Las reservas de material sanitario estratégico. Reflexiones legales y económicas / [Reserves of strategic medical supplies. Legal and economic reflections]

En este trabajo se presenta un análisis de los principales problemas que plantean las reservas de material sanitario estratégico. Entre otras cuestiones se aborda las referidas a la identificación de la agencia responsable de crear tales reservas, qué se ha de reservar, cómo se han de gestionar las reservas, la trascendencia del enfoque conjunto, así como la necesidad de establecer estrategias adecuadas para emergencias y catástrofes que puedan tener impacto en la salud pública. (AU)

This paper presents an analysis of the key issues posed by strategic healthcare material reserves. Among other matters, it addresses those related to identifying the agency responsible for creating such reserves, what should be reserved, how reserves should be managed, the significance of a collaborative approach, as well as the necessity to establish appropriate strategies for emergencies and disasters that may impact public health. (AU)

Políticas desenvolvimentistas e mulheres quebradeiras de coco babaçu: capturas contemporâneas / Developmentalist policies and babassu coconut-breaking women: contemporary catches / Políticas desarrollistas y las mujeres que rompen coco babaçu: capturas contemporáneas

Este estudo propõe analisar as relações e os processos de subjetivação de mulheres quebradeiras de coco babaçu decorrentes das intervenções de políticas desenvolvimentistas em seus territórios de vida e reverberações no Movimento Interestadual de Quebradeiras de Coco Babaçu (MIQCB). Sob a perspectiva ético-estético-política da Cartografia, acompanhamos as narrativas das histórias de vida de 24 mulheres, suas atividades cotidianas e eventos do MIQCB, também analisamos os documentos das políticas. Entendemos que, ao passo que tais políticas de desenvolvimento rural contribuem para a melhoria das condições de vida, em termos materiais e simbólicos, elas também produzem ressonâncias relacionadas ao modo de subjetivação do tipo "empresário de si", que agenciam seus modos de viver, de produzir e de se relacionar consigo e com os outros na lógica capitalista neoliberal. A resistência às capturas neoliberais também estão presentes ao ampliarem as mobilizações coletivas do próprio movimento, articulando com outros na produção de um "comum".(AU)

This study proposes to analyze the relations and the processes of subjectivation of babassu coconut-breaker women arising from developmental policy interventions in their territories of life and reverberations in the Babassu Coconut-breaker Interstate Movement (MIQCB). From the ethical-aesthetic-political perspective of Cartography, we followed the narratives of the life stories of 24 women, their daily activities and promoted events by MIQCB, we also analyzed the policy documents. We understand that while these policies of rural development contribute to improve the living conditions, in material and symbolic terms, they also produce resonances related to the "self-entrepreneur" mode of subjectivation, which has been handling their ways of living, producing, and relating to themselves and others in the neoliberal capitalist logic. Resistance to neoliberal captures is also present as they expand the collective mobilizations of the movement itself, articulating with others, in the production of a "common."(AU)

Este estudio tiene como objetivo analizar los procesos de subjetivación de las mujeres que rompen coco babaçu que surgen de las intervenciones de las políticas de desarrollo en sus territorios de vida y las reverberaciones en el Movimiento Interestadual de las Mujeres que Rompen Coco Babaçu (MIQCB). Desde la perspectiva ético-estético-política de la Cartografía, seguimos las narraciones de las historias de vida de 24 mujeres, sus actividades diarias y eventos del MIQCB, y también analizamos los documentos de las políticas. Si bien estas políticas han contribuido a mejorar las condiciones de vida de las mujeres, en términos materiales y simbólicos, también han producido resonancias del modo de subjetivación "autoempresarial", que ha agenciado sus formas de vivir, producir y relacionarse consigo mismas y con los demás en la lógica capitalista neoliberal. La resistencia a las capturas neoliberales también está presente cuando amplían las movilizaciones colectivas del propio movimiento, articulándose con otros en la producción de un "común".(AU)

