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Previous issue date: 2013 === O homem encontra-se exposto a inúmeros produtos tecnológicos, e dentre eles os medicamentos, com riscos cada vez mais próximos do imponderável. Duas áreas, com ampla inclusão em vários campos do conhecimento, permeiam o ambiente dos laboratórios envolvidos no monitoramento da qualidade e do risco destes produtos. Estas são a metrologia e o risco. O presente trabalho foi relacionado ao estudo do risco de realizar ensaios em medicamentos e gerar resultados com confiabilidade analítica duvidosa em laboratórios que prestam serviço ao Sistema Nacional de Vigilância Sanitária (SNVS). O objetivo principal deste trabalho foi discutir as bases para uma política de controle do risco potencial (RP) no âmbito do componente laboratorial (CL) do SNVS. Então, foram identificados os elementos que interferiram na implantação e manutenção das medidas de controle do risco; elaborada uma ferramenta para determinação de RP; calculado o RP em amostras do CL do SNVS; estabelecidas as classes dos riscos; e descrito um cenário nacional baseado em RP. Um total de 167 Indicadores de Controle do Risco (ICR) foram identificados e incluídos na ferramenta desenvolvida. Esta se mostrou bastante útil e aplicável ao ambiente laboratorial do SNVS, além de identificar as categorias das causas que interferiram nos mecanismos de controle do risco em cada unidade laboratorial. Foram estabelecidas as faixas de aceitação das classes dos riscos: intrínsecos, aceitáveis, toleráveis e inaceitáveis. Como resultado da avaliação de RP dos 12 laboratórios amostrados situados nas regiões sul, sudeste, nordeste e centro-oeste do Brasil, 03 deles resultaram com RP tolerável, 05 com RP no nível aceitável, e 04 com RP intrínseco. Ao final da avaliação foi possível verificar que o ambiente do CL do SNVS não está homogêneo em termos de RP, já que foram identificados 3 agrupamentos de laboratórios: os que encontravam-se nas regiões de RP tolerável, aceitável e intrínseco... === Humans are exposed to numerous technological products, and among them are the drugs, with risks increasingly closer imponderable. Two areas, with wide inclusion in various fields of knowledge, permeate the environment of laboratories involved in monitoring the quality and the risk of these products. These are the metrology and risk. This research was related to the study of the risk of testing medicines, and generation of results with doubtful analytical reliability in laboratories that provide services to the Brazilian Health Surveillance System (BHSS). The main objective of this paper was discuss the basis for a policy Potential Risk (PR) applied to the laboratory component (LC) of BHSS. So, were identified the elements that influenced the implementation and maintenance of risk control procedures, developed a tool for determinate the PR; calculated the PR in samples from LC of BHSS; established the classes of risk, and described the national scenario based on PR. A total of 167 Risk Control Indicators (RCI) were identified which were included in the tool developed. It proved quite useful and applicable to the laboratory environment of BHSS, besides identified the categories of causes that interfered with the mechanisms of risk control in each laboratory. Was defined the acceptance ranges of classes intrinsic risk, acceptable, tolerable and unacceptable. As a result of the evaluation of PR sampled from 12 laboratories, located in the south, southeast, northeast and center-west of Brazil, 03 of them resulted as tolerable PR, 5 as acceptable level, and 4 as intrinsic PR. At the end of the evaluation was possible to verify that the environment of the LC of BHSS is not homogeneous in terms of PR, because were identified 3 groups of laboratories: those who were in the regions of tolerable, acceptable and intrinsic PR. The scenario was described by the Risk Breakdown Structure (RBS) and graphics radar type, for making it possible to display all elements sampled. The complexity and also the risk that exist in laboratories providing service to BHSS, was characterized, either conducting fiscal analysis in suspected samples of sanitary infraction with low predictability of which one will be tested, or during the tests for monitoring the quality of drugs. It was possible identify the RCI which showed relationship between analytical reliability and the causes: technical, external, organizational and management, that could avoid the failure indicator. It was the proficiency test. Therefore, it was suggested to evaluate the possibility of establishing compulsory laboratories participating in Proficiency Testing Programs with pre-established frequency.
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