TabsDetailsBasic DetailsDate: Thursday, January 19, 2012Type: PublicationDescription: This article describes design considerations in developing an active medical product safety monitoring system that utilizes routinely collected electronic healthcare data. Suitable approaches to minimizing false positives and false negatives depend on the characteristics of 1) the monitored product, 2) the health outcome of interest (HOI), and 3) the potential link between them. Read More Materials: Pharmacoepidemiology and Drug Safety, Volume 21, Issue Supplement S1, January 2012, Pages 32-40, DOI: 10.1002/pds.2316Additional InformationRelated Assessment(s): PDS Supplement: The U.S. Food and Drug Administration's Mini-Sentinel ProgramContributorsAuthor(s): Joshua J. Gagne PharmD, ScD; Bruce Fireman, MA; Patrick B. Ryan PhD; Malcolm Maclure SM, SD; Tobias Gerhard PhD; Sengwee Toh ScD; Jeremy A. Rassen ScD; Jennifer C. Nelson PhD; Sebastian Schneeweiss MD, ScDCorresponding Author: J. J. Gagne, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, 1620 Tremont Street, Suite 3030, Boston, MA 02120, USA. Email: jgagne1@partners.org
