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1.
Cad Saude Publica ; 35(8): e00099619, 2019 Aug 29.
Artigo em Português | MEDLINE | ID: mdl-31483045

RESUMO

In April 2019, a ruling was signed for the incorporation of the drug nusinersen by the Brazilian Unified National Health System (SUS). Nusinersen is the most expensive drug ever incorporated by the SUS and is used to treat type I 5q spinal muscular atrophy. The incorporation has been described as a milestone in decision-making on new technologies in the SUS, enabled through a risk-sharing agreement. The article discusses the process involved in the incorporation of nusinersen, highlighting the context, timing, and technical issues, in addition to possible consequences for the institutionalization of health technology assessment (HTA) in the SUS. The study used an exploratory method, reviewing public information produced by the Commission for Incorporation of Technologies in the SUS (CONITEC) and searches in government databanks on prices and purchases. A timeline was produced, describing the key points in the process of incorporation. There were two formal requests for the drug's incorporation. The first was submitted by the Division of Science, Technology, and Strategic Inputs (SCTIE) of the Brazilian Ministry of Health and was turned down unanimously in November 2018. This was followed by a petition by the head of the SCTIE to the Attorney General's Office (AGU) to overrule the recommendation by the CONITEC plenary. The AGU recommended a new submission, made by the drug's manufacturing company, which was approved unanimously in March 2019. The was no addition of new evidence or a price reduction to justify the change of decision. No elements were identified in the risk-sharing agreement. This suggests problems of transparency and accountability, as well as risks in the process of institutionalization of HTA that had been underway in the SUS.

2.
Ciênc. Saúde Colet ; 24(3): 1153-1164, mar. 2019. tab, graf
Artigo em Inglês | LILACS-Express | ID: biblio-989582

RESUMO

Abstract This study maps and analyzes patient flows for breast cancer chemotherapy in order to identify the potential implications for organization of pharmaceutical services in the cancer care network. An ecological study design sought to correlate the place of residence with place of care for breast cancer patients. All chemotherapy procedures financed by Brazil's Unified Health System (SUS) and performed from January to December 2013 were included. Flows were mapped using TerraView® software. A total of 1 347 803 outpatient chemotherapy procedures were delivered by 243 cancer care units located in 156 municipalities. Seventeen cities concentrated approximately 50.0 % of the procedures. A total of 8 538 origin-destination flows were generated and 49.2% of procedures were performed in services located outside the municipality in which the patient resided. Context challenges, related to inequality of access to chemotherapy and hindrances in planning and management of pharmaceutical services, were discussed.


Resumo Este estudo mapeia e analisa os fluxos percorridos por pacientes em uso de quimioterapia para o tratamento do câncer de mama no Brasil, usando metodologia de redes, de forma a identificar potenciais implicações para a organização da assistência farmacêutica na rede de atenção oncológica. Realizou-se um estudo ecológico correlacionando o local de residência com o de atendimento de pacientes com câncer de mama. Incluiu-se todos os procedimentos de quimioterapia financiados pelo Sistema Único de Saúde (SUS), realizados no ano de 2013. O mapeamento dos fluxos foi efetuado no programa TerraView®. Foram realizados 1.347.803 procedimentos ambulatoriais de quimioterapia em 243 unidades habilitadas pelo SUS, sediadas em 156 municípios brasileiros. Dezessete cidades concentraram aproximadamente 50,0% dos atendimentos. Foram gerados 8.538 fluxos de origem-destino e 49,2% dos procedimentos foram realizados em serviços sediados fora do município de residência da mulher. Alguns aspectos da organização da assistência farmacêutica, relacionados a desigualdades no acesso à quimioterapia e dificuldades no planejamento de ações e serviços farmacêuticos foram problematizados frente ao contexto apresentado.

3.
Cien Saude Colet ; 24(3): 1153-1164, 2019 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-30892535

RESUMO

This study maps and analyzes patient flows for breast cancer chemotherapy in order to identify the potential implications for organization of pharmaceutical services in the cancer care network. An ecological study design sought to correlate the place of residence with place of care for breast cancer patients. All chemotherapy procedures financed by Brazil's Unified Health System (SUS) and performed from January to December 2013 were included. Flows were mapped using TerraView® software. A total of 1 347 803 outpatient chemotherapy procedures were delivered by 243 cancer care units located in 156 municipalities. Seventeen cities concentrated approximately 50.0 % of the procedures. A total of 8 538 origin-destination flows were generated and 49.2% of procedures were performed in services located outside the municipality in which the patient resided. Context challenges, related to inequality of access to chemotherapy and hindrances in planning and management of pharmaceutical services, were discussed.


