Pharmacovigilance

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Pharmacovigilance (PV, or PhV), also known as drug safety, is the pharmaceutical science relating to the "collection, detection, assessment, monitoring, and prevention" of adverse effects with pharmaceutical products.^[1]: 7

The etymological roots for the word "pharmacovigilance" are: pharmakon (Greek for drug) and vigilare (Latin for to keep watch). As such, pharmacovigilance heavily focuses on adverse drug reactions (ADR), which are defined as any response to a drug which is noxious and unintended. 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^[2] 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.^[3] The US FDA has long considered such criteria to conform to reportable and collectible PV standards.

Patient and healthcare provider reports (via pharmacovigilance agreements or national mandated reporting laws), as well as other sources such as cases reported in medical literature, play a critical role in providing the data necessary for pharmacovigilance to take place. In order to market or to test a pharmaceutical product in most countries, adverse event data received by the license holder (usually a pharmaceutical company) must be submitted to the national drug regulatory authority. (See Adverse event reporting below.)

Ultimately, pharmacovigilance is concerned with identifying the hazards associated with pharmaceutical products and with minimizing the risk of any harm that may come to patients. Companies must conduct a comprehensive drug safety and pharmacovigilance audit to assess their compliance with local, regional, national, or international laws and regulations. This includes ongoing collection of safety data after a product is approved for marketing.^[4]