Current Challenges of Preventive Vaccination Against Rabies

The urgency of the rabies problem for all mankind and the search for new ways of eradicating the disease entailed the creation of a new global initiative for rabies elimination ‒ «United Against Rabies» which sets a highly ambitious goal of achieving zero rabies human deaths by 2030. The many years of international experience in elimination of street dogs, which account for 99 % of rabies cases, did not produce the desired results, therefore the focus was shifted to mass vaccination of dogs (minimum 70 % of dog population). The rabies problem is complex and global, it requires efforts from all the parties involved as well as hefty investment. The paper presents the results of a continuous long-term analysis of the rabies situation in Russia and across the world, as well as analysis of the current state of vaccination against rabies which plays an important, if not crucial, role in prevention of rabies in humans who got bitten by infected animals. The paper formulates the main currently existing ways of solving the rabies problem, namely: mass vaccination of dogs; improvement of dosing schedules and administration routes of medicines against rabies; analysis of immunity development mechanisms in immunocompromised patients; progressive implementation of vaccination of people who got bitten by infected animals, and alternative administration routes; development of an express method of the neutralising antibody titer determination; raising public awareness about disease hazards

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Current State of the Vaccine Prophylaxis of Particularly Dangerous Infections

Considered are the problems of handling of the vaccine strains Yersinia pestis EV NIIEG, Bacillus anthracis STI-1, Francisella tularensis 15 NIIEG, and Brucella abortus 19 BA, utilized for manufacturing of live vaccines against particularly dangerous infections, in connection with absence of normative legal document, specifying the algorithm for storage and handling of strains after production stage throughout the shelf-life (10 years). It is indicated that under current conditions the system of handling and record keeping on the transfer of strains of vaccines against particularly dangerous infections is compromised. It has led to disruption of interdepartmental cooperation in the transfer, testing, maintenance, and storage of the latest manufactured batches

Оценка эффективности внедрения информационных систем для экспертизы лекарственных средств

Improvement of drug supply is one of the key factors contributing to the quality of medical services, but it cannot be achieved without introduction of digital technologies. This is a complex task that requires a systematic approach which includes planning, design, development, implementation and operation of information systems.The purpose of this study was to develop and test a procedure for assessing the effectiveness of information systems supporting medicines evaluation.Materials and methods: the paper analyses Russian and foreign scientific publications devoted to the assessment of effectiveness of information systems implementation. The author conducted a system analysis using the procedure for constructing a model of a data processing system.Results: the analysis of literature sources helped to determine methods that could be used to assess the effectiveness of information systems implementation. The «Document management — Medicines evaluation» system was used to construct a model system, and the analysis of the system’s effectiveness made it possible to propose ways for further improvement.Conclusion: the analysis of the literature sources demonstrated that the use of digital modelling methods helps to assess the effectiveness of information systems supporting medicines evaluation. The paper analysed the «Document management — Medicines evaluation» system used for receipt and registration of medicine samples. This system makes it possible to preplan the order in which applications will be received and rule out the possibility of simultaneous receipt of several applications. Based on the results of the analysis it is suggested that an additional receiving point should be set up in order to improve the throughput of the system.Совершенствование лекарственного обеспечения является одним из ключевых факторов повышения качества оказания медицинских услуг, но без внедрения цифровых технологий в этот процесс практически не обойтись. Внедрение цифровых технологий в сфере обращения лекарственных средств является комплексной задачей, требующей системного подхода, куда входит планирование, проектирование, разработка, внедрение и эксплуатация информационных систем.Цель работы: разработка и апробация методики оценки эффективности информационных систем, применяемых для экспертизы лекарственных средств.Материалы и методы: анализ научных публикаций отечественной и зарубежной специальной литературы по проблеме оценки эффективности внедрения информационных систем. Также был проведен системный анализ с использованием процедуры построения модели системы обработки данных.Результаты: на основе данных литературы определены методики, которые могут быть применены для оценки эффективности внедрения информационных систем. На примере системы «Документооборот — Экспертиза лекарственных средств» построена модель и проведена оценка эффективности этой системы. По результатам оценки предложены пути повышения эффективности модельной системы.Выводы: на основании анализа источников литературы показано, что применение методов цифрового моделирования позволяет анализировать эффективность информационных систем в сфере экспертизы лекарственных средств. В работе проанализирована система записи для приема образцов лекарственных средств «Документооборот — Экспертиза лекарственных средств», позволяющая распланировать очередность поступления заявок и исключить параллельное поступление нескольких обращений. По результатам анализа предложено повысить эффективность системы путем открытия дополнительного окна для приема заявителей

