[Prescription of potentially inappropriate medications for the elderly: a study in Primary Health Care]. / Prescrição de medicamentos potencialmente inapropriados para idosos: um estudo na Atenção Primária à Saúde.

The elderly population is vulnerable to the risks of the use of medications, especially those considered potentially inappropriate medications (PIMs), in which the risks outweigh the benefits. The study sought to evaluate the PIMs prescribed in Primary Health Care (PHC) and associated factors. A cross-sectional, analytical study was carried out from March to December 2019 in PHC in Campina Grande, Paraíba, through interviews with 458 elderly individuals. The independent variables included socioeconomic characteristics, health status and the use of medications, and the outcome was classified as PIM by the Brazilian Consensus on Potentially Inappropriate Medications. There was a prescription of at least one PIM for 44.8% of the elderly and the majority affecting the Central Nervous System (54.4%). In the adjusted model, depression (PR=2.01; 95%CI 1.59-2.55), using other medications in addition to those prescribed (PR=1.36; 95%CI 1.08-1.72) and polypharmacy (PR=1.80; 95%CI 1.40-2.33) remained an associated factor, and self-reporting systemic arterial hypertension became a protective factor (PR=0.65; 95%CI 0.49-0.87). This reveals the need for actions to monitor closely the use of PIMs by the elderly to ensure access in conjunction with safety.

Os idosos são vulneráveis aos riscos do uso de medicamentos, principalmente daqueles considerados potencialmente inapropriados (MPI) em que os riscos superam os benefícios. O estudo buscou avaliar os MPI prescritos na Atenção Primária à Saúde (APS) e seus fatores associados. Realizou-se um estudo transversal, analítico, de março a dezembro de 2019, na APS em Campina Grande, Paraíba, através de entrevistas com 458 idosos. As variáveis independentes abrangeram características socioeconômicas, condição de saúde e utilização de medicamentos e o desfecho foi medicamento classificado como MPI pelo Consenso Brasileiro de Medicamentos Potencialmente Inapropriados. Verificou-se a prescrição de pelo menos um MPI para 44,8% dos idosos e a maioria de atuação no Sistema Nervoso Central (54,4%). No modelo ajustado, depressão (RP=2,01; IC95% 1,59-2,55), utilizar outros medicamentos além dos prescritos (RP=1,36; IC95% 1,08-1,72) e polifarmácia (RP=1,80; IC95% 1,40-2,33) permaneceram como fator associado e autorreferir ser portador de hipertensão arterial sistêmica tornou-se fator de proteção (RP=0,65; IC95% 0,49-0,87). Evidencia-se necessidade de ações que qualifiquem o uso de medicamentos por idosos, de modo a garantir acesso aliado à segurança.

Prescrição de medicamentos potencialmente inapropriados para idosos: um estudo na Atenção Primária à Saúde / Prescription of potentially inappropriate medications for the elderly: a study in Primary Health Care

Resumo Os idosos são vulneráveis aos riscos do uso de medicamentos, principalmente daqueles considerados potencialmente inapropriados (MPI) em que os riscos superam os benefícios. O estudo buscou avaliar os MPI prescritos na Atenção Primária à Saúde (APS) e seus fatores associados. Realizou-se um estudo transversal, analítico, de março a dezembro de 2019, na APS em Campina Grande, Paraíba, através de entrevistas com 458 idosos. As variáveis independentes abrangeram características socioeconômicas, condição de saúde e utilização de medicamentos e o desfecho foi medicamento classificado como MPI pelo Consenso Brasileiro de Medicamentos Potencialmente Inapropriados. Verificou-se a prescrição de pelo menos um MPI para 44,8% dos idosos e a maioria de atuação no Sistema Nervoso Central (54,4%). No modelo ajustado, depressão (RP=2,01; IC95% 1,59-2,55), utilizar outros medicamentos além dos prescritos (RP=1,36; IC95% 1,08-1,72) e polifarmácia (RP=1,80; IC95% 1,40-2,33) permaneceram como fator associado e autorreferir ser portador de hipertensão arterial sistêmica tornou-se fator de proteção (RP=0,65; IC95% 0,49-0,87). Evidencia-se necessidade de ações que qualifiquem o uso de medicamentos por idosos, de modo a garantir acesso aliado à segurança.

Abstract The elderly population is vulnerable to the risks of the use of medications, especially those considered potentially inappropriate medications (PIMs), in which the risks outweigh the benefits. The study sought to evaluate the PIMs prescribed in Primary Health Care (PHC) and associated factors. A cross-sectional, analytical study was carried out from March to December 2019 in PHC in Campina Grande, Paraíba, through interviews with 458 elderly individuals. The independent variables included socioeconomic characteristics, health status and the use of medications, and the outcome was classified as PIM by the Brazilian Consensus on Potentially Inappropriate Medications. There was a prescription of at least one PIM for 44.8% of the elderly and the majority affecting the Central Nervous System (54.4%). In the adjusted model, depression (PR=2.01; 95%CI 1.59-2.55), using other medications in addition to those prescribed (PR=1.36; 95%CI 1.08-1.72) and polypharmacy (PR=1.80; 95%CI 1.40-2.33) remained an associated factor, and self-reporting systemic arterial hypertension became a protective factor (PR=0.65; 95%CI 0.49-0.87). This reveals the need for actions to monitor closely the use of PIMs by the elderly to ensure access in conjunction with safety.

