102 resultados para ANVISA – National Health Surveillance Agency

em Repositório Institucional UNESP - Universidade Estadual Paulista "Julio de Mesquita Filho"


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ANVISA (National Health Surveillance Agency) has published in recent years, laws that regulate the stages of the control of plants derivatives, including tests of macro and microscopic botanical identification, phytochemical determination, tests of authenticity and purity, microbiological testing, among other parameters. All the analytical procedures of plant drugs control required by law must be based on the Brazilian Pharmacopoeia, other Pharmacopoeias recognized by ANVISA or quality control guides of plant species published by the World Health Organization (WHO). This study aimed to evaluate some pharmacognostic, phytochemical screening and microbiological control of plant species of the Brazilian cerrado, which have indicated ethnopharmacological: Byrsonima intermedia (Bi), Bauhinia holophylla (Bh) and Myrcia bella (Mb). In addition, certain parameters were determined for obtaining extracts from plants sprayed and dried. These data are important to obtain new scientific information from Brazilian plants with therapeutic potential.

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Since the nineteenth century ships have been using ballast water (BW) for safety, stability, propulsion and maneuverability, as well as to redress loss of fuel weight and water consumption, and to maintain structural stress at acceptable levels. Ballast water has been spreading many non-native species around the globe, but little is known about the extent and potential significance of ship-mediated transfer of microorganisms. The global movements of ballast water by ships create a long-distance dispersal mechanism for human pathogens that may be important in the worldwide distribution of microorganisms, as well as for the epidemiology of waterborne diseases. Only a few studies have been carried out on this subject, most of them involving ballast water containing crustacean larvae and phytoplankton. Specialized microbiological studies on these waters are necessary to avoid a repeat of what happened in 1991, when epidemic cholera was reported in Peru and rapidly spread through Latin America and Mexico. In July of 1992, Vibrio cholerae was found in the USA and the Food and Drug Administration (FDA) determined that it came from ballast water of ships whose last port of call was in South America. In Brazil, just a few studies about the subject have been performed. An exploratory study by the Brazilian National Health Surveillance Agency (Agencia Nacional de Vigilancia Sanitaria - ANVISA) found in ballast water different microorganisms, such as fecal coliforms, Escherichia coli, Enterococcus faecalis, Clostridium perfringens, coliphages, Vibrio cholerae O1 and Vibrio cholerae non-O1. Until now, Brazil has been focusing only on organisms transported to its territory from other countries by ballast water, to avoid their establishment and dissemination in Brazilian areas. Studies that can assess the probability that water ballast carries pathogenic microorganisms are extremely important, as is the examination of ships that arrive in the country. Treatment of the human infections caused by BW exists but none is completely safe and efficient.

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

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

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Pharmacovigilance is accomplished by voluntary notification of suspected adverse reactions, medication errors, and deviations from quality, by users and health professionals, through the filling in of forms that are sent to a data bank. To broaden the sources of notifications, the National Health Surveillance Agency (ANVISA), in partnership with the Regional Pharmacy Council (CRF) and Center for Health Surveillance (CVS) of each state, introduced the scheme of Notifying Pharmacies. The present study was aimed at determining the factors influencing the decision of drugstores and private pharmacies in Tatuí/SP in 2007, to join this project A descriptive, observational survey of knowledge, attitude and practice (KAP) was applied to volunteer pharmacists in the town. The results showed that the professionals are awave of pharmacovigilance, (95.24%) and have attitude (95.24%). However, practice is limited (6.0%). Based on this information we concluded that the low support of the project was due to lack of time, interest and no information about the benefits to society of such activity and a lack of support from the pharmacists' organizations. This situation is expected to change with the current introduction of a professional profile, the fusion of professional bodies and the promotion of social awareness on pharmacovigilance.

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Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES)

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Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES)

