The clinical pharmacist's role in a high-cost medicine pharmacy: Patient-centered care

Abstract In Brazil, medicine dispensing is a pharmacy service provided within the national health system that allows the pharmacist to interact directly with the patient in order to prevent, detect and solve problems related to pharmacotherapy and health needs. However, it is known that most dispensing services provided in the country are still limited to supplying medications and, at their finest, offering advice on medication utilization. Attempts to change this scenario present new challenges the area of pharmacy, which involve the need for a patient-centered pharmaceutical service model. This paper describes the patient-centered pharmaceutical service of high-cost medicine dispensing performed at a pharmacy linked to the Brazilian Unified Health System. In the model described here, the medicine-dispensing activity is the pharmacist's main field of practice, which consists of identifying patient needs related to health care itself and medication utilization. It also aims to introduce the instrument developed (a Pharmaceutical Care Protocol) that contributed to implementing this clinical service provided by the pharmacist. The protocols guide and qualify the service by providing information that helps in evaluating the effectiveness and safety of treatments and in the preparation of the care plan and can be used as a basis for other services that intend to adopt clinical pharmacy practices.

Rising drug prices in Brazil during COVID-19 pandemic: another threat to people's health

Abstract The COVID-19 pandemic puts the healthcare systems at risk due to the still uncertain operational and financial impacts of it. The difficult economic conditions of the population also call for more attention from government officials to define strategies that guarantee access to health services and products. Maintaining the supply chain of pharmaceutical products is not only paramount to cover the immediate medical response but will be fundamental to reducing disruption of the healthcare system. Increasing drug prices during the pandemic is definitely not a strategy that contributes to access. In this sense, this commentary presents a criticism of a decision by the Brazilian government that may impact the availability in health services and the population's access to medicines necessary for the maintenance of life.

Access to high-priced medicines: inequalities in the organization and the results among Brazilian states. / Acesso a medicamentos de alto preço: desigualdades na organização e resultados entre estados brasileiros.

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.

Este estudo de caso visou caracterizar a organização do Componente Especializado da Assistência Farmacêutica (CEAF) em quatro estados, de diferentes regiões do país. A coleta de dados foi realizada junto a representantes da gestão do CEAF, os quais responderam um questionário com 20 perguntas sobre: abrangência, organização, financiamento, barreiras e facilitadores. Essas informações foram complementadas com dados de inquéritos nacionais de saúde, do DataSUS, os valores investidos e indicadores socioeconômicos. Observaram-se diferenças entre os estados em questões como a proporção de usuários e a descentralização dos serviços. Estas características parecem estar relacionadas com o grau de desenvolvimento em termos dos indicadores socioeconômicos utilizados. Destacaram-se avanços no acesso a medicamentos, apesar das dificuldades para o cumprimento dos objetivos do CEAF, como a insuficiência de recursos, de qualificação da força de trabalho e da oferta de consultas e exames necessários. Os resultados indicam avanços, diferentes formas de organização e destacam a necessidade de estudos mais aprofundados relativos aos resultados clínicos e econômicos alcançados, como uma estratégia para traçar soluções para o atendimento integral e equânime dos usuários.

Challenges in the management of high-priced drugs in the SUS: evaluation of Pharmaceutical Policy in São Paulo, Brazil. / Desafios na gestão de medicamentos de alto preço no SUS: avaliação da Assistência Farmacêutica em São Paulo, Brasil.

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.

O objetivo deste estudo foi avaliar a capacidade de gestão do Componente Especializado da Assistência Farmacêutica (CEAF) no estado de São Paulo (ESP), sob os aspectos organizacional, operacional e sustentabilidade. O desenho do estudo foi uma investigação avaliativa, com adaptação de um modelo teórico e protocolo de indicadores desenvolvido para aplicação em âmbito nacional, e validado (Grupo Nominal e Comitê Tradicional) para a aplicação na realidade do ESP. A coleta de dados, em 35 unidades, foi realizada em 2017 e 2018 e contemplou todas as áreas que participam da gestão/execução do CEAF do estado, em seu âmbito central e regional. A avaliação da capacidade de gestão foi fundamentada na análise crítica dos resultados obtidos, analisando suas fragilidades e as potencialidades. Verificou-se que a capacidade de gestão foi positiva na dimensão operacional, com desafios concentrados nas demais dimensões. Os resultados demonstraram maiores investimentos e desenvolvimento em aspectos técnicos da assistência farmacêutica, mas deficitárias em relação a aspectos como: monitoramento de resultados clínicos, regulamentação, infraestrutura e comunicação com os atores envolvidos.

