No 7-8 (2020)

Full Issue

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Articles
V Rossii vvedena obyazatel'naya markirovka lekarstvennykh sredstv
Article E.
Abstract
С 1 июля в России стала обязательной цифровая маркиров- ка лекарственных препаратов, данные о движении которых на всех этапах должны вноситься в систему маркировки. Проверить легальность конкретной упаковки теперь может любой желающий с помощью приложения «Честный знак» посредством сканирования кода Data Matrix, нанесенногона упаковку.
REMEDIUM. 2020;(7-8):4-5
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Analysis of current issues for development of pharmaceutical products export in the russian federation: the case of biotechnology enterprise
Trukhin V.P., Narkevich I.A., Nacharova E.P., Basakina I.I., Poliakova I.N.
Abstract
Current mechanisms for development of pharmaceutical products export in the Russian Federation are analyzed. Key vectors for solving problem issues in the processes of pre-qualification of medicines and inspection of compliance with GMP and GCP requirements by foreign regulators have been established: the case of biotechnology enterprise.
REMEDIUM. 2020;(7-8):6-11
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Pharmacy retail in the age of pandemic
Kalinina N.
Abstract
The commercial sector of the Russian pharmaceutical market at the first half year-end 2020. The coronavirus infection epidemic, surely, has become one of the central themes of the beginning of the year. In the first half of 2020, the commercial sector of the Russian pharmaceutical market grew by 5% in terms of roubles as compared to the same period last year, but in dollar terms, the growth rates were much lower (-0.5%).
REMEDIUM. 2020;(7-8):12-14
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Reyting aptechnykh setey Rossiipo itogam 1-go polugodiya 2020 goda
Bespalov N., Rasshchupkin P.
Abstract
Острая фаза эпидемии COVID-19 в России в целом миновала. Вообще, коронавирусные реалии даже уже начали благополучно забываться. Нельзя сказать, что для фармрынка в целом и для фармретейла в частности «болезнь» прошла совсем без последствий, тем более что в отрасли достаточно «сопутствующих заболеваний». По результатам работы во II квартале 2020 г. рынок ожидаемо ушел в минус, потребители «переваривают» сделанные во время ажиотажа запасы, макроэкономика тоже оставляет желать лучшего.
REMEDIUM. 2020;(7-8):15-15
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Beyond the Future
Prozherina Y.
Abstract
Artificial Intelligence (AI) is increasingly making inroads in our life and becomes an integral part of modern business. In accordance with the Decree of the President of the Russian Federation “On the Development of Artificial Intelligence in the Russian Federation”, the National Strategy for the Development of Artificial Intelligence for the period until 2030 entered into force in October 2019. This article discusses the growing role of this technology in the transformation of the Russian pharmaceutical sector.
REMEDIUM. 2020;(7-8):16-18
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Hepatitis C treatment breakthroughs
Shirokova I., Kalinina N.
Abstract
In July, World Hepatitis Day celebrated its 13 th year - a global public health problem that demands focused attention. Among these pathologies, hepatitis C holds a unique position as a disease with dangerous consequences. No vaccines have ever been developed for prevention against hepatitis C. At the same time, the treatment of this disease showed a meaningful progress, as well as new optimal solutions have been shown to significantly improve the prognosis in patients.
REMEDIUM. 2020;(7-8):19-22
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Changing breast cancer prognosis
Prozherina Y., Shirokova I.
Abstract
Breast cancer (BC) is the leading oncologic pathology in the female population of Russia, which accounts for 21.1% of all malignant neoplasms in patients [1]. Despite great progress in diagnosis of the disease, detection of breast cancer in late stages is one of the significant problems. In this regard, the improvement of approaches to the treatment of breast cancer, including its metastatic forms, is a highly topical problem of modern medicine.
REMEDIUM. 2020;(7-8):24-28
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The role of NSAIDs in the treatment of OA: new data
Vodovozov A.
Abstract
Modern therapy for osteoarthritis of any localization follows the principle on integrating patients’ concerns as much as possible, including thorough building of balance of benefits confirmed in strict accordance with the principles of evidence-based medicine, and potential harm due to unwanted side effects of the drugs used. In this case, NSAIDs gained a rightful place of drugs of choice, but the emphasis was placed on their systemic use, on oral forms for a long time. The new guidelines from the American College of Rheumatology (ACR) and the Osteoarthritis Research Society International (OARSI) are shifting the center of balance towards topical forms, focusing on current evidence of their effectiveness and safety. At the same time, it is recommended to refuse some previously used agents, for example, chondroprotectors.
