Specialized Component of Pharmaceutical Care: the state organization and access to medicinesAbstract
This study aimed to characterize the organization of the Specialized Components of Pharmaceutical Care (Componente Especializado da Assistência Farmacêutica - CEAF) in Brazil and to categorize the different strategies as centralized or decentralized, pointing out the limits, challenges, and potentialities for access to medicines. A retrospective quantitative study of CEAF drug dispensing data in 2023 was carried out in the 26 Brazilian states and the Federal District, with a special focus on medicines recommended for the treatment of rheumatoid arthritis (RA). Data were obtained mainly from the High-Cost Procedure Authorization (Autorização de Procedimento de Alto Custo - APAC) system. A set of indicators has been developed. Data from 210,640 users, residents of 5,086 (91%) Brazilian municipalities were analyzed. Dispensation was carried out in 189 municipalities (3.4%). Approximately half of the users of RA medications in the CEAF are in the Southeast, followed by the South and the Northeast, according to the order of demographic density. The CEAF dispensing is essentially centralized, especially in the North and Northeast. The divergences and incompleteness of databases is a problem that needs to be resolved in order to enhance their use in guiding decision-making.
Key words:
Specialized Component of Pharmaceutical Care; Access to Essential Medicines
Resumo
Objetivou-se caracterizar a organização do Componente Especializado da Assistência Farmacêutica (CEAF) no Brasil e categorizar as diferentes estratégias em centralizada ou descentralizada, apontando os limites, desafios e potencialidades para o acesso aos medicamentos. Foi realizado estudo quantitativo retrospectivo dos dados de dispensação de medicamentos do CEAF em 2023 nos 26 estados brasileiros e DF, com especial enfoque para os medicamentos preconizados para o tratamento de artrite reumatoide (AR). Os dados foram obtidos, principalmente, do sistema de Autorização de Procedimento de Alto Custo (APAC). Foi desenvolvido um conjunto de indicadores. Foram analisados dados de 210.640 usuários, residentes em 5.086 (91%) municípios brasileiros. A dispensação foi realizada em 189 municípios (3,4%). Aproximadamente, metade dos usuários de medicamentos para AR do CEAF estão na região Sudeste, em seguida Sul e Nordeste, dado que acompanha a ordem da densidade demográfica. Encontrou-se divergências entre as bases de dados. A dispensação do CEAF é essencialmente centralizada no Brasil, em especial no Norte e Nordeste. As divergências e incompletudes das bases de dados é um problema que precisa ser resolvido para potencializar seu uso de modo a balizar a tomada de decisão.
Palavras-chave:
Componente Especializado da Assistência Farmacêutica; Acesso a Medicamentos Essenciais
Resumen
Se tuvo como objetivo caracterizar la organización del Componente Especializado de la Asistencia Farmacéutica (CEAF) en Brasil y categorizar las diferentes estrategias en centralizadas o descentralizadas, señalando los límites, desafíos y potencialidades para el acceso a los medicamentos. Se realizó un estudio cuantitativo retrospectivo de los datos de dispensación de medicamentos del CEAF en 2023 en los 26 estados brasileños y el Distrito Federal, con especial énfasis en los medicamentos recomendados para el tratamiento de la artritis reumatoide (AR). Los datos se obtuvieron principalmente del sistema de Autorización de Procedimientos de Alto Costo (APAC). Se desarrolló un conjunto de indicadores. Se analizaron datos de 210.640 usuarios residentes en 5.086 (91%) municipios brasileños. La dispensación se realizó en 189 municipios (3,4%). Aproximadamente, la mitad de los usuarios de medicamentos para AR del CEAF se encuentran en la región Sureste, seguida por el Sur y Noreste, dato que sigue el orden de la densidad demográfica. Se encontraron divergencias entre las bases de datos. La dispensación del CEAF es esencialmente centralizada en Brasil, especialmente en el Norte y Noreste. Las divergencias e incompletitudes de las bases de datos constituyen un problema que debe resolverse para potenciar su uso y orientar la toma de decisiones.
