Pub Date : 2022-05-01DOI: 10.37489/2588-0519-2022-1-64-71
V. A. Sergeeva, T. Lipatova
{"title":"Lifestyle Changes in Medical Students during the COVID-19 Pandemic","authors":"V. A. Sergeeva, T. Lipatova","doi":"10.37489/2588-0519-2022-1-64-71","DOIUrl":"https://doi.org/10.37489/2588-0519-2022-1-64-71","url":null,"abstract":"","PeriodicalId":326764,"journal":{"name":"Kachestvennaya Klinicheskaya Praktika = Good Clinical Practice","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2022-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"133569892","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 : 2022-04-30DOI: 10.37489/2588-0519-2022-1-17-29
A. Kolbin, Y. Gomon, M. Proskurin, Y. E. Balikina
{"title":"Clinical-economic analysis of the target therapy in severe atopic dermatitidis in adults","authors":"A. Kolbin, Y. Gomon, M. Proskurin, Y. E. Balikina","doi":"10.37489/2588-0519-2022-1-17-29","DOIUrl":"https://doi.org/10.37489/2588-0519-2022-1-17-29","url":null,"abstract":"","PeriodicalId":326764,"journal":{"name":"Kachestvennaya Klinicheskaya Praktika = Good Clinical Practice","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2022-04-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"116563967","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 : 2022-04-30DOI: 10.37489/2588-0519-2022-1-30-40
O. Ivakhnenko, E. Derkach, V. Krysanova, A. D. Ermolaeva, K. Kokushkin
{"title":"Mirabegron: pharmacoeconomic aspects of the use of the drug for the treatment of overactive bladder syndrome","authors":"O. Ivakhnenko, E. Derkach, V. Krysanova, A. D. Ermolaeva, K. Kokushkin","doi":"10.37489/2588-0519-2022-1-30-40","DOIUrl":"https://doi.org/10.37489/2588-0519-2022-1-30-40","url":null,"abstract":"","PeriodicalId":326764,"journal":{"name":"Kachestvennaya Klinicheskaya Praktika = Good Clinical Practice","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2022-04-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"131376115","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 : 2022-04-30DOI: 10.37489/2588-0519-2022-1-41-52
M. Zhuravleva, G. Kukushkin, E. Luchinina, T. Shelekhova, T. Kameneva, E. V. Kuznetsova, E. A. Luchinin
{"title":"Ademetionine treatment cost analysis of patients with intrahepatic cholestasis and non-alcoholic fatty disease","authors":"M. Zhuravleva, G. Kukushkin, E. Luchinina, T. Shelekhova, T. Kameneva, E. V. Kuznetsova, E. A. Luchinin","doi":"10.37489/2588-0519-2022-1-41-52","DOIUrl":"https://doi.org/10.37489/2588-0519-2022-1-41-52","url":null,"abstract":"","PeriodicalId":326764,"journal":{"name":"Kachestvennaya Klinicheskaya Praktika = Good Clinical Practice","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2022-04-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"131893387","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 : 2022-04-28DOI: 10.37489/2588-0519-2022-1-4-16
A. Kolbin, A. A. Kurilev, Y. E. Balikina, M. Proskurin
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.
{"title":"The clinical-economic characteristic of current basis-bolus insulin therapy schemes in diabetes mellitus type 1 in adults","authors":"A. Kolbin, A. A. Kurilev, Y. E. Balikina, M. Proskurin","doi":"10.37489/2588-0519-2022-1-4-16","DOIUrl":"https://doi.org/10.37489/2588-0519-2022-1-4-16","url":null,"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.","PeriodicalId":326764,"journal":{"name":"Kachestvennaya Klinicheskaya Praktika = Good Clinical Practice","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2022-04-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"129339264","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 : 2022-02-25DOI: 10.37489/2588-0519-2022-1-72-84
A. S. Fedorenko, A. Burbello, E. L. Lataria, O. V. Granatovich, M. Pokladova
{"title":"Issues of drug circulation in a hospital: how to optimize work in a medical information system","authors":"A. S. Fedorenko, A. Burbello, E. L. Lataria, O. V. Granatovich, M. Pokladova","doi":"10.37489/2588-0519-2022-1-72-84","DOIUrl":"https://doi.org/10.37489/2588-0519-2022-1-72-84","url":null,"abstract":"","PeriodicalId":326764,"journal":{"name":"Kachestvennaya Klinicheskaya Praktika = Good Clinical Practice","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2022-02-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"116315004","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 : 2022-02-13DOI: 10.37489/2588-0519-2021-4-75-79
M. G. Malaev
The use of different methods for analyzing the procurement of drugs for state needs made it possible to reveal the excessive range of drugs included in state contracts, as well as the low efficiency of the use of funds.