Assuntos
Antineoplásicos/administração & dosagem , Neoplasias da Mama/tratamento farmacológico , Acesso aos Serviços de Saúde , Assistência Farmacêutica/estatística & dados numéricos , Brasil , Feminino , Disparidades em Assistência à Saúde/estatística & dados numéricos , Humanos , Programas Nacionais de Saúde/estatística & dados numéricos , Características de Residência/estatística & dados numéricos
4.
Interface (Botucatu, Online) ; 23: e180297, 2019. tab
Artigo em Português | LILACS | ID: biblio-1002339

RESUMO

Este artigo, fundamentado na Teoria da Estruturação de Giddens, buscou analisar a organização e as práticas da assistência farmacêutica em oncologia em cinco municípios brasileiros por meio de um estudo de casos múltiplos, tendo o câncer de mama como condição marcadora. A subunidade de análise foram as unidades habilitadas de atenção oncológica. Foram entrevistados dez gestores e quinze profissionais de saúde. Complementarmente, foram considerados documentos e dados da observação direta da ação dos profissionais. Os resultados foram analisados segundo quatro eixos: estrutura organizacional, financiamento, tecnologias e processos de trabalho. Destacaram-se: a baixa articulação das ações de assistência farmacêutica realizadas entre os níveis de atenção à saúde, problemas estruturais nos serviços, insuficiência de financiamento, atrasos nos processos de avaliação e incorporação de tecnologias, e falhas nos processos de trabalho. Os aspectos destacados contribuem para a precariedade do funcionamento do sistema.


Este artículo, fundamentado en la Teoría de la Estructuración de Giddens, buscó analizar la organización y las prácticas de la asistencia farmacéutica en oncología en cinco municipios brasileños, por medio de un estudio de casos múltiples, teniendo el cáncer de mama como condición marcadora. La subunidad de análisis fueron las unidades habilitadas de atención oncológica. Se entrevistaron diez gestores y quince profesionales de salud. Complementariamente, se consideraron documentos y datos de observación directa de la acción de los profesionales. Los resultados se analizaron de acuerdo con cuatro ejes: estructura organizacional, financiación, tecnologías y procesos de trabajo. Se destacó la baja articulación de las acciones de asistencia farmacéutica realizadas entre los niveles de atención de la salud, problemas estructurales en los servicios, insuficiencia de financiación, atrasos en los procesos de evaluación e incorporación de tecnologías y fallas en los procesos de trabajo. Los aspectos destacados contribuyen para la precariedad del funcionamiento del sistema.


This study, based on the Giddens' Structuration Theory, aimed to analyze organization and pharmaceutical services practices for oncology care in five brazilian municipalities by a multiple-case study design, having breast cancer as a marker condition. Oncology care-certified facilities were established as analysis sub-units. In-depth interviews were conducted with ten managers and fifteen health professionals. Research strategy also involved document analysis and direct observation of practices. Results were analyzed according to four main themes: organizational structure, financing, technologies and work process. We found little interaction of pharmaceutical services with levels of care, structural problems within facilities, insufficient funding, belated technology assessment and technology adoption, and shortfalls in work processes. These aspects contribute to precarious functioning of the cancer-care system.


Assuntos
Humanos , Masculino , Feminino , Assistência Farmacêutica/organização & administração , Sistema Único de Saúde/organização & administração , Assistência à Saúde/organização & administração , Oncologia
5.
Cien Saude Colet ; 23(6): 1937-1949, 2018 Jun.
Artigo em Português, Inglês | MEDLINE | ID: mdl-29972501

RESUMO

This article examines pharmaceutical services and access to essential medicines in Brazil during the 30 years since the advent of Brazil's Unified Health System from a comprehensiveness perspective. The following topics are addressed: the "realignment" of pharmaceutical services; human resources in pharmaceutical services; the essential medicines concept; the rational use of medicines; technological advances and drug manufacturing; and ethical regulation. With a strong regulatory focus and a structural framework centered on the National Medicines Policy, the past three decades represent a mixture of progress and setbacks, considering the national complexities of the healthcare system and the political, economic and social changes that have influenced policy and access to medicines, which is a key concern even in the world's richest countries, as the forums of discussion on global health have demonstrated. We show that major steps forward have been taken, highlighting that the recent fiscal austerity measures imposed by the government threaten to seriously undermine social progress.


