No 5 (2019)

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Articles
Rossiya stanet odnoy iz pervykh stran, pristupivshikh k primeneniyu innovatsionnoy vaktsiny protiv gepatita B
Article E.
Abstract
Российская компания «Фармсинтез» завершила российскую часть клинического исследования III фазы вакцины нового поколения Сай-би-вак (Sci-B-Vac®) против гепатита В. Препарат разработан международной биофармацевтической компанией VBI Vaccines Inc. Исследования в России, Вьетнаме и Израиле были проведены среди участников в возрасте 18-45 лет. Согласно полученным данным, уровень иммунного ответа на вакцинацию более 98% был достигнут уже после введения двух доз Сай-би-вак. Препарат формирует иммунитет против всех трех типов поверхностного антигена гепатита В, в том числе у лиц, не чувствительных к обычным вакцинам, а также у детей, рождающихся от матерей, инфицированных гепатитом В. Благодаря участию в международном исследовании Россия войдет в число стран, которые начнут первыми применять Сай-би-вак. Выход препарата на российский рынок запланирован на 2020 г.
REMEDIUM. 2019;(5):3-6
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Issues of bringing the registration dossier in compliance with the requirements of the rules for registration and expertise in EAEU
Niyazov R.R., Rozhdestvenskiy D.A., Goryachev I.N., Efremova I.N., Kabdenova A.T., Vasiliev A.N., Gavrishina E.V., Dranitsyna M.A., Kulichev D.A.
Abstract
Among the most important requisites for marketing medicines within the Single pharmaceutical market of the Eurasian Economic Union is the bringing into compliance of all pharmaceuticals authorized based on national provisions with the new requirements developed based on international principles and policies for demonstrating drug safety, efficacy, and quality. Statutory wording used to legally outline this procedure needs thorough discussion and clarification and are addressed in this paper. Moreover, we emphasize the paramount importance of ensuring that the basic goals of the Agreement on the common principles and rules of medicinal products circulation within the Eurasian Economic Union are reached. They envisage authorising only those medicines for marketing that demonstrated their safety, efficacy, and quality in accordance with state-of-the-art scientific standards, and the rules for bringing into compliance play an instrumental role here while a formalis-tic approach should be abandoned.
REMEDIUM. 2019;(5):8-20
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Nomenclature of gene-therapy drugs: international experience
Mokhov A.A., Merkulov V.A., Melnikova E.V., Popov P.I., Dudchenko V.V., Koshechkin К.А., Chaplenko A.A., Yavorsky A.N.
Abstract
The development of innovative gene therapy drugs for «personalized» therapy is becoming a megatrend of Biomedicine and the global biopharmaceutical market. Due to the question of the creation of the national nomenclature of these drugs is essential one. The article attempts to summarize the existing international experience in the development of the nomenclature of drug products for gene therapy, as well as to formulate national approaches to the nomenclature of drug products for gene therapy. The analysis shows the feasibility of harmonization of the national nomenclature of gene therapy drugs with the system of international nonproprietary names developed by WHO.
REMEDIUM. 2019;(5):22-26
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«Diabeticheskaya polineyropatiya -ochen' rasprostranennoe zabolevanie, progressirovanie kotorogo mozhno predotvratit'». Interv'yu s Gegikom Galstyanom
Article E.
Abstract
Одним из наиболее частых и опасных осложнений сахарного диабета (СД) признана диабетическая полинейропатия (ДПН) - болезнь, характеризующаяся прогрессирующей гибелью нервных волокон и приводящая пациента к инвалидности. О мерах, позволяющих снизить риск заболеваемости, возможностях современной диагностики и терапии ДПН мы решили поговорить с Гагиком ГАЛСТЯНОМ, заведующим отделением диабетической стопы ФГБУ «Эндокринологический научный центр» Минздрава России, профессором, д.м.н.
REMEDIUM. 2019;(5):28-29
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Diabetic polyneuropathy: from problem to solution
Prozherina J.
Abstract
Diabetes mellitus (DM) is a challenging non-infectious epidemic of the modern world. A steady increase in the number of patients and late diagnosis of the disease predestine the high relevance of this problem. Diabetic polyneuropathy (DPN) is one of the most dangerous complications of diabetes. Choosing the right-pharmacotherapy is important to correctly slow down the progression of DPN [1].
