Drug Risk Information Research Articles

Maintaining a Fair Balance? Narrative and Non-Narrative Strategies in Televised Direct-to-Consumer Advertisements for Prescription Drugs Aired in the United States, 2003–2016

Televised direct-to-consumer advertising for prescription drugs (hereafter DTCA) are among the most widespread forms of health communication encountered by American adults. DTCA shape public understanding of health problems and support the commercial interests of pharmaceutical companies by offering prescription drugs as a treatment option. The U.S. Food and Drug Administration (FDA) requires DTCA to present fair and balanced information regarding drug benefits versus risks. While narrative persuasion theory suggests that narratives can enhance persuasion by facilitating message processing and reducing counter-arguing, prior assessments of the balance between drug benefits versus risk information in DTCA have largely overlooked whether the ads employ narratives and/or other evidentiary strategies that may confer a persuasive advantage. This study content analyzed narrativity in DTCA aired on television between 2003 and 2016 for four different health conditions (heart disease, diabetes, depression, and osteoarthritis). Results showed that while televised DTCA spent more time discussing drug risks than drug benefits, both narratives and factual evidence were more frequently used to communicate drug benefits than drug risks. These findings raise concerns that narratives are strategically used by DTCA to highlight drug benefits rather than drug risks, which could lead to inaccurate perceptions of drug risks among viewers.

Aliterate Consumers’ Processing of Drug Risk Information inDirect-to-Consumer Pharmaceutical Advertising

This research investigates how aliterate consumers process drug risk information. An experimental approach and 398 participants were employed to assess the effects of manipulating drug risk presentation format. When drug risk information is presented in paragraph form, highly consumer aliterate individuals display lower levels of drug risk comprehension and different levels of perceived drug risk than their less-consumer aliterate peers. Providing the same information in a bullet format attenuated consumer aliteracy driven differences in comprehension and eliminated differences in perceived drug risk. These results hold important ethical implications regarding how risk information is disclosed in direct-to-consumer pharmaceutical advertising.

Experimental study of consumer responses to different sources of information about prescription drugs

Abstract Consumers receive risk information about prescription drugs from many sources, including from largely unregulated attorney advertisements. This experiment measures subjective risk beliefs about prescription drugs and subjects’ drug-taking behavior in an incentivized setting. Results of the experiment are used to estimate a Bayesian learning model to ascertain the risk levels implied by different information sources and the informational weights subjects place on these sources. Even after people have received scientifically based drug risk information from a doctor and product label, attorney litigation advertising boosts risk beliefs about side effects by an average of 16 out of 100 cases, which is roughly a 50% increase over baseline risk beliefs. Risk beliefs have a significant effect on drug-taking behavior in an incentivized environment. Experience with taking the drug also feeds back into the learning process about risk beliefs. Our experimental results help formalize how consumers update risk beliefs and suggest ways to encourage a learning environment that avoids alarmist updating based on information sources like attorney advertising.

Experimental Study of Consumer Responses to Different Sources of Information about Prescription Drugs

Consumers receive risk information about prescription drugs from many sources, including from largely unregulated attorney advertisements. This experiment measures subjective risk beliefs about prescription drugs and subjects’ drug-taking behavior in an incentivized setting. Results of the experiment are used to estimate a Bayesian learning model to ascertain the risk levels implied by different information sources and the informational weights subjects place on these sources. Even after people have received scientifically based drug risk information from a doctor and product label, attorney litigation advertising boosts risk beliefs about side effects by an average of 16 out of 100 cases, which is roughly a 50% increase over baseline risk beliefs. Risk beliefs have a significant effect on drug-taking behavior in an incentivized environment. Experience with taking the drug also feeds back into the learning process about risk beliefs. Our experimental results help formalize how consumers update risk beliefs and suggest ways to encourage a learning environment that avoids alarmist updating based on information sources like attorney advertising.

The effectiveness of direct to healthcare professional communication - A systematic review of communication factor studies.