Desafios na gestão de medicamentos de alto preço no SUS: avaliação da Assistência Farmacêutica em São Paulo, Brasil / Challenges in the management of high-priced drugs in the SUS: evaluation of Pharmaceutical Policy in São Paulo, Brazil

Resumo O objetivo deste estudo foi avaliar a capacidade de gestão do Componente Especializado da Assistência Farmacêutica (CEAF) no estado de São Paulo (ESP), sob os aspectos organizacional, operacional e sustentabilidade. O desenho do estudo foi uma investigação avaliativa, com adaptação de um modelo teórico e protocolo de indicadores desenvolvido para aplicação em âmbito nacional, e validado (Grupo Nominal e Comitê Tradicional) para a aplicação na realidade do ESP. A coleta de dados, em 35 unidades, foi realizada em 2017 e 2018 e contemplou todas as áreas que participam da gestão/execução do CEAF do estado, em seu âmbito central e regional. A avaliação da capacidade de gestão foi fundamentada na análise crítica dos resultados obtidos, analisando suas fragilidades e as potencialidades. Verificou-se que a capacidade de gestão foi positiva na dimensão operacional, com desafios concentrados nas demais dimensões. Os resultados demonstraram maiores investimentos e desenvolvimento em aspectos técnicos da assistência farmacêutica, mas deficitárias em relação a aspectos como: monitoramento de resultados clínicos, regulamentação, infraestrutura e comunicação com os atores envolvidos.

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.

Acesso a medicamentos de alto preço: desigualdades na organização e resultados entre estados brasileiros / Access to high-priced medicines: inequalities in the organization and the results among Brazilian states

Resumo Este estudo de caso visou caracterizar a organização do Componente Especializado da Assistência Farmacêutica (CEAF) em quatro estados, de diferentes regiões do país. A coleta de dados foi realizada junto a representantes da gestão do CEAF, os quais responderam um questionário com 20 perguntas sobre: abrangência, organização, financiamento, barreiras e facilitadores. Essas informações foram complementadas com dados de inquéritos nacionais de saúde, do DataSUS, os valores investidos e indicadores socioeconômicos. Observaram-se diferenças entre os estados em questões como a proporção de usuários e a descentralização dos serviços. Estas características parecem estar relacionadas com o grau de desenvolvimento em termos dos indicadores socioeconômicos utilizados. Destacaram-se avanços no acesso a medicamentos, apesar das dificuldades para o cumprimento dos objetivos do CEAF, como a insuficiência de recursos, de qualificação da força de trabalho e da oferta de consultas e exames necessários. Os resultados indicam avanços, diferentes formas de organização e destacam a necessidade de estudos mais aprofundados relativos aos resultados clínicos e econômicos alcançados, como uma estratégia para traçar soluções para o atendimento integral e equânime dos usuários.

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.

The benefits of a public pharmacist service in chronic hepattis C treatment: The real-life results of sofosbuvir-based therapy.

