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Abstract
Objectives Dextropropoxyphene (DXP), a step 2 analgesic commonly prescribed in France, was withdrawn from the French market in 2011 following a European decision due to its poor risk-benefit ratio.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.
Design Qualitative study based on 26 individual semi-structured interviews.
Setting Rhône-Alpes region of France.
Participants Thirteen patients and 13 GPs.
Methods 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.
Results 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.
Conclusions 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.
- dextropropoxyphene
- drug withdrawal
- general practitioner
- patient
- qualitative study
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Footnotes
AC and LB contributed equally.
Contributors LL, AC and LB conceived and designed the study, and they elaborated the interview guides. AC and LB conducted the interviews and the analysis, under the supervision of LL. EVG and FA provided clinical and pharmacoepidemiological context and contributed to the interpretation of the findings. LL, AC and LB drafted the manuscript. All authors reviewed and approved the final version of the article.
Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.
Competing interests None declared.
Patient consent Not required.
Ethics approval The study was approved by the Ethics Committee of the University of Lyon 1 (Lyon, France) and the French national agency for national data protection (CNIL, n°19162013). Before each interview, the interviewer informed the participant on the subject of the interview and asked for his/her oral consent to recording and analysing the data to be collected.
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement The data analysis tree is available on request from the corresponding author.