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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.
Asunto(s)
Contaminación del Aire Interior , Asma , Compuestos Orgánicos Volátiles , Humanos , Asma/etiología , Asma/epidemiología , Contaminación del Aire Interior/efectos adversos , Compuestos Orgánicos Volátiles/efectos adversos , Exposición a Riesgos Ambientales/efectos adversos , Hipersensibilidad/etiología , Hipersensibilidad/epidemiología , Incidencia , Plaguicidas/efectos adversosRESUMEN
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).
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Contaminación del Aire , Asma , Exposición a Riesgos Ambientales , Humanos , Asma/etiología , Asma/prevención & control , Asma/epidemiología , Contaminación del Aire/efectos adversos , Exposición a Riesgos Ambientales/efectos adversos , Contaminantes Atmosféricos/efectos adversos , Hipersensibilidad/etiología , Hipersensibilidad/epidemiología , Hipersensibilidad/prevención & controlRESUMEN
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.
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OBJECTIVE.: To characterize the adverse events (AEs) related to the off-label use of hydroxychloroquine (HQ), azithromycin (AZI), tocilizumab (TOB) and ivermectin (IVM) for the treatment of COVID-19 in hospitalized patients. MATERIALS AND METHODS.: We conducted a secondary cross-sectional analysis of the Peruvian Social Health Insurance (EsSalud) pharmacovigilance system database of AE notifications to HQ, AZI, TOB and IVM in the Edgardo Rebagliati Martins National Hospital from April to October 2020. Information was collected from digital medical records. We estimated AE reporting rates and evaluated their characteristics by drug type, time of occurrence, type by the affected organ-system, severity and causality. RESULTS.: We identified 154 notifications describing a total of 183 AE possibly related to HQ, AZI, TOB and IVM; the reporting rate was 8%. The median time of AE occurrence was 3 days (IQR: 2-5). Most were cardiovascular events; prolongation of the QT interval was the most frequent. Hepatobiliary AEs were mainly associated with TOB. Most cases were moderate, however, 10.4% were severe. CONCLUSIONS.: We found AEs potentially associated with the use of HQ, AZI, TOB and IVM against COVID-19; cardiovascular events were the most frequent. Although AZI, HQ and IVM have known safety profiles, their use against COVID-19 could increase the occurrence of AE due to the risk factors inherent to this infection. Surveillance systems must be improved, especially those for TOB.
OBJETIVOS.: Caracterizar los eventos adversos (EA) asociados a hidroxicloroquina (HQ), azitromicina (AZI), tocilizumab (TOB) e ivermectina (IVM) prescritos como «fuera de etiqueta¼ 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.
Asunto(s)
COVID-19 , Enfermedades Cardiovasculares , Humanos , Hidroxicloroquina , Azitromicina/efectos adversos , Ivermectina , Estudios Transversales , Perú/epidemiología , Tratamiento Farmacológico de COVID-19 , Seguro de Salud , HospitalesRESUMEN
Los antimicrobianos parenterales son esenciales en el tratamiento de infecciones intrahospitalarias, sin embargo, es importante considerar la carga de sodio y volumen que pueden aportar, especialmente, en pacientes con restricción sódica. En el presente estudio se identificaron los antimicrobianos parenterales usados en uno de los hospitales más grandes del Perú. Se revisó la cantidad de sodio intrínseco y se calculó la cantidad de sodio total por día de tratamiento según el régimen frecuentemente usado en adultos. Como resultado, se encontró que 22% de las terapias antimicrobianas superaban el requerimiento de sodio diario, lo que podría ser perjudicial para pacientes con insuficiencia cardiaca, enfermedad renal crónica, con cirrosis hepática, entre otros.
