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Adverse drug reactions in hospitalized children in Fortaleza, Brazil
Djanilson Barbosa dos Santos1, Helena Lutéscia Luna Coelho
1Master in Clinical Pharmacy, Federal University of Ceara, Fortaleza, Ceara, Brazil. dejab@bol.com.br
Insights
Adverse drug reactions (ADRs) occurred in 12.5% of hospitalized children, with risk factors including multiple medications and prior hospitalizations. Most ADRs were mild and skin-related, often linked to systemic antibiotics.
Area of Science:
- Pediatric pharmacology
- Clinical pharmacy
- Drug safety surveillance
Background:
- Adverse drug reactions (ADRs) pose a significant risk in pediatric hospital settings.
- Understanding ADR occurrence and risk factors is crucial for patient safety.
Purpose of the Study:
- To investigate the incidence and risk factors of ADRs in hospitalized children.
- To analyze drug-related events in a pediatric hospital in northeast Brazil.
Main Methods:
- Prospective cohort study involving 272 pediatric patients hospitalized for over 24 hours.
- Daily monitoring for drug prescriptions, medical events, and adverse events.
- Utilized WHO categories for assessing ADR imputability and severity.
Main Results:
- ADRs were detected in 12.5% of 265 children exposed to medications.
- Systemic antibiotics were the most implicated drug class (53.2%), with skin reactions being most common (49%).
- Increased risk of ADRs was associated with multiple drug use, male gender, and previous hospitalizations.
Conclusions:
- ADRs are a notable concern in hospitalized pediatric populations.
- Children with a history of hospitalizations and polypharmacy are at higher risk for ADRs.
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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