Códigos sanitários municipais e a descentralização da vigilância sanitária no Estado do Rio de Janeiro / Municipal sanitary codes and the decentralization of health surveillance in the State of Rio de Janeiro

O presente artigo teve como objetivo mapear, sistematizar e analisar o avanço dos municípios do Estado do Rio de Janeiro na implementação dos parâmetros mínimos de estrutura como parte do processo de descentralização das ações de vigilância sanitária, tomando como referência o código sanitário municipal. Por meio de ofício e formulários, os códigos foram obtidos, analisados e comparados com o designado pelas normas estaduais e com o documento orientativo da Agência Nacional de Vigilância Sanitária para elaboração da Lei do Código Sanitário Municipal. De um total de 92 municípios fluminenses, apenas 33 contavam com o código sanitário. Entre esses 33 municípios, somente quatro apresentava, nos respectivos códigos, os nove capítulos recomendados pela Agência Nacional de Vigilância Sanitária. Por outro lado, 30 municípios contemplaram todas as ações designadas pela Secretaria de Estado de Saúde do Rio de Janeiro. Concluiu-se que, mesmo que os códigos sanitários atendam a suas necessidades, os municípios devem estar atentos a revisões e atualizações preconizadas pela União e pelo estado para que, além de representarem a realidade e especificidade locorregional, contemplem os avanços técnico-científicos e as normativas correntes.

The present article aimed to map, systematize, and analyze the progress of the municipalities of the state of Rio de Janeiro in implementation of the minimum structural parameters as part of the decentralization process of health surveillance actions, taking the municipal health code as reference. By means of letters and forms, the codes were obtained, analyzed and compared to what is designated by the state norms and to the orientative document from the Brazilian Health Regulatory Agency for the elaboration of the Municipal Health Code. From a total of 92 municipalities in the state of Rio de Janeiro, only 33 had a health code. Among these 33 municipalities, only four presented, in their respective codes, the nine chapters recommended by the Brazilian Health Regulatory Agency. In contrast, 30 municipalities contemplated all the actions designated by the Rio de Janeiro State Health Department. It was concluded that, even if the health codes meet their needs, the municipalities should be attentive to the revisions and updates recommended by the Union and by the state so that, besides representing the local and regional reality and specificity, they also contemplate the technical-scientific advances and the current normative.

Perfil de queixas técnicas relacionadas a seringas hipodérmicas de uso único comercializadas no Brasil após certificação compulsória / Profile of technical complaints related to single use hypodermic syringes marketed in Brazil after compulsory certification

RESUMO A certificação metrológica é uma importante ferramenta de Vigilância Sanitária. O objetivo deste estudo foi avaliar o perfil das notificações de queixas técnicas de seringas hipodérmicas realizadas no Notivisa/Anvisa (Sistema Nacional de Notificações de Eventos Adversos e Queixas Técnicas/Agência Nacional de Vigilância Sanitária) entre 2012 e 2015. As notificações foram analisadas individualmente e classificadas conforme os motivos relatados. Foram avaliadas 4181 notificações, e as queixas mais prevalentes foram: 'produto quebrado na embalagem lacrada' (22%) e 'sujidade/manchas no interior do produto/embalagem' (15,8%). Não foram observadas alterações significativas no perfil das queixas após a certificação compulsória, que, embora imprescindível, não é capaz de substituir o monitoramento pós-comercialização.

ABSTRACT Metrological certification is an important Sanitary Surveillance tool. The objective of this study was to evaluate the profile of notifications of technical complaints of hypodermic syringes performed in Notivisa/Anvisa (Sistema Nacional de Notificações de Eventos Adversos e Queixas Técnicas/Agência Nacional de Vigilância Sanitária) between 2012 and 2015. The notifications were analyzed individually and classified according to the reasons reported. 4181 notifications were evaluated and the most prevalent complaints were: 'broken product in the sealed package' (22%) and 'dirt/stains inside the product/packaging' (15.8%). There were no significant changes in the profile of the complaints after compulsory certification, which, although indispensable, is not capable of replacing post-marketing monitoring.