Las cinco claves de inocuidad de los alimentos

En este apartado se analizan los alimentos seguros, el agua, el vencimiento, los envases y el etiquetado

Eventos adversos supuestamente atribuidos a la vacunación o inmunización (ESAVI) reportados a la vacuna contra la COVID-19: Informe de Farmacovigilancia / Adverse Events Supposedly Attributed to Vaccination or Immunization (ESAVI) Reported to the COVID-19 Vaccine: Pharmacovigilance Report

El informe consta de 3 secciones: la primera contiene los antecedentes, la segunda los resultados y análisis y el tercero y último las conclusiones y recomendaciones sobre eventos adversos supuestamente atribuido a la inmunización o vacunación (ESAVI) reportados a la vacuna contra la COVID-19. Periodo del 09 de febrero al 31 de octubre de 2021.

Hygienic-sanitary quality and antimicrobial sensitivity profile of Escherichia coli in milk and cheese sold illegally in municipalities of northern Mato Grosso, Brazil

Products such as milk and cheese produced by hand and sold by small producers in open markets and at home are a reality in Brazil, despite legal prohibitions. In many cases, this leads to the production of food without hygienic conditions, which may constitute an important source of transmission of foodborne diseases and a danger to public health. This study proposes to examine the hygienic-sanitary quality of milk and cheese sold illegally in municipalities of northern Mato Grosso, Brazil, to undertake a phenotypical investigation of the presence of resistance of isolated colonies to antimicrobials and to detect the production of ß-lactamase enzymes: extended-spectrum ß-lactamase (ESBL), AmpC ß-lactamases (AmpC) and carbapenemases. The 25 milk and 37 cheese samples analyzed were subjected to the most probable number (MPN) test, isolation on eosin-methylene blue agar (EMB) agar and Escherichia coli identification by biochemical tests and disk diffusion test. Results showed that 76% of the milk samples and 67.57% of the cheese samples had thermotolerant coliform counts above the value allowed by the legislation. The milk and cheese isolates showed 15.79 and 5.88% resistance, respectively, to at least one of the tested antimicrobials. No ß-lactamase enzyme production was observed in the isolates.

Concentrações de nitrato em águas de abastecimento público de 88 municípios da Rede Regional de Atenção à Saúde 13 do estado de São Paulo, Brasil / Concentrations of nitrate in the public water supply of 88 municipalities of the Regional Health Care Network 13 of the São Paulo State, Brazil

Este trabalho apresenta as concentrações de nitrato e suas correlações com as demais variáveis obtidas da análise de 21 parâmetros físico-químicos em 4.347 amostras de águas de abastecimento público de 88 municípios da região nordeste do Estado de São Paulo, Brasil. Os parâmetros analisados foram temperatura, pH, cloro residual livre, cor aparente, turbidez, condutividade e concentrações de lítio, sódio, amônio, potássio, cálcio, magnésio, fluoreto, clorito, bromato, cloreto, brometo, clorato, nitrato, fosfato e sulfato. Análises de componentes principais, incluindo-se as variáveis condutividade e concentrações de nitrato, cloreto, cálcio e magnésio na água, indicaram um grupo de 15 municípios com concentrações relevantes de nitrato. Foi realizada a análise univariada, e foi sugerido o estabelecimento de estratégias no gerenciamento inicial de contaminações de águas subterrâneas. No planejamento de ações entre os diversos atores envolvidos com a gestão da água subterrânea destinada ao consumo humano da região e no monitoramento de sua qualidade, devem ser considerados os níveis de nitrato, assim como os perfis físico-químicos das águas e a complexidade dos sistemas de abastecimento. Estas ações incluem procedimentos para investigar e mitigar contaminações, para garantir a potabilidade da água consumida pela população. (AU)

