Off-label baclofen prescribing practices among French alcohol specialists: results of a national online survey.

<h4>Objective</h4>To evaluate, among alcohol specialists belonging to the Société Française d'Alcoologie (SFA), i.e., the French Alcohol Society, the proportion of physicians who prescribed off-label baclofen for alcohol use disorders (AUDs). The secondary objective was to depict th...

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Autores principales:	Benjamin Rolland, François Paille, Benoit Fleury, Olivier Cottencin, Amine Benyamina, Henri-Jean Aubin
Formato:	article
Lenguaje:	EN
Publicado:	Public Library of Science (PLoS) 2014
Materias:	Medicine R Science Q
Acceso en línea:	https://doaj.org/article/ba7c29eb87f442289d97e4b3eb976981
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spelling	oai:doaj.org-article:ba7c29eb87f442289d97e4b3eb9769812021-11-18T08:17:38ZOff-label baclofen prescribing practices among French alcohol specialists: results of a national online survey.1932-620310.1371/journal.pone.0098062https://doaj.org/article/ba7c29eb87f442289d97e4b3eb9769812014-01-01T00:00:00Zhttps://www.ncbi.nlm.nih.gov/pmc/articles/pmid/24887094/?tool=EBIhttps://doaj.org/toc/1932-6203<h4>Objective</h4>To evaluate, among alcohol specialists belonging to the Société Française d'Alcoologie (SFA), i.e., the French Alcohol Society, the proportion of physicians who prescribed off-label baclofen for alcohol use disorders (AUDs). The secondary objective was to depict the features of individual prescribing and monitoring practices.<h4>Methods</h4>On-line survey among 484 French alcohol specialists. Physicians were asked whether they prescribed baclofen for AUDs. If they did not, the reasons for this choice were investigated. If they did, the features of the physician's prescribing practice were explored, including the number of patients treated, the mean and maximum doses, the monitoring precautions and the pharmacovigilance reporting. Participants were also asked about their empirical findings on HDB's efficacy and safety.<h4>Results</h4>In total, 302 physicians (response rate of 62.4%) participated in the survey. Data from 296 participants were analysed, representing 59.4% of all active prescribing physicians belonging to the SFA. HDB use was declared by 74.6% of participants (mean dose 109.5 ± 43.6 mg/d; maximum dose 188 ± 93.3 mg/d). However, 79.2% of prescribers had treated less than 30 patients, and 67.8% used HDB as a second-line medication. Although HDB was perceived as more efficacious than approved drugs by 54.3% of prescribers, it was also declared less safe by 62.8%. Nonetheless, 79.7% of prescribers had never filed any pharmacovigilance report. Non-prescribers (25.6%) were primarily deterred by the current lack of scientific data and official regulation.<h4>Conclusion</h4>A majority of French alcohol specialists reported using HDB, although often on a limited number of their patients. HDB was considered efficacious but also potentially hazardous. Despite this, physicians reported minimal safety data to the health security system. While French health authorities are planning to draft a specific regulatory measure for framing off-label HDB prescribing practices, the sustained education of prescribers on spontaneous pharmacovigilance reporting should be enhanced.Benjamin RollandFrançois PailleBenoit FleuryOlivier CottencinAmine BenyaminaHenri-Jean AubinPublic Library of Science (PLoS)articleMedicineRScienceQENPLoS ONE, Vol 9, Iss 6, p e98062 (2014)
institution	DOAJ
collection	DOAJ
language	EN
topic	Medicine R Science Q
spellingShingle	Medicine R Science Q Benjamin Rolland François Paille Benoit Fleury Olivier Cottencin Amine Benyamina Henri-Jean Aubin Off-label baclofen prescribing practices among French alcohol specialists: results of a national online survey.
description	<h4>Objective</h4>To evaluate, among alcohol specialists belonging to the Société Française d'Alcoologie (SFA), i.e., the French Alcohol Society, the proportion of physicians who prescribed off-label baclofen for alcohol use disorders (AUDs). The secondary objective was to depict the features of individual prescribing and monitoring practices.<h4>Methods</h4>On-line survey among 484 French alcohol specialists. Physicians were asked whether they prescribed baclofen for AUDs. If they did not, the reasons for this choice were investigated. If they did, the features of the physician's prescribing practice were explored, including the number of patients treated, the mean and maximum doses, the monitoring precautions and the pharmacovigilance reporting. Participants were also asked about their empirical findings on HDB's efficacy and safety.<h4>Results</h4>In total, 302 physicians (response rate of 62.4%) participated in the survey. Data from 296 participants were analysed, representing 59.4% of all active prescribing physicians belonging to the SFA. HDB use was declared by 74.6% of participants (mean dose 109.5 ± 43.6 mg/d; maximum dose 188 ± 93.3 mg/d). However, 79.2% of prescribers had treated less than 30 patients, and 67.8% used HDB as a second-line medication. Although HDB was perceived as more efficacious than approved drugs by 54.3% of prescribers, it was also declared less safe by 62.8%. Nonetheless, 79.7% of prescribers had never filed any pharmacovigilance report. Non-prescribers (25.6%) were primarily deterred by the current lack of scientific data and official regulation.<h4>Conclusion</h4>A majority of French alcohol specialists reported using HDB, although often on a limited number of their patients. HDB was considered efficacious but also potentially hazardous. Despite this, physicians reported minimal safety data to the health security system. While French health authorities are planning to draft a specific regulatory measure for framing off-label HDB prescribing practices, the sustained education of prescribers on spontaneous pharmacovigilance reporting should be enhanced.
format	article
author	Benjamin Rolland François Paille Benoit Fleury Olivier Cottencin Amine Benyamina Henri-Jean Aubin
author_facet	Benjamin Rolland François Paille Benoit Fleury Olivier Cottencin Amine Benyamina Henri-Jean Aubin
author_sort	Benjamin Rolland
title	Off-label baclofen prescribing practices among French alcohol specialists: results of a national online survey.
title_short	Off-label baclofen prescribing practices among French alcohol specialists: results of a national online survey.
title_full	Off-label baclofen prescribing practices among French alcohol specialists: results of a national online survey.
title_fullStr	Off-label baclofen prescribing practices among French alcohol specialists: results of a national online survey.
title_full_unstemmed	Off-label baclofen prescribing practices among French alcohol specialists: results of a national online survey.
title_sort	off-label baclofen prescribing practices among french alcohol specialists: results of a national online survey.
publisher	Public Library of Science (PLoS)
publishDate	2014
url	https://doaj.org/article/ba7c29eb87f442289d97e4b3eb976981
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Off-label baclofen prescribing practices among French alcohol specialists: results of a national online survey.

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