The implementation of pharmacovigilance activities is impossible in isolation from compliance with the quality requirements of medicines and the activities of pharmaceutical and medical organizations throughout the pharmaceutical practice, as well as without access to sales plans, sales results and full relevance of information on drug conditions in all markets and in all cases of application. Properly conducted audit or inspection evaluation of the pharmacovigilance system makes it possible to identify and prevent drug safety problems at all stages of its life cycle.

The aim. Development of a risk-based strategy for planning and passing audits and inspections of the pharmacovigilance system for the subsequent creation of effective programs for assessing the pharmacovigilance system on its basis.

Material and methods. The study used structurallogical, empirical methods, general logical methods of scientific knowledge, methods of generalization and extrapolation.

Results. The plans and results of audits and inspections of pharmacovigilance systems of Russian and foreign pharmaceutical organizations and their pharmacovigilance vendors were analyzed. A risk-based strategy and a checklist for planning internal and external audits of pharmacovigilance systems of Russian pharmaceutical organizations and their vendors for pharmacovigilance have been developed and recommendations for training internal auditors of pharmacovigilance systems and audit teams have been developed for them.

Conclusion. Risk assessment indicators adapted for Russia have been developed, according to which Russian pharmaceutical organizations and their pharmacovigilance vendors can assess the likelihood of the risk of priority inclusion in the plan of Russian inspections of pharmacovigilance systems for compliance with the requirements of the good pharmacovigilance practice of the Eurasian Economic Union. Recommendations were prepared for the executive management and pharmacovigilance specialists of Russian pharmaceutical organizations in terms of assessing regulatory risks for the quality system of the pharmacovigilance system, planning and conducting audits; evaluating the relationship of pharmacovigilance with other good practices and with information from the plans and results of the organization as a whole. The indicators adapted for Russia for assessing the compliance of the pharmacovigilance system with the rules of the NPF EAEU are given.

Multiple myeloma (MM) accounts for 1 % of all cancers and about 10 % of all hemoblastoses. The use of innovative technologies with the inclusion of targeted drugs leads to a significant improvement in the quality of pharmacotherapy and the achievement of overall survival (OS).

The aim of the work is to conduct a pharmacoeconomic analysis of the most used MM therapy regimens with the use of targeted drugs and to determine the dominant treatment regimens using a costeffectiveness analysis.

Materials and methods. To determine the cost of a course of treatment, we summed up the costs of drugs included in the pharmacotherapy regimen, taking into account taxes, marginal trade markup and duration of the course. 

Dosing of the targeted drug included in the regimen was determined according to the official instructions for the drug. Progression-free survival (PFS) was adopted as the main criterion for the effectiveness of treatment. Information on PFS of targeted drugs was obtained from data from international phase III RCTs — ASPIRE, TOURMALINEMM1, POLLUX and ELOQUENT2.

Results. Based on the results of the pharmacoeconomic analysis, the dominant treatment regimen for MM was determined — daratumumab / lenalidomide / dexamethasone, which has the best cost-effectiveness ratio. The combination of elotuzumab / lenalidomide / dexamethasone was recognized as the least effective technology.

Introduction. Incidence of inadequate medication adherence to secondary prevention medications among Russian coronary patients is around 50 %, but the question, how this might influence on the risk of unfavorable outcomes, still has no answer.

Aim. To determine the effect of medication adherence on the risk of unfavorable clinical outcomes in outpatients with stable coronary artery disease (CAD).

Methods. Prospective observational cohort study was conducted. 281 subjects with verified stable CAD were included in line with the pre-specified criteria. Medication adherence was measured by validated 8-item Morisky scale. Data on cardiovascular events were obtained over the 24-month monitoring period. Study endpoint was a composite cardiovascular event (all-cause mortality, acute myocardial infarction, unstable angina, revascularization surgery, acute heart failure, decompensation of chronic heart failure). Survival analysis by Kaplan — Meier method was performed.

