The public debate that followed the tabling of the Poisons Act Amendment 2019 Bill raised the issue of prescription and dispensing by doctors, which has been a recurrent theme of some pharmacists.
Prescription is part and parcel of medical practice.
The World Health Organization’s definition of a prescription “is an instruction from a prescriber to a dispenser. The prescriber is not always a doctor but can also be a paramedical worker, such as a medical assistant, a midwife or a nurse. The dispenser is not always a pharmacist, but can be a pharmacy technician, an assistant or a nurse.
“Every country has its own standards for the minimum information required for a prescription, and its own laws and regulations to define which drugs require a prescription and who is entitled to write it. Many countries have separate regulations for opiate prescriptions.”
The Malaysian Medical Council (MMC) states that “Dispense” or “dispensing” means the interpretation of a prescription or order for a drug, biological, or device and, pursuant to that prescription or order, the proper selection, measuring, compounding, labelling, or packaging necessary to prepare that prescription or order for delivery or administration.”
It implies that an effective form of the correct medicine is delivered to the right patient, in the correct dosage and quantity, with clear instruction(s), and in a package that maintains the potency of the medicine.
Dispensing includes all the activities that occur between the time the prescription is made and the time the medicine or other prescribed items are issued to the patient.
There are various laws that govern dispensing. They include the Medical Act, Private Healthcare Facilities and Services Act, Poisons Act, Sale of Drugs Act, Dangerous Drugs Act, Medicines (Advertisement and Sale) Act, Drug Dependence (Treatment and Rehabilitation) Act and the regulations of these Acts.
The doctors’ right to dispense is provided by the Poisons Act and the Private Healthcare Facilities and Services Act and their regulations.
Section 19 (1) of the Poisons Act states “Any poison other than a Group A Poison may be sold, supplied or administered by the following persons for the following purposes —
(a) a registered medical practitioner may sell, supply or administer such poison to his patient for the purposes of the medical treatment of such patient only”
Section 21(1)(b) of the Poisons Act states “Group B Poison shall not be sold or supplied by retail to any person except by a registered medical practitioner, registered dentist, Division I or veterinary officer selling or supplying the same in accordance with section 19.”
Part XI of the Private Healthcare Facilities and Services (Private Medical Clinics or Private Dental Clinics) Regulations 2006 contains detailed provisions (Sections 76-88) for dispensing. The provisions include the responsibilities of the head of pharmaceutical services, staffing, location, facilities, labelling of medications, expired or discontinued drugs, contaminated medications, cold chain, storage of vaccines, and policies.
Good Dispensing Practice
The title of the Medical Act states “An Act to consolidate and amend the law relating to the registration of medical practitioners, the control and regulation of the practice of medicine, to provide for certain provisions with regard to a period of service in the public services after full registration as a medical practitioner; and to make provisions for matters connected thereto.”
Section 4A of the Medical Act states: “(1) The Council shall have the power to do all things expedient or reasonably necessary for or incidental to the carrying out of its functions under this Act. (emphasis added)
(2) Without prejudice to the generality of subsection (1), the powers of the Council shall include power to:
(a) ensure that the provisions of this Act and the regulations are administered, enforced, given effect to, carried out and complied with;
(b) regulate the standards of practice of registered medical practitioners;
(c) regulate the professional conduct and ethics of registered medical practitioners;…”
In accordance with its statutory duties, the MMC issued its Guidelines for Good Dispensing Practice on 19 July 2016.
Doctors who do not comply with the MMC’s Code of Professional Conduct, guidelines and directives expose themselves to disciplinary action by the MMC.
Prescription And Dispensing
Sections 3.1 and 3.2 of the MMC’s Guidelines for Good Dispensing Practice addresses the issue of some patients’ requests for prescription(s) from the doctor for dispensing at a pharmacy.
Section 3.1 states “In all registered medical clinics with pharmaceutical facilities, it is recommended that a notice be displayed in a prominent area of the registration counter to inform patients that that the clinic has a dispensing facility and that patients that patients have the choice to have their medication/drugs dispensed at the clinic or at any pharmacy.”
Section 3.2 states “Patients who do not wish to have their medication/drugs dispensed in the clinic should request to indicate so at the time of their registration and will be provided with a written or printed prescription when requested.”
There is no published data on the incidence of requests by patients for prescriptions from doctors for their medicines to be dispensed by a pharmacist and the incidence of refusals by doctors to provide the requested prescription(s).
The Poisons Act Amendment 2019 Bill, tabled for first reading at the House of Representatives on 25 November 2019, was subsequently not tabled for the second reading.
The proposed Section 19(2A) in the Bill made it a statutory requirement for a doctor, dentist or veterinarian to provide a prescription upon request. Failure to do so would, upon conviction, leads to a fine not exceeding RM50,000, imprisonment not exceeding 5 years or both.
The proposed Section 19(2A) usurps the Medical Act which controls and regulates the practice of Medicine and the Dental Act which regulates the practice of dentists.
There is no provision in the Poisons Act for encroachment on the professional autonomy of the medical and dental professions provided in the Medical and Dental Acts.Dr Milton Lum, Past President of the Federation of Private Medical Practitioners Associations, Malaysia and the Malaysian Medical Association
Furthermore, there is no other country in the world known to criminalise a refusal to provide a prescription upon request as provided in the proposed Section 19(4)(b).
The phrasing of the proposed Section 19(2A) does not protect patients who request for prescriptions when there is no clinical indication, for example, requests for psychotropic drugs, sleeping pills, antibiotics, or self-administered abortion pills, thereby opening up a Pandora’s box of interpretation abuse, threats to doctors and dentists, blackmail and even corruption.
Such a sledgehammer approach without any sense of proportionality is a reflection of the lack of understanding and consideration of the legal and ethical matrix of prescription and dispensing.
In any case, any patient in Malaysia has a right to consult any registered doctor or dentist. If there is refusal to provide a prescription upon request, the patient can always consult another doctor or dentist who does; complain to the MMC or Malaysian Dental Council; or complain to the Health Ministry under the Private Healthcare Facilities and Services Act.
Dr Milton Lum is a past President of the Federation of Private Medical Practitioners Associations, Malaysia and the Malaysian Medical Association. This article is not intended to replace, dictate or define evaluation by a qualified doctor. The views expressed do not represent that of any organization the writer is associated with.
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