使用不同的方法分析国家需要的药品采购,可以揭示国家合同所包括的药品范围过大,以及资金使用效率低下。
{"title":"Analysis of the effectiveness of the use of financial resources in the procurement of pharmaceuticals for state needs","authors":"M. G. Malaev","doi":"10.37489/2588-0519-2021-4-75-79","DOIUrl":"https://doi.org/10.37489/2588-0519-2021-4-75-79","url":null,"abstract":"The use of different methods for analyzing the procurement of drugs for state needs made it possible to reveal the excessive range of drugs included in state contracts, as well as the low efficiency of the use of funds.","PeriodicalId":326764,"journal":{"name":"Kachestvennaya Klinicheskaya Praktika = Good Clinical Practice","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2022-02-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"124589450","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 : 2022-02-13DOI: 10.37489/2588-0519-2021-4-27-43
O. Reshetko, A. I. Grishin
Relevance. According to statistics of the World Health Organization, at least half of the world’s adult population experienced headaches at least once a year. Patients suffering from headaches do not always have the opportunity to visit a doctor, therefore, an important role in helping these patients is assigned to pharmacists. Purpose. Based on the pharmacoepidemiological study to identify the features of providing pharmaceutical care to patients with headache in pharmacies in the issue of rationality of recommendations of pharmaceutical workers. Materials and methods. A pharmacoepidemiological study was conducted based on a survey of 153 pharmaceutical workers (Saratov) using a specially developed questionnaire that includes free-form questions with a simulated situation. The data was processed using Microsoft Excel 2010 and STATISTIKA 6.0. Results Of the groups recommended to visitors, INNs in the group «Nonsteroidal anti-inflammatory and antirheumatic drugs [M01A]» account for 45.0 % of all INNs, and the group «Analgesics [N02]» - 55.0 %. Ibuprofen (62.8 %) and the combination of drotaverine + caffeine + naproxen + paracetamol + phenylephrine (41.2 %) were noted as the most frequently recommended. A visit to a doctor was recommended by the majority of respondents (52.3 %, n=153) in the case of a patient with a headache accompanied by nausea and vomiting. Ibuprofen (90.8 %) or paracetamol (45.8 %), moreover in the form of suspension or suppositories, are the preferred recommendations for headache in children under 3 years of age (n=131). Paracetamol in combinations (69.2 %) prevails as the first recommendation for headache associated with acute respiratory viral infections (n??=146). Non-selective NSAIDs for a patient with gastrointestinal complications could be recommended by 43.4 % of specialists (n=113). The NSAID recommendation is the most frequent (51.8 %, n=110) in the case of an 80-year-old patient without concomitant diseases. Paracetamol (50.0 %) or ibuprofen (34.7 %) would be more often recommended by pharmaceutical workers for a pregnant woman with headache (n=98). In case of headache after trauma, 47.1 % recommend a visit to a doctor (n=153). Conclusion. The frequent recommendation of combined analgesics and their association with the development of drug-induced headaches indicates the need for careful recommendation of these drugs. Not always correct recommendations indicate the need to increase the level of professional knowledge, study clinical recommendations for the therapy and diagnosis of cephalgia, which can make it possible to make a rational choice of the drug, initially assume that the visitor has conditions that require a visit to a doctor, and ultimately improve the quality of pharmaceutical care.
