Impacto na qualidade de antissépticos e desinfetantes com álcool 70% (p/p) utilizados no enfrentamento da pandemia provocada pelo SARS-CoV-2 / Impacts on the quality of antiseptic and disinfectant products with 70% alcohol (w/w) used in the SARS-CoV-2 pandemic

Formulações contendo álcool etílico 70% (p/p) podem ser classificadas como cosméticos, medicamentos ou saneantes, dependendo da apresentação e local de uso. Foram largamente empregadas como antisséptico na forma líquida e gel no combate à pandemia provocada pelo SARS-CoV-2. O presente estudo teve como objetivo avaliar a qualidade de 60 produtos em relação ao teor e rotulagem, destinados à higienização das mãos, superfícies e de uso hospitalar comercializadas em São Paulo. Realizou-se a avaliação do teor de álcool etílico por determinação direta em densímetro digital e comparação das informações da rotulagem com as da legislação de referência e com o rótulo aprovado pela Agência Nacional de Vigilância Sanitária (ANVISA). Os resultados demonstraram que 48,3% das amostras apresentaram resultados inferiores aos limites regulatórios e às concentrações descritas no rótulo do produto para o teor de álcool etílico. Além disso, 5% apresentaram prazo de validade informado no rótulo acima de 180 dias, em desacordo com a RDC 350/20. Os níveis de insatisfatoriedade encontrados neste estudo indicam a necessidade de monitoramento da qualidade dos produtos disponíveis no mercado brasileiro com o propósito de apoiar as autoridades sanitárias nas atividades de fiscalização. (AU)

Formulations containing 70% ethyl alcohol (w/w) can be classified as cosmetics, medicines, or sanitizers depending on the presentation and place of use. These formulations were widely used as an antiseptic in the fight against the SARS-CoV-2 pandemic, available in both liquid and gel forms. The present study aimed to assess the quality of 60 products, intended for hand and surface hygiene and hospital use, sold in São Paulo. The ethyl alcohol content was evaluated by direct determination using a digital densimeter, and the labeling information was compared with the reference legislation and the label approved by ANVISA (Brazil's National Health Surveillance Agency). The results showed that 48.3% of the products had ethyl alcohol content below the regulatory limits and concentrations specified on the product label. Additionally, 5% of the products had an expiration date on the label that exceeded 180 days, contrary to RDC 350/20 regulations. The levels of unsatisfactory products found in this study indicate the need for continuous monitoring of the quality of products available in the Brazilian market. Such monitoring is crucial to support health authorities in their inspection activities and ensure the efficacy and safety of antiseptic and disinfectant products used in the context of public health. (AU)

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).

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.

Research and Thinking of International Coordination Documents for Medical Device Labeling / 中国医疗器械杂志

OBJECTIVE@#To further improve the regulation of medical device Introduction for Use (IFU) and improve the quality of medical device Introduction for Use (IFU).@*METHODS@#Summarize domestic regulatory experience and deficiencies through literature research, and introduce the international experience gathered from the IMDRF coordination document Principles of Labelling for Medical Devices and IVD Medical Devices.@*RESULTS@#The IMDRF international coordination document categorizes ten chapters to define and summarize the basic principles that medical device instructions and labels should contain.@*CONCLUSIONS@#According to the current status of medical device specification supervision and drawing on international supervision experience, improvement suggestions are proposed in terms of refining the IFU requires to improve the quality of the instructions, e.g. dynamic adjustment of IFU management requirements, strengthen the management of IFU for home used medical devices, and improving the standardization and rationality of medical device IFU content. We should continue to maintain effective management of medical device IFU.

