Inconsistent excipient listings in DailyMed: implications for drug safety.

Excipients, or inactive ingredients, are a frequent cause of medication intolerance and allergy. Patients and clinicians concerned about medication allergies and sensitivities rely on the U.S. National Library of Medicine's DailyMed for accurate lists of excipients. Based on our anecdotal discovery of several examples of excipient omissions, we wished to examine the accuracy of DailyMed's listings more systematically in a sample of commonly prescribed medications. The objective of the study is to identify the frequency of inconsistency of excipient reporting within the DailyMed website. We performed a database audit of the Structured Product Labeling XML file provided by the drug manufacturer to the Food and Drug Administration and DailyMed for two randomly selected formulations of each of 50 commonly prescribed medications. For each of the 100 formulations, we compared the excipients listed in the "Description" to those in the "Ingredients and Appearance" sections in DailyMed. The Structured Product Labeling data file provided by the drug manufacturer contained internal inconsistencies of excipients in 39% of the formulations examined. Despite the use of Structured Product Labeling, the drug manufacturer's medication labels provided to the FDA and reported by DailyMed often contain conflicting information about inactive ingredients. Patients with allergies and excipient sensitivity should be aware of these discrepancies and consult multiple sections of the label to identify potential allergy-inducing inactive ingredients.

Evaluation and risk communication of the effects of alcohol exposure on disposable procedure masks and portable air purifiers in hospital environments.

Electret technology was widely used to prevent the airborne transmission of bioaerosols during the COVID-19 pandemic and improve the filtration efficiency of masks and high-efficiency particulate air (HEPA) filters. As alcohol disinfectants are widely used in medical and welfare institutions, concerns about alcohol exposure inactivating electret exist. However, comprehensive alcohol exposure tests have not been conducted on masks and HEPA filters distributed in Japan. Twenty-five types of masks and five types of HEPA filters were subjected to a discharging process according to ISO 16890 to quantitatively elucidate the resistance to alcohol exposure. Measurements of changes in filtration efficiency and pressure drop before and after discharge show that 17 masks (68%) and four HEPA filters (80%) exhibited a significant decrease in filtration efficiency, confirming their vulnerability to alcohol. In addition, a survey (n = 500 Japanese adults, including 30 healthcare professionals) revealed that ∼90% of the general public were unaware that alcohol exposure could degrade masks and air purifiers. Furthermore, 36% of the surveyed healthcare professionals had sprayed alcohol directly onto their masks. The effectiveness of user warnings through product labels and instructions was investigated from the perspective of ensuring the safety of patients and healthcare professionals. Results revealed that the best approach was to describe the extent and duration of the adverse effects caused by disregarding precautions. Increase in awareness of healthcare professionals and general public by authorities and manufacturers through guidelines and warning labels would reduce the risk of inhaling bioaerosols caused by unintentional electret inactivation.

US FDA's Dose Optimization Postmarketing Requirements and Commitments of Oncology Approvals and the Impact on Product Labels from 2010 to 2022: An Emerging Landscape from Traditional to Novel Therapies.

BACKGROUND: Dose optimization is a focal point of many US Food and Drug Administration (FDA) drug approvals. We sought to understand the impact of the FDA's Postmarketing Commitments/Postmarketing Requirements (PMCs/PMRs) on dose optimization and prescriber labeling for oncology drugs. METHODS: Publicly available information was aggregated for all FDA oncology drug approvals between January 1, 2010, and December 31, 2022. Study completion dates were compared to product labeling before and after PMC/PMR fulfillment dates to evaluate labeling changes associated with dose-related PMCs/PMRs. Data were analyzed individually (2010-2015 and 2016-2022) due to differences in available information. RESULTS: From 2010 to 2015, 14 of 42 (33.3%) new molecular entities (NMEs) had dose-related PMCs/PMRs, with 6 of 14 (42.9%) resulting in a relevant label change. From 2016 to 2022, of the 314 new or supplemental applications approved, 21 had dose-related PMCs/PMRs (6.7%), which trended upward over time; 71.4% of dose-related PMCs/PMRs were NMEs. Kinase inhibitors (KIs) and antibody/peptide drug conjugates (ADCs/PDCs) were the most affected drug classes. Ten of the 21 approvals with dose-related PMCs/PMRs fulfilled their dosing PMCs/PMRs, and 3 of the 10 (30%) had relevant label changes. CONCLUSION: Most dose-related PMRs/PMCs were issued for NMEs. Of these, KIs and ADCs/PDCs were highly represented, reflecting their novelty and greater uncertainty around their safety profile. PMC/PMR issuance broadly increased over time. With the implementation of the FDA's Project Optimus in 2021, it remains to be seen whether fewer dose-related PMCs/PMRs emerge in future due to enhanced dose optimization in the premarketing setting.

