Pharmaceutical policies for gaining access to high-priced medicines: a comparative analysis between England and Brazil / Políticas farmacêuticas para acesso a medicamentos de alto preço: uma análise comparativa entre Inglaterra e Brasil

ABSTRACT Although the National Health Service (NHS) and the Unified Health System (SUS) are systems with similar universal principles, they can show different political measure patterns in the pharmaceutical field. This paper aimed to provide a comparative analysis of pharmaceutical policies highlighting strategies to guarantee access and sustainability to High-Price Medicines (HPMs) in Brazil and England. We performed an integrative literature review in electronic databases, supplemented by grey literature searched on governmental platforms (laws, decrees, ordinances, and resolutions). A total of Forty-seven articles and seven policies were selected and categorized for analysis. The results showed that both countries apply distinct policies to ensure access to HPMs, among them, policies to define price and reimbursement and actions to regulate the use inside the system. Also, these countries apply distinct policies to their sustainability as local partnerships for product development in Brazil and confidential managed agreements with multinational industries in the England. In conclusion, despite similarities in principles, these countries have been proposing and applying distinct pharmaceutical policies to maintain access and ensure the sustainability of their health systems.

RESUMO Embora o National Health Service (NHS) e o Sistema Único de Saúde (SUS) sejam sistemas com princípios universais semelhantes, diferentes políticas no campo farmacêutico podem coexistir. O objetivo deste artigo foi fornecer uma análise comparativa destacando estratégias para garantir o acesso e a sustentabilidade a Medicamentos de Alto Preço (MAP) no Brasil e na Inglaterra. Foi realizada uma revisão integrativa da literatura em bases de dados eletrônicas, complementada por literatura cinzenta pesquisada em plataformas governamentais (leis, decretos, portarias e resoluções). Um total de 47 artigos e 7 políticas foram selecionados e categorizadas para análise. Os resultados demostraram que ambos os países aplicam distintas políticas para garantir o acesso aos MAP, entre elas, políticas para definição de preço e reembolso e ações para regular a utilização destes medicamentos dentro do sistema. Além disso, os países aplicam políticas distintas à sua própria sustentabilidade como as parcerias para o desenvolvimento produtivo local no Brasil e acordos confidenciais com indústrias multinacionais na Inglaterra. Em conclusão, apesar das semelhanças nos princípios, estes países têm proposto e aplicado políticas farmacêuticas distintas para manter o acesso e a sustentabilidade de seus sistemas de saúde.

Health regulation and technological development: innovative strategies for accessing medicines in the SUS. / Regulação sanitária e desenvolvimento tecnológico: estratégias inovadoras para o acesso a medicamentos no SUS.

Regulatory science involves articulating knowledge that can establish the scientific bases for the definition of adequate and efficient regulatory mechanisms and practices. The interfaces between systemic and sectoral health and technological development policies were studied based on documentary analysis, especially from the National Pharmaceutical Policy (PNAF), with impacts on health regulation and stimulating the production of medicines of interest to the Unified Health System (SUS). The initiatives for the nationalized production of ARV "Efavirenz", which was the subject of a compulsory license in 2007, and the establishment of Partnerships for Productive Development (PDP), contributed to defining innovative regulatory frameworks and practices, emphasizing the Regulatory Technical Committees (CTR) for monitoring the internalization of technologies and health registration of the resulting products. The permeation capacity of the principles and strategic axes of the PNAF was identified in the sectoral policies that were analyzed. As of 2014, no macro or sectoral policies on expanding access to medicines in the SUS with impacts on regulations were identified.

A ciência regulatória é o campo de articulação de saberes que visa estabelecer as bases científicas para a definição de mecanismos e práticas regulatórias adequadas e eficientes. Com base na análise documental, foram estudadas as interfaces entre as políticas sistêmicas e setoriais no campo do desenvolvimento tecnológico e da saúde, especialmente a partir da Política Nacional de Assistência Farmacêutica (PNAF), com impactos no campo regulatório sanitário e no estímulo à produção de medicamentos de interesse do Sistema Único de Saúde (SUS). As iniciativas para a produção nacionalizada do medicamento antirretroviral "efavirenz", objeto de licença compulsória em 2007, bem como o estabelecimento das Parcerias para o Desenvolvimento Produtivo (PDP), contribuíram para a definição de marcos e práticas regulatórias inovadoras, com destaque para os Comitês Técnico-Regulatórios (CTR) de acompanhamento das internalizações das tecnologias e registro sanitário dos produtos resultantes. Foi identificada a capacidade de permeação dos princípios e eixos estratégicos da PNAF no campo das políticas setoriais analisadas. A partir de 2014 não foram identificadas de macropolíticas ou políticas setoriais relacionadas à ampliação do acesso aos medicamentos no SUS com impactos no campo regulatório.

