PHARMACOVIGILANCE/REPORTING ADVERSE DRUG REACTIONS: AN APPROACH TO ENHANCE HEALTH SURVEILLANCE AND EXTENDING MARKET SHARE BY MINIMIZING THE CHANCES OF DRUG WITHDRAWALS

Abstract

Any unintended response of a drug which; apart from the doses that cover therapy of a disease; includes lack of efficacy, overdose and its misuse can be termed as an adverse drug reaction. In this scenario, adverse effects of drugs are mostly shown which result in the withdrawals of block buster's molecules and finally lead to the sharp decline of the market share. So there is an immense need to keep a hawk eye on these suspected adverse reactions to enhance health surveillance as well as minimizing the chances of drug withdrawals from the market. Thus the whole exercise of reporting adverse drug reactions is administered through implementation of pharmacovigilance program that deals with timely identification of ADR and it's monitoring-i.e. Collecting data, assessment, and follow up action. The importance of Pharmacovigilance has been on the rise because the frequency of ADRs and the percentage of hospital admissions have been increasing day by day, which finally have led to decline the global market share of blockbuster drugs by numeral instances of the cases of recalls and in some more severity have resulted in drug related mortality and morbidity of patients forcing the companies to ultimately withdraw the drug. The article highlights the different approaches of reporting the adverse drug reactions for enhancing the health surveillance and strategic consent for the pharmaceutical industry to generate long term revenues by reducing the chances of drug withdrawals with special emphasis on the consequences of reporting and non-reporting of ADRs and due examples of drug reported ADRs & their recalls. The article also highlights the Pharmacovigilance program in the European Union, United States and India, strategies for reducing the ADRs and future aspect of Pharmacovigilance.