Unlicensed and off-label drug use in a Swiss paediatric university hospital.

Détails

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Etat: Serval
Version: Final published version
ID Serval
serval:BIB_CCC5CB681680
Type
Article: article d'un périodique ou d'un magazine.
Collection
Publications
Titre
Unlicensed and off-label drug use in a Swiss paediatric university hospital.
Périodique
Swiss Medical Weekly
Auteur(s)
Di Paolo E.R., Stoetter H., Cotting J., Frey P., Gehri M., Beck-Popovic M., Tolsa J.F., Fanconi S., Pannatier A.
ISSN
1424-7860
Statut éditorial
Publié
Date de publication
2006
Peer-reviewed
Oui
Volume
136
Numéro
13-14
Pages
218-222
Langue
anglais
Résumé
BACKGROUND: Many medicines used in newborns, infants, children and adolescents are not licensed ("unlicensed") or are prescribed outside the terms of the marketing authorization ("off-label"). Several studies have shown that this is a common practice in various healthcare settings in the USA, Europe and Australia, but data are scarce in Switzerland. OBJECTIVES: The aim of our prospective study was to determine the proportion of unlicensed or off-label prescriptions in paediatric patients. METHODS: This pilot study was conducted prospectively over a six month period in the department of paediatrics of a university hospital. RESULTS: Sixty patients aged from three days to 14 years were included in the study. A total of 483 prescriptions were written for the patients. More than half of all prescriptions (247; 51%) followed the terms of the marketing authorization. 114 (24%) were unlicensed and 122 (25%) off-label. All patients received at least one unlicensed or offlabel medicine. CONCLUSION: The use of unlicensed or off-label medicines to treat children was found to be common. Co-operation between the pharmaceutical industry, national regulatory authorities, clinical researchers, healthcare professionals and parents is required in order to ensure that children do not remain "therapeutic orphans".
Mots-clé
Adolescent, Child, Child, Preschool, Drug Approval, Drug Labeling, Female, Hospitals, Pediatric, Hospitals, University, Humans, Infant, Infant, Newborn, Male, Pharmaceutical Preparations, Physician's Practice Patterns, Pilot Projects, Prospective Studies, Switzerland
Pubmed
Web of science
Création de la notice
20/03/2008 10:34
Dernière modification de la notice
15/06/2018 15:08
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