[Pharmacovigilance in a paediatric intensive care unit]

To analyze suspected drug-related adverse events as reported by pharmacists in a pediatric intensive care unit.

Suspected drug-related adverse events were recorded as reported by pharmacists in an intensive care unit during hospital rounds (these were neither systematic nor continued) or patient visits to our clinic (April 2004-May 2005). Later on, the pharmacovigilance subcommittee prospectively analyzed such suspected events in order to confirm them and classify them according to their rules.

Nineteen suspected adverse events were reported for 17 patients; 15 were confirmed (78%). In six cases the pharmacist suggested the way the adverse event was eventually treated. Three cases required admission to an ICU. Drug classes most commonly involved included antimicrobials, anti-epileptic drugs, and immunosuppressants. Severity was: fatal 20%, serious 34%, moderate 13%, mild 33%. Causality was definitely established for 13%, probable for 54%, and possible for 33% of patients; 20% of events were considered avoidable.

Adverse events reported by pharmacists were few, as they could not attend hospital rounds on a regular basis. Imputability was difficult due to critical patient conditions. Most suspected events were later confirmed. Treatment involved therapy adjustments according to individual patient characteristics.