registered No Date

Sr no Name of Medicine Quantity

Seal amp sign of doctor

25

Annexure-G

TREATMENT CARD

WARD NO

NAME OF PATIENT BED NO DATE amp TIME OF ADMISSION DATE amp TIME OF DISCHARGE

DATE MEDICINES PRESCRIBED SIGNATURE

26

ANNEXURE -H

PROFORMA FOR BREAKAGE amp LOSS

NAME OF OFFICEINSTITUTION DATE PLACE

SRNO NAME amp

DESCRIPTION OF ARTICLE

COST DATE OF PURCHASE

REASON CAUSE OF BREAKAGE

RECOMMENDATION OF INVESTIGATING AUTHORITY

Signature

Orders of the Competent Authority

Signature

27

Annexure ndash I Loss- Procedure for Reporting

1 The exact nature of the defalcation 2 The full extent of loss 3 The actual period covered by the defalcation 4 The defects in the negle c t o f r u le s by w hic h the loss was rendered possible

and circumstances which facilitated the defalcation 5 The names of the officials held personally or technically directly or

indirectly and wholly or partially responsible for the irregularity c o m m i t t e d i n t h e c a s e

6 Whether the c a s e a s b e e n J u d i c i a l l y t r i e d i n a c o u r t o r n o t i f s o c o p i e s ( i n duplicate) of the Judgment may please be furnished Copy of police report may also be furnished

7 The remedial measures adopted as safeguards against the losses hereafter 8 The prospects of re covery of the loss and he action taken to effect

recovery together with the amount recovered 9 Head of Account to which the Loss is debitable may be informed

Signature of Head of Office with seal

NoteA copy of this report is to be sent to AGMPThis is as per M P Finance Code Vol I

28

STORAGE AND STOCK MANAGEMENT

29

Foreword

The New Drug Policy 2009 is being implemented in the State of Madhya Pradesh

In order to have a proper procedure for Storage maintenance and expiry management of the drugs it is necessary to follow Good Storage Practices with Standard Modules for pharmacistStore keepers

Proper guidelines on Storage Practices can lead to better Stores and inventory upkeep with medicines being properly stored in racks with proper cleanliness and hygiene

This is a step towards storage maintenance and expiry management at the various stores in the state Looking forward to see that the heads of all health facilities take benefit from this module

D ir e c t o r M e d i c a l S e r v i c e s

30

INDEX

Sr No P a r t i c u l a r s P a g e

1 S T O R A G E A N D S T O C K M A N A G E M E N T 4

1 Quarantine and checking of stocks 11 Quarantine area 12 Checks to be carried out on new stocks

2 S t o r a g e 21 Need for proper storage 22 Different patterns of storage 23 Different means of storage 24 Temperatureclimatic conditions 25 Special storage of supplies 26 Storage and stability of medicines

3 Stock Control and Expiry Monitoring 31 Stock control 32 Stock rotation and expi r y m o n i t o r i n g

4 Other aspects of storage 41 Design of a storage area 42 Cleaning and maintenance 43 Product recalls 44 Returned goods

2 A p p e n d i x 1 Templates of letters for use if found not of Standard Quality [Frozen and expired goods ]

Frozen Drugs-ordered to return to the Suppliers-reg(New drug policy 2009)

Frozen Drugs-ordered to return to the Suppliers- for issue of gate pass after verification reg(New drug policy 2009) Stop instruction-reg(New drug policy

2009) Appendix II Material handling in drug stores

31

3 PROCUREMENT ndash Government Order Relating to

the Management of Stores

(Reproduced for reference material on basic

procedure in decentralized system followed by

Health facilities in 1977)

54

F L O W C H A R T S f o r a BI R D S E Y E V I E W o f

P R O C U R E M E N T

5 5

ACQUISITION OF STORES 6 1

PLACING OF ORDERS 6 2

RECEIPT OF STORES 6 2

CUSTODY 6 3

ISSUE OF STORES Maintenance of Stock Books

6 3

PROCEDURE OF INDENTING FOR WARD amp OTHER SECTIONS OF THE INSTITUTION

6 4

HOW OFTEN TO INDENT 6 5

EMERGENT INDENT 6 5

HOW TO INDENT 6 5

KEEPING OF RECORDS IN WARDS A N D S E C T I O N S

6 6

ACCOUNTABILITY OF DRUGS BROUGHT BY THE PATIENT OR RECEIVED IN DON A T I O N BY T H E WARDSECTION _IN - CHARGE

6 7

RESPONSIBILITY OF STORES AT VARIOUS LEVELS

6 7

DISTRIBUTION OF MEDICINES FROM OUTDOOR DEPARTMENT

6 7

LOSS BREAKAGE DAMAGE ETC 6 8

PROCEDURE FOR WRITING OFF STORES 6 9

DISPOSAL OF WRITTEN OFF ARTICLES 7 1

FORMATS TO BE USED 7 3 - 81

32

STORAGE AND STOCK MANAGEMENT The expiry periods of pharmaceutical products have meaning only if the products are stored under proper conditions otherwise products are likely to lose their potency before the actual date of expiry

A pharmacist is a vital link in the distribution chain for pharmaceutical products The medicinal products remain for a long period during the distribution cycle at the wholesaler and at retail pharmacies It is therefore very important to maintain proper storage conditions in these units

Every community pharmacy however large or s mall needs to store and manage its medicine stocks effectively There must be systems to ensure

middot bullbull Secure storage middot bullbull Clean and correct environmental conditions during storage middot bullbull Accurate and effective record keeping middot bullbull Effective stock rotation and expiry monitoring middot bullbull Effective fire and theft prevention middot bullbull Effective rodent pest control

For easier un derstanding this module has been divided into the following sections

1 Quarantine and checking of stocks 11 Quarantine area 12 Checks to be carried out on new stocks

2 S t o r a g e 21 Need for proper storage 22 Different patterns of storage 23 Different means of storage 24 Temperatureclimatic conditions 25 Special storage of supplies 26 Storage and stability of medicines

3 Stock Control and Expiry Monitoring 31 Stock control 3 2 S t o c k r o t a t i o n a n d e x p i r y m o n i t o r i n g

4 Other aspects of s t o r a g e 41 Design of a storage area 42 Cleaning and maintenance 43 Product recalls 44 Returned goods

33

1 QUARANTINE AND CHECKING OF STOCKS

11 Quarantine Area D r u g S t o r e pharmacies receive stoc k s f r o m su pplie r s a c c or d ing to pur c h a se o r d e r s T he stock that is received must be visually checked for quality and quantity The stocks must be kept in a separate area until the checking is done to avoid intermixing with existing stock This necessitates the presence of a separate area within the pharmacy w h e r e i n t h e storage and other checking of stocks can be performed This area is called the QUARANTINE AREA This area should be marked and identified adequately to distinguish it from other areas

The area may be marked using different means 1 ) A s m a l l board saying Quarantine on a separate table used exclusively if it is in the middle 2) A board on the wall if the table on which the quarantine stock is placed is against the wall

middot Stock received from wholesalers should be immediately transferred t o t h e Quarantine Area

middot In the Quarantine area the stock may be stored on racks shelves or in cupboards to prevent ingress of moisture dirt and other contaminants

middot Regular stocks from the pharmacy should not be left kept in the quarantine area Special care has to be taken in case of refrigerated medicines supplied by the suppliers so tha t the y do not remain in the quarantine area for long periods of time They should be immediately checked on receipt and transferred to areas for refrigerated storage s o a s to maintain the cold chain bull

Advantages of having a separate Quarantine Area middot Avoids cross mixing of newly arrived stock from existing stock till it is checked middot Lays stress on checking the quality of the stock received middot S to ck checking ensures t hat defective andor expired goods do not enter the storage areas

34

bullbull

bullbull

12 Checks to be carried out on new stock

Unpacking and checking stock

Supplies received should be unpacked and checked in the quarantine area Staff doing the checks should be adequatel y trained in what they have to check when stock arrives

Checking should be seen not simply as counting the units received but as a part of the quality assurance system bullThis should include middot Visually inspecting the packaging middot Checking the integrity of containers middot V erifying the completeness and leg ibility of la b e ls ( a ppr o ve d dr u g name strength any special storage instructions and expiry date)

bull

The expiry dat e should be checked to ensure that there is adequate shelf life remaining

Supplies should be individually checked using a checklist 35

Checklists

36

The wholesaler supplying the product should be notified immediately in case of any discrepancies ( and the details should be recorded in a register) and sent in a written format to the supplier It should include middot Missing boxes or cartons middot O p en tampered boxes or cartons middot Missing supplies middot Differences in the actual quantity and the quantity shown on the packing middot Additional medicines that had not been ordered but have been supplied middot D a m a g e d b r o k e n o r p oor quality medicines middot Any other discrepancies

The purchase invoices are an important aspect to be considered The invoiced documents should be signed and filed for reference as per the Drugs and Cosmetics Act and retained for at least 3years

If the wholesaler supplies medicines as an emergency without a bill or against a delivery challan

middot The supplies should be checked for integrity and inspected for damage middot The details of supplies received should be recorded middot The supplier should be asked t o send the bill as early as possible middot When the bill is received it should be checked against the details recorded and anomalies if any should be reported to the supplier

To keep a track of the received stock maintaining a S t o c k R e c o r d C a r d c a n b e very useful The entries in the stock record card can be made while checking the stock received STOCK BIN in the stores should have Stock record card

Maintaining a stock card for every product may not be very practical for a retail pharmacy however it could be maintained for costly medicines Nowadays it is much more practical and easier to maintain records using computers

The pharmacist should ensure that medicines manufacturedmarketed by a company are received only through an authorized distribution network of that company This is important to prevent spurious and counterfeit drugs from entering the pharmacy

37

2 STORAGE 21 The need for proper storage The storage of medicines and other products is an important requirement of Good Pharmacy Pr actice Appropriate storage of medicines is essential -

middot bullTo ensure that the potency is maintained middot bullTo prevent deteriorationspoilagedegradation middot bullTo ensuremaintain physical integrity

To ascertain that the quality and safety is maintained throughout their shelf life Storage requirements need to be considered on 2 aspects

a) Integrity of medicines Medicines should be stored in such a way so as to maintain their integrity and potency middot Maintain the right temperature required middot Protect from excessive humidity middot Keep medicines away from direct sunlight middot Protect from pests and rodents

b) Physical location middot Should be easy to locate middot Accessible middot Orderlysystematically placed

2 2 D i f f e r e n t p a t t e r n s o f s t o r a g e The pharmacist could follow any of the different patterns of storage The pattern of stora ge should be selected in such a way that it facilitates speedy and efficient dispensing of medicines

The pattern of storage could vary with each pharmacy experience usual practiceroutine of staff and the person-in charge and also depending on space av ailable turnover etc (i) The medicines could be stored c o m p a n y w i s e ie the medicines manufactured by one company should be grouped together and kept in one place Within each company shelfshelves the medicines may be placed in alphabetical order for easy and quick placement and removal Also bottles tubes boxes etc may be segregated within that shelf

38

(ii) The medicines may also be stored in a lphabe t ic al o r de r ie they are placed in order from left to right based on their name The first letter of the name is used to g r o u p t h e m e d i c i n e s t o g e t h e r a n d k e e p t h e m i n o n e l o c a t i o n I n s o m e p h a r m a c i e s a l l t h e strip packing are placed in drawers or boxes in alphabetical order each box or drawer containing strips of one particular alphabet This system ensures that the strips always remain e n c l o s e d i n t h e b o x e s d r a w e r s a n d a r e n o t e x p o s e d t o d u s t T h e d i s a d v a n t a g e i s that it might lead to mix -u p o f strips in the same drawer and it may cause a problem incase of similar looking strips in which case a wrong medicine may be dispensed Secondly cut strips lying around in the drawer may lose their identity if the batch n u m b e r andor expiry date is not seen on the cut portion of the strip

39

(iii) The medicines may be stored according to their therapeutic class ( e g a n t i b i o t i c s anti asthmatics or anti hypertensives) ie the medicines are kept together based on their pharmacological or therapeutic action

(iv) The medicines may be stockedsegregated according to dosage forms eg l i q u i d s (bottles) solid oral dosage forms eye drops rotacaps ointments etc all stored on separate shelves

Always Remember I Storage of prescription medicines should preferably be separate from OTC medicines OTC medicines especially those that a r e a d v e r t i s e d m a y b e d i s p l a y e d f o r c l i e n t s t o select or to ask questions about [OTC-O v e r t h e c o u n t e r ] II Storage according to temperatures is a must no matter which pattern of storage is followed Also within a particular storage area segregated storage may be maintained In a refrigerator for example medicines may be stored in trays racks and the freezer according to the temperature required

40

Whatever pattern of storage is selected all the personnel should ensure that middot The stocks are stored in an orderly manner middot The medicines are kept back in the same place from where they were removed middot All medicines are arranged neatly once in a while

middot The personnel should be careful while storing the medicines middot They should not throw the medicines haphazardly 23 Different means of storage

middot Within each temperature and security zone medicines must be stored so that they are easily accessible and protected against damage

middot Basic means of storage include shelves racks and drawers middot To prevent dust from entering the shelvesracks it is ideal to have glass

shutterssliding glass doors This can however be disadvantageous because accessibilityspeed is hampered in removing a product from the shelf because the glassshuttersliding glass has to be

41

opened m o v e d e v e r y t i m e a p r o d u c t h a s t o b e p i c k e d u p U s e o f a i r c o n d i t i o n e r s f o r t h e p h arm acy with a closed door at the e n t r a n c e o r a n a i r c u r t a i n c a n r e d u c e t h e d u s t problem In such cases the shelvesracks may be left o p e n

bull

middot Direct storage of cartons on the floor should be avoided because besides being an unhealthy practice the contents may also be damaged by moisture bull

middot Store medicines preferably in shelves with glass shutters for visibility middot Closed shelves further prevent dust from going in especially in India where most

pharmacies are located along busy roads middot Some medicines have to be refrigerated or stored in a cool or cold place Having a

refrigerator or two (as per the need of the pharmacy) is essential to store suc h medicines at temperatures mentioned on the label bull

42

Refrigeration middot All cold chain equipment should meet required standards middot Improvement in refrigeration technology has provided frost -free refrigerators

Pharmacists should opt for frost-free refrigerators as they are easy to maintain and protect printed packaging materials Conventional refrigerators may cause water falling from trays below the freezer on medicines stored in the refrigerator thus causing soggy labels

middot bull Frost-free refrigerators also provide separate and large compartments for the freezer portion (required for storing medicines needing sub-z e r o t e m p e r a t u r e ) and the main storage area with separate doors so that opening one door does not disturb the storage temperature in the other compartment

Care should be taken to keep the refrigerator on 24 hours a day It should not be switched off after working hours It is advisable to have an inverter connected to the refrigerator so that the refrigerator re mains working even when there is a power outage

middot The refrigerator door should be closed tightly middot The refrigerator door should not be left open for too long middot Space should be left between medicines stored in a refrigerator to allow air to

circulate middot The ref rigerator should be placed about an arms length away from the wall

This will increase air circulation thus not affecting the cooling within the refrigerator

middot Vaccines should not be stored on refrigerator door shelves as they are exposed to warmer temperatures each time the door is opened Vaccines should always be stored on the middle shelves of the refrigerator

middot Refrigerated medicines should not be left out of the refrigerator for more than a few minutes

43

middot Consumable products like juices energy drinks e t c s h o u l d n o t b e s t o r e d a l o n g with medicines in refrigerators If required they may be kept in a separate refrigerator

middot An adequate number of refrigerators should be planned to store the entire stocks requiring refrigerated storage

middot Adequate procedures should be followed for defrosting cleaning and maintenance of refrigerators

middot Icefreeze packs should be kept in the freezer compartment so that they can be used for transporting cold temperature medicines The packs can be given to clients along with the medicines requiring cold temperature storage so that the temperature is maintained till the client reaches home and can then put the medicines in a refrigerator) Freezer packs can also be used to keep medicines temporarily in case there is a power outage or refrigerator breakdown

Activity

Prepare a SOP (Standard operating procedure chart) for cleaning a refrigerator Discuss it with your staff finalize its maintenance once a month through AMC -A n n u a l Maintenance contract CMC - Comprehensive maintenance contract and put it up on the pharmacy refrigerator Put the Purchase Order details name of manufacturer Phone of Service Engineer and a register to login the Machine service and down timeService reports may be maintained properly

Refrigerator monitoring and maintenance

middot bullIt is important to carry out routine monitoring and maintenance of the refrigerators and to organize an effective repair system

middot bullThe temperature in the refrigerator must be monitored and recorded routinely at least once a day

middot Any breakdown must be reco rded including the period during which the medicines were exposed to uncontrolled temperatures Medicines may then be kept or discarded depending on the problem guidelines or the manufacturers advice

middot Cold chain monitor cards and devices in or on packages that change color or otherwise alert staff to potential damage assist in monitoring (These are likely to be introduced in India soon)

middot It is essential to have a contingency plan in place before a refrigerator breaks down An arrangement can be made to move the contents to a private refrigerator elsewhere in the community or to obtain a regular supply of ice packs until the defect is rectified

Put filled water bottles in the bottom half of the refrigerator door in order to provide cooling in the refri g e r a t o r w h e n t h e r e i s a p o w e r o u t a g e T h i s m i g h t t a k e c a r e o f t h e temperature when there is no current for a couple of hours If the power outage is expected to last for several hours special arrangements such as an inverter UPS have to be made to keep the refrigerator constantly running in the absence of electricity middot Defrost the refrigerator in case of excessive ice formation and preferably at regular

intervals Keep a record of the same

44

2 4 T e m p e r a t u r e c l i m a t i c c o n d i t i o n s

i) Temperature control middot The medicines in a pharmacy need to be stored at appropriate temperatures to

maintain their stability middot An air-conditioned environment where temperature can be controlled is

recommended for pharmacies Air conditioning offers the option of setting the t e m p e rature as per requirements

middot bullIt is ideal to have an air conditioner to maintain the temperature below 25 C as most medicines require storage below this temperature Secondly this temperature is pleasing to both the staff and the visiting customers too

middot In the absence of an air conditioner circulating fans may be used middot This need is felt even more in certain parts of India where temperatures soar above 45

C and some areas where it falls to sub zero temperatures In such cases temperature maintenance is essential to prevent deterioration of medicines due to unnecessary exposure to drastic temperature fluctuations

middot This need is felt even more in certain parts of India where temperatures soar above 45 C and some areas where it falls to sub zero temperat u r e s I n s u c h c a s e s temperature maintenance is essential to prevent deterioration of medicines due to unnecessary exposure to drastic temperature fluctuations

i i ) Humidity or moisture control Moisture or humidity can adversely affect the stability of me dicines such as tablets capsules powders

45

Gelatin capsules become soft and swell on absorption of moisture The drug content of tablets may undergo surface hydrolysis The presence of moisture may encourage the growth of microbes It is therefore essential to control humidity

To reduce the effect of humidity the following suggestions may be followed -middot Open the windows to allow air circulation Use a fan to circulate fresh (outside) air middot In humid climate a dehumidifier is useful for preventing mo i s t u r e d a m a g e ( i n t h e absence of an air conditioner) middot For bulk containers of tabletscapsules do not keep the container open for a long time and replace the lid or closure immediately after taking out the required number of medicines for dispensing middot Do not allow the medicines to touch the floor or the walls The walls may be damp and may cause moisture absorption damaging the product

middot Calibrated thermometers and manometers can be used to detect temperature and humidity in the pharmacy

middot Periodici t y of checking the temperature should be fixed middot The climatic conditions should be recorded and documented middot Temperature charts should be available for ready reference

Documentation is one of the core activities for achieving and maintaining quality It is one of the most essential components of validation Temperatures in various areas

46

including refrigerators should be recorded at a predetermined periodicity usually daily at the hottest time of the day and such documents should be preserved i i i ) Storage conditions A number of storage conditions are mentioned on the labels of medicinal products These conditions have to be properly interpreted and appropriately complied with

According to the Drugs and Cosmetics Rules 1945

1 The term cool place means a place having a temperature between 10 C and 25 C

2 The term cold place means a place having a temperature not exceeding 8 C In case of storage conditions for specific products please refer to Schedule P The Drugs and Cosmetic Rules 1 9 4 5

The Indian Pharmacopoeia specifies the following storage conditions -

Wherever the condition for storage is not specified medicines may be stored under normal temperature In a country like India however where normal temperatures soar to h i gh temperatures it is recommended that medicines be stored in a cool place

Activity Prepare a list of the storage requirements mentioned on the label of about 20 products in your pharmacy and check if the temperature is maintained

47

25 Special Storage o f s u p p l i e s If the product has no special instructions normal storage conditions apply This means storage in dry clean w e l l -ventilated premises at temperatures of +15 C to +25 C or depending on the climate up to +30 C (WHO1990) Storage instructions are product specific Different brands of the same generic drug may have different storage requirements as they may have different packaging or formulations It is essential to follow the product manufacturers storage instructions to the maximum extent possible Less stable medicines must be stored in specific conditions to maintain their quality or potency

The following products require special storage facilities

middot Products that must be kept frozen (usually vaccines and sera) middot Products sensitive to h eat an d r e q uir in g r e f r ig e r a tio n ( +2 C to +8 C) middot Products that have reduced shelf life at uncontrolled room temperature and need

mechanical ventilation or air conditioning middot Flammable products that require separate fireproof premises middot Products prone to theft o r m i s u s e

Products needing storage in a controlled environment -

The usable shelf life of the following products may be reduced if stored at uncontrolled humidity or at room temperature in hot climates -

middot Some injectables (eg adrenaline) Most injectable preparations are less stable than solid oral forms (tablets and capsules) Injectable preparations in solution are particularly unstable Many injections must be protected from light as well as heat

middot Intravenous fluids (particularly if packed in p lastic containers) middot Some suppositories pessaries creams and ointments These products may melt at

temperatures greater than 30 C Once this happens it is not advisable to use them because the active ingredient in the formula may get unevenly distributed

middot Products containing rubber latex cellulose or some plastics Condoms most sterile disposable medical devices and surgical products such as syringes needles and catheters require protection from excessive humidity and strong light and heat Any o f these conditions may make products brittle stained amp unusable Sterility cannot be assumed if packaging is damaged

In hot climates these products should be stored in the coolest place possible preferably with air conditioning or air circulation fans

48

Products needing freezing or refrigeration-middot Vaccines blood products and many other medicines lose potency if kept even for a

brief period at temperatures outside the recommended range For these products the cold chain must be maintained at every stage of the distribution system

middot Freezing is as damaging as high temperatures for some products including injectable contraceptives ergometrine insulin adrenaline and the DPT DT TT and Hepatitis B vaccines Such products therefore sho uld not be allowed to freeze (not be kept in the freezer compartment)

middot Short periods at room temperature (during transportation or local distribution for instance) may be acceptable for many products (such as ergometrine a n d i n s u l i n ) e v e n t h o u g h s u c h e x posure can to some extent reduce shelf life Other items such as vaccines should always be transported in cold boxes

Storage of insulin injections-

middot Insulin should always be stored in a refrigerator at the recommended temperature of 2 -8 C

middot Insulin should not be kept in the freezer compartment of the refrigerator middot Insulin should ideally be stored horizontally middot It should not be exposed to sunlight or excessive heat middot Insulin suspensions should not be used if the suspension cannot be properly

resuspended due to cake or clump formationbull

Controlled drugs -Narcotics (for example Pethidine injection morphine preparations) and other specified drugs that may be abused are governed by special legislation and regulations The following security measures are suggested in the pharmacy -middot A safe or reinforced double locked cabinet fitted with a light (preferably with a red

bulb) that comes on when the door is opened

49

middot A special register recording details of each receipt or issue with 2 signatures physi cal counting of medicines after each entry and signatures at handover takeover

middot Independent audit (by supervisors and drug inspectors)

Products prone to theft abuse or misuse -

Some medicinesproducts are particularly prone to theft abuse or misuse These include expensive medicines (eg insulin) certain antibiotics and products prone to abuse or misuse like psychotropics etc

Such medicinesproducts should be stored adequately They require stricter record keeping and more frequent stock taki ng than others Periodic audits should be carried out to check for consumption against actual recorded use (registers prescription records stock records etc) to expose any theft or misuse bull26 Storage and stability of medicines Medicines are not stab le indefinitely They are stable for a specific period of time sometimes for a brief period Poor storage conditions accelerate the drug degradation (decomposition) Temperature light and moisture are the most important contributing factors for drug instability It is important to identify and be aware of the potential for instability There is a need to comply with storage requirements to ensure quality medicines for patients It is also important to offer advice to patients too about appropriate storage o f medicines at home The dispensing label should state the storage condition required and be backed up by a verbal reminder especially where special storage is required bull

50

In case stability and storage problems are seen with formulations they should be reported immediately to the representative of the manufacturer and taken out of circulation till the stability problems have been resolved

The pharmacist can easily detect stability problems when products show change in appearance color odor settling of the product contents breaking of emulsions melting of creams oozing of contents from the containers and any such physical changes

3 STOCK CONTROL AND EXPIRY MONITORING 3 1 S t o c k C o n t r o l For economic reasons pharmacists do not like to have stock on their shelves for long periods of time The aim should always be to keep stock at a level that will just meet demand Normally most manufactured medicines have a long shelf life Even then it is essential that there is efficient stock rot ation so that the older stock is used first It is also a good practice to check the expiry date as an integral part of the dispensing process When short shelf life products are involved stock levels may have to be modified to prevent medicines regularl y expiring on the shelves

32 Stock rotation and expiry monitoring In order to avoid accumulation of expired and obsolete stock medicines should be stored and issued according to the following guidelines -middot The stock control system must record the ex p i r y d a t e a n d t h e d a t e o f r e c e i p t middot Stock must be stored so that earliest expiring batches are picked and issued first middot The First In First Out (FIFO) system - In this system the stock which is received

first is sold first This system however may not be useful for pharmacies because most of the stocks carry an expiry date For pharmacies the FEFO system is more practical

51

middot The First Expiry First Out (FEFO) system - In this system the stock having an earlier expiry is sold first The stock with longer shelf life should be placed farthest to the back (or at the bottom in case o f sta c k e d b oxe s) T h is is pa r tic u la r ly impor ta n t with products that have short shelf lives such as vaccines some vitamins antibiotics etc and reduces losses due to expiry

middot E x p i r y dates should be noted on the stock record upon receipt Stock nearing expiry should not be accepted unless it can be used before expiry

Computerization and expiry monitoring In the pharmacy computerization facilitates both checking stocks and expiry mo nitoring and helps-bullbullKeeping a check on products nearing expiry bullbullKeeping a check on non- moving and slow moving products bullbullTo facilitate the removal of medicines nearing expiry from shelves in time to send them back to the wholesaler or supplier

Periodic checking for expiry The expiry date for medicinal products is a critical aspect in pharmaceutical dispensing and due importance should be given to it Periodic checking for expiry of medicines will ensure that the patient will never receive products that have crossed their expiry date During periodical checking of expiry the personnel involved should remove medicines that are nearing expiry bullbullIn -house threshold periods should be set and followed for retrieval of such medicines from the shelves bullbullSuch medicines should be stored separately These should either be dispensed immediately (thus ensuring that they are used before the expiry date) o r t h e y s h o u l d b e returned to the suppliers bullbullA separate area should be designated (cupboard or shelf)marked[FROZEN ZONE] which is adequately marked EXPIRED GOODS- NOT FOR SALE to store all expired stocks FROZEN ZONE

52

Remember Expired medicines are a NATIONAL WASTE So stock only what you can sell Avoid expiries save precious medicines for the nation

Treatment and disposing of expired medicines bullbullProcedures need to be in place for the treatment of expired medicines bullbullThe expired medicines need to be collected and be sent back to the supplier or company for appropriate disposal bullbullRecords must be maintained for expired medicines and how they are disposed off bullbullIn case of medicines that are not returnable to suppliers procedures for disposal need to be followed by the pharmacy in conjunction with the FDA The following procedure can be followed if medicines cannot be returned to suppliers ( T h e b a s i c p h i l o s o p h y of appropriate disposal is to prevent their re- circulation and use) bullbullC u t t h e c o n t ainer in such a manner that the label is also cut In case of tablets and c a p s u l e s d e s t r o y them by disposing them in a bucket of water bullbullUse landfill procedures (deep burial into the ground as per stipulations of Medical Waste Disposal Act prevalent in the respective state) bullbullPour the liquids into the sink and wash away with sufficient quantity of water bullbullKeep a record of such disposal with full details of medicines destroyed Although these measures are usually adopted care has to be taken with such tr e a t m e n t a s studies have shown that flushing of medicines has resulted in tracessmall quantities of medicines being found in waterways and groundwater having potential health and environmental effects

4 O T H E R A S P E C T S 41 Design of storage areas The following important factors need to be considered in design of storage areas -middot The retail outlets in hot areas in summers should be air-conditioned Similarly in

a r e a s o f e x t r e m e c o l d t h e p r e m i s e s w o u l d r e q u i r e w a r m i n g e s p e c i a l l y i n w i n t e r s t o maintain cool temperatures The placement of air -conditioners and heating devices should be such that medicines are not directly exposed to the cold or heat

middot Due consideration should be given to storage requirements of formulations while designing shelves and cupboards in retail outlets Sufficient shelf height should be provided so that all liquid products can be stored vertically As far as possible the shelves should be covered with glass panels to protect medicines from dust and p r e v e n t r a p i d f l u c t u a t i o n s i n temperature

middot Medicines should be stored according to the storage instructions on the labels bullIt is ideal to have a door at the pharmacy entrance to prevent dust from coming in as well as reduceprevent cooled air from going out This may not however be considered feasiblepracticable by many pharmacy owners for fear that clients may not enter the pharmacy because the door may act as a barrier An air curtain is a good alternative to a door

middot There should be minimal direct sunlight falling on the products Particular consideration should be given to premises directly facing the sun

middot bullThe arrangement of lighting in the interior of the premises should also be in a manner that the lights are not focused on the products It has been shown that light causes not only chemical damage but also can catalyze physical changes like moisture uptak e by the products Care should be taken to ensure that only diffused light falls on them

53

middot As far as possible provision should be made for a temperature and humidity indicator device in a pharmacy These devices are now easily available

middot Stability studies o f m e d i c i n e s p a c k e d i n b l i s t e r s h a v e r e v e a l e d t h a t i f t h e s e a r e exposed to light they tend to absorb moisture It is therefore necessary to store them in suitable cartons so that the blisters are not exposed to light Pharmacists should do this even if the manufacturer has not provided cartons

middot Light and temperature sensitive products should not be stored on counters where the light is intense or direct and there is no protection from temperature and humidity

42 Cleaning and maintenance i) Cleaning of storage areas

The storage areas of the pharmacy should be cleaned periodically and cleanliness should be maintained at all times The Standard Operating Procedure for cleaning should be designed and followed accordingly Schedules for cleanups should be laid down and adequate cleaning equipment should be made available

Tips for maintaining cleanliness middot Provide clean pieces of cloth for wiping at various locations in the pharmacy

Replace with clean cloth at regular intervals middot Keep separate pieces of cloth for floors shelves and medicines middot Use a disinfectant andor soap solution to clean floors middot Ensure removal of dust and prevent accumulation of dirt middot Ensure removal of cobwebs middot Use a vacuum cleaner for cleaning areas not easily reachable middot T a k e c a r e t h at breakages are handled and cleared effectively middot Observe the factors leading to waste generation in the pharmacy and take appropriate

measures to tackle the problem middot Record all cleaning procedures performed and maintain all the documents required

For ex a m p l e -bullbullThe floor of the pharmacy may be swept with a broom and swabbed with soap water every morning bullbullThe floor may be swabbed with a disinfectant every week bullbullThe entire premises including shelves and cupboards may be cleaned with a cloth (to remove dust and to check for medicines approaching expiry date or expired medicines) every three months bullbullAll the steps followed should be r e c o r d e d

The floor shelves drawers have to be cleaned and a check should be kept on dust cobwebs spillages due to breakage etc It is therefore essential to have SOPs for cleaning laying down cleaning frequencies allotting responsibilities and maintaining a daily record in the logbook to document all these activities

54

While cleaning dust settled on dosage forms like bottles tubes etc should be removed Before dispensing the products should also be wiped to remove any dust settled during storage

For refrigerators bullbullDefrosting and cleaning should be done at regular intervals bullbullSwitch off the refrigerator while cleaning bullbullCleaning should be done quickly and stocks put back immediately

i i ) Pest control Pests are a serious problem in India where insects reptiles and rodents (eg cockroaches l i z a r d s r a t s s i l v e r f i s h (Deemak - in Hindi ) etc) may find access to the pharmacy storage areas Insects like ants and borer ants may often attack wood in the pharmacy causing d am ag e to shelves cupboardsPest c ontr o l in a p h a r m a c y c a n b e a d i f f i c u l t t a s k b u t t o avoid possible contamination and physical damage to stock it is necessary to keep pests out of the pharmacy premisesPest control measures should be implemented with proper p r e c a u t i o n s t a k i n g u t m o s t c a r e t o a v o i d contamination of medicines

55

Th e following pest control measures c a n be ta ke n f r om tim e to tim e -bullbullRat bait and traps can be placed at various locations bullbullInsecticutors can be used on a permanent basis bullbullInsecticidal sprays and repellants can be used from time to time

i i i ) Fire precautions

Combustible trash such as cartons boxes and other packing waste must not be allowed to accumulate in the store Waste should be deposited in appropriate waste bins and be d i s p o s e d o f f o n a d a i l y b a s i s

F i re detection and fire fighting equipment must be maintained and regularly inspected The pharmacy personnel should receive adequate training in fire fighting techniques and emergency actionFire prevention measures should include a prominently displayed ldquoNoSmokingrdquo sign careful handling and disposal of combustible waste materials and checking of electrical connections at regular intervals

iv) Security middot Doors shutters of the pharmacy should be strong and be fitted with secure locks middot Counters should be designed so that unauthorized personnelclients do not have

access to areas where prescription medicines are stored Access to such areas should be restricted to the pharmacy staff

middot All the pharmacy staff handling supplies should be accountable for their ac t i o n s

56

middot bullSpecial care must be taken in case of Schedule X and manufactured drugs (under NDPS Act) Such medicines should be kept under lock and key and the key should be kept with the Chief Pharmacist or i n h i s a b s e n c e t h e s e n i o r p h a r m a c i s t

v) Breakagespillage and damaged product Products that have been damagedspoiled during storage and handling spillages and broken glassware should be disposed off according to procedures laid down by the pharmacy Broken and damaged products s h o u l d b e p l a c e d i n a segregated area to be returned to the supplier

vi) Inspection Senior staff should inspect all pharmacy areas regularly The shelves and drawers should b e c h e c k e d d a i l y f o r signs of pests and dust Ceiling and walls should be checked for dirt and cobwebs Stock should be checked on a regular basis for deterioration due to climatic conditions

43 Product recalls Products found to be defective should be quickly recalled (withdrawn from the market) The instructions are generally issued either by the manufacturer or the regulatory agency The level of recall is determined by both the degree of risk and the extent of distribution of the product and in India is mainly directed at the distribution chain

On receiving the details of the defective substandard spurious batchbatches of a medicine to be recalled from the manufacturer or the stockist or the FDA the pharmacy should immediately check if the particular b a t c h i s i n s t o c k a n d i f s o s u s p e n d i t s s a l e immediately

Similarly if the regulatory authority in the country bans a particular medicine or FDC the pharmacy should immediately check and remove all the different brands of that particular medicine under consideration

The details of medicines and their batches to be recalled should be available in the q u a r a n t i n e a r e a w h e r e stocks are received and checked This is to ensure that such medicines do not come into the pharmacy

middot The pharmacy should develop SOPs for recall of medicines middot The pharmacy staff should be immediately informed about such medicines and

the details should be displayed in writing in a prominent place in the pharmacy middot Rapid action helps avoid unnecessary exposure to such medicines once the

problem has been d e t e c t e d middot The progress of the recall procedure in the pharmacy should be monitored every

few days to ensure complete compliance middot All stocks of the recalled products should be stored separately from the saleable

stock These can be stored in the expiry cupboard segregated from the expired goods and be appropriately labeled ldquoRecal l e d G o o d s - Not for Salerdquo

The supplier should be notified and asked to replace defective products middot All the details of the procedures followed should be duly recorded in a Recall

Register maintained specially for the purpose The register should include d etails such as -middot Date of the recall middot Nam e of the product

57

bullbull

middot Details of the product (name of manufacturer batch number expiry date) middot Nu m b er of units purchased sold a n d sto c k in ha nd middot Reason for recall middot Nam e of the supplier to whom produc ts w e r e returned along with the date and quantity middot Name and signature of the designated personnel carrying out the recall procedure and recording details middot Name and signature of the chief pharmacist verifying the recall procedures and recording details 4 4 Returned medicines

Medicines may be returned to the pharmacy by clients due to the following reasons -bull

bullbull Unused medicines bullbull Course not completed bullbull Therapy changed by doctor bullbull Side effects experienced by patient bull

bullbull DamagedDefective medicines bullbull Missing or defaced label bullbull Missing tablets in a stripblister bullbull Leakage in bottles bullbull Leakage in strips bull

bullbull Expired medicines

Appropriate SOPs should be framed and followed for their acceptancerefusal and disposal middot bull For unused medicines returned by clients the p harmacy personnel should verify

that these were purchased from their pharmacy They should then be checked for integrity of the packing the dosage form and the expiry date and verified with the client whether they were stored in appropriate conditions This again is at the discretion of each pharmacy

middot The damageddefective medicines returned to the pharmacy should be taken back and stored separately Existing stock of the same product should be checked for similar defects

middot Expired medicines should be accepted from clients at the discretion of the pharmacist and be immediately shifted to the expired goods cupboard These can be stored segregated from the pharmacys own expired goods and be appropriately labelled ldquoExpired Goods returned by clients- Not For Salerdquo

It is advisable not to accept returned medicines requiring cold chain storage (refrigeration) because it cannot be ensured that the cold chain was maintained when the medicines were in the hands of the patientclient middot Appropriate adjustments in t he stocks should be made for medicines

returnedexchanged to update the inventory middot The medicines should then be returned to the respective shelves middot A lsquoReturned Goodsrsquo register needs to be maintained to record all details of returned

medicines

R egister should include such details as-

58

middot N a m e o f t h e p a t i e n t middot Nam e of the product and quantity r e tu r n e d middot Product details such as the batch number and expiry date middot Condition in which received middot Reason for returning products middot Compensatory measures taken wi t h r e s p e c t t o c l i e n t middot Action taken with respect to product middot Name and signature of the personnel accepting the returned medicines and recording details middot Name and signature of the chief pharmacist verifying the recorded details

What the pharmacist would have learnt from this module The storage of medicines is a critical factor in the distribution cycle bullbull Stocks received by the pharmacy should be quarantined in a separate area and necessary checks s h o u ld be performed to ascertain the qua lity a nd quantity of stocks received bullbull Whatever pattern and means of storage used the products should be stored so as to maintain their potency and integrity bullbull Storage conditions should be monitored and maintained on a regular basis bullbull Optimum stock levels should be maintained and regularly monitored for expiry bullbull The design of storage areas should facilitate appropriate storage of medicines bullbull Cleanliness should be maintained in the pharmacy bullbull Adequate measures should be taken in case of returned medicines and recalled products

Optimum storage of medicines is mandatory whether at the distribution stage at the pharmacy or ultimately within the homes of patients The pharmacist has an important r o l e t o p l a y i n t h e s t o r a g e o f m e d i c i n e s i n m a i n t a i n i n g d r u g p o t ency and efficacy and thus facilitating optimum therapeutic benefits Good Pharmacy Practice - IPA -CDSCO - WHO Appendix I Quality Assurance Templates of letters for use if found not of Standard Quality [Frozen and expired goods ]

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated To Name of the Supplier with address

Sub Not of Standard Quality GoMP-Supply of Drugs and medicines-(Codename) Return of Stocks to the Suppliers-reg(New drug policy 2009) Previous letterinvoice ref Sl No Drug Code Drug name

Manufacturing date Expiry date

Supplier address

B a t c h n o

The above items of PO nodated was drawn by the Drug Inspector (Place) on (______________date) as a statutory sampling and declared ldquoNot of Standard

59

Qualityrdquo on -(______________date) by the Government Analyst for the following reasons

- ldquoThe product sample do not confirm to IP specification for (Drug codename with respect to the content of drugrdquo

- ldquoThe product has already been blacklisted by TNMSC on -(______________date) for the failure of (quantity) of batches of drug codenamerdquo

As per the clause of the te nde r d oc um e nt ldquo I f the sa mple s d o not c onf o r m to statutory standardsthe tenderer will be liable for relevant action under the existing laws and the entire stock in such batch should be taken back by the tenderer within a period of 30 days o f t h e r e c e i p t o f t h e l e t t e r f r o m t h e v e n u e

The stock shall be taken back at the expenses of the tendererthe Procurement Authority have the right to destroy such Not of Standard Quality if the tenderer does not take back the goods within the stipulated time

The Procuring Authority will arrange to destroy the Not of Standard Quality drugs within 90 days after the expiry of 30 days mentioned above without further notice and shall also collect demurrage charges calculated at the rate of 2 per week on the value of the drugs rejected till such destructionrdquo

Hence we regret to inform you that you will have to take back the stocks available of the abovesaid batch at your own cost from the drug stores where you have supplied the above batch

Kindly acknowledge the receipt of this reference at once

P r o c u r e m e n t A u t h o r i t y Seal and Stamp

Copy to Ref No dated

1 ) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated13082010

To

Sub Frozen Drugs-ordered to return to the Suppliers-reg(New drug policy 2009) Previous letterinvoice ref

The following products which were earlier frozen have now been ordered to return to suppliers directly with permission from the State drug Authority In this regard the suppliers have been instructed to take back their failed batch from the drug store of the stores Hence you are now instructed to return the following failed batches to the suppliers by obtaining proper authorization letter and acknowledgements from them

60

Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

Kindly acknowledge the receipt of this reference at once

Procurement Authority Seal and Stamp

Copy to

Ref No dated 2) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated14092010

To

Sub Frozen Drugs-ordered to return to the Suppliers- for issue of gate pass after verification reg(New drug policy 2009) Previous letterinvoice ref

The following products which were earlier frozen have now been released Hence they may be issued Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

Kindly acknowledge the receipt of this reference at once

Procurement Authority Seal and Stamp

Copy to

61

Ref No dated 3) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated

To

Sub Stop instruction-reg(New drug policy 2009) Previous letterinvoice ref

Until further instructions stop issue all the batches of the following item Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

You must intimate the available stock in the stores of the said batch Number to the Procurement Authority immediately Also retrieve quantity if already issued

Procurement Authority Seal and Stamp

Copy to

Ref No dated 4) HOD Procurement Office of

62

Appendix II Material handling in drug stores

Rack approx rates and dimensions

S No

Item Description UOM Approx Rate

1 MEDIUM DUTY RACK SIZE 2900 H X 3090 W X 800 D IN MM (AS PER SPECIFICATION)

Each 2499800

2 MEDIUM DUTY RACK ADD ON UNIT FOR SIZE OF SR NO2

Each 2243100

To locate a Box no 3 Rack no 14 in row3

SAMPLE OF RACK no Bin numbering -------------- S a y R K 1 4 R o w 3 B o x 1 6

SAMPLE LAYOUT of RACKS in a Drug Stores

63

Sample of another warehouse of distribution warehouse system

64

65

Slotted Angle racks with bin cards

66

Plastic Pallets

Plastic pallets ar e l i g h t w e i g h t l o w- c ost and exceed industry standards for strength and durability

NOTE A pallet has bottom deckboards (see sketch) A skid does not have bottom

67

deckboards

Battery Operated Stacker

Electric Stacker Ehh (Manual Push Type) - Manual drive - Lifting electrically with Battery 12 V 88 Ah - For loading and un-loading of trucks - Battery and loading device built - in - Battery charge gauge and charging current gauge Simple and Easy Operation - Lifting and Lowering electrically direct on steering arm - Pulling and pushing through steering arm - Electrically operated relief valve on hydraulic aggregate Safe Operation - Emergency Off Switch - Constant lowering speed - Protection through lowering brake valve - Overload protection through overload brake valve - Load chains covered preventing pinching threat - Electrically interlocking during loading process - Secured battery compartment opens upwardly - Stable buffering of the steering arm in upright position - In accordance with EWG Guidelines 89 240 - In accordance with VBG 12b Prevention of Accidents

Pallet Truck [ Top ]

68

----------------------------------------------------------------------------------------------------------------------------

For Transport Of All Goods On Pallets Safe and Easy Operation - through single hand operation Lifting moving

lowering with steering handle - neutral position of the hydraulic possible - overload pressure relief valve Long Service Life - robust co n s t r u c t i o n

- special hardened axles - hardened chromium plated ram - maintenance free Easy Maneuverability - through rubber steering rollers - nylon fork rollers

A h a n d t r o l l e y

69

Trolley with plastic bins for several items del ivery

70

Digital Weighing balances

Balances amp Scales EF Seriers Precision Electronic Balance

71

1

Ice lined Refrigerators

600 litres refrigrator

72

Walk in cooler

vacuum cleaner

73

(b) The Outdoor incharge shall arrange to maintain a stock of common drugs (list of which shall be prepared by the Head of t he Institution) and arrange to replenish the stocks once a week as has been laid down for wards (c) No proprietary drugs shall be issued on the prescription of an intern ( d ) The Head of the institution shall make out a list of drugs which can be issued on

the prescription of a houseman from the Outdoor stock without the countersignature of any other authority

(e) The residents can prescribe any drug from Outdoor stock without the counter signature of any authority

(f) The Consultants can prescribe any drug to any ot h e r o u t e r p a t i e n t e v e n i f i t i s n o t s t o c k e d i n t h e o u t d o o r b u t t h i s s h a l l h a v e t o b e c o u n t e r s i g n e d b y t h e h e a d o f t h e institution for issue from The Main Store

(B) T h e p e r s o n i n c h a r g e o f t h e O u t d o o r m e d i c i n e s s t o c k s h a l l k e e p a r e c o r d o f t h e q u a n t i t y o f t he medicines issued to each patient and instead of writing the name and other details e may only put down the Registration number of the patient and the quantity issued

At the end of the day he must work out the total expenditure of eac item and draw it s balance

The Medical officer in charge of the Stores and the Head of the institution sould check these records at least once a week and affix is signature to confirm their inspection

(C ) No proprietary medicine shall be issued without a valid issue s l i p ( A n n e x u r e- F)

(a) For Housemen the slip would be of brown colour ( b ) For residentsDemonstrators it shall be of pink color (c) For consultants the issue slip should be white ( d ) All issue slips should be printed and pages serially numbered (e) T h e d o c t o r s t o w h o m s u c h i s s u e s l i p s w o u l d b e i s s u e d s h a l l b e h e l d

responsible for their sa f e ke e ping a n d th e y w ould e n su r e tha t th e se slip s would be printed and serially numbered

(f) The doctors prescription slips (for issue from hospitals) of proprietary drugs be prepared in du plicate with the help of carbon One copy should be given to patient for obtaining medicines from the Stores and the other would remain in the Doctors Prescription Slip book

(g) Every issue Slip should be signed and below the signatures a rubber s t a m p s h o w i ng name and designation be affixed The Store people would n o t h o n o u r s l i p u n l e s s t h e n a m e o f p r e s c r i b e r i s c l e a r a n d h i s a t t e s t e d signatures are available to stores

( h ) The Store Staff would file prescription slips of each doctor separately to facilitate the scrutiny at least once a month by the Head of the Institution Such a Scrutiny would reveal over prescribing of or injudicious use of drugs

(C) Proprietary medicines should not be issued for more than three days requirement at a time The only exceptions being cases for cancer pulmonary tuberculosis and leprosy In exceptional cases an officer not below the rank of a Consultant can prescribe for more than 3 days but after the countersignatures of the Head of the Institution

15

XV LOSS BREAKAGE DAMAGE ETC

(A) Any loss of public money departmental revenue of receipts stamps stores or other property held by or on behalf of the Government caused by defalcation or otherwise discovered in an office or institution should immediately be reported by the officer concerned to the head of department through his immediate superior as well as to the Accountant General if the loss exceeds Rs 20000(fig of 1977) (for Proforma see Annexure I)even when such loss has been made good by the party responsible for it Such reports must be submitted as soon as possible and soon after suspicion arises that there has been a loss they must not be delayed while detailed enquiries are made

When the matter has been fully investigated further and complete report should be submitted of the nature and extent of loss showing the errors or neglect rules by which such loss showing the errors or neglect of rules by which such loss was rendered possible and prospects of effecting such recovery

The s ubmission of such a repot does n o t d e b a r t h e l o c a l a u t h o r i t i e s t a k i n g f u r t h e r a c t i o n which may be deemed necessary like handing over the case to the police

Every Government servant should realize fully and clearly that he will be held personally responsible for any loss sustained by the government through fraud and negligence on is part and that will also be held personally responsible for any loss arising from fraud or negligence on the part of any other Government servant to extent to which it may be shown that he has contributed to loss by his own action or negligence

A s s o o n a s s h o r t a g e i n s t o c k o r l o s s i s d i s c o v e r e d a p a r t f r o m r e p o r t i n g t h e m a t t e r a responsible officer should be deputed to investigate the matter

W h e r e t h e r e i s n o l i k e l i h o o d o f a d e l i b e r a t e t h e f t b u t l o s s i s a result of neglect onlythe loss should be made good by the person on whose charge or custody the article lost remained

(B) As soon as damage or breakage of Government property is detected certain steps mentined under should be undertaken-

(a) A p r o m p t t h o ro u g h i n v e s t i g a t i o n i n t o t h e c a u s a t i o n o f b r e a k a g e o r d a m a g e s h o u l d be undertaken by the doctor-i n -charge of the WardSection or by the Head of the Institution

( b ) The investigating officer should draw conclusions as to whether the breakagedamage has been a result of-

(i) C a r e l e s s a n d n e g l i g e n t h a n d l i n g ( i i ) Unpredictable action of the patient for whom the equipment was

being used (iii) Accidental ( i v ) Manufacturing Defect

A report is then prepared in duplicate by person in charge of the article under question on the lsquobreakage and loss proformarsquo (See Annexure H)

16

These reports have to be signed by the investigating officer and are to be then submitted to competent authority for suitable action One copy which is returned is to be kept with the Stock Register In cases where the b r e a k a g e o r d a m a g e i s o f s u c h b i g g e r d e g r e e t h a t s atis factory repairs are not possible a n d if suc h b r e a k a ge o r da m a ge is o f su c h a de gr e e that satisfactory repairs are not possible and if such breakage or damage has been caused-

( i ) B y a G o v t s e r v a n t because of negligent or careless handling cost of the article should be recovered from him and credited to the treasury (ii)On account of reasons mentioned above that is un predictable action of the patient accidental or manufacturing defectthe article could be written offsubject to powers delegated to the concerned for such purpose

(C )Shortages detected during biannual physical verification of the Storeshave to be dealt in a similar manner

(D) it shall be at discretion of the competent authori ty (who is empowered to write off the loss) to reduce the amount of recovery upto 50 of the cost of article provided that before arriving at such a decisionhe has taken into account the following points (a) Normal life span of the article under questi on (b) Period for which it has been in use (c ) Condition of the article at the time of loss or damage and (d) Whether it was on account of careless or negligent act or not

XVI PROCEDURE FOR WRITING OFF STORES

(a) When any Stores become unserviceable otherwise than in ordinary course or by fair wear and tear their value should be treated as loss to the Government and in such cases cost should be recovered from the person responsible for his negligence

( b ) A s t r i c t w a t c h s h o u l d b e k e p t o n t h e m e d i c i n e s w h i ch bear an expiry date and if there is no likelihood of their being utilized locally intimation of the fact should be sent to Directorate of Health services and also to all o t h e r d i s t r i c t s s i m u l t a n e o u s l y s o t h a t t h e y c a n b e p u t t o u s e b e f o r e t h e expiry date In the event such a course is not followed and the Government i s p u t t o l o s s c o s t o f t h e m e d i c i n e i n q u e s t i o n s h a l l b e r e c o v e r e d f r o m t e defaulter

(c) For declaring articles as unserviceable a Committee of three members should be formed in each officeinstitution This Committee should examine each and every article brought before it and should record full reasons for condemning them and also say how the articles condemned have to be disposed of-whether by sale (by public auction) or otherwise

I f t he local Authority is not competent to write off the articles condemned by the Committee it should send the proposal to the higher authority for suitable a c t i o n

17

In Institutions where there is only one doctor a list of articles to be condemned should be p r e p a r e d a n d o r d e r s o n i t b e o b t a i n e d f r o m t h e inspecting authority during inspection

While preparing any list of articles for condemnation details regarding the date of purchase date of receipt period during which it remained in use usual life of the article and its purchase price should be noted against each item

( d ) The condemned articles should not be struck off the Stock Register till the competent authority sanctions its write ndashoff Details of Authority under which the article has been written off should be mentioned in stock register

XVII DISPOSAL OF WRITTEN OFF ARTICLES

Articles like linen should be torn into strips 10cm width so that they could be burnt or given to Government Jails for making carpets

Items like bed -pans bowlsurine po ts etc should be crushed and kept for auction

Brass utensils have also to be crushed to destroy their shape and could be either auctioned or after inviting rates from several dealers could be locally sold to highest bidder

In case when condemned ar ticles have to be sold by public auction they should be stored safely and the Government Auctioneer be intimated In case he expresses his inability to undertake the auction the officer should proceed with the auction departmentally The sale proceeds in either case should be credited to the Treasury as miscellaneous receipts under the Proper head of account

XVIII PHYSICAL VERIFICATION (a) The stocks held by officesinstitutions in various sections should be physically

verified twice a yearin the months o f April and October ( b ) Checking should be done by an officer other than te one who holds the charge of

Stores (c) Verification should be done in presence of officer holding the charge of Stores ( d ) All discrepancies found during the verification should be properly investigated

and accounted for

(j) Any excess detected during verification should be entered in the Stock book as Receipts with the remark ldquo Excess found on verificationrdquo

(ii)any shortage should be noted in issues column of lsquo Issuesrsquo described as lsquoshortage fou n d o n v e r i f i c a t i o n rsquo

XIX ANNUAL STORES ACCOUNT This account should be prepared according to the instruction issued from the department from time to time This should account for the outgoing financial year on the following lines -(a) Cost of the articles under various heads on the last day of the previous

year 18

( b ) Cost of the articles under the various Heads Received during the year (c) Cost of various articles written off during the year under review ( d ) Cost of the articles on the last day of the year or on the firs t d a y o f t h e

financial year following

19

Annexure A WardSection Indent Register No Issued on

Name of institution Page Folio No

Serial no Name of Article Quantity in Stock

Quantity required

Prepared by Approved by Recd by Note-Indenting Officer to sign and affix seal with name and

designation below the last item to avoid additions in one strokeno issues to be made by storesif Issue vouchers of

previous Indent has not been returned back by the WardSection

20

Annexure B Issue Voucher No (printed number)

Supplied to Wardsection Date

Indent no

Serial no Name of Article Quantity in Stock

Quantity required SB No

Stores-in MO Resident in Sign of charge charge WardSection

NurseCompounder Prepared by Recd Approved by by

Note-Indenting Officer to sign and affix seal with name and designation below the last item to avoid additions in one strokeno issues to be made by storesif Issue vouchers of previous Indent has not been

returned back 1st copy-Stores 2nd copy -Wardsection3rd copy-Tobe reurned to sores with Stock book entries

21

Annexure C

STOCK REGISTER FOR DEAD STOCKS

SERIAL NO DATE OF RECEIPT

Article with description

No of pieces Cost Details of

Bill Signature No Disposed

Date of disposal

Manner of Disposal

with Authority

Value realised Signature

1 2 3 4 5 6 7 8 9 10 11 12

P r e p a r e d B y C h e c k e d b y A p p r o v e d b y

Date Designation Name of Institution

22

Annexure D

STOCK REGISTER FOR EXPENDABLE ITEMS Name of article

Date

From where

received with cost

Quantity Signature To whom issued Quantity Balance Signature

1 2 3 4 5 6 7 8

23

Annexure E

Receipt amp Issue Register for WARDSSECTIONS (one or more pages as per requiremnt for each medicine)

NAME OF MEDICINE RECEIPT ISSUE

DATE Quantity In Stock

Date of

Issue

Issued toMention Bed no amp

quantity (in bracket) (For

Outdoor cases give Regd No)

Balance Signature

24

Annexure -F

OUTDOOR FREE MEDICINE SLIP In Duplicate

Name of Patient Registered No Date

Sr no Name of Medicine Quantity

Seal amp sign of doctor

25

Annexure-G

TREATMENT CARD

WARD NO

NAME OF PATIENT BED NO DATE amp TIME OF ADMISSION DATE amp TIME OF DISCHARGE

DATE MEDICINES PRESCRIBED SIGNATURE

26

ANNEXURE -H

PROFORMA FOR BREAKAGE amp LOSS

NAME OF OFFICEINSTITUTION DATE PLACE

SRNO NAME amp

DESCRIPTION OF ARTICLE

COST DATE OF PURCHASE

REASON CAUSE OF BREAKAGE

RECOMMENDATION OF INVESTIGATING AUTHORITY

Signature

Orders of the Competent Authority

Signature

27

Annexure ndash I Loss- Procedure for Reporting

1 The exact nature of the defalcation 2 The full extent of loss 3 The actual period covered by the defalcation 4 The defects in the negle c t o f r u le s by w hic h the loss was rendered possible

and circumstances which facilitated the defalcation 5 The names of the officials held personally or technically directly or

indirectly and wholly or partially responsible for the irregularity c o m m i t t e d i n t h e c a s e

6 Whether the c a s e a s b e e n J u d i c i a l l y t r i e d i n a c o u r t o r n o t i f s o c o p i e s ( i n duplicate) of the Judgment may please be furnished Copy of police report may also be furnished

7 The remedial measures adopted as safeguards against the losses hereafter 8 The prospects of re covery of the loss and he action taken to effect

recovery together with the amount recovered 9 Head of Account to which the Loss is debitable may be informed

Signature of Head of Office with seal

NoteA copy of this report is to be sent to AGMPThis is as per M P Finance Code Vol I

28

STORAGE AND STOCK MANAGEMENT

29

Foreword

The New Drug Policy 2009 is being implemented in the State of Madhya Pradesh

In order to have a proper procedure for Storage maintenance and expiry management of the drugs it is necessary to follow Good Storage Practices with Standard Modules for pharmacistStore keepers

Proper guidelines on Storage Practices can lead to better Stores and inventory upkeep with medicines being properly stored in racks with proper cleanliness and hygiene

This is a step towards storage maintenance and expiry management at the various stores in the state Looking forward to see that the heads of all health facilities take benefit from this module

D ir e c t o r M e d i c a l S e r v i c e s

30

INDEX

Sr No P a r t i c u l a r s P a g e

1 S T O R A G E A N D S T O C K M A N A G E M E N T 4

1 Quarantine and checking of stocks 11 Quarantine area 12 Checks to be carried out on new stocks

2 S t o r a g e 21 Need for proper storage 22 Different patterns of storage 23 Different means of storage 24 Temperatureclimatic conditions 25 Special storage of supplies 26 Storage and stability of medicines

3 Stock Control and Expiry Monitoring 31 Stock control 32 Stock rotation and expi r y m o n i t o r i n g

4 Other aspects of storage 41 Design of a storage area 42 Cleaning and maintenance 43 Product recalls 44 Returned goods

2 A p p e n d i x 1 Templates of letters for use if found not of Standard Quality [Frozen and expired goods ]

Frozen Drugs-ordered to return to the Suppliers-reg(New drug policy 2009)

Frozen Drugs-ordered to return to the Suppliers- for issue of gate pass after verification reg(New drug policy 2009) Stop instruction-reg(New drug policy

2009) Appendix II Material handling in drug stores

31

3 PROCUREMENT ndash Government Order Relating to

the Management of Stores

(Reproduced for reference material on basic

procedure in decentralized system followed by

Health facilities in 1977)

54

F L O W C H A R T S f o r a BI R D S E Y E V I E W o f

P R O C U R E M E N T

5 5

ACQUISITION OF STORES 6 1

PLACING OF ORDERS 6 2

RECEIPT OF STORES 6 2

CUSTODY 6 3

ISSUE OF STORES Maintenance of Stock Books

6 3

PROCEDURE OF INDENTING FOR WARD amp OTHER SECTIONS OF THE INSTITUTION

6 4

HOW OFTEN TO INDENT 6 5

EMERGENT INDENT 6 5

HOW TO INDENT 6 5

KEEPING OF RECORDS IN WARDS A N D S E C T I O N S

6 6

ACCOUNTABILITY OF DRUGS BROUGHT BY THE PATIENT OR RECEIVED IN DON A T I O N BY T H E WARDSECTION _IN - CHARGE

6 7

RESPONSIBILITY OF STORES AT VARIOUS LEVELS

6 7

DISTRIBUTION OF MEDICINES FROM OUTDOOR DEPARTMENT

6 7

LOSS BREAKAGE DAMAGE ETC 6 8

PROCEDURE FOR WRITING OFF STORES 6 9

DISPOSAL OF WRITTEN OFF ARTICLES 7 1

FORMATS TO BE USED 7 3 - 81

32

STORAGE AND STOCK MANAGEMENT The expiry periods of pharmaceutical products have meaning only if the products are stored under proper conditions otherwise products are likely to lose their potency before the actual date of expiry

A pharmacist is a vital link in the distribution chain for pharmaceutical products The medicinal products remain for a long period during the distribution cycle at the wholesaler and at retail pharmacies It is therefore very important to maintain proper storage conditions in these units

Every community pharmacy however large or s mall needs to store and manage its medicine stocks effectively There must be systems to ensure

middot bullbull Secure storage middot bullbull Clean and correct environmental conditions during storage middot bullbull Accurate and effective record keeping middot bullbull Effective stock rotation and expiry monitoring middot bullbull Effective fire and theft prevention middot bullbull Effective rodent pest control

For easier un derstanding this module has been divided into the following sections

1 Quarantine and checking of stocks 11 Quarantine area 12 Checks to be carried out on new stocks

2 S t o r a g e 21 Need for proper storage 22 Different patterns of storage 23 Different means of storage 24 Temperatureclimatic conditions 25 Special storage of supplies 26 Storage and stability of medicines

3 Stock Control and Expiry Monitoring 31 Stock control 3 2 S t o c k r o t a t i o n a n d e x p i r y m o n i t o r i n g

4 Other aspects of s t o r a g e 41 Design of a storage area 42 Cleaning and maintenance 43 Product recalls 44 Returned goods

33

1 QUARANTINE AND CHECKING OF STOCKS

11 Quarantine Area D r u g S t o r e pharmacies receive stoc k s f r o m su pplie r s a c c or d ing to pur c h a se o r d e r s T he stock that is received must be visually checked for quality and quantity The stocks must be kept in a separate area until the checking is done to avoid intermixing with existing stock This necessitates the presence of a separate area within the pharmacy w h e r e i n t h e storage and other checking of stocks can be performed This area is called the QUARANTINE AREA This area should be marked and identified adequately to distinguish it from other areas

The area may be marked using different means 1 ) A s m a l l board saying Quarantine on a separate table used exclusively if it is in the middle 2) A board on the wall if the table on which the quarantine stock is placed is against the wall

middot Stock received from wholesalers should be immediately transferred t o t h e Quarantine Area

middot In the Quarantine area the stock may be stored on racks shelves or in cupboards to prevent ingress of moisture dirt and other contaminants

middot Regular stocks from the pharmacy should not be left kept in the quarantine area Special care has to be taken in case of refrigerated medicines supplied by the suppliers so tha t the y do not remain in the quarantine area for long periods of time They should be immediately checked on receipt and transferred to areas for refrigerated storage s o a s to maintain the cold chain bull

Advantages of having a separate Quarantine Area middot Avoids cross mixing of newly arrived stock from existing stock till it is checked middot Lays stress on checking the quality of the stock received middot S to ck checking ensures t hat defective andor expired goods do not enter the storage areas

34

bullbull

bullbull

12 Checks to be carried out on new stock

Unpacking and checking stock

Supplies received should be unpacked and checked in the quarantine area Staff doing the checks should be adequatel y trained in what they have to check when stock arrives

Checking should be seen not simply as counting the units received but as a part of the quality assurance system bullThis should include middot Visually inspecting the packaging middot Checking the integrity of containers middot V erifying the completeness and leg ibility of la b e ls ( a ppr o ve d dr u g name strength any special storage instructions and expiry date)

bull

The expiry dat e should be checked to ensure that there is adequate shelf life remaining

Supplies should be individually checked using a checklist 35

Checklists

36

The wholesaler supplying the product should be notified immediately in case of any discrepancies ( and the details should be recorded in a register) and sent in a written format to the supplier It should include middot Missing boxes or cartons middot O p en tampered boxes or cartons middot Missing supplies middot Differences in the actual quantity and the quantity shown on the packing middot Additional medicines that had not been ordered but have been supplied middot D a m a g e d b r o k e n o r p oor quality medicines middot Any other discrepancies

The purchase invoices are an important aspect to be considered The invoiced documents should be signed and filed for reference as per the Drugs and Cosmetics Act and retained for at least 3years

If the wholesaler supplies medicines as an emergency without a bill or against a delivery challan

middot The supplies should be checked for integrity and inspected for damage middot The details of supplies received should be recorded middot The supplier should be asked t o send the bill as early as possible middot When the bill is received it should be checked against the details recorded and anomalies if any should be reported to the supplier

To keep a track of the received stock maintaining a S t o c k R e c o r d C a r d c a n b e very useful The entries in the stock record card can be made while checking the stock received STOCK BIN in the stores should have Stock record card

Maintaining a stock card for every product may not be very practical for a retail pharmacy however it could be maintained for costly medicines Nowadays it is much more practical and easier to maintain records using computers

The pharmacist should ensure that medicines manufacturedmarketed by a company are received only through an authorized distribution network of that company This is important to prevent spurious and counterfeit drugs from entering the pharmacy

37

2 STORAGE 21 The need for proper storage The storage of medicines and other products is an important requirement of Good Pharmacy Pr actice Appropriate storage of medicines is essential -

middot bullTo ensure that the potency is maintained middot bullTo prevent deteriorationspoilagedegradation middot bullTo ensuremaintain physical integrity

To ascertain that the quality and safety is maintained throughout their shelf life Storage requirements need to be considered on 2 aspects

a) Integrity of medicines Medicines should be stored in such a way so as to maintain their integrity and potency middot Maintain the right temperature required middot Protect from excessive humidity middot Keep medicines away from direct sunlight middot Protect from pests and rodents

b) Physical location middot Should be easy to locate middot Accessible middot Orderlysystematically placed

2 2 D i f f e r e n t p a t t e r n s o f s t o r a g e The pharmacist could follow any of the different patterns of storage The pattern of stora ge should be selected in such a way that it facilitates speedy and efficient dispensing of medicines

The pattern of storage could vary with each pharmacy experience usual practiceroutine of staff and the person-in charge and also depending on space av ailable turnover etc (i) The medicines could be stored c o m p a n y w i s e ie the medicines manufactured by one company should be grouped together and kept in one place Within each company shelfshelves the medicines may be placed in alphabetical order for easy and quick placement and removal Also bottles tubes boxes etc may be segregated within that shelf

38

(ii) The medicines may also be stored in a lphabe t ic al o r de r ie they are placed in order from left to right based on their name The first letter of the name is used to g r o u p t h e m e d i c i n e s t o g e t h e r a n d k e e p t h e m i n o n e l o c a t i o n I n s o m e p h a r m a c i e s a l l t h e strip packing are placed in drawers or boxes in alphabetical order each box or drawer containing strips of one particular alphabet This system ensures that the strips always remain e n c l o s e d i n t h e b o x e s d r a w e r s a n d a r e n o t e x p o s e d t o d u s t T h e d i s a d v a n t a g e i s that it might lead to mix -u p o f strips in the same drawer and it may cause a problem incase of similar looking strips in which case a wrong medicine may be dispensed Secondly cut strips lying around in the drawer may lose their identity if the batch n u m b e r andor expiry date is not seen on the cut portion of the strip

39

(iii) The medicines may be stored according to their therapeutic class ( e g a n t i b i o t i c s anti asthmatics or anti hypertensives) ie the medicines are kept together based on their pharmacological or therapeutic action

(iv) The medicines may be stockedsegregated according to dosage forms eg l i q u i d s (bottles) solid oral dosage forms eye drops rotacaps ointments etc all stored on separate shelves

Always Remember I Storage of prescription medicines should preferably be separate from OTC medicines OTC medicines especially those that a r e a d v e r t i s e d m a y b e d i s p l a y e d f o r c l i e n t s t o select or to ask questions about [OTC-O v e r t h e c o u n t e r ] II Storage according to temperatures is a must no matter which pattern of storage is followed Also within a particular storage area segregated storage may be maintained In a refrigerator for example medicines may be stored in trays racks and the freezer according to the temperature required

40

Whatever pattern of storage is selected all the personnel should ensure that middot The stocks are stored in an orderly manner middot The medicines are kept back in the same place from where they were removed middot All medicines are arranged neatly once in a while

middot The personnel should be careful while storing the medicines middot They should not throw the medicines haphazardly 23 Different means of storage

middot Within each temperature and security zone medicines must be stored so that they are easily accessible and protected against damage

middot Basic means of storage include shelves racks and drawers middot To prevent dust from entering the shelvesracks it is ideal to have glass

shutterssliding glass doors This can however be disadvantageous because accessibilityspeed is hampered in removing a product from the shelf because the glassshuttersliding glass has to be

41

opened m o v e d e v e r y t i m e a p r o d u c t h a s t o b e p i c k e d u p U s e o f a i r c o n d i t i o n e r s f o r t h e p h arm acy with a closed door at the e n t r a n c e o r a n a i r c u r t a i n c a n r e d u c e t h e d u s t problem In such cases the shelvesracks may be left o p e n

bull

middot Direct storage of cartons on the floor should be avoided because besides being an unhealthy practice the contents may also be damaged by moisture bull

middot Store medicines preferably in shelves with glass shutters for visibility middot Closed shelves further prevent dust from going in especially in India where most

pharmacies are located along busy roads middot Some medicines have to be refrigerated or stored in a cool or cold place Having a

refrigerator or two (as per the need of the pharmacy) is essential to store suc h medicines at temperatures mentioned on the label bull

42

Refrigeration middot All cold chain equipment should meet required standards middot Improvement in refrigeration technology has provided frost -free refrigerators

Pharmacists should opt for frost-free refrigerators as they are easy to maintain and protect printed packaging materials Conventional refrigerators may cause water falling from trays below the freezer on medicines stored in the refrigerator thus causing soggy labels

middot bull Frost-free refrigerators also provide separate and large compartments for the freezer portion (required for storing medicines needing sub-z e r o t e m p e r a t u r e ) and the main storage area with separate doors so that opening one door does not disturb the storage temperature in the other compartment

Care should be taken to keep the refrigerator on 24 hours a day It should not be switched off after working hours It is advisable to have an inverter connected to the refrigerator so that the refrigerator re mains working even when there is a power outage

middot The refrigerator door should be closed tightly middot The refrigerator door should not be left open for too long middot Space should be left between medicines stored in a refrigerator to allow air to

circulate middot The ref rigerator should be placed about an arms length away from the wall

This will increase air circulation thus not affecting the cooling within the refrigerator

middot Vaccines should not be stored on refrigerator door shelves as they are exposed to warmer temperatures each time the door is opened Vaccines should always be stored on the middle shelves of the refrigerator

middot Refrigerated medicines should not be left out of the refrigerator for more than a few minutes

43

middot Consumable products like juices energy drinks e t c s h o u l d n o t b e s t o r e d a l o n g with medicines in refrigerators If required they may be kept in a separate refrigerator

middot An adequate number of refrigerators should be planned to store the entire stocks requiring refrigerated storage

middot Adequate procedures should be followed for defrosting cleaning and maintenance of refrigerators

middot Icefreeze packs should be kept in the freezer compartment so that they can be used for transporting cold temperature medicines The packs can be given to clients along with the medicines requiring cold temperature storage so that the temperature is maintained till the client reaches home and can then put the medicines in a refrigerator) Freezer packs can also be used to keep medicines temporarily in case there is a power outage or refrigerator breakdown

Activity

Prepare a SOP (Standard operating procedure chart) for cleaning a refrigerator Discuss it with your staff finalize its maintenance once a month through AMC -A n n u a l Maintenance contract CMC - Comprehensive maintenance contract and put it up on the pharmacy refrigerator Put the Purchase Order details name of manufacturer Phone of Service Engineer and a register to login the Machine service and down timeService reports may be maintained properly

Refrigerator monitoring and maintenance

middot bullIt is important to carry out routine monitoring and maintenance of the refrigerators and to organize an effective repair system

middot bullThe temperature in the refrigerator must be monitored and recorded routinely at least once a day

middot Any breakdown must be reco rded including the period during which the medicines were exposed to uncontrolled temperatures Medicines may then be kept or discarded depending on the problem guidelines or the manufacturers advice

middot Cold chain monitor cards and devices in or on packages that change color or otherwise alert staff to potential damage assist in monitoring (These are likely to be introduced in India soon)

middot It is essential to have a contingency plan in place before a refrigerator breaks down An arrangement can be made to move the contents to a private refrigerator elsewhere in the community or to obtain a regular supply of ice packs until the defect is rectified

Put filled water bottles in the bottom half of the refrigerator door in order to provide cooling in the refri g e r a t o r w h e n t h e r e i s a p o w e r o u t a g e T h i s m i g h t t a k e c a r e o f t h e temperature when there is no current for a couple of hours If the power outage is expected to last for several hours special arrangements such as an inverter UPS have to be made to keep the refrigerator constantly running in the absence of electricity middot Defrost the refrigerator in case of excessive ice formation and preferably at regular

intervals Keep a record of the same

44

2 4 T e m p e r a t u r e c l i m a t i c c o n d i t i o n s

i) Temperature control middot The medicines in a pharmacy need to be stored at appropriate temperatures to

maintain their stability middot An air-conditioned environment where temperature can be controlled is

recommended for pharmacies Air conditioning offers the option of setting the t e m p e rature as per requirements

middot bullIt is ideal to have an air conditioner to maintain the temperature below 25 C as most medicines require storage below this temperature Secondly this temperature is pleasing to both the staff and the visiting customers too

middot In the absence of an air conditioner circulating fans may be used middot This need is felt even more in certain parts of India where temperatures soar above 45

C and some areas where it falls to sub zero temperatures In such cases temperature maintenance is essential to prevent deterioration of medicines due to unnecessary exposure to drastic temperature fluctuations

middot This need is felt even more in certain parts of India where temperatures soar above 45 C and some areas where it falls to sub zero temperat u r e s I n s u c h c a s e s temperature maintenance is essential to prevent deterioration of medicines due to unnecessary exposure to drastic temperature fluctuations

i i ) Humidity or moisture control Moisture or humidity can adversely affect the stability of me dicines such as tablets capsules powders

45

Gelatin capsules become soft and swell on absorption of moisture The drug content of tablets may undergo surface hydrolysis The presence of moisture may encourage the growth of microbes It is therefore essential to control humidity

To reduce the effect of humidity the following suggestions may be followed -middot Open the windows to allow air circulation Use a fan to circulate fresh (outside) air middot In humid climate a dehumidifier is useful for preventing mo i s t u r e d a m a g e ( i n t h e absence of an air conditioner) middot For bulk containers of tabletscapsules do not keep the container open for a long time and replace the lid or closure immediately after taking out the required number of medicines for dispensing middot Do not allow the medicines to touch the floor or the walls The walls may be damp and may cause moisture absorption damaging the product

middot Calibrated thermometers and manometers can be used to detect temperature and humidity in the pharmacy

middot Periodici t y of checking the temperature should be fixed middot The climatic conditions should be recorded and documented middot Temperature charts should be available for ready reference

Documentation is one of the core activities for achieving and maintaining quality It is one of the most essential components of validation Temperatures in various areas

46

including refrigerators should be recorded at a predetermined periodicity usually daily at the hottest time of the day and such documents should be preserved i i i ) Storage conditions A number of storage conditions are mentioned on the labels of medicinal products These conditions have to be properly interpreted and appropriately complied with

According to the Drugs and Cosmetics Rules 1945

1 The term cool place means a place having a temperature between 10 C and 25 C

2 The term cold place means a place having a temperature not exceeding 8 C In case of storage conditions for specific products please refer to Schedule P The Drugs and Cosmetic Rules 1 9 4 5

The Indian Pharmacopoeia specifies the following storage conditions -

Wherever the condition for storage is not specified medicines may be stored under normal temperature In a country like India however where normal temperatures soar to h i gh temperatures it is recommended that medicines be stored in a cool place

Activity Prepare a list of the storage requirements mentioned on the label of about 20 products in your pharmacy and check if the temperature is maintained

47

25 Special Storage o f s u p p l i e s If the product has no special instructions normal storage conditions apply This means storage in dry clean w e l l -ventilated premises at temperatures of +15 C to +25 C or depending on the climate up to +30 C (WHO1990) Storage instructions are product specific Different brands of the same generic drug may have different storage requirements as they may have different packaging or formulations It is essential to follow the product manufacturers storage instructions to the maximum extent possible Less stable medicines must be stored in specific conditions to maintain their quality or potency

The following products require special storage facilities

middot Products that must be kept frozen (usually vaccines and sera) middot Products sensitive to h eat an d r e q uir in g r e f r ig e r a tio n ( +2 C to +8 C) middot Products that have reduced shelf life at uncontrolled room temperature and need

mechanical ventilation or air conditioning middot Flammable products that require separate fireproof premises middot Products prone to theft o r m i s u s e

Products needing storage in a controlled environment -

The usable shelf life of the following products may be reduced if stored at uncontrolled humidity or at room temperature in hot climates -

middot Some injectables (eg adrenaline) Most injectable preparations are less stable than solid oral forms (tablets and capsules) Injectable preparations in solution are particularly unstable Many injections must be protected from light as well as heat

middot Intravenous fluids (particularly if packed in p lastic containers) middot Some suppositories pessaries creams and ointments These products may melt at

temperatures greater than 30 C Once this happens it is not advisable to use them because the active ingredient in the formula may get unevenly distributed

middot Products containing rubber latex cellulose or some plastics Condoms most sterile disposable medical devices and surgical products such as syringes needles and catheters require protection from excessive humidity and strong light and heat Any o f these conditions may make products brittle stained amp unusable Sterility cannot be assumed if packaging is damaged

In hot climates these products should be stored in the coolest place possible preferably with air conditioning or air circulation fans

48

Products needing freezing or refrigeration-middot Vaccines blood products and many other medicines lose potency if kept even for a

brief period at temperatures outside the recommended range For these products the cold chain must be maintained at every stage of the distribution system

middot Freezing is as damaging as high temperatures for some products including injectable contraceptives ergometrine insulin adrenaline and the DPT DT TT and Hepatitis B vaccines Such products therefore sho uld not be allowed to freeze (not be kept in the freezer compartment)

middot Short periods at room temperature (during transportation or local distribution for instance) may be acceptable for many products (such as ergometrine a n d i n s u l i n ) e v e n t h o u g h s u c h e x posure can to some extent reduce shelf life Other items such as vaccines should always be transported in cold boxes

Storage of insulin injections-

middot Insulin should always be stored in a refrigerator at the recommended temperature of 2 -8 C

middot Insulin should not be kept in the freezer compartment of the refrigerator middot Insulin should ideally be stored horizontally middot It should not be exposed to sunlight or excessive heat middot Insulin suspensions should not be used if the suspension cannot be properly

resuspended due to cake or clump formationbull

Controlled drugs -Narcotics (for example Pethidine injection morphine preparations) and other specified drugs that may be abused are governed by special legislation and regulations The following security measures are suggested in the pharmacy -middot A safe or reinforced double locked cabinet fitted with a light (preferably with a red

bulb) that comes on when the door is opened

49

middot A special register recording details of each receipt or issue with 2 signatures physi cal counting of medicines after each entry and signatures at handover takeover

middot Independent audit (by supervisors and drug inspectors)

Products prone to theft abuse or misuse -

Some medicinesproducts are particularly prone to theft abuse or misuse These include expensive medicines (eg insulin) certain antibiotics and products prone to abuse or misuse like psychotropics etc

Such medicinesproducts should be stored adequately They require stricter record keeping and more frequent stock taki ng than others Periodic audits should be carried out to check for consumption against actual recorded use (registers prescription records stock records etc) to expose any theft or misuse bull26 Storage and stability of medicines Medicines are not stab le indefinitely They are stable for a specific period of time sometimes for a brief period Poor storage conditions accelerate the drug degradation (decomposition) Temperature light and moisture are the most important contributing factors for drug instability It is important to identify and be aware of the potential for instability There is a need to comply with storage requirements to ensure quality medicines for patients It is also important to offer advice to patients too about appropriate storage o f medicines at home The dispensing label should state the storage condition required and be backed up by a verbal reminder especially where special storage is required bull

50

In case stability and storage problems are seen with formulations they should be reported immediately to the representative of the manufacturer and taken out of circulation till the stability problems have been resolved

The pharmacist can easily detect stability problems when products show change in appearance color odor settling of the product contents breaking of emulsions melting of creams oozing of contents from the containers and any such physical changes

3 STOCK CONTROL AND EXPIRY MONITORING 3 1 S t o c k C o n t r o l For economic reasons pharmacists do not like to have stock on their shelves for long periods of time The aim should always be to keep stock at a level that will just meet demand Normally most manufactured medicines have a long shelf life Even then it is essential that there is efficient stock rot ation so that the older stock is used first It is also a good practice to check the expiry date as an integral part of the dispensing process When short shelf life products are involved stock levels may have to be modified to prevent medicines regularl y expiring on the shelves

32 Stock rotation and expiry monitoring In order to avoid accumulation of expired and obsolete stock medicines should be stored and issued according to the following guidelines -middot The stock control system must record the ex p i r y d a t e a n d t h e d a t e o f r e c e i p t middot Stock must be stored so that earliest expiring batches are picked and issued first middot The First In First Out (FIFO) system - In this system the stock which is received

first is sold first This system however may not be useful for pharmacies because most of the stocks carry an expiry date For pharmacies the FEFO system is more practical

51

middot The First Expiry First Out (FEFO) system - In this system the stock having an earlier expiry is sold first The stock with longer shelf life should be placed farthest to the back (or at the bottom in case o f sta c k e d b oxe s) T h is is pa r tic u la r ly impor ta n t with products that have short shelf lives such as vaccines some vitamins antibiotics etc and reduces losses due to expiry

middot E x p i r y dates should be noted on the stock record upon receipt Stock nearing expiry should not be accepted unless it can be used before expiry

Computerization and expiry monitoring In the pharmacy computerization facilitates both checking stocks and expiry mo nitoring and helps-bullbullKeeping a check on products nearing expiry bullbullKeeping a check on non- moving and slow moving products bullbullTo facilitate the removal of medicines nearing expiry from shelves in time to send them back to the wholesaler or supplier

Periodic checking for expiry The expiry date for medicinal products is a critical aspect in pharmaceutical dispensing and due importance should be given to it Periodic checking for expiry of medicines will ensure that the patient will never receive products that have crossed their expiry date During periodical checking of expiry the personnel involved should remove medicines that are nearing expiry bullbullIn -house threshold periods should be set and followed for retrieval of such medicines from the shelves bullbullSuch medicines should be stored separately These should either be dispensed immediately (thus ensuring that they are used before the expiry date) o r t h e y s h o u l d b e returned to the suppliers bullbullA separate area should be designated (cupboard or shelf)marked[FROZEN ZONE] which is adequately marked EXPIRED GOODS- NOT FOR SALE to store all expired stocks FROZEN ZONE

52

Remember Expired medicines are a NATIONAL WASTE So stock only what you can sell Avoid expiries save precious medicines for the nation

Treatment and disposing of expired medicines bullbullProcedures need to be in place for the treatment of expired medicines bullbullThe expired medicines need to be collected and be sent back to the supplier or company for appropriate disposal bullbullRecords must be maintained for expired medicines and how they are disposed off bullbullIn case of medicines that are not returnable to suppliers procedures for disposal need to be followed by the pharmacy in conjunction with the FDA The following procedure can be followed if medicines cannot be returned to suppliers ( T h e b a s i c p h i l o s o p h y of appropriate disposal is to prevent their re- circulation and use) bullbullC u t t h e c o n t ainer in such a manner that the label is also cut In case of tablets and c a p s u l e s d e s t r o y them by disposing them in a bucket of water bullbullUse landfill procedures (deep burial into the ground as per stipulations of Medical Waste Disposal Act prevalent in the respective state) bullbullPour the liquids into the sink and wash away with sufficient quantity of water bullbullKeep a record of such disposal with full details of medicines destroyed Although these measures are usually adopted care has to be taken with such tr e a t m e n t a s studies have shown that flushing of medicines has resulted in tracessmall quantities of medicines being found in waterways and groundwater having potential health and environmental effects

4 O T H E R A S P E C T S 41 Design of storage areas The following important factors need to be considered in design of storage areas -middot The retail outlets in hot areas in summers should be air-conditioned Similarly in

a r e a s o f e x t r e m e c o l d t h e p r e m i s e s w o u l d r e q u i r e w a r m i n g e s p e c i a l l y i n w i n t e r s t o maintain cool temperatures The placement of air -conditioners and heating devices should be such that medicines are not directly exposed to the cold or heat

middot Due consideration should be given to storage requirements of formulations while designing shelves and cupboards in retail outlets Sufficient shelf height should be provided so that all liquid products can be stored vertically As far as possible the shelves should be covered with glass panels to protect medicines from dust and p r e v e n t r a p i d f l u c t u a t i o n s i n temperature

middot Medicines should be stored according to the storage instructions on the labels bullIt is ideal to have a door at the pharmacy entrance to prevent dust from coming in as well as reduceprevent cooled air from going out This may not however be considered feasiblepracticable by many pharmacy owners for fear that clients may not enter the pharmacy because the door may act as a barrier An air curtain is a good alternative to a door

middot There should be minimal direct sunlight falling on the products Particular consideration should be given to premises directly facing the sun

middot bullThe arrangement of lighting in the interior of the premises should also be in a manner that the lights are not focused on the products It has been shown that light causes not only chemical damage but also can catalyze physical changes like moisture uptak e by the products Care should be taken to ensure that only diffused light falls on them

53

middot As far as possible provision should be made for a temperature and humidity indicator device in a pharmacy These devices are now easily available

middot Stability studies o f m e d i c i n e s p a c k e d i n b l i s t e r s h a v e r e v e a l e d t h a t i f t h e s e a r e exposed to light they tend to absorb moisture It is therefore necessary to store them in suitable cartons so that the blisters are not exposed to light Pharmacists should do this even if the manufacturer has not provided cartons

middot Light and temperature sensitive products should not be stored on counters where the light is intense or direct and there is no protection from temperature and humidity

42 Cleaning and maintenance i) Cleaning of storage areas

The storage areas of the pharmacy should be cleaned periodically and cleanliness should be maintained at all times The Standard Operating Procedure for cleaning should be designed and followed accordingly Schedules for cleanups should be laid down and adequate cleaning equipment should be made available

Tips for maintaining cleanliness middot Provide clean pieces of cloth for wiping at various locations in the pharmacy

Replace with clean cloth at regular intervals middot Keep separate pieces of cloth for floors shelves and medicines middot Use a disinfectant andor soap solution to clean floors middot Ensure removal of dust and prevent accumulation of dirt middot Ensure removal of cobwebs middot Use a vacuum cleaner for cleaning areas not easily reachable middot T a k e c a r e t h at breakages are handled and cleared effectively middot Observe the factors leading to waste generation in the pharmacy and take appropriate

measures to tackle the problem middot Record all cleaning procedures performed and maintain all the documents required

For ex a m p l e -bullbullThe floor of the pharmacy may be swept with a broom and swabbed with soap water every morning bullbullThe floor may be swabbed with a disinfectant every week bullbullThe entire premises including shelves and cupboards may be cleaned with a cloth (to remove dust and to check for medicines approaching expiry date or expired medicines) every three months bullbullAll the steps followed should be r e c o r d e d

The floor shelves drawers have to be cleaned and a check should be kept on dust cobwebs spillages due to breakage etc It is therefore essential to have SOPs for cleaning laying down cleaning frequencies allotting responsibilities and maintaining a daily record in the logbook to document all these activities

54

While cleaning dust settled on dosage forms like bottles tubes etc should be removed Before dispensing the products should also be wiped to remove any dust settled during storage

For refrigerators bullbullDefrosting and cleaning should be done at regular intervals bullbullSwitch off the refrigerator while cleaning bullbullCleaning should be done quickly and stocks put back immediately

i i ) Pest control Pests are a serious problem in India where insects reptiles and rodents (eg cockroaches l i z a r d s r a t s s i l v e r f i s h (Deemak - in Hindi ) etc) may find access to the pharmacy storage areas Insects like ants and borer ants may often attack wood in the pharmacy causing d am ag e to shelves cupboardsPest c ontr o l in a p h a r m a c y c a n b e a d i f f i c u l t t a s k b u t t o avoid possible contamination and physical damage to stock it is necessary to keep pests out of the pharmacy premisesPest control measures should be implemented with proper p r e c a u t i o n s t a k i n g u t m o s t c a r e t o a v o i d contamination of medicines

55

Th e following pest control measures c a n be ta ke n f r om tim e to tim e -bullbullRat bait and traps can be placed at various locations bullbullInsecticutors can be used on a permanent basis bullbullInsecticidal sprays and repellants can be used from time to time

i i i ) Fire precautions

Combustible trash such as cartons boxes and other packing waste must not be allowed to accumulate in the store Waste should be deposited in appropriate waste bins and be d i s p o s e d o f f o n a d a i l y b a s i s

F i re detection and fire fighting equipment must be maintained and regularly inspected The pharmacy personnel should receive adequate training in fire fighting techniques and emergency actionFire prevention measures should include a prominently displayed ldquoNoSmokingrdquo sign careful handling and disposal of combustible waste materials and checking of electrical connections at regular intervals

iv) Security middot Doors shutters of the pharmacy should be strong and be fitted with secure locks middot Counters should be designed so that unauthorized personnelclients do not have

access to areas where prescription medicines are stored Access to such areas should be restricted to the pharmacy staff

middot All the pharmacy staff handling supplies should be accountable for their ac t i o n s

56

middot bullSpecial care must be taken in case of Schedule X and manufactured drugs (under NDPS Act) Such medicines should be kept under lock and key and the key should be kept with the Chief Pharmacist or i n h i s a b s e n c e t h e s e n i o r p h a r m a c i s t

v) Breakagespillage and damaged product Products that have been damagedspoiled during storage and handling spillages and broken glassware should be disposed off according to procedures laid down by the pharmacy Broken and damaged products s h o u l d b e p l a c e d i n a segregated area to be returned to the supplier

vi) Inspection Senior staff should inspect all pharmacy areas regularly The shelves and drawers should b e c h e c k e d d a i l y f o r signs of pests and dust Ceiling and walls should be checked for dirt and cobwebs Stock should be checked on a regular basis for deterioration due to climatic conditions

43 Product recalls Products found to be defective should be quickly recalled (withdrawn from the market) The instructions are generally issued either by the manufacturer or the regulatory agency The level of recall is determined by both the degree of risk and the extent of distribution of the product and in India is mainly directed at the distribution chain

On receiving the details of the defective substandard spurious batchbatches of a medicine to be recalled from the manufacturer or the stockist or the FDA the pharmacy should immediately check if the particular b a t c h i s i n s t o c k a n d i f s o s u s p e n d i t s s a l e immediately

Similarly if the regulatory authority in the country bans a particular medicine or FDC the pharmacy should immediately check and remove all the different brands of that particular medicine under consideration

The details of medicines and their batches to be recalled should be available in the q u a r a n t i n e a r e a w h e r e stocks are received and checked This is to ensure that such medicines do not come into the pharmacy

middot The pharmacy should develop SOPs for recall of medicines middot The pharmacy staff should be immediately informed about such medicines and

the details should be displayed in writing in a prominent place in the pharmacy middot Rapid action helps avoid unnecessary exposure to such medicines once the

problem has been d e t e c t e d middot The progress of the recall procedure in the pharmacy should be monitored every

few days to ensure complete compliance middot All stocks of the recalled products should be stored separately from the saleable

stock These can be stored in the expiry cupboard segregated from the expired goods and be appropriately labeled ldquoRecal l e d G o o d s - Not for Salerdquo

The supplier should be notified and asked to replace defective products middot All the details of the procedures followed should be duly recorded in a Recall

Register maintained specially for the purpose The register should include d etails such as -middot Date of the recall middot Nam e of the product

57

bullbull

middot Details of the product (name of manufacturer batch number expiry date) middot Nu m b er of units purchased sold a n d sto c k in ha nd middot Reason for recall middot Nam e of the supplier to whom produc ts w e r e returned along with the date and quantity middot Name and signature of the designated personnel carrying out the recall procedure and recording details middot Name and signature of the chief pharmacist verifying the recall procedures and recording details 4 4 Returned medicines

Medicines may be returned to the pharmacy by clients due to the following reasons -bull

bullbull Unused medicines bullbull Course not completed bullbull Therapy changed by doctor bullbull Side effects experienced by patient bull

bullbull DamagedDefective medicines bullbull Missing or defaced label bullbull Missing tablets in a stripblister bullbull Leakage in bottles bullbull Leakage in strips bull

bullbull Expired medicines

Appropriate SOPs should be framed and followed for their acceptancerefusal and disposal middot bull For unused medicines returned by clients the p harmacy personnel should verify

that these were purchased from their pharmacy They should then be checked for integrity of the packing the dosage form and the expiry date and verified with the client whether they were stored in appropriate conditions This again is at the discretion of each pharmacy

middot The damageddefective medicines returned to the pharmacy should be taken back and stored separately Existing stock of the same product should be checked for similar defects

middot Expired medicines should be accepted from clients at the discretion of the pharmacist and be immediately shifted to the expired goods cupboard These can be stored segregated from the pharmacys own expired goods and be appropriately labelled ldquoExpired Goods returned by clients- Not For Salerdquo

It is advisable not to accept returned medicines requiring cold chain storage (refrigeration) because it cannot be ensured that the cold chain was maintained when the medicines were in the hands of the patientclient middot Appropriate adjustments in t he stocks should be made for medicines

returnedexchanged to update the inventory middot The medicines should then be returned to the respective shelves middot A lsquoReturned Goodsrsquo register needs to be maintained to record all details of returned

medicines

R egister should include such details as-

58

middot N a m e o f t h e p a t i e n t middot Nam e of the product and quantity r e tu r n e d middot Product details such as the batch number and expiry date middot Condition in which received middot Reason for returning products middot Compensatory measures taken wi t h r e s p e c t t o c l i e n t middot Action taken with respect to product middot Name and signature of the personnel accepting the returned medicines and recording details middot Name and signature of the chief pharmacist verifying the recorded details

What the pharmacist would have learnt from this module The storage of medicines is a critical factor in the distribution cycle bullbull Stocks received by the pharmacy should be quarantined in a separate area and necessary checks s h o u ld be performed to ascertain the qua lity a nd quantity of stocks received bullbull Whatever pattern and means of storage used the products should be stored so as to maintain their potency and integrity bullbull Storage conditions should be monitored and maintained on a regular basis bullbull Optimum stock levels should be maintained and regularly monitored for expiry bullbull The design of storage areas should facilitate appropriate storage of medicines bullbull Cleanliness should be maintained in the pharmacy bullbull Adequate measures should be taken in case of returned medicines and recalled products

Optimum storage of medicines is mandatory whether at the distribution stage at the pharmacy or ultimately within the homes of patients The pharmacist has an important r o l e t o p l a y i n t h e s t o r a g e o f m e d i c i n e s i n m a i n t a i n i n g d r u g p o t ency and efficacy and thus facilitating optimum therapeutic benefits Good Pharmacy Practice - IPA -CDSCO - WHO Appendix I Quality Assurance Templates of letters for use if found not of Standard Quality [Frozen and expired goods ]

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated To Name of the Supplier with address

Sub Not of Standard Quality GoMP-Supply of Drugs and medicines-(Codename) Return of Stocks to the Suppliers-reg(New drug policy 2009) Previous letterinvoice ref Sl No Drug Code Drug name

Manufacturing date Expiry date

Supplier address

B a t c h n o

The above items of PO nodated was drawn by the Drug Inspector (Place) on (______________date) as a statutory sampling and declared ldquoNot of Standard

59

Qualityrdquo on -(______________date) by the Government Analyst for the following reasons

- ldquoThe product sample do not confirm to IP specification for (Drug codename with respect to the content of drugrdquo

- ldquoThe product has already been blacklisted by TNMSC on -(______________date) for the failure of (quantity) of batches of drug codenamerdquo

As per the clause of the te nde r d oc um e nt ldquo I f the sa mple s d o not c onf o r m to statutory standardsthe tenderer will be liable for relevant action under the existing laws and the entire stock in such batch should be taken back by the tenderer within a period of 30 days o f t h e r e c e i p t o f t h e l e t t e r f r o m t h e v e n u e

The stock shall be taken back at the expenses of the tendererthe Procurement Authority have the right to destroy such Not of Standard Quality if the tenderer does not take back the goods within the stipulated time

The Procuring Authority will arrange to destroy the Not of Standard Quality drugs within 90 days after the expiry of 30 days mentioned above without further notice and shall also collect demurrage charges calculated at the rate of 2 per week on the value of the drugs rejected till such destructionrdquo

Hence we regret to inform you that you will have to take back the stocks available of the abovesaid batch at your own cost from the drug stores where you have supplied the above batch

Kindly acknowledge the receipt of this reference at once

P r o c u r e m e n t A u t h o r i t y Seal and Stamp

Copy to Ref No dated

1 ) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated13082010

To

Sub Frozen Drugs-ordered to return to the Suppliers-reg(New drug policy 2009) Previous letterinvoice ref

The following products which were earlier frozen have now been ordered to return to suppliers directly with permission from the State drug Authority In this regard the suppliers have been instructed to take back their failed batch from the drug store of the stores Hence you are now instructed to return the following failed batches to the suppliers by obtaining proper authorization letter and acknowledgements from them

60

Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

Kindly acknowledge the receipt of this reference at once

Procurement Authority Seal and Stamp

Copy to

Ref No dated 2) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated14092010

To

Sub Frozen Drugs-ordered to return to the Suppliers- for issue of gate pass after verification reg(New drug policy 2009) Previous letterinvoice ref

The following products which were earlier frozen have now been released Hence they may be issued Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

Kindly acknowledge the receipt of this reference at once

Procurement Authority Seal and Stamp

Copy to

61

Ref No dated 3) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated

To

Sub Stop instruction-reg(New drug policy 2009) Previous letterinvoice ref

Until further instructions stop issue all the batches of the following item Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

You must intimate the available stock in the stores of the said batch Number to the Procurement Authority immediately Also retrieve quantity if already issued

Procurement Authority Seal and Stamp

Copy to

Ref No dated 4) HOD Procurement Office of

62

Appendix II Material handling in drug stores

Rack approx rates and dimensions

S No

Item Description UOM Approx Rate

1 MEDIUM DUTY RACK SIZE 2900 H X 3090 W X 800 D IN MM (AS PER SPECIFICATION)

Each 2499800

2 MEDIUM DUTY RACK ADD ON UNIT FOR SIZE OF SR NO2

Each 2243100

To locate a Box no 3 Rack no 14 in row3

SAMPLE OF RACK no Bin numbering -------------- S a y R K 1 4 R o w 3 B o x 1 6

SAMPLE LAYOUT of RACKS in a Drug Stores

63

Sample of another warehouse of distribution warehouse system

64

65

Slotted Angle racks with bin cards

66

Plastic Pallets

Plastic pallets ar e l i g h t w e i g h t l o w- c ost and exceed industry standards for strength and durability

NOTE A pallet has bottom deckboards (see sketch) A skid does not have bottom

67

deckboards

Battery Operated Stacker

Electric Stacker Ehh (Manual Push Type) - Manual drive - Lifting electrically with Battery 12 V 88 Ah - For loading and un-loading of trucks - Battery and loading device built - in - Battery charge gauge and charging current gauge Simple and Easy Operation - Lifting and Lowering electrically direct on steering arm - Pulling and pushing through steering arm - Electrically operated relief valve on hydraulic aggregate Safe Operation - Emergency Off Switch - Constant lowering speed - Protection through lowering brake valve - Overload protection through overload brake valve - Load chains covered preventing pinching threat - Electrically interlocking during loading process - Secured battery compartment opens upwardly - Stable buffering of the steering arm in upright position - In accordance with EWG Guidelines 89 240 - In accordance with VBG 12b Prevention of Accidents

Pallet Truck [ Top ]

68

----------------------------------------------------------------------------------------------------------------------------

For Transport Of All Goods On Pallets Safe and Easy Operation - through single hand operation Lifting moving

lowering with steering handle - neutral position of the hydraulic possible - overload pressure relief valve Long Service Life - robust co n s t r u c t i o n

- special hardened axles - hardened chromium plated ram - maintenance free Easy Maneuverability - through rubber steering rollers - nylon fork rollers

A h a n d t r o l l e y

69

Trolley with plastic bins for several items del ivery

70

Digital Weighing balances

Balances amp Scales EF Seriers Precision Electronic Balance

71

1

Ice lined Refrigerators

600 litres refrigrator

72

Walk in cooler

vacuum cleaner

73

XV LOSS BREAKAGE DAMAGE ETC

(A) Any loss of public money departmental revenue of receipts stamps stores or other property held by or on behalf of the Government caused by defalcation or otherwise discovered in an office or institution should immediately be reported by the officer concerned to the head of department through his immediate superior as well as to the Accountant General if the loss exceeds Rs 20000(fig of 1977) (for Proforma see Annexure I)even when such loss has been made good by the party responsible for it Such reports must be submitted as soon as possible and soon after suspicion arises that there has been a loss they must not be delayed while detailed enquiries are made

When the matter has been fully investigated further and complete report should be submitted of the nature and extent of loss showing the errors or neglect rules by which such loss showing the errors or neglect of rules by which such loss was rendered possible and prospects of effecting such recovery

The s ubmission of such a repot does n o t d e b a r t h e l o c a l a u t h o r i t i e s t a k i n g f u r t h e r a c t i o n which may be deemed necessary like handing over the case to the police

Every Government servant should realize fully and clearly that he will be held personally responsible for any loss sustained by the government through fraud and negligence on is part and that will also be held personally responsible for any loss arising from fraud or negligence on the part of any other Government servant to extent to which it may be shown that he has contributed to loss by his own action or negligence

A s s o o n a s s h o r t a g e i n s t o c k o r l o s s i s d i s c o v e r e d a p a r t f r o m r e p o r t i n g t h e m a t t e r a responsible officer should be deputed to investigate the matter

W h e r e t h e r e i s n o l i k e l i h o o d o f a d e l i b e r a t e t h e f t b u t l o s s i s a result of neglect onlythe loss should be made good by the person on whose charge or custody the article lost remained

(B) As soon as damage or breakage of Government property is detected certain steps mentined under should be undertaken-

(a) A p r o m p t t h o ro u g h i n v e s t i g a t i o n i n t o t h e c a u s a t i o n o f b r e a k a g e o r d a m a g e s h o u l d be undertaken by the doctor-i n -charge of the WardSection or by the Head of the Institution

( b ) The investigating officer should draw conclusions as to whether the breakagedamage has been a result of-

(i) C a r e l e s s a n d n e g l i g e n t h a n d l i n g ( i i ) Unpredictable action of the patient for whom the equipment was

being used (iii) Accidental ( i v ) Manufacturing Defect

A report is then prepared in duplicate by person in charge of the article under question on the lsquobreakage and loss proformarsquo (See Annexure H)

16

These reports have to be signed by the investigating officer and are to be then submitted to competent authority for suitable action One copy which is returned is to be kept with the Stock Register In cases where the b r e a k a g e o r d a m a g e i s o f s u c h b i g g e r d e g r e e t h a t s atis factory repairs are not possible a n d if suc h b r e a k a ge o r da m a ge is o f su c h a de gr e e that satisfactory repairs are not possible and if such breakage or damage has been caused-

( i ) B y a G o v t s e r v a n t because of negligent or careless handling cost of the article should be recovered from him and credited to the treasury (ii)On account of reasons mentioned above that is un predictable action of the patient accidental or manufacturing defectthe article could be written offsubject to powers delegated to the concerned for such purpose

(C )Shortages detected during biannual physical verification of the Storeshave to be dealt in a similar manner

(D) it shall be at discretion of the competent authori ty (who is empowered to write off the loss) to reduce the amount of recovery upto 50 of the cost of article provided that before arriving at such a decisionhe has taken into account the following points (a) Normal life span of the article under questi on (b) Period for which it has been in use (c ) Condition of the article at the time of loss or damage and (d) Whether it was on account of careless or negligent act or not

XVI PROCEDURE FOR WRITING OFF STORES

(a) When any Stores become unserviceable otherwise than in ordinary course or by fair wear and tear their value should be treated as loss to the Government and in such cases cost should be recovered from the person responsible for his negligence

( b ) A s t r i c t w a t c h s h o u l d b e k e p t o n t h e m e d i c i n e s w h i ch bear an expiry date and if there is no likelihood of their being utilized locally intimation of the fact should be sent to Directorate of Health services and also to all o t h e r d i s t r i c t s s i m u l t a n e o u s l y s o t h a t t h e y c a n b e p u t t o u s e b e f o r e t h e expiry date In the event such a course is not followed and the Government i s p u t t o l o s s c o s t o f t h e m e d i c i n e i n q u e s t i o n s h a l l b e r e c o v e r e d f r o m t e defaulter

(c) For declaring articles as unserviceable a Committee of three members should be formed in each officeinstitution This Committee should examine each and every article brought before it and should record full reasons for condemning them and also say how the articles condemned have to be disposed of-whether by sale (by public auction) or otherwise

I f t he local Authority is not competent to write off the articles condemned by the Committee it should send the proposal to the higher authority for suitable a c t i o n

17

In Institutions where there is only one doctor a list of articles to be condemned should be p r e p a r e d a n d o r d e r s o n i t b e o b t a i n e d f r o m t h e inspecting authority during inspection

While preparing any list of articles for condemnation details regarding the date of purchase date of receipt period during which it remained in use usual life of the article and its purchase price should be noted against each item

( d ) The condemned articles should not be struck off the Stock Register till the competent authority sanctions its write ndashoff Details of Authority under which the article has been written off should be mentioned in stock register

XVII DISPOSAL OF WRITTEN OFF ARTICLES

Articles like linen should be torn into strips 10cm width so that they could be burnt or given to Government Jails for making carpets

Items like bed -pans bowlsurine po ts etc should be crushed and kept for auction

Brass utensils have also to be crushed to destroy their shape and could be either auctioned or after inviting rates from several dealers could be locally sold to highest bidder

In case when condemned ar ticles have to be sold by public auction they should be stored safely and the Government Auctioneer be intimated In case he expresses his inability to undertake the auction the officer should proceed with the auction departmentally The sale proceeds in either case should be credited to the Treasury as miscellaneous receipts under the Proper head of account

XVIII PHYSICAL VERIFICATION (a) The stocks held by officesinstitutions in various sections should be physically

verified twice a yearin the months o f April and October ( b ) Checking should be done by an officer other than te one who holds the charge of

Stores (c) Verification should be done in presence of officer holding the charge of Stores ( d ) All discrepancies found during the verification should be properly investigated

and accounted for

(j) Any excess detected during verification should be entered in the Stock book as Receipts with the remark ldquo Excess found on verificationrdquo

(ii)any shortage should be noted in issues column of lsquo Issuesrsquo described as lsquoshortage fou n d o n v e r i f i c a t i o n rsquo

XIX ANNUAL STORES ACCOUNT This account should be prepared according to the instruction issued from the department from time to time This should account for the outgoing financial year on the following lines -(a) Cost of the articles under various heads on the last day of the previous

year 18

( b ) Cost of the articles under the various Heads Received during the year (c) Cost of various articles written off during the year under review ( d ) Cost of the articles on the last day of the year or on the firs t d a y o f t h e

financial year following

19

Annexure A WardSection Indent Register No Issued on

Name of institution Page Folio No

Serial no Name of Article Quantity in Stock

Quantity required

Prepared by Approved by Recd by Note-Indenting Officer to sign and affix seal with name and

designation below the last item to avoid additions in one strokeno issues to be made by storesif Issue vouchers of

previous Indent has not been returned back by the WardSection

20

Annexure B Issue Voucher No (printed number)

Supplied to Wardsection Date

Indent no

Serial no Name of Article Quantity in Stock

Quantity required SB No

Stores-in MO Resident in Sign of charge charge WardSection

NurseCompounder Prepared by Recd Approved by by

Note-Indenting Officer to sign and affix seal with name and designation below the last item to avoid additions in one strokeno issues to be made by storesif Issue vouchers of previous Indent has not been

returned back 1st copy-Stores 2nd copy -Wardsection3rd copy-Tobe reurned to sores with Stock book entries

21

Annexure C

STOCK REGISTER FOR DEAD STOCKS

SERIAL NO DATE OF RECEIPT

Article with description

No of pieces Cost Details of

Bill Signature No Disposed

Date of disposal

Manner of Disposal

with Authority

Value realised Signature

1 2 3 4 5 6 7 8 9 10 11 12

P r e p a r e d B y C h e c k e d b y A p p r o v e d b y

Date Designation Name of Institution

22

Annexure D

STOCK REGISTER FOR EXPENDABLE ITEMS Name of article

Date

From where

received with cost

Quantity Signature To whom issued Quantity Balance Signature

1 2 3 4 5 6 7 8

23

Annexure E

Receipt amp Issue Register for WARDSSECTIONS (one or more pages as per requiremnt for each medicine)

NAME OF MEDICINE RECEIPT ISSUE

DATE Quantity In Stock

Date of

Issue

Issued toMention Bed no amp

quantity (in bracket) (For

Outdoor cases give Regd No)

Balance Signature

24

Annexure -F

OUTDOOR FREE MEDICINE SLIP In Duplicate

Name of Patient Registered No Date

Sr no Name of Medicine Quantity

Seal amp sign of doctor

25

Annexure-G

TREATMENT CARD

WARD NO

NAME OF PATIENT BED NO DATE amp TIME OF ADMISSION DATE amp TIME OF DISCHARGE

DATE MEDICINES PRESCRIBED SIGNATURE

26

ANNEXURE -H

PROFORMA FOR BREAKAGE amp LOSS

NAME OF OFFICEINSTITUTION DATE PLACE

SRNO NAME amp

DESCRIPTION OF ARTICLE

COST DATE OF PURCHASE

REASON CAUSE OF BREAKAGE

RECOMMENDATION OF INVESTIGATING AUTHORITY

Signature

Orders of the Competent Authority

Signature

27

Annexure ndash I Loss- Procedure for Reporting

1 The exact nature of the defalcation 2 The full extent of loss 3 The actual period covered by the defalcation 4 The defects in the negle c t o f r u le s by w hic h the loss was rendered possible

and circumstances which facilitated the defalcation 5 The names of the officials held personally or technically directly or

indirectly and wholly or partially responsible for the irregularity c o m m i t t e d i n t h e c a s e

6 Whether the c a s e a s b e e n J u d i c i a l l y t r i e d i n a c o u r t o r n o t i f s o c o p i e s ( i n duplicate) of the Judgment may please be furnished Copy of police report may also be furnished

7 The remedial measures adopted as safeguards against the losses hereafter 8 The prospects of re covery of the loss and he action taken to effect

recovery together with the amount recovered 9 Head of Account to which the Loss is debitable may be informed

Signature of Head of Office with seal

NoteA copy of this report is to be sent to AGMPThis is as per M P Finance Code Vol I

28

STORAGE AND STOCK MANAGEMENT

29

Foreword

The New Drug Policy 2009 is being implemented in the State of Madhya Pradesh

In order to have a proper procedure for Storage maintenance and expiry management of the drugs it is necessary to follow Good Storage Practices with Standard Modules for pharmacistStore keepers

Proper guidelines on Storage Practices can lead to better Stores and inventory upkeep with medicines being properly stored in racks with proper cleanliness and hygiene

This is a step towards storage maintenance and expiry management at the various stores in the state Looking forward to see that the heads of all health facilities take benefit from this module

D ir e c t o r M e d i c a l S e r v i c e s

30

INDEX

Sr No P a r t i c u l a r s P a g e

1 S T O R A G E A N D S T O C K M A N A G E M E N T 4

1 Quarantine and checking of stocks 11 Quarantine area 12 Checks to be carried out on new stocks

2 S t o r a g e 21 Need for proper storage 22 Different patterns of storage 23 Different means of storage 24 Temperatureclimatic conditions 25 Special storage of supplies 26 Storage and stability of medicines

3 Stock Control and Expiry Monitoring 31 Stock control 32 Stock rotation and expi r y m o n i t o r i n g

4 Other aspects of storage 41 Design of a storage area 42 Cleaning and maintenance 43 Product recalls 44 Returned goods

2 A p p e n d i x 1 Templates of letters for use if found not of Standard Quality [Frozen and expired goods ]

Frozen Drugs-ordered to return to the Suppliers-reg(New drug policy 2009)

Frozen Drugs-ordered to return to the Suppliers- for issue of gate pass after verification reg(New drug policy 2009) Stop instruction-reg(New drug policy

2009) Appendix II Material handling in drug stores

31

3 PROCUREMENT ndash Government Order Relating to

the Management of Stores

(Reproduced for reference material on basic

procedure in decentralized system followed by

Health facilities in 1977)

54

F L O W C H A R T S f o r a BI R D S E Y E V I E W o f

P R O C U R E M E N T

5 5

ACQUISITION OF STORES 6 1

PLACING OF ORDERS 6 2

RECEIPT OF STORES 6 2

CUSTODY 6 3

ISSUE OF STORES Maintenance of Stock Books

6 3

PROCEDURE OF INDENTING FOR WARD amp OTHER SECTIONS OF THE INSTITUTION

6 4

HOW OFTEN TO INDENT 6 5

EMERGENT INDENT 6 5

HOW TO INDENT 6 5

KEEPING OF RECORDS IN WARDS A N D S E C T I O N S

6 6

ACCOUNTABILITY OF DRUGS BROUGHT BY THE PATIENT OR RECEIVED IN DON A T I O N BY T H E WARDSECTION _IN - CHARGE

6 7

RESPONSIBILITY OF STORES AT VARIOUS LEVELS

6 7

DISTRIBUTION OF MEDICINES FROM OUTDOOR DEPARTMENT

6 7

LOSS BREAKAGE DAMAGE ETC 6 8

PROCEDURE FOR WRITING OFF STORES 6 9

DISPOSAL OF WRITTEN OFF ARTICLES 7 1

FORMATS TO BE USED 7 3 - 81

32

STORAGE AND STOCK MANAGEMENT The expiry periods of pharmaceutical products have meaning only if the products are stored under proper conditions otherwise products are likely to lose their potency before the actual date of expiry

A pharmacist is a vital link in the distribution chain for pharmaceutical products The medicinal products remain for a long period during the distribution cycle at the wholesaler and at retail pharmacies It is therefore very important to maintain proper storage conditions in these units

Every community pharmacy however large or s mall needs to store and manage its medicine stocks effectively There must be systems to ensure

middot bullbull Secure storage middot bullbull Clean and correct environmental conditions during storage middot bullbull Accurate and effective record keeping middot bullbull Effective stock rotation and expiry monitoring middot bullbull Effective fire and theft prevention middot bullbull Effective rodent pest control

For easier un derstanding this module has been divided into the following sections

1 Quarantine and checking of stocks 11 Quarantine area 12 Checks to be carried out on new stocks

2 S t o r a g e 21 Need for proper storage 22 Different patterns of storage 23 Different means of storage 24 Temperatureclimatic conditions 25 Special storage of supplies 26 Storage and stability of medicines

3 Stock Control and Expiry Monitoring 31 Stock control 3 2 S t o c k r o t a t i o n a n d e x p i r y m o n i t o r i n g

4 Other aspects of s t o r a g e 41 Design of a storage area 42 Cleaning and maintenance 43 Product recalls 44 Returned goods

33

1 QUARANTINE AND CHECKING OF STOCKS

11 Quarantine Area D r u g S t o r e pharmacies receive stoc k s f r o m su pplie r s a c c or d ing to pur c h a se o r d e r s T he stock that is received must be visually checked for quality and quantity The stocks must be kept in a separate area until the checking is done to avoid intermixing with existing stock This necessitates the presence of a separate area within the pharmacy w h e r e i n t h e storage and other checking of stocks can be performed This area is called the QUARANTINE AREA This area should be marked and identified adequately to distinguish it from other areas

The area may be marked using different means 1 ) A s m a l l board saying Quarantine on a separate table used exclusively if it is in the middle 2) A board on the wall if the table on which the quarantine stock is placed is against the wall

middot Stock received from wholesalers should be immediately transferred t o t h e Quarantine Area

middot In the Quarantine area the stock may be stored on racks shelves or in cupboards to prevent ingress of moisture dirt and other contaminants

middot Regular stocks from the pharmacy should not be left kept in the quarantine area Special care has to be taken in case of refrigerated medicines supplied by the suppliers so tha t the y do not remain in the quarantine area for long periods of time They should be immediately checked on receipt and transferred to areas for refrigerated storage s o a s to maintain the cold chain bull

Advantages of having a separate Quarantine Area middot Avoids cross mixing of newly arrived stock from existing stock till it is checked middot Lays stress on checking the quality of the stock received middot S to ck checking ensures t hat defective andor expired goods do not enter the storage areas

34

bullbull

bullbull

12 Checks to be carried out on new stock

Unpacking and checking stock

Supplies received should be unpacked and checked in the quarantine area Staff doing the checks should be adequatel y trained in what they have to check when stock arrives

Checking should be seen not simply as counting the units received but as a part of the quality assurance system bullThis should include middot Visually inspecting the packaging middot Checking the integrity of containers middot V erifying the completeness and leg ibility of la b e ls ( a ppr o ve d dr u g name strength any special storage instructions and expiry date)

bull

The expiry dat e should be checked to ensure that there is adequate shelf life remaining

Supplies should be individually checked using a checklist 35

Checklists

36

The wholesaler supplying the product should be notified immediately in case of any discrepancies ( and the details should be recorded in a register) and sent in a written format to the supplier It should include middot Missing boxes or cartons middot O p en tampered boxes or cartons middot Missing supplies middot Differences in the actual quantity and the quantity shown on the packing middot Additional medicines that had not been ordered but have been supplied middot D a m a g e d b r o k e n o r p oor quality medicines middot Any other discrepancies

The purchase invoices are an important aspect to be considered The invoiced documents should be signed and filed for reference as per the Drugs and Cosmetics Act and retained for at least 3years

If the wholesaler supplies medicines as an emergency without a bill or against a delivery challan

middot The supplies should be checked for integrity and inspected for damage middot The details of supplies received should be recorded middot The supplier should be asked t o send the bill as early as possible middot When the bill is received it should be checked against the details recorded and anomalies if any should be reported to the supplier

To keep a track of the received stock maintaining a S t o c k R e c o r d C a r d c a n b e very useful The entries in the stock record card can be made while checking the stock received STOCK BIN in the stores should have Stock record card

Maintaining a stock card for every product may not be very practical for a retail pharmacy however it could be maintained for costly medicines Nowadays it is much more practical and easier to maintain records using computers

The pharmacist should ensure that medicines manufacturedmarketed by a company are received only through an authorized distribution network of that company This is important to prevent spurious and counterfeit drugs from entering the pharmacy

37

2 STORAGE 21 The need for proper storage The storage of medicines and other products is an important requirement of Good Pharmacy Pr actice Appropriate storage of medicines is essential -

middot bullTo ensure that the potency is maintained middot bullTo prevent deteriorationspoilagedegradation middot bullTo ensuremaintain physical integrity

To ascertain that the quality and safety is maintained throughout their shelf life Storage requirements need to be considered on 2 aspects

a) Integrity of medicines Medicines should be stored in such a way so as to maintain their integrity and potency middot Maintain the right temperature required middot Protect from excessive humidity middot Keep medicines away from direct sunlight middot Protect from pests and rodents

b) Physical location middot Should be easy to locate middot Accessible middot Orderlysystematically placed

2 2 D i f f e r e n t p a t t e r n s o f s t o r a g e The pharmacist could follow any of the different patterns of storage The pattern of stora ge should be selected in such a way that it facilitates speedy and efficient dispensing of medicines

The pattern of storage could vary with each pharmacy experience usual practiceroutine of staff and the person-in charge and also depending on space av ailable turnover etc (i) The medicines could be stored c o m p a n y w i s e ie the medicines manufactured by one company should be grouped together and kept in one place Within each company shelfshelves the medicines may be placed in alphabetical order for easy and quick placement and removal Also bottles tubes boxes etc may be segregated within that shelf

38

(ii) The medicines may also be stored in a lphabe t ic al o r de r ie they are placed in order from left to right based on their name The first letter of the name is used to g r o u p t h e m e d i c i n e s t o g e t h e r a n d k e e p t h e m i n o n e l o c a t i o n I n s o m e p h a r m a c i e s a l l t h e strip packing are placed in drawers or boxes in alphabetical order each box or drawer containing strips of one particular alphabet This system ensures that the strips always remain e n c l o s e d i n t h e b o x e s d r a w e r s a n d a r e n o t e x p o s e d t o d u s t T h e d i s a d v a n t a g e i s that it might lead to mix -u p o f strips in the same drawer and it may cause a problem incase of similar looking strips in which case a wrong medicine may be dispensed Secondly cut strips lying around in the drawer may lose their identity if the batch n u m b e r andor expiry date is not seen on the cut portion of the strip

39

(iii) The medicines may be stored according to their therapeutic class ( e g a n t i b i o t i c s anti asthmatics or anti hypertensives) ie the medicines are kept together based on their pharmacological or therapeutic action

(iv) The medicines may be stockedsegregated according to dosage forms eg l i q u i d s (bottles) solid oral dosage forms eye drops rotacaps ointments etc all stored on separate shelves

Always Remember I Storage of prescription medicines should preferably be separate from OTC medicines OTC medicines especially those that a r e a d v e r t i s e d m a y b e d i s p l a y e d f o r c l i e n t s t o select or to ask questions about [OTC-O v e r t h e c o u n t e r ] II Storage according to temperatures is a must no matter which pattern of storage is followed Also within a particular storage area segregated storage may be maintained In a refrigerator for example medicines may be stored in trays racks and the freezer according to the temperature required

40

Whatever pattern of storage is selected all the personnel should ensure that middot The stocks are stored in an orderly manner middot The medicines are kept back in the same place from where they were removed middot All medicines are arranged neatly once in a while

middot The personnel should be careful while storing the medicines middot They should not throw the medicines haphazardly 23 Different means of storage

middot Within each temperature and security zone medicines must be stored so that they are easily accessible and protected against damage

middot Basic means of storage include shelves racks and drawers middot To prevent dust from entering the shelvesracks it is ideal to have glass

shutterssliding glass doors This can however be disadvantageous because accessibilityspeed is hampered in removing a product from the shelf because the glassshuttersliding glass has to be

41

opened m o v e d e v e r y t i m e a p r o d u c t h a s t o b e p i c k e d u p U s e o f a i r c o n d i t i o n e r s f o r t h e p h arm acy with a closed door at the e n t r a n c e o r a n a i r c u r t a i n c a n r e d u c e t h e d u s t problem In such cases the shelvesracks may be left o p e n

bull

middot Direct storage of cartons on the floor should be avoided because besides being an unhealthy practice the contents may also be damaged by moisture bull

middot Store medicines preferably in shelves with glass shutters for visibility middot Closed shelves further prevent dust from going in especially in India where most

pharmacies are located along busy roads middot Some medicines have to be refrigerated or stored in a cool or cold place Having a

refrigerator or two (as per the need of the pharmacy) is essential to store suc h medicines at temperatures mentioned on the label bull

42

Refrigeration middot All cold chain equipment should meet required standards middot Improvement in refrigeration technology has provided frost -free refrigerators

Pharmacists should opt for frost-free refrigerators as they are easy to maintain and protect printed packaging materials Conventional refrigerators may cause water falling from trays below the freezer on medicines stored in the refrigerator thus causing soggy labels

middot bull Frost-free refrigerators also provide separate and large compartments for the freezer portion (required for storing medicines needing sub-z e r o t e m p e r a t u r e ) and the main storage area with separate doors so that opening one door does not disturb the storage temperature in the other compartment

Care should be taken to keep the refrigerator on 24 hours a day It should not be switched off after working hours It is advisable to have an inverter connected to the refrigerator so that the refrigerator re mains working even when there is a power outage

middot The refrigerator door should be closed tightly middot The refrigerator door should not be left open for too long middot Space should be left between medicines stored in a refrigerator to allow air to

circulate middot The ref rigerator should be placed about an arms length away from the wall

This will increase air circulation thus not affecting the cooling within the refrigerator

middot Vaccines should not be stored on refrigerator door shelves as they are exposed to warmer temperatures each time the door is opened Vaccines should always be stored on the middle shelves of the refrigerator

middot Refrigerated medicines should not be left out of the refrigerator for more than a few minutes

43

middot Consumable products like juices energy drinks e t c s h o u l d n o t b e s t o r e d a l o n g with medicines in refrigerators If required they may be kept in a separate refrigerator

middot An adequate number of refrigerators should be planned to store the entire stocks requiring refrigerated storage

middot Adequate procedures should be followed for defrosting cleaning and maintenance of refrigerators

middot Icefreeze packs should be kept in the freezer compartment so that they can be used for transporting cold temperature medicines The packs can be given to clients along with the medicines requiring cold temperature storage so that the temperature is maintained till the client reaches home and can then put the medicines in a refrigerator) Freezer packs can also be used to keep medicines temporarily in case there is a power outage or refrigerator breakdown

Activity

Prepare a SOP (Standard operating procedure chart) for cleaning a refrigerator Discuss it with your staff finalize its maintenance once a month through AMC -A n n u a l Maintenance contract CMC - Comprehensive maintenance contract and put it up on the pharmacy refrigerator Put the Purchase Order details name of manufacturer Phone of Service Engineer and a register to login the Machine service and down timeService reports may be maintained properly

Refrigerator monitoring and maintenance

middot bullIt is important to carry out routine monitoring and maintenance of the refrigerators and to organize an effective repair system

middot bullThe temperature in the refrigerator must be monitored and recorded routinely at least once a day

middot Any breakdown must be reco rded including the period during which the medicines were exposed to uncontrolled temperatures Medicines may then be kept or discarded depending on the problem guidelines or the manufacturers advice

middot Cold chain monitor cards and devices in or on packages that change color or otherwise alert staff to potential damage assist in monitoring (These are likely to be introduced in India soon)

middot It is essential to have a contingency plan in place before a refrigerator breaks down An arrangement can be made to move the contents to a private refrigerator elsewhere in the community or to obtain a regular supply of ice packs until the defect is rectified

Put filled water bottles in the bottom half of the refrigerator door in order to provide cooling in the refri g e r a t o r w h e n t h e r e i s a p o w e r o u t a g e T h i s m i g h t t a k e c a r e o f t h e temperature when there is no current for a couple of hours If the power outage is expected to last for several hours special arrangements such as an inverter UPS have to be made to keep the refrigerator constantly running in the absence of electricity middot Defrost the refrigerator in case of excessive ice formation and preferably at regular

intervals Keep a record of the same

44

2 4 T e m p e r a t u r e c l i m a t i c c o n d i t i o n s

i) Temperature control middot The medicines in a pharmacy need to be stored at appropriate temperatures to

maintain their stability middot An air-conditioned environment where temperature can be controlled is

recommended for pharmacies Air conditioning offers the option of setting the t e m p e rature as per requirements

middot bullIt is ideal to have an air conditioner to maintain the temperature below 25 C as most medicines require storage below this temperature Secondly this temperature is pleasing to both the staff and the visiting customers too

middot In the absence of an air conditioner circulating fans may be used middot This need is felt even more in certain parts of India where temperatures soar above 45

C and some areas where it falls to sub zero temperatures In such cases temperature maintenance is essential to prevent deterioration of medicines due to unnecessary exposure to drastic temperature fluctuations

middot This need is felt even more in certain parts of India where temperatures soar above 45 C and some areas where it falls to sub zero temperat u r e s I n s u c h c a s e s temperature maintenance is essential to prevent deterioration of medicines due to unnecessary exposure to drastic temperature fluctuations

i i ) Humidity or moisture control Moisture or humidity can adversely affect the stability of me dicines such as tablets capsules powders

45

Gelatin capsules become soft and swell on absorption of moisture The drug content of tablets may undergo surface hydrolysis The presence of moisture may encourage the growth of microbes It is therefore essential to control humidity

To reduce the effect of humidity the following suggestions may be followed -middot Open the windows to allow air circulation Use a fan to circulate fresh (outside) air middot In humid climate a dehumidifier is useful for preventing mo i s t u r e d a m a g e ( i n t h e absence of an air conditioner) middot For bulk containers of tabletscapsules do not keep the container open for a long time and replace the lid or closure immediately after taking out the required number of medicines for dispensing middot Do not allow the medicines to touch the floor or the walls The walls may be damp and may cause moisture absorption damaging the product

middot Calibrated thermometers and manometers can be used to detect temperature and humidity in the pharmacy

middot Periodici t y of checking the temperature should be fixed middot The climatic conditions should be recorded and documented middot Temperature charts should be available for ready reference

Documentation is one of the core activities for achieving and maintaining quality It is one of the most essential components of validation Temperatures in various areas

46

including refrigerators should be recorded at a predetermined periodicity usually daily at the hottest time of the day and such documents should be preserved i i i ) Storage conditions A number of storage conditions are mentioned on the labels of medicinal products These conditions have to be properly interpreted and appropriately complied with

According to the Drugs and Cosmetics Rules 1945

1 The term cool place means a place having a temperature between 10 C and 25 C

2 The term cold place means a place having a temperature not exceeding 8 C In case of storage conditions for specific products please refer to Schedule P The Drugs and Cosmetic Rules 1 9 4 5

The Indian Pharmacopoeia specifies the following storage conditions -

Wherever the condition for storage is not specified medicines may be stored under normal temperature In a country like India however where normal temperatures soar to h i gh temperatures it is recommended that medicines be stored in a cool place

Activity Prepare a list of the storage requirements mentioned on the label of about 20 products in your pharmacy and check if the temperature is maintained

47

25 Special Storage o f s u p p l i e s If the product has no special instructions normal storage conditions apply This means storage in dry clean w e l l -ventilated premises at temperatures of +15 C to +25 C or depending on the climate up to +30 C (WHO1990) Storage instructions are product specific Different brands of the same generic drug may have different storage requirements as they may have different packaging or formulations It is essential to follow the product manufacturers storage instructions to the maximum extent possible Less stable medicines must be stored in specific conditions to maintain their quality or potency

The following products require special storage facilities

middot Products that must be kept frozen (usually vaccines and sera) middot Products sensitive to h eat an d r e q uir in g r e f r ig e r a tio n ( +2 C to +8 C) middot Products that have reduced shelf life at uncontrolled room temperature and need

mechanical ventilation or air conditioning middot Flammable products that require separate fireproof premises middot Products prone to theft o r m i s u s e

Products needing storage in a controlled environment -

The usable shelf life of the following products may be reduced if stored at uncontrolled humidity or at room temperature in hot climates -

middot Some injectables (eg adrenaline) Most injectable preparations are less stable than solid oral forms (tablets and capsules) Injectable preparations in solution are particularly unstable Many injections must be protected from light as well as heat

middot Intravenous fluids (particularly if packed in p lastic containers) middot Some suppositories pessaries creams and ointments These products may melt at

temperatures greater than 30 C Once this happens it is not advisable to use them because the active ingredient in the formula may get unevenly distributed

middot Products containing rubber latex cellulose or some plastics Condoms most sterile disposable medical devices and surgical products such as syringes needles and catheters require protection from excessive humidity and strong light and heat Any o f these conditions may make products brittle stained amp unusable Sterility cannot be assumed if packaging is damaged

In hot climates these products should be stored in the coolest place possible preferably with air conditioning or air circulation fans

48

Products needing freezing or refrigeration-middot Vaccines blood products and many other medicines lose potency if kept even for a

brief period at temperatures outside the recommended range For these products the cold chain must be maintained at every stage of the distribution system

middot Freezing is as damaging as high temperatures for some products including injectable contraceptives ergometrine insulin adrenaline and the DPT DT TT and Hepatitis B vaccines Such products therefore sho uld not be allowed to freeze (not be kept in the freezer compartment)

middot Short periods at room temperature (during transportation or local distribution for instance) may be acceptable for many products (such as ergometrine a n d i n s u l i n ) e v e n t h o u g h s u c h e x posure can to some extent reduce shelf life Other items such as vaccines should always be transported in cold boxes

Storage of insulin injections-

middot Insulin should always be stored in a refrigerator at the recommended temperature of 2 -8 C

middot Insulin should not be kept in the freezer compartment of the refrigerator middot Insulin should ideally be stored horizontally middot It should not be exposed to sunlight or excessive heat middot Insulin suspensions should not be used if the suspension cannot be properly

resuspended due to cake or clump formationbull

Controlled drugs -Narcotics (for example Pethidine injection morphine preparations) and other specified drugs that may be abused are governed by special legislation and regulations The following security measures are suggested in the pharmacy -middot A safe or reinforced double locked cabinet fitted with a light (preferably with a red

bulb) that comes on when the door is opened

49

middot A special register recording details of each receipt or issue with 2 signatures physi cal counting of medicines after each entry and signatures at handover takeover

middot Independent audit (by supervisors and drug inspectors)

Products prone to theft abuse or misuse -

Some medicinesproducts are particularly prone to theft abuse or misuse These include expensive medicines (eg insulin) certain antibiotics and products prone to abuse or misuse like psychotropics etc

Such medicinesproducts should be stored adequately They require stricter record keeping and more frequent stock taki ng than others Periodic audits should be carried out to check for consumption against actual recorded use (registers prescription records stock records etc) to expose any theft or misuse bull26 Storage and stability of medicines Medicines are not stab le indefinitely They are stable for a specific period of time sometimes for a brief period Poor storage conditions accelerate the drug degradation (decomposition) Temperature light and moisture are the most important contributing factors for drug instability It is important to identify and be aware of the potential for instability There is a need to comply with storage requirements to ensure quality medicines for patients It is also important to offer advice to patients too about appropriate storage o f medicines at home The dispensing label should state the storage condition required and be backed up by a verbal reminder especially where special storage is required bull

50

In case stability and storage problems are seen with formulations they should be reported immediately to the representative of the manufacturer and taken out of circulation till the stability problems have been resolved

The pharmacist can easily detect stability problems when products show change in appearance color odor settling of the product contents breaking of emulsions melting of creams oozing of contents from the containers and any such physical changes

3 STOCK CONTROL AND EXPIRY MONITORING 3 1 S t o c k C o n t r o l For economic reasons pharmacists do not like to have stock on their shelves for long periods of time The aim should always be to keep stock at a level that will just meet demand Normally most manufactured medicines have a long shelf life Even then it is essential that there is efficient stock rot ation so that the older stock is used first It is also a good practice to check the expiry date as an integral part of the dispensing process When short shelf life products are involved stock levels may have to be modified to prevent medicines regularl y expiring on the shelves

32 Stock rotation and expiry monitoring In order to avoid accumulation of expired and obsolete stock medicines should be stored and issued according to the following guidelines -middot The stock control system must record the ex p i r y d a t e a n d t h e d a t e o f r e c e i p t middot Stock must be stored so that earliest expiring batches are picked and issued first middot The First In First Out (FIFO) system - In this system the stock which is received

first is sold first This system however may not be useful for pharmacies because most of the stocks carry an expiry date For pharmacies the FEFO system is more practical

51

middot The First Expiry First Out (FEFO) system - In this system the stock having an earlier expiry is sold first The stock with longer shelf life should be placed farthest to the back (or at the bottom in case o f sta c k e d b oxe s) T h is is pa r tic u la r ly impor ta n t with products that have short shelf lives such as vaccines some vitamins antibiotics etc and reduces losses due to expiry

middot E x p i r y dates should be noted on the stock record upon receipt Stock nearing expiry should not be accepted unless it can be used before expiry

Computerization and expiry monitoring In the pharmacy computerization facilitates both checking stocks and expiry mo nitoring and helps-bullbullKeeping a check on products nearing expiry bullbullKeeping a check on non- moving and slow moving products bullbullTo facilitate the removal of medicines nearing expiry from shelves in time to send them back to the wholesaler or supplier

Periodic checking for expiry The expiry date for medicinal products is a critical aspect in pharmaceutical dispensing and due importance should be given to it Periodic checking for expiry of medicines will ensure that the patient will never receive products that have crossed their expiry date During periodical checking of expiry the personnel involved should remove medicines that are nearing expiry bullbullIn -house threshold periods should be set and followed for retrieval of such medicines from the shelves bullbullSuch medicines should be stored separately These should either be dispensed immediately (thus ensuring that they are used before the expiry date) o r t h e y s h o u l d b e returned to the suppliers bullbullA separate area should be designated (cupboard or shelf)marked[FROZEN ZONE] which is adequately marked EXPIRED GOODS- NOT FOR SALE to store all expired stocks FROZEN ZONE

52

Remember Expired medicines are a NATIONAL WASTE So stock only what you can sell Avoid expiries save precious medicines for the nation

Treatment and disposing of expired medicines bullbullProcedures need to be in place for the treatment of expired medicines bullbullThe expired medicines need to be collected and be sent back to the supplier or company for appropriate disposal bullbullRecords must be maintained for expired medicines and how they are disposed off bullbullIn case of medicines that are not returnable to suppliers procedures for disposal need to be followed by the pharmacy in conjunction with the FDA The following procedure can be followed if medicines cannot be returned to suppliers ( T h e b a s i c p h i l o s o p h y of appropriate disposal is to prevent their re- circulation and use) bullbullC u t t h e c o n t ainer in such a manner that the label is also cut In case of tablets and c a p s u l e s d e s t r o y them by disposing them in a bucket of water bullbullUse landfill procedures (deep burial into the ground as per stipulations of Medical Waste Disposal Act prevalent in the respective state) bullbullPour the liquids into the sink and wash away with sufficient quantity of water bullbullKeep a record of such disposal with full details of medicines destroyed Although these measures are usually adopted care has to be taken with such tr e a t m e n t a s studies have shown that flushing of medicines has resulted in tracessmall quantities of medicines being found in waterways and groundwater having potential health and environmental effects

4 O T H E R A S P E C T S 41 Design of storage areas The following important factors need to be considered in design of storage areas -middot The retail outlets in hot areas in summers should be air-conditioned Similarly in

a r e a s o f e x t r e m e c o l d t h e p r e m i s e s w o u l d r e q u i r e w a r m i n g e s p e c i a l l y i n w i n t e r s t o maintain cool temperatures The placement of air -conditioners and heating devices should be such that medicines are not directly exposed to the cold or heat

middot Due consideration should be given to storage requirements of formulations while designing shelves and cupboards in retail outlets Sufficient shelf height should be provided so that all liquid products can be stored vertically As far as possible the shelves should be covered with glass panels to protect medicines from dust and p r e v e n t r a p i d f l u c t u a t i o n s i n temperature

middot Medicines should be stored according to the storage instructions on the labels bullIt is ideal to have a door at the pharmacy entrance to prevent dust from coming in as well as reduceprevent cooled air from going out This may not however be considered feasiblepracticable by many pharmacy owners for fear that clients may not enter the pharmacy because the door may act as a barrier An air curtain is a good alternative to a door

middot There should be minimal direct sunlight falling on the products Particular consideration should be given to premises directly facing the sun

middot bullThe arrangement of lighting in the interior of the premises should also be in a manner that the lights are not focused on the products It has been shown that light causes not only chemical damage but also can catalyze physical changes like moisture uptak e by the products Care should be taken to ensure that only diffused light falls on them

53

middot As far as possible provision should be made for a temperature and humidity indicator device in a pharmacy These devices are now easily available

middot Stability studies o f m e d i c i n e s p a c k e d i n b l i s t e r s h a v e r e v e a l e d t h a t i f t h e s e a r e exposed to light they tend to absorb moisture It is therefore necessary to store them in suitable cartons so that the blisters are not exposed to light Pharmacists should do this even if the manufacturer has not provided cartons

middot Light and temperature sensitive products should not be stored on counters where the light is intense or direct and there is no protection from temperature and humidity

42 Cleaning and maintenance i) Cleaning of storage areas

The storage areas of the pharmacy should be cleaned periodically and cleanliness should be maintained at all times The Standard Operating Procedure for cleaning should be designed and followed accordingly Schedules for cleanups should be laid down and adequate cleaning equipment should be made available

Tips for maintaining cleanliness middot Provide clean pieces of cloth for wiping at various locations in the pharmacy

Replace with clean cloth at regular intervals middot Keep separate pieces of cloth for floors shelves and medicines middot Use a disinfectant andor soap solution to clean floors middot Ensure removal of dust and prevent accumulation of dirt middot Ensure removal of cobwebs middot Use a vacuum cleaner for cleaning areas not easily reachable middot T a k e c a r e t h at breakages are handled and cleared effectively middot Observe the factors leading to waste generation in the pharmacy and take appropriate

measures to tackle the problem middot Record all cleaning procedures performed and maintain all the documents required

For ex a m p l e -bullbullThe floor of the pharmacy may be swept with a broom and swabbed with soap water every morning bullbullThe floor may be swabbed with a disinfectant every week bullbullThe entire premises including shelves and cupboards may be cleaned with a cloth (to remove dust and to check for medicines approaching expiry date or expired medicines) every three months bullbullAll the steps followed should be r e c o r d e d

The floor shelves drawers have to be cleaned and a check should be kept on dust cobwebs spillages due to breakage etc It is therefore essential to have SOPs for cleaning laying down cleaning frequencies allotting responsibilities and maintaining a daily record in the logbook to document all these activities

54

While cleaning dust settled on dosage forms like bottles tubes etc should be removed Before dispensing the products should also be wiped to remove any dust settled during storage

For refrigerators bullbullDefrosting and cleaning should be done at regular intervals bullbullSwitch off the refrigerator while cleaning bullbullCleaning should be done quickly and stocks put back immediately

i i ) Pest control Pests are a serious problem in India where insects reptiles and rodents (eg cockroaches l i z a r d s r a t s s i l v e r f i s h (Deemak - in Hindi ) etc) may find access to the pharmacy storage areas Insects like ants and borer ants may often attack wood in the pharmacy causing d am ag e to shelves cupboardsPest c ontr o l in a p h a r m a c y c a n b e a d i f f i c u l t t a s k b u t t o avoid possible contamination and physical damage to stock it is necessary to keep pests out of the pharmacy premisesPest control measures should be implemented with proper p r e c a u t i o n s t a k i n g u t m o s t c a r e t o a v o i d contamination of medicines

55

Th e following pest control measures c a n be ta ke n f r om tim e to tim e -bullbullRat bait and traps can be placed at various locations bullbullInsecticutors can be used on a permanent basis bullbullInsecticidal sprays and repellants can be used from time to time

i i i ) Fire precautions

Combustible trash such as cartons boxes and other packing waste must not be allowed to accumulate in the store Waste should be deposited in appropriate waste bins and be d i s p o s e d o f f o n a d a i l y b a s i s

F i re detection and fire fighting equipment must be maintained and regularly inspected The pharmacy personnel should receive adequate training in fire fighting techniques and emergency actionFire prevention measures should include a prominently displayed ldquoNoSmokingrdquo sign careful handling and disposal of combustible waste materials and checking of electrical connections at regular intervals

iv) Security middot Doors shutters of the pharmacy should be strong and be fitted with secure locks middot Counters should be designed so that unauthorized personnelclients do not have

access to areas where prescription medicines are stored Access to such areas should be restricted to the pharmacy staff

middot All the pharmacy staff handling supplies should be accountable for their ac t i o n s

56

middot bullSpecial care must be taken in case of Schedule X and manufactured drugs (under NDPS Act) Such medicines should be kept under lock and key and the key should be kept with the Chief Pharmacist or i n h i s a b s e n c e t h e s e n i o r p h a r m a c i s t

v) Breakagespillage and damaged product Products that have been damagedspoiled during storage and handling spillages and broken glassware should be disposed off according to procedures laid down by the pharmacy Broken and damaged products s h o u l d b e p l a c e d i n a segregated area to be returned to the supplier

vi) Inspection Senior staff should inspect all pharmacy areas regularly The shelves and drawers should b e c h e c k e d d a i l y f o r signs of pests and dust Ceiling and walls should be checked for dirt and cobwebs Stock should be checked on a regular basis for deterioration due to climatic conditions

43 Product recalls Products found to be defective should be quickly recalled (withdrawn from the market) The instructions are generally issued either by the manufacturer or the regulatory agency The level of recall is determined by both the degree of risk and the extent of distribution of the product and in India is mainly directed at the distribution chain

On receiving the details of the defective substandard spurious batchbatches of a medicine to be recalled from the manufacturer or the stockist or the FDA the pharmacy should immediately check if the particular b a t c h i s i n s t o c k a n d i f s o s u s p e n d i t s s a l e immediately

Similarly if the regulatory authority in the country bans a particular medicine or FDC the pharmacy should immediately check and remove all the different brands of that particular medicine under consideration

The details of medicines and their batches to be recalled should be available in the q u a r a n t i n e a r e a w h e r e stocks are received and checked This is to ensure that such medicines do not come into the pharmacy

middot The pharmacy should develop SOPs for recall of medicines middot The pharmacy staff should be immediately informed about such medicines and

the details should be displayed in writing in a prominent place in the pharmacy middot Rapid action helps avoid unnecessary exposure to such medicines once the

problem has been d e t e c t e d middot The progress of the recall procedure in the pharmacy should be monitored every

few days to ensure complete compliance middot All stocks of the recalled products should be stored separately from the saleable

stock These can be stored in the expiry cupboard segregated from the expired goods and be appropriately labeled ldquoRecal l e d G o o d s - Not for Salerdquo

The supplier should be notified and asked to replace defective products middot All the details of the procedures followed should be duly recorded in a Recall

Register maintained specially for the purpose The register should include d etails such as -middot Date of the recall middot Nam e of the product

57

bullbull

middot Details of the product (name of manufacturer batch number expiry date) middot Nu m b er of units purchased sold a n d sto c k in ha nd middot Reason for recall middot Nam e of the supplier to whom produc ts w e r e returned along with the date and quantity middot Name and signature of the designated personnel carrying out the recall procedure and recording details middot Name and signature of the chief pharmacist verifying the recall procedures and recording details 4 4 Returned medicines

Medicines may be returned to the pharmacy by clients due to the following reasons -bull

bullbull Unused medicines bullbull Course not completed bullbull Therapy changed by doctor bullbull Side effects experienced by patient bull

bullbull DamagedDefective medicines bullbull Missing or defaced label bullbull Missing tablets in a stripblister bullbull Leakage in bottles bullbull Leakage in strips bull

bullbull Expired medicines

Appropriate SOPs should be framed and followed for their acceptancerefusal and disposal middot bull For unused medicines returned by clients the p harmacy personnel should verify

that these were purchased from their pharmacy They should then be checked for integrity of the packing the dosage form and the expiry date and verified with the client whether they were stored in appropriate conditions This again is at the discretion of each pharmacy

middot The damageddefective medicines returned to the pharmacy should be taken back and stored separately Existing stock of the same product should be checked for similar defects

middot Expired medicines should be accepted from clients at the discretion of the pharmacist and be immediately shifted to the expired goods cupboard These can be stored segregated from the pharmacys own expired goods and be appropriately labelled ldquoExpired Goods returned by clients- Not For Salerdquo

It is advisable not to accept returned medicines requiring cold chain storage (refrigeration) because it cannot be ensured that the cold chain was maintained when the medicines were in the hands of the patientclient middot Appropriate adjustments in t he stocks should be made for medicines

returnedexchanged to update the inventory middot The medicines should then be returned to the respective shelves middot A lsquoReturned Goodsrsquo register needs to be maintained to record all details of returned

medicines

R egister should include such details as-

58

middot N a m e o f t h e p a t i e n t middot Nam e of the product and quantity r e tu r n e d middot Product details such as the batch number and expiry date middot Condition in which received middot Reason for returning products middot Compensatory measures taken wi t h r e s p e c t t o c l i e n t middot Action taken with respect to product middot Name and signature of the personnel accepting the returned medicines and recording details middot Name and signature of the chief pharmacist verifying the recorded details

What the pharmacist would have learnt from this module The storage of medicines is a critical factor in the distribution cycle bullbull Stocks received by the pharmacy should be quarantined in a separate area and necessary checks s h o u ld be performed to ascertain the qua lity a nd quantity of stocks received bullbull Whatever pattern and means of storage used the products should be stored so as to maintain their potency and integrity bullbull Storage conditions should be monitored and maintained on a regular basis bullbull Optimum stock levels should be maintained and regularly monitored for expiry bullbull The design of storage areas should facilitate appropriate storage of medicines bullbull Cleanliness should be maintained in the pharmacy bullbull Adequate measures should be taken in case of returned medicines and recalled products

Optimum storage of medicines is mandatory whether at the distribution stage at the pharmacy or ultimately within the homes of patients The pharmacist has an important r o l e t o p l a y i n t h e s t o r a g e o f m e d i c i n e s i n m a i n t a i n i n g d r u g p o t ency and efficacy and thus facilitating optimum therapeutic benefits Good Pharmacy Practice - IPA -CDSCO - WHO Appendix I Quality Assurance Templates of letters for use if found not of Standard Quality [Frozen and expired goods ]

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated To Name of the Supplier with address

Sub Not of Standard Quality GoMP-Supply of Drugs and medicines-(Codename) Return of Stocks to the Suppliers-reg(New drug policy 2009) Previous letterinvoice ref Sl No Drug Code Drug name

Manufacturing date Expiry date

Supplier address

B a t c h n o

The above items of PO nodated was drawn by the Drug Inspector (Place) on (______________date) as a statutory sampling and declared ldquoNot of Standard

59

Qualityrdquo on -(______________date) by the Government Analyst for the following reasons

- ldquoThe product sample do not confirm to IP specification for (Drug codename with respect to the content of drugrdquo

- ldquoThe product has already been blacklisted by TNMSC on -(______________date) for the failure of (quantity) of batches of drug codenamerdquo

As per the clause of the te nde r d oc um e nt ldquo I f the sa mple s d o not c onf o r m to statutory standardsthe tenderer will be liable for relevant action under the existing laws and the entire stock in such batch should be taken back by the tenderer within a period of 30 days o f t h e r e c e i p t o f t h e l e t t e r f r o m t h e v e n u e

The stock shall be taken back at the expenses of the tendererthe Procurement Authority have the right to destroy such Not of Standard Quality if the tenderer does not take back the goods within the stipulated time

The Procuring Authority will arrange to destroy the Not of Standard Quality drugs within 90 days after the expiry of 30 days mentioned above without further notice and shall also collect demurrage charges calculated at the rate of 2 per week on the value of the drugs rejected till such destructionrdquo

Hence we regret to inform you that you will have to take back the stocks available of the abovesaid batch at your own cost from the drug stores where you have supplied the above batch

Kindly acknowledge the receipt of this reference at once

P r o c u r e m e n t A u t h o r i t y Seal and Stamp

Copy to Ref No dated

1 ) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated13082010

To

Sub Frozen Drugs-ordered to return to the Suppliers-reg(New drug policy 2009) Previous letterinvoice ref

The following products which were earlier frozen have now been ordered to return to suppliers directly with permission from the State drug Authority In this regard the suppliers have been instructed to take back their failed batch from the drug store of the stores Hence you are now instructed to return the following failed batches to the suppliers by obtaining proper authorization letter and acknowledgements from them

60

Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

Kindly acknowledge the receipt of this reference at once

Procurement Authority Seal and Stamp

Copy to

Ref No dated 2) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated14092010

To

Sub Frozen Drugs-ordered to return to the Suppliers- for issue of gate pass after verification reg(New drug policy 2009) Previous letterinvoice ref

The following products which were earlier frozen have now been released Hence they may be issued Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

Kindly acknowledge the receipt of this reference at once

Procurement Authority Seal and Stamp

Copy to

61

Ref No dated 3) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated

To

Sub Stop instruction-reg(New drug policy 2009) Previous letterinvoice ref

Until further instructions stop issue all the batches of the following item Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

You must intimate the available stock in the stores of the said batch Number to the Procurement Authority immediately Also retrieve quantity if already issued

Procurement Authority Seal and Stamp

Copy to

Ref No dated 4) HOD Procurement Office of

62

Appendix II Material handling in drug stores

Rack approx rates and dimensions

S No

Item Description UOM Approx Rate

1 MEDIUM DUTY RACK SIZE 2900 H X 3090 W X 800 D IN MM (AS PER SPECIFICATION)

Each 2499800

2 MEDIUM DUTY RACK ADD ON UNIT FOR SIZE OF SR NO2

Each 2243100

To locate a Box no 3 Rack no 14 in row3

SAMPLE OF RACK no Bin numbering -------------- S a y R K 1 4 R o w 3 B o x 1 6

SAMPLE LAYOUT of RACKS in a Drug Stores

63

Sample of another warehouse of distribution warehouse system

64

65

Slotted Angle racks with bin cards

66

Plastic Pallets

Plastic pallets ar e l i g h t w e i g h t l o w- c ost and exceed industry standards for strength and durability

NOTE A pallet has bottom deckboards (see sketch) A skid does not have bottom

67

deckboards

Battery Operated Stacker

Electric Stacker Ehh (Manual Push Type) - Manual drive - Lifting electrically with Battery 12 V 88 Ah - For loading and un-loading of trucks - Battery and loading device built - in - Battery charge gauge and charging current gauge Simple and Easy Operation - Lifting and Lowering electrically direct on steering arm - Pulling and pushing through steering arm - Electrically operated relief valve on hydraulic aggregate Safe Operation - Emergency Off Switch - Constant lowering speed - Protection through lowering brake valve - Overload protection through overload brake valve - Load chains covered preventing pinching threat - Electrically interlocking during loading process - Secured battery compartment opens upwardly - Stable buffering of the steering arm in upright position - In accordance with EWG Guidelines 89 240 - In accordance with VBG 12b Prevention of Accidents

Pallet Truck [ Top ]

68

----------------------------------------------------------------------------------------------------------------------------

For Transport Of All Goods On Pallets Safe and Easy Operation - through single hand operation Lifting moving

lowering with steering handle - neutral position of the hydraulic possible - overload pressure relief valve Long Service Life - robust co n s t r u c t i o n

- special hardened axles - hardened chromium plated ram - maintenance free Easy Maneuverability - through rubber steering rollers - nylon fork rollers

A h a n d t r o l l e y

69

Trolley with plastic bins for several items del ivery

70

Digital Weighing balances

Balances amp Scales EF Seriers Precision Electronic Balance

71

1

Ice lined Refrigerators

600 litres refrigrator

72

Walk in cooler

vacuum cleaner

73

These reports have to be signed by the investigating officer and are to be then submitted to competent authority for suitable action One copy which is returned is to be kept with the Stock Register In cases where the b r e a k a g e o r d a m a g e i s o f s u c h b i g g e r d e g r e e t h a t s atis factory repairs are not possible a n d if suc h b r e a k a ge o r da m a ge is o f su c h a de gr e e that satisfactory repairs are not possible and if such breakage or damage has been caused-

( i ) B y a G o v t s e r v a n t because of negligent or careless handling cost of the article should be recovered from him and credited to the treasury (ii)On account of reasons mentioned above that is un predictable action of the patient accidental or manufacturing defectthe article could be written offsubject to powers delegated to the concerned for such purpose

(C )Shortages detected during biannual physical verification of the Storeshave to be dealt in a similar manner

(D) it shall be at discretion of the competent authori ty (who is empowered to write off the loss) to reduce the amount of recovery upto 50 of the cost of article provided that before arriving at such a decisionhe has taken into account the following points (a) Normal life span of the article under questi on (b) Period for which it has been in use (c ) Condition of the article at the time of loss or damage and (d) Whether it was on account of careless or negligent act or not

XVI PROCEDURE FOR WRITING OFF STORES

(a) When any Stores become unserviceable otherwise than in ordinary course or by fair wear and tear their value should be treated as loss to the Government and in such cases cost should be recovered from the person responsible for his negligence

( b ) A s t r i c t w a t c h s h o u l d b e k e p t o n t h e m e d i c i n e s w h i ch bear an expiry date and if there is no likelihood of their being utilized locally intimation of the fact should be sent to Directorate of Health services and also to all o t h e r d i s t r i c t s s i m u l t a n e o u s l y s o t h a t t h e y c a n b e p u t t o u s e b e f o r e t h e expiry date In the event such a course is not followed and the Government i s p u t t o l o s s c o s t o f t h e m e d i c i n e i n q u e s t i o n s h a l l b e r e c o v e r e d f r o m t e defaulter

(c) For declaring articles as unserviceable a Committee of three members should be formed in each officeinstitution This Committee should examine each and every article brought before it and should record full reasons for condemning them and also say how the articles condemned have to be disposed of-whether by sale (by public auction) or otherwise

I f t he local Authority is not competent to write off the articles condemned by the Committee it should send the proposal to the higher authority for suitable a c t i o n

17

In Institutions where there is only one doctor a list of articles to be condemned should be p r e p a r e d a n d o r d e r s o n i t b e o b t a i n e d f r o m t h e inspecting authority during inspection

While preparing any list of articles for condemnation details regarding the date of purchase date of receipt period during which it remained in use usual life of the article and its purchase price should be noted against each item

( d ) The condemned articles should not be struck off the Stock Register till the competent authority sanctions its write ndashoff Details of Authority under which the article has been written off should be mentioned in stock register

XVII DISPOSAL OF WRITTEN OFF ARTICLES

Articles like linen should be torn into strips 10cm width so that they could be burnt or given to Government Jails for making carpets

Items like bed -pans bowlsurine po ts etc should be crushed and kept for auction

Brass utensils have also to be crushed to destroy their shape and could be either auctioned or after inviting rates from several dealers could be locally sold to highest bidder

In case when condemned ar ticles have to be sold by public auction they should be stored safely and the Government Auctioneer be intimated In case he expresses his inability to undertake the auction the officer should proceed with the auction departmentally The sale proceeds in either case should be credited to the Treasury as miscellaneous receipts under the Proper head of account

XVIII PHYSICAL VERIFICATION (a) The stocks held by officesinstitutions in various sections should be physically

verified twice a yearin the months o f April and October ( b ) Checking should be done by an officer other than te one who holds the charge of

Stores (c) Verification should be done in presence of officer holding the charge of Stores ( d ) All discrepancies found during the verification should be properly investigated

and accounted for

(j) Any excess detected during verification should be entered in the Stock book as Receipts with the remark ldquo Excess found on verificationrdquo

(ii)any shortage should be noted in issues column of lsquo Issuesrsquo described as lsquoshortage fou n d o n v e r i f i c a t i o n rsquo

XIX ANNUAL STORES ACCOUNT This account should be prepared according to the instruction issued from the department from time to time This should account for the outgoing financial year on the following lines -(a) Cost of the articles under various heads on the last day of the previous

year 18

( b ) Cost of the articles under the various Heads Received during the year (c) Cost of various articles written off during the year under review ( d ) Cost of the articles on the last day of the year or on the firs t d a y o f t h e

financial year following

19

Annexure A WardSection Indent Register No Issued on

Name of institution Page Folio No

Serial no Name of Article Quantity in Stock

Quantity required

Prepared by Approved by Recd by Note-Indenting Officer to sign and affix seal with name and

designation below the last item to avoid additions in one strokeno issues to be made by storesif Issue vouchers of

previous Indent has not been returned back by the WardSection

20

Annexure B Issue Voucher No (printed number)

Supplied to Wardsection Date

Indent no

Serial no Name of Article Quantity in Stock

Quantity required SB No

Stores-in MO Resident in Sign of charge charge WardSection

NurseCompounder Prepared by Recd Approved by by

Note-Indenting Officer to sign and affix seal with name and designation below the last item to avoid additions in one strokeno issues to be made by storesif Issue vouchers of previous Indent has not been

returned back 1st copy-Stores 2nd copy -Wardsection3rd copy-Tobe reurned to sores with Stock book entries

21

Annexure C

STOCK REGISTER FOR DEAD STOCKS

SERIAL NO DATE OF RECEIPT

Article with description

No of pieces Cost Details of

Bill Signature No Disposed

Date of disposal

Manner of Disposal

with Authority

Value realised Signature

1 2 3 4 5 6 7 8 9 10 11 12

P r e p a r e d B y C h e c k e d b y A p p r o v e d b y

Date Designation Name of Institution

22

Annexure D

STOCK REGISTER FOR EXPENDABLE ITEMS Name of article

Date

From where

received with cost

Quantity Signature To whom issued Quantity Balance Signature

1 2 3 4 5 6 7 8

23

Annexure E

Receipt amp Issue Register for WARDSSECTIONS (one or more pages as per requiremnt for each medicine)

NAME OF MEDICINE RECEIPT ISSUE

DATE Quantity In Stock

Date of

Issue

Issued toMention Bed no amp

quantity (in bracket) (For

Outdoor cases give Regd No)

Balance Signature

24

Annexure -F

OUTDOOR FREE MEDICINE SLIP In Duplicate

Name of Patient Registered No Date

Sr no Name of Medicine Quantity

Seal amp sign of doctor

25

Annexure-G

TREATMENT CARD

WARD NO

NAME OF PATIENT BED NO DATE amp TIME OF ADMISSION DATE amp TIME OF DISCHARGE

DATE MEDICINES PRESCRIBED SIGNATURE

26

ANNEXURE -H

PROFORMA FOR BREAKAGE amp LOSS

NAME OF OFFICEINSTITUTION DATE PLACE

SRNO NAME amp

DESCRIPTION OF ARTICLE

COST DATE OF PURCHASE

REASON CAUSE OF BREAKAGE

RECOMMENDATION OF INVESTIGATING AUTHORITY

Signature

Orders of the Competent Authority

Signature

27

Annexure ndash I Loss- Procedure for Reporting

1 The exact nature of the defalcation 2 The full extent of loss 3 The actual period covered by the defalcation 4 The defects in the negle c t o f r u le s by w hic h the loss was rendered possible

and circumstances which facilitated the defalcation 5 The names of the officials held personally or technically directly or

indirectly and wholly or partially responsible for the irregularity c o m m i t t e d i n t h e c a s e

6 Whether the c a s e a s b e e n J u d i c i a l l y t r i e d i n a c o u r t o r n o t i f s o c o p i e s ( i n duplicate) of the Judgment may please be furnished Copy of police report may also be furnished

7 The remedial measures adopted as safeguards against the losses hereafter 8 The prospects of re covery of the loss and he action taken to effect

recovery together with the amount recovered 9 Head of Account to which the Loss is debitable may be informed

Signature of Head of Office with seal

NoteA copy of this report is to be sent to AGMPThis is as per M P Finance Code Vol I

28

STORAGE AND STOCK MANAGEMENT

29

Foreword

The New Drug Policy 2009 is being implemented in the State of Madhya Pradesh

In order to have a proper procedure for Storage maintenance and expiry management of the drugs it is necessary to follow Good Storage Practices with Standard Modules for pharmacistStore keepers

Proper guidelines on Storage Practices can lead to better Stores and inventory upkeep with medicines being properly stored in racks with proper cleanliness and hygiene

This is a step towards storage maintenance and expiry management at the various stores in the state Looking forward to see that the heads of all health facilities take benefit from this module

D ir e c t o r M e d i c a l S e r v i c e s

30

INDEX

Sr No P a r t i c u l a r s P a g e

1 S T O R A G E A N D S T O C K M A N A G E M E N T 4

1 Quarantine and checking of stocks 11 Quarantine area 12 Checks to be carried out on new stocks

2 S t o r a g e 21 Need for proper storage 22 Different patterns of storage 23 Different means of storage 24 Temperatureclimatic conditions 25 Special storage of supplies 26 Storage and stability of medicines

3 Stock Control and Expiry Monitoring 31 Stock control 32 Stock rotation and expi r y m o n i t o r i n g

4 Other aspects of storage 41 Design of a storage area 42 Cleaning and maintenance 43 Product recalls 44 Returned goods

2 A p p e n d i x 1 Templates of letters for use if found not of Standard Quality [Frozen and expired goods ]

Frozen Drugs-ordered to return to the Suppliers-reg(New drug policy 2009)

Frozen Drugs-ordered to return to the Suppliers- for issue of gate pass after verification reg(New drug policy 2009) Stop instruction-reg(New drug policy

2009) Appendix II Material handling in drug stores

31

3 PROCUREMENT ndash Government Order Relating to

the Management of Stores

(Reproduced for reference material on basic

procedure in decentralized system followed by

Health facilities in 1977)

54

F L O W C H A R T S f o r a BI R D S E Y E V I E W o f

P R O C U R E M E N T

5 5

ACQUISITION OF STORES 6 1

PLACING OF ORDERS 6 2

RECEIPT OF STORES 6 2

CUSTODY 6 3

ISSUE OF STORES Maintenance of Stock Books

6 3

PROCEDURE OF INDENTING FOR WARD amp OTHER SECTIONS OF THE INSTITUTION

6 4

HOW OFTEN TO INDENT 6 5

EMERGENT INDENT 6 5

HOW TO INDENT 6 5

KEEPING OF RECORDS IN WARDS A N D S E C T I O N S

6 6

ACCOUNTABILITY OF DRUGS BROUGHT BY THE PATIENT OR RECEIVED IN DON A T I O N BY T H E WARDSECTION _IN - CHARGE

6 7

RESPONSIBILITY OF STORES AT VARIOUS LEVELS

6 7

DISTRIBUTION OF MEDICINES FROM OUTDOOR DEPARTMENT

6 7

LOSS BREAKAGE DAMAGE ETC 6 8

PROCEDURE FOR WRITING OFF STORES 6 9

DISPOSAL OF WRITTEN OFF ARTICLES 7 1

FORMATS TO BE USED 7 3 - 81

32

STORAGE AND STOCK MANAGEMENT The expiry periods of pharmaceutical products have meaning only if the products are stored under proper conditions otherwise products are likely to lose their potency before the actual date of expiry

A pharmacist is a vital link in the distribution chain for pharmaceutical products The medicinal products remain for a long period during the distribution cycle at the wholesaler and at retail pharmacies It is therefore very important to maintain proper storage conditions in these units

Every community pharmacy however large or s mall needs to store and manage its medicine stocks effectively There must be systems to ensure

middot bullbull Secure storage middot bullbull Clean and correct environmental conditions during storage middot bullbull Accurate and effective record keeping middot bullbull Effective stock rotation and expiry monitoring middot bullbull Effective fire and theft prevention middot bullbull Effective rodent pest control

For easier un derstanding this module has been divided into the following sections

1 Quarantine and checking of stocks 11 Quarantine area 12 Checks to be carried out on new stocks

2 S t o r a g e 21 Need for proper storage 22 Different patterns of storage 23 Different means of storage 24 Temperatureclimatic conditions 25 Special storage of supplies 26 Storage and stability of medicines

3 Stock Control and Expiry Monitoring 31 Stock control 3 2 S t o c k r o t a t i o n a n d e x p i r y m o n i t o r i n g

4 Other aspects of s t o r a g e 41 Design of a storage area 42 Cleaning and maintenance 43 Product recalls 44 Returned goods

33

1 QUARANTINE AND CHECKING OF STOCKS

11 Quarantine Area D r u g S t o r e pharmacies receive stoc k s f r o m su pplie r s a c c or d ing to pur c h a se o r d e r s T he stock that is received must be visually checked for quality and quantity The stocks must be kept in a separate area until the checking is done to avoid intermixing with existing stock This necessitates the presence of a separate area within the pharmacy w h e r e i n t h e storage and other checking of stocks can be performed This area is called the QUARANTINE AREA This area should be marked and identified adequately to distinguish it from other areas

The area may be marked using different means 1 ) A s m a l l board saying Quarantine on a separate table used exclusively if it is in the middle 2) A board on the wall if the table on which the quarantine stock is placed is against the wall

middot Stock received from wholesalers should be immediately transferred t o t h e Quarantine Area

middot In the Quarantine area the stock may be stored on racks shelves or in cupboards to prevent ingress of moisture dirt and other contaminants

middot Regular stocks from the pharmacy should not be left kept in the quarantine area Special care has to be taken in case of refrigerated medicines supplied by the suppliers so tha t the y do not remain in the quarantine area for long periods of time They should be immediately checked on receipt and transferred to areas for refrigerated storage s o a s to maintain the cold chain bull

Advantages of having a separate Quarantine Area middot Avoids cross mixing of newly arrived stock from existing stock till it is checked middot Lays stress on checking the quality of the stock received middot S to ck checking ensures t hat defective andor expired goods do not enter the storage areas

34

bullbull

bullbull

12 Checks to be carried out on new stock

Unpacking and checking stock

Supplies received should be unpacked and checked in the quarantine area Staff doing the checks should be adequatel y trained in what they have to check when stock arrives

Checking should be seen not simply as counting the units received but as a part of the quality assurance system bullThis should include middot Visually inspecting the packaging middot Checking the integrity of containers middot V erifying the completeness and leg ibility of la b e ls ( a ppr o ve d dr u g name strength any special storage instructions and expiry date)

bull

The expiry dat e should be checked to ensure that there is adequate shelf life remaining

Supplies should be individually checked using a checklist 35

Checklists

36

The wholesaler supplying the product should be notified immediately in case of any discrepancies ( and the details should be recorded in a register) and sent in a written format to the supplier It should include middot Missing boxes or cartons middot O p en tampered boxes or cartons middot Missing supplies middot Differences in the actual quantity and the quantity shown on the packing middot Additional medicines that had not been ordered but have been supplied middot D a m a g e d b r o k e n o r p oor quality medicines middot Any other discrepancies

The purchase invoices are an important aspect to be considered The invoiced documents should be signed and filed for reference as per the Drugs and Cosmetics Act and retained for at least 3years

If the wholesaler supplies medicines as an emergency without a bill or against a delivery challan

middot The supplies should be checked for integrity and inspected for damage middot The details of supplies received should be recorded middot The supplier should be asked t o send the bill as early as possible middot When the bill is received it should be checked against the details recorded and anomalies if any should be reported to the supplier

To keep a track of the received stock maintaining a S t o c k R e c o r d C a r d c a n b e very useful The entries in the stock record card can be made while checking the stock received STOCK BIN in the stores should have Stock record card

Maintaining a stock card for every product may not be very practical for a retail pharmacy however it could be maintained for costly medicines Nowadays it is much more practical and easier to maintain records using computers

The pharmacist should ensure that medicines manufacturedmarketed by a company are received only through an authorized distribution network of that company This is important to prevent spurious and counterfeit drugs from entering the pharmacy

37

2 STORAGE 21 The need for proper storage The storage of medicines and other products is an important requirement of Good Pharmacy Pr actice Appropriate storage of medicines is essential -

middot bullTo ensure that the potency is maintained middot bullTo prevent deteriorationspoilagedegradation middot bullTo ensuremaintain physical integrity

To ascertain that the quality and safety is maintained throughout their shelf life Storage requirements need to be considered on 2 aspects

a) Integrity of medicines Medicines should be stored in such a way so as to maintain their integrity and potency middot Maintain the right temperature required middot Protect from excessive humidity middot Keep medicines away from direct sunlight middot Protect from pests and rodents

b) Physical location middot Should be easy to locate middot Accessible middot Orderlysystematically placed

2 2 D i f f e r e n t p a t t e r n s o f s t o r a g e The pharmacist could follow any of the different patterns of storage The pattern of stora ge should be selected in such a way that it facilitates speedy and efficient dispensing of medicines

The pattern of storage could vary with each pharmacy experience usual practiceroutine of staff and the person-in charge and also depending on space av ailable turnover etc (i) The medicines could be stored c o m p a n y w i s e ie the medicines manufactured by one company should be grouped together and kept in one place Within each company shelfshelves the medicines may be placed in alphabetical order for easy and quick placement and removal Also bottles tubes boxes etc may be segregated within that shelf

38

(ii) The medicines may also be stored in a lphabe t ic al o r de r ie they are placed in order from left to right based on their name The first letter of the name is used to g r o u p t h e m e d i c i n e s t o g e t h e r a n d k e e p t h e m i n o n e l o c a t i o n I n s o m e p h a r m a c i e s a l l t h e strip packing are placed in drawers or boxes in alphabetical order each box or drawer containing strips of one particular alphabet This system ensures that the strips always remain e n c l o s e d i n t h e b o x e s d r a w e r s a n d a r e n o t e x p o s e d t o d u s t T h e d i s a d v a n t a g e i s that it might lead to mix -u p o f strips in the same drawer and it may cause a problem incase of similar looking strips in which case a wrong medicine may be dispensed Secondly cut strips lying around in the drawer may lose their identity if the batch n u m b e r andor expiry date is not seen on the cut portion of the strip

39

(iii) The medicines may be stored according to their therapeutic class ( e g a n t i b i o t i c s anti asthmatics or anti hypertensives) ie the medicines are kept together based on their pharmacological or therapeutic action

(iv) The medicines may be stockedsegregated according to dosage forms eg l i q u i d s (bottles) solid oral dosage forms eye drops rotacaps ointments etc all stored on separate shelves

Always Remember I Storage of prescription medicines should preferably be separate from OTC medicines OTC medicines especially those that a r e a d v e r t i s e d m a y b e d i s p l a y e d f o r c l i e n t s t o select or to ask questions about [OTC-O v e r t h e c o u n t e r ] II Storage according to temperatures is a must no matter which pattern of storage is followed Also within a particular storage area segregated storage may be maintained In a refrigerator for example medicines may be stored in trays racks and the freezer according to the temperature required

40

Whatever pattern of storage is selected all the personnel should ensure that middot The stocks are stored in an orderly manner middot The medicines are kept back in the same place from where they were removed middot All medicines are arranged neatly once in a while

middot The personnel should be careful while storing the medicines middot They should not throw the medicines haphazardly 23 Different means of storage

middot Within each temperature and security zone medicines must be stored so that they are easily accessible and protected against damage

middot Basic means of storage include shelves racks and drawers middot To prevent dust from entering the shelvesracks it is ideal to have glass

shutterssliding glass doors This can however be disadvantageous because accessibilityspeed is hampered in removing a product from the shelf because the glassshuttersliding glass has to be

41

opened m o v e d e v e r y t i m e a p r o d u c t h a s t o b e p i c k e d u p U s e o f a i r c o n d i t i o n e r s f o r t h e p h arm acy with a closed door at the e n t r a n c e o r a n a i r c u r t a i n c a n r e d u c e t h e d u s t problem In such cases the shelvesracks may be left o p e n

bull

middot Direct storage of cartons on the floor should be avoided because besides being an unhealthy practice the contents may also be damaged by moisture bull

middot Store medicines preferably in shelves with glass shutters for visibility middot Closed shelves further prevent dust from going in especially in India where most

pharmacies are located along busy roads middot Some medicines have to be refrigerated or stored in a cool or cold place Having a

refrigerator or two (as per the need of the pharmacy) is essential to store suc h medicines at temperatures mentioned on the label bull

42

Refrigeration middot All cold chain equipment should meet required standards middot Improvement in refrigeration technology has provided frost -free refrigerators

Pharmacists should opt for frost-free refrigerators as they are easy to maintain and protect printed packaging materials Conventional refrigerators may cause water falling from trays below the freezer on medicines stored in the refrigerator thus causing soggy labels

middot bull Frost-free refrigerators also provide separate and large compartments for the freezer portion (required for storing medicines needing sub-z e r o t e m p e r a t u r e ) and the main storage area with separate doors so that opening one door does not disturb the storage temperature in the other compartment

Care should be taken to keep the refrigerator on 24 hours a day It should not be switched off after working hours It is advisable to have an inverter connected to the refrigerator so that the refrigerator re mains working even when there is a power outage

middot The refrigerator door should be closed tightly middot The refrigerator door should not be left open for too long middot Space should be left between medicines stored in a refrigerator to allow air to

circulate middot The ref rigerator should be placed about an arms length away from the wall

This will increase air circulation thus not affecting the cooling within the refrigerator

middot Vaccines should not be stored on refrigerator door shelves as they are exposed to warmer temperatures each time the door is opened Vaccines should always be stored on the middle shelves of the refrigerator

middot Refrigerated medicines should not be left out of the refrigerator for more than a few minutes

43

middot Consumable products like juices energy drinks e t c s h o u l d n o t b e s t o r e d a l o n g with medicines in refrigerators If required they may be kept in a separate refrigerator

middot An adequate number of refrigerators should be planned to store the entire stocks requiring refrigerated storage

middot Adequate procedures should be followed for defrosting cleaning and maintenance of refrigerators

middot Icefreeze packs should be kept in the freezer compartment so that they can be used for transporting cold temperature medicines The packs can be given to clients along with the medicines requiring cold temperature storage so that the temperature is maintained till the client reaches home and can then put the medicines in a refrigerator) Freezer packs can also be used to keep medicines temporarily in case there is a power outage or refrigerator breakdown

Activity

Prepare a SOP (Standard operating procedure chart) for cleaning a refrigerator Discuss it with your staff finalize its maintenance once a month through AMC -A n n u a l Maintenance contract CMC - Comprehensive maintenance contract and put it up on the pharmacy refrigerator Put the Purchase Order details name of manufacturer Phone of Service Engineer and a register to login the Machine service and down timeService reports may be maintained properly

Refrigerator monitoring and maintenance

middot bullIt is important to carry out routine monitoring and maintenance of the refrigerators and to organize an effective repair system

middot bullThe temperature in the refrigerator must be monitored and recorded routinely at least once a day

middot Any breakdown must be reco rded including the period during which the medicines were exposed to uncontrolled temperatures Medicines may then be kept or discarded depending on the problem guidelines or the manufacturers advice

middot Cold chain monitor cards and devices in or on packages that change color or otherwise alert staff to potential damage assist in monitoring (These are likely to be introduced in India soon)

middot It is essential to have a contingency plan in place before a refrigerator breaks down An arrangement can be made to move the contents to a private refrigerator elsewhere in the community or to obtain a regular supply of ice packs until the defect is rectified

Put filled water bottles in the bottom half of the refrigerator door in order to provide cooling in the refri g e r a t o r w h e n t h e r e i s a p o w e r o u t a g e T h i s m i g h t t a k e c a r e o f t h e temperature when there is no current for a couple of hours If the power outage is expected to last for several hours special arrangements such as an inverter UPS have to be made to keep the refrigerator constantly running in the absence of electricity middot Defrost the refrigerator in case of excessive ice formation and preferably at regular

intervals Keep a record of the same

44

2 4 T e m p e r a t u r e c l i m a t i c c o n d i t i o n s

i) Temperature control middot The medicines in a pharmacy need to be stored at appropriate temperatures to

maintain their stability middot An air-conditioned environment where temperature can be controlled is

recommended for pharmacies Air conditioning offers the option of setting the t e m p e rature as per requirements

middot bullIt is ideal to have an air conditioner to maintain the temperature below 25 C as most medicines require storage below this temperature Secondly this temperature is pleasing to both the staff and the visiting customers too

middot In the absence of an air conditioner circulating fans may be used middot This need is felt even more in certain parts of India where temperatures soar above 45

C and some areas where it falls to sub zero temperatures In such cases temperature maintenance is essential to prevent deterioration of medicines due to unnecessary exposure to drastic temperature fluctuations

middot This need is felt even more in certain parts of India where temperatures soar above 45 C and some areas where it falls to sub zero temperat u r e s I n s u c h c a s e s temperature maintenance is essential to prevent deterioration of medicines due to unnecessary exposure to drastic temperature fluctuations

i i ) Humidity or moisture control Moisture or humidity can adversely affect the stability of me dicines such as tablets capsules powders

45

Gelatin capsules become soft and swell on absorption of moisture The drug content of tablets may undergo surface hydrolysis The presence of moisture may encourage the growth of microbes It is therefore essential to control humidity

To reduce the effect of humidity the following suggestions may be followed -middot Open the windows to allow air circulation Use a fan to circulate fresh (outside) air middot In humid climate a dehumidifier is useful for preventing mo i s t u r e d a m a g e ( i n t h e absence of an air conditioner) middot For bulk containers of tabletscapsules do not keep the container open for a long time and replace the lid or closure immediately after taking out the required number of medicines for dispensing middot Do not allow the medicines to touch the floor or the walls The walls may be damp and may cause moisture absorption damaging the product

middot Calibrated thermometers and manometers can be used to detect temperature and humidity in the pharmacy

middot Periodici t y of checking the temperature should be fixed middot The climatic conditions should be recorded and documented middot Temperature charts should be available for ready reference

Documentation is one of the core activities for achieving and maintaining quality It is one of the most essential components of validation Temperatures in various areas

46

including refrigerators should be recorded at a predetermined periodicity usually daily at the hottest time of the day and such documents should be preserved i i i ) Storage conditions A number of storage conditions are mentioned on the labels of medicinal products These conditions have to be properly interpreted and appropriately complied with

According to the Drugs and Cosmetics Rules 1945

1 The term cool place means a place having a temperature between 10 C and 25 C

2 The term cold place means a place having a temperature not exceeding 8 C In case of storage conditions for specific products please refer to Schedule P The Drugs and Cosmetic Rules 1 9 4 5

The Indian Pharmacopoeia specifies the following storage conditions -

Wherever the condition for storage is not specified medicines may be stored under normal temperature In a country like India however where normal temperatures soar to h i gh temperatures it is recommended that medicines be stored in a cool place

Activity Prepare a list of the storage requirements mentioned on the label of about 20 products in your pharmacy and check if the temperature is maintained

47

25 Special Storage o f s u p p l i e s If the product has no special instructions normal storage conditions apply This means storage in dry clean w e l l -ventilated premises at temperatures of +15 C to +25 C or depending on the climate up to +30 C (WHO1990) Storage instructions are product specific Different brands of the same generic drug may have different storage requirements as they may have different packaging or formulations It is essential to follow the product manufacturers storage instructions to the maximum extent possible Less stable medicines must be stored in specific conditions to maintain their quality or potency

The following products require special storage facilities

middot Products that must be kept frozen (usually vaccines and sera) middot Products sensitive to h eat an d r e q uir in g r e f r ig e r a tio n ( +2 C to +8 C) middot Products that have reduced shelf life at uncontrolled room temperature and need

mechanical ventilation or air conditioning middot Flammable products that require separate fireproof premises middot Products prone to theft o r m i s u s e

Products needing storage in a controlled environment -

The usable shelf life of the following products may be reduced if stored at uncontrolled humidity or at room temperature in hot climates -

middot Some injectables (eg adrenaline) Most injectable preparations are less stable than solid oral forms (tablets and capsules) Injectable preparations in solution are particularly unstable Many injections must be protected from light as well as heat

middot Intravenous fluids (particularly if packed in p lastic containers) middot Some suppositories pessaries creams and ointments These products may melt at

temperatures greater than 30 C Once this happens it is not advisable to use them because the active ingredient in the formula may get unevenly distributed

middot Products containing rubber latex cellulose or some plastics Condoms most sterile disposable medical devices and surgical products such as syringes needles and catheters require protection from excessive humidity and strong light and heat Any o f these conditions may make products brittle stained amp unusable Sterility cannot be assumed if packaging is damaged

In hot climates these products should be stored in the coolest place possible preferably with air conditioning or air circulation fans

48

Products needing freezing or refrigeration-middot Vaccines blood products and many other medicines lose potency if kept even for a

brief period at temperatures outside the recommended range For these products the cold chain must be maintained at every stage of the distribution system

middot Freezing is as damaging as high temperatures for some products including injectable contraceptives ergometrine insulin adrenaline and the DPT DT TT and Hepatitis B vaccines Such products therefore sho uld not be allowed to freeze (not be kept in the freezer compartment)

middot Short periods at room temperature (during transportation or local distribution for instance) may be acceptable for many products (such as ergometrine a n d i n s u l i n ) e v e n t h o u g h s u c h e x posure can to some extent reduce shelf life Other items such as vaccines should always be transported in cold boxes

Storage of insulin injections-

middot Insulin should always be stored in a refrigerator at the recommended temperature of 2 -8 C

middot Insulin should not be kept in the freezer compartment of the refrigerator middot Insulin should ideally be stored horizontally middot It should not be exposed to sunlight or excessive heat middot Insulin suspensions should not be used if the suspension cannot be properly

resuspended due to cake or clump formationbull

Controlled drugs -Narcotics (for example Pethidine injection morphine preparations) and other specified drugs that may be abused are governed by special legislation and regulations The following security measures are suggested in the pharmacy -middot A safe or reinforced double locked cabinet fitted with a light (preferably with a red

bulb) that comes on when the door is opened

49

middot A special register recording details of each receipt or issue with 2 signatures physi cal counting of medicines after each entry and signatures at handover takeover

middot Independent audit (by supervisors and drug inspectors)

Products prone to theft abuse or misuse -

Some medicinesproducts are particularly prone to theft abuse or misuse These include expensive medicines (eg insulin) certain antibiotics and products prone to abuse or misuse like psychotropics etc

Such medicinesproducts should be stored adequately They require stricter record keeping and more frequent stock taki ng than others Periodic audits should be carried out to check for consumption against actual recorded use (registers prescription records stock records etc) to expose any theft or misuse bull26 Storage and stability of medicines Medicines are not stab le indefinitely They are stable for a specific period of time sometimes for a brief period Poor storage conditions accelerate the drug degradation (decomposition) Temperature light and moisture are the most important contributing factors for drug instability It is important to identify and be aware of the potential for instability There is a need to comply with storage requirements to ensure quality medicines for patients It is also important to offer advice to patients too about appropriate storage o f medicines at home The dispensing label should state the storage condition required and be backed up by a verbal reminder especially where special storage is required bull

50

In case stability and storage problems are seen with formulations they should be reported immediately to the representative of the manufacturer and taken out of circulation till the stability problems have been resolved

The pharmacist can easily detect stability problems when products show change in appearance color odor settling of the product contents breaking of emulsions melting of creams oozing of contents from the containers and any such physical changes

3 STOCK CONTROL AND EXPIRY MONITORING 3 1 S t o c k C o n t r o l For economic reasons pharmacists do not like to have stock on their shelves for long periods of time The aim should always be to keep stock at a level that will just meet demand Normally most manufactured medicines have a long shelf life Even then it is essential that there is efficient stock rot ation so that the older stock is used first It is also a good practice to check the expiry date as an integral part of the dispensing process When short shelf life products are involved stock levels may have to be modified to prevent medicines regularl y expiring on the shelves

32 Stock rotation and expiry monitoring In order to avoid accumulation of expired and obsolete stock medicines should be stored and issued according to the following guidelines -middot The stock control system must record the ex p i r y d a t e a n d t h e d a t e o f r e c e i p t middot Stock must be stored so that earliest expiring batches are picked and issued first middot The First In First Out (FIFO) system - In this system the stock which is received

first is sold first This system however may not be useful for pharmacies because most of the stocks carry an expiry date For pharmacies the FEFO system is more practical

51

middot The First Expiry First Out (FEFO) system - In this system the stock having an earlier expiry is sold first The stock with longer shelf life should be placed farthest to the back (or at the bottom in case o f sta c k e d b oxe s) T h is is pa r tic u la r ly impor ta n t with products that have short shelf lives such as vaccines some vitamins antibiotics etc and reduces losses due to expiry

middot E x p i r y dates should be noted on the stock record upon receipt Stock nearing expiry should not be accepted unless it can be used before expiry

Computerization and expiry monitoring In the pharmacy computerization facilitates both checking stocks and expiry mo nitoring and helps-bullbullKeeping a check on products nearing expiry bullbullKeeping a check on non- moving and slow moving products bullbullTo facilitate the removal of medicines nearing expiry from shelves in time to send them back to the wholesaler or supplier

Periodic checking for expiry The expiry date for medicinal products is a critical aspect in pharmaceutical dispensing and due importance should be given to it Periodic checking for expiry of medicines will ensure that the patient will never receive products that have crossed their expiry date During periodical checking of expiry the personnel involved should remove medicines that are nearing expiry bullbullIn -house threshold periods should be set and followed for retrieval of such medicines from the shelves bullbullSuch medicines should be stored separately These should either be dispensed immediately (thus ensuring that they are used before the expiry date) o r t h e y s h o u l d b e returned to the suppliers bullbullA separate area should be designated (cupboard or shelf)marked[FROZEN ZONE] which is adequately marked EXPIRED GOODS- NOT FOR SALE to store all expired stocks FROZEN ZONE

52

Remember Expired medicines are a NATIONAL WASTE So stock only what you can sell Avoid expiries save precious medicines for the nation

Treatment and disposing of expired medicines bullbullProcedures need to be in place for the treatment of expired medicines bullbullThe expired medicines need to be collected and be sent back to the supplier or company for appropriate disposal bullbullRecords must be maintained for expired medicines and how they are disposed off bullbullIn case of medicines that are not returnable to suppliers procedures for disposal need to be followed by the pharmacy in conjunction with the FDA The following procedure can be followed if medicines cannot be returned to suppliers ( T h e b a s i c p h i l o s o p h y of appropriate disposal is to prevent their re- circulation and use) bullbullC u t t h e c o n t ainer in such a manner that the label is also cut In case of tablets and c a p s u l e s d e s t r o y them by disposing them in a bucket of water bullbullUse landfill procedures (deep burial into the ground as per stipulations of Medical Waste Disposal Act prevalent in the respective state) bullbullPour the liquids into the sink and wash away with sufficient quantity of water bullbullKeep a record of such disposal with full details of medicines destroyed Although these measures are usually adopted care has to be taken with such tr e a t m e n t a s studies have shown that flushing of medicines has resulted in tracessmall quantities of medicines being found in waterways and groundwater having potential health and environmental effects

4 O T H E R A S P E C T S 41 Design of storage areas The following important factors need to be considered in design of storage areas -middot The retail outlets in hot areas in summers should be air-conditioned Similarly in

a r e a s o f e x t r e m e c o l d t h e p r e m i s e s w o u l d r e q u i r e w a r m i n g e s p e c i a l l y i n w i n t e r s t o maintain cool temperatures The placement of air -conditioners and heating devices should be such that medicines are not directly exposed to the cold or heat

middot Due consideration should be given to storage requirements of formulations while designing shelves and cupboards in retail outlets Sufficient shelf height should be provided so that all liquid products can be stored vertically As far as possible the shelves should be covered with glass panels to protect medicines from dust and p r e v e n t r a p i d f l u c t u a t i o n s i n temperature

middot Medicines should be stored according to the storage instructions on the labels bullIt is ideal to have a door at the pharmacy entrance to prevent dust from coming in as well as reduceprevent cooled air from going out This may not however be considered feasiblepracticable by many pharmacy owners for fear that clients may not enter the pharmacy because the door may act as a barrier An air curtain is a good alternative to a door

middot There should be minimal direct sunlight falling on the products Particular consideration should be given to premises directly facing the sun

middot bullThe arrangement of lighting in the interior of the premises should also be in a manner that the lights are not focused on the products It has been shown that light causes not only chemical damage but also can catalyze physical changes like moisture uptak e by the products Care should be taken to ensure that only diffused light falls on them

53

middot As far as possible provision should be made for a temperature and humidity indicator device in a pharmacy These devices are now easily available

middot Stability studies o f m e d i c i n e s p a c k e d i n b l i s t e r s h a v e r e v e a l e d t h a t i f t h e s e a r e exposed to light they tend to absorb moisture It is therefore necessary to store them in suitable cartons so that the blisters are not exposed to light Pharmacists should do this even if the manufacturer has not provided cartons

middot Light and temperature sensitive products should not be stored on counters where the light is intense or direct and there is no protection from temperature and humidity

42 Cleaning and maintenance i) Cleaning of storage areas

The storage areas of the pharmacy should be cleaned periodically and cleanliness should be maintained at all times The Standard Operating Procedure for cleaning should be designed and followed accordingly Schedules for cleanups should be laid down and adequate cleaning equipment should be made available

Tips for maintaining cleanliness middot Provide clean pieces of cloth for wiping at various locations in the pharmacy

Replace with clean cloth at regular intervals middot Keep separate pieces of cloth for floors shelves and medicines middot Use a disinfectant andor soap solution to clean floors middot Ensure removal of dust and prevent accumulation of dirt middot Ensure removal of cobwebs middot Use a vacuum cleaner for cleaning areas not easily reachable middot T a k e c a r e t h at breakages are handled and cleared effectively middot Observe the factors leading to waste generation in the pharmacy and take appropriate

measures to tackle the problem middot Record all cleaning procedures performed and maintain all the documents required

For ex a m p l e -bullbullThe floor of the pharmacy may be swept with a broom and swabbed with soap water every morning bullbullThe floor may be swabbed with a disinfectant every week bullbullThe entire premises including shelves and cupboards may be cleaned with a cloth (to remove dust and to check for medicines approaching expiry date or expired medicines) every three months bullbullAll the steps followed should be r e c o r d e d

The floor shelves drawers have to be cleaned and a check should be kept on dust cobwebs spillages due to breakage etc It is therefore essential to have SOPs for cleaning laying down cleaning frequencies allotting responsibilities and maintaining a daily record in the logbook to document all these activities

54

While cleaning dust settled on dosage forms like bottles tubes etc should be removed Before dispensing the products should also be wiped to remove any dust settled during storage

For refrigerators bullbullDefrosting and cleaning should be done at regular intervals bullbullSwitch off the refrigerator while cleaning bullbullCleaning should be done quickly and stocks put back immediately

i i ) Pest control Pests are a serious problem in India where insects reptiles and rodents (eg cockroaches l i z a r d s r a t s s i l v e r f i s h (Deemak - in Hindi ) etc) may find access to the pharmacy storage areas Insects like ants and borer ants may often attack wood in the pharmacy causing d am ag e to shelves cupboardsPest c ontr o l in a p h a r m a c y c a n b e a d i f f i c u l t t a s k b u t t o avoid possible contamination and physical damage to stock it is necessary to keep pests out of the pharmacy premisesPest control measures should be implemented with proper p r e c a u t i o n s t a k i n g u t m o s t c a r e t o a v o i d contamination of medicines

55

Th e following pest control measures c a n be ta ke n f r om tim e to tim e -bullbullRat bait and traps can be placed at various locations bullbullInsecticutors can be used on a permanent basis bullbullInsecticidal sprays and repellants can be used from time to time

i i i ) Fire precautions

Combustible trash such as cartons boxes and other packing waste must not be allowed to accumulate in the store Waste should be deposited in appropriate waste bins and be d i s p o s e d o f f o n a d a i l y b a s i s

F i re detection and fire fighting equipment must be maintained and regularly inspected The pharmacy personnel should receive adequate training in fire fighting techniques and emergency actionFire prevention measures should include a prominently displayed ldquoNoSmokingrdquo sign careful handling and disposal of combustible waste materials and checking of electrical connections at regular intervals

iv) Security middot Doors shutters of the pharmacy should be strong and be fitted with secure locks middot Counters should be designed so that unauthorized personnelclients do not have

access to areas where prescription medicines are stored Access to such areas should be restricted to the pharmacy staff

middot All the pharmacy staff handling supplies should be accountable for their ac t i o n s

56

middot bullSpecial care must be taken in case of Schedule X and manufactured drugs (under NDPS Act) Such medicines should be kept under lock and key and the key should be kept with the Chief Pharmacist or i n h i s a b s e n c e t h e s e n i o r p h a r m a c i s t

v) Breakagespillage and damaged product Products that have been damagedspoiled during storage and handling spillages and broken glassware should be disposed off according to procedures laid down by the pharmacy Broken and damaged products s h o u l d b e p l a c e d i n a segregated area to be returned to the supplier

vi) Inspection Senior staff should inspect all pharmacy areas regularly The shelves and drawers should b e c h e c k e d d a i l y f o r signs of pests and dust Ceiling and walls should be checked for dirt and cobwebs Stock should be checked on a regular basis for deterioration due to climatic conditions

43 Product recalls Products found to be defective should be quickly recalled (withdrawn from the market) The instructions are generally issued either by the manufacturer or the regulatory agency The level of recall is determined by both the degree of risk and the extent of distribution of the product and in India is mainly directed at the distribution chain

On receiving the details of the defective substandard spurious batchbatches of a medicine to be recalled from the manufacturer or the stockist or the FDA the pharmacy should immediately check if the particular b a t c h i s i n s t o c k a n d i f s o s u s p e n d i t s s a l e immediately

Similarly if the regulatory authority in the country bans a particular medicine or FDC the pharmacy should immediately check and remove all the different brands of that particular medicine under consideration

The details of medicines and their batches to be recalled should be available in the q u a r a n t i n e a r e a w h e r e stocks are received and checked This is to ensure that such medicines do not come into the pharmacy

middot The pharmacy should develop SOPs for recall of medicines middot The pharmacy staff should be immediately informed about such medicines and

the details should be displayed in writing in a prominent place in the pharmacy middot Rapid action helps avoid unnecessary exposure to such medicines once the

problem has been d e t e c t e d middot The progress of the recall procedure in the pharmacy should be monitored every

few days to ensure complete compliance middot All stocks of the recalled products should be stored separately from the saleable

stock These can be stored in the expiry cupboard segregated from the expired goods and be appropriately labeled ldquoRecal l e d G o o d s - Not for Salerdquo

The supplier should be notified and asked to replace defective products middot All the details of the procedures followed should be duly recorded in a Recall

Register maintained specially for the purpose The register should include d etails such as -middot Date of the recall middot Nam e of the product

57

bullbull

middot Details of the product (name of manufacturer batch number expiry date) middot Nu m b er of units purchased sold a n d sto c k in ha nd middot Reason for recall middot Nam e of the supplier to whom produc ts w e r e returned along with the date and quantity middot Name and signature of the designated personnel carrying out the recall procedure and recording details middot Name and signature of the chief pharmacist verifying the recall procedures and recording details 4 4 Returned medicines

Medicines may be returned to the pharmacy by clients due to the following reasons -bull

bullbull Unused medicines bullbull Course not completed bullbull Therapy changed by doctor bullbull Side effects experienced by patient bull

bullbull DamagedDefective medicines bullbull Missing or defaced label bullbull Missing tablets in a stripblister bullbull Leakage in bottles bullbull Leakage in strips bull

bullbull Expired medicines

Appropriate SOPs should be framed and followed for their acceptancerefusal and disposal middot bull For unused medicines returned by clients the p harmacy personnel should verify

that these were purchased from their pharmacy They should then be checked for integrity of the packing the dosage form and the expiry date and verified with the client whether they were stored in appropriate conditions This again is at the discretion of each pharmacy

middot The damageddefective medicines returned to the pharmacy should be taken back and stored separately Existing stock of the same product should be checked for similar defects

middot Expired medicines should be accepted from clients at the discretion of the pharmacist and be immediately shifted to the expired goods cupboard These can be stored segregated from the pharmacys own expired goods and be appropriately labelled ldquoExpired Goods returned by clients- Not For Salerdquo

It is advisable not to accept returned medicines requiring cold chain storage (refrigeration) because it cannot be ensured that the cold chain was maintained when the medicines were in the hands of the patientclient middot Appropriate adjustments in t he stocks should be made for medicines

returnedexchanged to update the inventory middot The medicines should then be returned to the respective shelves middot A lsquoReturned Goodsrsquo register needs to be maintained to record all details of returned

medicines

R egister should include such details as-

58

middot N a m e o f t h e p a t i e n t middot Nam e of the product and quantity r e tu r n e d middot Product details such as the batch number and expiry date middot Condition in which received middot Reason for returning products middot Compensatory measures taken wi t h r e s p e c t t o c l i e n t middot Action taken with respect to product middot Name and signature of the personnel accepting the returned medicines and recording details middot Name and signature of the chief pharmacist verifying the recorded details

