Abstract

The aim of this study is to evaluate the management capacity of the Specialized Component of Pharmaceutical Services (CEAF, in Portuguese) in the state of São Paulo (SP), according to the organizational, operational and sustainability aspects. The study was designed as an evaluative investigation, with the adoption of a theoretical model and protocol of indicators developed for application at the national level and validated (Nominal Group and Traditional Committee) for application in the reality of the SP. The data collection in the 35 CEAF units was carried out in 2017 and 2018, and covered all technical areas that participate in the management/execution of CEAF, in both its central and regional scopes. The assessment of management capacity was based on a critical analysis of the obtained results, analyzing their strengths and weaknesses. After collecting data from 35 CEAF units, it was found that the management capacity was positive in the operational dimension with challenges concentrated in the other dimensions. The results showed greater investments and development in the technical aspects of pharmaceutical services, but deficiencies in such areas as the monitoring of clinical results, infrastructure, regulation, and communication with the actors involved.

Key words:
Health Services Research; Population Health Management; Pharmaceutical Services; High-cost drugs

Introduction

In Brazil, access to high-cost medicine depends on actions and connections which involve the three levels of government. From the three components of pharmaceutical care - which are, Basic Component of Pharmaceutical Care (BCPC), Strategic (StCPA) and Specialized (CEAF) - the CEAF is that which covers high-cost medicine provided by the Brazilian Unified Health System (SUS, in Portuguese). It is defined as a strategy of access to medicine which guarantees treatment integrality, with its care lines defined in Clinical Protocols and Therapeutic Guidelines. At its level, what can be most commomly verified is the tension among increases in spending, pressures of demand, and commercial competition in terms of medicine¹1 Brasil. Ministério da Saúde (MS). Portaria de Consolidação n° 2, de 28 de setembro de 2017: Consolidação das normas sobre as políticas nacionais de saúde do Sistema Único de Saúde. Brasília: MS; 2017. [acessado 2018 fev 5]. Disponível em: http://bvsms.saude.gov.br/bvs/saudelegis/gm/2017/prc0002_03_10_2017.html

2 Brasil. Ministério da Saúde (MS). Da excepcionalidade às linhas de cuidado: o Componente Especializado da Assistência Farmacêutica. Brasília: MS; 2010.^-33 Brasil. Conselho Nacional de Secretários de Saúde (CONASS). Assistência farmacêutica no SUS: para entender a gestão do SUS. Brasília: CONASS; 2011..

The acquisition of medicine represents an important part of the total expenses with health care, and availability of high-cost medicine has great social impact and therapeutic relevance; moreover, this kind of medicine requires specialized services in order to be effective³3 Brasil. Conselho Nacional de Secretários de Saúde (CONASS). Assistência farmacêutica no SUS: para entender a gestão do SUS. Brasília: CONASS; 2011.

4 São Paulo (Estado). Secretaria da Saúde, Conselho de Secretários Municipais de Saúde (COSEMS) - São Paulo. Assistência farmacêutica no SUS: SUS no Estado de São Paulo: atualização para gestores municipais. São Paulo: SES/SP e COSEMS/SP; 2013.^-55 Machline C. A Assistência à Saúde no Brasil. In: Storpirtis S, Mori ALPM, Yochiy A, Ribeiro E, Porta V. Farmácia Clínica e Atenção Farmacêutica. Rio de Janeiro: Guanabara-Koogan; 2008..

Although there is a clear emphasis in Brazilian literature and among the managers concerning the financial aspects of CEAF, there are several challenges that constitute a complex context for its management in order to provide full and universal access to medicine³3 Brasil. Conselho Nacional de Secretários de Saúde (CONASS). Assistência farmacêutica no SUS: para entender a gestão do SUS. Brasília: CONASS; 2011.^,66 Rover MRM, Vargas-Peláez CM, Faraco EB, Farias MR, Leite SN. Avaliação da capacidade de gestão do componente especializado da assistência farmacêutica. Cien Saude Colet 2017; 22(8):2487-2499.. One of the challenges is the decentralization of actions, in the sense that states and municipalities take over direct responsibility for health care, including the actions related to pharmaceutical care⁶6 Rover MRM, Vargas-Peláez CM, Faraco EB, Farias MR, Leite SN. Avaliação da capacidade de gestão do componente especializado da assistência farmacêutica. Cien Saude Colet 2017; 22(8):2487-2499..

The management of CEAF imposes important challenges in terms of providing for user needs, in terms of the other health services, as well as in terms of infrastructure and the process of services³3 Brasil. Conselho Nacional de Secretários de Saúde (CONASS). Assistência farmacêutica no SUS: para entender a gestão do SUS. Brasília: CONASS; 2011.^,44 São Paulo (Estado). Secretaria da Saúde, Conselho de Secretários Municipais de Saúde (COSEMS) - São Paulo. Assistência farmacêutica no SUS: SUS no Estado de São Paulo: atualização para gestores municipais. São Paulo: SES/SP e COSEMS/SP; 2013.^,66 Rover MRM, Vargas-Peláez CM, Faraco EB, Farias MR, Leite SN. Avaliação da capacidade de gestão do componente especializado da assistência farmacêutica. Cien Saude Colet 2017; 22(8):2487-2499. . To overcome these challenges, the investigation of health policies and services plays a key role, allowing for the identification of relevant issues and the provision of reliable information, thus becoming an important tool to guide management and to improve the quality of the services rendered⁷7 Lugones R, Bermudez JAZ, Bonfim JRA. Analisis comparado de política de medicamentos. São Paulo: Hucitec/Sobravime; 1999..