This paper presents the nitrate concentrations and their correlations with other variables obtained by analyzing 21 physical-chemical parameters in 4,347 samples from public water supply of 88 municipalities in the northeast region of the State of São Paulo, Brazil. The analyzed parameters were temperature, pH, free residual chlorine, apparent color, turbidity, conductivity, and concentrations of lithium, sodium, ammonium, potassium, calcium, magnesium, fluoride, chlorite, bromate, chloride, bromide, chlorate, nitrate, phosphate, and sulfate. The principal component analysis, involving the conductivity and the concentrations of nitrate, chloride, calcium, and magnesium, showed a group of 15 municipalities with relevant concentrations of nitrate. As for the univariate analysis it is suggested to apply strategies in the initial management of groundwater contaminations. It has been suggested to plan the actions among the various actors involved in the management of groundwater, which is intended for human consumption in the region, and for its quality monitoring. It has to consider not only the nitrate levels but also the water physical-chemical profiles and the complexity of the supply systems. These actions include the contaminants investigation and mitigation for ensuring the potability of the water consumed by the population. (AU)

Logística reversa de medicamentos: um relato de experiência do estado do Paraná / Pharmaceutical reverse logistics: an experience report from the state of Paraná

O presente trabalho descreve o relato de experiência da Divisão de Vigilância Sanitária de Produtos da Secretaria de Estado da Saúde do Paraná na Campanha de Logística Reversa de Medicamentos Domiciliares Vencidos ou em Desuso realizada no ano de 2018 pelo Governo do Estado, em parceria com o Sindicato da Indústria de Produtos Farmacêuticos no Estado de São Paulo e outras entidades. A ação teve duração de 60 dias com a participação de 250 pontos de coleta distribuídos em farmácias públicas e privadas de todas as Regionais de Saúde do Estado. Os resíduos de medicamentos coletados ultrapassaram duas toneladas. Foi possível identificar os recursos necessários para implantação dessa política com participação de atores da cadeia farmacêutica. A atuação do Governo do Estado foi essencial para aproximação dos setores e articulação na Campanha. Contudo, salienta-se a necessidade de interlocução dos entes responsáveis pelo processo para execução permanente desta política no Estado. (AU)

This paper describes the experience report of the Health Surveillance Division of the State Health Department of Paraná in the Pharmaceutical Reverse Logistics Campaign for Expired or Unused Home Medicines held in 2018 by the State Government, in partnership with the Pharmaceuticals Industry Union of the State of São Paulo and other entities. The action lasted 60 days with the participation of 250 collection points distributed in public and private pharmacies of all State Health Units. The drug residues collected exceeded two tons. It was possible to identify the resources required to implement this policy with the participation of actors from the pharmaceutical chain. The participation of the State Government was essential to bring the sectors together, and to articulate the Campaign. However, the need of dialogue amongentities in charge of the process, for the permanent implementation of this policy in the State, shall be highlighted. (AU)

Biologically active dietary supplement for correction of exchange disorders in nervous system diseases

The prescription composition of the biologically active dietary supplement (BADS) Oleopren Neuro has been scientifically substantiated through the pharmacological evaluation of the effective agents, polyprenols being the main of them. The technology of an innovative product has been developed, with the establishment of adjustable production parameters securing high organoleptic advantages and stability of the BADS. Regulated indicators of quality and nutritional value have been determined. Sanitary toxicological and hygienic safety indicators of the product under development had been studied, which allowed to establish a shelf life of two years taking the safety margin of three months into account. The possible mechanisms of the dolichols effect on the metabolic status of the organism were considered. Clinical trials of the efficiency and functional focus of a specialized product on a representative group of patients with the dyscirculatory encephalopathy (DE) of vascular genesis stages I ­ II were conducted. The BADS were included in the diet of patients, along with the basic therapy, one capsule twice a day for 10 days. The materials obtained in this article allow to recommend the developed product as an efficient means of increasing the body's resistance to adverse effects of the environment, stressful situations, as well as psychoemotional and physical stress.

