Active monitoring of medicine safety by the national regulatory authority. Cuba, 2020 -2023

Abstract

Introduction: CECMED has a network of focal points for active surveillance since 2014, its purpose is to strengthen the Pharmacovigilance activity of the Cuban System.

Objective: Describe the results of the active surveillance of medications carried out by the Network of Pharmacovigilance Focal Points of the National Regulatory Authority in Cuba in the period 2020 - 2023.

Methods: An observational and descriptive study was carried out, using the strategy of sentinel surveillance through the focal points of the regulatory authority. The studies were multicenter, cross-sectional or longitudinal depending on the objective set in each design. We worked with the universe of patients who received treatment with the medications subject to surveillance. The reports made were incorporated into the national pharmacovigilance database.

Results: Fifty-five active surveillances were carried out, where 2,124 reports of adverse reactions were recorded (11.6% of the total reports). The drugs with the highest reports were Heberón (25.4%), Heberferón (24.1%),  prevengho-vir (9.5%), Nasalferón (3.4%) and Biomodulin T (0.9%). The main adverse reactions reported were fever, headache, high blood pressure and diarrhea. Mild-moderate (99.7%) and probable (37.6%) reactions predominated. Reports of low frequency of occurrence represented 15.6%.

Conclusions: The Network of Pharmacovigilance Focal Points for Cuba functions as a network of proactive surveillance sites to know the safety profile of medications when the general population or special groups thereof use them.