Various aspects of the proposed Pharmacy Bill, particularly its governance mechanisms and its impact on medical and dental practice, need to be clarified.
There has been much public discussion about the issue of dispensing separation. This arose from the proposed Pharmacy Bill, which has been mentioned considerably less.
There is some information about the Bill, which is in the public domain (Source: mps.org.my) in the online engagement by the Pharmaceutical Services Division of the Health Ministry.
Several issues require consideration.
Omnibus Bill
The proposed Pharmacy Bill is an omnibus Bill to replace four Acts, i.e. Registration of Pharmacists. Poisons Act, Sale of Drugs Act and the Medicines (Advertisement and Sale) Act.
The Registration of Pharmacists Act relates to the establishment of a Pharmacy Board and the registration of pharmacists.
The Pharmacy Board comprises the Director General of Health; the Director of Pharmaceutical Services; as well as registered pharmacists in the public service, from any higher educational institution offering courses in pharmacy, not in the public service and nominees by the association representing pharmacists in private practice.
All appointments are made by the Health Minister.
The Poisons Act regulates the importation, possession, manufacture, compounding, storage, transport, sale and use of poisons by doctors, dentists, veterinarians, manufacturers, distributors and retail outlets.
The Poisons Board comprises the Director General of Health; Director of Pharmaceutical Services; nominees of the Department of Chemistry, Department of Agriculture and Veterinary Department; and one nominee of the Malaysian Medical Council, Malaysian Medical Association, the four Malaysian Chambers of Commerce and Industry, Malaysian Pharmaceutical Association, and Malaysian Rubber Producers Council.
All appointments are made by the Health Minister.
The Poisons Board advises the Minister on the scheduling of poisons. Scheduling is a classification system that controls how medicines and poisons are made available to the public.
Medicines and poisons are classified into Schedules according to the level of regulatory control over the availability of the medicine or poison, required to protect public health and safety.
Currently, there are three schedules. Part I poisons are grouped into Groups A to F. Group A poisons cannot be used in humans and its use is limited to other trades or scientific research.
Group B poisons require prescriptions by doctors, dentists or veterinarians.
Group C poisons can be sold by a pharmacist with the details of the purchasers and medicines recorded.
Group D poisons can only be sold by a pharmacist to a person known personally to him or introduced to him personally by another person known to him.
Part II poisons are used in industries or trades that do not involve consumption as a medicine. It also contains consumable and surgical articles and preparations.
Part III poisons are psychotropic substances.
The Sale of Drugs Act regulates the sales of drugs.
The Medicines (Advertisement & Sales) Act regulates advertisements relating to certain diseases, abortion and skill or service; approvals for advertisements of medicines; and disclosure of the composition of medicines.
Pharmacy Bill
The Pharmacy Bill provides for the establishment of a Pharmacy Council, with the Senior Director of Pharmaceutical Services as Chairman and 16 pharmacists. Its function is to “maintain the registration of pharmacists and disciplinary actions, to commence registration of pharmacy assistants (involving more than 6,000 pharmacy assistants, of whom more than 50% works with MOH) and to ensure the quality of pharmacy degree/diploma graduates from all approved higher learning institutions.”
The Pharmacy Bill also provides for the Senior Director of Pharmaceutical Services to be the Competent Authority, i.e. the person invested with legal power.
The Director may delegate power to officers in the Pharmaceutical Services in the execution of provisions in the Act in respect of “New Control on Medicinal Products and Licensing”.
The former involves the “classification and registration of medicinal products on the recommendation of the Medicinal Product Evaluation Committee”, and the latter “new registration of all pharmacy premises”, “new licence for clinical trials” and “new licence for industrial consumers and professionals”.
The current Poisons Board is replaced by the Medicinal Product Evaluation Committee (MPEC) in the Pharmacy Bill.
It comprises a pharmacist appointed as Chairman by the Senior Director of Pharmaceutical Services; 21 pharmacists as permanent members; and six associate members who have “relevant expertise, medical specialist qualifications or experience in medicine or pharmaceutical science or veterinary medicine and consisting of at least one pharmacist in the private sector specialising in the manufacture of products, one toxicology expert and one registered veterinary surgeon”.
