PERFIL DE SEGURIDAD DEL USO DE UN ANTICOAGULANTE EN PACIENTES GERIÁTRICOS MAYORES DE 65 AÑOS.

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Bibliographic Details
Title:	PERFIL DE SEGURIDAD DEL USO DE UN ANTICOAGULANTE EN PACIENTES GERIÁTRICOS MAYORES DE 65 AÑOS.
Alternate Title:	SAFETY PROFILE OF THE USE OF AN ANTICOAGULANT IN GERIATRIC PATIENTS OLDER THAN 65 YEARS.
Authors:	Burguet Lago, Nancy¹ nburguet@aica.cu, Troche Concepción, Yenilen¹
Source:	Revista CENIC Ciencias Biologicas. 2023, Vol. 54, p112-121. 10p.
Subjects:	HEPARIN, MYOCARDIAL ischemia, CORONARY disease, ESSENTIAL drugs, ANGINA pectoris, OLDER patients, MEDICATION safety, WORLD Health Organization, LABORATORIOS AICA (Company), MYOCARDIAL infarction, CHRONIC kidney failure, RODENTICIDES
Geographic Terms:	SANTIAGO de Cuba (Cuba), CUBA
Abstract (English):	Sodium Heparin 5000UI/mL, is an anticoagulant medication for the exclusive use of hospitals that is widely used in the world. The World Health Organization includes it in a list of essential drugs, stating that a year it helps to save more 100 million life. In Cuba, the AICA+ Laboratory Company is the owner of this medicine, so it is of interest to know the safety profile of the use of this anticoagulant in geriatric patients over 65 years of age, this being the objective of this work. An observational, descriptive and cross-sectional study of case series was carried out. Through spontaneous notifications, from 2018 to 2022. The universe included 13 patients over 65 years of age. The type of event, affected organ systems, patient sex, pathological history, route, dose of administration, reason for medical prescription, time sequence, personnel reporting, level of care where they appeared, region of the country where they manifested, were analyzed. They were classified in severity, causality and frequency. 32.5% adverse events were reported in patients with bleeding as the main event, skin as the most affected organ system, males predominating, carriers of ischemic heart disease, arterial hypertension, and chronic kidney disease. The most widely used route of administration is intravenous in cyclical or daily doses of 5,000 IU to 30,000 IU, given for unstable angina, thromboembolic disease, anticoagulant, hemodialysis, bleeding, and myocardial infarction, with symptoms in the first 24 hours of treatment, mostly reported by physicians since the secondary level of health. Santiago de Cuba reported the highest number of cases. Most of the adverse events were classified as moderate, possible and frequent, only one patient showed a serious adverse effect with a favorable outcome for life. As a conclusion, we can state that sodium Heparin 5000UI/mL, at the time under study, turned out to be a safe product for geriatric patients over 65 years of age. [ABSTRACT FROM AUTHOR]
Abstract (Spanish):	La Heparina sódica 5000UI/mL, es un medicamento anticoagulante de uso exclusivo de hospitales de amplio uso en el mundo, la Organización Mundial de la Salud, lo incluye en un listado de fármacos de primera necesidad, al referir que al año ayuda a salvar más de 100 millones de vida. En Cuba, la Empresa Laboratorio AICA+ es titular de este medicamento, por lo que es de su interés conocer el perfil de seguridad del uso de este anticoagulante en pacientes geriátricos mayores de 65 años, siendo este el objetivo del presente trabajo. Se realizó un estudio observacional, descriptivo y transversal de serie de casos. A través de notificaciones espontáneas, desde el 2018 hasta 2022. El universo incluyó 13 pacientes con más de 65 años. Se analizó tipo de evento, sistemas de órganos afectados, sexo del paciente, antecedentes patológicos, vía, dosis de administración, motivo de prescripción médica, secuencia temporal, personal que notifica, nivel de atención donde aparecieron, región del país donde se manifestaron. Se clasificaron en severidad, causalidad y frecuencia. Se notificaron 32,5% eventos adversos en pacientes con sangramientos como evento principal, la piel como sistema de órgano más afectado, predominó el sexo masculino, portadores de cardiopatía isquémica, hipertensión arterial y enfermedad renal crónica. Vía de administración más utilizada intravenosa en dosis cíclica o diaria de 5000UI hasta 30000UI, suministrada por angina inestable, enfermedad tromboembólica, anticoagulante, hemodiálisis, sangramientos e infarto del miocardio, con síntomas en las primeras 24h del tratamiento, notificadas en su mayoría por médicos desde el nivel secundario de salud. Santiago de Cuba comunicó el mayor número de casos. Los eventos adversos en su mayoría clasificaron como, moderados, posible y frecuentes, solo un paciente mostró efecto adverso grave con desenlace favorable para la vida. A modo de conclusión podemos plantear que la Heparina sódica5000UI/mL, en el tiempo objeto de estudio resultó ser un producto seguro para pacientes geriátricos de más de 65 años. [ABSTRACT FROM AUTHOR]
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Database:	MedicLatina

Description
Abstract:	Sodium Heparin 5000UI/mL, is an anticoagulant medication for the exclusive use of hospitals that is widely used in the world. The World Health Organization includes it in a list of essential drugs, stating that a year it helps to save more 100 million life. In Cuba, the AICA+ Laboratory Company is the owner of this medicine, so it is of interest to know the safety profile of the use of this anticoagulant in geriatric patients over 65 years of age, this being the objective of this work. An observational, descriptive and cross-sectional study of case series was carried out. Through spontaneous notifications, from 2018 to 2022. The universe included 13 patients over 65 years of age. The type of event, affected organ systems, patient sex, pathological history, route, dose of administration, reason for medical prescription, time sequence, personnel reporting, level of care where they appeared, region of the country where they manifested, were analyzed. They were classified in severity, causality and frequency. 32.5% adverse events were reported in patients with bleeding as the main event, skin as the most affected organ system, males predominating, carriers of ischemic heart disease, arterial hypertension, and chronic kidney disease. The most widely used route of administration is intravenous in cyclical or daily doses of 5,000 IU to 30,000 IU, given for unstable angina, thromboembolic disease, anticoagulant, hemodialysis, bleeding, and myocardial infarction, with symptoms in the first 24 hours of treatment, mostly reported by physicians since the secondary level of health. Santiago de Cuba reported the highest number of cases. Most of the adverse events were classified as moderate, possible and frequent, only one patient showed a serious adverse effect with a favorable outcome for life. As a conclusion, we can state that sodium Heparin 5000UI/mL, at the time under study, turned out to be a safe product for geriatric patients over 65 years of age. [ABSTRACT FROM AUTHOR]
ISSN:	02535688