1000 resultados para Legislação de Medicamentos


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The presence of cyanobacterial blooms in reservoirs intended for supply to the population can create public health problems for many species could produce potentially toxic compounds and these are not eliminated in the conventional procedures used in water treatment plants. So even in amounts less than the maximum allowable limit imposed by MS, cyanotoxins can be present in drinking water distributed to the population, creating a chronic exposure. There is little information about the long-term effects of oral exposure to cyanotoxins. This work aimed to show the exposure orally (v.o) of animals to a crude extract of cyanobacteria containing cyanotoxins to evaluate the reproductive performance of pregnant rats and their offspring and fertility of male rats. The presence of microcystins (MCs) in samples collected during the flowering processes in freshwater reservoirs in the Rio Grande do Norte, was analyzed by enzyme immunoassay and its variants have been identified and quantified by chromatographic methods. It was observed that by administration v.o. cyanobacterial extract containing MCs (40, 100 or 250 ng of MCs / kg / day) did not cause systemic toxicity in adult rats or effect on reproductive performance of male and female rats treated. It was also not observed any changes in skeletal study in the offspring of pregnant rats treated with the extract above. Because the solutions used contained MCs in a concentration equal to or greater than the tolerable daily intake for MCs, the results suggest, therefore, that the development of this work contributed to better assess public health risk as the oral exposure to cyanotoxins, increasing thus the credibility of the maximum allowable limit (LMP) of MCs in drinking water distributed to the population of several countries that use the LMP established by WHO in its legislation

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The 1988 Federal Constitution of Brazil by presenting the catalog of fundamental rights and guarantees (Title II) provides expressly that such rights reach the social, economic and cultural rights (art. 6 of CF/88) as a means not only to ratify the civil and political rights, but also to make them effective and practical in the life of the Brazilian people, particularly in the prediction of immediate application of those rights and guarantees. In this sense, health goes through condition of universal right and duty of the State, which should be guaranteed by social and economic policies aimed at reducing the risk of disease and other hazards, in addition to ensuring universal and equal access to actions and services for its promotion, protection and recovery (Article 196 by CF/88). Achieving the purposes aimed by the constituent to the area of health is the great challenge that requires the Health System and its managers. To this end, several policies have been structured in an attempt to establish actions and services for the promotion, protection and rehabilitation of diseases and disorders to health. In the mid-90s, in order to meet the guidelines and principles established by the SUS, it was established the Política Nacional de Atenção Oncológica PNAO, in an attempt to sketch out a public policy that sought to achieve maximum efficiency and to be able to give answers integral to effective care for patients with cancer, with emphasis on prevention, early detection, diagnosis, treatment, rehabilitation and palliative care. However, many lawsuits have been proposed with applications for anticancer drugs. These actions have become very complex, both in the procedural aspects and in all material ones, especially due to the highcost drugs more requested these demands, as well as need to be buoyed by the scientific evidence of these drugs in relation to proposed treatments. The jurisprudence in this area, although the orientations as outlined by the Parliament of Supreme Court is still in the process of construction, this study is thus placed in the perspective of contributing to the effective and efficient adjudication in these actions, with focus on achieving the fundamental social rights. Given this scenario and using research explanatory literature and documents were examined 108 lawsuits pending in the Federal Court in Rio Grande do Norte, trying to identify the organs of the Judiciary behave in the face of lawsuits that seeking oncology drugs (or antineoplastic), seeking to reconcile the principles and constitutional laws and infra constitutional involving the theme in an attempt to contribute to a rationalization of this judicial practice. Finally, considering the Rational Use of health demands and the idea of belonging to the Brazilian people SUS, it is concluded that the judicial power requires ballast parameters of their decisions on evidence-based medicine, aligning these decisions housing constitutional principles that the right to health and the scientific conclusions of efficacy, effectiveness and efficiency in oncology drugs, when compared to the treatments offered by SUS