Abastecimento de imunobiológicos: soros e vacinas

Análise da eficácia do brometo de lauril dimetil benzil amônio 10% como sanitizante de equipamentos e superfícies em cozinha industrial / Analysis of the efficacy of lauryl dimethyl benzyl ammonium bromide 10% as a sanitizer of equipment and surfaces in industrial kitchen

A mudança nos padrões da população em relação ao cotidiano leva a questão sanitária a um patamar elevado. Grande parte das pessoas realiza suas refeições fora de casa, aumentando os surtos de doenças transmitidas por alimentos (DTA). Buscou-se, então, avaliar o uso do sanitizante Brometo de Lauril Dimetil Benzil Amônio 10% em diferentes superfícies (liquidificador industrial de inox, leiteira elétrica de inox e bancada para processamento de carne de inox) e sua influência na contagem padrão de mesófilos aeróbios estritos e facultativos viáveis (CPM) e no número mais provável de coliformes termotolerantes (NMP), ao longo do tempo. Para isto foram divididos em três grupos por superfície: hora 1 ­ 10 minutos após a aplicação do sanitizante, hora 4 e hora 8 ­ quatro e oito horas após a sanitização, respectivamente. A diferença entre as médias foi determinada por meio do programa estatístico SAS, pela utilização do proc glm e o teste de tukey. As amostras do liquidificador e da leiteira elétrica se portaram da mesma forma, não apresentando diferença ao longo do tempo com relação a CPM e NMP de coliformes termotolerantes (Liquidificador: 2,27± 1,93; 1,3± 0,61 e 1,27± 0,64 e Leiteira: 3,93± 5,25; 1,27± 0,64 e 1,97± 1,05; e Liquidificador: 1,2±1,56 ao longo do tempo e Leiteira: 1,34±1,45; 1,2±1,56 e 1,2±1,56; respectivamente). Enquanto que a bancada de processamento de carne de inox apresentou diferença entre as médias ao longo do período estabelecido para a CPM e NMP de coliformes (1,3± 0,61; 5,97± 6,28 e 37,63± 62,67; e 1,2±1,56; 1,22±1,54 e 1,2±1,56; respectivamente). Com isso, pode-se concluir que a bancada de inox apesar de apresentar aumento na quantidade de UFC/mL de CPM ainda mantém sua proteção a níveis seguros.

The change standard of population in relation to the everyday health issues leads to a high level. As most people place their meals in the street and disease outbreaks, food poisoning the villain. The objective was evaluate the use of sanitizer bromide lauryl dimethyl benzyl ammonium 10% on different surfaces (stainless steel industrial blender, milk electrical steel and stall for meat processing and stainless steel) and its influence on the count of mesophilic aerobic strict standard and optional viable (CMS) and most probable number of fecal coliform (NPM), over time, them were divided: hours 1 ­ to 10 minutes after application of sanitizer, 4 and 8 hours ­ four and eight hours after sanitization, respectively. The difference between means was determined using the statistical program SAS by using PROC GLM and Tukey test. Samples of the electrical milk industrial blender and behaved the same way, with no significant difference over time (Blender: 2.27± 1.93, 1.3± 0.61 and 1.27± 0.64 and Electrical milk: 3.93± 5.25, 1.27± 0.64 and 1.97± 1.05, and Blender: 1.2±1.56 over time and Electrical milk: 1.34±1.45, 1.2±1.56 and 1.2±1.56, respectively). While the bench meat processing stainless steel showed a difference between the averages over period specified, for CMS and NPM (1.3± 0.61, 5.97± 6.28 and 37.63± 62.67, and 1.2±1.56, 1.22±1.54 and 1.2±1.56, respectively). Thus, the stainless steel bench despite showing an increase in the number of CFU/ mL of CMS steel holds its protection to safe levels.

