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.

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.

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.

Patients in insulin analogues use via judicial litigation: do they use the Brazilian Public Health System (SUS)? / Pacientes em uso de análogos de insulina via ação judicial: eles utilizam o Sistema Único de Saúde (SUS)?

Abstract Background Studies show that among the drugs most commonly used in judicial litigation in Brazil, are those used to treat diabetes mellitus, especially insulin analogues. Objective Evaluate the use of the Unified Health System (SUS) by patients with type 1 diabetes mellitus (T1DM), who receive insulin analogues through judicial action, before and after this process. Method In a retrospective longitudinal observational study, secondary data was used from these patients in Minas Gerais, Brazil, in 2018. Socio-demographic information was collected and related to the follow-up of these patients in the SUS. The McNemar χ2 test was used to compare the proportions of the variables. Results Of the 89 patients analyzed, women (53.9%) were predominant. Most patients were aged between 20 and 39 years (52.8%), and more than half, 55.1%, use only a private health system. After the judicial action, there was a significant increase (p <0.05) in the number of patients who had consultations in primary health care (from 19.1% to 30.3%) and emergency medical appointments (from 1.1% to 9.0%). Conclusion It is observed that the majority of patients with T1DM via judicial action in the SUS are not monitored by this health system through examinations, consultations, and hospitalizations.

Resumo Introdução Estudos mostram que, dentre os medicamentos mais adquiridos via ação judicial, estão os utilizados para o tratamento do Diabetes Mellitus, especialmente os análogos de insulina. Objetivo Avaliar a utilização do Sistema Único de Saúde (SUS) pelos pacientes com Diabetes Mellitus tipo 1 (DM1), que recebem insulina por meio de judicialização, antes e após este processo. Método Em um estudo observacional longitudinal retrospectivo, foram utilizados dados secundários de pacientes com DM1, que adquiriram insulinas por processos judiciais em Divinópolis-MG, Brasil, em 2018. Foram coletadas informações sociodemográficas e referentes ao acompanhamento destes pacientes no SUS Realizou-se o teste χ2 de McNemar para a comparação das proporções das variáveis utilizadas para a avaliação do acompanhamento antes e após a judicialização. Resultados Dos 89 pacientes analisados, predominou-se o sexo feminino (53,9%), com idade entre 20 e 39 anos (52,8%). 55,1% destes utilizam apenas o sistema privado de saúde. Após a judicialização, houve um aumento significativo (p< 0,05) no número de pacientes que realizaram consultas na atenção primária à saúde (de 19,1% para 30,3%) e consultas médicas de emergência (de 1,1% para 9,0%). Conclusão A maioria dos pacientes com DM1 que judicializam medicamentos no SUS não são acompanhados por este sistema de saúde através de realização de exames, consultas e hospitalizações.

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.

Assistência Farmacêutica e governança global da saúde em tempos de Covid-19 / Pharmaceutical Services and global health governance in times of COVID-19

RESUMO Este ensaio aborda como e em que níveis a Assistência Farmacêutica é atravessada pela dinâmica da governança global da saúde, e como se relaciona com aspectos geopolíticos e socioeconômicos. Tenta-se ir além do acesso a medicamentos e produtos para saúde, abordando também o uso racional de medicamentos, seu impacto na resistência aos antimicrobianos e na saúde dos povos. Além disso, discute como a Assistência Farmacêutica pode ser vista nesse contexto.

ABSTRACT This essay addresses how and at what levels Pharmaceutical Services is affected by the dynamics of global health governance, and how it correlates with geopolitical and socioeconomic aspects. It attempts to go beyond access to medicines and health products, as well as to address the rational use of medicines, the impact in antimicrobial resistance and in people's health. Furthermore, it debates how Pharmaceutical Services can be seen in this context.

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.

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.

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.

Clinical pharmaceutical services of primary health care of the Federal District: A discussion based on the SWOT matrix

Abstract In the epistemic field, several studies demonstrate the importance of pharmaceutical services in health care networks. Nonetheless, literature still addresses the strengths and barriers present in the provision of these services in an incipient way. Thus, this study aimed to understand these contexts in the development of clinical services for primary health care in the Federal District, Brazil. A qualitative study adopted the technique of open-script interview, structured based on the logic of the SWOT matrix. Pharmacists reported weaknesses such as precariousness and scarcity of physical infrastructure, material, and human resources. As threats, they discussed the lack of social recognition, discontinuities of government actions, and lack of preparation of the pharmacist for the provision of clinical services. Regarding themes pertaining to the service's strengths and opportunities, the advances in propositions and executions of public policies, actions, and governmental programs that have expanded the pharmaceutical workforce in primary care and that are impelling the accomplishment of clinical services were listed. This study contributes to understanding the scenario of the development of clinical pharmaceutical services, and consequently provides subsidies for the actions of planning, evaluation and qualification of health services.

Clinical pharmaceutical services in primary health care of the Federal District: Performance frequency and conditioning factors

Abstract Pharmaceutical services correspond to a set of actions that aim to guarantee the integral access and rational use of drugs by the population. In this sense, this study aimed to identify the frequency and conditioning factors for clinical services of primary care in the Federal District, Brazil. A quantitative cross-sectional study was conducted, in which 34 pharmacists were interviewed. The most frequently developed clinical pharmaceutical services were dispensing, pharmaceutical guidance for users, and technical-pedagogical activities for the health team. There is a greater frequency of operation of clinical services by pharmacists working in pharmacies with physical infrastructure, with better levels of adequacy, greater support from management and health staff, and the inclusion in Family Health Support Nucleus activities. Although the clinical pharmaceutical services in primary care are incipient, the study raises important data for the reorientation and qualification of these actions.

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.

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.

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.

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.

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

Resumo 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.

Abstract 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.

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.