THE INCIDENT REPORTING SYSTEM DOES NOT DETECT ADVERSE DRUG EVENTS - APROBLEM FOR QUALITY IMPROVEMENT

Objectives: The objectives of this study were 1) to determine the freq uency with which adverse drug events result in an incident report (IR) in hospitalized patients; and 2) to determine if there were differenc es between quality assurance administrators, nurse leaders in quality assurance, and staff nurses as to whether an incident report should or would be filed for each adverse drug event. Study design: All patient admitted to five patient care units (one medical intensive care unit, two surgical intensive care units, and two medical general care units ) in one academic tertiary care hospital were studied between February and July 1993. The main outcome measures used were adverse drug event s (ADEs) and IRs. Consensus voting was used by senior hospital adminis trators, nursing leaders, and staff nurses to determine whether an adv erse drug event should have been reported and would have been reported . Results: Of 54 adverse drug events identified by the study, only 3 p atients (6%) had a corresponding incident report submitted to the hosp ital's quality assurance program or called into the pharmacy hotline. One additional ADE was identified by an IR, but not by the ADE study. Of the 55 ADEs, 15 were preventable, and 26 were serious or life-threa tening, yet only 2 of the 26 led to an incident report. The three voti ng groups agreed that most ADEs justified an IR, but judged that in ac tual practice, an IR would infrequently have been filed. Conclusions: Voluntary reporting identified only a small fraction of ADEs. Using IR s for quality assurance/quality improvement will lead to significant b ias when assessing quality of care.