In the area of pharmaceutical care, expanded management suggestions and assessments were presented by Barreto⁸8 Barreto JL. Análise da gestão descentralizada da assistência farmacêutica: um estudo em municípios baianos [dissertação]. Salvador: Universidade Federal da Bahia; 2007. and Barreto and by Guimarães⁹9 Barreto JL, Guimarães MCL. Evaluation of decentralized management of basic pharmaceutical care in Bahia State, Brazil. Cad Saude Publica 2010; 26(6):1207-1220.. Based on the reference by Carlos Matus¹⁰10 Matus C. Política, planejamento e governo. Brasília: Instituto de Pesquisa Econômica Aplicada; 1993. and Guimarães et al.¹¹11 Guimaraes MCL, Santos SMC, Melo C, Sanches Filho A. Avaliação da capacidade de gestão de organizações sociais: uma proposta metodológica em desenvolvimento. Cad Saude Publica 2004; 20(6):1642-1650., they argue that management is a technical, political, and social process capable of producing results, and that management capability is the capability of an organization, to decide, with autonomy, flexibility and transparence, mobilizing resources and building sustainability of the results of management¹¹11 Guimaraes MCL, Santos SMC, Melo C, Sanches Filho A. Avaliação da capacidade de gestão de organizações sociais: uma proposta metodológica em desenvolvimento. Cad Saude Publica 2004; 20(6):1642-1650. (p. 1646). Considering such concepts, assessments of the management capability of pharmaceutical care were developed at the municipal and state levels in a broad perspective, beyond structures and technical processes⁶6 Rover MRM, Vargas-Peláez CM, Faraco EB, Farias MR, Leite SN. Avaliação da capacidade de gestão do componente especializado da assistência farmacêutica. Cien Saude Colet 2017; 22(8):2487-2499.^,88 Barreto JL. Análise da gestão descentralizada da assistência farmacêutica: um estudo em municípios baianos [dissertação]. Salvador: Universidade Federal da Bahia; 2007.^,1212 Mendes SJ, Leite SN. Resultados gerais da avaliação da gestão da assistência farmacêutica em Santa Catarina. In: LEITE SN, Farias MR, Manzini F, Mendes SJ, Rover MRM. Gestão da Assistência Farmacêutica: Proposta para Avaliação no Contexto Municipal: A Experiência em Santa Catarina. Florianópolis: Editora da UFSC; 2015. p. 147-164..

Based on these references, management capability is assessed through three independent dimensions: organizational, operational, and sustainability. The operational dimension shows the ability of maintaining and expanding the logistic and managerial resources. The sustainability dimension reveals the ability of supporting the management results, considering aspects related to the institutionalization of systems and strategies which can expand and/or consolidate support and alliances capable of favoring sustainability in decisions and results planned by the management⁹9 Barreto JL, Guimarães MCL. Evaluation of decentralized management of basic pharmaceutical care in Bahia State, Brazil. Cad Saude Publica 2010; 26(6):1207-1220..

The state of São Paulo, which has 21% of the Brazilian population, also faces challenges in the management of pharmaceutical care¹³13 São Paulo (Estado). Secretaria da Saúde. Diagnóstico PES 2020-2023 [acessado 2020 abr 20]. Disponível em: http://www.cosemssp.org.br/wp-content/uploads/2020/01/PLANO-ESTADUAL-DE-SAUDE-2020-2023.pdf
http://www.cosemssp.org.br/wp-content/up... . This is one of the areas with the most financial impact for CEAF, with projections of increasing even further¹³13 São Paulo (Estado). Secretaria da Saúde. Diagnóstico PES 2020-2023 [acessado 2020 abr 20]. Disponível em: http://www.cosemssp.org.br/wp-content/uploads/2020/01/PLANO-ESTADUAL-DE-SAUDE-2020-2023.pdf
http://www.cosemssp.org.br/wp-content/up... _. In 2015, the investment in medicine by CEAF exceeded R$1.5 billion, of which R$ 150 million were financed by the state¹⁴14 São Paulo (Estado). Secretaria da Saúde. Relatório de Gestão: 3º quadrimestre de 2015. São Paulo: SES/SP; 2015.

15 São Paulo (Estado). Secretaria de Planejamento e Desenvolvimento Regional. Orçamento do Estado 2015: Orçamentos Fiscal, da Seguridade Social e de Investimentos das Empresas. São Paulo: SES/SP; 2015.^-1616 Martins KOF. Componente Especializado da Assistência Farmacêutica. Apresentação realizada no Grupo Técnico de Assistência Farmacêutica da Comissão Intergestores Bipartite. São Paulo: SES/SP; 2015.. 

In this context, it is increasingly more important to make progress in management in order to overcome adversities and respond properly to the needs of the population. Moreover, it is important to remember that the development of assessment studies about the CEAF is quite recent⁶6 Rover MRM, Vargas-Peláez CM, Faraco EB, Farias MR, Leite SN. Avaliação da capacidade de gestão do componente especializado da assistência farmacêutica. Cien Saude Colet 2017; 22(8):2487-2499..

Therefore, this study aimed to assess the management ability of the CEAF in São Paulo, seeking subsidies to qualify pharmaceutical care and expanding the data on accessibility of high-cost medicine.

Methodology

This is an evaluation study, which took place from June 2016 to February 2018. Both a logical and a theoretical model were used, as well as the indicator protocol and the forms for data collection developed by Rover et al.⁶6 Rover MRM, Vargas-Peláez CM, Faraco EB, Farias MR, Leite SN. Avaliação da capacidade de gestão do componente especializado da assistência farmacêutica. Cien Saude Colet 2017; 22(8):2487-2499.^,1718, after adaptation. The indicator protocol is made up of 8 organizational (80 points), 11 operational (110 points), and 6 sustainability (60 points) indicators ⁶6 Rover MRM, Vargas-Peláez CM, Faraco EB, Farias MR, Leite SN. Avaliação da capacidade de gestão do componente especializado da assistência farmacêutica. Cien Saude Colet 2017; 22(8):2487-2499.^,1818 Rover MRM, Vargas-Peláez CM, Farias MR, Leite SN. Metodologia para o desenvolvimento de um protocolo de indicadores para a avaliação da capacidade de gestão da assistência farmacêutica. UFSC - Especialização em Gestão da Assistência Farmacêutica. Universidade Aberta do SUS (UNASUS). [acessado 2017 jan 5]. Disponível em: https://ares.unasus.gov.br/acervo/handle/ARES/6141
https://ares.unasus.gov.br/acervo/handle... .

