No 7-8 (2018)

Full Issue

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Articles
Minzdrav predstavil zakonoproekt o dekriminalizatsii oshibok pri rabote s obezbolivayushchimi
Article E.
Abstract
Минздрав РФ опубликовал для общественного обсуждения проект закона о декриминализации ошибок медицинских и фармацевтических работников в обращении с наркотическими обезболивающими. Ведомство предлагает освобождать от уголовной ответственности медработников, добровольно сообщивших об ошибке, активно способствовавших расследованию, возместивших ущерб или иным образом возместивших причиненный вред, при условии, что в их действиях не содержится иного состава преступления. Поручение о декриминализации незначительных нарушений при работе с наркотическими лекарственными препаратами в декабре 2017 г. дал премьер Дмитрий Медведев. Сейчас за утрату наркотических препаратов в результате нарушений правил их хранения или перевозки медработникам грозит уголовная ответственность по ст. 228.2 УК и наказание в виде заключения на срок до трех лет.
REMEDIUM. 2018;(7-8):4-5
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Regulatory aspects of marketing authorization of generic and hybrid medicinal products in the Eurasian Economic Union
Niyazov R.R., Rozhdestvenskiy D.A., Vasiliev A.N., Gavrishina E.V., Dranitsyna М.А., Kulichev D.A.
Abstract
A robust methodological basis for the placing generic and hybrid medicinal products on the market has been established in the Eurasian Economic Union (EAEU). Since the concepts of generic medicinal products and hybrid medicinal products are regulatory in their nature and serve as a tool for the simplified access on the pharmaceutical market for medicinal products with established safety and efficacy, it is worth discussing the terms and definitions, criteria for recognizing generic or hybrid products, considering regulatory conditions for the development, and applying for the marketing authorization, of generics and hybrids as well as comparing U. S., EU and EAEU legal provisions governing granting marketing authorization for these two group of products that are important for the healthcare.
REMEDIUM. 2018;(7-8):6-19
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Protected dosage forms: foreign experience and prospects for introducing regulation in Russia
Borzova M.
Abstract
Protected dosage forms are an innovative solution to reduce the possibility of using opioid pain medications for purposes not related to treatment and/or management of pain. Today, the regulatory authorities of some countries are considering the development of the use of protected dosage forms as one of the priority areas of national strategies to improve the legislation on the management of pain medications. The list of PDF in the developed law enforcement systems remains open, and various countries detail the applicable rules of law in varying degrees.
REMEDIUM. 2018;(7-8):20-28
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Medical information system's Big Data Analytics based on Cluster analysis: patients with Diabetes Mellitus type 1
Minushkina L.O., Kolesnichenko O.Y., Mazelis A.L., Soldatov D.A., Kolesnichenko Y.Y., Martynov A.V., Pulit V.V., Dolzhenkov A.N., Grigorevsky I.N., Mazelis L.S.
Abstract
Cluster analysis of medical information system’s records used to find direct and indirect indications to differences in the hospital management of patients with Diabetes Mellitus type 1, according to the prescribed diagnostic examinations and surgery. This approach allows to investigate disease’s pathogenetic mechanisms and provides predictive analytics of patients flow for more personalized treatment. Five clusters have been identified. Open international genetic databases were analyzed additionally in terms of some key pathogenesis molecular complexes. All data was compared and connected continuum of the Diabetes Mellitus type 1 pathogenetic cascade was proposed.
REMEDIUM. 2018;(7-8):30-40
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Quadrivalent influenza vaccines: an opportunity to reduce the influenza burden
Kaplya-Bubenets V.
Abstract
Annual epidemics of influenza poses a serious risk to health of all mankind. According to WHO estimates, seasonal flu epidemics result in three to five million cases of severe illness and between 250000 and 500 000 deaths worldwide. Seasonal influenza spreads easily, with rapid transmission in crowded areas, it is difficult to protect from it, so vaccination remains the most effective method for preventing infection. For many years, the composition of influenza vaccines included two subtypes A and one type B of influenza viruses. However, since the 2012-2013 season, WHO recommends that the fourth component, the antigens of the second influenza B virus, should be included. The quadrivalent vaccines are expected to provide broader protection against infections caused by influenza B viruses.
REMEDIUM. 2018;(7-8):42-43
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Grigoriy Krivoborodov: «Samoe vazhnoe pri vybore terapii - ponimat', kakie imenno simptomy bespokoyat patsienta»
Article E.