REMEDIUM. 2019;(5):30-33
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Pharmacoeconomic analysis of ALK inhibitors in treatment of advanced or metastatic anaplastic lymphoma kinase-positive non-small cell lung cancer
Belousov D.Y., Cheberda A.E., Afanasieva E.V., Zhuravleva M.V., Sakaeva D.D.
Abstract
Based on both the high effectiveness of anaplastic lymphoma kinase (ALK) inhibitors in treatment of advanced or metastatic anaplastic lymphoma kinase-positive non-small cell lung cancer and high medication costs, the pharmacoeconomic analysis of ceritinib and crizotinib in Russia is needed. Objective: to conduct a cost-effectiveness analysis and budget impact analysis of 1st line treatment (ALK inhibitors - ceritinib vs crizotinib) of advanced or metastatic anaplastic lymphoma kinase-positive non-small cell lung cancer in Russian healthcare circumstances. Methods: To conduct cost-effectiveness analysis (including cost-utility analysis) and budget impact analysis, a Markov model was developed. Using results of matching adjusted indirect comparison (MAIC), the model compared progression-free survival, life years (LY), quality adjusted life years gained (QALY) and treatment costs. Cost-effectiveness analysis considered direct medical costs (costs of medication treatment with ceritinib and crizotinib; costs of adverse event management; costs of inpatient and outpatient treatment due to progression of the disease). Budget-impact analysis considered only medication treatment with ceritinib and crizotinib costs. Time horizon was limited to local state budget planning approach - three years. The number of patients for budget impact analysis was derived from local statistics. Results: Annual cost of treatment with ceritinib (1,36 Mln. RUB or $20,8 thousands per patient) is 55% less than with crizotinib (3,03 Mln RUB or $55,05 thousands per patient). Total costs of three-years' treatment with ceritinib (2,1 Mln. RUB or $32,5 thousands per patient) is 41% less than with crizotinib (3,6 Mln. RUB or $55,05 thousands per patient). Lower costs together with higher PFS, LY and QALY led to dominant cost-effectiveness of ceritinib in comparison with crizotinib. In case of concurrent increasing of using ceritinib in clinical practice up to 45% and decreasing of using crizotinib down to 25%, the total medication cost savings in group of 240 patients will be up to 56,5 Mln RUB or $864,5 thousands. Conclusion: Dominant cost-effectiveness and significant budget savings of ceritinib in comparison with crizotinib is the rationale for increasing prescribing of the former in 1st line treatment of advanced or metastatic anaplastic lym-phoma kinase-positive non-small cell lung cancer in Russia.
REMEDIUM. 2019;(5):34-44
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Improving and bringing together approaches to education as a factor for the harmonious development of good clinical practice (GCP)
Kubar O.I., Klingmann I., Balincourt C.d., Sampson H.
Abstract
The article presents a detailed analysis of the possibilities for the harmonious development of good clinical practice (GCP) to form objective standards for international cooperation in the circulation of medicines and other medical products. It reflects unity in the issues of bringing together the goals of cooperation recognized by the Eurasian Economic Union (EAEU) and the leading authorized international agencies in order to ensure fair and universal access to the best medical achievements. The authors showed significance and influence of the qualification component of clinical studies on the quality of the results and identified their direct dependence on the level of primary and subsequent education. A review of the modern training system for specialists dealing with the clinical studies. The article objectively identified limiting and future trends in GCP education and training. The possibility of differentiated GCP education focused on various levels of required competences in the format of participation in clinical studies has been demonstrated on the basis of the current developments of the European Forum for Good Clinical Practice (EFGCP). The paper presented accessible arsenal of educational opportunities and formed the prospects for achieving harmonization and rapprochement in educational issues on the GCP.
REMEDIUM. 2019;(5):46-63
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Analysis of compliance with the rules of vacation prescription medicines from pharmacies
Moroz T.L., Ryzhova O.A.
