No 9 (2020)

Full Issue

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Articles
Sistema MDLP perevoditsya na uvedomitel'nyy rezhim raboty
Article E.
Abstract
Система маркировки лекарственных препаратов временно переводится в уведомительный режим работы в аптечном и дистрибьюторском сегментах. С момента запуска системы маркировки было зафиксировано два сбоя, которые были устранены оператором в течение суток. Однако до сих пор остаются проблемы, связанные с недостаточной технической готовностью дистрибьюторов и ряда аптечных организаций к работе с маркированными препаратами.
REMEDIUM. 2020;(9):3-3
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Comparison and analysis of the fda approved orphane drugs register and the vital and essential drugs list of the Russian Federation
Yurochkin D.S., Leshkevich A.A., Golant Z.M., Narkevich I.A.
Abstract
The article presents the results of a comparison of the Orphan Drugs Register approved for use in the United States and the 2020 Vital andEssential Drugs List approved on October 12, 2019 by Order of the Government of the Russian Federation No. 2406-r. The comparison identified305 international non-proprietary names relating to the main and/or auxiliary therapy for rare diseases. The analysis of the market of drugs included in the Vital and Essential Drugs List, which can be used to treat rare (orphan) diseases in Russia was conducted.The analysis results allowed to draw the following conclusions:• the nomenclature of drugs used to treat rare diseases is much wider than the list of drugs purchased as part of personalized purchases at the federal and regional levels, which determines the task to formalize the therapy regimens and obligations in relation to patients with rare diseases under the state guarantee program;• comparison of the existing drug registers in the world practice and rare diseases themselves should form indicators for government programs to determining the need for financing the drug therapy, which will directly affect the marketing authorisation of new drugs, as well as the use of alternative mechanisms, in particular compulsory licensing;• the high cost of original drugs to treat rare diseases affords additional grounds for the introduction of procedures and mechanisms to assess healthcare technologies at the marketing authorization stage or in case of implementation of mechanisms to localize production and technology transfer in order to reduce the costs of this therapy;• the Strategy for the Pharmaceutical Provision of the Population of the Russian Federation for the Period until 2025 requires the development and formation of the National Formulary, which should include matching rare (orphan) diseases with a specific type of drug therapy. This will allow the regulatory bodies to optimize the load on budgets of all levels and exercise the personalized control over provision of drugs to the patients;• import dependence and extremely high cost of the original therapy in this sector leads to a decrease in the target indicators of national programs. This problem can be partially solved through technology transfer and production localization within the framework of the relevant industry programs to support the pharmaceutical industry.The implementation of these measures will increase the number of original and reproduced orphan drugs from the nomenclature of the Rare (Orphan) Diseases List published by the Ministry of Health that passed market authorization and circulate on the domestic market, and will improve the supply of drugs to patients, who need them.
REMEDIUM. 2020;(9):4-16
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The market is driven by the public sector
Kalinina N.
Abstract
The public sector has been actively growing over the past two years and is still a growth driver for the entire pharmaceutical market. The unfavourable epidemiological situation and government investments in the sector have given a boost to the Russian pharmaceutical market in the first months of this year. The public sector reached the level of RUB 301 bil. at purchase prices for the period from January to June 2020. According to the estimates of most analytical agencies, the sector will continue to grow in the second half of the year, though its growth will slow down slightly.
REMEDIUM. 2020;(9):18-20
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Public procurement during coronavirus pandemic. Review of tender purchases of J05 Direct-acting antivirals under FZ-44 and FZ-223
Kalinina N.
Abstract
Today, the epidemiological situation and the socio-economic crisis are bringing their own adjustments to our plans. Due to the introduction of a high alert regime related to the coronavirus pandemic, the authorities have introduced the temporary new rules for public procurement. The spread of COVID-19 was recognized as a circumstance of insuperable force (force majeure), inspections were cancelled, and the complaints were handled in the remote mode. In this regard, one more Government Decree No. 647 of May 08, 2020 entered into force on May 10, which defined new cases and the procedure for purchasing from a single supplier until the end of 2020. The Cabinet of Ministers adjusted the rules for calculating the time limits for purchases on non-working days under the same document. However, due to the coronavirus, single supplier tenders were not allowed for all goods, but only for those used to prevent or eliminate the consequences of the spread of coronavirus infection.
