1

Pharmacy

Bulletin

Hospital Jasin

September 2014

Volume 1/2014

Topical Steroids

Risk of Pure Red Cell Aplasia

associated with Erythropoetin

Stimulating Agents

Cancellation of Registration of Traditional Products

Cancellation of Notification of Cosmetic Products

G6PD & Medications

2

Contents

SEPTEMBER 2014

3-7 Topical Steroids

8-10 Risk of Pure Red Cell Aplasia associated with Erythropoetin

Stimulating Agents 11 Cancellation Of Registration Of Traditional Products

12-13 Cancellation Of Notification Of Cosmetic Products 14-15 G6PD And Medicines

16 Pharmacy Activity 17 The Best Sub Store Award In

Hospital Jasin 18 CME Organised By Pharmacy 19 Best Pharmacy Staff Of The Month

20 Go Green Poster

Editorial Board

Advisor Dr Zaleha Bt Md Noor

Chief Editor Pn. Nursahjohana Md Sahak

Editor Ng Shy Pyng

Contributors

Low Jia Hui

Siti Maslizah Bte Seto Ng Kah Yeang

3

Topical Steroids By Ng Kah Yeang

Key Points

Topical steroids can be

used to treat psoriasis,

lichen sclerosus , atopic

d e r ma t i t i s , e cz e ma ,

v i t i l i g o a n d a c u t e

radiation dermatitis

Ultra-high-potency topical

steroids should not be used

continuously for longer

than three weeks

Recommended duration

for low- to high-potency

topical steroids should not

exceed three months to

avoid side effects.

Combinations of topical

steroids and antifungal

agents generally should be

avoided to reduce the risk

of tinea infections.

Common Conditions Treatable with Topical

Steroids1

4

Vehicles

Creams:

Recommended for acute

exudative inflammation due

to their drying effects and

intertriginous areas where

ointments may not be

used. Does not provide

occlusive effect and less

potent than ointment but

more cosmetic appealing.

Ointments:

Provide more lubrication

and occlusion than other

preparations, and are the

most useful for treating dry

or thick, hyperkeratotic

lesions thus lead to higher

of rate of absorption.

Lotions and gels:

The least greasy and

occlusive of all topical

steroid vehicles. The drying

effect of alcohol in lotion is

useful for hairy areas because

they penetrate easily and

leave little residue. The

drying effect of gel is useful

for scalp or other hairy areas

application and exudative

inflammation, such as

poison ivy.

Potency

Low potency :

The safest agents for

long-term use, on large

surface areas, on the face or

areas of the body with thin-

ner skin, and on children. 2

More potent agents:

Beneficial for severe

diseases and for areas of the

body where the skin is

thicker, such as the palms

and bottoms of the feet. 2

High- and ultra-high-

potency steroids:

Avoid face, groin or axilla.2

5

TOPICAL STEROID POTENCIES

Class 1 Very potent or superpotent (up to 600 times as potent as hydrocortisone)

Clobetasol propionate Cloderm 0.05% Micronized Clobetasol propionate cream/ointment /

Shampoo

Axcel Clobetasol 0.05%cream/ointment

Clobet 0.05% Cream

Dermovate 0.05 % cream/ointment

Betamethasone dipropionate Beprosone 0.064 % cream/ointment

Class 2 Potent (100-150 times as potent as hydrocortisone)

Betamethasone valerate* ( 1:4, 1:6, 1:10) Axcel Fusidic Acid-B cream Fusidic acid 2%,

Betamethasone 17-valerate 0.1%*

Beavate Betamethasone 17-Valerate 0.1% Cream

Benosone Micronized Betamethasone valerate 0.1% Cream/Ointment*

Benosone-N Micronized Betamethasone valerate 0.1% and Micronized

Neomycin sulphate 0.5% Cream/Ointment

Betamethasone dipropionate*

Beprosone Micronized Betamethasone dipropionate 0.05%

Cream/Ointment

Beprosalic Betamethasone dipropionate 0.05%,

salicylic acid 3% Ointment

Beprosalic Betamethasone dipropionate 0.064%,

salicylic acid 2% Lotion

Beprogel Betamethasone dipropionate 0.05% topical solution

Diflucortolone valerate Isoradin cream isoconazole nitrate 10 mg, diflucortolone valerate 1 mg