Abstract
The purpose of the study To analyze the causes of violations of the rules of prescription drugs from pharmacy organizations. Research problem. The problem of prescription drugs in the Russian Federation is very acute. The population of the Russian Federation the main part of medicines, except subject to subject-quantitative accounting and received preferential categories of patients, acquires in pharmacies without a doctor's prescription, which leads to total self-treatment of the population, the consequence of which is a decrease in the safety of the use of medicines. This article is devoted to the study of the level of awareness of pharmaceutical specialists on compliance with the requirements of existing regulations for the release of prescription drugs from pharmacies. Methods. The study was conducted by an anonymous survey of 100 pharmaceutical specialists engaged in the sale of medicines from pharmacies in Irkutsk. Results. The most frequent violation is the release of prescription medicines without a doctor's prescription. The survey of specialists showed that only 33% of respondents know the current regulatory document on the issue of medicines, 40% of specialists as a source of information about medicines called the Internet and 40% of respondents do not consider it necessary to release prescription drugs strictly according to prescriptions. 42% of respondents do not know the rules of registration of prescriptions for medicines containing narcotic drugs, psychotropic substances and subject to subject-quantitative accounting. Among the factors that lead to violation of the rules of medicines, 67% of respondents named the dependence of wages on turnover and 57% - high competition between pharmacies. Conclusion The widespread non-compliance with the rules of prescription medicines from pharmacies dramatically reduces the safety of their use by patients, leading to the further spread of self-medication.
REMEDIUM. 2019;(5):52-55
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Methodical approaches to the development of the structural-logical scheme of personalized therapeutic drug management for cancer patients
Tarabukina S.M., Moshkova L.V., Chertovskikh Y.V.
Abstract
The article investigated the issues of the arrangement of personalized selection of drugs for cancer patients. The potential economic efficiency of the use of molecular genetic studies for the prescription of drugs and the cost-effectiveness was calculated using antitumor drugs as an example. A sociological survey of medical professionals on personalized selection of drugs in medical practice was conducted. A statistical link has been established between the practice of prescribing drugs according to the pharmacogenetic testing results and such indicators as side effects monitoring, pharmacoeconomic analysis of the use of drugs in medical organizations. The structural-logical scheme of interaction between the subjects of healthcare and the drug provision system for personalized therapeutic drug management for cancer patients has been developed based on scientific research.
REMEDIUM. 2019;(5):56-63
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Monthly review: production, investment, finance
Romanova S.
Abstract
Performance analysis of industry enterprises is conducted using the national statistics reports: Form No. P-1, term (monthly), Form No. P-2 Information on Investments in Non-Financial Assets (quarterly), Form No. P-3 Information on Company Financial Status (monthly).
REMEDIUM. 2019;(5):66-76
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Monthly review: business activity of industry enterprises
Romanova S.
Abstract
The rating was carried out using the national accounting statements of top 150 industry enterprises.
REMEDIUM. 2019;(5):77-80
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Mezhdunarodnye farmproizvoditeli v Rossii: missiya vypolnyaetsya
Bykovchenko I.
Abstract
В середине мая в Санкт-Петербурге в ходе XXV Российского фармацевтического форума состоялся брифинг Ассоциации международных фармпроизводителей (AIPM), отмечающей в этом году 25-летие. Участники обменялись мнениями о роли ассоциации в развитии национальной экономики и повышении уровня российского здравоохранения, обозначили круг актуальных проблем и стоящие перед индустрией ключевые задачи.
REMEDIUM. 2019;(5):82-83
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Uluchshit' prognoz onkologicheskikh bol'nykh
Shirokova I.
Abstract
Компания Bayer в борьбе с трудноизлечимыми формами рака направляет свои усилия на развитие таргетной альфа-терапии (ТаТ). На семинаре, состоявшемся в апреле 2019 г. в Осло, представители компании сообщили о значительных достижениях в данной области, а также о новых перспективных направлениях исследований.
REMEDIUM. 2019;(5):84-86
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Ot idey k voploshcheniyu
Shirokova I.
Abstract
Более 60 журналистов из 19 стран мира собрались в апреле на традиционной конференции компании «Берингер Ингельхайм». В ходе встречи в Ингельхайме руководители компании проинформировали гостей о результатах ее работы за последний год, приоритетных направлениях деятельности, а также поделились опытом применения технологий искусственного интеллекта - инструмента, позволяющего решать ранее не разрешимые проблемы медицины и фармацевтики.
REMEDIUM. 2019;(5):87-89
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TOP-pozitsii. Pokazateli vedushchikh mirovykh i otechestvennykh proizvoditeley i distrib'yuterov
Article E.
Abstract
Показатели ведущих мировых и отечественных производителей и дистрибьютеров
REMEDIUM. 2019;(5):90-95
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