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Off-label prescribing to children in primary care: retrospective observational study

Suzie Ekins-Daukes1, Peter J Helms, Colin R Simpson

  • 1Department of Medicine and Therapeutics, The University of Aberdeen, Polwarth Building, Foresterhill, Aberdeen AB25 2ZD, Scotland, UK.

European Journal of Clinical Pharmacology
|May 18, 2004
PubMed

Insights

Off-label prescribing is common in Scottish primary care, affecting over a quarter of children. Dosing inaccuracies, particularly lower doses, were most frequent, alongside issues with age and formulation appropriateness.

Area of Science:

  • Pediatric Pharmacology
  • General Practice Research
  • Drug Utilization Studies

Background:

  • Off-label prescribing in children is a significant concern due to potential safety and efficacy issues.
  • Limited data exists on the extent and patterns of pediatric off-label prescribing in UK primary care.

Purpose of the Study:

  • To determine the prevalence and characteristics of off-label medication use in children within Scottish primary care.
  • To identify the main reasons for off-label prescribing in this pediatric population.

Main Methods:

  • A large-scale retrospective analysis of prescribing data from 161 general practices in Scotland.
  • Involved assessment of prescriptions for 167,865 children aged 0-16 years between November 1999 and October 2000.
  • Utilized data from the General Practice Administration System for Scotland (GPASS).

Main Results:

  • Over a quarter of children (26.1%) received at least one off-label prescription.
  • The most common off-label use involved incorrect dosage (lower or higher than recommended), particularly for antibiotics and antiasthmatics.
  • Prescribing outside recommended age ranges and formulations was less frequent.

Conclusions:

  • This study represents the most extensive analysis of pediatric off-label prescribing in UK primary care to date.
  • Factors contributing to off-label prescribing include outdated licensing information, lack of awareness, insufficient clinical trial data, and unavailability of suitable pediatric formulations.
  • Addressing these issues is crucial for improving the safe and effective use of medications in children.
Abstract

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