Статья
Назначение лекарственных препаратов по показаниям, не указанным в инструкции («off-label»): сложная проблема современной клинической практики
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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