Resilience outcomes and associated factors among workers in community-based HIV care centres during the Covid-19 pandemic: A multi-country analysis from the EPIC program.

Introduction: Community health workers (CHW) were integral in the COVID-19 response, particularly concerning services for populations vulnerable to HIV. Little is known regarding the mental health of CHW during the COVID-19 crisis. The objective of this study was to study resilience of CHW working in HIV non-governmental organizations. Methods: An anonymous online, cross-sectional questionnaire was implemented during 2021 among CHW in Benin, Colombia, Guatemala, and Spain. Three scales were used to assess mental health: the 6-item Brief-Resilience Scale, the 9-item Patient Scale Questionnaire and the 7-item Generalized-Anxiety-Disorder scale. Logistic regression models were used to identify factors associated with "low" resilience vs "normal" or "high" resilience. Results: Among 295 respondents, the median standardized resilience score was 58.33 (IQR = [50.0-75.0], n = 267), 18.52 (IQR = [7.4-33.3], n = 282) for standardized depression score and 19.05 (IQR = [4.8-33.3], n = 274) for standardized anxiety score. Standardized resilience score was negatively correlated with standardized anxiety score (rho = -0.49, p < 0.001, n = 266) and standardized depression score (rho = -0.44, p < 0.001, n = 267). Conclusions: Normal or high level of resiliency in the HIV CHW were observed during the COVID-19 crisis. Self-efficacy, through COVID-19 prevention training, was a factor associated with resilience. Health policy must place CHW at the core of the healthcare system response to Covid-19 and to future health emergencies, as they ensure continuity of care for many diseases including HIV among vulnerable populations.

The state of the art of marine natural products in Colombia / El estado del arte de los productos naturales marinos en Colombia / O estado da arte dos produtos naturais marinhos na Colômbia

Abstract Marine Natural Products (MNPs) isolated from samples collected in Colombia have been an object of study since the early 1980's; however, this information is neither integrated nor compiled. This systematic review describes the articles published in scientific journals up to December 2019. 173 papers met the inclusion criteria of focusing on MNPs obtained from specimens collected from Colombian seas; all original papers written in English, Portuguese or Spanish. The selected papers were mostly authored by researchers from Colombian groups, with low interaction amongst themselves. 99.4% of the papers studied samples collected from the Caribbean Sea; 183 species were studied, mainly sponges and octocorals. In this study, 1,690 compounds (238 new ones) were reviewed, mainly diterpenes and sterol derivatives. Of the selected papers, 76.8% measured various biological activities, including antibiotic (34%) and anticancer (30%). These papers were published in 51 journals (74.6% were international). In conclusion, scientific work on natural marine products of Colombian origin has incremented over time. The most relevant opportunities to address and fill existing gaps comprise: exploring Pacific Ocean organisms and several of the misrepresented taxa; promoting strong interactions amongst the MNPs research groups, and accordingly with other areas of knowledge; and having the productive sector participate in MNPs research.

Resumen Los productos naturales marinos (PNM) aislados de muestras recolectadas en Colombia han sido estudiados desde principios de los años 1980, mas esta información no está integrada, ni recopilada. Esta revisión sistemática describe los artículos publicados hasta diciembre de 2019. 173 artículos cumplieron los criterios de inclusión de enfoque en PNM obtenidos de especímenes recolectados en mares colombianos; trabajos originales escritos en inglés, portugués o español. La mayoría de los artículos fueron escritos por investigadores de grupos colombianos, con poca interacción entre ellos. El 99,4% de los artículos estudiaban muestras recolectadas del mar Caribe. Se estudiaron 183 especies, especialmente esponjas y octocorales. Se identificaron 1690 compuestos (238 nuevos), principalmente diterpenos y derivados de esteroles. En el 76,8% de los artículos se midió alguna actividad biológica, principalmente antibiótica (34%) y anticancerígena (30%). Los artículos se publicaron en 51 revistas (74,6% internacionales). En conclusión, la investigación sobre los PNM de origen colombiano ha crecido con el tiempo. Algunas oportunidades para abordar las lagunas encontradas comprenden: explorar los organismos del océano Pacífico y los taxa poco estudiados; promover interacciones entre los grupos de investigación de los PNM y de otras áreas del conocimiento; e involucrar al sector productivo en la investigación de los PMN.

Resumo Os Produtos Naturais Marinhos (PNMs) isolados de amostras coletadas na Colômbia têm sido objeto de estudo desde a década de 1980; porém, esta informação não está integrada nem compilada. Esta revisão sistemática descreve os artigos publicados em revistas científicas até dezembro de 2019. 173 artigos atenderam aos critérios de inclusão de foco em PNMs obtidos de espécimes coletados em mares colombianos; artigos originais escritos em inglês, português ou espanhol. A maioria dos autores dos artigos eram pesquisadores de grupos colombianos, com baixa interação entre eles. 99,4% dos artigos estudavam amostras coletadas no Mar do Caribe. Foram estudadas 183 espécies, especialmente esponjas e octocorais. Nesta revisão, identificaram-se 1690 compostos (238 novos), principalmente diterpenos e derivados de esterol. 76,8% dos artigos mediram algumas atividades biológicas, incluindo antibiótica (34%) e anticancerígena (30%). Os artigos analisados foram publicados em 51 periódicos (74,6% internacionais). Em conclusão, o trabalho científico sobre PNM de origem colombiana cresceu ao longo do tempo. As oportunidades mais relevantes para preencher as lacunas existentes incluem: explorar organismos do Oceano Pacífico e os taxa pouco estudados; promover interação entre os grupos de pesquisa de PNMs e com grupos de outras áreas do conhecimento; e envolver o setor produtivo na pesquisa de PNMs.