Combining Inserts With Warning Labels on Cigarette Packs to Promote Smoking Cessation: A 2-Week Randomized Trial.

BACKGROUND: Cigarette pack inserts with messages on cessation benefits and advice are a promising labeling policy that may help promote smoking cessation. PURPOSE: To assess insert effects, with and without accompanying pictorial health warning labels(HWLs), on hypothesized psychosocial and behavioral outcomes. METHODS: We conducted a 2 × 2 between-subject randomized trial (inserts with efficacy messages vs. no inserts; large pictorial HWLs vs. small text HWLs), with 367 adults who smoked at least 10 cigarettes a day. Participants received a 14-day supply of their preferred cigarettes with packs modified to reflect their experimental condition. Over 2 weeks, we surveyed participants approximately 4-5 times a day during their smoking sessions, querying feelings about smoking, level of worry about harms from smoking, self-efficacy to cut down on cigarettes, self-efficacy to quit, hopefulness about quitting, and motivation to quit. Each evening, participants reported their perceived susceptibility to smoking harms and, for the last 24 hr, their frequency of thinking about smoking harms and cessation benefits, conversations about smoking cessation or harms, and foregoing or stubbing out cigarettes before they finished smoking. Mixed-effects ordinal and logistic models were estimated to evaluate differences between groups. RESULTS: Participants whose packs included inserts were more likely than those whose packs did not include inserts to report foregoing or stubbing out of cigarettes (OR = 2.39, 95% CI = 1.36, 4.20). Otherwise, no statistically significant associations were found between labeling conditions and outcomes. CONCLUSIONS: This study provides some evidence, albeit limited, that pack inserts with efficacy messages can promote behaviors that predict smoking cessation attempts.

Cigarette pack inserts (small leaflets inside packs) with messages about quitting benefits and tips to quit may promote smoking cessation. We randomly assigned 367 adult smokers to one of four groups: control group with small health warning labels (HWLs) on the side of packs; inserts with cessation messages and small HWLs; large picture HWLs showing health effects from smoking; inserts and large picture HWLs. Participants received a 14-day supply of their preferred cigarettes in packs that reflected their assigned group. Over 2 weeks, we surveyed participants 4­5 times a day during times when they smoked, asking their feelings about smoking and smoking-related harms, confidence to reduce cigarettes and quit, hopefulness about quitting, and motivation to quit. Each evening, participants reported on the prior 24 hr: how often they thought about smoking harms and cessation benefits; conversations about smoking cessation or harms; and foregoing or stubbing out cigarettes before they finished smoking. People whose packs had inserts (with or without picture HWLs) were more likely than those whose packs did not include inserts (control group or picture HWLs only) to report foregoing or stubbing out of cigarettes. This study provides some evidence that inserts with cessation messages may promote smoking cessation.

Cigarette packaging, warnings, prices, and contraband: A discrete choice experiment among smokers in Ontario, Canada.

In Canada, despite substantial decline, tobacco use remains the leading risk factor responsible for mortality and morbidity. There is overwhelming evidence that higher tobacco taxes reduce tobacco use, even if high taxes create an incentive to avoid or evade tobacco taxes. Recently, in addition to taxes, plain and standardized packaging and printing a warning on each cigarette have been lauded to reduce tobacco use. In November 2019, Canada became the country with the most comprehensive cigarette packaging regulations; and in June 2022, Canada proposed to print health warnings on individual cigarettes, the first jurisdiction to ever do so. The regulations came into force on August 1, 2023, and are being implemented through a stepwise approach. Our objective was to examine the effects of plain and standardized packaging, warning on cigarettes, price, and the availability of illicit cigarettes on intention to purchase and risk perceptions. We conducted a discrete choice experiment, and examined heterogeneity in preferences using latent class models among smokers in Ontario, Canada. We found that using latent class analyses was essential in quantifying preferences for attributes of cigarettes and cigarette packs. First, nearly half of smokers stated a preference for cheaper illicit cigarettes in a branded pack without any health warnings, regardless of the licit cigarette alternatives. For about 20% of respondents, plain packaging and especially warning on cigarette sticks decreased the probability of stating a purchasing preference for these alternatives. Third, about a third of respondents chose competing alternatives with mostly one attribute in mind, price. Lastly, none of the products and attributes seem to have significantly influenced risk perception. Our findings attest to the importance of prices and taxes, to the potential of warnings on cigarette sticks to control tobacco use, and indicate that efforts to restrict the availability of illicit cigarettes may yield substantial benefits.