Gastos com a judicialização de medicamentos: uma revisão integrativa / Expenditure on the judicialization of medicines: An integrating review

A judicialização da saúde é um fenômeno que se iniciou no Brasil após a promulgação da Constituição Federal de 1988, que normatizou a garantia à saúde como um direito social. A quantidade de ações judiciais que requerem do Estado algum insumo ou serviço de saúde vem crescendo a cada ano, o que afeta de forma direta o financiamento da saúde. Por isso, o objetivo deste estudo foi realizar um levantamento bibliográfico acerca dos gastos com a aquisição de medicamentos via demandas judiciais. Para tanto, foi feita uma revisão integrativa a partir de pesquisa nas bases de dados Medline, Lilacs, SciELO e Scopus. Inicialmente, foram encontrados 57 estudos, sendo realizadas a apreciação dos títulos e dos resumos e a análise em pares. Ao final da busca, estaram nove artigos que tinham dados suficientes para o estudo proposto e relação com os critérios de inclusão. Os textos selecionados, em sua maioria, concentraram-se nas regiões Sul e Sudeste do Brasil, tratando principalmente da requisição de medicamentos que atuam no sistema nervoso, mas também de agentes antineoplásicos e imunomoduladores (os mais onerosos). Pôde-se perceber, ainda, que não existe uma padronização na fonte dos dados financeiros e que o gasto com a judicialização dos medicamentos é elevado: tanto os estudos de abrangência municipal e estadual, como o que apenas analisou dados da União, apresentaram valores de R$ 350 mil até R$ 219 milhões. Além disso, observou-se a baixa presença dos medicamentos pedidos judicialmente nas listas oficiais.

The judicialization of health is a phenomenon that began in Brazil after the promulgation of the Federal Constitution of 1988, which standardized the guarantee of health as a social right. The number of lawsuits that require some input or health service from the State has been growing every year, which directly affects health financing. For this reason, the objective of this study was to carry out a bibliographic survey about the expenses with the purchase of medicines via legal demands. To this end, an integrative review was carried out based on research in Medline, Lilacs, Scielo and Scopus databases. Initially, 857 studies were found, with appreciation of titles and abstracts and peer review. At the end of the search, nine articles remained that had sufficient data for the proposed study and relationship with the inclusion criteria. The selected texts were mostly concentrated in the South and Southeast regions of Brazil, dealing mainly with the requisition of medicines that act on the nervous system, but also with antineoplastic and immunomodulatory agents (the most expensive ones). It was also possible to notice that there is no standardization in the source of financial data and that the expense with the judicialization of medicines is high: both the municipal and state studies, as well as the one that only analyzed data from the Union, presented values of R$350 thousand to R$219 million reais. In addition, the low presence of the medicines requested in court was observed in the official lists.

[Judicialization of access to medicines: analysis of lawsuits in the state of Rio Grande do Norte, Brazil]. / Judicialização no acesso a medicamentos: análise das demandas judiciais no Estado do Rio Grande do Norte, Brasil.

This study aimed to analyze the lawsuits demanding access to medicines in the state of Rio Grande do Norte, Brazil, from 2013 to 2017, describing their sociodemographic, legal, and medical/health characteristics. This was a descriptive study in which the unit of analysis was the individual judicial process for requesting medicines in which the state was the defendant. The data were obtained by consulting the website of the Rio Grande do Norte Court of Justice. A total of 987 suits were analyzed, in which the majority of the plaintiffs were females (58.8%), with a mean age of 48.3 years, and residing in the state's interior (56.9%). The legal aid was predominantly public (52.8%), and 38.1% of the prescriptions originated in the private healthcare sector. Access to the medicines was obtained in 68% of the cases, and the plaintiff was responsible for the purchase in 56.1%, via attachment of public funds. Chronic noncommunicable diseases predominated, as did demands for medicines not supplied by the Brazilian Unified National Health System (SUS). A total of 1,517 medicines were requested, of which 936 (61.7%) were not on the National List of Essential Medicines (Rename). The most frequently demanded drug was insulin glargine (74 case). Of the 10 medicines with the most lawsuits, four were later incorporated by the SUS, featuring insulin analogues. The results showed that legal recourse has been consolidated as a form of access to medicines that have still not been incorporated by the SUS, which can contribute as a form of pressure for such incorporation. The attachment of public funds to comply with these rulings is worrisome for the administration of the SUS, since it jeopardizes the execution of regularly scheduled and budgeted policies in pharmaceutical assistance.

Este trabalho objetivou analisar os processos judiciais que solicitavam medicamentos ao Estado do Rio Grande do Norte, Brasil, no período de 2013 a 2017, descrevendo suas características sociodemográficas, jurídicas e médico-sanitárias. Trata-se de um estudo descritivo, cuja unidade de análise foi o processo judicial individual de solicitação de medicamentos, em que o estado é réu. Os dados foram obtidos por meio de consulta ao sítio eletrônico do Tribunal de Justiça do Estado do Rio Grande do Norte. Foram analisados 987 processos em que a maioria dos autores é do sexo feminino (58,8%), com idade média de 48,3 anos e residentes no interior do estado (56,9%). Houve predomínio de assistência jurídica pública (52,8%) e origem da prescrição no setor privado (38,1%). Em 68% dos casos, houve acesso ao medicamento, sendo o autor responsável pela compra em 56,1% deles, via bloqueio de verbas públicas. As doenças crônicas predominaram, bem como a solicitação de medicamentos não disponibilizados pelo Sistema Único de Saúde (SUS). Foram solicitados 1.517 medicamentos, dos quais 936 (61,7%) não estavam na Relação Nacional de Medicamentos Essenciais (Rename). O medicamento mais solicitado foi a insulina glargina (74 pedidos). Dos 10 medicamentos com maior número de ações judiciais, 4 foram posteriormente incorporados ao SUS, com destaque para as insulinas análogas. Os resultados mostraram que a via judicial tem se consolidado como forma de acesso a medicamentos ainda não incorporados ao SUS, o que pode contribuir como forma de pressão para a incorporação. O bloqueio de verbas públicas para o cumprimento das decisões é preocupante para o gestor do SUS, pois compromete a execução das políticas de assistência farmacêutica programadas.

