Comissão Nacional de Incorporação de Tecnologias no Sistema Único de Saúde e a incorporação de medicamentos na Relação Nacional de Medicamentos Essenciais: um estudo transversal
Data
2022-02-03
Autores
Lima, Giovanni Alexsander Silva 
Orientadores
Silva, Antonio Távora de Albuquerque
Tipo
Trabalho de conclusão de curso
Título da Revista
ISSN da Revista
Título de Volume
Resumo
A Relação Nacional de Medicamentos Essenciais (Rename) é um instrumento estratégico para garantir o acesso da população a medicamentos essenciais e promover seu uso racional, além de guiar os profissionais de saúde na terapêutica e os gestores na aquisição de medicamentos de forma economicamente sustentável. Desde 2012, a Rename é atualizada pela Comissão Nacional de Incorporação de Tecnologias no SUS (Conitec), que passa a assessorar o Ministério da Saúde na decisão de incorporação de medicamentos no SUS através da emissão de relatórios de recomendação e pareceres técnicos. Entretanto, não foram encontrados estudos que analisassem a existência de relatórios de recomendação que embasassem, através de evidências científicas, a incorporação dos medicamentos na Rename entre 2012 e 2020. Portanto, este trabalho teve por objetivo, analisar a Rename 2020 sob a luz dos critérios estabelecidos para a Conitec para incorporação de medicamentos na mesma. Para tal, foi utilizado o seguinte método: estudo transversal que analisou a Rename 2020 com base nos relatórios de recomendação elaborados pela Conitec e nos Protocolos Clínicos e Diretrizes Terapêuticas (PCDT) do Ministério da Saúde publicados no portal oficial da Conitec. Resultados: Foi observado que, entre os anos de 2012 e 2020, 605 medicamentos foram incorporados à Rename, sendo que, 47,6% deste quantitativo refere-se aos medicamentos do Componente Especializado da Assistência Farmacêutica (CEAF). Ao todo, 437 (72,2%) medicamentos não tiveram seus Relatórios de Recomendação para incorporação à Rename identificados. Considerando a classificação Anatômico Terapêutico Químico (ATC) da Organização Mundial da Saúde (1° nível), as 3 classes com maior quantitativo de medicamentos incorporados à Rename entre os anos de 2012 e 2020, foram: J (134 medicamentos), N (94 medicamentos) e L (75 medicamentos). Foram identificados 30 medicamentos pertencentes a mais de um bloco de financiamento da Assistência Farmacêutica. E nos anos de 2018 e 2020 observou-se melhora referente a proporção de Relatórios de Recomendação identificados, frente aos não identificados. Conclusão: Não se sabe se os relatórios foram elaborados, mas não disponibilizados ao público, ou se os medicamentos foram incorporados sem qualquer avaliação pela Conitec. Observa-se ainda, grande quantidade de medicamentos do Componente Especializado da Assistência Farmacêutica (CEAF) incorporados a Rename, muitos destes sem relatórios de recomendação. Muitos medicamentos possuíam PCDTs sem que houvesse relatórios de recomendação. Por fim, nota-se que, a partir da Rename 2018, melhorou consideravelmente a proporção de relatórios de recomendação identificados para os medicamentos incorporados.