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In Brazil, social rights have always been considered secondary legal categories, whose implementation could wait for the pending of political decisions. At the end of the Second World War, International Law emphasizes the protection of human beings, raising his dignity as a legal pillar of the legal orders and one of the main foundations of Constitutions. At the post-positivism Constitutionalism, the realization of social rights receives special attention with the assumption of supremacy and normativity of the Constitutions, while the judiciary participates in the realization of democracy, not only as applicator of laws, but also as the guardian of constitutionality of the acts and administrative omissions, creatively contributing to the constitutional achievement, filling gaps and normative state omissions. In this aspect, the supply of medicines, whose costs can not be supported by the individual, keep a close connection with the right to life, health and dignity of the human being, as the subject of numerous lawsuits directed against the Public Administration. Such phenomenon has caused intense debate regarding judicial activism and legitimacy of these decisions, particularly on the need to define what are the limits and possibilities considering the principle of separation of powers and the principle of reserve of the possible; bieng this the problematic developed in this research. Thus, this research aims to verify the legitimacy of judicial decisions that determines to the Public Administration the compulsory providing of medicine to those who can not afford the cost of their treatment, as well as, contribute to the dogmatic constructions of parameters to be observed by judicial interference. Regarding the methodology, this research has an investigative and descriptive caracter and an theoretical approach based on bibliographical data collection (judicial and doutrine decisions) that received qualitative treatment and dialectical approach. As a result, it is known that the judicial decision that determines the supply of medicines to those individuals who can not afford them with their own resources is legitimate and complies with the democratic principle, not violating the principle of separation of powers and the reserve of the possible, since the judicial decison is not stripped with an uniform and reasonable criteria, failing to contain high burden of subjectivism and witch signifies a possible exacerbation of functions by the judiciary, suffering, in this case, of requirement of legal certainty. It is concluded that the Court decision that determines the government the providing of medicine to those who can not afford the cost of treatment should be based on parameters such as: the protection of human dignity and the minimum existencial principle, the inafastable jurisdiction principle; compliance critique of the possible reserve principle; subsidiarity of judicial intervention; proportionality (quantitative and qualitative) in the content of the decision; the questioning about the reasons for non-delivery of the drug through administrative via; and, finally, the attention not to turn the judiciary into a mere production factor of the pharmaceutical industry, contributing to the cartelization of the right to health

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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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Brazilian exportations come growing in a constant form in the last years, stimulated for the globalization and public politics directed toward the increase of the internal surplus. In this context the objective of this work was to investigate the perception of the shrimp exporting entrepreneurs of Rio Grande do Norte, with relation to the impact of the Brazilian environmental legislation in the companies competitiveness at the external market. From data collected from the controllers of the companies, it was used a survey methodology, with exploratory and descriptive character. The results found in this study indicate that the companies, in general way, understand that the environmental legal requirements do not confuse nor help in the search and conquest of new international markets. A little more of the half of the researched companies, does not see the legislation rigid as important factor of competitiveness. However a sufficiently significant percentage, already has a more strategical vision on the subject, or at least already it heard to speak on such possibility

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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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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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Com o objetivo de avaliar as características do consumo de medicamentos na população urbana de Araraquara, SP, Brasil, foram coletados dados, por meio de entrevistas domiciliares, de uma amostra da população que consumiu pelo menos um medicamento nos quinze dias que antecederam a data da entrevista. O estudo foi realizado no período de agosto a setembro de 1985. Verificou-se que 42,1% dos medicamentos utilizados foram adquiridos sem prescrição médica. O consumo entre o sexo feminino foi maior que para o sexo masculino. Na automedicação o grupo que apresentou taxa mais elevada, segundo a faixa etária, foi o de 50 anos e mais, com 31,6%. Grande parte do consumo de medicamentos constituiu-se dos industrializados (97,6%). As prescrições médicas, feitas em consultas anteriores, e avalia das como bem sucedidas foram retomadas em situações diversas (12,0%), revelando o importante papel que o médico desempenha na formação dos critérios de escolha dos remédios utilizados nas práticas de automedicação. O farmacêutico e/ou balconista de farmácia contribui com 10,0% dos medicamentos usados que tiveram essa via de indicação. As orientações feitas por amigos, vizinhos e parentes (9,1%) revelaram intenso circuito de trocas de socializações quanto aos quadros móbidos e indicações terapêuticas.

