Políticas farmacêuticas: fatos políticos produzidos pelo Legislativo Federal entre 2016 e 2020 / Pharmaceutical policies: political facts produced by the Federal Legislative Branch between 2016 and 2020

RESUMO O estudo tem o objetivo de analisar fatos políticos produzidos pelo Poder Legislativo Federal com relação às políticas farmacêuticas no período de 2016 a 2020.Trata-se de um estudo explicativo, fundamentado em pesquisa documental, utilizando como fontes de dados os sites da Câmara dos Deputados e do Senado Federal, com o termo de busca 'medicamento'. Foram incluídos quatro tipos de documentos (projetos de lei, projetos de lei complementar, medidas provisórias e propostas de Emenda à Constituição) referentes às políticas farmacêuticas, originadas no período de janeiro de 2016 a dezembro de 2020. A busca foi realizada por dois revisores, obtendo-se um total de 330 atos, organizados por meio da técnica de análise de conteúdo, em três categorias (assistência farmacêutica, regulação farmacêutica e controle sanitário de medicamentos), das quais analisou-se um fato político de cada uma. O Legislativo atuou de forma expressiva sobre as políticas farmacêuticas no período estudado, produzindo fatos políticos com interação de diferentes atores e que impactam no acesso a medicamentos e em seu uso racional.

ABSTRACT The study aimed to analyze the performance of the Federal Legislative Branch in relation to pharmaceutical policies in the period from 2016 to 2020. This is an explanatory study, based on documentary research, using as data sources the websites of the House of Representatives and the Federal Senate, with the search term 'medicamento'. Four types of documents (bills, supplementary bills, provisional measures and proposed amendments to the Constitution) were included, referring to pharmaceutical policies, originated from January 2016 to December 2020. The search was performed by two reviewers, obtaining a total of 330 acts, organized, through the content analysis technique, into three categories (pharmaceutical assistance, pharmaceutical regulation and health control of medicines), of which one political fact from each was analyzed. The Legislative acted in an expressive way on pharmaceutical policies in the studied period, producing political facts with the interaction of different actors and that impact on access to medicines and on their rational use.

Validation of a new tool for evaluating subjects' satisfaction with medicine package leaflets: a cross-sectional descriptive study

ABSTRACT BACKGROUND: Package leaflets of medicines need to be intelligible, but tools for their evaluation are scarce. OBJECTIVE: To validate a new tool for assessing subjects' satisfaction with medicine package leaflets (LiS-RPL). DESIGN AND SETTING: Cross-sectional descriptive study conducted in two regions of Portugal (Lisbon and Centre). METHODS: 503 participants (53.1% male) were selected according to convenience and homogenously distributed into three groups: 1 to 6; 7 to 12; and > 12 years of schooling. LiS-RPL was developed based on international regulation guidelines and was initially composed of 14 items. Twelve package leaflets were tested. Dimensionality calculations included: exploratory factor analysis and minimum rank factor analysis; Kaiser-Meyer-Olkin index and Bartlett's sphericity test to assess matrix adequacy for exploratory factor analysis; exploratory bifactor analysis with Schmid-Leiman solution to detect possible existence of a broad second-order factor; and Bentler's Simplicity Index and Loading Simplicity Index to assess factor simplicity. Diverse coefficients were calculated to assess reliability. RESULTS: Minimum rank factor analysis detected a two-factor or single-factor structure. Exploratory factor analysis with 12 items showed a two-factor structure, explaining 69.11% of the variance. These items were strongly correlated with each other (r = 0.80). Schmid-Leiman: all items seemed to represent the general factor (loadings above 0.50), which was 76.4% of the extracted variance. Simplicity indices were good (percentile 99): Bentler's Simplicity Index of 0.99 and Loading Simplicity Index of 0.48. Internal consistency indexes indicated good reliability. LiS-RPL was shown to be homogenous. CONCLUSION: LiS-RPL is a validated tool for evaluating subjects' satisfaction with medicine package leaflets.

Establishing a regulatory value chain model: An innovative approach to strengthening medicines regulatory systems in resource-constrained settings / Establecimiento de un modelo de cadena de valor reglamentaria: un enfoque innovador para fortalecer los sistemas de reglamentación farmacéutica en entornos de escasos recursos

