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A prospective study of adverse drug reactions in hospitalized children
I Martínez-Mir1, M García-López, V Palop
1Departament de Farmacologia, Universitat de València, València, Spain.
Insights
Adverse drug reactions (ADRs) occurred in 16.6% of hospitalized children aged 1-24 months. Female sex and increased drug administration were risk factors for ADRs in this pediatric population.
Area of Science:
- Pediatric Pharmacology
- Clinical Pharmacy
- Drug Safety
Background:
- Adverse drug reactions (ADRs) are a significant concern in pediatric populations, with limited data on incidence and risk factors.
- Previous studies suggest higher ADR rates in infants and male patients, necessitating further investigation.
Purpose of the Study:
- To prospectively assess the incidence, pattern, and risk profile of ADRs in hospitalized pediatric patients aged 1 to 24 months.
- To identify specific demographic and clinical factors associated with ADRs in this age group.
Main Methods:
- A prospective observational study involving intensive adverse event monitoring.
- Analysis of 512 successive admissions to pediatric wards over two distinct periods (summer and winter).
- Daily screening of hospital records for adverse clinical events.
Main Results:
- A cumulative incidence of 16.6% for ADRs was observed among hospitalized pediatric patients.
- Risk of ADRs was significantly higher in female patients compared to males (RR=1.66).
- The gastro-intestinal system was most frequently affected, with anti-infective drugs and vaccines being the most implicated therapeutic group.
Conclusions:
- Female sex and the number of drugs administered were identified as key risk factors for ADRs in hospitalized pediatric patients.
- No significant age predisposition for ADRs was observed between infants under and over 12 months.
- The most frequently prescribed medications were also the most commonly associated with ADRs in this cohort.
Aims:
There are few publications of adverse drug reactions (ADRs) among paediatric patients, though ADR incidence is usually stated to be higher during the first year of life and in male patients. We have carried out a prospective study to assess the extent, pattern and profile risk for ADRs in hospitalized patients between 1 and 24 months of age.
Methods:
An intensive events monitoring scheme was used. A total of 512 successive admissions to two medical paediatric wards (47 beds) were analysed. The hospital records were screened daily during two periods (summer, 105 days and winter, 99 days), and adverse clinical events observed were recorded.
Results:
A total of 282 events were detected; of these, 112 were considered to be manifestations of ADRs. The cumulative incidence was 16.6%, no differences being observed between periods. Although there were no differences between patients under and over 12 months of age, risk was found to be significantly higher among girls compared with boys (RR=1.66, 95% CI 1.03-2.52). The gastro-intestinal system was most frequently affected. The therapeutic group most commonly implicated was anti-infective drugs and vaccines (41.5%). The ADRs were mild or moderate in over 90% of cases. A consistent relationship was noted between the number of drugs administered and the incidence of ADRs.
Conclusions:
Hospitalized patients exhibited an ADR risk profile that included female sex and the number of drugs administered. No particular age predisposition was observed. The most commonly prescribed drugs are those most often implicated in ADRs in paediatric patients.