Propuesta de procedimientos operativos estándar para el sistema de Buenas Prácticas de Farmacovigilancia en una droguería peruana
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Date
2024
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Universidad Nacional de Trujillo
Abstract
El presente informe de tesis tiene como objetivo la creación para la posterior implementación de procedimientos operativos estándar (POE) en cumplimiento con el Manual de Buenas Prácticas de Farmacovigilancia del Perú aprobado en la Resolución Ministerial Nro. 1053-2020/MINSA para una droguería titular de registro de sanitario (TRS). Se desarrolló una lista maestra con doce (12) procedimientos donde se indican sus títulos y codificación correspondiente. Luego se procedió a elaborar cada uno de los POE detallando cada etapa y teniendo en cuenta lo indicado en el manual de buenas practicas y lo que indica para las droguerías que son titulares de registro sanitario, para que su ves pueda ser socializado y ejecutado por todo el personal que labore en la droguería. Se completaron estos procedimientos con la creación de formatos que apoyan al registro y evaluación constante del sistema de farmacovigilancia de las droguerías, estableciendo quien debe registrar en ellos para poder obtener los datos de farmacovigilancia de los medicamentos de los cuales la droguería es titular de registro sanitario. Con estos documentos nos aseguramos de que la droguería titular de registro sanitario comercialice productos farmacéuticos seguros, para que luego los pacientes puedan ser administrados con estos son problemas de salud alguna, y de ser el caso, la autoridad nacional pueda tomar las acciones pertinentes
ABSTRACT The objective of this thesis report is the creation for the subsequent implementation of standard operating procedures (SOP) in compliance with the Peruvian Manual of Good Pharmacovigilance Practices approved in Ministerial Resolution No. 1053-2020/MINSA for a drugstore with sanitary registration. A master list was developed with twelve (12) procedures indicating their titles and corresponding coding. Then, each of the SOPs was prepared, detailing each stage and taking into account what is indicated in the manual of good practices and what is indicated for drugstores that are holders of sanitary registration, so that they can be socialized and executed by all the personnel working in the drugstore. These procedures were completed with the creation of formats that support the registration and constant evaluation of the pharmacovigilance system of the drugstores, establishing who must register in them in order to obtain the pharmacovigilance data of the drugs for which the drugstore is a sanitary registration holder. With these documents we ensure that the drugstore holder of sanitary registration markets safe pharmaceutical products, so that patients can be administered with these products without any health problems, and if necessary, the national authority can take the appropriate actions.
ABSTRACT The objective of this thesis report is the creation for the subsequent implementation of standard operating procedures (SOP) in compliance with the Peruvian Manual of Good Pharmacovigilance Practices approved in Ministerial Resolution No. 1053-2020/MINSA for a drugstore with sanitary registration. A master list was developed with twelve (12) procedures indicating their titles and corresponding coding. Then, each of the SOPs was prepared, detailing each stage and taking into account what is indicated in the manual of good practices and what is indicated for drugstores that are holders of sanitary registration, so that they can be socialized and executed by all the personnel working in the drugstore. These procedures were completed with the creation of formats that support the registration and constant evaluation of the pharmacovigilance system of the drugstores, establishing who must register in them in order to obtain the pharmacovigilance data of the drugs for which the drugstore is a sanitary registration holder. With these documents we ensure that the drugstore holder of sanitary registration markets safe pharmaceutical products, so that patients can be administered with these products without any health problems, and if necessary, the national authority can take the appropriate actions.
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Keywords
Procedimientos Operativos Estándar (POE), Buenas Prácticas de Distribución y Transporte