REMEDIUM. 2020;(7-8):29-32
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Analysis of the market of products based on plant-based raw materials used in urology
Safonova N.V., Trofimova E.O.
Abstract
Introduction. The wide prevalence of diseases of the genitourinary system determines the need to use a variety of tools for their treatment and prevention, including plant-based raw materials.The purpose of the study is to determine the main characteristics and trends in the development of the market of urological medicines and dietary supplements plant-based on raw materials, as well as the competitive positions of foreign and domestic manufacturers in this segment. Research methods. The study was conducted using the DSM Group pharmacy sales database, official sources of information about the registration of medicines and dietary supplements, and clinical recommendations.Results. Pharmacy sales of herbal medicines and dietary supplements used in urology in 2018 amounted to 32 million packages worth14,4 billion rubles in retail prices. Drugs accounts for 78,5% of the market structure in terms of value and 82,8% - in kind. More than half of the total market is occupied by funds used for infectious and inflammatory diseases, where the share of drugs accounts for more than 90%. Russian companies account for 9% of the drugs segment and 64,2% of dietary supplements in value terms.Conclusion. Russian manufacturers occupy relatively weak competitive positions in relation to leading foreign companies due to the use of outdated forms of production, as well as focusing on the dietary supplements market.
REMEDIUM. 2020;(7-8):34-41
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JAK inhibitors in rheumatoid arthritis: new opportunities and perspectives
Shirokova I.
Abstract
Rheumatoid arthritis (RA) is a pressing medical and social problem, on which researchers around the world are working. One of the solutions that could significantly improve the prognosis of patients’ treatment and their quality of life was discussed within the framework of the VI Rheumatology Summit held online on June 26-27 by the Association of Rheumatologists of Russia with the participation of leading Russian and foreign experts. The method is based on the use of upadacitinib, an innovative drug of JAK inhibitors class.
REMEDIUM. 2020;(7-8):42-46
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Aleksandr TIKhOMIROV: «Nuzhno nachinat' lechenie kak mozhno ran'she, chtoby potom ne «dogonyat'» tyazheluyu voskhodyashchuyu infektsiyu»
Article E.
Abstract
Воспалительные заболевания органов малого таза (ВЗОМТ) лидируют в структуре гинекологической заболеваемости, более того, их распространен- ность продолжает расти1.Насколько опасны эти заболевания, кто находится в группе риска и каковы современные подходы к профилактике и лечению ВЗОМТ, мы попросили рассказать Александра ТИХОМИРОВА, д.м.н., профессора кафедры«Акушерство и гинекология» МГМСУ им. А.И. Евдокимова.
REMEDIUM. 2020;(7-8):47-49
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Immunotherapy on guard for women’s health
Prozherina Y.
Abstract
Pelvic inflammatory diseases (PID) is a important clinical and public health issue, which relevance is caused by high prevalence of this group of infections and serious consequences for women, including the loss of reproductive functions. The prospects for the demographic development of Russia largely depend on the solution of this issue.
REMEDIUM. 2020;(7-8):50-53
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The electronic common technical documentformat as the basis for a single pharmaceutical market of the Eurasian Economic Union
Taube А.А., Levashova A.Y.
Abstract
Background. Due to ratification of the Decision of the EAC Commission on the circulation of medicinal products, a common EAEU pharmaceutical market will be formed, and registration dossiers will be accepted in electronic form of eCTD in XML format starting from January 1, 2021. It is related to the fact that the EAEU member states will exchange information on medicinal products and their results within the framework of an information integrated system. An application for marketing authorization is now submitted in electronic form in PDF format in accordance with the legislation of the Russian Federation. The XML format has been used in the EU since 2003, but not in the Russian Federation. To continue circulation of authorized medicinal products on the territory of the EAEU, it is necessary to bring the registration dossier in accordance with the requirements of the EAEU by December 31, 2025. Beginning on January 01, 2021, applications for marketing authorization of medicinal products will be only accepted under the legislation of the EAEU. In this regard, Russian enterprises - marketing authorization holders have been tasked with converting all registration dossiers to XTML files. The study is aimed to analyse the market for proposals for installation of software to convert documents to the required format and development recommendations for enterprises - marketing authorization (MA) holders - for making the necessary decisions. Commercial proposals of three software companies were studied and recommendations were developed for enterprises - MA holders within the framework of a situation analysis.Purpose of the study. To analyse the market for proposals for installation of software to convert documents to the required format and development recommendations for enterprises - marketing authorization (MA) holders for making the necessary decisions.Conclusion. The study identified factors that have an impact on the decision-making of the heads of pharmaceutical organizations regarding the choice of proposals for installation of software to convert registration dossier documents to the required format according to the rules of the EAEU. It investigated the consequences of various decisions. Recommendations have been developed for companies - MA holders for submitting an electronic DMF in accordance with the EAEU rules.
