REMEDIUM

The biopharmaceutical industry is a major source of innovation and a driver of development of both the global pharmaceutical market and the different national markets, including the Russian one. The development of the Russian market of biotech drugs was facilitated by the expansion of state drug supply programs and the formation of the Russian pharmaceutical industry. The aim of the study was to assess the nomenclature, volumes and values, dynamics and structure of the Russian BD market in 2013–2023. BDs were identified as medicinal products obtained using recombinant DNA technology. Materials and methods. The study was based on the state registration, patent and scientific information, as well as sales data of DSM Group. Market segmentation was carried out considering the allocated groups of BDs, as well as ATC classification system. Results and discussion. In 2023 in Russia the sales value of BD related to 168 INNs amounted to RUB 288.4 billion in wholesale prices. In the sales structure, the main BD groups were mAbs and hormones. The leading therapeutic classes were antineoplastic agents and immunosuppressants, while orphan drugs accounted for 27.3% of the sales. Since 2013, the compound annual growth rates of BD sales in Russia have exceeded the global figures. BD's share in the Russian pharmaceutical market was significantly smaller than in the global market. Market share of biosimilars mostly represented by domestic products was high. The share of Russian-made drugs mainly provided by a limited list of companies increased to 30.8% by 2023 due to the development of biosimilars and original drugs. Conclusion. The BD segment has been remained as the most actively developing part of the Russian pharmaceutical market, where are concentrated the activities of the leading Russian companies aimed at the development of biosimilars and original drugs.

Introduction. Various industries, including pharmaceuticals, are actively participating in the growing trend towards sustainable development. One of the most important areas is reducing the amount of non-biodegradable plastic. However, in the pharmaceutical industry, which performs an important social function, polymeric materials are used to produce packaging that ensures the proper quality of drugs. Therefore, the implementation of approaches that meet the principles of sustainability is not always appropriate and environmentally valuable. The aim of the work is to develop basic approaches to the implementation and use of polymer packaging that meets the principles of sustainable development in the pharmaceutical industry. Materials and methods. The methodological basis of the scientific study was a set of research methods: bibliographic, analytical, conceptual, structural-functional and comparative analysis. The sources of information were analyzed, including professional literature, scientific articles, methodological recommendations, regulatory legal acts, as well as explanations to them. Results. The main problems and limitations preventing the use of packaging in pharmaceutical practice that fully meets the concept of sustainable development are identified, both at the level of materials used in the production of such packaging and in the case of recycling of used packaging; ways to improve legislation in terms of handling pharmaceutical packaging are proposed; requirements for sustainable packaging for its use in pharmaceutical practice are defined. Conclusion. Optimization of package sizes, reduction of the amount of materials, transition to mono-component packaging, as well as the use of biodegradable polymers seem to be the most realistic of the existing approaches, especially in the case of using sustainable packaging as secondary and group (transport) packaging. Effective recycling of polymeric materials of pharmaceutical packaging, including those generated in households, is associated with a number of difficulties. Implementation is impossible without creating an infrastructure for the separate collection of medical waste. The use of secondary materials in the production of pharmaceutical packaging is impossible, since it contradicts the principles of good manufacturing practice. At the same time, if conditions are formed at the legislative level, it is possible in a number of industries to use medical waste as secondary raw materials.

The use of telemedicine technologies within the framework of a day hospital can be very effective in providing remote online rehabilitation of children who are at home. The process of rehabilitation assistance in these conditions is based on the standard principles of rehabilitation work. The basics of rehabilitation should be considered here: the early start of corrective actions, the prescription of remedies in a complex, reasonable individualization of rehabilitation, compliance with its stages, a clear sequence of activities, a combination of local and general therapeutic effects, the presence of a social component in rehabilitation programs, the use of monitoring to assess the adequacy of health-improving effects and tracking parameters that allow to determine the effectiveness of rehabilitation. The success of rehabilitation is ensured by an interdisciplinary rehabilitation team, which must include an attending physician, nurse and consultant physicians.

