[A creative approach to psychoeducation for ADHD in adults]. / Une offre de soins créative de psychoéducation du TDAH chez l'adulte.

A group-based online psycho-education program for adults with attention deficit hyperactivity disorder (ADHD) and their families has been set up by a multi-professional psychiatric team. Feedback from users has mainly shown benefits in terms of improving self-esteem, destigmatization and accessibility to care. This suggests a real interest in developing this care offer in the pathway of ADHD adults.

Facilitators of and barriers to County Behavioral Health System Transformation and Innovation: an interview study.

BACKGROUND: Inadequate and inequitable access to quality behavioral health services and high costs within the mental health systems are long-standing problems. System-level (e.g., fee-for-service payment model, lack of a universal payor) and individual factors (e.g., lack of knowledge of existing resources) contribute to difficulties in accessing resources and services. Patients are underserved in County behavioral health systems in the United States. Orange County's (California) Behavioral Health System Transformation project sought to improve access by addressing two parts of their system: developing a template for value-based contracts that promote payor-agnostic care (Part 1); developing a digital platform to support resource navigation (Part 2). Our aim was to evaluate facilitators of and barriers to each of these system changes. METHODS: We collected interview data from County or health care agency leaders, contracted partners, and community stakeholders. Themes were informed by the Consolidated Framework for Implementation Research. RESULTS: Five themes were identified related to behavioral health system transformation, including 1) aligning goals and values, 2) addressing fit, 3) fostering engagement and partnership, 4) being aware of implementation contexts, and 5) promoting communication. A lack of fit into incentive structures and changing state guidelines and priorities were barriers to contract development. Involving diverse communities to inform design and content facilitated the process of developing digital tools. CONCLUSIONS: The study highlights the multifaceted factors that help facilitate or hinder behavioral health system transformation, such as the need for addressing systematic and process behaviors, leveraging the knowledge of leadership and community stakeholders, fostering collaboration, and adapting to implementation contexts.

Agents of Change: Geriatrics Workforce Programs Addressing Systemic Racism and Health Equity.

Many factors affect how individuals and populations age, including race, ethnicity, and diversity, which can contribute to increased disease risk, less access to quality healthcare, and increased morbidity and mortality. Systemic racism-a set of institutional policies and practices within a society or organization that perpetuate racial inequalities and discrimination-contributes to health inequities of vulnerable populations, particularly older adults. The National Association for Geriatrics Education (NAGE) recognizes the need to address and eliminate racial disparities in healthcare access and outcomes for older adults who are marginalized due to the intersection of race and age. In this paper, we discuss an anti-racist framework that can be used to identify where an organization is on a continuum to becoming anti-racist and to address organizational change. Examples of NAGE member Geriatric Workforce Enhancement Programs (GWEPs) and Geriatrics Academic Career Awards (GACAs) activities to become anti-racist are provided to illustrate the framework and to guide other workforce development programs and healthcare institutions as they embark on the continuum to become anti-racist and improve the care and health of vulnerable older adults.

XI Reunión Ad Hoc del Grupo Técnico Asesor (GTA) sobre Enfermedades Prevenibles por Vacunación. 21 de noviembre del 2023. Reunión virtual

