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Reported adverse drug reactions and their determinants in Dutch children outside the hospital

Eric Schirm1, Hilde Tobi, Eugène P van Puijenbroek

  • 1Groningen University Institute for Drug Exploration, University of Groningen, Department of Social Pharmacy, Pharmacoepidemiology and Pharmacotherapy, Groningen, The Netherlands.

Pharmacoepidemiology and Drug Safety
|April 10, 2004
PubMed

Insights

Adverse drug reactions (ADRs) in children were disproportionately reported for systemic, new, anti-infective, and nervous system drugs. Drug use patterns alone do not explain these ADRs in the pediatric population.

Area of Science:

  • Pediatric pharmacology
  • Drug safety surveillance
  • Pharmacovigilance

Background:

  • Studies on pediatric adverse drug reactions (ADRs) outside hospitals lack control groups, hindering interpretation.
  • Understanding drug use patterns is crucial for analyzing ADRs in children.

Purpose of the Study:

  • To describe ADRs in children outside the hospital.
  • To control for drug use in the general pediatric population using a case-control design.

Main Methods:

  • A case-control study compared drugs reported for suspected ADRs to the Netherlands Pharmacovigilance Centre LAREB with drugs used in the general pediatric population.
  • Data from the InterAction pharmacy database for children aged 0-16 years in 2001 were analyzed.

Main Results:

  • Systemic, new, anti-infective, and nervous system drugs were disproportionately reported for ADRs.
  • Unlicensed, frequently used, and dermatological drugs were less associated with reported ADRs.
  • Off-label prescription proportions did not differ between ADR-suspected drugs and general pediatric drug use.

Conclusions:

  • The observed patterns of drugs associated with pediatric ADRs cannot be solely attributed to general drug utilization patterns.
  • Further research is needed to understand the specific factors contributing to ADRs in children.
Abstract

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