{"title":"The rationality of recommendations of drugs for patients with cephalgia in simulated situations in the pharmacy","authors":"O. Reshetko, A. I. Grishin","doi":"10.37489/2588-0519-2021-4-27-43","DOIUrl":"https://doi.org/10.37489/2588-0519-2021-4-27-43","url":null,"abstract":"Relevance. According to statistics of the World Health Organization, at least half of the world’s adult population experienced headaches at least once a year. Patients suffering from headaches do not always have the opportunity to visit a doctor, therefore, an important role in helping these patients is assigned to pharmacists. Purpose. Based on the pharmacoepidemiological study to identify the features of providing pharmaceutical care to patients with headache in pharmacies in the issue of rationality of recommendations of pharmaceutical workers. Materials and methods. A pharmacoepidemiological study was conducted based on a survey of 153 pharmaceutical workers (Saratov) using a specially developed questionnaire that includes free-form questions with a simulated situation. The data was processed using Microsoft Excel 2010 and STATISTIKA 6.0. Results Of the groups recommended to visitors, INNs in the group «Nonsteroidal anti-inflammatory and antirheumatic drugs [M01A]» account for 45.0 % of all INNs, and the group «Analgesics [N02]» - 55.0 %. Ibuprofen (62.8 %) and the combination of drotaverine + caffeine + naproxen + paracetamol + phenylephrine (41.2 %) were noted as the most frequently recommended. A visit to a doctor was recommended by the majority of respondents (52.3 %, n=153) in the case of a patient with a headache accompanied by nausea and vomiting. Ibuprofen (90.8 %) or paracetamol (45.8 %), moreover in the form of suspension or suppositories, are the preferred recommendations for headache in children under 3 years of age (n=131). Paracetamol in combinations (69.2 %) prevails as the first recommendation for headache associated with acute respiratory viral infections (n??=146). Non-selective NSAIDs for a patient with gastrointestinal complications could be recommended by 43.4 % of specialists (n=113). The NSAID recommendation is the most frequent (51.8 %, n=110) in the case of an 80-year-old patient without concomitant diseases. Paracetamol (50.0 %) or ibuprofen (34.7 %) would be more often recommended by pharmaceutical workers for a pregnant woman with headache (n=98). In case of headache after trauma, 47.1 % recommend a visit to a doctor (n=153). Conclusion. The frequent recommendation of combined analgesics and their association with the development of drug-induced headaches indicates the need for careful recommendation of these drugs. Not always correct recommendations indicate the need to increase the level of professional knowledge, study clinical recommendations for the therapy and diagnosis of cephalgia, which can make it possible to make a rational choice of the drug, initially assume that the visitor has conditions that require a visit to a doctor, and ultimately improve the quality of pharmaceutical care.","PeriodicalId":326764,"journal":{"name":"Kachestvennaya Klinicheskaya Praktika = Good Clinical Practice","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2022-02-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"134345732","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 : 2022-02-13DOI: 10.37489/2588-0519-2021-4-53-59
A. Pereverzev, O. Ostroumova
The use of many drugs is associated with the risk of adverse drug reactions (ADRs), including those that increase mortality and / or morbidity and / or seek medical help or hospitalization, so called «drug-induced diseases» (DID). There is a number of factors that increase the risk of DID (risk factors) including comorbid diseases (for example, chronic kidney disease, hepatic impairment, obesity etc.). These pathologic conditions induce changes in pharmacokinetics (PK) and pharmacodynamics of drugs, thereby increasing the risk of ADRs. One of these diseases is heart failure (HF). Most studies of PK changes were conducted among patients with LVEF from 40 to 45 %, and excluded patients with concomitant diseases that could affect the PK of drugs (for example, serious liver and / or kidney diseases), therefore in polymorbid patients, trial findings may not be applicable. HF may be associated with a decrease in bioavailability, a decrease in volume of distribution, a change in the activity of cytochrome P450 isoenzymes, etc. Individual dose and dosage regimen adjustment can significantly reduce risks, improve the quality of medical care and improve the prognosis in patients with heart failure.
