BMJ 2000;320:79-82 ( 8 January )

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

Sharon Conroy, lecturer in paediatric clinical pharmacology, a Imti Choonara, professor, a Piero Impicciatore, research fellow, a Angelika Mohn, research fellow, a Henrik Arnell, research fellow, b Anders Rane, professor of clinical pharmacology, b Carmen Knoeppel, medical student, c Hannsjoerg Seyberth, professor of paediatrics, c Chiara Pandolfini, research fellow, d Maria Pia Raffaelli, hospital pharmacist, d Francesca Rocchi, research fellow, d Maurizio Bonati, head of unit, d Geert `t Jong, research fellow, e Matthijs de Hoog, consultant in paediatric critical care, e John van den Anker, professor in paediatrics and neonatology, e on behalf of the European Network for Drug Investigation in Children.

a Academic Division of Child Health (University of Nottingham), Derbyshire Children's Hospital, Derby DE22 3NE, b University Hospital, Uppsala, Sweden, c University Children's Hospital, Marburg, Germany, d Mario Negri Institute, Milan, Italy, e Department of Paediatrics (Erasmus University Rotterdam), Sophia Children's Hospital, Rotterdam, Netherlands

Correspondence to: I Choonara Imti.choonara{at}nottingham.ac.uk

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




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