Qualitative and quantitative analysis of formaldehyde in samples of hair straighteners and suitability of the labels

Formaldehyde is an active compound, irregularly used in hair products, that has the property of straighten and waterproofing the wires. However, it is highly toxic and can stimulate dermatological hypersensitivity and cancer. In this context it is of fundamental importance the inspection of these products that can be used in safe conditions for the consumer, without formaldehyde in concentrations higher than the allowed. Thus, the aim of this research was the qualitative and quantitative identification formaldehyde in samples of hair straighteners that was obtained by donation in the beauty salons of Araraquara-SP. In addition, the analysis of the packaging labels of the products tested were conducted, following the requirements of the national legislation - RDC 07/2015 which defines the mandatory labeling standards for cosmetic products. A qualitative analysis for formaldehyde identification is based on the formation of a purple colored complex. The quantitative analysis was performed by spectrophotometry. The qualitative and quantitative formaldehyde analysis methods were applied to 13 bottles of hair straighteners. When submitted to qualitative analysis, all samples showed formaldehyde presence. The quantitative analysis demonstrated that the samples identified as B, C, D, E, G, H, I, J and M presented formaldehyde concentration of 3.5 to 14.5%, which is above of the limit recommended by the National Health Surveillance Agency (ANVISA), of 0.2%. In the label analysis, in all samples were found irregularities.(AU)

Regulatory framework for dietary supplements and the public health challenge / Marco regulatório dos suplementos alimentares e o desafio à saúde pública

ABSTRACT OBJECTIVE The new regulatory framework for dietary supplements in Brazil prompted this analysis of the current outlook of these products and the challenges posed by the new guidelines. METHODS We conducted a qualitative, observational and descriptive study of dietary supplements commercialized in Brazilian online stores with the help of the Google® search tool. We considered the ingredients on the labels, the effects attributed to these products and the commercial claims used as a means of promoting them to assess the necessary changes for the legal framework in the new guidelines. Finally, with the help of a database, we compared the effects declared by the manufacturers and attributed to certain ingredients with the scientific evidence described in literature. RESULTS In total, we purchased 44 dietary supplements from Brazilian online stores (n = 7). Of the samples studied, 34.2% could not be classified in the category Dietary Supplements, as recommended by the new regulation of the Brazilian Health Regulatory Agency due to the presence of prohibited substances; 16% of products should be commercialized as medicines. Regarding the commercial appeals, 97.7% had banned expressions. Numerous claims of effects attributed to certain products were characterized as consumer fraud because they have no scientific evidence. CONCLUSIONS The necessary changes represent a major regulatory and production challenge due to the wide range of dietary supplements and markets, an effort that aims to protect the consumers' health. Some previous gaps in the regulatory framework were not fully solved.

RESUMO OBJETIVO O novo marco regulatório para os suplementos alimentares no Brasil instigou a presente análise do panorama atual desses produtos e os desafios impostos pelas novas diretrizes. MÉTODOS Foi realizado um estudo qualitativo, observacional e descritivo dos suplementos alimentares comercializados em lojas virtuais brasileiras, com o auxílio da ferramenta de busca Google®. Os ingredientes declarados nos rótulos, bem como os efeitos atribuídos a esses produtos e as alegações comerciais utilizadas como forma de promovê-los foram levados em consideração a fim de avaliarmos as mudanças necessárias para o enquadramento legal nas novas diretrizes. Por fim, com o auxílio de base de dados, foram comparados os efeitos declarados pelos fabricantes e atribuídos a determinados ingredientes com as evidências científicas descritas na literatura. RESULTADOS No total, foram adquiridos 44 suplementos alimentares provenientes de lojas virtuais brasileiras (n = 7). Das amostras estudadas, 34,2% não poderiam ser enquadradas na categoria Suplementos Alimentares, conforme preconiza a nova regulação da Agência Nacional de Vigilância Sanitária, em decorrência de presença de substâncias não permitidas; 16% dos produtos deveriam ser comercializados como medicamentos. Quanto aos apelos comerciais, 97,7% apresentavam expressões não permitidas. Inúmeras alegações de efeitos atribuídos a determinados produtos, por não possuírem comprovação científica, foram caracterizadas como fraude contra o consumidor. CONCLUSÕES Dada a extensa gama de suplementos alimentares e pontos de comercialização, as mudanças necessárias representam um grande desafio regulatório e de produção, esforço este que visa a proteger a saúde dos consumidores. Algumas lacunas previamente existentes ao marco regulatório ainda não foram totalmente solucionadas.

