Implementación de ensayos clínicos y acceso posensayo a vacunas para la COVID-19 en Latinoamérica / Implementation of clinical trials and post-trial access to COVID-19 vaccines in Latin America

Latinoamérica fue durante noviembre de 2020 una de las regiones más afectada por la pandemia de COVID-19 en cuanto a prevalencia y muertes atribuidas al virus. Por ello, el inicio de testeo de vacunas en ciudadanos de la región fue recibido con altas expectativas sobre su efectividad. Frente a lo cual es esencial tener en cuenta ciertos principios fundamentales que deben guiar este proceso asegurando su correcta implementación. El objetivo de este artículo es ofrecer consideraciones sobre el proceso de implementación de ensayos clínicos y acceso posensayo a vacunas para COVID-19 en Latinoamérica. En particular los relacionados con el respeto a la dignidad de los participantes, las tensiones históricas globales y regionales en materia de economía política de ensayos clínicos, algunos aspectos de la gobernanza global y el rol de la Organización Mundial de la Salud en la pandemia, y la necesidad de asegurar el acceso posensayo a la vacuna. Se concluye que la pandemia es una oportunidad para estrechar lazos de cooperación y solidaridad entre países latinoamericanos. Los ensayos clínicos son una instancia clave para reforzar la gobernanza local y regional con miras a fortalecer la transparencia y la vigilancia de la correcta realización de alianzas público-privadas en el desarrollo de terapias, en los que la Organización Mundial de la Salud y la Organización Panamericana de la Salud, tienen un rol importante para la implementación de estrategias de integración y acceso a vacunas(AU)

Latin America was during November 2020 one of the most affected regions by the COVID-19 pandemic in terms of prevalence and deaths attributed to the virus. Therefore, the start of vaccine testing in citizens of the region was received with high expectations about its effectiveness. Therefore, it is essential to take into account certain fundamental principles that should guide this process ensuring its correct implementation. The objective of this article is to provide considerations on the process of implementing clinical trials and post-trial access to COVID-19 vaccines in Latin America, in particular those related to respect for the dignity of participants, the historical global and regional tensions regarding the political economy of clinical trials, some aspects of global governance and the role of the World Health Organization in the pandemic, and the need to ensure post-trial access to the vaccine. It is concluded that the pandemic is an opportunity to strengthen bonds of cooperation and solidarity between Latin American countries. Clinical trials are a key instance to strengthen local and regional governance with a view to consolidate transparency and monitoring of the correct implementation of public-private partnerships in the development of therapies, in which the World Health Organization and the Pan American Health Organization have an important role for the implementation of integration strategies and access to vaccines(AU)

Participación ciudadana: mecanismos utilizados para captar información sobre valores y preferencias en procesos de decisiones de priorización o cobertura de salud. Una revisión pragmática

Health systems do not have the capacity to finance all services. The impact of choosing one option or another is important in order to prioritize health resources. Citizen participation can help to set priorities or to select the interventions that will receive public funding. We reviewed the literature searching for articles that reported mechanisms to gather information about citizens' values or preferences about health system coverage. We identified 363 publications, 18 articles were analyzed in full, and 7 articles were included in the review. Three articles were European, two were from Australia and two from Latin America. The most commonly used mechanisms to gather information were interviews and surveys. We conclude that there is a limited number of articles with examples of tools to capture information about values and preferences in health decision processes. The main barrier observed was the lack of standardized processes to collect the values and preferences of the community.

Brote de fungemias por Sarocladium kiliense en ocho hospitales públicos por contaminación intrínseca de ondansetrón intravenoso / Outbreak of fungemias by Sarocladium kiliense in eight public hospitals per intrinsic contamination of ondansetron intravenous

Resumen Introducción: Sarocladium kiliense es un hongo saprófito que puede generar infecciones oportunistas asociadas a procedimientos invasores. Se informa un brote multicéntrico nosocomial de fungemias de fuente común por este agente. Luego del reporte de cinco casos en pacientes en tres hospitales al Programa de Control de Infecciones del Ministerio de Salud de Chile en julio de 2013, se estudiaron a nivel nacional todos los pacientes con hemocultivo positivo para este agente. Se trató de cuadros clínicos leves a moderados, sin muertes atribuibles. El estudio identificó 65 casos en 8 hospitales, en su mayoría pacientes pediátricos en quimioterapia. Estudios iniciales de 94 muestras de cuatro fármacos y dispositivos usados en todos los casos resultaron negativas hasta que, en un segundo análisis de lotes seleccionados por criterios epidemiológicos y su matriz farmacéutica, se identificó la contaminación intrínseca de ampollas de ondansetrón de un productor específico, que se usó en todos los casos. Se realizó un retiro nacional de las ampollas de los tres lotes contaminados del fármaco, después de lo cual se contuvo el brote. La vigilancia de infecciones en los hospitales y el programa nacional coordinado con los laboratorios de microbiología fueron claves para identificar un brote multicéntrico de fuente común por contaminación de un fármaco por un hongo inusual.

Sarocladium kiliense is a saprophyte fungus that can cause opportunistic infections associated to invasive procedures. We report a multi-hospital nosocomial outbreak of fungemias due to this agent. Patients with positive blood culture to this agent were studied after six bloodstream infections identified in three Chilean hospitals in July 2013 were reported to Ministry of Health National Infection and Prevention Control Program. In general, there were mild clinical manifestations, without deaths attributable to the infection. Epidemiological and micro-biological study identified 65 cases in 8 hospitals, mostly pediatric patients in chemotherapy. Initial studies of 94 different drugs and medical devices had negative results, until a second analysis of specific blisters and their pharmaceutical matrix selected by epidemiological criteria identified an intrinsic contamination of ondansetron blisters from a specific producer used in all the patients. A recall of contaminated ondansetron blisters was performed in all the country, after which the outbreak was contained. Surveillance and response of local and national infection prevention and control programs and laboratory support were key to control of a national multi-hospital common source outbreak due to contamination of a drug by an unusual fungus.

Cómo interpretar guías de práctica clínica elaboradas con metodología GRADE / Clinical guidelines using the GRADE system (Grading of Recommendations Assessment, Development and Evaluation)

The Ministry of Health of Chile, aiming to improve the quality of clinical practice guidelines, gradually incorporated the GRADE system (Grading of Recommendations, Assessment, Development and Evaluation) to develop evidence based recommendations. This system summarizes and evaluates the certainty of the available evidence. It moves from evidence to decision in a systematic and transparent manner, based on four main dimensions: balance between benefits and harms, certainty of evidence, patient's values and preferences and use of resources. The GRADE system produces strong and conditional recommendations. Strong recommendations provide confidence that the favorable consequences of an intervention clearly outweigh the adverse consequences, or vice versa. These recommendations apply to a broad range of patients and circumstances. Conditional recommendations, however, indicate that there is a close balance between favorable and unfavorable consequences of the intervention, there is uncertainty in the magnitude of benefits or adverse effects, there is uncertainty or variability in values and preferences of individuals or costs are not justified. These recommendations apply to many patients, but not all of them: ideally they should be discussed with each person. To achieve a better implementation of the recommendations made with GRADE methodology, health professionals should know the meaning of strong and conditional recommendations and they should be able to critically assess of them.