Arch Dis Child 2000;83:498-501 ( December )

Article

Unlicensed and off label prescribing of drugs in general practice J McIntyre^a, S Conroy^a, A Avery^b, H Corns^a, I Choonara^a

^a Academic Division of Child Health (University of Nottingham), Derbyshire Children's Hospital, Uttoxeter Road, Derby DE22 3NE, UK, ^b Division of General Practice, School of Community Health Sciences, University Hospital, Nottingham NG7 2UH, UK

Correspondence to: Dr McIntyre John.Mcintyre{at}nottingham.ac.uk

Accepted 13 July 2000

AIMTo determine the incidence and nature of unlicensed and off label prescribing of drugs for children in general practice.
METHODSA 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).
RESULTSDuring 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.
CONCLUSIONThis 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.


Keywords: unlicensed prescribing; off label prescribing; drugs; general practice

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© 2000 by Archives of Disease in Childhood
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