Hypertension and diabetes treatment affordability and government expenditures following changes in patient cost sharing in the "Farmácia popular" program in Brazil: an interrupted time series study.

BACKGROUND: Increasing medicines availability and affordability is a key goal of Brazilian health policies. "Farmácia Popular" (FP) Program is one of the government's key strategies to achieve this goal. Under FP, antihypertension (HTN) and antiglycemic (DM) medicines have been provided at subsidized prices in private retail settings since 2006, and free of charge since 2011. We aim to assess the impact of sequential changes in FP benefits on patient affordability and government expenditures for HTN and DM treatment under the FP, and examine their implications for public financing mechanisms and program sustainability. METHODS: Longitudinal, retrospective study using interrupted time series to analyze: HTN and DM treatment coverage; total and per capita expenditure; percentage paid by MoH; and patient cost sharing. Analyzes were conducted in the dispensing database of the FP program (from 2006 to 2012). RESULTS: FP has increased its coverage over time; by December 2012 FP covered on average 13% of DM and 11.5% of HTN utilization, a growth of over 600 and 1500%, respectively. The overall cost per treatment to the MoH declined from R$36.43 (R$ = reais, the Brazilian currency) to 18.74 for HTN and from R$33.07to R$15.05 for DM over the period analyzed, representing a reduction in per capita cost greater than 50%. The amount paid by patients for the medicines covered increased over time until 2011, but then declined to zero. We estimate that to treat all patients in need for HTN and DM in 2012 under FP, the Government would need to expend 97% of the total medicines budget. CONCLUSIONS: FP rapidly increased its coverage in terms of both program reach and proportion of cost subsidized during the period analyzed. Costs of individual HTN and DM treatments in FP were reduced after 2011 for both patients (free) and government (better negotiated prices). However, overall FP expenditures by MoH increased due to markedly increased utilization. The FP is sustainable as a complementary policy but cannot feasibly substitute for the distribution of medicines by the SUS.

Expenditure of biological drugs for rheumatoid arthritis treatment in the Brazilian public health system.

OBJECTIVE: This work aims to analyze the quantity and expenses related to biological drugs used for the treatment of rheumatoid arthritis (RA) in outpatient public care within the Brazilian Unified Health System (SUS). METHODS: It is a cross-sectional descriptive study based on secondary data from a historical series, referring to the purchase, volume, and the number of patients treated with different biological drugs (infliximabe, etanercept, adalimumab, rituximab, abatacept, tocilizumab, golimumab, and certolizumab pegol) for RA treatment in outpatient care from 2012 to 2017. The data were extracted from the SUS Outpatient Information System database-SIA/SUS and included ten drugs used for RA treatment. The study assessed the quantity and expenditure of these drugs, the number of RA patients treated, and the expenditure by RA subtypes. The National Broad Consumer Price Index was used to adjust the expenditures for December 2017. RESULTS: The Ministry of Health allocated approximately $500 million to provide about 2 million units of biological drugs for RA patients from 2012 to 2017. The supply of adalimumab 40 mg and etanercept 50 mg accounted for 68.3% of the total expenditure. The subtypes "other rheumatoid arthritis with rheumatoid factor" (ICD-10 M05.8), "rheumatoid arthritis without rheumatoid factor" (ICD-10 M06.0), and "Felty's syndrome" (M05. 0) represented 84.5% of the total expenditures. The proportion of patients treated with biological drugs increased by 33.0%. There was a significant 83.0% increase in the number of patients using biological drugs compared to the overall number of RA patients treated during the study period. CONCLUSIONS: The results obtained allow us to draw a more recent profile of expenditure on RA treatment and indicate trends in the use of biological drugs for this condition, generating data that can support management decisions in public health policies.

Reversal of the recommendations issued by the National Commission for the Incorporation of Technologies in SUS after Public Consultations. / Reversão das recomendações emitidas pela Comissão Nacional de Incorporação de Tecnologias no SUS após Consultas Públicas.

The work analyzed the effect of Public Consultations (PC) and their contributions to the recommendations of the National Commission for the Incorporation of Technologies (CONITEC). This is a descriptive and retrospective study with a qualitative-quantitative approach using a secondary data source of public access, between 2012 and 2017. A database was developed to characterize the PC of medications and their contributions, which allowed the identification of cases of reversals between the preliminary and final recommendation of CONITEC. We analyzed the contributions in cases of reversal for characterization of argumentative axes and type of basis. Of the 307 demands for incorporation of medications, 205 went through PC, with 23,894 contributions. The reversal of the recommendations occurred in 9% of the open PC (15 medications), all in the sense of non-incorporation for incorporation. Main argumentative axes dealt with clinical benefits and minor adverse events, with prevalence of the submission of clinical experiences and opinions. Advances in the processes of incorporation of technologies in the SUS by performing PC were found and the challenge that decision makers face in institutional spaces for the improvement of social participation to strengthen the public benefit was clear.

