Abstract

This case study aimed to characterize the Specialized Component of Pharmaceutical Services (CEAF) organization in four Brazilian states from diverse regions of the country. Data were collected with representatives of CEAF management from states in different regions, who answered a 21-question questionnaire on scope, organization, financing, hurdles, and facilitators. This information was complemented with data from national health surveys, DataSUS, the applied resources, and socioeconomic indicators. Differences were observed between states on issues such as the proportion of users and the decentralization of services. These characteristics seem to be related to the level of development concerning the socioeconomic indicators used. Advances in access to medicines were highlighted, despite the difficulties complying with the CEAF’s objectives, such as insufficient resources, the qualification of human resources, and the provision of necessary visits and exams. The results point to advances, different forms of organization and highlight the need for more in-depth studies on the clinical and economic outcomes achieved as a strategy to outline solutions to achieve the comprehensive and equal care for users.

Key words:
Pharmaceutical care; Access to health services; High-cost technology; Essential medicines

Introduction

Medicines play an important role in health care. However, the increasing costs of therapeutic alternatives incorporated in health systems require strategies to guarantee access and completeness of treatments. This aspect has concerned researchers and managers of health systems, including in developed countries¹1 Brasil. Ministério da Saúde (MS). Secretaria de Ciência, Tecnologia e Insumos Estratégicos. Departamento de Assistência Farmacêutica e Insumos Estratégicos. Assistência Farmacêutica no SUS: 20 anos de políticas e propostas para desenvolvimento e qualificação: relatório com análise e recomendações de gestores, especialistas e representantes da sociedade civil organizada [recurso eletrônico]. Brasília: MS; 2018. 125 p.: il.

2 Lu CY, Williams KM, Day RO. The funding and use of high-cost medicines in Australia: the example of anti-rheumatic biological medicines. Aust N Z Health Policy 2007; 4(1):2.

3 Bevan G, Helderman J-K, Wilsford D. Changing choices in health care: implications for equity, efficiency and cost. Health Econ Policy Law 2010;5(3):251-267.

4 Vargas-Peláez CM, Rover MRM, Leite SN, Rossi Buenaventura F, Farias MR. Right to health, essential medicines, and lawsuits for access to medicines - A scoping study. Soc Sci Med 2014; 121:48-55.

5 Fondo Nacional de Recursos. Política y gestión de la cobertura de medicamentos de alto costo. Relevamiento de la experiencia internacional y respuesta del Fondo Nacional de Recursos [Internet]. Primera. Montevideo: FNR; 2010. (Publicación Técnica). [acceso 2020 Abr 25]. Disponible en: http://www.fnr.gub.uy/sites/default/files/publicaciones/FNR_publicacion_tecnica_13.pdf^-66 Paim J, Travassos C, Almeida C, Bahia L, Macinko J. The Brazilian health system: history, advances, and challenges. The Lancet 2011; 377(9779):1778-1797..

Brazil has implemented different public policies⁷7 Brasil. Conselho Nacional de Saúde. Resolução no 338 de 6 de maio de 2004. Aprova a Política Nacional de Assistência Farmacêutica [Internet]. maio 6, 2004. [acessado 2020 abr 23]. Disponível em: http://repositorio.ufpe.br/handle/123456789/9696
http://repositorio.ufpe.br/handle/123456...

8 Brasil. Ministério da Saúde (MS). Da Excepcionalidade às Linhas de Cuidado: O Componente Especializado da Assistência Farmacêutica [Internet]. 1ª ed. Brasilia: MS; 2010 [acessado 2015 nov 5]. Disponível em: http://bvsms.saude.gov.br/bvs/publicacoes/excepcionalidade_linhas_cuidado_ceaf.pdf^-99 Brasil. Ministério da Saúde (MS). Portaria de Consolidação no 2 de 28 de setembro de 2017. Consolidação das normas sobre as políticas nacionais de saúde do Sistema Único de Saúde (SUS). [Internet]. [acessado 2020 maio 4]. Disponível em: https://bvsms.saude.gov.br/bvs/saudelegis/gm/2017/MatrizesConsolidacao/Matriz-2-Politicas.html
https://bvsms.saude.gov.br/bvs/saudelegi... to ensure access and rational use of medicines (RUM). Among the strategies for expanding access, the Specialized Component of Pharmaceutical Services (CEAF) was implemented to achieve comprehensive treatment based on lines of care defined in the Clinical Protocols and Therapeutic Guidelines (PCDT/MS), which define the algorithm and treatment and the diagnostic criteria and clinical monitoring mechanisms⁸8 Brasil. Ministério da Saúde (MS). Da Excepcionalidade às Linhas de Cuidado: O Componente Especializado da Assistência Farmacêutica [Internet]. 1ª ed. Brasilia: MS; 2010 [acessado 2015 nov 5]. Disponível em: http://bvsms.saude.gov.br/bvs/publicacoes/excepcionalidade_linhas_cuidado_ceaf.pdf^,99 Brasil. Ministério da Saúde (MS). Portaria de Consolidação no 2 de 28 de setembro de 2017. Consolidação das normas sobre as políticas nacionais de saúde do Sistema Único de Saúde (SUS). [Internet]. [acessado 2020 maio 4]. Disponível em: https://bvsms.saude.gov.br/bvs/saudelegis/gm/2017/MatrizesConsolidacao/Matriz-2-Politicas.html
https://bvsms.saude.gov.br/bvs/saudelegi... . While Brazil does not adopt a parameter to define allegedly high-cost (as in the English health system) or high-priced medicines¹⁰10 Bermudez JAZ, Oliveira MA, Chaves GC. Novos medicamentos: quem poderá pagar? Cad Saude Publica 2016; 32 (Supl. 2):e00025215., the CEAF facilitates the highest mean price of outpatient medicines in the SUS, including the most recently incorporated by CONITEC, such as Ecolizumab¹¹11 Caetano R, Rodrigues PHA, Corrêa MCV, Villardi P, Osorio-de-Castro CGS. O caso do eculizumabe: judicialização e compras pelo Ministério da Saúde. Rev Saude Publica 2020; 54:22..

