Manolakis Patti Gasdek
PMM Consulting, Charlotte, NC, USA.
J Am Pharm Assoc (2003). 2007 May-Jun;47(3):328-38. doi: 10.1331/JAPhA.2007.07502.
To generate patient-centered, evidence-based decision support tools and compile resources that will assist pharmacists in prescription drug product substitution activities and related communication, and to present the resulting tools and resources.
Food and Drug Administration (FDA) publications, data, and communication; peer-reviewed literature; interviews with pharmacists; structured discussions with members of the project Advisory Board; and author's own knowledge and records of events.
A decision whether to substitute an alternative product for a prescribed medication is a clinically based process that must be grounded in appropriate medical evidence, therapeutic equivalence information, financial factors, and consideration of how the substitution will impact the patient. Product substitution decisions are influenced by therapeutic issues, legal matters, patient-centered concerns, and pharmacy practice factors, including work flow, supply issues, access to current resources, and misperceptions about database information. While generic substitution is clearly defined in many cases, some medication categories require special consideration, i.e., critical dose and narrow therapeutic index drugs, products with special release mechanisms, bioengineered protein products, many hormonal products, older drugs marketed before 1938 that were not subject to FDA approval, and others with limited bioequivalence data. In response to reports of the challenges pharmacists face when determining the appropriateness of product substitution and in support of their interdisciplinary efforts to improve medication use, the American Pharmacists Association (APhA) convened an advisory board to create the decision support tool featured in this article.
The U.S. health care system and patients rely on pharmacists as medication use experts to ensure that prescription drug product substitutions are appropriate. Pharmacists must be able to efficiently determine therapeutic equivalence, identify situations where further research is required, have access to timely resources for gathering information, and effectively communicate with patients and physicians about substitution issues. The prescription drug product substitution tool and related resources presented are intended to assist pharmacists in making and communicating clinically sound product substitution decisions that are patient centered, evidence based, consistent with state and federal laws and regulations, and reflective of the realities of health care today.
生成以患者为中心、基于证据的决策支持工具，并汇编有助于药剂师进行处方药产品替换活动及相关沟通的资源，同时展示所得出的工具和资源。
美国食品药品监督管理局（FDA）的出版物、数据及通讯；同行评审文献；对药剂师的访谈；与项目咨询委员会成员的结构化讨论；以及作者自身的知识和事件记录。
决定是否用替代产品替换处方药物是一个基于临床的过程，必须以适当的医学证据、治疗等效性信息、财务因素以及对替换将如何影响患者的考虑为基础。产品替换决策受到治疗问题、法律事项、以患者为中心的关注以及药学实践因素的影响，包括工作流程、供应问题、获取当前资源的途径以及对数据库信息的误解。虽然在许多情况下通用名替换有明确规定，但某些药物类别需要特殊考虑，即临界剂量和窄治疗指数药物、具有特殊释放机制的产品、生物工程蛋白产品、许多激素类产品、1938年以前上市且未经过FDA批准的旧药，以及其他生物等效性数据有限的药物。为应对有关药剂师在确定产品替换的适宜性时所面临挑战的报告，并支持他们为改善药物使用而开展的跨学科努力，美国药剂师协会（APhA）召集了一个咨询委员会来创建本文所介绍的决策支持工具。
美国医疗保健系统和患者依赖药剂师作为药物使用专家，以确保处方药产品替换是恰当的。药剂师必须能够有效地确定治疗等效性，识别需要进一步研究的情况，获取及时的信息收集资源，并就替换问题与患者和医生进行有效沟通。所展示的处方药产品替换工具及相关资源旨在帮助药剂师做出并传达以患者为中心、基于证据、符合州和联邦法律法规且反映当今医疗保健实际情况的临床合理产品替换决策。