El objetivo de este estudio fue analizar los procesos judiciales que solicitaban medicamentos al estado de Rio Grande do Norte, Brasil, durante el período de 2013 a 2017, describiendo sus características sociodemográficas, jurídicas y médico-sanitarias. Se trata de un estudio descriptivo, cuya unidad de análisis fue el proceso judicial individual de solicitud de medicamentos, en el que el estado es el acusado. Los datos se obtuvieron a través de la consulta a la página web del Tribunal de Justicia del Rio Grande do Norte. Se analizaron 987 procesos judiciales en los que la mayoría de los autores son del sexo femenino (58,8%), con una edad media de 48,3 años y residentes en el interior del estado (56,9%). Hubo un predominio de asistencia jurídica pública (52,8%) y origen de la prescripción en el sector privado (38,1%). En el 68% de los casos, hubo acceso al medicamento, siendo el autor responsable de la compra en un 56,1% de ellos, vía bloqueo de fondos públicos. Las enfermedades crónicas predominaron, así como la solicitud de medicamentos no puestos a disposición de los pacientes por parte del Sistema Único de Salud brasileño (SUS). Se solicitaron 1517 medicamentos, de los cuales 936 (61,7%) no se encontraban en la Relación Nacional de Medicamentos Esenciales (Rename). El medicamento más solicitado fue la Insulina glargina (74 pedidos). De los 10 medicamentos con mayor número de acciones judiciales, 4 fueron posteriormente incorporados al SUS, destacándose las insulinas análogas. Los resultados mostraron que la vía judicial se ha consolidado como forma de acceso a medicamentos todavía no incorporados al SUS, lo que puede contribuir como forma de presión para su incorporación. El bloqueo de fondos públicos para el cumplimiento de las decisiones es preocupante para el gestor del SUS, puesto que compromete la ejecución de las políticas de asistencia farmacéutica programadas.

Judicialização no acesso a medicamentos: análise das demandas judiciais no Estado do Rio Grande do Norte, Brasil / Judicialization of access to medicines: analysis of lawsuits in the state of Rio Grande do Norte, Brazil / Judicialización en el acceso a medicamentos: análisis de las demandas judiciales en el estado de Rio Grande do Norte, Brasil

Este trabalho objetivou analisar os processos judiciais que solicitavam medicamentos ao Estado do Rio Grande do Norte, Brasil, no período de 2013 a 2017, descrevendo suas características sociodemográficas, jurídicas e médico-sanitárias. Trata-se de um estudo descritivo, cuja unidade de análise foi o processo judicial individual de solicitação de medicamentos, em que o estado é réu. Os dados foram obtidos por meio de consulta ao sítio eletrônico do Tribunal de Justiça do Estado do Rio Grande do Norte. Foram analisados 987 processos em que a maioria dos autores é do sexo feminino (58,8%), com idade média de 48,3 anos e residentes no interior do estado (56,9%). Houve predomínio de assistência jurídica pública (52,8%) e origem da prescrição no setor privado (38,1%). Em 68% dos casos, houve acesso ao medicamento, sendo o autor responsável pela compra em 56,1% deles, via bloqueio de verbas públicas. As doenças crônicas predominaram, bem como a solicitação de medicamentos não disponibilizados pelo Sistema Único de Saúde (SUS). Foram solicitados 1.517 medicamentos, dos quais 936 (61,7%) não estavam na Relação Nacional de Medicamentos Essenciais (Rename). O medicamento mais solicitado foi a insulina glargina (74 pedidos). Dos 10 medicamentos com maior número de ações judiciais, 4 foram posteriormente incorporados ao SUS, com destaque para as insulinas análogas. Os resultados mostraram que a via judicial tem se consolidado como forma de acesso a medicamentos ainda não incorporados ao SUS, o que pode contribuir como forma de pressão para a incorporação. O bloqueio de verbas públicas para o cumprimento das decisões é preocupante para o gestor do SUS, pois compromete a execução das políticas de assistência farmacêutica programadas.