Fluoride content in children's dentifrices marketed in Lima, Peru

Abstract The aim of the present study was to determine the concentration of total fluoride (TF) and total soluble fluoride (TSF) in children's dentifrices marketed in the city of Lima, Peru. Three samples of 23 dentifrices (4 without fluoride and 19 with fluoride) were purchased in different pharmacies in Lima, Peru. The TF and TSF concentrations found in the dentifrices were determined by ion-selective electrode, expressed in ppm F (μg F/g of dentifrice). The TF concentration in the majority of the fluoride toothpastes matched that shown on the label, except for one declared as 1450 ppm F by the manufacturer, whereas only 515.1 ppm F was found. The concentration of TSF found in the fluoride toothpastes ranged from 457.5 to 1134.8 ppm F. All the dentifrices were formulated with silica, but one also presented calcium carbonate. In conclusion, 83% of the children's dentifrices marketed in Lima, Peru, were fluoridated, but only 53% contained a TSF concentration greater than 1000 ppm F, the minimum concentration required to provide an anticaries effect.

Medicine package inserts from the users' perspective: are they read and understood? / Bulas de medicamentos sob a perspectiva dos usuários: elas são lidas e compreendidas?

ABSTRACT: Introduction: The written information on medicines has been acknowledged as an important tool for health education. Objective: To analyze the use and understanding of medicine package inserts by users and assess sociodemographic and medical factors associated with their comprehension. Method: Data in this analysis are part of the PNAUM National Survey - a cross-sectional population-based study conducted in Brazil. Descriptive statistics and the Pearson χ2 tests were performed to compare proportions between sociodemographic and medical characteristics, as well as use and understanding of medicine package inserts. Results: A total of 28.427 individuals responded to questions related to medicine package inserts. From these, 59.6% (95%CI 57.7 - 61.5) said they usually read the inserts, and 98.4% (95%CI 98.0 - 98.8) considered them necessary. Among people who read the medicine package inserts, more than half indicated difficulties with legibility (57.4%; 95%CI 55,2 - 59,6) and readability (54.1%; 95%CI 52.1 - 56.1). People from a lower education level reported greater difficulty in understanding them. Conclusion: The larger portion of the population usually read medicine package inserts. Nevertheless, people have difficulty in reading and understanding them.

RESUMO: Introdução: A informação escrita sobre medicamentos tem sido reconhecida como uma ferramenta importante para a educação em saúde. Objetivo: Analisar o uso e compreensão de bulas de medicamentos pelos usuários e avaliar fatores sociodemográficos e médicos associados ao seu uso e compreensão. Método: Osdados nesta análise fazem parte da PNAUM - um estudo transversal de base populacional realizado nas cinco regiões brasileiras. Estatísticas descritivas e teste de χ2 de Pearson foram utilizados para comparar proporções entre características sociodemográficas e médicas, uso e compreensão das bulas. Resultados: Um total de 28.427 indivíduos responderam a questões relativas a bulas. Desse total, 59,6% (IC95% 57,7 - 61,5) responderam que geralmente leem as bulas e 98,4% (IC95% 98,0 - 98,8) as consideraram necessárias. Entre as pessoas que leram as bulas, mais da metade indicou dificuldades de legibilidade (57,4%; IC95% 55,2 - 59,6) e de leiturabilidade (54,1%; IC95% 52,1 - 56,1) das bulas. As pessoas com menos educação relataram maior dificuldade em compreendê-las. Conclusões: A maioria da população tem o costume de ler as bulas, no entanto as pessoas consideram-nas difíceis de ler e compreender.