Results. 26.0 % of coronary outpatients had low medication adherence (below 6 points by Morisky scale). Groups of patients with satisfactory and low medication adherence were comparable by demography, medical history, and pharmacotherapy. Over the monitoring period composite cardiovascular event was registered in 115 patients (40.9 %). 46.6 % of patients from the low adherence group suffered from the composite event, 38.9 % — from the satisfactory adherence group. Time to the event was lower in the low adherence group — median 24.2 (IQR 7.5-29.2) vs. median 27.9 (IQR 17.4-34.5) months. Cumulative incidence of the composite cardiovascular event over the monitoring period was higher in the low adherence group compared to satisfactory adherence group (p=0.032; log-rank test), also when adjusted for history of cardiovascular events (p=0.033; log-rank test). Satisfactory medication adherence reduced risk of composite cardiovascular event by 37 % (HR 0.63; 95 % CI 0.42-0.94; р=0.025; Cox-regression adjusted for history of cardiovascular events).

Conclusion. Coronary outpatients with satisfactory medication adherence had lower risk of cardiovascular events over the 24-month monitoring period. 

Aims. To consider factors associated with adverse outcome among hospitalized patients with moderate and severe COVID-19.

Materials and methods. Data from 345 case histories of adult patients hospitalized with moderate to severe COVID-19 were analyzed in a single-center retrospective study. Characteristics by sex, age, number of days from disease onset to admission to hospital, duration of hospitalization, duration of disease, population characteristics by medical history of comorbidities and self-medication, outcome of hospitalization and medical technologies used in hospital conditions were given for the whole cohort of patients. All parameters were analyzed using descriptive statistics methods. Qualitative variables are given in absolute (n) and relative (%) values with 95% confidence interval. Continuous variables were presented as median and quartiles. Risk factors for mortality were determined across groups using the χ2  criterion and odds ratio.

Results. There was no demonstrated effect of gender, degree of pulmonary tissue lesions on computed tomography data, or time of initiation of respiratory support on disease outcome. At the same time, the age older than 65 years as well as neoplasms, type 2 diabetes mellitus, dementia, Stage 3 arterial hypertension, chronic heart failure, coronary heart disease, myocardial infarction and stroke history, chronic obstructive pulmonary disease, bronchiectatic disease, urogenital diseases were the predictors of unfavorable outcome in patients with moderate and severe COVID-19 form. Prehospital use of antiplatelet agents, direct and indirect oral anticoagulants, drugs affecting the renin-angiotensin system, systemic glucocorticosteroids, antibiotics, antiviral drugs, and analgesics was associated with a decrease in the mortality rate in patients with moderate-to-severe COVID-19, as well as timely use of pronposition and transfer to intensive care unit.

Conclusions. Our findings are partially consistent with previous reports on the effect of risk factors on COVID-19 outcomes.

Relevance. Informing patients about the carriage of a pathogenic mutation may result in a psychologically traumatizing situation, characterized by acute stress reactions, post-traumatic stress disorder symptoms, or anxiety-depressive disorder. This highlights the importance of psychological counseling.

Objective. To investigate the effectiveness of psychological support in a patient with mutations in genes associated with hereditary breast cancer.

Materials and methods. Description of patient's medical history and results of instrumental psychological diagnosis after identifying a pathogenic mutation in the CHEK2 gene, which increases a risk of developing breast cancer to 20–40 % via genetic testing.

Results. The nature of emotional response in this case is determined by personal history — identification of ideas about one's possible disease with mother's one. The conducted psychological consultations mitigated acute stress reactions and minimized the perception of received genetic information as a psychologically traumatic event. Furthermore, significant positive shifts were observed in the formation of adaptive stresscoping strategies, awareness of one's own mental resources, and reinforcement of adherence to the dynamic observation plan.

Conclusion: Patients in situations involving the identification of mutations in genes associated with hereditary breast cancer require a personalized approach. Development of criteria for psychological support should be aimed at improving patients' quality of life not only in the immediate aftermath of information disclosure but also in the long term.

The features of ensuring the biosafety of the population and important production and economic facilities in Russia due to the growth of external military threats with the secret use of new types of biological weapons are described. Several new tasks of Russian medicine and pharmaceuticals, as well as regulation of the corresponding market of goods and services, have been formulated. It is important to create a protective integral military-biological potential for populating Russia for a group of dangerous infectious diseases based on many new achievements of science and technology. The definition of the term «genocide» as an object of international law at the level of the UN and Russian law is given. These are actions committed with the intent to destroy, in whole or in part, any national, ethnic, racial, or religious group in Russia. The diagnosis of the detection of deadly infectious and gene biologics can be problematic. The article provides recommendations for the mobilization strengthening of the health system and biosafety in general.