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,\xa0assessment, understanding, and prevention of adverse effects or any other possible drug-related problems\xa0 (WHO 2004). In 1968, during the 16th World Assembly the 16.36 resolution called for “a systematic\xa0collection of information on serious adverse drug reactions during the development and particularly after\xa0medicines have been made available for public use”. This led to the formation of the WHO Programme\xa0for International Drug Monitoring (PIDM) in 1968. PV systems should include all entities and resources\nthat protect the public from medicines-related harm (adverse reactions, poor product quality, medication\xa0errors, and therapeutic ineffectiveness), whether in personal healthcare or public health services. The\xa0PV system safeguards the public through efficient and timely identification, collection, and assessment\xa0of medicine-related adverse events and by communicating risks and benefits. The WHO has provided\xa0technical and normative leadership on PV since the development of the first voluntary notification scheme\nin 1961. As of January 2016, 123 countries have joined the WHO PIDM, and in addition 28 associate\xa0members are awaiting full membership. WHO has defined norms and guidelines for PV and has allowed\xa0information sharing among the participant countries. Another WHO PV-related activity is the work of\xa0the Council for International Organizations of Medical Sciences (CIOMS) which was established jointly\xa0by WHO and UNESCO in 1949. Starting with the publication of the Suspect Adverse Reaction Report\nForm (CIOMS Form I) by the CIOMS working group II, other CIOMS publications have greatly shaped\xa0the direction of PV. CIOMS publications have also greatly influenced the development of International\xa0Conference on Harmonization of Technical requirements for Registration of Pharmaceuticals for Human\xa0Use (ICH) E2A-E2F guidelines in drug safety. The standard