Point-of-care testing for infectious diseases: Opportunities, barriers, and considerations in community pharmacy
Point-of-care testing for infectious diseases: Opportunities, barriers, and considerations in community pharmacy
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DOI：
10.1331/japha.2014.13167
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发表时间：
2014-03-01
影响因子：
2.1
通讯作者：
Scarsi, Kimberly
中科院分区：
文献类型：
--
作者：
Gubbins, Paul O.;Klepser, Michael E.;Scarsi, Kimberly
目标：确定在社区药房进行护理点检测（POC）和/或传染病筛查的机会，概述此类检测及其在当前实践中的使用情况，讨论1988年临床实验室改进修正案（CLIA）对药剂师进行POC检测的影响，并确定和讨论障碍，并为那些希望在社区药房建立传染病服务的POC检测提供建议。数据来源：本文的叙述性综述部分从2012年11月至2013年5月检索PubMed和谷歌Scholar，检索词为快速诊断测试、POC测试和传染病、药房服务、CLIA豁免和协同药物治疗管理，检索时间为2000年及以后。2012年和2013年1月，我们联系了美国所有州的药事会，并访问了他们的监管和立法网站，以审查相关的药学实践法律。数据综合：传染病POC检测是扩大社区药房服务的重要机会。药剂师教育和培训正在解决良好实验室规范和测试表现和解释方面的知识缺陷。联邦法规并没有明确规定那些执行clia豁免测试的人的资格，但很少有药剂师提供此类服务。不到20%的州在其管理药房的法规和条例中涉及POC检测。结论：传染病POC检测有利于患者和社会，为社区药房扩大药学服务提供了契机。在社区药房实施这类服务的现有障碍，包括药剂师培训和教育方面的缺陷，以及各州监管和立法的差异以及管理药房的法规的模糊，并非不可克服。
Objectives: To identify opportunities to perform point-of-care (POC) testing and/or screening for infectious diseases in community pharmacies, provide an overview of such tests and how they are used in current practice, discuss how the Clinical Laboratory Improvement Amendments of 1988 (CLIA) affect pharmacists performing POC testing, and identify and discuss barriers and provide recommendations for those wanting to establish POC testing for infectious diseases services in community pharmacies.Data sources: PubMed and Google Scholar were searched from November 2012 through May 2013 and encompassed the years 2000 and beyond for the narrative review section of this article using the search terms rapid diagnostic tests, POC testing and infectious diseases, pharmacy services, CLIA waiver, and collaborative drug therapy management. All state boards of pharmacy in the United States were contacted and their regulatory and legislative websites accessed in 2012 and January 2013 to review relevant pharmacy practice laws.Data synthesis: POC testing for infectious diseases represents a significant opportunity to expand services in community pharmacies. Pharmacist education and training are addressing knowledge deficits in good laboratory practices and test performance and interpretation. Federal regulations do not define the qualifications for those who perform CLIA-waived tests, yet few pharmacists perform such services. Fewer than 20% of states address POC testing in their statutes and regulations governing pharmacy.Conclusion: POC testing for infectious diseases could benefit patients and society and represents an opportunity to expand pharmacy services in community pharmacies. Existing barriers to the implementation of such services in community pharmacies, including deficits in pharmacist training and education along with state regulatory and legislative variance and vagueness in statutes governing pharmacy, are not insurmountable.