What the pharmacist would have learnt from this module The storage of medicines is a critical factor in the distribution cycle bullbull Stocks received by the pharmacy should be quarantined in a separate area and necessary checks s h o u ld be performed to ascertain the qua lity a nd quantity of stocks received bullbull Whatever pattern and means of storage used the products should be stored so as to maintain their potency and integrity bullbull Storage conditions should be monitored and maintained on a regular basis bullbull Optimum stock levels should be maintained and regularly monitored for expiry bullbull The design of storage areas should facilitate appropriate storage of medicines bullbull Cleanliness should be maintained in the pharmacy bullbull Adequate measures should be taken in case of returned medicines and recalled products

Optimum storage of medicines is mandatory whether at the distribution stage at the pharmacy or ultimately within the homes of patients The pharmacist has an important r o l e t o p l a y i n t h e s t o r a g e o f m e d i c i n e s i n m a i n t a i n i n g d r u g p o t ency and efficacy and thus facilitating optimum therapeutic benefits Good Pharmacy Practice - IPA -CDSCO - WHO Appendix I Quality Assurance Templates of letters for use if found not of Standard Quality [Frozen and expired goods ]

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated To Name of the Supplier with address

Sub Not of Standard Quality GoMP-Supply of Drugs and medicines-(Codename) Return of Stocks to the Suppliers-reg(New drug policy 2009) Previous letterinvoice ref Sl No Drug Code Drug name

Manufacturing date Expiry date

Supplier address

B a t c h n o

The above items of PO nodated was drawn by the Drug Inspector (Place) on (______________date) as a statutory sampling and declared ldquoNot of Standard

59

Qualityrdquo on -(______________date) by the Government Analyst for the following reasons

- ldquoThe product sample do not confirm to IP specification for (Drug codename with respect to the content of drugrdquo

- ldquoThe product has already been blacklisted by TNMSC on -(______________date) for the failure of (quantity) of batches of drug codenamerdquo

As per the clause of the te nde r d oc um e nt ldquo I f the sa mple s d o not c onf o r m to statutory standardsthe tenderer will be liable for relevant action under the existing laws and the entire stock in such batch should be taken back by the tenderer within a period of 30 days o f t h e r e c e i p t o f t h e l e t t e r f r o m t h e v e n u e

The stock shall be taken back at the expenses of the tendererthe Procurement Authority have the right to destroy such Not of Standard Quality if the tenderer does not take back the goods within the stipulated time

The Procuring Authority will arrange to destroy the Not of Standard Quality drugs within 90 days after the expiry of 30 days mentioned above without further notice and shall also collect demurrage charges calculated at the rate of 2 per week on the value of the drugs rejected till such destructionrdquo

Hence we regret to inform you that you will have to take back the stocks available of the abovesaid batch at your own cost from the drug stores where you have supplied the above batch

Kindly acknowledge the receipt of this reference at once

P r o c u r e m e n t A u t h o r i t y Seal and Stamp

Copy to Ref No dated

1 ) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated13082010

To

Sub Frozen Drugs-ordered to return to the Suppliers-reg(New drug policy 2009) Previous letterinvoice ref

The following products which were earlier frozen have now been ordered to return to suppliers directly with permission from the State drug Authority In this regard the suppliers have been instructed to take back their failed batch from the drug store of the stores Hence you are now instructed to return the following failed batches to the suppliers by obtaining proper authorization letter and acknowledgements from them

60

Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

Kindly acknowledge the receipt of this reference at once

Procurement Authority Seal and Stamp

Copy to

Ref No dated 2) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated14092010

To

Sub Frozen Drugs-ordered to return to the Suppliers- for issue of gate pass after verification reg(New drug policy 2009) Previous letterinvoice ref

The following products which were earlier frozen have now been released Hence they may be issued Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

Kindly acknowledge the receipt of this reference at once

Procurement Authority Seal and Stamp

Copy to

61

Ref No dated 3) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated

To

Sub Stop instruction-reg(New drug policy 2009) Previous letterinvoice ref

Until further instructions stop issue all the batches of the following item Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

You must intimate the available stock in the stores of the said batch Number to the Procurement Authority immediately Also retrieve quantity if already issued

Procurement Authority Seal and Stamp

Copy to

Ref No dated 4) HOD Procurement Office of

62

Appendix II Material handling in drug stores

Rack approx rates and dimensions

S No

Item Description UOM Approx Rate

1 MEDIUM DUTY RACK SIZE 2900 H X 3090 W X 800 D IN MM (AS PER SPECIFICATION)

Each 2499800

2 MEDIUM DUTY RACK ADD ON UNIT FOR SIZE OF SR NO2

Each 2243100

To locate a Box no 3 Rack no 14 in row3

SAMPLE OF RACK no Bin numbering -------------- S a y R K 1 4 R o w 3 B o x 1 6

SAMPLE LAYOUT of RACKS in a Drug Stores

63

Sample of another warehouse of distribution warehouse system

64

65

Slotted Angle racks with bin cards

66

Plastic Pallets

Plastic pallets ar e l i g h t w e i g h t l o w- c ost and exceed industry standards for strength and durability

NOTE A pallet has bottom deckboards (see sketch) A skid does not have bottom

67

deckboards

Battery Operated Stacker

Electric Stacker Ehh (Manual Push Type) - Manual drive - Lifting electrically with Battery 12 V 88 Ah - For loading and un-loading of trucks - Battery and loading device built - in - Battery charge gauge and charging current gauge Simple and Easy Operation - Lifting and Lowering electrically direct on steering arm - Pulling and pushing through steering arm - Electrically operated relief valve on hydraulic aggregate Safe Operation - Emergency Off Switch - Constant lowering speed - Protection through lowering brake valve - Overload protection through overload brake valve - Load chains covered preventing pinching threat - Electrically interlocking during loading process - Secured battery compartment opens upwardly - Stable buffering of the steering arm in upright position - In accordance with EWG Guidelines 89 240 - In accordance with VBG 12b Prevention of Accidents

Pallet Truck [ Top ]

68

----------------------------------------------------------------------------------------------------------------------------

For Transport Of All Goods On Pallets Safe and Easy Operation - through single hand operation Lifting moving

lowering with steering handle - neutral position of the hydraulic possible - overload pressure relief valve Long Service Life - robust co n s t r u c t i o n

- special hardened axles - hardened chromium plated ram - maintenance free Easy Maneuverability - through rubber steering rollers - nylon fork rollers

A h a n d t r o l l e y

69

Trolley with plastic bins for several items del ivery

70

Digital Weighing balances

Balances amp Scales EF Seriers Precision Electronic Balance

71

1

Ice lined Refrigerators

600 litres refrigrator

72

Walk in cooler

vacuum cleaner

73

In Institutions where there is only one doctor a list of articles to be condemned should be p r e p a r e d a n d o r d e r s o n i t b e o b t a i n e d f r o m t h e inspecting authority during inspection

While preparing any list of articles for condemnation details regarding the date of purchase date of receipt period during which it remained in use usual life of the article and its purchase price should be noted against each item

( d ) The condemned articles should not be struck off the Stock Register till the competent authority sanctions its write ndashoff Details of Authority under which the article has been written off should be mentioned in stock register

XVII DISPOSAL OF WRITTEN OFF ARTICLES

Articles like linen should be torn into strips 10cm width so that they could be burnt or given to Government Jails for making carpets

Items like bed -pans bowlsurine po ts etc should be crushed and kept for auction

Brass utensils have also to be crushed to destroy their shape and could be either auctioned or after inviting rates from several dealers could be locally sold to highest bidder

In case when condemned ar ticles have to be sold by public auction they should be stored safely and the Government Auctioneer be intimated In case he expresses his inability to undertake the auction the officer should proceed with the auction departmentally The sale proceeds in either case should be credited to the Treasury as miscellaneous receipts under the Proper head of account

XVIII PHYSICAL VERIFICATION (a) The stocks held by officesinstitutions in various sections should be physically

verified twice a yearin the months o f April and October ( b ) Checking should be done by an officer other than te one who holds the charge of

Stores (c) Verification should be done in presence of officer holding the charge of Stores ( d ) All discrepancies found during the verification should be properly investigated

and accounted for

(j) Any excess detected during verification should be entered in the Stock book as Receipts with the remark ldquo Excess found on verificationrdquo

(ii)any shortage should be noted in issues column of lsquo Issuesrsquo described as lsquoshortage fou n d o n v e r i f i c a t i o n rsquo

XIX ANNUAL STORES ACCOUNT This account should be prepared according to the instruction issued from the department from time to time This should account for the outgoing financial year on the following lines -(a) Cost of the articles under various heads on the last day of the previous

year 18

( b ) Cost of the articles under the various Heads Received during the year (c) Cost of various articles written off during the year under review ( d ) Cost of the articles on the last day of the year or on the firs t d a y o f t h e

financial year following

19

Annexure A WardSection Indent Register No Issued on

Name of institution Page Folio No

Serial no Name of Article Quantity in Stock

Quantity required

Prepared by Approved by Recd by Note-Indenting Officer to sign and affix seal with name and

designation below the last item to avoid additions in one strokeno issues to be made by storesif Issue vouchers of

previous Indent has not been returned back by the WardSection

20

Annexure B Issue Voucher No (printed number)

Supplied to Wardsection Date

Indent no

Serial no Name of Article Quantity in Stock

Quantity required SB No

Stores-in MO Resident in Sign of charge charge WardSection

NurseCompounder Prepared by Recd Approved by by

Note-Indenting Officer to sign and affix seal with name and designation below the last item to avoid additions in one strokeno issues to be made by storesif Issue vouchers of previous Indent has not been

returned back 1st copy-Stores 2nd copy -Wardsection3rd copy-Tobe reurned to sores with Stock book entries

21

Annexure C

STOCK REGISTER FOR DEAD STOCKS

SERIAL NO DATE OF RECEIPT

Article with description

No of pieces Cost Details of

Bill Signature No Disposed

Date of disposal

Manner of Disposal

with Authority

Value realised Signature

1 2 3 4 5 6 7 8 9 10 11 12

P r e p a r e d B y C h e c k e d b y A p p r o v e d b y

Date Designation Name of Institution

22

Annexure D

STOCK REGISTER FOR EXPENDABLE ITEMS Name of article

Date

From where

received with cost

Quantity Signature To whom issued Quantity Balance Signature

1 2 3 4 5 6 7 8

23

Annexure E

Receipt amp Issue Register for WARDSSECTIONS (one or more pages as per requiremnt for each medicine)

NAME OF MEDICINE RECEIPT ISSUE

DATE Quantity In Stock

Date of

Issue

Issued toMention Bed no amp

quantity (in bracket) (For

Outdoor cases give Regd No)

Balance Signature

24

Annexure -F

OUTDOOR FREE MEDICINE SLIP In Duplicate

Name of Patient Registered No Date

Sr no Name of Medicine Quantity

Seal amp sign of doctor

25

Annexure-G

TREATMENT CARD

WARD NO

NAME OF PATIENT BED NO DATE amp TIME OF ADMISSION DATE amp TIME OF DISCHARGE

DATE MEDICINES PRESCRIBED SIGNATURE

26

ANNEXURE -H

PROFORMA FOR BREAKAGE amp LOSS

NAME OF OFFICEINSTITUTION DATE PLACE

SRNO NAME amp

DESCRIPTION OF ARTICLE

COST DATE OF PURCHASE

REASON CAUSE OF BREAKAGE

RECOMMENDATION OF INVESTIGATING AUTHORITY

Signature

Orders of the Competent Authority

Signature

27

Annexure ndash I Loss- Procedure for Reporting

1 The exact nature of the defalcation 2 The full extent of loss 3 The actual period covered by the defalcation 4 The defects in the negle c t o f r u le s by w hic h the loss was rendered possible

and circumstances which facilitated the defalcation 5 The names of the officials held personally or technically directly or

indirectly and wholly or partially responsible for the irregularity c o m m i t t e d i n t h e c a s e

6 Whether the c a s e a s b e e n J u d i c i a l l y t r i e d i n a c o u r t o r n o t i f s o c o p i e s ( i n duplicate) of the Judgment may please be furnished Copy of police report may also be furnished

7 The remedial measures adopted as safeguards against the losses hereafter 8 The prospects of re covery of the loss and he action taken to effect

recovery together with the amount recovered 9 Head of Account to which the Loss is debitable may be informed

Signature of Head of Office with seal

NoteA copy of this report is to be sent to AGMPThis is as per M P Finance Code Vol I

28

STORAGE AND STOCK MANAGEMENT

29

Foreword

The New Drug Policy 2009 is being implemented in the State of Madhya Pradesh

In order to have a proper procedure for Storage maintenance and expiry management of the drugs it is necessary to follow Good Storage Practices with Standard Modules for pharmacistStore keepers

Proper guidelines on Storage Practices can lead to better Stores and inventory upkeep with medicines being properly stored in racks with proper cleanliness and hygiene

This is a step towards storage maintenance and expiry management at the various stores in the state Looking forward to see that the heads of all health facilities take benefit from this module

D ir e c t o r M e d i c a l S e r v i c e s

30

INDEX

Sr No P a r t i c u l a r s P a g e

1 S T O R A G E A N D S T O C K M A N A G E M E N T 4

1 Quarantine and checking of stocks 11 Quarantine area 12 Checks to be carried out on new stocks

2 S t o r a g e 21 Need for proper storage 22 Different patterns of storage 23 Different means of storage 24 Temperatureclimatic conditions 25 Special storage of supplies 26 Storage and stability of medicines

3 Stock Control and Expiry Monitoring 31 Stock control 32 Stock rotation and expi r y m o n i t o r i n g

4 Other aspects of storage 41 Design of a storage area 42 Cleaning and maintenance 43 Product recalls 44 Returned goods

2 A p p e n d i x 1 Templates of letters for use if found not of Standard Quality [Frozen and expired goods ]

Frozen Drugs-ordered to return to the Suppliers-reg(New drug policy 2009)

Frozen Drugs-ordered to return to the Suppliers- for issue of gate pass after verification reg(New drug policy 2009) Stop instruction-reg(New drug policy

2009) Appendix II Material handling in drug stores

31

3 PROCUREMENT ndash Government Order Relating to

the Management of Stores

(Reproduced for reference material on basic

procedure in decentralized system followed by

Health facilities in 1977)

54

F L O W C H A R T S f o r a BI R D S E Y E V I E W o f

P R O C U R E M E N T

5 5

ACQUISITION OF STORES 6 1

PLACING OF ORDERS 6 2

RECEIPT OF STORES 6 2

CUSTODY 6 3

ISSUE OF STORES Maintenance of Stock Books

6 3

PROCEDURE OF INDENTING FOR WARD amp OTHER SECTIONS OF THE INSTITUTION

6 4

HOW OFTEN TO INDENT 6 5

EMERGENT INDENT 6 5

HOW TO INDENT 6 5

KEEPING OF RECORDS IN WARDS A N D S E C T I O N S

6 6

ACCOUNTABILITY OF DRUGS BROUGHT BY THE PATIENT OR RECEIVED IN DON A T I O N BY T H E WARDSECTION _IN - CHARGE

6 7

RESPONSIBILITY OF STORES AT VARIOUS LEVELS

6 7

DISTRIBUTION OF MEDICINES FROM OUTDOOR DEPARTMENT

6 7

LOSS BREAKAGE DAMAGE ETC 6 8

PROCEDURE FOR WRITING OFF STORES 6 9

DISPOSAL OF WRITTEN OFF ARTICLES 7 1

FORMATS TO BE USED 7 3 - 81

32

STORAGE AND STOCK MANAGEMENT The expiry periods of pharmaceutical products have meaning only if the products are stored under proper conditions otherwise products are likely to lose their potency before the actual date of expiry

A pharmacist is a vital link in the distribution chain for pharmaceutical products The medicinal products remain for a long period during the distribution cycle at the wholesaler and at retail pharmacies It is therefore very important to maintain proper storage conditions in these units

Every community pharmacy however large or s mall needs to store and manage its medicine stocks effectively There must be systems to ensure

middot bullbull Secure storage middot bullbull Clean and correct environmental conditions during storage middot bullbull Accurate and effective record keeping middot bullbull Effective stock rotation and expiry monitoring middot bullbull Effective fire and theft prevention middot bullbull Effective rodent pest control

For easier un derstanding this module has been divided into the following sections

1 Quarantine and checking of stocks 11 Quarantine area 12 Checks to be carried out on new stocks

2 S t o r a g e 21 Need for proper storage 22 Different patterns of storage 23 Different means of storage 24 Temperatureclimatic conditions 25 Special storage of supplies 26 Storage and stability of medicines

3 Stock Control and Expiry Monitoring 31 Stock control 3 2 S t o c k r o t a t i o n a n d e x p i r y m o n i t o r i n g

4 Other aspects of s t o r a g e 41 Design of a storage area 42 Cleaning and maintenance 43 Product recalls 44 Returned goods

33

1 QUARANTINE AND CHECKING OF STOCKS

11 Quarantine Area D r u g S t o r e pharmacies receive stoc k s f r o m su pplie r s a c c or d ing to pur c h a se o r d e r s T he stock that is received must be visually checked for quality and quantity The stocks must be kept in a separate area until the checking is done to avoid intermixing with existing stock This necessitates the presence of a separate area within the pharmacy w h e r e i n t h e storage and other checking of stocks can be performed This area is called the QUARANTINE AREA This area should be marked and identified adequately to distinguish it from other areas

The area may be marked using different means 1 ) A s m a l l board saying Quarantine on a separate table used exclusively if it is in the middle 2) A board on the wall if the table on which the quarantine stock is placed is against the wall

middot Stock received from wholesalers should be immediately transferred t o t h e Quarantine Area

middot In the Quarantine area the stock may be stored on racks shelves or in cupboards to prevent ingress of moisture dirt and other contaminants

middot Regular stocks from the pharmacy should not be left kept in the quarantine area Special care has to be taken in case of refrigerated medicines supplied by the suppliers so tha t the y do not remain in the quarantine area for long periods of time They should be immediately checked on receipt and transferred to areas for refrigerated storage s o a s to maintain the cold chain bull

Advantages of having a separate Quarantine Area middot Avoids cross mixing of newly arrived stock from existing stock till it is checked middot Lays stress on checking the quality of the stock received middot S to ck checking ensures t hat defective andor expired goods do not enter the storage areas

34

bullbull

bullbull

12 Checks to be carried out on new stock

Unpacking and checking stock

Supplies received should be unpacked and checked in the quarantine area Staff doing the checks should be adequatel y trained in what they have to check when stock arrives

Checking should be seen not simply as counting the units received but as a part of the quality assurance system bullThis should include middot Visually inspecting the packaging middot Checking the integrity of containers middot V erifying the completeness and leg ibility of la b e ls ( a ppr o ve d dr u g name strength any special storage instructions and expiry date)

bull

The expiry dat e should be checked to ensure that there is adequate shelf life remaining

Supplies should be individually checked using a checklist 35

Checklists

36

The wholesaler supplying the product should be notified immediately in case of any discrepancies ( and the details should be recorded in a register) and sent in a written format to the supplier It should include middot Missing boxes or cartons middot O p en tampered boxes or cartons middot Missing supplies middot Differences in the actual quantity and the quantity shown on the packing middot Additional medicines that had not been ordered but have been supplied middot D a m a g e d b r o k e n o r p oor quality medicines middot Any other discrepancies

The purchase invoices are an important aspect to be considered The invoiced documents should be signed and filed for reference as per the Drugs and Cosmetics Act and retained for at least 3years

If the wholesaler supplies medicines as an emergency without a bill or against a delivery challan

middot The supplies should be checked for integrity and inspected for damage middot The details of supplies received should be recorded middot The supplier should be asked t o send the bill as early as possible middot When the bill is received it should be checked against the details recorded and anomalies if any should be reported to the supplier

To keep a track of the received stock maintaining a S t o c k R e c o r d C a r d c a n b e very useful The entries in the stock record card can be made while checking the stock received STOCK BIN in the stores should have Stock record card

Maintaining a stock card for every product may not be very practical for a retail pharmacy however it could be maintained for costly medicines Nowadays it is much more practical and easier to maintain records using computers

The pharmacist should ensure that medicines manufacturedmarketed by a company are received only through an authorized distribution network of that company This is important to prevent spurious and counterfeit drugs from entering the pharmacy

37

2 STORAGE 21 The need for proper storage The storage of medicines and other products is an important requirement of Good Pharmacy Pr actice Appropriate storage of medicines is essential -

middot bullTo ensure that the potency is maintained middot bullTo prevent deteriorationspoilagedegradation middot bullTo ensuremaintain physical integrity

To ascertain that the quality and safety is maintained throughout their shelf life Storage requirements need to be considered on 2 aspects

a) Integrity of medicines Medicines should be stored in such a way so as to maintain their integrity and potency middot Maintain the right temperature required middot Protect from excessive humidity middot Keep medicines away from direct sunlight middot Protect from pests and rodents

b) Physical location middot Should be easy to locate middot Accessible middot Orderlysystematically placed

2 2 D i f f e r e n t p a t t e r n s o f s t o r a g e The pharmacist could follow any of the different patterns of storage The pattern of stora ge should be selected in such a way that it facilitates speedy and efficient dispensing of medicines

The pattern of storage could vary with each pharmacy experience usual practiceroutine of staff and the person-in charge and also depending on space av ailable turnover etc (i) The medicines could be stored c o m p a n y w i s e ie the medicines manufactured by one company should be grouped together and kept in one place Within each company shelfshelves the medicines may be placed in alphabetical order for easy and quick placement and removal Also bottles tubes boxes etc may be segregated within that shelf

38

(ii) The medicines may also be stored in a lphabe t ic al o r de r ie they are placed in order from left to right based on their name The first letter of the name is used to g r o u p t h e m e d i c i n e s t o g e t h e r a n d k e e p t h e m i n o n e l o c a t i o n I n s o m e p h a r m a c i e s a l l t h e strip packing are placed in drawers or boxes in alphabetical order each box or drawer containing strips of one particular alphabet This system ensures that the strips always remain e n c l o s e d i n t h e b o x e s d r a w e r s a n d a r e n o t e x p o s e d t o d u s t T h e d i s a d v a n t a g e i s that it might lead to mix -u p o f strips in the same drawer and it may cause a problem incase of similar looking strips in which case a wrong medicine may be dispensed Secondly cut strips lying around in the drawer may lose their identity if the batch n u m b e r andor expiry date is not seen on the cut portion of the strip

39

(iii) The medicines may be stored according to their therapeutic class ( e g a n t i b i o t i c s anti asthmatics or anti hypertensives) ie the medicines are kept together based on their pharmacological or therapeutic action

(iv) The medicines may be stockedsegregated according to dosage forms eg l i q u i d s (bottles) solid oral dosage forms eye drops rotacaps ointments etc all stored on separate shelves

Always Remember I Storage of prescription medicines should preferably be separate from OTC medicines OTC medicines especially those that a r e a d v e r t i s e d m a y b e d i s p l a y e d f o r c l i e n t s t o select or to ask questions about [OTC-O v e r t h e c o u n t e r ] II Storage according to temperatures is a must no matter which pattern of storage is followed Also within a particular storage area segregated storage may be maintained In a refrigerator for example medicines may be stored in trays racks and the freezer according to the temperature required

40

Whatever pattern of storage is selected all the personnel should ensure that middot The stocks are stored in an orderly manner middot The medicines are kept back in the same place from where they were removed middot All medicines are arranged neatly once in a while

middot The personnel should be careful while storing the medicines middot They should not throw the medicines haphazardly 23 Different means of storage

middot Within each temperature and security zone medicines must be stored so that they are easily accessible and protected against damage

middot Basic means of storage include shelves racks and drawers middot To prevent dust from entering the shelvesracks it is ideal to have glass

shutterssliding glass doors This can however be disadvantageous because accessibilityspeed is hampered in removing a product from the shelf because the glassshuttersliding glass has to be

41

opened m o v e d e v e r y t i m e a p r o d u c t h a s t o b e p i c k e d u p U s e o f a i r c o n d i t i o n e r s f o r t h e p h arm acy with a closed door at the e n t r a n c e o r a n a i r c u r t a i n c a n r e d u c e t h e d u s t problem In such cases the shelvesracks may be left o p e n

bull

middot Direct storage of cartons on the floor should be avoided because besides being an unhealthy practice the contents may also be damaged by moisture bull

middot Store medicines preferably in shelves with glass shutters for visibility middot Closed shelves further prevent dust from going in especially in India where most

pharmacies are located along busy roads middot Some medicines have to be refrigerated or stored in a cool or cold place Having a

refrigerator or two (as per the need of the pharmacy) is essential to store suc h medicines at temperatures mentioned on the label bull

42

Refrigeration middot All cold chain equipment should meet required standards middot Improvement in refrigeration technology has provided frost -free refrigerators

Pharmacists should opt for frost-free refrigerators as they are easy to maintain and protect printed packaging materials Conventional refrigerators may cause water falling from trays below the freezer on medicines stored in the refrigerator thus causing soggy labels

middot bull Frost-free refrigerators also provide separate and large compartments for the freezer portion (required for storing medicines needing sub-z e r o t e m p e r a t u r e ) and the main storage area with separate doors so that opening one door does not disturb the storage temperature in the other compartment

Care should be taken to keep the refrigerator on 24 hours a day It should not be switched off after working hours It is advisable to have an inverter connected to the refrigerator so that the refrigerator re mains working even when there is a power outage

middot The refrigerator door should be closed tightly middot The refrigerator door should not be left open for too long middot Space should be left between medicines stored in a refrigerator to allow air to

circulate middot The ref rigerator should be placed about an arms length away from the wall

This will increase air circulation thus not affecting the cooling within the refrigerator

middot Vaccines should not be stored on refrigerator door shelves as they are exposed to warmer temperatures each time the door is opened Vaccines should always be stored on the middle shelves of the refrigerator

middot Refrigerated medicines should not be left out of the refrigerator for more than a few minutes

43

middot Consumable products like juices energy drinks e t c s h o u l d n o t b e s t o r e d a l o n g with medicines in refrigerators If required they may be kept in a separate refrigerator

middot An adequate number of refrigerators should be planned to store the entire stocks requiring refrigerated storage

middot Adequate procedures should be followed for defrosting cleaning and maintenance of refrigerators

middot Icefreeze packs should be kept in the freezer compartment so that they can be used for transporting cold temperature medicines The packs can be given to clients along with the medicines requiring cold temperature storage so that the temperature is maintained till the client reaches home and can then put the medicines in a refrigerator) Freezer packs can also be used to keep medicines temporarily in case there is a power outage or refrigerator breakdown

Activity

Prepare a SOP (Standard operating procedure chart) for cleaning a refrigerator Discuss it with your staff finalize its maintenance once a month through AMC -A n n u a l Maintenance contract CMC - Comprehensive maintenance contract and put it up on the pharmacy refrigerator Put the Purchase Order details name of manufacturer Phone of Service Engineer and a register to login the Machine service and down timeService reports may be maintained properly

Refrigerator monitoring and maintenance

middot bullIt is important to carry out routine monitoring and maintenance of the refrigerators and to organize an effective repair system

middot bullThe temperature in the refrigerator must be monitored and recorded routinely at least once a day

middot Any breakdown must be reco rded including the period during which the medicines were exposed to uncontrolled temperatures Medicines may then be kept or discarded depending on the problem guidelines or the manufacturers advice

middot Cold chain monitor cards and devices in or on packages that change color or otherwise alert staff to potential damage assist in monitoring (These are likely to be introduced in India soon)

middot It is essential to have a contingency plan in place before a refrigerator breaks down An arrangement can be made to move the contents to a private refrigerator elsewhere in the community or to obtain a regular supply of ice packs until the defect is rectified

Put filled water bottles in the bottom half of the refrigerator door in order to provide cooling in the refri g e r a t o r w h e n t h e r e i s a p o w e r o u t a g e T h i s m i g h t t a k e c a r e o f t h e temperature when there is no current for a couple of hours If the power outage is expected to last for several hours special arrangements such as an inverter UPS have to be made to keep the refrigerator constantly running in the absence of electricity middot Defrost the refrigerator in case of excessive ice formation and preferably at regular

intervals Keep a record of the same

44

2 4 T e m p e r a t u r e c l i m a t i c c o n d i t i o n s

i) Temperature control middot The medicines in a pharmacy need to be stored at appropriate temperatures to

maintain their stability middot An air-conditioned environment where temperature can be controlled is

recommended for pharmacies Air conditioning offers the option of setting the t e m p e rature as per requirements

middot bullIt is ideal to have an air conditioner to maintain the temperature below 25 C as most medicines require storage below this temperature Secondly this temperature is pleasing to both the staff and the visiting customers too

middot In the absence of an air conditioner circulating fans may be used middot This need is felt even more in certain parts of India where temperatures soar above 45

C and some areas where it falls to sub zero temperatures In such cases temperature maintenance is essential to prevent deterioration of medicines due to unnecessary exposure to drastic temperature fluctuations

middot This need is felt even more in certain parts of India where temperatures soar above 45 C and some areas where it falls to sub zero temperat u r e s I n s u c h c a s e s temperature maintenance is essential to prevent deterioration of medicines due to unnecessary exposure to drastic temperature fluctuations

i i ) Humidity or moisture control Moisture or humidity can adversely affect the stability of me dicines such as tablets capsules powders

45

Gelatin capsules become soft and swell on absorption of moisture The drug content of tablets may undergo surface hydrolysis The presence of moisture may encourage the growth of microbes It is therefore essential to control humidity

To reduce the effect of humidity the following suggestions may be followed -middot Open the windows to allow air circulation Use a fan to circulate fresh (outside) air middot In humid climate a dehumidifier is useful for preventing mo i s t u r e d a m a g e ( i n t h e absence of an air conditioner) middot For bulk containers of tabletscapsules do not keep the container open for a long time and replace the lid or closure immediately after taking out the required number of medicines for dispensing middot Do not allow the medicines to touch the floor or the walls The walls may be damp and may cause moisture absorption damaging the product

middot Calibrated thermometers and manometers can be used to detect temperature and humidity in the pharmacy

middot Periodici t y of checking the temperature should be fixed middot The climatic conditions should be recorded and documented middot Temperature charts should be available for ready reference

Documentation is one of the core activities for achieving and maintaining quality It is one of the most essential components of validation Temperatures in various areas

46

including refrigerators should be recorded at a predetermined periodicity usually daily at the hottest time of the day and such documents should be preserved i i i ) Storage conditions A number of storage conditions are mentioned on the labels of medicinal products These conditions have to be properly interpreted and appropriately complied with

According to the Drugs and Cosmetics Rules 1945

1 The term cool place means a place having a temperature between 10 C and 25 C

2 The term cold place means a place having a temperature not exceeding 8 C In case of storage conditions for specific products please refer to Schedule P The Drugs and Cosmetic Rules 1 9 4 5

The Indian Pharmacopoeia specifies the following storage conditions -

Wherever the condition for storage is not specified medicines may be stored under normal temperature In a country like India however where normal temperatures soar to h i gh temperatures it is recommended that medicines be stored in a cool place

Activity Prepare a list of the storage requirements mentioned on the label of about 20 products in your pharmacy and check if the temperature is maintained

47

25 Special Storage o f s u p p l i e s If the product has no special instructions normal storage conditions apply This means storage in dry clean w e l l -ventilated premises at temperatures of +15 C to +25 C or depending on the climate up to +30 C (WHO1990) Storage instructions are product specific Different brands of the same generic drug may have different storage requirements as they may have different packaging or formulations It is essential to follow the product manufacturers storage instructions to the maximum extent possible Less stable medicines must be stored in specific conditions to maintain their quality or potency

The following products require special storage facilities

middot Products that must be kept frozen (usually vaccines and sera) middot Products sensitive to h eat an d r e q uir in g r e f r ig e r a tio n ( +2 C to +8 C) middot Products that have reduced shelf life at uncontrolled room temperature and need

mechanical ventilation or air conditioning middot Flammable products that require separate fireproof premises middot Products prone to theft o r m i s u s e

Products needing storage in a controlled environment -

The usable shelf life of the following products may be reduced if stored at uncontrolled humidity or at room temperature in hot climates -

middot Some injectables (eg adrenaline) Most injectable preparations are less stable than solid oral forms (tablets and capsules) Injectable preparations in solution are particularly unstable Many injections must be protected from light as well as heat

middot Intravenous fluids (particularly if packed in p lastic containers) middot Some suppositories pessaries creams and ointments These products may melt at

temperatures greater than 30 C Once this happens it is not advisable to use them because the active ingredient in the formula may get unevenly distributed

middot Products containing rubber latex cellulose or some plastics Condoms most sterile disposable medical devices and surgical products such as syringes needles and catheters require protection from excessive humidity and strong light and heat Any o f these conditions may make products brittle stained amp unusable Sterility cannot be assumed if packaging is damaged

In hot climates these products should be stored in the coolest place possible preferably with air conditioning or air circulation fans

48

Products needing freezing or refrigeration-middot Vaccines blood products and many other medicines lose potency if kept even for a

brief period at temperatures outside the recommended range For these products the cold chain must be maintained at every stage of the distribution system

middot Freezing is as damaging as high temperatures for some products including injectable contraceptives ergometrine insulin adrenaline and the DPT DT TT and Hepatitis B vaccines Such products therefore sho uld not be allowed to freeze (not be kept in the freezer compartment)

middot Short periods at room temperature (during transportation or local distribution for instance) may be acceptable for many products (such as ergometrine a n d i n s u l i n ) e v e n t h o u g h s u c h e x posure can to some extent reduce shelf life Other items such as vaccines should always be transported in cold boxes

Storage of insulin injections-

middot Insulin should always be stored in a refrigerator at the recommended temperature of 2 -8 C

middot Insulin should not be kept in the freezer compartment of the refrigerator middot Insulin should ideally be stored horizontally middot It should not be exposed to sunlight or excessive heat middot Insulin suspensions should not be used if the suspension cannot be properly

resuspended due to cake or clump formationbull

Controlled drugs -Narcotics (for example Pethidine injection morphine preparations) and other specified drugs that may be abused are governed by special legislation and regulations The following security measures are suggested in the pharmacy -middot A safe or reinforced double locked cabinet fitted with a light (preferably with a red

bulb) that comes on when the door is opened

49

middot A special register recording details of each receipt or issue with 2 signatures physi cal counting of medicines after each entry and signatures at handover takeover

middot Independent audit (by supervisors and drug inspectors)

Products prone to theft abuse or misuse -

Some medicinesproducts are particularly prone to theft abuse or misuse These include expensive medicines (eg insulin) certain antibiotics and products prone to abuse or misuse like psychotropics etc

Such medicinesproducts should be stored adequately They require stricter record keeping and more frequent stock taki ng than others Periodic audits should be carried out to check for consumption against actual recorded use (registers prescription records stock records etc) to expose any theft or misuse bull26 Storage and stability of medicines Medicines are not stab le indefinitely They are stable for a specific period of time sometimes for a brief period Poor storage conditions accelerate the drug degradation (decomposition) Temperature light and moisture are the most important contributing factors for drug instability It is important to identify and be aware of the potential for instability There is a need to comply with storage requirements to ensure quality medicines for patients It is also important to offer advice to patients too about appropriate storage o f medicines at home The dispensing label should state the storage condition required and be backed up by a verbal reminder especially where special storage is required bull

50

In case stability and storage problems are seen with formulations they should be reported immediately to the representative of the manufacturer and taken out of circulation till the stability problems have been resolved

The pharmacist can easily detect stability problems when products show change in appearance color odor settling of the product contents breaking of emulsions melting of creams oozing of contents from the containers and any such physical changes

3 STOCK CONTROL AND EXPIRY MONITORING 3 1 S t o c k C o n t r o l For economic reasons pharmacists do not like to have stock on their shelves for long periods of time The aim should always be to keep stock at a level that will just meet demand Normally most manufactured medicines have a long shelf life Even then it is essential that there is efficient stock rot ation so that the older stock is used first It is also a good practice to check the expiry date as an integral part of the dispensing process When short shelf life products are involved stock levels may have to be modified to prevent medicines regularl y expiring on the shelves

32 Stock rotation and expiry monitoring In order to avoid accumulation of expired and obsolete stock medicines should be stored and issued according to the following guidelines -middot The stock control system must record the ex p i r y d a t e a n d t h e d a t e o f r e c e i p t middot Stock must be stored so that earliest expiring batches are picked and issued first middot The First In First Out (FIFO) system - In this system the stock which is received

first is sold first This system however may not be useful for pharmacies because most of the stocks carry an expiry date For pharmacies the FEFO system is more practical

51

middot The First Expiry First Out (FEFO) system - In this system the stock having an earlier expiry is sold first The stock with longer shelf life should be placed farthest to the back (or at the bottom in case o f sta c k e d b oxe s) T h is is pa r tic u la r ly impor ta n t with products that have short shelf lives such as vaccines some vitamins antibiotics etc and reduces losses due to expiry

middot E x p i r y dates should be noted on the stock record upon receipt Stock nearing expiry should not be accepted unless it can be used before expiry

Computerization and expiry monitoring In the pharmacy computerization facilitates both checking stocks and expiry mo nitoring and helps-bullbullKeeping a check on products nearing expiry bullbullKeeping a check on non- moving and slow moving products bullbullTo facilitate the removal of medicines nearing expiry from shelves in time to send them back to the wholesaler or supplier

Periodic checking for expiry The expiry date for medicinal products is a critical aspect in pharmaceutical dispensing and due importance should be given to it Periodic checking for expiry of medicines will ensure that the patient will never receive products that have crossed their expiry date During periodical checking of expiry the personnel involved should remove medicines that are nearing expiry bullbullIn -house threshold periods should be set and followed for retrieval of such medicines from the shelves bullbullSuch medicines should be stored separately These should either be dispensed immediately (thus ensuring that they are used before the expiry date) o r t h e y s h o u l d b e returned to the suppliers bullbullA separate area should be designated (cupboard or shelf)marked[FROZEN ZONE] which is adequately marked EXPIRED GOODS- NOT FOR SALE to store all expired stocks FROZEN ZONE

52

Remember Expired medicines are a NATIONAL WASTE So stock only what you can sell Avoid expiries save precious medicines for the nation

Treatment and disposing of expired medicines bullbullProcedures need to be in place for the treatment of expired medicines bullbullThe expired medicines need to be collected and be sent back to the supplier or company for appropriate disposal bullbullRecords must be maintained for expired medicines and how they are disposed off bullbullIn case of medicines that are not returnable to suppliers procedures for disposal need to be followed by the pharmacy in conjunction with the FDA The following procedure can be followed if medicines cannot be returned to suppliers ( T h e b a s i c p h i l o s o p h y of appropriate disposal is to prevent their re- circulation and use) bullbullC u t t h e c o n t ainer in such a manner that the label is also cut In case of tablets and c a p s u l e s d e s t r o y them by disposing them in a bucket of water bullbullUse landfill procedures (deep burial into the ground as per stipulations of Medical Waste Disposal Act prevalent in the respective state) bullbullPour the liquids into the sink and wash away with sufficient quantity of water bullbullKeep a record of such disposal with full details of medicines destroyed Although these measures are usually adopted care has to be taken with such tr e a t m e n t a s studies have shown that flushing of medicines has resulted in tracessmall quantities of medicines being found in waterways and groundwater having potential health and environmental effects

4 O T H E R A S P E C T S 41 Design of storage areas The following important factors need to be considered in design of storage areas -middot The retail outlets in hot areas in summers should be air-conditioned Similarly in

a r e a s o f e x t r e m e c o l d t h e p r e m i s e s w o u l d r e q u i r e w a r m i n g e s p e c i a l l y i n w i n t e r s t o maintain cool temperatures The placement of air -conditioners and heating devices should be such that medicines are not directly exposed to the cold or heat

middot Due consideration should be given to storage requirements of formulations while designing shelves and cupboards in retail outlets Sufficient shelf height should be provided so that all liquid products can be stored vertically As far as possible the shelves should be covered with glass panels to protect medicines from dust and p r e v e n t r a p i d f l u c t u a t i o n s i n temperature

middot Medicines should be stored according to the storage instructions on the labels bullIt is ideal to have a door at the pharmacy entrance to prevent dust from coming in as well as reduceprevent cooled air from going out This may not however be considered feasiblepracticable by many pharmacy owners for fear that clients may not enter the pharmacy because the door may act as a barrier An air curtain is a good alternative to a door

middot There should be minimal direct sunlight falling on the products Particular consideration should be given to premises directly facing the sun

middot bullThe arrangement of lighting in the interior of the premises should also be in a manner that the lights are not focused on the products It has been shown that light causes not only chemical damage but also can catalyze physical changes like moisture uptak e by the products Care should be taken to ensure that only diffused light falls on them

53

middot As far as possible provision should be made for a temperature and humidity indicator device in a pharmacy These devices are now easily available

middot Stability studies o f m e d i c i n e s p a c k e d i n b l i s t e r s h a v e r e v e a l e d t h a t i f t h e s e a r e exposed to light they tend to absorb moisture It is therefore necessary to store them in suitable cartons so that the blisters are not exposed to light Pharmacists should do this even if the manufacturer has not provided cartons

middot Light and temperature sensitive products should not be stored on counters where the light is intense or direct and there is no protection from temperature and humidity

42 Cleaning and maintenance i) Cleaning of storage areas

The storage areas of the pharmacy should be cleaned periodically and cleanliness should be maintained at all times The Standard Operating Procedure for cleaning should be designed and followed accordingly Schedules for cleanups should be laid down and adequate cleaning equipment should be made available

Tips for maintaining cleanliness middot Provide clean pieces of cloth for wiping at various locations in the pharmacy

Replace with clean cloth at regular intervals middot Keep separate pieces of cloth for floors shelves and medicines middot Use a disinfectant andor soap solution to clean floors middot Ensure removal of dust and prevent accumulation of dirt middot Ensure removal of cobwebs middot Use a vacuum cleaner for cleaning areas not easily reachable middot T a k e c a r e t h at breakages are handled and cleared effectively middot Observe the factors leading to waste generation in the pharmacy and take appropriate

measures to tackle the problem middot Record all cleaning procedures performed and maintain all the documents required

For ex a m p l e -bullbullThe floor of the pharmacy may be swept with a broom and swabbed with soap water every morning bullbullThe floor may be swabbed with a disinfectant every week bullbullThe entire premises including shelves and cupboards may be cleaned with a cloth (to remove dust and to check for medicines approaching expiry date or expired medicines) every three months bullbullAll the steps followed should be r e c o r d e d

The floor shelves drawers have to be cleaned and a check should be kept on dust cobwebs spillages due to breakage etc It is therefore essential to have SOPs for cleaning laying down cleaning frequencies allotting responsibilities and maintaining a daily record in the logbook to document all these activities

54

While cleaning dust settled on dosage forms like bottles tubes etc should be removed Before dispensing the products should also be wiped to remove any dust settled during storage

For refrigerators bullbullDefrosting and cleaning should be done at regular intervals bullbullSwitch off the refrigerator while cleaning bullbullCleaning should be done quickly and stocks put back immediately

i i ) Pest control Pests are a serious problem in India where insects reptiles and rodents (eg cockroaches l i z a r d s r a t s s i l v e r f i s h (Deemak - in Hindi ) etc) may find access to the pharmacy storage areas Insects like ants and borer ants may often attack wood in the pharmacy causing d am ag e to shelves cupboardsPest c ontr o l in a p h a r m a c y c a n b e a d i f f i c u l t t a s k b u t t o avoid possible contamination and physical damage to stock it is necessary to keep pests out of the pharmacy premisesPest control measures should be implemented with proper p r e c a u t i o n s t a k i n g u t m o s t c a r e t o a v o i d contamination of medicines

55

Th e following pest control measures c a n be ta ke n f r om tim e to tim e -bullbullRat bait and traps can be placed at various locations bullbullInsecticutors can be used on a permanent basis bullbullInsecticidal sprays and repellants can be used from time to time

i i i ) Fire precautions

Combustible trash such as cartons boxes and other packing waste must not be allowed to accumulate in the store Waste should be deposited in appropriate waste bins and be d i s p o s e d o f f o n a d a i l y b a s i s

F i re detection and fire fighting equipment must be maintained and regularly inspected The pharmacy personnel should receive adequate training in fire fighting techniques and emergency actionFire prevention measures should include a prominently displayed ldquoNoSmokingrdquo sign careful handling and disposal of combustible waste materials and checking of electrical connections at regular intervals

iv) Security middot Doors shutters of the pharmacy should be strong and be fitted with secure locks middot Counters should be designed so that unauthorized personnelclients do not have

access to areas where prescription medicines are stored Access to such areas should be restricted to the pharmacy staff

middot All the pharmacy staff handling supplies should be accountable for their ac t i o n s

56

middot bullSpecial care must be taken in case of Schedule X and manufactured drugs (under NDPS Act) Such medicines should be kept under lock and key and the key should be kept with the Chief Pharmacist or i n h i s a b s e n c e t h e s e n i o r p h a r m a c i s t

v) Breakagespillage and damaged product Products that have been damagedspoiled during storage and handling spillages and broken glassware should be disposed off according to procedures laid down by the pharmacy Broken and damaged products s h o u l d b e p l a c e d i n a segregated area to be returned to the supplier

vi) Inspection Senior staff should inspect all pharmacy areas regularly The shelves and drawers should b e c h e c k e d d a i l y f o r signs of pests and dust Ceiling and walls should be checked for dirt and cobwebs Stock should be checked on a regular basis for deterioration due to climatic conditions

43 Product recalls Products found to be defective should be quickly recalled (withdrawn from the market) The instructions are generally issued either by the manufacturer or the regulatory agency The level of recall is determined by both the degree of risk and the extent of distribution of the product and in India is mainly directed at the distribution chain

On receiving the details of the defective substandard spurious batchbatches of a medicine to be recalled from the manufacturer or the stockist or the FDA the pharmacy should immediately check if the particular b a t c h i s i n s t o c k a n d i f s o s u s p e n d i t s s a l e immediately

Similarly if the regulatory authority in the country bans a particular medicine or FDC the pharmacy should immediately check and remove all the different brands of that particular medicine under consideration

The details of medicines and their batches to be recalled should be available in the q u a r a n t i n e a r e a w h e r e stocks are received and checked This is to ensure that such medicines do not come into the pharmacy

middot The pharmacy should develop SOPs for recall of medicines middot The pharmacy staff should be immediately informed about such medicines and

the details should be displayed in writing in a prominent place in the pharmacy middot Rapid action helps avoid unnecessary exposure to such medicines once the

problem has been d e t e c t e d middot The progress of the recall procedure in the pharmacy should be monitored every

few days to ensure complete compliance middot All stocks of the recalled products should be stored separately from the saleable

stock These can be stored in the expiry cupboard segregated from the expired goods and be appropriately labeled ldquoRecal l e d G o o d s - Not for Salerdquo

The supplier should be notified and asked to replace defective products middot All the details of the procedures followed should be duly recorded in a Recall

Register maintained specially for the purpose The register should include d etails such as -middot Date of the recall middot Nam e of the product

57

bullbull

middot Details of the product (name of manufacturer batch number expiry date) middot Nu m b er of units purchased sold a n d sto c k in ha nd middot Reason for recall middot Nam e of the supplier to whom produc ts w e r e returned along with the date and quantity middot Name and signature of the designated personnel carrying out the recall procedure and recording details middot Name and signature of the chief pharmacist verifying the recall procedures and recording details 4 4 Returned medicines

Medicines may be returned to the pharmacy by clients due to the following reasons -bull

bullbull Unused medicines bullbull Course not completed bullbull Therapy changed by doctor bullbull Side effects experienced by patient bull

bullbull DamagedDefective medicines bullbull Missing or defaced label bullbull Missing tablets in a stripblister bullbull Leakage in bottles bullbull Leakage in strips bull

bullbull Expired medicines

Appropriate SOPs should be framed and followed for their acceptancerefusal and disposal middot bull For unused medicines returned by clients the p harmacy personnel should verify

that these were purchased from their pharmacy They should then be checked for integrity of the packing the dosage form and the expiry date and verified with the client whether they were stored in appropriate conditions This again is at the discretion of each pharmacy

middot The damageddefective medicines returned to the pharmacy should be taken back and stored separately Existing stock of the same product should be checked for similar defects

middot Expired medicines should be accepted from clients at the discretion of the pharmacist and be immediately shifted to the expired goods cupboard These can be stored segregated from the pharmacys own expired goods and be appropriately labelled ldquoExpired Goods returned by clients- Not For Salerdquo

It is advisable not to accept returned medicines requiring cold chain storage (refrigeration) because it cannot be ensured that the cold chain was maintained when the medicines were in the hands of the patientclient middot Appropriate adjustments in t he stocks should be made for medicines

returnedexchanged to update the inventory middot The medicines should then be returned to the respective shelves middot A lsquoReturned Goodsrsquo register needs to be maintained to record all details of returned

medicines

R egister should include such details as-

58

middot N a m e o f t h e p a t i e n t middot Nam e of the product and quantity r e tu r n e d middot Product details such as the batch number and expiry date middot Condition in which received middot Reason for returning products middot Compensatory measures taken wi t h r e s p e c t t o c l i e n t middot Action taken with respect to product middot Name and signature of the personnel accepting the returned medicines and recording details middot Name and signature of the chief pharmacist verifying the recorded details

What the pharmacist would have learnt from this module The storage of medicines is a critical factor in the distribution cycle bullbull Stocks received by the pharmacy should be quarantined in a separate area and necessary checks s h o u ld be performed to ascertain the qua lity a nd quantity of stocks received bullbull Whatever pattern and means of storage used the products should be stored so as to maintain their potency and integrity bullbull Storage conditions should be monitored and maintained on a regular basis bullbull Optimum stock levels should be maintained and regularly monitored for expiry bullbull The design of storage areas should facilitate appropriate storage of medicines bullbull Cleanliness should be maintained in the pharmacy bullbull Adequate measures should be taken in case of returned medicines and recalled products

Optimum storage of medicines is mandatory whether at the distribution stage at the pharmacy or ultimately within the homes of patients The pharmacist has an important r o l e t o p l a y i n t h e s t o r a g e o f m e d i c i n e s i n m a i n t a i n i n g d r u g p o t ency and efficacy and thus facilitating optimum therapeutic benefits Good Pharmacy Practice - IPA -CDSCO - WHO Appendix I Quality Assurance Templates of letters for use if found not of Standard Quality [Frozen and expired goods ]

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated To Name of the Supplier with address

Sub Not of Standard Quality GoMP-Supply of Drugs and medicines-(Codename) Return of Stocks to the Suppliers-reg(New drug policy 2009) Previous letterinvoice ref Sl No Drug Code Drug name

Manufacturing date Expiry date

Supplier address

B a t c h n o

The above items of PO nodated was drawn by the Drug Inspector (Place) on (______________date) as a statutory sampling and declared ldquoNot of Standard

59

Qualityrdquo on -(______________date) by the Government Analyst for the following reasons

- ldquoThe product sample do not confirm to IP specification for (Drug codename with respect to the content of drugrdquo

- ldquoThe product has already been blacklisted by TNMSC on -(______________date) for the failure of (quantity) of batches of drug codenamerdquo

As per the clause of the te nde r d oc um e nt ldquo I f the sa mple s d o not c onf o r m to statutory standardsthe tenderer will be liable for relevant action under the existing laws and the entire stock in such batch should be taken back by the tenderer within a period of 30 days o f t h e r e c e i p t o f t h e l e t t e r f r o m t h e v e n u e

The stock shall be taken back at the expenses of the tendererthe Procurement Authority have the right to destroy such Not of Standard Quality if the tenderer does not take back the goods within the stipulated time

The Procuring Authority will arrange to destroy the Not of Standard Quality drugs within 90 days after the expiry of 30 days mentioned above without further notice and shall also collect demurrage charges calculated at the rate of 2 per week on the value of the drugs rejected till such destructionrdquo

Hence we regret to inform you that you will have to take back the stocks available of the abovesaid batch at your own cost from the drug stores where you have supplied the above batch

Kindly acknowledge the receipt of this reference at once

P r o c u r e m e n t A u t h o r i t y Seal and Stamp

Copy to Ref No dated

1 ) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated13082010

To

Sub Frozen Drugs-ordered to return to the Suppliers-reg(New drug policy 2009) Previous letterinvoice ref

The following products which were earlier frozen have now been ordered to return to suppliers directly with permission from the State drug Authority In this regard the suppliers have been instructed to take back their failed batch from the drug store of the stores Hence you are now instructed to return the following failed batches to the suppliers by obtaining proper authorization letter and acknowledgements from them

60

Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

Kindly acknowledge the receipt of this reference at once

Procurement Authority Seal and Stamp

Copy to

Ref No dated 2) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated14092010

To

Sub Frozen Drugs-ordered to return to the Suppliers- for issue of gate pass after verification reg(New drug policy 2009) Previous letterinvoice ref

The following products which were earlier frozen have now been released Hence they may be issued Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

Kindly acknowledge the receipt of this reference at once

Procurement Authority Seal and Stamp

Copy to

61

Ref No dated 3) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated

To

Sub Stop instruction-reg(New drug policy 2009) Previous letterinvoice ref

Until further instructions stop issue all the batches of the following item Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

You must intimate the available stock in the stores of the said batch Number to the Procurement Authority immediately Also retrieve quantity if already issued

Procurement Authority Seal and Stamp

Copy to

Ref No dated 4) HOD Procurement Office of

62

Appendix II Material handling in drug stores

Rack approx rates and dimensions

S No

Item Description UOM Approx Rate

1 MEDIUM DUTY RACK SIZE 2900 H X 3090 W X 800 D IN MM (AS PER SPECIFICATION)

Each 2499800

2 MEDIUM DUTY RACK ADD ON UNIT FOR SIZE OF SR NO2

Each 2243100

To locate a Box no 3 Rack no 14 in row3

SAMPLE OF RACK no Bin numbering -------------- S a y R K 1 4 R o w 3 B o x 1 6

SAMPLE LAYOUT of RACKS in a Drug Stores

63

Sample of another warehouse of distribution warehouse system

64

65

Slotted Angle racks with bin cards

66

Plastic Pallets

Plastic pallets ar e l i g h t w e i g h t l o w- c ost and exceed industry standards for strength and durability

NOTE A pallet has bottom deckboards (see sketch) A skid does not have bottom

67

deckboards

Battery Operated Stacker

Electric Stacker Ehh (Manual Push Type) - Manual drive - Lifting electrically with Battery 12 V 88 Ah - For loading and un-loading of trucks - Battery and loading device built - in - Battery charge gauge and charging current gauge Simple and Easy Operation - Lifting and Lowering electrically direct on steering arm - Pulling and pushing through steering arm - Electrically operated relief valve on hydraulic aggregate Safe Operation - Emergency Off Switch - Constant lowering speed - Protection through lowering brake valve - Overload protection through overload brake valve - Load chains covered preventing pinching threat - Electrically interlocking during loading process - Secured battery compartment opens upwardly - Stable buffering of the steering arm in upright position - In accordance with EWG Guidelines 89 240 - In accordance with VBG 12b Prevention of Accidents

Pallet Truck [ Top ]

68

----------------------------------------------------------------------------------------------------------------------------

For Transport Of All Goods On Pallets Safe and Easy Operation - through single hand operation Lifting moving

lowering with steering handle - neutral position of the hydraulic possible - overload pressure relief valve Long Service Life - robust co n s t r u c t i o n

- special hardened axles - hardened chromium plated ram - maintenance free Easy Maneuverability - through rubber steering rollers - nylon fork rollers

A h a n d t r o l l e y

69

Trolley with plastic bins for several items del ivery

70

Digital Weighing balances

Balances amp Scales EF Seriers Precision Electronic Balance

71

1

Ice lined Refrigerators

600 litres refrigrator

72

Walk in cooler

vacuum cleaner

73

( b ) Cost of the articles under the various Heads Received during the year (c) Cost of various articles written off during the year under review ( d ) Cost of the articles on the last day of the year or on the firs t d a y o f t h e

financial year following

19

Annexure A WardSection Indent Register No Issued on

Name of institution Page Folio No

Serial no Name of Article Quantity in Stock

Quantity required

Prepared by Approved by Recd by Note-Indenting Officer to sign and affix seal with name and

designation below the last item to avoid additions in one strokeno issues to be made by storesif Issue vouchers of

previous Indent has not been returned back by the WardSection

20

Annexure B Issue Voucher No (printed number)

Supplied to Wardsection Date

Indent no

Serial no Name of Article Quantity in Stock

Quantity required SB No

Stores-in MO Resident in Sign of charge charge WardSection

NurseCompounder Prepared by Recd Approved by by

Note-Indenting Officer to sign and affix seal with name and designation below the last item to avoid additions in one strokeno issues to be made by storesif Issue vouchers of previous Indent has not been

returned back 1st copy-Stores 2nd copy -Wardsection3rd copy-Tobe reurned to sores with Stock book entries

21

Annexure C

STOCK REGISTER FOR DEAD STOCKS

SERIAL NO DATE OF RECEIPT

Article with description

No of pieces Cost Details of

Bill Signature No Disposed

Date of disposal

Manner of Disposal

with Authority

Value realised Signature

1 2 3 4 5 6 7 8 9 10 11 12

P r e p a r e d B y C h e c k e d b y A p p r o v e d b y

Date Designation Name of Institution

22

Annexure D

STOCK REGISTER FOR EXPENDABLE ITEMS Name of article

Date

From where

received with cost

Quantity Signature To whom issued Quantity Balance Signature

1 2 3 4 5 6 7 8

23

Annexure E

Receipt amp Issue Register for WARDSSECTIONS (one or more pages as per requiremnt for each medicine)

NAME OF MEDICINE RECEIPT ISSUE

DATE Quantity In Stock

Date of

Issue

Issued toMention Bed no amp

quantity (in bracket) (For

Outdoor cases give Regd No)

Balance Signature

24

Annexure -F

OUTDOOR FREE MEDICINE SLIP In Duplicate

Name of Patient Registered No Date

Sr no Name of Medicine Quantity

Seal amp sign of doctor

25

Annexure-G

TREATMENT CARD

WARD NO

NAME OF PATIENT BED NO DATE amp TIME OF ADMISSION DATE amp TIME OF DISCHARGE

DATE MEDICINES PRESCRIBED SIGNATURE

26

ANNEXURE -H

PROFORMA FOR BREAKAGE amp LOSS

NAME OF OFFICEINSTITUTION DATE PLACE

SRNO NAME amp

DESCRIPTION OF ARTICLE

COST DATE OF PURCHASE

REASON CAUSE OF BREAKAGE

RECOMMENDATION OF INVESTIGATING AUTHORITY

Signature

Orders of the Competent Authority

Signature

27

Annexure ndash I Loss- Procedure for Reporting

1 The exact nature of the defalcation 2 The full extent of loss 3 The actual period covered by the defalcation 4 The defects in the negle c t o f r u le s by w hic h the loss was rendered possible

and circumstances which facilitated the defalcation 5 The names of the officials held personally or technically directly or

indirectly and wholly or partially responsible for the irregularity c o m m i t t e d i n t h e c a s e

6 Whether the c a s e a s b e e n J u d i c i a l l y t r i e d i n a c o u r t o r n o t i f s o c o p i e s ( i n duplicate) of the Judgment may please be furnished Copy of police report may also be furnished

7 The remedial measures adopted as safeguards against the losses hereafter 8 The prospects of re covery of the loss and he action taken to effect

recovery together with the amount recovered 9 Head of Account to which the Loss is debitable may be informed

Signature of Head of Office with seal

NoteA copy of this report is to be sent to AGMPThis is as per M P Finance Code Vol I

28

STORAGE AND STOCK MANAGEMENT

29

Foreword

The New Drug Policy 2009 is being implemented in the State of Madhya Pradesh

In order to have a proper procedure for Storage maintenance and expiry management of the drugs it is necessary to follow Good Storage Practices with Standard Modules for pharmacistStore keepers

Proper guidelines on Storage Practices can lead to better Stores and inventory upkeep with medicines being properly stored in racks with proper cleanliness and hygiene

This is a step towards storage maintenance and expiry management at the various stores in the state Looking forward to see that the heads of all health facilities take benefit from this module

D ir e c t o r M e d i c a l S e r v i c e s

30

INDEX

Sr No P a r t i c u l a r s P a g e

1 S T O R A G E A N D S T O C K M A N A G E M E N T 4

1 Quarantine and checking of stocks 11 Quarantine area 12 Checks to be carried out on new stocks

2 S t o r a g e 21 Need for proper storage 22 Different patterns of storage 23 Different means of storage 24 Temperatureclimatic conditions 25 Special storage of supplies 26 Storage and stability of medicines

3 Stock Control and Expiry Monitoring 31 Stock control 32 Stock rotation and expi r y m o n i t o r i n g

4 Other aspects of storage 41 Design of a storage area 42 Cleaning and maintenance 43 Product recalls 44 Returned goods

2 A p p e n d i x 1 Templates of letters for use if found not of Standard Quality [Frozen and expired goods ]

Frozen Drugs-ordered to return to the Suppliers-reg(New drug policy 2009)

Frozen Drugs-ordered to return to the Suppliers- for issue of gate pass after verification reg(New drug policy 2009) Stop instruction-reg(New drug policy

2009) Appendix II Material handling in drug stores

31

3 PROCUREMENT ndash Government Order Relating to

the Management of Stores

(Reproduced for reference material on basic

procedure in decentralized system followed by

Health facilities in 1977)

54

F L O W C H A R T S f o r a BI R D S E Y E V I E W o f

P R O C U R E M E N T

5 5

ACQUISITION OF STORES 6 1

PLACING OF ORDERS 6 2

RECEIPT OF STORES 6 2

CUSTODY 6 3

ISSUE OF STORES Maintenance of Stock Books

6 3

PROCEDURE OF INDENTING FOR WARD amp OTHER SECTIONS OF THE INSTITUTION

6 4

HOW OFTEN TO INDENT 6 5

EMERGENT INDENT 6 5

HOW TO INDENT 6 5

KEEPING OF RECORDS IN WARDS A N D S E C T I O N S

6 6

ACCOUNTABILITY OF DRUGS BROUGHT BY THE PATIENT OR RECEIVED IN DON A T I O N BY T H E WARDSECTION _IN - CHARGE

6 7

RESPONSIBILITY OF STORES AT VARIOUS LEVELS

6 7

DISTRIBUTION OF MEDICINES FROM OUTDOOR DEPARTMENT

6 7

LOSS BREAKAGE DAMAGE ETC 6 8

PROCEDURE FOR WRITING OFF STORES 6 9

DISPOSAL OF WRITTEN OFF ARTICLES 7 1

FORMATS TO BE USED 7 3 - 81

32

STORAGE AND STOCK MANAGEMENT The expiry periods of pharmaceutical products have meaning only if the products are stored under proper conditions otherwise products are likely to lose their potency before the actual date of expiry

A pharmacist is a vital link in the distribution chain for pharmaceutical products The medicinal products remain for a long period during the distribution cycle at the wholesaler and at retail pharmacies It is therefore very important to maintain proper storage conditions in these units

Every community pharmacy however large or s mall needs to store and manage its medicine stocks effectively There must be systems to ensure

middot bullbull Secure storage middot bullbull Clean and correct environmental conditions during storage middot bullbull Accurate and effective record keeping middot bullbull Effective stock rotation and expiry monitoring middot bullbull Effective fire and theft prevention middot bullbull Effective rodent pest control

For easier un derstanding this module has been divided into the following sections

1 Quarantine and checking of stocks 11 Quarantine area 12 Checks to be carried out on new stocks

2 S t o r a g e 21 Need for proper storage 22 Different patterns of storage 23 Different means of storage 24 Temperatureclimatic conditions 25 Special storage of supplies 26 Storage and stability of medicines

3 Stock Control and Expiry Monitoring 31 Stock control 3 2 S t o c k r o t a t i o n a n d e x p i r y m o n i t o r i n g

4 Other aspects of s t o r a g e 41 Design of a storage area 42 Cleaning and maintenance 43 Product recalls 44 Returned goods

33

1 QUARANTINE AND CHECKING OF STOCKS

11 Quarantine Area D r u g S t o r e pharmacies receive stoc k s f r o m su pplie r s a c c or d ing to pur c h a se o r d e r s T he stock that is received must be visually checked for quality and quantity The stocks must be kept in a separate area until the checking is done to avoid intermixing with existing stock This necessitates the presence of a separate area within the pharmacy w h e r e i n t h e storage and other checking of stocks can be performed This area is called the QUARANTINE AREA This area should be marked and identified adequately to distinguish it from other areas

The area may be marked using different means 1 ) A s m a l l board saying Quarantine on a separate table used exclusively if it is in the middle 2) A board on the wall if the table on which the quarantine stock is placed is against the wall

middot Stock received from wholesalers should be immediately transferred t o t h e Quarantine Area

middot In the Quarantine area the stock may be stored on racks shelves or in cupboards to prevent ingress of moisture dirt and other contaminants

middot Regular stocks from the pharmacy should not be left kept in the quarantine area Special care has to be taken in case of refrigerated medicines supplied by the suppliers so tha t the y do not remain in the quarantine area for long periods of time They should be immediately checked on receipt and transferred to areas for refrigerated storage s o a s to maintain the cold chain bull

Advantages of having a separate Quarantine Area middot Avoids cross mixing of newly arrived stock from existing stock till it is checked middot Lays stress on checking the quality of the stock received middot S to ck checking ensures t hat defective andor expired goods do not enter the storage areas

34

bullbull

bullbull

12 Checks to be carried out on new stock

Unpacking and checking stock

Supplies received should be unpacked and checked in the quarantine area Staff doing the checks should be adequatel y trained in what they have to check when stock arrives

Checking should be seen not simply as counting the units received but as a part of the quality assurance system bullThis should include middot Visually inspecting the packaging middot Checking the integrity of containers middot V erifying the completeness and leg ibility of la b e ls ( a ppr o ve d dr u g name strength any special storage instructions and expiry date)

bull

The expiry dat e should be checked to ensure that there is adequate shelf life remaining

Supplies should be individually checked using a checklist 35

Checklists

36

The wholesaler supplying the product should be notified immediately in case of any discrepancies ( and the details should be recorded in a register) and sent in a written format to the supplier It should include middot Missing boxes or cartons middot O p en tampered boxes or cartons middot Missing supplies middot Differences in the actual quantity and the quantity shown on the packing middot Additional medicines that had not been ordered but have been supplied middot D a m a g e d b r o k e n o r p oor quality medicines middot Any other discrepancies

The purchase invoices are an important aspect to be considered The invoiced documents should be signed and filed for reference as per the Drugs and Cosmetics Act and retained for at least 3years

If the wholesaler supplies medicines as an emergency without a bill or against a delivery challan

middot The supplies should be checked for integrity and inspected for damage middot The details of supplies received should be recorded middot The supplier should be asked t o send the bill as early as possible middot When the bill is received it should be checked against the details recorded and anomalies if any should be reported to the supplier

To keep a track of the received stock maintaining a S t o c k R e c o r d C a r d c a n b e very useful The entries in the stock record card can be made while checking the stock received STOCK BIN in the stores should have Stock record card

Maintaining a stock card for every product may not be very practical for a retail pharmacy however it could be maintained for costly medicines Nowadays it is much more practical and easier to maintain records using computers

The pharmacist should ensure that medicines manufacturedmarketed by a company are received only through an authorized distribution network of that company This is important to prevent spurious and counterfeit drugs from entering the pharmacy

37

2 STORAGE 21 The need for proper storage The storage of medicines and other products is an important requirement of Good Pharmacy Pr actice Appropriate storage of medicines is essential -

middot bullTo ensure that the potency is maintained middot bullTo prevent deteriorationspoilagedegradation middot bullTo ensuremaintain physical integrity

To ascertain that the quality and safety is maintained throughout their shelf life Storage requirements need to be considered on 2 aspects

a) Integrity of medicines Medicines should be stored in such a way so as to maintain their integrity and potency middot Maintain the right temperature required middot Protect from excessive humidity middot Keep medicines away from direct sunlight middot Protect from pests and rodents

b) Physical location middot Should be easy to locate middot Accessible middot Orderlysystematically placed

2 2 D i f f e r e n t p a t t e r n s o f s t o r a g e The pharmacist could follow any of the different patterns of storage The pattern of stora ge should be selected in such a way that it facilitates speedy and efficient dispensing of medicines

The pattern of storage could vary with each pharmacy experience usual practiceroutine of staff and the person-in charge and also depending on space av ailable turnover etc (i) The medicines could be stored c o m p a n y w i s e ie the medicines manufactured by one company should be grouped together and kept in one place Within each company shelfshelves the medicines may be placed in alphabetical order for easy and quick placement and removal Also bottles tubes boxes etc may be segregated within that shelf

38

(ii) The medicines may also be stored in a lphabe t ic al o r de r ie they are placed in order from left to right based on their name The first letter of the name is used to g r o u p t h e m e d i c i n e s t o g e t h e r a n d k e e p t h e m i n o n e l o c a t i o n I n s o m e p h a r m a c i e s a l l t h e strip packing are placed in drawers or boxes in alphabetical order each box or drawer containing strips of one particular alphabet This system ensures that the strips always remain e n c l o s e d i n t h e b o x e s d r a w e r s a n d a r e n o t e x p o s e d t o d u s t T h e d i s a d v a n t a g e i s that it might lead to mix -u p o f strips in the same drawer and it may cause a problem incase of similar looking strips in which case a wrong medicine may be dispensed Secondly cut strips lying around in the drawer may lose their identity if the batch n u m b e r andor expiry date is not seen on the cut portion of the strip

39

(iii) The medicines may be stored according to their therapeutic class ( e g a n t i b i o t i c s anti asthmatics or anti hypertensives) ie the medicines are kept together based on their pharmacological or therapeutic action

(iv) The medicines may be stockedsegregated according to dosage forms eg l i q u i d s (bottles) solid oral dosage forms eye drops rotacaps ointments etc all stored on separate shelves

Always Remember I Storage of prescription medicines should preferably be separate from OTC medicines OTC medicines especially those that a r e a d v e r t i s e d m a y b e d i s p l a y e d f o r c l i e n t s t o select or to ask questions about [OTC-O v e r t h e c o u n t e r ] II Storage according to temperatures is a must no matter which pattern of storage is followed Also within a particular storage area segregated storage may be maintained In a refrigerator for example medicines may be stored in trays racks and the freezer according to the temperature required

40

Whatever pattern of storage is selected all the personnel should ensure that middot The stocks are stored in an orderly manner middot The medicines are kept back in the same place from where they were removed middot All medicines are arranged neatly once in a while

middot The personnel should be careful while storing the medicines middot They should not throw the medicines haphazardly 23 Different means of storage

middot Within each temperature and security zone medicines must be stored so that they are easily accessible and protected against damage

middot Basic means of storage include shelves racks and drawers middot To prevent dust from entering the shelvesracks it is ideal to have glass

shutterssliding glass doors This can however be disadvantageous because accessibilityspeed is hampered in removing a product from the shelf because the glassshuttersliding glass has to be

41

opened m o v e d e v e r y t i m e a p r o d u c t h a s t o b e p i c k e d u p U s e o f a i r c o n d i t i o n e r s f o r t h e p h arm acy with a closed door at the e n t r a n c e o r a n a i r c u r t a i n c a n r e d u c e t h e d u s t problem In such cases the shelvesracks may be left o p e n

bull

middot Direct storage of cartons on the floor should be avoided because besides being an unhealthy practice the contents may also be damaged by moisture bull

middot Store medicines preferably in shelves with glass shutters for visibility middot Closed shelves further prevent dust from going in especially in India where most

pharmacies are located along busy roads middot Some medicines have to be refrigerated or stored in a cool or cold place Having a

refrigerator or two (as per the need of the pharmacy) is essential to store suc h medicines at temperatures mentioned on the label bull

42

Refrigeration middot All cold chain equipment should meet required standards middot Improvement in refrigeration technology has provided frost -free refrigerators

Pharmacists should opt for frost-free refrigerators as they are easy to maintain and protect printed packaging materials Conventional refrigerators may cause water falling from trays below the freezer on medicines stored in the refrigerator thus causing soggy labels

middot bull Frost-free refrigerators also provide separate and large compartments for the freezer portion (required for storing medicines needing sub-z e r o t e m p e r a t u r e ) and the main storage area with separate doors so that opening one door does not disturb the storage temperature in the other compartment

Care should be taken to keep the refrigerator on 24 hours a day It should not be switched off after working hours It is advisable to have an inverter connected to the refrigerator so that the refrigerator re mains working even when there is a power outage

middot The refrigerator door should be closed tightly middot The refrigerator door should not be left open for too long middot Space should be left between medicines stored in a refrigerator to allow air to

circulate middot The ref rigerator should be placed about an arms length away from the wall

This will increase air circulation thus not affecting the cooling within the refrigerator

middot Vaccines should not be stored on refrigerator door shelves as they are exposed to warmer temperatures each time the door is opened Vaccines should always be stored on the middle shelves of the refrigerator

middot Refrigerated medicines should not be left out of the refrigerator for more than a few minutes

43

middot Consumable products like juices energy drinks e t c s h o u l d n o t b e s t o r e d a l o n g with medicines in refrigerators If required they may be kept in a separate refrigerator

middot An adequate number of refrigerators should be planned to store the entire stocks requiring refrigerated storage

middot Adequate procedures should be followed for defrosting cleaning and maintenance of refrigerators

middot Icefreeze packs should be kept in the freezer compartment so that they can be used for transporting cold temperature medicines The packs can be given to clients along with the medicines requiring cold temperature storage so that the temperature is maintained till the client reaches home and can then put the medicines in a refrigerator) Freezer packs can also be used to keep medicines temporarily in case there is a power outage or refrigerator breakdown

Activity

Prepare a SOP (Standard operating procedure chart) for cleaning a refrigerator Discuss it with your staff finalize its maintenance once a month through AMC -A n n u a l Maintenance contract CMC - Comprehensive maintenance contract and put it up on the pharmacy refrigerator Put the Purchase Order details name of manufacturer Phone of Service Engineer and a register to login the Machine service and down timeService reports may be maintained properly

Refrigerator monitoring and maintenance

middot bullIt is important to carry out routine monitoring and maintenance of the refrigerators and to organize an effective repair system

middot bullThe temperature in the refrigerator must be monitored and recorded routinely at least once a day

middot Any breakdown must be reco rded including the period during which the medicines were exposed to uncontrolled temperatures Medicines may then be kept or discarded depending on the problem guidelines or the manufacturers advice

middot Cold chain monitor cards and devices in or on packages that change color or otherwise alert staff to potential damage assist in monitoring (These are likely to be introduced in India soon)

middot It is essential to have a contingency plan in place before a refrigerator breaks down An arrangement can be made to move the contents to a private refrigerator elsewhere in the community or to obtain a regular supply of ice packs until the defect is rectified

Put filled water bottles in the bottom half of the refrigerator door in order to provide cooling in the refri g e r a t o r w h e n t h e r e i s a p o w e r o u t a g e T h i s m i g h t t a k e c a r e o f t h e temperature when there is no current for a couple of hours If the power outage is expected to last for several hours special arrangements such as an inverter UPS have to be made to keep the refrigerator constantly running in the absence of electricity middot Defrost the refrigerator in case of excessive ice formation and preferably at regular

intervals Keep a record of the same

44

2 4 T e m p e r a t u r e c l i m a t i c c o n d i t i o n s

i) Temperature control middot The medicines in a pharmacy need to be stored at appropriate temperatures to

maintain their stability middot An air-conditioned environment where temperature can be controlled is

recommended for pharmacies Air conditioning offers the option of setting the t e m p e rature as per requirements

middot bullIt is ideal to have an air conditioner to maintain the temperature below 25 C as most medicines require storage below this temperature Secondly this temperature is pleasing to both the staff and the visiting customers too

middot In the absence of an air conditioner circulating fans may be used middot This need is felt even more in certain parts of India where temperatures soar above 45

C and some areas where it falls to sub zero temperatures In such cases temperature maintenance is essential to prevent deterioration of medicines due to unnecessary exposure to drastic temperature fluctuations

middot This need is felt even more in certain parts of India where temperatures soar above 45 C and some areas where it falls to sub zero temperat u r e s I n s u c h c a s e s temperature maintenance is essential to prevent deterioration of medicines due to unnecessary exposure to drastic temperature fluctuations

i i ) Humidity or moisture control Moisture or humidity can adversely affect the stability of me dicines such as tablets capsules powders

45

Gelatin capsules become soft and swell on absorption of moisture The drug content of tablets may undergo surface hydrolysis The presence of moisture may encourage the growth of microbes It is therefore essential to control humidity

To reduce the effect of humidity the following suggestions may be followed -middot Open the windows to allow air circulation Use a fan to circulate fresh (outside) air middot In humid climate a dehumidifier is useful for preventing mo i s t u r e d a m a g e ( i n t h e absence of an air conditioner) middot For bulk containers of tabletscapsules do not keep the container open for a long time and replace the lid or closure immediately after taking out the required number of medicines for dispensing middot Do not allow the medicines to touch the floor or the walls The walls may be damp and may cause moisture absorption damaging the product

middot Calibrated thermometers and manometers can be used to detect temperature and humidity in the pharmacy

middot Periodici t y of checking the temperature should be fixed middot The climatic conditions should be recorded and documented middot Temperature charts should be available for ready reference

Documentation is one of the core activities for achieving and maintaining quality It is one of the most essential components of validation Temperatures in various areas

46

including refrigerators should be recorded at a predetermined periodicity usually daily at the hottest time of the day and such documents should be preserved i i i ) Storage conditions A number of storage conditions are mentioned on the labels of medicinal products These conditions have to be properly interpreted and appropriately complied with

According to the Drugs and Cosmetics Rules 1945

1 The term cool place means a place having a temperature between 10 C and 25 C

2 The term cold place means a place having a temperature not exceeding 8 C In case of storage conditions for specific products please refer to Schedule P The Drugs and Cosmetic Rules 1 9 4 5

The Indian Pharmacopoeia specifies the following storage conditions -

Wherever the condition for storage is not specified medicines may be stored under normal temperature In a country like India however where normal temperatures soar to h i gh temperatures it is recommended that medicines be stored in a cool place

Activity Prepare a list of the storage requirements mentioned on the label of about 20 products in your pharmacy and check if the temperature is maintained

47

25 Special Storage o f s u p p l i e s If the product has no special instructions normal storage conditions apply This means storage in dry clean w e l l -ventilated premises at temperatures of +15 C to +25 C or depending on the climate up to +30 C (WHO1990) Storage instructions are product specific Different brands of the same generic drug may have different storage requirements as they may have different packaging or formulations It is essential to follow the product manufacturers storage instructions to the maximum extent possible Less stable medicines must be stored in specific conditions to maintain their quality or potency

The following products require special storage facilities

middot Products that must be kept frozen (usually vaccines and sera) middot Products sensitive to h eat an d r e q uir in g r e f r ig e r a tio n ( +2 C to +8 C) middot Products that have reduced shelf life at uncontrolled room temperature and need

mechanical ventilation or air conditioning middot Flammable products that require separate fireproof premises middot Products prone to theft o r m i s u s e

Products needing storage in a controlled environment -

The usable shelf life of the following products may be reduced if stored at uncontrolled humidity or at room temperature in hot climates -

middot Some injectables (eg adrenaline) Most injectable preparations are less stable than solid oral forms (tablets and capsules) Injectable preparations in solution are particularly unstable Many injections must be protected from light as well as heat

middot Intravenous fluids (particularly if packed in p lastic containers) middot Some suppositories pessaries creams and ointments These products may melt at

temperatures greater than 30 C Once this happens it is not advisable to use them because the active ingredient in the formula may get unevenly distributed

middot Products containing rubber latex cellulose or some plastics Condoms most sterile disposable medical devices and surgical products such as syringes needles and catheters require protection from excessive humidity and strong light and heat Any o f these conditions may make products brittle stained amp unusable Sterility cannot be assumed if packaging is damaged

In hot climates these products should be stored in the coolest place possible preferably with air conditioning or air circulation fans

48

Products needing freezing or refrigeration-middot Vaccines blood products and many other medicines lose potency if kept even for a

brief period at temperatures outside the recommended range For these products the cold chain must be maintained at every stage of the distribution system

middot Freezing is as damaging as high temperatures for some products including injectable contraceptives ergometrine insulin adrenaline and the DPT DT TT and Hepatitis B vaccines Such products therefore sho uld not be allowed to freeze (not be kept in the freezer compartment)

middot Short periods at room temperature (during transportation or local distribution for instance) may be acceptable for many products (such as ergometrine a n d i n s u l i n ) e v e n t h o u g h s u c h e x posure can to some extent reduce shelf life Other items such as vaccines should always be transported in cold boxes

Storage of insulin injections-

middot Insulin should always be stored in a refrigerator at the recommended temperature of 2 -8 C

middot Insulin should not be kept in the freezer compartment of the refrigerator middot Insulin should ideally be stored horizontally middot It should not be exposed to sunlight or excessive heat middot Insulin suspensions should not be used if the suspension cannot be properly

resuspended due to cake or clump formationbull

Controlled drugs -Narcotics (for example Pethidine injection morphine preparations) and other specified drugs that may be abused are governed by special legislation and regulations The following security measures are suggested in the pharmacy -middot A safe or reinforced double locked cabinet fitted with a light (preferably with a red

bulb) that comes on when the door is opened

49

middot A special register recording details of each receipt or issue with 2 signatures physi cal counting of medicines after each entry and signatures at handover takeover

middot Independent audit (by supervisors and drug inspectors)

Products prone to theft abuse or misuse -

Some medicinesproducts are particularly prone to theft abuse or misuse These include expensive medicines (eg insulin) certain antibiotics and products prone to abuse or misuse like psychotropics etc

Such medicinesproducts should be stored adequately They require stricter record keeping and more frequent stock taki ng than others Periodic audits should be carried out to check for consumption against actual recorded use (registers prescription records stock records etc) to expose any theft or misuse bull26 Storage and stability of medicines Medicines are not stab le indefinitely They are stable for a specific period of time sometimes for a brief period Poor storage conditions accelerate the drug degradation (decomposition) Temperature light and moisture are the most important contributing factors for drug instability It is important to identify and be aware of the potential for instability There is a need to comply with storage requirements to ensure quality medicines for patients It is also important to offer advice to patients too about appropriate storage o f medicines at home The dispensing label should state the storage condition required and be backed up by a verbal reminder especially where special storage is required bull

50

In case stability and storage problems are seen with formulations they should be reported immediately to the representative of the manufacturer and taken out of circulation till the stability problems have been resolved

The pharmacist can easily detect stability problems when products show change in appearance color odor settling of the product contents breaking of emulsions melting of creams oozing of contents from the containers and any such physical changes

3 STOCK CONTROL AND EXPIRY MONITORING 3 1 S t o c k C o n t r o l For economic reasons pharmacists do not like to have stock on their shelves for long periods of time The aim should always be to keep stock at a level that will just meet demand Normally most manufactured medicines have a long shelf life Even then it is essential that there is efficient stock rot ation so that the older stock is used first It is also a good practice to check the expiry date as an integral part of the dispensing process When short shelf life products are involved stock levels may have to be modified to prevent medicines regularl y expiring on the shelves

32 Stock rotation and expiry monitoring In order to avoid accumulation of expired and obsolete stock medicines should be stored and issued according to the following guidelines -middot The stock control system must record the ex p i r y d a t e a n d t h e d a t e o f r e c e i p t middot Stock must be stored so that earliest expiring batches are picked and issued first middot The First In First Out (FIFO) system - In this system the stock which is received

first is sold first This system however may not be useful for pharmacies because most of the stocks carry an expiry date For pharmacies the FEFO system is more practical

51

middot The First Expiry First Out (FEFO) system - In this system the stock having an earlier expiry is sold first The stock with longer shelf life should be placed farthest to the back (or at the bottom in case o f sta c k e d b oxe s) T h is is pa r tic u la r ly impor ta n t with products that have short shelf lives such as vaccines some vitamins antibiotics etc and reduces losses due to expiry

middot E x p i r y dates should be noted on the stock record upon receipt Stock nearing expiry should not be accepted unless it can be used before expiry

Computerization and expiry monitoring In the pharmacy computerization facilitates both checking stocks and expiry mo nitoring and helps-bullbullKeeping a check on products nearing expiry bullbullKeeping a check on non- moving and slow moving products bullbullTo facilitate the removal of medicines nearing expiry from shelves in time to send them back to the wholesaler or supplier

Periodic checking for expiry The expiry date for medicinal products is a critical aspect in pharmaceutical dispensing and due importance should be given to it Periodic checking for expiry of medicines will ensure that the patient will never receive products that have crossed their expiry date During periodical checking of expiry the personnel involved should remove medicines that are nearing expiry bullbullIn -house threshold periods should be set and followed for retrieval of such medicines from the shelves bullbullSuch medicines should be stored separately These should either be dispensed immediately (thus ensuring that they are used before the expiry date) o r t h e y s h o u l d b e returned to the suppliers bullbullA separate area should be designated (cupboard or shelf)marked[FROZEN ZONE] which is adequately marked EXPIRED GOODS- NOT FOR SALE to store all expired stocks FROZEN ZONE

52

Remember Expired medicines are a NATIONAL WASTE So stock only what you can sell Avoid expiries save precious medicines for the nation

Treatment and disposing of expired medicines bullbullProcedures need to be in place for the treatment of expired medicines bullbullThe expired medicines need to be collected and be sent back to the supplier or company for appropriate disposal bullbullRecords must be maintained for expired medicines and how they are disposed off bullbullIn case of medicines that are not returnable to suppliers procedures for disposal need to be followed by the pharmacy in conjunction with the FDA The following procedure can be followed if medicines cannot be returned to suppliers ( T h e b a s i c p h i l o s o p h y of appropriate disposal is to prevent their re- circulation and use) bullbullC u t t h e c o n t ainer in such a manner that the label is also cut In case of tablets and c a p s u l e s d e s t r o y them by disposing them in a bucket of water bullbullUse landfill procedures (deep burial into the ground as per stipulations of Medical Waste Disposal Act prevalent in the respective state) bullbullPour the liquids into the sink and wash away with sufficient quantity of water bullbullKeep a record of such disposal with full details of medicines destroyed Although these measures are usually adopted care has to be taken with such tr e a t m e n t a s studies have shown that flushing of medicines has resulted in tracessmall quantities of medicines being found in waterways and groundwater having potential health and environmental effects

4 O T H E R A S P E C T S 41 Design of storage areas The following important factors need to be considered in design of storage areas -middot The retail outlets in hot areas in summers should be air-conditioned Similarly in

a r e a s o f e x t r e m e c o l d t h e p r e m i s e s w o u l d r e q u i r e w a r m i n g e s p e c i a l l y i n w i n t e r s t o maintain cool temperatures The placement of air -conditioners and heating devices should be such that medicines are not directly exposed to the cold or heat

middot Due consideration should be given to storage requirements of formulations while designing shelves and cupboards in retail outlets Sufficient shelf height should be provided so that all liquid products can be stored vertically As far as possible the shelves should be covered with glass panels to protect medicines from dust and p r e v e n t r a p i d f l u c t u a t i o n s i n temperature

middot Medicines should be stored according to the storage instructions on the labels bullIt is ideal to have a door at the pharmacy entrance to prevent dust from coming in as well as reduceprevent cooled air from going out This may not however be considered feasiblepracticable by many pharmacy owners for fear that clients may not enter the pharmacy because the door may act as a barrier An air curtain is a good alternative to a door

middot There should be minimal direct sunlight falling on the products Particular consideration should be given to premises directly facing the sun

middot bullThe arrangement of lighting in the interior of the premises should also be in a manner that the lights are not focused on the products It has been shown that light causes not only chemical damage but also can catalyze physical changes like moisture uptak e by the products Care should be taken to ensure that only diffused light falls on them

53

middot As far as possible provision should be made for a temperature and humidity indicator device in a pharmacy These devices are now easily available

middot Stability studies o f m e d i c i n e s p a c k e d i n b l i s t e r s h a v e r e v e a l e d t h a t i f t h e s e a r e exposed to light they tend to absorb moisture It is therefore necessary to store them in suitable cartons so that the blisters are not exposed to light Pharmacists should do this even if the manufacturer has not provided cartons

middot Light and temperature sensitive products should not be stored on counters where the light is intense or direct and there is no protection from temperature and humidity

42 Cleaning and maintenance i) Cleaning of storage areas

The storage areas of the pharmacy should be cleaned periodically and cleanliness should be maintained at all times The Standard Operating Procedure for cleaning should be designed and followed accordingly Schedules for cleanups should be laid down and adequate cleaning equipment should be made available

Tips for maintaining cleanliness middot Provide clean pieces of cloth for wiping at various locations in the pharmacy

Replace with clean cloth at regular intervals middot Keep separate pieces of cloth for floors shelves and medicines middot Use a disinfectant andor soap solution to clean floors middot Ensure removal of dust and prevent accumulation of dirt middot Ensure removal of cobwebs middot Use a vacuum cleaner for cleaning areas not easily reachable middot T a k e c a r e t h at breakages are handled and cleared effectively middot Observe the factors leading to waste generation in the pharmacy and take appropriate

measures to tackle the problem middot Record all cleaning procedures performed and maintain all the documents required

For ex a m p l e -bullbullThe floor of the pharmacy may be swept with a broom and swabbed with soap water every morning bullbullThe floor may be swabbed with a disinfectant every week bullbullThe entire premises including shelves and cupboards may be cleaned with a cloth (to remove dust and to check for medicines approaching expiry date or expired medicines) every three months bullbullAll the steps followed should be r e c o r d e d

The floor shelves drawers have to be cleaned and a check should be kept on dust cobwebs spillages due to breakage etc It is therefore essential to have SOPs for cleaning laying down cleaning frequencies allotting responsibilities and maintaining a daily record in the logbook to document all these activities

54

While cleaning dust settled on dosage forms like bottles tubes etc should be removed Before dispensing the products should also be wiped to remove any dust settled during storage

For refrigerators bullbullDefrosting and cleaning should be done at regular intervals bullbullSwitch off the refrigerator while cleaning bullbullCleaning should be done quickly and stocks put back immediately

i i ) Pest control Pests are a serious problem in India where insects reptiles and rodents (eg cockroaches l i z a r d s r a t s s i l v e r f i s h (Deemak - in Hindi ) etc) may find access to the pharmacy storage areas Insects like ants and borer ants may often attack wood in the pharmacy causing d am ag e to shelves cupboardsPest c ontr o l in a p h a r m a c y c a n b e a d i f f i c u l t t a s k b u t t o avoid possible contamination and physical damage to stock it is necessary to keep pests out of the pharmacy premisesPest control measures should be implemented with proper p r e c a u t i o n s t a k i n g u t m o s t c a r e t o a v o i d contamination of medicines

55

Th e following pest control measures c a n be ta ke n f r om tim e to tim e -bullbullRat bait and traps can be placed at various locations bullbullInsecticutors can be used on a permanent basis bullbullInsecticidal sprays and repellants can be used from time to time

i i i ) Fire precautions

Combustible trash such as cartons boxes and other packing waste must not be allowed to accumulate in the store Waste should be deposited in appropriate waste bins and be d i s p o s e d o f f o n a d a i l y b a s i s

F i re detection and fire fighting equipment must be maintained and regularly inspected The pharmacy personnel should receive adequate training in fire fighting techniques and emergency actionFire prevention measures should include a prominently displayed ldquoNoSmokingrdquo sign careful handling and disposal of combustible waste materials and checking of electrical connections at regular intervals

iv) Security middot Doors shutters of the pharmacy should be strong and be fitted with secure locks middot Counters should be designed so that unauthorized personnelclients do not have

access to areas where prescription medicines are stored Access to such areas should be restricted to the pharmacy staff

middot All the pharmacy staff handling supplies should be accountable for their ac t i o n s

56

middot bullSpecial care must be taken in case of Schedule X and manufactured drugs (under NDPS Act) Such medicines should be kept under lock and key and the key should be kept with the Chief Pharmacist or i n h i s a b s e n c e t h e s e n i o r p h a r m a c i s t

v) Breakagespillage and damaged product Products that have been damagedspoiled during storage and handling spillages and broken glassware should be disposed off according to procedures laid down by the pharmacy Broken and damaged products s h o u l d b e p l a c e d i n a segregated area to be returned to the supplier

vi) Inspection Senior staff should inspect all pharmacy areas regularly The shelves and drawers should b e c h e c k e d d a i l y f o r signs of pests and dust Ceiling and walls should be checked for dirt and cobwebs Stock should be checked on a regular basis for deterioration due to climatic conditions

43 Product recalls Products found to be defective should be quickly recalled (withdrawn from the market) The instructions are generally issued either by the manufacturer or the regulatory agency The level of recall is determined by both the degree of risk and the extent of distribution of the product and in India is mainly directed at the distribution chain

On receiving the details of the defective substandard spurious batchbatches of a medicine to be recalled from the manufacturer or the stockist or the FDA the pharmacy should immediately check if the particular b a t c h i s i n s t o c k a n d i f s o s u s p e n d i t s s a l e immediately

Similarly if the regulatory authority in the country bans a particular medicine or FDC the pharmacy should immediately check and remove all the different brands of that particular medicine under consideration

The details of medicines and their batches to be recalled should be available in the q u a r a n t i n e a r e a w h e r e stocks are received and checked This is to ensure that such medicines do not come into the pharmacy

middot The pharmacy should develop SOPs for recall of medicines middot The pharmacy staff should be immediately informed about such medicines and

the details should be displayed in writing in a prominent place in the pharmacy middot Rapid action helps avoid unnecessary exposure to such medicines once the

problem has been d e t e c t e d middot The progress of the recall procedure in the pharmacy should be monitored every

few days to ensure complete compliance middot All stocks of the recalled products should be stored separately from the saleable

stock These can be stored in the expiry cupboard segregated from the expired goods and be appropriately labeled ldquoRecal l e d G o o d s - Not for Salerdquo

The supplier should be notified and asked to replace defective products middot All the details of the procedures followed should be duly recorded in a Recall

Register maintained specially for the purpose The register should include d etails such as -middot Date of the recall middot Nam e of the product

57

bullbull

middot Details of the product (name of manufacturer batch number expiry date) middot Nu m b er of units purchased sold a n d sto c k in ha nd middot Reason for recall middot Nam e of the supplier to whom produc ts w e r e returned along with the date and quantity middot Name and signature of the designated personnel carrying out the recall procedure and recording details middot Name and signature of the chief pharmacist verifying the recall procedures and recording details 4 4 Returned medicines

Medicines may be returned to the pharmacy by clients due to the following reasons -bull

bullbull Unused medicines bullbull Course not completed bullbull Therapy changed by doctor bullbull Side effects experienced by patient bull

bullbull DamagedDefective medicines bullbull Missing or defaced label bullbull Missing tablets in a stripblister bullbull Leakage in bottles bullbull Leakage in strips bull

bullbull Expired medicines

Appropriate SOPs should be framed and followed for their acceptancerefusal and disposal middot bull For unused medicines returned by clients the p harmacy personnel should verify

that these were purchased from their pharmacy They should then be checked for integrity of the packing the dosage form and the expiry date and verified with the client whether they were stored in appropriate conditions This again is at the discretion of each pharmacy

middot The damageddefective medicines returned to the pharmacy should be taken back and stored separately Existing stock of the same product should be checked for similar defects

middot Expired medicines should be accepted from clients at the discretion of the pharmacist and be immediately shifted to the expired goods cupboard These can be stored segregated from the pharmacys own expired goods and be appropriately labelled ldquoExpired Goods returned by clients- Not For Salerdquo

It is advisable not to accept returned medicines requiring cold chain storage (refrigeration) because it cannot be ensured that the cold chain was maintained when the medicines were in the hands of the patientclient middot Appropriate adjustments in t he stocks should be made for medicines

returnedexchanged to update the inventory middot The medicines should then be returned to the respective shelves middot A lsquoReturned Goodsrsquo register needs to be maintained to record all details of returned

medicines

R egister should include such details as-

58

middot N a m e o f t h e p a t i e n t middot Nam e of the product and quantity r e tu r n e d middot Product details such as the batch number and expiry date middot Condition in which received middot Reason for returning products middot Compensatory measures taken wi t h r e s p e c t t o c l i e n t middot Action taken with respect to product middot Name and signature of the personnel accepting the returned medicines and recording details middot Name and signature of the chief pharmacist verifying the recorded details

What the pharmacist would have learnt from this module The storage of medicines is a critical factor in the distribution cycle bullbull Stocks received by the pharmacy should be quarantined in a separate area and necessary checks s h o u ld be performed to ascertain the qua lity a nd quantity of stocks received bullbull Whatever pattern and means of storage used the products should be stored so as to maintain their potency and integrity bullbull Storage conditions should be monitored and maintained on a regular basis bullbull Optimum stock levels should be maintained and regularly monitored for expiry bullbull The design of storage areas should facilitate appropriate storage of medicines bullbull Cleanliness should be maintained in the pharmacy bullbull Adequate measures should be taken in case of returned medicines and recalled products

Optimum storage of medicines is mandatory whether at the distribution stage at the pharmacy or ultimately within the homes of patients The pharmacist has an important r o l e t o p l a y i n t h e s t o r a g e o f m e d i c i n e s i n m a i n t a i n i n g d r u g p o t ency and efficacy and thus facilitating optimum therapeutic benefits Good Pharmacy Practice - IPA -CDSCO - WHO Appendix I Quality Assurance Templates of letters for use if found not of Standard Quality [Frozen and expired goods ]

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated To Name of the Supplier with address

Sub Not of Standard Quality GoMP-Supply of Drugs and medicines-(Codename) Return of Stocks to the Suppliers-reg(New drug policy 2009) Previous letterinvoice ref Sl No Drug Code Drug name

Manufacturing date Expiry date

Supplier address

B a t c h n o

The above items of PO nodated was drawn by the Drug Inspector (Place) on (______________date) as a statutory sampling and declared ldquoNot of Standard

59

Qualityrdquo on -(______________date) by the Government Analyst for the following reasons

- ldquoThe product sample do not confirm to IP specification for (Drug codename with respect to the content of drugrdquo

- ldquoThe product has already been blacklisted by TNMSC on -(______________date) for the failure of (quantity) of batches of drug codenamerdquo

As per the clause of the te nde r d oc um e nt ldquo I f the sa mple s d o not c onf o r m to statutory standardsthe tenderer will be liable for relevant action under the existing laws and the entire stock in such batch should be taken back by the tenderer within a period of 30 days o f t h e r e c e i p t o f t h e l e t t e r f r o m t h e v e n u e

The stock shall be taken back at the expenses of the tendererthe Procurement Authority have the right to destroy such Not of Standard Quality if the tenderer does not take back the goods within the stipulated time

The Procuring Authority will arrange to destroy the Not of Standard Quality drugs within 90 days after the expiry of 30 days mentioned above without further notice and shall also collect demurrage charges calculated at the rate of 2 per week on the value of the drugs rejected till such destructionrdquo

Hence we regret to inform you that you will have to take back the stocks available of the abovesaid batch at your own cost from the drug stores where you have supplied the above batch

Kindly acknowledge the receipt of this reference at once

P r o c u r e m e n t A u t h o r i t y Seal and Stamp

Copy to Ref No dated

1 ) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated13082010

To

Sub Frozen Drugs-ordered to return to the Suppliers-reg(New drug policy 2009) Previous letterinvoice ref

The following products which were earlier frozen have now been ordered to return to suppliers directly with permission from the State drug Authority In this regard the suppliers have been instructed to take back their failed batch from the drug store of the stores Hence you are now instructed to return the following failed batches to the suppliers by obtaining proper authorization letter and acknowledgements from them

60

Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

Kindly acknowledge the receipt of this reference at once

Procurement Authority Seal and Stamp

Copy to

Ref No dated 2) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated14092010

To

Sub Frozen Drugs-ordered to return to the Suppliers- for issue of gate pass after verification reg(New drug policy 2009) Previous letterinvoice ref

The following products which were earlier frozen have now been released Hence they may be issued Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

Kindly acknowledge the receipt of this reference at once

Procurement Authority Seal and Stamp

Copy to

61

Ref No dated 3) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated

To

Sub Stop instruction-reg(New drug policy 2009) Previous letterinvoice ref

Until further instructions stop issue all the batches of the following item Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

You must intimate the available stock in the stores of the said batch Number to the Procurement Authority immediately Also retrieve quantity if already issued

Procurement Authority Seal and Stamp

Copy to

Ref No dated 4) HOD Procurement Office of

62

Appendix II Material handling in drug stores

Rack approx rates and dimensions

S No

Item Description UOM Approx Rate

1 MEDIUM DUTY RACK SIZE 2900 H X 3090 W X 800 D IN MM (AS PER SPECIFICATION)

Each 2499800

2 MEDIUM DUTY RACK ADD ON UNIT FOR SIZE OF SR NO2

Each 2243100

To locate a Box no 3 Rack no 14 in row3

SAMPLE OF RACK no Bin numbering -------------- S a y R K 1 4 R o w 3 B o x 1 6

SAMPLE LAYOUT of RACKS in a Drug Stores

63

Sample of another warehouse of distribution warehouse system

64

65

Slotted Angle racks with bin cards

66

Plastic Pallets

Plastic pallets ar e l i g h t w e i g h t l o w- c ost and exceed industry standards for strength and durability

NOTE A pallet has bottom deckboards (see sketch) A skid does not have bottom

67

deckboards

Battery Operated Stacker

Electric Stacker Ehh (Manual Push Type) - Manual drive - Lifting electrically with Battery 12 V 88 Ah - For loading and un-loading of trucks - Battery and loading device built - in - Battery charge gauge and charging current gauge Simple and Easy Operation - Lifting and Lowering electrically direct on steering arm - Pulling and pushing through steering arm - Electrically operated relief valve on hydraulic aggregate Safe Operation - Emergency Off Switch - Constant lowering speed - Protection through lowering brake valve - Overload protection through overload brake valve - Load chains covered preventing pinching threat - Electrically interlocking during loading process - Secured battery compartment opens upwardly - Stable buffering of the steering arm in upright position - In accordance with EWG Guidelines 89 240 - In accordance with VBG 12b Prevention of Accidents

Pallet Truck [ Top ]

68

----------------------------------------------------------------------------------------------------------------------------

For Transport Of All Goods On Pallets Safe and Easy Operation - through single hand operation Lifting moving

lowering with steering handle - neutral position of the hydraulic possible - overload pressure relief valve Long Service Life - robust co n s t r u c t i o n

- special hardened axles - hardened chromium plated ram - maintenance free Easy Maneuverability - through rubber steering rollers - nylon fork rollers

A h a n d t r o l l e y

69

Trolley with plastic bins for several items del ivery

70

Digital Weighing balances

Balances amp Scales EF Seriers Precision Electronic Balance

71

1

Ice lined Refrigerators

600 litres refrigrator

72

Walk in cooler

vacuum cleaner

73

Annexure A WardSection Indent Register No Issued on

Name of institution Page Folio No

Serial no Name of Article Quantity in Stock

Quantity required

Prepared by Approved by Recd by Note-Indenting Officer to sign and affix seal with name and

designation below the last item to avoid additions in one strokeno issues to be made by storesif Issue vouchers of

previous Indent has not been returned back by the WardSection

20

Annexure B Issue Voucher No (printed number)

Supplied to Wardsection Date

Indent no

Serial no Name of Article Quantity in Stock

Quantity required SB No

Stores-in MO Resident in Sign of charge charge WardSection

NurseCompounder Prepared by Recd Approved by by

Note-Indenting Officer to sign and affix seal with name and designation below the last item to avoid additions in one strokeno issues to be made by storesif Issue vouchers of previous Indent has not been

returned back 1st copy-Stores 2nd copy -Wardsection3rd copy-Tobe reurned to sores with Stock book entries

21

Annexure C

STOCK REGISTER FOR DEAD STOCKS

SERIAL NO DATE OF RECEIPT

Article with description

No of pieces Cost Details of

Bill Signature No Disposed

Date of disposal

Manner of Disposal

with Authority

Value realised Signature

1 2 3 4 5 6 7 8 9 10 11 12

P r e p a r e d B y C h e c k e d b y A p p r o v e d b y

Date Designation Name of Institution

22

Annexure D

STOCK REGISTER FOR EXPENDABLE ITEMS Name of article

Date

From where

received with cost

Quantity Signature To whom issued Quantity Balance Signature

1 2 3 4 5 6 7 8

23

Annexure E

Receipt amp Issue Register for WARDSSECTIONS (one or more pages as per requiremnt for each medicine)

NAME OF MEDICINE RECEIPT ISSUE

DATE Quantity In Stock

Date of

Issue

Issued toMention Bed no amp

quantity (in bracket) (For

Outdoor cases give Regd No)

Balance Signature

24

Annexure -F

OUTDOOR FREE MEDICINE SLIP In Duplicate

Name of Patient Registered No Date

Sr no Name of Medicine Quantity

Seal amp sign of doctor

25

Annexure-G

TREATMENT CARD

WARD NO

NAME OF PATIENT BED NO DATE amp TIME OF ADMISSION DATE amp TIME OF DISCHARGE

DATE MEDICINES PRESCRIBED SIGNATURE

26

ANNEXURE -H

PROFORMA FOR BREAKAGE amp LOSS

NAME OF OFFICEINSTITUTION DATE PLACE

SRNO NAME amp

DESCRIPTION OF ARTICLE

COST DATE OF PURCHASE

REASON CAUSE OF BREAKAGE

RECOMMENDATION OF INVESTIGATING AUTHORITY

Signature

Orders of the Competent Authority

Signature

27

Annexure ndash I Loss- Procedure for Reporting

1 The exact nature of the defalcation 2 The full extent of loss 3 The actual period covered by the defalcation 4 The defects in the negle c t o f r u le s by w hic h the loss was rendered possible

and circumstances which facilitated the defalcation 5 The names of the officials held personally or technically directly or

indirectly and wholly or partially responsible for the irregularity c o m m i t t e d i n t h e c a s e

6 Whether the c a s e a s b e e n J u d i c i a l l y t r i e d i n a c o u r t o r n o t i f s o c o p i e s ( i n duplicate) of the Judgment may please be furnished Copy of police report may also be furnished

7 The remedial measures adopted as safeguards against the losses hereafter 8 The prospects of re covery of the loss and he action taken to effect

recovery together with the amount recovered 9 Head of Account to which the Loss is debitable may be informed

Signature of Head of Office with seal

NoteA copy of this report is to be sent to AGMPThis is as per M P Finance Code Vol I

28

STORAGE AND STOCK MANAGEMENT

29

Foreword

The New Drug Policy 2009 is being implemented in the State of Madhya Pradesh

In order to have a proper procedure for Storage maintenance and expiry management of the drugs it is necessary to follow Good Storage Practices with Standard Modules for pharmacistStore keepers

Proper guidelines on Storage Practices can lead to better Stores and inventory upkeep with medicines being properly stored in racks with proper cleanliness and hygiene

This is a step towards storage maintenance and expiry management at the various stores in the state Looking forward to see that the heads of all health facilities take benefit from this module

D ir e c t o r M e d i c a l S e r v i c e s

30

INDEX

Sr No P a r t i c u l a r s P a g e

1 S T O R A G E A N D S T O C K M A N A G E M E N T 4

1 Quarantine and checking of stocks 11 Quarantine area 12 Checks to be carried out on new stocks

2 S t o r a g e 21 Need for proper storage 22 Different patterns of storage 23 Different means of storage 24 Temperatureclimatic conditions 25 Special storage of supplies 26 Storage and stability of medicines

3 Stock Control and Expiry Monitoring 31 Stock control 32 Stock rotation and expi r y m o n i t o r i n g

4 Other aspects of storage 41 Design of a storage area 42 Cleaning and maintenance 43 Product recalls 44 Returned goods

2 A p p e n d i x 1 Templates of letters for use if found not of Standard Quality [Frozen and expired goods ]

Frozen Drugs-ordered to return to the Suppliers-reg(New drug policy 2009)

Frozen Drugs-ordered to return to the Suppliers- for issue of gate pass after verification reg(New drug policy 2009) Stop instruction-reg(New drug policy

2009) Appendix II Material handling in drug stores

31

3 PROCUREMENT ndash Government Order Relating to

the Management of Stores

(Reproduced for reference material on basic

procedure in decentralized system followed by

Health facilities in 1977)

54

F L O W C H A R T S f o r a BI R D S E Y E V I E W o f

P R O C U R E M E N T

5 5

ACQUISITION OF STORES 6 1

PLACING OF ORDERS 6 2

RECEIPT OF STORES 6 2

CUSTODY 6 3

ISSUE OF STORES Maintenance of Stock Books

6 3

PROCEDURE OF INDENTING FOR WARD amp OTHER SECTIONS OF THE INSTITUTION

6 4

HOW OFTEN TO INDENT 6 5

EMERGENT INDENT 6 5

HOW TO INDENT 6 5

KEEPING OF RECORDS IN WARDS A N D S E C T I O N S

6 6

ACCOUNTABILITY OF DRUGS BROUGHT BY THE PATIENT OR RECEIVED IN DON A T I O N BY T H E WARDSECTION _IN - CHARGE

6 7

RESPONSIBILITY OF STORES AT VARIOUS LEVELS

6 7

DISTRIBUTION OF MEDICINES FROM OUTDOOR DEPARTMENT

6 7

LOSS BREAKAGE DAMAGE ETC 6 8

PROCEDURE FOR WRITING OFF STORES 6 9

DISPOSAL OF WRITTEN OFF ARTICLES 7 1

FORMATS TO BE USED 7 3 - 81

32

STORAGE AND STOCK MANAGEMENT The expiry periods of pharmaceutical products have meaning only if the products are stored under proper conditions otherwise products are likely to lose their potency before the actual date of expiry

A pharmacist is a vital link in the distribution chain for pharmaceutical products The medicinal products remain for a long period during the distribution cycle at the wholesaler and at retail pharmacies It is therefore very important to maintain proper storage conditions in these units

Every community pharmacy however large or s mall needs to store and manage its medicine stocks effectively There must be systems to ensure

middot bullbull Secure storage middot bullbull Clean and correct environmental conditions during storage middot bullbull Accurate and effective record keeping middot bullbull Effective stock rotation and expiry monitoring middot bullbull Effective fire and theft prevention middot bullbull Effective rodent pest control

For easier un derstanding this module has been divided into the following sections

1 Quarantine and checking of stocks 11 Quarantine area 12 Checks to be carried out on new stocks

2 S t o r a g e 21 Need for proper storage 22 Different patterns of storage 23 Different means of storage 24 Temperatureclimatic conditions 25 Special storage of supplies 26 Storage and stability of medicines

3 Stock Control and Expiry Monitoring 31 Stock control 3 2 S t o c k r o t a t i o n a n d e x p i r y m o n i t o r i n g

4 Other aspects of s t o r a g e 41 Design of a storage area 42 Cleaning and maintenance 43 Product recalls 44 Returned goods

33

1 QUARANTINE AND CHECKING OF STOCKS

11 Quarantine Area D r u g S t o r e pharmacies receive stoc k s f r o m su pplie r s a c c or d ing to pur c h a se o r d e r s T he stock that is received must be visually checked for quality and quantity The stocks must be kept in a separate area until the checking is done to avoid intermixing with existing stock This necessitates the presence of a separate area within the pharmacy w h e r e i n t h e storage and other checking of stocks can be performed This area is called the QUARANTINE AREA This area should be marked and identified adequately to distinguish it from other areas

The area may be marked using different means 1 ) A s m a l l board saying Quarantine on a separate table used exclusively if it is in the middle 2) A board on the wall if the table on which the quarantine stock is placed is against the wall

middot Stock received from wholesalers should be immediately transferred t o t h e Quarantine Area

middot In the Quarantine area the stock may be stored on racks shelves or in cupboards to prevent ingress of moisture dirt and other contaminants

middot Regular stocks from the pharmacy should not be left kept in the quarantine area Special care has to be taken in case of refrigerated medicines supplied by the suppliers so tha t the y do not remain in the quarantine area for long periods of time They should be immediately checked on receipt and transferred to areas for refrigerated storage s o a s to maintain the cold chain bull

Advantages of having a separate Quarantine Area middot Avoids cross mixing of newly arrived stock from existing stock till it is checked middot Lays stress on checking the quality of the stock received middot S to ck checking ensures t hat defective andor expired goods do not enter the storage areas

34

bullbull

bullbull

12 Checks to be carried out on new stock

Unpacking and checking stock

Supplies received should be unpacked and checked in the quarantine area Staff doing the checks should be adequatel y trained in what they have to check when stock arrives

Checking should be seen not simply as counting the units received but as a part of the quality assurance system bullThis should include middot Visually inspecting the packaging middot Checking the integrity of containers middot V erifying the completeness and leg ibility of la b e ls ( a ppr o ve d dr u g name strength any special storage instructions and expiry date)

bull

The expiry dat e should be checked to ensure that there is adequate shelf life remaining

Supplies should be individually checked using a checklist 35

Checklists

36

The wholesaler supplying the product should be notified immediately in case of any discrepancies ( and the details should be recorded in a register) and sent in a written format to the supplier It should include middot Missing boxes or cartons middot O p en tampered boxes or cartons middot Missing supplies middot Differences in the actual quantity and the quantity shown on the packing middot Additional medicines that had not been ordered but have been supplied middot D a m a g e d b r o k e n o r p oor quality medicines middot Any other discrepancies

The purchase invoices are an important aspect to be considered The invoiced documents should be signed and filed for reference as per the Drugs and Cosmetics Act and retained for at least 3years

If the wholesaler supplies medicines as an emergency without a bill or against a delivery challan

middot The supplies should be checked for integrity and inspected for damage middot The details of supplies received should be recorded middot The supplier should be asked t o send the bill as early as possible middot When the bill is received it should be checked against the details recorded and anomalies if any should be reported to the supplier

To keep a track of the received stock maintaining a S t o c k R e c o r d C a r d c a n b e very useful The entries in the stock record card can be made while checking the stock received STOCK BIN in the stores should have Stock record card

Maintaining a stock card for every product may not be very practical for a retail pharmacy however it could be maintained for costly medicines Nowadays it is much more practical and easier to maintain records using computers

The pharmacist should ensure that medicines manufacturedmarketed by a company are received only through an authorized distribution network of that company This is important to prevent spurious and counterfeit drugs from entering the pharmacy

37

2 STORAGE 21 The need for proper storage The storage of medicines and other products is an important requirement of Good Pharmacy Pr actice Appropriate storage of medicines is essential -

middot bullTo ensure that the potency is maintained middot bullTo prevent deteriorationspoilagedegradation middot bullTo ensuremaintain physical integrity

To ascertain that the quality and safety is maintained throughout their shelf life Storage requirements need to be considered on 2 aspects

a) Integrity of medicines Medicines should be stored in such a way so as to maintain their integrity and potency middot Maintain the right temperature required middot Protect from excessive humidity middot Keep medicines away from direct sunlight middot Protect from pests and rodents

b) Physical location middot Should be easy to locate middot Accessible middot Orderlysystematically placed

2 2 D i f f e r e n t p a t t e r n s o f s t o r a g e The pharmacist could follow any of the different patterns of storage The pattern of stora ge should be selected in such a way that it facilitates speedy and efficient dispensing of medicines

The pattern of storage could vary with each pharmacy experience usual practiceroutine of staff and the person-in charge and also depending on space av ailable turnover etc (i) The medicines could be stored c o m p a n y w i s e ie the medicines manufactured by one company should be grouped together and kept in one place Within each company shelfshelves the medicines may be placed in alphabetical order for easy and quick placement and removal Also bottles tubes boxes etc may be segregated within that shelf

38

(ii) The medicines may also be stored in a lphabe t ic al o r de r ie they are placed in order from left to right based on their name The first letter of the name is used to g r o u p t h e m e d i c i n e s t o g e t h e r a n d k e e p t h e m i n o n e l o c a t i o n I n s o m e p h a r m a c i e s a l l t h e strip packing are placed in drawers or boxes in alphabetical order each box or drawer containing strips of one particular alphabet This system ensures that the strips always remain e n c l o s e d i n t h e b o x e s d r a w e r s a n d a r e n o t e x p o s e d t o d u s t T h e d i s a d v a n t a g e i s that it might lead to mix -u p o f strips in the same drawer and it may cause a problem incase of similar looking strips in which case a wrong medicine may be dispensed Secondly cut strips lying around in the drawer may lose their identity if the batch n u m b e r andor expiry date is not seen on the cut portion of the strip

39

(iii) The medicines may be stored according to their therapeutic class ( e g a n t i b i o t i c s anti asthmatics or anti hypertensives) ie the medicines are kept together based on their pharmacological or therapeutic action

(iv) The medicines may be stockedsegregated according to dosage forms eg l i q u i d s (bottles) solid oral dosage forms eye drops rotacaps ointments etc all stored on separate shelves

Always Remember I Storage of prescription medicines should preferably be separate from OTC medicines OTC medicines especially those that a r e a d v e r t i s e d m a y b e d i s p l a y e d f o r c l i e n t s t o select or to ask questions about [OTC-O v e r t h e c o u n t e r ] II Storage according to temperatures is a must no matter which pattern of storage is followed Also within a particular storage area segregated storage may be maintained In a refrigerator for example medicines may be stored in trays racks and the freezer according to the temperature required

40

Whatever pattern of storage is selected all the personnel should ensure that middot The stocks are stored in an orderly manner middot The medicines are kept back in the same place from where they were removed middot All medicines are arranged neatly once in a while

middot The personnel should be careful while storing the medicines middot They should not throw the medicines haphazardly 23 Different means of storage

middot Within each temperature and security zone medicines must be stored so that they are easily accessible and protected against damage

middot Basic means of storage include shelves racks and drawers middot To prevent dust from entering the shelvesracks it is ideal to have glass

shutterssliding glass doors This can however be disadvantageous because accessibilityspeed is hampered in removing a product from the shelf because the glassshuttersliding glass has to be

41

opened m o v e d e v e r y t i m e a p r o d u c t h a s t o b e p i c k e d u p U s e o f a i r c o n d i t i o n e r s f o r t h e p h arm acy with a closed door at the e n t r a n c e o r a n a i r c u r t a i n c a n r e d u c e t h e d u s t problem In such cases the shelvesracks may be left o p e n

bull

middot Direct storage of cartons on the floor should be avoided because besides being an unhealthy practice the contents may also be damaged by moisture bull

middot Store medicines preferably in shelves with glass shutters for visibility middot Closed shelves further prevent dust from going in especially in India where most

pharmacies are located along busy roads middot Some medicines have to be refrigerated or stored in a cool or cold place Having a

refrigerator or two (as per the need of the pharmacy) is essential to store suc h medicines at temperatures mentioned on the label bull

42

Refrigeration middot All cold chain equipment should meet required standards middot Improvement in refrigeration technology has provided frost -free refrigerators

Pharmacists should opt for frost-free refrigerators as they are easy to maintain and protect printed packaging materials Conventional refrigerators may cause water falling from trays below the freezer on medicines stored in the refrigerator thus causing soggy labels

middot bull Frost-free refrigerators also provide separate and large compartments for the freezer portion (required for storing medicines needing sub-z e r o t e m p e r a t u r e ) and the main storage area with separate doors so that opening one door does not disturb the storage temperature in the other compartment

Care should be taken to keep the refrigerator on 24 hours a day It should not be switched off after working hours It is advisable to have an inverter connected to the refrigerator so that the refrigerator re mains working even when there is a power outage

middot The refrigerator door should be closed tightly middot The refrigerator door should not be left open for too long middot Space should be left between medicines stored in a refrigerator to allow air to

circulate middot The ref rigerator should be placed about an arms length away from the wall

This will increase air circulation thus not affecting the cooling within the refrigerator

middot Vaccines should not be stored on refrigerator door shelves as they are exposed to warmer temperatures each time the door is opened Vaccines should always be stored on the middle shelves of the refrigerator

middot Refrigerated medicines should not be left out of the refrigerator for more than a few minutes

43

middot Consumable products like juices energy drinks e t c s h o u l d n o t b e s t o r e d a l o n g with medicines in refrigerators If required they may be kept in a separate refrigerator

middot An adequate number of refrigerators should be planned to store the entire stocks requiring refrigerated storage

middot Adequate procedures should be followed for defrosting cleaning and maintenance of refrigerators

middot Icefreeze packs should be kept in the freezer compartment so that they can be used for transporting cold temperature medicines The packs can be given to clients along with the medicines requiring cold temperature storage so that the temperature is maintained till the client reaches home and can then put the medicines in a refrigerator) Freezer packs can also be used to keep medicines temporarily in case there is a power outage or refrigerator breakdown

Activity

Prepare a SOP (Standard operating procedure chart) for cleaning a refrigerator Discuss it with your staff finalize its maintenance once a month through AMC -A n n u a l Maintenance contract CMC - Comprehensive maintenance contract and put it up on the pharmacy refrigerator Put the Purchase Order details name of manufacturer Phone of Service Engineer and a register to login the Machine service and down timeService reports may be maintained properly

Refrigerator monitoring and maintenance

middot bullIt is important to carry out routine monitoring and maintenance of the refrigerators and to organize an effective repair system

middot bullThe temperature in the refrigerator must be monitored and recorded routinely at least once a day

middot Any breakdown must be reco rded including the period during which the medicines were exposed to uncontrolled temperatures Medicines may then be kept or discarded depending on the problem guidelines or the manufacturers advice

middot Cold chain monitor cards and devices in or on packages that change color or otherwise alert staff to potential damage assist in monitoring (These are likely to be introduced in India soon)

middot It is essential to have a contingency plan in place before a refrigerator breaks down An arrangement can be made to move the contents to a private refrigerator elsewhere in the community or to obtain a regular supply of ice packs until the defect is rectified

Put filled water bottles in the bottom half of the refrigerator door in order to provide cooling in the refri g e r a t o r w h e n t h e r e i s a p o w e r o u t a g e T h i s m i g h t t a k e c a r e o f t h e temperature when there is no current for a couple of hours If the power outage is expected to last for several hours special arrangements such as an inverter UPS have to be made to keep the refrigerator constantly running in the absence of electricity middot Defrost the refrigerator in case of excessive ice formation and preferably at regular

intervals Keep a record of the same

44

2 4 T e m p e r a t u r e c l i m a t i c c o n d i t i o n s

i) Temperature control middot The medicines in a pharmacy need to be stored at appropriate temperatures to

maintain their stability middot An air-conditioned environment where temperature can be controlled is

recommended for pharmacies Air conditioning offers the option of setting the t e m p e rature as per requirements

middot bullIt is ideal to have an air conditioner to maintain the temperature below 25 C as most medicines require storage below this temperature Secondly this temperature is pleasing to both the staff and the visiting customers too

middot In the absence of an air conditioner circulating fans may be used middot This need is felt even more in certain parts of India where temperatures soar above 45

C and some areas where it falls to sub zero temperatures In such cases temperature maintenance is essential to prevent deterioration of medicines due to unnecessary exposure to drastic temperature fluctuations

middot This need is felt even more in certain parts of India where temperatures soar above 45 C and some areas where it falls to sub zero temperat u r e s I n s u c h c a s e s temperature maintenance is essential to prevent deterioration of medicines due to unnecessary exposure to drastic temperature fluctuations

i i ) Humidity or moisture control Moisture or humidity can adversely affect the stability of me dicines such as tablets capsules powders

45

Gelatin capsules become soft and swell on absorption of moisture The drug content of tablets may undergo surface hydrolysis The presence of moisture may encourage the growth of microbes It is therefore essential to control humidity

To reduce the effect of humidity the following suggestions may be followed -middot Open the windows to allow air circulation Use a fan to circulate fresh (outside) air middot In humid climate a dehumidifier is useful for preventing mo i s t u r e d a m a g e ( i n t h e absence of an air conditioner) middot For bulk containers of tabletscapsules do not keep the container open for a long time and replace the lid or closure immediately after taking out the required number of medicines for dispensing middot Do not allow the medicines to touch the floor or the walls The walls may be damp and may cause moisture absorption damaging the product

middot Calibrated thermometers and manometers can be used to detect temperature and humidity in the pharmacy

middot Periodici t y of checking the temperature should be fixed middot The climatic conditions should be recorded and documented middot Temperature charts should be available for ready reference

Documentation is one of the core activities for achieving and maintaining quality It is one of the most essential components of validation Temperatures in various areas

46

including refrigerators should be recorded at a predetermined periodicity usually daily at the hottest time of the day and such documents should be preserved i i i ) Storage conditions A number of storage conditions are mentioned on the labels of medicinal products These conditions have to be properly interpreted and appropriately complied with

According to the Drugs and Cosmetics Rules 1945

1 The term cool place means a place having a temperature between 10 C and 25 C

2 The term cold place means a place having a temperature not exceeding 8 C In case of storage conditions for specific products please refer to Schedule P The Drugs and Cosmetic Rules 1 9 4 5

The Indian Pharmacopoeia specifies the following storage conditions -

Wherever the condition for storage is not specified medicines may be stored under normal temperature In a country like India however where normal temperatures soar to h i gh temperatures it is recommended that medicines be stored in a cool place

Activity Prepare a list of the storage requirements mentioned on the label of about 20 products in your pharmacy and check if the temperature is maintained

47

25 Special Storage o f s u p p l i e s If the product has no special instructions normal storage conditions apply This means storage in dry clean w e l l -ventilated premises at temperatures of +15 C to +25 C or depending on the climate up to +30 C (WHO1990) Storage instructions are product specific Different brands of the same generic drug may have different storage requirements as they may have different packaging or formulations It is essential to follow the product manufacturers storage instructions to the maximum extent possible Less stable medicines must be stored in specific conditions to maintain their quality or potency

The following products require special storage facilities

middot Products that must be kept frozen (usually vaccines and sera) middot Products sensitive to h eat an d r e q uir in g r e f r ig e r a tio n ( +2 C to +8 C) middot Products that have reduced shelf life at uncontrolled room temperature and need

mechanical ventilation or air conditioning middot Flammable products that require separate fireproof premises middot Products prone to theft o r m i s u s e

Products needing storage in a controlled environment -

The usable shelf life of the following products may be reduced if stored at uncontrolled humidity or at room temperature in hot climates -

middot Some injectables (eg adrenaline) Most injectable preparations are less stable than solid oral forms (tablets and capsules) Injectable preparations in solution are particularly unstable Many injections must be protected from light as well as heat

middot Intravenous fluids (particularly if packed in p lastic containers) middot Some suppositories pessaries creams and ointments These products may melt at

temperatures greater than 30 C Once this happens it is not advisable to use them because the active ingredient in the formula may get unevenly distributed

middot Products containing rubber latex cellulose or some plastics Condoms most sterile disposable medical devices and surgical products such as syringes needles and catheters require protection from excessive humidity and strong light and heat Any o f these conditions may make products brittle stained amp unusable Sterility cannot be assumed if packaging is damaged

In hot climates these products should be stored in the coolest place possible preferably with air conditioning or air circulation fans

48

Products needing freezing or refrigeration-middot Vaccines blood products and many other medicines lose potency if kept even for a

brief period at temperatures outside the recommended range For these products the cold chain must be maintained at every stage of the distribution system

middot Freezing is as damaging as high temperatures for some products including injectable contraceptives ergometrine insulin adrenaline and the DPT DT TT and Hepatitis B vaccines Such products therefore sho uld not be allowed to freeze (not be kept in the freezer compartment)

middot Short periods at room temperature (during transportation or local distribution for instance) may be acceptable for many products (such as ergometrine a n d i n s u l i n ) e v e n t h o u g h s u c h e x posure can to some extent reduce shelf life Other items such as vaccines should always be transported in cold boxes

Storage of insulin injections-

middot Insulin should always be stored in a refrigerator at the recommended temperature of 2 -8 C

middot Insulin should not be kept in the freezer compartment of the refrigerator middot Insulin should ideally be stored horizontally middot It should not be exposed to sunlight or excessive heat middot Insulin suspensions should not be used if the suspension cannot be properly

resuspended due to cake or clump formationbull

Controlled drugs -Narcotics (for example Pethidine injection morphine preparations) and other specified drugs that may be abused are governed by special legislation and regulations The following security measures are suggested in the pharmacy -middot A safe or reinforced double locked cabinet fitted with a light (preferably with a red

bulb) that comes on when the door is opened

49

middot A special register recording details of each receipt or issue with 2 signatures physi cal counting of medicines after each entry and signatures at handover takeover

middot Independent audit (by supervisors and drug inspectors)

Products prone to theft abuse or misuse -

Some medicinesproducts are particularly prone to theft abuse or misuse These include expensive medicines (eg insulin) certain antibiotics and products prone to abuse or misuse like psychotropics etc

Such medicinesproducts should be stored adequately They require stricter record keeping and more frequent stock taki ng than others Periodic audits should be carried out to check for consumption against actual recorded use (registers prescription records stock records etc) to expose any theft or misuse bull26 Storage and stability of medicines Medicines are not stab le indefinitely They are stable for a specific period of time sometimes for a brief period Poor storage conditions accelerate the drug degradation (decomposition) Temperature light and moisture are the most important contributing factors for drug instability It is important to identify and be aware of the potential for instability There is a need to comply with storage requirements to ensure quality medicines for patients It is also important to offer advice to patients too about appropriate storage o f medicines at home The dispensing label should state the storage condition required and be backed up by a verbal reminder especially where special storage is required bull

50

In case stability and storage problems are seen with formulations they should be reported immediately to the representative of the manufacturer and taken out of circulation till the stability problems have been resolved

The pharmacist can easily detect stability problems when products show change in appearance color odor settling of the product contents breaking of emulsions melting of creams oozing of contents from the containers and any such physical changes

3 STOCK CONTROL AND EXPIRY MONITORING 3 1 S t o c k C o n t r o l For economic reasons pharmacists do not like to have stock on their shelves for long periods of time The aim should always be to keep stock at a level that will just meet demand Normally most manufactured medicines have a long shelf life Even then it is essential that there is efficient stock rot ation so that the older stock is used first It is also a good practice to check the expiry date as an integral part of the dispensing process When short shelf life products are involved stock levels may have to be modified to prevent medicines regularl y expiring on the shelves

32 Stock rotation and expiry monitoring In order to avoid accumulation of expired and obsolete stock medicines should be stored and issued according to the following guidelines -middot The stock control system must record the ex p i r y d a t e a n d t h e d a t e o f r e c e i p t middot Stock must be stored so that earliest expiring batches are picked and issued first middot The First In First Out (FIFO) system - In this system the stock which is received

first is sold first This system however may not be useful for pharmacies because most of the stocks carry an expiry date For pharmacies the FEFO system is more practical

51

middot The First Expiry First Out (FEFO) system - In this system the stock having an earlier expiry is sold first The stock with longer shelf life should be placed farthest to the back (or at the bottom in case o f sta c k e d b oxe s) T h is is pa r tic u la r ly impor ta n t with products that have short shelf lives such as vaccines some vitamins antibiotics etc and reduces losses due to expiry

middot E x p i r y dates should be noted on the stock record upon receipt Stock nearing expiry should not be accepted unless it can be used before expiry

Computerization and expiry monitoring In the pharmacy computerization facilitates both checking stocks and expiry mo nitoring and helps-bullbullKeeping a check on products nearing expiry bullbullKeeping a check on non- moving and slow moving products bullbullTo facilitate the removal of medicines nearing expiry from shelves in time to send them back to the wholesaler or supplier

Periodic checking for expiry The expiry date for medicinal products is a critical aspect in pharmaceutical dispensing and due importance should be given to it Periodic checking for expiry of medicines will ensure that the patient will never receive products that have crossed their expiry date During periodical checking of expiry the personnel involved should remove medicines that are nearing expiry bullbullIn -house threshold periods should be set and followed for retrieval of such medicines from the shelves bullbullSuch medicines should be stored separately These should either be dispensed immediately (thus ensuring that they are used before the expiry date) o r t h e y s h o u l d b e returned to the suppliers bullbullA separate area should be designated (cupboard or shelf)marked[FROZEN ZONE] which is adequately marked EXPIRED GOODS- NOT FOR SALE to store all expired stocks FROZEN ZONE

52

Remember Expired medicines are a NATIONAL WASTE So stock only what you can sell Avoid expiries save precious medicines for the nation

Treatment and disposing of expired medicines bullbullProcedures need to be in place for the treatment of expired medicines bullbullThe expired medicines need to be collected and be sent back to the supplier or company for appropriate disposal bullbullRecords must be maintained for expired medicines and how they are disposed off bullbullIn case of medicines that are not returnable to suppliers procedures for disposal need to be followed by the pharmacy in conjunction with the FDA The following procedure can be followed if medicines cannot be returned to suppliers ( T h e b a s i c p h i l o s o p h y of appropriate disposal is to prevent their re- circulation and use) bullbullC u t t h e c o n t ainer in such a manner that the label is also cut In case of tablets and c a p s u l e s d e s t r o y them by disposing them in a bucket of water bullbullUse landfill procedures (deep burial into the ground as per stipulations of Medical Waste Disposal Act prevalent in the respective state) bullbullPour the liquids into the sink and wash away with sufficient quantity of water bullbullKeep a record of such disposal with full details of medicines destroyed Although these measures are usually adopted care has to be taken with such tr e a t m e n t a s studies have shown that flushing of medicines has resulted in tracessmall quantities of medicines being found in waterways and groundwater having potential health and environmental effects

4 O T H E R A S P E C T S 41 Design of storage areas The following important factors need to be considered in design of storage areas -middot The retail outlets in hot areas in summers should be air-conditioned Similarly in

a r e a s o f e x t r e m e c o l d t h e p r e m i s e s w o u l d r e q u i r e w a r m i n g e s p e c i a l l y i n w i n t e r s t o maintain cool temperatures The placement of air -conditioners and heating devices should be such that medicines are not directly exposed to the cold or heat

middot Due consideration should be given to storage requirements of formulations while designing shelves and cupboards in retail outlets Sufficient shelf height should be provided so that all liquid products can be stored vertically As far as possible the shelves should be covered with glass panels to protect medicines from dust and p r e v e n t r a p i d f l u c t u a t i o n s i n temperature

middot Medicines should be stored according to the storage instructions on the labels bullIt is ideal to have a door at the pharmacy entrance to prevent dust from coming in as well as reduceprevent cooled air from going out This may not however be considered feasiblepracticable by many pharmacy owners for fear that clients may not enter the pharmacy because the door may act as a barrier An air curtain is a good alternative to a door

middot There should be minimal direct sunlight falling on the products Particular consideration should be given to premises directly facing the sun

middot bullThe arrangement of lighting in the interior of the premises should also be in a manner that the lights are not focused on the products It has been shown that light causes not only chemical damage but also can catalyze physical changes like moisture uptak e by the products Care should be taken to ensure that only diffused light falls on them

53

middot As far as possible provision should be made for a temperature and humidity indicator device in a pharmacy These devices are now easily available

middot Stability studies o f m e d i c i n e s p a c k e d i n b l i s t e r s h a v e r e v e a l e d t h a t i f t h e s e a r e exposed to light they tend to absorb moisture It is therefore necessary to store them in suitable cartons so that the blisters are not exposed to light Pharmacists should do this even if the manufacturer has not provided cartons

middot Light and temperature sensitive products should not be stored on counters where the light is intense or direct and there is no protection from temperature and humidity

42 Cleaning and maintenance i) Cleaning of storage areas

The storage areas of the pharmacy should be cleaned periodically and cleanliness should be maintained at all times The Standard Operating Procedure for cleaning should be designed and followed accordingly Schedules for cleanups should be laid down and adequate cleaning equipment should be made available

Tips for maintaining cleanliness middot Provide clean pieces of cloth for wiping at various locations in the pharmacy

Replace with clean cloth at regular intervals middot Keep separate pieces of cloth for floors shelves and medicines middot Use a disinfectant andor soap solution to clean floors middot Ensure removal of dust and prevent accumulation of dirt middot Ensure removal of cobwebs middot Use a vacuum cleaner for cleaning areas not easily reachable middot T a k e c a r e t h at breakages are handled and cleared effectively middot Observe the factors leading to waste generation in the pharmacy and take appropriate

measures to tackle the problem middot Record all cleaning procedures performed and maintain all the documents required

For ex a m p l e -bullbullThe floor of the pharmacy may be swept with a broom and swabbed with soap water every morning bullbullThe floor may be swabbed with a disinfectant every week bullbullThe entire premises including shelves and cupboards may be cleaned with a cloth (to remove dust and to check for medicines approaching expiry date or expired medicines) every three months bullbullAll the steps followed should be r e c o r d e d

The floor shelves drawers have to be cleaned and a check should be kept on dust cobwebs spillages due to breakage etc It is therefore essential to have SOPs for cleaning laying down cleaning frequencies allotting responsibilities and maintaining a daily record in the logbook to document all these activities

54

While cleaning dust settled on dosage forms like bottles tubes etc should be removed Before dispensing the products should also be wiped to remove any dust settled during storage

For refrigerators bullbullDefrosting and cleaning should be done at regular intervals bullbullSwitch off the refrigerator while cleaning bullbullCleaning should be done quickly and stocks put back immediately

i i ) Pest control Pests are a serious problem in India where insects reptiles and rodents (eg cockroaches l i z a r d s r a t s s i l v e r f i s h (Deemak - in Hindi ) etc) may find access to the pharmacy storage areas Insects like ants and borer ants may often attack wood in the pharmacy causing d am ag e to shelves cupboardsPest c ontr o l in a p h a r m a c y c a n b e a d i f f i c u l t t a s k b u t t o avoid possible contamination and physical damage to stock it is necessary to keep pests out of the pharmacy premisesPest control measures should be implemented with proper p r e c a u t i o n s t a k i n g u t m o s t c a r e t o a v o i d contamination of medicines

55

Th e following pest control measures c a n be ta ke n f r om tim e to tim e -bullbullRat bait and traps can be placed at various locations bullbullInsecticutors can be used on a permanent basis bullbullInsecticidal sprays and repellants can be used from time to time

i i i ) Fire precautions

Combustible trash such as cartons boxes and other packing waste must not be allowed to accumulate in the store Waste should be deposited in appropriate waste bins and be d i s p o s e d o f f o n a d a i l y b a s i s

F i re detection and fire fighting equipment must be maintained and regularly inspected The pharmacy personnel should receive adequate training in fire fighting techniques and emergency actionFire prevention measures should include a prominently displayed ldquoNoSmokingrdquo sign careful handling and disposal of combustible waste materials and checking of electrical connections at regular intervals

iv) Security middot Doors shutters of the pharmacy should be strong and be fitted with secure locks middot Counters should be designed so that unauthorized personnelclients do not have

access to areas where prescription medicines are stored Access to such areas should be restricted to the pharmacy staff

middot All the pharmacy staff handling supplies should be accountable for their ac t i o n s

56

middot bullSpecial care must be taken in case of Schedule X and manufactured drugs (under NDPS Act) Such medicines should be kept under lock and key and the key should be kept with the Chief Pharmacist or i n h i s a b s e n c e t h e s e n i o r p h a r m a c i s t

v) Breakagespillage and damaged product Products that have been damagedspoiled during storage and handling spillages and broken glassware should be disposed off according to procedures laid down by the pharmacy Broken and damaged products s h o u l d b e p l a c e d i n a segregated area to be returned to the supplier

vi) Inspection Senior staff should inspect all pharmacy areas regularly The shelves and drawers should b e c h e c k e d d a i l y f o r signs of pests and dust Ceiling and walls should be checked for dirt and cobwebs Stock should be checked on a regular basis for deterioration due to climatic conditions

43 Product recalls Products found to be defective should be quickly recalled (withdrawn from the market) The instructions are generally issued either by the manufacturer or the regulatory agency The level of recall is determined by both the degree of risk and the extent of distribution of the product and in India is mainly directed at the distribution chain

On receiving the details of the defective substandard spurious batchbatches of a medicine to be recalled from the manufacturer or the stockist or the FDA the pharmacy should immediately check if the particular b a t c h i s i n s t o c k a n d i f s o s u s p e n d i t s s a l e immediately

Similarly if the regulatory authority in the country bans a particular medicine or FDC the pharmacy should immediately check and remove all the different brands of that particular medicine under consideration

The details of medicines and their batches to be recalled should be available in the q u a r a n t i n e a r e a w h e r e stocks are received and checked This is to ensure that such medicines do not come into the pharmacy

middot The pharmacy should develop SOPs for recall of medicines middot The pharmacy staff should be immediately informed about such medicines and

the details should be displayed in writing in a prominent place in the pharmacy middot Rapid action helps avoid unnecessary exposure to such medicines once the

problem has been d e t e c t e d middot The progress of the recall procedure in the pharmacy should be monitored every

few days to ensure complete compliance middot All stocks of the recalled products should be stored separately from the saleable

stock These can be stored in the expiry cupboard segregated from the expired goods and be appropriately labeled ldquoRecal l e d G o o d s - Not for Salerdquo

The supplier should be notified and asked to replace defective products middot All the details of the procedures followed should be duly recorded in a Recall

Register maintained specially for the purpose The register should include d etails such as -middot Date of the recall middot Nam e of the product

57

bullbull

middot Details of the product (name of manufacturer batch number expiry date) middot Nu m b er of units purchased sold a n d sto c k in ha nd middot Reason for recall middot Nam e of the supplier to whom produc ts w e r e returned along with the date and quantity middot Name and signature of the designated personnel carrying out the recall procedure and recording details middot Name and signature of the chief pharmacist verifying the recall procedures and recording details 4 4 Returned medicines

Medicines may be returned to the pharmacy by clients due to the following reasons -bull

bullbull Unused medicines bullbull Course not completed bullbull Therapy changed by doctor bullbull Side effects experienced by patient bull

bullbull DamagedDefective medicines bullbull Missing or defaced label bullbull Missing tablets in a stripblister bullbull Leakage in bottles bullbull Leakage in strips bull

bullbull Expired medicines

Appropriate SOPs should be framed and followed for their acceptancerefusal and disposal middot bull For unused medicines returned by clients the p harmacy personnel should verify

that these were purchased from their pharmacy They should then be checked for integrity of the packing the dosage form and the expiry date and verified with the client whether they were stored in appropriate conditions This again is at the discretion of each pharmacy

middot The damageddefective medicines returned to the pharmacy should be taken back and stored separately Existing stock of the same product should be checked for similar defects

middot Expired medicines should be accepted from clients at the discretion of the pharmacist and be immediately shifted to the expired goods cupboard These can be stored segregated from the pharmacys own expired goods and be appropriately labelled ldquoExpired Goods returned by clients- Not For Salerdquo

It is advisable not to accept returned medicines requiring cold chain storage (refrigeration) because it cannot be ensured that the cold chain was maintained when the medicines were in the hands of the patientclient middot Appropriate adjustments in t he stocks should be made for medicines

returnedexchanged to update the inventory middot The medicines should then be returned to the respective shelves middot A lsquoReturned Goodsrsquo register needs to be maintained to record all details of returned

medicines

R egister should include such details as-

58

middot N a m e o f t h e p a t i e n t middot Nam e of the product and quantity r e tu r n e d middot Product details such as the batch number and expiry date middot Condition in which received middot Reason for returning products middot Compensatory measures taken wi t h r e s p e c t t o c l i e n t middot Action taken with respect to product middot Name and signature of the personnel accepting the returned medicines and recording details middot Name and signature of the chief pharmacist verifying the recorded details

What the pharmacist would have learnt from this module The storage of medicines is a critical factor in the distribution cycle bullbull Stocks received by the pharmacy should be quarantined in a separate area and necessary checks s h o u ld be performed to ascertain the qua lity a nd quantity of stocks received bullbull Whatever pattern and means of storage used the products should be stored so as to maintain their potency and integrity bullbull Storage conditions should be monitored and maintained on a regular basis bullbull Optimum stock levels should be maintained and regularly monitored for expiry bullbull The design of storage areas should facilitate appropriate storage of medicines bullbull Cleanliness should be maintained in the pharmacy bullbull Adequate measures should be taken in case of returned medicines and recalled products

Optimum storage of medicines is mandatory whether at the distribution stage at the pharmacy or ultimately within the homes of patients The pharmacist has an important r o l e t o p l a y i n t h e s t o r a g e o f m e d i c i n e s i n m a i n t a i n i n g d r u g p o t ency and efficacy and thus facilitating optimum therapeutic benefits Good Pharmacy Practice - IPA -CDSCO - WHO Appendix I Quality Assurance Templates of letters for use if found not of Standard Quality [Frozen and expired goods ]

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated To Name of the Supplier with address

Sub Not of Standard Quality GoMP-Supply of Drugs and medicines-(Codename) Return of Stocks to the Suppliers-reg(New drug policy 2009) Previous letterinvoice ref Sl No Drug Code Drug name

Manufacturing date Expiry date

Supplier address

B a t c h n o

The above items of PO nodated was drawn by the Drug Inspector (Place) on (______________date) as a statutory sampling and declared ldquoNot of Standard

59

Qualityrdquo on -(______________date) by the Government Analyst for the following reasons

- ldquoThe product sample do not confirm to IP specification for (Drug codename with respect to the content of drugrdquo

- ldquoThe product has already been blacklisted by TNMSC on -(______________date) for the failure of (quantity) of batches of drug codenamerdquo

As per the clause of the te nde r d oc um e nt ldquo I f the sa mple s d o not c onf o r m to statutory standardsthe tenderer will be liable for relevant action under the existing laws and the entire stock in such batch should be taken back by the tenderer within a period of 30 days o f t h e r e c e i p t o f t h e l e t t e r f r o m t h e v e n u e

The stock shall be taken back at the expenses of the tendererthe Procurement Authority have the right to destroy such Not of Standard Quality if the tenderer does not take back the goods within the stipulated time

The Procuring Authority will arrange to destroy the Not of Standard Quality drugs within 90 days after the expiry of 30 days mentioned above without further notice and shall also collect demurrage charges calculated at the rate of 2 per week on the value of the drugs rejected till such destructionrdquo

Hence we regret to inform you that you will have to take back the stocks available of the abovesaid batch at your own cost from the drug stores where you have supplied the above batch

Kindly acknowledge the receipt of this reference at once

P r o c u r e m e n t A u t h o r i t y Seal and Stamp

Copy to Ref No dated

1 ) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated13082010

To

Sub Frozen Drugs-ordered to return to the Suppliers-reg(New drug policy 2009) Previous letterinvoice ref

The following products which were earlier frozen have now been ordered to return to suppliers directly with permission from the State drug Authority In this regard the suppliers have been instructed to take back their failed batch from the drug store of the stores Hence you are now instructed to return the following failed batches to the suppliers by obtaining proper authorization letter and acknowledgements from them

60

Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

Kindly acknowledge the receipt of this reference at once

Procurement Authority Seal and Stamp

Copy to

Ref No dated 2) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated14092010

To

Sub Frozen Drugs-ordered to return to the Suppliers- for issue of gate pass after verification reg(New drug policy 2009) Previous letterinvoice ref

The following products which were earlier frozen have now been released Hence they may be issued Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

Kindly acknowledge the receipt of this reference at once

Procurement Authority Seal and Stamp

Copy to

61

Ref No dated 3) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated

To

Sub Stop instruction-reg(New drug policy 2009) Previous letterinvoice ref

Until further instructions stop issue all the batches of the following item Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

You must intimate the available stock in the stores of the said batch Number to the Procurement Authority immediately Also retrieve quantity if already issued

Procurement Authority Seal and Stamp

Copy to

Ref No dated 4) HOD Procurement Office of

62

Appendix II Material handling in drug stores

Rack approx rates and dimensions

S No

Item Description UOM Approx Rate

1 MEDIUM DUTY RACK SIZE 2900 H X 3090 W X 800 D IN MM (AS PER SPECIFICATION)

Each 2499800

2 MEDIUM DUTY RACK ADD ON UNIT FOR SIZE OF SR NO2

Each 2243100

To locate a Box no 3 Rack no 14 in row3

SAMPLE OF RACK no Bin numbering -------------- S a y R K 1 4 R o w 3 B o x 1 6

SAMPLE LAYOUT of RACKS in a Drug Stores

63

Sample of another warehouse of distribution warehouse system

64

65

Slotted Angle racks with bin cards

66

Plastic Pallets

Plastic pallets ar e l i g h t w e i g h t l o w- c ost and exceed industry standards for strength and durability

NOTE A pallet has bottom deckboards (see sketch) A skid does not have bottom

67

deckboards

Battery Operated Stacker

Electric Stacker Ehh (Manual Push Type) - Manual drive - Lifting electrically with Battery 12 V 88 Ah - For loading and un-loading of trucks - Battery and loading device built - in - Battery charge gauge and charging current gauge Simple and Easy Operation - Lifting and Lowering electrically direct on steering arm - Pulling and pushing through steering arm - Electrically operated relief valve on hydraulic aggregate Safe Operation - Emergency Off Switch - Constant lowering speed - Protection through lowering brake valve - Overload protection through overload brake valve - Load chains covered preventing pinching threat - Electrically interlocking during loading process - Secured battery compartment opens upwardly - Stable buffering of the steering arm in upright position - In accordance with EWG Guidelines 89 240 - In accordance with VBG 12b Prevention of Accidents

Pallet Truck [ Top ]

68

----------------------------------------------------------------------------------------------------------------------------

For Transport Of All Goods On Pallets Safe and Easy Operation - through single hand operation Lifting moving

lowering with steering handle - neutral position of the hydraulic possible - overload pressure relief valve Long Service Life - robust co n s t r u c t i o n

- special hardened axles - hardened chromium plated ram - maintenance free Easy Maneuverability - through rubber steering rollers - nylon fork rollers

A h a n d t r o l l e y

69

Trolley with plastic bins for several items del ivery

70

Digital Weighing balances

Balances amp Scales EF Seriers Precision Electronic Balance

71

1

Ice lined Refrigerators

600 litres refrigrator

72

Walk in cooler

vacuum cleaner

73

Annexure B Issue Voucher No (printed number)

Supplied to Wardsection Date

Indent no

Serial no Name of Article Quantity in Stock

Quantity required SB No

Stores-in MO Resident in Sign of charge charge WardSection

NurseCompounder Prepared by Recd Approved by by

Note-Indenting Officer to sign and affix seal with name and designation below the last item to avoid additions in one strokeno issues to be made by storesif Issue vouchers of previous Indent has not been

returned back 1st copy-Stores 2nd copy -Wardsection3rd copy-Tobe reurned to sores with Stock book entries

21

Annexure C

STOCK REGISTER FOR DEAD STOCKS

SERIAL NO DATE OF RECEIPT

Article with description

No of pieces Cost Details of

Bill Signature No Disposed

Date of disposal

Manner of Disposal

with Authority

Value realised Signature

1 2 3 4 5 6 7 8 9 10 11 12

P r e p a r e d B y C h e c k e d b y A p p r o v e d b y

Date Designation Name of Institution

22

Annexure D

STOCK REGISTER FOR EXPENDABLE ITEMS Name of article

Date

From where

received with cost

Quantity Signature To whom issued Quantity Balance Signature

1 2 3 4 5 6 7 8

23

Annexure E

Receipt amp Issue Register for WARDSSECTIONS (one or more pages as per requiremnt for each medicine)

NAME OF MEDICINE RECEIPT ISSUE

DATE Quantity In Stock

Date of

Issue

Issued toMention Bed no amp

quantity (in bracket) (For

Outdoor cases give Regd No)

Balance Signature

24

Annexure -F

OUTDOOR FREE MEDICINE SLIP In Duplicate

Name of Patient Registered No Date

Sr no Name of Medicine Quantity

Seal amp sign of doctor

25

Annexure-G

TREATMENT CARD

WARD NO

NAME OF PATIENT BED NO DATE amp TIME OF ADMISSION DATE amp TIME OF DISCHARGE

DATE MEDICINES PRESCRIBED SIGNATURE

26

ANNEXURE -H

PROFORMA FOR BREAKAGE amp LOSS

NAME OF OFFICEINSTITUTION DATE PLACE

SRNO NAME amp

DESCRIPTION OF ARTICLE

COST DATE OF PURCHASE

REASON CAUSE OF BREAKAGE

RECOMMENDATION OF INVESTIGATING AUTHORITY

Signature

Orders of the Competent Authority

Signature

27

Annexure ndash I Loss- Procedure for Reporting

1 The exact nature of the defalcation 2 The full extent of loss 3 The actual period covered by the defalcation 4 The defects in the negle c t o f r u le s by w hic h the loss was rendered possible

and circumstances which facilitated the defalcation 5 The names of the officials held personally or technically directly or

indirectly and wholly or partially responsible for the irregularity c o m m i t t e d i n t h e c a s e

6 Whether the c a s e a s b e e n J u d i c i a l l y t r i e d i n a c o u r t o r n o t i f s o c o p i e s ( i n duplicate) of the Judgment may please be furnished Copy of police report may also be furnished

7 The remedial measures adopted as safeguards against the losses hereafter 8 The prospects of re covery of the loss and he action taken to effect

recovery together with the amount recovered 9 Head of Account to which the Loss is debitable may be informed

Signature of Head of Office with seal

NoteA copy of this report is to be sent to AGMPThis is as per M P Finance Code Vol I

28

STORAGE AND STOCK MANAGEMENT

29

Foreword

The New Drug Policy 2009 is being implemented in the State of Madhya Pradesh

In order to have a proper procedure for Storage maintenance and expiry management of the drugs it is necessary to follow Good Storage Practices with Standard Modules for pharmacistStore keepers

Proper guidelines on Storage Practices can lead to better Stores and inventory upkeep with medicines being properly stored in racks with proper cleanliness and hygiene

This is a step towards storage maintenance and expiry management at the various stores in the state Looking forward to see that the heads of all health facilities take benefit from this module

D ir e c t o r M e d i c a l S e r v i c e s

30

INDEX

Sr No P a r t i c u l a r s P a g e

1 S T O R A G E A N D S T O C K M A N A G E M E N T 4

1 Quarantine and checking of stocks 11 Quarantine area 12 Checks to be carried out on new stocks

2 S t o r a g e 21 Need for proper storage 22 Different patterns of storage 23 Different means of storage 24 Temperatureclimatic conditions 25 Special storage of supplies 26 Storage and stability of medicines

3 Stock Control and Expiry Monitoring 31 Stock control 32 Stock rotation and expi r y m o n i t o r i n g

4 Other aspects of storage 41 Design of a storage area 42 Cleaning and maintenance 43 Product recalls 44 Returned goods

2 A p p e n d i x 1 Templates of letters for use if found not of Standard Quality [Frozen and expired goods ]

Frozen Drugs-ordered to return to the Suppliers-reg(New drug policy 2009)

Frozen Drugs-ordered to return to the Suppliers- for issue of gate pass after verification reg(New drug policy 2009) Stop instruction-reg(New drug policy

2009) Appendix II Material handling in drug stores

31

3 PROCUREMENT ndash Government Order Relating to

the Management of Stores

(Reproduced for reference material on basic

procedure in decentralized system followed by

Health facilities in 1977)

54

F L O W C H A R T S f o r a BI R D S E Y E V I E W o f

P R O C U R E M E N T

5 5

ACQUISITION OF STORES 6 1

PLACING OF ORDERS 6 2

RECEIPT OF STORES 6 2

CUSTODY 6 3

ISSUE OF STORES Maintenance of Stock Books

6 3

PROCEDURE OF INDENTING FOR WARD amp OTHER SECTIONS OF THE INSTITUTION

6 4

HOW OFTEN TO INDENT 6 5

EMERGENT INDENT 6 5

HOW TO INDENT 6 5

KEEPING OF RECORDS IN WARDS A N D S E C T I O N S

6 6

ACCOUNTABILITY OF DRUGS BROUGHT BY THE PATIENT OR RECEIVED IN DON A T I O N BY T H E WARDSECTION _IN - CHARGE

6 7

RESPONSIBILITY OF STORES AT VARIOUS LEVELS

6 7

DISTRIBUTION OF MEDICINES FROM OUTDOOR DEPARTMENT

6 7

LOSS BREAKAGE DAMAGE ETC 6 8

PROCEDURE FOR WRITING OFF STORES 6 9

DISPOSAL OF WRITTEN OFF ARTICLES 7 1

FORMATS TO BE USED 7 3 - 81

32

STORAGE AND STOCK MANAGEMENT The expiry periods of pharmaceutical products have meaning only if the products are stored under proper conditions otherwise products are likely to lose their potency before the actual date of expiry

A pharmacist is a vital link in the distribution chain for pharmaceutical products The medicinal products remain for a long period during the distribution cycle at the wholesaler and at retail pharmacies It is therefore very important to maintain proper storage conditions in these units

Every community pharmacy however large or s mall needs to store and manage its medicine stocks effectively There must be systems to ensure

middot bullbull Secure storage middot bullbull Clean and correct environmental conditions during storage middot bullbull Accurate and effective record keeping middot bullbull Effective stock rotation and expiry monitoring middot bullbull Effective fire and theft prevention middot bullbull Effective rodent pest control

For easier un derstanding this module has been divided into the following sections

1 Quarantine and checking of stocks 11 Quarantine area 12 Checks to be carried out on new stocks

2 S t o r a g e 21 Need for proper storage 22 Different patterns of storage 23 Different means of storage 24 Temperatureclimatic conditions 25 Special storage of supplies 26 Storage and stability of medicines

3 Stock Control and Expiry Monitoring 31 Stock control 3 2 S t o c k r o t a t i o n a n d e x p i r y m o n i t o r i n g

4 Other aspects of s t o r a g e 41 Design of a storage area 42 Cleaning and maintenance 43 Product recalls 44 Returned goods

33

1 QUARANTINE AND CHECKING OF STOCKS

11 Quarantine Area D r u g S t o r e pharmacies receive stoc k s f r o m su pplie r s a c c or d ing to pur c h a se o r d e r s T he stock that is received must be visually checked for quality and quantity The stocks must be kept in a separate area until the checking is done to avoid intermixing with existing stock This necessitates the presence of a separate area within the pharmacy w h e r e i n t h e storage and other checking of stocks can be performed This area is called the QUARANTINE AREA This area should be marked and identified adequately to distinguish it from other areas

The area may be marked using different means 1 ) A s m a l l board saying Quarantine on a separate table used exclusively if it is in the middle 2) A board on the wall if the table on which the quarantine stock is placed is against the wall

middot Stock received from wholesalers should be immediately transferred t o t h e Quarantine Area

middot In the Quarantine area the stock may be stored on racks shelves or in cupboards to prevent ingress of moisture dirt and other contaminants

middot Regular stocks from the pharmacy should not be left kept in the quarantine area Special care has to be taken in case of refrigerated medicines supplied by the suppliers so tha t the y do not remain in the quarantine area for long periods of time They should be immediately checked on receipt and transferred to areas for refrigerated storage s o a s to maintain the cold chain bull

Advantages of having a separate Quarantine Area middot Avoids cross mixing of newly arrived stock from existing stock till it is checked middot Lays stress on checking the quality of the stock received middot S to ck checking ensures t hat defective andor expired goods do not enter the storage areas

34

bullbull

bullbull

12 Checks to be carried out on new stock

Unpacking and checking stock

Supplies received should be unpacked and checked in the quarantine area Staff doing the checks should be adequatel y trained in what they have to check when stock arrives

Checking should be seen not simply as counting the units received but as a part of the quality assurance system bullThis should include middot Visually inspecting the packaging middot Checking the integrity of containers middot V erifying the completeness and leg ibility of la b e ls ( a ppr o ve d dr u g name strength any special storage instructions and expiry date)

bull

The expiry dat e should be checked to ensure that there is adequate shelf life remaining

Supplies should be individually checked using a checklist 35

Checklists

36

The wholesaler supplying the product should be notified immediately in case of any discrepancies ( and the details should be recorded in a register) and sent in a written format to the supplier It should include middot Missing boxes or cartons middot O p en tampered boxes or cartons middot Missing supplies middot Differences in the actual quantity and the quantity shown on the packing middot Additional medicines that had not been ordered but have been supplied middot D a m a g e d b r o k e n o r p oor quality medicines middot Any other discrepancies

The purchase invoices are an important aspect to be considered The invoiced documents should be signed and filed for reference as per the Drugs and Cosmetics Act and retained for at least 3years

If the wholesaler supplies medicines as an emergency without a bill or against a delivery challan

middot The supplies should be checked for integrity and inspected for damage middot The details of supplies received should be recorded middot The supplier should be asked t o send the bill as early as possible middot When the bill is received it should be checked against the details recorded and anomalies if any should be reported to the supplier

To keep a track of the received stock maintaining a S t o c k R e c o r d C a r d c a n b e very useful The entries in the stock record card can be made while checking the stock received STOCK BIN in the stores should have Stock record card

Maintaining a stock card for every product may not be very practical for a retail pharmacy however it could be maintained for costly medicines Nowadays it is much more practical and easier to maintain records using computers

The pharmacist should ensure that medicines manufacturedmarketed by a company are received only through an authorized distribution network of that company This is important to prevent spurious and counterfeit drugs from entering the pharmacy

37

2 STORAGE 21 The need for proper storage The storage of medicines and other products is an important requirement of Good Pharmacy Pr actice Appropriate storage of medicines is essential -

middot bullTo ensure that the potency is maintained middot bullTo prevent deteriorationspoilagedegradation middot bullTo ensuremaintain physical integrity

To ascertain that the quality and safety is maintained throughout their shelf life Storage requirements need to be considered on 2 aspects

a) Integrity of medicines Medicines should be stored in such a way so as to maintain their integrity and potency middot Maintain the right temperature required middot Protect from excessive humidity middot Keep medicines away from direct sunlight middot Protect from pests and rodents

b) Physical location middot Should be easy to locate middot Accessible middot Orderlysystematically placed

2 2 D i f f e r e n t p a t t e r n s o f s t o r a g e The pharmacist could follow any of the different patterns of storage The pattern of stora ge should be selected in such a way that it facilitates speedy and efficient dispensing of medicines

The pattern of storage could vary with each pharmacy experience usual practiceroutine of staff and the person-in charge and also depending on space av ailable turnover etc (i) The medicines could be stored c o m p a n y w i s e ie the medicines manufactured by one company should be grouped together and kept in one place Within each company shelfshelves the medicines may be placed in alphabetical order for easy and quick placement and removal Also bottles tubes boxes etc may be segregated within that shelf

38

(ii) The medicines may also be stored in a lphabe t ic al o r de r ie they are placed in order from left to right based on their name The first letter of the name is used to g r o u p t h e m e d i c i n e s t o g e t h e r a n d k e e p t h e m i n o n e l o c a t i o n I n s o m e p h a r m a c i e s a l l t h e strip packing are placed in drawers or boxes in alphabetical order each box or drawer containing strips of one particular alphabet This system ensures that the strips always remain e n c l o s e d i n t h e b o x e s d r a w e r s a n d a r e n o t e x p o s e d t o d u s t T h e d i s a d v a n t a g e i s that it might lead to mix -u p o f strips in the same drawer and it may cause a problem incase of similar looking strips in which case a wrong medicine may be dispensed Secondly cut strips lying around in the drawer may lose their identity if the batch n u m b e r andor expiry date is not seen on the cut portion of the strip

39

(iii) The medicines may be stored according to their therapeutic class ( e g a n t i b i o t i c s anti asthmatics or anti hypertensives) ie the medicines are kept together based on their pharmacological or therapeutic action

(iv) The medicines may be stockedsegregated according to dosage forms eg l i q u i d s (bottles) solid oral dosage forms eye drops rotacaps ointments etc all stored on separate shelves

Always Remember I Storage of prescription medicines should preferably be separate from OTC medicines OTC medicines especially those that a r e a d v e r t i s e d m a y b e d i s p l a y e d f o r c l i e n t s t o select or to ask questions about [OTC-O v e r t h e c o u n t e r ] II Storage according to temperatures is a must no matter which pattern of storage is followed Also within a particular storage area segregated storage may be maintained In a refrigerator for example medicines may be stored in trays racks and the freezer according to the temperature required

40

Whatever pattern of storage is selected all the personnel should ensure that middot The stocks are stored in an orderly manner middot The medicines are kept back in the same place from where they were removed middot All medicines are arranged neatly once in a while

middot The personnel should be careful while storing the medicines middot They should not throw the medicines haphazardly 23 Different means of storage

middot Within each temperature and security zone medicines must be stored so that they are easily accessible and protected against damage

middot Basic means of storage include shelves racks and drawers middot To prevent dust from entering the shelvesracks it is ideal to have glass

shutterssliding glass doors This can however be disadvantageous because accessibilityspeed is hampered in removing a product from the shelf because the glassshuttersliding glass has to be

41

opened m o v e d e v e r y t i m e a p r o d u c t h a s t o b e p i c k e d u p U s e o f a i r c o n d i t i o n e r s f o r t h e p h arm acy with a closed door at the e n t r a n c e o r a n a i r c u r t a i n c a n r e d u c e t h e d u s t problem In such cases the shelvesracks may be left o p e n

bull

middot Direct storage of cartons on the floor should be avoided because besides being an unhealthy practice the contents may also be damaged by moisture bull

middot Store medicines preferably in shelves with glass shutters for visibility middot Closed shelves further prevent dust from going in especially in India where most

pharmacies are located along busy roads middot Some medicines have to be refrigerated or stored in a cool or cold place Having a

refrigerator or two (as per the need of the pharmacy) is essential to store suc h medicines at temperatures mentioned on the label bull

42

Refrigeration middot All cold chain equipment should meet required standards middot Improvement in refrigeration technology has provided frost -free refrigerators

Pharmacists should opt for frost-free refrigerators as they are easy to maintain and protect printed packaging materials Conventional refrigerators may cause water falling from trays below the freezer on medicines stored in the refrigerator thus causing soggy labels

middot bull Frost-free refrigerators also provide separate and large compartments for the freezer portion (required for storing medicines needing sub-z e r o t e m p e r a t u r e ) and the main storage area with separate doors so that opening one door does not disturb the storage temperature in the other compartment

Care should be taken to keep the refrigerator on 24 hours a day It should not be switched off after working hours It is advisable to have an inverter connected to the refrigerator so that the refrigerator re mains working even when there is a power outage

middot The refrigerator door should be closed tightly middot The refrigerator door should not be left open for too long middot Space should be left between medicines stored in a refrigerator to allow air to

circulate middot The ref rigerator should be placed about an arms length away from the wall

This will increase air circulation thus not affecting the cooling within the refrigerator

middot Vaccines should not be stored on refrigerator door shelves as they are exposed to warmer temperatures each time the door is opened Vaccines should always be stored on the middle shelves of the refrigerator

middot Refrigerated medicines should not be left out of the refrigerator for more than a few minutes

43

middot Consumable products like juices energy drinks e t c s h o u l d n o t b e s t o r e d a l o n g with medicines in refrigerators If required they may be kept in a separate refrigerator

middot An adequate number of refrigerators should be planned to store the entire stocks requiring refrigerated storage

middot Adequate procedures should be followed for defrosting cleaning and maintenance of refrigerators

middot Icefreeze packs should be kept in the freezer compartment so that they can be used for transporting cold temperature medicines The packs can be given to clients along with the medicines requiring cold temperature storage so that the temperature is maintained till the client reaches home and can then put the medicines in a refrigerator) Freezer packs can also be used to keep medicines temporarily in case there is a power outage or refrigerator breakdown

Activity

Prepare a SOP (Standard operating procedure chart) for cleaning a refrigerator Discuss it with your staff finalize its maintenance once a month through AMC -A n n u a l Maintenance contract CMC - Comprehensive maintenance contract and put it up on the pharmacy refrigerator Put the Purchase Order details name of manufacturer Phone of Service Engineer and a register to login the Machine service and down timeService reports may be maintained properly

Refrigerator monitoring and maintenance

middot bullIt is important to carry out routine monitoring and maintenance of the refrigerators and to organize an effective repair system

middot bullThe temperature in the refrigerator must be monitored and recorded routinely at least once a day

middot Any breakdown must be reco rded including the period during which the medicines were exposed to uncontrolled temperatures Medicines may then be kept or discarded depending on the problem guidelines or the manufacturers advice

middot Cold chain monitor cards and devices in or on packages that change color or otherwise alert staff to potential damage assist in monitoring (These are likely to be introduced in India soon)

middot It is essential to have a contingency plan in place before a refrigerator breaks down An arrangement can be made to move the contents to a private refrigerator elsewhere in the community or to obtain a regular supply of ice packs until the defect is rectified

Put filled water bottles in the bottom half of the refrigerator door in order to provide cooling in the refri g e r a t o r w h e n t h e r e i s a p o w e r o u t a g e T h i s m i g h t t a k e c a r e o f t h e temperature when there is no current for a couple of hours If the power outage is expected to last for several hours special arrangements such as an inverter UPS have to be made to keep the refrigerator constantly running in the absence of electricity middot Defrost the refrigerator in case of excessive ice formation and preferably at regular

intervals Keep a record of the same

44

2 4 T e m p e r a t u r e c l i m a t i c c o n d i t i o n s

i) Temperature control middot The medicines in a pharmacy need to be stored at appropriate temperatures to

maintain their stability middot An air-conditioned environment where temperature can be controlled is

recommended for pharmacies Air conditioning offers the option of setting the t e m p e rature as per requirements

middot bullIt is ideal to have an air conditioner to maintain the temperature below 25 C as most medicines require storage below this temperature Secondly this temperature is pleasing to both the staff and the visiting customers too

middot In the absence of an air conditioner circulating fans may be used middot This need is felt even more in certain parts of India where temperatures soar above 45

C and some areas where it falls to sub zero temperatures In such cases temperature maintenance is essential to prevent deterioration of medicines due to unnecessary exposure to drastic temperature fluctuations

middot This need is felt even more in certain parts of India where temperatures soar above 45 C and some areas where it falls to sub zero temperat u r e s I n s u c h c a s e s temperature maintenance is essential to prevent deterioration of medicines due to unnecessary exposure to drastic temperature fluctuations

i i ) Humidity or moisture control Moisture or humidity can adversely affect the stability of me dicines such as tablets capsules powders

45

Gelatin capsules become soft and swell on absorption of moisture The drug content of tablets may undergo surface hydrolysis The presence of moisture may encourage the growth of microbes It is therefore essential to control humidity

To reduce the effect of humidity the following suggestions may be followed -middot Open the windows to allow air circulation Use a fan to circulate fresh (outside) air middot In humid climate a dehumidifier is useful for preventing mo i s t u r e d a m a g e ( i n t h e absence of an air conditioner) middot For bulk containers of tabletscapsules do not keep the container open for a long time and replace the lid or closure immediately after taking out the required number of medicines for dispensing middot Do not allow the medicines to touch the floor or the walls The walls may be damp and may cause moisture absorption damaging the product

middot Calibrated thermometers and manometers can be used to detect temperature and humidity in the pharmacy

middot Periodici t y of checking the temperature should be fixed middot The climatic conditions should be recorded and documented middot Temperature charts should be available for ready reference

Documentation is one of the core activities for achieving and maintaining quality It is one of the most essential components of validation Temperatures in various areas

46

including refrigerators should be recorded at a predetermined periodicity usually daily at the hottest time of the day and such documents should be preserved i i i ) Storage conditions A number of storage conditions are mentioned on the labels of medicinal products These conditions have to be properly interpreted and appropriately complied with

According to the Drugs and Cosmetics Rules 1945

1 The term cool place means a place having a temperature between 10 C and 25 C

2 The term cold place means a place having a temperature not exceeding 8 C In case of storage conditions for specific products please refer to Schedule P The Drugs and Cosmetic Rules 1 9 4 5

The Indian Pharmacopoeia specifies the following storage conditions -

Wherever the condition for storage is not specified medicines may be stored under normal temperature In a country like India however where normal temperatures soar to h i gh temperatures it is recommended that medicines be stored in a cool place

Activity Prepare a list of the storage requirements mentioned on the label of about 20 products in your pharmacy and check if the temperature is maintained

47

25 Special Storage o f s u p p l i e s If the product has no special instructions normal storage conditions apply This means storage in dry clean w e l l -ventilated premises at temperatures of +15 C to +25 C or depending on the climate up to +30 C (WHO1990) Storage instructions are product specific Different brands of the same generic drug may have different storage requirements as they may have different packaging or formulations It is essential to follow the product manufacturers storage instructions to the maximum extent possible Less stable medicines must be stored in specific conditions to maintain their quality or potency

The following products require special storage facilities

middot Products that must be kept frozen (usually vaccines and sera) middot Products sensitive to h eat an d r e q uir in g r e f r ig e r a tio n ( +2 C to +8 C) middot Products that have reduced shelf life at uncontrolled room temperature and need

mechanical ventilation or air conditioning middot Flammable products that require separate fireproof premises middot Products prone to theft o r m i s u s e

Products needing storage in a controlled environment -

The usable shelf life of the following products may be reduced if stored at uncontrolled humidity or at room temperature in hot climates -

middot Some injectables (eg adrenaline) Most injectable preparations are less stable than solid oral forms (tablets and capsules) Injectable preparations in solution are particularly unstable Many injections must be protected from light as well as heat

middot Intravenous fluids (particularly if packed in p lastic containers) middot Some suppositories pessaries creams and ointments These products may melt at

temperatures greater than 30 C Once this happens it is not advisable to use them because the active ingredient in the formula may get unevenly distributed

middot Products containing rubber latex cellulose or some plastics Condoms most sterile disposable medical devices and surgical products such as syringes needles and catheters require protection from excessive humidity and strong light and heat Any o f these conditions may make products brittle stained amp unusable Sterility cannot be assumed if packaging is damaged

In hot climates these products should be stored in the coolest place possible preferably with air conditioning or air circulation fans

48

Products needing freezing or refrigeration-middot Vaccines blood products and many other medicines lose potency if kept even for a

brief period at temperatures outside the recommended range For these products the cold chain must be maintained at every stage of the distribution system

middot Freezing is as damaging as high temperatures for some products including injectable contraceptives ergometrine insulin adrenaline and the DPT DT TT and Hepatitis B vaccines Such products therefore sho uld not be allowed to freeze (not be kept in the freezer compartment)

middot Short periods at room temperature (during transportation or local distribution for instance) may be acceptable for many products (such as ergometrine a n d i n s u l i n ) e v e n t h o u g h s u c h e x posure can to some extent reduce shelf life Other items such as vaccines should always be transported in cold boxes

Storage of insulin injections-

middot Insulin should always be stored in a refrigerator at the recommended temperature of 2 -8 C

middot Insulin should not be kept in the freezer compartment of the refrigerator middot Insulin should ideally be stored horizontally middot It should not be exposed to sunlight or excessive heat middot Insulin suspensions should not be used if the suspension cannot be properly

resuspended due to cake or clump formationbull

Controlled drugs -Narcotics (for example Pethidine injection morphine preparations) and other specified drugs that may be abused are governed by special legislation and regulations The following security measures are suggested in the pharmacy -middot A safe or reinforced double locked cabinet fitted with a light (preferably with a red

bulb) that comes on when the door is opened

49

middot A special register recording details of each receipt or issue with 2 signatures physi cal counting of medicines after each entry and signatures at handover takeover

middot Independent audit (by supervisors and drug inspectors)

Products prone to theft abuse or misuse -

Some medicinesproducts are particularly prone to theft abuse or misuse These include expensive medicines (eg insulin) certain antibiotics and products prone to abuse or misuse like psychotropics etc

Such medicinesproducts should be stored adequately They require stricter record keeping and more frequent stock taki ng than others Periodic audits should be carried out to check for consumption against actual recorded use (registers prescription records stock records etc) to expose any theft or misuse bull26 Storage and stability of medicines Medicines are not stab le indefinitely They are stable for a specific period of time sometimes for a brief period Poor storage conditions accelerate the drug degradation (decomposition) Temperature light and moisture are the most important contributing factors for drug instability It is important to identify and be aware of the potential for instability There is a need to comply with storage requirements to ensure quality medicines for patients It is also important to offer advice to patients too about appropriate storage o f medicines at home The dispensing label should state the storage condition required and be backed up by a verbal reminder especially where special storage is required bull

50

In case stability and storage problems are seen with formulations they should be reported immediately to the representative of the manufacturer and taken out of circulation till the stability problems have been resolved

The pharmacist can easily detect stability problems when products show change in appearance color odor settling of the product contents breaking of emulsions melting of creams oozing of contents from the containers and any such physical changes

3 STOCK CONTROL AND EXPIRY MONITORING 3 1 S t o c k C o n t r o l For economic reasons pharmacists do not like to have stock on their shelves for long periods of time The aim should always be to keep stock at a level that will just meet demand Normally most manufactured medicines have a long shelf life Even then it is essential that there is efficient stock rot ation so that the older stock is used first It is also a good practice to check the expiry date as an integral part of the dispensing process When short shelf life products are involved stock levels may have to be modified to prevent medicines regularl y expiring on the shelves

32 Stock rotation and expiry monitoring In order to avoid accumulation of expired and obsolete stock medicines should be stored and issued according to the following guidelines -middot The stock control system must record the ex p i r y d a t e a n d t h e d a t e o f r e c e i p t middot Stock must be stored so that earliest expiring batches are picked and issued first middot The First In First Out (FIFO) system - In this system the stock which is received

first is sold first This system however may not be useful for pharmacies because most of the stocks carry an expiry date For pharmacies the FEFO system is more practical

51

middot The First Expiry First Out (FEFO) system - In this system the stock having an earlier expiry is sold first The stock with longer shelf life should be placed farthest to the back (or at the bottom in case o f sta c k e d b oxe s) T h is is pa r tic u la r ly impor ta n t with products that have short shelf lives such as vaccines some vitamins antibiotics etc and reduces losses due to expiry

middot E x p i r y dates should be noted on the stock record upon receipt Stock nearing expiry should not be accepted unless it can be used before expiry

Computerization and expiry monitoring In the pharmacy computerization facilitates both checking stocks and expiry mo nitoring and helps-bullbullKeeping a check on products nearing expiry bullbullKeeping a check on non- moving and slow moving products bullbullTo facilitate the removal of medicines nearing expiry from shelves in time to send them back to the wholesaler or supplier

Periodic checking for expiry The expiry date for medicinal products is a critical aspect in pharmaceutical dispensing and due importance should be given to it Periodic checking for expiry of medicines will ensure that the patient will never receive products that have crossed their expiry date During periodical checking of expiry the personnel involved should remove medicines that are nearing expiry bullbullIn -house threshold periods should be set and followed for retrieval of such medicines from the shelves bullbullSuch medicines should be stored separately These should either be dispensed immediately (thus ensuring that they are used before the expiry date) o r t h e y s h o u l d b e returned to the suppliers bullbullA separate area should be designated (cupboard or shelf)marked[FROZEN ZONE] which is adequately marked EXPIRED GOODS- NOT FOR SALE to store all expired stocks FROZEN ZONE

52

Remember Expired medicines are a NATIONAL WASTE So stock only what you can sell Avoid expiries save precious medicines for the nation

Treatment and disposing of expired medicines bullbullProcedures need to be in place for the treatment of expired medicines bullbullThe expired medicines need to be collected and be sent back to the supplier or company for appropriate disposal bullbullRecords must be maintained for expired medicines and how they are disposed off bullbullIn case of medicines that are not returnable to suppliers procedures for disposal need to be followed by the pharmacy in conjunction with the FDA The following procedure can be followed if medicines cannot be returned to suppliers ( T h e b a s i c p h i l o s o p h y of appropriate disposal is to prevent their re- circulation and use) bullbullC u t t h e c o n t ainer in such a manner that the label is also cut In case of tablets and c a p s u l e s d e s t r o y them by disposing them in a bucket of water bullbullUse landfill procedures (deep burial into the ground as per stipulations of Medical Waste Disposal Act prevalent in the respective state) bullbullPour the liquids into the sink and wash away with sufficient quantity of water bullbullKeep a record of such disposal with full details of medicines destroyed Although these measures are usually adopted care has to be taken with such tr e a t m e n t a s studies have shown that flushing of medicines has resulted in tracessmall quantities of medicines being found in waterways and groundwater having potential health and environmental effects

4 O T H E R A S P E C T S 41 Design of storage areas The following important factors need to be considered in design of storage areas -middot The retail outlets in hot areas in summers should be air-conditioned Similarly in

a r e a s o f e x t r e m e c o l d t h e p r e m i s e s w o u l d r e q u i r e w a r m i n g e s p e c i a l l y i n w i n t e r s t o maintain cool temperatures The placement of air -conditioners and heating devices should be such that medicines are not directly exposed to the cold or heat

middot Due consideration should be given to storage requirements of formulations while designing shelves and cupboards in retail outlets Sufficient shelf height should be provided so that all liquid products can be stored vertically As far as possible the shelves should be covered with glass panels to protect medicines from dust and p r e v e n t r a p i d f l u c t u a t i o n s i n temperature

middot Medicines should be stored according to the storage instructions on the labels bullIt is ideal to have a door at the pharmacy entrance to prevent dust from coming in as well as reduceprevent cooled air from going out This may not however be considered feasiblepracticable by many pharmacy owners for fear that clients may not enter the pharmacy because the door may act as a barrier An air curtain is a good alternative to a door

middot There should be minimal direct sunlight falling on the products Particular consideration should be given to premises directly facing the sun

middot bullThe arrangement of lighting in the interior of the premises should also be in a manner that the lights are not focused on the products It has been shown that light causes not only chemical damage but also can catalyze physical changes like moisture uptak e by the products Care should be taken to ensure that only diffused light falls on them

53

middot As far as possible provision should be made for a temperature and humidity indicator device in a pharmacy These devices are now easily available

middot Stability studies o f m e d i c i n e s p a c k e d i n b l i s t e r s h a v e r e v e a l e d t h a t i f t h e s e a r e exposed to light they tend to absorb moisture It is therefore necessary to store them in suitable cartons so that the blisters are not exposed to light Pharmacists should do this even if the manufacturer has not provided cartons

middot Light and temperature sensitive products should not be stored on counters where the light is intense or direct and there is no protection from temperature and humidity

42 Cleaning and maintenance i) Cleaning of storage areas

The storage areas of the pharmacy should be cleaned periodically and cleanliness should be maintained at all times The Standard Operating Procedure for cleaning should be designed and followed accordingly Schedules for cleanups should be laid down and adequate cleaning equipment should be made available

Tips for maintaining cleanliness middot Provide clean pieces of cloth for wiping at various locations in the pharmacy

Replace with clean cloth at regular intervals middot Keep separate pieces of cloth for floors shelves and medicines middot Use a disinfectant andor soap solution to clean floors middot Ensure removal of dust and prevent accumulation of dirt middot Ensure removal of cobwebs middot Use a vacuum cleaner for cleaning areas not easily reachable middot T a k e c a r e t h at breakages are handled and cleared effectively middot Observe the factors leading to waste generation in the pharmacy and take appropriate

measures to tackle the problem middot Record all cleaning procedures performed and maintain all the documents required

For ex a m p l e -bullbullThe floor of the pharmacy may be swept with a broom and swabbed with soap water every morning bullbullThe floor may be swabbed with a disinfectant every week bullbullThe entire premises including shelves and cupboards may be cleaned with a cloth (to remove dust and to check for medicines approaching expiry date or expired medicines) every three months bullbullAll the steps followed should be r e c o r d e d

The floor shelves drawers have to be cleaned and a check should be kept on dust cobwebs spillages due to breakage etc It is therefore essential to have SOPs for cleaning laying down cleaning frequencies allotting responsibilities and maintaining a daily record in the logbook to document all these activities

54

While cleaning dust settled on dosage forms like bottles tubes etc should be removed Before dispensing the products should also be wiped to remove any dust settled during storage

For refrigerators bullbullDefrosting and cleaning should be done at regular intervals bullbullSwitch off the refrigerator while cleaning bullbullCleaning should be done quickly and stocks put back immediately

i i ) Pest control Pests are a serious problem in India where insects reptiles and rodents (eg cockroaches l i z a r d s r a t s s i l v e r f i s h (Deemak - in Hindi ) etc) may find access to the pharmacy storage areas Insects like ants and borer ants may often attack wood in the pharmacy causing d am ag e to shelves cupboardsPest c ontr o l in a p h a r m a c y c a n b e a d i f f i c u l t t a s k b u t t o avoid possible contamination and physical damage to stock it is necessary to keep pests out of the pharmacy premisesPest control measures should be implemented with proper p r e c a u t i o n s t a k i n g u t m o s t c a r e t o a v o i d contamination of medicines

55

Th e following pest control measures c a n be ta ke n f r om tim e to tim e -bullbullRat bait and traps can be placed at various locations bullbullInsecticutors can be used on a permanent basis bullbullInsecticidal sprays and repellants can be used from time to time

i i i ) Fire precautions

Combustible trash such as cartons boxes and other packing waste must not be allowed to accumulate in the store Waste should be deposited in appropriate waste bins and be d i s p o s e d o f f o n a d a i l y b a s i s

F i re detection and fire fighting equipment must be maintained and regularly inspected The pharmacy personnel should receive adequate training in fire fighting techniques and emergency actionFire prevention measures should include a prominently displayed ldquoNoSmokingrdquo sign careful handling and disposal of combustible waste materials and checking of electrical connections at regular intervals

iv) Security middot Doors shutters of the pharmacy should be strong and be fitted with secure locks middot Counters should be designed so that unauthorized personnelclients do not have

access to areas where prescription medicines are stored Access to such areas should be restricted to the pharmacy staff

middot All the pharmacy staff handling supplies should be accountable for their ac t i o n s

56

middot bullSpecial care must be taken in case of Schedule X and manufactured drugs (under NDPS Act) Such medicines should be kept under lock and key and the key should be kept with the Chief Pharmacist or i n h i s a b s e n c e t h e s e n i o r p h a r m a c i s t

v) Breakagespillage and damaged product Products that have been damagedspoiled during storage and handling spillages and broken glassware should be disposed off according to procedures laid down by the pharmacy Broken and damaged products s h o u l d b e p l a c e d i n a segregated area to be returned to the supplier

vi) Inspection Senior staff should inspect all pharmacy areas regularly The shelves and drawers should b e c h e c k e d d a i l y f o r signs of pests and dust Ceiling and walls should be checked for dirt and cobwebs Stock should be checked on a regular basis for deterioration due to climatic conditions

43 Product recalls Products found to be defective should be quickly recalled (withdrawn from the market) The instructions are generally issued either by the manufacturer or the regulatory agency The level of recall is determined by both the degree of risk and the extent of distribution of the product and in India is mainly directed at the distribution chain

On receiving the details of the defective substandard spurious batchbatches of a medicine to be recalled from the manufacturer or the stockist or the FDA the pharmacy should immediately check if the particular b a t c h i s i n s t o c k a n d i f s o s u s p e n d i t s s a l e immediately

Similarly if the regulatory authority in the country bans a particular medicine or FDC the pharmacy should immediately check and remove all the different brands of that particular medicine under consideration

The details of medicines and their batches to be recalled should be available in the q u a r a n t i n e a r e a w h e r e stocks are received and checked This is to ensure that such medicines do not come into the pharmacy

middot The pharmacy should develop SOPs for recall of medicines middot The pharmacy staff should be immediately informed about such medicines and

the details should be displayed in writing in a prominent place in the pharmacy middot Rapid action helps avoid unnecessary exposure to such medicines once the

problem has been d e t e c t e d middot The progress of the recall procedure in the pharmacy should be monitored every

few days to ensure complete compliance middot All stocks of the recalled products should be stored separately from the saleable

stock These can be stored in the expiry cupboard segregated from the expired goods and be appropriately labeled ldquoRecal l e d G o o d s - Not for Salerdquo

The supplier should be notified and asked to replace defective products middot All the details of the procedures followed should be duly recorded in a Recall

Register maintained specially for the purpose The register should include d etails such as -middot Date of the recall middot Nam e of the product

57

bullbull

middot Details of the product (name of manufacturer batch number expiry date) middot Nu m b er of units purchased sold a n d sto c k in ha nd middot Reason for recall middot Nam e of the supplier to whom produc ts w e r e returned along with the date and quantity middot Name and signature of the designated personnel carrying out the recall procedure and recording details middot Name and signature of the chief pharmacist verifying the recall procedures and recording details 4 4 Returned medicines

Medicines may be returned to the pharmacy by clients due to the following reasons -bull

bullbull Unused medicines bullbull Course not completed bullbull Therapy changed by doctor bullbull Side effects experienced by patient bull

bullbull DamagedDefective medicines bullbull Missing or defaced label bullbull Missing tablets in a stripblister bullbull Leakage in bottles bullbull Leakage in strips bull

bullbull Expired medicines

Appropriate SOPs should be framed and followed for their acceptancerefusal and disposal middot bull For unused medicines returned by clients the p harmacy personnel should verify

that these were purchased from their pharmacy They should then be checked for integrity of the packing the dosage form and the expiry date and verified with the client whether they were stored in appropriate conditions This again is at the discretion of each pharmacy

middot The damageddefective medicines returned to the pharmacy should be taken back and stored separately Existing stock of the same product should be checked for similar defects

middot Expired medicines should be accepted from clients at the discretion of the pharmacist and be immediately shifted to the expired goods cupboard These can be stored segregated from the pharmacys own expired goods and be appropriately labelled ldquoExpired Goods returned by clients- Not For Salerdquo

It is advisable not to accept returned medicines requiring cold chain storage (refrigeration) because it cannot be ensured that the cold chain was maintained when the medicines were in the hands of the patientclient middot Appropriate adjustments in t he stocks should be made for medicines

returnedexchanged to update the inventory middot The medicines should then be returned to the respective shelves middot A lsquoReturned Goodsrsquo register needs to be maintained to record all details of returned

medicines

R egister should include such details as-

58

middot N a m e o f t h e p a t i e n t middot Nam e of the product and quantity r e tu r n e d middot Product details such as the batch number and expiry date middot Condition in which received middot Reason for returning products middot Compensatory measures taken wi t h r e s p e c t t o c l i e n t middot Action taken with respect to product middot Name and signature of the personnel accepting the returned medicines and recording details middot Name and signature of the chief pharmacist verifying the recorded details

What the pharmacist would have learnt from this module The storage of medicines is a critical factor in the distribution cycle bullbull Stocks received by the pharmacy should be quarantined in a separate area and necessary checks s h o u ld be performed to ascertain the qua lity a nd quantity of stocks received bullbull Whatever pattern and means of storage used the products should be stored so as to maintain their potency and integrity bullbull Storage conditions should be monitored and maintained on a regular basis bullbull Optimum stock levels should be maintained and regularly monitored for expiry bullbull The design of storage areas should facilitate appropriate storage of medicines bullbull Cleanliness should be maintained in the pharmacy bullbull Adequate measures should be taken in case of returned medicines and recalled products

Optimum storage of medicines is mandatory whether at the distribution stage at the pharmacy or ultimately within the homes of patients The pharmacist has an important r o l e t o p l a y i n t h e s t o r a g e o f m e d i c i n e s i n m a i n t a i n i n g d r u g p o t ency and efficacy and thus facilitating optimum therapeutic benefits Good Pharmacy Practice - IPA -CDSCO - WHO Appendix I Quality Assurance Templates of letters for use if found not of Standard Quality [Frozen and expired goods ]

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated To Name of the Supplier with address

Sub Not of Standard Quality GoMP-Supply of Drugs and medicines-(Codename) Return of Stocks to the Suppliers-reg(New drug policy 2009) Previous letterinvoice ref Sl No Drug Code Drug name

Manufacturing date Expiry date

Supplier address

B a t c h n o

The above items of PO nodated was drawn by the Drug Inspector (Place) on (______________date) as a statutory sampling and declared ldquoNot of Standard

59

Qualityrdquo on -(______________date) by the Government Analyst for the following reasons

- ldquoThe product sample do not confirm to IP specification for (Drug codename with respect to the content of drugrdquo

- ldquoThe product has already been blacklisted by TNMSC on -(______________date) for the failure of (quantity) of batches of drug codenamerdquo

As per the clause of the te nde r d oc um e nt ldquo I f the sa mple s d o not c onf o r m to statutory standardsthe tenderer will be liable for relevant action under the existing laws and the entire stock in such batch should be taken back by the tenderer within a period of 30 days o f t h e r e c e i p t o f t h e l e t t e r f r o m t h e v e n u e

The stock shall be taken back at the expenses of the tendererthe Procurement Authority have the right to destroy such Not of Standard Quality if the tenderer does not take back the goods within the stipulated time

The Procuring Authority will arrange to destroy the Not of Standard Quality drugs within 90 days after the expiry of 30 days mentioned above without further notice and shall also collect demurrage charges calculated at the rate of 2 per week on the value of the drugs rejected till such destructionrdquo

Hence we regret to inform you that you will have to take back the stocks available of the abovesaid batch at your own cost from the drug stores where you have supplied the above batch

Kindly acknowledge the receipt of this reference at once

P r o c u r e m e n t A u t h o r i t y Seal and Stamp

Copy to Ref No dated

1 ) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated13082010

To

Sub Frozen Drugs-ordered to return to the Suppliers-reg(New drug policy 2009) Previous letterinvoice ref

The following products which were earlier frozen have now been ordered to return to suppliers directly with permission from the State drug Authority In this regard the suppliers have been instructed to take back their failed batch from the drug store of the stores Hence you are now instructed to return the following failed batches to the suppliers by obtaining proper authorization letter and acknowledgements from them

60

Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

Kindly acknowledge the receipt of this reference at once

Procurement Authority Seal and Stamp

Copy to

Ref No dated 2) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated14092010

To

Sub Frozen Drugs-ordered to return to the Suppliers- for issue of gate pass after verification reg(New drug policy 2009) Previous letterinvoice ref

The following products which were earlier frozen have now been released Hence they may be issued Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

Kindly acknowledge the receipt of this reference at once

Procurement Authority Seal and Stamp

Copy to

61

Ref No dated 3) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated

To

Sub Stop instruction-reg(New drug policy 2009) Previous letterinvoice ref

Until further instructions stop issue all the batches of the following item Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

You must intimate the available stock in the stores of the said batch Number to the Procurement Authority immediately Also retrieve quantity if already issued

Procurement Authority Seal and Stamp

Copy to

Ref No dated 4) HOD Procurement Office of

62

Appendix II Material handling in drug stores

Rack approx rates and dimensions

S No

Item Description UOM Approx Rate

1 MEDIUM DUTY RACK SIZE 2900 H X 3090 W X 800 D IN MM (AS PER SPECIFICATION)

Each 2499800

2 MEDIUM DUTY RACK ADD ON UNIT FOR SIZE OF SR NO2

Each 2243100

To locate a Box no 3 Rack no 14 in row3

SAMPLE OF RACK no Bin numbering -------------- S a y R K 1 4 R o w 3 B o x 1 6

SAMPLE LAYOUT of RACKS in a Drug Stores

63

Sample of another warehouse of distribution warehouse system

64

65

Slotted Angle racks with bin cards

66

Plastic Pallets

Plastic pallets ar e l i g h t w e i g h t l o w- c ost and exceed industry standards for strength and durability

NOTE A pallet has bottom deckboards (see sketch) A skid does not have bottom

67

deckboards

Battery Operated Stacker

Electric Stacker Ehh (Manual Push Type) - Manual drive - Lifting electrically with Battery 12 V 88 Ah - For loading and un-loading of trucks - Battery and loading device built - in - Battery charge gauge and charging current gauge Simple and Easy Operation - Lifting and Lowering electrically direct on steering arm - Pulling and pushing through steering arm - Electrically operated relief valve on hydraulic aggregate Safe Operation - Emergency Off Switch - Constant lowering speed - Protection through lowering brake valve - Overload protection through overload brake valve - Load chains covered preventing pinching threat - Electrically interlocking during loading process - Secured battery compartment opens upwardly - Stable buffering of the steering arm in upright position - In accordance with EWG Guidelines 89 240 - In accordance with VBG 12b Prevention of Accidents

Pallet Truck [ Top ]

68

----------------------------------------------------------------------------------------------------------------------------

For Transport Of All Goods On Pallets Safe and Easy Operation - through single hand operation Lifting moving

lowering with steering handle - neutral position of the hydraulic possible - overload pressure relief valve Long Service Life - robust co n s t r u c t i o n

- special hardened axles - hardened chromium plated ram - maintenance free Easy Maneuverability - through rubber steering rollers - nylon fork rollers

A h a n d t r o l l e y

69

Trolley with plastic bins for several items del ivery

70

Digital Weighing balances

Balances amp Scales EF Seriers Precision Electronic Balance

71

1

Ice lined Refrigerators

600 litres refrigrator

72

Walk in cooler

vacuum cleaner

73

Annexure C

STOCK REGISTER FOR DEAD STOCKS

SERIAL NO DATE OF RECEIPT

Article with description

No of pieces Cost Details of

Bill Signature No Disposed

Date of disposal

Manner of Disposal

with Authority

Value realised Signature

1 2 3 4 5 6 7 8 9 10 11 12

P r e p a r e d B y C h e c k e d b y A p p r o v e d b y

Date Designation Name of Institution

22

Annexure D

STOCK REGISTER FOR EXPENDABLE ITEMS Name of article

Date

From where

received with cost

Quantity Signature To whom issued Quantity Balance Signature

1 2 3 4 5 6 7 8

23

Annexure E

Receipt amp Issue Register for WARDSSECTIONS (one or more pages as per requiremnt for each medicine)

NAME OF MEDICINE RECEIPT ISSUE

DATE Quantity In Stock

Date of

Issue

Issued toMention Bed no amp

quantity (in bracket) (For

Outdoor cases give Regd No)

Balance Signature

24

Annexure -F

OUTDOOR FREE MEDICINE SLIP In Duplicate

Name of Patient Registered No Date

Sr no Name of Medicine Quantity

Seal amp sign of doctor

25

Annexure-G

TREATMENT CARD

WARD NO

NAME OF PATIENT BED NO DATE amp TIME OF ADMISSION DATE amp TIME OF DISCHARGE

DATE MEDICINES PRESCRIBED SIGNATURE

26

ANNEXURE -H

PROFORMA FOR BREAKAGE amp LOSS

NAME OF OFFICEINSTITUTION DATE PLACE

SRNO NAME amp

DESCRIPTION OF ARTICLE

COST DATE OF PURCHASE

REASON CAUSE OF BREAKAGE

RECOMMENDATION OF INVESTIGATING AUTHORITY

Signature

Orders of the Competent Authority

Signature

27

Annexure ndash I Loss- Procedure for Reporting

1 The exact nature of the defalcation 2 The full extent of loss 3 The actual period covered by the defalcation 4 The defects in the negle c t o f r u le s by w hic h the loss was rendered possible

and circumstances which facilitated the defalcation 5 The names of the officials held personally or technically directly or

indirectly and wholly or partially responsible for the irregularity c o m m i t t e d i n t h e c a s e

6 Whether the c a s e a s b e e n J u d i c i a l l y t r i e d i n a c o u r t o r n o t i f s o c o p i e s ( i n duplicate) of the Judgment may please be furnished Copy of police report may also be furnished

7 The remedial measures adopted as safeguards against the losses hereafter 8 The prospects of re covery of the loss and he action taken to effect

recovery together with the amount recovered 9 Head of Account to which the Loss is debitable may be informed

Signature of Head of Office with seal

NoteA copy of this report is to be sent to AGMPThis is as per M P Finance Code Vol I

28

STORAGE AND STOCK MANAGEMENT

29

Foreword

The New Drug Policy 2009 is being implemented in the State of Madhya Pradesh

In order to have a proper procedure for Storage maintenance and expiry management of the drugs it is necessary to follow Good Storage Practices with Standard Modules for pharmacistStore keepers

Proper guidelines on Storage Practices can lead to better Stores and inventory upkeep with medicines being properly stored in racks with proper cleanliness and hygiene

This is a step towards storage maintenance and expiry management at the various stores in the state Looking forward to see that the heads of all health facilities take benefit from this module

