Unlicensed and off label prescribing of drugs in general practice

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.