Implementación de un programa de farmacovigilancia activa en la unidad de nefrología del Hospital de Especialidades Carlos Andrade Marín en pacientes con trasplante renal

Abstract

The aim of this study was the implementation of an Active Pharmacovigilance Program (APP) in the Nephrology Unit of the Carlos Andrade Marín Specialty Hospital in patients with renal transplants. For this purpose, a retrospective and prospective non-experimental research was carried out, which was divided into two phases. The first one was based on the analysis of adverse event notification matrices (AEN) in the period 2016-2019, for the diagnosis of the current situation, through the method of observation and interviewing the health personnel, the opportunity of intervention was detected to carry out the second phase, which consisted of the development of the active pharmacovigilance program (AFP) for kidney transplant patients with pharmacotherapy including cyclosporine, everolimus, mycophenolate and tacrolimus during September 2019 to January 2020 where It was applied patient interviews, a hospital pharmacovigilance protocol, a yellow card for recording reported AFP for analysis in tables and graphs, besides it was used audiovisual and didactic material to socialize the importance of AFP to medical personnel and provided health education to patients to avoid possible AEN. The results obtained after a retrospective analysis showed that immunosuppressive drugs were the most reported with 90.95%, being cyclosporine with 47.73% the most reported. In the AFP application, it was obtained that 66.7% of the reports corresponded to adverse drug reactions, being tacrolimus the most reported with 44.44%. It was concluded that a program of AFP to transplanted patients and immunosuppressive drugs is relevant, because they are chronic patients and these drugs show a higher percentage of AEN reporting, besides, this method showed a higher number of reports compared to VFP. It is recommended to extend the time of this AFP program and to broaden the inclusion criteria.