Quality of life is one of the most significant indicators of the effectiveness of care for patients with multiple sclerosis. The aim of this work was to summarize the available literature on the characteristics of the main questionnaires used to assess QOL in patients with multiple sclerosis. Materials and methods. The search for relevant literary sources was conducted in the PubMed bibliographic database. The search queries used the keywords: «multiple sclerosis», «questionnaires», «quality of life», and the English-language names of the tests. Publications were selected by title and abstract content. Results. The scientific literature encompasses a wide range of questionnaires for assessing the condition and quality of life of patients with MS. The work considers the main tests. Some of them include a standard block of general questions, for example, SF-36, allowing for comparison between patients with various diseases and healthy subjects. It is noted that the design of questionnaires with the inclusion of general and specialized blocks is very convenient for simultaneously obtaining diverse, comprehensive assessments of the course of MS. In practice, the choice of a specific questionnaire depends on the goals and objectives of its use. Discussion. Some questionnaires are more often used in clinical and epidemiological studies, while others have already been introduced into everyday clinical practice. Before introducing new questionnaires written in foreign languages into the Russian healthcare system, they need to be adapted. Validation of questionnaires in regional healthcare will open up new prospects for their use in regular clinical practice.

Based on a study of the opinions of 9.3 thousand medical workers, an analysis of the intensity and results of the use of digital technologies in the provision of medical care in the Moscow region was carried out. The data obtained allow us to assert that, in general, the digital transformation of the healthcare system in the Moscow region is being carried out successfully. At the same time, the knowledge of medical workers about the capabilities of medical information systems is insufficient; not all the effects expected from the implementation of these systems have been achieved. It is necessary to strengthen educational work among medical workers, especially older age groups, on the use of digital technologies in the organization and provision of medical care, as well as to eliminate duplication of the same doctor’s actions in electronic and paper document flow when preparing medical documentation.

Special attention from the scientific community and health care organizers is required to timely respond to the problem of professional burnout and post-pandemic stress of medical workers by developing and implementing a comprehensive program for the prevention and control of professional burnout, taking into account various aspects of the consequences of the COVID-19 pandemic, which improves the availability and quality of medical care, and as a result — to alleviate the course of post-pandemic stress syndrome, improve the quality of life of medical workers and the level of patient satisfaction with medical care.

The vulnerability of an assessment conducted by another person lies in the varying degree of rigor of the examiner, possibly his lack of competence and likely dependence on others. Ensuring objectivity is achieved by selecting examiners based on informal signs of professional development. Categorization implies an assessment of the qualifications of specialists directly by the members of the qualification commissions. The purpose of the study is to assess the ability of requirements for members of qualification commissions to ensure their unified expert level of qualification and independence. Methods. The expert survey was conducted by correspondence and consisted of one iteration. The expert assessment of the requirements for the members of the qualification commissions was carried out according to 3 parameters: The ability of the requirements to guarantee a single expert level of qualification of the commission members in professional activities (1) and related disciplines (2), as well as the independence of the commission members (3). A ten-point Staple scale was used. For the analysis, the sums of the estimates were calculated, the consistency of the estimates, the normality of the distribution and the differences in expert estimates for two or more criteria were checked. The threshold value of the error level, p, is less than 0.05. Results. Expert estimates are consistent, W = 0.877, p ≤ 0.001. The sum of the assessments of the ability of the requirements to ensure the expert level of qualification of a member of the commission in professional activity is equal to –193, in related disciplines — −199, independence — −299. Expert assessments of the ability of requirements to guarantee independence are lower than to guarantee an expert level in professional and related fields, U = 1372, p ≤ 0.001, for both pairs. The estimates of the first and second parameters do not differ significantly, U = 1964.5, p ≤ 0.915. The ability to guarantee expertise in professional and related fields is better assessed by accreditation requirements than by other requirements, p = 0.001. Conclusions. Most of the requirements imposed on members of qualification commissions do not guarantee their expert level in professional activities and related disciplines, as well as independence from third parties.

