Survey of unlicensed and off label drug use in paediatric wards in European countries. European Network for Drug Investigation in Children

BMJ. 2000 Jan 8;320(7227):79-82. doi: 10.1136/bmj.320.7227.79.


Objective: To determine the extent of use of unlicensed and off label drugs in children in hospital in five European countries.

Design: Prospective study of drugs administered to children in general paediatric medical wards over four weeks.

Setting: Children's wards in five hospitals (one each in the United Kingdom, Sweden, Germany, Italy, and the Netherlands).

Subjects: Children aged 4 days to 16 years admitted to general paediatric medical wards.

Main outcome measure: Proportion of drugs that were used in an unlicensed or off label manner.

Results: 2262 drug prescriptions were administered to 624 children in the five hospitals. Almost half of all drug prescriptions (1036; 46%) were either unlicensed or off label. Of these 1036, 872 were off label and 164 were unlicensed. Over half of the patients (421; 67%) received an unlicensed or off label drug prescription.

Conclusions: Use of off label or unlicensed drugs to treat children is widespread. This problem is likely to affect children throughout Europe and requires European action.

Publication types

  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Child
  • Child Health Services / organization & administration*
  • Child, Preschool
  • Europe
  • Hospitalization / statistics & numerical data
  • Hospitals, General
  • Humans
  • Infant
  • Infant, Newborn
  • Nonprescription Drugs / therapeutic use*
  • Prospective Studies


  • Nonprescription Drugs