The associate members have no voting rights.
The function of the MPEC is to “make recommendations to the Competent Authority for the purpose of classification, registration of medicinal products, medicaments and to assess the medicinal product claims before being registered”.
The current Poisons Schedule will be replaced by three categories of medicines.
• Prescription only Medicines (“POM”) are “psychotropic medicinal products; narcotic medicinal products; medicinal products formerly Group B Poisons”.
• Pharmacist only Medicinal Products/Substances (“POMP”) are “psychotropic active substances/precursors formerly Group B/C poisons” and “medicinal products which can be obtained from registered pharmacists without a prescription – formerly Group C Poisons (finished products for dispensing containing antihistamine, pholcodine, antidiabetics, external preparations containing an antibiotic/steroid)”.
• General Sales List (“GSL”) are “materials available from the industry/special use for precursor materials, acid and alkaline solvents; and registered products such as traditional medicines, supplements or cosmetics with notification which are available over-the-counter”.
There will be de facto dispensing separation as POM medicines can only be dispensed by pharmacists upon prescriptions from doctors, dentists or veterinarians.
Pertinent questions
The Health Ministry’s silence on the various aspects of the Pharmacy Bill, particularly its governance mechanisms and its impact on medical and dental practice, has been deafening.
Some of the questions, which are not exclusive, include:
• What is the rationale for including the Registration of Pharmacists Act with the Poisons Act, Sale of Drugs Act, and the Medicines (Advertisement and Sale) Act, thereby creating an omnibus Bill?
This is akin to having an omnibus Bill that comprises the Medical Act or Dental Act, and other Acts related to medical or dental practice.
• What is the rationale for the disbandment of the Poisons Board, in which all stakeholders are represented?
• What is the rationale for replacing the Poisons Board with the Medicinal Product Evaluation Committee, which comprises only pharmacists as permanent members?
• What assurance is there that the Medicinal Product Evaluation Committee will perform better than the current Poisons Board in advising the Senior Director of Pharmaceutical Services and the Health Minister on the sale and use of poisons by doctors, dentists veterinarians, manufacturers, distributors and retail outlets?
• Is there any conflict with the Competitions Act as the pharmacists are the only permanent members of the Medicinal Product Evaluation Committee?
• Why is legal authority vested in the Senior Director of Pharmaceutical Services and not the Director General of Health?
• What functions would be delegated by the Senior Director of Pharmaceutical Services?
• What would be the impact of putting “psychotropic active substances/precursors formerly Group B poisons” in the Pharmacists only Medicinal Products/Substances list on the prevention and control of drug addiction in the country?
• Who will be legally responsible if patients cannot obtain prescribed medicines in a timely manner because of dispensing separation, especially if they suffer adverse consequences?
With the limited information about the Pharmacy Bill in the public domain, there are already many unanswered questions. As such, it is inevitable that there are legitimate questions as to whether there are other radical changes in the undisclosed sections of the Bill.
The Health Ministry’s duty must surely be to put patients’ rights and continuity of care first, and not that of doctors, dentists, veterinarians, pharmacists or commercial organisations that have bought up or established numerous pharmacies with the expectation of dispensing separation (Source: theedgemarkets.com)
With the vesting of the regulation of medicines and poisons in an individual and/or a single profession in the Pharmacy Bill, it is necessary for the Health Ministry to heed William Pitt’s statement in 1770, i.e. “Unlimited power is apt to corrupt the minds of those who possess it”, which is as applicable today as it was then.
¦ Dr Milton Lum is a member of the board of Medical Defence Malaysia. This article is not intended to replace, dictate or define evaluation by a qualified doctor. For further information, e-mail starhealth@thestar.com.my. The information provided is for educational and communication purposes only. The Star disclaims all responsibility for any losses, damage to property or personal injury suffered directly or indirectly from reliance on such information.
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