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<article article-type="research-article" dtd-version="1.3" xmlns:mml="http://www.w3.org/1998/Math/MathML" xmlns:xlink="http://www.w3.org/1999/xlink" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xml:lang="ru"><front><journal-meta><journal-id journal-id-type="publisher-id">vedomostiregmed</journal-id><journal-title-group><journal-title xml:lang="ru">Регуляторные исследования и экспертиза лекарственных средств</journal-title><trans-title-group xml:lang="en"><trans-title>Regulatory Research and Medicine Evaluation</trans-title></trans-title-group></journal-title-group><issn pub-type="ppub">3034-3062</issn><issn pub-type="epub">3034-3453</issn><publisher><publisher-name>Federal State Budgetary Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ of the Ministry of Health of the Russian Federation (FSBI ‘SCEEMP’)</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="doi">10.30895/1991-2919-2024-14-4-419-436</article-id><article-id custom-type="elpub" pub-id-type="custom">vedomostiregmed-663</article-id><article-categories><subj-group subj-group-type="heading"><subject>Research Article</subject></subj-group><subj-group subj-group-type="section-heading" xml:lang="ru"><subject>Главная тема: АПТЕЧНОЕ ИЗГОТОВЛЕНИЕ: ЗА ДАЧИ, ПРОБЛЕМЫ, ПУТИ РЕШЕНИЯ</subject></subj-group><subj-group subj-group-type="section-heading" xml:lang="en"><subject>Main topic: PHARMACY COMPOUNDING: TASKS, PROBLEMS, SOLUTIONS</subject></subj-group></article-categories><title-group><article-title>Развитие экстемпорального изготовления лекарственных препаратов как инициирующий фактор трансформации фармацевтического образования: международный опыт и современные тренды</article-title><trans-title-group xml:lang="en"><trans-title>Development of Extemporaneous Compounding as an Initiating Factor in the Transformation of Pharmaceutical Education: International Experience and Current Trends</trans-title></trans-title-group></title-group><contrib-group><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0002-3558-9615</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Мандрик</surname><given-names>М. А.</given-names></name><name name-style="western" xml:lang="en"><surname>Mandrik</surname><given-names>M. A.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Мандрик Марк Александрович </p><p>ул. Трубецкая, д. 8, стр. 2, Москва, 119991</p></bio><bio xml:lang="en"><p>Mark A. Mandrik</p><p>8/2 Trubetskaya St., Moscow 119991, Russian Federation</p></bio><email xlink:type="simple">marubini@mail.ru</email><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0001-8375-9909</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Садковский</surname><given-names>И. А.</given-names></name><name name-style="western" xml:lang="en"><surname>Sadkovskii</surname><given-names>I. A.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Садковский Иван Александрович </p><p>ул. Трубецкая, д. 8, стр. 2, Москва, 119991</p></bio><bio xml:lang="en"><p>Ivan A. Sadkovskii</p><p>8/2 Trubetskaya St., Moscow 119991, Russian Federation</p></bio><email xlink:type="simple">sadkovskiy_i_a@staff.sechenov.ru</email><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0001-5919-1866</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Король</surname><given-names>Л. А.</given-names></name><name name-style="western" xml:lang="en"><surname>Korol</surname><given-names>L. A.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Король Людмила Анатольевна, канд. фарм. наук, доцент</p><p>ул. Трубецкая, д. 8, стр. 2, Москва, 119991</p></bio><bio xml:lang="en"><p>Ludmila A. Korol, Cand. Sci. (Pharm.), Associate Professor</p><p>8/2 Trubetskaya St., Moscow 119991, Russian Federation</p></bio><email xlink:type="simple">korol_l_a@staff.sechenov.ru</email><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0001-7671-3179</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Егорова</surname><given-names>С. Н.</given-names></name><name name-style="western" xml:lang="en"><surname>Egorova</surname><given-names>S. N.