Palabras clave:
Componente Especializado de la Asistencia Farmacéutica; Acceso a Medicamentos Esenciales
Introduction
In Brazil, access to medicines is a constitutional right, guaranteed through public policies within the scope of the Unified Health System (SUS). The National Pharmaceutical Policy (Política Nacional de Assistência Farmacêutica - PNAF), approved by the National Health Council in 2004, integrated several public policies implemented throughout the country’s history, such as the Generic Medicines Law (1999), the National Medicines Policy (Política Nacional de Medicamentos - PNM - 1998), the adoption of the List of Essential Medicines (Relação dos Medicamentos Essenciais - RENAME), among others, which make up the legal framework for guaranteeing access to medicines and pharmaceutical care in SUS1.
In the 20 years of the PNAF, the availability and rational use of medicines have represented an important advance, encompassing the increase in the RENAME list, the promotion of national production, and the implementation of pharmaceutical care. However, difficulties still persist in obtaining comprehensive treatment through the SUS, triggering direct out-of-pocket expenses by users, lawsuits, and treatment inefficiencies2,3.
Pharmaceutical Care in Brazil is organized into three funding components, among which is the Specialized Pharmaceutical Assistance Component (Componente Especializado de Assistência Farmacêutica - CEAF). This component aims to provide comprehensive outpatient care to users in all phases of chronic-degenerative diseases, including rare diseases. The care pathways outlined in the Clinical Protocols and Therapeutic Guidelines (Protocolos Clínicos e Diretrizes Terapêuticas - PCDT) are essential to understand the treatment lines, safety, and rational use of medicines that are part of the CEAF4.
To have a more profound understanding of the access to medicines, including those included in the CEAF, different attributes of analysis were conferred over time, such as geographic accessibility; availability; acceptability; purchasing power; as well as cultural, educational, and socioeconomic aspects5-7.
Geographic accessibility is related to the adequate distribution and location of service points. This attribute refers to the user’s proximity to a given location, encompassing the means they use to transport themselves8. This is a particularly important attribute in the CEAF, since many patients have diseases that cause disabilities and dispensing occurs at points designated by the state administration, implying displacements by users, often from one municipality to another.
The different state strategies in the organization of CEAF services impact access to treatment. Initiatives, such as the decentralization of service locations, home delivery, and digital request, are presented as facilitators for access to CEAF medicines9. However, in a country with continental dimensions, each state presents different challenges, and there is no single state management model that applies to all. Nevertheless, it is important to understand which management characteristics can facilitate access to medicines.
Rheumatoid Arthritis (RA) is a chronic, autoimmune, inflammatory disease of unknown cause. The PCDT for this disease recommends three stages of treatment: the first with Synthetic Disease-Modifying Antirheumatic Drugs (DMARDs), the second with Biological Disease-Modifying Antirheumatic Drugs (bDMARDs) or Targeted Synthetic Disease-Modifying Antirheumatic Drugs (tsDMARDs), associated or not with DMARDs, and the third stage consisting of another bDMARD or tsDMARD, distinct from the second stage, associated or not with DMARDs. Of the twenty-four medicines indicated for the treatment of RA, twenty are the responsibility of CEAF10; therefore, the study of this clinical condition may reflect characteristics of the CEAF service as a whole.
Therefore, the objective of this article is to characterize the organization of the CEAF in Brazil and categorize the different strategies as centralized or decentralized, pointing out the limits, challenges, and potential for access to medicines.
Method
A retrospective quantitative study of medicine dispensing data from the CAEF was conducted in 2023 in all of the 26 Brazilian states and the Federal District (DF), with a special focus on medicines recommended for the treatment of RA according to the PCDT 202110.
RA was chosen as a tracer to allow for a more in-depth analysis in an attempt to achieve the core aim of this article, mainly because it has a high prevalence, spread across practically all of the Brazilian states, and includes all DMARDs in the PCDT 202110, including some with high acquisition costs. Furthermore, it is a chronic disease that commonly leads to limitations in movement in its most severe stages.
Information of interest
To better identify and qualify the organizational strategies of CEAF services, indicators were developed, presented in Chart 1 according to states and/or geographic regions of the country (when necessary).
