IDENTIFYING ADVERSE DRUG EVENTS - DEVELOPMENT OF A COMPUTER-BASED MONITOR AND COMPARISON WITH CHART REVIEW AND STIMULATED VOLUNTARY REPORT

Background: Adverse drug events (ADEs)aye both common and costly. Most hospitals identify ADEs using spontaneous reporting, but this approac h lacks sensitivity; chart review identifies more events but is expens ive. Computer-based approaches to ADE identification appear promising, but they have not been directly compared with chart review and they a re not widely used. Objectives: To develop a computer-based ADE monito r, and to compare the rate and type of ADEs found with the monitor wit h those discovered by chart review and by stimulated voluntary report. Design: Prospective cohort study in one tertiary-care hospital. Parti cipants: All patients admitted to nine medical and surgical units in a tertiary-care hospital over an eight-month period. Main Outcome Measu re: Adverse drug events identified by the computer-based monitor, by c hart review, and by stimulated voluntary report. Methods: A computer-b ased monitoring program identified alerts, which were situations sugge sting that an ADE might be present (e.g., an order for an antidote suc h as naloxone). A trained reviewer then examined patients' hospital re cords to determine whether an ADE had occurred. The results of the com puter-based monitoring strategy were compared with two other ADE detec tion strategies: intensive chart review and stimulated voluntary repor t by nurses and pharmacists. The monitor and the chart review strategi es were independent, and the reviewers were blinded. Results: The comp uter monitoring strategy identified 2,620 alerts, of which 275 were de termined to be ADEs. The chart review found 398 ADEs, whereas voluntar y report detected 23. Of the 617 ADEs detected by at least one method, 76 ADEs were detected by both computer monitor and chart review. The computer monitor identified 45 percent; chart review, 65 percent; and voluntary report, 4 percent. The ADEs identified by computer monitor w ere more likely to be classified as ''severe'' than were those identif ied by chart review (51 versus 42 percent, p =.04). The positive predi ctive value of computer-generated alerts was 16 percent during the fir st eight weeks of the study; rule modifications increased this to 23 p ercent in the final eight weeks. The computer strategy required 11 per son-hours per week to execute, whereas chart review required 55 person -hours per week and voluntary report strategy required 5.