La Región de las Américas está recuperando sus tasas de cobertura de inmunización para la mayoría de los antígenos. En el 2022, la tasa de cobertura de la tercera dosis de la vacuna contra la difteria, el tétanos y la tos ferina (DTP3) fue del 90%, frente al 86% en 2021. En total, 1,3 millones de niños menores de 1 año siguen sin vacunar, frente a los 1,9 millones de 2021. Por supuesto, el camino hacia la recuperación de la pandemia de COVID-19 es largo, pero las Américas están mostrando signos de progreso. En 2002, los casos de dengue superaron el millón, mientras que en 2013 se registraron más de 2 millones, y más de 3 millones en 2019. Aunque la tasa regional de letalidad por dengue se mantiene por debajo del 0,05%, el aumento de la transmisión está socavando los esfuerzos de recuperación social y económica de los países. En septiembre de 2023, el Grupo de Expertos en Asesoramiento Estratégico (SAGE) sobre Inmunización de la Organización Mundial de la Salud (OMS) recomendó el uso de la serie de dos dosis de la vacuna contra el dengue TAK-003 producida por Takeda para niños de 6 a 16 años que viven en entornos con alta carga de enfermedad por dengue y alta intensidad de transmisión. Durante esta XI reunión del Grupo Técnico Asesor (GTA), la Secretaría de la Organización Panamericana de la Salud (OPS) pidió a los miembros del GTA que consideraran la evidencia sobre la seguridad y eficacia de esta vacuna y propusieran recomendaciones para su uso en las Américas. Asimismo, el virus sincitial respiratorio (VSR) es motivo de gran preocupación en las Américas. Los datos notificados por los Estados Miembros a la red integrada de vigilancia respiratoria SARInet Plus de la OPS indican que el VSR contribuye significativamente a la carga de enfermedades respiratorias en la Región. Por grupos de edad, los casos y hospitalizaciones asociados al VSR se han notificado principalmente entre lactantes menores de 2 años. En los últimos meses, tanto la Administración de Alimentos y Medicamentos de EE.UU. (FDA) como la Agencia Europea del Medicamento (EMA) han aprobado la vacuna Abrysvo contra el VRSpreF producida por Pfizer para mujeres embarazadas, con el objetivo de reducir la incidencia del VRS entre los recién nacidos menores de 6 meses. Una vez más, los miembros del GAT fueron convocados para proporcionar sus recomendaciones a la OPS sobre el uso de esta vacuna en las Américas.

Servicios farmacéuticos basados en la atención primaria de salud: Herramienta para la evaluación de la calidad de la prestación de los servicios farmacéuticos en países de la Región de las Américas / Pharmaceutical services based on primary health care: Tool for evaluating the quality of the provision of pharmaceutical services in countries of the Region of the Americas

El presente documento ofrece una herramienta robusta que consta de 79 indicadores, basados en los principios de una atención primaria de salud renovada, y diseñados para ser implementados en los servicios farmacéuticos de la Región. En estas páginas se resume el proceso de desarrollo de estos indicadores, iniciado en el 2019 bajo la dirección y coordinación de la Organización Panamericana de la Salud, con aportes del grupo expertos en el tema, talleres regionales y una prueba piloto en Argentina y Perú en el 2022. Asimismo, se describe el enfoque simplificado de niveles de implementación, que facilita la compresión de los resultados de los indicadores y la toma de decisiones, y además, se incluyen algunos elementos clave para que los países los tengan en cuenta en el momento de implementar esta herramienta. Cada indicador se presenta en su correspondiente ficha técnica, que incluye los elementos configurativos, la clasificación según el grado de complejidad y el ámbito de los servicios farmacéuticos. Esto destaca la importancia de redefinir y evaluar la calidad de los servicios farmacéuticos en todos los niveles de atención de salud.

OPAS pede que as Américas adotem tecnologias e tratamentos inovadores para eliminar a tuberculose

Às vésperas do Dia Mundial da Tuberculose, que ocorre em 24 de março, a Organização Pan-Americana da Saúde (OPAS) faz um apelo para intensificar a luta contra esta doença evitável e curável. A tuberculose ou TB é a principal causa de morte por um único agente infeccioso em todo o mundo, superada apenas pela COVID-19.

Fiocruz lança Estratégia para Terapias Avançadas no tratamento de câncer e doenças raras

Como parte da Estratégia e em parceria com o Ministério da Saúde (MS), a Fundação assinou um acordo de colaboração com a organização norte-americana sem fins lucrativos Caring Cross, que prevê a transferência de tecnologia, pelo Instituto de Tecnologia em Imunobiológicos (Bio-Manguinhos/Fiocruz), para a produção de células CAR-T e vetores lentivirais.

