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BMJ. 2000 Jan 8;320(7227):79-82.

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

Author information

  • 1Academic Division of Child Health (University of Nottingham), Derbyshire Children's Hospital, Derby DE22 3NE.

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.

PMID:
10625257
[PubMed - indexed for MEDLINE]
PMCID:
PMC27251
Free PMC Article
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