Data source
The data sources used were the High-Cost Procedure Authorization System (Autorização de Procedimento de Alto Custo - APAC), the websites of all state health departments (Secretarias Estaduais de Saúde - SES) and the Federal District, the National Database of Pharmaceutical Care Actions and Services (Base Nacional de Dados de Ações e Serviços da Assistência Farmacêutica - BNAFAR), and the disease burden study.
The APAC data referred to medicine dispensing carried out from January to December 2023, for the 27 states. These were obtained from the Outpatient Information System of the Unified Health System (Sistema de Informação Ambulatorial do Sistema Único de Saúde - SIA/SUS) database, made available by the Department of Informatics of the SUS (Departamento de Informática do SUS - DATASUS), by accessing the website https://datasus.saude.gov.br. The APAC system aims to control and pay for high-cost procedures, including CEAF medicines. The APAC number is generated after the manager authorizes the dispensing of the medicine to the user. The medicine request requires the presentation of specific documents and examinations foreseen in the PCDT, according to each patient’s clinical condition.
Medicine dispensing and patients who received pharmaceutical care were selected from the APAC, using TABWIN software, filtering the variable that indicated the main diagnosis by the International Classification of Diseases - version 10 (ICD-10) of all ICD-10 codes present in the 2021 PCDT for RA, namely: M05.0 Felty’s syndrome; M05.1 Rheumatoid lung disease; M05.2 Rheumatoid vasculitis; M05.3 Rheumatoid arthritis with involvement of other organs and systems; M05.8 Other seropositive rheumatoid arthritis; M06.0 Seronegative rheumatoid arthritis; and M06.8 Other specified rheumatoid arthritis.
To identify the locations offering CEAF medicine dispensing services, data available on the websites of all state health departments (SES) and the Federal District were collected. As a complement, and to further quantify the dispensing locations, in comparison to those mentioned in the APACs, the BNAFAR was also consulted, but only regarding information on the total number of national health establishment registries (Cadastros Nacionais de Estabelecimentos de Saúde - CNES) that had dispensed medicines for RA during the same analysis period as the APAC.
The 2008 disease burden study was used to obtain prevalence data11.
Operational Aspects
Data was obtained from the SIA/SUS APAC drug database for the year 2023, including the number of aggregated dispensations (regardless of the medicine), both according to the patient’s municipality of residence and the municipality where the dispensation took place, as well as the respective state. In each state, the number of municipalities of residence where patients who originated the APACs were located and the total number of dispensing points in health establishments (according to the CNES variable) were identified in order to allow for the discrimination of the centralization/decentralization aspect of the CEAF service organization.
The BNAFAR data were accessed through the access to information law. A BNAFAR report for the year 2023 was requested for all states regarding the dispensing of CEAF medicines for the same ICD-10 codes cited as a selection filter for the APAC-medicine database in TABWIN.
Analysis
The distribution of dispensing locations is presented by geographic region (N=North; NE=Northeast; SE=Southeast; S=South; MW - Midwest); and by state - Acre (AC), Amapá (AP), Amazonas (AM), Pará (PA), Rondônia (RO), Roraima (RR), Tocantins (TO), Mara nhão (MA), Piauí (PI), Ceará (CE), Rio Grande do Norte (RN), Paraíba (PB), Pernambuco (PE), Alagoas (AL), Sergipe (SE), Bahia (BA), São Paulo (SP), Rio de Janeiro (RJ), Minas Gerais (MG), Espírito Santo (ES), Paraná (PR), Santa Catarina (SC), Rio Grande do Sul (RS), Federal District (DF), Goiás (GO), Mato Grosso (MT), and Mato Grosso do Sul (MS) (Table 1) for each of the sources where the data was obtained. The indicators were calculated by geographic region.
For a better viewing of geographic accessibility and the degree of centralization/decentralization of the organization of CEAF services, a map was created in QGIS software, version 3.36, showing: (1) the distribution of dispensing municipalities (each point on the map representing a municipality where there is at least one CNES that dispensed medicine for RA in the year 2023) and (2) the “area of influence” of a dispensing municipality. A given municipality is in the “area of influence” of a dispensing pharmacy/health establishment (CNES) when the majority of medicine dispensing for patients residing in this municipality come from the dispensing municipality. Thus, each area color on the map represents a dispensing cluster.