The use of the terms “high-cost medicines” or “high-priced” has not yet been defined internationally and may vary in the same country¹²12 Wahlster P, Scahill S, Lu CY, Babar ZUD. Barriers to access and use oh high cost medicines: a review. Heal Policy Technol 2015; 4:191-214.. Some countries categorize high-cost medicines by the price cap per patient or year to be reimbursed by the public payer. These medicines generally have a monopoly patent and represent a significant financial burden for the public health care system or greater direct expenses for individuals¹³13 Hasan SS, Lu CY. Access to High Cost Medicines: An Overview. Chapter 1. Elsevier Inc; 2018..

The financing of CEAF medicines is tripartite. However, those indicated for more complex diseases, with high financial impact and included in actions of the Health Industrial Complex, are acquired centrally by the Ministry of Health or financed by it through the transfer of resources to the states⁸8 Brasil. Ministério da Saúde (MS). Da Excepcionalidade às Linhas de Cuidado: O Componente Especializado da Assistência Farmacêutica [Internet]. 1ª ed. Brasilia: MS; 2010 [acessado 2015 nov 5]. Disponível em: http://bvsms.saude.gov.br/bvs/publicacoes/excepcionalidade_linhas_cuidado_ceaf.pdf^,99 Brasil. Ministério da Saúde (MS). Portaria de Consolidação no 2 de 28 de setembro de 2017. Consolidação das normas sobre as políticas nacionais de saúde do Sistema Único de Saúde (SUS). [Internet]. [acessado 2020 maio 4]. Disponível em: https://bvsms.saude.gov.br/bvs/saudelegis/gm/2017/MatrizesConsolidacao/Matriz-2-Politicas.html
https://bvsms.saude.gov.br/bvs/saudelegi... .

Following the SUS management principles, the underlying steps of CEAF’s implementation are decentralized, and the State Health Secretariats (SES) are responsible for organizing services to attend to people, including dispensing medicines. However, some activities can be carried out by the municipal public service network, as long as there is an agreement between the managers⁹9 Brasil. Ministério da Saúde (MS). Portaria de Consolidação no 2 de 28 de setembro de 2017. Consolidação das normas sobre as políticas nacionais de saúde do Sistema Único de Saúde (SUS). [Internet]. [acessado 2020 maio 4]. Disponível em: https://bvsms.saude.gov.br/bvs/saudelegis/gm/2017/MatrizesConsolidacao/Matriz-2-Politicas.html
https://bvsms.saude.gov.br/bvs/saudelegi... .

In this context, Rover et al.¹⁴14 Rover MRM, Vargas-Pelaez CM, Rocha Farias M, Nair Leite S. Acceso a medicamentos de alto precio en Brasil: la perspectiva de médicos, farmacéuticos y usuarios. Gac Sanit 2016; 30(2):110-116.

15 Rover MRM, Vargas-Pelaez CM, Farias MR, Leite SN. Da organização do sistema à fragmentação do cuidado: A percepção de usuários, médicos e farmacêuticos sobre o Componente Especializado da Assistência Farmacêutica em um estado do sul do Brasil. Physis 2016; 26(2):691-711.^-1616 Rover MRM, Vargas-Pelaez CM, Faraco EB, Farias MR, Leite SN. Avaliação da capacidade de gestão do componente especializado da assistência farmacéutica. Cien Saude Colet 2017; 22(8):2487-2499. highlight that several factors can influence CEAF’s management and that ensuring complete treatments involves access to medication and other care and health services and the articulation between these¹⁴14 Rover MRM, Vargas-Pelaez CM, Rocha Farias M, Nair Leite S. Acceso a medicamentos de alto precio en Brasil: la perspectiva de médicos, farmacéuticos y usuarios. Gac Sanit 2016; 30(2):110-116.. The authors argue that the lack of interrelationship of Pharmaceutical Care with other health sectors, which translates, for example, into the mismatch between the demand for CEAF-related services and their offer by the state results in a fragmented care¹⁵15 Rover MRM, Vargas-Pelaez CM, Farias MR, Leite SN. Da organização do sistema à fragmentação do cuidado: A percepção de usuários, médicos e farmacêuticos sobre o Componente Especializado da Assistência Farmacêutica em um estado do sul do Brasil. Physis 2016; 26(2):691-711.^,1616 Rover MRM, Vargas-Pelaez CM, Faraco EB, Farias MR, Leite SN. Avaliação da capacidade de gestão do componente especializado da assistência farmacéutica. Cien Saude Colet 2017; 22(8):2487-2499..