D ir e c t o r M e d i c a l S e r v i c e s

30

INDEX

Sr No P a r t i c u l a r s P a g e

1 S T O R A G E A N D S T O C K M A N A G E M E N T 4

1 Quarantine and checking of stocks 11 Quarantine area 12 Checks to be carried out on new stocks

2 S t o r a g e 21 Need for proper storage 22 Different patterns of storage 23 Different means of storage 24 Temperatureclimatic conditions 25 Special storage of supplies 26 Storage and stability of medicines

3 Stock Control and Expiry Monitoring 31 Stock control 32 Stock rotation and expi r y m o n i t o r i n g

4 Other aspects of storage 41 Design of a storage area 42 Cleaning and maintenance 43 Product recalls 44 Returned goods

2 A p p e n d i x 1 Templates of letters for use if found not of Standard Quality [Frozen and expired goods ]

Frozen Drugs-ordered to return to the Suppliers-reg(New drug policy 2009)

Frozen Drugs-ordered to return to the Suppliers- for issue of gate pass after verification reg(New drug policy 2009) Stop instruction-reg(New drug policy

2009) Appendix II Material handling in drug stores

31

3 PROCUREMENT ndash Government Order Relating to

the Management of Stores

(Reproduced for reference material on basic

procedure in decentralized system followed by

Health facilities in 1977)

54

F L O W C H A R T S f o r a BI R D S E Y E V I E W o f

P R O C U R E M E N T

5 5

ACQUISITION OF STORES 6 1

PLACING OF ORDERS 6 2

RECEIPT OF STORES 6 2

CUSTODY 6 3

ISSUE OF STORES Maintenance of Stock Books

6 3

PROCEDURE OF INDENTING FOR WARD amp OTHER SECTIONS OF THE INSTITUTION

6 4

HOW OFTEN TO INDENT 6 5

EMERGENT INDENT 6 5

HOW TO INDENT 6 5

KEEPING OF RECORDS IN WARDS A N D S E C T I O N S

6 6

ACCOUNTABILITY OF DRUGS BROUGHT BY THE PATIENT OR RECEIVED IN DON A T I O N BY T H E WARDSECTION _IN - CHARGE

6 7

RESPONSIBILITY OF STORES AT VARIOUS LEVELS

6 7

DISTRIBUTION OF MEDICINES FROM OUTDOOR DEPARTMENT

6 7

LOSS BREAKAGE DAMAGE ETC 6 8

PROCEDURE FOR WRITING OFF STORES 6 9

DISPOSAL OF WRITTEN OFF ARTICLES 7 1

FORMATS TO BE USED 7 3 - 81

32

STORAGE AND STOCK MANAGEMENT The expiry periods of pharmaceutical products have meaning only if the products are stored under proper conditions otherwise products are likely to lose their potency before the actual date of expiry

A pharmacist is a vital link in the distribution chain for pharmaceutical products The medicinal products remain for a long period during the distribution cycle at the wholesaler and at retail pharmacies It is therefore very important to maintain proper storage conditions in these units

Every community pharmacy however large or s mall needs to store and manage its medicine stocks effectively There must be systems to ensure

middot bullbull Secure storage middot bullbull Clean and correct environmental conditions during storage middot bullbull Accurate and effective record keeping middot bullbull Effective stock rotation and expiry monitoring middot bullbull Effective fire and theft prevention middot bullbull Effective rodent pest control

For easier un derstanding this module has been divided into the following sections

1 Quarantine and checking of stocks 11 Quarantine area 12 Checks to be carried out on new stocks

2 S t o r a g e 21 Need for proper storage 22 Different patterns of storage 23 Different means of storage 24 Temperatureclimatic conditions 25 Special storage of supplies 26 Storage and stability of medicines

3 Stock Control and Expiry Monitoring 31 Stock control 3 2 S t o c k r o t a t i o n a n d e x p i r y m o n i t o r i n g

4 Other aspects of s t o r a g e 41 Design of a storage area 42 Cleaning and maintenance 43 Product recalls 44 Returned goods

33

1 QUARANTINE AND CHECKING OF STOCKS

11 Quarantine Area D r u g S t o r e pharmacies receive stoc k s f r o m su pplie r s a c c or d ing to pur c h a se o r d e r s T he stock that is received must be visually checked for quality and quantity The stocks must be kept in a separate area until the checking is done to avoid intermixing with existing stock This necessitates the presence of a separate area within the pharmacy w h e r e i n t h e storage and other checking of stocks can be performed This area is called the QUARANTINE AREA This area should be marked and identified adequately to distinguish it from other areas

The area may be marked using different means 1 ) A s m a l l board saying Quarantine on a separate table used exclusively if it is in the middle 2) A board on the wall if the table on which the quarantine stock is placed is against the wall

middot Stock received from wholesalers should be immediately transferred t o t h e Quarantine Area

middot In the Quarantine area the stock may be stored on racks shelves or in cupboards to prevent ingress of moisture dirt and other contaminants

middot Regular stocks from the pharmacy should not be left kept in the quarantine area Special care has to be taken in case of refrigerated medicines supplied by the suppliers so tha t the y do not remain in the quarantine area for long periods of time They should be immediately checked on receipt and transferred to areas for refrigerated storage s o a s to maintain the cold chain bull

Advantages of having a separate Quarantine Area middot Avoids cross mixing of newly arrived stock from existing stock till it is checked middot Lays stress on checking the quality of the stock received middot S to ck checking ensures t hat defective andor expired goods do not enter the storage areas

34

bullbull

bullbull

12 Checks to be carried out on new stock

Unpacking and checking stock

Supplies received should be unpacked and checked in the quarantine area Staff doing the checks should be adequatel y trained in what they have to check when stock arrives

Checking should be seen not simply as counting the units received but as a part of the quality assurance system bullThis should include middot Visually inspecting the packaging middot Checking the integrity of containers middot V erifying the completeness and leg ibility of la b e ls ( a ppr o ve d dr u g name strength any special storage instructions and expiry date)

bull

The expiry dat e should be checked to ensure that there is adequate shelf life remaining

Supplies should be individually checked using a checklist 35

Checklists

36

The wholesaler supplying the product should be notified immediately in case of any discrepancies ( and the details should be recorded in a register) and sent in a written format to the supplier It should include middot Missing boxes or cartons middot O p en tampered boxes or cartons middot Missing supplies middot Differences in the actual quantity and the quantity shown on the packing middot Additional medicines that had not been ordered but have been supplied middot D a m a g e d b r o k e n o r p oor quality medicines middot Any other discrepancies

The purchase invoices are an important aspect to be considered The invoiced documents should be signed and filed for reference as per the Drugs and Cosmetics Act and retained for at least 3years

If the wholesaler supplies medicines as an emergency without a bill or against a delivery challan

middot The supplies should be checked for integrity and inspected for damage middot The details of supplies received should be recorded middot The supplier should be asked t o send the bill as early as possible middot When the bill is received it should be checked against the details recorded and anomalies if any should be reported to the supplier

To keep a track of the received stock maintaining a S t o c k R e c o r d C a r d c a n b e very useful The entries in the stock record card can be made while checking the stock received STOCK BIN in the stores should have Stock record card

Maintaining a stock card for every product may not be very practical for a retail pharmacy however it could be maintained for costly medicines Nowadays it is much more practical and easier to maintain records using computers

The pharmacist should ensure that medicines manufacturedmarketed by a company are received only through an authorized distribution network of that company This is important to prevent spurious and counterfeit drugs from entering the pharmacy

37

2 STORAGE 21 The need for proper storage The storage of medicines and other products is an important requirement of Good Pharmacy Pr actice Appropriate storage of medicines is essential -

middot bullTo ensure that the potency is maintained middot bullTo prevent deteriorationspoilagedegradation middot bullTo ensuremaintain physical integrity

To ascertain that the quality and safety is maintained throughout their shelf life Storage requirements need to be considered on 2 aspects

a) Integrity of medicines Medicines should be stored in such a way so as to maintain their integrity and potency middot Maintain the right temperature required middot Protect from excessive humidity middot Keep medicines away from direct sunlight middot Protect from pests and rodents

b) Physical location middot Should be easy to locate middot Accessible middot Orderlysystematically placed

2 2 D i f f e r e n t p a t t e r n s o f s t o r a g e The pharmacist could follow any of the different patterns of storage The pattern of stora ge should be selected in such a way that it facilitates speedy and efficient dispensing of medicines

The pattern of storage could vary with each pharmacy experience usual practiceroutine of staff and the person-in charge and also depending on space av ailable turnover etc (i) The medicines could be stored c o m p a n y w i s e ie the medicines manufactured by one company should be grouped together and kept in one place Within each company shelfshelves the medicines may be placed in alphabetical order for easy and quick placement and removal Also bottles tubes boxes etc may be segregated within that shelf

38

(ii) The medicines may also be stored in a lphabe t ic al o r de r ie they are placed in order from left to right based on their name The first letter of the name is used to g r o u p t h e m e d i c i n e s t o g e t h e r a n d k e e p t h e m i n o n e l o c a t i o n I n s o m e p h a r m a c i e s a l l t h e strip packing are placed in drawers or boxes in alphabetical order each box or drawer containing strips of one particular alphabet This system ensures that the strips always remain e n c l o s e d i n t h e b o x e s d r a w e r s a n d a r e n o t e x p o s e d t o d u s t T h e d i s a d v a n t a g e i s that it might lead to mix -u p o f strips in the same drawer and it may cause a problem incase of similar looking strips in which case a wrong medicine may be dispensed Secondly cut strips lying around in the drawer may lose their identity if the batch n u m b e r andor expiry date is not seen on the cut portion of the strip

39

(iii) The medicines may be stored according to their therapeutic class ( e g a n t i b i o t i c s anti asthmatics or anti hypertensives) ie the medicines are kept together based on their pharmacological or therapeutic action

(iv) The medicines may be stockedsegregated according to dosage forms eg l i q u i d s (bottles) solid oral dosage forms eye drops rotacaps ointments etc all stored on separate shelves

Always Remember I Storage of prescription medicines should preferably be separate from OTC medicines OTC medicines especially those that a r e a d v e r t i s e d m a y b e d i s p l a y e d f o r c l i e n t s t o select or to ask questions about [OTC-O v e r t h e c o u n t e r ] II Storage according to temperatures is a must no matter which pattern of storage is followed Also within a particular storage area segregated storage may be maintained In a refrigerator for example medicines may be stored in trays racks and the freezer according to the temperature required

40

Whatever pattern of storage is selected all the personnel should ensure that middot The stocks are stored in an orderly manner middot The medicines are kept back in the same place from where they were removed middot All medicines are arranged neatly once in a while

middot The personnel should be careful while storing the medicines middot They should not throw the medicines haphazardly 23 Different means of storage

middot Within each temperature and security zone medicines must be stored so that they are easily accessible and protected against damage

middot Basic means of storage include shelves racks and drawers middot To prevent dust from entering the shelvesracks it is ideal to have glass

shutterssliding glass doors This can however be disadvantageous because accessibilityspeed is hampered in removing a product from the shelf because the glassshuttersliding glass has to be

41

opened m o v e d e v e r y t i m e a p r o d u c t h a s t o b e p i c k e d u p U s e o f a i r c o n d i t i o n e r s f o r t h e p h arm acy with a closed door at the e n t r a n c e o r a n a i r c u r t a i n c a n r e d u c e t h e d u s t problem In such cases the shelvesracks may be left o p e n

bull

middot Direct storage of cartons on the floor should be avoided because besides being an unhealthy practice the contents may also be damaged by moisture bull

middot Store medicines preferably in shelves with glass shutters for visibility middot Closed shelves further prevent dust from going in especially in India where most

pharmacies are located along busy roads middot Some medicines have to be refrigerated or stored in a cool or cold place Having a

refrigerator or two (as per the need of the pharmacy) is essential to store suc h medicines at temperatures mentioned on the label bull

42

Refrigeration middot All cold chain equipment should meet required standards middot Improvement in refrigeration technology has provided frost -free refrigerators

Pharmacists should opt for frost-free refrigerators as they are easy to maintain and protect printed packaging materials Conventional refrigerators may cause water falling from trays below the freezer on medicines stored in the refrigerator thus causing soggy labels

middot bull Frost-free refrigerators also provide separate and large compartments for the freezer portion (required for storing medicines needing sub-z e r o t e m p e r a t u r e ) and the main storage area with separate doors so that opening one door does not disturb the storage temperature in the other compartment

Care should be taken to keep the refrigerator on 24 hours a day It should not be switched off after working hours It is advisable to have an inverter connected to the refrigerator so that the refrigerator re mains working even when there is a power outage

middot The refrigerator door should be closed tightly middot The refrigerator door should not be left open for too long middot Space should be left between medicines stored in a refrigerator to allow air to

circulate middot The ref rigerator should be placed about an arms length away from the wall

This will increase air circulation thus not affecting the cooling within the refrigerator

middot Vaccines should not be stored on refrigerator door shelves as they are exposed to warmer temperatures each time the door is opened Vaccines should always be stored on the middle shelves of the refrigerator

middot Refrigerated medicines should not be left out of the refrigerator for more than a few minutes

43

middot Consumable products like juices energy drinks e t c s h o u l d n o t b e s t o r e d a l o n g with medicines in refrigerators If required they may be kept in a separate refrigerator

middot An adequate number of refrigerators should be planned to store the entire stocks requiring refrigerated storage

middot Adequate procedures should be followed for defrosting cleaning and maintenance of refrigerators

middot Icefreeze packs should be kept in the freezer compartment so that they can be used for transporting cold temperature medicines The packs can be given to clients along with the medicines requiring cold temperature storage so that the temperature is maintained till the client reaches home and can then put the medicines in a refrigerator) Freezer packs can also be used to keep medicines temporarily in case there is a power outage or refrigerator breakdown

Activity

Prepare a SOP (Standard operating procedure chart) for cleaning a refrigerator Discuss it with your staff finalize its maintenance once a month through AMC -A n n u a l Maintenance contract CMC - Comprehensive maintenance contract and put it up on the pharmacy refrigerator Put the Purchase Order details name of manufacturer Phone of Service Engineer and a register to login the Machine service and down timeService reports may be maintained properly

Refrigerator monitoring and maintenance

middot bullIt is important to carry out routine monitoring and maintenance of the refrigerators and to organize an effective repair system

middot bullThe temperature in the refrigerator must be monitored and recorded routinely at least once a day

middot Any breakdown must be reco rded including the period during which the medicines were exposed to uncontrolled temperatures Medicines may then be kept or discarded depending on the problem guidelines or the manufacturers advice

middot Cold chain monitor cards and devices in or on packages that change color or otherwise alert staff to potential damage assist in monitoring (These are likely to be introduced in India soon)

middot It is essential to have a contingency plan in place before a refrigerator breaks down An arrangement can be made to move the contents to a private refrigerator elsewhere in the community or to obtain a regular supply of ice packs until the defect is rectified

Put filled water bottles in the bottom half of the refrigerator door in order to provide cooling in the refri g e r a t o r w h e n t h e r e i s a p o w e r o u t a g e T h i s m i g h t t a k e c a r e o f t h e temperature when there is no current for a couple of hours If the power outage is expected to last for several hours special arrangements such as an inverter UPS have to be made to keep the refrigerator constantly running in the absence of electricity middot Defrost the refrigerator in case of excessive ice formation and preferably at regular

intervals Keep a record of the same

44

2 4 T e m p e r a t u r e c l i m a t i c c o n d i t i o n s

i) Temperature control middot The medicines in a pharmacy need to be stored at appropriate temperatures to

maintain their stability middot An air-conditioned environment where temperature can be controlled is

recommended for pharmacies Air conditioning offers the option of setting the t e m p e rature as per requirements

middot bullIt is ideal to have an air conditioner to maintain the temperature below 25 C as most medicines require storage below this temperature Secondly this temperature is pleasing to both the staff and the visiting customers too

middot In the absence of an air conditioner circulating fans may be used middot This need is felt even more in certain parts of India where temperatures soar above 45

C and some areas where it falls to sub zero temperatures In such cases temperature maintenance is essential to prevent deterioration of medicines due to unnecessary exposure to drastic temperature fluctuations

middot This need is felt even more in certain parts of India where temperatures soar above 45 C and some areas where it falls to sub zero temperat u r e s I n s u c h c a s e s temperature maintenance is essential to prevent deterioration of medicines due to unnecessary exposure to drastic temperature fluctuations

i i ) Humidity or moisture control Moisture or humidity can adversely affect the stability of me dicines such as tablets capsules powders

45

Gelatin capsules become soft and swell on absorption of moisture The drug content of tablets may undergo surface hydrolysis The presence of moisture may encourage the growth of microbes It is therefore essential to control humidity

To reduce the effect of humidity the following suggestions may be followed -middot Open the windows to allow air circulation Use a fan to circulate fresh (outside) air middot In humid climate a dehumidifier is useful for preventing mo i s t u r e d a m a g e ( i n t h e absence of an air conditioner) middot For bulk containers of tabletscapsules do not keep the container open for a long time and replace the lid or closure immediately after taking out the required number of medicines for dispensing middot Do not allow the medicines to touch the floor or the walls The walls may be damp and may cause moisture absorption damaging the product

middot Calibrated thermometers and manometers can be used to detect temperature and humidity in the pharmacy

middot Periodici t y of checking the temperature should be fixed middot The climatic conditions should be recorded and documented middot Temperature charts should be available for ready reference

Documentation is one of the core activities for achieving and maintaining quality It is one of the most essential components of validation Temperatures in various areas

46

including refrigerators should be recorded at a predetermined periodicity usually daily at the hottest time of the day and such documents should be preserved i i i ) Storage conditions A number of storage conditions are mentioned on the labels of medicinal products These conditions have to be properly interpreted and appropriately complied with

According to the Drugs and Cosmetics Rules 1945

1 The term cool place means a place having a temperature between 10 C and 25 C

2 The term cold place means a place having a temperature not exceeding 8 C In case of storage conditions for specific products please refer to Schedule P The Drugs and Cosmetic Rules 1 9 4 5

The Indian Pharmacopoeia specifies the following storage conditions -

Wherever the condition for storage is not specified medicines may be stored under normal temperature In a country like India however where normal temperatures soar to h i gh temperatures it is recommended that medicines be stored in a cool place

Activity Prepare a list of the storage requirements mentioned on the label of about 20 products in your pharmacy and check if the temperature is maintained

47

25 Special Storage o f s u p p l i e s If the product has no special instructions normal storage conditions apply This means storage in dry clean w e l l -ventilated premises at temperatures of +15 C to +25 C or depending on the climate up to +30 C (WHO1990) Storage instructions are product specific Different brands of the same generic drug may have different storage requirements as they may have different packaging or formulations It is essential to follow the product manufacturers storage instructions to the maximum extent possible Less stable medicines must be stored in specific conditions to maintain their quality or potency

The following products require special storage facilities

middot Products that must be kept frozen (usually vaccines and sera) middot Products sensitive to h eat an d r e q uir in g r e f r ig e r a tio n ( +2 C to +8 C) middot Products that have reduced shelf life at uncontrolled room temperature and need

mechanical ventilation or air conditioning middot Flammable products that require separate fireproof premises middot Products prone to theft o r m i s u s e

Products needing storage in a controlled environment -

The usable shelf life of the following products may be reduced if stored at uncontrolled humidity or at room temperature in hot climates -

middot Some injectables (eg adrenaline) Most injectable preparations are less stable than solid oral forms (tablets and capsules) Injectable preparations in solution are particularly unstable Many injections must be protected from light as well as heat

middot Intravenous fluids (particularly if packed in p lastic containers) middot Some suppositories pessaries creams and ointments These products may melt at

temperatures greater than 30 C Once this happens it is not advisable to use them because the active ingredient in the formula may get unevenly distributed

middot Products containing rubber latex cellulose or some plastics Condoms most sterile disposable medical devices and surgical products such as syringes needles and catheters require protection from excessive humidity and strong light and heat Any o f these conditions may make products brittle stained amp unusable Sterility cannot be assumed if packaging is damaged

In hot climates these products should be stored in the coolest place possible preferably with air conditioning or air circulation fans

48

Products needing freezing or refrigeration-middot Vaccines blood products and many other medicines lose potency if kept even for a

brief period at temperatures outside the recommended range For these products the cold chain must be maintained at every stage of the distribution system

middot Freezing is as damaging as high temperatures for some products including injectable contraceptives ergometrine insulin adrenaline and the DPT DT TT and Hepatitis B vaccines Such products therefore sho uld not be allowed to freeze (not be kept in the freezer compartment)

middot Short periods at room temperature (during transportation or local distribution for instance) may be acceptable for many products (such as ergometrine a n d i n s u l i n ) e v e n t h o u g h s u c h e x posure can to some extent reduce shelf life Other items such as vaccines should always be transported in cold boxes

Storage of insulin injections-

middot Insulin should always be stored in a refrigerator at the recommended temperature of 2 -8 C

middot Insulin should not be kept in the freezer compartment of the refrigerator middot Insulin should ideally be stored horizontally middot It should not be exposed to sunlight or excessive heat middot Insulin suspensions should not be used if the suspension cannot be properly

resuspended due to cake or clump formationbull

Controlled drugs -Narcotics (for example Pethidine injection morphine preparations) and other specified drugs that may be abused are governed by special legislation and regulations The following security measures are suggested in the pharmacy -middot A safe or reinforced double locked cabinet fitted with a light (preferably with a red

bulb) that comes on when the door is opened

49

middot A special register recording details of each receipt or issue with 2 signatures physi cal counting of medicines after each entry and signatures at handover takeover

middot Independent audit (by supervisors and drug inspectors)

Products prone to theft abuse or misuse -

Some medicinesproducts are particularly prone to theft abuse or misuse These include expensive medicines (eg insulin) certain antibiotics and products prone to abuse or misuse like psychotropics etc

Such medicinesproducts should be stored adequately They require stricter record keeping and more frequent stock taki ng than others Periodic audits should be carried out to check for consumption against actual recorded use (registers prescription records stock records etc) to expose any theft or misuse bull26 Storage and stability of medicines Medicines are not stab le indefinitely They are stable for a specific period of time sometimes for a brief period Poor storage conditions accelerate the drug degradation (decomposition) Temperature light and moisture are the most important contributing factors for drug instability It is important to identify and be aware of the potential for instability There is a need to comply with storage requirements to ensure quality medicines for patients It is also important to offer advice to patients too about appropriate storage o f medicines at home The dispensing label should state the storage condition required and be backed up by a verbal reminder especially where special storage is required bull

50

In case stability and storage problems are seen with formulations they should be reported immediately to the representative of the manufacturer and taken out of circulation till the stability problems have been resolved

The pharmacist can easily detect stability problems when products show change in appearance color odor settling of the product contents breaking of emulsions melting of creams oozing of contents from the containers and any such physical changes

3 STOCK CONTROL AND EXPIRY MONITORING 3 1 S t o c k C o n t r o l For economic reasons pharmacists do not like to have stock on their shelves for long periods of time The aim should always be to keep stock at a level that will just meet demand Normally most manufactured medicines have a long shelf life Even then it is essential that there is efficient stock rot ation so that the older stock is used first It is also a good practice to check the expiry date as an integral part of the dispensing process When short shelf life products are involved stock levels may have to be modified to prevent medicines regularl y expiring on the shelves

32 Stock rotation and expiry monitoring In order to avoid accumulation of expired and obsolete stock medicines should be stored and issued according to the following guidelines -middot The stock control system must record the ex p i r y d a t e a n d t h e d a t e o f r e c e i p t middot Stock must be stored so that earliest expiring batches are picked and issued first middot The First In First Out (FIFO) system - In this system the stock which is received

first is sold first This system however may not be useful for pharmacies because most of the stocks carry an expiry date For pharmacies the FEFO system is more practical

51

middot The First Expiry First Out (FEFO) system - In this system the stock having an earlier expiry is sold first The stock with longer shelf life should be placed farthest to the back (or at the bottom in case o f sta c k e d b oxe s) T h is is pa r tic u la r ly impor ta n t with products that have short shelf lives such as vaccines some vitamins antibiotics etc and reduces losses due to expiry

middot E x p i r y dates should be noted on the stock record upon receipt Stock nearing expiry should not be accepted unless it can be used before expiry

Computerization and expiry monitoring In the pharmacy computerization facilitates both checking stocks and expiry mo nitoring and helps-bullbullKeeping a check on products nearing expiry bullbullKeeping a check on non- moving and slow moving products bullbullTo facilitate the removal of medicines nearing expiry from shelves in time to send them back to the wholesaler or supplier

Periodic checking for expiry The expiry date for medicinal products is a critical aspect in pharmaceutical dispensing and due importance should be given to it Periodic checking for expiry of medicines will ensure that the patient will never receive products that have crossed their expiry date During periodical checking of expiry the personnel involved should remove medicines that are nearing expiry bullbullIn -house threshold periods should be set and followed for retrieval of such medicines from the shelves bullbullSuch medicines should be stored separately These should either be dispensed immediately (thus ensuring that they are used before the expiry date) o r t h e y s h o u l d b e returned to the suppliers bullbullA separate area should be designated (cupboard or shelf)marked[FROZEN ZONE] which is adequately marked EXPIRED GOODS- NOT FOR SALE to store all expired stocks FROZEN ZONE

52

Remember Expired medicines are a NATIONAL WASTE So stock only what you can sell Avoid expiries save precious medicines for the nation

Treatment and disposing of expired medicines bullbullProcedures need to be in place for the treatment of expired medicines bullbullThe expired medicines need to be collected and be sent back to the supplier or company for appropriate disposal bullbullRecords must be maintained for expired medicines and how they are disposed off bullbullIn case of medicines that are not returnable to suppliers procedures for disposal need to be followed by the pharmacy in conjunction with the FDA The following procedure can be followed if medicines cannot be returned to suppliers ( T h e b a s i c p h i l o s o p h y of appropriate disposal is to prevent their re- circulation and use) bullbullC u t t h e c o n t ainer in such a manner that the label is also cut In case of tablets and c a p s u l e s d e s t r o y them by disposing them in a bucket of water bullbullUse landfill procedures (deep burial into the ground as per stipulations of Medical Waste Disposal Act prevalent in the respective state) bullbullPour the liquids into the sink and wash away with sufficient quantity of water bullbullKeep a record of such disposal with full details of medicines destroyed Although these measures are usually adopted care has to be taken with such tr e a t m e n t a s studies have shown that flushing of medicines has resulted in tracessmall quantities of medicines being found in waterways and groundwater having potential health and environmental effects

4 O T H E R A S P E C T S 41 Design of storage areas The following important factors need to be considered in design of storage areas -middot The retail outlets in hot areas in summers should be air-conditioned Similarly in

a r e a s o f e x t r e m e c o l d t h e p r e m i s e s w o u l d r e q u i r e w a r m i n g e s p e c i a l l y i n w i n t e r s t o maintain cool temperatures The placement of air -conditioners and heating devices should be such that medicines are not directly exposed to the cold or heat

middot Due consideration should be given to storage requirements of formulations while designing shelves and cupboards in retail outlets Sufficient shelf height should be provided so that all liquid products can be stored vertically As far as possible the shelves should be covered with glass panels to protect medicines from dust and p r e v e n t r a p i d f l u c t u a t i o n s i n temperature

middot Medicines should be stored according to the storage instructions on the labels bullIt is ideal to have a door at the pharmacy entrance to prevent dust from coming in as well as reduceprevent cooled air from going out This may not however be considered feasiblepracticable by many pharmacy owners for fear that clients may not enter the pharmacy because the door may act as a barrier An air curtain is a good alternative to a door

middot There should be minimal direct sunlight falling on the products Particular consideration should be given to premises directly facing the sun

middot bullThe arrangement of lighting in the interior of the premises should also be in a manner that the lights are not focused on the products It has been shown that light causes not only chemical damage but also can catalyze physical changes like moisture uptak e by the products Care should be taken to ensure that only diffused light falls on them

53

middot As far as possible provision should be made for a temperature and humidity indicator device in a pharmacy These devices are now easily available

middot Stability studies o f m e d i c i n e s p a c k e d i n b l i s t e r s h a v e r e v e a l e d t h a t i f t h e s e a r e exposed to light they tend to absorb moisture It is therefore necessary to store them in suitable cartons so that the blisters are not exposed to light Pharmacists should do this even if the manufacturer has not provided cartons

middot Light and temperature sensitive products should not be stored on counters where the light is intense or direct and there is no protection from temperature and humidity

42 Cleaning and maintenance i) Cleaning of storage areas

The storage areas of the pharmacy should be cleaned periodically and cleanliness should be maintained at all times The Standard Operating Procedure for cleaning should be designed and followed accordingly Schedules for cleanups should be laid down and adequate cleaning equipment should be made available

Tips for maintaining cleanliness middot Provide clean pieces of cloth for wiping at various locations in the pharmacy

Replace with clean cloth at regular intervals middot Keep separate pieces of cloth for floors shelves and medicines middot Use a disinfectant andor soap solution to clean floors middot Ensure removal of dust and prevent accumulation of dirt middot Ensure removal of cobwebs middot Use a vacuum cleaner for cleaning areas not easily reachable middot T a k e c a r e t h at breakages are handled and cleared effectively middot Observe the factors leading to waste generation in the pharmacy and take appropriate

measures to tackle the problem middot Record all cleaning procedures performed and maintain all the documents required

For ex a m p l e -bullbullThe floor of the pharmacy may be swept with a broom and swabbed with soap water every morning bullbullThe floor may be swabbed with a disinfectant every week bullbullThe entire premises including shelves and cupboards may be cleaned with a cloth (to remove dust and to check for medicines approaching expiry date or expired medicines) every three months bullbullAll the steps followed should be r e c o r d e d

The floor shelves drawers have to be cleaned and a check should be kept on dust cobwebs spillages due to breakage etc It is therefore essential to have SOPs for cleaning laying down cleaning frequencies allotting responsibilities and maintaining a daily record in the logbook to document all these activities

54

While cleaning dust settled on dosage forms like bottles tubes etc should be removed Before dispensing the products should also be wiped to remove any dust settled during storage

For refrigerators bullbullDefrosting and cleaning should be done at regular intervals bullbullSwitch off the refrigerator while cleaning bullbullCleaning should be done quickly and stocks put back immediately

i i ) Pest control Pests are a serious problem in India where insects reptiles and rodents (eg cockroaches l i z a r d s r a t s s i l v e r f i s h (Deemak - in Hindi ) etc) may find access to the pharmacy storage areas Insects like ants and borer ants may often attack wood in the pharmacy causing d am ag e to shelves cupboardsPest c ontr o l in a p h a r m a c y c a n b e a d i f f i c u l t t a s k b u t t o avoid possible contamination and physical damage to stock it is necessary to keep pests out of the pharmacy premisesPest control measures should be implemented with proper p r e c a u t i o n s t a k i n g u t m o s t c a r e t o a v o i d contamination of medicines

55

Th e following pest control measures c a n be ta ke n f r om tim e to tim e -bullbullRat bait and traps can be placed at various locations bullbullInsecticutors can be used on a permanent basis bullbullInsecticidal sprays and repellants can be used from time to time

i i i ) Fire precautions

Combustible trash such as cartons boxes and other packing waste must not be allowed to accumulate in the store Waste should be deposited in appropriate waste bins and be d i s p o s e d o f f o n a d a i l y b a s i s

F i re detection and fire fighting equipment must be maintained and regularly inspected The pharmacy personnel should receive adequate training in fire fighting techniques and emergency actionFire prevention measures should include a prominently displayed ldquoNoSmokingrdquo sign careful handling and disposal of combustible waste materials and checking of electrical connections at regular intervals

iv) Security middot Doors shutters of the pharmacy should be strong and be fitted with secure locks middot Counters should be designed so that unauthorized personnelclients do not have

access to areas where prescription medicines are stored Access to such areas should be restricted to the pharmacy staff

middot All the pharmacy staff handling supplies should be accountable for their ac t i o n s

56

middot bullSpecial care must be taken in case of Schedule X and manufactured drugs (under NDPS Act) Such medicines should be kept under lock and key and the key should be kept with the Chief Pharmacist or i n h i s a b s e n c e t h e s e n i o r p h a r m a c i s t

v) Breakagespillage and damaged product Products that have been damagedspoiled during storage and handling spillages and broken glassware should be disposed off according to procedures laid down by the pharmacy Broken and damaged products s h o u l d b e p l a c e d i n a segregated area to be returned to the supplier

vi) Inspection Senior staff should inspect all pharmacy areas regularly The shelves and drawers should b e c h e c k e d d a i l y f o r signs of pests and dust Ceiling and walls should be checked for dirt and cobwebs Stock should be checked on a regular basis for deterioration due to climatic conditions

43 Product recalls Products found to be defective should be quickly recalled (withdrawn from the market) The instructions are generally issued either by the manufacturer or the regulatory agency The level of recall is determined by both the degree of risk and the extent of distribution of the product and in India is mainly directed at the distribution chain

On receiving the details of the defective substandard spurious batchbatches of a medicine to be recalled from the manufacturer or the stockist or the FDA the pharmacy should immediately check if the particular b a t c h i s i n s t o c k a n d i f s o s u s p e n d i t s s a l e immediately

Similarly if the regulatory authority in the country bans a particular medicine or FDC the pharmacy should immediately check and remove all the different brands of that particular medicine under consideration

The details of medicines and their batches to be recalled should be available in the q u a r a n t i n e a r e a w h e r e stocks are received and checked This is to ensure that such medicines do not come into the pharmacy

middot The pharmacy should develop SOPs for recall of medicines middot The pharmacy staff should be immediately informed about such medicines and

the details should be displayed in writing in a prominent place in the pharmacy middot Rapid action helps avoid unnecessary exposure to such medicines once the

problem has been d e t e c t e d middot The progress of the recall procedure in the pharmacy should be monitored every

few days to ensure complete compliance middot All stocks of the recalled products should be stored separately from the saleable

stock These can be stored in the expiry cupboard segregated from the expired goods and be appropriately labeled ldquoRecal l e d G o o d s - Not for Salerdquo

The supplier should be notified and asked to replace defective products middot All the details of the procedures followed should be duly recorded in a Recall

Register maintained specially for the purpose The register should include d etails such as -middot Date of the recall middot Nam e of the product

57

bullbull

middot Details of the product (name of manufacturer batch number expiry date) middot Nu m b er of units purchased sold a n d sto c k in ha nd middot Reason for recall middot Nam e of the supplier to whom produc ts w e r e returned along with the date and quantity middot Name and signature of the designated personnel carrying out the recall procedure and recording details middot Name and signature of the chief pharmacist verifying the recall procedures and recording details 4 4 Returned medicines

Medicines may be returned to the pharmacy by clients due to the following reasons -bull

bullbull Unused medicines bullbull Course not completed bullbull Therapy changed by doctor bullbull Side effects experienced by patient bull

bullbull DamagedDefective medicines bullbull Missing or defaced label bullbull Missing tablets in a stripblister bullbull Leakage in bottles bullbull Leakage in strips bull

bullbull Expired medicines

Appropriate SOPs should be framed and followed for their acceptancerefusal and disposal middot bull For unused medicines returned by clients the p harmacy personnel should verify

that these were purchased from their pharmacy They should then be checked for integrity of the packing the dosage form and the expiry date and verified with the client whether they were stored in appropriate conditions This again is at the discretion of each pharmacy

middot The damageddefective medicines returned to the pharmacy should be taken back and stored separately Existing stock of the same product should be checked for similar defects

middot Expired medicines should be accepted from clients at the discretion of the pharmacist and be immediately shifted to the expired goods cupboard These can be stored segregated from the pharmacys own expired goods and be appropriately labelled ldquoExpired Goods returned by clients- Not For Salerdquo

It is advisable not to accept returned medicines requiring cold chain storage (refrigeration) because it cannot be ensured that the cold chain was maintained when the medicines were in the hands of the patientclient middot Appropriate adjustments in t he stocks should be made for medicines

returnedexchanged to update the inventory middot The medicines should then be returned to the respective shelves middot A lsquoReturned Goodsrsquo register needs to be maintained to record all details of returned

medicines

R egister should include such details as-

58

middot N a m e o f t h e p a t i e n t middot Nam e of the product and quantity r e tu r n e d middot Product details such as the batch number and expiry date middot Condition in which received middot Reason for returning products middot Compensatory measures taken wi t h r e s p e c t t o c l i e n t middot Action taken with respect to product middot Name and signature of the personnel accepting the returned medicines and recording details middot Name and signature of the chief pharmacist verifying the recorded details

What the pharmacist would have learnt from this module The storage of medicines is a critical factor in the distribution cycle bullbull Stocks received by the pharmacy should be quarantined in a separate area and necessary checks s h o u ld be performed to ascertain the qua lity a nd quantity of stocks received bullbull Whatever pattern and means of storage used the products should be stored so as to maintain their potency and integrity bullbull Storage conditions should be monitored and maintained on a regular basis bullbull Optimum stock levels should be maintained and regularly monitored for expiry bullbull The design of storage areas should facilitate appropriate storage of medicines bullbull Cleanliness should be maintained in the pharmacy bullbull Adequate measures should be taken in case of returned medicines and recalled products

Optimum storage of medicines is mandatory whether at the distribution stage at the pharmacy or ultimately within the homes of patients The pharmacist has an important r o l e t o p l a y i n t h e s t o r a g e o f m e d i c i n e s i n m a i n t a i n i n g d r u g p o t ency and efficacy and thus facilitating optimum therapeutic benefits Good Pharmacy Practice - IPA -CDSCO - WHO Appendix I Quality Assurance Templates of letters for use if found not of Standard Quality [Frozen and expired goods ]

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated To Name of the Supplier with address

Sub Not of Standard Quality GoMP-Supply of Drugs and medicines-(Codename) Return of Stocks to the Suppliers-reg(New drug policy 2009) Previous letterinvoice ref Sl No Drug Code Drug name

Manufacturing date Expiry date

Supplier address

B a t c h n o

The above items of PO nodated was drawn by the Drug Inspector (Place) on (______________date) as a statutory sampling and declared ldquoNot of Standard

59

Qualityrdquo on -(______________date) by the Government Analyst for the following reasons

- ldquoThe product sample do not confirm to IP specification for (Drug codename with respect to the content of drugrdquo

- ldquoThe product has already been blacklisted by TNMSC on -(______________date) for the failure of (quantity) of batches of drug codenamerdquo

As per the clause of the te nde r d oc um e nt ldquo I f the sa mple s d o not c onf o r m to statutory standardsthe tenderer will be liable for relevant action under the existing laws and the entire stock in such batch should be taken back by the tenderer within a period of 30 days o f t h e r e c e i p t o f t h e l e t t e r f r o m t h e v e n u e

The stock shall be taken back at the expenses of the tendererthe Procurement Authority have the right to destroy such Not of Standard Quality if the tenderer does not take back the goods within the stipulated time

The Procuring Authority will arrange to destroy the Not of Standard Quality drugs within 90 days after the expiry of 30 days mentioned above without further notice and shall also collect demurrage charges calculated at the rate of 2 per week on the value of the drugs rejected till such destructionrdquo

Hence we regret to inform you that you will have to take back the stocks available of the abovesaid batch at your own cost from the drug stores where you have supplied the above batch

Kindly acknowledge the receipt of this reference at once

P r o c u r e m e n t A u t h o r i t y Seal and Stamp

Copy to Ref No dated

1 ) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated13082010

To

Sub Frozen Drugs-ordered to return to the Suppliers-reg(New drug policy 2009) Previous letterinvoice ref

The following products which were earlier frozen have now been ordered to return to suppliers directly with permission from the State drug Authority In this regard the suppliers have been instructed to take back their failed batch from the drug store of the stores Hence you are now instructed to return the following failed batches to the suppliers by obtaining proper authorization letter and acknowledgements from them

60

Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

Kindly acknowledge the receipt of this reference at once

Procurement Authority Seal and Stamp

Copy to

Ref No dated 2) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated14092010

To

Sub Frozen Drugs-ordered to return to the Suppliers- for issue of gate pass after verification reg(New drug policy 2009) Previous letterinvoice ref

The following products which were earlier frozen have now been released Hence they may be issued Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

Kindly acknowledge the receipt of this reference at once

Procurement Authority Seal and Stamp

Copy to

61

Ref No dated 3) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated

To

Sub Stop instruction-reg(New drug policy 2009) Previous letterinvoice ref

Until further instructions stop issue all the batches of the following item Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

You must intimate the available stock in the stores of the said batch Number to the Procurement Authority immediately Also retrieve quantity if already issued

Procurement Authority Seal and Stamp

Copy to

Ref No dated 4) HOD Procurement Office of

62

Appendix II Material handling in drug stores

Rack approx rates and dimensions

S No

Item Description UOM Approx Rate

1 MEDIUM DUTY RACK SIZE 2900 H X 3090 W X 800 D IN MM (AS PER SPECIFICATION)

Each 2499800

2 MEDIUM DUTY RACK ADD ON UNIT FOR SIZE OF SR NO2

Each 2243100

To locate a Box no 3 Rack no 14 in row3

SAMPLE OF RACK no Bin numbering -------------- S a y R K 1 4 R o w 3 B o x 1 6

SAMPLE LAYOUT of RACKS in a Drug Stores

63

Sample of another warehouse of distribution warehouse system

64

65

Slotted Angle racks with bin cards

66

Plastic Pallets

Plastic pallets ar e l i g h t w e i g h t l o w- c ost and exceed industry standards for strength and durability

NOTE A pallet has bottom deckboards (see sketch) A skid does not have bottom

67

deckboards

Battery Operated Stacker

Electric Stacker Ehh (Manual Push Type) - Manual drive - Lifting electrically with Battery 12 V 88 Ah - For loading and un-loading of trucks - Battery and loading device built - in - Battery charge gauge and charging current gauge Simple and Easy Operation - Lifting and Lowering electrically direct on steering arm - Pulling and pushing through steering arm - Electrically operated relief valve on hydraulic aggregate Safe Operation - Emergency Off Switch - Constant lowering speed - Protection through lowering brake valve - Overload protection through overload brake valve - Load chains covered preventing pinching threat - Electrically interlocking during loading process - Secured battery compartment opens upwardly - Stable buffering of the steering arm in upright position - In accordance with EWG Guidelines 89 240 - In accordance with VBG 12b Prevention of Accidents

Pallet Truck [ Top ]

68

----------------------------------------------------------------------------------------------------------------------------

For Transport Of All Goods On Pallets Safe and Easy Operation - through single hand operation Lifting moving

lowering with steering handle - neutral position of the hydraulic possible - overload pressure relief valve Long Service Life - robust co n s t r u c t i o n

- special hardened axles - hardened chromium plated ram - maintenance free Easy Maneuverability - through rubber steering rollers - nylon fork rollers

A h a n d t r o l l e y

69

Trolley with plastic bins for several items del ivery

70

Digital Weighing balances

Balances amp Scales EF Seriers Precision Electronic Balance

71

1

Ice lined Refrigerators

600 litres refrigrator

72

Walk in cooler

vacuum cleaner

73

Annexure D

STOCK REGISTER FOR EXPENDABLE ITEMS Name of article

Date

From where

received with cost

Quantity Signature To whom issued Quantity Balance Signature

1 2 3 4 5 6 7 8

23

Annexure E

Receipt amp Issue Register for WARDSSECTIONS (one or more pages as per requiremnt for each medicine)

NAME OF MEDICINE RECEIPT ISSUE

DATE Quantity In Stock

Date of

Issue

Issued toMention Bed no amp

quantity (in bracket) (For

Outdoor cases give Regd No)

Balance Signature

24

Annexure -F

OUTDOOR FREE MEDICINE SLIP In Duplicate

Name of Patient Registered No Date

Sr no Name of Medicine Quantity

Seal amp sign of doctor

25

Annexure-G

TREATMENT CARD

WARD NO

NAME OF PATIENT BED NO DATE amp TIME OF ADMISSION DATE amp TIME OF DISCHARGE

DATE MEDICINES PRESCRIBED SIGNATURE

26

ANNEXURE -H

PROFORMA FOR BREAKAGE amp LOSS

NAME OF OFFICEINSTITUTION DATE PLACE

SRNO NAME amp

DESCRIPTION OF ARTICLE

COST DATE OF PURCHASE

REASON CAUSE OF BREAKAGE

RECOMMENDATION OF INVESTIGATING AUTHORITY

Signature

Orders of the Competent Authority

Signature

27

Annexure ndash I Loss- Procedure for Reporting

1 The exact nature of the defalcation 2 The full extent of loss 3 The actual period covered by the defalcation 4 The defects in the negle c t o f r u le s by w hic h the loss was rendered possible

and circumstances which facilitated the defalcation 5 The names of the officials held personally or technically directly or

indirectly and wholly or partially responsible for the irregularity c o m m i t t e d i n t h e c a s e

6 Whether the c a s e a s b e e n J u d i c i a l l y t r i e d i n a c o u r t o r n o t i f s o c o p i e s ( i n duplicate) of the Judgment may please be furnished Copy of police report may also be furnished

7 The remedial measures adopted as safeguards against the losses hereafter 8 The prospects of re covery of the loss and he action taken to effect

recovery together with the amount recovered 9 Head of Account to which the Loss is debitable may be informed

Signature of Head of Office with seal

NoteA copy of this report is to be sent to AGMPThis is as per M P Finance Code Vol I

28

STORAGE AND STOCK MANAGEMENT

29

Foreword

The New Drug Policy 2009 is being implemented in the State of Madhya Pradesh

In order to have a proper procedure for Storage maintenance and expiry management of the drugs it is necessary to follow Good Storage Practices with Standard Modules for pharmacistStore keepers

Proper guidelines on Storage Practices can lead to better Stores and inventory upkeep with medicines being properly stored in racks with proper cleanliness and hygiene

This is a step towards storage maintenance and expiry management at the various stores in the state Looking forward to see that the heads of all health facilities take benefit from this module

D ir e c t o r M e d i c a l S e r v i c e s

30

INDEX

Sr No P a r t i c u l a r s P a g e

1 S T O R A G E A N D S T O C K M A N A G E M E N T 4

1 Quarantine and checking of stocks 11 Quarantine area 12 Checks to be carried out on new stocks

2 S t o r a g e 21 Need for proper storage 22 Different patterns of storage 23 Different means of storage 24 Temperatureclimatic conditions 25 Special storage of supplies 26 Storage and stability of medicines

3 Stock Control and Expiry Monitoring 31 Stock control 32 Stock rotation and expi r y m o n i t o r i n g

4 Other aspects of storage 41 Design of a storage area 42 Cleaning and maintenance 43 Product recalls 44 Returned goods

2 A p p e n d i x 1 Templates of letters for use if found not of Standard Quality [Frozen and expired goods ]

Frozen Drugs-ordered to return to the Suppliers-reg(New drug policy 2009)

Frozen Drugs-ordered to return to the Suppliers- for issue of gate pass after verification reg(New drug policy 2009) Stop instruction-reg(New drug policy

2009) Appendix II Material handling in drug stores

31

3 PROCUREMENT ndash Government Order Relating to

the Management of Stores

(Reproduced for reference material on basic

procedure in decentralized system followed by

Health facilities in 1977)

54

F L O W C H A R T S f o r a BI R D S E Y E V I E W o f

P R O C U R E M E N T

5 5

ACQUISITION OF STORES 6 1

PLACING OF ORDERS 6 2

RECEIPT OF STORES 6 2

CUSTODY 6 3

ISSUE OF STORES Maintenance of Stock Books

6 3

PROCEDURE OF INDENTING FOR WARD amp OTHER SECTIONS OF THE INSTITUTION

6 4

HOW OFTEN TO INDENT 6 5

EMERGENT INDENT 6 5

HOW TO INDENT 6 5

KEEPING OF RECORDS IN WARDS A N D S E C T I O N S

6 6

ACCOUNTABILITY OF DRUGS BROUGHT BY THE PATIENT OR RECEIVED IN DON A T I O N BY T H E WARDSECTION _IN - CHARGE

6 7

RESPONSIBILITY OF STORES AT VARIOUS LEVELS

6 7

DISTRIBUTION OF MEDICINES FROM OUTDOOR DEPARTMENT

6 7

LOSS BREAKAGE DAMAGE ETC 6 8

PROCEDURE FOR WRITING OFF STORES 6 9

DISPOSAL OF WRITTEN OFF ARTICLES 7 1

FORMATS TO BE USED 7 3 - 81

32

STORAGE AND STOCK MANAGEMENT The expiry periods of pharmaceutical products have meaning only if the products are stored under proper conditions otherwise products are likely to lose their potency before the actual date of expiry

A pharmacist is a vital link in the distribution chain for pharmaceutical products The medicinal products remain for a long period during the distribution cycle at the wholesaler and at retail pharmacies It is therefore very important to maintain proper storage conditions in these units

Every community pharmacy however large or s mall needs to store and manage its medicine stocks effectively There must be systems to ensure

middot bullbull Secure storage middot bullbull Clean and correct environmental conditions during storage middot bullbull Accurate and effective record keeping middot bullbull Effective stock rotation and expiry monitoring middot bullbull Effective fire and theft prevention middot bullbull Effective rodent pest control

For easier un derstanding this module has been divided into the following sections

1 Quarantine and checking of stocks 11 Quarantine area 12 Checks to be carried out on new stocks

2 S t o r a g e 21 Need for proper storage 22 Different patterns of storage 23 Different means of storage 24 Temperatureclimatic conditions 25 Special storage of supplies 26 Storage and stability of medicines

3 Stock Control and Expiry Monitoring 31 Stock control 3 2 S t o c k r o t a t i o n a n d e x p i r y m o n i t o r i n g

4 Other aspects of s t o r a g e 41 Design of a storage area 42 Cleaning and maintenance 43 Product recalls 44 Returned goods

33

1 QUARANTINE AND CHECKING OF STOCKS

11 Quarantine Area D r u g S t o r e pharmacies receive stoc k s f r o m su pplie r s a c c or d ing to pur c h a se o r d e r s T he stock that is received must be visually checked for quality and quantity The stocks must be kept in a separate area until the checking is done to avoid intermixing with existing stock This necessitates the presence of a separate area within the pharmacy w h e r e i n t h e storage and other checking of stocks can be performed This area is called the QUARANTINE AREA This area should be marked and identified adequately to distinguish it from other areas

The area may be marked using different means 1 ) A s m a l l board saying Quarantine on a separate table used exclusively if it is in the middle 2) A board on the wall if the table on which the quarantine stock is placed is against the wall

middot Stock received from wholesalers should be immediately transferred t o t h e Quarantine Area

middot In the Quarantine area the stock may be stored on racks shelves or in cupboards to prevent ingress of moisture dirt and other contaminants

middot Regular stocks from the pharmacy should not be left kept in the quarantine area Special care has to be taken in case of refrigerated medicines supplied by the suppliers so tha t the y do not remain in the quarantine area for long periods of time They should be immediately checked on receipt and transferred to areas for refrigerated storage s o a s to maintain the cold chain bull

Advantages of having a separate Quarantine Area middot Avoids cross mixing of newly arrived stock from existing stock till it is checked middot Lays stress on checking the quality of the stock received middot S to ck checking ensures t hat defective andor expired goods do not enter the storage areas

34

bullbull

bullbull

12 Checks to be carried out on new stock

Unpacking and checking stock

Supplies received should be unpacked and checked in the quarantine area Staff doing the checks should be adequatel y trained in what they have to check when stock arrives

Checking should be seen not simply as counting the units received but as a part of the quality assurance system bullThis should include middot Visually inspecting the packaging middot Checking the integrity of containers middot V erifying the completeness and leg ibility of la b e ls ( a ppr o ve d dr u g name strength any special storage instructions and expiry date)

bull

The expiry dat e should be checked to ensure that there is adequate shelf life remaining

Supplies should be individually checked using a checklist 35

Checklists

36

The wholesaler supplying the product should be notified immediately in case of any discrepancies ( and the details should be recorded in a register) and sent in a written format to the supplier It should include middot Missing boxes or cartons middot O p en tampered boxes or cartons middot Missing supplies middot Differences in the actual quantity and the quantity shown on the packing middot Additional medicines that had not been ordered but have been supplied middot D a m a g e d b r o k e n o r p oor quality medicines middot Any other discrepancies

The purchase invoices are an important aspect to be considered The invoiced documents should be signed and filed for reference as per the Drugs and Cosmetics Act and retained for at least 3years

If the wholesaler supplies medicines as an emergency without a bill or against a delivery challan

middot The supplies should be checked for integrity and inspected for damage middot The details of supplies received should be recorded middot The supplier should be asked t o send the bill as early as possible middot When the bill is received it should be checked against the details recorded and anomalies if any should be reported to the supplier

To keep a track of the received stock maintaining a S t o c k R e c o r d C a r d c a n b e very useful The entries in the stock record card can be made while checking the stock received STOCK BIN in the stores should have Stock record card

Maintaining a stock card for every product may not be very practical for a retail pharmacy however it could be maintained for costly medicines Nowadays it is much more practical and easier to maintain records using computers

The pharmacist should ensure that medicines manufacturedmarketed by a company are received only through an authorized distribution network of that company This is important to prevent spurious and counterfeit drugs from entering the pharmacy

37

2 STORAGE 21 The need for proper storage The storage of medicines and other products is an important requirement of Good Pharmacy Pr actice Appropriate storage of medicines is essential -

middot bullTo ensure that the potency is maintained middot bullTo prevent deteriorationspoilagedegradation middot bullTo ensuremaintain physical integrity

To ascertain that the quality and safety is maintained throughout their shelf life Storage requirements need to be considered on 2 aspects

a) Integrity of medicines Medicines should be stored in such a way so as to maintain their integrity and potency middot Maintain the right temperature required middot Protect from excessive humidity middot Keep medicines away from direct sunlight middot Protect from pests and rodents

b) Physical location middot Should be easy to locate middot Accessible middot Orderlysystematically placed

2 2 D i f f e r e n t p a t t e r n s o f s t o r a g e The pharmacist could follow any of the different patterns of storage The pattern of stora ge should be selected in such a way that it facilitates speedy and efficient dispensing of medicines

The pattern of storage could vary with each pharmacy experience usual practiceroutine of staff and the person-in charge and also depending on space av ailable turnover etc (i) The medicines could be stored c o m p a n y w i s e ie the medicines manufactured by one company should be grouped together and kept in one place Within each company shelfshelves the medicines may be placed in alphabetical order for easy and quick placement and removal Also bottles tubes boxes etc may be segregated within that shelf

38

(ii) The medicines may also be stored in a lphabe t ic al o r de r ie they are placed in order from left to right based on their name The first letter of the name is used to g r o u p t h e m e d i c i n e s t o g e t h e r a n d k e e p t h e m i n o n e l o c a t i o n I n s o m e p h a r m a c i e s a l l t h e strip packing are placed in drawers or boxes in alphabetical order each box or drawer containing strips of one particular alphabet This system ensures that the strips always remain e n c l o s e d i n t h e b o x e s d r a w e r s a n d a r e n o t e x p o s e d t o d u s t T h e d i s a d v a n t a g e i s that it might lead to mix -u p o f strips in the same drawer and it may cause a problem incase of similar looking strips in which case a wrong medicine may be dispensed Secondly cut strips lying around in the drawer may lose their identity if the batch n u m b e r andor expiry date is not seen on the cut portion of the strip

39

(iii) The medicines may be stored according to their therapeutic class ( e g a n t i b i o t i c s anti asthmatics or anti hypertensives) ie the medicines are kept together based on their pharmacological or therapeutic action

(iv) The medicines may be stockedsegregated according to dosage forms eg l i q u i d s (bottles) solid oral dosage forms eye drops rotacaps ointments etc all stored on separate shelves

Always Remember I Storage of prescription medicines should preferably be separate from OTC medicines OTC medicines especially those that a r e a d v e r t i s e d m a y b e d i s p l a y e d f o r c l i e n t s t o select or to ask questions about [OTC-O v e r t h e c o u n t e r ] II Storage according to temperatures is a must no matter which pattern of storage is followed Also within a particular storage area segregated storage may be maintained In a refrigerator for example medicines may be stored in trays racks and the freezer according to the temperature required

40

Whatever pattern of storage is selected all the personnel should ensure that middot The stocks are stored in an orderly manner middot The medicines are kept back in the same place from where they were removed middot All medicines are arranged neatly once in a while

middot The personnel should be careful while storing the medicines middot They should not throw the medicines haphazardly 23 Different means of storage

middot Within each temperature and security zone medicines must be stored so that they are easily accessible and protected against damage

middot Basic means of storage include shelves racks and drawers middot To prevent dust from entering the shelvesracks it is ideal to have glass

shutterssliding glass doors This can however be disadvantageous because accessibilityspeed is hampered in removing a product from the shelf because the glassshuttersliding glass has to be

41

opened m o v e d e v e r y t i m e a p r o d u c t h a s t o b e p i c k e d u p U s e o f a i r c o n d i t i o n e r s f o r t h e p h arm acy with a closed door at the e n t r a n c e o r a n a i r c u r t a i n c a n r e d u c e t h e d u s t problem In such cases the shelvesracks may be left o p e n

bull

middot Direct storage of cartons on the floor should be avoided because besides being an unhealthy practice the contents may also be damaged by moisture bull

middot Store medicines preferably in shelves with glass shutters for visibility middot Closed shelves further prevent dust from going in especially in India where most

pharmacies are located along busy roads middot Some medicines have to be refrigerated or stored in a cool or cold place Having a

refrigerator or two (as per the need of the pharmacy) is essential to store suc h medicines at temperatures mentioned on the label bull

42

Refrigeration middot All cold chain equipment should meet required standards middot Improvement in refrigeration technology has provided frost -free refrigerators

Pharmacists should opt for frost-free refrigerators as they are easy to maintain and protect printed packaging materials Conventional refrigerators may cause water falling from trays below the freezer on medicines stored in the refrigerator thus causing soggy labels

middot bull Frost-free refrigerators also provide separate and large compartments for the freezer portion (required for storing medicines needing sub-z e r o t e m p e r a t u r e ) and the main storage area with separate doors so that opening one door does not disturb the storage temperature in the other compartment

Care should be taken to keep the refrigerator on 24 hours a day It should not be switched off after working hours It is advisable to have an inverter connected to the refrigerator so that the refrigerator re mains working even when there is a power outage

middot The refrigerator door should be closed tightly middot The refrigerator door should not be left open for too long middot Space should be left between medicines stored in a refrigerator to allow air to

circulate middot The ref rigerator should be placed about an arms length away from the wall

This will increase air circulation thus not affecting the cooling within the refrigerator

middot Vaccines should not be stored on refrigerator door shelves as they are exposed to warmer temperatures each time the door is opened Vaccines should always be stored on the middle shelves of the refrigerator

middot Refrigerated medicines should not be left out of the refrigerator for more than a few minutes

43

middot Consumable products like juices energy drinks e t c s h o u l d n o t b e s t o r e d a l o n g with medicines in refrigerators If required they may be kept in a separate refrigerator

middot An adequate number of refrigerators should be planned to store the entire stocks requiring refrigerated storage

middot Adequate procedures should be followed for defrosting cleaning and maintenance of refrigerators

middot Icefreeze packs should be kept in the freezer compartment so that they can be used for transporting cold temperature medicines The packs can be given to clients along with the medicines requiring cold temperature storage so that the temperature is maintained till the client reaches home and can then put the medicines in a refrigerator) Freezer packs can also be used to keep medicines temporarily in case there is a power outage or refrigerator breakdown

Activity

Prepare a SOP (Standard operating procedure chart) for cleaning a refrigerator Discuss it with your staff finalize its maintenance once a month through AMC -A n n u a l Maintenance contract CMC - Comprehensive maintenance contract and put it up on the pharmacy refrigerator Put the Purchase Order details name of manufacturer Phone of Service Engineer and a register to login the Machine service and down timeService reports may be maintained properly

Refrigerator monitoring and maintenance

middot bullIt is important to carry out routine monitoring and maintenance of the refrigerators and to organize an effective repair system

middot bullThe temperature in the refrigerator must be monitored and recorded routinely at least once a day

middot Any breakdown must be reco rded including the period during which the medicines were exposed to uncontrolled temperatures Medicines may then be kept or discarded depending on the problem guidelines or the manufacturers advice

middot Cold chain monitor cards and devices in or on packages that change color or otherwise alert staff to potential damage assist in monitoring (These are likely to be introduced in India soon)

middot It is essential to have a contingency plan in place before a refrigerator breaks down An arrangement can be made to move the contents to a private refrigerator elsewhere in the community or to obtain a regular supply of ice packs until the defect is rectified

Put filled water bottles in the bottom half of the refrigerator door in order to provide cooling in the refri g e r a t o r w h e n t h e r e i s a p o w e r o u t a g e T h i s m i g h t t a k e c a r e o f t h e temperature when there is no current for a couple of hours If the power outage is expected to last for several hours special arrangements such as an inverter UPS have to be made to keep the refrigerator constantly running in the absence of electricity middot Defrost the refrigerator in case of excessive ice formation and preferably at regular

intervals Keep a record of the same

44

2 4 T e m p e r a t u r e c l i m a t i c c o n d i t i o n s

i) Temperature control middot The medicines in a pharmacy need to be stored at appropriate temperatures to

maintain their stability middot An air-conditioned environment where temperature can be controlled is

recommended for pharmacies Air conditioning offers the option of setting the t e m p e rature as per requirements

middot bullIt is ideal to have an air conditioner to maintain the temperature below 25 C as most medicines require storage below this temperature Secondly this temperature is pleasing to both the staff and the visiting customers too

middot In the absence of an air conditioner circulating fans may be used middot This need is felt even more in certain parts of India where temperatures soar above 45

C and some areas where it falls to sub zero temperatures In such cases temperature maintenance is essential to prevent deterioration of medicines due to unnecessary exposure to drastic temperature fluctuations

middot This need is felt even more in certain parts of India where temperatures soar above 45 C and some areas where it falls to sub zero temperat u r e s I n s u c h c a s e s temperature maintenance is essential to prevent deterioration of medicines due to unnecessary exposure to drastic temperature fluctuations

i i ) Humidity or moisture control Moisture or humidity can adversely affect the stability of me dicines such as tablets capsules powders

45

Gelatin capsules become soft and swell on absorption of moisture The drug content of tablets may undergo surface hydrolysis The presence of moisture may encourage the growth of microbes It is therefore essential to control humidity

To reduce the effect of humidity the following suggestions may be followed -middot Open the windows to allow air circulation Use a fan to circulate fresh (outside) air middot In humid climate a dehumidifier is useful for preventing mo i s t u r e d a m a g e ( i n t h e absence of an air conditioner) middot For bulk containers of tabletscapsules do not keep the container open for a long time and replace the lid or closure immediately after taking out the required number of medicines for dispensing middot Do not allow the medicines to touch the floor or the walls The walls may be damp and may cause moisture absorption damaging the product

middot Calibrated thermometers and manometers can be used to detect temperature and humidity in the pharmacy

middot Periodici t y of checking the temperature should be fixed middot The climatic conditions should be recorded and documented middot Temperature charts should be available for ready reference

Documentation is one of the core activities for achieving and maintaining quality It is one of the most essential components of validation Temperatures in various areas

46

including refrigerators should be recorded at a predetermined periodicity usually daily at the hottest time of the day and such documents should be preserved i i i ) Storage conditions A number of storage conditions are mentioned on the labels of medicinal products These conditions have to be properly interpreted and appropriately complied with

According to the Drugs and Cosmetics Rules 1945

1 The term cool place means a place having a temperature between 10 C and 25 C

2 The term cold place means a place having a temperature not exceeding 8 C In case of storage conditions for specific products please refer to Schedule P The Drugs and Cosmetic Rules 1 9 4 5

The Indian Pharmacopoeia specifies the following storage conditions -

Wherever the condition for storage is not specified medicines may be stored under normal temperature In a country like India however where normal temperatures soar to h i gh temperatures it is recommended that medicines be stored in a cool place

Activity Prepare a list of the storage requirements mentioned on the label of about 20 products in your pharmacy and check if the temperature is maintained

47

25 Special Storage o f s u p p l i e s If the product has no special instructions normal storage conditions apply This means storage in dry clean w e l l -ventilated premises at temperatures of +15 C to +25 C or depending on the climate up to +30 C (WHO1990) Storage instructions are product specific Different brands of the same generic drug may have different storage requirements as they may have different packaging or formulations It is essential to follow the product manufacturers storage instructions to the maximum extent possible Less stable medicines must be stored in specific conditions to maintain their quality or potency

The following products require special storage facilities

middot Products that must be kept frozen (usually vaccines and sera) middot Products sensitive to h eat an d r e q uir in g r e f r ig e r a tio n ( +2 C to +8 C) middot Products that have reduced shelf life at uncontrolled room temperature and need

mechanical ventilation or air conditioning middot Flammable products that require separate fireproof premises middot Products prone to theft o r m i s u s e

Products needing storage in a controlled environment -

The usable shelf life of the following products may be reduced if stored at uncontrolled humidity or at room temperature in hot climates -

middot Some injectables (eg adrenaline) Most injectable preparations are less stable than solid oral forms (tablets and capsules) Injectable preparations in solution are particularly unstable Many injections must be protected from light as well as heat

middot Intravenous fluids (particularly if packed in p lastic containers) middot Some suppositories pessaries creams and ointments These products may melt at

temperatures greater than 30 C Once this happens it is not advisable to use them because the active ingredient in the formula may get unevenly distributed

middot Products containing rubber latex cellulose or some plastics Condoms most sterile disposable medical devices and surgical products such as syringes needles and catheters require protection from excessive humidity and strong light and heat Any o f these conditions may make products brittle stained amp unusable Sterility cannot be assumed if packaging is damaged

In hot climates these products should be stored in the coolest place possible preferably with air conditioning or air circulation fans

48

Products needing freezing or refrigeration-middot Vaccines blood products and many other medicines lose potency if kept even for a

brief period at temperatures outside the recommended range For these products the cold chain must be maintained at every stage of the distribution system

middot Freezing is as damaging as high temperatures for some products including injectable contraceptives ergometrine insulin adrenaline and the DPT DT TT and Hepatitis B vaccines Such products therefore sho uld not be allowed to freeze (not be kept in the freezer compartment)

middot Short periods at room temperature (during transportation or local distribution for instance) may be acceptable for many products (such as ergometrine a n d i n s u l i n ) e v e n t h o u g h s u c h e x posure can to some extent reduce shelf life Other items such as vaccines should always be transported in cold boxes

Storage of insulin injections-

middot Insulin should always be stored in a refrigerator at the recommended temperature of 2 -8 C

middot Insulin should not be kept in the freezer compartment of the refrigerator middot Insulin should ideally be stored horizontally middot It should not be exposed to sunlight or excessive heat middot Insulin suspensions should not be used if the suspension cannot be properly

resuspended due to cake or clump formationbull

Controlled drugs -Narcotics (for example Pethidine injection morphine preparations) and other specified drugs that may be abused are governed by special legislation and regulations The following security measures are suggested in the pharmacy -middot A safe or reinforced double locked cabinet fitted with a light (preferably with a red

bulb) that comes on when the door is opened

49

middot A special register recording details of each receipt or issue with 2 signatures physi cal counting of medicines after each entry and signatures at handover takeover

middot Independent audit (by supervisors and drug inspectors)

Products prone to theft abuse or misuse -

Some medicinesproducts are particularly prone to theft abuse or misuse These include expensive medicines (eg insulin) certain antibiotics and products prone to abuse or misuse like psychotropics etc

Such medicinesproducts should be stored adequately They require stricter record keeping and more frequent stock taki ng than others Periodic audits should be carried out to check for consumption against actual recorded use (registers prescription records stock records etc) to expose any theft or misuse bull26 Storage and stability of medicines Medicines are not stab le indefinitely They are stable for a specific period of time sometimes for a brief period Poor storage conditions accelerate the drug degradation (decomposition) Temperature light and moisture are the most important contributing factors for drug instability It is important to identify and be aware of the potential for instability There is a need to comply with storage requirements to ensure quality medicines for patients It is also important to offer advice to patients too about appropriate storage o f medicines at home The dispensing label should state the storage condition required and be backed up by a verbal reminder especially where special storage is required bull

50

In case stability and storage problems are seen with formulations they should be reported immediately to the representative of the manufacturer and taken out of circulation till the stability problems have been resolved

The pharmacist can easily detect stability problems when products show change in appearance color odor settling of the product contents breaking of emulsions melting of creams oozing of contents from the containers and any such physical changes

3 STOCK CONTROL AND EXPIRY MONITORING 3 1 S t o c k C o n t r o l For economic reasons pharmacists do not like to have stock on their shelves for long periods of time The aim should always be to keep stock at a level that will just meet demand Normally most manufactured medicines have a long shelf life Even then it is essential that there is efficient stock rot ation so that the older stock is used first It is also a good practice to check the expiry date as an integral part of the dispensing process When short shelf life products are involved stock levels may have to be modified to prevent medicines regularl y expiring on the shelves

32 Stock rotation and expiry monitoring In order to avoid accumulation of expired and obsolete stock medicines should be stored and issued according to the following guidelines -middot The stock control system must record the ex p i r y d a t e a n d t h e d a t e o f r e c e i p t middot Stock must be stored so that earliest expiring batches are picked and issued first middot The First In First Out (FIFO) system - In this system the stock which is received

first is sold first This system however may not be useful for pharmacies because most of the stocks carry an expiry date For pharmacies the FEFO system is more practical

51

middot The First Expiry First Out (FEFO) system - In this system the stock having an earlier expiry is sold first The stock with longer shelf life should be placed farthest to the back (or at the bottom in case o f sta c k e d b oxe s) T h is is pa r tic u la r ly impor ta n t with products that have short shelf lives such as vaccines some vitamins antibiotics etc and reduces losses due to expiry

middot E x p i r y dates should be noted on the stock record upon receipt Stock nearing expiry should not be accepted unless it can be used before expiry

Computerization and expiry monitoring In the pharmacy computerization facilitates both checking stocks and expiry mo nitoring and helps-bullbullKeeping a check on products nearing expiry bullbullKeeping a check on non- moving and slow moving products bullbullTo facilitate the removal of medicines nearing expiry from shelves in time to send them back to the wholesaler or supplier

Periodic checking for expiry The expiry date for medicinal products is a critical aspect in pharmaceutical dispensing and due importance should be given to it Periodic checking for expiry of medicines will ensure that the patient will never receive products that have crossed their expiry date During periodical checking of expiry the personnel involved should remove medicines that are nearing expiry bullbullIn -house threshold periods should be set and followed for retrieval of such medicines from the shelves bullbullSuch medicines should be stored separately These should either be dispensed immediately (thus ensuring that they are used before the expiry date) o r t h e y s h o u l d b e returned to the suppliers bullbullA separate area should be designated (cupboard or shelf)marked[FROZEN ZONE] which is adequately marked EXPIRED GOODS- NOT FOR SALE to store all expired stocks FROZEN ZONE

52

Remember Expired medicines are a NATIONAL WASTE So stock only what you can sell Avoid expiries save precious medicines for the nation

Treatment and disposing of expired medicines bullbullProcedures need to be in place for the treatment of expired medicines bullbullThe expired medicines need to be collected and be sent back to the supplier or company for appropriate disposal bullbullRecords must be maintained for expired medicines and how they are disposed off bullbullIn case of medicines that are not returnable to suppliers procedures for disposal need to be followed by the pharmacy in conjunction with the FDA The following procedure can be followed if medicines cannot be returned to suppliers ( T h e b a s i c p h i l o s o p h y of appropriate disposal is to prevent their re- circulation and use) bullbullC u t t h e c o n t ainer in such a manner that the label is also cut In case of tablets and c a p s u l e s d e s t r o y them by disposing them in a bucket of water bullbullUse landfill procedures (deep burial into the ground as per stipulations of Medical Waste Disposal Act prevalent in the respective state) bullbullPour the liquids into the sink and wash away with sufficient quantity of water bullbullKeep a record of such disposal with full details of medicines destroyed Although these measures are usually adopted care has to be taken with such tr e a t m e n t a s studies have shown that flushing of medicines has resulted in tracessmall quantities of medicines being found in waterways and groundwater having potential health and environmental effects

4 O T H E R A S P E C T S 41 Design of storage areas The following important factors need to be considered in design of storage areas -middot The retail outlets in hot areas in summers should be air-conditioned Similarly in

a r e a s o f e x t r e m e c o l d t h e p r e m i s e s w o u l d r e q u i r e w a r m i n g e s p e c i a l l y i n w i n t e r s t o maintain cool temperatures The placement of air -conditioners and heating devices should be such that medicines are not directly exposed to the cold or heat

middot Due consideration should be given to storage requirements of formulations while designing shelves and cupboards in retail outlets Sufficient shelf height should be provided so that all liquid products can be stored vertically As far as possible the shelves should be covered with glass panels to protect medicines from dust and p r e v e n t r a p i d f l u c t u a t i o n s i n temperature

middot Medicines should be stored according to the storage instructions on the labels bullIt is ideal to have a door at the pharmacy entrance to prevent dust from coming in as well as reduceprevent cooled air from going out This may not however be considered feasiblepracticable by many pharmacy owners for fear that clients may not enter the pharmacy because the door may act as a barrier An air curtain is a good alternative to a door

middot There should be minimal direct sunlight falling on the products Particular consideration should be given to premises directly facing the sun

middot bullThe arrangement of lighting in the interior of the premises should also be in a manner that the lights are not focused on the products It has been shown that light causes not only chemical damage but also can catalyze physical changes like moisture uptak e by the products Care should be taken to ensure that only diffused light falls on them

53

middot As far as possible provision should be made for a temperature and humidity indicator device in a pharmacy These devices are now easily available

middot Stability studies o f m e d i c i n e s p a c k e d i n b l i s t e r s h a v e r e v e a l e d t h a t i f t h e s e a r e exposed to light they tend to absorb moisture It is therefore necessary to store them in suitable cartons so that the blisters are not exposed to light Pharmacists should do this even if the manufacturer has not provided cartons

middot Light and temperature sensitive products should not be stored on counters where the light is intense or direct and there is no protection from temperature and humidity

42 Cleaning and maintenance i) Cleaning of storage areas

The storage areas of the pharmacy should be cleaned periodically and cleanliness should be maintained at all times The Standard Operating Procedure for cleaning should be designed and followed accordingly Schedules for cleanups should be laid down and adequate cleaning equipment should be made available

Tips for maintaining cleanliness middot Provide clean pieces of cloth for wiping at various locations in the pharmacy

Replace with clean cloth at regular intervals middot Keep separate pieces of cloth for floors shelves and medicines middot Use a disinfectant andor soap solution to clean floors middot Ensure removal of dust and prevent accumulation of dirt middot Ensure removal of cobwebs middot Use a vacuum cleaner for cleaning areas not easily reachable middot T a k e c a r e t h at breakages are handled and cleared effectively middot Observe the factors leading to waste generation in the pharmacy and take appropriate

measures to tackle the problem middot Record all cleaning procedures performed and maintain all the documents required

For ex a m p l e -bullbullThe floor of the pharmacy may be swept with a broom and swabbed with soap water every morning bullbullThe floor may be swabbed with a disinfectant every week bullbullThe entire premises including shelves and cupboards may be cleaned with a cloth (to remove dust and to check for medicines approaching expiry date or expired medicines) every three months bullbullAll the steps followed should be r e c o r d e d

The floor shelves drawers have to be cleaned and a check should be kept on dust cobwebs spillages due to breakage etc It is therefore essential to have SOPs for cleaning laying down cleaning frequencies allotting responsibilities and maintaining a daily record in the logbook to document all these activities

54

While cleaning dust settled on dosage forms like bottles tubes etc should be removed Before dispensing the products should also be wiped to remove any dust settled during storage

For refrigerators bullbullDefrosting and cleaning should be done at regular intervals bullbullSwitch off the refrigerator while cleaning bullbullCleaning should be done quickly and stocks put back immediately

i i ) Pest control Pests are a serious problem in India where insects reptiles and rodents (eg cockroaches l i z a r d s r a t s s i l v e r f i s h (Deemak - in Hindi ) etc) may find access to the pharmacy storage areas Insects like ants and borer ants may often attack wood in the pharmacy causing d am ag e to shelves cupboardsPest c ontr o l in a p h a r m a c y c a n b e a d i f f i c u l t t a s k b u t t o avoid possible contamination and physical damage to stock it is necessary to keep pests out of the pharmacy premisesPest control measures should be implemented with proper p r e c a u t i o n s t a k i n g u t m o s t c a r e t o a v o i d contamination of medicines

55

Th e following pest control measures c a n be ta ke n f r om tim e to tim e -bullbullRat bait and traps can be placed at various locations bullbullInsecticutors can be used on a permanent basis bullbullInsecticidal sprays and repellants can be used from time to time

i i i ) Fire precautions

Combustible trash such as cartons boxes and other packing waste must not be allowed to accumulate in the store Waste should be deposited in appropriate waste bins and be d i s p o s e d o f f o n a d a i l y b a s i s

F i re detection and fire fighting equipment must be maintained and regularly inspected The pharmacy personnel should receive adequate training in fire fighting techniques and emergency actionFire prevention measures should include a prominently displayed ldquoNoSmokingrdquo sign careful handling and disposal of combustible waste materials and checking of electrical connections at regular intervals

iv) Security middot Doors shutters of the pharmacy should be strong and be fitted with secure locks middot Counters should be designed so that unauthorized personnelclients do not have

access to areas where prescription medicines are stored Access to such areas should be restricted to the pharmacy staff

middot All the pharmacy staff handling supplies should be accountable for their ac t i o n s

56

middot bullSpecial care must be taken in case of Schedule X and manufactured drugs (under NDPS Act) Such medicines should be kept under lock and key and the key should be kept with the Chief Pharmacist or i n h i s a b s e n c e t h e s e n i o r p h a r m a c i s t

v) Breakagespillage and damaged product Products that have been damagedspoiled during storage and handling spillages and broken glassware should be disposed off according to procedures laid down by the pharmacy Broken and damaged products s h o u l d b e p l a c e d i n a segregated area to be returned to the supplier

vi) Inspection Senior staff should inspect all pharmacy areas regularly The shelves and drawers should b e c h e c k e d d a i l y f o r signs of pests and dust Ceiling and walls should be checked for dirt and cobwebs Stock should be checked on a regular basis for deterioration due to climatic conditions

43 Product recalls Products found to be defective should be quickly recalled (withdrawn from the market) The instructions are generally issued either by the manufacturer or the regulatory agency The level of recall is determined by both the degree of risk and the extent of distribution of the product and in India is mainly directed at the distribution chain

On receiving the details of the defective substandard spurious batchbatches of a medicine to be recalled from the manufacturer or the stockist or the FDA the pharmacy should immediately check if the particular b a t c h i s i n s t o c k a n d i f s o s u s p e n d i t s s a l e immediately

Similarly if the regulatory authority in the country bans a particular medicine or FDC the pharmacy should immediately check and remove all the different brands of that particular medicine under consideration

The details of medicines and their batches to be recalled should be available in the q u a r a n t i n e a r e a w h e r e stocks are received and checked This is to ensure that such medicines do not come into the pharmacy

middot The pharmacy should develop SOPs for recall of medicines middot The pharmacy staff should be immediately informed about such medicines and

the details should be displayed in writing in a prominent place in the pharmacy middot Rapid action helps avoid unnecessary exposure to such medicines once the

problem has been d e t e c t e d middot The progress of the recall procedure in the pharmacy should be monitored every

few days to ensure complete compliance middot All stocks of the recalled products should be stored separately from the saleable

stock These can be stored in the expiry cupboard segregated from the expired goods and be appropriately labeled ldquoRecal l e d G o o d s - Not for Salerdquo

The supplier should be notified and asked to replace defective products middot All the details of the procedures followed should be duly recorded in a Recall

Register maintained specially for the purpose The register should include d etails such as -middot Date of the recall middot Nam e of the product

57

bullbull

middot Details of the product (name of manufacturer batch number expiry date) middot Nu m b er of units purchased sold a n d sto c k in ha nd middot Reason for recall middot Nam e of the supplier to whom produc ts w e r e returned along with the date and quantity middot Name and signature of the designated personnel carrying out the recall procedure and recording details middot Name and signature of the chief pharmacist verifying the recall procedures and recording details 4 4 Returned medicines

Medicines may be returned to the pharmacy by clients due to the following reasons -bull

bullbull Unused medicines bullbull Course not completed bullbull Therapy changed by doctor bullbull Side effects experienced by patient bull

bullbull DamagedDefective medicines bullbull Missing or defaced label bullbull Missing tablets in a stripblister bullbull Leakage in bottles bullbull Leakage in strips bull

bullbull Expired medicines

Appropriate SOPs should be framed and followed for their acceptancerefusal and disposal middot bull For unused medicines returned by clients the p harmacy personnel should verify

that these were purchased from their pharmacy They should then be checked for integrity of the packing the dosage form and the expiry date and verified with the client whether they were stored in appropriate conditions This again is at the discretion of each pharmacy

middot The damageddefective medicines returned to the pharmacy should be taken back and stored separately Existing stock of the same product should be checked for similar defects

middot Expired medicines should be accepted from clients at the discretion of the pharmacist and be immediately shifted to the expired goods cupboard These can be stored segregated from the pharmacys own expired goods and be appropriately labelled ldquoExpired Goods returned by clients- Not For Salerdquo

It is advisable not to accept returned medicines requiring cold chain storage (refrigeration) because it cannot be ensured that the cold chain was maintained when the medicines were in the hands of the patientclient middot Appropriate adjustments in t he stocks should be made for medicines

returnedexchanged to update the inventory middot The medicines should then be returned to the respective shelves middot A lsquoReturned Goodsrsquo register needs to be maintained to record all details of returned

medicines

R egister should include such details as-

58

middot N a m e o f t h e p a t i e n t middot Nam e of the product and quantity r e tu r n e d middot Product details such as the batch number and expiry date middot Condition in which received middot Reason for returning products middot Compensatory measures taken wi t h r e s p e c t t o c l i e n t middot Action taken with respect to product middot Name and signature of the personnel accepting the returned medicines and recording details middot Name and signature of the chief pharmacist verifying the recorded details

What the pharmacist would have learnt from this module The storage of medicines is a critical factor in the distribution cycle bullbull Stocks received by the pharmacy should be quarantined in a separate area and necessary checks s h o u ld be performed to ascertain the qua lity a nd quantity of stocks received bullbull Whatever pattern and means of storage used the products should be stored so as to maintain their potency and integrity bullbull Storage conditions should be monitored and maintained on a regular basis bullbull Optimum stock levels should be maintained and regularly monitored for expiry bullbull The design of storage areas should facilitate appropriate storage of medicines bullbull Cleanliness should be maintained in the pharmacy bullbull Adequate measures should be taken in case of returned medicines and recalled products

Optimum storage of medicines is mandatory whether at the distribution stage at the pharmacy or ultimately within the homes of patients The pharmacist has an important r o l e t o p l a y i n t h e s t o r a g e o f m e d i c i n e s i n m a i n t a i n i n g d r u g p o t ency and efficacy and thus facilitating optimum therapeutic benefits Good Pharmacy Practice - IPA -CDSCO - WHO Appendix I Quality Assurance Templates of letters for use if found not of Standard Quality [Frozen and expired goods ]

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated To Name of the Supplier with address

Sub Not of Standard Quality GoMP-Supply of Drugs and medicines-(Codename) Return of Stocks to the Suppliers-reg(New drug policy 2009) Previous letterinvoice ref Sl No Drug Code Drug name

Manufacturing date Expiry date

Supplier address

B a t c h n o

The above items of PO nodated was drawn by the Drug Inspector (Place) on (______________date) as a statutory sampling and declared ldquoNot of Standard

59

Qualityrdquo on -(______________date) by the Government Analyst for the following reasons

- ldquoThe product sample do not confirm to IP specification for (Drug codename with respect to the content of drugrdquo

- ldquoThe product has already been blacklisted by TNMSC on -(______________date) for the failure of (quantity) of batches of drug codenamerdquo

As per the clause of the te nde r d oc um e nt ldquo I f the sa mple s d o not c onf o r m to statutory standardsthe tenderer will be liable for relevant action under the existing laws and the entire stock in such batch should be taken back by the tenderer within a period of 30 days o f t h e r e c e i p t o f t h e l e t t e r f r o m t h e v e n u e

The stock shall be taken back at the expenses of the tendererthe Procurement Authority have the right to destroy such Not of Standard Quality if the tenderer does not take back the goods within the stipulated time

The Procuring Authority will arrange to destroy the Not of Standard Quality drugs within 90 days after the expiry of 30 days mentioned above without further notice and shall also collect demurrage charges calculated at the rate of 2 per week on the value of the drugs rejected till such destructionrdquo

Hence we regret to inform you that you will have to take back the stocks available of the abovesaid batch at your own cost from the drug stores where you have supplied the above batch

Kindly acknowledge the receipt of this reference at once

P r o c u r e m e n t A u t h o r i t y Seal and Stamp

Copy to Ref No dated

1 ) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated13082010

To

Sub Frozen Drugs-ordered to return to the Suppliers-reg(New drug policy 2009) Previous letterinvoice ref

The following products which were earlier frozen have now been ordered to return to suppliers directly with permission from the State drug Authority In this regard the suppliers have been instructed to take back their failed batch from the drug store of the stores Hence you are now instructed to return the following failed batches to the suppliers by obtaining proper authorization letter and acknowledgements from them

60

Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

Kindly acknowledge the receipt of this reference at once

Procurement Authority Seal and Stamp

Copy to

Ref No dated 2) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated14092010

To

Sub Frozen Drugs-ordered to return to the Suppliers- for issue of gate pass after verification reg(New drug policy 2009) Previous letterinvoice ref

The following products which were earlier frozen have now been released Hence they may be issued Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

Kindly acknowledge the receipt of this reference at once

Procurement Authority Seal and Stamp

Copy to

61

Ref No dated 3) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated

To

Sub Stop instruction-reg(New drug policy 2009) Previous letterinvoice ref

Until further instructions stop issue all the batches of the following item Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

You must intimate the available stock in the stores of the said batch Number to the Procurement Authority immediately Also retrieve quantity if already issued

Procurement Authority Seal and Stamp

Copy to

Ref No dated 4) HOD Procurement Office of

62

Appendix II Material handling in drug stores

Rack approx rates and dimensions

S No

Item Description UOM Approx Rate

1 MEDIUM DUTY RACK SIZE 2900 H X 3090 W X 800 D IN MM (AS PER SPECIFICATION)

Each 2499800

2 MEDIUM DUTY RACK ADD ON UNIT FOR SIZE OF SR NO2

Each 2243100

To locate a Box no 3 Rack no 14 in row3

SAMPLE OF RACK no Bin numbering -------------- S a y R K 1 4 R o w 3 B o x 1 6

SAMPLE LAYOUT of RACKS in a Drug Stores

63

Sample of another warehouse of distribution warehouse system

64

65

Slotted Angle racks with bin cards

66

Plastic Pallets

Plastic pallets ar e l i g h t w e i g h t l o w- c ost and exceed industry standards for strength and durability

NOTE A pallet has bottom deckboards (see sketch) A skid does not have bottom

67

deckboards

Battery Operated Stacker

Electric Stacker Ehh (Manual Push Type) - Manual drive - Lifting electrically with Battery 12 V 88 Ah - For loading and un-loading of trucks - Battery and loading device built - in - Battery charge gauge and charging current gauge Simple and Easy Operation - Lifting and Lowering electrically direct on steering arm - Pulling and pushing through steering arm - Electrically operated relief valve on hydraulic aggregate Safe Operation - Emergency Off Switch - Constant lowering speed - Protection through lowering brake valve - Overload protection through overload brake valve - Load chains covered preventing pinching threat - Electrically interlocking during loading process - Secured battery compartment opens upwardly - Stable buffering of the steering arm in upright position - In accordance with EWG Guidelines 89 240 - In accordance with VBG 12b Prevention of Accidents

Pallet Truck [ Top ]

68

----------------------------------------------------------------------------------------------------------------------------

For Transport Of All Goods On Pallets Safe and Easy Operation - through single hand operation Lifting moving

lowering with steering handle - neutral position of the hydraulic possible - overload pressure relief valve Long Service Life - robust co n s t r u c t i o n

- special hardened axles - hardened chromium plated ram - maintenance free Easy Maneuverability - through rubber steering rollers - nylon fork rollers

A h a n d t r o l l e y

69

Trolley with plastic bins for several items del ivery

70

Digital Weighing balances

Balances amp Scales EF Seriers Precision Electronic Balance

71

1

Ice lined Refrigerators

600 litres refrigrator

72

Walk in cooler

vacuum cleaner

73

Annexure E

Receipt amp Issue Register for WARDSSECTIONS (one or more pages as per requiremnt for each medicine)

NAME OF MEDICINE RECEIPT ISSUE

DATE Quantity In Stock

Date of

Issue

Issued toMention Bed no amp

quantity (in bracket) (For

Outdoor cases give Regd No)

Balance Signature

24

Annexure -F

OUTDOOR FREE MEDICINE SLIP In Duplicate

Name of Patient Registered No Date

Sr no Name of Medicine Quantity

Seal amp sign of doctor

25

Annexure-G

TREATMENT CARD

WARD NO

NAME OF PATIENT BED NO DATE amp TIME OF ADMISSION DATE amp TIME OF DISCHARGE

DATE MEDICINES PRESCRIBED SIGNATURE

26

ANNEXURE -H

PROFORMA FOR BREAKAGE amp LOSS

NAME OF OFFICEINSTITUTION DATE PLACE

SRNO NAME amp

DESCRIPTION OF ARTICLE

COST DATE OF PURCHASE

REASON CAUSE OF BREAKAGE

RECOMMENDATION OF INVESTIGATING AUTHORITY

Signature

Orders of the Competent Authority

Signature

27

Annexure ndash I Loss- Procedure for Reporting

1 The exact nature of the defalcation 2 The full extent of loss 3 The actual period covered by the defalcation 4 The defects in the negle c t o f r u le s by w hic h the loss was rendered possible

and circumstances which facilitated the defalcation 5 The names of the officials held personally or technically directly or

indirectly and wholly or partially responsible for the irregularity c o m m i t t e d i n t h e c a s e

6 Whether the c a s e a s b e e n J u d i c i a l l y t r i e d i n a c o u r t o r n o t i f s o c o p i e s ( i n duplicate) of the Judgment may please be furnished Copy of police report may also be furnished

7 The remedial measures adopted as safeguards against the losses hereafter 8 The prospects of re covery of the loss and he action taken to effect

recovery together with the amount recovered 9 Head of Account to which the Loss is debitable may be informed

Signature of Head of Office with seal

NoteA copy of this report is to be sent to AGMPThis is as per M P Finance Code Vol I

28

STORAGE AND STOCK MANAGEMENT

29

Foreword

The New Drug Policy 2009 is being implemented in the State of Madhya Pradesh

In order to have a proper procedure for Storage maintenance and expiry management of the drugs it is necessary to follow Good Storage Practices with Standard Modules for pharmacistStore keepers

Proper guidelines on Storage Practices can lead to better Stores and inventory upkeep with medicines being properly stored in racks with proper cleanliness and hygiene

This is a step towards storage maintenance and expiry management at the various stores in the state Looking forward to see that the heads of all health facilities take benefit from this module

D ir e c t o r M e d i c a l S e r v i c e s

30

INDEX

Sr No P a r t i c u l a r s P a g e

1 S T O R A G E A N D S T O C K M A N A G E M E N T 4

1 Quarantine and checking of stocks 11 Quarantine area 12 Checks to be carried out on new stocks

2 S t o r a g e 21 Need for proper storage 22 Different patterns of storage 23 Different means of storage 24 Temperatureclimatic conditions 25 Special storage of supplies 26 Storage and stability of medicines

3 Stock Control and Expiry Monitoring 31 Stock control 32 Stock rotation and expi r y m o n i t o r i n g

4 Other aspects of storage 41 Design of a storage area 42 Cleaning and maintenance 43 Product recalls 44 Returned goods

2 A p p e n d i x 1 Templates of letters for use if found not of Standard Quality [Frozen and expired goods ]

Frozen Drugs-ordered to return to the Suppliers-reg(New drug policy 2009)

Frozen Drugs-ordered to return to the Suppliers- for issue of gate pass after verification reg(New drug policy 2009) Stop instruction-reg(New drug policy

2009) Appendix II Material handling in drug stores

31

3 PROCUREMENT ndash Government Order Relating to

the Management of Stores

(Reproduced for reference material on basic

procedure in decentralized system followed by

Health facilities in 1977)

54

F L O W C H A R T S f o r a BI R D S E Y E V I E W o f

P R O C U R E M E N T

5 5

ACQUISITION OF STORES 6 1

PLACING OF ORDERS 6 2

RECEIPT OF STORES 6 2

CUSTODY 6 3

ISSUE OF STORES Maintenance of Stock Books

6 3

PROCEDURE OF INDENTING FOR WARD amp OTHER SECTIONS OF THE INSTITUTION

6 4

HOW OFTEN TO INDENT 6 5

EMERGENT INDENT 6 5

HOW TO INDENT 6 5

KEEPING OF RECORDS IN WARDS A N D S E C T I O N S

6 6

ACCOUNTABILITY OF DRUGS BROUGHT BY THE PATIENT OR RECEIVED IN DON A T I O N BY T H E WARDSECTION _IN - CHARGE

6 7

RESPONSIBILITY OF STORES AT VARIOUS LEVELS

6 7

DISTRIBUTION OF MEDICINES FROM OUTDOOR DEPARTMENT

6 7

LOSS BREAKAGE DAMAGE ETC 6 8

PROCEDURE FOR WRITING OFF STORES 6 9

DISPOSAL OF WRITTEN OFF ARTICLES 7 1

FORMATS TO BE USED 7 3 - 81

32

STORAGE AND STOCK MANAGEMENT The expiry periods of pharmaceutical products have meaning only if the products are stored under proper conditions otherwise products are likely to lose their potency before the actual date of expiry

A pharmacist is a vital link in the distribution chain for pharmaceutical products The medicinal products remain for a long period during the distribution cycle at the wholesaler and at retail pharmacies It is therefore very important to maintain proper storage conditions in these units

Every community pharmacy however large or s mall needs to store and manage its medicine stocks effectively There must be systems to ensure

middot bullbull Secure storage middot bullbull Clean and correct environmental conditions during storage middot bullbull Accurate and effective record keeping middot bullbull Effective stock rotation and expiry monitoring middot bullbull Effective fire and theft prevention middot bullbull Effective rodent pest control

For easier un derstanding this module has been divided into the following sections

1 Quarantine and checking of stocks 11 Quarantine area 12 Checks to be carried out on new stocks

2 S t o r a g e 21 Need for proper storage 22 Different patterns of storage 23 Different means of storage 24 Temperatureclimatic conditions 25 Special storage of supplies 26 Storage and stability of medicines

3 Stock Control and Expiry Monitoring 31 Stock control 3 2 S t o c k r o t a t i o n a n d e x p i r y m o n i t o r i n g

4 Other aspects of s t o r a g e 41 Design of a storage area 42 Cleaning and maintenance 43 Product recalls 44 Returned goods

33

1 QUARANTINE AND CHECKING OF STOCKS

11 Quarantine Area D r u g S t o r e pharmacies receive stoc k s f r o m su pplie r s a c c or d ing to pur c h a se o r d e r s T he stock that is received must be visually checked for quality and quantity The stocks must be kept in a separate area until the checking is done to avoid intermixing with existing stock This necessitates the presence of a separate area within the pharmacy w h e r e i n t h e storage and other checking of stocks can be performed This area is called the QUARANTINE AREA This area should be marked and identified adequately to distinguish it from other areas

The area may be marked using different means 1 ) A s m a l l board saying Quarantine on a separate table used exclusively if it is in the middle 2) A board on the wall if the table on which the quarantine stock is placed is against the wall

middot Stock received from wholesalers should be immediately transferred t o t h e Quarantine Area

middot In the Quarantine area the stock may be stored on racks shelves or in cupboards to prevent ingress of moisture dirt and other contaminants

middot Regular stocks from the pharmacy should not be left kept in the quarantine area Special care has to be taken in case of refrigerated medicines supplied by the suppliers so tha t the y do not remain in the quarantine area for long periods of time They should be immediately checked on receipt and transferred to areas for refrigerated storage s o a s to maintain the cold chain bull

Advantages of having a separate Quarantine Area middot Avoids cross mixing of newly arrived stock from existing stock till it is checked middot Lays stress on checking the quality of the stock received middot S to ck checking ensures t hat defective andor expired goods do not enter the storage areas

34

bullbull

bullbull

12 Checks to be carried out on new stock

Unpacking and checking stock

Supplies received should be unpacked and checked in the quarantine area Staff doing the checks should be adequatel y trained in what they have to check when stock arrives

Checking should be seen not simply as counting the units received but as a part of the quality assurance system bullThis should include middot Visually inspecting the packaging middot Checking the integrity of containers middot V erifying the completeness and leg ibility of la b e ls ( a ppr o ve d dr u g name strength any special storage instructions and expiry date)

bull

The expiry dat e should be checked to ensure that there is adequate shelf life remaining

Supplies should be individually checked using a checklist 35

Checklists

36

The wholesaler supplying the product should be notified immediately in case of any discrepancies ( and the details should be recorded in a register) and sent in a written format to the supplier It should include middot Missing boxes or cartons middot O p en tampered boxes or cartons middot Missing supplies middot Differences in the actual quantity and the quantity shown on the packing middot Additional medicines that had not been ordered but have been supplied middot D a m a g e d b r o k e n o r p oor quality medicines middot Any other discrepancies

The purchase invoices are an important aspect to be considered The invoiced documents should be signed and filed for reference as per the Drugs and Cosmetics Act and retained for at least 3years

If the wholesaler supplies medicines as an emergency without a bill or against a delivery challan

middot The supplies should be checked for integrity and inspected for damage middot The details of supplies received should be recorded middot The supplier should be asked t o send the bill as early as possible middot When the bill is received it should be checked against the details recorded and anomalies if any should be reported to the supplier

To keep a track of the received stock maintaining a S t o c k R e c o r d C a r d c a n b e very useful The entries in the stock record card can be made while checking the stock received STOCK BIN in the stores should have Stock record card

Maintaining a stock card for every product may not be very practical for a retail pharmacy however it could be maintained for costly medicines Nowadays it is much more practical and easier to maintain records using computers

The pharmacist should ensure that medicines manufacturedmarketed by a company are received only through an authorized distribution network of that company This is important to prevent spurious and counterfeit drugs from entering the pharmacy

37

2 STORAGE 21 The need for proper storage The storage of medicines and other products is an important requirement of Good Pharmacy Pr actice Appropriate storage of medicines is essential -

middot bullTo ensure that the potency is maintained middot bullTo prevent deteriorationspoilagedegradation middot bullTo ensuremaintain physical integrity

To ascertain that the quality and safety is maintained throughout their shelf life Storage requirements need to be considered on 2 aspects

a) Integrity of medicines Medicines should be stored in such a way so as to maintain their integrity and potency middot Maintain the right temperature required middot Protect from excessive humidity middot Keep medicines away from direct sunlight middot Protect from pests and rodents

b) Physical location middot Should be easy to locate middot Accessible middot Orderlysystematically placed

2 2 D i f f e r e n t p a t t e r n s o f s t o r a g e The pharmacist could follow any of the different patterns of storage The pattern of stora ge should be selected in such a way that it facilitates speedy and efficient dispensing of medicines

The pattern of storage could vary with each pharmacy experience usual practiceroutine of staff and the person-in charge and also depending on space av ailable turnover etc (i) The medicines could be stored c o m p a n y w i s e ie the medicines manufactured by one company should be grouped together and kept in one place Within each company shelfshelves the medicines may be placed in alphabetical order for easy and quick placement and removal Also bottles tubes boxes etc may be segregated within that shelf

38

(ii) The medicines may also be stored in a lphabe t ic al o r de r ie they are placed in order from left to right based on their name The first letter of the name is used to g r o u p t h e m e d i c i n e s t o g e t h e r a n d k e e p t h e m i n o n e l o c a t i o n I n s o m e p h a r m a c i e s a l l t h e strip packing are placed in drawers or boxes in alphabetical order each box or drawer containing strips of one particular alphabet This system ensures that the strips always remain e n c l o s e d i n t h e b o x e s d r a w e r s a n d a r e n o t e x p o s e d t o d u s t T h e d i s a d v a n t a g e i s that it might lead to mix -u p o f strips in the same drawer and it may cause a problem incase of similar looking strips in which case a wrong medicine may be dispensed Secondly cut strips lying around in the drawer may lose their identity if the batch n u m b e r andor expiry date is not seen on the cut portion of the strip

39

(iii) The medicines may be stored according to their therapeutic class ( e g a n t i b i o t i c s anti asthmatics or anti hypertensives) ie the medicines are kept together based on their pharmacological or therapeutic action

(iv) The medicines may be stockedsegregated according to dosage forms eg l i q u i d s (bottles) solid oral dosage forms eye drops rotacaps ointments etc all stored on separate shelves

Always Remember I Storage of prescription medicines should preferably be separate from OTC medicines OTC medicines especially those that a r e a d v e r t i s e d m a y b e d i s p l a y e d f o r c l i e n t s t o select or to ask questions about [OTC-O v e r t h e c o u n t e r ] II Storage according to temperatures is a must no matter which pattern of storage is followed Also within a particular storage area segregated storage may be maintained In a refrigerator for example medicines may be stored in trays racks and the freezer according to the temperature required

40

Whatever pattern of storage is selected all the personnel should ensure that middot The stocks are stored in an orderly manner middot The medicines are kept back in the same place from where they were removed middot All medicines are arranged neatly once in a while

middot The personnel should be careful while storing the medicines middot They should not throw the medicines haphazardly 23 Different means of storage

middot Within each temperature and security zone medicines must be stored so that they are easily accessible and protected against damage

middot Basic means of storage include shelves racks and drawers middot To prevent dust from entering the shelvesracks it is ideal to have glass

shutterssliding glass doors This can however be disadvantageous because accessibilityspeed is hampered in removing a product from the shelf because the glassshuttersliding glass has to be

41

opened m o v e d e v e r y t i m e a p r o d u c t h a s t o b e p i c k e d u p U s e o f a i r c o n d i t i o n e r s f o r t h e p h arm acy with a closed door at the e n t r a n c e o r a n a i r c u r t a i n c a n r e d u c e t h e d u s t problem In such cases the shelvesracks may be left o p e n

bull

middot Direct storage of cartons on the floor should be avoided because besides being an unhealthy practice the contents may also be damaged by moisture bull

middot Store medicines preferably in shelves with glass shutters for visibility middot Closed shelves further prevent dust from going in especially in India where most

pharmacies are located along busy roads middot Some medicines have to be refrigerated or stored in a cool or cold place Having a

refrigerator or two (as per the need of the pharmacy) is essential to store suc h medicines at temperatures mentioned on the label bull

42

Refrigeration middot All cold chain equipment should meet required standards middot Improvement in refrigeration technology has provided frost -free refrigerators

Pharmacists should opt for frost-free refrigerators as they are easy to maintain and protect printed packaging materials Conventional refrigerators may cause water falling from trays below the freezer on medicines stored in the refrigerator thus causing soggy labels

middot bull Frost-free refrigerators also provide separate and large compartments for the freezer portion (required for storing medicines needing sub-z e r o t e m p e r a t u r e ) and the main storage area with separate doors so that opening one door does not disturb the storage temperature in the other compartment

Care should be taken to keep the refrigerator on 24 hours a day It should not be switched off after working hours It is advisable to have an inverter connected to the refrigerator so that the refrigerator re mains working even when there is a power outage

middot The refrigerator door should be closed tightly middot The refrigerator door should not be left open for too long middot Space should be left between medicines stored in a refrigerator to allow air to

circulate middot The ref rigerator should be placed about an arms length away from the wall

This will increase air circulation thus not affecting the cooling within the refrigerator

middot Vaccines should not be stored on refrigerator door shelves as they are exposed to warmer temperatures each time the door is opened Vaccines should always be stored on the middle shelves of the refrigerator

middot Refrigerated medicines should not be left out of the refrigerator for more than a few minutes

43

middot Consumable products like juices energy drinks e t c s h o u l d n o t b e s t o r e d a l o n g with medicines in refrigerators If required they may be kept in a separate refrigerator

middot An adequate number of refrigerators should be planned to store the entire stocks requiring refrigerated storage

middot Adequate procedures should be followed for defrosting cleaning and maintenance of refrigerators

middot Icefreeze packs should be kept in the freezer compartment so that they can be used for transporting cold temperature medicines The packs can be given to clients along with the medicines requiring cold temperature storage so that the temperature is maintained till the client reaches home and can then put the medicines in a refrigerator) Freezer packs can also be used to keep medicines temporarily in case there is a power outage or refrigerator breakdown

Activity

Prepare a SOP (Standard operating procedure chart) for cleaning a refrigerator Discuss it with your staff finalize its maintenance once a month through AMC -A n n u a l Maintenance contract CMC - Comprehensive maintenance contract and put it up on the pharmacy refrigerator Put the Purchase Order details name of manufacturer Phone of Service Engineer and a register to login the Machine service and down timeService reports may be maintained properly

Refrigerator monitoring and maintenance

middot bullIt is important to carry out routine monitoring and maintenance of the refrigerators and to organize an effective repair system

middot bullThe temperature in the refrigerator must be monitored and recorded routinely at least once a day

middot Any breakdown must be reco rded including the period during which the medicines were exposed to uncontrolled temperatures Medicines may then be kept or discarded depending on the problem guidelines or the manufacturers advice

middot Cold chain monitor cards and devices in or on packages that change color or otherwise alert staff to potential damage assist in monitoring (These are likely to be introduced in India soon)

middot It is essential to have a contingency plan in place before a refrigerator breaks down An arrangement can be made to move the contents to a private refrigerator elsewhere in the community or to obtain a regular supply of ice packs until the defect is rectified

Put filled water bottles in the bottom half of the refrigerator door in order to provide cooling in the refri g e r a t o r w h e n t h e r e i s a p o w e r o u t a g e T h i s m i g h t t a k e c a r e o f t h e temperature when there is no current for a couple of hours If the power outage is expected to last for several hours special arrangements such as an inverter UPS have to be made to keep the refrigerator constantly running in the absence of electricity middot Defrost the refrigerator in case of excessive ice formation and preferably at regular

intervals Keep a record of the same

44

2 4 T e m p e r a t u r e c l i m a t i c c o n d i t i o n s

i) Temperature control middot The medicines in a pharmacy need to be stored at appropriate temperatures to

maintain their stability middot An air-conditioned environment where temperature can be controlled is

recommended for pharmacies Air conditioning offers the option of setting the t e m p e rature as per requirements

middot bullIt is ideal to have an air conditioner to maintain the temperature below 25 C as most medicines require storage below this temperature Secondly this temperature is pleasing to both the staff and the visiting customers too

middot In the absence of an air conditioner circulating fans may be used middot This need is felt even more in certain parts of India where temperatures soar above 45

C and some areas where it falls to sub zero temperatures In such cases temperature maintenance is essential to prevent deterioration of medicines due to unnecessary exposure to drastic temperature fluctuations

middot This need is felt even more in certain parts of India where temperatures soar above 45 C and some areas where it falls to sub zero temperat u r e s I n s u c h c a s e s temperature maintenance is essential to prevent deterioration of medicines due to unnecessary exposure to drastic temperature fluctuations

i i ) Humidity or moisture control Moisture or humidity can adversely affect the stability of me dicines such as tablets capsules powders

45

Gelatin capsules become soft and swell on absorption of moisture The drug content of tablets may undergo surface hydrolysis The presence of moisture may encourage the growth of microbes It is therefore essential to control humidity

To reduce the effect of humidity the following suggestions may be followed -middot Open the windows to allow air circulation Use a fan to circulate fresh (outside) air middot In humid climate a dehumidifier is useful for preventing mo i s t u r e d a m a g e ( i n t h e absence of an air conditioner) middot For bulk containers of tabletscapsules do not keep the container open for a long time and replace the lid or closure immediately after taking out the required number of medicines for dispensing middot Do not allow the medicines to touch the floor or the walls The walls may be damp and may cause moisture absorption damaging the product

middot Calibrated thermometers and manometers can be used to detect temperature and humidity in the pharmacy

middot Periodici t y of checking the temperature should be fixed middot The climatic conditions should be recorded and documented middot Temperature charts should be available for ready reference

Documentation is one of the core activities for achieving and maintaining quality It is one of the most essential components of validation Temperatures in various areas

46

including refrigerators should be recorded at a predetermined periodicity usually daily at the hottest time of the day and such documents should be preserved i i i ) Storage conditions A number of storage conditions are mentioned on the labels of medicinal products These conditions have to be properly interpreted and appropriately complied with

According to the Drugs and Cosmetics Rules 1945

1 The term cool place means a place having a temperature between 10 C and 25 C

2 The term cold place means a place having a temperature not exceeding 8 C In case of storage conditions for specific products please refer to Schedule P The Drugs and Cosmetic Rules 1 9 4 5

The Indian Pharmacopoeia specifies the following storage conditions -

Wherever the condition for storage is not specified medicines may be stored under normal temperature In a country like India however where normal temperatures soar to h i gh temperatures it is recommended that medicines be stored in a cool place

Activity Prepare a list of the storage requirements mentioned on the label of about 20 products in your pharmacy and check if the temperature is maintained

47

25 Special Storage o f s u p p l i e s If the product has no special instructions normal storage conditions apply This means storage in dry clean w e l l -ventilated premises at temperatures of +15 C to +25 C or depending on the climate up to +30 C (WHO1990) Storage instructions are product specific Different brands of the same generic drug may have different storage requirements as they may have different packaging or formulations It is essential to follow the product manufacturers storage instructions to the maximum extent possible Less stable medicines must be stored in specific conditions to maintain their quality or potency

The following products require special storage facilities

middot Products that must be kept frozen (usually vaccines and sera) middot Products sensitive to h eat an d r e q uir in g r e f r ig e r a tio n ( +2 C to +8 C) middot Products that have reduced shelf life at uncontrolled room temperature and need

mechanical ventilation or air conditioning middot Flammable products that require separate fireproof premises middot Products prone to theft o r m i s u s e

Products needing storage in a controlled environment -

The usable shelf life of the following products may be reduced if stored at uncontrolled humidity or at room temperature in hot climates -

middot Some injectables (eg adrenaline) Most injectable preparations are less stable than solid oral forms (tablets and capsules) Injectable preparations in solution are particularly unstable Many injections must be protected from light as well as heat

middot Intravenous fluids (particularly if packed in p lastic containers) middot Some suppositories pessaries creams and ointments These products may melt at

temperatures greater than 30 C Once this happens it is not advisable to use them because the active ingredient in the formula may get unevenly distributed

middot Products containing rubber latex cellulose or some plastics Condoms most sterile disposable medical devices and surgical products such as syringes needles and catheters require protection from excessive humidity and strong light and heat Any o f these conditions may make products brittle stained amp unusable Sterility cannot be assumed if packaging is damaged

In hot climates these products should be stored in the coolest place possible preferably with air conditioning or air circulation fans

48

Products needing freezing or refrigeration-middot Vaccines blood products and many other medicines lose potency if kept even for a

brief period at temperatures outside the recommended range For these products the cold chain must be maintained at every stage of the distribution system

middot Freezing is as damaging as high temperatures for some products including injectable contraceptives ergometrine insulin adrenaline and the DPT DT TT and Hepatitis B vaccines Such products therefore sho uld not be allowed to freeze (not be kept in the freezer compartment)

middot Short periods at room temperature (during transportation or local distribution for instance) may be acceptable for many products (such as ergometrine a n d i n s u l i n ) e v e n t h o u g h s u c h e x posure can to some extent reduce shelf life Other items such as vaccines should always be transported in cold boxes

Storage of insulin injections-

middot Insulin should always be stored in a refrigerator at the recommended temperature of 2 -8 C

middot Insulin should not be kept in the freezer compartment of the refrigerator middot Insulin should ideally be stored horizontally middot It should not be exposed to sunlight or excessive heat middot Insulin suspensions should not be used if the suspension cannot be properly

resuspended due to cake or clump formationbull

Controlled drugs -Narcotics (for example Pethidine injection morphine preparations) and other specified drugs that may be abused are governed by special legislation and regulations The following security measures are suggested in the pharmacy -middot A safe or reinforced double locked cabinet fitted with a light (preferably with a red

bulb) that comes on when the door is opened

49

middot A special register recording details of each receipt or issue with 2 signatures physi cal counting of medicines after each entry and signatures at handover takeover

middot Independent audit (by supervisors and drug inspectors)

Products prone to theft abuse or misuse -

Some medicinesproducts are particularly prone to theft abuse or misuse These include expensive medicines (eg insulin) certain antibiotics and products prone to abuse or misuse like psychotropics etc

Such medicinesproducts should be stored adequately They require stricter record keeping and more frequent stock taki ng than others Periodic audits should be carried out to check for consumption against actual recorded use (registers prescription records stock records etc) to expose any theft or misuse bull26 Storage and stability of medicines Medicines are not stab le indefinitely They are stable for a specific period of time sometimes for a brief period Poor storage conditions accelerate the drug degradation (decomposition) Temperature light and moisture are the most important contributing factors for drug instability It is important to identify and be aware of the potential for instability There is a need to comply with storage requirements to ensure quality medicines for patients It is also important to offer advice to patients too about appropriate storage o f medicines at home The dispensing label should state the storage condition required and be backed up by a verbal reminder especially where special storage is required bull

50

In case stability and storage problems are seen with formulations they should be reported immediately to the representative of the manufacturer and taken out of circulation till the stability problems have been resolved

The pharmacist can easily detect stability problems when products show change in appearance color odor settling of the product contents breaking of emulsions melting of creams oozing of contents from the containers and any such physical changes

3 STOCK CONTROL AND EXPIRY MONITORING 3 1 S t o c k C o n t r o l For economic reasons pharmacists do not like to have stock on their shelves for long periods of time The aim should always be to keep stock at a level that will just meet demand Normally most manufactured medicines have a long shelf life Even then it is essential that there is efficient stock rot ation so that the older stock is used first It is also a good practice to check the expiry date as an integral part of the dispensing process When short shelf life products are involved stock levels may have to be modified to prevent medicines regularl y expiring on the shelves

32 Stock rotation and expiry monitoring In order to avoid accumulation of expired and obsolete stock medicines should be stored and issued according to the following guidelines -middot The stock control system must record the ex p i r y d a t e a n d t h e d a t e o f r e c e i p t middot Stock must be stored so that earliest expiring batches are picked and issued first middot The First In First Out (FIFO) system - In this system the stock which is received

first is sold first This system however may not be useful for pharmacies because most of the stocks carry an expiry date For pharmacies the FEFO system is more practical

51

middot The First Expiry First Out (FEFO) system - In this system the stock having an earlier expiry is sold first The stock with longer shelf life should be placed farthest to the back (or at the bottom in case o f sta c k e d b oxe s) T h is is pa r tic u la r ly impor ta n t with products that have short shelf lives such as vaccines some vitamins antibiotics etc and reduces losses due to expiry

middot E x p i r y dates should be noted on the stock record upon receipt Stock nearing expiry should not be accepted unless it can be used before expiry

Computerization and expiry monitoring In the pharmacy computerization facilitates both checking stocks and expiry mo nitoring and helps-bullbullKeeping a check on products nearing expiry bullbullKeeping a check on non- moving and slow moving products bullbullTo facilitate the removal of medicines nearing expiry from shelves in time to send them back to the wholesaler or supplier

Periodic checking for expiry The expiry date for medicinal products is a critical aspect in pharmaceutical dispensing and due importance should be given to it Periodic checking for expiry of medicines will ensure that the patient will never receive products that have crossed their expiry date During periodical checking of expiry the personnel involved should remove medicines that are nearing expiry bullbullIn -house threshold periods should be set and followed for retrieval of such medicines from the shelves bullbullSuch medicines should be stored separately These should either be dispensed immediately (thus ensuring that they are used before the expiry date) o r t h e y s h o u l d b e returned to the suppliers bullbullA separate area should be designated (cupboard or shelf)marked[FROZEN ZONE] which is adequately marked EXPIRED GOODS- NOT FOR SALE to store all expired stocks FROZEN ZONE

52

Remember Expired medicines are a NATIONAL WASTE So stock only what you can sell Avoid expiries save precious medicines for the nation

Treatment and disposing of expired medicines bullbullProcedures need to be in place for the treatment of expired medicines bullbullThe expired medicines need to be collected and be sent back to the supplier or company for appropriate disposal bullbullRecords must be maintained for expired medicines and how they are disposed off bullbullIn case of medicines that are not returnable to suppliers procedures for disposal need to be followed by the pharmacy in conjunction with the FDA The following procedure can be followed if medicines cannot be returned to suppliers ( T h e b a s i c p h i l o s o p h y of appropriate disposal is to prevent their re- circulation and use) bullbullC u t t h e c o n t ainer in such a manner that the label is also cut In case of tablets and c a p s u l e s d e s t r o y them by disposing them in a bucket of water bullbullUse landfill procedures (deep burial into the ground as per stipulations of Medical Waste Disposal Act prevalent in the respective state) bullbullPour the liquids into the sink and wash away with sufficient quantity of water bullbullKeep a record of such disposal with full details of medicines destroyed Although these measures are usually adopted care has to be taken with such tr e a t m e n t a s studies have shown that flushing of medicines has resulted in tracessmall quantities of medicines being found in waterways and groundwater having potential health and environmental effects

4 O T H E R A S P E C T S 41 Design of storage areas The following important factors need to be considered in design of storage areas -middot The retail outlets in hot areas in summers should be air-conditioned Similarly in

a r e a s o f e x t r e m e c o l d t h e p r e m i s e s w o u l d r e q u i r e w a r m i n g e s p e c i a l l y i n w i n t e r s t o maintain cool temperatures The placement of air -conditioners and heating devices should be such that medicines are not directly exposed to the cold or heat

middot Due consideration should be given to storage requirements of formulations while designing shelves and cupboards in retail outlets Sufficient shelf height should be provided so that all liquid products can be stored vertically As far as possible the shelves should be covered with glass panels to protect medicines from dust and p r e v e n t r a p i d f l u c t u a t i o n s i n temperature

middot Medicines should be stored according to the storage instructions on the labels bullIt is ideal to have a door at the pharmacy entrance to prevent dust from coming in as well as reduceprevent cooled air from going out This may not however be considered feasiblepracticable by many pharmacy owners for fear that clients may not enter the pharmacy because the door may act as a barrier An air curtain is a good alternative to a door

middot There should be minimal direct sunlight falling on the products Particular consideration should be given to premises directly facing the sun

middot bullThe arrangement of lighting in the interior of the premises should also be in a manner that the lights are not focused on the products It has been shown that light causes not only chemical damage but also can catalyze physical changes like moisture uptak e by the products Care should be taken to ensure that only diffused light falls on them

53

middot As far as possible provision should be made for a temperature and humidity indicator device in a pharmacy These devices are now easily available

middot Stability studies o f m e d i c i n e s p a c k e d i n b l i s t e r s h a v e r e v e a l e d t h a t i f t h e s e a r e exposed to light they tend to absorb moisture It is therefore necessary to store them in suitable cartons so that the blisters are not exposed to light Pharmacists should do this even if the manufacturer has not provided cartons

middot Light and temperature sensitive products should not be stored on counters where the light is intense or direct and there is no protection from temperature and humidity

42 Cleaning and maintenance i) Cleaning of storage areas

The storage areas of the pharmacy should be cleaned periodically and cleanliness should be maintained at all times The Standard Operating Procedure for cleaning should be designed and followed accordingly Schedules for cleanups should be laid down and adequate cleaning equipment should be made available

Tips for maintaining cleanliness middot Provide clean pieces of cloth for wiping at various locations in the pharmacy

Replace with clean cloth at regular intervals middot Keep separate pieces of cloth for floors shelves and medicines middot Use a disinfectant andor soap solution to clean floors middot Ensure removal of dust and prevent accumulation of dirt middot Ensure removal of cobwebs middot Use a vacuum cleaner for cleaning areas not easily reachable middot T a k e c a r e t h at breakages are handled and cleared effectively middot Observe the factors leading to waste generation in the pharmacy and take appropriate

measures to tackle the problem middot Record all cleaning procedures performed and maintain all the documents required

For ex a m p l e -bullbullThe floor of the pharmacy may be swept with a broom and swabbed with soap water every morning bullbullThe floor may be swabbed with a disinfectant every week bullbullThe entire premises including shelves and cupboards may be cleaned with a cloth (to remove dust and to check for medicines approaching expiry date or expired medicines) every three months bullbullAll the steps followed should be r e c o r d e d

The floor shelves drawers have to be cleaned and a check should be kept on dust cobwebs spillages due to breakage etc It is therefore essential to have SOPs for cleaning laying down cleaning frequencies allotting responsibilities and maintaining a daily record in the logbook to document all these activities

54

While cleaning dust settled on dosage forms like bottles tubes etc should be removed Before dispensing the products should also be wiped to remove any dust settled during storage

For refrigerators bullbullDefrosting and cleaning should be done at regular intervals bullbullSwitch off the refrigerator while cleaning bullbullCleaning should be done quickly and stocks put back immediately

i i ) Pest control Pests are a serious problem in India where insects reptiles and rodents (eg cockroaches l i z a r d s r a t s s i l v e r f i s h (Deemak - in Hindi ) etc) may find access to the pharmacy storage areas Insects like ants and borer ants may often attack wood in the pharmacy causing d am ag e to shelves cupboardsPest c ontr o l in a p h a r m a c y c a n b e a d i f f i c u l t t a s k b u t t o avoid possible contamination and physical damage to stock it is necessary to keep pests out of the pharmacy premisesPest control measures should be implemented with proper p r e c a u t i o n s t a k i n g u t m o s t c a r e t o a v o i d contamination of medicines

55

Th e following pest control measures c a n be ta ke n f r om tim e to tim e -bullbullRat bait and traps can be placed at various locations bullbullInsecticutors can be used on a permanent basis bullbullInsecticidal sprays and repellants can be used from time to time

i i i ) Fire precautions

Combustible trash such as cartons boxes and other packing waste must not be allowed to accumulate in the store Waste should be deposited in appropriate waste bins and be d i s p o s e d o f f o n a d a i l y b a s i s

F i re detection and fire fighting equipment must be maintained and regularly inspected The pharmacy personnel should receive adequate training in fire fighting techniques and emergency actionFire prevention measures should include a prominently displayed ldquoNoSmokingrdquo sign careful handling and disposal of combustible waste materials and checking of electrical connections at regular intervals

iv) Security middot Doors shutters of the pharmacy should be strong and be fitted with secure locks middot Counters should be designed so that unauthorized personnelclients do not have

access to areas where prescription medicines are stored Access to such areas should be restricted to the pharmacy staff

middot All the pharmacy staff handling supplies should be accountable for their ac t i o n s

56

middot bullSpecial care must be taken in case of Schedule X and manufactured drugs (under NDPS Act) Such medicines should be kept under lock and key and the key should be kept with the Chief Pharmacist or i n h i s a b s e n c e t h e s e n i o r p h a r m a c i s t

v) Breakagespillage and damaged product Products that have been damagedspoiled during storage and handling spillages and broken glassware should be disposed off according to procedures laid down by the pharmacy Broken and damaged products s h o u l d b e p l a c e d i n a segregated area to be returned to the supplier

vi) Inspection Senior staff should inspect all pharmacy areas regularly The shelves and drawers should b e c h e c k e d d a i l y f o r signs of pests and dust Ceiling and walls should be checked for dirt and cobwebs Stock should be checked on a regular basis for deterioration due to climatic conditions

43 Product recalls Products found to be defective should be quickly recalled (withdrawn from the market) The instructions are generally issued either by the manufacturer or the regulatory agency The level of recall is determined by both the degree of risk and the extent of distribution of the product and in India is mainly directed at the distribution chain

On receiving the details of the defective substandard spurious batchbatches of a medicine to be recalled from the manufacturer or the stockist or the FDA the pharmacy should immediately check if the particular b a t c h i s i n s t o c k a n d i f s o s u s p e n d i t s s a l e immediately

Similarly if the regulatory authority in the country bans a particular medicine or FDC the pharmacy should immediately check and remove all the different brands of that particular medicine under consideration

The details of medicines and their batches to be recalled should be available in the q u a r a n t i n e a r e a w h e r e stocks are received and checked This is to ensure that such medicines do not come into the pharmacy

middot The pharmacy should develop SOPs for recall of medicines middot The pharmacy staff should be immediately informed about such medicines and

the details should be displayed in writing in a prominent place in the pharmacy middot Rapid action helps avoid unnecessary exposure to such medicines once the

problem has been d e t e c t e d middot The progress of the recall procedure in the pharmacy should be monitored every

few days to ensure complete compliance middot All stocks of the recalled products should be stored separately from the saleable

stock These can be stored in the expiry cupboard segregated from the expired goods and be appropriately labeled ldquoRecal l e d G o o d s - Not for Salerdquo

The supplier should be notified and asked to replace defective products middot All the details of the procedures followed should be duly recorded in a Recall

Register maintained specially for the purpose The register should include d etails such as -middot Date of the recall middot Nam e of the product

57

bullbull

middot Details of the product (name of manufacturer batch number expiry date) middot Nu m b er of units purchased sold a n d sto c k in ha nd middot Reason for recall middot Nam e of the supplier to whom produc ts w e r e returned along with the date and quantity middot Name and signature of the designated personnel carrying out the recall procedure and recording details middot Name and signature of the chief pharmacist verifying the recall procedures and recording details 4 4 Returned medicines

Medicines may be returned to the pharmacy by clients due to the following reasons -bull

bullbull Unused medicines bullbull Course not completed bullbull Therapy changed by doctor bullbull Side effects experienced by patient bull

bullbull DamagedDefective medicines bullbull Missing or defaced label bullbull Missing tablets in a stripblister bullbull Leakage in bottles bullbull Leakage in strips bull

bullbull Expired medicines

Appropriate SOPs should be framed and followed for their acceptancerefusal and disposal middot bull For unused medicines returned by clients the p harmacy personnel should verify

that these were purchased from their pharmacy They should then be checked for integrity of the packing the dosage form and the expiry date and verified with the client whether they were stored in appropriate conditions This again is at the discretion of each pharmacy

middot The damageddefective medicines returned to the pharmacy should be taken back and stored separately Existing stock of the same product should be checked for similar defects

middot Expired medicines should be accepted from clients at the discretion of the pharmacist and be immediately shifted to the expired goods cupboard These can be stored segregated from the pharmacys own expired goods and be appropriately labelled ldquoExpired Goods returned by clients- Not For Salerdquo

It is advisable not to accept returned medicines requiring cold chain storage (refrigeration) because it cannot be ensured that the cold chain was maintained when the medicines were in the hands of the patientclient middot Appropriate adjustments in t he stocks should be made for medicines

returnedexchanged to update the inventory middot The medicines should then be returned to the respective shelves middot A lsquoReturned Goodsrsquo register needs to be maintained to record all details of returned

medicines

R egister should include such details as-

58

middot N a m e o f t h e p a t i e n t middot Nam e of the product and quantity r e tu r n e d middot Product details such as the batch number and expiry date middot Condition in which received middot Reason for returning products middot Compensatory measures taken wi t h r e s p e c t t o c l i e n t middot Action taken with respect to product middot Name and signature of the personnel accepting the returned medicines and recording details middot Name and signature of the chief pharmacist verifying the recorded details

What the pharmacist would have learnt from this module The storage of medicines is a critical factor in the distribution cycle bullbull Stocks received by the pharmacy should be quarantined in a separate area and necessary checks s h o u ld be performed to ascertain the qua lity a nd quantity of stocks received bullbull Whatever pattern and means of storage used the products should be stored so as to maintain their potency and integrity bullbull Storage conditions should be monitored and maintained on a regular basis bullbull Optimum stock levels should be maintained and regularly monitored for expiry bullbull The design of storage areas should facilitate appropriate storage of medicines bullbull Cleanliness should be maintained in the pharmacy bullbull Adequate measures should be taken in case of returned medicines and recalled products

Optimum storage of medicines is mandatory whether at the distribution stage at the pharmacy or ultimately within the homes of patients The pharmacist has an important r o l e t o p l a y i n t h e s t o r a g e o f m e d i c i n e s i n m a i n t a i n i n g d r u g p o t ency and efficacy and thus facilitating optimum therapeutic benefits Good Pharmacy Practice - IPA -CDSCO - WHO Appendix I Quality Assurance Templates of letters for use if found not of Standard Quality [Frozen and expired goods ]

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated To Name of the Supplier with address

Sub Not of Standard Quality GoMP-Supply of Drugs and medicines-(Codename) Return of Stocks to the Suppliers-reg(New drug policy 2009) Previous letterinvoice ref Sl No Drug Code Drug name

Manufacturing date Expiry date

Supplier address

B a t c h n o

The above items of PO nodated was drawn by the Drug Inspector (Place) on (______________date) as a statutory sampling and declared ldquoNot of Standard

59

Qualityrdquo on -(______________date) by the Government Analyst for the following reasons

- ldquoThe product sample do not confirm to IP specification for (Drug codename with respect to the content of drugrdquo

- ldquoThe product has already been blacklisted by TNMSC on -(______________date) for the failure of (quantity) of batches of drug codenamerdquo

As per the clause of the te nde r d oc um e nt ldquo I f the sa mple s d o not c onf o r m to statutory standardsthe tenderer will be liable for relevant action under the existing laws and the entire stock in such batch should be taken back by the tenderer within a period of 30 days o f t h e r e c e i p t o f t h e l e t t e r f r o m t h e v e n u e

The stock shall be taken back at the expenses of the tendererthe Procurement Authority have the right to destroy such Not of Standard Quality if the tenderer does not take back the goods within the stipulated time

The Procuring Authority will arrange to destroy the Not of Standard Quality drugs within 90 days after the expiry of 30 days mentioned above without further notice and shall also collect demurrage charges calculated at the rate of 2 per week on the value of the drugs rejected till such destructionrdquo

Hence we regret to inform you that you will have to take back the stocks available of the abovesaid batch at your own cost from the drug stores where you have supplied the above batch

Kindly acknowledge the receipt of this reference at once

P r o c u r e m e n t A u t h o r i t y Seal and Stamp

Copy to Ref No dated

1 ) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated13082010

To

Sub Frozen Drugs-ordered to return to the Suppliers-reg(New drug policy 2009) Previous letterinvoice ref

The following products which were earlier frozen have now been ordered to return to suppliers directly with permission from the State drug Authority In this regard the suppliers have been instructed to take back their failed batch from the drug store of the stores Hence you are now instructed to return the following failed batches to the suppliers by obtaining proper authorization letter and acknowledgements from them

60

Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

Kindly acknowledge the receipt of this reference at once

Procurement Authority Seal and Stamp

Copy to

Ref No dated 2) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated14092010

To

Sub Frozen Drugs-ordered to return to the Suppliers- for issue of gate pass after verification reg(New drug policy 2009) Previous letterinvoice ref

The following products which were earlier frozen have now been released Hence they may be issued Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

Kindly acknowledge the receipt of this reference at once

Procurement Authority Seal and Stamp

Copy to

61

Ref No dated 3) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated

To

Sub Stop instruction-reg(New drug policy 2009) Previous letterinvoice ref

Until further instructions stop issue all the batches of the following item Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

You must intimate the available stock in the stores of the said batch Number to the Procurement Authority immediately Also retrieve quantity if already issued

Procurement Authority Seal and Stamp

Copy to

Ref No dated 4) HOD Procurement Office of

62

Appendix II Material handling in drug stores

Rack approx rates and dimensions

S No

Item Description UOM Approx Rate

1 MEDIUM DUTY RACK SIZE 2900 H X 3090 W X 800 D IN MM (AS PER SPECIFICATION)

Each 2499800

2 MEDIUM DUTY RACK ADD ON UNIT FOR SIZE OF SR NO2

Each 2243100

To locate a Box no 3 Rack no 14 in row3

SAMPLE OF RACK no Bin numbering -------------- S a y R K 1 4 R o w 3 B o x 1 6

SAMPLE LAYOUT of RACKS in a Drug Stores

63

Sample of another warehouse of distribution warehouse system

64

65

Slotted Angle racks with bin cards

66

Plastic Pallets

Plastic pallets ar e l i g h t w e i g h t l o w- c ost and exceed industry standards for strength and durability

NOTE A pallet has bottom deckboards (see sketch) A skid does not have bottom

67

deckboards

Battery Operated Stacker

Electric Stacker Ehh (Manual Push Type) - Manual drive - Lifting electrically with Battery 12 V 88 Ah - For loading and un-loading of trucks - Battery and loading device built - in - Battery charge gauge and charging current gauge Simple and Easy Operation - Lifting and Lowering electrically direct on steering arm - Pulling and pushing through steering arm - Electrically operated relief valve on hydraulic aggregate Safe Operation - Emergency Off Switch - Constant lowering speed - Protection through lowering brake valve - Overload protection through overload brake valve - Load chains covered preventing pinching threat - Electrically interlocking during loading process - Secured battery compartment opens upwardly - Stable buffering of the steering arm in upright position - In accordance with EWG Guidelines 89 240 - In accordance with VBG 12b Prevention of Accidents

Pallet Truck [ Top ]

68

----------------------------------------------------------------------------------------------------------------------------

For Transport Of All Goods On Pallets Safe and Easy Operation - through single hand operation Lifting moving

lowering with steering handle - neutral position of the hydraulic possible - overload pressure relief valve Long Service Life - robust co n s t r u c t i o n

- special hardened axles - hardened chromium plated ram - maintenance free Easy Maneuverability - through rubber steering rollers - nylon fork rollers

A h a n d t r o l l e y

69

Trolley with plastic bins for several items del ivery

70

Digital Weighing balances

Balances amp Scales EF Seriers Precision Electronic Balance

71

1

Ice lined Refrigerators

600 litres refrigrator

72

Walk in cooler

vacuum cleaner

73

Annexure -F

OUTDOOR FREE MEDICINE SLIP In Duplicate

Name of Patient Registered No Date

Sr no Name of Medicine Quantity

Seal amp sign of doctor

25

Annexure-G

TREATMENT CARD

WARD NO

NAME OF PATIENT BED NO DATE amp TIME OF ADMISSION DATE amp TIME OF DISCHARGE

DATE MEDICINES PRESCRIBED SIGNATURE

26

ANNEXURE -H

PROFORMA FOR BREAKAGE amp LOSS

NAME OF OFFICEINSTITUTION DATE PLACE

SRNO NAME amp

DESCRIPTION OF ARTICLE

COST DATE OF PURCHASE

REASON CAUSE OF BREAKAGE

RECOMMENDATION OF INVESTIGATING AUTHORITY

Signature

Orders of the Competent Authority

Signature

27

Annexure ndash I Loss- Procedure for Reporting

1 The exact nature of the defalcation 2 The full extent of loss 3 The actual period covered by the defalcation 4 The defects in the negle c t o f r u le s by w hic h the loss was rendered possible

and circumstances which facilitated the defalcation 5 The names of the officials held personally or technically directly or

indirectly and wholly or partially responsible for the irregularity c o m m i t t e d i n t h e c a s e

6 Whether the c a s e a s b e e n J u d i c i a l l y t r i e d i n a c o u r t o r n o t i f s o c o p i e s ( i n duplicate) of the Judgment may please be furnished Copy of police report may also be furnished

7 The remedial measures adopted as safeguards against the losses hereafter 8 The prospects of re covery of the loss and he action taken to effect

recovery together with the amount recovered 9 Head of Account to which the Loss is debitable may be informed

Signature of Head of Office with seal

NoteA copy of this report is to be sent to AGMPThis is as per M P Finance Code Vol I

28

STORAGE AND STOCK MANAGEMENT

29

Foreword

The New Drug Policy 2009 is being implemented in the State of Madhya Pradesh

In order to have a proper procedure for Storage maintenance and expiry management of the drugs it is necessary to follow Good Storage Practices with Standard Modules for pharmacistStore keepers

Proper guidelines on Storage Practices can lead to better Stores and inventory upkeep with medicines being properly stored in racks with proper cleanliness and hygiene

This is a step towards storage maintenance and expiry management at the various stores in the state Looking forward to see that the heads of all health facilities take benefit from this module

D ir e c t o r M e d i c a l S e r v i c e s

30

INDEX

Sr No P a r t i c u l a r s P a g e

1 S T O R A G E A N D S T O C K M A N A G E M E N T 4

1 Quarantine and checking of stocks 11 Quarantine area 12 Checks to be carried out on new stocks

2 S t o r a g e 21 Need for proper storage 22 Different patterns of storage 23 Different means of storage 24 Temperatureclimatic conditions 25 Special storage of supplies 26 Storage and stability of medicines

3 Stock Control and Expiry Monitoring 31 Stock control 32 Stock rotation and expi r y m o n i t o r i n g

4 Other aspects of storage 41 Design of a storage area 42 Cleaning and maintenance 43 Product recalls 44 Returned goods

2 A p p e n d i x 1 Templates of letters for use if found not of Standard Quality [Frozen and expired goods ]

Frozen Drugs-ordered to return to the Suppliers-reg(New drug policy 2009)

Frozen Drugs-ordered to return to the Suppliers- for issue of gate pass after verification reg(New drug policy 2009) Stop instruction-reg(New drug policy

2009) Appendix II Material handling in drug stores

31

3 PROCUREMENT ndash Government Order Relating to

the Management of Stores

(Reproduced for reference material on basic

procedure in decentralized system followed by

Health facilities in 1977)

54

F L O W C H A R T S f o r a BI R D S E Y E V I E W o f

P R O C U R E M E N T

5 5

ACQUISITION OF STORES 6 1

PLACING OF ORDERS 6 2

RECEIPT OF STORES 6 2

CUSTODY 6 3

ISSUE OF STORES Maintenance of Stock Books

6 3

PROCEDURE OF INDENTING FOR WARD amp OTHER SECTIONS OF THE INSTITUTION

6 4

HOW OFTEN TO INDENT 6 5

EMERGENT INDENT 6 5

HOW TO INDENT 6 5

KEEPING OF RECORDS IN WARDS A N D S E C T I O N S

6 6

ACCOUNTABILITY OF DRUGS BROUGHT BY THE PATIENT OR RECEIVED IN DON A T I O N BY T H E WARDSECTION _IN - CHARGE

6 7

RESPONSIBILITY OF STORES AT VARIOUS LEVELS

6 7

DISTRIBUTION OF MEDICINES FROM OUTDOOR DEPARTMENT

6 7

LOSS BREAKAGE DAMAGE ETC 6 8

PROCEDURE FOR WRITING OFF STORES 6 9

DISPOSAL OF WRITTEN OFF ARTICLES 7 1

FORMATS TO BE USED 7 3 - 81

32

STORAGE AND STOCK MANAGEMENT The expiry periods of pharmaceutical products have meaning only if the products are stored under proper conditions otherwise products are likely to lose their potency before the actual date of expiry

A pharmacist is a vital link in the distribution chain for pharmaceutical products The medicinal products remain for a long period during the distribution cycle at the wholesaler and at retail pharmacies It is therefore very important to maintain proper storage conditions in these units

Every community pharmacy however large or s mall needs to store and manage its medicine stocks effectively There must be systems to ensure

middot bullbull Secure storage middot bullbull Clean and correct environmental conditions during storage middot bullbull Accurate and effective record keeping middot bullbull Effective stock rotation and expiry monitoring middot bullbull Effective fire and theft prevention middot bullbull Effective rodent pest control

For easier un derstanding this module has been divided into the following sections

1 Quarantine and checking of stocks 11 Quarantine area 12 Checks to be carried out on new stocks

2 S t o r a g e 21 Need for proper storage 22 Different patterns of storage 23 Different means of storage 24 Temperatureclimatic conditions 25 Special storage of supplies 26 Storage and stability of medicines

3 Stock Control and Expiry Monitoring 31 Stock control 3 2 S t o c k r o t a t i o n a n d e x p i r y m o n i t o r i n g

4 Other aspects of s t o r a g e 41 Design of a storage area 42 Cleaning and maintenance 43 Product recalls 44 Returned goods

33

1 QUARANTINE AND CHECKING OF STOCKS

11 Quarantine Area D r u g S t o r e pharmacies receive stoc k s f r o m su pplie r s a c c or d ing to pur c h a se o r d e r s T he stock that is received must be visually checked for quality and quantity The stocks must be kept in a separate area until the checking is done to avoid intermixing with existing stock This necessitates the presence of a separate area within the pharmacy w h e r e i n t h e storage and other checking of stocks can be performed This area is called the QUARANTINE AREA This area should be marked and identified adequately to distinguish it from other areas

The area may be marked using different means 1 ) A s m a l l board saying Quarantine on a separate table used exclusively if it is in the middle 2) A board on the wall if the table on which the quarantine stock is placed is against the wall

middot Stock received from wholesalers should be immediately transferred t o t h e Quarantine Area

middot In the Quarantine area the stock may be stored on racks shelves or in cupboards to prevent ingress of moisture dirt and other contaminants

middot Regular stocks from the pharmacy should not be left kept in the quarantine area Special care has to be taken in case of refrigerated medicines supplied by the suppliers so tha t the y do not remain in the quarantine area for long periods of time They should be immediately checked on receipt and transferred to areas for refrigerated storage s o a s to maintain the cold chain bull

Advantages of having a separate Quarantine Area middot Avoids cross mixing of newly arrived stock from existing stock till it is checked middot Lays stress on checking the quality of the stock received middot S to ck checking ensures t hat defective andor expired goods do not enter the storage areas

34

bullbull

bullbull

12 Checks to be carried out on new stock

Unpacking and checking stock

Supplies received should be unpacked and checked in the quarantine area Staff doing the checks should be adequatel y trained in what they have to check when stock arrives

Checking should be seen not simply as counting the units received but as a part of the quality assurance system bullThis should include middot Visually inspecting the packaging middot Checking the integrity of containers middot V erifying the completeness and leg ibility of la b e ls ( a ppr o ve d dr u g name strength any special storage instructions and expiry date)

bull

The expiry dat e should be checked to ensure that there is adequate shelf life remaining

Supplies should be individually checked using a checklist 35

Checklists

36

The wholesaler supplying the product should be notified immediately in case of any discrepancies ( and the details should be recorded in a register) and sent in a written format to the supplier It should include middot Missing boxes or cartons middot O p en tampered boxes or cartons middot Missing supplies middot Differences in the actual quantity and the quantity shown on the packing middot Additional medicines that had not been ordered but have been supplied middot D a m a g e d b r o k e n o r p oor quality medicines middot Any other discrepancies

The purchase invoices are an important aspect to be considered The invoiced documents should be signed and filed for reference as per the Drugs and Cosmetics Act and retained for at least 3years

If the wholesaler supplies medicines as an emergency without a bill or against a delivery challan

middot The supplies should be checked for integrity and inspected for damage middot The details of supplies received should be recorded middot The supplier should be asked t o send the bill as early as possible middot When the bill is received it should be checked against the details recorded and anomalies if any should be reported to the supplier

To keep a track of the received stock maintaining a S t o c k R e c o r d C a r d c a n b e very useful The entries in the stock record card can be made while checking the stock received STOCK BIN in the stores should have Stock record card

Maintaining a stock card for every product may not be very practical for a retail pharmacy however it could be maintained for costly medicines Nowadays it is much more practical and easier to maintain records using computers

The pharmacist should ensure that medicines manufacturedmarketed by a company are received only through an authorized distribution network of that company This is important to prevent spurious and counterfeit drugs from entering the pharmacy

37

2 STORAGE 21 The need for proper storage The storage of medicines and other products is an important requirement of Good Pharmacy Pr actice Appropriate storage of medicines is essential -

middot bullTo ensure that the potency is maintained middot bullTo prevent deteriorationspoilagedegradation middot bullTo ensuremaintain physical integrity

To ascertain that the quality and safety is maintained throughout their shelf life Storage requirements need to be considered on 2 aspects

a) Integrity of medicines Medicines should be stored in such a way so as to maintain their integrity and potency middot Maintain the right temperature required middot Protect from excessive humidity middot Keep medicines away from direct sunlight middot Protect from pests and rodents

b) Physical location middot Should be easy to locate middot Accessible middot Orderlysystematically placed

2 2 D i f f e r e n t p a t t e r n s o f s t o r a g e The pharmacist could follow any of the different patterns of storage The pattern of stora ge should be selected in such a way that it facilitates speedy and efficient dispensing of medicines

The pattern of storage could vary with each pharmacy experience usual practiceroutine of staff and the person-in charge and also depending on space av ailable turnover etc (i) The medicines could be stored c o m p a n y w i s e ie the medicines manufactured by one company should be grouped together and kept in one place Within each company shelfshelves the medicines may be placed in alphabetical order for easy and quick placement and removal Also bottles tubes boxes etc may be segregated within that shelf

38

(ii) The medicines may also be stored in a lphabe t ic al o r de r ie they are placed in order from left to right based on their name The first letter of the name is used to g r o u p t h e m e d i c i n e s t o g e t h e r a n d k e e p t h e m i n o n e l o c a t i o n I n s o m e p h a r m a c i e s a l l t h e strip packing are placed in drawers or boxes in alphabetical order each box or drawer containing strips of one particular alphabet This system ensures that the strips always remain e n c l o s e d i n t h e b o x e s d r a w e r s a n d a r e n o t e x p o s e d t o d u s t T h e d i s a d v a n t a g e i s that it might lead to mix -u p o f strips in the same drawer and it may cause a problem incase of similar looking strips in which case a wrong medicine may be dispensed Secondly cut strips lying around in the drawer may lose their identity if the batch n u m b e r andor expiry date is not seen on the cut portion of the strip

39

(iii) The medicines may be stored according to their therapeutic class ( e g a n t i b i o t i c s anti asthmatics or anti hypertensives) ie the medicines are kept together based on their pharmacological or therapeutic action

(iv) The medicines may be stockedsegregated according to dosage forms eg l i q u i d s (bottles) solid oral dosage forms eye drops rotacaps ointments etc all stored on separate shelves

Always Remember I Storage of prescription medicines should preferably be separate from OTC medicines OTC medicines especially those that a r e a d v e r t i s e d m a y b e d i s p l a y e d f o r c l i e n t s t o select or to ask questions about [OTC-O v e r t h e c o u n t e r ] II Storage according to temperatures is a must no matter which pattern of storage is followed Also within a particular storage area segregated storage may be maintained In a refrigerator for example medicines may be stored in trays racks and the freezer according to the temperature required

40

Whatever pattern of storage is selected all the personnel should ensure that middot The stocks are stored in an orderly manner middot The medicines are kept back in the same place from where they were removed middot All medicines are arranged neatly once in a while

middot The personnel should be careful while storing the medicines middot They should not throw the medicines haphazardly 23 Different means of storage

middot Within each temperature and security zone medicines must be stored so that they are easily accessible and protected against damage

middot Basic means of storage include shelves racks and drawers middot To prevent dust from entering the shelvesracks it is ideal to have glass

shutterssliding glass doors This can however be disadvantageous because accessibilityspeed is hampered in removing a product from the shelf because the glassshuttersliding glass has to be

41

opened m o v e d e v e r y t i m e a p r o d u c t h a s t o b e p i c k e d u p U s e o f a i r c o n d i t i o n e r s f o r t h e p h arm acy with a closed door at the e n t r a n c e o r a n a i r c u r t a i n c a n r e d u c e t h e d u s t problem In such cases the shelvesracks may be left o p e n

bull

middot Direct storage of cartons on the floor should be avoided because besides being an unhealthy practice the contents may also be damaged by moisture bull

middot Store medicines preferably in shelves with glass shutters for visibility middot Closed shelves further prevent dust from going in especially in India where most

pharmacies are located along busy roads middot Some medicines have to be refrigerated or stored in a cool or cold place Having a

refrigerator or two (as per the need of the pharmacy) is essential to store suc h medicines at temperatures mentioned on the label bull

42

Refrigeration middot All cold chain equipment should meet required standards middot Improvement in refrigeration technology has provided frost -free refrigerators

Pharmacists should opt for frost-free refrigerators as they are easy to maintain and protect printed packaging materials Conventional refrigerators may cause water falling from trays below the freezer on medicines stored in the refrigerator thus causing soggy labels

middot bull Frost-free refrigerators also provide separate and large compartments for the freezer portion (required for storing medicines needing sub-z e r o t e m p e r a t u r e ) and the main storage area with separate doors so that opening one door does not disturb the storage temperature in the other compartment

Care should be taken to keep the refrigerator on 24 hours a day It should not be switched off after working hours It is advisable to have an inverter connected to the refrigerator so that the refrigerator re mains working even when there is a power outage

middot The refrigerator door should be closed tightly middot The refrigerator door should not be left open for too long middot Space should be left between medicines stored in a refrigerator to allow air to

circulate middot The ref rigerator should be placed about an arms length away from the wall

This will increase air circulation thus not affecting the cooling within the refrigerator

middot Vaccines should not be stored on refrigerator door shelves as they are exposed to warmer temperatures each time the door is opened Vaccines should always be stored on the middle shelves of the refrigerator

middot Refrigerated medicines should not be left out of the refrigerator for more than a few minutes

43

middot Consumable products like juices energy drinks e t c s h o u l d n o t b e s t o r e d a l o n g with medicines in refrigerators If required they may be kept in a separate refrigerator

middot An adequate number of refrigerators should be planned to store the entire stocks requiring refrigerated storage

middot Adequate procedures should be followed for defrosting cleaning and maintenance of refrigerators

middot Icefreeze packs should be kept in the freezer compartment so that they can be used for transporting cold temperature medicines The packs can be given to clients along with the medicines requiring cold temperature storage so that the temperature is maintained till the client reaches home and can then put the medicines in a refrigerator) Freezer packs can also be used to keep medicines temporarily in case there is a power outage or refrigerator breakdown

Activity

Prepare a SOP (Standard operating procedure chart) for cleaning a refrigerator Discuss it with your staff finalize its maintenance once a month through AMC -A n n u a l Maintenance contract CMC - Comprehensive maintenance contract and put it up on the pharmacy refrigerator Put the Purchase Order details name of manufacturer Phone of Service Engineer and a register to login the Machine service and down timeService reports may be maintained properly

Refrigerator monitoring and maintenance

middot bullIt is important to carry out routine monitoring and maintenance of the refrigerators and to organize an effective repair system

middot bullThe temperature in the refrigerator must be monitored and recorded routinely at least once a day

middot Any breakdown must be reco rded including the period during which the medicines were exposed to uncontrolled temperatures Medicines may then be kept or discarded depending on the problem guidelines or the manufacturers advice

middot Cold chain monitor cards and devices in or on packages that change color or otherwise alert staff to potential damage assist in monitoring (These are likely to be introduced in India soon)

middot It is essential to have a contingency plan in place before a refrigerator breaks down An arrangement can be made to move the contents to a private refrigerator elsewhere in the community or to obtain a regular supply of ice packs until the defect is rectified

Put filled water bottles in the bottom half of the refrigerator door in order to provide cooling in the refri g e r a t o r w h e n t h e r e i s a p o w e r o u t a g e T h i s m i g h t t a k e c a r e o f t h e temperature when there is no current for a couple of hours If the power outage is expected to last for several hours special arrangements such as an inverter UPS have to be made to keep the refrigerator constantly running in the absence of electricity middot Defrost the refrigerator in case of excessive ice formation and preferably at regular

intervals Keep a record of the same

44

2 4 T e m p e r a t u r e c l i m a t i c c o n d i t i o n s

i) Temperature control middot The medicines in a pharmacy need to be stored at appropriate temperatures to

maintain their stability middot An air-conditioned environment where temperature can be controlled is

recommended for pharmacies Air conditioning offers the option of setting the t e m p e rature as per requirements

middot bullIt is ideal to have an air conditioner to maintain the temperature below 25 C as most medicines require storage below this temperature Secondly this temperature is pleasing to both the staff and the visiting customers too

middot In the absence of an air conditioner circulating fans may be used middot This need is felt even more in certain parts of India where temperatures soar above 45

C and some areas where it falls to sub zero temperatures In such cases temperature maintenance is essential to prevent deterioration of medicines due to unnecessary exposure to drastic temperature fluctuations

middot This need is felt even more in certain parts of India where temperatures soar above 45 C and some areas where it falls to sub zero temperat u r e s I n s u c h c a s e s temperature maintenance is essential to prevent deterioration of medicines due to unnecessary exposure to drastic temperature fluctuations

i i ) Humidity or moisture control Moisture or humidity can adversely affect the stability of me dicines such as tablets capsules powders

45

Gelatin capsules become soft and swell on absorption of moisture The drug content of tablets may undergo surface hydrolysis The presence of moisture may encourage the growth of microbes It is therefore essential to control humidity

To reduce the effect of humidity the following suggestions may be followed -middot Open the windows to allow air circulation Use a fan to circulate fresh (outside) air middot In humid climate a dehumidifier is useful for preventing mo i s t u r e d a m a g e ( i n t h e absence of an air conditioner) middot For bulk containers of tabletscapsules do not keep the container open for a long time and replace the lid or closure immediately after taking out the required number of medicines for dispensing middot Do not allow the medicines to touch the floor or the walls The walls may be damp and may cause moisture absorption damaging the product

middot Calibrated thermometers and manometers can be used to detect temperature and humidity in the pharmacy

middot Periodici t y of checking the temperature should be fixed middot The climatic conditions should be recorded and documented middot Temperature charts should be available for ready reference

Documentation is one of the core activities for achieving and maintaining quality It is one of the most essential components of validation Temperatures in various areas

46

including refrigerators should be recorded at a predetermined periodicity usually daily at the hottest time of the day and such documents should be preserved i i i ) Storage conditions A number of storage conditions are mentioned on the labels of medicinal products These conditions have to be properly interpreted and appropriately complied with

According to the Drugs and Cosmetics Rules 1945

1 The term cool place means a place having a temperature between 10 C and 25 C

2 The term cold place means a place having a temperature not exceeding 8 C In case of storage conditions for specific products please refer to Schedule P The Drugs and Cosmetic Rules 1 9 4 5

The Indian Pharmacopoeia specifies the following storage conditions -

Wherever the condition for storage is not specified medicines may be stored under normal temperature In a country like India however where normal temperatures soar to h i gh temperatures it is recommended that medicines be stored in a cool place

Activity Prepare a list of the storage requirements mentioned on the label of about 20 products in your pharmacy and check if the temperature is maintained

47

25 Special Storage o f s u p p l i e s If the product has no special instructions normal storage conditions apply This means storage in dry clean w e l l -ventilated premises at temperatures of +15 C to +25 C or depending on the climate up to +30 C (WHO1990) Storage instructions are product specific Different brands of the same generic drug may have different storage requirements as they may have different packaging or formulations It is essential to follow the product manufacturers storage instructions to the maximum extent possible Less stable medicines must be stored in specific conditions to maintain their quality or potency

The following products require special storage facilities

middot Products that must be kept frozen (usually vaccines and sera) middot Products sensitive to h eat an d r e q uir in g r e f r ig e r a tio n ( +2 C to +8 C) middot Products that have reduced shelf life at uncontrolled room temperature and need

mechanical ventilation or air conditioning middot Flammable products that require separate fireproof premises middot Products prone to theft o r m i s u s e

Products needing storage in a controlled environment -

The usable shelf life of the following products may be reduced if stored at uncontrolled humidity or at room temperature in hot climates -

middot Some injectables (eg adrenaline) Most injectable preparations are less stable than solid oral forms (tablets and capsules) Injectable preparations in solution are particularly unstable Many injections must be protected from light as well as heat

middot Intravenous fluids (particularly if packed in p lastic containers) middot Some suppositories pessaries creams and ointments These products may melt at

temperatures greater than 30 C Once this happens it is not advisable to use them because the active ingredient in the formula may get unevenly distributed

middot Products containing rubber latex cellulose or some plastics Condoms most sterile disposable medical devices and surgical products such as syringes needles and catheters require protection from excessive humidity and strong light and heat Any o f these conditions may make products brittle stained amp unusable Sterility cannot be assumed if packaging is damaged

In hot climates these products should be stored in the coolest place possible preferably with air conditioning or air circulation fans

48

Products needing freezing or refrigeration-middot Vaccines blood products and many other medicines lose potency if kept even for a

brief period at temperatures outside the recommended range For these products the cold chain must be maintained at every stage of the distribution system

middot Freezing is as damaging as high temperatures for some products including injectable contraceptives ergometrine insulin adrenaline and the DPT DT TT and Hepatitis B vaccines Such products therefore sho uld not be allowed to freeze (not be kept in the freezer compartment)

middot Short periods at room temperature (during transportation or local distribution for instance) may be acceptable for many products (such as ergometrine a n d i n s u l i n ) e v e n t h o u g h s u c h e x posure can to some extent reduce shelf life Other items such as vaccines should always be transported in cold boxes

Storage of insulin injections-

middot Insulin should always be stored in a refrigerator at the recommended temperature of 2 -8 C

middot Insulin should not be kept in the freezer compartment of the refrigerator middot Insulin should ideally be stored horizontally middot It should not be exposed to sunlight or excessive heat middot Insulin suspensions should not be used if the suspension cannot be properly

resuspended due to cake or clump formationbull

Controlled drugs -Narcotics (for example Pethidine injection morphine preparations) and other specified drugs that may be abused are governed by special legislation and regulations The following security measures are suggested in the pharmacy -middot A safe or reinforced double locked cabinet fitted with a light (preferably with a red

bulb) that comes on when the door is opened

49

middot A special register recording details of each receipt or issue with 2 signatures physi cal counting of medicines after each entry and signatures at handover takeover

middot Independent audit (by supervisors and drug inspectors)

Products prone to theft abuse or misuse -

Some medicinesproducts are particularly prone to theft abuse or misuse These include expensive medicines (eg insulin) certain antibiotics and products prone to abuse or misuse like psychotropics etc

Such medicinesproducts should be stored adequately They require stricter record keeping and more frequent stock taki ng than others Periodic audits should be carried out to check for consumption against actual recorded use (registers prescription records stock records etc) to expose any theft or misuse bull26 Storage and stability of medicines Medicines are not stab le indefinitely They are stable for a specific period of time sometimes for a brief period Poor storage conditions accelerate the drug degradation (decomposition) Temperature light and moisture are the most important contributing factors for drug instability It is important to identify and be aware of the potential for instability There is a need to comply with storage requirements to ensure quality medicines for patients It is also important to offer advice to patients too about appropriate storage o f medicines at home The dispensing label should state the storage condition required and be backed up by a verbal reminder especially where special storage is required bull

50

In case stability and storage problems are seen with formulations they should be reported immediately to the representative of the manufacturer and taken out of circulation till the stability problems have been resolved

The pharmacist can easily detect stability problems when products show change in appearance color odor settling of the product contents breaking of emulsions melting of creams oozing of contents from the containers and any such physical changes

3 STOCK CONTROL AND EXPIRY MONITORING 3 1 S t o c k C o n t r o l For economic reasons pharmacists do not like to have stock on their shelves for long periods of time The aim should always be to keep stock at a level that will just meet demand Normally most manufactured medicines have a long shelf life Even then it is essential that there is efficient stock rot ation so that the older stock is used first It is also a good practice to check the expiry date as an integral part of the dispensing process When short shelf life products are involved stock levels may have to be modified to prevent medicines regularl y expiring on the shelves

32 Stock rotation and expiry monitoring In order to avoid accumulation of expired and obsolete stock medicines should be stored and issued according to the following guidelines -middot The stock control system must record the ex p i r y d a t e a n d t h e d a t e o f r e c e i p t middot Stock must be stored so that earliest expiring batches are picked and issued first middot The First In First Out (FIFO) system - In this system the stock which is received

first is sold first This system however may not be useful for pharmacies because most of the stocks carry an expiry date For pharmacies the FEFO system is more practical

51

middot The First Expiry First Out (FEFO) system - In this system the stock having an earlier expiry is sold first The stock with longer shelf life should be placed farthest to the back (or at the bottom in case o f sta c k e d b oxe s) T h is is pa r tic u la r ly impor ta n t with products that have short shelf lives such as vaccines some vitamins antibiotics etc and reduces losses due to expiry

middot E x p i r y dates should be noted on the stock record upon receipt Stock nearing expiry should not be accepted unless it can be used before expiry

Computerization and expiry monitoring In the pharmacy computerization facilitates both checking stocks and expiry mo nitoring and helps-bullbullKeeping a check on products nearing expiry bullbullKeeping a check on non- moving and slow moving products bullbullTo facilitate the removal of medicines nearing expiry from shelves in time to send them back to the wholesaler or supplier

Periodic checking for expiry The expiry date for medicinal products is a critical aspect in pharmaceutical dispensing and due importance should be given to it Periodic checking for expiry of medicines will ensure that the patient will never receive products that have crossed their expiry date During periodical checking of expiry the personnel involved should remove medicines that are nearing expiry bullbullIn -house threshold periods should be set and followed for retrieval of such medicines from the shelves bullbullSuch medicines should be stored separately These should either be dispensed immediately (thus ensuring that they are used before the expiry date) o r t h e y s h o u l d b e returned to the suppliers bullbullA separate area should be designated (cupboard or shelf)marked[FROZEN ZONE] which is adequately marked EXPIRED GOODS- NOT FOR SALE to store all expired stocks FROZEN ZONE

52

Remember Expired medicines are a NATIONAL WASTE So stock only what you can sell Avoid expiries save precious medicines for the nation

Treatment and disposing of expired medicines bullbullProcedures need to be in place for the treatment of expired medicines bullbullThe expired medicines need to be collected and be sent back to the supplier or company for appropriate disposal bullbullRecords must be maintained for expired medicines and how they are disposed off bullbullIn case of medicines that are not returnable to suppliers procedures for disposal need to be followed by the pharmacy in conjunction with the FDA The following procedure can be followed if medicines cannot be returned to suppliers ( T h e b a s i c p h i l o s o p h y of appropriate disposal is to prevent their re- circulation and use) bullbullC u t t h e c o n t ainer in such a manner that the label is also cut In case of tablets and c a p s u l e s d e s t r o y them by disposing them in a bucket of water bullbullUse landfill procedures (deep burial into the ground as per stipulations of Medical Waste Disposal Act prevalent in the respective state) bullbullPour the liquids into the sink and wash away with sufficient quantity of water bullbullKeep a record of such disposal with full details of medicines destroyed Although these measures are usually adopted care has to be taken with such tr e a t m e n t a s studies have shown that flushing of medicines has resulted in tracessmall quantities of medicines being found in waterways and groundwater having potential health and environmental effects

4 O T H E R A S P E C T S 41 Design of storage areas The following important factors need to be considered in design of storage areas -middot The retail outlets in hot areas in summers should be air-conditioned Similarly in

a r e a s o f e x t r e m e c o l d t h e p r e m i s e s w o u l d r e q u i r e w a r m i n g e s p e c i a l l y i n w i n t e r s t o maintain cool temperatures The placement of air -conditioners and heating devices should be such that medicines are not directly exposed to the cold or heat

middot Due consideration should be given to storage requirements of formulations while designing shelves and cupboards in retail outlets Sufficient shelf height should be provided so that all liquid products can be stored vertically As far as possible the shelves should be covered with glass panels to protect medicines from dust and p r e v e n t r a p i d f l u c t u a t i o n s i n temperature

middot Medicines should be stored according to the storage instructions on the labels bullIt is ideal to have a door at the pharmacy entrance to prevent dust from coming in as well as reduceprevent cooled air from going out This may not however be considered feasiblepracticable by many pharmacy owners for fear that clients may not enter the pharmacy because the door may act as a barrier An air curtain is a good alternative to a door

middot There should be minimal direct sunlight falling on the products Particular consideration should be given to premises directly facing the sun

middot bullThe arrangement of lighting in the interior of the premises should also be in a manner that the lights are not focused on the products It has been shown that light causes not only chemical damage but also can catalyze physical changes like moisture uptak e by the products Care should be taken to ensure that only diffused light falls on them

53

middot As far as possible provision should be made for a temperature and humidity indicator device in a pharmacy These devices are now easily available

middot Stability studies o f m e d i c i n e s p a c k e d i n b l i s t e r s h a v e r e v e a l e d t h a t i f t h e s e a r e exposed to light they tend to absorb moisture It is therefore necessary to store them in suitable cartons so that the blisters are not exposed to light Pharmacists should do this even if the manufacturer has not provided cartons

middot Light and temperature sensitive products should not be stored on counters where the light is intense or direct and there is no protection from temperature and humidity

42 Cleaning and maintenance i) Cleaning of storage areas

The storage areas of the pharmacy should be cleaned periodically and cleanliness should be maintained at all times The Standard Operating Procedure for cleaning should be designed and followed accordingly Schedules for cleanups should be laid down and adequate cleaning equipment should be made available

Tips for maintaining cleanliness middot Provide clean pieces of cloth for wiping at various locations in the pharmacy

Replace with clean cloth at regular intervals middot Keep separate pieces of cloth for floors shelves and medicines middot Use a disinfectant andor soap solution to clean floors middot Ensure removal of dust and prevent accumulation of dirt middot Ensure removal of cobwebs middot Use a vacuum cleaner for cleaning areas not easily reachable middot T a k e c a r e t h at breakages are handled and cleared effectively middot Observe the factors leading to waste generation in the pharmacy and take appropriate

measures to tackle the problem middot Record all cleaning procedures performed and maintain all the documents required

For ex a m p l e -bullbullThe floor of the pharmacy may be swept with a broom and swabbed with soap water every morning bullbullThe floor may be swabbed with a disinfectant every week bullbullThe entire premises including shelves and cupboards may be cleaned with a cloth (to remove dust and to check for medicines approaching expiry date or expired medicines) every three months bullbullAll the steps followed should be r e c o r d e d

The floor shelves drawers have to be cleaned and a check should be kept on dust cobwebs spillages due to breakage etc It is therefore essential to have SOPs for cleaning laying down cleaning frequencies allotting responsibilities and maintaining a daily record in the logbook to document all these activities

54

While cleaning dust settled on dosage forms like bottles tubes etc should be removed Before dispensing the products should also be wiped to remove any dust settled during storage

For refrigerators bullbullDefrosting and cleaning should be done at regular intervals bullbullSwitch off the refrigerator while cleaning bullbullCleaning should be done quickly and stocks put back immediately

i i ) Pest control Pests are a serious problem in India where insects reptiles and rodents (eg cockroaches l i z a r d s r a t s s i l v e r f i s h (Deemak - in Hindi ) etc) may find access to the pharmacy storage areas Insects like ants and borer ants may often attack wood in the pharmacy causing d am ag e to shelves cupboardsPest c ontr o l in a p h a r m a c y c a n b e a d i f f i c u l t t a s k b u t t o avoid possible contamination and physical damage to stock it is necessary to keep pests out of the pharmacy premisesPest control measures should be implemented with proper p r e c a u t i o n s t a k i n g u t m o s t c a r e t o a v o i d contamination of medicines

55

Th e following pest control measures c a n be ta ke n f r om tim e to tim e -bullbullRat bait and traps can be placed at various locations bullbullInsecticutors can be used on a permanent basis bullbullInsecticidal sprays and repellants can be used from time to time

i i i ) Fire precautions

Combustible trash such as cartons boxes and other packing waste must not be allowed to accumulate in the store Waste should be deposited in appropriate waste bins and be d i s p o s e d o f f o n a d a i l y b a s i s

F i re detection and fire fighting equipment must be maintained and regularly inspected The pharmacy personnel should receive adequate training in fire fighting techniques and emergency actionFire prevention measures should include a prominently displayed ldquoNoSmokingrdquo sign careful handling and disposal of combustible waste materials and checking of electrical connections at regular intervals

iv) Security middot Doors shutters of the pharmacy should be strong and be fitted with secure locks middot Counters should be designed so that unauthorized personnelclients do not have

access to areas where prescription medicines are stored Access to such areas should be restricted to the pharmacy staff

middot All the pharmacy staff handling supplies should be accountable for their ac t i o n s

56

middot bullSpecial care must be taken in case of Schedule X and manufactured drugs (under NDPS Act) Such medicines should be kept under lock and key and the key should be kept with the Chief Pharmacist or i n h i s a b s e n c e t h e s e n i o r p h a r m a c i s t

v) Breakagespillage and damaged product Products that have been damagedspoiled during storage and handling spillages and broken glassware should be disposed off according to procedures laid down by the pharmacy Broken and damaged products s h o u l d b e p l a c e d i n a segregated area to be returned to the supplier

vi) Inspection Senior staff should inspect all pharmacy areas regularly The shelves and drawers should b e c h e c k e d d a i l y f o r signs of pests and dust Ceiling and walls should be checked for dirt and cobwebs Stock should be checked on a regular basis for deterioration due to climatic conditions

43 Product recalls Products found to be defective should be quickly recalled (withdrawn from the market) The instructions are generally issued either by the manufacturer or the regulatory agency The level of recall is determined by both the degree of risk and the extent of distribution of the product and in India is mainly directed at the distribution chain

On receiving the details of the defective substandard spurious batchbatches of a medicine to be recalled from the manufacturer or the stockist or the FDA the pharmacy should immediately check if the particular b a t c h i s i n s t o c k a n d i f s o s u s p e n d i t s s a l e immediately

Similarly if the regulatory authority in the country bans a particular medicine or FDC the pharmacy should immediately check and remove all the different brands of that particular medicine under consideration

The details of medicines and their batches to be recalled should be available in the q u a r a n t i n e a r e a w h e r e stocks are received and checked This is to ensure that such medicines do not come into the pharmacy

middot The pharmacy should develop SOPs for recall of medicines middot The pharmacy staff should be immediately informed about such medicines and

the details should be displayed in writing in a prominent place in the pharmacy middot Rapid action helps avoid unnecessary exposure to such medicines once the

problem has been d e t e c t e d middot The progress of the recall procedure in the pharmacy should be monitored every

few days to ensure complete compliance middot All stocks of the recalled products should be stored separately from the saleable

stock These can be stored in the expiry cupboard segregated from the expired goods and be appropriately labeled ldquoRecal l e d G o o d s - Not for Salerdquo

The supplier should be notified and asked to replace defective products middot All the details of the procedures followed should be duly recorded in a Recall

Register maintained specially for the purpose The register should include d etails such as -middot Date of the recall middot Nam e of the product

57

bullbull

middot Details of the product (name of manufacturer batch number expiry date) middot Nu m b er of units purchased sold a n d sto c k in ha nd middot Reason for recall middot Nam e of the supplier to whom produc ts w e r e returned along with the date and quantity middot Name and signature of the designated personnel carrying out the recall procedure and recording details middot Name and signature of the chief pharmacist verifying the recall procedures and recording details 4 4 Returned medicines

Medicines may be returned to the pharmacy by clients due to the following reasons -bull

bullbull Unused medicines bullbull Course not completed bullbull Therapy changed by doctor bullbull Side effects experienced by patient bull

bullbull DamagedDefective medicines bullbull Missing or defaced label bullbull Missing tablets in a stripblister bullbull Leakage in bottles bullbull Leakage in strips bull

bullbull Expired medicines

Appropriate SOPs should be framed and followed for their acceptancerefusal and disposal middot bull For unused medicines returned by clients the p harmacy personnel should verify

that these were purchased from their pharmacy They should then be checked for integrity of the packing the dosage form and the expiry date and verified with the client whether they were stored in appropriate conditions This again is at the discretion of each pharmacy

middot The damageddefective medicines returned to the pharmacy should be taken back and stored separately Existing stock of the same product should be checked for similar defects

middot Expired medicines should be accepted from clients at the discretion of the pharmacist and be immediately shifted to the expired goods cupboard These can be stored segregated from the pharmacys own expired goods and be appropriately labelled ldquoExpired Goods returned by clients- Not For Salerdquo

It is advisable not to accept returned medicines requiring cold chain storage (refrigeration) because it cannot be ensured that the cold chain was maintained when the medicines were in the hands of the patientclient middot Appropriate adjustments in t he stocks should be made for medicines

returnedexchanged to update the inventory middot The medicines should then be returned to the respective shelves middot A lsquoReturned Goodsrsquo register needs to be maintained to record all details of returned

medicines

R egister should include such details as-

58

middot N a m e o f t h e p a t i e n t middot Nam e of the product and quantity r e tu r n e d middot Product details such as the batch number and expiry date middot Condition in which received middot Reason for returning products middot Compensatory measures taken wi t h r e s p e c t t o c l i e n t middot Action taken with respect to product middot Name and signature of the personnel accepting the returned medicines and recording details middot Name and signature of the chief pharmacist verifying the recorded details

What the pharmacist would have learnt from this module The storage of medicines is a critical factor in the distribution cycle bullbull Stocks received by the pharmacy should be quarantined in a separate area and necessary checks s h o u ld be performed to ascertain the qua lity a nd quantity of stocks received bullbull Whatever pattern and means of storage used the products should be stored so as to maintain their potency and integrity bullbull Storage conditions should be monitored and maintained on a regular basis bullbull Optimum stock levels should be maintained and regularly monitored for expiry bullbull The design of storage areas should facilitate appropriate storage of medicines bullbull Cleanliness should be maintained in the pharmacy bullbull Adequate measures should be taken in case of returned medicines and recalled products

Optimum storage of medicines is mandatory whether at the distribution stage at the pharmacy or ultimately within the homes of patients The pharmacist has an important r o l e t o p l a y i n t h e s t o r a g e o f m e d i c i n e s i n m a i n t a i n i n g d r u g p o t ency and efficacy and thus facilitating optimum therapeutic benefits Good Pharmacy Practice - IPA -CDSCO - WHO Appendix I Quality Assurance Templates of letters for use if found not of Standard Quality [Frozen and expired goods ]

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated To Name of the Supplier with address

Sub Not of Standard Quality GoMP-Supply of Drugs and medicines-(Codename) Return of Stocks to the Suppliers-reg(New drug policy 2009) Previous letterinvoice ref Sl No Drug Code Drug name

Manufacturing date Expiry date

Supplier address

B a t c h n o

The above items of PO nodated was drawn by the Drug Inspector (Place) on (______________date) as a statutory sampling and declared ldquoNot of Standard

59

Qualityrdquo on -(______________date) by the Government Analyst for the following reasons

- ldquoThe product sample do not confirm to IP specification for (Drug codename with respect to the content of drugrdquo

- ldquoThe product has already been blacklisted by TNMSC on -(______________date) for the failure of (quantity) of batches of drug codenamerdquo

As per the clause of the te nde r d oc um e nt ldquo I f the sa mple s d o not c onf o r m to statutory standardsthe tenderer will be liable for relevant action under the existing laws and the entire stock in such batch should be taken back by the tenderer within a period of 30 days o f t h e r e c e i p t o f t h e l e t t e r f r o m t h e v e n u e

The stock shall be taken back at the expenses of the tendererthe Procurement Authority have the right to destroy such Not of Standard Quality if the tenderer does not take back the goods within the stipulated time

The Procuring Authority will arrange to destroy the Not of Standard Quality drugs within 90 days after the expiry of 30 days mentioned above without further notice and shall also collect demurrage charges calculated at the rate of 2 per week on the value of the drugs rejected till such destructionrdquo

Hence we regret to inform you that you will have to take back the stocks available of the abovesaid batch at your own cost from the drug stores where you have supplied the above batch

Kindly acknowledge the receipt of this reference at once

P r o c u r e m e n t A u t h o r i t y Seal and Stamp

Copy to Ref No dated

1 ) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated13082010

To

Sub Frozen Drugs-ordered to return to the Suppliers-reg(New drug policy 2009) Previous letterinvoice ref

The following products which were earlier frozen have now been ordered to return to suppliers directly with permission from the State drug Authority In this regard the suppliers have been instructed to take back their failed batch from the drug store of the stores Hence you are now instructed to return the following failed batches to the suppliers by obtaining proper authorization letter and acknowledgements from them

60

Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

Kindly acknowledge the receipt of this reference at once

Procurement Authority Seal and Stamp

Copy to

Ref No dated 2) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated14092010

To

Sub Frozen Drugs-ordered to return to the Suppliers- for issue of gate pass after verification reg(New drug policy 2009) Previous letterinvoice ref

The following products which were earlier frozen have now been released Hence they may be issued Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

Kindly acknowledge the receipt of this reference at once

Procurement Authority Seal and Stamp

Copy to

61

Ref No dated 3) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated

To

Sub Stop instruction-reg(New drug policy 2009) Previous letterinvoice ref

Until further instructions stop issue all the batches of the following item Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

You must intimate the available stock in the stores of the said batch Number to the Procurement Authority immediately Also retrieve quantity if already issued

Procurement Authority Seal and Stamp

Copy to

Ref No dated 4) HOD Procurement Office of

62

Appendix II Material handling in drug stores

Rack approx rates and dimensions

S No

Item Description UOM Approx Rate

1 MEDIUM DUTY RACK SIZE 2900 H X 3090 W X 800 D IN MM (AS PER SPECIFICATION)

Each 2499800

2 MEDIUM DUTY RACK ADD ON UNIT FOR SIZE OF SR NO2

Each 2243100

To locate a Box no 3 Rack no 14 in row3

SAMPLE OF RACK no Bin numbering -------------- S a y R K 1 4 R o w 3 B o x 1 6

SAMPLE LAYOUT of RACKS in a Drug Stores

63

Sample of another warehouse of distribution warehouse system

64

65

Slotted Angle racks with bin cards

66

Plastic Pallets

Plastic pallets ar e l i g h t w e i g h t l o w- c ost and exceed industry standards for strength and durability

NOTE A pallet has bottom deckboards (see sketch) A skid does not have bottom

67

deckboards

Battery Operated Stacker

Electric Stacker Ehh (Manual Push Type) - Manual drive - Lifting electrically with Battery 12 V 88 Ah - For loading and un-loading of trucks - Battery and loading device built - in - Battery charge gauge and charging current gauge Simple and Easy Operation - Lifting and Lowering electrically direct on steering arm - Pulling and pushing through steering arm - Electrically operated relief valve on hydraulic aggregate Safe Operation - Emergency Off Switch - Constant lowering speed - Protection through lowering brake valve - Overload protection through overload brake valve - Load chains covered preventing pinching threat - Electrically interlocking during loading process - Secured battery compartment opens upwardly - Stable buffering of the steering arm in upright position - In accordance with EWG Guidelines 89 240 - In accordance with VBG 12b Prevention of Accidents

Pallet Truck [ Top ]

68

----------------------------------------------------------------------------------------------------------------------------

For Transport Of All Goods On Pallets Safe and Easy Operation - through single hand operation Lifting moving

lowering with steering handle - neutral position of the hydraulic possible - overload pressure relief valve Long Service Life - robust co n s t r u c t i o n

- special hardened axles - hardened chromium plated ram - maintenance free Easy Maneuverability - through rubber steering rollers - nylon fork rollers

A h a n d t r o l l e y

69

Trolley with plastic bins for several items del ivery

70

Digital Weighing balances

Balances amp Scales EF Seriers Precision Electronic Balance

71

1

Ice lined Refrigerators

600 litres refrigrator

72

Walk in cooler

vacuum cleaner

73

Annexure-G

TREATMENT CARD

WARD NO

NAME OF PATIENT BED NO DATE amp TIME OF ADMISSION DATE amp TIME OF DISCHARGE

DATE MEDICINES PRESCRIBED SIGNATURE

26

ANNEXURE -H

PROFORMA FOR BREAKAGE amp LOSS

NAME OF OFFICEINSTITUTION DATE PLACE

SRNO NAME amp

DESCRIPTION OF ARTICLE

COST DATE OF PURCHASE

REASON CAUSE OF BREAKAGE

RECOMMENDATION OF INVESTIGATING AUTHORITY

Signature

Orders of the Competent Authority

Signature

27

Annexure ndash I Loss- Procedure for Reporting

1 The exact nature of the defalcation 2 The full extent of loss 3 The actual period covered by the defalcation 4 The defects in the negle c t o f r u le s by w hic h the loss was rendered possible

and circumstances which facilitated the defalcation 5 The names of the officials held personally or technically directly or

indirectly and wholly or partially responsible for the irregularity c o m m i t t e d i n t h e c a s e

6 Whether the c a s e a s b e e n J u d i c i a l l y t r i e d i n a c o u r t o r n o t i f s o c o p i e s ( i n duplicate) of the Judgment may please be furnished Copy of police report may also be furnished

7 The remedial measures adopted as safeguards against the losses hereafter 8 The prospects of re covery of the loss and he action taken to effect

recovery together with the amount recovered 9 Head of Account to which the Loss is debitable may be informed

Signature of Head of Office with seal

NoteA copy of this report is to be sent to AGMPThis is as per M P Finance Code Vol I

28

STORAGE AND STOCK MANAGEMENT

29

Foreword

The New Drug Policy 2009 is being implemented in the State of Madhya Pradesh

In order to have a proper procedure for Storage maintenance and expiry management of the drugs it is necessary to follow Good Storage Practices with Standard Modules for pharmacistStore keepers

Proper guidelines on Storage Practices can lead to better Stores and inventory upkeep with medicines being properly stored in racks with proper cleanliness and hygiene

This is a step towards storage maintenance and expiry management at the various stores in the state Looking forward to see that the heads of all health facilities take benefit from this module

D ir e c t o r M e d i c a l S e r v i c e s

30

INDEX

Sr No P a r t i c u l a r s P a g e

1 S T O R A G E A N D S T O C K M A N A G E M E N T 4

1 Quarantine and checking of stocks 11 Quarantine area 12 Checks to be carried out on new stocks

2 S t o r a g e 21 Need for proper storage 22 Different patterns of storage 23 Different means of storage 24 Temperatureclimatic conditions 25 Special storage of supplies 26 Storage and stability of medicines

3 Stock Control and Expiry Monitoring 31 Stock control 32 Stock rotation and expi r y m o n i t o r i n g

4 Other aspects of storage 41 Design of a storage area 42 Cleaning and maintenance 43 Product recalls 44 Returned goods

2 A p p e n d i x 1 Templates of letters for use if found not of Standard Quality [Frozen and expired goods ]

Frozen Drugs-ordered to return to the Suppliers-reg(New drug policy 2009)

Frozen Drugs-ordered to return to the Suppliers- for issue of gate pass after verification reg(New drug policy 2009) Stop instruction-reg(New drug policy

2009) Appendix II Material handling in drug stores

31

3 PROCUREMENT ndash Government Order Relating to

the Management of Stores

(Reproduced for reference material on basic

procedure in decentralized system followed by

Health facilities in 1977)

54

F L O W C H A R T S f o r a BI R D S E Y E V I E W o f

P R O C U R E M E N T

5 5

ACQUISITION OF STORES 6 1

PLACING OF ORDERS 6 2

RECEIPT OF STORES 6 2

CUSTODY 6 3

ISSUE OF STORES Maintenance of Stock Books

6 3

PROCEDURE OF INDENTING FOR WARD amp OTHER SECTIONS OF THE INSTITUTION

6 4

HOW OFTEN TO INDENT 6 5

EMERGENT INDENT 6 5

HOW TO INDENT 6 5

KEEPING OF RECORDS IN WARDS A N D S E C T I O N S

6 6

ACCOUNTABILITY OF DRUGS BROUGHT BY THE PATIENT OR RECEIVED IN DON A T I O N BY T H E WARDSECTION _IN - CHARGE

6 7

RESPONSIBILITY OF STORES AT VARIOUS LEVELS

6 7

DISTRIBUTION OF MEDICINES FROM OUTDOOR DEPARTMENT

6 7

LOSS BREAKAGE DAMAGE ETC 6 8

PROCEDURE FOR WRITING OFF STORES 6 9

DISPOSAL OF WRITTEN OFF ARTICLES 7 1

FORMATS TO BE USED 7 3 - 81

32

STORAGE AND STOCK MANAGEMENT The expiry periods of pharmaceutical products have meaning only if the products are stored under proper conditions otherwise products are likely to lose their potency before the actual date of expiry

A pharmacist is a vital link in the distribution chain for pharmaceutical products The medicinal products remain for a long period during the distribution cycle at the wholesaler and at retail pharmacies It is therefore very important to maintain proper storage conditions in these units

Every community pharmacy however large or s mall needs to store and manage its medicine stocks effectively There must be systems to ensure

middot bullbull Secure storage middot bullbull Clean and correct environmental conditions during storage middot bullbull Accurate and effective record keeping middot bullbull Effective stock rotation and expiry monitoring middot bullbull Effective fire and theft prevention middot bullbull Effective rodent pest control

For easier un derstanding this module has been divided into the following sections

1 Quarantine and checking of stocks 11 Quarantine area 12 Checks to be carried out on new stocks

2 S t o r a g e 21 Need for proper storage 22 Different patterns of storage 23 Different means of storage 24 Temperatureclimatic conditions 25 Special storage of supplies 26 Storage and stability of medicines

3 Stock Control and Expiry Monitoring 31 Stock control 3 2 S t o c k r o t a t i o n a n d e x p i r y m o n i t o r i n g

4 Other aspects of s t o r a g e 41 Design of a storage area 42 Cleaning and maintenance 43 Product recalls 44 Returned goods

33

1 QUARANTINE AND CHECKING OF STOCKS

11 Quarantine Area D r u g S t o r e pharmacies receive stoc k s f r o m su pplie r s a c c or d ing to pur c h a se o r d e r s T he stock that is received must be visually checked for quality and quantity The stocks must be kept in a separate area until the checking is done to avoid intermixing with existing stock This necessitates the presence of a separate area within the pharmacy w h e r e i n t h e storage and other checking of stocks can be performed This area is called the QUARANTINE AREA This area should be marked and identified adequately to distinguish it from other areas

The area may be marked using different means 1 ) A s m a l l board saying Quarantine on a separate table used exclusively if it is in the middle 2) A board on the wall if the table on which the quarantine stock is placed is against the wall

middot Stock received from wholesalers should be immediately transferred t o t h e Quarantine Area

middot In the Quarantine area the stock may be stored on racks shelves or in cupboards to prevent ingress of moisture dirt and other contaminants

middot Regular stocks from the pharmacy should not be left kept in the quarantine area Special care has to be taken in case of refrigerated medicines supplied by the suppliers so tha t the y do not remain in the quarantine area for long periods of time They should be immediately checked on receipt and transferred to areas for refrigerated storage s o a s to maintain the cold chain bull

Advantages of having a separate Quarantine Area middot Avoids cross mixing of newly arrived stock from existing stock till it is checked middot Lays stress on checking the quality of the stock received middot S to ck checking ensures t hat defective andor expired goods do not enter the storage areas

34

bullbull

bullbull

12 Checks to be carried out on new stock

Unpacking and checking stock

Supplies received should be unpacked and checked in the quarantine area Staff doing the checks should be adequatel y trained in what they have to check when stock arrives

Checking should be seen not simply as counting the units received but as a part of the quality assurance system bullThis should include middot Visually inspecting the packaging middot Checking the integrity of containers middot V erifying the completeness and leg ibility of la b e ls ( a ppr o ve d dr u g name strength any special storage instructions and expiry date)

bull

The expiry dat e should be checked to ensure that there is adequate shelf life remaining

Supplies should be individually checked using a checklist 35

Checklists

36

The wholesaler supplying the product should be notified immediately in case of any discrepancies ( and the details should be recorded in a register) and sent in a written format to the supplier It should include middot Missing boxes or cartons middot O p en tampered boxes or cartons middot Missing supplies middot Differences in the actual quantity and the quantity shown on the packing middot Additional medicines that had not been ordered but have been supplied middot D a m a g e d b r o k e n o r p oor quality medicines middot Any other discrepancies

The purchase invoices are an important aspect to be considered The invoiced documents should be signed and filed for reference as per the Drugs and Cosmetics Act and retained for at least 3years

If the wholesaler supplies medicines as an emergency without a bill or against a delivery challan

middot The supplies should be checked for integrity and inspected for damage middot The details of supplies received should be recorded middot The supplier should be asked t o send the bill as early as possible middot When the bill is received it should be checked against the details recorded and anomalies if any should be reported to the supplier

To keep a track of the received stock maintaining a S t o c k R e c o r d C a r d c a n b e very useful The entries in the stock record card can be made while checking the stock received STOCK BIN in the stores should have Stock record card

Maintaining a stock card for every product may not be very practical for a retail pharmacy however it could be maintained for costly medicines Nowadays it is much more practical and easier to maintain records using computers

The pharmacist should ensure that medicines manufacturedmarketed by a company are received only through an authorized distribution network of that company This is important to prevent spurious and counterfeit drugs from entering the pharmacy

37

2 STORAGE 21 The need for proper storage The storage of medicines and other products is an important requirement of Good Pharmacy Pr actice Appropriate storage of medicines is essential -

middot bullTo ensure that the potency is maintained middot bullTo prevent deteriorationspoilagedegradation middot bullTo ensuremaintain physical integrity

To ascertain that the quality and safety is maintained throughout their shelf life Storage requirements need to be considered on 2 aspects

a) Integrity of medicines Medicines should be stored in such a way so as to maintain their integrity and potency middot Maintain the right temperature required middot Protect from excessive humidity middot Keep medicines away from direct sunlight middot Protect from pests and rodents

b) Physical location middot Should be easy to locate middot Accessible middot Orderlysystematically placed

2 2 D i f f e r e n t p a t t e r n s o f s t o r a g e The pharmacist could follow any of the different patterns of storage The pattern of stora ge should be selected in such a way that it facilitates speedy and efficient dispensing of medicines

The pattern of storage could vary with each pharmacy experience usual practiceroutine of staff and the person-in charge and also depending on space av ailable turnover etc (i) The medicines could be stored c o m p a n y w i s e ie the medicines manufactured by one company should be grouped together and kept in one place Within each company shelfshelves the medicines may be placed in alphabetical order for easy and quick placement and removal Also bottles tubes boxes etc may be segregated within that shelf

38

(ii) The medicines may also be stored in a lphabe t ic al o r de r ie they are placed in order from left to right based on their name The first letter of the name is used to g r o u p t h e m e d i c i n e s t o g e t h e r a n d k e e p t h e m i n o n e l o c a t i o n I n s o m e p h a r m a c i e s a l l t h e strip packing are placed in drawers or boxes in alphabetical order each box or drawer containing strips of one particular alphabet This system ensures that the strips always remain e n c l o s e d i n t h e b o x e s d r a w e r s a n d a r e n o t e x p o s e d t o d u s t T h e d i s a d v a n t a g e i s that it might lead to mix -u p o f strips in the same drawer and it may cause a problem incase of similar looking strips in which case a wrong medicine may be dispensed Secondly cut strips lying around in the drawer may lose their identity if the batch n u m b e r andor expiry date is not seen on the cut portion of the strip

39

(iii) The medicines may be stored according to their therapeutic class ( e g a n t i b i o t i c s anti asthmatics or anti hypertensives) ie the medicines are kept together based on their pharmacological or therapeutic action

(iv) The medicines may be stockedsegregated according to dosage forms eg l i q u i d s (bottles) solid oral dosage forms eye drops rotacaps ointments etc all stored on separate shelves

Always Remember I Storage of prescription medicines should preferably be separate from OTC medicines OTC medicines especially those that a r e a d v e r t i s e d m a y b e d i s p l a y e d f o r c l i e n t s t o select or to ask questions about [OTC-O v e r t h e c o u n t e r ] II Storage according to temperatures is a must no matter which pattern of storage is followed Also within a particular storage area segregated storage may be maintained In a refrigerator for example medicines may be stored in trays racks and the freezer according to the temperature required

40

Whatever pattern of storage is selected all the personnel should ensure that middot The stocks are stored in an orderly manner middot The medicines are kept back in the same place from where they were removed middot All medicines are arranged neatly once in a while

middot The personnel should be careful while storing the medicines middot They should not throw the medicines haphazardly 23 Different means of storage

middot Within each temperature and security zone medicines must be stored so that they are easily accessible and protected against damage

middot Basic means of storage include shelves racks and drawers middot To prevent dust from entering the shelvesracks it is ideal to have glass

shutterssliding glass doors This can however be disadvantageous because accessibilityspeed is hampered in removing a product from the shelf because the glassshuttersliding glass has to be

41

opened m o v e d e v e r y t i m e a p r o d u c t h a s t o b e p i c k e d u p U s e o f a i r c o n d i t i o n e r s f o r t h e p h arm acy with a closed door at the e n t r a n c e o r a n a i r c u r t a i n c a n r e d u c e t h e d u s t problem In such cases the shelvesracks may be left o p e n

bull

middot Direct storage of cartons on the floor should be avoided because besides being an unhealthy practice the contents may also be damaged by moisture bull

middot Store medicines preferably in shelves with glass shutters for visibility middot Closed shelves further prevent dust from going in especially in India where most

pharmacies are located along busy roads middot Some medicines have to be refrigerated or stored in a cool or cold place Having a

refrigerator or two (as per the need of the pharmacy) is essential to store suc h medicines at temperatures mentioned on the label bull

42

Refrigeration middot All cold chain equipment should meet required standards middot Improvement in refrigeration technology has provided frost -free refrigerators

Pharmacists should opt for frost-free refrigerators as they are easy to maintain and protect printed packaging materials Conventional refrigerators may cause water falling from trays below the freezer on medicines stored in the refrigerator thus causing soggy labels

middot bull Frost-free refrigerators also provide separate and large compartments for the freezer portion (required for storing medicines needing sub-z e r o t e m p e r a t u r e ) and the main storage area with separate doors so that opening one door does not disturb the storage temperature in the other compartment

Care should be taken to keep the refrigerator on 24 hours a day It should not be switched off after working hours It is advisable to have an inverter connected to the refrigerator so that the refrigerator re mains working even when there is a power outage

middot The refrigerator door should be closed tightly middot The refrigerator door should not be left open for too long middot Space should be left between medicines stored in a refrigerator to allow air to

circulate middot The ref rigerator should be placed about an arms length away from the wall

This will increase air circulation thus not affecting the cooling within the refrigerator

middot Vaccines should not be stored on refrigerator door shelves as they are exposed to warmer temperatures each time the door is opened Vaccines should always be stored on the middle shelves of the refrigerator

middot Refrigerated medicines should not be left out of the refrigerator for more than a few minutes

43

middot Consumable products like juices energy drinks e t c s h o u l d n o t b e s t o r e d a l o n g with medicines in refrigerators If required they may be kept in a separate refrigerator

middot An adequate number of refrigerators should be planned to store the entire stocks requiring refrigerated storage

middot Adequate procedures should be followed for defrosting cleaning and maintenance of refrigerators

middot Icefreeze packs should be kept in the freezer compartment so that they can be used for transporting cold temperature medicines The packs can be given to clients along with the medicines requiring cold temperature storage so that the temperature is maintained till the client reaches home and can then put the medicines in a refrigerator) Freezer packs can also be used to keep medicines temporarily in case there is a power outage or refrigerator breakdown

Activity

Prepare a SOP (Standard operating procedure chart) for cleaning a refrigerator Discuss it with your staff finalize its maintenance once a month through AMC -A n n u a l Maintenance contract CMC - Comprehensive maintenance contract and put it up on the pharmacy refrigerator Put the Purchase Order details name of manufacturer Phone of Service Engineer and a register to login the Machine service and down timeService reports may be maintained properly

Refrigerator monitoring and maintenance

middot bullIt is important to carry out routine monitoring and maintenance of the refrigerators and to organize an effective repair system

middot bullThe temperature in the refrigerator must be monitored and recorded routinely at least once a day

middot Any breakdown must be reco rded including the period during which the medicines were exposed to uncontrolled temperatures Medicines may then be kept or discarded depending on the problem guidelines or the manufacturers advice

middot Cold chain monitor cards and devices in or on packages that change color or otherwise alert staff to potential damage assist in monitoring (These are likely to be introduced in India soon)

middot It is essential to have a contingency plan in place before a refrigerator breaks down An arrangement can be made to move the contents to a private refrigerator elsewhere in the community or to obtain a regular supply of ice packs until the defect is rectified

Put filled water bottles in the bottom half of the refrigerator door in order to provide cooling in the refri g e r a t o r w h e n t h e r e i s a p o w e r o u t a g e T h i s m i g h t t a k e c a r e o f t h e temperature when there is no current for a couple of hours If the power outage is expected to last for several hours special arrangements such as an inverter UPS have to be made to keep the refrigerator constantly running in the absence of electricity middot Defrost the refrigerator in case of excessive ice formation and preferably at regular

intervals Keep a record of the same

44

2 4 T e m p e r a t u r e c l i m a t i c c o n d i t i o n s

i) Temperature control middot The medicines in a pharmacy need to be stored at appropriate temperatures to

maintain their stability middot An air-conditioned environment where temperature can be controlled is

recommended for pharmacies Air conditioning offers the option of setting the t e m p e rature as per requirements

middot bullIt is ideal to have an air conditioner to maintain the temperature below 25 C as most medicines require storage below this temperature Secondly this temperature is pleasing to both the staff and the visiting customers too

middot In the absence of an air conditioner circulating fans may be used middot This need is felt even more in certain parts of India where temperatures soar above 45

C and some areas where it falls to sub zero temperatures In such cases temperature maintenance is essential to prevent deterioration of medicines due to unnecessary exposure to drastic temperature fluctuations

middot This need is felt even more in certain parts of India where temperatures soar above 45 C and some areas where it falls to sub zero temperat u r e s I n s u c h c a s e s temperature maintenance is essential to prevent deterioration of medicines due to unnecessary exposure to drastic temperature fluctuations

i i ) Humidity or moisture control Moisture or humidity can adversely affect the stability of me dicines such as tablets capsules powders

45

Gelatin capsules become soft and swell on absorption of moisture The drug content of tablets may undergo surface hydrolysis The presence of moisture may encourage the growth of microbes It is therefore essential to control humidity

To reduce the effect of humidity the following suggestions may be followed -middot Open the windows to allow air circulation Use a fan to circulate fresh (outside) air middot In humid climate a dehumidifier is useful for preventing mo i s t u r e d a m a g e ( i n t h e absence of an air conditioner) middot For bulk containers of tabletscapsules do not keep the container open for a long time and replace the lid or closure immediately after taking out the required number of medicines for dispensing middot Do not allow the medicines to touch the floor or the walls The walls may be damp and may cause moisture absorption damaging the product

middot Calibrated thermometers and manometers can be used to detect temperature and humidity in the pharmacy

middot Periodici t y of checking the temperature should be fixed middot The climatic conditions should be recorded and documented middot Temperature charts should be available for ready reference

Documentation is one of the core activities for achieving and maintaining quality It is one of the most essential components of validation Temperatures in various areas

46

including refrigerators should be recorded at a predetermined periodicity usually daily at the hottest time of the day and such documents should be preserved i i i ) Storage conditions A number of storage conditions are mentioned on the labels of medicinal products These conditions have to be properly interpreted and appropriately complied with

According to the Drugs and Cosmetics Rules 1945

1 The term cool place means a place having a temperature between 10 C and 25 C

2 The term cold place means a place having a temperature not exceeding 8 C In case of storage conditions for specific products please refer to Schedule P The Drugs and Cosmetic Rules 1 9 4 5

The Indian Pharmacopoeia specifies the following storage conditions -

Wherever the condition for storage is not specified medicines may be stored under normal temperature In a country like India however where normal temperatures soar to h i gh temperatures it is recommended that medicines be stored in a cool place

Activity Prepare a list of the storage requirements mentioned on the label of about 20 products in your pharmacy and check if the temperature is maintained

47

25 Special Storage o f s u p p l i e s If the product has no special instructions normal storage conditions apply This means storage in dry clean w e l l -ventilated premises at temperatures of +15 C to +25 C or depending on the climate up to +30 C (WHO1990) Storage instructions are product specific Different brands of the same generic drug may have different storage requirements as they may have different packaging or formulations It is essential to follow the product manufacturers storage instructions to the maximum extent possible Less stable medicines must be stored in specific conditions to maintain their quality or potency

The following products require special storage facilities

middot Products that must be kept frozen (usually vaccines and sera) middot Products sensitive to h eat an d r e q uir in g r e f r ig e r a tio n ( +2 C to +8 C) middot Products that have reduced shelf life at uncontrolled room temperature and need

mechanical ventilation or air conditioning middot Flammable products that require separate fireproof premises middot Products prone to theft o r m i s u s e