Servicios farmacéuticos basados en la atención primaria de salud: Herramienta para la evaluación de la calidad de la prestación de los servicios farmacéuticos en países de la Región de las Américas

Este documento ofrece una herramienta robusta que consta de 79 indicadores, basados en los principios de una atención primaria de salud renovada, y diseñados para ser implementados en los servicios farmacéuticos de la Región. En estas páginas se resume el proceso de desarrollo de estos indicadores, iniciado en el 2019 bajo la dirección y coordinación de la Organización Panamericana de la Salud, con aportes del grupo expertos en el tema, talleres regionales y una prueba piloto en Argentina y Perú en el 2022. Asimismo, se describe el enfoque simplificado de niveles de implementación, que facilita la compresión de los resultados de los indicadores y la toma de decisiones, y además, se incluyen algunos elementos clave para que los países los tengan en cuenta en el momento de implementar esta herramienta. Cada indicador se presenta en su correspondiente ficha técnica, que incluye los elementos configurativos, la clasificación según el grado de complejidad y el ámbito de los servicios farmacéuticos. Esto destaca la importancia de redefinir y evaluar la calidad de los servicios farmacéuticos en todos los niveles de atención de salud. Este instrumento será útil para las autoridades sanitarias, al permitir la adaptación según las capacidades y objetivos de cada país. Servirá además como recurso de autoevaluación para los servicios farmacéuticos, al facilitar la formulación de planes de mejora continua. El público destinatario incluye a las autoridades sanitarias, asociaciones y colegios de profesionales farmacéuticos, la academia y todas las personas involucradas en la gestión y seguimiento de la atención de los servicios farmacéuticos.

Desafios e possibilidades da jurimetria na judicialização em saúde: uma investigação em Minas Gerais do período 2014 a 2020 / Challenges and possibilities of jurimetry in health judicialization: an investigation in Minas Gerais state from 2014 2020 / Desafíos y posibilidades de la jurimetría en la judicialización de la salud: una investigación en Minas Gerais de 2014 a 2020

Objetivo: analisar os processos de saúde, de medicamentos e de medicamentos antineoplásicos em Minas Gerais, em 2014 a 2020, a partir da comparação de diferentes bases de dados. Metodologia: foram utilizadas técnicas de pareamento de bases de dados entre os processos existentes no Tribunal de Justiça do Estado de Minas Gerais e os processos recebidos pela Secretaria Estadual de Saúde de Minas Gerais, descreveram-se as dificuldades encontradas na identificação e quantificação desses processos, e os resultados encontrados foram comparados com informações provenientes de outras fontes. Resultados: nas bases do Tribunal de Justiça de Minas Gerais foram identificados 564.763 processos de saúde. Houve um aumento significativo do número de processos até 2017 e uma estabilização, em patamares altos, a partir de 2017. Ao comparar com os resultados obtidos pelo Instituto Superior de Ensino e Pesquisa e pelo Laboratório de Inovação, Inteligência e Objetivos de Desenvolvimento Sustentável, houve uma importante divergência nos números de processos. Tomando como exemplo a judicialização de saúde contra o estado de Minas Gerais, não foi possível encontrar de forma direta todos os processos recebidos pela Secretaria Estadual de Saúde de Minas Gerais nas diversas bases fornecidas pelo Tribunal de Justiça de Minas Gerais, tendo sido necessária uma integração entre as diferentes bases de dados e uma busca adicional para identificar todos os processos. Conclusão: recomendam-se a padronização e organização dos dados dos processos judiciais em saúde, já na entrada de dados, para facilitar a realização de estudos quantitativos sobre a judicialização da saúde.

Objective: to analyze the health, drug, and antineoplastic drug lawsuits in Minas Gerais, in 2014 to 2020, from the comparison of different databases. Methodology: database pairing techniques were used to link lawsuits from the Minas Gerais State Court of Justice with the processes received by the Minas Gerais Health State Department, the difficulties encountered in identifying and quantifying these processes were described, and the results found were compared with information from other sources. Results: in the Minas Gerais State Court of Justice databases, 564,763 health lawsuits were identified in the studied period. There was a significant increase in the number of processes until 2017 and a stabilization, at high levels, from 2017 onwards. In comparison with the results obtained by the Institute of Higher Education and Research and the Laboratory of Innovation, Intelligence and Sustainable Development Goals there was a great divergence in the number of processes found. Conclusion: taking the health judicialization against Minas Gerais state as an example, it was not possible to directly find all the processes received by Minas Gerais Health State Department in the various databases provided by the Minas Gerais State Court of Justice, requiring integration between the different databases and an additional search to identify all processes.

