Woloshin Steve, Schwartz Lisa M, Dejene Sara, Rausch Paula, Dal Pan Gerald J, Zhou Esther H, Kesselheim Aaron S
a Dartmouth Institute for Health Policy and Clinical Practice , Lebanon , New Hampshire , USA.
b Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School , Boston , Massachusetts , USA.
J Health Commun. 2017 May;22(5):365-372. doi: 10.1080/10810730.2016.1266717. Epub 2017 Mar 24.
FDA issues Drug Safety Communications (DSCs) to alert health care professionals and the public about emerging safety information affecting prescription and over-the-counter drugs. News media may amplify DSCs, but it is unclear how DSC messaging is transmitted through the media. We conducted a content analysis of the lay media coverage reaching the broadest audience to characterize the amount and content of media coverage of two zolpidem DSCs from 2013. After the first DSC, zolpidem news stories increased from 19 stories/week in the preceding 3 months to 153 following its release. Most (81%) appeared in the lay media, and 64% focused on the DSC content. After the second DSC, news stories increased from 24 stories/week in the preceding 3 months to 39 following. Among the 100 unique lay media news stories, at least half correctly reported three key DSC messages: next-day impairment and drowsiness as common safety hazards, lower doses for some but not all zolpidem products, and women's higher risk for impairment. Other DSC messages were reported in fewer than one-third of stories, such as the warning that impairment can happen even when people feel fully awake. The first-but not the second-zolpidem DSC generated high-profile news coverage. The finding that some messages were widely reported but others were not emphasizes the importance of ensuring translation of key DSC content.
美国食品药品监督管理局（FDA）发布药品安全通讯（DSC），以提醒医疗保健专业人员和公众注意影响处方药和非处方药的新出现的安全信息。新闻媒体可能会扩大DSC的传播范围，但目前尚不清楚DSC信息是如何通过媒体传播的。我们对面向最广泛受众的大众媒体报道进行了内容分析，以描述2013年两个唑吡坦DSC的媒体报道数量和内容。在第一次发布DSC后，唑吡坦的新闻报道从之前三个月的每周19篇增加到发布后的每周153篇。大多数报道（81%）出现在大众媒体上，64%的报道聚焦于DSC内容。在第二次发布DSC后，新闻报道从之前三个月的每周24篇增加到发布后的每周39篇。在100篇独特的大众媒体新闻报道中，至少一半正确报道了DSC的三个关键信息：次日功能损害和嗜睡是常见的安全风险、部分但并非所有唑吡坦产品的剂量降低以及女性功能损害风险更高。其他DSC信息在不到三分之一的报道中被提及，比如即使人们感觉完全清醒也可能发生功能损害的警告。第一次唑吡坦DSC引发了备受瞩目的新闻报道，但第二次没有。一些信息被广泛报道而其他信息未被报道这一发现强调了确保关键DSC内容得到传播的重要性。