Assuntos
Indústria Farmacêutica/tendências , Acesso aos Serviços de Saúde/tendências , Programas Nacionais de Saúde/organização & administração , Assistência Farmacêutica/organização & administração , Brasil , Assistência Integral à Saúde/organização & administração , Assistência Integral à Saúde/tendências , Assistência à Saúde/organização & administração , Assistência à Saúde/tendências , Medicamentos Essenciais/provisão & distribução , Saúde Global , Política de Saúde , Humanos , Programas Nacionais de Saúde/tendências , Assistência Farmacêutica/tendências , Política
6.
Expert Rev Pharmacoecon Outcomes Res ; 18(5): 565-572, 2018 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-29869896

RESUMO

BACKGROUND: Immunosuppressants are recommended for treatment of autoimmune diseases, and in transplant therapy. The high cost of these drugs has been causing an important impact on global pharmaceutical spending. OBJECTIVE: Analyzing immunosuppressant expenditure in Brazil, using data from the Federal Procurement System database (SIASG), between 2010 and 2015. METHODS: The pharmaceutical products were classified in accordance with the Anatomical, Therapeutic and Chemical (ATC) classification system recommended by World Health Organization (WHO) and aggregated by volume and by expenditure. The expenditure variation was decomposed into three broad categories: price effects, quantity effects, and drug mix effects. RESULTS: During the period, annual expenditure increased by 49%, ranging from USD 494.5 million in 2010 to USD 738.7 million in 2015, while purchased quantities increased by 294%, ranging from 49.8 million in 2010 to 196.5 million in 2015. Two factors drove expenditures: the quantity effect and the drug-mix effect. CONCLUSION: These findings may contribute to understand immunosuppressant spending trends and the factors that influence them in order to formulate effective cost containment strategies and design optimum drug policy. Rigorous evaluations are recommended to reduce the drug-mix effect, including systems to monitor price, effectiveness, safety, therapeutic value and budget impact of pharmaceutical innovations.


Assuntos
Custos de Medicamentos/tendências , Gastos em Saúde/tendências , Imunossupressores/administração & dosagem , Doenças Autoimunes/tratamento farmacológico , Doenças Autoimunes/economia , Brasil , Controle de Custos , Humanos , Imunossupressores/economia , Transplante de Órgãos/economia , Transplante de Órgãos/métodos
7.
Ciênc. Saúde Colet ; 23(6): 1937-1949, jun. 2018. tab
Artigo em Português | LILACS-Express | ID: biblio-952651

RESUMO

Resumo Os autores analisam a Assistência Farmacêutica (AF) e o acesso a medicamentos no Brasil na perspectiva do princípio da integralidade nos 30 anos do SUS. A partir da sua inclusão no movimento de reforma sanitária, foram selecionados temas relevantes, incluindo a reorientação da AF, a questão de recursos humanos, o conceito de medicamentos essenciais, o uso apropriado de medicamentos, o desenvolvimento tecnológico e a produção industrial e a regulação ética. Com fortes componentes regulatórios e tendo a política nacional de medicamentos como eixo estruturante, as três décadas do SUS são confrontadas entre avanços e retrocessos, considerando a complexidade nacional, as mudanças políticas, econômicas e sociais que impactaram políticas públicas e o acesso a medicamentos, tema que hoje mostra sua importância mesmo nas economias mais ricas do mundo, a partir de foros de discussão relacionados com Saúde Global. As conquistas ao longo do tempo são destacadas, considerando a preocupação decorrente do regime fiscal que compromete as áreas sociais.


Abstract This article examines pharmaceutical services and access to essential medicines in Brazil during the 30 years since the advent of Brazil's Unified Health System from a comprehensiveness perspective. The following topics are addressed: the "realignment" of pharmaceutical services; human resources in pharmaceutical services; the essential medicines concept; the rational use of medicines; technological advances and drug manufacturing; and ethical regulation. With a strong regulatory focus and a structural framework centered on the National Medicines Policy, the past three decades represent a mixture of progress and setbacks, considering the national complexities of the healthcare system and the political, economic and social changes that have influenced policy and access to medicines, which is a key concern even in the world's richest countries, as the forums of discussion on global health have demonstrated. We show that major steps forward have been taken, highlighting that the recent fiscal austerity measures imposed by the government threaten to seriously undermine social progress.

