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. 2000 Dec;83(6):498-501.
doi: 10.1136/adc.83.6.498.

Unlicensed and off label prescribing of drugs in general practice

J McIntyre  1 , S Conroy, A Avery, H Corns, I Choonara
Affiliations

Unlicensed and off label prescribing of drugs in general practice

J McIntyre et al. Arch Dis Child. 2000 Dec.

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.

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