Prescription drug regulations require a fair balance of the content and prominence of risk and benefit information in prescription drug product claim promotion. The rise of Internet communications that have character space limitations, such as sponsored link promotion and microblog messaging, has led to questions about how to use these communications for prescription drug promotion while complying with the fair balance requirements. In 2014, FDA released draft guidance, “Guidance for Industry Internet/Social Media Platforms with Character Space Limitations — Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices” which states:
Regardless of character space constraints that may be present on certain Internet/social media platforms, if a firm chooses to make a product benefit claim, the firm should also incorporate risk information within the same character-space-limited communication. The firm should also provide a mechanism to allow direct access to a more complete discussion of the risks associated with its product.
This project was designed to address the question of whether substantive risk information in the character-space-limited (CSL) communications is effective in communicating risks when benefit claims are made, or whether a link to the risk information is sufficient. Within each study, we manipulated whether or not substantive risk information appears in the character-space-limited communication. In four studies, participants viewed the study search page once without prompting to pay attention to the CSL communication and a second time with prompting. Few participants clicked the link in the CSL communication the first time they saw it. Participants were more likely to recognize the substantial risk after the first viewing if the substantial risk was included in the CSL communication. The findings from the second viewing, when participants’ attention was focused on the CSL communication, add a caveat: if people are explicitly looking for information about the drug by reading the CSL communication, they may be less likely to click a link for further risk information if there is a substantial risk in the CSL communication. These results provide a first look at the tradeoffs for consumer understanding of drug risks and benefits when drugs are promoted in CSL communications.
To fulfill the regulatory requirements for fair balance and the brief summary, sponsors have typically included risk information about the product in DTC print ads both in the main part of the ad where the product claims appear, and in a separate brief summary page. The section of the main ad where the risks appear is often referred to as the "Important Safety Information" (ISI). Including risks in both the ISI and the brief summary may have advantages. However, a potential downside to including the same warnings in both the ISI and again in the brief summary is reduced attention by recipients over time. We tested two levels of the ISI (short versus long) and the presence of the Brief Summary (absent versus present) in two different medical conditions (overactive bladder and rheumatoid arthritis). Participants spent more time viewing ads with a long ISI or a brief summary and in some instances, recalled more risks. The combination of a long ISI and a brief summary did not increase or decrease attention to or retention of risk information. Results suggest a long ISI and a brief summary may perform similar functions.
Interactive advertising encourages consumers to interact with the ad instead of passively viewing the ad. We conducted a scoping systematic literature review to summarize the research related to consumer engagement with interactive advertising and its impact on recall and understanding of product claims and risk disclosures. We found that consumers engage with interactive advertisements, but the evidence is mixed as to whether interactive advertising increases consumer engagement, recall, awareness, and comprehension.
FDA-approved labeling, or prescribing information, is an FDA-approved summary of the information needed to use a prescription drug safely and effectively. The labeling is written for healthcare practitioners. There are two types: Physician Labeling Rule (PLR) format (newer labeling format) and “non-PLR” format labeling (older labeling format). FDA’s Drug Labeling Coordinating Committee identified several topics related to the newer labeling format that would benefit from input from physicians. These topics include the resources physicians use to find information about prescription drugs; physicians’ interpretation of specific language in labeling; and presenting information on risks, drug interactions, and overdosage in labeling. The purpose of these interviews was to conduct qualitative research focusing on physicians’ use of, preferences for, and understanding of FDA-approved labeling. The findings suggest that of the content and formatting items surveyed, physicians had the greatest preference for: (1) uniformly specifying the age group for which the drug is indicated in the INDICATIONS AND USAGE section, even for medical conditions that are highly associated with only one particular age group (e.g., adult patients), and (2) uniformly including administration information in relation to food (e.g., “with or without food”) in the DOSAGE AND ADMINISTRATION section for drugs with oral dosing. The findings also suggest that including a long list of interacting drug examples in the DRUG INTERACTIONS section may be misinterpreted to be a comprehensive list.
Animation has been used in DTC prescription drug promotion to adults (for example, Digger the Dermatophyte in Lamisil ads, and Dot in Zoloft ads). A content analysis of DTC animation usage showed that animation was used in a variety of ways and resulted in higher recall for aspects of the ad. The current research involves the creation of professional quality DTC prescription drug television ads and the conduct of a two-part experimental study to examine issues of animation and personification in DTC advertising. We will examine the effects of different types of animation (live action, full animation, and rotoscoping, a process of animating live action scenes) as well as the particular character that is the focus of the animation (sufferer, disease, or benefit). This research will provide information on whether animation influences the recall and perceptions of risk and benefit information in DTC ads.
- Federal Register Notices: 60-day, 30-day
- Effects of Animation and Rotoscoping In Direct-to-Consumer Rx TV Advertising
Utilization of Adequate Provision in Prescription Drug Broadcast Ads among Low to Non-Internet Users (Completed in 2021)
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.
- Federal Register Notices: 60-day, 30-day
- Utilization of Adequate Provision in Prescription Drug Broadcast Ads among Low- and Non-Internet Users
Disclosures of Descriptive Presentations in Professional Oncology Prescription Drug Promotion (Completed in 2021)
Under the Food, Drug, & Cosmetic Act and implementing regulations, promotional labeling and advertising about prescription drugs are required to be truthful, non-misleading, and to reveal facts material to the presentations made about the product being promoted. As a part of the ongoing evaluation of FDA’s regulations in this area, FDA plans to study the impact of disclosures as they relate to presentations of preliminary or descriptive scientific and clinical data in promotional labeling and advertising. The use of disclosures is one method of communicating information to healthcare professionals about scientific and clinical data, the limitations of that data, and practical utility of that information for use in treatment. These disclosures may influence prescriber comprehension and how and what treatment they prescribe for their patients. These impacts may vary based on the technical nature and content of the language used in the disclosure and the level of clinical training the healthcare professional possesses. The current research will address the question of whether the presence and language of disclosures and the presence or absence of a general statement about clinical utility influences prescriber comprehension, perceptions, and intention to prescribe the advertised product.
- Federal Register Notices: 60-day, 30-day
- Physician Interpretation of Data of Uncertain Clinical Utility in Oncology Prescription Drug Promotion
Healthcare Professional Interviews: Risk Processing for Newly Promoted Prescription Drugs (Completed in 2021)
Healthcare professionals (HCPs) are often incredibly busy. This hectic schedule may restrict the ability or willingness of HCPs to process new information, including risk information included in promotional materials for new prescription drug products.
