Combier Aurélie, Bon Lucile, Van Ganse Eric, Aubrun Frédéric, Letrilliart Laurent
Collège universitaire de médecine générale, Université de Lyon, Université Claude Bernard Lyon 1, Université Saint-Étienne, Lyon, France.
Faculté d'odontologie, Université Claude-Bernard-Lyon 1, UMR CNRS 5558, Lyon, France.
BMJ Open. 2018 Sep 21;8(9):e021582. doi: 10.1136/bmjopen-2018-021582.
Dextropropoxyphene (DXP), a step 2 analgesic commonly prescribed in France, was withdrawn from the French market in 2011 following a European decision due to its poor risk-benefit ratio. The purpose of this study was to explore the perceptions of French general practitioners (GPs) and patients regarding DXP withdrawal.
Qualitative study based on 26 individual semi-structured interviews.
Rhône-Alpes region of France.
Thirteen patients and 13 GPs.
Interviews were conducted to collect data concerning the status of DXP, its efficacy and safety, the conditions of DXP's withdrawal and its potential impact. The transcripts were analysed using NVivo software.
DXP was a very popular drug among both patients and GPs. Its withdrawal was a bad experience for patients and many GPs; these misunderstood the reasons for its withdrawal and several contested them. They generally recognised more benefits than risks of DXP and considered alternative drugs unsatisfactory. In the same period, a French court case regarding another drug led to distrust towards the pharmaceutical industry and healthcare institutions, which contributed to the negative feelings reported. However, the experience was positive for the GPs who had been alerted to the poor DXP risk-benefit ratio well before its withdrawal.
Apart from physicians who were previously informed of its poor risk-benefit ratio, DXP withdrawal was not a good experience for patients and GPs. Better anticipation by the health authorities, in terms of pharmacoepidemiological surveillance and communication to healthcare professionals as well as the general public, should provide better acceptance of such a decision in the future.
右丙氧芬(DXP)是法国常用的二线镇痛药,2011年由于其风险效益比不佳,在欧洲作出决定后从法国市场撤出。本研究的目的是探讨法国全科医生(GP)和患者对右丙氧芬撤出的看法。
基于26次个人半结构化访谈的定性研究。
法国罗纳-阿尔卑斯地区。
13名患者和13名全科医生。
进行访谈以收集有关右丙氧芬的现状、疗效和安全性、撤出条件及其潜在影响的数据。使用NVivo软件对访谈记录进行分析。
右丙氧芬在患者和全科医生中都是一种非常受欢迎的药物。其撤出对患者和许多全科医生来说都是一次糟糕的经历;他们误解了撤出的原因,一些人对此提出质疑。他们普遍认为右丙氧芬的益处多于风险,并认为替代药物不尽人意。同一时期,法国一起关于另一种药物的法庭案件导致了对制药行业和医疗机构的不信任,这加剧了所报告的负面情绪。然而,对于那些在右丙氧芬撤出之前就已被提醒其风险效益比不佳的全科医生来说,这次经历是积极的。
除了那些事先了解到其风险效益比不佳的医生外,右丙氧芬的撤出对患者和全科医生来说都不是一次好的经历。卫生当局在药物流行病学监测以及与医疗专业人员和公众的沟通方面更好地做好准备,应该会使未来人们对这样的决定有更好的接受度。