Dataset Information

Association between gifts from pharmaceutical companies to French general practitioners and their drug prescribing patterns in 2016: retrospective study using the French Transparency in Healthcare and National Health Data System databases.

ABSTRACT: OBJECTIVE:To evaluate the association between gifts from pharmaceutical companies to French general practitioners (GPs) and their drug prescribing patterns. DESIGN:Retrospective study using data from two French databases (National Health Data System, managed by the French National Health Insurance system, and Transparency in Healthcare). SETTING:Primary care, France. PARTICIPANTS:41?257 GPs who in 2016 worked exclusively in the private sector and had at least five registered patients. The GPs were divided into six groups according to the monetary value of the received gifts reported by pharmaceutical, medical device, and other health related companies in the Transparency in Healthcare database. MAIN OUTCOME MEASURES:The main outcome measures were the amount reimbursed by the French National Health Insurance for drug prescriptions per visit (to the practice or at home) and 11 drug prescription efficiency indicators used by the National Health Insurance to calculate the performance related financial incentives of the doctors. Doctor and patient characteristics were used as adjustment variables. The significance threshold was 0.001 for statistical analyses. RESULTS:The amount reimbursed by the National Health Insurance for drug prescriptions per visit was lower in the GP group with no gifts reported in the Transparency in Healthcare database in 2016 and since its launch in 2013 (no gift group) compared with the GP groups with at least one gift in 2016 (-€5.33 (99.9% confidence interval -€6.99 to -€3.66) compared with the GP group with gifts valued at €1000 or more reported in 2016) (P<0.001). The no gift group also more frequently prescribed generic antibiotics (2.17%, 1.47% to 2.88% compared with the ?€1000 group), antihypertensives (4.24%, 3.72% to 4.77% compared with the ?€1000 group), and statins (12.14%, 11.03% to 13.26% compared with the ?€1000 group) than GPs with at least one gift between 2013 and 2016 (P<0.001). The no gift group also prescribed fewer benzodiazepines for more than 12 weeks (-0.68%, -1.13% to -0.23% compared with the €240-€999 group) and vasodilators (-0.15%, -0.28% to -0.03% compared with the ?€1000 group) than GPs with gifts valued at €240 or more reported in 2016, and more angiotensin converting enzyme (ACE) inhibitors compared with all ACE and sartan prescriptions (1.67%, 0.62% to 2.71%) compared with GPs with gifts valued at €1000 or more reported in 2016 (P<0.001). Differences were not significant for the prescription of aspirin and generic antidepressants and generic proton pump inhibitors. CONCLUSION:The findings suggest that French GPs who do not receive gifts from pharmaceutical companies have better drug prescription efficiency indicators and less costly drug prescriptions than GPs who receive gifts. This observational study is susceptible to residual confounding and therefore no causal relation can be concluded. TRIAL REGISTRATION:OSF register OSF.IO/8M3QR.

SUBMITTER: Goupil B

PROVIDER: S-EPMC6830500 | biostudies-literature | 2019 Nov

REPOSITORIES: biostudies-literature

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Association between gifts from pharmaceutical companies to French general practitioners and their drug prescribing patterns in 2016: retrospective study using the French Transparency in Healthcare and National Health Data System databases.

Goupil Bruno B Balusson Frédéric F Naudet Florian F Esvan Maxime M Bastian Benjamin B Chapron Anthony A Frouard Pierre P

BMJ (Clinical research ed.) 20191105

<h4>Objective</h4>To evaluate the association between gifts from pharmaceutical companies to French general practitioners (GPs) and their drug prescribing patterns.<h4>Design</h4>Retrospective study using data from two French databases (National Health Data System, managed by the French National Health Insurance system, and Transparency in Healthcare).<h4>Setting</h4>Primary care, France.<h4>Participants</h4>41 257 GPs who in 2016 worked exclusively in the private sector and had at least five re ...[more]