Direct to healthcare professional communication (DHPC) is the prevalent regulatory measure to inform about and potentially mitigate newly identified drug risks in EU and USA. According to multiple studies and reviews, however, the effectiveness of DHPC to reduce risk is less than optimal. Prior systematic reviews have indicated that contextual, qualitative knowledge of communication factors related to the clinical setting is needed to further explain and supplement findings in quantitative effectiveness studies. This article systematically reviews studies of DHPC and, on that basis, describes the communication factors that influence the effectiveness of DHPC in order to discuss future research trajectories. PubMed, Scopus (including Embase) and Web of Science databases were searched for studies on communication about emergent drug risk to healthcare professionals, excluding studies limited to the quantifiable effect of communication. The search results were deductively categorized using the Communication Sequence Model. Then, prevalent themes within categories were identified and described using thematic analysis. A total of 16 studies published between 1993 and 2017 were included; 12 based on surveys, 2 on document analysis, and 2 primarily on interviews. The prevalent themes included "Health Care Professionals (HCPs) have less trust in communication from industry than authorities and medical associations", "HCPs have diverse preferences for how to receive drug risk information" and "Clinical usability of the presented information is less than optimal." Communication factors in DHPCs are multiple, multi-facetted and are examined primarily by surveys. Future research would benefit from identifying nationally dependent factors and employing methods that better provide knowledge on the qualitative reception and handling of drug risk communication.

Testimonials and Informational Videos on Branded Prescription Drug Websites: Experimental Study to Assess Influence on Consumer Knowledge and Perceptions.

BackgroundDirect-to-consumer (DTC) promotion of prescription drugs can affect consumer behaviors and health outcomes, and Internet drug promotion is growing rapidly. Branded drug websites often capitalize on the multimedia capabilities of the Internet by using videos to emphasize drug benefits and characteristics. However, it is unknown how such videos affect consumer processing of drug information.ObjectiveThis study aimed to examine how videos on prescription drug websites, and the inclusion of risk information in those videos, influence consumer knowledge and perceptions.MethodsWe conducted an experimental study in which online panel participants with acid reflux (n=1070) or high blood pressure (n=1055) were randomly assigned to view 1 of the 10 fictitious prescription drug websites and complete a short questionnaire. On each website, we manipulated the type of video (patient testimonial, mechanism of action animation, or none) and whether the video mentioned drug risks.ResultsParticipants who viewed any video were less likely to recognize drug risks presented only in the website text (P≤.01). Including risk information in videos increased participants’ recognition of the risks presented in the videos (P≤.01). However, in some cases, including risk information in videos decreased participants’ recognition of the risks not presented in the videos (ie, risks presented in text only; P≤.04). Participants who viewed a video without drug risk information thought that the website placed more emphasis on benefits, compared with participants who viewed the video with drug risk information (P≤.01). Compared with participants who viewed a video without drug risk information, participants who viewed a video with drug risk information thought that the drug was less effective in the high blood pressure sample (P=.03) and thought that risks were more serious in the acid reflux sample (P=.01). There were no significant differences between risk and nonrisk video conditions on other perception measures (P>.05). In addition, we noted a few differences among the types of videos.ConclusionsIncluding risks in branded drug website videos may increase in-video risk retention at the expense of text-only risk retention.

Drug safety in pregnancy: the German Embryotox institute.

Since 1988, the German Embryotox institute combines individual counselling of pregnant women and their health care providers (HCP) with research on drug safety in pregnancy. In addition, Embryotox offers web-based information which covers the most important and most frequently requested pharmaceutical substances. In contrast to ready-made drug risk information in package leaflets and other product information, individual counselling considers different clinical settings such as (1) looking for a drug of choice or planning pregnancy under medication, (2) risk assessment of a particular drug that has already been taken during an (unplanned) pregnancy and (3) evaluation of an adverse pregnancy outcome in association with a particular medication. Using the three established developmental toxicants valproic acid, isotretinoin, and renin-angiotensin-aldosterone system (RAAS) inhibitors as an example, the need of detailed information is illustrated. Through the risk communication process, pregnancy outcome data are routinely collected by Embryotox. This approach uses the advantages of a pre-existing communication structure and of dealing with motivated responders. Engagement in the treatment plan facilitates receiving reliable data on drug exposure as well as detailed follow-up data. Based on these patient records, prospective datasets are evaluated in observational cohort studies in comparison to non-exposed control cohorts. In addition, retrospective datasets received as suspected adverse drug reactions from multiple German sources allow a screening for signals of teratogenicity and distinct patterns of developmental toxicity. Clinical expertise in specialties such as teratology, paediatrics, embryology, obstetrics and human genetics are required to ensure high-quality assessment of drug safety in pregnancy.