Condições higienicossanitárias do comércio ambulante de alimentos / Hygienic and Sanitary conditions of the street food trade

O comércio ambulante de alimentos é uma opção de trabalho e de fonte de renda, mas, devido as condições de manipulação e comercialização, os alimentos podem apresentar qualidade insatisfatória. No presente estudo transversal foram avaliadas as condições higienicossanitárias de comércios ambulantes de alimentos nos municípios de Vila Velha e Vitória, Espírito Santo, Brasil. A avaliação foi feita pela observação direta e aplicação de lista de verificação estruturada com 38 itens. Os comércios foram classificados conforme os critérios estabelecidos pela RDC nº 275/2002: Grupo 1 (76 a 100% de atendimento dos itens), Grupo 2 (51 a 75% de atendimento) e Grupo 3 (0 a 50% de atendimento). Quarenta e oito (80%) dos pontos de venda classificaram-se no Grupo 3 e 20% (n=12) no Grupo 2, e este resultado indica alto percentual de inadequação quanto as boas práticas de manipulação nos comércios ambulantes visitados. Foram detectadas falhas como inexistência de lixeiras, armazenamento sem controle de temperatura, inadequada higienização de superfícies, manipuladores sem apropriada higienização de mãos e ausência de licença sanitária. Neste contexto, sugere-se que sejam realizadas a adequação das condições de infraestrutura dos locais de comercialização, a adoção de programas de treinamento e a elaboração de regulamentos governamentais para este tipo de comércio.

Street food is an option and a source of income, but, due to the conditions of handling, the food quality could be unsatisfactory. Thus, a cross-sectional study was carried out to evaluate the hygienic and sanitary conditions of street foods trade in Vila Velha and Vitória - Espírito Santo State, Brazil. The evaluation was done by means of the direct observation and applying a checklist with 38 items. The street vended foods were classified according to the criteria established by DRC No . 275/2002: Group 1 (76 to 100% of the items attendance), Group 2 (51 to 75% of attendance) and Group 3 (0 to 50% of attendance). Eighty percent (n = 48) of the points of sale were classified into Group 3 and 20% (n = 12) into Group 2, and this result indicates a high percentage of inadequacy regarding good handling practices in the visited trades. Failures as the absence of dumps, the storage without temperature control, the inadequate surface cleaning, the incorrect hand hygiene and the absence of sanitary license were observed. Thus, it is suggested to adapt the infrastructure conditions, to adopt the training programs and to elaborate government regulations for this type of trade.

Proposals for harmonization of allergens regulation in the European Union

Allergen medicinal products in the European Union are regulated differently across the different Member States. Thus, whereas in some countries strict quality, safety and efficacy requirements are in place, in others, most allergens are on the market as Named Patient Products, without any regulatory oversight. This situation results on European allergic patients being exposed to totally different standards depending on where they live. Initiatives to correct this situation are needed (AU)

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La seguridad de las lámparas emisoras de radiación ultravioleta de uso cosmético desde el punto de vista de su regulación legal / Safety of UV lamps for cosmetic use: regulatory considerations

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Reacciones adversas a los antimicrobianos en Cuba (2003-2012) / Adverse antimicrobial reactions in Cuba (2003-2012)

Introducción: la disponibilidad y el consumo irracional de los antimicrobianos propician su uso inadecuado, lo que da lugar en ocasiones, a reacciones adversas. En la actualidad, estas constituyen un problema clínico- epidemiológico. Es preciso profundizar en el conocimiento de sus características en Cuba y el comportamiento en el tiempo para la toma de decisiones. Objetivos: describir las reacciones adversas a los antimicrobianos reportadas en Cuba y analizar el comportamiento de la tendencia, estacionalidad y pronóstico para el 2013 y 2014. Métodos: estudio descriptivo y longitudinal de serie de casos con un horizonte temporal de 10 años (2003–2012). La información se obtuvo de la base de datos nacional de farmacovigilancia. Resultados: se registraron 40 391 reportes de reacciones adversas a los antimicrobianos. Las reacciones a los antibacterianos representaron el 86,5 por ciento del total. Predominaron en las mujeres (64,3 por ciento) y en los menores de un año. Las afectaciones de la piel representaron el 47,9 por ciento, y las digestivas el 26,8 por ciento. La penicilina G fue el medicamento más notificado. Prevalecieron las reacciones adversas moderadas (58,2 por ciento). La tendencia fue creciente, y se observó estacionalidad. El pronóstico mostró un ascenso. Conclusiones: el incremento del reporte de reacciones adversas a los antimicrobianos, y el ascenso pronosticado, representan una alerta para el Sistema de Salud(AU)

