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Tools for Advancing Pharmacy Practice
Point-of-care testing for infectious diseases: Opportunities, barriers, and considerations in community pharmacy
Paul O. Gubbins; Michael E. Klepser; Allison M. Dering-Anderson; Karri A. Bauer; Kristin M. Darin; Stephanie Klepser; Kathryn R. Matthias; Kimberly Scarsi
J Am Pharm Assoc (2003) 2014;54:163-171. doi:10.1331/JAPhA.2014.13167
View Author Identification Section
Paul O. Gubbins: Paul O. Gubbins, PharmD, FCCP, Professor and Associate Dean, University of Missouri–Kansas City School of Pharmacy at Missouri State University, Springfield
Michael E. Klepser: Michael E. Klepser, PharmD, FCCP, Professor, Department of Pharmacy Practice, College of Pharmacy, Ferris State University, Kalamazoo, MI
Allison M. Dering-Anderson: Allison M. Dering-Anderson, PharmD, Clinical Assistant Professor, Department of Pharmacy Practice, College of Pharmacy, University of Nebraska Medical Center, Omaha
Karri A. Bauer: Karri A. Bauer, PharmD, BCPS, Specialty Practice Pharmacist, Infectious Diseases, Ohio State University Medical Center, Columbus
Kristin M. Darin: Kristin M. Darin, PharmD, BCPS, Research Assistant Professor in Medicine–Infectious Diseases, Center for Global Health, Northwestern University Feinberg School of Medicine, Chicago, IL
Stephanie Klepser: Stephanie Klepser, PharmD, Director of Clinical Services, Kalamazoo Center for Medical Studies Pharmacy, Kalamazoo, MI
Kathryn R. Matthias: Kathryn R. Matthias, PharmD, BCPS (AQ-ID), Assistant Professor, Pharmacy Practice & Science, College of Pharmacy, University of Arizona, Tucson
Kimberly Scarsi: Kimberly Scarsi, PharmD, MS, BCPS, Associate Professor, Pharmacy Practice, College of Pharmacy, University of Nebraska Medical Center, Omaha

Abstract

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.

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