Through 20 semi-structured interviews, this research sought insights regarding how primary care physicians, specialists, physician assistants, and nurse practitioners process risk information for newly promoted prescription drug products, including consideration for the impact of typical time constraints. These interviews also included an assessment of attention to risk information in a mock promotional piece using eye-tracking technology.
Participants reported that they receive new promotional drug material, ranging from several times a week to several times a month. Typically, the material they see comes from medical journals, conferences, or pharmaceutical company representatives that visit their hospitals or offices. Regarding the amount of time they reported reviewing the material, participants’ responses varied. There was a general consensus that the amount of time spent reviewing the materials depended on the relevance of the drug. Some participants reported that if they are interested in the drug (e.g., if it related to their patient population or a patient had exhausted all other available drug options in the same class with little or no positive outcomes), they might spend 5 to 10 minutes reviewing the material in depth. Alternatively, some reported that if the new drug resembles another drug they are familiar with (e.g., is in the same drug class), they might review it for less time because they are already acquainted with the class. Others reported that regardless of their level of interest, they will spend no more than one or 2 minutes reviewing the material (with some reporting 30 seconds or less).
- OMB generic information collection control number: 0910-0695
In 2002 and 2013, FDA surveyed healthcare professionals (HCPs) about their attitudes toward DTC advertising and its role in their relationships with their patients. The 2013 survey included multiple types of HCPs: primary care physicians and specialists, as well as nurse practitioners and physician assistants. Whereas the focus of both previous FDA surveys was on DTC advertising and promotion, the current study was designed to address issues related to professional prescription drug promotion. The goal was to query a representative sample of HCPs about their opinions of promotional materials and procedures targeted at HCPs, clinical trial design and knowledge, and FDA approval status. We also took this opportunity to ask HCPs briefly about their knowledge of abuse-deterrent formulations for opioid products. We conducted a nationally representative survey of approximately 1,240 physicians (primary care and specialists), nurse practitioners, and physician assistants, drawn from WebMD’s subscriber network. The survey provides insights about how professionally targeted prescription drug promotion might influence health care professionals’ decision-making processes and practices and how information may be communicated more accurately.
- What influences healthcare providers’ prescribing decisions? Results from a national survey.
- Opioid education and prescribing practices: Results from a national survey of healthcare providers.
Research in the late 1980s and 1990s examined the size of superimposed text (supers) in general print and television advertising. They found that larger text size generally resulted in greater comprehension of the information featured in the super. These studies also examined other factors such as the type of super, the complexity of the super, and the number of supers per ad. All of these studies occurred before the advent of common DTC television advertising and other promotion based on new technologies. A more recent study examined the role of supers in DTC television ads in terms of dual modality, looking at the content of the supers but not format issues. The current study applied and extended earlier findings to DTC promotion. Moreover, because new technologies have emerged since the publication of these studies, we examined whether findings from television screens are generalizable when viewed on a tablet, where many people now view their media. Finally, we examined the contrast between the super text and the background on which it is located to determine whether that has a measurable effect on recall of the information in the super and the overall message of the ad.
- Superimposed text size and contrast effects in DTC TV advertising. Which presentation format is best for Rx drug messaging to consumers?
Consumer and Healthcare Professional Identification of and Responses to Deceptive Prescription Drug Advertising (Completed in 2021)
Prescription drug promotion sometimes includes false or misleading (collectively, deceptive) claims, images, or other presentations; for instance, representations that a drug is more effective or less risky than is demonstrated by evidence. A number of empirical studies have examined the occurrence and influence of deceptive promotion, both in regard to prescription drugs and other products. No research to our knowledge, however, has investigated the ability of consumers and healthcare providers (HCPs) to independently identify and discount deceptive prescription drug promotion. The ability of consumers and HCPs to identify deceptive prescription drug promotion has important public health implications. If unable to identify deceptive promotion, consumers may ask their HCPs to prescribe specific drugs that they would not otherwise request. Likewise, HCPs who are unable to identify deceptive promotion may prescribe specific drugs that they would not otherwise prescribe. On the other hand, if consumers and HCPs are able to identify deceptive promotion, they may appropriately discount or disregard such information in their medication decisions, and perhaps even report deceptive advertising to appropriate government regulators who can take corrective action.
This project examined the ability of consumers and HCPs to identify deceptive prescription drug promotion, and the influence of such promotion on their attitudes and intentions toward the promoted drug. Additionally, analyses drew comparisons between consumers and HCPs on these outcomes to generate insight about differential effects.
- Federal Register Notices: 60-day, 30-day
- Misinformation and Mass Audiences
- Detecting and Reporting Deceptive Prescription Drug Promotion: Differences across Consumer and Physician Audiences and by Number and Type of Deceptive Claims and Tactics
- Experimental Evidence of Consumer and Physician Detection and Rejection of Misleading Prescription Drug Website Content
- An Empirical Procedure to Evaluate Misinformation Rejection and Deception in Mediated Communication Contexts
Assessing the Inclusion of Foil Items in a Scale to Measure Recognition of Health Messages (Completed in 2020)
The OPDP Research Team often measures participants’ recognition of the messages in prescription drug promotion. Little research exists to guide the construction of these recognition scales. In this study, we analyzed previously-collected data to provide insight into how to construct these recognition scales. The results suggest that creating a recognition scale by summing only the true items in a list of true and false items creates a more discriminant scale than summing both true and false items.
Oncology clinical trials use a variety of clinical endpoints, such as overall survival and progression-free survival. Patients’ understanding of the differences between clinical endpoints is important because misperceptions of treatment efficacy may affect treatment decisions. We first conducted a literature review to find and synthesize available empirical publications assessing patients’ understanding of common oncology clinical endpoints. We searched the literature for empirical research studies focused on (1) clinical endpoints, (2) oncology, and (3) patient understanding. Thirteen publications met the inclusion criteria. These few publications suggest that healthcare professionals and cancer patients generally do not discuss clinical endpoint concepts and that patients can be confused about the purpose of a treatment based on misperceptions about endpoints.
Next, we conducted an environmental scan to find websites accessible by a general audience that defined three clinical endpoints: overall survival, progression-free survival, and response rate. We found several online resources defining each endpoint; however, many of the definitions we identified used technical language that may not be easily understood by patients and caregivers.
Finally, we conducted a series of eight focus groups across the US with cancer survivors (N = 36) and general population adults (N = 36). Few focus group participants were familiar with the technical terms for these endpoints (overall survival, progression-free survival, and response rate). When presented with the endpoint terms and definitions, participants had misconceptions about treatment efficacy. Specifically, they tended to expect that all endpoints were a variation on living longer. The results point to the need for more patient-friendly definitions of clinical endpoints developed with general public and cancer patients’ input.