This study aimed to analyze the lawsuits demanding access to medicines in the state of Rio Grande do Norte, Brazil, from 2013 to 2017, describing their sociodemographic, legal, and medical/health characteristics. This was a descriptive study in which the unit of analysis was the individual judicial process for requesting medicines in which the state was the defendant. The data were obtained by consulting the website of the Rio Grande do Norte Court of Justice. A total of 987 suits were analyzed, in which the majority of the plaintiffs were females (58.8%), with a mean age of 48.3 years, and residing in the state's interior (56.9%). The legal aid was predominantly public (52.8%), and 38.1% of the prescriptions originated in the private healthcare sector. Access to the medicines was obtained in 68% of the cases, and the plaintiff was responsible for the purchase in 56.1%, via attachment of public funds. Chronic noncommunicable diseases predominated, as did demands for medicines not supplied by the Brazilian Unified National Health System (SUS). A total of 1,517 medicines were requested, of which 936 (61.7%) were not on the National List of Essential Medicines (Rename). The most frequently demanded drug was insulin glargine (74 case). Of the 10 medicines with the most lawsuits, four were later incorporated by the SUS, featuring insulin analogues. The results showed that legal recourse has been consolidated as a form of access to medicines that have still not been incorporated by the SUS, which can contribute as a form of pressure for such incorporation. The attachment of public funds to comply with these rulings is worrisome for the administration of the SUS, since it jeopardizes the execution of regularly scheduled and budgeted policies in pharmaceutical assistance.

El objetivo de este estudio fue analizar los procesos judiciales que solicitaban medicamentos al estado de Rio Grande do Norte, Brasil, durante el período de 2013 a 2017, describiendo sus características sociodemográficas, jurídicas y médico-sanitarias. Se trata de un estudio descriptivo, cuya unidad de análisis fue el proceso judicial individual de solicitud de medicamentos, en el que el estado es el acusado. Los datos se obtuvieron a través de la consulta a la página web del Tribunal de Justicia del Rio Grande do Norte. Se analizaron 987 procesos judiciales en los que la mayoría de los autores son del sexo femenino (58,8%), con una edad media de 48,3 años y residentes en el interior del estado (56,9%). Hubo un predominio de asistencia jurídica pública (52,8%) y origen de la prescripción en el sector privado (38,1%). En el 68% de los casos, hubo acceso al medicamento, siendo el autor responsable de la compra en un 56,1% de ellos, vía bloqueo de fondos públicos. Las enfermedades crónicas predominaron, así como la solicitud de medicamentos no puestos a disposición de los pacientes por parte del Sistema Único de Salud brasileño (SUS). Se solicitaron 1517 medicamentos, de los cuales 936 (61,7%) no se encontraban en la Relación Nacional de Medicamentos Esenciales (Rename). El medicamento más solicitado fue la Insulina glargina (74 pedidos). De los 10 medicamentos con mayor número de acciones judiciales, 4 fueron posteriormente incorporados al SUS, destacándose las insulinas análogas. Los resultados mostraron que la vía judicial se ha consolidado como forma de acceso a medicamentos todavía no incorporados al SUS, lo que puede contribuir como forma de presión para su incorporación. El bloqueo de fondos públicos para el cumplimiento de las decisiones es preocupante para el gestor del SUS, puesto que compromete la ejecución de las políticas de asistencia farmacéutica programadas.

Judicialization of medicines: effectiveness of rights or break in public policies?

OBJECTIVE: To analyze whether lawsuits for medicines filed against the state of Rio Grande do Norte agree with medical-sanitary and pharmaceutical assistance management criteria established by the public policies of access to medicines in force in Brazil. METHODS: This is a descriptive and retrospective study of the individual lawsuits that claimed medicines in the state of Rio Grande do Norte between 2013 and 2017. Information was collected from the procedural documents on the requested medicines, the diagnoses referred and the origin of the medical prescription, in order to analyze medical-sanitary and pharmaceutical assistance management characteristics. RESULTS: We analyzed 987 lawsuits, which requested 1,517 medications. Of these, 60.7% were not part of the National List of Essential Medicines, and, in 75% of the cases, there was a therapeutic alternative in the Brazilian Unified Health System. In 13.6% of the actions, at least one drug was prescribed for off-label use. Prescribers of philanthropic and private services often request medicines not covered by the pharmaceutical care policy. Even judicialized drugs that are part of the national list are constantly requested for non-standard indications. CONCLUSIONS: Court decisions for the supply of medicines violate health rules and make it difficult to manage pharmaceutical assistance, which may weaken the implementation of these policies.

Judicialization of medicines: effectiveness of rights or break in public policies? / Judicialização de medicamentos: efetivação de direitos ou ruptura das políticas públicas?

ABSTRACT OBJECTIVE: To analyze whether lawsuits for medicines filed against the state of Rio Grande do Norte agree with medical-sanitary and pharmaceutical assistance management criteria established by the public policies of access to medicines in force in Brazil. METHODS: This is a descriptive and retrospective study of the individual lawsuits that claimed medicines in the state of Rio Grande do Norte between 2013 and 2017. Information was collected from the procedural documents on the requested medicines, the diagnoses referred and the origin of the medical prescription, in order to analyze medical-sanitary and pharmaceutical assistance management characteristics. RESULTS: We analyzed 987 lawsuits, which requested 1,517 medications. Of these, 60.7% were not part of the National List of Essential Medicines, and, in 75% of the cases, there was a therapeutic alternative in the Brazilian Unified Health System. In 13.6% of the actions, at least one drug was prescribed for off-label use. Prescribers of philanthropic and private services often request medicines not covered by the pharmaceutical care policy. Even judicialized drugs that are part of the national list are constantly requested for non-standard indications. CONCLUSIONS: Court decisions for the supply of medicines violate health rules and make it difficult to manage pharmaceutical assistance, which may weaken the implementation of these policies.

