Aikin Kathryn J, Sullivan Helen W, Dolina Suzanne, Lynch Molly, Squiers Linda B
Office of Prescription Drug Promotion, Center for Drug Evaluation, US Food and Drug Administration, Silver Spring, MD, United States.
RTI International, Research Triangle Park, NC, United States.
J Med Internet Res. 2017 Jul 4;19(7):e225. doi: 10.2196/jmir.7306.
US Food and Drug Administration (FDA) regulations state that any prescription drug promotion that presents drug benefits to consumers must also disclose certain information about the drug's risks in a similar manner. Nearly three-quarters of all US mobile phone subscribers use a smartphone, and over half report receiving mobile advertisements on their device.
The objective of this project was to investigate how prescription drugs are being promoted to consumers using mobile technologies. We were particularly interested in the presentation of drug benefits and risks, with regard to presence, placement, and prominence.
We analyzed a sample of 51 mobile promotional communications and their associated linked landing pages. We assessed the content and format of the mobile communications and landing pages with regard to presentation of drug benefits and risks.
Of the 51 mobile communications we coded, 41% (21/51) were product claim communications (includes the drug name, benefits, and risks), 22% (11/51) were reminder communications (includes drug name only), and 37% (19/51) were help-seeking communications (includes information about the medical condition but not the drug name). Some of the product claim communications (5/21, 24%) required scrolling to see all the benefit information; in contrast, 95% (20/21) required scrolling to see all the risk information. Of the 19 product claim communications that presented both benefits and risks, 95% (18/19) presented benefits before risks and 47% (9/19) used a bigger font for benefits than for risks. Most mobile communications (35/51, 69%) linked to branded drug websites with both benefits and risks, 25% (13/51) linked to a landing page with benefits but no visible risks, and 6% (3/51) linked to a landing page with risks but no visible benefits. Few landing pages (4/51, 8%) required scrolling to see all the benefit information; in contrast, 51% (26/51) required scrolling to see all the risk information. Of the 35 landing pages with both benefit and risk information, 71% (25/35) presented benefits before risks and 51% (18/35) used a bigger font for benefits than for risks.
These results indicate that, while risks and benefits are both represented in mobile communications and their associated landing pages, they are not equally prominent and accessible. This has implications for compliance with FDA fair balance regulations.
美国食品药品监督管理局(FDA)规定,任何向消费者宣传药品益处的处方药推广活动,都必须以类似方式披露有关该药品风险的某些信息。近四分之三的美国手机用户使用智能手机,超过一半的用户报告在其设备上收到过移动广告。
本项目的目的是调查如何利用移动技术向消费者推广处方药。我们特别关注药品益处和风险的呈现方式,包括其存在情况、位置和突出程度。
我们分析了51条移动推广信息样本及其相关的链接着陆页。我们评估了移动信息和着陆页在药品益处和风险呈现方面的内容和格式。
在我们编码的51条移动信息中,41%(21/51)是产品声明信息(包括药品名称、益处和风险),22%(11/51)是提醒信息(仅包括药品名称),37%(19/51)是求助信息(包括有关医疗状况的信息但不包括药品名称)。一些产品声明信息(5/21,24%)需要滚动查看所有益处信息;相比之下,95%(20/21)需要滚动查看所有风险信息。在19条同时呈现益处和风险的产品声明信息中,95%(18/19)先呈现益处后呈现风险,47%(9/19)用于呈现益处的字体比呈现风险的字体更大。大多数移动信息(35/51,69%)链接到既有益处又有风险的品牌药品网站,25%(13/51)链接到只有益处而无明显风险的着陆页,6%(3/51)链接到只有风险而无明显益处的着陆页。很少有着陆页(4/51,8%)需要滚动查看所有益处信息;相比之下,51%(26/51)需要滚动查看所有风险信息。在35条既有益处又有风险信息的着陆页中,71%(25/35)先呈现益处后呈现风险,51%(18/35)用于呈现益处的字体比呈现风险的字体更大。
这些结果表明,虽然风险和益处在移动信息及其相关着陆页中都有体现,但它们的突出程度和易获取程度并不相同。这对遵守FDA的公平平衡规定有影响。