An ADR surveillance program: increasing quality, number of incidence reports.

Abstract

An Adverse Drug Reaction Surveillance Program (ADRSP) was implemented by the pharmacy department of the University of Maryland Medical System to address the institution's underreporting of adverse drug reactions. The program aims were to increase the number and quality of significant adverse drug reaction (ADR) reports by facilitating and standardizing the reporting process, to more actively involve the pharmacy staff, and to create a comprehensive database, thus enabling the intervention of future untoward events. During the program's first 2 years, the number of ADR reports more than doubled, primarily due to increased pharmacists' participation. The ADRSP has facilitated the reporting process, enhanced the submission of ADR reports to the FDA, and helped prevent ADRs.