Highlights on Pharmacovigilance

Pharmacovigilance and all drug safety issues are pertinent for all those whose life is touched by medical intervention(s). Thus the safety alarms and chaos that resulted recurrently, commencing from thalidomide disaster, led to many painstaking initiatives by the regulatory bodies. It has been an attempt by the International Conference on Harmonization (ICH), World Health Organization (WHO) and Uppsala Monitoring Committee (UMC) to make the best of amendments related to progress in the field of Pharmacovigilance. The book discusses about Council for International Organizations of Medical Sciences (CIOMS), a WHO initiative which focuses on various activities such as expedited reporting, electronic reporting, periodic safety updates, Core clinical Safety information (CCSI), Benefit risk evaluation and Good case management and reporting practices. For the pharmaceutical industry, pharmacovigilance is the post-marketing surveillance of the safety of authorized commercialised medicinal products during their life on the market. Safety and risk management systems need to be strategically integrated alongside business processes. Approach which not only delivers but also controls the overall risk management should be existent with all companies including specifically small and midsize startup companies. Further the distinction between an Adverse event and Adverse reaction has been clearly described, following which significance pertaining to causality assessment has also been emphasized. The intrinsic properties of the drug and the rarity with which a drug gives rise to an adverse reaction has given rise to vast thought provoking discussions by regulators, pharmaceutical companies, pharmacovigilators to arrive at concrete steps that may lead to recognizing safety signals which can aid in minimizing risks. Accordingly signal detection which form yet another key important aspect of pharmacovigilance has been comprehensively discussed.