Safety culture and perception of warning signs of chemical hazards among hospital cleaning workers: a cross-sectional study.

BACKGROUND: Due to the type of activities and the long-term exposure to chemicals, hospital cleaning workers require the necessary knowledge about the chemicals used and proper safety culture. This study aimed to evaluate the safety culture and perception of hospital cleaning workers' warning signs of chemical hazards. METHODS: This cross-sectional study was conducted in 2022 with the participation of 68 cleaning workers with the mean age ± (SD) and work experience ± (SD) of 36.19 ± (7.619) and 9.21 ± (5.462), respectively, in four selected Tehran hospitals in Iran. After ensuring the confidentiality of the received information and completing the demographic information checklist, each participant completed Global Harmonization System (GHS) sign perception and the safety culture questionnaires in this survey. Data were analyzed using regression and Pearson correlation tests. RESULTS: This study showed that the participant's correct perception in nine cases (81.8%) of presented GHS signs was lower than the ANSI Z535.3 standard. Among the investigated signs, "Flammable substances" and "Harmful to the environment" signs had the highest, and "Skin irritant" signs had the lowest correct perception. In addition, it was found that 55 people (80.9%) had an overall positive attitude toward the safety culture. The levels of "Work environment" (83.8%) and "Information exchange" (76.5%) had the highest and lowest positive scores for safety culture. Furthermore, there is a direct and significant relationship between the overall score of safety culture and the overall perception of the symptoms of GHS (CC = 0.313, P = 0.009). CONCLUSION: According to the obtained results, it is recommended to take the necessary measures to increase the employees' perception of the signs of chemical substances and improve their safety culture.

Socioeconomic and Demographic Factors Associated with the Influence of the Food Traffic Light Labeling on the Decision of the Adult Population of Ecuador to Purchase Processed Foods, 2018.

To determine the socioeconomic and demographic factors associated with the influence of the nutritional traffic light (NTL) on the decision to purchase processed foods using information from the National Health and Nutrition Survey (ENSANUT) 2018 of Ecuador, a cross-sectional and analytical study based on a secondary analysis of the information from the ENSANUT 2018 was performed. We collected data from 25,932 participants 18 years of age or older who knew or had seen the NTL, and for whom complete information on the variables of interest for the study was available. The "Influence of the NTL on the purchase decision of processed foods" was the outcome variable of the study. Generalized linear models of the Poisson family, with log link, were used to assess the association between socioeconomic factors and outcome, using crude (PR) and adjusted (aPR) prevalence ratios, with 95% confidence intervals (CI) and a p-value < 0.05. Participants who understood the NTL (aPR: 2.49; 95% CI: 2.19-2.83), with a higher educational level (aPR: 1.33; 95% CI: 1.09-1.61), women (aPR 1.06; 95% CI: 1.01-1.10), and who had a partner (aPR 1.09; 95% CI: 1.04-1.14) were more likely to be influenced by the NTL when deciding to purchase processed foods, compared to people who did not understand the NTL, who had no educational level or who only attended a literacy center, were men, and those without a partner. The inhabitants of the coastal region (aPR: 0.92; 95% CI: 0.88-0.97), the Amazon (aPR 0.93; 95% CI: 0.88-0.98), and the insular region (aPR 0.76; 95% CI: 0.68-0.84) had few probabilities of being influenced by the NTL in the decision to purchase processed foods, in comparison with the residents of the highlands. Similarly, compared to non-poor people, poor people had a lower probability of being influenced by the NTL (aPR 0.89; 95% CI: 0.82-0.97). Factors associated with the influence of NTL on the decision to purchase processed foods were identified. It is recommended to reformulate and focus awareness strategies for using the NTL to purchase processed foods by taking into account the associated factors.

Approaches to the Assessment of Clinical Benefit of Treatments for Conditions That Have Heterogeneous Symptoms and Impacts: Potential Applications in Rare Disease.

