Development of a computerized adverse drug event monitor.

Adverse events during drug therapy are receiving renewed attention. Some adverse drug events (ADEs) are identified only after the widespread clinical use of a drug. The Food and Drug Administration advocates post-marketing surveillance systems to provide early warnings of previously undetected ADEs. The identification of ADEs by U.S. hospitals is now required by the Joint Commission on Accreditation of Healthcare Organizations. We developed a series of computer programs and data files on the HELP System to help identify ADEs. The HELP System monitors laboratory test results, drug orders, and data entered through a computerized ADE reporting program. A nurse or pharmacist verifies computer alerts of possible ADEs. The computerized system identified 401 ADEs during the first year of use compared to 9 by voluntary reporting methods during the previous year (p less than 0.001). This paper describes the development and early use of the computerized ADE surveillance system.