O trabalho analisou o efeito das Consultas Públicas (CP) e suas contribuições nas recomendações da Comissão Nacional de Incorporação de Tecnologias (CONITEC). Trata-se de estudo descritivo e retrospectivo, com abordagem qualiquantitativa, com fonte de dados secundárias de acesso público, entre 2012 e 2017. Elaborou-se banco de dados para caracterizar as CP de medicamentos e suas contribuições, o que permitiu identificar casos de reversões entre a recomendação preliminar e final da CONITEC. Analisou-se as contribuições nos casos de reversão para caracterização de eixos argumentativos e tipo de embasamento. Das 307 demandas de incorporação, 205 destes passaram por CP, com 23.894 contribuições. A reversão das recomendações ocorreu em 9% das CP abertas (15 medicamentos), todas no sentido da não incorporação para incorporação. Principais eixos argumentativos trataram de benefícios clínicos e menores eventos adversos, prevalecendo o envio de experiências clínicas e opiniões. Evidencia-se avanços nos processos de incorporação de tecnologias no SUS pela realização da CP e ficou claro o desafio que os tomadores de decisão enfrentam nos espaços institucionais para o aprimoramento da participação social no sentido de fortalecer o benefício público.

[From community pharmacies to big pharmacy chains: private provision of medicines, health system, and financialization of the Brazilian retail pharmacy market]. / Das farmácias comunitárias às grandes redes: provisão privada de medicamentos, sistema de saúde e financeirização no varejo farmacêutico brasileiro.

The provision of medicines in Brazil is marked by the predominance of private expenditures and supply in pharmacies and by the historically liberal regulation of retail drug sales. The first two decades of the 21st century witnessed the expansion and concentration of the retail pharmaceutical sector and growing financialization of the health sector. The article analyzes the characteristics of financialization of Brazilian retail pharmaceutical companies, considering the following three crosscutting dimensions: ownership structure, financial/accounting, and political. Quantitative and qualitative data from various sources were analyzed including ownsership and account informations of the ten biggest Brazilian retail pharmacies chains and political action of four business associations. The information collected was stored in the source project database. The ownership structure dimension revealed verticalization, diversification, capitalization via financial and shareholding operations, intensification of mergers and acquisitions, opening of pharmacy branches, entry of investors, and changes in internal management and organization. The financial/accounting dimension revealed an increase in size (revenues, assets, net worth) and good performance (return on equity capital, capital turnover, and third-party capital) of the networks compared to Brazilian companies and health companies. The policy arena revealed both clashes and collaborations between representative associations and government (Executive, Legislative, and Judiciary), depending on the issue, with outcomes that were generally favorable to the pharmaceutical sector and leadership by the Brazilian Association of Pharmacy and Drugstore Networks (Abrafarma). The financialization of the retail pharmaceutical companies' accumulation pattern and the strengthening of their political action proved relevant for understanding the changes in the provision of medicines and in the pharmaceutical market.

No Brasil a provisão de medicamentos é marcada pelo predomínio dos gastos e da oferta privada em farmácias e pela regulação historicamente liberal sobre a comercialização. Nos anos 2000 e 2010 houve expansão e concentração do varejo farmacêutico e crescente financeirização no setor saúde. O artigo analisa as expressões da financeirização em empresas do varejo farmacêutico brasileiro considerando três dimensões transversais: patrimonial, contábil-financeira e política. Foram analisados dados quantitativos e qualitativos de variadas fontes sobre as dimensões patrimonial e contábil das 10 maiores redes de farmácias brasileiras e à dimensão política da ação de quatro entidades representativas do subsetor. As informações coletadas foram reunidas no banco de dados da pesquisa fonte (Banco de Dados sobre Empresariamento na Saúde - BDES). Na dimensão patrimonial, identificou-se verticalização, diversificação, capitalização por operações financeiras e patrimoniais, intensificação de fusões e aquisições, abertura de farmácias, entrada de investidores, mudanças na gestão e organização interna. Na contábil-financeira, constatou-se aumento de porte (receitas, ativos, patrimônio) e bom desempenho (retorno sobre capital próprio, giro do ativo e capitais de terceiros) das redes em comparação à empresas brasileiras e da saúde. Na política houve embates e colaborações entre entidades e o poder público (Executivo, Legislativo e Judiciário) a depender da pauta, com desfechos geralmente favoráveis ao subsetor e protagonismo da Associação Brasileira de Farmácias e Drogarias (Abrafarma). A financeirização do padrão de acumulação de empresas do varejo farmacêutico e o fortalecimento de sua atuação política se mostraram relevantes para compreensão das mudanças na provisão de medicamentos e no setor farmacêutico.

