ABSTRACT
SUMMARY Introduction: Pharmacovigilance and patient safety programs have in common the monitoring of drugs, but despite sharing epidemiological method, language and legislation, there does not seem to be a clear relationship between them. Objectives: Characterize and analyze the reports sent to the institutional patient safety program. Materials and methods: Observational descriptive cross-sectional study of the reports database from an institutional patient safety program during 2016. Medication errors were classified according to the document WHO 2009. Adverse Drugs Reactions (ADR) were classified according to Uppsala Monitoring Center. Results: From the patient safety program it was detected that the omission of drugs or doses was the most frequent error (42.8%) followed by ADRs (20.9%). Harmful incidents were the most frequent (61.2%) followed by no harm incidents (38.8%). From the pharmacovigilance program 41 ADR and 15 therapeutic failures were identified, in which Phlebitis was the most frequently reported (23, 7%) followed by hypersensitivity reactions (18.4%) and excessive neuromuscular blockade (13.1%). Conclusions: A very important amount of incidents is not considered by any of the two programs, losing a valuable risk management opportunity. The program did not identify a clear distinction between harmful incident and ADR.
RESUMEN Introducción: Los programas de farmacovigilancia y seguridad de pacientes tienen en común la vigilancia de los medicamentos, pero a pesar de compartir método epidemiológico, lenguaje y legislación, no parece existir una clara articulación entre ellos. Objetivos: Caracterizar y analizar los reportes enviados al programa institucional de seguridad de pacientes. Materiales y métodos: Estudio observacional descriptivo de corte transversal de la base de datos de reportes de un programa de seguridad de pacientes durante el 2016. Los errores de medicación se clasificaron según el documento OMS del 2009. Las reacciones adversas (RAM) se clasificaron de acuerdo con el Uppsala Monitoring Center. Resultados: Desde el programa de seguridad de paciente se detectó que la omisión de medicamentos o dosis fue el error más frecuente (42,8%) seguido por las RAM (20,9%). Los incidentes con daños fueron los más frecuentes (61,2%) seguidos por los incidentes sin daño (38,8%). Desde el programa de farmacovigilancia se identificaron 41 RAM y 15 fallos terapéuticos siendo la flebitis las más frecuentemente reportadas (23,7%) seguidas de las reacciones de hipersensibilidad (18,4%) y el bloqueo neuromuscular excesivo (13,1%). Conclusiones: Una proporción importante de incidentes no es tenida en cuenta por ninguno de los dos programas, perdiéndose una valiosa oportunidad de gestión del riesgo. En el programa no se identificó una clara distinción entre incidente con daño y RAM.
ABSTRACT
Introduction: The Colombian national pharmaceutical policy establishes as a strategy the generation of greater pharmaco-epidemiological research at the national level, especially in the case of antibiotic drugs. Objective: To provide local pharmaco-epidemiological evidence regarding the effectiveness, conditions of use and safety of generic meropenem and cefepime in a tertiary hospital in Bogotá. Materials and methods: We conducted a descriptive, longitudinal and retrospective drug utilization study. The data were collected from the medical histories of all the patients who had cefepime or meropenem prescribed. Results: We included 82 patients treated with cefepime and 91 treated with meropenem in the study. Most of the patients were in services different from the intensive care unit (taking cefepime: 59.8%, and meropenem: 52.7%). Only 21.9% of the patients treated with cefepime and 49% of those treated with meropenem were seen by an infectious disease specialist. The antibiogram was performed for 47% and 60% of the patients treated with cefepime and meropenem, respectively. The most frequent indication for cefepime were respiratory infections and for meropenem, genitourinary ones. Therapeutic success rates were 61.7% for cefepime and 63.0% for meropenem. Conclusions: This study contributes evidence regarding the therapeutic performance of two generic antibiotics used in tertiary hospitals. There were no reports of therapeutic failure during the study period. In the cases of non-response, pharmacokinetic alterations, unfavorable clinical conditions, and inappropriate choice of antimicrobial treatment were identified as frequent factors.
