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Difference between OTC and controlled medicines
Published on: Sunday, August 20, 2017
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By Malaysian Pharmaceutical Society
WE refer to your report to allow clinics to dispense OTC Medicine.

The term Over-The-Counter (OTC) medicine is defined as medicines that are not controlled under the Poisons Act 1952. Examples of OTC medicines are non-poison cough preparations, sore throat preparations, anti-diarrhoeal preparations and laxatives, amongst others. These types of medicines are available in department stores, convenience stores, clinics and pharmacies, and sundry shops.

Medicines controlled under the Poisons Act 1952 are classified into two types namely Group B and Group C medicines and can be provided to patients with certain restrictions unlike the Over-The-Counter medicines.

Group B medicines are strictly to be dispensed upon prescription by doctors. Group C medications can be dispensed by pharmacists without any prescription after consultation with the patient, or by doctors themselves after examining the patient.

Pharmacists are well versed in the pharmacological effects of medicines as it is the core subject of their degree.

To ensure safety, the law requires that medicines in Group B and C to be dispensed either personally, or under the direct supervision of doctors or pharmacists. Every patient deserves to be examined or seen by the relevant healthcare professional before being given any medicine to prevent any harm to the patient.

There are strict rules to the supply of medicines in clinics and pharmacies. Only pharmacists with a Type A licence are allowed to sell medicines by retail to patients. As per Malaysian law, only board registered pharmacists can apply for the Poison A license which gives them the right to provide medicine by retail.

Unfortunately, in this country where there is no separation of dispensing from prescribing at the private community level sector, which has shown to provide additional patient safety worldwide.

The Poison Act 1952 do give doctors the full freedom to dispense medication by themselves after examining a patient. However, they do not have the freedom to supply medicines by retail from their clinics without providing consultation to the patient first. This legislation is in place to prevent harm to the person seeking treatment.

The Pharmacy Enforcement Division of the Ministry of Health monitors and takes action against any establishment including clinics, pharmacies and traditional medicine facilities if they do not comply to the Poisons Act 1952.

The Enforcement Officers perform their duties within their scope of authority in ensuring the safety of the rakyat.

We hope this clarifies the difference between OTC and Controlled Medicines as well as how medicines can be supplied to patients.

Malaysian Pharmaceutical Society


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