title: New approaches to drug safety: a pharmacovigilance tool kit.
abstract: The importance of pharmacovigilance - the ongoing assessment of the safety of a marketed medicine - has been increasingly appreciated in recent years, owing in part to high-profile safety issues with widely used drugs. In response, strategies to improve the collection, integration and analysis of data related to post-marketing drug safety are being initiated or enhanced. In this article, we summarize the key tools that are available for pharmacovigilance, discuss which might be the most appropriate to use in different situations and consider the future directions of the field.
authors.affiliation: Medicines and Healthcare products Regulatory Agency, Market Towers, 1 Nine Elms Lane, London SW8 5NQ, UK.
authors.forename: Lesley
authors.initials: L
authors.lastname: Wise
authors.forename: John
authors.initials: J
authors.lastname: Parkinson
authors.forename: June
authors.initials: J
authors.lastname: Raine
authors.forename: Alasdair
authors.initials: A
authors.lastname: Breckenridge
mesh_terms: D000818:Animals; D002986:Clinical Trials as Topic / Q000009:adverse effects / Q000379:methods; D017277:Drug Approval / Q000379:methods; D004345:Drug Industry / Q000379:methods / Q000639:trends*; D064420:Drug-Related Side Effects and Adverse Reactions; D006801:Humans; D011358:Product Surveillance, Postmarketing / Q000379:methods / Q000639:trends