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Checklist on Self-

Inspection of Private
Clinics
By: Cawangan Penguatkuasa
Farmasi Sarawak
What is the Checklist on Self-
Inspection of Private Clinics
Guide:
 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
How is the Checklist
regulated?
 Checklist – sent to all private clinics
 To be filled and returned to the Pharmacy
Enforcement department within a month of
receiving the checklist
 Clinic inspections will still be carried out
 Necessary action will be taken should any aspect
of the law is compromised or violated
Why the Checklist?
 Based on the clinic inspection reports, there
are still many discrepancies in the recording
of dispensed medicine in private clinics
 Statistics – Kuching: 34% of clinics inspected
do not have proper recording
 Outstation: 45 – 80% of clinics do not have
proper recording
Why recording of Dispensed
Medicine is required?
Provisions of recording stated under:
 Poisons Act 1952

 Poisons Regulations 1952

 Poisons (Psychotropic Substances)


Regulations 1989
 Dangerous Drugs Act 1952

 Dangerous Drugs Regulations 1952


Recording of Dispensed
Medicine
 Prescription book for sale and supply of
poisons as a dispensed medicine
 Prescription Register for Psychotropic
Substances for the sale and supply of
psychotropic substances as dispensed
medicine
Discrepancies in Recording –
Prescription book
Prescription book (S24 PA 1952)
 No prescription book
 Doctor rely only on patient card
 Not updated
 Prescription book in computer form (soft
copy) Not printed out – information can be
easily manipulated.
 Doctor reluctant to print out prescription book
 Too much paperwork
Prescription book
 Poisons Act 1952
 ‘Poisons’ are as listed in the First Schedule

 S24 PA 1952 states that the sale / supply of a


poison 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
Format of the prescription
book
 Date of sale / supply of medicine and the
serial number of 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


Checklist – Part II
 Most Prescription Books do not have the
patient’s serial number
 Requirements of the law – serial number (if
any)
 Prescription Book in computer form – not
printed
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
Discrepancies in Recording –
Psychotropic substances
 Psychotropic substances not kept under lock
and key
 Staff instead of doctor dispensing
psychotropic substances
Psychotropic substances
 Psychotropic substance: as specified in the
Third 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 of
medical or dental treatment of a particular patient
or animal treatment shall keep and maintain a
register to be called the “Prescription Register
For Psychotropic Substances” and shall
Prescription Register for
Psychotropic Substance
 On the day such psychotropic substance
is sold or supplied or administered, enter
or cause to be entered therein particulars
with respect to-
 The date of supply and the serial number to the
entry into the register
 The name and strength of psychotropic
substance
 Quantity sold / supplied
 The name and and address of the patient
Keeping and maintenance of
Register
 Separate register or a separate part of the register
with respect to each type of psychotropic
substance
 Enter in the register every quantity of psychotropic
substance received by him, name and address of
supplier, date on which the psychotropic substance
was 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 register in premises where supply of
psychotropic substances is done.
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 for two years from the date of
the last entry in such register
Storage of Psychotropic
Substances
 Regulation 24 Poisons (Psychotropic
Substances) Regulations 1989
 Psychotropic substances must be kept in a
room, cabinet, safe or receptacle which shall
remain locked
 It may only be opened to
 Carry out sale / supply of psychotropic
substances as dispensed medicine
 Keep psychotropic substances
 Conduct stock check of psychotropic substances
Stock check of psychotropic
substances
 Physical stock must be the same with that
of balance 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
Summary – Psychotropic Records
 Register must be in a bound book form and kept in
premises
 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
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
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
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
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 with
respect to every drug used by him in
manufacturing or compounding such product
or preparation, respectively
Regulation 16
 (1) All registers, books, records etc. are to be
preserved for 2 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
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
Checklist – Part V, Question 1
 Are you dealing with dangerous drugs?
 Meaning other substances not listed in the
Third Schedule of Dangerous Drugs
Regulations1952
 Or raw materials (not products) of drugs
listed in the Third Schedule
Labeling Discrepancies
No proper labeling of dispensed medicine
 No name of medicine

 No label ‘controlled medicine’ or ‘ubat


terkawal’
Labeling Requirements
 Regulations12 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
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
Checklist – Part V Question 2
 No serial number
 No words ‘controlled medicine’ or ‘ubat
terkawal’
Checklist – Part V Question 3
 Are medicines allowed to be dispensed to the
patient without the patient seeing the doctor?
 No.
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
Thank you