Disease Awareness and Prescription Drug Communications on Television: Evidence for Conflation and Misleading Product Impressions.

We conducted two experiments that tested for conflation of fictitious disease awareness and prescription drug promotional communications in a television advertising context and whether similarity, proximity, and number of exposures to the disease awareness communication contributed to this conflation. Study 1 involved a 1-h television segment, and Study 2 used a longitudinal design with participants exposed to communications over time. The promoted product was indicated to treat asthma. Participants (Study 1, n = 2190; Study 2, n = 1621) were adults who had experienced asthma or asthma symptoms. In Study 1, mere exposure to disease awareness communication prompted benefit and risk conflation, but the degree of similarity or proximity did not have an effect. In Study 2, similar ads prompted greater conflation of benefits than distinct ads, and greater conflation of risks occurred with greater proximity to disease awareness and promotional communications. In addition, asthma knowledge, health literacy, and perceived ad effectiveness increased conflation of benefits in both studies but tended not to modify the impact of similarity or proximity. The findings demonstrate the potential for disease awareness communications to confuse consumers regarding the benefits and risks of a drug.

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.

A scoping review of empirical research on prescription drug promotion.

BACKGROUND: Pharmaceutical spending on prescription drug promotion is considerable, and exposure to advertising can influence demand and behavior. The U.S. Food and Drug Administration (FDA) provides industry guidance to help ensure that communications to consumers and health care providers about prescription drug promotion are truthful, balanced, and accurately communicated. As empirical research has accelerated on this topic in the past decade, an understanding of the current landscape of the science will help inform future research. OBJECTIVES: Using systematic methods, this rigorous scoping review of the literature over the past decade (2012-2021) (1) examined the extent to which prescription drug promotion has been empirically investigated with consumers, patients, and health care providers; (2) examined the extent to which content and features of prescription drug promotion have been empirically investigated; and (3) identified themes across the literature to better understand the current landscape of prescription drug promotion. METHODS: Databases searched include PubMed, Web of Science, CINAHL, APA PsycInfo, Business Source Corporate, Communication Source, Cochrane Library, and ClinicalTrials.gov for original research published in English from January 1, 2012, through November 10, 2021, using terms related to direct-to-consumer advertising, prescription drugs, and outcomes of interest (e.g., attitudes, perceptions, intentions, behaviors). RESULTS: Of 804 screened references, 151 studies addressed the first research question, and 40 studies addressed the second. The most common theme across the body of evidence focused on testing of features and content in prescription drug promotional materials (84), followed by studies examining attitudes, perceptions, and behaviors toward prescription drug promotion more generally (43). Some (27) studies focused on targeted populations, such as patients, the elderly, non-English speaking people or individuals of a non-white race/ethnicity. Twenty-four studies assessed influence of exposure to prescription drug promotion on actual clinical outcomes, while 11 studies examined emerging technologies around prescription drug promotion. Seven studies evaluated the extent to which prescription drug promotion complied with existing guidelines and requirements. CONCLUSIONS: Findings from this scoping review suggest there has been an increase in the number of empirical studies conducted on prescription drug promotion over the past decade. Potential areas that warrant further study include examination of emerging technologies, an expanded focus on targeted populations, and construct measurement.

Detecting and Reporting Deceptive Prescription Drug Promotion: Differences Across Consumer and Physician Audiences and by Number and Type of Deceptive Claims and Tactics.

The U.S. Food and Drug Administration's (FDA) Bad Ad program provides an avenue for healthcare providers to report false or misleading prescription drug promotion. Yet, whether healthcare providers can detect such promotion, and whether they believe it should be reported to FDA, remain open questions. Consumer audiences may also be capable of detecting such promotion and believe it should be reported, but even less is known about capability and belief in this population. Across two experiments using mock pharmaceutical websites, this research investigated capability to detect and inclination to report deceptive prescription drug promotion among a sample of primary care physicians and consumers. Study 1 varied the number of deceptive claims and tactics on a website for a chronic pain medication, operationalized as none, two, or five. Study 2 varied the type of deceptive content on a website for a weight loss medication, operationalized as none, implicit, or explicit. Findings reveal that, in line with expectations from FDA's Bad Ad program, physicians can detect deceptive promotion and tend to believe it should be reported. Consumers are also capable of detecting deceptive promotion and tend to believe it should be reported, but their capabilities and beliefs regarding reporting are generally lower.