BACKGROUND: In Brazil, the sofosbuvir-based therapy was introduced in the public health system (SUS) in 2015 to treat Chronic Hepatitis C (CHC). This drug and other direct-acting antiviral agents (DAAs) represent a major advance in the HCV-infection treatment due to their high effectiveness and tolerability. However, the drug safety profile is limited by significant drug interactions and its use is restricted for their high cost. Pharmacists have the opportunity to improve patient care by monitoring the therapy, recommending strategies to guarantee treatment adherence, effectiveness and safety, preventing complications of the disease, and drug-related problems, thus reducing the cost for patients and payers. OBJECTIVE: This study aimed to assess the results of the one of the first patient group treated with sofosbuvir in Brazil and their opinions about the benefits of clinical pharmacist services in the achievement of the cure for CHC and in the management of their therapy difficulties. METHODS: This cohort study (November 2015-January 2017) enrolled 240 patients followed up by the clinical pharmacists at the University Pharmacy (UPh) of the Federal University of Santa Catarina, Brazil, during the CHC treatment. The therapeutic schemes used were sofosbuvir + daclatasvir or + simeprevir associated or not with ribavirin. At the end of the therapy, the patients provided qualitative feedback about the clinical pharmacist services. RESULTS: The study demonstrated high levels of treatment adherence (99.2% of completion rates) and effectiveness rates (Sustained Virological Response rates) (92.1%). Patients reported high levels of satisfaction with the care provided on account of the good rapport built with their pharmacist, the counseling and education on HCV-infection and on sofosbuvir-based therapy utilization, motivation for adherence, and convenient access to the pharmacist. CONCLUSIONS: The clinical pharmacist services provided by the UPh was beneficial to patients treated for CHC with the sofosbuvir-based therapy.

Judicialization of access to medicines in four Latin American countries: a comparative qualitative analysis.

BACKGROUND: The valuation of medicines as health needs vary depending on the stakeholders involved (users, prescribers, managers, etc.) and their expectations. These factors modulate the role of medicines as a health need and influence access to medicines, and could be useful to explain the rising of Judicialization of access to medicines. AIM: To conduct a comparative analysis of the causes and consequences of judicialization of access to medicines in Argentina, Brazil, Colombia and Chile from the perspective of medicines as health needs. METHODS: A qualitative, cross-country study was carried out in these 4 countries. Semi-structured interviews were conducted with 50 representatives of the different stakeholders involved in the judicialization of access to medicines, including Executive branch, Judiciary, health system managers, patient organizations. The interviews were audio-recorded and transcribed verbatim. Thematic analysis used a framework approach based on the theoretical model for medicines as health needs. FINDINGS: Representatives from Argentina, Brazil and Colombia considered judicialization of access to medicines as a widespread phenomenon in their respective countries. Meanwhile in Chile, the respondents highlighted that most lawsuits related to the right to health were filed against private insurers because of unjustified increases in the insurance premiums. The comparative analysis showed that judicialization of access to medicines emerged in the four countries regardless of the constitutional protection or the health system population coverage. Among the causes were mentioned difficulties in guaranteeing access to covered medicines and the influence of pharmaceutical marketing on needs assessment and prescription behaviours. The interviewees highlighted the pressure to health system managers to fulfil their responsibilities as a positive impact of litigation. In contrast, the funding of medicines without evidence of efficacy or safety was considered a negative impact. Only in Brazil, judicialization has had impact on R&D policies. In Colombia, litigation also encouraged the recognition of the right to health as a fundamental right and the development of policies for controlling medicines prices. CONCLUSION: The results suggest that applying the adopted theoretical model creates the possibility of identifying critical points to guide policy makers to improve the health systems performances and to control lawsuits for access to medicines.

An evaluation of governance capacity of the specialized component of pharmaceutical services in Brazil. / Avaliação da capacidade de gestão do componente especializado da assistência farmacêutica.

This paper presents application of an indicator protocol to assessment of current levels of governance capacity of the Specialized Component of Pharmaceutical Services (CEAF) in a state of the South of Brazil. We chose the theoretical referential of 'governance capacity' proposed by Carlos Matus, which reflects in the concepts of management capacity and pharmaceutical service management, due to the perception of a need to overcome the fragmentation and technicist reductionism that we believe has been imposed on the area of pharmaceutical services. Data was collected using the protocol in 74 municipal or state units. The results of the analysis indicate that the currently existing governance capacity needs improvement in all three dimensions that were evaluated, principally in relation to the aspects that seek sustainability of the governance. The model and the protocol used indicate a way forward for governance of pharmaceutical service by proposing a change from the technicist-logistical focus to an emphasis on strategic and political actions, or ones which foster greater participation and autonomy. With these results in hand, it will be possible to develop strategies for improvement of access to medicines in the SUS, in the sense that the CEAF becomes able to guarantee integrality of medicines treatments.