Thus, from this visual resource, it is possible to observe that the states with greater color variation (more areas painted in different colors or more clusters) reflect a more decentralized organization of CEAF services for RA and, by contrast, those states entirely painted with a single color (“blotch”) are characterized by a more centralized service organization, with very few, or generally only one, dispensing location (CNES) referred to in the APAC system.
Results
In 2023, 210,640 users were treated at the CEAF for RA. On average, each patient received 8.8 medicine dispensations, totaling 1,855,624. Users residing in 5,086 municipalities (91%) were identified, confirming the high prevalence of RA in Brazil and its spread throughout the national territory.
According to APAC, only 189 municipalities (3.4%) dispensed medicine for RA. In 15 states, the service was only registered in the capitals. These states correspond to AM, the largest in territorial area AP, and RR; the three states of the Midwest region and the DF; the six states of the Northeast region, not including BA, PB, and RN; RJ; and SC (Table 1).
The discrepancy in the information regarding the number of locations dispensing medicine from the CEAF is evident (Table 1). BNAFAR did not present data for seven states throughout 2023, indicating the fragility of this database, especially for those that do not use the Horus system, which is the case for the states of AM, RR, BA, MS, ES, MG, and SC.
The SES websites show citizens the locations where the medicine can be accessed. However, out of the 27 states, eight of them indicate only one service location. When compared with APAC, this number increases to 15 states, which can be attributed to the use of the same CNES at different addresses. On the SES websites, the states of MG and SC had more than 300 CEAF dispensing locations. However, in APAC, MG has records in only 18 locations and SC in only one (Table 1).
Approximately half of the users of RA medicines from the CEAF are located in the Southeast region, followed by the South and the Northeast, a figure that follows the order of population density. When comparing the distribution of the population that obtains RA medicines from the CEAF with the percentage distribution of the general population, it could be noted that the South and Southeast regions had a higher concentration of people with RA listed in the APAC (Table 2).
The indicator ‘average number of municipalities of residence served by a dispensing municipality’ expresses the centralization of services. When analyzing Brazil as a whole, we can see that a dispensing municipality serves an average of 27 municipalities of residence. However, it should be noted that the entire Midwest region has only four municipalities dispensing RA medicines in the APAC, while it has 467 municipalities, of which 444 have RA patients served at the CEAF according to APAC data, that is, each service municipality (distributer) is responsible for, on average, serving people from 111 different municipalities (Table 2).
Based on the disease burden study conducted in Brazil in 2008, the prevalence of RA in 2023 by region of the country is estimated (Table 2), leading to a projection of 754,189 cases of RA in Brazil. As previously stated, according to the 2023 APAC, only 210,640 people had access to medicines for RA treatment through the CEAF, representing approximately 28% of the prevalent RA cases.
The map showing the distribution of municipalities dispensing medicine for RA and their area of influence according to APAC 2023 (Figure 1) visually demonstrates the location of the service municipalities (distributers). The large areas are the states with centralized (or concentrated) organization, such as SC, CE, RJ, and all the states in the Midwest region, etc. It is also important to highlight the state of Pernambuco (PE), which is almost entirely blank on the map, suggesting some anomaly in the completion of the APACs, since, as observed in Table 1, among the 185 municipalities in the state, only 20 are municipalities of residence of patients referred to in the APAC who received RA medicines.
Map showing the distribution of municipalities mentioned in the APAC as responsible for dispensing medications for RA (points on the map) and their "area of influence" (color variation - clusters), considering the municipalities with patients treated. Brazil, 2023.
Discussion
The coordination of public policies in Brazil, a country of continental dimension, presupposes regionalized and hierarchical action among the three spheres of government. To provide SUS services in a universal, comprehensive, and equitable manner, the division of responsibilities between the Federal Government, the 26 States, the Federal District and the 5,570 municipalities is crucial12. The PNAF, as an integral part of the National Health Policy, follows the agreements for the organization of SUS services, which have decentralization as one of their organizational principles. This differs from municipalization, as services with different technological densities must be offered in a coordinated manner13. Pharmaceutical care permeates all levels of SUS care, that is, from low to high complexity. Medicines are essential inputs that must be under qualified management at all levels.