Parenteral antibiotics are essential in the treatment of nosocomial infections; however, their sodium load and volume should be considered as an extra source, especially, in patients with sodium restriction. In this study, we identified the parental antibiotics used in one of the largest hospitals in Peru. We reviewed the amount of intrinsic sodium and we calculated the sodium load per day of treatment according to the commonly used regimen in adults. As a result, we found that 22% of the antibiotic treatment regimens exceed the daily sodium requirement, which could be harmful for patients with heart failure, chronic kidney disease, liver cirrhosis, among others.
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Humanos , Sodio/análisis , Infusiones Parenterales , Antibacterianos/administración & dosificación , Antibacterianos/química , Hospitalización , Antibacterianos/efectos adversosRESUMEN
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.
Objective. To characterize the adverse events (AEs) related to the off-label use of hydroxychloroquine (HQ), azithromycin (AZI), tocilizumab (TOB) and ivermectin (IVM) for the treatment of COVID-19 in hospitalized patients. Materials and Methods. We conducted a secondary cross-sectional analysis of the Peruvian Social Health Insurance (EsSalud) pharmacovigilance system database of AE notifications to HQ, AZI, TOB and IVM in the Edgardo Rebagliati Martins National Hospital from April to October 2020. Information was collected from digital medical records. We estimated AE reporting rates and evaluated their characteristics by drug type, time of occurrence, type by the affected organ-system, severity and causality. Results. We identified 154 notifications describing a total of 183 AE possibly related to HQ, AZI, TOB and IVM; the reporting rate was 8%. The median time of AE occurrence was 3 days (IQR: 2-5). Most were cardiovascular events; prolongation of the QT interval was the most frequent. Hepatobiliary AEs were mainly associated with TOB. Most cases were moderate, however, 10.4% were severe. Conclusions. We found AEs potentially associated with the use of HQ, AZI, TOB and IVM against COVID-19; cardiovascular events were the most frequent. Although AZI, HQ and IVM have known safety profiles, their use against COVID-19 could increase the occurrence of AE due to the risk factors inherent to this infection. Surveillance systems must be improved, especially those for TOB.
Asunto(s)
Humanos , Masculino , Femenino , Seguro de SaludRESUMEN
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.
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.
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The study aimed to evaluate a group of health professionals' knowledge, attitudes, and practices on pharmacovigilance in the context of COVID-19 in the Peruvian Social Health Insurance (EsSalud). A descriptive secondary analysis was carried out on a database that included responses from an online survey conducted by the Institutional Referral Center for Pharmacovigilance and Technovigilance of EsSalud. Of 144 participants, 66% showed a high level of knowledge and 81.2% had a positive attitude; however, 71.5% had an inadequate level of pharmacovigilance practice. Although EsSalud professionals demonstrated a high level of knowledge and positive attitude to implement pharmacovigilance, this is not reflected in the practice of this activity during the SARS-CoV-2 pandemic. Strategies should be implemented to integrate pharmacovigilance into healthcare activities to benefit patient safety.
El estudio tuvo como objetivo evaluar el conocimiento, las actitudes y prácticas de un grupo de profesionales de la salud sobre la farmacovigilancia en el contexto de la COVID-19 en el Seguro Social de Salud del Perú (EsSalud). Se realizó un análisis secundario descriptivo de una base de datos que incluía las respuestas de una encuesta en línea realizada por el Centro de Referencia Institucional de Farmacovigilancia y Tecnovigilancia de EsSalud. De 144 participantes, el 66% mostró alto nivel de conocimiento y el 81,2%, actitud positiva; sin embargo, el 71,5% tuvo un inadecuado nivel de práctica de farmacovigilancia. Si bien los profesionales de EsSalud demostraron tener alto conocimiento y actitud positiva para implementar farmacovigilancia, esto no se ve reflejado en la práctica de esta actividad en la época de pandemia por el SARS-CoV-2. Se deben emplear estrategias para integrar a la farmacovigilancia en las actividades asistenciales en beneficio de la seguridad del paciente.