The article focuses on the study of modern drug insurance programs and products in Russia, analyzing their development and prospects. The formation of a market economy in Russia in the 1990s was accompanied by the creation of a new legislative framework to regulate various activities, including insurance. Key legislative acts such as Chapter 48 of Part 2 of the Civil Code of the Russian Federation and Law No. 4015-1 «On the Organization of Insurance Business in the Russian Federation» laid the foundation for regulating insurance activities. The introduction of the mandatory health insurance (MHI) and voluntary health insurance (VHI) systems allowed citizens and organizations to receive additional medical services. Today, Russia has a state system for drug provision funded by MHI funds and various budget levels. The state aims to provide preferential categories of citizens with quality pharmaceutical assistance by regulating drug prices and covering the costs of their acquisition. For other citizens, there are commercial drug insurance programs that have developed alongside the VHI system. These programs offer the possibility of compensation for drug expenses, which is especially important in the context of rising pharmaceutical prices. The aim of the research is to analyze and evaluate modern drug insurance programs and products for various categories of citizens, as well as their position and prospects in the insurance services market. The study uses the method of in-depth interviews in the format of a «mystery shopper», as well as an analysis of key informational documents, VHI contracts, and the terms of drug insurance programs. The offerings of major insurance companies such as Sberbank Insurance LLC, Ingosstrakh PJSC, and others were examined. The research results show a variety of insurance product configurations, their main characteristics, and features. Particular attention is given to the digitalization of insurance services, which significantly speeds up the policy issuance and compensation payment process. The article also examines trends and prospects for the development of the drug insurance market in Russia, such as increasing public awareness, expanding the range of insurance products, developing partnerships with medical organizations, and strengthening state regulation. Ways to improve the accessibility of pharmaceutical assistance for various population groups are discussed, as well as potential directions for further development of the drug insurance market.

Marketing research has shown that medicinal products and pharmaceutical substances of plant origin containing flavonoids are presented in the form of 965 and 73 trade names, respectively. It was revealed that the sources of herbal medicines containing flavonoids are 25 families, 49 genera and 74 plant species. About 130 pharmaceutical companies produce herbal medicines, among which the leading position is occupied by domestic manufacturers, mainly located in the Central Federal District. Russian pharmaceutical companies produce 76% of the range of drugs and 59% of pharmaceutical substances of plant origin. In the import structure, the largest share in terms of the number of supplied herbal medicines belongs to companies from Germany and India (19.3% each), and among suppliers of herbal pharmaceutical substances, the contribution of pharmaceutical manufacturers from China (35.7%) should be noted. It has been established that herbal medicines containing flavonoids are available to consumers in 30 different dosage forms.

The article presents the results of a study conducted to identify opportunities for budget savings in healthcare in federal programs. A set of methods was used in the study: bibliographic, analytical and comparative analysis. The IQVIA Database was used as source of information — data on purchases in the «budget segment» in hospitals and for privileged categories of citizens (federal and regional benefits). Based on an analysis of a sample of 11 INNs with signs of secondary patents, it is shown that entering the generics market (in the absence of secondary patents) will save the budget 82.5 billion rubles over three years. This corresponds to an average annual budget savings of 27.5 billion rubles, which is equivalent to financing the federal project «Combating diabetes mellitus» for the period from 2024 to 2026.

Primary health care is a basic element of the healthcare system. The current socio-economic situation makes the issue of stable and progressive development of the primary link even more acute. The financial deficit for the implementation of industry modernization programs requires a new ideology in the approach to attracting extra-budgetary funds. Speaking about the forecast for the development of the primary health care in the Russian Federation, a number of experts point to three probable development scenarios. The first scenario is the continuation of the development of the industry within the framework of current trends. The second is modernization and transition to a new technological level. The third is a radical transformation of the structure and approaches while maintaining the current material and technical structure. The use of PPP tools can be a driver of the second and third scenarios. A wide range of stakeholders allows taking into account more aspects of project implementation. A multidisciplinary and intersectoral approach will improve more aspects in project implementation.