The National List of Essential Medicines (RENAME) is a strategic instrument to guarantee the population's access to essential medicines and promote their rational use, in addition to guiding health professionals in therapy and managers in the acquisition of medicines in an economically sustainable way. Since 2012, RENAME has been updated by the National Commission for the Incorporation of Technologies (in Portuguese, Comissão Nacional de Incorporação de Tecnologias - Conitec) in the Unified Health System (in Portuguese, Sistema Único de Saúde - SUS), which starts to advise the Ministry of Health on the decision to incorporate medicines into the SUS through the issuance of recommendation and technical reports. However, no studies were found that analyzed the existence of recommendation reports that supported, through scientific evidence, the incorporation of medicines into RENAME between 2012 and 2020. Therefore, this study aimed to analyze the RENAME 2020 in light of the criteria established by Conitec for the incorporation of medicines in it. For this purpose, the following method was used: a cross-sectional study that analyzed the medicines incorporated into RENAME 2020 based on the recommendation reports prepared by Conitec and the Clinical Protocols and Therapeutic Guidelines (in Portuguese, Protocolos Clínicos e Diretrizes Terapêuticas - PCDT) of the Ministry of Health, published on the Conitec website. Results: It was observed that, between 2012 and 2020, 605 medicines were incorporated into RENAME, 47.6% of which belong to the Specialized Component of Pharmaceutical Assistance. In all, 437 (72.2%) medicines did not have their Recommendation Reports for incorporation identified into Rename. Considering the Anatomical Therapeutic Chemical classification of the World Health Organization (1st level), the three classes with the highest number of medicines incorporated into Rename between 2012 and 2020 were: J (134 medicines), N (94 medicines), and L (75 medicines). A total of 30 drugs belonging to more than one list of medicines of RENAME were identified. Additionally in the years 2018 and 2020, there was an improvement regarding the proportion of identified Recommendation Reports, compared to the unidentified ones. Conclusion: It is not known whether Recommendation Reports were produced for all medicines included in RENAME, but these were not made available to the public, or if medicines without an identified Recommendation Report were incorporated without any evaluation by Conitec. There is also a large number of high-cost drugs incorporated into RENAME and many of them without Recommendation Reports. Many medicines were included in PCDTs, but did not have Recommendation Reports to guide their allocation in a specific clinical protocol. Finally, it was observed that, from RENAME 2018, the proportion of Recommendation Reports identified for the incorporated medicines has considerably improved.
The National List of Essential Medicines (RENAME) is a strategic instrument to guarantee the population's access to essential medicines and promote their rational use, in addition to guiding health professionals in therapy and managers in the acquisition of medicines in an economically sustainable way. Since 2012, RENAME has been updated by the National Commission for the Incorporation of Technologies (in Portuguese, Comissão Nacional de Incorporação de Tecnologias - Conitec) in the Unified Health System (in Portuguese, Sistema Único de Saúde - SUS), which starts to advise the Ministry of Health on the decision to incorporate medicines into the SUS through the issuance of recommendation and technical reports. However, no studies were found that analyzed the existence of recommendation reports that supported, through scientific evidence, the incorporation of medicines into RENAME between 2012 and 2020. Therefore, this study aimed to analyze the RENAME 2020 in light of the criteria established by Conitec for the incorporation of medicines in it. For this purpose, the following method was used: a cross-sectional study that analyzed the medicines incorporated into RENAME 2020 based on the recommendation reports prepared by Conitec and the Clinical Protocols and Therapeutic Guidelines (in Portuguese, Protocolos Clínicos e Diretrizes Terapêuticas - PCDT) of the Ministry of Health, published on the Conitec website. Results: It was observed that, between 2012 and 2020, 605 medicines were incorporated into RENAME, 47.6% of which belong to the Specialized Component of Pharmaceutical Assistance. In all, 437 (72.2%) medicines did not have their Recommendation Reports for incorporation identified into Rename. Considering the Anatomical Therapeutic Chemical classification of the World Health Organization (1st level), the three classes with the highest number of medicines incorporated into Rename between 2012 and 2020 were: J (134 medicines), N (94 medicines), and L (75 medicines). A total of 30 drugs belonging to more than one list of medicines of RENAME were identified. Additionally in the years 2018 and 2020, there was an improvement regarding the proportion of identified Recommendation Reports, compared to the unidentified ones. Conclusion: It is not known whether Recommendation Reports were produced for all medicines included in RENAME, but these were not made available to the public, or if medicines without an identified Recommendation Report were incorporated without any evaluation by Conitec. There is also a large number of high-cost drugs incorporated into RENAME and many of them without Recommendation Reports. Many medicines were included in PCDTs, but did not have Recommendation Reports to guide their allocation in a specific clinical protocol. Finally, it was observed that, from RENAME 2018, the proportion of Recommendation Reports identified for the incorporated medicines has considerably improved.