Objetivo: analizar los juicios de salud, drogas y medicamentos antineoplásicos en Minas Gerais, en 2014 a 2020, a partir de la comparación de diferentes bases de datos. Metodología: técnicas de emparejamiento de bases de datos fueron utilizadas para vincular los juicios existentes en el Tribunal de Justicia del Estado de Minas Gerais con los procesos recibidos por la Secretaría de Estado de Salud de Minas Gerais, las dificultades encontradas en la identificación y cuantificación de esos procesos fueron descritas, y los resultados encontrados fueron comparados con informaciones de otras fuentes. Resultados: en las bases del Tribunal de Justicia del Estado de Minas Gerais se identificaron 564.763 procesos de salud. Hubo un aumento significativo en el número de procesos hasta 2017 y una estabilización, en niveles altos, a partir de 2017. Sin embargo, al comparar con los resultados obtenidos por el Instituto Superior de Educación e Investigación y por el Laboratorio de Innovación, Inteligencia y Objetivos de Desarrollo Sostenible hubo una divergencia importante en el número de procesos. Conclusión: tomando como ejemplo la judicialización de la salud contra el estado de Minas Gerais, no era posible encontrar directamente todos los procesos recibidos por la Secretaría de Estado de Salud de Minas Gerais en las diversas bases de datos proporcionadas por el Tribunal de Justicia del Estado de Minas Gerais, lo que requería una integración entre las diferentes bases de datos y una búsqueda adicional a identificar todos los procesos.

Problemática del acceso a los medicamentos: disponibilidad y la producción local en América latina / Problems of Access to Medicines: Availability and Local Production in Latin America

La desigualdad en el acceso a los medicamentos se percibe como un síntoma de las deficiencias del sistema sanitario y supone un incumplimiento por parte de los gobiernos de sus obligaciones para con sus ciudadanos en cuanto a su derecho a la protección de la salud.Integrar la perspectiva de la salud como derecho inherente de la población y, al mismo tiempo, la perspectiva de la salud como espacio estratégico de desarrollo de la base productiva y tecnológica, creación de valor, generación de inversiones, ingreso, empleo, conocimiento e innovación, son claves para mejorar el acceso.El objetivo de este trabajo es presentar la problemática del acceso a los medicamentos desde la perspectiva de la disponibilidad de los mismos y exponer la situación del mercado de América Latina.El escenario de América Latina es complejo: países con realidades económicas distintas, proyectos fallidos de integración, gasto en salud pública por debajo del 6%, escasa inversión en investigación y desarrollo, preferencia a las importaciones, legislación no convergente y tendencias al nacionalismo de los países de altos ingresos para el retorno de la producción al país de origen. A pesar de las limitaciones descritas, en la región existen capacidades productivas que deben ser fortalecidas. Brasil, Argentina, México, Colombia y Chile son los países llamados a liderar la producción regional a través de la diversificación. En este momento la solución pasa por que en la región se antepongan los proyectos regionales frente a los intereses individuales, para con ello lograr la autosuficiencia sanitaria.(AU)

Inequality in access to medicines is perceived as a symptom of the weaknesses of the health system and implies a failure on the part of governments to fulfill their obligations to their citizens in terms of their right to health protection.Integrating the perspective of health as an inherent right of the population and, at the same time, the perspective of health as a strategic space for the development of the productive and technological base, value creation, generation of investment, income, employment, knowledge and innovation, are key to improving access.The objective of this paper is to present the problem of access to medicines from the perspective of their availability and to describe the situation of the Latin American market.The Latin American scenario is complex: countries with different economic realities, failed integration projects, public health spending below 6%, low investment in research and development, preference for imports, non-convergent legislation and tendencies towards nationalism in high-income countries for the return of production to the country of origin. Despite the limitations described above, there are productive capacities in the region that need to be strengthened. Brazil, Argentina, Mexico, Colombia and Chile are the countries called upon to lead regional production through diversification. At this time, the solution is for the region to put regional projects before individual interests in order to achieve sanitary self-sufficiency.(AU)

Research on the impact of China's reform to delegate power, streamline administration, and optimize government services on the technology innovation efficiency of the pharmaceutical manufacturing industry.

