Kathryn J. Aikin

Randomized Trial of Risk Information Formats in Direct-to-Consumer Prescription Drug Advertisements

Background. Federal regulations specify that print advertisements for prescription drugs and biological products must provide a true statement of information “in brief summary” about each advertised product’s “side effects, contraindications, and effectiveness.” Some of the current approaches to fulfilling the brief summary requirement, although adequate from a regulatory perspective, result in ads that may be difficult to read and understand when used in consumer-directed promotion. Objective. To explore ways in which the brief summary might be improved. Design. The authors conducted an experimental study that examined 300 consumers’ (mall visitors ever told that they were overweight) understanding of and preference for 4 different brief summary formats: traditional (a plain-language version of the risk sections from professional labeling), question and answer (Q&A; with headings framed in the form of questions), highlights (a summary section from revised professional labeling), and prescription drug facts box (similar to the current over-the-counter drug facts label). Results. The format had several effects. For instance, participants who viewed the drug facts format were better able to recall risks (P < .01) and reported greater confidence to perform the tasks (P < .01) than those who saw the traditional format. Differences in preference were noted; for example, the drug facts format was ranked highest, followed by the Q&A format, the traditional format, and finally the highlights format, P < 0.001. Conclusions. Taken together, these data suggest that the traditional method of conveying information in the brief summary is neither the most comprehensible nor the most preferred by consumers. These data provide policy makers and researchers with important information regarding the role of format in consumers’ understanding of the brief summary.

Presenting efficacy information in direct-to-consumer prescription drug advertisements

OBJECTIVE We evaluated whether presenting prescription drug efficacy information in direct-to-consumer (DTC) advertising helps individuals accurately report a drugs benefits and, if so, which numerical format is most helpful. METHODS We conducted a randomized, controlled study of individuals diagnosed with high cholesterol (n=2807) who viewed fictitious prescription drug print or television ads containing either no drug efficacy information or efficacy information in one of five numerical formats. We measured drug efficacy recall, drug perceptions and attitudes, behavioral intentions, and drug risk recall. RESULTS Individuals who viewed absolute frequency and/or percentage information more accurately reported drug efficacy than participants who viewed no efficacy information. Participants who viewed relative frequency information generally reported drug efficacy less accurately than participants who viewed other numerical formats. CONCLUSION Adding efficacy information to DTC ads-both in print and on television-may potentially increase an individuals knowledge of a drugs efficacy, which may improve patient-provider communication and promote more informed decisions. PRACTICE IMPLICATIONS Providing quantitative efficacy information in a combination of formats (e.g., absolute frequency and percent) may help patients remember information and make decisions about prescription drugs.

Communicating Benefit and Risk Information in Direct-to-Consumer Print Advertisements A Randomized Study

Background: Previous research demonstrated that providing qualitative and quantitative information in a “drug facts box” may help individuals understand prescription drug information in print-based direct-to-consumer advertisements. The authors sought to determine whether qualitative, quantitative, or a combination thereof best communicates benefit and risk information. Methods: To replicate and extend previous research, the authors used simple quantitative drug information. A randomized controlled study was conducted with 5067 Internet panelists with heartburn. Participants viewed a drug facts box with benefit and risk information that varied the presence or absence of qualitative summaries and absolute frequencies, percentages, and absolute differences. Measures included knowledge of drug benefits and risks, perceptions, and intentions. Results: Providing absolute frequencies and percentages most improved participants’ drug knowledge and affected perceptions and intentions. Conclusions: The study findings suggest that, for simple drug information, adding absolute frequencies and percentages to direct-to-consumer advertisements may benefit consumers. Absolute differences and qualitative labels may not be needed.

