999 resultados para Regulação Sanitária de Medicamentos


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This work presents an analysis about the legitimation of independent regulatory commission`s rulemaking power by participation procedure. It is observed that political and administrative decentralization and fragmentation of State, with the purpose of approaching citizens and provide, more efficiently, the functions acquired by the passage of the Welfare State, leads to a deficit of legitimacy (democratic crisis), which is noticeable in the making of legal norms by directors of independent regulatory commission to regulate specific economic sector. However, we understand that this crisis stems from the observation of the contemporary world from dogmas and legal institutions of the eighteenth century, without their evolution and adaptation to the modern world. The legitimacy must be perceived as the justification of power, relation command /obedience, which, from the Modern State, has the democracy as standard. Therefore, just as the world has evolved and demanded political and administrative decentralization to accompany him, it is necessary to the development of the idea of representative democracy (formal legitimacy) to participatory democracy (legitimacy stuff). Legitimacy is not confused with the legality: as the legality is on observance to internal legal system, the "rules of play"; legitimacy, as inputs to be fed into this system, the selection of the different expectations in the environment. Nevertheless, the legitimacy will take place by legality, through introduction of rational and communicative procedures: procedures get fundamental importance because these will be the means to select the expectations to be introduced in the legal system in order to make decisions more fair, rational and qualified towards society. Thus, it is necessary to its opening to the environment for dialogue with the government. In this context, we try to make an analysis of constitutional norms based on systematic and teleological interpretation of these norms to build these arguments. According to the Constitution of 1988, participatory democracy is a result of the democratic principle (sole paragraph of art. 1 of the Constitution), and it is an expression of citizenship and political pluralism, both foundations of Republic (respectively Art. 1st, inc . V and II of the Constitution), as well as the national consciousness. From another point of view, that principle consists of an evolution in the management public affairs (principle of Republic). The right of interested participate in the rulemaking process derives both the principle of popular participation (part of the democratic principle) and the republican principle as the due process constitutional (art. 5, LIV and LV, CF/88) and the right to petition (Art . 5 °, inc. XXXIV, "a", CF/88), and it is the duty of the State not only be open to participation and encourage it. Ignoring stakeholder involvement in procedures and / or expressions compiled can be causes of invalidation of the rule of law produced by addiction of procedure, motive, motivation and/or because of the administrative act. Finally, we conclude that the involvement of stakeholders in the process of making rules within the independent regulatory commission is the legitimacy and the validity of rules; and that, despite of the expressions do not bind the decision making, they will enter the system as juridical fact, balancing the field of technical discretionary of agencies

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In the middle of modern social changes produced by globalization and capitalism, several markets have changed. States have left the direct coordination of these markets (chiefly public utility sector in the form of monopolies), introducing regulation in order to promote competition. These changes have affected natural gas industry by promoting competition as a key factor to the development and the increase of firms in this market. The regulatory reform of natural gas industry ocurred in EUA and Europe Union and it has produced its first results. In Brazilian context, Constitutional Amendment nbr. 09 and Federal Law nbr. 9.478/97 ( Petroleum Law ) opened the natural gas market to a broad range of private economic agents and they finished the monopoly over the industry before managed by Petrobras. The new regulatory framework of Brazilian natural gas industry has designed competition as a central element to the new form of managment of business and contractual relationships of this industry. Among the regulatory instruments, open access regulation in natural gas pipelines is directed to promote competition. The questions arised about its implementation in Brazilian context are studied in the present work, in which it is discussed the constitutional rules and principles are to be applied to the open access regulation within the theme of statal regulation of economy present in constitutional economic order

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Conselho Nacional de Desenvolvimento Científico e Tecnológico

