Приказ Минздрава №459н: важные изменения для медицинских организаций с 1 сентября 2024
С 1 сентября 2024 года начнет действовать Приказ Министерства здравоохранения Российской Федерации №459н, утверждающий новый перечень лекарственных средств, подлежащих предметно-количественному учету (ПКУ).
В обновленный список попали препараты с двумя МНН — мизопростол и мифепристон. Прегабалин, тропикамид и тапентадол были перемещены из раздела IV, охватывающего «Иные лекарственные средства, подлежащие ПКУ», в раздел II, который включает «Лекарственные средства — фармацевтические субстанции и препараты, относящиеся к сильнодействующим и ядовитым веществам по статье 234 и другим статьям Уголовного кодекса РФ».
В разделе II теперь также значатся два новых препарата: бромдигидрохлорфенилбензодиазепин и соматотропин (гормон роста).
Организации, которые не намерены работать с лекарственными средствами, подлежащими ПКУ, обязаны убрать их из ассортимента до 31 августа 2024 года.
Тем, кто будет продолжать работать с этими препаратами, нужно обратить внимание на следующие требования:
Назначить ответственное лицо за хранение и учет, а также вести журнал учета.
Разработать стандартные операционные процедуры (СОП) для работы с лекарственными средствами, подлежащими ПКУ.
Создать «Журнал учета операций, связанных с обращением лекарств для медицинского применения» (Приложение №2 к приказу МЗ №378 от 17.06.13) и хранить его в шкафу или сейфе в течение 3 лет.
Правильно оформлять и хранить рецептурные бланки 148-1/У-88, включая необходимую информацию на обратной стороне.
Хранить лекарства, подлежащие ПКУ, в металлических или деревянных шкафах, которые должны быть запечатаны в конце рабочего дня.
Все архивы необходимо хранить в сейфе в течение 3 лет, после чего утилизировать по акту уничтожения, который тоже должен храниться в аптеке в течение 3 лет.
Список препаратов, подлежащих ПКУ с 1 сентября 2024 года:
— С мизопростолом:
Женале
Мифедвест
Гинестрил
Миропристон
Внеплания
Мифепристон
Гинепристон
Мифегин
Мифолаин
Пенкрофтон
Мифепрекс
Агеста
— С мифепристоном:
Миролют
Мизопристол
— С циклопентолатом:
Мецитолин
Цикломед
Циклоптик
— С соматотропином (гормон роста):
Омнитроп
Растан
Динатроп
Джинтропин
Нордитропин
Обсуждение закрыто: комментарии принимаются, пока материалу меньше трёх месяцев.
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