Product Warnings Research Articles

Patterns of use, knowledge, and perceived effects of sedating medication on driving: A questionnaire survey of Japanese drivers who use sedating medication

ObjectiveThis study was designed to investigate patterns of medication use among drivers using pharmaceutical drugs, the subjective impact of medication use on driving, and knowledge about the effects of medication use on driving. MethodsAn online survey was administered to a sample of Japanese drivers (n = 1424, age range 21–79 years) to investigate the use pattern of major sedating medications such as cold/sinus drugs, anxiolytics, hypnotics, and antidepressants. The strength of association between variables pertaining to the use of sedating medications and self-reported at-fault crash involvement was explored using a series of multivariate logistic regression models. ResultsOn average, respondents reported using 2.7 sedating medications over the past two years (standard deviation = 1.8; range = 0–11). The pattern of psychotropic medication use was diverse, and the use of multiple psychotropic medications was common. Respondents could be grouped into four subgroups in terms of multiple medication use. Irrespective of the type of medication taken, respondents noticed few adverse side effects of medication on driving and generally did not adhere to driving-related product warnings; some respondents were unaware of important facts such as the exacerbation of the effects of medication effects when combining medications. Multivariate logistic regression analyses showed that the presence of a higher number of sedating agents in the medication taken was positively associated with reporting an at-fault crash in the last two years, having longer driving distance, being a commercial driver, receiving more traffic tickets, and having a higher tendency for rules violations. ConclusionsThe present study showed that medication use by drivers is diverse and complex, that most drivers are not sufficiently informed of the potentially impairing effects of medication, and that poly-medication use appeared prevalent among those who use psychotropic medications. In line with previous studies, the current study reveals a need for better communication between health experts and patients and for education of all stakeholders. The results also highlighted the need for systematic investigation into cause of crash in light of potential contribution of sedating medication used by the driver, given the low autopsy rate for fatally injured drivers in Japan.

Advancing Tobacco Product Warning Labels Research Methods and Theory: A Summary of a Grantee Meeting Held by the US National Cancer Institute.

The World Health Organization's Framework Convention on Tobacco Control recommends prominent pictorial health warnings on tobacco products. To advance research methods, theory and understanding of how tobacco product warning labels (TPWLs) work, the US National Cancer Institute convened a grantee meeting. Our article describes the key insights that emerged from the meeting, situated within the context of the scientific literature. First, presentations confirmed that large, pictorial TPWLs motivate people to try to quit and encourage smoking cessation. Second, pictorial TPWLs increase attention, knowledge, negative affect, and thinking about the warning. Third, TPWL studies have primarily used brief-exposure laboratory studies and observational studies of sustained exposure through national policy implementation, with a few randomized trials involving several weeks of exposure-with generally consistent results found across study designs. Fourth, novel assessment methods include brain imaging, eye tracking and "best-worst" discrete choice experiments. To make TPWL even more effective, research is needed to confirm the mechanisms of their influence, their impact across vulnerable populations, and their effect on social media posts about tobacco products. Research is also needed on the effect of trial design choices, the predictive validity of new measurement approaches, and warning labels for non-cigarette tobacco products. To improve scientific understanding of TPWL effects, this grantee meeting summary describes emerging research methods, theory and study results. Directions for future research include examination of the mechanisms of how warning labels work across diverse tobacco products and across different populations and contexts.