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Tem sido atribuído a vários patógenos reduções na qualidade de sementes de soja. Com o objetivo de avaliar o transporte dos fungos pelas sementes provenientes de plantas de soja, artificialmente inoculadas em condições de campo com dois isolados de Colletotrichum dematium var. truncata e um isolado de Phomopsis sojae, e seu efeito sobre a qualidade sanitária e fisiológica das mesmas, quatro variedades de soja (BRS 133, MSoy 6101, Conquista e Liderança) foram manualmente semeadas no campo, e as plantas obtidas foram inoculadas com C. dematium var. truncata isolado 1 e isolado 2, e P. sojae. A testemunha permaneceu sem inoculação. As sementes foram colhidas manualmente e submetidas a testes para avaliação da sanidade, teor de água, peso de 100 sementes, germinação em papel e emergência em areia. A desinfestação das sementes com hipoclorito de sódio a 1% por 3 minutos diminuiu a incidência dos patógenos nas mesmas. As sementes apresentaram uma alta infecção por Fusarium spp.. Phomopsis sojae foi encontrada em todos os tratamentos, e sua incidência nas sementes esteve relacionada com a incidência de Fusarium sp.. Há diferença na patogenicidade entre isolados de C. dematium var. truncata, sendo o isolado 1 o mais patogênico, com destaque para a variedade Liderança (25% de infecção por C. dematium var. truncata). Fusarium sp. influenciou negativamente a germinação de sementes da variedade MSoy 6101, independente do tratamento, e C. dematium var. truncata afetou negativamente a germinação das sementes das variedades Conquista e Liderança. Os valores de emergência em areia apresentaram-se significativamente superiores à germinação em papel, para as variedades MSoy 6101, Conquista e Liderança.

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Foram submetidas às contagens de colifagos, coliformes totais, coliformes fecais e de estreptococos fecais, 104 amostras de água colhidas de 8 poços rasos localizados na área urbana do Município de Jaboticabal, SP, Brasil, com a finalidade de avaliar as condições higiênico-sanitárias e de verificar as correlações existentes entre o número de colifagos e o de bactérias indicadoras de poluição fecal. Os resultados obtidos evidenciaram a ocorrência de 96 (92,3%) amostras fora dos padrões bacteriológicos de potabilidade estabelecidos pelo Ministério da Saúde, monstrando ser precárias as condições higiênico-sanitárias das águas analisadas. Os achados evidenciaram a inexistência de correlação entre o número de colifagos e os números de bactérias indicadoras de poluição fecal.

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O objetivo deste estudo foi avaliar a influência de dois tipos de bebedouros nipple e taça, utilizados na dessedentação de aves de postura e o incremento da demanda de cloro na água oferecida pelos dois tipos de bebedouros estudados. Foram realizadas as contagens de coliformes totais, coliformes fecais, Escherichia coli, estreptococos fecais e microrganismos mesófilos. Os resultados obtidos figuraram que as amostras de água dos reservatórios, de ambos os bebedouros, apresentaram-se contaminadas microbiologicamente antes de passarem pelos bebedouros. A contaminação por bactérias de poluição fecal foi maior nas amostras colhidas nos bebedouros tipo taça, assim como eles foram responsáveis por um maior acúmulo de matéria orgânica, tendo então uma elevada demanda de cloro e uma maior influência na depreciação da qualidade da água fornecida às aves. Dos dois tipos de bebedouros estudados, o tipo nipple mostrou ser o menos deletério no que concerne à qualidade da água entretanto, independente do tipo de bebedouro utilizado na dessedentação das aves, a desinfecção da água é um ato imprescindível à manutenção de sua qualidade e à eliminação de futuros patógenos.

