Program in Pharmaceutical Policy, Centre for Health Services and Policy Research, University of British Columbia, 429-2194 Health Sciences Mall, Vancouver, BC, Canada V6T 1Z3. morgan@chspr.ubc.ca
Prescription drugs are the fastest growing healthcare cost in Canada. Increased spending is mainly due to use of newer, more expensive medicines and a higher overall volume of prescription drug use. In the large majority of cases, empirical studies fail to support claims of a net benefit to health. Newer high-priced drugs are neither consistently safer nor more effective than older alternatives. Over 2000 new drugs and indications introduced in France from 1981-2000 were compared to existing treatments: 81% offered little to no added value and 3% were less safe or effective. In Canada, only 5% of drugs introduced from 1996-2000 offered substantial improvement to therapy. Claims linking use of newer drugs to reduced hospitalization and mortality fail to distinguish between underlying differences in disease severity and treatment outcomes. For "newer" to truly mean "better", fundamental changes are needed to the regulations governing market approval and post-approval surveillance. Such changes are possible, but would require strong political will.
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Comment On: Can J Clin Pharmacol. 2005 Winter;12(1):e10-2116055940
Patients routinely cite the media, after physicians and pharmacists, as a key source of information on new drugs, but there has been little research on the quality of drug information presented. We assessed newspaper descriptions of drug benefits and harms, the nature of the effects described and the presence or absence of other important information that can add context and balance to a report about a new drug.
We looked at newspaper coverage in the year 2000 of 5 prescription drugs launched in Canada between 1996 and 2001 that received a high degree of media attention: atorvastatin, celecoxib, donepezil, oseltamivir and raloxifene. We searched 24 of Canada's largest daily newspapers for articles reporting at least one benefit or harm of any of these 5 drugs. We recorded the benefits and harms reported and analyzed how such information was presented; we also determined whether clinical or surrogate outcomes were mentioned; if and how drug effects were quantified; whether contraindications, other treatment options and costs were mentioned; and whether any information on affiliations of quoted interviewees and potential conflicts of interest was presented.
Our search yielded 193 articles reporting at least one benefit or harm for 1 of the 5 drugs. All of the articles mentioned at least one benefit, but 68% (132/193) made no mention of possible side effects or harms. Only 24% (120/510) of mentions of drug benefits and harms presented quantitative information. In 26% (31/120) of cases in which drug benefits and harms were quantified, the magnitude was presented only in relative terms, which can be misleading. Overall, 62% (119/193) of the articles gave no quantification of the benefits or harms. Thirty-seven (19%) of the 193 articles reported only surrogate benefits. Other information needed for informed drug-related decisions was often lacking: only 7 (4%) of the articles mentioned contraindications, 61 (32%) mentioned drug costs, 89 (46%) mentioned drug alternatives, and 30 (16%) mentioned nondrug treatment options (such as exercise or diet). Sixty-two percent (120/193) of the articles quoted at least one interviewee. After exclusion of industry and government spokespeople, for only 3% (5/164) of interviewees was there any mention of potential financial conflicts of interest. Twenty-six percent (15/57) of the articles discussing a study included information on study funding.
Our results raise concerns about the completeness and quality of media reporting about new medications.
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Centre for Health Services and Policy Research, and the Department of Pharmacology and Therapeutics, University of British Columbia, Vancouver, BC. bmintzes@chspr.ubc.ca
Direct-to-consumer advertising (DTCA) of prescription drugs has increased rapidly in the United States during the last decade, yet little is known about its effects on prescribing decisions in primary care. We compared prescribing decisions in a US setting with legal DTCA and a Canadian setting where DTCA of prescription drugs is illegal, but some cross-border exposure occurs.
We recruited primary care physicians working in Sacramento, California, and Vancouver, British Columbia, and their group practice partners to participate in the study. On pre- selected days, patients aged 18 years or more completed a questionnaire before seeing their physician. We asked these patients' physicians to complete a brief questionnaire immediately following the selected patient visit. By pairing individual patient and physician responses, we determined how many patients had been exposed to some form of DTCA, the frequency of patients' requests for prescriptions for advertised medicines and the frequency of prescriptions that were stimulated by the patients' requests. We measured physicians' confidence in treatment choice for each new prescription by asking them whether they would prescribe this drug to a patient with the same condition.
Seventy-eight physicians (Sacramento n = 38, Vancouver n = 40) and 1431 adult patients (Sacramento n = 683, Vancouver n = 748), or 61% of patients who consulted participating physicians on pre-set days, participated in the survey. Exposure to DTCA was higher in Sacramento, although 87.4% of Vancouver patients had seen prescription drug advertisements. Of the Sacramento patients, 7.2% requested advertised drugs as opposed to 3.3% in Vancouver (odds ratio [OR] 2.2, 95% confidence interval [CI] 1.2-4.1). Patients with higher self- reported exposure to advertising, conditions that were potentially treatable by advertised drugs, and/or greater reliance on advertising requested more advertised medicines. Physicians fulfilled most requests for DTCA drugs (for 72% of patients in Vancouver and 78% in Sacramento); this difference was not statistically significant. Patients who requested DTCA drugs were much more likely to receive 1 or more new prescriptions (for requested drugs or alternatives) than those who did not request DTCA drugs (OR 16.9, 95% CI 7.5-38.2). Physicians judged 50.0% of new prescriptions for requested DTCA drugs to be only "possible" or "unlikely" choices for other similar patients, as compared with 12.4% of new prescriptions not requested by patients (p
Canada is strongly influenced by US cross-border direct-to-consumer advertising (DTCA) and has held consultations to discuss introduction of DTCA since 1996. This article describes a survey of Canadian drug policy experts carried out in 2001, during one such legislative review. The survey results are compared to more recent DTCA policy developments.
We recruited key informants on pharmaceutical policy to complete a faxed questionnaire that queried their opinions on DTCA information quality, effects on drug and health care use, and regulatory issues. Respondents were asked about the evidence they had used to back their opinions. Analysis was descriptive.
Of 79 identified potential participants, 60 (76%) participated, 40% of whom were from federal and provincial government; 3% were private insurers; 18%, 15%, and 8% were from health professional groups, consumer groups, and patient groups, respectively; 8% and 7% were from pharmaceutical and advertising industries, respectively. Opinions were highly polarized on the effects of DTCA on drug and health care use. Advertising and pharmaceutical industry respondents were generally positive, public sector, health professional and consumer groups generally negative. Over 80% believed DTCA leads to higher private and public drug costs and more frequent physician visits. Fewer judged billboards or television to be appropriate media for DTCA than magazines or the Internet, and most believed that children and adolescents should not be targeted.
Given the polarization observed within this survey, we examined how DTCA policy has evolved in Canada since 2001. The federal government has legislative authority over DTCA, but bears few of the additional costs potentially incurred through policy change. These fall to the provinces, which provide an eroding patchwork of public coverage for prescription drugs in the face of rapidly increasing costs. No new federal legislation has been tabled since 2001. However, considerable shifts in administrative policy have occurred, all supportive of expanded advertising. Thus, the law continues to be restrictive but its application less so.
Pharmaceutical sales representatives and patient safety: a comparative prospective study of information quality in Canada, France and the United States.
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.
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.
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Comment In: J Gen Intern Med. 2013 Nov;28(11):139423884603
Comment In: J Gen Intern Med. 2013 Nov;28(11):139523897129