Randomized Study of Placebo and Framing Information in Direct-to-Consumer Print Advertisements for Prescription Drugs

BackgroundResearch suggests that quantitative information in direct-to-consumer (DTC) prescription drug ads may be helpful for consumers.PurposeThe objective was to examine the effect of adding placebo rates and framing to DTC ads.MethodsIn study 1, 2,000 Internet panel members with chronic pain participated in a randomized controlled experiment of DTC ads varying in placebo rate and framing. In study 2, 596 physicians ranked DTC ads varying in placebo rate and framing by how well they conveyed scientific information and their usefulness for patients.ResultsIn study 1, participants who viewed placebo rates were able to recall them and use them to form certain perceptions. A mixed frame led to lower placebo rate recall and perceived efficacy. In study 2, overall, physicians preferred a placebo/single frame ad.ConclusionsAdding placebo rates to DTC ads may be useful for consumers. The evidence does not support using a mixed frame.

Visual presentations of efficacy data in direct-to-consumer prescription drug print and television advertisements: A randomized study

OBJECTIVE To determine whether visual aids help people recall quantitative efficacy information in direct-to-consumer (DTC) prescription drug advertisements, and if so, which types of visual aids are most helpful. METHODS Individuals diagnosed with high cholesterol (n=2504) were randomized to view a fictional DTC print or television advertisement with no visual aid or one of four visual aids (pie chart, bar chart, table, or pictograph) depicting drug efficacy. We measured drug efficacy and risk recall, drug perceptions and attitudes, and behavioral intentions. RESULTS For print advertisements, a bar chart or table, compared with no visual aid, elicited more accurate drug efficacy recall. The bar chart was better at this than the pictograph and the table was better than the pie chart. For television advertisements, any visual aid, compared with no visual aid, elicited more accurate drug efficacy recall. The bar chart was better at this than the pictograph or the table. CONCLUSION Visual aids depicting quantitative efficacy information in DTC print and television advertisements increased drug efficacy recall, which may help people make informed decisions about prescription drugs. PRACTICE IMPLICATIONS Adding visual aids to DTC advertising may increase the publics knowledge of how well prescription drugs work.

Despite 2007 Law Requiring FDA Hotline To Be Included In Print Drug Ads, Reporting Of Adverse Events By Consumers Still Low

In 2007 the federal government began requiring drug makers to include in their print direct-to-consumer advertisements information for consumers on how to contact the Food and Drug Administration directly, either by phone or through the agencys website, to report any adverse events that they experienced after taking a prescription drug. Adverse events can range from minor skin problems like itching to serious injuries or illness that result in hospitalization, permanent disability, or even death. Even so, current rates of adverse event reporting are low. We studied adverse event reports about 123 drugs that came from patients before and after the enactment of the print advertising requirement and estimated that requirements impact with model simulations. We found that if monthly spending on print direct-to-consumer advertising increased from zero to

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

7.7 million per drug, the presence of the Food and Drug Administration contact information tripled the increase in patient-reported adverse events, compared to what would have happened in the absence of the law. However, the absolute monthly increase was fewer than 0.24 reports per drug, suggesting that the public health impact of the increase was small and that the adverse event reporting rate would still be low. The study results suggest that additional measures, such as more publicity about the Adverse Event Reporting System or more consumer education, should be considered to promote patient reporting of adverse events.

Prescription Drug Promotion from 2001-2014: Data from the U.S. Food and Drug Administration

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.

An Empirical Examination of the FDAAA-Mandated Toll-Free Statement for Consumer Reporting of Side Effects in Direct-to-Consumer Television Advertisements

The volume of prescription drug promotion over time is often measured by assessing changes in ad spending. However, this method obscures the fact that some types of advertising 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.

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

This research investigates how the inclusion of the “toll-free statement” (a message about a toll-free number by which consumers can report drug side effects to the U. S. Food and Drug Administration) in direct-to-consumer (DTC) television advertisements for prescription drugs affects consumers’ comprehension of product risks and benefits, as well as their comprehension and memory of the toll-free statement. Participants viewed one of nine mock television advertisements across which elements of the toll-free statement varied. 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. These findings suggest that the toll-free statement can be added to DTC television advertisements without significantly affecting risk and benefit comprehension and that certain presentations are preferable for communicating the statement. The appropriate inclusion of the toll-free statement in DTC television advertisements may increase the visibility of the adverse event reporting system, without cost to the understanding of benefits or risks.