Improving the reporting of adverse drug reactions in the hospital setting

Postgrad Med. 2010 Nov;122(6):154-64. doi: 10.3810/pgm.2010.11.2233.

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.

Publication types

  • Research Support, Non-U.S. Gov't
  • Review

MeSH terms

  • Adverse Drug Reaction Reporting Systems / standards*
  • Adverse Drug Reaction Reporting Systems / trends
  • Algorithms
  • Drug Hypersensitivity / epidemiology
  • Drug Hypersensitivity / prevention & control
  • Drug-Related Side Effects and Adverse Reactions*
  • Female
  • Hospitalization / statistics & numerical data
  • Humans
  • Inpatients / statistics & numerical data
  • Male
  • Medication Errors / prevention & control
  • Pharmacology, Clinical
  • Pharmacy Service, Hospital / standards
  • Pharmacy Service, Hospital / trends
  • United States
  • United States Food and Drug Administration / organization & administration*