8.
Physis (Rio J.) ; 28(1): e280106, 2018. tab
Artigo em Português | LILACS | ID: biblio-895649

RESUMO

Resumo O Programa Farmácia Popular do Brasil (PFPB) tem como uma de suas características a interface que promove entre o setor público e o privado. A partir de 2011, passou a integrar o rol de ações do Plano Brasil Sem Miséria (BSM), com a iniciativa "Saúde Não Tem Preço" (SNTP), caracterizada pela gratuidade da provisão de medicamentos para hipertensão, diabetes e asma. O estudo teve como objetivo verificar o papel do SNTP nos municípios-alvo do BSM em Mato Grosso do Sul. Foi realizado inquérito baseado em método da OMS em 40 farmácias credenciadas de 15 municípios. Foram coletadas informações sobre o perfil socioeconômico e demográfico dos usuários, condições de saúde e medicamentos, além das etapas percorridas para obtenção dos mesmos. Entre os 896 usuários entrevistados, havia grande proporção de mulheres, acima de 60 anos, com baixa escolaridade e renda entre meio e dois salários mínimos. Aproximadamente, 95% vinham do SUS e mais de 60% relatou tentar obter os medicamentos no posto de saúde, mas a indisponibilidade os levou às farmácias credenciadas. Mais de 55% dos usuários chegaram ao SNTP por recomendação dos profissionais do SUS. Estima-se que, nesses municípios, a população mais pobre não chegou ao SNTP.


Abstract The Brazilian Popular Pharmacy Program promotes an interface between the public and private sectors. From 2011, the Program took part in the actions contemplated by the Brazil Without Poverty (BSM) Plan, through the "Saúde Não Tem Preço" (SNTP) initiative, characterized by free Ministry of Health-financed provision of medicines for hypertension, diabetes and asthma, dispensed in private Program-certified facilities. The study aimed to assess the role played by SNTP in BSM target municipalities in Mato Grosso do Sul state. A survey in 40 pharmacies from 15 municipalities, based on a WHO methodology, collected socioeconomic and demographic profile of users, as well as health perceptions, medicines and steps taken to obtain them. Among the 896 interviewees, there was a greater proportion of females, over 60 years, with low schooling, and total income between half and two minimum wages. About 95% of users came to the SNTP from public health system. More than 60% reported trying to obtain the medicines at public facilities, but unavailability led them to certified pharmacies. More than 55% of users were directed to SNTP by recommendation of a SUS health professional. We estimate that in these target municipalities the poorest segment of the population did not access SNTP.


Assuntos
Humanos , Síndrome de Imunodeficiência Adquirida , Antirretrovirais , Brasil , HIV , Patente , Ativismo Político , Tenofovir
9.
Epidemiol Serv Saude ; 26(4): 771-782, 2017 Oct-Dec.
Artigo em Inglês, Português | MEDLINE | ID: mdl-29211141

RESUMO

OBJECTIVE: to describe hospitalizations due to drug poisonings in children under five years old, in Brazil, from 2003 to 2012. METHODS: descriptive study, with data from the National Hospital Information System (SIH/SUS); the drugs involved were divided into therapeutic classes, according to the Anatomical Therapeutic Chemical Classification (ATC). RESULTS: 17,725 hospitalizations were identified, from which 22,395 poisonings were identified, and 75 deaths; the most common therapeutic classes were unspecified drugs (38.0%), antiepileptic/sedative-hypnotics/anti-parkinson drugs (19.8%), systemic antibiotics (13.4%) and non-opioid-analgesics/antipyretics (6.5%), varying among country regions and age groups; in 38.5% of the poisonings it was not possible to correlate therapeutic classes and ATC categories. CONCLUSION: the high frequency of unspecified drugs was a limitation; among the specified drugs, the most common were those that act in the central nervous system and those used in pediatric diseases (antibiotics and analgesics).

