Implementación del sistema de farmacovigilancia en Laboratorios Dr. A. Bjarner C. A.
Fecha
2021
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Universidad de Guayaquil. Facultad de Ciencias Químicas
Resumen
La importancia de la farmacovigilancia radica en la tenencia de una herramienta que favorece la toma de decisiones para la posesión de una relación riesgo - beneficio sobre los medicamentos. En consecuencia, el presente estudio mantiene como objetivo implementar un sistema de farmacovigilancia en Laboratorios Dr. A. Bjarner C. A. En razón de la metodología, se destaca un enfoque cuantitativo, modalidad observacional y longitudinal, de tipo descriptivo y no experimental. La recolección de datos precede de un checklist y la observación, en conjunto con la descripción del sistema de farmacovigilancia adoptado por la organización. Dentro de los resultados iniciales, se evidenció que el laboratorio farmacéutico únicamente preservaba el 6.9% de cumplimiento acerca de los puntos mínimos que el sistema de farmacovigilancia debe mantener implementado, aportando a esta situación indicadores como la organización y personal (33.3%) y documentación (4.5%); en razón de criterios se destaca el factor crítico con el 17.6%. Posterior a la adopción de mejoras en el sistema de farmacovigilancia, el diagnóstico final determina un cumplimiento general del 83.8%, siendo la organización, personal, capacitación y archivo, indicadores que contribuyeron con el 100% de la posesión de esta realidad. En cuanto a los criterios de evaluación, se enfatiza la presencia de un porcentaje ≥
80% en todos los elementos, predominando con el 83.8% el criterio de carácter
mayor. En conclusión, las mejoras adoptadas en el sistema coadyuvaron en el aumento del nivel de cumplimiento acerca de las pautas estipuladas en la guía de verificación.
The importance of pharmacovigilance lies in the possession of a tool that favors decision-making for the possession of a risk-benefit relationship on drugs. Consequently, the present study maintains the objective of implementing a pharmacovigilance system in Laboratories Dr. A. Bjarner C. A. Due to the methodology, a quantitative approach, an observational and longitudinal modality, of a descriptive and non-experimental type, stands out. Data collection precedes a checklist and observation, together with the description of the pharmacovigilance system adopted by the organization. Among the initial results, it was evidenced that the pharmaceutical laboratory only preserved 6.9% of compliance with the minimum points that the PV system must keep implemented, contributing to this situation indicators such as organization and personnel (33.3%) and documentation (4.5%); In terms of criteria, the critical factor stands out with 17.6%. After the adoption of improvements in the PV system, the final diagnosis determines a general compliance of 83.8%, being the organization and personnel, training and filing, indicators that contributed with 100% of the possession of this reality. Regarding the evaluation criteria, the presence of a percentage ≥ 80% in all the elements is emphasized, with 83.8% predominant in the criterion of a higher nature. In conclusion, the improvements adopted in the system contributed to increasing the level of compliance with the guidelines stipulated in the verification guide.
The importance of pharmacovigilance lies in the possession of a tool that favors decision-making for the possession of a risk-benefit relationship on drugs. Consequently, the present study maintains the objective of implementing a pharmacovigilance system in Laboratories Dr. A. Bjarner C. A. Due to the methodology, a quantitative approach, an observational and longitudinal modality, of a descriptive and non-experimental type, stands out. Data collection precedes a checklist and observation, together with the description of the pharmacovigilance system adopted by the organization. Among the initial results, it was evidenced that the pharmaceutical laboratory only preserved 6.9% of compliance with the minimum points that the PV system must keep implemented, contributing to this situation indicators such as organization and personnel (33.3%) and documentation (4.5%); In terms of criteria, the critical factor stands out with 17.6%. After the adoption of improvements in the PV system, the final diagnosis determines a general compliance of 83.8%, being the organization and personnel, training and filing, indicators that contributed with 100% of the possession of this reality. Regarding the evaluation criteria, the presence of a percentage ≥ 80% in all the elements is emphasized, with 83.8% predominant in the criterion of a higher nature. In conclusion, the improvements adopted in the system contributed to increasing the level of compliance with the guidelines stipulated in the verification guide.
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FARMACOVIGILANCIA, LABORATORIO FARMACÉUTICO, GUÍA DE VERIFICACIÓN, DIAGNÓSTICO, REACCIONES ADVERSAS DE MEDICAMENTOS