Background: Effective drugs are essential to the health and well-being of the U.S. public. Thus, ensuring the safe use of drugs has become a public health imperative, as has communicating timely and accurate information about them. The Center for Drug Evaluation and Research (CDER) within the U.S. Food and Drug Administration (FDA) develops and issues approximately 35 Drug Safety Communications (DSCs) annually. DSCs are the primary communication tool for conveying important emerging risk information on post-market drug safety to various external audiences, including the lay public, caregivers, health care professionals, and other stakeholders.
Program background: CDER conducted in-depth, mixed-methods analyses to better understand the market penetration and “behavior” of these drug safety risk messages. Using mainstream and social media monitoring and analytics, behavior was assessed on three characteristics determined to be critical to effective risk communications: duration, dissemination, and diffusion.
Evaluation Methods and Results: The study involved the statistical analyses of 48 DSCs released over a two-year period, exploring the print and online media outlet behaviors they generated. Of these, 42 DSCs were analyzed retrospectively and six were tracked and analyzed immediately upon their release in “real time,” using advanced social media listening tools. To better understand consumers’ perceptions of DSC content, the study also included a series of focus groups with healthcare professionals and members of the general public. The effort also included a thorough internal audit of CDER’s processes for communicating drug safety risk information via interviews with CDER personnel and the FDA Drug Safety Oversight Board. Analyses of both quantitative (regression, correlation, and factor analyses) and qualitative data provide the evidence base for our conclusions.
Conclusions: Results from media monitoring indicated that all DSCs behaved similarly over time in the media, with activity peaking within the first two days of release and then sharply declining. However, each DSC displayed its own fingerprint – how, when, and where it was “picked up” in the media and by what media outlets. The most significant driver of message behavior was media “chatter” about the topic before DSC release, even discussion unrelated to the specific safety issue being communicated and regardless of whether its tone was positive or negative. The statistical analysis concluded that several key levers within the message content and layout are available for FDA to manipulate to, in turn, influence media coverage and increase message dissemination, duration, and diffusion.
Implications for research and/or practice: This initiative showed that changes to health messages – such as inclusion of information targeted to particular stakeholders, layout modification, descriptive titles and headings, and active phrasing of key points – have potential to produce large impacts on message spread. Contemporaneous tracking of messages also allows communicators to intervene in real time in an effort to increase the success of communications and ensure accurate messaging is being disseminated through external channels. FDA is using the results of this research to enhance its DSCs and other risk communications, but these findings are also relevant for improving content, dissemination, and overall impact of other health communications.