OBJECTIVES: Evaluating the clinical benefit of interventions for conditions with heterogeneous symptom and impact presentations is challenging. The same condition can present differently across and within individuals over time. This occurs frequently in rare diseases. The purpose of this review was to identify (1) assessment approaches used in clinical trials to address heterogeneous manifestations that could be relevant in rare disease research and (2) US Food and Drug Administration (FDA)-approved labeling claims that used these approaches. METHODS: A targeted literature review was conducted examining peer-reviewed publications and FDA-approved labeling claims from January 2002 to July 2020, focusing on claims incorporating clinical outcome assessments. Approaches were then assessed for their potential application in rare diseases. RESULTS: A total of 6 assessment approaches were identified: composite or other multicomponent endpoints, multidomain responder index, most bothersome symptom (MBS), goal attainment scaling, sliding dichotomy, and adequate relief. A total of 59 FDA-approved labeling claims associated with these approaches were identified: composite or other multicomponent endpoints (n=49), MBS (n=9), and adequate relief (n=1). A total of 10 FDA-approved labeling claims, all using multicomponent endpoints, were identified for rare diseases. CONCLUSIONS: Multicomponent, MBS, and adequate relief have been included in FDA-approved labeling claims. Multicomponent endpoints, including composite endpoints, were the most frequent way to address heterogeneous manifestations of both common and rare diseases. MBS may be acceptable to regulators, whereas multidomain responder index is unlikely to be. The goal attainment scaling and adequate relief approaches may have potential utility in rare disease trials, assuming the theoretical and statistical challenges inherent in each approach are managed.

Safety and risks of CBD oils purchased online: unveiling uncertain quality and vague health claims.

Introduction: The unmet need for highly effective, naturally derived products with minimal side effects results in the over-popularity of ever-newer medicinal plants. In the middle of 2010, products containing cannabidiol (CBD), one of the special metabolites of Cannabis sativa, started to gain popularity. For consumers and healthcare providers alike, the legal context surrounding the marketing of CBD products is not entirely clear, and the safety of using some products is in doubt. Companies in the online medicinal product market profit from the confusion around CBD oils. Methods: In our study, we employed a complex method known as risk-based safety mapping of the online pharmaceutical market, which included health claim content analysis of online stores, test purchases, and labeling and quantitative analysis of the CBD content. Results: There were discovered 16 online retailers selling an average of 2-7 goods and CBD oils with a concentration of 3%-5% (30-50 mg/mL) CBD. The majority (n/N = 10/16, 62.5%) displayed potential health-related benefits indirectly on their website, and in the case of one web shop (n/N = 1/16, 6.3%), we detected COVID-19-related use. Altogether, 30 types of purported "indications" were collected. A total of 12 CBD oil products were test-purchased from online retailers in December 2020. Upon evaluating the packaging and product information, we noticed that three products (n/N = 3/12, 25%) lacked instructions on use, hence increasing the risk of inappropriate application and dosing. The cannabidiol content was quantified using UHPLC. The measured CBD concentrations of the products ranged from 19.58 mg/mL to 54.09 mg/mL (mean 35.51 mg/mL, median 30.63 mg/mL, and SD ± 12.57 mg/mL). One (8.33%) product was underlabeled, five (41.67%) were over-labeled, and only every second product (50%) was appropriately labeled based on the quantitative assessment of CBD concentration. Discussion: Further research and quality control are necessary to establish the regulatory context of the usage and classification of CBD and other cannabinoids in nonmedicinal products (e.g., food supplements), as authorities and policymakers worldwide struggle with the uncertainties surrounding CBD products.

Market survey of disposable e-cigarette nicotine content and e-liquid volume.

Inaccurate labels on some e-cigarette products have prompted calls for routine testing to monitor product label integrity. The objective of this study was to compare label statements of commercial disposable/non-chargeable e-cigarette products for nicotine concentration and e-liquid volume with analytically verified levels. Commercial e-cigarette samples were analyzed for nicotine concentration (N = 51), e-liquid volume and total nicotine content (N = 39). Twenty-three of the 51 samples analyzed for nicotine deviated from their label statements by more than ± 10%. Deviations ranged from -50.1% to + 13.9%. Thirty of the 39 samples analyzed for e-liquid volume deviated from their label statements by more than ± 10%. Deviations ranged from -62.1% to + 13.3%. Only one brand listed total nicotine on the label. In thirty-one of the 39 samples, calculated total nicotine amount in e-liquid deviated from the amounts calculated from the label metrics by more than ± 10%. Deviations ranged from -66.8% to -1.43%. These findings underscore the need for regulatory enforcement of manufacturing quality control and product labeling practices to optimize the harm reduction potential and consumer experience associated with the use of e-cigarette products.

Progress and challenges in tobacco control policies in Mexico, 2003-2017: an approach using the Tobacco Control Scale.

