Pub Date : 2019-07-17DOI: 10.17749/2070-4909.2019.12.2.125-144
D. Blinov, E. Akarachkova, A. Orlova, E. Kryukov, D. Korabelnikov
Aim - based on the existing regulations and recent documents from the regulatory bodies, determine the methodology for the development of clinical guidelines (CG) that meet the requirements of the legislation in the Russian Federation. Materials and methods . We analyzed a number of regulatory and subordinate acts confirming the concept and status of the CG, in particular, the Federal Law № 323- ФЗ “On the principles of health care for citizens of the Russian Federation”, Federal Law № 489- ФЗ “On the amendments to article 40 of the Federal Law “On compulsory medical insurance in the Russian Federation” and the Federal Law “On the principles of health care for citizens of the Russian Federation” concerning clinical guidelines, Order № 102 н of the Ministry of Health of the Russian Federation dated 28 Feb 2019 “Regulations on the scientific and practical council of the Ministry of Health of Russia” and Order № 103 н of the Ministry of Health of the Russian Federation of 28 Feb 2019 “On Approval of the procedure and terms for the development of clinical guidelines and their revision, the model format of clinical guidelines and requirements to their structure, contents and scientific validity of the information included in the clinical guidelines”. In addition, we used the documents of regulatory bodies of the Russian Federation, expert opinions from medical professionals and non-profit organizations as well as leading opinions from public sources. Results . Order № 102 н of the Ministry of Health of the Russian Federation secured the right of the scientific and practical council to consider and decide on the CG. Order № 103 н of the Ministry of Health of the Russian Federation approved the procedure and deadlines for the development/revision of the CG; the typical format of CG; the requirements for the structure of CG, its contents and scientific validity of the information included in the CG. A step-by-step algorithm was created for the procedure and timing of CG development and update; the above documents elaborate on the requirements to the structure of CG, the contents and scientific validity of the information included. There are also comments on the development and design of each CG section (title page, table of contents, list of abbreviations, terms and definitions, brief information on the disease, diagnosis, treatment, medical rehabilitation, prevention and follow-up care, organization of medical care, additional information, criteria for assessing the quality of medical care, list of references, composition of the working group on the development and revision of the CG, methodology of the development of the CG, reference materials, algorithms for doctor’s actions, patient information, assessment scales, questionnaires, and other patient assessment tools). The recently adopted requirements for CG registration are compared with the previous methodological recommendations of the regulatory bodies. Discussion. The unification of treatment str
{"title":"New framework for the development of clinical guidelines in Russia","authors":"D. Blinov, E. Akarachkova, A. Orlova, E. Kryukov, D. Korabelnikov","doi":"10.17749/2070-4909.2019.12.2.125-144","DOIUrl":"https://doi.org/10.17749/2070-4909.2019.12.2.125-144","url":null,"abstract":"Aim - based on the existing regulations and recent documents from the regulatory bodies, determine the methodology for the development of clinical guidelines (CG) that meet the requirements of the legislation in the Russian Federation. Materials and methods . We analyzed a number of regulatory and subordinate acts confirming the concept and status of the CG, in particular, the Federal Law № 323- ФЗ “On the principles of health care for citizens of the Russian Federation”, Federal Law № 489- ФЗ “On the amendments to article 40 of the Federal Law “On compulsory medical insurance in the Russian Federation” and the Federal Law “On the principles of health care for citizens of the Russian Federation” concerning clinical guidelines, Order № 102 н of the Ministry of Health of the Russian Federation dated 28 Feb 2019 “Regulations on the scientific and practical council of the Ministry of Health of Russia” and Order № 103 н of the Ministry of Health of the Russian Federation of 28 Feb 2019 “On Approval of the procedure and terms for the development of clinical guidelines and their revision, the model format of clinical guidelines and requirements to their structure, contents and scientific validity of the information included in the clinical guidelines”. In addition, we used the documents of regulatory bodies of the Russian Federation, expert opinions from medical professionals and non-profit organizations as well as leading opinions from public sources. Results . Order № 102 н of the Ministry of Health of the Russian Federation secured the right of the scientific and practical council to consider and decide on the CG. Order № 103 н of the Ministry of Health of the Russian Federation approved the procedure and deadlines for the development/revision of the CG; the typical format of CG; the requirements for the structure of CG, its contents and scientific validity of the information included in the CG. A step-by-step algorithm was created for the procedure and timing of CG development and update; the above documents elaborate on the requirements to the structure of CG, the contents and scientific validity of the information included. There are also comments on the development and design of each CG section (title page, table of contents, list of abbreviations, terms and definitions, brief information on the disease, diagnosis, treatment, medical rehabilitation, prevention and follow-up care, organization of medical care, additional information, criteria for assessing the quality of medical care, list of references, composition of the working group on the development and revision of the CG, methodology of the development of the CG, reference materials, algorithms for doctor’s actions, patient information, assessment scales, questionnaires, and other patient assessment tools). The recently adopted requirements for CG registration are compared with the previous methodological recommendations of the regulatory bodies. Discussion. The unification of treatment str","PeriodicalId":201824,"journal":{"name":"FARMAKOEKONOMIKA. Modern Pharmacoeconomic and Pharmacoepidemiology","volume":"18 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2019-07-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"117200098","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2019-07-17DOI: 10.17749/2070-4909.2019.12.2.86-90
