The article presents the results of evaluation of risk of development of undesirable reactions in case of application of cardiovascular medications out of listing of vitally needed and most important pharmaceuticals and Standard of medical care under stable angina pectoris from 01.01.2014 to 01.06.2017 out of 21 639 registered in the Federal database information sources. The data analysis was implemented using techniques of evaluation of degree of reliability of cause-and-effect relationship and also evaluation of ratio benefit and risk. The evaluation of manifestations of side-effects was applied and rating of greatest number of arriving messages in Federal okrugs was established. The higher level of arrival of messages concerning cases of serious undesirable reactions with high degree of reliability of cause-and-effect relationship is marked. The wide-spread application of cardiovascular medications and availability of risk of development of undesirable reactions requires continuity of monitoring of their safety.

The state policy for the safety of medicinal products involves analysis of specialists' competence in identifying adverse drug reactions (ADRs) during the use of medicinal products. It is of particular importance for the group of essential medicines, including those used in cardiology.The aim of the study was to assess ADR-reporting skills of doctors managing cardiology patients, with anti-arrhythmics as a case study.Materials and methods: from October 2019 to June 2021, the authors surveyed a sample of 223 practitioners that treated cardiology patients in Moscow and the Moscow region (36 of the respondents took the survey in person, and 187 participated on-line). The questionnaire inquired about selection criteria for the medicinal products, their assessment in terms of efficacy and safety in real-life clinical practice, and the competence and active involvement of the doctors in reporting identified ADRs.Results: most of the survey participants were high-level professionals (60.99% had 10 and more years of experience). Most of the doctors (90.13%) admitted having encountered ADRs in their practice, placing substandard quality of cardiovascular medicinal products among the causes. Moreover, 1.79% of the respondents faced such quality problems on a regular basis. Only 52.91% were familiar with the current documents regulating pharmacovigilance. A total of 61.88% applied information from Russian and foreign ADR databases in their practice. In 2021, 80.72% of the surveyed did not report data on the identified ADRs. According to the respondents, the main reasons for low reporting activity were high workload and lack of evidence for causality between a product and an ADR.Conclusion: the study demonstrated the need to intensify the work with practitioners on the safety of medicinal products and ADR identification, particularly, to train them in pharmacovigilance. According to the study results, it is feasible to develop and implement simple and user-friendly risk-oriented information systems for analysis and systematisation of ADR case reports.

A high level of morbidity and mortality from cardiovascular diseases remains prevalent in the Russian Federation, despite a decreasing trend that emerged in recent years. Rhythm and conduction disorders play an essential role in the thanatogenesis of cardiovascular pathology, which determines the medical and social significance of their pharmacotherapy. This is indicated by the stable demand for antidysrhythmic drugs from both the state and the population. This is evidenced by high levels of public procurements and retail sales of drugs for the treatment of cardiovascular diseases, since patients take this drug group for a long time and often permanently. Our marketing analysis of the antidysrhythmic drugs market used current open data from the State Register of Medicines and the State Register of Maximum Selling Prices and available analytical data. It showed that from 54.5% (metoprolol drugs) to 100% (procainamide drugs) of the market share is occupied by generic drugs made in Russia. The presented analysis confirms the assumption of a significant increase in the share of generic drugs in public procurements. This is associated with the implementation of the drug safety program for vital and essential drugs and the optimization of costs by the state. A priority of the state drug policy in Russia is to monitor the effectiveness and safety throughout its entire life cycle. Moreover, particular importance should be given to the issue of interchangeability, which is regulated by Federal Law No. 1360 dated September 5, 2020, On the Procedure for Determining the Interchangeability of Medicines for Medical Use. The annual increase in the share of generic domestic antidysrhythmic drugs on the market poses the problem of selecting the most efficient and safe approach to pharmacotherapy for practicing specialists. The solution may be to develop and implement open automated information systems for the safety profiles of the original and generic antidysrhythmic drugs.