Acciones judiciales que exigen tecnologías en salud en Brasil: una revisión sistemática de métodos mixtos / Lawsuits demanding health technologies in Brazil: a systematic review of mixed methods / Ações judiciais que demandam tecnologias em saúde no Brasil: uma revisão sistemática de métodos mistos

Objetivos: conocer el perfil y comprender el contexto descrito en las publicaciones sobre la judicialización del acceso a tecnologías en salud en Brasil. Metodología: revisión sistemática de métodos mixtos. Se consultaron 5 bases de datos y se incluyeron artículos que presentaran datos de procesos judiciales demandando tecnologías en salud del SUS en Brasil, o que analizaran este fenómeno, publicados en portugués, inglés y español, hasta 2019. La calidad metodológica fue evaluada con un enfoque convergente segregado. La caracterización de los datos de los estudios y el análisis e integración de la evidencia cuali-cuantitativa se realizó usando la síntesis realista. Resultados: 27 estudios fueron incluidos en la revisión. Se identificaron 76.666 procesos judiciales en que se solicitaba alguna tecnología en salud, en su mayoría medicamentos (65%); la mayoría de los procesos presentaron una representación jurídica privada (68%) y la mayoría de las acciones fue contra los estados (65%). Los enfoques de análisis de judicialización más frecuentes fueron Social Positivo (32%) y Normativo Negativo (32%), seguidos de 29% para el abordaje de Normativo Positivo. El abordaje Social Negativo (7%) fue el menos frecuente. Conclusiones: se identificó que existen evidencias cuantitativas que soportan las evidencias cualitativas. Estas demuestran que el desconocimiento del Poder Judicial sobre las políticas de salud lleva a un aumento de las desigualdades en salud; al fomento del paternalismo del Estado, así como que el aumento de acciones judiciales explica la necesidad de la búsqueda de alternativas para acceder a tecnologías en salud.

Objectives: to know the profile and understand the context described in publications on the judicialization of access to health technologies in Brazil. Methods: systematic review of mixed methods. Five databases were consulted, and articles were included that presented data from lawsuits demanding health technologies from the SUS in Brazil, or that analyzed this phenomenon, published in Portuguese, English and Spanish, until 2019. The methodological quality was evaluated using the convergent segregated approach. The characterization of data from the studies and the analysis and integration of qualitative-quantitative evidence were conducted through realistic synthesis. Results: 27 studies were included in the review. A total of 76,666 lawsuits were identified in which some health technology was requested, mainly medicines (65%); most lawsuits had private legal representation (68%) and most lawsuits were against the states (65%). The most frequent judicialization analysis approaches were Positive Social (32%) and Negative Normative (32%), followed by 29% for the Positive Normative approach. The Social Negative approach (7%) was the least frequent. Conclusions: it was identified that there is quantitative evidence that supports qualitative evidence. These demonstrate that the Judiciary's lack of knowledge about health policies leads to an increase in health inequalities; to the promotion of state paternalism, as well as the fact that the increase in lawsuits explains the need to seek alternatives for accessing health technologies.

Objetivos: conhecer o perfil e compreender o contexto descrito nas publicações sobre a judicialização do acesso às tecnologias em saúde no Brasil. Metodologia: Revisão sistemática de métodos mistos. Foram consultadas cinco bases de dados e incluídos artigos que apresentassem dados de processos judiciais demandando tecnologias em saúde do SUS no Brasil, ou que analisassem esse fenômeno, publicados em português, inglês e espanhol, até 2019. A qualidade metodológica foi avaliada com a abordagem convergente segregada. A caracterização dos dados dos estudos e a análise e integração das evidências qualitativos-quantitativas foram realizadas por meio da síntese realista. Resultados: 27 estudos foram incluídos na revisão. Foram identificados 76.666 processos judiciais em que foi solicitada alguma tecnologia em saúde, principalmente medicamentos (65%); a maioria dos processos apresentou representação legal privada (68%) e a maioria das ações foi contra os estados (65%). As abordagens de análise de judicialização mais frequentes foram Social Positiva (32%) e Normativa Negativa (32%), seguidas de 29% para a abordagem Normativa Positiva. A abordagem Social Negativa (7%) foi a menos frequente. Conclusões: identificou-se que há evidências quantitativas que sustentam as evidências qualitativas. Estes demonstram que o desconhecimento do Judiciário sobre as políticas de saúde leva ao aumento das desigualdades em saúde; à promoção do paternalismo estatal, bem como o fato de que o aumento das ações judiciais explica a necessidade de buscar alternativas de acesso às tecnologias em saúde.

Characterization of the import applications for unavailable vital medicines in 2016 and 2017 in Colombia. / Caracterización de las solicitudes de importación de medicamentos vitales no disponibles años 2016 y 2017 en Colombia.