RESUMO OBJETIVO: Analisar se as demandas judiciais por medicamentos movidas contra o estado do Rio Grande do Norte estão de acordo com critérios médico-sanitários e de gestão da assistência farmacêutica estabelecidos pelas políticas públicas de acesso a medicamentos vigentes no Brasil. MÉTODOS: Foi conduzido um estudo descritivo e retrospectivo das ações judiciais individuais que pleiteavam medicamentos no estado do Rio Grande do Norte entre 2013 e 2017. Foram coletadas informações nos autos processuais sobre os medicamentos solicitados, os diagnósticos referidos e a origem da prescrição médica, a fim de se analisar as características médico-sanitárias e de gestão da assistência farmacêutica. RESULTADOS: Foram analisados 987 processos, em que foram solicitados 1.517 medicamentos. Desses, 60,7% não faziam parte do elenco da Relação Nacional de Medicamentos Essenciais, e em 75% dos casos havia alternativa terapêutica no Sistema Único de Saúde. Em 13,6% das ações, ao menos um medicamento foi prescrito para uso off label . Os prescritores dos serviços filantrópicos e privados solicitam frequentemente medicamentos não contemplados pela política de assistência farmacêutica. Mesmo os medicamentos judicializados que fazem parte da relação nacional são constantemente solicitados para indicações não padronizadas. CONCLUSÕES: As decisões judiciais para o fornecimento de medicamentos violam regras sanitárias e dificultam a gestão da assistência farmacêutica, o que pode enfraquecer a execução dessas políticas.

Análise das demandas judiciais por medicamentos no Estado do Rio Grande do Norte / Analysis of lawsuits for medicines in the State of Rio Grande do Norte

A judicialização da saúde, especialmente no acesso a medicamentos, é um fenômeno complexo, multifatorial que envolve aspectos técnico-científicos, legais, econômicos e sociais, podendo trazer implicações diversas para a saúde pública. Com o reconhecimento constitucional da saúde como um direito e a implantação do Sistema Único de Saúde (SUS), um número cada vez maior de cidadãos tem buscado o Poder Judiciário para garantir a promessa constitucional, e o número de processos tem crescido ao longo dos anos. Dada sua relevância, o tema da judicialização vêm sendo debatido em diversos espaços: na sociedade, no meio acadêmico, por instituições jurídicas e por gestores da saúde. Entretanto ainda não foi possível traçar um panorama nacional da judicialização de medicamentos no Brasil, havendo uma marcante concentração de pesquisas nas regiões Sudeste e Sul do país. Nesse contexto, o objetivo desse estudo foi identificar e analisar as demandas judicias por medicamentos no Estado do Rio Grande do Norte, buscando descrever as características sociodemográficas, médico-sanitárias e judiciais das ações, fazendo uma análise à luz das políticas de medicamentos vigentes e analisando suas possíveis interfaces com o processo de incorporação de tecnologias no SUS. Para tanto, foi conduzido um estudo descritivo, exploratório e retrospectivo, cuja unidade de análise foram os processos individuais solicitando medicamentos ao Estado do Rio Grande do Norte, entre os anos de 2013 a 2017. Os dados foram obtidos junto a Secretaria Estadual de Saúde Pública (SESAP/RN), e as informações dos processos foram coletadas através de consulta ao sítio eletrônico do Tribunal de Justiça do RN. Foram analisados 987 processos, em que foram solicitados 1517 medicamentos. A maioria dos demandantes foi do sexo feminino (58,8%), residentes no interior do Estado, com idade média de 48,3 anos, representadas predominantemente por assistência jurídica pública (52,8%) e com prescrição oriunda de serviços médicos privados (38,1%). A maioria dos medicamentos pleiteados (61,7%) não estavam incorporados ao SUS, porém, em 75% dos casos, havia alternativa terapêutica. Em 13,6% das ações, ao menos 1 medicamento foi prescrito para uso off-label. Mesmo os medicamentos judicializados que faziam parte da Relação Nacional de Medicamentos Essenciais (Rename), foram constantemente solicitados para indicações não recomendadas nos protocolos oficiais. Em 68% dos casos, houve acesso ao medicamento, sendo o autor responsável pela compra em 56,1% deles, via bloqueio de verbas públicas. O medicamento mais solicitado foi a insulina glargina (74 pedidos). Medicamentos não disponíveis no SUS e frequentemente solicitados nas demandas judiciais tendem a ser incorporados posteriormente, passando a integrar a política de saúde. Dos 10 medicamentos com maior número de ações judiciais, 4 foram posteriormente incorporados ao SUS, com destaque para as insulinas análogas. Em relação ao processo de incorporação desses medicamentos, observou-se que predominaram demandas internas (60%), e a minoria contou com avaliações econômicas (40%), sendo a principal justificativa utilizada no embasamento das decisões, a presença de evidência científica. Porém, foi observada mudança de posicionamento após a expressiva participação em consultas públicas e a judicialização dos medicamentos é mencionada em alguns relatórios. Os resultados mostraram que a via judicial tem se consolidado como forma de acesso a medicamentos no Rio Grande do Norte, inclusive por cidadãos residentes no interior do Estado, que conseguem assistência jurídica gratuita. Foram solicitados principalmente medicamentos ainda não incorporados ao SUS, e essas solicitações frequentemente violaram regras sanitárias e de gestão da Assistência Farmacêutica. O bloqueio de verbas públicas para o cumprimento dessas decisões é outro fator preocupante para o gestor do SUS, pois compromete a execução das políticas de medicamentos programadas, podendo enfraquecer a execução dessas. No processo de incorporação de medicamentos alvo de demandas judiciais, observou-se que apesar da preponderância do embasamento técnico-científico nas decisões de incorporação de medicamentos no SUS, houve influência indireta da judicialização no processo de tomada de decisão (AU).

