Expanding Access through Pharmacy-Based Point-of-Care Testing

Transcription

1 Expanding Access through Pharmacy-Based Point-of-Care Testing Donald G. Klepser, PhD Associate Professor, Department of Pharmacy Practice University of Nebraska Medical Center Doug Read, Pharm.D. Director, Pharmacy Compliance and Regulatory Affairs H-E-B

2 Learning Objectives Identify examples of point-of-care tests that may be used in community pharmacy settings. Describe ways to implement point-of-care testing in community pharmacy settings and the need for a CLIA-waiver. Identify current challenges with implementing point-of-care testing in the pharmacy.

3 Disclosures Donald G. Klepser - Consultant - Michigan Pharmacists Association and Cannon, Principal Investigator - NACDS Foundation Grant Doug Read none This presentation is intended for educational use only. Nothing in this presentation should be construed as an endorsement of any particular product or service, and all discussions are subject to the NACDS Antitrust Compliance Policy. Review of specific laws or regulations should not be construed as legal advice.

4 Expanding Access Through Pharmacy-Based Point-of-Care Testing Donald Klepser, PhD, MBA Associate Professor University of Nebraska Medical Center

5 Healthcare Environmental Scan A patient-centered collaborative care team approach becomes increasing relevant as: U.S. healthcare system continues on its transformational path Consumers desire more affordable and accessible innovative care models The public requires more access to acute care and prevention A nationwide primary care shortage creates burdens on access.

6 >120 CLIA-Waived Tests in U.S. Chronic Blood glucose Fecal occult blood Pregnancy Cholesterol Triglycerides Thyroid Stimulating Hormones Hemoglobin A1C HIV Hepatitis C Acute Influenza Group A Streptococcus Respiratory Syncytial Virus Mononucleosis H. Pylori

7 >120 CLIA-Waived Tests in U.S. Chronic Blood glucose Fecal occult blood Pregnancy Cholesterol Triglycerides Thyroid Stimulating Hormones Hemoglobin A1C HIV Hepatitis C Acute Influenza Group A Streptococcus Respiratory Syncytial Virus Mononucleosis H. Pylori

8 Model for Acute Conditions Patient Assessment Point of Care Test Action Enabled by Broad CPA Improved Health Outcomes

9 Model for Acute Conditions Patient Assessment Point of Care Test Action Enabled by Broad CPA Improved Health Outcomes The test is just a single piece of the puzzle. The value is the comprehensive pharmacy service enabled by a Collaborative Practice Agreement.

10 The role of POC testing for infectious diseases in community pharmacies Accessibility Complete disease management in the pharmacy Influenza and group A streptococcus (GAS) Screening HIV and Hepatitis C (HCV) Reduced antimicrobial resistance

11 Research Required Clinical outcomes Workflow Patient satisfaction & experience with care Collaboration and public health

12 Experience from Regional Chains Prospective study of Influenza and Group A Strep (GAS) testing and treatment 56 pharmacies from 5 regional chains in three states (MI, MN, NE) Trained all pharmacists (20 hour certificate program) Developed Algorithms from clinical guidelines (inclusion and exclusion criteria, clinical thresholds) Template state specific collaborative practice agreements, Workflow (data collection instruments and scripts)

13 Experience from Regional Chains Patients with a positive test were offered prescription Patients with negative test were counseled and provided OTC options All patients tested had a follow up call from the pharmacist hours after their visit Visit results were shared with the patient, their primary care provider, if possible, and the collaborating physician

14 Clinical Studies Influenza Results 121 patients screened 46 (38%) excluded from participation 75 (62%) tested, with 8 (11%) positive results Of positive results, 6 (75%) treated 59 (79%) of patients were reached for follow-up with hours 6 patients sought additional care (4 were referred by pharmacist) 35% of patients had no primary care provider 39% of patients were seen outside of normal clinic hours Klepser, et al. Clinical Infectious Disease. (Submitted)

15 Workflow Considerations Initial patient assessment Pharmacist collects illness history, runs test, and obtains vitals Positive test Rx processed Negative test OTC assistance Follow-up protocol Inform PCP

16 Workflow Time and Motion Studies Conducted in June 2013 (influenza 1 ) and July 2014 (GAS) Standardized patient presented to pharmacies with signs and symptoms consistent with disease of interest Researcher recorded time for the overall encounter and for each of 9 steps Time for each step was classified as pharmacist time, pharmacy technician time, or as patient waiting time Klepser DG, et al. Innovations in Pharmacy. 2014;5:1-8.

