No 12 (2019)

Full Issue

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Articles
Important • interesting • useful
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Abstract
REMEDIUM. 2019;(12):4
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Advertising of prescription drugs: when you can’t have everything and even more
Borzova M.
Abstract
Advertising  of prescription drugs  is regulated  by general  and special  provisions  of the Federal  Law No. 38-FZ “On Advertising” dated March  13, 2006.  However,  the procedure  for application  of the relevant  rules  is disclosed  in law enforcement  practice: decisions  of the antimonopoly  authority  and courts.Law enforcement  practices  for advertising  of prescription drugs contain a separate layer of regulatory  interpretations and require special analysis and evaluation when strategically planning and strategizing to promote such drugs.In practice,  one can find answers to a number of complex and ambiguous questions. These questions include the formation of fair marketing policies of pharmacies  in relation to the circulation of prescription drugs; limitations  that may be applicable to scientific and practical  articles  reporting  information  about diseases and existing  drug options; creation  and content  of websites that may contain  information  related to the description of prescription drug properties;  procedure  for comparing  prescription drugs with each other according to the mechanism  of action and other criteria;  use of certain words and expressions in advertising  materials that are distributed  at professional  medical  events and published  in specialized  printed  publications.  In addition,  the analysis  of solutions from law enforcement practice reveals approaches to assessing the reliability of information contained in advertisements, as well as methods to identify relevant violations of the law and the procedure  for assessing  evidence by the enforcer.All these issues  are covered  in detail  in this  article  based on an analysis  of case  proceedings regarding  the unfair  advertising of prescription drugs.  The  article  provides  the  most  complete  set  of solutions  that  are  important  from  the  point  of view  of practitioners.
REMEDIUM. 2019;(12):6-14
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The silence of the archive: creation of «Soviet penicillin»
Sherstneva E.V.
Abstract
The history of the creation of penicillin in the USSR has not yet been studied. During  the Soviet era, this theme became a source of literary activity, it served the purpose of propagating  the advantages of socialist  science, and therefore was significantly distorted. Granting  access  to the previously  classified  documents  of the State Archive  of the Russian  Federation  (ST RF) to the researchers made it possible to revise the version of history  proposed by the Soviet historiography.
REMEDIUM. 2019;(12):16-20
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If you can’t breathe through your nose
Kalinina N.
Abstract
According to figures  provided by the  Ministry  of Health, the  autumn-winter period is characterized  by the  prevalence  of outbreaks of ARVI and influenza. In case of ARVI of no influenza  etiology,  the disease  develops  gradually, it is most often accompanied by cough, and begins  with usual fatigue and rhinitis  (runny nose), which makes nasal breathing difficult  and worsens  the  patient’s condition.  That is  why the  treatment  of rhinitis  is  an important  component  of the  comprehensive treatment  of ARVI and influenza.
REMEDIUM. 2019;(12):21-22
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Contract manufacturing and R&D: emerging trends for the global pharmaceutical market
Prozherina Y.
Abstract
In recent years, health expenditures  have been gradually increasing. The expenditures  under this article in 60 countries  are expected to grow at an average of 5.4 percent during the period from 2018 to 2024 [1]. The key trends include the focus on R&D development with a reasonable realignment of budget and the increasing contract manufacturing practice.
REMEDIUM. 2019;(12):24-26
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Budget segment of the PD market in Russia: results for 9 months of 2019
Prozherina Y.
Abstract
The budget segment of the market plays a key role in the system of medical supply of hospital institutions and in the implementation of PD within the framework of preferential drug provision (PDP) and regional preferential provision (RPP) programmes. The key trends of this segment for 9 months of 2019 are considered in this review.
REMEDIUM. 2019;(12):27-29
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«According to careful estimates, approximately 35 mil. people currently suffer from Alzheimer’s disease and Parkinson’s disease worldwide». Interview with Sergey Illarioshkin
Shirokova I.
Abstract
Неуклонное старение населения – глобальный вызов, стоящий перед системами здравоохранения многих  стран  мира из-за возросшего  риска развития многих  тяжелых  нейродегенеративных заболеваний,  включая болезнь Альцгеймера (БА) и болезнь  Паркинсона (БП).Насколько опасны эти расстройства,  как совершенствуется их диагностика и на чем строится  современная  терапия? Эти и другие вопросы мы задали Сергею ИЛЛАРИОШКИНУ, заместителю директора по научной работе, руководителю отдела  исследований мозга ФГБНУ «Научный центр неврологии», члену-корреспонденту РАН, профессору,  д.м.н.
REMEDIUM. 2019;(12):30-33
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Big Data Analytics of EHRs: pathogenic relations of cancer with Ischaemic Heart Disease and Diabetes Mellitus
Kolesnichenko O.Y., Kolesnichenko Y.Y., Pulit V.V., Martynov A.V., Sotnik A.Y., Khaykina I.A., Marochkina E.B., Minushkina L.O., Pimenova K.V., Bugakova A.S., Vasilyeva E.Y., Komarov R.N., Golovanov A.V.