Utilization of adequate provision in prescription drug broadcast ads among low- and non-Internet users.

To fulfill a key regulation pertaining to prescription drug broadcast advertising, a common practice is to present the major risks along with "adequate provision" referencing several sources where audiences can obtain the full product labeling. In recent years, questions have arisen about the unique value of the various sources of adequate provision and even whether sponsor webpages alone may sufficiently convey product labeling information. Cognizant of the sizable offline population, the present research investigates questions of access, ability, likelihood, willingness, and preference among a nationally representative sample of low- and non-Internet users who may wish to access the product labeling.

Assessing the Inclusion of Foil Items in a Scale to Measure Recognition of Health Messages.

Researchers frequently measure recognition of information in health messages by presenting participants with statements that were or were not in a message and then asking them to identify which were presented and which were not. Recognition scales are then calculated by summing the correct responses to both the true items and foils, or by summing the correct responses to the true items only. We used a sequence of psychometric analyses, including factor analysis and item response theory (IRT) analysis, to evaluate two recognition measures of this type, using data from previously published studies. We found that foils are less associated with true items than true items are with one another, or more practically, that foils are less associated with the underlying dimension of interest. These results provide researchers with insight into how recognition items function, as well as a better analytic approach for use in future studies.

Experimental evidence of consumer and physician detection and rejection of misleading prescription drug website content.

BACKGROUND: Consumers and primary care physicians (PCPs) sometimes encounter deceptive promotional claims about prescription drugs. Whether consumers and PCPs can detect deceptive claims or whether those claims negatively affect medical decision making, however, remain important, unanswered research questions. OBJECTIVES: This article explores (1) the ability of consumers and PCPs to identify deceptive prescription drug promotion at various levels of deception, (2) the influence of such tactics on obstructing risk recognition, and (3) whether perceived deception mediates relationships between exposure to deceptive tactics and various outcomes (including false-claim acceptance, attitudes, information-seeking intentions, and interest toward the promoted drug). METHODS: Two experiments-1 with consumers (N = 366) and 1 with PCPs (N = 378)-were conducted to determine whether participant exposure to deceptive prescription drug website content corresponds to detection and acceptance (or rejection) of claims and tactics. In each experiment, the number of deceptive claims and tactics on a consumer- or PCP-targeted website for a fictitious chronic pain medication were varied, in a 1 × 3 (none, fewer, more) between-subjects design. RESULTS: Among consumers, exposure to more deceptive claims or tactics did not increase suspicion about the veracity of the website (relative to fewer claims and tactics) and actually had a limited positive direct effect on false-claim acceptance and attitudes toward the drug. Among PCPs, a mediation effect existed such that exposure to more deceptive claims and tactics resulted in higher perceived website deceptiveness relative to those in the fewer deceptive claims condition, which, in turn, resulted in lower acceptance of deceptive claims and tactics, lower perceived drug effectiveness, more negative attitudes toward the drug, and lower interest and intentions. CONCLUSION: These experiments demonstrate potential differences between consumers and PCPs as well as implications for consumer and PCP vulnerability to website deception.

Consumer responses to framing statements preceding the major risk statement in prescription drug DTC TV ads.

