rpcardioRational Pharmacotherapy in CardiologyРациональная Фармакотерапия в Кардиологии1819-64462225-3653«SILICEA-POLIGRAF» LLC10.20996/1819-6446-2020-04-14rpcardio-2181Research ArticleCURRENT QUESTIONS OF CLINICAL PHARMACOLOGYАКТУАЛЬНЫЕ ВОПРОСЫ КЛИНИЧЕСКОЙ ФАРМАКОЛОГИИOff-Label Medicines Use: Complex Problem of Modern Clinical PracticeНазначение лекарственных препаратов по показаниям, не указанным в инструкции («off-label»): сложная проблема современной клинической практикиГиляревскийС. Р.GilyarevskiyS. R.

Гиляревский Сергей Руджерович – доктор медицинских наук, профессор, кафедра клинической фармакологии и терапии

125993, Москва, ул. Баррикадная, 2/1

Sergey R. Gilyarevskiy – MD, PhD, Professor, Chair of Clinical Pharmacology and Therapy

Barrikadnaya ul. 2/1, Moscow, 125993

sgilarevsky@rambler.ruРоссийская медицинская академия непрерывного профессионального образованияРоссияRussian Medical Academy of Continuing Professional EducationRussian Federation202002052020162324334Copyright © Gilyarevskiy S.R., 20202020Гиляревский С.Р.Gilyarevskiy S.R.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.rpcardio.online/jour/article/view/2181

World experience in off-label medicines use is presented in the article. Data on the history of changes in tactics and approaches to solve the problem of medicines off-label use in the USA and some European countries, as well as in the European Union as a whole, are presented. The reasons, why doctors should use medicines off-label, are discussed. The expert opinion on the conditions ensuring the maximum safety in off-label medicines use is presented. In particular, the validity of obtaining patient informed consent is discussed. The article does not apply to the Russian regulation regarding “off-label” therapy but describes the foreign practice related to off-label medicines use. In addition, the results of some recently completed randomized clinical trials evaluating the effects of direct oral anticoagulants are presented in order to demonstrate the need to clarify the effectiveness and safety of medicines used in certain clinical situations. The results of such studies clarify the indications for the drug use, which are subsequently entered into the summary of product characteristics.

В статье представлен мировой опыт назначения лекарственных препаратов в отсутствие формальных показаний, указанных в инструкции, т.е. назначения препаратов «off-label». Приводятся данные об истории изменения тактики использования препаратов и подходов к решению проблемы назначения «off-label» в Соединенных Штатах Америки и некоторых странах Европы, а также в целом в Европейском Союзе. Рассматриваются причины, по которым врачи вынуждены использовать препараты по показаниям, выходящим за пределы инструкции, прилагаемой к препарату. Отражено мнение экспертов об условиях, обеспечивающих максимальную безопасность применения лекарственных средств «off-label», в частности, обсуждается обоснованность получения информированного согласия пациента. Следует отметить, что статья не касается российского регулирования назначений терапии «off-label», а описывает зарубежную практику использования лекарственных препаратов в отсутствие формальных показаний, указанных в инструкции. Кроме того, в статье приведены результаты некоторых недавно завершенных рандомизированных клинических исследований по оценке эффектов прямых пероральных антикоагулянтов для того, чтобы продемонстрировать необходимость уточнения эффективности и безопасности препаратов, применяемых в узко определенных клинических ситуациях. Результаты таких исследований уточняют показания к применению препаратов, которые в последующем указываются в инструкции к ним.

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