Judicialização por medicamentos oncológicos: a experiência do Núcleo de Apoio Técnico do estado do Tocantins (NAT-JUS - Estadual)
Data
2020-12-18
Autores
Andrade, Elizangela Braga 
Orientadores
Nakano, Luis Carlos Uta
Tipo
Tese de doutorado
Título da Revista
ISSN da Revista
Título de Volume
Resumo
O Núcleo de Apoio Técnico do Estado do Tocantins (NAT-Jus-Estadual) emite notas técnicas embasadas na política pública e evidência científica no caso concreto. A pesquisa documental exploratória foi realizada em 130 processos judiciais por medicamentos oncológicos encaminhados ao NAT-Jus-Estadual no período de 2013 a 2019. Foram analisados: presença de prescrição e relatório médicos, medicamentos mais demandados, situação de registro na na Agência Nacional de Vigilância Sanitária (ANVISA) e a existência de indicação off-label; Doenças oncológicas, estágio e finalidade do tratamento; custos do medicamento, tempo de utilização, benefícios informados nos relatórios médicos, as reações adversas e as evidências científicas; instituições que estão demandando os processos judiciais e a Decisão judicia; origem das ações judiciais quanto aos serviços de saúde e municípios de residência dos pacientes; Aspectos demográficos e sócio-econômicos dos usuários. Os (Gráficodos revelam que a Defensoria Pública Estadual respondeu por 68% dos casos. As Vara de Execuções Fiscais e Saúde de Palmas (38%), 1ª Vara da Fazenda Pública de Gurupi (21%) e 2ª Vara da Fazenda Pública de Araguaína (10%) foram as que mais solicitaram notas. Quanto ao requerente, 83 (64%) eram homens e 46(35%) mulheres. Cidades de residência mais frequentes foram Palmas 47(36%), Gurupi 21(16%) e Araguaína 20(15%). Prescrição e Relatório médicos estavam presentes em 87 (67%) processos. As unidades de saúde mais denunciadas foram: Unidades de Alta Complexidade em Oncologia (59%), consultórios particulares (14%) e o Hospital de Amor de Barretos (10%). As especialidades Oncologia e a hematologia foram as mais frequentes (88%).. Em 52% dos requerentes havia metástase em tratamento paliativo. 121(94%) dos requerentes solicitaram tratamento ambulatorial. Os exames não estavam presentes em 69(53%) das ações. Foram requeridos 74 medicamentos, por princípio ativo. Os mais frequentes foram: Abiraterona, Bicalutamida, Capecitabina, Anastrozol, Nivolumabe, Acetato de Gosserrelina, Sunitinibe, Bortezomibe, Pembrolizumabe, Enzalutamida, Fosfoetanolamina Sintética, Leucovorin, Imatinibe, Regorafenibe, Rituximabe, Ruxolitinibe, Sorafenibe e Temozolamida. Em 6 processos havia medicamentos não registrados na ANVISA e o uso “off label” foi observado em 8% dos processos. Em 61 (47%) das ações os medicamentos eram padronizados. O acesso judicial ao medicamento ocorreu em 64 processos, dos quais 44 (34%), ocorreu por meio de BACENJUD. Relatório médico e prescrição para o monitoramento do tratamento foram acostados em 21 (16%) e 13 (10%) dos processos, respectivamente. A decisão foi deferida em 88 processos. 60(46%) processos foram extintos: morte (50%) e desinteresse/localização da parte (20%). Os óbitos ocorreram em até 6 meses após o início da ação (50%). Em 43% a informação do óbito chegou aos autos em 1 mês. Muitas ações foram motivadas por medicamentos padronizados. Faltam nos autos informações do estado de saúde do paciente e os reais benefícios pretendidos com o medicamento. Dados sobre o monitoramento do tratamento e da aquisição por meio BACENJUD são escassos e frequentemente não elucidativos. Os resultados reforçam a necessidade de gestão adequada do estoque dos medicamentos nas UNACON’s, bem como de que sejam exigidos prescrição médica e relatório médico com informações robustas, na inicial e no monitoramento do processo, além de comprovações do uso dos recursos obtidos por BACENJUD.
