title: Monitoring product safety in the postmarketing environment.
abstract: The safety profile of a medicinal product may change in the postmarketing environment. Safety issues not identified in clinical development may be seen and need to be evaluated. Methods of evaluating spontaneous adverse experience reports and identifying new safety risks include a review of individual reports, a review of a frequency distribution of a list of the adverse experiences, the development and analysis of a case series, and various ways of examining the database for signals of disproportionality, which may suggest a possible association. Regulatory agencies monitor product safety through a variety of mechanisms including signal detection of the adverse experience safety reports in databases and by requiring and monitoring risk management plans, periodic safety update reports and postauthorization safety studies. The United States Food and Drug Administration is working with public, academic and private entities to develop methods for using large electronic databases to actively monitor product safety. Important identified risks will have to be evaluated through observational studies and registries.
authors.affiliation: United BioSource Corporation, 920 Harvest Drive, Blue Bell, PA 19422, USA.
authors.forename: Robert G
authors.initials: RG
authors.lastname: Sharrar
authors.affiliation: United BioSource Corporation, Blue Bell, PA, USA.
authors.forename: Gretchen S
authors.initials: GS
authors.lastname: Dieck
keywords: pharmacovigilance; product safety; signal detection
references.citation: Pharmacoepidemiol Drug Saf. 2001 Oct-Nov;10(6):483-6
references.pmid: 11828828
references.citation: Eur J Clin Pharmacol. 1998 Jun;54(4):315-21
references.pmid: 9696956
references.citation: Ann Intern Med. 2010 Nov 2;153(9):600-6
references.pmid: 21041580
references.citation: Vaccine. 2000 Nov 22;19(7-8):916-23
references.pmid: 11115716
references.citation: Expert Rev Vaccines. 2002 Dec;1(4):461-6
references.pmid: 12901584
references.citation: Pharmacoepidemiol Drug Saf. 2012 Jan;21 Suppl 1:1-8
references.pmid: 22262586
references.citation: Ther Adv Drug Saf. 2013 Oct;4(5):220-8
references.pmid: 25114783