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The inventory management in hospitals is of paramount importance, since the supply materials and drugs interruption can cause irreparable damage to human lives while excess inventories involves immobilization of capital. Hospitals should use techniques of inventory management to perform replenishment in shorter and shorter intervals, in order to reduce inventories and fixed assets and meet citizens requirements properly. The inventory management can be an even bigger problem for public hospitals, which have restrictions on the use of resources and decisionmaking structure more bureaucratized. Currently the University Hospital Onofre Lopes (HUOL) uses a periodic replacement policy for hospital medical supplies and medicines, which involves one moment surplus stock replenishment, the next out of stock items. This study aims to propose a system for continuous replenishment through order point for inventory of medical supplies and medicines to the hospital HUOL. Therefore, a literature review of Federal University Hospitals Management, Logistics, Inventory Management and Replenishment System in Hospitals was performed, emphasizing the demand forecast, classification or ABC curve and order point system. And also, policies of inventory management and the current proposal were described, dealing with profile of the mentioned institution, the current policy of inventory management and simulation for continuous replenishment order point. For the simulation, the sample consisted of 102 and 44 items of medical and hospital drugs, respectively, selected using the ABC classification of inventory, prioritizing items of Class A, which contains the most relevant items in added value, representing 80 % of the financial value in 2012 fiscal year. Considering that it is a public organization, subject to the laws, we performed two simulations: the first, following the signs for inventory management of Instruction No. 205 (IN 205 ), from Secretary of Public Administration of the Presidency ( SEDAP / PR ), and the second, based on the literature specializing in inventory management hospital. The results of two simulations were compared to the current policy of replenishment system. Among these results are: an indication that the system for continuous replenishment reorder point based on IN 205 provides lower levels of safety stock and maximum stock, enables a 17% reduction in the amount spent for the full replenishment of inventories, in other words, decreasing capital assets, as well as reduction in stock quantity, also the simulation made from the literature has indicated parameters that prevent the application of this technique to all items of the sample. Hence, a change in inventory management of HUOL, with the application of the continuous replenishment according to IN 205, provides a significant reduction in acquisition costs of medical and hospital medicine

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This work was concerned to investigate the meaning attributed to anxiolytic drugs by women, in public health service. It proposes a joint analysis through a link between three dimensions: the woman, the drug, and public health service itself, in an hegemonic medical assistance model. It is observed that the relation between these elements has a great influence over the use and construction of a particular meaning, by the user. The medication is analysed as a consumption merchandise and as an health symbol. In this way, it reflects a biologized vision, which believes the drug as a solution for all health problems. It tries to analyse the generalized medical prescription for anxiolythics and it s consequences. It focalizes also the production and utilization of public health services by patients, mainly women. The question related to the use of anxiolytics and the meaning construted by women is analysed focusing the way that relations of masculine/feminine gender are organized in our society. At this point of view, it tries to understand the dimension that these questions have in subjectivity production, and how it acts in the health/disease process. Finally, this work tries to understand, in a broad sense, the use of anxiolytics looking at the problem not only as a biological question, but also as a cultural matter. The research was done over seventeen women, all of them anxiolytic users. It was used, as research instrument, semi-structured interview associated with methodological analysis of user s speeches

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This study aimed to apply, thermogravimetriy /derivative Thermogravimetriy (TG/DTG), differential scanning calorimetry (DSC), Differential Thermal Analysis (DTA), to conduct a comparative study on drug reference, generic and whose active principles are similar captopril hydrochlorothiazide, ampicillin, paracetamol, aspirin and mebendazole sold in local pharmacies. Samples of the active ingredients and dosage forms were also characterized by absorption infrared spectroscopy (IR), X-ray diffraction (XRD) and microscopy scanning electron (SEM). The TG / DTG curves showed a general similarity in the thermal behavior of the samples, but also showed the influence of excipients on the thermal stability. The DSC curve of the generic base hydrochlorothiazide showed no peak on the fusion of the drug due to interference of lactose as a diluent, which causes interaction with the active principle causing their degradation before the merger. The DSC curves of the drugs consisting of paracetamol showed reproducibility at the melting point of the active and the other thermal events. The DSC result of binary mixtures involving captopril / magnesium stearate and mebendazole/magnesium stearate showed possible interactions or incompatibilities evidenced by the displacement of the melting point of both drugs. The other mixtures showed no change. The infrared spectra presented were very similar, indicating the presence of functional groups characteristic of the constituents of the samples. The X-ray diffraction showed peaks indicative of crystalline structure of the active ingredients as well as some of the ingredients in the formulation of the drug and the micrographs indicate a general heterogeneity in the size distribution of particles in the samples

