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503A 配制药房的认证、认可和资质认定。

Certification, Accreditation, and Credentialing for 503A Compounding Pharmacies.

作者信息

Pritchett Jon, McCrory Gary, Kraemer Cheri, Jensen Brenda, Allen Loyd V

机构信息

Accreditation Commission for Health Care, Inc., Cary, North Carolina.

PersonalMed, Houston, Texas.

出版信息

Int J Pharm Compd. 2018 Jan-Feb;22(1):7-16.

Abstract

The terms certification, accreditation, and credentialing are often used interchangeably when they apply to compounding-pharmacy qualifications, but they are not synonymous. The reasons for obtaining each, the requirements for each, and the benefits of each differ. Achieving such distinctions can negatively or positively affect the status of a pharmacy among peers and prescribers as well as a pharmacy's relationships with third-party payors. Changes in the third-party payor industry evolve constantly and, we suggest, will continue to do so. Compounding pharmacists must be aware of those changes to help ensure success in a highly competitive marketplace. To our knowledge at the time of this writing, there is no certification program for compounding pharmacists, although pharmacy technicians can achieve certification and may be required to do so by the state in which they practice (a topic beyond the scope of this article). For that reason, we primarily address accreditation and credentialing for 503A compounding pharmacies. In this article, the evolution of the third-party payment system for compounds is reviewed; the definitions of certification, accreditation, and credentialing are examined; and the benefits and recognition of obtaining accredited or credentialed status are discussed. Suggestions for selecting an appropriate agency that offers accreditation or credentialing, preparing for and undergoing an onsite survey, responding to findings, and maintaining a pharmacy practice that enables a successful survey outcome are presented. The personal experience of author CK during accreditation and credentialing is discussed, as is the role of a consultant (author BJ) in helping compounders prepare for the survey process. A list of agencies that offer accreditation and credentialing for compounding pharmacies is included for easy reference.

摘要

当涉及到配制药房资质时,“认证”“认可”和“资格认定”这几个术语经常被互换使用,但它们并非同义词。获取每种资质的原因、每种资质的要求以及每种资质的益处都有所不同。明确这些区别可能会对药房在同行和开处方者中的地位以及药房与第三方付款方的关系产生消极或积极的影响。第三方付款方行业的变化不断演进,我们认为这种情况还将持续。配制药剂师必须了解这些变化,以助力确保在竞争激烈的市场中取得成功。据我们撰写本文时所知,目前尚无针对配制药剂师的认证项目,不过药房技术员可以获得认证,并且所在州可能要求他们这样做(这一话题超出了本文范围)。因此,我们主要探讨503A配制药房的认可和资格认定。本文回顾了化合物第三方支付系统的演变;审视了认证、认可和资格认定的定义;讨论了获得认可或资格认定状态的益处和认可度。还提出了选择合适的提供认可或资格认定的机构、为现场检查做准备并接受检查、对检查结果做出回应以及维持能使检查成功通过的药房业务的建议。文中讨论了作者CK在认可和资格认定过程中的个人经历,以及顾问(作者BJ)在帮助配制人员准备检查过程中所起的作用。还列出了为配制药房提供认可和资格认定的机构名单,以便查阅。

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