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The attention with safety of the patients is important in the quality of the nursing and health care. In the pre-hospital care, such care is essential on site with the purpose of avoiding possible consequences to the individual, ensuring a fast and appropriate care, with improvement of the morbidity and reduction of the mortality. This medical attention is equally associated with the significant risks of adverse events and serious mistakes, which can be reduced with the awareness of the professionals, organization and quality management. It is a descriptive, transversal research, of quantitative approach, with the objective of identifying the risks for the safety of the patient during the mobile pre-hospital care under the view of the nurses, in a city of the Brazilian Northeast. The sample was formed by 23 nurses. The inclusion criteria: to have at least two years of experience and accept to participate on the research. The data collection was done in two steps, first photo collection, through the adapted method of photographic analysis, and the second with the application of questionnaire, divide in two parts: socio-professional data and digital photo punctuation instrument of the patient s safety. The majority of the nurses had an average working time in the mobile pre-hospital care of six years and six months, in the age group of 38 to 53 years old (69,56%) and with Lato sensu specialization (73,91%), being (29,41%) emergency and (29,41%) in intensive care. The (74%) have the Advance Cardiac Life Support (ACLS) and (100%) have the Pre-Hospital Trauma Life Support (PHTLS); (91, 30%) know the thematic safety of the patient. On the pictures it was observed a bigger variability of the categories (risks) where 44% of variance emerged on the first picture of the research. The pictures 4 and 9 with the average below 5 were classified as very insecure, while pictures 7 and 3 with an average above 7, very secure. On the results of risks observed for the patient s safety in the mobile pre-hospital care five categories emerged: organization and packaging of the equipment and materials, routines and specificities in the mobile pre-hospital care, risks on the management of medications, for traumas and infections. Starting from the analysis of these risks, it was proposed ten steps for the safety in the mobile pre-hospital care: 1- Identify the patient; 2- Safety related to prevention of infection; 3- Safety in the management of medications; 4- Safety and standardization of the packaging of equipment and materials; 5- Attention to the specificities of the mobile pre-hospital care; 6- Incentive and value the participation of the patient and family; 7- Promote the communication with the central of regulation; 8- Prevention of traumas and falls; 9- Protect the skin from additional injuries; 10- Understand the benefit of all the equipment in the ambulance. The multiple risks and their emerged combinations on the research indicate a variety of actions to be developed and stimulated, like the use of steps for the patient s safety in the mobile pre-hospital care which contributes with the aid and management of risks, reduction of mistakes, disabilities and death

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This study aimed to compare self-medication and domestic drug storage among undergraduate students in the areas of health and technology. This is a descriptive study of cross-sectional type and quantitative approach, conducted in a Public University of Natal, Rio Grande do Norte, Brazil. The sample consisted of 300 students of the third year of undergraduate courses at the Center for Health Sciences and Technology Center, selected through a simple random sample. The project was authorized by the Ethics Committee of Federal University of Rio Grande do Norte (CAAE 0137.0.051.000-10). Data collection lasted twelve months and was conducted during the period of study participants, in the university environment. The instrument for data collection was a structured questionnaire consisting of open and closed questions. For data analysis, we used descriptive statistics and applied Fisher s exact test and Chi-square test with adopted level of significance α=5% and 10%. For the variables that correlated with self-medication (p<0.05), we subsequently calculated the odds ratios and confidence intervals. The prevalence of undergraduate students who performed self-medication in the 15 days prior to the collection accounted for 33.7% and, by analyzing each knowledge area, we verified was a higher prevalence of self-medication among students in the technological area (37.3%). The analysis of the socio-demographic characteristics of the participants in this practice revealed a significant difference between the knowledge areas in the income and self-medication variables (p=0.005). General analgesics and antipyretics (N02) represent the therapy group most used in self-medication (57.4%), especially acetaminophen (28.7%), and the main health situations that motivated this practice related to pain, especially headaches (48.5%). Regarding the indication of the drugs used, the majority of students self-medicated themselves on their own (71.3%). As regards to the in-home drug storage, most of the participants had a home pharmacy (88%). By analyzing the socioeconomic characteristics, the variables medical service and home medicine presented a significant difference (p=0.002). General 10 analgesics and antipyretics constituted the medicinal products most found in the home pharmacies, especially acetaminophen. The main room used for the drug storage was the kitchen (36.4%), most students kept these products in boxes of different materials (38.6%) and the medicines stored at home of most of the participants were not easily accessible to children (75%). The results reinforce the need to develop strategies, from the reality found, aiming to encourage and implement educational and preventive activities with undergraduate students on the importance of proper self-medication and in-home drug storage. Despite the sample in our study is relatively small, not representative for the whole country, we believe that, at national level, the panorama of the subject does not present major differences

