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Survey of unlicensed and off label drug use in paediatric wards in European countries

BMJ 2000; 320 doi: (Published 08 January 2000) Cite this as: BMJ 2000;320:79
  1. Sharon Conroy, lecturer in paediatric clinical pharmacologya,
  2. Imti Choonara, professor (Imti.choonara{at},
  3. Piero Impicciatore, research fellowa,
  4. Angelika Mohn, research fellowa,
  5. Henrik Arnell, research fellowb,
  6. Anders Rane, professor of clinical pharmacologyb,
  7. Carmen Knoeppel, medical studentc,
  8. Hannsjoerg Seyberth, professor of paediatricsc,
  9. Chiara Pandolfini, research fellowd,
  10. Maria Pia Raffaelli, hospital pharmacistd,
  11. Francesca Rocchi, research fellowd,
  12. Maurizio Bonati, head of unitd,
  13. Geert't Jong, research fellowe,
  14. Matthijs de Hoog, consultant in paediatric critical caree,
  15. John van den Anker, professor in paediatrics and neonatology on behalf of the European Network for Drug Investigation in Childrene
  1. a Academic Division of Child Health (University of Nottingham), Derbyshire Children's Hospital, Derby DE22 3NE
  2. b University Hospital, Uppsala, Sweden
  3. c University Children's Hospital, Marburg, Germany
  4. d Mario Negri Institute, Milan, Italy
  5. e Department of Paediatrics (Erasmus University Rotterdam), Sophia Children's Hospital, Rotterdam, Netherlands
  1. Correspondence to: I Choonara
  • Accepted 1 November 1999


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.

Key messages

  • Many drugs are not tested in children, which means that they are not specifically licensed for use in children

  • Licensed drugs are often prescribed outside the terms of the product license (off label) in relation to age, indication, dose of frequency, route of administration, or formulation

  • Over two thirds (67%) of 624 children admitted to wards in five European hospitals received drugs prescribed in an unlicensed or off label manner

  • 39% of the 2262 drug prescriptions given to children were off label

  • The problem of off label and unlicensed drug prescribing in children is a European problem that requires European action


  • Funding None.

  • Competing interests IC, AR, HS, and JA attended a round table meeting of experts on the use of new medicines in children organised by EMEA in 1997. IC has a grant from the Medicines Control Agency in the United Kingdom in relation to drug reaction surveillance in children.

  • Accepted 1 November 1999
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