Relevance. WHO assesses headaches as a global world problem. Russia occupies a leading position in the prevalence of primary headaches. Headaches are one of the most common reasons for visiting a pharmacy for self-medication. The interaction of the pharmacist and the visitor with the headache problem in general determines the quality of pharmaceutical care.

Aim. To assess the practice of the interaction between a patient with a headache and a pharmacist using the simulated patient method.

Materials and methods. Trained simulated patients (women aged 20, 40 and 58 years) visited a total of 101 pharmacies. The dialogue was recorded on a voice recorder, all the features of the interaction were additionally recorded aſter the visit. Special forms were filled out based on the information received. The data was processed using Microsoſt Excel 2010 and STATISTIKA 10.0.

Results. The average interaction time was 98.2±3.8 seconds. There was a high frequency of spontaneous recommendations without preliminary questions (66.3%), a small number of questions asked (0.84±0.1). These indicators practically did not depend on various factors (type of pharmacy organization, age of the pharmacist, age of the simulated patient, the presence of a queue, and others).

Conclusion. The results of the study demonstrate a low level of interaction between pharmacists and visitors with a headache, as well as a practical absence of involvement in the process of providing pharmaceutical care, which negatively affects its quality: frequent spontaneous recommendations, short consultations and rare questions. The approach to the interaction of pharmacists with visitors with headaches is formal and requires standardization.

Relevance. Headaches are one of the most important health problems both in Russia and around the world, as well as one of the most common reasons for self-treatment in a pharmacy due to the availability of over-the-counter drugs. Pharmaceutical workers play an important role in the control of self-medication, and the rationality of drug recommendations determines the quality of pharmaceutical care.

Aim. To assess the rationality of drug recommendations for a patient with a headache and pharmaceutical drug counseling using the simulated patient method.

Materials and methods. Trained simulated patients (women aged 20, 40 and 58 years) visited a total of 101 pharmacies. The dialogue was recorded on a voice recorder, all the features of the interaction were additionally recorded aſter the visit. Special forms were filled out based on the information received. The data was processed using Microsoſt Excel 2010 and STATISTIKA 10.0.

Results. There was a high frequency of spontaneous recommendations without preliminary questions (66.3%), recommendations (14.9%) and dispensing of prescription drugs (5.0%), frequent recommendations of combined drugs (91.0%). Trade name Pentalgin (46.5%) and trade name Nurofen (42.6%), INN Ibuprofen (47.5%) were the most recommended. Combination analgesics were purchased in most of the visits (72.0%), information on the duration of use of the drug and the need to visit a doctor was never provided.

Conclusion. Pharmacists' recommendations are in most cases irrational, focused on the drug as a product and sometimes unsafe, and counseling is practically non-existent. Improving the quality of pharmaceutical care at this stage should include the development of standards for drug recommendations and adequate counseling.

Introduction. The results from foreign and local studies demonstrate that more than a half of patients with cardiovascular diseases do not take medication in compliance with doctors’ recommendations. The search for significant barriers to optimal medication adherence might improve the development of adherence control measures in patients with stable coronary artery disease (SCAD) in routine clinical practice of primary care.

Aim. To study the nature and incidence of potential barriers to optimal medication adherence and their association with social and demographic parameters in patients with SCAD.

Methods. This publication describes the fragment of the study “PHARMCARE” in which 123 coronary patients were included. Data on demography, social status, medical history and pharmacotherapy were registered. The barriers to medication adherence were identified by means of validated scale (questionnaire) SEAMS (Self-Efficacy for Appropriate Medication Use Scale). Data analysis was conducted by descriptive statistics and regression modeling.

Results. The analysis of incidence of barriers to medication adherence allowed to identify the list of most significant ones: “fear of side effects”, “intake of several different medicines each day”, “intake of medicines more than once a day”, “medicines look different than usual”, “normal routine gets messed up”, “busy day planned”, “no one reminds to take medicines” and “staying away from home”. More than a third of all the respondents reported at least one of barriers (37%), that was in major cases “fear of side effects” (22%). Linear one-factor modeling revealed association of number of significant barriers in patients with level of their education (р=0,009) and presence of partner or caregiver (р=0,001), that was also confirmed by the multivariate model. Less barriers were identified in coronary patients that had partner or caregiver (р=0,009) and higher education (р=0,045).

