DRW Monthly
August 2007
Issue No. 9

Compliance Challenges Malaysia faces with Adverse Drug Reporting

The Drug Control Authority (DCA) within the Ministry of Health is the national regulatory body responsible for overseeing drug registration and licensing in Malaysia, as established by the Control of Drugs and Cosmetics Regulations 1984. The DCA, which is managed by a board of appointed members representing the Ministry of Health and National Pharmaceutical Control Board (NCPB), is tasked with ensuring the safety, quality and efficacy of the country's pharmaceutical products. According to the DCA, "any drug in a pharmaceutical dosage form, intended to be used, or capable or purported or claimed to be capable of being used on humans or any animals, whether internally or externally, for a medicinal purpose is required to be registered" with this authority.(1) The daily operations of drug and cosmetic registration combined with monitoring and surveillance activities are handled by the NCPB which was established in 1978 by the Ministry of Health to implement quality control measures on pharmaceutical products.

As part of the regulatory process of ensuring consumer safety for registered products, the Adverse Drug Reaction (ADR) Monitoring Program was established within the Centre for Post-Registration, one of the professional centers for which the NCPB provides oversight. Within the Centre, the Malaysian Adverse Drug Reactions Advisory Committee (MADRAC) performs the function of monitoring safety profiles of drugs registered for use in Malaysia. Under this monitoring program, all ADR reports received are screened by MADRAC before being submitted to the World Health Organization's (WHO) Collaborating Centre for Drug Safety Program in Uppsala, Sweden for inclusion in its ADR database. MADRAC members consist of health professionals appointed by the Director General of Health to study drug safety issues relating to registered products. The primary functions of MADRAC include:

• promoting ADR reporting in Malaysia
• providing information and advice to the DCA so that regulatory action can be taken based on the ADRs received in Malaysia and internationally
• supplying information to doctors, pharmacists and other health care professionals on ADRs(3)

Although the ADR Monitoring Program represents a formidable system by which registered drugs can be tracked, the challenge faced by MADRAC is in actually getting marketing authorization holders (MAHs), health care professionals and consumers to report the ADRs. Some of their challenges have been attributed to the fact that MAHs are the only ones required to report any adverse effects identified in registered drug products, whereas it is only encouraged for health professionals. This situation has been further complicated by MADRAC's failure to rigorously enforce the official guidelines. In the more recent past, MADRAC has been working with WHO's Collaborating Centre for Drug Safety Program to promote ADR reporting by distributing the Manual on ADR Reporting to medical practitioners and pharmacists; supplying reporting forms with prepaid postage freely to doctors and pharmacists; presenting talks to public and private sector doctors and pharmacists, and writing articles on ADR reports in its local newsletter.(4) It is hoped that these activities will encourage health professionals and MAHs alike to share their adverse event experiences on a more regular basis with MADRAC.

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