Attention to and Distraction from Risk Information in Prescription Drug Advertising: An Eye Tracking Study.

Direct-to-consumer (DTC) television ads must disclose a drug's most important risks. Currently, the risks must be in audio at a minimum. Studies have shown that presenting information with both audio and superimposed risk text (dual-modality) improves recall beyond that of using audio alone. However, distracting elements in DTC ads may draw attention away from the superimposed risk text. This study combined eye-tracking data with questionnaire data to examine whether distracting elements decrease attention to the risk text in DTC ads, in turn affecting risk retention and risk perceptions. The authors randomly assigned 300 U.S. opt-in panel members to view either a low-distraction or a high-distraction DTC television ad. The authors found that distracting elements during risk presentation drew attention away from the risk text and, in turn, reduced retention of drug risk information. Risk perceptions were not affected. These results suggest that even if dual-modality is used to increase consumer's comprehension of drug risk information, distracting visuals should still be avoided in order to help consumers focus on key information in the ad.

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

Broadcast direct-to-consumer (DTC) prescription drug ads that present product claims are required to also present the product's major risks. Debate exists regarding how much information should be included in these major risk statements. Some argue that such statements expose people to unnecessary amounts of information, while others argue that they leave out important information. Examine the impact of type of risk statement (unedited versus serious and actionable risks only) and a disclosure indicating that not all risks are presented on consumers' ability to remember the important risks and benefits of a drug following exposure to a DTC television advertisement (ad). Risk and benefit perceptions, ad-prompted actions, recognition of the disclosure statement, and evaluations of both the disclosure and risk statement were also examined. 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.

A mixed-methods approach to assessing actual risk readership on branded drug websites

Despite FDA requirements that drug benefits and risks be presented in a ‘fair balance’ manner, little is known about the extent to which individuals actually seek and process risk information. Self-report measures of drug risk reading show mixed results. This exploratory study investigates this topic within the context of a branded prescription drug website for a fictional seasonal allergy drug. We use a mixed-methods approach involving eye-tracking, survey and qualitative data. While approximately 80% of participants (N = 29) claimed to have read half or more of the risk information, eye-tracking measures revealed limited to no risk reading when given the opportunity to freely view the site without explicit directions to read risk information. Survey results showed minimal unaided recall and modest aided recall of risks. To gain insight into why participants failed to seek drug risk information, we analyzed retro-active think aloud post-task interviews for potential explanations and looked for expressions of social desirability, information avoidance, optimism bias and familiarity. Perceived familiarity with the health condition, its risks and companion drug options surfaced as the primary explanation for failure to seek, and subsequently process, the risk information. This perceived familiarity prompted participants to ignore the risk information and discount the commercial information source. We offer practical recommendations to encourage risk reading in light of our findings.

Consumer Understanding, Preferences, and Responses to Different Versions of Drug Safety Messages in the United States: A Randomized Controlled Trial.

