• November 27, 2015 at 1:24 pm

    Malaysia is a developing country located in Southeast Asia with a national
    centre for Pharmacovigilance, namely the ‘National Adverse Drug Reaction
    Monitoring Centre’ that services the entire country. Some major hospitals
    and pharmaceutical companies also operate ADR monitoring systems, but the
    national centre consolidates all of their reports. Normally, reports from
    doctors, pharmacist and dentists are completed on a voluntary basis, but
    reports from marketing authorization holders are mandatory. These
    personnel monitor drugs for human use, vaccines, biological and herbal
    remedies. 12 The National Drug Reaction (ADR) centre uses prepaid postage
    report forms or report cards that are updated every month. The national
    centre has an advisory committee that assesses the casualties reported in
    the ADRs. The Malaysian Adverse Drug Reaction Advisory Committee (MADRAC)
    was established under the Drug Control Authority (DCA) to monitor the
    safety profiles of drugs registered for use in Malaysia. MADRAC provides
    the DCA with information regarding drug safety both locally and
    internationally. The National Drug Safety Monitoring Centre, which is the
    secretariat to MADRAC, was accepted as the 30th member of the World Health
    Organization (WHO) Safety Monitoring Program in 1990. Under the monitoring
    programme, all ADR reports that are received and screened by MADRAC are
    submitted to the Uppsala Monitoring Centre in Sweden for inclusion into
    the WHO database.
    MADRAC also promotes ADR reporting in Malaysia, provides information
    and advises the DCA such that regulatory action can be taken based on ADRs
    that are received both locally and internationally. It also provides
    information to doctors, pharmacists and other health care professionals
    regarding ADRs and participates in the WHO ADR monitoring programm.
    Limitations of the current drug safety system in Malaysia
    Even though the Malaysian system and programme have been established more
    than 20 years, it still has few drawbacks.. The major weaknesses of the
    drug safety system in Malaysia are as follows:-

    1. Lack of awareness about drug safety among health professionals
    regarding pharmacovigilance.4

    2. Lack of awareness about the existence, function and purpose of national
    ADR reporting.4

    3. Difficulty of signal generation due to the lack of a national
    computerized database on the drug prescribed.5

    4. Inability to involve pharmaceutical industries in drug safety issues.4

    5. Lack of information on genetic effect, social practices and drug
    interaction and indication contra associated with drugs.4

    6. Presence of only a few reports on traditional and herbal drugs, which
    are widely used.4

    7. under reporting – major weakness of all spontaneous reporting
    systems.7

    8. No involvement of nursing staff and consumers in the ADR monitoring
    program.6

    9. Limited role of NGOs in drug safety issues.

    10. Limited role of mass media in public drug safety education.

    11. Selective reporting among healthcare professionals (reporting bias).

    12. Poor at detecting delayed ADRs.
    Ideas on how to improve the drug safety system in Malaysia
    A. Strategies to improve the drug safety system 9 in Malaysia:
    1. Enhancing, strengthening and empowering the role of the MADRAC.
    There is an urgent need to increase the ability of MADRAC to regulate
    drugs after they reach the market and to conduct long-term post marketing
    studies for all drugs available in the Malaysian market.
    MADRAC also needs to develop active new pharmacoepidemiological methods
    and tools, train new staff and increase their resources and funds to
    improve its role in the lives of healthcare professionals and public.
    2. Starting awareness programs for healthcare professionals to explain the
    importance, function and purposes of the national drug safety monitoring
    program in Malaysia. MADRAC should increase the role of health care
    professionals in this program and in particular, include nurses, community
    pharmacists and private general practitioners in the reporting of ADRs.
    This can result in increased knowledge about the harmful effects of drugs
    currently used in the country.
    3. Development of a consumer reporting program, 8 which would be
    beneficial to the existing program available in Malaysia and increase the
    information and knowledge regarding ADRs. This will allow MADRAC to
    overcome the main problem of under reporting while improving consumer
    rights, which will eventually improve the quality of life and patient
    safety in Malaysia.
    4. Strengthening the role of pharmacovigilance by developing new
    methods for risk analysis and risk management. This will strengthen the
    methods for safety surveillance and allow enhanced detection,
    understanding, prediction and prevention of ADRs.
    5. Improving communication and information flow between healthcare
    professionals and the public.
    6. Involvement of Non-Governmental Organizations (NGOs) in drug
    safety issues to utilise the important role of NGOs at the local level. In
    addition, NGO such as Consumer Association of Penang (CAP) and Federation
    of Malaysian Consumers Associations (FOMCA) have extensive experience in
    dealing with public interests. They can understand public needs and
    choices, as well as advocate for the rights of the people.
    7. The full involvement of drug industries in drug safety issues in
    Malaysia. There are 76 licensed local manufactures and 136 licensed local
    manufacturers of traditional medicine. One hundred seventy two companies
    are involved in the development and production of medicine and traditional
    medicine. However, the Pharmaceutical industry in Malaysia has little
    regard for safety monitoring. The full involvement of drug industry as key
    player in drug safety can improve pharmacovigilance in Malaysia. The
    companies should regularly report the ADRs associated with their products
    to the national center.
    8. Inclusion of providers of local and herbal medicine into the drug
    safety program in Malaysia. The national drug safety system should monitor
    and evaluates ADRs associated with herbal medicine. This is very rare, but
    in rapidly developing countries, there are local officials that offer
    these activities. There is a lack of methodological uniformity for
    identification and measurement of herbal medicines, which is widely in
    Malaysia. Moreover, there are very few ADR reports about these compounds
    in Malaysia.
    9. Increase the role of the mass media in public drug safety
    education. The media will remain a key provider of drug information and a
    key player in drug safety issues. It can also play an important role in
    educating the public about the harmful effects of drug and strengthening
    consumers’ views about medicines by having a weekly column and inviting
    healthcare professionals to contribute.
    10. Teaching pharmacovigilance. Pharmacovigilance should be taught to
    undergraduate students of Medicine, Nursing, Pharmacy and other healthcare
    related studies. Thus, these students will be aware of the program when
    they start their practices. Pharmacovigilance modules must be linked to
    courses on the rational use of medicines (RUM). The Uppsala Monitoring
    Centre (UMC), the international collaboration centre for ADR monitoring,
    has suggested a number of basic components of a pharmacovigilance course
    for pharmacologists and other healthcare personnel. Currently in Malaysia,
    education programs for Pharmacovigilance for undergraduate students are
    lacking. For example, in the School of Pharmaceutical Sciences at
    Universiti Sains Malaysia, Penang, students are given less than two hours
    of instruction regarding pharmacovigilance during their four-year Bachelor
    of Pharmacy course.