The Federal Government’s investments to finance the Component have been on the rise¹1 Brasil. Ministério da Saúde (MS). Secretaria de Ciência, Tecnologia e Insumos Estratégicos. Departamento de Assistência Farmacêutica e Insumos Estratégicos. Assistência Farmacêutica no SUS: 20 anos de políticas e propostas para desenvolvimento e qualificação: relatório com análise e recomendações de gestores, especialistas e representantes da sociedade civil organizada [recurso eletrônico]. Brasília: MS; 2018. 125 p.: il.^,1717 Brasil. Ministério da Saúde (MS). Componente Especializado da Assistência Farmacêutica: inovação para a garantia do acesso a medicamentos no SUS [Internet]. 1o ed. Brasilia: MS; 2014 [acessado 2015 nov 5]. Disponível em: http://portalsaude.saude.gov.br/images/pdf/2014/dezembro/16/livro-2-completo-para-site.pdf^,1818 Brasil. Lei no 13.255, de 14 de janeiro de 2016. Estima a receita e fixa a despesa da União para o exercício financeiro de 2016 [Internet]. [acessado 2020 abr 25]. Disponível em: http://www.planalto.gov.br/ccivil_03/_Ato2015-2018/2016/Lei/L13255.htm
http://www.planalto.gov.br/ccivil_03/_At... since CEAF’s implementation. However, few studies have been carried out regarding its organization and management, the results achieved, and its coverage in different Brazilian states and regions, considering the known inequalities.

Thus, considering the differences between the structures of pharmaceutical care in the country, people question which aspects still need to be improved to achieve CEAF’s objectives. In this sense, this study aimed to characterize the different forms of organization, management, and access to medicines in the CEAF in four states in different regions of the country and their relationship with socioeconomic and health indicators.

Methods

This case study was developed with data collected from 2014 and 2015. Data were retrieved from questionnaires and secondary databases. Participating states were selected by convenience sampling using the managers’ availability to respond as a criterion. Invitations to participate in the study were sent by e-mail to six states and the Federal District. Five of them and the Federal District agreed to participate, and four states were included in this study as they showed all the necessary data. Participating managers answered the questionnaires and sent them by e-mail.

The questionnaire was developed from the guidelines provided for in the PCDT and Component’s regulations⁸8 Brasil. Ministério da Saúde (MS). Da Excepcionalidade às Linhas de Cuidado: O Componente Especializado da Assistência Farmacêutica [Internet]. 1ª ed. Brasilia: MS; 2010 [acessado 2015 nov 5]. Disponível em: http://bvsms.saude.gov.br/bvs/publicacoes/excepcionalidade_linhas_cuidado_ceaf.pdf^,99 Brasil. Ministério da Saúde (MS). Portaria de Consolidação no 2 de 28 de setembro de 2017. Consolidação das normas sobre as políticas nacionais de saúde do Sistema Único de Saúde (SUS). [Internet]. [acessado 2020 maio 4]. Disponível em: https://bvsms.saude.gov.br/bvs/saudelegis/gm/2017/MatrizesConsolidacao/Matriz-2-Politicas.html
https://bvsms.saude.gov.br/bvs/saudelegi... and validated through discussions with the research group until reaching a consensus on the most relevant issues for the study. The consensus questionnaire consisted of 20 questions (9 open-ended and 11 closed-ended) related to: scope (e.g., number of users); CEAF’s organization (e.g., decentralized, municipalized); financing (e.g., amounts invested); infrastructure (e.g., number of units, reference centers - RC/application poles); logistical and clinical services (e.g., procurement problems and monitoring provided for in the PCDT); open-ended questions about the perception of facilitators and weaknesses in the state’s CEAF management.

The following data were collected from each state: population, Gross Domestic Product (GDP), Municipal Human Development Index (MHDI)¹⁹19 Brasil. Instituto Brasileiro de Geografia e Estatística (IBGE). Estados@ [Internet]. 2014 [acessado 2014 nov 18]. Disponível em: http://www.ibge.gov.br/estadosat/perfil.php
http://www.ibge.gov.br/estadosat/perfil.... ^,2020 Brasil. Instituto Brasileiro de Geografia e Estatística (IBGE). Índice de Desenvolvimento Humano Municipal - IDHM. Brasília: IBGE; 2010. [acessado 2014 nov 18]. Disponível em: http://www.ibge.gov.br/estadosat/temas.php?sigla=&tema=idhm, and SUS Development Index (IDSUS)²¹21 Brasil. Ministério da Saúde (MS). Índice de Desempenho do Sistema Único de Saúde (IDSUS). Brasília: MS; 2011 [Internet]. [acessado 2014 nov 18]. Disponível em: http://idsus.saude.gov.br/mapas.html. The GDP and IDSUS data were categorized into three groups by descending state ranking order: upper tertile (1^st to 9^th), middle tertile (10^th to 18^th), lower tertile (19^th to 27^th). In the case of the MHDI, the classification was as follows: very low = 0-0.499; low = 0.500-0.599; average = 0.600-0.699; high = 0.700-0.799; very high >0.800²⁰20 Brasil. Instituto Brasileiro de Geografia e Estatística (IBGE). Índice de Desenvolvimento Humano Municipal - IDHM. Brasília: IBGE; 2010. [acessado 2014 nov 18]. Disponível em: http://www.ibge.gov.br/estadosat/temas.php?sigla=&tema=idhm.

Additionally, data were collected from the indicators of access to health services and medicines from the National Health Survey²²22 Fundação Oswaldo Cruz (Fiocruz). Pesquisa nacional de saúde. [página de Internet]. [acessado 2015 nov 15]. Disponível em: http://www.icict. fiocruz.br/sites/www.icict.fiocruz.br/files/PNS%20 Vol%202.pdf
http://www.icict. fiocruz.br/sites/www.i... (% of the population that accesses all medicines, % of the population that accesses medical appointments, and % of the population with a private health plan) and DataSUS data²³23 Brasil. Ministério da Saúde (MS). Banco de dados do Sistema Único de Saúde - DATASUS. Brasília: MS; 2016. [acessado 2016 maio 26]. Disponível em: http://www2.datasus.gov.br/DATASUS/index.php (% of resources invested by States EC29 - in health). The amounts invested by the Ministry of Health in CEAF in each state were also considered, per the corresponding ordinances²⁴24 Brasil. Ministério da Saúde (MS). Portaria no 122, de 31 de janeiro de 2013. Aprova o repasse de recursos para Estados e Distrito Federal, a título de financiamento, referente a janeiro, fevereiro e março de 2013, para aquisição de medicamentos do Componente Especializado da Assistência Farmacêutica, conforme Tabela de Procedimentos, Medicamentos, Órteses, Próteses e Materiais Especiais do Sistema Único de Saúde. Brasília: MS; 2013. [acessado 2016 maio 26]. Disponível em: http://bvsms.saude.gov.br/bvs/saudelegis/gm/2013/prt0122_31_01_2013.html