This study analyzed the import applications for unavailable vital medicines (MVND) submitted to INVIMA and the records of MVND reimbursement requests submitted to the ADRES in the 2016-2017 period. Approximately 76% of the 2,321 MVND import applications were authorized. Eighty-eight applicants, 73 therapeutic subgroups, 195 active ingredients, and 368 diagnoses were identified. Most of the patients registered in the import applications (66%) are linked to the contributory regime, to a lesser extent to the subsidized regime and the Special or exceptional regimes. The total value of the reimbursement requests related to MVND granted by lawsuits, was USD 8,577,583, equivalent to 38,483 UPCs. The results showed that the implementation of Decree N° 481/2004 has ensured access to medicines for rare diseases. However, it is not alien to the structural inequality of access to health services and medicines of the Colombian Health System, which impacts public health and the allocated budget, either because of the high cost of importing MVND or because of the lack of MVND regulation within the national market.

En este estudio se analizaron las solicitudes de importación de Medicamentos vitales no disponibles (MVND) presentadas al INVIMA y los registros de solicitudes de recobros presentados en la ADRES por MVND, en el periodo 2016-2017. De las 2321 solicitudes de importación de MVND, el 76% fueron autorizadas. Se identificaron 88 solicitantes, 73 subgrupos terapéuticos y 195 principios activos, así como 368 diagnósticos. El 66% de los pacientes registrados en las solicitudes de importación se encuentran vinculados al régimen contributivo, en menor proporción al régimen subsidiado y al régimen especial o excepcional. En solicitudes de recobros asociados a MVND por vía judicial, se observó que, el monto solicitado por recobro fue de USD 8.577.583, equivalentes a 38483 UPCs. Los resultados mostraron que la implementación del decreto 481 de 2004 ha sido útil para garantizar el acceso a medicamentos para enfermedades raras, aunque no es ajena a la inequidad estructural de acceso a servicios de salud y medicamentos del SGSSS y que generan impacto, no solo en la salud pública, si no en el presupuesto asignado, bien sea por el alto costo que implica su importación o por la falta de regulación de estos dentro del mercado nacional.

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.

Vaccines in Brazil: historical analysis of the Sanitary registration and vaccine availability in the Brazilian Unified Health System. / Vacinas no Brasil: análise histórica do registro sanitário e a disponibilização no Sistema de Saúde.

Given the COVID-19 pandemic and the importance of public social protection policies, health issues, including immunizations, have gained prominence. This paper aims to analyze the dynamics of vaccine registration in Brazil and the vaccines made available through the National Immunization Program (PNI in Portuguese), with emphasis on the 2004-2018 vaccination schedule. This descriptive, exploratory, documentary research analyzed vaccine registration procedureswith the Brazilian Health Regulatory Agency (ANVISA, in Portuguese) and the incorporation of vaccine products into the PNI. The study drew on information from the national sanitary registration database, made available by ANVISA; a document analysis of official/normative publications; and data from published literature. The data shows the incorporation of vaccines into the PNI, evidencing that Brazil is a country with industrial potential for vaccine production but that is still focused on the transfer of technologies and in need of public attention and investments for developing new technologies as a way to ensure the sector's independence.

Com a pandemia da COVID-19 e a importância das políticas públicas de proteção social, questões sanitaristas incluindo as imunizações se tornaram destaque. O estudo tem o objetivo de analisar a dinâmica dos registros sanitários de vacinas no país e as vacinas disponibilizadas por meio do Programa Nacional de Imunização (PNI), com destaque para o calendário vacinal no período entre 2004 e 2018. Realizou-se um estudo descritivo, documental e exploratório dos processos de registro sanitário na Agência Nacional de Vigilância Sanitária (Anvisa) e a incorporação dos produtos no PNI. Como base da pesquisa foram utilizados o banco de dados de registro sanitário disponibilizado pela Anvisa, a análise documental de publicações oficiais/normativas e os dados da literatura. Os dados demonstram a incorporação das vacinas no PNI, assim como um país com potencial industrial para a produção das vacinas, no entanto ainda centrado na transferência de tecnologias, necessitando de investimentos e atenção pública no desenvolvimento de novas tecnologias, garantindo a independência do setor.

Caracterización de las solicitudes de importación de medicamentos vitales no disponibles años 2016 y 2017 en Colombia / Characterization of the import applications for unavailable vital medicines in 2016 and 2017 in Colombia

Resumen En este estudio se analizaron las solicitudes de importación de Medicamentos vitales no disponibles (MVND) presentadas al INVIMA y los registros de solicitudes de recobros presentados en la ADRES por MVND, en el periodo 2016-2017. De las 2321 solicitudes de importación de MVND, el 76% fueron autorizadas. Se identificaron 88 solicitantes, 73 subgrupos terapéuticos y 195 principios activos, así como 368 diagnósticos. El 66% de los pacientes registrados en las solicitudes de importación se encuentran vinculados al régimen contributivo, en menor proporción al régimen subsidiado y al régimen especial o excepcional. En solicitudes de recobros asociados a MVND por vía judicial, se observó que, el monto solicitado por recobro fue de USD 8.577.583, equivalentes a 38483 UPCs. Los resultados mostraron que la implementación del decreto 481 de 2004 ha sido útil para garantizar el acceso a medicamentos para enfermedades raras, aunque no es ajena a la inequidad estructural de acceso a servicios de salud y medicamentos del SGSSS y que generan impacto, no solo en la salud pública, si no en el presupuesto asignado, bien sea por el alto costo que implica su importación o por la falta de regulación de estos dentro del mercado nacional.