- Patients’ Understanding of Oncology Clinical Endpoints: A Literature Review
- Patients’ Understanding of Oncology Clinical Endpoints: Environmental Scan and Focus Groups
To gauge how product risks and benefits are communicated in promotional materials, OPDP’s research team uses measures designed to assess both recall/comprehension and perceptions of product risks and benefits. As OPDP’s research program has matured, the way in which we measure risk and benefit perception has evolved over time. This has resulted in perception measures that, while internally valid, tend to vary by study.
In a multi-phase study, we tested and identified 21 validated measures that represent 11 distinct risk/benefit constructs. The final measures demonstrated face validity, convergent validity, criterion-related validity, and scale reliability in both illness and general population samples, among patients with both symptomatic and asymptomatic health conditions, and in response to both television and print direct-to-consumer prescription drug advertisements. Researchers and practitioners can use these items to assess patient perceptions of prescription drug risk, benefit, and efficacy and to ensure greater future comparability between studies.
- Development and validation of prescription drug risk, efficacy, and benefit perception measures in the context of direct-to-consumer prescription drug advertising
A previous FDA study found that simple quantitative information could be conveyed in DTC television ads in ways that increased consumer’s knowledge about the drug (see “Presentation of Quantitative Benefit Information in DTC Television and Print Advertisements for Prescription Drugs” below). However, this research only tested simple information (e.g., one clinical trial, comparison to placebo). Drug information can be much more complicated (e.g., complicated endpoints, multiple study arms). The studies in this project were designed to address the question of whether consumers can take more complicated information into account when assessing prescription drug information in television DTC ads. These studies build on previous research by (1) examining more complicated quantitative information, (2) examining quantitative information for both benefits and risks, and (3) examining how visuals designed to represent efficacy interact with quantitative information.
The first published article from this project suggests that there are tradeoffs to adding multiple quantitative benefit outcomes in DTC ads. However, presenting multiple quantitative risk categories helps consumers better understand a drug’s risks. Specifically, compared with an ad containing no quantitative information, presenting two benefit outcomes and multiple risk categories increased gist and verbatim recall and affected drug perceptions. Compared with presenting a single benefit outcome, presenting two benefit outcomes increased verbatim recall for the second outcome but decreased verbatim recall for the first outcome. Likewise, compared with presenting a single risk category, presenting multiple risk categories increased gist and verbatim recall for the multiple risk categories but decreased gist recall for a concept more closely associated with the single risk category. Adding multiple risk categories decreased risk perceptions even more than did the single risk category.
The second published article from this project suggests that exaggerating benefits visually can mislead viewers. In two studies, we found that participants who saw exaggerated images were more likely than those who saw no image or accurate images to overestimate efficacy. Presenting quantitative information increased participants’ gist and verbatim recall of drug efficacy, and in some cases, led participants to have more accurate perceptions of the drug’s efficacy even in the presence of exaggerated images.
- The Effect of Including Quantitative Information on Multiple Endpoints in Direct-to-Consumer Prescription Drug Television Advertisements
- Visual Images of Prescription Drug Benefits in Direct-to-Consumer Television Advertisements
FDA last surveyed patients about their attitudes toward DTC advertising in 2002 (Aikin, Swasy & Braman, 2004). Results from the 1999 and 2002 patient surveys on this topic indicate a number of areas for follow-up including 1) the percentage of patients who are likely to receive a prescription when they ask for a specific brand, 2) the influence of DTC ads in prompting further information search about the product or the medical condition, 3) patients’ perceptions about the amount of information about the products’ risks versus benefits, and 4) patients’ perceptions that the ads sometimes make the products seem better than they really are.
The purpose of this project is to conduct a follow-up survey to the FDA’s 1999 and 2002 patient surveys on attitudes toward direct-to-consumer promotion of prescription drugs and the impact of such promotion on the doctor-patient relationship. Specifically, we: 1) recruited a wider range of respondents, 2) weighted the data to obtain a nationally representative sample, and 3) asked a wider range of questions about DTC promotion, including questions about online DTC promotion.
The first published article from this survey evaluated US adults’ knowledge of FDA regulation of prescription drug approval and advertising. The results highlight gaps in consumer knowledge of FDA’s roles and responsibilities. For instance, few respondents understood FDA oversight of prescription drug advertising, with approximately half of respondents reporting that they did not know whether FDA approved these ads or components of the ads, and several mis-reporting that FDA approves these ads (31%) or components of the ads (22-41%).
The second published article from this survey explored how patients view the effects of DTC prescription drug advertising on patient-provider interactions. The results suggest that DTC advertising is driving some patients to discuss specific products with their healthcare providers, but that most patients do not believe advertising has a negative influence on the patient-provider interaction itself.
The third published article from this survey gathered updated insights on consumer experiences with and attitudes towards DTC promotion of prescription drugs. Results showed high exposure and indifferent attitudes to DTC promotion. Respondents reported DTC promotion has prompted action, particularly searches for more information, increased use of online resources, and some reported that they refused to take or stopped taking a prescription drug because they saw or heard about the drug’s side effects.
- Consumer Understanding of the Scope of FDA’s Prescription Drug Regulatory Oversight: A Nationally Representative Survey
- Direct-to-Consumer Prescription Drug Advertising and Patient-Provider Interactions
- Consumers’ Experience with and Attitudes toward Direct-to-Consumer Prescription Drug Promotion: A Nationally Representative Survey
Direct-to-Consumer Advertising and the Patient-Prescriber Encounter: A Systematic Review (Completed in 2019)
We systematically reviewed the research on patients’ and prescribers’ perceptions of, and self-reported behaviors prompted by, exposure to direct-to-consumer advertising (DTCA) of prescription drugs that occurs in the context of a clinical encounter. We identified 38 studies that met our criteria, 24 of which used patient-reported outcomes and 18 used prescriber-reported outcomes (four used both). Results suggested some potential benefits of exposure to DTCA, including patients’ enhanced information-seeking, increased patient requests for appropriate prescriptions (when addressing potential underuse) and patients’ perceptions of higher-quality interactions with prescribers. Most prescribers perceived a neutral influence on the quality of their clinical interactions with patients regarding DTCA. Harms included patients receiving prescriptions for drugs that were not appropriate for them or that the patients did not need, and the potential for DTCA to interfere with medication adherence in some populations, such as those with mental illness.