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After the discovery of ionizing radiation, its applications in various fields of science began to take significant proportions. In the case of medicine, there are the application areas in radiotherapy, diagnostic radiology and nuclear medicine. It was then necessary to create the field of radiological protection to establish the conditions necessary for the safe use of such ionizing radiation. Apply knowledge obtained during the graduation stage and in the practice of radiological protection in the areas of nuclear medicine and diagnostic radiology. In the area of nuclear medicine, tests were made in the Geiger-Muller counters (GM) and the dose calibrator (curiometer), the monitoring tests of radiation, waste management, clean of the Therapeutic room and testing the quality control of gamma-chambers. In the area of radiology, were performed tests of quality control equipment for conventional X-ray equipment and x-ray fluoroscopy, all following the rules of the National Health Surveillance Agency (ANVISA), and reporting of tests. The routine developed in the fields of nuclear medicine in hospitals has proved very useful, since the quality control of GM counters contribute to the values of possible contamination are more reliable. The control of dose calibrator enables the patient not to receive different doses of the recommended amounts, which prevents the repetition of tests and unnecessary exposure to radiation. The management of waste following the rules and laws established and required for its management. Tests for quality control of gamma chambers help to evaluate its medical performance through image. In part of diagnostic radiology, tests for quality control are performed in order to verify that the equipment is acceptable for usage or if repairs are needed. The knowledge acquired at the internship consolidated the learning of graduation course

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The purpose of this work is to provide quality control requirements and security in dental x-rays in order to obtain good quality image which allows the correct diagnosis, which reduces the dose to the patient, mainly due to the repetition of tests, and decreasing cost. The requirements apply to related activities to quality control and procedures using ionizing radiation for diagnostic imaging in dentistry by evaluating a minimum set of parameters to be tested or verified. Quality control follows the Ordinance No. 453 of the Ministry of Health of 06.01.1998, SS Resolution No. 625 of 12.14.1994 and Resolution No. 64 of the Health Surveillance Center Department of Health of Sao Paulo and National Health Surveillance Agency Ministry of Health of Brazil. This study was conducted in the city of Marilia, Sao Paulo, along with the Company P&R Consulting and Medical Physics, in a dental clinic of the University UNIMAR in the x-ray equipment used on that site. The physical parameters of the device were tested with the aid of ionization chambers to measure rates of radiation, electrometer to measure rates of time, kV and doses, radiographic films and positioning devices. Finally, this work demonstrates the need and importance of quality control, which one ensures the proper use of x-ray machines, maintaining efficiency and at the same time it reduces the risks to the patient, to the dentist and to the general public

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Pós-graduação em Medicina Veterinária - FMVZ

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Frying is a widely used method of preparing food, because it is a very fast and convenient process, and because it provides specific characteristics of color, flavor, odor, and texture, besides having great consumer acceptance. Therefore, the interest in the physiological effects that oils heated at high temperatures can cause to the human body arises. The aim of this work was to analyze the levels of frying used oil alteration in different kinds of foods served at the university restaurant at “Instituto de Biociências, Letras e Ciências Exatas” (IBILCE), in São José do Rio Preto-SP. In addition, it aims to make the restaurant aware of the good ways to fry and the commitment of providing good quality food to students and professionals of the Institute. With this purpose, determination of total polar compounds, conjugated dienoic acids, peroxide value, and fatty acid profile were analyzed. Two rapid tests were also used: 3M Fat Monitor and Oil Test kit. The results were compared with limits recommended for the disposal of oils and fats used in frying by the Brazilian Health Surveillance Agency (ANVISA), by other countries, and by other researches. Thus, it was concluded that the university restaurant provides the consumers with fried food of good quality, since none of the analyses showed results above recommended, although there is a need of improvement in the quality control of the oil used, in order to avoid unnecessary costs to the university restaurant.

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In spite of the stated Brazilian policy on medicines that their quality, effectiveness and safety should be ensured at reasonable cost, hospitals in the ANVISA Surveillance Network have been receiving notifications of technical complaints, adverse reactions and suspected therapeutic ineffectiveness (STI) of medicines. The purpose of this study was to identify the medicines notified for suspicion of therapeutic ineffectiveness, at a university hospital participating in the national Surveillance Network, and to investigate the existence of polymorphs of any of the drugs involved, by examining the literature. There were 31 notifications of STI in a period of 18 months, concerning 11 different drugs, all of which were 'similar' drugs (neither original nor licensed by originator); five of these could contain polymorphs, according to the literature. However, this does not mean that the other drugs could not contain some unknown polymorphs, more studies being needed on polymorphism, especially in the cases of reported therapeutic ineffectiveness. Therefore, tests of polymorphism should be made part of the routine quality control of the raw materials during the development of medicines and in the studies of pharmaceutical equivalence to 'reference' medicines (innovative brands). The stability test should also involve a study of polymorphism, in order to confirm the solid state stability of the drug. All these measures will assure the effectiveness of medicines, since the reproducibility in the quality of pharmaceutical products could be monitored, as well as the equivalence of each production batch with the batch selected to determine the bioequivalence with the reference brand.