More often than not, family doctors receive little or no information about the harmful effects of medicines during clinic visits by pharmaceutical sales representatives (“sales reps”), according to an international study involving physicians in the United States, Canada and France. Despite the lack of information, those same physicians indicated that they also were likely to prescribe the promoted drugs, which is consistent with previous research about the influence of pharmaceutical promotional visits.
Results of the study, titled "Pharmaceutical Sales Representatives and Patient Safety: A Comparative Prospective Study of Information Quality in Canada, France and the United States," are published online in the Journal of General Internal Medicine.
In the most comprehensive study to date regarding the quality of pharmaceutical sales representative promotions to family physicians, researchers surveyed doctors in Sacramento, Montreal, Vancouver and Toulouse. They found that in 59 percent of the visits to doctors’ offices sales reps failed to provide information about common or serious side effects from their products or the types of patients who should not use their drugs.
“We found that interactions between doctors and drug sales reps failed to meet even a minimum standard for the information needed for safe prescribing,” said Michael Wilkes, a UC Davis professor of medicine who is an expert on drug promotion and one of the study's co-authors. “Since physicians are heavily influenced by promotional sales visits from drug company representatives, patient safety is being compromised by what we found to be a real lack of adequate information about drug risks and dangers.”
In the study, 255 physicians were asked to fill out a questionnaire following each encounter with drug sales representatives, who regularly visit doctors’ offices to promote their products and provide free samples -- as well as free food and invitations to events in some cases. The study focused on how often information was provided about a drug’s safety profile.
Overall, the physicians reported on 1,692 drug promotions, which included medications for hypertension, osteoporosis, depression and Type 2 diabetes. Serious risks were rarely mentioned, in only 6 percent of promotions, although many times the promotion was for a drug with a U.S. Food and Drug Administration “black box” or Canadian boxed warning. In the U.S., a black box label warning indicates serious or life-threatening risks. Canada also has boxed warnings in labeling; France does not. In more than half (57 percent) of the promotions involving drugs with governmental warnings, no harm was mentioned to physicians.
Compared to U.S. and Canadian doctors, those in France were more likely to be told of a harmful effect in a promotional visit. However, at all the research locations physicians were rarely informed about serious adverse events from a promoted drug. Despite this, the physicians surveyed typically judged the sales information as positive and said they were likely to start or increase prescribing a promoted drug after sales visits, even though they received little or no safety information about the drug.
“Laws in all three countries require sales representatives to provide information on harm as well as benefits,” said lead author Barbara Mintzes of the University of British Columbia and an expert on drug advertising. “But no one is monitoring these visits, and there are next to no sanctions for misleading or inaccurate promotion.”
This is the first study to compare the information provided by drug sales reps in different regulatory environments and the first to systematically focus on safety information. Wilkes and the study co-authors suggest that stricter regulatory oversight could help ensure doctors receive more accurate and complete information. Unless oversight is improved, they say, limiting sales representative interactions with physicians may be the most effective way to ensure that drug treatment decisions are based on adequate information about patient harm as well as on patient benefits.
“Some doctors choose to have a ‘no sales rep’ policy to guard against being unduly influenced,” said Wilkes. “But others find the offer of free drugs and free food too good to pass up even when they know they are being told only half the true story about a drug. Our first obligation is to our patients’ safety. That means doing our own homework about every drug we prescribe to avoid the subtle persuasion that takes place during conversations with sales people.”
In addition to Wilkes and Mintzes, the other study authors were Joel Lexchin, School of Health Policy and Management, YorkUniversity, Toronto, Ontario; Jason M. Sutherland, School of Population and Public Health, University of British Columbia; Marie-Dominique Beaulieu, Department of Family Medicine, University of Montreal; Geneviève Durrieu, Department of Medical and Clinical Pharmacology, Faculty of Medicine, University of Toulouse, France; and Ellen Reynolds, Department of Anesthesiology, Pharmacology and Therapeutics, University of British Columbia.
This study was funded by the Institute of Health Services and Policy Research, Canadian Institutes of Health Research, and the Michael Smith Health Research Foundation.