Current Challenges in Labelling for Generic Medicinal Products: Company Core Data Sheet (CCDS) Development and Maintenance.

Labelling of pharmaceutical products plays a vital role in the safe and effective use of approved medicinal products. This information may be provided to end-users including patients and/or prescribers, and it needs to be made available in multiple formats including printed forms (patient information leaflets, pack inserts, etc.) or web portals of the product, based on national authority guidelines. The Company Core Data Sheet (CCDS) serves as a key document representing the pharmaceutical company's position on the product and is used as a reference document for national labels. Content from national labels may differ from the CCDS for different reasons including implementation of national authority requirements in the serving market and findings from local markets. In the current article, we discuss the process, challenges and key concepts in creating and maintaining CCDS documents for generic products. We highlight key parameters that are worthy of process improvement in generic products' CCDS updates. In addition, we argue that labelling harmonisation across multiple regions, especially safety section-related information, plays a key role in promoting end-user safety and would help communicate risks. We also strongly believe that the topic is worthy of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) consideration, and propose that this is the key area that requires standardisation and harmonisation.

The Unintended Consequences of Adverse Event Information on Medicines' Risks and Label Content.

Patients and prescribers need to be aware of adverse drug events to minimize the risk of their occurrence and the severity with which they appear. However, numerous studies show that being informed about adverse events can increase the possibility of suffering from them. Patients tend to overestimate the likelihood of experiencing the adverse events included in the label, and this can contribute to worsening the negative expectations which are at the root of the nocebo effect. In fact, patients can become anxious after reading the undesirable effects section of the leaflet and, in addition to suffering from the nocebo effect, might not take a drug they could benefit from due to the fear of experiencing adverse events. In addition, patients' attention can focus towards non-specific symptoms of daily living that can be misattributed to the drug and included in the labelling. This article proposes a number of suggestions to reduce the abovementioned unintended effects associated with labelling, namely, an increased focus on the excess risk of experiencing adverse events rather than crude incidence, using attribute framing to help patients to better understand the risk of experiencing adverse events, dividing the undesirable effect section of the leaflet into subsections according to the level of evidence supporting causal relationships and, finally, restricting the addition of non-specific adverse events that are also symptoms of daily living to only those where there is enough evidence to show they have been caused by the drug. More studies on how to minimize the nocebo effect induced by adverse event information should be performed, and these should be done in collaboration with health authorities, to reach a shared consensus on how to better present adverse event information in the label.

Perceptions of U.S. and Canadian Cannabis Package Warnings Among U.S. Adults.

BACKGROUND: Cannabis warning labels can communicate risks, but there is little research on warning perceptions and differences by product type. METHODS: In a 2019 online survey, 1,000 U.S. adults (500 cannabis users and 500 cannabis non-users who used tobacco) were randomly assigned to view no warning or one of four U.S. or Canadian warnings displayed on images of packaging for dried flower or edible cannabis. The warnings described cannabis risks related to psychosis, addiction, lack of FDA oversight, and impaired driving. We used linear regression to examine perceptions of warnings and product harm as a function of product type (dried or edible) and warning. We examined which warning participants selected as most effective for discouraging youth use and impaired driving. RESULTS: Participants found the addiction warning (cannabis users: B = -1.04, p < 0.001; cannabis non-users: B = 1.17, p < 0.001) and psychosis warning (users: B = -0.65, p < 0.05; non-users: B = -0.71, p < 0.05) less believable than the driving warning but indicated that they learned more from the psychosis warning than the driving warning (users: B = 0.88, p < 0.01; non-users (B = 1.60, p < 0.001). Participants viewing any warning considered smoking cannabis to be more harmful than those viewing no warning (all p < 0.05). The psychosis warning was most frequently selected as the best warning for discouraging youth use. CONCLUSIONS: Warnings have the potential to educate consumers and impact cannabis harm perceptions. Warnings have similar effects across product types, potentially eliminating the need for product type-specific warnings. The association of cannabis use with risk for psychosis, a topic addressed in Canadian warnings, could be a useful topic of focus in U.S. warnings.

