医药代表与患者安全：加拿大、法国和美国的医药代表信息质量比较前瞻性研究。
Pharmaceutical sales representatives and patient safety: a comparative prospective study of information quality in Canada, France and the United States.
机构信息
School of Population and Public Health, University of British Columbia, #307, 2176 Health Sciences Mall, Vancouver, British Columbia, V6T 1Z3, Canada,
出版信息
J Gen Intern Med. 2013 Oct;28(10):1368-75. doi: 10.1007/s11606-013-2411-7. Epub 2013 Apr 5.
INTRODUCTION
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.
DISCUSSION
"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.
简介
药品销售代表提供的信息已被证明会影响处方。为了确保安全用药，药品信息必须包含益处和危害。监管支持这一目标，但不同方法的相对有效性尚不清楚。美国和法国直接监管药品促销；加拿大则依赖行业自律。法国的信息标准最为严格。
方法
这是一项在美国蒙特利尔、温哥华、萨克拉门托和图卢兹进行的前瞻性队列研究。我们于 2009 年 5 月至 2010 年 6 月招募了初级保健医生的随机样本，以报告连续的销售访问情况。主要结局指标是“基本充分的安全性信息”（至少提及一种适应证、严重不良事件、常见不良事件和禁忌证，且无不合格的安全性声明或未经批准的适应证）。
结果
255 名医生报告了 1692 种药物的特定促销活动。“基本充分的安全性信息”无差异：每个地点的促销活动中，有 1.7%（范围为 0.9%-3.0%）提供了该信息。与蒙特利尔和温哥华相比，图卢兹的销售代表更常提供一些危害信息而不是没有：61%比 34%，比值比（OR）=4.0；95%置信区间（CI）为 2.8-5.6，或萨克拉门托（39%），OR=2.4；95%CI 为 1.7-3.6。严重不良事件很少提及（四个地点的所有促销活动中均有 5%-6%提及），尽管 45%的促销活动涉及有美国食品和药物管理局（FDA）“黑框”警告严重风险的药物。尽管如此，901 次促销活动（54%）中医生认为科学信息质量良好或优秀，并表示有 64%的时间愿意开具处方。
讨论
尽管监管存在差异，但美国和加拿大的研究点之间的“基本充分的安全性信息”没有差异。在图卢兹，与更严格的标准一致，提供了更多的危害信息。然而，在所有地点，医生很少被告知严重不良事件，这引发了关于当前监管销售代表的方法是否充分保护患者健康的问题。
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