Regulação sanitária e desenvolvimento tecnológico: estratégias inovadoras para o acesso a medicamentos no SUS / Health regulation and technological development: innovative strategies for accessing medicines in the SUS

Resumo A ciência regulatória é o campo de articulação de saberes que visa estabelecer as bases científicas para a definição de mecanismos e práticas regulatórias adequadas e eficientes. Com base na análise documental, foram estudadas as interfaces entre as políticas sistêmicas e setoriais no campo do desenvolvimento tecnológico e da saúde, especialmente a partir da Política Nacional de Assistência Farmacêutica (PNAF), com impactos no campo regulatório sanitário e no estímulo à produção de medicamentos de interesse do Sistema Único de Saúde (SUS). As iniciativas para a produção nacionalizada do medicamento antirretroviral "efavirenz", objeto de licença compulsória em 2007, bem como o estabelecimento das Parcerias para o Desenvolvimento Produtivo (PDP), contribuíram para a definição de marcos e práticas regulatórias inovadoras, com destaque para os Comitês Técnico-Regulatórios (CTR) de acompanhamento das internalizações das tecnologias e registro sanitário dos produtos resultantes. Foi identificada a capacidade de permeação dos princípios e eixos estratégicos da PNAF no campo das políticas setoriais analisadas. A partir de 2014 não foram identificadas de macropolíticas ou políticas setoriais relacionadas à ampliação do acesso aos medicamentos no SUS com impactos no campo regulatório.

Abstract Regulatory science involves articulating knowledge that can establish the scientific bases for the definition of adequate and efficient regulatory mechanisms and practices. The interfaces between systemic and sectoral health and technological development policies were studied based on documentary analysis, especially from the National Pharmaceutical Policy (PNAF), with impacts on health regulation and stimulating the production of medicines of interest to the Unified Health System (SUS). The initiatives for the nationalized production of ARV "Efavirenz", which was the subject of a compulsory license in 2007, and the establishment of Partnerships for Productive Development (PDP), contributed to defining innovative regulatory frameworks and practices, emphasizing the Regulatory Technical Committees (CTR) for monitoring the internalization of technologies and health registration of the resulting products. The permeation capacity of the principles and strategic axes of the PNAF was identified in the sectoral policies that were analyzed. As of 2014, no macro or sectoral policies on expanding access to medicines in the SUS with impacts on regulations were identified.

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.

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.

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.

Analysis of a Blended, In-Service, Continuing Education Course in a Public Health System: Lessons for Education Providers and Healthcare Managers.

Introduction: To train pharmacists working in the public health system, the Brazilian Ministry of Health developed a specialization course called Pharmaceutical Service and Access to Medicine Management (PSAMM) between 2010 and 2016. The course was free of charge and used e-learning as its main approach. In the end, 2,500 pharmacists were trained. The purpose of this study was to identify and analyze the strengths, weaknesses, opportunities, and threats of an in-service and e-learning course for pharmacists working in a public health system. Materials and Methods: Three workshops involving 67 participants were conducted at the conclusion of the course to analyze the perspective of the PSAMM course's faculty (tutors, regional coordinators, professors, and management committee) and students (pharmacists). Strengths, weaknesses, opportunities, and threats analysis and qualitative analysis methods were used. Results and Discussion: The strength dimension had the greatest number of items. The qualitative analysis resulted in six categories: the category "E-learning in continuing education" had the most cited items. Internal elements such as in-service hands-on activities directly related to the professionals' roles, course contents, faculty, and the methods to offer the course (the mixed methods and materials) were positively assessed. Nonetheless, external elements were considered critical for the course's outcomes such as investments in the infrastructure of pharmaceutical services, access to the internet, local managers' support for continuing education and innovation implementation, practice of interprofessional collaboration, and political stability. The continuing education course in the public health system was affected by internal elements such as its project and structure as well as external elements such as the sociopolitical scenario. Continuing education investment must be accompanied by infrastructure investment and coordination of services.

The different clinical guideline standards in Brazil: High cost treatment diseases versus poverty-related diseases.

