Skip to Main content Skip to Navigation
Master Thesis

Freins et motivations à l’application de la première RTU concernant la prescription de baclofène dans le traitement des troubles de l’usage de l’alcool par les médecins généralistes

Abstract : Temporary Recommendations for Use (TRU) are a unique framework created by a French law (2011) to regulate and ensure a better safety for some off-label prescriptions. This measure was first applied to baclofen, widely prescribed off-label for treatment of alcohol use disorders by general practitioners since 2008. This off-label prescription involves over 10 000 prescribers and 100 000 patients. A TRU was thereby created to frame this prescription in March 2014, but one year later only 5000 patients were enrolled. Using qualitative research, we have studied the obstacles and incentives for the application of this TRU. We interviewed individually 15 general practitioners about their experience with the TRU. The main obstacles were the complexity of the TRU in everyday practice, and the lack of information, even though prescribers often wanted to participate to pharmacovigilance or to support baclofen. Some practitioners were suspicious and anxious, and considered the TRU a method of surveillance ; but generally the idea of regulating off-label drug use was thought necessary. This results in a non or incomplete application of the TRU. A revision of the TRU including its simplification is planned while waiting for a probable drug approval in the future.
Document type :
Master Thesis
Complete list of metadatas

Cited literature [81 references]  Display  Hide  Download

https://dumas.ccsd.cnrs.fr/dumas-01508629
Contributor : Université Paris Descartes - Scd <>
Submitted on : Friday, April 14, 2017 - 1:24:46 PM
Last modification on : Friday, March 27, 2020 - 2:32:42 AM
Long-term archiving on: : Saturday, July 15, 2017 - 3:46:13 PM

Identifiers

  • HAL Id : dumas-01508629, version 1

Citation

Valérie Barrois. Freins et motivations à l’application de la première RTU concernant la prescription de baclofène dans le traitement des troubles de l’usage de l’alcool par les médecins généralistes. Médecine humaine et pathologie. 2016. ⟨dumas-01508629⟩

Share

Metrics

Record views

89

Files downloads

632