Systematic Review of Health Communication for Non-Cigarette Tobacco Products

ABSTRACTThe Food and Drug Administration, which now has regulatory authority over all tobacco products meeting the statutory definition, is tasked with communicating the risks of these products to the public through health warnings and public education. However, there have been no attempts to summarize what is known about non-cigarette tobacco product (NCTP) health messaging. We conducted a systematic review to examine the existing literature on health communication for NCTPs and identify key research gaps. A total of 45 unique studies were retrieved and coded, with the majority focused on messaging for smokeless tobacco (SLT, k = 32, 71.1%), followed by waterpipe tobacco (WT, k = 9, 20%), electronic nicotine delivery systems (ENDS, k = 2, 4.4%), cigars (k = 2, 4.4%), and a potentially reduced exposure product (k = 1, 2.2%). Studies most commonly examined tobacco product warnings (k = 26, 57.8%) and public education (k = 19, 42.2%), which included mass media campaigns. Most studies examined knowledge, attitudes, and beliefs as outcomes (k = 27, 60%), while behavior was an outcome in the minority of studies (k = 8, 17.8%). Pictorial warnings and public education about NCTPs demonstrated positive impact in some studies, although the literature is nascent. Given the increasing use of NCTPs such as ENDS, WT, and cigars, particularly among adolescents and young adults, more research is needed on effective ways to communicate product risk to those audiences most at risk.

User-Centered Label Design Guidelines for Child Restraint Systems

Child Restraint Systems (CRS; car seats) are designed to prevent injuries in motor vehicle collisions. CRS misuse and installation errors are common and may seriously reduce or nullify safety benefits. Poorly designed labels and instructions contribute to CRS misuse, and CRS manufacturers are not held to an evidence-based label design standard. This paper describes a user-centered design (UCD) and evaluation process for infant/child convertible (rear-facing/forward-facing) CRS installation labels. The labels focused on two primary tasks: installing a CRS into a vehicle and securing a child into the CRS. The label design concepts were based on literature identifying primary areas for CRS misuse, Human Factors and UCD principles, product warning and label design standards, and current Canadian and US motor vehicle safety standards. A follow-up study will evaluate the reduction of CRS installation errors based on the hypothesized enhanced label usability and effectiveness.

A Qualitative Investigation of Australian Young Adult Responses to Pictorial and Graphic Alcohol Product Warnings

This qualitative study aimed to understand whether pictorial and graphic alcohol warnings would be an effective intervention to reduce alcohol-related harms among young adult drinkers. Four focus groups ( n = 26) were conducted examining impressions, reactions, and thoughts about five pictorial warnings and five graphic warnings. Students (58% female) from Melbourne, Australia, aged 18 to 25 years who consumed alcohol participated. The warnings used in this study elicited strong negative emotional reactions, including avoidance. While the use of images increased the salience of the warnings, participants discussed the likelihood of habituation, indicating warning rotation is needed. Targeted messages and statistics appealed to the participants. However, they were unlikely to change their drinking behavior due to the warnings. Consistent with tobacco warning literature, and in line with behavior change and message persuasion theory, warning labels with photographic images and targeted statistics were found to have the most persuasive impact against risky drinking within this sample.

Responsible gambling codes of conduct: lack of harm minimisation intervention in the context of venue self-regulation

Responsible Gambling Codes of Conduct (CoC) are used around the world to describe electronic gambling machine (EGM) operator commitments to reducing harm from gambling. In addition to the provision of passive product information and warnings, CoC describe how venues should assist EGM users displaying signs of problematic gambling. The focus in this paper is on venue adherence to the active strategies described in these documents relating to supporting ‘responsible gambling’ and discouraging harmful, intensive and extended gambling. The paper triangulates data from aspirational statements by EGM operators published in CoC documents; structured, unannounced observations by the research team in 11 EGM venues; and interviews and focus groups conducted with 40 gamblers and 20 professionals in Melbourne, Australia. Results showed only isolated evidence of supportive interactions between staff and gamblers to address gambling harm. The weight of evidence demonstrated that venues often fail to respond to signs of gambling problems and instead encourage continued gambling in contradiction of their CoC responsibilities. Signs of gambling problems are a normalised feature of EGM use in these venues. To genuinely address this public health and public policy challenge, improved consumer protection for gamblers may be achieved through legislation requiring venues to respond to signs of gambling problems. This may include a range of measures such as banning food and beverage service at machines and limiting withdrawals of cash by gamblers, as well as using behavioural tracking algorithms to identify problematic gambling patterns and binding universal pre-commitment systems to complement supportive interventions by venue staff.