REMEDIUM. 2020;(7-8):54-59
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Marketing is dead. Focus on the consumer
Prozherina Y.
Abstract
The coronavirus pandemic has affected each and every sphere of activity. It demanded a quick response and emergency measures, which not only ensure epidemic safety and public health protection, but also preserve business viability. All of a sudden, the rules of the market game underwent a 180-degree turn, and year-old marketing facilities became ineffective. This applies in full to the pharmaceutical industry, which seemed affected to a lesser degree.
REMEDIUM. 2020;(7-8):60-61
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Farma vo vremya pandemii. Ekspertnoe mnenie
Article E.
Abstract
Период самоизоляции и карантина стал вызовом для фармацевтической индустрии. Взрывной спрос на одни категории аптечных товаров при практически полном отказе от других, паника и страх, осторожность и надежда на скорейшую стабилизацию ситуации - с этими проблемами в большей или меньшей степени столкнулись аптечные организации и фармацевтические компании многих стран. Личными впечатлениями о непростой ситуации, сложив- шейся во время пандемии COVID-19, с нами поделились эксперты из России и нескольких стран Европы.
REMEDIUM. 2020;(7-8):62-63
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Research into the causes of conflicts in a pharmacy organization
Safronova Z.S.
Abstract
Background. The operating conditions of a contemporary pharmacy organization with due account for economic changes and information technology development raised the need for qualitative studies of conflicts, systematization and generalization of cumulative academic and research experience. A theoretical analysis of research articles showed that most conflict studies are based on the analysis of books of comments and suggestions, questionnaires and other types of survey, which does not rule out the subjective nature of data obtained. The number of studies and the quality of conclusions highlight the need to develop new methodological approaches.Objective: To determine the main causes of conflicts in the pharmacy organizations.Methodology and research results. Subjects: residency students working at pharmacy organizations. Methods: case analysis, role-playing case scenarios, expert evaluations, observation. A total of 93 conflict cases were drawn up and analysed. 4 groups of conflicts and conflict causes were identified. The researchers implemented 16 role-playing case scenarios and determined the level of intensity of pharmacists’ experience of conflicts. They identified tolerance for conflicts with patients and pharmacists’ vulnerability in conflicts with the manager. The remarkable thing is that the head of the pharmacy organization plays a key role in the conflicts.Conclusions. The personality of the leader, insufficient attention to conflict prevention methods and low conflictological competence of pharmacy workers are the main causes of conflicts. The need for system conflict researches has been raised. The vectors of further research have been stated.
REMEDIUM. 2020;(7-8):64-69
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Prevalence and effectiveness of different types of advertising and PR tools among community pharmacies in Saudi Arabia
Ben Y..., Pyatigorskaya N.V.
Abstract
This research aims to identify the most effective and prevalent type of advertising and PR-tool used by pharmaceutical companies at com- munity pharmacies. A cross-sectional study design was carried out using the non-repeated random sampling technique in the city of Riyadh (Kingdom of Saudi Arabia). Standardized questionnaires were administered by means of face-to-face interviews or via online software Sphinx. The relative importance of prevalence and the mean evaluation of effectiveness were determined for all studied marketing tools in the differ- ent groups of respondents (pharmaceutical sales representatives, community pharmacists, consumers, and the entire sample). Inter-individual differences in prevalence and evaluation of effectiveness were assessed by computing the coefficient of variation, whereas inter-group differ- ences were determined by one-way analysis of variance (ANOVA) with the Scheffé test as a post-hoc test.Research findings showed that, according to all respondents and to the respondents of certain groups, the most prevalent PR tool in pharma- cies was gifts with company’s logo. The same tool also was rated with the highest mean evaluation as the most effective one in the group of consumers, pharmacists, and all respondents. The most prevalent type of advertising used in community pharmacies was outdoor print adver- tising, and as the most effective was named video indoor advertising, according to the general opinion of all respondents.In conclusion, the results of the present research enable an understanding of which advertising types and PR-tools are commonly used at community pharmacies and which ones are the most effective, mostly influencing consumers’ purchasing decisions.
