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Unlicensed and off‐label uses of drugs in paediatrics: a review of the literature
Author(s) -
Cuzzolin Laura,
Zaccaron Ada,
Fanos Vassilios
Publication year - 2003
Publication title -
fundamental and clinical pharmacology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.655
H-Index - 73
eISSN - 1472-8206
pISSN - 0767-3981
DOI - 10.1046/j.1472-8206.2003.00123.x
Subject(s) - license , off label use , action (physics) , medicine , drug , work (physics) , product (mathematics) , legal action , pediatrics , intensive care medicine , medical emergency , pharmacology , political science , engineering , law , physics , quantum mechanics , mechanical engineering , geometry , mathematics
The off‐label and unlicensed use of drugs to treat children is a common practice that occurs either in hospital or in the community. This derives from the fact that research for establishing drug efficacy and safety in children has not been carried out due to ethical problems, logistical difficulties, financial and legal concerns. In this work we report the studies available in literature documenting the extent of drug use in the paediatric field outside the recommendations of the license. From our analysis, a widespread attitude to prescribe medicines to children outside their product license either in the hospitals or in the community is confirmed. This suggests an immediate action for a more rationale use of drugs in paediatrics, to avoid exposing children and infants to unnecessary risks, but also to avoid depriving them of potentially effective and sometimes life‐saving therapies.