10.
Epidemiol. serv. saúde ; 26(4): 771-782, out.-dez. 2017. tab, graf
Artigo em Português | LILACS | ID: biblio-953351

RESUMO

OBJETIVO: descrever as internações hospitalares devidas às intoxicações medicamentosas em menores de cinco anos de idade no Brasil, de 2003 a 2012. MÉTODOS: estudo descritivo, com dados do Sistema de Informações Hospitalares do Sistema Único de Saúde (SIH/SUS); os medicamentos envolvidos foram categorizados em classes terapêuticas, conforme a classificação Anatomical Therapeutic Chemical (ATC). RESULTADOS: foram identificadas 17.725 internações, com diagnóstico de 22.395 intoxicações e 75 óbitos; as classes terapêuticas mais frequentes nas intoxicações foram fármacos não especificados (38,0%), antiepilépticos/sedativo-hipnóticos/antiparkinsonianos (19,8%), antibióticos sistêmicos (13,4%) e analgésicos/antitérmicos não opiáceos (6,5%), variando conforme região do país e idade das crianças; em 38,5% das intoxicações, não foi possível correlacionar classes terapêuticas e categorias ATC. CONCLUSÃO: a elevada frequência de fármacos não especificados foi uma limitação; entre as intoxicações com fármacos especificados, predominaram medicamentos que atuam no sistema nervoso central e aqueles utilizados em doenças comuns à infância (antibióticos e analgésicos).


OBJETIVO: describir las internaciones hospitalarias por intoxicaciones medicamentosas en menores de cinco años en Brasil entre 2003 y 2012. MÉTODOS: estudio descriptivo, con datos del Sistema de Información Hospitalaria del Sistema Único de Salud (SIH/SUS); los medicamentos involucrados se clasificaron en clases terapéuticas según clasificación Anatomical Therapeutic Chemical. RESULTADOS: fueron identificadas 17.725 hospitalizaciones, con diagnóstico de 22.395 intoxicaciones y 75 óbitos; las clases terapéuticas más implicadas fueron fármacos no especificados (38,0%), antiepilépticos/hipnóticos sedantes/antiparkinsonianos (19,8%), antibióticos sistémicos (13,4%) y analgésicos/antipiréticos no opiáceos (6,5%), variando según región del país y edad de los niños; en 38,5% de las intoxicaciones no fue posible correlacionar clases terapéuticas ni categorías ATC. CONCLUSIÓN: la elevada frecuencia de fármacos no especificados fue una limitación; entre las intoxicaciones con fármacos especificados, predominaron diagnósticos medicamentos con acción sobre sistema nervoso central y los utilizados en enfermedades comunes en la infancia (antibióticos y analgésicos).


OBJECTIVE: to describe hospitalizations due to drug poisonings in children under five years old, in Brazil, from 2003 to 2012. METHODS: descriptive study, with data from the National Hospital Information System (SIH/SUS); the drugs involved were divided into therapeutic classes, according to the Anatomical Therapeutic Chemical Classification (ATC). RESULTS: 17,725 hospitalizations were identified, from which 22,395 poisonings were identified, and 75 deaths; the most common therapeutic classes were unspecified drugs (38.0%), antiepileptic/sedative-hypnotics/anti-parkinson drugs (19.8%), systemic antibiotics (13.4%) and non-opioid-analgesics/antipyretics (6.5%), varying among country regions and age groups; in 38.5% of the poisonings it was not possible to correlate therapeutic classes and ATC categories. CONCLUSION: the high frequency of unspecified drugs was a limitation; among the specified drugs, the most common were those that act in the central nervous system and those used in pediatric diseases (antibiotics and analgesics).


Assuntos
Humanos , Masculino , Feminino , Pré-Escolar , Envenenamento , Preparações Farmacêuticas , Hospitalização/estatística & dados numéricos , Lactente , Epidemiologia Descritiva
12.
Physis (Rio J.) ; 27(3): 749-769, Jul.-Set. 2017. tab, graf
Artigo em Português | LILACS | ID: biblio-895610

RESUMO

Resumo O consumo do metilfenidato vem atingindo níveis elevados no Brasil. Além do aumento significativo do diagnóstico de TDAH, transtorno cujo tratamento é realizado com metilfenidato, há indícios que este incremento se deu pela automedicação. Sabe-se que informações da internet, mais especificamente do Facebook, exercem forte influência em padrões de uso, apontando importantes desdobramentos do processo de farmaceuticalização da sociedade. Os objetivos deste artigo são introduzir a metodologia de pesquisa digital, mais especificamente, a aplicação de softwares de extração de dados de redes sociais (Facebook), e por meio dela mapear as informações sobre o uso deste medicamento nessas redes. O conteúdo, de acesso público, foi analisado e categorizado mediante ancoragem da literatura sobre o tema da farmaceuticalização. O mapeamento permitiu observar que o Facebook oferece importantes espaços virtuais para a circulação de informações, com um alcance de aproximadamente 600.000 pessoas. Os espaços representam fóruns de discussões onde as principais controvérsias sobre os usos do metilfenidato são colocadas: diagnóstico, identidade TDAH, resistência ao uso do medicamento, aquisição. Considerando os principais pontos suscitados por este mapeamento, é possível afirmar que, no caso do consumo do metilfenidato, seu uso apresenta aspectos da farmaceuticalização da vida cotidiana.