Safety and efficacy in actual clinical practice of once-weekly subcutaneous teriparatide for osteoporosis patients with a high fracture risk

OBJECTIVES: To reassess the safety and efficacy of once-weekly teriparatide 56.5 mg in osteoporosis patients with a high fracture risk. METHODS: This postmarketing observational study was conducted at 72 weeks according to the package insert. Of the 3573 Japanese osteoporosis patients in the safety analysis set, 91.80% were women, the mean age was 78.1 years, and 69.89% had a history of prevalent fragility fractures, indicating that a high proportion of patients at high risk of fracture were enrolled. RESULTS: Persistence with weekly teriparatide treatment was 59.36%, and 38.95% at 24 and 72 weeks, respectively. Adverse drug reactions (ADRs) were reported in 898 patients (25.13%), and serious ADRs were reported in 26 patients (0.73%). The most frequent ADRs were nausea, vomiting, and headache. The cumulative incidence of new vertebral fractures 72 weeks after the start of treatment was 3.31%. Increases in the bone mineral density were observed in the lumbar spine, femoral neck, and proximal femur. The serum levels of the bone formation markers, procollagen type I N-terminal propeptide and bone-type alkaline phosphatase, increased slightly at 24 weeks and then decreased to baseline levels. At 24 and 72 weeks, the bone resorption markers, serum cross-linked N-terminal telopeptide of type I collagen and urinary cross-linked N-terminal telopeptide of type I collagen, were the same as or slightly lower than at baseline. Visual analogue scale scores for low back pain also decreased. CONCLUSIONS: The present results showed that once-weekly teriparatide may also be useful for osteoporosis patients with a high risk of fracture.

Evaluation of Mineral Contents of Multi-Vitamin and Minerals Currently Sold in South Korea

Dietary supplements are popular worldwide and their use has been increasing. The purpose of this study was to evaluate the mineral contents of multi-vitamins and minerals (MVMs) in most commonly sold among dietary supplements. Ninety popular MVM supplements sold in South Korea were surveyed regarding their characteristics and ingredients including minerals listed on the labels through off-line and on-line search. Daily mineral contents of the MVM supplements were compared with Korean Dietary Reference Intakes (DRIs) by target populations. The average price of 90 MVM supplements was $41.3 per bottle, with a price of $0.9 per day and the average number of minerals contained per supplement was 4.7. A total 14 minerals were found in the MVM supplements including calcium, phosphorus, sodium, potassium, and magnesium. Nine minerals (e.g. calcium, magnesium, and iron) were included in more than 30% of the MVM supplements examined. When daily mineral dose of MVMs was compared to DRIs, calcium was the lowest (34.0% of recommended intake [RI]) and chromium was the highest (218.7% of adequate intake [AI]), and zinc, copper, selenium, and chromium were also higher than their RI or AI levels. The daily mineral contents of the 90 MVM supplements were below the tolerable upper-intake level, but some minerals were higher than RI or AI with high variance among products. Therefore, there is a great need to educate the public for the adequate selection and use of MVM supplements based on the contents of MVM supplements and individual's mineral intake derived from the diet.

Stability of antioxidant vitamins in commercial vitamin supplements

The stability of vitamins A, E, and C was determined in 12 brands of vitamin supplements over a 12-month storage period. The variations in concentrations of these vitamins across three different batches of five brands were measured. Vitamins A and E was determined by HPLC method, and vitamin C was measured by using potentiometric titration. All samples for stability studies were maintained at room temperature and protected from light. Measurements were carried out in the first semester of the expiration date and then every six months up to 12 months of storage. After this period, only one sample showed no significant decrease in vitamin A and E concentrations in relation to the concentrations measured at the beginning of the study. The concentration of vitamin C showed no significant decrease in 50% of the samples after 6 months of storage, although after 12 months, 92% had significant losses in concentration. The analysis of the different batches showed significant variations in the vitamin levels, which do not seem to be significant for inspection purposes considering the tolerance outlined in the legislation. Over-fortification of vitamin supplements during manufacture seems to be required, but the additional amount of supplementation will depend on each sample.