En Brasil la provisión de medicamentos está marcada por el predominio de los gastos y oferta privada en farmacias, así como por la regulación históricamente liberal sobre su comercialización. En los años 2000 y 2010 hubo una expansión y concentración de la red minorista farmacéutica y una creciente financiarización en el sector salud. El artículo analiza las expresiones de la financiarización en empresas de la red minorista farmacéutica brasileña, considerando tres dimensiones transversales: patrimonial, contable-financiera y política. Se analizaron datos cuantitativos y cualitativos de variadas fuentes, reunidos en el banco de datos del estudio fuente, relacionados con las dimensiones patrimonial y contable de las diez mayores redes de farmacias brasileñas, y con la dimensión de la actuación política de cuatro entidades representativas del subsector. En la dimensión patrimonial, se identificaron: verticalización, diversificación, capitalización por operaciones financieras y patrimoniales, intensificación de fusiones y adquisiciones, apertura de farmacias, entrada de inversores, cambios en la gestión y organización interna. En la contable-financiera, se constató un aumento de tamaño (ingresos, activos, patrimonio) y buen desempeño (rendimiento sobre capital propio, rotación del activo y capitales de terceros) de las redes, en comparación con empresas brasileñas y de salud. En política hubo enfrentamientos y colaboraciones entre entidades y poder público (Ejecutivo, Legislativo y Judicial) dependiendo de la agenda de cada uno, con desenlaces generalmente favorables al subsector y protagonismo de la Asociación Brasileña de Farmacias y Droguerías (Abrafarma). La financiarización del patrón de acumulación de empresas en la red minorista farmacéutica y el fortalecimiento de su actuación política fueron relevantes para la comprensión de los cambios en la provisión de medicamentos y en el sector farmacéutico.

Three decades of telemedicine in Brazil: Mapping the regulatory framework from 1990 to 2018.

This study characterized the evolution of Brazilian public telemedicine policy in the Brazilian Unified Health System for 30 years from 1988 to 2019 by analyzing its legal framework. We identified 79 telemedicine-related legislations from the federal government (laws, decrees, and ordinances) and 31 regulations of federal councils of health professionals. Three historical phases were established according to the public policy cycle, and material was classified according to the purpose of the normative documents. The content analysis was based on the advocacy coalition framework model. Of the federal legislations, 8.9% were for the Formulation/Decision-Making phase, 43% for the Organization/Implementation phase, and 48.1% for the Expansion/Maturation phase of telemedicine policy in Brazil. The Federal Council of Medicine was the most active in standardizing telemedicine and was responsible for 21 (67.7%) regulations. The first legislations were passed in 2000; however, the coalitions discussed topics related to telemedicine and created their belief systems from the 1990's. The time cycle which included formulation and decision making for Brazilian telemedicine policy, extended until 2007 with the creation of several technical working groups. The expansion and maturation of telemedicine services began in 2011 with the decentralization of telemedicine policy actions across the country. Telemedicine centers which performed telediagnosis influenced the computerization of primary health care units. We conclude that Brazilian telemedicine field has greatly grown and changed in recent years. However, despite the proliferation of legislations and regulations in the period studied, there is still no fully consolidated process for setting up a wholly defined regulatory framework for telemedicine in Brazil.

Challenges and opportunities for telehealth during the COVID-19 pandemic: ideas on spaces and initiatives in the Brazilian context. / Desafios e oportunidades para telessaúde em tempos da pandemia pela COVID-19: uma reflexão sobre os espaços e iniciativas no contexto brasileiro.

COVID-19 has created enormous challenges for health systems worldwide, with the rapidly growing number of deaths and critical patients with pneumonia requiring ventilatory support. Alternative methods to control the spread of the disease such as social isolation, extreme quarantine measures, and contact tracing have been used around the world. However, these measures may not be totally effective to fight COVID-19, in step with the necessary national preparations to meet the new patient care demands. A wide range of digital technologies can be used to enhance these public health strategies, and the pandemic has sparked increasing use of telehealth. This field has grown considerably in Brazil in recent years. Still, despite the intense proliferation of recommendations and rules, until the current pandemic the country still lacked a fully consolidated regulatory framework. The emergence of COVID-19 marks a key moment in the expansion of applications and use of telehealth for improving the health system's response to the current crisis. The article discusses telehealth's contribution to the fight against COVID-19 and the recent initiatives triggered in Brazil as opportunities for the consolidation of telemedicine and improvement of the Brazilian Unified National Health System. The authors conclude that telehealth offers capabilities for remote screening, care and treatment, and assists monitoring, surveillance, detection, prevention, and mitigation of the impacts on healthcare indirectly related to COVID-19. The initiatives triggered in this process can reshape the future space of telemedicine in health services in the territory.

Correction to: Public procurement of medicines: scoping review of the scientific literature in South America.

[This corrects the article DOI: 10.1186/s40545-019-0195-9.].

Factors influencing pharmaceutical pricing - a scoping review of academic literature in health science.

