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.

[Priorities of clinical drug trials in Brazil and neglected diseases of poverty]. / Prioridades da pesquisa clínica com medicamentos no Brasil e as doenças da pobreza.

OBJECTIVE: To identify clinical drug trials performed in Brazil between 2012 and 2015, with emphasis on those focusing on neglected diseases of poverty. METHOD: Two clinical trial registries, ReBEC (Brazilian registry) and ClinicalTrials.gov were surveyed. The following aspects were investigated: distribution of clinical trials in relation to the burden of disease in Brazil, distribution of trials regarding their focus on diseases of poverty vs. diseases not linked to poverty, phase of trials, performing institution, and type of funding (private, public, or mixed). RESULTS: The search revealed 866 eligible trials, 88 registered in ReBEC and 778 in ClinicalTrials.gov. Of these, 73 (8.5%) were phase I trials, 610 (70.5%) were phase II and III trials, and 183 (21%) were phase IV trials. There were 38 trials (4%) focusing on neglected diseases of poverty. Regarding the burden of disease, 734 (84.8%) trials focused on noncommunicable diseases, which in fact represent the largest burden of disease in Brazil. Most trials were carried out by pharmaceutical companies (55.3%), with predominance of private funding (57.1%); however, if only the diseases of poverty are considered, 63.1% were financed by public resources. CONCLUSIONS: The clinical drug trials carried out in Brazil in the study period are in agreement with the proportional burden of disease for the country. However, the neglected diseases of poverty were not prioritized. More effective action is necessary to redirect clinical research on drug development to meet national needs.

[Indicators for drug selection in health systems: an integrative review]. / Indicadores da seleção de medicamentos em sistemas de saúde: uma revisão integrativa.

OBJECTIVE: To produce a panel of the main drug selection indicators by performing an integrative literature review. METHODS: After the elaboration of a review protocol, searches were conducted in LILACS, MEDLINE, Embase, and SciELO databases. The following search terms were used: "indicators"; "criteria"; "drug selection"; "pharmacy and therapeutics committee"; and "medication form"; with the applicable variations in English and Spanish. Sixteen original articles published between January 1996 and March 2012 were retrieved and reviewed to compose a panel of indicators. RESULTS: Forty-five quantitative and qualitative indicators were identified. These indicators were grouped according to conceptual similarities in three categories: 1) assessment of pharmacy and therapeutics committee structure; 2) evaluation of the general processes of drug selection; and 3) evaluation of the results of drug selection. CONCLUSIONS: The indicators identified reveal relative uniformity in the established patterns for drug selection. The group of indicators established in this study should serve as reference for the development and consolidation of drug selection in public health services.

Role of pharmacists in the context of rare diseases: a scoping review protocol.

INTRODUCTION: Rare diseases are chronic conditions, generally incurable, progressive and disabling, which may result in early death. Access to therapeutic products, both medicines and appropriate medical devices, is essential to prevent the progression of the disease and maintain the patients' quality of life. Pharmacists can be part of health teams, in charge of guiding patients' journey, monitoring pharmacotherapy and identifying risks. This scoping review aims to identify and summarise evidence on the role of pharmacists and its impact in the field of rare diseases. METHODS AND ANALYSIS: The searches will be conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses reporting guideline for protocols. Three electronic databases will be consulted. Studies reporting on qualitative and/or quantitative data from any world region will be considered. There will be no language or initial time limit for studies inclusion, until December 2022. To be eligible for inclusion, studies must focus on the role pharmacists in clinical services aimed at promote the access to medicines, prevention and resolution of problems related to pharmacotherapy. No assessments of items' quality will be made, as the purpose of this scoping review is to synthesise and describe the coverage of the evidence. Clinical, humanistic or economic outcomes from studies that meet the inclusion criteria will be included in the review. The analysis will synthesise the available evidence and may be able to push pharmaceutical practice forward, aiding professionals, educators and managers in the implementation of new approaches to better meet the needs of rare diseases and providing opportunities for future research. ETHICS AND DISSEMINATION: Primary data will not be collected in this study and formal ethical approval is not required. The findings of this study will be disseminated through peer-reviewed publications and conference presentations.

Initiatives to promote access to medicines after publication of the Brazilian Policy on the Comprehensive Care of People with Rare Diseases.

