Unlicensed and off label prescribing of drugs in general practice. Issue 6 (1st December 2000)

• Record Type: Journal Article
• Authors: McIntyre, J; Conroy, S; Avery, A; Corns, H; Choonara, I
• Is Part Of: Archives of disease in childhood. Volume 83:Issue 6(2000)
• Page Start: 498
• Page End: 501
• Publication Date: 2000-12-01
• Subjects: unlicensed prescribing -- off label prescribing -- drugs -- general practice; Children -- Diseases -- Periodicals; Infants -- Diseases -- Periodicals; 618.920005
• DOI: 10.1136/adc.83.6.498
• Languages: English
• ISSNs: 0003-9888

Abstract

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.