Objective: The government has recently implemented reforms aimed at delegating power, streamlining administration, and optimizing government services. This reform has eliminated barriers that impede the growth of various industries, thereby unleashing innovative potential. Additionally, there have been several medical policies, including changes to medical insurance and centralized volume-based procurement. China's pharmaceutical market has undergone significant changes, leading to increased demands for innovation technology efficiency in pharmaceutical manufacturing. Methods: The three-stage BCC theory was employed to assess the effectiveness of technology innovation in the industry under this reform. Calculate precise comprehensive technical efficiency values, pure technical efficiency values, and scale efficiency values for technological innovation in the pharmaceutical industry across 30 provinces from 2018 to 2020, after removing environmental factors. Results: In 2020, Jiangsu and Shandong and nine other provinces reached the comprehensive technical efficiency frontier surface, joining Tianjin, Zhejiang, and Guangdong provinces. However, Gansu, Qinghai, Ningxia, and Xinjiang still need to catch up due to their smaller industrial scale and lack of technology. Discussion: To ensure the effectiveness of reforms, it is crucial to fully consider provincial differences. Articulating national and provincial policies is necessary to allow efficient provinces to continue and allocate resources toward less efficient provinces to improve overall efficiency.

Invention of MK-7845, a SARS-CoV-2 3CL Protease Inhibitor Employing a Novel Difluorinated Glutamine Mimic.

As SARS-CoV-2 continues to circulate, antiviral treatments are needed to complement vaccines. The virus's main protease, 3CLPro, is an attractive drug target in part because it recognizes a unique cleavage site, which features a glutamine residue at the P1 position and is not utilized by human proteases. Herein, we report the invention of MK-7845, a novel reversible covalent 3CLPro inhibitor. While most covalent inhibitors of SARS-CoV-2 3CLPro reported to date contain an amide as a Gln mimic at P1, MK-7845 bears a difluorobutyl substituent at this position. SAR analysis and X-ray crystallographic studies indicate that this group interacts with His163, the same residue that forms a hydrogen bond with the amide substituents typically found at P1. In addition to promising in vivo efficacy and an acceptable projected human dose with unboosted pharmacokinetics, MK-7845 exhibits favorable properties for both solubility and absorption that may be attributable to the unusual difluorobutyl substituent.

Efficacy and safety of a structured de-escalation from antipseudomonal ß-lactams in bloodstream infections due to Enterobacterales (SIMPLIFY): an open-label, multicentre, randomised trial.

