Association between gifts from pharmaceutical companies to French general practitioners and their drug prescribing patterns in 2016: retrospective ...
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RESEARCH Association between gifts from pharmaceutical companies to BMJ: first published as 10.1136/bmj.l6015 on 5 November 2019. Downloaded from http://www.bmj.com/ on 12 March 2020 by guest. Protected by copyright. French general practitioners and their drug prescribing patterns in 2016: retrospective study using the French Transparency in Healthcare and National Health Data System databases Bruno Goupil,1 Frédéric Balusson,2 Florian Naudet,3,4 Maxime Esvan,3 Benjamin Bastian,1,3 Anthony Chapron,1,3 Pierre Frouard1 1 Department of General ABSTRACT the GP groups with at least one gift in 2016 (−€5.33 Medicine, University of Rennes OBJECTIVE (99.9% confidence interval −€6.99 to −€3.66) 1, Rennes, France To evaluate the association between gifts from compared with the GP group with gifts valued at 2 EA 7449 (Pharmaco- pharmaceutical companies to French general €1000 or more reported in 2016) (P
RESEARCH version of the Sunshine Act legislation was implemented database and data from the National Health Data in 2011, including the introduction of the Transparency System. From the Transparency in Healthcare database BMJ: first published as 10.1136/bmj.l6015 on 5 November 2019. Downloaded from http://www.bmj.com/ on 12 March 2020 by guest. Protected by copyright. in Healthcare database.1 6 (www.data.gouv.fr), we calculated the total monetary The National Health Data System (Système value of the gifts listed for each French GP in 2016. We National des Données de Santé) can be used to also included GPs without any gift listed for 2016. For analyse drug prescribing by French doctors.7 This such GPs, we calculated the total monetary value of database is used for multiple purposes, including the the gifts received from 2013 to 2015, to differentiate calculation of drug prescription efficiency indicators between those who did not and those who did receive for doctors’ performance related financial incentives gifts between 2013 and 2016. (Rémunération sur Objectif de Santé Publique).8 Under an agreement with the National Health The Transparency in Healthcare and National Health Insurance (the French system that offers healthcare Data System databases (box 1) offer an opportunity coverage to all citizens), one of its data officers to investigate the influence of gift donations on the extracted from the National Health Data System the prescribing patterns of French general practitioners drug prescription efficiency indicators used for the (GPs). We evaluated the association between gifts performance related financial incentives, the amount reported in the Transparency in Healthcare database reimbursed for drug prescriptions per visit (to the practice and prescribing by French GPs in 2016. As promotional or at home) in 2016, and data on the sociodemographic activities by pharmaceutical companies are expected characteristics of the GPs and patients. Data in the to influence the quality, quantity, and cost of drug National Health Data System are anonymised. prescribing, we hypothesised that an association exists We focused on 2016 data because of the long between the donations of gifts and poorer quality and administrative procedure to obtain authorisation to more costly prescribing patterns. access the National Health Data System. Our first application was submitted on 31 August 2017, and a Methods protocol detailing the analysis plan was registered on Data sources 17 January 2018. Ethical approval for the study was This retrospective study was conducted using data provided on 24 May 2018. Data were available on a on gifts reported in the Transparency in Healthcare secured remote portal on 21 November 2018. Box 1: Databases and definitions Transparency in Healthcare • This database was created after the introduction of the French “Sunshine Act” in 2011 and is managed by the French ministry of health • Since 2013, all data declared by pharmaceutical, medical device, and other health related companies on their financial links with healthcare professionals and organisations are collected and made accessible • Companies must complete a declaration • Data are searchable through a French government public website (transparence.sante.gouv.fr) and can be downloaded (data.gouv.fr) Gifts • One of the information types reported in Transparency in Healthcare • Any type of present or payment given by a company to a healthcare professional without any counterpart, such as performing a work or a service • Gifts include donations of equipment, invitations, catering expenses, travel expenses, and cash payments such as commissions, rebates, or reimbursement of expenses • Presents and payments must be declared by companies, starting from €10.00 (£8.60; $11.00) including taxes (date, amount, type of donation, identity of the receiver, identity of the company) National Health Data System • This database was created and is managed by the French National Health Insurance system • Information is collected on all reimbursement claims from French healthcare insurances • The database includes, for