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Article Dans Une Revue BMJ Open Année : 2019

Off-label drug prescriptions in French general practice: a cross-sectional study

François Drogou
  • Fonction : Auteur
Allison Netboute
  • Fonction : Auteur
Xavier Dode
  • Fonction : Auteur
David Darmon
  • Fonction : Auteur
Behrouz Kassai
Laurent Letrilliart
  • Fonction : Auteur

Résumé

Objectives Off-label drug prescribing is a public health and economic issue. The aim of this study was to describe off-label prescription in general practice in France, in terms of frequency and nature, and to identify its main determining factors. Design Multicentre cross-sectional study Setting Twenty-three training general practice offices Participants All the voluntary patients coming for a medical consultation or visited at home over a cumulative period of 5 days per office between November 2015 and January 2016. Methods Eleven interns, acting as observers, collected data. Two reviewers analysed the drugs prescribed by the trainers, in order to identify those prescribed off-label in terms of their indication or the age of the patient. We used a univariate, then a multivariate model, based on hierarchical mixed-effects logistic regression. Results Among the 4932 drug prescriptions registered, 911 (18.5%[95% CI17.4% to 19.6%]) were off-label, of which 865 (17.6%) due to the indication of the drug and 58 (1.2%) due to the age of the patient. The prescription never mentioned the off-label use, neither was the patient informed of it, as required by the French law. With the multivariate analysis, variables contributing to off-label prescription were the number of drugs (OR=1.05 for each additional drug), the initiation of new drug therapy (OR=1.26) and the non-specific goal of the prescription (OR=1.43); the age of the patient ≤14 years (OR=1.42); the rural location of the physician’s practice (OR=1.38) and the low frequency of the visits of national health insurance representatives (OR=0.93). Conclusion Almost one out of five drugs prescribed in French general practice was off-label. It seems necessary to better train physicians in clinical pharmacology, to provide them with more effective drug prescription software, to reinforce postmarketing surveillance and to clearly define off-label use by consensus.
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Dates et versions

hal-03836889 , version 1 (23-01-2024)

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François Drogou, Allison Netboute, Joris Giai, Xavier Dode, David Darmon, et al.. Off-label drug prescriptions in French general practice: a cross-sectional study. BMJ Open, 2019, 9 (4), pp.e026076. ⟨10.1136/bmjopen-2018-026076⟩. ⟨hal-03836889⟩
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