Alcohol policy and public health

SummaryAlcohol is the most commonly used recreational drug in the world and the third leading cause of preventable death. Alcohol consumption and alcohol problems have increased steadily over the past six decades. Methods likely to reduce alcohol problems (e.g. minimum pricing, restricting licensing hours and increasing the availability of alcohol treatment) tend not to be supported by the drinks industry. Methods favoured by the industry (e.g. public education, industry self-regulation and product warning labelling) are less effective or do not work. The recent history of alcohol policy clearly demonstrates how the financial power of industry can influence governments and undermine effective public health measures, for instance by lobbying, political donations, confusion marketing and creating fnancial vested interests by grants from industry-sponsored 'social aspect organisations'.

Product warnings and the involuntary capture of attention

In both published papers and in guidelines of regulatory agencies and voluntary standards, examples can be found where the assumption is made that what will capture attention is that which is salient or conspicuous, and that these qualities are both necessary and sufficient to capture attention. A review of the published, peer-reviewed literature on attention capture, however, invites the conclusion that there are very few features of an object that will draw attention to themselves without or against the observer’s intentions. The ability of warnings to draw attention to themselves involuntarily is discussed within the context of the extant attention capture literature.

Fundamental rights protection against market-related information activity: the case of multilevel product warnings

While fundamental rights protection against market-related information activity has been a controversial issue for decades, at least within some Member States of the European Union, such as Germany, it increasingly becomes a challenge regarding the multilevel product safety administration in the EU internal market. This article addresses the requirements, the present design and remaining shortcomings of fundamental rights protection against Europe-wide product warnings, particularly, with regard to the right to conduct a business (Art. 16 of the Charter of Fundamental Rights of the EU). The traditional concept of fundamental rights protection, which is mainly based on the assumption that legal bases contain formal and substantive requirements to instruct and restrict the exercise of public authority, which in turn is subject to judicial review, does not any more provide effective and comprehensive fundamental rights protection in this field. Rather, comprehensive and effective fundamental rights protection in a complex system of information activities requires that numerous means complement each other: among many examples, preliminary conjunctions, damage claims as a “second best”-option and mainly adequate administrational organization and procedure are of major importance.

Avoiding Litigation for Product Instructions and Warnings

The plaintiff suing for injuries arising from a product with allegedly defective instructions or warnings has the burden of proving each of the elements for every cause of action asserted, while the defendant prevails by defeating just one element for each cause of action. Technical communicators can increase their legal literacy by learning the elements that are most easily defeated and thereby avoid subjecting their product instructions and warnings to litigation. This article surveys the existing scholarship to show the need for more attention to legal terms, theory, and practice before explaining how lawyers approach litigation. The article then turns to each of the main causes of action—the functional approach of the Restatement (Third) of Torts: Products Liability, negligence, and breach of express warranty and misrepresentation—with an emphasis upon the elements that are most within the control of the technical communicator.

A Perceptual Analysis of Standard Safety, Fluorescent, and Neon Colors

Twenty-six standard safety colors specified by the American National Standards Institute (ANSI), International Standards Organization (ISO), and the Federal Highway Association (FHWA) were compared to seven fluorescent and neon colors on perceived hazard and perceived importance. Results indicated that the fluorescent orange, ANSI red, fluorescent yellow, FHWA red, fluorescent yellow green, and ISO red were the highest rated colors on perceived hazard. ANSI red, FHWA red, ISO red, fluorescent orange, fluorescent yellow, and fluorescent yellow green were rated the highest on perceived importance. The implications of these findings and the potential use of fluorescent colors in product warnings are discussed.

The Effects of Education and Incongruent Images on Product Warnings

The research reported in this article investigates how the education level of consumers affects liking and safety feeling toward a product when incongruent images are present with product warnings. The current study used a 2 by 2 experimental methodology to investigate underlying psychological processes of adult consumers who have varying levels of education. The current study finds that relative to high-education consumers, low-education consumers (those who did not complete high school) were more significantly affected by the presence of incongruent images in the product warnings. They displayed higher liking and more safety feeling toward a product when warnings accompanied incongruent images versus warnings with no images. This effect is not found among high-education consumers. That result has alarming implications. Low-education consumers may be unable to critically evaluate product warnings and can be persuaded to misjudge product warnings and product safety when product warnings include incongruent images. The current research extends the previous research on low-education consumers by studying the impact of incongruent images in the product warnings. Specifically, we focus on investigation of subjective attitude formation of warnings (liking and safety feeling) in the presence of incongruent images which was not investigated in the past.