PMID: 31690553

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Project description:BackgroundDrug companies rely on their marketing activities to influence physicians. Previous studies showed that pharmaceutical companies succeeded to manage physicians prescribing behavior in developed countries. However, very little studies investigated the impact of pharmaceutical marketing strategies on prescribing pattern in developing countries, middle-eastern countries. The objective of this research was to examine the influence of drug companies' strategies on physicians' prescription behavior in the Lebanese market concerning physicians' demographic variables quantitatively. Moreover, this study tested whether Lebanese physicians considered gifts and samples acceptance as an ethical practice.MethodsSampling was done by using a non-probability method. An online cross-sectional study was conducted through WhatsApp. A self-administered questionnaire survey was conducted during the months of February and March 2018. Cronbach's Alpha reliability coefficient was calculated. Data were statistically analyzed by using IBM SPSS statistics version 24 software. Chi-square and Cramer's v tests were used to finding sign correlation, and Spearman test was used to measure the strength and direction of a relationship between variables.ResultsResults found that pharmaceutical marketing strategies are correlated to physicians' prescribing behavior. We demonstrated that the majority of the promotional tools tested were mostly or sometimes motivating physicians to prescribe promoted drugs. The major tools that physicians agreed to be mostly motivated by are visits of medical representatives and drug samples while sales calls made by pharmaceutical companies are the less influential tool. Regarding gift acceptance, this study demonstrated that physicians consider gifts' acceptance as a non-ethical practice. Results showed that most physicians use free samples to treat their patients. We demonstrated that there is a relationship between physicians' prescribing pattern and their age, gender and the location of practice.ConclusionsFindings of this study provided an insightful work, serving as one of the first humble steps in the imminent direction of merging this paper with the previous literature. From a managerial perspective, pharmaceutical marketing managers of drug companies can use the research findings to design better their strategies directed to the Lebanese physicians who can also benefit from the results obtained.

Project description:OBJECTIVES:To define a series of clinical trial transparency measures and apply them to large pharmaceutical and biotechnology companies and their 2014 FDA-approved drugs. DESIGN:Cross-sectional descriptive analysis of all clinical trials supporting 2014 Food and Drugs Administration (FDA)-approved new drug applications (NDAs) for novel drugs sponsored by large companies. DATA SOURCES:Data from over 45 sources, including Drugs@FDA.gov, ClinicalTrials.gov, corporate and international registries; PubMed, Google Scholar, EMBASE, corporate press releases, Securities and Exchange Commission (SEC) filings and personal communications with drug manufacturers. OUTCOME MEASURES:Trial registration, results reporting, clinical study report (CSR) synopsis sharing, biomedical journal publication, and FDA Amendments Acts (FDAAA) compliance, analysed on the drug level. RESULTS:The FDA approved 19 novel new drugs, sponsored by 11 large companies, involving 553 trials, in 2014. We analysed 505 relevant trials. Per drug, a median of 100% (IQR 86%-100%) of trials in patients were registered, 71% (IQR 57%-100%) reported results or shared a CSR synopsis, 80% (70%-100%) were published and 96% (80%-100%) were publicly available in some form by 13 months after FDA approval. Disclosure rates were lower at FDA approval (65%) and improved significantly by 6 months post FDA approval. Per drug, a median of 100% (IQR 75%-100%) of FDAAA-applicable trials were compliant. Half of reviewed drugs had publicly disclosed results for all trials in patients in our sample. One trial was uniquely registered in a corporate registry, and not ClinicalTrials.gov; 0 trials were uniquely registered in international registries. CONCLUSIONS:Among large pharmaceutical companies and new drugs, clinical trial transparency is high based on several standards, although opportunities for improvement remain. Transparency is markedly higher for trials in patients than among all trials supporting drug approval, including trials in healthy volunteers. Ongoing efforts to publicly track companies' transparency records and recognise exemplary companies may encourage further progress.

Project description:We aimed to evaluate the prevalence of burnout among French general practitioners in private practice and to study the risk and protective factors of burnout. A nationwide cross-sectional study was conducted with French GPs working in a private practice in France who were asked to fulfil an internet questionnaire. We used the secure internet application REDCap®. Exclusion criteria were only working in a hospital, substitute doctors, and internship students. There was a putative sample size of 88,886 GPs. We retrieved the Maslach Burnout Inventory (MBI), occupational characteristics (type of installation, emergency regulated shifts, night shifts, university supervisor, weekly hours worked, seniority), and personal characteristics such as age, gender, marital status, and number of children. We included 1926 GPs among the 2602 retrieved questionnaires. A total of 44.8% of French liberal GPs were experiencing burnout, with 4.8% (95%CI 3.9-5.9%) experiencing severe burnout. The risk factors of severe burnout were male gender (RR = 1.91, 95%CI 1.15-3.16), working in a suburban area (5.23, 2.18-12.58), and having more than 28 appointments per day (1.95, 1.19-3.19). Working more than 50 h weekly showed a tendency to increase the risk of severe burnout (1.55, 0.93-2.59, p = 0.095), with a significant increase in the risk of low and moderate burnout (1.31, 1.02-1.67 and 1.86, 1.34-2.57, respectively). Protective factors were mainly resident training, which decreased the risk of both low, moderate, and severe burnout (0.65, 0.51-0.83; 0.66, 0.48-0.92; and 0.42, 95%CI 0.23-0.76, respectively). Performing home visits decreased the risk of severe burnout (0.25, 0.13-0.47), as did group practice for intermediate level of burnout (0.71, 0.51-0.96). GPs are at a high risk of burnout, with nearly half of them in burnout, with burnout predominantly affecting males and those between the ages of 50 and 60 years old. The main risk factors were a high workload with more than 28 appointments per day or 50 h of work per week, and the main protective factors were related to social cohesion such having a teaching role and working in a group practice with back-office support.