example, anonymised data on patients, data on prescribers, visits to the practice or at home, dispensed and reimbursed drugs, chronic medical conditions • 99% of the French population is covered by the database • The data are used to calculate the drug prescription efficiency indicators for the French performance related financial incentives programme • Anonymous data are accessible for research purposes on a secure portal, after authorisation French performance related financial incentives programme • This programme is based on data from the National Health Data System and was launched in 2011 • The aim of the programme for doctors (Rémunération sur Objectifs de Santé Publique) is to encourage more efficient drug prescription patterns and to control health expenditure • The programme uses drug prescription indicators to assess GPs’ prescription patterns • Over-the-counter drugs are not included in the drug prescription indicators 2 doi: 10.1136/bmj.l6015 | BMJ 2019;367:l6015 | the bmj
RESEARCH Study population or of limiting the cost of prescriptions, particularly by We included GPs who had worked in metropolitan promoting generic drugs.8 We considered these 11 BMJ: first published as 10.1136/bmj.l6015 on 5 November 2019. Downloaded from http://www.bmj.com/ on 12 March 2020 by guest. Protected by copyright. France or overseas territories from 1 January 2016 to efficiency indicators (11 variables) and the amount 31 December 2016. To obtain a homogeneous study reimbursed by the National Health Insurance for the drugs population, we excluded those who were not family prescribed and dispensed per visit in 2016 (one variable) doctors (eg, allergists, angiologists, geriatricians, as outcomes of interest. Table 1 and supplementary emergency doctors, and others listed by the National appendix 1 provide details on the indicators. Health Insurance), did not work exclusively in the private sector (unlike standard practice in France; that Covariates is, GPs employed by a public healthcare institution or We adjusted for several covariates in the National Health who worked in both the private sector and a public Data System that could influence drug prescriptions. The healthcare institution), worked for part of 2016, and covariates related to the GPs’ characteristics were sex, had fewer than five registered patients. These exclusion age, size of the city where the practice is located (
RESEARCH Table 1 | Outcomes of interest. Data are for patients registered with each general practitioner (GP) in 2016 Outcomes of interest Calculations What high values indicate BMJ: first published as 10.1136/bmj.l6015 on 5 November 2019. Downloaded from http://www.bmj.com/ on 12 March 2020 by guest. Protected by copyright. Cost of all drugs prescribed by GP, dispensed and reimbursed to patient by the National Amount reimbursed for drug prescriptions/visit (€) More health expenditures Health Insurance, divided by number of visits by the GP (€) 11 indicators used for the performance related financial incentives programme Number of antibiotic prescriptions to 16-65 year old patients without chronic disease Antibiotics to 16-65 year olds (%) compared with total number of 16-65 year old patients without chronic disease (%) Number of patients with a new prescription of benzodiazepines for more than 12 weeks Benzodiazepines >12 weeks (%) compared with total number of patients (%) More side effects or more misuse Number of patients older than 65 years with one or more prescriptions of long half-life Benzodiazepines to >65 year olds (%) benzodiazepines compared with total number of patients older than 65 years (%) Number of patients older than 65 years with one or more prescriptions of vasodilators Vasodilators to >65 year olds (%) compared with total number of patients older than 65 years (%) Angiotensin converting enzyme (ACE) inhibitors/ Number of ACE inhibitors items prescribed compared with total number of ACE inhibi- ACE inhibitors+sartans (%) tors and sartans items prescribed (%) Number of patients with prescriptions for low dose aspirin compared with total number Antiplatelets (%) of patients treated with antiplatelet drugs (%) Number of antibiotic items prescribed as generic drugs compared with total number of Generic antibiotics (%) antibiotic items prescribed (%) Number of antidepressant items prescribed as generic drugs compared with total num- Generic antidepressants (%) Fewer health expenditures ber of antidepressant items prescribed (%) Number of antihypertensive items prescribed as generic drugs compared with total Generic antihypertensives (%) number of antihypertensive items prescribed (%) Number of PPI items prescribed as generic drugs compared with total number of PPI Generic proton pump inhibitors (PPIs) (%) items prescribed (%) Number of statin items prescribed as generic drugs compared with total number of Generic statins (%) statin items prescribed (%) gifts, we performed multivariate analyses by replacing included for analysis. The name and practice postal the different groups by the median monetary value of code for 3338 listed GPs (6.2% of the sample) could gifts for each group (the no gift group and the pre-2016 not be matched to data in the National Health Data