Place of study and subjects of the survey

This project was developed at the Health Secretariat of the State of São Paulo (SES/SP, in Portuguese), at its central level (CEAF directors) and at its regional level (Central Warehouse and Specialized Medicine Pharmacies [FME, in Portuguese]).

The subjects of the survey (hereinafter referred to as the ‘team of specialists’), were selected by convenience, for each phase, according to the following criteria:

Validation of the theoretical model and indicator protocol: professionals with deep knowledge and experience with pharmaceutical care from the state of São Paulo, involved in research, teaching, management, and/or care, with direct or indirect involvement with CEAF; availability to participate in the two phases of the study: validation of online tools and participation in the consensus workshop (in-house).

Appearance validation of the data collection forms and in the phase of their use: professionals responsible (or co-responsible) for the FME and for the Central Warehouse of the SES/SP and manager (central level) of the Components of Pharmaceutical Care and of the CEAF from the SES/SP; availability of response of the data collection form.

Figure 1 shows, for each phase of the survey, the quantity and involvement of the subjects described above.

Adaptation of the survey tools

Adaptation and validation of the theoretical model and the indicator protocol

It was necessary to adapt the theoretical model and indicator protocol, developed by Rover et al.⁶6 Rover MRM, Vargas-Peláez CM, Faraco EB, Farias MR, Leite SN. Avaliação da capacidade de gestão do componente especializado da assistência farmacêutica. Cien Saude Colet 2017; 22(8):2487-2499.^,1818 Rover MRM, Vargas-Peláez CM, Farias MR, Leite SN. Metodologia para o desenvolvimento de um protocolo de indicadores para a avaliação da capacidade de gestão da assistência farmacêutica. UFSC - Especialização em Gestão da Assistência Farmacêutica. Universidade Aberta do SUS (UNASUS). [acessado 2017 jan 5]. Disponível em: https://ares.unasus.gov.br/acervo/handle/ARES/6141
https://ares.unasus.gov.br/acervo/handle... , considering the functional variables of the CEAF in the state of São Paulo. The adaptation of the indicator protocol took into consideration that the indicator is only valid in the specific context in which the evaluation is performed¹⁹19 Santos SMC, Guimarães MCL, Melo CMM, Sanches Filho A. Subsídios para avaliação da gestão pública: processo de construção de indicadores para avaliação da capacidade de gestão de organizações sociais. O&S 2006; 13(37):109-124.. The indicators were adapted according to their question, measure, punctuation, parameters, source of data, and weight.

For content validation, the following techniques were used: Nominal Group Technique (NGT) and Traditional Committee. The following phases were followed:

Phase I - NGT - online phase:

The specialists received the theoretical model and the adapted indicators, as well as the theoretical foundation, which led to its elaboration. The documents were organized in forms and made available through an online address, counting on the support of the Google® - Google Forms app and exported to the Microsoft Excel® software for the analyses. The created forms were divided into four parts. The 1^st form represented the adapted theoretical model analysis, according to its “relevance”²⁰20 Pringle M, Wilson T, Grol R. Measuring "goodness" in individuals and healthcare systems. BMJ 2002; 325:704-707.. In the 2^nd, 3^rd, and 4^th forms, the specialists evaluated the quality of the adapted indicators in relation to their question, measure, parameter, data source, and punctuation, using the following attributes: Clarity; Validity/Effectiveness; Accessibility/Measurability²⁰20 Pringle M, Wilson T, Grol R. Measuring "goodness" in individuals and healthcare systems. BMJ 2002; 325:704-707.^,2121 Rede Interagencial de Informação para a Saúde (RIPSA). Indicadores básicos para a saúde no Brasil: conceitos e aplicações. 2ª ed. Brasília: Organização Pan-Americana da Saúde; 2008 [acessado 2017 jan 17]. Disponível em: http://tabnet.datasus.gov.br/tabdata/livroidb/2ed/indicadores.pdf.. For punctuation, a 5-point Likert scale was used²²22 Vieira KM, Dalmoro M. Dilemas na Construção de Escalas Tipo Likert: o Número de Itens e a Disposição Influenciam nos Resultados? Revista Gest@o.Org 2013; 6(3):161-174.. In addition, open fields were included, for justification (when the score given by the specialist was below 3 points) and for improvement answers (regardless of the score given).

Once the data was tabulated, the average of points given was calculated, considering as approved those which received 4 or more points. The indicators which, on average, had a score of 3.9 or below, in any of the attributes, were chosen for discussion at the consensus workshop (phase II).

The suggestions for improvement proposed by the specialists to improve the theoretical model and indicators, regardless of the average score, were evaluated and, whenever relevant, were accepted and incorporated.

Those that had a significant impact on the model or indicator, regardless of having been approved in Phase I, were brought for discussion in Phase II.

Phase II - Traditional Committee Technique:

An in-house, 8-hour workshop was held, according to the “Traditional Committee” consensus technique. First, the theoretical concepts which are the foundation of the indicator²³23 Rover MRM, Vargas-Peláez CM, Faraco EB, Mendes SJ, Manzini F, Soares L, Storpirtis S, Farias MR, Leite SN. Da construção à aplicação: indicadores para a avaliação da gestão da assistência farmacêutica - a experiência em Santa Catarina. Florianópolis: Escola Nacional dos Farmacêuticos; 2017. protocol, were reviewed. Second, the indicators which had scores of 3.9 and below were presented, as were those that were approved but received suggestions for improvement which impacted their content. The specialists discussed the questions presented until they reached a consensus on keeping (with or without adjustments) or on excluding the indicators. In the third moment, the parameters and weights of all the indicators were reanalyzed, and adjustments and adaptations were made.