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Егорова Светлана Николаевна, д-р фарм. наук, профессор </p><p>ул. Бутлерова, д. 49, Казань, 420012</p></bio><bio xml:lang="en"><p>Svetlana N. Egorova, Dr. Sci. (Pharm.), Professor</p><p>49 Butlerov St., Kazan 420012, Russian Federation </p></bio><email xlink:type="simple">svetlana.egorova@kazangmu.ru</email><xref ref-type="aff" rid="aff-2"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0002-7242-2988</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Краснюк</surname><given-names>И. И.</given-names></name><name name-style="western" xml:lang="en"><surname>Krasnyuk</surname><given-names>I. I.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Краснюк Иван Иванович, д-р фарм. наук, профессор</p><p>ул. Трубецкая, д. 8, стр. 2, Москва, 119991</p><p> </p></bio><bio xml:lang="en"><p>Ivan I. Krasnyuk, Dr. Sci. (Pharm.), Professor</p><p>8/2 Trubetskaya St., Moscow 119991, Russian Federation</p></bio><email xlink:type="simple">krasnyuk_i_i@staff.sechenov.ru</email><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Быков</surname><given-names>А. В.</given-names></name><name name-style="western" xml:lang="en"><surname>Bykov</surname><given-names>A. V.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Быков Александр Васильевич, канд. мед. наук </p><p>ул. Берзарина, д. 19 к. 1, Москва 123154</p></bio><bio xml:lang="en"><p>Aleksandr V. Bykov, Cand. Sci. (Med.)</p><p>19 Berzarin St., Moscow 123154, Russian Federation</p></bio><email xlink:type="simple">av.bykov@rpharm.ru</email><xref ref-type="aff" rid="aff-3"/></contrib></contrib-group><aff-alternatives id="aff-1"><aff xml:lang="ru"><institution>Федеральное государственное автономное образовательное учреждение высшего образования «Первый Московский государственный медицинский университет имени И. М. Сеченова» Министерства здравоохранения Российской Федерации (Сеченовский Университет)</institution><country>Россия</country></aff><aff xml:lang="en"><institution>I.M. Sechenov First Moscow State Medical University (Sechenov University)</institution><country>Russian Federation</country></aff></aff-alternatives><aff-alternatives id="aff-2"><aff xml:lang="ru"><institution>Федеральное государственное бюджетное образовательное учреждение высшего образования «Казанский государственный медицинский университет» Министерства здравоохранения Российской Федерации</institution><country>Россия</country></aff><aff xml:lang="en"><institution>Kazan State Medical University</institution><country>Russian Federation</country></aff></aff-alternatives><aff-alternatives id="aff-3"><aff xml:lang="ru"><institution>Акционерное общество «Р-Фарм»</institution><country>Россия</country></aff><aff xml:lang="en"><institution>R-Pharm</institution><country>Russian Federation</country></aff></aff-alternatives><pub-date pub-type="collection"><year>2024</year></pub-date><pub-date pub-type="epub"><day>28</day><month>08</month><year>2024</year></pub-date><volume>14</volume><issue>4</issue><fpage>419</fpage><lpage>436</lpage><permissions><copyright-statement>Copyright &amp;#x00A9; Мандрик М.А., Садковский И.А., Король Л.А., Егорова С.Н., Краснюк И.И., Быков А.В., 2024</copyright-statement><copyright-year>2024</copyright-year><copyright-holder xml:lang="ru">Мандрик М.А., Садковский И.А., Король Л.А., Егорова С.Н., Краснюк И.И., Быков А.В.</copyright-holder><copyright-holder xml:lang="en">Mandrik M.A., Sadkovskii I.A., Korol L.A., Egorova S.N., Krasnyuk I.I., Bykov A.V.</copyright-holder><license xml:lang="ru" license-type="creative-commons-attribution" xlink:href="https://creativecommons.org/licenses/by/4.0/" xlink:type="simple"><license-p>Данная работа распространяется под лицензией Creative Commons Attribution 4.0.</license-p></license><license xml:lang="en" license-type="creative-commons-attribution" xlink:href="https://creativecommons.org/licenses/by/4.0/" xlink:type="simple"><license-p>This work is licensed under a Creative Commons Attribution 4.0 License.