gift group (ie, no reported gifts in 2016, but at least one System. These doctors belonged more often to the no gift between 2013 and 2015) were grouped together as gift group (16.4%) than to the other groups (range 2.5- having received no gift in 2016). To test the effect of 5.3%). A further 9168 GPs were excluded according to extreme values on the results we performed the post the exclusion criteria (fig 1). Supplementary appendix hoc sensitivity analyses after excluding the first and 2 summarises the steps leading to the selection of the last centiles of each explanatory variable and covariate. GP groups. Statistical analyses were performed using SAS software 9.4 (SAS Institute, Cary NC). As we were not Description of study population allowed to export the National Health Data System The mean age of included GPs was 53.5 (SD 10.2) data, we analysed the information in the National years, 26 614 (64.5%) were men and 12 857 (31.2%) Health Data System remote portal. practised in rural areas. In 2016, the GPs carried out a mean 5359 (SD 2510) visits and had 1177 Changes to the protocol (SD 577) registered patients. Among the 41 257 GPs We updated the Transparency in Healthcare data included in the study, 27 512 (66.7%) were listed in on 5 April 2018. This slightly changed the size of the Transparency in Healthcare database as having the different GP groups. As GPs with fewer than five received gifts in 2016, and 36 232 (87.8%) as having patients were not eligible for performance related received gifts since the launch of the database in 2013. incentives, we excluded them from the analysis. In Comparison of the GPs and patients’ characteristics multivariate analyses we had to split patients in to two (variables used for adjustment) using the analysis age groups (
RESEARCH 53 763 GPs paired in National Council of the College of Physicians list and Transparency in Healthcare database BMJ: first published as 10.1136/bmj.l6015 on 5 November 2019. Downloaded from http://www.bmj.com/ on 12 March 2020 by guest. Protected by copyright. 3338 Failed to match name and postal code with National Health Data System 50 425 GPs paired with National Health Data System 9168 Excluded from analysis 2414 Non-exclusive private sector 220 Particular mode of exercise 1377 Worked part of 2016 3367
RESEARCH Table 2 | Primary analyses. Values are means (standard deviations) Study groups P values BMJ: first published as 10.1136/bmj.l6015 on 5 November 2019. Downloaded from http://www.bmj.com/ on 12 March 2020 by guest. Protected by copyright. Outcomes All No gift Pre-2016 gift €10-€69 €70-€239 €240-€999 ≥€1000 Univariate Multivariate Amount reimbursed for drug prescriptions/ 45.8 (40.1) 47.8 (24.4) 48.2 (21.8) 49.4 (21.5) 51.5 (22.0) 53.2 (21.0) 49.1 (25.3)
RESEARCH by pharmaceutical companies.10 Finally, compared solution to health problems.2 In other words, receiving with the no gift group no difference was found in the gifts from a company might not only be the direct cause BMJ: first published as 10.1136/bmj.l6015 on 5 November 2019. Downloaded from http://www.bmj.com/ on 12 March 2020 by guest. Protected by copyright. percentage of antibiotic prescribed for patients aged of a prescription pattern, but also be a symptom of a 16 to 65 years and of long half-life benzodiazepines for general behaviour. patients older than 65 years. Our literature search did not find a unique or validated indicator to evaluate the GPs’ drug prescription quality Strengths and limitations of this study in a general way.16 Therefore, we used multiple This study has several strengths. We tried to reduce indicators validated by the French National Health confounding bias by taking into account the main Insurance to assess prescribing patterns.8 Some of available confounders in the multivariate analysis.9 them are also used in drug utilisation studies.17 Their The use of databases is an effective way to explain and validity is, however, questionable.18 highlight differences in prescribing patterns that are Performance related financial incentive indicators minimised in declarative studies where doctors are were not available for 0.64% to 3.04% of GPs, which directly interviewed on the influence of promotional roughly corresponds to the 2.8% of refusals from activities by pharmaceutical companies.2 The external doctors to collaborate in this process.19 Such missing validity of our results is shown by concordance data may be associated with the gifts perceived and between the mean values for the indicators in our also with the GP’s pattern of drug prescribing. population and those of the national averages.11 French GPs may benefit from industry (eg, gifts) Our study has some limitations. We do not know and from the National Health Insurance through the whether all gifts were mentioned or the extent of performance related financial incentive programme. misinformation in the Transparency in Healthcare Gifts from industry and the performance related database because data are only based on the financial incentives programme cannot be directly statements made by the pharmaceutical companies linked to each other because no indicator assessed without effective control.5 The 6.2% of failed matches GPs’ financial links