After all the adjustments had been implemented, the specialists received the validated versions.

Adaptation and apparent validation of the data collection tools

The initial adaptation of the data collection tools was performed by the author (first author) of this research, based on the documents validated in the previous phase.

The adapted tools are: (a) Data collection form with the MANAGER (central level); (b) Data collection form with PHARMACIES (regional level); (c) Data collection form with the SES/SP CENTRAL WAREHOUSE. The tool (a) was produced using Microsoft Word® software, and tools (b) and (c) were organized in forms with Google® - Google Forms.

After adaptation, the tools were presented to the CEAF - SES/SP management team, who validated the content by consensus and issued the permission for the start of the apparent validation (layout and form comprehension) and for data collection afterwards.

The author and the CEAF - SES/SP management team defined that the apparent validation of the data collection tools would be done with:

The CEAF manager (central level) - advisor responsible for CEAF;

The responsible pharmacists from three specialized medicine pharmacies (FME) - one in the state capital and of large size (management by Social Health Organization); one in the metropolitan area of the state capital, of smaller size (indirect management); and another from the countryside, of large size (management by Social Health Organization);

The pharmacist responsible for the Central Warehouse.

This phase was the last phase of the traditional Committee.

Use of the data collection tools

Data collection was conducted from December/2017 to January/2018 and covered every area which participates in the management/execution of CEAF, connected to SES/SP, at central level (CEAF direction) and regional level (Central Warehouse and 37 FME).

The data collection form for the MANAGER was sent via e-mail, and the data collection forms for the PHARMACIES and CENTRAL WAREHOUSE were made available at an Internet site, with the support of Google® - Google Forms app.

Assessment of the CEAF management capability in the State of São Paulo

With the information collected, it was possible to fill in the validated indicator protocol (Chart 1). The assessment of the CEAF management capability in the state of São Paulo was based on a critical analysis of the results, looking into the strengths and weaknesses of the development of CEAF’s state level management.

The attribution of a value judgement for each dimension was based on the parameters validated by the team of specialists and was converted into a color scheme, which helped visualize the obtained results, as presented in Chart 2 ²³23 Rover MRM, Vargas-Peláez CM, Faraco EB, Mendes SJ, Manzini F, Soares L, Storpirtis S, Farias MR, Leite SN. Da construção à aplicação: indicadores para a avaliação da gestão da assistência farmacêutica - a experiência em Santa Catarina. Florianópolis: Escola Nacional dos Farmacêuticos; 2017..

The survey was approved by the Research Ethics Committee from School of Pharmaceutical Sciences at the University of São Paulo (CEP/FCF/USP, in Portuguese), logged under Decision number 1,744,740, on September 26, 2016.

Results

The theoretical model, adapted and validated for the context of the state of São Paulo, is presented in Figure 2.

The indicator protocol validated for the state of São Paulo had few changes in comparison to the protocol used as a reference. The most significant adaptations were made in the measurements so that they could better represent the reality of the state of São Paulo.

The adjustments in the measurements were categorized as “temporality” - to limit a measurement within a given time frame; “question writing” - adjustments in the writing of the question on measurement, aimed at providing more clarity and understanding of what is being measured and/or semantic adjustments; “parameter” - altering, expanding, or reducing the parameters used to attribute points to the measurement; “measurement” - adjustments or alterations of the measurement of the indicators; “data collection” - alteration, expansion, or reduction of the sources of data collection to be consulted for the application of the measurement. There was also a repositioning of a measurement of the indicator “Financing” into the indicator “Programing/Acquisition of Medicine”, given the understanding that the practice of tax exemption or the application of the coefficient of price adjustment mostly impacts the capacity to acquire the medicine with a discount, than effectively in the capacity to guarantee the financing for CEAF.

Of all the adjustments done in the indicator protocol, 84 were performed in the operational dimension, 28 in the organizational dimension, and 25 in the sustainability dimension. The most frequent kind of adjustment was Adjustment in writing to achieve more clarity and objectivity²⁴24 Fatel KO. Avaliação da capacidade de gestão do Componente Especializado da Assistência Farmacêutica no Estado de São Paulo [dissertação]. São Paulo: Universidade de São Paulo; 2018. [acessado 2020 out 25]. Disponível em: https://teses.usp.br/teses/disponiveis/9/9139/tde-03102018-162240/publico/Karina_de_Oliveira_Fatel_Martins_ME_Original.pdf.

The number of FME represented in the data collection according to the Regional Health Department (RHD) is presented in Figure 3.

Only four of the 37 FME did not send the data; therefore, the collection included a final sample of 35 units (33 FME, 1 from the CEAF Directory, 1 from the Central Warehouse). The results of the evaluation by indicator and dimension are presented in Chart 1. The situation found in the evaluated dimensions differs in many aspects. The dimension which had the lowest score was sustainability, with emphasis on the indicators of social control, relation between services, and clinical aspects being the most critical. In that dimension the indicators with the best scores were the manager’s profile and accessibility. In the organizational dimension, participation and decentralized access had the best performance, while the monitoring of the actions and regulation appeared as factors which needed the most attention.

Finally, in the dimension which presented the best evaluation, the operational dimension, the main strengths were those related to best logistic practices, financing, and programing/acquisition. The main weaknesses were in normative conditions and infrastructure; therefore, deficiencies were found in both the legal and sanitary conditions, which hampered activities of medicine distribution by CEAF.

