nnpNeurology, Neuropsychiatry, PsychosomaticsНеврология, нейропсихиатрия, психосоматика2074-27112310-1342"IMA-Press", LLC10.14412/2074-2711-2018-1S-75-80nnp-913Research ArticleREVIEWSОБЗОРЫGeneric substitutions of antiepileptic drugs: Is it possible to put an end to the discussion?Генерические замены противоэпилептических препаратов: можно ли поставить точку в дискуссии?УшкаловаЕ. А.UshkalovaE. A.

Кафедра общей и клинической фармакологии

117198, Москва, ул. Миклухо-Маклая, 6

Department of General and Clinical Pharmacology

6, Miklukho-Maklai St., Moscow 117198

eushk@yandex.ruЗыряновС. К.ZyryanovS. K.

Кафедра общей и клинической фармакологии

117198, Москва, ул. Миклухо-Маклая, 6

Department of General and Clinical Pharmacology

6, Miklukho-Maklai St., Moscow 117198

ЗатолочинаК. Э.ZatolochinaK. E.

Кафедра общей и клинической фармакологии

117198, Москва, ул. Миклухо-Маклая, 6

Department of General and Clinical Pharmacology

6, Miklukho-Maklai St., Moscow 117198

ФГАОУ ВО «Российский университет дружбы народов»РоссияRUDN University of RussiaRussian Federation201818072018101SСПЕЦВЫПУСК: ЭПИЛЕПСИЯ7580Copyright © Ushkalova E.A., Zyryanov S.K., Zatolochina K.E., 20182018Ушкалова Е.А., Зырянов С.К., Затолочина К.Э.Ushkalova E.A., Zyryanov S.K., Zatolochina K.E.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://nnp.ima-press.net/nnp/article/view/913

A policy on generic substitutions, which is aimed at reducing the cost-effectiveness of pharmacotherapy, was proposed by the WHO at the end of the 20th century; however, but the debate about their  economic benefits has continued until now. There have been the  most active discussions of whether an epileptic patient may be  switched from brand-name to generic antiepileptic drugs. The paper  gives data obtained in Russian and foreign studies of the therapeutic  efficacy and safety of anticonvulsant generics versus their brand- name drugs, as well as the impact of generic substitutions on the cost-effectiveness of  antiepileptic therapy. Emphasis is placed on the importance of the  quality of generic medicines, their dosage forms, and regulatory requirements for registration of generics. The problem of generic instability is under discussion.

Политика генерических замен лекарственных средств с целью снижения стоимости фармакотерапии была предложена ВОЗ в конце прошлого века, однако дискуссия об их  экономических преимуществах не прекращается до настоящего времени. Наиболее активная  дискуссия о целесообразности переключения пациента с эпилепсией с оригинатора на генерик  развернулась в отношении противоэпилептических препаратов. В статье приводятся данные  отечественных и зарубежных исследований о терапевтической эффективности и безопасности  генериков антиконвульсантов по сравнению с оригинаторами и о влиянии генерических замен  на стоимость противоэпилептической терапии. Подчеркивается значение качества генериков,  их лекарственных форм и регуляторных требований, предъявляемых при регистрации  генериков. Обсуждается проблема «генерической неустойчивости».

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