MODULE 10: PHARMACOVIGILANCE

MODULE 10: PHARMACOVIGILANCE WHO/Petterik Wiggersn1681. INTRODUCTIONThis section introduces the concepts of PHARMACOVIGILANCE and adverse drug reactions, discusses the burden of adverse drug reactions for children and explains the importance of PHARMACOVIGILANCE in the context of antiretroviral therapy (ART). Defining pharmacovigilanceWHO defines PHARMACOVIGILANCE as the science and activities related to the detection, assessment, understanding and prevention of adverse effects or any other possible drug-related problem (1). It focuses on investigating and monitoring adverse drug reactions after medicinal products are licensed (2). Adverse drug reactions are a response that is noxious and unintended and that occurs at doses normally used in humans for the prophylaxis, diagnosis or therapy of disease or for modifying physiological function (2).

dedicated information on the safety of medicines for neonates, children and adolescents at the time of marketing authorization is therefore very limited, which poses even more reliance on proper pharmacovigilance in the post-marketing stage (9). Fig. 10.1. Timeline of pharmacovigilance for a drug from development (pre-market) to post-marketing use

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  Safety, Pharmacovigilance, Medicine, Children, Safety of medicines

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