Healthy Skepticism Library item: 11617

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Publication type: Journal Article

Waller DG.
Off-label and unlicensed prescribing for children: have we made any progress?
Br J Clin Pharmacol 2007 Jul; 64:(1):1-2
http://www.blackwell-synergy.com/doi/full/10.1111/j.1365-2125.2007.02987.x

Abstract:

Unlicensed drugs are those that do not have marketing authorization. Off-label use is prescribing outside the terms of the product licence, for example in a different indication, age group, dose or route to that which is approved by the regulatory authority. In 1999, Collier wrote an editorial for the Journal, in which he considered the problems raised by off-label and unlicensed prescribing for children. He concluded that “the current widespread use of products outside [licensed] conditions disadvantages children and is unacceptable” (1). Has anything changed over the last 8 years? Data from the UK suggest that in primary care about 11% of drugs prescribed for children are used off label (2). Higher figures have been found in the Netherlands (29%) (3) and France (33%) (4). The rate of off-label use for children in hospital was close to 40% in a survey of five European hospitals (5) and even higher in hospitalized neonates…

Keywords:
MeSH Terms: Child Child, Preschool Drug Approval/legislation & jurisprudence* Drug Information Services Drug Labeling/legislation & jurisprudence* Drug Therapy/adverse effects* Drug Utilization Great Britain Humans Infant Infant, Newborn Physician's Practice Patterns* Prescriptions, Drug Risk

Notes:

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