Discussion

This study enabled us to evaluate the management capacity of CEAF in the state of São Paulo. The adaptations done in the protocol developed by Rover et al.⁶6 Rover MRM, Vargas-Peláez CM, Faraco EB, Farias MR, Leite SN. Avaliação da capacidade de gestão do componente especializado da assistência farmacêutica. Cien Saude Colet 2017; 22(8):2487-2499. considered the weighted definitions in the literature¹¹11 Guimaraes MCL, Santos SMC, Melo C, Sanches Filho A. Avaliação da capacidade de gestão de organizações sociais: uma proposta metodológica em desenvolvimento. Cad Saude Publica 2004; 20(6):1642-1650.^,2727 Manzini F, Farias MR, Elaboração e aplicação do modelo de avaliação da capacidade de gestão da assistência farmacêutica nos municípios catarinenses. In: Leite SN, Farias MR, Manzini F, Mendes SJ, Rover MRM. Gestão da Assistência Farmacêutica: Proposta para Avaliação no Contexto Municipal: A Experiência em Santa Catarina. Florianópolis: Editora da UFSC; 2015. p. 71-94., concerning the importance of the adaptation of the indicators in a participative manner so that they would reflect the local context. In addition to the adaptation to the reality of the state of São Paulo, the consensus workshops made contributions to pharmaceutical care, thanks to the discussions that took place in the process of this study, bringing together the professionals in this sector.

The evaluation demonstrated that issues related to the operational dimension, in other words, process and technical operations, are much more developed and structured. This result, already verified in other studies⁶6 Rover MRM, Vargas-Peláez CM, Faraco EB, Farias MR, Leite SN. Avaliação da capacidade de gestão do componente especializado da assistência farmacêutica. Cien Saude Colet 2017; 22(8):2487-2499.^,99 Barreto JL, Guimarães MCL. Evaluation of decentralized management of basic pharmaceutical care in Bahia State, Brazil. Cad Saude Publica 2010; 26(6):1207-1220.^,1212 Mendes SJ, Leite SN. Resultados gerais da avaliação da gestão da assistência farmacêutica em Santa Catarina. In: LEITE SN, Farias MR, Manzini F, Mendes SJ, Rover MRM. Gestão da Assistência Farmacêutica: Proposta para Avaliação no Contexto Municipal: A Experiência em Santa Catarina. Florianópolis: Editora da UFSC; 2015. p. 147-164., demonstrates the strong technical development of pharmaceutical care in recent decades. From the beginning of the 2000s, the decentralization of actions and financing of pharmaceutical care demanded theoretical-methodological definitions and the development of services at the health secretariats²⁸28 Marin N. Assistência Farmacêutica para gerentes municipais. Rio de Janeiro: Opas/OMS; 2003.. Therefore, operational aspects, like financing, programing/acquisition, and best practices in logistics, were evaluated as “fair”. These are aspects considerably regulated and defined nationally for states and municipalities (according to each element of the federation), and are therefore more objective in the sense that there are well-established procedures and rules for their execution. We should emphasize the importance of the state level management to maintain and improve those indicators, which are essential for the quality of the medicine, and particularly, to guarantee the safety and the access of the patients²⁹29 Pinto VB. Armazenamento e distribuição: o medicamento também merece cuidados. OPAS/OMS 2016; 1(12):1-7..

In terms of financing, the positive results are related to annual budget planning and to financial availability capable of supplying the acquisition needs. Other outstanding points were the refused purchases (below 0.3%) and the monitoring of national fund transfers. However, the state manager indicated that judicial and administrative litigation resulted in the relocation of resources and compromised the balance, with risk of affecting financial availability. According to Medeiros³⁰30 Medeiros AL. Assistência farmacêutica no SUS: responsabilidade compartilhada por União, Estados e Municípios. São Paulo/SP [tese]. Faculdade de Saúde Pública da Universidade de São Paulo; 2018., from the total amount spent with health in the state of São Paulo, 9.86% was used in the acquisition of medicine, and the annual budget laws provided resources for the acquisition, production, and distribution of medicine.

Considering that medicine programming is fundamental in order to guarantee availability in large amounts and in an adequate time frame, corresponding to the needs of the users, and avoiding wasting (p. 14), it is important that the SES/SP maintain and improve the methods in use³¹31 Brasil. Ministério Público Federal. Procuradoria Federal dos Direitos do Cidadão. Guia de referência para o Ministério Público Federal: assistência farmacêutica. Brasília: MPF; 2017. [acessado 2018 jan 20]. Disponível em: http://www.mpf.mp.br/atuacao-tematica/pfdc/midiateca/nossas-publicacoes/guia-para-o-mpf-assistencia-farmaceutica-2017. Concerning the acquisition of medicine, the SES/SP, as well as the Health Secretariat of the state of Santa Catarina⁶6 Rover MRM, Vargas-Peláez CM, Faraco EB, Farias MR, Leite SN. Avaliação da capacidade de gestão do componente especializado da assistência farmacêutica. Cien Saude Colet 2017; 22(8):2487-2499., have been able to achieve favorable proposals for public administration by applying the Price Adjustment Coefficient (PAC) and tax exemptions to the purchasing of CEAF medicine. Moreover, formal and informal strategies were used to deal with problems related to the process of acquisition, for example, price registration.

Although SES/SP does formalize the billing of medicine (for instance, atorvastatin, fenoterol and cyclosporine) which are part of Group 2 of CEAF, showing its involvement in the financing of the component and respecting the lines of care established by the Clinical Protocols and Therapeutic Directives (PCDT, in Portuguese), there is still a need to improve its execution capacity in terms of complementarity, since to date, there is no agreement on a basic list of medicine between the municipal administrations at the CIB (Bi-party Management Commission) to address the first-line care (Group 3). This indicator is also related to identified weaknesses in communication with the municipalities. The organization of pharmaceutical care, by components, with distinctive rules and financing, increases the challenges for the managers in terms of achieving integral access to medicine. Therefore, it is extremely important to search for strategies which can lead to this integrality, following the example of the state of Santa Catarina, where there is a basic list of Group 3 medicine agreed upon with CIB⁶6 Rover MRM, Vargas-Peláez CM, Faraco EB, Farias MR, Leite SN. Avaliação da capacidade de gestão do componente especializado da assistência farmacêutica. Cien Saude Colet 2017; 22(8):2487-2499.^,3232 Rover MRM. Avaliação da capacidade de gestão do Componente Especializado da Assistência Farmacêutica em Santa Catarina [tese]. Universidade Federal de Santa Catarina, Centro de Ciências da Saúde, Programa de Pós-Graduação em Farmácia. Florianópolis: UFSC; 2016..

