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合理使用非专利精神药物。

Rational use of generic psychotropic drugs.

机构信息

The Zucker Hillside Hospital, Division of Psychiatry Research, 75-59 263rd Street Glen Oaks, New York, NY 11004, USA.

出版信息

CNS Drugs. 2013 May;27(5):353-65. doi: 10.1007/s40263-013-0045-2.

Abstract

For economic reasons, the generic substitution of branded medications is common and welcome. These replacements are based on the concept of bioequivalence, which is considered equal to therapeutic equivalence. Regulatory standards for bioequivalence require the 90 % confidence intervals of group averages of pharmacokinetic measures of a generic and the original drug to overlap within ±20 %. However, therapeutic equivalence has been challenged for several psychotropic agents by retrospective studies and case reports. To evaluate the degree of bioequivalence and therapeutic equivalence of branded and generic psychotropic drugs, we performed an electronic search (from database inception until 24 May 2012 and without language restrictions) in PubMed/MEDLINE, Cochrane Library, and Web of Science. Search terms were "(generic) AND (psychotropic OR psychoactive OR antipsychotic OR antiepileptic OR antidepressant OR stimulant OR benzodiazepine)" or the respective individual substances. We included clinical studies, regardless of design, comparing branded with generic psychotropic drug formulations, identifying 35 such studies. We also included case reports/series reporting on outcomes after a switch between brand and generic psychotropics, identifying 145 clinical cases. Bioequivalence studies in healthy controls or animals, in-vitro studies, and health economics studies without medical information were excluded. An overview of the few randomized controlled studies supports that US FDA regulations assure clinically adequate drug delivery in the majority of patients switched from brand to generic. However, with a growing number of competing generic products for one substance, and growing economic pressure to substitute with the currently cheapest generic, frequent generic-generic switches, often unbeknownst to prescribing clinicians, raise concerns, particularly for antiepileptics/mood stabilizers. Generic-generic switches may vary by more than ±20 % from each other in individual patients since the pharmacokinetic properties of each generic may differ from the innovator drug in opposing directions. Ideally, therapeutic equivalence studies in addition to pharmacokinetic equivalence studies would be performed for each generic, reflecting the full variability of clinical responses due to changes of pharmacokinetic properties related to age, sex, ethnicity, genetic factors, and body mass index. This is particularly relevant, as bioequivalence studies are based on single-dose studies in healthy controls who are likely not representative of the patients who are prescribed the psychotropic medications. Additionally, individual case reports suggest potential clinical effects during brand-generic switches. Knowledge and consideration of intra-individual variations can help guide the clinical management during brand-generic or generic-generic switch periods. To optimize outcomes, clinicians need to consider that when using generic psychotropic medications, a change in the patient's clinical status can be related to psychological, interactional, physiological, and pharmacological factors that may or may not be related to the change to a generic drug. In addition, throughout all treatment periods, clinicians need to be aware of the currently dispensed product (i.e., branded or exact generic formulation), particularly when evaluating clinical changes in efficacy, tolerability, and adherence. If clinical problems occur, the first response should be an assessment of adherence and a careful dose adjustments of the generic drug rather than an immediate switch back to the originator.

摘要

出于经济原因,品牌药物的通用替代物很常见且受到欢迎。这些替代品基于生物等效性的概念,被认为与治疗等效性相等。生物等效性的监管标准要求通用药物和原药的群体平均值的药代动力学测量的 90%置信区间在±20%内重叠。然而,一些精神药物的治疗等效性受到回顾性研究和病例报告的挑战。为了评估品牌和通用精神药物的生物等效性和治疗等效性,我们在 PubMed/MEDLINE、Cochrane 图书馆和 Web of Science 中进行了电子搜索(从数据库创建开始到 2012 年 5 月 24 日,且没有语言限制)。搜索词为“(generic) AND (psychotropic OR psychoactive OR antipsychotic OR antiepileptic OR antidepressant OR stimulant OR benzodiazepine)”或各自的单个物质。我们纳入了比较品牌和通用精神药物制剂的临床研究,无论设计如何,共确定了 35 项此类研究。我们还纳入了报告品牌和通用精神药物转换后结局的病例报告/系列,共确定了 145 例临床病例。排除了健康对照或动物中的生物等效性研究、体外研究和没有医疗信息的健康经济学研究。少数随机对照研究的概述支持美国 FDA 法规在大多数从品牌转换为通用药物的患者中确保了临床足够的药物输送。然而,随着一种物质的竞争通用产品数量的增加,以及出于经济压力而用目前最便宜的通用产品替代,经常在开处方的临床医生不知情的情况下进行通用-通用转换,这引起了关注,特别是对于抗癫痫药/情绪稳定剂。由于每个通用产品的药代动力学特性可能与创新药物相反,因此在个体患者中,通用-通用转换可能彼此相差超过±20%。理想情况下,对于每个通用产品,除了药代动力学等效性研究外,还应进行治疗等效性研究,以反映由于与年龄、性别、种族、遗传因素和体重指数相关的药代动力学特性变化而导致的临床反应的全部可变性。这一点尤其重要,因为生物等效性研究基于健康对照者的单剂量研究,而健康对照者不太可能代表开出精神药物的患者。此外,个别病例报告表明在品牌-通用转换期间可能存在潜在的临床影响。对个体内变异的了解和考虑有助于指导品牌-通用或通用-通用转换期间的临床管理。为了优化结果,临床医生需要考虑到,在使用通用精神药物时,患者临床状况的变化可能与心理、相互作用、生理和药理学因素有关,这些因素可能与药物转换有关,也可能无关。此外,在所有治疗期间,临床医生都需要了解当前配给的产品(即品牌或确切的通用制剂),特别是在评估疗效、耐受性和依从性方面的临床变化时。如果出现临床问题,第一反应应该是评估依从性并仔细调整通用药物的剂量,而不是立即转回原药。

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