Avaliação dos medicamentos injetáveis encaminhados ao INCQS no período de janeiro de 2000 a junho de 2006 pelas vigilâncias sanitárias municipais, estaduais e ANVISA

Autor: Souto, Claudia Ribeiro
Rok vydání: 2008
Předmět:
Zdroj: Repositório Institucional da FIOCRUZFundação Oswaldo CruzFIOCRUZ.
Druh dokumentu: masterThesis
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Fundação Oswaldo Cruz. Instituto Nacional de Controle de Qualidade em Saúde
O Instituto Nacional de Controle de Qualidade em Saúde (INCQS) - FIOCRUZ é responsável pela realização das análises fiscais de todos os medicamentos injetáveis apreendidos pelas vigilâncias sanitárias estaduais, municipais e ANVISA. Estes medicamentos destinam-se à administração parenteral e são amplamente utilizados. Diante do risco associado ao uso destes medicamentos, o quesito esterilidade torna-se imprescindível, pois a presença de qualquer microrganismo vivo pode ser responsável pela ocorrência de infecções mais sérias. O objetivo deste trabalho é avaliar os medicamentos injetáveis encaminhados ao INCQS no período de janeiro de 2000 a junho de 2006, na modalidade fiscal, advindos da demanda espontânea das vigilâncias sanitárias municipais, estaduais e ANVISA, submetidos ao ensaio de esterilidade.
Background: The National Institute of Quality Control in Health – Fiocruz (INCQS) is responsible for fiscal analysis of all injectable drugs collected by local and federal sanitary surveillance agencies. These drugs are widely prescribed for intravenous use and sterility is paramount, once the presence of any living microorganism can raise the risk of infections. The purpose of this study is to evaluate the injectable drugs process sent to INCQS for fiscal analysis by municipal and state sanitary surveillance and the federal agency, from January 2000 to June 2006, submitted to sterility test. Methods: A survey was conducted using the Sample Management System (SGA). For bivariate analysis, being able for analysis and the final conclusion of the analytical report were considered dependent variables. For categorical variables the respective proportions and confidence intervals of 95% were calculated. Statistical significance was tested by chi-squared test. Data was entered in Epi Info v. 3.3.2 and analysed in SPSS 8.0. Results: Three hundred and sixty injectable drugs were eligible for the study and 297 were analysed. The main reason for not analyzing the remaining 63 drugs was the presence of irregularities in the moment of apprehension. The middle-west region had the best performance, with 95% of the drugs analysed. Thirty-eight drugs (12,8%) were disapproved; the principal reason was the label analysis, mainly from central nervous system drugs. Conclusions: The small proportion of drugs disapproved in the sterility test and in the final analytical report indicates that Brazilian population, except those who live in the North region, is using safe and effective injectable drugs.
Databáze: Networked Digital Library of Theses & Dissertations
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