Project description:BackgroundPharmaceutical companies spent $57.5 billion on pharmaceutical promotion in the United States in 2004. The industry claims that promotion provides scientific and educational information to physicians. While some evidence indicates that promotion may adversely influence prescribing, physicians hold a wide range of views about pharmaceutical promotion. The objective of this review is to examine the relationship between exposure to information from pharmaceutical companies and the quality, quantity, and cost of physicians' prescribing.Methods and findingsWe searched for studies of physicians with prescribing rights who were exposed to information from pharmaceutical companies (promotional or otherwise). Exposures included pharmaceutical sales representative visits, journal advertisements, attendance at pharmaceutical sponsored meetings, mailed information, prescribing software, and participation in sponsored clinical trials. The outcomes measured were quality, quantity, and cost of physicians' prescribing. We searched Medline (1966 to February 2008), International Pharmaceutical Abstracts (1970 to February 2008), Embase (1997 to February 2008), Current Contents (2001 to 2008), and Central (The Cochrane Library Issue 3, 2007) using the search terms developed with an expert librarian. Additionally, we reviewed reference lists and contacted experts and pharmaceutical companies for information. Randomized and observational studies evaluating information from pharmaceutical companies and measures of physicians' prescribing were independently appraised for methodological quality by two authors. Studies were excluded where insufficient study information precluded appraisal. The full text of 255 articles was retrieved from electronic databases (7,185 studies) and other sources (138 studies). Articles were then excluded because they did not fulfil inclusion criteria (179) or quality appraisal criteria (18), leaving 58 included studies with 87 distinct analyses. Data were extracted independently by two authors and a narrative synthesis performed following the MOOSE guidelines. Of the set of studies examining prescribing quality outcomes, five found associations between exposure to pharmaceutical company information and lower quality prescribing, four did not detect an association, and one found associations with lower and higher quality prescribing. 38 included studies found associations between exposure and higher frequency of prescribing and 13 did not detect an association. Five included studies found evidence for association with higher costs, four found no association, and one found an association with lower costs. The narrative synthesis finding of variable results was supported by a meta-analysis of studies of prescribing frequency that found significant heterogeneity. The observational nature of most included studies is the main limitation of this review.ConclusionsWith rare exceptions, studies of exposure to information provided directly by pharmaceutical companies have found associations with higher prescribing frequency, higher costs, or lower prescribing quality or have not found significant associations. We did not find evidence of net improvements in prescribing, but the available literature does not exclude the possibility that prescribing may sometimes be improved. Still, we recommend that practitioners follow the precautionary principle and thus avoid exposure to information from pharmaceutical companies. Please see later in the article for the Editors' Summary.

Project description:ObjectivesTo investigate German physicians' attitudes towards and experiences with voluntary disclosure of payments by pharmaceutical companies in a public database and their impact on future decisions for or against disclosure.DesignA national cross-sectional survey conducted in 2018 among physicians who voluntarily disclosed at least one payment in the German transparency regulation.SettingRetrospective paper-pencil questionnaire about attitudes towards and experiences with voluntary payment disclosures in the first (2015) and second (2016) years of the German transparency regulation.ParticipantsGerman physicians who disclosed either in the first year only, the second year only, or in both years of the transparency regulation.Primary outcomes(1) The probability to disclose in 2016, predicted by physicians' experience of reactions from others in 2015, descriptive norms and attitudes towards transparency; (2) Frequency and (3) Content of reactions from others in 2015 compared with 2016.ResultsData of 234 respondents were analysed (n=42, 45 and 147 physicians who disclosed in 2015, 2016 or both years, respectively). The probability to disclose in 2016 was not predicted by perceived reactions, norms or attitudes towards transparency (p>0.01). Most participants reported not to have received any reactions by patients (190/234, 81%), colleagues (128/234, 55%) or the private environment (153/234, 65%). Neither frequency nor content of reactions differed between the first and second years (scale 1-5; frequency: Mdn 2015,2016 = 1.33 vs 1.00, r b=-0.17, p>0.01; content: Mdn 2015,2016 = 3.00 vs 3.00, r b=0.19, p>0.01). However, media reporting, fear of reputational damage and a feeling of being defamed were mentioned as reasons for non-disclosure.ConclusionsWhile confirmatory analyses did not provide significant results, descriptive analyses showed that participants who voluntarily disclose payments mainly do not experience any reactions towards their disclosures but report fears about losing their reputation due to disclosures.