Fluoride concentrations in salt marketed in Managua, Nicaragua

Abstract Nicaraguan legislation has established that fluoride concentrations in salt should be 200-225 mg/kg, but no report describes fluoride concentrations in salt marketed in this country. We evaluated the fluoride concentrations in 33 packages of salt of 11 brands (n = 3 each) purchased in Managua, Nicaragua. According to the package information, 9 of the 11 brands were fluoridated. Six aliquots of each package were weighed (mean 2.5 ± 0.3 g; n = 198) and dissolved in 0.025 g/ml water. Duplicates of 1.0 ml of solutions prepared were buffered (1:1; v/v) with TISAB II. Fluoride concentrations were determined with ion-specific electrode, calibrated with standard solutions (0.25-16.0 μg F/ml) mixed (1:1; v/v) with TISAB II added to 0.025 g (p.a.) NaCl/ml. The mean (± standard deviation, n = 3) fluoride concentrations of two fluoridated brands were in accord with Nicaraguan law (209.8 ± 48.0 and 211.4 ± 26.0 mg F/kg), and those of five brands were below the mandated range (131.0 ± 34.3, 180.6 ± 12.3, 184.6 ± 34.8, 190 ± 47.2, and 199.0 ± 18.9 mg F/kg); two brands contained only traces of fluoride. The two non-fluoridated brands had traces of fluoride. The findings show that the surveillance system for the salt fluoridation program in Nicaragua should be improved, as most salt analyzed violated the requirements of the national legislation.

Eficacia de las etiquetas de advertencia en las cajetillas de cigarrillo / Effectiveness of cigarette-pack warning labels in capturing the attention of smokers and nonsmokers / Eficácia das tarjas de advertência em maços de cigarro para atrair a atenção de fumantes e não fumantes

RESUMEN Objetivo Establecer la capacidad que tienen las etiquetas de advertencia con el tamaño mínimo exigido por la Organización Mundial de la Salud para capturar la atención en fumadores y no fumadores. Métodos En el estudio se incluyeron 30 fumadores y 30 no fumadores, quienes realizaron una prueba de detección del punto (dot-probe) en la cual observaron, de manera simultánea, imágenes de cajetillas de cigarrillo divididas en dos: la parte superior contenía la marca de los cigarrillos y la parte inferior contenía la etiqueta de advertencia. Durante la tarea, se registró la actividad cerebral a través de los potenciales relacionados a eventos del tipo potencial negativo que ocurre aproximadamente a los 200 ms en la zona posterior contralateral al estímulo (N2pc) y negatividad contralateral posterior sostenida (SPCN, por sus siglas en inglés), los cuales son indicadores de atención temprana y sostenida. Resultados En ambos grupos se encontró mayor amplitud de los potenciales N2pc y SPCN hacia la porción de la cajetilla que contiene la marca de cigarrillos. Sin embargo, el tiempo de reacción fue menor ante la etiqueta de advertencia en la tarea dot-probe. Conclusiones Los resultados sugieren que, al inicio, la atención se dirige hacia la marca de los cigarrillos y luego hacia la etiqueta de advertencia. La incapacidad de las etiquetas de advertencia para capturar la atención en las primeras fases disminuye su eficacia, sobre todo en fumadores. Se sugiere aumentar el tamaño de las etiquetas de advertencia para favorecer un incremento en la respuesta de atención.

ABSTRACT Objective To determine the ability of cigarette-pack warning labels, of the minimum size required by the World Health Organization, to capture the attention of smokers and nonsmokers. Methods In this study, 30 smokers and 30 nonsmokers completed a dot-probe task in which they simultaneously observed images of cigarette packs split in two: the top contained the cigarette brand and the bottom contained the warning label. During the task, brain activity was recorded through two event-related potentials of the negative-polarity type--the potential that occurs in the posterior-contralateral zone approximately 200 ms after a stimulus (N2pc) and the sustained posterior contralateral negativity (SPCN) response--which are indicators of early and sustained attention. Results In both groups, a greater amplitude of N2pc and SPCN potentials was found for the part of the pack containing the cigarette brand. However, during the dot-probe task, reaction times were shorter for the warning label. Conclusions These results suggest that, initially, attention is focused on the cigarette brand, and only then on the warning label. The inability of warning labels to capture early-phase attention decreases their effectiveness, especially in smokers. We suggest that warning labels be enlarged to facilitate increased attention response.

