Trombocitopenia severa inducida por un oclusor para DAP: reporte de caso en tecnovigilancia.

Introduction: Patent ductus arteriosus (PDA) is a congenital heart condition of special interest. Interventional occlusion is the treatment of choice; however, a PDA occlude, used in this procedure, is a medical device that rarely could lead to adverse events such as hemorrhage, thrombocytopenia, etc. Case report: We present a case of a pediatric patient with severe thrombocytopenia after surgery. During her hospitalization, platelet levels remained lower and, finally, she was fully recovered without any hematological manifestation. The case was reported as a suspected adverse incident related to PDA occlude. Conclusion: After performing a cause-root analysis, we concluded that the size of the PDA occlude may be the main cause of thrombocytopenia.  This case demonstrates that medical devices could lead to adverse events. Thus, it is important for clinicians to implement medical device surveillance, mainly for high-risk medical devices.Introducción: El ductus arterioso persistente (DAP) es una cardiopatía congénita de especial interés. La oclusión intervencionista es el tratamiento de elección, no obstante, el dispositivo médico “oclusor para DAP”, usado en este procedimiento, puede dar lugar a la aparición de eventos adversos de rara frecuencia como hemorragia, trombocitopenia, entre otros. Reporte de caso: Se presenta un caso de una paciente pediátrica con trombocitopenia severa posterior a la intervención. Durante su hospitalización, la paciente mantuvo niveles bajos de plaquetas hasta que logra su recuperación y sale de alta sin una nueva manifestación hematológica. El caso fue reportado como sospecha de incidente adverso asociada al oclusor para DAP. Conclusión: Al realizarse el análisis causa-raíz, se concluye que el tamaño del oclusor para DAP podría ser la principal causa de la trombocitopenia. El presente caso es una muestra que los dispositivos médicos pueden causar eventos adversos severos, por lo que, es necesaria la implementación de tecnovigilancia, principalmente a los dispositivos médicos de alto riesgo

Caracterización de los eventos adversos a hidroxicloroquina, ivermectina, azitromicina y tocilizumab en pacientes hospitalizados por la COVID-19 en un hospital del Seguro Social de Salud del Perú

Objetivos. Caracterizar los eventos adversos (EA) asociados a hidroxicloroquina (HQ), azitromicina (AZI), tocilizumab (TOB) e ivermectina (IVM) prescritos como «fuera de etiqueta» en el tratamiento de pacientes hospitalizados por la COVID-19. Materiales y métodos. Se realizó un análisis secundario transversal de la base de datos del sistema de farmacovigilancia del Seguro Social de Salud del Perú (EsSalud) de las notificaciones de EA a HQ, AZI, TOB e IVM provenientes del Hospital Nacional Edgardo Rebagliati Martins de abril a octubre del 2020. Se revisaron las historias clínicas digitales, se estimaron las tasas de reporte de EA y se evaluaron sus características por tipo de fármaco, tiempo de aparición, tipo por órgano-sistema afectado, gravedad y causalidad. Resultados. Se identificaron 154 notificaciones que describen un total de 183 EA posiblemente relacionados con HQ, AZI, TOB e IVM, siendo 8% la tasa de reporte de EA. La mediana de tiempo de aparición de EA fue de 3 días (RIC: 2–5). La mayoría fueron cardiovasculares, destacándose la prolongación del intervalo QT. Se observaron EA hepatobiliares principalmente asociados a TOB. La mayoría de los casos fueron moderados, no obstante, el 10,4% fue grave. Conclusiones. Se identificaron EA potencialmente asociados al uso de HQ, AZI, TOB e IVM contra la COVID-19, siendo los más frecuentes los de tipo cardiovasculares. A pesar de que la AZI, HQ e IVM poseen perfiles conocidos de seguridad, su empleo en la COVID-19 podría incrementar la aparición de EA por los factores de riesgo propios de esta infección. Se sugiere reforzar la vigilancia, especialmente, de TOB

Drug utilization research in Peru: Is real-world data available?

Background: Drug utilization research (DUR) is used to provide evidence-based data to inform policies and make decisions. The aim of this study was to map and describe available data sources for drug utilization research in Peru.Methods: We performed a search of data sources providing information on medication use on the website of governmental organizations. We also conducted a literature review using PubMed, LILACs, and BVS. Independently, researchers screened eligible data sources. Data characterization included accessibility, coverage data provider, type of data sources, and setting. We performed a descriptive analysis.Results: We identified seven data sources, CENAFyT, ICI, IDI (SISMED), and ENSUSALUD from MINSA, and CRI-ESSALUD, SGSS/ESSI, and ENSSA from ESSALUD. These presented information on adverse drug reactions (n = 2), drug consumption, and distribution (n = 2), prescription and drug dispensing (n = 1), and surveys addressed to medication users (n = 2). ENSUSALUD was the only data source publicly available. VIGIFLOW and ENSUSALUD have a national granularity from the public and private sectors. The setting of the data sources was both hospital and ambulatory care. Two data sources have individual-level data on adverse drug reactions and one on prescriptions. Four studies on drug utilization research in Peru were derived from ENSUSALUD.Conclusion: In Peru, few data sources are available for drug utilization research. There is an increased need to monitor medications for decision-making purposes. Local and international initiatives and partnerships of the government with academic institutions and the private sector might be a good strategy to increase the transparency of health data and for supporting decision-making using drug utilization research