The study aims to assess the implementation of tobacco control policies in Mexico from 2003 through 2017 using the Tobacco Control Scale (TCS). The TCS is a research tool widely used in the European region. It facilitates assessment of tobacco control policy implementation based on six cost-effective interventions: tobacco taxes, smoke-free policies, advertising bans, public spending on the information campaign, health warnings, and smoking cessation treatment, reflecting results in a total score between 0 and 100. From 2003 through 2017, Mexico's total score improved from 24/100 to 55/100, with substantial progress in raising tobacco taxes, 11 subnational smoke-free laws, and with placement on cigarette packs of large health warnings with pictograms. Progress in tobacco control policies implemented in this period corresponds with a decrease in smoking prevalence across Mexico. This tool is useful for monitoring tobacco policy implementation in low- and middle-income countries and be used for advocacy purposes to enforce and improve tobacco control legislation.

A Narrative Review of the Efficacy and Design of Safety Labels on Tobacco Products to Promote the Use of Safety Labels on Alcohol Products in Canada.

Alcohol is consumed by approximately three-quarters of Canadians. Alcohol causes acquired liver disease, increases the risk of cancer, has detrimental effects on mental health, and leads to adverse pregnancy outcomes. Alcohol-related morbidity and mortality are high, and urgent public health measures are warranted to prevent and control these. Tobacco safety labels have been shown in numerous studies to reduce tobacco consumption. Much can be learned from the design of tobacco safety labels in creating promising alcohol safety labels that can possibly help reduce alcohol consumption. The aim of this paper is to review the efficacy of tobacco safety labels in reducing tobacco consumption and the design of tobacco safety labels and to propose a promising design for alcohol safety labels based on our findings. English peer-reviewed papers published in western countries since 2000 were searched on PubMed and Google Scholar. Keywords and synonyms were used to search pertinent papers, which were subsequently screened by title and abstract and fully reviewed if relevant. Findings from studies comparing designs of safety labels on alcohol and tobacco products are similar. Graphics, higher emotion content, and greater size are associated with greater attention, awareness, negative emotions, intention to quit, and reduction in consumption. Mixed results are found for testimonials containing safety labels on tobacco products. It is unclear whether testimonials on alcohol safety labels reduce alcohol consumption or not. Safety labels with specific information, such as tobacco-related costs and alcohol-related cancer risks, are more effective in reducing tobacco consumption. In conclusion, preliminary alcohol safety labels show promise. Large safety labels with graphics and high emotional content appear to be most effective and may reduce alcohol consumption.

Suplemento alimentar de vitamina C: fiscalização durante o período de adequação à nova legislação / Vitamin C dietary supplement: inspection during adequacy period of new legislation

Os suplementos à base de vitamina C são amplamente consumidos pela população, evidenciando a importância da fiscalização desses produtos. Em julho de 2018, a ANVISA (Agência Nacional de Vigilância Sanitária) publicou as novas regulamentações sobre suplementos alimentares, estabelecendo-se o prazo de 60 meses para as empresas se adequarem a essas normas. O presente trabalho teve como objetivo determinar os teores de vitamina C, comparar os valores analisados com os declarados na informação nutricional e avaliar os dizeres de rotulagem em produtos à base dessa vitamina. Os teores de vitamina C foram determinados por titulação potencio métrica e as análises de rotulagem foram realizadas com base nas legislações da ANVISA em doze amostras de suplementos colhidos pelas Vigilâncias Sanitárias do Estado de São Paulo. Os teores de vitamina C avaliados estavam de acordo com os declarados na informação nutricional do rótulo, com exceção de uma amostra que apresentou teor abaixo do valor declarado. Em relação aos dizeres de rotulagem, sete amostras (58%) apresentaram um ou mais itens em desacordo com a legislação, mostrando a necessidade de monitoramento constante desse tipo de produto. O trabalho representa um estudo preliminar de avaliação dos suplementos no período de adequação às novas regulamentações (AU).

Vitamin C-based supplements are widely consumed by the population, highlighting the importance of monitoring these products. In July 2018, the ANVISA (National Health Surveillance Agency) published new regulations for dietary supplements,setting a 60 months deadline for companies to comply with these standards.The objective of the present work was to evaluate the contents of vitamin C, and compare the analyzed/real values with those reported on the nutrition facts label, and to evaluate the labeling of vitamin supplements. Vitamin C contents were determined by potentiometric titration, and labeling analysis were performed based on ANVISA legislation in twelve samples of supplements collected by the Sanitary Surveillance of the State of São Paulo.The contents of vitamin C were in accordance with those declared in the nutritional information on the label, with the exception of one sample that presented content below the declared value. Regarding the labeling analysis, seven samples (58%) presented one or more items in disagreement with the legislation, showing the need for constant monitoring of this type of product.The work represents a preliminary study to evaluate the supplements in the adequacy period of new regulations (AU).