Vaccine interchangeability: problems and prospects

Vaccines by different manufacturers are available for most of the vaccine-preventable infections covered by the National Immunisation Schedule of the Russian Federation. Determination of the possibility of replacing a vaccine in the case of routine or emergency vaccination still remains a challenging issue. The aim of the study was to substantiate the problem of vaccine interchangeability, outline specific challenges and ways of solving them, analyse criteria underlying evaluation of vaccine interchangeability in Russia, and international experience in this area. The procedure for determining the interchangeability of biological products, including vaccines, was established in the Decree of the Government of the Russian Federation of 5 September 2020, No. 1360 “On the procedure for determination of interchangeability of medicinal products for human use”. The paper analyses the applicability of the official criteria for interchangeability of biological products, including vaccines. It outlines the main problems of performing evaluation of vaccine interchangeability in accordance with the established criteria. It is concluded that the vaccine interchangeability criteria need to be clarified in order to allow for assessment of comparability of active substances, and comparison of efficacy, safety, and immunogenicity of vaccines, taking into account vaccination schedules for different age groups. The possibility of evaluating interchangeability based on the results of post-authorisation studies also needs clarification. It is also necessary to align patient information leaflets for interchangeable vaccines

Современные проблемы вакцинопрофилактики бешенства

The urgency of the rabies problem for all mankind and the search for new ways of eradicating the disease entailed the creation of a new global initiative for rabies elimination ‒ «United Against Rabies» which sets a highly ambitious goal of achieving zero rabies human deaths by 2030. The many years of international experience in elimination of street dogs, which account for 99 % of rabies cases, did not produce the desired results, therefore the focus was shifted to mass vaccination of dogs (minimum 70 % of dog population). The rabies problem is complex and global, it requires efforts from all the parties involved as well as hefty investment. The paper presents the results of a continuous long-term analysis of the rabies situation in Russia and across the world, as well as analysis of the current state of vaccination against rabies which plays an important, if not crucial, role in prevention of rabies in humans who got bitten by infected animals. The paper formulates the main currently existing ways of solving the rabies problem, namely: mass vaccination of dogs; improvement of dosing schedules and administration routes of medicines against rabies; analysis of immunity development mechanisms in immunocompromised patients; progressive implementation of vaccination of people who got bitten by infected animals, and alternative administration routes; development of an express method of the neutralising antibody titer determination; raising public awareness about disease hazards.Актуальность проблемы бешенства для всего человечества, поиск новых путей искоренения инфекции привели к созданию новой глобальной системы для ликвидации бешенства – «Объединенные против бешенства», поставившей перед собой чрезвычайно амбициозную задачу по достижению нулевого уровня смертности людей от гидрофобии во всем мире к 2030 году. Принимая во внимание предыдущий многолетний мировой опыт уничтожения безнадзорных собак, на долю которых приходится 99 % случаев гидрофобии, что не привело к желаемому результату, в настоящее время взят курс на массовую вакцинацию собак (не менее 70 % популяции животных). Проблема бешенства комплексная, без усилия всех заинтересованных служб, серьезных финансовых затрат вряд ли удастся решить такую глобальную задачу. Материалы данной статьи являются результатом постоянного многолетнего анализа ситуации по бешенству в мире и в Российской Федерации, анализа современного состояния проблемы вакцинопрофилактики бешенства, которая играет огромную, если не ведущую, роль в предупреждении развития гидрофобии у людей, пострадавших от укусов больных бешенством животных. Сформулированы основные направления решения проблемы заболевания бешенством на современном этапе, а именно: массовая вакцинация собак; совершенствование схем и методов применения антирабических препаратов; изучение закономерностей образования иммунного ответа у лиц с ослабленным иммунитетом; постепенное внедрение в практику вакцинации людей, пострадавших от укусов больных бешенством животных, альтернативных методов введения препаратов; разработка экспресс-системы определения титров вируснейтрализующих антител; повышение уровня информированности населения об опасности заболевания

Prospects for intranasal drug delivery systems with Ginkgo biloba in the treatment of cerebral circulatory disorders