Abstract This study analyzed the import applications for unavailable vital medicines (MVND) submitted to INVIMA and the records of MVND reimbursement requests submitted to the ADRES in the 2016-2017 period. Approximately 76% of the 2,321 MVND import applications were authorized. Eighty-eight applicants, 73 therapeutic subgroups, 195 active ingredients, and 368 diagnoses were identified. Most of the patients registered in the import applications (66%) are linked to the contributory regime, to a lesser extent to the subsidized regime and the Special or exceptional regimes. The total value of the reimbursement requests related to MVND granted by lawsuits, was USD 8,577,583, equivalent to 38,483 UPCs. The results showed that the implementation of Decree N° 481/2004 has ensured access to medicines for rare diseases. However, it is not alien to the structural inequality of access to health services and medicines of the Colombian Health System, which impacts public health and the allocated budget, either because of the high cost of importing MVND or because of the lack of MVND regulation within the national market.

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

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

Abstract This case study aimed to characterize the Specialized Component of Pharmaceutical Services (CEAF) organization in four Brazilian states from diverse regions of the country. Data were collected with representatives of CEAF management from states in different regions, who answered a 21-question questionnaire on scope, organization, financing, hurdles, and facilitators. This information was complemented with data from national health surveys, DataSUS, the applied resources, and socioeconomic indicators. Differences were observed between states on issues such as the proportion of users and the decentralization of services. These characteristics seem to be related to the level of development concerning the socioeconomic indicators used. Advances in access to medicines were highlighted, despite the difficulties complying with the CEAF's objectives, such as insufficient resources, the qualification of human resources, and the provision of necessary visits and exams. The results point to advances, different forms of organization and highlight the need for more in-depth studies on the clinical and economic outcomes achieved as a strategy to outline solutions to achieve the comprehensive and equal care for users.

Vacinas no Brasil: análise histórica do registro sanitário e a disponibilização no Sistema de Saúde / Vaccines in Brazil: historical analysis of the Sanitary registration and vaccine availability in the Brazilian Unified Health System

Resumo Com a pandemia da COVID-19 e a importância das políticas públicas de proteção social, questões sanitaristas incluindo as imunizações se tornaram destaque. O estudo tem o objetivo de analisar a dinâmica dos registros sanitários de vacinas no país e as vacinas disponibilizadas por meio do Programa Nacional de Imunização (PNI), com destaque para o calendário vacinal no período entre 2004 e 2018. Realizou-se um estudo descritivo, documental e exploratório dos processos de registro sanitário na Agência Nacional de Vigilância Sanitária (Anvisa) e a incorporação dos produtos no PNI. Como base da pesquisa foram utilizados o banco de dados de registro sanitário disponibilizado pela Anvisa, a análise documental de publicações oficiais/normativas e os dados da literatura. Os dados demonstram a incorporação das vacinas no PNI, assim como um país com potencial industrial para a produção das vacinas, no entanto ainda centrado na transferência de tecnologias, necessitando de investimentos e atenção pública no desenvolvimento de novas tecnologias, garantindo a independência do setor.

Abstract Given the COVID-19 pandemic and the importance of public social protection policies, health issues, including immunizations, have gained prominence. This paper aims to analyze the dynamics of vaccine registration in Brazil and the vaccines made available through the National Immunization Program (PNI in Portuguese), with emphasis on the 2004-2018 vaccination schedule. This descriptive, exploratory, documentary research analyzed vaccine registration procedureswith the Brazilian Health Regulatory Agency (ANVISA, in Portuguese) and the incorporation of vaccine products into the PNI. The study drew on information from the national sanitary registration database, made available by ANVISA; a document analysis of official/normative publications; and data from published literature. The data shows the incorporation of vaccines into the PNI, evidencing that Brazil is a country with industrial potential for vaccine production but that is still focused on the transfer of technologies and in need of public attention and investments for developing new technologies as a way to ensure the sector's independence.

Estrategias para promover el acceso a medicamentos de interés en salud pública: revisión estructurada de la literatura / Strategies to promote access to medicines of interest in public health: structured review of the literature / Estratégias para promover o acesso a medicamentos de interesse em saúde pública: revisão estruturada da literatura

Resumen Objetivo: Identificar estrategias orientadas a favorecer el acceso a medicamentos de interés en salud pública, de alto costo o protegidos por patentes, posiblemente aplicables al contexto colombiano. Metodología: revisión estructurada en PubMed/Medline, utilizando los términos MeSH: "health services accessibility", "pharmaceutical preparations", "policy", con filtros para artículos publicados en inglés y español, entre 2012 y 2017. Se incluyeron aquellos con información sobre estrategias o políticas que favorecieran el acceso a medicamentos de interés en salud pública de alto costo o protegidos por patentes. Las estrategias identificadas fueron agrupadas acorde con las cinco dimensiones del acceso a la atención en salud y medicamentos definidas por la Organización Mundial de la Salud: disponibilidad, asequibilidad, accesibilidad, aceptabilidad y calidad. Resultados: Se identificaron 62 artículos, de los cuales se incluyeron 18 y se consideraron 5 referencias adicionales. Se reconocieron 30 estrategias, distribuidas y clasificadas según las dimensiones del acceso: disponibilidad y asequibilidad, 15; accesibilidad, 6; aceptabilidad, 6; calidad, 2; estrategia transversal, 1. Conclusiones: Se identificaron estrategias claves para favorecer el acceso a medicamentos de interés en salud pública de alto costo o protegidos por patentes, dentro de las que se encuentran las negociaciones centralizadas de precios; el apoyo financiero público para la investigación, desarrollo y producción nacional de medicamentos genéricos; la aplicación de las flexibilidades del acuerdo sobre los "Aspectos de los derechos de propiedad intelectual relacionados con el comercio" y la implementación de programas de asistencia.