Project description:BackgroundAustralian and international guidelines recommend benzodiazepines and related drugs (hereafter "benzodiazepines") as second-line, short-term medications only. Most benzodiazepines are prescribed by general practitioners (GPs; family physicians). Australian GP registrars ("trainees" or "residents" participating in a post-hospital training, apprenticeship-like, practice-based vocational training program), like senior GPs, prescribe benzodiazepines at high rates. Education within a training program, and experience in general practice, would be expected to reduce benzodiazepine prescribing.ObjectiveTo establish if registrars' prescribing of benzodiazepines decreases with time within a GP training program DESIGN: Longitudinal analysis from the Registrar Clinical Encounters in Training multi-site cohort study PARTICIPANTS: Registrars of five of Australia's 17 Regional Training Providers. Analyses were restricted to patients ??16 years.Main measuresThe main outcome factor was prescription of a benzodiazepine. Conditional logistic regression was used, with registrar included as a fixed effect, to assess within-registrar changes in benzodiazepine-prescribing rates. The "time" predictor variable was "training term" (6-month duration Terms 1-4). To contextualize these "within-registrar" changes, a mixed effects logistic regression model was used, including a random effect for registrar, to assess within-program changes in benzodiazepine-prescribing rates over time. The "time" predictor variable was "year" (2010-2015).Key resultsOver 12 terms of data collection, 2010-2015, 1161 registrars (response rate 96%) provided data on 136,809 face-to-face office-based consultations. Two thousand six hundred thirty-two benzodiazepines were prescribed (for 1.2% of all problems managed). In the multivariable model, there was a significant reduction in within-program benzodiazepine prescribing over time (year) (p?=?<?0.001, OR?=?0.94, CI?=?0.90, 0.97). However, there was no significant change in 'within-registrar' prescribing over time (registrar Term) (p?=?0.92, OR?=?1.00 [95% CI?=?0.94-1.06]).ConclusionsDespite a welcome temporal trend for reductions in overall benzodiazepine prescribing from 2010 to 2015, there is still room for improvement and our findings suggest a lack of effect of specific GP vocational training program education and, thus, an opportunity for targeted education.

Project description:Importance:Understanding the profitability of pharmaceutical companies is essential to formulating evidence-based policies to reduce drug costs while maintaining the industry's ability to innovate and provide essential medicines. Objective:To compare the profitability of large pharmaceutical companies with other large companies. Design, Setting, and Participants:This cross-sectional study compared the annual profits of 35 large pharmaceutical companies with 357 companies in the S&P 500 Index from 2000 to 2018 using information from annual financial reports. A statistically significant differential profit margin favoring pharmaceutical companies was evidence of greater profitability. Exposures:Large pharmaceutical vs nonpharmaceutical companies. Main Outcomes and Measures:The main outcomes were revenue and 3 measures of annual profit: gross profit (revenue minus the cost of goods sold); earnings before interest, taxes, depreciation, and amortization (EBITDA; pretax profit from core business activities); and net income, also referred to as earnings (difference between all revenues and expenses). Profit measures are described as cumulative for all companies from 2000 to 2018 or annual profit as a fraction of revenue (margin). Results:From 2000 to 2018, 35 large pharmaceutical companies reported cumulative revenue of $11.5 trillion, gross profit of $8.6 trillion, EBITDA of $3.7 trillion, and net income of $1.9 trillion, while 357 S&P 500 companies reported cumulative revenue of $130.5 trillion, gross profit of $42.1 trillion, EBITDA of $22.8 trillion, and net income of $9.4 trillion. In bivariable regression models, the median annual profit margins of pharmaceutical companies were significantly greater than those of S&P 500 companies (gross profit margin: 76.5% vs 37.4%; difference, 39.1% [95% CI, 32.5%-45.7%]; P?<?.001; EBITDA margin: 29.4% vs 19%; difference, 10.4% [95% CI, 7.1%-13.7%]; P?<?.001; net income margin: 13.8% vs 7.7%; difference, 6.1% [95% CI, 2.5%-9.7%]; P?<?.001). The differences were smaller in regression models controlling for company size and year and when considering only companies reporting research and development expense (gross profit margin: difference, 30.5% [95% CI, 20.9%-40.1%]; P?<?.001; EBITDA margin: difference, 9.2% [95% CI, 5.2%-13.2%]; P?<?.001; net income margin: difference, 3.6% [95% CI, 0.011%-7.2%]; P?=?.05). Conclusions and Relevance:From 2000 to 2018, the profitability of large pharmaceutical companies was significantly greater than other large, public companies, but the difference was less pronounced when considering company size, year, or research and development expense. Data on the profitability of large pharmaceutical companies may be relevant to formulating evidence-based policies to make medicines more affordable.

Dataset Information

Association between gifts from pharmaceutical companies to French general practitioners and their drug prescribing patterns in 2016: retrospective study using the French Transparency in Healthcare and National Health Data System databases.

Publications

Association between gifts from pharmaceutical companies to French general practitioners and their drug prescribing patterns in 2016: retrospective study using the French Transparency in Healthcare and National Health Data System databases.

Similar Datasets

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