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

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

S Conroy  1 , I Choonara, P Impicciatore, A Mohn, H Arnell, A Rane, C Knoeppel, H Seyberth, C Pandolfini, M P Raffaelli, F Rocchi, M Bonati, G Jong, M de Hoog, J van den Anker
Affiliations
Multicenter Study

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

S Conroy et al. BMJ. .

Abstract

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.

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References

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