Analysis of under-reporting of Adverse Drug Reaction: Scenario in India and neighbouring countries

Adverse Drug Reaction (ADR) is a noxious and unintended response to a medicine which occurs at doses normally used in human being. Pharmacovigilance (PV) is the process to monitor patient safety in practical condition and analyse adverse events during the entire life cycle of a drug beginning from its trial phase to post-marketing of the drug. Before medicines get authorised, they are tested in controlled trial conditions within a smaller population for a limited length of time. Post authorization, drugs are used by a larger population across various geographies without any control in place. So, it is very important to monitor adverse effect caused by these medicines throughout their life cycle in order to identify and minimize risks associated with the use of drug and enhance the knowledge of healthcare professionals. Under reporting is a major obstacle in the PV system. Research shows that the major causes of under reporting are lack of knowledge and awareness among healthcare professionals and also absence of established ADR reporting system in various part of the world. Some other reasons of under-reporting included large number of patients, lower doctor-patient ratio and common practice of self-medication. This article reviews the research done on ADR under-reporting scenario with a focus on the factors leading to this obstacle in PV. Keywords: ADRAdverse Drug Reaction, PVPharmacovigilance, WHOWorld Health Organisation, UMCUppsala Monitoring Centre, AMCADRs Monitoring Centres, AIIMSAll India Institute of Medical, Sciences, CDSCOCentral Drugs Standard, Control Organization, ICSR Individual Case Safety Report, FDA Food and Drug administration, ICH International Conference on Harmonisation, EMAEuropean Medicines Agency, PRAC Pharmacovigilance Risk, Assessment Committee, PMDA Pharmaceuticals and medical, Device Agency.