INTRODUCTION: Pharmaceutical pricing has only recently gained space in mainstream health science literature. OBJECTIVES: Bibliometric and content description of health science academic literature and ad hoc analysis of grey literature on factors influencing pharmaceutical pricing on databases commonly accessed by healthcare professionals. METHODS: Scoping study with no time limits performed in Medline, Scopus and Scielo, and relevant sites and databases for grey literature, using search terms with database-appropriate keywords. RESULTS: Two hundred four articles were published in 103 peer-reviewed journals between 1981 and 2016 (last search year). In grey literature 78 documents were retrieved in the final selection. Five key thematic clusters for analysing pharmaceutical pricing emerged: market dynamics, segmented into (i) supply-related, (ii) consumer-related and (iii) product-related; (iv) trading strategies, either buyer's or seller's and (v) regulatory approach. In peer-reviewed literature there is an overall dominance of themes referring to trading strategies and regulatory approaches and a wide thematic cluster scope. Over half of this literature was produced after the year 2010. International agency technical papers make up the most significant contributions of grey literature, with a clear focus on regulatory approaches to pricing and wider consideration of emerging countries. Research lags in the literature on factors affecting pharmaceutical pricing include impacts of financing schemes, market liberalization, internet trading and biosimilars on prices, with insufficient discussion identified for the effects of discounts/rebates, profits and price transparency. CONCLUSIONS: Interest in pharmaceutical pricing literature is increasing. Robust evidence-producing study designs for pricing interventions will be a welcome development.

Brazilian generics market change after Farmácia Popular program.

OBJECTIVE: To evaluate trends in the use of generic and non-generic medicines to treat hypertension and diabetes under the Farmácia Popular Program (FP) and its impact on generic medicines sales volume and market share in the Brazilian pharmaceutical market. METHODS: This longitudinal, retrospective study used interrupted time series design to analyze changes in monthly sales volume and proportion of medicines sales (market share) for oral antidiabetic and antihypertensive medicines for generic versus non-generic products. Analyses were conducted in a combined dataset that aggregate monthly sales volumes from the Farmácia Popular program and from the QuintilesIMS™ (IQVIA) national market sales data from January 2007 to December 2012. The Farmácia Popular program phases analyzed included: a) 2009 reductions in medicines reference prices (AFP-II) and b) 2011 implementation of free medicines program for hypertension and diabetes, the Saúde não tem preço (SNTP - Health has no price). RESULTS: Patterns of use for FP-covered antidiabetic and antihypertensive medicines were similar to their use in the market in general. After one year of the decreases in government subsidies in April 2010, market share of antidiabetic and antihypertensive medicines experienced relative declines of -54.5% and -59.9%, respectively. However, when FP-covered medicines were made free to patients, overall market volume for antidiabetic and antihypertensive generics increased dramatically, with 242.6% and 277.0% relative increases by February 2012, as well as non-generics with relative increase of 209.7% and 279% for antidiabetic and antihypertensive medicines, respectively. CONCLUSIONS: Ministry of Health policies on the amount of patient cost sharing and on the choice of medicines on coverage lists have substantial impacts on overall generic sales volume in retail pharmacies.

Expenditure of biological drugs for rheumatoid arthritis treatment in the Brazilian public health system

ABSTRACT OBJECTIVE This work aims to analyze the quantity and expenses related to biological drugs used for the treatment of rheumatoid arthritis (RA) in outpatient public care within the Brazilian Unified Health System (SUS). METHODS It is a cross-sectional descriptive study based on secondary data from a historical series, referring to the purchase, volume, and the number of patients treated with different biological drugs (infliximabe, etanercept, adalimumab, rituximab, abatacept, tocilizumab, golimumab, and certolizumab pegol) for RA treatment in outpatient care from 2012 to 2017. The data were extracted from the SUS Outpatient Information System database-SIA/SUS and included ten drugs used for RA treatment. The study assessed the quantity and expenditure of these drugs, the number of RA patients treated, and the expenditure by RA subtypes. The National Broad Consumer Price Index was used to adjust the expenditures for December 2017. RESULTS The Ministry of Health allocated approximately $500 million to provide about 2 million units of biological drugs for RA patients from 2012 to 2017. The supply of adalimumab 40 mg and etanercept 50 mg accounted for 68.3% of the total expenditure. The subtypes "other rheumatoid arthritis with rheumatoid factor" (ICD-10 M05.8), "rheumatoid arthritis without rheumatoid factor" (ICD-10 M06.0), and "Felty's syndrome" (M05. 0) represented 84.5% of the total expenditures. The proportion of patients treated with biological drugs increased by 33.0%. There was a significant 83.0% increase in the number of patients using biological drugs compared to the overall number of RA patients treated during the study period. CONCLUSIONS The results obtained allow us to draw a more recent profile of expenditure on RA treatment and indicate trends in the use of biological drugs for this condition, generating data that can support management decisions in public health policies.