REMEDIUM. 2020;(9):21-22
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Trend in global pharmaceutical market: COVID
Prozherina Y.
Abstract
These days the impact of COVID-19 on the pharmaceutical market is becoming increasingly clear. The results of studies show similar trends in different countries against the backdrop of a pandemic that suddenly hit the world. It is obvious that currently COVID-19 has already had an unprecedented impact on the world [1].
REMEDIUM. 2020;(9):23-24
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Lyudmila Alekseeva: «Intensivnaya bol' - eto faktor progressirovaniyaosteoartrita, poetomu ee nuzhno obyazatel'no umen'shat'»
Article E.
Abstract
Заболевания суставов занимают одно из ведущих мест в структуре забо- леваемости населения России. О важности проблемы остеоартрита и современных подходах к его лечению мы попросили рассказать Людмилу АЛЕКСЕЕВУ, заведующую отделом метаболических заболеваний суставов с центром профилактики остеопороза ФГБНУ НИИР им. В.А. Насоновой, д.м.н., профессора.
REMEDIUM. 2020;(9):25-27
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Symptomatic Slow-Acting Drugs (SYSADOA) is the new reality in the treatment of osteoarthritis
Prozherina Y.
Abstract
Osteoarthritis (OA) is the most common chronic progressive joint disease. Over the last years, it has been evidenced that OA is associated with an increased risk of death, which may be explained by low-intensity chronic inflammation underlying its pathogenesis, long-term pain syndrome, and high comorbidity. Considering the above, the FDA classified OA as a serious disease that requires more careful monitoring of patients and the earliest possible prescription of effective therapy in August 2018 [1].
REMEDIUM. 2020;(9):28-30
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Phosphogliv® URSO: a comprehensive approach to the treatment of biliary pathology
Shirokova I.
Abstract
Biliary diseases are the most important medical and social problem associated with a high prevalence among working age population and a significant decrease in patients’ quality of life.Modern therapy methods, including the latest advances in medical science, have sustained significant progress in the treatment of biliary pathology. The design and introduction into clinical practice of the original drug Phosphogliv URSO has become an important step in making progress in this direction.
REMEDIUM. 2020;(9):32-34
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Elena Artamonova: «Primenenie ingibitorov CDK4/6 v kombinatsiis gormonoterapiey pozvolilo dvukratno uvelichit' prodolzhitel'nost' zhizni patsientok s HR+/HER2-mRMZh»
Article E.
Abstract
По инициативе ВОЗ октябрь объявлен месяцем борьбы с раком молочной железы (РМЖ), а 15 октября - Международным днем борьбы с этим тяжелым заболеванием. В 2020 г. к данному событию приковано особое внимание, поскольку оно состоится на фоне охватившей весь мир пандемии COVID-19, существенно осложнившей жизнь онкологических пациентов.
REMEDIUM. 2020;(9):36-38
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A breakthrough in the treatment of chronic lymphocytic leukemia
Prozherina Y., Shirokova I.
Abstract
Chronic lymphocytic leukemia (CLL) is the most common type of leukemia in adults. Its prevalence is expected to increase alongside rising overall survival rates in patients with CLL achieved due to advances in therapy [1]. B-cell receptor signalling through Bruton’s tyrosine kinase (BTK) is one of the main pathways for the development of CLL. Acalabrutinib, the second-generation VTK inhibitor, has been made available recently to Russian patients, which presence in the market can improve the prognosis for such patients.
REMEDIUM. 2020;(9):39-42
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Natal'ya Nenasheva: «Intranazal'nye kortikosteroidy - gruppa preparatov, kotoraya naibolee effektivno vliyaet na vospalenie pri allergicheskom rinite i kontroliruet ego»
Article E.