G. Gildeeva, A. Belostotsky
The Eurasian Economic Union (EAEU) is an international organization for regional economic integration, established by the Treaty on the Eurasian Economic Union, which currently includes 5 countries - Russia, Kazakhstan, Belarus, Armenia and Kyrgyzstan. The EAEU ensures the freedom of goods movement, as well as services, capital and labor, conducting a coordinated, agreed/unified economic policy. The current practice of pharmacovigilance in the EAEU is of interest to potential foreign investors and market players. The aim of this study was to analyze the recent changes in pharmacovigilance in the EAEU countries in order to adopt the strategy of the pharmaceutical industry players. Materials and methods . The regulatory base of pharmacovigilance in the EAEU countries and the unified EAEU provisions on adverse reactions (ADR) were analyzed. A critical analysis of the current periodic safety update reports (PSUR) and risk management plans (RMP) was also carried out. Results. The united EAEU drug market is a complex system that incorporates 35 regulations, including the variety of good practice guidelines regarding the circulation of medicinal products (GMP, GCP, GLP, GDP, and GVP). This group of regulations contains basic documents on the inspection of production lines, the assessment of generic equivalence, the development of biological drugs, and the pharmacovigilance (PV). Currently, the ADR reporting in the EAEU countries is at a level lower than that in Russia. The common EAEU database of identified ADRs has been already initiated, but the number of incoming signals is quite small. The most common flaws of the PSUR are the late reports, the incorrect format and contents of those; the inconsistent information about the product, different from that of Roszdravnadzor, the discrepancy between the Patients information leaflet (“Instruction for medical use”) and the Summary of Product Characteristics (SmPC), and the lack of important and relevant scientific and clinical information. In the EAEU, the submission of Risk Management Plan (RMP) as part of the registration dossier is required for any new medication (New Chemical Entity), including a new combination of drugs. The present article also covers other updates in the Pharmacovigilance system, regulated by the Good Pharmacovigilance practice, which entered into effect on 01.01.2017, as well as the updated tasks for harmonization within the EAEU. Conclusions. The medicinal products circulating in the EAEU have to be checked for their efficacy and safety in order to identify possible negative consequences and/or individual patient intolerance. This information will serve to warn the medical staff and patients, veterinary specialists and animal owners about potential hazards of using these products. In the near future, the Eurasian Union plans to launch a “sanitation” campaign in the pharmaceutical market and get rid of low-effective and unsafe drugs. In this respect, the issues of pharmacovigilance b
{"title":"Recent changes in the pharmacovigilance system in the Russian Federation and the EAEU","authors":"G. Gildeeva, A. Belostotsky","doi":"10.17749/2070-4909.2019.12.2.86-90","DOIUrl":"https://doi.org/10.17749/2070-4909.2019.12.2.86-90","url":null,"abstract":"The Eurasian Economic Union (EAEU) is an international organization for regional economic integration, established by the Treaty on the Eurasian Economic Union, which currently includes 5 countries - Russia, Kazakhstan, Belarus, Armenia and Kyrgyzstan. The EAEU ensures the freedom of goods movement, as well as services, capital and labor, conducting a coordinated, agreed/unified economic policy. The current practice of pharmacovigilance in the EAEU is of interest to potential foreign investors and market players. The aim of this study was to analyze the recent changes in pharmacovigilance in the EAEU countries in order to adopt the strategy of the pharmaceutical industry players. Materials and methods . The regulatory base of pharmacovigilance in the EAEU countries and the unified EAEU provisions on adverse reactions (ADR) were analyzed. A critical analysis of the current periodic safety update reports (PSUR) and risk management plans (RMP) was also carried out. Results. The united EAEU drug market is a complex system that incorporates 35 regulations, including the variety of good practice guidelines regarding the circulation of medicinal products (GMP, GCP, GLP, GDP, and GVP). This group of regulations contains basic documents on the inspection of production lines, the assessment of generic equivalence, the development of biological drugs, and the pharmacovigilance (PV). Currently, the ADR reporting in the EAEU countries is at a level lower than that in Russia. The common EAEU database of identified ADRs has been already initiated, but the number of incoming signals is quite small. The most common flaws of the PSUR are the late reports, the incorrect format and contents of those; the inconsistent information about the product, different from that of Roszdravnadzor, the discrepancy between the Patients information leaflet (“Instruction for medical use”) and the Summary of Product Characteristics (SmPC), and the lack of important and relevant scientific and clinical information. In the EAEU, the submission of Risk Management Plan (RMP) as part of the registration dossier is required for any new medication (New Chemical Entity), including a new combination of drugs. The present article also covers other updates in the Pharmacovigilance system, regulated by the Good Pharmacovigilance practice, which entered into effect on 01.01.2017, as well as the updated tasks for harmonization within the EAEU. Conclusions. The medicinal products circulating in the EAEU have to be checked for their efficacy and safety in order to identify possible negative consequences and/or individual patient intolerance. This information will serve to warn the medical staff and patients, veterinary specialists and animal owners about potential hazards of using these products. In the near future, the Eurasian Union plans to launch a “sanitation” campaign in the pharmaceutical market and get rid of low-effective and unsafe drugs. In this respect, the issues of pharmacovigilance b","PeriodicalId":201824,"journal":{"name":"FARMAKOEKONOMIKA. Modern Pharmacoeconomic and Pharmacoepidemiology","volume":"11 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2019-07-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"128639848","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2019-07-17DOI: 10.17749/2070-4909.2019.12.2.91-114
