Dataset Information

Pharmaceutical sales representatives and patient safety: a comparative prospective study of information quality in Canada, France and the United States.

ABSTRACT:

Introduction

The information provided by pharmaceutical sales representatives has been shown to influence prescribing. To enable safe prescribing, medicines information must include harm as well as benefits. Regulation supports this aim, but relative effectiveness of different approaches is not known. The United States (US) and France directly regulate drug promotion; Canada relies on industry self-regulation. France has the strictest information standards.

Methods

This is a prospective cohort study in Montreal, Vancouver, Sacramento and Toulouse. We recruited random samples of primary care physicians from May 2009 to June 2010 to report on consecutive sales visits. The primary outcome measure was "minimally adequate safety information" (mention of at least one indication, serious adverse event, common adverse event, and contraindication, and no unqualified safety claims or unapproved indications).

Results

Two hundred and fifty-five physicians reported on 1,692 drug-specific promotions. "Minimally adequate safety information" did not differ: 1.7 % of promotions; range 0.9-3.0 % per site. Sales representatives provided some vs. no information on harm more often in Toulouse than in Montreal and Vancouver: 61 % vs. 34 %, OR?=?4.0; 95 % CI 2.8-5.6, or Sacramento (39 %), OR?=?2.4; 95 % CI 1.7-3.6. Serious adverse events were rarely mentioned (5-6 % of promotions in all four sites), although 45 % of promotions were for drugs with US Food and Drug Administration (FDA) "black box" warnings of serious risks. Nevertheless, physicians judged the quality of scientific information to be good or excellent in 901 (54 %) of promotions, and indicated readiness to prescribe 64 % of the time.

Discussion

"Minimally adequate safety information" did not differ in the US and Canadian sites, despite regulatory differences. In Toulouse, consistent with stricter standards, more harm information was provided. However, in all sites, physicians were rarely informed about serious adverse events, raising questions about whether current approaches to regulation of sales representatives adequately protect patient health.

SUBMITTER: Mintzes B

PROVIDER: S-EPMC3785667 | biostudies-literature | 2013 Oct

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Pharmaceutical sales representatives and patient safety: a comparative prospective study of information quality in Canada, France and the United States.

Mintzes Barbara B Lexchin Joel J Sutherland Jason M JM Beaulieu Marie-Dominique MD Wilkes Michael S MS Durrieu Geneviève G Reynolds Ellen E

Journal of general internal medicine 20130405 10

<h4>Introduction</h4>The information provided by pharmaceutical sales representatives has been shown to influence prescribing. To enable safe prescribing, medicines information must include harm as well as benefits. Regulation supports this aim, but relative effectiveness of different approaches is not known. The United States (US) and France directly regulate drug promotion; Canada relies on industry self-regulation. France has the strictest information standards.<h4>Methods</h4>This is a prosp ...[more]

PMID: 23558775

Similar Datasets

Project description:IntroductionAccepting gifts from pharmaceutical sales representatives (sales reps) or meeting them is correlated with excessive, more expensive and sometimes less rational prescribing. French general practitioners (GPs) tend to hold an unfavorable opinion of the pharmaceutical industry, yet the behavior they adopt with sales reps is generally favorable. Until now, no study has sought to explain the reasons for this discrepancy. This study explores GP experiences to better understand their ambivalent behavior.MethodThis qualitative descriptive study was based on semi-structured face-to-face interviews with French GPs in the south-east of France. An interpretative phenomenological approach was chosen to explore individual professional practices and to model the phenomenon through in-depth analysis of semi-structured interviews. A general inductive analysis was carried out. Data were analyzed by researchers from different disciplines (psychology, sociology and general practice).ResultsTen GPs were interviewed for an average of 50 minutes. The analysis revealed three forces that combine to motivate GPs to keep meeting sales reps despite their unfavorable opinion of these visits: practical reasons such as the need for a substitute for continuing education; social and cultural reasons such as courtesy towards representatives; and psychological mechanisms such as cognitive dissonance and a hidden curriculum.DiscussionThe GP-representative relationship is complex and involves psychological mechanisms that the medical profession often fails to recognize. GPs use reps as a convenient tool for continuing education, particularly in the setting of a private practice where GPs feel pressed for time. Cognitive dissonance is a well-supported theory in social psychology that explains how a person maintains a behavior while having an unfavorable opinion of it. Since GP meetings with sales reps start during their internship, they could also be considered as part of a hidden curriculum. The strength of this work is to combine medical, social psychological and sociological perspectives with the original interpretative phenomenological approach. When the veil is lifted on individual ambivalence, the questions raised are more social and political than individual.

