Date: 05 Apr 2013
Pharmaceutical Sales Representatives and Patient Safety: A Comparative Prospective Study of Information Quality in Canada, France and the United States
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.
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).
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.
“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.
Norris P, Herxheimer A, Lexchin J, Mansfield P. Drug Promotion: What We Know What We Have Yet to Learn. World Health Organisation and Health Action International. Geneva: 2005. Available at: http://apps.who.int/medicinedocs/pdf/s8109e/s8109e.pdf. Accessed January 24, 2013.
Chalkley P. Targeting accessible physicians. Canadian Pharmaceutical Marketing. April 2009:29–30.
Lexchin J. What information do physicians receive from sales representatives? Can Fam Physician. 1997;43:941–945.PubMed
Anon. 15 ans d’observervation et un constat: rien à attendre de la visite médicale pour mieux soigner. La Revue Prescrire. 2006;26(272):383–389.
Government of Canada. Federal Food and Drugs Act and Regulations. Available at: http://www.hc-sc.gc.ca/fn-an/legislation/acts-lois/index-eng.php. Accessed January 24, 2013.
Salant P, Dillman DA. How to conduct your own survey. New York: Wiley; 1994.
Strang DG, Gagnon M, Molloy DW, Darzins P, Etchells E, Bédard M, Davidson W. Development of a standardized, comprehensive ‘ideal drug detail’. Can J Clin Pharmacol. 2001;8(2):73–77.PubMed
Cegedim Strategic Data - CSD – Global Promotion Database, 2009–2010. www.cegedim.com.
Health Canada. Regulation of Health Product Advertising in Canada – Overview for Physicians. Ottawa: July 11, 2011. Available at: http://www.hc-sc.gc.ca/dhp-mps/advert-publicit/pol/overview-apercu-eng.php. Accessed January 24, 2013.
US Food and Drug Administration (FDA). Truthful Prescription Drug Advertising and Promotion (Bad Ad Program). Updated July 18, 2012. Available at: http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/DrugMarketingAdvertisingandCommunications/ucm209384.htm#RecognizeReport. Accessed January 24, 2013.
Haute Autorité de la Santé (H.A.S.) Questions Réponses Rélatives à la Certification de la Visite Médicale. October 2009. Available at : http://www.has-sante.fr/portail/jcms/c_334342/referentiel-de-certification-de-la-visite-medicale. Accessed January 24, 2013.
- Pharmaceutical Sales Representatives and Patient Safety: A Comparative Prospective Study of Information Quality in Canada, France and the United States
Journal of General Internal Medicine
Volume 28, Issue 10 , pp 1368-1375
- Cover Date
- Print ISSN
- Online ISSN
- Springer US
- Additional Links
- health policy
- patient safety
- primary care
- health services research
- Industry Sectors
- Author Affiliations
- 1. School of Population and Public Health, University of British Columbia, #307, 2176 Health Sciences Mall, Vancouver, British Columbia, V6T 1Z3, Canada
- 2. School of Health Policy and Management, York University, Toronto, Ontario, Canada
- 3. Department of Family Medicine, University of Montreal, Montreal, Quebec, Canada
- 4. Department of Internal Medicine, University of California at Davis, Davis, California, USA
- 5. Department of Medical and Clinical Pharmacology, Faculty of Medicine, University of Toulouse, Toulouse, France
- 6. Department of Anesthesiology, Pharmacology and Therapeutics, University of British Columbia, Vancouver, British Columbia, Canada