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Kachestvennaya Klinicheskaya Praktika = Good Clinical Practice

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No 1 (2022)
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FROM EDITOR

PHARMACOECONOMICS

4-16 1261
Abstract

Basis-bolus insulin therapy is a cornerstone of Diabetes Mellitus type 1 (DM1T) control. Basal insulin analogs — glargine 300 U/ml (iGla 300), glargine 100 U/ml (iGla 100), detemir (iDet) degludec (iDeg), — as well as prandial insulins — glulisine (iGlu), aspart (iAsp) and lispro — are used widely during last 10–15 years. Aim. Evaluation of a comparative economic efficacy of the different basis-bolus schemes of insulin therapy in DM1T in adults. Materials and methods. Analysis has been performed for the following schemes: iGla 300 + iGlu, iGla 100 + iGlu, iDet+iAsp, iDeg+iAsp from Govt position based on modelling of the efficacy for 5 years. Data regarding probability of complications based on glycated hemoglobin (HbA1c) reduction for human insulin treatment and insulin analogs were taken into modelling. Direct medical costs were calculated for insulins, complications, hypoglycemic including severe events. Sensitivity analysis has been performed for validation of the received results. Results: Insulin analogs have economic advantages in compare with human insulins for DM1T control for 6.5 years. They could reduce expenditures in 1.89 times. iGla 300 + iGlu and iDeg+iGlu reduced HbA1c more effective among analogs and hypo events were more rare also (35.0 episodes/patient/year), including severe (0.57 and 0.70 episodes/patient/ year accordingly) vs iGla 100 + iGlu and iDet+iAsp (37.8 and 39.9 episodes/patient/year and 1.10 and 1.21 episodes/patient/ year for severe accordingly). Calculated direct medical costs were less for iGla 300 + iGlu, after that were following iGla 100 + iGlu, iDet+iAsp and last (highest) were expenditures for iDeg+iAsp. Conclusion. Created model prognoses complications of DM1T depending on schemes of insulin therapy and calculates of direct costs. iGla 300 + iGlu has economic advantages vs iGla100 + iGlu, iDet+iAsp and iDeg+iAsp in DM1T control during 5 years horizon.

17-29 964
Abstract

Target therapy of severe atopic dermatitidis (AD) is actual because AD has a high prevalence and social-economic burden. Target therapy consists of monoclonal antibodies (dupilumab) as well as janus kinase inhibitors (upadacitinib and baricitinib). Aim. Health technology assessment of the severe AD target therapy in adults. Мaterials and methods. EASI-75 has been chosen as efficacy criterion in the clinical trial of dupilumab 300 mg every 2 weeks and upadacitinib 30 mg od during 24 weeks, indirect treatment comparison for dupilumab and baricitinib 4 mg od with odds ratio (OR) during 16 weeks has been performed. Modelling with “Tree of decision” method was made for comparable efficacy evaluation on 52-d week of the treatment. Direct medical cost has been calculated for: target and topic therapy, complications, prophylaxis of janus kinase inhibitors side effects. Budget impact analysis for janus kinase inhibitors substitution with dupilumab during 3-years horizon on 100 pts was performed. Multilateral sensitivity analyses were made for results validation. Results. Efficacy of dupilumab and upadacitinib on point 24 w were equal (EASI-75 59,5 % [95 % CI: 54,4; 64,7] and 64,2 % [95 % CI: 59,1; 69,2] accordingly) and on 52 w (65,0 % and 69,0 %, OR vs dupilumab 1,1 [95 % CI: 0,68; 2,1]). Dupilumab has more efficacy than baricitinib on 16 w of therapy (EASI75 65,7 % and 48,0 % accordingly, OR 2,09 [95 % CI: 1,31; 3,35]) and on 52 w (65,0 % and 55,7%, OR vs dupilumab 0,75 [95% CI: 0,47; 0,96]). Dupilumab had economic advantages on 21 % vs upadacitinib during year (993 495 Rub. and 1 253 164 Rub. per patient accordingly based on cost-minimization analysis). Dupilumab was on 11,8 % more economic vs baricitinib based on cost-effective analysis during one year of therapy also. Substitution of janus kinase inhibitors on dupilumab can lead to budget saving on 18,1–44,9 % during 3 years. Results were confirmed by sensitivity analyses. Conclusion. Health Technology of the severe AD treatment in adults with dupilumab is an economic proved.

