Open AccessGeneric substitutions of antiepileptic drugs: Is it possible to put an end to the discussion?
Author(s) -
Е. А. Ушкалова,
S. K. Zyryanov,
К. Э. Затолочина
Publication year - 2018
Publication title -
nevrologiâ, nejropsihiatriâ, psihosomatika
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.157
H-Index - 9
eISSN - 2310-1342
pISSN - 2074-2711
DOI - 10.14412/2074-2711-2018-1s-75-80
Subject(s) - antiepileptic drug , brand names , pharmacotherapy , quality (philosophy) , epilepsy , business , medicine , risk analysis (engineering) , pharmacology , intensive care medicine , marketing , psychiatry , philosophy , epistemology
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.