Barrett Megan Weigel
Baptist Neurology, Jacksonville Beach, Florida 32250, USA.
J Am Acad Nurse Pract. 2010 Jun;22(6):300-4. doi: 10.1111/j.1745-7599.2010.00511.x.
To educate prescribing clinicians about bioequivalent standards for therapeutic equivalence of brand and generic antiepileptic drugs (AEDs) as more generic drugs come to market, and to increase awareness of practice and safety issues surrounding the use of these drugs for people with seizures.
Information was gathered from a search of the scientific literature as well as the author's clinical experience.
Controversy exists regarding the therapeutic equivalence of brand and generic AEDs, even when bioequivalent standards are satisfied. Generic AEDs have been associated with breakthrough seizures and adverse events that may outweigh cost savings encouraged by third-party payors. Further research is needed comparing brand to generic drugs in a rigorous manner in order to make a consensus statement regarding the safety and equivalency of generic AEDs for all patient populations.
Generic AEDs may be safely prescribed in certain situations if clinicians are aware of ethical, legal, and practice issues surrounding their use. Sufficient time should be spent educating patients, caregivers, and pharmacists about implications of a switch made without the knowledge of the patient and/or prescriber.
随着越来越多的通用型抗癫痫药物（AEDs）上市，对开处方的临床医生进行关于品牌和通用型AEDs治疗等效性的生物等效性标准教育，并提高对这些药物用于癫痫患者时的实践和安全问题的认识。
信息收集自科学文献检索以及作者的临床经验。
即使满足生物等效性标准，品牌和通用型AEDs的治疗等效性仍存在争议。通用型AEDs与突破性癫痫发作和不良事件相关，这些不良事件可能超过第三方支付方所鼓励的成本节约。需要进行更严格的品牌药与通用型药物的比较研究，以便就通用型AEDs对所有患者群体的安全性和等效性达成共识声明。
如果临床医生了解围绕通用型AEDs使用的伦理、法律和实践问题，在某些情况下可以安全地开具通用型AEDs。应花费足够的时间对患者、护理人员和药剂师进行教育，使其了解在患者和/或开处方者不知情的情况下换药的影响。
