Amie C. O'Donoghue

Communicating quantitative risks and benefits in promotional prescription drug labeling or print advertising

Under the Food, Drug, and Cosmetic Act, all promotional materials for prescription drugs must strike a fair balance in presentation of risks and benefits. How to best present this information is not clear. We sought to determine if the presentation of quantitative risk and benefit information in drug advertising and labeling influences consumers’, patients’, and clinicians’ information processing, knowledge, and behavior by assessing available empirical evidence.

Preferences for Patient Medication Information: What Do Patients Want?

This study investigated respondent preferences on how best to display patient medication information (PMI) that accompanies prescription medications to promote comprehension and appropriate usage. The authors identified 30 individuals diagnosed with select immune disorders, 30 with other chronic diseases, and 30 from the general public and had them review one of two PMI handouts that varied by format, organization, and content. The authors explored preferences for the PMI handout using one-on-one interviews. The authors analyzed the qualitative data to identify relevant themes and patterns using NVivo9 qualitative software. The majority of respondents noted that the formats of the two PMI handouts were more informative than those they currently receive from the pharmacist, with a preference for the 2-column, segmented design. However, respondent PMI preferences varied by age, education, and health status. Patients need simpler and more concise drug information to make better decisions about their health. Current PMI handouts are dense and complex, which can be confusing and not reader friendly. To improve PMI understandability and usefulness, the U.S. Food and Drug Administration is working with stakeholders, consumer advocates, and academics. Findings from this study may help inform future development of more user-friendly PMI.

Correction of misleading information in prescription drug television advertising: The roles of advertisement similarity and time delay

Background: Prescription drug television advertisements containing potentially consequential misinformation sometimes appear in the United States. When that happens, the U.S. Food and Drug Administration can request that companies distribute corrective advertisements to address misinformation and inaccurate claims. Previous research has demonstrated effectiveness in corrective advertising for various products. Objectives: The present article builds on that work with a randomized experimental study (n = 6454) of corrective advertising investigating the extent to which visual similarity matters between violative and corrective ads and the extent to which time delay matters between violative and corrective advertisement exposure. Methods: Our study sample included overweight or obese U.S. adults recruited from an existing online consumer panel representative of the U.S. adult population. We created a brand for a fictitious prescription weight‐loss drug and produced corresponding direct‐to‐consumer (DTC) television ads. All participants viewed the same violative ad, but were randomly assigned to view corrective ads with different levels of visual similarity and exposure time delay using a 4 × 4 between‐subjects factorial design. Results: Results suggest corrective ad exposure can influence consumer perceptions of drug efficacy, risks, and benefits previously established by violative ads that overstated drug efficacy, broadened drug indication, and omitted important risk information. Corrective ads also can weaken consumer intentions to consider and investigate a drug. However, ad similarity does not appear to affect consumer perceptions and preferences. Although we found that the effects of violative ad exposure tend to diminish over time, the length of the delay between violative and corrective ad exposure has limited influence. An exception to this was observed with regard to recall of drug benefits and risks, where the impact of corrective ad exposure increases with greater time delay. Conclusions: These results extend previous research to a new health condition and hold implications for regulatory policy.

Assessing hearing and cognition challenges in consumer processing of televised risk information: Validation of self-reported measures using performance indicators

Public health researchers face important challenges if they wish to include measures of hearing or cognitive ability in risk communication studies. We sought validity evidence for self-report measures of hearing and cognitive ability by comparing those measures to performance-based measures and risk information recall. We measured hearing ability (with audiologist-assisted assessment and self report), cognitive ability (with an established performance task and self report), and reactions to direct-to-consumer prescription drug promotion with adults 18 and older (n = 1064) in North Carolina, USA, in 2017. We found moderate correspondence between self-reported hearing loss and audiologist-assessed hearing loss. Both measures also showed a small negative association with recall of presented risk information. Cognitive ability results suggested less substantial correspondence between self report and performance task and the measures differed in predicting risk recall. Our results suggested a moderately efficient measure for hearing ability for research on risk information exposure and retention, and yet also suggested the need for caution regarding future use of self-reported cognitive ability as a substitute for a performance-based measure.