Presentation1_Drug utilization research in Peru: Is real-world data available?.pdf

Background: Drug utilization research (DUR) is used to provide evidence-based data to inform policies and make decisions. The aim of this study was to map and describe available data sources for drug utilization research in Peru.Methods: We performed a search of data sources providing information on medication use on the website of governmental organizations. We also conducted a literature review using PubMed, LILACs, and BVS. Independently, researchers screened eligible data sources. Data characterization included accessibility, coverage data provider, type of data sources, and setting. We performed a descriptive analysis.Results: We identified seven data sources, CENAFyT, ICI, IDI (SISMED), and ENSUSALUD from MINSA, and CRI-ESSALUD, SGSS/ESSI, and ENSSA from ESSALUD. These presented information on adverse drug reactions (n = 2), drug consumption, and distribution (n = 2), prescription and drug dispensing (n = 1), and surveys addressed to medication users (n = 2). ENSUSALUD was the only data source publicly available. VIGIFLOW and ENSUSALUD have a national granularity from the public and private sectors. The setting of the data sources was both hospital and ambulatory care. Two data sources have individual-level data on adverse drug reactions and one on prescriptions. Four studies on drug utilization research in Peru were derived from ENSUSALUD.Conclusion: In Peru, few data sources are available for drug utilization research. There is an increased need to monitor medications for decision-making purposes. Local and international initiatives and partnerships of the government with academic institutions and the private sector might be a good strategy to increase the transparency of health data and for supporting decision-making using drug utilization research.</p

Biosimilars approvals by thirteen regulatory authorities: A cross-national comparison

Biosimilars are biological medicines highly similar to a previously licensed reference product and their licensing is expected to improve access to biological therapies. This study aims to present an overview of biosimilars approval by thirteen regulatory authorities (RA). The study is a cross-national comparison of regulatory decisions involving biosimilars in Argentina, Australia, Brazil, Chile, Canada, Colombia, Europe, Hungary, Guatemala, Italy, Mexico, Peru and United States. We examined publicly available documents containing information regarding the approval of biosimilars and investigated the publication of public assessment reports for registration applications, guidelines for biosimilars licensing, and products approved. Data extraction was conducted by a network of researchers and regulatory experts. All the RA had issued guidance documents establishing the requirements for the licensing of biosimilars. However, only three RA had published public assessment reports for registration applications. In total, the investigated jurisdictions had from 19 to 78 biosimilars approved, most of them licensed from 2018 to 2020. In spite of the advance in the number of products in recent years, some challenges still persist. Limited access to information regarding the assessment of biosimilars by RA can affect confidence, which may ultimately impact adoption of these products in practice.Fil: Machado, Fernanda Lacerda da Silva. Universidade Federal do Rio de Janeiro; BrasilFil: Cañás, Martín. Universidad Nacional Arturo Jauretche; ArgentinaFil: Doubova, Svetlana V.. Mexican Institute Of Social Security; MéxicoFil: Urtasun, Martín Alejandro. Universidad Nacional Arturo Jauretche; ArgentinaFil: Marin, Gustavo Horacio. Universidad Nacional de La Plata; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; ArgentinaFil: Osorio de Castro, Claudia Garcia Serpa. Instituto Oswaldo Cruz; BrasilFil: Albuquerque, Flavia Caixeta. Sorocaba University; BrasilFil: Ribeiro, Tatiane Bonfim. Universidade de Sao Paulo; BrasilFil: Pont, Lisa. University of Technology Sydney; AustraliaFil: Crisóstomo Landeros, José. Instituto de Salud Pública de Chile; ChileFil: Roldán Saelzer, Juan. Instituto de Salud Pública de Chile; ChileFil: Sepúlveda Viveros, Dino. Universidad del Desarrollo; Chile. Universidad Autónoma de Chile; ChileFil: Acosta, Angela. Universidad Icesi; ColombiaFil: Machado Beltrán, Manuel A.. Universidad Nacional de Colombia; ColombiaFil: Gordillo Alas, Lily Iracema. Ministry of Public Health and Social Assistance; GuatemalaFil: Orellana Tablas, Lourdes Abigail. Ministry of Public Health and Social Assistance; GuatemalaFil: Benko, Ria. University of Szeged; HungríaFil: Convertino, Irma. University of Pisa; ItaliaFil: Bonaso, Marco. University of Pisa; ItaliaFil: Tuccori, Marco. University of Pisa; ItaliaFil: Kirchmayer, Ursula. Lazio Regional Health Service; ItaliaFil: Contreras Sánchez, Saúl E.. Mexican Institute of Social Security; MéxicoFil: Rodríguez Tanta, L. Yesenia. Universidad Cientifica del Sur;Fil: Gutierrez Aures, Ysabel. Ministry of Health of Peru; PerúFil: Lin, Boya. University of Florida; Estados UnidosFil: Alipour Haris, Golnoosh. University of Florida; Estados UnidosFil: Eworuke, Efe. Real World Solutions; Estados UnidosFil: Lopes, Luciane Cruz. Sorocaba University; Brasi