RESUMO Objetivo Determinar a capacidade das tarjas de advertência com o tamanho mínimo exigido pela Organização Mundial da Saúde (OMS) de atrair a atenção de fumantes e não fumantes. Métodos A amostra do estudo consistiu de 30 fumantes e 30 não fumantes que foram testados com uma tarefa de sondagem (dot-probe task) em que tiveram de observar simultaneamente imagens de um maço de cigarro dividido ao meio: a parte superior continha a marca do cigarro e a parte inferior continha a tarja de advertência. Durante o teste, foi registrada a atividade cerebral com a análise de potenciais evocados relacionados a eventos do tipo potencial negativo que ocorre em cerca de 200 ms na área posterior contralateral ao estímulo (N2pc) e da ocorrência de negatividade contralateral posterior sustentada (SPCN, em inglês), que são indicadores de atenção mais rápida e sustentada. Resultados Em ambos os grupos de participantes foi observada maior amplitude dos potenciais N2pc e SPCN na parte do maço que continha a marca. Porém, o tempo de reação na tarefa de sondagem foi menor diante da tarja de advertência. Conclusões Os resultados deste estudo sugerem que, ao início, a atenção é dirigida à marca do cigarro e depois à tarja de advertência. A incapacidade da tarja de advertência de atrair a atenção nas primeiras fases diminui sua eficácia, sobretudo entre os fumantes. Recomenda-se aumentar o tamanho das tarjas de advertência para estimular um incremento na resposta de atenção.

Concurrent Use of Nefopam vs. Ketorolac with Opioid Analgesic for Post-operative Pain Management

OBJECTIVE: To compare the analgesic effects and adverse drug reactions (ADRs) of fentanyl intravenous patient-controlled analgesia (ivPCA) with nefopam, a centrally acting analgesic agent with demonstrated opioid sparing activity, as compared to ketorolac in a tertiary teaching hospital. METHODS: A retrospective evaluation of electronic medical records was conducted on patient records including either nefopam or ketorolac with opioid ivPCA for post-operative pain management in general surgery department from January to December 2014. The status of pain control and ADRs were collected. RESULTS: Out of 6,330 general surgery cases, nefopam was given in 153 prescriptions (6.9%) and ketorolac in 81 prescriptions (3.6%). The level of pain control was not different between two groups (70.9% vs. 75.3%; p = 0.51), but ADRs were more frequently reported in nefopam group (9.8% vs. 2.5%; p < 0.05). New ADRs of hot flushes (n = 1) and paresthesia in hands (n = 1) were reported in nefopam group and they were unlisted in the approved package insert. No serious ADRs were reported in both groups. CONCLUSION: Our findings presented that nefopam showed a similar analgesic effect and higher ADR rates compared to ketorolac as an adjuvant to fentanyl iv PCA for postoperative pain management in general surgery patients in South Korea.

Análise da rotulagem nutricional de pães de forma com informação nutricional complementar comercializados no município de Belo Horizonte - MG / Analysis of nutritional label of breads with complementary nutritional information sold in Belo Horizonte ­ MG

A busca da população por alimentos práticos, rápidos e saudáveis tem aumentado a preocupação com a rotulagem nutricional visto que este é o principal veículo de informação ao consumidor sobre as características nutricionais dos alimentos embalados. Este estudo objetivou verificar o índice de conformidades e inconformidades da rotulagem de pães embalados diante das regulamentações vigentes. Para tanto, foi avaliada a rotulagem de 23 pães de forma com informação nutricional complementar disponíveis na região metropolitana de Belo Horizonte-MG. As análises foram realizadas através de uma lista de verificação produzida a partir dos requisitos estabelecidos pela legislação sendo classificados como "adequado" ou "inadequado". Os resultados demonstraram que 95% dos rótulos analisados foram classificados como inadequado em algum dos parâmetros avaliados, sendo que 26% dos rótulos foram inadequados no parâmetro "Denominação de venda" e 35% no parâmetro "Tabela de Informação nutricional". O quesito "Informação Nutricional Complementar" obteve o maior número de inadequações concentrando 82,6% da totalidade avaliada. Com base nos resultados obtidos concluiu-se que a falta de entendimento por parte dos fabricantes das leis detentoras da rotulagem nutricional no país entre outros fatores associados, podem explicar as frequentes falhas na rotulagem de alimentos embalados, o que pode ocasionar privação à informação e direito de escolha dos consumidores brasileiros.