Products needing storage in a controlled environment -

The usable shelf life of the following products may be reduced if stored at uncontrolled humidity or at room temperature in hot climates -

middot Some injectables (eg adrenaline) Most injectable preparations are less stable than solid oral forms (tablets and capsules) Injectable preparations in solution are particularly unstable Many injections must be protected from light as well as heat

middot Intravenous fluids (particularly if packed in p lastic containers) middot Some suppositories pessaries creams and ointments These products may melt at

temperatures greater than 30 C Once this happens it is not advisable to use them because the active ingredient in the formula may get unevenly distributed

middot Products containing rubber latex cellulose or some plastics Condoms most sterile disposable medical devices and surgical products such as syringes needles and catheters require protection from excessive humidity and strong light and heat Any o f these conditions may make products brittle stained amp unusable Sterility cannot be assumed if packaging is damaged

In hot climates these products should be stored in the coolest place possible preferably with air conditioning or air circulation fans

48

Products needing freezing or refrigeration-middot Vaccines blood products and many other medicines lose potency if kept even for a

brief period at temperatures outside the recommended range For these products the cold chain must be maintained at every stage of the distribution system

middot Freezing is as damaging as high temperatures for some products including injectable contraceptives ergometrine insulin adrenaline and the DPT DT TT and Hepatitis B vaccines Such products therefore sho uld not be allowed to freeze (not be kept in the freezer compartment)

middot Short periods at room temperature (during transportation or local distribution for instance) may be acceptable for many products (such as ergometrine a n d i n s u l i n ) e v e n t h o u g h s u c h e x posure can to some extent reduce shelf life Other items such as vaccines should always be transported in cold boxes

Storage of insulin injections-

middot Insulin should always be stored in a refrigerator at the recommended temperature of 2 -8 C

middot Insulin should not be kept in the freezer compartment of the refrigerator middot Insulin should ideally be stored horizontally middot It should not be exposed to sunlight or excessive heat middot Insulin suspensions should not be used if the suspension cannot be properly

resuspended due to cake or clump formationbull

Controlled drugs -Narcotics (for example Pethidine injection morphine preparations) and other specified drugs that may be abused are governed by special legislation and regulations The following security measures are suggested in the pharmacy -middot A safe or reinforced double locked cabinet fitted with a light (preferably with a red

bulb) that comes on when the door is opened

49

middot A special register recording details of each receipt or issue with 2 signatures physi cal counting of medicines after each entry and signatures at handover takeover

middot Independent audit (by supervisors and drug inspectors)

Products prone to theft abuse or misuse -

Some medicinesproducts are particularly prone to theft abuse or misuse These include expensive medicines (eg insulin) certain antibiotics and products prone to abuse or misuse like psychotropics etc

Such medicinesproducts should be stored adequately They require stricter record keeping and more frequent stock taki ng than others Periodic audits should be carried out to check for consumption against actual recorded use (registers prescription records stock records etc) to expose any theft or misuse bull26 Storage and stability of medicines Medicines are not stab le indefinitely They are stable for a specific period of time sometimes for a brief period Poor storage conditions accelerate the drug degradation (decomposition) Temperature light and moisture are the most important contributing factors for drug instability It is important to identify and be aware of the potential for instability There is a need to comply with storage requirements to ensure quality medicines for patients It is also important to offer advice to patients too about appropriate storage o f medicines at home The dispensing label should state the storage condition required and be backed up by a verbal reminder especially where special storage is required bull

50

In case stability and storage problems are seen with formulations they should be reported immediately to the representative of the manufacturer and taken out of circulation till the stability problems have been resolved

The pharmacist can easily detect stability problems when products show change in appearance color odor settling of the product contents breaking of emulsions melting of creams oozing of contents from the containers and any such physical changes

3 STOCK CONTROL AND EXPIRY MONITORING 3 1 S t o c k C o n t r o l For economic reasons pharmacists do not like to have stock on their shelves for long periods of time The aim should always be to keep stock at a level that will just meet demand Normally most manufactured medicines have a long shelf life Even then it is essential that there is efficient stock rot ation so that the older stock is used first It is also a good practice to check the expiry date as an integral part of the dispensing process When short shelf life products are involved stock levels may have to be modified to prevent medicines regularl y expiring on the shelves

32 Stock rotation and expiry monitoring In order to avoid accumulation of expired and obsolete stock medicines should be stored and issued according to the following guidelines -middot The stock control system must record the ex p i r y d a t e a n d t h e d a t e o f r e c e i p t middot Stock must be stored so that earliest expiring batches are picked and issued first middot The First In First Out (FIFO) system - In this system the stock which is received

first is sold first This system however may not be useful for pharmacies because most of the stocks carry an expiry date For pharmacies the FEFO system is more practical

51

middot The First Expiry First Out (FEFO) system - In this system the stock having an earlier expiry is sold first The stock with longer shelf life should be placed farthest to the back (or at the bottom in case o f sta c k e d b oxe s) T h is is pa r tic u la r ly impor ta n t with products that have short shelf lives such as vaccines some vitamins antibiotics etc and reduces losses due to expiry

middot E x p i r y dates should be noted on the stock record upon receipt Stock nearing expiry should not be accepted unless it can be used before expiry

Computerization and expiry monitoring In the pharmacy computerization facilitates both checking stocks and expiry mo nitoring and helps-bullbullKeeping a check on products nearing expiry bullbullKeeping a check on non- moving and slow moving products bullbullTo facilitate the removal of medicines nearing expiry from shelves in time to send them back to the wholesaler or supplier

Periodic checking for expiry The expiry date for medicinal products is a critical aspect in pharmaceutical dispensing and due importance should be given to it Periodic checking for expiry of medicines will ensure that the patient will never receive products that have crossed their expiry date During periodical checking of expiry the personnel involved should remove medicines that are nearing expiry bullbullIn -house threshold periods should be set and followed for retrieval of such medicines from the shelves bullbullSuch medicines should be stored separately These should either be dispensed immediately (thus ensuring that they are used before the expiry date) o r t h e y s h o u l d b e returned to the suppliers bullbullA separate area should be designated (cupboard or shelf)marked[FROZEN ZONE] which is adequately marked EXPIRED GOODS- NOT FOR SALE to store all expired stocks FROZEN ZONE

52

Remember Expired medicines are a NATIONAL WASTE So stock only what you can sell Avoid expiries save precious medicines for the nation

Treatment and disposing of expired medicines bullbullProcedures need to be in place for the treatment of expired medicines bullbullThe expired medicines need to be collected and be sent back to the supplier or company for appropriate disposal bullbullRecords must be maintained for expired medicines and how they are disposed off bullbullIn case of medicines that are not returnable to suppliers procedures for disposal need to be followed by the pharmacy in conjunction with the FDA The following procedure can be followed if medicines cannot be returned to suppliers ( T h e b a s i c p h i l o s o p h y of appropriate disposal is to prevent their re- circulation and use) bullbullC u t t h e c o n t ainer in such a manner that the label is also cut In case of tablets and c a p s u l e s d e s t r o y them by disposing them in a bucket of water bullbullUse landfill procedures (deep burial into the ground as per stipulations of Medical Waste Disposal Act prevalent in the respective state) bullbullPour the liquids into the sink and wash away with sufficient quantity of water bullbullKeep a record of such disposal with full details of medicines destroyed Although these measures are usually adopted care has to be taken with such tr e a t m e n t a s studies have shown that flushing of medicines has resulted in tracessmall quantities of medicines being found in waterways and groundwater having potential health and environmental effects

4 O T H E R A S P E C T S 41 Design of storage areas The following important factors need to be considered in design of storage areas -middot The retail outlets in hot areas in summers should be air-conditioned Similarly in

a r e a s o f e x t r e m e c o l d t h e p r e m i s e s w o u l d r e q u i r e w a r m i n g e s p e c i a l l y i n w i n t e r s t o maintain cool temperatures The placement of air -conditioners and heating devices should be such that medicines are not directly exposed to the cold or heat

middot Due consideration should be given to storage requirements of formulations while designing shelves and cupboards in retail outlets Sufficient shelf height should be provided so that all liquid products can be stored vertically As far as possible the shelves should be covered with glass panels to protect medicines from dust and p r e v e n t r a p i d f l u c t u a t i o n s i n temperature

middot Medicines should be stored according to the storage instructions on the labels bullIt is ideal to have a door at the pharmacy entrance to prevent dust from coming in as well as reduceprevent cooled air from going out This may not however be considered feasiblepracticable by many pharmacy owners for fear that clients may not enter the pharmacy because the door may act as a barrier An air curtain is a good alternative to a door

middot There should be minimal direct sunlight falling on the products Particular consideration should be given to premises directly facing the sun

middot bullThe arrangement of lighting in the interior of the premises should also be in a manner that the lights are not focused on the products It has been shown that light causes not only chemical damage but also can catalyze physical changes like moisture uptak e by the products Care should be taken to ensure that only diffused light falls on them

53

middot As far as possible provision should be made for a temperature and humidity indicator device in a pharmacy These devices are now easily available

middot Stability studies o f m e d i c i n e s p a c k e d i n b l i s t e r s h a v e r e v e a l e d t h a t i f t h e s e a r e exposed to light they tend to absorb moisture It is therefore necessary to store them in suitable cartons so that the blisters are not exposed to light Pharmacists should do this even if the manufacturer has not provided cartons

middot Light and temperature sensitive products should not be stored on counters where the light is intense or direct and there is no protection from temperature and humidity

42 Cleaning and maintenance i) Cleaning of storage areas

The storage areas of the pharmacy should be cleaned periodically and cleanliness should be maintained at all times The Standard Operating Procedure for cleaning should be designed and followed accordingly Schedules for cleanups should be laid down and adequate cleaning equipment should be made available

Tips for maintaining cleanliness middot Provide clean pieces of cloth for wiping at various locations in the pharmacy

Replace with clean cloth at regular intervals middot Keep separate pieces of cloth for floors shelves and medicines middot Use a disinfectant andor soap solution to clean floors middot Ensure removal of dust and prevent accumulation of dirt middot Ensure removal of cobwebs middot Use a vacuum cleaner for cleaning areas not easily reachable middot T a k e c a r e t h at breakages are handled and cleared effectively middot Observe the factors leading to waste generation in the pharmacy and take appropriate

measures to tackle the problem middot Record all cleaning procedures performed and maintain all the documents required

For ex a m p l e -bullbullThe floor of the pharmacy may be swept with a broom and swabbed with soap water every morning bullbullThe floor may be swabbed with a disinfectant every week bullbullThe entire premises including shelves and cupboards may be cleaned with a cloth (to remove dust and to check for medicines approaching expiry date or expired medicines) every three months bullbullAll the steps followed should be r e c o r d e d

The floor shelves drawers have to be cleaned and a check should be kept on dust cobwebs spillages due to breakage etc It is therefore essential to have SOPs for cleaning laying down cleaning frequencies allotting responsibilities and maintaining a daily record in the logbook to document all these activities

54

While cleaning dust settled on dosage forms like bottles tubes etc should be removed Before dispensing the products should also be wiped to remove any dust settled during storage

For refrigerators bullbullDefrosting and cleaning should be done at regular intervals bullbullSwitch off the refrigerator while cleaning bullbullCleaning should be done quickly and stocks put back immediately

i i ) Pest control Pests are a serious problem in India where insects reptiles and rodents (eg cockroaches l i z a r d s r a t s s i l v e r f i s h (Deemak - in Hindi ) etc) may find access to the pharmacy storage areas Insects like ants and borer ants may often attack wood in the pharmacy causing d am ag e to shelves cupboardsPest c ontr o l in a p h a r m a c y c a n b e a d i f f i c u l t t a s k b u t t o avoid possible contamination and physical damage to stock it is necessary to keep pests out of the pharmacy premisesPest control measures should be implemented with proper p r e c a u t i o n s t a k i n g u t m o s t c a r e t o a v o i d contamination of medicines

55

Th e following pest control measures c a n be ta ke n f r om tim e to tim e -bullbullRat bait and traps can be placed at various locations bullbullInsecticutors can be used on a permanent basis bullbullInsecticidal sprays and repellants can be used from time to time

i i i ) Fire precautions

Combustible trash such as cartons boxes and other packing waste must not be allowed to accumulate in the store Waste should be deposited in appropriate waste bins and be d i s p o s e d o f f o n a d a i l y b a s i s

F i re detection and fire fighting equipment must be maintained and regularly inspected The pharmacy personnel should receive adequate training in fire fighting techniques and emergency actionFire prevention measures should include a prominently displayed ldquoNoSmokingrdquo sign careful handling and disposal of combustible waste materials and checking of electrical connections at regular intervals

iv) Security middot Doors shutters of the pharmacy should be strong and be fitted with secure locks middot Counters should be designed so that unauthorized personnelclients do not have

access to areas where prescription medicines are stored Access to such areas should be restricted to the pharmacy staff

middot All the pharmacy staff handling supplies should be accountable for their ac t i o n s

56

middot bullSpecial care must be taken in case of Schedule X and manufactured drugs (under NDPS Act) Such medicines should be kept under lock and key and the key should be kept with the Chief Pharmacist or i n h i s a b s e n c e t h e s e n i o r p h a r m a c i s t

v) Breakagespillage and damaged product Products that have been damagedspoiled during storage and handling spillages and broken glassware should be disposed off according to procedures laid down by the pharmacy Broken and damaged products s h o u l d b e p l a c e d i n a segregated area to be returned to the supplier

vi) Inspection Senior staff should inspect all pharmacy areas regularly The shelves and drawers should b e c h e c k e d d a i l y f o r signs of pests and dust Ceiling and walls should be checked for dirt and cobwebs Stock should be checked on a regular basis for deterioration due to climatic conditions

43 Product recalls Products found to be defective should be quickly recalled (withdrawn from the market) The instructions are generally issued either by the manufacturer or the regulatory agency The level of recall is determined by both the degree of risk and the extent of distribution of the product and in India is mainly directed at the distribution chain

On receiving the details of the defective substandard spurious batchbatches of a medicine to be recalled from the manufacturer or the stockist or the FDA the pharmacy should immediately check if the particular b a t c h i s i n s t o c k a n d i f s o s u s p e n d i t s s a l e immediately

Similarly if the regulatory authority in the country bans a particular medicine or FDC the pharmacy should immediately check and remove all the different brands of that particular medicine under consideration

The details of medicines and their batches to be recalled should be available in the q u a r a n t i n e a r e a w h e r e stocks are received and checked This is to ensure that such medicines do not come into the pharmacy

middot The pharmacy should develop SOPs for recall of medicines middot The pharmacy staff should be immediately informed about such medicines and

the details should be displayed in writing in a prominent place in the pharmacy middot Rapid action helps avoid unnecessary exposure to such medicines once the

problem has been d e t e c t e d middot The progress of the recall procedure in the pharmacy should be monitored every

few days to ensure complete compliance middot All stocks of the recalled products should be stored separately from the saleable

stock These can be stored in the expiry cupboard segregated from the expired goods and be appropriately labeled ldquoRecal l e d G o o d s - Not for Salerdquo

The supplier should be notified and asked to replace defective products middot All the details of the procedures followed should be duly recorded in a Recall

Register maintained specially for the purpose The register should include d etails such as -middot Date of the recall middot Nam e of the product

57

bullbull

middot Details of the product (name of manufacturer batch number expiry date) middot Nu m b er of units purchased sold a n d sto c k in ha nd middot Reason for recall middot Nam e of the supplier to whom produc ts w e r e returned along with the date and quantity middot Name and signature of the designated personnel carrying out the recall procedure and recording details middot Name and signature of the chief pharmacist verifying the recall procedures and recording details 4 4 Returned medicines

Medicines may be returned to the pharmacy by clients due to the following reasons -bull

bullbull Unused medicines bullbull Course not completed bullbull Therapy changed by doctor bullbull Side effects experienced by patient bull

bullbull DamagedDefective medicines bullbull Missing or defaced label bullbull Missing tablets in a stripblister bullbull Leakage in bottles bullbull Leakage in strips bull

bullbull Expired medicines

Appropriate SOPs should be framed and followed for their acceptancerefusal and disposal middot bull For unused medicines returned by clients the p harmacy personnel should verify

that these were purchased from their pharmacy They should then be checked for integrity of the packing the dosage form and the expiry date and verified with the client whether they were stored in appropriate conditions This again is at the discretion of each pharmacy

middot The damageddefective medicines returned to the pharmacy should be taken back and stored separately Existing stock of the same product should be checked for similar defects

middot Expired medicines should be accepted from clients at the discretion of the pharmacist and be immediately shifted to the expired goods cupboard These can be stored segregated from the pharmacys own expired goods and be appropriately labelled ldquoExpired Goods returned by clients- Not For Salerdquo

It is advisable not to accept returned medicines requiring cold chain storage (refrigeration) because it cannot be ensured that the cold chain was maintained when the medicines were in the hands of the patientclient middot Appropriate adjustments in t he stocks should be made for medicines

returnedexchanged to update the inventory middot The medicines should then be returned to the respective shelves middot A lsquoReturned Goodsrsquo register needs to be maintained to record all details of returned

medicines

R egister should include such details as-

58

middot N a m e o f t h e p a t i e n t middot Nam e of the product and quantity r e tu r n e d middot Product details such as the batch number and expiry date middot Condition in which received middot Reason for returning products middot Compensatory measures taken wi t h r e s p e c t t o c l i e n t middot Action taken with respect to product middot Name and signature of the personnel accepting the returned medicines and recording details middot Name and signature of the chief pharmacist verifying the recorded details

What the pharmacist would have learnt from this module The storage of medicines is a critical factor in the distribution cycle bullbull Stocks received by the pharmacy should be quarantined in a separate area and necessary checks s h o u ld be performed to ascertain the qua lity a nd quantity of stocks received bullbull Whatever pattern and means of storage used the products should be stored so as to maintain their potency and integrity bullbull Storage conditions should be monitored and maintained on a regular basis bullbull Optimum stock levels should be maintained and regularly monitored for expiry bullbull The design of storage areas should facilitate appropriate storage of medicines bullbull Cleanliness should be maintained in the pharmacy bullbull Adequate measures should be taken in case of returned medicines and recalled products

Optimum storage of medicines is mandatory whether at the distribution stage at the pharmacy or ultimately within the homes of patients The pharmacist has an important r o l e t o p l a y i n t h e s t o r a g e o f m e d i c i n e s i n m a i n t a i n i n g d r u g p o t ency and efficacy and thus facilitating optimum therapeutic benefits Good Pharmacy Practice - IPA -CDSCO - WHO Appendix I Quality Assurance Templates of letters for use if found not of Standard Quality [Frozen and expired goods ]

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated To Name of the Supplier with address

Sub Not of Standard Quality GoMP-Supply of Drugs and medicines-(Codename) Return of Stocks to the Suppliers-reg(New drug policy 2009) Previous letterinvoice ref Sl No Drug Code Drug name

Manufacturing date Expiry date

Supplier address

B a t c h n o

The above items of PO nodated was drawn by the Drug Inspector (Place) on (______________date) as a statutory sampling and declared ldquoNot of Standard

59

Qualityrdquo on -(______________date) by the Government Analyst for the following reasons

- ldquoThe product sample do not confirm to IP specification for (Drug codename with respect to the content of drugrdquo

- ldquoThe product has already been blacklisted by TNMSC on -(______________date) for the failure of (quantity) of batches of drug codenamerdquo

As per the clause of the te nde r d oc um e nt ldquo I f the sa mple s d o not c onf o r m to statutory standardsthe tenderer will be liable for relevant action under the existing laws and the entire stock in such batch should be taken back by the tenderer within a period of 30 days o f t h e r e c e i p t o f t h e l e t t e r f r o m t h e v e n u e

The stock shall be taken back at the expenses of the tendererthe Procurement Authority have the right to destroy such Not of Standard Quality if the tenderer does not take back the goods within the stipulated time

The Procuring Authority will arrange to destroy the Not of Standard Quality drugs within 90 days after the expiry of 30 days mentioned above without further notice and shall also collect demurrage charges calculated at the rate of 2 per week on the value of the drugs rejected till such destructionrdquo

Hence we regret to inform you that you will have to take back the stocks available of the abovesaid batch at your own cost from the drug stores where you have supplied the above batch

Kindly acknowledge the receipt of this reference at once

P r o c u r e m e n t A u t h o r i t y Seal and Stamp

Copy to Ref No dated

1 ) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated13082010

To

Sub Frozen Drugs-ordered to return to the Suppliers-reg(New drug policy 2009) Previous letterinvoice ref

The following products which were earlier frozen have now been ordered to return to suppliers directly with permission from the State drug Authority In this regard the suppliers have been instructed to take back their failed batch from the drug store of the stores Hence you are now instructed to return the following failed batches to the suppliers by obtaining proper authorization letter and acknowledgements from them

60

Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

Kindly acknowledge the receipt of this reference at once

Procurement Authority Seal and Stamp

Copy to

Ref No dated 2) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated14092010

To

Sub Frozen Drugs-ordered to return to the Suppliers- for issue of gate pass after verification reg(New drug policy 2009) Previous letterinvoice ref

The following products which were earlier frozen have now been released Hence they may be issued Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

Kindly acknowledge the receipt of this reference at once

Procurement Authority Seal and Stamp

Copy to

61

Ref No dated 3) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated

To

Sub Stop instruction-reg(New drug policy 2009) Previous letterinvoice ref

Until further instructions stop issue all the batches of the following item Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

You must intimate the available stock in the stores of the said batch Number to the Procurement Authority immediately Also retrieve quantity if already issued

Procurement Authority Seal and Stamp

Copy to

Ref No dated 4) HOD Procurement Office of

62

Appendix II Material handling in drug stores

Rack approx rates and dimensions

S No

Item Description UOM Approx Rate

1 MEDIUM DUTY RACK SIZE 2900 H X 3090 W X 800 D IN MM (AS PER SPECIFICATION)

Each 2499800

2 MEDIUM DUTY RACK ADD ON UNIT FOR SIZE OF SR NO2

Each 2243100

To locate a Box no 3 Rack no 14 in row3

SAMPLE OF RACK no Bin numbering -------------- S a y R K 1 4 R o w 3 B o x 1 6

SAMPLE LAYOUT of RACKS in a Drug Stores

63

Sample of another warehouse of distribution warehouse system

64

65

Slotted Angle racks with bin cards

66

Plastic Pallets

Plastic pallets ar e l i g h t w e i g h t l o w- c ost and exceed industry standards for strength and durability

NOTE A pallet has bottom deckboards (see sketch) A skid does not have bottom

67

deckboards

Battery Operated Stacker

Electric Stacker Ehh (Manual Push Type) - Manual drive - Lifting electrically with Battery 12 V 88 Ah - For loading and un-loading of trucks - Battery and loading device built - in - Battery charge gauge and charging current gauge Simple and Easy Operation - Lifting and Lowering electrically direct on steering arm - Pulling and pushing through steering arm - Electrically operated relief valve on hydraulic aggregate Safe Operation - Emergency Off Switch - Constant lowering speed - Protection through lowering brake valve - Overload protection through overload brake valve - Load chains covered preventing pinching threat - Electrically interlocking during loading process - Secured battery compartment opens upwardly - Stable buffering of the steering arm in upright position - In accordance with EWG Guidelines 89 240 - In accordance with VBG 12b Prevention of Accidents

Pallet Truck [ Top ]

68

----------------------------------------------------------------------------------------------------------------------------

For Transport Of All Goods On Pallets Safe and Easy Operation - through single hand operation Lifting moving

lowering with steering handle - neutral position of the hydraulic possible - overload pressure relief valve Long Service Life - robust co n s t r u c t i o n

- special hardened axles - hardened chromium plated ram - maintenance free Easy Maneuverability - through rubber steering rollers - nylon fork rollers

A h a n d t r o l l e y

69

Trolley with plastic bins for several items del ivery

70

Digital Weighing balances

Balances amp Scales EF Seriers Precision Electronic Balance

71

1

Ice lined Refrigerators

600 litres refrigrator

72

Walk in cooler

vacuum cleaner

73

ANNEXURE -H

PROFORMA FOR BREAKAGE amp LOSS

NAME OF OFFICEINSTITUTION DATE PLACE

SRNO NAME amp

DESCRIPTION OF ARTICLE

COST DATE OF PURCHASE

REASON CAUSE OF BREAKAGE

RECOMMENDATION OF INVESTIGATING AUTHORITY

Signature

Orders of the Competent Authority

Signature

27

Annexure ndash I Loss- Procedure for Reporting

1 The exact nature of the defalcation 2 The full extent of loss 3 The actual period covered by the defalcation 4 The defects in the negle c t o f r u le s by w hic h the loss was rendered possible

and circumstances which facilitated the defalcation 5 The names of the officials held personally or technically directly or

indirectly and wholly or partially responsible for the irregularity c o m m i t t e d i n t h e c a s e

6 Whether the c a s e a s b e e n J u d i c i a l l y t r i e d i n a c o u r t o r n o t i f s o c o p i e s ( i n duplicate) of the Judgment may please be furnished Copy of police report may also be furnished

7 The remedial measures adopted as safeguards against the losses hereafter 8 The prospects of re covery of the loss and he action taken to effect

recovery together with the amount recovered 9 Head of Account to which the Loss is debitable may be informed

Signature of Head of Office with seal

NoteA copy of this report is to be sent to AGMPThis is as per M P Finance Code Vol I

28

STORAGE AND STOCK MANAGEMENT

29

Foreword

The New Drug Policy 2009 is being implemented in the State of Madhya Pradesh

In order to have a proper procedure for Storage maintenance and expiry management of the drugs it is necessary to follow Good Storage Practices with Standard Modules for pharmacistStore keepers

Proper guidelines on Storage Practices can lead to better Stores and inventory upkeep with medicines being properly stored in racks with proper cleanliness and hygiene

This is a step towards storage maintenance and expiry management at the various stores in the state Looking forward to see that the heads of all health facilities take benefit from this module

D ir e c t o r M e d i c a l S e r v i c e s

30

INDEX

Sr No P a r t i c u l a r s P a g e

1 S T O R A G E A N D S T O C K M A N A G E M E N T 4

1 Quarantine and checking of stocks 11 Quarantine area 12 Checks to be carried out on new stocks

2 S t o r a g e 21 Need for proper storage 22 Different patterns of storage 23 Different means of storage 24 Temperatureclimatic conditions 25 Special storage of supplies 26 Storage and stability of medicines

3 Stock Control and Expiry Monitoring 31 Stock control 32 Stock rotation and expi r y m o n i t o r i n g

4 Other aspects of storage 41 Design of a storage area 42 Cleaning and maintenance 43 Product recalls 44 Returned goods

2 A p p e n d i x 1 Templates of letters for use if found not of Standard Quality [Frozen and expired goods ]

Frozen Drugs-ordered to return to the Suppliers-reg(New drug policy 2009)

Frozen Drugs-ordered to return to the Suppliers- for issue of gate pass after verification reg(New drug policy 2009) Stop instruction-reg(New drug policy

2009) Appendix II Material handling in drug stores

31

3 PROCUREMENT ndash Government Order Relating to

the Management of Stores

(Reproduced for reference material on basic

procedure in decentralized system followed by

Health facilities in 1977)

54

F L O W C H A R T S f o r a BI R D S E Y E V I E W o f

P R O C U R E M E N T

5 5

ACQUISITION OF STORES 6 1

PLACING OF ORDERS 6 2

RECEIPT OF STORES 6 2

CUSTODY 6 3

ISSUE OF STORES Maintenance of Stock Books

6 3

PROCEDURE OF INDENTING FOR WARD amp OTHER SECTIONS OF THE INSTITUTION

6 4

HOW OFTEN TO INDENT 6 5

EMERGENT INDENT 6 5

HOW TO INDENT 6 5

KEEPING OF RECORDS IN WARDS A N D S E C T I O N S

6 6

ACCOUNTABILITY OF DRUGS BROUGHT BY THE PATIENT OR RECEIVED IN DON A T I O N BY T H E WARDSECTION _IN - CHARGE

6 7

RESPONSIBILITY OF STORES AT VARIOUS LEVELS

6 7

DISTRIBUTION OF MEDICINES FROM OUTDOOR DEPARTMENT

6 7

LOSS BREAKAGE DAMAGE ETC 6 8

PROCEDURE FOR WRITING OFF STORES 6 9

DISPOSAL OF WRITTEN OFF ARTICLES 7 1

FORMATS TO BE USED 7 3 - 81

32

STORAGE AND STOCK MANAGEMENT The expiry periods of pharmaceutical products have meaning only if the products are stored under proper conditions otherwise products are likely to lose their potency before the actual date of expiry

A pharmacist is a vital link in the distribution chain for pharmaceutical products The medicinal products remain for a long period during the distribution cycle at the wholesaler and at retail pharmacies It is therefore very important to maintain proper storage conditions in these units

Every community pharmacy however large or s mall needs to store and manage its medicine stocks effectively There must be systems to ensure

middot bullbull Secure storage middot bullbull Clean and correct environmental conditions during storage middot bullbull Accurate and effective record keeping middot bullbull Effective stock rotation and expiry monitoring middot bullbull Effective fire and theft prevention middot bullbull Effective rodent pest control

For easier un derstanding this module has been divided into the following sections

1 Quarantine and checking of stocks 11 Quarantine area 12 Checks to be carried out on new stocks

2 S t o r a g e 21 Need for proper storage 22 Different patterns of storage 23 Different means of storage 24 Temperatureclimatic conditions 25 Special storage of supplies 26 Storage and stability of medicines

3 Stock Control and Expiry Monitoring 31 Stock control 3 2 S t o c k r o t a t i o n a n d e x p i r y m o n i t o r i n g

4 Other aspects of s t o r a g e 41 Design of a storage area 42 Cleaning and maintenance 43 Product recalls 44 Returned goods

33

1 QUARANTINE AND CHECKING OF STOCKS

11 Quarantine Area D r u g S t o r e pharmacies receive stoc k s f r o m su pplie r s a c c or d ing to pur c h a se o r d e r s T he stock that is received must be visually checked for quality and quantity The stocks must be kept in a separate area until the checking is done to avoid intermixing with existing stock This necessitates the presence of a separate area within the pharmacy w h e r e i n t h e storage and other checking of stocks can be performed This area is called the QUARANTINE AREA This area should be marked and identified adequately to distinguish it from other areas

The area may be marked using different means 1 ) A s m a l l board saying Quarantine on a separate table used exclusively if it is in the middle 2) A board on the wall if the table on which the quarantine stock is placed is against the wall

middot Stock received from wholesalers should be immediately transferred t o t h e Quarantine Area

middot In the Quarantine area the stock may be stored on racks shelves or in cupboards to prevent ingress of moisture dirt and other contaminants

middot Regular stocks from the pharmacy should not be left kept in the quarantine area Special care has to be taken in case of refrigerated medicines supplied by the suppliers so tha t the y do not remain in the quarantine area for long periods of time They should be immediately checked on receipt and transferred to areas for refrigerated storage s o a s to maintain the cold chain bull

Advantages of having a separate Quarantine Area middot Avoids cross mixing of newly arrived stock from existing stock till it is checked middot Lays stress on checking the quality of the stock received middot S to ck checking ensures t hat defective andor expired goods do not enter the storage areas

34

bullbull

bullbull

12 Checks to be carried out on new stock

Unpacking and checking stock

Supplies received should be unpacked and checked in the quarantine area Staff doing the checks should be adequatel y trained in what they have to check when stock arrives

Checking should be seen not simply as counting the units received but as a part of the quality assurance system bullThis should include middot Visually inspecting the packaging middot Checking the integrity of containers middot V erifying the completeness and leg ibility of la b e ls ( a ppr o ve d dr u g name strength any special storage instructions and expiry date)

bull

The expiry dat e should be checked to ensure that there is adequate shelf life remaining

Supplies should be individually checked using a checklist 35

Checklists

36

The wholesaler supplying the product should be notified immediately in case of any discrepancies ( and the details should be recorded in a register) and sent in a written format to the supplier It should include middot Missing boxes or cartons middot O p en tampered boxes or cartons middot Missing supplies middot Differences in the actual quantity and the quantity shown on the packing middot Additional medicines that had not been ordered but have been supplied middot D a m a g e d b r o k e n o r p oor quality medicines middot Any other discrepancies

The purchase invoices are an important aspect to be considered The invoiced documents should be signed and filed for reference as per the Drugs and Cosmetics Act and retained for at least 3years

If the wholesaler supplies medicines as an emergency without a bill or against a delivery challan

middot The supplies should be checked for integrity and inspected for damage middot The details of supplies received should be recorded middot The supplier should be asked t o send the bill as early as possible middot When the bill is received it should be checked against the details recorded and anomalies if any should be reported to the supplier

To keep a track of the received stock maintaining a S t o c k R e c o r d C a r d c a n b e very useful The entries in the stock record card can be made while checking the stock received STOCK BIN in the stores should have Stock record card

Maintaining a stock card for every product may not be very practical for a retail pharmacy however it could be maintained for costly medicines Nowadays it is much more practical and easier to maintain records using computers

The pharmacist should ensure that medicines manufacturedmarketed by a company are received only through an authorized distribution network of that company This is important to prevent spurious and counterfeit drugs from entering the pharmacy

37

2 STORAGE 21 The need for proper storage The storage of medicines and other products is an important requirement of Good Pharmacy Pr actice Appropriate storage of medicines is essential -

middot bullTo ensure that the potency is maintained middot bullTo prevent deteriorationspoilagedegradation middot bullTo ensuremaintain physical integrity

To ascertain that the quality and safety is maintained throughout their shelf life Storage requirements need to be considered on 2 aspects

a) Integrity of medicines Medicines should be stored in such a way so as to maintain their integrity and potency middot Maintain the right temperature required middot Protect from excessive humidity middot Keep medicines away from direct sunlight middot Protect from pests and rodents

b) Physical location middot Should be easy to locate middot Accessible middot Orderlysystematically placed

2 2 D i f f e r e n t p a t t e r n s o f s t o r a g e The pharmacist could follow any of the different patterns of storage The pattern of stora ge should be selected in such a way that it facilitates speedy and efficient dispensing of medicines

The pattern of storage could vary with each pharmacy experience usual practiceroutine of staff and the person-in charge and also depending on space av ailable turnover etc (i) The medicines could be stored c o m p a n y w i s e ie the medicines manufactured by one company should be grouped together and kept in one place Within each company shelfshelves the medicines may be placed in alphabetical order for easy and quick placement and removal Also bottles tubes boxes etc may be segregated within that shelf

38

(ii) The medicines may also be stored in a lphabe t ic al o r de r ie they are placed in order from left to right based on their name The first letter of the name is used to g r o u p t h e m e d i c i n e s t o g e t h e r a n d k e e p t h e m i n o n e l o c a t i o n I n s o m e p h a r m a c i e s a l l t h e strip packing are placed in drawers or boxes in alphabetical order each box or drawer containing strips of one particular alphabet This system ensures that the strips always remain e n c l o s e d i n t h e b o x e s d r a w e r s a n d a r e n o t e x p o s e d t o d u s t T h e d i s a d v a n t a g e i s that it might lead to mix -u p o f strips in the same drawer and it may cause a problem incase of similar looking strips in which case a wrong medicine may be dispensed Secondly cut strips lying around in the drawer may lose their identity if the batch n u m b e r andor expiry date is not seen on the cut portion of the strip

39

(iii) The medicines may be stored according to their therapeutic class ( e g a n t i b i o t i c s anti asthmatics or anti hypertensives) ie the medicines are kept together based on their pharmacological or therapeutic action

(iv) The medicines may be stockedsegregated according to dosage forms eg l i q u i d s (bottles) solid oral dosage forms eye drops rotacaps ointments etc all stored on separate shelves

Always Remember I Storage of prescription medicines should preferably be separate from OTC medicines OTC medicines especially those that a r e a d v e r t i s e d m a y b e d i s p l a y e d f o r c l i e n t s t o select or to ask questions about [OTC-O v e r t h e c o u n t e r ] II Storage according to temperatures is a must no matter which pattern of storage is followed Also within a particular storage area segregated storage may be maintained In a refrigerator for example medicines may be stored in trays racks and the freezer according to the temperature required

40

Whatever pattern of storage is selected all the personnel should ensure that middot The stocks are stored in an orderly manner middot The medicines are kept back in the same place from where they were removed middot All medicines are arranged neatly once in a while

middot The personnel should be careful while storing the medicines middot They should not throw the medicines haphazardly 23 Different means of storage

middot Within each temperature and security zone medicines must be stored so that they are easily accessible and protected against damage

middot Basic means of storage include shelves racks and drawers middot To prevent dust from entering the shelvesracks it is ideal to have glass

shutterssliding glass doors This can however be disadvantageous because accessibilityspeed is hampered in removing a product from the shelf because the glassshuttersliding glass has to be

41

opened m o v e d e v e r y t i m e a p r o d u c t h a s t o b e p i c k e d u p U s e o f a i r c o n d i t i o n e r s f o r t h e p h arm acy with a closed door at the e n t r a n c e o r a n a i r c u r t a i n c a n r e d u c e t h e d u s t problem In such cases the shelvesracks may be left o p e n

bull

middot Direct storage of cartons on the floor should be avoided because besides being an unhealthy practice the contents may also be damaged by moisture bull

middot Store medicines preferably in shelves with glass shutters for visibility middot Closed shelves further prevent dust from going in especially in India where most

pharmacies are located along busy roads middot Some medicines have to be refrigerated or stored in a cool or cold place Having a

refrigerator or two (as per the need of the pharmacy) is essential to store suc h medicines at temperatures mentioned on the label bull

42

Refrigeration middot All cold chain equipment should meet required standards middot Improvement in refrigeration technology has provided frost -free refrigerators

Pharmacists should opt for frost-free refrigerators as they are easy to maintain and protect printed packaging materials Conventional refrigerators may cause water falling from trays below the freezer on medicines stored in the refrigerator thus causing soggy labels

middot bull Frost-free refrigerators also provide separate and large compartments for the freezer portion (required for storing medicines needing sub-z e r o t e m p e r a t u r e ) and the main storage area with separate doors so that opening one door does not disturb the storage temperature in the other compartment

Care should be taken to keep the refrigerator on 24 hours a day It should not be switched off after working hours It is advisable to have an inverter connected to the refrigerator so that the refrigerator re mains working even when there is a power outage

middot The refrigerator door should be closed tightly middot The refrigerator door should not be left open for too long middot Space should be left between medicines stored in a refrigerator to allow air to

circulate middot The ref rigerator should be placed about an arms length away from the wall

This will increase air circulation thus not affecting the cooling within the refrigerator

middot Vaccines should not be stored on refrigerator door shelves as they are exposed to warmer temperatures each time the door is opened Vaccines should always be stored on the middle shelves of the refrigerator

middot Refrigerated medicines should not be left out of the refrigerator for more than a few minutes

43

middot Consumable products like juices energy drinks e t c s h o u l d n o t b e s t o r e d a l o n g with medicines in refrigerators If required they may be kept in a separate refrigerator

middot An adequate number of refrigerators should be planned to store the entire stocks requiring refrigerated storage

middot Adequate procedures should be followed for defrosting cleaning and maintenance of refrigerators

middot Icefreeze packs should be kept in the freezer compartment so that they can be used for transporting cold temperature medicines The packs can be given to clients along with the medicines requiring cold temperature storage so that the temperature is maintained till the client reaches home and can then put the medicines in a refrigerator) Freezer packs can also be used to keep medicines temporarily in case there is a power outage or refrigerator breakdown

Activity

Prepare a SOP (Standard operating procedure chart) for cleaning a refrigerator Discuss it with your staff finalize its maintenance once a month through AMC -A n n u a l Maintenance contract CMC - Comprehensive maintenance contract and put it up on the pharmacy refrigerator Put the Purchase Order details name of manufacturer Phone of Service Engineer and a register to login the Machine service and down timeService reports may be maintained properly

Refrigerator monitoring and maintenance

middot bullIt is important to carry out routine monitoring and maintenance of the refrigerators and to organize an effective repair system

middot bullThe temperature in the refrigerator must be monitored and recorded routinely at least once a day

middot Any breakdown must be reco rded including the period during which the medicines were exposed to uncontrolled temperatures Medicines may then be kept or discarded depending on the problem guidelines or the manufacturers advice

middot Cold chain monitor cards and devices in or on packages that change color or otherwise alert staff to potential damage assist in monitoring (These are likely to be introduced in India soon)

middot It is essential to have a contingency plan in place before a refrigerator breaks down An arrangement can be made to move the contents to a private refrigerator elsewhere in the community or to obtain a regular supply of ice packs until the defect is rectified

Put filled water bottles in the bottom half of the refrigerator door in order to provide cooling in the refri g e r a t o r w h e n t h e r e i s a p o w e r o u t a g e T h i s m i g h t t a k e c a r e o f t h e temperature when there is no current for a couple of hours If the power outage is expected to last for several hours special arrangements such as an inverter UPS have to be made to keep the refrigerator constantly running in the absence of electricity middot Defrost the refrigerator in case of excessive ice formation and preferably at regular

intervals Keep a record of the same

44

2 4 T e m p e r a t u r e c l i m a t i c c o n d i t i o n s

i) Temperature control middot The medicines in a pharmacy need to be stored at appropriate temperatures to

maintain their stability middot An air-conditioned environment where temperature can be controlled is

recommended for pharmacies Air conditioning offers the option of setting the t e m p e rature as per requirements

middot bullIt is ideal to have an air conditioner to maintain the temperature below 25 C as most medicines require storage below this temperature Secondly this temperature is pleasing to both the staff and the visiting customers too

middot In the absence of an air conditioner circulating fans may be used middot This need is felt even more in certain parts of India where temperatures soar above 45

C and some areas where it falls to sub zero temperatures In such cases temperature maintenance is essential to prevent deterioration of medicines due to unnecessary exposure to drastic temperature fluctuations

middot This need is felt even more in certain parts of India where temperatures soar above 45 C and some areas where it falls to sub zero temperat u r e s I n s u c h c a s e s temperature maintenance is essential to prevent deterioration of medicines due to unnecessary exposure to drastic temperature fluctuations

i i ) Humidity or moisture control Moisture or humidity can adversely affect the stability of me dicines such as tablets capsules powders

45

Gelatin capsules become soft and swell on absorption of moisture The drug content of tablets may undergo surface hydrolysis The presence of moisture may encourage the growth of microbes It is therefore essential to control humidity

To reduce the effect of humidity the following suggestions may be followed -middot Open the windows to allow air circulation Use a fan to circulate fresh (outside) air middot In humid climate a dehumidifier is useful for preventing mo i s t u r e d a m a g e ( i n t h e absence of an air conditioner) middot For bulk containers of tabletscapsules do not keep the container open for a long time and replace the lid or closure immediately after taking out the required number of medicines for dispensing middot Do not allow the medicines to touch the floor or the walls The walls may be damp and may cause moisture absorption damaging the product

middot Calibrated thermometers and manometers can be used to detect temperature and humidity in the pharmacy

middot Periodici t y of checking the temperature should be fixed middot The climatic conditions should be recorded and documented middot Temperature charts should be available for ready reference

Documentation is one of the core activities for achieving and maintaining quality It is one of the most essential components of validation Temperatures in various areas

46

including refrigerators should be recorded at a predetermined periodicity usually daily at the hottest time of the day and such documents should be preserved i i i ) Storage conditions A number of storage conditions are mentioned on the labels of medicinal products These conditions have to be properly interpreted and appropriately complied with

According to the Drugs and Cosmetics Rules 1945

1 The term cool place means a place having a temperature between 10 C and 25 C

2 The term cold place means a place having a temperature not exceeding 8 C In case of storage conditions for specific products please refer to Schedule P The Drugs and Cosmetic Rules 1 9 4 5

The Indian Pharmacopoeia specifies the following storage conditions -

Wherever the condition for storage is not specified medicines may be stored under normal temperature In a country like India however where normal temperatures soar to h i gh temperatures it is recommended that medicines be stored in a cool place

Activity Prepare a list of the storage requirements mentioned on the label of about 20 products in your pharmacy and check if the temperature is maintained

47

25 Special Storage o f s u p p l i e s If the product has no special instructions normal storage conditions apply This means storage in dry clean w e l l -ventilated premises at temperatures of +15 C to +25 C or depending on the climate up to +30 C (WHO1990) Storage instructions are product specific Different brands of the same generic drug may have different storage requirements as they may have different packaging or formulations It is essential to follow the product manufacturers storage instructions to the maximum extent possible Less stable medicines must be stored in specific conditions to maintain their quality or potency

The following products require special storage facilities

middot Products that must be kept frozen (usually vaccines and sera) middot Products sensitive to h eat an d r e q uir in g r e f r ig e r a tio n ( +2 C to +8 C) middot Products that have reduced shelf life at uncontrolled room temperature and need

mechanical ventilation or air conditioning middot Flammable products that require separate fireproof premises middot Products prone to theft o r m i s u s e

Products needing storage in a controlled environment -

The usable shelf life of the following products may be reduced if stored at uncontrolled humidity or at room temperature in hot climates -

middot Some injectables (eg adrenaline) Most injectable preparations are less stable than solid oral forms (tablets and capsules) Injectable preparations in solution are particularly unstable Many injections must be protected from light as well as heat

middot Intravenous fluids (particularly if packed in p lastic containers) middot Some suppositories pessaries creams and ointments These products may melt at

temperatures greater than 30 C Once this happens it is not advisable to use them because the active ingredient in the formula may get unevenly distributed

middot Products containing rubber latex cellulose or some plastics Condoms most sterile disposable medical devices and surgical products such as syringes needles and catheters require protection from excessive humidity and strong light and heat Any o f these conditions may make products brittle stained amp unusable Sterility cannot be assumed if packaging is damaged

In hot climates these products should be stored in the coolest place possible preferably with air conditioning or air circulation fans

48

Products needing freezing or refrigeration-middot Vaccines blood products and many other medicines lose potency if kept even for a

brief period at temperatures outside the recommended range For these products the cold chain must be maintained at every stage of the distribution system

middot Freezing is as damaging as high temperatures for some products including injectable contraceptives ergometrine insulin adrenaline and the DPT DT TT and Hepatitis B vaccines Such products therefore sho uld not be allowed to freeze (not be kept in the freezer compartment)

middot Short periods at room temperature (during transportation or local distribution for instance) may be acceptable for many products (such as ergometrine a n d i n s u l i n ) e v e n t h o u g h s u c h e x posure can to some extent reduce shelf life Other items such as vaccines should always be transported in cold boxes

Storage of insulin injections-

middot Insulin should always be stored in a refrigerator at the recommended temperature of 2 -8 C

middot Insulin should not be kept in the freezer compartment of the refrigerator middot Insulin should ideally be stored horizontally middot It should not be exposed to sunlight or excessive heat middot Insulin suspensions should not be used if the suspension cannot be properly

resuspended due to cake or clump formationbull

Controlled drugs -Narcotics (for example Pethidine injection morphine preparations) and other specified drugs that may be abused are governed by special legislation and regulations The following security measures are suggested in the pharmacy -middot A safe or reinforced double locked cabinet fitted with a light (preferably with a red

bulb) that comes on when the door is opened

49

middot A special register recording details of each receipt or issue with 2 signatures physi cal counting of medicines after each entry and signatures at handover takeover

middot Independent audit (by supervisors and drug inspectors)

Products prone to theft abuse or misuse -

Some medicinesproducts are particularly prone to theft abuse or misuse These include expensive medicines (eg insulin) certain antibiotics and products prone to abuse or misuse like psychotropics etc

Such medicinesproducts should be stored adequately They require stricter record keeping and more frequent stock taki ng than others Periodic audits should be carried out to check for consumption against actual recorded use (registers prescription records stock records etc) to expose any theft or misuse bull26 Storage and stability of medicines Medicines are not stab le indefinitely They are stable for a specific period of time sometimes for a brief period Poor storage conditions accelerate the drug degradation (decomposition) Temperature light and moisture are the most important contributing factors for drug instability It is important to identify and be aware of the potential for instability There is a need to comply with storage requirements to ensure quality medicines for patients It is also important to offer advice to patients too about appropriate storage o f medicines at home The dispensing label should state the storage condition required and be backed up by a verbal reminder especially where special storage is required bull

50

In case stability and storage problems are seen with formulations they should be reported immediately to the representative of the manufacturer and taken out of circulation till the stability problems have been resolved

The pharmacist can easily detect stability problems when products show change in appearance color odor settling of the product contents breaking of emulsions melting of creams oozing of contents from the containers and any such physical changes

3 STOCK CONTROL AND EXPIRY MONITORING 3 1 S t o c k C o n t r o l For economic reasons pharmacists do not like to have stock on their shelves for long periods of time The aim should always be to keep stock at a level that will just meet demand Normally most manufactured medicines have a long shelf life Even then it is essential that there is efficient stock rot ation so that the older stock is used first It is also a good practice to check the expiry date as an integral part of the dispensing process When short shelf life products are involved stock levels may have to be modified to prevent medicines regularl y expiring on the shelves

32 Stock rotation and expiry monitoring In order to avoid accumulation of expired and obsolete stock medicines should be stored and issued according to the following guidelines -middot The stock control system must record the ex p i r y d a t e a n d t h e d a t e o f r e c e i p t middot Stock must be stored so that earliest expiring batches are picked and issued first middot The First In First Out (FIFO) system - In this system the stock which is received

first is sold first This system however may not be useful for pharmacies because most of the stocks carry an expiry date For pharmacies the FEFO system is more practical

51

middot The First Expiry First Out (FEFO) system - In this system the stock having an earlier expiry is sold first The stock with longer shelf life should be placed farthest to the back (or at the bottom in case o f sta c k e d b oxe s) T h is is pa r tic u la r ly impor ta n t with products that have short shelf lives such as vaccines some vitamins antibiotics etc and reduces losses due to expiry

middot E x p i r y dates should be noted on the stock record upon receipt Stock nearing expiry should not be accepted unless it can be used before expiry

Computerization and expiry monitoring In the pharmacy computerization facilitates both checking stocks and expiry mo nitoring and helps-bullbullKeeping a check on products nearing expiry bullbullKeeping a check on non- moving and slow moving products bullbullTo facilitate the removal of medicines nearing expiry from shelves in time to send them back to the wholesaler or supplier

Periodic checking for expiry The expiry date for medicinal products is a critical aspect in pharmaceutical dispensing and due importance should be given to it Periodic checking for expiry of medicines will ensure that the patient will never receive products that have crossed their expiry date During periodical checking of expiry the personnel involved should remove medicines that are nearing expiry bullbullIn -house threshold periods should be set and followed for retrieval of such medicines from the shelves bullbullSuch medicines should be stored separately These should either be dispensed immediately (thus ensuring that they are used before the expiry date) o r t h e y s h o u l d b e returned to the suppliers bullbullA separate area should be designated (cupboard or shelf)marked[FROZEN ZONE] which is adequately marked EXPIRED GOODS- NOT FOR SALE to store all expired stocks FROZEN ZONE

52

Remember Expired medicines are a NATIONAL WASTE So stock only what you can sell Avoid expiries save precious medicines for the nation

Treatment and disposing of expired medicines bullbullProcedures need to be in place for the treatment of expired medicines bullbullThe expired medicines need to be collected and be sent back to the supplier or company for appropriate disposal bullbullRecords must be maintained for expired medicines and how they are disposed off bullbullIn case of medicines that are not returnable to suppliers procedures for disposal need to be followed by the pharmacy in conjunction with the FDA The following procedure can be followed if medicines cannot be returned to suppliers ( T h e b a s i c p h i l o s o p h y of appropriate disposal is to prevent their re- circulation and use) bullbullC u t t h e c o n t ainer in such a manner that the label is also cut In case of tablets and c a p s u l e s d e s t r o y them by disposing them in a bucket of water bullbullUse landfill procedures (deep burial into the ground as per stipulations of Medical Waste Disposal Act prevalent in the respective state) bullbullPour the liquids into the sink and wash away with sufficient quantity of water bullbullKeep a record of such disposal with full details of medicines destroyed Although these measures are usually adopted care has to be taken with such tr e a t m e n t a s studies have shown that flushing of medicines has resulted in tracessmall quantities of medicines being found in waterways and groundwater having potential health and environmental effects

4 O T H E R A S P E C T S 41 Design of storage areas The following important factors need to be considered in design of storage areas -middot The retail outlets in hot areas in summers should be air-conditioned Similarly in

a r e a s o f e x t r e m e c o l d t h e p r e m i s e s w o u l d r e q u i r e w a r m i n g e s p e c i a l l y i n w i n t e r s t o maintain cool temperatures The placement of air -conditioners and heating devices should be such that medicines are not directly exposed to the cold or heat

middot Due consideration should be given to storage requirements of formulations while designing shelves and cupboards in retail outlets Sufficient shelf height should be provided so that all liquid products can be stored vertically As far as possible the shelves should be covered with glass panels to protect medicines from dust and p r e v e n t r a p i d f l u c t u a t i o n s i n temperature

middot Medicines should be stored according to the storage instructions on the labels bullIt is ideal to have a door at the pharmacy entrance to prevent dust from coming in as well as reduceprevent cooled air from going out This may not however be considered feasiblepracticable by many pharmacy owners for fear that clients may not enter the pharmacy because the door may act as a barrier An air curtain is a good alternative to a door

middot There should be minimal direct sunlight falling on the products Particular consideration should be given to premises directly facing the sun

middot bullThe arrangement of lighting in the interior of the premises should also be in a manner that the lights are not focused on the products It has been shown that light causes not only chemical damage but also can catalyze physical changes like moisture uptak e by the products Care should be taken to ensure that only diffused light falls on them

53

middot As far as possible provision should be made for a temperature and humidity indicator device in a pharmacy These devices are now easily available

middot Stability studies o f m e d i c i n e s p a c k e d i n b l i s t e r s h a v e r e v e a l e d t h a t i f t h e s e a r e exposed to light they tend to absorb moisture It is therefore necessary to store them in suitable cartons so that the blisters are not exposed to light Pharmacists should do this even if the manufacturer has not provided cartons

middot Light and temperature sensitive products should not be stored on counters where the light is intense or direct and there is no protection from temperature and humidity

42 Cleaning and maintenance i) Cleaning of storage areas

The storage areas of the pharmacy should be cleaned periodically and cleanliness should be maintained at all times The Standard Operating Procedure for cleaning should be designed and followed accordingly Schedules for cleanups should be laid down and adequate cleaning equipment should be made available

Tips for maintaining cleanliness middot Provide clean pieces of cloth for wiping at various locations in the pharmacy

Replace with clean cloth at regular intervals middot Keep separate pieces of cloth for floors shelves and medicines middot Use a disinfectant andor soap solution to clean floors middot Ensure removal of dust and prevent accumulation of dirt middot Ensure removal of cobwebs middot Use a vacuum cleaner for cleaning areas not easily reachable middot T a k e c a r e t h at breakages are handled and cleared effectively middot Observe the factors leading to waste generation in the pharmacy and take appropriate

measures to tackle the problem middot Record all cleaning procedures performed and maintain all the documents required

For ex a m p l e -bullbullThe floor of the pharmacy may be swept with a broom and swabbed with soap water every morning bullbullThe floor may be swabbed with a disinfectant every week bullbullThe entire premises including shelves and cupboards may be cleaned with a cloth (to remove dust and to check for medicines approaching expiry date or expired medicines) every three months bullbullAll the steps followed should be r e c o r d e d

The floor shelves drawers have to be cleaned and a check should be kept on dust cobwebs spillages due to breakage etc It is therefore essential to have SOPs for cleaning laying down cleaning frequencies allotting responsibilities and maintaining a daily record in the logbook to document all these activities

54

While cleaning dust settled on dosage forms like bottles tubes etc should be removed Before dispensing the products should also be wiped to remove any dust settled during storage

For refrigerators bullbullDefrosting and cleaning should be done at regular intervals bullbullSwitch off the refrigerator while cleaning bullbullCleaning should be done quickly and stocks put back immediately

i i ) Pest control Pests are a serious problem in India where insects reptiles and rodents (eg cockroaches l i z a r d s r a t s s i l v e r f i s h (Deemak - in Hindi ) etc) may find access to the pharmacy storage areas Insects like ants and borer ants may often attack wood in the pharmacy causing d am ag e to shelves cupboardsPest c ontr o l in a p h a r m a c y c a n b e a d i f f i c u l t t a s k b u t t o avoid possible contamination and physical damage to stock it is necessary to keep pests out of the pharmacy premisesPest control measures should be implemented with proper p r e c a u t i o n s t a k i n g u t m o s t c a r e t o a v o i d contamination of medicines

55

Th e following pest control measures c a n be ta ke n f r om tim e to tim e -bullbullRat bait and traps can be placed at various locations bullbullInsecticutors can be used on a permanent basis bullbullInsecticidal sprays and repellants can be used from time to time

i i i ) Fire precautions

Combustible trash such as cartons boxes and other packing waste must not be allowed to accumulate in the store Waste should be deposited in appropriate waste bins and be d i s p o s e d o f f o n a d a i l y b a s i s

F i re detection and fire fighting equipment must be maintained and regularly inspected The pharmacy personnel should receive adequate training in fire fighting techniques and emergency actionFire prevention measures should include a prominently displayed ldquoNoSmokingrdquo sign careful handling and disposal of combustible waste materials and checking of electrical connections at regular intervals

iv) Security middot Doors shutters of the pharmacy should be strong and be fitted with secure locks middot Counters should be designed so that unauthorized personnelclients do not have

access to areas where prescription medicines are stored Access to such areas should be restricted to the pharmacy staff

middot All the pharmacy staff handling supplies should be accountable for their ac t i o n s

56

middot bullSpecial care must be taken in case of Schedule X and manufactured drugs (under NDPS Act) Such medicines should be kept under lock and key and the key should be kept with the Chief Pharmacist or i n h i s a b s e n c e t h e s e n i o r p h a r m a c i s t

v) Breakagespillage and damaged product Products that have been damagedspoiled during storage and handling spillages and broken glassware should be disposed off according to procedures laid down by the pharmacy Broken and damaged products s h o u l d b e p l a c e d i n a segregated area to be returned to the supplier

vi) Inspection Senior staff should inspect all pharmacy areas regularly The shelves and drawers should b e c h e c k e d d a i l y f o r signs of pests and dust Ceiling and walls should be checked for dirt and cobwebs Stock should be checked on a regular basis for deterioration due to climatic conditions

43 Product recalls Products found to be defective should be quickly recalled (withdrawn from the market) The instructions are generally issued either by the manufacturer or the regulatory agency The level of recall is determined by both the degree of risk and the extent of distribution of the product and in India is mainly directed at the distribution chain

On receiving the details of the defective substandard spurious batchbatches of a medicine to be recalled from the manufacturer or the stockist or the FDA the pharmacy should immediately check if the particular b a t c h i s i n s t o c k a n d i f s o s u s p e n d i t s s a l e immediately

Similarly if the regulatory authority in the country bans a particular medicine or FDC the pharmacy should immediately check and remove all the different brands of that particular medicine under consideration

The details of medicines and their batches to be recalled should be available in the q u a r a n t i n e a r e a w h e r e stocks are received and checked This is to ensure that such medicines do not come into the pharmacy

middot The pharmacy should develop SOPs for recall of medicines middot The pharmacy staff should be immediately informed about such medicines and

the details should be displayed in writing in a prominent place in the pharmacy middot Rapid action helps avoid unnecessary exposure to such medicines once the

problem has been d e t e c t e d middot The progress of the recall procedure in the pharmacy should be monitored every

few days to ensure complete compliance middot All stocks of the recalled products should be stored separately from the saleable

stock These can be stored in the expiry cupboard segregated from the expired goods and be appropriately labeled ldquoRecal l e d G o o d s - Not for Salerdquo

The supplier should be notified and asked to replace defective products middot All the details of the procedures followed should be duly recorded in a Recall

Register maintained specially for the purpose The register should include d etails such as -middot Date of the recall middot Nam e of the product

57

bullbull

middot Details of the product (name of manufacturer batch number expiry date) middot Nu m b er of units purchased sold a n d sto c k in ha nd middot Reason for recall middot Nam e of the supplier to whom produc ts w e r e returned along with the date and quantity middot Name and signature of the designated personnel carrying out the recall procedure and recording details middot Name and signature of the chief pharmacist verifying the recall procedures and recording details 4 4 Returned medicines

Medicines may be returned to the pharmacy by clients due to the following reasons -bull

bullbull Unused medicines bullbull Course not completed bullbull Therapy changed by doctor bullbull Side effects experienced by patient bull

bullbull DamagedDefective medicines bullbull Missing or defaced label bullbull Missing tablets in a stripblister bullbull Leakage in bottles bullbull Leakage in strips bull

bullbull Expired medicines

Appropriate SOPs should be framed and followed for their acceptancerefusal and disposal middot bull For unused medicines returned by clients the p harmacy personnel should verify

that these were purchased from their pharmacy They should then be checked for integrity of the packing the dosage form and the expiry date and verified with the client whether they were stored in appropriate conditions This again is at the discretion of each pharmacy

middot The damageddefective medicines returned to the pharmacy should be taken back and stored separately Existing stock of the same product should be checked for similar defects

middot Expired medicines should be accepted from clients at the discretion of the pharmacist and be immediately shifted to the expired goods cupboard These can be stored segregated from the pharmacys own expired goods and be appropriately labelled ldquoExpired Goods returned by clients- Not For Salerdquo

It is advisable not to accept returned medicines requiring cold chain storage (refrigeration) because it cannot be ensured that the cold chain was maintained when the medicines were in the hands of the patientclient middot Appropriate adjustments in t he stocks should be made for medicines

returnedexchanged to update the inventory middot The medicines should then be returned to the respective shelves middot A lsquoReturned Goodsrsquo register needs to be maintained to record all details of returned

medicines

R egister should include such details as-

58

middot N a m e o f t h e p a t i e n t middot Nam e of the product and quantity r e tu r n e d middot Product details such as the batch number and expiry date middot Condition in which received middot Reason for returning products middot Compensatory measures taken wi t h r e s p e c t t o c l i e n t middot Action taken with respect to product middot Name and signature of the personnel accepting the returned medicines and recording details middot Name and signature of the chief pharmacist verifying the recorded details

What the pharmacist would have learnt from this module The storage of medicines is a critical factor in the distribution cycle bullbull Stocks received by the pharmacy should be quarantined in a separate area and necessary checks s h o u ld be performed to ascertain the qua lity a nd quantity of stocks received bullbull Whatever pattern and means of storage used the products should be stored so as to maintain their potency and integrity bullbull Storage conditions should be monitored and maintained on a regular basis bullbull Optimum stock levels should be maintained and regularly monitored for expiry bullbull The design of storage areas should facilitate appropriate storage of medicines bullbull Cleanliness should be maintained in the pharmacy bullbull Adequate measures should be taken in case of returned medicines and recalled products

Optimum storage of medicines is mandatory whether at the distribution stage at the pharmacy or ultimately within the homes of patients The pharmacist has an important r o l e t o p l a y i n t h e s t o r a g e o f m e d i c i n e s i n m a i n t a i n i n g d r u g p o t ency and efficacy and thus facilitating optimum therapeutic benefits Good Pharmacy Practice - IPA -CDSCO - WHO Appendix I Quality Assurance Templates of letters for use if found not of Standard Quality [Frozen and expired goods ]

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated To Name of the Supplier with address

Sub Not of Standard Quality GoMP-Supply of Drugs and medicines-(Codename) Return of Stocks to the Suppliers-reg(New drug policy 2009) Previous letterinvoice ref Sl No Drug Code Drug name

Manufacturing date Expiry date

Supplier address

B a t c h n o

The above items of PO nodated was drawn by the Drug Inspector (Place) on (______________date) as a statutory sampling and declared ldquoNot of Standard

59

Qualityrdquo on -(______________date) by the Government Analyst for the following reasons

- ldquoThe product sample do not confirm to IP specification for (Drug codename with respect to the content of drugrdquo

- ldquoThe product has already been blacklisted by TNMSC on -(______________date) for the failure of (quantity) of batches of drug codenamerdquo

As per the clause of the te nde r d oc um e nt ldquo I f the sa mple s d o not c onf o r m to statutory standardsthe tenderer will be liable for relevant action under the existing laws and the entire stock in such batch should be taken back by the tenderer within a period of 30 days o f t h e r e c e i p t o f t h e l e t t e r f r o m t h e v e n u e

The stock shall be taken back at the expenses of the tendererthe Procurement Authority have the right to destroy such Not of Standard Quality if the tenderer does not take back the goods within the stipulated time

The Procuring Authority will arrange to destroy the Not of Standard Quality drugs within 90 days after the expiry of 30 days mentioned above without further notice and shall also collect demurrage charges calculated at the rate of 2 per week on the value of the drugs rejected till such destructionrdquo

Hence we regret to inform you that you will have to take back the stocks available of the abovesaid batch at your own cost from the drug stores where you have supplied the above batch

Kindly acknowledge the receipt of this reference at once

P r o c u r e m e n t A u t h o r i t y Seal and Stamp

Copy to Ref No dated

1 ) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated13082010

To

Sub Frozen Drugs-ordered to return to the Suppliers-reg(New drug policy 2009) Previous letterinvoice ref

The following products which were earlier frozen have now been ordered to return to suppliers directly with permission from the State drug Authority In this regard the suppliers have been instructed to take back their failed batch from the drug store of the stores Hence you are now instructed to return the following failed batches to the suppliers by obtaining proper authorization letter and acknowledgements from them

60

Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

Kindly acknowledge the receipt of this reference at once

Procurement Authority Seal and Stamp

Copy to

Ref No dated 2) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated14092010

To

Sub Frozen Drugs-ordered to return to the Suppliers- for issue of gate pass after verification reg(New drug policy 2009) Previous letterinvoice ref

The following products which were earlier frozen have now been released Hence they may be issued Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

Kindly acknowledge the receipt of this reference at once

Procurement Authority Seal and Stamp

Copy to

61

Ref No dated 3) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated

To

Sub Stop instruction-reg(New drug policy 2009) Previous letterinvoice ref

Until further instructions stop issue all the batches of the following item Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

You must intimate the available stock in the stores of the said batch Number to the Procurement Authority immediately Also retrieve quantity if already issued

Procurement Authority Seal and Stamp

Copy to

Ref No dated 4) HOD Procurement Office of

62

Appendix II Material handling in drug stores

Rack approx rates and dimensions

S No

Item Description UOM Approx Rate

1 MEDIUM DUTY RACK SIZE 2900 H X 3090 W X 800 D IN MM (AS PER SPECIFICATION)

Each 2499800

2 MEDIUM DUTY RACK ADD ON UNIT FOR SIZE OF SR NO2

Each 2243100

To locate a Box no 3 Rack no 14 in row3

SAMPLE OF RACK no Bin numbering -------------- S a y R K 1 4 R o w 3 B o x 1 6

SAMPLE LAYOUT of RACKS in a Drug Stores

63

Sample of another warehouse of distribution warehouse system

64

65

Slotted Angle racks with bin cards

66

Plastic Pallets

Plastic pallets ar e l i g h t w e i g h t l o w- c ost and exceed industry standards for strength and durability

NOTE A pallet has bottom deckboards (see sketch) A skid does not have bottom

67

deckboards

Battery Operated Stacker

Electric Stacker Ehh (Manual Push Type) - Manual drive - Lifting electrically with Battery 12 V 88 Ah - For loading and un-loading of trucks - Battery and loading device built - in - Battery charge gauge and charging current gauge Simple and Easy Operation - Lifting and Lowering electrically direct on steering arm - Pulling and pushing through steering arm - Electrically operated relief valve on hydraulic aggregate Safe Operation - Emergency Off Switch - Constant lowering speed - Protection through lowering brake valve - Overload protection through overload brake valve - Load chains covered preventing pinching threat - Electrically interlocking during loading process - Secured battery compartment opens upwardly - Stable buffering of the steering arm in upright position - In accordance with EWG Guidelines 89 240 - In accordance with VBG 12b Prevention of Accidents

Pallet Truck [ Top ]

68

----------------------------------------------------------------------------------------------------------------------------

For Transport Of All Goods On Pallets Safe and Easy Operation - through single hand operation Lifting moving

lowering with steering handle - neutral position of the hydraulic possible - overload pressure relief valve Long Service Life - robust co n s t r u c t i o n

- special hardened axles - hardened chromium plated ram - maintenance free Easy Maneuverability - through rubber steering rollers - nylon fork rollers

A h a n d t r o l l e y

69

Trolley with plastic bins for several items del ivery

70

Digital Weighing balances

Balances amp Scales EF Seriers Precision Electronic Balance

71

1

Ice lined Refrigerators

600 litres refrigrator

72

Walk in cooler

vacuum cleaner

73

Annexure ndash I Loss- Procedure for Reporting

1 The exact nature of the defalcation 2 The full extent of loss 3 The actual period covered by the defalcation 4 The defects in the negle c t o f r u le s by w hic h the loss was rendered possible

and circumstances which facilitated the defalcation 5 The names of the officials held personally or technically directly or

indirectly and wholly or partially responsible for the irregularity c o m m i t t e d i n t h e c a s e

6 Whether the c a s e a s b e e n J u d i c i a l l y t r i e d i n a c o u r t o r n o t i f s o c o p i e s ( i n duplicate) of the Judgment may please be furnished Copy of police report may also be furnished

7 The remedial measures adopted as safeguards against the losses hereafter 8 The prospects of re covery of the loss and he action taken to effect

recovery together with the amount recovered 9 Head of Account to which the Loss is debitable may be informed

Signature of Head of Office with seal

NoteA copy of this report is to be sent to AGMPThis is as per M P Finance Code Vol I

28

STORAGE AND STOCK MANAGEMENT

29

Foreword

The New Drug Policy 2009 is being implemented in the State of Madhya Pradesh

In order to have a proper procedure for Storage maintenance and expiry management of the drugs it is necessary to follow Good Storage Practices with Standard Modules for pharmacistStore keepers

Proper guidelines on Storage Practices can lead to better Stores and inventory upkeep with medicines being properly stored in racks with proper cleanliness and hygiene

This is a step towards storage maintenance and expiry management at the various stores in the state Looking forward to see that the heads of all health facilities take benefit from this module

D ir e c t o r M e d i c a l S e r v i c e s

30

INDEX

Sr No P a r t i c u l a r s P a g e

1 S T O R A G E A N D S T O C K M A N A G E M E N T 4

1 Quarantine and checking of stocks 11 Quarantine area 12 Checks to be carried out on new stocks

2 S t o r a g e 21 Need for proper storage 22 Different patterns of storage 23 Different means of storage 24 Temperatureclimatic conditions 25 Special storage of supplies 26 Storage and stability of medicines

3 Stock Control and Expiry Monitoring 31 Stock control 32 Stock rotation and expi r y m o n i t o r i n g

4 Other aspects of storage 41 Design of a storage area 42 Cleaning and maintenance 43 Product recalls 44 Returned goods

2 A p p e n d i x 1 Templates of letters for use if found not of Standard Quality [Frozen and expired goods ]

Frozen Drugs-ordered to return to the Suppliers-reg(New drug policy 2009)

Frozen Drugs-ordered to return to the Suppliers- for issue of gate pass after verification reg(New drug policy 2009) Stop instruction-reg(New drug policy

2009) Appendix II Material handling in drug stores

31

3 PROCUREMENT ndash Government Order Relating to

the Management of Stores

(Reproduced for reference material on basic

procedure in decentralized system followed by

Health facilities in 1977)

54

F L O W C H A R T S f o r a BI R D S E Y E V I E W o f

P R O C U R E M E N T

5 5

ACQUISITION OF STORES 6 1

PLACING OF ORDERS 6 2

RECEIPT OF STORES 6 2

CUSTODY 6 3

ISSUE OF STORES Maintenance of Stock Books

6 3

PROCEDURE OF INDENTING FOR WARD amp OTHER SECTIONS OF THE INSTITUTION

6 4

HOW OFTEN TO INDENT 6 5

EMERGENT INDENT 6 5

HOW TO INDENT 6 5

KEEPING OF RECORDS IN WARDS A N D S E C T I O N S

6 6

ACCOUNTABILITY OF DRUGS BROUGHT BY THE PATIENT OR RECEIVED IN DON A T I O N BY T H E WARDSECTION _IN - CHARGE

6 7

RESPONSIBILITY OF STORES AT VARIOUS LEVELS

6 7

DISTRIBUTION OF MEDICINES FROM OUTDOOR DEPARTMENT

6 7

LOSS BREAKAGE DAMAGE ETC 6 8

PROCEDURE FOR WRITING OFF STORES 6 9

DISPOSAL OF WRITTEN OFF ARTICLES 7 1

FORMATS TO BE USED 7 3 - 81

32

STORAGE AND STOCK MANAGEMENT The expiry periods of pharmaceutical products have meaning only if the products are stored under proper conditions otherwise products are likely to lose their potency before the actual date of expiry

A pharmacist is a vital link in the distribution chain for pharmaceutical products The medicinal products remain for a long period during the distribution cycle at the wholesaler and at retail pharmacies It is therefore very important to maintain proper storage conditions in these units

Every community pharmacy however large or s mall needs to store and manage its medicine stocks effectively There must be systems to ensure

middot bullbull Secure storage middot bullbull Clean and correct environmental conditions during storage middot bullbull Accurate and effective record keeping middot bullbull Effective stock rotation and expiry monitoring middot bullbull Effective fire and theft prevention middot bullbull Effective rodent pest control

For easier un derstanding this module has been divided into the following sections

1 Quarantine and checking of stocks 11 Quarantine area 12 Checks to be carried out on new stocks

2 S t o r a g e 21 Need for proper storage 22 Different patterns of storage 23 Different means of storage 24 Temperatureclimatic conditions 25 Special storage of supplies 26 Storage and stability of medicines

3 Stock Control and Expiry Monitoring 31 Stock control 3 2 S t o c k r o t a t i o n a n d e x p i r y m o n i t o r i n g

4 Other aspects of s t o r a g e 41 Design of a storage area 42 Cleaning and maintenance 43 Product recalls 44 Returned goods

33

1 QUARANTINE AND CHECKING OF STOCKS

11 Quarantine Area D r u g S t o r e pharmacies receive stoc k s f r o m su pplie r s a c c or d ing to pur c h a se o r d e r s T he stock that is received must be visually checked for quality and quantity The stocks must be kept in a separate area until the checking is done to avoid intermixing with existing stock This necessitates the presence of a separate area within the pharmacy w h e r e i n t h e storage and other checking of stocks can be performed This area is called the QUARANTINE AREA This area should be marked and identified adequately to distinguish it from other areas

The area may be marked using different means 1 ) A s m a l l board saying Quarantine on a separate table used exclusively if it is in the middle 2) A board on the wall if the table on which the quarantine stock is placed is against the wall

middot Stock received from wholesalers should be immediately transferred t o t h e Quarantine Area

middot In the Quarantine area the stock may be stored on racks shelves or in cupboards to prevent ingress of moisture dirt and other contaminants

middot Regular stocks from the pharmacy should not be left kept in the quarantine area Special care has to be taken in case of refrigerated medicines supplied by the suppliers so tha t the y do not remain in the quarantine area for long periods of time They should be immediately checked on receipt and transferred to areas for refrigerated storage s o a s to maintain the cold chain bull

Advantages of having a separate Quarantine Area middot Avoids cross mixing of newly arrived stock from existing stock till it is checked middot Lays stress on checking the quality of the stock received middot S to ck checking ensures t hat defective andor expired goods do not enter the storage areas

34

bullbull

bullbull

12 Checks to be carried out on new stock

Unpacking and checking stock

Supplies received should be unpacked and checked in the quarantine area Staff doing the checks should be adequatel y trained in what they have to check when stock arrives

Checking should be seen not simply as counting the units received but as a part of the quality assurance system bullThis should include middot Visually inspecting the packaging middot Checking the integrity of containers middot V erifying the completeness and leg ibility of la b e ls ( a ppr o ve d dr u g name strength any special storage instructions and expiry date)

bull

The expiry dat e should be checked to ensure that there is adequate shelf life remaining

Supplies should be individually checked using a checklist 35

Checklists

36

The wholesaler supplying the product should be notified immediately in case of any discrepancies ( and the details should be recorded in a register) and sent in a written format to the supplier It should include middot Missing boxes or cartons middot O p en tampered boxes or cartons middot Missing supplies middot Differences in the actual quantity and the quantity shown on the packing middot Additional medicines that had not been ordered but have been supplied middot D a m a g e d b r o k e n o r p oor quality medicines middot Any other discrepancies

The purchase invoices are an important aspect to be considered The invoiced documents should be signed and filed for reference as per the Drugs and Cosmetics Act and retained for at least 3years

If the wholesaler supplies medicines as an emergency without a bill or against a delivery challan

middot The supplies should be checked for integrity and inspected for damage middot The details of supplies received should be recorded middot The supplier should be asked t o send the bill as early as possible middot When the bill is received it should be checked against the details recorded and anomalies if any should be reported to the supplier

To keep a track of the received stock maintaining a S t o c k R e c o r d C a r d c a n b e very useful The entries in the stock record card can be made while checking the stock received STOCK BIN in the stores should have Stock record card

Maintaining a stock card for every product may not be very practical for a retail pharmacy however it could be maintained for costly medicines Nowadays it is much more practical and easier to maintain records using computers

The pharmacist should ensure that medicines manufacturedmarketed by a company are received only through an authorized distribution network of that company This is important to prevent spurious and counterfeit drugs from entering the pharmacy

37

2 STORAGE 21 The need for proper storage The storage of medicines and other products is an important requirement of Good Pharmacy Pr actice Appropriate storage of medicines is essential -

middot bullTo ensure that the potency is maintained middot bullTo prevent deteriorationspoilagedegradation middot bullTo ensuremaintain physical integrity

To ascertain that the quality and safety is maintained throughout their shelf life Storage requirements need to be considered on 2 aspects

a) Integrity of medicines Medicines should be stored in such a way so as to maintain their integrity and potency middot Maintain the right temperature required middot Protect from excessive humidity middot Keep medicines away from direct sunlight middot Protect from pests and rodents

b) Physical location middot Should be easy to locate middot Accessible middot Orderlysystematically placed

2 2 D i f f e r e n t p a t t e r n s o f s t o r a g e The pharmacist could follow any of the different patterns of storage The pattern of stora ge should be selected in such a way that it facilitates speedy and efficient dispensing of medicines

The pattern of storage could vary with each pharmacy experience usual practiceroutine of staff and the person-in charge and also depending on space av ailable turnover etc (i) The medicines could be stored c o m p a n y w i s e ie the medicines manufactured by one company should be grouped together and kept in one place Within each company shelfshelves the medicines may be placed in alphabetical order for easy and quick placement and removal Also bottles tubes boxes etc may be segregated within that shelf

38

(ii) The medicines may also be stored in a lphabe t ic al o r de r ie they are placed in order from left to right based on their name The first letter of the name is used to g r o u p t h e m e d i c i n e s t o g e t h e r a n d k e e p t h e m i n o n e l o c a t i o n I n s o m e p h a r m a c i e s a l l t h e strip packing are placed in drawers or boxes in alphabetical order each box or drawer containing strips of one particular alphabet This system ensures that the strips always remain e n c l o s e d i n t h e b o x e s d r a w e r s a n d a r e n o t e x p o s e d t o d u s t T h e d i s a d v a n t a g e i s that it might lead to mix -u p o f strips in the same drawer and it may cause a problem incase of similar looking strips in which case a wrong medicine may be dispensed Secondly cut strips lying around in the drawer may lose their identity if the batch n u m b e r andor expiry date is not seen on the cut portion of the strip

39

(iii) The medicines may be stored according to their therapeutic class ( e g a n t i b i o t i c s anti asthmatics or anti hypertensives) ie the medicines are kept together based on their pharmacological or therapeutic action

(iv) The medicines may be stockedsegregated according to dosage forms eg l i q u i d s (bottles) solid oral dosage forms eye drops rotacaps ointments etc all stored on separate shelves

Always Remember I Storage of prescription medicines should preferably be separate from OTC medicines OTC medicines especially those that a r e a d v e r t i s e d m a y b e d i s p l a y e d f o r c l i e n t s t o select or to ask questions about [OTC-O v e r t h e c o u n t e r ] II Storage according to temperatures is a must no matter which pattern of storage is followed Also within a particular storage area segregated storage may be maintained In a refrigerator for example medicines may be stored in trays racks and the freezer according to the temperature required

40

Whatever pattern of storage is selected all the personnel should ensure that middot The stocks are stored in an orderly manner middot The medicines are kept back in the same place from where they were removed middot All medicines are arranged neatly once in a while

middot The personnel should be careful while storing the medicines middot They should not throw the medicines haphazardly 23 Different means of storage

middot Within each temperature and security zone medicines must be stored so that they are easily accessible and protected against damage

middot Basic means of storage include shelves racks and drawers middot To prevent dust from entering the shelvesracks it is ideal to have glass

shutterssliding glass doors This can however be disadvantageous because accessibilityspeed is hampered in removing a product from the shelf because the glassshuttersliding glass has to be

41

opened m o v e d e v e r y t i m e a p r o d u c t h a s t o b e p i c k e d u p U s e o f a i r c o n d i t i o n e r s f o r t h e p h arm acy with a closed door at the e n t r a n c e o r a n a i r c u r t a i n c a n r e d u c e t h e d u s t problem In such cases the shelvesracks may be left o p e n

bull

middot Direct storage of cartons on the floor should be avoided because besides being an unhealthy practice the contents may also be damaged by moisture bull

middot Store medicines preferably in shelves with glass shutters for visibility middot Closed shelves further prevent dust from going in especially in India where most

pharmacies are located along busy roads middot Some medicines have to be refrigerated or stored in a cool or cold place Having a

refrigerator or two (as per the need of the pharmacy) is essential to store suc h medicines at temperatures mentioned on the label bull

42

Refrigeration middot All cold chain equipment should meet required standards middot Improvement in refrigeration technology has provided frost -free refrigerators

Pharmacists should opt for frost-free refrigerators as they are easy to maintain and protect printed packaging materials Conventional refrigerators may cause water falling from trays below the freezer on medicines stored in the refrigerator thus causing soggy labels

middot bull Frost-free refrigerators also provide separate and large compartments for the freezer portion (required for storing medicines needing sub-z e r o t e m p e r a t u r e ) and the main storage area with separate doors so that opening one door does not disturb the storage temperature in the other compartment

Care should be taken to keep the refrigerator on 24 hours a day It should not be switched off after working hours It is advisable to have an inverter connected to the refrigerator so that the refrigerator re mains working even when there is a power outage

middot The refrigerator door should be closed tightly middot The refrigerator door should not be left open for too long middot Space should be left between medicines stored in a refrigerator to allow air to

circulate middot The ref rigerator should be placed about an arms length away from the wall

This will increase air circulation thus not affecting the cooling within the refrigerator

middot Vaccines should not be stored on refrigerator door shelves as they are exposed to warmer temperatures each time the door is opened Vaccines should always be stored on the middle shelves of the refrigerator

middot Refrigerated medicines should not be left out of the refrigerator for more than a few minutes

43

middot Consumable products like juices energy drinks e t c s h o u l d n o t b e s t o r e d a l o n g with medicines in refrigerators If required they may be kept in a separate refrigerator

middot An adequate number of refrigerators should be planned to store the entire stocks requiring refrigerated storage

middot Adequate procedures should be followed for defrosting cleaning and maintenance of refrigerators

middot Icefreeze packs should be kept in the freezer compartment so that they can be used for transporting cold temperature medicines The packs can be given to clients along with the medicines requiring cold temperature storage so that the temperature is maintained till the client reaches home and can then put the medicines in a refrigerator) Freezer packs can also be used to keep medicines temporarily in case there is a power outage or refrigerator breakdown

Activity

Prepare a SOP (Standard operating procedure chart) for cleaning a refrigerator Discuss it with your staff finalize its maintenance once a month through AMC -A n n u a l Maintenance contract CMC - Comprehensive maintenance contract and put it up on the pharmacy refrigerator Put the Purchase Order details name of manufacturer Phone of Service Engineer and a register to login the Machine service and down timeService reports may be maintained properly

Refrigerator monitoring and maintenance

middot bullIt is important to carry out routine monitoring and maintenance of the refrigerators and to organize an effective repair system

middot bullThe temperature in the refrigerator must be monitored and recorded routinely at least once a day

middot Any breakdown must be reco rded including the period during which the medicines were exposed to uncontrolled temperatures Medicines may then be kept or discarded depending on the problem guidelines or the manufacturers advice

middot Cold chain monitor cards and devices in or on packages that change color or otherwise alert staff to potential damage assist in monitoring (These are likely to be introduced in India soon)

middot It is essential to have a contingency plan in place before a refrigerator breaks down An arrangement can be made to move the contents to a private refrigerator elsewhere in the community or to obtain a regular supply of ice packs until the defect is rectified

Put filled water bottles in the bottom half of the refrigerator door in order to provide cooling in the refri g e r a t o r w h e n t h e r e i s a p o w e r o u t a g e T h i s m i g h t t a k e c a r e o f t h e temperature when there is no current for a couple of hours If the power outage is expected to last for several hours special arrangements such as an inverter UPS have to be made to keep the refrigerator constantly running in the absence of electricity middot Defrost the refrigerator in case of excessive ice formation and preferably at regular

intervals Keep a record of the same

44

2 4 T e m p e r a t u r e c l i m a t i c c o n d i t i o n s

i) Temperature control middot The medicines in a pharmacy need to be stored at appropriate temperatures to

maintain their stability middot An air-conditioned environment where temperature can be controlled is

recommended for pharmacies Air conditioning offers the option of setting the t e m p e rature as per requirements

middot bullIt is ideal to have an air conditioner to maintain the temperature below 25 C as most medicines require storage below this temperature Secondly this temperature is pleasing to both the staff and the visiting customers too

middot In the absence of an air conditioner circulating fans may be used middot This need is felt even more in certain parts of India where temperatures soar above 45

C and some areas where it falls to sub zero temperatures In such cases temperature maintenance is essential to prevent deterioration of medicines due to unnecessary exposure to drastic temperature fluctuations

middot This need is felt even more in certain parts of India where temperatures soar above 45 C and some areas where it falls to sub zero temperat u r e s I n s u c h c a s e s temperature maintenance is essential to prevent deterioration of medicines due to unnecessary exposure to drastic temperature fluctuations

i i ) Humidity or moisture control Moisture or humidity can adversely affect the stability of me dicines such as tablets capsules powders

45

Gelatin capsules become soft and swell on absorption of moisture The drug content of tablets may undergo surface hydrolysis The presence of moisture may encourage the growth of microbes It is therefore essential to control humidity

To reduce the effect of humidity the following suggestions may be followed -middot Open the windows to allow air circulation Use a fan to circulate fresh (outside) air middot In humid climate a dehumidifier is useful for preventing mo i s t u r e d a m a g e ( i n t h e absence of an air conditioner) middot For bulk containers of tabletscapsules do not keep the container open for a long time and replace the lid or closure immediately after taking out the required number of medicines for dispensing middot Do not allow the medicines to touch the floor or the walls The walls may be damp and may cause moisture absorption damaging the product

middot Calibrated thermometers and manometers can be used to detect temperature and humidity in the pharmacy

middot Periodici t y of checking the temperature should be fixed middot The climatic conditions should be recorded and documented middot Temperature charts should be available for ready reference

Documentation is one of the core activities for achieving and maintaining quality It is one of the most essential components of validation Temperatures in various areas

46

including refrigerators should be recorded at a predetermined periodicity usually daily at the hottest time of the day and such documents should be preserved i i i ) Storage conditions A number of storage conditions are mentioned on the labels of medicinal products These conditions have to be properly interpreted and appropriately complied with

According to the Drugs and Cosmetics Rules 1945

1 The term cool place means a place having a temperature between 10 C and 25 C

2 The term cold place means a place having a temperature not exceeding 8 C In case of storage conditions for specific products please refer to Schedule P The Drugs and Cosmetic Rules 1 9 4 5

The Indian Pharmacopoeia specifies the following storage conditions -

Wherever the condition for storage is not specified medicines may be stored under normal temperature In a country like India however where normal temperatures soar to h i gh temperatures it is recommended that medicines be stored in a cool place

Activity Prepare a list of the storage requirements mentioned on the label of about 20 products in your pharmacy and check if the temperature is maintained

47

25 Special Storage o f s u p p l i e s If the product has no special instructions normal storage conditions apply This means storage in dry clean w e l l -ventilated premises at temperatures of +15 C to +25 C or depending on the climate up to +30 C (WHO1990) Storage instructions are product specific Different brands of the same generic drug may have different storage requirements as they may have different packaging or formulations It is essential to follow the product manufacturers storage instructions to the maximum extent possible Less stable medicines must be stored in specific conditions to maintain their quality or potency

The following products require special storage facilities

middot Products that must be kept frozen (usually vaccines and sera) middot Products sensitive to h eat an d r e q uir in g r e f r ig e r a tio n ( +2 C to +8 C) middot Products that have reduced shelf life at uncontrolled room temperature and need

mechanical ventilation or air conditioning middot Flammable products that require separate fireproof premises middot Products prone to theft o r m i s u s e

Products needing storage in a controlled environment -

The usable shelf life of the following products may be reduced if stored at uncontrolled humidity or at room temperature in hot climates -

middot Some injectables (eg adrenaline) Most injectable preparations are less stable than solid oral forms (tablets and capsules) Injectable preparations in solution are particularly unstable Many injections must be protected from light as well as heat

middot Intravenous fluids (particularly if packed in p lastic containers) middot Some suppositories pessaries creams and ointments These products may melt at

temperatures greater than 30 C Once this happens it is not advisable to use them because the active ingredient in the formula may get unevenly distributed

middot Products containing rubber latex cellulose or some plastics Condoms most sterile disposable medical devices and surgical products such as syringes needles and catheters require protection from excessive humidity and strong light and heat Any o f these conditions may make products brittle stained amp unusable Sterility cannot be assumed if packaging is damaged

In hot climates these products should be stored in the coolest place possible preferably with air conditioning or air circulation fans

48

Products needing freezing or refrigeration-middot Vaccines blood products and many other medicines lose potency if kept even for a

brief period at temperatures outside the recommended range For these products the cold chain must be maintained at every stage of the distribution system

middot Freezing is as damaging as high temperatures for some products including injectable contraceptives ergometrine insulin adrenaline and the DPT DT TT and Hepatitis B vaccines Such products therefore sho uld not be allowed to freeze (not be kept in the freezer compartment)

middot Short periods at room temperature (during transportation or local distribution for instance) may be acceptable for many products (such as ergometrine a n d i n s u l i n ) e v e n t h o u g h s u c h e x posure can to some extent reduce shelf life Other items such as vaccines should always be transported in cold boxes

Storage of insulin injections-

middot Insulin should always be stored in a refrigerator at the recommended temperature of 2 -8 C

middot Insulin should not be kept in the freezer compartment of the refrigerator middot Insulin should ideally be stored horizontally middot It should not be exposed to sunlight or excessive heat middot Insulin suspensions should not be used if the suspension cannot be properly

resuspended due to cake or clump formationbull

Controlled drugs -Narcotics (for example Pethidine injection morphine preparations) and other specified drugs that may be abused are governed by special legislation and regulations The following security measures are suggested in the pharmacy -middot A safe or reinforced double locked cabinet fitted with a light (preferably with a red

bulb) that comes on when the door is opened

49

middot A special register recording details of each receipt or issue with 2 signatures physi cal counting of medicines after each entry and signatures at handover takeover

middot Independent audit (by supervisors and drug inspectors)

Products prone to theft abuse or misuse -

Some medicinesproducts are particularly prone to theft abuse or misuse These include expensive medicines (eg insulin) certain antibiotics and products prone to abuse or misuse like psychotropics etc

Such medicinesproducts should be stored adequately They require stricter record keeping and more frequent stock taki ng than others Periodic audits should be carried out to check for consumption against actual recorded use (registers prescription records stock records etc) to expose any theft or misuse bull26 Storage and stability of medicines Medicines are not stab le indefinitely They are stable for a specific period of time sometimes for a brief period Poor storage conditions accelerate the drug degradation (decomposition) Temperature light and moisture are the most important contributing factors for drug instability It is important to identify and be aware of the potential for instability There is a need to comply with storage requirements to ensure quality medicines for patients It is also important to offer advice to patients too about appropriate storage o f medicines at home The dispensing label should state the storage condition required and be backed up by a verbal reminder especially where special storage is required bull

50

In case stability and storage problems are seen with formulations they should be reported immediately to the representative of the manufacturer and taken out of circulation till the stability problems have been resolved

The pharmacist can easily detect stability problems when products show change in appearance color odor settling of the product contents breaking of emulsions melting of creams oozing of contents from the containers and any such physical changes

3 STOCK CONTROL AND EXPIRY MONITORING 3 1 S t o c k C o n t r o l For economic reasons pharmacists do not like to have stock on their shelves for long periods of time The aim should always be to keep stock at a level that will just meet demand Normally most manufactured medicines have a long shelf life Even then it is essential that there is efficient stock rot ation so that the older stock is used first It is also a good practice to check the expiry date as an integral part of the dispensing process When short shelf life products are involved stock levels may have to be modified to prevent medicines regularl y expiring on the shelves

32 Stock rotation and expiry monitoring In order to avoid accumulation of expired and obsolete stock medicines should be stored and issued according to the following guidelines -middot The stock control system must record the ex p i r y d a t e a n d t h e d a t e o f r e c e i p t middot Stock must be stored so that earliest expiring batches are picked and issued first middot The First In First Out (FIFO) system - In this system the stock which is received

first is sold first This system however may not be useful for pharmacies because most of the stocks carry an expiry date For pharmacies the FEFO system is more practical

51

middot The First Expiry First Out (FEFO) system - In this system the stock having an earlier expiry is sold first The stock with longer shelf life should be placed farthest to the back (or at the bottom in case o f sta c k e d b oxe s) T h is is pa r tic u la r ly impor ta n t with products that have short shelf lives such as vaccines some vitamins antibiotics etc and reduces losses due to expiry

middot E x p i r y dates should be noted on the stock record upon receipt Stock nearing expiry should not be accepted unless it can be used before expiry

Computerization and expiry monitoring In the pharmacy computerization facilitates both checking stocks and expiry mo nitoring and helps-bullbullKeeping a check on products nearing expiry bullbullKeeping a check on non- moving and slow moving products bullbullTo facilitate the removal of medicines nearing expiry from shelves in time to send them back to the wholesaler or supplier

Periodic checking for expiry The expiry date for medicinal products is a critical aspect in pharmaceutical dispensing and due importance should be given to it Periodic checking for expiry of medicines will ensure that the patient will never receive products that have crossed their expiry date During periodical checking of expiry the personnel involved should remove medicines that are nearing expiry bullbullIn -house threshold periods should be set and followed for retrieval of such medicines from the shelves bullbullSuch medicines should be stored separately These should either be dispensed immediately (thus ensuring that they are used before the expiry date) o r t h e y s h o u l d b e returned to the suppliers bullbullA separate area should be designated (cupboard or shelf)marked[FROZEN ZONE] which is adequately marked EXPIRED GOODS- NOT FOR SALE to store all expired stocks FROZEN ZONE

52

Remember Expired medicines are a NATIONAL WASTE So stock only what you can sell Avoid expiries save precious medicines for the nation

Treatment and disposing of expired medicines bullbullProcedures need to be in place for the treatment of expired medicines bullbullThe expired medicines need to be collected and be sent back to the supplier or company for appropriate disposal bullbullRecords must be maintained for expired medicines and how they are disposed off bullbullIn case of medicines that are not returnable to suppliers procedures for disposal need to be followed by the pharmacy in conjunction with the FDA The following procedure can be followed if medicines cannot be returned to suppliers ( T h e b a s i c p h i l o s o p h y of appropriate disposal is to prevent their re- circulation and use) bullbullC u t t h e c o n t ainer in such a manner that the label is also cut In case of tablets and c a p s u l e s d e s t r o y them by disposing them in a bucket of water bullbullUse landfill procedures (deep burial into the ground as per stipulations of Medical Waste Disposal Act prevalent in the respective state) bullbullPour the liquids into the sink and wash away with sufficient quantity of water bullbullKeep a record of such disposal with full details of medicines destroyed Although these measures are usually adopted care has to be taken with such tr e a t m e n t a s studies have shown that flushing of medicines has resulted in tracessmall quantities of medicines being found in waterways and groundwater having potential health and environmental effects

4 O T H E R A S P E C T S 41 Design of storage areas The following important factors need to be considered in design of storage areas -middot The retail outlets in hot areas in summers should be air-conditioned Similarly in

a r e a s o f e x t r e m e c o l d t h e p r e m i s e s w o u l d r e q u i r e w a r m i n g e s p e c i a l l y i n w i n t e r s t o maintain cool temperatures The placement of air -conditioners and heating devices should be such that medicines are not directly exposed to the cold or heat

middot Due consideration should be given to storage requirements of formulations while designing shelves and cupboards in retail outlets Sufficient shelf height should be provided so that all liquid products can be stored vertically As far as possible the shelves should be covered with glass panels to protect medicines from dust and p r e v e n t r a p i d f l u c t u a t i o n s i n temperature

middot Medicines should be stored according to the storage instructions on the labels bullIt is ideal to have a door at the pharmacy entrance to prevent dust from coming in as well as reduceprevent cooled air from going out This may not however be considered feasiblepracticable by many pharmacy owners for fear that clients may not enter the pharmacy because the door may act as a barrier An air curtain is a good alternative to a door

middot There should be minimal direct sunlight falling on the products Particular consideration should be given to premises directly facing the sun

middot bullThe arrangement of lighting in the interior of the premises should also be in a manner that the lights are not focused on the products It has been shown that light causes not only chemical damage but also can catalyze physical changes like moisture uptak e by the products Care should be taken to ensure that only diffused light falls on them

53

middot As far as possible provision should be made for a temperature and humidity indicator device in a pharmacy These devices are now easily available

middot Stability studies o f m e d i c i n e s p a c k e d i n b l i s t e r s h a v e r e v e a l e d t h a t i f t h e s e a r e exposed to light they tend to absorb moisture It is therefore necessary to store them in suitable cartons so that the blisters are not exposed to light Pharmacists should do this even if the manufacturer has not provided cartons

middot Light and temperature sensitive products should not be stored on counters where the light is intense or direct and there is no protection from temperature and humidity

42 Cleaning and maintenance i) Cleaning of storage areas

The storage areas of the pharmacy should be cleaned periodically and cleanliness should be maintained at all times The Standard Operating Procedure for cleaning should be designed and followed accordingly Schedules for cleanups should be laid down and adequate cleaning equipment should be made available

Tips for maintaining cleanliness middot Provide clean pieces of cloth for wiping at various locations in the pharmacy

Replace with clean cloth at regular intervals middot Keep separate pieces of cloth for floors shelves and medicines middot Use a disinfectant andor soap solution to clean floors middot Ensure removal of dust and prevent accumulation of dirt middot Ensure removal of cobwebs middot Use a vacuum cleaner for cleaning areas not easily reachable middot T a k e c a r e t h at breakages are handled and cleared effectively middot Observe the factors leading to waste generation in the pharmacy and take appropriate

measures to tackle the problem middot Record all cleaning procedures performed and maintain all the documents required

For ex a m p l e -bullbullThe floor of the pharmacy may be swept with a broom and swabbed with soap water every morning bullbullThe floor may be swabbed with a disinfectant every week bullbullThe entire premises including shelves and cupboards may be cleaned with a cloth (to remove dust and to check for medicines approaching expiry date or expired medicines) every three months bullbullAll the steps followed should be r e c o r d e d

The floor shelves drawers have to be cleaned and a check should be kept on dust cobwebs spillages due to breakage etc It is therefore essential to have SOPs for cleaning laying down cleaning frequencies allotting responsibilities and maintaining a daily record in the logbook to document all these activities

54

While cleaning dust settled on dosage forms like bottles tubes etc should be removed Before dispensing the products should also be wiped to remove any dust settled during storage

For refrigerators bullbullDefrosting and cleaning should be done at regular intervals bullbullSwitch off the refrigerator while cleaning bullbullCleaning should be done quickly and stocks put back immediately

i i ) Pest control Pests are a serious problem in India where insects reptiles and rodents (eg cockroaches l i z a r d s r a t s s i l v e r f i s h (Deemak - in Hindi ) etc) may find access to the pharmacy storage areas Insects like ants and borer ants may often attack wood in the pharmacy causing d am ag e to shelves cupboardsPest c ontr o l in a p h a r m a c y c a n b e a d i f f i c u l t t a s k b u t t o avoid possible contamination and physical damage to stock it is necessary to keep pests out of the pharmacy premisesPest control measures should be implemented with proper p r e c a u t i o n s t a k i n g u t m o s t c a r e t o a v o i d contamination of medicines

55

Th e following pest control measures c a n be ta ke n f r om tim e to tim e -bullbullRat bait and traps can be placed at various locations bullbullInsecticutors can be used on a permanent basis bullbullInsecticidal sprays and repellants can be used from time to time

i i i ) Fire precautions

Combustible trash such as cartons boxes and other packing waste must not be allowed to accumulate in the store Waste should be deposited in appropriate waste bins and be d i s p o s e d o f f o n a d a i l y b a s i s

F i re detection and fire fighting equipment must be maintained and regularly inspected The pharmacy personnel should receive adequate training in fire fighting techniques and emergency actionFire prevention measures should include a prominently displayed ldquoNoSmokingrdquo sign careful handling and disposal of combustible waste materials and checking of electrical connections at regular intervals

iv) Security middot Doors shutters of the pharmacy should be strong and be fitted with secure locks middot Counters should be designed so that unauthorized personnelclients do not have

access to areas where prescription medicines are stored Access to such areas should be restricted to the pharmacy staff

middot All the pharmacy staff handling supplies should be accountable for their ac t i o n s

56

middot bullSpecial care must be taken in case of Schedule X and manufactured drugs (under NDPS Act) Such medicines should be kept under lock and key and the key should be kept with the Chief Pharmacist or i n h i s a b s e n c e t h e s e n i o r p h a r m a c i s t

v) Breakagespillage and damaged product Products that have been damagedspoiled during storage and handling spillages and broken glassware should be disposed off according to procedures laid down by the pharmacy Broken and damaged products s h o u l d b e p l a c e d i n a segregated area to be returned to the supplier

vi) Inspection Senior staff should inspect all pharmacy areas regularly The shelves and drawers should b e c h e c k e d d a i l y f o r signs of pests and dust Ceiling and walls should be checked for dirt and cobwebs Stock should be checked on a regular basis for deterioration due to climatic conditions

43 Product recalls Products found to be defective should be quickly recalled (withdrawn from the market) The instructions are generally issued either by the manufacturer or the regulatory agency The level of recall is determined by both the degree of risk and the extent of distribution of the product and in India is mainly directed at the distribution chain

On receiving the details of the defective substandard spurious batchbatches of a medicine to be recalled from the manufacturer or the stockist or the FDA the pharmacy should immediately check if the particular b a t c h i s i n s t o c k a n d i f s o s u s p e n d i t s s a l e immediately

Similarly if the regulatory authority in the country bans a particular medicine or FDC the pharmacy should immediately check and remove all the different brands of that particular medicine under consideration

The details of medicines and their batches to be recalled should be available in the q u a r a n t i n e a r e a w h e r e stocks are received and checked This is to ensure that such medicines do not come into the pharmacy

middot The pharmacy should develop SOPs for recall of medicines middot The pharmacy staff should be immediately informed about such medicines and

the details should be displayed in writing in a prominent place in the pharmacy middot Rapid action helps avoid unnecessary exposure to such medicines once the

problem has been d e t e c t e d middot The progress of the recall procedure in the pharmacy should be monitored every

few days to ensure complete compliance middot All stocks of the recalled products should be stored separately from the saleable

stock These can be stored in the expiry cupboard segregated from the expired goods and be appropriately labeled ldquoRecal l e d G o o d s - Not for Salerdquo

The supplier should be notified and asked to replace defective products middot All the details of the procedures followed should be duly recorded in a Recall

Register maintained specially for the purpose The register should include d etails such as -middot Date of the recall middot Nam e of the product

57

bullbull

middot Details of the product (name of manufacturer batch number expiry date) middot Nu m b er of units purchased sold a n d sto c k in ha nd middot Reason for recall middot Nam e of the supplier to whom produc ts w e r e returned along with the date and quantity middot Name and signature of the designated personnel carrying out the recall procedure and recording details middot Name and signature of the chief pharmacist verifying the recall procedures and recording details 4 4 Returned medicines

Medicines may be returned to the pharmacy by clients due to the following reasons -bull

bullbull Unused medicines bullbull Course not completed bullbull Therapy changed by doctor bullbull Side effects experienced by patient bull

bullbull DamagedDefective medicines bullbull Missing or defaced label bullbull Missing tablets in a stripblister bullbull Leakage in bottles bullbull Leakage in strips bull

bullbull Expired medicines

Appropriate SOPs should be framed and followed for their acceptancerefusal and disposal middot bull For unused medicines returned by clients the p harmacy personnel should verify

that these were purchased from their pharmacy They should then be checked for integrity of the packing the dosage form and the expiry date and verified with the client whether they were stored in appropriate conditions This again is at the discretion of each pharmacy

middot The damageddefective medicines returned to the pharmacy should be taken back and stored separately Existing stock of the same product should be checked for similar defects

middot Expired medicines should be accepted from clients at the discretion of the pharmacist and be immediately shifted to the expired goods cupboard These can be stored segregated from the pharmacys own expired goods and be appropriately labelled ldquoExpired Goods returned by clients- Not For Salerdquo

It is advisable not to accept returned medicines requiring cold chain storage (refrigeration) because it cannot be ensured that the cold chain was maintained when the medicines were in the hands of the patientclient middot Appropriate adjustments in t he stocks should be made for medicines

returnedexchanged to update the inventory middot The medicines should then be returned to the respective shelves middot A lsquoReturned Goodsrsquo register needs to be maintained to record all details of returned

medicines

R egister should include such details as-

58

middot N a m e o f t h e p a t i e n t middot Nam e of the product and quantity r e tu r n e d middot Product details such as the batch number and expiry date middot Condition in which received middot Reason for returning products middot Compensatory measures taken wi t h r e s p e c t t o c l i e n t middot Action taken with respect to product middot Name and signature of the personnel accepting the returned medicines and recording details middot Name and signature of the chief pharmacist verifying the recorded details

What the pharmacist would have learnt from this module The storage of medicines is a critical factor in the distribution cycle bullbull Stocks received by the pharmacy should be quarantined in a separate area and necessary checks s h o u ld be performed to ascertain the qua lity a nd quantity of stocks received bullbull Whatever pattern and means of storage used the products should be stored so as to maintain their potency and integrity bullbull Storage conditions should be monitored and maintained on a regular basis bullbull Optimum stock levels should be maintained and regularly monitored for expiry bullbull The design of storage areas should facilitate appropriate storage of medicines bullbull Cleanliness should be maintained in the pharmacy bullbull Adequate measures should be taken in case of returned medicines and recalled products

Optimum storage of medicines is mandatory whether at the distribution stage at the pharmacy or ultimately within the homes of patients The pharmacist has an important r o l e t o p l a y i n t h e s t o r a g e o f m e d i c i n e s i n m a i n t a i n i n g d r u g p o t ency and efficacy and thus facilitating optimum therapeutic benefits Good Pharmacy Practice - IPA -CDSCO - WHO Appendix I Quality Assurance Templates of letters for use if found not of Standard Quality [Frozen and expired goods ]

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated To Name of the Supplier with address

Sub Not of Standard Quality GoMP-Supply of Drugs and medicines-(Codename) Return of Stocks to the Suppliers-reg(New drug policy 2009) Previous letterinvoice ref Sl No Drug Code Drug name

Manufacturing date Expiry date

Supplier address

B a t c h n o

The above items of PO nodated was drawn by the Drug Inspector (Place) on (______________date) as a statutory sampling and declared ldquoNot of Standard

59

Qualityrdquo on -(______________date) by the Government Analyst for the following reasons

- ldquoThe product sample do not confirm to IP specification for (Drug codename with respect to the content of drugrdquo

- ldquoThe product has already been blacklisted by TNMSC on -(______________date) for the failure of (quantity) of batches of drug codenamerdquo

As per the clause of the te nde r d oc um e nt ldquo I f the sa mple s d o not c onf o r m to statutory standardsthe tenderer will be liable for relevant action under the existing laws and the entire stock in such batch should be taken back by the tenderer within a period of 30 days o f t h e r e c e i p t o f t h e l e t t e r f r o m t h e v e n u e

The stock shall be taken back at the expenses of the tendererthe Procurement Authority have the right to destroy such Not of Standard Quality if the tenderer does not take back the goods within the stipulated time

The Procuring Authority will arrange to destroy the Not of Standard Quality drugs within 90 days after the expiry of 30 days mentioned above without further notice and shall also collect demurrage charges calculated at the rate of 2 per week on the value of the drugs rejected till such destructionrdquo

Hence we regret to inform you that you will have to take back the stocks available of the abovesaid batch at your own cost from the drug stores where you have supplied the above batch

Kindly acknowledge the receipt of this reference at once

P r o c u r e m e n t A u t h o r i t y Seal and Stamp

Copy to Ref No dated

1 ) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated13082010

To

Sub Frozen Drugs-ordered to return to the Suppliers-reg(New drug policy 2009) Previous letterinvoice ref

The following products which were earlier frozen have now been ordered to return to suppliers directly with permission from the State drug Authority In this regard the suppliers have been instructed to take back their failed batch from the drug store of the stores Hence you are now instructed to return the following failed batches to the suppliers by obtaining proper authorization letter and acknowledgements from them

60

Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

Kindly acknowledge the receipt of this reference at once

Procurement Authority Seal and Stamp

Copy to

Ref No dated 2) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated14092010

To

Sub Frozen Drugs-ordered to return to the Suppliers- for issue of gate pass after verification reg(New drug policy 2009) Previous letterinvoice ref

The following products which were earlier frozen have now been released Hence they may be issued Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

Kindly acknowledge the receipt of this reference at once

Procurement Authority Seal and Stamp

Copy to

61

Ref No dated 3) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated

To

Sub Stop instruction-reg(New drug policy 2009) Previous letterinvoice ref

Until further instructions stop issue all the batches of the following item Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

You must intimate the available stock in the stores of the said batch Number to the Procurement Authority immediately Also retrieve quantity if already issued

Procurement Authority Seal and Stamp

Copy to

Ref No dated 4) HOD Procurement Office of

62

Appendix II Material handling in drug stores

Rack approx rates and dimensions

S No

Item Description UOM Approx Rate

1 MEDIUM DUTY RACK SIZE 2900 H X 3090 W X 800 D IN MM (AS PER SPECIFICATION)

Each 2499800

2 MEDIUM DUTY RACK ADD ON UNIT FOR SIZE OF SR NO2

Each 2243100

To locate a Box no 3 Rack no 14 in row3

SAMPLE OF RACK no Bin numbering -------------- S a y R K 1 4 R o w 3 B o x 1 6

SAMPLE LAYOUT of RACKS in a Drug Stores

63

Sample of another warehouse of distribution warehouse system

64

65

Slotted Angle racks with bin cards

66

Plastic Pallets

Plastic pallets ar e l i g h t w e i g h t l o w- c ost and exceed industry standards for strength and durability

NOTE A pallet has bottom deckboards (see sketch) A skid does not have bottom

67

deckboards

Battery Operated Stacker

Electric Stacker Ehh (Manual Push Type) - Manual drive - Lifting electrically with Battery 12 V 88 Ah - For loading and un-loading of trucks - Battery and loading device built - in - Battery charge gauge and charging current gauge Simple and Easy Operation - Lifting and Lowering electrically direct on steering arm - Pulling and pushing through steering arm - Electrically operated relief valve on hydraulic aggregate Safe Operation - Emergency Off Switch - Constant lowering speed - Protection through lowering brake valve - Overload protection through overload brake valve - Load chains covered preventing pinching threat - Electrically interlocking during loading process - Secured battery compartment opens upwardly - Stable buffering of the steering arm in upright position - In accordance with EWG Guidelines 89 240 - In accordance with VBG 12b Prevention of Accidents

Pallet Truck [ Top ]

68

----------------------------------------------------------------------------------------------------------------------------

For Transport Of All Goods On Pallets Safe and Easy Operation - through single hand operation Lifting moving

lowering with steering handle - neutral position of the hydraulic possible - overload pressure relief valve Long Service Life - robust co n s t r u c t i o n

- special hardened axles - hardened chromium plated ram - maintenance free Easy Maneuverability - through rubber steering rollers - nylon fork rollers

A h a n d t r o l l e y

69

Trolley with plastic bins for several items del ivery

70

Digital Weighing balances

Balances amp Scales EF Seriers Precision Electronic Balance

71

1

Ice lined Refrigerators

600 litres refrigrator

72

Walk in cooler

vacuum cleaner

73

STORAGE AND STOCK MANAGEMENT

29

Foreword

The New Drug Policy 2009 is being implemented in the State of Madhya Pradesh

In order to have a proper procedure for Storage maintenance and expiry management of the drugs it is necessary to follow Good Storage Practices with Standard Modules for pharmacistStore keepers

Proper guidelines on Storage Practices can lead to better Stores and inventory upkeep with medicines being properly stored in racks with proper cleanliness and hygiene

This is a step towards storage maintenance and expiry management at the various stores in the state Looking forward to see that the heads of all health facilities take benefit from this module

D ir e c t o r M e d i c a l S e r v i c e s

30

INDEX

Sr No P a r t i c u l a r s P a g e

1 S T O R A G E A N D S T O C K M A N A G E M E N T 4

1 Quarantine and checking of stocks 11 Quarantine area 12 Checks to be carried out on new stocks

2 S t o r a g e 21 Need for proper storage 22 Different patterns of storage 23 Different means of storage 24 Temperatureclimatic conditions 25 Special storage of supplies 26 Storage and stability of medicines

3 Stock Control and Expiry Monitoring 31 Stock control 32 Stock rotation and expi r y m o n i t o r i n g

4 Other aspects of storage 41 Design of a storage area 42 Cleaning and maintenance 43 Product recalls 44 Returned goods

2 A p p e n d i x 1 Templates of letters for use if found not of Standard Quality [Frozen and expired goods ]

Frozen Drugs-ordered to return to the Suppliers-reg(New drug policy 2009)

Frozen Drugs-ordered to return to the Suppliers- for issue of gate pass after verification reg(New drug policy 2009) Stop instruction-reg(New drug policy

2009) Appendix II Material handling in drug stores

31

3 PROCUREMENT ndash Government Order Relating to

the Management of Stores

(Reproduced for reference material on basic

procedure in decentralized system followed by

Health facilities in 1977)

54

F L O W C H A R T S f o r a BI R D S E Y E V I E W o f

P R O C U R E M E N T

5 5

ACQUISITION OF STORES 6 1

PLACING OF ORDERS 6 2

RECEIPT OF STORES 6 2

CUSTODY 6 3

ISSUE OF STORES Maintenance of Stock Books

6 3

PROCEDURE OF INDENTING FOR WARD amp OTHER SECTIONS OF THE INSTITUTION

6 4

HOW OFTEN TO INDENT 6 5

EMERGENT INDENT 6 5

HOW TO INDENT 6 5

KEEPING OF RECORDS IN WARDS A N D S E C T I O N S

6 6

ACCOUNTABILITY OF DRUGS BROUGHT BY THE PATIENT OR RECEIVED IN DON A T I O N BY T H E WARDSECTION _IN - CHARGE

6 7

RESPONSIBILITY OF STORES AT VARIOUS LEVELS

6 7

DISTRIBUTION OF MEDICINES FROM OUTDOOR DEPARTMENT

6 7

LOSS BREAKAGE DAMAGE ETC 6 8

PROCEDURE FOR WRITING OFF STORES 6 9

DISPOSAL OF WRITTEN OFF ARTICLES 7 1

FORMATS TO BE USED 7 3 - 81

32

STORAGE AND STOCK MANAGEMENT The expiry periods of pharmaceutical products have meaning only if the products are stored under proper conditions otherwise products are likely to lose their potency before the actual date of expiry

A pharmacist is a vital link in the distribution chain for pharmaceutical products The medicinal products remain for a long period during the distribution cycle at the wholesaler and at retail pharmacies It is therefore very important to maintain proper storage conditions in these units

Every community pharmacy however large or s mall needs to store and manage its medicine stocks effectively There must be systems to ensure

middot bullbull Secure storage middot bullbull Clean and correct environmental conditions during storage middot bullbull Accurate and effective record keeping middot bullbull Effective stock rotation and expiry monitoring middot bullbull Effective fire and theft prevention middot bullbull Effective rodent pest control

For easier un derstanding this module has been divided into the following sections

1 Quarantine and checking of stocks 11 Quarantine area 12 Checks to be carried out on new stocks

2 S t o r a g e 21 Need for proper storage 22 Different patterns of storage 23 Different means of storage 24 Temperatureclimatic conditions 25 Special storage of supplies 26 Storage and stability of medicines

3 Stock Control and Expiry Monitoring 31 Stock control 3 2 S t o c k r o t a t i o n a n d e x p i r y m o n i t o r i n g

4 Other aspects of s t o r a g e 41 Design of a storage area 42 Cleaning and maintenance 43 Product recalls 44 Returned goods

33

1 QUARANTINE AND CHECKING OF STOCKS

11 Quarantine Area D r u g S t o r e pharmacies receive stoc k s f r o m su pplie r s a c c or d ing to pur c h a se o r d e r s T he stock that is received must be visually checked for quality and quantity The stocks must be kept in a separate area until the checking is done to avoid intermixing with existing stock This necessitates the presence of a separate area within the pharmacy w h e r e i n t h e storage and other checking of stocks can be performed This area is called the QUARANTINE AREA This area should be marked and identified adequately to distinguish it from other areas

The area may be marked using different means 1 ) A s m a l l board saying Quarantine on a separate table used exclusively if it is in the middle 2) A board on the wall if the table on which the quarantine stock is placed is against the wall

middot Stock received from wholesalers should be immediately transferred t o t h e Quarantine Area

middot In the Quarantine area the stock may be stored on racks shelves or in cupboards to prevent ingress of moisture dirt and other contaminants

middot Regular stocks from the pharmacy should not be left kept in the quarantine area Special care has to be taken in case of refrigerated medicines supplied by the suppliers so tha t the y do not remain in the quarantine area for long periods of time They should be immediately checked on receipt and transferred to areas for refrigerated storage s o a s to maintain the cold chain bull

Advantages of having a separate Quarantine Area middot Avoids cross mixing of newly arrived stock from existing stock till it is checked middot Lays stress on checking the quality of the stock received middot S to ck checking ensures t hat defective andor expired goods do not enter the storage areas

34

bullbull

bullbull

12 Checks to be carried out on new stock

Unpacking and checking stock

Supplies received should be unpacked and checked in the quarantine area Staff doing the checks should be adequatel y trained in what they have to check when stock arrives

Checking should be seen not simply as counting the units received but as a part of the quality assurance system bullThis should include middot Visually inspecting the packaging middot Checking the integrity of containers middot V erifying the completeness and leg ibility of la b e ls ( a ppr o ve d dr u g name strength any special storage instructions and expiry date)

bull

The expiry dat e should be checked to ensure that there is adequate shelf life remaining

Supplies should be individually checked using a checklist 35

Checklists

36

The wholesaler supplying the product should be notified immediately in case of any discrepancies ( and the details should be recorded in a register) and sent in a written format to the supplier It should include middot Missing boxes or cartons middot O p en tampered boxes or cartons middot Missing supplies middot Differences in the actual quantity and the quantity shown on the packing middot Additional medicines that had not been ordered but have been supplied middot D a m a g e d b r o k e n o r p oor quality medicines middot Any other discrepancies

The purchase invoices are an important aspect to be considered The invoiced documents should be signed and filed for reference as per the Drugs and Cosmetics Act and retained for at least 3years

If the wholesaler supplies medicines as an emergency without a bill or against a delivery challan

middot The supplies should be checked for integrity and inspected for damage middot The details of supplies received should be recorded middot The supplier should be asked t o send the bill as early as possible middot When the bill is received it should be checked against the details recorded and anomalies if any should be reported to the supplier

To keep a track of the received stock maintaining a S t o c k R e c o r d C a r d c a n b e very useful The entries in the stock record card can be made while checking the stock received STOCK BIN in the stores should have Stock record card

Maintaining a stock card for every product may not be very practical for a retail pharmacy however it could be maintained for costly medicines Nowadays it is much more practical and easier to maintain records using computers

The pharmacist should ensure that medicines manufacturedmarketed by a company are received only through an authorized distribution network of that company This is important to prevent spurious and counterfeit drugs from entering the pharmacy

37

2 STORAGE 21 The need for proper storage The storage of medicines and other products is an important requirement of Good Pharmacy Pr actice Appropriate storage of medicines is essential -

middot bullTo ensure that the potency is maintained middot bullTo prevent deteriorationspoilagedegradation middot bullTo ensuremaintain physical integrity

To ascertain that the quality and safety is maintained throughout their shelf life Storage requirements need to be considered on 2 aspects

a) Integrity of medicines Medicines should be stored in such a way so as to maintain their integrity and potency middot Maintain the right temperature required middot Protect from excessive humidity middot Keep medicines away from direct sunlight middot Protect from pests and rodents

b) Physical location middot Should be easy to locate middot Accessible middot Orderlysystematically placed

2 2 D i f f e r e n t p a t t e r n s o f s t o r a g e The pharmacist could follow any of the different patterns of storage The pattern of stora ge should be selected in such a way that it facilitates speedy and efficient dispensing of medicines

The pattern of storage could vary with each pharmacy experience usual practiceroutine of staff and the person-in charge and also depending on space av ailable turnover etc (i) The medicines could be stored c o m p a n y w i s e ie the medicines manufactured by one company should be grouped together and kept in one place Within each company shelfshelves the medicines may be placed in alphabetical order for easy and quick placement and removal Also bottles tubes boxes etc may be segregated within that shelf

38

(ii) The medicines may also be stored in a lphabe t ic al o r de r ie they are placed in order from left to right based on their name The first letter of the name is used to g r o u p t h e m e d i c i n e s t o g e t h e r a n d k e e p t h e m i n o n e l o c a t i o n I n s o m e p h a r m a c i e s a l l t h e strip packing are placed in drawers or boxes in alphabetical order each box or drawer containing strips of one particular alphabet This system ensures that the strips always remain e n c l o s e d i n t h e b o x e s d r a w e r s a n d a r e n o t e x p o s e d t o d u s t T h e d i s a d v a n t a g e i s that it might lead to mix -u p o f strips in the same drawer and it may cause a problem incase of similar looking strips in which case a wrong medicine may be dispensed Secondly cut strips lying around in the drawer may lose their identity if the batch n u m b e r andor expiry date is not seen on the cut portion of the strip

39

(iii) The medicines may be stored according to their therapeutic class ( e g a n t i b i o t i c s anti asthmatics or anti hypertensives) ie the medicines are kept together based on their pharmacological or therapeutic action

(iv) The medicines may be stockedsegregated according to dosage forms eg l i q u i d s (bottles) solid oral dosage forms eye drops rotacaps ointments etc all stored on separate shelves

Always Remember I Storage of prescription medicines should preferably be separate from OTC medicines OTC medicines especially those that a r e a d v e r t i s e d m a y b e d i s p l a y e d f o r c l i e n t s t o select or to ask questions about [OTC-O v e r t h e c o u n t e r ] II Storage according to temperatures is a must no matter which pattern of storage is followed Also within a particular storage area segregated storage may be maintained In a refrigerator for example medicines may be stored in trays racks and the freezer according to the temperature required

40

Whatever pattern of storage is selected all the personnel should ensure that middot The stocks are stored in an orderly manner middot The medicines are kept back in the same place from where they were removed middot All medicines are arranged neatly once in a while

middot The personnel should be careful while storing the medicines middot They should not throw the medicines haphazardly 23 Different means of storage

middot Within each temperature and security zone medicines must be stored so that they are easily accessible and protected against damage

middot Basic means of storage include shelves racks and drawers middot To prevent dust from entering the shelvesracks it is ideal to have glass

shutterssliding glass doors This can however be disadvantageous because accessibilityspeed is hampered in removing a product from the shelf because the glassshuttersliding glass has to be

41

opened m o v e d e v e r y t i m e a p r o d u c t h a s t o b e p i c k e d u p U s e o f a i r c o n d i t i o n e r s f o r t h e p h arm acy with a closed door at the e n t r a n c e o r a n a i r c u r t a i n c a n r e d u c e t h e d u s t problem In such cases the shelvesracks may be left o p e n

bull

middot Direct storage of cartons on the floor should be avoided because besides being an unhealthy practice the contents may also be damaged by moisture bull

middot Store medicines preferably in shelves with glass shutters for visibility middot Closed shelves further prevent dust from going in especially in India where most

pharmacies are located along busy roads middot Some medicines have to be refrigerated or stored in a cool or cold place Having a

refrigerator or two (as per the need of the pharmacy) is essential to store suc h medicines at temperatures mentioned on the label bull

42

Refrigeration middot All cold chain equipment should meet required standards middot Improvement in refrigeration technology has provided frost -free refrigerators

Pharmacists should opt for frost-free refrigerators as they are easy to maintain and protect printed packaging materials Conventional refrigerators may cause water falling from trays below the freezer on medicines stored in the refrigerator thus causing soggy labels

middot bull Frost-free refrigerators also provide separate and large compartments for the freezer portion (required for storing medicines needing sub-z e r o t e m p e r a t u r e ) and the main storage area with separate doors so that opening one door does not disturb the storage temperature in the other compartment

Care should be taken to keep the refrigerator on 24 hours a day It should not be switched off after working hours It is advisable to have an inverter connected to the refrigerator so that the refrigerator re mains working even when there is a power outage

middot The refrigerator door should be closed tightly middot The refrigerator door should not be left open for too long middot Space should be left between medicines stored in a refrigerator to allow air to

circulate middot The ref rigerator should be placed about an arms length away from the wall

This will increase air circulation thus not affecting the cooling within the refrigerator

middot Vaccines should not be stored on refrigerator door shelves as they are exposed to warmer temperatures each time the door is opened Vaccines should always be stored on the middle shelves of the refrigerator

middot Refrigerated medicines should not be left out of the refrigerator for more than a few minutes

43

middot Consumable products like juices energy drinks e t c s h o u l d n o t b e s t o r e d a l o n g with medicines in refrigerators If required they may be kept in a separate refrigerator

middot An adequate number of refrigerators should be planned to store the entire stocks requiring refrigerated storage

middot Adequate procedures should be followed for defrosting cleaning and maintenance of refrigerators

middot Icefreeze packs should be kept in the freezer compartment so that they can be used for transporting cold temperature medicines The packs can be given to clients along with the medicines requiring cold temperature storage so that the temperature is maintained till the client reaches home and can then put the medicines in a refrigerator) Freezer packs can also be used to keep medicines temporarily in case there is a power outage or refrigerator breakdown

Activity

Prepare a SOP (Standard operating procedure chart) for cleaning a refrigerator Discuss it with your staff finalize its maintenance once a month through AMC -A n n u a l Maintenance contract CMC - Comprehensive maintenance contract and put it up on the pharmacy refrigerator Put the Purchase Order details name of manufacturer Phone of Service Engineer and a register to login the Machine service and down timeService reports may be maintained properly

Refrigerator monitoring and maintenance

middot bullIt is important to carry out routine monitoring and maintenance of the refrigerators and to organize an effective repair system

middot bullThe temperature in the refrigerator must be monitored and recorded routinely at least once a day

middot Any breakdown must be reco rded including the period during which the medicines were exposed to uncontrolled temperatures Medicines may then be kept or discarded depending on the problem guidelines or the manufacturers advice

middot Cold chain monitor cards and devices in or on packages that change color or otherwise alert staff to potential damage assist in monitoring (These are likely to be introduced in India soon)

middot It is essential to have a contingency plan in place before a refrigerator breaks down An arrangement can be made to move the contents to a private refrigerator elsewhere in the community or to obtain a regular supply of ice packs until the defect is rectified

Put filled water bottles in the bottom half of the refrigerator door in order to provide cooling in the refri g e r a t o r w h e n t h e r e i s a p o w e r o u t a g e T h i s m i g h t t a k e c a r e o f t h e temperature when there is no current for a couple of hours If the power outage is expected to last for several hours special arrangements such as an inverter UPS have to be made to keep the refrigerator constantly running in the absence of electricity middot Defrost the refrigerator in case of excessive ice formation and preferably at regular

intervals Keep a record of the same

44

2 4 T e m p e r a t u r e c l i m a t i c c o n d i t i o n s

i) Temperature control middot The medicines in a pharmacy need to be stored at appropriate temperatures to

maintain their stability middot An air-conditioned environment where temperature can be controlled is

recommended for pharmacies Air conditioning offers the option of setting the t e m p e rature as per requirements

middot bullIt is ideal to have an air conditioner to maintain the temperature below 25 C as most medicines require storage below this temperature Secondly this temperature is pleasing to both the staff and the visiting customers too

middot In the absence of an air conditioner circulating fans may be used middot This need is felt even more in certain parts of India where temperatures soar above 45

C and some areas where it falls to sub zero temperatures In such cases temperature maintenance is essential to prevent deterioration of medicines due to unnecessary exposure to drastic temperature fluctuations

middot This need is felt even more in certain parts of India where temperatures soar above 45 C and some areas where it falls to sub zero temperat u r e s I n s u c h c a s e s temperature maintenance is essential to prevent deterioration of medicines due to unnecessary exposure to drastic temperature fluctuations

i i ) Humidity or moisture control Moisture or humidity can adversely affect the stability of me dicines such as tablets capsules powders

45

Gelatin capsules become soft and swell on absorption of moisture The drug content of tablets may undergo surface hydrolysis The presence of moisture may encourage the growth of microbes It is therefore essential to control humidity

To reduce the effect of humidity the following suggestions may be followed -middot Open the windows to allow air circulation Use a fan to circulate fresh (outside) air middot In humid climate a dehumidifier is useful for preventing mo i s t u r e d a m a g e ( i n t h e absence of an air conditioner) middot For bulk containers of tabletscapsules do not keep the container open for a long time and replace the lid or closure immediately after taking out the required number of medicines for dispensing middot Do not allow the medicines to touch the floor or the walls The walls may be damp and may cause moisture absorption damaging the product

middot Calibrated thermometers and manometers can be used to detect temperature and humidity in the pharmacy

middot Periodici t y of checking the temperature should be fixed middot The climatic conditions should be recorded and documented middot Temperature charts should be available for ready reference

Documentation is one of the core activities for achieving and maintaining quality It is one of the most essential components of validation Temperatures in various areas

46

including refrigerators should be recorded at a predetermined periodicity usually daily at the hottest time of the day and such documents should be preserved i i i ) Storage conditions A number of storage conditions are mentioned on the labels of medicinal products These conditions have to be properly interpreted and appropriately complied with

According to the Drugs and Cosmetics Rules 1945

1 The term cool place means a place having a temperature between 10 C and 25 C

2 The term cold place means a place having a temperature not exceeding 8 C In case of storage conditions for specific products please refer to Schedule P The Drugs and Cosmetic Rules 1 9 4 5

The Indian Pharmacopoeia specifies the following storage conditions -

Wherever the condition for storage is not specified medicines may be stored under normal temperature In a country like India however where normal temperatures soar to h i gh temperatures it is recommended that medicines be stored in a cool place

Activity Prepare a list of the storage requirements mentioned on the label of about 20 products in your pharmacy and check if the temperature is maintained

47

25 Special Storage o f s u p p l i e s If the product has no special instructions normal storage conditions apply This means storage in dry clean w e l l -ventilated premises at temperatures of +15 C to +25 C or depending on the climate up to +30 C (WHO1990) Storage instructions are product specific Different brands of the same generic drug may have different storage requirements as they may have different packaging or formulations It is essential to follow the product manufacturers storage instructions to the maximum extent possible Less stable medicines must be stored in specific conditions to maintain their quality or potency

The following products require special storage facilities

middot Products that must be kept frozen (usually vaccines and sera) middot Products sensitive to h eat an d r e q uir in g r e f r ig e r a tio n ( +2 C to +8 C) middot Products that have reduced shelf life at uncontrolled room temperature and need

mechanical ventilation or air conditioning middot Flammable products that require separate fireproof premises middot Products prone to theft o r m i s u s e

Products needing storage in a controlled environment -

The usable shelf life of the following products may be reduced if stored at uncontrolled humidity or at room temperature in hot climates -

middot Some injectables (eg adrenaline) Most injectable preparations are less stable than solid oral forms (tablets and capsules) Injectable preparations in solution are particularly unstable Many injections must be protected from light as well as heat

middot Intravenous fluids (particularly if packed in p lastic containers) middot Some suppositories pessaries creams and ointments These products may melt at

temperatures greater than 30 C Once this happens it is not advisable to use them because the active ingredient in the formula may get unevenly distributed

middot Products containing rubber latex cellulose or some plastics Condoms most sterile disposable medical devices and surgical products such as syringes needles and catheters require protection from excessive humidity and strong light and heat Any o f these conditions may make products brittle stained amp unusable Sterility cannot be assumed if packaging is damaged

In hot climates these products should be stored in the coolest place possible preferably with air conditioning or air circulation fans

48

Products needing freezing or refrigeration-middot Vaccines blood products and many other medicines lose potency if kept even for a

brief period at temperatures outside the recommended range For these products the cold chain must be maintained at every stage of the distribution system

middot Freezing is as damaging as high temperatures for some products including injectable contraceptives ergometrine insulin adrenaline and the DPT DT TT and Hepatitis B vaccines Such products therefore sho uld not be allowed to freeze (not be kept in the freezer compartment)

middot Short periods at room temperature (during transportation or local distribution for instance) may be acceptable for many products (such as ergometrine a n d i n s u l i n ) e v e n t h o u g h s u c h e x posure can to some extent reduce shelf life Other items such as vaccines should always be transported in cold boxes

Storage of insulin injections-

middot Insulin should always be stored in a refrigerator at the recommended temperature of 2 -8 C

middot Insulin should not be kept in the freezer compartment of the refrigerator middot Insulin should ideally be stored horizontally middot It should not be exposed to sunlight or excessive heat middot Insulin suspensions should not be used if the suspension cannot be properly

resuspended due to cake or clump formationbull

Controlled drugs -Narcotics (for example Pethidine injection morphine preparations) and other specified drugs that may be abused are governed by special legislation and regulations The following security measures are suggested in the pharmacy -middot A safe or reinforced double locked cabinet fitted with a light (preferably with a red

bulb) that comes on when the door is opened

49

middot A special register recording details of each receipt or issue with 2 signatures physi cal counting of medicines after each entry and signatures at handover takeover

middot Independent audit (by supervisors and drug inspectors)

Products prone to theft abuse or misuse -

Some medicinesproducts are particularly prone to theft abuse or misuse These include expensive medicines (eg insulin) certain antibiotics and products prone to abuse or misuse like psychotropics etc

Such medicinesproducts should be stored adequately They require stricter record keeping and more frequent stock taki ng than others Periodic audits should be carried out to check for consumption against actual recorded use (registers prescription records stock records etc) to expose any theft or misuse bull26 Storage and stability of medicines Medicines are not stab le indefinitely They are stable for a specific period of time sometimes for a brief period Poor storage conditions accelerate the drug degradation (decomposition) Temperature light and moisture are the most important contributing factors for drug instability It is important to identify and be aware of the potential for instability There is a need to comply with storage requirements to ensure quality medicines for patients It is also important to offer advice to patients too about appropriate storage o f medicines at home The dispensing label should state the storage condition required and be backed up by a verbal reminder especially where special storage is required bull

50

In case stability and storage problems are seen with formulations they should be reported immediately to the representative of the manufacturer and taken out of circulation till the stability problems have been resolved

The pharmacist can easily detect stability problems when products show change in appearance color odor settling of the product contents breaking of emulsions melting of creams oozing of contents from the containers and any such physical changes

3 STOCK CONTROL AND EXPIRY MONITORING 3 1 S t o c k C o n t r o l For economic reasons pharmacists do not like to have stock on their shelves for long periods of time The aim should always be to keep stock at a level that will just meet demand Normally most manufactured medicines have a long shelf life Even then it is essential that there is efficient stock rot ation so that the older stock is used first It is also a good practice to check the expiry date as an integral part of the dispensing process When short shelf life products are involved stock levels may have to be modified to prevent medicines regularl y expiring on the shelves

32 Stock rotation and expiry monitoring In order to avoid accumulation of expired and obsolete stock medicines should be stored and issued according to the following guidelines -middot The stock control system must record the ex p i r y d a t e a n d t h e d a t e o f r e c e i p t middot Stock must be stored so that earliest expiring batches are picked and issued first middot The First In First Out (FIFO) system - In this system the stock which is received

first is sold first This system however may not be useful for pharmacies because most of the stocks carry an expiry date For pharmacies the FEFO system is more practical

51

middot The First Expiry First Out (FEFO) system - In this system the stock having an earlier expiry is sold first The stock with longer shelf life should be placed farthest to the back (or at the bottom in case o f sta c k e d b oxe s) T h is is pa r tic u la r ly impor ta n t with products that have short shelf lives such as vaccines some vitamins antibiotics etc and reduces losses due to expiry

middot E x p i r y dates should be noted on the stock record upon receipt Stock nearing expiry should not be accepted unless it can be used before expiry

Computerization and expiry monitoring In the pharmacy computerization facilitates both checking stocks and expiry mo nitoring and helps-bullbullKeeping a check on products nearing expiry bullbullKeeping a check on non- moving and slow moving products bullbullTo facilitate the removal of medicines nearing expiry from shelves in time to send them back to the wholesaler or supplier

Periodic checking for expiry The expiry date for medicinal products is a critical aspect in pharmaceutical dispensing and due importance should be given to it Periodic checking for expiry of medicines will ensure that the patient will never receive products that have crossed their expiry date During periodical checking of expiry the personnel involved should remove medicines that are nearing expiry bullbullIn -house threshold periods should be set and followed for retrieval of such medicines from the shelves bullbullSuch medicines should be stored separately These should either be dispensed immediately (thus ensuring that they are used before the expiry date) o r t h e y s h o u l d b e returned to the suppliers bullbullA separate area should be designated (cupboard or shelf)marked[FROZEN ZONE] which is adequately marked EXPIRED GOODS- NOT FOR SALE to store all expired stocks FROZEN ZONE

52

Remember Expired medicines are a NATIONAL WASTE So stock only what you can sell Avoid expiries save precious medicines for the nation

Treatment and disposing of expired medicines bullbullProcedures need to be in place for the treatment of expired medicines bullbullThe expired medicines need to be collected and be sent back to the supplier or company for appropriate disposal bullbullRecords must be maintained for expired medicines and how they are disposed off bullbullIn case of medicines that are not returnable to suppliers procedures for disposal need to be followed by the pharmacy in conjunction with the FDA The following procedure can be followed if medicines cannot be returned to suppliers ( T h e b a s i c p h i l o s o p h y of appropriate disposal is to prevent their re- circulation and use) bullbullC u t t h e c o n t ainer in such a manner that the label is also cut In case of tablets and c a p s u l e s d e s t r o y them by disposing them in a bucket of water bullbullUse landfill procedures (deep burial into the ground as per stipulations of Medical Waste Disposal Act prevalent in the respective state) bullbullPour the liquids into the sink and wash away with sufficient quantity of water bullbullKeep a record of such disposal with full details of medicines destroyed Although these measures are usually adopted care has to be taken with such tr e a t m e n t a s studies have shown that flushing of medicines has resulted in tracessmall quantities of medicines being found in waterways and groundwater having potential health and environmental effects

4 O T H E R A S P E C T S 41 Design of storage areas The following important factors need to be considered in design of storage areas -middot The retail outlets in hot areas in summers should be air-conditioned Similarly in

a r e a s o f e x t r e m e c o l d t h e p r e m i s e s w o u l d r e q u i r e w a r m i n g e s p e c i a l l y i n w i n t e r s t o maintain cool temperatures The placement of air -conditioners and heating devices should be such that medicines are not directly exposed to the cold or heat

middot Due consideration should be given to storage requirements of formulations while designing shelves and cupboards in retail outlets Sufficient shelf height should be provided so that all liquid products can be stored vertically As far as possible the shelves should be covered with glass panels to protect medicines from dust and p r e v e n t r a p i d f l u c t u a t i o n s i n temperature

middot Medicines should be stored according to the storage instructions on the labels bullIt is ideal to have a door at the pharmacy entrance to prevent dust from coming in as well as reduceprevent cooled air from going out This may not however be considered feasiblepracticable by many pharmacy owners for fear that clients may not enter the pharmacy because the door may act as a barrier An air curtain is a good alternative to a door

middot There should be minimal direct sunlight falling on the products Particular consideration should be given to premises directly facing the sun

middot bullThe arrangement of lighting in the interior of the premises should also be in a manner that the lights are not focused on the products It has been shown that light causes not only chemical damage but also can catalyze physical changes like moisture uptak e by the products Care should be taken to ensure that only diffused light falls on them

53

middot As far as possible provision should be made for a temperature and humidity indicator device in a pharmacy These devices are now easily available

middot Stability studies o f m e d i c i n e s p a c k e d i n b l i s t e r s h a v e r e v e a l e d t h a t i f t h e s e a r e exposed to light they tend to absorb moisture It is therefore necessary to store them in suitable cartons so that the blisters are not exposed to light Pharmacists should do this even if the manufacturer has not provided cartons

middot Light and temperature sensitive products should not be stored on counters where the light is intense or direct and there is no protection from temperature and humidity

42 Cleaning and maintenance i) Cleaning of storage areas

The storage areas of the pharmacy should be cleaned periodically and cleanliness should be maintained at all times The Standard Operating Procedure for cleaning should be designed and followed accordingly Schedules for cleanups should be laid down and adequate cleaning equipment should be made available

Tips for maintaining cleanliness middot Provide clean pieces of cloth for wiping at various locations in the pharmacy

Replace with clean cloth at regular intervals middot Keep separate pieces of cloth for floors shelves and medicines middot Use a disinfectant andor soap solution to clean floors middot Ensure removal of dust and prevent accumulation of dirt middot Ensure removal of cobwebs middot Use a vacuum cleaner for cleaning areas not easily reachable middot T a k e c a r e t h at breakages are handled and cleared effectively middot Observe the factors leading to waste generation in the pharmacy and take appropriate

measures to tackle the problem middot Record all cleaning procedures performed and maintain all the documents required

For ex a m p l e -bullbullThe floor of the pharmacy may be swept with a broom and swabbed with soap water every morning bullbullThe floor may be swabbed with a disinfectant every week bullbullThe entire premises including shelves and cupboards may be cleaned with a cloth (to remove dust and to check for medicines approaching expiry date or expired medicines) every three months bullbullAll the steps followed should be r e c o r d e d

The floor shelves drawers have to be cleaned and a check should be kept on dust cobwebs spillages due to breakage etc It is therefore essential to have SOPs for cleaning laying down cleaning frequencies allotting responsibilities and maintaining a daily record in the logbook to document all these activities

54

While cleaning dust settled on dosage forms like bottles tubes etc should be removed Before dispensing the products should also be wiped to remove any dust settled during storage

For refrigerators bullbullDefrosting and cleaning should be done at regular intervals bullbullSwitch off the refrigerator while cleaning bullbullCleaning should be done quickly and stocks put back immediately

i i ) Pest control Pests are a serious problem in India where insects reptiles and rodents (eg cockroaches l i z a r d s r a t s s i l v e r f i s h (Deemak - in Hindi ) etc) may find access to the pharmacy storage areas Insects like ants and borer ants may often attack wood in the pharmacy causing d am ag e to shelves cupboardsPest c ontr o l in a p h a r m a c y c a n b e a d i f f i c u l t t a s k b u t t o avoid possible contamination and physical damage to stock it is necessary to keep pests out of the pharmacy premisesPest control measures should be implemented with proper p r e c a u t i o n s t a k i n g u t m o s t c a r e t o a v o i d contamination of medicines

55

Th e following pest control measures c a n be ta ke n f r om tim e to tim e -bullbullRat bait and traps can be placed at various locations bullbullInsecticutors can be used on a permanent basis bullbullInsecticidal sprays and repellants can be used from time to time

i i i ) Fire precautions

Combustible trash such as cartons boxes and other packing waste must not be allowed to accumulate in the store Waste should be deposited in appropriate waste bins and be d i s p o s e d o f f o n a d a i l y b a s i s

F i re detection and fire fighting equipment must be maintained and regularly inspected The pharmacy personnel should receive adequate training in fire fighting techniques and emergency actionFire prevention measures should include a prominently displayed ldquoNoSmokingrdquo sign careful handling and disposal of combustible waste materials and checking of electrical connections at regular intervals

iv) Security middot Doors shutters of the pharmacy should be strong and be fitted with secure locks middot Counters should be designed so that unauthorized personnelclients do not have

access to areas where prescription medicines are stored Access to such areas should be restricted to the pharmacy staff

middot All the pharmacy staff handling supplies should be accountable for their ac t i o n s

56

middot bullSpecial care must be taken in case of Schedule X and manufactured drugs (under NDPS Act) Such medicines should be kept under lock and key and the key should be kept with the Chief Pharmacist or i n h i s a b s e n c e t h e s e n i o r p h a r m a c i s t

v) Breakagespillage and damaged product Products that have been damagedspoiled during storage and handling spillages and broken glassware should be disposed off according to procedures laid down by the pharmacy Broken and damaged products s h o u l d b e p l a c e d i n a segregated area to be returned to the supplier

vi) Inspection Senior staff should inspect all pharmacy areas regularly The shelves and drawers should b e c h e c k e d d a i l y f o r signs of pests and dust Ceiling and walls should be checked for dirt and cobwebs Stock should be checked on a regular basis for deterioration due to climatic conditions

43 Product recalls Products found to be defective should be quickly recalled (withdrawn from the market) The instructions are generally issued either by the manufacturer or the regulatory agency The level of recall is determined by both the degree of risk and the extent of distribution of the product and in India is mainly directed at the distribution chain

On receiving the details of the defective substandard spurious batchbatches of a medicine to be recalled from the manufacturer or the stockist or the FDA the pharmacy should immediately check if the particular b a t c h i s i n s t o c k a n d i f s o s u s p e n d i t s s a l e immediately

Similarly if the regulatory authority in the country bans a particular medicine or FDC the pharmacy should immediately check and remove all the different brands of that particular medicine under consideration

The details of medicines and their batches to be recalled should be available in the q u a r a n t i n e a r e a w h e r e stocks are received and checked This is to ensure that such medicines do not come into the pharmacy

middot The pharmacy should develop SOPs for recall of medicines middot The pharmacy staff should be immediately informed about such medicines and

the details should be displayed in writing in a prominent place in the pharmacy middot Rapid action helps avoid unnecessary exposure to such medicines once the

problem has been d e t e c t e d middot The progress of the recall procedure in the pharmacy should be monitored every

few days to ensure complete compliance middot All stocks of the recalled products should be stored separately from the saleable

stock These can be stored in the expiry cupboard segregated from the expired goods and be appropriately labeled ldquoRecal l e d G o o d s - Not for Salerdquo

The supplier should be notified and asked to replace defective products middot All the details of the procedures followed should be duly recorded in a Recall

Register maintained specially for the purpose The register should include d etails such as -middot Date of the recall middot Nam e of the product

57

bullbull

middot Details of the product (name of manufacturer batch number expiry date) middot Nu m b er of units purchased sold a n d sto c k in ha nd middot Reason for recall middot Nam e of the supplier to whom produc ts w e r e returned along with the date and quantity middot Name and signature of the designated personnel carrying out the recall procedure and recording details middot Name and signature of the chief pharmacist verifying the recall procedures and recording details 4 4 Returned medicines

Medicines may be returned to the pharmacy by clients due to the following reasons -bull

bullbull Unused medicines bullbull Course not completed bullbull Therapy changed by doctor bullbull Side effects experienced by patient bull

bullbull DamagedDefective medicines bullbull Missing or defaced label bullbull Missing tablets in a stripblister bullbull Leakage in bottles bullbull Leakage in strips bull

bullbull Expired medicines

Appropriate SOPs should be framed and followed for their acceptancerefusal and disposal middot bull For unused medicines returned by clients the p harmacy personnel should verify

that these were purchased from their pharmacy They should then be checked for integrity of the packing the dosage form and the expiry date and verified with the client whether they were stored in appropriate conditions This again is at the discretion of each pharmacy

middot The damageddefective medicines returned to the pharmacy should be taken back and stored separately Existing stock of the same product should be checked for similar defects

middot Expired medicines should be accepted from clients at the discretion of the pharmacist and be immediately shifted to the expired goods cupboard These can be stored segregated from the pharmacys own expired goods and be appropriately labelled ldquoExpired Goods returned by clients- Not For Salerdquo

It is advisable not to accept returned medicines requiring cold chain storage (refrigeration) because it cannot be ensured that the cold chain was maintained when the medicines were in the hands of the patientclient middot Appropriate adjustments in t he stocks should be made for medicines

returnedexchanged to update the inventory middot The medicines should then be returned to the respective shelves middot A lsquoReturned Goodsrsquo register needs to be maintained to record all details of returned

medicines

R egister should include such details as-

58

middot N a m e o f t h e p a t i e n t middot Nam e of the product and quantity r e tu r n e d middot Product details such as the batch number and expiry date middot Condition in which received middot Reason for returning products middot Compensatory measures taken wi t h r e s p e c t t o c l i e n t middot Action taken with respect to product middot Name and signature of the personnel accepting the returned medicines and recording details middot Name and signature of the chief pharmacist verifying the recorded details

What the pharmacist would have learnt from this module The storage of medicines is a critical factor in the distribution cycle bullbull Stocks received by the pharmacy should be quarantined in a separate area and necessary checks s h o u ld be performed to ascertain the qua lity a nd quantity of stocks received bullbull Whatever pattern and means of storage used the products should be stored so as to maintain their potency and integrity bullbull Storage conditions should be monitored and maintained on a regular basis bullbull Optimum stock levels should be maintained and regularly monitored for expiry bullbull The design of storage areas should facilitate appropriate storage of medicines bullbull Cleanliness should be maintained in the pharmacy bullbull Adequate measures should be taken in case of returned medicines and recalled products

Optimum storage of medicines is mandatory whether at the distribution stage at the pharmacy or ultimately within the homes of patients The pharmacist has an important r o l e t o p l a y i n t h e s t o r a g e o f m e d i c i n e s i n m a i n t a i n i n g d r u g p o t ency and efficacy and thus facilitating optimum therapeutic benefits Good Pharmacy Practice - IPA -CDSCO - WHO Appendix I Quality Assurance Templates of letters for use if found not of Standard Quality [Frozen and expired goods ]

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated To Name of the Supplier with address

Sub Not of Standard Quality GoMP-Supply of Drugs and medicines-(Codename) Return of Stocks to the Suppliers-reg(New drug policy 2009) Previous letterinvoice ref Sl No Drug Code Drug name

Manufacturing date Expiry date

Supplier address

B a t c h n o

The above items of PO nodated was drawn by the Drug Inspector (Place) on (______________date) as a statutory sampling and declared ldquoNot of Standard

59

Qualityrdquo on -(______________date) by the Government Analyst for the following reasons

- ldquoThe product sample do not confirm to IP specification for (Drug codename with respect to the content of drugrdquo

- ldquoThe product has already been blacklisted by TNMSC on -(______________date) for the failure of (quantity) of batches of drug codenamerdquo

As per the clause of the te nde r d oc um e nt ldquo I f the sa mple s d o not c onf o r m to statutory standardsthe tenderer will be liable for relevant action under the existing laws and the entire stock in such batch should be taken back by the tenderer within a period of 30 days o f t h e r e c e i p t o f t h e l e t t e r f r o m t h e v e n u e

The stock shall be taken back at the expenses of the tendererthe Procurement Authority have the right to destroy such Not of Standard Quality if the tenderer does not take back the goods within the stipulated time

The Procuring Authority will arrange to destroy the Not of Standard Quality drugs within 90 days after the expiry of 30 days mentioned above without further notice and shall also collect demurrage charges calculated at the rate of 2 per week on the value of the drugs rejected till such destructionrdquo

Hence we regret to inform you that you will have to take back the stocks available of the abovesaid batch at your own cost from the drug stores where you have supplied the above batch

Kindly acknowledge the receipt of this reference at once

P r o c u r e m e n t A u t h o r i t y Seal and Stamp

Copy to Ref No dated

1 ) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated13082010

To

Sub Frozen Drugs-ordered to return to the Suppliers-reg(New drug policy 2009) Previous letterinvoice ref

The following products which were earlier frozen have now been ordered to return to suppliers directly with permission from the State drug Authority In this regard the suppliers have been instructed to take back their failed batch from the drug store of the stores Hence you are now instructed to return the following failed batches to the suppliers by obtaining proper authorization letter and acknowledgements from them

60

Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

Kindly acknowledge the receipt of this reference at once

Procurement Authority Seal and Stamp

Copy to

Ref No dated 2) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated14092010

To

Sub Frozen Drugs-ordered to return to the Suppliers- for issue of gate pass after verification reg(New drug policy 2009) Previous letterinvoice ref

The following products which were earlier frozen have now been released Hence they may be issued Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

Kindly acknowledge the receipt of this reference at once

Procurement Authority Seal and Stamp

Copy to

61

Ref No dated 3) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated

To

Sub Stop instruction-reg(New drug policy 2009) Previous letterinvoice ref

Until further instructions stop issue all the batches of the following item Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

You must intimate the available stock in the stores of the said batch Number to the Procurement Authority immediately Also retrieve quantity if already issued

Procurement Authority Seal and Stamp

Copy to

Ref No dated 4) HOD Procurement Office of

62

Appendix II Material handling in drug stores

Rack approx rates and dimensions

S No

Item Description UOM Approx Rate

1 MEDIUM DUTY RACK SIZE 2900 H X 3090 W X 800 D IN MM (AS PER SPECIFICATION)

Each 2499800

2 MEDIUM DUTY RACK ADD ON UNIT FOR SIZE OF SR NO2

Each 2243100

To locate a Box no 3 Rack no 14 in row3

SAMPLE OF RACK no Bin numbering -------------- S a y R K 1 4 R o w 3 B o x 1 6

SAMPLE LAYOUT of RACKS in a Drug Stores

63

Sample of another warehouse of distribution warehouse system

64

65

Slotted Angle racks with bin cards

66

Plastic Pallets

Plastic pallets ar e l i g h t w e i g h t l o w- c ost and exceed industry standards for strength and durability

NOTE A pallet has bottom deckboards (see sketch) A skid does not have bottom

67

deckboards

Battery Operated Stacker

Electric Stacker Ehh (Manual Push Type) - Manual drive - Lifting electrically with Battery 12 V 88 Ah - For loading and un-loading of trucks - Battery and loading device built - in - Battery charge gauge and charging current gauge Simple and Easy Operation - Lifting and Lowering electrically direct on steering arm - Pulling and pushing through steering arm - Electrically operated relief valve on hydraulic aggregate Safe Operation - Emergency Off Switch - Constant lowering speed - Protection through lowering brake valve - Overload protection through overload brake valve - Load chains covered preventing pinching threat - Electrically interlocking during loading process - Secured battery compartment opens upwardly - Stable buffering of the steering arm in upright position - In accordance with EWG Guidelines 89 240 - In accordance with VBG 12b Prevention of Accidents

Pallet Truck [ Top ]

68

----------------------------------------------------------------------------------------------------------------------------

For Transport Of All Goods On Pallets Safe and Easy Operation - through single hand operation Lifting moving

lowering with steering handle - neutral position of the hydraulic possible - overload pressure relief valve Long Service Life - robust co n s t r u c t i o n

- special hardened axles - hardened chromium plated ram - maintenance free Easy Maneuverability - through rubber steering rollers - nylon fork rollers

A h a n d t r o l l e y

69

Trolley with plastic bins for several items del ivery

70

Digital Weighing balances

Balances amp Scales EF Seriers Precision Electronic Balance

71

1

Ice lined Refrigerators

600 litres refrigrator

72

Walk in cooler

vacuum cleaner

73

Foreword

The New Drug Policy 2009 is being implemented in the State of Madhya Pradesh

In order to have a proper procedure for Storage maintenance and expiry management of the drugs it is necessary to follow Good Storage Practices with Standard Modules for pharmacistStore keepers

Proper guidelines on Storage Practices can lead to better Stores and inventory upkeep with medicines being properly stored in racks with proper cleanliness and hygiene

This is a step towards storage maintenance and expiry management at the various stores in the state Looking forward to see that the heads of all health facilities take benefit from this module

D ir e c t o r M e d i c a l S e r v i c e s

30

INDEX

Sr No P a r t i c u l a r s P a g e

1 S T O R A G E A N D S T O C K M A N A G E M E N T 4

1 Quarantine and checking of stocks 11 Quarantine area 12 Checks to be carried out on new stocks

2 S t o r a g e 21 Need for proper storage 22 Different patterns of storage 23 Different means of storage 24 Temperatureclimatic conditions 25 Special storage of supplies 26 Storage and stability of medicines

3 Stock Control and Expiry Monitoring 31 Stock control 32 Stock rotation and expi r y m o n i t o r i n g

4 Other aspects of storage 41 Design of a storage area 42 Cleaning and maintenance 43 Product recalls 44 Returned goods

2 A p p e n d i x 1 Templates of letters for use if found not of Standard Quality [Frozen and expired goods ]

Frozen Drugs-ordered to return to the Suppliers-reg(New drug policy 2009)

Frozen Drugs-ordered to return to the Suppliers- for issue of gate pass after verification reg(New drug policy 2009) Stop instruction-reg(New drug policy

2009) Appendix II Material handling in drug stores

31

3 PROCUREMENT ndash Government Order Relating to

the Management of Stores

(Reproduced for reference material on basic

procedure in decentralized system followed by

Health facilities in 1977)

54

F L O W C H A R T S f o r a BI R D S E Y E V I E W o f

P R O C U R E M E N T

5 5

ACQUISITION OF STORES 6 1

PLACING OF ORDERS 6 2

RECEIPT OF STORES 6 2

CUSTODY 6 3

ISSUE OF STORES Maintenance of Stock Books

6 3

PROCEDURE OF INDENTING FOR WARD amp OTHER SECTIONS OF THE INSTITUTION

6 4

HOW OFTEN TO INDENT 6 5

EMERGENT INDENT 6 5

HOW TO INDENT 6 5

KEEPING OF RECORDS IN WARDS A N D S E C T I O N S

6 6

ACCOUNTABILITY OF DRUGS BROUGHT BY THE PATIENT OR RECEIVED IN DON A T I O N BY T H E WARDSECTION _IN - CHARGE

6 7

RESPONSIBILITY OF STORES AT VARIOUS LEVELS

6 7

DISTRIBUTION OF MEDICINES FROM OUTDOOR DEPARTMENT

6 7

LOSS BREAKAGE DAMAGE ETC 6 8

PROCEDURE FOR WRITING OFF STORES 6 9

DISPOSAL OF WRITTEN OFF ARTICLES 7 1

FORMATS TO BE USED 7 3 - 81

32

STORAGE AND STOCK MANAGEMENT The expiry periods of pharmaceutical products have meaning only if the products are stored under proper conditions otherwise products are likely to lose their potency before the actual date of expiry

A pharmacist is a vital link in the distribution chain for pharmaceutical products The medicinal products remain for a long period during the distribution cycle at the wholesaler and at retail pharmacies It is therefore very important to maintain proper storage conditions in these units

Every community pharmacy however large or s mall needs to store and manage its medicine stocks effectively There must be systems to ensure

middot bullbull Secure storage middot bullbull Clean and correct environmental conditions during storage middot bullbull Accurate and effective record keeping middot bullbull Effective stock rotation and expiry monitoring middot bullbull Effective fire and theft prevention middot bullbull Effective rodent pest control

For easier un derstanding this module has been divided into the following sections

1 Quarantine and checking of stocks 11 Quarantine area 12 Checks to be carried out on new stocks

2 S t o r a g e 21 Need for proper storage 22 Different patterns of storage 23 Different means of storage 24 Temperatureclimatic conditions 25 Special storage of supplies 26 Storage and stability of medicines

3 Stock Control and Expiry Monitoring 31 Stock control 3 2 S t o c k r o t a t i o n a n d e x p i r y m o n i t o r i n g

4 Other aspects of s t o r a g e 41 Design of a storage area 42 Cleaning and maintenance 43 Product recalls 44 Returned goods

33

1 QUARANTINE AND CHECKING OF STOCKS

11 Quarantine Area D r u g S t o r e pharmacies receive stoc k s f r o m su pplie r s a c c or d ing to pur c h a se o r d e r s T he stock that is received must be visually checked for quality and quantity The stocks must be kept in a separate area until the checking is done to avoid intermixing with existing stock This necessitates the presence of a separate area within the pharmacy w h e r e i n t h e storage and other checking of stocks can be performed This area is called the QUARANTINE AREA This area should be marked and identified adequately to distinguish it from other areas

The area may be marked using different means 1 ) A s m a l l board saying Quarantine on a separate table used exclusively if it is in the middle 2) A board on the wall if the table on which the quarantine stock is placed is against the wall

middot Stock received from wholesalers should be immediately transferred t o t h e Quarantine Area

middot In the Quarantine area the stock may be stored on racks shelves or in cupboards to prevent ingress of moisture dirt and other contaminants

middot Regular stocks from the pharmacy should not be left kept in the quarantine area Special care has to be taken in case of refrigerated medicines supplied by the suppliers so tha t the y do not remain in the quarantine area for long periods of time They should be immediately checked on receipt and transferred to areas for refrigerated storage s o a s to maintain the cold chain bull

Advantages of having a separate Quarantine Area middot Avoids cross mixing of newly arrived stock from existing stock till it is checked middot Lays stress on checking the quality of the stock received middot S to ck checking ensures t hat defective andor expired goods do not enter the storage areas

34

bullbull

bullbull

12 Checks to be carried out on new stock

Unpacking and checking stock

Supplies received should be unpacked and checked in the quarantine area Staff doing the checks should be adequatel y trained in what they have to check when stock arrives

Checking should be seen not simply as counting the units received but as a part of the quality assurance system bullThis should include middot Visually inspecting the packaging middot Checking the integrity of containers middot V erifying the completeness and leg ibility of la b e ls ( a ppr o ve d dr u g name strength any special storage instructions and expiry date)

bull

The expiry dat e should be checked to ensure that there is adequate shelf life remaining

Supplies should be individually checked using a checklist 35

Checklists

36

The wholesaler supplying the product should be notified immediately in case of any discrepancies ( and the details should be recorded in a register) and sent in a written format to the supplier It should include middot Missing boxes or cartons middot O p en tampered boxes or cartons middot Missing supplies middot Differences in the actual quantity and the quantity shown on the packing middot Additional medicines that had not been ordered but have been supplied middot D a m a g e d b r o k e n o r p oor quality medicines middot Any other discrepancies

The purchase invoices are an important aspect to be considered The invoiced documents should be signed and filed for reference as per the Drugs and Cosmetics Act and retained for at least 3years

If the wholesaler supplies medicines as an emergency without a bill or against a delivery challan

middot The supplies should be checked for integrity and inspected for damage middot The details of supplies received should be recorded middot The supplier should be asked t o send the bill as early as possible middot When the bill is received it should be checked against the details recorded and anomalies if any should be reported to the supplier

To keep a track of the received stock maintaining a S t o c k R e c o r d C a r d c a n b e very useful The entries in the stock record card can be made while checking the stock received STOCK BIN in the stores should have Stock record card

Maintaining a stock card for every product may not be very practical for a retail pharmacy however it could be maintained for costly medicines Nowadays it is much more practical and easier to maintain records using computers

The pharmacist should ensure that medicines manufacturedmarketed by a company are received only through an authorized distribution network of that company This is important to prevent spurious and counterfeit drugs from entering the pharmacy

37

2 STORAGE 21 The need for proper storage The storage of medicines and other products is an important requirement of Good Pharmacy Pr actice Appropriate storage of medicines is essential -

middot bullTo ensure that the potency is maintained middot bullTo prevent deteriorationspoilagedegradation middot bullTo ensuremaintain physical integrity

To ascertain that the quality and safety is maintained throughout their shelf life Storage requirements need to be considered on 2 aspects

a) Integrity of medicines Medicines should be stored in such a way so as to maintain their integrity and potency middot Maintain the right temperature required middot Protect from excessive humidity middot Keep medicines away from direct sunlight middot Protect from pests and rodents

b) Physical location middot Should be easy to locate middot Accessible middot Orderlysystematically placed

2 2 D i f f e r e n t p a t t e r n s o f s t o r a g e The pharmacist could follow any of the different patterns of storage The pattern of stora ge should be selected in such a way that it facilitates speedy and efficient dispensing of medicines

The pattern of storage could vary with each pharmacy experience usual practiceroutine of staff and the person-in charge and also depending on space av ailable turnover etc (i) The medicines could be stored c o m p a n y w i s e ie the medicines manufactured by one company should be grouped together and kept in one place Within each company shelfshelves the medicines may be placed in alphabetical order for easy and quick placement and removal Also bottles tubes boxes etc may be segregated within that shelf

38

(ii) The medicines may also be stored in a lphabe t ic al o r de r ie they are placed in order from left to right based on their name The first letter of the name is used to g r o u p t h e m e d i c i n e s t o g e t h e r a n d k e e p t h e m i n o n e l o c a t i o n I n s o m e p h a r m a c i e s a l l t h e strip packing are placed in drawers or boxes in alphabetical order each box or drawer containing strips of one particular alphabet This system ensures that the strips always remain e n c l o s e d i n t h e b o x e s d r a w e r s a n d a r e n o t e x p o s e d t o d u s t T h e d i s a d v a n t a g e i s that it might lead to mix -u p o f strips in the same drawer and it may cause a problem incase of similar looking strips in which case a wrong medicine may be dispensed Secondly cut strips lying around in the drawer may lose their identity if the batch n u m b e r andor expiry date is not seen on the cut portion of the strip

39

(iii) The medicines may be stored according to their therapeutic class ( e g a n t i b i o t i c s anti asthmatics or anti hypertensives) ie the medicines are kept together based on their pharmacological or therapeutic action

(iv) The medicines may be stockedsegregated according to dosage forms eg l i q u i d s (bottles) solid oral dosage forms eye drops rotacaps ointments etc all stored on separate shelves

Always Remember I Storage of prescription medicines should preferably be separate from OTC medicines OTC medicines especially those that a r e a d v e r t i s e d m a y b e d i s p l a y e d f o r c l i e n t s t o select or to ask questions about [OTC-O v e r t h e c o u n t e r ] II Storage according to temperatures is a must no matter which pattern of storage is followed Also within a particular storage area segregated storage may be maintained In a refrigerator for example medicines may be stored in trays racks and the freezer according to the temperature required

40

Whatever pattern of storage is selected all the personnel should ensure that middot The stocks are stored in an orderly manner middot The medicines are kept back in the same place from where they were removed middot All medicines are arranged neatly once in a while

middot The personnel should be careful while storing the medicines middot They should not throw the medicines haphazardly 23 Different means of storage

middot Within each temperature and security zone medicines must be stored so that they are easily accessible and protected against damage

middot Basic means of storage include shelves racks and drawers middot To prevent dust from entering the shelvesracks it is ideal to have glass

shutterssliding glass doors This can however be disadvantageous because accessibilityspeed is hampered in removing a product from the shelf because the glassshuttersliding glass has to be

41

opened m o v e d e v e r y t i m e a p r o d u c t h a s t o b e p i c k e d u p U s e o f a i r c o n d i t i o n e r s f o r t h e p h arm acy with a closed door at the e n t r a n c e o r a n a i r c u r t a i n c a n r e d u c e t h e d u s t problem In such cases the shelvesracks may be left o p e n

bull

middot Direct storage of cartons on the floor should be avoided because besides being an unhealthy practice the contents may also be damaged by moisture bull

middot Store medicines preferably in shelves with glass shutters for visibility middot Closed shelves further prevent dust from going in especially in India where most

pharmacies are located along busy roads middot Some medicines have to be refrigerated or stored in a cool or cold place Having a

refrigerator or two (as per the need of the pharmacy) is essential to store suc h medicines at temperatures mentioned on the label bull

42

Refrigeration middot All cold chain equipment should meet required standards middot Improvement in refrigeration technology has provided frost -free refrigerators

Pharmacists should opt for frost-free refrigerators as they are easy to maintain and protect printed packaging materials Conventional refrigerators may cause water falling from trays below the freezer on medicines stored in the refrigerator thus causing soggy labels

middot bull Frost-free refrigerators also provide separate and large compartments for the freezer portion (required for storing medicines needing sub-z e r o t e m p e r a t u r e ) and the main storage area with separate doors so that opening one door does not disturb the storage temperature in the other compartment

Care should be taken to keep the refrigerator on 24 hours a day It should not be switched off after working hours It is advisable to have an inverter connected to the refrigerator so that the refrigerator re mains working even when there is a power outage

middot The refrigerator door should be closed tightly middot The refrigerator door should not be left open for too long middot Space should be left between medicines stored in a refrigerator to allow air to

circulate middot The ref rigerator should be placed about an arms length away from the wall

This will increase air circulation thus not affecting the cooling within the refrigerator

middot Vaccines should not be stored on refrigerator door shelves as they are exposed to warmer temperatures each time the door is opened Vaccines should always be stored on the middle shelves of the refrigerator

middot Refrigerated medicines should not be left out of the refrigerator for more than a few minutes

43

middot Consumable products like juices energy drinks e t c s h o u l d n o t b e s t o r e d a l o n g with medicines in refrigerators If required they may be kept in a separate refrigerator

middot An adequate number of refrigerators should be planned to store the entire stocks requiring refrigerated storage

middot Adequate procedures should be followed for defrosting cleaning and maintenance of refrigerators

middot Icefreeze packs should be kept in the freezer compartment so that they can be used for transporting cold temperature medicines The packs can be given to clients along with the medicines requiring cold temperature storage so that the temperature is maintained till the client reaches home and can then put the medicines in a refrigerator) Freezer packs can also be used to keep medicines temporarily in case there is a power outage or refrigerator breakdown

Activity

Prepare a SOP (Standard operating procedure chart) for cleaning a refrigerator Discuss it with your staff finalize its maintenance once a month through AMC -A n n u a l Maintenance contract CMC - Comprehensive maintenance contract and put it up on the pharmacy refrigerator Put the Purchase Order details name of manufacturer Phone of Service Engineer and a register to login the Machine service and down timeService reports may be maintained properly

Refrigerator monitoring and maintenance

middot bullIt is important to carry out routine monitoring and maintenance of the refrigerators and to organize an effective repair system

middot bullThe temperature in the refrigerator must be monitored and recorded routinely at least once a day

middot Any breakdown must be reco rded including the period during which the medicines were exposed to uncontrolled temperatures Medicines may then be kept or discarded depending on the problem guidelines or the manufacturers advice

middot Cold chain monitor cards and devices in or on packages that change color or otherwise alert staff to potential damage assist in monitoring (These are likely to be introduced in India soon)

middot It is essential to have a contingency plan in place before a refrigerator breaks down An arrangement can be made to move the contents to a private refrigerator elsewhere in the community or to obtain a regular supply of ice packs until the defect is rectified

Put filled water bottles in the bottom half of the refrigerator door in order to provide cooling in the refri g e r a t o r w h e n t h e r e i s a p o w e r o u t a g e T h i s m i g h t t a k e c a r e o f t h e temperature when there is no current for a couple of hours If the power outage is expected to last for several hours special arrangements such as an inverter UPS have to be made to keep the refrigerator constantly running in the absence of electricity middot Defrost the refrigerator in case of excessive ice formation and preferably at regular

intervals Keep a record of the same

44

2 4 T e m p e r a t u r e c l i m a t i c c o n d i t i o n s

i) Temperature control middot The medicines in a pharmacy need to be stored at appropriate temperatures to

maintain their stability middot An air-conditioned environment where temperature can be controlled is

recommended for pharmacies Air conditioning offers the option of setting the t e m p e rature as per requirements

middot bullIt is ideal to have an air conditioner to maintain the temperature below 25 C as most medicines require storage below this temperature Secondly this temperature is pleasing to both the staff and the visiting customers too

middot In the absence of an air conditioner circulating fans may be used middot This need is felt even more in certain parts of India where temperatures soar above 45

C and some areas where it falls to sub zero temperatures In such cases temperature maintenance is essential to prevent deterioration of medicines due to unnecessary exposure to drastic temperature fluctuations

middot This need is felt even more in certain parts of India where temperatures soar above 45 C and some areas where it falls to sub zero temperat u r e s I n s u c h c a s e s temperature maintenance is essential to prevent deterioration of medicines due to unnecessary exposure to drastic temperature fluctuations

i i ) Humidity or moisture control Moisture or humidity can adversely affect the stability of me dicines such as tablets capsules powders

45

Gelatin capsules become soft and swell on absorption of moisture The drug content of tablets may undergo surface hydrolysis The presence of moisture may encourage the growth of microbes It is therefore essential to control humidity

To reduce the effect of humidity the following suggestions may be followed -middot Open the windows to allow air circulation Use a fan to circulate fresh (outside) air middot In humid climate a dehumidifier is useful for preventing mo i s t u r e d a m a g e ( i n t h e absence of an air conditioner) middot For bulk containers of tabletscapsules do not keep the container open for a long time and replace the lid or closure immediately after taking out the required number of medicines for dispensing middot Do not allow the medicines to touch the floor or the walls The walls may be damp and may cause moisture absorption damaging the product

middot Calibrated thermometers and manometers can be used to detect temperature and humidity in the pharmacy

middot Periodici t y of checking the temperature should be fixed middot The climatic conditions should be recorded and documented middot Temperature charts should be available for ready reference

Documentation is one of the core activities for achieving and maintaining quality It is one of the most essential components of validation Temperatures in various areas

46

including refrigerators should be recorded at a predetermined periodicity usually daily at the hottest time of the day and such documents should be preserved i i i ) Storage conditions A number of storage conditions are mentioned on the labels of medicinal products These conditions have to be properly interpreted and appropriately complied with

According to the Drugs and Cosmetics Rules 1945

1 The term cool place means a place having a temperature between 10 C and 25 C

2 The term cold place means a place having a temperature not exceeding 8 C In case of storage conditions for specific products please refer to Schedule P The Drugs and Cosmetic Rules 1 9 4 5

The Indian Pharmacopoeia specifies the following storage conditions -

Wherever the condition for storage is not specified medicines may be stored under normal temperature In a country like India however where normal temperatures soar to h i gh temperatures it is recommended that medicines be stored in a cool place

Activity Prepare a list of the storage requirements mentioned on the label of about 20 products in your pharmacy and check if the temperature is maintained

47

25 Special Storage o f s u p p l i e s If the product has no special instructions normal storage conditions apply This means storage in dry clean w e l l -ventilated premises at temperatures of +15 C to +25 C or depending on the climate up to +30 C (WHO1990) Storage instructions are product specific Different brands of the same generic drug may have different storage requirements as they may have different packaging or formulations It is essential to follow the product manufacturers storage instructions to the maximum extent possible Less stable medicines must be stored in specific conditions to maintain their quality or potency

The following products require special storage facilities

middot Products that must be kept frozen (usually vaccines and sera) middot Products sensitive to h eat an d r e q uir in g r e f r ig e r a tio n ( +2 C to +8 C) middot Products that have reduced shelf life at uncontrolled room temperature and need

mechanical ventilation or air conditioning middot Flammable products that require separate fireproof premises middot Products prone to theft o r m i s u s e

Products needing storage in a controlled environment -

The usable shelf life of the following products may be reduced if stored at uncontrolled humidity or at room temperature in hot climates -

middot Some injectables (eg adrenaline) Most injectable preparations are less stable than solid oral forms (tablets and capsules) Injectable preparations in solution are particularly unstable Many injections must be protected from light as well as heat

middot Intravenous fluids (particularly if packed in p lastic containers) middot Some suppositories pessaries creams and ointments These products may melt at

temperatures greater than 30 C Once this happens it is not advisable to use them because the active ingredient in the formula may get unevenly distributed

middot Products containing rubber latex cellulose or some plastics Condoms most sterile disposable medical devices and surgical products such as syringes needles and catheters require protection from excessive humidity and strong light and heat Any o f these conditions may make products brittle stained amp unusable Sterility cannot be assumed if packaging is damaged

In hot climates these products should be stored in the coolest place possible preferably with air conditioning or air circulation fans

48

Products needing freezing or refrigeration-middot Vaccines blood products and many other medicines lose potency if kept even for a

brief period at temperatures outside the recommended range For these products the cold chain must be maintained at every stage of the distribution system

middot Freezing is as damaging as high temperatures for some products including injectable contraceptives ergometrine insulin adrenaline and the DPT DT TT and Hepatitis B vaccines Such products therefore sho uld not be allowed to freeze (not be kept in the freezer compartment)

middot Short periods at room temperature (during transportation or local distribution for instance) may be acceptable for many products (such as ergometrine a n d i n s u l i n ) e v e n t h o u g h s u c h e x posure can to some extent reduce shelf life Other items such as vaccines should always be transported in cold boxes

Storage of insulin injections-

middot Insulin should always be stored in a refrigerator at the recommended temperature of 2 -8 C

middot Insulin should not be kept in the freezer compartment of the refrigerator middot Insulin should ideally be stored horizontally middot It should not be exposed to sunlight or excessive heat middot Insulin suspensions should not be used if the suspension cannot be properly

resuspended due to cake or clump formationbull

Controlled drugs -Narcotics (for example Pethidine injection morphine preparations) and other specified drugs that may be abused are governed by special legislation and regulations The following security measures are suggested in the pharmacy -middot A safe or reinforced double locked cabinet fitted with a light (preferably with a red

bulb) that comes on when the door is opened

49

middot A special register recording details of each receipt or issue with 2 signatures physi cal counting of medicines after each entry and signatures at handover takeover

middot Independent audit (by supervisors and drug inspectors)

Products prone to theft abuse or misuse -

Some medicinesproducts are particularly prone to theft abuse or misuse These include expensive medicines (eg insulin) certain antibiotics and products prone to abuse or misuse like psychotropics etc

Such medicinesproducts should be stored adequately They require stricter record keeping and more frequent stock taki ng than others Periodic audits should be carried out to check for consumption against actual recorded use (registers prescription records stock records etc) to expose any theft or misuse bull26 Storage and stability of medicines Medicines are not stab le indefinitely They are stable for a specific period of time sometimes for a brief period Poor storage conditions accelerate the drug degradation (decomposition) Temperature light and moisture are the most important contributing factors for drug instability It is important to identify and be aware of the potential for instability There is a need to comply with storage requirements to ensure quality medicines for patients It is also important to offer advice to patients too about appropriate storage o f medicines at home The dispensing label should state the storage condition required and be backed up by a verbal reminder especially where special storage is required bull

50

In case stability and storage problems are seen with formulations they should be reported immediately to the representative of the manufacturer and taken out of circulation till the stability problems have been resolved

The pharmacist can easily detect stability problems when products show change in appearance color odor settling of the product contents breaking of emulsions melting of creams oozing of contents from the containers and any such physical changes

3 STOCK CONTROL AND EXPIRY MONITORING 3 1 S t o c k C o n t r o l For economic reasons pharmacists do not like to have stock on their shelves for long periods of time The aim should always be to keep stock at a level that will just meet demand Normally most manufactured medicines have a long shelf life Even then it is essential that there is efficient stock rot ation so that the older stock is used first It is also a good practice to check the expiry date as an integral part of the dispensing process When short shelf life products are involved stock levels may have to be modified to prevent medicines regularl y expiring on the shelves

32 Stock rotation and expiry monitoring In order to avoid accumulation of expired and obsolete stock medicines should be stored and issued according to the following guidelines -middot The stock control system must record the ex p i r y d a t e a n d t h e d a t e o f r e c e i p t middot Stock must be stored so that earliest expiring batches are picked and issued first middot The First In First Out (FIFO) system - In this system the stock which is received

first is sold first This system however may not be useful for pharmacies because most of the stocks carry an expiry date For pharmacies the FEFO system is more practical

51

middot The First Expiry First Out (FEFO) system - In this system the stock having an earlier expiry is sold first The stock with longer shelf life should be placed farthest to the back (or at the bottom in case o f sta c k e d b oxe s) T h is is pa r tic u la r ly impor ta n t with products that have short shelf lives such as vaccines some vitamins antibiotics etc and reduces losses due to expiry

middot E x p i r y dates should be noted on the stock record upon receipt Stock nearing expiry should not be accepted unless it can be used before expiry

Computerization and expiry monitoring In the pharmacy computerization facilitates both checking stocks and expiry mo nitoring and helps-bullbullKeeping a check on products nearing expiry bullbullKeeping a check on non- moving and slow moving products bullbullTo facilitate the removal of medicines nearing expiry from shelves in time to send them back to the wholesaler or supplier

Periodic checking for expiry The expiry date for medicinal products is a critical aspect in pharmaceutical dispensing and due importance should be given to it Periodic checking for expiry of medicines will ensure that the patient will never receive products that have crossed their expiry date During periodical checking of expiry the personnel involved should remove medicines that are nearing expiry bullbullIn -house threshold periods should be set and followed for retrieval of such medicines from the shelves bullbullSuch medicines should be stored separately These should either be dispensed immediately (thus ensuring that they are used before the expiry date) o r t h e y s h o u l d b e returned to the suppliers bullbullA separate area should be designated (cupboard or shelf)marked[FROZEN ZONE] which is adequately marked EXPIRED GOODS- NOT FOR SALE to store all expired stocks FROZEN ZONE

52

Remember Expired medicines are a NATIONAL WASTE So stock only what you can sell Avoid expiries save precious medicines for the nation

Treatment and disposing of expired medicines bullbullProcedures need to be in place for the treatment of expired medicines bullbullThe expired medicines need to be collected and be sent back to the supplier or company for appropriate disposal bullbullRecords must be maintained for expired medicines and how they are disposed off bullbullIn case of medicines that are not returnable to suppliers procedures for disposal need to be followed by the pharmacy in conjunction with the FDA The following procedure can be followed if medicines cannot be returned to suppliers ( T h e b a s i c p h i l o s o p h y of appropriate disposal is to prevent their re- circulation and use) bullbullC u t t h e c o n t ainer in such a manner that the label is also cut In case of tablets and c a p s u l e s d e s t r o y them by disposing them in a bucket of water bullbullUse landfill procedures (deep burial into the ground as per stipulations of Medical Waste Disposal Act prevalent in the respective state) bullbullPour the liquids into the sink and wash away with sufficient quantity of water bullbullKeep a record of such disposal with full details of medicines destroyed Although these measures are usually adopted care has to be taken with such tr e a t m e n t a s studies have shown that flushing of medicines has resulted in tracessmall quantities of medicines being found in waterways and groundwater having potential health and environmental effects

4 O T H E R A S P E C T S 41 Design of storage areas The following important factors need to be considered in design of storage areas -middot The retail outlets in hot areas in summers should be air-conditioned Similarly in

a r e a s o f e x t r e m e c o l d t h e p r e m i s e s w o u l d r e q u i r e w a r m i n g e s p e c i a l l y i n w i n t e r s t o maintain cool temperatures The placement of air -conditioners and heating devices should be such that medicines are not directly exposed to the cold or heat

middot Due consideration should be given to storage requirements of formulations while designing shelves and cupboards in retail outlets Sufficient shelf height should be provided so that all liquid products can be stored vertically As far as possible the shelves should be covered with glass panels to protect medicines from dust and p r e v e n t r a p i d f l u c t u a t i o n s i n temperature

middot Medicines should be stored according to the storage instructions on the labels bullIt is ideal to have a door at the pharmacy entrance to prevent dust from coming in as well as reduceprevent cooled air from going out This may not however be considered feasiblepracticable by many pharmacy owners for fear that clients may not enter the pharmacy because the door may act as a barrier An air curtain is a good alternative to a door

middot There should be minimal direct sunlight falling on the products Particular consideration should be given to premises directly facing the sun

middot bullThe arrangement of lighting in the interior of the premises should also be in a manner that the lights are not focused on the products It has been shown that light causes not only chemical damage but also can catalyze physical changes like moisture uptak e by the products Care should be taken to ensure that only diffused light falls on them

53

middot As far as possible provision should be made for a temperature and humidity indicator device in a pharmacy These devices are now easily available

middot Stability studies o f m e d i c i n e s p a c k e d i n b l i s t e r s h a v e r e v e a l e d t h a t i f t h e s e a r e exposed to light they tend to absorb moisture It is therefore necessary to store them in suitable cartons so that the blisters are not exposed to light Pharmacists should do this even if the manufacturer has not provided cartons

middot Light and temperature sensitive products should not be stored on counters where the light is intense or direct and there is no protection from temperature and humidity

42 Cleaning and maintenance i) Cleaning of storage areas

The storage areas of the pharmacy should be cleaned periodically and cleanliness should be maintained at all times The Standard Operating Procedure for cleaning should be designed and followed accordingly Schedules for cleanups should be laid down and adequate cleaning equipment should be made available

Tips for maintaining cleanliness middot Provide clean pieces of cloth for wiping at various locations in the pharmacy

Replace with clean cloth at regular intervals middot Keep separate pieces of cloth for floors shelves and medicines middot Use a disinfectant andor soap solution to clean floors middot Ensure removal of dust and prevent accumulation of dirt middot Ensure removal of cobwebs middot Use a vacuum cleaner for cleaning areas not easily reachable middot T a k e c a r e t h at breakages are handled and cleared effectively middot Observe the factors leading to waste generation in the pharmacy and take appropriate

measures to tackle the problem middot Record all cleaning procedures performed and maintain all the documents required

For ex a m p l e -bullbullThe floor of the pharmacy may be swept with a broom and swabbed with soap water every morning bullbullThe floor may be swabbed with a disinfectant every week bullbullThe entire premises including shelves and cupboards may be cleaned with a cloth (to remove dust and to check for medicines approaching expiry date or expired medicines) every three months bullbullAll the steps followed should be r e c o r d e d

The floor shelves drawers have to be cleaned and a check should be kept on dust cobwebs spillages due to breakage etc It is therefore essential to have SOPs for cleaning laying down cleaning frequencies allotting responsibilities and maintaining a daily record in the logbook to document all these activities

54

While cleaning dust settled on dosage forms like bottles tubes etc should be removed Before dispensing the products should also be wiped to remove any dust settled during storage

For refrigerators bullbullDefrosting and cleaning should be done at regular intervals bullbullSwitch off the refrigerator while cleaning bullbullCleaning should be done quickly and stocks put back immediately

i i ) Pest control Pests are a serious problem in India where insects reptiles and rodents (eg cockroaches l i z a r d s r a t s s i l v e r f i s h (Deemak - in Hindi ) etc) may find access to the pharmacy storage areas Insects like ants and borer ants may often attack wood in the pharmacy causing d am ag e to shelves cupboardsPest c ontr o l in a p h a r m a c y c a n b e a d i f f i c u l t t a s k b u t t o avoid possible contamination and physical damage to stock it is necessary to keep pests out of the pharmacy premisesPest control measures should be implemented with proper p r e c a u t i o n s t a k i n g u t m o s t c a r e t o a v o i d contamination of medicines

55

Th e following pest control measures c a n be ta ke n f r om tim e to tim e -bullbullRat bait and traps can be placed at various locations bullbullInsecticutors can be used on a permanent basis bullbullInsecticidal sprays and repellants can be used from time to time

i i i ) Fire precautions

Combustible trash such as cartons boxes and other packing waste must not be allowed to accumulate in the store Waste should be deposited in appropriate waste bins and be d i s p o s e d o f f o n a d a i l y b a s i s

F i re detection and fire fighting equipment must be maintained and regularly inspected The pharmacy personnel should receive adequate training in fire fighting techniques and emergency actionFire prevention measures should include a prominently displayed ldquoNoSmokingrdquo sign careful handling and disposal of combustible waste materials and checking of electrical connections at regular intervals

iv) Security middot Doors shutters of the pharmacy should be strong and be fitted with secure locks middot Counters should be designed so that unauthorized personnelclients do not have

access to areas where prescription medicines are stored Access to such areas should be restricted to the pharmacy staff

middot All the pharmacy staff handling supplies should be accountable for their ac t i o n s

56

middot bullSpecial care must be taken in case of Schedule X and manufactured drugs (under NDPS Act) Such medicines should be kept under lock and key and the key should be kept with the Chief Pharmacist or i n h i s a b s e n c e t h e s e n i o r p h a r m a c i s t

v) Breakagespillage and damaged product Products that have been damagedspoiled during storage and handling spillages and broken glassware should be disposed off according to procedures laid down by the pharmacy Broken and damaged products s h o u l d b e p l a c e d i n a segregated area to be returned to the supplier

vi) Inspection Senior staff should inspect all pharmacy areas regularly The shelves and drawers should b e c h e c k e d d a i l y f o r signs of pests and dust Ceiling and walls should be checked for dirt and cobwebs Stock should be checked on a regular basis for deterioration due to climatic conditions

43 Product recalls Products found to be defective should be quickly recalled (withdrawn from the market) The instructions are generally issued either by the manufacturer or the regulatory agency The level of recall is determined by both the degree of risk and the extent of distribution of the product and in India is mainly directed at the distribution chain

On receiving the details of the defective substandard spurious batchbatches of a medicine to be recalled from the manufacturer or the stockist or the FDA the pharmacy should immediately check if the particular b a t c h i s i n s t o c k a n d i f s o s u s p e n d i t s s a l e immediately

Similarly if the regulatory authority in the country bans a particular medicine or FDC the pharmacy should immediately check and remove all the different brands of that particular medicine under consideration

The details of medicines and their batches to be recalled should be available in the q u a r a n t i n e a r e a w h e r e stocks are received and checked This is to ensure that such medicines do not come into the pharmacy

middot The pharmacy should develop SOPs for recall of medicines middot The pharmacy staff should be immediately informed about such medicines and

the details should be displayed in writing in a prominent place in the pharmacy middot Rapid action helps avoid unnecessary exposure to such medicines once the

problem has been d e t e c t e d middot The progress of the recall procedure in the pharmacy should be monitored every

few days to ensure complete compliance middot All stocks of the recalled products should be stored separately from the saleable

stock These can be stored in the expiry cupboard segregated from the expired goods and be appropriately labeled ldquoRecal l e d G o o d s - Not for Salerdquo

The supplier should be notified and asked to replace defective products middot All the details of the procedures followed should be duly recorded in a Recall

Register maintained specially for the purpose The register should include d etails such as -middot Date of the recall middot Nam e of the product

57

bullbull

middot Details of the product (name of manufacturer batch number expiry date) middot Nu m b er of units purchased sold a n d sto c k in ha nd middot Reason for recall middot Nam e of the supplier to whom produc ts w e r e returned along with the date and quantity middot Name and signature of the designated personnel carrying out the recall procedure and recording details middot Name and signature of the chief pharmacist verifying the recall procedures and recording details 4 4 Returned medicines

Medicines may be returned to the pharmacy by clients due to the following reasons -bull

bullbull Unused medicines bullbull Course not completed bullbull Therapy changed by doctor bullbull Side effects experienced by patient bull

bullbull DamagedDefective medicines bullbull Missing or defaced label bullbull Missing tablets in a stripblister bullbull Leakage in bottles bullbull Leakage in strips bull

bullbull Expired medicines

Appropriate SOPs should be framed and followed for their acceptancerefusal and disposal middot bull For unused medicines returned by clients the p harmacy personnel should verify

that these were purchased from their pharmacy They should then be checked for integrity of the packing the dosage form and the expiry date and verified with the client whether they were stored in appropriate conditions This again is at the discretion of each pharmacy

middot The damageddefective medicines returned to the pharmacy should be taken back and stored separately Existing stock of the same product should be checked for similar defects

middot Expired medicines should be accepted from clients at the discretion of the pharmacist and be immediately shifted to the expired goods cupboard These can be stored segregated from the pharmacys own expired goods and be appropriately labelled ldquoExpired Goods returned by clients- Not For Salerdquo

It is advisable not to accept returned medicines requiring cold chain storage (refrigeration) because it cannot be ensured that the cold chain was maintained when the medicines were in the hands of the patientclient middot Appropriate adjustments in t he stocks should be made for medicines

returnedexchanged to update the inventory middot The medicines should then be returned to the respective shelves middot A lsquoReturned Goodsrsquo register needs to be maintained to record all details of returned

medicines

R egister should include such details as-

58

middot N a m e o f t h e p a t i e n t middot Nam e of the product and quantity r e tu r n e d middot Product details such as the batch number and expiry date middot Condition in which received middot Reason for returning products middot Compensatory measures taken wi t h r e s p e c t t o c l i e n t middot Action taken with respect to product middot Name and signature of the personnel accepting the returned medicines and recording details middot Name and signature of the chief pharmacist verifying the recorded details

What the pharmacist would have learnt from this module The storage of medicines is a critical factor in the distribution cycle bullbull Stocks received by the pharmacy should be quarantined in a separate area and necessary checks s h o u ld be performed to ascertain the qua lity a nd quantity of stocks received bullbull Whatever pattern and means of storage used the products should be stored so as to maintain their potency and integrity bullbull Storage conditions should be monitored and maintained on a regular basis bullbull Optimum stock levels should be maintained and regularly monitored for expiry bullbull The design of storage areas should facilitate appropriate storage of medicines bullbull Cleanliness should be maintained in the pharmacy bullbull Adequate measures should be taken in case of returned medicines and recalled products

Optimum storage of medicines is mandatory whether at the distribution stage at the pharmacy or ultimately within the homes of patients The pharmacist has an important r o l e t o p l a y i n t h e s t o r a g e o f m e d i c i n e s i n m a i n t a i n i n g d r u g p o t ency and efficacy and thus facilitating optimum therapeutic benefits Good Pharmacy Practice - IPA -CDSCO - WHO Appendix I Quality Assurance Templates of letters for use if found not of Standard Quality [Frozen and expired goods ]

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated To Name of the Supplier with address

Sub Not of Standard Quality GoMP-Supply of Drugs and medicines-(Codename) Return of Stocks to the Suppliers-reg(New drug policy 2009) Previous letterinvoice ref Sl No Drug Code Drug name

Manufacturing date Expiry date

Supplier address

B a t c h n o

The above items of PO nodated was drawn by the Drug Inspector (Place) on (______________date) as a statutory sampling and declared ldquoNot of Standard

59

Qualityrdquo on -(______________date) by the Government Analyst for the following reasons

- ldquoThe product sample do not confirm to IP specification for (Drug codename with respect to the content of drugrdquo

- ldquoThe product has already been blacklisted by TNMSC on -(______________date) for the failure of (quantity) of batches of drug codenamerdquo

As per the clause of the te nde r d oc um e nt ldquo I f the sa mple s d o not c onf o r m to statutory standardsthe tenderer will be liable for relevant action under the existing laws and the entire stock in such batch should be taken back by the tenderer within a period of 30 days o f t h e r e c e i p t o f t h e l e t t e r f r o m t h e v e n u e

The stock shall be taken back at the expenses of the tendererthe Procurement Authority have the right to destroy such Not of Standard Quality if the tenderer does not take back the goods within the stipulated time

The Procuring Authority will arrange to destroy the Not of Standard Quality drugs within 90 days after the expiry of 30 days mentioned above without further notice and shall also collect demurrage charges calculated at the rate of 2 per week on the value of the drugs rejected till such destructionrdquo

Hence we regret to inform you that you will have to take back the stocks available of the abovesaid batch at your own cost from the drug stores where you have supplied the above batch

Kindly acknowledge the receipt of this reference at once

P r o c u r e m e n t A u t h o r i t y Seal and Stamp

Copy to Ref No dated

1 ) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated13082010

To

Sub Frozen Drugs-ordered to return to the Suppliers-reg(New drug policy 2009) Previous letterinvoice ref

The following products which were earlier frozen have now been ordered to return to suppliers directly with permission from the State drug Authority In this regard the suppliers have been instructed to take back their failed batch from the drug store of the stores Hence you are now instructed to return the following failed batches to the suppliers by obtaining proper authorization letter and acknowledgements from them

60

Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

Kindly acknowledge the receipt of this reference at once

Procurement Authority Seal and Stamp

Copy to

Ref No dated 2) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated14092010

To

Sub Frozen Drugs-ordered to return to the Suppliers- for issue of gate pass after verification reg(New drug policy 2009) Previous letterinvoice ref

The following products which were earlier frozen have now been released Hence they may be issued Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

Kindly acknowledge the receipt of this reference at once

Procurement Authority Seal and Stamp

Copy to

61

Ref No dated 3) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated

To

Sub Stop instruction-reg(New drug policy 2009) Previous letterinvoice ref

Until further instructions stop issue all the batches of the following item Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

You must intimate the available stock in the stores of the said batch Number to the Procurement Authority immediately Also retrieve quantity if already issued

Procurement Authority Seal and Stamp

Copy to

Ref No dated 4) HOD Procurement Office of

62

Appendix II Material handling in drug stores

Rack approx rates and dimensions

S No

Item Description UOM Approx Rate

1 MEDIUM DUTY RACK SIZE 2900 H X 3090 W X 800 D IN MM (AS PER SPECIFICATION)

Each 2499800

2 MEDIUM DUTY RACK ADD ON UNIT FOR SIZE OF SR NO2

Each 2243100

To locate a Box no 3 Rack no 14 in row3

SAMPLE OF RACK no Bin numbering -------------- S a y R K 1 4 R o w 3 B o x 1 6

SAMPLE LAYOUT of RACKS in a Drug Stores

63

Sample of another warehouse of distribution warehouse system

64

65

Slotted Angle racks with bin cards

66

Plastic Pallets

Plastic pallets ar e l i g h t w e i g h t l o w- c ost and exceed industry standards for strength and durability

NOTE A pallet has bottom deckboards (see sketch) A skid does not have bottom

67

deckboards

Battery Operated Stacker

Electric Stacker Ehh (Manual Push Type) - Manual drive - Lifting electrically with Battery 12 V 88 Ah - For loading and un-loading of trucks - Battery and loading device built - in - Battery charge gauge and charging current gauge Simple and Easy Operation - Lifting and Lowering electrically direct on steering arm - Pulling and pushing through steering arm - Electrically operated relief valve on hydraulic aggregate Safe Operation - Emergency Off Switch - Constant lowering speed - Protection through lowering brake valve - Overload protection through overload brake valve - Load chains covered preventing pinching threat - Electrically interlocking during loading process - Secured battery compartment opens upwardly - Stable buffering of the steering arm in upright position - In accordance with EWG Guidelines 89 240 - In accordance with VBG 12b Prevention of Accidents

Pallet Truck [ Top ]

68

----------------------------------------------------------------------------------------------------------------------------

For Transport Of All Goods On Pallets Safe and Easy Operation - through single hand operation Lifting moving

lowering with steering handle - neutral position of the hydraulic possible - overload pressure relief valve Long Service Life - robust co n s t r u c t i o n

- special hardened axles - hardened chromium plated ram - maintenance free Easy Maneuverability - through rubber steering rollers - nylon fork rollers

A h a n d t r o l l e y

69

Trolley with plastic bins for several items del ivery

70

Digital Weighing balances

Balances amp Scales EF Seriers Precision Electronic Balance

71

1

Ice lined Refrigerators

600 litres refrigrator

72

Walk in cooler

vacuum cleaner

73

INDEX

Sr No P a r t i c u l a r s P a g e

1 S T O R A G E A N D S T O C K M A N A G E M E N T 4

1 Quarantine and checking of stocks 11 Quarantine area 12 Checks to be carried out on new stocks

2 S t o r a g e 21 Need for proper storage 22 Different patterns of storage 23 Different means of storage 24 Temperatureclimatic conditions 25 Special storage of supplies 26 Storage and stability of medicines