I. Torshin, O. Gromova, Z. Kobalava
The subject of this article is the obvious crisis of evidence-based medicine in the 21st century. As a typical example of a contemporary “evidence-based study”, here we analyze in detail a text published in 2018 in the Cochrane Database Syst Rev journal under the code number “CD00317F. The authors claim that ω -3 polyunsaturated fatty acids (PUFAs) are not effective either for the prevention of cardiovascular mortality or for any other outcomes mentioned by the authors. A detailed analysis of this text, however, pointed to gross violations of data collection and processing. By using modern mathematical methods for big data analysis we were able to demonstrate clearly that the authors of the text CD003177 used clinically heterogeneous cohorts of patients. We then selected a subsample of 19 clinically homogeneous studies (total of 64771 patients) and conducted a meta-analysis of this data. According to the results, an increase in consumption of ω -3 PUFA -eicosapentaenoic (EPA) and docosahexaenoic (DHA) acids - by 1 g/day was associated with a significant decrease in the risk of mortality by an average of 5% (OR - 0.945, 95% CI - 0.907-1.008; P=0.054). This meta-analysis was based on the modified clinical, laboratory and anthropometric criteria in the selected studies. In addition, we used the most important characteristics of ω -3 PUFAs pharmaceutical forms and the modern statistical analysis of biomedical data. With the above modifications, we managed to select a homogeneous subsample of clinically relevant studies. We also applied methods of sentiment analysis to demonstrate a subjective approach used by the above authors regarding the role of PUFAs in the prevention of cardiovascular morbidity. Using the language of today social media, some adepts of evidence-based medicine implement propaganda techniques to literally “repress” ω -3 PUFAs.
{"title":"Concerning the “repression” of ω -3 polyunsaturated fatty acids by adepts of evidence-based medicine","authors":"I. Torshin, O. Gromova, Z. Kobalava","doi":"10.17749/2070-4909.2019.12.2.91-114","DOIUrl":"https://doi.org/10.17749/2070-4909.2019.12.2.91-114","url":null,"abstract":"The subject of this article is the obvious crisis of evidence-based medicine in the 21st century. As a typical example of a contemporary “evidence-based study”, here we analyze in detail a text published in 2018 in the Cochrane Database Syst Rev journal under the code number “CD00317F. The authors claim that ω -3 polyunsaturated fatty acids (PUFAs) are not effective either for the prevention of cardiovascular mortality or for any other outcomes mentioned by the authors. A detailed analysis of this text, however, pointed to gross violations of data collection and processing. By using modern mathematical methods for big data analysis we were able to demonstrate clearly that the authors of the text CD003177 used clinically heterogeneous cohorts of patients. We then selected a subsample of 19 clinically homogeneous studies (total of 64771 patients) and conducted a meta-analysis of this data. According to the results, an increase in consumption of ω -3 PUFA -eicosapentaenoic (EPA) and docosahexaenoic (DHA) acids - by 1 g/day was associated with a significant decrease in the risk of mortality by an average of 5% (OR - 0.945, 95% CI - 0.907-1.008; P=0.054). This meta-analysis was based on the modified clinical, laboratory and anthropometric criteria in the selected studies. In addition, we used the most important characteristics of ω -3 PUFAs pharmaceutical forms and the modern statistical analysis of biomedical data. With the above modifications, we managed to select a homogeneous subsample of clinically relevant studies. We also applied methods of sentiment analysis to demonstrate a subjective approach used by the above authors regarding the role of PUFAs in the prevention of cardiovascular morbidity. Using the language of today social media, some adepts of evidence-based medicine implement propaganda techniques to literally “repress” ω -3 PUFAs.","PeriodicalId":201824,"journal":{"name":"FARMAKOEKONOMIKA. Modern Pharmacoeconomic and Pharmacoepidemiology","volume":"55 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2019-07-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"114471653","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2019-07-17DOI: 10.17749/2070-4909.2019.12.2.65-71
E. Radchenko, A. Kolbin
Aim : to assess the socio-economic burden of smoking in the Russian Federation for 2017. Materials and methods . The socio-economic burden was calculated and extrapolated to the entire population of smokers in Russia and then compared with equal sized populations of quitters and non-smokers. Results. In 2017, the burden of tobacco smoking (including the direct costs of medical care and payment for temporary disability, as well as indirect costs - the under-received gross domestic product (GDP) due to temporary disability) was 510.6 billion rubles. The difference between the smokers and the equal-sized non-smoking population is 327.6 billion rubles. The difference between the smokers and the equalsized population of quitters was 216.1 billion rubles. Conclusion. Costs associated with smoking are sizable. Helping quit tobacco smoking (government anti-smoking measures, pharmacotherapy etc.) will not only improve the quality of life and health expectancy of smokers but also save a considerable amount of budget funds.
