Unlicensed and off label prescription of drugs to children: population based cohort study

Abstract

Editorial by Banner and pp 1311, 1312 Drugs are subject to licensing procedures to ensure their quality, efficacy, and safety, but many drugs used to treat children in hospital are either not licensed for use in children (“unlicensed”) or are prescribed outside the terms of the product licence (“off label”).1 Little is known about such prescribing in general practice, so we conducted a cohort study in primary care in the Netherlands to investigate the subject. We retrieved data from the integrated primary care information project, a longitudinal observational database containing information from computer based patient records of 150 general practitioners in the Netherlands. The system complies with European Union guidelines on the use of medical data for medical research and has been proved valid for pharmacoepidemiological research.2 Within the dynamic population of children (0-16 years) registered in 1998, …