Arch Dis Child 2000;83:502-505 ( December )

Article

Off label and unlicensed drug use among French office based paediatricians M Chalumeau^a, J M Tréluyer^a, B Salanave^b, R Assathiany^c, G Chéron^d, N Crocheton^e, C Rougeron^f, M Mares^g, G Bréart^b, G Pons^a

^a Pharmacologie Périnatale et Pédiatrique, Université René Descartes-Paris V, Hôpital Saint-Vincent de Paul, 82, avenue Denfert-Rochereau, 75674 Paris Cedex 14, France, ^b INSERM U149, Recherches Epidémiologiques sur la Santé des Femmes et des Enfants, Paris, France, ^c AREPEGE, Association pour la Recherche et l'Enseignement en Pédiatrie Générale, Versailles, France, ^d Centre d'Urgence et de Diagnostic Rapide, Hôpital Necker-Enfants Malades, Paris, France, ^e Urgences Médicales de Paris, Paris, France, ^f Faculté de Médecine Paris-Ouest, Garches, France, ^g Faculté de Médecine Necker-Enfants Malades, Paris, France

Correspondence to: Dr Pons gerard.pons{at}svp.ap-hop-paris.fr

Accepted 31 July 2000

AIMSTo determine the extent of off label and unlicensed drug use in French office based paediatric practice.
METHODSA prospective one day survey of all written prescriptions, for patients under 15 years, among 95 office based paediatricians in the Paris, France metropolitan area. Main outcome measures were: comparison of the use of each drug with its product licence for age, indication, dose, and route of administration.
RESULTSA total of 2522 prescriptions were administered to 989 patients; 844 (33%) were used either in an unlicensed (4%) or an off label (29%) manner. A total of 550 (56%) paediatric patients received one or more off label prescriptions.
CONCLUSIONSOff label prescriptions (that is, outside the terms of the Summary of Product Characteristics) are widespread in office based paediatric practice, while unlicensed drug use is rare in our study. New regulations in the licensing process in Europe are needed to allow children to receive drugs that have been fully evaluated in their specific age group.


Keywords: drug; approval; drug; utilisation; office visit; study; prospective

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© 2000 by Archives of Disease in Childhood
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