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Repercussões e posicionamentos frente ao desabastecimento da L-Asparaginase no período de 2017 e 2018.
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Título
Repercussões e posicionamentos frente ao desabastecimento da L-Asparaginase no período de 2017 e 2018.
Tipo de documento
Resumo
Descrição
Resumo publicado no Jornal de Assistência Farmacêutica e Farmacoeconomia (JAFF)
Fonte
JAFF
Ano de publicação
2019
Referência (Vancouver)
Rocha JS, Araújo PS, Evangelista TO, Couto FA, Bomfim MK, Lima YOR, Souto AC, Costa EA. Repercussões e posicionamentos frente ao desabastecimento da L-Asparaginase no período de 2017 e 2018. J Assist Farmac Farmacoecon. 2019;4(Suppl 1).
Identificador
2019JAFF101
Title
Implications and Stakeholder Positions Regarding the Shortage of L-Asparaginase During the Period of 2017 and 2018
Document type
Abstract
Description
Abstract published in the Journal of Pharmaceutical Care and Pharmacoeconomics (JAFF)
Source
JAFF
Publication year
2019
Reference (Vancouver)
Rocha JS, Araújo PS, Evangelista TO, Couto FA, Bomfim MK, Lima YOR, Souto AC, Costa EA. Repercussões e posicionamentos frente ao desabastecimento da L-Asparaginase no período de 2017 e 2018. J Assist Farmac Farmacoecon. 2019;4(Suppl 1).
Identifier
2019JAFF101
Resumo
Introdução: A L-asparaginase, droga que trata câncer hematológico, sofreu desabastecimento em hospitais públicos do Brasil. A tentativa do Ministério da Saúde (MS) em repor os estoques surtiram críticas e repercussões na mídia, Agência Nacional de Vigilância Sanitária (ANVISA), MS, Legislativo e nas Associações Brasileiras de Oncologia. OBJETIVO:Identificar e discutir o posicionamento de atores sociais frente aos desdobramentos da aquisição da L-asparaginase no período de 2017-2018. Metodologia: Estudo integra o Observatório de Análise de Política em Saúde (OAPS) do Eixo temático Políticas de Medicamentos, Assistência Farmacêutica e Vigilância Sanitária do ISC/UFBA em parceria com a UNEB. Foram usados dados do banco de notícias do OAPS veiculadas em 2017-2018 pelo MS, ANVISA, Câmara de Deputados e entidades representativas da saúde. As notícias foram organizadas e posteriormente discutidas. Resultado e Discussão: Diante da indisponibilidade e desabastecimento da L-asparaginase no mercado brasileiro, o MS decidiu adquiri-la por cotação internacional – critério menor preço, vencendo um laboratório farmacêutico chinês. Tal decisão produziu matéria, na qual o programa Fantástico, da Rede Globo de Televisão, denunciava, com laudo técnico, presença de impurezas no medicamento da referida empresa chinesa. O MS contestou as acusações e demonstrou laudos de 6 laboratórios atestando a segurança e eficácia da L-asparaginase chinesa. A ANVISA esclareceu que realiza análise documental prévia à autorização da importação. O legislativo exigiu esclarecimentos ao MS, que justificou suas decisões sobre a troca de laboratório. O Ministério Público impetrou ação civil baseado na matéria divulgada pelo Fantástico e no depoimento de especialistas médicos e pediu o recolhimento dos lotes do medicamento chinês. A Justiça Federal, via liminar, proibiu a compra da droga pelo SUS. As sociedades de oncologia deram pareceres desfavoráveis ao medicamento alegando possíveis riscos à saúde. O Legislativo fomentou interesse em fiscalizar os atos do Poder Executivo. O MS, responsável por planos e políticas públicas para promoção, proteção, prevenção e assistência à saúde, informou sobre suas decisões à mídia e reviu a compra da droga. O desabastecimento da L-asparaginase persiste. Conclusão: Repercussões do caso mostrou conflitos entre os poderes, as necessidades de saúde pública a prática médica e revelou interesses do mercado e das indústrias em detrimento às necessidades da população.