The Tocantins State Technical Support Center (NAT-Jus-Estadual) issues technical notes/reports based on public policy and scientific evidence in the concrete/specific case (ou for a concrete case). The exploratory documentary research covered 130 legal proceedings referred to the NAT-Jus-Estadual on cancer drugs acquisition, from 2013 to 2019. The following aspects were analyzed: presence of medical prescription and report, most demanded drugs, registration status with the National Surveillance Agency (ANVISA) and the existence of an off-label indication; Oncological diseases, stage and purpose of treatment; drug costs, time of use, benefits reported in medical reports, adverse reactions and scientific evidence; institutions demanding the legal proceedings, as well as the judicial decision; the legal proceedings background regarding health services and the municipalities where applicants live; Demographic and socio-economic aspects of the patients. The results reveal that the State Public Defender was responsible for opening/conducting 68% of the cases. Technical notes were most requested by the Courts of Tax and Health executions (38%), the 1st Court of the Public Finance of Gurupi (21%) and the 2nd Court of the Public Finance of Araguaína (10%). As for the patients, 83 (64%) were men and 46 (35%) women. The most frequent cities of residence were Palmas 47(36%), Gurupi 21 (16%) and Araguaína 20(15%). Medical prescription and report were present in 87 (67%) cases. The most denounced health units were: High Complexity Units in Oncology (59%), private offices (14%) and the Hospital de Amor de Barretos (10%). The most frequent specialties involved were Oncology and hematology (88%). 52% of the applicants were under palliative treatment for metastasis. 121 (94%) of the applicants requested outpatient treatment. Diagnostic tests were not present in 69 (53%) of the actions. 74 medications were required per active ingredient. The most frequent ones were: Abiraterone, Bicalutamide, Capecitabine, Anastrozole, Nivolumab, Goserrelin Acetate, Sunitinib, Bortezomib, Pembrolizumab, Enzalutamide, Synthetic Phosphoethanolamine, Leucovorin, Imatinib, Regorafenib, Rituximab, Ruxolitinib, Sorafenib and Temozolamide. 6 legal actions demanded drugs which were not registered with ANVISA and “off label” use was observed in 8% of the cases. In 61 (47%) actions, medicines were standardized. Judicial access to the medication occurred in 64 cases, of which 44 (34%) occurred via BACENJUD. Medical report and prescription for monitoring treatment were included in 21 (16%) and 13 (10%) cases, respectively. Drug request was granted in 88 cases. 60 (46%) cases were closed mainly for death (50%) and disinterest/location of the party (20%) reasons. Deaths occurred within 6 months after the start of the action (50%). In 43% of the actions, information about death was added to the case records within a month´s time. Many actions were motivated to obtain standardized drugs. There is a lack of information on the patient's health status and the real benefits intended with the medication, on the case-files. Data on the monitoring of treatment and drug acquisition via BACENJUD are scarce and often not clarifying. The results reinforce the need for adequate management of the stock of medicines at UNACON’s, as well as the requirement for medical prescription and a more robust medical report, both at the beginning and in the monitoring of the process, in addition to evidences of the use of the resources obtained via BACENJUD.
The Tocantins State Technical Support Center (NAT-Jus-Estadual) issues technical notes/reports based on public policy and scientific evidence in the concrete/specific case (ou for a concrete case). The exploratory documentary research covered 130 legal proceedings referred to the NAT-Jus-Estadual on cancer drugs acquisition, from 2013 to 2019. The following aspects were analyzed: presence of medical prescription and report, most demanded drugs, registration status with the National Surveillance Agency (ANVISA) and the existence of an off-label indication; Oncological diseases, stage and purpose of treatment; drug costs, time of use, benefits reported in medical reports, adverse reactions and scientific evidence; institutions demanding the legal proceedings, as well as the judicial decision; the legal proceedings background regarding health services and the municipalities where applicants live; Demographic and socio-economic aspects of the patients. The results reveal that the State Public Defender was responsible for opening/conducting 68% of the cases. Technical notes were most requested by the Courts of Tax and Health executions (38%), the 1st Court of the Public Finance of Gurupi (21%) and the 2nd Court of the Public Finance of Araguaína (10%). As for the patients, 83 (64%) were men and 46 (35%) women. The most frequent cities of residence were Palmas 47(36%), Gurupi 21 (16%) and Araguaína 20(15%). Medical prescription and report were present in 87 (67%) cases. The most denounced health units were: High Complexity Units in Oncology (59%), private offices (14%) and the Hospital de Amor de Barretos (10%). The most frequent specialties involved were Oncology and hematology (88%). 52% of the applicants were under palliative treatment for metastasis. 121 (94%) of the applicants requested outpatient treatment. Diagnostic tests were not present in 69 (53%) of the actions. 74 medications were required per active ingredient. The most frequent ones were: Abiraterone, Bicalutamide, Capecitabine, Anastrozole, Nivolumab, Goserrelin Acetate, Sunitinib, Bortezomib, Pembrolizumab, Enzalutamide, Synthetic Phosphoethanolamine, Leucovorin, Imatinib, Regorafenib, Rituximab, Ruxolitinib, Sorafenib and Temozolamide. 6 legal actions demanded drugs which were not registered with ANVISA and “off label” use was observed in 8% of the cases. In 61 (47%) actions, medicines were standardized. Judicial access to the medication occurred in 64 cases, of which 44 (34%) occurred via BACENJUD. Medical report and prescription for monitoring treatment were included in 21 (16%) and 13 (10%) cases, respectively. Drug request was granted in 88 cases. 60 (46%) cases were closed mainly for death (50%) and disinterest/location of the party (20%) reasons. Deaths occurred within 6 months after the start of the action (50%). In 43% of the actions, information about death was added to the case records within a month´s time. Many actions were motivated to obtain standardized drugs. There is a lack of information on the patient's health status and the real benefits intended with the medication, on the case-files. Data on the monitoring of treatment and drug acquisition via BACENJUD are scarce and often not clarifying. The results reinforce the need for adequate management of the stock of medicines at UNACON’s, as well as the requirement for medical prescription and a more robust medical report, both at the beginning and in the monitoring of the process, in addition to evidences of the use of the resources obtained via BACENJUD.