IntroductionAs part of its mission, the US Food and Drug Administration (FDA) communicates with the public regularly about the benefits and risks of prescription and over-the-counter (OTC) drugs. Effectively communicating risk, however, is a significant public health challenge.ObjectiveTo better understand how different populations understand information communicated by the FDA about drug safety, we conducted a randomized experiment to examine comprehension and other measures of effectiveness of drug safety messages that occurred in a post-market surveillance phase.MethodsWe used an Internet panel survey of 1244 consumers, of whom 58 % used prescription drugs in the past year. Half of the sample panel was randomized to read a previous FDA Drug Safety Communication (DSC) with the drug name changed, and the other half was randomized to read a revised version of the same DSC. We examined how making certain modifications to the way drug risk information is communicated has an impact on comprehension and behavioral intentions, including the user’s likelihood of discontinuing the drug. We also studied how comprehension varied by respondent characteristics, health literacy skills, risk perceptions, and trust in the message.ResultsBased on a five-item comprehension index, the revised version of the message was associated with significantly greater comprehension of the information relative to the standard version (63 vs 52 % correct, p < 0.001). Significantly more respondents found the revised version to be clear (82 vs 73 %, p < 0.000), while fewer in that group reported learning something new (78 % vs 84 %, p = 0.015). No significant differences emerged between the two groups in terms of the message being informative, convincing, or helpful. We found no significant differences between the two groups in terms of behavioral intentions, risk perception, and trust.ConclusionsWe found that making plain language changes to the DSC significantly increased consumers’ level of comprehension of its content, providing support for ongoing use and further exploration of these strategies in pharmacovigilance communication research. The study findings have important implications for future drug safety and other communication messages related to prescription drugs.Electronic supplementary materialThe online version of this article (doi:10.1007/s40264-015-0358-9) contains supplementary material, which is available to authorized users.

Focus on Health Literacy: Recommendations to Improve European Union Risk Management Plan Public Summaries.

The complexity of drug risk information often exceeds patients' abilities to understand and effectively act on it. The authors evaluated a layperson-focused European Union Risk Management Plan Public Summary and revised it to improve its understandability and usability by applying health literacy principles. The Suitability Assessment of Materials was used to test the appropriateness of the document for readers with low-to-average literacy levels. Two rounds of usability tests were conducted with American adults who had low to average education levels to identify areas of confusion. Revisions were made within perceived regulatory constraints. A number of health literacy principles can be applied to improve the understandability and usability of the document; however, the document contains many inherently complex concepts. The authors recommend that stakeholders reassess the intended use of the document by members of the public and rethink its scope and structure, with close involvement of patients and caregivers.

Important Safety Information or Important Risk Information? A Question of Framing in Prescription Drug Advertisements.

The summary of risks in a prescription drug print advertisement is typically headlined either "Important Safety Information" or "Important Risk Information." Research has shown that words used to frame information can influence interpretation of the information. We examined the impact of headline framing on risk perception among consumers viewing prescription drug ads. Participants (N = 2000) were randomly assigned to see the title "Important Safety Information" or "Important Risk Information" before reading a description of risks for a fictitious drug. Participants then answered questions about the perceived risk of the drug, attempted to recall the section heading, and reported demographic characteristics. Results revealed no differences between participants in the 2 conditions, suggesting that framing drug risk information in terms of its safety or risk does not differentially affect consumer risk perception.

SAFE USE OF DRUGS DURING PREGNANCY IN FOCUS OF INTERNATIONAL PRACTICE OF PHARMACOVIGILANCE SYSTEM AND TERATOLOGICAL INFORMATION SERVICE ORGANIZATION

научный биометрический журнал, который знакомит читателя с клиническими рекомендациями и особенностями применения лекарственных и вакцинных средств у детей, предоставляет исчерпывающую информацию о воздействии лекарственных средств на плод, о проводимых в

Trends in co-prescribing of antidepressants and tamoxifen among women with breast cancer, 2004–2010

