Daniel Resende Faleiros

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.OBJECTIVEnTo analyze the profile of claimants and medicines demanded in lawsuits.nnnMETHODSnDescriptive 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.nnnRESULTSnMore 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.nnnCONCLUSIONSnThe 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.

Pesquisa e produção científica em economia da saúde no Brasil

This article presents a diagnosis of the health economics (HE) in Brazil, based on a survey of HE research groups currently registered in the National Council for Scientific and Technological Development (CNPq), as well as an inventory of the Brazilian scientific production in HE, published between January 1999 and June 2004, available in the Bireme Virtual Health Library (Paho/WHO). It describes the data considering geographic regions, types of institution and topics of research. Of the research groups with works related to HE subject matters, 48 have very diversified activities, concentrated in the Southeastern region of the country. Only 14% (376) of the 2.617 publications that had been evaluated were related to HE. Most of the studies were published in 2002 and their main topics were management, financing, allocative efficiency and equity in the distribution of health resources. The diagnosis allows the identification of important aspects that help understand the development of the HE field in Brazil between 1999 and 2004.

Perfil demográfico e epidemiológico dos usuários de medicamentos de alto custo no Sistema Único de Saúde

The Program for High-Cost Medicines of the Brazilian Health Ministry was set up to respond to the demand for high unit-cost medication or for medication used for chronic diseases that imply a high overall cost for treatment. To describe the epidemiological and demographic profiles of patients enrolled in the program, a probabilistic-deterministic connection was made between data in sections of the Health Ministrys databases (DATASUS), namely, the Outpatient Information System (APAC/SIA) and the Mortality Information System (SIM). The cohort formed by linking databases identified 611,419 individuals who began treatment between 2000 and 2004. The analyses were disaggregated by sex, region of residence, diagnoses and most widely used drugs.The construction of this historical cohort made possible a description of the epidemiological characteristics and drugs used by the programs users. The database generated can also provide analyses for specific diseases, with results that can contribute to evaluations of effectiveness and efficiency of clinical protocols, in order to better inform decision-makers regarding the planning and supplying of high-cost medication by the Brazilian Health Ministry.The Program for High-Cost Medicines of the Brazilian Health Ministry was set up to respond to the demand for high unit-cost medication or for medication used for chronic diseases that imply a high overall cost for treatment. To describe the epidemiological and demographic profiles of patients enrolled in the program, a probabilistic-deterministic connection was made between data in sections of the Health Ministry’s databases (DATASUS), namely, the Outpatient Information System (APAC/SIA) and the Mortality Information System (SIM). The cohort formed by linking databases identified 611,419 individuals who began treatment between 2000 and 2004. The analyses were disaggregated by sex, region of residence, diagnoses and most widely used drugs.The construction of this historical cohort made possible a description of the epidemiological characteristics and drugs used by the program’s users. The database generated can also provide analyses for specific diseases, with results that can contribute to evaluations of effectiveness and efficiency of clinical protocols, in order to better inform decision-makers regarding the planning and supplying of high-cost medication by the Brazilian Health Ministry.

Budget impact analysis of medicines: updated systematic review and implications

ABSTRACT This evaluation determines whether published studies to date meet the key characteristics identified for budget impact analyses (BIA) for medicines, accomplished through a systematic review and assessment against identified key characteristics. Studies from 2001–2015 on ‘budget impact analysis’ with ‘drug’ interventions were assessed, selected based on their titles/abstracts and full texts, and their characteristics checked according to key criteria. Out of 1,984 studies, 92 were subsequently identified for review. Of these, 95% were published in Europe and the USA. 2012 saw the largest number of publications (16%) with a decline thereafter. 48% met up to 7 out of the 9 key characteristics. Only 22% stated no conflict of interest. The results indicate low adherence to the key characteristics that should be considered for BIAs and strong conflict of interest. This is an issue since BIAs can be of fundamental importance in managing the entry of new medicines including reimbursement decisions.

Financing of Pharmaceutical Services in the municipal management of the Brazilian Unified Health System

ABSTRACT OBJECTIVE To discuss factors related to the financing of the Basic Component of Pharmaceutical Services within the municipal management of the Brazilian Unified Health System. METHODS The Pesquisa Nacional sobre Acesso, Utilização e Promoção do Uso Racional de Medicamentos no Brasil – Serviços (PNAUM – National Survey on Access, Use and Promotion of Rational Use of Medicines – Services) is a cross-sectional, exploratory, and evaluative study that performed an information survey in a representative sample, stratified by Brazilian regions It considered different study populations in the sampling plan, which represent primary health care services in the cities. Data were collected in 2015 by two methods: in person, by applying direct observation scripts and interviews with users, physicians, and professionals responsible for the dispensing of medicines in primary care services; by telephone interviews with municipal health managers and municipal professionals responsible for Pharmaceutical Services. The results were extracted from the questionnaires applied by telephone. RESULTS Of the sample of 600 eligible cities, we collected 369 interviews (61.5%) with secretaries and 507 (84.5%) with pharmaceutical services managers. 70.8% of the cities have a computerized management system; and 11.9% have qualification/training of professionals. More than half (51.3%) of the cities received funds for the structuring of pharmaceutical services, and almost 60% of these cities performed this type of spending. In 35.4% of cases, municipal secretaries of health said that they use resources of medicines from the Componente Básico da Assistência Farmacêutica (CBAF – Basic Component of Pharmaceutical Services) to cover demands of other medicines, but only 9.7% believed that these funds were sufficient to cover the demands. The existence of a permanent bidding committee exclusively for acquiring medicines was reported in 40.0% of the cities. CONCLUSIONS We found serious deficiencies in the public financing of medicines, as well as little concern about the formality in the use of public resources, expenses that meet individual demands to the detriment of the community, insufficient resources allocated to the Basic Component of Pharmaceutical Services, and exhaustion of the financing model.

