Introduction:The thalidomide is probably the best-known teratogenic drug and still results in cases of severe physical deformities in children born in Brazil. Objective:To present the overall context of surveillance and pharmacovigilance of thalidomide in Brazil. Method:This article presents a narrative review of current literature concerning thalidomide regulation, policies, and pharmacovigilance in Brazil. Results:New cases of congenital abnormalities whose phenotype is compatible with thalidomide embryopathy were identified in the last ten years, while the approval of thalidomide for new indications was recently updated. The mechanisms of diagnosing thalidomide embryopathy are complex, remaining the challenge in distinguishing this condition from other congenital abnormalities. The increasing number of thalidomide users in Brazil is correlated with the occurrence of embryopathy and the real extension of the rationality of its use is largely unknown. Additionally, our pharmacovigilance and surveillance systems are predominantly based on voluntary reports, issues that remains over the years. Conclusions:The policies have improved over the years to prevent the fetus from being exposed to thalidomide, and current regulation establishes rules for controlling its distribution, prescription, dispensation, and use. Brazilian surveillance system is manual and pharmacovigilance is supported by voluntary reports. The failure of the system to properly control the thalidomide use and its effects might lead to serious consequences to the community; therefore, this subject deserves constant attention.
Introduction: The hygienic and sanitary conditions of vessels carrying passengers and cargo requires constant diagnosis and monitoring for disease prevention. Objective: The objective of this study was to identify health hazards in food preparation conditions and water potability in mixed vessels in the State of Amazonas-Brazil. Method: 33 vessels were analyzed with qualitative detection analysis of Escherichia coli by chromogenic substrate for water potability and environmental evaluation with questionnaire application. Results: There was microbiological contamination in 13 (39.39%) drinking water samples and 31 (93.93%) sink samples for E. coli. The structural and operational conditions of kitchen handlers mostly did not meet the minimum percentages of safety in food production. Conclusions: This is the first report on the structural and operational conditions of food preparation in mixed vessels in Manaus-AM and we conclude that intervention is necessary with public policies regarding hygienic and sanitary issues involving the supply of water served in vessels for the protection of passenger health and training of food handlers and inspection of environments.
Introdução: A atuação da vigilância sanitária nos municípios, estados e no Distrito Federal foi estabelecida por meio de códigos de saúde, regulamentados por decretos e leis. Objetivo: Realizar um diagnóstico situacional quanto à composição e à estrutura organizacional nas 27 unidades federadas que compõem o Sistema Nacional de Vigilância Sanitária (SNVS), por meio da análise da legislação sanitária vigente. Método: Foi realizado um estudo qualitativo dos regramentos jurídicos, por meio de buscas ativas desses documentos, sendo estes analisados quanto a atributos correlacionados à ação da Vigilância Sanitária. Resultados: Observou-se que cerca de 30,0% foram publicados antes da Constituição de 1988, mas há regramentos mais recentes, como os do Piauí, do Rio Grande do Norte e do Distrito Federal, publicados na década de 2010. Observou-se que 88,9% dos regramentos abrangem ações integradas ao sistema de saúde, como assistência à saúde, vigilância epidemiológica, vigilância ambiental e saúde do trabalhador. Outros atributos se mostraram pouco presentes nos regramentos, como: os referentes às competências da rede laboratórios de saúde pública (48,1%), ao gerenciamento dos fatores de riscos (22,2%), ao financiamento (33,3%) e às taxas de fiscalização sanitária (18,5%). Conclusões:As legislações estaduais e do Distrito Federal estão amparadas em normas generalistas, que não mais atendem aos anseios da sociedade contemporânea nem a realidade dos determinantes e condicionantes de saúde de seu território. Portanto, verifica-se a necessidade de harmonização e modernização desses regramentos jurídicos, com a promoção de novos arcabouços jurídicos, capazes de produzir a segurança e a efetividade das ações de vigilância sanitária praticadas em cada território.
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