title: The incident reporting system does not detect adverse drug events: a problem for quality improvement.
abstract: OBJECTIVE
  The objectives of this study were 1) to determine the frequency with which adverse drug events result in an incident report (IR) in hospitalized patients; and 2) to determine if there were differences 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.
  
  
  METHODS
  All patients 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 events (ADEs) and IRs. Consensus voting was used by senior hospital administrators, nursing leaders, and staff nurses to determine whether an adverse drug event should have been reported and would have been reported.
  
  
  RESULTS
  Of 54 adverse drug events identified by the study, only 3 patients (6%) had a corresponding incident report submitted to the hospital'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-threatening, yet only 2 of the 26 led to an incident report. The three voting groups agreed that most ADEs justified an IR, but judged that in actual practice, an IR would infrequently have been filed.
  
  
  CONCLUSIONS
  Voluntary reporting identified only a small fraction of ADEs. Using IRs for quality assurance/quality improvement will lead to significant bias when assessing quality of care.
authors.affiliation: Harvard Medical School, Massachusetts General Hospital, Boston, USA.
authors.forename: D J
authors.initials: DJ
authors.lastname: Cullen
authors.forename: D W
authors.initials: DW
authors.lastname: Bates
authors.forename: S D
authors.initials: SD
authors.lastname: Small
authors.forename: J B
authors.initials: JB
authors.lastname: Cooper
authors.forename: A R
authors.initials: AR
authors.lastname: Nemeskal
authors.forename: L L
authors.initials: LL
authors.lastname: Leape
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems / Q000592:standards*; D001291:Attitude of Health Personnel; D001900:Boston; D016009:Chi-Square Distribution; D016903:Drug Monitoring / Q000592:standards* / Q000706:statistics & numerical data; D064420:Drug-Related Side Effects and Adverse Reactions; D004868:Equipment Failure; D005568:Forms and Records Control / Q000592:standards*; D006801:Humans; D008508:Medication Errors; D016134:Organizational Policy; D012308:Risk Management / Q000592:standards*; D017749:Total Quality Management