The Effects of Alcohol Warning Labels on Population Alcohol Consumption: An Interrupted Time Series Analysis of Alcohol Sales in Yukon, Canada.

OBJECTIVE: There is limited evidence that alcohol warning labels (AWLs) affect population alcohol consumption. New evidence-informed AWLs were introduced in the sole government-run liquor store in Whitehorse, Yukon, that included a cancer warning (Ca), low-risk drinking guidelines (LRDGs) and standard drink (SD) messages. These temporarily replaced previous pregnancy warning labels. We test if the intervention was associated with reduced alcohol consumption. METHOD: An interrupted time series study was designed to evaluate the effects of the AWLs on consumption for 28 months before and 14 months after starting the intervention. Neighboring regions of Yukon and Northwest Territories served as control sites. About 300,000 labels were applied to 98% of alcohol containers sold in Whitehorse during the intervention. Multilevel regression analyses of per capita alcohol sales data for people age 15 years and older were performed to examine consumption levels in the intervention and control sites before, during, and after the AWLs were introduced. Models were adjusted for demographic and economic characteristics over time and region. RESULTS: Total per capita retail alcohol sales in Whitehorse decreased by 6.31% (t test p < .001) during the intervention. Per capita sales of labeled products decreased by 6.59% (t test p < .001), whereas sales of unlabeled products increased by 6.91% (t test p < .05). There was a still larger reduction occurring after the intervention when pregnancy warning labels were reintroduced (-9.97% and -10.29%, t test p < .001). CONCLUSIONS: Applying new AWLs was associated with reduced population alcohol consumption. The results are consistent with an accumulating impact of the addition of varying and highly visible labels with impactful messages.

IQOS point-of-sale marketing strategies in Israel: a pilot study.

BACKGROUND: Philip Morris International's IQOS ("I Quit Ordinary Smoking") device has increasingly penetrated the global tobacco market. In Israel, among the first countries with IQOS in its market, the IQOS device is sold in specialty stores and online; the heat sticks - HEETS - are sold at traditional retailers. Advertising restrictions in many contexts including Israel have shifted industry marketing efforts to point-of-sale (POS). Given the nuances of IQOS and HEETS product distribution and the importance of POS marketing, we conducted a pilot study of IQOS POS marketing strategies. METHODS: Data collectors assessed product offerings, pricing, promotional strategies, and placement in a sample of 15 IQOS retailers (10 convenience stores, 3 grocery stores, 2 tobacco shops) in three Israeli cities (Beer-Sheva, Haifa, Jerusalem). RESULTS: All retailers sold cigarettes; many carried other forms of tobacco (e.g., cigar products). Average price for a HEETS package was 30.2 Shekels (SD = 2.7); average price for the least expensive cigarette pack was 27.4 (SD = 1.5). HEETS were on average 9.5% more expensive than cigarettes. Posted ads were uncommon; rather, product displays were prominent. HEETS packages were often placed in a separate display box, at higher and more noticeable positions, and closer to consumers. Additionally, 11 retailers placed cigarettes and 10 placed HEETS near youth-oriented merchandise; 9 retailers placed cigarettes and HEETS, respectively, within 1 m of the floor. CONCLUSIONS: This study represents an initial step in assessing IQOS POS practices - critical in advancing the ability to facilitate related research and regulation of emerging tobacco products in Israel and more broadly.

Waterpipe tobacco package warning exposure's impact on risk perceptions and use among young adults in the USA: a longitudinal analysis of the population assessment of tobacco and health study.