- Direct-to-Consumer Advertising of Prescription Drugs and the Patient–Prescriber Encounter: A Systematic Review
Product attributes (“cues”) can be thought of as intrinsic and extrinsic. Intrinsic cues are physical characteristics of the product (e.g., size, shape) whereas extrinsic cues are product-related but not part of the product (e.g., price and brand name). Research has found that both intrinsic and extrinsic cues can influence perceptions of product quality. Consumers may rely on product cues in the absence of explicit quality information. The objective quality of prescription drugs is not easily obtained from promotional claims in DTC ads; thus consumers may rely upon extrinsic cues to inform their decisions. Market claims such as “#1 Prescribed” and “New” may act as extrinsic cues about the product’s quality, independent of the product’s intrinsic characteristics. Prior research has found that market leadership claims can affect consumer beliefs about product efficacy, as well as their beliefs about doctors’ judgments about product efficacy. One limitation of these prior studies is the lack of quantitative information about product efficacy in the information provided to respondents. Efficacy information may moderate the effect of the extrinsic cue by providing insight into characteristics that would otherwise be unknown. Other research has shown that consumers are able to use information about efficacy to inform judgments about the product. This project examined 1) the effect of two market claims (New, #1 Prescribed) in the context of a DTC print ad with and without product efficacy information, and 2) the tradeoff between a market claim of #1 Prescribed and quantitative efficacy information.
Results of the first part of the project (experimental study) suggest the market claim affects personal perceptions and perceptions of the ad’s message about drug benefits and perceptions about doctors’ opinions of the drug. Inclusion of quantitative information about product efficacy did not show a large influence on perceptions.
In the second part of the project (tradeoff analysis), 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.
- Market Claims and Efficacy Information in Direct-to-Consumer Prescription Drug Print Advertisements
- Consumer Tradeoff of Advertising Claim Versus Efficacy Information in Direct-to-Consumer Prescription Drug Ads
Impact of Ad Exposure Frequency on Perception and Mental Processing of Risk and Benefit Information in DTC Prescription Drug Ads (Completed in 2018)
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. 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. 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. Effects on memory were small; retention of both risks and benefits remained low overall even after four exposures.
- Taking Repeated Exposure into Account: An Experimental Study of Direct-to-Consumer Prescription Drug Television Ad Effects
Because older adults use a disproportionate number of prescription drugs and watch more television than other age groups, their understanding of DTC television advertising is important to investigate. Age-related changes in hearing are nearly universal and may influence the understanding of speech and therefore the understanding of DTC television ads. This study explored how hearing and cognitive declines across the lifespan affect comprehension of DTC television ads in general and of the major statement of risks in particular. Results showed that cognitive changes and age were driving factors in the recall of risks in DTC television ads. The study also showed that the speed of the spoken major statement and the complexity of the spoken major statement, but not the audio frequency of the voiceover, had negative effects on recall.
- Assessing Hearing and Cognition Challenges in Consumer Processing of Televised Risk Information: Validation of Self-reported Measures using Performance Indicators
- Aging and Direct-to-Consumer Prescription Drug Television Ads: The Effects of Individual Differences and Risk Presentation
Content Analysis of Accelerated Approval Prescription Drug Direct-to-Consumer Websites (Completed in 2018)
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. From the 34 brand-name prescription drugs under the Food and Drug Administration’s accelerated approval pathway presubmission requirement for promotional materials in December 2016, we identified a sample of 26 that had active DTC websites. Two raters independently coded the websites for the presence, placement, content, and readability of an accelerated approval disclosure. Most (73%) of the websites contained an accelerated approval disclosure. Most of the disclosures (84%) included the basis for accelerated approval, whereas 68% stated that the clinical benefit of the product was unknown and 47% conveyed the need for additional research to confirm study findings. On average, the disclosures required at least a high school reading level and most conveyed the information in medical terms.
Several studies show that physicians are influenced by the way clinical trial results are reported. This may be a function of physicians’ knowledge about clinical trial design, or their experience with and skill in interpreting statistics. Surveys find that physicians believe knowledge of biostatistics is important but have less knowledge than is needed to understand all clinical trial results. However, little is known about physicians’ reactions to and understanding of clinical trial data presented in professional prescription drug promotion. We conducted 60-minute interviews with practicing physicians across the United States (50 primary care physicians and 22 endocrinologists). Physicians viewed prescription drug promotional materials that contained clinical trial data and answered follow-up questions. Physicians demonstrated low to moderate knowledge about clinical trial-related terms found in promotional prescription drug materials. Results from this qualitative analysis underscore a need to determine how clinical trial data in prescription drug promotional materials affect physicians' attitudes and decision making.
This is a descriptive content analysis of major statements of risk information in DTC television ads. We examined characteristics of these risk presentations, including speed of presentation, complexity of the language, and the voice frequency of the statement. Major statements often presented numerous risks, usually in order of severity, with no quantitative information about the risks’ severity or prevalence. The major statements required a high school reading level, and many included long and complex sentences. The major statements were often accompanied by competing non-risk information in the visual images, presented with moderately fast-paced music, and read at a faster pace than benefit information. Overall, we discovered several ways in which the communication of risk information could be improved.
- Communicating Risk Information in Direct-to-Consumer Prescription Drug Television Ads: A Content Analysis
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, which may result in reduced consumer comprehension, minimization of important risk information and, potentially, therapeutic non-compliance due to fear of side effects. Others argue that they leave out important information. We examined the impact of the 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 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. 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. 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. 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.
- Serious and Actionable Risks, Plus Disclosure: Investigating an Alternative Approach for Presenting Risk Information in Prescription Drug Television Advertisements
- Individual- and Ad-Level Predictors of Perceptions of Serious and Actionable Risks in Direct-to-Consumer Prescription Drug TV Advertising
Comparative Price Information in DTC and Professional Prescription Drug Advertisements (Completed in 2017)
By their very nature, medical and health decisions are comparative (e.g., treatment versus no treatment). For consumers, these decisions may include whether to use prescription drug products, over-the-counter products, or herbal supplements. Sponsors of prescription drug advertisements may decide to include truthful, non-misleading information about the price of their products in promotion. This may extend to price comparison information, wherein sponsors may include information about the price of a competing product, provided certain conditions are met. These advertisements may not, either directly or by implication, represent that the drug is safer or more effective than another drug unless substantiated by appropriate evidence. We investigated, through empirical research, the impact of price comparison information about the reference and comparator product and additional contextual information about the comparative safety and efficacy of the productson prescription drug product perceptions. This was investigated in DTC and healthcare-directed professional advertising for prescription drugs.