La trazabilidad en el sistema logístico de medicamentos en Cuba y el uso de las tecnologías de auto-identificación / Traceability in the logistics system of medicines in Cuba, use of auto-identification

La trazabilidad es la capacidad para rastrear la historia, aplicación o ubicación de un objeto bajo consideración. En el ámbito farmacéutico, el rastreo y seguimiento de los medicamentos, incluyendo las vacunas y otros medicamentos biológicos, a lo largo de la cadena de suministro constituye un requisito obligatorio establecido por las autoridades sanitarias a nivel internacional, que se exige en mayor o menor magnitud en las reglamentaciones vigentes. En este artículo se analiza el sistema de codificación y clasificación en el sector de la salud y su estado actual en la cadena de suministro de medicamentos de Cuba. Se presenta un procedimiento para la implementación de las tecnologías de auto-identificación e intercambio electrónico de datos, mediante el uso de GS1 en el sistema de codificación y clasificación empleado en el sector de salud, que permita la trazabilidad en toda la cadena de suministro en Cuba(AU)

Traceability is the capability to track the history, application or location of an object under consideration. In the pharmaceutical field, the tracking and monitoring of medicines, including vaccines and other biological medicines, along the supply chain constitutes a mandatory requirement established by the sanitary authorities at an international level, which is demanded to a greater or lesser extent in the regulations in force. This research was carried out involving different links in the drug supply chain in Cuba, ranging from drug suppliers, drug distribution company, to healthcare centers and pharmacies. An analysis is carried out on the current coding and classification system, detecting the ineffectiveness of the identification of the drugs as the main deficiency. A procedure is proposed for the implementation of the auto-identification and electronic data interchange technologies using GS1 in the coding and classification system used in the health sector that allows traceability throughout the supply chain in Cuba(AU)

Microscopic examination of dog chews: correlation of histological findings to product labeling.

The purpose of this study was to use routine morphologic-based staining techniques to examine the histology of commercially labeled rawhide and rawhide-free dog chew products and compare the results to the product labeling. Ten dog chew products were examined by light microscopy using hematoxylin and eosin and Masson's trichrome stains. The products were labeled by the manufacturer as rawhide, beef hide, beef chew/rawhide free, and rawhide free. Four of the products were composed of two separate materials, a main chew roll and a second substance (filler) which was coated on or between the layers of the main chew roll. These materials were processed independently. Microscopically, a variety of tissues and materials were identified including collagen, skeletal muscle, fat, plant material, and starch. The products and their fillers were separated into four distinct groups based on microscopic appearance. The components identified in eight of the products appeared consistent with the product labeling. Two products labeled as rawhide free appeared similar to the dermis and this was inconsistent with product labeling. Masson's trichrome stain was not helpful in distinguishing tissue types in the tested products and this may have been due to the heat processing the products underwent during manufacturing. Bacteria and/or fungi were identified by microscopy in the H&E stained sections in four rawhide-free products.

Laboratory chemical waste: hazard classification by GHS and transport risk / Resíduos químicos laboratoriais: classificação de perigo pelo GHS e risco no transporte

ABSTRACT OBJECTIVES: To identify and evaluate, based on the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) and the legislation of the Agência Nacional de Transportes Terrestres (ANTT - National Agency for Terrestrial Transport), the hazards arising from chemical waste generated in research laboratories in the health area. METHODS: Chemical residues generated in two medical research laboratories of the Faculdade de Medicina da Universidade de São Paulo were inventoried, from November 2017 to April 2019, and classified according to the GHS (hazard statements) and the ANTT transport legislation (risk classes), to determine the dangers coming from the respective substances and mixtures. RESULTS: In total, we identified 40 substances or mixtures with classification by the GHS indicating 36 hazard statements, 27 of which related to human health. According to the legislation established by ANTT, we found 16 cases of hazard associated with flammability, 15 cases related to toxicity and 12 cases related to corrosivity. CONCLUSIONS: Chemical residues generated in the laboratories studied are diversified in terms of their hazard characteristics, implying the possibility of exposure to severe risks to workers, students and the environment. The correct identification of these residues is a primary factor for reducing exposure to risks.

