Sales Representatives Provide Inadequate Safety Information
Physicians ready to prescribe with lack of data on harmful effects of promoted medicines
THURSDAY, April 11 (HealthDay News) -- Pharmaceutical sales representatives (PSRs) rarely inform primary care physicians about drug safety information during sales visits, according to research published online April 10 in the Journal of General Internal Medicine.
Barbara Mintzes, Ph.D., of the University of British Columbia in Vancouver, British Columbia, Canada, and colleagues conducted a prospective cohort study in Canada, France, and the U.S. to determine if PSRs adequately communicated safety information to primary care physicians during consecutive sales visits.
According to the researchers, 255 physicians had 1,692 drug-specific sales visits from May 2009 to June 2010. During these visits, "minimally adequate safety information" was only provided by PSRs in 1.7 percent of the visits, and they did not differ among the sites (range 0.9 percent to 3.0 percent). Serious adverse events were mentioned only in 5 to 6 percent of visits per site, despite a high proportion of the drugs promoted as having either a U.S. Food and Drug Administration "Black Box" warning or a Canadian boxed warning. The physicians considered the quality of scientific information presented to be good or excellent in 54 percent of the sales visits, and they were "somewhat" or "very likely" to prescribe two-thirds of the time after the visits.
"Our results suggest a serious lack of information on harmful effects of promoted medicines," the authors write. "Unless regulatory oversight is improved to ensure balanced information, limits to PSR-physician interactions may be the most effective way to ensure that prescribing decisions are based on adequate information on harm as well as benefit."