Abstract Objective: To identify strategies aimed to improve access to medicines of interest in public health with high cost or protected with patents, possibly applicable to the Colombian contextTo identify strategies aimed at promoting access to high-cost or patent-protected medicines of interest in public health, possibly applicable to the Colombian context.. Methodology: structured review in PubMed/Medline, using the MeSH terms: "health services accessibility", "pharmaceutical preparations", "policy", with filters for articles published in English and Spanish, between 2012 and 2017. Studies with information on strategies or policies that favored access to high-cost or patent-protected drugs of interest in public health were included. The strategies identified were grouped according to the five dimensions of access to health care and medicines defined by the World Health Organization: availability, affordability, accessibility, acceptability and quality. Results: 62 articles were identified, of which 18 were included, and 5 additional references were considered. 30 strategies were recognised, distributed and classified according to the dimensions of access: availability and affordability, 15; accessibility, 6; acceptability, 6; quality, 2; cross-cutting strategy, 1. Conclusions: Key strategies were identified to favor access to high-cost or patent-protected medicines of interest in public health, including centralized price negotiations; public financial support for national research, development and production of generic medicines; the application of the flexibilities of the agreement on "Aspects of intellectual property rights related to trade" and the implementation of care programs.

Resumo Objetivo: Identificar estratégias destinadas a favorecer o acesso a medicamentos de interesse em saúde pública, de alto custo ou protegidos por patentes, possivelmente aplicáveis ao contexto colombiano. Metodologia: Revisão estruturada no PubMed/Medline, usando os termos MeSH: "health services accessibility", "pharmaceutical preparations", "policy", com filtros para artigos publicados em inglês e espanhol, entre 2012 e 2017. Foram incluídos aqueles com informações sobre estratégias ou políticas que favoreciam o acesso a medicamentos de interesse em saúde pública de alto custo ou protegidos por patentes. As estratégias identificadas foram agrupadas de acordo com as cinco dimensões de acesso aos cuidados de saúde e medicamentos definidas pela Organização Mundial da Saúde: disponibilidade, alcançabilidade, acessibilidade, aceitabilidade e qualidade. Resultados: Foram identificados 62 artigos, dos quais 18 foram incluídos e 5 referências adicionais foram consideradas. 30 estratégias foram identificadas, distribuídas e classificadas de acordo com as dimensões do acesso: disponibilidade e alcançabilidade, 15; acessibilidade, 6; aceitabilidade, 6; qualidade 2; estratégia transversal, 1. Conclusões: Foram identificadas estratégias-chave para favorecer o acesso a medicamentos de interesse em saúde pública de alto custo ou protegidos por patentes, dentro das quais estão as negociações centralizadas de preços; o apoio financeiro público à pesquisa, desenvolvimento e produção nacional de medicamentos genéricos; a aplicação das flexibilidades do acordo sobre "Aspectos dos direitos de propriedade intelectual relacionados ao comércio" e a implementação de programas de assistência.

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.

Drug utilization study of two generic antibiotics in a tertiary hospital in Bogotá

Introduction: The Colombian national pharmaceutical policy establishes as a strategy the generation of greater pharmaco-epidemiological research at the national level, especially in the case of antibiotic drugs. Objective: To provide local pharmaco-epidemiological evidence regarding the effectiveness, conditions of use and safety of generic meropenem and cefepime in a tertiary hospital in Bogotá. Materials and methods: We conducted a descriptive, longitudinal and retrospective drug utilization study. The data were collected from the medical histories of all the patients who had cefepime or meropenem prescribed. Results: We included 82 patients treated with cefepime and 91 treated with meropenem in the study. Most of the patients were in services different from the intensive care unit (taking cefepime: 59.8%, and meropenem: 52.7%). Only 21.9% of the patients treated with cefepime and 49% of those treated with meropenem were seen by an infectious disease specialist. The antibiogram was performed for 47% and 60% of the patients treated with cefepime and meropenem, respectively. The most frequent indication for cefepime were respiratory infections and for meropenem, genitourinary ones. Therapeutic success rates were 61.7% for cefepime and 63.0% for meropenem. Conclusions: This study contributes evidence regarding the therapeutic performance of two generic antibiotics used in tertiary hospitals. There were no reports of therapeutic failure during the study period. In the cases of non-response, pharmacokinetic alterations, unfavorable clinical conditions, and inappropriate choice of antimicrobial treatment were identified as frequent factors.