3 Stock Control and Expiry Monitoring 31 Stock control 32 Stock rotation and expi r y m o n i t o r i n g

4 Other aspects of storage 41 Design of a storage area 42 Cleaning and maintenance 43 Product recalls 44 Returned goods

2 A p p e n d i x 1 Templates of letters for use if found not of Standard Quality [Frozen and expired goods ]

Frozen Drugs-ordered to return to the Suppliers-reg(New drug policy 2009)

Frozen Drugs-ordered to return to the Suppliers- for issue of gate pass after verification reg(New drug policy 2009) Stop instruction-reg(New drug policy

2009) Appendix II Material handling in drug stores

31

3 PROCUREMENT ndash Government Order Relating to

the Management of Stores

(Reproduced for reference material on basic

procedure in decentralized system followed by

Health facilities in 1977)

54

F L O W C H A R T S f o r a BI R D S E Y E V I E W o f

P R O C U R E M E N T

5 5

ACQUISITION OF STORES 6 1

PLACING OF ORDERS 6 2

RECEIPT OF STORES 6 2

CUSTODY 6 3

ISSUE OF STORES Maintenance of Stock Books

6 3

PROCEDURE OF INDENTING FOR WARD amp OTHER SECTIONS OF THE INSTITUTION

6 4

HOW OFTEN TO INDENT 6 5

EMERGENT INDENT 6 5

HOW TO INDENT 6 5

KEEPING OF RECORDS IN WARDS A N D S E C T I O N S

6 6

ACCOUNTABILITY OF DRUGS BROUGHT BY THE PATIENT OR RECEIVED IN DON A T I O N BY T H E WARDSECTION _IN - CHARGE

6 7

RESPONSIBILITY OF STORES AT VARIOUS LEVELS

6 7

DISTRIBUTION OF MEDICINES FROM OUTDOOR DEPARTMENT

6 7

LOSS BREAKAGE DAMAGE ETC 6 8

PROCEDURE FOR WRITING OFF STORES 6 9

DISPOSAL OF WRITTEN OFF ARTICLES 7 1

FORMATS TO BE USED 7 3 - 81

32

STORAGE AND STOCK MANAGEMENT The expiry periods of pharmaceutical products have meaning only if the products are stored under proper conditions otherwise products are likely to lose their potency before the actual date of expiry

A pharmacist is a vital link in the distribution chain for pharmaceutical products The medicinal products remain for a long period during the distribution cycle at the wholesaler and at retail pharmacies It is therefore very important to maintain proper storage conditions in these units

Every community pharmacy however large or s mall needs to store and manage its medicine stocks effectively There must be systems to ensure

middot bullbull Secure storage middot bullbull Clean and correct environmental conditions during storage middot bullbull Accurate and effective record keeping middot bullbull Effective stock rotation and expiry monitoring middot bullbull Effective fire and theft prevention middot bullbull Effective rodent pest control

For easier un derstanding this module has been divided into the following sections

1 Quarantine and checking of stocks 11 Quarantine area 12 Checks to be carried out on new stocks

2 S t o r a g e 21 Need for proper storage 22 Different patterns of storage 23 Different means of storage 24 Temperatureclimatic conditions 25 Special storage of supplies 26 Storage and stability of medicines

3 Stock Control and Expiry Monitoring 31 Stock control 3 2 S t o c k r o t a t i o n a n d e x p i r y m o n i t o r i n g

4 Other aspects of s t o r a g e 41 Design of a storage area 42 Cleaning and maintenance 43 Product recalls 44 Returned goods

33

1 QUARANTINE AND CHECKING OF STOCKS

11 Quarantine Area D r u g S t o r e pharmacies receive stoc k s f r o m su pplie r s a c c or d ing to pur c h a se o r d e r s T he stock that is received must be visually checked for quality and quantity The stocks must be kept in a separate area until the checking is done to avoid intermixing with existing stock This necessitates the presence of a separate area within the pharmacy w h e r e i n t h e storage and other checking of stocks can be performed This area is called the QUARANTINE AREA This area should be marked and identified adequately to distinguish it from other areas

The area may be marked using different means 1 ) A s m a l l board saying Quarantine on a separate table used exclusively if it is in the middle 2) A board on the wall if the table on which the quarantine stock is placed is against the wall

middot Stock received from wholesalers should be immediately transferred t o t h e Quarantine Area

middot In the Quarantine area the stock may be stored on racks shelves or in cupboards to prevent ingress of moisture dirt and other contaminants

middot Regular stocks from the pharmacy should not be left kept in the quarantine area Special care has to be taken in case of refrigerated medicines supplied by the suppliers so tha t the y do not remain in the quarantine area for long periods of time They should be immediately checked on receipt and transferred to areas for refrigerated storage s o a s to maintain the cold chain bull

Advantages of having a separate Quarantine Area middot Avoids cross mixing of newly arrived stock from existing stock till it is checked middot Lays stress on checking the quality of the stock received middot S to ck checking ensures t hat defective andor expired goods do not enter the storage areas

34

bullbull

bullbull

12 Checks to be carried out on new stock

Unpacking and checking stock

Supplies received should be unpacked and checked in the quarantine area Staff doing the checks should be adequatel y trained in what they have to check when stock arrives

Checking should be seen not simply as counting the units received but as a part of the quality assurance system bullThis should include middot Visually inspecting the packaging middot Checking the integrity of containers middot V erifying the completeness and leg ibility of la b e ls ( a ppr o ve d dr u g name strength any special storage instructions and expiry date)

bull

The expiry dat e should be checked to ensure that there is adequate shelf life remaining

Supplies should be individually checked using a checklist 35

Checklists

36

The wholesaler supplying the product should be notified immediately in case of any discrepancies ( and the details should be recorded in a register) and sent in a written format to the supplier It should include middot Missing boxes or cartons middot O p en tampered boxes or cartons middot Missing supplies middot Differences in the actual quantity and the quantity shown on the packing middot Additional medicines that had not been ordered but have been supplied middot D a m a g e d b r o k e n o r p oor quality medicines middot Any other discrepancies

The purchase invoices are an important aspect to be considered The invoiced documents should be signed and filed for reference as per the Drugs and Cosmetics Act and retained for at least 3years

If the wholesaler supplies medicines as an emergency without a bill or against a delivery challan

middot The supplies should be checked for integrity and inspected for damage middot The details of supplies received should be recorded middot The supplier should be asked t o send the bill as early as possible middot When the bill is received it should be checked against the details recorded and anomalies if any should be reported to the supplier

To keep a track of the received stock maintaining a S t o c k R e c o r d C a r d c a n b e very useful The entries in the stock record card can be made while checking the stock received STOCK BIN in the stores should have Stock record card

Maintaining a stock card for every product may not be very practical for a retail pharmacy however it could be maintained for costly medicines Nowadays it is much more practical and easier to maintain records using computers

The pharmacist should ensure that medicines manufacturedmarketed by a company are received only through an authorized distribution network of that company This is important to prevent spurious and counterfeit drugs from entering the pharmacy

37

2 STORAGE 21 The need for proper storage The storage of medicines and other products is an important requirement of Good Pharmacy Pr actice Appropriate storage of medicines is essential -

middot bullTo ensure that the potency is maintained middot bullTo prevent deteriorationspoilagedegradation middot bullTo ensuremaintain physical integrity

To ascertain that the quality and safety is maintained throughout their shelf life Storage requirements need to be considered on 2 aspects

a) Integrity of medicines Medicines should be stored in such a way so as to maintain their integrity and potency middot Maintain the right temperature required middot Protect from excessive humidity middot Keep medicines away from direct sunlight middot Protect from pests and rodents

b) Physical location middot Should be easy to locate middot Accessible middot Orderlysystematically placed

2 2 D i f f e r e n t p a t t e r n s o f s t o r a g e The pharmacist could follow any of the different patterns of storage The pattern of stora ge should be selected in such a way that it facilitates speedy and efficient dispensing of medicines

The pattern of storage could vary with each pharmacy experience usual practiceroutine of staff and the person-in charge and also depending on space av ailable turnover etc (i) The medicines could be stored c o m p a n y w i s e ie the medicines manufactured by one company should be grouped together and kept in one place Within each company shelfshelves the medicines may be placed in alphabetical order for easy and quick placement and removal Also bottles tubes boxes etc may be segregated within that shelf

38

(ii) The medicines may also be stored in a lphabe t ic al o r de r ie they are placed in order from left to right based on their name The first letter of the name is used to g r o u p t h e m e d i c i n e s t o g e t h e r a n d k e e p t h e m i n o n e l o c a t i o n I n s o m e p h a r m a c i e s a l l t h e strip packing are placed in drawers or boxes in alphabetical order each box or drawer containing strips of one particular alphabet This system ensures that the strips always remain e n c l o s e d i n t h e b o x e s d r a w e r s a n d a r e n o t e x p o s e d t o d u s t T h e d i s a d v a n t a g e i s that it might lead to mix -u p o f strips in the same drawer and it may cause a problem incase of similar looking strips in which case a wrong medicine may be dispensed Secondly cut strips lying around in the drawer may lose their identity if the batch n u m b e r andor expiry date is not seen on the cut portion of the strip

39

(iii) The medicines may be stored according to their therapeutic class ( e g a n t i b i o t i c s anti asthmatics or anti hypertensives) ie the medicines are kept together based on their pharmacological or therapeutic action

(iv) The medicines may be stockedsegregated according to dosage forms eg l i q u i d s (bottles) solid oral dosage forms eye drops rotacaps ointments etc all stored on separate shelves

Always Remember I Storage of prescription medicines should preferably be separate from OTC medicines OTC medicines especially those that a r e a d v e r t i s e d m a y b e d i s p l a y e d f o r c l i e n t s t o select or to ask questions about [OTC-O v e r t h e c o u n t e r ] II Storage according to temperatures is a must no matter which pattern of storage is followed Also within a particular storage area segregated storage may be maintained In a refrigerator for example medicines may be stored in trays racks and the freezer according to the temperature required

40

Whatever pattern of storage is selected all the personnel should ensure that middot The stocks are stored in an orderly manner middot The medicines are kept back in the same place from where they were removed middot All medicines are arranged neatly once in a while

middot The personnel should be careful while storing the medicines middot They should not throw the medicines haphazardly 23 Different means of storage

middot Within each temperature and security zone medicines must be stored so that they are easily accessible and protected against damage

middot Basic means of storage include shelves racks and drawers middot To prevent dust from entering the shelvesracks it is ideal to have glass

shutterssliding glass doors This can however be disadvantageous because accessibilityspeed is hampered in removing a product from the shelf because the glassshuttersliding glass has to be

41

opened m o v e d e v e r y t i m e a p r o d u c t h a s t o b e p i c k e d u p U s e o f a i r c o n d i t i o n e r s f o r t h e p h arm acy with a closed door at the e n t r a n c e o r a n a i r c u r t a i n c a n r e d u c e t h e d u s t problem In such cases the shelvesracks may be left o p e n

bull

middot Direct storage of cartons on the floor should be avoided because besides being an unhealthy practice the contents may also be damaged by moisture bull

middot Store medicines preferably in shelves with glass shutters for visibility middot Closed shelves further prevent dust from going in especially in India where most

pharmacies are located along busy roads middot Some medicines have to be refrigerated or stored in a cool or cold place Having a

refrigerator or two (as per the need of the pharmacy) is essential to store suc h medicines at temperatures mentioned on the label bull

42

Refrigeration middot All cold chain equipment should meet required standards middot Improvement in refrigeration technology has provided frost -free refrigerators

Pharmacists should opt for frost-free refrigerators as they are easy to maintain and protect printed packaging materials Conventional refrigerators may cause water falling from trays below the freezer on medicines stored in the refrigerator thus causing soggy labels

middot bull Frost-free refrigerators also provide separate and large compartments for the freezer portion (required for storing medicines needing sub-z e r o t e m p e r a t u r e ) and the main storage area with separate doors so that opening one door does not disturb the storage temperature in the other compartment

Care should be taken to keep the refrigerator on 24 hours a day It should not be switched off after working hours It is advisable to have an inverter connected to the refrigerator so that the refrigerator re mains working even when there is a power outage

middot The refrigerator door should be closed tightly middot The refrigerator door should not be left open for too long middot Space should be left between medicines stored in a refrigerator to allow air to

circulate middot The ref rigerator should be placed about an arms length away from the wall

This will increase air circulation thus not affecting the cooling within the refrigerator

middot Vaccines should not be stored on refrigerator door shelves as they are exposed to warmer temperatures each time the door is opened Vaccines should always be stored on the middle shelves of the refrigerator

middot Refrigerated medicines should not be left out of the refrigerator for more than a few minutes

43

middot Consumable products like juices energy drinks e t c s h o u l d n o t b e s t o r e d a l o n g with medicines in refrigerators If required they may be kept in a separate refrigerator

middot An adequate number of refrigerators should be planned to store the entire stocks requiring refrigerated storage

middot Adequate procedures should be followed for defrosting cleaning and maintenance of refrigerators

middot Icefreeze packs should be kept in the freezer compartment so that they can be used for transporting cold temperature medicines The packs can be given to clients along with the medicines requiring cold temperature storage so that the temperature is maintained till the client reaches home and can then put the medicines in a refrigerator) Freezer packs can also be used to keep medicines temporarily in case there is a power outage or refrigerator breakdown

Activity

Prepare a SOP (Standard operating procedure chart) for cleaning a refrigerator Discuss it with your staff finalize its maintenance once a month through AMC -A n n u a l Maintenance contract CMC - Comprehensive maintenance contract and put it up on the pharmacy refrigerator Put the Purchase Order details name of manufacturer Phone of Service Engineer and a register to login the Machine service and down timeService reports may be maintained properly

Refrigerator monitoring and maintenance

middot bullIt is important to carry out routine monitoring and maintenance of the refrigerators and to organize an effective repair system

middot bullThe temperature in the refrigerator must be monitored and recorded routinely at least once a day

middot Any breakdown must be reco rded including the period during which the medicines were exposed to uncontrolled temperatures Medicines may then be kept or discarded depending on the problem guidelines or the manufacturers advice

middot Cold chain monitor cards and devices in or on packages that change color or otherwise alert staff to potential damage assist in monitoring (These are likely to be introduced in India soon)

middot It is essential to have a contingency plan in place before a refrigerator breaks down An arrangement can be made to move the contents to a private refrigerator elsewhere in the community or to obtain a regular supply of ice packs until the defect is rectified

Put filled water bottles in the bottom half of the refrigerator door in order to provide cooling in the refri g e r a t o r w h e n t h e r e i s a p o w e r o u t a g e T h i s m i g h t t a k e c a r e o f t h e temperature when there is no current for a couple of hours If the power outage is expected to last for several hours special arrangements such as an inverter UPS have to be made to keep the refrigerator constantly running in the absence of electricity middot Defrost the refrigerator in case of excessive ice formation and preferably at regular

intervals Keep a record of the same

44

2 4 T e m p e r a t u r e c l i m a t i c c o n d i t i o n s

i) Temperature control middot The medicines in a pharmacy need to be stored at appropriate temperatures to

maintain their stability middot An air-conditioned environment where temperature can be controlled is

recommended for pharmacies Air conditioning offers the option of setting the t e m p e rature as per requirements

middot bullIt is ideal to have an air conditioner to maintain the temperature below 25 C as most medicines require storage below this temperature Secondly this temperature is pleasing to both the staff and the visiting customers too

middot In the absence of an air conditioner circulating fans may be used middot This need is felt even more in certain parts of India where temperatures soar above 45

C and some areas where it falls to sub zero temperatures In such cases temperature maintenance is essential to prevent deterioration of medicines due to unnecessary exposure to drastic temperature fluctuations

middot This need is felt even more in certain parts of India where temperatures soar above 45 C and some areas where it falls to sub zero temperat u r e s I n s u c h c a s e s temperature maintenance is essential to prevent deterioration of medicines due to unnecessary exposure to drastic temperature fluctuations

i i ) Humidity or moisture control Moisture or humidity can adversely affect the stability of me dicines such as tablets capsules powders

45

Gelatin capsules become soft and swell on absorption of moisture The drug content of tablets may undergo surface hydrolysis The presence of moisture may encourage the growth of microbes It is therefore essential to control humidity

To reduce the effect of humidity the following suggestions may be followed -middot Open the windows to allow air circulation Use a fan to circulate fresh (outside) air middot In humid climate a dehumidifier is useful for preventing mo i s t u r e d a m a g e ( i n t h e absence of an air conditioner) middot For bulk containers of tabletscapsules do not keep the container open for a long time and replace the lid or closure immediately after taking out the required number of medicines for dispensing middot Do not allow the medicines to touch the floor or the walls The walls may be damp and may cause moisture absorption damaging the product

middot Calibrated thermometers and manometers can be used to detect temperature and humidity in the pharmacy

middot Periodici t y of checking the temperature should be fixed middot The climatic conditions should be recorded and documented middot Temperature charts should be available for ready reference

Documentation is one of the core activities for achieving and maintaining quality It is one of the most essential components of validation Temperatures in various areas

46

including refrigerators should be recorded at a predetermined periodicity usually daily at the hottest time of the day and such documents should be preserved i i i ) Storage conditions A number of storage conditions are mentioned on the labels of medicinal products These conditions have to be properly interpreted and appropriately complied with

According to the Drugs and Cosmetics Rules 1945

1 The term cool place means a place having a temperature between 10 C and 25 C

2 The term cold place means a place having a temperature not exceeding 8 C In case of storage conditions for specific products please refer to Schedule P The Drugs and Cosmetic Rules 1 9 4 5

The Indian Pharmacopoeia specifies the following storage conditions -

Wherever the condition for storage is not specified medicines may be stored under normal temperature In a country like India however where normal temperatures soar to h i gh temperatures it is recommended that medicines be stored in a cool place

Activity Prepare a list of the storage requirements mentioned on the label of about 20 products in your pharmacy and check if the temperature is maintained

47

25 Special Storage o f s u p p l i e s If the product has no special instructions normal storage conditions apply This means storage in dry clean w e l l -ventilated premises at temperatures of +15 C to +25 C or depending on the climate up to +30 C (WHO1990) Storage instructions are product specific Different brands of the same generic drug may have different storage requirements as they may have different packaging or formulations It is essential to follow the product manufacturers storage instructions to the maximum extent possible Less stable medicines must be stored in specific conditions to maintain their quality or potency

The following products require special storage facilities

middot Products that must be kept frozen (usually vaccines and sera) middot Products sensitive to h eat an d r e q uir in g r e f r ig e r a tio n ( +2 C to +8 C) middot Products that have reduced shelf life at uncontrolled room temperature and need

mechanical ventilation or air conditioning middot Flammable products that require separate fireproof premises middot Products prone to theft o r m i s u s e

Products needing storage in a controlled environment -

The usable shelf life of the following products may be reduced if stored at uncontrolled humidity or at room temperature in hot climates -

middot Some injectables (eg adrenaline) Most injectable preparations are less stable than solid oral forms (tablets and capsules) Injectable preparations in solution are particularly unstable Many injections must be protected from light as well as heat

middot Intravenous fluids (particularly if packed in p lastic containers) middot Some suppositories pessaries creams and ointments These products may melt at

temperatures greater than 30 C Once this happens it is not advisable to use them because the active ingredient in the formula may get unevenly distributed

middot Products containing rubber latex cellulose or some plastics Condoms most sterile disposable medical devices and surgical products such as syringes needles and catheters require protection from excessive humidity and strong light and heat Any o f these conditions may make products brittle stained amp unusable Sterility cannot be assumed if packaging is damaged

In hot climates these products should be stored in the coolest place possible preferably with air conditioning or air circulation fans

48

Products needing freezing or refrigeration-middot Vaccines blood products and many other medicines lose potency if kept even for a

brief period at temperatures outside the recommended range For these products the cold chain must be maintained at every stage of the distribution system

middot Freezing is as damaging as high temperatures for some products including injectable contraceptives ergometrine insulin adrenaline and the DPT DT TT and Hepatitis B vaccines Such products therefore sho uld not be allowed to freeze (not be kept in the freezer compartment)

middot Short periods at room temperature (during transportation or local distribution for instance) may be acceptable for many products (such as ergometrine a n d i n s u l i n ) e v e n t h o u g h s u c h e x posure can to some extent reduce shelf life Other items such as vaccines should always be transported in cold boxes

Storage of insulin injections-

middot Insulin should always be stored in a refrigerator at the recommended temperature of 2 -8 C

middot Insulin should not be kept in the freezer compartment of the refrigerator middot Insulin should ideally be stored horizontally middot It should not be exposed to sunlight or excessive heat middot Insulin suspensions should not be used if the suspension cannot be properly

resuspended due to cake or clump formationbull

Controlled drugs -Narcotics (for example Pethidine injection morphine preparations) and other specified drugs that may be abused are governed by special legislation and regulations The following security measures are suggested in the pharmacy -middot A safe or reinforced double locked cabinet fitted with a light (preferably with a red

bulb) that comes on when the door is opened

49

middot A special register recording details of each receipt or issue with 2 signatures physi cal counting of medicines after each entry and signatures at handover takeover

middot Independent audit (by supervisors and drug inspectors)

Products prone to theft abuse or misuse -

Some medicinesproducts are particularly prone to theft abuse or misuse These include expensive medicines (eg insulin) certain antibiotics and products prone to abuse or misuse like psychotropics etc

Such medicinesproducts should be stored adequately They require stricter record keeping and more frequent stock taki ng than others Periodic audits should be carried out to check for consumption against actual recorded use (registers prescription records stock records etc) to expose any theft or misuse bull26 Storage and stability of medicines Medicines are not stab le indefinitely They are stable for a specific period of time sometimes for a brief period Poor storage conditions accelerate the drug degradation (decomposition) Temperature light and moisture are the most important contributing factors for drug instability It is important to identify and be aware of the potential for instability There is a need to comply with storage requirements to ensure quality medicines for patients It is also important to offer advice to patients too about appropriate storage o f medicines at home The dispensing label should state the storage condition required and be backed up by a verbal reminder especially where special storage is required bull

50

In case stability and storage problems are seen with formulations they should be reported immediately to the representative of the manufacturer and taken out of circulation till the stability problems have been resolved

The pharmacist can easily detect stability problems when products show change in appearance color odor settling of the product contents breaking of emulsions melting of creams oozing of contents from the containers and any such physical changes

3 STOCK CONTROL AND EXPIRY MONITORING 3 1 S t o c k C o n t r o l For economic reasons pharmacists do not like to have stock on their shelves for long periods of time The aim should always be to keep stock at a level that will just meet demand Normally most manufactured medicines have a long shelf life Even then it is essential that there is efficient stock rot ation so that the older stock is used first It is also a good practice to check the expiry date as an integral part of the dispensing process When short shelf life products are involved stock levels may have to be modified to prevent medicines regularl y expiring on the shelves

32 Stock rotation and expiry monitoring In order to avoid accumulation of expired and obsolete stock medicines should be stored and issued according to the following guidelines -middot The stock control system must record the ex p i r y d a t e a n d t h e d a t e o f r e c e i p t middot Stock must be stored so that earliest expiring batches are picked and issued first middot The First In First Out (FIFO) system - In this system the stock which is received

first is sold first This system however may not be useful for pharmacies because most of the stocks carry an expiry date For pharmacies the FEFO system is more practical

51

middot The First Expiry First Out (FEFO) system - In this system the stock having an earlier expiry is sold first The stock with longer shelf life should be placed farthest to the back (or at the bottom in case o f sta c k e d b oxe s) T h is is pa r tic u la r ly impor ta n t with products that have short shelf lives such as vaccines some vitamins antibiotics etc and reduces losses due to expiry

middot E x p i r y dates should be noted on the stock record upon receipt Stock nearing expiry should not be accepted unless it can be used before expiry

Computerization and expiry monitoring In the pharmacy computerization facilitates both checking stocks and expiry mo nitoring and helps-bullbullKeeping a check on products nearing expiry bullbullKeeping a check on non- moving and slow moving products bullbullTo facilitate the removal of medicines nearing expiry from shelves in time to send them back to the wholesaler or supplier

Periodic checking for expiry The expiry date for medicinal products is a critical aspect in pharmaceutical dispensing and due importance should be given to it Periodic checking for expiry of medicines will ensure that the patient will never receive products that have crossed their expiry date During periodical checking of expiry the personnel involved should remove medicines that are nearing expiry bullbullIn -house threshold periods should be set and followed for retrieval of such medicines from the shelves bullbullSuch medicines should be stored separately These should either be dispensed immediately (thus ensuring that they are used before the expiry date) o r t h e y s h o u l d b e returned to the suppliers bullbullA separate area should be designated (cupboard or shelf)marked[FROZEN ZONE] which is adequately marked EXPIRED GOODS- NOT FOR SALE to store all expired stocks FROZEN ZONE

52

Remember Expired medicines are a NATIONAL WASTE So stock only what you can sell Avoid expiries save precious medicines for the nation

Treatment and disposing of expired medicines bullbullProcedures need to be in place for the treatment of expired medicines bullbullThe expired medicines need to be collected and be sent back to the supplier or company for appropriate disposal bullbullRecords must be maintained for expired medicines and how they are disposed off bullbullIn case of medicines that are not returnable to suppliers procedures for disposal need to be followed by the pharmacy in conjunction with the FDA The following procedure can be followed if medicines cannot be returned to suppliers ( T h e b a s i c p h i l o s o p h y of appropriate disposal is to prevent their re- circulation and use) bullbullC u t t h e c o n t ainer in such a manner that the label is also cut In case of tablets and c a p s u l e s d e s t r o y them by disposing them in a bucket of water bullbullUse landfill procedures (deep burial into the ground as per stipulations of Medical Waste Disposal Act prevalent in the respective state) bullbullPour the liquids into the sink and wash away with sufficient quantity of water bullbullKeep a record of such disposal with full details of medicines destroyed Although these measures are usually adopted care has to be taken with such tr e a t m e n t a s studies have shown that flushing of medicines has resulted in tracessmall quantities of medicines being found in waterways and groundwater having potential health and environmental effects

4 O T H E R A S P E C T S 41 Design of storage areas The following important factors need to be considered in design of storage areas -middot The retail outlets in hot areas in summers should be air-conditioned Similarly in

a r e a s o f e x t r e m e c o l d t h e p r e m i s e s w o u l d r e q u i r e w a r m i n g e s p e c i a l l y i n w i n t e r s t o maintain cool temperatures The placement of air -conditioners and heating devices should be such that medicines are not directly exposed to the cold or heat

middot Due consideration should be given to storage requirements of formulations while designing shelves and cupboards in retail outlets Sufficient shelf height should be provided so that all liquid products can be stored vertically As far as possible the shelves should be covered with glass panels to protect medicines from dust and p r e v e n t r a p i d f l u c t u a t i o n s i n temperature

middot Medicines should be stored according to the storage instructions on the labels bullIt is ideal to have a door at the pharmacy entrance to prevent dust from coming in as well as reduceprevent cooled air from going out This may not however be considered feasiblepracticable by many pharmacy owners for fear that clients may not enter the pharmacy because the door may act as a barrier An air curtain is a good alternative to a door

middot There should be minimal direct sunlight falling on the products Particular consideration should be given to premises directly facing the sun

middot bullThe arrangement of lighting in the interior of the premises should also be in a manner that the lights are not focused on the products It has been shown that light causes not only chemical damage but also can catalyze physical changes like moisture uptak e by the products Care should be taken to ensure that only diffused light falls on them

53

middot As far as possible provision should be made for a temperature and humidity indicator device in a pharmacy These devices are now easily available

middot Stability studies o f m e d i c i n e s p a c k e d i n b l i s t e r s h a v e r e v e a l e d t h a t i f t h e s e a r e exposed to light they tend to absorb moisture It is therefore necessary to store them in suitable cartons so that the blisters are not exposed to light Pharmacists should do this even if the manufacturer has not provided cartons

middot Light and temperature sensitive products should not be stored on counters where the light is intense or direct and there is no protection from temperature and humidity

42 Cleaning and maintenance i) Cleaning of storage areas

The storage areas of the pharmacy should be cleaned periodically and cleanliness should be maintained at all times The Standard Operating Procedure for cleaning should be designed and followed accordingly Schedules for cleanups should be laid down and adequate cleaning equipment should be made available

Tips for maintaining cleanliness middot Provide clean pieces of cloth for wiping at various locations in the pharmacy

Replace with clean cloth at regular intervals middot Keep separate pieces of cloth for floors shelves and medicines middot Use a disinfectant andor soap solution to clean floors middot Ensure removal of dust and prevent accumulation of dirt middot Ensure removal of cobwebs middot Use a vacuum cleaner for cleaning areas not easily reachable middot T a k e c a r e t h at breakages are handled and cleared effectively middot Observe the factors leading to waste generation in the pharmacy and take appropriate

measures to tackle the problem middot Record all cleaning procedures performed and maintain all the documents required

For ex a m p l e -bullbullThe floor of the pharmacy may be swept with a broom and swabbed with soap water every morning bullbullThe floor may be swabbed with a disinfectant every week bullbullThe entire premises including shelves and cupboards may be cleaned with a cloth (to remove dust and to check for medicines approaching expiry date or expired medicines) every three months bullbullAll the steps followed should be r e c o r d e d

The floor shelves drawers have to be cleaned and a check should be kept on dust cobwebs spillages due to breakage etc It is therefore essential to have SOPs for cleaning laying down cleaning frequencies allotting responsibilities and maintaining a daily record in the logbook to document all these activities

54

While cleaning dust settled on dosage forms like bottles tubes etc should be removed Before dispensing the products should also be wiped to remove any dust settled during storage

For refrigerators bullbullDefrosting and cleaning should be done at regular intervals bullbullSwitch off the refrigerator while cleaning bullbullCleaning should be done quickly and stocks put back immediately

i i ) Pest control Pests are a serious problem in India where insects reptiles and rodents (eg cockroaches l i z a r d s r a t s s i l v e r f i s h (Deemak - in Hindi ) etc) may find access to the pharmacy storage areas Insects like ants and borer ants may often attack wood in the pharmacy causing d am ag e to shelves cupboardsPest c ontr o l in a p h a r m a c y c a n b e a d i f f i c u l t t a s k b u t t o avoid possible contamination and physical damage to stock it is necessary to keep pests out of the pharmacy premisesPest control measures should be implemented with proper p r e c a u t i o n s t a k i n g u t m o s t c a r e t o a v o i d contamination of medicines

55

Th e following pest control measures c a n be ta ke n f r om tim e to tim e -bullbullRat bait and traps can be placed at various locations bullbullInsecticutors can be used on a permanent basis bullbullInsecticidal sprays and repellants can be used from time to time

i i i ) Fire precautions

Combustible trash such as cartons boxes and other packing waste must not be allowed to accumulate in the store Waste should be deposited in appropriate waste bins and be d i s p o s e d o f f o n a d a i l y b a s i s

F i re detection and fire fighting equipment must be maintained and regularly inspected The pharmacy personnel should receive adequate training in fire fighting techniques and emergency actionFire prevention measures should include a prominently displayed ldquoNoSmokingrdquo sign careful handling and disposal of combustible waste materials and checking of electrical connections at regular intervals

iv) Security middot Doors shutters of the pharmacy should be strong and be fitted with secure locks middot Counters should be designed so that unauthorized personnelclients do not have

access to areas where prescription medicines are stored Access to such areas should be restricted to the pharmacy staff

middot All the pharmacy staff handling supplies should be accountable for their ac t i o n s

56

middot bullSpecial care must be taken in case of Schedule X and manufactured drugs (under NDPS Act) Such medicines should be kept under lock and key and the key should be kept with the Chief Pharmacist or i n h i s a b s e n c e t h e s e n i o r p h a r m a c i s t

v) Breakagespillage and damaged product Products that have been damagedspoiled during storage and handling spillages and broken glassware should be disposed off according to procedures laid down by the pharmacy Broken and damaged products s h o u l d b e p l a c e d i n a segregated area to be returned to the supplier

vi) Inspection Senior staff should inspect all pharmacy areas regularly The shelves and drawers should b e c h e c k e d d a i l y f o r signs of pests and dust Ceiling and walls should be checked for dirt and cobwebs Stock should be checked on a regular basis for deterioration due to climatic conditions

43 Product recalls Products found to be defective should be quickly recalled (withdrawn from the market) The instructions are generally issued either by the manufacturer or the regulatory agency The level of recall is determined by both the degree of risk and the extent of distribution of the product and in India is mainly directed at the distribution chain

On receiving the details of the defective substandard spurious batchbatches of a medicine to be recalled from the manufacturer or the stockist or the FDA the pharmacy should immediately check if the particular b a t c h i s i n s t o c k a n d i f s o s u s p e n d i t s s a l e immediately

Similarly if the regulatory authority in the country bans a particular medicine or FDC the pharmacy should immediately check and remove all the different brands of that particular medicine under consideration

The details of medicines and their batches to be recalled should be available in the q u a r a n t i n e a r e a w h e r e stocks are received and checked This is to ensure that such medicines do not come into the pharmacy

middot The pharmacy should develop SOPs for recall of medicines middot The pharmacy staff should be immediately informed about such medicines and

the details should be displayed in writing in a prominent place in the pharmacy middot Rapid action helps avoid unnecessary exposure to such medicines once the

problem has been d e t e c t e d middot The progress of the recall procedure in the pharmacy should be monitored every

few days to ensure complete compliance middot All stocks of the recalled products should be stored separately from the saleable

stock These can be stored in the expiry cupboard segregated from the expired goods and be appropriately labeled ldquoRecal l e d G o o d s - Not for Salerdquo

The supplier should be notified and asked to replace defective products middot All the details of the procedures followed should be duly recorded in a Recall

Register maintained specially for the purpose The register should include d etails such as -middot Date of the recall middot Nam e of the product

57

bullbull

middot Details of the product (name of manufacturer batch number expiry date) middot Nu m b er of units purchased sold a n d sto c k in ha nd middot Reason for recall middot Nam e of the supplier to whom produc ts w e r e returned along with the date and quantity middot Name and signature of the designated personnel carrying out the recall procedure and recording details middot Name and signature of the chief pharmacist verifying the recall procedures and recording details 4 4 Returned medicines

Medicines may be returned to the pharmacy by clients due to the following reasons -bull

bullbull Unused medicines bullbull Course not completed bullbull Therapy changed by doctor bullbull Side effects experienced by patient bull

bullbull DamagedDefective medicines bullbull Missing or defaced label bullbull Missing tablets in a stripblister bullbull Leakage in bottles bullbull Leakage in strips bull

bullbull Expired medicines

Appropriate SOPs should be framed and followed for their acceptancerefusal and disposal middot bull For unused medicines returned by clients the p harmacy personnel should verify

that these were purchased from their pharmacy They should then be checked for integrity of the packing the dosage form and the expiry date and verified with the client whether they were stored in appropriate conditions This again is at the discretion of each pharmacy

middot The damageddefective medicines returned to the pharmacy should be taken back and stored separately Existing stock of the same product should be checked for similar defects

middot Expired medicines should be accepted from clients at the discretion of the pharmacist and be immediately shifted to the expired goods cupboard These can be stored segregated from the pharmacys own expired goods and be appropriately labelled ldquoExpired Goods returned by clients- Not For Salerdquo

It is advisable not to accept returned medicines requiring cold chain storage (refrigeration) because it cannot be ensured that the cold chain was maintained when the medicines were in the hands of the patientclient middot Appropriate adjustments in t he stocks should be made for medicines

returnedexchanged to update the inventory middot The medicines should then be returned to the respective shelves middot A lsquoReturned Goodsrsquo register needs to be maintained to record all details of returned

medicines

R egister should include such details as-

58

middot N a m e o f t h e p a t i e n t middot Nam e of the product and quantity r e tu r n e d middot Product details such as the batch number and expiry date middot Condition in which received middot Reason for returning products middot Compensatory measures taken wi t h r e s p e c t t o c l i e n t middot Action taken with respect to product middot Name and signature of the personnel accepting the returned medicines and recording details middot Name and signature of the chief pharmacist verifying the recorded details

What the pharmacist would have learnt from this module The storage of medicines is a critical factor in the distribution cycle bullbull Stocks received by the pharmacy should be quarantined in a separate area and necessary checks s h o u ld be performed to ascertain the qua lity a nd quantity of stocks received bullbull Whatever pattern and means of storage used the products should be stored so as to maintain their potency and integrity bullbull Storage conditions should be monitored and maintained on a regular basis bullbull Optimum stock levels should be maintained and regularly monitored for expiry bullbull The design of storage areas should facilitate appropriate storage of medicines bullbull Cleanliness should be maintained in the pharmacy bullbull Adequate measures should be taken in case of returned medicines and recalled products

Optimum storage of medicines is mandatory whether at the distribution stage at the pharmacy or ultimately within the homes of patients The pharmacist has an important r o l e t o p l a y i n t h e s t o r a g e o f m e d i c i n e s i n m a i n t a i n i n g d r u g p o t ency and efficacy and thus facilitating optimum therapeutic benefits Good Pharmacy Practice - IPA -CDSCO - WHO Appendix I Quality Assurance Templates of letters for use if found not of Standard Quality [Frozen and expired goods ]

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated To Name of the Supplier with address

Sub Not of Standard Quality GoMP-Supply of Drugs and medicines-(Codename) Return of Stocks to the Suppliers-reg(New drug policy 2009) Previous letterinvoice ref Sl No Drug Code Drug name

Manufacturing date Expiry date

Supplier address

B a t c h n o

The above items of PO nodated was drawn by the Drug Inspector (Place) on (______________date) as a statutory sampling and declared ldquoNot of Standard

59

Qualityrdquo on -(______________date) by the Government Analyst for the following reasons

- ldquoThe product sample do not confirm to IP specification for (Drug codename with respect to the content of drugrdquo

- ldquoThe product has already been blacklisted by TNMSC on -(______________date) for the failure of (quantity) of batches of drug codenamerdquo

As per the clause of the te nde r d oc um e nt ldquo I f the sa mple s d o not c onf o r m to statutory standardsthe tenderer will be liable for relevant action under the existing laws and the entire stock in such batch should be taken back by the tenderer within a period of 30 days o f t h e r e c e i p t o f t h e l e t t e r f r o m t h e v e n u e

The stock shall be taken back at the expenses of the tendererthe Procurement Authority have the right to destroy such Not of Standard Quality if the tenderer does not take back the goods within the stipulated time

The Procuring Authority will arrange to destroy the Not of Standard Quality drugs within 90 days after the expiry of 30 days mentioned above without further notice and shall also collect demurrage charges calculated at the rate of 2 per week on the value of the drugs rejected till such destructionrdquo

Hence we regret to inform you that you will have to take back the stocks available of the abovesaid batch at your own cost from the drug stores where you have supplied the above batch

Kindly acknowledge the receipt of this reference at once

P r o c u r e m e n t A u t h o r i t y Seal and Stamp

Copy to Ref No dated

1 ) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated13082010

To

Sub Frozen Drugs-ordered to return to the Suppliers-reg(New drug policy 2009) Previous letterinvoice ref

The following products which were earlier frozen have now been ordered to return to suppliers directly with permission from the State drug Authority In this regard the suppliers have been instructed to take back their failed batch from the drug store of the stores Hence you are now instructed to return the following failed batches to the suppliers by obtaining proper authorization letter and acknowledgements from them

60

Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

Kindly acknowledge the receipt of this reference at once

Procurement Authority Seal and Stamp

Copy to

Ref No dated 2) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated14092010

To

Sub Frozen Drugs-ordered to return to the Suppliers- for issue of gate pass after verification reg(New drug policy 2009) Previous letterinvoice ref

The following products which were earlier frozen have now been released Hence they may be issued Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

Kindly acknowledge the receipt of this reference at once

Procurement Authority Seal and Stamp

Copy to

61

Ref No dated 3) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated

To

Sub Stop instruction-reg(New drug policy 2009) Previous letterinvoice ref

Until further instructions stop issue all the batches of the following item Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

You must intimate the available stock in the stores of the said batch Number to the Procurement Authority immediately Also retrieve quantity if already issued

Procurement Authority Seal and Stamp

Copy to

Ref No dated 4) HOD Procurement Office of

62

Appendix II Material handling in drug stores

Rack approx rates and dimensions

S No

Item Description UOM Approx Rate

1 MEDIUM DUTY RACK SIZE 2900 H X 3090 W X 800 D IN MM (AS PER SPECIFICATION)

Each 2499800

2 MEDIUM DUTY RACK ADD ON UNIT FOR SIZE OF SR NO2

Each 2243100

To locate a Box no 3 Rack no 14 in row3

SAMPLE OF RACK no Bin numbering -------------- S a y R K 1 4 R o w 3 B o x 1 6

SAMPLE LAYOUT of RACKS in a Drug Stores

63

Sample of another warehouse of distribution warehouse system

64

65

Slotted Angle racks with bin cards

66

Plastic Pallets

Plastic pallets ar e l i g h t w e i g h t l o w- c ost and exceed industry standards for strength and durability

NOTE A pallet has bottom deckboards (see sketch) A skid does not have bottom

67

deckboards

Battery Operated Stacker

Electric Stacker Ehh (Manual Push Type) - Manual drive - Lifting electrically with Battery 12 V 88 Ah - For loading and un-loading of trucks - Battery and loading device built - in - Battery charge gauge and charging current gauge Simple and Easy Operation - Lifting and Lowering electrically direct on steering arm - Pulling and pushing through steering arm - Electrically operated relief valve on hydraulic aggregate Safe Operation - Emergency Off Switch - Constant lowering speed - Protection through lowering brake valve - Overload protection through overload brake valve - Load chains covered preventing pinching threat - Electrically interlocking during loading process - Secured battery compartment opens upwardly - Stable buffering of the steering arm in upright position - In accordance with EWG Guidelines 89 240 - In accordance with VBG 12b Prevention of Accidents

Pallet Truck [ Top ]

68

----------------------------------------------------------------------------------------------------------------------------

For Transport Of All Goods On Pallets Safe and Easy Operation - through single hand operation Lifting moving

lowering with steering handle - neutral position of the hydraulic possible - overload pressure relief valve Long Service Life - robust co n s t r u c t i o n

- special hardened axles - hardened chromium plated ram - maintenance free Easy Maneuverability - through rubber steering rollers - nylon fork rollers

A h a n d t r o l l e y

69

Trolley with plastic bins for several items del ivery

70

Digital Weighing balances

Balances amp Scales EF Seriers Precision Electronic Balance

71

1

Ice lined Refrigerators

600 litres refrigrator

72

Walk in cooler

vacuum cleaner

73

3 PROCUREMENT ndash Government Order Relating to

the Management of Stores

(Reproduced for reference material on basic

procedure in decentralized system followed by

Health facilities in 1977)

54

F L O W C H A R T S f o r a BI R D S E Y E V I E W o f

P R O C U R E M E N T

5 5

ACQUISITION OF STORES 6 1

PLACING OF ORDERS 6 2

RECEIPT OF STORES 6 2

CUSTODY 6 3

ISSUE OF STORES Maintenance of Stock Books

6 3

PROCEDURE OF INDENTING FOR WARD amp OTHER SECTIONS OF THE INSTITUTION

6 4

HOW OFTEN TO INDENT 6 5

EMERGENT INDENT 6 5

HOW TO INDENT 6 5

KEEPING OF RECORDS IN WARDS A N D S E C T I O N S

6 6

ACCOUNTABILITY OF DRUGS BROUGHT BY THE PATIENT OR RECEIVED IN DON A T I O N BY T H E WARDSECTION _IN - CHARGE

6 7

RESPONSIBILITY OF STORES AT VARIOUS LEVELS

6 7

DISTRIBUTION OF MEDICINES FROM OUTDOOR DEPARTMENT

6 7

LOSS BREAKAGE DAMAGE ETC 6 8

PROCEDURE FOR WRITING OFF STORES 6 9

DISPOSAL OF WRITTEN OFF ARTICLES 7 1

FORMATS TO BE USED 7 3 - 81

32

STORAGE AND STOCK MANAGEMENT The expiry periods of pharmaceutical products have meaning only if the products are stored under proper conditions otherwise products are likely to lose their potency before the actual date of expiry

A pharmacist is a vital link in the distribution chain for pharmaceutical products The medicinal products remain for a long period during the distribution cycle at the wholesaler and at retail pharmacies It is therefore very important to maintain proper storage conditions in these units

Every community pharmacy however large or s mall needs to store and manage its medicine stocks effectively There must be systems to ensure

middot bullbull Secure storage middot bullbull Clean and correct environmental conditions during storage middot bullbull Accurate and effective record keeping middot bullbull Effective stock rotation and expiry monitoring middot bullbull Effective fire and theft prevention middot bullbull Effective rodent pest control

For easier un derstanding this module has been divided into the following sections

1 Quarantine and checking of stocks 11 Quarantine area 12 Checks to be carried out on new stocks

2 S t o r a g e 21 Need for proper storage 22 Different patterns of storage 23 Different means of storage 24 Temperatureclimatic conditions 25 Special storage of supplies 26 Storage and stability of medicines

3 Stock Control and Expiry Monitoring 31 Stock control 3 2 S t o c k r o t a t i o n a n d e x p i r y m o n i t o r i n g

4 Other aspects of s t o r a g e 41 Design of a storage area 42 Cleaning and maintenance 43 Product recalls 44 Returned goods

33

1 QUARANTINE AND CHECKING OF STOCKS

11 Quarantine Area D r u g S t o r e pharmacies receive stoc k s f r o m su pplie r s a c c or d ing to pur c h a se o r d e r s T he stock that is received must be visually checked for quality and quantity The stocks must be kept in a separate area until the checking is done to avoid intermixing with existing stock This necessitates the presence of a separate area within the pharmacy w h e r e i n t h e storage and other checking of stocks can be performed This area is called the QUARANTINE AREA This area should be marked and identified adequately to distinguish it from other areas

The area may be marked using different means 1 ) A s m a l l board saying Quarantine on a separate table used exclusively if it is in the middle 2) A board on the wall if the table on which the quarantine stock is placed is against the wall

middot Stock received from wholesalers should be immediately transferred t o t h e Quarantine Area

middot In the Quarantine area the stock may be stored on racks shelves or in cupboards to prevent ingress of moisture dirt and other contaminants

middot Regular stocks from the pharmacy should not be left kept in the quarantine area Special care has to be taken in case of refrigerated medicines supplied by the suppliers so tha t the y do not remain in the quarantine area for long periods of time They should be immediately checked on receipt and transferred to areas for refrigerated storage s o a s to maintain the cold chain bull

Advantages of having a separate Quarantine Area middot Avoids cross mixing of newly arrived stock from existing stock till it is checked middot Lays stress on checking the quality of the stock received middot S to ck checking ensures t hat defective andor expired goods do not enter the storage areas

34

bullbull

bullbull

12 Checks to be carried out on new stock

Unpacking and checking stock

Supplies received should be unpacked and checked in the quarantine area Staff doing the checks should be adequatel y trained in what they have to check when stock arrives

Checking should be seen not simply as counting the units received but as a part of the quality assurance system bullThis should include middot Visually inspecting the packaging middot Checking the integrity of containers middot V erifying the completeness and leg ibility of la b e ls ( a ppr o ve d dr u g name strength any special storage instructions and expiry date)

bull

The expiry dat e should be checked to ensure that there is adequate shelf life remaining

Supplies should be individually checked using a checklist 35

Checklists

36

The wholesaler supplying the product should be notified immediately in case of any discrepancies ( and the details should be recorded in a register) and sent in a written format to the supplier It should include middot Missing boxes or cartons middot O p en tampered boxes or cartons middot Missing supplies middot Differences in the actual quantity and the quantity shown on the packing middot Additional medicines that had not been ordered but have been supplied middot D a m a g e d b r o k e n o r p oor quality medicines middot Any other discrepancies

The purchase invoices are an important aspect to be considered The invoiced documents should be signed and filed for reference as per the Drugs and Cosmetics Act and retained for at least 3years

If the wholesaler supplies medicines as an emergency without a bill or against a delivery challan

middot The supplies should be checked for integrity and inspected for damage middot The details of supplies received should be recorded middot The supplier should be asked t o send the bill as early as possible middot When the bill is received it should be checked against the details recorded and anomalies if any should be reported to the supplier

To keep a track of the received stock maintaining a S t o c k R e c o r d C a r d c a n b e very useful The entries in the stock record card can be made while checking the stock received STOCK BIN in the stores should have Stock record card

Maintaining a stock card for every product may not be very practical for a retail pharmacy however it could be maintained for costly medicines Nowadays it is much more practical and easier to maintain records using computers

The pharmacist should ensure that medicines manufacturedmarketed by a company are received only through an authorized distribution network of that company This is important to prevent spurious and counterfeit drugs from entering the pharmacy

37

2 STORAGE 21 The need for proper storage The storage of medicines and other products is an important requirement of Good Pharmacy Pr actice Appropriate storage of medicines is essential -

middot bullTo ensure that the potency is maintained middot bullTo prevent deteriorationspoilagedegradation middot bullTo ensuremaintain physical integrity

To ascertain that the quality and safety is maintained throughout their shelf life Storage requirements need to be considered on 2 aspects

a) Integrity of medicines Medicines should be stored in such a way so as to maintain their integrity and potency middot Maintain the right temperature required middot Protect from excessive humidity middot Keep medicines away from direct sunlight middot Protect from pests and rodents

b) Physical location middot Should be easy to locate middot Accessible middot Orderlysystematically placed

2 2 D i f f e r e n t p a t t e r n s o f s t o r a g e The pharmacist could follow any of the different patterns of storage The pattern of stora ge should be selected in such a way that it facilitates speedy and efficient dispensing of medicines

The pattern of storage could vary with each pharmacy experience usual practiceroutine of staff and the person-in charge and also depending on space av ailable turnover etc (i) The medicines could be stored c o m p a n y w i s e ie the medicines manufactured by one company should be grouped together and kept in one place Within each company shelfshelves the medicines may be placed in alphabetical order for easy and quick placement and removal Also bottles tubes boxes etc may be segregated within that shelf

38

(ii) The medicines may also be stored in a lphabe t ic al o r de r ie they are placed in order from left to right based on their name The first letter of the name is used to g r o u p t h e m e d i c i n e s t o g e t h e r a n d k e e p t h e m i n o n e l o c a t i o n I n s o m e p h a r m a c i e s a l l t h e strip packing are placed in drawers or boxes in alphabetical order each box or drawer containing strips of one particular alphabet This system ensures that the strips always remain e n c l o s e d i n t h e b o x e s d r a w e r s a n d a r e n o t e x p o s e d t o d u s t T h e d i s a d v a n t a g e i s that it might lead to mix -u p o f strips in the same drawer and it may cause a problem incase of similar looking strips in which case a wrong medicine may be dispensed Secondly cut strips lying around in the drawer may lose their identity if the batch n u m b e r andor expiry date is not seen on the cut portion of the strip

39

(iii) The medicines may be stored according to their therapeutic class ( e g a n t i b i o t i c s anti asthmatics or anti hypertensives) ie the medicines are kept together based on their pharmacological or therapeutic action

(iv) The medicines may be stockedsegregated according to dosage forms eg l i q u i d s (bottles) solid oral dosage forms eye drops rotacaps ointments etc all stored on separate shelves

Always Remember I Storage of prescription medicines should preferably be separate from OTC medicines OTC medicines especially those that a r e a d v e r t i s e d m a y b e d i s p l a y e d f o r c l i e n t s t o select or to ask questions about [OTC-O v e r t h e c o u n t e r ] II Storage according to temperatures is a must no matter which pattern of storage is followed Also within a particular storage area segregated storage may be maintained In a refrigerator for example medicines may be stored in trays racks and the freezer according to the temperature required

40

Whatever pattern of storage is selected all the personnel should ensure that middot The stocks are stored in an orderly manner middot The medicines are kept back in the same place from where they were removed middot All medicines are arranged neatly once in a while

middot The personnel should be careful while storing the medicines middot They should not throw the medicines haphazardly 23 Different means of storage

middot Within each temperature and security zone medicines must be stored so that they are easily accessible and protected against damage

middot Basic means of storage include shelves racks and drawers middot To prevent dust from entering the shelvesracks it is ideal to have glass

shutterssliding glass doors This can however be disadvantageous because accessibilityspeed is hampered in removing a product from the shelf because the glassshuttersliding glass has to be

41

opened m o v e d e v e r y t i m e a p r o d u c t h a s t o b e p i c k e d u p U s e o f a i r c o n d i t i o n e r s f o r t h e p h arm acy with a closed door at the e n t r a n c e o r a n a i r c u r t a i n c a n r e d u c e t h e d u s t problem In such cases the shelvesracks may be left o p e n

bull

middot Direct storage of cartons on the floor should be avoided because besides being an unhealthy practice the contents may also be damaged by moisture bull

middot Store medicines preferably in shelves with glass shutters for visibility middot Closed shelves further prevent dust from going in especially in India where most

pharmacies are located along busy roads middot Some medicines have to be refrigerated or stored in a cool or cold place Having a

refrigerator or two (as per the need of the pharmacy) is essential to store suc h medicines at temperatures mentioned on the label bull

42

Refrigeration middot All cold chain equipment should meet required standards middot Improvement in refrigeration technology has provided frost -free refrigerators

Pharmacists should opt for frost-free refrigerators as they are easy to maintain and protect printed packaging materials Conventional refrigerators may cause water falling from trays below the freezer on medicines stored in the refrigerator thus causing soggy labels

middot bull Frost-free refrigerators also provide separate and large compartments for the freezer portion (required for storing medicines needing sub-z e r o t e m p e r a t u r e ) and the main storage area with separate doors so that opening one door does not disturb the storage temperature in the other compartment

Care should be taken to keep the refrigerator on 24 hours a day It should not be switched off after working hours It is advisable to have an inverter connected to the refrigerator so that the refrigerator re mains working even when there is a power outage

middot The refrigerator door should be closed tightly middot The refrigerator door should not be left open for too long middot Space should be left between medicines stored in a refrigerator to allow air to

circulate middot The ref rigerator should be placed about an arms length away from the wall

This will increase air circulation thus not affecting the cooling within the refrigerator

middot Vaccines should not be stored on refrigerator door shelves as they are exposed to warmer temperatures each time the door is opened Vaccines should always be stored on the middle shelves of the refrigerator

middot Refrigerated medicines should not be left out of the refrigerator for more than a few minutes

43

middot Consumable products like juices energy drinks e t c s h o u l d n o t b e s t o r e d a l o n g with medicines in refrigerators If required they may be kept in a separate refrigerator

middot An adequate number of refrigerators should be planned to store the entire stocks requiring refrigerated storage

middot Adequate procedures should be followed for defrosting cleaning and maintenance of refrigerators

middot Icefreeze packs should be kept in the freezer compartment so that they can be used for transporting cold temperature medicines The packs can be given to clients along with the medicines requiring cold temperature storage so that the temperature is maintained till the client reaches home and can then put the medicines in a refrigerator) Freezer packs can also be used to keep medicines temporarily in case there is a power outage or refrigerator breakdown

Activity

Prepare a SOP (Standard operating procedure chart) for cleaning a refrigerator Discuss it with your staff finalize its maintenance once a month through AMC -A n n u a l Maintenance contract CMC - Comprehensive maintenance contract and put it up on the pharmacy refrigerator Put the Purchase Order details name of manufacturer Phone of Service Engineer and a register to login the Machine service and down timeService reports may be maintained properly

Refrigerator monitoring and maintenance

middot bullIt is important to carry out routine monitoring and maintenance of the refrigerators and to organize an effective repair system

middot bullThe temperature in the refrigerator must be monitored and recorded routinely at least once a day

middot Any breakdown must be reco rded including the period during which the medicines were exposed to uncontrolled temperatures Medicines may then be kept or discarded depending on the problem guidelines or the manufacturers advice

middot Cold chain monitor cards and devices in or on packages that change color or otherwise alert staff to potential damage assist in monitoring (These are likely to be introduced in India soon)

middot It is essential to have a contingency plan in place before a refrigerator breaks down An arrangement can be made to move the contents to a private refrigerator elsewhere in the community or to obtain a regular supply of ice packs until the defect is rectified

Put filled water bottles in the bottom half of the refrigerator door in order to provide cooling in the refri g e r a t o r w h e n t h e r e i s a p o w e r o u t a g e T h i s m i g h t t a k e c a r e o f t h e temperature when there is no current for a couple of hours If the power outage is expected to last for several hours special arrangements such as an inverter UPS have to be made to keep the refrigerator constantly running in the absence of electricity middot Defrost the refrigerator in case of excessive ice formation and preferably at regular

intervals Keep a record of the same

44

2 4 T e m p e r a t u r e c l i m a t i c c o n d i t i o n s

i) Temperature control middot The medicines in a pharmacy need to be stored at appropriate temperatures to

maintain their stability middot An air-conditioned environment where temperature can be controlled is

recommended for pharmacies Air conditioning offers the option of setting the t e m p e rature as per requirements

middot bullIt is ideal to have an air conditioner to maintain the temperature below 25 C as most medicines require storage below this temperature Secondly this temperature is pleasing to both the staff and the visiting customers too

middot In the absence of an air conditioner circulating fans may be used middot This need is felt even more in certain parts of India where temperatures soar above 45

C and some areas where it falls to sub zero temperatures In such cases temperature maintenance is essential to prevent deterioration of medicines due to unnecessary exposure to drastic temperature fluctuations

middot This need is felt even more in certain parts of India where temperatures soar above 45 C and some areas where it falls to sub zero temperat u r e s I n s u c h c a s e s temperature maintenance is essential to prevent deterioration of medicines due to unnecessary exposure to drastic temperature fluctuations

i i ) Humidity or moisture control Moisture or humidity can adversely affect the stability of me dicines such as tablets capsules powders

45

Gelatin capsules become soft and swell on absorption of moisture The drug content of tablets may undergo surface hydrolysis The presence of moisture may encourage the growth of microbes It is therefore essential to control humidity

To reduce the effect of humidity the following suggestions may be followed -middot Open the windows to allow air circulation Use a fan to circulate fresh (outside) air middot In humid climate a dehumidifier is useful for preventing mo i s t u r e d a m a g e ( i n t h e absence of an air conditioner) middot For bulk containers of tabletscapsules do not keep the container open for a long time and replace the lid or closure immediately after taking out the required number of medicines for dispensing middot Do not allow the medicines to touch the floor or the walls The walls may be damp and may cause moisture absorption damaging the product

middot Calibrated thermometers and manometers can be used to detect temperature and humidity in the pharmacy

middot Periodici t y of checking the temperature should be fixed middot The climatic conditions should be recorded and documented middot Temperature charts should be available for ready reference

Documentation is one of the core activities for achieving and maintaining quality It is one of the most essential components of validation Temperatures in various areas

46

including refrigerators should be recorded at a predetermined periodicity usually daily at the hottest time of the day and such documents should be preserved i i i ) Storage conditions A number of storage conditions are mentioned on the labels of medicinal products These conditions have to be properly interpreted and appropriately complied with

According to the Drugs and Cosmetics Rules 1945

1 The term cool place means a place having a temperature between 10 C and 25 C

2 The term cold place means a place having a temperature not exceeding 8 C In case of storage conditions for specific products please refer to Schedule P The Drugs and Cosmetic Rules 1 9 4 5

The Indian Pharmacopoeia specifies the following storage conditions -

Wherever the condition for storage is not specified medicines may be stored under normal temperature In a country like India however where normal temperatures soar to h i gh temperatures it is recommended that medicines be stored in a cool place

Activity Prepare a list of the storage requirements mentioned on the label of about 20 products in your pharmacy and check if the temperature is maintained

47

25 Special Storage o f s u p p l i e s If the product has no special instructions normal storage conditions apply This means storage in dry clean w e l l -ventilated premises at temperatures of +15 C to +25 C or depending on the climate up to +30 C (WHO1990) Storage instructions are product specific Different brands of the same generic drug may have different storage requirements as they may have different packaging or formulations It is essential to follow the product manufacturers storage instructions to the maximum extent possible Less stable medicines must be stored in specific conditions to maintain their quality or potency

The following products require special storage facilities

middot Products that must be kept frozen (usually vaccines and sera) middot Products sensitive to h eat an d r e q uir in g r e f r ig e r a tio n ( +2 C to +8 C) middot Products that have reduced shelf life at uncontrolled room temperature and need

mechanical ventilation or air conditioning middot Flammable products that require separate fireproof premises middot Products prone to theft o r m i s u s e

Products needing storage in a controlled environment -

The usable shelf life of the following products may be reduced if stored at uncontrolled humidity or at room temperature in hot climates -

middot Some injectables (eg adrenaline) Most injectable preparations are less stable than solid oral forms (tablets and capsules) Injectable preparations in solution are particularly unstable Many injections must be protected from light as well as heat

middot Intravenous fluids (particularly if packed in p lastic containers) middot Some suppositories pessaries creams and ointments These products may melt at

temperatures greater than 30 C Once this happens it is not advisable to use them because the active ingredient in the formula may get unevenly distributed

middot Products containing rubber latex cellulose or some plastics Condoms most sterile disposable medical devices and surgical products such as syringes needles and catheters require protection from excessive humidity and strong light and heat Any o f these conditions may make products brittle stained amp unusable Sterility cannot be assumed if packaging is damaged

In hot climates these products should be stored in the coolest place possible preferably with air conditioning or air circulation fans

48

Products needing freezing or refrigeration-middot Vaccines blood products and many other medicines lose potency if kept even for a

brief period at temperatures outside the recommended range For these products the cold chain must be maintained at every stage of the distribution system

middot Freezing is as damaging as high temperatures for some products including injectable contraceptives ergometrine insulin adrenaline and the DPT DT TT and Hepatitis B vaccines Such products therefore sho uld not be allowed to freeze (not be kept in the freezer compartment)

middot Short periods at room temperature (during transportation or local distribution for instance) may be acceptable for many products (such as ergometrine a n d i n s u l i n ) e v e n t h o u g h s u c h e x posure can to some extent reduce shelf life Other items such as vaccines should always be transported in cold boxes

Storage of insulin injections-

middot Insulin should always be stored in a refrigerator at the recommended temperature of 2 -8 C

middot Insulin should not be kept in the freezer compartment of the refrigerator middot Insulin should ideally be stored horizontally middot It should not be exposed to sunlight or excessive heat middot Insulin suspensions should not be used if the suspension cannot be properly

resuspended due to cake or clump formationbull

Controlled drugs -Narcotics (for example Pethidine injection morphine preparations) and other specified drugs that may be abused are governed by special legislation and regulations The following security measures are suggested in the pharmacy -middot A safe or reinforced double locked cabinet fitted with a light (preferably with a red

bulb) that comes on when the door is opened

49

middot A special register recording details of each receipt or issue with 2 signatures physi cal counting of medicines after each entry and signatures at handover takeover

middot Independent audit (by supervisors and drug inspectors)

Products prone to theft abuse or misuse -

Some medicinesproducts are particularly prone to theft abuse or misuse These include expensive medicines (eg insulin) certain antibiotics and products prone to abuse or misuse like psychotropics etc

Such medicinesproducts should be stored adequately They require stricter record keeping and more frequent stock taki ng than others Periodic audits should be carried out to check for consumption against actual recorded use (registers prescription records stock records etc) to expose any theft or misuse bull26 Storage and stability of medicines Medicines are not stab le indefinitely They are stable for a specific period of time sometimes for a brief period Poor storage conditions accelerate the drug degradation (decomposition) Temperature light and moisture are the most important contributing factors for drug instability It is important to identify and be aware of the potential for instability There is a need to comply with storage requirements to ensure quality medicines for patients It is also important to offer advice to patients too about appropriate storage o f medicines at home The dispensing label should state the storage condition required and be backed up by a verbal reminder especially where special storage is required bull

50

In case stability and storage problems are seen with formulations they should be reported immediately to the representative of the manufacturer and taken out of circulation till the stability problems have been resolved

The pharmacist can easily detect stability problems when products show change in appearance color odor settling of the product contents breaking of emulsions melting of creams oozing of contents from the containers and any such physical changes

3 STOCK CONTROL AND EXPIRY MONITORING 3 1 S t o c k C o n t r o l For economic reasons pharmacists do not like to have stock on their shelves for long periods of time The aim should always be to keep stock at a level that will just meet demand Normally most manufactured medicines have a long shelf life Even then it is essential that there is efficient stock rot ation so that the older stock is used first It is also a good practice to check the expiry date as an integral part of the dispensing process When short shelf life products are involved stock levels may have to be modified to prevent medicines regularl y expiring on the shelves

32 Stock rotation and expiry monitoring In order to avoid accumulation of expired and obsolete stock medicines should be stored and issued according to the following guidelines -middot The stock control system must record the ex p i r y d a t e a n d t h e d a t e o f r e c e i p t middot Stock must be stored so that earliest expiring batches are picked and issued first middot The First In First Out (FIFO) system - In this system the stock which is received

first is sold first This system however may not be useful for pharmacies because most of the stocks carry an expiry date For pharmacies the FEFO system is more practical

51

middot The First Expiry First Out (FEFO) system - In this system the stock having an earlier expiry is sold first The stock with longer shelf life should be placed farthest to the back (or at the bottom in case o f sta c k e d b oxe s) T h is is pa r tic u la r ly impor ta n t with products that have short shelf lives such as vaccines some vitamins antibiotics etc and reduces losses due to expiry

middot E x p i r y dates should be noted on the stock record upon receipt Stock nearing expiry should not be accepted unless it can be used before expiry

Computerization and expiry monitoring In the pharmacy computerization facilitates both checking stocks and expiry mo nitoring and helps-bullbullKeeping a check on products nearing expiry bullbullKeeping a check on non- moving and slow moving products bullbullTo facilitate the removal of medicines nearing expiry from shelves in time to send them back to the wholesaler or supplier

Periodic checking for expiry The expiry date for medicinal products is a critical aspect in pharmaceutical dispensing and due importance should be given to it Periodic checking for expiry of medicines will ensure that the patient will never receive products that have crossed their expiry date During periodical checking of expiry the personnel involved should remove medicines that are nearing expiry bullbullIn -house threshold periods should be set and followed for retrieval of such medicines from the shelves bullbullSuch medicines should be stored separately These should either be dispensed immediately (thus ensuring that they are used before the expiry date) o r t h e y s h o u l d b e returned to the suppliers bullbullA separate area should be designated (cupboard or shelf)marked[FROZEN ZONE] which is adequately marked EXPIRED GOODS- NOT FOR SALE to store all expired stocks FROZEN ZONE

52

Remember Expired medicines are a NATIONAL WASTE So stock only what you can sell Avoid expiries save precious medicines for the nation

Treatment and disposing of expired medicines bullbullProcedures need to be in place for the treatment of expired medicines bullbullThe expired medicines need to be collected and be sent back to the supplier or company for appropriate disposal bullbullRecords must be maintained for expired medicines and how they are disposed off bullbullIn case of medicines that are not returnable to suppliers procedures for disposal need to be followed by the pharmacy in conjunction with the FDA The following procedure can be followed if medicines cannot be returned to suppliers ( T h e b a s i c p h i l o s o p h y of appropriate disposal is to prevent their re- circulation and use) bullbullC u t t h e c o n t ainer in such a manner that the label is also cut In case of tablets and c a p s u l e s d e s t r o y them by disposing them in a bucket of water bullbullUse landfill procedures (deep burial into the ground as per stipulations of Medical Waste Disposal Act prevalent in the respective state) bullbullPour the liquids into the sink and wash away with sufficient quantity of water bullbullKeep a record of such disposal with full details of medicines destroyed Although these measures are usually adopted care has to be taken with such tr e a t m e n t a s studies have shown that flushing of medicines has resulted in tracessmall quantities of medicines being found in waterways and groundwater having potential health and environmental effects

4 O T H E R A S P E C T S 41 Design of storage areas The following important factors need to be considered in design of storage areas -middot The retail outlets in hot areas in summers should be air-conditioned Similarly in

a r e a s o f e x t r e m e c o l d t h e p r e m i s e s w o u l d r e q u i r e w a r m i n g e s p e c i a l l y i n w i n t e r s t o maintain cool temperatures The placement of air -conditioners and heating devices should be such that medicines are not directly exposed to the cold or heat

middot Due consideration should be given to storage requirements of formulations while designing shelves and cupboards in retail outlets Sufficient shelf height should be provided so that all liquid products can be stored vertically As far as possible the shelves should be covered with glass panels to protect medicines from dust and p r e v e n t r a p i d f l u c t u a t i o n s i n temperature

middot Medicines should be stored according to the storage instructions on the labels bullIt is ideal to have a door at the pharmacy entrance to prevent dust from coming in as well as reduceprevent cooled air from going out This may not however be considered feasiblepracticable by many pharmacy owners for fear that clients may not enter the pharmacy because the door may act as a barrier An air curtain is a good alternative to a door

middot There should be minimal direct sunlight falling on the products Particular consideration should be given to premises directly facing the sun

middot bullThe arrangement of lighting in the interior of the premises should also be in a manner that the lights are not focused on the products It has been shown that light causes not only chemical damage but also can catalyze physical changes like moisture uptak e by the products Care should be taken to ensure that only diffused light falls on them

53

middot As far as possible provision should be made for a temperature and humidity indicator device in a pharmacy These devices are now easily available

middot Stability studies o f m e d i c i n e s p a c k e d i n b l i s t e r s h a v e r e v e a l e d t h a t i f t h e s e a r e exposed to light they tend to absorb moisture It is therefore necessary to store them in suitable cartons so that the blisters are not exposed to light Pharmacists should do this even if the manufacturer has not provided cartons

middot Light and temperature sensitive products should not be stored on counters where the light is intense or direct and there is no protection from temperature and humidity

42 Cleaning and maintenance i) Cleaning of storage areas

The storage areas of the pharmacy should be cleaned periodically and cleanliness should be maintained at all times The Standard Operating Procedure for cleaning should be designed and followed accordingly Schedules for cleanups should be laid down and adequate cleaning equipment should be made available

Tips for maintaining cleanliness middot Provide clean pieces of cloth for wiping at various locations in the pharmacy

Replace with clean cloth at regular intervals middot Keep separate pieces of cloth for floors shelves and medicines middot Use a disinfectant andor soap solution to clean floors middot Ensure removal of dust and prevent accumulation of dirt middot Ensure removal of cobwebs middot Use a vacuum cleaner for cleaning areas not easily reachable middot T a k e c a r e t h at breakages are handled and cleared effectively middot Observe the factors leading to waste generation in the pharmacy and take appropriate

measures to tackle the problem middot Record all cleaning procedures performed and maintain all the documents required

For ex a m p l e -bullbullThe floor of the pharmacy may be swept with a broom and swabbed with soap water every morning bullbullThe floor may be swabbed with a disinfectant every week bullbullThe entire premises including shelves and cupboards may be cleaned with a cloth (to remove dust and to check for medicines approaching expiry date or expired medicines) every three months bullbullAll the steps followed should be r e c o r d e d

The floor shelves drawers have to be cleaned and a check should be kept on dust cobwebs spillages due to breakage etc It is therefore essential to have SOPs for cleaning laying down cleaning frequencies allotting responsibilities and maintaining a daily record in the logbook to document all these activities

54

While cleaning dust settled on dosage forms like bottles tubes etc should be removed Before dispensing the products should also be wiped to remove any dust settled during storage

For refrigerators bullbullDefrosting and cleaning should be done at regular intervals bullbullSwitch off the refrigerator while cleaning bullbullCleaning should be done quickly and stocks put back immediately

i i ) Pest control Pests are a serious problem in India where insects reptiles and rodents (eg cockroaches l i z a r d s r a t s s i l v e r f i s h (Deemak - in Hindi ) etc) may find access to the pharmacy storage areas Insects like ants and borer ants may often attack wood in the pharmacy causing d am ag e to shelves cupboardsPest c ontr o l in a p h a r m a c y c a n b e a d i f f i c u l t t a s k b u t t o avoid possible contamination and physical damage to stock it is necessary to keep pests out of the pharmacy premisesPest control measures should be implemented with proper p r e c a u t i o n s t a k i n g u t m o s t c a r e t o a v o i d contamination of medicines

55

Th e following pest control measures c a n be ta ke n f r om tim e to tim e -bullbullRat bait and traps can be placed at various locations bullbullInsecticutors can be used on a permanent basis bullbullInsecticidal sprays and repellants can be used from time to time

i i i ) Fire precautions

Combustible trash such as cartons boxes and other packing waste must not be allowed to accumulate in the store Waste should be deposited in appropriate waste bins and be d i s p o s e d o f f o n a d a i l y b a s i s

F i re detection and fire fighting equipment must be maintained and regularly inspected The pharmacy personnel should receive adequate training in fire fighting techniques and emergency actionFire prevention measures should include a prominently displayed ldquoNoSmokingrdquo sign careful handling and disposal of combustible waste materials and checking of electrical connections at regular intervals

iv) Security middot Doors shutters of the pharmacy should be strong and be fitted with secure locks middot Counters should be designed so that unauthorized personnelclients do not have

access to areas where prescription medicines are stored Access to such areas should be restricted to the pharmacy staff

middot All the pharmacy staff handling supplies should be accountable for their ac t i o n s

56

middot bullSpecial care must be taken in case of Schedule X and manufactured drugs (under NDPS Act) Such medicines should be kept under lock and key and the key should be kept with the Chief Pharmacist or i n h i s a b s e n c e t h e s e n i o r p h a r m a c i s t

v) Breakagespillage and damaged product Products that have been damagedspoiled during storage and handling spillages and broken glassware should be disposed off according to procedures laid down by the pharmacy Broken and damaged products s h o u l d b e p l a c e d i n a segregated area to be returned to the supplier

vi) Inspection Senior staff should inspect all pharmacy areas regularly The shelves and drawers should b e c h e c k e d d a i l y f o r signs of pests and dust Ceiling and walls should be checked for dirt and cobwebs Stock should be checked on a regular basis for deterioration due to climatic conditions

43 Product recalls Products found to be defective should be quickly recalled (withdrawn from the market) The instructions are generally issued either by the manufacturer or the regulatory agency The level of recall is determined by both the degree of risk and the extent of distribution of the product and in India is mainly directed at the distribution chain

On receiving the details of the defective substandard spurious batchbatches of a medicine to be recalled from the manufacturer or the stockist or the FDA the pharmacy should immediately check if the particular b a t c h i s i n s t o c k a n d i f s o s u s p e n d i t s s a l e immediately

Similarly if the regulatory authority in the country bans a particular medicine or FDC the pharmacy should immediately check and remove all the different brands of that particular medicine under consideration

The details of medicines and their batches to be recalled should be available in the q u a r a n t i n e a r e a w h e r e stocks are received and checked This is to ensure that such medicines do not come into the pharmacy

middot The pharmacy should develop SOPs for recall of medicines middot The pharmacy staff should be immediately informed about such medicines and

the details should be displayed in writing in a prominent place in the pharmacy middot Rapid action helps avoid unnecessary exposure to such medicines once the

problem has been d e t e c t e d middot The progress of the recall procedure in the pharmacy should be monitored every

few days to ensure complete compliance middot All stocks of the recalled products should be stored separately from the saleable

stock These can be stored in the expiry cupboard segregated from the expired goods and be appropriately labeled ldquoRecal l e d G o o d s - Not for Salerdquo

The supplier should be notified and asked to replace defective products middot All the details of the procedures followed should be duly recorded in a Recall

Register maintained specially for the purpose The register should include d etails such as -middot Date of the recall middot Nam e of the product

57

bullbull

middot Details of the product (name of manufacturer batch number expiry date) middot Nu m b er of units purchased sold a n d sto c k in ha nd middot Reason for recall middot Nam e of the supplier to whom produc ts w e r e returned along with the date and quantity middot Name and signature of the designated personnel carrying out the recall procedure and recording details middot Name and signature of the chief pharmacist verifying the recall procedures and recording details 4 4 Returned medicines

Medicines may be returned to the pharmacy by clients due to the following reasons -bull

bullbull Unused medicines bullbull Course not completed bullbull Therapy changed by doctor bullbull Side effects experienced by patient bull

bullbull DamagedDefective medicines bullbull Missing or defaced label bullbull Missing tablets in a stripblister bullbull Leakage in bottles bullbull Leakage in strips bull

bullbull Expired medicines

Appropriate SOPs should be framed and followed for their acceptancerefusal and disposal middot bull For unused medicines returned by clients the p harmacy personnel should verify

that these were purchased from their pharmacy They should then be checked for integrity of the packing the dosage form and the expiry date and verified with the client whether they were stored in appropriate conditions This again is at the discretion of each pharmacy

middot The damageddefective medicines returned to the pharmacy should be taken back and stored separately Existing stock of the same product should be checked for similar defects

middot Expired medicines should be accepted from clients at the discretion of the pharmacist and be immediately shifted to the expired goods cupboard These can be stored segregated from the pharmacys own expired goods and be appropriately labelled ldquoExpired Goods returned by clients- Not For Salerdquo

It is advisable not to accept returned medicines requiring cold chain storage (refrigeration) because it cannot be ensured that the cold chain was maintained when the medicines were in the hands of the patientclient middot Appropriate adjustments in t he stocks should be made for medicines

returnedexchanged to update the inventory middot The medicines should then be returned to the respective shelves middot A lsquoReturned Goodsrsquo register needs to be maintained to record all details of returned

medicines

R egister should include such details as-

58

middot N a m e o f t h e p a t i e n t middot Nam e of the product and quantity r e tu r n e d middot Product details such as the batch number and expiry date middot Condition in which received middot Reason for returning products middot Compensatory measures taken wi t h r e s p e c t t o c l i e n t middot Action taken with respect to product middot Name and signature of the personnel accepting the returned medicines and recording details middot Name and signature of the chief pharmacist verifying the recorded details

What the pharmacist would have learnt from this module The storage of medicines is a critical factor in the distribution cycle bullbull Stocks received by the pharmacy should be quarantined in a separate area and necessary checks s h o u ld be performed to ascertain the qua lity a nd quantity of stocks received bullbull Whatever pattern and means of storage used the products should be stored so as to maintain their potency and integrity bullbull Storage conditions should be monitored and maintained on a regular basis bullbull Optimum stock levels should be maintained and regularly monitored for expiry bullbull The design of storage areas should facilitate appropriate storage of medicines bullbull Cleanliness should be maintained in the pharmacy bullbull Adequate measures should be taken in case of returned medicines and recalled products

Optimum storage of medicines is mandatory whether at the distribution stage at the pharmacy or ultimately within the homes of patients The pharmacist has an important r o l e t o p l a y i n t h e s t o r a g e o f m e d i c i n e s i n m a i n t a i n i n g d r u g p o t ency and efficacy and thus facilitating optimum therapeutic benefits Good Pharmacy Practice - IPA -CDSCO - WHO Appendix I Quality Assurance Templates of letters for use if found not of Standard Quality [Frozen and expired goods ]

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated To Name of the Supplier with address

Sub Not of Standard Quality GoMP-Supply of Drugs and medicines-(Codename) Return of Stocks to the Suppliers-reg(New drug policy 2009) Previous letterinvoice ref Sl No Drug Code Drug name

Manufacturing date Expiry date

Supplier address

B a t c h n o

The above items of PO nodated was drawn by the Drug Inspector (Place) on (______________date) as a statutory sampling and declared ldquoNot of Standard

59

Qualityrdquo on -(______________date) by the Government Analyst for the following reasons

- ldquoThe product sample do not confirm to IP specification for (Drug codename with respect to the content of drugrdquo

- ldquoThe product has already been blacklisted by TNMSC on -(______________date) for the failure of (quantity) of batches of drug codenamerdquo

As per the clause of the te nde r d oc um e nt ldquo I f the sa mple s d o not c onf o r m to statutory standardsthe tenderer will be liable for relevant action under the existing laws and the entire stock in such batch should be taken back by the tenderer within a period of 30 days o f t h e r e c e i p t o f t h e l e t t e r f r o m t h e v e n u e

The stock shall be taken back at the expenses of the tendererthe Procurement Authority have the right to destroy such Not of Standard Quality if the tenderer does not take back the goods within the stipulated time

The Procuring Authority will arrange to destroy the Not of Standard Quality drugs within 90 days after the expiry of 30 days mentioned above without further notice and shall also collect demurrage charges calculated at the rate of 2 per week on the value of the drugs rejected till such destructionrdquo

Hence we regret to inform you that you will have to take back the stocks available of the abovesaid batch at your own cost from the drug stores where you have supplied the above batch

Kindly acknowledge the receipt of this reference at once

P r o c u r e m e n t A u t h o r i t y Seal and Stamp

Copy to Ref No dated

1 ) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated13082010

To

Sub Frozen Drugs-ordered to return to the Suppliers-reg(New drug policy 2009) Previous letterinvoice ref

The following products which were earlier frozen have now been ordered to return to suppliers directly with permission from the State drug Authority In this regard the suppliers have been instructed to take back their failed batch from the drug store of the stores Hence you are now instructed to return the following failed batches to the suppliers by obtaining proper authorization letter and acknowledgements from them

60

Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

Kindly acknowledge the receipt of this reference at once

Procurement Authority Seal and Stamp

Copy to

Ref No dated 2) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated14092010

To

Sub Frozen Drugs-ordered to return to the Suppliers- for issue of gate pass after verification reg(New drug policy 2009) Previous letterinvoice ref

The following products which were earlier frozen have now been released Hence they may be issued Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

Kindly acknowledge the receipt of this reference at once

Procurement Authority Seal and Stamp

Copy to

61

Ref No dated 3) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated

To

Sub Stop instruction-reg(New drug policy 2009) Previous letterinvoice ref

Until further instructions stop issue all the batches of the following item Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

You must intimate the available stock in the stores of the said batch Number to the Procurement Authority immediately Also retrieve quantity if already issued

Procurement Authority Seal and Stamp

Copy to

Ref No dated 4) HOD Procurement Office of

62

Appendix II Material handling in drug stores

Rack approx rates and dimensions

S No

Item Description UOM Approx Rate

1 MEDIUM DUTY RACK SIZE 2900 H X 3090 W X 800 D IN MM (AS PER SPECIFICATION)

Each 2499800

2 MEDIUM DUTY RACK ADD ON UNIT FOR SIZE OF SR NO2

Each 2243100

To locate a Box no 3 Rack no 14 in row3

SAMPLE OF RACK no Bin numbering -------------- S a y R K 1 4 R o w 3 B o x 1 6

SAMPLE LAYOUT of RACKS in a Drug Stores

63

Sample of another warehouse of distribution warehouse system

64

65

Slotted Angle racks with bin cards

66

Plastic Pallets

Plastic pallets ar e l i g h t w e i g h t l o w- c ost and exceed industry standards for strength and durability

NOTE A pallet has bottom deckboards (see sketch) A skid does not have bottom

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deckboards

Battery Operated Stacker

Electric Stacker Ehh (Manual Push Type) - Manual drive - Lifting electrically with Battery 12 V 88 Ah - For loading and un-loading of trucks - Battery and loading device built - in - Battery charge gauge and charging current gauge Simple and Easy Operation - Lifting and Lowering electrically direct on steering arm - Pulling and pushing through steering arm - Electrically operated relief valve on hydraulic aggregate Safe Operation - Emergency Off Switch - Constant lowering speed - Protection through lowering brake valve - Overload protection through overload brake valve - Load chains covered preventing pinching threat - Electrically interlocking during loading process - Secured battery compartment opens upwardly - Stable buffering of the steering arm in upright position - In accordance with EWG Guidelines 89 240 - In accordance with VBG 12b Prevention of Accidents

Pallet Truck [ Top ]

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----------------------------------------------------------------------------------------------------------------------------

For Transport Of All Goods On Pallets Safe and Easy Operation - through single hand operation Lifting moving

lowering with steering handle - neutral position of the hydraulic possible - overload pressure relief valve Long Service Life - robust co n s t r u c t i o n

- special hardened axles - hardened chromium plated ram - maintenance free Easy Maneuverability - through rubber steering rollers - nylon fork rollers

A h a n d t r o l l e y

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Trolley with plastic bins for several items del ivery

70

Digital Weighing balances

Balances amp Scales EF Seriers Precision Electronic Balance

71

1

Ice lined Refrigerators

600 litres refrigrator

72

Walk in cooler

vacuum cleaner

73

STORAGE AND STOCK MANAGEMENT The expiry periods of pharmaceutical products have meaning only if the products are stored under proper conditions otherwise products are likely to lose their potency before the actual date of expiry

A pharmacist is a vital link in the distribution chain for pharmaceutical products The medicinal products remain for a long period during the distribution cycle at the wholesaler and at retail pharmacies It is therefore very important to maintain proper storage conditions in these units

Every community pharmacy however large or s mall needs to store and manage its medicine stocks effectively There must be systems to ensure

middot bullbull Secure storage middot bullbull Clean and correct environmental conditions during storage middot bullbull Accurate and effective record keeping middot bullbull Effective stock rotation and expiry monitoring middot bullbull Effective fire and theft prevention middot bullbull Effective rodent pest control

For easier un derstanding this module has been divided into the following sections

1 Quarantine and checking of stocks 11 Quarantine area 12 Checks to be carried out on new stocks

2 S t o r a g e 21 Need for proper storage 22 Different patterns of storage 23 Different means of storage 24 Temperatureclimatic conditions 25 Special storage of supplies 26 Storage and stability of medicines

3 Stock Control and Expiry Monitoring 31 Stock control 3 2 S t o c k r o t a t i o n a n d e x p i r y m o n i t o r i n g

4 Other aspects of s t o r a g e 41 Design of a storage area 42 Cleaning and maintenance 43 Product recalls 44 Returned goods

33

1 QUARANTINE AND CHECKING OF STOCKS

11 Quarantine Area D r u g S t o r e pharmacies receive stoc k s f r o m su pplie r s a c c or d ing to pur c h a se o r d e r s T he stock that is received must be visually checked for quality and quantity The stocks must be kept in a separate area until the checking is done to avoid intermixing with existing stock This necessitates the presence of a separate area within the pharmacy w h e r e i n t h e storage and other checking of stocks can be performed This area is called the QUARANTINE AREA This area should be marked and identified adequately to distinguish it from other areas

The area may be marked using different means 1 ) A s m a l l board saying Quarantine on a separate table used exclusively if it is in the middle 2) A board on the wall if the table on which the quarantine stock is placed is against the wall

middot Stock received from wholesalers should be immediately transferred t o t h e Quarantine Area

middot In the Quarantine area the stock may be stored on racks shelves or in cupboards to prevent ingress of moisture dirt and other contaminants

middot Regular stocks from the pharmacy should not be left kept in the quarantine area Special care has to be taken in case of refrigerated medicines supplied by the suppliers so tha t the y do not remain in the quarantine area for long periods of time They should be immediately checked on receipt and transferred to areas for refrigerated storage s o a s to maintain the cold chain bull

Advantages of having a separate Quarantine Area middot Avoids cross mixing of newly arrived stock from existing stock till it is checked middot Lays stress on checking the quality of the stock received middot S to ck checking ensures t hat defective andor expired goods do not enter the storage areas

34

bullbull

bullbull

12 Checks to be carried out on new stock

Unpacking and checking stock

Supplies received should be unpacked and checked in the quarantine area Staff doing the checks should be adequatel y trained in what they have to check when stock arrives

Checking should be seen not simply as counting the units received but as a part of the quality assurance system bullThis should include middot Visually inspecting the packaging middot Checking the integrity of containers middot V erifying the completeness and leg ibility of la b e ls ( a ppr o ve d dr u g name strength any special storage instructions and expiry date)

bull

The expiry dat e should be checked to ensure that there is adequate shelf life remaining

Supplies should be individually checked using a checklist 35

Checklists

36

The wholesaler supplying the product should be notified immediately in case of any discrepancies ( and the details should be recorded in a register) and sent in a written format to the supplier It should include middot Missing boxes or cartons middot O p en tampered boxes or cartons middot Missing supplies middot Differences in the actual quantity and the quantity shown on the packing middot Additional medicines that had not been ordered but have been supplied middot D a m a g e d b r o k e n o r p oor quality medicines middot Any other discrepancies

The purchase invoices are an important aspect to be considered The invoiced documents should be signed and filed for reference as per the Drugs and Cosmetics Act and retained for at least 3years

If the wholesaler supplies medicines as an emergency without a bill or against a delivery challan

middot The supplies should be checked for integrity and inspected for damage middot The details of supplies received should be recorded middot The supplier should be asked t o send the bill as early as possible middot When the bill is received it should be checked against the details recorded and anomalies if any should be reported to the supplier

To keep a track of the received stock maintaining a S t o c k R e c o r d C a r d c a n b e very useful The entries in the stock record card can be made while checking the stock received STOCK BIN in the stores should have Stock record card

Maintaining a stock card for every product may not be very practical for a retail pharmacy however it could be maintained for costly medicines Nowadays it is much more practical and easier to maintain records using computers

The pharmacist should ensure that medicines manufacturedmarketed by a company are received only through an authorized distribution network of that company This is important to prevent spurious and counterfeit drugs from entering the pharmacy

37

2 STORAGE 21 The need for proper storage The storage of medicines and other products is an important requirement of Good Pharmacy Pr actice Appropriate storage of medicines is essential -

middot bullTo ensure that the potency is maintained middot bullTo prevent deteriorationspoilagedegradation middot bullTo ensuremaintain physical integrity

To ascertain that the quality and safety is maintained throughout their shelf life Storage requirements need to be considered on 2 aspects

a) Integrity of medicines Medicines should be stored in such a way so as to maintain their integrity and potency middot Maintain the right temperature required middot Protect from excessive humidity middot Keep medicines away from direct sunlight middot Protect from pests and rodents

b) Physical location middot Should be easy to locate middot Accessible middot Orderlysystematically placed

2 2 D i f f e r e n t p a t t e r n s o f s t o r a g e The pharmacist could follow any of the different patterns of storage The pattern of stora ge should be selected in such a way that it facilitates speedy and efficient dispensing of medicines

The pattern of storage could vary with each pharmacy experience usual practiceroutine of staff and the person-in charge and also depending on space av ailable turnover etc (i) The medicines could be stored c o m p a n y w i s e ie the medicines manufactured by one company should be grouped together and kept in one place Within each company shelfshelves the medicines may be placed in alphabetical order for easy and quick placement and removal Also bottles tubes boxes etc may be segregated within that shelf

38

(ii) The medicines may also be stored in a lphabe t ic al o r de r ie they are placed in order from left to right based on their name The first letter of the name is used to g r o u p t h e m e d i c i n e s t o g e t h e r a n d k e e p t h e m i n o n e l o c a t i o n I n s o m e p h a r m a c i e s a l l t h e strip packing are placed in drawers or boxes in alphabetical order each box or drawer containing strips of one particular alphabet This system ensures that the strips always remain e n c l o s e d i n t h e b o x e s d r a w e r s a n d a r e n o t e x p o s e d t o d u s t T h e d i s a d v a n t a g e i s that it might lead to mix -u p o f strips in the same drawer and it may cause a problem incase of similar looking strips in which case a wrong medicine may be dispensed Secondly cut strips lying around in the drawer may lose their identity if the batch n u m b e r andor expiry date is not seen on the cut portion of the strip

39

(iii) The medicines may be stored according to their therapeutic class ( e g a n t i b i o t i c s anti asthmatics or anti hypertensives) ie the medicines are kept together based on their pharmacological or therapeutic action

(iv) The medicines may be stockedsegregated according to dosage forms eg l i q u i d s (bottles) solid oral dosage forms eye drops rotacaps ointments etc all stored on separate shelves

Always Remember I Storage of prescription medicines should preferably be separate from OTC medicines OTC medicines especially those that a r e a d v e r t i s e d m a y b e d i s p l a y e d f o r c l i e n t s t o select or to ask questions about [OTC-O v e r t h e c o u n t e r ] II Storage according to temperatures is a must no matter which pattern of storage is followed Also within a particular storage area segregated storage may be maintained In a refrigerator for example medicines may be stored in trays racks and the freezer according to the temperature required

40

Whatever pattern of storage is selected all the personnel should ensure that middot The stocks are stored in an orderly manner middot The medicines are kept back in the same place from where they were removed middot All medicines are arranged neatly once in a while

middot The personnel should be careful while storing the medicines middot They should not throw the medicines haphazardly 23 Different means of storage

middot Within each temperature and security zone medicines must be stored so that they are easily accessible and protected against damage

middot Basic means of storage include shelves racks and drawers middot To prevent dust from entering the shelvesracks it is ideal to have glass

shutterssliding glass doors This can however be disadvantageous because accessibilityspeed is hampered in removing a product from the shelf because the glassshuttersliding glass has to be

41

opened m o v e d e v e r y t i m e a p r o d u c t h a s t o b e p i c k e d u p U s e o f a i r c o n d i t i o n e r s f o r t h e p h arm acy with a closed door at the e n t r a n c e o r a n a i r c u r t a i n c a n r e d u c e t h e d u s t problem In such cases the shelvesracks may be left o p e n

bull

middot Direct storage of cartons on the floor should be avoided because besides being an unhealthy practice the contents may also be damaged by moisture bull

middot Store medicines preferably in shelves with glass shutters for visibility middot Closed shelves further prevent dust from going in especially in India where most

pharmacies are located along busy roads middot Some medicines have to be refrigerated or stored in a cool or cold place Having a

refrigerator or two (as per the need of the pharmacy) is essential to store suc h medicines at temperatures mentioned on the label bull

42

Refrigeration middot All cold chain equipment should meet required standards middot Improvement in refrigeration technology has provided frost -free refrigerators

Pharmacists should opt for frost-free refrigerators as they are easy to maintain and protect printed packaging materials Conventional refrigerators may cause water falling from trays below the freezer on medicines stored in the refrigerator thus causing soggy labels

middot bull Frost-free refrigerators also provide separate and large compartments for the freezer portion (required for storing medicines needing sub-z e r o t e m p e r a t u r e ) and the main storage area with separate doors so that opening one door does not disturb the storage temperature in the other compartment

Care should be taken to keep the refrigerator on 24 hours a day It should not be switched off after working hours It is advisable to have an inverter connected to the refrigerator so that the refrigerator re mains working even when there is a power outage

middot The refrigerator door should be closed tightly middot The refrigerator door should not be left open for too long middot Space should be left between medicines stored in a refrigerator to allow air to

circulate middot The ref rigerator should be placed about an arms length away from the wall

This will increase air circulation thus not affecting the cooling within the refrigerator

middot Vaccines should not be stored on refrigerator door shelves as they are exposed to warmer temperatures each time the door is opened Vaccines should always be stored on the middle shelves of the refrigerator

middot Refrigerated medicines should not be left out of the refrigerator for more than a few minutes

43

middot Consumable products like juices energy drinks e t c s h o u l d n o t b e s t o r e d a l o n g with medicines in refrigerators If required they may be kept in a separate refrigerator

middot An adequate number of refrigerators should be planned to store the entire stocks requiring refrigerated storage

middot Adequate procedures should be followed for defrosting cleaning and maintenance of refrigerators

middot Icefreeze packs should be kept in the freezer compartment so that they can be used for transporting cold temperature medicines The packs can be given to clients along with the medicines requiring cold temperature storage so that the temperature is maintained till the client reaches home and can then put the medicines in a refrigerator) Freezer packs can also be used to keep medicines temporarily in case there is a power outage or refrigerator breakdown

Activity

Prepare a SOP (Standard operating procedure chart) for cleaning a refrigerator Discuss it with your staff finalize its maintenance once a month through AMC -A n n u a l Maintenance contract CMC - Comprehensive maintenance contract and put it up on the pharmacy refrigerator Put the Purchase Order details name of manufacturer Phone of Service Engineer and a register to login the Machine service and down timeService reports may be maintained properly

Refrigerator monitoring and maintenance

middot bullIt is important to carry out routine monitoring and maintenance of the refrigerators and to organize an effective repair system

middot bullThe temperature in the refrigerator must be monitored and recorded routinely at least once a day

middot Any breakdown must be reco rded including the period during which the medicines were exposed to uncontrolled temperatures Medicines may then be kept or discarded depending on the problem guidelines or the manufacturers advice

middot Cold chain monitor cards and devices in or on packages that change color or otherwise alert staff to potential damage assist in monitoring (These are likely to be introduced in India soon)

middot It is essential to have a contingency plan in place before a refrigerator breaks down An arrangement can be made to move the contents to a private refrigerator elsewhere in the community or to obtain a regular supply of ice packs until the defect is rectified

Put filled water bottles in the bottom half of the refrigerator door in order to provide cooling in the refri g e r a t o r w h e n t h e r e i s a p o w e r o u t a g e T h i s m i g h t t a k e c a r e o f t h e temperature when there is no current for a couple of hours If the power outage is expected to last for several hours special arrangements such as an inverter UPS have to be made to keep the refrigerator constantly running in the absence of electricity middot Defrost the refrigerator in case of excessive ice formation and preferably at regular

intervals Keep a record of the same

44

2 4 T e m p e r a t u r e c l i m a t i c c o n d i t i o n s

i) Temperature control middot The medicines in a pharmacy need to be stored at appropriate temperatures to

maintain their stability middot An air-conditioned environment where temperature can be controlled is

recommended for pharmacies Air conditioning offers the option of setting the t e m p e rature as per requirements

middot bullIt is ideal to have an air conditioner to maintain the temperature below 25 C as most medicines require storage below this temperature Secondly this temperature is pleasing to both the staff and the visiting customers too

middot In the absence of an air conditioner circulating fans may be used middot This need is felt even more in certain parts of India where temperatures soar above 45

C and some areas where it falls to sub zero temperatures In such cases temperature maintenance is essential to prevent deterioration of medicines due to unnecessary exposure to drastic temperature fluctuations

middot This need is felt even more in certain parts of India where temperatures soar above 45 C and some areas where it falls to sub zero temperat u r e s I n s u c h c a s e s temperature maintenance is essential to prevent deterioration of medicines due to unnecessary exposure to drastic temperature fluctuations

i i ) Humidity or moisture control Moisture or humidity can adversely affect the stability of me dicines such as tablets capsules powders

45

Gelatin capsules become soft and swell on absorption of moisture The drug content of tablets may undergo surface hydrolysis The presence of moisture may encourage the growth of microbes It is therefore essential to control humidity

To reduce the effect of humidity the following suggestions may be followed -middot Open the windows to allow air circulation Use a fan to circulate fresh (outside) air middot In humid climate a dehumidifier is useful for preventing mo i s t u r e d a m a g e ( i n t h e absence of an air conditioner) middot For bulk containers of tabletscapsules do not keep the container open for a long time and replace the lid or closure immediately after taking out the required number of medicines for dispensing middot Do not allow the medicines to touch the floor or the walls The walls may be damp and may cause moisture absorption damaging the product

middot Calibrated thermometers and manometers can be used to detect temperature and humidity in the pharmacy

middot Periodici t y of checking the temperature should be fixed middot The climatic conditions should be recorded and documented middot Temperature charts should be available for ready reference

Documentation is one of the core activities for achieving and maintaining quality It is one of the most essential components of validation Temperatures in various areas

46

including refrigerators should be recorded at a predetermined periodicity usually daily at the hottest time of the day and such documents should be preserved i i i ) Storage conditions A number of storage conditions are mentioned on the labels of medicinal products These conditions have to be properly interpreted and appropriately complied with

According to the Drugs and Cosmetics Rules 1945

1 The term cool place means a place having a temperature between 10 C and 25 C

2 The term cold place means a place having a temperature not exceeding 8 C In case of storage conditions for specific products please refer to Schedule P The Drugs and Cosmetic Rules 1 9 4 5

The Indian Pharmacopoeia specifies the following storage conditions -

Wherever the condition for storage is not specified medicines may be stored under normal temperature In a country like India however where normal temperatures soar to h i gh temperatures it is recommended that medicines be stored in a cool place

Activity Prepare a list of the storage requirements mentioned on the label of about 20 products in your pharmacy and check if the temperature is maintained

47

25 Special Storage o f s u p p l i e s If the product has no special instructions normal storage conditions apply This means storage in dry clean w e l l -ventilated premises at temperatures of +15 C to +25 C or depending on the climate up to +30 C (WHO1990) Storage instructions are product specific Different brands of the same generic drug may have different storage requirements as they may have different packaging or formulations It is essential to follow the product manufacturers storage instructions to the maximum extent possible Less stable medicines must be stored in specific conditions to maintain their quality or potency

The following products require special storage facilities

middot Products that must be kept frozen (usually vaccines and sera) middot Products sensitive to h eat an d r e q uir in g r e f r ig e r a tio n ( +2 C to +8 C) middot Products that have reduced shelf life at uncontrolled room temperature and need

mechanical ventilation or air conditioning middot Flammable products that require separate fireproof premises middot Products prone to theft o r m i s u s e

Products needing storage in a controlled environment -

The usable shelf life of the following products may be reduced if stored at uncontrolled humidity or at room temperature in hot climates -

middot Some injectables (eg adrenaline) Most injectable preparations are less stable than solid oral forms (tablets and capsules) Injectable preparations in solution are particularly unstable Many injections must be protected from light as well as heat

middot Intravenous fluids (particularly if packed in p lastic containers) middot Some suppositories pessaries creams and ointments These products may melt at

temperatures greater than 30 C Once this happens it is not advisable to use them because the active ingredient in the formula may get unevenly distributed

middot Products containing rubber latex cellulose or some plastics Condoms most sterile disposable medical devices and surgical products such as syringes needles and catheters require protection from excessive humidity and strong light and heat Any o f these conditions may make products brittle stained amp unusable Sterility cannot be assumed if packaging is damaged

In hot climates these products should be stored in the coolest place possible preferably with air conditioning or air circulation fans

48

Products needing freezing or refrigeration-middot Vaccines blood products and many other medicines lose potency if kept even for a

brief period at temperatures outside the recommended range For these products the cold chain must be maintained at every stage of the distribution system

middot Freezing is as damaging as high temperatures for some products including injectable contraceptives ergometrine insulin adrenaline and the DPT DT TT and Hepatitis B vaccines Such products therefore sho uld not be allowed to freeze (not be kept in the freezer compartment)

middot Short periods at room temperature (during transportation or local distribution for instance) may be acceptable for many products (such as ergometrine a n d i n s u l i n ) e v e n t h o u g h s u c h e x posure can to some extent reduce shelf life Other items such as vaccines should always be transported in cold boxes

Storage of insulin injections-

middot Insulin should always be stored in a refrigerator at the recommended temperature of 2 -8 C

middot Insulin should not be kept in the freezer compartment of the refrigerator middot Insulin should ideally be stored horizontally middot It should not be exposed to sunlight or excessive heat middot Insulin suspensions should not be used if the suspension cannot be properly

resuspended due to cake or clump formationbull

Controlled drugs -Narcotics (for example Pethidine injection morphine preparations) and other specified drugs that may be abused are governed by special legislation and regulations The following security measures are suggested in the pharmacy -middot A safe or reinforced double locked cabinet fitted with a light (preferably with a red

bulb) that comes on when the door is opened

49

middot A special register recording details of each receipt or issue with 2 signatures physi cal counting of medicines after each entry and signatures at handover takeover

middot Independent audit (by supervisors and drug inspectors)

Products prone to theft abuse or misuse -

Some medicinesproducts are particularly prone to theft abuse or misuse These include expensive medicines (eg insulin) certain antibiotics and products prone to abuse or misuse like psychotropics etc

Such medicinesproducts should be stored adequately They require stricter record keeping and more frequent stock taki ng than others Periodic audits should be carried out to check for consumption against actual recorded use (registers prescription records stock records etc) to expose any theft or misuse bull26 Storage and stability of medicines Medicines are not stab le indefinitely They are stable for a specific period of time sometimes for a brief period Poor storage conditions accelerate the drug degradation (decomposition) Temperature light and moisture are the most important contributing factors for drug instability It is important to identify and be aware of the potential for instability There is a need to comply with storage requirements to ensure quality medicines for patients It is also important to offer advice to patients too about appropriate storage o f medicines at home The dispensing label should state the storage condition required and be backed up by a verbal reminder especially where special storage is required bull

50

In case stability and storage problems are seen with formulations they should be reported immediately to the representative of the manufacturer and taken out of circulation till the stability problems have been resolved

The pharmacist can easily detect stability problems when products show change in appearance color odor settling of the product contents breaking of emulsions melting of creams oozing of contents from the containers and any such physical changes

3 STOCK CONTROL AND EXPIRY MONITORING 3 1 S t o c k C o n t r o l For economic reasons pharmacists do not like to have stock on their shelves for long periods of time The aim should always be to keep stock at a level that will just meet demand Normally most manufactured medicines have a long shelf life Even then it is essential that there is efficient stock rot ation so that the older stock is used first It is also a good practice to check the expiry date as an integral part of the dispensing process When short shelf life products are involved stock levels may have to be modified to prevent medicines regularl y expiring on the shelves

32 Stock rotation and expiry monitoring In order to avoid accumulation of expired and obsolete stock medicines should be stored and issued according to the following guidelines -middot The stock control system must record the ex p i r y d a t e a n d t h e d a t e o f r e c e i p t middot Stock must be stored so that earliest expiring batches are picked and issued first middot The First In First Out (FIFO) system - In this system the stock which is received

first is sold first This system however may not be useful for pharmacies because most of the stocks carry an expiry date For pharmacies the FEFO system is more practical

51

middot The First Expiry First Out (FEFO) system - In this system the stock having an earlier expiry is sold first The stock with longer shelf life should be placed farthest to the back (or at the bottom in case o f sta c k e d b oxe s) T h is is pa r tic u la r ly impor ta n t with products that have short shelf lives such as vaccines some vitamins antibiotics etc and reduces losses due to expiry

middot E x p i r y dates should be noted on the stock record upon receipt Stock nearing expiry should not be accepted unless it can be used before expiry

Computerization and expiry monitoring In the pharmacy computerization facilitates both checking stocks and expiry mo nitoring and helps-bullbullKeeping a check on products nearing expiry bullbullKeeping a check on non- moving and slow moving products bullbullTo facilitate the removal of medicines nearing expiry from shelves in time to send them back to the wholesaler or supplier

Periodic checking for expiry The expiry date for medicinal products is a critical aspect in pharmaceutical dispensing and due importance should be given to it Periodic checking for expiry of medicines will ensure that the patient will never receive products that have crossed their expiry date During periodical checking of expiry the personnel involved should remove medicines that are nearing expiry bullbullIn -house threshold periods should be set and followed for retrieval of such medicines from the shelves bullbullSuch medicines should be stored separately These should either be dispensed immediately (thus ensuring that they are used before the expiry date) o r t h e y s h o u l d b e returned to the suppliers bullbullA separate area should be designated (cupboard or shelf)marked[FROZEN ZONE] which is adequately marked EXPIRED GOODS- NOT FOR SALE to store all expired stocks FROZEN ZONE

52

Remember Expired medicines are a NATIONAL WASTE So stock only what you can sell Avoid expiries save precious medicines for the nation

Treatment and disposing of expired medicines bullbullProcedures need to be in place for the treatment of expired medicines bullbullThe expired medicines need to be collected and be sent back to the supplier or company for appropriate disposal bullbullRecords must be maintained for expired medicines and how they are disposed off bullbullIn case of medicines that are not returnable to suppliers procedures for disposal need to be followed by the pharmacy in conjunction with the FDA The following procedure can be followed if medicines cannot be returned to suppliers ( T h e b a s i c p h i l o s o p h y of appropriate disposal is to prevent their re- circulation and use) bullbullC u t t h e c o n t ainer in such a manner that the label is also cut In case of tablets and c a p s u l e s d e s t r o y them by disposing them in a bucket of water bullbullUse landfill procedures (deep burial into the ground as per stipulations of Medical Waste Disposal Act prevalent in the respective state) bullbullPour the liquids into the sink and wash away with sufficient quantity of water bullbullKeep a record of such disposal with full details of medicines destroyed Although these measures are usually adopted care has to be taken with such tr e a t m e n t a s studies have shown that flushing of medicines has resulted in tracessmall quantities of medicines being found in waterways and groundwater having potential health and environmental effects

4 O T H E R A S P E C T S 41 Design of storage areas The following important factors need to be considered in design of storage areas -middot The retail outlets in hot areas in summers should be air-conditioned Similarly in

a r e a s o f e x t r e m e c o l d t h e p r e m i s e s w o u l d r e q u i r e w a r m i n g e s p e c i a l l y i n w i n t e r s t o maintain cool temperatures The placement of air -conditioners and heating devices should be such that medicines are not directly exposed to the cold or heat

middot Due consideration should be given to storage requirements of formulations while designing shelves and cupboards in retail outlets Sufficient shelf height should be provided so that all liquid products can be stored vertically As far as possible the shelves should be covered with glass panels to protect medicines from dust and p r e v e n t r a p i d f l u c t u a t i o n s i n temperature

middot Medicines should be stored according to the storage instructions on the labels bullIt is ideal to have a door at the pharmacy entrance to prevent dust from coming in as well as reduceprevent cooled air from going out This may not however be considered feasiblepracticable by many pharmacy owners for fear that clients may not enter the pharmacy because the door may act as a barrier An air curtain is a good alternative to a door

middot There should be minimal direct sunlight falling on the products Particular consideration should be given to premises directly facing the sun

middot bullThe arrangement of lighting in the interior of the premises should also be in a manner that the lights are not focused on the products It has been shown that light causes not only chemical damage but also can catalyze physical changes like moisture uptak e by the products Care should be taken to ensure that only diffused light falls on them

53

middot As far as possible provision should be made for a temperature and humidity indicator device in a pharmacy These devices are now easily available

middot Stability studies o f m e d i c i n e s p a c k e d i n b l i s t e r s h a v e r e v e a l e d t h a t i f t h e s e a r e exposed to light they tend to absorb moisture It is therefore necessary to store them in suitable cartons so that the blisters are not exposed to light Pharmacists should do this even if the manufacturer has not provided cartons

middot Light and temperature sensitive products should not be stored on counters where the light is intense or direct and there is no protection from temperature and humidity

42 Cleaning and maintenance i) Cleaning of storage areas

The storage areas of the pharmacy should be cleaned periodically and cleanliness should be maintained at all times The Standard Operating Procedure for cleaning should be designed and followed accordingly Schedules for cleanups should be laid down and adequate cleaning equipment should be made available

Tips for maintaining cleanliness middot Provide clean pieces of cloth for wiping at various locations in the pharmacy

Replace with clean cloth at regular intervals middot Keep separate pieces of cloth for floors shelves and medicines middot Use a disinfectant andor soap solution to clean floors middot Ensure removal of dust and prevent accumulation of dirt middot Ensure removal of cobwebs middot Use a vacuum cleaner for cleaning areas not easily reachable middot T a k e c a r e t h at breakages are handled and cleared effectively middot Observe the factors leading to waste generation in the pharmacy and take appropriate

measures to tackle the problem middot Record all cleaning procedures performed and maintain all the documents required

For ex a m p l e -bullbullThe floor of the pharmacy may be swept with a broom and swabbed with soap water every morning bullbullThe floor may be swabbed with a disinfectant every week bullbullThe entire premises including shelves and cupboards may be cleaned with a cloth (to remove dust and to check for medicines approaching expiry date or expired medicines) every three months bullbullAll the steps followed should be r e c o r d e d

The floor shelves drawers have to be cleaned and a check should be kept on dust cobwebs spillages due to breakage etc It is therefore essential to have SOPs for cleaning laying down cleaning frequencies allotting responsibilities and maintaining a daily record in the logbook to document all these activities

54

While cleaning dust settled on dosage forms like bottles tubes etc should be removed Before dispensing the products should also be wiped to remove any dust settled during storage

For refrigerators bullbullDefrosting and cleaning should be done at regular intervals bullbullSwitch off the refrigerator while cleaning bullbullCleaning should be done quickly and stocks put back immediately

i i ) Pest control Pests are a serious problem in India where insects reptiles and rodents (eg cockroaches l i z a r d s r a t s s i l v e r f i s h (Deemak - in Hindi ) etc) may find access to the pharmacy storage areas Insects like ants and borer ants may often attack wood in the pharmacy causing d am ag e to shelves cupboardsPest c ontr o l in a p h a r m a c y c a n b e a d i f f i c u l t t a s k b u t t o avoid possible contamination and physical damage to stock it is necessary to keep pests out of the pharmacy premisesPest control measures should be implemented with proper p r e c a u t i o n s t a k i n g u t m o s t c a r e t o a v o i d contamination of medicines

55

Th e following pest control measures c a n be ta ke n f r om tim e to tim e -bullbullRat bait and traps can be placed at various locations bullbullInsecticutors can be used on a permanent basis bullbullInsecticidal sprays and repellants can be used from time to time

i i i ) Fire precautions

Combustible trash such as cartons boxes and other packing waste must not be allowed to accumulate in the store Waste should be deposited in appropriate waste bins and be d i s p o s e d o f f o n a d a i l y b a s i s

F i re detection and fire fighting equipment must be maintained and regularly inspected The pharmacy personnel should receive adequate training in fire fighting techniques and emergency actionFire prevention measures should include a prominently displayed ldquoNoSmokingrdquo sign careful handling and disposal of combustible waste materials and checking of electrical connections at regular intervals

iv) Security middot Doors shutters of the pharmacy should be strong and be fitted with secure locks middot Counters should be designed so that unauthorized personnelclients do not have

access to areas where prescription medicines are stored Access to such areas should be restricted to the pharmacy staff

middot All the pharmacy staff handling supplies should be accountable for their ac t i o n s

56

middot bullSpecial care must be taken in case of Schedule X and manufactured drugs (under NDPS Act) Such medicines should be kept under lock and key and the key should be kept with the Chief Pharmacist or i n h i s a b s e n c e t h e s e n i o r p h a r m a c i s t

v) Breakagespillage and damaged product Products that have been damagedspoiled during storage and handling spillages and broken glassware should be disposed off according to procedures laid down by the pharmacy Broken and damaged products s h o u l d b e p l a c e d i n a segregated area to be returned to the supplier

vi) Inspection Senior staff should inspect all pharmacy areas regularly The shelves and drawers should b e c h e c k e d d a i l y f o r signs of pests and dust Ceiling and walls should be checked for dirt and cobwebs Stock should be checked on a regular basis for deterioration due to climatic conditions

43 Product recalls Products found to be defective should be quickly recalled (withdrawn from the market) The instructions are generally issued either by the manufacturer or the regulatory agency The level of recall is determined by both the degree of risk and the extent of distribution of the product and in India is mainly directed at the distribution chain

On receiving the details of the defective substandard spurious batchbatches of a medicine to be recalled from the manufacturer or the stockist or the FDA the pharmacy should immediately check if the particular b a t c h i s i n s t o c k a n d i f s o s u s p e n d i t s s a l e immediately

Similarly if the regulatory authority in the country bans a particular medicine or FDC the pharmacy should immediately check and remove all the different brands of that particular medicine under consideration

The details of medicines and their batches to be recalled should be available in the q u a r a n t i n e a r e a w h e r e stocks are received and checked This is to ensure that such medicines do not come into the pharmacy

middot The pharmacy should develop SOPs for recall of medicines middot The pharmacy staff should be immediately informed about such medicines and

the details should be displayed in writing in a prominent place in the pharmacy middot Rapid action helps avoid unnecessary exposure to such medicines once the

problem has been d e t e c t e d middot The progress of the recall procedure in the pharmacy should be monitored every

few days to ensure complete compliance middot All stocks of the recalled products should be stored separately from the saleable

stock These can be stored in the expiry cupboard segregated from the expired goods and be appropriately labeled ldquoRecal l e d G o o d s - Not for Salerdquo

The supplier should be notified and asked to replace defective products middot All the details of the procedures followed should be duly recorded in a Recall

Register maintained specially for the purpose The register should include d etails such as -middot Date of the recall middot Nam e of the product

57

bullbull

middot Details of the product (name of manufacturer batch number expiry date) middot Nu m b er of units purchased sold a n d sto c k in ha nd middot Reason for recall middot Nam e of the supplier to whom produc ts w e r e returned along with the date and quantity middot Name and signature of the designated personnel carrying out the recall procedure and recording details middot Name and signature of the chief pharmacist verifying the recall procedures and recording details 4 4 Returned medicines

Medicines may be returned to the pharmacy by clients due to the following reasons -bull

bullbull Unused medicines bullbull Course not completed bullbull Therapy changed by doctor bullbull Side effects experienced by patient bull

bullbull DamagedDefective medicines bullbull Missing or defaced label bullbull Missing tablets in a stripblister bullbull Leakage in bottles bullbull Leakage in strips bull

bullbull Expired medicines

Appropriate SOPs should be framed and followed for their acceptancerefusal and disposal middot bull For unused medicines returned by clients the p harmacy personnel should verify

that these were purchased from their pharmacy They should then be checked for integrity of the packing the dosage form and the expiry date and verified with the client whether they were stored in appropriate conditions This again is at the discretion of each pharmacy

middot The damageddefective medicines returned to the pharmacy should be taken back and stored separately Existing stock of the same product should be checked for similar defects

middot Expired medicines should be accepted from clients at the discretion of the pharmacist and be immediately shifted to the expired goods cupboard These can be stored segregated from the pharmacys own expired goods and be appropriately labelled ldquoExpired Goods returned by clients- Not For Salerdquo

It is advisable not to accept returned medicines requiring cold chain storage (refrigeration) because it cannot be ensured that the cold chain was maintained when the medicines were in the hands of the patientclient middot Appropriate adjustments in t he stocks should be made for medicines

returnedexchanged to update the inventory middot The medicines should then be returned to the respective shelves middot A lsquoReturned Goodsrsquo register needs to be maintained to record all details of returned

medicines

R egister should include such details as-

58

middot N a m e o f t h e p a t i e n t middot Nam e of the product and quantity r e tu r n e d middot Product details such as the batch number and expiry date middot Condition in which received middot Reason for returning products middot Compensatory measures taken wi t h r e s p e c t t o c l i e n t middot Action taken with respect to product middot Name and signature of the personnel accepting the returned medicines and recording details middot Name and signature of the chief pharmacist verifying the recorded details

What the pharmacist would have learnt from this module The storage of medicines is a critical factor in the distribution cycle bullbull Stocks received by the pharmacy should be quarantined in a separate area and necessary checks s h o u ld be performed to ascertain the qua lity a nd quantity of stocks received bullbull Whatever pattern and means of storage used the products should be stored so as to maintain their potency and integrity bullbull Storage conditions should be monitored and maintained on a regular basis bullbull Optimum stock levels should be maintained and regularly monitored for expiry bullbull The design of storage areas should facilitate appropriate storage of medicines bullbull Cleanliness should be maintained in the pharmacy bullbull Adequate measures should be taken in case of returned medicines and recalled products

Optimum storage of medicines is mandatory whether at the distribution stage at the pharmacy or ultimately within the homes of patients The pharmacist has an important r o l e t o p l a y i n t h e s t o r a g e o f m e d i c i n e s i n m a i n t a i n i n g d r u g p o t ency and efficacy and thus facilitating optimum therapeutic benefits Good Pharmacy Practice - IPA -CDSCO - WHO Appendix I Quality Assurance Templates of letters for use if found not of Standard Quality [Frozen and expired goods ]

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated To Name of the Supplier with address

Sub Not of Standard Quality GoMP-Supply of Drugs and medicines-(Codename) Return of Stocks to the Suppliers-reg(New drug policy 2009) Previous letterinvoice ref Sl No Drug Code Drug name

Manufacturing date Expiry date

Supplier address

B a t c h n o

The above items of PO nodated was drawn by the Drug Inspector (Place) on (______________date) as a statutory sampling and declared ldquoNot of Standard

59

Qualityrdquo on -(______________date) by the Government Analyst for the following reasons

- ldquoThe product sample do not confirm to IP specification for (Drug codename with respect to the content of drugrdquo

- ldquoThe product has already been blacklisted by TNMSC on -(______________date) for the failure of (quantity) of batches of drug codenamerdquo

As per the clause of the te nde r d oc um e nt ldquo I f the sa mple s d o not c onf o r m to statutory standardsthe tenderer will be liable for relevant action under the existing laws and the entire stock in such batch should be taken back by the tenderer within a period of 30 days o f t h e r e c e i p t o f t h e l e t t e r f r o m t h e v e n u e

The stock shall be taken back at the expenses of the tendererthe Procurement Authority have the right to destroy such Not of Standard Quality if the tenderer does not take back the goods within the stipulated time

The Procuring Authority will arrange to destroy the Not of Standard Quality drugs within 90 days after the expiry of 30 days mentioned above without further notice and shall also collect demurrage charges calculated at the rate of 2 per week on the value of the drugs rejected till such destructionrdquo

Hence we regret to inform you that you will have to take back the stocks available of the abovesaid batch at your own cost from the drug stores where you have supplied the above batch

Kindly acknowledge the receipt of this reference at once

P r o c u r e m e n t A u t h o r i t y Seal and Stamp

Copy to Ref No dated

1 ) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated13082010

To

Sub Frozen Drugs-ordered to return to the Suppliers-reg(New drug policy 2009) Previous letterinvoice ref

The following products which were earlier frozen have now been ordered to return to suppliers directly with permission from the State drug Authority In this regard the suppliers have been instructed to take back their failed batch from the drug store of the stores Hence you are now instructed to return the following failed batches to the suppliers by obtaining proper authorization letter and acknowledgements from them

60

Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

Kindly acknowledge the receipt of this reference at once

Procurement Authority Seal and Stamp

Copy to

Ref No dated 2) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated14092010

To

Sub Frozen Drugs-ordered to return to the Suppliers- for issue of gate pass after verification reg(New drug policy 2009) Previous letterinvoice ref

The following products which were earlier frozen have now been released Hence they may be issued Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

Kindly acknowledge the receipt of this reference at once

Procurement Authority Seal and Stamp

Copy to

61

Ref No dated 3) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated

To

Sub Stop instruction-reg(New drug policy 2009) Previous letterinvoice ref

Until further instructions stop issue all the batches of the following item Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

You must intimate the available stock in the stores of the said batch Number to the Procurement Authority immediately Also retrieve quantity if already issued

Procurement Authority Seal and Stamp

Copy to

Ref No dated 4) HOD Procurement Office of

62

Appendix II Material handling in drug stores

Rack approx rates and dimensions

S No

Item Description UOM Approx Rate

1 MEDIUM DUTY RACK SIZE 2900 H X 3090 W X 800 D IN MM (AS PER SPECIFICATION)

Each 2499800

2 MEDIUM DUTY RACK ADD ON UNIT FOR SIZE OF SR NO2

Each 2243100

To locate a Box no 3 Rack no 14 in row3

SAMPLE OF RACK no Bin numbering -------------- S a y R K 1 4 R o w 3 B o x 1 6

SAMPLE LAYOUT of RACKS in a Drug Stores

63

Sample of another warehouse of distribution warehouse system

64

65

Slotted Angle racks with bin cards

66

Plastic Pallets

Plastic pallets ar e l i g h t w e i g h t l o w- c ost and exceed industry standards for strength and durability

NOTE A pallet has bottom deckboards (see sketch) A skid does not have bottom

67

deckboards

Battery Operated Stacker

Electric Stacker Ehh (Manual Push Type) - Manual drive - Lifting electrically with Battery 12 V 88 Ah - For loading and un-loading of trucks - Battery and loading device built - in - Battery charge gauge and charging current gauge Simple and Easy Operation - Lifting and Lowering electrically direct on steering arm - Pulling and pushing through steering arm - Electrically operated relief valve on hydraulic aggregate Safe Operation - Emergency Off Switch - Constant lowering speed - Protection through lowering brake valve - Overload protection through overload brake valve - Load chains covered preventing pinching threat - Electrically interlocking during loading process - Secured battery compartment opens upwardly - Stable buffering of the steering arm in upright position - In accordance with EWG Guidelines 89 240 - In accordance with VBG 12b Prevention of Accidents

Pallet Truck [ Top ]

68

----------------------------------------------------------------------------------------------------------------------------

For Transport Of All Goods On Pallets Safe and Easy Operation - through single hand operation Lifting moving

lowering with steering handle - neutral position of the hydraulic possible - overload pressure relief valve Long Service Life - robust co n s t r u c t i o n

- special hardened axles - hardened chromium plated ram - maintenance free Easy Maneuverability - through rubber steering rollers - nylon fork rollers

A h a n d t r o l l e y

69

Trolley with plastic bins for several items del ivery

70

Digital Weighing balances

Balances amp Scales EF Seriers Precision Electronic Balance

71

1

Ice lined Refrigerators

600 litres refrigrator

72

Walk in cooler

vacuum cleaner

73

1 QUARANTINE AND CHECKING OF STOCKS

11 Quarantine Area D r u g S t o r e pharmacies receive stoc k s f r o m su pplie r s a c c or d ing to pur c h a se o r d e r s T he stock that is received must be visually checked for quality and quantity The stocks must be kept in a separate area until the checking is done to avoid intermixing with existing stock This necessitates the presence of a separate area within the pharmacy w h e r e i n t h e storage and other checking of stocks can be performed This area is called the QUARANTINE AREA This area should be marked and identified adequately to distinguish it from other areas

The area may be marked using different means 1 ) A s m a l l board saying Quarantine on a separate table used exclusively if it is in the middle 2) A board on the wall if the table on which the quarantine stock is placed is against the wall

middot Stock received from wholesalers should be immediately transferred t o t h e Quarantine Area

middot In the Quarantine area the stock may be stored on racks shelves or in cupboards to prevent ingress of moisture dirt and other contaminants

middot Regular stocks from the pharmacy should not be left kept in the quarantine area Special care has to be taken in case of refrigerated medicines supplied by the suppliers so tha t the y do not remain in the quarantine area for long periods of time They should be immediately checked on receipt and transferred to areas for refrigerated storage s o a s to maintain the cold chain bull

Advantages of having a separate Quarantine Area middot Avoids cross mixing of newly arrived stock from existing stock till it is checked middot Lays stress on checking the quality of the stock received middot S to ck checking ensures t hat defective andor expired goods do not enter the storage areas

34

bullbull

bullbull

12 Checks to be carried out on new stock

Unpacking and checking stock

Supplies received should be unpacked and checked in the quarantine area Staff doing the checks should be adequatel y trained in what they have to check when stock arrives

Checking should be seen not simply as counting the units received but as a part of the quality assurance system bullThis should include middot Visually inspecting the packaging middot Checking the integrity of containers middot V erifying the completeness and leg ibility of la b e ls ( a ppr o ve d dr u g name strength any special storage instructions and expiry date)

bull

The expiry dat e should be checked to ensure that there is adequate shelf life remaining

Supplies should be individually checked using a checklist 35

Checklists

36

The wholesaler supplying the product should be notified immediately in case of any discrepancies ( and the details should be recorded in a register) and sent in a written format to the supplier It should include middot Missing boxes or cartons middot O p en tampered boxes or cartons middot Missing supplies middot Differences in the actual quantity and the quantity shown on the packing middot Additional medicines that had not been ordered but have been supplied middot D a m a g e d b r o k e n o r p oor quality medicines middot Any other discrepancies

The purchase invoices are an important aspect to be considered The invoiced documents should be signed and filed for reference as per the Drugs and Cosmetics Act and retained for at least 3years

If the wholesaler supplies medicines as an emergency without a bill or against a delivery challan

middot The supplies should be checked for integrity and inspected for damage middot The details of supplies received should be recorded middot The supplier should be asked t o send the bill as early as possible middot When the bill is received it should be checked against the details recorded and anomalies if any should be reported to the supplier

To keep a track of the received stock maintaining a S t o c k R e c o r d C a r d c a n b e very useful The entries in the stock record card can be made while checking the stock received STOCK BIN in the stores should have Stock record card

Maintaining a stock card for every product may not be very practical for a retail pharmacy however it could be maintained for costly medicines Nowadays it is much more practical and easier to maintain records using computers

The pharmacist should ensure that medicines manufacturedmarketed by a company are received only through an authorized distribution network of that company This is important to prevent spurious and counterfeit drugs from entering the pharmacy

37

2 STORAGE 21 The need for proper storage The storage of medicines and other products is an important requirement of Good Pharmacy Pr actice Appropriate storage of medicines is essential -

middot bullTo ensure that the potency is maintained middot bullTo prevent deteriorationspoilagedegradation middot bullTo ensuremaintain physical integrity

To ascertain that the quality and safety is maintained throughout their shelf life Storage requirements need to be considered on 2 aspects

a) Integrity of medicines Medicines should be stored in such a way so as to maintain their integrity and potency middot Maintain the right temperature required middot Protect from excessive humidity middot Keep medicines away from direct sunlight middot Protect from pests and rodents

b) Physical location middot Should be easy to locate middot Accessible middot Orderlysystematically placed

2 2 D i f f e r e n t p a t t e r n s o f s t o r a g e The pharmacist could follow any of the different patterns of storage The pattern of stora ge should be selected in such a way that it facilitates speedy and efficient dispensing of medicines

The pattern of storage could vary with each pharmacy experience usual practiceroutine of staff and the person-in charge and also depending on space av ailable turnover etc (i) The medicines could be stored c o m p a n y w i s e ie the medicines manufactured by one company should be grouped together and kept in one place Within each company shelfshelves the medicines may be placed in alphabetical order for easy and quick placement and removal Also bottles tubes boxes etc may be segregated within that shelf

38

(ii) The medicines may also be stored in a lphabe t ic al o r de r ie they are placed in order from left to right based on their name The first letter of the name is used to g r o u p t h e m e d i c i n e s t o g e t h e r a n d k e e p t h e m i n o n e l o c a t i o n I n s o m e p h a r m a c i e s a l l t h e strip packing are placed in drawers or boxes in alphabetical order each box or drawer containing strips of one particular alphabet This system ensures that the strips always remain e n c l o s e d i n t h e b o x e s d r a w e r s a n d a r e n o t e x p o s e d t o d u s t T h e d i s a d v a n t a g e i s that it might lead to mix -u p o f strips in the same drawer and it may cause a problem incase of similar looking strips in which case a wrong medicine may be dispensed Secondly cut strips lying around in the drawer may lose their identity if the batch n u m b e r andor expiry date is not seen on the cut portion of the strip

39

(iii) The medicines may be stored according to their therapeutic class ( e g a n t i b i o t i c s anti asthmatics or anti hypertensives) ie the medicines are kept together based on their pharmacological or therapeutic action

(iv) The medicines may be stockedsegregated according to dosage forms eg l i q u i d s (bottles) solid oral dosage forms eye drops rotacaps ointments etc all stored on separate shelves

Always Remember I Storage of prescription medicines should preferably be separate from OTC medicines OTC medicines especially those that a r e a d v e r t i s e d m a y b e d i s p l a y e d f o r c l i e n t s t o select or to ask questions about [OTC-O v e r t h e c o u n t e r ] II Storage according to temperatures is a must no matter which pattern of storage is followed Also within a particular storage area segregated storage may be maintained In a refrigerator for example medicines may be stored in trays racks and the freezer according to the temperature required

40

Whatever pattern of storage is selected all the personnel should ensure that middot The stocks are stored in an orderly manner middot The medicines are kept back in the same place from where they were removed middot All medicines are arranged neatly once in a while

middot The personnel should be careful while storing the medicines middot They should not throw the medicines haphazardly 23 Different means of storage

middot Within each temperature and security zone medicines must be stored so that they are easily accessible and protected against damage

middot Basic means of storage include shelves racks and drawers middot To prevent dust from entering the shelvesracks it is ideal to have glass

shutterssliding glass doors This can however be disadvantageous because accessibilityspeed is hampered in removing a product from the shelf because the glassshuttersliding glass has to be

41

opened m o v e d e v e r y t i m e a p r o d u c t h a s t o b e p i c k e d u p U s e o f a i r c o n d i t i o n e r s f o r t h e p h arm acy with a closed door at the e n t r a n c e o r a n a i r c u r t a i n c a n r e d u c e t h e d u s t problem In such cases the shelvesracks may be left o p e n

bull

middot Direct storage of cartons on the floor should be avoided because besides being an unhealthy practice the contents may also be damaged by moisture bull

middot Store medicines preferably in shelves with glass shutters for visibility middot Closed shelves further prevent dust from going in especially in India where most

pharmacies are located along busy roads middot Some medicines have to be refrigerated or stored in a cool or cold place Having a

refrigerator or two (as per the need of the pharmacy) is essential to store suc h medicines at temperatures mentioned on the label bull

42

Refrigeration middot All cold chain equipment should meet required standards middot Improvement in refrigeration technology has provided frost -free refrigerators

Pharmacists should opt for frost-free refrigerators as they are easy to maintain and protect printed packaging materials Conventional refrigerators may cause water falling from trays below the freezer on medicines stored in the refrigerator thus causing soggy labels

middot bull Frost-free refrigerators also provide separate and large compartments for the freezer portion (required for storing medicines needing sub-z e r o t e m p e r a t u r e ) and the main storage area with separate doors so that opening one door does not disturb the storage temperature in the other compartment

Care should be taken to keep the refrigerator on 24 hours a day It should not be switched off after working hours It is advisable to have an inverter connected to the refrigerator so that the refrigerator re mains working even when there is a power outage

middot The refrigerator door should be closed tightly middot The refrigerator door should not be left open for too long middot Space should be left between medicines stored in a refrigerator to allow air to

circulate middot The ref rigerator should be placed about an arms length away from the wall

This will increase air circulation thus not affecting the cooling within the refrigerator

middot Vaccines should not be stored on refrigerator door shelves as they are exposed to warmer temperatures each time the door is opened Vaccines should always be stored on the middle shelves of the refrigerator

middot Refrigerated medicines should not be left out of the refrigerator for more than a few minutes

43

middot Consumable products like juices energy drinks e t c s h o u l d n o t b e s t o r e d a l o n g with medicines in refrigerators If required they may be kept in a separate refrigerator

middot An adequate number of refrigerators should be planned to store the entire stocks requiring refrigerated storage

middot Adequate procedures should be followed for defrosting cleaning and maintenance of refrigerators

middot Icefreeze packs should be kept in the freezer compartment so that they can be used for transporting cold temperature medicines The packs can be given to clients along with the medicines requiring cold temperature storage so that the temperature is maintained till the client reaches home and can then put the medicines in a refrigerator) Freezer packs can also be used to keep medicines temporarily in case there is a power outage or refrigerator breakdown

Activity

Prepare a SOP (Standard operating procedure chart) for cleaning a refrigerator Discuss it with your staff finalize its maintenance once a month through AMC -A n n u a l Maintenance contract CMC - Comprehensive maintenance contract and put it up on the pharmacy refrigerator Put the Purchase Order details name of manufacturer Phone of Service Engineer and a register to login the Machine service and down timeService reports may be maintained properly

Refrigerator monitoring and maintenance

middot bullIt is important to carry out routine monitoring and maintenance of the refrigerators and to organize an effective repair system

middot bullThe temperature in the refrigerator must be monitored and recorded routinely at least once a day

middot Any breakdown must be reco rded including the period during which the medicines were exposed to uncontrolled temperatures Medicines may then be kept or discarded depending on the problem guidelines or the manufacturers advice

middot Cold chain monitor cards and devices in or on packages that change color or otherwise alert staff to potential damage assist in monitoring (These are likely to be introduced in India soon)

middot It is essential to have a contingency plan in place before a refrigerator breaks down An arrangement can be made to move the contents to a private refrigerator elsewhere in the community or to obtain a regular supply of ice packs until the defect is rectified

Put filled water bottles in the bottom half of the refrigerator door in order to provide cooling in the refri g e r a t o r w h e n t h e r e i s a p o w e r o u t a g e T h i s m i g h t t a k e c a r e o f t h e temperature when there is no current for a couple of hours If the power outage is expected to last for several hours special arrangements such as an inverter UPS have to be made to keep the refrigerator constantly running in the absence of electricity middot Defrost the refrigerator in case of excessive ice formation and preferably at regular

intervals Keep a record of the same

44

2 4 T e m p e r a t u r e c l i m a t i c c o n d i t i o n s

i) Temperature control middot The medicines in a pharmacy need to be stored at appropriate temperatures to

maintain their stability middot An air-conditioned environment where temperature can be controlled is

recommended for pharmacies Air conditioning offers the option of setting the t e m p e rature as per requirements

middot bullIt is ideal to have an air conditioner to maintain the temperature below 25 C as most medicines require storage below this temperature Secondly this temperature is pleasing to both the staff and the visiting customers too

middot In the absence of an air conditioner circulating fans may be used middot This need is felt even more in certain parts of India where temperatures soar above 45

C and some areas where it falls to sub zero temperatures In such cases temperature maintenance is essential to prevent deterioration of medicines due to unnecessary exposure to drastic temperature fluctuations

middot This need is felt even more in certain parts of India where temperatures soar above 45 C and some areas where it falls to sub zero temperat u r e s I n s u c h c a s e s temperature maintenance is essential to prevent deterioration of medicines due to unnecessary exposure to drastic temperature fluctuations

i i ) Humidity or moisture control Moisture or humidity can adversely affect the stability of me dicines such as tablets capsules powders

45

Gelatin capsules become soft and swell on absorption of moisture The drug content of tablets may undergo surface hydrolysis The presence of moisture may encourage the growth of microbes It is therefore essential to control humidity

To reduce the effect of humidity the following suggestions may be followed -middot Open the windows to allow air circulation Use a fan to circulate fresh (outside) air middot In humid climate a dehumidifier is useful for preventing mo i s t u r e d a m a g e ( i n t h e absence of an air conditioner) middot For bulk containers of tabletscapsules do not keep the container open for a long time and replace the lid or closure immediately after taking out the required number of medicines for dispensing middot Do not allow the medicines to touch the floor or the walls The walls may be damp and may cause moisture absorption damaging the product

middot Calibrated thermometers and manometers can be used to detect temperature and humidity in the pharmacy

middot Periodici t y of checking the temperature should be fixed middot The climatic conditions should be recorded and documented middot Temperature charts should be available for ready reference

Documentation is one of the core activities for achieving and maintaining quality It is one of the most essential components of validation Temperatures in various areas

46

including refrigerators should be recorded at a predetermined periodicity usually daily at the hottest time of the day and such documents should be preserved i i i ) Storage conditions A number of storage conditions are mentioned on the labels of medicinal products These conditions have to be properly interpreted and appropriately complied with

According to the Drugs and Cosmetics Rules 1945

1 The term cool place means a place having a temperature between 10 C and 25 C

2 The term cold place means a place having a temperature not exceeding 8 C In case of storage conditions for specific products please refer to Schedule P The Drugs and Cosmetic Rules 1 9 4 5

The Indian Pharmacopoeia specifies the following storage conditions -

Wherever the condition for storage is not specified medicines may be stored under normal temperature In a country like India however where normal temperatures soar to h i gh temperatures it is recommended that medicines be stored in a cool place

Activity Prepare a list of the storage requirements mentioned on the label of about 20 products in your pharmacy and check if the temperature is maintained

47

25 Special Storage o f s u p p l i e s If the product has no special instructions normal storage conditions apply This means storage in dry clean w e l l -ventilated premises at temperatures of +15 C to +25 C or depending on the climate up to +30 C (WHO1990) Storage instructions are product specific Different brands of the same generic drug may have different storage requirements as they may have different packaging or formulations It is essential to follow the product manufacturers storage instructions to the maximum extent possible Less stable medicines must be stored in specific conditions to maintain their quality or potency

The following products require special storage facilities

middot Products that must be kept frozen (usually vaccines and sera) middot Products sensitive to h eat an d r e q uir in g r e f r ig e r a tio n ( +2 C to +8 C) middot Products that have reduced shelf life at uncontrolled room temperature and need

mechanical ventilation or air conditioning middot Flammable products that require separate fireproof premises middot Products prone to theft o r m i s u s e

Products needing storage in a controlled environment -

The usable shelf life of the following products may be reduced if stored at uncontrolled humidity or at room temperature in hot climates -

middot Some injectables (eg adrenaline) Most injectable preparations are less stable than solid oral forms (tablets and capsules) Injectable preparations in solution are particularly unstable Many injections must be protected from light as well as heat

middot Intravenous fluids (particularly if packed in p lastic containers) middot Some suppositories pessaries creams and ointments These products may melt at

temperatures greater than 30 C Once this happens it is not advisable to use them because the active ingredient in the formula may get unevenly distributed

middot Products containing rubber latex cellulose or some plastics Condoms most sterile disposable medical devices and surgical products such as syringes needles and catheters require protection from excessive humidity and strong light and heat Any o f these conditions may make products brittle stained amp unusable Sterility cannot be assumed if packaging is damaged

In hot climates these products should be stored in the coolest place possible preferably with air conditioning or air circulation fans

48

Products needing freezing or refrigeration-middot Vaccines blood products and many other medicines lose potency if kept even for a

brief period at temperatures outside the recommended range For these products the cold chain must be maintained at every stage of the distribution system

middot Freezing is as damaging as high temperatures for some products including injectable contraceptives ergometrine insulin adrenaline and the DPT DT TT and Hepatitis B vaccines Such products therefore sho uld not be allowed to freeze (not be kept in the freezer compartment)

middot Short periods at room temperature (during transportation or local distribution for instance) may be acceptable for many products (such as ergometrine a n d i n s u l i n ) e v e n t h o u g h s u c h e x posure can to some extent reduce shelf life Other items such as vaccines should always be transported in cold boxes

Storage of insulin injections-

middot Insulin should always be stored in a refrigerator at the recommended temperature of 2 -8 C

middot Insulin should not be kept in the freezer compartment of the refrigerator middot Insulin should ideally be stored horizontally middot It should not be exposed to sunlight or excessive heat middot Insulin suspensions should not be used if the suspension cannot be properly

resuspended due to cake or clump formationbull

Controlled drugs -Narcotics (for example Pethidine injection morphine preparations) and other specified drugs that may be abused are governed by special legislation and regulations The following security measures are suggested in the pharmacy -middot A safe or reinforced double locked cabinet fitted with a light (preferably with a red

bulb) that comes on when the door is opened

49

middot A special register recording details of each receipt or issue with 2 signatures physi cal counting of medicines after each entry and signatures at handover takeover

middot Independent audit (by supervisors and drug inspectors)

Products prone to theft abuse or misuse -

Some medicinesproducts are particularly prone to theft abuse or misuse These include expensive medicines (eg insulin) certain antibiotics and products prone to abuse or misuse like psychotropics etc

Such medicinesproducts should be stored adequately They require stricter record keeping and more frequent stock taki ng than others Periodic audits should be carried out to check for consumption against actual recorded use (registers prescription records stock records etc) to expose any theft or misuse bull26 Storage and stability of medicines Medicines are not stab le indefinitely They are stable for a specific period of time sometimes for a brief period Poor storage conditions accelerate the drug degradation (decomposition) Temperature light and moisture are the most important contributing factors for drug instability It is important to identify and be aware of the potential for instability There is a need to comply with storage requirements to ensure quality medicines for patients It is also important to offer advice to patients too about appropriate storage o f medicines at home The dispensing label should state the storage condition required and be backed up by a verbal reminder especially where special storage is required bull

50

In case stability and storage problems are seen with formulations they should be reported immediately to the representative of the manufacturer and taken out of circulation till the stability problems have been resolved

The pharmacist can easily detect stability problems when products show change in appearance color odor settling of the product contents breaking of emulsions melting of creams oozing of contents from the containers and any such physical changes

3 STOCK CONTROL AND EXPIRY MONITORING 3 1 S t o c k C o n t r o l For economic reasons pharmacists do not like to have stock on their shelves for long periods of time The aim should always be to keep stock at a level that will just meet demand Normally most manufactured medicines have a long shelf life Even then it is essential that there is efficient stock rot ation so that the older stock is used first It is also a good practice to check the expiry date as an integral part of the dispensing process When short shelf life products are involved stock levels may have to be modified to prevent medicines regularl y expiring on the shelves

32 Stock rotation and expiry monitoring In order to avoid accumulation of expired and obsolete stock medicines should be stored and issued according to the following guidelines -middot The stock control system must record the ex p i r y d a t e a n d t h e d a t e o f r e c e i p t middot Stock must be stored so that earliest expiring batches are picked and issued first middot The First In First Out (FIFO) system - In this system the stock which is received

first is sold first This system however may not be useful for pharmacies because most of the stocks carry an expiry date For pharmacies the FEFO system is more practical

51

middot The First Expiry First Out (FEFO) system - In this system the stock having an earlier expiry is sold first The stock with longer shelf life should be placed farthest to the back (or at the bottom in case o f sta c k e d b oxe s) T h is is pa r tic u la r ly impor ta n t with products that have short shelf lives such as vaccines some vitamins antibiotics etc and reduces losses due to expiry

middot E x p i r y dates should be noted on the stock record upon receipt Stock nearing expiry should not be accepted unless it can be used before expiry

Computerization and expiry monitoring In the pharmacy computerization facilitates both checking stocks and expiry mo nitoring and helps-bullbullKeeping a check on products nearing expiry bullbullKeeping a check on non- moving and slow moving products bullbullTo facilitate the removal of medicines nearing expiry from shelves in time to send them back to the wholesaler or supplier

Periodic checking for expiry The expiry date for medicinal products is a critical aspect in pharmaceutical dispensing and due importance should be given to it Periodic checking for expiry of medicines will ensure that the patient will never receive products that have crossed their expiry date During periodical checking of expiry the personnel involved should remove medicines that are nearing expiry bullbullIn -house threshold periods should be set and followed for retrieval of such medicines from the shelves bullbullSuch medicines should be stored separately These should either be dispensed immediately (thus ensuring that they are used before the expiry date) o r t h e y s h o u l d b e returned to the suppliers bullbullA separate area should be designated (cupboard or shelf)marked[FROZEN ZONE] which is adequately marked EXPIRED GOODS- NOT FOR SALE to store all expired stocks FROZEN ZONE

52

Remember Expired medicines are a NATIONAL WASTE So stock only what you can sell Avoid expiries save precious medicines for the nation

Treatment and disposing of expired medicines bullbullProcedures need to be in place for the treatment of expired medicines bullbullThe expired medicines need to be collected and be sent back to the supplier or company for appropriate disposal bullbullRecords must be maintained for expired medicines and how they are disposed off bullbullIn case of medicines that are not returnable to suppliers procedures for disposal need to be followed by the pharmacy in conjunction with the FDA The following procedure can be followed if medicines cannot be returned to suppliers ( T h e b a s i c p h i l o s o p h y of appropriate disposal is to prevent their re- circulation and use) bullbullC u t t h e c o n t ainer in such a manner that the label is also cut In case of tablets and c a p s u l e s d e s t r o y them by disposing them in a bucket of water bullbullUse landfill procedures (deep burial into the ground as per stipulations of Medical Waste Disposal Act prevalent in the respective state) bullbullPour the liquids into the sink and wash away with sufficient quantity of water bullbullKeep a record of such disposal with full details of medicines destroyed Although these measures are usually adopted care has to be taken with such tr e a t m e n t a s studies have shown that flushing of medicines has resulted in tracessmall quantities of medicines being found in waterways and groundwater having potential health and environmental effects

4 O T H E R A S P E C T S 41 Design of storage areas The following important factors need to be considered in design of storage areas -middot The retail outlets in hot areas in summers should be air-conditioned Similarly in

a r e a s o f e x t r e m e c o l d t h e p r e m i s e s w o u l d r e q u i r e w a r m i n g e s p e c i a l l y i n w i n t e r s t o maintain cool temperatures The placement of air -conditioners and heating devices should be such that medicines are not directly exposed to the cold or heat

middot Due consideration should be given to storage requirements of formulations while designing shelves and cupboards in retail outlets Sufficient shelf height should be provided so that all liquid products can be stored vertically As far as possible the shelves should be covered with glass panels to protect medicines from dust and p r e v e n t r a p i d f l u c t u a t i o n s i n temperature

middot Medicines should be stored according to the storage instructions on the labels bullIt is ideal to have a door at the pharmacy entrance to prevent dust from coming in as well as reduceprevent cooled air from going out This may not however be considered feasiblepracticable by many pharmacy owners for fear that clients may not enter the pharmacy because the door may act as a barrier An air curtain is a good alternative to a door

middot There should be minimal direct sunlight falling on the products Particular consideration should be given to premises directly facing the sun

middot bullThe arrangement of lighting in the interior of the premises should also be in a manner that the lights are not focused on the products It has been shown that light causes not only chemical damage but also can catalyze physical changes like moisture uptak e by the products Care should be taken to ensure that only diffused light falls on them

53

middot As far as possible provision should be made for a temperature and humidity indicator device in a pharmacy These devices are now easily available

middot Stability studies o f m e d i c i n e s p a c k e d i n b l i s t e r s h a v e r e v e a l e d t h a t i f t h e s e a r e exposed to light they tend to absorb moisture It is therefore necessary to store them in suitable cartons so that the blisters are not exposed to light Pharmacists should do this even if the manufacturer has not provided cartons

middot Light and temperature sensitive products should not be stored on counters where the light is intense or direct and there is no protection from temperature and humidity

42 Cleaning and maintenance i) Cleaning of storage areas

The storage areas of the pharmacy should be cleaned periodically and cleanliness should be maintained at all times The Standard Operating Procedure for cleaning should be designed and followed accordingly Schedules for cleanups should be laid down and adequate cleaning equipment should be made available

Tips for maintaining cleanliness middot Provide clean pieces of cloth for wiping at various locations in the pharmacy

Replace with clean cloth at regular intervals middot Keep separate pieces of cloth for floors shelves and medicines middot Use a disinfectant andor soap solution to clean floors middot Ensure removal of dust and prevent accumulation of dirt middot Ensure removal of cobwebs middot Use a vacuum cleaner for cleaning areas not easily reachable middot T a k e c a r e t h at breakages are handled and cleared effectively middot Observe the factors leading to waste generation in the pharmacy and take appropriate

measures to tackle the problem middot Record all cleaning procedures performed and maintain all the documents required

For ex a m p l e -bullbullThe floor of the pharmacy may be swept with a broom and swabbed with soap water every morning bullbullThe floor may be swabbed with a disinfectant every week bullbullThe entire premises including shelves and cupboards may be cleaned with a cloth (to remove dust and to check for medicines approaching expiry date or expired medicines) every three months bullbullAll the steps followed should be r e c o r d e d

The floor shelves drawers have to be cleaned and a check should be kept on dust cobwebs spillages due to breakage etc It is therefore essential to have SOPs for cleaning laying down cleaning frequencies allotting responsibilities and maintaining a daily record in the logbook to document all these activities

54

While cleaning dust settled on dosage forms like bottles tubes etc should be removed Before dispensing the products should also be wiped to remove any dust settled during storage

For refrigerators bullbullDefrosting and cleaning should be done at regular intervals bullbullSwitch off the refrigerator while cleaning bullbullCleaning should be done quickly and stocks put back immediately

i i ) Pest control Pests are a serious problem in India where insects reptiles and rodents (eg cockroaches l i z a r d s r a t s s i l v e r f i s h (Deemak - in Hindi ) etc) may find access to the pharmacy storage areas Insects like ants and borer ants may often attack wood in the pharmacy causing d am ag e to shelves cupboardsPest c ontr o l in a p h a r m a c y c a n b e a d i f f i c u l t t a s k b u t t o avoid possible contamination and physical damage to stock it is necessary to keep pests out of the pharmacy premisesPest control measures should be implemented with proper p r e c a u t i o n s t a k i n g u t m o s t c a r e t o a v o i d contamination of medicines

55

Th e following pest control measures c a n be ta ke n f r om tim e to tim e -bullbullRat bait and traps can be placed at various locations bullbullInsecticutors can be used on a permanent basis bullbullInsecticidal sprays and repellants can be used from time to time

i i i ) Fire precautions

Combustible trash such as cartons boxes and other packing waste must not be allowed to accumulate in the store Waste should be deposited in appropriate waste bins and be d i s p o s e d o f f o n a d a i l y b a s i s

F i re detection and fire fighting equipment must be maintained and regularly inspected The pharmacy personnel should receive adequate training in fire fighting techniques and emergency actionFire prevention measures should include a prominently displayed ldquoNoSmokingrdquo sign careful handling and disposal of combustible waste materials and checking of electrical connections at regular intervals

iv) Security middot Doors shutters of the pharmacy should be strong and be fitted with secure locks middot Counters should be designed so that unauthorized personnelclients do not have

access to areas where prescription medicines are stored Access to such areas should be restricted to the pharmacy staff

middot All the pharmacy staff handling supplies should be accountable for their ac t i o n s

56

middot bullSpecial care must be taken in case of Schedule X and manufactured drugs (under NDPS Act) Such medicines should be kept under lock and key and the key should be kept with the Chief Pharmacist or i n h i s a b s e n c e t h e s e n i o r p h a r m a c i s t

v) Breakagespillage and damaged product Products that have been damagedspoiled during storage and handling spillages and broken glassware should be disposed off according to procedures laid down by the pharmacy Broken and damaged products s h o u l d b e p l a c e d i n a segregated area to be returned to the supplier

vi) Inspection Senior staff should inspect all pharmacy areas regularly The shelves and drawers should b e c h e c k e d d a i l y f o r signs of pests and dust Ceiling and walls should be checked for dirt and cobwebs Stock should be checked on a regular basis for deterioration due to climatic conditions

43 Product recalls Products found to be defective should be quickly recalled (withdrawn from the market) The instructions are generally issued either by the manufacturer or the regulatory agency The level of recall is determined by both the degree of risk and the extent of distribution of the product and in India is mainly directed at the distribution chain

On receiving the details of the defective substandard spurious batchbatches of a medicine to be recalled from the manufacturer or the stockist or the FDA the pharmacy should immediately check if the particular b a t c h i s i n s t o c k a n d i f s o s u s p e n d i t s s a l e immediately

Similarly if the regulatory authority in the country bans a particular medicine or FDC the pharmacy should immediately check and remove all the different brands of that particular medicine under consideration

The details of medicines and their batches to be recalled should be available in the q u a r a n t i n e a r e a w h e r e stocks are received and checked This is to ensure that such medicines do not come into the pharmacy

middot The pharmacy should develop SOPs for recall of medicines middot The pharmacy staff should be immediately informed about such medicines and

the details should be displayed in writing in a prominent place in the pharmacy middot Rapid action helps avoid unnecessary exposure to such medicines once the

problem has been d e t e c t e d middot The progress of the recall procedure in the pharmacy should be monitored every

few days to ensure complete compliance middot All stocks of the recalled products should be stored separately from the saleable

stock These can be stored in the expiry cupboard segregated from the expired goods and be appropriately labeled ldquoRecal l e d G o o d s - Not for Salerdquo

The supplier should be notified and asked to replace defective products middot All the details of the procedures followed should be duly recorded in a Recall

Register maintained specially for the purpose The register should include d etails such as -middot Date of the recall middot Nam e of the product

57

bullbull

middot Details of the product (name of manufacturer batch number expiry date) middot Nu m b er of units purchased sold a n d sto c k in ha nd middot Reason for recall middot Nam e of the supplier to whom produc ts w e r e returned along with the date and quantity middot Name and signature of the designated personnel carrying out the recall procedure and recording details middot Name and signature of the chief pharmacist verifying the recall procedures and recording details 4 4 Returned medicines

Medicines may be returned to the pharmacy by clients due to the following reasons -bull

bullbull Unused medicines bullbull Course not completed bullbull Therapy changed by doctor bullbull Side effects experienced by patient bull

bullbull DamagedDefective medicines bullbull Missing or defaced label bullbull Missing tablets in a stripblister bullbull Leakage in bottles bullbull Leakage in strips bull

bullbull Expired medicines

Appropriate SOPs should be framed and followed for their acceptancerefusal and disposal middot bull For unused medicines returned by clients the p harmacy personnel should verify

that these were purchased from their pharmacy They should then be checked for integrity of the packing the dosage form and the expiry date and verified with the client whether they were stored in appropriate conditions This again is at the discretion of each pharmacy

middot The damageddefective medicines returned to the pharmacy should be taken back and stored separately Existing stock of the same product should be checked for similar defects

middot Expired medicines should be accepted from clients at the discretion of the pharmacist and be immediately shifted to the expired goods cupboard These can be stored segregated from the pharmacys own expired goods and be appropriately labelled ldquoExpired Goods returned by clients- Not For Salerdquo

It is advisable not to accept returned medicines requiring cold chain storage (refrigeration) because it cannot be ensured that the cold chain was maintained when the medicines were in the hands of the patientclient middot Appropriate adjustments in t he stocks should be made for medicines

returnedexchanged to update the inventory middot The medicines should then be returned to the respective shelves middot A lsquoReturned Goodsrsquo register needs to be maintained to record all details of returned

medicines

R egister should include such details as-

58

middot N a m e o f t h e p a t i e n t middot Nam e of the product and quantity r e tu r n e d middot Product details such as the batch number and expiry date middot Condition in which received middot Reason for returning products middot Compensatory measures taken wi t h r e s p e c t t o c l i e n t middot Action taken with respect to product middot Name and signature of the personnel accepting the returned medicines and recording details middot Name and signature of the chief pharmacist verifying the recorded details

What the pharmacist would have learnt from this module The storage of medicines is a critical factor in the distribution cycle bullbull Stocks received by the pharmacy should be quarantined in a separate area and necessary checks s h o u ld be performed to ascertain the qua lity a nd quantity of stocks received bullbull Whatever pattern and means of storage used the products should be stored so as to maintain their potency and integrity bullbull Storage conditions should be monitored and maintained on a regular basis bullbull Optimum stock levels should be maintained and regularly monitored for expiry bullbull The design of storage areas should facilitate appropriate storage of medicines bullbull Cleanliness should be maintained in the pharmacy bullbull Adequate measures should be taken in case of returned medicines and recalled products

Optimum storage of medicines is mandatory whether at the distribution stage at the pharmacy or ultimately within the homes of patients The pharmacist has an important r o l e t o p l a y i n t h e s t o r a g e o f m e d i c i n e s i n m a i n t a i n i n g d r u g p o t ency and efficacy and thus facilitating optimum therapeutic benefits Good Pharmacy Practice - IPA -CDSCO - WHO Appendix I Quality Assurance Templates of letters for use if found not of Standard Quality [Frozen and expired goods ]

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated To Name of the Supplier with address

Sub Not of Standard Quality GoMP-Supply of Drugs and medicines-(Codename) Return of Stocks to the Suppliers-reg(New drug policy 2009) Previous letterinvoice ref Sl No Drug Code Drug name

Manufacturing date Expiry date

Supplier address

B a t c h n o

The above items of PO nodated was drawn by the Drug Inspector (Place) on (______________date) as a statutory sampling and declared ldquoNot of Standard

59

Qualityrdquo on -(______________date) by the Government Analyst for the following reasons

- ldquoThe product sample do not confirm to IP specification for (Drug codename with respect to the content of drugrdquo

- ldquoThe product has already been blacklisted by TNMSC on -(______________date) for the failure of (quantity) of batches of drug codenamerdquo

As per the clause of the te nde r d oc um e nt ldquo I f the sa mple s d o not c onf o r m to statutory standardsthe tenderer will be liable for relevant action under the existing laws and the entire stock in such batch should be taken back by the tenderer within a period of 30 days o f t h e r e c e i p t o f t h e l e t t e r f r o m t h e v e n u e

The stock shall be taken back at the expenses of the tendererthe Procurement Authority have the right to destroy such Not of Standard Quality if the tenderer does not take back the goods within the stipulated time

The Procuring Authority will arrange to destroy the Not of Standard Quality drugs within 90 days after the expiry of 30 days mentioned above without further notice and shall also collect demurrage charges calculated at the rate of 2 per week on the value of the drugs rejected till such destructionrdquo

Hence we regret to inform you that you will have to take back the stocks available of the abovesaid batch at your own cost from the drug stores where you have supplied the above batch

Kindly acknowledge the receipt of this reference at once

P r o c u r e m e n t A u t h o r i t y Seal and Stamp

Copy to Ref No dated

1 ) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated13082010

To

Sub Frozen Drugs-ordered to return to the Suppliers-reg(New drug policy 2009) Previous letterinvoice ref

The following products which were earlier frozen have now been ordered to return to suppliers directly with permission from the State drug Authority In this regard the suppliers have been instructed to take back their failed batch from the drug store of the stores Hence you are now instructed to return the following failed batches to the suppliers by obtaining proper authorization letter and acknowledgements from them

60

Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

Kindly acknowledge the receipt of this reference at once

Procurement Authority Seal and Stamp

Copy to

Ref No dated 2) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated14092010

To

Sub Frozen Drugs-ordered to return to the Suppliers- for issue of gate pass after verification reg(New drug policy 2009) Previous letterinvoice ref

The following products which were earlier frozen have now been released Hence they may be issued Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

Kindly acknowledge the receipt of this reference at once

Procurement Authority Seal and Stamp

Copy to

61

Ref No dated 3) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated

To

Sub Stop instruction-reg(New drug policy 2009) Previous letterinvoice ref

Until further instructions stop issue all the batches of the following item Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

You must intimate the available stock in the stores of the said batch Number to the Procurement Authority immediately Also retrieve quantity if already issued

Procurement Authority Seal and Stamp

Copy to

Ref No dated 4) HOD Procurement Office of

62

Appendix II Material handling in drug stores

Rack approx rates and dimensions

S No

Item Description UOM Approx Rate

1 MEDIUM DUTY RACK SIZE 2900 H X 3090 W X 800 D IN MM (AS PER SPECIFICATION)

Each 2499800

2 MEDIUM DUTY RACK ADD ON UNIT FOR SIZE OF SR NO2

Each 2243100

To locate a Box no 3 Rack no 14 in row3

SAMPLE OF RACK no Bin numbering -------------- S a y R K 1 4 R o w 3 B o x 1 6

SAMPLE LAYOUT of RACKS in a Drug Stores

63

Sample of another warehouse of distribution warehouse system

64

65

Slotted Angle racks with bin cards

66

Plastic Pallets

Plastic pallets ar e l i g h t w e i g h t l o w- c ost and exceed industry standards for strength and durability

NOTE A pallet has bottom deckboards (see sketch) A skid does not have bottom

67

deckboards

Battery Operated Stacker

Electric Stacker Ehh (Manual Push Type) - Manual drive - Lifting electrically with Battery 12 V 88 Ah - For loading and un-loading of trucks - Battery and loading device built - in - Battery charge gauge and charging current gauge Simple and Easy Operation - Lifting and Lowering electrically direct on steering arm - Pulling and pushing through steering arm - Electrically operated relief valve on hydraulic aggregate Safe Operation - Emergency Off Switch - Constant lowering speed - Protection through lowering brake valve - Overload protection through overload brake valve - Load chains covered preventing pinching threat - Electrically interlocking during loading process - Secured battery compartment opens upwardly - Stable buffering of the steering arm in upright position - In accordance with EWG Guidelines 89 240 - In accordance with VBG 12b Prevention of Accidents

Pallet Truck [ Top ]

68

----------------------------------------------------------------------------------------------------------------------------

For Transport Of All Goods On Pallets Safe and Easy Operation - through single hand operation Lifting moving

lowering with steering handle - neutral position of the hydraulic possible - overload pressure relief valve Long Service Life - robust co n s t r u c t i o n

- special hardened axles - hardened chromium plated ram - maintenance free Easy Maneuverability - through rubber steering rollers - nylon fork rollers

A h a n d t r o l l e y

69

Trolley with plastic bins for several items del ivery

70

Digital Weighing balances

Balances amp Scales EF Seriers Precision Electronic Balance

71

1

Ice lined Refrigerators

600 litres refrigrator

72

Walk in cooler

vacuum cleaner

73

bullbull

bullbull

12 Checks to be carried out on new stock

Unpacking and checking stock

Supplies received should be unpacked and checked in the quarantine area Staff doing the checks should be adequatel y trained in what they have to check when stock arrives

Checking should be seen not simply as counting the units received but as a part of the quality assurance system bullThis should include middot Visually inspecting the packaging middot Checking the integrity of containers middot V erifying the completeness and leg ibility of la b e ls ( a ppr o ve d dr u g name strength any special storage instructions and expiry date)

bull

The expiry dat e should be checked to ensure that there is adequate shelf life remaining

Supplies should be individually checked using a checklist 35

Checklists

36

The wholesaler supplying the product should be notified immediately in case of any discrepancies ( and the details should be recorded in a register) and sent in a written format to the supplier It should include middot Missing boxes or cartons middot O p en tampered boxes or cartons middot Missing supplies middot Differences in the actual quantity and the quantity shown on the packing middot Additional medicines that had not been ordered but have been supplied middot D a m a g e d b r o k e n o r p oor quality medicines middot Any other discrepancies

The purchase invoices are an important aspect to be considered The invoiced documents should be signed and filed for reference as per the Drugs and Cosmetics Act and retained for at least 3years

If the wholesaler supplies medicines as an emergency without a bill or against a delivery challan

middot The supplies should be checked for integrity and inspected for damage middot The details of supplies received should be recorded middot The supplier should be asked t o send the bill as early as possible middot When the bill is received it should be checked against the details recorded and anomalies if any should be reported to the supplier

To keep a track of the received stock maintaining a S t o c k R e c o r d C a r d c a n b e very useful The entries in the stock record card can be made while checking the stock received STOCK BIN in the stores should have Stock record card

Maintaining a stock card for every product may not be very practical for a retail pharmacy however it could be maintained for costly medicines Nowadays it is much more practical and easier to maintain records using computers

The pharmacist should ensure that medicines manufacturedmarketed by a company are received only through an authorized distribution network of that company This is important to prevent spurious and counterfeit drugs from entering the pharmacy

37

2 STORAGE 21 The need for proper storage The storage of medicines and other products is an important requirement of Good Pharmacy Pr actice Appropriate storage of medicines is essential -

middot bullTo ensure that the potency is maintained middot bullTo prevent deteriorationspoilagedegradation middot bullTo ensuremaintain physical integrity

To ascertain that the quality and safety is maintained throughout their shelf life Storage requirements need to be considered on 2 aspects

a) Integrity of medicines Medicines should be stored in such a way so as to maintain their integrity and potency middot Maintain the right temperature required middot Protect from excessive humidity middot Keep medicines away from direct sunlight middot Protect from pests and rodents

b) Physical location middot Should be easy to locate middot Accessible middot Orderlysystematically placed

2 2 D i f f e r e n t p a t t e r n s o f s t o r a g e The pharmacist could follow any of the different patterns of storage The pattern of stora ge should be selected in such a way that it facilitates speedy and efficient dispensing of medicines

The pattern of storage could vary with each pharmacy experience usual practiceroutine of staff and the person-in charge and also depending on space av ailable turnover etc (i) The medicines could be stored c o m p a n y w i s e ie the medicines manufactured by one company should be grouped together and kept in one place Within each company shelfshelves the medicines may be placed in alphabetical order for easy and quick placement and removal Also bottles tubes boxes etc may be segregated within that shelf

38

(ii) The medicines may also be stored in a lphabe t ic al o r de r ie they are placed in order from left to right based on their name The first letter of the name is used to g r o u p t h e m e d i c i n e s t o g e t h e r a n d k e e p t h e m i n o n e l o c a t i o n I n s o m e p h a r m a c i e s a l l t h e strip packing are placed in drawers or boxes in alphabetical order each box or drawer containing strips of one particular alphabet This system ensures that the strips always remain e n c l o s e d i n t h e b o x e s d r a w e r s a n d a r e n o t e x p o s e d t o d u s t T h e d i s a d v a n t a g e i s that it might lead to mix -u p o f strips in the same drawer and it may cause a problem incase of similar looking strips in which case a wrong medicine may be dispensed Secondly cut strips lying around in the drawer may lose their identity if the batch n u m b e r andor expiry date is not seen on the cut portion of the strip

39

(iii) The medicines may be stored according to their therapeutic class ( e g a n t i b i o t i c s anti asthmatics or anti hypertensives) ie the medicines are kept together based on their pharmacological or therapeutic action

(iv) The medicines may be stockedsegregated according to dosage forms eg l i q u i d s (bottles) solid oral dosage forms eye drops rotacaps ointments etc all stored on separate shelves

Always Remember I Storage of prescription medicines should preferably be separate from OTC medicines OTC medicines especially those that a r e a d v e r t i s e d m a y b e d i s p l a y e d f o r c l i e n t s t o select or to ask questions about [OTC-O v e r t h e c o u n t e r ] II Storage according to temperatures is a must no matter which pattern of storage is followed Also within a particular storage area segregated storage may be maintained In a refrigerator for example medicines may be stored in trays racks and the freezer according to the temperature required

40

Whatever pattern of storage is selected all the personnel should ensure that middot The stocks are stored in an orderly manner middot The medicines are kept back in the same place from where they were removed middot All medicines are arranged neatly once in a while

middot The personnel should be careful while storing the medicines middot They should not throw the medicines haphazardly 23 Different means of storage

middot Within each temperature and security zone medicines must be stored so that they are easily accessible and protected against damage

middot Basic means of storage include shelves racks and drawers middot To prevent dust from entering the shelvesracks it is ideal to have glass

shutterssliding glass doors This can however be disadvantageous because accessibilityspeed is hampered in removing a product from the shelf because the glassshuttersliding glass has to be

41

opened m o v e d e v e r y t i m e a p r o d u c t h a s t o b e p i c k e d u p U s e o f a i r c o n d i t i o n e r s f o r t h e p h arm acy with a closed door at the e n t r a n c e o r a n a i r c u r t a i n c a n r e d u c e t h e d u s t problem In such cases the shelvesracks may be left o p e n

bull

middot Direct storage of cartons on the floor should be avoided because besides being an unhealthy practice the contents may also be damaged by moisture bull

middot Store medicines preferably in shelves with glass shutters for visibility middot Closed shelves further prevent dust from going in especially in India where most

pharmacies are located along busy roads middot Some medicines have to be refrigerated or stored in a cool or cold place Having a

refrigerator or two (as per the need of the pharmacy) is essential to store suc h medicines at temperatures mentioned on the label bull

42

Refrigeration middot All cold chain equipment should meet required standards middot Improvement in refrigeration technology has provided frost -free refrigerators

Pharmacists should opt for frost-free refrigerators as they are easy to maintain and protect printed packaging materials Conventional refrigerators may cause water falling from trays below the freezer on medicines stored in the refrigerator thus causing soggy labels

middot bull Frost-free refrigerators also provide separate and large compartments for the freezer portion (required for storing medicines needing sub-z e r o t e m p e r a t u r e ) and the main storage area with separate doors so that opening one door does not disturb the storage temperature in the other compartment

Care should be taken to keep the refrigerator on 24 hours a day It should not be switched off after working hours It is advisable to have an inverter connected to the refrigerator so that the refrigerator re mains working even when there is a power outage

middot The refrigerator door should be closed tightly middot The refrigerator door should not be left open for too long middot Space should be left between medicines stored in a refrigerator to allow air to

circulate middot The ref rigerator should be placed about an arms length away from the wall

This will increase air circulation thus not affecting the cooling within the refrigerator

middot Vaccines should not be stored on refrigerator door shelves as they are exposed to warmer temperatures each time the door is opened Vaccines should always be stored on the middle shelves of the refrigerator

middot Refrigerated medicines should not be left out of the refrigerator for more than a few minutes

43

middot Consumable products like juices energy drinks e t c s h o u l d n o t b e s t o r e d a l o n g with medicines in refrigerators If required they may be kept in a separate refrigerator

middot An adequate number of refrigerators should be planned to store the entire stocks requiring refrigerated storage

middot Adequate procedures should be followed for defrosting cleaning and maintenance of refrigerators

middot Icefreeze packs should be kept in the freezer compartment so that they can be used for transporting cold temperature medicines The packs can be given to clients along with the medicines requiring cold temperature storage so that the temperature is maintained till the client reaches home and can then put the medicines in a refrigerator) Freezer packs can also be used to keep medicines temporarily in case there is a power outage or refrigerator breakdown

Activity

Prepare a SOP (Standard operating procedure chart) for cleaning a refrigerator Discuss it with your staff finalize its maintenance once a month through AMC -A n n u a l Maintenance contract CMC - Comprehensive maintenance contract and put it up on the pharmacy refrigerator Put the Purchase Order details name of manufacturer Phone of Service Engineer and a register to login the Machine service and down timeService reports may be maintained properly

Refrigerator monitoring and maintenance

middot bullIt is important to carry out routine monitoring and maintenance of the refrigerators and to organize an effective repair system

middot bullThe temperature in the refrigerator must be monitored and recorded routinely at least once a day

middot Any breakdown must be reco rded including the period during which the medicines were exposed to uncontrolled temperatures Medicines may then be kept or discarded depending on the problem guidelines or the manufacturers advice

middot Cold chain monitor cards and devices in or on packages that change color or otherwise alert staff to potential damage assist in monitoring (These are likely to be introduced in India soon)

middot It is essential to have a contingency plan in place before a refrigerator breaks down An arrangement can be made to move the contents to a private refrigerator elsewhere in the community or to obtain a regular supply of ice packs until the defect is rectified

Put filled water bottles in the bottom half of the refrigerator door in order to provide cooling in the refri g e r a t o r w h e n t h e r e i s a p o w e r o u t a g e T h i s m i g h t t a k e c a r e o f t h e temperature when there is no current for a couple of hours If the power outage is expected to last for several hours special arrangements such as an inverter UPS have to be made to keep the refrigerator constantly running in the absence of electricity middot Defrost the refrigerator in case of excessive ice formation and preferably at regular

intervals Keep a record of the same

44

2 4 T e m p e r a t u r e c l i m a t i c c o n d i t i o n s

i) Temperature control middot The medicines in a pharmacy need to be stored at appropriate temperatures to

maintain their stability middot An air-conditioned environment where temperature can be controlled is

recommended for pharmacies Air conditioning offers the option of setting the t e m p e rature as per requirements

middot bullIt is ideal to have an air conditioner to maintain the temperature below 25 C as most medicines require storage below this temperature Secondly this temperature is pleasing to both the staff and the visiting customers too

middot In the absence of an air conditioner circulating fans may be used middot This need is felt even more in certain parts of India where temperatures soar above 45

C and some areas where it falls to sub zero temperatures In such cases temperature maintenance is essential to prevent deterioration of medicines due to unnecessary exposure to drastic temperature fluctuations

middot This need is felt even more in certain parts of India where temperatures soar above 45 C and some areas where it falls to sub zero temperat u r e s I n s u c h c a s e s temperature maintenance is essential to prevent deterioration of medicines due to unnecessary exposure to drastic temperature fluctuations

i i ) Humidity or moisture control Moisture or humidity can adversely affect the stability of me dicines such as tablets capsules powders

45

Gelatin capsules become soft and swell on absorption of moisture The drug content of tablets may undergo surface hydrolysis The presence of moisture may encourage the growth of microbes It is therefore essential to control humidity

To reduce the effect of humidity the following suggestions may be followed -middot Open the windows to allow air circulation Use a fan to circulate fresh (outside) air middot In humid climate a dehumidifier is useful for preventing mo i s t u r e d a m a g e ( i n t h e absence of an air conditioner) middot For bulk containers of tabletscapsules do not keep the container open for a long time and replace the lid or closure immediately after taking out the required number of medicines for dispensing middot Do not allow the medicines to touch the floor or the walls The walls may be damp and may cause moisture absorption damaging the product

middot Calibrated thermometers and manometers can be used to detect temperature and humidity in the pharmacy

middot Periodici t y of checking the temperature should be fixed middot The climatic conditions should be recorded and documented middot Temperature charts should be available for ready reference

Documentation is one of the core activities for achieving and maintaining quality It is one of the most essential components of validation Temperatures in various areas

46

including refrigerators should be recorded at a predetermined periodicity usually daily at the hottest time of the day and such documents should be preserved i i i ) Storage conditions A number of storage conditions are mentioned on the labels of medicinal products These conditions have to be properly interpreted and appropriately complied with

According to the Drugs and Cosmetics Rules 1945

1 The term cool place means a place having a temperature between 10 C and 25 C

2 The term cold place means a place having a temperature not exceeding 8 C In case of storage conditions for specific products please refer to Schedule P The Drugs and Cosmetic Rules 1 9 4 5

The Indian Pharmacopoeia specifies the following storage conditions -

Wherever the condition for storage is not specified medicines may be stored under normal temperature In a country like India however where normal temperatures soar to h i gh temperatures it is recommended that medicines be stored in a cool place

Activity Prepare a list of the storage requirements mentioned on the label of about 20 products in your pharmacy and check if the temperature is maintained

47

25 Special Storage o f s u p p l i e s If the product has no special instructions normal storage conditions apply This means storage in dry clean w e l l -ventilated premises at temperatures of +15 C to +25 C or depending on the climate up to +30 C (WHO1990) Storage instructions are product specific Different brands of the same generic drug may have different storage requirements as they may have different packaging or formulations It is essential to follow the product manufacturers storage instructions to the maximum extent possible Less stable medicines must be stored in specific conditions to maintain their quality or potency

The following products require special storage facilities

middot Products that must be kept frozen (usually vaccines and sera) middot Products sensitive to h eat an d r e q uir in g r e f r ig e r a tio n ( +2 C to +8 C) middot Products that have reduced shelf life at uncontrolled room temperature and need

mechanical ventilation or air conditioning middot Flammable products that require separate fireproof premises middot Products prone to theft o r m i s u s e

Products needing storage in a controlled environment -

The usable shelf life of the following products may be reduced if stored at uncontrolled humidity or at room temperature in hot climates -

middot Some injectables (eg adrenaline) Most injectable preparations are less stable than solid oral forms (tablets and capsules) Injectable preparations in solution are particularly unstable Many injections must be protected from light as well as heat

middot Intravenous fluids (particularly if packed in p lastic containers) middot Some suppositories pessaries creams and ointments These products may melt at

temperatures greater than 30 C Once this happens it is not advisable to use them because the active ingredient in the formula may get unevenly distributed

middot Products containing rubber latex cellulose or some plastics Condoms most sterile disposable medical devices and surgical products such as syringes needles and catheters require protection from excessive humidity and strong light and heat Any o f these conditions may make products brittle stained amp unusable Sterility cannot be assumed if packaging is damaged

In hot climates these products should be stored in the coolest place possible preferably with air conditioning or air circulation fans

48

Products needing freezing or refrigeration-middot Vaccines blood products and many other medicines lose potency if kept even for a

brief period at temperatures outside the recommended range For these products the cold chain must be maintained at every stage of the distribution system

middot Freezing is as damaging as high temperatures for some products including injectable contraceptives ergometrine insulin adrenaline and the DPT DT TT and Hepatitis B vaccines Such products therefore sho uld not be allowed to freeze (not be kept in the freezer compartment)

middot Short periods at room temperature (during transportation or local distribution for instance) may be acceptable for many products (such as ergometrine a n d i n s u l i n ) e v e n t h o u g h s u c h e x posure can to some extent reduce shelf life Other items such as vaccines should always be transported in cold boxes

Storage of insulin injections-

middot Insulin should always be stored in a refrigerator at the recommended temperature of 2 -8 C

middot Insulin should not be kept in the freezer compartment of the refrigerator middot Insulin should ideally be stored horizontally middot It should not be exposed to sunlight or excessive heat middot Insulin suspensions should not be used if the suspension cannot be properly

resuspended due to cake or clump formationbull

Controlled drugs -Narcotics (for example Pethidine injection morphine preparations) and other specified drugs that may be abused are governed by special legislation and regulations The following security measures are suggested in the pharmacy -middot A safe or reinforced double locked cabinet fitted with a light (preferably with a red

bulb) that comes on when the door is opened

49

middot A special register recording details of each receipt or issue with 2 signatures physi cal counting of medicines after each entry and signatures at handover takeover

middot Independent audit (by supervisors and drug inspectors)

Products prone to theft abuse or misuse -

Some medicinesproducts are particularly prone to theft abuse or misuse These include expensive medicines (eg insulin) certain antibiotics and products prone to abuse or misuse like psychotropics etc

Such medicinesproducts should be stored adequately They require stricter record keeping and more frequent stock taki ng than others Periodic audits should be carried out to check for consumption against actual recorded use (registers prescription records stock records etc) to expose any theft or misuse bull26 Storage and stability of medicines Medicines are not stab le indefinitely They are stable for a specific period of time sometimes for a brief period Poor storage conditions accelerate the drug degradation (decomposition) Temperature light and moisture are the most important contributing factors for drug instability It is important to identify and be aware of the potential for instability There is a need to comply with storage requirements to ensure quality medicines for patients It is also important to offer advice to patients too about appropriate storage o f medicines at home The dispensing label should state the storage condition required and be backed up by a verbal reminder especially where special storage is required bull

50

In case stability and storage problems are seen with formulations they should be reported immediately to the representative of the manufacturer and taken out of circulation till the stability problems have been resolved

The pharmacist can easily detect stability problems when products show change in appearance color odor settling of the product contents breaking of emulsions melting of creams oozing of contents from the containers and any such physical changes

3 STOCK CONTROL AND EXPIRY MONITORING 3 1 S t o c k C o n t r o l For economic reasons pharmacists do not like to have stock on their shelves for long periods of time The aim should always be to keep stock at a level that will just meet demand Normally most manufactured medicines have a long shelf life Even then it is essential that there is efficient stock rot ation so that the older stock is used first It is also a good practice to check the expiry date as an integral part of the dispensing process When short shelf life products are involved stock levels may have to be modified to prevent medicines regularl y expiring on the shelves

32 Stock rotation and expiry monitoring In order to avoid accumulation of expired and obsolete stock medicines should be stored and issued according to the following guidelines -middot The stock control system must record the ex p i r y d a t e a n d t h e d a t e o f r e c e i p t middot Stock must be stored so that earliest expiring batches are picked and issued first middot The First In First Out (FIFO) system - In this system the stock which is received

first is sold first This system however may not be useful for pharmacies because most of the stocks carry an expiry date For pharmacies the FEFO system is more practical

51

middot The First Expiry First Out (FEFO) system - In this system the stock having an earlier expiry is sold first The stock with longer shelf life should be placed farthest to the back (or at the bottom in case o f sta c k e d b oxe s) T h is is pa r tic u la r ly impor ta n t with products that have short shelf lives such as vaccines some vitamins antibiotics etc and reduces losses due to expiry

middot E x p i r y dates should be noted on the stock record upon receipt Stock nearing expiry should not be accepted unless it can be used before expiry

Computerization and expiry monitoring In the pharmacy computerization facilitates both checking stocks and expiry mo nitoring and helps-bullbullKeeping a check on products nearing expiry bullbullKeeping a check on non- moving and slow moving products bullbullTo facilitate the removal of medicines nearing expiry from shelves in time to send them back to the wholesaler or supplier

Periodic checking for expiry The expiry date for medicinal products is a critical aspect in pharmaceutical dispensing and due importance should be given to it Periodic checking for expiry of medicines will ensure that the patient will never receive products that have crossed their expiry date During periodical checking of expiry the personnel involved should remove medicines that are nearing expiry bullbullIn -house threshold periods should be set and followed for retrieval of such medicines from the shelves bullbullSuch medicines should be stored separately These should either be dispensed immediately (thus ensuring that they are used before the expiry date) o r t h e y s h o u l d b e returned to the suppliers bullbullA separate area should be designated (cupboard or shelf)marked[FROZEN ZONE] which is adequately marked EXPIRED GOODS- NOT FOR SALE to store all expired stocks FROZEN ZONE

52

Remember Expired medicines are a NATIONAL WASTE So stock only what you can sell Avoid expiries save precious medicines for the nation

Treatment and disposing of expired medicines bullbullProcedures need to be in place for the treatment of expired medicines bullbullThe expired medicines need to be collected and be sent back to the supplier or company for appropriate disposal bullbullRecords must be maintained for expired medicines and how they are disposed off bullbullIn case of medicines that are not returnable to suppliers procedures for disposal need to be followed by the pharmacy in conjunction with the FDA The following procedure can be followed if medicines cannot be returned to suppliers ( T h e b a s i c p h i l o s o p h y of appropriate disposal is to prevent their re- circulation and use) bullbullC u t t h e c o n t ainer in such a manner that the label is also cut In case of tablets and c a p s u l e s d e s t r o y them by disposing them in a bucket of water bullbullUse landfill procedures (deep burial into the ground as per stipulations of Medical Waste Disposal Act prevalent in the respective state) bullbullPour the liquids into the sink and wash away with sufficient quantity of water bullbullKeep a record of such disposal with full details of medicines destroyed Although these measures are usually adopted care has to be taken with such tr e a t m e n t a s studies have shown that flushing of medicines has resulted in tracessmall quantities of medicines being found in waterways and groundwater having potential health and environmental effects

4 O T H E R A S P E C T S 41 Design of storage areas The following important factors need to be considered in design of storage areas -middot The retail outlets in hot areas in summers should be air-conditioned Similarly in

a r e a s o f e x t r e m e c o l d t h e p r e m i s e s w o u l d r e q u i r e w a r m i n g e s p e c i a l l y i n w i n t e r s t o maintain cool temperatures The placement of air -conditioners and heating devices should be such that medicines are not directly exposed to the cold or heat

middot Due consideration should be given to storage requirements of formulations while designing shelves and cupboards in retail outlets Sufficient shelf height should be provided so that all liquid products can be stored vertically As far as possible the shelves should be covered with glass panels to protect medicines from dust and p r e v e n t r a p i d f l u c t u a t i o n s i n temperature

middot Medicines should be stored according to the storage instructions on the labels bullIt is ideal to have a door at the pharmacy entrance to prevent dust from coming in as well as reduceprevent cooled air from going out This may not however be considered feasiblepracticable by many pharmacy owners for fear that clients may not enter the pharmacy because the door may act as a barrier An air curtain is a good alternative to a door

middot There should be minimal direct sunlight falling on the products Particular consideration should be given to premises directly facing the sun

middot bullThe arrangement of lighting in the interior of the premises should also be in a manner that the lights are not focused on the products It has been shown that light causes not only chemical damage but also can catalyze physical changes like moisture uptak e by the products Care should be taken to ensure that only diffused light falls on them

53

middot As far as possible provision should be made for a temperature and humidity indicator device in a pharmacy These devices are now easily available

middot Stability studies o f m e d i c i n e s p a c k e d i n b l i s t e r s h a v e r e v e a l e d t h a t i f t h e s e a r e exposed to light they tend to absorb moisture It is therefore necessary to store them in suitable cartons so that the blisters are not exposed to light Pharmacists should do this even if the manufacturer has not provided cartons

middot Light and temperature sensitive products should not be stored on counters where the light is intense or direct and there is no protection from temperature and humidity

42 Cleaning and maintenance i) Cleaning of storage areas

The storage areas of the pharmacy should be cleaned periodically and cleanliness should be maintained at all times The Standard Operating Procedure for cleaning should be designed and followed accordingly Schedules for cleanups should be laid down and adequate cleaning equipment should be made available

Tips for maintaining cleanliness middot Provide clean pieces of cloth for wiping at various locations in the pharmacy

Replace with clean cloth at regular intervals middot Keep separate pieces of cloth for floors shelves and medicines middot Use a disinfectant andor soap solution to clean floors middot Ensure removal of dust and prevent accumulation of dirt middot Ensure removal of cobwebs middot Use a vacuum cleaner for cleaning areas not easily reachable middot T a k e c a r e t h at breakages are handled and cleared effectively middot Observe the factors leading to waste generation in the pharmacy and take appropriate

measures to tackle the problem middot Record all cleaning procedures performed and maintain all the documents required

For ex a m p l e -bullbullThe floor of the pharmacy may be swept with a broom and swabbed with soap water every morning bullbullThe floor may be swabbed with a disinfectant every week bullbullThe entire premises including shelves and cupboards may be cleaned with a cloth (to remove dust and to check for medicines approaching expiry date or expired medicines) every three months bullbullAll the steps followed should be r e c o r d e d

The floor shelves drawers have to be cleaned and a check should be kept on dust cobwebs spillages due to breakage etc It is therefore essential to have SOPs for cleaning laying down cleaning frequencies allotting responsibilities and maintaining a daily record in the logbook to document all these activities

54

While cleaning dust settled on dosage forms like bottles tubes etc should be removed Before dispensing the products should also be wiped to remove any dust settled during storage

For refrigerators bullbullDefrosting and cleaning should be done at regular intervals bullbullSwitch off the refrigerator while cleaning bullbullCleaning should be done quickly and stocks put back immediately

i i ) Pest control Pests are a serious problem in India where insects reptiles and rodents (eg cockroaches l i z a r d s r a t s s i l v e r f i s h (Deemak - in Hindi ) etc) may find access to the pharmacy storage areas Insects like ants and borer ants may often attack wood in the pharmacy causing d am ag e to shelves cupboardsPest c ontr o l in a p h a r m a c y c a n b e a d i f f i c u l t t a s k b u t t o avoid possible contamination and physical damage to stock it is necessary to keep pests out of the pharmacy premisesPest control measures should be implemented with proper p r e c a u t i o n s t a k i n g u t m o s t c a r e t o a v o i d contamination of medicines

55

Th e following pest control measures c a n be ta ke n f r om tim e to tim e -bullbullRat bait and traps can be placed at various locations bullbullInsecticutors can be used on a permanent basis bullbullInsecticidal sprays and repellants can be used from time to time

i i i ) Fire precautions

Combustible trash such as cartons boxes and other packing waste must not be allowed to accumulate in the store Waste should be deposited in appropriate waste bins and be d i s p o s e d o f f o n a d a i l y b a s i s

F i re detection and fire fighting equipment must be maintained and regularly inspected The pharmacy personnel should receive adequate training in fire fighting techniques and emergency actionFire prevention measures should include a prominently displayed ldquoNoSmokingrdquo sign careful handling and disposal of combustible waste materials and checking of electrical connections at regular intervals

iv) Security middot Doors shutters of the pharmacy should be strong and be fitted with secure locks middot Counters should be designed so that unauthorized personnelclients do not have

access to areas where prescription medicines are stored Access to such areas should be restricted to the pharmacy staff

middot All the pharmacy staff handling supplies should be accountable for their ac t i o n s

56

middot bullSpecial care must be taken in case of Schedule X and manufactured drugs (under NDPS Act) Such medicines should be kept under lock and key and the key should be kept with the Chief Pharmacist or i n h i s a b s e n c e t h e s e n i o r p h a r m a c i s t

v) Breakagespillage and damaged product Products that have been damagedspoiled during storage and handling spillages and broken glassware should be disposed off according to procedures laid down by the pharmacy Broken and damaged products s h o u l d b e p l a c e d i n a segregated area to be returned to the supplier

vi) Inspection Senior staff should inspect all pharmacy areas regularly The shelves and drawers should b e c h e c k e d d a i l y f o r signs of pests and dust Ceiling and walls should be checked for dirt and cobwebs Stock should be checked on a regular basis for deterioration due to climatic conditions

43 Product recalls Products found to be defective should be quickly recalled (withdrawn from the market) The instructions are generally issued either by the manufacturer or the regulatory agency The level of recall is determined by both the degree of risk and the extent of distribution of the product and in India is mainly directed at the distribution chain

On receiving the details of the defective substandard spurious batchbatches of a medicine to be recalled from the manufacturer or the stockist or the FDA the pharmacy should immediately check if the particular b a t c h i s i n s t o c k a n d i f s o s u s p e n d i t s s a l e immediately

Similarly if the regulatory authority in the country bans a particular medicine or FDC the pharmacy should immediately check and remove all the different brands of that particular medicine under consideration

The details of medicines and their batches to be recalled should be available in the q u a r a n t i n e a r e a w h e r e stocks are received and checked This is to ensure that such medicines do not come into the pharmacy

middot The pharmacy should develop SOPs for recall of medicines middot The pharmacy staff should be immediately informed about such medicines and

the details should be displayed in writing in a prominent place in the pharmacy middot Rapid action helps avoid unnecessary exposure to such medicines once the

problem has been d e t e c t e d middot The progress of the recall procedure in the pharmacy should be monitored every

few days to ensure complete compliance middot All stocks of the recalled products should be stored separately from the saleable

stock These can be stored in the expiry cupboard segregated from the expired goods and be appropriately labeled ldquoRecal l e d G o o d s - Not for Salerdquo

The supplier should be notified and asked to replace defective products middot All the details of the procedures followed should be duly recorded in a Recall

Register maintained specially for the purpose The register should include d etails such as -middot Date of the recall middot Nam e of the product

57

bullbull

middot Details of the product (name of manufacturer batch number expiry date) middot Nu m b er of units purchased sold a n d sto c k in ha nd middot Reason for recall middot Nam e of the supplier to whom produc ts w e r e returned along with the date and quantity middot Name and signature of the designated personnel carrying out the recall procedure and recording details middot Name and signature of the chief pharmacist verifying the recall procedures and recording details 4 4 Returned medicines

Medicines may be returned to the pharmacy by clients due to the following reasons -bull

bullbull Unused medicines bullbull Course not completed bullbull Therapy changed by doctor bullbull Side effects experienced by patient bull

bullbull DamagedDefective medicines bullbull Missing or defaced label bullbull Missing tablets in a stripblister bullbull Leakage in bottles bullbull Leakage in strips bull

bullbull Expired medicines

Appropriate SOPs should be framed and followed for their acceptancerefusal and disposal middot bull For unused medicines returned by clients the p harmacy personnel should verify

that these were purchased from their pharmacy They should then be checked for integrity of the packing the dosage form and the expiry date and verified with the client whether they were stored in appropriate conditions This again is at the discretion of each pharmacy

middot The damageddefective medicines returned to the pharmacy should be taken back and stored separately Existing stock of the same product should be checked for similar defects

middot Expired medicines should be accepted from clients at the discretion of the pharmacist and be immediately shifted to the expired goods cupboard These can be stored segregated from the pharmacys own expired goods and be appropriately labelled ldquoExpired Goods returned by clients- Not For Salerdquo

It is advisable not to accept returned medicines requiring cold chain storage (refrigeration) because it cannot be ensured that the cold chain was maintained when the medicines were in the hands of the patientclient middot Appropriate adjustments in t he stocks should be made for medicines

returnedexchanged to update the inventory middot The medicines should then be returned to the respective shelves middot A lsquoReturned Goodsrsquo register needs to be maintained to record all details of returned

medicines

R egister should include such details as-

58

middot N a m e o f t h e p a t i e n t middot Nam e of the product and quantity r e tu r n e d middot Product details such as the batch number and expiry date middot Condition in which received middot Reason for returning products middot Compensatory measures taken wi t h r e s p e c t t o c l i e n t middot Action taken with respect to product middot Name and signature of the personnel accepting the returned medicines and recording details middot Name and signature of the chief pharmacist verifying the recorded details

What the pharmacist would have learnt from this module The storage of medicines is a critical factor in the distribution cycle bullbull Stocks received by the pharmacy should be quarantined in a separate area and necessary checks s h o u ld be performed to ascertain the qua lity a nd quantity of stocks received bullbull Whatever pattern and means of storage used the products should be stored so as to maintain their potency and integrity bullbull Storage conditions should be monitored and maintained on a regular basis bullbull Optimum stock levels should be maintained and regularly monitored for expiry bullbull The design of storage areas should facilitate appropriate storage of medicines bullbull Cleanliness should be maintained in the pharmacy bullbull Adequate measures should be taken in case of returned medicines and recalled products

Optimum storage of medicines is mandatory whether at the distribution stage at the pharmacy or ultimately within the homes of patients The pharmacist has an important r o l e t o p l a y i n t h e s t o r a g e o f m e d i c i n e s i n m a i n t a i n i n g d r u g p o t ency and efficacy and thus facilitating optimum therapeutic benefits Good Pharmacy Practice - IPA -CDSCO - WHO Appendix I Quality Assurance Templates of letters for use if found not of Standard Quality [Frozen and expired goods ]

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated To Name of the Supplier with address

Sub Not of Standard Quality GoMP-Supply of Drugs and medicines-(Codename) Return of Stocks to the Suppliers-reg(New drug policy 2009) Previous letterinvoice ref Sl No Drug Code Drug name

Manufacturing date Expiry date

Supplier address

B a t c h n o

The above items of PO nodated was drawn by the Drug Inspector (Place) on (______________date) as a statutory sampling and declared ldquoNot of Standard

59

Qualityrdquo on -(______________date) by the Government Analyst for the following reasons

- ldquoThe product sample do not confirm to IP specification for (Drug codename with respect to the content of drugrdquo

- ldquoThe product has already been blacklisted by TNMSC on -(______________date) for the failure of (quantity) of batches of drug codenamerdquo

As per the clause of the te nde r d oc um e nt ldquo I f the sa mple s d o not c onf o r m to statutory standardsthe tenderer will be liable for relevant action under the existing laws and the entire stock in such batch should be taken back by the tenderer within a period of 30 days o f t h e r e c e i p t o f t h e l e t t e r f r o m t h e v e n u e

The stock shall be taken back at the expenses of the tendererthe Procurement Authority have the right to destroy such Not of Standard Quality if the tenderer does not take back the goods within the stipulated time

The Procuring Authority will arrange to destroy the Not of Standard Quality drugs within 90 days after the expiry of 30 days mentioned above without further notice and shall also collect demurrage charges calculated at the rate of 2 per week on the value of the drugs rejected till such destructionrdquo

Hence we regret to inform you that you will have to take back the stocks available of the abovesaid batch at your own cost from the drug stores where you have supplied the above batch

Kindly acknowledge the receipt of this reference at once

P r o c u r e m e n t A u t h o r i t y Seal and Stamp

Copy to Ref No dated

1 ) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated13082010

To

Sub Frozen Drugs-ordered to return to the Suppliers-reg(New drug policy 2009) Previous letterinvoice ref

The following products which were earlier frozen have now been ordered to return to suppliers directly with permission from the State drug Authority In this regard the suppliers have been instructed to take back their failed batch from the drug store of the stores Hence you are now instructed to return the following failed batches to the suppliers by obtaining proper authorization letter and acknowledgements from them

60

Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

Kindly acknowledge the receipt of this reference at once

Procurement Authority Seal and Stamp

Copy to

Ref No dated 2) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated14092010

To

Sub Frozen Drugs-ordered to return to the Suppliers- for issue of gate pass after verification reg(New drug policy 2009) Previous letterinvoice ref

The following products which were earlier frozen have now been released Hence they may be issued Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

Kindly acknowledge the receipt of this reference at once

Procurement Authority Seal and Stamp

Copy to

61

Ref No dated 3) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated

To

Sub Stop instruction-reg(New drug policy 2009) Previous letterinvoice ref

Until further instructions stop issue all the batches of the following item Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

You must intimate the available stock in the stores of the said batch Number to the Procurement Authority immediately Also retrieve quantity if already issued

Procurement Authority Seal and Stamp

Copy to

Ref No dated 4) HOD Procurement Office of

62

Appendix II Material handling in drug stores

Rack approx rates and dimensions

S No

Item Description UOM Approx Rate

1 MEDIUM DUTY RACK SIZE 2900 H X 3090 W X 800 D IN MM (AS PER SPECIFICATION)

Each 2499800

2 MEDIUM DUTY RACK ADD ON UNIT FOR SIZE OF SR NO2

Each 2243100

To locate a Box no 3 Rack no 14 in row3

SAMPLE OF RACK no Bin numbering -------------- S a y R K 1 4 R o w 3 B o x 1 6

SAMPLE LAYOUT of RACKS in a Drug Stores

63

Sample of another warehouse of distribution warehouse system

64

65

Slotted Angle racks with bin cards

66

Plastic Pallets

Plastic pallets ar e l i g h t w e i g h t l o w- c ost and exceed industry standards for strength and durability

NOTE A pallet has bottom deckboards (see sketch) A skid does not have bottom

67

deckboards

Battery Operated Stacker

Electric Stacker Ehh (Manual Push Type) - Manual drive - Lifting electrically with Battery 12 V 88 Ah - For loading and un-loading of trucks - Battery and loading device built - in - Battery charge gauge and charging current gauge Simple and Easy Operation - Lifting and Lowering electrically direct on steering arm - Pulling and pushing through steering arm - Electrically operated relief valve on hydraulic aggregate Safe Operation - Emergency Off Switch - Constant lowering speed - Protection through lowering brake valve - Overload protection through overload brake valve - Load chains covered preventing pinching threat - Electrically interlocking during loading process - Secured battery compartment opens upwardly - Stable buffering of the steering arm in upright position - In accordance with EWG Guidelines 89 240 - In accordance with VBG 12b Prevention of Accidents