Travocort Isoconazole nitrate 10 mg, diflucortolone valerate 1 mg

Hydrocortisone 17-butyrate

Mometasone furoate* Elosone Micronized Mometasone furoate 0.1% cream/ointment /

Lotion

Methylprednisolone aceponate (Advantan™ cream/ointment)

Class 3 Moderate (2-25 times as potent as hydrocortisone)

Clobetasone butyrate* U-Closone Micronized Clobetasone butyrate 0.05% Cream*/Ointment

Triamcinolone acetonide Tramsone Micronized Triamcinolone acetonide 0.1% Cream

Flucinolone acetonide Fluciderm Micronized Flucinolone acetonide 0.025% Cream

Class 4 Mild

Hydrocortisone* Daktacort™ cream

HCORT Hydrocortisone 1% Cream/Ointment

Hydrocortisone 2.5% Cream

* Available in Hospital Jasin, Melaka

6

Frequency of Administration and Duration of Treatment

Frequency: Once-or twice-daily application is sufficient as more frequent application

does not proof to be better result.3

Duration: Max of three weeks continuously for high potency. If a longer duration is

needed, at least one week of steroid free period before resuming the treatment.3 Side

effects are rare even for high potency when used for three months or less, except in face

or neck. 3

Quantity of Cream/Ointment Based on Fingertip Units

AREA OF THE BODY

FINGERTIP UNIT REQUIRED FOR ONE APPLICA-TION

WEIGHT OF OINTMENT RE-QUIRED FOR ONE APPLICA-TION (G)

WEIGHT OF OINTMENT RE-QUIRED FOR AN ADULT MALE TO TREAT TWICE DAILY FOR ONE WEEK (G)

Face and neck 2.5 1.25 17.5

Trunk (front or back)

7 3.5 49

One arm 3 1.5 21

One hand (one side)

0.5 0.25 3.5

One leg 6 3 42

One foot 2 1 14

A fingertip unit is defined as the amount that can be squeezed from the fingertip to the

first crease of the finger.

One fingertip unit = approximately 0.5 g.

One hand-size area (i.e., the area of one side of the hand) of skin requires 0.5 fingertip

units or 0.25g of steroid. 4

7

Side Effects

Potential Side Effects of Topical Corticosteroids

Cutaneous/local effects

Atrophic changes Easy bruising, Increased fragility, Purpura

Infections Aggravation of cutaneous infection, Masked infection (tinea incognito)

Ocular changes Glaucoma

Miscellaneous Contact dermatitis, Delayed wound healing, Hyperpigmentation

Systemic effects

Endocrine Cushing disease, Hypothalamic-pituitary-adrenal suppression

Metabolic Decreased growth rate, Hyperglycemia

Renal/electrolyte Hypertension, Hypocalcemia, Peripheral edema

According to a postmarketing safety review, the most frequently reported side effects

were local irritation (66%), skin discoloration (15%), and striae or skin atrophy

(15%).5

References

1. Jonathan D France. Choosing Topical Corticosteroids Am Fam Physician. 2009 Jan 15;79(2):135

140

2. Geraci AC, Crane JS, Cunha BA. Topical steroids: dosing forms and general considerations.Hosp

Pharm. 1991;26:699–719.

3. Drake LA, Dinehart SM, Farmer ER, et al. Guidelines of care for the use of topical

glucocorticosteroids. J Am Acad Dermatol. 1996;35(4):615–619.

4. Long CC, Finaly AY. The finger-tip unit—a new practical measure. Clin Exp Dermatol.

1991;16(6):444–447.

5. Hengge UR, Ruzicka T, Schwartz RA, Cork MJ. Adverse effects of topical glucocorticosteroids.J Am

Acad Dermatol. 2006;54(1):1–15.