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COVID-19 , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos , Actitud del Personal de Salud , Conocimientos, Actitudes y Práctica en Salud , Humanos , Perú/epidemiología , Farmacovigilancia , SARS-CoV-2 , Seguridad Social , Encuestas y CuestionariosRESUMEN
RESUMEN El estudio tuvo como objetivo evaluar el conocimiento, las actitudes y prácticas de un grupo de profesionales de la salud sobre la farmacovigilancia en el contexto de la COVID-19 en el Seguro Social de Salud del Perú (EsSalud). Se realizó un análisis secundario descriptivo de una base de datos que incluía las respuestas de una encuesta en línea realizada por el Centro de Referencia Institucional de Farmacovigilancia y Tecnovigilancia de EsSalud. De 144 participantes, el 66% mostró alto nivel de conocimiento y el 81,2%, actitud positiva; sin embargo, el 71,5% tuvo un inadecuado nivel de práctica de farmacovigilancia. Si bien los profesionales de EsSalud demostraron tener alto conocimiento y actitud positiva para implementar farmacovigilancia, esto no se ve reflejado en la práctica de esta actividad en la época de pandemia por el SARS-CoV-2. Se deben emplear estrategias para integrar a la farmacovigilancia en las actividades asistenciales en beneficio de la seguridad del paciente.
ABSTRACT The study aimed to evaluate a group of health professionals' knowledge, attitudes, and practices on pharmacovigilance in the context of COVID-19 in the Peruvian Social Health Insurance (EsSalud). A descriptive secondary analysis was carried out on a database that included responses from an online survey conducted by the Institutional Referral Center for Pharmacovigilance and Technovigilance of EsSalud. Of 144 participants, 66% showed a high level of knowledge and 81.2% had a positive attitude; however, 71.5% had an inadequate level of pharmacovigilance practice. Although EsSalud professionals demonstrated a high level of knowledge and positive attitude to implement pharmacovigilance, this is not reflected in the practice of this activity during the SARS-CoV-2 pandemic. Strategies should be implemented to integrate pharmacovigilance into healthcare activities to benefit patient safety.
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Humanos , Masculino , Femenino , Personal de Salud , Farmacovigilancia , COVID-19 , Conocimientos, Actitudes y Práctica en Salud , Atención a la Salud , Seguro de SaludRESUMEN
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.
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Introducción: La carmustina es un agente antineoplásico alquilante utilizado en el tratamiento de mielomas, linfomas y otros tipos de cáncer. La cardiotoxicidad por carmustina es una reacción adversa muy rara, por lo que debe ser identificada oportunamente para prevenir desenlaces fatales. Reporte de caso: Se presenta un caso inusual de una paciente con cardiotoxicidad aguda grave reversible posterior a la administración endovenosa de carmustina. Al suspenderla exposición a este producto e iniciar tratamiento sintomatológico, la paciente se recupera satisfactoriamente sin nueva manifestación cardiaca. El caso fue notificado como reacción adversa medicamentosa y al evaluarse la causalidad entre la cardiotoxicidad y la carmustina, resultó probable (puntaje final =7). Conclusiones: El presente caso puede ser considerado una señal en farmacovigilancia, por lo que, los clínicos deben ser conscientes del riesgo potencial de cardiotoxicidad en pacientes expuestos a carmustina. Se recomienda realizar farmacovigilancia activa a los fármacos oncológicos.
Background: Carmustine is an alkylating agent used in the treatment of myeloma, lymphomas and other cancers. Cardiotoxicity due to carmustine is a rare adverse reaction that must be identified early to prevent fatal outcomes. Report case: We present an unusual case of acute cardiac toxicity related to the intravenous administration of carmustine. After stopping the carmustine, patient received symptomatic treatment and, finally was fully recovered. The case was reported as adverse drug reaction and we performed a pharmacovigilance causality assessment between carmustine and cardiotoxicity, resulting in probable (final score = 7). Conclusions: This case might be considered as a signal in pharmacovigilance. Clinicians should be aware of the potential risk of cardiotoxicity in patients exposed to carmustine. It is recommended to implement active pharmacovigilance to chemotherapy.