ABSTRACT Medicines Regulatory Authorities (MRAs) are an essential part of national health systems and are charged with protecting and promoting public health through regulation of medicines. However, MRAs in resource-constrained settings often struggle to provide effective oversight of market entry and use of health commodities. This paper proposes a regulatory value chain model (RVCM) that policymakers and regulators can use as a conceptual framework to guide investments aimed at strengthening regulatory systems. The RVCM incorporates nine core functions of MRAs into five modules: (i) clear guidelines and requirements; (ii) control of clinical trials; (iii) market authorization of medical products; (iv) pre-market quality control; and (v) post-market activities. Application of the RVCM allows national stakeholders to identify and prioritize investments according to where they can add the most value to the regulatory process. Depending on the economy, capacity, and needs of a country, some functions can be elevated to a regional or supranational level, while others can be maintained at the national level. In contrast to a "one size fits all" approach to regulation in which each country manages the full regulatory process at the national level, the RVCM encourages leveraging the expertise and capabilities of other MRAs where shared processes strengthen regulation. This value chain approach provides a framework for policymakers to maximize investment impact while striving to reach the goal of safe, affordable, and rapidly accessible medicines for all.(AU)

RESUMEN Los organismos de reglamentación farmacéutica son parte esencial de los sistemas nacionales de salud y se encargan de proteger y promover la salud pública mediante la reglamentación en torno a los medicamentos. Sin embargo, en lugares con pocos recursos, estos organismos suelen tener dificultad para supervisar eficazmente la entrada en el mercado y el uso de los productos sanitarios básicos. En el presente artículo se propone un modelo de cadena de valor reglamentaria (MCVR) que los responsables de las políticas y de la reglamentación pueden usar como marco conceptual para guiar las inversiones dirigidas a fortalecer los sistemas reglamentarios. El modelo incorpora en cinco módulos nueve funciones básicas de los organismos de reglamentación farmacéutica: (i) directrices y requisitos inequívocos; (ii) el control de los ensayos clínicos; (iii) la autorización de la comercialización de los productos médicos; (iv) el control de calidad antes de la comercialización; y (v) las actividades posteriores a esta. La aplicación del MCVR les permite a los interesados directos en los países determinar qué inversiones hacen falta y darles la prioridad debida teniendo presente dónde contribuirían en mayor medida a realzar el valor del proceso reglamentario. Si lo permiten la economía, la capacidad y las necesidades de un país, ciertas funciones pueden extenderse al nivel regional o supranacional, mientras que otras pueden seguir siendo nacionales. A diferencia de un método único para todos los casos, en el que cada país administra todo el proceso reglamentario en el nivel nacional, el MCVR promueve el aprovechamiento de la pericia y capacidades de otros organismos de reglamentación farmacéutica en áreas donde los procesos comunes fortalecen la reglamentación. Este método de la cadena de valor les proporciona a los formuladores de las políticas un marco para potenciar al máximo el efecto de las inversiones a la vez que se esfuerzan por lograr el objetivo de poner al alcance de todos medicamentos inocuos, asequibles y rápidamente accesibles.(AU)

Avaliação do conhecimento e das condutas dos farmacêuticos, responsáveis técnicos por drogarias / Assessment of knowledge and behavior of pharmacists with technical responsibility for drugstores

Através deste estudo, avaliou-se o nível de conhecimento e conduta dos farmacêuticos, responsáveis técnicos (RT) em drogarias, quanto a alguns aspectos da legislação farmacêutica e sanitária. Foram entrevistados 45 RT em 2007, sendo que 19 desconheciam a definição dos medicamentos de referência, 21 do genérico e 25 dosimilar. Todos sabiam da permissão de aplicação de medicamentos injetáveis. Porém, apenas dois sabiam da permissão da aplicação de penicilínicos, metade desconhecia que é permitido fracionar medicamentos fracionáveis em drogaria, 18 não sabiam dispensar corretamente uma prescrição pelo princípio ativo e 37 acreditavam que o farmacêutico pode intercambiar qualquer medicamento de marca pelo genérico. A maioria dos RT apresentou nível regular e insatisfatório de conduta e de conhecimento sobre a legislação profissional e sanitária, o que sinaliza um problema na formação acadêmica e de atualização permanente, podendo comprometer as diretrizes da política nacional de medicamentos.

This paper is a study of the level of knowledge and conduct of the legally responsible pharmacist-in-charge (PIC) at drugstores, regarding certain aspects of pharmaceutical and health legislation. In 2007, 45 PICs were interviewed, of whom 19 did not know the definition of original (innovative) branded drugs, 21 of generic drugs and 25 of similar branded drugs. All PICs knew that it is permitted to administer injectable drugs in the drugstore. However, only two knew that penicillins can be injected, half of them did not know that certain medicines can be fractionated in drugstores, 18 did not know how to dispense correctly a prescription for an active ingredient and 37 believed that the pharmacist can swap any brand name drug with its generic counterpart. Most PICs showed an unsatisfactory level of conduct and knowledge of the professional and health legislation, which points to problems in the undergraduate and in-service training of pharmacists, that could jeopardize the national drug policy guidelines.