Avaliação da capacidade de gestão do componente especializado da assistência farmacêutica / An evaluation of governance capacity of the specialized component of pharmaceutical services in Brazil

Resumo Este artigo apresenta a aplicação de um protocolo de indicadores para a avaliação da capacidade de gestão do Componente Especializado da Assistência Farmacêutica (CEAF) em um estado do Sul do Brasil. A escolha do referencial teórico de capacidade de governo de Carlos Matus, refletido no conceito de capacidade de gestão e de gestão da assistência farmacêutica, tem por base a necessidade de superar a fragmentação e a redução tecnicista imposta à área. A aplicação do protocolo envolveu a coleta de dados em 74 unidades (municipais ou estaduais). Os resultados das análises indicam que a capacidade de gestão necessita de avanços nas três dimensões avaliadas, principalmente em relação aos aspectos que visam à sustentabilidade da gestão. O modelo e o protocolo utilizados trazem avanços para a gestão da assistência farmacêutica ao propor uma mudança do foco técnico-logístico, para as ações de natureza estratégica e política, ou que fomentem maior participação e autonomia. De posse dos resultados poder-se-á desenvolver estratégias para a qualificação do acesso a medicamentos no SUS, no sentido de que o CEAF se torne capaz de garantir a integralidade dos tratamentos medicamentosos.

Abstract This paper presents application of an indicator protocol to assessment of current levels of governance capacity of the Specialized Component of Pharmaceutical Services (CEAF) in a state of the South of Brazil. We chose the theoretical referential of 'governance capacity' proposed by Carlos Matus, which reflects in the concepts of management capacity and pharmaceutical service management, due to the perception of a need to overcome the fragmentation and technicist reductionism that we believe has been imposed on the area of pharmaceutical services. Data was collected using the protocol in 74 municipal or state units. The results of the analysis indicate that the currently existing governance capacity needs improvement in all three dimensions that were evaluated, principally in relation to the aspects that seek sustainability of the governance. The model and the protocol used indicate a way forward for governance of pharmaceutical service by proposing a change from the technicist-logistical focus to an emphasis on strategic and political actions, or ones which foster greater participation and autonomy. With these results in hand, it will be possible to develop strategies for improvement of access to medicines in the SUS, in the sense that the CEAF becomes able to guarantee integrality of medicines treatments.

Towards a theoretical model on medicines as a health need.

Medicines are considered one of the main tools of western medicine to resolve health problems. Currently, medicines represent an important share of the countries' healthcare budget. In the Latin America region, access to essential medicines is still a challenge, although countries have established some measures in the last years in order to guarantee equitable access to medicines. A theoretical model is proposed for analysing the social, political, and economic factors that modulate the role of medicines as a health need and their influence on the accessibility and access to medicines. The model was built based on a narrative review about health needs, and followed the conceptual modelling methodology for theory-building. The theoretical model considers elements (stakeholders, policies) that modulate the perception towards medicines as a health need from two perspectives - health and market - at three levels: international, national and local levels. The perception towards medicines as a health need is described according to Bradshaw's categories: felt need, normative need, comparative need and expressed need. When those different categories applied to medicines coincide, the patients get access to the medicines they perceive as a need, but when the categories do not coincide, barriers to access to medicines are created. Our theoretical model, which holds a broader view about the access to medicines, emphasises how power structures, interests, interdependencies, values and principles of the stakeholders could influence the perception towards medicines as a health need and the access to medicines in Latin American countries.

Da organização do sistema à fragmentação do cuidado: a percepção de usuários, médicos e farmacêuticos sobre o Componente Especializado da Assistência Farmacêutica / From the system's organization to the fragmentation of care: perception of users, doctors and pharmacists about the Specialized Component of Pharmaceutical Care

Resumo O Componente Especializado da Assistência Farmacêutica (CEAF) do Sistema Único de Saúde tem como objetivo garantir a integralidade do tratamento medicamentoso em nível ambulatorial. Visando analisar a percepção dos atores envolvidos sobre o Componente, foi realizada pesquisa qualitativa (grupo focal e entrevistas semiestruturadas). Observou-se que há forte dependência do CEAF em relação às outras ações estruturantes na política de saúde. Segundo os atores, a forma de organização e gestão dos serviços não propicia a continuidade da atenção, o que resulta em um cuidado fragmentado. Destacaram-se fatores como falta de articulação entre serviços e profissionais, problemas na organização dos fluxos e oferta insuficiente de serviços. Ainda o foco dos serviços farmacêuticos no medicamento, ou seja, visão minimalista da assistência farmacêutica, tem impactado de diferentes formas no cuidado ao usuário. É necessária a coordenação dos serviços adequados às necessidades em saúde, que deve se traduzir na percepção de continuidade dos cuidados na perspectiva do usuário. Desta forma, o entendimento é: o medicamento tem sido garantido, mas a integralidade do atendimento preconizada nas linhas de cuidado se vê comprometida.