Nearly a decade ago, researchers identified a potential interaction between tamoxifen and strong CYP2D6 inhibitors, including several frequently used antidepressants. Based on evidence available at that time, a United States Food and Drug Administration advisory committee recommended tamoxifen's label be changed in October 2006, noting that postmenopausal women with estrogen receptor-positive breast cancer who are poor CYP2D6 metabolizers by genotype or drug interactions may be at increased risk of cancer recurrence. The impact of accumulating drug risk information on antidepressant use is unknown. We conducted a retrospective, longitudinal cohort study of 13,205 women aged 50-95 with breast cancer initiating tamoxifen between July 2004 and December 2009. We evaluated trends in strong, moderate, and weak CYP2D6-inhibitor antidepressants and tamoxifen co-prescribing and factors associated with ongoing strong inhibitor use. A propensity score matched control group (aromatase inhibitor initiators) was used to estimate changes in co-prescribing, accounting for secular trends. In each month, approximately 24 % of tamoxifen and aromatase inhibitor users were prescribed antidepressants. Among women using tamoxifen and antidepressants, 34 % used strong inhibitors between 2004 and 2006 versus 15 % in 2010. Strong inhibitor use decreased more among tamoxifen users than aromatase inhibitor users (difference-in-differences [DD] -0.09; 95 % confidence interval [CI] -0.15, -0.03). Weak inhibitor use increased among tamoxifen users from 32 % between 2004 and 2006 to 52 % in 2010, more rapidly than among aromatase inhibitor users (DD 0.15; CI 0.08, 0.23). The factor most strongly associated with strong inhibitor and tamoxifen co-prescribing after 2006 was prior strong inhibitor use (RR 4.73; CI 3.62-6.18). In conclusion, there were substantial declines in strong CYP2D6-inhibitor use among tamoxifen users following dissemination of information suggesting a potential for increased risk with co-prescribing. Whether patients and providers will continue to avoid strong inhibitor antidepressants is yet to be seen, but clinicians appear to be responsive to drug interaction risk information in this setting.

Consumer Response to Drug Risk Information: The Role of Positive Affect

Risk disclosure is an essential element of the marketing of prescription drugs and other medical products. This study examines how consumers respond to verbal information about the frequency and severity of medical-product risks and how media-induced affect can moderate such responses. The study finds that consumers tend to overestimate the actual likelihood of adverse events described with words such as “common” or “rare” (compared with the probabilities such terms are typically intended to convey) and that consumers tend to give little weight to such probability language when forming product use intentions. However, consumers in positive media-induced moods seem to engage in more nuanced evaluation of product risk information, weighing both frequency and severity information and using such information to make inferences about other product attributes (e.g., product efficacy). These findings suggest that medical marketers and regulators need to devise more effective means of communicating risk probability to consumers and that positive mood induction (e.g., by placing advertisements in upbeat media environments) can enhance consumers’ ability to process product risk information.

Consumer Response to Drug Risk Information:The Role of Positive Affect

Abstract Risk disclosure is an essential element of the marketing of prescription drugs and other medical products. This study examines how consumers respond to verbal information about the frequency and severity of medical-product risks and how media-induced affect can moderate such responses. The study finds that consumers tend to overestimate the actual likelihood of adverse events described with words such as “common” or “rare” (compared with the probabilities such terms are typically intended to convey) and that consumers tend to give little weight to such probability language when forming product use intentions. However, consumers in positive media-induced moods seem to engage in more nuanced evaluation of product risk information, weighing both frequency and severity information and using such information to make inferences about other product attributes (e.g., product efficacy). These findings suggest that medical marketers and regulators need to devise more effective means of communicating risk p...

Managing Drug-Risk Information — What to Do with All Those New Numbers

The FDA's proposed Sentinel system for postmarketing surveillance will generate many safety signals, some of which will be false alarms. Drs. Jerry Avorn and Sebastian Schneeweiss explore the challenges to interpretation of those signals, as well as questions about communicating their meaning effectively.

Hepatitis and Human Immunodeficiency Virus Co-Infection Among Injection Drug Users in Los Angeles County, California

This study examined the prevalence of hepatitis A (HAV), B (HBV), C (HCV), and Human Immunodeficiency Virus (HIV) co-infection among Injection Drug Users (IDUs) in Los Angeles County, California, and predictors of multiple infections in this population. Six hundred seventy-nine IDUs were recruited from October 2002 through June 2004. Participants completed questionnaires to elicit demographic, drug and sex risk information, and were tested for hepatitis A, B, C and HIV. A linear regression model predicting the total number of infections (0 to 4 possible) was constructed. Significant associations were found between HAV and HBV infection, HAV and HCV infection, and HBV and HCV infection. Predictors of total co-infections included age of first injection, lifetime years in jail, and Hispanic ethnicity. Latinos had the highest proportion of HAV and HBV co-infection with HCV. The total number of co-infections, especially those co-infected with all three of the hepatitis infections, was unexpectedly high.