For the HCP-directed component of the study, we found that the majority of physicians accurately recognized the price claim (76%) 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.
Results for the DTC ad portion of the study indicated that when people remembered seeing the disclosure, they demonstrated uncertainty regarding risks, efficacy, and savings; however, most did not notice the disclosure, despite its prominent placement in the ad.
- Physician Response to Contextualized Price-Comparison Claims in Prescription Drug Advertising
- Consumer Reactions to Price Comparison and Disclosure Information in Prescription Drug Print Advertising
Prescribers’ Knowledge and Skills for Interpreting Research Results: A Systematic Review (Completed in 2017)
The objective of this review was to synthesize the research related to prescribers' critical appraisal knowledge and skills about understanding of statistical methods, biases in studies, and relevance and validity of evidence. We screened 1204 abstracts, 72 full-text articles, and included 29 studies. Results indicated that physicians' extant knowledge and skills were in the low to middle of the possible score ranges and demonstrated modest increases in response to interventions. Physicians with formal education in epidemiology, biostatistics, and research design demonstrated higher levels of knowledge and skills. In hypothetical scenarios presenting equivalent effect sizes, the use of relative effect measures was associated with greater perceptions of medication effectiveness and intent to prescribe, compared with the use of absolute effect measures, but this evidence was limited by use of convenience samples and study designs that limit internal validity. Critical appraisal knowledge and skills are limited among physicians. The effect measure used can influence perceptions of treatment effectiveness and intent to prescribe.
This project included descriptive content analyses of two forms of online DTC prescription drug promotion. The first content analysis focused on whether and how branded prescription drug promotion delivered on mobile technology (phones, tablets) present drug benefit and risk information. We analyzed a sample of 51 mobile promotional communications and their associated linked landing pages. We assessed the content and format of the mobile communications and landing pages with regard to presentation of drug benefits and risks. These results indicate that, while risks and benefits are both represented in mobile communications and their associated landing pages, they are not equally prominent and accessible.
The second content analysis focused on whether and how cancer-related branded prescription drug websites present quantitative information about drug benefits and risks. We analyzed a sample of 65 active cancer-related prescription drug websites. We assessed the inclusion and presentation of quantitative information for two audiences (consumers and healthcare professionals) and two types of information (drug benefits and risks). We found that consumers and healthcare professionals have access to quantitative information about oncology drugs and, in particular, about the benefits of these drugs.
- Direct-to-Consumer Promotion of Prescription Drugs on Mobile Devices: A Content Analysis
- Quantitative Information on Oncology Prescription Drug Websites
Eye Tracking Study of Direct-to-Consumer Prescription Drug Advertisement Viewing (Completed in 2016)
Current FDA regulations require that a major statement of the risks of prescription drugs be included in at least the audio of DTC television ads. FDA has introduced the idea of including the risk information in DTC television ads in superimposed text as well as in the audio (75 FR 15376, “Direct-to-Consumer Prescription Drug Advertisements; Presentation of the Major Statement in Television and Radio Advertisements in a Clear, Conspicuous, and Neutral Manner”). In addition, the Food and Drug Administration Amendments Act of 2007 (FDAAA) required a study to determine if the statement “You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088” (the MedWatch statement) is appropriate for inclusion in DTC television ads. These communications have been tested separately by FDA; however, they have not been examined together. In addition, potentially distracting images and sounds during the major statement of risks in DTC television ads continue to be a topic of interest. Previous research has shown that factors such as multiple scene changes and music in advertising can be distracting. However, the effects of this kind of distraction during the major statement of risks on consumers' perceptions and risk recall has not been tested in the presence of risk-reinforcing superimposed text.
This project used eye tracking technology to determine how these communications in DTC ads were perceived, as well as to measure the impact of distraction. Eye tracking technology is an effective method to determine the extent to which consumers attend to risk information presented in DTC television ads. This technology allows researchers to unobtrusively detect and measure where, and for how long, a participant looks while viewing a television ad. We found that distracting elements during the major statement decreased attention to the superimposed risk text, which led to lower retention of the drug risk information. This suggests that even if the risk information is presented in audio and in superimposed text, distracting visuals should still be avoided.
- Attention to and Distraction from Risk Information in Prescription Drug Advertising: An Eye Tracking Study
This project was designed to test different ways of presenting prescription drug risk and benefit information on branded drug websites. One study explored the role of risk information placement and format. We found that the location of risk information on prescription drug websites affected consumers’ risk knowledge, suggesting that risk information is more effective when located on the homepage. We found no significant effects for including a signal to the risk information or for different formatting of the risk information (e.g., paragraphs versus bulleted lists).
In another study, we explored consumers’ understanding of drug information when a branded prescription drug website included a link to disease information. We found that consumers who saw a prescription drug website with a link to a disease information website confused drug benefits and disease information, even when disclosures explained that the disease information website was external. In an analysis of data across studies, we found that some consumers interpreted precautions on prescription drug websites as potential side effects.
Another study examined how videos on prescription drug websites, and the inclusion of risk information in those videos, influence consumer knowledge and perceptions. The results suggest that including risks in branded drug website videos may increase in-video risk retention at the expense of text-only risk retention. We also found that using an actor to communicate prescription drug risks on pharmaceutical websites does not appear to improve consumers’ understanding of prescription drug information.
We also conducted focus groups as part of this project. One issue explored in these focus groups was the role of online health communities in patient-provider discussions. Our analysis showed that individuals use online health communities to obtain more information about their health in addition to their communication with, and reliance on, their healthcare providers.
- Testimonials and Informational Videos on Branded Prescription Drug Websites
- Actors in Whitespace: Communicating Risk Information on Pharmaceutical Websites
- Placement and Format of Risk Information on Direct-to-Consumer Prescription Drug Websites
- Are Disease Awareness Links on Prescription Drug Websites Misleading? A Randomized Study
- Consumer Confusion Between Prescription Drug Precautions and Side Effects
- Peer-generated Health Information: The Role of Online Communities in Patient and Caregiver Health Decisions
- Perceived Healthcare Provider Reactions to Patient and Caregiver Use of Online Health Communities
Effect of Promotional Offers on Consumer Perceptions of Product Risks and Benefits (Completed in 2016)
Research shows that consumers rate a product more favorably when they own it or are simply given a gift certificate or a coupon for that product or service. The inclusion of a coupon or other price incentive in the body of a DTC ad may affect consumers' perceptions of the risks and benefits of the prescription drug. For instance, consumers may assign more weight to benefit claims in cases where a coupon or other price incentive is embedded in the advertisement. For "simple" consumer products, coupons and free trial offers may enable the customer to test new products while minimizing his or her financial risk of testing the product. For products that consumers can readily test and ones where performance can be adequately verified, coupons and free trial offers provide both the consumer and manufacturer an efficient mechanism for matching consumers and products. For more complex products such as prescription drugs where supervision of a physician is required to evaluate both appropriateness and performance, coupons and free trial offers may send different signals.