Utilización de dos antibióticos genéricos en un hospital de tercer nivel en Bogotá / Drug utilization study of two generic antibiotics in a tertiary hospital in Bogotá

Resumen Introducción. La política farmacéutica de Colombia establece la necesidad de intensificar la investigación en farmacoepidemiología a nivel nacional, especialmente en el caso de los antibióticos. Objetivo. Aportar información farmacoepidemiológica en cuanto a la efectividad, las condiciones de uso y la seguridad de la cefepima y el meropenem genéricos en un hospital de alta complejidad en Bogotá. Materiales y métodos. Se hizo un estudio descriptivo, longitudinal y retrospectivo sobre la utilización de estos medicamentos. Los datos se recolectaron de todas las historias clínicas en las cuales se registraba el uso de cefepima y meropenem. Resultados. Se incluyeron 82 pacientes tratados con cefepima y 91 con meropenem. La mayoría de ellos había estado internada en servicios diferentes a la unidad de cuidados intensivos (59,8 % con cefepima y 52,7 % con meropenem). El 21,9 % de los tratados con cefepima y el 49 % de los tratados con meropenem, tuvieron consulta con un infectólogo, en tanto que en 47 % de los primeros y en 78 % de los segundos, se hizo cultivo o antibiograma. Las condiciones más frecuentemente tratadas con cefepima fueron las infecciones de vías respiratorias (32,5 %) y, con meropenem, las infecciones genitourinarias (34,8 %). Las tasas de éxito terapéutico fueron de 61,7 % para la cefepima y de 63,0 % para el meropenem. Conclusiones. Este estudio aporta información sobre el desempeño terapéutico de dos antibióticos genéricos de uso hospitalario. No hubo reportes de falla terapéutica durante el periodo de estudio. En los casos en que no hubo respuesta al tratamiento, las causas frecuentes fueron las alteraciones farmacocinéticas, las condiciones clínicas desfavorables y la elección inadecuada del tratamiento antimicrobiano.

Abstract Introduction: The Colombian national pharmaceutical policy establishes as a strategy the generation of greater pharmaco-epidemiological research at the national level, especially in the case of antibiotic drugs. Objective: To provide local pharmaco-epidemiological evidence regarding the effectiveness, conditions of use and safety of generic meropenem and cefepime in a tertiary hospital in Bogotá. Materials and methods: We conducted a descriptive, longitudinal and retrospective drug utilization study. The data were collected from the medical histories of all the patients who had cefepime or meropenem prescribed. Results: We included 82 patients treated with cefepime and 91 treated with meropenem in the study. Most of the patients were in services different from the intensive care unit (taking cefepime: 59.8%, and meropenem: 52.7%). Only 21.9% of the patients treated with cefepime and 49% of those treated with meropenem were seen by an infectious disease specialist. The antibiogram was performed for 47% and 60% of the patients treated with cefepime and meropenem, respectively. The most frequent indication for cefepime were respiratory infections and for meropenem, genitourinary ones. Therapeutic success rates were 61.7% for cefepime and 63.0% for meropenem. Conclusions: This study contributes evidence regarding the therapeutic performance of two generic antibiotics used in tertiary hospitals. There were no reports of therapeutic failure during the study period. In the cases of non-response, pharmacokinetic alterations, unfavorable clinical conditions, and inappropriate choice of antimicrobial treatment were identified as frequent factors.

Perceptions of Individuals with Parkinson's Disease about Quality of Life / Percepciones de pacientes con enfermedad de Parkinson sobre la calidad de vida / Percepções de pacientes com doença de Parkinson sobre a qualidade de vida

Abstract Introduction: Parkinson's disease is a neurodegenerative disorder manifested by motor and non-motor symptoms that compromise patients' quality of life. The instrument used to assess Parkinson's disease patients' quality of life is the Parkinson's Disease Questionnaire (PDQ-39). This study aims to identify issues related to quality of life from the patients' perspective, compare the results obtained with the aspects included in the PDQ-39, and describe some strategies that patients have adopted to overcome difficulties. Materials and methods: This is a qualitative and descriptive study based on a focus group consisting of six patients. Data were analyzed using the content analysis method. Results: Aspects related to all PDQ-39 domains were mentioned by the patients, highlighting those related to limitations on their mobility and daily activities, as well as aspects related to their emotional wellbeing. The patients did not mention some aspects of mobility that are included in the PDQ-39, but limitations in the domain of emotional wellbeing that are included in the PDQ-39 were detected. In order to overcome difficulties, patients devise various strategies that require social support. Conclusion: Understanding and reflecting on Parkinson's disease patients' perceptions of their quality of life contributes to our understanding of the disease and stimulates proposals for adequate clinical interventions to provide comprehensive care. It is suggested that the PDQ-39 be reviewed and adapted to the current context, taking into account the most recent knowledge and technological advances related to Parkinson's disease.

Resumen Introducción: la enfermedad de Parkinson es una patología neurodegenerativa, que se manifiesta por signos y síntomas motores y no motores, que comprometen la calidad de vida de los pacientes. El Parkinson Disease Questionnaire (PDQ-39) es el instrumento más utilizado para evaluar la calidad de vida en pacientes con esta enfermedad. Los objetivos del trabajo fueron identificar los aspectos relacionados con la Calidad de Vida desde la perspectiva de los pacientes, compararlos con los aspectos considerados por el PDQ-39 y describir las estrategias adoptadas por los pacientes para superar las dificultades. Materiales y métodos: estudio cualitativo, descriptivo. Se realizó un grupo focal con seis pacientes. Los datos fueron analizados usando el método de análisis de contenido. Resultados: aspectos relacionados a todos los dominios del PDQ-39 fueron mencionados por los pacientes, destacándose aquellos relacionados con las limitaciones de la movilidad y el desarrollo de actividades diarias, y aspectos relacionados con el bienestar emocional. No obstante, algunos aspectos considerados en el dominio movilidad del PDQ-39 no fueron mencionados, y fueron detectadas limitaciones del dominio bienestar emocional. Los pacientes diseñan diversas estrategias para superar las dificultades, en las que el soporte social es importante. Conclusión: conocer y reflexionar sobre las percepciones de persona con enfermedad de Parkinson sobre su calidad de vida contribuye para la comprensión de la enfermedad y auxilia la propuesta de intervenciones clínicas adecuadas para lograr el cuidado integral. Se sugiere la revisión y adaptación del PDQ-39 al contexto actual, los avances tecnológicos y de conocimientos sobre la enfermedad de Parkinson.