BACKGROUND: Although Food and Drug Administration (FDA)-mandated waterpipe tobacco warnings were not required until August 2018, some waterpipe tobacco packaging (WTP) sold in the USA, contained warnings prior to this date. We examined the prevalence of WTP warning exposure and whether exposure influenced risk perceptions or use among young adult (aged 18-24 years) current waterpipe users. METHODS: We used data from waves 1 (2013-2014) and 2 (2014-2015) of the Population Assessment of Tobacco and Health Study, a nationally representative longitudinal study of US adults and youth. We conducted logistic regression analyses to identify factors associated with wave 1 warning exposure, and whether wave 1 WTP warning exposure predicted wave 2 relative risk perceptions and waterpipe use. RESULTS: More than one-third of our sample (35.9%, 95% CI 33.5 to 38.4) reported past-month WTP warning exposure. Exposure was higher among males (adjusted OR (AOR)=1.34, 95% CI 1.04 to 1.72), those who usually do not share the waterpipe (AOR=3.10, 95% CI 1.45 to 6.60), those who purchased waterpipe tobacco (AOR=1.73, 95% CI 1.28 to 2.34), and those with a regular brand (AOR=1.84, 95% CI 1.26 to 2.68). Those exposed to WTP warnings at wave 1 were more likely than those not exposed to perceive waterpipe tobacco to be as or more harmful than cigarettes at wave 2 (AOR=1.35, 95% CI 1.02 to 1.78). There was no association between wave 1 WTP exposure and wave 2 waterpipe use. CONCLUSIONS: More than one-third of US young adult current waterpipe users reported WTP warning exposure prior to FDA-mandated warning implementation. Findings suggest the mandated warning may result in high exposure among users; it will be critical to assess exposure's impact on risk perceptions and behaviour after FDA-mandated warnings are implemented.

The Influence of Health Numeracy and Health Warning Label Type on Smoking Myths and Quit-Related Reactions.

INTRODUCTION: Health numeracy helps individuals understand risk information, but limited data exist concerning numeracy's role in reactions to varying types of health warning labels (HWLs) for cigarettes. METHODS: A nationally representative online panel of adult current smokers received two exposures (1 week apart) to nine HWLs with either text-only or pictorial images with identical mandated text. Following the second exposure, participants (n = 594) rated their beliefs in smoking myths (eg, health-promoting behaviors can undo the risks of smoking) and how much the warnings made them want to quit smoking. Generalized estimating equation regression examined the relation of objective health numeracy and its interaction with HWL type to smoking-myth beliefs and quit-related reactions. RESULTS: Health numeracy was not significantly associated with smoking-myth beliefs; the interaction with HWL type was also nonsignificant. Adult smokers with lower health numeracy had higher quit-related reactions than those with higher numeracy following exposure to HWLs. The type of HWL significantly modified numeracy's associations with quit-related reactions; no significant association existed between text-only HWLs and quit-related reactions, whereas among those who viewed the pictorial warnings, lower numeracy was associated with greater quit-related reactions (ß = -.23; p < .001). CONCLUSIONS: Lower as compared to higher health numeracy was significantly associated with higher quit-related reactions to HWLs and especially with pictorial HWLs. Health numeracy and HWL type were not associated with the endorsement of smoking myths. The role of health numeracy in effectively communicating risks to smokers warrants thoughtful consideration in the development of tobacco HWLs. IMPLICATIONS: Health numeracy plays an important role in an individual's ability to understand and respond to health risks. Smokers with lower health numeracy had greater quit-related reactions to pictorial health warnings than those who viewed text-only warning labels. Development and testing of health warning labels should consider health numeracy to most effectively communicate risk to US smokers.

Reduced-Risk Warnings Versus the US FDA-Mandated Addiction Warning: The Effects of E-Cigarette Warning Variations on Health Risk Perceptions.