BACKGROUND: Rare diseases affect a small number of people compared to prevalent diseases. The vast majority of these diseases are of genetic origin, have no cure, are chronic and can lead to death. Although the right to access medicines is included in the constitutionally guaranteed right to health in Brazil, problems in the supply of medicines for rare diseases are reported in the country. This study aimed to describe and analyse the initiatives to promote access to medicines for treating rare diseases in the Unified Health System, Brazil, after the publication of the Brazilian Policy on the Comprehensive Care of People with Rare Diseases. Based on the model published by the WHO Regional Office for Europe, which described access to medicines in prelaunch, perilaunch and postlaunch policies, the initiatives referring to each category were summarized based on documentary research searched in online databases from January 2014 to December 2020. RESULTS: Different actions and policy interventions were identified, which went through the expansion of resources for research and development, health regulations, incorporation of new drugs, review and publication of clinical guidelines, and expansion of the network of care facilities by the Ministry of Health. On the other hand, aspects related to care policies, pricing methods, technological development, and development of pharmaceutical service processes were not implemented. CONCLUSIONS: Although it is impossible to determine the explicit motivation of such actions concerning the Policy, its publication certainly was a landmark in Brazilian society, allowing greater recognition of the needs of rare disease patients and the specificities of treatment'. However, this study suggests that the steps that make up the life cycle of medicines are not linked, lacking articulation and integration of the care network, and consequently, there is no evidence that rare disease policy publication has generated a broad impact on the promotion of access to medicines to treat rare diseases in Brazil.

Availability of emergency contraception in large Brazilian municipalities: a guaranteed right?

Introduction: Emergency Contraception (EC) is available in Brazil since 1996, when it was adopted as one if the family planning strategies and, in 1998, for use in services assisting victims of sexual violence. In the country, its use is regulated by guidelines. Its access through SUS (Unified Health System), however, does not seem to occur in a standardized manner. Methods: The aim of the study was to analyze the availability and barriers to accessing emergency contraception (levonorgestrel) in Brazilian municipalities with more than 500 thousand inhabitants. The survey was carried out by a form sent to the Municipal Health Departments (SMS) managers and a search on the list of standardized medicines by the hospitals in the same municipalities. Results: The Basic Health Units were identified as the standard access places to EC. However, one of the obstacles mentioned is the need for a prescription for dispensing in almost 80% of the analyzed cities. Access in emergency situations at night and on weekends is also uncertain, since although 67% of the places stated that they dispense at the hospital level, the item was only standardized in 21% of the hospital lists. Discussion: The difficult access this drug in the public system essentially tends to harm the poorest women, who are the ones who suffer most from the consequences of an unwanted pregnancy.

Transforming pharmaceutical education: A needs-based global analysis for policy development.

Background: A needs-based approach is desirable for the transformation of pharmaceutical education, and to link pharmaceutical education with the health needs of populations and national priorities. There are varying levels of data in the literature on the status of pharmaceutical education in all six World Health Organization (WHO) regions, especially in the context of needs identification and evidence-based policy interventions. The framework for this study was the FIP Development Goals. Objectives: The aim of the study was to develop evidence-based policies through a needs-based approach for pharmaceutical education transformation nationally, regionally and globally by addressing the following objectives: 1. Identify global and regional needs in pharmaceutical education, through a regional SWOT analysis and prioritization of FIP development goals; 2. Develop valid and credible regional roadmaps for pharmaceutical education advancement according to the identified prioritized goals and 3. Develop a global call to action as a policy intervention for advancing pharmaceutical education. Methods: This study was conducted between 2020 and 2021 using a mixed methods approach. Surveys of higher education institutions and a series of qualitative interviews were conducted with national professional leadership organizations, with further regional workshops having 284 participants recruited from the International Pharmaceutical Federation (FIP) membership base, spanning all six WHO regions. Results: Eleven out of 21 FIP DGs were identified as priorities for regional roadmaps and FIP DG 1 (Academic capacity) was identified as a priority in four regions. All regions had distinctive results with an area of commonality between them. There were common weaknesses in the adoption of competency-based education and inter-professional education. Conclusions: It is critical for every country and region to develop needs- and evidence-based policies for the transformation of pharmaceutical education, for which FIP DGs provide a systematic framework.