The judicialization of health, especially in access to medicines, is a complex and multifactorial phenomenon that involves technical-scientific, legal, economic and social aspects, and may have different implications for public health. With the constitutional recognition of health as a right and the implementation of the Unified Health System (Sistema Único de Saúde - SUS), an increasing number of citizens have sought the Judiciary to guarantee the constitutional promise, and the number of lawsuits has grown over the years. As a relevant question, the theme of judicialization has been debated in several spaces: in society, in academia, by legal institutions and by health managers. However, it has not yet been possible to draw a national panorama of the judicialization of medicines in Brazil, with a marked concentration of research in the Southeast and South regions of the country. In this context, the aim of this study was to identify and analyze the lawsuits for medicines in the State of Rio Grande do Norte, describing the sociodemographic, medical-sanitary and judicial characteristics of the processes, making an analysis in the light of current drug policies and evaluating its possible interfaces with the process of incorporating technologies into SUS. It was conducted a descriptive, exploratory and retrospective, whose unit of analysis was the individual processes requesting medicines from the State of Rio Grande do Norte, between the years 2013 to 2017. The data were collected from the State Department of Public Health (SESAP/RN), and the information on the cases was collected through consultation with the website of the Court of Justice of RN. Nine hundred eighty-seven (987) processes were analyzed, in which 1517 medicines were requested. Most of the claimants were female (58.8%), residing in the interior of the State, with an average age of 48.3 years, represented predominantly by public legal assistance (52.8%) and with prescription from private medical services (38.1%). Most of the requested drugs (61.7%) were not incorporated into SUS, however, in 75% of the cases, there was a therapeutic alternative. In 13.6% of the actions, at least 1 medicine was prescribed for off-label use. Even the judicialized drugs that were part of the National List of Essential Medicines (Rename), were constantly requested for indications not recommended in official protocols. In 68% of the cases, access to the drug was available, with the author responsible for the purchase in 56.1% of them, through blocking public funds. The most requested medicine was insulin glargine (74 lawsuits). Drugs not available in SUS and frequently requested in court demands tend to be incorporated later, becoming part of health policy. Of the 10 drugs with the highest number of lawsuits, 4 were subsequently incorporated into SUS, mainly insulin analogues. Regarding the process of incorporating these drugs, it was observed that internal demands predominated (60%), and the minority had economic assessments (40%), the main justification used to support decisions being the presence of scientific evidence. However, a change of position was observed after the expressive participation in public consultations and the judicialization of medicines is mentioned in some reports. The results showed that the judicial system has been consolidated as a way of accessing medicines in Rio Grande do Norte, including by citizens residing in the interior of the State, who obtain free legal assistance. The most of the drugs requested were not yet incorporated into SUS, and these requests frequently violated health and Pharmaceutical Assistance management rules. The blocking of public funds for the fulfillment of these decisions is another worrying factor for the SUS manager, as it compromises the execution of the programmed medicines policies, which impair their execution. In the process of incorporating drugs targeted by lawsuits, it was observed that despite the preponderance of the technical-scientific basis in decisions to incorporate drugs into SUS, there was an indirect influence of judicialization in the decision-making process (AU).

The low-density lipoprotein receptor-related protein 5 (LRP5) 4037C>T polymorphism: candidate for susceptibility to type 1 diabetes mellitus.

OBJECTIVE: The present study has investigated the association between low-density lipoprotein receptor-related protein 5 (LRP5) 4037C>T polymorphism and type 1 diabetes mellitus (T1DM) susceptibility in a Brazilian population. SUBJECTS AND METHODS: A total number of 134 T1DM patients and 180 normoglycemic individuals (NG) aged 6-20 years were studied. Glycated hemoglobin and glucose levels were determined. Genotyping of LRP5 4037C>T (rs3736228) was performed. RESULTS: T1DM patients showed poor glycemic control. Genotypes in the codominant (CT: OR = 2.99 [CI 95%: 1.71-5.24], p < 0.001; TT: OR = 5.34 [CI 95%: 1.05-2702], p < 0.001), dominant (CT + TT: OR = 3.16 [CI 95%: 1.84-5.43], p < 0.001) and log-additive (OR = 2.78 [CI 95%: 1.70-4.52], p < 0.001) models, and LRP5 4037T allele (OR = 2.88, [CI 95%: 1.78-4.77], p < 0.001) were associated with an increased risk of developing T1DM. LRP5 4037CT and CT+TT carriers in T1DM group showed higher concentrations of serum glucose and glycated hemoglobin when compared with CC carriers. CONCLUSION: The LRP5 4037C>T may represent a candidate for T1DM susceptibility, as well as poor glycemic control.