Introduction: availability and irrational consumption of antimicrobials prompt their inadequate use and sometimes give rise to adverse reactions. At present, these reactions represent a clinical and epidemiological problem. It is necessary to deepen into the knowledge about their characteristics in Cuba and the behavior in the course of time for the decision making process.Objectives: to characterize the adverse antimicrobial reactions reported in Cuba and to analyze the behavior of tendencies, seasonality and prognosis for 2013 and 2014. Methods: longitudinal and descriptive study of case series in a ten-year period (2003-2012). Data were taken from national pharmacovigilance databases.Results: there were registered 40 391 reports of adverse antimicrobial reactions accounting for 86.5 percent of the total number of adverse reactions. They prevailed in females (64.3 percent) and in under one-year old infants. The skin illnesses represented 47.9 percent and digestive ones 26.8 percent. Penicillin G was the most reported drug. Moderate adverse reactions prevailed (58.2 percent). Tendency was growing, seasonality was observed and prognosis was on the rise.Conclusions: the increase in the number of reports of adverse antimicrobial reactions and the anticipated rise of them is an alert to the health care system(AU)

Reacciones adversas a los antimicrobianos en Cuba (2003-2012) / Adverse antimicrobial reactions in Cuba (2003-2012)

Introducción: la disponibilidad y el consumo irracional de los antimicrobianos propician su uso inadecuado, lo que da lugar en ocasiones, a reacciones adversas. En la actualidad, estas constituyen un problema clínico- epidemiológico. Es preciso profundizar en el conocimiento de sus características en Cuba y el comportamiento en el tiempo para la toma de decisiones. Objetivos: describir las reacciones adversas a los antimicrobianos reportadas en Cuba y analizar el comportamiento de la tendencia, estacionalidad y pronóstico para el 2013 y 2014. Métodos: estudio descriptivo y longitudinal de serie de casos con un horizonte temporal de 10 años (2003­2012). La información se obtuvo de la base de datos nacional de farmacovigilancia. Resultados: se registraron 40 391 reportes de reacciones adversas a los antimicrobianos. Las reacciones a los antibacterianos representaron el 86,5 por ciento del total. Predominaron en las mujeres (64,3 por ciento) y en los menores de un año. Las afectaciones de la piel representaron el 47,9 por ciento, y las digestivas el 26,8 por cienti. La penicilina G fue el medicamento más notificado. Prevalecieron las reacciones adversas moderadas (58,2 por ciento). La tendencia fue creciente, y se observó estacionalidad. El pronóstico mostró un ascenso. Conclusiones: el incremento del reporte de reacciones adversas a los antimicrobianos, y el ascenso pronosticado, representan una alerta para el Sistema de Salud(AU)

