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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">rfhealth</journal-id><journal-title-group><journal-title xml:lang="ru">Здравоохранение Российской Федерации</journal-title><trans-title-group xml:lang="en"><trans-title>Health care of the Russian Federation</trans-title></trans-title-group></journal-title-group><issn pub-type="ppub">0044-197X</issn><issn pub-type="epub">2412-0723</issn><publisher><publisher-name>Federal Scientific Center of Hygiene named after F.F. Erisman</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="doi">10.47470/0044-197X-2026-70-1-43-49</article-id><article-id custom-type="edn" pub-id-type="custom">yjccue</article-id><article-id custom-type="elpub" pub-id-type="custom">rfhealth-2137</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>ПРОФИЛАКТИКА ИНФЕКЦИОННЫХ ЗАБОЛЕВАНИЙ</subject></subj-group><subj-group subj-group-type="section-heading" xml:lang="en"><subject>PREVENTION OF INFECTIOUS DISEASES</subject></subj-group></article-categories><title-group><article-title>Усиление надзора со стороны Управления по контролю за продуктами питания и лекарствами Индонезии в борьбе с антибиотикорезистентностью: пробелы в регулировании и комплексные решени</article-title><trans-title-group xml:lang="en"><trans-title>Enhancing Indonesian FDA Supervision to Combat Antimicrobial Resistance: Regulatory Gaps and Multifaceted Solutions</trans-title></trans-title-group></title-group><contrib-group><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0001-6184-4803</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Розалина</surname><given-names>Адженг Илластрия</given-names></name><name name-style="western" xml:lang="en"><surname>Rosalina</surname><given-names>Ajeng Illastria</given-names></name></name-alternatives><bio xml:lang="ru"><p>Магистр, С. Фарм., Апт., М. Фарм. Менеджер индонезийского регионального офиса FDA в Джакарте, 13870, Джакарта, Республика Индонезия</p><p>e-mail: ajengrosalyne.air@gmail.com</p></bio><bio xml:lang="en"><p>Master, S. Farm., Apt., M. Farm. Manager Indonesian FDA Regional Office in Jakarta, 13870, Jakarta, Republic of Indonesia</p><p>e-mail: ajengrosalyne.air@gmail.com</p></bio><email xlink:type="simple">ajengrosalyne.air@gmail.com</email><xref ref-type="aff" rid="aff-1"/></contrib></contrib-group><aff-alternatives id="aff-1"><aff xml:lang="ru">Региональное отделение Управления по контролю за продуктами питания и лекарствами<country>Россия</country></aff><aff xml:lang="en">Indonesian FDA Regional Office in Jakarta<country>Russian Federation</country></aff></aff-alternatives><pub-date pub-type="collection"><year>2026</year></pub-date><pub-date pub-type="epub"><day>04</day><month>03</month><year>2026</year></pub-date><volume>70</volume><issue>1</issue><fpage>43</fpage><lpage>49</lpage><permissions><copyright-statement>Copyright &amp;#x00A9; Розалина А., 2026</copyright-statement><copyright-year>2026</copyright-year><copyright-holder xml:lang="ru">Розалина А.</copyright-holder><copyright-holder xml:lang="en">Rosalina A.</copyright-holder><license 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.rfhealth.ru/jour/article/view/2137">https://www.rfhealth.ru/jour/article/view/2137</self-uri><abstract><sec><title>Введение</title><p>Введение. В Индонезии растущую угрозу для общественного здравоохранения представляет собой антибиотикорезистентность, усугубляемая широко распространённой безрецептурной продажей антибиотиков (АБ) и ограниченной эффективностью регулирования.</p><p>Цель исследования — оценить соблюдение режима приёма лекарств по рецепту, структуру поставок АБ и нарушения нормативных требований путём анализа данных за 2023 г. из регионального отделения Управления по контролю за продуктами питания и лекарствами Индонезии в Джакарте.</p></sec><sec><title>Материалы и методы</title><p>Материалы и методы. Проанализированы данные проверок, проведённых в 2023 г. в 105 аптеках Джакарты, отобранных случайным и целенаправленным образом из 2735 зарегистрированных учреждений, для оценки соблюдения рецептурных требований, моделей поставок и нарушений нормативных требований. Используя метод поперечных срезов, проанализировали отпуск АБ по рецепту, задокументировали объём запасов, установили часто отпускаемые АБ и исследовали поводы для безрецептурной продажи.</p></sec><sec><title>Результаты</title><p>Результаты. Оказалось, что 37% АБ были отпущены без рецепта, что подчёркивает широкую распространённость самолечения. В основном, отпускали амоксициллин (63%), за которым следовали цефиксим и метронидазол, что повышает риск развития резистентности. Административные меры, в основном административные, оказались неэффективными; в частности, 20% безрецептурных АБ были закуплены нелегальными акушерками, что указывает на несовершенство мер надзора. Фрагментированное обучение медицинских работников и населения ещё больше ограничивает усилия по борьбе с устойчивостью к АБ.