The low-density lipoprotein receptor-related protein 5 (LRP5) 4037C>T polymorphism: candidate for susceptibility to type 1 diabetes mellitus

ABSTRACT Objective: The present study has investigated the association between low-density lipoprotein receptor-related protein 5 (LRP5) 4037C>T polymorphism and type 1 diabetes mellitus (T1DM) susceptibility in a Brazilian population. Subjects and methods: A total number of 134 T1DM patients and 180 normoglycemic individuals (NG) aged 6-20 years were studied. Glycated hemoglobin and glucose levels were determined. Genotyping of LRP5 4037C>T (rs3736228) was performed. Results: T1DM patients showed poor glycemic control. Genotypes in the codominant (CT: OR = 2.99 [CI 95%: 1.71-5.24], p < 0.001; TT: OR = 5.34 [CI 95%: 1.05-2702], p < 0.001), dominant (CT + TT: OR = 3.16 [CI 95%: 1.84-5.43], p < 0.001) and log-additive (OR = 2.78 [CI 95%: 1.70-4.52], p < 0.001) models, and LRP5 4037T allele (OR = 2.88, [CI 95%: 1.78-4.77], p < 0.001) were associated with an increased risk of developing T1DM. LRP5 4037CT and CT+TT carriers in T1DM group showed higher concentrations of serum glucose and glycated hemoglobin when compared with CC carriers. Conclusion: The LRP5 4037C>T may represent a candidate for T1DM susceptibility, as well as poor glycemic control.

Prevalence and risk factors of inadequate medicine home storage: a community-based study.

OBJECTIVE: Assess the extent of inadequate home storage of medicines andidentify important risk factors. METHODS: A cross-sectional survey based on a probability sample in the community, conducted in 267 households in Cuité, State of Paraíba, Northeast Brazil, in 2014. Logistic regression was used to study the risk factors. RESULTS: The prevalence of households with inadequate storage was 76.0%. Problems with storage include direct exposure to sunlight in 10.9% of households, the presence of dust in 23.6%, and storage within reach of children in 76.0%. Medications no longer used are usually disposed of into the environment in 92.1% of households. Inadequate storage is more likely when home organization of medications is the responsibility of a male subject (OR = 1.729) or an older person (OR = 1.029), when out of date medicines are found (OR = 2.963), and in households with no children (OR = 2.088). CONCLUSIONS: Physicians and pharmacists should advise patients on how to adequately store medicines at home, especially when the person in charge of medications is a male or an older adult, and if there are no children in the household.

Relationship between glycemic control and OPG gene polymorphisms with lower bone mineral density in patients with type 1 Diabetes mellitus

ABSTRACT The aim of the present study was to investigate the bone mineral density (BMD) of patients with type 1 Diabetes mellitus (T1DM). We also assessed the association between osteoprotegerin (OPG) genetic polymorphisms and BMD. Genotyping was performed for 1181G>C and 163A>G OPG polymorphisms by allelic discrimination in 119 patients with T1DM and 161 normoglycemic (NG) individuals, aged 6 to 20 years old. Glycemic control, serum parameters of bone metabolism and BMD were evaluated. T1DM patients showed low BMD, poor glycemic control and decreased total calcium values when compared to controls (p < 0.05). For all the polymorphisms studied, the genotype and allele frequencies in patients with T1DM were not significantly different from the controls. In patients with T1DM, carriers of OPG 1181CC showed higher concentrations of ionized calcium compared to patients with GG+GC genotypes. These results suggest that low BMD is associated with poor glycemic control in T1DM. Despite the lack of a detected association between OPG polymorphisms and BMD in these patients, the increased ionized calcium in those carrying OPG 1181CC suggests a possible increase in osteoclastogenesis, a conclusion that may be supported by the lower BMD observed in these subjects.

Prevalence and risk factors of inadequate medicine home storage: a community-based study

ABSTRACT OBJECTIVE Assess the extent of inadequate home storage of medicines andidentify important risk factors. METHODS A cross-sectional survey based on a probability sample in the community, conducted in 267 households in Cuité, State of Paraíba, Northeast Brazil, in 2014. Logistic regression was used to study the risk factors. RESULTS The prevalence of households with inadequate storage was 76.0%. Problems with storage include direct exposure to sunlight in 10.9% of households, the presence of dust in 23.6%, and storage within reach of children in 76.0%. Medications no longer used are usually disposed of into the environment in 92.1% of households. Inadequate storage is more likely when home organization of medications is the responsibility of a male subject (OR = 1.729) or an older person (OR = 1.029), when out of date medicines are found (OR = 2.963), and in households with no children (OR = 2.088). CONCLUSIONS Physicians and pharmacists should advise patients on how to adequately store medicines at home, especially when the person in charge of medications is a male or an older adult, and if there are no children in the household.

Association of polymorphisms in IL6 gene promoter region with type 1 diabetes and increased albumin-to-creatinine ratio.

BACKGROUND: Pro-inflammatory cytokines, such as interleukin-6 (IL-6), have been considered as key factors in type 1 diabetes mellitus (T1DM) and diabetic nephropathy, thus, our aim was to investigate the association of IL6-174G>C (rs1800795) and -634C>G (rs1800796) polymorphisms with T1DM susceptibility and diabetic nephropathy. METHODS: These polymorphisms were analyzed in 144 children and adolescents with T1DM and 173 normoglycemic control subjects. Glycemic control, laboratory parameters of kidney function and serum lipids were evaluated. By studying only T1DM patients, we evaluated the polymorphisms associated with relevant biochemical parameters in various genetic models. RESULTS: Type 1 diabetes mellitus patients showed poor glycemic control and albumin-to-creatinine ratio, total cholesterol and LDL-cholesterol levels increased when compared with normoglycemic subjects (p < 0.001, p = 0.004 and p < 0.001, respectively). IL6-174C allele was associated with an increased risk of developing T1DM (OR = 1.53, CI = 1.01-2.31, p = 0.044). In the T1DM group, IL6-174CC carriers showed higher concentrations of glycated hemoglobin (p = 0.029), albumin-to-creatinine ratio (p = 0.021), total cholesterol (p = 0.010), and LDL-cholesterol (p = 0.002), when compared with GG+GC carriers. No association was found for the IL6-634C>G polymorphism. CONCLUSIONS: These results suggest that IL6-174G>C may contribute to T1DM and increased albumin-to-creatinine ratio as well as to poor glycemic control and hyperlipidemia.