A broad view of pharmaceutical services in multidisciplinary teams of public Primary Healthcare Centers: a mixed methods study in a large city in Brazil.

AIM: This study aims to describe how the pharmaceutical services are performed in Primary Healthcare Centers of the Brazilian Public Health System in a large city. Background: There is extensive international discussion about the role of pharmacists in health care teams, particularly in Primary Health Care (PHC). However, in Brazil, there is still no consensus on what services the pharmacist should perform in multidisciplinary teams in PHC. METHODS: This study used mixed methods research, and it was conducted with 200 pharmacists who work in PHC Centers of the public health system in São Paulo. The study was conducted using a focus group and an online survey, and qualitative and quantitative data were obtained. FINDINGS: The analysis of the data from the focus group showed two central themes: (i) pharmaceutical services go beyond medicines and (ii) the contributions of the pharmacist to a multidisciplinary team work in PHC. The survey explored 29 services provided by pharmacists, 7 of which were provided daily. It is important to emphasize that pharmacists do not differentiate the relevance attributed to services considered clinical from those that are managerial or more related to access to medicines. This is an opportunity to develop their teamwork skills. Hence, it is necessary to consolidate the professional identity of the pharmacist and to organize their work processes in a multidisciplinary team. PHC is a space that allows a wide development of pharmaceutical services.

Comparative analysis of the use and control of thalidomide in Brazil and different countries: is it possible to say there is safety?

INTRODUCTION: One of the biggest drug disasters in history has not prevented thalidomide from being used to treat various clinical conditions. Currently, Brazil has a worrying scenario: high consumption of the drug and, cases of pregnant women using thalidomide, even after adopting restrictive legislation. AREAS COVERED: This review of the literature and legislation sought to comparatively analyze the monitoring of thalidomide use in Brazil and other countries that use this drug. Finally, we discuss the differences between the countries. EXPERT OPINION: This analysis allows us to think beyond the safe use of thalidomide, but the safety provided by any type of monitoring system. It seems that out-patients that use unsafe drugs are exposed to some degree of risk. To improve safety, more extensive improvements are needed than monitoring systems related to the use of thalidomide. Its safe use depends on a drastic reduction in the incidence of leprosy and Erythema Nodosum Leprosum in the world; investment in research and development of safe and effective therapeutic alternatives to thalidomide; improvement of health systems and their health surveillance systems, particularly in primary health care; awareness of health professionals and patients for greater responsibility in the use of medicines, especially thalidomide.

Transparency of data on the value chain of medicines in Argentina, Brazil, and Colombia.

Introduction: The transparency of data on the value chain of medicines is crucial for the study and monitoring of the pharmaceutical system. These data may impact medicine pricing negotiations, contribute to patient access to pharmaceutical products, and strengthen health systems. Objective: This study analyzed the national strategies to ensure the transparency of data from medicine cost development to marketing in Argentina, Brazil, and Colombia. Method: A descriptive study was carried out by searching databases, reports, documents, and scientific articles published between January and August 2022 related to rules on transparency and databases, including 1) marketing authorization; 2) pricing; 3) intellectual property; 4) clinical trials; 5) research and development (R&D); and 6) health technology assessment (HTA) of selected biopharmaceuticals. Results: Transparency data, rules, and information are not uniform. The infostructures (organizational capacity for collecting and distributing information) regarding the pharmaceutical value chain in these three countries face limitations in appropriate measures to publicly share data and evidence, including pre-clinical data, clinical data, and costs. None of the countries require transparency about data on research and development costs. All three countries present similar publicization of data on marketing authorization and intellectual property, with some differences. The significant limitations in Argentina include the absence of formal price regulation and data on the volume of medicine purchased and respective amounts paid. Among the three countries, Brazil showed a higher degree of information transparency, perhaps due to the legal regulation that guarantees citizens access to information of public interest. Brazil also stands out in terms of the public availability of HTA reports and pricing, in addition to the highest volume of information. In contrast, Colombia has in place a decree that allows 5 years of trial data exclusivity for new medicines, an act contrary to data transparency. Despite the different stages of transparency, no country has evidenced a robust use of these data in public policy decision-making. Conclusion: The results reinforce the presence of information asymmetry between stakeholders, data fragmentation, data gaps and overlap, and difficulty in comparing available data across the three countries and the use of these data nationally to produce evidence.