{"title":"Comparative modeling of socio-economic burden among smokers, nonsmokers and former smokers","authors":"E. Radchenko, A. Kolbin","doi":"10.17749/2070-4909.2019.12.2.65-71","DOIUrl":"https://doi.org/10.17749/2070-4909.2019.12.2.65-71","url":null,"abstract":"Aim : to assess the socio-economic burden of smoking in the Russian Federation for 2017. Materials and methods . The socio-economic burden was calculated and extrapolated to the entire population of smokers in Russia and then compared with equal sized populations of quitters and non-smokers. Results. In 2017, the burden of tobacco smoking (including the direct costs of medical care and payment for temporary disability, as well as indirect costs - the under-received gross domestic product (GDP) due to temporary disability) was 510.6 billion rubles. The difference between the smokers and the equal-sized non-smoking population is 327.6 billion rubles. The difference between the smokers and the equalsized population of quitters was 216.1 billion rubles. Conclusion. Costs associated with smoking are sizable. Helping quit tobacco smoking (government anti-smoking measures, pharmacotherapy etc.) will not only improve the quality of life and health expectancy of smokers but also save a considerable amount of budget funds.","PeriodicalId":201824,"journal":{"name":"FARMAKOEKONOMIKA. Modern Pharmacoeconomic and Pharmacoepidemiology","volume":"80 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2019-07-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"125882122","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2019-07-17DOI: 10.17749/2070-4909.2019.12.2.115-124
F. Gorkavenko, A. Nikitina, E. Saibel, M. V. Avksent’eva, M. Sura, D. Fedyaev
Since generics and biosimilars have entered the Russian market of medications, there are new trends in the general picture of drug prices and consumption. In the present study, we analyze these trends to enable the prediction of possible savings or redistribution of funds in the area of anticancer drug supply, with a special view on highly expensive medications. The aim of this study is to identify changes in the market prices and consumption of medications for the treatment of solid tumors. Materials and methods . We analyzed the dynamics of prices and consumption rates of eight international non-proprietary names (INN) of anticancer drugs, whose generics or biosimilars entered the Russian pharmaceutical market in 2010-2018. Results. With an overall downward trend in prices, differences between individual drugs become apparent with time of joint circulation in the market. The rates of increase/decrease in the prices of the reference drugs that circulate together with generics/biosimilars for at least 4 years, have changed from -50 to +22%; for the respective generics/biosimilars, the figures ranged from -35 to -69%. After generics/biosimilars have entered the market in the Russian Federations, the consumption of the INNs have been increasing, but again with different paces for different drugs. Conclusion . With a general downward trend in prices and an increase in consumption of anticancer medications, there are significant differences in this dynamics as far as individual INNs are concerned. Additional studies are needed to identify factors having an impact on the prices and drug consumption of INNs after their generics/biosimilars have become available. For example, the number of original drugs with expired patent protection may be important. Without a good understanding of such factors, it is difficult to predict the size of savings and the possibility of their redistribution within the budget framework.
{"title":"Dynamics of prices and consumption of anticancer drugs in Russia after their generics and biosimilars became available","authors":"F. Gorkavenko, A. Nikitina, E. Saibel, M. V. Avksent’eva, M. Sura, D. Fedyaev","doi":"10.17749/2070-4909.2019.12.2.115-124","DOIUrl":"https://doi.org/10.17749/2070-4909.2019.12.2.115-124","url":null,"abstract":"Since generics and biosimilars have entered the Russian market of medications, there are new trends in the general picture of drug prices and consumption. In the present study, we analyze these trends to enable the prediction of possible savings or redistribution of funds in the area of anticancer drug supply, with a special view on highly expensive medications. The aim of this study is to identify changes in the market prices and consumption of medications for the treatment of solid tumors. Materials and methods . We analyzed the dynamics of prices and consumption rates of eight international non-proprietary names (INN) of anticancer drugs, whose generics or biosimilars entered the Russian pharmaceutical market in 2010-2018. Results. With an overall downward trend in prices, differences between individual drugs become apparent with time of joint circulation in the market. The rates of increase/decrease in the prices of the reference drugs that circulate together with generics/biosimilars for at least 4 years, have changed from -50 to +22%; for the respective generics/biosimilars, the figures ranged from -35 to -69%. After generics/biosimilars have entered the market in the Russian Federations, the consumption of the INNs have been increasing, but again with different paces for different drugs. Conclusion . With a general downward trend in prices and an increase in consumption of anticancer medications, there are significant differences in this dynamics as far as individual INNs are concerned. Additional studies are needed to identify factors having an impact on the prices and drug consumption of INNs after their generics/biosimilars have become available. For example, the number of original drugs with expired patent protection may be important. Without a good understanding of such factors, it is difficult to predict the size of savings and the possibility of their redistribution within the budget framework.","PeriodicalId":201824,"journal":{"name":"FARMAKOEKONOMIKA. Modern Pharmacoeconomic and Pharmacoepidemiology","volume":"1244 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2019-07-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"127865126","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2019-07-17DOI: 10.17749/2070-4909.2019.12.2.72-84
