Paula Rausch

Methodological approaches to evaluate the impact of FDA drug safety communications.

BackgroundWhen the US FDA approves a new prescription drug there is still a great deal remaining to be learned about the safe and proper use of that product. When new information addressing these topics emerges post-approval, the FDA may issue a Drug Safety Communication (DSC) to alert patients and physicians. The effectiveness of the communication—how drug safety messaging conveyed in FDA DSCs changes patient or prescriber behavior—may depend on multiple factors, including the way physicians and patients learn about the information, their understanding of the issues conveyed, and their perception of the importance of the information. In 2013, the FDA issued two DSCs addressing critical new warnings related to products containing the sedative/hypnotic zolpidem.ObjectiveIn this article, we describe a core set of research initiatives that can be used to study how zolpidem-related DSCs affected subsequent physician and patient decision making.MethodsThese research initiatives include analyzing drug utilization patterns and related health outcomes; comparing zolpidem-containing products against a comparator with similar indications [eszopiclone (Lunesta)] not covered by the 2013 DSCs; and surveying patients and qualitatively evaluating the dissemination of information regarding these drugs in traditional and social-media channels.ConclusionsUsing an integrated, multidisciplinary approach, we can obtain information that can be used to optimize regulatory communications by seeking to understand the impact of the information contained in FDA risk communications.

Media Coverage of FDA Drug Safety Communications about Zolpidem: A Quantitative and Qualitative Analysis

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.

Patient and Physician Perceptions of Drug Safety Information for Sleep Aids: A Qualitative Study

IntroductionThe US Food and Drug Administration uses drug safety communications (DSCs) to release emerging information regarding post-market safety issues, but it is unclear the extent of awareness by patients and providers of these communications and their specific recommendations.ObjectiveWe conducted semi-structured interviews with patients and physicians to evaluate their awareness and understanding of emerging drug safety information related to two sleep aids: zolpidem or eszopiclone.MethodsWe conducted interviews with 40 patients and ten physicians recruited from a combination of insurer claims databases and online sources. We evaluated (1) sources of drug safety information; (2) discussions between patients and physicians about the two medications; (3) their knowledge of the DSC; and (4) preferences for learning about future drug safety information. Interviews were transcribed and analyzed thematically.ResultsPatients cited their physicians, pharmacy inserts, and the Internet as sources of drug safety information. Physicians often referred to medical journals and online medical sources. Most patients reported being aware of information contained in the DSC summaries they were read. Almost all patients and physicians reported discussing side effects during patient-provider conversations, but almost no patients mentioned that physicians had communicated with them key messaging from the DSCs at issue: the risk of next-morning impairment with zolpidem and the lower recommended initial dose for women.ConclusionsSome risks of medications are effectively communicated to patients and physicians; however, there is still a noticeable gap between information issued by the Food and Drug Administration and patient and physician awareness of this knowledge, as well as patients’ decisions to act on this information. Disseminators of emerging drug safety information should explore ways of providing user-friendly resources to patients and healthcare professionals that can update them on new risks in a timely manner.

A quantitative approach to segmentation for prescription drug safety programs

Purpose The aim of this paper is to enhance the effectiveness of pharmacovigilance programs that provide information about medical products to benefit consumers, aid health care professional’s decision-making and improve community health. This research sought to determine whether distinct segments of consumers can be identified for prescription drug safety social marketing and communication activities and if these segments would respond differently to information about prescription drug products. Design/methodology/approach Theories of risk information-seeking behavior were used to develop questions for respondents in an online survey panel. Latent class analyses identified clusters that were similar in their ability to accurately interpret risks and benefits, preferred sources of health information, medication use and other related factors. Multinomial logistic regression models identified demographic and psychographic differences across the segments. Logistic and linear regression models were then used to compare each segment’s responses to a specific drug safety information product. Findings The 1,244 respondents were clustered into four segments: not engaged (12 per cent), low-involvement users (29 per cent), careful users (50 per cent) and social information seekers (9 per cent). These segments were distinguished by perceived seeking control, self-appraisal of skill, information insufficiency, self-efficacy, information competency and health literacy. Sources of health information and health-seeking behaviors were also different across the four segments. Significant differences were found among the segments in their comprehension and perceived utility of the content and their intentions to take relevant actions. Practical implications From an array of potential behavioral influences, adults can be segmented by risk information-seeking constructs and related behaviors. These segments respond differently to drug safety information. Use of the personas developed in this work can help pharmacovigilance programs around the world develop more relevant and tailored social marketing products, services and content. Originality/value A social marketing approach using empirically tested theoretical constructs can be useful for drug safety or pharmacovigilance programs. The results were used to create personas that quickly convey relevant information to drug safety program managers and staff.