Is it time for a European formulary of paediatric medicines?

The insufficient data leads to inevitable off-label or unlicensed drug use, which may entail a certain degree of risk for patients. 3 This unsatisfactory standing of children with regard to optimal drug therapy is well recognised, especially in the USA and Europe, but the situation in the latter has...

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Bibliographic Details
Published inArchives of disease in childhood Vol. 89; no. 9; pp. 890 - 891
Main Authors Bonati, M, Pandolfini, C
Format Journal Article
LanguageEnglish
Published England BMJ Publishing Group Ltd and Royal College of Paediatrics and Child Health 01.09.2004
BMJ Publishing Group LTD
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Summary:The insufficient data leads to inevitable off-label or unlicensed drug use, which may entail a certain degree of risk for patients. 3 This unsatisfactory standing of children with regard to optimal drug therapy is well recognised, especially in the USA and Europe, but the situation in the latter has been better defined through numerous studies. 4 Off-label/unlicensed prescription rates are in the range 23-62% in European paediatric hospital wards, 55-80% in neonatal intensive care units, and 11-49% in the community setting. 4 Wide differences in therapeutic approaches were found between and within settings and countries, suggesting the need for "harmonisation" in clinical practice.
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ObjectType-Correspondence-1
ISSN:0003-9888
1468-2044
DOI:10.1136/adc.2003.048025