title: Pharmaceutical sales representatives and patient safety: a comparative prospective study of information quality in Canada, France and the United States.
abstract: BACKGROUND
  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.
  
  
  CONCLUSIONS
  "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.
authors.affiliation: School of Population and Public Health, University of British Columbia, #307, 2176 Health Sciences Mall, Vancouver, British Columbia, V6T 1Z3, Canada, Barbara.mintzes@ti.ubc.ca.
authors.forename: Barbara
authors.initials: B
authors.lastname: Mintzes
authors.forename: Joel
authors.initials: J
authors.lastname: Lexchin
authors.forename: Jason M
authors.initials: JM
authors.lastname: Sutherland
authors.forename: Marie-Dominique
authors.initials: MD
authors.lastname: Beaulieu
authors.forename: Michael S
authors.initials: MS
authors.lastname: Wilkes
authors.forename: Geneviève
authors.initials: G
authors.lastname: Durrieu
authors.forename: Ellen
authors.initials: E
authors.lastname: Reynolds
mesh_terms: D001291:Attitude of Health Personnel; D002170:Canada; D004345:Drug Industry / Q000592:standards*; D004346:Drug Information Services / Q000592:standards*; D011307:Drug Prescriptions / Q000592:standards; D064420:Drug-Related Side Effects and Adverse Reactions / Q000209:etiology; D005602:France; D006302:Health Services Research / Q000379:methods; D006801:Humans; D040541:Marketing / Q000592:standards*; D061214:Patient Safety; D010818:Practice Patterns, Physicians' / Q000592:standards; D011320:Primary Health Care / Q000592:standards; D011446:Prospective Studies; D014481:United States
references.citation: PLoS Med. 2008 Jan 3;5(1):e1
references.pmid: 18177202
references.citation: PLoS Med. 2007 Apr;4(4):e150
references.pmid: 17455991
references.citation: JAMA. 1995 Apr 26;273(16):1296-8
references.pmid: 7715044
references.citation: Psychiatr Serv. 2007 Oct;58(10):1292-6
references.pmid: 17914005
references.citation: BMC Public Health. 2010 Nov 30;10:743
references.pmid: 21118551
references.citation: Can J Clin Pharmacol. 2001 Summer;8(2):73-7
references.pmid: 11493934
references.citation: Acad Med. 2009 Aug;84(8):994-1002
references.pmid: 19638762
references.citation: JAMA. 2000 Jan 19;283(3):373-80
references.pmid: 10647801
references.citation: PLoS Med. 2010 Oct 19;7(10):e1000352
references.pmid: 20976098
references.citation: Can Fam Physician. 1997 May;43:941-5
references.pmid: 9154366
references.citation: N Engl J Med. 2005 Jun 23;352(25):2576-8
references.pmid: 15972862