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.
The US Food and Drug Administration developed the Breakthrough Therapy designation to expedite the development and review of drugs that show a clear advantage over available therapy for serious ...conditions. Prior research has shown that physicians tend to misunderstand that a drug may receive a Breakthrough Therapy designation based on preliminary clinical evidence (eg, effect on a surrogate endpoint or intermediate clinical endpoint that is likely to predict clinical benefit). The objective of this article is to examine whether physicians' familiarity with and interpretation of the Breakthrough Therapy designation have changed since a survey on the topic was published in 2016. We replicated three of the questions in that study and explored beliefs that a Breakthrough Therapy designation automatically qualifies a drug for accelerated approval. We also draw comparisons by specialization (oncologists vs. primary care physicians). In general, physicians remain more likely than not to misunderstand the Breakthrough Therapy designation.
Physicians gain knowledge about medical product uses from a variety of information vehicles including FDA-approved labeling, peer-reviewed journal articles, compendia, continuing medical education ...(CME), and physician-directed promotion. The source of this information, the quality of the information, and environmental pressures such as lack of time may impact perceptions.
The authors tested the effect of three types of information sources (journal abstract, sales aid without graphics, sales aid with graphics), the presence or absence of time pressure to read the information, and two levels of methodological rigor (high, low) on perceptions of study quality, perceptions of product effectiveness and riskiness, and prescribing likelihood.
Primary care physicians (n = 630) were randomly assigned to view one version of a study abstract and then answered questions.
Participants who viewed a high-methodological rigor study reported more perceived credibility and importance of the data (ps < .05), and less need for interpreting the study data with caution and less bias than those who viewed a low-rigor study. Those who were not under time pressure to read the stimuli rated the fictitious study description as more credible, rigorous, important, and had more confidence in study data than those who were under time pressure. Participants who had less time to review high-rigor journal abstracts and sales aids with graphics were less likely to agree the study data should be interpreted with caution than doctors who had more time with the stimuli. No effects of source type were observed.
The results suggest that prominently disclosing methodological rigor helps the audience form an accurate perception of the presented information. This also further highlights the importance that any promotional communications should be truthful and non-misleading.
Purpose
FDA regulations state print ads for prescription drugs must provide a true statement of information “in brief summary” describing “side effects, contraindications and effectiveness.” To ...fulfill these requirements, these ads typically display risk information both as important safety information (ISI) on the “main” ad page with the product claims and on a separate “brief summary” page. The ISI can be lengthy and may repeat brief summary content.
Methods
The authors tested two versions of the ISI (short versus long) and the presence or absence of a brief summary in direct‐to‐consumer prescription drug print ads for two medical conditions: overactive bladder (N = 181) and rheumatoid arthritis (N = 179). Attention was measured with eye‐tracking and self‐report methods. Risk retention and perceptions were self‐reported.
Results
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.
Conclusion
A long ISI and a brief summary may perform similar functions.
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,
= 2190; Study 2,
= 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.
This study examined the impact of “New” and “#1 Prescribed” market claims and quantitative efficacy information on perceptions of a hypothetical prescription drug in a direct‐to‐consumer (DTC) print ...advertisement. We examined two market claims (New and #1 Prescribed), two efficacy levels (higher and lower), and a control condition without this information. Participants with diabetes were randomized to review one ad version and asked their perceptions of the ad's message, the drug's benefits, side effects and risks, doctors' opinions about the drug, and behavioral intention to use the drug, as well as recall and recognition of drug benefits and risks. Results 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. These findings can help inform stakeholders and policy makers as they work to ensure DTC prescription drug promotion does not mislead patients.
Direct-to-consumer (DTC) television ads for prescription drugs are required to disclose the product's major risks in the audio or audio and visual parts of the presentation (sometimes referred to as ...the "major statement"). The objective of this content analysis was to determine how the major statement of risks is presented in DTC television ads, including what risk information is presented, how easy or difficult it is to understand the risk information, and the audio and visual characteristics of the major statement. We identified 68 DTC television ads for branded prescription drugs, which included a unique major statement and that aired between July 2012 and August 2014. We used subjective and objective measures to code 50 ads randomly selected from the main sample. 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.
