Drug safety monitoring in the Republic of Sakha (Yakutia)

Abstract

The aim of the research is analysis of frequency and nature of adverse reactions during the use of drugs in the Republic of Sakha (Yakutia) according to automated information system of Russian Federal Service for Surveillance in Healthcare “Pharmacovigilance” (Roszdravnadzor “Pharmakonadzor”). Material and methods. Data from the AIS Roszdravnadzor “Pharmakonadzor” in the Republic of Sakha (Yakutia) for the period from 2014 to 2019 were used for the analysis. It should be noted that since April 1, 2019 data collection is carried out using the modified notification form. Results. For the period of 2014-2019 300 reports (292 primary and 8 repeated) on adverse reactions and cases of therapeutic ineffectiveness of drugs were registered. According to the leading criterion concerning person’s life severity, there were notifications on 20 deaths of patients, 60 life-threatening cases, 1 case of disability, 105 cases of hospitalization or prolongation of its terms, 35 clinically significant event cases. It was noted, that mainly, antimicrobial drugs and drugs for nervous system treatment caused adverse reactions. Conclusion. Report frequency on drugs adverse reactions or lack of therapeutic effect in the region was assessed as insufficient. There should be additional training for medical workers on the procedure for implementing pharmacovigilance in medical organizations, correct notification filling, which ensures reports completeness and its quality