Abstract
The incidences of cancer  in patients with ischaemic  heart disease and diabetes mellitus  (types 1 and 2) were analyzed  according to the electronic health records  (medical  information  system  qMS). For  several  years,  a predominance  of prostate  cancer  and colorectal  cancer  in almost 10 thousand  patients  with ischaemic  heart disease were revealed; in patients  with diabetes mellitus type 1 lung cancer  was prevailed; and in patients with diabetes mellitus type 2 colorectal  cancer  and lung cancer  were prevailed. Prostate  cancer   and  ischaemic   heart  disease  are  associated  with  a  general  imbalance  within  estrogen  receptors   ERα,  ERβ, gpER,  which  occurs  in old age with  reproductive function  fading. Hyperglycemia in diabetes  mellitus  causes  a blocking  of the parathyroid  hormone-related protein  signaling  pathway, which  creates  a favorable environment  for carcinogenesis in the lungs. Hyperinsulinemia, as a result of insulin resistance  in diabetes mellitus and in metabolic syndrome  accompanying ischaemic  heart disease, triggers  signaling  pathways,  including mTOR,  which  contribute  to the carcinogenesis in the large intestine  epithelium. Three  different  patient samples showed the different  pictures  of tumor localization, and for each of the identified  predominant cancer  localization common signaling  pathways with a concomitant metabolic disease can be distinguished.
REMEDIUM. 2019;(12):36-43
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International approaches to the formation of the quality system of the pharmaceutical inspectorate
Nikolenko N.S., Beregovykh V.V.
Abstract
In most countries  pharmaceutical market is regulated by the state in order to provide the population  with high-quality, safe and effective medicines.Pharmaceutical inspection  for compliance  with the requirements  of any good practice  in the field of drug circulation is one of the main components  of national regulatory  system.Modern organization of pharmaceutical inspectorate involves presence of a quality system. Development and operation of such a system is not an easy task.In the review, the authors  analyzed  main international  approaches  and directions of normative  regulation  of the quality system for pharmaceutical inspectorate,  examined  the requirements  of ISO  9000  standard  for creating  quality management systems  in organizations, and proposed a model of the quality system of pharmaceutical inspectorate based on the process  approach.
REMEDIUM. 2019;(12):44-53
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Investment activity and financial results of medical enterprises: intermediate results for 2019
Romanova S.
Abstract
The analysis of investment activity and financial results  of enterprises producing irradiation and electrotherapy equipment was carried out according to the data of state statistical  reports of Form No. P-2 «Information on investments in non-financial assets» and Form No. P-3 «Information on financial condition of the organization».Investments in  fixed  capital  of enterprises of various  economy  sectors  by type  of activity  with  the  OKVED2  code  26.6: «Manufacture of irradiation and electrotherapeutic equipment used in medicine» in the first half of 2019 in Russia amounted to 525.243 million rubles, which is 2.63 times higher than the previous year. At the same time the share of medical industry enterprises with the OKVED2 code 26.6 in the total volume of investments was at the level of 126.22%, which testifies to the fact that in the reporting period the trend for the redistribution  of investments by enterprises of the industry in favor of the increase in investments in other (non-core) types of activities  was observed.The financial state is the most important characteristic  of the economic activity of the industry’s enterprises, which determines its economic attractiveness. As a result of the economic activity in the first half of 2019 the enterprises of the industry of medical products with the OKVED2 code 26.6: «Manufacture of irradiation and electrotherapeutic equipment used in medicine» received revenues from the sale of products, works and services in the amount of 12.203 billion rubles, which is 1.14 times higher than the previous year. In the first half of 2019, as compared to the previous year, the industry’s enterprises increased their sales profit 1.26 times and profit before tax 1.23 times, while the sales profitability increased by 1.31 points accordingly.
REMEDIUM. 2019;(12):56-62
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Industry manufacturers rating by sales profit and pre-tax profit in 2017
Romanova S.
Abstract
The medical device manufacturers rating by pre-tax profit and sales profit was prepared using the state accounting reports of 60 leading manufacturers in the industry. Only profitable medical device manufacturers were included in the rating.The pre-tax profit and sales profit of the medical device manufacturers  included in the 2017 rating increased  by 9.15% and 9.55% compared to the previous year and amounted to RUB 4.502 bil. and RUB 5.605 bil.In addition  to  pre-tax  profit  and sales  profit  indicators  in  absolute  terms,  relative  indicators  were  used  to  carry out comprehensive assessment of the  industry  manufacturers  performance.  The relative  indicators  included  such  criteria  as pre-tax profit and sales profit gains as compared to the previous year. The manufacturers  rating was determined  using one of the mathematical methods, which is called the sum of rankings.
REMEDIUM. 2019;(12):63-68
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Juridical review: August – October 2019
Borzova M., Arushanova A.
Abstract
The review provides an analysis of litigation  practice relating to the manufacture and circulation of medical devices to help industry specialists  avoid mistakes in solving problems of a similar nature.
REMEDIUM. 2019;(12):69-73
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Medical device manufacturing in November
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Abstract
По данным Росстата.
REMEDIUM. 2019;(12):76
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Russia: import of FPPs at аugust-end 2019
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Abstract
Согласно данным ИАС «Клифар: Импорт-Экспорт», в августе 2019 г. в Россию было импортировано ГЛС на сумму почти 950 млн долл., что на 31% выше показателя за август 2018 г., но на 8% ниже значения за июль 2019 г. (рис.).
REMEDIUM. 2019;(12):77-78
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Russia: export of FPPs at аugust-end 2019
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Abstract
Согласно данным ИАС «Клифар: Импорт-Экспорт», в августе 2019 г. из России было экспортировано ГЛС на сумму более 32 млн долл., что на 28% выше показателя за август 2018 г. и на 2% выше значения за июль 2019 г. (рис.).
REMEDIUM. 2019;(12):79-80
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Sherstneva Elena Vladimirovna
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