title: Adverse event reporting in adult intensive care units and the impact of a multifaceted intervention on drug-related adverse events.
abstract: BACKGROUND
  Adverse events (AEs) frequently occur in intensive care units (ICUs) and affect negatively patient outcomes. Targeted improvement strategies for patient safety are difficult to evaluate because of the intrinsic limitations of reporting crude AE rates. Single interventions influence positively the quality of care, but a multifaceted approach has been tested only in selected cases. The present study was designed to evaluate the rate, types, and contributing factors of emerging AEs and test the hypothesis that a multifaceted intervention on medication might reduce drug-related AEs.
  
  
  METHODS
  This is a prospective, multicenter, before-and-after study of adult patients admitted to four ICUs during a 24-month period. Voluntary, anonymous, self-reporting of AEs was performed using a detailed, locally designed questionnaire. The temporal impact of a multifaceted implementation strategy to reduce drug-related AEs was evaluated using the risk-index scores methodology.
  
  
  RESULTS
  A total of 2,047 AEs were reported (32 events per 100 ICU patient admissions and 117.4 events per 1,000 ICU patient days) from 6,404 patients, totaling 17,434 patient days. Nurses submitted the majority of questionnaires (n = 1,781, 87%). AEs were eye-witnessed in 49% (n = 1,003) of cases and occurred preferentially during an elective procedure (n = 1,597, 78%) and on morning shifts (n = 1,003, 49%), with a peak rate occurring around 10 a.m. Drug-related AEs were the most prevalent (n = 984, 48%), mainly as a consequence of incorrect prescriptions. Poor communication among caregivers (n = 776) and noncompliance with internal guidelines (n = 525) were the most prevalent contributing factors for AE occurrence. The majority of AEs (n = 1155, 56.4%) was associated with minimal, temporary harm. Risk-index scores for drug-related AEs decreased from 10.01 ± 2.7 to 8.72 ± 3.52 (absolute risk difference 1.29; 95% confidence interval, 0.88-1.7; p < 0.01) following the introduction of the intervention.
  
  
  CONCLUSIONS
  AEs occurred in the ICU with a typical diurnal frequency distribution. Medication-related AEs were the most prevalent. By applying the risk-index scores methodology, we were able to demonstrate that our multifaceted implementation strategy focused on medication-related adverse events allowed to decrease drug related incidents.
authors.affiliation: Department of Intensive Care Medicine of the Ente Ospedaliero Cantonale (EOC), Intensive Care Units of the Regional Hospitals Mendrisio, Locarno, Bellinzona and Lugano, Switzerland. guido.domenighetti@eoc.ch.
authors.forename: Alberto
authors.initials: A
authors.lastname: Pagnamenta
authors.forename: Giovanni
authors.initials: G
authors.lastname: Rabito
authors.forename: Alessandra
authors.initials: A
authors.lastname: Arosio
authors.forename: Andreas
authors.initials: A
authors.lastname: Perren
authors.forename: Roberto
authors.initials: R
authors.lastname: Malacrida
authors.forename: Fabrizio
authors.initials: F
authors.lastname: Barazzoni
authors.forename: Guido
authors.initials: G
authors.lastname: Domenighetti