Purpose: To analyze the range of currently available nasal medicines, and to study extant information on the use of Ginkgo biloba herbal complexes for the treatment of cerebral circulatory disorders of different etiologies. The study dwelt on the features and prospects of intranasal drug administration. Currently, intranasal administration is used primarily for the treatment of local symptoms. However, it has a much higher potential: the mucous membrane of the nasal cavity offers an opportunity for noninvasive treatment using systemic administration. Methods: The study involved the analysis of materials from information-retrieval systems, library databases, patent databases, and scientific information repositories such as e-Library. PubMed, Scopus, Google Scholar, as well as materials from the websites of manufacturers of herbal medicinal products and other herbal substances. Results: Herbal medicinal products have great potential in terms of intranasal administration. This is especially true of herbal medicines obtained through extraction of leaves of Ginkgo biloba, which have a broad spectrum of action, i.e., anti-aggregatory, venotonic, nootropic, anti-hypoxic, antioxidant, antiinflammatory, membrane-stabilizing, and capillary-protective effects. The range of Ginkgo biloba-based medicines calls for expansion, and this testifies to a good potential of these products in terms of further research and use. The analysis of literature and technical information showed the existence of a wide range of nasal medicines currently in use. However, only few drugs are used for the treatment of cerebrovascular diseases. Furthermore, there are no herbal medicines among these drugs, despite obvious advantages of herbal products such as ease of use, high bioavailability, and systemic action potential. Conclusion: The current status of research on nasal dosage forms of Ginkgo biloba herbal complexes warrants further development involving biopharmaceutical and pharmacological studies

The Sixth Edition of the WHO laboratory manual for the examination and processing of human semen: is everything new a well-forgotten old?

Despite many shortcomings, the semen analysis remains the leading method of male fertility assessment. For several decades, the WHO has been working on standardisation of the methodology for examining human ejaculate. In 2021, the sixth edition of WHO laboratory manual for the examination and processing of human semen was released, which proposed several concepts for performing and interpreting the results of a semen analysis. Many of these concepts are not new and have already been covered in previous tutorials. At the same time, the rejection of reference values and the transition to “decision limits” raises several questions that have not yet been answered

Blood preparations of humans and animals in terms of their quality, efficacy and safety

The problems of quality and safety products derived from human blood plasma and hyperimmune animal sera as well as recombinant blood products resolved strict government regulation of their production processes. The risk of implications is minimized by plasma fractionation and purification of a specific drugs from various impurities (immunoglobulin aggregates, protease, plasmin, plasminogen, prekallikrein activator, IgA and IgM etc.). Viral safety is achieved by multi-step manufacturing process that includes at least two independent methods (treatment with solvent/detergent + incubation at low pH or pasteurization, combined with polyethylene glycol processing). It was justified that for today the technological process of the development of plasma preparations and hyperimmune animal sera has reached its limit. Their further development is the most likely to refer to specific improvements. The improvements will relate to increasing the efficiency of manufacturing technologies and methods of clinical use (preparations for subcutaneous administration, combinations of different immunoglobulin preparations, etc.), viral safety, ways to eliminate component, that were previously not considered to be able to influence the outcome of clinical use (soluble molecules CD4, CD8, HLA, thrombin, trace amounts of blood clotting factors VIII, IX, X, XI, XII etc.). At the same time new genetic engineered preparations with well-characterized molecular composition and a high selectivity for target impact are expected to appear on the market because of these unsolved issues. These are recombinant blood factors with altered properties; cocktails of recombinant antibodies and Fab-fragments of IgG, highly affine for toxin epitopes, etc. Therefore, in the upcoming years it is necessary to create in Russia a new system for assessing the quality, efficacy and safety of blood products, taking into account the future course of their development

Международные непатентованные наименования лекарственных средств: требования к формированию заявки и порядок экспертизы и регистрации Всемирной организацией здравоохранения

Brief information about the program of the World Health Organization (WHO) for International Nonproprietary Names (INN) for drugs and the role of the INN in the sphere of circulation of medicines is represented. The general principles of INN selection and requirements for development applications for the INN are described. The assignment of an INN of the pharmaceutical substance is the highest criterion for recognition by the international expert community of innovative medicines created by a particular developer and makes it possible to objectively judge the contribution of different countries in global health. Questions of functioning of the national system of the selection and introduction of INN for domestic original pharmaceutical medicines have the high urgency.Представлена обобщенная информация о программе Всемирной организации здравоохранения (ВОЗ) по международным непатентованным наименованиям (МНН) лекарственных средств и роли МНН в сфере обращения лекарственных средств. Отражены общие принципы выбора МНН и требования к формированию заявки на получение МНН. Присвоение МНН фармацевтической субстанции является высшим критерием признания международным экспертным сообществом инновационности лекарственного средства, созданного конкретным разработчиком и позволяет объективно судить о вкладе разных стран в глобальную систему охраны здоровья. Актуальным является вопрос функционирования национальной системы экспертного отбора и введения в действие МНН для оригинальных отечественных лекарственных средств