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A análise fatorial de componentes principais (CP) foi usada no exame do relacionamento entre variáveis de um banco de dados da Empresa Brasileira de Pesquisa Agropecuária (EMBRAPA) Gado de Leite. As variáveis disponíveis foram relacionadas às vacas (dias em lactação, teores lácteos de gordura e extrato seco total, produção de leite, ordem de lactação, peso vivo e grau de sangue), ao manejo (dia de pastejo, disponibilidade e períodos de descanso da pastagem), ao ambiente (estação do ano, precipitação pluviométrica) e ao alimento (consumo de nutrientes do concentrado e da cana × uréia, consumo de MS de pastagem de capim-elefante, composição química e digestibilidade in vitro da pastagem e concentração fecal de PB, FDN e FDA). O primeiro CP (33,7% da inércia dos dados) representou o uso da suplementação volumosa (cana × uréia) da pastagem em resposta à redução sazonal da disponibilidade e do consumo de capim-elefante. O segundo CP (15,3% da inércia) foi relacionado ao consumo de nutrientes do concentrado. O terceiro CP (8,5% da inércia) representou efeitos do manejo sobre a composição química da pastagem. A interpretação gráfica dos resultados favoreceu a percepção mais dinâmica da intensidade da associação e do antagonismo entre as variáveis contextualizadas no estudo.

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A Indústria Farmacêutica é uma das mais competitivas indústrias do mundo contemporâneo, e um dos seus principais desafios está na comercialização de seus medicamentos, que na sua maioria depende da prescrição médica. O objetivo deste estudo é identificar as estratégias de avaliação de desempenho utilizadas pela Indústria Farmacêutica de origem multinacional que atua no nordeste Brasileiro e o papel dos seus gerentes, para avaliar os propagandistas vendedores de medicamentos. Para tanto, buscouse reunir elementos para uma abordagem satisfatória que contemple a complexidade da temática pesquisada: Avaliação de Desempenho, Estratégias da Indústria Farmacêutica, Propaganda Médica e Competências dos Propagandistas de Medicamentos. A temática justifica-se em razão da importância estratégica dos propagandistas de medicamentos para a indústria farmacêutica, que é uma das indústrias que mais investe em pesquisa na atualidade, e contribui para melhorar a qualidade de vida e a saúde humana. A metodologia é caracterizada como um survey, de natureza quali-quantitativa. O objeto de estudo é composto pelas empresas farmacêuticas multinacionais de origem Americanas, Europeias e Asiáticas, associadas à INTERFARMA que atuam no Nordeste do Brasil. A coleta de dados foi realizada através de um questionário fechado (instrumento de pesquisa), composto por 5 perguntas fechadas que abordam a temática central dessa dissertação, 27 afirmativas para medir a concordância(escala likert) e 1 tabela contendo 46 competências, aplicado junto a gerentes da indústria farmacêutica. A análise dos dados foi feita por meio das técnicas de estatística descritiva e uma análise quantitativa para estabelecer o Ranking Médio (RM) para a parte do questionário que utilizou escala tipo Likert de 5 pontos para mensurar o grau de concordância dos respondestes. Através dos resultados desta pesquisa foi possível identificar as estratégias de avaliação de desempenho, utilizadas pelas empresas farmacêuticas, que atuam no Nordeste do Brasil, na gestão dos propagandistas vendedores de medicamentos, e identificar as competências essenciais dos propagandistas de medicamentos, na percepção dos gestores. Os resultados demonstraram que a Indústria Farmacêutica desenvolve e utiliza várias estratégias para medir e avaliar o desempenho dos propagandistas de medicamentos no Brasil, assim como em outros países, e que na percepção dos gerentes da Indústria Farmacêutica existem competências consideradas essenciais ao bom desempenho profissional dos propagandistas de medicamentos da indústria farmacêutica, contribuindo de para avanço do conhecimento deste tema

