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Unlicensed and off label prescribing of drugs in general practice
J McIntyre1, S Conroy, A Avery
1Academic Division of Child Health (University of Nottingham), Derbyshire Children's Hospital, Uttoxeter Road, Derby DE22 3NE, UK. John.Mcintyre@nottingham.ac.uk
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.