INTRODUCTION: Research on electronic cigarette (e-cigarette) warnings has primarily focused on addiction warnings, such as the one soon to be required by the Food and Drug Administration (FDA) in the United States. However, reduced-risk warnings, similar to the warnings recently proposed for smokeless tobacco products, remain a future possibility for e-cigarettes. Thus, this brief report compares e-cigarette health risk perceptions based on reduced-risk warnings and the FDA addiction risk warning, and considers whether these warnings differ in believability, ease of comprehension, and perceptions about the clarity of risk communication. METHODS: A quota sample of 672 smokers, e-cigarette users, dual users, and nonusers participated in this between-subjects experiment. Study participants were randomly assigned to one of three warning conditions, including the FDA-mandated addiction warning and two reduced-risk warnings. After exposure to the warning statement, participants responded to measures of health risk perceptions, believability, ease of comprehension, and perception about the clarity of risk communication. RESULTS: Results reveal that the addiction warning is perceived as more believable, easier to comprehend, and more clearly communicating the health risks of e-cigarettes use compared with the reduced-risk warnings. In addition, overall health risk perceptions and addiction risk perceptions based on the addiction warning are greater than health risk perceptions based on the reduced-risk warnings. In contrast, specific disease-related risk perceptions such as cancer, heart disease, lung disease, and harm to an unborn baby are greater for the reduced-risk warnings. CONCLUSIONS: This study provides a comparison of the forthcoming FDA-mandated e-cigarette addiction warning and reduced-risk warnings that have begun to be considered in the literature on a number of critical outcomes. IMPLICATIONS: This research provides a greater understanding of how variations of e-cigarette warnings, including addiction and reduced-risk warnings, are perceived by smokers, e-cigarette users, dual users, and nonusers. Specifically, findings show that overall health risk perceptions and addiction risk perceptions based on the addiction warning are greater than risk perceptions based on the reduced-risk warnings. In contrast, specific disease-related risk perceptions, such as cancer and heart disease, are greater for the reduced-risk warnings.

Innovations in counterfeiting tax stamps: a study of ultraviolet watermarks in a sample of discarded New York City packs.

OBJECTIVE: Document the use of ultraviolet watermark in counterfeit joint New York City/New York State cigarette tax stamps to assess the scale at which distributors of illegal cigarettes adapt to measures protecting the integrity of the system of tobacco tax collection. METHODS: In 2016, we collected 2357 empty discarded cigarette packs along a stratified random sample of block groups in New York City (n=114) and analysed 449 joint New York City/New York State tax stamps using long wave ultraviolet irradiation, light microscopy and taggant testers developed by the tax stamp manufacturer, Meyercord Revenue, to determine whether the tax stamps were counterfeit and how they differed from their genuine equivalent. FINDINGS: 23% (n=102) of the joint NYC/NYS tax stamps examined were counterfeit. Subsequent investigation revealed that almost two-thirds (n=58) of the counterfeit sample bore ultraviolet watermark that closely resembled genuine tax stamps in terms of fluorescence, watermark colour and wording. However, microscopic findings revealed that counterfeit tax stamps mismatched the genuine ultraviolet watermark in regards to font style and word orientation. CONCLUSION: Counterfeiters are using ultraviolet watermarks which makes it difficult to differentiate counterfeit joint New York City/New York State tax stamps from their genuine equivalent when UV irradiation is used as the sole screening tool. Innovations in counterfeiting technology may be the result of fluorescent ink being available for purchase in the mainstream market. Independent monitoring of trends in the illicit market for tobacco products is advised to keep apace of counterfeiting methods.

Are the Same Health Warnings Effective Across Different Countries? An Experimental Study in Seven Countries.