Resumo Introdução: a doença de Parkinson é uma patologia neurodegenerativa, que se manifesta por signos e sintomas motores e não motores, que comprometem a qualidade de vida dos pacientes. O Parkinson Disease Questionnaire (PDQ-39) é o instrumento mais utilizado para avaliar a qualidade de vida de em pacientes com esta doença. Os objetivos do trabalho foram identificar os aspetos relacionados com a Qualidade de Vida desde a perspectiva dos pacientes, compará-los com os aspetos considerados pelo PDQ-39 e descrever as estratégias adotadas pelos pacientes para superar as dificuldades. Materiais e métodos: estudo qualitativo, descritivo. Realizou-se um grupo focal com seis pacientes. Os dados foram analisados usando o método de análise de conteúdo. Resultados: aspetos relacionados a todos os domínios do PDQ-39 foram mencionados pelos pacientes, destacando-se aqueles relacionados com as limitações da mobilidade e o desenvolvimento de atividades diárias, e aspetos relacionados com o bem-estar emocional. No entanto, alguns aspectos considerados no domínio mobilidade do PDQ-39 não foram mencionados, e foram detectadas limitações do domínio bem-estar emocional. Os pacientes desenham diversas estratégias para superar as dificuldades, nas que o suporte social é importante. Conclusão: conhecer e reflexionar sobre as percepções de pessoas com Doença de Parkinson sobre sua qualidade de vida contribui para a compreensão da doença e auxilia a proposta de intervenções clínicas adequadas para conseguir o cuidado integral. Sugere-se a revisão e adaptação do PDQ-39 ao contexto atual, os avanços tecnológicos e de conhecimentos sobre a Doença de Parkinson.

Perfil de acceso y uso de medicamentos en un municipio del sur de Brasil* / Profile of access and use of drugs in a municipality of southern Brazil

Introducción: En Brasil, el acceso a medicamentos es considerado parte integral del derecho a la salud y es garantizado, junto con su uso racional, por la Política Nacional de Asistencia Farmacéutica en el Sistema Único de Salud Objetivo: Identificar el perfil de acceso y uso de medicamentos de usuarios del citado Sistema. Métodos: Estudio descriptivo realizado en el municipio de Balneario Piçarras, sur de Brasil. Se entrevistaron en su domicilio 936 personas, seleccionadas aleatoriamente de los registros del Sistema de Atención Básica del Sistema Único de Salud. Resultados: De los entrevistados, 60,1 por ciento manifestó haber usado medicamentos en los últimos 15 días. Se encontró mayor probabilidad de uso de medicamentos en mujeres, personas mayores de 40 años y pensionados (p<0,05). De los 1 393 medicamentos utilizados, el 16,4 por ciento eran automedicados, principalmente antiinflamatorios no esteroideos. El 98,8 por ciento de los medicamentos fueron prescitos por médicos del Sistema y pertenecían a la Relación Municipal de Medicamentos Esenciales. Los usuarios los obtuvieron en las Unidades Básicas de Salud. Se encontró mayor adherencia a la Relación Municipal por parte de los médicos del Sistema (79,2 por ciento), que de los médicos particulares (61,1 por ciento). Los 104 usuarios de medicamentos presentaron 118 interacciones medicamentosas. El riesgo de interacción aumentó con el número de medicamentos utilizados. Conclusiones: Existe buena cobertura y acceso a medicamentos en el Sistema Único de Salud, pero aún es necesario el fortalecimiento de estrategias que promuevan su uso adecuado, como es la mayor participación del profesional farmacéutico en los servicios de salud(AU)

Introduction: In Brazil access to medicines is considered a comprehensive part of the right to health. Objective: To identify the profile of access and use of medicines of the Sole Health System´s users. Methods: A descriptive and cross-sectional study in Balneario Piçarras municipality, Santa Catarina State, in southern Brazil. 936 people were randomly selected from the records of the Sole Health System´s Basic Care System, whom were interviewed at home. Results: Out of those interviewed, 60.1 percent reported having used medications in the last 15 days. There was a greater probability of drugs using in women, people over 40 years old and pensioners (p<0,05). Out of the 1 393 drugs used, 16.4 percent were used in a self-medicated way, mostly non-steroidal anti-inflammatory drugs. 98.8 percent of the medicines belonged to the Municipal List of Essential Medications, which are prescribed by physicians of the System and that were obtained by the users in the Basic Health Units. The average number of drugs per person was 2.5. The 104 drug users had 118 drug interactions (an average of 1.7 interactions per user), and the risk of interaction increased with the number of drugs used. Conclusions: There is good coverage and access to drugs in the Sole Health System, but it is still necessary to strengthen strategies that promote their adequate use. There is a need for greater participation of pharmaceutical professionals in health services(AU)