Oophorectomy hinders antioxidant adaptation promoted by swimming in Wistar rats.

Oxidative stress is associated with postmenopause and is also responsible for various metabolic alterations. The redox imbalance observed during ovarian decline can be induced experimentally by bilateral ovariectomy in rats. In addition to hormone replacement, regular moderate physical exercise is indicated to prevent several common postmenopausal diseases. This study aimed to assess the effect of daily swimming on the antioxidant defense system of oophorectomized Wistar rats. Control and oophorectomized groups were submitted to 1 h of daily swimming for 90 days. Levels of lipid peroxidation and glutathione content and the activities of superoxide dismutase enzyme and glutathione peroxidase in erythrocytes, liver, and brain were assessed every 30 days. The control group exhibited lower lipoperoxidation that was associated with a significant increase in superoxide dismutase enzyme activity, glutathione peroxidase activity, and glutathione content in erythrocytes and liver; however, swimming did not cause changes in antioxidant parameters in the brain over time. The oophorectomized group showed no antioxidant adaptation to daily swimming and had greater oxidative damage in the liver and blood. Our results suggest that ovariectomy hinders antioxidant adaptation in Wistar rats submitted to daily swimming.

Prevalência e caracterização dos casos de mielomeningocele no Rio Grande do Norte / Prevalence of myelomeningocele and patient characteristics in Rio Grande do Norte State, Brazil

Objetivo: Identificar o coeficiente de prevalência e caracterizar os casos de crianças com mielomeningocele. Métodos:Foi realizado um levantamento dos casos ocorridos de ielomeningocele no Hospital Infantil Varela Santiago, Rio Grande do Norte, nos anos 2004 e 2005. Foi aplicado um questionário com as variáveis: sexo da criança, má-formação congênita associada, escolaridade da mãe, renda familiar, tipo de água, tipo de farinha, assistência social, diagnóstico pré-natal de mielomeningocele e história familiar da doença. Resultados: O coeficiente de prevalência em 2004 foi de 6:10.000 nascidos-vivos, enquanto, em 2005, foi de 2:10.000 nascidos-vivos. Um percentual de 59,1% dos pacientes foi do sexo masculino, sendo a má-formação associada à mielomeningocele a hidrocefalia, em 82,6% dos casos. Em 56,5% das famílias entrevistadas, a renda mensal era menor ou igual a um salário-mínimo. A água consumida em 91,0% das famílias era encanada. A farinha de mandioca caseira foi consumida em 50,0%. Apenas 4,3% das crianças apresentavam assistência social. Quanto à escolaridade, 47,8% das mães tinham ensino fundamental incompleto (menos de quatro anos de estudo). Todas as mães realizaram pré-natal, sendo que 40,9% iniciaram apenas no segundo trimestre de gestação. Em somente 22,7% das crianças foi dado o diagnóstico pré-natal de mielomeningocele por meio do exame ultrassonográfico. Em relação ao histórico familiar, 13,6% dos pais relataram mielomeningocele na família. Finalmente, quanto à utilização de suplementos, 13,6% não fizeram suplementação de vitaminas, e apenas 21,1% fizeram uso do ácido fólico. Conclusão: O estudo chama a atenção para o fato de que parte das mães iniciou o pré-natal no segundo trimestre de gestação, com o agravante de que a doença, na maior parte das vezes, não foi diagnosticada no exame ultrassonográfico. O estudo aponta a necessidade de ações educativas na área de saúde da mulher, com melhoria na qualidade dos serviços de diagnóstico

This study aimed to identify the prevalence of children with myelomeningocele and describe their characteristics. Methods: A questionnaire was used for collecting the following data from children with myelomeningocele who visited the Hospital Infantil Varela Santiago in Rio Grande do Norte between 2004 and 2005: sex, associated congenital malformation, mother’s education level, household income, home’s water source, Social Assistance, prenatal diagnosis of myelomeningocele and family history of the disease. Results: Myelomeningocele prevalences in 2004 and 2005 were 6:10,000 and 2:10,000 live births, respectively. Most (82.6%) patients also had hydrocephalus, 59.1% were male, 22.7% had been diagnosed before birth by ultrasound, 13.6% had a family history of myelomeningocele, 4.3% had Social Assistance, 56.5% had a household income equal to or below one minimum wage, 91.0% of the households had piped water, 50.0% of the households consumed homemade cassava flour, 47.8% of the children’s mothers had less than 4 years of formal education, all mothers had attended prenatal care, 40.9% of the mothers started prenatal care on the second trimester of pregnancy, and 13.6% of the mothers did not take vitamin supplements during pregnancy. Conclusion:The study draws attention to the fact that some mothers only began prenatal care on the second trimester of pregnancy, and worse, the disease was often not detected by ultrasound. The study shows that education actions on woman’s health and better quality diagnostic services are necessary.