Pallet Truck [ Top ]

68

----------------------------------------------------------------------------------------------------------------------------

For Transport Of All Goods On Pallets Safe and Easy Operation - through single hand operation Lifting moving

lowering with steering handle - neutral position of the hydraulic possible - overload pressure relief valve Long Service Life - robust co n s t r u c t i o n

- special hardened axles - hardened chromium plated ram - maintenance free Easy Maneuverability - through rubber steering rollers - nylon fork rollers

A h a n d t r o l l e y

69

Trolley with plastic bins for several items del ivery

70

Digital Weighing balances

Balances amp Scales EF Seriers Precision Electronic Balance

71

1

Ice lined Refrigerators

600 litres refrigrator

72

Walk in cooler

vacuum cleaner

73

Checklists

36

The wholesaler supplying the product should be notified immediately in case of any discrepancies ( and the details should be recorded in a register) and sent in a written format to the supplier It should include middot Missing boxes or cartons middot O p en tampered boxes or cartons middot Missing supplies middot Differences in the actual quantity and the quantity shown on the packing middot Additional medicines that had not been ordered but have been supplied middot D a m a g e d b r o k e n o r p oor quality medicines middot Any other discrepancies

The purchase invoices are an important aspect to be considered The invoiced documents should be signed and filed for reference as per the Drugs and Cosmetics Act and retained for at least 3years

If the wholesaler supplies medicines as an emergency without a bill or against a delivery challan

middot The supplies should be checked for integrity and inspected for damage middot The details of supplies received should be recorded middot The supplier should be asked t o send the bill as early as possible middot When the bill is received it should be checked against the details recorded and anomalies if any should be reported to the supplier

To keep a track of the received stock maintaining a S t o c k R e c o r d C a r d c a n b e very useful The entries in the stock record card can be made while checking the stock received STOCK BIN in the stores should have Stock record card

Maintaining a stock card for every product may not be very practical for a retail pharmacy however it could be maintained for costly medicines Nowadays it is much more practical and easier to maintain records using computers

The pharmacist should ensure that medicines manufacturedmarketed by a company are received only through an authorized distribution network of that company This is important to prevent spurious and counterfeit drugs from entering the pharmacy

37

2 STORAGE 21 The need for proper storage The storage of medicines and other products is an important requirement of Good Pharmacy Pr actice Appropriate storage of medicines is essential -

middot bullTo ensure that the potency is maintained middot bullTo prevent deteriorationspoilagedegradation middot bullTo ensuremaintain physical integrity

To ascertain that the quality and safety is maintained throughout their shelf life Storage requirements need to be considered on 2 aspects

a) Integrity of medicines Medicines should be stored in such a way so as to maintain their integrity and potency middot Maintain the right temperature required middot Protect from excessive humidity middot Keep medicines away from direct sunlight middot Protect from pests and rodents

b) Physical location middot Should be easy to locate middot Accessible middot Orderlysystematically placed

2 2 D i f f e r e n t p a t t e r n s o f s t o r a g e The pharmacist could follow any of the different patterns of storage The pattern of stora ge should be selected in such a way that it facilitates speedy and efficient dispensing of medicines

The pattern of storage could vary with each pharmacy experience usual practiceroutine of staff and the person-in charge and also depending on space av ailable turnover etc (i) The medicines could be stored c o m p a n y w i s e ie the medicines manufactured by one company should be grouped together and kept in one place Within each company shelfshelves the medicines may be placed in alphabetical order for easy and quick placement and removal Also bottles tubes boxes etc may be segregated within that shelf

38

(ii) The medicines may also be stored in a lphabe t ic al o r de r ie they are placed in order from left to right based on their name The first letter of the name is used to g r o u p t h e m e d i c i n e s t o g e t h e r a n d k e e p t h e m i n o n e l o c a t i o n I n s o m e p h a r m a c i e s a l l t h e strip packing are placed in drawers or boxes in alphabetical order each box or drawer containing strips of one particular alphabet This system ensures that the strips always remain e n c l o s e d i n t h e b o x e s d r a w e r s a n d a r e n o t e x p o s e d t o d u s t T h e d i s a d v a n t a g e i s that it might lead to mix -u p o f strips in the same drawer and it may cause a problem incase of similar looking strips in which case a wrong medicine may be dispensed Secondly cut strips lying around in the drawer may lose their identity if the batch n u m b e r andor expiry date is not seen on the cut portion of the strip

39

(iii) The medicines may be stored according to their therapeutic class ( e g a n t i b i o t i c s anti asthmatics or anti hypertensives) ie the medicines are kept together based on their pharmacological or therapeutic action

(iv) The medicines may be stockedsegregated according to dosage forms eg l i q u i d s (bottles) solid oral dosage forms eye drops rotacaps ointments etc all stored on separate shelves

Always Remember I Storage of prescription medicines should preferably be separate from OTC medicines OTC medicines especially those that a r e a d v e r t i s e d m a y b e d i s p l a y e d f o r c l i e n t s t o select or to ask questions about [OTC-O v e r t h e c o u n t e r ] II Storage according to temperatures is a must no matter which pattern of storage is followed Also within a particular storage area segregated storage may be maintained In a refrigerator for example medicines may be stored in trays racks and the freezer according to the temperature required

40

Whatever pattern of storage is selected all the personnel should ensure that middot The stocks are stored in an orderly manner middot The medicines are kept back in the same place from where they were removed middot All medicines are arranged neatly once in a while

middot The personnel should be careful while storing the medicines middot They should not throw the medicines haphazardly 23 Different means of storage

middot Within each temperature and security zone medicines must be stored so that they are easily accessible and protected against damage

middot Basic means of storage include shelves racks and drawers middot To prevent dust from entering the shelvesracks it is ideal to have glass

shutterssliding glass doors This can however be disadvantageous because accessibilityspeed is hampered in removing a product from the shelf because the glassshuttersliding glass has to be

41

opened m o v e d e v e r y t i m e a p r o d u c t h a s t o b e p i c k e d u p U s e o f a i r c o n d i t i o n e r s f o r t h e p h arm acy with a closed door at the e n t r a n c e o r a n a i r c u r t a i n c a n r e d u c e t h e d u s t problem In such cases the shelvesracks may be left o p e n

bull

middot Direct storage of cartons on the floor should be avoided because besides being an unhealthy practice the contents may also be damaged by moisture bull

middot Store medicines preferably in shelves with glass shutters for visibility middot Closed shelves further prevent dust from going in especially in India where most

pharmacies are located along busy roads middot Some medicines have to be refrigerated or stored in a cool or cold place Having a

refrigerator or two (as per the need of the pharmacy) is essential to store suc h medicines at temperatures mentioned on the label bull

42

Refrigeration middot All cold chain equipment should meet required standards middot Improvement in refrigeration technology has provided frost -free refrigerators

Pharmacists should opt for frost-free refrigerators as they are easy to maintain and protect printed packaging materials Conventional refrigerators may cause water falling from trays below the freezer on medicines stored in the refrigerator thus causing soggy labels

middot bull Frost-free refrigerators also provide separate and large compartments for the freezer portion (required for storing medicines needing sub-z e r o t e m p e r a t u r e ) and the main storage area with separate doors so that opening one door does not disturb the storage temperature in the other compartment

Care should be taken to keep the refrigerator on 24 hours a day It should not be switched off after working hours It is advisable to have an inverter connected to the refrigerator so that the refrigerator re mains working even when there is a power outage

middot The refrigerator door should be closed tightly middot The refrigerator door should not be left open for too long middot Space should be left between medicines stored in a refrigerator to allow air to

circulate middot The ref rigerator should be placed about an arms length away from the wall

This will increase air circulation thus not affecting the cooling within the refrigerator

middot Vaccines should not be stored on refrigerator door shelves as they are exposed to warmer temperatures each time the door is opened Vaccines should always be stored on the middle shelves of the refrigerator

middot Refrigerated medicines should not be left out of the refrigerator for more than a few minutes

43

middot Consumable products like juices energy drinks e t c s h o u l d n o t b e s t o r e d a l o n g with medicines in refrigerators If required they may be kept in a separate refrigerator

middot An adequate number of refrigerators should be planned to store the entire stocks requiring refrigerated storage

middot Adequate procedures should be followed for defrosting cleaning and maintenance of refrigerators

middot Icefreeze packs should be kept in the freezer compartment so that they can be used for transporting cold temperature medicines The packs can be given to clients along with the medicines requiring cold temperature storage so that the temperature is maintained till the client reaches home and can then put the medicines in a refrigerator) Freezer packs can also be used to keep medicines temporarily in case there is a power outage or refrigerator breakdown

Activity

Prepare a SOP (Standard operating procedure chart) for cleaning a refrigerator Discuss it with your staff finalize its maintenance once a month through AMC -A n n u a l Maintenance contract CMC - Comprehensive maintenance contract and put it up on the pharmacy refrigerator Put the Purchase Order details name of manufacturer Phone of Service Engineer and a register to login the Machine service and down timeService reports may be maintained properly

Refrigerator monitoring and maintenance

middot bullIt is important to carry out routine monitoring and maintenance of the refrigerators and to organize an effective repair system

middot bullThe temperature in the refrigerator must be monitored and recorded routinely at least once a day

middot Any breakdown must be reco rded including the period during which the medicines were exposed to uncontrolled temperatures Medicines may then be kept or discarded depending on the problem guidelines or the manufacturers advice

middot Cold chain monitor cards and devices in or on packages that change color or otherwise alert staff to potential damage assist in monitoring (These are likely to be introduced in India soon)

middot It is essential to have a contingency plan in place before a refrigerator breaks down An arrangement can be made to move the contents to a private refrigerator elsewhere in the community or to obtain a regular supply of ice packs until the defect is rectified

Put filled water bottles in the bottom half of the refrigerator door in order to provide cooling in the refri g e r a t o r w h e n t h e r e i s a p o w e r o u t a g e T h i s m i g h t t a k e c a r e o f t h e temperature when there is no current for a couple of hours If the power outage is expected to last for several hours special arrangements such as an inverter UPS have to be made to keep the refrigerator constantly running in the absence of electricity middot Defrost the refrigerator in case of excessive ice formation and preferably at regular

intervals Keep a record of the same

44

2 4 T e m p e r a t u r e c l i m a t i c c o n d i t i o n s

i) Temperature control middot The medicines in a pharmacy need to be stored at appropriate temperatures to

maintain their stability middot An air-conditioned environment where temperature can be controlled is

recommended for pharmacies Air conditioning offers the option of setting the t e m p e rature as per requirements

middot bullIt is ideal to have an air conditioner to maintain the temperature below 25 C as most medicines require storage below this temperature Secondly this temperature is pleasing to both the staff and the visiting customers too

middot In the absence of an air conditioner circulating fans may be used middot This need is felt even more in certain parts of India where temperatures soar above 45

C and some areas where it falls to sub zero temperatures In such cases temperature maintenance is essential to prevent deterioration of medicines due to unnecessary exposure to drastic temperature fluctuations

middot This need is felt even more in certain parts of India where temperatures soar above 45 C and some areas where it falls to sub zero temperat u r e s I n s u c h c a s e s temperature maintenance is essential to prevent deterioration of medicines due to unnecessary exposure to drastic temperature fluctuations

i i ) Humidity or moisture control Moisture or humidity can adversely affect the stability of me dicines such as tablets capsules powders

45

Gelatin capsules become soft and swell on absorption of moisture The drug content of tablets may undergo surface hydrolysis The presence of moisture may encourage the growth of microbes It is therefore essential to control humidity

To reduce the effect of humidity the following suggestions may be followed -middot Open the windows to allow air circulation Use a fan to circulate fresh (outside) air middot In humid climate a dehumidifier is useful for preventing mo i s t u r e d a m a g e ( i n t h e absence of an air conditioner) middot For bulk containers of tabletscapsules do not keep the container open for a long time and replace the lid or closure immediately after taking out the required number of medicines for dispensing middot Do not allow the medicines to touch the floor or the walls The walls may be damp and may cause moisture absorption damaging the product

middot Calibrated thermometers and manometers can be used to detect temperature and humidity in the pharmacy

middot Periodici t y of checking the temperature should be fixed middot The climatic conditions should be recorded and documented middot Temperature charts should be available for ready reference

Documentation is one of the core activities for achieving and maintaining quality It is one of the most essential components of validation Temperatures in various areas

46

including refrigerators should be recorded at a predetermined periodicity usually daily at the hottest time of the day and such documents should be preserved i i i ) Storage conditions A number of storage conditions are mentioned on the labels of medicinal products These conditions have to be properly interpreted and appropriately complied with

According to the Drugs and Cosmetics Rules 1945

1 The term cool place means a place having a temperature between 10 C and 25 C

2 The term cold place means a place having a temperature not exceeding 8 C In case of storage conditions for specific products please refer to Schedule P The Drugs and Cosmetic Rules 1 9 4 5

The Indian Pharmacopoeia specifies the following storage conditions -

Wherever the condition for storage is not specified medicines may be stored under normal temperature In a country like India however where normal temperatures soar to h i gh temperatures it is recommended that medicines be stored in a cool place

Activity Prepare a list of the storage requirements mentioned on the label of about 20 products in your pharmacy and check if the temperature is maintained

47

25 Special Storage o f s u p p l i e s If the product has no special instructions normal storage conditions apply This means storage in dry clean w e l l -ventilated premises at temperatures of +15 C to +25 C or depending on the climate up to +30 C (WHO1990) Storage instructions are product specific Different brands of the same generic drug may have different storage requirements as they may have different packaging or formulations It is essential to follow the product manufacturers storage instructions to the maximum extent possible Less stable medicines must be stored in specific conditions to maintain their quality or potency

The following products require special storage facilities

middot Products that must be kept frozen (usually vaccines and sera) middot Products sensitive to h eat an d r e q uir in g r e f r ig e r a tio n ( +2 C to +8 C) middot Products that have reduced shelf life at uncontrolled room temperature and need

mechanical ventilation or air conditioning middot Flammable products that require separate fireproof premises middot Products prone to theft o r m i s u s e

Products needing storage in a controlled environment -

The usable shelf life of the following products may be reduced if stored at uncontrolled humidity or at room temperature in hot climates -

middot Some injectables (eg adrenaline) Most injectable preparations are less stable than solid oral forms (tablets and capsules) Injectable preparations in solution are particularly unstable Many injections must be protected from light as well as heat

middot Intravenous fluids (particularly if packed in p lastic containers) middot Some suppositories pessaries creams and ointments These products may melt at

temperatures greater than 30 C Once this happens it is not advisable to use them because the active ingredient in the formula may get unevenly distributed

middot Products containing rubber latex cellulose or some plastics Condoms most sterile disposable medical devices and surgical products such as syringes needles and catheters require protection from excessive humidity and strong light and heat Any o f these conditions may make products brittle stained amp unusable Sterility cannot be assumed if packaging is damaged

In hot climates these products should be stored in the coolest place possible preferably with air conditioning or air circulation fans

48

Products needing freezing or refrigeration-middot Vaccines blood products and many other medicines lose potency if kept even for a

brief period at temperatures outside the recommended range For these products the cold chain must be maintained at every stage of the distribution system

middot Freezing is as damaging as high temperatures for some products including injectable contraceptives ergometrine insulin adrenaline and the DPT DT TT and Hepatitis B vaccines Such products therefore sho uld not be allowed to freeze (not be kept in the freezer compartment)

middot Short periods at room temperature (during transportation or local distribution for instance) may be acceptable for many products (such as ergometrine a n d i n s u l i n ) e v e n t h o u g h s u c h e x posure can to some extent reduce shelf life Other items such as vaccines should always be transported in cold boxes

Storage of insulin injections-

middot Insulin should always be stored in a refrigerator at the recommended temperature of 2 -8 C

middot Insulin should not be kept in the freezer compartment of the refrigerator middot Insulin should ideally be stored horizontally middot It should not be exposed to sunlight or excessive heat middot Insulin suspensions should not be used if the suspension cannot be properly

resuspended due to cake or clump formationbull

Controlled drugs -Narcotics (for example Pethidine injection morphine preparations) and other specified drugs that may be abused are governed by special legislation and regulations The following security measures are suggested in the pharmacy -middot A safe or reinforced double locked cabinet fitted with a light (preferably with a red

bulb) that comes on when the door is opened

49

middot A special register recording details of each receipt or issue with 2 signatures physi cal counting of medicines after each entry and signatures at handover takeover

middot Independent audit (by supervisors and drug inspectors)

Products prone to theft abuse or misuse -

Some medicinesproducts are particularly prone to theft abuse or misuse These include expensive medicines (eg insulin) certain antibiotics and products prone to abuse or misuse like psychotropics etc

Such medicinesproducts should be stored adequately They require stricter record keeping and more frequent stock taki ng than others Periodic audits should be carried out to check for consumption against actual recorded use (registers prescription records stock records etc) to expose any theft or misuse bull26 Storage and stability of medicines Medicines are not stab le indefinitely They are stable for a specific period of time sometimes for a brief period Poor storage conditions accelerate the drug degradation (decomposition) Temperature light and moisture are the most important contributing factors for drug instability It is important to identify and be aware of the potential for instability There is a need to comply with storage requirements to ensure quality medicines for patients It is also important to offer advice to patients too about appropriate storage o f medicines at home The dispensing label should state the storage condition required and be backed up by a verbal reminder especially where special storage is required bull

50

In case stability and storage problems are seen with formulations they should be reported immediately to the representative of the manufacturer and taken out of circulation till the stability problems have been resolved

The pharmacist can easily detect stability problems when products show change in appearance color odor settling of the product contents breaking of emulsions melting of creams oozing of contents from the containers and any such physical changes

3 STOCK CONTROL AND EXPIRY MONITORING 3 1 S t o c k C o n t r o l For economic reasons pharmacists do not like to have stock on their shelves for long periods of time The aim should always be to keep stock at a level that will just meet demand Normally most manufactured medicines have a long shelf life Even then it is essential that there is efficient stock rot ation so that the older stock is used first It is also a good practice to check the expiry date as an integral part of the dispensing process When short shelf life products are involved stock levels may have to be modified to prevent medicines regularl y expiring on the shelves

32 Stock rotation and expiry monitoring In order to avoid accumulation of expired and obsolete stock medicines should be stored and issued according to the following guidelines -middot The stock control system must record the ex p i r y d a t e a n d t h e d a t e o f r e c e i p t middot Stock must be stored so that earliest expiring batches are picked and issued first middot The First In First Out (FIFO) system - In this system the stock which is received

first is sold first This system however may not be useful for pharmacies because most of the stocks carry an expiry date For pharmacies the FEFO system is more practical

51

middot The First Expiry First Out (FEFO) system - In this system the stock having an earlier expiry is sold first The stock with longer shelf life should be placed farthest to the back (or at the bottom in case o f sta c k e d b oxe s) T h is is pa r tic u la r ly impor ta n t with products that have short shelf lives such as vaccines some vitamins antibiotics etc and reduces losses due to expiry

middot E x p i r y dates should be noted on the stock record upon receipt Stock nearing expiry should not be accepted unless it can be used before expiry

Computerization and expiry monitoring In the pharmacy computerization facilitates both checking stocks and expiry mo nitoring and helps-bullbullKeeping a check on products nearing expiry bullbullKeeping a check on non- moving and slow moving products bullbullTo facilitate the removal of medicines nearing expiry from shelves in time to send them back to the wholesaler or supplier

Periodic checking for expiry The expiry date for medicinal products is a critical aspect in pharmaceutical dispensing and due importance should be given to it Periodic checking for expiry of medicines will ensure that the patient will never receive products that have crossed their expiry date During periodical checking of expiry the personnel involved should remove medicines that are nearing expiry bullbullIn -house threshold periods should be set and followed for retrieval of such medicines from the shelves bullbullSuch medicines should be stored separately These should either be dispensed immediately (thus ensuring that they are used before the expiry date) o r t h e y s h o u l d b e returned to the suppliers bullbullA separate area should be designated (cupboard or shelf)marked[FROZEN ZONE] which is adequately marked EXPIRED GOODS- NOT FOR SALE to store all expired stocks FROZEN ZONE

52

Remember Expired medicines are a NATIONAL WASTE So stock only what you can sell Avoid expiries save precious medicines for the nation

Treatment and disposing of expired medicines bullbullProcedures need to be in place for the treatment of expired medicines bullbullThe expired medicines need to be collected and be sent back to the supplier or company for appropriate disposal bullbullRecords must be maintained for expired medicines and how they are disposed off bullbullIn case of medicines that are not returnable to suppliers procedures for disposal need to be followed by the pharmacy in conjunction with the FDA The following procedure can be followed if medicines cannot be returned to suppliers ( T h e b a s i c p h i l o s o p h y of appropriate disposal is to prevent their re- circulation and use) bullbullC u t t h e c o n t ainer in such a manner that the label is also cut In case of tablets and c a p s u l e s d e s t r o y them by disposing them in a bucket of water bullbullUse landfill procedures (deep burial into the ground as per stipulations of Medical Waste Disposal Act prevalent in the respective state) bullbullPour the liquids into the sink and wash away with sufficient quantity of water bullbullKeep a record of such disposal with full details of medicines destroyed Although these measures are usually adopted care has to be taken with such tr e a t m e n t a s studies have shown that flushing of medicines has resulted in tracessmall quantities of medicines being found in waterways and groundwater having potential health and environmental effects

4 O T H E R A S P E C T S 41 Design of storage areas The following important factors need to be considered in design of storage areas -middot The retail outlets in hot areas in summers should be air-conditioned Similarly in

a r e a s o f e x t r e m e c o l d t h e p r e m i s e s w o u l d r e q u i r e w a r m i n g e s p e c i a l l y i n w i n t e r s t o maintain cool temperatures The placement of air -conditioners and heating devices should be such that medicines are not directly exposed to the cold or heat

middot Due consideration should be given to storage requirements of formulations while designing shelves and cupboards in retail outlets Sufficient shelf height should be provided so that all liquid products can be stored vertically As far as possible the shelves should be covered with glass panels to protect medicines from dust and p r e v e n t r a p i d f l u c t u a t i o n s i n temperature

middot Medicines should be stored according to the storage instructions on the labels bullIt is ideal to have a door at the pharmacy entrance to prevent dust from coming in as well as reduceprevent cooled air from going out This may not however be considered feasiblepracticable by many pharmacy owners for fear that clients may not enter the pharmacy because the door may act as a barrier An air curtain is a good alternative to a door

middot There should be minimal direct sunlight falling on the products Particular consideration should be given to premises directly facing the sun

middot bullThe arrangement of lighting in the interior of the premises should also be in a manner that the lights are not focused on the products It has been shown that light causes not only chemical damage but also can catalyze physical changes like moisture uptak e by the products Care should be taken to ensure that only diffused light falls on them

53

middot As far as possible provision should be made for a temperature and humidity indicator device in a pharmacy These devices are now easily available

middot Stability studies o f m e d i c i n e s p a c k e d i n b l i s t e r s h a v e r e v e a l e d t h a t i f t h e s e a r e exposed to light they tend to absorb moisture It is therefore necessary to store them in suitable cartons so that the blisters are not exposed to light Pharmacists should do this even if the manufacturer has not provided cartons

middot Light and temperature sensitive products should not be stored on counters where the light is intense or direct and there is no protection from temperature and humidity

42 Cleaning and maintenance i) Cleaning of storage areas

The storage areas of the pharmacy should be cleaned periodically and cleanliness should be maintained at all times The Standard Operating Procedure for cleaning should be designed and followed accordingly Schedules for cleanups should be laid down and adequate cleaning equipment should be made available

Tips for maintaining cleanliness middot Provide clean pieces of cloth for wiping at various locations in the pharmacy

Replace with clean cloth at regular intervals middot Keep separate pieces of cloth for floors shelves and medicines middot Use a disinfectant andor soap solution to clean floors middot Ensure removal of dust and prevent accumulation of dirt middot Ensure removal of cobwebs middot Use a vacuum cleaner for cleaning areas not easily reachable middot T a k e c a r e t h at breakages are handled and cleared effectively middot Observe the factors leading to waste generation in the pharmacy and take appropriate

measures to tackle the problem middot Record all cleaning procedures performed and maintain all the documents required

For ex a m p l e -bullbullThe floor of the pharmacy may be swept with a broom and swabbed with soap water every morning bullbullThe floor may be swabbed with a disinfectant every week bullbullThe entire premises including shelves and cupboards may be cleaned with a cloth (to remove dust and to check for medicines approaching expiry date or expired medicines) every three months bullbullAll the steps followed should be r e c o r d e d

The floor shelves drawers have to be cleaned and a check should be kept on dust cobwebs spillages due to breakage etc It is therefore essential to have SOPs for cleaning laying down cleaning frequencies allotting responsibilities and maintaining a daily record in the logbook to document all these activities

54

While cleaning dust settled on dosage forms like bottles tubes etc should be removed Before dispensing the products should also be wiped to remove any dust settled during storage

For refrigerators bullbullDefrosting and cleaning should be done at regular intervals bullbullSwitch off the refrigerator while cleaning bullbullCleaning should be done quickly and stocks put back immediately

i i ) Pest control Pests are a serious problem in India where insects reptiles and rodents (eg cockroaches l i z a r d s r a t s s i l v e r f i s h (Deemak - in Hindi ) etc) may find access to the pharmacy storage areas Insects like ants and borer ants may often attack wood in the pharmacy causing d am ag e to shelves cupboardsPest c ontr o l in a p h a r m a c y c a n b e a d i f f i c u l t t a s k b u t t o avoid possible contamination and physical damage to stock it is necessary to keep pests out of the pharmacy premisesPest control measures should be implemented with proper p r e c a u t i o n s t a k i n g u t m o s t c a r e t o a v o i d contamination of medicines

55

Th e following pest control measures c a n be ta ke n f r om tim e to tim e -bullbullRat bait and traps can be placed at various locations bullbullInsecticutors can be used on a permanent basis bullbullInsecticidal sprays and repellants can be used from time to time

i i i ) Fire precautions

Combustible trash such as cartons boxes and other packing waste must not be allowed to accumulate in the store Waste should be deposited in appropriate waste bins and be d i s p o s e d o f f o n a d a i l y b a s i s

F i re detection and fire fighting equipment must be maintained and regularly inspected The pharmacy personnel should receive adequate training in fire fighting techniques and emergency actionFire prevention measures should include a prominently displayed ldquoNoSmokingrdquo sign careful handling and disposal of combustible waste materials and checking of electrical connections at regular intervals

iv) Security middot Doors shutters of the pharmacy should be strong and be fitted with secure locks middot Counters should be designed so that unauthorized personnelclients do not have

access to areas where prescription medicines are stored Access to such areas should be restricted to the pharmacy staff

middot All the pharmacy staff handling supplies should be accountable for their ac t i o n s

56

middot bullSpecial care must be taken in case of Schedule X and manufactured drugs (under NDPS Act) Such medicines should be kept under lock and key and the key should be kept with the Chief Pharmacist or i n h i s a b s e n c e t h e s e n i o r p h a r m a c i s t

v) Breakagespillage and damaged product Products that have been damagedspoiled during storage and handling spillages and broken glassware should be disposed off according to procedures laid down by the pharmacy Broken and damaged products s h o u l d b e p l a c e d i n a segregated area to be returned to the supplier

vi) Inspection Senior staff should inspect all pharmacy areas regularly The shelves and drawers should b e c h e c k e d d a i l y f o r signs of pests and dust Ceiling and walls should be checked for dirt and cobwebs Stock should be checked on a regular basis for deterioration due to climatic conditions

43 Product recalls Products found to be defective should be quickly recalled (withdrawn from the market) The instructions are generally issued either by the manufacturer or the regulatory agency The level of recall is determined by both the degree of risk and the extent of distribution of the product and in India is mainly directed at the distribution chain

On receiving the details of the defective substandard spurious batchbatches of a medicine to be recalled from the manufacturer or the stockist or the FDA the pharmacy should immediately check if the particular b a t c h i s i n s t o c k a n d i f s o s u s p e n d i t s s a l e immediately

Similarly if the regulatory authority in the country bans a particular medicine or FDC the pharmacy should immediately check and remove all the different brands of that particular medicine under consideration

The details of medicines and their batches to be recalled should be available in the q u a r a n t i n e a r e a w h e r e stocks are received and checked This is to ensure that such medicines do not come into the pharmacy

middot The pharmacy should develop SOPs for recall of medicines middot The pharmacy staff should be immediately informed about such medicines and

the details should be displayed in writing in a prominent place in the pharmacy middot Rapid action helps avoid unnecessary exposure to such medicines once the

problem has been d e t e c t e d middot The progress of the recall procedure in the pharmacy should be monitored every

few days to ensure complete compliance middot All stocks of the recalled products should be stored separately from the saleable

stock These can be stored in the expiry cupboard segregated from the expired goods and be appropriately labeled ldquoRecal l e d G o o d s - Not for Salerdquo

The supplier should be notified and asked to replace defective products middot All the details of the procedures followed should be duly recorded in a Recall

Register maintained specially for the purpose The register should include d etails such as -middot Date of the recall middot Nam e of the product

57

bullbull

middot Details of the product (name of manufacturer batch number expiry date) middot Nu m b er of units purchased sold a n d sto c k in ha nd middot Reason for recall middot Nam e of the supplier to whom produc ts w e r e returned along with the date and quantity middot Name and signature of the designated personnel carrying out the recall procedure and recording details middot Name and signature of the chief pharmacist verifying the recall procedures and recording details 4 4 Returned medicines

Medicines may be returned to the pharmacy by clients due to the following reasons -bull

bullbull Unused medicines bullbull Course not completed bullbull Therapy changed by doctor bullbull Side effects experienced by patient bull

bullbull DamagedDefective medicines bullbull Missing or defaced label bullbull Missing tablets in a stripblister bullbull Leakage in bottles bullbull Leakage in strips bull

bullbull Expired medicines

Appropriate SOPs should be framed and followed for their acceptancerefusal and disposal middot bull For unused medicines returned by clients the p harmacy personnel should verify

that these were purchased from their pharmacy They should then be checked for integrity of the packing the dosage form and the expiry date and verified with the client whether they were stored in appropriate conditions This again is at the discretion of each pharmacy

middot The damageddefective medicines returned to the pharmacy should be taken back and stored separately Existing stock of the same product should be checked for similar defects

middot Expired medicines should be accepted from clients at the discretion of the pharmacist and be immediately shifted to the expired goods cupboard These can be stored segregated from the pharmacys own expired goods and be appropriately labelled ldquoExpired Goods returned by clients- Not For Salerdquo

It is advisable not to accept returned medicines requiring cold chain storage (refrigeration) because it cannot be ensured that the cold chain was maintained when the medicines were in the hands of the patientclient middot Appropriate adjustments in t he stocks should be made for medicines

returnedexchanged to update the inventory middot The medicines should then be returned to the respective shelves middot A lsquoReturned Goodsrsquo register needs to be maintained to record all details of returned

medicines

R egister should include such details as-

58

middot N a m e o f t h e p a t i e n t middot Nam e of the product and quantity r e tu r n e d middot Product details such as the batch number and expiry date middot Condition in which received middot Reason for returning products middot Compensatory measures taken wi t h r e s p e c t t o c l i e n t middot Action taken with respect to product middot Name and signature of the personnel accepting the returned medicines and recording details middot Name and signature of the chief pharmacist verifying the recorded details

What the pharmacist would have learnt from this module The storage of medicines is a critical factor in the distribution cycle bullbull Stocks received by the pharmacy should be quarantined in a separate area and necessary checks s h o u ld be performed to ascertain the qua lity a nd quantity of stocks received bullbull Whatever pattern and means of storage used the products should be stored so as to maintain their potency and integrity bullbull Storage conditions should be monitored and maintained on a regular basis bullbull Optimum stock levels should be maintained and regularly monitored for expiry bullbull The design of storage areas should facilitate appropriate storage of medicines bullbull Cleanliness should be maintained in the pharmacy bullbull Adequate measures should be taken in case of returned medicines and recalled products

Optimum storage of medicines is mandatory whether at the distribution stage at the pharmacy or ultimately within the homes of patients The pharmacist has an important r o l e t o p l a y i n t h e s t o r a g e o f m e d i c i n e s i n m a i n t a i n i n g d r u g p o t ency and efficacy and thus facilitating optimum therapeutic benefits Good Pharmacy Practice - IPA -CDSCO - WHO Appendix I Quality Assurance Templates of letters for use if found not of Standard Quality [Frozen and expired goods ]

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated To Name of the Supplier with address

Sub Not of Standard Quality GoMP-Supply of Drugs and medicines-(Codename) Return of Stocks to the Suppliers-reg(New drug policy 2009) Previous letterinvoice ref Sl No Drug Code Drug name

Manufacturing date Expiry date

Supplier address

B a t c h n o

The above items of PO nodated was drawn by the Drug Inspector (Place) on (______________date) as a statutory sampling and declared ldquoNot of Standard

59

Qualityrdquo on -(______________date) by the Government Analyst for the following reasons

- ldquoThe product sample do not confirm to IP specification for (Drug codename with respect to the content of drugrdquo

- ldquoThe product has already been blacklisted by TNMSC on -(______________date) for the failure of (quantity) of batches of drug codenamerdquo

As per the clause of the te nde r d oc um e nt ldquo I f the sa mple s d o not c onf o r m to statutory standardsthe tenderer will be liable for relevant action under the existing laws and the entire stock in such batch should be taken back by the tenderer within a period of 30 days o f t h e r e c e i p t o f t h e l e t t e r f r o m t h e v e n u e

The stock shall be taken back at the expenses of the tendererthe Procurement Authority have the right to destroy such Not of Standard Quality if the tenderer does not take back the goods within the stipulated time

The Procuring Authority will arrange to destroy the Not of Standard Quality drugs within 90 days after the expiry of 30 days mentioned above without further notice and shall also collect demurrage charges calculated at the rate of 2 per week on the value of the drugs rejected till such destructionrdquo

Hence we regret to inform you that you will have to take back the stocks available of the abovesaid batch at your own cost from the drug stores where you have supplied the above batch

Kindly acknowledge the receipt of this reference at once

P r o c u r e m e n t A u t h o r i t y Seal and Stamp

Copy to Ref No dated

1 ) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated13082010

To

Sub Frozen Drugs-ordered to return to the Suppliers-reg(New drug policy 2009) Previous letterinvoice ref

The following products which were earlier frozen have now been ordered to return to suppliers directly with permission from the State drug Authority In this regard the suppliers have been instructed to take back their failed batch from the drug store of the stores Hence you are now instructed to return the following failed batches to the suppliers by obtaining proper authorization letter and acknowledgements from them

60

Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

Kindly acknowledge the receipt of this reference at once

Procurement Authority Seal and Stamp

Copy to

Ref No dated 2) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated14092010

To

Sub Frozen Drugs-ordered to return to the Suppliers- for issue of gate pass after verification reg(New drug policy 2009) Previous letterinvoice ref

The following products which were earlier frozen have now been released Hence they may be issued Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

Kindly acknowledge the receipt of this reference at once

Procurement Authority Seal and Stamp

Copy to

61

Ref No dated 3) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated

To

Sub Stop instruction-reg(New drug policy 2009) Previous letterinvoice ref

Until further instructions stop issue all the batches of the following item Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

You must intimate the available stock in the stores of the said batch Number to the Procurement Authority immediately Also retrieve quantity if already issued

Procurement Authority Seal and Stamp

Copy to

Ref No dated 4) HOD Procurement Office of

62

Appendix II Material handling in drug stores

Rack approx rates and dimensions

S No

Item Description UOM Approx Rate

1 MEDIUM DUTY RACK SIZE 2900 H X 3090 W X 800 D IN MM (AS PER SPECIFICATION)

Each 2499800

2 MEDIUM DUTY RACK ADD ON UNIT FOR SIZE OF SR NO2

Each 2243100

To locate a Box no 3 Rack no 14 in row3

SAMPLE OF RACK no Bin numbering -------------- S a y R K 1 4 R o w 3 B o x 1 6

SAMPLE LAYOUT of RACKS in a Drug Stores

63

Sample of another warehouse of distribution warehouse system

64

65

Slotted Angle racks with bin cards

66

Plastic Pallets

Plastic pallets ar e l i g h t w e i g h t l o w- c ost and exceed industry standards for strength and durability

NOTE A pallet has bottom deckboards (see sketch) A skid does not have bottom

67

deckboards

Battery Operated Stacker

Electric Stacker Ehh (Manual Push Type) - Manual drive - Lifting electrically with Battery 12 V 88 Ah - For loading and un-loading of trucks - Battery and loading device built - in - Battery charge gauge and charging current gauge Simple and Easy Operation - Lifting and Lowering electrically direct on steering arm - Pulling and pushing through steering arm - Electrically operated relief valve on hydraulic aggregate Safe Operation - Emergency Off Switch - Constant lowering speed - Protection through lowering brake valve - Overload protection through overload brake valve - Load chains covered preventing pinching threat - Electrically interlocking during loading process - Secured battery compartment opens upwardly - Stable buffering of the steering arm in upright position - In accordance with EWG Guidelines 89 240 - In accordance with VBG 12b Prevention of Accidents

Pallet Truck [ Top ]

68

----------------------------------------------------------------------------------------------------------------------------

For Transport Of All Goods On Pallets Safe and Easy Operation - through single hand operation Lifting moving

lowering with steering handle - neutral position of the hydraulic possible - overload pressure relief valve Long Service Life - robust co n s t r u c t i o n

- special hardened axles - hardened chromium plated ram - maintenance free Easy Maneuverability - through rubber steering rollers - nylon fork rollers

A h a n d t r o l l e y

69

Trolley with plastic bins for several items del ivery

70

Digital Weighing balances

Balances amp Scales EF Seriers Precision Electronic Balance

71

1

Ice lined Refrigerators

600 litres refrigrator

72

Walk in cooler

vacuum cleaner

73

The wholesaler supplying the product should be notified immediately in case of any discrepancies ( and the details should be recorded in a register) and sent in a written format to the supplier It should include middot Missing boxes or cartons middot O p en tampered boxes or cartons middot Missing supplies middot Differences in the actual quantity and the quantity shown on the packing middot Additional medicines that had not been ordered but have been supplied middot D a m a g e d b r o k e n o r p oor quality medicines middot Any other discrepancies

The purchase invoices are an important aspect to be considered The invoiced documents should be signed and filed for reference as per the Drugs and Cosmetics Act and retained for at least 3years

If the wholesaler supplies medicines as an emergency without a bill or against a delivery challan

middot The supplies should be checked for integrity and inspected for damage middot The details of supplies received should be recorded middot The supplier should be asked t o send the bill as early as possible middot When the bill is received it should be checked against the details recorded and anomalies if any should be reported to the supplier

To keep a track of the received stock maintaining a S t o c k R e c o r d C a r d c a n b e very useful The entries in the stock record card can be made while checking the stock received STOCK BIN in the stores should have Stock record card

Maintaining a stock card for every product may not be very practical for a retail pharmacy however it could be maintained for costly medicines Nowadays it is much more practical and easier to maintain records using computers

The pharmacist should ensure that medicines manufacturedmarketed by a company are received only through an authorized distribution network of that company This is important to prevent spurious and counterfeit drugs from entering the pharmacy

37

2 STORAGE 21 The need for proper storage The storage of medicines and other products is an important requirement of Good Pharmacy Pr actice Appropriate storage of medicines is essential -

middot bullTo ensure that the potency is maintained middot bullTo prevent deteriorationspoilagedegradation middot bullTo ensuremaintain physical integrity

To ascertain that the quality and safety is maintained throughout their shelf life Storage requirements need to be considered on 2 aspects

a) Integrity of medicines Medicines should be stored in such a way so as to maintain their integrity and potency middot Maintain the right temperature required middot Protect from excessive humidity middot Keep medicines away from direct sunlight middot Protect from pests and rodents

b) Physical location middot Should be easy to locate middot Accessible middot Orderlysystematically placed

2 2 D i f f e r e n t p a t t e r n s o f s t o r a g e The pharmacist could follow any of the different patterns of storage The pattern of stora ge should be selected in such a way that it facilitates speedy and efficient dispensing of medicines

The pattern of storage could vary with each pharmacy experience usual practiceroutine of staff and the person-in charge and also depending on space av ailable turnover etc (i) The medicines could be stored c o m p a n y w i s e ie the medicines manufactured by one company should be grouped together and kept in one place Within each company shelfshelves the medicines may be placed in alphabetical order for easy and quick placement and removal Also bottles tubes boxes etc may be segregated within that shelf

38

(ii) The medicines may also be stored in a lphabe t ic al o r de r ie they are placed in order from left to right based on their name The first letter of the name is used to g r o u p t h e m e d i c i n e s t o g e t h e r a n d k e e p t h e m i n o n e l o c a t i o n I n s o m e p h a r m a c i e s a l l t h e strip packing are placed in drawers or boxes in alphabetical order each box or drawer containing strips of one particular alphabet This system ensures that the strips always remain e n c l o s e d i n t h e b o x e s d r a w e r s a n d a r e n o t e x p o s e d t o d u s t T h e d i s a d v a n t a g e i s that it might lead to mix -u p o f strips in the same drawer and it may cause a problem incase of similar looking strips in which case a wrong medicine may be dispensed Secondly cut strips lying around in the drawer may lose their identity if the batch n u m b e r andor expiry date is not seen on the cut portion of the strip

39

(iii) The medicines may be stored according to their therapeutic class ( e g a n t i b i o t i c s anti asthmatics or anti hypertensives) ie the medicines are kept together based on their pharmacological or therapeutic action

(iv) The medicines may be stockedsegregated according to dosage forms eg l i q u i d s (bottles) solid oral dosage forms eye drops rotacaps ointments etc all stored on separate shelves

Always Remember I Storage of prescription medicines should preferably be separate from OTC medicines OTC medicines especially those that a r e a d v e r t i s e d m a y b e d i s p l a y e d f o r c l i e n t s t o select or to ask questions about [OTC-O v e r t h e c o u n t e r ] II Storage according to temperatures is a must no matter which pattern of storage is followed Also within a particular storage area segregated storage may be maintained In a refrigerator for example medicines may be stored in trays racks and the freezer according to the temperature required

40

Whatever pattern of storage is selected all the personnel should ensure that middot The stocks are stored in an orderly manner middot The medicines are kept back in the same place from where they were removed middot All medicines are arranged neatly once in a while

middot The personnel should be careful while storing the medicines middot They should not throw the medicines haphazardly 23 Different means of storage

middot Within each temperature and security zone medicines must be stored so that they are easily accessible and protected against damage

middot Basic means of storage include shelves racks and drawers middot To prevent dust from entering the shelvesracks it is ideal to have glass

shutterssliding glass doors This can however be disadvantageous because accessibilityspeed is hampered in removing a product from the shelf because the glassshuttersliding glass has to be

41

opened m o v e d e v e r y t i m e a p r o d u c t h a s t o b e p i c k e d u p U s e o f a i r c o n d i t i o n e r s f o r t h e p h arm acy with a closed door at the e n t r a n c e o r a n a i r c u r t a i n c a n r e d u c e t h e d u s t problem In such cases the shelvesracks may be left o p e n

bull

middot Direct storage of cartons on the floor should be avoided because besides being an unhealthy practice the contents may also be damaged by moisture bull

middot Store medicines preferably in shelves with glass shutters for visibility middot Closed shelves further prevent dust from going in especially in India where most

pharmacies are located along busy roads middot Some medicines have to be refrigerated or stored in a cool or cold place Having a

refrigerator or two (as per the need of the pharmacy) is essential to store suc h medicines at temperatures mentioned on the label bull

42

Refrigeration middot All cold chain equipment should meet required standards middot Improvement in refrigeration technology has provided frost -free refrigerators

Pharmacists should opt for frost-free refrigerators as they are easy to maintain and protect printed packaging materials Conventional refrigerators may cause water falling from trays below the freezer on medicines stored in the refrigerator thus causing soggy labels

middot bull Frost-free refrigerators also provide separate and large compartments for the freezer portion (required for storing medicines needing sub-z e r o t e m p e r a t u r e ) and the main storage area with separate doors so that opening one door does not disturb the storage temperature in the other compartment

Care should be taken to keep the refrigerator on 24 hours a day It should not be switched off after working hours It is advisable to have an inverter connected to the refrigerator so that the refrigerator re mains working even when there is a power outage

middot The refrigerator door should be closed tightly middot The refrigerator door should not be left open for too long middot Space should be left between medicines stored in a refrigerator to allow air to

circulate middot The ref rigerator should be placed about an arms length away from the wall

This will increase air circulation thus not affecting the cooling within the refrigerator

middot Vaccines should not be stored on refrigerator door shelves as they are exposed to warmer temperatures each time the door is opened Vaccines should always be stored on the middle shelves of the refrigerator

middot Refrigerated medicines should not be left out of the refrigerator for more than a few minutes

43

middot Consumable products like juices energy drinks e t c s h o u l d n o t b e s t o r e d a l o n g with medicines in refrigerators If required they may be kept in a separate refrigerator

middot An adequate number of refrigerators should be planned to store the entire stocks requiring refrigerated storage

middot Adequate procedures should be followed for defrosting cleaning and maintenance of refrigerators

middot Icefreeze packs should be kept in the freezer compartment so that they can be used for transporting cold temperature medicines The packs can be given to clients along with the medicines requiring cold temperature storage so that the temperature is maintained till the client reaches home and can then put the medicines in a refrigerator) Freezer packs can also be used to keep medicines temporarily in case there is a power outage or refrigerator breakdown

Activity

Prepare a SOP (Standard operating procedure chart) for cleaning a refrigerator Discuss it with your staff finalize its maintenance once a month through AMC -A n n u a l Maintenance contract CMC - Comprehensive maintenance contract and put it up on the pharmacy refrigerator Put the Purchase Order details name of manufacturer Phone of Service Engineer and a register to login the Machine service and down timeService reports may be maintained properly

Refrigerator monitoring and maintenance

middot bullIt is important to carry out routine monitoring and maintenance of the refrigerators and to organize an effective repair system

middot bullThe temperature in the refrigerator must be monitored and recorded routinely at least once a day

middot Any breakdown must be reco rded including the period during which the medicines were exposed to uncontrolled temperatures Medicines may then be kept or discarded depending on the problem guidelines or the manufacturers advice

middot Cold chain monitor cards and devices in or on packages that change color or otherwise alert staff to potential damage assist in monitoring (These are likely to be introduced in India soon)

middot It is essential to have a contingency plan in place before a refrigerator breaks down An arrangement can be made to move the contents to a private refrigerator elsewhere in the community or to obtain a regular supply of ice packs until the defect is rectified

Put filled water bottles in the bottom half of the refrigerator door in order to provide cooling in the refri g e r a t o r w h e n t h e r e i s a p o w e r o u t a g e T h i s m i g h t t a k e c a r e o f t h e temperature when there is no current for a couple of hours If the power outage is expected to last for several hours special arrangements such as an inverter UPS have to be made to keep the refrigerator constantly running in the absence of electricity middot Defrost the refrigerator in case of excessive ice formation and preferably at regular

intervals Keep a record of the same

44

2 4 T e m p e r a t u r e c l i m a t i c c o n d i t i o n s

i) Temperature control middot The medicines in a pharmacy need to be stored at appropriate temperatures to

maintain their stability middot An air-conditioned environment where temperature can be controlled is

recommended for pharmacies Air conditioning offers the option of setting the t e m p e rature as per requirements

middot bullIt is ideal to have an air conditioner to maintain the temperature below 25 C as most medicines require storage below this temperature Secondly this temperature is pleasing to both the staff and the visiting customers too

middot In the absence of an air conditioner circulating fans may be used middot This need is felt even more in certain parts of India where temperatures soar above 45

C and some areas where it falls to sub zero temperatures In such cases temperature maintenance is essential to prevent deterioration of medicines due to unnecessary exposure to drastic temperature fluctuations

middot This need is felt even more in certain parts of India where temperatures soar above 45 C and some areas where it falls to sub zero temperat u r e s I n s u c h c a s e s temperature maintenance is essential to prevent deterioration of medicines due to unnecessary exposure to drastic temperature fluctuations

i i ) Humidity or moisture control Moisture or humidity can adversely affect the stability of me dicines such as tablets capsules powders

45

Gelatin capsules become soft and swell on absorption of moisture The drug content of tablets may undergo surface hydrolysis The presence of moisture may encourage the growth of microbes It is therefore essential to control humidity

To reduce the effect of humidity the following suggestions may be followed -middot Open the windows to allow air circulation Use a fan to circulate fresh (outside) air middot In humid climate a dehumidifier is useful for preventing mo i s t u r e d a m a g e ( i n t h e absence of an air conditioner) middot For bulk containers of tabletscapsules do not keep the container open for a long time and replace the lid or closure immediately after taking out the required number of medicines for dispensing middot Do not allow the medicines to touch the floor or the walls The walls may be damp and may cause moisture absorption damaging the product

middot Calibrated thermometers and manometers can be used to detect temperature and humidity in the pharmacy

middot Periodici t y of checking the temperature should be fixed middot The climatic conditions should be recorded and documented middot Temperature charts should be available for ready reference

Documentation is one of the core activities for achieving and maintaining quality It is one of the most essential components of validation Temperatures in various areas

46

including refrigerators should be recorded at a predetermined periodicity usually daily at the hottest time of the day and such documents should be preserved i i i ) Storage conditions A number of storage conditions are mentioned on the labels of medicinal products These conditions have to be properly interpreted and appropriately complied with

According to the Drugs and Cosmetics Rules 1945

1 The term cool place means a place having a temperature between 10 C and 25 C

2 The term cold place means a place having a temperature not exceeding 8 C In case of storage conditions for specific products please refer to Schedule P The Drugs and Cosmetic Rules 1 9 4 5

The Indian Pharmacopoeia specifies the following storage conditions -

Wherever the condition for storage is not specified medicines may be stored under normal temperature In a country like India however where normal temperatures soar to h i gh temperatures it is recommended that medicines be stored in a cool place

Activity Prepare a list of the storage requirements mentioned on the label of about 20 products in your pharmacy and check if the temperature is maintained

47

25 Special Storage o f s u p p l i e s If the product has no special instructions normal storage conditions apply This means storage in dry clean w e l l -ventilated premises at temperatures of +15 C to +25 C or depending on the climate up to +30 C (WHO1990) Storage instructions are product specific Different brands of the same generic drug may have different storage requirements as they may have different packaging or formulations It is essential to follow the product manufacturers storage instructions to the maximum extent possible Less stable medicines must be stored in specific conditions to maintain their quality or potency

The following products require special storage facilities

middot Products that must be kept frozen (usually vaccines and sera) middot Products sensitive to h eat an d r e q uir in g r e f r ig e r a tio n ( +2 C to +8 C) middot Products that have reduced shelf life at uncontrolled room temperature and need

mechanical ventilation or air conditioning middot Flammable products that require separate fireproof premises middot Products prone to theft o r m i s u s e

Products needing storage in a controlled environment -

The usable shelf life of the following products may be reduced if stored at uncontrolled humidity or at room temperature in hot climates -

middot Some injectables (eg adrenaline) Most injectable preparations are less stable than solid oral forms (tablets and capsules) Injectable preparations in solution are particularly unstable Many injections must be protected from light as well as heat

middot Intravenous fluids (particularly if packed in p lastic containers) middot Some suppositories pessaries creams and ointments These products may melt at

temperatures greater than 30 C Once this happens it is not advisable to use them because the active ingredient in the formula may get unevenly distributed

middot Products containing rubber latex cellulose or some plastics Condoms most sterile disposable medical devices and surgical products such as syringes needles and catheters require protection from excessive humidity and strong light and heat Any o f these conditions may make products brittle stained amp unusable Sterility cannot be assumed if packaging is damaged

In hot climates these products should be stored in the coolest place possible preferably with air conditioning or air circulation fans

48

Products needing freezing or refrigeration-middot Vaccines blood products and many other medicines lose potency if kept even for a

brief period at temperatures outside the recommended range For these products the cold chain must be maintained at every stage of the distribution system

middot Freezing is as damaging as high temperatures for some products including injectable contraceptives ergometrine insulin adrenaline and the DPT DT TT and Hepatitis B vaccines Such products therefore sho uld not be allowed to freeze (not be kept in the freezer compartment)

middot Short periods at room temperature (during transportation or local distribution for instance) may be acceptable for many products (such as ergometrine a n d i n s u l i n ) e v e n t h o u g h s u c h e x posure can to some extent reduce shelf life Other items such as vaccines should always be transported in cold boxes

Storage of insulin injections-

middot Insulin should always be stored in a refrigerator at the recommended temperature of 2 -8 C

middot Insulin should not be kept in the freezer compartment of the refrigerator middot Insulin should ideally be stored horizontally middot It should not be exposed to sunlight or excessive heat middot Insulin suspensions should not be used if the suspension cannot be properly

resuspended due to cake or clump formationbull

Controlled drugs -Narcotics (for example Pethidine injection morphine preparations) and other specified drugs that may be abused are governed by special legislation and regulations The following security measures are suggested in the pharmacy -middot A safe or reinforced double locked cabinet fitted with a light (preferably with a red

bulb) that comes on when the door is opened

49

middot A special register recording details of each receipt or issue with 2 signatures physi cal counting of medicines after each entry and signatures at handover takeover

middot Independent audit (by supervisors and drug inspectors)

Products prone to theft abuse or misuse -

Some medicinesproducts are particularly prone to theft abuse or misuse These include expensive medicines (eg insulin) certain antibiotics and products prone to abuse or misuse like psychotropics etc

Such medicinesproducts should be stored adequately They require stricter record keeping and more frequent stock taki ng than others Periodic audits should be carried out to check for consumption against actual recorded use (registers prescription records stock records etc) to expose any theft or misuse bull26 Storage and stability of medicines Medicines are not stab le indefinitely They are stable for a specific period of time sometimes for a brief period Poor storage conditions accelerate the drug degradation (decomposition) Temperature light and moisture are the most important contributing factors for drug instability It is important to identify and be aware of the potential for instability There is a need to comply with storage requirements to ensure quality medicines for patients It is also important to offer advice to patients too about appropriate storage o f medicines at home The dispensing label should state the storage condition required and be backed up by a verbal reminder especially where special storage is required bull

50

In case stability and storage problems are seen with formulations they should be reported immediately to the representative of the manufacturer and taken out of circulation till the stability problems have been resolved

The pharmacist can easily detect stability problems when products show change in appearance color odor settling of the product contents breaking of emulsions melting of creams oozing of contents from the containers and any such physical changes

3 STOCK CONTROL AND EXPIRY MONITORING 3 1 S t o c k C o n t r o l For economic reasons pharmacists do not like to have stock on their shelves for long periods of time The aim should always be to keep stock at a level that will just meet demand Normally most manufactured medicines have a long shelf life Even then it is essential that there is efficient stock rot ation so that the older stock is used first It is also a good practice to check the expiry date as an integral part of the dispensing process When short shelf life products are involved stock levels may have to be modified to prevent medicines regularl y expiring on the shelves

32 Stock rotation and expiry monitoring In order to avoid accumulation of expired and obsolete stock medicines should be stored and issued according to the following guidelines -middot The stock control system must record the ex p i r y d a t e a n d t h e d a t e o f r e c e i p t middot Stock must be stored so that earliest expiring batches are picked and issued first middot The First In First Out (FIFO) system - In this system the stock which is received

first is sold first This system however may not be useful for pharmacies because most of the stocks carry an expiry date For pharmacies the FEFO system is more practical

51

middot The First Expiry First Out (FEFO) system - In this system the stock having an earlier expiry is sold first The stock with longer shelf life should be placed farthest to the back (or at the bottom in case o f sta c k e d b oxe s) T h is is pa r tic u la r ly impor ta n t with products that have short shelf lives such as vaccines some vitamins antibiotics etc and reduces losses due to expiry

middot E x p i r y dates should be noted on the stock record upon receipt Stock nearing expiry should not be accepted unless it can be used before expiry

Computerization and expiry monitoring In the pharmacy computerization facilitates both checking stocks and expiry mo nitoring and helps-bullbullKeeping a check on products nearing expiry bullbullKeeping a check on non- moving and slow moving products bullbullTo facilitate the removal of medicines nearing expiry from shelves in time to send them back to the wholesaler or supplier

Periodic checking for expiry The expiry date for medicinal products is a critical aspect in pharmaceutical dispensing and due importance should be given to it Periodic checking for expiry of medicines will ensure that the patient will never receive products that have crossed their expiry date During periodical checking of expiry the personnel involved should remove medicines that are nearing expiry bullbullIn -house threshold periods should be set and followed for retrieval of such medicines from the shelves bullbullSuch medicines should be stored separately These should either be dispensed immediately (thus ensuring that they are used before the expiry date) o r t h e y s h o u l d b e returned to the suppliers bullbullA separate area should be designated (cupboard or shelf)marked[FROZEN ZONE] which is adequately marked EXPIRED GOODS- NOT FOR SALE to store all expired stocks FROZEN ZONE

52

Remember Expired medicines are a NATIONAL WASTE So stock only what you can sell Avoid expiries save precious medicines for the nation

Treatment and disposing of expired medicines bullbullProcedures need to be in place for the treatment of expired medicines bullbullThe expired medicines need to be collected and be sent back to the supplier or company for appropriate disposal bullbullRecords must be maintained for expired medicines and how they are disposed off bullbullIn case of medicines that are not returnable to suppliers procedures for disposal need to be followed by the pharmacy in conjunction with the FDA The following procedure can be followed if medicines cannot be returned to suppliers ( T h e b a s i c p h i l o s o p h y of appropriate disposal is to prevent their re- circulation and use) bullbullC u t t h e c o n t ainer in such a manner that the label is also cut In case of tablets and c a p s u l e s d e s t r o y them by disposing them in a bucket of water bullbullUse landfill procedures (deep burial into the ground as per stipulations of Medical Waste Disposal Act prevalent in the respective state) bullbullPour the liquids into the sink and wash away with sufficient quantity of water bullbullKeep a record of such disposal with full details of medicines destroyed Although these measures are usually adopted care has to be taken with such tr e a t m e n t a s studies have shown that flushing of medicines has resulted in tracessmall quantities of medicines being found in waterways and groundwater having potential health and environmental effects

4 O T H E R A S P E C T S 41 Design of storage areas The following important factors need to be considered in design of storage areas -middot The retail outlets in hot areas in summers should be air-conditioned Similarly in

a r e a s o f e x t r e m e c o l d t h e p r e m i s e s w o u l d r e q u i r e w a r m i n g e s p e c i a l l y i n w i n t e r s t o maintain cool temperatures The placement of air -conditioners and heating devices should be such that medicines are not directly exposed to the cold or heat

middot Due consideration should be given to storage requirements of formulations while designing shelves and cupboards in retail outlets Sufficient shelf height should be provided so that all liquid products can be stored vertically As far as possible the shelves should be covered with glass panels to protect medicines from dust and p r e v e n t r a p i d f l u c t u a t i o n s i n temperature

middot Medicines should be stored according to the storage instructions on the labels bullIt is ideal to have a door at the pharmacy entrance to prevent dust from coming in as well as reduceprevent cooled air from going out This may not however be considered feasiblepracticable by many pharmacy owners for fear that clients may not enter the pharmacy because the door may act as a barrier An air curtain is a good alternative to a door

middot There should be minimal direct sunlight falling on the products Particular consideration should be given to premises directly facing the sun

middot bullThe arrangement of lighting in the interior of the premises should also be in a manner that the lights are not focused on the products It has been shown that light causes not only chemical damage but also can catalyze physical changes like moisture uptak e by the products Care should be taken to ensure that only diffused light falls on them

53

middot As far as possible provision should be made for a temperature and humidity indicator device in a pharmacy These devices are now easily available

middot Stability studies o f m e d i c i n e s p a c k e d i n b l i s t e r s h a v e r e v e a l e d t h a t i f t h e s e a r e exposed to light they tend to absorb moisture It is therefore necessary to store them in suitable cartons so that the blisters are not exposed to light Pharmacists should do this even if the manufacturer has not provided cartons

middot Light and temperature sensitive products should not be stored on counters where the light is intense or direct and there is no protection from temperature and humidity

42 Cleaning and maintenance i) Cleaning of storage areas

The storage areas of the pharmacy should be cleaned periodically and cleanliness should be maintained at all times The Standard Operating Procedure for cleaning should be designed and followed accordingly Schedules for cleanups should be laid down and adequate cleaning equipment should be made available

Tips for maintaining cleanliness middot Provide clean pieces of cloth for wiping at various locations in the pharmacy

Replace with clean cloth at regular intervals middot Keep separate pieces of cloth for floors shelves and medicines middot Use a disinfectant andor soap solution to clean floors middot Ensure removal of dust and prevent accumulation of dirt middot Ensure removal of cobwebs middot Use a vacuum cleaner for cleaning areas not easily reachable middot T a k e c a r e t h at breakages are handled and cleared effectively middot Observe the factors leading to waste generation in the pharmacy and take appropriate

measures to tackle the problem middot Record all cleaning procedures performed and maintain all the documents required

For ex a m p l e -bullbullThe floor of the pharmacy may be swept with a broom and swabbed with soap water every morning bullbullThe floor may be swabbed with a disinfectant every week bullbullThe entire premises including shelves and cupboards may be cleaned with a cloth (to remove dust and to check for medicines approaching expiry date or expired medicines) every three months bullbullAll the steps followed should be r e c o r d e d

The floor shelves drawers have to be cleaned and a check should be kept on dust cobwebs spillages due to breakage etc It is therefore essential to have SOPs for cleaning laying down cleaning frequencies allotting responsibilities and maintaining a daily record in the logbook to document all these activities

54

While cleaning dust settled on dosage forms like bottles tubes etc should be removed Before dispensing the products should also be wiped to remove any dust settled during storage

For refrigerators bullbullDefrosting and cleaning should be done at regular intervals bullbullSwitch off the refrigerator while cleaning bullbullCleaning should be done quickly and stocks put back immediately

i i ) Pest control Pests are a serious problem in India where insects reptiles and rodents (eg cockroaches l i z a r d s r a t s s i l v e r f i s h (Deemak - in Hindi ) etc) may find access to the pharmacy storage areas Insects like ants and borer ants may often attack wood in the pharmacy causing d am ag e to shelves cupboardsPest c ontr o l in a p h a r m a c y c a n b e a d i f f i c u l t t a s k b u t t o avoid possible contamination and physical damage to stock it is necessary to keep pests out of the pharmacy premisesPest control measures should be implemented with proper p r e c a u t i o n s t a k i n g u t m o s t c a r e t o a v o i d contamination of medicines

55

Th e following pest control measures c a n be ta ke n f r om tim e to tim e -bullbullRat bait and traps can be placed at various locations bullbullInsecticutors can be used on a permanent basis bullbullInsecticidal sprays and repellants can be used from time to time

i i i ) Fire precautions

Combustible trash such as cartons boxes and other packing waste must not be allowed to accumulate in the store Waste should be deposited in appropriate waste bins and be d i s p o s e d o f f o n a d a i l y b a s i s

F i re detection and fire fighting equipment must be maintained and regularly inspected The pharmacy personnel should receive adequate training in fire fighting techniques and emergency actionFire prevention measures should include a prominently displayed ldquoNoSmokingrdquo sign careful handling and disposal of combustible waste materials and checking of electrical connections at regular intervals

iv) Security middot Doors shutters of the pharmacy should be strong and be fitted with secure locks middot Counters should be designed so that unauthorized personnelclients do not have

access to areas where prescription medicines are stored Access to such areas should be restricted to the pharmacy staff

middot All the pharmacy staff handling supplies should be accountable for their ac t i o n s

56

middot bullSpecial care must be taken in case of Schedule X and manufactured drugs (under NDPS Act) Such medicines should be kept under lock and key and the key should be kept with the Chief Pharmacist or i n h i s a b s e n c e t h e s e n i o r p h a r m a c i s t

v) Breakagespillage and damaged product Products that have been damagedspoiled during storage and handling spillages and broken glassware should be disposed off according to procedures laid down by the pharmacy Broken and damaged products s h o u l d b e p l a c e d i n a segregated area to be returned to the supplier

vi) Inspection Senior staff should inspect all pharmacy areas regularly The shelves and drawers should b e c h e c k e d d a i l y f o r signs of pests and dust Ceiling and walls should be checked for dirt and cobwebs Stock should be checked on a regular basis for deterioration due to climatic conditions

43 Product recalls Products found to be defective should be quickly recalled (withdrawn from the market) The instructions are generally issued either by the manufacturer or the regulatory agency The level of recall is determined by both the degree of risk and the extent of distribution of the product and in India is mainly directed at the distribution chain

On receiving the details of the defective substandard spurious batchbatches of a medicine to be recalled from the manufacturer or the stockist or the FDA the pharmacy should immediately check if the particular b a t c h i s i n s t o c k a n d i f s o s u s p e n d i t s s a l e immediately

Similarly if the regulatory authority in the country bans a particular medicine or FDC the pharmacy should immediately check and remove all the different brands of that particular medicine under consideration

The details of medicines and their batches to be recalled should be available in the q u a r a n t i n e a r e a w h e r e stocks are received and checked This is to ensure that such medicines do not come into the pharmacy

middot The pharmacy should develop SOPs for recall of medicines middot The pharmacy staff should be immediately informed about such medicines and

the details should be displayed in writing in a prominent place in the pharmacy middot Rapid action helps avoid unnecessary exposure to such medicines once the

problem has been d e t e c t e d middot The progress of the recall procedure in the pharmacy should be monitored every

few days to ensure complete compliance middot All stocks of the recalled products should be stored separately from the saleable

stock These can be stored in the expiry cupboard segregated from the expired goods and be appropriately labeled ldquoRecal l e d G o o d s - Not for Salerdquo

The supplier should be notified and asked to replace defective products middot All the details of the procedures followed should be duly recorded in a Recall

Register maintained specially for the purpose The register should include d etails such as -middot Date of the recall middot Nam e of the product

57

bullbull

middot Details of the product (name of manufacturer batch number expiry date) middot Nu m b er of units purchased sold a n d sto c k in ha nd middot Reason for recall middot Nam e of the supplier to whom produc ts w e r e returned along with the date and quantity middot Name and signature of the designated personnel carrying out the recall procedure and recording details middot Name and signature of the chief pharmacist verifying the recall procedures and recording details 4 4 Returned medicines

Medicines may be returned to the pharmacy by clients due to the following reasons -bull

bullbull Unused medicines bullbull Course not completed bullbull Therapy changed by doctor bullbull Side effects experienced by patient bull

bullbull DamagedDefective medicines bullbull Missing or defaced label bullbull Missing tablets in a stripblister bullbull Leakage in bottles bullbull Leakage in strips bull

bullbull Expired medicines

Appropriate SOPs should be framed and followed for their acceptancerefusal and disposal middot bull For unused medicines returned by clients the p harmacy personnel should verify

that these were purchased from their pharmacy They should then be checked for integrity of the packing the dosage form and the expiry date and verified with the client whether they were stored in appropriate conditions This again is at the discretion of each pharmacy

middot The damageddefective medicines returned to the pharmacy should be taken back and stored separately Existing stock of the same product should be checked for similar defects

middot Expired medicines should be accepted from clients at the discretion of the pharmacist and be immediately shifted to the expired goods cupboard These can be stored segregated from the pharmacys own expired goods and be appropriately labelled ldquoExpired Goods returned by clients- Not For Salerdquo

It is advisable not to accept returned medicines requiring cold chain storage (refrigeration) because it cannot be ensured that the cold chain was maintained when the medicines were in the hands of the patientclient middot Appropriate adjustments in t he stocks should be made for medicines

returnedexchanged to update the inventory middot The medicines should then be returned to the respective shelves middot A lsquoReturned Goodsrsquo register needs to be maintained to record all details of returned

medicines

R egister should include such details as-

58

middot N a m e o f t h e p a t i e n t middot Nam e of the product and quantity r e tu r n e d middot Product details such as the batch number and expiry date middot Condition in which received middot Reason for returning products middot Compensatory measures taken wi t h r e s p e c t t o c l i e n t middot Action taken with respect to product middot Name and signature of the personnel accepting the returned medicines and recording details middot Name and signature of the chief pharmacist verifying the recorded details

What the pharmacist would have learnt from this module The storage of medicines is a critical factor in the distribution cycle bullbull Stocks received by the pharmacy should be quarantined in a separate area and necessary checks s h o u ld be performed to ascertain the qua lity a nd quantity of stocks received bullbull Whatever pattern and means of storage used the products should be stored so as to maintain their potency and integrity bullbull Storage conditions should be monitored and maintained on a regular basis bullbull Optimum stock levels should be maintained and regularly monitored for expiry bullbull The design of storage areas should facilitate appropriate storage of medicines bullbull Cleanliness should be maintained in the pharmacy bullbull Adequate measures should be taken in case of returned medicines and recalled products

Optimum storage of medicines is mandatory whether at the distribution stage at the pharmacy or ultimately within the homes of patients The pharmacist has an important r o l e t o p l a y i n t h e s t o r a g e o f m e d i c i n e s i n m a i n t a i n i n g d r u g p o t ency and efficacy and thus facilitating optimum therapeutic benefits Good Pharmacy Practice - IPA -CDSCO - WHO Appendix I Quality Assurance Templates of letters for use if found not of Standard Quality [Frozen and expired goods ]

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated To Name of the Supplier with address

Sub Not of Standard Quality GoMP-Supply of Drugs and medicines-(Codename) Return of Stocks to the Suppliers-reg(New drug policy 2009) Previous letterinvoice ref Sl No Drug Code Drug name

Manufacturing date Expiry date

Supplier address

B a t c h n o

The above items of PO nodated was drawn by the Drug Inspector (Place) on (______________date) as a statutory sampling and declared ldquoNot of Standard

59

Qualityrdquo on -(______________date) by the Government Analyst for the following reasons

- ldquoThe product sample do not confirm to IP specification for (Drug codename with respect to the content of drugrdquo

- ldquoThe product has already been blacklisted by TNMSC on -(______________date) for the failure of (quantity) of batches of drug codenamerdquo

As per the clause of the te nde r d oc um e nt ldquo I f the sa mple s d o not c onf o r m to statutory standardsthe tenderer will be liable for relevant action under the existing laws and the entire stock in such batch should be taken back by the tenderer within a period of 30 days o f t h e r e c e i p t o f t h e l e t t e r f r o m t h e v e n u e

The stock shall be taken back at the expenses of the tendererthe Procurement Authority have the right to destroy such Not of Standard Quality if the tenderer does not take back the goods within the stipulated time

The Procuring Authority will arrange to destroy the Not of Standard Quality drugs within 90 days after the expiry of 30 days mentioned above without further notice and shall also collect demurrage charges calculated at the rate of 2 per week on the value of the drugs rejected till such destructionrdquo

Hence we regret to inform you that you will have to take back the stocks available of the abovesaid batch at your own cost from the drug stores where you have supplied the above batch

Kindly acknowledge the receipt of this reference at once

P r o c u r e m e n t A u t h o r i t y Seal and Stamp

Copy to Ref No dated

1 ) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated13082010

To

Sub Frozen Drugs-ordered to return to the Suppliers-reg(New drug policy 2009) Previous letterinvoice ref

The following products which were earlier frozen have now been ordered to return to suppliers directly with permission from the State drug Authority In this regard the suppliers have been instructed to take back their failed batch from the drug store of the stores Hence you are now instructed to return the following failed batches to the suppliers by obtaining proper authorization letter and acknowledgements from them

60

Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

Kindly acknowledge the receipt of this reference at once

Procurement Authority Seal and Stamp

Copy to

Ref No dated 2) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated14092010

To

Sub Frozen Drugs-ordered to return to the Suppliers- for issue of gate pass after verification reg(New drug policy 2009) Previous letterinvoice ref

The following products which were earlier frozen have now been released Hence they may be issued Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

Kindly acknowledge the receipt of this reference at once

Procurement Authority Seal and Stamp

Copy to

61

Ref No dated 3) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated

To

Sub Stop instruction-reg(New drug policy 2009) Previous letterinvoice ref

Until further instructions stop issue all the batches of the following item Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

You must intimate the available stock in the stores of the said batch Number to the Procurement Authority immediately Also retrieve quantity if already issued

Procurement Authority Seal and Stamp

Copy to

Ref No dated 4) HOD Procurement Office of

62

Appendix II Material handling in drug stores

Rack approx rates and dimensions

S No

Item Description UOM Approx Rate

1 MEDIUM DUTY RACK SIZE 2900 H X 3090 W X 800 D IN MM (AS PER SPECIFICATION)

Each 2499800

2 MEDIUM DUTY RACK ADD ON UNIT FOR SIZE OF SR NO2

Each 2243100

To locate a Box no 3 Rack no 14 in row3

SAMPLE OF RACK no Bin numbering -------------- S a y R K 1 4 R o w 3 B o x 1 6

SAMPLE LAYOUT of RACKS in a Drug Stores

63

Sample of another warehouse of distribution warehouse system

64

65

Slotted Angle racks with bin cards

66

Plastic Pallets

Plastic pallets ar e l i g h t w e i g h t l o w- c ost and exceed industry standards for strength and durability

NOTE A pallet has bottom deckboards (see sketch) A skid does not have bottom

67

deckboards

Battery Operated Stacker

Electric Stacker Ehh (Manual Push Type) - Manual drive - Lifting electrically with Battery 12 V 88 Ah - For loading and un-loading of trucks - Battery and loading device built - in - Battery charge gauge and charging current gauge Simple and Easy Operation - Lifting and Lowering electrically direct on steering arm - Pulling and pushing through steering arm - Electrically operated relief valve on hydraulic aggregate Safe Operation - Emergency Off Switch - Constant lowering speed - Protection through lowering brake valve - Overload protection through overload brake valve - Load chains covered preventing pinching threat - Electrically interlocking during loading process - Secured battery compartment opens upwardly - Stable buffering of the steering arm in upright position - In accordance with EWG Guidelines 89 240 - In accordance with VBG 12b Prevention of Accidents

Pallet Truck [ Top ]

68

----------------------------------------------------------------------------------------------------------------------------

For Transport Of All Goods On Pallets Safe and Easy Operation - through single hand operation Lifting moving

lowering with steering handle - neutral position of the hydraulic possible - overload pressure relief valve Long Service Life - robust co n s t r u c t i o n

- special hardened axles - hardened chromium plated ram - maintenance free Easy Maneuverability - through rubber steering rollers - nylon fork rollers

A h a n d t r o l l e y

69

Trolley with plastic bins for several items del ivery

70

Digital Weighing balances

Balances amp Scales EF Seriers Precision Electronic Balance

71

1

Ice lined Refrigerators

600 litres refrigrator

72

Walk in cooler

vacuum cleaner

73

2 STORAGE 21 The need for proper storage The storage of medicines and other products is an important requirement of Good Pharmacy Pr actice Appropriate storage of medicines is essential -

middot bullTo ensure that the potency is maintained middot bullTo prevent deteriorationspoilagedegradation middot bullTo ensuremaintain physical integrity

To ascertain that the quality and safety is maintained throughout their shelf life Storage requirements need to be considered on 2 aspects

a) Integrity of medicines Medicines should be stored in such a way so as to maintain their integrity and potency middot Maintain the right temperature required middot Protect from excessive humidity middot Keep medicines away from direct sunlight middot Protect from pests and rodents

b) Physical location middot Should be easy to locate middot Accessible middot Orderlysystematically placed

2 2 D i f f e r e n t p a t t e r n s o f s t o r a g e The pharmacist could follow any of the different patterns of storage The pattern of stora ge should be selected in such a way that it facilitates speedy and efficient dispensing of medicines

The pattern of storage could vary with each pharmacy experience usual practiceroutine of staff and the person-in charge and also depending on space av ailable turnover etc (i) The medicines could be stored c o m p a n y w i s e ie the medicines manufactured by one company should be grouped together and kept in one place Within each company shelfshelves the medicines may be placed in alphabetical order for easy and quick placement and removal Also bottles tubes boxes etc may be segregated within that shelf

38

(ii) The medicines may also be stored in a lphabe t ic al o r de r ie they are placed in order from left to right based on their name The first letter of the name is used to g r o u p t h e m e d i c i n e s t o g e t h e r a n d k e e p t h e m i n o n e l o c a t i o n I n s o m e p h a r m a c i e s a l l t h e strip packing are placed in drawers or boxes in alphabetical order each box or drawer containing strips of one particular alphabet This system ensures that the strips always remain e n c l o s e d i n t h e b o x e s d r a w e r s a n d a r e n o t e x p o s e d t o d u s t T h e d i s a d v a n t a g e i s that it might lead to mix -u p o f strips in the same drawer and it may cause a problem incase of similar looking strips in which case a wrong medicine may be dispensed Secondly cut strips lying around in the drawer may lose their identity if the batch n u m b e r andor expiry date is not seen on the cut portion of the strip

39

(iii) The medicines may be stored according to their therapeutic class ( e g a n t i b i o t i c s anti asthmatics or anti hypertensives) ie the medicines are kept together based on their pharmacological or therapeutic action

(iv) The medicines may be stockedsegregated according to dosage forms eg l i q u i d s (bottles) solid oral dosage forms eye drops rotacaps ointments etc all stored on separate shelves

Always Remember I Storage of prescription medicines should preferably be separate from OTC medicines OTC medicines especially those that a r e a d v e r t i s e d m a y b e d i s p l a y e d f o r c l i e n t s t o select or to ask questions about [OTC-O v e r t h e c o u n t e r ] II Storage according to temperatures is a must no matter which pattern of storage is followed Also within a particular storage area segregated storage may be maintained In a refrigerator for example medicines may be stored in trays racks and the freezer according to the temperature required

40

Whatever pattern of storage is selected all the personnel should ensure that middot The stocks are stored in an orderly manner middot The medicines are kept back in the same place from where they were removed middot All medicines are arranged neatly once in a while

middot The personnel should be careful while storing the medicines middot They should not throw the medicines haphazardly 23 Different means of storage

middot Within each temperature and security zone medicines must be stored so that they are easily accessible and protected against damage

middot Basic means of storage include shelves racks and drawers middot To prevent dust from entering the shelvesracks it is ideal to have glass

shutterssliding glass doors This can however be disadvantageous because accessibilityspeed is hampered in removing a product from the shelf because the glassshuttersliding glass has to be

41

opened m o v e d e v e r y t i m e a p r o d u c t h a s t o b e p i c k e d u p U s e o f a i r c o n d i t i o n e r s f o r t h e p h arm acy with a closed door at the e n t r a n c e o r a n a i r c u r t a i n c a n r e d u c e t h e d u s t problem In such cases the shelvesracks may be left o p e n

bull

middot Direct storage of cartons on the floor should be avoided because besides being an unhealthy practice the contents may also be damaged by moisture bull

middot Store medicines preferably in shelves with glass shutters for visibility middot Closed shelves further prevent dust from going in especially in India where most

pharmacies are located along busy roads middot Some medicines have to be refrigerated or stored in a cool or cold place Having a

refrigerator or two (as per the need of the pharmacy) is essential to store suc h medicines at temperatures mentioned on the label bull

42

Refrigeration middot All cold chain equipment should meet required standards middot Improvement in refrigeration technology has provided frost -free refrigerators

Pharmacists should opt for frost-free refrigerators as they are easy to maintain and protect printed packaging materials Conventional refrigerators may cause water falling from trays below the freezer on medicines stored in the refrigerator thus causing soggy labels

middot bull Frost-free refrigerators also provide separate and large compartments for the freezer portion (required for storing medicines needing sub-z e r o t e m p e r a t u r e ) and the main storage area with separate doors so that opening one door does not disturb the storage temperature in the other compartment

Care should be taken to keep the refrigerator on 24 hours a day It should not be switched off after working hours It is advisable to have an inverter connected to the refrigerator so that the refrigerator re mains working even when there is a power outage

middot The refrigerator door should be closed tightly middot The refrigerator door should not be left open for too long middot Space should be left between medicines stored in a refrigerator to allow air to

circulate middot The ref rigerator should be placed about an arms length away from the wall

This will increase air circulation thus not affecting the cooling within the refrigerator

middot Vaccines should not be stored on refrigerator door shelves as they are exposed to warmer temperatures each time the door is opened Vaccines should always be stored on the middle shelves of the refrigerator

middot Refrigerated medicines should not be left out of the refrigerator for more than a few minutes

43

middot Consumable products like juices energy drinks e t c s h o u l d n o t b e s t o r e d a l o n g with medicines in refrigerators If required they may be kept in a separate refrigerator

middot An adequate number of refrigerators should be planned to store the entire stocks requiring refrigerated storage

middot Adequate procedures should be followed for defrosting cleaning and maintenance of refrigerators

middot Icefreeze packs should be kept in the freezer compartment so that they can be used for transporting cold temperature medicines The packs can be given to clients along with the medicines requiring cold temperature storage so that the temperature is maintained till the client reaches home and can then put the medicines in a refrigerator) Freezer packs can also be used to keep medicines temporarily in case there is a power outage or refrigerator breakdown

Activity

Prepare a SOP (Standard operating procedure chart) for cleaning a refrigerator Discuss it with your staff finalize its maintenance once a month through AMC -A n n u a l Maintenance contract CMC - Comprehensive maintenance contract and put it up on the pharmacy refrigerator Put the Purchase Order details name of manufacturer Phone of Service Engineer and a register to login the Machine service and down timeService reports may be maintained properly

Refrigerator monitoring and maintenance

middot bullIt is important to carry out routine monitoring and maintenance of the refrigerators and to organize an effective repair system

middot bullThe temperature in the refrigerator must be monitored and recorded routinely at least once a day

middot Any breakdown must be reco rded including the period during which the medicines were exposed to uncontrolled temperatures Medicines may then be kept or discarded depending on the problem guidelines or the manufacturers advice

middot Cold chain monitor cards and devices in or on packages that change color or otherwise alert staff to potential damage assist in monitoring (These are likely to be introduced in India soon)

middot It is essential to have a contingency plan in place before a refrigerator breaks down An arrangement can be made to move the contents to a private refrigerator elsewhere in the community or to obtain a regular supply of ice packs until the defect is rectified

Put filled water bottles in the bottom half of the refrigerator door in order to provide cooling in the refri g e r a t o r w h e n t h e r e i s a p o w e r o u t a g e T h i s m i g h t t a k e c a r e o f t h e temperature when there is no current for a couple of hours If the power outage is expected to last for several hours special arrangements such as an inverter UPS have to be made to keep the refrigerator constantly running in the absence of electricity middot Defrost the refrigerator in case of excessive ice formation and preferably at regular

intervals Keep a record of the same

44

2 4 T e m p e r a t u r e c l i m a t i c c o n d i t i o n s

i) Temperature control middot The medicines in a pharmacy need to be stored at appropriate temperatures to

maintain their stability middot An air-conditioned environment where temperature can be controlled is

recommended for pharmacies Air conditioning offers the option of setting the t e m p e rature as per requirements

middot bullIt is ideal to have an air conditioner to maintain the temperature below 25 C as most medicines require storage below this temperature Secondly this temperature is pleasing to both the staff and the visiting customers too

middot In the absence of an air conditioner circulating fans may be used middot This need is felt even more in certain parts of India where temperatures soar above 45

C and some areas where it falls to sub zero temperatures In such cases temperature maintenance is essential to prevent deterioration of medicines due to unnecessary exposure to drastic temperature fluctuations

middot This need is felt even more in certain parts of India where temperatures soar above 45 C and some areas where it falls to sub zero temperat u r e s I n s u c h c a s e s temperature maintenance is essential to prevent deterioration of medicines due to unnecessary exposure to drastic temperature fluctuations

i i ) Humidity or moisture control Moisture or humidity can adversely affect the stability of me dicines such as tablets capsules powders

45

Gelatin capsules become soft and swell on absorption of moisture The drug content of tablets may undergo surface hydrolysis The presence of moisture may encourage the growth of microbes It is therefore essential to control humidity

To reduce the effect of humidity the following suggestions may be followed -middot Open the windows to allow air circulation Use a fan to circulate fresh (outside) air middot In humid climate a dehumidifier is useful for preventing mo i s t u r e d a m a g e ( i n t h e absence of an air conditioner) middot For bulk containers of tabletscapsules do not keep the container open for a long time and replace the lid or closure immediately after taking out the required number of medicines for dispensing middot Do not allow the medicines to touch the floor or the walls The walls may be damp and may cause moisture absorption damaging the product

middot Calibrated thermometers and manometers can be used to detect temperature and humidity in the pharmacy

middot Periodici t y of checking the temperature should be fixed middot The climatic conditions should be recorded and documented middot Temperature charts should be available for ready reference

Documentation is one of the core activities for achieving and maintaining quality It is one of the most essential components of validation Temperatures in various areas

46

including refrigerators should be recorded at a predetermined periodicity usually daily at the hottest time of the day and such documents should be preserved i i i ) Storage conditions A number of storage conditions are mentioned on the labels of medicinal products These conditions have to be properly interpreted and appropriately complied with

According to the Drugs and Cosmetics Rules 1945

1 The term cool place means a place having a temperature between 10 C and 25 C

2 The term cold place means a place having a temperature not exceeding 8 C In case of storage conditions for specific products please refer to Schedule P The Drugs and Cosmetic Rules 1 9 4 5

The Indian Pharmacopoeia specifies the following storage conditions -

Wherever the condition for storage is not specified medicines may be stored under normal temperature In a country like India however where normal temperatures soar to h i gh temperatures it is recommended that medicines be stored in a cool place

Activity Prepare a list of the storage requirements mentioned on the label of about 20 products in your pharmacy and check if the temperature is maintained

47

25 Special Storage o f s u p p l i e s If the product has no special instructions normal storage conditions apply This means storage in dry clean w e l l -ventilated premises at temperatures of +15 C to +25 C or depending on the climate up to +30 C (WHO1990) Storage instructions are product specific Different brands of the same generic drug may have different storage requirements as they may have different packaging or formulations It is essential to follow the product manufacturers storage instructions to the maximum extent possible Less stable medicines must be stored in specific conditions to maintain their quality or potency

The following products require special storage facilities

middot Products that must be kept frozen (usually vaccines and sera) middot Products sensitive to h eat an d r e q uir in g r e f r ig e r a tio n ( +2 C to +8 C) middot Products that have reduced shelf life at uncontrolled room temperature and need

mechanical ventilation or air conditioning middot Flammable products that require separate fireproof premises middot Products prone to theft o r m i s u s e

Products needing storage in a controlled environment -

The usable shelf life of the following products may be reduced if stored at uncontrolled humidity or at room temperature in hot climates -

middot Some injectables (eg adrenaline) Most injectable preparations are less stable than solid oral forms (tablets and capsules) Injectable preparations in solution are particularly unstable Many injections must be protected from light as well as heat

middot Intravenous fluids (particularly if packed in p lastic containers) middot Some suppositories pessaries creams and ointments These products may melt at

temperatures greater than 30 C Once this happens it is not advisable to use them because the active ingredient in the formula may get unevenly distributed

middot Products containing rubber latex cellulose or some plastics Condoms most sterile disposable medical devices and surgical products such as syringes needles and catheters require protection from excessive humidity and strong light and heat Any o f these conditions may make products brittle stained amp unusable Sterility cannot be assumed if packaging is damaged

In hot climates these products should be stored in the coolest place possible preferably with air conditioning or air circulation fans

48

Products needing freezing or refrigeration-middot Vaccines blood products and many other medicines lose potency if kept even for a

brief period at temperatures outside the recommended range For these products the cold chain must be maintained at every stage of the distribution system

middot Freezing is as damaging as high temperatures for some products including injectable contraceptives ergometrine insulin adrenaline and the DPT DT TT and Hepatitis B vaccines Such products therefore sho uld not be allowed to freeze (not be kept in the freezer compartment)

middot Short periods at room temperature (during transportation or local distribution for instance) may be acceptable for many products (such as ergometrine a n d i n s u l i n ) e v e n t h o u g h s u c h e x posure can to some extent reduce shelf life Other items such as vaccines should always be transported in cold boxes

Storage of insulin injections-

middot Insulin should always be stored in a refrigerator at the recommended temperature of 2 -8 C

middot Insulin should not be kept in the freezer compartment of the refrigerator middot Insulin should ideally be stored horizontally middot It should not be exposed to sunlight or excessive heat middot Insulin suspensions should not be used if the suspension cannot be properly

resuspended due to cake or clump formationbull

Controlled drugs -Narcotics (for example Pethidine injection morphine preparations) and other specified drugs that may be abused are governed by special legislation and regulations The following security measures are suggested in the pharmacy -middot A safe or reinforced double locked cabinet fitted with a light (preferably with a red

bulb) that comes on when the door is opened

49

middot A special register recording details of each receipt or issue with 2 signatures physi cal counting of medicines after each entry and signatures at handover takeover

middot Independent audit (by supervisors and drug inspectors)

Products prone to theft abuse or misuse -

Some medicinesproducts are particularly prone to theft abuse or misuse These include expensive medicines (eg insulin) certain antibiotics and products prone to abuse or misuse like psychotropics etc

Such medicinesproducts should be stored adequately They require stricter record keeping and more frequent stock taki ng than others Periodic audits should be carried out to check for consumption against actual recorded use (registers prescription records stock records etc) to expose any theft or misuse bull26 Storage and stability of medicines Medicines are not stab le indefinitely They are stable for a specific period of time sometimes for a brief period Poor storage conditions accelerate the drug degradation (decomposition) Temperature light and moisture are the most important contributing factors for drug instability It is important to identify and be aware of the potential for instability There is a need to comply with storage requirements to ensure quality medicines for patients It is also important to offer advice to patients too about appropriate storage o f medicines at home The dispensing label should state the storage condition required and be backed up by a verbal reminder especially where special storage is required bull

50

In case stability and storage problems are seen with formulations they should be reported immediately to the representative of the manufacturer and taken out of circulation till the stability problems have been resolved

The pharmacist can easily detect stability problems when products show change in appearance color odor settling of the product contents breaking of emulsions melting of creams oozing of contents from the containers and any such physical changes

3 STOCK CONTROL AND EXPIRY MONITORING 3 1 S t o c k C o n t r o l For economic reasons pharmacists do not like to have stock on their shelves for long periods of time The aim should always be to keep stock at a level that will just meet demand Normally most manufactured medicines have a long shelf life Even then it is essential that there is efficient stock rot ation so that the older stock is used first It is also a good practice to check the expiry date as an integral part of the dispensing process When short shelf life products are involved stock levels may have to be modified to prevent medicines regularl y expiring on the shelves

32 Stock rotation and expiry monitoring In order to avoid accumulation of expired and obsolete stock medicines should be stored and issued according to the following guidelines -middot The stock control system must record the ex p i r y d a t e a n d t h e d a t e o f r e c e i p t middot Stock must be stored so that earliest expiring batches are picked and issued first middot The First In First Out (FIFO) system - In this system the stock which is received

first is sold first This system however may not be useful for pharmacies because most of the stocks carry an expiry date For pharmacies the FEFO system is more practical

51

middot The First Expiry First Out (FEFO) system - In this system the stock having an earlier expiry is sold first The stock with longer shelf life should be placed farthest to the back (or at the bottom in case o f sta c k e d b oxe s) T h is is pa r tic u la r ly impor ta n t with products that have short shelf lives such as vaccines some vitamins antibiotics etc and reduces losses due to expiry

middot E x p i r y dates should be noted on the stock record upon receipt Stock nearing expiry should not be accepted unless it can be used before expiry

Computerization and expiry monitoring In the pharmacy computerization facilitates both checking stocks and expiry mo nitoring and helps-bullbullKeeping a check on products nearing expiry bullbullKeeping a check on non- moving and slow moving products bullbullTo facilitate the removal of medicines nearing expiry from shelves in time to send them back to the wholesaler or supplier

Periodic checking for expiry The expiry date for medicinal products is a critical aspect in pharmaceutical dispensing and due importance should be given to it Periodic checking for expiry of medicines will ensure that the patient will never receive products that have crossed their expiry date During periodical checking of expiry the personnel involved should remove medicines that are nearing expiry bullbullIn -house threshold periods should be set and followed for retrieval of such medicines from the shelves bullbullSuch medicines should be stored separately These should either be dispensed immediately (thus ensuring that they are used before the expiry date) o r t h e y s h o u l d b e returned to the suppliers bullbullA separate area should be designated (cupboard or shelf)marked[FROZEN ZONE] which is adequately marked EXPIRED GOODS- NOT FOR SALE to store all expired stocks FROZEN ZONE

52

Remember Expired medicines are a NATIONAL WASTE So stock only what you can sell Avoid expiries save precious medicines for the nation

Treatment and disposing of expired medicines bullbullProcedures need to be in place for the treatment of expired medicines bullbullThe expired medicines need to be collected and be sent back to the supplier or company for appropriate disposal bullbullRecords must be maintained for expired medicines and how they are disposed off bullbullIn case of medicines that are not returnable to suppliers procedures for disposal need to be followed by the pharmacy in conjunction with the FDA The following procedure can be followed if medicines cannot be returned to suppliers ( T h e b a s i c p h i l o s o p h y of appropriate disposal is to prevent their re- circulation and use) bullbullC u t t h e c o n t ainer in such a manner that the label is also cut In case of tablets and c a p s u l e s d e s t r o y them by disposing them in a bucket of water bullbullUse landfill procedures (deep burial into the ground as per stipulations of Medical Waste Disposal Act prevalent in the respective state) bullbullPour the liquids into the sink and wash away with sufficient quantity of water bullbullKeep a record of such disposal with full details of medicines destroyed Although these measures are usually adopted care has to be taken with such tr e a t m e n t a s studies have shown that flushing of medicines has resulted in tracessmall quantities of medicines being found in waterways and groundwater having potential health and environmental effects

4 O T H E R A S P E C T S 41 Design of storage areas The following important factors need to be considered in design of storage areas -middot The retail outlets in hot areas in summers should be air-conditioned Similarly in

a r e a s o f e x t r e m e c o l d t h e p r e m i s e s w o u l d r e q u i r e w a r m i n g e s p e c i a l l y i n w i n t e r s t o maintain cool temperatures The placement of air -conditioners and heating devices should be such that medicines are not directly exposed to the cold or heat

middot Due consideration should be given to storage requirements of formulations while designing shelves and cupboards in retail outlets Sufficient shelf height should be provided so that all liquid products can be stored vertically As far as possible the shelves should be covered with glass panels to protect medicines from dust and p r e v e n t r a p i d f l u c t u a t i o n s i n temperature

middot Medicines should be stored according to the storage instructions on the labels bullIt is ideal to have a door at the pharmacy entrance to prevent dust from coming in as well as reduceprevent cooled air from going out This may not however be considered feasiblepracticable by many pharmacy owners for fear that clients may not enter the pharmacy because the door may act as a barrier An air curtain is a good alternative to a door

middot There should be minimal direct sunlight falling on the products Particular consideration should be given to premises directly facing the sun

middot bullThe arrangement of lighting in the interior of the premises should also be in a manner that the lights are not focused on the products It has been shown that light causes not only chemical damage but also can catalyze physical changes like moisture uptak e by the products Care should be taken to ensure that only diffused light falls on them

53

middot As far as possible provision should be made for a temperature and humidity indicator device in a pharmacy These devices are now easily available

middot Stability studies o f m e d i c i n e s p a c k e d i n b l i s t e r s h a v e r e v e a l e d t h a t i f t h e s e a r e exposed to light they tend to absorb moisture It is therefore necessary to store them in suitable cartons so that the blisters are not exposed to light Pharmacists should do this even if the manufacturer has not provided cartons

middot Light and temperature sensitive products should not be stored on counters where the light is intense or direct and there is no protection from temperature and humidity

42 Cleaning and maintenance i) Cleaning of storage areas

The storage areas of the pharmacy should be cleaned periodically and cleanliness should be maintained at all times The Standard Operating Procedure for cleaning should be designed and followed accordingly Schedules for cleanups should be laid down and adequate cleaning equipment should be made available

Tips for maintaining cleanliness middot Provide clean pieces of cloth for wiping at various locations in the pharmacy

Replace with clean cloth at regular intervals middot Keep separate pieces of cloth for floors shelves and medicines middot Use a disinfectant andor soap solution to clean floors middot Ensure removal of dust and prevent accumulation of dirt middot Ensure removal of cobwebs middot Use a vacuum cleaner for cleaning areas not easily reachable middot T a k e c a r e t h at breakages are handled and cleared effectively middot Observe the factors leading to waste generation in the pharmacy and take appropriate

measures to tackle the problem middot Record all cleaning procedures performed and maintain all the documents required

For ex a m p l e -bullbullThe floor of the pharmacy may be swept with a broom and swabbed with soap water every morning bullbullThe floor may be swabbed with a disinfectant every week bullbullThe entire premises including shelves and cupboards may be cleaned with a cloth (to remove dust and to check for medicines approaching expiry date or expired medicines) every three months bullbullAll the steps followed should be r e c o r d e d

The floor shelves drawers have to be cleaned and a check should be kept on dust cobwebs spillages due to breakage etc It is therefore essential to have SOPs for cleaning laying down cleaning frequencies allotting responsibilities and maintaining a daily record in the logbook to document all these activities

54

While cleaning dust settled on dosage forms like bottles tubes etc should be removed Before dispensing the products should also be wiped to remove any dust settled during storage

For refrigerators bullbullDefrosting and cleaning should be done at regular intervals bullbullSwitch off the refrigerator while cleaning bullbullCleaning should be done quickly and stocks put back immediately

i i ) Pest control Pests are a serious problem in India where insects reptiles and rodents (eg cockroaches l i z a r d s r a t s s i l v e r f i s h (Deemak - in Hindi ) etc) may find access to the pharmacy storage areas Insects like ants and borer ants may often attack wood in the pharmacy causing d am ag e to shelves cupboardsPest c ontr o l in a p h a r m a c y c a n b e a d i f f i c u l t t a s k b u t t o avoid possible contamination and physical damage to stock it is necessary to keep pests out of the pharmacy premisesPest control measures should be implemented with proper p r e c a u t i o n s t a k i n g u t m o s t c a r e t o a v o i d contamination of medicines

55

Th e following pest control measures c a n be ta ke n f r om tim e to tim e -bullbullRat bait and traps can be placed at various locations bullbullInsecticutors can be used on a permanent basis bullbullInsecticidal sprays and repellants can be used from time to time

i i i ) Fire precautions

Combustible trash such as cartons boxes and other packing waste must not be allowed to accumulate in the store Waste should be deposited in appropriate waste bins and be d i s p o s e d o f f o n a d a i l y b a s i s

F i re detection and fire fighting equipment must be maintained and regularly inspected The pharmacy personnel should receive adequate training in fire fighting techniques and emergency actionFire prevention measures should include a prominently displayed ldquoNoSmokingrdquo sign careful handling and disposal of combustible waste materials and checking of electrical connections at regular intervals

iv) Security middot Doors shutters of the pharmacy should be strong and be fitted with secure locks middot Counters should be designed so that unauthorized personnelclients do not have

access to areas where prescription medicines are stored Access to such areas should be restricted to the pharmacy staff

middot All the pharmacy staff handling supplies should be accountable for their ac t i o n s

56

middot bullSpecial care must be taken in case of Schedule X and manufactured drugs (under NDPS Act) Such medicines should be kept under lock and key and the key should be kept with the Chief Pharmacist or i n h i s a b s e n c e t h e s e n i o r p h a r m a c i s t

v) Breakagespillage and damaged product Products that have been damagedspoiled during storage and handling spillages and broken glassware should be disposed off according to procedures laid down by the pharmacy Broken and damaged products s h o u l d b e p l a c e d i n a segregated area to be returned to the supplier

vi) Inspection Senior staff should inspect all pharmacy areas regularly The shelves and drawers should b e c h e c k e d d a i l y f o r signs of pests and dust Ceiling and walls should be checked for dirt and cobwebs Stock should be checked on a regular basis for deterioration due to climatic conditions

43 Product recalls Products found to be defective should be quickly recalled (withdrawn from the market) The instructions are generally issued either by the manufacturer or the regulatory agency The level of recall is determined by both the degree of risk and the extent of distribution of the product and in India is mainly directed at the distribution chain

On receiving the details of the defective substandard spurious batchbatches of a medicine to be recalled from the manufacturer or the stockist or the FDA the pharmacy should immediately check if the particular b a t c h i s i n s t o c k a n d i f s o s u s p e n d i t s s a l e immediately

Similarly if the regulatory authority in the country bans a particular medicine or FDC the pharmacy should immediately check and remove all the different brands of that particular medicine under consideration

The details of medicines and their batches to be recalled should be available in the q u a r a n t i n e a r e a w h e r e stocks are received and checked This is to ensure that such medicines do not come into the pharmacy

middot The pharmacy should develop SOPs for recall of medicines middot The pharmacy staff should be immediately informed about such medicines and

the details should be displayed in writing in a prominent place in the pharmacy middot Rapid action helps avoid unnecessary exposure to such medicines once the

problem has been d e t e c t e d middot The progress of the recall procedure in the pharmacy should be monitored every

few days to ensure complete compliance middot All stocks of the recalled products should be stored separately from the saleable

stock These can be stored in the expiry cupboard segregated from the expired goods and be appropriately labeled ldquoRecal l e d G o o d s - Not for Salerdquo

The supplier should be notified and asked to replace defective products middot All the details of the procedures followed should be duly recorded in a Recall

Register maintained specially for the purpose The register should include d etails such as -middot Date of the recall middot Nam e of the product

57

bullbull

middot Details of the product (name of manufacturer batch number expiry date) middot Nu m b er of units purchased sold a n d sto c k in ha nd middot Reason for recall middot Nam e of the supplier to whom produc ts w e r e returned along with the date and quantity middot Name and signature of the designated personnel carrying out the recall procedure and recording details middot Name and signature of the chief pharmacist verifying the recall procedures and recording details 4 4 Returned medicines

Medicines may be returned to the pharmacy by clients due to the following reasons -bull

bullbull Unused medicines bullbull Course not completed bullbull Therapy changed by doctor bullbull Side effects experienced by patient bull

bullbull DamagedDefective medicines bullbull Missing or defaced label bullbull Missing tablets in a stripblister bullbull Leakage in bottles bullbull Leakage in strips bull

bullbull Expired medicines

Appropriate SOPs should be framed and followed for their acceptancerefusal and disposal middot bull For unused medicines returned by clients the p harmacy personnel should verify

that these were purchased from their pharmacy They should then be checked for integrity of the packing the dosage form and the expiry date and verified with the client whether they were stored in appropriate conditions This again is at the discretion of each pharmacy

middot The damageddefective medicines returned to the pharmacy should be taken back and stored separately Existing stock of the same product should be checked for similar defects

middot Expired medicines should be accepted from clients at the discretion of the pharmacist and be immediately shifted to the expired goods cupboard These can be stored segregated from the pharmacys own expired goods and be appropriately labelled ldquoExpired Goods returned by clients- Not For Salerdquo

It is advisable not to accept returned medicines requiring cold chain storage (refrigeration) because it cannot be ensured that the cold chain was maintained when the medicines were in the hands of the patientclient middot Appropriate adjustments in t he stocks should be made for medicines

returnedexchanged to update the inventory middot The medicines should then be returned to the respective shelves middot A lsquoReturned Goodsrsquo register needs to be maintained to record all details of returned

medicines

R egister should include such details as-

58

middot N a m e o f t h e p a t i e n t middot Nam e of the product and quantity r e tu r n e d middot Product details such as the batch number and expiry date middot Condition in which received middot Reason for returning products middot Compensatory measures taken wi t h r e s p e c t t o c l i e n t middot Action taken with respect to product middot Name and signature of the personnel accepting the returned medicines and recording details middot Name and signature of the chief pharmacist verifying the recorded details

What the pharmacist would have learnt from this module The storage of medicines is a critical factor in the distribution cycle bullbull Stocks received by the pharmacy should be quarantined in a separate area and necessary checks s h o u ld be performed to ascertain the qua lity a nd quantity of stocks received bullbull Whatever pattern and means of storage used the products should be stored so as to maintain their potency and integrity bullbull Storage conditions should be monitored and maintained on a regular basis bullbull Optimum stock levels should be maintained and regularly monitored for expiry bullbull The design of storage areas should facilitate appropriate storage of medicines bullbull Cleanliness should be maintained in the pharmacy bullbull Adequate measures should be taken in case of returned medicines and recalled products

Optimum storage of medicines is mandatory whether at the distribution stage at the pharmacy or ultimately within the homes of patients The pharmacist has an important r o l e t o p l a y i n t h e s t o r a g e o f m e d i c i n e s i n m a i n t a i n i n g d r u g p o t ency and efficacy and thus facilitating optimum therapeutic benefits Good Pharmacy Practice - IPA -CDSCO - WHO Appendix I Quality Assurance Templates of letters for use if found not of Standard Quality [Frozen and expired goods ]

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated To Name of the Supplier with address

Sub Not of Standard Quality GoMP-Supply of Drugs and medicines-(Codename) Return of Stocks to the Suppliers-reg(New drug policy 2009) Previous letterinvoice ref Sl No Drug Code Drug name

Manufacturing date Expiry date

Supplier address

B a t c h n o

The above items of PO nodated was drawn by the Drug Inspector (Place) on (______________date) as a statutory sampling and declared ldquoNot of Standard

59

Qualityrdquo on -(______________date) by the Government Analyst for the following reasons

- ldquoThe product sample do not confirm to IP specification for (Drug codename with respect to the content of drugrdquo

- ldquoThe product has already been blacklisted by TNMSC on -(______________date) for the failure of (quantity) of batches of drug codenamerdquo

As per the clause of the te nde r d oc um e nt ldquo I f the sa mple s d o not c onf o r m to statutory standardsthe tenderer will be liable for relevant action under the existing laws and the entire stock in such batch should be taken back by the tenderer within a period of 30 days o f t h e r e c e i p t o f t h e l e t t e r f r o m t h e v e n u e

The stock shall be taken back at the expenses of the tendererthe Procurement Authority have the right to destroy such Not of Standard Quality if the tenderer does not take back the goods within the stipulated time

The Procuring Authority will arrange to destroy the Not of Standard Quality drugs within 90 days after the expiry of 30 days mentioned above without further notice and shall also collect demurrage charges calculated at the rate of 2 per week on the value of the drugs rejected till such destructionrdquo

Hence we regret to inform you that you will have to take back the stocks available of the abovesaid batch at your own cost from the drug stores where you have supplied the above batch

Kindly acknowledge the receipt of this reference at once

P r o c u r e m e n t A u t h o r i t y Seal and Stamp

Copy to Ref No dated

1 ) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated13082010

To

Sub Frozen Drugs-ordered to return to the Suppliers-reg(New drug policy 2009) Previous letterinvoice ref

The following products which were earlier frozen have now been ordered to return to suppliers directly with permission from the State drug Authority In this regard the suppliers have been instructed to take back their failed batch from the drug store of the stores Hence you are now instructed to return the following failed batches to the suppliers by obtaining proper authorization letter and acknowledgements from them

60

Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

Kindly acknowledge the receipt of this reference at once

Procurement Authority Seal and Stamp

Copy to

Ref No dated 2) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated14092010

To

Sub Frozen Drugs-ordered to return to the Suppliers- for issue of gate pass after verification reg(New drug policy 2009) Previous letterinvoice ref

The following products which were earlier frozen have now been released Hence they may be issued Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

Kindly acknowledge the receipt of this reference at once

Procurement Authority Seal and Stamp

Copy to

61

Ref No dated 3) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated

To

Sub Stop instruction-reg(New drug policy 2009) Previous letterinvoice ref

Until further instructions stop issue all the batches of the following item Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

You must intimate the available stock in the stores of the said batch Number to the Procurement Authority immediately Also retrieve quantity if already issued

Procurement Authority Seal and Stamp

Copy to

Ref No dated 4) HOD Procurement Office of

62

Appendix II Material handling in drug stores

Rack approx rates and dimensions

S No

Item Description UOM Approx Rate

1 MEDIUM DUTY RACK SIZE 2900 H X 3090 W X 800 D IN MM (AS PER SPECIFICATION)

Each 2499800

2 MEDIUM DUTY RACK ADD ON UNIT FOR SIZE OF SR NO2

Each 2243100

To locate a Box no 3 Rack no 14 in row3

SAMPLE OF RACK no Bin numbering -------------- S a y R K 1 4 R o w 3 B o x 1 6

SAMPLE LAYOUT of RACKS in a Drug Stores

63

Sample of another warehouse of distribution warehouse system

64

65

Slotted Angle racks with bin cards

66

Plastic Pallets

Plastic pallets ar e l i g h t w e i g h t l o w- c ost and exceed industry standards for strength and durability

NOTE A pallet has bottom deckboards (see sketch) A skid does not have bottom

67

deckboards

Battery Operated Stacker

Electric Stacker Ehh (Manual Push Type) - Manual drive - Lifting electrically with Battery 12 V 88 Ah - For loading and un-loading of trucks - Battery and loading device built - in - Battery charge gauge and charging current gauge Simple and Easy Operation - Lifting and Lowering electrically direct on steering arm - Pulling and pushing through steering arm - Electrically operated relief valve on hydraulic aggregate Safe Operation - Emergency Off Switch - Constant lowering speed - Protection through lowering brake valve - Overload protection through overload brake valve - Load chains covered preventing pinching threat - Electrically interlocking during loading process - Secured battery compartment opens upwardly - Stable buffering of the steering arm in upright position - In accordance with EWG Guidelines 89 240 - In accordance with VBG 12b Prevention of Accidents

Pallet Truck [ Top ]

68

----------------------------------------------------------------------------------------------------------------------------

For Transport Of All Goods On Pallets Safe and Easy Operation - through single hand operation Lifting moving

lowering with steering handle - neutral position of the hydraulic possible - overload pressure relief valve Long Service Life - robust co n s t r u c t i o n

- special hardened axles - hardened chromium plated ram - maintenance free Easy Maneuverability - through rubber steering rollers - nylon fork rollers

A h a n d t r o l l e y

69

Trolley with plastic bins for several items del ivery

70

Digital Weighing balances

Balances amp Scales EF Seriers Precision Electronic Balance

71

1

Ice lined Refrigerators

600 litres refrigrator

72

Walk in cooler

vacuum cleaner

73

(ii) The medicines may also be stored in a lphabe t ic al o r de r ie they are placed in order from left to right based on their name The first letter of the name is used to g r o u p t h e m e d i c i n e s t o g e t h e r a n d k e e p t h e m i n o n e l o c a t i o n I n s o m e p h a r m a c i e s a l l t h e strip packing are placed in drawers or boxes in alphabetical order each box or drawer containing strips of one particular alphabet This system ensures that the strips always remain e n c l o s e d i n t h e b o x e s d r a w e r s a n d a r e n o t e x p o s e d t o d u s t T h e d i s a d v a n t a g e i s that it might lead to mix -u p o f strips in the same drawer and it may cause a problem incase of similar looking strips in which case a wrong medicine may be dispensed Secondly cut strips lying around in the drawer may lose their identity if the batch n u m b e r andor expiry date is not seen on the cut portion of the strip

39

(iii) The medicines may be stored according to their therapeutic class ( e g a n t i b i o t i c s anti asthmatics or anti hypertensives) ie the medicines are kept together based on their pharmacological or therapeutic action

(iv) The medicines may be stockedsegregated according to dosage forms eg l i q u i d s (bottles) solid oral dosage forms eye drops rotacaps ointments etc all stored on separate shelves

Always Remember I Storage of prescription medicines should preferably be separate from OTC medicines OTC medicines especially those that a r e a d v e r t i s e d m a y b e d i s p l a y e d f o r c l i e n t s t o select or to ask questions about [OTC-O v e r t h e c o u n t e r ] II Storage according to temperatures is a must no matter which pattern of storage is followed Also within a particular storage area segregated storage may be maintained In a refrigerator for example medicines may be stored in trays racks and the freezer according to the temperature required

40

Whatever pattern of storage is selected all the personnel should ensure that middot The stocks are stored in an orderly manner middot The medicines are kept back in the same place from where they were removed middot All medicines are arranged neatly once in a while

middot The personnel should be careful while storing the medicines middot They should not throw the medicines haphazardly 23 Different means of storage

middot Within each temperature and security zone medicines must be stored so that they are easily accessible and protected against damage

middot Basic means of storage include shelves racks and drawers middot To prevent dust from entering the shelvesracks it is ideal to have glass

shutterssliding glass doors This can however be disadvantageous because accessibilityspeed is hampered in removing a product from the shelf because the glassshuttersliding glass has to be

41

opened m o v e d e v e r y t i m e a p r o d u c t h a s t o b e p i c k e d u p U s e o f a i r c o n d i t i o n e r s f o r t h e p h arm acy with a closed door at the e n t r a n c e o r a n a i r c u r t a i n c a n r e d u c e t h e d u s t problem In such cases the shelvesracks may be left o p e n

bull

middot Direct storage of cartons on the floor should be avoided because besides being an unhealthy practice the contents may also be damaged by moisture bull

middot Store medicines preferably in shelves with glass shutters for visibility middot Closed shelves further prevent dust from going in especially in India where most

pharmacies are located along busy roads middot Some medicines have to be refrigerated or stored in a cool or cold place Having a

refrigerator or two (as per the need of the pharmacy) is essential to store suc h medicines at temperatures mentioned on the label bull

42

Refrigeration middot All cold chain equipment should meet required standards middot Improvement in refrigeration technology has provided frost -free refrigerators

Pharmacists should opt for frost-free refrigerators as they are easy to maintain and protect printed packaging materials Conventional refrigerators may cause water falling from trays below the freezer on medicines stored in the refrigerator thus causing soggy labels

middot bull Frost-free refrigerators also provide separate and large compartments for the freezer portion (required for storing medicines needing sub-z e r o t e m p e r a t u r e ) and the main storage area with separate doors so that opening one door does not disturb the storage temperature in the other compartment

Care should be taken to keep the refrigerator on 24 hours a day It should not be switched off after working hours It is advisable to have an inverter connected to the refrigerator so that the refrigerator re mains working even when there is a power outage

middot The refrigerator door should be closed tightly middot The refrigerator door should not be left open for too long middot Space should be left between medicines stored in a refrigerator to allow air to

circulate middot The ref rigerator should be placed about an arms length away from the wall

This will increase air circulation thus not affecting the cooling within the refrigerator

middot Vaccines should not be stored on refrigerator door shelves as they are exposed to warmer temperatures each time the door is opened Vaccines should always be stored on the middle shelves of the refrigerator

middot Refrigerated medicines should not be left out of the refrigerator for more than a few minutes

43

middot Consumable products like juices energy drinks e t c s h o u l d n o t b e s t o r e d a l o n g with medicines in refrigerators If required they may be kept in a separate refrigerator

middot An adequate number of refrigerators should be planned to store the entire stocks requiring refrigerated storage

middot Adequate procedures should be followed for defrosting cleaning and maintenance of refrigerators

middot Icefreeze packs should be kept in the freezer compartment so that they can be used for transporting cold temperature medicines The packs can be given to clients along with the medicines requiring cold temperature storage so that the temperature is maintained till the client reaches home and can then put the medicines in a refrigerator) Freezer packs can also be used to keep medicines temporarily in case there is a power outage or refrigerator breakdown

Activity

Prepare a SOP (Standard operating procedure chart) for cleaning a refrigerator Discuss it with your staff finalize its maintenance once a month through AMC -A n n u a l Maintenance contract CMC - Comprehensive maintenance contract and put it up on the pharmacy refrigerator Put the Purchase Order details name of manufacturer Phone of Service Engineer and a register to login the Machine service and down timeService reports may be maintained properly

Refrigerator monitoring and maintenance

middot bullIt is important to carry out routine monitoring and maintenance of the refrigerators and to organize an effective repair system

middot bullThe temperature in the refrigerator must be monitored and recorded routinely at least once a day

middot Any breakdown must be reco rded including the period during which the medicines were exposed to uncontrolled temperatures Medicines may then be kept or discarded depending on the problem guidelines or the manufacturers advice

middot Cold chain monitor cards and devices in or on packages that change color or otherwise alert staff to potential damage assist in monitoring (These are likely to be introduced in India soon)

middot It is essential to have a contingency plan in place before a refrigerator breaks down An arrangement can be made to move the contents to a private refrigerator elsewhere in the community or to obtain a regular supply of ice packs until the defect is rectified

Put filled water bottles in the bottom half of the refrigerator door in order to provide cooling in the refri g e r a t o r w h e n t h e r e i s a p o w e r o u t a g e T h i s m i g h t t a k e c a r e o f t h e temperature when there is no current for a couple of hours If the power outage is expected to last for several hours special arrangements such as an inverter UPS have to be made to keep the refrigerator constantly running in the absence of electricity middot Defrost the refrigerator in case of excessive ice formation and preferably at regular

intervals Keep a record of the same

44

2 4 T e m p e r a t u r e c l i m a t i c c o n d i t i o n s

i) Temperature control middot The medicines in a pharmacy need to be stored at appropriate temperatures to

maintain their stability middot An air-conditioned environment where temperature can be controlled is

recommended for pharmacies Air conditioning offers the option of setting the t e m p e rature as per requirements

middot bullIt is ideal to have an air conditioner to maintain the temperature below 25 C as most medicines require storage below this temperature Secondly this temperature is pleasing to both the staff and the visiting customers too

middot In the absence of an air conditioner circulating fans may be used middot This need is felt even more in certain parts of India where temperatures soar above 45

C and some areas where it falls to sub zero temperatures In such cases temperature maintenance is essential to prevent deterioration of medicines due to unnecessary exposure to drastic temperature fluctuations

middot This need is felt even more in certain parts of India where temperatures soar above 45 C and some areas where it falls to sub zero temperat u r e s I n s u c h c a s e s temperature maintenance is essential to prevent deterioration of medicines due to unnecessary exposure to drastic temperature fluctuations

i i ) Humidity or moisture control Moisture or humidity can adversely affect the stability of me dicines such as tablets capsules powders

45

Gelatin capsules become soft and swell on absorption of moisture The drug content of tablets may undergo surface hydrolysis The presence of moisture may encourage the growth of microbes It is therefore essential to control humidity

To reduce the effect of humidity the following suggestions may be followed -middot Open the windows to allow air circulation Use a fan to circulate fresh (outside) air middot In humid climate a dehumidifier is useful for preventing mo i s t u r e d a m a g e ( i n t h e absence of an air conditioner) middot For bulk containers of tabletscapsules do not keep the container open for a long time and replace the lid or closure immediately after taking out the required number of medicines for dispensing middot Do not allow the medicines to touch the floor or the walls The walls may be damp and may cause moisture absorption damaging the product

middot Calibrated thermometers and manometers can be used to detect temperature and humidity in the pharmacy

middot Periodici t y of checking the temperature should be fixed middot The climatic conditions should be recorded and documented middot Temperature charts should be available for ready reference

Documentation is one of the core activities for achieving and maintaining quality It is one of the most essential components of validation Temperatures in various areas

46

including refrigerators should be recorded at a predetermined periodicity usually daily at the hottest time of the day and such documents should be preserved i i i ) Storage conditions A number of storage conditions are mentioned on the labels of medicinal products These conditions have to be properly interpreted and appropriately complied with

According to the Drugs and Cosmetics Rules 1945

1 The term cool place means a place having a temperature between 10 C and 25 C

2 The term cold place means a place having a temperature not exceeding 8 C In case of storage conditions for specific products please refer to Schedule P The Drugs and Cosmetic Rules 1 9 4 5

The Indian Pharmacopoeia specifies the following storage conditions -

Wherever the condition for storage is not specified medicines may be stored under normal temperature In a country like India however where normal temperatures soar to h i gh temperatures it is recommended that medicines be stored in a cool place

Activity Prepare a list of the storage requirements mentioned on the label of about 20 products in your pharmacy and check if the temperature is maintained

47

25 Special Storage o f s u p p l i e s If the product has no special instructions normal storage conditions apply This means storage in dry clean w e l l -ventilated premises at temperatures of +15 C to +25 C or depending on the climate up to +30 C (WHO1990) Storage instructions are product specific Different brands of the same generic drug may have different storage requirements as they may have different packaging or formulations It is essential to follow the product manufacturers storage instructions to the maximum extent possible Less stable medicines must be stored in specific conditions to maintain their quality or potency

The following products require special storage facilities

middot Products that must be kept frozen (usually vaccines and sera) middot Products sensitive to h eat an d r e q uir in g r e f r ig e r a tio n ( +2 C to +8 C) middot Products that have reduced shelf life at uncontrolled room temperature and need

mechanical ventilation or air conditioning middot Flammable products that require separate fireproof premises middot Products prone to theft o r m i s u s e

Products needing storage in a controlled environment -

The usable shelf life of the following products may be reduced if stored at uncontrolled humidity or at room temperature in hot climates -

middot Some injectables (eg adrenaline) Most injectable preparations are less stable than solid oral forms (tablets and capsules) Injectable preparations in solution are particularly unstable Many injections must be protected from light as well as heat

middot Intravenous fluids (particularly if packed in p lastic containers) middot Some suppositories pessaries creams and ointments These products may melt at

temperatures greater than 30 C Once this happens it is not advisable to use them because the active ingredient in the formula may get unevenly distributed

middot Products containing rubber latex cellulose or some plastics Condoms most sterile disposable medical devices and surgical products such as syringes needles and catheters require protection from excessive humidity and strong light and heat Any o f these conditions may make products brittle stained amp unusable Sterility cannot be assumed if packaging is damaged

In hot climates these products should be stored in the coolest place possible preferably with air conditioning or air circulation fans

48

Products needing freezing or refrigeration-middot Vaccines blood products and many other medicines lose potency if kept even for a

brief period at temperatures outside the recommended range For these products the cold chain must be maintained at every stage of the distribution system

middot Freezing is as damaging as high temperatures for some products including injectable contraceptives ergometrine insulin adrenaline and the DPT DT TT and Hepatitis B vaccines Such products therefore sho uld not be allowed to freeze (not be kept in the freezer compartment)

middot Short periods at room temperature (during transportation or local distribution for instance) may be acceptable for many products (such as ergometrine a n d i n s u l i n ) e v e n t h o u g h s u c h e x posure can to some extent reduce shelf life Other items such as vaccines should always be transported in cold boxes

Storage of insulin injections-

middot Insulin should always be stored in a refrigerator at the recommended temperature of 2 -8 C

middot Insulin should not be kept in the freezer compartment of the refrigerator middot Insulin should ideally be stored horizontally middot It should not be exposed to sunlight or excessive heat middot Insulin suspensions should not be used if the suspension cannot be properly

resuspended due to cake or clump formationbull

Controlled drugs -Narcotics (for example Pethidine injection morphine preparations) and other specified drugs that may be abused are governed by special legislation and regulations The following security measures are suggested in the pharmacy -middot A safe or reinforced double locked cabinet fitted with a light (preferably with a red

bulb) that comes on when the door is opened

49

middot A special register recording details of each receipt or issue with 2 signatures physi cal counting of medicines after each entry and signatures at handover takeover

middot Independent audit (by supervisors and drug inspectors)

Products prone to theft abuse or misuse -

Some medicinesproducts are particularly prone to theft abuse or misuse These include expensive medicines (eg insulin) certain antibiotics and products prone to abuse or misuse like psychotropics etc

Such medicinesproducts should be stored adequately They require stricter record keeping and more frequent stock taki ng than others Periodic audits should be carried out to check for consumption against actual recorded use (registers prescription records stock records etc) to expose any theft or misuse bull26 Storage and stability of medicines Medicines are not stab le indefinitely They are stable for a specific period of time sometimes for a brief period Poor storage conditions accelerate the drug degradation (decomposition) Temperature light and moisture are the most important contributing factors for drug instability It is important to identify and be aware of the potential for instability There is a need to comply with storage requirements to ensure quality medicines for patients It is also important to offer advice to patients too about appropriate storage o f medicines at home The dispensing label should state the storage condition required and be backed up by a verbal reminder especially where special storage is required bull

50

In case stability and storage problems are seen with formulations they should be reported immediately to the representative of the manufacturer and taken out of circulation till the stability problems have been resolved

The pharmacist can easily detect stability problems when products show change in appearance color odor settling of the product contents breaking of emulsions melting of creams oozing of contents from the containers and any such physical changes

3 STOCK CONTROL AND EXPIRY MONITORING 3 1 S t o c k C o n t r o l For economic reasons pharmacists do not like to have stock on their shelves for long periods of time The aim should always be to keep stock at a level that will just meet demand Normally most manufactured medicines have a long shelf life Even then it is essential that there is efficient stock rot ation so that the older stock is used first It is also a good practice to check the expiry date as an integral part of the dispensing process When short shelf life products are involved stock levels may have to be modified to prevent medicines regularl y expiring on the shelves

32 Stock rotation and expiry monitoring In order to avoid accumulation of expired and obsolete stock medicines should be stored and issued according to the following guidelines -middot The stock control system must record the ex p i r y d a t e a n d t h e d a t e o f r e c e i p t middot Stock must be stored so that earliest expiring batches are picked and issued first middot The First In First Out (FIFO) system - In this system the stock which is received

first is sold first This system however may not be useful for pharmacies because most of the stocks carry an expiry date For pharmacies the FEFO system is more practical

51

middot The First Expiry First Out (FEFO) system - In this system the stock having an earlier expiry is sold first The stock with longer shelf life should be placed farthest to the back (or at the bottom in case o f sta c k e d b oxe s) T h is is pa r tic u la r ly impor ta n t with products that have short shelf lives such as vaccines some vitamins antibiotics etc and reduces losses due to expiry

middot E x p i r y dates should be noted on the stock record upon receipt Stock nearing expiry should not be accepted unless it can be used before expiry

Computerization and expiry monitoring In the pharmacy computerization facilitates both checking stocks and expiry mo nitoring and helps-bullbullKeeping a check on products nearing expiry bullbullKeeping a check on non- moving and slow moving products bullbullTo facilitate the removal of medicines nearing expiry from shelves in time to send them back to the wholesaler or supplier

Periodic checking for expiry The expiry date for medicinal products is a critical aspect in pharmaceutical dispensing and due importance should be given to it Periodic checking for expiry of medicines will ensure that the patient will never receive products that have crossed their expiry date During periodical checking of expiry the personnel involved should remove medicines that are nearing expiry bullbullIn -house threshold periods should be set and followed for retrieval of such medicines from the shelves bullbullSuch medicines should be stored separately These should either be dispensed immediately (thus ensuring that they are used before the expiry date) o r t h e y s h o u l d b e returned to the suppliers bullbullA separate area should be designated (cupboard or shelf)marked[FROZEN ZONE] which is adequately marked EXPIRED GOODS- NOT FOR SALE to store all expired stocks FROZEN ZONE

52

Remember Expired medicines are a NATIONAL WASTE So stock only what you can sell Avoid expiries save precious medicines for the nation

Treatment and disposing of expired medicines bullbullProcedures need to be in place for the treatment of expired medicines bullbullThe expired medicines need to be collected and be sent back to the supplier or company for appropriate disposal bullbullRecords must be maintained for expired medicines and how they are disposed off bullbullIn case of medicines that are not returnable to suppliers procedures for disposal need to be followed by the pharmacy in conjunction with the FDA The following procedure can be followed if medicines cannot be returned to suppliers ( T h e b a s i c p h i l o s o p h y of appropriate disposal is to prevent their re- circulation and use) bullbullC u t t h e c o n t ainer in such a manner that the label is also cut In case of tablets and c a p s u l e s d e s t r o y them by disposing them in a bucket of water bullbullUse landfill procedures (deep burial into the ground as per stipulations of Medical Waste Disposal Act prevalent in the respective state) bullbullPour the liquids into the sink and wash away with sufficient quantity of water bullbullKeep a record of such disposal with full details of medicines destroyed Although these measures are usually adopted care has to be taken with such tr e a t m e n t a s studies have shown that flushing of medicines has resulted in tracessmall quantities of medicines being found in waterways and groundwater having potential health and environmental effects

4 O T H E R A S P E C T S 41 Design of storage areas The following important factors need to be considered in design of storage areas -middot The retail outlets in hot areas in summers should be air-conditioned Similarly in

a r e a s o f e x t r e m e c o l d t h e p r e m i s e s w o u l d r e q u i r e w a r m i n g e s p e c i a l l y i n w i n t e r s t o maintain cool temperatures The placement of air -conditioners and heating devices should be such that medicines are not directly exposed to the cold or heat

middot Due consideration should be given to storage requirements of formulations while designing shelves and cupboards in retail outlets Sufficient shelf height should be provided so that all liquid products can be stored vertically As far as possible the shelves should be covered with glass panels to protect medicines from dust and p r e v e n t r a p i d f l u c t u a t i o n s i n temperature

middot Medicines should be stored according to the storage instructions on the labels bullIt is ideal to have a door at the pharmacy entrance to prevent dust from coming in as well as reduceprevent cooled air from going out This may not however be considered feasiblepracticable by many pharmacy owners for fear that clients may not enter the pharmacy because the door may act as a barrier An air curtain is a good alternative to a door

middot There should be minimal direct sunlight falling on the products Particular consideration should be given to premises directly facing the sun

middot bullThe arrangement of lighting in the interior of the premises should also be in a manner that the lights are not focused on the products It has been shown that light causes not only chemical damage but also can catalyze physical changes like moisture uptak e by the products Care should be taken to ensure that only diffused light falls on them

53

middot As far as possible provision should be made for a temperature and humidity indicator device in a pharmacy These devices are now easily available

middot Stability studies o f m e d i c i n e s p a c k e d i n b l i s t e r s h a v e r e v e a l e d t h a t i f t h e s e a r e exposed to light they tend to absorb moisture It is therefore necessary to store them in suitable cartons so that the blisters are not exposed to light Pharmacists should do this even if the manufacturer has not provided cartons

middot Light and temperature sensitive products should not be stored on counters where the light is intense or direct and there is no protection from temperature and humidity

42 Cleaning and maintenance i) Cleaning of storage areas

The storage areas of the pharmacy should be cleaned periodically and cleanliness should be maintained at all times The Standard Operating Procedure for cleaning should be designed and followed accordingly Schedules for cleanups should be laid down and adequate cleaning equipment should be made available

Tips for maintaining cleanliness middot Provide clean pieces of cloth for wiping at various locations in the pharmacy

Replace with clean cloth at regular intervals middot Keep separate pieces of cloth for floors shelves and medicines middot Use a disinfectant andor soap solution to clean floors middot Ensure removal of dust and prevent accumulation of dirt middot Ensure removal of cobwebs middot Use a vacuum cleaner for cleaning areas not easily reachable middot T a k e c a r e t h at breakages are handled and cleared effectively middot Observe the factors leading to waste generation in the pharmacy and take appropriate

measures to tackle the problem middot Record all cleaning procedures performed and maintain all the documents required

For ex a m p l e -bullbullThe floor of the pharmacy may be swept with a broom and swabbed with soap water every morning bullbullThe floor may be swabbed with a disinfectant every week bullbullThe entire premises including shelves and cupboards may be cleaned with a cloth (to remove dust and to check for medicines approaching expiry date or expired medicines) every three months bullbullAll the steps followed should be r e c o r d e d

The floor shelves drawers have to be cleaned and a check should be kept on dust cobwebs spillages due to breakage etc It is therefore essential to have SOPs for cleaning laying down cleaning frequencies allotting responsibilities and maintaining a daily record in the logbook to document all these activities

54

While cleaning dust settled on dosage forms like bottles tubes etc should be removed Before dispensing the products should also be wiped to remove any dust settled during storage

For refrigerators bullbullDefrosting and cleaning should be done at regular intervals bullbullSwitch off the refrigerator while cleaning bullbullCleaning should be done quickly and stocks put back immediately

i i ) Pest control Pests are a serious problem in India where insects reptiles and rodents (eg cockroaches l i z a r d s r a t s s i l v e r f i s h (Deemak - in Hindi ) etc) may find access to the pharmacy storage areas Insects like ants and borer ants may often attack wood in the pharmacy causing d am ag e to shelves cupboardsPest c ontr o l in a p h a r m a c y c a n b e a d i f f i c u l t t a s k b u t t o avoid possible contamination and physical damage to stock it is necessary to keep pests out of the pharmacy premisesPest control measures should be implemented with proper p r e c a u t i o n s t a k i n g u t m o s t c a r e t o a v o i d contamination of medicines

55

Th e following pest control measures c a n be ta ke n f r om tim e to tim e -bullbullRat bait and traps can be placed at various locations bullbullInsecticutors can be used on a permanent basis bullbullInsecticidal sprays and repellants can be used from time to time

i i i ) Fire precautions

Combustible trash such as cartons boxes and other packing waste must not be allowed to accumulate in the store Waste should be deposited in appropriate waste bins and be d i s p o s e d o f f o n a d a i l y b a s i s

F i re detection and fire fighting equipment must be maintained and regularly inspected The pharmacy personnel should receive adequate training in fire fighting techniques and emergency actionFire prevention measures should include a prominently displayed ldquoNoSmokingrdquo sign careful handling and disposal of combustible waste materials and checking of electrical connections at regular intervals

iv) Security middot Doors shutters of the pharmacy should be strong and be fitted with secure locks middot Counters should be designed so that unauthorized personnelclients do not have

access to areas where prescription medicines are stored Access to such areas should be restricted to the pharmacy staff

middot All the pharmacy staff handling supplies should be accountable for their ac t i o n s

56

middot bullSpecial care must be taken in case of Schedule X and manufactured drugs (under NDPS Act) Such medicines should be kept under lock and key and the key should be kept with the Chief Pharmacist or i n h i s a b s e n c e t h e s e n i o r p h a r m a c i s t

v) Breakagespillage and damaged product Products that have been damagedspoiled during storage and handling spillages and broken glassware should be disposed off according to procedures laid down by the pharmacy Broken and damaged products s h o u l d b e p l a c e d i n a segregated area to be returned to the supplier

vi) Inspection Senior staff should inspect all pharmacy areas regularly The shelves and drawers should b e c h e c k e d d a i l y f o r signs of pests and dust Ceiling and walls should be checked for dirt and cobwebs Stock should be checked on a regular basis for deterioration due to climatic conditions

43 Product recalls Products found to be defective should be quickly recalled (withdrawn from the market) The instructions are generally issued either by the manufacturer or the regulatory agency The level of recall is determined by both the degree of risk and the extent of distribution of the product and in India is mainly directed at the distribution chain

On receiving the details of the defective substandard spurious batchbatches of a medicine to be recalled from the manufacturer or the stockist or the FDA the pharmacy should immediately check if the particular b a t c h i s i n s t o c k a n d i f s o s u s p e n d i t s s a l e immediately

Similarly if the regulatory authority in the country bans a particular medicine or FDC the pharmacy should immediately check and remove all the different brands of that particular medicine under consideration

The details of medicines and their batches to be recalled should be available in the q u a r a n t i n e a r e a w h e r e stocks are received and checked This is to ensure that such medicines do not come into the pharmacy

middot The pharmacy should develop SOPs for recall of medicines middot The pharmacy staff should be immediately informed about such medicines and

the details should be displayed in writing in a prominent place in the pharmacy middot Rapid action helps avoid unnecessary exposure to such medicines once the

problem has been d e t e c t e d middot The progress of the recall procedure in the pharmacy should be monitored every

few days to ensure complete compliance middot All stocks of the recalled products should be stored separately from the saleable

stock These can be stored in the expiry cupboard segregated from the expired goods and be appropriately labeled ldquoRecal l e d G o o d s - Not for Salerdquo

The supplier should be notified and asked to replace defective products middot All the details of the procedures followed should be duly recorded in a Recall

Register maintained specially for the purpose The register should include d etails such as -middot Date of the recall middot Nam e of the product

57

bullbull

middot Details of the product (name of manufacturer batch number expiry date) middot Nu m b er of units purchased sold a n d sto c k in ha nd middot Reason for recall middot Nam e of the supplier to whom produc ts w e r e returned along with the date and quantity middot Name and signature of the designated personnel carrying out the recall procedure and recording details middot Name and signature of the chief pharmacist verifying the recall procedures and recording details 4 4 Returned medicines

Medicines may be returned to the pharmacy by clients due to the following reasons -bull

bullbull Unused medicines bullbull Course not completed bullbull Therapy changed by doctor bullbull Side effects experienced by patient bull

bullbull DamagedDefective medicines bullbull Missing or defaced label bullbull Missing tablets in a stripblister bullbull Leakage in bottles bullbull Leakage in strips bull

bullbull Expired medicines

Appropriate SOPs should be framed and followed for their acceptancerefusal and disposal middot bull For unused medicines returned by clients the p harmacy personnel should verify

that these were purchased from their pharmacy They should then be checked for integrity of the packing the dosage form and the expiry date and verified with the client whether they were stored in appropriate conditions This again is at the discretion of each pharmacy

middot The damageddefective medicines returned to the pharmacy should be taken back and stored separately Existing stock of the same product should be checked for similar defects

middot Expired medicines should be accepted from clients at the discretion of the pharmacist and be immediately shifted to the expired goods cupboard These can be stored segregated from the pharmacys own expired goods and be appropriately labelled ldquoExpired Goods returned by clients- Not For Salerdquo

It is advisable not to accept returned medicines requiring cold chain storage (refrigeration) because it cannot be ensured that the cold chain was maintained when the medicines were in the hands of the patientclient middot Appropriate adjustments in t he stocks should be made for medicines

returnedexchanged to update the inventory middot The medicines should then be returned to the respective shelves middot A lsquoReturned Goodsrsquo register needs to be maintained to record all details of returned

medicines

R egister should include such details as-

58

middot N a m e o f t h e p a t i e n t middot Nam e of the product and quantity r e tu r n e d middot Product details such as the batch number and expiry date middot Condition in which received middot Reason for returning products middot Compensatory measures taken wi t h r e s p e c t t o c l i e n t middot Action taken with respect to product middot Name and signature of the personnel accepting the returned medicines and recording details middot Name and signature of the chief pharmacist verifying the recorded details

What the pharmacist would have learnt from this module The storage of medicines is a critical factor in the distribution cycle bullbull Stocks received by the pharmacy should be quarantined in a separate area and necessary checks s h o u ld be performed to ascertain the qua lity a nd quantity of stocks received bullbull Whatever pattern and means of storage used the products should be stored so as to maintain their potency and integrity bullbull Storage conditions should be monitored and maintained on a regular basis bullbull Optimum stock levels should be maintained and regularly monitored for expiry bullbull The design of storage areas should facilitate appropriate storage of medicines bullbull Cleanliness should be maintained in the pharmacy bullbull Adequate measures should be taken in case of returned medicines and recalled products

Optimum storage of medicines is mandatory whether at the distribution stage at the pharmacy or ultimately within the homes of patients The pharmacist has an important r o l e t o p l a y i n t h e s t o r a g e o f m e d i c i n e s i n m a i n t a i n i n g d r u g p o t ency and efficacy and thus facilitating optimum therapeutic benefits Good Pharmacy Practice - IPA -CDSCO - WHO Appendix I Quality Assurance Templates of letters for use if found not of Standard Quality [Frozen and expired goods ]

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated To Name of the Supplier with address

Sub Not of Standard Quality GoMP-Supply of Drugs and medicines-(Codename) Return of Stocks to the Suppliers-reg(New drug policy 2009) Previous letterinvoice ref Sl No Drug Code Drug name

Manufacturing date Expiry date

Supplier address

B a t c h n o

The above items of PO nodated was drawn by the Drug Inspector (Place) on (______________date) as a statutory sampling and declared ldquoNot of Standard

59

Qualityrdquo on -(______________date) by the Government Analyst for the following reasons

- ldquoThe product sample do not confirm to IP specification for (Drug codename with respect to the content of drugrdquo

- ldquoThe product has already been blacklisted by TNMSC on -(______________date) for the failure of (quantity) of batches of drug codenamerdquo

As per the clause of the te nde r d oc um e nt ldquo I f the sa mple s d o not c onf o r m to statutory standardsthe tenderer will be liable for relevant action under the existing laws and the entire stock in such batch should be taken back by the tenderer within a period of 30 days o f t h e r e c e i p t o f t h e l e t t e r f r o m t h e v e n u e

The stock shall be taken back at the expenses of the tendererthe Procurement Authority have the right to destroy such Not of Standard Quality if the tenderer does not take back the goods within the stipulated time

The Procuring Authority will arrange to destroy the Not of Standard Quality drugs within 90 days after the expiry of 30 days mentioned above without further notice and shall also collect demurrage charges calculated at the rate of 2 per week on the value of the drugs rejected till such destructionrdquo

Hence we regret to inform you that you will have to take back the stocks available of the abovesaid batch at your own cost from the drug stores where you have supplied the above batch

Kindly acknowledge the receipt of this reference at once

P r o c u r e m e n t A u t h o r i t y Seal and Stamp

Copy to Ref No dated

1 ) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated13082010

To

Sub Frozen Drugs-ordered to return to the Suppliers-reg(New drug policy 2009) Previous letterinvoice ref

The following products which were earlier frozen have now been ordered to return to suppliers directly with permission from the State drug Authority In this regard the suppliers have been instructed to take back their failed batch from the drug store of the stores Hence you are now instructed to return the following failed batches to the suppliers by obtaining proper authorization letter and acknowledgements from them

60

Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

Kindly acknowledge the receipt of this reference at once

Procurement Authority Seal and Stamp

Copy to

Ref No dated 2) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated14092010

To

Sub Frozen Drugs-ordered to return to the Suppliers- for issue of gate pass after verification reg(New drug policy 2009) Previous letterinvoice ref

The following products which were earlier frozen have now been released Hence they may be issued Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

Kindly acknowledge the receipt of this reference at once

Procurement Authority Seal and Stamp

Copy to

61

Ref No dated 3) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated

To

Sub Stop instruction-reg(New drug policy 2009) Previous letterinvoice ref

Until further instructions stop issue all the batches of the following item Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

You must intimate the available stock in the stores of the said batch Number to the Procurement Authority immediately Also retrieve quantity if already issued

Procurement Authority Seal and Stamp

Copy to

Ref No dated 4) HOD Procurement Office of

62

Appendix II Material handling in drug stores

Rack approx rates and dimensions

S No

Item Description UOM Approx Rate

1 MEDIUM DUTY RACK SIZE 2900 H X 3090 W X 800 D IN MM (AS PER SPECIFICATION)

Each 2499800

2 MEDIUM DUTY RACK ADD ON UNIT FOR SIZE OF SR NO2

Each 2243100

To locate a Box no 3 Rack no 14 in row3

SAMPLE OF RACK no Bin numbering -------------- S a y R K 1 4 R o w 3 B o x 1 6

SAMPLE LAYOUT of RACKS in a Drug Stores

63

Sample of another warehouse of distribution warehouse system

64

65

Slotted Angle racks with bin cards

66

Plastic Pallets

Plastic pallets ar e l i g h t w e i g h t l o w- c ost and exceed industry standards for strength and durability

NOTE A pallet has bottom deckboards (see sketch) A skid does not have bottom

67

deckboards

Battery Operated Stacker

Electric Stacker Ehh (Manual Push Type) - Manual drive - Lifting electrically with Battery 12 V 88 Ah - For loading and un-loading of trucks - Battery and loading device built - in - Battery charge gauge and charging current gauge Simple and Easy Operation - Lifting and Lowering electrically direct on steering arm - Pulling and pushing through steering arm - Electrically operated relief valve on hydraulic aggregate Safe Operation - Emergency Off Switch - Constant lowering speed - Protection through lowering brake valve - Overload protection through overload brake valve - Load chains covered preventing pinching threat - Electrically interlocking during loading process - Secured battery compartment opens upwardly - Stable buffering of the steering arm in upright position - In accordance with EWG Guidelines 89 240 - In accordance with VBG 12b Prevention of Accidents

Pallet Truck [ Top ]

68

----------------------------------------------------------------------------------------------------------------------------

For Transport Of All Goods On Pallets Safe and Easy Operation - through single hand operation Lifting moving

lowering with steering handle - neutral position of the hydraulic possible - overload pressure relief valve Long Service Life - robust co n s t r u c t i o n

- special hardened axles - hardened chromium plated ram - maintenance free Easy Maneuverability - through rubber steering rollers - nylon fork rollers

A h a n d t r o l l e y

69

Trolley with plastic bins for several items del ivery

70

Digital Weighing balances

Balances amp Scales EF Seriers Precision Electronic Balance

71

1

Ice lined Refrigerators

600 litres refrigrator

72

Walk in cooler

vacuum cleaner

73

(iii) The medicines may be stored according to their therapeutic class ( e g a n t i b i o t i c s anti asthmatics or anti hypertensives) ie the medicines are kept together based on their pharmacological or therapeutic action

(iv) The medicines may be stockedsegregated according to dosage forms eg l i q u i d s (bottles) solid oral dosage forms eye drops rotacaps ointments etc all stored on separate shelves

Always Remember I Storage of prescription medicines should preferably be separate from OTC medicines OTC medicines especially those that a r e a d v e r t i s e d m a y b e d i s p l a y e d f o r c l i e n t s t o select or to ask questions about [OTC-O v e r t h e c o u n t e r ] II Storage according to temperatures is a must no matter which pattern of storage is followed Also within a particular storage area segregated storage may be maintained In a refrigerator for example medicines may be stored in trays racks and the freezer according to the temperature required

40

Whatever pattern of storage is selected all the personnel should ensure that middot The stocks are stored in an orderly manner middot The medicines are kept back in the same place from where they were removed middot All medicines are arranged neatly once in a while

middot The personnel should be careful while storing the medicines middot They should not throw the medicines haphazardly 23 Different means of storage

middot Within each temperature and security zone medicines must be stored so that they are easily accessible and protected against damage

middot Basic means of storage include shelves racks and drawers middot To prevent dust from entering the shelvesracks it is ideal to have glass

shutterssliding glass doors This can however be disadvantageous because accessibilityspeed is hampered in removing a product from the shelf because the glassshuttersliding glass has to be

41

opened m o v e d e v e r y t i m e a p r o d u c t h a s t o b e p i c k e d u p U s e o f a i r c o n d i t i o n e r s f o r t h e p h arm acy with a closed door at the e n t r a n c e o r a n a i r c u r t a i n c a n r e d u c e t h e d u s t problem In such cases the shelvesracks may be left o p e n

bull

middot Direct storage of cartons on the floor should be avoided because besides being an unhealthy practice the contents may also be damaged by moisture bull

middot Store medicines preferably in shelves with glass shutters for visibility middot Closed shelves further prevent dust from going in especially in India where most

pharmacies are located along busy roads middot Some medicines have to be refrigerated or stored in a cool or cold place Having a

refrigerator or two (as per the need of the pharmacy) is essential to store suc h medicines at temperatures mentioned on the label bull

42

Refrigeration middot All cold chain equipment should meet required standards middot Improvement in refrigeration technology has provided frost -free refrigerators

Pharmacists should opt for frost-free refrigerators as they are easy to maintain and protect printed packaging materials Conventional refrigerators may cause water falling from trays below the freezer on medicines stored in the refrigerator thus causing soggy labels

middot bull Frost-free refrigerators also provide separate and large compartments for the freezer portion (required for storing medicines needing sub-z e r o t e m p e r a t u r e ) and the main storage area with separate doors so that opening one door does not disturb the storage temperature in the other compartment

Care should be taken to keep the refrigerator on 24 hours a day It should not be switched off after working hours It is advisable to have an inverter connected to the refrigerator so that the refrigerator re mains working even when there is a power outage

middot The refrigerator door should be closed tightly middot The refrigerator door should not be left open for too long middot Space should be left between medicines stored in a refrigerator to allow air to

circulate middot The ref rigerator should be placed about an arms length away from the wall

This will increase air circulation thus not affecting the cooling within the refrigerator

middot Vaccines should not be stored on refrigerator door shelves as they are exposed to warmer temperatures each time the door is opened Vaccines should always be stored on the middle shelves of the refrigerator

middot Refrigerated medicines should not be left out of the refrigerator for more than a few minutes

43

middot Consumable products like juices energy drinks e t c s h o u l d n o t b e s t o r e d a l o n g with medicines in refrigerators If required they may be kept in a separate refrigerator

middot An adequate number of refrigerators should be planned to store the entire stocks requiring refrigerated storage

middot Adequate procedures should be followed for defrosting cleaning and maintenance of refrigerators

middot Icefreeze packs should be kept in the freezer compartment so that they can be used for transporting cold temperature medicines The packs can be given to clients along with the medicines requiring cold temperature storage so that the temperature is maintained till the client reaches home and can then put the medicines in a refrigerator) Freezer packs can also be used to keep medicines temporarily in case there is a power outage or refrigerator breakdown

Activity

Prepare a SOP (Standard operating procedure chart) for cleaning a refrigerator Discuss it with your staff finalize its maintenance once a month through AMC -A n n u a l Maintenance contract CMC - Comprehensive maintenance contract and put it up on the pharmacy refrigerator Put the Purchase Order details name of manufacturer Phone of Service Engineer and a register to login the Machine service and down timeService reports may be maintained properly

Refrigerator monitoring and maintenance

middot bullIt is important to carry out routine monitoring and maintenance of the refrigerators and to organize an effective repair system

middot bullThe temperature in the refrigerator must be monitored and recorded routinely at least once a day

middot Any breakdown must be reco rded including the period during which the medicines were exposed to uncontrolled temperatures Medicines may then be kept or discarded depending on the problem guidelines or the manufacturers advice

middot Cold chain monitor cards and devices in or on packages that change color or otherwise alert staff to potential damage assist in monitoring (These are likely to be introduced in India soon)

middot It is essential to have a contingency plan in place before a refrigerator breaks down An arrangement can be made to move the contents to a private refrigerator elsewhere in the community or to obtain a regular supply of ice packs until the defect is rectified

Put filled water bottles in the bottom half of the refrigerator door in order to provide cooling in the refri g e r a t o r w h e n t h e r e i s a p o w e r o u t a g e T h i s m i g h t t a k e c a r e o f t h e temperature when there is no current for a couple of hours If the power outage is expected to last for several hours special arrangements such as an inverter UPS have to be made to keep the refrigerator constantly running in the absence of electricity middot Defrost the refrigerator in case of excessive ice formation and preferably at regular

intervals Keep a record of the same

44

2 4 T e m p e r a t u r e c l i m a t i c c o n d i t i o n s

i) Temperature control middot The medicines in a pharmacy need to be stored at appropriate temperatures to

maintain their stability middot An air-conditioned environment where temperature can be controlled is

recommended for pharmacies Air conditioning offers the option of setting the t e m p e rature as per requirements

middot bullIt is ideal to have an air conditioner to maintain the temperature below 25 C as most medicines require storage below this temperature Secondly this temperature is pleasing to both the staff and the visiting customers too

middot In the absence of an air conditioner circulating fans may be used middot This need is felt even more in certain parts of India where temperatures soar above 45

C and some areas where it falls to sub zero temperatures In such cases temperature maintenance is essential to prevent deterioration of medicines due to unnecessary exposure to drastic temperature fluctuations

middot This need is felt even more in certain parts of India where temperatures soar above 45 C and some areas where it falls to sub zero temperat u r e s I n s u c h c a s e s temperature maintenance is essential to prevent deterioration of medicines due to unnecessary exposure to drastic temperature fluctuations

i i ) Humidity or moisture control Moisture or humidity can adversely affect the stability of me dicines such as tablets capsules powders

45

Gelatin capsules become soft and swell on absorption of moisture The drug content of tablets may undergo surface hydrolysis The presence of moisture may encourage the growth of microbes It is therefore essential to control humidity

To reduce the effect of humidity the following suggestions may be followed -middot Open the windows to allow air circulation Use a fan to circulate fresh (outside) air middot In humid climate a dehumidifier is useful for preventing mo i s t u r e d a m a g e ( i n t h e absence of an air conditioner) middot For bulk containers of tabletscapsules do not keep the container open for a long time and replace the lid or closure immediately after taking out the required number of medicines for dispensing middot Do not allow the medicines to touch the floor or the walls The walls may be damp and may cause moisture absorption damaging the product

middot Calibrated thermometers and manometers can be used to detect temperature and humidity in the pharmacy

middot Periodici t y of checking the temperature should be fixed middot The climatic conditions should be recorded and documented middot Temperature charts should be available for ready reference

Documentation is one of the core activities for achieving and maintaining quality It is one of the most essential components of validation Temperatures in various areas

46

including refrigerators should be recorded at a predetermined periodicity usually daily at the hottest time of the day and such documents should be preserved i i i ) Storage conditions A number of storage conditions are mentioned on the labels of medicinal products These conditions have to be properly interpreted and appropriately complied with

According to the Drugs and Cosmetics Rules 1945

1 The term cool place means a place having a temperature between 10 C and 25 C

2 The term cold place means a place having a temperature not exceeding 8 C In case of storage conditions for specific products please refer to Schedule P The Drugs and Cosmetic Rules 1 9 4 5

The Indian Pharmacopoeia specifies the following storage conditions -

Wherever the condition for storage is not specified medicines may be stored under normal temperature In a country like India however where normal temperatures soar to h i gh temperatures it is recommended that medicines be stored in a cool place

Activity Prepare a list of the storage requirements mentioned on the label of about 20 products in your pharmacy and check if the temperature is maintained

47

25 Special Storage o f s u p p l i e s If the product has no special instructions normal storage conditions apply This means storage in dry clean w e l l -ventilated premises at temperatures of +15 C to +25 C or depending on the climate up to +30 C (WHO1990) Storage instructions are product specific Different brands of the same generic drug may have different storage requirements as they may have different packaging or formulations It is essential to follow the product manufacturers storage instructions to the maximum extent possible Less stable medicines must be stored in specific conditions to maintain their quality or potency

The following products require special storage facilities

middot Products that must be kept frozen (usually vaccines and sera) middot Products sensitive to h eat an d r e q uir in g r e f r ig e r a tio n ( +2 C to +8 C) middot Products that have reduced shelf life at uncontrolled room temperature and need

mechanical ventilation or air conditioning middot Flammable products that require separate fireproof premises middot Products prone to theft o r m i s u s e

Products needing storage in a controlled environment -

The usable shelf life of the following products may be reduced if stored at uncontrolled humidity or at room temperature in hot climates -

middot Some injectables (eg adrenaline) Most injectable preparations are less stable than solid oral forms (tablets and capsules) Injectable preparations in solution are particularly unstable Many injections must be protected from light as well as heat

middot Intravenous fluids (particularly if packed in p lastic containers) middot Some suppositories pessaries creams and ointments These products may melt at

temperatures greater than 30 C Once this happens it is not advisable to use them because the active ingredient in the formula may get unevenly distributed

middot Products containing rubber latex cellulose or some plastics Condoms most sterile disposable medical devices and surgical products such as syringes needles and catheters require protection from excessive humidity and strong light and heat Any o f these conditions may make products brittle stained amp unusable Sterility cannot be assumed if packaging is damaged

In hot climates these products should be stored in the coolest place possible preferably with air conditioning or air circulation fans

48

Products needing freezing or refrigeration-middot Vaccines blood products and many other medicines lose potency if kept even for a

brief period at temperatures outside the recommended range For these products the cold chain must be maintained at every stage of the distribution system

middot Freezing is as damaging as high temperatures for some products including injectable contraceptives ergometrine insulin adrenaline and the DPT DT TT and Hepatitis B vaccines Such products therefore sho uld not be allowed to freeze (not be kept in the freezer compartment)

middot Short periods at room temperature (during transportation or local distribution for instance) may be acceptable for many products (such as ergometrine a n d i n s u l i n ) e v e n t h o u g h s u c h e x posure can to some extent reduce shelf life Other items such as vaccines should always be transported in cold boxes

Storage of insulin injections-

middot Insulin should always be stored in a refrigerator at the recommended temperature of 2 -8 C

middot Insulin should not be kept in the freezer compartment of the refrigerator middot Insulin should ideally be stored horizontally middot It should not be exposed to sunlight or excessive heat middot Insulin suspensions should not be used if the suspension cannot be properly

resuspended due to cake or clump formationbull

Controlled drugs -Narcotics (for example Pethidine injection morphine preparations) and other specified drugs that may be abused are governed by special legislation and regulations The following security measures are suggested in the pharmacy -middot A safe or reinforced double locked cabinet fitted with a light (preferably with a red

bulb) that comes on when the door is opened

49

middot A special register recording details of each receipt or issue with 2 signatures physi cal counting of medicines after each entry and signatures at handover takeover

middot Independent audit (by supervisors and drug inspectors)

Products prone to theft abuse or misuse -

Some medicinesproducts are particularly prone to theft abuse or misuse These include expensive medicines (eg insulin) certain antibiotics and products prone to abuse or misuse like psychotropics etc

Such medicinesproducts should be stored adequately They require stricter record keeping and more frequent stock taki ng than others Periodic audits should be carried out to check for consumption against actual recorded use (registers prescription records stock records etc) to expose any theft or misuse bull26 Storage and stability of medicines Medicines are not stab le indefinitely They are stable for a specific period of time sometimes for a brief period Poor storage conditions accelerate the drug degradation (decomposition) Temperature light and moisture are the most important contributing factors for drug instability It is important to identify and be aware of the potential for instability There is a need to comply with storage requirements to ensure quality medicines for patients It is also important to offer advice to patients too about appropriate storage o f medicines at home The dispensing label should state the storage condition required and be backed up by a verbal reminder especially where special storage is required bull

50

In case stability and storage problems are seen with formulations they should be reported immediately to the representative of the manufacturer and taken out of circulation till the stability problems have been resolved

The pharmacist can easily detect stability problems when products show change in appearance color odor settling of the product contents breaking of emulsions melting of creams oozing of contents from the containers and any such physical changes

3 STOCK CONTROL AND EXPIRY MONITORING 3 1 S t o c k C o n t r o l For economic reasons pharmacists do not like to have stock on their shelves for long periods of time The aim should always be to keep stock at a level that will just meet demand Normally most manufactured medicines have a long shelf life Even then it is essential that there is efficient stock rot ation so that the older stock is used first It is also a good practice to check the expiry date as an integral part of the dispensing process When short shelf life products are involved stock levels may have to be modified to prevent medicines regularl y expiring on the shelves

32 Stock rotation and expiry monitoring In order to avoid accumulation of expired and obsolete stock medicines should be stored and issued according to the following guidelines -middot The stock control system must record the ex p i r y d a t e a n d t h e d a t e o f r e c e i p t middot Stock must be stored so that earliest expiring batches are picked and issued first middot The First In First Out (FIFO) system - In this system the stock which is received

first is sold first This system however may not be useful for pharmacies because most of the stocks carry an expiry date For pharmacies the FEFO system is more practical

51

middot The First Expiry First Out (FEFO) system - In this system the stock having an earlier expiry is sold first The stock with longer shelf life should be placed farthest to the back (or at the bottom in case o f sta c k e d b oxe s) T h is is pa r tic u la r ly impor ta n t with products that have short shelf lives such as vaccines some vitamins antibiotics etc and reduces losses due to expiry

middot E x p i r y dates should be noted on the stock record upon receipt Stock nearing expiry should not be accepted unless it can be used before expiry

Computerization and expiry monitoring In the pharmacy computerization facilitates both checking stocks and expiry mo nitoring and helps-bullbullKeeping a check on products nearing expiry bullbullKeeping a check on non- moving and slow moving products bullbullTo facilitate the removal of medicines nearing expiry from shelves in time to send them back to the wholesaler or supplier

Periodic checking for expiry The expiry date for medicinal products is a critical aspect in pharmaceutical dispensing and due importance should be given to it Periodic checking for expiry of medicines will ensure that the patient will never receive products that have crossed their expiry date During periodical checking of expiry the personnel involved should remove medicines that are nearing expiry bullbullIn -house threshold periods should be set and followed for retrieval of such medicines from the shelves bullbullSuch medicines should be stored separately These should either be dispensed immediately (thus ensuring that they are used before the expiry date) o r t h e y s h o u l d b e returned to the suppliers bullbullA separate area should be designated (cupboard or shelf)marked[FROZEN ZONE] which is adequately marked EXPIRED GOODS- NOT FOR SALE to store all expired stocks FROZEN ZONE

52

Remember Expired medicines are a NATIONAL WASTE So stock only what you can sell Avoid expiries save precious medicines for the nation

Treatment and disposing of expired medicines bullbullProcedures need to be in place for the treatment of expired medicines bullbullThe expired medicines need to be collected and be sent back to the supplier or company for appropriate disposal bullbullRecords must be maintained for expired medicines and how they are disposed off bullbullIn case of medicines that are not returnable to suppliers procedures for disposal need to be followed by the pharmacy in conjunction with the FDA The following procedure can be followed if medicines cannot be returned to suppliers ( T h e b a s i c p h i l o s o p h y of appropriate disposal is to prevent their re- circulation and use) bullbullC u t t h e c o n t ainer in such a manner that the label is also cut In case of tablets and c a p s u l e s d e s t r o y them by disposing them in a bucket of water bullbullUse landfill procedures (deep burial into the ground as per stipulations of Medical Waste Disposal Act prevalent in the respective state) bullbullPour the liquids into the sink and wash away with sufficient quantity of water bullbullKeep a record of such disposal with full details of medicines destroyed Although these measures are usually adopted care has to be taken with such tr e a t m e n t a s studies have shown that flushing of medicines has resulted in tracessmall quantities of medicines being found in waterways and groundwater having potential health and environmental effects

4 O T H E R A S P E C T S 41 Design of storage areas The following important factors need to be considered in design of storage areas -middot The retail outlets in hot areas in summers should be air-conditioned Similarly in

a r e a s o f e x t r e m e c o l d t h e p r e m i s e s w o u l d r e q u i r e w a r m i n g e s p e c i a l l y i n w i n t e r s t o maintain cool temperatures The placement of air -conditioners and heating devices should be such that medicines are not directly exposed to the cold or heat

middot Due consideration should be given to storage requirements of formulations while designing shelves and cupboards in retail outlets Sufficient shelf height should be provided so that all liquid products can be stored vertically As far as possible the shelves should be covered with glass panels to protect medicines from dust and p r e v e n t r a p i d f l u c t u a t i o n s i n temperature

middot Medicines should be stored according to the storage instructions on the labels bullIt is ideal to have a door at the pharmacy entrance to prevent dust from coming in as well as reduceprevent cooled air from going out This may not however be considered feasiblepracticable by many pharmacy owners for fear that clients may not enter the pharmacy because the door may act as a barrier An air curtain is a good alternative to a door

middot There should be minimal direct sunlight falling on the products Particular consideration should be given to premises directly facing the sun

middot bullThe arrangement of lighting in the interior of the premises should also be in a manner that the lights are not focused on the products It has been shown that light causes not only chemical damage but also can catalyze physical changes like moisture uptak e by the products Care should be taken to ensure that only diffused light falls on them

53

middot As far as possible provision should be made for a temperature and humidity indicator device in a pharmacy These devices are now easily available

middot Stability studies o f m e d i c i n e s p a c k e d i n b l i s t e r s h a v e r e v e a l e d t h a t i f t h e s e a r e exposed to light they tend to absorb moisture It is therefore necessary to store them in suitable cartons so that the blisters are not exposed to light Pharmacists should do this even if the manufacturer has not provided cartons

middot Light and temperature sensitive products should not be stored on counters where the light is intense or direct and there is no protection from temperature and humidity

42 Cleaning and maintenance i) Cleaning of storage areas

The storage areas of the pharmacy should be cleaned periodically and cleanliness should be maintained at all times The Standard Operating Procedure for cleaning should be designed and followed accordingly Schedules for cleanups should be laid down and adequate cleaning equipment should be made available

Tips for maintaining cleanliness middot Provide clean pieces of cloth for wiping at various locations in the pharmacy

Replace with clean cloth at regular intervals middot Keep separate pieces of cloth for floors shelves and medicines middot Use a disinfectant andor soap solution to clean floors middot Ensure removal of dust and prevent accumulation of dirt middot Ensure removal of cobwebs middot Use a vacuum cleaner for cleaning areas not easily reachable middot T a k e c a r e t h at breakages are handled and cleared effectively middot Observe the factors leading to waste generation in the pharmacy and take appropriate

measures to tackle the problem middot Record all cleaning procedures performed and maintain all the documents required

For ex a m p l e -bullbullThe floor of the pharmacy may be swept with a broom and swabbed with soap water every morning bullbullThe floor may be swabbed with a disinfectant every week bullbullThe entire premises including shelves and cupboards may be cleaned with a cloth (to remove dust and to check for medicines approaching expiry date or expired medicines) every three months bullbullAll the steps followed should be r e c o r d e d

The floor shelves drawers have to be cleaned and a check should be kept on dust cobwebs spillages due to breakage etc It is therefore essential to have SOPs for cleaning laying down cleaning frequencies allotting responsibilities and maintaining a daily record in the logbook to document all these activities

54

While cleaning dust settled on dosage forms like bottles tubes etc should be removed Before dispensing the products should also be wiped to remove any dust settled during storage

For refrigerators bullbullDefrosting and cleaning should be done at regular intervals bullbullSwitch off the refrigerator while cleaning bullbullCleaning should be done quickly and stocks put back immediately

i i ) Pest control Pests are a serious problem in India where insects reptiles and rodents (eg cockroaches l i z a r d s r a t s s i l v e r f i s h (Deemak - in Hindi ) etc) may find access to the pharmacy storage areas Insects like ants and borer ants may often attack wood in the pharmacy causing d am ag e to shelves cupboardsPest c ontr o l in a p h a r m a c y c a n b e a d i f f i c u l t t a s k b u t t o avoid possible contamination and physical damage to stock it is necessary to keep pests out of the pharmacy premisesPest control measures should be implemented with proper p r e c a u t i o n s t a k i n g u t m o s t c a r e t o a v o i d contamination of medicines

55

Th e following pest control measures c a n be ta ke n f r om tim e to tim e -bullbullRat bait and traps can be placed at various locations bullbullInsecticutors can be used on a permanent basis bullbullInsecticidal sprays and repellants can be used from time to time

i i i ) Fire precautions

Combustible trash such as cartons boxes and other packing waste must not be allowed to accumulate in the store Waste should be deposited in appropriate waste bins and be d i s p o s e d o f f o n a d a i l y b a s i s

F i re detection and fire fighting equipment must be maintained and regularly inspected The pharmacy personnel should receive adequate training in fire fighting techniques and emergency actionFire prevention measures should include a prominently displayed ldquoNoSmokingrdquo sign careful handling and disposal of combustible waste materials and checking of electrical connections at regular intervals

iv) Security middot Doors shutters of the pharmacy should be strong and be fitted with secure locks middot Counters should be designed so that unauthorized personnelclients do not have

access to areas where prescription medicines are stored Access to such areas should be restricted to the pharmacy staff

middot All the pharmacy staff handling supplies should be accountable for their ac t i o n s

56

middot bullSpecial care must be taken in case of Schedule X and manufactured drugs (under NDPS Act) Such medicines should be kept under lock and key and the key should be kept with the Chief Pharmacist or i n h i s a b s e n c e t h e s e n i o r p h a r m a c i s t

v) Breakagespillage and damaged product Products that have been damagedspoiled during storage and handling spillages and broken glassware should be disposed off according to procedures laid down by the pharmacy Broken and damaged products s h o u l d b e p l a c e d i n a segregated area to be returned to the supplier

vi) Inspection Senior staff should inspect all pharmacy areas regularly The shelves and drawers should b e c h e c k e d d a i l y f o r signs of pests and dust Ceiling and walls should be checked for dirt and cobwebs Stock should be checked on a regular basis for deterioration due to climatic conditions

43 Product recalls Products found to be defective should be quickly recalled (withdrawn from the market) The instructions are generally issued either by the manufacturer or the regulatory agency The level of recall is determined by both the degree of risk and the extent of distribution of the product and in India is mainly directed at the distribution chain

On receiving the details of the defective substandard spurious batchbatches of a medicine to be recalled from the manufacturer or the stockist or the FDA the pharmacy should immediately check if the particular b a t c h i s i n s t o c k a n d i f s o s u s p e n d i t s s a l e immediately

Similarly if the regulatory authority in the country bans a particular medicine or FDC the pharmacy should immediately check and remove all the different brands of that particular medicine under consideration

The details of medicines and their batches to be recalled should be available in the q u a r a n t i n e a r e a w h e r e stocks are received and checked This is to ensure that such medicines do not come into the pharmacy

middot The pharmacy should develop SOPs for recall of medicines middot The pharmacy staff should be immediately informed about such medicines and

the details should be displayed in writing in a prominent place in the pharmacy middot Rapid action helps avoid unnecessary exposure to such medicines once the

problem has been d e t e c t e d middot The progress of the recall procedure in the pharmacy should be monitored every

few days to ensure complete compliance middot All stocks of the recalled products should be stored separately from the saleable

stock These can be stored in the expiry cupboard segregated from the expired goods and be appropriately labeled ldquoRecal l e d G o o d s - Not for Salerdquo

The supplier should be notified and asked to replace defective products middot All the details of the procedures followed should be duly recorded in a Recall

Register maintained specially for the purpose The register should include d etails such as -middot Date of the recall middot Nam e of the product

57

bullbull

middot Details of the product (name of manufacturer batch number expiry date) middot Nu m b er of units purchased sold a n d sto c k in ha nd middot Reason for recall middot Nam e of the supplier to whom produc ts w e r e returned along with the date and quantity middot Name and signature of the designated personnel carrying out the recall procedure and recording details middot Name and signature of the chief pharmacist verifying the recall procedures and recording details 4 4 Returned medicines

Medicines may be returned to the pharmacy by clients due to the following reasons -bull

bullbull Unused medicines bullbull Course not completed bullbull Therapy changed by doctor bullbull Side effects experienced by patient bull

bullbull DamagedDefective medicines bullbull Missing or defaced label bullbull Missing tablets in a stripblister bullbull Leakage in bottles bullbull Leakage in strips bull

bullbull Expired medicines

Appropriate SOPs should be framed and followed for their acceptancerefusal and disposal middot bull For unused medicines returned by clients the p harmacy personnel should verify

that these were purchased from their pharmacy They should then be checked for integrity of the packing the dosage form and the expiry date and verified with the client whether they were stored in appropriate conditions This again is at the discretion of each pharmacy

middot The damageddefective medicines returned to the pharmacy should be taken back and stored separately Existing stock of the same product should be checked for similar defects

middot Expired medicines should be accepted from clients at the discretion of the pharmacist and be immediately shifted to the expired goods cupboard These can be stored segregated from the pharmacys own expired goods and be appropriately labelled ldquoExpired Goods returned by clients- Not For Salerdquo

It is advisable not to accept returned medicines requiring cold chain storage (refrigeration) because it cannot be ensured that the cold chain was maintained when the medicines were in the hands of the patientclient middot Appropriate adjustments in t he stocks should be made for medicines

returnedexchanged to update the inventory middot The medicines should then be returned to the respective shelves middot A lsquoReturned Goodsrsquo register needs to be maintained to record all details of returned

medicines

R egister should include such details as-

58

middot N a m e o f t h e p a t i e n t middot Nam e of the product and quantity r e tu r n e d middot Product details such as the batch number and expiry date middot Condition in which received middot Reason for returning products middot Compensatory measures taken wi t h r e s p e c t t o c l i e n t middot Action taken with respect to product middot Name and signature of the personnel accepting the returned medicines and recording details middot Name and signature of the chief pharmacist verifying the recorded details

What the pharmacist would have learnt from this module The storage of medicines is a critical factor in the distribution cycle bullbull Stocks received by the pharmacy should be quarantined in a separate area and necessary checks s h o u ld be performed to ascertain the qua lity a nd quantity of stocks received bullbull Whatever pattern and means of storage used the products should be stored so as to maintain their potency and integrity bullbull Storage conditions should be monitored and maintained on a regular basis bullbull Optimum stock levels should be maintained and regularly monitored for expiry bullbull The design of storage areas should facilitate appropriate storage of medicines bullbull Cleanliness should be maintained in the pharmacy bullbull Adequate measures should be taken in case of returned medicines and recalled products

Optimum storage of medicines is mandatory whether at the distribution stage at the pharmacy or ultimately within the homes of patients The pharmacist has an important r o l e t o p l a y i n t h e s t o r a g e o f m e d i c i n e s i n m a i n t a i n i n g d r u g p o t ency and efficacy and thus facilitating optimum therapeutic benefits Good Pharmacy Practice - IPA -CDSCO - WHO Appendix I Quality Assurance Templates of letters for use if found not of Standard Quality [Frozen and expired goods ]

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated To Name of the Supplier with address

Sub Not of Standard Quality GoMP-Supply of Drugs and medicines-(Codename) Return of Stocks to the Suppliers-reg(New drug policy 2009) Previous letterinvoice ref Sl No Drug Code Drug name

Manufacturing date Expiry date

Supplier address

B a t c h n o

The above items of PO nodated was drawn by the Drug Inspector (Place) on (______________date) as a statutory sampling and declared ldquoNot of Standard

59

Qualityrdquo on -(______________date) by the Government Analyst for the following reasons

- ldquoThe product sample do not confirm to IP specification for (Drug codename with respect to the content of drugrdquo

- ldquoThe product has already been blacklisted by TNMSC on -(______________date) for the failure of (quantity) of batches of drug codenamerdquo

As per the clause of the te nde r d oc um e nt ldquo I f the sa mple s d o not c onf o r m to statutory standardsthe tenderer will be liable for relevant action under the existing laws and the entire stock in such batch should be taken back by the tenderer within a period of 30 days o f t h e r e c e i p t o f t h e l e t t e r f r o m t h e v e n u e

The stock shall be taken back at the expenses of the tendererthe Procurement Authority have the right to destroy such Not of Standard Quality if the tenderer does not take back the goods within the stipulated time

The Procuring Authority will arrange to destroy the Not of Standard Quality drugs within 90 days after the expiry of 30 days mentioned above without further notice and shall also collect demurrage charges calculated at the rate of 2 per week on the value of the drugs rejected till such destructionrdquo

Hence we regret to inform you that you will have to take back the stocks available of the abovesaid batch at your own cost from the drug stores where you have supplied the above batch

Kindly acknowledge the receipt of this reference at once

P r o c u r e m e n t A u t h o r i t y Seal and Stamp

Copy to Ref No dated

1 ) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated13082010

To

Sub Frozen Drugs-ordered to return to the Suppliers-reg(New drug policy 2009) Previous letterinvoice ref

The following products which were earlier frozen have now been ordered to return to suppliers directly with permission from the State drug Authority In this regard the suppliers have been instructed to take back their failed batch from the drug store of the stores Hence you are now instructed to return the following failed batches to the suppliers by obtaining proper authorization letter and acknowledgements from them

60

Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

Kindly acknowledge the receipt of this reference at once

Procurement Authority Seal and Stamp

Copy to

Ref No dated 2) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated14092010

To

Sub Frozen Drugs-ordered to return to the Suppliers- for issue of gate pass after verification reg(New drug policy 2009) Previous letterinvoice ref

The following products which were earlier frozen have now been released Hence they may be issued Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

Kindly acknowledge the receipt of this reference at once

Procurement Authority Seal and Stamp

Copy to

61

Ref No dated 3) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated

To

Sub Stop instruction-reg(New drug policy 2009) Previous letterinvoice ref

Until further instructions stop issue all the batches of the following item Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

You must intimate the available stock in the stores of the said batch Number to the Procurement Authority immediately Also retrieve quantity if already issued

Procurement Authority Seal and Stamp

Copy to

Ref No dated 4) HOD Procurement Office of

62

Appendix II Material handling in drug stores

Rack approx rates and dimensions

S No

Item Description UOM Approx Rate

1 MEDIUM DUTY RACK SIZE 2900 H X 3090 W X 800 D IN MM (AS PER SPECIFICATION)

Each 2499800

2 MEDIUM DUTY RACK ADD ON UNIT FOR SIZE OF SR NO2

Each 2243100

To locate a Box no 3 Rack no 14 in row3

SAMPLE OF RACK no Bin numbering -------------- S a y R K 1 4 R o w 3 B o x 1 6

SAMPLE LAYOUT of RACKS in a Drug Stores

63

Sample of another warehouse of distribution warehouse system

64

65

Slotted Angle racks with bin cards

66

Plastic Pallets

Plastic pallets ar e l i g h t w e i g h t l o w- c ost and exceed industry standards for strength and durability

NOTE A pallet has bottom deckboards (see sketch) A skid does not have bottom

67

deckboards

Battery Operated Stacker

Electric Stacker Ehh (Manual Push Type) - Manual drive - Lifting electrically with Battery 12 V 88 Ah - For loading and un-loading of trucks - Battery and loading device built - in - Battery charge gauge and charging current gauge Simple and Easy Operation - Lifting and Lowering electrically direct on steering arm - Pulling and pushing through steering arm - Electrically operated relief valve on hydraulic aggregate Safe Operation - Emergency Off Switch - Constant lowering speed - Protection through lowering brake valve - Overload protection through overload brake valve - Load chains covered preventing pinching threat - Electrically interlocking during loading process - Secured battery compartment opens upwardly - Stable buffering of the steering arm in upright position - In accordance with EWG Guidelines 89 240 - In accordance with VBG 12b Prevention of Accidents

Pallet Truck [ Top ]

68

----------------------------------------------------------------------------------------------------------------------------

For Transport Of All Goods On Pallets Safe and Easy Operation - through single hand operation Lifting moving

lowering with steering handle - neutral position of the hydraulic possible - overload pressure relief valve Long Service Life - robust co n s t r u c t i o n

- special hardened axles - hardened chromium plated ram - maintenance free Easy Maneuverability - through rubber steering rollers - nylon fork rollers

A h a n d t r o l l e y

69

Trolley with plastic bins for several items del ivery

70

Digital Weighing balances

Balances amp Scales EF Seriers Precision Electronic Balance

71

1

Ice lined Refrigerators

600 litres refrigrator

72

Walk in cooler

vacuum cleaner

73

Whatever pattern of storage is selected all the personnel should ensure that middot The stocks are stored in an orderly manner middot The medicines are kept back in the same place from where they were removed middot All medicines are arranged neatly once in a while

middot The personnel should be careful while storing the medicines middot They should not throw the medicines haphazardly 23 Different means of storage

middot Within each temperature and security zone medicines must be stored so that they are easily accessible and protected against damage

middot Basic means of storage include shelves racks and drawers middot To prevent dust from entering the shelvesracks it is ideal to have glass

shutterssliding glass doors This can however be disadvantageous because accessibilityspeed is hampered in removing a product from the shelf because the glassshuttersliding glass has to be

41

opened m o v e d e v e r y t i m e a p r o d u c t h a s t o b e p i c k e d u p U s e o f a i r c o n d i t i o n e r s f o r t h e p h arm acy with a closed door at the e n t r a n c e o r a n a i r c u r t a i n c a n r e d u c e t h e d u s t problem In such cases the shelvesracks may be left o p e n

bull

middot Direct storage of cartons on the floor should be avoided because besides being an unhealthy practice the contents may also be damaged by moisture bull

middot Store medicines preferably in shelves with glass shutters for visibility middot Closed shelves further prevent dust from going in especially in India where most

pharmacies are located along busy roads middot Some medicines have to be refrigerated or stored in a cool or cold place Having a

refrigerator or two (as per the need of the pharmacy) is essential to store suc h medicines at temperatures mentioned on the label bull

42

Refrigeration middot All cold chain equipment should meet required standards middot Improvement in refrigeration technology has provided frost -free refrigerators

Pharmacists should opt for frost-free refrigerators as they are easy to maintain and protect printed packaging materials Conventional refrigerators may cause water falling from trays below the freezer on medicines stored in the refrigerator thus causing soggy labels

middot bull Frost-free refrigerators also provide separate and large compartments for the freezer portion (required for storing medicines needing sub-z e r o t e m p e r a t u r e ) and the main storage area with separate doors so that opening one door does not disturb the storage temperature in the other compartment

Care should be taken to keep the refrigerator on 24 hours a day It should not be switched off after working hours It is advisable to have an inverter connected to the refrigerator so that the refrigerator re mains working even when there is a power outage

middot The refrigerator door should be closed tightly middot The refrigerator door should not be left open for too long middot Space should be left between medicines stored in a refrigerator to allow air to

circulate middot The ref rigerator should be placed about an arms length away from the wall

This will increase air circulation thus not affecting the cooling within the refrigerator

middot Vaccines should not be stored on refrigerator door shelves as they are exposed to warmer temperatures each time the door is opened Vaccines should always be stored on the middle shelves of the refrigerator

middot Refrigerated medicines should not be left out of the refrigerator for more than a few minutes

43

middot Consumable products like juices energy drinks e t c s h o u l d n o t b e s t o r e d a l o n g with medicines in refrigerators If required they may be kept in a separate refrigerator

middot An adequate number of refrigerators should be planned to store the entire stocks requiring refrigerated storage

middot Adequate procedures should be followed for defrosting cleaning and maintenance of refrigerators

middot Icefreeze packs should be kept in the freezer compartment so that they can be used for transporting cold temperature medicines The packs can be given to clients along with the medicines requiring cold temperature storage so that the temperature is maintained till the client reaches home and can then put the medicines in a refrigerator) Freezer packs can also be used to keep medicines temporarily in case there is a power outage or refrigerator breakdown

Activity

Prepare a SOP (Standard operating procedure chart) for cleaning a refrigerator Discuss it with your staff finalize its maintenance once a month through AMC -A n n u a l Maintenance contract CMC - Comprehensive maintenance contract and put it up on the pharmacy refrigerator Put the Purchase Order details name of manufacturer Phone of Service Engineer and a register to login the Machine service and down timeService reports may be maintained properly

Refrigerator monitoring and maintenance

middot bullIt is important to carry out routine monitoring and maintenance of the refrigerators and to organize an effective repair system

middot bullThe temperature in the refrigerator must be monitored and recorded routinely at least once a day

middot Any breakdown must be reco rded including the period during which the medicines were exposed to uncontrolled temperatures Medicines may then be kept or discarded depending on the problem guidelines or the manufacturers advice

middot Cold chain monitor cards and devices in or on packages that change color or otherwise alert staff to potential damage assist in monitoring (These are likely to be introduced in India soon)

middot It is essential to have a contingency plan in place before a refrigerator breaks down An arrangement can be made to move the contents to a private refrigerator elsewhere in the community or to obtain a regular supply of ice packs until the defect is rectified

Put filled water bottles in the bottom half of the refrigerator door in order to provide cooling in the refri g e r a t o r w h e n t h e r e i s a p o w e r o u t a g e T h i s m i g h t t a k e c a r e o f t h e temperature when there is no current for a couple of hours If the power outage is expected to last for several hours special arrangements such as an inverter UPS have to be made to keep the refrigerator constantly running in the absence of electricity middot Defrost the refrigerator in case of excessive ice formation and preferably at regular

intervals Keep a record of the same

44

2 4 T e m p e r a t u r e c l i m a t i c c o n d i t i o n s

i) Temperature control middot The medicines in a pharmacy need to be stored at appropriate temperatures to

maintain their stability middot An air-conditioned environment where temperature can be controlled is

recommended for pharmacies Air conditioning offers the option of setting the t e m p e rature as per requirements

middot bullIt is ideal to have an air conditioner to maintain the temperature below 25 C as most medicines require storage below this temperature Secondly this temperature is pleasing to both the staff and the visiting customers too

middot In the absence of an air conditioner circulating fans may be used middot This need is felt even more in certain parts of India where temperatures soar above 45

C and some areas where it falls to sub zero temperatures In such cases temperature maintenance is essential to prevent deterioration of medicines due to unnecessary exposure to drastic temperature fluctuations

middot This need is felt even more in certain parts of India where temperatures soar above 45 C and some areas where it falls to sub zero temperat u r e s I n s u c h c a s e s temperature maintenance is essential to prevent deterioration of medicines due to unnecessary exposure to drastic temperature fluctuations

i i ) Humidity or moisture control Moisture or humidity can adversely affect the stability of me dicines such as tablets capsules powders

45

Gelatin capsules become soft and swell on absorption of moisture The drug content of tablets may undergo surface hydrolysis The presence of moisture may encourage the growth of microbes It is therefore essential to control humidity

To reduce the effect of humidity the following suggestions may be followed -middot Open the windows to allow air circulation Use a fan to circulate fresh (outside) air middot In humid climate a dehumidifier is useful for preventing mo i s t u r e d a m a g e ( i n t h e absence of an air conditioner) middot For bulk containers of tabletscapsules do not keep the container open for a long time and replace the lid or closure immediately after taking out the required number of medicines for dispensing middot Do not allow the medicines to touch the floor or the walls The walls may be damp and may cause moisture absorption damaging the product

middot Calibrated thermometers and manometers can be used to detect temperature and humidity in the pharmacy

middot Periodici t y of checking the temperature should be fixed middot The climatic conditions should be recorded and documented middot Temperature charts should be available for ready reference

Documentation is one of the core activities for achieving and maintaining quality It is one of the most essential components of validation Temperatures in various areas

46

including refrigerators should be recorded at a predetermined periodicity usually daily at the hottest time of the day and such documents should be preserved i i i ) Storage conditions A number of storage conditions are mentioned on the labels of medicinal products These conditions have to be properly interpreted and appropriately complied with

According to the Drugs and Cosmetics Rules 1945

1 The term cool place means a place having a temperature between 10 C and 25 C

2 The term cold place means a place having a temperature not exceeding 8 C In case of storage conditions for specific products please refer to Schedule P The Drugs and Cosmetic Rules 1 9 4 5

The Indian Pharmacopoeia specifies the following storage conditions -

Wherever the condition for storage is not specified medicines may be stored under normal temperature In a country like India however where normal temperatures soar to h i gh temperatures it is recommended that medicines be stored in a cool place

Activity Prepare a list of the storage requirements mentioned on the label of about 20 products in your pharmacy and check if the temperature is maintained

47

25 Special Storage o f s u p p l i e s If the product has no special instructions normal storage conditions apply This means storage in dry clean w e l l -ventilated premises at temperatures of +15 C to +25 C or depending on the climate up to +30 C (WHO1990) Storage instructions are product specific Different brands of the same generic drug may have different storage requirements as they may have different packaging or formulations It is essential to follow the product manufacturers storage instructions to the maximum extent possible Less stable medicines must be stored in specific conditions to maintain their quality or potency

The following products require special storage facilities

middot Products that must be kept frozen (usually vaccines and sera) middot Products sensitive to h eat an d r e q uir in g r e f r ig e r a tio n ( +2 C to +8 C) middot Products that have reduced shelf life at uncontrolled room temperature and need

mechanical ventilation or air conditioning middot Flammable products that require separate fireproof premises middot Products prone to theft o r m i s u s e

Products needing storage in a controlled environment -

The usable shelf life of the following products may be reduced if stored at uncontrolled humidity or at room temperature in hot climates -

middot Some injectables (eg adrenaline) Most injectable preparations are less stable than solid oral forms (tablets and capsules) Injectable preparations in solution are particularly unstable Many injections must be protected from light as well as heat

middot Intravenous fluids (particularly if packed in p lastic containers) middot Some suppositories pessaries creams and ointments These products may melt at

temperatures greater than 30 C Once this happens it is not advisable to use them because the active ingredient in the formula may get unevenly distributed

middot Products containing rubber latex cellulose or some plastics Condoms most sterile disposable medical devices and surgical products such as syringes needles and catheters require protection from excessive humidity and strong light and heat Any o f these conditions may make products brittle stained amp unusable Sterility cannot be assumed if packaging is damaged

In hot climates these products should be stored in the coolest place possible preferably with air conditioning or air circulation fans

48

Products needing freezing or refrigeration-middot Vaccines blood products and many other medicines lose potency if kept even for a

brief period at temperatures outside the recommended range For these products the cold chain must be maintained at every stage of the distribution system

middot Freezing is as damaging as high temperatures for some products including injectable contraceptives ergometrine insulin adrenaline and the DPT DT TT and Hepatitis B vaccines Such products therefore sho uld not be allowed to freeze (not be kept in the freezer compartment)

middot Short periods at room temperature (during transportation or local distribution for instance) may be acceptable for many products (such as ergometrine a n d i n s u l i n ) e v e n t h o u g h s u c h e x posure can to some extent reduce shelf life Other items such as vaccines should always be transported in cold boxes

Storage of insulin injections-

middot Insulin should always be stored in a refrigerator at the recommended temperature of 2 -8 C

middot Insulin should not be kept in the freezer compartment of the refrigerator middot Insulin should ideally be stored horizontally middot It should not be exposed to sunlight or excessive heat middot Insulin suspensions should not be used if the suspension cannot be properly

resuspended due to cake or clump formationbull

Controlled drugs -Narcotics (for example Pethidine injection morphine preparations) and other specified drugs that may be abused are governed by special legislation and regulations The following security measures are suggested in the pharmacy -middot A safe or reinforced double locked cabinet fitted with a light (preferably with a red

bulb) that comes on when the door is opened

49

middot A special register recording details of each receipt or issue with 2 signatures physi cal counting of medicines after each entry and signatures at handover takeover

middot Independent audit (by supervisors and drug inspectors)

Products prone to theft abuse or misuse -

Some medicinesproducts are particularly prone to theft abuse or misuse These include expensive medicines (eg insulin) certain antibiotics and products prone to abuse or misuse like psychotropics etc

Such medicinesproducts should be stored adequately They require stricter record keeping and more frequent stock taki ng than others Periodic audits should be carried out to check for consumption against actual recorded use (registers prescription records stock records etc) to expose any theft or misuse bull26 Storage and stability of medicines Medicines are not stab le indefinitely They are stable for a specific period of time sometimes for a brief period Poor storage conditions accelerate the drug degradation (decomposition) Temperature light and moisture are the most important contributing factors for drug instability It is important to identify and be aware of the potential for instability There is a need to comply with storage requirements to ensure quality medicines for patients It is also important to offer advice to patients too about appropriate storage o f medicines at home The dispensing label should state the storage condition required and be backed up by a verbal reminder especially where special storage is required bull

50

In case stability and storage problems are seen with formulations they should be reported immediately to the representative of the manufacturer and taken out of circulation till the stability problems have been resolved

The pharmacist can easily detect stability problems when products show change in appearance color odor settling of the product contents breaking of emulsions melting of creams oozing of contents from the containers and any such physical changes

3 STOCK CONTROL AND EXPIRY MONITORING 3 1 S t o c k C o n t r o l For economic reasons pharmacists do not like to have stock on their shelves for long periods of time The aim should always be to keep stock at a level that will just meet demand Normally most manufactured medicines have a long shelf life Even then it is essential that there is efficient stock rot ation so that the older stock is used first It is also a good practice to check the expiry date as an integral part of the dispensing process When short shelf life products are involved stock levels may have to be modified to prevent medicines regularl y expiring on the shelves

32 Stock rotation and expiry monitoring In order to avoid accumulation of expired and obsolete stock medicines should be stored and issued according to the following guidelines -middot The stock control system must record the ex p i r y d a t e a n d t h e d a t e o f r e c e i p t middot Stock must be stored so that earliest expiring batches are picked and issued first middot The First In First Out (FIFO) system - In this system the stock which is received

first is sold first This system however may not be useful for pharmacies because most of the stocks carry an expiry date For pharmacies the FEFO system is more practical

51

middot The First Expiry First Out (FEFO) system - In this system the stock having an earlier expiry is sold first The stock with longer shelf life should be placed farthest to the back (or at the bottom in case o f sta c k e d b oxe s) T h is is pa r tic u la r ly impor ta n t with products that have short shelf lives such as vaccines some vitamins antibiotics etc and reduces losses due to expiry

middot E x p i r y dates should be noted on the stock record upon receipt Stock nearing expiry should not be accepted unless it can be used before expiry

Computerization and expiry monitoring In the pharmacy computerization facilitates both checking stocks and expiry mo nitoring and helps-bullbullKeeping a check on products nearing expiry bullbullKeeping a check on non- moving and slow moving products bullbullTo facilitate the removal of medicines nearing expiry from shelves in time to send them back to the wholesaler or supplier

Periodic checking for expiry The expiry date for medicinal products is a critical aspect in pharmaceutical dispensing and due importance should be given to it Periodic checking for expiry of medicines will ensure that the patient will never receive products that have crossed their expiry date During periodical checking of expiry the personnel involved should remove medicines that are nearing expiry bullbullIn -house threshold periods should be set and followed for retrieval of such medicines from the shelves bullbullSuch medicines should be stored separately These should either be dispensed immediately (thus ensuring that they are used before the expiry date) o r t h e y s h o u l d b e returned to the suppliers bullbullA separate area should be designated (cupboard or shelf)marked[FROZEN ZONE] which is adequately marked EXPIRED GOODS- NOT FOR SALE to store all expired stocks FROZEN ZONE

52

Remember Expired medicines are a NATIONAL WASTE So stock only what you can sell Avoid expiries save precious medicines for the nation

Treatment and disposing of expired medicines bullbullProcedures need to be in place for the treatment of expired medicines bullbullThe expired medicines need to be collected and be sent back to the supplier or company for appropriate disposal bullbullRecords must be maintained for expired medicines and how they are disposed off bullbullIn case of medicines that are not returnable to suppliers procedures for disposal need to be followed by the pharmacy in conjunction with the FDA The following procedure can be followed if medicines cannot be returned to suppliers ( T h e b a s i c p h i l o s o p h y of appropriate disposal is to prevent their re- circulation and use) bullbullC u t t h e c o n t ainer in such a manner that the label is also cut In case of tablets and c a p s u l e s d e s t r o y them by disposing them in a bucket of water bullbullUse landfill procedures (deep burial into the ground as per stipulations of Medical Waste Disposal Act prevalent in the respective state) bullbullPour the liquids into the sink and wash away with sufficient quantity of water bullbullKeep a record of such disposal with full details of medicines destroyed Although these measures are usually adopted care has to be taken with such tr e a t m e n t a s studies have shown that flushing of medicines has resulted in tracessmall quantities of medicines being found in waterways and groundwater having potential health and environmental effects

4 O T H E R A S P E C T S 41 Design of storage areas The following important factors need to be considered in design of storage areas -middot The retail outlets in hot areas in summers should be air-conditioned Similarly in

a r e a s o f e x t r e m e c o l d t h e p r e m i s e s w o u l d r e q u i r e w a r m i n g e s p e c i a l l y i n w i n t e r s t o maintain cool temperatures The placement of air -conditioners and heating devices should be such that medicines are not directly exposed to the cold or heat

middot Due consideration should be given to storage requirements of formulations while designing shelves and cupboards in retail outlets Sufficient shelf height should be provided so that all liquid products can be stored vertically As far as possible the shelves should be covered with glass panels to protect medicines from dust and p r e v e n t r a p i d f l u c t u a t i o n s i n temperature

middot Medicines should be stored according to the storage instructions on the labels bullIt is ideal to have a door at the pharmacy entrance to prevent dust from coming in as well as reduceprevent cooled air from going out This may not however be considered feasiblepracticable by many pharmacy owners for fear that clients may not enter the pharmacy because the door may act as a barrier An air curtain is a good alternative to a door

middot There should be minimal direct sunlight falling on the products Particular consideration should be given to premises directly facing the sun

middot bullThe arrangement of lighting in the interior of the premises should also be in a manner that the lights are not focused on the products It has been shown that light causes not only chemical damage but also can catalyze physical changes like moisture uptak e by the products Care should be taken to ensure that only diffused light falls on them

53

middot As far as possible provision should be made for a temperature and humidity indicator device in a pharmacy These devices are now easily available

middot Stability studies o f m e d i c i n e s p a c k e d i n b l i s t e r s h a v e r e v e a l e d t h a t i f t h e s e a r e exposed to light they tend to absorb moisture It is therefore necessary to store them in suitable cartons so that the blisters are not exposed to light Pharmacists should do this even if the manufacturer has not provided cartons

middot Light and temperature sensitive products should not be stored on counters where the light is intense or direct and there is no protection from temperature and humidity

42 Cleaning and maintenance i) Cleaning of storage areas

The storage areas of the pharmacy should be cleaned periodically and cleanliness should be maintained at all times The Standard Operating Procedure for cleaning should be designed and followed accordingly Schedules for cleanups should be laid down and adequate cleaning equipment should be made available

Tips for maintaining cleanliness middot Provide clean pieces of cloth for wiping at various locations in the pharmacy

Replace with clean cloth at regular intervals middot Keep separate pieces of cloth for floors shelves and medicines middot Use a disinfectant andor soap solution to clean floors middot Ensure removal of dust and prevent accumulation of dirt middot Ensure removal of cobwebs middot Use a vacuum cleaner for cleaning areas not easily reachable middot T a k e c a r e t h at breakages are handled and cleared effectively middot Observe the factors leading to waste generation in the pharmacy and take appropriate

measures to tackle the problem middot Record all cleaning procedures performed and maintain all the documents required

For ex a m p l e -bullbullThe floor of the pharmacy may be swept with a broom and swabbed with soap water every morning bullbullThe floor may be swabbed with a disinfectant every week bullbullThe entire premises including shelves and cupboards may be cleaned with a cloth (to remove dust and to check for medicines approaching expiry date or expired medicines) every three months bullbullAll the steps followed should be r e c o r d e d

The floor shelves drawers have to be cleaned and a check should be kept on dust cobwebs spillages due to breakage etc It is therefore essential to have SOPs for cleaning laying down cleaning frequencies allotting responsibilities and maintaining a daily record in the logbook to document all these activities

54

While cleaning dust settled on dosage forms like bottles tubes etc should be removed Before dispensing the products should also be wiped to remove any dust settled during storage

For refrigerators bullbullDefrosting and cleaning should be done at regular intervals bullbullSwitch off the refrigerator while cleaning bullbullCleaning should be done quickly and stocks put back immediately

i i ) Pest control Pests are a serious problem in India where insects reptiles and rodents (eg cockroaches l i z a r d s r a t s s i l v e r f i s h (Deemak - in Hindi ) etc) may find access to the pharmacy storage areas Insects like ants and borer ants may often attack wood in the pharmacy causing d am ag e to shelves cupboardsPest c ontr o l in a p h a r m a c y c a n b e a d i f f i c u l t t a s k b u t t o avoid possible contamination and physical damage to stock it is necessary to keep pests out of the pharmacy premisesPest control measures should be implemented with proper p r e c a u t i o n s t a k i n g u t m o s t c a r e t o a v o i d contamination of medicines

55

Th e following pest control measures c a n be ta ke n f r om tim e to tim e -bullbullRat bait and traps can be placed at various locations bullbullInsecticutors can be used on a permanent basis bullbullInsecticidal sprays and repellants can be used from time to time

i i i ) Fire precautions

Combustible trash such as cartons boxes and other packing waste must not be allowed to accumulate in the store Waste should be deposited in appropriate waste bins and be d i s p o s e d o f f o n a d a i l y b a s i s

F i re detection and fire fighting equipment must be maintained and regularly inspected The pharmacy personnel should receive adequate training in fire fighting techniques and emergency actionFire prevention measures should include a prominently displayed ldquoNoSmokingrdquo sign careful handling and disposal of combustible waste materials and checking of electrical connections at regular intervals

iv) Security middot Doors shutters of the pharmacy should be strong and be fitted with secure locks middot Counters should be designed so that unauthorized personnelclients do not have

access to areas where prescription medicines are stored Access to such areas should be restricted to the pharmacy staff

middot All the pharmacy staff handling supplies should be accountable for their ac t i o n s

56

middot bullSpecial care must be taken in case of Schedule X and manufactured drugs (under NDPS Act) Such medicines should be kept under lock and key and the key should be kept with the Chief Pharmacist or i n h i s a b s e n c e t h e s e n i o r p h a r m a c i s t

v) Breakagespillage and damaged product Products that have been damagedspoiled during storage and handling spillages and broken glassware should be disposed off according to procedures laid down by the pharmacy Broken and damaged products s h o u l d b e p l a c e d i n a segregated area to be returned to the supplier

vi) Inspection Senior staff should inspect all pharmacy areas regularly The shelves and drawers should b e c h e c k e d d a i l y f o r signs of pests and dust Ceiling and walls should be checked for dirt and cobwebs Stock should be checked on a regular basis for deterioration due to climatic conditions