The search of the population for fast, healthy and practical foods has increased concern with nutritional labeling, since this is the main vehicle for informing the consum labeling of packaged breads considering the current regulations. The present work evaluated the labeling of 23 breads with complementary nutritional information. The analyzes were carried out through a checklist in which the requirements established by current legislation were used and classified as "satisfactory" or "unsatisfactory". The results showed that 95% of the analyzed labels were classified as unsatisfactory in any of the evaluated parameters, 26% of the labels evaluated were unsatisfactory in the parameter "Sales denomination", 35% in the parameter "Nutrition Information Table" and the " Nutritional Complementary "obtained the greatest number of inadequacies, concentrating 82.6% of the totality evaluated. Based on the results obtained, it is concluded that the lack of understanding by the manufacturers of the laws that have the nutritional labeling in the country, among other associated factors can explain the frequent failures in the labeling of packaged foods, which can cause deprivation to the information and wrong choice of Brazilian consumers.

An Overview of the Package Insert and Contraindications of Filler Products in Korea / 대한피부과학회지

Filler injection is an extremely popular cosmetic procedure in Korea, but surprisingly few dermatologists are aware of the package inserts in filler products. In the era of legal dispute, it is important that we fully understand the indications, contraindications, and side effects of the individual filler products. The purpose of this paper is to provide a general overview of the contents of package inserts of filler products that are commercially available in Korea, especially in terms of the contraindications of filler injection. The authors emphasize that greater improvement in the Korean package inserts of filler products can be expected. Currently, practicing physicians are usually blamed for filler complications. We also found many significant translational errors. We hope that dermatologists take more interest in filler package inserts by reading this overview.

The Understanding of, and Attitude towards Bakery Food Labeling and Their Effects on Consumer Purchase Intention - The Moderating Role of Health Consciousness -

This study examined the awareness, understanding, attitudes, and purchase intention regarding food labeling on bakery products in the context of health consciousness. The purpose of the study was to provide basic data for bakery product labeling, which has been insufficient to date, and to develop measures to expand the labeling system. The results of the study showed that higher subjective understanding and better attitude towards bakery food labeling can positively increase the purchase intention. We believe that the bakery industry needs to promote food labeling proactively, while also developing products addressing health concerns. This study is also valuable to academia because it provides insights into the relationship between the consumer's understanding of and attitudes towards nutritional information and purchase intention. In addition, it is beneficial to the bakery industry because it establishes marketing strategies that increase the purchase intent among both consumers with high health consciousness and those who infrequently purchase baked goods.

Análise do uso de fitas de marcação de instrumentais cirúrgicos: revisão integrativa / Analysis of the use of surgical instruments marking tapes: integrative review / Análisis del uso de cintas adhesivas de marcación de los instrumentos quirúrgicos: revisión integradora

Objetivo: Identificar artigos relacionados ao uso de fitas de marcação de instrumental cirúrgico e descrever boas práticas para o seu uso. Método: Revisão integrativa da literatura de artigos hospedados na Biblioteca Virtual em Saúde (BVS), com pesquisas no site e grupo de discussão online da Association of periOperitative Registered Nurses (AORN) e utilização da busca inversa de publicações. Foram aceitos estudos escritos nos idiomas português, inglês e espanhol, sem recorte temporal, que apresentassem informações relacionadas ao uso da fita de marcação de instrumental e que dispunham seus textos completos via online. Resultados: Foram encontrados 13 artigos que abordaram o perigo e os benefícios quanto ao seu uso. Conclusão: A revisão integrativa permitiu evidenciar que os estudos são escassos e os poucos trabalhos existentes possuem níveis de evidências científicas baixos, não oferecendo graus de recomendações fortes o suficiente para auxiliar a tomada de decisão prática.