</p></sec><sec><title>Ограничение исследования</title><p>Ограничение исследования. Исследование ограничено учётом данных инспекций за один год, из одного региона, что может не отражать тенденции в других регионах Индонезии или текущие изменения в фармацевтической практике.</p></sec><sec><title>Выводы</title><p>Выводы. Для решения этих системных проблем мы рекомендуем ужесточить наказания, усилить надзор, особенно в отношении акушерской практики, осуществлять мониторинг продаж в режиме реального времени, проводить комплексные кампании по информированию общественности в соответствии с рекомендациями ВОЗ и координировать усилия различных ведомств по контролю за онлайн-продажей АБ.</p><p>Соблюдение этических стандартов. Для проведения исследования не требуется предоставление заключения комитета по биомедицинской этике или других документов.</p></sec><sec><title>Финансирование</title><p>Финансирование. Исследование не финансировалось.</p></sec><sec><title>Конфликт интересов</title><p>Конфликт интересов. Автор заявляет об отсутствии конфликта интересов.</p></sec><sec><title>Поступила</title><p>Поступила: 23.06.2025 / Поступила после доработки: 25.11.2025 / Принята к печати: 17.12.2025 / Опубликована: 04.03.2026</p></sec></abstract><trans-abstract xml:lang="en"><sec><title>Introduction</title><p>Introduction. Antimicrobial resistance (AMR) is a mounting public health threat in Indonesia, fueled by widespread non-prescription antibiotic sales and limited regulatory effectiveness.</p></sec><sec><title>The purpose of the study</title><p>The purpose of the study. The purpose of this study was to assess prescription adherence, patterns of antibiotic supply, and regulatory violations by analyzing 2023 data from the Indonesian Food and Drug Authority’s Jakarta Regional Office.</p></sec><sec><title>Materials and methods</title><p>Materials and methods. This study analyzes 2023 inspection data from 105 Jakarta pharmacies, randomly and purposively sampled from 2,735 registered facilities, to assess prescription compliance, supply patterns, and regulatory breaches. Using a cross-sectional approach, we examined antibiotic dispensing against prescription records, documented stock levels, identified frequently supplied antibiotics, and explored the reasoning for non-prescription sales.</p></sec><sec><title>Results</title><p>Results. Results revealed that 37% of antibiotics were provided without prescriptions, highlighting pervasive self-medication. Amoxicillin dominated supplies (63%), followed by Cefixime and Metronidazole, heightening resistance risks. Regulatory tools, mainly administrative reprimands, proved inadequate; notably, 20% of non-prescription antibiotics were distributed to unregulated midwives, underscoring oversight weaknesses. Fragmented education among health providers and the public further limits efforts to curb AMR.</p></sec><sec><title>Research limitation</title><p>Research limitation. The study is limited by its reliance on inspection data from a single year and region, which may not capture trends elsewhere in Indonesia or ongoing changes in pharmacy practice.</p></sec><sec><title>Conclusions</title><p>Conclusions. To address these systemic issues, we recommend stronger penalties, enhanced oversight — especially regarding midwife practices — real-time sales monitoring, integrated public education campaigns aligned with WHO guidance, and coordinated efforts across agencies to control online antibiotic sales.</p><p>Compliance with ethical standards. The study does not require submission of the opinion of the biomedical ethics committee or other documents.</p></sec><sec><title>Funding</title><p>Funding. The study had no sponsorship.</p></sec><sec><title>Conflict of interest</title><p>Conflict of interest. The authors declare no conflict of interest.</p></sec><sec><title>Received</title><p>Received: June 23, 2025 / Revised: November 25, 2025 / Accepted: December 17, 2025 / Published: March 4, 2026</p></sec></trans-abstract><kwd-group xml:lang="ru"><kwd>антибиотикорезистентность</kwd><kwd>Индонезийское управление по контролю за продуктами питания и лекарствами</kwd><kwd>свободная продажа антибиотиков</kwd><kwd>контроль за соблюдением нормативных требований в фармацевтической отрасли</kwd></kwd-group><kwd-group xml:lang="en"><kwd>antimicrobial resistance</kwd><kwd>Indonesian FDA</kwd><kwd>non-prescription antibiotic sales</kwd><kwd>pharmaceutical regulatory enforcement</kwd></kwd-group></article-meta></front><back><ref-list><title>References</title><ref id="cit1"><label>1</label><citation-alternatives><mixed-citation xml:lang="ru">Annunziato G. 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