Abstract In the last five years, Brazil has presented a significant increase in ADHD diagnosis. Methylphenidate is the drug of choice for treatment and consumption has reached high levels. There is evidence that this increase is due to self-medication. It is known that information from the internet, specifically from Facebook, exerts a strong influence on use patterns, reflecting important developments in the process of pharmaceuticalization. The objectives of this article are to map information on the use of this medicine in virtual networks, by first introducing the digital research methodology, specifically the application of social networking data extraction software (Facebook). The publicly accessed content was analyzed and categorized using anchoring about pharmaceuticalization, provided by the literature. Facebook provides an important virtual environment for the circulation of information on methylphenidate consumption, with a range of about 600,000 people. The virtual discussion forums address the main controversies about methylphenidate use, which are diagnosis, ADHD identity, resistance to the use of the drug and acquisition. This form of information dissemination permits the identification and characterization of non-therapeutic uses of methylphenidate.


Assuntos
Humanos , Transtorno do Deficit de Atenção com Hiperatividade , Automedicação/tendências , Internet , Uso de Medicamentos/tendências , Mídias Sociais , Medicalização , Metilfenidato
14.
Cien Saude Colet ; 22(8): 2581-2594, 2017 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-28793074

RESUMO

The provision of ARVs is central to HIV/AIDS programs, because of its impact on the course of the disease and on quality of life. Although first-line treatments costs have declined, treatment-associated expenses are steeper each year. Sustainability is therefore an important variable for the success of treatment programs. A conceptual framework on sustainability of ARV provision was developed, followed by data collection instruments. The pilot study was undertaken in Brazil. Bolivia, Peru and Mozambique, were visited. Key informants were identified and interviewed. Investigation of sustainability related to ARV provision involved implementation and routinization events of provision schemes. Evidence of greater sustainability potential was observed in Peru, where provision is implemented and routinized by the National HIV/AIDS program and expenditures met by the government. In Mozambique, provision is dependent on donations and external aid, but the country displays a great effort to incorporate ARV provision and care in routine healthcare activities. Bolivia, in addition to external dependence on financing and management of drug supply, presents problems regarding implementation and routinization. The conceptual framework was useful in recognizing events that influence sustainable ARV provision in these countries.


Assuntos
Síndrome de Imunodeficiência Adquirida/tratamento farmacológico , Fármacos Anti-HIV/provisão & distribução , Infecções por HIV/tratamento farmacológico , Qualidade de Vida , Bolívia , Brasil , Assistência à Saúde/organização & administração , Países em Desenvolvimento , Humanos , Peru , Projetos Piloto , Desenvolvimento de Programas , Avaliação de Programas e Projetos de Saúde
15.
Ciênc. Saúde Colet ; 22(8): 2527-2538, Ago. 2017. tab, graf
Artigo em Português | LILACS-Express | ID: biblio-890406

RESUMO

Resumo O artigo analisa as compras de medicamentos para hepatite C, feitas pelo Ministério da Saúde (MS), de 2005 a 2015. Os dados são do Sistema Integrado de Administração de Serviços Gerais (SIASG). Para estimar o gasto contratado anual selecionou-se medicamentos previstos nos Protocolos Clínicos e Diretrizes Terapêuticas para Hepatite C do MS e incluiu-se todas as apresentações e concentrações que apareceram no SIASG. Houve aumento de 159,5 vezes no gasto com os medicamentos selecionados de 2005 a 2006 porque esses produtos passaram a ser comprados de forma centralizada. Em 2007 houve aumento de 730% no gasto pela incorporação de alfapeginterferona 2a e 2b. Em 2012 a compra de dois novos antivirais de ação direta (AAD) representou 99% do gasto anual. Em 2015, a adoção de novos AAD provocou aumento de 230% (R$ 945 milhões) no gasto do MS. No período estudado houve aumento dos gastos do MS com os medicamentos para Hepatite C devido ao aumento do volume adquirido e à incorporação tecnológica de alfapeginterferona e de novos AAD. Garantir acesso universal ao tratamento da hepatite C depende da implementação de estratégias que aumentem o poder de barganha do MS em negociações de redução de preços de produtos em situação de monopólio.