REMEDIUM. 2020;(7-8):70-78
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Analysis of foreign experience in training personnelfor the pharmaceutical industry in the European Union
Budenkova E.A., Litvinova T.M.
Abstract
The article is concerned with the system of higher pharmaceutical education in the European Union countries. The analysis has allowed to establish that there is no single curriculum in the training system of pharmaceutical specialists; the curriculum content also has significant differences. For historical reasons, there have been three groups of countries characterized by a different approach to pharmaceutical education: the first group includes countries of Central and Eastern Europe and Scandinavia, where the chemical sciences lie at the root of training of pharmaceutical specialists; the second group is represented by the Franco-Italian-Spanish school, where the priority is given to biomedical disciplines; the third group includes countries, where training is carried out according to the traditions of the English pharmaceutical school. This determines the contradictions in the world practice of training of pharmaceutical personnel. There are significant discrepancies in terms, curricula, academic disciplines, degrees. At the present stage, there have not yet been created any transnational standards for the training of pharmacists, which significantly complicates the training, recognition of diplomas and qualifications at the interstate level.
REMEDIUM. 2020;(7-8):79-83
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Inhaled surfactant in patients with COVID-19 who took high-flow oxygen therapy: the results of a retrospective analysis
Averyanov A.V., Klypa T.V., Balionis O.I., Bychinin M.V., Chernyak A.V., Troitskiy A.V.
Abstract
This article presents a retrospective analysis of clinical, laboratory data, and outcomes in patients with the diagnosis of SARS-CoV-2 infection with severe bilateral pneumonia complicated by acute respiratory distress syndrome.We analyzed the case histories of the patients who received high-flow nasal cannula oxygen therapy at the intensive care unit of the FGBU FNKC FMBA of Russia. 20 patients received standard therapy. 19 patients were additionally prescribed inhaled Surfactant BL 75mg nebulized twice daily for 5 days.This retrospective analysis shows that the administration of an inhaled surfactant before initiating mechanical ventilation can inhibit theprogression of respiratory failure, prevent mechanical ventilation, and improve survival.
REMEDIUM. 2020;(7-8):84-88
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Financial results of pharmaceutical industry: 2019
Romanova S.
Abstract
Financial status is the most important characteristic of the economic activity of enterprises in the industry, which determines its economic attractiveness. Let us consider a set of indicators reflecting the availability, placement and use of financial resources of enterprises in the industry.Analysis of financial status of pharmaceutical companies is made using State Statistical Reporting Form No. P-3 Information on CompanyFinancial Status.
REMEDIUM. 2020;(7-8):89-94
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Rezervy polnogo tsikla
Kuminova E.
Abstract
Год начался с усиления участия государства в лекарственном обеспечении онкологических и орфанных пациентов, в результате чего в I квартале 2020 г. заметно увеличилась доля государства на фармрынке. Одновременно с этим пандемия коронавирусной инфекции перестала быть чем-то внешним для России и начала кардинально влиять на жизнь в стране. Сначала ее влияние на фарму казалось положительным: в марте, накануне введения режима самоизоляции, произошел резкий скачок спроса на лекарственные препараты. Но вскоре на фоне введенных ограничений упала покупательная способность населения, а за ней и динамика продаж. Однако снижение покупательной способности населения оказалось не главным фактором риска для производителей лекарств в условиях коронавирусной пандемии. Какие трансформации ждут российскую фарму в стремительно меняющейся глобальной экономической реальности, эксперты отрасли обсудили в ходе онлайн-форума «Российский фармацевтический сектор в условиях мировой пандемии» 9 июня.
REMEDIUM. 2020;(7-8):96-98
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TOP-pozitsii. Pokazateli vedushchikh mirovykh i otechestvennykh proizvoditeley i distrib'yuterov
Article E.
Abstract
Производство медицинской продукции за I квартал 2020 года Импорт ГЛС в Россию по итогам апреля 2020 года Экспорт ГЛС из России по итогам апреля 2020 года
REMEDIUM. 2020;(7-8):100-104
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