Implied Claims in Drug Advertising: A Review of Recent Literature and Regulatory Actions.

Federal agencies and self-regulatory bodies help to ensure prescription and nonprescription drug promotion contains accurate information; however, false or misleading claims may cause people to have inaccurate perceptions of a drug and inhibit their ability to make informed decisions. We conducted a systematic review assessing evidence from 2012-2021 on how consumers and healthcare providers (HCPs) interpret claims made indirectly or through inference (implied or implicit claims) as well as synthesizing prescription and nonprescription drug advertising claims that have been the subject of regulatory actions from 2017-2021. Our search identified 16 studies from the peer-reviewed literature and 26 letters or case reports issued by the Food and Drug Administration (FDA) or National Advertising Division (NAD). Results from peer-reviewed studies suggest that implied claims can result in inferences that may not be warranted by the material facts about the drug. Perceptions of a drug's efficacy and, to a lesser extent, risk, are influenced by implied and explicitly false claims in prescription drug promotion. Claims related to implied superiority and overstatement of efficacy were the most prevalent claims flagged for review and examined in the literature. These types of claims were also the subject of many of the compliance actions by the FDA and case reports from the NAD. More research is needed to understand how people interpret varying types of implied claims and the impact of such claims on key outcomes. From a policy standpoint, understanding how people interpret implied claims can inform how the FDA approaches these claims in the marketplace.

Who are vaccine champions and what implementation strategies do they use to improve adolescent HPV vaccination? Findings from a national survey of primary care professionals.

BACKGROUND: Implementation science researchers often cite clinical champions as critical to overcoming organizational resistance and other barriers to the implementation of evidence-based health services, yet relatively little is known about who champions are or how they effect change. To inform future efforts to identify and engage champions to support HPV vaccination, we sought to describe the key characteristics and strategies of vaccine champions working in adolescent primary care. METHODS: In 2022, we conducted a national survey with a web-based panel of 2527 primary care professionals (PCPs) with a role in adolescent HPV vaccination (57% response rate). Our sample consisted of pediatricians (26%), family medicine physicians (22%), advanced practice providers (24%), and nursing staff (28%). Our survey assessed PCPs' experience with vaccine champions, defined as health care professionals "known for helping their colleagues improve vaccination rates." RESULTS: Overall, 85% of PCPs reported currently working with one or more vaccine champions. Among these 2144 PCPs, most identified the champion with whom they worked most closely as being a physician (40%) or nurse (40%). Almost all identified champions worked to improve vaccination rates for vaccines in general (45%) or HPV vaccine specifically (49%). PCPs commonly reported that champion implementation strategies included sharing information (79%), encouragement (62%), and vaccination data (59%) with colleagues, but less than half reported that champions led quality improvement projects (39%). Most PCPs perceived their closest champion as being moderately to extremely effective at improving vaccination rates (91%). PCPs who did versus did not work with champions more often recommended HPV vaccination at the earliest opportunity of ages 9-10 rather than later ages (44% vs. 33%, p < 0.001). CONCLUSIONS: Findings of our national study suggest that vaccine champions are common in adolescent primary care, but only a minority lead quality improvement projects. Interventionists seeking to identify champions to improve HPV vaccination rates can expect to find them among both physicians and nurses, but should be prepared to offer support to more fully engage them in implementing interventions.

Complexity of Data Displays in Prescription Drug Advertisements for Healthcare Providers.

BACKGROUND: Healthcare providers (HCPs) often encounter clinical trial results in the form of data displays in prescription drug promotions. Information conveyed in data displays vary in their presentation and complexity. This study describes characteristics of data displays in prescription drug advertising targeted to HCPs. METHODS: This study characterized the content of 140 data displays in 98 unique print advertisements from 2009 to present and identified in AdPharm, an online database of pharmaceutical advertisements. Two reviewers independently coded the advertisements for characteristics (κ = 0.85) including complexity, format, and quality. RESULTS: About one-third (32%) of the advertisements contained multiple data displays (range 2 to 6) and 44% showed clinical data from oncology trials; other disease domains were mental and behavioral health (14%), rheumatology and autoimmune disorders (8%), endocrinology (7%), cardiology (6%), infectious disease (6%), pulmonology and allergy (4%), and others (< 2% each). About one-half (51%) of displays were classified as "simple" which included "pseudographs" and basic tables or charts. "Complex" displays appeared as survival curves, line graphs, or bar graphs with complex features. Most complex displays included a comparator drug (90%), plain language restatement of the key finding (93%) and disclosure statements (91%) with additional study details, although their placement varied. Complex displays were of high quality, according to our selected indicators; our analysis found no data distortion or errors. CONCLUSION: Data displays in prescription drug advertising are often highly complex. Future research assessing understanding of data displays and the potentially beneficial effect of disclosures and other features is warranted.

Healthcare providers' understanding of data displays of clinical trial information: a scoping review of the literature.

BACKGROUND: Healthcare providers often encounter clinical trial results in the form of visual data displays. Although there is a robust literature on patient responses to data displays in medical settings, less is known about how providers comprehend and apply this information. Our study provides a scoping review of the literature on providers' reactions to and perceptions of data displays. METHODS: We searched article databases (PubMed, PsycINFO, Web of Science, Cumulative Index to Nursing and Allied Health Literature, the Cochrane Library) supplemented by handsearching. Eligible articles were published in English from 1990 to 2020. RESULTS: We identified 15 articles meeting our criteria. Studies with physicians were more prevalent (13/15) than those with other healthcare providers (6/15). Commonly assessed outcomes included objective (10/15) and subjective comprehension (4/15), preference for certain data display formats (6/15), and hypothetical decision-making around prescribing (4/15). In studies that assessed comprehension of clinical trial concepts, scores were average or below what would be considered mastery of the information. Data display formats that were preferred did not always correlate with better comprehension of information; lesser preferred formats (e.g. icon array) often resulted in better comprehension. CONCLUSION: Our findings suggest that healthcare providers may not accurately interpret complex types of data displays, and it is unknown if such limitations affect actual decision-making. Interventions are needed to enhance comprehension of complex data displays within the context of prescription drug professional promotion.