This study examined what impact, if any, the presence of coupons in DTC advertisements have on consumers' recall and perceptions of product risks and benefits, and the overall impression of the product in DTC full-product and reminder advertisements. 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.
- Consumer Perceptions of Prescription and Over-the-Counter Drug Advertisements with Promotional Offers
The volume of prescription drug promotion over time is often measured by assessing changes in promotional spending. However, this method obscures the fact that some types of promotion are more expensive than others. Another way to measure the changes in prescription drug promotion over time is to assess the number of promotional pieces submitted to the U.S. Food and Drug Administration (FDA). Form FDA 2253 collects information such as the date submitted and the type of material submitted. We analyzed data from Forms FDA 2253 received from 2001–2014. We examined the frequency of submissions by audience (consumer and healthcare professional) and type of promotional material. There was a noted increase in prescription drug promotion submissions across all media in the early 2000s. Although non-Internet promotion submissions have since plateaued, Internet promotion continued to increase. These results can help public health advocates and regulators focus attention and resources.
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.
We found 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.
To market their products, manufacturers of prescription drugs must demonstrate efficacy and safety to FDA, typically in two adequate and well-controlled clinical trials. In some cases, product efficacy can be measured by a single endpoint, such as high blood pressure. In other cases, however, efficacy is measured by multiple endpoints or outcomes that are sometimes combined into an overall score called a composite score. For example, nasal congestion is measured by examining individual symptoms such as runny nose, itchiness, and sneezing. Each symptom is measured on its own. An overall score is computed from the individual symptom measurements and if the drug has a significantly better overall score than the comparison group (e.g., placebo), the drug may gain approval and be marketed for nasal congestion. The drug may be significantly better overall but not be significantly better on a particular aspect (e.g., runny nose), however. Scientists and medical professionals have had training to understand the difference between composite score endpoints and individual endpoints but the general public has not. Given the frequency of DTC advertising, it is important to determine whether consumers grasp composite scores as they are currently communicated and how best to communicate such scores to lay audiences in general. This study found that participants were not familiar with the concept of composite scores but that informing them about composite scores increased their understanding of them and influenced perceptions of the advertised products.
- Consumers’ Understanding of FDA Approval Requirements and Composite Scores in Direct-to-Consumer Prescription Drug Print Ads
- Communicating Efficacy Information Based on Composite Scores in Direct-to-Consumer Prescription Drug Advertising
Do Prescription Drug Ads Tell Consumers Enough About Benefits and Side Effects? Results from the Health Information National Trends Survey, Fourth Administration. (Completed in 2015)
The U.S. Food and Drug Administration (FDA) analyzed data collected by the National Cancer Institute to determine whether average American consumers believe direct-to-consumer advertisements (DTCA) include enough information about the risks and benefits of prescription drugs.
In this survey, 52% of respondents reported that DTCA does not have enough information about risks and 46% of respondents reported that DTCA does not have enough information about benefits. When we looked at these two questions together, we found that a large group of respondents, 41%, reported that DTCA does not have enough information about both risks and benefits.
- Do Prescription Drug Ads Tell Consumers Enough About Benefits and Side Effects? Results From the Health Information National Trends Survey, Fourth Administration
Experimental Study of Format Variations in the Brief Summary of DTC Print Advertisements (Completed in 2015)
There have been calls to create a “drug facts box” for prescription drug ads similar to the one currently used for OTC drug labels. However, it is unclear which data—whether numeric, qualitative, or a combination of the two—best aids consumer understanding. The statement “50 out of 100 people reported less pain” is an example of numeric data whereas “more people had pain relief” is an example of qualitative data. For this study, we tested combinations of numeric and qualitative data to find out what information may be most useful in a drug facts box. Our study demonstrates that the majority of participants who viewed numeric data were able to accurately report it. When people were provided with absolute frequencies and percentages, they were able to use this numeric data to report benefit and risk information regardless of whether they also saw absolute differences or qualitative information. These findings suggest that a simpler drug facts box may be useful for people trying to make decisions about prescription drugs.
- Communicating Benefit and Risk Information in Direct-to-Consumer Print Advertisements: A Randomized Study
FDA regulations require prescription drug ads to contain accurate information about the benefits and risks of the drug advertised. When this is not the case, corrective advertising can be used to dissipate or correct erroneous beliefs resulting from a false claim. In 2009, for example, Bayer HealthCare Pharmaceuticals produced and aired corrective advertising for Yaz, a birth control pill, following a warning from FDA regarding misleading claims. Despite these developments, there is little experimental evidence about the influences of DTC corrective ads on prescription drug consumers. The current project examined the influence of corrective messages in the realm of consumer-directed prescription drug advertising. Specifically, the project examined the following variables of interest: (1) exposure to corrective advertising, (2) visual similarity between the original and corrective ads, and (3) time delay between the original and corrective ads. Regarding exposure to corrective advertising, we found that a corrective ad counteracted beliefs of an overstatement of efficacy claim, but was less successful in counteracting omission of risk. Corrective ad exposure also affected perceptions of, and intended behaviors toward, the drug. Examining the effect of similarity and time delay suggests corrective ad exposure can influence consumer perceptions of drug efficacy, risks, and benefits previously established by violative ads. Corrective ads also can weaken consumer intentions to consider and seek more information about a drug. However, ad similarity does not appear to affect consumer perceptions and preferences. The length of the delay between violative and corrective ad exposure has limited influence. Broadly, these results offer evidence in support of the contention that television advertising explicitly designed to correct viewer beliefs about the risks and benefits of a prescription drug can be successful, and while further research is needed, these findings suggest that corrective advertising appears to be a viable remedy to combat some forms of misinformation through advertising.