</license-p></license></permissions><self-uri xlink:href="https://www.vedomostincesmp.ru/jour/article/view/663">https://www.vedomostincesmp.ru/jour/article/view/663</self-uri><abstract><sec><title>ВВЕДЕНИЕ</title><p>ВВЕДЕНИЕ. Возрождению экстемпорального изготовления лекарственных препаратов в Российской Федерации в настоящий момент уделяется много внимания на всех уровнях медицинского и фармацевтического сообщества. Обладая значительным потенциалом роста в Российской Федерации, рынок аптечных лекарственных препаратов нуждается в высококвалифицированных кадрах, которые смогут обеспечить работу системы производственных аптечных учреждений и надлежащее качество экстемпоральных препаратов. Эффективность подготовки таких специалистов может быть повышена путем использования элементов опыта учебных заведений стран с развитой системой аптечного изготовления.</p></sec><sec><title>ЦЕЛЬ</title><p>ЦЕЛЬ. Определение основных направлений и анализ специфики подготовки специалистов в экстемпоральном изготовлении лекарственных препаратов в ведущих зарубежных образовательных организациях.</p></sec><sec><title>МАТЕРИАЛЫ И МЕТОДЫ</title><p>МАТЕРИАЛЫ И МЕТОДЫ. В исследовании были использованы методы логического, сравнительного, структурного и контент-анализа. Проанализированы 106 образовательных программ топ-25 высших учебных заведений, в соответствии с рейтингом QS World University Rankings по направлению «Фармация и фармакология». Анализ учебных программ осуществлялся посредством анализа открытых данных, размещенных в сети интернет, в том числе на официальных веб-сайтах образовательных организаций.</p></sec><sec><title>РЕЗУЛЬТАТЫ</title><p>РЕЗУЛЬТАТЫ. Показаны особенности подготовки специалистов разного уровня образования в области экстемпорального изготовления лекарственных препаратов, включая: требования, предъявляемые к абитуриентам; сроки обучения; стандарты компетенций; структуру экзаменов; порядок допуска к профессиональной деятельности с учетом национальных особенностей. Определены основные тренды обучения фармацевтических работников экстемпоральному изготовлению лекарственных препаратов, среди которых: снижение сроков подготовки специалистов среднего звена; углубленное изучение клинических дисциплин, обусловленное расширением полномочий фармацевтических работников; специализация по направлениям экстемпорального изготовления лекарственных препаратов: детских, стоматологических, стерильных, ветеринарных, радиофармацевтических, предназначенных для лечения орфанных заболеваний; использование технологий симуляционного и онлайн-обучения, развитие системы дополнительного профессионального образования.</p></sec><sec><title>ВЫВОДЫ</title><p>ВЫВОДЫ. В программы фармацевтического образования ведущих зарубежных образовательных организаций включено освоение дисциплин, связанных с направлением экстемпорального изготовления. Современные международные тренды, касающиеся получения специализации фармацевтическими работниками в области изготовления лекарственных препаратов; интеграции в образовательный процесс технологий симуляционного и онлайн-обучения; развития системы дополнительного профессионального образования, коррелируют с направлениями развития фармацевтического образования в Российской Федерации. При этом формирование дополнительных профессиональных компетенций в сфере аптечного изготовления детских, стерильных, химиотерапевтических, радиофармацевтических, ветеринарных, стоматологических лекарственных препаратов, которое за рубежом осуществляется за счет получения фармацевтическими специалистами специализации посредством освоения программ дополнительного профессионального образования, в Российской Федерации может быть реализовано на уровне дополнительных образовательных программ повышения квалификации и обучения в ординатуре.</p></sec><sec><title> </title><p> </p></sec></abstract><trans-abstract xml:lang="en"><sec><title>INTRODUCTION</title><p>INTRODUCTION. Currently, stakeholders across the Russian medical and pharmaceutical community are focusing on the restoration of national pharmaceutical compounding. The Russian pharmaceutical compounding market, with its great potential for growth, requires highly qualified professionals able to ensure the operation of compounding pharmacies and the proper quality of extemporaneous medicinal products. The effectiveness of training for such specialists can be improved by analysing the experience of educational institutions in countries with developed pharmaceutical compounding systems.