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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