Adverse drug reactions in hospitalized children in Fortaleza, Brazil.
OBJECTIVE
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.


METHODS
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.


CONCLUSIONS
ADRs are not uncommon among hospitalized children, particularly those with prior histories of hospitalization and concomitant use of several medicines.
dos Santos
Djanilson Barbosa
DB
Master in Clinical Pharmacy, Federal University of Ceara, Fortaleza, Ceara, Brazil. dejab@bol.com.br
Coelho
Helena Lutéscia Luna
HL
D000293:Adolescent; D016907:Adverse Drug Reaction Reporting Systems; D001938:Brazil; D002648:Child; D002675:Child, Preschool; D015331:Cohort Studies; D064420:Drug-Related Side Effects and Adverse Reactions; D005260:Female; D006776:Hospitals, Pediatric / Q000592:standards; D006801:Humans; D015994:Incidence; D007223:Infant; D008297:Male; D004364:Pharmaceutical Preparations / Q000008:administration & dosage; D011446:Prospective Studies; D012307:Risk Factors
D004364:Pharmaceutical Preparations