BACKGROUND: De-escalation from broad-spectrum to narrow-spectrum antibiotics is considered an important measure to reduce the selective pressure of antibiotics, but a scarcity of adequate evidence is a barrier to its implementation. We aimed to determine whether de-escalation from an antipseudomonal ß-lactam to a narrower-spectrum drug was non-inferior to continuing the antipseudomonal drug in patients with Enterobacterales bacteraemia. METHODS: An open-label, pragmatic, randomised trial was performed in 21 Spanish hospitals. Patients with bacteraemia caused by Enterobacterales susceptible to one of the de-escalation options and treated empirically with an antipseudomonal ß-lactam were eligible. Patients were randomly assigned (1:1; stratified by urinary source) to de-escalate to ampicillin, trimethoprim-sulfamethoxazole (urinary tract infections only), cefuroxime, cefotaxime or ceftriaxone, amoxicillin-clavulanic acid, ciprofloxacin, or ertapenem in that order according to susceptibility (de-escalation group), or to continue with the empiric antipseudomonal ß-lactam (control group). Oral switching was allowed in both groups. The primary outcome was clinical cure 3-5 days after end of treatment in the modified intention-to-treat (mITT) population, formed of patients who received at least one dose of study drug. Safety was assessed in all participants. Non-inferiority was declared when the lower bound of the 95% CI of the absolute difference in cure rate was above the -10% non-inferiority margin. This trial is registered with EudraCT (2015-004219-19) and ClinicalTrials.gov (NCT02795949) and is complete. FINDINGS: 2030 patients were screened between Oct 5, 2016, and Jan 23, 2020, of whom 171 were randomly assigned to the de-escalation group and 173 to the control group. 164 (50%) patients in the de-escalation group and 167 (50%) in the control group were included in the mITT population. 148 (90%) patients in the de-escalation group and 148 (89%) in the control group had clinical cure (risk difference 1·6 percentage points, 95% CI -5·0 to 8·2). The number of adverse events reported was 219 in the de-escalation group and 175 in the control group, of these, 53 (24%) in the de-escalation group and 56 (32%) in the control group were considered severe. Seven (5%) of 164 patients in the de-escalation group and nine (6%) of 167 patients in the control group died during the 60-day follow-up. There were no treatment-related deaths. INTERPRETATION: De-escalation from an antipseudomonal ß-lactam in Enterobacterales bacteraemia following a predefined rule was non-inferior to continuing the empiric antipseudomonal drug. These results support de-escalation in this setting. FUNDING: Plan Nacional de I+D+i 2013-2016 and Instituto de Salud Carlos III, Subdirección General de Redes y Centros de Investigación Cooperativa, Ministerio de Ciencia, Innovación y Universidades, Spanish Network for Research in Infectious Diseases; Spanish Clinical Research and Clinical Trials Platform, co-financed by the EU; European Development Regional Fund "A way to achieve Europe", Operative Program Intelligence Growth 2014-2020.

Derrotar a meningite até 2030 - Um Roteiro Mundial

A meningite é letal e debilitante; ela ataca rapidamente, tem graves consequências sociais, econômicas e de saúde e afeta pessoas de todas as idades em todos os países do mundo. A meningite bacteriana pode causar epidemias, levar à morte em menos de 24 horas e deixar um em cada cinco pacientes com deficiência permanente após a infecção. Muitos casos e mortes por meningite podem ser evitados com vacinas, mas o progresso na luta contra a meningite está atrasado em relação a outras doenças imunopreveníveis. Este primeiro roteiro mundial de meningite define um plano para combater as principais causas de meningite bacteriana aguda (meningococo, pneumococo, Haemophilus influenzae e estreptococo do grupo B). O roteiro da meningite foi designado como uma estratégia global emblemática do Décimo Terceiro Programa Geral de Trabalho da OMS, 2019–2023, e é um componente vital para alcançar a cobertura universal de saúde. O roteiro reforçará e se combinará com iniciativas mais amplas, como as que visam fortalecer a atenção primária à saúde e os sistemas de saúde, aumentar a cobertura de imunização, melhorar a segurança sanitária mundial, combater a resistência aos antimicrobianos e defender os direitos das pessoas com deficiência.

XIe réunion spéciale du Groupe consultatif technique (GCT) de l'OPS sur les maladies évitables par la vaccination, 21 novembre 2023. Réunion virtuelle