S. Nedogoda, A. Salasyuk, I. Barykina, V. O. Smirnova
Aim: to assess the economic outcomes of using ceftazidime + avibactam (compared with the recommended treatments) in adult patients with sepsis caused by carbapenem-resistant enterobacteria. Methods. The economic assessment was made using the cost-effectiveness analysis and budget impact analysis. The cost-effectiveness and budget impact analyses were performed using the Microsoft Excel software. Results. The treatment efficacy analysis showed that patients treated with the fixed-dose combination ceftazidime + avibactam had fewer days spent in the ICU and higher clinical cure rates than patients receiving the reference drug combinations (8 vs 18 days and 75% vs 34.8%, respectively, p=0.031). The cost of treatment with ceftazidime + avibactam amounted to 228.3 thousand rubles, which was lower than the cost of using the alternative treatment regimens by 34.5-229.5 thousand rubles or 13.12-50.14%. According to the cost-effectiveness analysis, the use of ceftazidime + avibactam is pharmacoeconomically effective as it reduces the cost of patient clinical cure case by 61-72% (depending on the treatment regimen used); in addition, the ceftazidime + avibactam allows for managing the hospitalized patient at a cost lower by 76270 thousand rubles or 16-40% than the compared treatment. The median economic benefit from using the fixed dose combination ceftazidime + avibactam is 154 thousand rubles (28% savings compared with the current practice). The budget impact analysis showed that the reduction in the health budget burden would reach 29% or 34.3 million rubles in year. The sensitivity analysis confirmed the above results. Conclusion. Based on the obtained results, we conclude that the ceftazidime + avibactam combination in patients with sepsis caused by carbapenem-resistant bacteria is economically preferable as compared with the current antibiotic therapy regimens.
目的:评价头孢他啶+阿维巴坦治疗碳青霉烯耐药肠杆菌所致脓毒症的经济效果(与推荐治疗方法比较)。方法。采用成本效益分析和预算影响分析进行了经济评价。使用Microsoft Excel软件进行成本效益和预算影响分析。结果。疗效分析显示，头孢他啶+阿维巴坦固定剂量联合治疗患者ICU天数少于对照药物联合治疗患者(8天vs 18天，75% vs 34.8%， p=0.031)，临床治愈率较高。使用头孢他啶+阿维巴坦治疗的费用为22.83万卢布，比使用替代治疗方案的费用低34.5- 22.95万卢布或13.12-50.14%。根据成本-效果分析，头孢他啶+阿维巴坦使用具有药物经济效益，可使患者临床治愈病例的成本降低61-72%(取决于所使用的治疗方案);此外，头孢他啶+阿维巴坦治疗住院病人的费用比同类治疗低7627万卢布或16-40%。使用固定剂量头孢他啶+阿维巴坦组合的经济效益中位数为15.4万卢布(与目前的做法相比节省28%)。预算影响分析表明，卫生预算负担将减少29%，即每年减少3 430万卢布。敏感性分析证实了上述结果。结论。基于所获得的结果，我们得出结论，与目前的抗生素治疗方案相比，头孢他啶+阿维巴坦联合治疗碳青霉烯耐药菌引起的脓毒症在经济上更有利。
{"title":"Pharmacoeconomic analysis of ceftazidime+avibactam (Zavicefta®) in the treatment of sepsis caused by carbapenem-resistant enterobacteria","authors":"S. Nedogoda, A. Salasyuk, I. Barykina, V. O. Smirnova","doi":"10.17749/2070-4909.2019.12.2.72-84","DOIUrl":"https://doi.org/10.17749/2070-4909.2019.12.2.72-84","url":null,"abstract":"Aim: to assess the economic outcomes of using ceftazidime + avibactam (compared with the recommended treatments) in adult patients with sepsis caused by carbapenem-resistant enterobacteria. Methods. The economic assessment was made using the cost-effectiveness analysis and budget impact analysis. The cost-effectiveness and budget impact analyses were performed using the Microsoft Excel software. Results. The treatment efficacy analysis showed that patients treated with the fixed-dose combination ceftazidime + avibactam had fewer days spent in the ICU and higher clinical cure rates than patients receiving the reference drug combinations (8 vs 18 days and 75% vs 34.8%, respectively, p=0.031). The cost of treatment with ceftazidime + avibactam amounted to 228.3 thousand rubles, which was lower than the cost of using the alternative treatment regimens by 34.5-229.5 thousand rubles or 13.12-50.14%. According to the cost-effectiveness analysis, the use of ceftazidime + avibactam is pharmacoeconomically effective as it reduces the cost of patient clinical cure case by 61-72% (depending on the treatment regimen used); in addition, the ceftazidime + avibactam allows for managing the hospitalized patient at a cost lower by 76270 thousand rubles or 16-40% than the compared treatment. The median economic benefit from using the fixed dose combination ceftazidime + avibactam is 154 thousand rubles (28% savings compared with the current practice). The budget impact analysis showed that the reduction in the health budget burden would reach 29% or 34.3 million rubles in year. The sensitivity analysis confirmed the above results. Conclusion. Based on the obtained results, we conclude that the ceftazidime + avibactam combination in patients with sepsis caused by carbapenem-resistant bacteria is economically preferable as compared with the current antibiotic therapy regimens.","PeriodicalId":201824,"journal":{"name":"FARMAKOEKONOMIKA. Modern Pharmacoeconomic and Pharmacoepidemiology","volume":"136 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2019-07-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"114453934","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2019-05-22DOI: 10.17749/2070-4909.2019.12.1.48-54
O. Zhukova, I. Nikiforova