25 Brasil. Ministério da Saúde (MS). Portaria no 757, de 6 de maio de 2013. Aprova o repasse de recursos para Estados e Distrito Federal, a título de financiamento, referente a abril, maio e junho de 2013, para aquisição de medicamentos do Componente Especializado da Assistência Farmacêutica, conforme Tabela de Procedimentos, Medicamentos, Órteses, Próteses e Materiais Especiais do Sistema Único de Saúde. Brasília: MS; 2013. [acessado maio 6, 2013. [acessado 2016 maio 26]. Disponível em: http://bvsms.saude.gov.br/bvs/saudelegis/gm/2013/prt0757_06_05_2013.html

26 Brasil. Ministério da Saúde (MS). Portaria no 1.659, de 8 de agosto de 2013. Aprova o repasse de recursos para Estados e Distrito Federal, a título de financiamento, referente a julho, agosto e setembro de 2013, para aquisição de medicamentos do Componente Especializado da Assistência Farmacêutica conforme Tabela de Procedimentos, Medicamentos, Órteses, Próteses e Materiais Especiais do Sistema Único de Saúde. Brasília: MS; 2013. [acessado 2016 maio 26]. Disponível em: http://bvsms.saude.gov.br/bvs/saudelegis/gm/2013/prt1659_08_08_2013.html^-2727 Brasil. Ministério da Saúde (MS). Portaria no 2.701, de 11 de novembro de 2013. Aprova o repasse de recursos para os Estados e Distrito Federal, a título de financiamento, referente a outubro, novembro e dezembro de 2013, para aquisição de medicamentos do Componente Especializado da Assistência Farmacêutica conforme Tabela de Procedimentos, Medicamentos, Órteses, Próteses e Materiais Especiais do Sistema Único de Saúde. Brasília: MS; 2013. [acessado 2016 maio 26]. Disponível em: http://bvsms.saude.gov.br/bvs/saudelegis/gm/2013/prt2701_11_11_2013.html.

The exchange rate reported by the Central Bank of Brazil (BRL 2.34 per U.S. Dollar) was used for converting BRL to U.S. dollars. The answers to the open questions were analyzed and categorized, following the steps of treatment and analysis of qualitative data by Pope et al.²⁸28 Pope C, Ziebland S, Mays N. Analysing qualitative data. BMJ 2000; 320(7227):114-116.. The Human Research Ethics Committee of the Federal University of Santa Catarina approved this study under Opinion No. 712.031/2014.

Results

The management representatives participating in the survey were pharmacists with statutory employment and with two years or more of experience in the position. The population of the four states together represented approximately 35% of the Brazilian population. Table 1 shows the MHDI, the GDP, the IDSUS, and indicators of access to medicines, appointments, and health plans. We can observe that the analyzed states showed differences in the MHDI, IDSUS, and GDP indicators, which coincided with the data on the indicators of access to medicines and health services.

The states with higher GDP, MHDI, and IDSUS (South and Southeast) also had greater access to medicines, appointments, and private health insurance. Specifically concerning the CEAF, we observed differences in funding, the proportion of users per inhabitant, and the organization of the Component (decentralization of dispensing locations) (Table 2 and 3).

Information on financing for the purchase of medicines showed that the highest (absolute) amounts of resources are transferred by the Federal Government the states with the highest number of users (South and Southeast). In turn, the other two states had the highest proportional expenditure on medicine financing.

The proportion of people served by CEAF was higher in the South and lower in the North. Differences in the degree of decentralization of the Component (understood as a more significant number of dispensing locations) were also highlighted. They were more significant in the states of the South and Southeast. The data showed greater availability of medical centers in the Southeastern state.

The participants said that the implementation of CEAF had weaknesses in different stages, both in the logistical and care processes and in articulation with the municipalities, as categorized in Chart 1. Examples are the lack of information about the first line of care service in some states; the pent-up demand due to the centralized purchase schedule being made without technical reserve; the long time to evaluate requests; weaknesses in the provision of appointments with experts and tests (when required) for access to medicines. Also, according to the participants, there was a need to centralize the purchase of other drugs, mainly due to the economic impact they represented and because the amounts transferred by the Ministry of Health were insufficient. However, strengths were also described, such as the expanded access to medicines, the incorporation of new technologies, and the increased number of clinical conditions for which the public sector provides the treatment. The main weaknesses and strengths described are presented in Chart 1.

It should be noted that the short period of renewal of requests for chronic diseases (quarterly) and the lack of data on the clinical and economic results achieved were also highlighted by the participants.