Abstract
Рост населения планеты в возрасте после 60 лет неизбежно приводит к увеличению случаев заболеваемости доброкачественной гиперплазией предстательной железы (ДГПЖ) - одним из самых распространенных урологических заболеваний пожилых мужчин. Об особенностях ДГПЖ, проблемах, связанных с развитием этого заболевания, а также о современной диагностике и подходах к лечению мы решили поговорить с Григорием Кривобородовым, профессором кафедры урологии и андрологии РНИМУ им. Н.И. Пирогова, заведующим урологическим отделением РНКЦ геронтологии, председателем Общества нейроурологии, д.м.н.
REMEDIUM. 2018;(7-8):44-47
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Overview of the German pharmacy market
Trofimova E.O., Kareva N.N.
Abstract
The paper represents the main characteristics of the pharmacy market in Germany, including pharmacies' operations within the health insurance system. There was noted the tendency for the pharmacies' number reduction as a result of an unfavorable economic situation and contain of the drugs costs in the statutory health insurance. An assumption is made that the problem of regulation of the pharmacies' number in Russia (a specific indicator of pharmacies' number per population in Russia is about twice as large as in Germany) can be solved within the introduction of the medicines insurance coverage.
REMEDIUM. 2018;(7-8):50-56
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Conceptual issues of the federal state supervision reform in the sphere of circulation of drugs
Shevyrev D.N.
Abstract
The article deals with topical issues of the federal state supervision reform in the sphere of circulation of drugs. It has been stated that the existing sectoral regulatory and legal regulation does not correspond to the conceptual foundations for bringing to administrative responsibility that are enshrined in the Administrative Offense Code of the Russian Federation The sectoral legislation in the sphere of circulation of drugs requires a more detailed study. The author proposes his interpretation of risk categories depending on the potential negative consequences, taking into account the functioning administrative and legal institute of standardization and certification.
REMEDIUM. 2018;(7-8):57-59
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On-line monitoring of electronic resources in the activities of the qualified person responsible for pharmacovigilance
Matveev A.V., Krasheninnikov A.E., Egorova E.A.
Abstract
The regular monitoring of medicinal product (MP) safety is one of the requirements of the Good Pharmacovigilance Practices (GVP) for marketing authorization holders. The search and study of information about adverse reactions (AR) of medicinal products by pharmaceutical manufacturers allow us to constantly update the AR database, identify changes in the "benefit-risk" ratio when using MPs, and conduct the qualitative assessment of the safety profile.
REMEDIUM. 2018;(7-8):60-64
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Monthly review: production, investment, finance
Romanova S.
Abstract
The industry enterprises performance is analysed using the national statistical reporting: Form P-1 urgent (monthly), Form No. P-2 "Information on Investments in Non-Financial Assets" (quarterly), Form No. P-3 "Information on Company Financial Status" (monthly).
REMEDIUM. 2018;(7-8):66-74
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Monthly review: business activity of industry enterprises
Romanova S.
Abstract
The rating was prepared using the national accounting statements of over 100 profitable industry enterprises.
REMEDIUM. 2018;(7-8):76-81
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Razvivat' biznes, razvivaya otrasl'
Shirokova I.
Abstract
В последнее время в мире становится все популярнее интегративный подход к лечению многих заболеваний, объединяющий основную (классическую) и дополнительную (комплементарную) терапию. О том, какие перспективы могут открываться на базе традиционных лекарственных формул и почему французская гомеопатия популярна в мире, шла речь на пресс-конференции компании Boiron, состоявшейся в июне этого года во французском Мессими.
REMEDIUM. 2018;(7-8):84-86
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TOP-pozitsii. Pokazateli vedushchikh mirovykh i otechestvennykh proizvoditeley i distrib'yuterov
Article E.
Abstract
Производство отдельных групп медицинских изделий за май 2018 г. Динамика производства основных ФТГ за май 2018 г. Производство отдельных групп медицинских изделий за июнь 2018 г. Динамика производства основных ФТГ за июнь 2018 г. ТОП-20 МНН ГЛС по объему импорта ГЛС в Россию в марте 2018 г. ТОП-20 АТС-групп 2-го уровня по объему импорта ГЛС в Россию в марте 2018 г. ТОП-20 АТС-ГРУПП 2-го уровня по объему экспорта ГЛС из России в марте 2018 г. 20 крупнейших рекламодателей и рекламируемых марок лекарственных препаратов в Российских СМИ* в июне 2018 г.
REMEDIUM. 2018;(7-8):88-95
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