Objective: Identify articles related to the use of surgical instruments marking tapes and describe best practices for their use. Method: Integrative literature review of articles hosted on the Virtual Health Library (BVS), with research on the website and group of online discussions of the Association of periOperitative Registered Nurses (AORN) and use of reverse search of publications. Written studies in Portuguese, English, and Spanish, with no specific time frame, which present information related to the use of instrumental marking tape and had their full texts online accepted. Results: Thirteen articles that addressed risks and benefits concerning the use of marking tapes were found. Conclusion: The integrative review highlighted studies are scarce and the few existing articles show low levels of scientific evidence, not offering strong enough degrees of recommendations to support the decision making process.

Objetivo: Identificar los artículos relacionados con el uso de las cintas adhesivas de marcación de los instrumentos quirúrgicos y describir las buenas prácticas para su uso. Métodos: Revisión integradora de la literatura de los artículos alojados en la Biblioteca Virtual en Salud (BVS), con búsqueda en el sitio y en los grupos de discusión de la Asociación de Enfermeras Registradas de Peri-operación (AORN), y el uso de búsqueda inversa de las publicaciones. Fueron aceptos estudios en los idiomas portugués, inglés y español, sin un exacto período de tiempo, los cuales presentaban información relacionada con el uso de la cinta adhesiva de marcación instrumental y que tenían sus textos completos a través de la Internet. Resultados: Se encontraron 13 artículos que abordan los riesgos y los beneficios del su uso. Conclusión: La revisión integradora ha puesto de relieve que los estudios son escasos y los pocos trabajos existentes tienen bajos niveles de evidencia científica, y por eso no ofrecen grados de recomendaciones suficientemente fuertes para ayudar a la toma de decisiones práctica.

Qualidade de suplementos proteicos: avaliação da composição e rotulagem / Quality of protein supplements: evaluation of composition and labeling

O consumo de suplementos alimentares por praticantes de atividade física tem se tornado umhábito comum, destacando-se aqueles de fonte proteica. Contudo, o uso indiscriminado destessuplementos no Brasil constitui tema de preocupação, pois dietas com elevados níveis proteicospodem ser prejudiciais à saúde. Soma-se a este quadro o fato de que levantamentos recentes sobrea qualidade desses produtos indicaram um número significativo de não conformidades em relaçãoaos requisitos regulamentados. Neste contexto, o objetivo deste trabalho foi avaliar a conformidadede suplementos proteicos para atletas, do tipo whey protein, quanto à composição centesimale requisitos para rotulagem. Os parâmetros da composição nutricional para os quais foramidentificadas não conformidades foram teores de lipídeos totais (70 %) e carboidratos (30 %).Não conformidades de rotulagem foram evidenciadas em 100 % das amostras, sendo mais frequentesaquelas relacionadas à informação da medida caseira, prazo de validade, indicação terapêuticae denominação de venda. A falta de padronização nas orientações de uso foi também consideradacrítica, pelo potencial de induzir um consumo excessivo de proteínas. Os resultados desseestudo apontaram para a urgente necessidade de se assegurar a qualidade dos suplementos proteicosconsumidos no país.

The consumption of dietary supplements for physical activity practitioners has becomecommon, highlighting the protein source supplements. However, the indiscriminate use of thesesupplements is a topic of concern in Brazil, because diet with high protein levels can be harmfulto health. An aggravating is the fact that recent surveys on the quality of protein supplementsshowed a significant number of non-compliance products considering the regulated requirements.In this context, the objective of this study was to evaluate the compliance of protein supplementsfor athletes, whey protein type, in relation to the chemical composition and regulated requirementsfor labelling. The parameters related to composition that were in disagreement with the Brazilianregulations were total lipids (70 %) and carbohydrates (30 %). Nonconformities were found inlabelling of 100 % of samples, being more frequent those related to household measure information,validity, therapeutic indication and sale name. An important aspect of the labelling was the lackof standardization in the recommendations for use by the manufactures because some of whichcould lead the users to excessive protein intake. The results of this study indicated the urgent need ofquality assurance of protein supplements consumed in Brazil.