Discussion

National surveys have identified that access to medicines, including the public and private sectors, has evolved consistently in Brazil¹1 Brasil. Ministério da Saúde (MS). Secretaria de Ciência, Tecnologia e Insumos Estratégicos. Departamento de Assistência Farmacêutica e Insumos Estratégicos. Assistência Farmacêutica no SUS: 20 anos de políticas e propostas para desenvolvimento e qualificação: relatório com análise e recomendações de gestores, especialistas e representantes da sociedade civil organizada [recurso eletrônico]. Brasília: MS; 2018. 125 p.: il.^,2929 Brasil. Ministério da Saúde (MS). Pesquisa Nacional sobre Acesso, Utilização e promoção do uso racional de Medicamentos no Brasil, PNAUM: Primeiros Resultados Brasília: MS; 2015. [acessado 2016 maio]. Disponível em: http://www.ufrgs.br/pnaum/projeto-1/arquivos/pnaum-primeiros-resultados due to public policies implemented in recent years⁸8 Brasil. Ministério da Saúde (MS). Da Excepcionalidade às Linhas de Cuidado: O Componente Especializado da Assistência Farmacêutica [Internet]. 1ª ed. Brasilia: MS; 2010 [acessado 2015 nov 5]. Disponível em: http://bvsms.saude.gov.br/bvs/publicacoes/excepcionalidade_linhas_cuidado_ceaf.pdf. In this context, the participants highlighted CEAF’s positive results regarding expanding the list, constructing lines of care, and increasing the number of users served as the main strengths. However, the findings of this study show that the results between the states are not homogeneous and that there are still difficulties for the full implementation of the Component.

The heterogeneity observed in the organization for servicing users, and the number of users is related to the contextual differences of the states and management capacity, as the performance of health systems is primarily influenced by the local political, socioeconomic, and cultural characteristics³⁰30 Sheikh K, Gilson L, Agyepong IA, Hanson K, Ssengooba F, Bennett S. Building the Field of Health Policy and Systems Research: Framing the Questions. PLoS Med 2011; 8(8):e1001073.^,3131 Paina L, Peters DH. Understanding pathways for scaling up health services through the lens of complex adaptive systems. Health Policy Plan 2012;27(5):365-373.. Moreover, access to medicines is highly dependent on the organization and functioning of health systems also at the local level³²32 Bigdeli M, Jacobs B, Tomson G, Laing R, Ghaffar A, Dujardin B, Damme WV. Access to medicines from a health system perspective. Health Policy Plan 2013; 28(7):692-704..

In this sense, the results of this study indicate that, while the PCDT are national guidelines, the states in the South and Southeast had a higher proportion of users served by CEAF, states with greater availability of economic resources (greater GDP), public services (greater IDSUS), and broader coverage of private health plans. The inverse association between socioeconomic position and underutilization of medications was previously observed in Brazil and corroborates the findings of Luz et al.³³33 Luz TCB, Loyola Filho AI, Lima-Costa MF. Estudo de base populacional da subutilização de medicamentos por motivos financeiros entre idosos na Região Metropolitana de Belo Horizonte, Minas Gerais, Brasil. Cad Saude Publica 2009; 25(7):1578-1586..

Although Penchansky and Thomas³⁴34 Penchansky R, Thomas JW. The concept of access: definition and relationship to consumer satisfaction. Med Care 1981;19(2):127-140. believe that service accessibility is determined by the relationship between the volume and type of service available, and the volume and type of user needs, the results corroborate the first statement but do not allow us to state that the lower access to CEAF in the North and Northeast were the result of lesser need since there is no epidemiological data to indicate this hypothesis.

It is also known that, while Brazil has made significant advances regarding access to health services, especially in Primary Health Care, the limited provision of high- and medium-complexity services required to meet the criteria established by the PCDT is still a significant challenge for the public sector of the SUS¹1 Brasil. Ministério da Saúde (MS). Secretaria de Ciência, Tecnologia e Insumos Estratégicos. Departamento de Assistência Farmacêutica e Insumos Estratégicos. Assistência Farmacêutica no SUS: 20 anos de políticas e propostas para desenvolvimento e qualificação: relatório com análise e recomendações de gestores, especialistas e representantes da sociedade civil organizada [recurso eletrônico]. Brasília: MS; 2018. 125 p.: il.^,66 Paim J, Travassos C, Almeida C, Bahia L, Macinko J. The Brazilian health system: history, advances, and challenges. The Lancet 2011; 377(9779):1778-1797.^,3535 Silva AAS, Costa SMC. A descentralização do componente especializado da assistência farmacêutica na 15ª região de saúde do estado do Ceará. RBFHSS 2015; 6(1):37-40.. These constraints cause long waiting times, leading to a search for specialized care in the private sector or through the courts, which burdens the state even more⁴4 Vargas-Peláez CM, Rover MRM, Leite SN, Rossi Buenaventura F, Farias MR. Right to health, essential medicines, and lawsuits for access to medicines - A scoping study. Soc Sci Med 2014; 121:48-55.^,1414 Rover MRM, Vargas-Pelaez CM, Rocha Farias M, Nair Leite S. Acceso a medicamentos de alto precio en Brasil: la perspectiva de médicos, farmacéuticos y usuarios. Gac Sanit 2016; 30(2):110-116.

15 Rover MRM, Vargas-Pelaez CM, Farias MR, Leite SN. Da organização do sistema à fragmentação do cuidado: A percepção de usuários, médicos e farmacêuticos sobre o Componente Especializado da Assistência Farmacêutica em um estado do sul do Brasil. Physis 2016; 26(2):691-711.^-1616 Rover MRM, Vargas-Pelaez CM, Faraco EB, Farias MR, Leite SN. Avaliação da capacidade de gestão do componente especializado da assistência farmacéutica. Cien Saude Colet 2017; 22(8):2487-2499.^,3636 Garcia-Subirats I, Vargas I, Mogollón-Pérez AS, Paepe P, Silva MRF, Unger JP, Vázquez ML. Barriers in access to healthcare in countries with different health systems. A cross-sectional study in municipalities of central Colombia and north-eastern Brazil. Soc Sci Med 2014; 106:204-213.^,3737 Lima-Dellamora EC, Caetano R, Osorio-de-Castro CGS. Dispensing specialized component medicines in areas of the State of Rio de Janeiro. Cien Saude Colet 2012; 17(9):2387-2396.. Thus, a double standard of access to CEAF medications is established (among those with and those without access to appointments and tests in the private system), besides informal arrangements (such as mechanisms to overcome the queues)¹⁴14 Rover MRM, Vargas-Pelaez CM, Rocha Farias M, Nair Leite S. Acceso a medicamentos de alto precio en Brasil: la perspectiva de médicos, farmacéuticos y usuarios. Gac Sanit 2016; 30(2):110-116..