The geographic accessibility of the CEAF proved to be quite heterogeneous among the states. Users residing in municipalities located far from large urban centers, especially in states where CEAF services are only offered in the capitals, will most likely incur significant time and financial costs for travel and difficulties in adhering to treatment, since medicine is only distributed monthly.
Both the centralization and decentralization of dispensing centers should be carefully weighed for their pros and cons, and the source of observation should be considered, given the divergence, in some states, among the information collected in the APAC, on websites, and in BNAFAR.
The centralization of CEAF services in a few establishments generates, in addition to inefficiency regarding geographic accessibility, an overload of work for the professionals responsible for this task. Pharmacists do not have enough time to perform care services, likely limiting themselves only to the management and delivery processes of the medicines themselves4. Litigation, lack of infrastructure, and delays in meeting user demands can also be consequences of high centralization. By contrast, the decentralization of services generates higher infrastructure costs and requires a greater number of professionals, a fact that triggers an increasing demand for financial resources and needs to be prioritized to become a reality14.
When comparing the distribution of the general population in each geographic region with the proportional distribution of RA patients who accessed CEAF services, according to the country’s geographic regions, significant inequality was observed in the North and Northeast regions. That is, in these regions, a smaller proportion of those who accessed the CEAF was observed when compared to other regions. This situation was also observed from the indicator “Distribution of the percentage of APAC patients in relation to the total estimated prevalent cases”, which shows approximately 28% coverage nationally, with significant variation between regions: only 10% in the North region as compared to 54% in the Southeast region.
Furthermore, the Southeast and South regions have states with a greater decentralization of CEAF services and present a higher percentage of patients when compared to the total population in general, exemplifying the regional disparities in access to medicines in Brazil7,15.
After analyzing the differences in the organization of CEAF services in the states and observing that users diagnosed with RA from 91% of municipalities are served, there is a clear need to address possible challenges in obtaining the necessary medicines. Despite a repressed demand, according to the projection by prevalence rate, there was a 26% increase in RA users who obtained medicines from the CEAF with reference to 201916. This increase may also be a consequence of the worsening of the disease, as the first line of treatment for RA, according to the PCDT 2021, includes affordable DMARDs, such as methotrexate 2.5 mg (price of 30 tablets ranges from R$ 33.11 to R$ 42.45)17. Therefore, some users may prefer to pay out of pocket instead of seeking out the CEAF to obtain the medicine, thus facing bureaucracy. As the disease worsens and treatment needs to be changed, the monthly costs for out-of-pocket payments become much higher, ranging from R$ 380.1917 to R$ 6,114.24 (on average)18. Due to the higher cost, the demand for CEAF services is greater for second-line treatment.
Scientific literature19-21 reports experiences related to the organization of CEAF dispensing that demonstrate decentralization as an important factor in improving access. These experiences are concentrated in the South and Southeast regions, confirming the higher concentration of users in these regions.
As a first example, we present the case of the Paraná Pharmacy, which, in 2017, carried out a pilot project for home delivery of CEAF medicines for elderly users (over 60 years of age) residing in Curitiba, representing 34.73% of the total users served at that pharmacy. The authors considered that this strategy improved both access for this vulnerable population and the flow of other users in the pharmacy, in turn reducing waiting time19.
The state of RS developed a platform called Farmácia Digital RS, implemented in 2020, aimed at carrying out the consultation, request, and renewal of CEAF medicines digitally. This strategy facilitated user access and enabled the pharmacist to perform care services20.
The Decentralization Policy of the Specialized Component of Pharmaceutical Assistance (DPCEAF) implemented in Minas Gerais in 2021 had a 72% participation from municipalities by November 2023. Of these, 41% were carrying out the opening of processes and dispensing of medicines. By 2023, R$ 45.9 million had been invested in infrastructure improvements and R$ 15.3 million in the operating costs of pharmaceutical services in these units. The expansion of access to medicines was estimated at around 9,000 new users, which corresponds to a 14% increase in the number of people served by this component in this state21.
In addition to the experiences reported in the literature, there are also the home delivery of medicines from the CEAF in the Federal District or the decentralization of distribution centers in the state of Rio de Janeiro, which are known to the authors but are not available in the scientific literature, nor on the websites of the State Health Departments or in official databases.