Professional online community membership and participation among healthcare providers: An extension to nurse practitioners and physician assistants

BACKGROUND AND PURPOSE Professional online communities allow healthcare providers to exchange ideas with their colleagues about best practices for patient care. Research on this topic has focused almost exclusively on primary care physicians and specialists, to the exclusion of advanced practice providers such as nurse practitioners and physician assistants. We expand this literature by examining membership and participation on these websites among each of these provider groups. METHODS Participants (N = 2008; approximately 500 per provider group) responded to an Internet-based survey in which they were asked if they use professional online communities to dialogue with colleagues and if so, what their motivation is for doing so. CONCLUSIONS Nearly half of the participants in our sample reported utilizing professional online communities. Select differences were observed between provider groups, but overall, similar patterns emerged in their membership and participation on these websites. IMPLICATIONS FOR PRACTICE Nurse practitioners and physician assistants utilize professional online communities in similar proportion to primary care physicians and specialists. Providers should be cognizant of the impact this use may have for both themselves and their patients. Researchers are urged to take into account the various professional roles within the healthcare community while developing research on this topic.

Disclosing accelerated approval on direct-to-consumer prescription drug websites

We examined direct‐to‐consumer (DTC) websites for brand‐name accelerated approval prescription drugs to determine whether and how accelerated approval is communicated to consumers.

Testimonials and Informational Videos on Branded Prescription Drug Websites: Experimental Study to Assess Influence on Consumer Knowledge and Perceptions

Background Direct-to-consumer (DTC) promotion of prescription drugs can affect consumer behaviors and health outcomes, and Internet drug promotion is growing rapidly. Branded drug websites often capitalize on the multimedia capabilities of the Internet by using videos to emphasize drug benefits and characteristics. However, it is unknown how such videos affect consumer processing of drug information. Objective This study aimed to examine how videos on prescription drug websites, and the inclusion of risk information in those videos, influence consumer knowledge and perceptions. Methods We conducted an experimental study in which online panel participants with acid reflux (n=1070) or high blood pressure (n=1055) were randomly assigned to view 1 of the 10 fictitious prescription drug websites and complete a short questionnaire. On each website, we manipulated the type of video (patient testimonial, mechanism of action animation, or none) and whether the video mentioned drug risks. Results Participants who viewed any video were less likely to recognize drug risks presented only in the website text (P≤.01). Including risk information in videos increased participants’ recognition of the risks presented in the videos (P≤.01). However, in some cases, including risk information in videos decreased participants’ recognition of the risks not presented in the videos (ie, risks presented in text only; P≤.04). Participants who viewed a video without drug risk information thought that the website placed more emphasis on benefits, compared with participants who viewed the video with drug risk information (P≤.01). Compared with participants who viewed a video without drug risk information, participants who viewed a video with drug risk information thought that the drug was less effective in the high blood pressure sample (P=.03) and thought that risks were more serious in the acid reflux sample (P=.01). There were no significant differences between risk and nonrisk video conditions on other perception measures (P>.05). In addition, we noted a few differences among the types of videos. Conclusions Including risks in branded drug website videos may increase in-video risk retention at the expense of text-only risk retention.

Awareness of the Food and Drug Administration's Bad Ad Program and Education Regarding Pharmaceutical Advertising: A National Survey of Prescribers in Ambulatory Care Settings

The U.S. Food and Drug Administrations Bad Ad program educates health care professionals about false or misleading advertising and marketing and provides a pathway to report suspect materials. To assess familiarity with this program and the extent of training about pharmaceutical marketing, a sample of 2,008 health care professionals, weighted to be nationally representative, responded to an online survey. Approximately equal numbers of primary care physicians, specialists, physician assistants, and nurse practitioners answered questions concerning Bad Ad program awareness and its usefulness, as well as their likelihood of reporting false or misleading advertising, confidence in identifying such advertising, and training about pharmaceutical marketing. Results showed that fewer than a quarter reported any awareness of the Bad Ad program. Nonetheless, a substantial percentage (43%) thought it seemed useful and 50% reported being at least somewhat likely to report false or misleading advertising in the future. Nurse practitioners and physician assistants expressed more openness to the program and reported receiving more training about pharmaceutical marketing. Bad Ad program awareness is low, but opportunity exists to solicit assistance from health care professionals and to help health care professionals recognize false and misleading advertising. Nurse practitioners and physician assistants are perhaps the most likely contributors to the program.