Conclusion. The study results revealed that the significant barriers to optimal medication adherence in out-patients with SCAD were related either to patients’ behavior or to pharmacotherapy profile. Uncertainty in overcoming barriers was most typical for single patients without higher education. The obtained results should be taken into consideration when develop strategies for improvement of medication adherence in patients with SCAD in primary care practice.

Background. No clinical trial could be initiated and conducted without appropriate clinical trial protocol. Any change in information relating to patients’ safety and health during the trial must be recorded and approved by a form of amendment to the clinical trial protocol, which is a time-consuming and financially expensive process for the Sponsors of these studies.

Goal. To analyze the probability of releasing of clinical trials protocols amendments and to determine the most "pregnable" period for their occurrence in the course of the trials.

Materials and Methods. The results of clinical trial protocols analysis are presented, which were approved by Russian Health Authorities between three years from 2017 to 2019 inclusive. In total, 20 protocols and 39 amendments were analyzed. Results. In the first year of the study, 21 amendments were issued, representing slightly more than half (54%) of the total number of amendments. During the second year, 12 amendments were issued, (31%). For the third year of the trial, only 3 amendments (7%) were made and for the fourth — 4, which is 8% of the total.

Conclusion. The largest number of protocol amendments came out at first two years of clinical trial. Thus, they are the most "dangerous" years in the life of a clinical study in connection with the examination of developed protocol in real life. These first two years show how carefully the protocol was designed, how it meets the requirements of regulatory authorities, criteria and recommendations of professional associations, how feasible and effective the various criteria and procedures are.

Relevance.  Cardio-vascular diseases (CVD) are the one of the main reasons of mortality and disability. Hypercholesterinemia is a factor of CVD progression, and thus it should be corrected. Combination of statin + ezetemib is an effective option of a medical technology for this purpose. Pharmacoeconomic analysis of rosuvastatin and ezetemib fixed combination (FC) has been performed in this work in comparison with free combination (FrC) of these drugs.

Materials and methods. Modelling of FC vs FrC in groups of CVD risk has been performed on 1–5 years horizon based on the local epidemiologic published data with aim of economic analysis. Efficacy of FC and FrC, direct medical costs, including cost of drugs, hospitalizations etc. were taken into account also. ICER has been calculated and compared with willingness to pay.

Results. FC usage instead FrC can prevent 2960–3055 deaths and 8880–9164 admissions to hospital caused CVD. FC decrease of ambulance cost as well as others direct medical expenditures in compare with FrC treatment on 9,3 bln RUR per 5 years. ICER has been calculated and has negative (dominant) result.

Conclusion. FC usage is an economic dominant technology in compare with FrC for hypercholesterolemia control.

Relevance. Diseases of the cardiovascular system remain one of the main causes of death worldwide. The incidence of cardiovascular and circulatory diseases increased by one third between 1990 and 2010. The prevalence of atrial fibrillation (AF) ranges from 2.5–3.5% in the general population of patients to 9–17% in individuals aged 80 years and older.

The aim of the study is to analyze the costs of the Russian healthcare system for various types of treatment of atrial fibrillation.

Materials and methods. The assessment of the present economic burden of AF included an assessment of such direct costs as inpatient treatment, outpatient visits, treatment in a day hospital, medical support, treatment of complications of AF.

Results. The socio-economic burden of AF in the Russian Federation for 2022 without surgical treatment amounted to 196.44 billion rubles per year, compared to 2010 and 2018, costs increased by 77% and 73%, respectively.

Cardiovascular diseases are the leading cause of death worldwide. It is possible to influence the development of these diseases by influencing their main pathogenetic link — dyslipidemia.