In this realm, two indicators - normative conditions and infrastructure - did not reach the defined parameters, requiring priority attention by management. Although there has been investment in the infrastructure of pharmacies, in the informalization of the network from 2013 to 2016, and in the development of initiatives to expand the storage capability of the SES Central Warehouse³⁰30 Medeiros AL. Assistência farmacêutica no SUS: responsabilidade compartilhada por União, Estados e Municípios. São Paulo/SP [tese]. Faculdade de Saúde Pública da Universidade de São Paulo; 2018., the data obtained show the need to invest more in units which distribute medicine. The adaptation of the infrastructure in compliance with sanitary norms seeks to improve the quality of the services, ensuring medicine quality and safety for the patients. It is important to highlight that both the direct and the indirect management units (by OSS - Social Health Organization) - showed infrastructural weaknesses. Hence, even though the units managed by OSS receive financing for investment in their units, the infrastructure difficulties call attention to the growing need for the evaluation of public-private contracts³³33 Soares GB, Borges FT, Santos RR, Garbin CAS, Moimaz SAS, Siqueira CEG. Organizações Sociais de Saúde (OSS): Privatização da Gestão de Serviços de Saúde ou Solução Gerencial para o SUS? Gestão e Saúde 2016; 7(2):828-850..

When evaluating the management capacity, in terms of the organizational dimension, we identified that the indicators “monitoring and evaluation of actions” and “regulation” must be prioritized by state-level management. These indicate the weakness in strategies of the permanent evaluation of the services and public policies, which are required in order to make decisions in real time, acting upon evidence. We do understand, however, that the evaluation practices at SUS are not completely institutionalized³⁴34 Tanaka OY, Melo C. Avaliação de Serviços e Programas de Saúde para a Tomada de Decisão. In: Rocha AA; Cesar CLG. Saúde Pública: Bases Conceituais. São Paulo: Atheneu; 2008.. Concerning regulation at the moment of the evaluation, there was a regulated procedure only for the phase of solicitation and renewal of treatment continuity. The creation of a best practices manual is needed, which can formalize and harmonize the actions of the central and regional teams in terms of the phases of evaluation, authorization, and distribution. For Rover³²32 Rover MRM. Avaliação da capacidade de gestão do Componente Especializado da Assistência Farmacêutica em Santa Catarina [tese]. Universidade Federal de Santa Catarina, Centro de Ciências da Saúde, Programa de Pós-Graduação em Farmácia. Florianópolis: UFSC; 2016., regulations are the first step toward develop institutionalized activities and demonstrate the degree of interest and commitment with the establishment of procedures and norms which legitimize and make feasible the organization of CEAF activities.

However, up to the moment of this evaluation, there was no list of medicine out of stock that was easily available and accessible to the population of the state of São Paulo. During data collection, the managers informed us that they send such information weekly to the FME and the municipalities, and that the information was not passed to the population. Therefore, to improve the information flow and to provide more transparency to the management of CEAF, an online website is being created, which will allow the patients, individually, to access information on the availability of medicine and justification in case it is not available. In this sense, only the indicator participation and decentralized access stood out positively, achieving results that should be maintained and perfected. We observed that management had participated in many formal instances (CIB, CES, meetings for the creation of the PES); however, there are weaknesses in terms of involving the participants of CEAF (patients, doctors, among others) in the formulation of policies and directives for this component. We highlight that the creation of new strategies is needed in order to boost the creation of policies in a more participative and transparent manner. In terms of decentralized access, the SES/SP stands out for ramifying access to CEAF medicine to 95% of the municipalities, through FME and municipal pharmacies. The state of São Paulo is the third most populous administrative unit in South America¹³13 São Paulo (Estado). Secretaria da Saúde. Diagnóstico PES 2020-2023 [acessado 2020 abr 20]. Disponível em: http://www.cosemssp.org.br/wp-content/uploads/2020/01/PLANO-ESTADUAL-DE-SAUDE-2020-2023.pdf
http://www.cosemssp.org.br/wp-content/up... ; therefore, decentralization is essential to facilitate patient access to medicine and to adjust the organization of services to local realities. However, according to Medeiros³⁰30 Medeiros AL. Assistência farmacêutica no SUS: responsabilidade compartilhada por União, Estados e Municípios. São Paulo/SP [tese]. Faculdade de Saúde Pública da Universidade de São Paulo; 2018., the proportion of the population reached by the FME and the population registered in the Regional Health Departments (RHD) is still heterogeneous, ranging from 0.4 (RHD 11, Presidente Prudente) to 10.1 (RHD 4 - Baixada Santista), meaning that, although there are accessible places in most towns, there are still different access proportions in the regions.

From six indicators evaluated in the sustainability dimension, only the manager’s profile and accessibility reached the expected levels. For the 10 most common diseases in the state, there was an average time lapse of 6 to 20 days between requesting medicine and the first delivery. In a similar study done in the state of Santa Catarina, the time lapse was 50 days³²32 Rover MRM. Avaliação da capacidade de gestão do Componente Especializado da Assistência Farmacêutica em Santa Catarina [tese]. Universidade Federal de Santa Catarina, Centro de Ciências da Saúde, Programa de Pós-Graduação em Farmácia. Florianópolis: UFSC; 2016.. Possibly, the difference in time happens because in the state of Santa Catarina, evaluation and authorization of medicine requests are done in the same provision unit, and the time lapse refers to the time it takes to distribute the medicine, from the state units (FME) to the municipal units of the region.