</p></sec><sec><title>AIM</title><p>AIM. This study aimed to analyse the distinguishing features of training for pharmaceutical compounding specialists, as well as determine the main trends in pharmaceutical compounding education in leading international academic institutions.</p></sec><sec><title>MATERIALS AND METHODS</title><p>MATERIALS AND METHODS. The study used methods of logical, comparative, structural, and content analysis. The analysis covered 106 pharmacy and pharmacology curricula of the top-25 higher education providers from the QS World University Rankings by Quacquarelli Symonds. The curricula were analysed using open data published online, particularly, on the official websites of the selected universities.</p></sec><sec><title>RESULTS</title><p>RESULTS. The article presents the distinguishing features of pharmaceutical compounding education at different academic qualification levels; these features include the requirements for applicants, time to degree, competence standards, structure of exams, and specifics of students’ professional engagement, with consideration of the national context. The key trends in the education of specialists in pharmaceutical compounding include a decrease in training time for mid-level specialists; a tendency towards concentrating on clinical disciplines due to the expansion of the roles of pharmacy professionals; a growing focus on specialisation in the areas of paediatric, dental, sterile, veterinary, radiopharmaceutical, and orphan drug compounding; increasing use of simulated practice experiences and online learning technologies; and the development of continuing professional education systems.</p></sec><sec><title>CONCLUSIONS</title><p>CONCLUSIONS. Pharmaceutical education programmes of leading international educational organisations include disciplines related to extemporaneous compounding. Current international trends—pharmaceutical education with further specialisation in extemporaneous compounding, integration of simulation technologies and online learning into the educational process, and development of continuing professional education—coincide with the development directions of pharmaceutical education in the Russian Federation. Whereas international pharmacy specialists complete additional professional education programmes to gain an additional specialisation in the extemporaneous preparation of paediatric medicinal products, sterile dosage forms, chemotherapy products, radiopharmaceuticals, veterinary products, and dental products, Russian specialists can acquire these additional competencies through further education programmes at the levels of advanced training and residency.</p></sec></trans-abstract><kwd-group xml:lang="ru"><kwd>фармацевтическое образование</kwd><kwd>экстемпоральное изготовление</kwd><kwd>аккредитация</kwd><kwd>аптечный технический специалист</kwd><kwd>лицензирование</kwd><kwd>фармацевтические работники</kwd><kwd>производственные аптеки</kwd><kwd>зарубежный опыт</kwd></kwd-group><kwd-group xml:lang="en"><kwd>pharmaceutical education</kwd><kwd>extemporaneous compounding</kwd><kwd>accreditation</kwd><kwd>pharmacy technician</kwd><kwd>licensing of pharmaceutical workers</kwd><kwd>compounding pharmacies</kwd><kwd>international experience</kwd></kwd-group><funding-group><funding-statement xml:lang="en">The study was performed without external funding.</funding-statement></funding-group></article-meta></front><back><ref-list><title>References</title><ref id="cit1"><label>1</label><citation-alternatives><mixed-citation xml:lang="ru">Наркевич ИА, Фисенко ВС, Голант ЗМ, Юрочкин ДС, Мамедов ДД, Эрдни-Гаряев СЭ, Лешкевич АА. 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