Aim: to assess the clinical efficacy of pharmacotherapy regimens using a software package. The article presents a method for assessing the clinical efficacy of pharmacotherapy regimens in children with exacerbation of bronchial asthma (BA); the method is based on comparing the treatment regimens by their significance using the Fishburn method. Materials and methods. We retrospectively analyzed the results of pharmacotherapy in 608 pediatric patients with BA treated in the hospital of Nizhny Novgorod in 2014-2015. We adopted the Fishburn method for determining the weights of each of the used regimens and their subsequent distribution by levels of clinical efficacy. The software was developed using high level C ++ language in the Borland Developer Studio 2006 environment. Results and discussion. The distribution included three levels (high, medium and low) and the subsequent clinical efficacy assessment – two levels (high and low). The high level (0.167-0.250) pertained to the combination of inhaled glucocorticosteroids (IGCS), short-acting β 2- agonists (SABA) and antagonists of leukotriene receptors (ALR), the combination of IGCS, long-acting β 2-agonists (LABA) and ALR, and the combination of IGCS and ALR. The average level (0.083-0.167) was given to the combination of SABA and ALR and the combination of IGCS and LABA. The low level (0-0,083) included the combination of IGCS and SABA and IGCS monotherapy. When classified by two levels of clinical efficacy, the following results were obtained: the high level (0.125-0.250) – the combination of IGCS, SABA and ALR, the combination of IGCS, LABA and ALR, the combination of IGCS and ALR, and the combination of SABA and ALR; the low level (0-0,125) – the combination of IGCS and LABA, the combination of IGCS and SABA, and IGCS monotherapy. The calculating algorithm for the software “Computer program for the distribution of drugs by levels of clinical efficacy” is presented. Conclusion. It has been shown that the combined anti-asthma therapies based on IGCS and ALR are characterized by a high level of clinical efficacy.
{"title":"Evaluation of the clinical efficacy of anti-asthma pharmacotherapy in children using the software package based on the Fishburn method","authors":"O. Zhukova, I. Nikiforova","doi":"10.17749/2070-4909.2019.12.1.48-54","DOIUrl":"https://doi.org/10.17749/2070-4909.2019.12.1.48-54","url":null,"abstract":"Aim: to assess the clinical efficacy of pharmacotherapy regimens using a software package. The article presents a method for assessing the clinical efficacy of pharmacotherapy regimens in children with exacerbation of bronchial asthma (BA); the method is based on comparing the treatment regimens by their significance using the Fishburn method. Materials and methods. We retrospectively analyzed the results of pharmacotherapy in 608 pediatric patients with BA treated in the hospital of Nizhny Novgorod in 2014-2015. We adopted the Fishburn method for determining the weights of each of the used regimens and their subsequent distribution by levels of clinical efficacy. The software was developed using high level C ++ language in the Borland Developer Studio 2006 environment. Results and discussion. The distribution included three levels (high, medium and low) and the subsequent clinical efficacy assessment – two levels (high and low). The high level (0.167-0.250) pertained to the combination of inhaled glucocorticosteroids (IGCS), short-acting β 2- agonists (SABA) and antagonists of leukotriene receptors (ALR), the combination of IGCS, long-acting β 2-agonists (LABA) and ALR, and the combination of IGCS and ALR. The average level (0.083-0.167) was given to the combination of SABA and ALR and the combination of IGCS and LABA. The low level (0-0,083) included the combination of IGCS and SABA and IGCS monotherapy. When classified by two levels of clinical efficacy, the following results were obtained: the high level (0.125-0.250) – the combination of IGCS, SABA and ALR, the combination of IGCS, LABA and ALR, the combination of IGCS and ALR, and the combination of SABA and ALR; the low level (0-0,125) – the combination of IGCS and LABA, the combination of IGCS and SABA, and IGCS monotherapy. The calculating algorithm for the software “Computer program for the distribution of drugs by levels of clinical efficacy” is presented. Conclusion. It has been shown that the combined anti-asthma therapies based on IGCS and ALR are characterized by a high level of clinical efficacy.","PeriodicalId":201824,"journal":{"name":"FARMAKOEKONOMIKA. Modern Pharmacoeconomic and Pharmacoepidemiology","volume":"15 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2019-05-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"115362652","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2019-05-22DOI: 10.17749/2070-4909.2019.12.1.42-47
O. Kirsanova
Photodynamic therapy (PDT) is a relatively new non-surgical treatment for cancer and precancerous conditions. The present review focused on studies using PDT in the treatment of basal cell and squamous cell carcinoma and skin melanoma. The aim was to obtain evidence on the efficacy of PTD in the treatment of skin cancer in patients over 18 years old. To that end, we screened the PubMed database of medical and biological publications and the Cochrane Library without restricting the depth of search. Materials and methods. We evaluated the data of meta-analyses, results of randomized controlled trials (RCTs), and systematic reviews on RCTs, where the overall survival, survival without relapse, and survival without progression were assessed. Results. We have found one systematic review of 27 studies of different designs, one meta-analysis of 5 RCTs, and also five RCTs (1165 participants in total), where the efficacy and safety of PDT in patients with basal cell and squamous cell carcinoma were directly compared to surgical treatment, cryotherapy, and chemo-radiation therapy. In another systematic review, PDT used for squamous cell carcinoma was compared with electro-dissection, cryotherapy, curettage, microsurgery and chemo-radiation therapy. According to our search criteria, no comparative studies on the efficacy and safety of PDT in patients with melanoma were found. Conclusion. The review underscores the efficacy of PDT in patients with both basal cell and squamous cell carcinoma. However, the use of PDT resulted in a lower 5-year survival and a greater recurrence rate compared to the surgical treatment. PDT can be recommended as an alternative to surgery and other treatments for basal cell and squamous cell carcinoma.