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The present study utilized the thermogravimetry (TG) and optical emission spectroscopy with inductively coupled plasma - ICP / OES to determine the calcium content in tablets of carbonate, citrate and calcium lactate used in the treatment of osteoporosis. The samples were characterized by IR, SEM, TG / DTG, DTA, DSC and XRD. The thermal analysis evaluated the thermal stability and physical-chemical events and showed that the excipients influence the decomposition of active ingredients. The results of thermogravimetry indicated that the decomposition temperature of the active CaCO3 (T = 630.2 °C) is lower compared to that obtained in samples of the tablets (633.4 to 655.2 °C) except for sample AM 2 (Ti = 613.8 oC). In 500.0 °C in the samples of citrate and calcium lactate, as well as their respective active principles had already been formed calcium carbonate. The use of N2 atmosphere resulted in shifting the initial and final temperature related to the decomposition of CaCO3. In the DTA and DSC curves were observed endo and exothermic events for the samples of tablets and active ingredients studied. The infrared spectra identified the main functional groups in all samples of active ingredients, excipients and tablets studied, such as symmetric and asymmetric stretches of the groups OH, CH, C = O. Analysis by X-ray diffraction showed that all samples are crystalline and that the final residue showed peaks indicative of the presence of calcium hydroxide by the reaction of calcium oxide with moisture of the air. Although the samples AM 1, AM 2, AM 3 and AM 6 in their formulations have TiO2 and SiO2 peaks were not observed in X-ray diffractograms of these compounds. The results obtained by TGA to determine the calcium content of the drugs studied were satisfactory when compared with those obtained by ICP-OES. In the AM 1 tablet was obtained the content of 35.37% and 32.62% for TG by ICP-OES, at 6 AM a percentage of 17.77% and 16.82% and for AM 7 results obtained were 8.93% for both techniques, showing that the thermogravimetry can be used to determine the percentage of calcium in tablets. The technique offers speed, economy in the use of samples and procedures eliminating the use of acid reagents in the process of the sample and efficiency results.

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This paper is set in a scenario in which higher education institutions suffer from external pressure to increase efficiency. The legislation after the Law of Directives and Bases for Education (LDBE), from 1996, is characterized by the fragmentation in its implementation, raising a concern with flexibility and innovation in several normative devices as well as aspects that must be incorporated to its organizational structure. The policies examined in this thesis are: Distance Education (DE); Law of Innovation and the Program of Support to Restructuring and Expansion of Federal Universities (PSREFU). This thesis aims to observe to what extent the characteristics of innovation and flexibility, which mark the new post- LDBE educational legislation, influence the organizational redesign of the Federal University of Ceará (UFC). For being about implementation policies, using contingency approach in order to collect the internal dynamics permeating the redesign of higher education institutions, the thesis focuses on the impacts caused by flexibility and innovation. This is a qualitative research, with case study methods, archive research and semi-structured interviews with members of the university administration. The results don t allow us to confirm the adoption of a more flexible and innovative configuration in the university but it is possible to identify the presence of those elements in the implementation changes, characterizing the hybrid structure. The changes mainly expose the extension of the management of projects to the administrative and academic components related to the institution. In terms of projection, the study found changes in the elements which characterize the current setting and the tendency of the university for adopting a diverse organizational structure. However, if the decentralization of management persists, the academic units may adopt their own structural solutions, but with no evidence of changes in the professional organization in most units. In this perspective, this thesis states that there are difficulties when incorporating innovation and flexibility to their organizational structure, which lead to improvised solutions, superposing skills through the redundancy of structures created with the same purpose or copying exogenous solutions