Reversão das recomendações emitidas pela Comissão Nacional de Incorporação de Tecnologias no SUS após Consultas Públicas / Reversal of the recommendations issued by the National Commission for the Incorporation of Technologies in SUS after Public Consultations

Resumo O trabalho analisou o efeito das Consultas Públicas (CP) e suas contribuições nas recomendações da Comissão Nacional de Incorporação de Tecnologias (CONITEC). Trata-se de estudo descritivo e retrospectivo, com abordagem qualiquantitativa, com fonte de dados secundárias de acesso público, entre 2012 e 2017. Elaborou-se banco de dados para caracterizar as CP de medicamentos e suas contribuições, o que permitiu identificar casos de reversões entre a recomendação preliminar e final da CONITEC. Analisou-se as contribuições nos casos de reversão para caracterização de eixos argumentativos e tipo de embasamento. Das 307 demandas de incorporação, 205 destes passaram por CP, com 23.894 contribuições. A reversão das recomendações ocorreu em 9% das CP abertas (15 medicamentos), todas no sentido da não incorporação para incorporação. Principais eixos argumentativos trataram de benefícios clínicos e menores eventos adversos, prevalecendo o envio de experiências clínicas e opiniões. Evidencia-se avanços nos processos de incorporação de tecnologias no SUS pela realização da CP e ficou claro o desafio que os tomadores de decisão enfrentam nos espaços institucionais para o aprimoramento da participação social no sentido de fortalecer o benefício público.

Abstract The work analyzed the effect of Public Consultations (PC) and their contributions to the recommendations of the National Commission for the Incorporation of Technologies (CONITEC). This is a descriptive and retrospective study with a qualitative-quantitative approach using a secondary data source of public access, between 2012 and 2017. A database was developed to characterize the PC of medications and their contributions, which allowed the identification of cases of reversals between the preliminary and final recommendation of CONITEC. We analyzed the contributions in cases of reversal for characterization of argumentative axes and type of basis. Of the 307 demands for incorporation of medications, 205 went through PC, with 23,894 contributions. The reversal of the recommendations occurred in 9% of the open PC (15 medications), all in the sense of non-incorporation for incorporation. Main argumentative axes dealt with clinical benefits and minor adverse events, with prevalence of the submission of clinical experiences and opinions. Advances in the processes of incorporation of technologies in the SUS by performing PC were found and the challenge that decision makers face in institutional spaces for the improvement of social participation to strengthen the public benefit was clear.

A perspectiva de egressos e de outros atores envolvidos sobre uma formação em serviços farmacêuticos na Atenção Primária à Saúde / The perspective of graduates and other stakeholders on a training on pharmaceutical services in primary health care

Objetivou-se analisar as contribuições do curso Serviços Farmacêuticos na Atenção Primária em Saúde, oferecido no município do Rio de Janeiro, especialmente quanto às suas fortalezas e fragilidades para as práticas profissionais e na gestão do trabalho, considerando a perspectiva dos egressos e de outros atores de interesse. Os dados foram obtidos no período de 11 de dezembro de 2020 a 29 de janeiro de 2021, com reunião de grupo focal e por questionário eletrônico contendo perguntas estruturadas e semiestruturadas, autorrespondido por 109 (33,2%) egressos. Foram identificadas fortalezas, como a "ampliação do conhecimento" e "melhoria da atuação e/ou conduta profissional", bem como fragilidades, como a carga horária. Ainda que com baixa carga horária e sob o desafio da compatibilização da atividade de educação continuada com a carga laboral, pode-se concluir que o curso conseguiu promover o desenvolvimento de competências em seus aspectos de ser, saber e fazer.(AU)

El objetivo fue analizar las contribuciones del curso Servicios Farmacéuticos en la Atención Primaria de la Salud, ofrecido en el municipio de Río de Janeiro, especialmente con relación a sus puntos fuertes y débiles para las prácticas profesionales y en la gestión del trabajo, considerando la perspectiva de los egresados y otros actores de interés. Los datos se obtuvieron en el período del 11/12/2020 al 29/01/2021, con reunión de grupo focal y por cuestionario electrónico, que contenía preguntas estructuradas y semiestructuradas, auto-respondido por 109 (33,2%) egresados. Se identificaron puntos fuertes como la 'ampliación del conocimiento' y la 'mejora de la actuación y/o conducta profesional' así como fragilidades, como la carga horaria. Aunque con baja carga horaria y enfrentando el desafío de la compatibilización de la actividad de la educación continuada con la carga laboral, fue posible concluir que el curso consiguió promover el desarrollo de competencias en sus aspectos de ser, saber y hacer.(AU)

The objective was to analyze the contributions of the course on Primary Health Care Services offered in the municipality of Rio de Janeiro, especially regarding strengths and weaknesses for professional practices and work management, considering the perspective of graduates and other stakeholders. Data were obtained between 12/11/2020 and 01/29/2021 from focus group meetings and electronic questionnaires containing self-reported structured and semi-structured questions, answered by 109 (33,2%) graduates. Strengths were identified, such as 'expanded knowledge' and 'improved professional performance and/or conduct', as well as weaknesses, such as the workload. Although with a low hourly workload and under the challenge of making continuing education activity compatible with the workload, it can be concluded that the course managed to promote the development of competencies in its aspects of being, knowing and doing.(AU)

Pharmaceutical Services and comprehensiveness 30 years after the advent of Brazil's Unified Health System. / Assistência Farmacêutica nos 30 anos do SUS na perspectiva da integralidade.

