ANALYSIS OF REPORTS ON ADVERSE REACTIONS AND POOR EFFICACY OF MEDICINES IN LVIV REGION FOR THE PERIOD OF 2018-2020

Abstract

Aim. The paper aims at conducting the analysis of the reported adverse reactions and poor efficacy of medicines registered by the doctors of Lviv city and region in 2018-2020. Materials and Methods. The object of our study were the reports received by the State Expert Center of the Ministry of Health of Ukraine from doctors of Lviv district and region during 2018-2020 through the automated information system of pharmacovigilance and notification cards (form 137/o) about adverse reactions or the lack of efficacy of medicines. Methods of systemic, clinical, pharmacological and statistical approach are applied. Results and Discussion. In 2020, 323 cards of reports of adverse reactions or lack of efficacy of medicines were registered and submitted to the State Expert Center of the Ministry of Health of Ukraine. The analysis showed that adverse reactions to medicines were commonly found in women (59 %) than men (41%). The greatest number of detected adverse reactions was observed in patients aged 44 to 60 years - 28,2% and 60 to 75 years - 23,5%. Among drugs with proven causative factors, the first place in frequency of occurrence of adverse reactions was chemotherapeutic agents (40,3%), among which the leading positions, as in previous 2018 and 2019 years, took antibacterial agents (32,2%). Among the latter, in 12.7% of cases, adverse reactions were caused by antituberculosis drugs. The leading groups of drugs that caused adverse reactions in patients of the Lviv region during 2018-2020 were unchanged. Thus, the second place in the frequency of adverse reactions was taken by drugs that affect the cardiovascular system. Analyzing the dynamics of adverse reactions on the background of this group of drugs in 2018-2020, it should be noted an increase in the frequency of adverse reactions from 12.4% in 2018 to 19.2% in 2020. The third position in terms of the frequency of adverse reactions in 2018-2020 is invariably occupied by nonsteroidal anti-inflammatory drugs. Among the adverse reactions that occurred in patients in 2020, immediate type allergic reactions dominated (22.9%), but compared to 2018 - 43%, their number was significantly lower (p£0.05). Adverse reactions from the gastrointestinal tract in 2018-2020 occurred with almost the same frequency- 19.2; 16.5 and 18%, respectively, took second place. The third position in terms of frequency of occurrence, as in previous 2018-2020, was occupied by adverse reactions from the central nervous system. Therefore, when prescribing any drug, every doctor should always be prepared for an adverse reaction and the ability to provide qualified medical care. Conclusions. In terms of the frequency of adverse reactions, the leading drugs included chemotherapeutic agents (40.3%), agents that affect the cardiovascular system (19.2%) and nonsteroidal anti-inflammatory drugs (9.9%). Among adverse reactions to drugs, allergic reactions of the immediate type (22,9%), gastrointestinal reactions (18%) and as well as reactions from the central nervous system (10.2%). When prescribing any drug, every doctor should always be prepared for an adverse reaction and the ability to provide qualified medical care.

Keywords

• pharmacovigilance system
• pharmacotherapy
• adverse reactions of drugs