Pertinencia de la formulación y producción de desinfectantes para manos comercializados durante la COVID-19 en cuatro municipios de Villa Clara
Fecha
2021
Autores
Alonso Arteaga, Daniela
Título de la revista
ISSN de la revista
Título del volumen
Editor
Universidad Central ¨Marta Abreu¨ de Las Villas. Facultad de Química y Farmacia. Departamento de Farmacia
Resumen
La eficacia, seguridad y sostenibilidad de los desinfectantes de manos (ABHR, por sus siglas en inglés), empleados como medida preventiva frente al SARS-CoV-2, deben estar respaldados por evidencia científica. Objetivo: Valorar el grado de cumplimiento de las exigencias nacionales e internaciones para los desinfectantes de manos, elaborados en los Centros de Producción Local (CPLs) de la Unidad Empresarial de Base Farmacias y Ópticas de Caibarién, en el contexto de la COVID-19. Materiales y métodos: Se realizó un estudio descriptivo, transversal, observacional y retrospectivo, que involucró la recolección de datos sobre documentos oficiales y registros de producción de las formulaciones elaboradas en cuatro CPLs de Villa Clara en 2020 y 2021. Se seleccionó como patrón de referencia la formulación con etanol recomendada por la Organización Mundial de la Salud (OMS). Resultados: Las formulaciones de ABHR son pertinentes, en lo fundamental, en cuanto a sus componentes, efectividad de los mismos frente al SARS-CoV-2, requisitos de calidad y tipo de producto final en que se presentan. Los métodos de preparación, ensayos para el control de la calidad y período de vida útil asignado, no satisfacen totalmente las regulaciones nacionales e internacionales. Se propusieron acciones concretas en respuesta a estas exigencias. Conclusiones: Se deben aplicar las acciones recomendadas para que los ABHRs estudiados satisfagan completamente las exigencias de las agencias reguladoras de medicamentos en Cuba y los Estados Unidos (EU) y las recomendaciones de la OMS.
The efficacy, safety and sustainability of hand sanitizers (ABHR), used as a preventive measure against SARS-CoV-2, must be supported by scientific evidence. Objective: To assess the degree of compliance with national and international requirements for hand sanitizers, made in the Local Production Centers (LPCs) of the “Unidad Empresarial de Base Farmacias y Ópticas de Caibarién”, in the context of COVID-19. Materials and methods: A descriptive, cross-sectional, observational and retrospective study was carried out, which involved the collection of data on official documents and production records of the formulations made in four Villa Clara LPCs in 2020 and 2021. It was selected as the reference standard the formulation with ethanol recommended by the World Health Organization (WHO). Results: ABHR formulations are fundamentally relevant in terms of their components, their effectiveness against SARS-CoV-2, quality requirements and type of final product in which they are presented. The preparation methods, quality control tests and the assigned shelf life do not fully satisfy national and international regulations. Concrete actions were proposed in response to these demands. Conclusions: The recommended actions should be applied so that the ABHRs studied fully satisfy the requirements of the drug regulatory agencies in Cuba and the United States (US) and the WHO recommendations.
The efficacy, safety and sustainability of hand sanitizers (ABHR), used as a preventive measure against SARS-CoV-2, must be supported by scientific evidence. Objective: To assess the degree of compliance with national and international requirements for hand sanitizers, made in the Local Production Centers (LPCs) of the “Unidad Empresarial de Base Farmacias y Ópticas de Caibarién”, in the context of COVID-19. Materials and methods: A descriptive, cross-sectional, observational and retrospective study was carried out, which involved the collection of data on official documents and production records of the formulations made in four Villa Clara LPCs in 2020 and 2021. It was selected as the reference standard the formulation with ethanol recommended by the World Health Organization (WHO). Results: ABHR formulations are fundamentally relevant in terms of their components, their effectiveness against SARS-CoV-2, quality requirements and type of final product in which they are presented. The preparation methods, quality control tests and the assigned shelf life do not fully satisfy national and international regulations. Concrete actions were proposed in response to these demands. Conclusions: The recommended actions should be applied so that the ABHRs studied fully satisfy the requirements of the drug regulatory agencies in Cuba and the United States (US) and the WHO recommendations.
Descripción
Palabras clave
Comercialización de Productos, Desinfectantes de Manos (ABHR), COVID-19