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.

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.

National Medicines Policy in retrospective: a review of (almost) 20 years of implementation. / Política Nacional de Medicamentos em retrospectiva: um balanço de (quase) 20 anos de implementação.

Pharmaceutical services and the formulation of a medicines policy are SUS areas ensured by the organic health care law 8,080/90. Thus, after a widely participative process, involving stakeholders, the National Medicines Policy (NMP) was approved in 1998 by Ordinance 3,916.The NMP presents directives and priorities, aligned with organic health care law, which should guide the federal, states and municipals entities actions to achieve the policy goals. Considering almost 20 years of the NMP, this paper took stock discussed some of the directives in light of the SUS principles. It was not the objective to provide an exhaustive review of all the activities performed during this period. The authors tried to get close to those that have brought advances and dilemmas, with potential risk of regression. Efforts to implement an ambitious agenda applied to pharmaceutical services were identified. This agenda tried to deal with different challenges like the dynamics of the pharmaceutical market and the operation of pharmaceutical services to guarantee the supply of medicines aligned with principles and directives of SUS.

Das farmácias comunitárias às grandes redes: provisão privada de medicamentos, sistema de saúde e financeirização no varejo farmacêutico brasileiro / From community pharmacies to big pharmacy chains: private provision of medicines, health system, and financialization of the Brazilian retail pharmacy market / De las farmacias comunitarias a las grandes redes: provisión privada de medicamentos, sistema de salud y financiarización en el sector minorista de farmacias brasileñas

No Brasil a provisão de medicamentos é marcada pelo predomínio dos gastos e da oferta privada em farmácias e pela regulação historicamente liberal sobre a comercialização. Nos anos 2000 e 2010 houve expansão e concentração do varejo farmacêutico e crescente financeirização no setor saúde. O artigo analisa as expressões da financeirização em empresas do varejo farmacêutico brasileiro considerando três dimensões transversais: patrimonial, contábil-financeira e política. Foram analisados dados quantitativos e qualitativos de variadas fontes sobre as dimensões patrimonial e contábil das 10 maiores redes de farmácias brasileiras e à dimensão política da ação de quatro entidades representativas do subsetor. As informações coletadas foram reunidas no banco de dados da pesquisa fonte (Banco de Dados sobre Empresariamento na Saúde - BDES). Na dimensão patrimonial, identificou-se verticalização, diversificação, capitalização por operações financeiras e patrimoniais, intensificação de fusões e aquisições, abertura de farmácias, entrada de investidores, mudanças na gestão e organização interna. Na contábil-financeira, constatou-se aumento de porte (receitas, ativos, patrimônio) e bom desempenho (retorno sobre capital próprio, giro do ativo e capitais de terceiros) das redes em comparação à empresas brasileiras e da saúde. Na política houve embates e colaborações entre entidades e o poder público (Executivo, Legislativo e Judiciário) a depender da pauta, com desfechos geralmente favoráveis ao subsetor e protagonismo da Associação Brasileira de Farmácias e Drogarias (Abrafarma). A financeirização do padrão de acumulação de empresas do varejo farmacêutico e o fortalecimento de sua atuação política se mostraram relevantes para compreensão das mudanças na provisão de medicamentos e no setor farmacêutico.

The provision of medicines in Brazil is marked by the predominance of private expenditures and supply in pharmacies and by the historically liberal regulation of retail drug sales. The first two decades of the 21st century witnessed the expansion and concentration of the retail pharmaceutical sector and growing financialization of the health sector. The article analyzes the characteristics of financialization of Brazilian retail pharmaceutical companies, considering the following three crosscutting dimensions: ownership structure, financial/accounting, and political. Quantitative and qualitative data from various sources were analyzed including ownsership and account informations of the ten biggest Brazilian retail pharmacies chains and political action of four business associations. The information collected was stored in the source project database. The ownership structure dimension revealed verticalization, diversification, capitalization via financial and shareholding operations, intensification of mergers and acquisitions, opening of pharmacy branches, entry of investors, and changes in internal management and organization. The financial/accounting dimension revealed an increase in size (revenues, assets, net worth) and good performance (return on equity capital, capital turnover, and third-party capital) of the networks compared to Brazilian companies and health companies. The policy arena revealed both clashes and collaborations between representative associations and government (Executive, Legislative, and Judiciary), depending on the issue, with outcomes that were generally favorable to the pharmaceutical sector and leadership by the Brazilian Association of Pharmacy and Drugstore Networks (Abrafarma). The financialization of the retail pharmaceutical companies' accumulation pattern and the strengthening of their political action proved relevant for understanding the changes in the provision of medicines and in the pharmaceutical market.