Transforming uncertainties into legitimate regulation? NICE and CONITEC agencies' decisions on rare diseases. / Transformando incertezas em regulamentação legitimadora? As decisões das agências NICE e CONITEC para doenças raras.

As a scientific and technological practice, the evaluation of health technologies (HTA) is, at the same time, a challenge to determine the value of the technologies to be incorporated. This study aimed to explore and compare the results and technical elements of the evaluations issued for rare diseases between the English (NICE) and the Brazilian agency (CONITEC). The first part of the study involved the systematic search for evaluations from 2013 to 2019. In the second stage, the reports were analyzed based on: (i) descriptive narrative review; and (ii) calculation of the absolute and relative frequency according to each domain and component (element) applied in the European HTA network model. Twenty-four medicines were distinctly assessed during the study period. Through 126 questions (elements) distributed among nine domains, the analysis revealed that 67 (53.2%) and 44 (35.0%) were described in the reports, 42 (33.3%) and 59 (47.0 %) were only considered partially, and 17 (13.5%) and 23 (18.0%) were not considered in the NICE and CONITEC reports, respectively. We identified a relatively low agreement between the Brazilian agency with the English agency in the reports issued for rare diseases. It remains to be seen whether the agencies are able to capture the various values ​​of these medicines, as well as manage uncertainties in the evaluations.

A avaliação de tecnologias em saúde (ATS), enquanto prática científica e tecnológica é, ao mesmo tempo, um desafio, a fim de determinar o valor das tecnologias a serem incorporadas. Este estudo teve como objetivo explorar e comparar os resultados e elementos técnicos das avaliações emitidas para doenças raras, entre a agência inglesa (NICE) e a brasileira (CONITEC). A primeira etapa do estudo envolveu a busca sistemática das avaliações no período de 2013 a 2019. Na segunda etapa, os relatórios foram analisados com base em: (i) revisão narrativa descritiva e (ii) cálculo da frequência absoluta e relativa de acordo com cada domínio e componente (elemento) aplicado do modelo da rede Europeia de ATS. O total de 24 medicamentos foram distintamente avaliados no período do estudo. Por meio de 126 questões (elementos) distribuídas entre nove domínios, a análise revelou que 67 (53,2%) e 44 (35,0%) estavam descritas nos relatórios, 42 (33,3%) e 59 (47,0%) foram consideradas apenas parcialmente e 17 (13,5%) e 23 (18,0%) não foram consideradas nos relatórios do NICE e da CONITEC, respectivamente. Foi constatado uma concordância relativamente baixa da agência brasileira em relação à inglesa nos relatórios emitidos para doenças raras. Permanece indeterminado se as agências são capazes de capturar os diversos valores desses medicamentos, bem como gerenciar as incertezas nas avaliações.

A Sociotechnical Approach to Analyze Pharmaceutical Policy and Services Management in Primary Health Care in a Brazilian Municipality.

The decentralization of the Brazilian health system required that municipalities took responsibility for the local Pharmaceutical Policy and Services (PPS) system. This article presents and analyses an innovative experience of diagnosis of municipal PPS as a sociotechnical system. We adopted a multi-methods approach and various data sources. Sociotechnical theory was the framework of the methodology of evaluation and design of systems, analyzing the External System (health system, stakeholders, financing) and Internal System (goals, management, workforce, infrastructure, processes, technology and culture). The "objective" component of the PPS system was identified as the central element. The lack of a unified objective and of a central coordination and unmanaged pharmaceutical services prevented integrated internal planning and planning with other sectors. Stakeholders and documents referred only to technical elements of the system: Infrastructure, technical process, and technology. The social components of the workforce and culture were not mentioned. The organizational culture established was the culture of isolation: "Each one does his own". The pharmacists working in the municipal health system did not know each other. There was no integration strategy between pharmacists and their work processes. Consequently, the municipal PPS had limited scope as a public policy. It had constrained the characteristics of PPS as a complex and open system. Understanding the municipal PPS as a sociotechnical system can push the development of a new level of policy and practice to ensure the population's right to the access to and rational use of medicines.

A Comprehensive Understanding of the Use of e-Learning in Continuing Education: Experiences of Pharmacists in a Public Health System.

