myrwdРеальная клиническая практика: данные и доказательстваReal-World Data & Evidence2782-3784Publishing House OKI10.37489/2782-3784-myrwd-48APSBCTmyrwd-62Research ArticleБЕЗОПАСНОСТЬ ЛЕКАРСТВDRUG SAFETYСовременные проблемы off-label применения лекарственных средств и пути их решенияCurrent issues related to the off-label use of drugs and their potential solutionshttps://orcid.org/0000-0003-2121-094XРадаеваК. С.RadaevaK. S.

Радаева Ксения Сергеевна — ординатор кафедры клинической фармакологии и доказательной медицины

Санкт-Петербург

Kseniia S. Radaeva — Resident of the Department of Clinical Pharmacology and Evidence-Based Medicine

St. Petersburg

xenrada@gmail.comhttps://orcid.org/0000-0002-9692-2370МишиноваС. А.MishinovaS. A.

Мишинова Софья Андреевна — ассистент кафедры клинической фармакологии и доказательной медицины

Санкт-Петербург

Sofya A. Mishinova — Assistant of the Department of Clinical Pharmacology and Evidence-Based Medicine

St. Petersburg

milkkasha@mail.ruФГБОУ ВО «Первый Санкт-Петербургский государственный медицинский университет имени академика И. П. Павлова» МЗ РФРоссияFirst St. Petersburg State Medical University, named after I. P. PavlovRussian Federation202430032024412431Copyright © Радаева К.С., Мишинова С.А., 20242024Радаева К.С., Мишинова С.А.Radaeva K.S., Mishinova S.A.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.myrwd.ru/jour/article/view/62Актуальность

Актуальность. Off-label использование лекарственных средств (ЛС) широко распространено в клинической практике. В ответ на возрастающий интерес к данной проблеме, Международное общество фармокоэпидемиологии (International Society for Pharmacoepidemiology; ISPE) разработало новые общие рекомендации по off-label назначению лекарств в клинической практике, подчёркивая важность доказательной медицины и способствуя прозрачности ком­муникации между медицинскими работниками и пациентами.

Цель работы — изучить и представить основные тенденции по оптимизации принятия решений об off-label назначении ЛС на основе рекомендаций ISPE (2023 г.).

Результаты

Результаты. Были выделены 5 основных рекомендаций: поиск убедительных научных доказательств (включая использование данных реальной клинической практики), использование экспертных знаний при оценке и обобщении доказательств, строгая последовательность в формулировании рекомендаций, согласование использования лекарств off-label с исследованиями и укрепление сотрудничества между регуляторами, исследователями, врачами и фармацевтической промышленностью.

Выводы

Выводы. Решение проблемы off-label использования ЛС требует комплексного подхода. Реализация этих инициатив позволит снизить риски, связанные с off-label применением, получить устойчивые научные доказательства и улучшить качество лечения пациентов.

Relevance

Relevance. Off-label use of medications is a common practice in clinical settings. To address the growing interest in this issue, the International Society for Pharmacoepidemiology (ISPE) has developed new general guidelines for off-label prescribing in clinical practice that emphasize the importance of evidence-based medicine and promote transparent communication between healthcare professionals and patients.

Objective

Objective. The aim of this work was to analyze and present key trends for optimizing off-label prescribing decisions based on the ISPE recommendations (2023).

Results

Results. The report highlights five main recommendations: seeking strong scientific evidence, including the use of real-world data; using expert knowledge to evaluate and summarize evidence; developing recommendations with rigorous consistency; aligning the use of off-label medications with research; and strengthening collaboration among regulators, researchers, clinicians, and the pharmaceutical industry.

Conclusions

Conclusions. A comprehensive approach is required to address the problem of off-label use of medicines. Implementation of these initiatives will reduce the risks associated with off-label use, generate sustainable scientific evidence, and improve the quality of patient care.

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