New Pharmacovigilance Course at the International Islamic University Malaysia-IIUM

To the Editor. The Malaysian Adverse Drug Reactions Advisory Committee (MADRAC) was established under the Drug Control Authority (DCA) to perform the function of pharmacovigilance for drugs registered for use in Malaysia. It became a member of the World Health Organization (WHO) Program for International Drug Monitoring in 1990.¹ Although MADRAC has invited healthcare professionals (physicians, pharmacists, dentists, etc) to submit adverse drug reaction (ADR) reports, the number of ADR reports submitted by healthcare professionals is considered low according to WHO recommendations for the optimal National Pharmacovigilance Centre.² The most important reason for underreporting of ADR by healthcare professional is a lack of information³.

As healthcare professionals and drug experts, pharmacists can play a crucial role in preventing ADRs and medication errors, improving patient satisfaction and quality of life, and improving economic outcomes.^{4, 5} There are about 17 pharmacy schools (public and private) in Malaysia and 10 are fully accredited⁶. Many of the schools do not have enough education courses regarding pharmacovigilance. These deficiencies in pharmacovigilance education and training in colleges and schools of pharmacy may contribute to underreporting in Malaysia⁷.

A pharmacovigilance course was introduced at the Kulliyyah of Pharmacy-International Islamic University Malaysia during the current academic year (2012-2013). The course was offered as a part of the Research in Pharmacy-Biostatistic & Pharmacoepidemialogy module during the first semester for third-year students enrolled in the bachelor of pharmacy degree program.

The pharmacovigilance course consists of 7 hours of lecture, 1 hour of practical (ADR report writing), 1 hour of small groups case discussions and presentations, and 1 hour of written homework assignments. The lectures covere many topics related to pharmacovigilance: clinical aspects of ADRs, importance of ADR reporting and documentation, epidemiology of ADRs, terminology and definitions in pharmacovigilance and ADRs, vaccines pharmacovigilance and classification of adverse events following immunization, causality assessment types, pharmacovigilance methods, clinical trials and cost, the Malaysian National Pharmacovigilance System, and involvement of pharmacists in pharmacovigilance activities. At the end of the pharmacovigilance course, questionnaires are administered to students to assess their perceptions and knowledge about pharmacovigilance.

As lecturers and researchers, we believe that it is time for all pharmacy colleges and schools to help pharmacovigilance systems to reach the pharmacovigilance goals of the WHO through educating future generations of pharmacists and all health care providers. Pharmacy colleges and schools have the responsibility to improve pharmacovigilance education and to develop the practice skills of undergraduate pharmacy students. Although the initiation of the new course requires additional resources and takes time to develop and update the curriculum, we strongly advise others Malaysian schools of pharmacy to mandate a pharmacovigilance course and training as part of their core curriculum.

• © 2013 American Association of Colleges of Pharmacy