INTRODUCTION: The health and education sectors have experienced rapid technological development. In this scenario, the use of Internet technology has grown as an option for the expansion of continuing education (CE), as it allows professionals to develop educational activities with flexibility, autonomy, and convenience. E-learning has gained popularity and currently, thousands of online courses are being offered. However, studies of e-learning in professional training have presented only a few specific foci of study. OBJECTIVE: to develop a comprehensive approach to understand both the experience and the complex scenario of the use of e-learning in the CE for pharmacists. METHOD: Field research in 10 Brazilian states through interviews and focus groups with alumni of a CE e-learning specialization course for pharmacists in public health. Data analysis used the model of socio-technical systems and was based on a framework with the components Objectives, People, Processes, Culture, Technology, Infrastructure, and Scenario. RESULTS: The People and Culture components indicated the assimilation and normalization of technologies in the educational process. Although the infrastructure (technical and organizational) was deficient in some regions, the Technology component suggested that the characteristics of the course design, associated with the personal characteristics of the students, provided ways to overcome obstacles. The objectives of the use of distance education seem to be related to the possibility of greater accessibility and autonomy. The Processes component, in turn, revealed the burden that a e-learning course puts on the pharmacist. CONCLUSION: E-learning proved to be useful to enable and expand access to education, providing pharmacists with an opportunity for CE. On the other hand, e-learning contributes to the normalization of the precarious working conditions of pharmacists, attributing to individuals the sole responsibility for the CE even in an institutional CE program, which results in work overload.

Impact of a Pharmacy Management Course for Pharmacists Working Within Brazil's Public Health System.

Objective. To assess the impact of a continuing education course that focused on the development of management competencies on pharmacists working in Brazil's public health system.Methods. A specialization blended in-service course (360 hours) entitled Pharmaceutical Service and Access to Medicine Management was offered to pharmacists working within the Brazilian public health system. Data on course outcomes were collected through individual interviews with pharmacists who worked in the Brazilian public health system, as well as from focus groups and records of researchers' observations. The analysis was based on models of learning and training evaluation theory.Results. The findings showed proximal outcomes on students' knowledge, skills, and attitudes; behavioral changes; and programmatic outcomes in the organization and management of health services, promoting the recognition and integration of the "pharmaceutical services division" - a dedicated sector within the health departments in municipalities and states. The inputs (course content, structure, and in-service hands-on activities) were directly linked to the outcomes reported by participants and helped them to overcome some of the barriers to using knowledge and skills in the workplace.Conclusion. A well-structured course including leaning activities to intervene in the workplace had a positive impact on pharmacists' behavior and contributed to the capacity building of the organizations in which they operate.

Management of the health workforce in facing COVID-19: disinformation and absences in Brazil's Public Policies.

The objective of this research was to analyse federal government interventions in crisis management and the consequences for health professionals. This is a documentary-type qualitative research. Brazilian Federal regulations referring to work and health education produced during the pandemic emergency of COVID-19, published from January 28 to June 2, 2020, were identified. Of the total of 845 documents, 62 were selected in accordance with the inclusion criteria and were then submitted to Thematic Content Analysis. The results and discussions were grouped into four categories:workforce management, workforce protection, workforce training and academic-workforce relationship. Absence of a federal coordinating actions and policies for desinformation were identified. This lacking mechanisms for coordination contributed decisively to the tragic epidemiological situation still underway, especially in terms of the exposure of health workers to the risk of contamination, revealed in the extremely high rates of professionals infected or killed by COVID-19 in Brazil and the failure to control the pandemic in the population.

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.

Attending a Blended In-Service Management Training in a Public Health System: Constraints and Opportunities for Pharmacists and Health Services.

Management and public health are important domains of competency for pharmacists. In about 90% of Brazilian health departments, pharmacists manage the selection and purchase of medicines. The Pharmaceutical Services and Access to Medicines Management Course (PSAMM) was offered to pharmacists working in the public health system. The aim of this study is to analyze the impacts of the course as perceived by the students (pharmacists). Two thousand five hundred pharmacists completed the course. It is a mixed-methods study, including subscribing forms (n = 2500), evaluation questionnaire (n = 1500), focus groups (n = 10), and semi-structured interviews (n = 31). Participants reported a high level of satisfaction with the course; they considered to have developed competencies related to leadership and management, competencies needed to enhance and sustain their practices in health services. Data analyses showed important barriers to complete the course: high course workload, poor quality of Internet access, lack of support from the health services. Participants highlighted crucial features of the course that helped them develop key competencies: practical in-service activities, useful and realistic contents, tutoring. These features helped participants overcome some important constraints described by them. The educational model described in this study was perceived as having a long-term impact on their behaviors and management practices in health services.