Aim: to evaluate, using the example of alirocumab, the potential effect of drugs affecting the activity of PCSK9 on the achievement of goals for the prevention of the development of cardiovascular diseases and cardiovascular complications in patients of working age who had an acute myocardial infarction (MI) less than a year ago, with uncontrolled dyslipidemia.

Materials and methods. The target group was created based on the Russian clinical guidelines; its number was calculated using Russian registry data. Based on the published results of the clinical trial of alirocumab ODYSSEY OUTCOMES in a group of patients with LDL cholesterol levels of more than 2.6 mmol/l (100 mg/dl), a model was built to estimate the number of fatal and non-fatal outcomes in the target group with standard therapy and with alirocumab.

Results. The effect of alirocumab administration was modeled in patients of working age who had a myocardial infarction less than 12 months ago with an LDL cholesterol level of more than 5.0 mmol/l, the number of this group in the Russian Federation was estimated to be 3,029 people. It has been shown that with therapy in this group, mortality can be reduced by 29%, and the number of non-fatal cardiovascular events — by 22%, i. e. alirocumab therapy in this group for 2 years can prevent 29 deaths and 185 non-fatal events, with an increase in the duration of therapy to 5 years, the number of lives saved will be 117 and 401 non-fatal cardiovascular events will be prevented.

Conclusion. Modeling has shown that alirocumab therapy in patients with recent myocardial infarction and LDL cholesterol levels above 5.0 mmol/L will significantly reduce mortality in this group and prevent the development of serious nonfatal cardiovascular complications, which will also reduce the burden on specialized hospitals, as well as prevent patients from becoming disabled. At the same time, decision making requires a balanced consideration of all ethical, clinical and economic aspects, including the assessment of costs and potential effects from the position of the of a willingness to pay and the formation of the budget of the health system.

Objective. Comparative pharmacoeconomic evaluation of upadacitinib, baricitinib and dupilumab for the treatment of moderate to severe atopic dermatitis.

Materials and methods. Study design — retrospective. Pharmacoeconomic analysis method — cost-effectiveness analysis, budget impact analysis. Data sources. On the effectiveness of compared alternatives — meta-analysis of randomized clinical trials for the compared drugs, clinical recommendations; on the cost of drugs — the state register of maximum selling prices.

Results. Lowest cost-effectiveness (CER) values for both EASI-75 and EASI-90 responses were for upadacitinib. For upadacitinib 15 mg/day, the cost of achieving EASI-75 and EASI-90 responses was reduced by 63.9 and 70.3%, respectively compared to dupilumab and by 44.2 and 46.8% compared to baricitinib. For upadacitinib 30 mg/day, the reduction in the cost of achieving the effect compared to dupilumab will be, respectively, 40.8 and 56.2%, and compared with baricitinib — 8,5 and 21.4%. The budget impact analysis (BIA) showed that the increase in the share of upadacitinib from 15 to 35%, and the proportion of baricitinib — from 5 to 10% due to a decrease in the proportion of patients, receiving dupilumab will reduce the budget impact in the treatment of patients with severe atopic dermatitis on the scale of the Russian Federation by a total of 11.6% (RUB 1.25 billion) with a single-step change from the first year and by 7.9% (RUB 0.86 billion) with a gradual change over 3 years. An analysis of missed opportunities showed that if the share of upadacitinib changes to 35% 741 patients can be additionally provided with therapy in the first year, 629 patients in the second year and 567 patients in the third (with a target population size of 4929 patients).

Conclusion. Increasing the share of upadacitinib will not only significantly reduce the burden on the budget of the healthcare system by refusing to use more expensive dupilumab in some patients, but also increase the proportion of patients achieving the goals of therapy in terms of EASI-75 and EASI-90.

Currently, there is no neuroprotective therapy for the treatment of Parkinson's disease (PD), which would slow down the progression of the pathological process and prevent the development of the neurodegenerative process. The applied symptomatic therapy does not give a positive effect. In this paper, an overview of antiparkinsonian medications that are used in the treatment of PD is made. These drugs give side effects, causing neurotoxicity, while chemical agents, i.e. oxygen radicals have an adverse effect on the structure or function of the central or peripheral nervous system.