Quality of the FarmaVigiC database filling process, Las Tunas 2021

Abstract

Background: the correct filling of the FarmaVigiC pharmacovigilance database from the adverse reaction notification model determines its proper interpretation for therapeutic decision-making in clinical practice. Objective: characterize the filling of the pharmacovigilance database from the reporting model of adverse drug reactions in the year 2021 in Las Tunas. Methods: a descriptive cross-sectional study was carried out with the afore mentioned objective, place and period of time. The sample consisted of the 1235 notifications of adverse reactions registered in the FarmaVigiC Database in the province. To determine the quality of each item in the collection model, the provisions of the Instructions for filling out the national database were used as a reference. Results: in 8.25 % of the reports the personal pathological history was omitted, 6.63 % did not define other drugs that the patient receives, 9 % did not correctly classify mild and moderate reactions, in 6% of the reports there were errors when classifying the imputability of the reactions, 9.1 % did not correctly identify the most affected organ system. The non-notification of the route, dose, batch and date of administration of other drugs occurred in approximately 7 % of all cases. Conclusions: the process of filling in the FarmaVigiC database presented difficulties due to the omission and non-adherence to the instructions created with a view to homogenizing the information.

Keywords

• farmacovigilancia
• sistemas de registro de reacción adversa a medicamentos
• notificación