Ms Chai's Presentation "checklist On Self-inspection Of Private Clinics"

Checklist on SelfInspection of Private Clinics By: Cawangan Penguatkuasa Farmasi Sarawak

What is the Checklist on SelfInspection 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  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

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