{"title":"Efficacy of photodynamic therapy in treatment of adult patients with skin cancer","authors":"O. Kirsanova","doi":"10.17749/2070-4909.2019.12.1.42-47","DOIUrl":"https://doi.org/10.17749/2070-4909.2019.12.1.42-47","url":null,"abstract":"Photodynamic therapy (PDT) is a relatively new non-surgical treatment for cancer and precancerous conditions. The present review focused on studies using PDT in the treatment of basal cell and squamous cell carcinoma and skin melanoma. The aim was to obtain evidence on the efficacy of PTD in the treatment of skin cancer in patients over 18 years old. To that end, we screened the PubMed database of medical and biological publications and the Cochrane Library without restricting the depth of search. Materials and methods. We evaluated the data of meta-analyses, results of randomized controlled trials (RCTs), and systematic reviews on RCTs, where the overall survival, survival without relapse, and survival without progression were assessed. Results. We have found one systematic review of 27 studies of different designs, one meta-analysis of 5 RCTs, and also five RCTs (1165 participants in total), where the efficacy and safety of PDT in patients with basal cell and squamous cell carcinoma were directly compared to surgical treatment, cryotherapy, and chemo-radiation therapy. In another systematic review, PDT used for squamous cell carcinoma was compared with electro-dissection, cryotherapy, curettage, microsurgery and chemo-radiation therapy. According to our search criteria, no comparative studies on the efficacy and safety of PDT in patients with melanoma were found. Conclusion. The review underscores the efficacy of PDT in patients with both basal cell and squamous cell carcinoma. However, the use of PDT resulted in a lower 5-year survival and a greater recurrence rate compared to the surgical treatment. PDT can be recommended as an alternative to surgery and other treatments for basal cell and squamous cell carcinoma.","PeriodicalId":201824,"journal":{"name":"FARMAKOEKONOMIKA. Modern Pharmacoeconomic and Pharmacoepidemiology","volume":"24 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2019-05-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"116031155","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2019-05-22DOI: 10.17749/2070-4909.2019.12.1.55-59
I. Zheleznyakova, L. Kovaleva, T. A. Khelisupali
In the modern economic conditions, the rational planning of costs and the complex process optimization are essential requirements to all organizations. Knowledge of costs is needed to correctly assess the economic performance of an organization. Competent and timely correction of tariffs for the obligatory medical insurance and rationalization of the requested financing of the medical organization depends on this assessment. In the present study, we analyze various methods of personalized cost accounting: the ratio of costs to charges (RCC); relative value unit (RVU); time-driven activity-based costing (TDABC), and the possibility of their adaptation to the specific needs of medical organizations. The personalized cost accounting incorporated into a medical information system allows for controlling, planning and carrying out a close internal management of financial activity. This function helps decision-makers: control the use of funds for medical care provision; increase the efficiency of management decisions; justify the prices of paid medical services; define the deficit and surplus work units; analyze the treatment cost for each patient, considering the diagnosis, method of treatment, age and other classification signs, including the reference to specialized departments; reduce the unnecessary “paper” work load on the medical personnel; model the future needs of the organization in accordance with the planned changes in the hospitalization policy; optimize, control and plan the budget with regard to the established standards of financial expenses. Implementation of this approach is expected to increase the work efficiency in most medical organizations and the entire healthcare system.
