safetyriskБезопасность и риск фармакотерапииSafety and Risk of Pharmacotherapy2312-78212619-1164Federal State Budgetary Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ of the Ministry of Health of the Russian Federation (FSBI ‘SCEEMP’)safetyrisk-17Research ArticleОБЗОРЫ И ОРИГИНАЛЬНЫЕ СТАТЬИREVIEWS AND ORIGINAL ARTICLESОсобенности подходов к оценке взаимозаменяемости противоэпилептических лекарственных средствPeculiarities of approaches to assessing the interchangeability of antiepileptic drugsЖуравлеваЕвгения ОлеговнаZhuravlevaE. O.Gyravleva@expmed.ruПастернакЕвгения ЮрьевнаPasternakE. Yu.noemail@neicon.ruЗатолочинаКарина ЭдуардовнаZatolochinaK. E.noemail@neicon.ruФедеральное государственное бюджетное учреждение «Научный центр экспертизы средств медицинского применения» Министерства здравоохранения Российской ФедерацииРоссия201520022018031321Copyright © Журавлева Е.О., Пастернак Е.Ю., Затолочина К.Э., 20182018Журавлева Е.О., Пастернак Е.Ю., Затолочина К.Э.Zhuravleva E.O., Pasternak E.Y., Zatolochina K.E.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.risksafety.ru/jour/article/view/17

Адекватность взаимозаменяемости оригинальных и воспроизведенных препаратов является важной социальной и экономической проблемой здравоохранения. В нашей статье рассматривается проблема замены противоэпилептических средств,которые могут проявлять терапевтическую неэквивалентность при подтвержденной биоэквивалентности. Результаты лечения такими препаратами могут сильно отличаться. Наряду с индивидуальными особенностями метаболизма на результатах лечения могут сказываться различные факторы: от режима питания больного до времени суток приема препарата. В работе описаны случаи, когда для замены одного препарата другим было необходимо наличие как био-,так и терапевтической эквивалентности. Представлены данные исследований взаимозаменяемости нейротропных препаратов в различных странах. В статье приводится классификация регуляторного органа Великобритании (MHRA) для оценки возможности замены препаратов с рекомендациями по минимизации рисков возникновения нежелательных реакций для использования в клинической практике.

The adequacy of the interchangeability of original and generic drugs is an important economic and social problem in healthcare. In this article we look at the problem of the replacement of antiepileptic drugs. Sometimes when their bioequivalence is proved they still can be not equivalent therapeutically. The results of the therapy for these kinds of drugs can differ. As well as the individual characteristics of the metabolism that can affect the results of the treatment, there are other possible factors - the diet of the patient or the time of day,when patient takes medication. The cases when for the replacement of one drug for another it was necessary to have both biological and therapeutic equivalence are described in this article. The research data of interchangeability of neurotropic drugs in different countries are presented. The article provides a classification of the Medicines and Healthcare products Regulatory Agency (MHRA) to estimate the possibility of replacement of drugs with recommendations to minimize the risk of adverse reactions for use in clinical practice.

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