Project description:BackgroundThe food industry is responding to a rising demand for plant-based foods by developing and marketing an ever-wider range of vegan and vegetarian products under the banner of "plant-based." Understanding the nutritional properties of these products is critical.ObjectivesTo assess the number, meal type, and nutritional content of products marketed as plant-based (MaPB) from the perspective of the consumer across multiple sectors in the United States, United Kingdom, and Canada.MethodsAn online search for products MaPB was performed across supermarkets, restaurants, food manufacturers, and plant-based meal delivery companies in the United Kingdom, the United States, and Canada using the terms: "vegan," "vegetarian," and "plant-based." Online nutrition data were extracted, and whole meals that comprised >50% of ingredients such as fruits, vegetables, legumes, nuts, and seeds were identified. The nutritional content of dishes MaPB in restaurants was also directly compared with meat-containing dishes.ResultsFurther, 3488 unique products were identified, of which 962 were whole meals and 1137 were a replacement for the main protein component in a meal, including 771 meat alternatives. Across all sectors, 45% of whole meals had >15-g protein, 70% had <10% kcal from saturated fat; 29% had >10-g fiber per meal, and 86% had <1000 mg sodium. At restaurants, 1507 meat-containing dishes were identified and compared with 191 vegetarian and 81 vegan dishes. The meat-containing dishes were higher in protein [35.4 g (24.0-51.4)] compared with vegetarian [19.0 g (13.0-26.1)] and vegan [16.2 g (10.5-23.2) dishes (P < 0.001)]. The vegan dishes were low in saturated fat and sodium (SFA: 6.3 g ± 6.4, Sodium: 800 mg (545.0-1410.0) compared with both meat [SFA: 11.6 g ± 10.0; Sodium: 1280 mg (820.0-1952.0)] and vegetarian [SFA: 9.4 g ± 7.6; Sodium: 1011 mg (603.0-1560.0)] options (P < 0.001 for all comparisons).ConclusionsProducts MaPB tend to have lower concentrations of saturated fat and sodium than their meat-containing counterparts, but improvements are needed to optimize their nutritional composition.

Project description:Since electronic cigarettes (e-cigarettes) entered the U.S. marketplace in 2007, the landscape has evolved to include different product types (e.g., prefilled cartridge-based and disposable products) and flavored e-liquids (e.g., fruit, candy, mint, menthol, and tobacco flavors), which have contributed to increases in youth use (1,2). E-cigarettes have been the most commonly used tobacco product among U.S. youths since 2014; in 2019, 27.5% of high school students reported current e-cigarette use (3). To assess trends in unit sales of e-cigarettes in the United States by product and flavor type, CDC, CDC Foundation, and Truth Initiative analyzed retail scanner data during September 14, 2014-May 17, 2020, from Information Resources, Inc. (IRI). During this period, total e-cigarette sales increased by 122.2%, from 7.7 million to 17.1 million units per 4-week interval. By product type, the proportion of total sales that was prefilled cartridge products increased during September 2014-August 2019 (47.5% to 89.4%). During August 2019-May 2020, the proportion of total sales that was disposable products increased from 10.3% to 19.8%, while the proportion that was prefilled cartridge products decreased (89.4% to 80.2%). Among prefilled cartridge sales, the proportion of mint sales increased during September 2014-August 2019 (<0.1% to 47.6%); during August 2019-May 2020, mint sales decreased (47.6% to 0.3%), as menthol sales increased (10.7% to 61.8%). Among disposable e-cigarette sales during September 2014-May 2020, the proportion of mint sales increased (<0.1% to 10.5%), although tobacco-flavored (52.2% to 17.2%) and menthol-flavored (30.3% to 10.2%) sales decreased; during the same period, sales of all other flavors combined increased (17.2% to 62.1%). E-cigarette sales increased during 2014-2020, but fluctuations occurred overall and by product and flavor type, which could be attributed to consumer preferences and accessibility. Continued monitoring of e-cigarette sales and use is critical to inform strategies at the national, state, and community levels to minimize the risks of e-cigarettes on individual- and population-level health. As part of a comprehensive approach to prevent and reduce youth e-cigarettes use, such strategies could include those that address youth-appealing product innovations and flavors.

Dataset Information

Pharmaceutical sales representatives and patient safety: a comparative prospective study of information quality in Canada, France and the United States.

Introduction

Methods

Results

Discussion

Publications

Pharmaceutical sales representatives and patient safety: a comparative prospective study of information quality in Canada, France and the United States.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets