PURPOSE: To investigate the occurrence of adverse drug reactions (ADRs) and associated risk factors in a pediatric hospital in northeast Brazil, from August to December 2001. SUBJECTS/SETTING: Two hundred seventy two patients hospitalized for more than 24 hours. METHODS: Prospective cohort study. Daily visits were performed for inclusion or attendance of patients and collection of information on drug prescriptions and medical events. The visits were focused on the detection of adverse events. WHO categories were used to assess the imputability and severity of suspected ADRs. RESULTS: Two hundred sixty five patients (97%) were exposed to medicines during hospitalization; the most frequent diagnosis was pneumonia (30%), the therapeutic class most prescribed was anti-infectives for systemic use (26%). Of a total of 420 adverse events, 47 ADRs were detected in 33 of 265 children treated with drugs. The cumulative incidence of ADRs was 12.5% (33/265); incidence density was 8 events per 1000 patient days (33/4042 patient-days). The skin was the most affected organ (49%); the drugs more implicated were systemic antibiotic (53.2%). The ADRs were mild or moderate in 97.9% of cases; causality was probable in 57.5% and the majority of events were independent of the dose given (55.3%). In multivariate analysis, the risk of ADR increased with the number of drugs, male gender, and > or =3 previous hospitalization courses. CONCLUSION: ADRs are not uncommon among hospitalized children, particularly those with prior histories of hospitalization and concomitant use of several medicines.
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