Pharmacovigilance: what is it and how to report adverse events

Pharmacovigilance is a regulatory activity that continues to evolve and adjust to medicines coming to market and their potential impact on those exposed, which at times includes indirect exposure. It has developed to recognise environmental impact and there is increasing focus on efficacy of medicines. It is important that even when an event, degree of resistance or partial efficacy is already acknowledged, we still remain vigilant as the incidence of the event needs to be monitored to ensure that what was originally noted is consistent with what arises subsequently, and guidance can be amended accordingly. This article provides a background to pharmacovigilance and provides practitioners with a guide to reporting adverse events in the UK.