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

Barbara Mintzes, Joel Lexchin, Jason M. Sutherland, Marie Dominique Beaulieu, Michael S Wilkes, Geneviève Durrieu, Ellen Reynolds

Research output: Contribution to journalArticle

56 Citations (Scopus)

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.

Original languageEnglish (US)
Pages (from-to)1368-1375
Number of pages8
JournalJournal of General Internal Medicine
Volume28
Issue number10
DOIs
StatePublished - Oct 2013

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Patient Safety
France
Canada
Prospective Studies
Safety
Physicians
Pharmaceutical Preparations
Drug Labeling
Primary Care Physicians
United States Food and Drug Administration
Industry
Cohort Studies
Outcome Assessment (Health Care)
Health

Keywords

  • health policy
  • health services research
  • patient safety
  • primary care

ASJC Scopus subject areas

  • Internal Medicine

Cite this

Pharmaceutical sales representatives and patient safety : A comparative prospective study of information quality in Canada, France and the United States. / Mintzes, Barbara; Lexchin, Joel; Sutherland, Jason M.; Beaulieu, Marie Dominique; Wilkes, Michael S; Durrieu, Geneviève; Reynolds, Ellen.

In: Journal of General Internal Medicine, Vol. 28, No. 10, 10.2013, p. 1368-1375.

Research output: Contribution to journalArticle

Mintzes, Barbara ; Lexchin, Joel ; Sutherland, Jason M. ; Beaulieu, Marie Dominique ; Wilkes, Michael S ; Durrieu, Geneviève ; Reynolds, Ellen. / Pharmaceutical sales representatives and patient safety : A comparative prospective study of information quality in Canada, France and the United States. In: Journal of General Internal Medicine. 2013 ; Vol. 28, No. 10. pp. 1368-1375.
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N2 - 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.

AB - 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.

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