BMJ 2002;324:1313-1314 ( 1 June )

Primary care

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

Editorial by Banner and pp 1311, 1312

Geert W `t Jong, researcher ^a, Ingo A Eland, researcher ^b, Miriam C J M Sturkenboom, assistant professor of pharmaco-epidemiology ^c, John N van den Anker, professor of pediatrics ^d, Bruno H Ch Stricker, professor of pharmaco-epidemiology ^b. 

^a Department of Paediatrics, Sophia Children's Hospital, Erasmus Medical Center Rotterdam, PO Box 1738, 3000 DR Rotterdam, Netherlands, ^b Pharmaco-epidemiology Unit, Departments of Epidemiology & Biostatistics and Internal Medicine, Erasmus Medical Center Rotterdam, ^c Departments of Epidemiology & Biostatistics and Medical Informatics, Erasmus Medical Center Rotterdam, ^d Department of Pediatrics, Ohio State University, Columbus, OH 43210, USA

Correspondence to: B H Ch Stricker stricker@epib.fgg.eur.nl

The first 150 words of the full text of this article appear below.

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.

	Methods and results

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, we conducted a one year population based cohort study. From a source population of 53 702 eligible children, we randomly sampled 25% (n=13 426; . . . [Full text of this article]

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