Perigo, cuidado, atenção: a comunicação linguística de risco em advertências de produtos

Este artigo tem como foco central as advertências de produtos. Inicialmente, revisamos o que os linguistas Dumas, Fraser e Shuy discutem sobre a definição e avaliação de advertências, para depois examinar textos reais. Nós analisamos detalhadamente uma série de advertências de tintura capilar a fim de verificar os problemas de compreensão que elas criam para seus Leitores e até que ponto elas são deficientes. O artigo termina com uma análise detalhada de uma série de advertências de um caso da corte Canadense onde um homem moveu uma ação judicial para reparação de danos contra a empresa que fabricou o BBQ depois que o BBQ explodiu causando queimaduras de terceiro grau em seu filho. Ele alegou que as advertências eram inadequadas.

Product Warnings, Debiasing, and Free Speech: The Case of Tobacco Regulation

Product Warnings, Debiasing, and Free Speech: The Case of Tobacco Regulation

Product Warnings, Debiasing, and Free Speech: The Case of Tobacco Regulation

The Family Smoking Prevention and Tobacco Control Act of 2009 requires the display of graphic health warnings on cigarette advertising and packaging in the United States. Debates over the permissibility of these new mandated health warnings under the unusually broad Free Speech Clause of the United States Constitution have paid insufficient attention to empirical evidence - to be presented in this article - of the warnings' salutary effects in reducing consumers' factual misperceptions about smoking risks. Although such empirical evidence does not, by itself, settle the First Amendment debate, this evidence warrants more attention in that debate than it has received to date.

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Introduction: In patients with massive and submassive pulmonary embolism (PE), alteplase administration enhances the rate of clot resolution and improves hemodynamics, but increases the risk for bleeding. Factors available to clinicians at the time alteplase is administered, such as product package insert-noted contraindications and warnings (CI/W) for alteplase administration and body weight, may be associated with bleeding. Hypothesis: Lower body weight is independently associated with a higher risk for bleeding compared to higher body weight. Methods: This retrospective, case-control study included adult patients who received alteplase 100 mg over 2 hours for the treatment of PE. Bleeding was defined as any of the following within 72 hours post-alteplase: death from bleeding, radiographic evidence of hemorrhage, procedure to treat bleeding, transfusion of two or more units of packed red blood cells, or a reduction in hemoglobin of 2 g/dL or more during each 24 hour period. The primary objective was to compare body weight between cases (patients meeting bleeding criteria) and controls (non-bleeding patients). Secondarily, the influence of risk factors for bleeding was evaluated with logistic regression. Results: Ninety nine patients were screened from January 2000 to August 2011, with 62 patients included. At baseline, 45% of patients had massive PE, while 53% had submassive PE. Overall, 28 patients (45%) experienced bleeding. There was no difference in median body weight between cases and controls (95 vs. 101 kg; p=0.098). However, significantly more case patients had at least one CI/W for alteplase administration (61% vs. 24%, p=0.003) and massive PE (61% vs. 32%, p=0.04). On multivariate logistic regression, presence of CI/W for alteplase administration (OR 5.2, 95% CI 1.6-17.5, p=0.007) and body weight (OR 0.84 per 10 kg, 95% CI 0.72-0.98, p=0.023) were independently associated with bleeding. Conclusions: Bleeding occurred relatively frequently in this cohort of patients receiving alteplase for PE. Lower body weight was associated with a higher bleeding risk on multivariate analysis.

