News Release

European action needed to ensure children receive appropriately tested medicines

Peer-Reviewed Publication

BMJ

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

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Children in Europe are being denied the same rights as adults in relation to receiving treatment with drugs that have been fully tested, report a team of European researchers in this week's BMJ. Unlicensed and "off label" drug prescribing in children is a problem across Europe that needs action conclude Sharon Conroy from the University of Nottingham and colleagues from Sweden, Germany, Italy and the Netherlands.

Many drugs are not tested in children, which means they are not specifically licensed for use in children, say the authors. However, because clinical trials of drugs are usually not performed on this age group, licensed drugs are often prescribed outside the terms of the product license in relation to age, dose, frequency or the intended use of the drug. Using licensed drugs in this manner renders them "off label". As a result, considerable concern exists within Europe and the United States about the use of unlicensed and off label drugs in children, report the team.

Conroy et al investigated the prescribing practices in the children's wards of five hospitals in Derby, Uppsala, Marburg, Bergamo and Rotterdam. They found that over a four week period during 1998, 2,262 drug prescriptions were administered to 624 children in the five hospitals. Almost half of all the drug prescriptions (1036) were either unlicensed or off label (872 were off label and 164 were unlicensed). This led to two thirds of the children (67 per cent) receiving an unlicensed or off label drug prescription during their stay in hospital. The most frequently prescribed off label drugs were those used in the treatment of asthma and pain relief, say the authors.

Conroy et al conclude that based on their findings, the use of off label or unlicensed drugs to treat children is widespread and that this problem is likely to affect children throughout Europe. They say that this requires action from the European Union, national departments of health and politicians as well as the European Medicines Evaluation Agency.

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Contact:

Professor Imti Choonara, Academic Division of Child Health (University of Nottingham), Derbyshire Children's Hospital, Derby

Tel: +44 (0)1332 625635 or 340131 or (0)1283 734778
Email: Imti.Choonara@nottingham.ac.uk


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