Adverse drug events in an intensive care unit of a university hospital

Eur J Clin Pharmacol. 2011 Jun;67(6):625-32. doi: 10.1007/s00228-010-0987-y. Epub 2011 Jan 19.


Purpose: Adverse drug events (ADEs) are harmful and occur with alarming frequency in critically ill patients. Complex pharmacotherapy with multiple medications increases the probability of a drug interaction (DI) and ADEs in patients in intensive care units (ICUs). The objective of the study is to determine the frequency of ADEs among patients in the ICU of a university hospital and the drugs implicated. Also, factors associated with ADEs are investigated.

Methods: This cross-sectional study investigated 299 medical records of patients hospitalized for 5 or more days in an ICU. ADEs were identified through intensive monitoring adopted in hospital pharmacovigilance and also ADE triggers. Adverse drug reactions (ADR) causality was classified using the Naranjo algorithm. Data were analyzed through descriptive analysis, and through univariate and multiple logistic regression.

Results: The most frequent ADEs were ADRs type A, of possible causality and moderate severity. The most frequent ADR was drug-induced acute kidney injury. Patients with ADEs related to DIs corresponded to 7% of the sample. The multiple logistic regression showed that length of hospitalization (OR = 1.06) and administration of cardiovascular drugs (OR = 2.2) were associated with the occurrence of ADEs.

Conclusion: Adverse drug reactions of clinical significance were the most frequent ADEs in the ICU studied, which reduces patient safety. The number of ADEs related to drug interactions was small, suggesting that clinical manifestations of drug interactions that harm patients are not frequent in ICUs.

MeSH terms

  • Critical Illness
  • Cross-Sectional Studies
  • Drug Interactions
  • Drug-Related Side Effects and Adverse Reactions* / epidemiology*
  • Hospitalization
  • Hospitals, University*
  • Humans
  • Intensive Care Units*
  • Length of Stay
  • Medication Errors
  • Polypharmacy
  • Prevalence
  • Safety Management