En Brasil la provisión de medicamentos está marcada por el predominio de los gastos y oferta privada en farmacias, así como por la regulación históricamente liberal sobre su comercialización. En los años 2000 y 2010 hubo una expansión y concentración de la red minorista farmacéutica y una creciente financiarización en el sector salud. El artículo analiza las expresiones de la financiarización en empresas de la red minorista farmacéutica brasileña, considerando tres dimensiones transversales: patrimonial, contable-financiera y política. Se analizaron datos cuantitativos y cualitativos de variadas fuentes, reunidos en el banco de datos del estudio fuente, relacionados con las dimensiones patrimonial y contable de las diez mayores redes de farmacias brasileñas, y con la dimensión de la actuación política de cuatro entidades representativas del subsector. En la dimensión patrimonial, se identificaron: verticalización, diversificación, capitalización por operaciones financieras y patrimoniales, intensificación de fusiones y adquisiciones, apertura de farmacias, entrada de inversores, cambios en la gestión y organización interna. En la contable-financiera, se constató un aumento de tamaño (ingresos, activos, patrimonio) y buen desempeño (rendimiento sobre capital propio, rotación del activo y capitales de terceros) de las redes, en comparación con empresas brasileñas y de salud. En política hubo enfrentamientos y colaboraciones entre entidades y poder público (Ejecutivo, Legislativo y Judicial) dependiendo de la agenda de cada uno, con desenlaces generalmente favorables al subsector y protagonismo de la Asociación Brasileña de Farmacias y Droguerías (Abrafarma). La financiarización del patrón de acumulación de empresas en la red minorista farmacéutica y el fortalecimiento de su actuación política fueron relevantes para la comprensión de los cambios en la provisión de medicamentos y en el sector farmacéutico.

Farmácia Popular Program: pharmaceutical market analysis of antihypertensive acting on the renin-angiotensin system medicines.

This paper aims to analyse changes in the retail pharmaceutical market following policy changes in the Farmácia Popular Program (FP), a medicines subsidy program in Brazil. The retrospective longitudinal analyses focus on therapeutic class of agents acting on the renin-angiotensin system. Data obtained from QuintilesIMS (formerly IMS Health) included private retail pharmacy sales volume (pharmaceutical units) and sales values from 2002 to 2013. Analyses evaluated changes in market share following key FP policy changes. The therapeutic class was selected due to its relevance to hypertension treatment. Market share was analysed by therapeutic sub-classes and by individual company. Losartan as a single product accounted for the highest market share among angiotensin II antagonists. National companies had higher sales volume during the study period, while multinational companies had higher sales value. Changes in pharmaceutical market share coincided with the inclusion of specific products in the list of medicines covered by FP and with increases in or exemption from patient copayment.

Incorporation of new medicines by the National Commission for Incorporation of Technologies, 2012 to June 2016. / Incorporação de novos medicamentos pela Comissão Nacional de Incorporação de Tecnologias do SUS, 2012 a junho de 2016.

The National Commission for incorporation of Health Technologies (CONITEC), established in 2011, advises the Ministry of Health in decisions related to the incorporation, exclusion or change of medicines, products and procedures in the Unified Health System (SUS).The study investigated the decision-making process, profile of demands and incorporation of new medicines in the SUS from January/2012 to June/2016, based on data available on the CONITEC website. All submissions were evaluated and characterized by technology and applicant type. The incorporations were analyzed according to the Anatomical-Therapeutic-Chemical classification, International Classification of Disease of the clinical indication and active record in the National Health Surveillance Agency. In the period, 485 submissions were received, 92.2% concerning requests for incorporation and 62.1% for medicines, of which 93 (30.1%) received a favorable recommendation for incorporation. Domestic demands were more successful than externally originated ones. Six unregistered drugs were incorporated. Infectious and parasitic diseases and musculoskeletal diseases constituted the main clinical indications. The recommendation of incorporation occurred mainly based on the additional clinical benefits and low budget impact.

Costs of Public Pharmaceutical Services in Rio de Janeiro Compared to Farmácia Popular Program.