BACKGROUND: Research on the major risk statement in direct-to-consumer (DTC) prescription drug television ads has shown that risk severity and actionability can affect consumers' risk comprehension and perceptions. A framing statement presented just before the major risk statement may serve as a cue that directs attention to the risk statement that follows, or it may guide consumers' interpretation of the severity of the risks that follow. OBJECTIVE: Examine how the use of different framing statements (severe, life-threatening; serious; or basic) that precede the major risk statement in DTC television ads affect consumers' risk perceptions, risk recognition, benefit perceptions, interest in the drug, and other relevant outcomes. METHODS: An online experiment was conducted using a 1 × 3 between-subjects design to compare three different framing statements, which was replicated across three different DTC television ads that focused on different medical conditions (arthritis, lung cancer, and type 2 diabetes). A sample of US adults (N = 1961) was randomly assigned to view one of nine television ads and asked to respond to a questionnaire. RESULTS: The type of framing statement had significant effects on perceived risk severity, perceived utility of risk and benefit information, fear of risks, and perceived likelihood of explicit and implicit benefits. CONCLUSIONS: Consumers pay attention to and use cues to process and interpret the risk information presented to them in DTC television ads. Using lead-in language that describes risk severity, particularly for products with severe, life-threatening risks, may better allow consumers to make evaluative judgments on risk severity in DTC ads than stating the drug can cause serious reactions or simply that reactions are possible. More work is needed to examine the factors that affect people's understanding of the nature of risk severity, particularly with regard to risk recognition.

Individual- and Ad-Level Predictors of Perceptions of Serious and Actionable Risks in Direct-to-Consumer Prescription Drug TV Advertising.

Prescription drug broadcast advertisements in the United States are required to present the product's major risks in at least the audio portion of the ad (21 CFR 202.1(e)(1)). This can result in a lengthy list of risks and side effects. The U.S. Food and Drug Administration has been studying the effects of limiting the major statement to those risks that are serious and actionable. We explore the level of agreement between consumers and experts regarding what risks and side effects are serious and actionable, and how variations in the content of major risk statement as well as other factors such as demographic variables, perceived accuracy of direct-to-consumer advertising, illness knowledge, and knowledge of prescription drug regulations, predict perceptions of risk and actionability. Participants (N = 1,000) self-diagnosed with depression or insomnia were randomly assigned to view a television ad for their respective condition that presented the full major statement or an edited version that included only serious and actionable risks. Results indicated consumers' perceptions of risk severity generally matched experts' assessment, but there was relatively less agreement about risk actionability. Results also varied as a function of income and gender.

Taking Repeated Exposure into Account: An Experimental Study of Direct-To-Consumer Prescription Drug Television Ad Effects.

Introduction: Little is known about how repeated exposure to direct-to-consumer prescription drug promotion can impact consumers' retention and perceptions of drug information. The study described here tested the effects of varied ad exposure frequency on these outcomes. Methods: In an in-person experiment, participants with seasonal allergies (n = 616) were randomized to view a mock prescription drug television ad either once, twice, or four times within 1 h of television programming, embedded with six commercial breaks. Respondents then answered a 20-min survey administered via computer. Results: Those who viewed the ad more frequently were better able to recall both risk (X2 = 20.93, p < .001) and benefit information (X2 = 9.34, p = .009) and to recognize risk (F(2,597) = 11.89, p = .001) and benefit information (F(2,597) = 3.17, p = .043) than those who viewed the ad one time. Ad exposure frequency was not associated with perceptions about the magnitude or likelihood of risks or benefits. In general, risk information seemed to require more repetitions than benefit information to be accurately remembered. The recall was mediated by elaborate processing. Discussion: Effects on memory were small; retention of both risks and benefits remained low overall even after four exposures.

Consumer tradeoff of advertising claim versus efficacy information in direct-to-consumer prescription drug ads.

BACKGROUND: Consumers' decision making about prescription drugs may be influenced by more than thoughts about drug efficacy and the potential for side effects. Choices may be based on tradeoffs among multiple factors, for example, medical condition, risk severity, risk likelihood, product efficacy, and resources. Some information used in tradeoff choices might be derived from marketing efforts by drug manufacturers. How market claims, such as "#1 Prescribed" may affect this tradeoff is an area that has yet to be explored fully. OBJECTIVE: Using conjoint analysis techniques, this research examined the tradeoff of market claim and efficacy information in direct-to-consumer (DTC) print advertising for prescription drugs. METHODS: Two hundred fifteen adult participants with a self-reported diagnosis of diabetes were recruited through an online consumer panel. Participants were presented a series of choices. Each choice pair represented a prescription diabetic nerve pain drug with a different efficacy level and one of the two had a market claim of "#1 Prescribed". Participants indicated which drug they would prefer if they had to choose one. Results showed an advantage of #1 Prescribed. A drug without this claim needed at least 1.23% greater efficacy to be chosen over a drug with this claim. CONCLUSIONS: Study findings align with previous research which found that extrinsic cues can influence consumer product choice, which has implications for optimal medication use.