- Correction of Overstatement and Omission in Direct-to-Consumer Prescription Drug Advertising
- Correction of Misleading Information in Prescription Drug Television Advertising: The Roles of Advertisement Similarity and Time Delay
FDA surveyed physicians about their attitudes toward DTC advertising and its role in their relationships with their patients in 2002. Almost 10 years later, FDA questioned physicians again, both to get an updated sense of physician attitudes and to extend the 2002 survey. Specifically, FDA (1) recruited a wider range of prescribers, including nurse practitioners and physician assistants; (2) weighted the data to obtain a representative sample of healthcare professionals; and (3) asked a wider range of questions, both about DTC and professional promotion of prescription drugs. The study also examined awareness of FDA’s Bad Ad program and healthcare professionals’ use of social media.
- Awareness of the Food and Drug Administration’s Bad Ad Program and Education Regarding Pharmaceutical Advertising
- Professional Online Community Membership and Participation among Healthcare Providers: An Extension to Nurse Practitioners and Physician Assistants
As part of the requirements of the Food and Drug Administration Amendments Act of 2007 (FDAAA), we examined the addition of a statement in DTC television ads directing individuals to a phone number and website to which they can report side effects. We investigated the role of placement, duration, and prominence in the understanding of the product risk and benefit information in the ad, and the comprehension of the toll-free statement itself. We found that presenting the statement in both text and audio resulted in better processing of the statement than text-only presentations. When the statement was shown in text alone, presenting it during the entire advertisement or after the statement of risks resulted in better processing than a placement before the risk information. The placement, duration, and prominence of the statement did not affect risk or benefit comprehension. Further, 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.
- An Empirical Examination of the FDAAA-Mandated “Toll-Free Statement” for Consumer Reporting of Side Effects in Direct-to-Consumer Television Advertisements
- 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
Spousal Influence on Consumer Understanding of, and Response to, DTC Prescription Drug Advertisements (Completed in 2015)
In 2013, OPDP developed research to provide fuller understanding about the social context in which DTC ads are often viewed. Some components of this research were completed, whereas others were withdrawn due to concerns about their practical utility. Completed portions of the research examined experiences related to chronic illness management and medication decision-making among asthma patients and partners of asthma patients. That research showed that partners were involved in a variety of roles in asthma management and medication decision-making. Discussion triggers included worsening of symptoms, doctor visits, and medication cost and insurance coverage. Most partners are moderately or actively involved in the patient experiences of managing asthma, and this involvement is generally beneficial to the patient.
FDA’s proposed rule, "Direct-to-Consumer Prescription Drug Advertisements; Presentation of the Major Statement in Television and Radio Advertisements in a Clear, Conspicuous, and Neutral Manner" (75 FR 15376), proposes including the risk information in prescription drug television ads in both superimposed text and in the audio. In addition, FDAAA required a study to determine if the statement “You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088” (the MedWatch statement) is appropriate for inclusion in DTC television advertisements for prescription drug products. These communications have been tested separately by FDA; however, they have not been examined together. In addition, questions continue to arise about the use of potentially distracting images during the major statement of risks in the television ads. This project was designed to create and pretest stimuli that will include these additional elements (superimposed risk information and the MedWatch statement) and vary the degree of distraction during the major statement. The stimuli created for this project is being used in an experimental study—described under “Eye Tracking Study of Direct-to-Consumer Prescription Drug Advertisement Viewing”—that will use eye-tracking methodology.
Focus groups allow FDA to investigate areas of interest to OPDP and sharpen the focus of the research questions for later quantitative studies. For this particular set of focus groups, we examined consumer and healthcare provider associations with the terms “natural” and “targeted,” and obtained reactions to prescription drug promotion that use these terms. Both consumers and healthcare professionals were generally skeptical about claims using the term “natural,” in particular when the term was associated with prescription drug promotion. They did not expect that prescription drugs, which must be approved by the FDA and are developed by pharmaceutical companies, would be pure and free of all additives. In the context of the particular ads and examples given, most consumers and healthcare providers thought that the use of the term “targeted” was appropriate for certain prescription drugs. Select differences between healthcare providers and consumers were also observed. For example, providers seemed more willing than consumers to accept the use of the term “natural” for products with less than 100% natural ingredients. While these results do not provide conclusions regarding the acceptability of these terms in advertising or promotional labeling for individual prescription drugs, they do provide valuable information about consumer and healthcare provider perceptions that will be useful for consideration in future research.
Despite extensive research on comparative advertising of consumer products in general and a limited number of studies on how DTC ads could help consumers compare drugs, very little research has been conducted on comparative prescription drug advertisements. Currently, most DTC ad comparisons focus on drug attributes, such as differences in dosing or administration method. Because few head-to-head clinical trials have been conducted, very few DTC ads include efficacy-based comparisons. This study explored two types of drug comparisons in DTC print and television ads: (1) drug efficacy comparisons; and (2) other evidence-based comparisons: dosing, mechanism of action, and indication.
The first experiment showed that participants who viewed print (but not video) ads with named competitors had greater efficacy and lower risk perceptions than participants who viewed unnamed competitor and noncomparative ads. In the second experiment, named competitors in print ads resulted in higher risk perceptions than unnamed competitors. In video ads, participants who saw an indication comparison had greater benefit recall than participants who saw dosing or mechanism of action comparisons. In addition, visual depictions of the comparison decreased risk recall for video ads. Overall, the results suggest that comparative claims in DTC ads could mislead consumers about a drug’s efficacy and risk; therefore, caution should be used when presenting comparative claims in DTC ads.
- Effects of Comparative Claims in Prescription Drug Direct-to-Consumer Advertising on Consumer Perceptions and Recall
This project contained two studies. The first study involved the main advertising (display) page of DTC print ads. We examined whether adding placebo rate information and whether changing the framing of the information to include only the number who benefit (positive frame) versus the number who benefit and the number who do not benefit from the drug (mixed frame) helps consumers understand the risk information. Results showed that adding placebo rates to DTC ads may be useful for consumers, whereas the evidence does not support the use of mixed frames.
The second study explored how physicians use the approved label (prescribing information or PI), and specifically how they assess efficacy information in this document. We found that physicians review the sections in order, looking most frequently at “Warnings and Precautions” and “Dosage and Administration.” Viewing certain PI sections was associated with greater perceived risk, lower perceived benefits, and lower intention to prescribe. The results suggest that the content and format changes to the PI in 2006 are effective and that information in the PI is relevant to physician decision-making.
