Off-label drug prescriptions in French general practice: a cross-sectional study.
Adolescent
Adult
Aged
Aged, 80 and over
Child
Child, Preschool
Cross-Sectional Studies
Drug Labeling
/ methods
Drug Prescriptions
/ statistics & numerical data
Female
France
General Practice
/ statistics & numerical data
Humans
Infant
Infant, Newborn
Male
Middle Aged
Off-Label Use
/ statistics & numerical data
Practice Patterns, Physicians'
/ statistics & numerical data
Retrospective Studies
Young Adult
drug prescription
general practice
off-label use
Journal
BMJ open
ISSN: 2044-6055
Titre abrégé: BMJ Open
Pays: England
ID NLM: 101552874
Informations de publication
Date de publication:
09 04 2019
09 04 2019
Historique:
entrez:
11
4
2019
pubmed:
11
4
2019
medline:
21
4
2020
Statut:
epublish
Résumé
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. 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. 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. 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). 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.
Identifiants
pubmed: 30967407
pii: bmjopen-2018-026076
doi: 10.1136/bmjopen-2018-026076
pmc: PMC6500201
doi:
Types de publication
Journal Article
Multicenter Study
Langues
eng
Sous-ensembles de citation
IM
Pagination
e026076Informations de copyright
© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
Déclaration de conflit d'intérêts
Competing interests: None declared.
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