30-40 1178
Abstract

According to the International Continence Society (ICS), symptoms of overactive bladder (OAB) are present in 17 % of the adult population of Europe. The prevalence of overactive bladder in Russia is unknown but is considered comparable to that in European countries. According to Russian guidelines, patients with OAB could be treated with antimuscarinics or beta 3-agonists. The results of a meta-analysis by Wang J et al. (2018) showed comparable efficacy and safety of mirabegron and solifenacin. At the same time, according to Chapple CR et al. (2017) and Yeowell G et al. (2018) the use of mirabegron is associated with greater adherence to therapy and longer average drug use before the need to change therapy compared to antimuscarinics. From an economic point of view, greater adherence to drug therapy is associated with lower costs per patient with OAB per year and mirabegron have demonstrated to be cost-eff ective in comparison to solifenacin. The results of the analysis of the structure and volume of providing various types of medical care to patients with OAB in the Moscow region demonstrate the need to expand approaches to providing drug care to this group of patients. Currently, the majority of costs related to patients with OAB are associated with surgical treatment, which indicates the opportunity to expand the possibilities of drug therapy, including within the framework of preferential drug provision.

HEALTH TECHNOLOGY ASSESSMENT

41-52 1306
Abstract

Relevance. Ademetionine is a hepatoprotective drug, is included in the  draft Russian clinical guidelines for the  diagnosis and treatment of non-alcoholic fatty liver disease (NAFLD) and in the  clinical guidelines for treating intrahepatic cholestasis (ITH), the cost analysis of treating patients with ITH and NAFLD is topical. Aim. The cost analysis of treatment with ademetionine for ITH and NAFLD in the Russian Federation. Methods. This clinical and economic analysis was conducted in accordance with the requirements of GOST R 57525–2017 and the methodological recommendations of the  Center for Expertise and Quality Control of Medical Care. At the  first stage, to determine the  structure and number of costs, a review of legal acts and publications on the  pharmacoeconomic analysis of clinical situations and drugs of interest in the  e-Library and ConsultantPlus databases was carried out. The  source of prices for medical services was the tariffs of the compulsory medical insurance system and data from the tariff agreement in Moscow within the framework of the compulsory medical insurance system, and in the absence of tariffs, the  prices for paid medical services. Prices for drugs were obtained from an open source — the  Russian Pharmaceutical Portal (Pharmindex.rf). In the  absence of data on the  cost structure, a survey of physicians conducted through a questionnaire. Results. Because of the literature review, 34 publications were found in the  e-Library database on the use of ademetionine in NAFLD and ITH. Additionally, outside the scope of the literature review, a study was found in 2011, which provides a comparative clinical and economic analysis of the  use of ademetionine (Heptral®) and essential phospholipids (Essentiale) in alcoholic liver damage and in infectious hepatitis. A review of legal acts in the  ConsultantPlus database initially identified 93 documents, of which 25 turned out to be irrelevant to the current purpose of the study, that is, they didn’t allow analyzing the costs of ademetionine therapy. Of the 20 identified standards of medical care, only 2 are devoted to diseases of the liver and biliary tract. Because of the analysis, it was revealed that the cost per case of NAFLD treatment in a round-the-clock hospital amounted to 24.6 thousand rubles; in a day hospital, the  cost per case of both NAFLD and ITH in adults amounted to 19.8 thousand rubles each. The average total cost of treating one patient during the year on an outpatient basis for NAFLD amounted to 65.3 thousand rubles, of which only 14.3 thousand rubles. covered by the compulsory medical insurance system, 16.9 thousand rubles outside the compulsory medical insurance system and 34.1 thousand rubles — drug costs. The average total costs for treating one patient during the year on an outpatient basis from ITH amounted to 65.4 thousand rubles, of which 23.9 thousand rubles. covered by the compulsory medical insurance system, 17.6 thousand rubles outside the compulsory medical insurance system and 23.9 thousand rubles — drug costs. Conclusion. Because of the study, the average costs for treating patients with NAFLD and ITH were calculated, which can later be used to conduct other types of pharmacoeconomic analysis.

