clinvestКачественная клиническая практикаKachestvennaya Klinicheskaya Praktika = Good Clinical Practice2588-05192618-8473ООО «Издательство ОКИ10.37489/2588-0519-2025-2-46-65URCNGYclinvest-789Research ArticleБЕЗОПАСНОСТЬ ЛЕКАРСТВDRUG SAFETYИсследования безопасности лекарственных препаратов при беременности на основе данных из нормативных источников информации: систематический обзорDrug safety studies in pregnancy based on data from regulatory information sources: a systematic reviewhttps://orcid.org/0000-0003-3107-7636РешетькоО. В.ReshetkoO. V.

Ольга Вилоровна Решетько, д. м. н., профессор, зав. кафедрой

кафедра фармакологии

Саратов

Olga V. Reshetko, Dr. Sci. (Med.), Professor, Head of Department

Department of Pharmacology

Saratov

reshetko@yandex.ruhttps://orcid.org/0000-0002-8519-2181ЛуцевичК. А.LutsevichK. A.

Константин Александрович Луцевич, к. м. н., доцент

Саратов

Konstantin A. Lutsevich, Cand. Sci. (Med), Associate Professor

Saratov

lutsevich78@mail.ruЛуцевичТ. С.LutsevichT. S.

Татьяна Сергеевна Луцевич, врач-клинический фармаколог

Саратов

Tatjana S. Lutsevich, Clinical pharmacologist

Saratov

trits@mail.ruФГБОУ ВО «Саратовский государственный медицинский университет имени В. И. Разумовского»РоссияV.I. Razumovskiy Saratov State Medical UniversityRussian Federation202519072025024665Copyright © Решетько О.В., Луцевич К.А., Луцевич Т.С., 20252025Решетько О.В., Луцевич К.А., Луцевич Т.С.Reshetko O.V., Lutsevich K.A., Lutsevich T.S.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.clinvest.ru/jour/article/view/789   Актуальность

   Актуальность. Пренатальное воздействие лекарственных препаратов с тератогенным риском и профилактика такого воздействия являются важной клинической проблемой и проблемой общественного здравоохранения. Первоочередной задачей безопасного использования лекарственных препаратов женщинами репродуктивного возраста, в том числе во время беременности, является знание тератогенного риска и включение его в первичный источник информации.

   Цель

   Цель. Провести систематический обзор литературы с целью выявления и сравнения результатов исследований безопасности лекарственных препаратов, в которых имелись указания на использование данных из официально признанных информационных документов, при беременности.

   Материал и методы

   Материал и методы. Поиск литературы проводился в электронных базах данных MEDLINE/PubMed с 1 января 2000 г. по 30 июня 2024 г. с использованием специальных ключевых слов и терминов MeSH (Medical Subject Headings) в сочетании с логическими операторами «AND» и «OR». Для ручного отбора публикаций также использовалась поисковая система Google Scholar.

   Результаты

   Результаты. В результате поиска было обнаружено 24 публикации, которые имели отношение к изучаемой теме и были включены в анализ. Исследования нормативных документов по оценке полноты, применимости и безопасности информации о применении лекарственных препаратов при беременности (n = 3; 12,5 %) выявили отсутствие достаточных данных о людях. Сравнительные исследования несоответствий между различными источниками информации (n = 10;41,7 %) показали расхождения между странами в содержании информации о лекарственных препаратах, выпускаемых одними и теми же фармацевтическими компаниями, а также различия между разными источниками утверждённой информации. Ряд исследований (n = 5; 20,8 %) касались современных систем классификации рисков при беременности, эффективности информации для предупреждения о тератогенности лекарственных препаратов и адаптации её содержания к уровню восприятия риска. В США информация о назначении препарата разделена на специальные подразделы, содержание которых регулируется недавно опубликованным Правилом маркировки при беременности и лактации (PLLR), которое стало предметом особого интереса в нескольких исследованиях (n = 6; 25,0 %).

   Заключение

   Заключение. Растущее использование во время беременности лекарственных препаратов во всём мире и ежегодная регистрация новых препаратов, большинство из которых содержат ограниченную информацию о безопасности при беременности или не содержат её вовсе, подтверждают актуальность данного систематического обзора.

   Relevance

   Relevance. Prenatal exposure to medicines with a teratogenic risk and the prevention of such exposure is an important clinical and public health issue. The first priority for the safe use of medicines, both during pregnancy and by women of reproductive age, is to know the teratogenic risk and to include it in the primary source of information.

   Objective

   Objective. To conduct a systematic literature review to identify and compare the results of drug safety studies in pregnancy based on data from officially recognised information documents.

   Material and methods

   Material and methods. Literature searches were conducted in the electronic databases MEDLINE/PubMed from 1 January 2000 to 30 June 2024, using specific keywords and MeSH (Medical Subject Headings) terms in combination with the logical operators "AND" and "OR". The Google Scholar search engine has also been used for the manual selection of publications.

   Results

   Results. The search identified 24 publications that were relevant to the topic under study and were included in the analysis. Studies in regulatory documents assessing the completeness, applicability and safety of information on the use of the drug in pregnancy (n = 3; 12.5 %) revealed a lack of sufficient data on people. Comparative studies of inconsistencies between different sources of information (n = 10; 41.7 %) showed inconsistencies between countries in the content of information on medicines produced by the same pharmaceutical companies, as well as differences between different sources of approved information. A number of studies (n = 5; 20.8 %) focus on current systems of risk classification in pregnancy, the effectiveness of prescribing information to warn of the teratogenicity of medicines and the adaptation of its content to the level of risk perception. In the United States, prescription information is divided into specific subsections, the content of which is regulated by the recently published Pregnancy and Lactation Labeling Rule, which was the focus of several studies (n = 6; 25.0 %).

   Conclusion

   Conclusion. The increasing use of medicines in pregnancy worldwide and the annual registration of new medicines, most of which contain limited or no safety information in pregnancy, support the relevance of this systematic review.

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The authors declare that there are no conflicts of interest present.