Pharmacovigilance: focus on the analysis of spontaneous reports of adverse drug reactions

Abstract

Objective: using the example of data for 2019–2020 in the Rostov region, to analyze the characteristics of spontaneous reports (SR) of adverse drug reactions (ADRs), as well as to assess their correlation with the individual characteristics of patients and the drugs used. Materials and methods: The object of a retrospective descriptive study was 234 SR about ADRs registered in the Rostov region in 2019-2020. Results: highest number of SR about ADRs in 2019–2020 were associated with drugs from the group "Nervous system, "Alimentary tract and inclusion metabolism" and "Antineoplastic and immunomodulators". In 2019, as well as in 2020, there was a statistically significant correlation between the indicators of the drug group and the type about ADRs, the age of the patient and the outcome of the developed ADRs. In addition, in females, a significant relationship was established between the criterion for the severity about ADRs and its outcome. Conclusions: the results obtained during the implementation of this study include the identification of common values and prerequisites for the development about ADRs in 2019 and 2020, and therefore can be taken into account when assessing a risk-based algorithm for the exclusion and emergency of identifying ADRs. This, in turn, inevitably constitutes and personalizes the choice of pharmacotherapy, balanced in terms of "efficacy-safety".