8

Risk of Pure Red Cell Aplasia

associated with Erythropoetin

Stimulating Agents

By Low Jia Hui

Between year 2000 and October 2013,

51 suspected cases of Pure Red Cell

Aplasia (PRCA) involves 2 products

containing Erythropoetin Stimulating

Agents (ESAs) i.e. Eprex® and

Recormon® have been reported to

National Pharmaceutical Control

Bureau (NPCB) Malaysia.

Of the 51 cases, 27 (52%) shows the

presence of anti -erythropoetin

antibodies.

Amongst the 27 confirmed cases of

ESA-induced PRCA, 7 (26%) cases

involved Eprex®, 19 (70%) related to

Recormon®, 1 (4%) involved both

products.

Majority (89%) of the adverse events

occurred as a result of subcutaneous

administration of ESAs.

In October 2013, Singapore Health Sciences

Authority has issued a statement regarding the

co n t r a ind ica t io n o f sub cutaneo us

administration of Eprex in chronic kidney

disease patients following 9 confirmed cases

of ESAs-induced PRCA in which 8 of the

cases involved subcutaneous administration of

ESAs.

PRCA is a severe form of anaemia which

occurs progressively with sudden onset. The

red cell precursors are almost completely

absent from the bone marrow of individual

affected by PRCA. The blood reticulocyte

count is extremely low (< 10 000/ mm3)

However, the number of precursors of white

cells and platelet remain normal.

9

Transfusion of red blood is required for

PRCA patients in order to maintain

appropriate haemoglobin level.

PRCA can also as a result of

lymphoproliferative disorders, systemic

l u p u s , u s e o f c e r t a i n d r u g s

(eg. chloramphenicol), infections

(particularly Parvovirus B19), thymoma or

occur idiopathically.

The diagnosis of ESA induced PRCA is

based on the clinical presentations and the

presence anti-erythropoetin (anti-Epo)

antibodies.

ESAs has been indicated for the treatment

of anaemia in patients with chronic kidney

disease as well as anaemia following

chemotherapy. It is also used to treat

anaemia before certain surgeries and HIV

patients who are taking zidovudine.

Product license holders are providing the

anti-Epo antibody test in the efforts to

minimize the risk of PRCA.

However, the medical specialist will have

to comply with the checklist outlined by

the company in order to send the sample

for test.

Generally, it has been known that the

subcutaneous administration of ESA has

higher risk of immunogenicity compared to

IV administration. In view of the adverse

reactions observed, IV administration of

ESA should be the first choice for

haemodialysis patients as there is already

an intravenous access.

Nevertheless, subcutaneous route remain

the choice for patients undergoing

Continuous Ambulatory Peritoneal Dialy-

sis (CAPD) due to the convenience and the

less dose required.

Healthcare professionals should consider

the possibility of PRCA if a patient

experiences declining haemoglobin level

despite the ESAs treatment.

The storage temperature of 2-8 ◦C for ESAs

products need to be strictly followed as

higher temperature can prompt the

formation of antibody upon injection.

Healthcare professionals are urged to

report any suspected PRCA case they come

across to NPCB so that appropriate

measures can be implemented to ensure

medication safety.

10

Curr

entl

y,

ther

e ar

e 5

pre

par

atio

ns

of

ES

A r

egis

tere

d w

ith D

rug C

ontr

ol

Auth

ori

ty (

DC

A)

of

Mal

aysi

a.

No.

Bra

nd

A

ctiv

e In

gre

die

nts

Y

ear

Reg

is-

tere

d w

ith

DC

A

Pro

du

ct L

icen

se H

old

er

1

Epre

x

Epoet

in a

lfa

1996

Johnso

n&

Johnso

n (

M)

Sdn

Bhd

2

Rec

orm

on

E

poet

in b

eta

2002

Roch

e (M

) S

dn B

hd

3

Mir

cera

M

ethox

y p

oly

eth

yle

ne

gly

col

Epoet

in b

eta

2008

Roch

e (M

) S

dn B

hd

4

Bin

ocr

it

(Bio

sim

ilar

to E

pre

x)

Epoet

in a

lfa

2011

Novar

tis

(M)

Sdn B

hd

5

Nes

p

Dar

bep

oet

in a

lfa

2011

Sm

art

Med

icin

e S

dn B

hd

Refe

ren

ces

1.

