When I use a word . . . Medical definitions: Pharmacovigilance

Based on its etymology, previous definitions, and an examination of the practical processes involved, I suggest the following extensional definition of pharmacovigilance: pharmacovigilance, n. A scientific surveillance activity that can be carried out both before and after marketing of a medicinal or other therapeutic product, involving identification and quantification of signals that suggest the occurrence of previously unrecognised harms and their dose-responsiveness and time course, identification and refutation of false-positive signals that thus arise, elucidation of a product’s pharmacological and toxicological properties and the relevant mechanism(s) that mediate benefits and harms, identification of factors that contribute to the risks of harms, including the method of administration and factors that render subgroups of patients at particular risk (i.e. susceptible individuals), description of the comparative adverse effects profile of products within the same therapeutic class, continued surveillance of a product throughout the duration of its use, detection of medication errors and their sources, detection of clinically important interactions with other therapeutic or diagnostic products, and communication of appropriate information to healthcare professionals and the public. [ancient Greek ϕαρμακο-, combining form, from ϕάρμακον drug, medicine, poison, and Latin vigilare to be watchful or alert, via French vigilance.]