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 etymological roots for the word "pharmacovigilance" are: pharmakon (Greek for drug) and vigilare (Latin for to keep watch). A central concern in pharmacovigilance is adverse drug reactions (ADR), defined as harmful and unintended responses to a medicinal product. That definition includes lack of efficacy: that means that the doses normally used for prevention, diagnosis, or treatment of a disease—or, especially in the case of device, for the modification of physiological disorder function. In 2010, the European Union expanded PV to include medication errors such as overdose, misuse, and abuse of a drug as well as drug exposure during pregnancy and breastfeeding. These are monitored even in the absence of an adverse event, because they may result in an adverse drug reaction. The U.S. Food and Drug Administration (FDA) requires that medication errors, overdose, misuse, abuse, and exposure during pregnancy or breastfeeding be included in its pharmacovigilance framework.