INTRODUCTION: More than 100 countries have implemented pictorial health warnings on cigarette packages. However, few studies have compared how consumers from different geographic and cultural contexts respond to health warning content. The current study compares perceptions of warnings among adult smokers and youth in seven countries, to examine the efficacy of different health warning themes and images. METHODS: Between 2010 and 2012, online and face-to-face surveys were conducted with ~500 adult smokers and ~500 youth (age 16-18) smokers and nonsmokers in each of Mexico, United States, China, Germany, India, Bangladesh, and Republic of Korea (total N = 8182). Respondents were randomized to view and rate sets of 5-7 health warnings (each set for a different health effect); each set included a text-only warning and various types (ie, themes) of pictorial warnings, including graphic health effects, "lived experience," symbolic images, and personal testimonials. Mixed-effects models were utilized to examine perceived effectiveness of warning themes, and between-country differences in responses. RESULTS: Overall, pictorial warnings were rated as more effective than text-only warnings (p < .001). Among pictorial themes, "graphic" health effects were rated as more effective than warnings depicting "lived experience" (p < .001) or "symbolic" images (p < .001). Pictorial warnings with personal testimonials were rated as more effective than the same images with didactic text (p < .001). While the magnitude of differences between warning themes varied across countries, the pattern of findings was generally consistent. CONCLUSIONS: The findings support the efficacy of graphic pictorial warnings across diverse geographic and cultural contexts, and support sharing health warning images across jurisdictions. IMPLICATIONS: Although over 100 countries have implemented pictorial health warnings on cigarette packages, there is little research on the most effective types of message content across geographic and cultural contexts. The current study examined perceived effectiveness of text and pictorial health warnings featuring different message content-graphic health effects, "lived experience," personal testimonials, and symbolic imagery-among more than 8000 adults and youth in Mexico, United States, China, Germany, India, Bangladesh, and Korea. Across countries, "graphic" pictorial messages were rated as most effective. Consistencies across countries in rating message content suggests there may be "globally effective" themes and styles for designing effective health warnings.

Informing drinkers: Can current UK alcohol labels be improved?

BACKGROUND: Alcohol labeling provides a relatively low-cost, population-level approach to providing information about alcohol's content and harms. METHOD: We conducted an online between-subjects experiment with two tasks to examine the impact of alcohol labels (n = 1884). In one task, participants were randomized to view one of four different unit labels (including labels currently used by the alcohol industry and novel labels which provide more information about how the number of units relates to recommended drinking guidelines). We assessed participants' accuracy of estimating weekly serving limits of alcohol. In a second task, participants were randomized to view one of eight health warnings (which varied according to message content, specificity, and framing). We assessed the motivation to quit after viewing the health warning. RESULTS: Accuracy of estimating weekly serving limits of alcohol was greater for participants who viewed novel unit labels compared to the industry standard labels. Motivation to drink less was higher amongst participants who had viewed both cancer and negatively framed messages, compared to mental health and positively framed messages. CONCLUSION: Existing unit labels used by the alcohol industry can be improved; the inclusion of unit information per serving and how these relate to low-risk drinking guidelines may be important for facilitating consumer understanding. Health warning labels should be included alongside units to provide consumers with information about the harms associated with alcohol and discourage riskier drinking behavior.

Commentary on 'Communicating Messages About Drinking': Using the 'Big Legal Guns' to Block Alcohol Health Warning Labels.

Like the tobacco industry, the alcohol industry, with the support of governments in alcohol exporting nations, is looking to international trade and investment law as a means to oppose health warning labels on alcohol. The threat of such litigation, let alone its commencement, has the potential to deter all but the most resolute governments from implementing health warning labeling.

Trajectories of Responses to Pictorial Cigarette Pack Warnings.