RESUMO OBJETIVOS: Identificar e avaliar, com base no Sistema Globalmente Harmonizado de Classificação e Rotulagem de Produtos Químicos (GHS) e na legislação da Agência Nacional de Transportes Terrestres (ANTT), os perigos provenientes dos resíduos químicos gerados em laboratórios de pesquisa na área de saúde. MÉTODOS: Resíduos químicos gerados em dois Laboratórios de Investigação Médica da Faculdade de Medicina da Universidade de São Paulo foram inventariados, no período de novembro de 2017 a abril de 2019, e classificados conforme o GHS (frases de perigo) e a legislação de transportes da ANTT (classes de risco), para determinação dos perigos provenientes das respectivas substâncias e misturas. RESULTADOS: No total, foram identificadas 40 substâncias ou misturas, cuja classificação pelo GHS indicou 36 frases de perigo, sendo 27 relacionadas à saúde humana. De acordo com a legislação estabelecida pela ANTT, foram encontrados 16 casos de periculosidade associada à inflamabilidade, 15 casos relacionados à toxicidade e 12 casos relativos à corrosividade. CONCLUSÕES: Resíduos químicos gerados nos laboratórios estudados são diversificados quanto a suas características de periculosidade, implicando a possibilidade de exposição a riscos severos aos trabalhadores, aos estudantes e ao ambiente. A correta identificação desses resíduos é fator primordial para diminuição da exposição aos riscos.

Redistributing deaths by ill-defined and unspecified causes on cancer mortality in Brazil

ABSTRACT OBJECTIVE to discuss the impact four different redistribution strategies have on the quantitative and temporal trends of cancer mortality assessment in Brazil. METHODOLOGY This study used anonymized and georeferenced data provided by the Brazilian Ministry of Health (BMoH). Four different approaches were used to conduct the redistribution of ill-defined deaths and garbage codes. Age-standardized mortality rates used the world population as reference. Prais-Winsten autoregression allowed the calculation of region, sex, and cancer type trends. RESULTS Death rates increased considerably in all regions after redistribution. Overall, Elisabeth B. França's and the World Health Organization methods had a milder impact on trends and rate magnitudes when compared to the Global Burden of Disease (GBD) 2010 method. This study also observed that, when the BMoH dealt with the problem of redistributing ill-defined deaths, results were similar to those obtained by the GBD method. The redistribution methods also influenced the assessment of trends; however, differences were less pronounced. CONCLUSIONS Since developing a comparative gold standard is impossible, matching global techniques to local realities may be an alternative for methodological selection. In our study, the compatibility of the findings suggests how valid the GBD method is to the Brazilian context. However, caution is needed. Future studies should assess the impact of these methods as applied to the redistribution of deaths to type-specific neoplasms.

Parabens in stretch mark creams: A source of exposure in pregnant and lactating women.

Parabens are widely used as antimicrobial preservatives in personal care products (PCPs). Stretch mark cream is widely used by pregnant and lactating women for the treatment of striae gravidarum. This can be a potential source of paraben exposure, not only to pregnant/lactating women but also to fetuses/newborns. Little is known, however, with regard to the occurrence of parabens in stretch mark creams. In this study, we analyzed eight parabens and their metabolites in 31 popular stretch mark creams originated from various countries including China. The concentrations of Σparaben (sum of eight parabens/metabolites) ranged from 0.007 to 1630 µg/g, with mean and median values of 453 and 273 µg/g, respectively. Methyl- and propyl-parabens accounted for >95% of Σparaben concentrations. We examined the measured paraben concentrations against ingredients listed on the product labels. Parabens were listed as ingredients in those creams that contained concentrations >100 µg/g except for four samples with such high concentrations. Six cream samples that were labeled 'paraben-free' contained trace levels (0.007-9.92 µg/g) of these preservatives. Mean dermal ∑paraben exposure dose from the use of stretch mark creams (30.6 µg/kg bw/day) was well below the current acceptable daily intake value (5 mg/kg bw/day). In comparison to diet and indoor dust ingestion pathways, paraben-laden stretch mark cream may be a major source of paraben exposure in pregnant and lactating women. This study provides information on parabens and other preservatives in stretch mark creams and measures to reduce exposures during pregnancy and lactation.