Introduction: availability and irrational consumption of antimicrobials prompt their inadequate use and sometimes give rise to adverse reactions. At present, these reactions represent a clinical and epidemiological problem. It is necessary to deepen into the knowledge about their characteristics in Cuba and the behavior in the course of time for the decision making process. Objectives: to characterize the adverse antimicrobial reactions reported in Cuba and to analyze the behavior of tendencies, seasonality and prognosis for 2013 and 2014. Methods: longitudinal and descriptive study of case series in a ten-year period (2003-2012). Data were taken from national pharmacovigilance databases. Results: there were registered 40 391 reports of adverse antimicrobial reactions accounting for 86.5 percent of the total number of adverse reactions. They prevailed in females (64.3 percent) and in under one-year old infants. The skin illnesses represented 47.9 percent and digestive ones 26.8 percent. Penicillin G was the most reported drug. Moderate adverse reactions prevailed (58.2 percent). Tendency was growing, seasonality was observed and prognosis was on the rise. Conclusions: the increase in the number of reports of adverse antimicrobial reactions and the anticipated rise of them is an alert to the health care system(AU)

Report on Tobacco Control for the Region of the Americas. WHO Framework Convention on Tobacco Control: 10 Years Later / Informe sobre el Control del Tabaco en la Región de las Américas. A 10 años del Convenio Marco de la Organización Mundial de la Salud para el Control del Tabaco

[Preface]. Tobacco is the only legal consumer product that kills up to half of those who use it as intended by the manufacturer. Worldwide, it kills one person every six seconds. Tobacco use is a risk factor for six of the eight leading causes of death worldwide as well as for the four most prevalent noncommunicable diseases: cardiovascular disease, cancer, chronic respiratory disease and diabetes. Global efforts on tobacco control are setting the standard for work to reduce the burden of NCD risk factors, and many of the interventions included in the WHO Framework Convention on Tobacco Control (FCTC) can be used to curb other risk factors like ultra-processed food, sugary beverages and harmful use of alcohol. The need for the full implementation of the FCTC has been documented in many international declarations, from the United Nation’s Political Declaration of the High-level Meeting of the General Assembly on the Prevention and Control of Non-communicable Diseases in 2011 to the recently approved 2030 Agenda for Sustainable Development and its 17 Sustainable Development Goals. In the 10 years since the entry into force of the FCTC, the Region of the Americas has advanced significantly in implementing tobacco control policies. Approximately half of the Region’s population is protected by measures such as smoke-free environments (49% of the population) and graphic health warnings (58%). However, other important measures, and specifically the ban on tobacco advertisement, promotion and sponsorship, cover less than a quarter of the population. Furthermore only one country has reached the level of tobacco taxes recommended by the World Health Organization. While 30 out of the 35 countries of the Region are Parties to the FCTC, only six countries have implemented at least four of the main measures of the FCTC at its highest level of achievement as established by WHO. It is a matter of grave concern that 11 Parties are yet to implement even one of these measures. Countries that have implemented comprehensive tobacco control measures have shown important decreases in the prevalence of tobacco consumption in their populations. This supports the view that Parties should progressively advance towards full implementation of the FCTC mandates and guidelines, in order to achieve a significant reduction in tobacco consumption so that in turn their populations benefit from improved health outcomes. The immediate and urgent goal is therefore to protect all populations from the epidemic of tobacco-related diseases by the full implementation of the WHO FCTC.

Diseño de un aplicativo para el registro de implantes, gestión de alertas e incidentes relacionados con productos sanitarios como herramienta para el responsable de vigilancia de productos sanitarios / Design of a computer program for the registration of implantable medical device, field safety corrective action and advers events, as a tool for medical device surveillance

Objetivo: Describir las funcionalidades de un programa informático de soporte a la actividad del responsable de vigilancia de productos sanitarios (PS). Analizar su utilidad tras un año de implantación. Método: Las etapas del proceso fueron: descripción de actividades básicas del responsable de vigilancia, definir las funcionalidades y datos a procesar, crear los formularios de registro y opciones de la herramienta SIVIPS, implantación en un hospital privado que gestiona PS, validación del programa y análisis de su utilidad al año. Resultados: Se desarrolló la herramienta SIVIPS en Acces® por farmacéuticos. Se describieron las variables básicas para todas las actividades del responsable de vigilancia de PS (registro implantes, registro de alertas, registro de incidentes con PS, incluidos los de diagnóstico in vitro) y las funcionalidades del programa. Al año de su implantación se encontraron registros de 564 implantes con la posibilidad de desglose por tipo de implante, 31 alertas con PS y 6 incidentes con PS, permitiendo el seguimiento de las actuaciones realizadas en estos casos. Conclusiones: SIVIPS® es la primera herramienta de soporte a la actividad del responsable de vigilancia de PS. Es una herramienta sencilla que permite de forma ágil el registro de alertas e incidentes con PS, así como el registro de los implantes realizados en el centro, consiguiendo mejorar la trazabilidad del PS (AU)