Regulamentação dos materiais médicos no Brasil / Medical supplies regulations in Brazil

Os produtos sob regime de vigilância sanitária classificados como "produtos para saúde" compreendem os "materiais médicos". Atos regulatórios de 1999 a 2005 foram selecionados e classificados por assunto, possibilitando discutir o perfil dessas publicações. A classificação foi conduzida avaliando cada legislação, sua ementa e texto publicado em Diário Oficial da União. Para subsidiar a discussão, propomos uma classificação em oito assuntos (temas). A partir dela, foi possível correlacionar e demonstrar a prevalência de assuntos publicados e, assim, indicar uma tendência de temas contemplados em cada ano do período avaliado. Como reflexão, entendemos que o Sistema Nacional de Vigilância Sanitária, neste caso, possui uma oportunidade de atuação única devido a seu arcabouço normativo organizado, capaz de atender a campos de atuação como registro, boas práticas, tramitações relacionadas às empresas de âmbito sanitário e pós-comercialização. No entanto, as legislações apresentadas somente terão aplicabilidade e eficiência se existir o conhecimento atualizado por parte dos profissionais de saúde das normas gerais de vigilância sanitária que apoiem processos decisórios de gestão mais eficientes, sem prejuízo da segurança da população.(AU)

Products under health surveillance classified as "products for health" comprehend the "medical supplies". Regulatory acts issued from 1999 to 2005 were selected and classified by subject enabling the discussion of these publications' profiles. The classification was made by evaluating each legislation, its agenda and the text published in the Diário Oficial da União, the government's official gazette in Brazil. To help the discussion we proposed a classification in eight subjects (themes). In this way, it was possible to correlate and demonstrate the prevalence of published subjects indicating a tendency of the themes contemplated in every year of the period under evaluation. As a reflection, we believe that in this case, there is a unique oportunity for the Brazilian Health Regulatory Agency taking action due to its organized normative framework, with applicability to fields like registration, good practices, issues related to companies in the health business and post-marketing. However, these legislation will only be applicable and efficient if there is up-to-date knowledge among the health care professionals about general health surveillance standards that support more efficient management decision-making processes, without jeopardizing the safety of the population.(AU)

Adverse events and technical complaints related to central venous catheters marketed in Brazil.

AIM: The objective of this study was to critically analyze data of the National Notification System for Adverse Events and Technical Complaints (Notivisa) related to central venous catheters, through an evaluation of the description of notifications recorded between 2006 and 2009. METHODS: NOTIFICATIONS WERE CATEGORIZED AND EVALUATED TO: (i) determine the number of adverse events and technical complaints, (ii) verify compliance with the classification criteria defined by the legislation, (iii) reclassify notifications, when necessary, in order for them to fit in with the legal definitions, (iv) verify registered companies in Brazil, (v) quantify the notifications according to the registered company and product lot, and (vi) identify the country of original of the notified product. Microsoft Excel((r)) 2010 was used to categorize and systematize the data. RESULTS: Some conceptual errors and incomplete records were found. Altogether, 228 notifications of technical complaints and 119 of adverse events were identified. Some notifications on guidewires and broken catheters were reported which led to the necessity of duplicating some medical procedures and to the occurrence of lesions/lacerations of vessels and tissue injury. Forty-seven percent of companies presented at least one notification in Notivisa and in all, 38 product lots had more than one notification. CONCLUSION: These data support a necessity for cooperation between all entities of the National Health Surveillance System to check compliance of this type of product and to properly report adverse events and technical complaints. It is also important to incorporate minimum standards for the management of technologies in health services, including in the acquisition of products and training of staff.