Review of red yeast rice content and current Food and Drug Administration oversight

Red yeast rice (RYR) is a commonly used dietary supplement for the management of dyslipidemia. In 2007, the Food and Drug Administration (FDA) issued a consumer warning to avoid RYR products because they may contain unauthorized drug (lovastatin) and also implemented Current Good Manufacturing Practices (CGMP) requiring that proper controls be in place by dietary supplement companies to ensure products are manufactured and processed in a consistent manner and produce high-quality products that are not adulterated with impurities or contaminants and are accurately labeled. To assess the FDA oversight of companies manufacturing RYR products and review the labeled content of available RYR products. The FDA was audited through the Freedom of Information Act, we requested answers to a series of questions concerning their oversight of companies manufacturing RYR products. The labeled content of each RYR product listed in the Natural Medicines Comprehensive Database (NMCD) was tabulated and summarized. Statin-related product warnings and if product certification and verification by an independent laboratory had been performed were documented. The FDA had no information on the number of RYR manufacturers and their compliance with CGMP regulations. A total of 101 products containing RYR were reviewed. No product could be confirmed as passing any independent laboratory verification testing. Nearly one-half (42.6%) of the RYR product labels contained statin-related warnings (ie, potential for muscle pain or weakness, etc). Currently, the FDA is not regulating manufacturers of RYR products and as a result, many of these products may contain monacolin K and toxins such as citrinin.

Improving Public Response to Disaster Warnings: A Discussion Panel

Stories about substantial human and property losses caused by natural disasters made headlines in 2011 throughout the U.S. and around the world. Many of these stories described problems with the disaster warnings themselves as well as with human responses to these warnings, both of which may have increased the number of casualties. Although human factors research has made significant contributions to the design of product warnings in general, studies focused specifically on disaster warnings and associated responses are sparse (Cooke & Winner, 2007). Furthermore, disseminating warnings and supplemental information to guide decision making by the general public is increasingly challenging due to the rapid adoption of heterogeneous mobile technologies, particularly those providing Internet access. These technologies facilitate access to even more information during these time-sensitive situations, but the information may not be presented in ways that support effective decision-making. In this panel, we will discuss opportunities for human factors research to improve the public’s preparation and response to disaster warnings. Panelists will discuss their research on individual differences in warning design and response, training effects on warning response, social media and emergency communications, communication and coordination among ad hoc disaster response teams, and decision making by weather forecasters. From these discussions, we hope to identify research areas with high potential for short-term impact.

Reading Pages of a Consumer Product Manual Text and Warnings: Effects of Format Salience and Visual Cues on Eye Movements

This study evaluated whether high or low salience product manual warning formats resulted in different frequencies of both reading and warning recall accuracy. Both experimental conditions constituted an amalgamation of warning and product manual format features. The low salience condition was comprised of a capitalized signal word, paragraph prose-style warning text, warnings integrated with page content with low salience visual cues whereas the high salience condition included an icon, signal word panel, bulleted warning text, warnings placed separately at the page bottom with high salience visual cues. Eye movements were recorded while participants read pages from product manuals followed by a warning recall test. No significant difference in the number of warnings read was found but visual cues in the high salience condition shifted foveal vision to the warnings significantly more often than the cues in the low salience condition. Warning recall was higher in the low salience condition than in the high salience condition, probably because of the particular task and formatting used. Caveats and study implications are discussed.

A three-stage model summarizes product warning and environmental sign research

The past 25years have experienced a substantial amount of research on safety communications, more specifically, warnings. This article focuses on the most important factors in designing effective warnings. The warning process is modeled in three stages. Effective warnings attract attention; elicit knowledge, and enable compliance behavior. Two main categories are design factors and non-design factors. Non-design factors include the effects of target audience and situational factors. For attention, important design factors are size, color/contrast, signal word, graphics, and format. The non-design factors for attention include context, location, and distraction. Design factors affecting the knowledge and compliance stages include explicit wording and pictorials to provide hazard, consequences and instructional content. Non-design factors for the knowledge stage include familiarity and perceived hazard. Non-design factors for the compliance stage include modeling the behavior of others and cost of compliance. The research literature offers practical design recommendations to aid application decisions.