- Randomized Study of Placebo and Framing Information in Direct-to-Consumer Print Advertisements for Prescription Drugs
- Primary Care Physicians’ Use of FDA-Approved Prescription Drug Labels
- Important Safety Information or Important Risk Information? A Question of Framing in Prescription Drug Advertisements
- Presenting Quantitative Information About Placebo Rates to Patients
To make informed decisions about healthcare and to use their medications correctly, consumers need easy access to up-to-date and accurate information about the risks, benefits, and safe use of their prescription drugs. Consumers currently receive multiple pieces of paper with their prescription drugs from the pharmacy, containing information that is developed and distributed through various sources. Written prescription drug information is provided through a voluntary effort (Consumer Medication Information) as well as through FDA-mandated use of Medication Guides and Patient Package Inserts (PPI). We found that patients describe a wide range of experiences and varying degrees of satisfaction with information currently provided at the time medicines are received at the pharmacy. In some cases, the written documents are difficult to read and understand, duplicative and overlapping, and incomplete or contradictory. This project was designed to test different ways of presenting information about prescription drugs to patients who have obtained a prescription.
- Preferences for Patient Medication Information: What Do Patients Want?
- Influence of Patient Medication Information Format on Comprehension and Application of Medication Information: A Randomized, Controlled Experiment
Presentation of Quantitative Benefit Information in DTC Television and Print Advertisements for Prescription Drugs (Completed in 2012)
We assessed whether quantitative information could be successfully added to television and print advertisements to maximize audience understanding of benefit information in the piece. We investigated the level of product efficacy (high or low), the statistical format of that information (frequency, percent, frequency plus percent, relative frequency, or frequency plus relative frequency), and ways in which that information can be expressed visually (pie chart, bar chart, table, or pictograph). In general, we found that providing quantitative benefit information in DTC ads increased participants’ ability to accurately report the benefits of the drug in quantitative terms. Further, adding visual aids, in particular bar charts and tables, increased participants’ ability to accurately report the drug’s benefits.
- Presenting Efficacy Information in Direct-to-Consumer Prescription Drug Advertisements
- Visual presentations of Efficacy Data in Direct-to-Consumer Prescription Drug Print and Television Advertisements: A Randomized Study
Quantitative Summary of the Benefits and Risks of Prescription Drugs: A Literature Review (Completed in 2011)
A literature review was conducted in response to Section 3507 of the Patient Protection and Affordable Care Act of 2010. The literature review focused on two questions:
- What is the value of quantitative information or summaries about the risks and benefits of medical interventions for consumers, patients, and clinicians?
- How does presentation of quantitative information influence consumers’, patients’, and clinicians’ processing and understanding of the risks and benefits of medical interventions?
The review suggests that quantitative information about risks and benefits of medical interventions may have a positive effect on outcomes such as accurate knowledge. However, the review did not identify a specific presentation (for example, format or graph) that consistently led to better outcomes than other presentations. The review also addressed related issues, such as numeracy and health literacy.
- Communicating Quantitative Risks and Benefits in Promotional Prescription Drug Labeling or Print Advertising
DTC television ads tend to attract much attention because they are so widely disseminated. Critics of DTC ads speculate that visual images of emotionally pleasant scenes during the presentation of risk information detract from the comprehension of that risk information. The current study investigated the role of visual and tonal distraction as well as the potential mitigating role superimposed text may play. Results demonstrated strong evidence that including risk-reinforcing superimposed text during the major statement increases comprehension of that risk information. Findings regarding visual and tonal distraction were less clear, partially due to manipulations that were not as strong as intended.
- Experimental Evaluation of the Impact of Distraction on Consumer Understanding of Risk and Benefit Information in Direct-to-Consumer Prescription Drug Television Advertisements: Executive Summary
- Experimental Evaluation of the Impact of Distraction on Consumer Understanding of Risk and Benefit Information in Direct-to-Consumer Prescription Drug Television Advertisements: Questions and Answers
As part of this study, the OPDP research team conducted a supplementary examination of the same issues using an alternate method. For more information about the supplementary study, please see:
- A Supplementary Test of Distraction in DTC Advertising Using an Implicit Measure, The Affect Misattribution Procedure: Executive Summary
- A Supplementary Test of Distraction in Direct-to-Consumer (DTC) Advertising Using an Implicit Measure, The Affect Misattribution Procedure (AMP): Questions and Answers
To improve understanding of how consumers use the brief summary and explore ways in which it might be improved, we conducted studies to address the following three questions:
- Does the risk information presented on the first page of the ad (the display page) influence the way that people read through and understand the information in the brief summary, and what topics do people think are important in the brief summary?
- Do additional details and context about side effects negatively affect the reading and understanding of other risk information in the brief summary?
- How do alternative formats compare with the commonly used format for the brief summary?
The results of these studies provide important insights into how consumers use information in the brief summary and ways in which the information could be improved. For instance, we found that the addition of a serious risk to the display page and the addition of frequency and duration information about side effects in the brief summary did not negatively affect the understanding of the risk information as a whole, including the most serious warnings and precautions. Thus, the addition of other types of context to the brief summary, such as numerical (quantitative) summaries, can be explored with less concern about overloading readers.
In 2006, the Best Pharmaceuticals for Children Act mandated that a statement be included on packaging for prescription and over-the-counter (OTC) products that gave consumers a contact number for FDA to report serious side effects. OPDP, in coordination with FDA’s Office of Regulatory Policy, conducted a study to determine the best wording for this statement. A series of focus groups with consumers was held which led to the selection of nine possible statements for quantitative testing. Experimental research was then conducted to evaluate these statements. Analyses showed that all statements were generally clear and understandable with the exception of one statement. Participants were able to distinguish between serious and minor side effects and reported that they would call their healthcare provider for medical emergencies rather than FDA. Overall, few individuals reported that they would call the FDA to report side effects.
- Toll-Free Number for Reporting Adverse Events on Labeling for Human Drug Products: Label Comprehension
Patient and Physician Attitudes and Behaviors Associated with DTC Promotion of Prescription Drugs (Completed in 2004)
To evaluate attitudes toward DTC broadcast ads and the impact these ads have on doctor-patient interactions, two surveys of consumers were undertaken in 1999 and 2002. A survey of physicians was also conducted in 2002. Findings indicate that DTC advertising has both positive and negative effects, as reported from both the physician and patient perspective. DTC advertising has potential to increase awareness of conditions and treatments, motivate questions for the healthcare provider, and help patients ask better questions. However, DTC advertising may also lead physicians to feel pressured to prescribe particular drugs. These findings are important because any influence that DTC advertising has on the doctor-patient relationship may have broad implications for healthcare.
- Patient and Physician Attitudes and Behaviors Associated With DTC Promotion of Prescription Drugs - Summary of FDA Survey Research Results