La Région des Amériques retrouve ses taux de couverture vaccinale pour la plupart des antigènes. En 2022, le taux de couverture pour la troisième dose du vaccin contre la diphtérie, le tétanos et la coqueluche (DTC3) était de 90 %, contre 86 % en 2021. Dans l'ensemble, 1,3 million d'enfants de moins d'un an ne sont pas vaccinés, contre 1,9 million en 2021. En 2002, les cas de dengue ont dépassé le million, alors que plus de 2 millions ont été enregistrés en 2013, et plus de 3 millions en 2019. Alors que le taux de létalité de la dengue dans la région reste inférieur à 0,05 %, l'augmentation de la transmission compromet les efforts de redressement social et économique des pays. En septembre 2023, le Groupe consultatif stratégique d'experts (SAGE) de l'OMS sur la vaccination a recommandé l'utilisation de la série de deux doses du vaccin contre la dengue TAK-003 produit par Takeda pour les enfants âgés de 6 à 16 ans qui vivent dans des environnements où la charge de morbidité et l'intensité de la transmission de la dengue sont élevées. Au cours de cette XIe réunion du groupe consultatif technique (GCT), le secrétariat de l'OPS a demandé aux membres du GCT d'examiner les preuves de l'innocuité et de l'efficacité de ce vaccin et de proposer des recommandations pour son utilisation dans les Amériques. Par ailleurs, le virus respiratoire syncytial suscite (VRS) de vives inquiétudes dans les Amériques. Les données communiquées par les États membres au réseau intégré de surveillance respiratoire SARInet Plus de l'OPS indiquent que le VRS contribue de manière significative à la charge de morbidité respiratoire dans la région. Par groupe d'âge, les cas et les hospitalisations associés au VRS ont été principalement signalés chez les nourrissons de moins de 2 ans. Ces derniers mois, la Food and Drug Administration des États-Unis et l'Agence européenne des médicaments ont toutes deux approuvé le vaccin RSVpreF Abrysvo produit par Pfizer pour les femmes enceintes, dans le but de réduire l'incidence du VRS chez les nouveau-nés de moins de 6 mois.

XI Reunião Ad Hoc do Grupo Técnico Assessor (GTA) da OPAS sobre Doenças Imunopreveníveis, 21 de novembro de 2023. Reunião Virtual

A Região das Américas está recuperando suas taxas de cobertura de imunização para a maioria dos antígenos. Em 2022, a taxa de cobertura para a terceira dose da vacina contra difteria, tétano e coqueluche (DTP3) foi de 90% - acima dos 86% em 2021. No geral, 1,3 milhão de crianças com menos de 1 ano de idade continuam sem vacinação, em comparação com 1,9 milhão em 2021. Em 2002, os casos de dengue ultrapassaram 1 milhão, enquanto mais de 2 milhões foram registrados em 2013 e mais de 3 milhões em 2019. Embora a taxa regional de fatalidade de casos de dengue permaneça abaixo de 0,05%, o aumento da transmissão está prejudicando os esforços dos países para a recuperação social e econômica. Em setembro de 2023, o Grupo Consultivo Estratégico de Especialistas (SAGE) em Imunização da Organização Mundial da Saúde (OMS) recomendou o uso da série de duas doses da vacina contra a dengue TAK-003, produzida pela Takeda, para crianças de 6 a 16 anos de idade que vivem em ambientes com alta carga da doença da dengue e alta intensidade de transmissão. Durante essa XI reunião do Grupo Técnico Consultivo (TAG), a Secretaria da Organização Pan-Americana da Saúde (OPAS) solicitou aos membros do TAG que considerassem as evidências sobre a segurança e a eficácia dessa vacina e propusessem recomendações para seu uso nas Américas. Além disso, o vírus sincicial respiratório (VSR) é motivo de grande preocupação nas Américas. Os dados informados pelos Estados Membros à rede de vigilância respiratória integrada SARInet Plus da OPAS indicam que o VSR contribui significativamente para a carga de doenças respiratórias na Região. Por faixa etária, os casos e hospitalizações associados ao RSV foram registrados principalmente em bebês com menos de 2 anos de idade. Nos últimos meses, tanto a Food and Drug Administration (FDA) dos EUA quanto a European Medicines Agency (EMA) aprovaram a vacina RSVpreF Abrysvo produzida pela Pfizer para mulheres grávidas, com o objetivo de reduzir a incidência de RSV entre recém-nascidos com menos de 6 meses. Mais uma vez, os membros do GTA foram chamados a fornecer suas recomendações à OPAS sobre o uso dessa vacina nas Américas.

