Unlicensed and off-label uses of drugs in paediatrics: a review of the literature.
Fundam Clin Pharmacol
; 17(1): 125-31, 2003 Feb.
Article
em En
| MEDLINE
| ID: mdl-12588640
ABSTRACT
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.
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Base de dados:
MEDLINE
Assunto principal:
Aprovação de Drogas
/
Revisão de Uso de Medicamentos
/
Rotulagem de Medicamentos
Tipo de estudo:
Guideline
Limite:
Child
/
Humans
Idioma:
En
Revista:
Fundam Clin Pharmacol
Assunto da revista:
FARMACOLOGIA
Ano de publicação:
2003
Tipo de documento:
Article
País de afiliação:
Itália