Background: Pictorial warnings on cigarette packs are a cost-effective policy-level intervention for smoking cessation; however, little research has examined changes in the impact of warnings over time, especially shortly following the first exposure to pictorial warnings. We sought to characterize the trajectories of responses to pictorial cigarette pack warnings soon after first exposure. Methods: Participants were 2149 adult smokers in North Carolina and California, United States. In 2014-2015, we randomized smokers to have pictorial (intervention) or text-only (control) warnings on their cigarette packs for 4 weeks. Weekly surveys assessed psychosocial and behavioral outcomes. Results: After 1 week, smokers in the intervention arm reported higher levels of most outcomes, compared with the control arm. Over subsequent weeks, smokers in both trial arms had decreases in thinking about the harms of smoking (ß = -0.046), positive (ß = -0.036), and negative (ß = -0.042) smoking reinforcement attitudes, and increases in quit intentions (ß = 0.070) and cigarette forgoing (ß = 0.137) (all p < .05). Only negative affective reactions decreased more in the intervention versus control condition (pinteraction < .01). Conclusions: The impact of pictorial cigarette pack warnings on emotions and cognitions may wane over time. In contrast, quit intentions and cigarette forgoing may continue to increase, at least during the initial period after introduction. Rotation of pictorial warnings may help prevent warning wear-out. Implications: Cigarette smoking is the leading cause of preventable morbidity and mortality and warnings on cigarette packs are a cost-effective policy-level intervention. Prior studies reporting on cigarette pack warning "wear out" have been limited by being short-term single-session experimental studies. Ours are the first study to experimentally examine the trajectories of several outcomes after first exposure and report that the impact of pictorial cigarette pack warnings on emotions and cognitions may wane over time while quit intentions and cigarette forgoing may continue to increase. Trials Registration: ClinicalTrials.gov identifier: NCT02247908; https://clinicaltrials.gov/ct2/show/NCT02247908.

Frequency and Content of Conversations About Pictorial Warnings on Cigarette Packs.

Introduction: Social interactions are a key mechanism through which health communication efforts, including pictorial cigarette pack warnings, may exert their effects. We sought to better understand social interactions elicited by pictorial cigarette pack warnings. Methods: A controlled trial randomly assigned US adult smokers (n = 2149) to have their cigarette packs labeled with pictorial or text-only warnings for 4 weeks. Smokers completed surveys during the baseline visit and each of the subsequent 4 weekly visits. Results: Smokers with pictorial warnings on their packs had more conversations throughout the trial compared to those with text-only warnings (8.2 conversations vs 5.0, p<.01). The highest number of conversations occurred during the first week. Smokers with pictorial warnings were more likely than those with text-only warnings to discuss the health effects of smoking, whether the warnings would make them want to quit and whether the warnings would make others want to quit (all p < .05). Smokers were more likely to describe pictorial warnings as scary, gross, or depressing and gloomy during conversations than text-only warnings (all p < .05). Conclusions: Pictorial warnings sparked more conversations about the warnings, the health effects of smoking, and quitting smoking than text-only warnings. These social interactions may extend the reach of pictorial warnings beyond the targeted smoker and may be one of the processes by which pictorial warnings have impact. Implications: Health communication can influence behavior by changing social interactions. Our trial characterized social interactions about pictorial cigarette pack warnings with a large longitudinal sample in a real-world setting. Understanding these conversations can inform the United States and other countries as they improve existing warnings and help tobacco control policy makers and health communication theorists understand how social interactions triggered by warnings affect smoking.

Does Adding Information on Toxic Constituents to Cigarette Pack Warnings Increase Smokers' Perceptions About the Health Risks of Smoking? A Longitudinal Study in Australia, Canada, Mexico, and the United States.