Abstract This paper analyzes the Minister of Health's (MoH) procurement of medicines for hepatitis C from 2005 to 2015. Data sources were the Integrated General Services Administration (SIASG), to estimate annual expenditure for selected medicines of the MoH Clinical Protocols and Therapeutic Guidelines (PCDT) for Hepatitis C. All presentations and strengths recorded on SIASG were included. The unit prices were estimated based on the purchase with the highest volume each year. There was a 159.5 fold increase in expenditure of the selected medicines from 2005 to 2006, because procurement of those medicines became centralized. In 2007 there was 730% increase in spending due to the incorporation of pegainterferons alfa 2a and 2b. In 2012 the purchase of only two new direct-acting antivirals (DAA) accounted for 99% of total annual expenditure. In 2015 the adoption of a new DAA led to an increase of 230% (R$945 million) in MoH spending. The significant increase of MoH expenditure on medicines for hepatitis C from 2005 to 2015 was due to the increase of volumes purchased as well as the incorporation of alfapeginterferon and new DAAs. Ensuring universal access to treatment for hepatitis C will depend on the implementation of strategies that strengthen the MoH's bargaining power in price reduction negotiations with the manufacturers of monopoly medicines.

16.
Ciênc. Saúde Colet ; 22(8): 2581-2594, Ago. 2017. tab
Artigo em Inglês | LILACS-Express | ID: biblio-890416

RESUMO

Abstract The provision of ARVs is central to HIV/AIDS programs, because of its impact on the course of the disease and on quality of life. Although first-line treatments costs have declined, treatment-associated expenses are steeper each year. Sustainability is therefore an important variable for the success of treatment programs. A conceptual framework on sustainability of ARV provision was developed, followed by data collection instruments. The pilot study was undertaken in Brazil. Bolivia, Peru and Mozambique, were visited. Key informants were identified and interviewed. Investigation of sustainability related to ARV provision involved implementation and routinization events of provision schemes. Evidence of greater sustainability potential was observed in Peru, where provision is implemented and routinized by the National HIV/AIDS program and expenditures met by the government. In Mozambique, provision is dependent on donations and external aid, but the country displays a great effort to incorporate ARV provision and care in routine healthcare activities. Bolivia, in addition to external dependence on financing and management of drug supply, presents problems regarding implementation and routinization. The conceptual framework was useful in recognizing events that influence sustainable ARV provision in these countries.


Resumo A provisão de medicamentos ARV é central para programas de HIV/Aids, devido a seu impacto no curso da doença e na qualidade de vida. Embora os custos de tratamentos de primeira linha tenham diminuído, os gastos dos programas com os tratamentos tem aumentado a cada ano. A sustentabilidade torna-se fator fundamental para o sucesso dos programas. Um modelo conceitual para avaliação da sustentabilidade da provisão de ARV e instrumentos de coleta de dados foram desenvolvidos. Um estudo piloto foi realizado no Brasil e a pesquisa de campo cobriu Bolívia, Moçambique e Peru. Informantes-chaves foram identificados e entrevistados. Eventos críticos de implementação e rotinização foram investigados na história dos programas. Foi observado maior potencial para sustentabilidade no Peru, onde a provisão está implementada e rotinizada e os gastos são cobertos pelo governo nacional. Em Moçambique, o financiamento da provisão é quase totalmente dependente de ajuda internacional, mas há grandes esforços voltados à expansão da cobertura e rotinização do cuidado a PVH. Na Bolívia, além da dependência externa para o financiamento há problemas de implementação e gerenciamento da provisão. O modelo avaliativo mostrou-se útil na identificação de fatores que influenciam a capacidade para sustentabilidade dos programas nesses países.

