Минздрав меняет правила отпуска препаратов с дицикловерином (скачать документ)
6 июня 2017
Выпуск:
№161, июнь 2017
3015 просмотров
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Минздрав меняет правила отпуска препаратов с дицикловерином (скачать документ)
Министерство здравоохранения опубликовало письмо с требованием о внесении изменений в инструкции по применению лекарственных средств, содержащих в качестве действующего вещества дицикловерин (как моно-, так комбинированные препараты). Для таких ЛС теперь станет обязательным требование отпуска только по рецепту. Документ был опубликован 2 июня на сайте Государственного реестра лекарственных средств.
Согласно данным из автоматизированной системы «Фармаконадзор» в Росздравнадзоре зафиксировано большое количество фактов злоупотребления препаратами, содержащими дицикловерин. Ведомство, совместно с Научным центром экспертизы средств медицинского применения (ФГБУ «НЦЭСМП»), считает, что дальнейший безрецептурный отпуск повышает риски, связанные с безопасностью применения таких препаратов.
В связи с этим в инструкции по применению всех препаратов, содержащих МНН дицикловерин, требуется внести следующие изменения:
— изменить условия отпуска на «Отпуск по рецепту»;
— в раздел «Побочное действие» добавить «галлюцинации (с неизвестной частотой)».
Дицикловерин содержится в препаратах, применяющихся для обезболивания при спазмах гладкой мускулатуры.
Минздрав пока не издал приказа об изменении правил отпуска препаратов с дицикловерином. Данное требование адресовано заявителям регистрации и производителям лекарственных средств.
В 2012 году в Калужской области, согласно закону, принятому местным правительством, лекарства, содержащие дицикловерин, были переведены на рецептурный отпуск. Однако этот закон был отменен в 2013 году по решению Верховного суда, посчитавшего, что региональные власти превысили свои полномочия. Согласно действующему законодательству правила отпуска может устанавливать только Минздрав.
Источники:
ГРЛС (PDF)
Regnum
Катрен Стиль
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