OBJECTIVE: To analyze the costs of public pharmaceutical services compared to Farmácia Popular Program (Popular Pharmacy Program). METHODS: Comparison between prices paid by Aqui Tem Farmácia Popular Program (Farmácia Popular is available here) with the full costs of medicine provision by the Municipal Health Department of Rio de Janeiro. The comparison comprised 25 medicines supplied by both the municipal pharmaceutical service and Aqui Tem Farmácia Popular Program. Calculating the cost per pharmaceutical unit of each medicine included expenditure by Municipal Health Department of Rio de Janeiro with procurement (price), logistics, and local dispensation. The reference price of medicines paid by Aqui Tem Farmácia Popular was taken from the Brazilian Ministry of Health standard in force in 2012. Comparisons included full reference price; reference price minus 10.0% copayment by users; and maximum reference paid by the Ministry of Health (minus copayment and taxes). Simulations were carried out of the differences between the costs of Municipal Health Department of Rio de Janeiro with the common medicines and those potentially incurred based on the reference price of Aqui Tem Farmácia Popular. RESULTS: The Municipal Health Department of Rio de Janeiro spent R$28,526,526.57 with 25 medicines of the common list in 2012; 58.7% accounted for direct procurement costs. The estimated costs of the Health Department were generally lower than the reference prices of the Aqui Tem Farmácia Popular Program for 20 medicines, regardless of reference prices. The potential costs incurred by Health Department if expenditure of its consumption pattern were based on the reference prices of Aqui Tem Farmácia Popular would be R$124,170,777.76, considering the best scenario of payment by the Brazilian Ministry of Health (90.0% of the reference price, minus taxes). CONCLUSIONS: The difference in costs between public provision by Municipal Health Department of Rio de Janeiro and Farmácia Popular Program indicates that some reference prices could be reviewed aiming at their reduction. OBJETIVO: Analisar custos da assistência farmacêutica pública frente ao Programa Farmácia Popular. MÉTODOS: Comparação entre os valores pagos pelo Programa Aqui Tem Farmácia Popular com os custos integrais relativos à provisão de medicamentos pela Secretaria Municipal de Saúde do Rio de Janeiro. A comparação compreendeu 25 medicamentos, comuns tanto à provisão pela assistência farmacêutica pública municipal quanto pelo Programa Aqui Tem Farmácia Popular. O cálculo do custo unitário por unidade farmacotécnica de cada medicamento envolveu os gastos da Secretaria Municipal de Saúde com custos de aquisição (preço), logísticos e com a dispensação em nível local. O valor de referência dos medicamentos pago pelo Aqui Tem Farmácia Popular foi extraído da norma ministerial em vigor em 2012. As comparações envolveram o valor de referência pleno; valor de referência com desconto dos 10,0% pagos de contrapartida pelos usuários; e valor de referência máximo pago pelo Ministério da Saúde (descontados contrapartida e sem impostos).Foram realizadas simulações das diferenças entre os gastos da Secretaria Municipal de Saúde do Rio de Janeiro com os medicamentos do elenco comum e os que seriam incorridos se esses tivessem sido executados com base no valor de referência do Aqui Tem Farmácia Popular. RESULTADOS: A Secretaria Municipal de Saúde do Rio de Janeiro gastou R$28.526.526,57 com 25 medicamentos do rol comum em 2012; 58,7% corresponderam a custos diretos com a aquisição dos produtos. Os custos estimados da Secretaria Municipal de Saúde do Rio de Janeiro foram, em geral, menores que os valores de referência do Programa Aqui Tem Farmácia Popular em 20 medicamentos, independentemente dos valores de referência. Os custos que seriam incorridos pela Secretaria Municipal de Saúde do Rio de Janeiro, caso seu padrão de consumo tivesse como valor de pagamento os valores de referência do Aqui Tem Farmácia Popular seriam de R$124.170.777,76 considerando a melhor situação de pagamento pelo Ministério da Saúde (90,0% do valor de referência, com impostos descontados). CONCLUSÕES: A diferença de custos entre a provisão pública pela Secretaria Municipal de Saúde do Rio de Janeiro e o Programa Aqui Tem Farmácia Popular sinaliza que alguns valores de referência poderiam ser objetos de exame para sua redução.

Pharmaceutical services in Rio de Janeiro Municipality, Brazil: development regarding selected aspects from 2008 to 2014. / Assistência farmacêutica no município do Rio de Janeiro, Brasil: evolução em aspectos selecionados de 2008 a 2014.

This article aims to analyze the development of pharmaceutical services in the context of the primary health care (PHC) in the period 2008- 2014, focusing on selection, procurement and financing of medicines. A retrospective study was undertaken, using as data sources administrative documents of Rio de Janeiro Municipality Health Secretariat (SMS-RJ) as well as secondary database. We found a growth of numbers medicines offered for PHC of 57 items in 2008 to 222 in 2014. Actual spending on drugs paid by the city has grown 38% in the period, with a reversal from 2010, of the proportion of PHC related to tertiary care drugs, reaching 2.4 times in 2014, the year that public spending on medicines per capita of PHC was 9% greater than the value agreed between the three federal levels. It can be concluded that there have been important changes in pharmaceutical services in Rio de Janeiro Municipality in the period following the reform of PHC held in this territory, with increasing the conditions for therapeutic coverage and increased drug funding. The growth of per capita public spending on medicines above the agreed value raises the need to strengthen the rationalization of management measures.