Buendgens et al.³⁸38 Buendgens FB, Blatt CR, Marasciulo ACE, Leite SN, Farias MR. Cost analysis of treatment for severe rheumatoid arthritis in a city in southern Brazil. Cad Saude Publica 2013; 29:s81-91. found that, of all users diagnosed with rheumatoid arthritis studied, only one had access to all the health services required for their treatment in the public sector. However, this study also showed that more than 70% of the financing for the treatment of the disease was provided by the public sector. Thus, even with constraints, the public sector has been responsible for most of the financing of these treatments.

This study points out that the most significant proportion of CEAF users is found where there is decentralization to the municipal level of the dispensing units (Southern and Southeastern states), which depends on the articulation capacity with the municipalities and the available resources. Limitations in this regard have already been evidenced in previous studies³⁹39 Gerlack LF, Karnikowski MGO, Areda CA, Galato D, Oliveira AG, Álvares J, Leite SN, Costa EA, Guibu IA, Soeiro OM, Costa KS, Guerra Junior AA, Acurcio FA. Gestão da assistência farmacêutica na atenção primária no Brasil. Rev Saude Publica 2017; 51(Supl. 2):15s.

40 Carvalho MN, Álvares J, Costa KS, Guerra Junior AA, Acurcio FA, Costa EA, Guibu IA, Soeiro OM, Karnikowski MGO, Leite SN. Força de trabalho na assistência farmacêutica da atenção básica do SUS, Brasil. Rev Saude Publica 2017; 51(Supl. 2):16s.^-4141 Leite SN, Manzini F, Álvares J, Guerra Junior AA, CostaEA, Acurcio FA, Guibu IA, Costa KS, Karnikowski MGO, Soeiro OM, Farias MR. Infraestrutura das farmácias da atenção básica no Sistema Único de Saúde: Análise dos dados da PNAUM-Serviços. Rev Saude Publica 2017; 51(Supl. 2):13s., which are barriers to the organization of the service network in municipalities and indicate the need for negotiations between managers⁴²42 Vargas I, Mogollón-Pérez AS, Unger J-P, da-Silva MRF, Paepe PD, Vázquez M-L. Regional-based Integrated Healthcare Network policy in Brazil: from formulation to practice. Health Policy Plan 2015; 30(6):705-717.. Problems of articulation with municipalities also appear in the non-verification of the supply of the first line of treatment, a fundamental step to ensure effective and complete treatments.

Given that, as mentioned above, access to CEAF medicines is closely related to the availability of dispensing points and access to other services for the diagnosis and monitoring of treatments¹⁴14 Rover MRM, Vargas-Pelaez CM, Rocha Farias M, Nair Leite S. Acceso a medicamentos de alto precio en Brasil: la perspectiva de médicos, farmacéuticos y usuarios. Gac Sanit 2016; 30(2):110-116., the results of this study draw attention to the growing need for coordination among health services⁴⁴44 Kuschnir R, Chorny AH. Health care networks: contextualizing the debate. Cien Amp Saude Colet 2010; 15(5):2307-2316., considering pharmaceutical care as an unequivocal part of system management and not an isolated sector¹⁵15 Rover MRM, Vargas-Pelaez CM, Farias MR, Leite SN. Da organização do sistema à fragmentação do cuidado: A percepção de usuários, médicos e farmacêuticos sobre o Componente Especializado da Assistência Farmacêutica em um estado do sul do Brasil. Physis 2016; 26(2):691-711.. The results presented here suggest that the real understanding of pharmaceutical care in the planning and decision-making process of the health system is critical to achieving equitable and timely access to treatments.

The results also show differences in the percentages invested in medicines between states. The amounts invested are mainly related to the number of users associated with the level of development and availability of health services. The Ministry of Health’s investments for group 1B purchases depend on the request for medicines in each state, which is also determined by the offer of services. However, state procurement management capacity is also a factor that influences the proportionality of investments per user. This situation is even more critical in medicines with a limited number of suppliers due to the monopolies generated by patent protection. Thus, states’ exemption expected by the current financing agreement for the highest-priced medicines⁸8 Brasil. Ministério da Saúde (MS). Da Excepcionalidade às Linhas de Cuidado: O Componente Especializado da Assistência Farmacêutica [Internet]. 1ª ed. Brasilia: MS; 2010 [acessado 2015 nov 5]. Disponível em: http://bvsms.saude.gov.br/bvs/publicacoes/excepcionalidade_linhas_cuidado_ceaf.pdf^,99 Brasil. Ministério da Saúde (MS). Portaria de Consolidação no 2 de 28 de setembro de 2017. Consolidação das normas sobre as políticas nacionais de saúde do Sistema Único de Saúde (SUS). [Internet]. [acessado 2020 maio 4]. Disponível em: https://bvsms.saude.gov.br/bvs/saudelegis/gm/2017/MatrizesConsolidacao/Matriz-2-Politicas.html
https://bvsms.saude.gov.br/bvs/saudelegi... is not adequately achieved.