Min

istr

y o

f H

ealt

h,

Mala

ysi

a D

rug F

orm

ula

ry 1

/20

14

2.

Cir

cula

r N

atio

nal

Phar

mac

euti

cal

Co

ntr

ol

Bure

au,

MO

H M

alaysi

a (R

ef:

25

.dlm

.BP

FK

/17

/9)

Ma

klu

ma

n S

tatu

s K

esel

am

ata

n

B

agi

Kes

an A

dve

rs P

ure

Red

Cel

l A

pla

sia (

PR

CA

) B

erka

ita

n E

ryth

rop

oeti

n S

tim

ula

tin

g A

gen

ts (

ES

As)

3.

Eck

ardt,

K-U

and C

asad

evall

, N

“P

ure

Red

-cel

l A

pla

sia

due

to A

nti

-ery

thro

po

etin

Anti

bo

die

s” N

eph

ro D

ial

Tra

nsp

lan

t

(2003)

18

: 865

-869

4.

Wis

h,

JB “

Ery

thro

poes

is-s

tim

ula

ting A

gen

ts a

nd

Pure

Red

-cell

Ap

lasi

a:

Yo

u C

an’t

Fo

ol

Mo

ther

Nat

ure

” K

idn

ey

Inte

rnati

onal

(2011)

80

: 11

-13

11

Cancellation of Registration of Traditional Products

By Siti Maslizah Bte Seto

No. Name of Product Registration Number Detected Poison

1 JINGZHI YINQIAO

JIEDU TABLET 260

MG

MAL06071213T PARACETAMOL

2 Sta-lions MAL08091457TC TADALAFIL

3 COSA GRANDE

PLATINUM CAPSULE

350MG

MAL10043765TC AVANAFIL

4 VITAL + ESSENCE

CAPSULE MAL20040210T NORTADALAFIL

5 PAO NI KANG MAL20033586T REPAGLINIDE

6 JT Cordyceps Mycelium MAL09080820T THIODIMETYL-

SILDENAFIL

(ANALOGUE

SILDENAFIL)

7 CAPSUL BENKWAT

GINSENG PLUS 500

MG

MAL07031076T YOHIMBINE

8 Jin Fei Cao San Extract

Powder "Sheng Chang"

MAL09111756T EPHEDRINE AND

PSEUDOEPHEDRINE

9 MYMEN PLUS Capsule

400mg

MAL09082840TC TADALAFIL

12

Cancellation of Notification of Cosmetic Products

By Siti Maslizah Bte Seto

No Image of

Product

Name of

Product

Notification

Number

Detected

Scheduled

Poison

1 AS Beauty Night

Cream NOT101103172K Mercury

2 AS Beauty Day

Cream

NOT101103272K Mercury

3 Golden Horse

Herbal Milk

Lotion – GH507

NOT120905457K Mercury

4 Golden Horse Bio

Complex

Cream – GH903-2

NOT120905465K Mercury

5 Dermaceutic Spot

Cream

NOT101104772K Hydroquinone and

Tretinoin

13

6 Dermaceutic

Spot Peel Cream

NOT101104771K Hydroquinone and

Tretinoin

7 Yellow Cream

(Krim Ku-Neng)

NOT120101719K Hydroquinone

8 Dnars Magic Gold

Foundation

NOT111001084K Hydroquinone

9 Sensual Meiji Skin

Renewar Cream NOT120204451K Acid Azelaic

References

1. http://portal.bpfk.gov.my/index.cfm?&menuid=117&parentid=116

2. http://portal.bpfk.gov.my/index.cfm?&menuid=118&parentid=116

10 Acrena Pure

Herbal Papaya

Soap

NOT100802337K Tretinoin

14

G6PD

By Ng Shy Pyng

Glucose-6-phosphate dehydro-

genase deficiency (also called

G6PD Deficiency) is a genetic

disorder that mainly affects red

blood cells, which carry oxygen

from the lungs to tissues through-

out the body. A defect in an

enzyme called glucose-6-

phosphate dehydrogenase causes

red blood cells to break down

prematurely (hemolysis).