Each year, evidence-based clinical guidelines gain more space in the health professionals' practice and in services organization. Due to the scarcity of scientific publications focused on diseases of poverty, the development of well-founded clinical guidelines becomes more and more important. In view of that, this paper aims to evaluate the quality of Brazilian guidelines for those diseases. The AGREE II method was used to evaluate 16 guidelines for poverty-related diseases (PRD) and 16 guidelines for global diseases whose treatment require high-cost technologies (HCD), with the ultimate aim of comparing the results. It was found that, in general, the guideline development quality standard is higher for the HCD guidelines than for the PRD guidelines, with emphasis on the "rigour of development" (48% and 7%) and "editorial independence" (43% and 1%) domains, respectively, which had the greatest discrepancies. The HCD guidelines showed results close to or above international averages, whereas the PRD guidelines showed lower results in the 6 domains evaluated. It can be concluded that clinical protocol development priorities need some redirecting in order to qualify the guidelines that define the healthcare organization and the care of vulnerable populations.

Diretrizes gerais para uma política nacional de inclusão das ações de diagnóstico no processo de atenção à saúde: a atenção em análises clínicas e toxicológicas como um dos eixos estruturantes / General guidelines for a national policy for the inclusion of diagnosis actions in the process of health care: attention in clinical and toxicological analysis as one of the structuring axes

As políticas públicas voltadas para atenção à saúde dependem da participação e envolvimento político, exigem o aprimoramento científico e técnico, além de ferramentas adequadas para a gestão, incorporação de tecnologias e a aplicação de estratégias para a superação das fragmentações dos serviços, na perspectiva concreta das efetivas universalidade e integralidade das ações de saúde, com equidade. O objetivo deste documento foi propor diretrizes de uma política voltada às análises clínicas e toxicológicas alinhada com as atuais iniciativas do Ministério da Saúde. Foi utilizada como metodologia a análise das discussões e demandas extraídas dos fóruns das Comissões de Análises Clínicas dos Conselhos de Farmácia do Sul do Brasil, tendo como pressupostos as questões conceituais e estratégicas elencadas no presente documento. O resultado deste documento gerou de um conjunto de diretrizes gerais e seis eixos estratégicos, quais sejam, os conceitos fundamentais, o acesso e segurança do paciente, o financiamento e estruturação da rede, a incorporação de tecnologias, o reconhecimento do trabalho na atenção em análises clínicas e a regulação dos serviços. Espera-se que estes eixos possam colaborar com as iniciativas em andamento no Ministério da Saúde, especialmente no tocante à estruturação da rede de diagnóstico e suas interfaces com todas as ações de atenção e cuidado em saúde, incluindo aqueles de caráter complementar às ações desenvolvidas no contexto dos serviços públicos de atenção.

Public policies for health care depend on the participation and political involvement, requiring scientific and technical improvement, as well as appropriate tools for management, incorporating technologies and implementation strategies to overcome the fragmentation of services with a concrete view of the actual universality and comprehensiveness of health actions with equity. The purpose of this study is to propose guidelines for a policy aimed at clinical and toxicological analysis in line with the current Ministry of Health initiatives. It used the analysis of discussions and demands extracted from the forums of Clinical Analysis Committees of South Pharmacy Councils Brazil as its methodology, taking the conceptual and strategic issues listed in this document as assumptions. The result of this document has generated a set of general guidelines and six strategic axes, namely, the fundamental concepts, patient access and safety, network financing and structuring, technology incorporation, work recognition in clinical analysis care, and service regulation. It is expected that these axes can collaborate with ongoing initiatives at the Ministry of Health, especially regarding the structure of the diagnostic network and its interfaces with all care and health care actions, including those of complementary character to the actions developed in the context of public health care services.

Current development in regulation of similar biotherapeutic products in Brazil.

Because of the recent expiry of a large number of patents on the originator biological products, interest in the production and marketing of similar biotherapeutic products in Brazil has been increasing. The national producers have significant interest in this market and have been making a large amount of investments in these kinds of products. Since biotherapeutic products consume a large amount of the government health budget, the Brazilian government also has a big interest in the possibility that more affordable biotherapeutic products could be introduced into the market to improve access, but always is concerned with the quality, safety and efficacy of these products Accordingly, it was necessary to review the biological product regulations in Brazil and to establish specific pathways to license similar biotherapeutic products. The new Brazilian regulations, Resolution no. 55/2010, are based on different regulations and guidelines from around the world, including the WHO SBP Guidelines. They follow the same scientific principles as the WHO Guidelines but also have some differences which are due to specific country needs.

