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

Eur J Clin Pharmacol. 2004 Jul;60(5):349-53. doi: 10.1007/s00228-004-0752-1. Epub 2004 May 14.


Objectives: To investigate the extent and pattern of off-label prescribing to children in primary care throughout Scotland.

Design: Assessment of prescribing to 167,865 children aged 0-16 years during the period November 1999 to October 2000 using data from 161 general practices using the national Scottish primary care computer system General Practice Administration System for Scotland.

Setting: One hundred and sixty one general practices in Scotland.

Results: During the study period, at least one off-label prescription was issued to 17,715 (26.1%) children aged 0-16 years. Off-label prescribing due to lower than the recommended dose was the most common form of off-label prescribing (40-50%), with antibiotics and antihistamines making up the majority. Off-label prescribing due to higher than the recommended dose was also common (35% of all off-label prescribing), with antiasthmatics, topical corticosteroids and laxatives making up the majority. Off-label prescribing with respect to age was less common (6-16%) affecting mainly young children (less than 2 years old) and adolescents. Off-label prescribing with respect to formulation was the least common cause accounting for 5-10% of off-label prescribing.

Conclusions: This is the largest and most detailed study to date of paediatric off-label prescribing in primary care within the UK. Such off-label prescribing likely occurs as the result of several factors including a failure to update licensing information with currently accepted practice and confusion or unawareness of the licensing recommendations, further compounded by a lack of clinical trials data and suitable formulations for medicines commonly prescribed to young children and adolescents.

MeSH terms

  • Adolescent
  • Anti-Bacterial Agents / administration & dosage*
  • Anti-Inflammatory Agents, Non-Steroidal / administration & dosage*
  • Chemistry, Pharmaceutical
  • Child
  • Child, Preschool
  • Drug Labeling
  • Humans
  • Infant
  • Infant, Newborn
  • Licensure
  • Medical Records Systems, Computerized
  • Practice Patterns, Physicians'*
  • Primary Health Care*
  • Retrospective Studies
  • Scotland


  • Anti-Bacterial Agents
  • Anti-Inflammatory Agents, Non-Steroidal