Comparación de tres modelos de etiquetado nutricional frontal de productos industrializados en Perú, 2019 / Comparison of Three Types of Nutrition Label on Processed Food Packages in Peru, 2019

Resumen Antecedentes: el etiquetado nutricional frontal es una herramienta para orientar la elección del con sumidor hacia una dieta equilibrada y sana. Objetivo: conocer el modelo de etiquetado nutricional frontal que más influye en la identificación de calorías y nutrientes críticos de productos industria lizados en adultos de Lima, Perú. Materiales y métodos: estudio cuasiexperimental-transversal en el que participaron 384 adultos de ambos sexos distribuidos en cuatro grupos equitativos: sin modelo de etiquetado nutricional, Guía Diaria de Alimentación, etiquetado de advertencia octogonal y Guía Diaria de Alimentación-semáforo. A cada participante se le aplicó un cuestionario con 10 figuras de empaques con el modelo de etiquetado, según el grupo al que correspondían, y 10 preguntas, con un puntaje total de 0 al 20, según el número de respuestas positivas en la identificación de calorías y nutrientes críticos. Resultados: los mayores puntajes totales fueron para los grupos Guía Diaria de Alimentación-semáforo (12,1±3,9) y Guía Diaria de Alimentación (12,1±3,7), con diferencias significativas respecto a los otros dos grupos. También se presentaron diferencias en los puntajes de la identificación de calorías, grasas saturadas y grasa total; los valores más altos fueron para los dos grupos señalados (p<0,05). No se observaron diferencias en la identificación de azúcar y sodio. Conclusiones: los modelos Guía Diaria de Alimentación y Guía Diaria de Alimentación-semáforo son los que más influyen en la identificación de calorías y nutrientes críticos.

Abstract Background: A front-of-package nutrition label is a tool to help guide food selection towards a balanced and healthy diet. Objective: To understand the model of front-of-package nutrition label that most influences the understanding of calories and important nutrients in processed food products in adult participants in Lima, Peru. Materials and Methods: A quasi-experimental cross-sectional study with 384 participant adults of both sexes. Participants were distributed into four equal groups: no nutritional labeling; daily food guide; stop sign warning labeling; and daily food guide with a traffic light symbol. Each participant was given a questionnaire with 10 pictures of food packaging with the labeling model that corresponded to their randomized group, along with 10 additional questions, for a total of 20 possible questionnaire points. Points were given for correct answers to the 20 questions on the questionnaire, such as identifying correctly the number of calories and/or critical nutrients. Results: The highest total scores were for the daily food guide-traffic light group (12.1 ± 3.9) and daily food guide group (12.1 ± 3.7), with significant differences with respect to the other two groups. There were also differences in the scores of the identification of calories, saturated fat, and total fat; the highest values were for the same two groups indicated above (p <0.05). No differences in food labels were found for the identification of sugars or sodium. Conclusions: The daily food guide and daily food guide-traffic light models most influence the identification of calories and critical nutrients.

Cigarette Packs With URLs Leading to Tobacco Company Websites: Content Analysis.

BACKGROUND: Tobacco companies include on the packaging of their products URLs directing consumers to websites that contain protobacco messages. Online media tend to be underregulated and provide the industry with an opportunity to present users with protobacco communication. OBJECTIVE: The objective of our study was to document the content of websites that were advertised on tobacco packs in 14 low- and middle-income countries. METHODS: We purchased tobacco packs from 14 low- and middle-income countries in 2013 and examined them for the presence of URLs. We visited unique URLs on multiple occasions between October 1, 2016 and August 9, 2017. We developed a coding checklist and used it to conduct a content analysis of active corporate websites to identify types of protobacco communication. The coding checklist included the presence of regulatory controls and warnings, engagement strategies, marketing appeals (eg, description of product popularity, luxury/quality, taste), corporate social responsibility programs, and image management. We coded brand websites separately and also described social media and other website types. RESULTS: We identified 89 unique URLs, of which 54 were active during the search period. We assessed 26 corporate websites, 21 brand websites, 2 nontobacco websites, and 5 social media pages. We excluded 2 corporate websites and 14 brand websites due to limited accessible content or incomplete content. Corporate social responsibility was discussed on all corporate websites, and marketing appeals were also common. Corporate websites were also more likely to include more nonspecific (12/24, 50%) than specific (7/24, 29%) health warnings. Promotions (6/7, 86%) and sociability appeals (3/7, 43%) were common on brand websites. The small number of social media webpages in our sample used gendered marketing. CONCLUSIONS: URLs appearing on tobacco packs direct consumers to websites where users are exposed to marketing that highlights the "positive" contributions of tobacco companies on corporate websites, and extensive promotions and marketing appeals on brand websites and social media pages. It is essential that marketing regulations become more comprehensive and ban all protobacco communication, a policy that is in line with articles 5.3 and 13 of the World Health Organization Framework Convention on Tobacco Control. For countries that already ban internet tobacco advertising, enforcement efforts should be strengthened. Tobacco companies' use of URLs on packs may also be compelling for plain packaging advocacy, where all branding is removed from the pack and large graphic health warning labels are the only communication on the tobacco packaging. Future research should consider including tobacco websites in marketing surveillance.