Ms Chai's Presentation "Checklist on Self-Inspection of Private Clinics"
Transcript of 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
Psychotropic substances not kept under lock
and key
Staff instead of doctor dispensingpsychotropic substances
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Psychotropic substances
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