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This work uses computer vision algorithms related to features in the identification of medicine boxes for the visually impaired. The system is for people who have a disease that compromises his vision, hindering the identification of the correct medicine to be ingested. We use the camera, available in several popular devices such as computers, televisions and phones, to identify the box of the correct medicine and audio through the image, showing the poor information about the medication, such: as the dosage, indication and contraindications of the medication. We utilize a model of object detection using algorithms to identify the features in the boxes of drugs and playing the audio at the time of detection of feauteres in those boxes. Experiments carried out with 15 people show that where 93 % think that the system is useful and very helpful in identifying drugs for boxes. So, it is necessary to make use of this technology to help several people with visual impairments to take the right medicine, at the time indicated in advance by the physician

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O nitrogênio pode influenciar a qualidade das sementes de várias culturas e os seus efeitos variam com as condições ambientais e o estádio de desenvolvimento da planta em que a aplicação é realizada. Porém, pouco se sabe sobre a influência da adubação nitrogenada na qualidade de sementes da cultura do painço (Panicum miliaceum L.). O objetivo neste trabalho foi avaliar o efeito de doses e épocas de aplicação de nitrogênio em cobertura na qualidade fisiológica e sanitária de sementes de painço, cv. AL Tibagi, produzidas em condições de campo. As sementes foram produzidas no período de dezembro de 2005 a fevereiro de 2006 e as avaliações laboratoriais realizadas de março a agosto de 2006. O delineamento experimental foi de blocos ao acaso, em esquema fatorial 4 x 2, constituído pela combinação de quatro doses (0, 30, 60 e 120 kg ha-1 de N) e duas épocas de aplicação (14 e 28 dias após a emergência - DAE) do fertilizante nitrogenado (uréia) em cobertura, com quatro repetições. A aplicação de N aumentou o vigor das sementes, expresso pelos testes de envelhecimento acelerado e emergência em campo. A aplicação de nitrogênio aos 28 DAE da cultura do painço proporciona maiores IVE e porcentagem de emergência em campo. A sanidade de sementes de painço não é influenciada pelas doses e épocas de aplicação da adubação nitrogenada.

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Microbiological Control of Packaging Materials for Medicines and Cosmetics. Several consumers and official agencies, associated with the necessity of more efficient, safety and good microbiological quality packaging materials, conducted to the challenge of having packages which assure both the integrity of products and consumer's health. However, the packaging material can be an important source of microorganisms when does not fulfill the microbiological quality requirements. The objective of this work was to study the microbiological quality of different types of packaging materials for medicines and cosmetics. The microbial quality studies were conducted by analyzing representative samples by bioassay. The packing materials were analyzed for microbiological quality to verify presence of viable microorganisms. They showed the analyzed packaging materials for medicines are in agreement with RDC # 481 on 23/9/1999 of ANVISA. However, the packages to store cosmetic material are not fulfilling this RDC. The microbiological quality control of packing materials has fundamental importance for public health.

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Objective. To identify families served by the family health strategy (FHS) storing medicines at home, to evaluate storage conditions, and to investigate medicine use practices.Methods. The study was conducted in a municipality in the state of São Paulo with two FHS units serving 1 867 households. The sample was selected by means of stratified random sampling. Data collection was conducted through semistructured interviews from July to October 2008.Results. One resident was interviewed in each of the 280 households visited. Medicines were found in 255 households (91.1%). of 326 storage locations, 217 (75.8%) were inadequate (easily accessible to children or exposed to moisture, light). of the 2 578 medicines identified, 2 059 medicines (79.9%) in 236 (84.3%) households had safety or identification problems. of the 280 respondents, 179 (63.9%) used medications. of these, 24 were self-medicating, only one with an over-the-counter drug. Only 44 users had the prescription for their medication, and 21 did not follow the prescription in terms of dosage or had interrupted the treatment.Conclusions. Non-adherence to recommended treatment can lead to negative outcomes, such as inefficiency (using dosages lower than prescribed), poisoning (using dosages higher than prescribed), and other adverse reactions.

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Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP)