Augusto Afonso Guerra

Judicialização do acesso a medicamentos no Estado de Minas Gerais, Brasil

OBJETIVO: Analisar o perfil dos requerentes e dos medicamentos pleiteados em acoes judiciais. METODOS: Estudo descritivo sobre 827 processos judiciais com 1.777 pedidos de medicamentos de 2005 a 2006 no Estado de Minas Gerais. Avaliaram-se os tipos de atendimento no sistema de saude e a representacao dos autores junto ao Poder Judiciario. Os medicamentos foram descritos segundo registro na Agencia Nacional de Vigilância Sanitaria, essencialidade, inclusao programatica no Sistema Unico de Saude e evidencias de eficacia. RESULTADOS: Mais de 70% dos autores foram atendidos no sistema privado de saude e 60,3% foram representados por advogados particulares. O diagnostico mais frequente foi o de artrite reumatoide (23,1%) e os imunossupressores foram os medicamentos mais solicitados (principalmente adalimumabe e etanercepte). Aproximadamente 5% dos medicamentos pleiteados nao eram registrados na Agencia, 19,6% estavam presentes na Relacao Nacional de Medicamentos Essenciais, 24,3% compunham o Programa de Medicamentos de Alto Custo e 53,9% apresentavam evidencia consistente de eficacia. Dentre os medicamentos nao disponiveis no sistema publico, 79,0% apresentavam alternativa terapeutica nos programas de assistencia farmaceutica. CONCLUSOES: O fenomeno da judicializacao na saude pode indicar falhas do sistema publico de saude, uma vez que ha solicitacoes de medicamentos constantes de suas listas. Todavia, constitui um obstaculo para a pratica do uso racional de medicamentos e para a consolidacao das premissas da Politica Nacional de Medicamentos, principalmente quando sao solicitados medicamentos sem comprovacao de eficacia e nao padronizados pelo Sistema Unico de Saude.OBJECTIVE To analyze the profile of claimants and medicines demanded in lawsuits. METHODS Descriptive study that examined 827 lawsuits with 1,777 demands of access to medicines in the period between July 2005 and June 2006 in the state of Minas Gerais, Southeastern Brazil. There were examined the type of health care provided to claimants and their attorneyship. The medicines were described based on the following: drug registration at the National Health Surveillance Agency (Anvisa); wheter they were essential medicines; supply in the Brazilian Health System programs; and evidence of drug efficacy. RESULTS More than 70% of the claimants were provided care in the private health system and 60.3% hired private lawyers. The most common diagnosis of claimants was rheumatoid arthritis (23.1%) and the immunosuppressant agents were the most frequent demand medicines (mainly adalimumab and etanercept). Approximately 5% of the medicines demanded were not registered at Anvisa, 19.6% were included in the Brazilian List of Essential Medicine, 24.3% were included in the High-Cost Drug Program and 53.9% showed consistent evidence of efficacy. Among the medicines that were not available in Brazilian Health System, 79.0% had therapeutic alternatives in drug programs. CONCLUSIONS The phenomenon of judicialization of health in Brazil can point out failures in the public health system as some medicines demanded are included in its lists. However, it is a barrier for rational drug use and application of the National Drug Policy guidelines, especially when there are demanded medicines with no evidence of efficacy and that are not included in Brazilian Health System standards.

Treatment of postmenopausal osteoporosis in women: a systematic review

Osteoporosis, a typical disease of the elderly, has become a frequent and relevant public health problem. Several drugs are available for treatment of osteoporosis, some of which are currently dispensed by the Brazilian Unified National Health System. The objective of this study was to present a systematic review of drugs for treatment of osteoporosis, focusing on the adequacy of clinical protocols based on existing evidence in the scientific literature. We conducted a search for randomized clinical trials in PubMed and LILACS that presented results for bone mineral density, incidence of vertebral fractures, and adverse effects. 32 articles met the reviews inclusion criteria. Bisphosphonates were reported to have consistently reduced the risk of vertebral fractures. Hormone replacement therapy showed positive outcomes, but its use has been found to increase the risk of cardiovascular disease and breast cancer. Teriparatide and monofluorophosphate also showed efficacy against osteoporosis. Calcium and vitamin D were given to patients as food supplements.

Cyclosporine Versus Tacrolimus in Immunosuppressive Maintenance Regimens in Renal Transplants in Brazil: Survival Analysis from 2000 to 2004

BACKGROUND In Brazil, the National Health System (SUS) is responsible for almost all renal transplants. SUS protocols recommend using cyclosporine, in association with azathioprine and corticosteroids, to maintain the immunosuppression that is essential for successful renal transplant. Alternatively, cyclosporine can be replaced by tacrolimus. OBJECTIVE To evaluate the effectiveness of therapeutic schema involving cyclosporine or tacrolimus after renal transplant during a 60-month follow-up period. METHODS A historical cohort study, from 2000 to 2004, was conducted using 5686 patients who underwent renal transplant and received cyclosporine or tacrolimus. Uni - and multivariate analyses were performed using the Cox model to examine factors associated with progression to treatment failure. RESULTS Most of the patients were male, aged 38 years or older, for whom the most frequent primary diagnosis of chronic renal failure (CRF) was glomerulonephritis/nephritis. Higher risk of treatment failure was associated with: therapeutic regimen (tacrolimus, HR 1.38, 95% CI 1.14 to 1.67), patient age at transplantation (additional year, HR 1.01, 95% CI 1.00 to 1.02), donor type (deceased, HR 1.60, 95% CI 1.35 to 1.89), median time of dialysis prior to transplantation (>24 mo, HR 1.29, 95% CI 1.09 to 1.52), and primary CRF diagnosis (diabetes, HR 1.54, 95% CI 1.09 to 2.17). CONCLUSIONS The risk of treatment failure of patients receiving tacrolimus was observed to be 1.38 times that of those receiving cyclosporine, after adjusting the model for possible confounding factors such as patient sex, patient age, graft origin, prior time of dialysis, and cause of CRF. Our results were obtained from an observational study, and further studies are necessary to evaluate whether compliance with SUS clinical protocols could result in more effective care for renal transplant recipients.

Implementation of clinical guidelines in Brazil: should academic detailing be used?

The Brazilian National Health System provides high cost medicines through the Specialized Component of Pharmaceutical Assistance in accordance with the adherence to agreed Clinical Guidelines. However, physician compliance to these Guidelines, as well as the barriers and facilitators related to them and the influence on the subsequent quality of care provided is unknown. Consequently, the objectives of this article are to undertake a review of international experiences and scientific publications of a strategy to disseminate and communicate guidelines to physicians through Academic Detailing. Subsequently, use the findings to develop and conduct a pilot Academic Detailing Programme in Brazil targeting specialists who prescribe medicines for patients with Alzheimers disease, which are part of the Specialized Component of Pharmaceutical Assistance.

Efficacy of interferon (conventional, pegylated) and lamivudine for treatment of chronic hepatitis B: a systematic review

Chronic hepatitis B is considered a major public health problem, and its treatment entails increasing health budget expenses with high-cost drugs covered by Unified National Health System. The objective of this study was to compare the efficacy of interferon (conventional; pegylated - PEG2a) and lamivudine (LAM) for the treatment of chronic hepatitis B through a systematic review, selecting randomized, controlled clinical trials identified in PubMed and LILACS. Target outcomes were virological, biochemical, and histological response, seroconversion, and adverse effects. The review selected 35 articles. Presence or absence of HBeAg and pre-treatment alanine aminotransferase (ALT) levels were considered important factors in the initial therapeutic indication. Treatment with conventional interferon enables lasting disease inactivation and can result in HBsAg seroconversion. PEG2a showed better efficacy than interferon and LAM and similar side effects to interferon. LAM presents advantages such as its sensitivity in the HbeAg-negative phenotype, while its main disadvantage is the development of resistance.A hepatite cronica B constitui um grave problema de saude publica e vem demonstrando crescentes gastos com financiamento de medicamentos de dispensacao em carater excepcional e de alto custo no Sistema Unico de Saude (SUS). O objetivo do estudo foi comparar a eficacia do interferon (convencional; peguilado - PEG2a) e lamivudina (LAM) para o tratamento da hepatite cronica B, pelo metodo de revisao sistematica selecionando ensaios clinicos randomizados e controlados identificados nas bases PubMed e LILACS. As medidas de resultado consideradas foram resposta virologica, soroconversao, resposta bioquimica, resposta histologica e efeitos adversos. Foram selecionados 35 artigos. A presenca ou ausencia do HBeAg e os niveis de alanina amino transferase (ALT) no pre-tratamento demonstraram papel fundamental na indicacao terapeutica inicial. O tratamento com interferons convencionais permite a inativacao da doenca por longos periodos de tempo, podendo resultar em soroconversao HBsAg. O PEG 2a demonstrou eficacia superior ao interferon e LAM e efeitos colaterais semelhantes ao interferon. A LAM apresenta vantagem de ser sensivel para os pacientes HBeAg negativo e apresenta como maior desvantagem o desenvolvimento de resistencia.

Medication Persistence of Disease‐Modifying Antirheumatic Drugs and Anti–Tumor Necrosis Factor Agents in a Cohort of Patients With Rheumatoid Arthritis in Brazil

To assess the use and persistence of anti–tumor necrosis factor (anti‐TNF) versus disease‐modifying antirheumatic drug (DMARD) therapies in patients with rheumatoid arthritis (RA) in Brazil.

Pesquisa Nacional sobre Acesso, Utilização e Promoção do Uso Racional de Medicamentos: métodos

RESUMO A Pesquisa Nacional sobre Acesso, Utilizacao e Promocao do Uso Racional de Medicamentos (PNAUM) – componente Servicos teve por objetivo caracterizar a organizacao dos servicos de assistencia farmaceutica na Atencao Basica do Sistema Unico Saude. A PNAUM – Servicos foi um estudo transversal, avaliativo, com amostra planejada de 600 municipios, realizado entre 2014 e […]ABSTRACT The Pesquisa Nacional sobre Acesso, Utilização e Promoção do Uso Racional de Medicamentos –Serviços (PNAUM – National Survey on Access, Use and Promotion of Rational Use of Medicines – Services) aimed to characterize the organization of pharmaceutical services in the Primary Health Care of the Brazilian Unified Health System (SUS). PNAUM – Services is a cross-sectional and evaluative study, with planned sample of 600 cities, held between 2014 and 2015, composed of a remote phase, with telephone interviews with health managers. Of these 600 cities, 300 were selected for a survey on health services. We selected the 27 capitals, the 0.5% largest cities of each region, and the remaining cities were drawn. The estimate of the representative national sample size considered three levels: cities, medicine dispensing services, and patients. The interviews were carried out with a structured questionnaire specific for: municipal secretaries of health, professionals responsible for pharmaceutical services in the city, professionals responsible for the dispensing of medicines, physicians, and patients. The secondary data were obtained in official databases, in the latest update date. PNAUM – Services was the first nationwide research aimed at the assessment and acquisition of national and regional indicators on access to medicines, as well as use and rational use, from the perspective of various social subjects.

Concepções de assistência farmacêutica na atenção primária à saúde, Brasil

OBJETIVO Identificar e discutir as concepcoes de assistencia farmaceutica segundo distintos atores, na Atencao Primaria a Saude, no Brasil. METODOS Estudo integrante da Pesquisa Nacional sobre Acesso, Utilizacao e Promocao do Uso Racional de Medicamentos – Servicos, 2015, composta por levantamento de informacoes numa amostra representativa de municipios, estratificada pelas regioes do Brasil, e sub-amostra […]ABSTRACT OBJECTIVE To identify and discuss the conceptions of pharmaceutical services in Brazilian Primary Health Care, according to different subjects. METHODS This study is part of the Pesquisa Nacional sobre Acesso, Utilização e Promoção do Uso Racional de Medicamentos – Serviços, 2015 (PNAUM – National Survey on Access, Use and Promotion of Rational Use of Medicines – Services, 2015), which is composed of an information survey in a representative sample of cities, stratified according to Brazilian regions, and a subsample of primary health care services. Municipal secretaries of health, those responsible for pharmaceutical services, and those responsible for medicine delivery in pharmacies/dispensing units of the selected services were interviewed. The questionnaires included one question about the understanding of the interviewee regarding pharmaceutical services. The content analysis technique was used to apprehend, in the statements, the meanings attributed to pharmaceutical services, which were subsequently classified into categories according to their main conceptions. RESULTS Among the wide diversity of conceptions on pharmaceutical services (PS), we highlight the ones focused on 1) logistic control of medicines with activities concerning guidance or information on their use and 2) guidance or information to users on the use of medicine. The findings reveal a shifting tendency from a medicine-focused conception to one that considers the users and their needs as the final recipient of these actions. However, the lack of references to conceptions regarding care management and integrality point out the slowness of this change; after all, this is a social and historical process that comprises the production of meanings that transcend legal, logistic, and technical arrangements in pharmaceutical services. CONCLUSIONS The diversity of conceptions expresses the several meanings attributed to pharmaceutical services; we also identified, in their reorientation process, a movement that reflects a gradual shift in the technical paradigm, from the focus on medicine logistics to a user-oriented approach of health services.

Assistência farmacêutica na atenção primária: a pactuação interfederativa no desenvolvimento das políticas farmacêuticas no Sistema Único de Saúde (SUS)

I Núcleo de Estudos de Políticas Públicas. Universidade Estadual de Campinas. Campinas, SP, Brasil II Programa de Pós-Graduação em Saúde Coletiva. Departamento de Saúde Coletiva. Faculdade de Ciências Médicas. Universidade Estadual de Campinas. Campinas, SP, Brasil III Programa de Pós-Graduação em Epidemiologia. Faculdade de Medicina. Universidade Federal do Rio Grande do Sul. Porto Alegre, RS, Brasil IV Departamento de Farmácia. Faculdade de Ciências da Saúde. Universidade de Brasília. Brasília, DF, Brasil V Prefeitura Municipal de Florianópolis. Florianópolis, SC, Brasil VI Programa de Pós-Graduação em Epidemiologia. Faculdade de Medicina. Universidade Federal do Rio Grande do Sul. Porto Alegre, RS, Brasil VII Departamento de Farmácia Social. Faculdade de Farmácia. Universidade Federal de Minas Gerais. Belo Horizonte, MG, Brasil VIII Faculdade de Ciências Farmacêuticas. Pontifícia Universidade Católica de Campinas. Campinas, SP, Brasil

Avanços e desafios da assistência farmacêutica na atenção primária no Sistema Único de Saúde

I Núcleo de Estudos de Políticas Públicas. Universidade Estadual de Campinas. Campinas, SP, Brasil II Programa de Pós-Graduação em Saúde Coletiva. Departamento de Saúde Coletiva. Faculdade de Ciências Médicas. Universidade Estadual de Campinas. Campinas, SP, Brasil III Programa de Pós-Graduação em Epidemiologia. Faculdade de Medicina. Universidade Federal do Rio Grande do Sul. Porto Alegre, RS, Brasil IV Departamento de Farmácia. Faculdade de Ciências da Saúde. Universidade de Brasília. Brasília, DF, Brasil V Prefeitura Municipal de Florianópolis. Florianópolis, SC, Brasil VI Programa de Pós-Graduação em Epidemiologia. Faculdade de Medicina. Universidade Federal do Rio Grande do Sul. Porto Alegre, RS, Brasil VII Departamento de Farmácia Social. Faculdade de Farmácia. Universidade Federal de Minas Gerais. Belo Horizonte, MG, Brasil VIII Faculdade de Ciências Farmacêuticas. Pontifícia Universidade Católica de Campinas. Campinas, SP, Brasil