An overview of biosimilars approvals by thirteen regulatory authorities: A cross national comparison

Biosimilars are biological medicines highly similar to a previously licensed reference product and their licensing is expected to improve access to biological therapies. This study aims to present an overview of biosimilars approval by thirteen regulatory authorities (RA). The study is a cross-national comparison of regulatory decisions involving biosimilars in Argentina, Australia, Brazil, Chile, Canada, Colombia, Europe, Hungary, Guatemala, Italy, Mexico, Peru and United States. We examined publicly available documents containing information regarding the approval of biosimilars and investigated the publication of public assessment reports for registration applications, guidelines for biosimilars licensing, and products approved. Data extraction was conducted by a network of researchers and regulatory experts. All the RA had issued guidance documents establishing the requirements for the licensing of biosimilars. However, only three RA had published public assessment reports for registration applications. In total, the investigated jurisdictions had from 19 to 78 biosimilars approved, most of them licensed from 2018 to 2020. In spite of the advance in the number of products in recent years, some challenges still persist. Limited access to information regarding the assessment of biosimilars by RA can affect confidence, which may ultimately impact adoption of these products in practice.Facultad de Ciencias Médica

The impact of outdoor pollution and extreme temperatures on asthma-related outcomes: a systematic review for the EAACI guidelines on environmental science for allergic diseases and asthma

Air pollution is one of the biggest environmental threats for asthma. Its impact is augmented by climate change. To inform the recommendations of the EAACI Guidelines on the environmental science for allergic diseases and asthma, a systematic review (SR) evaluated the impact on asthma-related outcomes of short-term exposure to outdoor air pollutants (PM2.5, PM10, NO2, SO2, O3, and CO), heavy traffic, outdoor pesticides, and extreme temperatures. Additionally, the SR evaluated the impact of the efficacy of interventions reducing outdoor pollutants. The risk of bias was assessed using ROBINS-E tools and the certainty of the evidence by using GRADE. Short-term exposure to PM2.5, PM10, and NO2 probably increases the risk of asthma-related hospital admissions (HA) and emergency department (ED) visits (moderate certainty evidence). Exposure to heavy traffic may increase HA and deteriorate asthma control (low certainty evidence). Interventions reducing outdoor pollutants may reduce asthma exacerbations (low to very low certainty evidence). Exposure to fumigants may increase the risk of new-onset asthma in agricultural workers, while exposure to 1,3-dichloropropene may increase the risk of asthma-related ED visits (low certainty evidence). Heatwaves and cold spells may increase the risk of asthma-related ED visits and HA and asthma mortality (low certainty evidence).</p

The impact of indoor pollution on asthma-related outcomes: a systematic review for the EAACI guidelines on environmental science for allergic diseases and asthma

Systematic review using GRADE of the impact of exposure to volatile organic compounds (VOCs), cleaning agents, mould/damp, pesticides on the risk of (i) new-onset asthma (incidence) and (ii) adverse asthma-related outcomes (impact). MEDLINE, EMBASE and Web of Science were searched for indoor pollutant exposure studies reporting on new-onset asthma and critical and important asthma-related outcomes. Ninety four studies were included: 11 for VOCs (7 for incidenceand 4 for impact), 25 for cleaning agents (7 for incidenceand 8 for impact), 48 for damp/mould (26 for incidence and 22 for impact) and 10 for pesticides (8 for incidence and 2 for impact). Exposure to damp/mould increases the risk of new-onset wheeze (moderate certainty evidence). Exposure to cleaning agents may be associated with a higher risk of new-onset asthma and with asthma severity (low level of certainty). Exposure to pesticides and VOCs may increase the risk of new-onset asthma (very low certainty evidence). The impact on asthma-related outcomes of all major indoor pollutants is uncertain. As the level of certainty is low or very low for most of the available evidence on the impact of indoor pollutants on asthma-related outcomes more rigorous research in the field is warranted.</p