{"title":"Individual cost accounting in the management of medical organizations","authors":"I. Zheleznyakova, L. Kovaleva, T. A. Khelisupali","doi":"10.17749/2070-4909.2019.12.1.55-59","DOIUrl":"https://doi.org/10.17749/2070-4909.2019.12.1.55-59","url":null,"abstract":"In the modern economic conditions, the rational planning of costs and the complex process optimization are essential requirements to all organizations. Knowledge of costs is needed to correctly assess the economic performance of an organization. Competent and timely correction of tariffs for the obligatory medical insurance and rationalization of the requested financing of the medical organization depends on this assessment. In the present study, we analyze various methods of personalized cost accounting: the ratio of costs to charges (RCC); relative value unit (RVU); time-driven activity-based costing (TDABC), and the possibility of their adaptation to the specific needs of medical organizations. The personalized cost accounting incorporated into a medical information system allows for controlling, planning and carrying out a close internal management of financial activity. This function helps decision-makers: control the use of funds for medical care provision; increase the efficiency of management decisions; justify the prices of paid medical services; define the deficit and surplus work units; analyze the treatment cost for each patient, considering the diagnosis, method of treatment, age and other classification signs, including the reference to specialized departments; reduce the unnecessary “paper” work load on the medical personnel; model the future needs of the organization in accordance with the planned changes in the hospitalization policy; optimize, control and plan the budget with regard to the established standards of financial expenses. Implementation of this approach is expected to increase the work efficiency in most medical organizations and the entire healthcare system.","PeriodicalId":201824,"journal":{"name":"FARMAKOEKONOMIKA. Modern Pharmacoeconomic and Pharmacoepidemiology","volume":"51 3","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2019-05-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"114102676","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2019-05-22DOI: 10.17749/2070-4909.2019.12.1.5-13
T. A. Oleynikova, D. N. Pozhidaeva, A. Yu. Oreshko
Diseases of the musculoskeletal system and connective tissues are becoming more and more common. As these disorders are associated with temporary or permanent disability as well as a costly treatment, this socially-significant issue requires close attention. Objective: to analyze the prevalence rate of the musculoskeletal and connective tissue disorders in the Russian Federation. The analysis covers the entire country as well as various regional districts with the aim to identify the districts with the most and the least favorable situation and predict the prevalence of these diseases in Russia for 2018-2019. Materials and methods: we analyzed the prevalence of these diseases among the population of the Russian Federation for the period 2012- 2017. In this, we used the statistical reports on musculoskeletal and connective tissue diseases in Russia over 2012-2017 issued by the Ministry of Healthcare of the Russian Federation. To predict the morbidity rate for 2018-2019, statistical processing of the primary survey data was carried out with the help of the «TREND» software. Results: in the period from 2012 to 2017, musculoskeletal system and connective tissue diseases ranked third among the most common diseases. According to the calculated average growth rates, the districts with a relatively high prevalence are the Northwestern and North Caucasian Federal Districts (+ 1.85% and + 1.14%, respectively), and the lowest prevalence was found in the Central Federal District (–1.72%). Among the regions of the Central Federal District, the maximum growth rate was recorded in the Orel Region (+1.97), and the minimum – in the Vladimir Region (–5.47). According to the prognostic models, the prevalence of musculoskeletal diseases per 100 thousand population in the Russian Federation may decrease in 2018-2019 with the following variations: from 12,818,398 to 1,305,502 cases in 2018, and from 12,614,398 up to 12,845.474 in 2019. Conclusion: according to this forecast, the prevalence rates of these diseases will remain high, therefore, further monitoring of this type of morbidity in the Russian Federation is warranted.
{"title":"Prevalence survey of musculoskeletal and connective tissue disorders in the Russian Federation","authors":"T. A. Oleynikova, D. N. Pozhidaeva, A. Yu. Oreshko","doi":"10.17749/2070-4909.2019.12.1.5-13","DOIUrl":"https://doi.org/10.17749/2070-4909.2019.12.1.5-13","url":null,"abstract":"Diseases of the musculoskeletal system and connective tissues are becoming more and more common. As these disorders are associated with temporary or permanent disability as well as a costly treatment, this socially-significant issue requires close attention. Objective: to analyze the prevalence rate of the musculoskeletal and connective tissue disorders in the Russian Federation. The analysis covers the entire country as well as various regional districts with the aim to identify the districts with the most and the least favorable situation and predict the prevalence of these diseases in Russia for 2018-2019. Materials and methods: we analyzed the prevalence of these diseases among the population of the Russian Federation for the period 2012- 2017. In this, we used the statistical reports on musculoskeletal and connective tissue diseases in Russia over 2012-2017 issued by the Ministry of Healthcare of the Russian Federation. To predict the morbidity rate for 2018-2019, statistical processing of the primary survey data was carried out with the help of the «TREND» software. Results: in the period from 2012 to 2017, musculoskeletal system and connective tissue diseases ranked third among the most common diseases. According to the calculated average growth rates, the districts with a relatively high prevalence are the Northwestern and North Caucasian Federal Districts (+ 1.85% and + 1.14%, respectively), and the lowest prevalence was found in the Central Federal District (–1.72%). Among the regions of the Central Federal District, the maximum growth rate was recorded in the Orel Region (+1.97), and the minimum – in the Vladimir Region (–5.47). According to the prognostic models, the prevalence of musculoskeletal diseases per 100 thousand population in the Russian Federation may decrease in 2018-2019 with the following variations: from 12,818,398 to 1,305,502 cases in 2018, and from 12,614,398 up to 12,845.474 in 2019. Conclusion: according to this forecast, the prevalence rates of these diseases will remain high, therefore, further monitoring of this type of morbidity in the Russian Federation is warranted.","PeriodicalId":201824,"journal":{"name":"FARMAKOEKONOMIKA. Modern Pharmacoeconomic and Pharmacoepidemiology","volume":"1 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2019-05-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"129073095","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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