title: Improving the reporting of adverse drug reactions in the hospital setting.
abstract: The US Food and Drug Administration (FDA) is perceived by the public as having a substantial responsibility to ensure drug safety; however, the FDA has limited resources for active surveillance and relies on voluntary reporting of adverse events and potential adverse drug reactions. Studies have shown that underreporting of adverse events and adverse drug reactions is widespread. Furthermore, a review of several studies demonstrates that most adverse drug reactions are reported by pharmacists and nurses, with physicians reporting the fewest. The hospital setting, with its clearly defined patient population observed around the clock, is an ideal setting in which to identify potential adverse drug reaction signals and to report them to either the drug manufacturer or the FDA. In this article we describe the present system for addressing adverse events, obstacles to reporting them, and the important role any hospital physician could play in reporting adverse events and potential adverse drug reactions.
authors.affiliation: Department of Medicine, UCSF Medical Center, San Francisco, CA 94143, USA. richard.pushkin@ucsf.edu
authors.forename: Richard
authors.initials: R
authors.lastname: Pushkin
authors.forename: Lynda
authors.initials: L
authors.lastname: Frassetto
authors.forename: Candy
authors.initials: C
authors.lastname: Tsourounis
authors.forename: Eleanor S
authors.initials: ES
authors.lastname: Segal
authors.forename: Stephanie
authors.initials: S
authors.lastname: Kim
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems / Q000592:standards* / Q000639:trends; D000465:Algorithms; D004342:Drug Hypersensitivity / Q000453:epidemiology / Q000517:prevention & control; D064420:Drug-Related Side Effects and Adverse Reactions; D005260:Female; D006760:Hospitalization / Q000706:statistics & numerical data; D006801:Humans; D007297:Inpatients / Q000706:statistics & numerical data; D008297:Male; D008508:Medication Errors / Q000517:prevention & control; D010601:Pharmacology, Clinical; D010607:Pharmacy Service, Hospital / Q000592:standards / Q000639:trends; D014481:United States; D014486:United States Food and Drug Administration / Q000458:organization & administration*