with industry. A GP might receive for GPs might have introduced some bias, especially the maximum remuneration from the performance because the matching failure rate was different among related financial incentive programme and the GP groups. concomitantly many gifts from industry. Nevertheless, Confounding is a major problem in observational if we assume that the desire of profit is a confounder, research. Methods, such as computation of E-values our results are not suggesting optimisation trade-offs (minimum strength of association that an unmeasured by GPs. Indeed, in our study GPs with the best drug confounder would need to have with both treatment prescription indicator results and therefore the highest and outcome to fully explain away a specific treatment- National Health Insurance financial incentive for these outcome association, conditional on the measured indicators seemed to receive fewer gifts from industry. covariates), have been proposed but have caveats.12 Finally, it is not possible to conclude that the Despite the adjustment of the analysis to various different drug prescription patterns are the result of the available factors that might influence prescribing promotional activities by pharmaceutical companies. patterns, we could not take all of them into account. For An alternative explanation could be that GPs who example, we did not include type of GP activity (in a group receive gifts may be more targeted or receptive to or alone), status of university internship supervisor, or pharmaceutical marketing because they have specific other methods of pharmaceutical promotion. The study prescribing patterns.2 All these possible caveats is therefore prone to residual confounding. suggest that these findings should be interpreted with In addition, in the absence of clinical data we caution, and they preclude any definitive conclusion in could not fully understand the reasoning leading to terms of causality. each drug prescription.13 Other studies have shown a link between payments from industry and specific Results consistent with the literature prescriptions (eg, opioids, gabapentinoids).14 15 As These results are consistent with recent meta-analyses the Transparency in Healthcare database does not and systematic reviews showing an association specify the marketed drug or drugs associated with between gifts from pharmaceutical companies and each listed gift, we could not link a gift to a specific more frequent, lower quality and more costly drug prescription.5 Our study explores prescription patterns prescriptions.14 20-24 Two recent studies also found a in a more global way. Indeed, providing gifts is not the lower prescription rate of generic drugs by doctors only way industry uses to promote drugs. For instance, who benefit from pharmaceutical companies.25 26 sponsored medical press, advertising directed towards According to Health Action International, no study has doctors, sponsored continuing medical education shown health benefits from promotional activities of courses (possibly with key opinion leaders), one- pharmaceutical companies.1 2 to-one visits from sales representatives, and sample Our post hoc analyses suggest a possible dose-effect delivery are many other methods to influence doctors’ association between gifts paid by pharmaceutical prescribing patterns. Receiving a gift from a company companies and the cost of drug prescriptions per visit might reflect a higher acceptance, an interest in and drug prescription efficiency indicators. A similar novelty, a belief in the promotion, a favourable image observation was reported by two large retrospective of the firms, and a belief in using drugs as a first studies in the United States in 2016.24 27 the bmj | BMJ 2019;367:l6015 | doi: 10.1136/bmj.l6015 7
RESEARCH Our study shows a significant difference between evaluate these features also in specialist doctors and the group that did not receive gifts and the pre-2016 particularly among the so-called key opinion leaders.2 BMJ: first published as 10.1136/bmj.l6015 on 5 November 2019. Downloaded from http://www.bmj.com/ on 12 March 2020 by guest. Protected by copyright. gift group for generic drug prescription of antibiotics, Perhaps the time has come for interventional studies antihypertensive agents, and statins, suggesting that to test the impact of restrictive policies on physicians’ the observed association could also be observed over drug prescription patterns prospectively. time. We thank Medhi Gabbas for extracting data from the National Health Insurance database, Elisabetta Andermarcher for English language Health and economic impacts editing, and Emmanuel Allory, Irène Frachon, Barbara Mintzes, The more frequent use of some drugs, such as Emmanuel Oger, Dominique Somme, and Bruno Toussaint for their help. benzodiazepines and vasodilators, increases the risk Contributors: BG and PF initiated and designed the study, searched of well known adverse effects of these drug classes, the literature, interpreted the results, and wrote the manuscript. FB with occasional serious or fatal consequences. Our performed the analysis and interpreted results. FN and ME contributed data suggest that prescription of these drug classes to the