Pharmacovigilance

Common card · No. 431043

Pharmacovigilance (PV, or PhV), also known as drug safety, is the discipline within pharmaceutical science that addresses the identification, evaluation, and mitigation of adverse effects and other drug-related problems associated with pharmaceutical products. The term ‘pharmacovigilance’ is derived from the Greek pharmakon (meaning ‘drug’) and the Latin vigilare (meaning ‘to keep watch’), reflecting the discipline’s focus on monitoring drug safety.” Adverse drug reactions (ADRs), which are harmful and unintended responses to approved medicinal products, are a central focus of pharmacovigilance. That definition includes lack of efficacy: that means that the doses normally used for prevention, diagnosis, or treatment of a disease—or for the modification of physiological disorder function. In 2010, the European Union expanded the definition to include lack of efficacy and medication errors, recognizing that adverse outcomes extend beyond harmful responses to therapeutic failures and misuse...

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