It is known that the delays in response are one of the causes of litigation for these medicines³⁵35 Almeida-Brasil CC, Costa JO, Aguiar VCFS, Moreira DP, Moraes EN, Acúrcio FA, Guerra Junior AF, Álvares J. Acesso aos medicamentos para tratamento da doença de Alzheimer fornecidos pelo SUS em Minas Gerais, Brasil. Cad Saude Publica 2016; 2(7):1-14.. In the state of Minas Gerais, just the average time lapse between the document registration phase for Alzheimer medication (at the regional level), until the feedback from an analyst (at central level), can be between 20 and 87 days. Therefore, the authors of this study conclude that the manager must have a better control over administrative time lapse, to make the process faster and less bureaucratic³⁵35 Almeida-Brasil CC, Costa JO, Aguiar VCFS, Moreira DP, Moraes EN, Acúrcio FA, Guerra Junior AF, Álvares J. Acesso aos medicamentos para tratamento da doença de Alzheimer fornecidos pelo SUS em Minas Gerais, Brasil. Cad Saude Publica 2016; 2(7):1-14. (p. 11).

It is also relevant to mention that accessibility of CEAF medicine depends on access to the healthcare network, which depends on diagnoses, specific examinations, appointments with specialists, and so forth. This issue, combined with the local needs and realities, must be considered due to the incorporation of the medicine, which is aimed at improving and democratizing the relevant policies⁹9 Barreto JL, Guimarães MCL. Evaluation of decentralized management of basic pharmaceutical care in Bahia State, Brazil. Cad Saude Publica 2010; 26(6):1207-1220.^,3636 Dubow C, Borba TT, Santos CR, Garcia EL, Krug SBF. Participação Social na Implementação das Políticas Públicas de Saúde: uma revisão crítico reflexiva. Saude Transf Soc 2017; 8(2):103-111.. These findings indicate that more agile flow systems are needed in order to achieve more opportune care for the patients, resulting in a more sustainable management that addresses patient needs and helps reduce judicialzation³⁷37 Rover MRM, Vargas-Peláez 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..

Only 30% of the units that distribute CEAF medicine conduct satisfaction surveys among the users. Moreover, data obtained by the Ombudsman’s offices was not used in the planning of actions. Therefore, there is a clear need to improve the relationship with users and to use the information obtained with this relationship to plan and improve services. These results reveal that there is a need to bring together the management and the client, and that the managers must create efficient communication channels which can facilitate the identification of barriers and help to overcome them, creating opportunities and a favorable environment to support decision-making⁶6 Rover MRM, Vargas-Peláez CM, Faraco EB, Farias MR, Leite SN. Avaliação da capacidade de gestão do componente especializado da assistência farmacêutica. Cien Saude Colet 2017; 22(8):2487-2499.^,3838 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..

Finally, in this realm, two indicators must be prioritized by management, since both - social control and clinical aspects - did not receive any points in the evaluation, indicating an urgent need for attention. The social control indicator showed that, in the previous year, matters related to CEAF were not listed for discussion at the State Health Council, and that every time the team attended the meetings, it was solely for the purpose of providing clarification. It is fundamentally important that CEAF matters are discussed at that management level, since strategies agreed upon at that level will be monitored by its representatives. In the State Health Council, managers can also understand demands, present projects, and seek social and political support, thus achieving sustainability and contributing to improvements in management capacity³⁰30 Medeiros AL. Assistência farmacêutica no SUS: responsabilidade compartilhada por União, Estados e Municípios. São Paulo/SP [tese]. Faculdade de Saúde Pública da Universidade de São Paulo; 2018.^,3939 Brasil. Ministério da Saúde (MS). Conselhos de saúde: a responsabilidade do controle social democrático do SUS. 2ª ed. Brasília: MS; 2013..

In relation to clinical aspects, only 0.7% of the users had a registration of treatment monitoring in the SES/SP information technology system. Therefore, there was limited capacity of evaluation and of follow-up in clinical-care information and of the impacts of CEAF on health results. Something which may contribute to solving this issue is the release of the Pharmaceutical Care Program by the Brazilian Health Ministry, in the beginning of 2018. This project is aimed at following up on the treatment (initially) of the patients with hepatitis and rheumatoid arthritis, through means of pharmaceutical appointments, which must be registered in order to continue treatment⁴⁰40 Brasil. Portal da Saúde. Ministério da Saúde lança Programa de Cuidados Farmacêuticos; 2018. [acessado 2018 abr 18]. Disponível em: http://portalms.saude.gov.br/noticias/agencia-saude/42368-ministerio-da-saude-lanca-programa-de-cuidados-farmaceuticos.
http://portalms.saude.gov.br/noticias/ag... .

It is worth mentioning that the methodology adopted for this study did not have the purpose of reaching a conclusion if the management capability in the state of São Paulo is “good” or “poor”, but instead, analyze it as a process which is in different stages of evolution, with the perspective of providing directions for the improvement of this process, indicating which points can be corrected, which investments are needed, and what is the urgency¹¹11 Guimaraes MCL, Santos SMC, Melo C, Sanches Filho A. Avaliação da capacidade de gestão de organizações sociais: uma proposta metodológica em desenvolvimento. Cad Saude Publica 2004; 20(6):1642-1650..

As an alternative to the problems identified, we suggest the planning of actions which can improve CEAF management, making it a tool which helps to clarify, monitor, and evaluate the established aims⁴¹41 Brasil. Ministério da Saúde (MS). Sistema de Planejamento do SUS (PlanejaSUS): uma construção coletiva - trajetória e orientações de operacionalização. Brasília: MS; 2009.