BACKGROUND: Health warning labels (HWLs) on cigarette packs in Australia, Canada, Mexico, and the United States include varying information about toxic cigarette smoke constituents and smoking-related health risks. HWL information changed more recently in Australia, Canada, and Mexico than in the United States. AIMS: To investigate whether smokers' knowledge of toxic constituents and perceived smoking-related risks increased after adding this information to HWLs and how knowledge of toxic constituents is associated with perceptions of smoking-related risks. METHODS: Data come from a longitudinal, online cohort of 4,621 adult smokers surveyed every 4 months from September 2012 (Wave 1) to January 2014 (Wave 5) in Australia, Canada, and Mexico, with the United States being surveyed from Waves 2 to 5. Generalized estimating equation models estimated the association between perceived smoking-related risk at follow-up and prior wave knowledge of toxic constituents, adjusting for attention to HWLs, sociodemographics, and smoking-related characteristics. RESULTS: Between 2012 and 2014, knowledge of toxic constituents increased in Australia, Canada, and Mexico ( p < .001), but not in the United States. Higher levels of both attention to HWLs and knowledge of toxic constituents were associated with a higher perceived risk of smoking-related conditions at follow-up across all countries except for the United States. CONCLUSIONS: Our results suggest that information about toxic constituents on prominent HWLs not only increases smoker's knowledge of toxic constituents, but that it may also reinforce the effects of HWL messages about specific, smoking-related health outcomes.

Over-Time Impacts of Pictorial Health Warning Labels and their Differences across Smoker Subgroups: Results from Adult Smokers in Canada and Australia.

Introduction: This study examines patterns of change in different smoker subgroups' responses to new pictorial health warning labels (HWLs) over the initial, two year post-implementation period in Canada, where HWLs include package inserts with cessation messages, and Australia, where "plain" packaging (i.e., prohibition of brand imagery) was also implemented. Methods: Data were collected from online consumer panels in Canada (nsmokers = 3153; nobservations = 5826) and Australia (nsmokers = 2699; nobservations = 5818) from September 2012 to September 2014, with approximately 1000 adult smokers surveyed in each country every four months, using replenishment to maintain sample size. Data were analyzed using generalized estimating equation models where main effects and interactions among time, country, and socio-demographic factors on HWL responses (i.e., attention to HWLs; cognitive and behavioral responses to HWLs) were examined. Results: Over time, attention to HWLs declined but cognitive and forgoing responses to HWLs increased, in both Canada and Australia. In both countries, compared to smokers with low income and/or education, smokers with high income and/or education showed an increase over time in attention and cognitive responses to HWLs (p < .05). In Australia only, compared to older smokers, younger smokers showed less decline over time in attention and greater increase in cognitive and forgoing responses to HWLs (p < .001). Conclusions: Novel HWL policies in Canada and Australia appear effective in staving off "wear out" over the first 2 years after implementation, particularly amongst smokers who are from higher SES groups and, in Australia, who are younger. Implications: Previous research shows that the effects of health warning label (HWL) on smokers decline over time, but no studies to date have evaluated whether trends differ across socio-demographic groups. This study suggests that innovative policy configurations that combine prominent pictorial HWLs with inserts (Canada) and with "plain" packaging (Australia) may delay wear out over the first 2 years after implementation. While this study found evidence for wear out in attention to HWLs, other HWL responses (cognitive responses, forgoing cigarettes) actually increased over time, with greater increases amongst smokers with higher income and/or education.

Depressive symptoms and responses to cigarette pack warning labels among Mexican smokers.

OBJECTIVE: We examine whether having depressive symptoms (DS) is associated with different responses to cigarette package health warning labels (HWLs) before and after the implementation of pictorial HWLs in Mexico. METHOD: We analyze data from adult smokers from Wave 4 and Wave 5 (n = 1,340) of the International Tobacco Control Policy Evaluation Project in Mexico. Seven Center for Epidemiological Studies Depression Scale (CES-D) items assessed DS, with scores ≥7 indicating elevated DS. Outcomes included: attention to HWLs, cognitive responses to HWLs, tobacco constituents awareness, putting off smoking due to HWLs, avoidance of HWLs, and awareness of telephone support for cessation (i.e., quitlines). Mixed effects models were used to assess main and interactive effects of DS and time (i.e., survey wave) on each outcome. RESULTS: All HWL responses increased over time, except putting off smoking. Statistically significant interactions were found between DS and time for models of tobacco constituents awareness (b = -0.36, SE = 0.15, p = .022), putting off smoking (OR = 0.41, 95% CI [0.25, 0.66]), avoidance of HWLs (OR = 1.84, 95% CI [1.03, 3.29]), and quitline awareness (OR = 0.35, 95% CI [0.21, 0.56]). Compared to smokers with low DS, smokers with elevated DS reported stronger HWL responses at baseline; however, HWL responses increased over time among smokers with low DS, whereas HWL responses showed little or no change among smokers with elevated DS. DISCUSSION: Population-level increases in HWL responses after pictorial HWLs were introduced in Mexico appeared mostly limited to smokers with low DS. In general, however, smokers with elevated DS reported equivalent or stronger HWL responses than smokers with low DS.