43 Product recalls Products found to be defective should be quickly recalled (withdrawn from the market) The instructions are generally issued either by the manufacturer or the regulatory agency The level of recall is determined by both the degree of risk and the extent of distribution of the product and in India is mainly directed at the distribution chain

On receiving the details of the defective substandard spurious batchbatches of a medicine to be recalled from the manufacturer or the stockist or the FDA the pharmacy should immediately check if the particular b a t c h i s i n s t o c k a n d i f s o s u s p e n d i t s s a l e immediately

Similarly if the regulatory authority in the country bans a particular medicine or FDC the pharmacy should immediately check and remove all the different brands of that particular medicine under consideration

The details of medicines and their batches to be recalled should be available in the q u a r a n t i n e a r e a w h e r e stocks are received and checked This is to ensure that such medicines do not come into the pharmacy

middot The pharmacy should develop SOPs for recall of medicines middot The pharmacy staff should be immediately informed about such medicines and

the details should be displayed in writing in a prominent place in the pharmacy middot Rapid action helps avoid unnecessary exposure to such medicines once the

problem has been d e t e c t e d middot The progress of the recall procedure in the pharmacy should be monitored every

few days to ensure complete compliance middot All stocks of the recalled products should be stored separately from the saleable

stock These can be stored in the expiry cupboard segregated from the expired goods and be appropriately labeled ldquoRecal l e d G o o d s - Not for Salerdquo

The supplier should be notified and asked to replace defective products middot All the details of the procedures followed should be duly recorded in a Recall

Register maintained specially for the purpose The register should include d etails such as -middot Date of the recall middot Nam e of the product

57

bullbull

middot Details of the product (name of manufacturer batch number expiry date) middot Nu m b er of units purchased sold a n d sto c k in ha nd middot Reason for recall middot Nam e of the supplier to whom produc ts w e r e returned along with the date and quantity middot Name and signature of the designated personnel carrying out the recall procedure and recording details middot Name and signature of the chief pharmacist verifying the recall procedures and recording details 4 4 Returned medicines

Medicines may be returned to the pharmacy by clients due to the following reasons -bull

bullbull Unused medicines bullbull Course not completed bullbull Therapy changed by doctor bullbull Side effects experienced by patient bull

bullbull DamagedDefective medicines bullbull Missing or defaced label bullbull Missing tablets in a stripblister bullbull Leakage in bottles bullbull Leakage in strips bull

bullbull Expired medicines

Appropriate SOPs should be framed and followed for their acceptancerefusal and disposal middot bull For unused medicines returned by clients the p harmacy personnel should verify

that these were purchased from their pharmacy They should then be checked for integrity of the packing the dosage form and the expiry date and verified with the client whether they were stored in appropriate conditions This again is at the discretion of each pharmacy

middot The damageddefective medicines returned to the pharmacy should be taken back and stored separately Existing stock of the same product should be checked for similar defects

middot Expired medicines should be accepted from clients at the discretion of the pharmacist and be immediately shifted to the expired goods cupboard These can be stored segregated from the pharmacys own expired goods and be appropriately labelled ldquoExpired Goods returned by clients- Not For Salerdquo

It is advisable not to accept returned medicines requiring cold chain storage (refrigeration) because it cannot be ensured that the cold chain was maintained when the medicines were in the hands of the patientclient middot Appropriate adjustments in t he stocks should be made for medicines

returnedexchanged to update the inventory middot The medicines should then be returned to the respective shelves middot A lsquoReturned Goodsrsquo register needs to be maintained to record all details of returned

medicines

R egister should include such details as-

58

middot N a m e o f t h e p a t i e n t middot Nam e of the product and quantity r e tu r n e d middot Product details such as the batch number and expiry date middot Condition in which received middot Reason for returning products middot Compensatory measures taken wi t h r e s p e c t t o c l i e n t middot Action taken with respect to product middot Name and signature of the personnel accepting the returned medicines and recording details middot Name and signature of the chief pharmacist verifying the recorded details

What the pharmacist would have learnt from this module The storage of medicines is a critical factor in the distribution cycle bullbull Stocks received by the pharmacy should be quarantined in a separate area and necessary checks s h o u ld be performed to ascertain the qua lity a nd quantity of stocks received bullbull Whatever pattern and means of storage used the products should be stored so as to maintain their potency and integrity bullbull Storage conditions should be monitored and maintained on a regular basis bullbull Optimum stock levels should be maintained and regularly monitored for expiry bullbull The design of storage areas should facilitate appropriate storage of medicines bullbull Cleanliness should be maintained in the pharmacy bullbull Adequate measures should be taken in case of returned medicines and recalled products

Optimum storage of medicines is mandatory whether at the distribution stage at the pharmacy or ultimately within the homes of patients The pharmacist has an important r o l e t o p l a y i n t h e s t o r a g e o f m e d i c i n e s i n m a i n t a i n i n g d r u g p o t ency and efficacy and thus facilitating optimum therapeutic benefits Good Pharmacy Practice - IPA -CDSCO - WHO Appendix I Quality Assurance Templates of letters for use if found not of Standard Quality [Frozen and expired goods ]

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated To Name of the Supplier with address

Sub Not of Standard Quality GoMP-Supply of Drugs and medicines-(Codename) Return of Stocks to the Suppliers-reg(New drug policy 2009) Previous letterinvoice ref Sl No Drug Code Drug name

Manufacturing date Expiry date

Supplier address

B a t c h n o

The above items of PO nodated was drawn by the Drug Inspector (Place) on (______________date) as a statutory sampling and declared ldquoNot of Standard

59

Qualityrdquo on -(______________date) by the Government Analyst for the following reasons

- ldquoThe product sample do not confirm to IP specification for (Drug codename with respect to the content of drugrdquo

- ldquoThe product has already been blacklisted by TNMSC on -(______________date) for the failure of (quantity) of batches of drug codenamerdquo

As per the clause of the te nde r d oc um e nt ldquo I f the sa mple s d o not c onf o r m to statutory standardsthe tenderer will be liable for relevant action under the existing laws and the entire stock in such batch should be taken back by the tenderer within a period of 30 days o f t h e r e c e i p t o f t h e l e t t e r f r o m t h e v e n u e

The stock shall be taken back at the expenses of the tendererthe Procurement Authority have the right to destroy such Not of Standard Quality if the tenderer does not take back the goods within the stipulated time

The Procuring Authority will arrange to destroy the Not of Standard Quality drugs within 90 days after the expiry of 30 days mentioned above without further notice and shall also collect demurrage charges calculated at the rate of 2 per week on the value of the drugs rejected till such destructionrdquo

Hence we regret to inform you that you will have to take back the stocks available of the abovesaid batch at your own cost from the drug stores where you have supplied the above batch

Kindly acknowledge the receipt of this reference at once

P r o c u r e m e n t A u t h o r i t y Seal and Stamp

Copy to Ref No dated

1 ) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated13082010

To

Sub Frozen Drugs-ordered to return to the Suppliers-reg(New drug policy 2009) Previous letterinvoice ref

The following products which were earlier frozen have now been ordered to return to suppliers directly with permission from the State drug Authority In this regard the suppliers have been instructed to take back their failed batch from the drug store of the stores Hence you are now instructed to return the following failed batches to the suppliers by obtaining proper authorization letter and acknowledgements from them

60

Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

Kindly acknowledge the receipt of this reference at once

Procurement Authority Seal and Stamp

Copy to

Ref No dated 2) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated14092010

To

Sub Frozen Drugs-ordered to return to the Suppliers- for issue of gate pass after verification reg(New drug policy 2009) Previous letterinvoice ref

The following products which were earlier frozen have now been released Hence they may be issued Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

Kindly acknowledge the receipt of this reference at once

Procurement Authority Seal and Stamp

Copy to

61

Ref No dated 3) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated

To

Sub Stop instruction-reg(New drug policy 2009) Previous letterinvoice ref

Until further instructions stop issue all the batches of the following item Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

You must intimate the available stock in the stores of the said batch Number to the Procurement Authority immediately Also retrieve quantity if already issued

Procurement Authority Seal and Stamp

Copy to

Ref No dated 4) HOD Procurement Office of

62

Appendix II Material handling in drug stores

Rack approx rates and dimensions

S No

Item Description UOM Approx Rate

1 MEDIUM DUTY RACK SIZE 2900 H X 3090 W X 800 D IN MM (AS PER SPECIFICATION)

Each 2499800

2 MEDIUM DUTY RACK ADD ON UNIT FOR SIZE OF SR NO2

Each 2243100

To locate a Box no 3 Rack no 14 in row3

SAMPLE OF RACK no Bin numbering -------------- S a y R K 1 4 R o w 3 B o x 1 6

SAMPLE LAYOUT of RACKS in a Drug Stores

63

Sample of another warehouse of distribution warehouse system

64

65

Slotted Angle racks with bin cards

66

Plastic Pallets

Plastic pallets ar e l i g h t w e i g h t l o w- c ost and exceed industry standards for strength and durability

NOTE A pallet has bottom deckboards (see sketch) A skid does not have bottom

67

deckboards

Battery Operated Stacker

Electric Stacker Ehh (Manual Push Type) - Manual drive - Lifting electrically with Battery 12 V 88 Ah - For loading and un-loading of trucks - Battery and loading device built - in - Battery charge gauge and charging current gauge Simple and Easy Operation - Lifting and Lowering electrically direct on steering arm - Pulling and pushing through steering arm - Electrically operated relief valve on hydraulic aggregate Safe Operation - Emergency Off Switch - Constant lowering speed - Protection through lowering brake valve - Overload protection through overload brake valve - Load chains covered preventing pinching threat - Electrically interlocking during loading process - Secured battery compartment opens upwardly - Stable buffering of the steering arm in upright position - In accordance with EWG Guidelines 89 240 - In accordance with VBG 12b Prevention of Accidents

Pallet Truck [ Top ]

68

----------------------------------------------------------------------------------------------------------------------------

For Transport Of All Goods On Pallets Safe and Easy Operation - through single hand operation Lifting moving

lowering with steering handle - neutral position of the hydraulic possible - overload pressure relief valve Long Service Life - robust co n s t r u c t i o n

- special hardened axles - hardened chromium plated ram - maintenance free Easy Maneuverability - through rubber steering rollers - nylon fork rollers

A h a n d t r o l l e y

69

Trolley with plastic bins for several items del ivery

70

Digital Weighing balances

Balances amp Scales EF Seriers Precision Electronic Balance

71

1

Ice lined Refrigerators

600 litres refrigrator

72

Walk in cooler

vacuum cleaner

73

opened m o v e d e v e r y t i m e a p r o d u c t h a s t o b e p i c k e d u p U s e o f a i r c o n d i t i o n e r s f o r t h e p h arm acy with a closed door at the e n t r a n c e o r a n a i r c u r t a i n c a n r e d u c e t h e d u s t problem In such cases the shelvesracks may be left o p e n

bull

middot Direct storage of cartons on the floor should be avoided because besides being an unhealthy practice the contents may also be damaged by moisture bull

middot Store medicines preferably in shelves with glass shutters for visibility middot Closed shelves further prevent dust from going in especially in India where most

pharmacies are located along busy roads middot Some medicines have to be refrigerated or stored in a cool or cold place Having a

refrigerator or two (as per the need of the pharmacy) is essential to store suc h medicines at temperatures mentioned on the label bull

42

Refrigeration middot All cold chain equipment should meet required standards middot Improvement in refrigeration technology has provided frost -free refrigerators

Pharmacists should opt for frost-free refrigerators as they are easy to maintain and protect printed packaging materials Conventional refrigerators may cause water falling from trays below the freezer on medicines stored in the refrigerator thus causing soggy labels

middot bull Frost-free refrigerators also provide separate and large compartments for the freezer portion (required for storing medicines needing sub-z e r o t e m p e r a t u r e ) and the main storage area with separate doors so that opening one door does not disturb the storage temperature in the other compartment

Care should be taken to keep the refrigerator on 24 hours a day It should not be switched off after working hours It is advisable to have an inverter connected to the refrigerator so that the refrigerator re mains working even when there is a power outage

middot The refrigerator door should be closed tightly middot The refrigerator door should not be left open for too long middot Space should be left between medicines stored in a refrigerator to allow air to

circulate middot The ref rigerator should be placed about an arms length away from the wall

This will increase air circulation thus not affecting the cooling within the refrigerator

middot Vaccines should not be stored on refrigerator door shelves as they are exposed to warmer temperatures each time the door is opened Vaccines should always be stored on the middle shelves of the refrigerator

middot Refrigerated medicines should not be left out of the refrigerator for more than a few minutes

43

middot Consumable products like juices energy drinks e t c s h o u l d n o t b e s t o r e d a l o n g with medicines in refrigerators If required they may be kept in a separate refrigerator

middot An adequate number of refrigerators should be planned to store the entire stocks requiring refrigerated storage

middot Adequate procedures should be followed for defrosting cleaning and maintenance of refrigerators

middot Icefreeze packs should be kept in the freezer compartment so that they can be used for transporting cold temperature medicines The packs can be given to clients along with the medicines requiring cold temperature storage so that the temperature is maintained till the client reaches home and can then put the medicines in a refrigerator) Freezer packs can also be used to keep medicines temporarily in case there is a power outage or refrigerator breakdown

Activity

Prepare a SOP (Standard operating procedure chart) for cleaning a refrigerator Discuss it with your staff finalize its maintenance once a month through AMC -A n n u a l Maintenance contract CMC - Comprehensive maintenance contract and put it up on the pharmacy refrigerator Put the Purchase Order details name of manufacturer Phone of Service Engineer and a register to login the Machine service and down timeService reports may be maintained properly

Refrigerator monitoring and maintenance

middot bullIt is important to carry out routine monitoring and maintenance of the refrigerators and to organize an effective repair system

middot bullThe temperature in the refrigerator must be monitored and recorded routinely at least once a day

middot Any breakdown must be reco rded including the period during which the medicines were exposed to uncontrolled temperatures Medicines may then be kept or discarded depending on the problem guidelines or the manufacturers advice

middot Cold chain monitor cards and devices in or on packages that change color or otherwise alert staff to potential damage assist in monitoring (These are likely to be introduced in India soon)

middot It is essential to have a contingency plan in place before a refrigerator breaks down An arrangement can be made to move the contents to a private refrigerator elsewhere in the community or to obtain a regular supply of ice packs until the defect is rectified

Put filled water bottles in the bottom half of the refrigerator door in order to provide cooling in the refri g e r a t o r w h e n t h e r e i s a p o w e r o u t a g e T h i s m i g h t t a k e c a r e o f t h e temperature when there is no current for a couple of hours If the power outage is expected to last for several hours special arrangements such as an inverter UPS have to be made to keep the refrigerator constantly running in the absence of electricity middot Defrost the refrigerator in case of excessive ice formation and preferably at regular

intervals Keep a record of the same

44

2 4 T e m p e r a t u r e c l i m a t i c c o n d i t i o n s

i) Temperature control middot The medicines in a pharmacy need to be stored at appropriate temperatures to

maintain their stability middot An air-conditioned environment where temperature can be controlled is

recommended for pharmacies Air conditioning offers the option of setting the t e m p e rature as per requirements

middot bullIt is ideal to have an air conditioner to maintain the temperature below 25 C as most medicines require storage below this temperature Secondly this temperature is pleasing to both the staff and the visiting customers too

middot In the absence of an air conditioner circulating fans may be used middot This need is felt even more in certain parts of India where temperatures soar above 45

C and some areas where it falls to sub zero temperatures In such cases temperature maintenance is essential to prevent deterioration of medicines due to unnecessary exposure to drastic temperature fluctuations

middot This need is felt even more in certain parts of India where temperatures soar above 45 C and some areas where it falls to sub zero temperat u r e s I n s u c h c a s e s temperature maintenance is essential to prevent deterioration of medicines due to unnecessary exposure to drastic temperature fluctuations

i i ) Humidity or moisture control Moisture or humidity can adversely affect the stability of me dicines such as tablets capsules powders

45

Gelatin capsules become soft and swell on absorption of moisture The drug content of tablets may undergo surface hydrolysis The presence of moisture may encourage the growth of microbes It is therefore essential to control humidity

To reduce the effect of humidity the following suggestions may be followed -middot Open the windows to allow air circulation Use a fan to circulate fresh (outside) air middot In humid climate a dehumidifier is useful for preventing mo i s t u r e d a m a g e ( i n t h e absence of an air conditioner) middot For bulk containers of tabletscapsules do not keep the container open for a long time and replace the lid or closure immediately after taking out the required number of medicines for dispensing middot Do not allow the medicines to touch the floor or the walls The walls may be damp and may cause moisture absorption damaging the product

middot Calibrated thermometers and manometers can be used to detect temperature and humidity in the pharmacy

middot Periodici t y of checking the temperature should be fixed middot The climatic conditions should be recorded and documented middot Temperature charts should be available for ready reference

Documentation is one of the core activities for achieving and maintaining quality It is one of the most essential components of validation Temperatures in various areas

46

including refrigerators should be recorded at a predetermined periodicity usually daily at the hottest time of the day and such documents should be preserved i i i ) Storage conditions A number of storage conditions are mentioned on the labels of medicinal products These conditions have to be properly interpreted and appropriately complied with

According to the Drugs and Cosmetics Rules 1945

1 The term cool place means a place having a temperature between 10 C and 25 C

2 The term cold place means a place having a temperature not exceeding 8 C In case of storage conditions for specific products please refer to Schedule P The Drugs and Cosmetic Rules 1 9 4 5

The Indian Pharmacopoeia specifies the following storage conditions -

Wherever the condition for storage is not specified medicines may be stored under normal temperature In a country like India however where normal temperatures soar to h i gh temperatures it is recommended that medicines be stored in a cool place

Activity Prepare a list of the storage requirements mentioned on the label of about 20 products in your pharmacy and check if the temperature is maintained

47

25 Special Storage o f s u p p l i e s If the product has no special instructions normal storage conditions apply This means storage in dry clean w e l l -ventilated premises at temperatures of +15 C to +25 C or depending on the climate up to +30 C (WHO1990) Storage instructions are product specific Different brands of the same generic drug may have different storage requirements as they may have different packaging or formulations It is essential to follow the product manufacturers storage instructions to the maximum extent possible Less stable medicines must be stored in specific conditions to maintain their quality or potency

The following products require special storage facilities

middot Products that must be kept frozen (usually vaccines and sera) middot Products sensitive to h eat an d r e q uir in g r e f r ig e r a tio n ( +2 C to +8 C) middot Products that have reduced shelf life at uncontrolled room temperature and need

mechanical ventilation or air conditioning middot Flammable products that require separate fireproof premises middot Products prone to theft o r m i s u s e

Products needing storage in a controlled environment -

The usable shelf life of the following products may be reduced if stored at uncontrolled humidity or at room temperature in hot climates -

middot Some injectables (eg adrenaline) Most injectable preparations are less stable than solid oral forms (tablets and capsules) Injectable preparations in solution are particularly unstable Many injections must be protected from light as well as heat

middot Intravenous fluids (particularly if packed in p lastic containers) middot Some suppositories pessaries creams and ointments These products may melt at

temperatures greater than 30 C Once this happens it is not advisable to use them because the active ingredient in the formula may get unevenly distributed

middot Products containing rubber latex cellulose or some plastics Condoms most sterile disposable medical devices and surgical products such as syringes needles and catheters require protection from excessive humidity and strong light and heat Any o f these conditions may make products brittle stained amp unusable Sterility cannot be assumed if packaging is damaged

In hot climates these products should be stored in the coolest place possible preferably with air conditioning or air circulation fans

48

Products needing freezing or refrigeration-middot Vaccines blood products and many other medicines lose potency if kept even for a

brief period at temperatures outside the recommended range For these products the cold chain must be maintained at every stage of the distribution system

middot Freezing is as damaging as high temperatures for some products including injectable contraceptives ergometrine insulin adrenaline and the DPT DT TT and Hepatitis B vaccines Such products therefore sho uld not be allowed to freeze (not be kept in the freezer compartment)

middot Short periods at room temperature (during transportation or local distribution for instance) may be acceptable for many products (such as ergometrine a n d i n s u l i n ) e v e n t h o u g h s u c h e x posure can to some extent reduce shelf life Other items such as vaccines should always be transported in cold boxes

Storage of insulin injections-

middot Insulin should always be stored in a refrigerator at the recommended temperature of 2 -8 C

middot Insulin should not be kept in the freezer compartment of the refrigerator middot Insulin should ideally be stored horizontally middot It should not be exposed to sunlight or excessive heat middot Insulin suspensions should not be used if the suspension cannot be properly

resuspended due to cake or clump formationbull

Controlled drugs -Narcotics (for example Pethidine injection morphine preparations) and other specified drugs that may be abused are governed by special legislation and regulations The following security measures are suggested in the pharmacy -middot A safe or reinforced double locked cabinet fitted with a light (preferably with a red

bulb) that comes on when the door is opened

49

middot A special register recording details of each receipt or issue with 2 signatures physi cal counting of medicines after each entry and signatures at handover takeover

middot Independent audit (by supervisors and drug inspectors)

Products prone to theft abuse or misuse -

Some medicinesproducts are particularly prone to theft abuse or misuse These include expensive medicines (eg insulin) certain antibiotics and products prone to abuse or misuse like psychotropics etc

Such medicinesproducts should be stored adequately They require stricter record keeping and more frequent stock taki ng than others Periodic audits should be carried out to check for consumption against actual recorded use (registers prescription records stock records etc) to expose any theft or misuse bull26 Storage and stability of medicines Medicines are not stab le indefinitely They are stable for a specific period of time sometimes for a brief period Poor storage conditions accelerate the drug degradation (decomposition) Temperature light and moisture are the most important contributing factors for drug instability It is important to identify and be aware of the potential for instability There is a need to comply with storage requirements to ensure quality medicines for patients It is also important to offer advice to patients too about appropriate storage o f medicines at home The dispensing label should state the storage condition required and be backed up by a verbal reminder especially where special storage is required bull

50

In case stability and storage problems are seen with formulations they should be reported immediately to the representative of the manufacturer and taken out of circulation till the stability problems have been resolved

The pharmacist can easily detect stability problems when products show change in appearance color odor settling of the product contents breaking of emulsions melting of creams oozing of contents from the containers and any such physical changes

3 STOCK CONTROL AND EXPIRY MONITORING 3 1 S t o c k C o n t r o l For economic reasons pharmacists do not like to have stock on their shelves for long periods of time The aim should always be to keep stock at a level that will just meet demand Normally most manufactured medicines have a long shelf life Even then it is essential that there is efficient stock rot ation so that the older stock is used first It is also a good practice to check the expiry date as an integral part of the dispensing process When short shelf life products are involved stock levels may have to be modified to prevent medicines regularl y expiring on the shelves

32 Stock rotation and expiry monitoring In order to avoid accumulation of expired and obsolete stock medicines should be stored and issued according to the following guidelines -middot The stock control system must record the ex p i r y d a t e a n d t h e d a t e o f r e c e i p t middot Stock must be stored so that earliest expiring batches are picked and issued first middot The First In First Out (FIFO) system - In this system the stock which is received

first is sold first This system however may not be useful for pharmacies because most of the stocks carry an expiry date For pharmacies the FEFO system is more practical

51

middot The First Expiry First Out (FEFO) system - In this system the stock having an earlier expiry is sold first The stock with longer shelf life should be placed farthest to the back (or at the bottom in case o f sta c k e d b oxe s) T h is is pa r tic u la r ly impor ta n t with products that have short shelf lives such as vaccines some vitamins antibiotics etc and reduces losses due to expiry

middot E x p i r y dates should be noted on the stock record upon receipt Stock nearing expiry should not be accepted unless it can be used before expiry

Computerization and expiry monitoring In the pharmacy computerization facilitates both checking stocks and expiry mo nitoring and helps-bullbullKeeping a check on products nearing expiry bullbullKeeping a check on non- moving and slow moving products bullbullTo facilitate the removal of medicines nearing expiry from shelves in time to send them back to the wholesaler or supplier

Periodic checking for expiry The expiry date for medicinal products is a critical aspect in pharmaceutical dispensing and due importance should be given to it Periodic checking for expiry of medicines will ensure that the patient will never receive products that have crossed their expiry date During periodical checking of expiry the personnel involved should remove medicines that are nearing expiry bullbullIn -house threshold periods should be set and followed for retrieval of such medicines from the shelves bullbullSuch medicines should be stored separately These should either be dispensed immediately (thus ensuring that they are used before the expiry date) o r t h e y s h o u l d b e returned to the suppliers bullbullA separate area should be designated (cupboard or shelf)marked[FROZEN ZONE] which is adequately marked EXPIRED GOODS- NOT FOR SALE to store all expired stocks FROZEN ZONE

52

Remember Expired medicines are a NATIONAL WASTE So stock only what you can sell Avoid expiries save precious medicines for the nation

Treatment and disposing of expired medicines bullbullProcedures need to be in place for the treatment of expired medicines bullbullThe expired medicines need to be collected and be sent back to the supplier or company for appropriate disposal bullbullRecords must be maintained for expired medicines and how they are disposed off bullbullIn case of medicines that are not returnable to suppliers procedures for disposal need to be followed by the pharmacy in conjunction with the FDA The following procedure can be followed if medicines cannot be returned to suppliers ( T h e b a s i c p h i l o s o p h y of appropriate disposal is to prevent their re- circulation and use) bullbullC u t t h e c o n t ainer in such a manner that the label is also cut In case of tablets and c a p s u l e s d e s t r o y them by disposing them in a bucket of water bullbullUse landfill procedures (deep burial into the ground as per stipulations of Medical Waste Disposal Act prevalent in the respective state) bullbullPour the liquids into the sink and wash away with sufficient quantity of water bullbullKeep a record of such disposal with full details of medicines destroyed Although these measures are usually adopted care has to be taken with such tr e a t m e n t a s studies have shown that flushing of medicines has resulted in tracessmall quantities of medicines being found in waterways and groundwater having potential health and environmental effects

4 O T H E R A S P E C T S 41 Design of storage areas The following important factors need to be considered in design of storage areas -middot The retail outlets in hot areas in summers should be air-conditioned Similarly in

a r e a s o f e x t r e m e c o l d t h e p r e m i s e s w o u l d r e q u i r e w a r m i n g e s p e c i a l l y i n w i n t e r s t o maintain cool temperatures The placement of air -conditioners and heating devices should be such that medicines are not directly exposed to the cold or heat

middot Due consideration should be given to storage requirements of formulations while designing shelves and cupboards in retail outlets Sufficient shelf height should be provided so that all liquid products can be stored vertically As far as possible the shelves should be covered with glass panels to protect medicines from dust and p r e v e n t r a p i d f l u c t u a t i o n s i n temperature

middot Medicines should be stored according to the storage instructions on the labels bullIt is ideal to have a door at the pharmacy entrance to prevent dust from coming in as well as reduceprevent cooled air from going out This may not however be considered feasiblepracticable by many pharmacy owners for fear that clients may not enter the pharmacy because the door may act as a barrier An air curtain is a good alternative to a door

middot There should be minimal direct sunlight falling on the products Particular consideration should be given to premises directly facing the sun

middot bullThe arrangement of lighting in the interior of the premises should also be in a manner that the lights are not focused on the products It has been shown that light causes not only chemical damage but also can catalyze physical changes like moisture uptak e by the products Care should be taken to ensure that only diffused light falls on them

53

middot As far as possible provision should be made for a temperature and humidity indicator device in a pharmacy These devices are now easily available

middot Stability studies o f m e d i c i n e s p a c k e d i n b l i s t e r s h a v e r e v e a l e d t h a t i f t h e s e a r e exposed to light they tend to absorb moisture It is therefore necessary to store them in suitable cartons so that the blisters are not exposed to light Pharmacists should do this even if the manufacturer has not provided cartons

middot Light and temperature sensitive products should not be stored on counters where the light is intense or direct and there is no protection from temperature and humidity

42 Cleaning and maintenance i) Cleaning of storage areas

The storage areas of the pharmacy should be cleaned periodically and cleanliness should be maintained at all times The Standard Operating Procedure for cleaning should be designed and followed accordingly Schedules for cleanups should be laid down and adequate cleaning equipment should be made available

Tips for maintaining cleanliness middot Provide clean pieces of cloth for wiping at various locations in the pharmacy

Replace with clean cloth at regular intervals middot Keep separate pieces of cloth for floors shelves and medicines middot Use a disinfectant andor soap solution to clean floors middot Ensure removal of dust and prevent accumulation of dirt middot Ensure removal of cobwebs middot Use a vacuum cleaner for cleaning areas not easily reachable middot T a k e c a r e t h at breakages are handled and cleared effectively middot Observe the factors leading to waste generation in the pharmacy and take appropriate

measures to tackle the problem middot Record all cleaning procedures performed and maintain all the documents required

For ex a m p l e -bullbullThe floor of the pharmacy may be swept with a broom and swabbed with soap water every morning bullbullThe floor may be swabbed with a disinfectant every week bullbullThe entire premises including shelves and cupboards may be cleaned with a cloth (to remove dust and to check for medicines approaching expiry date or expired medicines) every three months bullbullAll the steps followed should be r e c o r d e d

The floor shelves drawers have to be cleaned and a check should be kept on dust cobwebs spillages due to breakage etc It is therefore essential to have SOPs for cleaning laying down cleaning frequencies allotting responsibilities and maintaining a daily record in the logbook to document all these activities

54

While cleaning dust settled on dosage forms like bottles tubes etc should be removed Before dispensing the products should also be wiped to remove any dust settled during storage

For refrigerators bullbullDefrosting and cleaning should be done at regular intervals bullbullSwitch off the refrigerator while cleaning bullbullCleaning should be done quickly and stocks put back immediately

i i ) Pest control Pests are a serious problem in India where insects reptiles and rodents (eg cockroaches l i z a r d s r a t s s i l v e r f i s h (Deemak - in Hindi ) etc) may find access to the pharmacy storage areas Insects like ants and borer ants may often attack wood in the pharmacy causing d am ag e to shelves cupboardsPest c ontr o l in a p h a r m a c y c a n b e a d i f f i c u l t t a s k b u t t o avoid possible contamination and physical damage to stock it is necessary to keep pests out of the pharmacy premisesPest control measures should be implemented with proper p r e c a u t i o n s t a k i n g u t m o s t c a r e t o a v o i d contamination of medicines

55

Th e following pest control measures c a n be ta ke n f r om tim e to tim e -bullbullRat bait and traps can be placed at various locations bullbullInsecticutors can be used on a permanent basis bullbullInsecticidal sprays and repellants can be used from time to time

i i i ) Fire precautions

Combustible trash such as cartons boxes and other packing waste must not be allowed to accumulate in the store Waste should be deposited in appropriate waste bins and be d i s p o s e d o f f o n a d a i l y b a s i s

F i re detection and fire fighting equipment must be maintained and regularly inspected The pharmacy personnel should receive adequate training in fire fighting techniques and emergency actionFire prevention measures should include a prominently displayed ldquoNoSmokingrdquo sign careful handling and disposal of combustible waste materials and checking of electrical connections at regular intervals

iv) Security middot Doors shutters of the pharmacy should be strong and be fitted with secure locks middot Counters should be designed so that unauthorized personnelclients do not have

access to areas where prescription medicines are stored Access to such areas should be restricted to the pharmacy staff

middot All the pharmacy staff handling supplies should be accountable for their ac t i o n s

56

middot bullSpecial care must be taken in case of Schedule X and manufactured drugs (under NDPS Act) Such medicines should be kept under lock and key and the key should be kept with the Chief Pharmacist or i n h i s a b s e n c e t h e s e n i o r p h a r m a c i s t

v) Breakagespillage and damaged product Products that have been damagedspoiled during storage and handling spillages and broken glassware should be disposed off according to procedures laid down by the pharmacy Broken and damaged products s h o u l d b e p l a c e d i n a segregated area to be returned to the supplier

vi) Inspection Senior staff should inspect all pharmacy areas regularly The shelves and drawers should b e c h e c k e d d a i l y f o r signs of pests and dust Ceiling and walls should be checked for dirt and cobwebs Stock should be checked on a regular basis for deterioration due to climatic conditions

43 Product recalls Products found to be defective should be quickly recalled (withdrawn from the market) The instructions are generally issued either by the manufacturer or the regulatory agency The level of recall is determined by both the degree of risk and the extent of distribution of the product and in India is mainly directed at the distribution chain

On receiving the details of the defective substandard spurious batchbatches of a medicine to be recalled from the manufacturer or the stockist or the FDA the pharmacy should immediately check if the particular b a t c h i s i n s t o c k a n d i f s o s u s p e n d i t s s a l e immediately

Similarly if the regulatory authority in the country bans a particular medicine or FDC the pharmacy should immediately check and remove all the different brands of that particular medicine under consideration

The details of medicines and their batches to be recalled should be available in the q u a r a n t i n e a r e a w h e r e stocks are received and checked This is to ensure that such medicines do not come into the pharmacy

middot The pharmacy should develop SOPs for recall of medicines middot The pharmacy staff should be immediately informed about such medicines and

the details should be displayed in writing in a prominent place in the pharmacy middot Rapid action helps avoid unnecessary exposure to such medicines once the

problem has been d e t e c t e d middot The progress of the recall procedure in the pharmacy should be monitored every

few days to ensure complete compliance middot All stocks of the recalled products should be stored separately from the saleable

stock These can be stored in the expiry cupboard segregated from the expired goods and be appropriately labeled ldquoRecal l e d G o o d s - Not for Salerdquo

The supplier should be notified and asked to replace defective products middot All the details of the procedures followed should be duly recorded in a Recall

Register maintained specially for the purpose The register should include d etails such as -middot Date of the recall middot Nam e of the product

57

bullbull

middot Details of the product (name of manufacturer batch number expiry date) middot Nu m b er of units purchased sold a n d sto c k in ha nd middot Reason for recall middot Nam e of the supplier to whom produc ts w e r e returned along with the date and quantity middot Name and signature of the designated personnel carrying out the recall procedure and recording details middot Name and signature of the chief pharmacist verifying the recall procedures and recording details 4 4 Returned medicines

Medicines may be returned to the pharmacy by clients due to the following reasons -bull

bullbull Unused medicines bullbull Course not completed bullbull Therapy changed by doctor bullbull Side effects experienced by patient bull

bullbull DamagedDefective medicines bullbull Missing or defaced label bullbull Missing tablets in a stripblister bullbull Leakage in bottles bullbull Leakage in strips bull

bullbull Expired medicines

Appropriate SOPs should be framed and followed for their acceptancerefusal and disposal middot bull For unused medicines returned by clients the p harmacy personnel should verify

that these were purchased from their pharmacy They should then be checked for integrity of the packing the dosage form and the expiry date and verified with the client whether they were stored in appropriate conditions This again is at the discretion of each pharmacy

middot The damageddefective medicines returned to the pharmacy should be taken back and stored separately Existing stock of the same product should be checked for similar defects

middot Expired medicines should be accepted from clients at the discretion of the pharmacist and be immediately shifted to the expired goods cupboard These can be stored segregated from the pharmacys own expired goods and be appropriately labelled ldquoExpired Goods returned by clients- Not For Salerdquo

It is advisable not to accept returned medicines requiring cold chain storage (refrigeration) because it cannot be ensured that the cold chain was maintained when the medicines were in the hands of the patientclient middot Appropriate adjustments in t he stocks should be made for medicines

returnedexchanged to update the inventory middot The medicines should then be returned to the respective shelves middot A lsquoReturned Goodsrsquo register needs to be maintained to record all details of returned

medicines

R egister should include such details as-

58

middot N a m e o f t h e p a t i e n t middot Nam e of the product and quantity r e tu r n e d middot Product details such as the batch number and expiry date middot Condition in which received middot Reason for returning products middot Compensatory measures taken wi t h r e s p e c t t o c l i e n t middot Action taken with respect to product middot Name and signature of the personnel accepting the returned medicines and recording details middot Name and signature of the chief pharmacist verifying the recorded details

What the pharmacist would have learnt from this module The storage of medicines is a critical factor in the distribution cycle bullbull Stocks received by the pharmacy should be quarantined in a separate area and necessary checks s h o u ld be performed to ascertain the qua lity a nd quantity of stocks received bullbull Whatever pattern and means of storage used the products should be stored so as to maintain their potency and integrity bullbull Storage conditions should be monitored and maintained on a regular basis bullbull Optimum stock levels should be maintained and regularly monitored for expiry bullbull The design of storage areas should facilitate appropriate storage of medicines bullbull Cleanliness should be maintained in the pharmacy bullbull Adequate measures should be taken in case of returned medicines and recalled products

Optimum storage of medicines is mandatory whether at the distribution stage at the pharmacy or ultimately within the homes of patients The pharmacist has an important r o l e t o p l a y i n t h e s t o r a g e o f m e d i c i n e s i n m a i n t a i n i n g d r u g p o t ency and efficacy and thus facilitating optimum therapeutic benefits Good Pharmacy Practice - IPA -CDSCO - WHO Appendix I Quality Assurance Templates of letters for use if found not of Standard Quality [Frozen and expired goods ]

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated To Name of the Supplier with address

Sub Not of Standard Quality GoMP-Supply of Drugs and medicines-(Codename) Return of Stocks to the Suppliers-reg(New drug policy 2009) Previous letterinvoice ref Sl No Drug Code Drug name

Manufacturing date Expiry date

Supplier address

B a t c h n o

The above items of PO nodated was drawn by the Drug Inspector (Place) on (______________date) as a statutory sampling and declared ldquoNot of Standard

59

Qualityrdquo on -(______________date) by the Government Analyst for the following reasons

- ldquoThe product sample do not confirm to IP specification for (Drug codename with respect to the content of drugrdquo

- ldquoThe product has already been blacklisted by TNMSC on -(______________date) for the failure of (quantity) of batches of drug codenamerdquo

As per the clause of the te nde r d oc um e nt ldquo I f the sa mple s d o not c onf o r m to statutory standardsthe tenderer will be liable for relevant action under the existing laws and the entire stock in such batch should be taken back by the tenderer within a period of 30 days o f t h e r e c e i p t o f t h e l e t t e r f r o m t h e v e n u e

The stock shall be taken back at the expenses of the tendererthe Procurement Authority have the right to destroy such Not of Standard Quality if the tenderer does not take back the goods within the stipulated time

The Procuring Authority will arrange to destroy the Not of Standard Quality drugs within 90 days after the expiry of 30 days mentioned above without further notice and shall also collect demurrage charges calculated at the rate of 2 per week on the value of the drugs rejected till such destructionrdquo

Hence we regret to inform you that you will have to take back the stocks available of the abovesaid batch at your own cost from the drug stores where you have supplied the above batch

Kindly acknowledge the receipt of this reference at once

P r o c u r e m e n t A u t h o r i t y Seal and Stamp

Copy to Ref No dated

1 ) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated13082010

To

Sub Frozen Drugs-ordered to return to the Suppliers-reg(New drug policy 2009) Previous letterinvoice ref

The following products which were earlier frozen have now been ordered to return to suppliers directly with permission from the State drug Authority In this regard the suppliers have been instructed to take back their failed batch from the drug store of the stores Hence you are now instructed to return the following failed batches to the suppliers by obtaining proper authorization letter and acknowledgements from them

60

Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

Kindly acknowledge the receipt of this reference at once

Procurement Authority Seal and Stamp

Copy to

Ref No dated 2) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated14092010

To

Sub Frozen Drugs-ordered to return to the Suppliers- for issue of gate pass after verification reg(New drug policy 2009) Previous letterinvoice ref

The following products which were earlier frozen have now been released Hence they may be issued Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

Kindly acknowledge the receipt of this reference at once

Procurement Authority Seal and Stamp

Copy to

61

Ref No dated 3) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated

To

Sub Stop instruction-reg(New drug policy 2009) Previous letterinvoice ref

Until further instructions stop issue all the batches of the following item Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

You must intimate the available stock in the stores of the said batch Number to the Procurement Authority immediately Also retrieve quantity if already issued

Procurement Authority Seal and Stamp

Copy to

Ref No dated 4) HOD Procurement Office of

62

Appendix II Material handling in drug stores

Rack approx rates and dimensions

S No

Item Description UOM Approx Rate

1 MEDIUM DUTY RACK SIZE 2900 H X 3090 W X 800 D IN MM (AS PER SPECIFICATION)

Each 2499800

2 MEDIUM DUTY RACK ADD ON UNIT FOR SIZE OF SR NO2

Each 2243100

To locate a Box no 3 Rack no 14 in row3

SAMPLE OF RACK no Bin numbering -------------- S a y R K 1 4 R o w 3 B o x 1 6

SAMPLE LAYOUT of RACKS in a Drug Stores

63

Sample of another warehouse of distribution warehouse system

64

65

Slotted Angle racks with bin cards

66

Plastic Pallets

Plastic pallets ar e l i g h t w e i g h t l o w- c ost and exceed industry standards for strength and durability

NOTE A pallet has bottom deckboards (see sketch) A skid does not have bottom

67

deckboards

Battery Operated Stacker

Electric Stacker Ehh (Manual Push Type) - Manual drive - Lifting electrically with Battery 12 V 88 Ah - For loading and un-loading of trucks - Battery and loading device built - in - Battery charge gauge and charging current gauge Simple and Easy Operation - Lifting and Lowering electrically direct on steering arm - Pulling and pushing through steering arm - Electrically operated relief valve on hydraulic aggregate Safe Operation - Emergency Off Switch - Constant lowering speed - Protection through lowering brake valve - Overload protection through overload brake valve - Load chains covered preventing pinching threat - Electrically interlocking during loading process - Secured battery compartment opens upwardly - Stable buffering of the steering arm in upright position - In accordance with EWG Guidelines 89 240 - In accordance with VBG 12b Prevention of Accidents

Pallet Truck [ Top ]

68

----------------------------------------------------------------------------------------------------------------------------

For Transport Of All Goods On Pallets Safe and Easy Operation - through single hand operation Lifting moving

lowering with steering handle - neutral position of the hydraulic possible - overload pressure relief valve Long Service Life - robust co n s t r u c t i o n

- special hardened axles - hardened chromium plated ram - maintenance free Easy Maneuverability - through rubber steering rollers - nylon fork rollers

A h a n d t r o l l e y

69

Trolley with plastic bins for several items del ivery

70

Digital Weighing balances

Balances amp Scales EF Seriers Precision Electronic Balance

71

1

Ice lined Refrigerators

600 litres refrigrator

72

Walk in cooler

vacuum cleaner

73

Refrigeration middot All cold chain equipment should meet required standards middot Improvement in refrigeration technology has provided frost -free refrigerators

Pharmacists should opt for frost-free refrigerators as they are easy to maintain and protect printed packaging materials Conventional refrigerators may cause water falling from trays below the freezer on medicines stored in the refrigerator thus causing soggy labels

middot bull Frost-free refrigerators also provide separate and large compartments for the freezer portion (required for storing medicines needing sub-z e r o t e m p e r a t u r e ) and the main storage area with separate doors so that opening one door does not disturb the storage temperature in the other compartment

Care should be taken to keep the refrigerator on 24 hours a day It should not be switched off after working hours It is advisable to have an inverter connected to the refrigerator so that the refrigerator re mains working even when there is a power outage

middot The refrigerator door should be closed tightly middot The refrigerator door should not be left open for too long middot Space should be left between medicines stored in a refrigerator to allow air to

circulate middot The ref rigerator should be placed about an arms length away from the wall

This will increase air circulation thus not affecting the cooling within the refrigerator

middot Vaccines should not be stored on refrigerator door shelves as they are exposed to warmer temperatures each time the door is opened Vaccines should always be stored on the middle shelves of the refrigerator

middot Refrigerated medicines should not be left out of the refrigerator for more than a few minutes

43

middot Consumable products like juices energy drinks e t c s h o u l d n o t b e s t o r e d a l o n g with medicines in refrigerators If required they may be kept in a separate refrigerator

middot An adequate number of refrigerators should be planned to store the entire stocks requiring refrigerated storage

middot Adequate procedures should be followed for defrosting cleaning and maintenance of refrigerators

middot Icefreeze packs should be kept in the freezer compartment so that they can be used for transporting cold temperature medicines The packs can be given to clients along with the medicines requiring cold temperature storage so that the temperature is maintained till the client reaches home and can then put the medicines in a refrigerator) Freezer packs can also be used to keep medicines temporarily in case there is a power outage or refrigerator breakdown

Activity

Prepare a SOP (Standard operating procedure chart) for cleaning a refrigerator Discuss it with your staff finalize its maintenance once a month through AMC -A n n u a l Maintenance contract CMC - Comprehensive maintenance contract and put it up on the pharmacy refrigerator Put the Purchase Order details name of manufacturer Phone of Service Engineer and a register to login the Machine service and down timeService reports may be maintained properly

Refrigerator monitoring and maintenance

middot bullIt is important to carry out routine monitoring and maintenance of the refrigerators and to organize an effective repair system

middot bullThe temperature in the refrigerator must be monitored and recorded routinely at least once a day

middot Any breakdown must be reco rded including the period during which the medicines were exposed to uncontrolled temperatures Medicines may then be kept or discarded depending on the problem guidelines or the manufacturers advice

middot Cold chain monitor cards and devices in or on packages that change color or otherwise alert staff to potential damage assist in monitoring (These are likely to be introduced in India soon)

middot It is essential to have a contingency plan in place before a refrigerator breaks down An arrangement can be made to move the contents to a private refrigerator elsewhere in the community or to obtain a regular supply of ice packs until the defect is rectified

Put filled water bottles in the bottom half of the refrigerator door in order to provide cooling in the refri g e r a t o r w h e n t h e r e i s a p o w e r o u t a g e T h i s m i g h t t a k e c a r e o f t h e temperature when there is no current for a couple of hours If the power outage is expected to last for several hours special arrangements such as an inverter UPS have to be made to keep the refrigerator constantly running in the absence of electricity middot Defrost the refrigerator in case of excessive ice formation and preferably at regular

intervals Keep a record of the same

44

2 4 T e m p e r a t u r e c l i m a t i c c o n d i t i o n s

i) Temperature control middot The medicines in a pharmacy need to be stored at appropriate temperatures to

maintain their stability middot An air-conditioned environment where temperature can be controlled is

recommended for pharmacies Air conditioning offers the option of setting the t e m p e rature as per requirements

middot bullIt is ideal to have an air conditioner to maintain the temperature below 25 C as most medicines require storage below this temperature Secondly this temperature is pleasing to both the staff and the visiting customers too

middot In the absence of an air conditioner circulating fans may be used middot This need is felt even more in certain parts of India where temperatures soar above 45

C and some areas where it falls to sub zero temperatures In such cases temperature maintenance is essential to prevent deterioration of medicines due to unnecessary exposure to drastic temperature fluctuations

middot This need is felt even more in certain parts of India where temperatures soar above 45 C and some areas where it falls to sub zero temperat u r e s I n s u c h c a s e s temperature maintenance is essential to prevent deterioration of medicines due to unnecessary exposure to drastic temperature fluctuations

i i ) Humidity or moisture control Moisture or humidity can adversely affect the stability of me dicines such as tablets capsules powders

45

Gelatin capsules become soft and swell on absorption of moisture The drug content of tablets may undergo surface hydrolysis The presence of moisture may encourage the growth of microbes It is therefore essential to control humidity

To reduce the effect of humidity the following suggestions may be followed -middot Open the windows to allow air circulation Use a fan to circulate fresh (outside) air middot In humid climate a dehumidifier is useful for preventing mo i s t u r e d a m a g e ( i n t h e absence of an air conditioner) middot For bulk containers of tabletscapsules do not keep the container open for a long time and replace the lid or closure immediately after taking out the required number of medicines for dispensing middot Do not allow the medicines to touch the floor or the walls The walls may be damp and may cause moisture absorption damaging the product

middot Calibrated thermometers and manometers can be used to detect temperature and humidity in the pharmacy

middot Periodici t y of checking the temperature should be fixed middot The climatic conditions should be recorded and documented middot Temperature charts should be available for ready reference

Documentation is one of the core activities for achieving and maintaining quality It is one of the most essential components of validation Temperatures in various areas

46

including refrigerators should be recorded at a predetermined periodicity usually daily at the hottest time of the day and such documents should be preserved i i i ) Storage conditions A number of storage conditions are mentioned on the labels of medicinal products These conditions have to be properly interpreted and appropriately complied with

According to the Drugs and Cosmetics Rules 1945

1 The term cool place means a place having a temperature between 10 C and 25 C

2 The term cold place means a place having a temperature not exceeding 8 C In case of storage conditions for specific products please refer to Schedule P The Drugs and Cosmetic Rules 1 9 4 5

The Indian Pharmacopoeia specifies the following storage conditions -

Wherever the condition for storage is not specified medicines may be stored under normal temperature In a country like India however where normal temperatures soar to h i gh temperatures it is recommended that medicines be stored in a cool place

Activity Prepare a list of the storage requirements mentioned on the label of about 20 products in your pharmacy and check if the temperature is maintained

47

25 Special Storage o f s u p p l i e s If the product has no special instructions normal storage conditions apply This means storage in dry clean w e l l -ventilated premises at temperatures of +15 C to +25 C or depending on the climate up to +30 C (WHO1990) Storage instructions are product specific Different brands of the same generic drug may have different storage requirements as they may have different packaging or formulations It is essential to follow the product manufacturers storage instructions to the maximum extent possible Less stable medicines must be stored in specific conditions to maintain their quality or potency

The following products require special storage facilities

middot Products that must be kept frozen (usually vaccines and sera) middot Products sensitive to h eat an d r e q uir in g r e f r ig e r a tio n ( +2 C to +8 C) middot Products that have reduced shelf life at uncontrolled room temperature and need

mechanical ventilation or air conditioning middot Flammable products that require separate fireproof premises middot Products prone to theft o r m i s u s e

Products needing storage in a controlled environment -

The usable shelf life of the following products may be reduced if stored at uncontrolled humidity or at room temperature in hot climates -

middot Some injectables (eg adrenaline) Most injectable preparations are less stable than solid oral forms (tablets and capsules) Injectable preparations in solution are particularly unstable Many injections must be protected from light as well as heat

middot Intravenous fluids (particularly if packed in p lastic containers) middot Some suppositories pessaries creams and ointments These products may melt at

temperatures greater than 30 C Once this happens it is not advisable to use them because the active ingredient in the formula may get unevenly distributed

middot Products containing rubber latex cellulose or some plastics Condoms most sterile disposable medical devices and surgical products such as syringes needles and catheters require protection from excessive humidity and strong light and heat Any o f these conditions may make products brittle stained amp unusable Sterility cannot be assumed if packaging is damaged

In hot climates these products should be stored in the coolest place possible preferably with air conditioning or air circulation fans

48

Products needing freezing or refrigeration-middot Vaccines blood products and many other medicines lose potency if kept even for a

brief period at temperatures outside the recommended range For these products the cold chain must be maintained at every stage of the distribution system

middot Freezing is as damaging as high temperatures for some products including injectable contraceptives ergometrine insulin adrenaline and the DPT DT TT and Hepatitis B vaccines Such products therefore sho uld not be allowed to freeze (not be kept in the freezer compartment)

middot Short periods at room temperature (during transportation or local distribution for instance) may be acceptable for many products (such as ergometrine a n d i n s u l i n ) e v e n t h o u g h s u c h e x posure can to some extent reduce shelf life Other items such as vaccines should always be transported in cold boxes

Storage of insulin injections-

middot Insulin should always be stored in a refrigerator at the recommended temperature of 2 -8 C

middot Insulin should not be kept in the freezer compartment of the refrigerator middot Insulin should ideally be stored horizontally middot It should not be exposed to sunlight or excessive heat middot Insulin suspensions should not be used if the suspension cannot be properly

resuspended due to cake or clump formationbull

Controlled drugs -Narcotics (for example Pethidine injection morphine preparations) and other specified drugs that may be abused are governed by special legislation and regulations The following security measures are suggested in the pharmacy -middot A safe or reinforced double locked cabinet fitted with a light (preferably with a red

bulb) that comes on when the door is opened

49

middot A special register recording details of each receipt or issue with 2 signatures physi cal counting of medicines after each entry and signatures at handover takeover

middot Independent audit (by supervisors and drug inspectors)

Products prone to theft abuse or misuse -

Some medicinesproducts are particularly prone to theft abuse or misuse These include expensive medicines (eg insulin) certain antibiotics and products prone to abuse or misuse like psychotropics etc

Such medicinesproducts should be stored adequately They require stricter record keeping and more frequent stock taki ng than others Periodic audits should be carried out to check for consumption against actual recorded use (registers prescription records stock records etc) to expose any theft or misuse bull26 Storage and stability of medicines Medicines are not stab le indefinitely They are stable for a specific period of time sometimes for a brief period Poor storage conditions accelerate the drug degradation (decomposition) Temperature light and moisture are the most important contributing factors for drug instability It is important to identify and be aware of the potential for instability There is a need to comply with storage requirements to ensure quality medicines for patients It is also important to offer advice to patients too about appropriate storage o f medicines at home The dispensing label should state the storage condition required and be backed up by a verbal reminder especially where special storage is required bull

50

In case stability and storage problems are seen with formulations they should be reported immediately to the representative of the manufacturer and taken out of circulation till the stability problems have been resolved

The pharmacist can easily detect stability problems when products show change in appearance color odor settling of the product contents breaking of emulsions melting of creams oozing of contents from the containers and any such physical changes

3 STOCK CONTROL AND EXPIRY MONITORING 3 1 S t o c k C o n t r o l For economic reasons pharmacists do not like to have stock on their shelves for long periods of time The aim should always be to keep stock at a level that will just meet demand Normally most manufactured medicines have a long shelf life Even then it is essential that there is efficient stock rot ation so that the older stock is used first It is also a good practice to check the expiry date as an integral part of the dispensing process When short shelf life products are involved stock levels may have to be modified to prevent medicines regularl y expiring on the shelves

32 Stock rotation and expiry monitoring In order to avoid accumulation of expired and obsolete stock medicines should be stored and issued according to the following guidelines -middot The stock control system must record the ex p i r y d a t e a n d t h e d a t e o f r e c e i p t middot Stock must be stored so that earliest expiring batches are picked and issued first middot The First In First Out (FIFO) system - In this system the stock which is received

first is sold first This system however may not be useful for pharmacies because most of the stocks carry an expiry date For pharmacies the FEFO system is more practical

51

middot The First Expiry First Out (FEFO) system - In this system the stock having an earlier expiry is sold first The stock with longer shelf life should be placed farthest to the back (or at the bottom in case o f sta c k e d b oxe s) T h is is pa r tic u la r ly impor ta n t with products that have short shelf lives such as vaccines some vitamins antibiotics etc and reduces losses due to expiry

middot E x p i r y dates should be noted on the stock record upon receipt Stock nearing expiry should not be accepted unless it can be used before expiry

Computerization and expiry monitoring In the pharmacy computerization facilitates both checking stocks and expiry mo nitoring and helps-bullbullKeeping a check on products nearing expiry bullbullKeeping a check on non- moving and slow moving products bullbullTo facilitate the removal of medicines nearing expiry from shelves in time to send them back to the wholesaler or supplier

Periodic checking for expiry The expiry date for medicinal products is a critical aspect in pharmaceutical dispensing and due importance should be given to it Periodic checking for expiry of medicines will ensure that the patient will never receive products that have crossed their expiry date During periodical checking of expiry the personnel involved should remove medicines that are nearing expiry bullbullIn -house threshold periods should be set and followed for retrieval of such medicines from the shelves bullbullSuch medicines should be stored separately These should either be dispensed immediately (thus ensuring that they are used before the expiry date) o r t h e y s h o u l d b e returned to the suppliers bullbullA separate area should be designated (cupboard or shelf)marked[FROZEN ZONE] which is adequately marked EXPIRED GOODS- NOT FOR SALE to store all expired stocks FROZEN ZONE

52

Remember Expired medicines are a NATIONAL WASTE So stock only what you can sell Avoid expiries save precious medicines for the nation

Treatment and disposing of expired medicines bullbullProcedures need to be in place for the treatment of expired medicines bullbullThe expired medicines need to be collected and be sent back to the supplier or company for appropriate disposal bullbullRecords must be maintained for expired medicines and how they are disposed off bullbullIn case of medicines that are not returnable to suppliers procedures for disposal need to be followed by the pharmacy in conjunction with the FDA The following procedure can be followed if medicines cannot be returned to suppliers ( T h e b a s i c p h i l o s o p h y of appropriate disposal is to prevent their re- circulation and use) bullbullC u t t h e c o n t ainer in such a manner that the label is also cut In case of tablets and c a p s u l e s d e s t r o y them by disposing them in a bucket of water bullbullUse landfill procedures (deep burial into the ground as per stipulations of Medical Waste Disposal Act prevalent in the respective state) bullbullPour the liquids into the sink and wash away with sufficient quantity of water bullbullKeep a record of such disposal with full details of medicines destroyed Although these measures are usually adopted care has to be taken with such tr e a t m e n t a s studies have shown that flushing of medicines has resulted in tracessmall quantities of medicines being found in waterways and groundwater having potential health and environmental effects

4 O T H E R A S P E C T S 41 Design of storage areas The following important factors need to be considered in design of storage areas -middot The retail outlets in hot areas in summers should be air-conditioned Similarly in

a r e a s o f e x t r e m e c o l d t h e p r e m i s e s w o u l d r e q u i r e w a r m i n g e s p e c i a l l y i n w i n t e r s t o maintain cool temperatures The placement of air -conditioners and heating devices should be such that medicines are not directly exposed to the cold or heat

middot Due consideration should be given to storage requirements of formulations while designing shelves and cupboards in retail outlets Sufficient shelf height should be provided so that all liquid products can be stored vertically As far as possible the shelves should be covered with glass panels to protect medicines from dust and p r e v e n t r a p i d f l u c t u a t i o n s i n temperature

middot Medicines should be stored according to the storage instructions on the labels bullIt is ideal to have a door at the pharmacy entrance to prevent dust from coming in as well as reduceprevent cooled air from going out This may not however be considered feasiblepracticable by many pharmacy owners for fear that clients may not enter the pharmacy because the door may act as a barrier An air curtain is a good alternative to a door

middot There should be minimal direct sunlight falling on the products Particular consideration should be given to premises directly facing the sun

middot bullThe arrangement of lighting in the interior of the premises should also be in a manner that the lights are not focused on the products It has been shown that light causes not only chemical damage but also can catalyze physical changes like moisture uptak e by the products Care should be taken to ensure that only diffused light falls on them

53

middot As far as possible provision should be made for a temperature and humidity indicator device in a pharmacy These devices are now easily available

middot Stability studies o f m e d i c i n e s p a c k e d i n b l i s t e r s h a v e r e v e a l e d t h a t i f t h e s e a r e exposed to light they tend to absorb moisture It is therefore necessary to store them in suitable cartons so that the blisters are not exposed to light Pharmacists should do this even if the manufacturer has not provided cartons

middot Light and temperature sensitive products should not be stored on counters where the light is intense or direct and there is no protection from temperature and humidity

42 Cleaning and maintenance i) Cleaning of storage areas

The storage areas of the pharmacy should be cleaned periodically and cleanliness should be maintained at all times The Standard Operating Procedure for cleaning should be designed and followed accordingly Schedules for cleanups should be laid down and adequate cleaning equipment should be made available

Tips for maintaining cleanliness middot Provide clean pieces of cloth for wiping at various locations in the pharmacy

Replace with clean cloth at regular intervals middot Keep separate pieces of cloth for floors shelves and medicines middot Use a disinfectant andor soap solution to clean floors middot Ensure removal of dust and prevent accumulation of dirt middot Ensure removal of cobwebs middot Use a vacuum cleaner for cleaning areas not easily reachable middot T a k e c a r e t h at breakages are handled and cleared effectively middot Observe the factors leading to waste generation in the pharmacy and take appropriate

measures to tackle the problem middot Record all cleaning procedures performed and maintain all the documents required

For ex a m p l e -bullbullThe floor of the pharmacy may be swept with a broom and swabbed with soap water every morning bullbullThe floor may be swabbed with a disinfectant every week bullbullThe entire premises including shelves and cupboards may be cleaned with a cloth (to remove dust and to check for medicines approaching expiry date or expired medicines) every three months bullbullAll the steps followed should be r e c o r d e d

The floor shelves drawers have to be cleaned and a check should be kept on dust cobwebs spillages due to breakage etc It is therefore essential to have SOPs for cleaning laying down cleaning frequencies allotting responsibilities and maintaining a daily record in the logbook to document all these activities

54

While cleaning dust settled on dosage forms like bottles tubes etc should be removed Before dispensing the products should also be wiped to remove any dust settled during storage

For refrigerators bullbullDefrosting and cleaning should be done at regular intervals bullbullSwitch off the refrigerator while cleaning bullbullCleaning should be done quickly and stocks put back immediately

i i ) Pest control Pests are a serious problem in India where insects reptiles and rodents (eg cockroaches l i z a r d s r a t s s i l v e r f i s h (Deemak - in Hindi ) etc) may find access to the pharmacy storage areas Insects like ants and borer ants may often attack wood in the pharmacy causing d am ag e to shelves cupboardsPest c ontr o l in a p h a r m a c y c a n b e a d i f f i c u l t t a s k b u t t o avoid possible contamination and physical damage to stock it is necessary to keep pests out of the pharmacy premisesPest control measures should be implemented with proper p r e c a u t i o n s t a k i n g u t m o s t c a r e t o a v o i d contamination of medicines

55

Th e following pest control measures c a n be ta ke n f r om tim e to tim e -bullbullRat bait and traps can be placed at various locations bullbullInsecticutors can be used on a permanent basis bullbullInsecticidal sprays and repellants can be used from time to time

i i i ) Fire precautions

Combustible trash such as cartons boxes and other packing waste must not be allowed to accumulate in the store Waste should be deposited in appropriate waste bins and be d i s p o s e d o f f o n a d a i l y b a s i s

F i re detection and fire fighting equipment must be maintained and regularly inspected The pharmacy personnel should receive adequate training in fire fighting techniques and emergency actionFire prevention measures should include a prominently displayed ldquoNoSmokingrdquo sign careful handling and disposal of combustible waste materials and checking of electrical connections at regular intervals

iv) Security middot Doors shutters of the pharmacy should be strong and be fitted with secure locks middot Counters should be designed so that unauthorized personnelclients do not have

access to areas where prescription medicines are stored Access to such areas should be restricted to the pharmacy staff

middot All the pharmacy staff handling supplies should be accountable for their ac t i o n s

56

middot bullSpecial care must be taken in case of Schedule X and manufactured drugs (under NDPS Act) Such medicines should be kept under lock and key and the key should be kept with the Chief Pharmacist or i n h i s a b s e n c e t h e s e n i o r p h a r m a c i s t

v) Breakagespillage and damaged product Products that have been damagedspoiled during storage and handling spillages and broken glassware should be disposed off according to procedures laid down by the pharmacy Broken and damaged products s h o u l d b e p l a c e d i n a segregated area to be returned to the supplier

vi) Inspection Senior staff should inspect all pharmacy areas regularly The shelves and drawers should b e c h e c k e d d a i l y f o r signs of pests and dust Ceiling and walls should be checked for dirt and cobwebs Stock should be checked on a regular basis for deterioration due to climatic conditions

43 Product recalls Products found to be defective should be quickly recalled (withdrawn from the market) The instructions are generally issued either by the manufacturer or the regulatory agency The level of recall is determined by both the degree of risk and the extent of distribution of the product and in India is mainly directed at the distribution chain

On receiving the details of the defective substandard spurious batchbatches of a medicine to be recalled from the manufacturer or the stockist or the FDA the pharmacy should immediately check if the particular b a t c h i s i n s t o c k a n d i f s o s u s p e n d i t s s a l e immediately

Similarly if the regulatory authority in the country bans a particular medicine or FDC the pharmacy should immediately check and remove all the different brands of that particular medicine under consideration

The details of medicines and their batches to be recalled should be available in the q u a r a n t i n e a r e a w h e r e stocks are received and checked This is to ensure that such medicines do not come into the pharmacy

middot The pharmacy should develop SOPs for recall of medicines middot The pharmacy staff should be immediately informed about such medicines and

the details should be displayed in writing in a prominent place in the pharmacy middot Rapid action helps avoid unnecessary exposure to such medicines once the

problem has been d e t e c t e d middot The progress of the recall procedure in the pharmacy should be monitored every

few days to ensure complete compliance middot All stocks of the recalled products should be stored separately from the saleable

stock These can be stored in the expiry cupboard segregated from the expired goods and be appropriately labeled ldquoRecal l e d G o o d s - Not for Salerdquo

The supplier should be notified and asked to replace defective products middot All the details of the procedures followed should be duly recorded in a Recall

Register maintained specially for the purpose The register should include d etails such as -middot Date of the recall middot Nam e of the product

57

bullbull

middot Details of the product (name of manufacturer batch number expiry date) middot Nu m b er of units purchased sold a n d sto c k in ha nd middot Reason for recall middot Nam e of the supplier to whom produc ts w e r e returned along with the date and quantity middot Name and signature of the designated personnel carrying out the recall procedure and recording details middot Name and signature of the chief pharmacist verifying the recall procedures and recording details 4 4 Returned medicines

Medicines may be returned to the pharmacy by clients due to the following reasons -bull

bullbull Unused medicines bullbull Course not completed bullbull Therapy changed by doctor bullbull Side effects experienced by patient bull

bullbull DamagedDefective medicines bullbull Missing or defaced label bullbull Missing tablets in a stripblister bullbull Leakage in bottles bullbull Leakage in strips bull

bullbull Expired medicines

Appropriate SOPs should be framed and followed for their acceptancerefusal and disposal middot bull For unused medicines returned by clients the p harmacy personnel should verify

that these were purchased from their pharmacy They should then be checked for integrity of the packing the dosage form and the expiry date and verified with the client whether they were stored in appropriate conditions This again is at the discretion of each pharmacy

middot The damageddefective medicines returned to the pharmacy should be taken back and stored separately Existing stock of the same product should be checked for similar defects

middot Expired medicines should be accepted from clients at the discretion of the pharmacist and be immediately shifted to the expired goods cupboard These can be stored segregated from the pharmacys own expired goods and be appropriately labelled ldquoExpired Goods returned by clients- Not For Salerdquo

It is advisable not to accept returned medicines requiring cold chain storage (refrigeration) because it cannot be ensured that the cold chain was maintained when the medicines were in the hands of the patientclient middot Appropriate adjustments in t he stocks should be made for medicines

returnedexchanged to update the inventory middot The medicines should then be returned to the respective shelves middot A lsquoReturned Goodsrsquo register needs to be maintained to record all details of returned

medicines

R egister should include such details as-

58

middot N a m e o f t h e p a t i e n t middot Nam e of the product and quantity r e tu r n e d middot Product details such as the batch number and expiry date middot Condition in which received middot Reason for returning products middot Compensatory measures taken wi t h r e s p e c t t o c l i e n t middot Action taken with respect to product middot Name and signature of the personnel accepting the returned medicines and recording details middot Name and signature of the chief pharmacist verifying the recorded details

What the pharmacist would have learnt from this module The storage of medicines is a critical factor in the distribution cycle bullbull Stocks received by the pharmacy should be quarantined in a separate area and necessary checks s h o u ld be performed to ascertain the qua lity a nd quantity of stocks received bullbull Whatever pattern and means of storage used the products should be stored so as to maintain their potency and integrity bullbull Storage conditions should be monitored and maintained on a regular basis bullbull Optimum stock levels should be maintained and regularly monitored for expiry bullbull The design of storage areas should facilitate appropriate storage of medicines bullbull Cleanliness should be maintained in the pharmacy bullbull Adequate measures should be taken in case of returned medicines and recalled products

Optimum storage of medicines is mandatory whether at the distribution stage at the pharmacy or ultimately within the homes of patients The pharmacist has an important r o l e t o p l a y i n t h e s t o r a g e o f m e d i c i n e s i n m a i n t a i n i n g d r u g p o t ency and efficacy and thus facilitating optimum therapeutic benefits Good Pharmacy Practice - IPA -CDSCO - WHO Appendix I Quality Assurance Templates of letters for use if found not of Standard Quality [Frozen and expired goods ]

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated To Name of the Supplier with address

Sub Not of Standard Quality GoMP-Supply of Drugs and medicines-(Codename) Return of Stocks to the Suppliers-reg(New drug policy 2009) Previous letterinvoice ref Sl No Drug Code Drug name

Manufacturing date Expiry date

Supplier address

B a t c h n o

The above items of PO nodated was drawn by the Drug Inspector (Place) on (______________date) as a statutory sampling and declared ldquoNot of Standard

59

Qualityrdquo on -(______________date) by the Government Analyst for the following reasons

- ldquoThe product sample do not confirm to IP specification for (Drug codename with respect to the content of drugrdquo

- ldquoThe product has already been blacklisted by TNMSC on -(______________date) for the failure of (quantity) of batches of drug codenamerdquo

As per the clause of the te nde r d oc um e nt ldquo I f the sa mple s d o not c onf o r m to statutory standardsthe tenderer will be liable for relevant action under the existing laws and the entire stock in such batch should be taken back by the tenderer within a period of 30 days o f t h e r e c e i p t o f t h e l e t t e r f r o m t h e v e n u e

The stock shall be taken back at the expenses of the tendererthe Procurement Authority have the right to destroy such Not of Standard Quality if the tenderer does not take back the goods within the stipulated time

The Procuring Authority will arrange to destroy the Not of Standard Quality drugs within 90 days after the expiry of 30 days mentioned above without further notice and shall also collect demurrage charges calculated at the rate of 2 per week on the value of the drugs rejected till such destructionrdquo

Hence we regret to inform you that you will have to take back the stocks available of the abovesaid batch at your own cost from the drug stores where you have supplied the above batch

Kindly acknowledge the receipt of this reference at once

P r o c u r e m e n t A u t h o r i t y Seal and Stamp

Copy to Ref No dated

1 ) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated13082010

To

Sub Frozen Drugs-ordered to return to the Suppliers-reg(New drug policy 2009) Previous letterinvoice ref

The following products which were earlier frozen have now been ordered to return to suppliers directly with permission from the State drug Authority In this regard the suppliers have been instructed to take back their failed batch from the drug store of the stores Hence you are now instructed to return the following failed batches to the suppliers by obtaining proper authorization letter and acknowledgements from them

60

Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

Kindly acknowledge the receipt of this reference at once

Procurement Authority Seal and Stamp

Copy to

Ref No dated 2) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated14092010

To

Sub Frozen Drugs-ordered to return to the Suppliers- for issue of gate pass after verification reg(New drug policy 2009) Previous letterinvoice ref

The following products which were earlier frozen have now been released Hence they may be issued Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

Kindly acknowledge the receipt of this reference at once

Procurement Authority Seal and Stamp

Copy to

61

Ref No dated 3) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated

To

Sub Stop instruction-reg(New drug policy 2009) Previous letterinvoice ref

Until further instructions stop issue all the batches of the following item Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

You must intimate the available stock in the stores of the said batch Number to the Procurement Authority immediately Also retrieve quantity if already issued

Procurement Authority Seal and Stamp

Copy to

Ref No dated 4) HOD Procurement Office of

62

Appendix II Material handling in drug stores

Rack approx rates and dimensions

S No

Item Description UOM Approx Rate

1 MEDIUM DUTY RACK SIZE 2900 H X 3090 W X 800 D IN MM (AS PER SPECIFICATION)

Each 2499800

2 MEDIUM DUTY RACK ADD ON UNIT FOR SIZE OF SR NO2

Each 2243100

To locate a Box no 3 Rack no 14 in row3

SAMPLE OF RACK no Bin numbering -------------- S a y R K 1 4 R o w 3 B o x 1 6

SAMPLE LAYOUT of RACKS in a Drug Stores

63

Sample of another warehouse of distribution warehouse system

64

65

Slotted Angle racks with bin cards

66

Plastic Pallets

Plastic pallets ar e l i g h t w e i g h t l o w- c ost and exceed industry standards for strength and durability

NOTE A pallet has bottom deckboards (see sketch) A skid does not have bottom

67

deckboards

Battery Operated Stacker

Electric Stacker Ehh (Manual Push Type) - Manual drive - Lifting electrically with Battery 12 V 88 Ah - For loading and un-loading of trucks - Battery and loading device built - in - Battery charge gauge and charging current gauge Simple and Easy Operation - Lifting and Lowering electrically direct on steering arm - Pulling and pushing through steering arm - Electrically operated relief valve on hydraulic aggregate Safe Operation - Emergency Off Switch - Constant lowering speed - Protection through lowering brake valve - Overload protection through overload brake valve - Load chains covered preventing pinching threat - Electrically interlocking during loading process - Secured battery compartment opens upwardly - Stable buffering of the steering arm in upright position - In accordance with EWG Guidelines 89 240 - In accordance with VBG 12b Prevention of Accidents

Pallet Truck [ Top ]

68

----------------------------------------------------------------------------------------------------------------------------

For Transport Of All Goods On Pallets Safe and Easy Operation - through single hand operation Lifting moving

lowering with steering handle - neutral position of the hydraulic possible - overload pressure relief valve Long Service Life - robust co n s t r u c t i o n

- special hardened axles - hardened chromium plated ram - maintenance free Easy Maneuverability - through rubber steering rollers - nylon fork rollers

A h a n d t r o l l e y

69

Trolley with plastic bins for several items del ivery

70

Digital Weighing balances

Balances amp Scales EF Seriers Precision Electronic Balance

71

1

Ice lined Refrigerators

600 litres refrigrator

72

Walk in cooler

vacuum cleaner

73

middot Consumable products like juices energy drinks e t c s h o u l d n o t b e s t o r e d a l o n g with medicines in refrigerators If required they may be kept in a separate refrigerator

middot An adequate number of refrigerators should be planned to store the entire stocks requiring refrigerated storage

middot Adequate procedures should be followed for defrosting cleaning and maintenance of refrigerators

middot Icefreeze packs should be kept in the freezer compartment so that they can be used for transporting cold temperature medicines The packs can be given to clients along with the medicines requiring cold temperature storage so that the temperature is maintained till the client reaches home and can then put the medicines in a refrigerator) Freezer packs can also be used to keep medicines temporarily in case there is a power outage or refrigerator breakdown

Activity

Prepare a SOP (Standard operating procedure chart) for cleaning a refrigerator Discuss it with your staff finalize its maintenance once a month through AMC -A n n u a l Maintenance contract CMC - Comprehensive maintenance contract and put it up on the pharmacy refrigerator Put the Purchase Order details name of manufacturer Phone of Service Engineer and a register to login the Machine service and down timeService reports may be maintained properly

Refrigerator monitoring and maintenance

middot bullIt is important to carry out routine monitoring and maintenance of the refrigerators and to organize an effective repair system

middot bullThe temperature in the refrigerator must be monitored and recorded routinely at least once a day

middot Any breakdown must be reco rded including the period during which the medicines were exposed to uncontrolled temperatures Medicines may then be kept or discarded depending on the problem guidelines or the manufacturers advice

middot Cold chain monitor cards and devices in or on packages that change color or otherwise alert staff to potential damage assist in monitoring (These are likely to be introduced in India soon)

middot It is essential to have a contingency plan in place before a refrigerator breaks down An arrangement can be made to move the contents to a private refrigerator elsewhere in the community or to obtain a regular supply of ice packs until the defect is rectified

Put filled water bottles in the bottom half of the refrigerator door in order to provide cooling in the refri g e r a t o r w h e n t h e r e i s a p o w e r o u t a g e T h i s m i g h t t a k e c a r e o f t h e temperature when there is no current for a couple of hours If the power outage is expected to last for several hours special arrangements such as an inverter UPS have to be made to keep the refrigerator constantly running in the absence of electricity middot Defrost the refrigerator in case of excessive ice formation and preferably at regular

intervals Keep a record of the same

44

2 4 T e m p e r a t u r e c l i m a t i c c o n d i t i o n s

i) Temperature control middot The medicines in a pharmacy need to be stored at appropriate temperatures to

maintain their stability middot An air-conditioned environment where temperature can be controlled is

recommended for pharmacies Air conditioning offers the option of setting the t e m p e rature as per requirements

middot bullIt is ideal to have an air conditioner to maintain the temperature below 25 C as most medicines require storage below this temperature Secondly this temperature is pleasing to both the staff and the visiting customers too

middot In the absence of an air conditioner circulating fans may be used middot This need is felt even more in certain parts of India where temperatures soar above 45

C and some areas where it falls to sub zero temperatures In such cases temperature maintenance is essential to prevent deterioration of medicines due to unnecessary exposure to drastic temperature fluctuations

middot This need is felt even more in certain parts of India where temperatures soar above 45 C and some areas where it falls to sub zero temperat u r e s I n s u c h c a s e s temperature maintenance is essential to prevent deterioration of medicines due to unnecessary exposure to drastic temperature fluctuations

i i ) Humidity or moisture control Moisture or humidity can adversely affect the stability of me dicines such as tablets capsules powders

45

Gelatin capsules become soft and swell on absorption of moisture The drug content of tablets may undergo surface hydrolysis The presence of moisture may encourage the growth of microbes It is therefore essential to control humidity

To reduce the effect of humidity the following suggestions may be followed -middot Open the windows to allow air circulation Use a fan to circulate fresh (outside) air middot In humid climate a dehumidifier is useful for preventing mo i s t u r e d a m a g e ( i n t h e absence of an air conditioner) middot For bulk containers of tabletscapsules do not keep the container open for a long time and replace the lid or closure immediately after taking out the required number of medicines for dispensing middot Do not allow the medicines to touch the floor or the walls The walls may be damp and may cause moisture absorption damaging the product

middot Calibrated thermometers and manometers can be used to detect temperature and humidity in the pharmacy

middot Periodici t y of checking the temperature should be fixed middot The climatic conditions should be recorded and documented middot Temperature charts should be available for ready reference

Documentation is one of the core activities for achieving and maintaining quality It is one of the most essential components of validation Temperatures in various areas

46

including refrigerators should be recorded at a predetermined periodicity usually daily at the hottest time of the day and such documents should be preserved i i i ) Storage conditions A number of storage conditions are mentioned on the labels of medicinal products These conditions have to be properly interpreted and appropriately complied with

According to the Drugs and Cosmetics Rules 1945

1 The term cool place means a place having a temperature between 10 C and 25 C

2 The term cold place means a place having a temperature not exceeding 8 C In case of storage conditions for specific products please refer to Schedule P The Drugs and Cosmetic Rules 1 9 4 5

The Indian Pharmacopoeia specifies the following storage conditions -

Wherever the condition for storage is not specified medicines may be stored under normal temperature In a country like India however where normal temperatures soar to h i gh temperatures it is recommended that medicines be stored in a cool place

Activity Prepare a list of the storage requirements mentioned on the label of about 20 products in your pharmacy and check if the temperature is maintained

47

25 Special Storage o f s u p p l i e s If the product has no special instructions normal storage conditions apply This means storage in dry clean w e l l -ventilated premises at temperatures of +15 C to +25 C or depending on the climate up to +30 C (WHO1990) Storage instructions are product specific Different brands of the same generic drug may have different storage requirements as they may have different packaging or formulations It is essential to follow the product manufacturers storage instructions to the maximum extent possible Less stable medicines must be stored in specific conditions to maintain their quality or potency

The following products require special storage facilities

middot Products that must be kept frozen (usually vaccines and sera) middot Products sensitive to h eat an d r e q uir in g r e f r ig e r a tio n ( +2 C to +8 C) middot Products that have reduced shelf life at uncontrolled room temperature and need

mechanical ventilation or air conditioning middot Flammable products that require separate fireproof premises middot Products prone to theft o r m i s u s e

Products needing storage in a controlled environment -

The usable shelf life of the following products may be reduced if stored at uncontrolled humidity or at room temperature in hot climates -

middot Some injectables (eg adrenaline) Most injectable preparations are less stable than solid oral forms (tablets and capsules) Injectable preparations in solution are particularly unstable Many injections must be protected from light as well as heat

middot Intravenous fluids (particularly if packed in p lastic containers) middot Some suppositories pessaries creams and ointments These products may melt at

temperatures greater than 30 C Once this happens it is not advisable to use them because the active ingredient in the formula may get unevenly distributed

middot Products containing rubber latex cellulose or some plastics Condoms most sterile disposable medical devices and surgical products such as syringes needles and catheters require protection from excessive humidity and strong light and heat Any o f these conditions may make products brittle stained amp unusable Sterility cannot be assumed if packaging is damaged

In hot climates these products should be stored in the coolest place possible preferably with air conditioning or air circulation fans

48

Products needing freezing or refrigeration-middot Vaccines blood products and many other medicines lose potency if kept even for a

brief period at temperatures outside the recommended range For these products the cold chain must be maintained at every stage of the distribution system

middot Freezing is as damaging as high temperatures for some products including injectable contraceptives ergometrine insulin adrenaline and the DPT DT TT and Hepatitis B vaccines Such products therefore sho uld not be allowed to freeze (not be kept in the freezer compartment)

middot Short periods at room temperature (during transportation or local distribution for instance) may be acceptable for many products (such as ergometrine a n d i n s u l i n ) e v e n t h o u g h s u c h e x posure can to some extent reduce shelf life Other items such as vaccines should always be transported in cold boxes

Storage of insulin injections-

middot Insulin should always be stored in a refrigerator at the recommended temperature of 2 -8 C

middot Insulin should not be kept in the freezer compartment of the refrigerator middot Insulin should ideally be stored horizontally middot It should not be exposed to sunlight or excessive heat middot Insulin suspensions should not be used if the suspension cannot be properly

resuspended due to cake or clump formationbull

Controlled drugs -Narcotics (for example Pethidine injection morphine preparations) and other specified drugs that may be abused are governed by special legislation and regulations The following security measures are suggested in the pharmacy -middot A safe or reinforced double locked cabinet fitted with a light (preferably with a red

bulb) that comes on when the door is opened

49

middot A special register recording details of each receipt or issue with 2 signatures physi cal counting of medicines after each entry and signatures at handover takeover

middot Independent audit (by supervisors and drug inspectors)

Products prone to theft abuse or misuse -

Some medicinesproducts are particularly prone to theft abuse or misuse These include expensive medicines (eg insulin) certain antibiotics and products prone to abuse or misuse like psychotropics etc

Such medicinesproducts should be stored adequately They require stricter record keeping and more frequent stock taki ng than others Periodic audits should be carried out to check for consumption against actual recorded use (registers prescription records stock records etc) to expose any theft or misuse bull26 Storage and stability of medicines Medicines are not stab le indefinitely They are stable for a specific period of time sometimes for a brief period Poor storage conditions accelerate the drug degradation (decomposition) Temperature light and moisture are the most important contributing factors for drug instability It is important to identify and be aware of the potential for instability There is a need to comply with storage requirements to ensure quality medicines for patients It is also important to offer advice to patients too about appropriate storage o f medicines at home The dispensing label should state the storage condition required and be backed up by a verbal reminder especially where special storage is required bull

50

In case stability and storage problems are seen with formulations they should be reported immediately to the representative of the manufacturer and taken out of circulation till the stability problems have been resolved

The pharmacist can easily detect stability problems when products show change in appearance color odor settling of the product contents breaking of emulsions melting of creams oozing of contents from the containers and any such physical changes

3 STOCK CONTROL AND EXPIRY MONITORING 3 1 S t o c k C o n t r o l For economic reasons pharmacists do not like to have stock on their shelves for long periods of time The aim should always be to keep stock at a level that will just meet demand Normally most manufactured medicines have a long shelf life Even then it is essential that there is efficient stock rot ation so that the older stock is used first It is also a good practice to check the expiry date as an integral part of the dispensing process When short shelf life products are involved stock levels may have to be modified to prevent medicines regularl y expiring on the shelves

32 Stock rotation and expiry monitoring In order to avoid accumulation of expired and obsolete stock medicines should be stored and issued according to the following guidelines -middot The stock control system must record the ex p i r y d a t e a n d t h e d a t e o f r e c e i p t middot Stock must be stored so that earliest expiring batches are picked and issued first middot The First In First Out (FIFO) system - In this system the stock which is received

first is sold first This system however may not be useful for pharmacies because most of the stocks carry an expiry date For pharmacies the FEFO system is more practical

51

middot The First Expiry First Out (FEFO) system - In this system the stock having an earlier expiry is sold first The stock with longer shelf life should be placed farthest to the back (or at the bottom in case o f sta c k e d b oxe s) T h is is pa r tic u la r ly impor ta n t with products that have short shelf lives such as vaccines some vitamins antibiotics etc and reduces losses due to expiry

middot E x p i r y dates should be noted on the stock record upon receipt Stock nearing expiry should not be accepted unless it can be used before expiry

Computerization and expiry monitoring In the pharmacy computerization facilitates both checking stocks and expiry mo nitoring and helps-bullbullKeeping a check on products nearing expiry bullbullKeeping a check on non- moving and slow moving products bullbullTo facilitate the removal of medicines nearing expiry from shelves in time to send them back to the wholesaler or supplier

Periodic checking for expiry The expiry date for medicinal products is a critical aspect in pharmaceutical dispensing and due importance should be given to it Periodic checking for expiry of medicines will ensure that the patient will never receive products that have crossed their expiry date During periodical checking of expiry the personnel involved should remove medicines that are nearing expiry bullbullIn -house threshold periods should be set and followed for retrieval of such medicines from the shelves bullbullSuch medicines should be stored separately These should either be dispensed immediately (thus ensuring that they are used before the expiry date) o r t h e y s h o u l d b e returned to the suppliers bullbullA separate area should be designated (cupboard or shelf)marked[FROZEN ZONE] which is adequately marked EXPIRED GOODS- NOT FOR SALE to store all expired stocks FROZEN ZONE

52

Remember Expired medicines are a NATIONAL WASTE So stock only what you can sell Avoid expiries save precious medicines for the nation

Treatment and disposing of expired medicines bullbullProcedures need to be in place for the treatment of expired medicines bullbullThe expired medicines need to be collected and be sent back to the supplier or company for appropriate disposal bullbullRecords must be maintained for expired medicines and how they are disposed off bullbullIn case of medicines that are not returnable to suppliers procedures for disposal need to be followed by the pharmacy in conjunction with the FDA The following procedure can be followed if medicines cannot be returned to suppliers ( T h e b a s i c p h i l o s o p h y of appropriate disposal is to prevent their re- circulation and use) bullbullC u t t h e c o n t ainer in such a manner that the label is also cut In case of tablets and c a p s u l e s d e s t r o y them by disposing them in a bucket of water bullbullUse landfill procedures (deep burial into the ground as per stipulations of Medical Waste Disposal Act prevalent in the respective state) bullbullPour the liquids into the sink and wash away with sufficient quantity of water bullbullKeep a record of such disposal with full details of medicines destroyed Although these measures are usually adopted care has to be taken with such tr e a t m e n t a s studies have shown that flushing of medicines has resulted in tracessmall quantities of medicines being found in waterways and groundwater having potential health and environmental effects

4 O T H E R A S P E C T S 41 Design of storage areas The following important factors need to be considered in design of storage areas -middot The retail outlets in hot areas in summers should be air-conditioned Similarly in

a r e a s o f e x t r e m e c o l d t h e p r e m i s e s w o u l d r e q u i r e w a r m i n g e s p e c i a l l y i n w i n t e r s t o maintain cool temperatures The placement of air -conditioners and heating devices should be such that medicines are not directly exposed to the cold or heat

middot Due consideration should be given to storage requirements of formulations while designing shelves and cupboards in retail outlets Sufficient shelf height should be provided so that all liquid products can be stored vertically As far as possible the shelves should be covered with glass panels to protect medicines from dust and p r e v e n t r a p i d f l u c t u a t i o n s i n temperature

middot Medicines should be stored according to the storage instructions on the labels bullIt is ideal to have a door at the pharmacy entrance to prevent dust from coming in as well as reduceprevent cooled air from going out This may not however be considered feasiblepracticable by many pharmacy owners for fear that clients may not enter the pharmacy because the door may act as a barrier An air curtain is a good alternative to a door

middot There should be minimal direct sunlight falling on the products Particular consideration should be given to premises directly facing the sun

middot bullThe arrangement of lighting in the interior of the premises should also be in a manner that the lights are not focused on the products It has been shown that light causes not only chemical damage but also can catalyze physical changes like moisture uptak e by the products Care should be taken to ensure that only diffused light falls on them

53

middot As far as possible provision should be made for a temperature and humidity indicator device in a pharmacy These devices are now easily available

middot Stability studies o f m e d i c i n e s p a c k e d i n b l i s t e r s h a v e r e v e a l e d t h a t i f t h e s e a r e exposed to light they tend to absorb moisture It is therefore necessary to store them in suitable cartons so that the blisters are not exposed to light Pharmacists should do this even if the manufacturer has not provided cartons

middot Light and temperature sensitive products should not be stored on counters where the light is intense or direct and there is no protection from temperature and humidity

42 Cleaning and maintenance i) Cleaning of storage areas

The storage areas of the pharmacy should be cleaned periodically and cleanliness should be maintained at all times The Standard Operating Procedure for cleaning should be designed and followed accordingly Schedules for cleanups should be laid down and adequate cleaning equipment should be made available

Tips for maintaining cleanliness middot Provide clean pieces of cloth for wiping at various locations in the pharmacy

Replace with clean cloth at regular intervals middot Keep separate pieces of cloth for floors shelves and medicines middot Use a disinfectant andor soap solution to clean floors middot Ensure removal of dust and prevent accumulation of dirt middot Ensure removal of cobwebs middot Use a vacuum cleaner for cleaning areas not easily reachable middot T a k e c a r e t h at breakages are handled and cleared effectively middot Observe the factors leading to waste generation in the pharmacy and take appropriate

measures to tackle the problem middot Record all cleaning procedures performed and maintain all the documents required

For ex a m p l e -bullbullThe floor of the pharmacy may be swept with a broom and swabbed with soap water every morning bullbullThe floor may be swabbed with a disinfectant every week bullbullThe entire premises including shelves and cupboards may be cleaned with a cloth (to remove dust and to check for medicines approaching expiry date or expired medicines) every three months bullbullAll the steps followed should be r e c o r d e d

The floor shelves drawers have to be cleaned and a check should be kept on dust cobwebs spillages due to breakage etc It is therefore essential to have SOPs for cleaning laying down cleaning frequencies allotting responsibilities and maintaining a daily record in the logbook to document all these activities

54

While cleaning dust settled on dosage forms like bottles tubes etc should be removed Before dispensing the products should also be wiped to remove any dust settled during storage

For refrigerators bullbullDefrosting and cleaning should be done at regular intervals bullbullSwitch off the refrigerator while cleaning bullbullCleaning should be done quickly and stocks put back immediately

i i ) Pest control Pests are a serious problem in India where insects reptiles and rodents (eg cockroaches l i z a r d s r a t s s i l v e r f i s h (Deemak - in Hindi ) etc) may find access to the pharmacy storage areas Insects like ants and borer ants may often attack wood in the pharmacy causing d am ag e to shelves cupboardsPest c ontr o l in a p h a r m a c y c a n b e a d i f f i c u l t t a s k b u t t o avoid possible contamination and physical damage to stock it is necessary to keep pests out of the pharmacy premisesPest control measures should be implemented with proper p r e c a u t i o n s t a k i n g u t m o s t c a r e t o a v o i d contamination of medicines

55

Th e following pest control measures c a n be ta ke n f r om tim e to tim e -bullbullRat bait and traps can be placed at various locations bullbullInsecticutors can be used on a permanent basis bullbullInsecticidal sprays and repellants can be used from time to time

i i i ) Fire precautions

Combustible trash such as cartons boxes and other packing waste must not be allowed to accumulate in the store Waste should be deposited in appropriate waste bins and be d i s p o s e d o f f o n a d a i l y b a s i s

F i re detection and fire fighting equipment must be maintained and regularly inspected The pharmacy personnel should receive adequate training in fire fighting techniques and emergency actionFire prevention measures should include a prominently displayed ldquoNoSmokingrdquo sign careful handling and disposal of combustible waste materials and checking of electrical connections at regular intervals

iv) Security middot Doors shutters of the pharmacy should be strong and be fitted with secure locks middot Counters should be designed so that unauthorized personnelclients do not have

access to areas where prescription medicines are stored Access to such areas should be restricted to the pharmacy staff

middot All the pharmacy staff handling supplies should be accountable for their ac t i o n s

56

middot bullSpecial care must be taken in case of Schedule X and manufactured drugs (under NDPS Act) Such medicines should be kept under lock and key and the key should be kept with the Chief Pharmacist or i n h i s a b s e n c e t h e s e n i o r p h a r m a c i s t

v) Breakagespillage and damaged product Products that have been damagedspoiled during storage and handling spillages and broken glassware should be disposed off according to procedures laid down by the pharmacy Broken and damaged products s h o u l d b e p l a c e d i n a segregated area to be returned to the supplier

vi) Inspection Senior staff should inspect all pharmacy areas regularly The shelves and drawers should b e c h e c k e d d a i l y f o r signs of pests and dust Ceiling and walls should be checked for dirt and cobwebs Stock should be checked on a regular basis for deterioration due to climatic conditions

43 Product recalls Products found to be defective should be quickly recalled (withdrawn from the market) The instructions are generally issued either by the manufacturer or the regulatory agency The level of recall is determined by both the degree of risk and the extent of distribution of the product and in India is mainly directed at the distribution chain

On receiving the details of the defective substandard spurious batchbatches of a medicine to be recalled from the manufacturer or the stockist or the FDA the pharmacy should immediately check if the particular b a t c h i s i n s t o c k a n d i f s o s u s p e n d i t s s a l e immediately

Similarly if the regulatory authority in the country bans a particular medicine or FDC the pharmacy should immediately check and remove all the different brands of that particular medicine under consideration

The details of medicines and their batches to be recalled should be available in the q u a r a n t i n e a r e a w h e r e stocks are received and checked This is to ensure that such medicines do not come into the pharmacy

middot The pharmacy should develop SOPs for recall of medicines middot The pharmacy staff should be immediately informed about such medicines and

the details should be displayed in writing in a prominent place in the pharmacy middot Rapid action helps avoid unnecessary exposure to such medicines once the

problem has been d e t e c t e d middot The progress of the recall procedure in the pharmacy should be monitored every

few days to ensure complete compliance middot All stocks of the recalled products should be stored separately from the saleable

stock These can be stored in the expiry cupboard segregated from the expired goods and be appropriately labeled ldquoRecal l e d G o o d s - Not for Salerdquo

The supplier should be notified and asked to replace defective products middot All the details of the procedures followed should be duly recorded in a Recall

Register maintained specially for the purpose The register should include d etails such as -middot Date of the recall middot Nam e of the product

57

bullbull

middot Details of the product (name of manufacturer batch number expiry date) middot Nu m b er of units purchased sold a n d sto c k in ha nd middot Reason for recall middot Nam e of the supplier to whom produc ts w e r e returned along with the date and quantity middot Name and signature of the designated personnel carrying out the recall procedure and recording details middot Name and signature of the chief pharmacist verifying the recall procedures and recording details 4 4 Returned medicines

Medicines may be returned to the pharmacy by clients due to the following reasons -bull

bullbull Unused medicines bullbull Course not completed bullbull Therapy changed by doctor bullbull Side effects experienced by patient bull

bullbull DamagedDefective medicines bullbull Missing or defaced label bullbull Missing tablets in a stripblister bullbull Leakage in bottles bullbull Leakage in strips bull

bullbull Expired medicines

Appropriate SOPs should be framed and followed for their acceptancerefusal and disposal middot bull For unused medicines returned by clients the p harmacy personnel should verify

that these were purchased from their pharmacy They should then be checked for integrity of the packing the dosage form and the expiry date and verified with the client whether they were stored in appropriate conditions This again is at the discretion of each pharmacy

middot The damageddefective medicines returned to the pharmacy should be taken back and stored separately Existing stock of the same product should be checked for similar defects

middot Expired medicines should be accepted from clients at the discretion of the pharmacist and be immediately shifted to the expired goods cupboard These can be stored segregated from the pharmacys own expired goods and be appropriately labelled ldquoExpired Goods returned by clients- Not For Salerdquo

It is advisable not to accept returned medicines requiring cold chain storage (refrigeration) because it cannot be ensured that the cold chain was maintained when the medicines were in the hands of the patientclient middot Appropriate adjustments in t he stocks should be made for medicines

returnedexchanged to update the inventory middot The medicines should then be returned to the respective shelves middot A lsquoReturned Goodsrsquo register needs to be maintained to record all details of returned

medicines

R egister should include such details as-

58

middot N a m e o f t h e p a t i e n t middot Nam e of the product and quantity r e tu r n e d middot Product details such as the batch number and expiry date middot Condition in which received middot Reason for returning products middot Compensatory measures taken wi t h r e s p e c t t o c l i e n t middot Action taken with respect to product middot Name and signature of the personnel accepting the returned medicines and recording details middot Name and signature of the chief pharmacist verifying the recorded details

What the pharmacist would have learnt from this module The storage of medicines is a critical factor in the distribution cycle bullbull Stocks received by the pharmacy should be quarantined in a separate area and necessary checks s h o u ld be performed to ascertain the qua lity a nd quantity of stocks received bullbull Whatever pattern and means of storage used the products should be stored so as to maintain their potency and integrity bullbull Storage conditions should be monitored and maintained on a regular basis bullbull Optimum stock levels should be maintained and regularly monitored for expiry bullbull The design of storage areas should facilitate appropriate storage of medicines bullbull Cleanliness should be maintained in the pharmacy bullbull Adequate measures should be taken in case of returned medicines and recalled products

Optimum storage of medicines is mandatory whether at the distribution stage at the pharmacy or ultimately within the homes of patients The pharmacist has an important r o l e t o p l a y i n t h e s t o r a g e o f m e d i c i n e s i n m a i n t a i n i n g d r u g p o t ency and efficacy and thus facilitating optimum therapeutic benefits Good Pharmacy Practice - IPA -CDSCO - WHO Appendix I Quality Assurance Templates of letters for use if found not of Standard Quality [Frozen and expired goods ]

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated To Name of the Supplier with address

Sub Not of Standard Quality GoMP-Supply of Drugs and medicines-(Codename) Return of Stocks to the Suppliers-reg(New drug policy 2009) Previous letterinvoice ref Sl No Drug Code Drug name

Manufacturing date Expiry date

Supplier address

B a t c h n o

The above items of PO nodated was drawn by the Drug Inspector (Place) on (______________date) as a statutory sampling and declared ldquoNot of Standard

59

Qualityrdquo on -(______________date) by the Government Analyst for the following reasons

- ldquoThe product sample do not confirm to IP specification for (Drug codename with respect to the content of drugrdquo

- ldquoThe product has already been blacklisted by TNMSC on -(______________date) for the failure of (quantity) of batches of drug codenamerdquo

As per the clause of the te nde r d oc um e nt ldquo I f the sa mple s d o not c onf o r m to statutory standardsthe tenderer will be liable for relevant action under the existing laws and the entire stock in such batch should be taken back by the tenderer within a period of 30 days o f t h e r e c e i p t o f t h e l e t t e r f r o m t h e v e n u e

The stock shall be taken back at the expenses of the tendererthe Procurement Authority have the right to destroy such Not of Standard Quality if the tenderer does not take back the goods within the stipulated time

The Procuring Authority will arrange to destroy the Not of Standard Quality drugs within 90 days after the expiry of 30 days mentioned above without further notice and shall also collect demurrage charges calculated at the rate of 2 per week on the value of the drugs rejected till such destructionrdquo

Hence we regret to inform you that you will have to take back the stocks available of the abovesaid batch at your own cost from the drug stores where you have supplied the above batch

Kindly acknowledge the receipt of this reference at once

P r o c u r e m e n t A u t h o r i t y Seal and Stamp

Copy to Ref No dated

1 ) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated13082010

To

Sub Frozen Drugs-ordered to return to the Suppliers-reg(New drug policy 2009) Previous letterinvoice ref

The following products which were earlier frozen have now been ordered to return to suppliers directly with permission from the State drug Authority In this regard the suppliers have been instructed to take back their failed batch from the drug store of the stores Hence you are now instructed to return the following failed batches to the suppliers by obtaining proper authorization letter and acknowledgements from them

60

Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

Kindly acknowledge the receipt of this reference at once

Procurement Authority Seal and Stamp

Copy to

Ref No dated 2) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated14092010

To

Sub Frozen Drugs-ordered to return to the Suppliers- for issue of gate pass after verification reg(New drug policy 2009) Previous letterinvoice ref

The following products which were earlier frozen have now been released Hence they may be issued Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

Kindly acknowledge the receipt of this reference at once

Procurement Authority Seal and Stamp

Copy to

61

Ref No dated 3) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated

To

Sub Stop instruction-reg(New drug policy 2009) Previous letterinvoice ref

Until further instructions stop issue all the batches of the following item Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

You must intimate the available stock in the stores of the said batch Number to the Procurement Authority immediately Also retrieve quantity if already issued

Procurement Authority Seal and Stamp

Copy to

Ref No dated 4) HOD Procurement Office of

62

Appendix II Material handling in drug stores

Rack approx rates and dimensions

S No

Item Description UOM Approx Rate

1 MEDIUM DUTY RACK SIZE 2900 H X 3090 W X 800 D IN MM (AS PER SPECIFICATION)

Each 2499800

2 MEDIUM DUTY RACK ADD ON UNIT FOR SIZE OF SR NO2

Each 2243100

To locate a Box no 3 Rack no 14 in row3

SAMPLE OF RACK no Bin numbering -------------- S a y R K 1 4 R o w 3 B o x 1 6

SAMPLE LAYOUT of RACKS in a Drug Stores

63

Sample of another warehouse of distribution warehouse system

64

65

Slotted Angle racks with bin cards

66

Plastic Pallets

Plastic pallets ar e l i g h t w e i g h t l o w- c ost and exceed industry standards for strength and durability

NOTE A pallet has bottom deckboards (see sketch) A skid does not have bottom

67

deckboards

Battery Operated Stacker

Electric Stacker Ehh (Manual Push Type) - Manual drive - Lifting electrically with Battery 12 V 88 Ah - For loading and un-loading of trucks - Battery and loading device built - in - Battery charge gauge and charging current gauge Simple and Easy Operation - Lifting and Lowering electrically direct on steering arm - Pulling and pushing through steering arm - Electrically operated relief valve on hydraulic aggregate Safe Operation - Emergency Off Switch - Constant lowering speed - Protection through lowering brake valve - Overload protection through overload brake valve - Load chains covered preventing pinching threat - Electrically interlocking during loading process - Secured battery compartment opens upwardly - Stable buffering of the steering arm in upright position - In accordance with EWG Guidelines 89 240 - In accordance with VBG 12b Prevention of Accidents

Pallet Truck [ Top ]

68

----------------------------------------------------------------------------------------------------------------------------

For Transport Of All Goods On Pallets Safe and Easy Operation - through single hand operation Lifting moving

lowering with steering handle - neutral position of the hydraulic possible - overload pressure relief valve Long Service Life - robust co n s t r u c t i o n

- special hardened axles - hardened chromium plated ram - maintenance free Easy Maneuverability - through rubber steering rollers - nylon fork rollers

A h a n d t r o l l e y

69

Trolley with plastic bins for several items del ivery

70

Digital Weighing balances

Balances amp Scales EF Seriers Precision Electronic Balance

71

1

Ice lined Refrigerators

600 litres refrigrator

72

Walk in cooler

vacuum cleaner

73

2 4 T e m p e r a t u r e c l i m a t i c c o n d i t i o n s

i) Temperature control middot The medicines in a pharmacy need to be stored at appropriate temperatures to

maintain their stability middot An air-conditioned environment where temperature can be controlled is

recommended for pharmacies Air conditioning offers the option of setting the t e m p e rature as per requirements

middot bullIt is ideal to have an air conditioner to maintain the temperature below 25 C as most medicines require storage below this temperature Secondly this temperature is pleasing to both the staff and the visiting customers too

middot In the absence of an air conditioner circulating fans may be used middot This need is felt even more in certain parts of India where temperatures soar above 45

C and some areas where it falls to sub zero temperatures In such cases temperature maintenance is essential to prevent deterioration of medicines due to unnecessary exposure to drastic temperature fluctuations

middot This need is felt even more in certain parts of India where temperatures soar above 45 C and some areas where it falls to sub zero temperat u r e s I n s u c h c a s e s temperature maintenance is essential to prevent deterioration of medicines due to unnecessary exposure to drastic temperature fluctuations

i i ) Humidity or moisture control Moisture or humidity can adversely affect the stability of me dicines such as tablets capsules powders

45

Gelatin capsules become soft and swell on absorption of moisture The drug content of tablets may undergo surface hydrolysis The presence of moisture may encourage the growth of microbes It is therefore essential to control humidity

To reduce the effect of humidity the following suggestions may be followed -middot Open the windows to allow air circulation Use a fan to circulate fresh (outside) air middot In humid climate a dehumidifier is useful for preventing mo i s t u r e d a m a g e ( i n t h e absence of an air conditioner) middot For bulk containers of tabletscapsules do not keep the container open for a long time and replace the lid or closure immediately after taking out the required number of medicines for dispensing middot Do not allow the medicines to touch the floor or the walls The walls may be damp and may cause moisture absorption damaging the product

middot Calibrated thermometers and manometers can be used to detect temperature and humidity in the pharmacy

middot Periodici t y of checking the temperature should be fixed middot The climatic conditions should be recorded and documented middot Temperature charts should be available for ready reference

Documentation is one of the core activities for achieving and maintaining quality It is one of the most essential components of validation Temperatures in various areas

46

including refrigerators should be recorded at a predetermined periodicity usually daily at the hottest time of the day and such documents should be preserved i i i ) Storage conditions A number of storage conditions are mentioned on the labels of medicinal products These conditions have to be properly interpreted and appropriately complied with

According to the Drugs and Cosmetics Rules 1945

1 The term cool place means a place having a temperature between 10 C and 25 C

2 The term cold place means a place having a temperature not exceeding 8 C In case of storage conditions for specific products please refer to Schedule P The Drugs and Cosmetic Rules 1 9 4 5

The Indian Pharmacopoeia specifies the following storage conditions -

Wherever the condition for storage is not specified medicines may be stored under normal temperature In a country like India however where normal temperatures soar to h i gh temperatures it is recommended that medicines be stored in a cool place

Activity Prepare a list of the storage requirements mentioned on the label of about 20 products in your pharmacy and check if the temperature is maintained

47

25 Special Storage o f s u p p l i e s If the product has no special instructions normal storage conditions apply This means storage in dry clean w e l l -ventilated premises at temperatures of +15 C to +25 C or depending on the climate up to +30 C (WHO1990) Storage instructions are product specific Different brands of the same generic drug may have different storage requirements as they may have different packaging or formulations It is essential to follow the product manufacturers storage instructions to the maximum extent possible Less stable medicines must be stored in specific conditions to maintain their quality or potency

The following products require special storage facilities

middot Products that must be kept frozen (usually vaccines and sera) middot Products sensitive to h eat an d r e q uir in g r e f r ig e r a tio n ( +2 C to +8 C) middot Products that have reduced shelf life at uncontrolled room temperature and need

mechanical ventilation or air conditioning middot Flammable products that require separate fireproof premises middot Products prone to theft o r m i s u s e

Products needing storage in a controlled environment -

The usable shelf life of the following products may be reduced if stored at uncontrolled humidity or at room temperature in hot climates -

middot Some injectables (eg adrenaline) Most injectable preparations are less stable than solid oral forms (tablets and capsules) Injectable preparations in solution are particularly unstable Many injections must be protected from light as well as heat

middot Intravenous fluids (particularly if packed in p lastic containers) middot Some suppositories pessaries creams and ointments These products may melt at

temperatures greater than 30 C Once this happens it is not advisable to use them because the active ingredient in the formula may get unevenly distributed

middot Products containing rubber latex cellulose or some plastics Condoms most sterile disposable medical devices and surgical products such as syringes needles and catheters require protection from excessive humidity and strong light and heat Any o f these conditions may make products brittle stained amp unusable Sterility cannot be assumed if packaging is damaged

In hot climates these products should be stored in the coolest place possible preferably with air conditioning or air circulation fans

48

Products needing freezing or refrigeration-middot Vaccines blood products and many other medicines lose potency if kept even for a

brief period at temperatures outside the recommended range For these products the cold chain must be maintained at every stage of the distribution system

middot Freezing is as damaging as high temperatures for some products including injectable contraceptives ergometrine insulin adrenaline and the DPT DT TT and Hepatitis B vaccines Such products therefore sho uld not be allowed to freeze (not be kept in the freezer compartment)

middot Short periods at room temperature (during transportation or local distribution for instance) may be acceptable for many products (such as ergometrine a n d i n s u l i n ) e v e n t h o u g h s u c h e x posure can to some extent reduce shelf life Other items such as vaccines should always be transported in cold boxes

Storage of insulin injections-

middot Insulin should always be stored in a refrigerator at the recommended temperature of 2 -8 C

middot Insulin should not be kept in the freezer compartment of the refrigerator middot Insulin should ideally be stored horizontally middot It should not be exposed to sunlight or excessive heat middot Insulin suspensions should not be used if the suspension cannot be properly

resuspended due to cake or clump formationbull

Controlled drugs -Narcotics (for example Pethidine injection morphine preparations) and other specified drugs that may be abused are governed by special legislation and regulations The following security measures are suggested in the pharmacy -middot A safe or reinforced double locked cabinet fitted with a light (preferably with a red

bulb) that comes on when the door is opened

49

middot A special register recording details of each receipt or issue with 2 signatures physi cal counting of medicines after each entry and signatures at handover takeover

middot Independent audit (by supervisors and drug inspectors)

Products prone to theft abuse or misuse -

Some medicinesproducts are particularly prone to theft abuse or misuse These include expensive medicines (eg insulin) certain antibiotics and products prone to abuse or misuse like psychotropics etc

Such medicinesproducts should be stored adequately They require stricter record keeping and more frequent stock taki ng than others Periodic audits should be carried out to check for consumption against actual recorded use (registers prescription records stock records etc) to expose any theft or misuse bull26 Storage and stability of medicines Medicines are not stab le indefinitely They are stable for a specific period of time sometimes for a brief period Poor storage conditions accelerate the drug degradation (decomposition) Temperature light and moisture are the most important contributing factors for drug instability It is important to identify and be aware of the potential for instability There is a need to comply with storage requirements to ensure quality medicines for patients It is also important to offer advice to patients too about appropriate storage o f medicines at home The dispensing label should state the storage condition required and be backed up by a verbal reminder especially where special storage is required bull

50

In case stability and storage problems are seen with formulations they should be reported immediately to the representative of the manufacturer and taken out of circulation till the stability problems have been resolved

The pharmacist can easily detect stability problems when products show change in appearance color odor settling of the product contents breaking of emulsions melting of creams oozing of contents from the containers and any such physical changes

3 STOCK CONTROL AND EXPIRY MONITORING 3 1 S t o c k C o n t r o l For economic reasons pharmacists do not like to have stock on their shelves for long periods of time The aim should always be to keep stock at a level that will just meet demand Normally most manufactured medicines have a long shelf life Even then it is essential that there is efficient stock rot ation so that the older stock is used first It is also a good practice to check the expiry date as an integral part of the dispensing process When short shelf life products are involved stock levels may have to be modified to prevent medicines regularl y expiring on the shelves

32 Stock rotation and expiry monitoring In order to avoid accumulation of expired and obsolete stock medicines should be stored and issued according to the following guidelines -middot The stock control system must record the ex p i r y d a t e a n d t h e d a t e o f r e c e i p t middot Stock must be stored so that earliest expiring batches are picked and issued first middot The First In First Out (FIFO) system - In this system the stock which is received

first is sold first This system however may not be useful for pharmacies because most of the stocks carry an expiry date For pharmacies the FEFO system is more practical

51

middot The First Expiry First Out (FEFO) system - In this system the stock having an earlier expiry is sold first The stock with longer shelf life should be placed farthest to the back (or at the bottom in case o f sta c k e d b oxe s) T h is is pa r tic u la r ly impor ta n t with products that have short shelf lives such as vaccines some vitamins antibiotics etc and reduces losses due to expiry

middot E x p i r y dates should be noted on the stock record upon receipt Stock nearing expiry should not be accepted unless it can be used before expiry

Computerization and expiry monitoring In the pharmacy computerization facilitates both checking stocks and expiry mo nitoring and helps-bullbullKeeping a check on products nearing expiry bullbullKeeping a check on non- moving and slow moving products bullbullTo facilitate the removal of medicines nearing expiry from shelves in time to send them back to the wholesaler or supplier

Periodic checking for expiry The expiry date for medicinal products is a critical aspect in pharmaceutical dispensing and due importance should be given to it Periodic checking for expiry of medicines will ensure that the patient will never receive products that have crossed their expiry date During periodical checking of expiry the personnel involved should remove medicines that are nearing expiry bullbullIn -house threshold periods should be set and followed for retrieval of such medicines from the shelves bullbullSuch medicines should be stored separately These should either be dispensed immediately (thus ensuring that they are used before the expiry date) o r t h e y s h o u l d b e returned to the suppliers bullbullA separate area should be designated (cupboard or shelf)marked[FROZEN ZONE] which is adequately marked EXPIRED GOODS- NOT FOR SALE to store all expired stocks FROZEN ZONE

52

Remember Expired medicines are a NATIONAL WASTE So stock only what you can sell Avoid expiries save precious medicines for the nation

Treatment and disposing of expired medicines bullbullProcedures need to be in place for the treatment of expired medicines bullbullThe expired medicines need to be collected and be sent back to the supplier or company for appropriate disposal bullbullRecords must be maintained for expired medicines and how they are disposed off bullbullIn case of medicines that are not returnable to suppliers procedures for disposal need to be followed by the pharmacy in conjunction with the FDA The following procedure can be followed if medicines cannot be returned to suppliers ( T h e b a s i c p h i l o s o p h y of appropriate disposal is to prevent their re- circulation and use) bullbullC u t t h e c o n t ainer in such a manner that the label is also cut In case of tablets and c a p s u l e s d e s t r o y them by disposing them in a bucket of water bullbullUse landfill procedures (deep burial into the ground as per stipulations of Medical Waste Disposal Act prevalent in the respective state) bullbullPour the liquids into the sink and wash away with sufficient quantity of water bullbullKeep a record of such disposal with full details of medicines destroyed Although these measures are usually adopted care has to be taken with such tr e a t m e n t a s studies have shown that flushing of medicines has resulted in tracessmall quantities of medicines being found in waterways and groundwater having potential health and environmental effects

4 O T H E R A S P E C T S 41 Design of storage areas The following important factors need to be considered in design of storage areas -middot The retail outlets in hot areas in summers should be air-conditioned Similarly in

a r e a s o f e x t r e m e c o l d t h e p r e m i s e s w o u l d r e q u i r e w a r m i n g e s p e c i a l l y i n w i n t e r s t o maintain cool temperatures The placement of air -conditioners and heating devices should be such that medicines are not directly exposed to the cold or heat

middot Due consideration should be given to storage requirements of formulations while designing shelves and cupboards in retail outlets Sufficient shelf height should be provided so that all liquid products can be stored vertically As far as possible the shelves should be covered with glass panels to protect medicines from dust and p r e v e n t r a p i d f l u c t u a t i o n s i n temperature

middot Medicines should be stored according to the storage instructions on the labels bullIt is ideal to have a door at the pharmacy entrance to prevent dust from coming in as well as reduceprevent cooled air from going out This may not however be considered feasiblepracticable by many pharmacy owners for fear that clients may not enter the pharmacy because the door may act as a barrier An air curtain is a good alternative to a door

middot There should be minimal direct sunlight falling on the products Particular consideration should be given to premises directly facing the sun

middot bullThe arrangement of lighting in the interior of the premises should also be in a manner that the lights are not focused on the products It has been shown that light causes not only chemical damage but also can catalyze physical changes like moisture uptak e by the products Care should be taken to ensure that only diffused light falls on them

53

middot As far as possible provision should be made for a temperature and humidity indicator device in a pharmacy These devices are now easily available

middot Stability studies o f m e d i c i n e s p a c k e d i n b l i s t e r s h a v e r e v e a l e d t h a t i f t h e s e a r e exposed to light they tend to absorb moisture It is therefore necessary to store them in suitable cartons so that the blisters are not exposed to light Pharmacists should do this even if the manufacturer has not provided cartons

middot Light and temperature sensitive products should not be stored on counters where the light is intense or direct and there is no protection from temperature and humidity

42 Cleaning and maintenance i) Cleaning of storage areas

The storage areas of the pharmacy should be cleaned periodically and cleanliness should be maintained at all times The Standard Operating Procedure for cleaning should be designed and followed accordingly Schedules for cleanups should be laid down and adequate cleaning equipment should be made available

Tips for maintaining cleanliness middot Provide clean pieces of cloth for wiping at various locations in the pharmacy

Replace with clean cloth at regular intervals middot Keep separate pieces of cloth for floors shelves and medicines middot Use a disinfectant andor soap solution to clean floors middot Ensure removal of dust and prevent accumulation of dirt middot Ensure removal of cobwebs middot Use a vacuum cleaner for cleaning areas not easily reachable middot T a k e c a r e t h at breakages are handled and cleared effectively middot Observe the factors leading to waste generation in the pharmacy and take appropriate

measures to tackle the problem middot Record all cleaning procedures performed and maintain all the documents required

For ex a m p l e -bullbullThe floor of the pharmacy may be swept with a broom and swabbed with soap water every morning bullbullThe floor may be swabbed with a disinfectant every week bullbullThe entire premises including shelves and cupboards may be cleaned with a cloth (to remove dust and to check for medicines approaching expiry date or expired medicines) every three months bullbullAll the steps followed should be r e c o r d e d

The floor shelves drawers have to be cleaned and a check should be kept on dust cobwebs spillages due to breakage etc It is therefore essential to have SOPs for cleaning laying down cleaning frequencies allotting responsibilities and maintaining a daily record in the logbook to document all these activities

54

While cleaning dust settled on dosage forms like bottles tubes etc should be removed Before dispensing the products should also be wiped to remove any dust settled during storage

For refrigerators bullbullDefrosting and cleaning should be done at regular intervals bullbullSwitch off the refrigerator while cleaning bullbullCleaning should be done quickly and stocks put back immediately

i i ) Pest control Pests are a serious problem in India where insects reptiles and rodents (eg cockroaches l i z a r d s r a t s s i l v e r f i s h (Deemak - in Hindi ) etc) may find access to the pharmacy storage areas Insects like ants and borer ants may often attack wood in the pharmacy causing d am ag e to shelves cupboardsPest c ontr o l in a p h a r m a c y c a n b e a d i f f i c u l t t a s k b u t t o avoid possible contamination and physical damage to stock it is necessary to keep pests out of the pharmacy premisesPest control measures should be implemented with proper p r e c a u t i o n s t a k i n g u t m o s t c a r e t o a v o i d contamination of medicines

55

Th e following pest control measures c a n be ta ke n f r om tim e to tim e -bullbullRat bait and traps can be placed at various locations bullbullInsecticutors can be used on a permanent basis bullbullInsecticidal sprays and repellants can be used from time to time

i i i ) Fire precautions

Combustible trash such as cartons boxes and other packing waste must not be allowed to accumulate in the store Waste should be deposited in appropriate waste bins and be d i s p o s e d o f f o n a d a i l y b a s i s

F i re detection and fire fighting equipment must be maintained and regularly inspected The pharmacy personnel should receive adequate training in fire fighting techniques and emergency actionFire prevention measures should include a prominently displayed ldquoNoSmokingrdquo sign careful handling and disposal of combustible waste materials and checking of electrical connections at regular intervals

iv) Security middot Doors shutters of the pharmacy should be strong and be fitted with secure locks middot Counters should be designed so that unauthorized personnelclients do not have

access to areas where prescription medicines are stored Access to such areas should be restricted to the pharmacy staff

middot All the pharmacy staff handling supplies should be accountable for their ac t i o n s

56

middot bullSpecial care must be taken in case of Schedule X and manufactured drugs (under NDPS Act) Such medicines should be kept under lock and key and the key should be kept with the Chief Pharmacist or i n h i s a b s e n c e t h e s e n i o r p h a r m a c i s t

v) Breakagespillage and damaged product Products that have been damagedspoiled during storage and handling spillages and broken glassware should be disposed off according to procedures laid down by the pharmacy Broken and damaged products s h o u l d b e p l a c e d i n a segregated area to be returned to the supplier

vi) Inspection Senior staff should inspect all pharmacy areas regularly The shelves and drawers should b e c h e c k e d d a i l y f o r signs of pests and dust Ceiling and walls should be checked for dirt and cobwebs Stock should be checked on a regular basis for deterioration due to climatic conditions

43 Product recalls Products found to be defective should be quickly recalled (withdrawn from the market) The instructions are generally issued either by the manufacturer or the regulatory agency The level of recall is determined by both the degree of risk and the extent of distribution of the product and in India is mainly directed at the distribution chain

On receiving the details of the defective substandard spurious batchbatches of a medicine to be recalled from the manufacturer or the stockist or the FDA the pharmacy should immediately check if the particular b a t c h i s i n s t o c k a n d i f s o s u s p e n d i t s s a l e immediately

Similarly if the regulatory authority in the country bans a particular medicine or FDC the pharmacy should immediately check and remove all the different brands of that particular medicine under consideration

The details of medicines and their batches to be recalled should be available in the q u a r a n t i n e a r e a w h e r e stocks are received and checked This is to ensure that such medicines do not come into the pharmacy

middot The pharmacy should develop SOPs for recall of medicines middot The pharmacy staff should be immediately informed about such medicines and

the details should be displayed in writing in a prominent place in the pharmacy middot Rapid action helps avoid unnecessary exposure to such medicines once the

problem has been d e t e c t e d middot The progress of the recall procedure in the pharmacy should be monitored every

few days to ensure complete compliance middot All stocks of the recalled products should be stored separately from the saleable

stock These can be stored in the expiry cupboard segregated from the expired goods and be appropriately labeled ldquoRecal l e d G o o d s - Not for Salerdquo

The supplier should be notified and asked to replace defective products middot All the details of the procedures followed should be duly recorded in a Recall

Register maintained specially for the purpose The register should include d etails such as -middot Date of the recall middot Nam e of the product

57

bullbull

middot Details of the product (name of manufacturer batch number expiry date) middot Nu m b er of units purchased sold a n d sto c k in ha nd middot Reason for recall middot Nam e of the supplier to whom produc ts w e r e returned along with the date and quantity middot Name and signature of the designated personnel carrying out the recall procedure and recording details middot Name and signature of the chief pharmacist verifying the recall procedures and recording details 4 4 Returned medicines

Medicines may be returned to the pharmacy by clients due to the following reasons -bull

bullbull Unused medicines bullbull Course not completed bullbull Therapy changed by doctor bullbull Side effects experienced by patient bull

bullbull DamagedDefective medicines bullbull Missing or defaced label bullbull Missing tablets in a stripblister bullbull Leakage in bottles bullbull Leakage in strips bull

bullbull Expired medicines

Appropriate SOPs should be framed and followed for their acceptancerefusal and disposal middot bull For unused medicines returned by clients the p harmacy personnel should verify

that these were purchased from their pharmacy They should then be checked for integrity of the packing the dosage form and the expiry date and verified with the client whether they were stored in appropriate conditions This again is at the discretion of each pharmacy

middot The damageddefective medicines returned to the pharmacy should be taken back and stored separately Existing stock of the same product should be checked for similar defects

middot Expired medicines should be accepted from clients at the discretion of the pharmacist and be immediately shifted to the expired goods cupboard These can be stored segregated from the pharmacys own expired goods and be appropriately labelled ldquoExpired Goods returned by clients- Not For Salerdquo

It is advisable not to accept returned medicines requiring cold chain storage (refrigeration) because it cannot be ensured that the cold chain was maintained when the medicines were in the hands of the patientclient middot Appropriate adjustments in t he stocks should be made for medicines

returnedexchanged to update the inventory middot The medicines should then be returned to the respective shelves middot A lsquoReturned Goodsrsquo register needs to be maintained to record all details of returned

medicines

R egister should include such details as-

58

middot N a m e o f t h e p a t i e n t middot Nam e of the product and quantity r e tu r n e d middot Product details such as the batch number and expiry date middot Condition in which received middot Reason for returning products middot Compensatory measures taken wi t h r e s p e c t t o c l i e n t middot Action taken with respect to product middot Name and signature of the personnel accepting the returned medicines and recording details middot Name and signature of the chief pharmacist verifying the recorded details

What the pharmacist would have learnt from this module The storage of medicines is a critical factor in the distribution cycle bullbull Stocks received by the pharmacy should be quarantined in a separate area and necessary checks s h o u ld be performed to ascertain the qua lity a nd quantity of stocks received bullbull Whatever pattern and means of storage used the products should be stored so as to maintain their potency and integrity bullbull Storage conditions should be monitored and maintained on a regular basis bullbull Optimum stock levels should be maintained and regularly monitored for expiry bullbull The design of storage areas should facilitate appropriate storage of medicines bullbull Cleanliness should be maintained in the pharmacy bullbull Adequate measures should be taken in case of returned medicines and recalled products

Optimum storage of medicines is mandatory whether at the distribution stage at the pharmacy or ultimately within the homes of patients The pharmacist has an important r o l e t o p l a y i n t h e s t o r a g e o f m e d i c i n e s i n m a i n t a i n i n g d r u g p o t ency and efficacy and thus facilitating optimum therapeutic benefits Good Pharmacy Practice - IPA -CDSCO - WHO Appendix I Quality Assurance Templates of letters for use if found not of Standard Quality [Frozen and expired goods ]

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated To Name of the Supplier with address

Sub Not of Standard Quality GoMP-Supply of Drugs and medicines-(Codename) Return of Stocks to the Suppliers-reg(New drug policy 2009) Previous letterinvoice ref Sl No Drug Code Drug name

Manufacturing date Expiry date

Supplier address

B a t c h n o

The above items of PO nodated was drawn by the Drug Inspector (Place) on (______________date) as a statutory sampling and declared ldquoNot of Standard

59

Qualityrdquo on -(______________date) by the Government Analyst for the following reasons

- ldquoThe product sample do not confirm to IP specification for (Drug codename with respect to the content of drugrdquo

- ldquoThe product has already been blacklisted by TNMSC on -(______________date) for the failure of (quantity) of batches of drug codenamerdquo

As per the clause of the te nde r d oc um e nt ldquo I f the sa mple s d o not c onf o r m to statutory standardsthe tenderer will be liable for relevant action under the existing laws and the entire stock in such batch should be taken back by the tenderer within a period of 30 days o f t h e r e c e i p t o f t h e l e t t e r f r o m t h e v e n u e

The stock shall be taken back at the expenses of the tendererthe Procurement Authority have the right to destroy such Not of Standard Quality if the tenderer does not take back the goods within the stipulated time

The Procuring Authority will arrange to destroy the Not of Standard Quality drugs within 90 days after the expiry of 30 days mentioned above without further notice and shall also collect demurrage charges calculated at the rate of 2 per week on the value of the drugs rejected till such destructionrdquo

Hence we regret to inform you that you will have to take back the stocks available of the abovesaid batch at your own cost from the drug stores where you have supplied the above batch

Kindly acknowledge the receipt of this reference at once

P r o c u r e m e n t A u t h o r i t y Seal and Stamp

Copy to Ref No dated

1 ) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated13082010

To

Sub Frozen Drugs-ordered to return to the Suppliers-reg(New drug policy 2009) Previous letterinvoice ref

The following products which were earlier frozen have now been ordered to return to suppliers directly with permission from the State drug Authority In this regard the suppliers have been instructed to take back their failed batch from the drug store of the stores Hence you are now instructed to return the following failed batches to the suppliers by obtaining proper authorization letter and acknowledgements from them

60

Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

Kindly acknowledge the receipt of this reference at once

Procurement Authority Seal and Stamp

Copy to

Ref No dated 2) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated14092010

To

Sub Frozen Drugs-ordered to return to the Suppliers- for issue of gate pass after verification reg(New drug policy 2009) Previous letterinvoice ref

The following products which were earlier frozen have now been released Hence they may be issued Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

Kindly acknowledge the receipt of this reference at once

Procurement Authority Seal and Stamp

Copy to

61

Ref No dated 3) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated

To

Sub Stop instruction-reg(New drug policy 2009) Previous letterinvoice ref

Until further instructions stop issue all the batches of the following item Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

You must intimate the available stock in the stores of the said batch Number to the Procurement Authority immediately Also retrieve quantity if already issued

Procurement Authority Seal and Stamp

Copy to

Ref No dated 4) HOD Procurement Office of

62

Appendix II Material handling in drug stores

Rack approx rates and dimensions

S No

Item Description UOM Approx Rate

1 MEDIUM DUTY RACK SIZE 2900 H X 3090 W X 800 D IN MM (AS PER SPECIFICATION)

Each 2499800

2 MEDIUM DUTY RACK ADD ON UNIT FOR SIZE OF SR NO2

Each 2243100

To locate a Box no 3 Rack no 14 in row3

SAMPLE OF RACK no Bin numbering -------------- S a y R K 1 4 R o w 3 B o x 1 6

SAMPLE LAYOUT of RACKS in a Drug Stores

63

Sample of another warehouse of distribution warehouse system

64

65

Slotted Angle racks with bin cards

66

Plastic Pallets

Plastic pallets ar e l i g h t w e i g h t l o w- c ost and exceed industry standards for strength and durability

NOTE A pallet has bottom deckboards (see sketch) A skid does not have bottom

67

deckboards

Battery Operated Stacker

Electric Stacker Ehh (Manual Push Type) - Manual drive - Lifting electrically with Battery 12 V 88 Ah - For loading and un-loading of trucks - Battery and loading device built - in - Battery charge gauge and charging current gauge Simple and Easy Operation - Lifting and Lowering electrically direct on steering arm - Pulling and pushing through steering arm - Electrically operated relief valve on hydraulic aggregate Safe Operation - Emergency Off Switch - Constant lowering speed - Protection through lowering brake valve - Overload protection through overload brake valve - Load chains covered preventing pinching threat - Electrically interlocking during loading process - Secured battery compartment opens upwardly - Stable buffering of the steering arm in upright position - In accordance with EWG Guidelines 89 240 - In accordance with VBG 12b Prevention of Accidents

Pallet Truck [ Top ]

68

----------------------------------------------------------------------------------------------------------------------------

For Transport Of All Goods On Pallets Safe and Easy Operation - through single hand operation Lifting moving

lowering with steering handle - neutral position of the hydraulic possible - overload pressure relief valve Long Service Life - robust co n s t r u c t i o n

- special hardened axles - hardened chromium plated ram - maintenance free Easy Maneuverability - through rubber steering rollers - nylon fork rollers

A h a n d t r o l l e y

69

Trolley with plastic bins for several items del ivery

70

Digital Weighing balances

Balances amp Scales EF Seriers Precision Electronic Balance

71

1

Ice lined Refrigerators

600 litres refrigrator

72

Walk in cooler

vacuum cleaner

73

Gelatin capsules become soft and swell on absorption of moisture The drug content of tablets may undergo surface hydrolysis The presence of moisture may encourage the growth of microbes It is therefore essential to control humidity

To reduce the effect of humidity the following suggestions may be followed -middot Open the windows to allow air circulation Use a fan to circulate fresh (outside) air middot In humid climate a dehumidifier is useful for preventing mo i s t u r e d a m a g e ( i n t h e absence of an air conditioner) middot For bulk containers of tabletscapsules do not keep the container open for a long time and replace the lid or closure immediately after taking out the required number of medicines for dispensing middot Do not allow the medicines to touch the floor or the walls The walls may be damp and may cause moisture absorption damaging the product

middot Calibrated thermometers and manometers can be used to detect temperature and humidity in the pharmacy

middot Periodici t y of checking the temperature should be fixed middot The climatic conditions should be recorded and documented middot Temperature charts should be available for ready reference

Documentation is one of the core activities for achieving and maintaining quality It is one of the most essential components of validation Temperatures in various areas

46

including refrigerators should be recorded at a predetermined periodicity usually daily at the hottest time of the day and such documents should be preserved i i i ) Storage conditions A number of storage conditions are mentioned on the labels of medicinal products These conditions have to be properly interpreted and appropriately complied with

According to the Drugs and Cosmetics Rules 1945

1 The term cool place means a place having a temperature between 10 C and 25 C

2 The term cold place means a place having a temperature not exceeding 8 C In case of storage conditions for specific products please refer to Schedule P The Drugs and Cosmetic Rules 1 9 4 5

The Indian Pharmacopoeia specifies the following storage conditions -

Wherever the condition for storage is not specified medicines may be stored under normal temperature In a country like India however where normal temperatures soar to h i gh temperatures it is recommended that medicines be stored in a cool place

Activity Prepare a list of the storage requirements mentioned on the label of about 20 products in your pharmacy and check if the temperature is maintained

47

25 Special Storage o f s u p p l i e s If the product has no special instructions normal storage conditions apply This means storage in dry clean w e l l -ventilated premises at temperatures of +15 C to +25 C or depending on the climate up to +30 C (WHO1990) Storage instructions are product specific Different brands of the same generic drug may have different storage requirements as they may have different packaging or formulations It is essential to follow the product manufacturers storage instructions to the maximum extent possible Less stable medicines must be stored in specific conditions to maintain their quality or potency

The following products require special storage facilities

middot Products that must be kept frozen (usually vaccines and sera) middot Products sensitive to h eat an d r e q uir in g r e f r ig e r a tio n ( +2 C to +8 C) middot Products that have reduced shelf life at uncontrolled room temperature and need

mechanical ventilation or air conditioning middot Flammable products that require separate fireproof premises middot Products prone to theft o r m i s u s e

Products needing storage in a controlled environment -

The usable shelf life of the following products may be reduced if stored at uncontrolled humidity or at room temperature in hot climates -

middot Some injectables (eg adrenaline) Most injectable preparations are less stable than solid oral forms (tablets and capsules) Injectable preparations in solution are particularly unstable Many injections must be protected from light as well as heat

middot Intravenous fluids (particularly if packed in p lastic containers) middot Some suppositories pessaries creams and ointments These products may melt at

temperatures greater than 30 C Once this happens it is not advisable to use them because the active ingredient in the formula may get unevenly distributed

middot Products containing rubber latex cellulose or some plastics Condoms most sterile disposable medical devices and surgical products such as syringes needles and catheters require protection from excessive humidity and strong light and heat Any o f these conditions may make products brittle stained amp unusable Sterility cannot be assumed if packaging is damaged

In hot climates these products should be stored in the coolest place possible preferably with air conditioning or air circulation fans

48

Products needing freezing or refrigeration-middot Vaccines blood products and many other medicines lose potency if kept even for a

brief period at temperatures outside the recommended range For these products the cold chain must be maintained at every stage of the distribution system

middot Freezing is as damaging as high temperatures for some products including injectable contraceptives ergometrine insulin adrenaline and the DPT DT TT and Hepatitis B vaccines Such products therefore sho uld not be allowed to freeze (not be kept in the freezer compartment)

middot Short periods at room temperature (during transportation or local distribution for instance) may be acceptable for many products (such as ergometrine a n d i n s u l i n ) e v e n t h o u g h s u c h e x posure can to some extent reduce shelf life Other items such as vaccines should always be transported in cold boxes

Storage of insulin injections-

middot Insulin should always be stored in a refrigerator at the recommended temperature of 2 -8 C

middot Insulin should not be kept in the freezer compartment of the refrigerator middot Insulin should ideally be stored horizontally middot It should not be exposed to sunlight or excessive heat middot Insulin suspensions should not be used if the suspension cannot be properly

resuspended due to cake or clump formationbull

Controlled drugs -Narcotics (for example Pethidine injection morphine preparations) and other specified drugs that may be abused are governed by special legislation and regulations The following security measures are suggested in the pharmacy -middot A safe or reinforced double locked cabinet fitted with a light (preferably with a red

bulb) that comes on when the door is opened

49

middot A special register recording details of each receipt or issue with 2 signatures physi cal counting of medicines after each entry and signatures at handover takeover

middot Independent audit (by supervisors and drug inspectors)

Products prone to theft abuse or misuse -

Some medicinesproducts are particularly prone to theft abuse or misuse These include expensive medicines (eg insulin) certain antibiotics and products prone to abuse or misuse like psychotropics etc

Such medicinesproducts should be stored adequately They require stricter record keeping and more frequent stock taki ng than others Periodic audits should be carried out to check for consumption against actual recorded use (registers prescription records stock records etc) to expose any theft or misuse bull26 Storage and stability of medicines Medicines are not stab le indefinitely They are stable for a specific period of time sometimes for a brief period Poor storage conditions accelerate the drug degradation (decomposition) Temperature light and moisture are the most important contributing factors for drug instability It is important to identify and be aware of the potential for instability There is a need to comply with storage requirements to ensure quality medicines for patients It is also important to offer advice to patients too about appropriate storage o f medicines at home The dispensing label should state the storage condition required and be backed up by a verbal reminder especially where special storage is required bull

50

In case stability and storage problems are seen with formulations they should be reported immediately to the representative of the manufacturer and taken out of circulation till the stability problems have been resolved

The pharmacist can easily detect stability problems when products show change in appearance color odor settling of the product contents breaking of emulsions melting of creams oozing of contents from the containers and any such physical changes

3 STOCK CONTROL AND EXPIRY MONITORING 3 1 S t o c k C o n t r o l For economic reasons pharmacists do not like to have stock on their shelves for long periods of time The aim should always be to keep stock at a level that will just meet demand Normally most manufactured medicines have a long shelf life Even then it is essential that there is efficient stock rot ation so that the older stock is used first It is also a good practice to check the expiry date as an integral part of the dispensing process When short shelf life products are involved stock levels may have to be modified to prevent medicines regularl y expiring on the shelves

32 Stock rotation and expiry monitoring In order to avoid accumulation of expired and obsolete stock medicines should be stored and issued according to the following guidelines -middot The stock control system must record the ex p i r y d a t e a n d t h e d a t e o f r e c e i p t middot Stock must be stored so that earliest expiring batches are picked and issued first middot The First In First Out (FIFO) system - In this system the stock which is received

first is sold first This system however may not be useful for pharmacies because most of the stocks carry an expiry date For pharmacies the FEFO system is more practical

51

middot The First Expiry First Out (FEFO) system - In this system the stock having an earlier expiry is sold first The stock with longer shelf life should be placed farthest to the back (or at the bottom in case o f sta c k e d b oxe s) T h is is pa r tic u la r ly impor ta n t with products that have short shelf lives such as vaccines some vitamins antibiotics etc and reduces losses due to expiry

middot E x p i r y dates should be noted on the stock record upon receipt Stock nearing expiry should not be accepted unless it can be used before expiry

Computerization and expiry monitoring In the pharmacy computerization facilitates both checking stocks and expiry mo nitoring and helps-bullbullKeeping a check on products nearing expiry bullbullKeeping a check on non- moving and slow moving products bullbullTo facilitate the removal of medicines nearing expiry from shelves in time to send them back to the wholesaler or supplier

Periodic checking for expiry The expiry date for medicinal products is a critical aspect in pharmaceutical dispensing and due importance should be given to it Periodic checking for expiry of medicines will ensure that the patient will never receive products that have crossed their expiry date During periodical checking of expiry the personnel involved should remove medicines that are nearing expiry bullbullIn -house threshold periods should be set and followed for retrieval of such medicines from the shelves bullbullSuch medicines should be stored separately These should either be dispensed immediately (thus ensuring that they are used before the expiry date) o r t h e y s h o u l d b e returned to the suppliers bullbullA separate area should be designated (cupboard or shelf)marked[FROZEN ZONE] which is adequately marked EXPIRED GOODS- NOT FOR SALE to store all expired stocks FROZEN ZONE

52

Remember Expired medicines are a NATIONAL WASTE So stock only what you can sell Avoid expiries save precious medicines for the nation

Treatment and disposing of expired medicines bullbullProcedures need to be in place for the treatment of expired medicines bullbullThe expired medicines need to be collected and be sent back to the supplier or company for appropriate disposal bullbullRecords must be maintained for expired medicines and how they are disposed off bullbullIn case of medicines that are not returnable to suppliers procedures for disposal need to be followed by the pharmacy in conjunction with the FDA The following procedure can be followed if medicines cannot be returned to suppliers ( T h e b a s i c p h i l o s o p h y of appropriate disposal is to prevent their re- circulation and use) bullbullC u t t h e c o n t ainer in such a manner that the label is also cut In case of tablets and c a p s u l e s d e s t r o y them by disposing them in a bucket of water bullbullUse landfill procedures (deep burial into the ground as per stipulations of Medical Waste Disposal Act prevalent in the respective state) bullbullPour the liquids into the sink and wash away with sufficient quantity of water bullbullKeep a record of such disposal with full details of medicines destroyed Although these measures are usually adopted care has to be taken with such tr e a t m e n t a s studies have shown that flushing of medicines has resulted in tracessmall quantities of medicines being found in waterways and groundwater having potential health and environmental effects

4 O T H E R A S P E C T S 41 Design of storage areas The following important factors need to be considered in design of storage areas -middot The retail outlets in hot areas in summers should be air-conditioned Similarly in

a r e a s o f e x t r e m e c o l d t h e p r e m i s e s w o u l d r e q u i r e w a r m i n g e s p e c i a l l y i n w i n t e r s t o maintain cool temperatures The placement of air -conditioners and heating devices should be such that medicines are not directly exposed to the cold or heat

middot Due consideration should be given to storage requirements of formulations while designing shelves and cupboards in retail outlets Sufficient shelf height should be provided so that all liquid products can be stored vertically As far as possible the shelves should be covered with glass panels to protect medicines from dust and p r e v e n t r a p i d f l u c t u a t i o n s i n temperature

middot Medicines should be stored according to the storage instructions on the labels bullIt is ideal to have a door at the pharmacy entrance to prevent dust from coming in as well as reduceprevent cooled air from going out This may not however be considered feasiblepracticable by many pharmacy owners for fear that clients may not enter the pharmacy because the door may act as a barrier An air curtain is a good alternative to a door

middot There should be minimal direct sunlight falling on the products Particular consideration should be given to premises directly facing the sun

middot bullThe arrangement of lighting in the interior of the premises should also be in a manner that the lights are not focused on the products It has been shown that light causes not only chemical damage but also can catalyze physical changes like moisture uptak e by the products Care should be taken to ensure that only diffused light falls on them

53

middot As far as possible provision should be made for a temperature and humidity indicator device in a pharmacy These devices are now easily available

middot Stability studies o f m e d i c i n e s p a c k e d i n b l i s t e r s h a v e r e v e a l e d t h a t i f t h e s e a r e exposed to light they tend to absorb moisture It is therefore necessary to store them in suitable cartons so that the blisters are not exposed to light Pharmacists should do this even if the manufacturer has not provided cartons

middot Light and temperature sensitive products should not be stored on counters where the light is intense or direct and there is no protection from temperature and humidity

42 Cleaning and maintenance i) Cleaning of storage areas

The storage areas of the pharmacy should be cleaned periodically and cleanliness should be maintained at all times The Standard Operating Procedure for cleaning should be designed and followed accordingly Schedules for cleanups should be laid down and adequate cleaning equipment should be made available

Tips for maintaining cleanliness middot Provide clean pieces of cloth for wiping at various locations in the pharmacy

Replace with clean cloth at regular intervals middot Keep separate pieces of cloth for floors shelves and medicines middot Use a disinfectant andor soap solution to clean floors middot Ensure removal of dust and prevent accumulation of dirt middot Ensure removal of cobwebs middot Use a vacuum cleaner for cleaning areas not easily reachable middot T a k e c a r e t h at breakages are handled and cleared effectively middot Observe the factors leading to waste generation in the pharmacy and take appropriate

measures to tackle the problem middot Record all cleaning procedures performed and maintain all the documents required

For ex a m p l e -bullbullThe floor of the pharmacy may be swept with a broom and swabbed with soap water every morning bullbullThe floor may be swabbed with a disinfectant every week bullbullThe entire premises including shelves and cupboards may be cleaned with a cloth (to remove dust and to check for medicines approaching expiry date or expired medicines) every three months bullbullAll the steps followed should be r e c o r d e d

The floor shelves drawers have to be cleaned and a check should be kept on dust cobwebs spillages due to breakage etc It is therefore essential to have SOPs for cleaning laying down cleaning frequencies allotting responsibilities and maintaining a daily record in the logbook to document all these activities

54

While cleaning dust settled on dosage forms like bottles tubes etc should be removed Before dispensing the products should also be wiped to remove any dust settled during storage

For refrigerators bullbullDefrosting and cleaning should be done at regular intervals bullbullSwitch off the refrigerator while cleaning bullbullCleaning should be done quickly and stocks put back immediately

i i ) Pest control Pests are a serious problem in India where insects reptiles and rodents (eg cockroaches l i z a r d s r a t s s i l v e r f i s h (Deemak - in Hindi ) etc) may find access to the pharmacy storage areas Insects like ants and borer ants may often attack wood in the pharmacy causing d am ag e to shelves cupboardsPest c ontr o l in a p h a r m a c y c a n b e a d i f f i c u l t t a s k b u t t o avoid possible contamination and physical damage to stock it is necessary to keep pests out of the pharmacy premisesPest control measures should be implemented with proper p r e c a u t i o n s t a k i n g u t m o s t c a r e t o a v o i d contamination of medicines

55

Th e following pest control measures c a n be ta ke n f r om tim e to tim e -bullbullRat bait and traps can be placed at various locations bullbullInsecticutors can be used on a permanent basis bullbullInsecticidal sprays and repellants can be used from time to time

i i i ) Fire precautions

Combustible trash such as cartons boxes and other packing waste must not be allowed to accumulate in the store Waste should be deposited in appropriate waste bins and be d i s p o s e d o f f o n a d a i l y b a s i s

F i re detection and fire fighting equipment must be maintained and regularly inspected The pharmacy personnel should receive adequate training in fire fighting techniques and emergency actionFire prevention measures should include a prominently displayed ldquoNoSmokingrdquo sign careful handling and disposal of combustible waste materials and checking of electrical connections at regular intervals

iv) Security middot Doors shutters of the pharmacy should be strong and be fitted with secure locks middot Counters should be designed so that unauthorized personnelclients do not have

access to areas where prescription medicines are stored Access to such areas should be restricted to the pharmacy staff

middot All the pharmacy staff handling supplies should be accountable for their ac t i o n s

56

middot bullSpecial care must be taken in case of Schedule X and manufactured drugs (under NDPS Act) Such medicines should be kept under lock and key and the key should be kept with the Chief Pharmacist or i n h i s a b s e n c e t h e s e n i o r p h a r m a c i s t

v) Breakagespillage and damaged product Products that have been damagedspoiled during storage and handling spillages and broken glassware should be disposed off according to procedures laid down by the pharmacy Broken and damaged products s h o u l d b e p l a c e d i n a segregated area to be returned to the supplier

vi) Inspection Senior staff should inspect all pharmacy areas regularly The shelves and drawers should b e c h e c k e d d a i l y f o r signs of pests and dust Ceiling and walls should be checked for dirt and cobwebs Stock should be checked on a regular basis for deterioration due to climatic conditions

43 Product recalls Products found to be defective should be quickly recalled (withdrawn from the market) The instructions are generally issued either by the manufacturer or the regulatory agency The level of recall is determined by both the degree of risk and the extent of distribution of the product and in India is mainly directed at the distribution chain

On receiving the details of the defective substandard spurious batchbatches of a medicine to be recalled from the manufacturer or the stockist or the FDA the pharmacy should immediately check if the particular b a t c h i s i n s t o c k a n d i f s o s u s p e n d i t s s a l e immediately

Similarly if the regulatory authority in the country bans a particular medicine or FDC the pharmacy should immediately check and remove all the different brands of that particular medicine under consideration

The details of medicines and their batches to be recalled should be available in the q u a r a n t i n e a r e a w h e r e stocks are received and checked This is to ensure that such medicines do not come into the pharmacy

middot The pharmacy should develop SOPs for recall of medicines middot The pharmacy staff should be immediately informed about such medicines and

the details should be displayed in writing in a prominent place in the pharmacy middot Rapid action helps avoid unnecessary exposure to such medicines once the

problem has been d e t e c t e d middot The progress of the recall procedure in the pharmacy should be monitored every

few days to ensure complete compliance middot All stocks of the recalled products should be stored separately from the saleable

stock These can be stored in the expiry cupboard segregated from the expired goods and be appropriately labeled ldquoRecal l e d G o o d s - Not for Salerdquo

The supplier should be notified and asked to replace defective products middot All the details of the procedures followed should be duly recorded in a Recall

Register maintained specially for the purpose The register should include d etails such as -middot Date of the recall middot Nam e of the product

57

bullbull

middot Details of the product (name of manufacturer batch number expiry date) middot Nu m b er of units purchased sold a n d sto c k in ha nd middot Reason for recall middot Nam e of the supplier to whom produc ts w e r e returned along with the date and quantity middot Name and signature of the designated personnel carrying out the recall procedure and recording details middot Name and signature of the chief pharmacist verifying the recall procedures and recording details 4 4 Returned medicines

Medicines may be returned to the pharmacy by clients due to the following reasons -bull

bullbull Unused medicines bullbull Course not completed bullbull Therapy changed by doctor bullbull Side effects experienced by patient bull

bullbull DamagedDefective medicines bullbull Missing or defaced label bullbull Missing tablets in a stripblister bullbull Leakage in bottles bullbull Leakage in strips bull

bullbull Expired medicines

Appropriate SOPs should be framed and followed for their acceptancerefusal and disposal middot bull For unused medicines returned by clients the p harmacy personnel should verify

that these were purchased from their pharmacy They should then be checked for integrity of the packing the dosage form and the expiry date and verified with the client whether they were stored in appropriate conditions This again is at the discretion of each pharmacy

middot The damageddefective medicines returned to the pharmacy should be taken back and stored separately Existing stock of the same product should be checked for similar defects

middot Expired medicines should be accepted from clients at the discretion of the pharmacist and be immediately shifted to the expired goods cupboard These can be stored segregated from the pharmacys own expired goods and be appropriately labelled ldquoExpired Goods returned by clients- Not For Salerdquo

It is advisable not to accept returned medicines requiring cold chain storage (refrigeration) because it cannot be ensured that the cold chain was maintained when the medicines were in the hands of the patientclient middot Appropriate adjustments in t he stocks should be made for medicines

returnedexchanged to update the inventory middot The medicines should then be returned to the respective shelves middot A lsquoReturned Goodsrsquo register needs to be maintained to record all details of returned

medicines

R egister should include such details as-

58

middot N a m e o f t h e p a t i e n t middot Nam e of the product and quantity r e tu r n e d middot Product details such as the batch number and expiry date middot Condition in which received middot Reason for returning products middot Compensatory measures taken wi t h r e s p e c t t o c l i e n t middot Action taken with respect to product middot Name and signature of the personnel accepting the returned medicines and recording details middot Name and signature of the chief pharmacist verifying the recorded details

What the pharmacist would have learnt from this module The storage of medicines is a critical factor in the distribution cycle bullbull Stocks received by the pharmacy should be quarantined in a separate area and necessary checks s h o u ld be performed to ascertain the qua lity a nd quantity of stocks received bullbull Whatever pattern and means of storage used the products should be stored so as to maintain their potency and integrity bullbull Storage conditions should be monitored and maintained on a regular basis bullbull Optimum stock levels should be maintained and regularly monitored for expiry bullbull The design of storage areas should facilitate appropriate storage of medicines bullbull Cleanliness should be maintained in the pharmacy bullbull Adequate measures should be taken in case of returned medicines and recalled products

Optimum storage of medicines is mandatory whether at the distribution stage at the pharmacy or ultimately within the homes of patients The pharmacist has an important r o l e t o p l a y i n t h e s t o r a g e o f m e d i c i n e s i n m a i n t a i n i n g d r u g p o t ency and efficacy and thus facilitating optimum therapeutic benefits Good Pharmacy Practice - IPA -CDSCO - WHO Appendix I Quality Assurance Templates of letters for use if found not of Standard Quality [Frozen and expired goods ]

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated To Name of the Supplier with address

Sub Not of Standard Quality GoMP-Supply of Drugs and medicines-(Codename) Return of Stocks to the Suppliers-reg(New drug policy 2009) Previous letterinvoice ref Sl No Drug Code Drug name

Manufacturing date Expiry date

Supplier address

B a t c h n o

The above items of PO nodated was drawn by the Drug Inspector (Place) on (______________date) as a statutory sampling and declared ldquoNot of Standard

59

Qualityrdquo on -(______________date) by the Government Analyst for the following reasons

- ldquoThe product sample do not confirm to IP specification for (Drug codename with respect to the content of drugrdquo

- ldquoThe product has already been blacklisted by TNMSC on -(______________date) for the failure of (quantity) of batches of drug codenamerdquo

As per the clause of the te nde r d oc um e nt ldquo I f the sa mple s d o not c onf o r m to statutory standardsthe tenderer will be liable for relevant action under the existing laws and the entire stock in such batch should be taken back by the tenderer within a period of 30 days o f t h e r e c e i p t o f t h e l e t t e r f r o m t h e v e n u e

The stock shall be taken back at the expenses of the tendererthe Procurement Authority have the right to destroy such Not of Standard Quality if the tenderer does not take back the goods within the stipulated time

The Procuring Authority will arrange to destroy the Not of Standard Quality drugs within 90 days after the expiry of 30 days mentioned above without further notice and shall also collect demurrage charges calculated at the rate of 2 per week on the value of the drugs rejected till such destructionrdquo

Hence we regret to inform you that you will have to take back the stocks available of the abovesaid batch at your own cost from the drug stores where you have supplied the above batch

Kindly acknowledge the receipt of this reference at once

P r o c u r e m e n t A u t h o r i t y Seal and Stamp

Copy to Ref No dated

1 ) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated13082010

To

Sub Frozen Drugs-ordered to return to the Suppliers-reg(New drug policy 2009) Previous letterinvoice ref

The following products which were earlier frozen have now been ordered to return to suppliers directly with permission from the State drug Authority In this regard the suppliers have been instructed to take back their failed batch from the drug store of the stores Hence you are now instructed to return the following failed batches to the suppliers by obtaining proper authorization letter and acknowledgements from them

60

Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

Kindly acknowledge the receipt of this reference at once

Procurement Authority Seal and Stamp

Copy to

Ref No dated 2) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated14092010

To

Sub Frozen Drugs-ordered to return to the Suppliers- for issue of gate pass after verification reg(New drug policy 2009) Previous letterinvoice ref

The following products which were earlier frozen have now been released Hence they may be issued Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

Kindly acknowledge the receipt of this reference at once

Procurement Authority Seal and Stamp

Copy to

61

Ref No dated 3) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated

To

Sub Stop instruction-reg(New drug policy 2009) Previous letterinvoice ref

Until further instructions stop issue all the batches of the following item Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

You must intimate the available stock in the stores of the said batch Number to the Procurement Authority immediately Also retrieve quantity if already issued

Procurement Authority Seal and Stamp

Copy to

Ref No dated 4) HOD Procurement Office of

62

Appendix II Material handling in drug stores

Rack approx rates and dimensions

S No

Item Description UOM Approx Rate

1 MEDIUM DUTY RACK SIZE 2900 H X 3090 W X 800 D IN MM (AS PER SPECIFICATION)

Each 2499800

2 MEDIUM DUTY RACK ADD ON UNIT FOR SIZE OF SR NO2

Each 2243100

To locate a Box no 3 Rack no 14 in row3

SAMPLE OF RACK no Bin numbering -------------- S a y R K 1 4 R o w 3 B o x 1 6

SAMPLE LAYOUT of RACKS in a Drug Stores

63

Sample of another warehouse of distribution warehouse system

64

65

Slotted Angle racks with bin cards

66

Plastic Pallets

Plastic pallets ar e l i g h t w e i g h t l o w- c ost and exceed industry standards for strength and durability

NOTE A pallet has bottom deckboards (see sketch) A skid does not have bottom

67

deckboards

Battery Operated Stacker

Electric Stacker Ehh (Manual Push Type) - Manual drive - Lifting electrically with Battery 12 V 88 Ah - For loading and un-loading of trucks - Battery and loading device built - in - Battery charge gauge and charging current gauge Simple and Easy Operation - Lifting and Lowering electrically direct on steering arm - Pulling and pushing through steering arm - Electrically operated relief valve on hydraulic aggregate Safe Operation - Emergency Off Switch - Constant lowering speed - Protection through lowering brake valve - Overload protection through overload brake valve - Load chains covered preventing pinching threat - Electrically interlocking during loading process - Secured battery compartment opens upwardly - Stable buffering of the steering arm in upright position - In accordance with EWG Guidelines 89 240 - In accordance with VBG 12b Prevention of Accidents

Pallet Truck [ Top ]

68

----------------------------------------------------------------------------------------------------------------------------

For Transport Of All Goods On Pallets Safe and Easy Operation - through single hand operation Lifting moving

lowering with steering handle - neutral position of the hydraulic possible - overload pressure relief valve Long Service Life - robust co n s t r u c t i o n

- special hardened axles - hardened chromium plated ram - maintenance free Easy Maneuverability - through rubber steering rollers - nylon fork rollers

A h a n d t r o l l e y

69

Trolley with plastic bins for several items del ivery

70

Digital Weighing balances

Balances amp Scales EF Seriers Precision Electronic Balance

71

1

Ice lined Refrigerators

600 litres refrigrator

72

Walk in cooler

vacuum cleaner

73

including refrigerators should be recorded at a predetermined periodicity usually daily at the hottest time of the day and such documents should be preserved i i i ) Storage conditions A number of storage conditions are mentioned on the labels of medicinal products These conditions have to be properly interpreted and appropriately complied with

According to the Drugs and Cosmetics Rules 1945

1 The term cool place means a place having a temperature between 10 C and 25 C

2 The term cold place means a place having a temperature not exceeding 8 C In case of storage conditions for specific products please refer to Schedule P The Drugs and Cosmetic Rules 1 9 4 5

The Indian Pharmacopoeia specifies the following storage conditions -

Wherever the condition for storage is not specified medicines may be stored under normal temperature In a country like India however where normal temperatures soar to h i gh temperatures it is recommended that medicines be stored in a cool place

Activity Prepare a list of the storage requirements mentioned on the label of about 20 products in your pharmacy and check if the temperature is maintained

47

25 Special Storage o f s u p p l i e s If the product has no special instructions normal storage conditions apply This means storage in dry clean w e l l -ventilated premises at temperatures of +15 C to +25 C or depending on the climate up to +30 C (WHO1990) Storage instructions are product specific Different brands of the same generic drug may have different storage requirements as they may have different packaging or formulations It is essential to follow the product manufacturers storage instructions to the maximum extent possible Less stable medicines must be stored in specific conditions to maintain their quality or potency

The following products require special storage facilities

middot Products that must be kept frozen (usually vaccines and sera) middot Products sensitive to h eat an d r e q uir in g r e f r ig e r a tio n ( +2 C to +8 C) middot Products that have reduced shelf life at uncontrolled room temperature and need

mechanical ventilation or air conditioning middot Flammable products that require separate fireproof premises middot Products prone to theft o r m i s u s e

Products needing storage in a controlled environment -

The usable shelf life of the following products may be reduced if stored at uncontrolled humidity or at room temperature in hot climates -

middot Some injectables (eg adrenaline) Most injectable preparations are less stable than solid oral forms (tablets and capsules) Injectable preparations in solution are particularly unstable Many injections must be protected from light as well as heat

middot Intravenous fluids (particularly if packed in p lastic containers) middot Some suppositories pessaries creams and ointments These products may melt at

temperatures greater than 30 C Once this happens it is not advisable to use them because the active ingredient in the formula may get unevenly distributed

middot Products containing rubber latex cellulose or some plastics Condoms most sterile disposable medical devices and surgical products such as syringes needles and catheters require protection from excessive humidity and strong light and heat Any o f these conditions may make products brittle stained amp unusable Sterility cannot be assumed if packaging is damaged

In hot climates these products should be stored in the coolest place possible preferably with air conditioning or air circulation fans

48

Products needing freezing or refrigeration-middot Vaccines blood products and many other medicines lose potency if kept even for a

brief period at temperatures outside the recommended range For these products the cold chain must be maintained at every stage of the distribution system

middot Freezing is as damaging as high temperatures for some products including injectable contraceptives ergometrine insulin adrenaline and the DPT DT TT and Hepatitis B vaccines Such products therefore sho uld not be allowed to freeze (not be kept in the freezer compartment)

middot Short periods at room temperature (during transportation or local distribution for instance) may be acceptable for many products (such as ergometrine a n d i n s u l i n ) e v e n t h o u g h s u c h e x posure can to some extent reduce shelf life Other items such as vaccines should always be transported in cold boxes

Storage of insulin injections-

middot Insulin should always be stored in a refrigerator at the recommended temperature of 2 -8 C

middot Insulin should not be kept in the freezer compartment of the refrigerator middot Insulin should ideally be stored horizontally middot It should not be exposed to sunlight or excessive heat middot Insulin suspensions should not be used if the suspension cannot be properly

resuspended due to cake or clump formationbull

Controlled drugs -Narcotics (for example Pethidine injection morphine preparations) and other specified drugs that may be abused are governed by special legislation and regulations The following security measures are suggested in the pharmacy -middot A safe or reinforced double locked cabinet fitted with a light (preferably with a red

bulb) that comes on when the door is opened

49

middot A special register recording details of each receipt or issue with 2 signatures physi cal counting of medicines after each entry and signatures at handover takeover

middot Independent audit (by supervisors and drug inspectors)

Products prone to theft abuse or misuse -

Some medicinesproducts are particularly prone to theft abuse or misuse These include expensive medicines (eg insulin) certain antibiotics and products prone to abuse or misuse like psychotropics etc

Such medicinesproducts should be stored adequately They require stricter record keeping and more frequent stock taki ng than others Periodic audits should be carried out to check for consumption against actual recorded use (registers prescription records stock records etc) to expose any theft or misuse bull26 Storage and stability of medicines Medicines are not stab le indefinitely They are stable for a specific period of time sometimes for a brief period Poor storage conditions accelerate the drug degradation (decomposition) Temperature light and moisture are the most important contributing factors for drug instability It is important to identify and be aware of the potential for instability There is a need to comply with storage requirements to ensure quality medicines for patients It is also important to offer advice to patients too about appropriate storage o f medicines at home The dispensing label should state the storage condition required and be backed up by a verbal reminder especially where special storage is required bull

50

In case stability and storage problems are seen with formulations they should be reported immediately to the representative of the manufacturer and taken out of circulation till the stability problems have been resolved

The pharmacist can easily detect stability problems when products show change in appearance color odor settling of the product contents breaking of emulsions melting of creams oozing of contents from the containers and any such physical changes

3 STOCK CONTROL AND EXPIRY MONITORING 3 1 S t o c k C o n t r o l For economic reasons pharmacists do not like to have stock on their shelves for long periods of time The aim should always be to keep stock at a level that will just meet demand Normally most manufactured medicines have a long shelf life Even then it is essential that there is efficient stock rot ation so that the older stock is used first It is also a good practice to check the expiry date as an integral part of the dispensing process When short shelf life products are involved stock levels may have to be modified to prevent medicines regularl y expiring on the shelves

32 Stock rotation and expiry monitoring In order to avoid accumulation of expired and obsolete stock medicines should be stored and issued according to the following guidelines -middot The stock control system must record the ex p i r y d a t e a n d t h e d a t e o f r e c e i p t middot Stock must be stored so that earliest expiring batches are picked and issued first middot The First In First Out (FIFO) system - In this system the stock which is received

first is sold first This system however may not be useful for pharmacies because most of the stocks carry an expiry date For pharmacies the FEFO system is more practical

51

middot The First Expiry First Out (FEFO) system - In this system the stock having an earlier expiry is sold first The stock with longer shelf life should be placed farthest to the back (or at the bottom in case o f sta c k e d b oxe s) T h is is pa r tic u la r ly impor ta n t with products that have short shelf lives such as vaccines some vitamins antibiotics etc and reduces losses due to expiry

middot E x p i r y dates should be noted on the stock record upon receipt Stock nearing expiry should not be accepted unless it can be used before expiry

Computerization and expiry monitoring In the pharmacy computerization facilitates both checking stocks and expiry mo nitoring and helps-bullbullKeeping a check on products nearing expiry bullbullKeeping a check on non- moving and slow moving products bullbullTo facilitate the removal of medicines nearing expiry from shelves in time to send them back to the wholesaler or supplier

Periodic checking for expiry The expiry date for medicinal products is a critical aspect in pharmaceutical dispensing and due importance should be given to it Periodic checking for expiry of medicines will ensure that the patient will never receive products that have crossed their expiry date During periodical checking of expiry the personnel involved should remove medicines that are nearing expiry bullbullIn -house threshold periods should be set and followed for retrieval of such medicines from the shelves bullbullSuch medicines should be stored separately These should either be dispensed immediately (thus ensuring that they are used before the expiry date) o r t h e y s h o u l d b e returned to the suppliers bullbullA separate area should be designated (cupboard or shelf)marked[FROZEN ZONE] which is adequately marked EXPIRED GOODS- NOT FOR SALE to store all expired stocks FROZEN ZONE

52

Remember Expired medicines are a NATIONAL WASTE So stock only what you can sell Avoid expiries save precious medicines for the nation

Treatment and disposing of expired medicines bullbullProcedures need to be in place for the treatment of expired medicines bullbullThe expired medicines need to be collected and be sent back to the supplier or company for appropriate disposal bullbullRecords must be maintained for expired medicines and how they are disposed off bullbullIn case of medicines that are not returnable to suppliers procedures for disposal need to be followed by the pharmacy in conjunction with the FDA The following procedure can be followed if medicines cannot be returned to suppliers ( T h e b a s i c p h i l o s o p h y of appropriate disposal is to prevent their re- circulation and use) bullbullC u t t h e c o n t ainer in such a manner that the label is also cut In case of tablets and c a p s u l e s d e s t r o y them by disposing them in a bucket of water bullbullUse landfill procedures (deep burial into the ground as per stipulations of Medical Waste Disposal Act prevalent in the respective state) bullbullPour the liquids into the sink and wash away with sufficient quantity of water bullbullKeep a record of such disposal with full details of medicines destroyed Although these measures are usually adopted care has to be taken with such tr e a t m e n t a s studies have shown that flushing of medicines has resulted in tracessmall quantities of medicines being found in waterways and groundwater having potential health and environmental effects

4 O T H E R A S P E C T S 41 Design of storage areas The following important factors need to be considered in design of storage areas -middot The retail outlets in hot areas in summers should be air-conditioned Similarly in

a r e a s o f e x t r e m e c o l d t h e p r e m i s e s w o u l d r e q u i r e w a r m i n g e s p e c i a l l y i n w i n t e r s t o maintain cool temperatures The placement of air -conditioners and heating devices should be such that medicines are not directly exposed to the cold or heat

middot Due consideration should be given to storage requirements of formulations while designing shelves and cupboards in retail outlets Sufficient shelf height should be provided so that all liquid products can be stored vertically As far as possible the shelves should be covered with glass panels to protect medicines from dust and p r e v e n t r a p i d f l u c t u a t i o n s i n temperature

middot Medicines should be stored according to the storage instructions on the labels bullIt is ideal to have a door at the pharmacy entrance to prevent dust from coming in as well as reduceprevent cooled air from going out This may not however be considered feasiblepracticable by many pharmacy owners for fear that clients may not enter the pharmacy because the door may act as a barrier An air curtain is a good alternative to a door

middot There should be minimal direct sunlight falling on the products Particular consideration should be given to premises directly facing the sun

middot bullThe arrangement of lighting in the interior of the premises should also be in a manner that the lights are not focused on the products It has been shown that light causes not only chemical damage but also can catalyze physical changes like moisture uptak e by the products Care should be taken to ensure that only diffused light falls on them

53

middot As far as possible provision should be made for a temperature and humidity indicator device in a pharmacy These devices are now easily available

middot Stability studies o f m e d i c i n e s p a c k e d i n b l i s t e r s h a v e r e v e a l e d t h a t i f t h e s e a r e exposed to light they tend to absorb moisture It is therefore necessary to store them in suitable cartons so that the blisters are not exposed to light Pharmacists should do this even if the manufacturer has not provided cartons

middot Light and temperature sensitive products should not be stored on counters where the light is intense or direct and there is no protection from temperature and humidity

42 Cleaning and maintenance i) Cleaning of storage areas

The storage areas of the pharmacy should be cleaned periodically and cleanliness should be maintained at all times The Standard Operating Procedure for cleaning should be designed and followed accordingly Schedules for cleanups should be laid down and adequate cleaning equipment should be made available

Tips for maintaining cleanliness middot Provide clean pieces of cloth for wiping at various locations in the pharmacy

Replace with clean cloth at regular intervals middot Keep separate pieces of cloth for floors shelves and medicines middot Use a disinfectant andor soap solution to clean floors middot Ensure removal of dust and prevent accumulation of dirt middot Ensure removal of cobwebs middot Use a vacuum cleaner for cleaning areas not easily reachable middot T a k e c a r e t h at breakages are handled and cleared effectively middot Observe the factors leading to waste generation in the pharmacy and take appropriate

measures to tackle the problem middot Record all cleaning procedures performed and maintain all the documents required

For ex a m p l e -bullbullThe floor of the pharmacy may be swept with a broom and swabbed with soap water every morning bullbullThe floor may be swabbed with a disinfectant every week bullbullThe entire premises including shelves and cupboards may be cleaned with a cloth (to remove dust and to check for medicines approaching expiry date or expired medicines) every three months bullbullAll the steps followed should be r e c o r d e d

The floor shelves drawers have to be cleaned and a check should be kept on dust cobwebs spillages due to breakage etc It is therefore essential to have SOPs for cleaning laying down cleaning frequencies allotting responsibilities and maintaining a daily record in the logbook to document all these activities

54

While cleaning dust settled on dosage forms like bottles tubes etc should be removed Before dispensing the products should also be wiped to remove any dust settled during storage

For refrigerators bullbullDefrosting and cleaning should be done at regular intervals bullbullSwitch off the refrigerator while cleaning bullbullCleaning should be done quickly and stocks put back immediately

i i ) Pest control Pests are a serious problem in India where insects reptiles and rodents (eg cockroaches l i z a r d s r a t s s i l v e r f i s h (Deemak - in Hindi ) etc) may find access to the pharmacy storage areas Insects like ants and borer ants may often attack wood in the pharmacy causing d am ag e to shelves cupboardsPest c ontr o l in a p h a r m a c y c a n b e a d i f f i c u l t t a s k b u t t o avoid possible contamination and physical damage to stock it is necessary to keep pests out of the pharmacy premisesPest control measures should be implemented with proper p r e c a u t i o n s t a k i n g u t m o s t c a r e t o a v o i d contamination of medicines

55

Th e following pest control measures c a n be ta ke n f r om tim e to tim e -bullbullRat bait and traps can be placed at various locations bullbullInsecticutors can be used on a permanent basis bullbullInsecticidal sprays and repellants can be used from time to time

i i i ) Fire precautions

Combustible trash such as cartons boxes and other packing waste must not be allowed to accumulate in the store Waste should be deposited in appropriate waste bins and be d i s p o s e d o f f o n a d a i l y b a s i s

F i re detection and fire fighting equipment must be maintained and regularly inspected The pharmacy personnel should receive adequate training in fire fighting techniques and emergency actionFire prevention measures should include a prominently displayed ldquoNoSmokingrdquo sign careful handling and disposal of combustible waste materials and checking of electrical connections at regular intervals

iv) Security middot Doors shutters of the pharmacy should be strong and be fitted with secure locks middot Counters should be designed so that unauthorized personnelclients do not have

access to areas where prescription medicines are stored Access to such areas should be restricted to the pharmacy staff

middot All the pharmacy staff handling supplies should be accountable for their ac t i o n s

56

middot bullSpecial care must be taken in case of Schedule X and manufactured drugs (under NDPS Act) Such medicines should be kept under lock and key and the key should be kept with the Chief Pharmacist or i n h i s a b s e n c e t h e s e n i o r p h a r m a c i s t

v) Breakagespillage and damaged product Products that have been damagedspoiled during storage and handling spillages and broken glassware should be disposed off according to procedures laid down by the pharmacy Broken and damaged products s h o u l d b e p l a c e d i n a segregated area to be returned to the supplier

vi) Inspection Senior staff should inspect all pharmacy areas regularly The shelves and drawers should b e c h e c k e d d a i l y f o r signs of pests and dust Ceiling and walls should be checked for dirt and cobwebs Stock should be checked on a regular basis for deterioration due to climatic conditions

43 Product recalls Products found to be defective should be quickly recalled (withdrawn from the market) The instructions are generally issued either by the manufacturer or the regulatory agency The level of recall is determined by both the degree of risk and the extent of distribution of the product and in India is mainly directed at the distribution chain

On receiving the details of the defective substandard spurious batchbatches of a medicine to be recalled from the manufacturer or the stockist or the FDA the pharmacy should immediately check if the particular b a t c h i s i n s t o c k a n d i f s o s u s p e n d i t s s a l e immediately

Similarly if the regulatory authority in the country bans a particular medicine or FDC the pharmacy should immediately check and remove all the different brands of that particular medicine under consideration

The details of medicines and their batches to be recalled should be available in the q u a r a n t i n e a r e a w h e r e stocks are received and checked This is to ensure that such medicines do not come into the pharmacy

middot The pharmacy should develop SOPs for recall of medicines middot The pharmacy staff should be immediately informed about such medicines and

the details should be displayed in writing in a prominent place in the pharmacy middot Rapid action helps avoid unnecessary exposure to such medicines once the

problem has been d e t e c t e d middot The progress of the recall procedure in the pharmacy should be monitored every

few days to ensure complete compliance middot All stocks of the recalled products should be stored separately from the saleable

stock These can be stored in the expiry cupboard segregated from the expired goods and be appropriately labeled ldquoRecal l e d G o o d s - Not for Salerdquo

The supplier should be notified and asked to replace defective products middot All the details of the procedures followed should be duly recorded in a Recall

Register maintained specially for the purpose The register should include d etails such as -middot Date of the recall middot Nam e of the product

57

bullbull

middot Details of the product (name of manufacturer batch number expiry date) middot Nu m b er of units purchased sold a n d sto c k in ha nd middot Reason for recall middot Nam e of the supplier to whom produc ts w e r e returned along with the date and quantity middot Name and signature of the designated personnel carrying out the recall procedure and recording details middot Name and signature of the chief pharmacist verifying the recall procedures and recording details 4 4 Returned medicines

Medicines may be returned to the pharmacy by clients due to the following reasons -bull

bullbull Unused medicines bullbull Course not completed bullbull Therapy changed by doctor bullbull Side effects experienced by patient bull

bullbull DamagedDefective medicines bullbull Missing or defaced label bullbull Missing tablets in a stripblister bullbull Leakage in bottles bullbull Leakage in strips bull

bullbull Expired medicines

Appropriate SOPs should be framed and followed for their acceptancerefusal and disposal middot bull For unused medicines returned by clients the p harmacy personnel should verify

that these were purchased from their pharmacy They should then be checked for integrity of the packing the dosage form and the expiry date and verified with the client whether they were stored in appropriate conditions This again is at the discretion of each pharmacy

middot The damageddefective medicines returned to the pharmacy should be taken back and stored separately Existing stock of the same product should be checked for similar defects

middot Expired medicines should be accepted from clients at the discretion of the pharmacist and be immediately shifted to the expired goods cupboard These can be stored segregated from the pharmacys own expired goods and be appropriately labelled ldquoExpired Goods returned by clients- Not For Salerdquo

It is advisable not to accept returned medicines requiring cold chain storage (refrigeration) because it cannot be ensured that the cold chain was maintained when the medicines were in the hands of the patientclient middot Appropriate adjustments in t he stocks should be made for medicines

returnedexchanged to update the inventory middot The medicines should then be returned to the respective shelves middot A lsquoReturned Goodsrsquo register needs to be maintained to record all details of returned

medicines

R egister should include such details as-

58

middot N a m e o f t h e p a t i e n t middot Nam e of the product and quantity r e tu r n e d middot Product details such as the batch number and expiry date middot Condition in which received middot Reason for returning products middot Compensatory measures taken wi t h r e s p e c t t o c l i e n t middot Action taken with respect to product middot Name and signature of the personnel accepting the returned medicines and recording details middot Name and signature of the chief pharmacist verifying the recorded details

What the pharmacist would have learnt from this module The storage of medicines is a critical factor in the distribution cycle bullbull Stocks received by the pharmacy should be quarantined in a separate area and necessary checks s h o u ld be performed to ascertain the qua lity a nd quantity of stocks received bullbull Whatever pattern and means of storage used the products should be stored so as to maintain their potency and integrity bullbull Storage conditions should be monitored and maintained on a regular basis bullbull Optimum stock levels should be maintained and regularly monitored for expiry bullbull The design of storage areas should facilitate appropriate storage of medicines bullbull Cleanliness should be maintained in the pharmacy bullbull Adequate measures should be taken in case of returned medicines and recalled products

Optimum storage of medicines is mandatory whether at the distribution stage at the pharmacy or ultimately within the homes of patients The pharmacist has an important r o l e t o p l a y i n t h e s t o r a g e o f m e d i c i n e s i n m a i n t a i n i n g d r u g p o t ency and efficacy and thus facilitating optimum therapeutic benefits Good Pharmacy Practice - IPA -CDSCO - WHO Appendix I Quality Assurance Templates of letters for use if found not of Standard Quality [Frozen and expired goods ]

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated To Name of the Supplier with address

Sub Not of Standard Quality GoMP-Supply of Drugs and medicines-(Codename) Return of Stocks to the Suppliers-reg(New drug policy 2009) Previous letterinvoice ref Sl No Drug Code Drug name

Manufacturing date Expiry date

Supplier address

B a t c h n o

The above items of PO nodated was drawn by the Drug Inspector (Place) on (______________date) as a statutory sampling and declared ldquoNot of Standard

59

Qualityrdquo on -(______________date) by the Government Analyst for the following reasons

- ldquoThe product sample do not confirm to IP specification for (Drug codename with respect to the content of drugrdquo

- ldquoThe product has already been blacklisted by TNMSC on -(______________date) for the failure of (quantity) of batches of drug codenamerdquo

As per the clause of the te nde r d oc um e nt ldquo I f the sa mple s d o not c onf o r m to statutory standardsthe tenderer will be liable for relevant action under the existing laws and the entire stock in such batch should be taken back by the tenderer within a period of 30 days o f t h e r e c e i p t o f t h e l e t t e r f r o m t h e v e n u e

The stock shall be taken back at the expenses of the tendererthe Procurement Authority have the right to destroy such Not of Standard Quality if the tenderer does not take back the goods within the stipulated time

The Procuring Authority will arrange to destroy the Not of Standard Quality drugs within 90 days after the expiry of 30 days mentioned above without further notice and shall also collect demurrage charges calculated at the rate of 2 per week on the value of the drugs rejected till such destructionrdquo

Hence we regret to inform you that you will have to take back the stocks available of the abovesaid batch at your own cost from the drug stores where you have supplied the above batch

Kindly acknowledge the receipt of this reference at once

P r o c u r e m e n t A u t h o r i t y Seal and Stamp

Copy to Ref No dated

1 ) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated13082010

To

Sub Frozen Drugs-ordered to return to the Suppliers-reg(New drug policy 2009) Previous letterinvoice ref

The following products which were earlier frozen have now been ordered to return to suppliers directly with permission from the State drug Authority In this regard the suppliers have been instructed to take back their failed batch from the drug store of the stores Hence you are now instructed to return the following failed batches to the suppliers by obtaining proper authorization letter and acknowledgements from them

60

Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

Kindly acknowledge the receipt of this reference at once

Procurement Authority Seal and Stamp

Copy to

Ref No dated 2) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated14092010

To

Sub Frozen Drugs-ordered to return to the Suppliers- for issue of gate pass after verification reg(New drug policy 2009) Previous letterinvoice ref

The following products which were earlier frozen have now been released Hence they may be issued Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

Kindly acknowledge the receipt of this reference at once

Procurement Authority Seal and Stamp

Copy to

61

Ref No dated 3) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated

To

Sub Stop instruction-reg(New drug policy 2009) Previous letterinvoice ref

Until further instructions stop issue all the batches of the following item Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

You must intimate the available stock in the stores of the said batch Number to the Procurement Authority immediately Also retrieve quantity if already issued

Procurement Authority Seal and Stamp

Copy to

Ref No dated 4) HOD Procurement Office of

62

Appendix II Material handling in drug stores

Rack approx rates and dimensions

S No

Item Description UOM Approx Rate

1 MEDIUM DUTY RACK SIZE 2900 H X 3090 W X 800 D IN MM (AS PER SPECIFICATION)

Each 2499800

2 MEDIUM DUTY RACK ADD ON UNIT FOR SIZE OF SR NO2

Each 2243100

To locate a Box no 3 Rack no 14 in row3

SAMPLE OF RACK no Bin numbering -------------- S a y R K 1 4 R o w 3 B o x 1 6

SAMPLE LAYOUT of RACKS in a Drug Stores

63

Sample of another warehouse of distribution warehouse system

64

65

Slotted Angle racks with bin cards

66

Plastic Pallets

Plastic pallets ar e l i g h t w e i g h t l o w- c ost and exceed industry standards for strength and durability

NOTE A pallet has bottom deckboards (see sketch) A skid does not have bottom

67

deckboards

Battery Operated Stacker

Electric Stacker Ehh (Manual Push Type) - Manual drive - Lifting electrically with Battery 12 V 88 Ah - For loading and un-loading of trucks - Battery and loading device built - in - Battery charge gauge and charging current gauge Simple and Easy Operation - Lifting and Lowering electrically direct on steering arm - Pulling and pushing through steering arm - Electrically operated relief valve on hydraulic aggregate Safe Operation - Emergency Off Switch - Constant lowering speed - Protection through lowering brake valve - Overload protection through overload brake valve - Load chains covered preventing pinching threat - Electrically interlocking during loading process - Secured battery compartment opens upwardly - Stable buffering of the steering arm in upright position - In accordance with EWG Guidelines 89 240 - In accordance with VBG 12b Prevention of Accidents

Pallet Truck [ Top ]

68

----------------------------------------------------------------------------------------------------------------------------

For Transport Of All Goods On Pallets Safe and Easy Operation - through single hand operation Lifting moving

lowering with steering handle - neutral position of the hydraulic possible - overload pressure relief valve Long Service Life - robust co n s t r u c t i o n

- special hardened axles - hardened chromium plated ram - maintenance free Easy Maneuverability - through rubber steering rollers - nylon fork rollers

A h a n d t r o l l e y

69

Trolley with plastic bins for several items del ivery

70

Digital Weighing balances

Balances amp Scales EF Seriers Precision Electronic Balance

71

1

Ice lined Refrigerators

600 litres refrigrator

72

Walk in cooler

vacuum cleaner

73

25 Special Storage o f s u p p l i e s If the product has no special instructions normal storage conditions apply This means storage in dry clean w e l l -ventilated premises at temperatures of +15 C to +25 C or depending on the climate up to +30 C (WHO1990) Storage instructions are product specific Different brands of the same generic drug may have different storage requirements as they may have different packaging or formulations It is essential to follow the product manufacturers storage instructions to the maximum extent possible Less stable medicines must be stored in specific conditions to maintain their quality or potency

The following products require special storage facilities

middot Products that must be kept frozen (usually vaccines and sera) middot Products sensitive to h eat an d r e q uir in g r e f r ig e r a tio n ( +2 C to +8 C) middot Products that have reduced shelf life at uncontrolled room temperature and need

mechanical ventilation or air conditioning middot Flammable products that require separate fireproof premises middot Products prone to theft o r m i s u s e

Products needing storage in a controlled environment -

The usable shelf life of the following products may be reduced if stored at uncontrolled humidity or at room temperature in hot climates -

middot Some injectables (eg adrenaline) Most injectable preparations are less stable than solid oral forms (tablets and capsules) Injectable preparations in solution are particularly unstable Many injections must be protected from light as well as heat

middot Intravenous fluids (particularly if packed in p lastic containers) middot Some suppositories pessaries creams and ointments These products may melt at

temperatures greater than 30 C Once this happens it is not advisable to use them because the active ingredient in the formula may get unevenly distributed

middot Products containing rubber latex cellulose or some plastics Condoms most sterile disposable medical devices and surgical products such as syringes needles and catheters require protection from excessive humidity and strong light and heat Any o f these conditions may make products brittle stained amp unusable Sterility cannot be assumed if packaging is damaged

In hot climates these products should be stored in the coolest place possible preferably with air conditioning or air circulation fans

48

Products needing freezing or refrigeration-middot Vaccines blood products and many other medicines lose potency if kept even for a

brief period at temperatures outside the recommended range For these products the cold chain must be maintained at every stage of the distribution system

middot Freezing is as damaging as high temperatures for some products including injectable contraceptives ergometrine insulin adrenaline and the DPT DT TT and Hepatitis B vaccines Such products therefore sho uld not be allowed to freeze (not be kept in the freezer compartment)

middot Short periods at room temperature (during transportation or local distribution for instance) may be acceptable for many products (such as ergometrine a n d i n s u l i n ) e v e n t h o u g h s u c h e x posure can to some extent reduce shelf life Other items such as vaccines should always be transported in cold boxes

Storage of insulin injections-

middot Insulin should always be stored in a refrigerator at the recommended temperature of 2 -8 C

middot Insulin should not be kept in the freezer compartment of the refrigerator middot Insulin should ideally be stored horizontally middot It should not be exposed to sunlight or excessive heat middot Insulin suspensions should not be used if the suspension cannot be properly

resuspended due to cake or clump formationbull

Controlled drugs -Narcotics (for example Pethidine injection morphine preparations) and other specified drugs that may be abused are governed by special legislation and regulations The following security measures are suggested in the pharmacy -middot A safe or reinforced double locked cabinet fitted with a light (preferably with a red

bulb) that comes on when the door is opened

49

middot A special register recording details of each receipt or issue with 2 signatures physi cal counting of medicines after each entry and signatures at handover takeover

middot Independent audit (by supervisors and drug inspectors)

Products prone to theft abuse or misuse -

Some medicinesproducts are particularly prone to theft abuse or misuse These include expensive medicines (eg insulin) certain antibiotics and products prone to abuse or misuse like psychotropics etc

Such medicinesproducts should be stored adequately They require stricter record keeping and more frequent stock taki ng than others Periodic audits should be carried out to check for consumption against actual recorded use (registers prescription records stock records etc) to expose any theft or misuse bull26 Storage and stability of medicines Medicines are not stab le indefinitely They are stable for a specific period of time sometimes for a brief period Poor storage conditions accelerate the drug degradation (decomposition) Temperature light and moisture are the most important contributing factors for drug instability It is important to identify and be aware of the potential for instability There is a need to comply with storage requirements to ensure quality medicines for patients It is also important to offer advice to patients too about appropriate storage o f medicines at home The dispensing label should state the storage condition required and be backed up by a verbal reminder especially where special storage is required bull

50

In case stability and storage problems are seen with formulations they should be reported immediately to the representative of the manufacturer and taken out of circulation till the stability problems have been resolved

The pharmacist can easily detect stability problems when products show change in appearance color odor settling of the product contents breaking of emulsions melting of creams oozing of contents from the containers and any such physical changes

3 STOCK CONTROL AND EXPIRY MONITORING 3 1 S t o c k C o n t r o l For economic reasons pharmacists do not like to have stock on their shelves for long periods of time The aim should always be to keep stock at a level that will just meet demand Normally most manufactured medicines have a long shelf life Even then it is essential that there is efficient stock rot ation so that the older stock is used first It is also a good practice to check the expiry date as an integral part of the dispensing process When short shelf life products are involved stock levels may have to be modified to prevent medicines regularl y expiring on the shelves

32 Stock rotation and expiry monitoring In order to avoid accumulation of expired and obsolete stock medicines should be stored and issued according to the following guidelines -middot The stock control system must record the ex p i r y d a t e a n d t h e d a t e o f r e c e i p t middot Stock must be stored so that earliest expiring batches are picked and issued first middot The First In First Out (FIFO) system - In this system the stock which is received

first is sold first This system however may not be useful for pharmacies because most of the stocks carry an expiry date For pharmacies the FEFO system is more practical

51

middot The First Expiry First Out (FEFO) system - In this system the stock having an earlier expiry is sold first The stock with longer shelf life should be placed farthest to the back (or at the bottom in case o f sta c k e d b oxe s) T h is is pa r tic u la r ly impor ta n t with products that have short shelf lives such as vaccines some vitamins antibiotics etc and reduces losses due to expiry

middot E x p i r y dates should be noted on the stock record upon receipt Stock nearing expiry should not be accepted unless it can be used before expiry

Computerization and expiry monitoring In the pharmacy computerization facilitates both checking stocks and expiry mo nitoring and helps-bullbullKeeping a check on products nearing expiry bullbullKeeping a check on non- moving and slow moving products bullbullTo facilitate the removal of medicines nearing expiry from shelves in time to send them back to the wholesaler or supplier

Periodic checking for expiry The expiry date for medicinal products is a critical aspect in pharmaceutical dispensing and due importance should be given to it Periodic checking for expiry of medicines will ensure that the patient will never receive products that have crossed their expiry date During periodical checking of expiry the personnel involved should remove medicines that are nearing expiry bullbullIn -house threshold periods should be set and followed for retrieval of such medicines from the shelves bullbullSuch medicines should be stored separately These should either be dispensed immediately (thus ensuring that they are used before the expiry date) o r t h e y s h o u l d b e returned to the suppliers bullbullA separate area should be designated (cupboard or shelf)marked[FROZEN ZONE] which is adequately marked EXPIRED GOODS- NOT FOR SALE to store all expired stocks FROZEN ZONE

52

Remember Expired medicines are a NATIONAL WASTE So stock only what you can sell Avoid expiries save precious medicines for the nation

Treatment and disposing of expired medicines bullbullProcedures need to be in place for the treatment of expired medicines bullbullThe expired medicines need to be collected and be sent back to the supplier or company for appropriate disposal bullbullRecords must be maintained for expired medicines and how they are disposed off bullbullIn case of medicines that are not returnable to suppliers procedures for disposal need to be followed by the pharmacy in conjunction with the FDA The following procedure can be followed if medicines cannot be returned to suppliers ( T h e b a s i c p h i l o s o p h y of appropriate disposal is to prevent their re- circulation and use) bullbullC u t t h e c o n t ainer in such a manner that the label is also cut In case of tablets and c a p s u l e s d e s t r o y them by disposing them in a bucket of water bullbullUse landfill procedures (deep burial into the ground as per stipulations of Medical Waste Disposal Act prevalent in the respective state) bullbullPour the liquids into the sink and wash away with sufficient quantity of water bullbullKeep a record of such disposal with full details of medicines destroyed Although these measures are usually adopted care has to be taken with such tr e a t m e n t a s studies have shown that flushing of medicines has resulted in tracessmall quantities of medicines being found in waterways and groundwater having potential health and environmental effects

4 O T H E R A S P E C T S 41 Design of storage areas The following important factors need to be considered in design of storage areas -middot The retail outlets in hot areas in summers should be air-conditioned Similarly in

a r e a s o f e x t r e m e c o l d t h e p r e m i s e s w o u l d r e q u i r e w a r m i n g e s p e c i a l l y i n w i n t e r s t o maintain cool temperatures The placement of air -conditioners and heating devices should be such that medicines are not directly exposed to the cold or heat

middot Due consideration should be given to storage requirements of formulations while designing shelves and cupboards in retail outlets Sufficient shelf height should be provided so that all liquid products can be stored vertically As far as possible the shelves should be covered with glass panels to protect medicines from dust and p r e v e n t r a p i d f l u c t u a t i o n s i n temperature

middot Medicines should be stored according to the storage instructions on the labels bullIt is ideal to have a door at the pharmacy entrance to prevent dust from coming in as well as reduceprevent cooled air from going out This may not however be considered feasiblepracticable by many pharmacy owners for fear that clients may not enter the pharmacy because the door may act as a barrier An air curtain is a good alternative to a door

middot There should be minimal direct sunlight falling on the products Particular consideration should be given to premises directly facing the sun

middot bullThe arrangement of lighting in the interior of the premises should also be in a manner that the lights are not focused on the products It has been shown that light causes not only chemical damage but also can catalyze physical changes like moisture uptak e by the products Care should be taken to ensure that only diffused light falls on them

53

middot As far as possible provision should be made for a temperature and humidity indicator device in a pharmacy These devices are now easily available

middot Stability studies o f m e d i c i n e s p a c k e d i n b l i s t e r s h a v e r e v e a l e d t h a t i f t h e s e a r e exposed to light they tend to absorb moisture It is therefore necessary to store them in suitable cartons so that the blisters are not exposed to light Pharmacists should do this even if the manufacturer has not provided cartons

middot Light and temperature sensitive products should not be stored on counters where the light is intense or direct and there is no protection from temperature and humidity

42 Cleaning and maintenance i) Cleaning of storage areas

The storage areas of the pharmacy should be cleaned periodically and cleanliness should be maintained at all times The Standard Operating Procedure for cleaning should be designed and followed accordingly Schedules for cleanups should be laid down and adequate cleaning equipment should be made available

Tips for maintaining cleanliness middot Provide clean pieces of cloth for wiping at various locations in the pharmacy

Replace with clean cloth at regular intervals middot Keep separate pieces of cloth for floors shelves and medicines middot Use a disinfectant andor soap solution to clean floors middot Ensure removal of dust and prevent accumulation of dirt middot Ensure removal of cobwebs middot Use a vacuum cleaner for cleaning areas not easily reachable middot T a k e c a r e t h at breakages are handled and cleared effectively middot Observe the factors leading to waste generation in the pharmacy and take appropriate

measures to tackle the problem middot Record all cleaning procedures performed and maintain all the documents required

For ex a m p l e -bullbullThe floor of the pharmacy may be swept with a broom and swabbed with soap water every morning bullbullThe floor may be swabbed with a disinfectant every week bullbullThe entire premises including shelves and cupboards may be cleaned with a cloth (to remove dust and to check for medicines approaching expiry date or expired medicines) every three months bullbullAll the steps followed should be r e c o r d e d

The floor shelves drawers have to be cleaned and a check should be kept on dust cobwebs spillages due to breakage etc It is therefore essential to have SOPs for cleaning laying down cleaning frequencies allotting responsibilities and maintaining a daily record in the logbook to document all these activities

54

While cleaning dust settled on dosage forms like bottles tubes etc should be removed Before dispensing the products should also be wiped to remove any dust settled during storage

For refrigerators bullbullDefrosting and cleaning should be done at regular intervals bullbullSwitch off the refrigerator while cleaning bullbullCleaning should be done quickly and stocks put back immediately

i i ) Pest control Pests are a serious problem in India where insects reptiles and rodents (eg cockroaches l i z a r d s r a t s s i l v e r f i s h (Deemak - in Hindi ) etc) may find access to the pharmacy storage areas Insects like ants and borer ants may often attack wood in the pharmacy causing d am ag e to shelves cupboardsPest c ontr o l in a p h a r m a c y c a n b e a d i f f i c u l t t a s k b u t t o avoid possible contamination and physical damage to stock it is necessary to keep pests out of the pharmacy premisesPest control measures should be implemented with proper p r e c a u t i o n s t a k i n g u t m o s t c a r e t o a v o i d contamination of medicines

55

Th e following pest control measures c a n be ta ke n f r om tim e to tim e -bullbullRat bait and traps can be placed at various locations bullbullInsecticutors can be used on a permanent basis bullbullInsecticidal sprays and repellants can be used from time to time

i i i ) Fire precautions

Combustible trash such as cartons boxes and other packing waste must not be allowed to accumulate in the store Waste should be deposited in appropriate waste bins and be d i s p o s e d o f f o n a d a i l y b a s i s

F i re detection and fire fighting equipment must be maintained and regularly inspected The pharmacy personnel should receive adequate training in fire fighting techniques and emergency actionFire prevention measures should include a prominently displayed ldquoNoSmokingrdquo sign careful handling and disposal of combustible waste materials and checking of electrical connections at regular intervals

iv) Security middot Doors shutters of the pharmacy should be strong and be fitted with secure locks middot Counters should be designed so that unauthorized personnelclients do not have

access to areas where prescription medicines are stored Access to such areas should be restricted to the pharmacy staff

middot All the pharmacy staff handling supplies should be accountable for their ac t i o n s

56

middot bullSpecial care must be taken in case of Schedule X and manufactured drugs (under NDPS Act) Such medicines should be kept under lock and key and the key should be kept with the Chief Pharmacist or i n h i s a b s e n c e t h e s e n i o r p h a r m a c i s t

v) Breakagespillage and damaged product Products that have been damagedspoiled during storage and handling spillages and broken glassware should be disposed off according to procedures laid down by the pharmacy Broken and damaged products s h o u l d b e p l a c e d i n a segregated area to be returned to the supplier

vi) Inspection Senior staff should inspect all pharmacy areas regularly The shelves and drawers should b e c h e c k e d d a i l y f o r signs of pests and dust Ceiling and walls should be checked for dirt and cobwebs Stock should be checked on a regular basis for deterioration due to climatic conditions

43 Product recalls Products found to be defective should be quickly recalled (withdrawn from the market) The instructions are generally issued either by the manufacturer or the regulatory agency The level of recall is determined by both the degree of risk and the extent of distribution of the product and in India is mainly directed at the distribution chain

On receiving the details of the defective substandard spurious batchbatches of a medicine to be recalled from the manufacturer or the stockist or the FDA the pharmacy should immediately check if the particular b a t c h i s i n s t o c k a n d i f s o s u s p e n d i t s s a l e immediately

Similarly if the regulatory authority in the country bans a particular medicine or FDC the pharmacy should immediately check and remove all the different brands of that particular medicine under consideration

The details of medicines and their batches to be recalled should be available in the q u a r a n t i n e a r e a w h e r e stocks are received and checked This is to ensure that such medicines do not come into the pharmacy

middot The pharmacy should develop SOPs for recall of medicines middot The pharmacy staff should be immediately informed about such medicines and

the details should be displayed in writing in a prominent place in the pharmacy middot Rapid action helps avoid unnecessary exposure to such medicines once the

problem has been d e t e c t e d middot The progress of the recall procedure in the pharmacy should be monitored every

few days to ensure complete compliance middot All stocks of the recalled products should be stored separately from the saleable

stock These can be stored in the expiry cupboard segregated from the expired goods and be appropriately labeled ldquoRecal l e d G o o d s - Not for Salerdquo

The supplier should be notified and asked to replace defective products middot All the details of the procedures followed should be duly recorded in a Recall

Register maintained specially for the purpose The register should include d etails such as -middot Date of the recall middot Nam e of the product

57

bullbull

middot Details of the product (name of manufacturer batch number expiry date) middot Nu m b er of units purchased sold a n d sto c k in ha nd middot Reason for recall middot Nam e of the supplier to whom produc ts w e r e returned along with the date and quantity middot Name and signature of the designated personnel carrying out the recall procedure and recording details middot Name and signature of the chief pharmacist verifying the recall procedures and recording details 4 4 Returned medicines

Medicines may be returned to the pharmacy by clients due to the following reasons -bull

bullbull Unused medicines bullbull Course not completed bullbull Therapy changed by doctor bullbull Side effects experienced by patient bull

bullbull DamagedDefective medicines bullbull Missing or defaced label bullbull Missing tablets in a stripblister bullbull Leakage in bottles bullbull Leakage in strips bull

bullbull Expired medicines

Appropriate SOPs should be framed and followed for their acceptancerefusal and disposal middot bull For unused medicines returned by clients the p harmacy personnel should verify

that these were purchased from their pharmacy They should then be checked for integrity of the packing the dosage form and the expiry date and verified with the client whether they were stored in appropriate conditions This again is at the discretion of each pharmacy

middot The damageddefective medicines returned to the pharmacy should be taken back and stored separately Existing stock of the same product should be checked for similar defects

middot Expired medicines should be accepted from clients at the discretion of the pharmacist and be immediately shifted to the expired goods cupboard These can be stored segregated from the pharmacys own expired goods and be appropriately labelled ldquoExpired Goods returned by clients- Not For Salerdquo