DRUG SAFETY

53-63 2494
Abstract

Pulmonary arterial hypertension is a condition characterized by an increase in mean pressure in the pulmonary artery. This pathology is associated with high mortality, and specific therapy for pulmonary arterial hypertension does not affect the cause of the disease and is extremely expensive. In this regard, it is especially important to study the modifiable etiological factors of pulmonary arterial hypertension. One such factor is drugs. One of the leading groups of drugs-inductors is anorexigenic drugs. It was the representatives of this group, such as aminorex, who were the first inducers of pulmonary hypertension. Moreover, this adverse reaction was so significant that it led to the withdrawal of these drugs. Currently, the leading role in the context of drug-induced pulmonary hypertension is played by such drugs as anticancer, antiviral drugs, and interferons. These drugs lead to pulmonary hypertension through various pathophysiological mechanisms. The leading measures to prevent this pathology are to limit the use of culprit medications, reduce the spread of HIV infection, since several groups of drugs can be used to treat HIV-infected patients, leading to the development of pulmonary hypertension.

QUALITY OF LIFE

64-71 974
Abstract

Introduction. The COVID-19 pandemic has made adjustments in lifestyle of young people. Distance learning at university, staying at home for a long time, limiting social contacts lead to decrease in physical activity, changes in eating behavior and psychological problems. All this is only a small part of the  negative impact of the  current epidemiological situation on the health of young people. Aim and Methods. To estimate the impact of the COVID-19 pandemic on the lifestyles of young people, a comparative analysis was made of various aspects of the lifestyles of 208 medical students before the pandemic in 2019 and 100 medical students during the COVID-19 pandemic in 2021. To collect information, a specially developed questionnaire was used, which included questions about diet, physical activity, bad habits, psychological status, and also measured anthropometric indicators (height, body weight, waist circumference) and blood pressure. Results. Both negative changes in character and regime of taking meal, decrease in physical activity and increase in psychological problems such as stress and depression were revealed among medical students during the  COVID-19 pandemic, which can facilitate increasing the  body weight of young people, as well as increasing the prevalence of bad habits (alcohol consumption, smoking). Conclusions. The existing epidemiological situation with the new coronavirus infection that has developed throughout the world made a negative impact on the lifestyle of young people. Currently, despite the  active fight against COVID-19, it is advisable not to forget about timely monitoring and modification the lifestyle of the young people, which in turn is the key to successful prevention of the most common noninfectious diseases with leading position of mortality throughout the world.

PROVISION OF DRUGS

72-84 1335
Abstract

Relevance. Currently, the  implementation of information systems in healthcare is an urgent task for every medical organization. The main directions of the introduction of a medical information system in a medical organization are the development of automatic workplaces for specialists, the development of specialized soft ware for decision-making; creation of an electronic medical record and automation of managerial and administrative functions. With the  right management approach to the operation of a medical information system (MIS), a medical organization can use all the possibilities of a MIS to reduce the labor costs of its employees in various areas, for example, in the case of the circulation of drugs. Objective. Show the possibilities of using MIS on the circulation of drugs in a multidisciplinary hospital. Methods. The work was carried out on the basis of the MIS of the North-Western State Medical University named after I. I. Mechnikov of the Ministry of Health of Russia through the introduction of a drug circulation system in a medical organization at various levels (clinical units, a pharmacy, the administration of a medical organization). Results. In the article, on the example of a multidisciplinary medical organization, the results of the implementation of accounting, planning and control over drug supply in the MIS are presented. Conclusion. The joint work of all departments involved in the circulation of drugs (pharmacy warehouse, purchasing department, clinical departments and clinical pharmacologist) allows improving the quality of drug supply and timely obtaining information about the costs and needs for medicines, which optimizes the financial costs of drugs in the hospital.



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ISSN 2588-0519 (Print)
ISSN 2618-8473 (Online)