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Arch Dis Child. 2000 Dec;83(6):498-501.

Unlicensed and off label prescribing of drugs in general practice.

Author information

  • 1Academic Division of Child Health (University of Nottingham), Derbyshire Children's Hospital, Uttoxeter Road, Derby DE22 3NE, UK. John.Mcintyre@nottingham.ac.uk

Abstract

AIM:

To determine the incidence and nature of unlicensed and off label prescribing of drugs for children in general practice.

METHODS:

A retrospective analysis of all prescriptions for one year involving children (aged 12 years or under) from a single suburban general practice in the English Midlands. Prescribed drugs were categorised as licensed, unlicensed (without a product licence), or used in an off label way (outside the terms of their product licence).

RESULTS:

During 1997 there were 3347 prescription items involving 1175 children and 160 different drugs. A total of 2828 (84. 5%) prescriptions were for licensed medicines used in a licensed way; 10 (0.3%) were for unlicensed medicines; and 351 (10.5%) were licensed medicines used in an off label way. For 158 (4.7%) the information was insufficient to determine licence status.

CONCLUSION:

This is the first study to show that a significant number of drugs prescribed for children by general practitioners are off label and highlights the anomalies and inadequacies of drug information for prescribers.

PMID:
11087285
[PubMed - indexed for MEDLINE]
PMCID:
PMC1718565
Free PMC Article
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