Pharmacovigilance

Abstract

Fatal outcomes related to the use of drugs in the past, for example, most prominently, the thalidomide tragedy, has caused the development of systematic, structured and regulated pharmacovigilance system in the 1960s. Pharmacovigilance includes processes for monitoring and evaluating adverse drug effects with the aim to improve the safety of a drug therapy. Core functions of pharmacovigilance are case management, signal management, and benefit-risk management. They cover the early stages in a drug’s life cycle, but also, as it is impossible to identify all safety concerns during clinical trials, post-marketing observational analyses. In later stages of a drug’s life cycle safety monitoring is based on spontaneous reporting of ADEs. In the EU and the USA, good pharmacovigilance systems are established; however, in some middle- and low-income countries, pharmacovigilance is still at its beginning or not available.

This chapter focusses on pharmacovigilance, describing how it works, what methods are used, describing more or less advanced pharmacovigilance systems in different countries, what an adverse drug effect and an adverse drug event is, and how to prevent and to manage adverse drug effects, especially in the field of neuropsychopharmacology.