Also, the states have a smaller population and, thus, lower demand (North and Northeast). They have a lower bargaining capacity vis-à-vis suppliers, which means that acquisition prices are higher; that is, the unit invests proportionally more for the same clinical condition. Thus, the states with lower socioeconomic and development indicators of the SUS will be the most burdened.

Despite the measures adopted to reduce medicine purchase prices, such as the definition of the Maximum Sale Price to the Government⁸8 Brasil. Ministério da Saúde (MS). Da Excepcionalidade às Linhas de Cuidado: O Componente Especializado da Assistência Farmacêutica [Internet]. 1ª ed. Brasilia: MS; 2010 [acessado 2015 nov 5]. Disponível em: http://bvsms.saude.gov.br/bvs/publicacoes/excepcionalidade_linhas_cuidado_ceaf.pdf, the results pointed to the need to strengthen surveillance over the drug market, implement a national price and supplier registration bank, and generate strategies for the joint purchase between states, which can contribute to price regulation¹1 Brasil. Ministério da Saúde (MS). Secretaria de Ciência, Tecnologia e Insumos Estratégicos. Departamento de Assistência Farmacêutica e Insumos Estratégicos. Assistência Farmacêutica no SUS: 20 anos de políticas e propostas para desenvolvimento e qualificação: relatório com análise e recomendações de gestores, especialistas e representantes da sociedade civil organizada [recurso eletrônico]. Brasília: MS; 2018. 125 p.: il.^,4545 Rover MRM. Avaliação da capacidade de gestão do componente especializado da assistência farmacêutica em Santa Catarina [tese]. Florianópolis: Universidade Federal de Santa Catarina; 2016.. Tobar et al.⁴⁶46 Tobar F, Drake I, Martich E. Alternativas para la adopción de políticas centradas en el acceso a medicamentos. Rev Panam Salud Publica 2012; 32(6):457-463. argue that these are alternatives for adopting policies centered on access to medicines.

The data also evidenced the focus of resources on the acquisition of medicines, to the detriment of improving other aspects relevant to achieving the goal of comprehensive care, such as continuous training of the workforce and adequate physical structure. From the participants’ perspective, the fact that CEAF’s financial transfer is exclusive for the acquisition of medicines burdens the states with the implementing costs, hindering investments in the qualification of services. On the other hand, what is established in the current regulation considers that states are responsible for implementing the CEAF⁹9 Brasil. Ministério da Saúde (MS). Portaria de Consolidação no 2 de 28 de setembro de 2017. Consolidação das normas sobre as políticas nacionais de saúde do Sistema Único de Saúde (SUS). [Internet]. [acessado 2020 maio 4]. Disponível em: https://bvsms.saude.gov.br/bvs/saudelegis/gm/2017/MatrizesConsolidacao/Matriz-2-Politicas.html
https://bvsms.saude.gov.br/bvs/saudelegi... .

Another aspect reported by managers was the additional cost of financing drugs not covered by the CEAF but provided as a result of lawsuits. The fact that the medicines requested through the courts, suggested for incorporation by the participants, have already been evaluated by the National Commission for the Incorporation of Technologies in the SUS and the opinion of the majority was unfavorable⁴⁷47 Brasil. Ministério da Saúde (MS). Portaria no 34, de 6 de agosto de 2013. Torna pública a decisão de não incorporar o medicamento brometo de tiotrópio para o tratamento da doença pulmonar obstrutiva crônica no Sistema Único de Saúde (SUS). Brasília: MS; 2013. [acessado 2020 abr 25]. Disponível em: http://bvsms.saude.gov.br/bvs/saudelegis/sctie/2013/prt0036_06_08_2013.html

48 Brasil. Ministério da Saúde (MS). Secretaria de Ciência, Tecnologia e Insumos Estratégicos Departamento de Gestão e Incorporação de Tecnologias em Saúde Coordenação de Avaliação e Monitoramento de Tecnologias. Relatório de Recomendação: Insulinas análogas de ação prolongada para o tratamento de diabetes mellitus tipo II. Brasília: MS; 2018. [acessado 2020 abr 25]. Disponível em: http://conitec.gov.br/images/Consultas/Relatorios/2018/Relatorio_InsulinasAnalogas_AcaoProlongada_DM2_CP80_2018.pdf^-4949 Brasil. Ministério da Saúde (MS). Secretaria de Ciência, Tecnologia e Insumos Estratégicos. Relatório de Recomendação: Ranibizumabe para Degeneração Macular Relacionada à Idade. Brasília: MS; 2015. [acessado 2020 abr 25]. Disponível em: http://conitec.gov.br/images/Relatorios/2015/Relatorio_Ranibizumabe_DMRI_final.pdf, corroborates the evidence collected on the use of judicialization as a mechanism of the pharmaceutical industry to pressure the inclusion of new technologies in the SUS⁴4 Vargas-Peláez CM, Rover MRM, Leite SN, Rossi Buenaventura F, Farias MR. Right to health, essential medicines, and lawsuits for access to medicines - A scoping study. Soc Sci Med 2014; 121:48-55.^,5050 Figueiredo TA, Pepe VLE, Osorio-de-Castro CGS. A sanitary focus on medicines lawsuit. Physis 2010; 20(1):101-118.. Given this situation, there is a need to develop joint strategies between the Ministry of Health and the states aimed at disseminating independent information on the efficacy and safety of medications and training prescribers for RUM.

