9/30/2018 1
9/30/2018 Making Point of Care Testing Work in Your Pharmacy NCPA 2018 Annual Convention Kevin Day, PharmD, Brandon C. Achor, PharmD, Staff Pharmacist Owner / Managing Partner Day’s Miami Heights Pharmacy Lackie Drug Store Disclosure Brandon Achor declares no conflicts of interest or financial interest in any product or service mentioned in this program, including grants, employment, gifts, stock holdings, and honoraria. Kevin Day declares no conflicts of interest or financial interest in any product or service mentioned in this program, including grants, employment, gifts, stock holdings, and honoraria. 2
9/30/2018 Learning Objectives • Discuss different point-of-care tests that require a CLIA waiver • Outline strategies for establishing collaborative practice agreements with local providers • Explain processes needed to implement POCT in your pharmacy Opportunity • Millions of influenza and acute pharyngitis cases each year • 76 million baby boomers should be screened for Hepatitis C • Estimated 162,500 undiagnosed HIV patients • 7 million undiagnosed diabetes patients • 7,500 urgent care centers across the country 3
9/30/2018 Overview of Pharmacy POCT • Infectious Disease Testing • Infectious Disease Screening • Chronic Disease Monitoring • Chronic Disease Screening Overview of Pharmacy POCT • Consumer Driven Healthcare • Pharmacists as Providers • Healthcare Destination 4
9/30/2018 Legal Considerations • CLIA • CMS Form 116 • You must be a CLIA Waived facility! • State Board of Pharmacy • Pharmacists or Technicians? Specifically Restricted? • Liability • Collaborative Practice Training • Requirements? Options? • Comfort Level • Protocols • Who is going to do what, when? • Documentation • What is going to be shared with whom, when? • Practice! 5
9/30/2018 Statistics Specificity • Higher this goes… fewer false positives. • Rapid Influenza Diagnostic Tests (RIDTs) are generally up to 95% and better (very good) Sensitivity • Higher this goes… fewer false negatives. • Rapid Influenza Diagnostic Tests (RIDTs) range from 50-70% (not all that great) Statistics – Positive Predictive Value If Influenza Prevalence is… And Specificity is… Then PPV is… False Pos. rate is… VERY LOW (2.5%) MODERATE (80%) VERY LOW (6-12%) VERY HIGH (88-94%) VERY LOW (2.5%) HIGH (98%) LOW (39-56%) HIGH (44-61%) MODERATE (20%) MODERATE (80%) LOW (38-56%) HIGH (44-62%) MODERATE (20%) HIGH (98%) HIGH (86-93%) LOW (7-14%) 6
9/30/2018 Statistics – Negative Predictive Value If Influenza Prevalence is… And Sensitivity is… Then NPV is… False Neg. rate is… MODERATE (20%) LOW (50%) MODERATE (86-89%) MODERATE (11-14%) MODERATE (20%) HIGH (90%) HIGH(97-99%) LOW (2-3%) HIGH (40%) LOW (50%) MODERATE (70-75%) MODERATE (25-30%) HIGH (40%) HIGH (90%) HIGH (93-94%) LOW (6-7%) Who is this guy and why is he up there? • Raised in Maumelle, AR • Uof A Fayetteville • Studied abroad in Dublin, Ireland because they said it would be free (it wasn’t) • UAMS College of Pharmacy Class of 2015 • 1 st Runner-Up in NCPA Business Plan Competition 2014 • Became co-owner of Lackie Drug Store in 2016 • Implemented POCT same year 7
9/30/2018 How I Got Started • Wholesaler Annual Tradeshow 2016 • CLIA Waiver and Device Training for All Employees • Meetings with Local Providers (for Marketing and Quality Assurance) • Marketed to Community and School System (good idea) • Waited for Storm to Hit • https://www.thv11.com/video/news/health/pharmacists-offering-flu- tests/91-2902755 8
9/30/2018 Workflow Integration Pharmacist is Patient is delivered directed to Patient Cashier Technician intake form designated requests receives administers and counsels testing area testing payment test patient while to fill out awaiting intake form results Literature Access to Care Patients visited Patients did not pharmacy have a primary 38% 54 % care provider outside normal clinic hours Klepser, D. G., et al. (2018). "Utilization of influenza and streptococcal pharyngitis point-of-care testing in the community pharmacy practice setting." Res Social Adm Pharm 14(4): 356-359. 9
9/30/2018 11-28% Patients screened for influenza test positive 16-25% Patients screened for streptococcus test positive 13 ± 3.0 Minutes of pharmacists’ time per encounter for strep screening Klepser, D. G., et al. (2018). Res Social Adm Pharm 14(4): 356-359. Kawachi, A., et al. (2017). J Pharm Health Care Sci 3: 22. Klepser, D. G., et al. (2016). J Am Pharm Assoc (2003) 56(3): 323-329 e321. Papastergiou, J., et al. (2018). J Am Pharm Assoc (2003). Corn, C. E., et al. (2017). J Pharm Pract (1531-1937): 897190017710518. Klepser, M. E., et al. (2016). J Am Pharm Assoc (2003) 56(1): 14-21. Investment • Initial Investment: • Device (free - $260) + 30 StrepTests (~$80) + 30 FluTests (~$350) = $430 – 690.00 • Break Even: #24 - 38 Flu Tests and/or #16 - 30 Strep Tests (assuming $30 fee) 10
9/30/2018 Questions? Brandon C. Achor, PharmD Owner / Managing Partner Lackie Drug Store lackiedrug@gmail.com Kevin Day, PharmD Staff Pharmacist Day’s Miami Heights Pharmacy kcday8@gmail.com 11
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