It is advisable not to accept returned medicines requiring cold chain storage (refrigeration) because it cannot be ensured that the cold chain was maintained when the medicines were in the hands of the patientclient middot Appropriate adjustments in t he stocks should be made for medicines

returnedexchanged to update the inventory middot The medicines should then be returned to the respective shelves middot A lsquoReturned Goodsrsquo register needs to be maintained to record all details of returned

medicines

R egister should include such details as-

58

middot N a m e o f t h e p a t i e n t middot Nam e of the product and quantity r e tu r n e d middot Product details such as the batch number and expiry date middot Condition in which received middot Reason for returning products middot Compensatory measures taken wi t h r e s p e c t t o c l i e n t middot Action taken with respect to product middot Name and signature of the personnel accepting the returned medicines and recording details middot Name and signature of the chief pharmacist verifying the recorded details

What the pharmacist would have learnt from this module The storage of medicines is a critical factor in the distribution cycle bullbull Stocks received by the pharmacy should be quarantined in a separate area and necessary checks s h o u ld be performed to ascertain the qua lity a nd quantity of stocks received bullbull Whatever pattern and means of storage used the products should be stored so as to maintain their potency and integrity bullbull Storage conditions should be monitored and maintained on a regular basis bullbull Optimum stock levels should be maintained and regularly monitored for expiry bullbull The design of storage areas should facilitate appropriate storage of medicines bullbull Cleanliness should be maintained in the pharmacy bullbull Adequate measures should be taken in case of returned medicines and recalled products

Optimum storage of medicines is mandatory whether at the distribution stage at the pharmacy or ultimately within the homes of patients The pharmacist has an important r o l e t o p l a y i n t h e s t o r a g e o f m e d i c i n e s i n m a i n t a i n i n g d r u g p o t ency and efficacy and thus facilitating optimum therapeutic benefits Good Pharmacy Practice - IPA -CDSCO - WHO Appendix I Quality Assurance Templates of letters for use if found not of Standard Quality [Frozen and expired goods ]

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated To Name of the Supplier with address

Sub Not of Standard Quality GoMP-Supply of Drugs and medicines-(Codename) Return of Stocks to the Suppliers-reg(New drug policy 2009) Previous letterinvoice ref Sl No Drug Code Drug name

Manufacturing date Expiry date

Supplier address

B a t c h n o

The above items of PO nodated was drawn by the Drug Inspector (Place) on (______________date) as a statutory sampling and declared ldquoNot of Standard

59

Qualityrdquo on -(______________date) by the Government Analyst for the following reasons

- ldquoThe product sample do not confirm to IP specification for (Drug codename with respect to the content of drugrdquo

- ldquoThe product has already been blacklisted by TNMSC on -(______________date) for the failure of (quantity) of batches of drug codenamerdquo

As per the clause of the te nde r d oc um e nt ldquo I f the sa mple s d o not c onf o r m to statutory standardsthe tenderer will be liable for relevant action under the existing laws and the entire stock in such batch should be taken back by the tenderer within a period of 30 days o f t h e r e c e i p t o f t h e l e t t e r f r o m t h e v e n u e

The stock shall be taken back at the expenses of the tendererthe Procurement Authority have the right to destroy such Not of Standard Quality if the tenderer does not take back the goods within the stipulated time

The Procuring Authority will arrange to destroy the Not of Standard Quality drugs within 90 days after the expiry of 30 days mentioned above without further notice and shall also collect demurrage charges calculated at the rate of 2 per week on the value of the drugs rejected till such destructionrdquo

Hence we regret to inform you that you will have to take back the stocks available of the abovesaid batch at your own cost from the drug stores where you have supplied the above batch

Kindly acknowledge the receipt of this reference at once

P r o c u r e m e n t A u t h o r i t y Seal and Stamp

Copy to Ref No dated

1 ) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated13082010

To

Sub Frozen Drugs-ordered to return to the Suppliers-reg(New drug policy 2009) Previous letterinvoice ref

The following products which were earlier frozen have now been ordered to return to suppliers directly with permission from the State drug Authority In this regard the suppliers have been instructed to take back their failed batch from the drug store of the stores Hence you are now instructed to return the following failed batches to the suppliers by obtaining proper authorization letter and acknowledgements from them

60

Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

Kindly acknowledge the receipt of this reference at once

Procurement Authority Seal and Stamp

Copy to

Ref No dated 2) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated14092010

To

Sub Frozen Drugs-ordered to return to the Suppliers- for issue of gate pass after verification reg(New drug policy 2009) Previous letterinvoice ref

The following products which were earlier frozen have now been released Hence they may be issued Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

Kindly acknowledge the receipt of this reference at once

Procurement Authority Seal and Stamp

Copy to

61

Ref No dated 3) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated

To

Sub Stop instruction-reg(New drug policy 2009) Previous letterinvoice ref

Until further instructions stop issue all the batches of the following item Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

You must intimate the available stock in the stores of the said batch Number to the Procurement Authority immediately Also retrieve quantity if already issued

Procurement Authority Seal and Stamp

Copy to

Ref No dated 4) HOD Procurement Office of

62

Appendix II Material handling in drug stores

Rack approx rates and dimensions

S No

Item Description UOM Approx Rate

1 MEDIUM DUTY RACK SIZE 2900 H X 3090 W X 800 D IN MM (AS PER SPECIFICATION)

Each 2499800

2 MEDIUM DUTY RACK ADD ON UNIT FOR SIZE OF SR NO2

Each 2243100

To locate a Box no 3 Rack no 14 in row3

SAMPLE OF RACK no Bin numbering -------------- S a y R K 1 4 R o w 3 B o x 1 6

SAMPLE LAYOUT of RACKS in a Drug Stores

63

Sample of another warehouse of distribution warehouse system

64

65

Slotted Angle racks with bin cards

66

Plastic Pallets

Plastic pallets ar e l i g h t w e i g h t l o w- c ost and exceed industry standards for strength and durability

NOTE A pallet has bottom deckboards (see sketch) A skid does not have bottom

67

deckboards

Battery Operated Stacker

Electric Stacker Ehh (Manual Push Type) - Manual drive - Lifting electrically with Battery 12 V 88 Ah - For loading and un-loading of trucks - Battery and loading device built - in - Battery charge gauge and charging current gauge Simple and Easy Operation - Lifting and Lowering electrically direct on steering arm - Pulling and pushing through steering arm - Electrically operated relief valve on hydraulic aggregate Safe Operation - Emergency Off Switch - Constant lowering speed - Protection through lowering brake valve - Overload protection through overload brake valve - Load chains covered preventing pinching threat - Electrically interlocking during loading process - Secured battery compartment opens upwardly - Stable buffering of the steering arm in upright position - In accordance with EWG Guidelines 89 240 - In accordance with VBG 12b Prevention of Accidents

Pallet Truck [ Top ]

68

----------------------------------------------------------------------------------------------------------------------------

For Transport Of All Goods On Pallets Safe and Easy Operation - through single hand operation Lifting moving

lowering with steering handle - neutral position of the hydraulic possible - overload pressure relief valve Long Service Life - robust co n s t r u c t i o n

- special hardened axles - hardened chromium plated ram - maintenance free Easy Maneuverability - through rubber steering rollers - nylon fork rollers

A h a n d t r o l l e y

69

Trolley with plastic bins for several items del ivery

70

Digital Weighing balances

Balances amp Scales EF Seriers Precision Electronic Balance

71

1

Ice lined Refrigerators

600 litres refrigrator

72

Walk in cooler

vacuum cleaner

73

Products needing freezing or refrigeration-middot Vaccines blood products and many other medicines lose potency if kept even for a

brief period at temperatures outside the recommended range For these products the cold chain must be maintained at every stage of the distribution system

middot Freezing is as damaging as high temperatures for some products including injectable contraceptives ergometrine insulin adrenaline and the DPT DT TT and Hepatitis B vaccines Such products therefore sho uld not be allowed to freeze (not be kept in the freezer compartment)

middot Short periods at room temperature (during transportation or local distribution for instance) may be acceptable for many products (such as ergometrine a n d i n s u l i n ) e v e n t h o u g h s u c h e x posure can to some extent reduce shelf life Other items such as vaccines should always be transported in cold boxes

Storage of insulin injections-

middot Insulin should always be stored in a refrigerator at the recommended temperature of 2 -8 C

middot Insulin should not be kept in the freezer compartment of the refrigerator middot Insulin should ideally be stored horizontally middot It should not be exposed to sunlight or excessive heat middot Insulin suspensions should not be used if the suspension cannot be properly

resuspended due to cake or clump formationbull

Controlled drugs -Narcotics (for example Pethidine injection morphine preparations) and other specified drugs that may be abused are governed by special legislation and regulations The following security measures are suggested in the pharmacy -middot A safe or reinforced double locked cabinet fitted with a light (preferably with a red

bulb) that comes on when the door is opened

49

middot A special register recording details of each receipt or issue with 2 signatures physi cal counting of medicines after each entry and signatures at handover takeover

middot Independent audit (by supervisors and drug inspectors)

Products prone to theft abuse or misuse -

Some medicinesproducts are particularly prone to theft abuse or misuse These include expensive medicines (eg insulin) certain antibiotics and products prone to abuse or misuse like psychotropics etc

Such medicinesproducts should be stored adequately They require stricter record keeping and more frequent stock taki ng than others Periodic audits should be carried out to check for consumption against actual recorded use (registers prescription records stock records etc) to expose any theft or misuse bull26 Storage and stability of medicines Medicines are not stab le indefinitely They are stable for a specific period of time sometimes for a brief period Poor storage conditions accelerate the drug degradation (decomposition) Temperature light and moisture are the most important contributing factors for drug instability It is important to identify and be aware of the potential for instability There is a need to comply with storage requirements to ensure quality medicines for patients It is also important to offer advice to patients too about appropriate storage o f medicines at home The dispensing label should state the storage condition required and be backed up by a verbal reminder especially where special storage is required bull

50

In case stability and storage problems are seen with formulations they should be reported immediately to the representative of the manufacturer and taken out of circulation till the stability problems have been resolved

The pharmacist can easily detect stability problems when products show change in appearance color odor settling of the product contents breaking of emulsions melting of creams oozing of contents from the containers and any such physical changes

3 STOCK CONTROL AND EXPIRY MONITORING 3 1 S t o c k C o n t r o l For economic reasons pharmacists do not like to have stock on their shelves for long periods of time The aim should always be to keep stock at a level that will just meet demand Normally most manufactured medicines have a long shelf life Even then it is essential that there is efficient stock rot ation so that the older stock is used first It is also a good practice to check the expiry date as an integral part of the dispensing process When short shelf life products are involved stock levels may have to be modified to prevent medicines regularl y expiring on the shelves

32 Stock rotation and expiry monitoring In order to avoid accumulation of expired and obsolete stock medicines should be stored and issued according to the following guidelines -middot The stock control system must record the ex p i r y d a t e a n d t h e d a t e o f r e c e i p t middot Stock must be stored so that earliest expiring batches are picked and issued first middot The First In First Out (FIFO) system - In this system the stock which is received

first is sold first This system however may not be useful for pharmacies because most of the stocks carry an expiry date For pharmacies the FEFO system is more practical

51

middot The First Expiry First Out (FEFO) system - In this system the stock having an earlier expiry is sold first The stock with longer shelf life should be placed farthest to the back (or at the bottom in case o f sta c k e d b oxe s) T h is is pa r tic u la r ly impor ta n t with products that have short shelf lives such as vaccines some vitamins antibiotics etc and reduces losses due to expiry

middot E x p i r y dates should be noted on the stock record upon receipt Stock nearing expiry should not be accepted unless it can be used before expiry

Computerization and expiry monitoring In the pharmacy computerization facilitates both checking stocks and expiry mo nitoring and helps-bullbullKeeping a check on products nearing expiry bullbullKeeping a check on non- moving and slow moving products bullbullTo facilitate the removal of medicines nearing expiry from shelves in time to send them back to the wholesaler or supplier

Periodic checking for expiry The expiry date for medicinal products is a critical aspect in pharmaceutical dispensing and due importance should be given to it Periodic checking for expiry of medicines will ensure that the patient will never receive products that have crossed their expiry date During periodical checking of expiry the personnel involved should remove medicines that are nearing expiry bullbullIn -house threshold periods should be set and followed for retrieval of such medicines from the shelves bullbullSuch medicines should be stored separately These should either be dispensed immediately (thus ensuring that they are used before the expiry date) o r t h e y s h o u l d b e returned to the suppliers bullbullA separate area should be designated (cupboard or shelf)marked[FROZEN ZONE] which is adequately marked EXPIRED GOODS- NOT FOR SALE to store all expired stocks FROZEN ZONE

52

Remember Expired medicines are a NATIONAL WASTE So stock only what you can sell Avoid expiries save precious medicines for the nation

Treatment and disposing of expired medicines bullbullProcedures need to be in place for the treatment of expired medicines bullbullThe expired medicines need to be collected and be sent back to the supplier or company for appropriate disposal bullbullRecords must be maintained for expired medicines and how they are disposed off bullbullIn case of medicines that are not returnable to suppliers procedures for disposal need to be followed by the pharmacy in conjunction with the FDA The following procedure can be followed if medicines cannot be returned to suppliers ( T h e b a s i c p h i l o s o p h y of appropriate disposal is to prevent their re- circulation and use) bullbullC u t t h e c o n t ainer in such a manner that the label is also cut In case of tablets and c a p s u l e s d e s t r o y them by disposing them in a bucket of water bullbullUse landfill procedures (deep burial into the ground as per stipulations of Medical Waste Disposal Act prevalent in the respective state) bullbullPour the liquids into the sink and wash away with sufficient quantity of water bullbullKeep a record of such disposal with full details of medicines destroyed Although these measures are usually adopted care has to be taken with such tr e a t m e n t a s studies have shown that flushing of medicines has resulted in tracessmall quantities of medicines being found in waterways and groundwater having potential health and environmental effects

4 O T H E R A S P E C T S 41 Design of storage areas The following important factors need to be considered in design of storage areas -middot The retail outlets in hot areas in summers should be air-conditioned Similarly in

a r e a s o f e x t r e m e c o l d t h e p r e m i s e s w o u l d r e q u i r e w a r m i n g e s p e c i a l l y i n w i n t e r s t o maintain cool temperatures The placement of air -conditioners and heating devices should be such that medicines are not directly exposed to the cold or heat

middot Due consideration should be given to storage requirements of formulations while designing shelves and cupboards in retail outlets Sufficient shelf height should be provided so that all liquid products can be stored vertically As far as possible the shelves should be covered with glass panels to protect medicines from dust and p r e v e n t r a p i d f l u c t u a t i o n s i n temperature

middot Medicines should be stored according to the storage instructions on the labels bullIt is ideal to have a door at the pharmacy entrance to prevent dust from coming in as well as reduceprevent cooled air from going out This may not however be considered feasiblepracticable by many pharmacy owners for fear that clients may not enter the pharmacy because the door may act as a barrier An air curtain is a good alternative to a door

middot There should be minimal direct sunlight falling on the products Particular consideration should be given to premises directly facing the sun

middot bullThe arrangement of lighting in the interior of the premises should also be in a manner that the lights are not focused on the products It has been shown that light causes not only chemical damage but also can catalyze physical changes like moisture uptak e by the products Care should be taken to ensure that only diffused light falls on them

53

middot As far as possible provision should be made for a temperature and humidity indicator device in a pharmacy These devices are now easily available

middot Stability studies o f m e d i c i n e s p a c k e d i n b l i s t e r s h a v e r e v e a l e d t h a t i f t h e s e a r e exposed to light they tend to absorb moisture It is therefore necessary to store them in suitable cartons so that the blisters are not exposed to light Pharmacists should do this even if the manufacturer has not provided cartons

middot Light and temperature sensitive products should not be stored on counters where the light is intense or direct and there is no protection from temperature and humidity

42 Cleaning and maintenance i) Cleaning of storage areas

The storage areas of the pharmacy should be cleaned periodically and cleanliness should be maintained at all times The Standard Operating Procedure for cleaning should be designed and followed accordingly Schedules for cleanups should be laid down and adequate cleaning equipment should be made available

Tips for maintaining cleanliness middot Provide clean pieces of cloth for wiping at various locations in the pharmacy

Replace with clean cloth at regular intervals middot Keep separate pieces of cloth for floors shelves and medicines middot Use a disinfectant andor soap solution to clean floors middot Ensure removal of dust and prevent accumulation of dirt middot Ensure removal of cobwebs middot Use a vacuum cleaner for cleaning areas not easily reachable middot T a k e c a r e t h at breakages are handled and cleared effectively middot Observe the factors leading to waste generation in the pharmacy and take appropriate

measures to tackle the problem middot Record all cleaning procedures performed and maintain all the documents required

For ex a m p l e -bullbullThe floor of the pharmacy may be swept with a broom and swabbed with soap water every morning bullbullThe floor may be swabbed with a disinfectant every week bullbullThe entire premises including shelves and cupboards may be cleaned with a cloth (to remove dust and to check for medicines approaching expiry date or expired medicines) every three months bullbullAll the steps followed should be r e c o r d e d

The floor shelves drawers have to be cleaned and a check should be kept on dust cobwebs spillages due to breakage etc It is therefore essential to have SOPs for cleaning laying down cleaning frequencies allotting responsibilities and maintaining a daily record in the logbook to document all these activities

54

While cleaning dust settled on dosage forms like bottles tubes etc should be removed Before dispensing the products should also be wiped to remove any dust settled during storage

For refrigerators bullbullDefrosting and cleaning should be done at regular intervals bullbullSwitch off the refrigerator while cleaning bullbullCleaning should be done quickly and stocks put back immediately

i i ) Pest control Pests are a serious problem in India where insects reptiles and rodents (eg cockroaches l i z a r d s r a t s s i l v e r f i s h (Deemak - in Hindi ) etc) may find access to the pharmacy storage areas Insects like ants and borer ants may often attack wood in the pharmacy causing d am ag e to shelves cupboardsPest c ontr o l in a p h a r m a c y c a n b e a d i f f i c u l t t a s k b u t t o avoid possible contamination and physical damage to stock it is necessary to keep pests out of the pharmacy premisesPest control measures should be implemented with proper p r e c a u t i o n s t a k i n g u t m o s t c a r e t o a v o i d contamination of medicines

55

Th e following pest control measures c a n be ta ke n f r om tim e to tim e -bullbullRat bait and traps can be placed at various locations bullbullInsecticutors can be used on a permanent basis bullbullInsecticidal sprays and repellants can be used from time to time

i i i ) Fire precautions

Combustible trash such as cartons boxes and other packing waste must not be allowed to accumulate in the store Waste should be deposited in appropriate waste bins and be d i s p o s e d o f f o n a d a i l y b a s i s

F i re detection and fire fighting equipment must be maintained and regularly inspected The pharmacy personnel should receive adequate training in fire fighting techniques and emergency actionFire prevention measures should include a prominently displayed ldquoNoSmokingrdquo sign careful handling and disposal of combustible waste materials and checking of electrical connections at regular intervals

iv) Security middot Doors shutters of the pharmacy should be strong and be fitted with secure locks middot Counters should be designed so that unauthorized personnelclients do not have

access to areas where prescription medicines are stored Access to such areas should be restricted to the pharmacy staff

middot All the pharmacy staff handling supplies should be accountable for their ac t i o n s

56

middot bullSpecial care must be taken in case of Schedule X and manufactured drugs (under NDPS Act) Such medicines should be kept under lock and key and the key should be kept with the Chief Pharmacist or i n h i s a b s e n c e t h e s e n i o r p h a r m a c i s t

v) Breakagespillage and damaged product Products that have been damagedspoiled during storage and handling spillages and broken glassware should be disposed off according to procedures laid down by the pharmacy Broken and damaged products s h o u l d b e p l a c e d i n a segregated area to be returned to the supplier

vi) Inspection Senior staff should inspect all pharmacy areas regularly The shelves and drawers should b e c h e c k e d d a i l y f o r signs of pests and dust Ceiling and walls should be checked for dirt and cobwebs Stock should be checked on a regular basis for deterioration due to climatic conditions

43 Product recalls Products found to be defective should be quickly recalled (withdrawn from the market) The instructions are generally issued either by the manufacturer or the regulatory agency The level of recall is determined by both the degree of risk and the extent of distribution of the product and in India is mainly directed at the distribution chain

On receiving the details of the defective substandard spurious batchbatches of a medicine to be recalled from the manufacturer or the stockist or the FDA the pharmacy should immediately check if the particular b a t c h i s i n s t o c k a n d i f s o s u s p e n d i t s s a l e immediately

Similarly if the regulatory authority in the country bans a particular medicine or FDC the pharmacy should immediately check and remove all the different brands of that particular medicine under consideration

The details of medicines and their batches to be recalled should be available in the q u a r a n t i n e a r e a w h e r e stocks are received and checked This is to ensure that such medicines do not come into the pharmacy

middot The pharmacy should develop SOPs for recall of medicines middot The pharmacy staff should be immediately informed about such medicines and

the details should be displayed in writing in a prominent place in the pharmacy middot Rapid action helps avoid unnecessary exposure to such medicines once the

problem has been d e t e c t e d middot The progress of the recall procedure in the pharmacy should be monitored every

few days to ensure complete compliance middot All stocks of the recalled products should be stored separately from the saleable

stock These can be stored in the expiry cupboard segregated from the expired goods and be appropriately labeled ldquoRecal l e d G o o d s - Not for Salerdquo

The supplier should be notified and asked to replace defective products middot All the details of the procedures followed should be duly recorded in a Recall

Register maintained specially for the purpose The register should include d etails such as -middot Date of the recall middot Nam e of the product

57

bullbull

middot Details of the product (name of manufacturer batch number expiry date) middot Nu m b er of units purchased sold a n d sto c k in ha nd middot Reason for recall middot Nam e of the supplier to whom produc ts w e r e returned along with the date and quantity middot Name and signature of the designated personnel carrying out the recall procedure and recording details middot Name and signature of the chief pharmacist verifying the recall procedures and recording details 4 4 Returned medicines

Medicines may be returned to the pharmacy by clients due to the following reasons -bull

bullbull Unused medicines bullbull Course not completed bullbull Therapy changed by doctor bullbull Side effects experienced by patient bull

bullbull DamagedDefective medicines bullbull Missing or defaced label bullbull Missing tablets in a stripblister bullbull Leakage in bottles bullbull Leakage in strips bull

bullbull Expired medicines

Appropriate SOPs should be framed and followed for their acceptancerefusal and disposal middot bull For unused medicines returned by clients the p harmacy personnel should verify

that these were purchased from their pharmacy They should then be checked for integrity of the packing the dosage form and the expiry date and verified with the client whether they were stored in appropriate conditions This again is at the discretion of each pharmacy

middot The damageddefective medicines returned to the pharmacy should be taken back and stored separately Existing stock of the same product should be checked for similar defects

middot Expired medicines should be accepted from clients at the discretion of the pharmacist and be immediately shifted to the expired goods cupboard These can be stored segregated from the pharmacys own expired goods and be appropriately labelled ldquoExpired Goods returned by clients- Not For Salerdquo

It is advisable not to accept returned medicines requiring cold chain storage (refrigeration) because it cannot be ensured that the cold chain was maintained when the medicines were in the hands of the patientclient middot Appropriate adjustments in t he stocks should be made for medicines

returnedexchanged to update the inventory middot The medicines should then be returned to the respective shelves middot A lsquoReturned Goodsrsquo register needs to be maintained to record all details of returned

medicines

R egister should include such details as-

58

middot N a m e o f t h e p a t i e n t middot Nam e of the product and quantity r e tu r n e d middot Product details such as the batch number and expiry date middot Condition in which received middot Reason for returning products middot Compensatory measures taken wi t h r e s p e c t t o c l i e n t middot Action taken with respect to product middot Name and signature of the personnel accepting the returned medicines and recording details middot Name and signature of the chief pharmacist verifying the recorded details

What the pharmacist would have learnt from this module The storage of medicines is a critical factor in the distribution cycle bullbull Stocks received by the pharmacy should be quarantined in a separate area and necessary checks s h o u ld be performed to ascertain the qua lity a nd quantity of stocks received bullbull Whatever pattern and means of storage used the products should be stored so as to maintain their potency and integrity bullbull Storage conditions should be monitored and maintained on a regular basis bullbull Optimum stock levels should be maintained and regularly monitored for expiry bullbull The design of storage areas should facilitate appropriate storage of medicines bullbull Cleanliness should be maintained in the pharmacy bullbull Adequate measures should be taken in case of returned medicines and recalled products

Optimum storage of medicines is mandatory whether at the distribution stage at the pharmacy or ultimately within the homes of patients The pharmacist has an important r o l e t o p l a y i n t h e s t o r a g e o f m e d i c i n e s i n m a i n t a i n i n g d r u g p o t ency and efficacy and thus facilitating optimum therapeutic benefits Good Pharmacy Practice - IPA -CDSCO - WHO Appendix I Quality Assurance Templates of letters for use if found not of Standard Quality [Frozen and expired goods ]

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated To Name of the Supplier with address

Sub Not of Standard Quality GoMP-Supply of Drugs and medicines-(Codename) Return of Stocks to the Suppliers-reg(New drug policy 2009) Previous letterinvoice ref Sl No Drug Code Drug name

Manufacturing date Expiry date

Supplier address

B a t c h n o

The above items of PO nodated was drawn by the Drug Inspector (Place) on (______________date) as a statutory sampling and declared ldquoNot of Standard

59

Qualityrdquo on -(______________date) by the Government Analyst for the following reasons

- ldquoThe product sample do not confirm to IP specification for (Drug codename with respect to the content of drugrdquo

- ldquoThe product has already been blacklisted by TNMSC on -(______________date) for the failure of (quantity) of batches of drug codenamerdquo

As per the clause of the te nde r d oc um e nt ldquo I f the sa mple s d o not c onf o r m to statutory standardsthe tenderer will be liable for relevant action under the existing laws and the entire stock in such batch should be taken back by the tenderer within a period of 30 days o f t h e r e c e i p t o f t h e l e t t e r f r o m t h e v e n u e

The stock shall be taken back at the expenses of the tendererthe Procurement Authority have the right to destroy such Not of Standard Quality if the tenderer does not take back the goods within the stipulated time

The Procuring Authority will arrange to destroy the Not of Standard Quality drugs within 90 days after the expiry of 30 days mentioned above without further notice and shall also collect demurrage charges calculated at the rate of 2 per week on the value of the drugs rejected till such destructionrdquo

Hence we regret to inform you that you will have to take back the stocks available of the abovesaid batch at your own cost from the drug stores where you have supplied the above batch

Kindly acknowledge the receipt of this reference at once

P r o c u r e m e n t A u t h o r i t y Seal and Stamp

Copy to Ref No dated

1 ) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated13082010

To

Sub Frozen Drugs-ordered to return to the Suppliers-reg(New drug policy 2009) Previous letterinvoice ref

The following products which were earlier frozen have now been ordered to return to suppliers directly with permission from the State drug Authority In this regard the suppliers have been instructed to take back their failed batch from the drug store of the stores Hence you are now instructed to return the following failed batches to the suppliers by obtaining proper authorization letter and acknowledgements from them

60

Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

Kindly acknowledge the receipt of this reference at once

Procurement Authority Seal and Stamp

Copy to

Ref No dated 2) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated14092010

To

Sub Frozen Drugs-ordered to return to the Suppliers- for issue of gate pass after verification reg(New drug policy 2009) Previous letterinvoice ref

The following products which were earlier frozen have now been released Hence they may be issued Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

Kindly acknowledge the receipt of this reference at once

Procurement Authority Seal and Stamp

Copy to

61

Ref No dated 3) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated

To

Sub Stop instruction-reg(New drug policy 2009) Previous letterinvoice ref

Until further instructions stop issue all the batches of the following item Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

You must intimate the available stock in the stores of the said batch Number to the Procurement Authority immediately Also retrieve quantity if already issued

Procurement Authority Seal and Stamp

Copy to

Ref No dated 4) HOD Procurement Office of

62

Appendix II Material handling in drug stores

Rack approx rates and dimensions

S No

Item Description UOM Approx Rate

1 MEDIUM DUTY RACK SIZE 2900 H X 3090 W X 800 D IN MM (AS PER SPECIFICATION)

Each 2499800

2 MEDIUM DUTY RACK ADD ON UNIT FOR SIZE OF SR NO2

Each 2243100

To locate a Box no 3 Rack no 14 in row3

SAMPLE OF RACK no Bin numbering -------------- S a y R K 1 4 R o w 3 B o x 1 6

SAMPLE LAYOUT of RACKS in a Drug Stores

63

Sample of another warehouse of distribution warehouse system

64

65

Slotted Angle racks with bin cards

66

Plastic Pallets

Plastic pallets ar e l i g h t w e i g h t l o w- c ost and exceed industry standards for strength and durability

NOTE A pallet has bottom deckboards (see sketch) A skid does not have bottom

67

deckboards

Battery Operated Stacker

Electric Stacker Ehh (Manual Push Type) - Manual drive - Lifting electrically with Battery 12 V 88 Ah - For loading and un-loading of trucks - Battery and loading device built - in - Battery charge gauge and charging current gauge Simple and Easy Operation - Lifting and Lowering electrically direct on steering arm - Pulling and pushing through steering arm - Electrically operated relief valve on hydraulic aggregate Safe Operation - Emergency Off Switch - Constant lowering speed - Protection through lowering brake valve - Overload protection through overload brake valve - Load chains covered preventing pinching threat - Electrically interlocking during loading process - Secured battery compartment opens upwardly - Stable buffering of the steering arm in upright position - In accordance with EWG Guidelines 89 240 - In accordance with VBG 12b Prevention of Accidents

Pallet Truck [ Top ]

68

----------------------------------------------------------------------------------------------------------------------------

For Transport Of All Goods On Pallets Safe and Easy Operation - through single hand operation Lifting moving

lowering with steering handle - neutral position of the hydraulic possible - overload pressure relief valve Long Service Life - robust co n s t r u c t i o n

- special hardened axles - hardened chromium plated ram - maintenance free Easy Maneuverability - through rubber steering rollers - nylon fork rollers

A h a n d t r o l l e y

69

Trolley with plastic bins for several items del ivery

70

Digital Weighing balances

Balances amp Scales EF Seriers Precision Electronic Balance

71

1

Ice lined Refrigerators

600 litres refrigrator

72

Walk in cooler

vacuum cleaner

73

middot A special register recording details of each receipt or issue with 2 signatures physi cal counting of medicines after each entry and signatures at handover takeover

middot Independent audit (by supervisors and drug inspectors)

Products prone to theft abuse or misuse -

Some medicinesproducts are particularly prone to theft abuse or misuse These include expensive medicines (eg insulin) certain antibiotics and products prone to abuse or misuse like psychotropics etc

Such medicinesproducts should be stored adequately They require stricter record keeping and more frequent stock taki ng than others Periodic audits should be carried out to check for consumption against actual recorded use (registers prescription records stock records etc) to expose any theft or misuse bull26 Storage and stability of medicines Medicines are not stab le indefinitely They are stable for a specific period of time sometimes for a brief period Poor storage conditions accelerate the drug degradation (decomposition) Temperature light and moisture are the most important contributing factors for drug instability It is important to identify and be aware of the potential for instability There is a need to comply with storage requirements to ensure quality medicines for patients It is also important to offer advice to patients too about appropriate storage o f medicines at home The dispensing label should state the storage condition required and be backed up by a verbal reminder especially where special storage is required bull

50

In case stability and storage problems are seen with formulations they should be reported immediately to the representative of the manufacturer and taken out of circulation till the stability problems have been resolved

The pharmacist can easily detect stability problems when products show change in appearance color odor settling of the product contents breaking of emulsions melting of creams oozing of contents from the containers and any such physical changes

3 STOCK CONTROL AND EXPIRY MONITORING 3 1 S t o c k C o n t r o l For economic reasons pharmacists do not like to have stock on their shelves for long periods of time The aim should always be to keep stock at a level that will just meet demand Normally most manufactured medicines have a long shelf life Even then it is essential that there is efficient stock rot ation so that the older stock is used first It is also a good practice to check the expiry date as an integral part of the dispensing process When short shelf life products are involved stock levels may have to be modified to prevent medicines regularl y expiring on the shelves

32 Stock rotation and expiry monitoring In order to avoid accumulation of expired and obsolete stock medicines should be stored and issued according to the following guidelines -middot The stock control system must record the ex p i r y d a t e a n d t h e d a t e o f r e c e i p t middot Stock must be stored so that earliest expiring batches are picked and issued first middot The First In First Out (FIFO) system - In this system the stock which is received

first is sold first This system however may not be useful for pharmacies because most of the stocks carry an expiry date For pharmacies the FEFO system is more practical

51

middot The First Expiry First Out (FEFO) system - In this system the stock having an earlier expiry is sold first The stock with longer shelf life should be placed farthest to the back (or at the bottom in case o f sta c k e d b oxe s) T h is is pa r tic u la r ly impor ta n t with products that have short shelf lives such as vaccines some vitamins antibiotics etc and reduces losses due to expiry

middot E x p i r y dates should be noted on the stock record upon receipt Stock nearing expiry should not be accepted unless it can be used before expiry

Computerization and expiry monitoring In the pharmacy computerization facilitates both checking stocks and expiry mo nitoring and helps-bullbullKeeping a check on products nearing expiry bullbullKeeping a check on non- moving and slow moving products bullbullTo facilitate the removal of medicines nearing expiry from shelves in time to send them back to the wholesaler or supplier

Periodic checking for expiry The expiry date for medicinal products is a critical aspect in pharmaceutical dispensing and due importance should be given to it Periodic checking for expiry of medicines will ensure that the patient will never receive products that have crossed their expiry date During periodical checking of expiry the personnel involved should remove medicines that are nearing expiry bullbullIn -house threshold periods should be set and followed for retrieval of such medicines from the shelves bullbullSuch medicines should be stored separately These should either be dispensed immediately (thus ensuring that they are used before the expiry date) o r t h e y s h o u l d b e returned to the suppliers bullbullA separate area should be designated (cupboard or shelf)marked[FROZEN ZONE] which is adequately marked EXPIRED GOODS- NOT FOR SALE to store all expired stocks FROZEN ZONE

52

Remember Expired medicines are a NATIONAL WASTE So stock only what you can sell Avoid expiries save precious medicines for the nation

Treatment and disposing of expired medicines bullbullProcedures need to be in place for the treatment of expired medicines bullbullThe expired medicines need to be collected and be sent back to the supplier or company for appropriate disposal bullbullRecords must be maintained for expired medicines and how they are disposed off bullbullIn case of medicines that are not returnable to suppliers procedures for disposal need to be followed by the pharmacy in conjunction with the FDA The following procedure can be followed if medicines cannot be returned to suppliers ( T h e b a s i c p h i l o s o p h y of appropriate disposal is to prevent their re- circulation and use) bullbullC u t t h e c o n t ainer in such a manner that the label is also cut In case of tablets and c a p s u l e s d e s t r o y them by disposing them in a bucket of water bullbullUse landfill procedures (deep burial into the ground as per stipulations of Medical Waste Disposal Act prevalent in the respective state) bullbullPour the liquids into the sink and wash away with sufficient quantity of water bullbullKeep a record of such disposal with full details of medicines destroyed Although these measures are usually adopted care has to be taken with such tr e a t m e n t a s studies have shown that flushing of medicines has resulted in tracessmall quantities of medicines being found in waterways and groundwater having potential health and environmental effects

4 O T H E R A S P E C T S 41 Design of storage areas The following important factors need to be considered in design of storage areas -middot The retail outlets in hot areas in summers should be air-conditioned Similarly in

a r e a s o f e x t r e m e c o l d t h e p r e m i s e s w o u l d r e q u i r e w a r m i n g e s p e c i a l l y i n w i n t e r s t o maintain cool temperatures The placement of air -conditioners and heating devices should be such that medicines are not directly exposed to the cold or heat

middot Due consideration should be given to storage requirements of formulations while designing shelves and cupboards in retail outlets Sufficient shelf height should be provided so that all liquid products can be stored vertically As far as possible the shelves should be covered with glass panels to protect medicines from dust and p r e v e n t r a p i d f l u c t u a t i o n s i n temperature

middot Medicines should be stored according to the storage instructions on the labels bullIt is ideal to have a door at the pharmacy entrance to prevent dust from coming in as well as reduceprevent cooled air from going out This may not however be considered feasiblepracticable by many pharmacy owners for fear that clients may not enter the pharmacy because the door may act as a barrier An air curtain is a good alternative to a door

middot There should be minimal direct sunlight falling on the products Particular consideration should be given to premises directly facing the sun

middot bullThe arrangement of lighting in the interior of the premises should also be in a manner that the lights are not focused on the products It has been shown that light causes not only chemical damage but also can catalyze physical changes like moisture uptak e by the products Care should be taken to ensure that only diffused light falls on them

53

middot As far as possible provision should be made for a temperature and humidity indicator device in a pharmacy These devices are now easily available

middot Stability studies o f m e d i c i n e s p a c k e d i n b l i s t e r s h a v e r e v e a l e d t h a t i f t h e s e a r e exposed to light they tend to absorb moisture It is therefore necessary to store them in suitable cartons so that the blisters are not exposed to light Pharmacists should do this even if the manufacturer has not provided cartons

middot Light and temperature sensitive products should not be stored on counters where the light is intense or direct and there is no protection from temperature and humidity

42 Cleaning and maintenance i) Cleaning of storage areas

The storage areas of the pharmacy should be cleaned periodically and cleanliness should be maintained at all times The Standard Operating Procedure for cleaning should be designed and followed accordingly Schedules for cleanups should be laid down and adequate cleaning equipment should be made available

Tips for maintaining cleanliness middot Provide clean pieces of cloth for wiping at various locations in the pharmacy

Replace with clean cloth at regular intervals middot Keep separate pieces of cloth for floors shelves and medicines middot Use a disinfectant andor soap solution to clean floors middot Ensure removal of dust and prevent accumulation of dirt middot Ensure removal of cobwebs middot Use a vacuum cleaner for cleaning areas not easily reachable middot T a k e c a r e t h at breakages are handled and cleared effectively middot Observe the factors leading to waste generation in the pharmacy and take appropriate

measures to tackle the problem middot Record all cleaning procedures performed and maintain all the documents required

For ex a m p l e -bullbullThe floor of the pharmacy may be swept with a broom and swabbed with soap water every morning bullbullThe floor may be swabbed with a disinfectant every week bullbullThe entire premises including shelves and cupboards may be cleaned with a cloth (to remove dust and to check for medicines approaching expiry date or expired medicines) every three months bullbullAll the steps followed should be r e c o r d e d

The floor shelves drawers have to be cleaned and a check should be kept on dust cobwebs spillages due to breakage etc It is therefore essential to have SOPs for cleaning laying down cleaning frequencies allotting responsibilities and maintaining a daily record in the logbook to document all these activities

54

While cleaning dust settled on dosage forms like bottles tubes etc should be removed Before dispensing the products should also be wiped to remove any dust settled during storage

For refrigerators bullbullDefrosting and cleaning should be done at regular intervals bullbullSwitch off the refrigerator while cleaning bullbullCleaning should be done quickly and stocks put back immediately

i i ) Pest control Pests are a serious problem in India where insects reptiles and rodents (eg cockroaches l i z a r d s r a t s s i l v e r f i s h (Deemak - in Hindi ) etc) may find access to the pharmacy storage areas Insects like ants and borer ants may often attack wood in the pharmacy causing d am ag e to shelves cupboardsPest c ontr o l in a p h a r m a c y c a n b e a d i f f i c u l t t a s k b u t t o avoid possible contamination and physical damage to stock it is necessary to keep pests out of the pharmacy premisesPest control measures should be implemented with proper p r e c a u t i o n s t a k i n g u t m o s t c a r e t o a v o i d contamination of medicines

55

Th e following pest control measures c a n be ta ke n f r om tim e to tim e -bullbullRat bait and traps can be placed at various locations bullbullInsecticutors can be used on a permanent basis bullbullInsecticidal sprays and repellants can be used from time to time

i i i ) Fire precautions

Combustible trash such as cartons boxes and other packing waste must not be allowed to accumulate in the store Waste should be deposited in appropriate waste bins and be d i s p o s e d o f f o n a d a i l y b a s i s

F i re detection and fire fighting equipment must be maintained and regularly inspected The pharmacy personnel should receive adequate training in fire fighting techniques and emergency actionFire prevention measures should include a prominently displayed ldquoNoSmokingrdquo sign careful handling and disposal of combustible waste materials and checking of electrical connections at regular intervals

iv) Security middot Doors shutters of the pharmacy should be strong and be fitted with secure locks middot Counters should be designed so that unauthorized personnelclients do not have

access to areas where prescription medicines are stored Access to such areas should be restricted to the pharmacy staff

middot All the pharmacy staff handling supplies should be accountable for their ac t i o n s

56

middot bullSpecial care must be taken in case of Schedule X and manufactured drugs (under NDPS Act) Such medicines should be kept under lock and key and the key should be kept with the Chief Pharmacist or i n h i s a b s e n c e t h e s e n i o r p h a r m a c i s t

v) Breakagespillage and damaged product Products that have been damagedspoiled during storage and handling spillages and broken glassware should be disposed off according to procedures laid down by the pharmacy Broken and damaged products s h o u l d b e p l a c e d i n a segregated area to be returned to the supplier

vi) Inspection Senior staff should inspect all pharmacy areas regularly The shelves and drawers should b e c h e c k e d d a i l y f o r signs of pests and dust Ceiling and walls should be checked for dirt and cobwebs Stock should be checked on a regular basis for deterioration due to climatic conditions

43 Product recalls Products found to be defective should be quickly recalled (withdrawn from the market) The instructions are generally issued either by the manufacturer or the regulatory agency The level of recall is determined by both the degree of risk and the extent of distribution of the product and in India is mainly directed at the distribution chain

On receiving the details of the defective substandard spurious batchbatches of a medicine to be recalled from the manufacturer or the stockist or the FDA the pharmacy should immediately check if the particular b a t c h i s i n s t o c k a n d i f s o s u s p e n d i t s s a l e immediately

Similarly if the regulatory authority in the country bans a particular medicine or FDC the pharmacy should immediately check and remove all the different brands of that particular medicine under consideration

The details of medicines and their batches to be recalled should be available in the q u a r a n t i n e a r e a w h e r e stocks are received and checked This is to ensure that such medicines do not come into the pharmacy

middot The pharmacy should develop SOPs for recall of medicines middot The pharmacy staff should be immediately informed about such medicines and

the details should be displayed in writing in a prominent place in the pharmacy middot Rapid action helps avoid unnecessary exposure to such medicines once the

problem has been d e t e c t e d middot The progress of the recall procedure in the pharmacy should be monitored every

few days to ensure complete compliance middot All stocks of the recalled products should be stored separately from the saleable

stock These can be stored in the expiry cupboard segregated from the expired goods and be appropriately labeled ldquoRecal l e d G o o d s - Not for Salerdquo

The supplier should be notified and asked to replace defective products middot All the details of the procedures followed should be duly recorded in a Recall

Register maintained specially for the purpose The register should include d etails such as -middot Date of the recall middot Nam e of the product

57

bullbull

middot Details of the product (name of manufacturer batch number expiry date) middot Nu m b er of units purchased sold a n d sto c k in ha nd middot Reason for recall middot Nam e of the supplier to whom produc ts w e r e returned along with the date and quantity middot Name and signature of the designated personnel carrying out the recall procedure and recording details middot Name and signature of the chief pharmacist verifying the recall procedures and recording details 4 4 Returned medicines

Medicines may be returned to the pharmacy by clients due to the following reasons -bull

bullbull Unused medicines bullbull Course not completed bullbull Therapy changed by doctor bullbull Side effects experienced by patient bull

bullbull DamagedDefective medicines bullbull Missing or defaced label bullbull Missing tablets in a stripblister bullbull Leakage in bottles bullbull Leakage in strips bull

bullbull Expired medicines

Appropriate SOPs should be framed and followed for their acceptancerefusal and disposal middot bull For unused medicines returned by clients the p harmacy personnel should verify

that these were purchased from their pharmacy They should then be checked for integrity of the packing the dosage form and the expiry date and verified with the client whether they were stored in appropriate conditions This again is at the discretion of each pharmacy

middot The damageddefective medicines returned to the pharmacy should be taken back and stored separately Existing stock of the same product should be checked for similar defects

middot Expired medicines should be accepted from clients at the discretion of the pharmacist and be immediately shifted to the expired goods cupboard These can be stored segregated from the pharmacys own expired goods and be appropriately labelled ldquoExpired Goods returned by clients- Not For Salerdquo

It is advisable not to accept returned medicines requiring cold chain storage (refrigeration) because it cannot be ensured that the cold chain was maintained when the medicines were in the hands of the patientclient middot Appropriate adjustments in t he stocks should be made for medicines

returnedexchanged to update the inventory middot The medicines should then be returned to the respective shelves middot A lsquoReturned Goodsrsquo register needs to be maintained to record all details of returned

medicines

R egister should include such details as-

58

middot N a m e o f t h e p a t i e n t middot Nam e of the product and quantity r e tu r n e d middot Product details such as the batch number and expiry date middot Condition in which received middot Reason for returning products middot Compensatory measures taken wi t h r e s p e c t t o c l i e n t middot Action taken with respect to product middot Name and signature of the personnel accepting the returned medicines and recording details middot Name and signature of the chief pharmacist verifying the recorded details

What the pharmacist would have learnt from this module The storage of medicines is a critical factor in the distribution cycle bullbull Stocks received by the pharmacy should be quarantined in a separate area and necessary checks s h o u ld be performed to ascertain the qua lity a nd quantity of stocks received bullbull Whatever pattern and means of storage used the products should be stored so as to maintain their potency and integrity bullbull Storage conditions should be monitored and maintained on a regular basis bullbull Optimum stock levels should be maintained and regularly monitored for expiry bullbull The design of storage areas should facilitate appropriate storage of medicines bullbull Cleanliness should be maintained in the pharmacy bullbull Adequate measures should be taken in case of returned medicines and recalled products

Optimum storage of medicines is mandatory whether at the distribution stage at the pharmacy or ultimately within the homes of patients The pharmacist has an important r o l e t o p l a y i n t h e s t o r a g e o f m e d i c i n e s i n m a i n t a i n i n g d r u g p o t ency and efficacy and thus facilitating optimum therapeutic benefits Good Pharmacy Practice - IPA -CDSCO - WHO Appendix I Quality Assurance Templates of letters for use if found not of Standard Quality [Frozen and expired goods ]

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated To Name of the Supplier with address

Sub Not of Standard Quality GoMP-Supply of Drugs and medicines-(Codename) Return of Stocks to the Suppliers-reg(New drug policy 2009) Previous letterinvoice ref Sl No Drug Code Drug name

Manufacturing date Expiry date

Supplier address

B a t c h n o

The above items of PO nodated was drawn by the Drug Inspector (Place) on (______________date) as a statutory sampling and declared ldquoNot of Standard

59

Qualityrdquo on -(______________date) by the Government Analyst for the following reasons

- ldquoThe product sample do not confirm to IP specification for (Drug codename with respect to the content of drugrdquo

- ldquoThe product has already been blacklisted by TNMSC on -(______________date) for the failure of (quantity) of batches of drug codenamerdquo

As per the clause of the te nde r d oc um e nt ldquo I f the sa mple s d o not c onf o r m to statutory standardsthe tenderer will be liable for relevant action under the existing laws and the entire stock in such batch should be taken back by the tenderer within a period of 30 days o f t h e r e c e i p t o f t h e l e t t e r f r o m t h e v e n u e

The stock shall be taken back at the expenses of the tendererthe Procurement Authority have the right to destroy such Not of Standard Quality if the tenderer does not take back the goods within the stipulated time

The Procuring Authority will arrange to destroy the Not of Standard Quality drugs within 90 days after the expiry of 30 days mentioned above without further notice and shall also collect demurrage charges calculated at the rate of 2 per week on the value of the drugs rejected till such destructionrdquo

Hence we regret to inform you that you will have to take back the stocks available of the abovesaid batch at your own cost from the drug stores where you have supplied the above batch

Kindly acknowledge the receipt of this reference at once

P r o c u r e m e n t A u t h o r i t y Seal and Stamp

Copy to Ref No dated

1 ) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated13082010

To

Sub Frozen Drugs-ordered to return to the Suppliers-reg(New drug policy 2009) Previous letterinvoice ref

The following products which were earlier frozen have now been ordered to return to suppliers directly with permission from the State drug Authority In this regard the suppliers have been instructed to take back their failed batch from the drug store of the stores Hence you are now instructed to return the following failed batches to the suppliers by obtaining proper authorization letter and acknowledgements from them

60

Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

Kindly acknowledge the receipt of this reference at once

Procurement Authority Seal and Stamp

Copy to

Ref No dated 2) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated14092010

To

Sub Frozen Drugs-ordered to return to the Suppliers- for issue of gate pass after verification reg(New drug policy 2009) Previous letterinvoice ref

The following products which were earlier frozen have now been released Hence they may be issued Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

Kindly acknowledge the receipt of this reference at once

Procurement Authority Seal and Stamp

Copy to

61

Ref No dated 3) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated

To

Sub Stop instruction-reg(New drug policy 2009) Previous letterinvoice ref

Until further instructions stop issue all the batches of the following item Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

You must intimate the available stock in the stores of the said batch Number to the Procurement Authority immediately Also retrieve quantity if already issued

Procurement Authority Seal and Stamp

Copy to

Ref No dated 4) HOD Procurement Office of

62

Appendix II Material handling in drug stores

Rack approx rates and dimensions

S No

Item Description UOM Approx Rate

1 MEDIUM DUTY RACK SIZE 2900 H X 3090 W X 800 D IN MM (AS PER SPECIFICATION)

Each 2499800

2 MEDIUM DUTY RACK ADD ON UNIT FOR SIZE OF SR NO2

Each 2243100

To locate a Box no 3 Rack no 14 in row3

SAMPLE OF RACK no Bin numbering -------------- S a y R K 1 4 R o w 3 B o x 1 6

SAMPLE LAYOUT of RACKS in a Drug Stores

63

Sample of another warehouse of distribution warehouse system

64

65

Slotted Angle racks with bin cards

66

Plastic Pallets

Plastic pallets ar e l i g h t w e i g h t l o w- c ost and exceed industry standards for strength and durability

NOTE A pallet has bottom deckboards (see sketch) A skid does not have bottom

67

deckboards

Battery Operated Stacker

Electric Stacker Ehh (Manual Push Type) - Manual drive - Lifting electrically with Battery 12 V 88 Ah - For loading and un-loading of trucks - Battery and loading device built - in - Battery charge gauge and charging current gauge Simple and Easy Operation - Lifting and Lowering electrically direct on steering arm - Pulling and pushing through steering arm - Electrically operated relief valve on hydraulic aggregate Safe Operation - Emergency Off Switch - Constant lowering speed - Protection through lowering brake valve - Overload protection through overload brake valve - Load chains covered preventing pinching threat - Electrically interlocking during loading process - Secured battery compartment opens upwardly - Stable buffering of the steering arm in upright position - In accordance with EWG Guidelines 89 240 - In accordance with VBG 12b Prevention of Accidents

Pallet Truck [ Top ]

68

----------------------------------------------------------------------------------------------------------------------------

For Transport Of All Goods On Pallets Safe and Easy Operation - through single hand operation Lifting moving

lowering with steering handle - neutral position of the hydraulic possible - overload pressure relief valve Long Service Life - robust co n s t r u c t i o n

- special hardened axles - hardened chromium plated ram - maintenance free Easy Maneuverability - through rubber steering rollers - nylon fork rollers

A h a n d t r o l l e y

69

Trolley with plastic bins for several items del ivery

70

Digital Weighing balances

Balances amp Scales EF Seriers Precision Electronic Balance

71

1

Ice lined Refrigerators

600 litres refrigrator

72

Walk in cooler

vacuum cleaner

73

In case stability and storage problems are seen with formulations they should be reported immediately to the representative of the manufacturer and taken out of circulation till the stability problems have been resolved

The pharmacist can easily detect stability problems when products show change in appearance color odor settling of the product contents breaking of emulsions melting of creams oozing of contents from the containers and any such physical changes

3 STOCK CONTROL AND EXPIRY MONITORING 3 1 S t o c k C o n t r o l For economic reasons pharmacists do not like to have stock on their shelves for long periods of time The aim should always be to keep stock at a level that will just meet demand Normally most manufactured medicines have a long shelf life Even then it is essential that there is efficient stock rot ation so that the older stock is used first It is also a good practice to check the expiry date as an integral part of the dispensing process When short shelf life products are involved stock levels may have to be modified to prevent medicines regularl y expiring on the shelves

32 Stock rotation and expiry monitoring In order to avoid accumulation of expired and obsolete stock medicines should be stored and issued according to the following guidelines -middot The stock control system must record the ex p i r y d a t e a n d t h e d a t e o f r e c e i p t middot Stock must be stored so that earliest expiring batches are picked and issued first middot The First In First Out (FIFO) system - In this system the stock which is received

first is sold first This system however may not be useful for pharmacies because most of the stocks carry an expiry date For pharmacies the FEFO system is more practical

51

middot The First Expiry First Out (FEFO) system - In this system the stock having an earlier expiry is sold first The stock with longer shelf life should be placed farthest to the back (or at the bottom in case o f sta c k e d b oxe s) T h is is pa r tic u la r ly impor ta n t with products that have short shelf lives such as vaccines some vitamins antibiotics etc and reduces losses due to expiry

middot E x p i r y dates should be noted on the stock record upon receipt Stock nearing expiry should not be accepted unless it can be used before expiry

Computerization and expiry monitoring In the pharmacy computerization facilitates both checking stocks and expiry mo nitoring and helps-bullbullKeeping a check on products nearing expiry bullbullKeeping a check on non- moving and slow moving products bullbullTo facilitate the removal of medicines nearing expiry from shelves in time to send them back to the wholesaler or supplier

Periodic checking for expiry The expiry date for medicinal products is a critical aspect in pharmaceutical dispensing and due importance should be given to it Periodic checking for expiry of medicines will ensure that the patient will never receive products that have crossed their expiry date During periodical checking of expiry the personnel involved should remove medicines that are nearing expiry bullbullIn -house threshold periods should be set and followed for retrieval of such medicines from the shelves bullbullSuch medicines should be stored separately These should either be dispensed immediately (thus ensuring that they are used before the expiry date) o r t h e y s h o u l d b e returned to the suppliers bullbullA separate area should be designated (cupboard or shelf)marked[FROZEN ZONE] which is adequately marked EXPIRED GOODS- NOT FOR SALE to store all expired stocks FROZEN ZONE

52

Remember Expired medicines are a NATIONAL WASTE So stock only what you can sell Avoid expiries save precious medicines for the nation

Treatment and disposing of expired medicines bullbullProcedures need to be in place for the treatment of expired medicines bullbullThe expired medicines need to be collected and be sent back to the supplier or company for appropriate disposal bullbullRecords must be maintained for expired medicines and how they are disposed off bullbullIn case of medicines that are not returnable to suppliers procedures for disposal need to be followed by the pharmacy in conjunction with the FDA The following procedure can be followed if medicines cannot be returned to suppliers ( T h e b a s i c p h i l o s o p h y of appropriate disposal is to prevent their re- circulation and use) bullbullC u t t h e c o n t ainer in such a manner that the label is also cut In case of tablets and c a p s u l e s d e s t r o y them by disposing them in a bucket of water bullbullUse landfill procedures (deep burial into the ground as per stipulations of Medical Waste Disposal Act prevalent in the respective state) bullbullPour the liquids into the sink and wash away with sufficient quantity of water bullbullKeep a record of such disposal with full details of medicines destroyed Although these measures are usually adopted care has to be taken with such tr e a t m e n t a s studies have shown that flushing of medicines has resulted in tracessmall quantities of medicines being found in waterways and groundwater having potential health and environmental effects

4 O T H E R A S P E C T S 41 Design of storage areas The following important factors need to be considered in design of storage areas -middot The retail outlets in hot areas in summers should be air-conditioned Similarly in

a r e a s o f e x t r e m e c o l d t h e p r e m i s e s w o u l d r e q u i r e w a r m i n g e s p e c i a l l y i n w i n t e r s t o maintain cool temperatures The placement of air -conditioners and heating devices should be such that medicines are not directly exposed to the cold or heat

middot Due consideration should be given to storage requirements of formulations while designing shelves and cupboards in retail outlets Sufficient shelf height should be provided so that all liquid products can be stored vertically As far as possible the shelves should be covered with glass panels to protect medicines from dust and p r e v e n t r a p i d f l u c t u a t i o n s i n temperature

middot Medicines should be stored according to the storage instructions on the labels bullIt is ideal to have a door at the pharmacy entrance to prevent dust from coming in as well as reduceprevent cooled air from going out This may not however be considered feasiblepracticable by many pharmacy owners for fear that clients may not enter the pharmacy because the door may act as a barrier An air curtain is a good alternative to a door

middot There should be minimal direct sunlight falling on the products Particular consideration should be given to premises directly facing the sun

middot bullThe arrangement of lighting in the interior of the premises should also be in a manner that the lights are not focused on the products It has been shown that light causes not only chemical damage but also can catalyze physical changes like moisture uptak e by the products Care should be taken to ensure that only diffused light falls on them

53

middot As far as possible provision should be made for a temperature and humidity indicator device in a pharmacy These devices are now easily available

middot Stability studies o f m e d i c i n e s p a c k e d i n b l i s t e r s h a v e r e v e a l e d t h a t i f t h e s e a r e exposed to light they tend to absorb moisture It is therefore necessary to store them in suitable cartons so that the blisters are not exposed to light Pharmacists should do this even if the manufacturer has not provided cartons

middot Light and temperature sensitive products should not be stored on counters where the light is intense or direct and there is no protection from temperature and humidity

42 Cleaning and maintenance i) Cleaning of storage areas

The storage areas of the pharmacy should be cleaned periodically and cleanliness should be maintained at all times The Standard Operating Procedure for cleaning should be designed and followed accordingly Schedules for cleanups should be laid down and adequate cleaning equipment should be made available

Tips for maintaining cleanliness middot Provide clean pieces of cloth for wiping at various locations in the pharmacy

Replace with clean cloth at regular intervals middot Keep separate pieces of cloth for floors shelves and medicines middot Use a disinfectant andor soap solution to clean floors middot Ensure removal of dust and prevent accumulation of dirt middot Ensure removal of cobwebs middot Use a vacuum cleaner for cleaning areas not easily reachable middot T a k e c a r e t h at breakages are handled and cleared effectively middot Observe the factors leading to waste generation in the pharmacy and take appropriate

measures to tackle the problem middot Record all cleaning procedures performed and maintain all the documents required

For ex a m p l e -bullbullThe floor of the pharmacy may be swept with a broom and swabbed with soap water every morning bullbullThe floor may be swabbed with a disinfectant every week bullbullThe entire premises including shelves and cupboards may be cleaned with a cloth (to remove dust and to check for medicines approaching expiry date or expired medicines) every three months bullbullAll the steps followed should be r e c o r d e d

The floor shelves drawers have to be cleaned and a check should be kept on dust cobwebs spillages due to breakage etc It is therefore essential to have SOPs for cleaning laying down cleaning frequencies allotting responsibilities and maintaining a daily record in the logbook to document all these activities

54

While cleaning dust settled on dosage forms like bottles tubes etc should be removed Before dispensing the products should also be wiped to remove any dust settled during storage

For refrigerators bullbullDefrosting and cleaning should be done at regular intervals bullbullSwitch off the refrigerator while cleaning bullbullCleaning should be done quickly and stocks put back immediately

i i ) Pest control Pests are a serious problem in India where insects reptiles and rodents (eg cockroaches l i z a r d s r a t s s i l v e r f i s h (Deemak - in Hindi ) etc) may find access to the pharmacy storage areas Insects like ants and borer ants may often attack wood in the pharmacy causing d am ag e to shelves cupboardsPest c ontr o l in a p h a r m a c y c a n b e a d i f f i c u l t t a s k b u t t o avoid possible contamination and physical damage to stock it is necessary to keep pests out of the pharmacy premisesPest control measures should be implemented with proper p r e c a u t i o n s t a k i n g u t m o s t c a r e t o a v o i d contamination of medicines

55

Th e following pest control measures c a n be ta ke n f r om tim e to tim e -bullbullRat bait and traps can be placed at various locations bullbullInsecticutors can be used on a permanent basis bullbullInsecticidal sprays and repellants can be used from time to time

i i i ) Fire precautions

Combustible trash such as cartons boxes and other packing waste must not be allowed to accumulate in the store Waste should be deposited in appropriate waste bins and be d i s p o s e d o f f o n a d a i l y b a s i s

F i re detection and fire fighting equipment must be maintained and regularly inspected The pharmacy personnel should receive adequate training in fire fighting techniques and emergency actionFire prevention measures should include a prominently displayed ldquoNoSmokingrdquo sign careful handling and disposal of combustible waste materials and checking of electrical connections at regular intervals

iv) Security middot Doors shutters of the pharmacy should be strong and be fitted with secure locks middot Counters should be designed so that unauthorized personnelclients do not have

access to areas where prescription medicines are stored Access to such areas should be restricted to the pharmacy staff

middot All the pharmacy staff handling supplies should be accountable for their ac t i o n s

56

middot bullSpecial care must be taken in case of Schedule X and manufactured drugs (under NDPS Act) Such medicines should be kept under lock and key and the key should be kept with the Chief Pharmacist or i n h i s a b s e n c e t h e s e n i o r p h a r m a c i s t

v) Breakagespillage and damaged product Products that have been damagedspoiled during storage and handling spillages and broken glassware should be disposed off according to procedures laid down by the pharmacy Broken and damaged products s h o u l d b e p l a c e d i n a segregated area to be returned to the supplier

vi) Inspection Senior staff should inspect all pharmacy areas regularly The shelves and drawers should b e c h e c k e d d a i l y f o r signs of pests and dust Ceiling and walls should be checked for dirt and cobwebs Stock should be checked on a regular basis for deterioration due to climatic conditions

43 Product recalls Products found to be defective should be quickly recalled (withdrawn from the market) The instructions are generally issued either by the manufacturer or the regulatory agency The level of recall is determined by both the degree of risk and the extent of distribution of the product and in India is mainly directed at the distribution chain

On receiving the details of the defective substandard spurious batchbatches of a medicine to be recalled from the manufacturer or the stockist or the FDA the pharmacy should immediately check if the particular b a t c h i s i n s t o c k a n d i f s o s u s p e n d i t s s a l e immediately

Similarly if the regulatory authority in the country bans a particular medicine or FDC the pharmacy should immediately check and remove all the different brands of that particular medicine under consideration

The details of medicines and their batches to be recalled should be available in the q u a r a n t i n e a r e a w h e r e stocks are received and checked This is to ensure that such medicines do not come into the pharmacy

middot The pharmacy should develop SOPs for recall of medicines middot The pharmacy staff should be immediately informed about such medicines and

the details should be displayed in writing in a prominent place in the pharmacy middot Rapid action helps avoid unnecessary exposure to such medicines once the

problem has been d e t e c t e d middot The progress of the recall procedure in the pharmacy should be monitored every

few days to ensure complete compliance middot All stocks of the recalled products should be stored separately from the saleable

stock These can be stored in the expiry cupboard segregated from the expired goods and be appropriately labeled ldquoRecal l e d G o o d s - Not for Salerdquo

The supplier should be notified and asked to replace defective products middot All the details of the procedures followed should be duly recorded in a Recall

Register maintained specially for the purpose The register should include d etails such as -middot Date of the recall middot Nam e of the product

57

bullbull

middot Details of the product (name of manufacturer batch number expiry date) middot Nu m b er of units purchased sold a n d sto c k in ha nd middot Reason for recall middot Nam e of the supplier to whom produc ts w e r e returned along with the date and quantity middot Name and signature of the designated personnel carrying out the recall procedure and recording details middot Name and signature of the chief pharmacist verifying the recall procedures and recording details 4 4 Returned medicines

Medicines may be returned to the pharmacy by clients due to the following reasons -bull

bullbull Unused medicines bullbull Course not completed bullbull Therapy changed by doctor bullbull Side effects experienced by patient bull

bullbull DamagedDefective medicines bullbull Missing or defaced label bullbull Missing tablets in a stripblister bullbull Leakage in bottles bullbull Leakage in strips bull

bullbull Expired medicines

Appropriate SOPs should be framed and followed for their acceptancerefusal and disposal middot bull For unused medicines returned by clients the p harmacy personnel should verify

that these were purchased from their pharmacy They should then be checked for integrity of the packing the dosage form and the expiry date and verified with the client whether they were stored in appropriate conditions This again is at the discretion of each pharmacy

middot The damageddefective medicines returned to the pharmacy should be taken back and stored separately Existing stock of the same product should be checked for similar defects

middot Expired medicines should be accepted from clients at the discretion of the pharmacist and be immediately shifted to the expired goods cupboard These can be stored segregated from the pharmacys own expired goods and be appropriately labelled ldquoExpired Goods returned by clients- Not For Salerdquo

It is advisable not to accept returned medicines requiring cold chain storage (refrigeration) because it cannot be ensured that the cold chain was maintained when the medicines were in the hands of the patientclient middot Appropriate adjustments in t he stocks should be made for medicines

returnedexchanged to update the inventory middot The medicines should then be returned to the respective shelves middot A lsquoReturned Goodsrsquo register needs to be maintained to record all details of returned

medicines

R egister should include such details as-

58

middot N a m e o f t h e p a t i e n t middot Nam e of the product and quantity r e tu r n e d middot Product details such as the batch number and expiry date middot Condition in which received middot Reason for returning products middot Compensatory measures taken wi t h r e s p e c t t o c l i e n t middot Action taken with respect to product middot Name and signature of the personnel accepting the returned medicines and recording details middot Name and signature of the chief pharmacist verifying the recorded details

What the pharmacist would have learnt from this module The storage of medicines is a critical factor in the distribution cycle bullbull Stocks received by the pharmacy should be quarantined in a separate area and necessary checks s h o u ld be performed to ascertain the qua lity a nd quantity of stocks received bullbull Whatever pattern and means of storage used the products should be stored so as to maintain their potency and integrity bullbull Storage conditions should be monitored and maintained on a regular basis bullbull Optimum stock levels should be maintained and regularly monitored for expiry bullbull The design of storage areas should facilitate appropriate storage of medicines bullbull Cleanliness should be maintained in the pharmacy bullbull Adequate measures should be taken in case of returned medicines and recalled products

Optimum storage of medicines is mandatory whether at the distribution stage at the pharmacy or ultimately within the homes of patients The pharmacist has an important r o l e t o p l a y i n t h e s t o r a g e o f m e d i c i n e s i n m a i n t a i n i n g d r u g p o t ency and efficacy and thus facilitating optimum therapeutic benefits Good Pharmacy Practice - IPA -CDSCO - WHO Appendix I Quality Assurance Templates of letters for use if found not of Standard Quality [Frozen and expired goods ]

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated To Name of the Supplier with address

Sub Not of Standard Quality GoMP-Supply of Drugs and medicines-(Codename) Return of Stocks to the Suppliers-reg(New drug policy 2009) Previous letterinvoice ref Sl No Drug Code Drug name

Manufacturing date Expiry date

Supplier address

B a t c h n o

The above items of PO nodated was drawn by the Drug Inspector (Place) on (______________date) as a statutory sampling and declared ldquoNot of Standard

59

Qualityrdquo on -(______________date) by the Government Analyst for the following reasons

- ldquoThe product sample do not confirm to IP specification for (Drug codename with respect to the content of drugrdquo

- ldquoThe product has already been blacklisted by TNMSC on -(______________date) for the failure of (quantity) of batches of drug codenamerdquo

As per the clause of the te nde r d oc um e nt ldquo I f the sa mple s d o not c onf o r m to statutory standardsthe tenderer will be liable for relevant action under the existing laws and the entire stock in such batch should be taken back by the tenderer within a period of 30 days o f t h e r e c e i p t o f t h e l e t t e r f r o m t h e v e n u e

The stock shall be taken back at the expenses of the tendererthe Procurement Authority have the right to destroy such Not of Standard Quality if the tenderer does not take back the goods within the stipulated time

The Procuring Authority will arrange to destroy the Not of Standard Quality drugs within 90 days after the expiry of 30 days mentioned above without further notice and shall also collect demurrage charges calculated at the rate of 2 per week on the value of the drugs rejected till such destructionrdquo

Hence we regret to inform you that you will have to take back the stocks available of the abovesaid batch at your own cost from the drug stores where you have supplied the above batch

Kindly acknowledge the receipt of this reference at once

P r o c u r e m e n t A u t h o r i t y Seal and Stamp

Copy to Ref No dated

1 ) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated13082010

To

Sub Frozen Drugs-ordered to return to the Suppliers-reg(New drug policy 2009) Previous letterinvoice ref

The following products which were earlier frozen have now been ordered to return to suppliers directly with permission from the State drug Authority In this regard the suppliers have been instructed to take back their failed batch from the drug store of the stores Hence you are now instructed to return the following failed batches to the suppliers by obtaining proper authorization letter and acknowledgements from them

60

Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

Kindly acknowledge the receipt of this reference at once

Procurement Authority Seal and Stamp

Copy to

Ref No dated 2) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated14092010

To

Sub Frozen Drugs-ordered to return to the Suppliers- for issue of gate pass after verification reg(New drug policy 2009) Previous letterinvoice ref

The following products which were earlier frozen have now been released Hence they may be issued Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

Kindly acknowledge the receipt of this reference at once

Procurement Authority Seal and Stamp

Copy to

61

Ref No dated 3) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated

To

Sub Stop instruction-reg(New drug policy 2009) Previous letterinvoice ref

Until further instructions stop issue all the batches of the following item Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

You must intimate the available stock in the stores of the said batch Number to the Procurement Authority immediately Also retrieve quantity if already issued

Procurement Authority Seal and Stamp

Copy to

Ref No dated 4) HOD Procurement Office of

62

Appendix II Material handling in drug stores

Rack approx rates and dimensions

S No

Item Description UOM Approx Rate

1 MEDIUM DUTY RACK SIZE 2900 H X 3090 W X 800 D IN MM (AS PER SPECIFICATION)

Each 2499800

2 MEDIUM DUTY RACK ADD ON UNIT FOR SIZE OF SR NO2

Each 2243100

To locate a Box no 3 Rack no 14 in row3

SAMPLE OF RACK no Bin numbering -------------- S a y R K 1 4 R o w 3 B o x 1 6

SAMPLE LAYOUT of RACKS in a Drug Stores

63

Sample of another warehouse of distribution warehouse system

64

65

Slotted Angle racks with bin cards

66

Plastic Pallets

Plastic pallets ar e l i g h t w e i g h t l o w- c ost and exceed industry standards for strength and durability

NOTE A pallet has bottom deckboards (see sketch) A skid does not have bottom

67

deckboards

Battery Operated Stacker

Electric Stacker Ehh (Manual Push Type) - Manual drive - Lifting electrically with Battery 12 V 88 Ah - For loading and un-loading of trucks - Battery and loading device built - in - Battery charge gauge and charging current gauge Simple and Easy Operation - Lifting and Lowering electrically direct on steering arm - Pulling and pushing through steering arm - Electrically operated relief valve on hydraulic aggregate Safe Operation - Emergency Off Switch - Constant lowering speed - Protection through lowering brake valve - Overload protection through overload brake valve - Load chains covered preventing pinching threat - Electrically interlocking during loading process - Secured battery compartment opens upwardly - Stable buffering of the steering arm in upright position - In accordance with EWG Guidelines 89 240 - In accordance with VBG 12b Prevention of Accidents

Pallet Truck [ Top ]

68

----------------------------------------------------------------------------------------------------------------------------

For Transport Of All Goods On Pallets Safe and Easy Operation - through single hand operation Lifting moving

lowering with steering handle - neutral position of the hydraulic possible - overload pressure relief valve Long Service Life - robust co n s t r u c t i o n

- special hardened axles - hardened chromium plated ram - maintenance free Easy Maneuverability - through rubber steering rollers - nylon fork rollers

A h a n d t r o l l e y

69

Trolley with plastic bins for several items del ivery

70

Digital Weighing balances

Balances amp Scales EF Seriers Precision Electronic Balance

71

1

Ice lined Refrigerators

600 litres refrigrator

72

Walk in cooler

vacuum cleaner

73

middot The First Expiry First Out (FEFO) system - In this system the stock having an earlier expiry is sold first The stock with longer shelf life should be placed farthest to the back (or at the bottom in case o f sta c k e d b oxe s) T h is is pa r tic u la r ly impor ta n t with products that have short shelf lives such as vaccines some vitamins antibiotics etc and reduces losses due to expiry

middot E x p i r y dates should be noted on the stock record upon receipt Stock nearing expiry should not be accepted unless it can be used before expiry

Computerization and expiry monitoring In the pharmacy computerization facilitates both checking stocks and expiry mo nitoring and helps-bullbullKeeping a check on products nearing expiry bullbullKeeping a check on non- moving and slow moving products bullbullTo facilitate the removal of medicines nearing expiry from shelves in time to send them back to the wholesaler or supplier

Periodic checking for expiry The expiry date for medicinal products is a critical aspect in pharmaceutical dispensing and due importance should be given to it Periodic checking for expiry of medicines will ensure that the patient will never receive products that have crossed their expiry date During periodical checking of expiry the personnel involved should remove medicines that are nearing expiry bullbullIn -house threshold periods should be set and followed for retrieval of such medicines from the shelves bullbullSuch medicines should be stored separately These should either be dispensed immediately (thus ensuring that they are used before the expiry date) o r t h e y s h o u l d b e returned to the suppliers bullbullA separate area should be designated (cupboard or shelf)marked[FROZEN ZONE] which is adequately marked EXPIRED GOODS- NOT FOR SALE to store all expired stocks FROZEN ZONE

52

Remember Expired medicines are a NATIONAL WASTE So stock only what you can sell Avoid expiries save precious medicines for the nation

Treatment and disposing of expired medicines bullbullProcedures need to be in place for the treatment of expired medicines bullbullThe expired medicines need to be collected and be sent back to the supplier or company for appropriate disposal bullbullRecords must be maintained for expired medicines and how they are disposed off bullbullIn case of medicines that are not returnable to suppliers procedures for disposal need to be followed by the pharmacy in conjunction with the FDA The following procedure can be followed if medicines cannot be returned to suppliers ( T h e b a s i c p h i l o s o p h y of appropriate disposal is to prevent their re- circulation and use) bullbullC u t t h e c o n t ainer in such a manner that the label is also cut In case of tablets and c a p s u l e s d e s t r o y them by disposing them in a bucket of water bullbullUse landfill procedures (deep burial into the ground as per stipulations of Medical Waste Disposal Act prevalent in the respective state) bullbullPour the liquids into the sink and wash away with sufficient quantity of water bullbullKeep a record of such disposal with full details of medicines destroyed Although these measures are usually adopted care has to be taken with such tr e a t m e n t a s studies have shown that flushing of medicines has resulted in tracessmall quantities of medicines being found in waterways and groundwater having potential health and environmental effects

4 O T H E R A S P E C T S 41 Design of storage areas The following important factors need to be considered in design of storage areas -middot The retail outlets in hot areas in summers should be air-conditioned Similarly in

a r e a s o f e x t r e m e c o l d t h e p r e m i s e s w o u l d r e q u i r e w a r m i n g e s p e c i a l l y i n w i n t e r s t o maintain cool temperatures The placement of air -conditioners and heating devices should be such that medicines are not directly exposed to the cold or heat

middot Due consideration should be given to storage requirements of formulations while designing shelves and cupboards in retail outlets Sufficient shelf height should be provided so that all liquid products can be stored vertically As far as possible the shelves should be covered with glass panels to protect medicines from dust and p r e v e n t r a p i d f l u c t u a t i o n s i n temperature

middot Medicines should be stored according to the storage instructions on the labels bullIt is ideal to have a door at the pharmacy entrance to prevent dust from coming in as well as reduceprevent cooled air from going out This may not however be considered feasiblepracticable by many pharmacy owners for fear that clients may not enter the pharmacy because the door may act as a barrier An air curtain is a good alternative to a door

middot There should be minimal direct sunlight falling on the products Particular consideration should be given to premises directly facing the sun

middot bullThe arrangement of lighting in the interior of the premises should also be in a manner that the lights are not focused on the products It has been shown that light causes not only chemical damage but also can catalyze physical changes like moisture uptak e by the products Care should be taken to ensure that only diffused light falls on them

53

middot As far as possible provision should be made for a temperature and humidity indicator device in a pharmacy These devices are now easily available

middot Stability studies o f m e d i c i n e s p a c k e d i n b l i s t e r s h a v e r e v e a l e d t h a t i f t h e s e a r e exposed to light they tend to absorb moisture It is therefore necessary to store them in suitable cartons so that the blisters are not exposed to light Pharmacists should do this even if the manufacturer has not provided cartons

middot Light and temperature sensitive products should not be stored on counters where the light is intense or direct and there is no protection from temperature and humidity

42 Cleaning and maintenance i) Cleaning of storage areas

The storage areas of the pharmacy should be cleaned periodically and cleanliness should be maintained at all times The Standard Operating Procedure for cleaning should be designed and followed accordingly Schedules for cleanups should be laid down and adequate cleaning equipment should be made available

Tips for maintaining cleanliness middot Provide clean pieces of cloth for wiping at various locations in the pharmacy

Replace with clean cloth at regular intervals middot Keep separate pieces of cloth for floors shelves and medicines middot Use a disinfectant andor soap solution to clean floors middot Ensure removal of dust and prevent accumulation of dirt middot Ensure removal of cobwebs middot Use a vacuum cleaner for cleaning areas not easily reachable middot T a k e c a r e t h at breakages are handled and cleared effectively middot Observe the factors leading to waste generation in the pharmacy and take appropriate

measures to tackle the problem middot Record all cleaning procedures performed and maintain all the documents required

For ex a m p l e -bullbullThe floor of the pharmacy may be swept with a broom and swabbed with soap water every morning bullbullThe floor may be swabbed with a disinfectant every week bullbullThe entire premises including shelves and cupboards may be cleaned with a cloth (to remove dust and to check for medicines approaching expiry date or expired medicines) every three months bullbullAll the steps followed should be r e c o r d e d

The floor shelves drawers have to be cleaned and a check should be kept on dust cobwebs spillages due to breakage etc It is therefore essential to have SOPs for cleaning laying down cleaning frequencies allotting responsibilities and maintaining a daily record in the logbook to document all these activities

54

While cleaning dust settled on dosage forms like bottles tubes etc should be removed Before dispensing the products should also be wiped to remove any dust settled during storage

For refrigerators bullbullDefrosting and cleaning should be done at regular intervals bullbullSwitch off the refrigerator while cleaning bullbullCleaning should be done quickly and stocks put back immediately

i i ) Pest control Pests are a serious problem in India where insects reptiles and rodents (eg cockroaches l i z a r d s r a t s s i l v e r f i s h (Deemak - in Hindi ) etc) may find access to the pharmacy storage areas Insects like ants and borer ants may often attack wood in the pharmacy causing d am ag e to shelves cupboardsPest c ontr o l in a p h a r m a c y c a n b e a d i f f i c u l t t a s k b u t t o avoid possible contamination and physical damage to stock it is necessary to keep pests out of the pharmacy premisesPest control measures should be implemented with proper p r e c a u t i o n s t a k i n g u t m o s t c a r e t o a v o i d contamination of medicines

55

Th e following pest control measures c a n be ta ke n f r om tim e to tim e -bullbullRat bait and traps can be placed at various locations bullbullInsecticutors can be used on a permanent basis bullbullInsecticidal sprays and repellants can be used from time to time

i i i ) Fire precautions

Combustible trash such as cartons boxes and other packing waste must not be allowed to accumulate in the store Waste should be deposited in appropriate waste bins and be d i s p o s e d o f f o n a d a i l y b a s i s

F i re detection and fire fighting equipment must be maintained and regularly inspected The pharmacy personnel should receive adequate training in fire fighting techniques and emergency actionFire prevention measures should include a prominently displayed ldquoNoSmokingrdquo sign careful handling and disposal of combustible waste materials and checking of electrical connections at regular intervals

iv) Security middot Doors shutters of the pharmacy should be strong and be fitted with secure locks middot Counters should be designed so that unauthorized personnelclients do not have

access to areas where prescription medicines are stored Access to such areas should be restricted to the pharmacy staff

middot All the pharmacy staff handling supplies should be accountable for their ac t i o n s

56

middot bullSpecial care must be taken in case of Schedule X and manufactured drugs (under NDPS Act) Such medicines should be kept under lock and key and the key should be kept with the Chief Pharmacist or i n h i s a b s e n c e t h e s e n i o r p h a r m a c i s t

v) Breakagespillage and damaged product Products that have been damagedspoiled during storage and handling spillages and broken glassware should be disposed off according to procedures laid down by the pharmacy Broken and damaged products s h o u l d b e p l a c e d i n a segregated area to be returned to the supplier

vi) Inspection Senior staff should inspect all pharmacy areas regularly The shelves and drawers should b e c h e c k e d d a i l y f o r signs of pests and dust Ceiling and walls should be checked for dirt and cobwebs Stock should be checked on a regular basis for deterioration due to climatic conditions

43 Product recalls Products found to be defective should be quickly recalled (withdrawn from the market) The instructions are generally issued either by the manufacturer or the regulatory agency The level of recall is determined by both the degree of risk and the extent of distribution of the product and in India is mainly directed at the distribution chain

On receiving the details of the defective substandard spurious batchbatches of a medicine to be recalled from the manufacturer or the stockist or the FDA the pharmacy should immediately check if the particular b a t c h i s i n s t o c k a n d i f s o s u s p e n d i t s s a l e immediately

Similarly if the regulatory authority in the country bans a particular medicine or FDC the pharmacy should immediately check and remove all the different brands of that particular medicine under consideration

The details of medicines and their batches to be recalled should be available in the q u a r a n t i n e a r e a w h e r e stocks are received and checked This is to ensure that such medicines do not come into the pharmacy

middot The pharmacy should develop SOPs for recall of medicines middot The pharmacy staff should be immediately informed about such medicines and

the details should be displayed in writing in a prominent place in the pharmacy middot Rapid action helps avoid unnecessary exposure to such medicines once the

problem has been d e t e c t e d middot The progress of the recall procedure in the pharmacy should be monitored every

few days to ensure complete compliance middot All stocks of the recalled products should be stored separately from the saleable

stock These can be stored in the expiry cupboard segregated from the expired goods and be appropriately labeled ldquoRecal l e d G o o d s - Not for Salerdquo

The supplier should be notified and asked to replace defective products middot All the details of the procedures followed should be duly recorded in a Recall

Register maintained specially for the purpose The register should include d etails such as -middot Date of the recall middot Nam e of the product

57

bullbull

middot Details of the product (name of manufacturer batch number expiry date) middot Nu m b er of units purchased sold a n d sto c k in ha nd middot Reason for recall middot Nam e of the supplier to whom produc ts w e r e returned along with the date and quantity middot Name and signature of the designated personnel carrying out the recall procedure and recording details middot Name and signature of the chief pharmacist verifying the recall procedures and recording details 4 4 Returned medicines

Medicines may be returned to the pharmacy by clients due to the following reasons -bull

bullbull Unused medicines bullbull Course not completed bullbull Therapy changed by doctor bullbull Side effects experienced by patient bull

bullbull DamagedDefective medicines bullbull Missing or defaced label bullbull Missing tablets in a stripblister bullbull Leakage in bottles bullbull Leakage in strips bull

bullbull Expired medicines

Appropriate SOPs should be framed and followed for their acceptancerefusal and disposal middot bull For unused medicines returned by clients the p harmacy personnel should verify

that these were purchased from their pharmacy They should then be checked for integrity of the packing the dosage form and the expiry date and verified with the client whether they were stored in appropriate conditions This again is at the discretion of each pharmacy

middot The damageddefective medicines returned to the pharmacy should be taken back and stored separately Existing stock of the same product should be checked for similar defects

middot Expired medicines should be accepted from clients at the discretion of the pharmacist and be immediately shifted to the expired goods cupboard These can be stored segregated from the pharmacys own expired goods and be appropriately labelled ldquoExpired Goods returned by clients- Not For Salerdquo

It is advisable not to accept returned medicines requiring cold chain storage (refrigeration) because it cannot be ensured that the cold chain was maintained when the medicines were in the hands of the patientclient middot Appropriate adjustments in t he stocks should be made for medicines

returnedexchanged to update the inventory middot The medicines should then be returned to the respective shelves middot A lsquoReturned Goodsrsquo register needs to be maintained to record all details of returned

medicines

R egister should include such details as-

58

middot N a m e o f t h e p a t i e n t middot Nam e of the product and quantity r e tu r n e d middot Product details such as the batch number and expiry date middot Condition in which received middot Reason for returning products middot Compensatory measures taken wi t h r e s p e c t t o c l i e n t middot Action taken with respect to product middot Name and signature of the personnel accepting the returned medicines and recording details middot Name and signature of the chief pharmacist verifying the recorded details

What the pharmacist would have learnt from this module The storage of medicines is a critical factor in the distribution cycle bullbull Stocks received by the pharmacy should be quarantined in a separate area and necessary checks s h o u ld be performed to ascertain the qua lity a nd quantity of stocks received bullbull Whatever pattern and means of storage used the products should be stored so as to maintain their potency and integrity bullbull Storage conditions should be monitored and maintained on a regular basis bullbull Optimum stock levels should be maintained and regularly monitored for expiry bullbull The design of storage areas should facilitate appropriate storage of medicines bullbull Cleanliness should be maintained in the pharmacy bullbull Adequate measures should be taken in case of returned medicines and recalled products

Optimum storage of medicines is mandatory whether at the distribution stage at the pharmacy or ultimately within the homes of patients The pharmacist has an important r o l e t o p l a y i n t h e s t o r a g e o f m e d i c i n e s i n m a i n t a i n i n g d r u g p o t ency and efficacy and thus facilitating optimum therapeutic benefits Good Pharmacy Practice - IPA -CDSCO - WHO Appendix I Quality Assurance Templates of letters for use if found not of Standard Quality [Frozen and expired goods ]

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated To Name of the Supplier with address

Sub Not of Standard Quality GoMP-Supply of Drugs and medicines-(Codename) Return of Stocks to the Suppliers-reg(New drug policy 2009) Previous letterinvoice ref Sl No Drug Code Drug name

Manufacturing date Expiry date

Supplier address

B a t c h n o

The above items of PO nodated was drawn by the Drug Inspector (Place) on (______________date) as a statutory sampling and declared ldquoNot of Standard

59

Qualityrdquo on -(______________date) by the Government Analyst for the following reasons

- ldquoThe product sample do not confirm to IP specification for (Drug codename with respect to the content of drugrdquo

- ldquoThe product has already been blacklisted by TNMSC on -(______________date) for the failure of (quantity) of batches of drug codenamerdquo

As per the clause of the te nde r d oc um e nt ldquo I f the sa mple s d o not c onf o r m to statutory standardsthe tenderer will be liable for relevant action under the existing laws and the entire stock in such batch should be taken back by the tenderer within a period of 30 days o f t h e r e c e i p t o f t h e l e t t e r f r o m t h e v e n u e

The stock shall be taken back at the expenses of the tendererthe Procurement Authority have the right to destroy such Not of Standard Quality if the tenderer does not take back the goods within the stipulated time

The Procuring Authority will arrange to destroy the Not of Standard Quality drugs within 90 days after the expiry of 30 days mentioned above without further notice and shall also collect demurrage charges calculated at the rate of 2 per week on the value of the drugs rejected till such destructionrdquo

Hence we regret to inform you that you will have to take back the stocks available of the abovesaid batch at your own cost from the drug stores where you have supplied the above batch

Kindly acknowledge the receipt of this reference at once

P r o c u r e m e n t A u t h o r i t y Seal and Stamp

Copy to Ref No dated

1 ) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated13082010

To

Sub Frozen Drugs-ordered to return to the Suppliers-reg(New drug policy 2009) Previous letterinvoice ref

The following products which were earlier frozen have now been ordered to return to suppliers directly with permission from the State drug Authority In this regard the suppliers have been instructed to take back their failed batch from the drug store of the stores Hence you are now instructed to return the following failed batches to the suppliers by obtaining proper authorization letter and acknowledgements from them

60

Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

Kindly acknowledge the receipt of this reference at once

Procurement Authority Seal and Stamp

Copy to

Ref No dated 2) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated14092010

To

Sub Frozen Drugs-ordered to return to the Suppliers- for issue of gate pass after verification reg(New drug policy 2009) Previous letterinvoice ref

The following products which were earlier frozen have now been released Hence they may be issued Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

Kindly acknowledge the receipt of this reference at once

Procurement Authority Seal and Stamp

Copy to

61

Ref No dated 3) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated

To

Sub Stop instruction-reg(New drug policy 2009) Previous letterinvoice ref

Until further instructions stop issue all the batches of the following item Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

You must intimate the available stock in the stores of the said batch Number to the Procurement Authority immediately Also retrieve quantity if already issued

Procurement Authority Seal and Stamp

Copy to

Ref No dated 4) HOD Procurement Office of

62

Appendix II Material handling in drug stores

Rack approx rates and dimensions

S No

Item Description UOM Approx Rate

1 MEDIUM DUTY RACK SIZE 2900 H X 3090 W X 800 D IN MM (AS PER SPECIFICATION)

Each 2499800

2 MEDIUM DUTY RACK ADD ON UNIT FOR SIZE OF SR NO2

Each 2243100

To locate a Box no 3 Rack no 14 in row3

SAMPLE OF RACK no Bin numbering -------------- S a y R K 1 4 R o w 3 B o x 1 6

SAMPLE LAYOUT of RACKS in a Drug Stores

63

Sample of another warehouse of distribution warehouse system

64

65

Slotted Angle racks with bin cards

66

Plastic Pallets

Plastic pallets ar e l i g h t w e i g h t l o w- c ost and exceed industry standards for strength and durability

NOTE A pallet has bottom deckboards (see sketch) A skid does not have bottom

67

deckboards

Battery Operated Stacker

Electric Stacker Ehh (Manual Push Type) - Manual drive - Lifting electrically with Battery 12 V 88 Ah - For loading and un-loading of trucks - Battery and loading device built - in - Battery charge gauge and charging current gauge Simple and Easy Operation - Lifting and Lowering electrically direct on steering arm - Pulling and pushing through steering arm - Electrically operated relief valve on hydraulic aggregate Safe Operation - Emergency Off Switch - Constant lowering speed - Protection through lowering brake valve - Overload protection through overload brake valve - Load chains covered preventing pinching threat - Electrically interlocking during loading process - Secured battery compartment opens upwardly - Stable buffering of the steering arm in upright position - In accordance with EWG Guidelines 89 240 - In accordance with VBG 12b Prevention of Accidents

Pallet Truck [ Top ]

68

----------------------------------------------------------------------------------------------------------------------------

For Transport Of All Goods On Pallets Safe and Easy Operation - through single hand operation Lifting moving

lowering with steering handle - neutral position of the hydraulic possible - overload pressure relief valve Long Service Life - robust co n s t r u c t i o n

- special hardened axles - hardened chromium plated ram - maintenance free Easy Maneuverability - through rubber steering rollers - nylon fork rollers

A h a n d t r o l l e y

69

Trolley with plastic bins for several items del ivery

70

Digital Weighing balances

Balances amp Scales EF Seriers Precision Electronic Balance

71

1

Ice lined Refrigerators

600 litres refrigrator

72

Walk in cooler

vacuum cleaner

73

Remember Expired medicines are a NATIONAL WASTE So stock only what you can sell Avoid expiries save precious medicines for the nation

Treatment and disposing of expired medicines bullbullProcedures need to be in place for the treatment of expired medicines bullbullThe expired medicines need to be collected and be sent back to the supplier or company for appropriate disposal bullbullRecords must be maintained for expired medicines and how they are disposed off bullbullIn case of medicines that are not returnable to suppliers procedures for disposal need to be followed by the pharmacy in conjunction with the FDA The following procedure can be followed if medicines cannot be returned to suppliers ( T h e b a s i c p h i l o s o p h y of appropriate disposal is to prevent their re- circulation and use) bullbullC u t t h e c o n t ainer in such a manner that the label is also cut In case of tablets and c a p s u l e s d e s t r o y them by disposing them in a bucket of water bullbullUse landfill procedures (deep burial into the ground as per stipulations of Medical Waste Disposal Act prevalent in the respective state) bullbullPour the liquids into the sink and wash away with sufficient quantity of water bullbullKeep a record of such disposal with full details of medicines destroyed Although these measures are usually adopted care has to be taken with such tr e a t m e n t a s studies have shown that flushing of medicines has resulted in tracessmall quantities of medicines being found in waterways and groundwater having potential health and environmental effects

4 O T H E R A S P E C T S 41 Design of storage areas The following important factors need to be considered in design of storage areas -middot The retail outlets in hot areas in summers should be air-conditioned Similarly in

a r e a s o f e x t r e m e c o l d t h e p r e m i s e s w o u l d r e q u i r e w a r m i n g e s p e c i a l l y i n w i n t e r s t o maintain cool temperatures The placement of air -conditioners and heating devices should be such that medicines are not directly exposed to the cold or heat

middot Due consideration should be given to storage requirements of formulations while designing shelves and cupboards in retail outlets Sufficient shelf height should be provided so that all liquid products can be stored vertically As far as possible the shelves should be covered with glass panels to protect medicines from dust and p r e v e n t r a p i d f l u c t u a t i o n s i n temperature

middot Medicines should be stored according to the storage instructions on the labels bullIt is ideal to have a door at the pharmacy entrance to prevent dust from coming in as well as reduceprevent cooled air from going out This may not however be considered feasiblepracticable by many pharmacy owners for fear that clients may not enter the pharmacy because the door may act as a barrier An air curtain is a good alternative to a door

middot There should be minimal direct sunlight falling on the products Particular consideration should be given to premises directly facing the sun

middot bullThe arrangement of lighting in the interior of the premises should also be in a manner that the lights are not focused on the products It has been shown that light causes not only chemical damage but also can catalyze physical changes like moisture uptak e by the products Care should be taken to ensure that only diffused light falls on them

53

middot As far as possible provision should be made for a temperature and humidity indicator device in a pharmacy These devices are now easily available

middot Stability studies o f m e d i c i n e s p a c k e d i n b l i s t e r s h a v e r e v e a l e d t h a t i f t h e s e a r e exposed to light they tend to absorb moisture It is therefore necessary to store them in suitable cartons so that the blisters are not exposed to light Pharmacists should do this even if the manufacturer has not provided cartons

middot Light and temperature sensitive products should not be stored on counters where the light is intense or direct and there is no protection from temperature and humidity

42 Cleaning and maintenance i) Cleaning of storage areas

The storage areas of the pharmacy should be cleaned periodically and cleanliness should be maintained at all times The Standard Operating Procedure for cleaning should be designed and followed accordingly Schedules for cleanups should be laid down and adequate cleaning equipment should be made available

Tips for maintaining cleanliness middot Provide clean pieces of cloth for wiping at various locations in the pharmacy

Replace with clean cloth at regular intervals middot Keep separate pieces of cloth for floors shelves and medicines middot Use a disinfectant andor soap solution to clean floors middot Ensure removal of dust and prevent accumulation of dirt middot Ensure removal of cobwebs middot Use a vacuum cleaner for cleaning areas not easily reachable middot T a k e c a r e t h at breakages are handled and cleared effectively middot Observe the factors leading to waste generation in the pharmacy and take appropriate

measures to tackle the problem middot Record all cleaning procedures performed and maintain all the documents required

For ex a m p l e -bullbullThe floor of the pharmacy may be swept with a broom and swabbed with soap water every morning bullbullThe floor may be swabbed with a disinfectant every week bullbullThe entire premises including shelves and cupboards may be cleaned with a cloth (to remove dust and to check for medicines approaching expiry date or expired medicines) every three months bullbullAll the steps followed should be r e c o r d e d

The floor shelves drawers have to be cleaned and a check should be kept on dust cobwebs spillages due to breakage etc It is therefore essential to have SOPs for cleaning laying down cleaning frequencies allotting responsibilities and maintaining a daily record in the logbook to document all these activities

54

While cleaning dust settled on dosage forms like bottles tubes etc should be removed Before dispensing the products should also be wiped to remove any dust settled during storage

For refrigerators bullbullDefrosting and cleaning should be done at regular intervals bullbullSwitch off the refrigerator while cleaning bullbullCleaning should be done quickly and stocks put back immediately

i i ) Pest control Pests are a serious problem in India where insects reptiles and rodents (eg cockroaches l i z a r d s r a t s s i l v e r f i s h (Deemak - in Hindi ) etc) may find access to the pharmacy storage areas Insects like ants and borer ants may often attack wood in the pharmacy causing d am ag e to shelves cupboardsPest c ontr o l in a p h a r m a c y c a n b e a d i f f i c u l t t a s k b u t t o avoid possible contamination and physical damage to stock it is necessary to keep pests out of the pharmacy premisesPest control measures should be implemented with proper p r e c a u t i o n s t a k i n g u t m o s t c a r e t o a v o i d contamination of medicines

55

Th e following pest control measures c a n be ta ke n f r om tim e to tim e -bullbullRat bait and traps can be placed at various locations bullbullInsecticutors can be used on a permanent basis bullbullInsecticidal sprays and repellants can be used from time to time

i i i ) Fire precautions

Combustible trash such as cartons boxes and other packing waste must not be allowed to accumulate in the store Waste should be deposited in appropriate waste bins and be d i s p o s e d o f f o n a d a i l y b a s i s

F i re detection and fire fighting equipment must be maintained and regularly inspected The pharmacy personnel should receive adequate training in fire fighting techniques and emergency actionFire prevention measures should include a prominently displayed ldquoNoSmokingrdquo sign careful handling and disposal of combustible waste materials and checking of electrical connections at regular intervals

iv) Security middot Doors shutters of the pharmacy should be strong and be fitted with secure locks middot Counters should be designed so that unauthorized personnelclients do not have

access to areas where prescription medicines are stored Access to such areas should be restricted to the pharmacy staff

middot All the pharmacy staff handling supplies should be accountable for their ac t i o n s

56

middot bullSpecial care must be taken in case of Schedule X and manufactured drugs (under NDPS Act) Such medicines should be kept under lock and key and the key should be kept with the Chief Pharmacist or i n h i s a b s e n c e t h e s e n i o r p h a r m a c i s t

v) Breakagespillage and damaged product Products that have been damagedspoiled during storage and handling spillages and broken glassware should be disposed off according to procedures laid down by the pharmacy Broken and damaged products s h o u l d b e p l a c e d i n a segregated area to be returned to the supplier

vi) Inspection Senior staff should inspect all pharmacy areas regularly The shelves and drawers should b e c h e c k e d d a i l y f o r signs of pests and dust Ceiling and walls should be checked for dirt and cobwebs Stock should be checked on a regular basis for deterioration due to climatic conditions

43 Product recalls Products found to be defective should be quickly recalled (withdrawn from the market) The instructions are generally issued either by the manufacturer or the regulatory agency The level of recall is determined by both the degree of risk and the extent of distribution of the product and in India is mainly directed at the distribution chain

On receiving the details of the defective substandard spurious batchbatches of a medicine to be recalled from the manufacturer or the stockist or the FDA the pharmacy should immediately check if the particular b a t c h i s i n s t o c k a n d i f s o s u s p e n d i t s s a l e immediately

Similarly if the regulatory authority in the country bans a particular medicine or FDC the pharmacy should immediately check and remove all the different brands of that particular medicine under consideration

The details of medicines and their batches to be recalled should be available in the q u a r a n t i n e a r e a w h e r e stocks are received and checked This is to ensure that such medicines do not come into the pharmacy

middot The pharmacy should develop SOPs for recall of medicines middot The pharmacy staff should be immediately informed about such medicines and

the details should be displayed in writing in a prominent place in the pharmacy middot Rapid action helps avoid unnecessary exposure to such medicines once the

problem has been d e t e c t e d middot The progress of the recall procedure in the pharmacy should be monitored every

few days to ensure complete compliance middot All stocks of the recalled products should be stored separately from the saleable

stock These can be stored in the expiry cupboard segregated from the expired goods and be appropriately labeled ldquoRecal l e d G o o d s - Not for Salerdquo

The supplier should be notified and asked to replace defective products middot All the details of the procedures followed should be duly recorded in a Recall

Register maintained specially for the purpose The register should include d etails such as -middot Date of the recall middot Nam e of the product

57

bullbull

middot Details of the product (name of manufacturer batch number expiry date) middot Nu m b er of units purchased sold a n d sto c k in ha nd middot Reason for recall middot Nam e of the supplier to whom produc ts w e r e returned along with the date and quantity middot Name and signature of the designated personnel carrying out the recall procedure and recording details middot Name and signature of the chief pharmacist verifying the recall procedures and recording details 4 4 Returned medicines

Medicines may be returned to the pharmacy by clients due to the following reasons -bull

bullbull Unused medicines bullbull Course not completed bullbull Therapy changed by doctor bullbull Side effects experienced by patient bull

bullbull DamagedDefective medicines bullbull Missing or defaced label bullbull Missing tablets in a stripblister bullbull Leakage in bottles bullbull Leakage in strips bull

bullbull Expired medicines

Appropriate SOPs should be framed and followed for their acceptancerefusal and disposal middot bull For unused medicines returned by clients the p harmacy personnel should verify

that these were purchased from their pharmacy They should then be checked for integrity of the packing the dosage form and the expiry date and verified with the client whether they were stored in appropriate conditions This again is at the discretion of each pharmacy

middot The damageddefective medicines returned to the pharmacy should be taken back and stored separately Existing stock of the same product should be checked for similar defects

middot Expired medicines should be accepted from clients at the discretion of the pharmacist and be immediately shifted to the expired goods cupboard These can be stored segregated from the pharmacys own expired goods and be appropriately labelled ldquoExpired Goods returned by clients- Not For Salerdquo

It is advisable not to accept returned medicines requiring cold chain storage (refrigeration) because it cannot be ensured that the cold chain was maintained when the medicines were in the hands of the patientclient middot Appropriate adjustments in t he stocks should be made for medicines

returnedexchanged to update the inventory middot The medicines should then be returned to the respective shelves middot A lsquoReturned Goodsrsquo register needs to be maintained to record all details of returned

medicines

R egister should include such details as-

58

middot N a m e o f t h e p a t i e n t middot Nam e of the product and quantity r e tu r n e d middot Product details such as the batch number and expiry date middot Condition in which received middot Reason for returning products middot Compensatory measures taken wi t h r e s p e c t t o c l i e n t middot Action taken with respect to product middot Name and signature of the personnel accepting the returned medicines and recording details middot Name and signature of the chief pharmacist verifying the recorded details

What the pharmacist would have learnt from this module The storage of medicines is a critical factor in the distribution cycle bullbull Stocks received by the pharmacy should be quarantined in a separate area and necessary checks s h o u ld be performed to ascertain the qua lity a nd quantity of stocks received bullbull Whatever pattern and means of storage used the products should be stored so as to maintain their potency and integrity bullbull Storage conditions should be monitored and maintained on a regular basis bullbull Optimum stock levels should be maintained and regularly monitored for expiry bullbull The design of storage areas should facilitate appropriate storage of medicines bullbull Cleanliness should be maintained in the pharmacy bullbull Adequate measures should be taken in case of returned medicines and recalled products

Optimum storage of medicines is mandatory whether at the distribution stage at the pharmacy or ultimately within the homes of patients The pharmacist has an important r o l e t o p l a y i n t h e s t o r a g e o f m e d i c i n e s i n m a i n t a i n i n g d r u g p o t ency and efficacy and thus facilitating optimum therapeutic benefits Good Pharmacy Practice - IPA -CDSCO - WHO Appendix I Quality Assurance Templates of letters for use if found not of Standard Quality [Frozen and expired goods ]

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated To Name of the Supplier with address

Sub Not of Standard Quality GoMP-Supply of Drugs and medicines-(Codename) Return of Stocks to the Suppliers-reg(New drug policy 2009) Previous letterinvoice ref Sl No Drug Code Drug name

Manufacturing date Expiry date

Supplier address

B a t c h n o

The above items of PO nodated was drawn by the Drug Inspector (Place) on (______________date) as a statutory sampling and declared ldquoNot of Standard

59

Qualityrdquo on -(______________date) by the Government Analyst for the following reasons

- ldquoThe product sample do not confirm to IP specification for (Drug codename with respect to the content of drugrdquo

- ldquoThe product has already been blacklisted by TNMSC on -(______________date) for the failure of (quantity) of batches of drug codenamerdquo

As per the clause of the te nde r d oc um e nt ldquo I f the sa mple s d o not c onf o r m to statutory standardsthe tenderer will be liable for relevant action under the existing laws and the entire stock in such batch should be taken back by the tenderer within a period of 30 days o f t h e r e c e i p t o f t h e l e t t e r f r o m t h e v e n u e

The stock shall be taken back at the expenses of the tendererthe Procurement Authority have the right to destroy such Not of Standard Quality if the tenderer does not take back the goods within the stipulated time

The Procuring Authority will arrange to destroy the Not of Standard Quality drugs within 90 days after the expiry of 30 days mentioned above without further notice and shall also collect demurrage charges calculated at the rate of 2 per week on the value of the drugs rejected till such destructionrdquo

Hence we regret to inform you that you will have to take back the stocks available of the abovesaid batch at your own cost from the drug stores where you have supplied the above batch

Kindly acknowledge the receipt of this reference at once

P r o c u r e m e n t A u t h o r i t y Seal and Stamp

Copy to Ref No dated

1 ) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated13082010

To

Sub Frozen Drugs-ordered to return to the Suppliers-reg(New drug policy 2009) Previous letterinvoice ref

The following products which were earlier frozen have now been ordered to return to suppliers directly with permission from the State drug Authority In this regard the suppliers have been instructed to take back their failed batch from the drug store of the stores Hence you are now instructed to return the following failed batches to the suppliers by obtaining proper authorization letter and acknowledgements from them

60

Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

Kindly acknowledge the receipt of this reference at once

Procurement Authority Seal and Stamp

Copy to

Ref No dated 2) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated14092010

To

Sub Frozen Drugs-ordered to return to the Suppliers- for issue of gate pass after verification reg(New drug policy 2009) Previous letterinvoice ref

The following products which were earlier frozen have now been released Hence they may be issued Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

Kindly acknowledge the receipt of this reference at once

Procurement Authority Seal and Stamp

Copy to

61

Ref No dated 3) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated

To

Sub Stop instruction-reg(New drug policy 2009) Previous letterinvoice ref

Until further instructions stop issue all the batches of the following item Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

You must intimate the available stock in the stores of the said batch Number to the Procurement Authority immediately Also retrieve quantity if already issued

Procurement Authority Seal and Stamp

Copy to

Ref No dated 4) HOD Procurement Office of

62

Appendix II Material handling in drug stores

Rack approx rates and dimensions

S No

Item Description UOM Approx Rate

1 MEDIUM DUTY RACK SIZE 2900 H X 3090 W X 800 D IN MM (AS PER SPECIFICATION)

Each 2499800

2 MEDIUM DUTY RACK ADD ON UNIT FOR SIZE OF SR NO2

Each 2243100

To locate a Box no 3 Rack no 14 in row3

SAMPLE OF RACK no Bin numbering -------------- S a y R K 1 4 R o w 3 B o x 1 6

SAMPLE LAYOUT of RACKS in a Drug Stores

63

Sample of another warehouse of distribution warehouse system

64

65

Slotted Angle racks with bin cards

66

Plastic Pallets

Plastic pallets ar e l i g h t w e i g h t l o w- c ost and exceed industry standards for strength and durability

NOTE A pallet has bottom deckboards (see sketch) A skid does not have bottom

67

deckboards

Battery Operated Stacker

Electric Stacker Ehh (Manual Push Type) - Manual drive - Lifting electrically with Battery 12 V 88 Ah - For loading and un-loading of trucks - Battery and loading device built - in - Battery charge gauge and charging current gauge Simple and Easy Operation - Lifting and Lowering electrically direct on steering arm - Pulling and pushing through steering arm - Electrically operated relief valve on hydraulic aggregate Safe Operation - Emergency Off Switch - Constant lowering speed - Protection through lowering brake valve - Overload protection through overload brake valve - Load chains covered preventing pinching threat - Electrically interlocking during loading process - Secured battery compartment opens upwardly - Stable buffering of the steering arm in upright position - In accordance with EWG Guidelines 89 240 - In accordance with VBG 12b Prevention of Accidents

Pallet Truck [ Top ]

68

----------------------------------------------------------------------------------------------------------------------------

For Transport Of All Goods On Pallets Safe and Easy Operation - through single hand operation Lifting moving

lowering with steering handle - neutral position of the hydraulic possible - overload pressure relief valve Long Service Life - robust co n s t r u c t i o n

- special hardened axles - hardened chromium plated ram - maintenance free Easy Maneuverability - through rubber steering rollers - nylon fork rollers

A h a n d t r o l l e y

69

Trolley with plastic bins for several items del ivery

70

Digital Weighing balances

Balances amp Scales EF Seriers Precision Electronic Balance

71

1

Ice lined Refrigerators

600 litres refrigrator

72

Walk in cooler

vacuum cleaner

73

middot As far as possible provision should be made for a temperature and humidity indicator device in a pharmacy These devices are now easily available

middot Stability studies o f m e d i c i n e s p a c k e d i n b l i s t e r s h a v e r e v e a l e d t h a t i f t h e s e a r e exposed to light they tend to absorb moisture It is therefore necessary to store them in suitable cartons so that the blisters are not exposed to light Pharmacists should do this even if the manufacturer has not provided cartons

middot Light and temperature sensitive products should not be stored on counters where the light is intense or direct and there is no protection from temperature and humidity

42 Cleaning and maintenance i) Cleaning of storage areas

The storage areas of the pharmacy should be cleaned periodically and cleanliness should be maintained at all times The Standard Operating Procedure for cleaning should be designed and followed accordingly Schedules for cleanups should be laid down and adequate cleaning equipment should be made available

Tips for maintaining cleanliness middot Provide clean pieces of cloth for wiping at various locations in the pharmacy

Replace with clean cloth at regular intervals middot Keep separate pieces of cloth for floors shelves and medicines middot Use a disinfectant andor soap solution to clean floors middot Ensure removal of dust and prevent accumulation of dirt middot Ensure removal of cobwebs middot Use a vacuum cleaner for cleaning areas not easily reachable middot T a k e c a r e t h at breakages are handled and cleared effectively middot Observe the factors leading to waste generation in the pharmacy and take appropriate

measures to tackle the problem middot Record all cleaning procedures performed and maintain all the documents required

For ex a m p l e -bullbullThe floor of the pharmacy may be swept with a broom and swabbed with soap water every morning bullbullThe floor may be swabbed with a disinfectant every week bullbullThe entire premises including shelves and cupboards may be cleaned with a cloth (to remove dust and to check for medicines approaching expiry date or expired medicines) every three months bullbullAll the steps followed should be r e c o r d e d

The floor shelves drawers have to be cleaned and a check should be kept on dust cobwebs spillages due to breakage etc It is therefore essential to have SOPs for cleaning laying down cleaning frequencies allotting responsibilities and maintaining a daily record in the logbook to document all these activities

54

While cleaning dust settled on dosage forms like bottles tubes etc should be removed Before dispensing the products should also be wiped to remove any dust settled during storage

For refrigerators bullbullDefrosting and cleaning should be done at regular intervals bullbullSwitch off the refrigerator while cleaning bullbullCleaning should be done quickly and stocks put back immediately

i i ) Pest control Pests are a serious problem in India where insects reptiles and rodents (eg cockroaches l i z a r d s r a t s s i l v e r f i s h (Deemak - in Hindi ) etc) may find access to the pharmacy storage areas Insects like ants and borer ants may often attack wood in the pharmacy causing d am ag e to shelves cupboardsPest c ontr o l in a p h a r m a c y c a n b e a d i f f i c u l t t a s k b u t t o avoid possible contamination and physical damage to stock it is necessary to keep pests out of the pharmacy premisesPest control measures should be implemented with proper p r e c a u t i o n s t a k i n g u t m o s t c a r e t o a v o i d contamination of medicines

55

Th e following pest control measures c a n be ta ke n f r om tim e to tim e -bullbullRat bait and traps can be placed at various locations bullbullInsecticutors can be used on a permanent basis bullbullInsecticidal sprays and repellants can be used from time to time

i i i ) Fire precautions

Combustible trash such as cartons boxes and other packing waste must not be allowed to accumulate in the store Waste should be deposited in appropriate waste bins and be d i s p o s e d o f f o n a d a i l y b a s i s

F i re detection and fire fighting equipment must be maintained and regularly inspected The pharmacy personnel should receive adequate training in fire fighting techniques and emergency actionFire prevention measures should include a prominently displayed ldquoNoSmokingrdquo sign careful handling and disposal of combustible waste materials and checking of electrical connections at regular intervals

iv) Security middot Doors shutters of the pharmacy should be strong and be fitted with secure locks middot Counters should be designed so that unauthorized personnelclients do not have

access to areas where prescription medicines are stored Access to such areas should be restricted to the pharmacy staff

middot All the pharmacy staff handling supplies should be accountable for their ac t i o n s

56

middot bullSpecial care must be taken in case of Schedule X and manufactured drugs (under NDPS Act) Such medicines should be kept under lock and key and the key should be kept with the Chief Pharmacist or i n h i s a b s e n c e t h e s e n i o r p h a r m a c i s t

v) Breakagespillage and damaged product Products that have been damagedspoiled during storage and handling spillages and broken glassware should be disposed off according to procedures laid down by the pharmacy Broken and damaged products s h o u l d b e p l a c e d i n a segregated area to be returned to the supplier

vi) Inspection Senior staff should inspect all pharmacy areas regularly The shelves and drawers should b e c h e c k e d d a i l y f o r signs of pests and dust Ceiling and walls should be checked for dirt and cobwebs Stock should be checked on a regular basis for deterioration due to climatic conditions

43 Product recalls Products found to be defective should be quickly recalled (withdrawn from the market) The instructions are generally issued either by the manufacturer or the regulatory agency The level of recall is determined by both the degree of risk and the extent of distribution of the product and in India is mainly directed at the distribution chain

On receiving the details of the defective substandard spurious batchbatches of a medicine to be recalled from the manufacturer or the stockist or the FDA the pharmacy should immediately check if the particular b a t c h i s i n s t o c k a n d i f s o s u s p e n d i t s s a l e immediately

Similarly if the regulatory authority in the country bans a particular medicine or FDC the pharmacy should immediately check and remove all the different brands of that particular medicine under consideration

The details of medicines and their batches to be recalled should be available in the q u a r a n t i n e a r e a w h e r e stocks are received and checked This is to ensure that such medicines do not come into the pharmacy

middot The pharmacy should develop SOPs for recall of medicines middot The pharmacy staff should be immediately informed about such medicines and

the details should be displayed in writing in a prominent place in the pharmacy middot Rapid action helps avoid unnecessary exposure to such medicines once the

problem has been d e t e c t e d middot The progress of the recall procedure in the pharmacy should be monitored every

few days to ensure complete compliance middot All stocks of the recalled products should be stored separately from the saleable

stock These can be stored in the expiry cupboard segregated from the expired goods and be appropriately labeled ldquoRecal l e d G o o d s - Not for Salerdquo

The supplier should be notified and asked to replace defective products middot All the details of the procedures followed should be duly recorded in a Recall

Register maintained specially for the purpose The register should include d etails such as -middot Date of the recall middot Nam e of the product

57

bullbull

middot Details of the product (name of manufacturer batch number expiry date) middot Nu m b er of units purchased sold a n d sto c k in ha nd middot Reason for recall middot Nam e of the supplier to whom produc ts w e r e returned along with the date and quantity middot Name and signature of the designated personnel carrying out the recall procedure and recording details middot Name and signature of the chief pharmacist verifying the recall procedures and recording details 4 4 Returned medicines

Medicines may be returned to the pharmacy by clients due to the following reasons -bull

bullbull Unused medicines bullbull Course not completed bullbull Therapy changed by doctor bullbull Side effects experienced by patient bull

bullbull DamagedDefective medicines bullbull Missing or defaced label bullbull Missing tablets in a stripblister bullbull Leakage in bottles bullbull Leakage in strips bull

bullbull Expired medicines

Appropriate SOPs should be framed and followed for their acceptancerefusal and disposal middot bull For unused medicines returned by clients the p harmacy personnel should verify

that these were purchased from their pharmacy They should then be checked for integrity of the packing the dosage form and the expiry date and verified with the client whether they were stored in appropriate conditions This again is at the discretion of each pharmacy

middot The damageddefective medicines returned to the pharmacy should be taken back and stored separately Existing stock of the same product should be checked for similar defects

middot Expired medicines should be accepted from clients at the discretion of the pharmacist and be immediately shifted to the expired goods cupboard These can be stored segregated from the pharmacys own expired goods and be appropriately labelled ldquoExpired Goods returned by clients- Not For Salerdquo

It is advisable not to accept returned medicines requiring cold chain storage (refrigeration) because it cannot be ensured that the cold chain was maintained when the medicines were in the hands of the patientclient middot Appropriate adjustments in t he stocks should be made for medicines

returnedexchanged to update the inventory middot The medicines should then be returned to the respective shelves middot A lsquoReturned Goodsrsquo register needs to be maintained to record all details of returned

medicines

R egister should include such details as-

58

middot N a m e o f t h e p a t i e n t middot Nam e of the product and quantity r e tu r n e d middot Product details such as the batch number and expiry date middot Condition in which received middot Reason for returning products middot Compensatory measures taken wi t h r e s p e c t t o c l i e n t middot Action taken with respect to product middot Name and signature of the personnel accepting the returned medicines and recording details middot Name and signature of the chief pharmacist verifying the recorded details

What the pharmacist would have learnt from this module The storage of medicines is a critical factor in the distribution cycle bullbull Stocks received by the pharmacy should be quarantined in a separate area and necessary checks s h o u ld be performed to ascertain the qua lity a nd quantity of stocks received bullbull Whatever pattern and means of storage used the products should be stored so as to maintain their potency and integrity bullbull Storage conditions should be monitored and maintained on a regular basis bullbull Optimum stock levels should be maintained and regularly monitored for expiry bullbull The design of storage areas should facilitate appropriate storage of medicines bullbull Cleanliness should be maintained in the pharmacy bullbull Adequate measures should be taken in case of returned medicines and recalled products

Optimum storage of medicines is mandatory whether at the distribution stage at the pharmacy or ultimately within the homes of patients The pharmacist has an important r o l e t o p l a y i n t h e s t o r a g e o f m e d i c i n e s i n m a i n t a i n i n g d r u g p o t ency and efficacy and thus facilitating optimum therapeutic benefits Good Pharmacy Practice - IPA -CDSCO - WHO Appendix I Quality Assurance Templates of letters for use if found not of Standard Quality [Frozen and expired goods ]

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated To Name of the Supplier with address

Sub Not of Standard Quality GoMP-Supply of Drugs and medicines-(Codename) Return of Stocks to the Suppliers-reg(New drug policy 2009) Previous letterinvoice ref Sl No Drug Code Drug name

Manufacturing date Expiry date

Supplier address

B a t c h n o

The above items of PO nodated was drawn by the Drug Inspector (Place) on (______________date) as a statutory sampling and declared ldquoNot of Standard

59

Qualityrdquo on -(______________date) by the Government Analyst for the following reasons

- ldquoThe product sample do not confirm to IP specification for (Drug codename with respect to the content of drugrdquo

- ldquoThe product has already been blacklisted by TNMSC on -(______________date) for the failure of (quantity) of batches of drug codenamerdquo

As per the clause of the te nde r d oc um e nt ldquo I f the sa mple s d o not c onf o r m to statutory standardsthe tenderer will be liable for relevant action under the existing laws and the entire stock in such batch should be taken back by the tenderer within a period of 30 days o f t h e r e c e i p t o f t h e l e t t e r f r o m t h e v e n u e

The stock shall be taken back at the expenses of the tendererthe Procurement Authority have the right to destroy such Not of Standard Quality if the tenderer does not take back the goods within the stipulated time

The Procuring Authority will arrange to destroy the Not of Standard Quality drugs within 90 days after the expiry of 30 days mentioned above without further notice and shall also collect demurrage charges calculated at the rate of 2 per week on the value of the drugs rejected till such destructionrdquo

Hence we regret to inform you that you will have to take back the stocks available of the abovesaid batch at your own cost from the drug stores where you have supplied the above batch

Kindly acknowledge the receipt of this reference at once

P r o c u r e m e n t A u t h o r i t y Seal and Stamp

Copy to Ref No dated

1 ) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated13082010

To

Sub Frozen Drugs-ordered to return to the Suppliers-reg(New drug policy 2009) Previous letterinvoice ref

The following products which were earlier frozen have now been ordered to return to suppliers directly with permission from the State drug Authority In this regard the suppliers have been instructed to take back their failed batch from the drug store of the stores Hence you are now instructed to return the following failed batches to the suppliers by obtaining proper authorization letter and acknowledgements from them

60

Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

Kindly acknowledge the receipt of this reference at once

Procurement Authority Seal and Stamp

Copy to

Ref No dated 2) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated14092010

To

Sub Frozen Drugs-ordered to return to the Suppliers- for issue of gate pass after verification reg(New drug policy 2009) Previous letterinvoice ref

The following products which were earlier frozen have now been released Hence they may be issued Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

Kindly acknowledge the receipt of this reference at once

Procurement Authority Seal and Stamp

Copy to

61

Ref No dated 3) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated

To

Sub Stop instruction-reg(New drug policy 2009) Previous letterinvoice ref

Until further instructions stop issue all the batches of the following item Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

You must intimate the available stock in the stores of the said batch Number to the Procurement Authority immediately Also retrieve quantity if already issued

Procurement Authority Seal and Stamp

Copy to

Ref No dated 4) HOD Procurement Office of

62

Appendix II Material handling in drug stores

Rack approx rates and dimensions

S No

Item Description UOM Approx Rate

1 MEDIUM DUTY RACK SIZE 2900 H X 3090 W X 800 D IN MM (AS PER SPECIFICATION)

Each 2499800

2 MEDIUM DUTY RACK ADD ON UNIT FOR SIZE OF SR NO2

Each 2243100

To locate a Box no 3 Rack no 14 in row3

SAMPLE OF RACK no Bin numbering -------------- S a y R K 1 4 R o w 3 B o x 1 6

SAMPLE LAYOUT of RACKS in a Drug Stores

63

Sample of another warehouse of distribution warehouse system

64

65

Slotted Angle racks with bin cards

66

Plastic Pallets

Plastic pallets ar e l i g h t w e i g h t l o w- c ost and exceed industry standards for strength and durability

NOTE A pallet has bottom deckboards (see sketch) A skid does not have bottom

67

deckboards

Battery Operated Stacker

Electric Stacker Ehh (Manual Push Type) - Manual drive - Lifting electrically with Battery 12 V 88 Ah - For loading and un-loading of trucks - Battery and loading device built - in - Battery charge gauge and charging current gauge Simple and Easy Operation - Lifting and Lowering electrically direct on steering arm - Pulling and pushing through steering arm - Electrically operated relief valve on hydraulic aggregate Safe Operation - Emergency Off Switch - Constant lowering speed - Protection through lowering brake valve - Overload protection through overload brake valve - Load chains covered preventing pinching threat - Electrically interlocking during loading process - Secured battery compartment opens upwardly - Stable buffering of the steering arm in upright position - In accordance with EWG Guidelines 89 240 - In accordance with VBG 12b Prevention of Accidents

Pallet Truck [ Top ]

68

----------------------------------------------------------------------------------------------------------------------------

For Transport Of All Goods On Pallets Safe and Easy Operation - through single hand operation Lifting moving

lowering with steering handle - neutral position of the hydraulic possible - overload pressure relief valve Long Service Life - robust co n s t r u c t i o n

- special hardened axles - hardened chromium plated ram - maintenance free Easy Maneuverability - through rubber steering rollers - nylon fork rollers

A h a n d t r o l l e y

69

Trolley with plastic bins for several items del ivery

70

Digital Weighing balances

Balances amp Scales EF Seriers Precision Electronic Balance

71

1

Ice lined Refrigerators

600 litres refrigrator

72

Walk in cooler

vacuum cleaner

73

While cleaning dust settled on dosage forms like bottles tubes etc should be removed Before dispensing the products should also be wiped to remove any dust settled during storage

For refrigerators bullbullDefrosting and cleaning should be done at regular intervals bullbullSwitch off the refrigerator while cleaning bullbullCleaning should be done quickly and stocks put back immediately

i i ) Pest control Pests are a serious problem in India where insects reptiles and rodents (eg cockroaches l i z a r d s r a t s s i l v e r f i s h (Deemak - in Hindi ) etc) may find access to the pharmacy storage areas Insects like ants and borer ants may often attack wood in the pharmacy causing d am ag e to shelves cupboardsPest c ontr o l in a p h a r m a c y c a n b e a d i f f i c u l t t a s k b u t t o avoid possible contamination and physical damage to stock it is necessary to keep pests out of the pharmacy premisesPest control measures should be implemented with proper p r e c a u t i o n s t a k i n g u t m o s t c a r e t o a v o i d contamination of medicines

55

Th e following pest control measures c a n be ta ke n f r om tim e to tim e -bullbullRat bait and traps can be placed at various locations bullbullInsecticutors can be used on a permanent basis bullbullInsecticidal sprays and repellants can be used from time to time

i i i ) Fire precautions

Combustible trash such as cartons boxes and other packing waste must not be allowed to accumulate in the store Waste should be deposited in appropriate waste bins and be d i s p o s e d o f f o n a d a i l y b a s i s

F i re detection and fire fighting equipment must be maintained and regularly inspected The pharmacy personnel should receive adequate training in fire fighting techniques and emergency actionFire prevention measures should include a prominently displayed ldquoNoSmokingrdquo sign careful handling and disposal of combustible waste materials and checking of electrical connections at regular intervals

iv) Security middot Doors shutters of the pharmacy should be strong and be fitted with secure locks middot Counters should be designed so that unauthorized personnelclients do not have

access to areas where prescription medicines are stored Access to such areas should be restricted to the pharmacy staff

middot All the pharmacy staff handling supplies should be accountable for their ac t i o n s

56

middot bullSpecial care must be taken in case of Schedule X and manufactured drugs (under NDPS Act) Such medicines should be kept under lock and key and the key should be kept with the Chief Pharmacist or i n h i s a b s e n c e t h e s e n i o r p h a r m a c i s t

v) Breakagespillage and damaged product Products that have been damagedspoiled during storage and handling spillages and broken glassware should be disposed off according to procedures laid down by the pharmacy Broken and damaged products s h o u l d b e p l a c e d i n a segregated area to be returned to the supplier

vi) Inspection Senior staff should inspect all pharmacy areas regularly The shelves and drawers should b e c h e c k e d d a i l y f o r signs of pests and dust Ceiling and walls should be checked for dirt and cobwebs Stock should be checked on a regular basis for deterioration due to climatic conditions

43 Product recalls Products found to be defective should be quickly recalled (withdrawn from the market) The instructions are generally issued either by the manufacturer or the regulatory agency The level of recall is determined by both the degree of risk and the extent of distribution of the product and in India is mainly directed at the distribution chain

On receiving the details of the defective substandard spurious batchbatches of a medicine to be recalled from the manufacturer or the stockist or the FDA the pharmacy should immediately check if the particular b a t c h i s i n s t o c k a n d i f s o s u s p e n d i t s s a l e immediately

Similarly if the regulatory authority in the country bans a particular medicine or FDC the pharmacy should immediately check and remove all the different brands of that particular medicine under consideration

The details of medicines and their batches to be recalled should be available in the q u a r a n t i n e a r e a w h e r e stocks are received and checked This is to ensure that such medicines do not come into the pharmacy

middot The pharmacy should develop SOPs for recall of medicines middot The pharmacy staff should be immediately informed about such medicines and

the details should be displayed in writing in a prominent place in the pharmacy middot Rapid action helps avoid unnecessary exposure to such medicines once the

problem has been d e t e c t e d middot The progress of the recall procedure in the pharmacy should be monitored every

few days to ensure complete compliance middot All stocks of the recalled products should be stored separately from the saleable

stock These can be stored in the expiry cupboard segregated from the expired goods and be appropriately labeled ldquoRecal l e d G o o d s - Not for Salerdquo

The supplier should be notified and asked to replace defective products middot All the details of the procedures followed should be duly recorded in a Recall

Register maintained specially for the purpose The register should include d etails such as -middot Date of the recall middot Nam e of the product

57

bullbull

middot Details of the product (name of manufacturer batch number expiry date) middot Nu m b er of units purchased sold a n d sto c k in ha nd middot Reason for recall middot Nam e of the supplier to whom produc ts w e r e returned along with the date and quantity middot Name and signature of the designated personnel carrying out the recall procedure and recording details middot Name and signature of the chief pharmacist verifying the recall procedures and recording details 4 4 Returned medicines

Medicines may be returned to the pharmacy by clients due to the following reasons -bull

bullbull Unused medicines bullbull Course not completed bullbull Therapy changed by doctor bullbull Side effects experienced by patient bull

bullbull DamagedDefective medicines bullbull Missing or defaced label bullbull Missing tablets in a stripblister bullbull Leakage in bottles bullbull Leakage in strips bull

bullbull Expired medicines

Appropriate SOPs should be framed and followed for their acceptancerefusal and disposal middot bull For unused medicines returned by clients the p harmacy personnel should verify

that these were purchased from their pharmacy They should then be checked for integrity of the packing the dosage form and the expiry date and verified with the client whether they were stored in appropriate conditions This again is at the discretion of each pharmacy

middot The damageddefective medicines returned to the pharmacy should be taken back and stored separately Existing stock of the same product should be checked for similar defects

middot Expired medicines should be accepted from clients at the discretion of the pharmacist and be immediately shifted to the expired goods cupboard These can be stored segregated from the pharmacys own expired goods and be appropriately labelled ldquoExpired Goods returned by clients- Not For Salerdquo

It is advisable not to accept returned medicines requiring cold chain storage (refrigeration) because it cannot be ensured that the cold chain was maintained when the medicines were in the hands of the patientclient middot Appropriate adjustments in t he stocks should be made for medicines

returnedexchanged to update the inventory middot The medicines should then be returned to the respective shelves middot A lsquoReturned Goodsrsquo register needs to be maintained to record all details of returned

medicines

R egister should include such details as-

58

middot N a m e o f t h e p a t i e n t middot Nam e of the product and quantity r e tu r n e d middot Product details such as the batch number and expiry date middot Condition in which received middot Reason for returning products middot Compensatory measures taken wi t h r e s p e c t t o c l i e n t middot Action taken with respect to product middot Name and signature of the personnel accepting the returned medicines and recording details middot Name and signature of the chief pharmacist verifying the recorded details

What the pharmacist would have learnt from this module The storage of medicines is a critical factor in the distribution cycle bullbull Stocks received by the pharmacy should be quarantined in a separate area and necessary checks s h o u ld be performed to ascertain the qua lity a nd quantity of stocks received bullbull Whatever pattern and means of storage used the products should be stored so as to maintain their potency and integrity bullbull Storage conditions should be monitored and maintained on a regular basis bullbull Optimum stock levels should be maintained and regularly monitored for expiry bullbull The design of storage areas should facilitate appropriate storage of medicines bullbull Cleanliness should be maintained in the pharmacy bullbull Adequate measures should be taken in case of returned medicines and recalled products

Optimum storage of medicines is mandatory whether at the distribution stage at the pharmacy or ultimately within the homes of patients The pharmacist has an important r o l e t o p l a y i n t h e s t o r a g e o f m e d i c i n e s i n m a i n t a i n i n g d r u g p o t ency and efficacy and thus facilitating optimum therapeutic benefits Good Pharmacy Practice - IPA -CDSCO - WHO Appendix I Quality Assurance Templates of letters for use if found not of Standard Quality [Frozen and expired goods ]

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated To Name of the Supplier with address

Sub Not of Standard Quality GoMP-Supply of Drugs and medicines-(Codename) Return of Stocks to the Suppliers-reg(New drug policy 2009) Previous letterinvoice ref Sl No Drug Code Drug name

Manufacturing date Expiry date

Supplier address

B a t c h n o

The above items of PO nodated was drawn by the Drug Inspector (Place) on (______________date) as a statutory sampling and declared ldquoNot of Standard

59

Qualityrdquo on -(______________date) by the Government Analyst for the following reasons

- ldquoThe product sample do not confirm to IP specification for (Drug codename with respect to the content of drugrdquo

- ldquoThe product has already been blacklisted by TNMSC on -(______________date) for the failure of (quantity) of batches of drug codenamerdquo

As per the clause of the te nde r d oc um e nt ldquo I f the sa mple s d o not c onf o r m to statutory standardsthe tenderer will be liable for relevant action under the existing laws and the entire stock in such batch should be taken back by the tenderer within a period of 30 days o f t h e r e c e i p t o f t h e l e t t e r f r o m t h e v e n u e

The stock shall be taken back at the expenses of the tendererthe Procurement Authority have the right to destroy such Not of Standard Quality if the tenderer does not take back the goods within the stipulated time

The Procuring Authority will arrange to destroy the Not of Standard Quality drugs within 90 days after the expiry of 30 days mentioned above without further notice and shall also collect demurrage charges calculated at the rate of 2 per week on the value of the drugs rejected till such destructionrdquo

Hence we regret to inform you that you will have to take back the stocks available of the abovesaid batch at your own cost from the drug stores where you have supplied the above batch

Kindly acknowledge the receipt of this reference at once

P r o c u r e m e n t A u t h o r i t y Seal and Stamp

Copy to Ref No dated

1 ) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated13082010

To

Sub Frozen Drugs-ordered to return to the Suppliers-reg(New drug policy 2009) Previous letterinvoice ref

The following products which were earlier frozen have now been ordered to return to suppliers directly with permission from the State drug Authority In this regard the suppliers have been instructed to take back their failed batch from the drug store of the stores Hence you are now instructed to return the following failed batches to the suppliers by obtaining proper authorization letter and acknowledgements from them

60

Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

Kindly acknowledge the receipt of this reference at once

Procurement Authority Seal and Stamp

Copy to

Ref No dated 2) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated14092010

To

Sub Frozen Drugs-ordered to return to the Suppliers- for issue of gate pass after verification reg(New drug policy 2009) Previous letterinvoice ref

The following products which were earlier frozen have now been released Hence they may be issued Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

Kindly acknowledge the receipt of this reference at once

Procurement Authority Seal and Stamp

Copy to

61

Ref No dated 3) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated

To

Sub Stop instruction-reg(New drug policy 2009) Previous letterinvoice ref

Until further instructions stop issue all the batches of the following item Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

You must intimate the available stock in the stores of the said batch Number to the Procurement Authority immediately Also retrieve quantity if already issued

Procurement Authority Seal and Stamp

Copy to

Ref No dated 4) HOD Procurement Office of

62

Appendix II Material handling in drug stores

Rack approx rates and dimensions

S No

Item Description UOM Approx Rate

1 MEDIUM DUTY RACK SIZE 2900 H X 3090 W X 800 D IN MM (AS PER SPECIFICATION)

Each 2499800

2 MEDIUM DUTY RACK ADD ON UNIT FOR SIZE OF SR NO2

Each 2243100

To locate a Box no 3 Rack no 14 in row3

SAMPLE OF RACK no Bin numbering -------------- S a y R K 1 4 R o w 3 B o x 1 6

SAMPLE LAYOUT of RACKS in a Drug Stores

63

Sample of another warehouse of distribution warehouse system

64

65

Slotted Angle racks with bin cards

66

Plastic Pallets

Plastic pallets ar e l i g h t w e i g h t l o w- c ost and exceed industry standards for strength and durability

NOTE A pallet has bottom deckboards (see sketch) A skid does not have bottom

67

deckboards

Battery Operated Stacker

Electric Stacker Ehh (Manual Push Type) - Manual drive - Lifting electrically with Battery 12 V 88 Ah - For loading and un-loading of trucks - Battery and loading device built - in - Battery charge gauge and charging current gauge Simple and Easy Operation - Lifting and Lowering electrically direct on steering arm - Pulling and pushing through steering arm - Electrically operated relief valve on hydraulic aggregate Safe Operation - Emergency Off Switch - Constant lowering speed - Protection through lowering brake valve - Overload protection through overload brake valve - Load chains covered preventing pinching threat - Electrically interlocking during loading process - Secured battery compartment opens upwardly - Stable buffering of the steering arm in upright position - In accordance with EWG Guidelines 89 240 - In accordance with VBG 12b Prevention of Accidents

Pallet Truck [ Top ]

68

----------------------------------------------------------------------------------------------------------------------------

For Transport Of All Goods On Pallets Safe and Easy Operation - through single hand operation Lifting moving

lowering with steering handle - neutral position of the hydraulic possible - overload pressure relief valve Long Service Life - robust co n s t r u c t i o n

- special hardened axles - hardened chromium plated ram - maintenance free Easy Maneuverability - through rubber steering rollers - nylon fork rollers

A h a n d t r o l l e y

69

Trolley with plastic bins for several items del ivery

70

Digital Weighing balances

Balances amp Scales EF Seriers Precision Electronic Balance

71

1

Ice lined Refrigerators

600 litres refrigrator

72

Walk in cooler

vacuum cleaner

73

Th e following pest control measures c a n be ta ke n f r om tim e to tim e -bullbullRat bait and traps can be placed at various locations bullbullInsecticutors can be used on a permanent basis bullbullInsecticidal sprays and repellants can be used from time to time

i i i ) Fire precautions

Combustible trash such as cartons boxes and other packing waste must not be allowed to accumulate in the store Waste should be deposited in appropriate waste bins and be d i s p o s e d o f f o n a d a i l y b a s i s

F i re detection and fire fighting equipment must be maintained and regularly inspected The pharmacy personnel should receive adequate training in fire fighting techniques and emergency actionFire prevention measures should include a prominently displayed ldquoNoSmokingrdquo sign careful handling and disposal of combustible waste materials and checking of electrical connections at regular intervals

iv) Security middot Doors shutters of the pharmacy should be strong and be fitted with secure locks middot Counters should be designed so that unauthorized personnelclients do not have

access to areas where prescription medicines are stored Access to such areas should be restricted to the pharmacy staff

middot All the pharmacy staff handling supplies should be accountable for their ac t i o n s

56

middot bullSpecial care must be taken in case of Schedule X and manufactured drugs (under NDPS Act) Such medicines should be kept under lock and key and the key should be kept with the Chief Pharmacist or i n h i s a b s e n c e t h e s e n i o r p h a r m a c i s t

v) Breakagespillage and damaged product Products that have been damagedspoiled during storage and handling spillages and broken glassware should be disposed off according to procedures laid down by the pharmacy Broken and damaged products s h o u l d b e p l a c e d i n a segregated area to be returned to the supplier

vi) Inspection Senior staff should inspect all pharmacy areas regularly The shelves and drawers should b e c h e c k e d d a i l y f o r signs of pests and dust Ceiling and walls should be checked for dirt and cobwebs Stock should be checked on a regular basis for deterioration due to climatic conditions

43 Product recalls Products found to be defective should be quickly recalled (withdrawn from the market) The instructions are generally issued either by the manufacturer or the regulatory agency The level of recall is determined by both the degree of risk and the extent of distribution of the product and in India is mainly directed at the distribution chain

On receiving the details of the defective substandard spurious batchbatches of a medicine to be recalled from the manufacturer or the stockist or the FDA the pharmacy should immediately check if the particular b a t c h i s i n s t o c k a n d i f s o s u s p e n d i t s s a l e immediately

Similarly if the regulatory authority in the country bans a particular medicine or FDC the pharmacy should immediately check and remove all the different brands of that particular medicine under consideration

The details of medicines and their batches to be recalled should be available in the q u a r a n t i n e a r e a w h e r e stocks are received and checked This is to ensure that such medicines do not come into the pharmacy

middot The pharmacy should develop SOPs for recall of medicines middot The pharmacy staff should be immediately informed about such medicines and

the details should be displayed in writing in a prominent place in the pharmacy middot Rapid action helps avoid unnecessary exposure to such medicines once the

problem has been d e t e c t e d middot The progress of the recall procedure in the pharmacy should be monitored every

few days to ensure complete compliance middot All stocks of the recalled products should be stored separately from the saleable

stock These can be stored in the expiry cupboard segregated from the expired goods and be appropriately labeled ldquoRecal l e d G o o d s - Not for Salerdquo

The supplier should be notified and asked to replace defective products middot All the details of the procedures followed should be duly recorded in a Recall

Register maintained specially for the purpose The register should include d etails such as -middot Date of the recall middot Nam e of the product

57

bullbull

middot Details of the product (name of manufacturer batch number expiry date) middot Nu m b er of units purchased sold a n d sto c k in ha nd middot Reason for recall middot Nam e of the supplier to whom produc ts w e r e returned along with the date and quantity middot Name and signature of the designated personnel carrying out the recall procedure and recording details middot Name and signature of the chief pharmacist verifying the recall procedures and recording details 4 4 Returned medicines

Medicines may be returned to the pharmacy by clients due to the following reasons -bull

bullbull Unused medicines bullbull Course not completed bullbull Therapy changed by doctor bullbull Side effects experienced by patient bull

bullbull DamagedDefective medicines bullbull Missing or defaced label bullbull Missing tablets in a stripblister bullbull Leakage in bottles bullbull Leakage in strips bull

bullbull Expired medicines

Appropriate SOPs should be framed and followed for their acceptancerefusal and disposal middot bull For unused medicines returned by clients the p harmacy personnel should verify

that these were purchased from their pharmacy They should then be checked for integrity of the packing the dosage form and the expiry date and verified with the client whether they were stored in appropriate conditions This again is at the discretion of each pharmacy

middot The damageddefective medicines returned to the pharmacy should be taken back and stored separately Existing stock of the same product should be checked for similar defects

middot Expired medicines should be accepted from clients at the discretion of the pharmacist and be immediately shifted to the expired goods cupboard These can be stored segregated from the pharmacys own expired goods and be appropriately labelled ldquoExpired Goods returned by clients- Not For Salerdquo

It is advisable not to accept returned medicines requiring cold chain storage (refrigeration) because it cannot be ensured that the cold chain was maintained when the medicines were in the hands of the patientclient middot Appropriate adjustments in t he stocks should be made for medicines

returnedexchanged to update the inventory middot The medicines should then be returned to the respective shelves middot A lsquoReturned Goodsrsquo register needs to be maintained to record all details of returned

medicines

R egister should include such details as-

58

middot N a m e o f t h e p a t i e n t middot Nam e of the product and quantity r e tu r n e d middot Product details such as the batch number and expiry date middot Condition in which received middot Reason for returning products middot Compensatory measures taken wi t h r e s p e c t t o c l i e n t middot Action taken with respect to product middot Name and signature of the personnel accepting the returned medicines and recording details middot Name and signature of the chief pharmacist verifying the recorded details

What the pharmacist would have learnt from this module The storage of medicines is a critical factor in the distribution cycle bullbull Stocks received by the pharmacy should be quarantined in a separate area and necessary checks s h o u ld be performed to ascertain the qua lity a nd quantity of stocks received bullbull Whatever pattern and means of storage used the products should be stored so as to maintain their potency and integrity bullbull Storage conditions should be monitored and maintained on a regular basis bullbull Optimum stock levels should be maintained and regularly monitored for expiry bullbull The design of storage areas should facilitate appropriate storage of medicines bullbull Cleanliness should be maintained in the pharmacy bullbull Adequate measures should be taken in case of returned medicines and recalled products

Optimum storage of medicines is mandatory whether at the distribution stage at the pharmacy or ultimately within the homes of patients The pharmacist has an important r o l e t o p l a y i n t h e s t o r a g e o f m e d i c i n e s i n m a i n t a i n i n g d r u g p o t ency and efficacy and thus facilitating optimum therapeutic benefits Good Pharmacy Practice - IPA -CDSCO - WHO Appendix I Quality Assurance Templates of letters for use if found not of Standard Quality [Frozen and expired goods ]

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated To Name of the Supplier with address

Sub Not of Standard Quality GoMP-Supply of Drugs and medicines-(Codename) Return of Stocks to the Suppliers-reg(New drug policy 2009) Previous letterinvoice ref Sl No Drug Code Drug name

Manufacturing date Expiry date

Supplier address

B a t c h n o

The above items of PO nodated was drawn by the Drug Inspector (Place) on (______________date) as a statutory sampling and declared ldquoNot of Standard

59

Qualityrdquo on -(______________date) by the Government Analyst for the following reasons

- ldquoThe product sample do not confirm to IP specification for (Drug codename with respect to the content of drugrdquo

- ldquoThe product has already been blacklisted by TNMSC on -(______________date) for the failure of (quantity) of batches of drug codenamerdquo

As per the clause of the te nde r d oc um e nt ldquo I f the sa mple s d o not c onf o r m to statutory standardsthe tenderer will be liable for relevant action under the existing laws and the entire stock in such batch should be taken back by the tenderer within a period of 30 days o f t h e r e c e i p t o f t h e l e t t e r f r o m t h e v e n u e

The stock shall be taken back at the expenses of the tendererthe Procurement Authority have the right to destroy such Not of Standard Quality if the tenderer does not take back the goods within the stipulated time

The Procuring Authority will arrange to destroy the Not of Standard Quality drugs within 90 days after the expiry of 30 days mentioned above without further notice and shall also collect demurrage charges calculated at the rate of 2 per week on the value of the drugs rejected till such destructionrdquo

Hence we regret to inform you that you will have to take back the stocks available of the abovesaid batch at your own cost from the drug stores where you have supplied the above batch

Kindly acknowledge the receipt of this reference at once

P r o c u r e m e n t A u t h o r i t y Seal and Stamp

Copy to Ref No dated

1 ) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated13082010

To

Sub Frozen Drugs-ordered to return to the Suppliers-reg(New drug policy 2009) Previous letterinvoice ref

The following products which were earlier frozen have now been ordered to return to suppliers directly with permission from the State drug Authority In this regard the suppliers have been instructed to take back their failed batch from the drug store of the stores Hence you are now instructed to return the following failed batches to the suppliers by obtaining proper authorization letter and acknowledgements from them

60

Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

Kindly acknowledge the receipt of this reference at once

Procurement Authority Seal and Stamp

Copy to

Ref No dated 2) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated14092010

To

Sub Frozen Drugs-ordered to return to the Suppliers- for issue of gate pass after verification reg(New drug policy 2009) Previous letterinvoice ref

The following products which were earlier frozen have now been released Hence they may be issued Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

Kindly acknowledge the receipt of this reference at once

Procurement Authority Seal and Stamp

Copy to

61

Ref No dated 3) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated

To

Sub Stop instruction-reg(New drug policy 2009) Previous letterinvoice ref

Until further instructions stop issue all the batches of the following item Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

You must intimate the available stock in the stores of the said batch Number to the Procurement Authority immediately Also retrieve quantity if already issued

Procurement Authority Seal and Stamp

Copy to

Ref No dated 4) HOD Procurement Office of

62

Appendix II Material handling in drug stores

Rack approx rates and dimensions

S No

Item Description UOM Approx Rate

1 MEDIUM DUTY RACK SIZE 2900 H X 3090 W X 800 D IN MM (AS PER SPECIFICATION)

Each 2499800

2 MEDIUM DUTY RACK ADD ON UNIT FOR SIZE OF SR NO2

Each 2243100

To locate a Box no 3 Rack no 14 in row3

SAMPLE OF RACK no Bin numbering -------------- S a y R K 1 4 R o w 3 B o x 1 6

SAMPLE LAYOUT of RACKS in a Drug Stores

63

Sample of another warehouse of distribution warehouse system

64

65

Slotted Angle racks with bin cards

66

Plastic Pallets

Plastic pallets ar e l i g h t w e i g h t l o w- c ost and exceed industry standards for strength and durability

NOTE A pallet has bottom deckboards (see sketch) A skid does not have bottom

67

deckboards

Battery Operated Stacker

Electric Stacker Ehh (Manual Push Type) - Manual drive - Lifting electrically with Battery 12 V 88 Ah - For loading and un-loading of trucks - Battery and loading device built - in - Battery charge gauge and charging current gauge Simple and Easy Operation - Lifting and Lowering electrically direct on steering arm - Pulling and pushing through steering arm - Electrically operated relief valve on hydraulic aggregate Safe Operation - Emergency Off Switch - Constant lowering speed - Protection through lowering brake valve - Overload protection through overload brake valve - Load chains covered preventing pinching threat - Electrically interlocking during loading process - Secured battery compartment opens upwardly - Stable buffering of the steering arm in upright position - In accordance with EWG Guidelines 89 240 - In accordance with VBG 12b Prevention of Accidents

Pallet Truck [ Top ]

68

----------------------------------------------------------------------------------------------------------------------------

For Transport Of All Goods On Pallets Safe and Easy Operation - through single hand operation Lifting moving

lowering with steering handle - neutral position of the hydraulic possible - overload pressure relief valve Long Service Life - robust co n s t r u c t i o n

- special hardened axles - hardened chromium plated ram - maintenance free Easy Maneuverability - through rubber steering rollers - nylon fork rollers

A h a n d t r o l l e y

69

Trolley with plastic bins for several items del ivery

70

Digital Weighing balances

Balances amp Scales EF Seriers Precision Electronic Balance

71

1

Ice lined Refrigerators

600 litres refrigrator

72

Walk in cooler

vacuum cleaner

73

middot bullSpecial care must be taken in case of Schedule X and manufactured drugs (under NDPS Act) Such medicines should be kept under lock and key and the key should be kept with the Chief Pharmacist or i n h i s a b s e n c e t h e s e n i o r p h a r m a c i s t

v) Breakagespillage and damaged product Products that have been damagedspoiled during storage and handling spillages and broken glassware should be disposed off according to procedures laid down by the pharmacy Broken and damaged products s h o u l d b e p l a c e d i n a segregated area to be returned to the supplier

vi) Inspection Senior staff should inspect all pharmacy areas regularly The shelves and drawers should b e c h e c k e d d a i l y f o r signs of pests and dust Ceiling and walls should be checked for dirt and cobwebs Stock should be checked on a regular basis for deterioration due to climatic conditions

43 Product recalls Products found to be defective should be quickly recalled (withdrawn from the market) The instructions are generally issued either by the manufacturer or the regulatory agency The level of recall is determined by both the degree of risk and the extent of distribution of the product and in India is mainly directed at the distribution chain

On receiving the details of the defective substandard spurious batchbatches of a medicine to be recalled from the manufacturer or the stockist or the FDA the pharmacy should immediately check if the particular b a t c h i s i n s t o c k a n d i f s o s u s p e n d i t s s a l e immediately

Similarly if the regulatory authority in the country bans a particular medicine or FDC the pharmacy should immediately check and remove all the different brands of that particular medicine under consideration

The details of medicines and their batches to be recalled should be available in the q u a r a n t i n e a r e a w h e r e stocks are received and checked This is to ensure that such medicines do not come into the pharmacy

middot The pharmacy should develop SOPs for recall of medicines middot The pharmacy staff should be immediately informed about such medicines and

the details should be displayed in writing in a prominent place in the pharmacy middot Rapid action helps avoid unnecessary exposure to such medicines once the

problem has been d e t e c t e d middot The progress of the recall procedure in the pharmacy should be monitored every

few days to ensure complete compliance middot All stocks of the recalled products should be stored separately from the saleable

stock These can be stored in the expiry cupboard segregated from the expired goods and be appropriately labeled ldquoRecal l e d G o o d s - Not for Salerdquo

The supplier should be notified and asked to replace defective products middot All the details of the procedures followed should be duly recorded in a Recall

Register maintained specially for the purpose The register should include d etails such as -middot Date of the recall middot Nam e of the product

57

bullbull

middot Details of the product (name of manufacturer batch number expiry date) middot Nu m b er of units purchased sold a n d sto c k in ha nd middot Reason for recall middot Nam e of the supplier to whom produc ts w e r e returned along with the date and quantity middot Name and signature of the designated personnel carrying out the recall procedure and recording details middot Name and signature of the chief pharmacist verifying the recall procedures and recording details 4 4 Returned medicines

Medicines may be returned to the pharmacy by clients due to the following reasons -bull

bullbull Unused medicines bullbull Course not completed bullbull Therapy changed by doctor bullbull Side effects experienced by patient bull

bullbull DamagedDefective medicines bullbull Missing or defaced label bullbull Missing tablets in a stripblister bullbull Leakage in bottles bullbull Leakage in strips bull

bullbull Expired medicines

Appropriate SOPs should be framed and followed for their acceptancerefusal and disposal middot bull For unused medicines returned by clients the p harmacy personnel should verify

that these were purchased from their pharmacy They should then be checked for integrity of the packing the dosage form and the expiry date and verified with the client whether they were stored in appropriate conditions This again is at the discretion of each pharmacy

middot The damageddefective medicines returned to the pharmacy should be taken back and stored separately Existing stock of the same product should be checked for similar defects

middot Expired medicines should be accepted from clients at the discretion of the pharmacist and be immediately shifted to the expired goods cupboard These can be stored segregated from the pharmacys own expired goods and be appropriately labelled ldquoExpired Goods returned by clients- Not For Salerdquo

It is advisable not to accept returned medicines requiring cold chain storage (refrigeration) because it cannot be ensured that the cold chain was maintained when the medicines were in the hands of the patientclient middot Appropriate adjustments in t he stocks should be made for medicines

returnedexchanged to update the inventory middot The medicines should then be returned to the respective shelves middot A lsquoReturned Goodsrsquo register needs to be maintained to record all details of returned

medicines

R egister should include such details as-

58

middot N a m e o f t h e p a t i e n t middot Nam e of the product and quantity r e tu r n e d middot Product details such as the batch number and expiry date middot Condition in which received middot Reason for returning products middot Compensatory measures taken wi t h r e s p e c t t o c l i e n t middot Action taken with respect to product middot Name and signature of the personnel accepting the returned medicines and recording details middot Name and signature of the chief pharmacist verifying the recorded details

What the pharmacist would have learnt from this module The storage of medicines is a critical factor in the distribution cycle bullbull Stocks received by the pharmacy should be quarantined in a separate area and necessary checks s h o u ld be performed to ascertain the qua lity a nd quantity of stocks received bullbull Whatever pattern and means of storage used the products should be stored so as to maintain their potency and integrity bullbull Storage conditions should be monitored and maintained on a regular basis bullbull Optimum stock levels should be maintained and regularly monitored for expiry bullbull The design of storage areas should facilitate appropriate storage of medicines bullbull Cleanliness should be maintained in the pharmacy bullbull Adequate measures should be taken in case of returned medicines and recalled products

Optimum storage of medicines is mandatory whether at the distribution stage at the pharmacy or ultimately within the homes of patients The pharmacist has an important r o l e t o p l a y i n t h e s t o r a g e o f m e d i c i n e s i n m a i n t a i n i n g d r u g p o t ency and efficacy and thus facilitating optimum therapeutic benefits Good Pharmacy Practice - IPA -CDSCO - WHO Appendix I Quality Assurance Templates of letters for use if found not of Standard Quality [Frozen and expired goods ]

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated To Name of the Supplier with address

Sub Not of Standard Quality GoMP-Supply of Drugs and medicines-(Codename) Return of Stocks to the Suppliers-reg(New drug policy 2009) Previous letterinvoice ref Sl No Drug Code Drug name

Manufacturing date Expiry date

Supplier address

B a t c h n o

The above items of PO nodated was drawn by the Drug Inspector (Place) on (______________date) as a statutory sampling and declared ldquoNot of Standard

59

Qualityrdquo on -(______________date) by the Government Analyst for the following reasons

- ldquoThe product sample do not confirm to IP specification for (Drug codename with respect to the content of drugrdquo

- ldquoThe product has already been blacklisted by TNMSC on -(______________date) for the failure of (quantity) of batches of drug codenamerdquo

As per the clause of the te nde r d oc um e nt ldquo I f the sa mple s d o not c onf o r m to statutory standardsthe tenderer will be liable for relevant action under the existing laws and the entire stock in such batch should be taken back by the tenderer within a period of 30 days o f t h e r e c e i p t o f t h e l e t t e r f r o m t h e v e n u e

The stock shall be taken back at the expenses of the tendererthe Procurement Authority have the right to destroy such Not of Standard Quality if the tenderer does not take back the goods within the stipulated time

The Procuring Authority will arrange to destroy the Not of Standard Quality drugs within 90 days after the expiry of 30 days mentioned above without further notice and shall also collect demurrage charges calculated at the rate of 2 per week on the value of the drugs rejected till such destructionrdquo

Hence we regret to inform you that you will have to take back the stocks available of the abovesaid batch at your own cost from the drug stores where you have supplied the above batch

Kindly acknowledge the receipt of this reference at once

P r o c u r e m e n t A u t h o r i t y Seal and Stamp

Copy to Ref No dated

1 ) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated13082010

To

Sub Frozen Drugs-ordered to return to the Suppliers-reg(New drug policy 2009) Previous letterinvoice ref

The following products which were earlier frozen have now been ordered to return to suppliers directly with permission from the State drug Authority In this regard the suppliers have been instructed to take back their failed batch from the drug store of the stores Hence you are now instructed to return the following failed batches to the suppliers by obtaining proper authorization letter and acknowledgements from them

60

Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

Kindly acknowledge the receipt of this reference at once

Procurement Authority Seal and Stamp

Copy to

Ref No dated 2) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated14092010

To

Sub Frozen Drugs-ordered to return to the Suppliers- for issue of gate pass after verification reg(New drug policy 2009) Previous letterinvoice ref

The following products which were earlier frozen have now been released Hence they may be issued Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

Kindly acknowledge the receipt of this reference at once

Procurement Authority Seal and Stamp

Copy to

61

Ref No dated 3) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated

To

Sub Stop instruction-reg(New drug policy 2009) Previous letterinvoice ref

Until further instructions stop issue all the batches of the following item Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

You must intimate the available stock in the stores of the said batch Number to the Procurement Authority immediately Also retrieve quantity if already issued

Procurement Authority Seal and Stamp

Copy to

Ref No dated 4) HOD Procurement Office of

62

Appendix II Material handling in drug stores

Rack approx rates and dimensions

S No

Item Description UOM Approx Rate

1 MEDIUM DUTY RACK SIZE 2900 H X 3090 W X 800 D IN MM (AS PER SPECIFICATION)

Each 2499800

2 MEDIUM DUTY RACK ADD ON UNIT FOR SIZE OF SR NO2

Each 2243100

To locate a Box no 3 Rack no 14 in row3

SAMPLE OF RACK no Bin numbering -------------- S a y R K 1 4 R o w 3 B o x 1 6

SAMPLE LAYOUT of RACKS in a Drug Stores

63

Sample of another warehouse of distribution warehouse system

64

65

Slotted Angle racks with bin cards

66

Plastic Pallets

Plastic pallets ar e l i g h t w e i g h t l o w- c ost and exceed industry standards for strength and durability

NOTE A pallet has bottom deckboards (see sketch) A skid does not have bottom

67

deckboards

Battery Operated Stacker

Electric Stacker Ehh (Manual Push Type) - Manual drive - Lifting electrically with Battery 12 V 88 Ah - For loading and un-loading of trucks - Battery and loading device built - in - Battery charge gauge and charging current gauge Simple and Easy Operation - Lifting and Lowering electrically direct on steering arm - Pulling and pushing through steering arm - Electrically operated relief valve on hydraulic aggregate Safe Operation - Emergency Off Switch - Constant lowering speed - Protection through lowering brake valve - Overload protection through overload brake valve - Load chains covered preventing pinching threat - Electrically interlocking during loading process - Secured battery compartment opens upwardly - Stable buffering of the steering arm in upright position - In accordance with EWG Guidelines 89 240 - In accordance with VBG 12b Prevention of Accidents

Pallet Truck [ Top ]

68

----------------------------------------------------------------------------------------------------------------------------

For Transport Of All Goods On Pallets Safe and Easy Operation - through single hand operation Lifting moving

lowering with steering handle - neutral position of the hydraulic possible - overload pressure relief valve Long Service Life - robust co n s t r u c t i o n

- special hardened axles - hardened chromium plated ram - maintenance free Easy Maneuverability - through rubber steering rollers - nylon fork rollers

A h a n d t r o l l e y

69

Trolley with plastic bins for several items del ivery

70

Digital Weighing balances

Balances amp Scales EF Seriers Precision Electronic Balance

71

1

Ice lined Refrigerators

600 litres refrigrator

72

Walk in cooler

vacuum cleaner

73

bullbull

middot Details of the product (name of manufacturer batch number expiry date) middot Nu m b er of units purchased sold a n d sto c k in ha nd middot Reason for recall middot Nam e of the supplier to whom produc ts w e r e returned along with the date and quantity middot Name and signature of the designated personnel carrying out the recall procedure and recording details middot Name and signature of the chief pharmacist verifying the recall procedures and recording details 4 4 Returned medicines

Medicines may be returned to the pharmacy by clients due to the following reasons -bull

bullbull Unused medicines bullbull Course not completed bullbull Therapy changed by doctor bullbull Side effects experienced by patient bull

bullbull DamagedDefective medicines bullbull Missing or defaced label bullbull Missing tablets in a stripblister bullbull Leakage in bottles bullbull Leakage in strips bull

bullbull Expired medicines

Appropriate SOPs should be framed and followed for their acceptancerefusal and disposal middot bull For unused medicines returned by clients the p harmacy personnel should verify

that these were purchased from their pharmacy They should then be checked for integrity of the packing the dosage form and the expiry date and verified with the client whether they were stored in appropriate conditions This again is at the discretion of each pharmacy

middot The damageddefective medicines returned to the pharmacy should be taken back and stored separately Existing stock of the same product should be checked for similar defects

middot Expired medicines should be accepted from clients at the discretion of the pharmacist and be immediately shifted to the expired goods cupboard These can be stored segregated from the pharmacys own expired goods and be appropriately labelled ldquoExpired Goods returned by clients- Not For Salerdquo

It is advisable not to accept returned medicines requiring cold chain storage (refrigeration) because it cannot be ensured that the cold chain was maintained when the medicines were in the hands of the patientclient middot Appropriate adjustments in t he stocks should be made for medicines

returnedexchanged to update the inventory middot The medicines should then be returned to the respective shelves middot A lsquoReturned Goodsrsquo register needs to be maintained to record all details of returned

medicines

R egister should include such details as-

58

middot N a m e o f t h e p a t i e n t middot Nam e of the product and quantity r e tu r n e d middot Product details such as the batch number and expiry date middot Condition in which received middot Reason for returning products middot Compensatory measures taken wi t h r e s p e c t t o c l i e n t middot Action taken with respect to product middot Name and signature of the personnel accepting the returned medicines and recording details middot Name and signature of the chief pharmacist verifying the recorded details

What the pharmacist would have learnt from this module The storage of medicines is a critical factor in the distribution cycle bullbull Stocks received by the pharmacy should be quarantined in a separate area and necessary checks s h o u ld be performed to ascertain the qua lity a nd quantity of stocks received bullbull Whatever pattern and means of storage used the products should be stored so as to maintain their potency and integrity bullbull Storage conditions should be monitored and maintained on a regular basis bullbull Optimum stock levels should be maintained and regularly monitored for expiry bullbull The design of storage areas should facilitate appropriate storage of medicines bullbull Cleanliness should be maintained in the pharmacy bullbull Adequate measures should be taken in case of returned medicines and recalled products

Optimum storage of medicines is mandatory whether at the distribution stage at the pharmacy or ultimately within the homes of patients The pharmacist has an important r o l e t o p l a y i n t h e s t o r a g e o f m e d i c i n e s i n m a i n t a i n i n g d r u g p o t ency and efficacy and thus facilitating optimum therapeutic benefits Good Pharmacy Practice - IPA -CDSCO - WHO Appendix I Quality Assurance Templates of letters for use if found not of Standard Quality [Frozen and expired goods ]

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated To Name of the Supplier with address

Sub Not of Standard Quality GoMP-Supply of Drugs and medicines-(Codename) Return of Stocks to the Suppliers-reg(New drug policy 2009) Previous letterinvoice ref Sl No Drug Code Drug name

Manufacturing date Expiry date

Supplier address

B a t c h n o

The above items of PO nodated was drawn by the Drug Inspector (Place) on (______________date) as a statutory sampling and declared ldquoNot of Standard

59

Qualityrdquo on -(______________date) by the Government Analyst for the following reasons

- ldquoThe product sample do not confirm to IP specification for (Drug codename with respect to the content of drugrdquo

- ldquoThe product has already been blacklisted by TNMSC on -(______________date) for the failure of (quantity) of batches of drug codenamerdquo

As per the clause of the te nde r d oc um e nt ldquo I f the sa mple s d o not c onf o r m to statutory standardsthe tenderer will be liable for relevant action under the existing laws and the entire stock in such batch should be taken back by the tenderer within a period of 30 days o f t h e r e c e i p t o f t h e l e t t e r f r o m t h e v e n u e

The stock shall be taken back at the expenses of the tendererthe Procurement Authority have the right to destroy such Not of Standard Quality if the tenderer does not take back the goods within the stipulated time

The Procuring Authority will arrange to destroy the Not of Standard Quality drugs within 90 days after the expiry of 30 days mentioned above without further notice and shall also collect demurrage charges calculated at the rate of 2 per week on the value of the drugs rejected till such destructionrdquo

Hence we regret to inform you that you will have to take back the stocks available of the abovesaid batch at your own cost from the drug stores where you have supplied the above batch

Kindly acknowledge the receipt of this reference at once

P r o c u r e m e n t A u t h o r i t y Seal and Stamp

Copy to Ref No dated

1 ) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated13082010

To

Sub Frozen Drugs-ordered to return to the Suppliers-reg(New drug policy 2009) Previous letterinvoice ref

The following products which were earlier frozen have now been ordered to return to suppliers directly with permission from the State drug Authority In this regard the suppliers have been instructed to take back their failed batch from the drug store of the stores Hence you are now instructed to return the following failed batches to the suppliers by obtaining proper authorization letter and acknowledgements from them

60

Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

Kindly acknowledge the receipt of this reference at once

Procurement Authority Seal and Stamp

Copy to

Ref No dated 2) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated14092010

To

Sub Frozen Drugs-ordered to return to the Suppliers- for issue of gate pass after verification reg(New drug policy 2009) Previous letterinvoice ref

The following products which were earlier frozen have now been released Hence they may be issued Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

Kindly acknowledge the receipt of this reference at once

Procurement Authority Seal and Stamp

Copy to

61

Ref No dated 3) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated

To

Sub Stop instruction-reg(New drug policy 2009) Previous letterinvoice ref

Until further instructions stop issue all the batches of the following item Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

You must intimate the available stock in the stores of the said batch Number to the Procurement Authority immediately Also retrieve quantity if already issued

Procurement Authority Seal and Stamp

Copy to

Ref No dated 4) HOD Procurement Office of

62

Appendix II Material handling in drug stores

Rack approx rates and dimensions

S No

Item Description UOM Approx Rate

1 MEDIUM DUTY RACK SIZE 2900 H X 3090 W X 800 D IN MM (AS PER SPECIFICATION)

Each 2499800

2 MEDIUM DUTY RACK ADD ON UNIT FOR SIZE OF SR NO2

Each 2243100

To locate a Box no 3 Rack no 14 in row3

SAMPLE OF RACK no Bin numbering -------------- S a y R K 1 4 R o w 3 B o x 1 6

SAMPLE LAYOUT of RACKS in a Drug Stores

63

Sample of another warehouse of distribution warehouse system

64

65

Slotted Angle racks with bin cards

66

Plastic Pallets

Plastic pallets ar e l i g h t w e i g h t l o w- c ost and exceed industry standards for strength and durability

NOTE A pallet has bottom deckboards (see sketch) A skid does not have bottom

67

deckboards

Battery Operated Stacker

Electric Stacker Ehh (Manual Push Type) - Manual drive - Lifting electrically with Battery 12 V 88 Ah - For loading and un-loading of trucks - Battery and loading device built - in - Battery charge gauge and charging current gauge Simple and Easy Operation - Lifting and Lowering electrically direct on steering arm - Pulling and pushing through steering arm - Electrically operated relief valve on hydraulic aggregate Safe Operation - Emergency Off Switch - Constant lowering speed - Protection through lowering brake valve - Overload protection through overload brake valve - Load chains covered preventing pinching threat - Electrically interlocking during loading process - Secured battery compartment opens upwardly - Stable buffering of the steering arm in upright position - In accordance with EWG Guidelines 89 240 - In accordance with VBG 12b Prevention of Accidents

Pallet Truck [ Top ]

68

----------------------------------------------------------------------------------------------------------------------------

For Transport Of All Goods On Pallets Safe and Easy Operation - through single hand operation Lifting moving

lowering with steering handle - neutral position of the hydraulic possible - overload pressure relief valve Long Service Life - robust co n s t r u c t i o n

- special hardened axles - hardened chromium plated ram - maintenance free Easy Maneuverability - through rubber steering rollers - nylon fork rollers

A h a n d t r o l l e y

69

Trolley with plastic bins for several items del ivery

70

Digital Weighing balances

Balances amp Scales EF Seriers Precision Electronic Balance

71

1

Ice lined Refrigerators

600 litres refrigrator

72

Walk in cooler

vacuum cleaner

73

middot N a m e o f t h e p a t i e n t middot Nam e of the product and quantity r e tu r n e d middot Product details such as the batch number and expiry date middot Condition in which received middot Reason for returning products middot Compensatory measures taken wi t h r e s p e c t t o c l i e n t middot Action taken with respect to product middot Name and signature of the personnel accepting the returned medicines and recording details middot Name and signature of the chief pharmacist verifying the recorded details

What the pharmacist would have learnt from this module The storage of medicines is a critical factor in the distribution cycle bullbull Stocks received by the pharmacy should be quarantined in a separate area and necessary checks s h o u ld be performed to ascertain the qua lity a nd quantity of stocks received bullbull Whatever pattern and means of storage used the products should be stored so as to maintain their potency and integrity bullbull Storage conditions should be monitored and maintained on a regular basis bullbull Optimum stock levels should be maintained and regularly monitored for expiry bullbull The design of storage areas should facilitate appropriate storage of medicines bullbull Cleanliness should be maintained in the pharmacy bullbull Adequate measures should be taken in case of returned medicines and recalled products

Optimum storage of medicines is mandatory whether at the distribution stage at the pharmacy or ultimately within the homes of patients The pharmacist has an important r o l e t o p l a y i n t h e s t o r a g e o f m e d i c i n e s i n m a i n t a i n i n g d r u g p o t ency and efficacy and thus facilitating optimum therapeutic benefits Good Pharmacy Practice - IPA -CDSCO - WHO Appendix I Quality Assurance Templates of letters for use if found not of Standard Quality [Frozen and expired goods ]

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated To Name of the Supplier with address

Sub Not of Standard Quality GoMP-Supply of Drugs and medicines-(Codename) Return of Stocks to the Suppliers-reg(New drug policy 2009) Previous letterinvoice ref Sl No Drug Code Drug name

Manufacturing date Expiry date

Supplier address

B a t c h n o

The above items of PO nodated was drawn by the Drug Inspector (Place) on (______________date) as a statutory sampling and declared ldquoNot of Standard

59

Qualityrdquo on -(______________date) by the Government Analyst for the following reasons

- ldquoThe product sample do not confirm to IP specification for (Drug codename with respect to the content of drugrdquo

- ldquoThe product has already been blacklisted by TNMSC on -(______________date) for the failure of (quantity) of batches of drug codenamerdquo

As per the clause of the te nde r d oc um e nt ldquo I f the sa mple s d o not c onf o r m to statutory standardsthe tenderer will be liable for relevant action under the existing laws and the entire stock in such batch should be taken back by the tenderer within a period of 30 days o f t h e r e c e i p t o f t h e l e t t e r f r o m t h e v e n u e

The stock shall be taken back at the expenses of the tendererthe Procurement Authority have the right to destroy such Not of Standard Quality if the tenderer does not take back the goods within the stipulated time

The Procuring Authority will arrange to destroy the Not of Standard Quality drugs within 90 days after the expiry of 30 days mentioned above without further notice and shall also collect demurrage charges calculated at the rate of 2 per week on the value of the drugs rejected till such destructionrdquo

Hence we regret to inform you that you will have to take back the stocks available of the abovesaid batch at your own cost from the drug stores where you have supplied the above batch

Kindly acknowledge the receipt of this reference at once

P r o c u r e m e n t A u t h o r i t y Seal and Stamp

Copy to Ref No dated

1 ) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated13082010

To

Sub Frozen Drugs-ordered to return to the Suppliers-reg(New drug policy 2009) Previous letterinvoice ref

The following products which were earlier frozen have now been ordered to return to suppliers directly with permission from the State drug Authority In this regard the suppliers have been instructed to take back their failed batch from the drug store of the stores Hence you are now instructed to return the following failed batches to the suppliers by obtaining proper authorization letter and acknowledgements from them

60

Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

Kindly acknowledge the receipt of this reference at once

Procurement Authority Seal and Stamp

Copy to

Ref No dated 2) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated14092010

To

Sub Frozen Drugs-ordered to return to the Suppliers- for issue of gate pass after verification reg(New drug policy 2009) Previous letterinvoice ref

The following products which were earlier frozen have now been released Hence they may be issued Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

Kindly acknowledge the receipt of this reference at once

Procurement Authority Seal and Stamp

Copy to

61

Ref No dated 3) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated

To

Sub Stop instruction-reg(New drug policy 2009) Previous letterinvoice ref

Until further instructions stop issue all the batches of the following item Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

You must intimate the available stock in the stores of the said batch Number to the Procurement Authority immediately Also retrieve quantity if already issued

Procurement Authority Seal and Stamp

Copy to

Ref No dated 4) HOD Procurement Office of

62

Appendix II Material handling in drug stores

Rack approx rates and dimensions

S No

Item Description UOM Approx Rate

1 MEDIUM DUTY RACK SIZE 2900 H X 3090 W X 800 D IN MM (AS PER SPECIFICATION)

Each 2499800

2 MEDIUM DUTY RACK ADD ON UNIT FOR SIZE OF SR NO2

Each 2243100

To locate a Box no 3 Rack no 14 in row3

SAMPLE OF RACK no Bin numbering -------------- S a y R K 1 4 R o w 3 B o x 1 6

SAMPLE LAYOUT of RACKS in a Drug Stores

63

Sample of another warehouse of distribution warehouse system

64

65

Slotted Angle racks with bin cards

66

Plastic Pallets

Plastic pallets ar e l i g h t w e i g h t l o w- c ost and exceed industry standards for strength and durability

NOTE A pallet has bottom deckboards (see sketch) A skid does not have bottom

67

deckboards

Battery Operated Stacker

Electric Stacker Ehh (Manual Push Type) - Manual drive - Lifting electrically with Battery 12 V 88 Ah - For loading and un-loading of trucks - Battery and loading device built - in - Battery charge gauge and charging current gauge Simple and Easy Operation - Lifting and Lowering electrically direct on steering arm - Pulling and pushing through steering arm - Electrically operated relief valve on hydraulic aggregate Safe Operation - Emergency Off Switch - Constant lowering speed - Protection through lowering brake valve - Overload protection through overload brake valve - Load chains covered preventing pinching threat - Electrically interlocking during loading process - Secured battery compartment opens upwardly - Stable buffering of the steering arm in upright position - In accordance with EWG Guidelines 89 240 - In accordance with VBG 12b Prevention of Accidents

Pallet Truck [ Top ]

68

----------------------------------------------------------------------------------------------------------------------------

For Transport Of All Goods On Pallets Safe and Easy Operation - through single hand operation Lifting moving

lowering with steering handle - neutral position of the hydraulic possible - overload pressure relief valve Long Service Life - robust co n s t r u c t i o n

- special hardened axles - hardened chromium plated ram - maintenance free Easy Maneuverability - through rubber steering rollers - nylon fork rollers

A h a n d t r o l l e y

69

Trolley with plastic bins for several items del ivery

70

Digital Weighing balances

Balances amp Scales EF Seriers Precision Electronic Balance

71

1

Ice lined Refrigerators

600 litres refrigrator

72

Walk in cooler

vacuum cleaner

73

Qualityrdquo on -(______________date) by the Government Analyst for the following reasons

- ldquoThe product sample do not confirm to IP specification for (Drug codename with respect to the content of drugrdquo

- ldquoThe product has already been blacklisted by TNMSC on -(______________date) for the failure of (quantity) of batches of drug codenamerdquo

As per the clause of the te nde r d oc um e nt ldquo I f the sa mple s d o not c onf o r m to statutory standardsthe tenderer will be liable for relevant action under the existing laws and the entire stock in such batch should be taken back by the tenderer within a period of 30 days o f t h e r e c e i p t o f t h e l e t t e r f r o m t h e v e n u e

The stock shall be taken back at the expenses of the tendererthe Procurement Authority have the right to destroy such Not of Standard Quality if the tenderer does not take back the goods within the stipulated time

The Procuring Authority will arrange to destroy the Not of Standard Quality drugs within 90 days after the expiry of 30 days mentioned above without further notice and shall also collect demurrage charges calculated at the rate of 2 per week on the value of the drugs rejected till such destructionrdquo

Hence we regret to inform you that you will have to take back the stocks available of the abovesaid batch at your own cost from the drug stores where you have supplied the above batch

Kindly acknowledge the receipt of this reference at once

P r o c u r e m e n t A u t h o r i t y Seal and Stamp

Copy to Ref No dated

1 ) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated13082010

To

Sub Frozen Drugs-ordered to return to the Suppliers-reg(New drug policy 2009) Previous letterinvoice ref

The following products which were earlier frozen have now been ordered to return to suppliers directly with permission from the State drug Authority In this regard the suppliers have been instructed to take back their failed batch from the drug store of the stores Hence you are now instructed to return the following failed batches to the suppliers by obtaining proper authorization letter and acknowledgements from them

60

Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

Kindly acknowledge the receipt of this reference at once

Procurement Authority Seal and Stamp

Copy to

Ref No dated 2) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated14092010

To

Sub Frozen Drugs-ordered to return to the Suppliers- for issue of gate pass after verification reg(New drug policy 2009) Previous letterinvoice ref

The following products which were earlier frozen have now been released Hence they may be issued Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

Kindly acknowledge the receipt of this reference at once

Procurement Authority Seal and Stamp

Copy to

61

Ref No dated 3) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated

To

Sub Stop instruction-reg(New drug policy 2009) Previous letterinvoice ref

Until further instructions stop issue all the batches of the following item Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

You must intimate the available stock in the stores of the said batch Number to the Procurement Authority immediately Also retrieve quantity if already issued

Procurement Authority Seal and Stamp

Copy to

Ref No dated 4) HOD Procurement Office of

62

Appendix II Material handling in drug stores

Rack approx rates and dimensions

S No

Item Description UOM Approx Rate

1 MEDIUM DUTY RACK SIZE 2900 H X 3090 W X 800 D IN MM (AS PER SPECIFICATION)

Each 2499800

2 MEDIUM DUTY RACK ADD ON UNIT FOR SIZE OF SR NO2

Each 2243100

To locate a Box no 3 Rack no 14 in row3

SAMPLE OF RACK no Bin numbering -------------- S a y R K 1 4 R o w 3 B o x 1 6

SAMPLE LAYOUT of RACKS in a Drug Stores

63

Sample of another warehouse of distribution warehouse system

64

65

Slotted Angle racks with bin cards

66

Plastic Pallets

Plastic pallets ar e l i g h t w e i g h t l o w- c ost and exceed industry standards for strength and durability

NOTE A pallet has bottom deckboards (see sketch) A skid does not have bottom

67

deckboards

Battery Operated Stacker

Electric Stacker Ehh (Manual Push Type) - Manual drive - Lifting electrically with Battery 12 V 88 Ah - For loading and un-loading of trucks - Battery and loading device built - in - Battery charge gauge and charging current gauge Simple and Easy Operation - Lifting and Lowering electrically direct on steering arm - Pulling and pushing through steering arm - Electrically operated relief valve on hydraulic aggregate Safe Operation - Emergency Off Switch - Constant lowering speed - Protection through lowering brake valve - Overload protection through overload brake valve - Load chains covered preventing pinching threat - Electrically interlocking during loading process - Secured battery compartment opens upwardly - Stable buffering of the steering arm in upright position - In accordance with EWG Guidelines 89 240 - In accordance with VBG 12b Prevention of Accidents

Pallet Truck [ Top ]

68

----------------------------------------------------------------------------------------------------------------------------

For Transport Of All Goods On Pallets Safe and Easy Operation - through single hand operation Lifting moving

lowering with steering handle - neutral position of the hydraulic possible - overload pressure relief valve Long Service Life - robust co n s t r u c t i o n

- special hardened axles - hardened chromium plated ram - maintenance free Easy Maneuverability - through rubber steering rollers - nylon fork rollers

A h a n d t r o l l e y

69

Trolley with plastic bins for several items del ivery

70

Digital Weighing balances

Balances amp Scales EF Seriers Precision Electronic Balance

71

1

Ice lined Refrigerators

600 litres refrigrator

72

Walk in cooler

vacuum cleaner

73

Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

Kindly acknowledge the receipt of this reference at once

Procurement Authority Seal and Stamp

Copy to

Ref No dated 2) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated14092010

To

Sub Frozen Drugs-ordered to return to the Suppliers- for issue of gate pass after verification reg(New drug policy 2009) Previous letterinvoice ref

The following products which were earlier frozen have now been released Hence they may be issued Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

Kindly acknowledge the receipt of this reference at once

Procurement Authority Seal and Stamp

Copy to

61

Ref No dated 3) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated

To

Sub Stop instruction-reg(New drug policy 2009) Previous letterinvoice ref

Until further instructions stop issue all the batches of the following item Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

You must intimate the available stock in the stores of the said batch Number to the Procurement Authority immediately Also retrieve quantity if already issued

Procurement Authority Seal and Stamp

Copy to

Ref No dated 4) HOD Procurement Office of

62

Appendix II Material handling in drug stores

Rack approx rates and dimensions

S No

Item Description UOM Approx Rate

1 MEDIUM DUTY RACK SIZE 2900 H X 3090 W X 800 D IN MM (AS PER SPECIFICATION)

Each 2499800

2 MEDIUM DUTY RACK ADD ON UNIT FOR SIZE OF SR NO2

Each 2243100

To locate a Box no 3 Rack no 14 in row3

SAMPLE OF RACK no Bin numbering -------------- S a y R K 1 4 R o w 3 B o x 1 6

SAMPLE LAYOUT of RACKS in a Drug Stores

63

Sample of another warehouse of distribution warehouse system

64

65

Slotted Angle racks with bin cards

66

Plastic Pallets

Plastic pallets ar e l i g h t w e i g h t l o w- c ost and exceed industry standards for strength and durability

NOTE A pallet has bottom deckboards (see sketch) A skid does not have bottom

67

deckboards

Battery Operated Stacker

Electric Stacker Ehh (Manual Push Type) - Manual drive - Lifting electrically with Battery 12 V 88 Ah - For loading and un-loading of trucks - Battery and loading device built - in - Battery charge gauge and charging current gauge Simple and Easy Operation - Lifting and Lowering electrically direct on steering arm - Pulling and pushing through steering arm - Electrically operated relief valve on hydraulic aggregate Safe Operation - Emergency Off Switch - Constant lowering speed - Protection through lowering brake valve - Overload protection through overload brake valve - Load chains covered preventing pinching threat - Electrically interlocking during loading process - Secured battery compartment opens upwardly - Stable buffering of the steering arm in upright position - In accordance with EWG Guidelines 89 240 - In accordance with VBG 12b Prevention of Accidents

Pallet Truck [ Top ]

68

----------------------------------------------------------------------------------------------------------------------------

For Transport Of All Goods On Pallets Safe and Easy Operation - through single hand operation Lifting moving

lowering with steering handle - neutral position of the hydraulic possible - overload pressure relief valve Long Service Life - robust co n s t r u c t i o n

- special hardened axles - hardened chromium plated ram - maintenance free Easy Maneuverability - through rubber steering rollers - nylon fork rollers

A h a n d t r o l l e y

69

Trolley with plastic bins for several items del ivery

70

Digital Weighing balances

Balances amp Scales EF Seriers Precision Electronic Balance

71

1

Ice lined Refrigerators

600 litres refrigrator

72

Walk in cooler

vacuum cleaner

73

Ref No dated 3) HOD Procurement Office of

(Name of Office of the Authority-----------------------------------------) Phone

Ref No dated

To

Sub Stop instruction-reg(New drug policy 2009) Previous letterinvoice ref

Until further instructions stop issue all the batches of the following item Sl No

Drug Code Drug name Manufacturing d a t e Expiry date

Supplier address

Batch no

You must intimate the available stock in the stores of the said batch Number to the Procurement Authority immediately Also retrieve quantity if already issued

Procurement Authority Seal and Stamp

Copy to

Ref No dated 4) HOD Procurement Office of

62

Appendix II Material handling in drug stores

Rack approx rates and dimensions

S No

Item Description UOM Approx Rate

1 MEDIUM DUTY RACK SIZE 2900 H X 3090 W X 800 D IN MM (AS PER SPECIFICATION)

Each 2499800

2 MEDIUM DUTY RACK ADD ON UNIT FOR SIZE OF SR NO2

Each 2243100

To locate a Box no 3 Rack no 14 in row3

SAMPLE OF RACK no Bin numbering -------------- S a y R K 1 4 R o w 3 B o x 1 6

SAMPLE LAYOUT of RACKS in a Drug Stores

63

Sample of another warehouse of distribution warehouse system

64

65

Slotted Angle racks with bin cards

66

Plastic Pallets

Plastic pallets ar e l i g h t w e i g h t l o w- c ost and exceed industry standards for strength and durability

NOTE A pallet has bottom deckboards (see sketch) A skid does not have bottom

67

deckboards

Battery Operated Stacker

Electric Stacker Ehh (Manual Push Type) - Manual drive - Lifting electrically with Battery 12 V 88 Ah - For loading and un-loading of trucks - Battery and loading device built - in - Battery charge gauge and charging current gauge Simple and Easy Operation - Lifting and Lowering electrically direct on steering arm - Pulling and pushing through steering arm - Electrically operated relief valve on hydraulic aggregate Safe Operation - Emergency Off Switch - Constant lowering speed - Protection through lowering brake valve - Overload protection through overload brake valve - Load chains covered preventing pinching threat - Electrically interlocking during loading process - Secured battery compartment opens upwardly - Stable buffering of the steering arm in upright position - In accordance with EWG Guidelines 89 240 - In accordance with VBG 12b Prevention of Accidents

Pallet Truck [ Top ]

68

----------------------------------------------------------------------------------------------------------------------------

For Transport Of All Goods On Pallets Safe and Easy Operation - through single hand operation Lifting moving

lowering with steering handle - neutral position of the hydraulic possible - overload pressure relief valve Long Service Life - robust co n s t r u c t i o n

- special hardened axles - hardened chromium plated ram - maintenance free Easy Maneuverability - through rubber steering rollers - nylon fork rollers

A h a n d t r o l l e y

69

Trolley with plastic bins for several items del ivery

70

Digital Weighing balances

Balances amp Scales EF Seriers Precision Electronic Balance

71

1

Ice lined Refrigerators

600 litres refrigrator

72

Walk in cooler

vacuum cleaner

73

Appendix II Material handling in drug stores

Rack approx rates and dimensions

S No

Item Description UOM Approx Rate

1 MEDIUM DUTY RACK SIZE 2900 H X 3090 W X 800 D IN MM (AS PER SPECIFICATION)

Each 2499800

2 MEDIUM DUTY RACK ADD ON UNIT FOR SIZE OF SR NO2

Each 2243100

To locate a Box no 3 Rack no 14 in row3

SAMPLE OF RACK no Bin numbering -------------- S a y R K 1 4 R o w 3 B o x 1 6

SAMPLE LAYOUT of RACKS in a Drug Stores

63

Sample of another warehouse of distribution warehouse system

64

65

Slotted Angle racks with bin cards

66

Plastic Pallets

Plastic pallets ar e l i g h t w e i g h t l o w- c ost and exceed industry standards for strength and durability

NOTE A pallet has bottom deckboards (see sketch) A skid does not have bottom

67

deckboards

Battery Operated Stacker

Electric Stacker Ehh (Manual Push Type) - Manual drive - Lifting electrically with Battery 12 V 88 Ah - For loading and un-loading of trucks - Battery and loading device built - in - Battery charge gauge and charging current gauge Simple and Easy Operation - Lifting and Lowering electrically direct on steering arm - Pulling and pushing through steering arm - Electrically operated relief valve on hydraulic aggregate Safe Operation - Emergency Off Switch - Constant lowering speed - Protection through lowering brake valve - Overload protection through overload brake valve - Load chains covered preventing pinching threat - Electrically interlocking during loading process - Secured battery compartment opens upwardly - Stable buffering of the steering arm in upright position - In accordance with EWG Guidelines 89 240 - In accordance with VBG 12b Prevention of Accidents

Pallet Truck [ Top ]

68

----------------------------------------------------------------------------------------------------------------------------

For Transport Of All Goods On Pallets Safe and Easy Operation - through single hand operation Lifting moving

lowering with steering handle - neutral position of the hydraulic possible - overload pressure relief valve Long Service Life - robust co n s t r u c t i o n

- special hardened axles - hardened chromium plated ram - maintenance free Easy Maneuverability - through rubber steering rollers - nylon fork rollers

A h a n d t r o l l e y

69

Trolley with plastic bins for several items del ivery

70

Digital Weighing balances

Balances amp Scales EF Seriers Precision Electronic Balance

71

1

Ice lined Refrigerators

600 litres refrigrator

72

Walk in cooler

vacuum cleaner

73

Sample of another warehouse of distribution warehouse system

64

65

Slotted Angle racks with bin cards

66

Plastic Pallets

Plastic pallets ar e l i g h t w e i g h t l o w- c ost and exceed industry standards for strength and durability

NOTE A pallet has bottom deckboards (see sketch) A skid does not have bottom

67

deckboards

Battery Operated Stacker

Electric Stacker Ehh (Manual Push Type) - Manual drive - Lifting electrically with Battery 12 V 88 Ah - For loading and un-loading of trucks - Battery and loading device built - in - Battery charge gauge and charging current gauge Simple and Easy Operation - Lifting and Lowering electrically direct on steering arm - Pulling and pushing through steering arm - Electrically operated relief valve on hydraulic aggregate Safe Operation - Emergency Off Switch - Constant lowering speed - Protection through lowering brake valve - Overload protection through overload brake valve - Load chains covered preventing pinching threat - Electrically interlocking during loading process - Secured battery compartment opens upwardly - Stable buffering of the steering arm in upright position - In accordance with EWG Guidelines 89 240 - In accordance with VBG 12b Prevention of Accidents

Pallet Truck [ Top ]

68

----------------------------------------------------------------------------------------------------------------------------

For Transport Of All Goods On Pallets Safe and Easy Operation - through single hand operation Lifting moving

lowering with steering handle - neutral position of the hydraulic possible - overload pressure relief valve Long Service Life - robust co n s t r u c t i o n

- special hardened axles - hardened chromium plated ram - maintenance free Easy Maneuverability - through rubber steering rollers - nylon fork rollers

A h a n d t r o l l e y

69

Trolley with plastic bins for several items del ivery

70

Digital Weighing balances

Balances amp Scales EF Seriers Precision Electronic Balance

71

1

Ice lined Refrigerators

600 litres refrigrator

72

Walk in cooler

vacuum cleaner

73

65

Slotted Angle racks with bin cards

66

Plastic Pallets

Plastic pallets ar e l i g h t w e i g h t l o w- c ost and exceed industry standards for strength and durability

NOTE A pallet has bottom deckboards (see sketch) A skid does not have bottom

67

deckboards

Battery Operated Stacker

Electric Stacker Ehh (Manual Push Type) - Manual drive - Lifting electrically with Battery 12 V 88 Ah - For loading and un-loading of trucks - Battery and loading device built - in - Battery charge gauge and charging current gauge Simple and Easy Operation - Lifting and Lowering electrically direct on steering arm - Pulling and pushing through steering arm - Electrically operated relief valve on hydraulic aggregate Safe Operation - Emergency Off Switch - Constant lowering speed - Protection through lowering brake valve - Overload protection through overload brake valve - Load chains covered preventing pinching threat - Electrically interlocking during loading process - Secured battery compartment opens upwardly - Stable buffering of the steering arm in upright position - In accordance with EWG Guidelines 89 240 - In accordance with VBG 12b Prevention of Accidents

Pallet Truck [ Top ]

68

----------------------------------------------------------------------------------------------------------------------------

For Transport Of All Goods On Pallets Safe and Easy Operation - through single hand operation Lifting moving

lowering with steering handle - neutral position of the hydraulic possible - overload pressure relief valve Long Service Life - robust co n s t r u c t i o n

- special hardened axles - hardened chromium plated ram - maintenance free Easy Maneuverability - through rubber steering rollers - nylon fork rollers

A h a n d t r o l l e y

69

Trolley with plastic bins for several items del ivery

70

Digital Weighing balances

Balances amp Scales EF Seriers Precision Electronic Balance

71

1

Ice lined Refrigerators

600 litres refrigrator

72

Walk in cooler

vacuum cleaner

73

Slotted Angle racks with bin cards

66

Plastic Pallets

Plastic pallets ar e l i g h t w e i g h t l o w- c ost and exceed industry standards for strength and durability

NOTE A pallet has bottom deckboards (see sketch) A skid does not have bottom

67

deckboards

Battery Operated Stacker

Electric Stacker Ehh (Manual Push Type) - Manual drive - Lifting electrically with Battery 12 V 88 Ah - For loading and un-loading of trucks - Battery and loading device built - in - Battery charge gauge and charging current gauge Simple and Easy Operation - Lifting and Lowering electrically direct on steering arm - Pulling and pushing through steering arm - Electrically operated relief valve on hydraulic aggregate Safe Operation - Emergency Off Switch - Constant lowering speed - Protection through lowering brake valve - Overload protection through overload brake valve - Load chains covered preventing pinching threat - Electrically interlocking during loading process - Secured battery compartment opens upwardly - Stable buffering of the steering arm in upright position - In accordance with EWG Guidelines 89 240 - In accordance with VBG 12b Prevention of Accidents

Pallet Truck [ Top ]

68

----------------------------------------------------------------------------------------------------------------------------

For Transport Of All Goods On Pallets Safe and Easy Operation - through single hand operation Lifting moving

lowering with steering handle - neutral position of the hydraulic possible - overload pressure relief valve Long Service Life - robust co n s t r u c t i o n

- special hardened axles - hardened chromium plated ram - maintenance free Easy Maneuverability - through rubber steering rollers - nylon fork rollers

A h a n d t r o l l e y

69

Trolley with plastic bins for several items del ivery

70

Digital Weighing balances

Balances amp Scales EF Seriers Precision Electronic Balance

71

1

Ice lined Refrigerators

600 litres refrigrator

72

Walk in cooler

vacuum cleaner

73

Plastic Pallets

Plastic pallets ar e l i g h t w e i g h t l o w- c ost and exceed industry standards for strength and durability

NOTE A pallet has bottom deckboards (see sketch) A skid does not have bottom

67

deckboards

Battery Operated Stacker

Electric Stacker Ehh (Manual Push Type) - Manual drive - Lifting electrically with Battery 12 V 88 Ah - For loading and un-loading of trucks - Battery and loading device built - in - Battery charge gauge and charging current gauge Simple and Easy Operation - Lifting and Lowering electrically direct on steering arm - Pulling and pushing through steering arm - Electrically operated relief valve on hydraulic aggregate Safe Operation - Emergency Off Switch - Constant lowering speed - Protection through lowering brake valve - Overload protection through overload brake valve - Load chains covered preventing pinching threat - Electrically interlocking during loading process - Secured battery compartment opens upwardly - Stable buffering of the steering arm in upright position - In accordance with EWG Guidelines 89 240 - In accordance with VBG 12b Prevention of Accidents

Pallet Truck [ Top ]

68

----------------------------------------------------------------------------------------------------------------------------

For Transport Of All Goods On Pallets Safe and Easy Operation - through single hand operation Lifting moving

lowering with steering handle - neutral position of the hydraulic possible - overload pressure relief valve Long Service Life - robust co n s t r u c t i o n

- special hardened axles - hardened chromium plated ram - maintenance free Easy Maneuverability - through rubber steering rollers - nylon fork rollers

A h a n d t r o l l e y

69

Trolley with plastic bins for several items del ivery

70

Digital Weighing balances

Balances amp Scales EF Seriers Precision Electronic Balance

71

1

Ice lined Refrigerators

600 litres refrigrator

72

Walk in cooler

vacuum cleaner

73

deckboards

Battery Operated Stacker

Electric Stacker Ehh (Manual Push Type) - Manual drive - Lifting electrically with Battery 12 V 88 Ah - For loading and un-loading of trucks - Battery and loading device built - in - Battery charge gauge and charging current gauge Simple and Easy Operation - Lifting and Lowering electrically direct on steering arm - Pulling and pushing through steering arm - Electrically operated relief valve on hydraulic aggregate Safe Operation - Emergency Off Switch - Constant lowering speed - Protection through lowering brake valve - Overload protection through overload brake valve - Load chains covered preventing pinching threat - Electrically interlocking during loading process - Secured battery compartment opens upwardly - Stable buffering of the steering arm in upright position - In accordance with EWG Guidelines 89 240 - In accordance with VBG 12b Prevention of Accidents

Pallet Truck [ Top ]

68

----------------------------------------------------------------------------------------------------------------------------

For Transport Of All Goods On Pallets Safe and Easy Operation - through single hand operation Lifting moving

lowering with steering handle - neutral position of the hydraulic possible - overload pressure relief valve Long Service Life - robust co n s t r u c t i o n

- special hardened axles - hardened chromium plated ram - maintenance free Easy Maneuverability - through rubber steering rollers - nylon fork rollers

A h a n d t r o l l e y

69

Trolley with plastic bins for several items del ivery

70

Digital Weighing balances

Balances amp Scales EF Seriers Precision Electronic Balance

71

1

Ice lined Refrigerators

600 litres refrigrator

72

Walk in cooler

vacuum cleaner

73

----------------------------------------------------------------------------------------------------------------------------

For Transport Of All Goods On Pallets Safe and Easy Operation - through single hand operation Lifting moving

lowering with steering handle - neutral position of the hydraulic possible - overload pressure relief valve Long Service Life - robust co n s t r u c t i o n

- special hardened axles - hardened chromium plated ram - maintenance free Easy Maneuverability - through rubber steering rollers - nylon fork rollers

A h a n d t r o l l e y

69

Trolley with plastic bins for several items del ivery

70

Digital Weighing balances

Balances amp Scales EF Seriers Precision Electronic Balance

71

1

Ice lined Refrigerators

600 litres refrigrator

72

Walk in cooler

vacuum cleaner

73

Trolley with plastic bins for several items del ivery

70

Digital Weighing balances

Balances amp Scales EF Seriers Precision Electronic Balance

71

1

Ice lined Refrigerators

600 litres refrigrator

72

Walk in cooler

vacuum cleaner

73

Digital Weighing balances

Balances amp Scales EF Seriers Precision Electronic Balance

71

1

Ice lined Refrigerators

600 litres refrigrator

72

Walk in cooler

vacuum cleaner

73

1

Ice lined Refrigerators

600 litres refrigrator

72

Walk in cooler

vacuum cleaner

73

Walk in cooler

vacuum cleaner

73