Background
Little is known about how physicians interpret data displays that depict preliminary or exploratory clinical data in physician‐targeted sales aids for oncology drugs. Using three factorial ...experiments, we examined whether disclosures of data limitations and clinical uncertainty adequately communicate the limitations and practical utility of this type of data.
Subjects, Materials, and Methods
The studies used a 2 (disclosure of data limitations: technical, nontechnical) × 2 (disclosure of clinical uncertainty: present, absent) + 1 (control: no disclosure) between‐subjects experimental design to examine the impact of disclosures as they relate to presentations of preliminary or exploratory data in promotional communications for oncology products. In each experiment, we randomized oncologists and primary care physicians with oncology experience to view one version of a two‐page sales aid. Following this exposure, physicians completed a web‐based survey. The design was replicated in three concurrently conducted experiments using sales aids for different fictitious oncology drugs, each featuring one of three common data displays: a forest plot (n = 495), a Kaplan‐Meier curve (n = 504), or a bar chart (n = 532).
Results
Results provide initial evidence that in some contexts disclosures can improve understanding of the clinical utility of certain information about a drug and the limitations of results presented in a data display. Disclosures can also temper perceptions of how much evidence is presented that supports a conclusion that the drug is an appropriate treatment. In terms of the language used in the disclosure of data limitations, physicians in all three experiments strongly preferred the nontechnical disclosures.
Conclusion
The findings from the three experiments in this study suggest that disclosures have the potential to increase relevant knowledge, but more research is needed to establish best practice recommendations for using disclosures to convey contextual information relevant for interpreting data displays in promotional communications.
Implications for Practice
This article reports the results from three large, online experimental studies that address a growing concern that drug companies often share favorable clinical trial results with physicians in promotional materials that lack important context for physicians to interpret the data. This series of studies investigates whether strategic use of two types of disclosures (disclosure of data limitations and a disclosure of clinical uncertainty) improves understanding and reduces misinterpretations among physicians. The results from these studies help identify communication factors that impact how physicians critically appraise preliminary or exploratory clinical trial data to inform policy and regulatory efforts.
It is unclear whether disclosures of data limitations and clinical uncertainty adequately communicate the limitations and practical utility of data displays reporting cancer drug trial results. This article examines how physicians interpret presentations of data with uncertain clinical utility in promotional communications for three different fictitious oncology drugs using three common data display types: forest plot, Kaplan‐Meier curve, and bar chart.
Opioid Education and Prescribing Practices Price, Simani M; O'Donoghue, Amie C; Rizzo, Lou ...
Journal of the American Board of Family Medicine,
2021 Jul-Aug, Letnik:
34, Številka:
4
Journal Article
Recenzirano
Lack of training among health care providers (HCPs) to safely prescribe opioids is a contributing factor to the opioid crisis. Training and other resources have been developed to educate providers ...about safe and appropriate opioid prescribing practices.
The national survey was conducted with 2000 HCPs representing primary care physicians (PCPs), including family practice, general practice, and internal medicine; specialists (SPs); physician assistants (PAs); and nurse practitioners (NPs), a mix of primary care and specialists. This survey examined exposure to opioid educational information and opioid prescribing.
PCPs reported prescribing opioids for chronic pain to significantly more patients compared with other HCP groups. PCPs (89.8%) and NPs (85.5%) reported significantly greater exposure to opioid educational information compared with both SPs (71.9%) and PAs (78.8%). Overall, HCPs had limited knowledge about abuse-deterrent formulations, but PCPs had greater knowledge than other groups. HCPs had an increased likelihood of prescribing opioids to fewer patients in the last 3 months relative to the prior 12 months if they worked in a state or county clinic vs a solo or group practice type (adjusted odds ratio AOR = 1.97; 95% confidence interval CI, 1.12-3.49) and were exposed to more opioid educational information during the last 12 months (AOR = 1.19; 95% CI, 1.06-1.32).
HCPs' exposure to opioid educational information was associated with less opioid prescribing for chronic pain. Findings indicated a difference in exposure and knowledge gaps across provider groups. More information is needed on the content of opioid educational information provided to HCPs.
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