Journal of General Internal Medicine

, Volume 28, Issue 10, pp 1368–1375

Pharmaceutical Sales Representatives and Patient Safety: A Comparative Prospective Study of Information Quality in Canada, France and the United States

Authors

    • School of Population and Public HealthUniversity of British Columbia
  • Joel Lexchin
    • School of Health Policy and ManagementYork University
  • Jason M. Sutherland
    • School of Population and Public HealthUniversity of British Columbia
  • Marie-Dominique Beaulieu
    • Department of Family MedicineUniversity of Montreal
  • Michael S. Wilkes
    • Department of Internal MedicineUniversity of California at Davis
  • Geneviève Durrieu
    • Department of Medical and Clinical Pharmacology, Faculty of MedicineUniversity of Toulouse
  • Ellen Reynolds
    • Department of Anesthesiology, Pharmacology and TherapeuticsUniversity of British Columbia
Original Research

DOI: 10.1007/s11606-013-2411-7

Cite this article as:
Mintzes, B., Lexchin, J., Sutherland, J.M. et al. J GEN INTERN MED (2013) 28: 1368. doi:10.1007/s11606-013-2411-7

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.

KEY WORDS

health policy patient safety primary care health services research

Supplementary material

11606_2013_2411_MOESM1_ESM.pdf (371 kb)
ESM 1 (PDF 370 kb)
11606_2013_2411_MOESM2_ESM.docx (708 kb)
ESM 2 (DOCX 708 KB)

Copyright information

© Society of General Internal Medicine 2013