Especialidades farmacêuticas sem registro sanitário válido recomendadas em Protocolos Clínicos e Diretrizes Terapêuticas
Data
2024-08-21
Autores
Dias, Ana Carolina Scalize 
Orientadores
Melo, Daniela Oliveira de
Tipo
Trabalho de conclusão de curso
Título da Revista
ISSN da Revista
Título de Volume
Resumo
Introdução: Utilizados como documentos norteadores para a universalização do cuidado terapêutico, os Protocolos Clínicos e Diretrizes Terapêuticas (PCDT) são elaborados a partir de evidências e revisões críticas da literatura científica com objetivo de instruir a tomada de decisão e delimitar os possíveis tratamentos de uma enfermidade disponíveis no Sistema único de Saúde (SUS). Contudo, devido à sua falta de atualização periódica, alguns PCDT preconizam especialidades farmacêuticas que não estão disponíveis para utilização, haja vista a caducidade de seu registro frente à Agência Nacional de Vigilância Sanitária (Anvisa). Objetivo: Identificação de especialidades farmacêuticas recomendadas em PCDT cujo registro sanitário esteja caduco na Anvisa. Materiais e Métodos: Listagem e coleta de dados sobre o status de registro de todos os medicamentos recomendados em PCDT vigentes, com a Portaria publicada até 03/12/2022. Os dados para análise dos resultados foram coletados no período de 12 de outubro de 2023 a 10 de dezembro de 2023. Os dados coletados foram registrados por duas equipes e um terceiro revisor independente resolveu as discrepâncias, sendo posteriormente analisados utilizandose planilhas através da plataforma Microsoft Excel®. Resultados: Foram analisados 101 PCDT, dos quais 54 (53,5%) dos recomendavam pelo menos uma especialidade farmacêutica com o registro caduco. Das 532 especialidades farmacêuticas recomendadas, 65 (12,2%) dos medicamentos recomendados estavam com seu registro caduco na Anvisa durante o período de pesquisa. Contudo, em todos os PDCT, sempre havia pelo menos uma outra alternativa terapêutica recomendada para o tratamento. Discussão: Metade dos PCDT vigentes no país recomendavam ao menos um medicamento com registro caduco, o que é preocupante porque pode levar a problemas de implementação e de descrédito em relação ao documento. Isso pode ser resultado da decisão de que os PCDT sejam publicados como legislação, o que impossibilita sua atualização de forma regular e simples, demandando maior burocracia para realizar ajustes como a exclusão de uma das especialidades farmacêuticas recomendada. Também chama a atenção que há total independência entre o registro sanitário e a recomendação de uma especialidade farmacêutica em PCDT, o que dificulta a monitorização para que mudanças no registro sanitário levem à atualização no conteúdo dos PCDT. Conclusão: Demonstrase que há muitos PCDT recomendando especialidades farmacêuticas com registro caduco e a necessidade de novas estratégias para facilitar ajustes na lista de medicamentos recomendados para garantir que o documento se mantenha útil para planejamento do cuidado no SUS.
Introduction: Used as guiding documents for the universalization of therapeutic care, the Clinical Protocols and Therapeutic Guidelines (PCDT) are drawn up based on evidence and critical reviews of scientific literature with the aim of instructing decision-making and delimiting the possible treatments for a disease available in the Unified Health System (SUS). However, due to their lack of regular updating, some PCDTs recommend pharmaceutical specialties that are not available for use, given the expiry of their registration with the National Health Surveillance Agency (Anvisa). Objective: Identification of pharmaceutical specialties recommended in PCDT whose sanitary registration has expired at Anvisa. Materials and Methods: Listing and collecting data on the registration status of all drugs recommended in current PCDT, with the Ordinance published until December 3, 2022.The data for analyzing the results was collected from October 12, 2023 to December 10, 2023. The data collected was recorded by two teams and a third independent reviewer resolved the discrepancies, which were then analyzed using spreadsheets on the Microsoft Excel® platform. Results: 101 PCDT were analyzed, of which 54 (53.5%) recommended at least one pharmaceutical specialty with expired registration. Of the 532 pharmaceutical specialties recommended, 65 (12.2%) of the recommended drugs had expired registration with Anvisa during the research period. However, in all the PDCT, there was always at least one other therapeutic alternative recommended for treatment. Discussion: Half of the PCDT in force in the country recommended at least one drug with expired registration, which is worrying because it could lead to implementation problems and discrediting of the document. This may be a result of the decision to publish PCDT as legislation, which makes it impossible to update them regularly and easily, requiring more bureaucracy to make adjustments such as excluding one of the recommended pharmaceutical specialties. It is also noteworthy that there is total independence between health registration and the recommendation of a pharmaceutical specialty in a PCDT, which makes it difficult to monitor whether changes in health registration lead to updates in the content of PCDT. Conclusion: Many PCDT are recommending pharmaceutical specialties that have expired and there is a need for new strategies to facilitate adjustments to the list of recommended medicines to ensure that the document remains useful for planning care in the SUS.
Introduction: Used as guiding documents for the universalization of therapeutic care, the Clinical Protocols and Therapeutic Guidelines (PCDT) are drawn up based on evidence and critical reviews of scientific literature with the aim of instructing decision-making and delimiting the possible treatments for a disease available in the Unified Health System (SUS). However, due to their lack of regular updating, some PCDTs recommend pharmaceutical specialties that are not available for use, given the expiry of their registration with the National Health Surveillance Agency (Anvisa). Objective: Identification of pharmaceutical specialties recommended in PCDT whose sanitary registration has expired at Anvisa. Materials and Methods: Listing and collecting data on the registration status of all drugs recommended in current PCDT, with the Ordinance published until December 3, 2022.The data for analyzing the results was collected from October 12, 2023 to December 10, 2023. The data collected was recorded by two teams and a third independent reviewer resolved the discrepancies, which were then analyzed using spreadsheets on the Microsoft Excel® platform. Results: 101 PCDT were analyzed, of which 54 (53.5%) recommended at least one pharmaceutical specialty with expired registration. Of the 532 pharmaceutical specialties recommended, 65 (12.2%) of the recommended drugs had expired registration with Anvisa during the research period. However, in all the PDCT, there was always at least one other therapeutic alternative recommended for treatment. Discussion: Half of the PCDT in force in the country recommended at least one drug with expired registration, which is worrying because it could lead to implementation problems and discrediting of the document. This may be a result of the decision to publish PCDT as legislation, which makes it impossible to update them regularly and easily, requiring more bureaucracy to make adjustments such as excluding one of the recommended pharmaceutical specialties. It is also noteworthy that there is total independence between health registration and the recommendation of a pharmaceutical specialty in a PCDT, which makes it difficult to monitor whether changes in health registration lead to updates in the content of PCDT. Conclusion: Many PCDT are recommending pharmaceutical specialties that have expired and there is a need for new strategies to facilitate adjustments to the list of recommended medicines to ensure that the document remains useful for planning care in the SUS.