Regulatory Matters:
Public sector and private sector pharmacists in Malaysia have worked under different legislative environments since 1952. Malaysian pharmacy legislations have granted public pharmacists exclusive medicine dispensing rights while the private pharmacists do not enjoy the same right! This discrepancy has been there for the past 50 years. It has created many heartaches and problems for the private community pharmacists especially when the legislation has double-standard and is further interpreted in a biased way.
Most of the community pharmacies, which are owned and operated by pharmacists, are reasonably small establishments that lack resources to promote and protect their interests in the past. MCPA should have a closer look at the present Pharmacy Legislation, which regulate the pharmacy practitioners, and make official presentations and negotiation with the government on any issue of concern.
Some of the legislative discrepancies and problems are highlighted below with the hope of “gaining government’s attention” to rectify the situation:
Case 1:
For the supply of Poisons, other than Psychotropic Substances and Dangerous Drugs, from a private clinic or a private hospital, the only applicable legislation is found in Poisons Regulations 1952 regulations (24), and (25).
The legal provision that applies to In-Patients, where a signed written-order is required, only requires the container of poison “be labeled with the words describing its contents”. There is no legal requirement for adequate instruction of the use and doses, no patient’s name needs to be affixed to the container, and there is no mention of the drug’s quantity and the date of supply.
As to the out-patients from a private clinic or a private hospital, there is no legal requirement “to provide instructions on doses, drug’s quantity, patient’s name, and date of supply”. The latest legal requirements added on 1st January 2004 (that requires the label to contain the name of medicine, and the word “Controlled Medicine” or “Ubat Terkawal”) is a classic example of “in coordinated piece-meal legislative amendment that does not examine and address the problem more satisfactorily.”
Case 2:
For Psychotropic Substances, there is serious ambiguity in Regulations (11) and (17) of the Poisons (Psychotropic Substances) Regulations 1989. Regulation (17) only permits pharmacists (in private and public sectors) to dispense psychotropic substances. But Regulation (11) permits a registered medical practitioner to sell and supply psychotropic substances to his patients.
The question to ask is this, “Is a medical doctor legally permitted to dispense a psychotropic substance?” Regulation (17) clearly did not permit a doctor to dispense any psychotropic substance to his own patients.
The next question to ask is this, “ What about Regulation (11) that allows a doctor to sell and supply?”
To find an acceptable interpretation to resolve the conflict, one needs to contextualise them with Regulation (16). It becomes clear that Regulation (11) “”sell and supply” allows a doctor to administer the medicine to the patient and charge for the same. Therefore, any supply other than for doctor’s immediate administration to his own patients appears to be illegal.
This legal interpretation is further supported by Section (30) of the (principal Act) Poisons Act 1952, which categorically states that regulatory control over the psychotropic substance is independent from other “Poisons”. Therefore, it is not against the spirit of Poisons Act 1952 to accept the interpretation that a doctor cannot dispense to his own patients any psychotropic substance.
Case 3:
If one takes the view (continues the argument from Case 2 above) that a registered medical practitioner is allowed to dispense psychotropic substances to his own patients, then he must write a valid prescription for each and every patient. After dispensing, he must enter or cause it to enter into the Prescription Register For Psychotropic Substances according to the Regulations, exactly the same as a private sector community pharmacist. He has to comply with Regulations (11), (19), (20), (22), (24), (25), and (28) in prescribing, dispensing, storage, disposable, entering and maintaining a proper register.
The recording into a Prescription Register For Psychotropic Substances has not been complied with by perhaps all the medical doctors. They usually only enter the record into a “Day-Book”.
Secondly, probably all the private doctors, other than those attached to the big private hospitals where they employ a pharmacist, do not write a valid prescription for their own patients. This is another serious breach of the pharmacy legislation.
Case 4:
Poisons Act 1952, Section (26) deals with a few types of licenses pertaining to the handling of all the scheduled poisons (drugs). This section should, by normal legal understanding, regulate only the terms and conditions of these licenses, which would imply the eligibility of the license applicants and holders. Only ‘fit and proper person’ will be issued the license.
But, for the past 20 years, many States Licensing Officers had resorted to sub-section (4) of Section (26) (mentioned above) “as a blanket authorization to implement any administrative matters such as additional documentation or recording for certain drugs.” Other more appropriate sections of a suitable Act should be used. Section (26) does not have any legal authority over these administrative matters or documentation. This is a matter of great concern to the profession.
The delegated authority, granted under Section (26) of Poisons Act 1952, should not be further abused or incorrectly interpreted by the officers.