{"title":"Heart failure as a risk factor of adverse drug reactions. Part 1: potential changes in pharmacokinetics","authors":"A. Pereverzev, O. Ostroumova","doi":"10.37489/2588-0519-2021-4-53-59","DOIUrl":"https://doi.org/10.37489/2588-0519-2021-4-53-59","url":null,"abstract":"The use of many drugs is associated with the risk of adverse drug reactions (ADRs), including those that increase mortality and / or morbidity and / or seek medical help or hospitalization, so called «drug-induced diseases» (DID). There is a number of factors that increase the risk of DID (risk factors) including comorbid diseases (for example, chronic kidney disease, hepatic impairment, obesity etc.). These pathologic conditions induce changes in pharmacokinetics (PK) and pharmacodynamics of drugs, thereby increasing the risk of ADRs. One of these diseases is heart failure (HF). Most studies of PK changes were conducted among patients with LVEF from 40 to 45 %, and excluded patients with concomitant diseases that could affect the PK of drugs (for example, serious liver and / or kidney diseases), therefore in polymorbid patients, trial findings may not be applicable. HF may be associated with a decrease in bioavailability, a decrease in volume of distribution, a change in the activity of cytochrome P450 isoenzymes, etc. Individual dose and dosage regimen adjustment can significantly reduce risks, improve the quality of medical care and improve the prognosis in patients with heart failure.","PeriodicalId":326764,"journal":{"name":"Kachestvennaya Klinicheskaya Praktika = Good Clinical Practice","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2022-02-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"132585554","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 : 2022-02-13DOI: 10.37489/2588-0519-2021-4-16-26
G. I. Syraeva, A. Kolbin
The group of non-steroidal anti-inflammatory drugs has occupied one of the leading positions in terms of demand by the population over the past decade. This fact is explained by non-prescription sale, a wide range of purposes and an affordable price range. The lack of proper control over the use of non-steroidal anti-inflammatory drugs (NSAIDs) greatly complicates the assessment of safety, timely detection and prevention of events associated with patient’ safety. Target. Evaluation of data from the national pharmacovigilance database of the safety of non-steroidal anti-inflammatory drugs. Materials and methods. This is a cross-sectional study covering the period from 2010 till 2020. The assessment of the safety profile of international non-proprietary names (INN) from the group of NSAIDs at the post-registration stage was carried out according to the data of uploading the national database (Automated Information System of Roszdravnadzor; AIS RZN), as well as PubMed, Medline, Google Scholar, Elibrary databases. Conclusions. Over a ten-year period, the number of registered spontaneous messages was 8,334. With regard to the three international generic names, the number of adverse drug reactions prevails - this is metamizole (1875 (22.5 %)), acetylsalicylic acid (1716 (20.6 %)), diclofenac (979 (11.7 %)). The main system organ class with safety-related events are described for skin and subcutaneous structures. This fact is not consistent with the data of reference sources of information, which indicates the ineffectiveness of post-marketing observations by marketing authorization holders.
{"title":"Nonsteroidal anti-inflammatory drugs’ adverse drug reactions: 10 years of national database data","authors":"G. I. Syraeva, A. Kolbin","doi":"10.37489/2588-0519-2021-4-16-26","DOIUrl":"https://doi.org/10.37489/2588-0519-2021-4-16-26","url":null,"abstract":"The group of non-steroidal anti-inflammatory drugs has occupied one of the leading positions in terms of demand by the population over the past decade. This fact is explained by non-prescription sale, a wide range of purposes and an affordable price range. The lack of proper control over the use of non-steroidal anti-inflammatory drugs (NSAIDs) greatly complicates the assessment of safety, timely detection and prevention of events associated with patient’ safety. Target. Evaluation of data from the national pharmacovigilance database of the safety of non-steroidal anti-inflammatory drugs. Materials and methods. This is a cross-sectional study covering the period from 2010 till 2020. The assessment of the safety profile of international non-proprietary names (INN) from the group of NSAIDs at the post-registration stage was carried out according to the data of uploading the national database (Automated Information System of Roszdravnadzor; AIS RZN), as well as PubMed, Medline, Google Scholar, Elibrary databases. Conclusions. Over a ten-year period, the number of registered spontaneous messages was 8,334. With regard to the three international generic names, the number of adverse drug reactions prevails - this is metamizole (1875 (22.5 %)), acetylsalicylic acid (1716 (20.6 %)), diclofenac (979 (11.7 %)). The main system organ class with safety-related events are described for skin and subcutaneous structures. This fact is not consistent with the data of reference sources of information, which indicates the ineffectiveness of post-marketing observations by marketing authorization holders.","PeriodicalId":326764,"journal":{"name":"Kachestvennaya Klinicheskaya Praktika = Good Clinical Practice","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2022-02-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"128959504","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}