XI Ad Hoc Meeting of the PAHO Technical Advisory Group (TAG) on Vaccine-Preventable Diseases, 21 November 2023. Virtual

The Region of the Americas is recovering its immunization coverage rates for most antigens. In 2022, the coverage rate for the third dose of the vaccine against diphtheria, tetanus, and pertussis (DTP3) was 90% – up from 86% in 2021. Overall, 1.3 million children younger than 1 year remain unvaccinated, compared to 1.9 million in 2021. Of course, the road to recovery from the COVID-19 pandemic is long, but the Americas are showing signs of progress. However, this progress is under threat from persistent infections that cause heavy burdens of disease in the Americas. Especially heavy is the burden of dengue virus. In 2002, dengue cases exceeded 1 million, whereas more than 2 million were recorded in 2013, and more than 3 million in 2019. While the regional dengue case fatality rate remains below 0.05%, the increased transmission is undermining countries’ efforts for social and economic recovery. In September 2023, the World Health Organization (WHO) Strategic Advisory Group of Experts (SAGE) on Immunization recommended the use of the two-dose TAK-003 dengue vaccine series produced by Takeda for children ages 6 to 16 years who live in settings with high dengue disease burden and high transmission intensity. During this XI Technical Advisory Group (TAG) meeting, the Pan American Health Organization (PAHO) Secretariat asked TAG members to consider the evidence on the safety and effectiveness of this vaccine and propose recommendations for its use in the Americas. Also, respiratory syncytial virus (RSV) is cause for great concern in the Americas. Data reported from Member States to the PAHO integrated respiratory surveillance network SARInet Plus indicate that RSV contributes significantly to the burden of respiratory diseases in the Region. By age group, RSV-associated cases and hospitalizations have been primarily reported among infants younger than 2 years. In recent months, both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) approved the RSVpreF vaccine Abrysvo produced by Pfizer for pregnant women, with the goal of reducing RSV incidence among newborns younger than 6 months. Again, TAG members were called to provide their recommendations to PAHO on the use of this vaccine in the Americas.

Servicios farmacéuticos basados en la atención primaria de salud: Herramienta para la evaluación de la calidad de la prestación de los servicios farmacéuticos en países de la Región de las Américas / Pharmaceutical services based on primary health care: Tool for evaluating the quality of the provision of pharmaceutical services in countries of the Region of the Americas

Este documento ofrece una herramienta robusta que consta de 79 indicadores, basados en los principios de una atención primaria de salud renovada, y diseñados para ser implementados en los servicios farmacéuticos de la Región. En estas páginas se resume el proceso de desarrollo de estos indicadores, iniciado en el 2019 bajo la dirección y coordinación de la Organización Panamericana de la Salud, con aportes del grupo expertos en el tema, talleres regionales y una prueba piloto en Argentina y Perú en el 2022. Asimismo, se describe el enfoque simplificado de niveles de implementación, que facilita la compresión de los resultados de los indicadores y la toma de decisiones, y además, se incluyen algunos elementos clave para que los países los tengan en cuenta en el momento de implementar esta herramienta.

Pivotal Trial Demographic Representation and Clinical Development Times for Oncology Therapeutics.

This study evaluates whether FDA-approved novel cancer therapeutics supported by pivotal trials with adequate representation of minoritized groups were associated with slower clinical development times than those with inadequate representation.

Has the consistency evaluation policy of generic drugs promoted the innovation quality of Chinese pharmaceutical manufacturing industry? An empirical study based on the difference-in-differences model.

Introduction: In March 2016, the Chinese government officially launched a nationwide consistency evaluation of the quality and efficacy of generic drugs. Methods: This paper conducted an empirical study using the Difference-in-Differences method to explore the effect of this policy on the innovation quality of China's pharmaceutical manufacturing industry and further analyzed the underlying mechanism of action. Results: The results of the study show that the generic consistency evaluation policy has a significant promotion effect on the innovation quality of China's pharmaceutical manufacturing industry, and the promotion effect is the largest for non-state-owned enterprises and enterprises in the central region; in addition, the intensity of R&D capital investment and R&D personnel investment which play a mediating role. Discussion: Therefore, we should fully recognize the positive effect of generic drug consistency evaluation policy on improving the innovation quality of the pharmaceutical manufacturing industry and pay attention to the necessity of regional coordination and unification in policy implementation and the formulation of supporting policy tools. This study provides empirical evidence for the implementation effect of the generic drug consistency evaluation policy, which can provide an essential reference for the further improvement of the procedure and the R&D decision-making of pharmaceutical enterprises.