Serious and actionable risks, plus disclosure: Investigating an alternative approach for presenting risk information in prescription drug television advertisements.

BACKGROUND: Broadcast direct-to-consumer (DTC) prescription drug ads that present product claims are required to also present the product's major risks. Debate exists regarding how much information should be included in these major risk statements. Some argue that such statements expose people to unnecessary amounts of information, while others argue that they leave out important information. OBJECTIVES: Examine the impact of type of risk statement (unedited versus serious and actionable risks only) and a disclosure indicating that not all risks are presented on consumers' ability to remember the important risks and benefits of a drug following exposure to a DTC television advertisement (ad). Risk and benefit perceptions, ad-prompted actions, recognition of the disclosure statement, and evaluations of both the disclosure and risk statement were also examined. METHODS: A web-based experiment was conducted in which US adults who self-reported as having depression (N = 500), insomnia (N = 500), or high cholesterol (N = 500) were randomly assigned to view one of four versions of the television ad, and then complete a questionnaire. RESULTS: The type of risk statement had a significant effect on risk recall and recognition, benefit recognition, perceived risk severity (depression condition only), and perceived benefit magnitude (high cholesterol condition only). Disclosure recognition (using bias-corrected scores) ranged from 63% to 70% across the three illness samples. CONCLUSIONS: The revised risk statement improved overall processing of the television ad, as evidenced by improved risk recall and recognition and improved benefit recognition. Further, the presence of the disclosure did not adversely affect consumers' processing of drug risk and benefit information. Therefore, limiting the risks presented in DTC television ads and including a disclosure alerting consumers that not all risks are presented may be an effective strategy for communicating product risks.

Physician Response to Contextualized Price-Comparison Claims in Prescription Drug Advertising.

Background: Physician-targeted prescription drug advertisements sometimes include price comparisons between products that may misleadingly imply equivalence of efficacy and safety or misrepresent true savings, suggesting the potential utility of a context statement to explain what the claims do and do not mean. Methods: We manipulated the presence of a price claim and a context statement in a 1 × 3 (control condition, price-comparison-only, price-comparison-plus-context) between-subjects design. Physicians (N = 1,438), randomly assigned to condition, viewed the prescription drug ad and answered a brief survey. Primary outcome measures included recognition, perceived importance, and impact of the price-comparison claim, and recognition, understanding, and effectiveness of the context statement. Results: The majority of physicians accurately recognized the price claim (76.0%) but far fewer accurately recognized the associated context statement (44.9%). The context statement did not affect evaluations of the price-comparison claim importance or accuracy and did not have the intended effects on perceptions of uncertainty about drug interchangeability. Physicians may be affected by price-comparison claims in thinking that the drug has risks that are relatively less severe. Price-comparison claims also affected intentions to look for information about the drug. Conclusions: Adding a realistic context statement to a physician-targeted prescription drug ad did not generate sufficient awareness of claim caveats to differentiate price-comparison response of those exposed to the context statement from those who were not.

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.

Consumer perceptions of prescription and over-the-counter drug advertisements with promotional offers.

Information on the effects of promotional offers in direct-to-consumer prescription drug ads is limited. In two studies, we examined the effect of promotional offers (e.g., money-back guarantee) and ad type (creating prescription and over-the-counter drug ads by varying the presence of benefit and risk information). We found little effect of promotional offers. Adding benefit (risk) information to the ad increased consumers' knowledge of the benefit (risk) information and their efficacy (risk) perceptions. In most cases, adding risk information to an ad with benefit information increased risk knowledge and perceptions without decreasing benefit knowledge or perceptions.

Consumers' Understanding of FDA Approval Requirements and Composite Scores in Direct-to-Consumer Prescription Drug Print Ads.