Perfil de acceso y uso de medicamentos en un municipio del sur de Brasil* / Profile of access and use of drugs in a municipality of southern Brazil

Introducción: En Brasil, el acceso a medicamentos es considerado parte integral del derecho a la salud y es garantizado, junto con su uso racional, por la Política Nacional de Asistencia Farmacéutica en el Sistema Único de Salud Objetivo: Identificar el perfil de acceso y uso de medicamentos de usuarios del citado Sistema. Métodos: Estudio descriptivo realizado en el municipio de Balneario Piçarras, sur de Brasil. Se entrevistaron en su domicilio 936 personas, seleccionadas aleatoriamente de los registros del Sistema de Atención Básica del Sistema Único de Salud. Resultados: De los entrevistados, 60,1 por ciento manifestó haber usado medicamentos en los últimos 15 días. Se encontró mayor probabilidad de uso de medicamentos en mujeres, personas mayores de 40 años y pensionados (p<0,05). De los 1 393 medicamentos utilizados, el 16,4 por ciento eran automedicados, principalmente antiinflamatorios no esteroideos. El 98,8 por ciento de los medicamentos fueron prescitos por médicos del Sistema y pertenecían a la Relación Municipal de Medicamentos Esenciales. Los usuarios los obtuvieron en las Unidades Básicas de Salud. Se encontró mayor adherencia a la Relación Municipal por parte de los médicos del Sistema (79,2 por ciento), que de los médicos particulares (61,1 por ciento). Los 104 usuarios de medicamentos presentaron 118 interacciones medicamentosas. El riesgo de interacción aumentó con el número de medicamentos utilizados. Conclusiones: Existe buena cobertura y acceso a medicamentos en el Sistema Único de Salud, pero aún es necesario el fortalecimiento de estrategias que promuevan su uso adecuado, como es la mayor participación del profesional farmacéutico en los servicios de salud(AU)

Introduction: In Brazil access to medicines is considered a comprehensive part of the right to health. Objective: To identify the profile of access and use of medicines of the Sole Health System´s users. Methods: A descriptive and cross-sectional study in Balneario Piçarras municipality, Santa Catarina State, in southern Brazil. 936 people were randomly selected from the records of the Sole Health System´s Basic Care System, whom were interviewed at home. Results: Out of those interviewed, 60.1 percent reported having used medications in the last 15 days. There was a greater probability of drugs using in women, people over 40 years old and pensioners (p<0,05). Out of the 1 393 drugs used, 16.4 percent were used in a self-medicated way, mostly non-steroidal anti-inflammatory drugs. 98.8 percent of the medicines belonged to the Municipal List of Essential Medications, which are prescribed by physicians of the System and that were obtained by the users in the Basic Health Units. The average number of drugs per person was 2.5. The 104 drug users had 118 drug interactions (an average of 1.7 interactions per user), and the risk of interaction increased with the number of drugs used. Conclusions: There is good coverage and access to drugs in the Sole Health System, but it is still necessary to strengthen strategies that promote their adequate use. There is a need for greater participation of pharmaceutical professionals in health services(AU)

Towards a theoretical model on medicines as a health need.

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

Medication Therapy Management Service for Patients with Parkinson's Disease: A Before-and-After Study.

BACKGROUND: Parkinson's disease (PD) is a neurodegenerative disease characterized by motor manifestations, autonomic and neurological disorders and sensorial symptoms. Medication therapy management (MTM) consists of a service undertaken by pharmacists to optimize pharmacological therapy results. This way, the pharmacist monitors the treatment prescribed by the doctor and formulates a healthcare plan to guarantee the treatment's effectiveness, safety and convenience, thereby improving the patient's quality of life (QoL). OBJECTIVE: To analyze the effect of MTM upon medicine-related problems, motor symptoms, autonomic disorders and QoL of patients with Parkinson's disease, and describe the pharmaceutical interventions. METHODS: Quasi-experimental uncontrolled before-and-after study carried out between September 2012 and March 2013 in a community pharmacy. Pharmacotherapy data were collected from medical prescriptions, patient diaries, medical charts and all the medicines (over-the-counter and prescription) brought by the patients to the appointment with the pharmacist. The medicine-related problems were classified as indication, effectiveness, safety and adherence. Adherence was measured through clinical interviews and the Morisky questionnaire. PD symptoms were assessed according to the patients' and/or caregivers' perceptions about the On/Off state of the motor symptoms and relief of the nonmotor symptoms. QoL was assessed using the PDQ-39 scores. The interventions were targeted to patients/caregivers and/or doctors, with pharmacological and non-pharmacological measures. RESULTS: Seventy patients were followed up, showing a decrease in medicine-related problems (1.67 ± 1.34 to 0.8 ± 0.9 (p < 0.001), positive impact on adherence (from 37 to 10 non-adherent patients, p < 0.001), QoL improvement related to emotional wellbeing (p = 0.012) and autonomic disorder. Most interventions were performed directly with the patients (73.8%), including non-pharmacological guidance (28.5%), pharmacological guidance (24.3%) and rescheduling (13.6%). CONCLUSIONS: To carry out MTM with PD patients, the pharmacist's expertise needs to transcend the technical knowledge about the PD pharmacological treatment. The study showed a positive effect with a decrease in the medicine-related problems after the interventions, especially improving adherence and patients' QoL.