The focus on the medicine product is also observed in the development of CEAF-related activities since activities for the availability of medicines are prioritized. In contrast, the implementation of clinical-assistance activities required for monitoring the treatments (e.g., implementation of RC and monitoring according to the PCDT) are still limited, already reported by other studies¹1 Brasil. Ministério da Saúde (MS). Secretaria de Ciência, Tecnologia e Insumos Estratégicos. Departamento de Assistência Farmacêutica e Insumos Estratégicos. Assistência Farmacêutica no SUS: 20 anos de políticas e propostas para desenvolvimento e qualificação: relatório com análise e recomendações de gestores, especialistas e representantes da sociedade civil organizada [recurso eletrônico]. Brasília: MS; 2018. 125 p.: il.^,1616 Rover MRM, Vargas-Pelaez CM, Faraco EB, Farias MR, Leite SN. Avaliação da capacidade de gestão do componente especializado da assistência farmacéutica. Cien Saude Colet 2017; 22(8):2487-2499.^,3737 Lima-Dellamora EC, Caetano R, Osorio-de-Castro CGS. Dispensing specialized component medicines in areas of the State of Rio de Janeiro. Cien Saude Colet 2012; 17(9):2387-2396.^,5151 Programa de Apoio às Secretarias Estaduais de Saúde (Pases) - Projeto (Proadi-SUS): Cuidado Farmacêutico no Componente Especializado da Assistência Farmacêutica. [acessado 2020 abr 25]. Disponível em: http://www.conass.org.br/programa-de-apoio-as-secretarias-estaduais-de-saude/
http://www.conass.org.br/programa-de-apo... . Thus, the lack of data on treatment results translates into the unavailability of information regarding improved people’s health status and an effective Component, which is a weakness in health services⁵²52 García-Altés A, Zonco L, Borrell C, Plasència A. Measuring the performance of health care services: a review of international experiences and their application to urban contexts. Gac Sanit 2006; 20(4):316-324..

Finally, the logistical problems mentioned and the lack of interconnected computerized systems can lead to shortages or delays in the availability of medicines. Specifically concerning information systems, it is essential to highlight that financial and medicine transfers only occur after data transfer to the Ministry of Health. Failures and problems that may occur in this transfer and the impossibility of states requesting technical reserves to serve new users can lead to lack or delays in care, with negative individual and group impacts due to deteriorated health status, use of additional therapies, and services, and higher expenses on treatments⁵³53 Arrais PSD, Brito LL, Barreto ML, Coelho HLL. Prevalência e fatores determinantes do consumo de medicamentos no Município de Fortaleza, Ceará, Brasil. Cad Saude Publica 2005; 21(6):1737-1746.^,5454 Fritzen JS, Motter FR, Paniz VMV. Acesso regular e adesão a medicamentos do componente especializado assistência farmacêutica. Rev Saude Publica 2017; 51:109.. Interconnected systems provide agility in transferring information, allowing timely service to users, and deserve special attention from the states and the Ministry of Health.

It should be noted that part of the purchase of medicines demanded by the study participants for the Ministry of Health’s acquisition has been centralized in recent years. More recently, through Ordinance No. 13 of January 2020, the Ministry of Health partially solved the issue of short periods for renewal of requests by allowing them to be performed for up to six months of treatment⁵⁵55 Brasil. Ministério da Saúde (MS). Portaria nº 13, de 6 de janeiro de 2020. Altera o Título IV do Anexo XXVIII da Portaria de Consolidação nº 2/GM/MS, de 28 de setembro de 2017, que dispõe sobre as regras de financiamento e execução do Componente Especializado da Assistência Farmacêutica no âmbito do Sistema Único de Saúde (SUS). Brasília: MS; 2020. [acessado 2020 abr 25]. Disponível em: http://www.in.gov.br/web/dou/-/portaria-n-13-de-6-de-janeiro-de-2020-237059261.. This measure reduces bureaucracy¹1 Brasil. Ministério da Saúde (MS). Secretaria de Ciência, Tecnologia e Insumos Estratégicos. Departamento de Assistência Farmacêutica e Insumos Estratégicos. Assistência Farmacêutica no SUS: 20 anos de políticas e propostas para desenvolvimento e qualificação: relatório com análise e recomendações de gestores, especialistas e representantes da sociedade civil organizada [recurso eletrônico]. Brasília: MS; 2018. 125 p.: il., but if not correctly implemented, it can cause losses for patients whose diseases require more frequent follow-up (e.g., chronic kidney disease patients, transplant recipients, and patients with active inflammatory diseases).

One limitation of this study is the use of some data mentioned by the informants, as the states do not have or do not make publicly available all the data related to the organization and management of the Component. Intentional sampling was adopted, and, therefore, the study cannot be interpreted as an evaluation of the four regions as a whole. However, the results provide an overview of the different conditions of Brazilian states and the different conditions of access to CEAF medicines.

This first approach to the study of the organization of CEAF points out that the Component has contributed to the expanded access to high-priced medicines in Brazil. However, given that access to medicines depends on contextual characteristics and management capacity, the results of this study highlight the need to overcome interstate inequalities in the access to health services to meet the constitutional precepts of universal and comprehensive care.

The results suggest that the country needs to advance in access to drug therapy, ensuring equity and opportunity. Overcoming these challenges requires measures related to the Component’s management and more significant interaction between pharmaceutical care managers and the other managers of the SUS to design strategies to strengthen the decentralization process and overcome the shortcomings in the provision of specialized services.

We also observed that the different forms of organization and structuring of CEAF have impacted people’s access to medicines. The finding that the states with the worst development indicators invest proportionally more for the same clinical condition is troubling. Finally, the lack of national data on CEAF points to the need for more in-depth studies on the results achieved, which enable the formulation of public policies to streamline the implementation of the CEAF.

Acknowledgments

This study was partially financed by the Coordenação de Aperfeiçoamento de Pessoal de Nível Superior - Brazil (CAPES) - Financial Code 001.

References

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