Guberman A, Corman C
Division of Neurology, University of Ottawa, Ottawa Hospital, ON, Canada.
Can J Neurol Sci. 2000 Feb;27(1):37-43. doi: 10.1017/s0317167100051957.
BACKGROUND/OBJECTIVE: There are presently 26 different generic preparations for five brand name antiepileptic drugs (AEDs) on the Canadian market with others likely to be released in the near future. The purpose of this review is to examine the basis for the controversy surrounding generic substitution for brand name antiepileptic drugs, to present the results of a survey of neurologists' and patients' attitudes toward generic substitution and to increase neurologists' awareness of the issues.
The current federal and provincial regulations pertaining to generic drug approval and substitution are reviewed. Published anecdotal and survey reports of the effectiveness and tolerability of generic substitution for AEDs are reviewed. A pilot questionnaire survey of 83 patients from four adult epilepsy clinics and 46 neurologists from across Canada was undertaken to determine attitudes toward generic substitution.
Several authors have suggested that some AEDs, particularly those with a narrow therapeutic index, may pose problems with generic substitution. Although generic AEDs are lower in price, possible increased side effects and morbidity and the need for closer monitoring could partially offset the cost savings. The results of our survey highlight significant unawareness of the process of generic substitution among both patients and neurologists and reveal a general level of discomfort among neurologists to prescribe generic AEDs. Further data should be obtained about the potential consequences of generic substitution in epilepsy patients.
背景/目的：目前加拿大市场上有5种品牌抗癫痫药物（AEDs）的26种不同通用制剂，近期可能还会有其他产品上市。本综述的目的是探讨围绕品牌抗癫痫药物通用名替换争议的依据，呈现一项关于神经科医生和患者对通用名替换态度的调查结果，并提高神经科医生对这些问题的认识。
回顾当前联邦和省级有关通用药物批准和替换的法规。查阅已发表的关于AEDs通用名替换有效性和耐受性的轶事及调查报告。对来自四个成人癫痫诊所的83名患者和加拿大各地的46名神经科医生进行了一项初步问卷调查，以确定他们对通用名替换的态度。
几位作者指出，一些AEDs，尤其是治疗指数较窄的药物，可能在通用名替换方面存在问题。尽管通用名AEDs价格较低，但副作用和发病率可能增加以及需要更密切监测，可能会部分抵消成本节约。我们的调查结果凸显了患者和神经科医生对通用名替换过程的显著无知，并揭示了神经科医生在开具通用名AEDs时普遍存在的不适感。应获取更多关于癫痫患者通用名替换潜在后果的数据。