Adverse events and technical complaints related to central venous catheters marketed in Brazil

Aim: The objective of this study was to critically analyze data of the National Notification System for Adverse Events and Technical Complaints (Notivisa) related to central venous catheters, through an evaluation of the description of notifications recorded between 2006 and 2009. Methods: Notifications were categorized and evaluated to: (i) determine the number of adverse events and technical complaints, (ii) verify compliance with the classification criteria defined by the legislation, (iii) reclassify notifications, when necessary, in order for them to fit in with the legal definitions, (iv) verify registered companies in Brazil, (v) quantify the notifications according to the registered company and product lot, and (vi) identify the country of original of the notified product. Microsoft Excel® 2010 was used to categorize and systematize the data. Results: Some conceptual errors and incomplete records were found. Altogether, 228 notifications of technical complaints and 119 of adverse events were identified. Some notifications on guidewires and broken catheters were reported which led to the necessity of duplicating some medical procedures and to the occurrence of lesions/lacerations of vessels and tissue injury. Forty-seven percent of companies presented at least one notification in Notivisa and in all, 38 product lots had more than one notification. Conclusion: These data support a necessity for cooperation between all entities of the ...

Evaluation of medicine package inserts: a study of two cases of Pelargonium sidoides D.C. phytomedicines / Avaliação de bulas de medicamentos: um estudo de dois casos de Pelargonium sidoides DC fitoterápicos

In order for a phytotherapeutic drug be approved and sold in Brazil, it must be registered with the National Sanitary Surveillance Agency (ANVISA), where the quality, safety and efficacy of the product are carefully appraised. In addition, the drug must also meet a number of criteria one of which is the adequacy of the package inserts. Therefore, the aim of this study was to appraise the package inserts of all phytotherapeutic drugs produced using a standardized extract of Pelargonium sidoides, which were registered and available from Brazilian pharmacies. This checking was to ascertain whether these inserts fulfilled the requirements stipulated by RDC 140/03. The information required under RDC 140/03 was appraised through a previously devised standard form. Evaluation of the package inserts revealed that neither of the two brands fully met the requirements of the legislation. Manufacturer 'A' met only 37.0 percent of the requirements satisfactorily, while 16.0 percent of the information was considered unsatisfactory and 47.0 percent of the information was absent. Regarding manufacturer 'B', 64.2 percent of the analyzed requirements were considered satisfactory, while 16.0 percent were considered unsatisfactory and 19.8 percent of the information was absent. A package insert should contain information about medicine for consumers, pharmacists and doctors. However, the results obtained in this study showed that the information presented in the package insert of both medicines was unsatisfactory, and in many cases, violates the legislation.

Para que um medicamento fitoterápico seja comercializado no Brasil, este deve ser registrado junto à ANVISA, onde são avaliados todos os aspectos referentes à qualidade, segurança e eficácia do produto, além de verificar se estes atendem alguns requisitos, sendo um deles a adequação da bula. Por esta razão, neste estudo foram avaliadas as bulas de todos os fitoterápicos elaborados à base do extrato padronizado de Pelargonium sidoides, registrados e disponíveis no mercado brasileiro, com o intuito de verificar se estas atendem aos requisitos exigidos pela RDC 140/03. No presente trabalho, as informações exigidas pela RDC 140/03 foram avaliadas através de um formulário padrão previamente elaborado. Após avaliação das bulas pode ser verificado que nenhuma das duas marcas atendia por completo as exigências da legislação, sendo que o fabricante "A" atendeu apenas 37,0 por cento dos requisitos exigidos de forma satisfatória, enquanto 16,0 por cento das informações foram consideradas insatisfatórias e em 47,0 por cento as informações estavam ausentes. Com relação ao fabricante "B", 64,2 por cento dos itens analisados foram considerados satisfatórios, enquanto 16,0 por cento foram considerados insatisfatório e em 19,8 por cento as informações estavam ausentes. A bula deveria conter informações sobre o medicamento para consumidores, farmacêuticos e médicos, no entanto, os resultados obtidos neste estudo mostram que as informações apresentadas nas bulas foram insatisfatórias, e em muitos casos, violavam a legislação vigente.