Abstract
Более 500 млн человек в мире, включая россиян, страдают аллергическим ринитом. Зачастую такие пациенты не обращаются к врачу и занимаются самолечением. О природе заболевания, рисках, связанных с несвоевременным получением адекватной терапии, и современных подходах к лечению аллергического ринита мы решили поговорить с заведующей кафедрой аллергологии и иммунологии ФГБОУ ДПО РМАНПО Минздрава России, профессором, д.м.н. Н.М. НЕНАШЕВОЙ.
REMEDIUM. 2020;(9):43-45
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Bronchial asthma: fundamental changes in the new GINA guidelines(2019)
Vodovozov A.
Abstract
The new guidelines of the Global Initiative for Asthma (GINA) has inspired a heated discussion among experts. The next version was published in 2018, but its revision appeared as early as in 2019. This is primarily due to the revision of the attitude towards short-acting beta-2-agonists, however, the approaches have changed significantly at other stages of bronchial asthma treatment as well, especially at the early stages. The emphasis has been placed on low-dose inhaled corticosteroids, as they have accumulated an evidence base at an adequate quality level. In fact, the 2019 GINA proposals are reduced to discontinuation of the common clinical practice and switching to fundamentally different approaches to the management of bronchial asthma, especially its mild form.
REMEDIUM. 2020;(9):46-50
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Review of pharmacy sales of plasters and self-adhesive dressings
Nechaeva Y.
Abstract
Plasters are essential items for any medicine cabinet at home. The plasters are currently used not only in the treatment of wounds and attachment of bandages or catheters, but also have a therapeutic (for example, analgesic, venotonic, anti-edema action, etc.) or cosmetic effect (anti-cellulite, anti-wrinkle, anti-under-eye circles effects, etc.). In addition, the transdermal route of drug administration is gaining popularity.
REMEDIUM. 2020;(9):51-53
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Study of main factors that lead pharmaceutical workers to change their jobs
Dolova M.A., Yagudina R.I., Gavrilina N.I.
Abstract
Currently, the increase in the efficiency of pharmacy organizations is due to the efficiency of team management. Each pharmacy organization strives to strengthen the workforce and monitors staff turnover rates, because this can affect the economic results of the organization. The most effective tool for preventing the layoff of staff turnover. This article presents the results of a sociological study of the factors that lead pharmaceutical workers to change jobs. The objects of the study were pharmaceutical workers of pharmaceutical organizations of various organizational and legal forms in Moscow. The methodological basis of the research was formed by general theoretical methods of information
REMEDIUM. 2020;(9):54-57
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3D printing in pharmacy
Prozherina Y.
Abstract
3D printing of drugs is an innovative and cost-effective technology, which is a major step towards personalized medicine. This technology can be used for the development of controlled-release drugs; fixed-dose combination drugs, as well as for the creation of orodispersible dosage forms. The global 3D drug market is still largely at the research stage, but its rapid growth is expected in the coming decade [1].
REMEDIUM. 2020;(9):58-60
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Investment activity of pharmaceutical enterprises: 2019
Romanova S.
Abstract
The investment activities of pharmaceutical enterprises were analysed using the data from the state statistical reporting form No. P-2 “Information on investments to non-financial assets” (quarterly).
REMEDIUM. 2020;(9):61-65
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Ne vse strany EAES gotovy povtorit' rossiyskiy eksperiment po markirovke lekarstv
Kuminova E.
Abstract
Дистрибуция в России даже при полной готовности к работе в системе маркировки лекарств предпочитает иметь дело с немаркированной продукцией, потому что на работу по старинке уходит вдвое меньше времени.
REMEDIUM. 2020;(9):66-66
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Proizvodstvo meditsinskoy produktsii za pervoe polugodie 2020 goda
Article E.
Abstract
По данным Росстата, индекс физического объема за первое полугодие 2020 г. по крупным, средним и малым организациям по отношению к соответствующему периоду предыдущего года по кодам ОКВЭД2 составил: 21.1 «Производство фармацевтических субстанций» - 161,2%. 21.2 «Производство лекарственных препаратов и материалов, применяемых в медицинских целях» - 115,8%. 32.5 «Производство медицинских инструментов и оборудования» - 122,0%. 26.6 «Производство облучающего и электротерапевтического оборудования, применяемого в медицинских целях» - 173,3%.
REMEDIUM. 2020;(9):67-72
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