18.
Int J Technol Assess Health Care ; 33(2): 279-287, 2017 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-28641588

RESUMO

OBJECTIVES: Health technology financing is often based on randomized controlled trials (RCTs), which are often the same ones used for licensing. Because they are designed to show the best possible results, typically Phase III studies are conducted under ideal and highly controlled conditions. Consequently, it is not surprising that technologies do not always perform in real life in the same way as controlled conditions. Because financing (and price paid) decisions can be made with overestimated results, health authorities need to ask whether health systems achieve the results they expect when they choose to pay for a technology. The optimal way to answer this question is to assess the performance of financed technologies in real-world settings. Health technology performance assessment (HTpA) refers to the systematic evaluation of the properties, effects, and/or impact of a health intervention or health technology in the real world to provide information for investment/disinvestment decisions and clinical guideline updates. The objective is to describe the development and principal aspects of the Guideline for HTpA commissioned by the Brazilian Ministry of Health. METHODS: Our methods used include extensive literature review, refinement with experts across countries, and public consultation. RESULTS: A comprehensive guideline was developed, which has been adopted by the Brazilian government. CONCLUSION: We believe the guideline, with its particular focus on disinvestment, along with the creation of a specific program for HTpA, will allow the institutionalization and continuous improvement of the scientific methods to use real-world evidence to optimize available resources not only in Brazil but across countries.


Assuntos
Tecnologia Biomédica , Avaliação da Tecnologia Biomédica , Brasil , Guias como Assunto , Humanos , Ensaios Clínicos Controlados Aleatórios como Assunto
19.
Cad Saude Publica ; 33(5): e00010616, 2017 Jun 12.
Artigo em Inglês | MEDLINE | ID: mdl-28614444

RESUMO

Planning for mass gatherings involves health system preparedness based on an understanding of natural and technological hazards identified through prior risk assessment. We present the expected hazards reported by health administrators of the host cities for the 2014 FIFA World Cup in Brazil and discuss the hazards considering minimal available public hospital beds in the 12 cities at the time of the event. Four different groups of respondents were interviewed: pharmaceutical service administrators and overall health administrators at both the municipal and hospital levels. The hospital bed occupancy rate was calculated, based on the Brazilian Health Informatics Department (DATASUS). The number of surplus beds was calculated using parameters from the literature regarding surge and mass casualty needs and number of unoccupied beds. In all groups, physical injuries ranked first, followed by emerging and endemic diseases. Baseline occupancy rates were high (95%CI: 0.93-2.19) in all 12 cities. Total shortage, considering all the cities, ranged from -47,670 (for surges) to -60,569 beds (for mass casualties). The study can contribute to discussions on mass-gathering preparedness.


Assuntos
Aniversários e Eventos Especiais , Número de Leitos em Hospital/estatística & dados numéricos , Futebol , Brasil , Cidades , Planejamento em Desastres , Serviço Hospitalar de Emergência , Humanos , Entrevistas como Assunto , Incidentes com Feridos em Massa , Admissão do Paciente , População Urbana
20.
Basic Clin Pharmacol Toxicol ; 121(3): 181-188, 2017 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-28371342

RESUMO

The aim was to analyse the implementation dynamics of the essential medicines list (EML). We used the government expenditures on medicines and Brazil as a case study. Drug purchases were considered as a proxy for utilization. The essential medicines (EMs) expenditures were followed over time by Brazilian National EMLs life-time and defined by broad therapeutic categories and by specific medicines. Brazil increased the number of the medicines during the last four editions of Brazilian National EMLs and the federal government expenditures on them. The EML implementation dynamics changed the distribution of expenditures on EMs. We identified a common set of 404 EMs present in all four editions of the Brazilian National EMLs. There was a proportional decrease in expenditures on anti-infectives for systemic use, blood and blood-forming organs and alimentary tract and metabolism, and increase in expenditures on antineoplastic and immunomodulating agents. The expenditures distribution per specific medicines revealed that a small set of EMs was responsible for 50% or more of expenditures considering Brazilian National EML life-time for all four periods. The increase in expenditures on EMs in Brazil was a consequence of the newer medicines incorporated over time in the Brazilian National EMLs. The use of the medicines expenditures as a source of data and the definition of an EML life-time permitted follow-up of the implementation dynamics of different versions of the Brazilian National EMLs. Our results have implications for policymakers and stakeholders to gain a better understanding of the role EMLs play in health system sustainability and in the provision of the most beneficial heath care.


Assuntos
Custos de Medicamentos , Uso de Medicamentos , Medicamentos Essenciais/uso terapêutico , Formulários Farmacêuticos como Assunto , Brasil , Bases de Dados Factuais , Custos de Medicamentos/tendências , Uso de Medicamentos/tendências , Medicamentos Essenciais/economia , Governo Federal , Gastos em Saúde , Implementação de Plano de Saúde , Humanos , Estudos de Casos Organizacionais
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