Objective: To describe the features of computer program to support the activity of the responsible for surveillance of medical devices. To evaluate their use after one year of implementation in a hospital. Method: The stages of the process were: description of the activities of medical devices surveillance and implant registration, definition of functionality and data processing, creation of databases, implementation in a private hospital which manages PS, validation of the program and analysis of their usefulness. Results: SIVIPS was developed using Acces®. Main variables were described for all the activities of the responsible for medical device surveillance (implants, alert, medical device incidents, including for in vitro diagnostics) and all the functionalities of the computer program. SIVIPS was introduced in a pharmacy service with one pharmacist for the management of medical devices. One year after its implementation we had registered 564 implants with a description by type of implant, 31 alerts and 6 incidents. SIVIPS allow monitoring of the actions taken in these cases. Conclusions: SIVIPS® is the first tool to support the activity of medical device surveillance. It is an easy tool that allows the registration of alerts and medical device related incidents, and registration of implants performed in the center, which will improve the traceability of the PS (AU)

Empaquetado genérico: el siguiente paso en favor del control del tabaquismo / Generic packaging: the following step in favor of smoking habit control

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The court of Justice of the European Union changes its case law on patentability of human embryonic stem cells

El 18 de diciembre de 2014, en el asunto de International Stem Cell Corporation contra Comptroller General of Patents, Design and Trade Marks (C-364/13), el Tribunal de Justicia de la Union Europea (TJUE) emitió una decisión importante en relación con el alcance de la exclusión de la patentabilidad por motivos relacionados con la moralidad, en virtud del artículo 6(2) de la Directiva sobre Biotecnología de la UE. El Tribunal hizo una distinción importante entre tecnologías de células madre embrionarias con base en óvulo humano fertilizado y aquellos con base en óvulos humanos no fecundados estimulados por partenogénesis. El TJUE consideró, en particular, que un óvulo humano: (i) que está sin fertilizar y (ii) cuya división y posterior desarrollo ha sido estimulado por partenogénesis, no es un embrión humano a tenor del artículos 6(2)© de la Directiva sobre Biotecnología de la UE, si en sí mismo no tiene la capacidad inherente de convertirse en ser humano, asunto comprobado por el órgano jurisdiccional a la luz de los conocimientos científicos actuales. Con este proceder, el Tribunal confirma su fallo anterior en el Asunto Brüstle (octubre de 2011) (AU)

On 18 December 2014, in International Stem Cell Corporation V. Comptroller General of Patents, Designs and Trade Marks (C-364/13), the Court of Justice of the European Union (CJEU) delivered an important decision regarding the scope of the exclusion from patentability on morality-related grounds under Article 6(2) of the Biotech Directive. The court made an important distinction between embryonic stem cell technologies based on fertilized human ovum and those based on unfertilised human ovum stimulated by parthenogenesis. The CJEU held, in particular, that a human ovum: (i) who is unfertilized and (ii) whose division and further development has been stimulated by parthenogenesis, is not ahuman embryo under Article 6(2)(c) of the Biotech Directive, if it in itself has not the inherent capacity of developing into a human being, this matter to be ascertained by the national court in the light of current scientific knowledge. By doing so, the Court clarified its previous ruling in Brüstle (October 2011) (AU)