Our study highlighted the weakness of the data at locations where CEAF medicines are dispensed, given the discrepancies in the information recorded in the APAC, BNAFAR, and State Health Department websites. APAC is probably the most reliable data source at the state level, as it supports the allocation of resources. BNAFAR data is comprised of different information systems that do not interoperate, generating asymmetries and difficulties in compatibility with the national database. The analysis of the centralization of services was especially divergent for the states of CE, MT, MG, SC, and RJ, since the APAC record of municipalities that dispense medicines is much lower than that reported on the State Health Department websites, which reflects reality. Evidence-based public management is one of the best strategies for decision-making in public policies. Based on reliable data, it is possible to understand the strengths and weaknesses of a given action that has been implemented and to improve it so as to achieve the intended goals.
The concentration of dispensing location information in APACs can be understood by the greater ease of organization and accountability to the Federal Court of Accounts (Tribunal de Contas da União - TCU). As CEAF medicines represent the largest share of annual spending on the acquisition of AF supplies (approximately 4.87 billion reais22), one of the possibilities for this option by the SES would be that the concentration of information would contribute to security in the execution of CEAF by the state management. However, the concentration of information from different locations may hinder the traceability of any problems that occur in specific locations. It should be noted that, in order to monitor medicine dispensing and support decision-making, the information on dispensing locations must be adjusted to the respective actual CNES.
In addition to the usual limitations of using secondary databases, such as consistency and reliability, a problem that in our case was expressed by the divergence of information between them, we highlight here some problems with the estimation of coverage of access to RA treatment by the APAC. The best available data identified for RA prevalence was generated in a study undertaken in 2008; therefore, it may differ considerably from the present. In addition, many patients may obtain their medicines in the private network. It is also worth mentioning that searching for information on the websites of the State Health Departments does not allow for the identification of specific dispensing locations for RA.
Strengths of the study include the use of national data, covering all states, and triangulating different databases. RA, a tracer disease, has a high prevalence and a national range, and its treatment consists of high-cost medicines. The identification of clusters of areas of influence of dispensing establishments proved to be an interesting strategy regarding the centralization/decentralization of the CEAF, suggesting that it could be applied to other diseases.
Conclusion
It can be said that the CEAF is essentially centralized, where most medicines are expensive to acquire and many users have debilitating illnesses, for whom geographic accessibility is particularly important.
In a component that brings together such characteristics, good information for management, as well as for good communication with users and civil society, is especially relevant. Thus, it is important to highlight the divergence of information between databases. It is necessary to broaden the proper approach to the topic in the scientific literature, as well as in databases, so as to guide toward the best choices according to the context of each state.
It is essential to increase the number of dispensing locations, provided that the quality of the service is guaranteed. Home delivery lacks better evidence regarding the feasibility of operation, guarantee of the success factors of dispensing, as well as the costs involved.
This study prompted reflections and recommendations for improving the PNAF and inter-federative articulation.
It is of utmost importance, based on existing systems, to implement an effective and transparent system to monitor the quality of CEAF’s operational records, including information on financial transactions, among other managerial and clinical aspects.
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The data sources adopted in the research are indicated in the article’s body.
Notes: Number of municipalities, in parentheses, referred to in the 2023 APAC, which dispensed medications for RA by state: Acre (2), Amapá (1), Amazonas (1), Pará (13), Rondônia (5), Roraima (1), Tocantins (4), Maranhão (1), Piauí (1), Ceará* (1), Rio Grande do Norte (7), Paraíba (2), Pernambuco (1), Alagoas (1), Sergipe (1), Bahia (31), São Paulo (28), Rio de Janeiro* (1), Minas Gerais* (28), Espírito Santo (14), Paraná (22), Santa Catarina* (1), Rio Grande do Sul (18), Federal District (1), Goiás (1), Mato Grosso* (1) and Mato Grosso do Sul (1). *The number of municipalities that dispense CEAF at the APAC in the states of Ceará, Mato Grosso, Minas Gerais, Santa Catarina, and Rio de Janeiro is much lower than that reported on the SES websites. Source: Authors.