Transcription of MODULE 10: PHARMACOVIGILANCE
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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).
Another systematic review focused on studies quantifying the association between drug exposure and adverse drug reactions among children and adolescents younger than 18 years (19). Surprisingly, only 268 relevant articles were retrieved, with an increase in the number published over time, as Fig. 10.2 demonstrates.
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