This can cause hemolytic anemia,

which can lead to symptoms of

paleness, yellowing of the skin

and whites of the eyes (jaundice),

dark urine, fatigue, shortness of

breath, and a rapid heart rate.

Factors such as infections, certain

drugs, or foods can increase the

levels of reactive oxygen species,

causing red blood cells to be de-

stroyed faster than the body can

replace them. A reduction in the

amount of red blood cells causes

the signs and symptoms of

hemolytic anemia.

AND Medicines

References

1. http://online1.mimsgateway.com.my/

2. http://g6pddeficiency.org/wp/#.VA_IaKPp1Nk

15

Medications to Avoid (High Risk) Safe to take (Normal therapeutic doses)

(Low Risk)

Anagelsics

Acetylsalicylic acid * Metamizole

Phenacetin Phenazopyridine

Acetanilide

Aminophenazone Paracetamol*

Phenazone Tiaprofenic acid

Phenylbutazone

Anthelmintics

Niridazole Stibophen

Antibiotics

Chloramphenicol* Sulfapyridine

Furazolidone Sulfasalazine*

Nitrofurantoin Sulfadimidine

Nitrofural Sulfafurazone

Ciprofloxacin * Sulfamethoxazole*

Nalidixic acid Sulfanilamide

Sulfacetamide

Norfloxacin

Sulfadiazine

Sulfaguanidine

Sulfamethoxypyridazine

Trimethoprim

Anticonvulsants

Phenytoin *

Antidiabetics

Glibenclamide*

Antidotes

Dimercaprol

Antihistamines

Antazoline Tripelennamine

Diphenhydramine *

Antimalarials

Chloroquine Pamaquine

Mepacrine

Proguanil Quinine

Pyrimethamine Quinidine

Antimycobacterials

Dapsone Isoniazid * Streptomycin *

Antiparkinsonism Agents

Levodopa* Trihexyphenidyl *

Cardiac Drugs

Procainamide Quinidine

Gout Preparations

Probenecid Colchicine*

* Available in Hospital Jasin

16

10,000 Steps Activity: Step Towards Health &

Happiness

On 21 June 2014, 10,000 Steps Activity was organised by Hospital Jasin Pharmacy

at Ayer Keroh Botanical Garden . The objectives of this activity are to:

1) Create health awareness

2) Improve bonding amongst staff

The Participants were staffs from Hospital Jasin and Hospital Alor Gajah.

17

The Best Sub Store Award In Hospital Jasin

14-25 July 2014

Paediatric Ward

1A

UPBS HDU

18

CME Organised By Pharmacy

No. Date Topic of CME

1 27/2/2014 Antifungal Range

2 28/5/2014 Fire Prevention Awareness Talk

3 17/6/2014 Esomeprazole

4 24/6/2014 Insuman Products Information & All Star Pen

Training

5 16/7/2014 Taklimat Carta Perubatan Baru

6 16/7/2014 Medication Errors

7 16/7/2014 Adverse Drug Reaction

8 18/7/2014 Echo Training Technique Of the Inhaler to PPF

9 23/7/2014 Cathejell

10 22/8/2014 Garis Panduan Sistem Pendispendan

Ubat-Ubatan Bersepadu

11 27/8/2014 Discover The Lights, Dydrogesterone In

Threatened Miscarriage

12 02/9/2014 Bisoprolol

13 04/9/2014 Irbesartan

19

June

Nursahjohana Md Sahak

May

Mohd Yusof B. Hamzah

Nur Athirah Haziqah

Mohamad

August

Ng KahYeang

July

20