42 Landim ELAS, Guimarães MCL. Gestão da assistência farmacêutica. In: Gestão da Assistência Farmacêutica: Especialização à distância. Universidade Federal de Santa Catarina, Universidade Aberta do SUS. Florianópolis: UFSC; 2011.^-4343 Gerlack LF, Karnikowski MGA, Areda CA, Galato D, Oliveira AG, Álvares J, Leite SN, Costa EA, Guibu IA, Soeiro OM, Costa KS, Guerra Junior AF, Acurcio FA. Gestão da assistência farmacêutica na atenção primária no Brasil. Rev Saude Publica 2017; 51(Supl. 2):15s.. In doing so, the system can evolve from action plans to actually overcome the obstacles identified in the indicators with poorer results.

There is a need to formalize the relationship between the pharmacies, which are part of the execution phase and other health services⁶6 Rover MRM, Vargas-Peláez CM, Faraco EB, Farias MR, Leite SN. Avaliação da capacidade de gestão do componente especializado da assistência farmacêutica. Cien Saude Colet 2017; 22(8):2487-2499.. Considering that the Regional Managers Commission is the forum for negotiation and agreements concerning the regional planning of actions, services, and the distribution of an array of medicine, it is extremely important for the CEAF’s state-level management to create or reinforce strategies of participation at that management level actively working in favor of demands that involve other managers⁴⁴44 Brasil. Resolução nº 1, de 29 de setembro de 2011. Estabelece diretrizes gerais para a instituição de Regiões de Saúde no âmbito do SUS (SUS), nos termos do Decreto Nº 7.508, de 28 de junho de 2011. Diário Oficial da União, Brasília, DF, 07 dez. 2011. Seção I, p. 40.. The planning and provision of resources for SUS management is also necessary to improve the infrastructure of the units that execute CEAF activities so as to meet sanitary and legal requirements, thereby contributing to the quality of the services rendered³3 Brasil. Conselho Nacional de Secretários de Saúde (CONASS). Assistência farmacêutica no SUS: para entender a gestão do SUS. Brasília: CONASS; 2011.^,4545 Brasil. Ministério da Saúde (MS). Agência Nacional de Vigilância Sanitária. Resolução-RDC nº 44, de 17 de agosto de 2009: Dispõe sobre Boas Práticas Farmacêuticas para o controle sanitário do funcionamento, da dispensação e da comercialização de produtos e da prestação de serviços farmacêuticos em farmácias e drogarias e dá outras providências. Brasília: MS; 2009..

The improvement in the ability to identify user needs, creating ways in which this information subsidizes strategies of managerial action, as well as more social participation in the design of policies at the state level, is essential⁹9 Barreto JL, Guimarães MCL. Evaluation of decentralized management of basic pharmaceutical care in Bahia State, Brazil. Cad Saude Publica 2010; 26(6):1207-1220.^,4242 Landim ELAS, Guimarães MCL. Gestão da assistência farmacêutica. In: Gestão da Assistência Farmacêutica: Especialização à distância. Universidade Federal de Santa Catarina, Universidade Aberta do SUS. Florianópolis: UFSC; 2011.^,4646 Brasil. Ministério da Saúde (MS). Lei no 8.142, de 28 de dezembro de 1990. Dispõe sobre a participação da comunidade na gestão do Sistema Único de Saúde e sobre as transferências intergovernamentais de recursos financeiros na área da saúde e dá outras providências. Brasília: MS; 1990.. Finally, there is a need to prioritize clinical aspects, also directing the pharmacists towards care issues and improving actions of pharmaceutical care at CEAF⁶6 Rover MRM, Vargas-Peláez CM, Faraco EB, Farias MR, Leite SN. Avaliação da capacidade de gestão do componente especializado da assistência farmacêutica. Cien Saude Colet 2017; 22(8):2487-2499.. To overcome this limitation, there is a need for such measures as the development of capacitation activities focused on organizational and functional issues of the pharmacies, providing the pharmacist with a higher level of responsibility³⁸38 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..

The collection of information for this research did not include the municipal pharmacies, since those do not participate in all activities executed by the CEAF, and the activities they do execute are not formally established at the state level. However, pharmacists who are involved in pharmaceutical care were included in the validation phase of this study, in such a way that the evaluation instrument is also validated for application at that level, and the SES/SP might include, when viable, the municipal pharmacies. This study has, as a limitation, the fact that it used data referred by the people surveyed, since the units do not have or do not make the data related to the organization and management available to the general public.

Final considerations

This study demonstrates the use of indicators to evaluate the management capacity of the CEAF, taking into consideration the specificities of the organization of pharmaceutical care in the state. Considering the relevance of the issue in the national context, this study provides important information to enable and encourage the regular evaluation processes, as well as to monitor pharmaceutical care in every situation, contributing for better access and a more rational use of medicine and health resources.

The final assessment, in this state, shows the need for investments in the qualification of CEAF management in all dimensions, especially in the sustainability dimension. Improvement is fundamental in order to guarantee the integrality of medicine treatment and better health results for the population.

To achieve that, there is a need for clear and agreed upon actions, planning and evaluation which may direct the operational, technical, and human resources, making them accessible to the general population, providing more opportune, integral, and continuous care. The infrastructure problems, the absence of a pharmacist’s services to promote a better use of medicine, and the deficient relationship between management and users, as well as health professionals and other sectors of public administration, are factors that restrict access and compromise therapeutic results and the very sustainability of management.

We highlight that there are favorable points in CEAF management in the state of São Paulo, which should be maintained: its active participation in the different managerial levels of SUS, the high ramification of the distribution of medicine, the efficient management of financing, the presence of well-established methods of programing and acquisition, improvements in achieving best practices in logistics, and the existence of the position of a Pharmaceutical Care Manager.

This study provides subsidies for management qualification and access to high-cost medicine through SUS, for both managerial decision making and the improvement of services. Given the importance of CEAF to pharmaceutical care, as it covers the most expensive medicines and enables access to medicines recently incorporated at SUS, and considering the complexity of management and of the diseases involved, continual improvement in management is required, and the evaluation stage is fundamental in order to achieve this desired result.

References

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History