Утверждён список заболеваний, при которых можно назначать лекарства off-label
Правительство России утвердило список заболеваний, при которых лекарственные препараты могут быть назначены не по показаниям, указанным в инструкции по применению. Соответствующее распоряжение от 16.05.2022 № 1180‑р опубликовано 17 мая.
Напомним, что согласно принятым в прошлом году поправкам в федеральный закон № 323‑ФЗ «Об основах охраны здоровья» в стандарты медицинской помощи и клинические рекомендации возможно включать лекарственные препараты вне инструкции по их применению (т. н. назначение off-label). Например, это могут быть препараты, в инструкции которых нет показания к применению у пациентов детского возраста, или лекарства, которые показали свою эффективность в ограниченных научных исследованиях.
Всего в перечень вошло 21 заболевание, группа заболеваний или состояние:
- Некоторые инфекционные и паразитарные болезни.
- Новообразования.
- Болезни крови, кроветворных органов и отдельные нарушения, вовлекающие иммунный механизм.
- Болезни эндокринной системы, расстройства питания и нарушения обмена веществ.
- Психические расстройства и расстройства поведения.
- Болезни нервной системы.
- Болезни глаза и его придаточного аппарата.
- Болезни уха и сосцевидного отростка.
- Болезни системы кровообращения.
- Болезни органов дыхания.
- Болезни органов пищеварения.
- Болезни кожи и подкожной клетчатки.
- Болезни костно-мышечной системы и соединительной ткани.
- Болезни мочеполовой системы.
- Беременность, роды и послеродовой период.
- Отдельные состояния, возникающие в перинатальном периоде.
- Врождённые аномалии [пороки развития], деформации и хромосомные нарушения.
- Травмы, отравления и некоторые другие последствия воздействия внешних причин.
- COVID-19.
- Паллиативная помощь.
- Донор костного мозга (в части лиц до 18 лет).
Назначение лекарственных препаратов вне инструкции по применению для пациентов с соответствующими диагнозами станет возможно с 29 июня — именно с этой даты распоряжение вступает в силу.
19 мая 2022
Фото: © Sepy / Фотобанк Фотодженика
Выпуск: №221, май 2022809 просмотров
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