Papsdorf Tania Beltran, Ablah Elizabeth, Ram Surya, Sadler Toni, Liow Kore
University of Kansas School of Medicine-Wichita, Wichita, KS 67214-3199, USA.
Epilepsy Behav. 2009 Jan;14(1):150-3. doi: 10.1016/j.yebeh.2008.09.009. Epub 2008 Oct 30.
Concerns have been raised about the safety of switching from a branded antiepileptic drug (AED) to a generic AED. The goal of the study described here was to understand patients' experiences with generic AEDs in the Midwestern United States.
A one-page, six-item survey was mailed to 356 patients to determine patients' awareness of the existence and their usage of generic AEDs.
Twenty-eight percent (27.8%) of respondents (N=179) reported breakthrough seizures they believed were a direct result of the switch from a brand to a generic AED, and 33.7% reported side effects due to the switch. Thirty-one percent (31.2%) returned to a brand-name AED as a result. Sixty-nine percent (68.8%) reported being unaware that some pharmacies switch to generic AEDs without a patient's or physician's consent, and 78.7% expressed concern over this.
A significant percentage of patients reported that generic AEDs were responsible for breakthrough seizures and increased side effects. A significant percentage of patients also reported switching back to a brand-name AED and expressed concern over pharmacies switching to generic AEDs without a patient's or physician's consent.
从品牌抗癫痫药物(AED)转换为通用型AED的安全性已引发关注。此处所述研究的目标是了解美国中西部地区患者使用通用型AED的经历。
向356名患者邮寄了一份包含6个条目的单页调查问卷,以确定患者对通用型AED的存在及其使用情况的知晓程度。
28%(27.8%)的受访者(N = 179)报告称,他们认为突破性癫痫发作是从品牌药转换为通用型AED的直接结果,33.7%的受访者报告因转换而出现副作用。31%(31.2%)的受访者因此重新使用品牌名AED。69%(68.8%)的受访者报告称,他们不知道有些药店在未经患者或医生同意的情况下就转换为通用型AED,78.7%的受访者对此表示担忧。
相当比例的患者报告称,通用型AED导致了突破性癫痫发作和副作用增加。相当比例的患者还报告称重新使用品牌名AED,并对药店在未经患者或医生同意的情况下转换为通用型AED表示担忧。