study design and interpreted the results. BB contributed to the study design. AC contributed to the study design and offered increases slowly but progressively from the no gift institutional support. PF is guarantor. All authors have critically revised group to the €1000 or more group. Prescriptions of the manuscript for important intellectual content and approved the brand name drugs instead of generic drugs represent manuscript. The corresponding author attests that all listed authors meet the authorship criteria and that no others meeting the criteria an additional cost for the National Health Insurance have been omitted. with no proved benefit for the patient. In France, the Funding: None. price of a generic drug is at least 60% lower than the Competing interest: All authors have completed the ICMJE uniform price of the original drug.28 With an additional €1.2 to disclosure form at www.icmje.org/coi_disclosure.pdf and declare: €5.3 reimbursed per drug prescription, GPs with gifts no financial relationships with any organisations that might have an reported in the Transparency in Healthcare database interest in the submitted work in the previous three years; AC reports personal fees and non-financial support from Roche, personal fees are associated with an important additional charge for and non-financial support from Novartis Pharma, and personal fees the National Health Insurance compared with GPs who from Congrès colloques conventions, outside the submitted work; no did not have any gift reported. Notably, among the 12 other relationships or activities that could appear to have influenced the submitted work. outcomes we used, the most significant were directly linked with economic factors: cost of drug prescription Ethical approval: This study was approved by the French Commission Nationale Informatique et Libertés (authorisation CNIL DR 2018-089). per visit, and generic drug prescription. This is in line A letter has been delivered to all French URPS (Unions Régionales with studies showing that pharmaceutical promotion des Professionnels de Santé) to inform general practitioners of the targets especially market issues.1 2 objective of the research and give them the right to oppose. In our study, associations were also significant Data sharing: Data from Transparency in Healthcare database are available on www.data.gouv.fr. We cannot share National Health for the “€10-€69” group. Differences in prescribing Data System data as they are only available on a secure portal. behaviours after donation of small gifts have been Authorisation to access this portal needs registration and clearance. reported by several studies and are based on donation The guarantor (PF) affirms that the manuscript is an honest, accurate, and counter-donation mechanisms that have been and transparent account of the study being reported; that no well described by humanities and social science important aspect of the study was omitted; and that any discrepancies from the study as originally planned have been explained. studies.29-31 Gifts lead to a sense of accountability and This is an Open Access article distributed in accordance with the ultimately negatively influence prescribing habits.32 Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, More generally, for most doctors the amount of gifts which permits others to distribute, remix, adapt, build upon this work reported represents a small part of their annual non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non- income, and for pharmaceutical industries a small commercial. See: http://creativecommons.org/licenses/by-nc/4.0/. financial engagement compared with their benefits in terms of selling drugs.2 1 Health Action International. Fact or Fiction: What Healthcare Professionals Need to Know about Pharmaceutical Marketing in the European Union – Health Action International. 2016. https://haiweb. Results in favour of the influence of gifts on drug org/publication/fact-or-fiction-pharmaceutical-marketing-in-the- prescriptions european-union/ 2 World Health Organization, Health Action International. Before the creation of the Transparency in Healthcare Understanding and responding to pharmaceutical promotion: database, the scope and frequency of gifts paid by a practical guide. 2009. http://haiweb.org/wp-content/ pharmaceutical companies to French GPs were not uploads/2015/05/Pharma-Promotion-Guide-English.pdf 3 Fabbri A. Santos Ancel la, Mezinska S, Mulinari S, Mintzes B. Sunshine easily accessible. 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Future research should assess the association renforcement de la sécurité sanitaire du médicament et des produits between prescribing patterns and conventions, de santé. 2011-2012 Dec 29, 2011. another link of interests reported in the Transparency 7 Bezin J, Duong M, Lassalle R, et al. The national healthcare system claims databases in France, SNIIRAM and EGB: Powerful tools for in Healthcare database involving obligations on pharmacoepidemiology. Pharmacoepidemiol Drug Saf 2017;26:954- both sides (such as speaker at a conference), and 62. doi:10.1002/pds.4233 8 doi: 10.1136/bmj.l6015 | BMJ 2019;367:l6015 | the bmj
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