Teaching and Learning Pharmacy Services: A Teaching Method for Developing Competencies for Patient-Centered Care Through Experiential Learning in a Real Workplace.

INTRODUCTION: Considering the transformation process that has been occurring in pharmacy education and the urgent need to address social health needs, proposals of teaching methods for the development of competences and skills in patient-centered care have become an issue worth discussing. The study describes and discusses the method that has been used for developing of these competencies through experiential learning in a university pharmacy in Brazil. EDUCATIONAL ACTIVITY: The Teaching and Learning of Pharmacy Services (TLPS) method encompasses 2 components: theoretical-reflexive one (developing protocols covering the patient care process) and practical-reflexive one (using the protocols with real patients). TLPS connects the 2 components in a way to enable students to acquire and apply theoretical knowledge for a comprehensive assessment of the patients' needs and understand how clinical reasoning and decision-making take place. The assessment process is performed, by the supervisor, which evaluates the behaviors necessary for good professional performance. DISCUSSION: The active learning methodologies have been effectively used in the classroom as a way to stimulate critical thinking, problem-solving, and clinical reasoning. However, experiential learning is considered a central point in the learning process and essential for knowledge building. Thus, the method herein described is shown as an innovative tool to promote self-learning, consolidation and interrelation of the acquired knowledge, easier identification of patients' needs, normalization of behaviors, and improvement in the quality of care.

Integra Project: strengthening social participation in the agenda of health policies, services, and technologies. / Projeto Integra: fortalecimento da participação social na agenda das políticas, serviços e tecnologias em saúde.

The 16th National Health Conference illustrated the interest of health councils to intervene in public policies in order to guarantee the right to health technologies. The INTEGRA project (Integration of policies for Health Surveillance, Pharmaceutical Care, Science, Technology, and Innovation in Health) is a partnership among the National Health Council, the National School of Pharmacists, and the Oswaldo Cruz Foundation (Fiocruz), with support from the Pan American Health Organization (PAHO), with the goal of strengthening participation and social engagement in the theme, as well as the integration of health policies and practices within different sectors of society (social movements, health councils, and health professionals), with the various stages related to the access to medicines (research, incorporation, national production, and services) being the main theme in the context of the COVID-19 pandemic. It seeks to offer training for leadership groups in the health regions and activities with a broad national and political scope, and it hopes to establish an intersectorial and integrated network of leaders capable of acting collaboratively to defend the development of science, public policies, national sovereignty, and social control of health.

A 16ª Conferência Nacional de Saúde demonstrou o interesse do controle social em intervir sobre as políticas públicas a fim de garantir o direito às tecnologias de saúde. O projeto Integra - Integração das Políticas de Vigilância em Saúde, Assistência Farmacêutica, Ciência, Tecnologia e Inovação em Saúde -, nasce da parceria entre o Conselho Nacional de Saúde, a Escola Nacional dos Farmacêuticos e a Fundação Oswaldo Cruz (Fiocruz), com apoio da Organização Pan-Americana de Saúde (OPAS) com objetivo de fortalecimento da participação e engajamento social na temática e a integração das políticas e práticas de saúde em diferentes setores da sociedade (movimentos sociais, controle social e profissionais de saúde), tendo as diversas etapas relacionadas ao acesso aos medicamentos (pesquisa, incorporação, produção nacional e serviços) como mote principal, no cenário da pandemia de COVID-19. Oferta-se, neste projeto, capacitação para grupos de lideranças nas regiões de saúde e atividades de grande abrangência nacional e política. Espera-se alcançar o estabelecimento de uma rede intersetorial, integrada de lideranças capazes de atuar colaborativamente para a defesa do desenvolvimento da ciência, das políticas públicas, da soberania nacional e do controle social da saúde.