ms chai's presentation "checklist on self-inspection of private clinics"

8/14/2019 Ms Chai's Presentation "Checklist on Self-Inspection of Private Clinics"

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Checklist on Self-

Inspection of PrivateClinics

By: Cawangan Penguatkuasa

Farmasi Sarawak


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What is the Checklist on Self-

Inspection of Private ClinicsGuide:

To correct the recording of medicines

dispensed to the patient as required by the

law

To instruct on proper labeling, storing and

dispensing of medicines to the patient


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How is the Checklist

regulated?

Checklist sent to all private clinics

To be filled and returned to the Pharmacy

Enforcement department within a month ofreceiving the checklist

Clinic inspections will still be carried out Necessary action will be taken should any aspect

of the law is compromised or violated


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Why recording of Dispensed

Medicine is required?

Provisions of recording stated under:

Poisons Act 1952

Poisons Regulations 1952Poisons (Psychotropic Substances)

Regulations 1989

Dangerous Drugs Act 1952Dangerous Drugs Regulations 1952


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Recording of Dispensed

MedicinePrescription book for sale and supply of

poisons as a dispensed medicine

Prescription Register for PsychotropicSubstances for the sale and supply of

psychotropic substances as dispensed

medicine


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Prescription book

Poisons Act 1952

Poisons are as listed in the First Schedule

S24 PA 1952 states that the sale / supply of apoison as a dispensed medicine should be

recorded in a Prescription book

The sale and supply of poisons should be

recorded on the day the poisons are

supplied


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Format of the prescription

book

Date of sale / supply of medicine and the

serial numberof the entry in such book of

the prescription (if any)

The name of the poison / ingredients, or in

the case of a proprietary medicine, the name

of the medicine and the quantity supplied

Name of patient

Address of the patient


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Checklist Part II

Most Prescription Books do not have the

patients serial number

Requirements of the law serial number (ifany)

Prescription Book in computer form not

printed


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Discrepancies in Recording

Psychotropic substances

Register for psychotropic substances [R19

Poisons (psychotropic regulations) 1989]

One book for all psychotropic substances No balance no stock check conducted

Not updated

Balance of stock in records do not tally with

physical stock


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Discrepancies in Recording


Psychotropic substances not kept under lock

and key

Staff instead of doctor dispensingpsychotropic substances


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Psychotropic substance: as specified in theThird Schedule of the Poisons Act 1952

Regulation 19, Poisons (Psychotropic

Substances) Regulations 1989 Any person who sells / supplies / administers any

psychotropic substance for the purposes ofmedical or dental treatment of a particular patient

or animal treatment shall keep and maintain aregister to be called the Prescription RegisterFor Psychotropic Substances and shall


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Keeping and maintenance of

Register

Separate registeror a separate part of the registerwith respect to each type of psychotropicsubstance

Enterin the register every quantity ofpsychotropic

substance received by him, name and address ofsupplier, date on which the psychotropic substancewas supplied

No cancellation, obliteration, or alteration of an entry correction must be made by way of a marginal

note or footnote, must specify date of correction Entry in chronological order Shall keep registerin premises where supply of

psychotropic substances is done.


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Form of register

Form of a bound book or in the form which

has the written approval of the licensing

officer(State Director of Health)

Must be kept fortwo years from the date of

the last entry in such register


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Storage of Psychotropic

Substances

Regulation 24 Poisons (PsychotropicSubstances) Regulations 1989

Psychotropic substances must be kept in a

room, cabinet, safe or receptacle which shallremain locked

It may only be opened to

Carry out sale / supply of psychotropicsubstances as dispensed medicine Keep psychotropic substances Conduct stock check of psychotropic substances


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Stock check of psychotropic

substances

Physical stock must be the same with that

ofbalance in records

Balance for each type of psychotropic

substances must be stated in the Register

Additional requirement for Register: Add in a

column for the balance of psychotropic

substances


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Summary Psychotropic Records

Register must be in a bound book form and kept inpremises

One item one register / separate part of register Register must be kept for 2 yrs since last entry

Requirements of record Date and serial number Name and strength Name and address of patient

Quantity sold or supplied / quantity received Balance

Stock check must be done Psychotropic items must be dispensed by doctor

Pyschotropic items must be kept under lock and key


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Checklist Part III

Psychotropic items dispensed by staff

Psychotropic items not kept under lock and

key

Psychotropic records in computer form, not

bound book form, some not printed out


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Checklist Part IV

Stock check done, amount stated in records

(balance) and physical stock not tally

Stock check incomplete

Impression: Some doctors have never heard

of a stock check or doctors have never done

a stock check before


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Dangerous Drugs

Regulation 25 of the Dangerous Drugs

Regulations 1952 states:

The Dangerous Drugs Regulations 1952

does not apply to products containing

drugs as listed in the Third Schedule of the

Regulations except

Paragraph (8) of Regulation 15 and Regulation 16


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Paragraph (8) of Regulation 15

Any registered pharmacist who

manufactures any product, or compounds

any preparation containing any drug, shall

enter in the Register true particulars withrespect to every drug used by him in

manufacturing or compounding such product

or preparation, respectively


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Regulation 16

(1) All registers, books, records etc. are to be

preserved for2 years since the last entry

(2) Any person failing to comply with the

requirements of this Regulation shall be guilty

of an offence against the Ordinance and

liable to a fine not exceeding two thousand

ringgit


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Dangerous Drugs

Poison Act 1952 applies to drugs listed in

no. 1 of the 3rd schedule

Poisons (Psychotropic Substances)

Regulations 1989 applies to drugs listed in

no. 2 of the 3rd schedule


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Checklist Part V, Question 1

Are you dealing with dangerous drugs?

Meaning other substances not listed in the

Third Schedule of Dangerous Drugs

Regulations1952

Orraw materials(not products) of drugs

listed in the Third Schedule


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Labeling Discrepancies

No proper labeling of dispensed medicine

No name of medicine

No label controlled medicine or ubatterkawal


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Labeling Requirements

Regulations 12 Poisons Regulations 1952

and Regulations 28 Poisons (Psychotropic

Substances) Regulations 1989 Name and address of supplier / seller

Name of patient / purchaser

Name of medicine

Adequate directions for use Date of dispensing

Serial number of entry into records


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Labeling Requirements

Paragraph (2) of Regulations 12

Controlled Medicines or Ubat Terkawal

Paragraph (3) of Regulations 12 Not to be Taken or For External Use Only

in English, Malay, Chinese and Tamil printed

in red or on a red background


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Checklist Part V Question 2

No serial number

No words controlled medicine or ubat

terkawal


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Conclusion

The Checklist will inform private practitioners

why and for what purpose enforcement

officers do inspections and

What to expect from them to comply with our

laws and regulations


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Thank you

ms chai's presentation "checklist on self-inspection of private clinics"

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