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Cuestionario en línea para el estudio de postcomercialización del PrevengHo® Vir utilizado contra la COVID-19.

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Title: Cuestionario en línea para el estudio de postcomercialización del PrevengHo® Vir utilizado contra la COVID-19.
Alternate Title: Online questionnaire for the post-marketing study of PrevengHo® Vir used against COVID-19.
Authors: Burguet Lago, Nancy1 nburguet@aica.cu, Burguet Lago, Ivonne2 iburguet@uci.cu
Source: Revista CENIC Ciencias Biologicas. Jan-May2021, Vol. 52 Issue 1, p1-10. 10p.
Subjects: HOMEOPATHIC agents, COVID-19 pandemic, AICA Laboratories (Company), INTERNET questionnaires, PHARMACEUTICAL industry, MEDICATION safety, PUBLIC health
Geographic Terms: CUBA
Abstract (English): The pharmaceutical industry is the maximum responsible for the protection of the health of users by being able to detect early some unexpected manifestations that would alter the risk-benefit balance in the application of a product to the population. The AICA Laboratories Company recently registered a new homeopathic medicine PrevengHo® Vir, which is being used by Cuban Public Health in the fight against COVID-19. Based on the fact that pharmacovigilance is a shared activity between health personnel, the National Regulatory Authority, the pharmaceutical industry and patients and considering the framework of social isolation due to the COVID-19 pandemic, in which the study will be carried out post-marketing of the PrevengHo® Vir product; The objective of this study is to validate an online questionnaire by consulting a specialist as an alternative that facilitates the post-marketing study of PrevengHo® Vir, which is manufactured in the Julio Trigo UEB, belonging to the AICA Laboratories Company of BioCubaFarma. The experiential method is used to characterize the current state of Pharmacovigilance in the company. The systematization, the documentary analysis for the proposal of the content of the questionnaire and the consultation of specialists to assess the viability of the proposed questionnaire, from the statistics, the non-parametric Chi-square test of goodness of fit (mode) was applied to know the level of significance of the opinion of the specialists. Results: the online questionnaire proposed and its viability validated by specialists' criteria will allow the collection of information on the safety of the use of PrevengHo® Vir. The validation by the specialists of the online questionnaire will allow its subsequent application for the constant evaluation of this product from the perspective of people, the community and society. [ABSTRACT FROM AUTHOR]
Abstract (Spanish): La industria farmacéutica es la máxima responsable de la protección de la salud de los usuarios al poder detectar de manera precoz algunas manifestaciones inesperadas que alterarían el balance riesgo-beneficio en la aplicación de un producto a la población. La Empresa Laboratorios AICA, recientemente, registró un nuevo medicamento homeopático PrevengHo® Vir, que se está empleando por la Salud Pública cubana en la lucha contra la COVID-19. A partir del hecho de que la farmacovigilancia es una actividad compartida entre el personal de salud, la Autoridad Reguladora Nacional, la industria farmacéutica y los pacientes y considerando el marco de aislamiento social por la pandemia del COVID-19, en que se realizará el estudio de postcomercialización del producto PrevengHo® Vir. El objetivo del presente trabajo consiste en validar mediante la consulta a especialista un cuestionario en línea como alternativa que facilite el estudio de postcomercialización del PrevengHo® Vir que se fabrica en la UEB Julio Trigo, perteneciente a la Empresa Laboratorios AICA de BioCubaFarma. Se emplea el método vivencial para caracterizar el estado actual de la Farmacovigilancia en la empresa. La sistematización, el análisis documental para la propuesta del contenido del cuestionario y la consulta a especialistas para la valoración de la viabilidad del cuestionario propuesto, desde la estadística se aplicó la prueba no paramétrica Chi-cuadrada de bondad de ajuste (moda) para conocer el nivel de significatividad de la opinión de los especialistas. El cuestionario en línea propuesto y validado su viabilidad por criterio de especialistas permitirá la recopilación de información sobre la seguridad del uso de PrevengHo® Vir. La validación por los especialistas del cuestionario en línea permitirá su posterior aplicación para la evaluación constante de este producto desde la perspectiva de las personas, la comunidad y la sociedad. [ABSTRACT FROM AUTHOR]
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Database: MedicLatina
Description
Abstract:The pharmaceutical industry is the maximum responsible for the protection of the health of users by being able to detect early some unexpected manifestations that would alter the risk-benefit balance in the application of a product to the population. The AICA Laboratories Company recently registered a new homeopathic medicine PrevengHo® Vir, which is being used by Cuban Public Health in the fight against COVID-19. Based on the fact that pharmacovigilance is a shared activity between health personnel, the National Regulatory Authority, the pharmaceutical industry and patients and considering the framework of social isolation due to the COVID-19 pandemic, in which the study will be carried out post-marketing of the PrevengHo® Vir product; The objective of this study is to validate an online questionnaire by consulting a specialist as an alternative that facilitates the post-marketing study of PrevengHo® Vir, which is manufactured in the Julio Trigo UEB, belonging to the AICA Laboratories Company of BioCubaFarma. The experiential method is used to characterize the current state of Pharmacovigilance in the company. The systematization, the documentary analysis for the proposal of the content of the questionnaire and the consultation of specialists to assess the viability of the proposed questionnaire, from the statistics, the non-parametric Chi-square test of goodness of fit (mode) was applied to know the level of significance of the opinion of the specialists. Results: the online questionnaire proposed and its viability validated by specialists' criteria will allow the collection of information on the safety of the use of PrevengHo® Vir. The validation by the specialists of the online questionnaire will allow its subsequent application for the constant evaluation of this product from the perspective of people, the community and society. [ABSTRACT FROM AUTHOR]
ISSN:02535688