La comprensión de los pictogramas de peligro de productos químicos entre trabajadores del sector de limpieza / Comprehension of hazard pictograms of chemical products among cleaning workers

Objetivo: Valorar la comprensión de los pictogramas de peligro del Sistema Globalmente Armonizado (SGA) de las Naciones Unidas referente a la clasificación, envasado y etiquetado de sustancias y mezclas químicas en trabajadores del sector de la limpieza. Métodos: Se encuestó a una muestra de 118 trabajadores sobre su percepción de los pictogramas de riesgo químico del SGA. Se valoró la comprensibilidad de los pictogramas mediante el porcentaje de aciertos y su adecuación a los estándares de comprensión mínima de la Organización International de Normalización y del Instituto Nacional Estadounidense de Estándares. Se valoró la influencia de distintas variables en la capacidad de comprensión mediante un modelo de regresión logística. Resultados: Se observaron tres grupos de pictogramas estadísticamente diferenciados según su comprensibilidad: los pictogramas "toxicidad aguda" y "inflamable" fueron descritos correctamente por 94 y 95% de los trabajadores encuestados respectivamente, los pictogramas "toxicidad sistémica", "corrosivo", "atención", "medio ambiente" y "explosivo", presentaron frecuencias de acierto del 48 al 64%, mientras que los pictogramas "comburente" y "gases a presión" fueron correctamente interpretados por un 7% de los encuestados. Los factores pronósticos para una peor comprensión fueron no estar familiarizado con los pictogramas, no haber recibido formación en prevención sobre el uso de productos químicos, ser inmigrante y tener más de 54 años de edad. Conclusiones: Solo dos pictogramas superaron los estándares mínimos de comprensión en la muestra estudiada. La formación, un instrumento que ha probado su eficacia para mejorar la interpretación correcta de los símbolos de peligro, debería fomentarse, especialmente en aquellos colectivos con mayor dificultad de comprensión

Objective: To assess the comprehension among cleaning workers of the hazard pictograms as defined by the Globally Harmonized System (GHS) of the United Nations, concerning the classification, labeling and packaging of substances and mixture. Methods: A sample of 118 workers was surveyed on their perception of the GHS hazard pictograms. Comprehensibility was measured by the percentage of correct answers and the degree to which they reflected International Organization for Standardization and American National Standards Institute standards for minimum level of comprehension. The influence of different variables to predict comprehension capacity was assessed using a logistic regression model. Results: Three groups of pictograms could be distinguished which were statistically differentiated by their comprehensibility. Pictograms reflecting "acute toxicity" and "flammable", were described correctly by 94% and 95% of the surveyed population, respectively. For pictograms reflecting "systemic toxicity", "corrosive", "warning", "environment" and "explosive" the frequency of correct answers ranged from 48% to 64%, whereas those for pictograms "oxidizing" and "compressed gas" were interpreted correctly by only 7% of respondents. Prognostic factors for poor comprehension included: not being familiar with the pictograms, not having received training on safe use of chemical products, being an immigrant and being 54 years of age or older. Conclusions: Only two pictograms exceeded minimum standards for comprehension. Training, a tool proven to be effective to improve the correct interpretation of danger symbols, should be encouraged, especially in those groups with greater comprehension difficulties