Judicialización del acceso a medicamentos en el Estado de Minas Gerais, Sureste de 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.OBJECTIVEnTo analyze the profile of claimants and medicines demanded in lawsuits.nnnMETHODSnDescriptive 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.nnnRESULTSnMore 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.nnnCONCLUSIONSnThe 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.

Perfil demográfico y epidemiológico de los usuarios de medicamentos de costo elevado en el Sistema Único de Salud

The Program for High-Cost Medicines of the Brazilian Health Ministry was set up to respond to the demand for high unit-cost medication or for medication used for chronic diseases that imply a high overall cost for treatment. To describe the epidemiological and demographic profiles of patients enrolled in the program, a probabilistic-deterministic connection was made between data in sections of the Health Ministrys databases (DATASUS), namely, the Outpatient Information System (APAC/SIA) and the Mortality Information System (SIM). The cohort formed by linking databases identified 611,419 individuals who began treatment between 2000 and 2004. The analyses were disaggregated by sex, region of residence, diagnoses and most widely used drugs.The construction of this historical cohort made possible a description of the epidemiological characteristics and drugs used by the programs users. The database generated can also provide analyses for specific diseases, with results that can contribute to evaluations of effectiveness and efficiency of clinical protocols, in order to better inform decision-makers regarding the planning and supplying of high-cost medication by the Brazilian Health Ministry.The Program for High-Cost Medicines of the Brazilian Health Ministry was set up to respond to the demand for high unit-cost medication or for medication used for chronic diseases that imply a high overall cost for treatment. To describe the epidemiological and demographic profiles of patients enrolled in the program, a probabilistic-deterministic connection was made between data in sections of the Health Ministry’s databases (DATASUS), namely, the Outpatient Information System (APAC/SIA) and the Mortality Information System (SIM). The cohort formed by linking databases identified 611,419 individuals who began treatment between 2000 and 2004. The analyses were disaggregated by sex, region of residence, diagnoses and most widely used drugs.The construction of this historical cohort made possible a description of the epidemiological characteristics and drugs used by the program’s users. The database generated can also provide analyses for specific diseases, with results that can contribute to evaluations of effectiveness and efficiency of clinical protocols, in order to better inform decision-makers regarding the planning and supplying of high-cost medication by the Brazilian Health Ministry.

Epidemiological profile of high cost medicines users in the Brazilian Health System

The Program for High-Cost Medicines of the Brazilian Health Ministry was set up to respond to the demand for high unit-cost medication or for medication used for chronic diseases that imply a high overall cost for treatment. To describe the epidemiological and demographic profiles of patients enrolled in the program, a probabilistic-deterministic connection was made between data in sections of the Health Ministrys databases (DATASUS), namely, the Outpatient Information System (APAC/SIA) and the Mortality Information System (SIM). The cohort formed by linking databases identified 611,419 individuals who began treatment between 2000 and 2004. The analyses were disaggregated by sex, region of residence, diagnoses and most widely used drugs.The construction of this historical cohort made possible a description of the epidemiological characteristics and drugs used by the programs users. The database generated can also provide analyses for specific diseases, with results that can contribute to evaluations of effectiveness and efficiency of clinical protocols, in order to better inform decision-makers regarding the planning and supplying of high-cost medication by the Brazilian Health Ministry.The Program for High-Cost Medicines of the Brazilian Health Ministry was set up to respond to the demand for high unit-cost medication or for medication used for chronic diseases that imply a high overall cost for treatment. To describe the epidemiological and demographic profiles of patients enrolled in the program, a probabilistic-deterministic connection was made between data in sections of the Health Ministry’s databases (DATASUS), namely, the Outpatient Information System (APAC/SIA) and the Mortality Information System (SIM). The cohort formed by linking databases identified 611,419 individuals who began treatment between 2000 and 2004. The analyses were disaggregated by sex, region of residence, diagnoses and most widely used drugs.The construction of this historical cohort made possible a description of the epidemiological characteristics and drugs used by the program’s users. The database generated can also provide analyses for specific diseases, with results that can contribute to evaluations of effectiveness and efficiency of clinical protocols, in order to better inform decision-makers regarding the planning and supplying of high-cost medication by the Brazilian Health Ministry.