In 2 studies, we investigated how laypersons perceive the Food and Drug Administration (FDA) approval process, FDA authority, and the presentation of composite scores in direct-to-consumer (DTC) prescription drug print ads. The 1st study consisted of 4 focus groups (N = 38) in 2 cities. Using a semi-structured guide, a moderator led participants through the viewing of 3 existing DTC print ads that differed in the presence or absence of composite score information, and participants discussed their views of the ads and their understanding of composite scores. The 2nd study surveyed a nationally representative sample of 1,629 individuals from the general population who saw a fictitious DTC print ad and answered closed-ended questions about the same topics. Results showed that knowledge of FDA approval and authority was mixed, with several misconceptions apparent. Many consumers were not familiar with the use of composite scores in a medical context or in advertising and, in the 1st study, expressed distrust of the product and the ad after learning about how composite scores are used. In the 2nd study, receiving composite score information changed the perceived clarity of the ad but not the perceived risk or benefits. Implications for the presentation of complex medical information are discussed.

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.

Communicating efficacy information based on composite scores in direct-to-consumer prescription drug advertising.

OBJECTIVE: Drug efficacy can be measured by composite scores, which consist of two or more symptoms or other clinical components of a disease. We evaluated how individuals interpret composite scores in direct-to-consumer (DTC) prescription drug advertising. METHODS: We conducted an experimental study of seasonal allergy sufferers (n=1967) who viewed a fictitious print DTC ad that varied by the type of information featured (general indication, list of symptoms, or definition of composite scores) and the presence or absence of an educational intervention about composite scores. We measured composite score recognition and comprehension, and perceived drug efficacy and risk. RESULTS: Ads that featured either (1) the composite score definition alone or (2) the list of symptoms or general indication information along with the educational intervention improved composite score comprehension. Ads that included the composite score definition or the educational intervention led to lower confidence in the drug's benefits. The composite score definition improved composite score recognition and lowered drug risk perceptions. CONCLUSION: Adding composite score information to DTC print ads may improve individuals' comprehension of composite scores and affect their perceptions of the drug. PRACTICE IMPLICATIONS: Providing composite score information may lead to more informed patient-provider prescription drug decisions.

Disease Information in Direct-to-Consumer Prescription Drug Print Ads.

Direct-to-consumer (DTC) prescription drug advertisements sometimes include information about the disease condition in addition to information about the advertised product. Although the intent of such information is to educate about the disease condition, in some cases consumers may mistakenly assume that the drug will address all of the potential consequences of the condition mentioned in the ad. We investigated the effects of adding disease information to DTC prescription drug print ads on consumer product perceptions and understanding. Participants (4,064 adults) viewed 1 of 15 DTC print ads for fictitious prescription drugs indicated to treat chronic obstructive pulmonary disease, anemia, or lymphoma that varied in disease information presence, type, and format. Participants answered questions that assessed risk and benefit memory, perception, and behavioral intention. Results indicate that exposure to disease information as part of DTC prescription drug ads can promote the impression that the drug addresses consequences of the condition that are not part of the drug's indication.

Who Said It Better? A Test of Wording Differences in the MedWatch "Toll-Free Statement" for Consumer Reporting of Side Effects in Direct-to-Consumer Television Advertisements.

BACKGROUND: A toll-free statement alerting consumers how to report side effects to the US Food and Drug Administration (FDA) is required for both prescription drug labeling and direct-to-consumer (DTC) print ads. Because of different regulatory requirements between these materials (the Toll-free Number for Reporting Adverse Events on Labeling for Human Drug Products Rule [TFNR] versus the FDA Amendments Act [FDAAA], respectively), the wording of this statement differs. We studied how statement wording for reporting side effects to FDA in DTC television ads affects comprehension of product risks and benefits, comprehension of and memory for the toll-free statement, and perceived statement clarity. METHODS: Participants viewed 1 of 8 mock prescription drug television ads that varied the wording and placement of the toll-free statement, and then responded to a questionnaire. RESULTS: The FDAAA statement was more noticeable, clear, and more participants were able to recall and recognize its correct purpose. Comprehension of product risk and benefit information did not differ based on statement wording. CONCLUSIONS: Findings suggest that the FDAAA toll-free statement wording is superior to that of the TFNR.