Notas
O registro foi originalmente publicado em português. A versão em inglês foi traduzida com o apoio de inteligência artificial.
Abstract
Introduction: Health litigation is a significant factor to consider in the implementation of health policies within the Unified Health System (Sistema Único de Saúde, SUS), as judicial intervention affects the management of the healthcare sector, particularly in granting health products, services, and medications. The Defensoria Pública (Public Defender's Office) of the State of Sergipe, through its Health Litigation Resolution Chamber, ensures the population's right to health by securing access to public health products, services, medications, and available therapeutic alternatives. Understanding the profile of these judicial demands can assist in planning and executing public policies within SUS. Objectives: To understand the profile of health litigation demands in the state of Sergipe. Methods: A cross-sectional study was conducted from January to December 2021 at the Health Litigation Resolution Chamber of the Defensoria Pública of Sergipe. The chamber comprises public defenders, physicians, nurses, and pharmacists. Data from the Health Litigation Resolution Chamber database were evaluated, and the following variables were extracted: procedures, products, medications requested, number of requests standardized in SUS, and number of litigations. Data were tabulated using Microsoft Office Excel® and expressed through descriptive statistics. Results: A total of 356 requests were received, including medications, procedures, consultations, supplies, orthotics/prosthetics, nutritional supplements, and diapers. The most requested items were procedures (n=130, 36.51%) and medications (n=70, 19.66%). A small percentage of requests were standardized in SUS (n=19, 5.33%), and less than half of the administrative processes were litigated (n=177, 49.71%). Conclusion: The profile of health litigation demands in Sergipe displayed heterogeneous characteristics, with a higher prominence of requests related to health products and services. Consequently, the Health Litigation Resolution Chamber managed to prevent the filing of lawsuits and healthcare expenditures in the majority of cases. Understanding these characteristics contributes to the enhancement of planning and management of SUS flows and processes.Introduction: L-asparaginase, a drug used in hematologic cancer treatment, faced shortages in Brazilian public hospitals. Efforts by the Ministry of Health to replenish stocks sparked criticisms and significant media coverage, involving the National Health Surveillance Agency (ANVISA), the legislature, and Brazilian oncology associations. Objective: To identify and discuss the positions of social actors regarding the developments in the acquisition of L-asparaginase during the period of 2017-2018. Methodology: This study is part of the Health Policy Analysis Observatory (OAPS) focusing on Medicines Policies, Pharmaceutical Assistance, and Health Surveillance at ISC/UFBA in collaboration with UNEB. Data from news sources covering statements by the Ministry of Health, ANVISA, the Chamber of Deputies, and health-related entities during 2017-2018 were analyzed and organized for discussion. Results and Discussion: Faced with the unavailability and shortage of L-asparaginase in the Brazilian market, the Ministry of Health decided to procure it through international bidding, selecting a Chinese pharmaceutical company based on the criterion of lowest price. This decision led to a report by the Fantástico program of Rede Globo Television, alleging the presence of impurities in the Chinese-manufactured drug, which the Ministry of Health contested by presenting safety and efficacy reports from six laboratories. ANVISA clarified its role in conducting pre-importation document analysis. The legislature demanded explanations from the Ministry of Health, which justified its decisions regarding the change in suppliers. The Public Prosecutor's Office filed a civil action based on the Fantástico report and expert testimonies, seeking the recall of batches of the Chinese medication. The Federal Court issued a preliminary injunction prohibiting the purchase of the drug by SUS. Oncology societies expressed concerns about potential health risks associated with the medication. Legislative bodies expressed interest in overseeing the actions of the Executive Branch. The Ministry of Health, responsible for public health plans and policies, communicated its decisions to the media and reconsidered the procurement of the drug. However, the shortage of L-asparaginase persists. Conclusion: The repercussions of this case revealed conflicts between branches of government, the healthcare needs of the public, medical practices, and highlighted market interests conflicting with public health priorities.
Notes
The record was originally published in Portuguese. The English version was translated with the support of artificial intelligence.