Avaliacao de tecnicas para determinacao quantitativa de alguns Benzimidazois em formas farmaceuticas solidas / Estimate of techniques for quantitative determination of some Benzimodozols in solid pharmaceutic forms

Dois farmacos representativos do grupo dos benzimidazois-mebendazol e tiabendazol foram doseados diretamente em comprimidos de especialidades farmaceuticas distribuidas por laboratorios nacionais e transnacionais para serem utilizados na terapia anti-helmintica. A fim de detectar qual o componente do excipiente que interferia na determinacao quantitativa direta, esses resultados foram comparados com o doseamento em formulacoes simuladas. Os resultados demonstraram que a polivilpirrolidona interfere na determinacao quantitativa direta nas especialidades farmaceuticas que contem triabendazol e nao nas que contem mebendazol.

Producao cientifica dos docentes do Centro de Ciencias da Saude da Universidade Federal de Santa Catarina / Scientific production by Faculty members of the School of Health Sciences of the Federal University of Santa Catarina

Trata-se de um estudo exploratorio descritivo com o objetivo de levantar a situacao da producao cientifica dos docentes do Centro de Ciencias da Saude (CCS) nos ultimos 20 anos. O estudo foi realizado com 193 professores dos 9 (nove) departamentos do Centro de Ciencias da Saude que aceitaram participar do estudo. Os dados foram levantados atraves de um formulario e para sua interpretacao utilizou-se estatistica descritiva. Os resultados indicaram que os 193 professores do estudo apresentaram um total de 3.486 producoes cientificas, ou seja, 0,9 producoes/professor/ano. Dos apresentados 147 sao teses; o veiculo mais utilizado para publicacao foi a revista nacional com 793 publicacoes, ou seja, 0,3 publicacao/professor/ano. Os eventos cientificos foram os meios mais utilizados para a divulgacao dos trabalhos, num total de 1.756 ou 0,4 apresentacoes/professor/ano. As publicacoes em andamento foram tambem levantadas. Foram encontrados 295 trabalhos em andamento, dos quais 173 sao pesquisas. O maior numero de producoes pertence aos professores com maior titulacao e que estao nas categorias funcionais mais elevadas. Os departamentos do estudo nao possuem linhas de pesquisas estabelecidas. Constatou-se que apenas os Cursos de Pos-graduacao/Mestrado- em Enfermagem e Odontologia possuem linhas de pesquisa definidas. Os dados indicaram a falta de diretrizes que orientam a producao cientifica do CCS.

Analise comparativa das informacoes apresentadas nas bulas de medicamentos antianemicos contendo sulfato ferroso / Comparative analysis of the label on antianemic medicine containing ferrous sulfate

Procedeu-se a valiacao das informacoes contidas nas bulas de cinco medicamentos contendo sulfato ferroso, produzidos por diferentes laboratorios, sendo dois de capital transnacional e tres de capital nacional. Tal avaliacao foi executada a luz da literatura especializada e da legislacao vigente, tendo como objetivos a verificacao de adequacao das informacoes, bem como fornecer subsidios para a discussao dos criterios adotados para a liberacao de medicamentos ao consumidor, no tocante as informacoes que os acompanham. Os laboratorios de capital transnacional apresentaram uma media de 51,4 por cento do total das informacoes necessarias, enquanto que os laboratorios de capital nacional apresentaram a media de 46,4 por cento. A maior defasagem de informacoes verificou-se nos topicos relativos as contraindicacoes, precaucoes, interacoes medicamentosas, reacoes adversas, conduta nos casos de super-dosagem e informacoes genericas direcionadas ao paciente. Conclui-se que as bulas analisadas apresentaram-se inadequadas a legislacao vigente, omitindo informacoes fundamentais para os profissionais da saude e para o consumidor, tanto no aspecto qualitativo como quantitativo.

Investigaçäo farmacológica do extrato aquoso de folhas/caules de Achyrocline satureioides (LAM.) DC., compositae (Marcela) / Pharmacological research of aquous extracts from leaves/stems of Achyrocline satureioides (LAM) DC., composital (Marcela)

Achyrocline satureioides (Lam.) DC., Compositae, vulgarmente conhecida como "marcela", é uma planta amplamente utilizada em medicina popular no sul do Brasil por suas propriedades digestivas, colagogas, antiespasmódicas, carminativas, eupépticas e emenagogas. O presente trabalho foi desenvolvido com o objetivo de analisar o extrato bruto das folhas/caules da A. satureioides (Lam.) DC., em diversos modelos experimentais. Os resultados obtidos evidenciam que o extrato aquoso das folhas/caules de A. satureioides (Lam.) DC. possui atividade colinolítica e miorrelaxante. Além disso, sugerem um efeito sedativo central quando testado nas doses de 250 e 500 mg/kg, via oral e i.p. Em conjunto, os resultados obtidos justificam o emprego do infuso de folhas/caules da "marcela" pela medicina popular