Pharmacovigilance in India and five ASEAN countries (Malaysia, Singapore, Thailand, Indonesia, Philippines): A comparison study

Abstract

The World Health Organization (WHO) defines PV as the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other possible drug-related problems (WHO 2004). In 1968, during the 16th World Assembly the 16.36 resolution called for "a systematic collection of information on serious adverse drug reactions during the development and particularly after medicines have been made available for public use". This led to the formation of the WHO Programme for International Drug Monitoring (PIDM) in 1968. PV systems should include all entities and resources that protect the public from medicines-related harm (adverse reactions, poor product quality, medication errors, and therapeutic ineffectiveness), whether in personal healthcare or public health services. The PV system safeguards the public through efficient and timely identification, collection, and assessment of medicine-related adverse events and by communicating risks and benefits. The WHO has provided technical and normative leadership on PV since the development of the first voluntary notification scheme in 1961. As of January 2016, 123 countries have joined the WHO PIDM, and in addition 28 associate members are awaiting full membership. WHO has defined norms and guidelines for PV and has allowed information sharing among the participant countries. Another WHO PV-related activity is the work of the Council for International Organizations of Medical Sciences (CIOMS) which was established jointly by WHO and UNESCO in 1949. Starting with the publication of the Suspect Adverse Reaction Report Form (CIOMS Form I) by the CIOMS working group II, other CIOMS publications have greatly shaped the direction of PV. CIOMS publications have also greatly influenced the development of International Conference on Harmonization of Technical requirements for Registration of Pharmaceuticals for Human Use (ICH) E2A-E2F guidelines in drug safety. The standards for the electronic transmission of regulatory information regarding the individual case safety report (ICSR) has been changing over the last decade. The ICH adopted the E2B (R2) in February 2001 and the E2B (R3) in 2005, is being developed as the proposed harmonized international standards for health products safety reporting. These ICH guidelines have facilitated the adoption of harmonized standards for PV activities. This study contributes to filling the gap in the understanding of the PV systems capacity in Indian and five ASEAN countries namely Malaysia,