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Adverse drug reactions in hospitalized Colombian children

Roxana de Las Salas1, Daniela Díaz-Agudelo1, Francisco Javier Burgos-Flórez2

  • 1Grupo de Investigación en Enfermería, Departamento de Enfermería, Universidad del Norte, Barranquilla, Colombia.

Colombia Medica (Cali, Colombia)
|November 9, 2016
PubMed

Insights

Adverse drug reactions (ADRs) are common in hospitalized children under six, affecting 19% of patients. The study highlights increased risk in younger children and those treated with systemic antibiotics, emphasizing the need for better pediatric drug safety data.

Area of Science:

  • Pediatric Pharmacology
  • Clinical Pharmacy
  • Pharmacovigilance

Background:

  • Adverse drug reactions (ADRs) pose a significant risk in pediatric populations due to limited drug safety data.
  • Understanding ADRs in hospitalized children is crucial for improving patient safety and clinical outcomes.

Purpose of the Study:

  • To investigate the incidence and characteristics of Adverse Drug Reactions (ADRs) in children under six years old admitted to general pediatric wards.
  • To identify risk factors associated with ADRs in this vulnerable patient group.

Main Methods:

  • A prospective cohort study employing intensive pharmacovigilance over six months.
  • Utilized Naranjo's Algorithm for causality assessment, Hartwig and Siegel scale for severity, and Schumock and Thornton criteria for preventability.
  • Monitored 772 inpatients under six years old across two hospitals in Barranquilla, Colombia.

Main Results:

  • A total of 156 ADRs were documented in 147 children, with a cumulative incidence of 19.0%.
  • Incidence density was 37.6 ADRs per 1,000 patient-days, with higher frequency observed in children under two years.
  • Male patients and those receiving systemic antibiotics showed a significantly higher risk of ADRs.

Conclusions:

  • Adverse drug reactions are a frequent occurrence in hospitalized children, contributing to increased morbidity.
  • The findings underscore the importance of targeted pharmacovigilance in pediatric settings, especially for those on multiple medications, including antibiotics.
Abstract

Keywords:
ColombiaDrug-related side effectsPediatricsRiskadverse reactionschilddrug monitoringpharmacovigilance

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