Abstract The Specialized Pharmaceutical Care Component (CEAF) of the Unified Health System (SUS) aims to ensure the comprehensiveness of drug treatment in the outpatient care. In order to analyze the perceptions of the actors involved with the CEAF about this Component, a qualitative research (focus group and semi-structured interviews) was conducted. A strong dependence of CEAF in relation to other structural actions in health policy was observed. According to the actors, the current organization and management of health services do not promote continuity of care, which results in fragmented care. Factors such as lack of coordination among healthcare services and professionals, problems in the organization of flows and insufficient provision of services were highlighted. Furthermore, the focus of pharmaceutical services on medication, that means, a minimalist view, has impacted in different ways the healthcare provided for the people. Coordination of services, appropriate to health needs, should result in the perception of continuity of care from the perspective of the user is necessary In this way, it is understood that the access to medication has been ensured, but the comprehensiveness of healthcare, preconized by the "healthcare lines", is compromised.

[Access to high-cost drugs in Brazil from the perspective of physicians, pharmacists and patients]. / Acceso a medicamentos de alto precio en Brasil: la perspectiva de médicos, farmacéuticos y usuarios.

OBJECTIVE: To explore perceptions on access to medication supplied by the Specialized Component of Pharmaceutical Assistance (CEAF) within the Brazilian Unified Health System (which includes high-cost drugs) by the actors involved in the healthcare services of this component. METHOD: A descriptive, qualitative study was carried out by using a focal group with 7 users and 11 semi-structured interviews with health professionals (physicians and pharmacist) in the state of Santa Catarina. RESULTS: According to the participants, access to medicines had improved. Two main perceptions of the CEAF Clinical Guidelines were identified: the requirements constitute a bureaucracy that limits access, and the requisites increase the demand for tests and specialized healthcare services, exceeding the capacity of the healthcare services network. These assumptions generated the search for other means of access that revealed a lack of information and understanding of the right to health among the users. In addition, according to the participants, because of the difficulties of accessing services as a whole, full access to CEAF medicines is a goal that remains to be achieved. CONCLUSION: Although access to CEAF medicines has improved, there are still some difficulties in guaranteeing treatment access and comprehensiveness.

Right to health, essential medicines, and lawsuits for access to medicines--a scoping study.

Despite countries' efforts to ensure access to essential medicines, some people do not have their needs met, and often resort to the Judiciary to get access to the medicines they need. This phenomenon, known as "judicialization of access to medicines", has aroused the academia's interest in law, health and social fields. In this context, this scoping study investigates, through qualitative thematic analysis, the approach to judicialization of access to medicines (normative or social) and its possible impacts (positive or negative) described in articles published in scientific journals indexed in the main health databases prior to July 2012. 65 of 384 papers met the inclusion criteria of focusing on lawsuits for access to medicines or judicialization of access to medicines as a phenomenon; empiric studies, review articles or theoretical discussions, written in English, Portuguese or Spanish; most of them were about Brazil, Colombia and England. Results show that judicialization is a complex phenomenon that involves technical-scientific, legal and social aspects. The judicialization impacts mentioned have changed over time. In the late 1990s and early 2000s the emphasis of positive impacts predominated both on the normative and social approaches, having as main reference the movements that claimed from the States the guarantee of access to HIV/AIDS treatment. In the mid-2000s, however, there was an emphasis of the negative effects of judicial intervention, when lawsuits for access to medicines became a problem in some countries. Few studies used the social approach to judicialization. For this reason, there is not enough information about whether lawsuits for access to medicines are related to a real recognition of the right to health as an exercise of citizenship. Such aspects need to be further studied.