17 Workflow Time and Motion Studies Overall encounter time of 35.5 minutes Active pharmacist engagement 9.4 minutes When technicians played a larger role in data collection and physical assessment, active pharmacist engagement fell to 4.95 minutes Klepser DG, et al. Innovations in Pharmacy. 2014;5:1-8.

18 Patient Satisfaction Satisfied with how illness was treated at the pharmacy Would go back to the pharmacy for a similar illness in the future Are comfortable being treated by my pharmacist for illnesses like the flu Strongly Agree/Agr ee 86% 82% 96% Klepser DG, et al. National Rural Health Association. 2014

19 Public Health Focus Groups Partnered with National Association of County and City Health Officials (NACCHO) to conduct focus groups with public health officials in 7 states (ID, MD, MI, MN, NE, OR, WA) Supportive of POCT testing in pharmacies as long as high quality training is provided, collaborative protocols are followed, and appropriate reporting takes place Generated several concrete collaborations and future opportunities MN: reporting of flu results to state health dep t ID: sending swabs to state lab for cultures

20 Surveillance Patient De-identified Cloud #1 Cloud #2 Public Health Pharmacy

21 Training and Toolkits Community Pharmacy-Based Point-of-Care Testing Certificate Program managed by NACDS ( Upon completion of program, pharmacists have access to all materials needed to develop a POC testing service

22 Practical Considerations Initial resistance from medical community created opportunity to refer the 35% of patients with no PCP State-level restrictions on Collaborative Practice Agreements need to be broad and not tied to individual patients

23 Envisioning the Future Patient Assessment Point of Care Test Action Enabled by Broad CPA Improved Health Outcomes Chronic Blood glucose Fecal occult blood Cholesterol Triglycerides Thyroid Stimulating Hormones Hemoglobin A1C HIV Hepatitis C Acute Influenza Group A Streptococcus Respiratory Syncytial Virus Mononucleosis H. Pylori

24 Community Pharmacy and Point-of-Care Testing NACDS Regional Chain Conference February 3, 2015 Doug Read, Pharm.D. HEB Pharmacy

25 Why PHARMACY? Accessibility 3 rd Largest Healthcare Workforce in United States Role transition Complexity of medications Shortages in primary care outlets

26 U.S. Preventive Services Task Force Grade Definition Suggestions for Practice A The USPSTF recommends the service. There is high Offer or provide this service. certainty that the net benefit is substantial. B The USPSTF recommends the service. There is high Offer or provide this service. certainty that the net benefit is moderate or there is moderate certainty that the net benefit is moderate to substantial. C The USPSTF recommends selectively offering or providing this service to individual patients based on Offer or provide this service for selected patients depending on individual circumstances. professional judgment and patient preferences. There is at least moderate certainty that the net benefit is small. D The USPSTF recommends against the service. There is Discourage the use of this service. moderate or high certainty that the service has no net benefit or that the harms outweigh the benefits. I Statement The USPSTF concludes that the current evidence is Read the clinical considerations section of USPSTF insufficient to assess the balance of benefits and harms of Recommendation Statement. If the service is offered, the service. Evidence is lacking, of poor quality, or patients should understand the uncertainty about the conflicting, and the balance of benefits and harms cannot balance of benefits and harms. be determined.

27 USPSTF A and B rated recommendations significant to pharmacy Blood Pressure Cholesterol Diabetes Blood Pressure Osteoporosis Obesity

28 OTHERS HIV Colorectal Cancer STD Tobacco Use Counseling and Interventions

29 Legal/Regulatory Considerations CLIA CMS regulates all laboratory testing performed on humans (except research) in the U.S. through the CLIA Ensures quality laboratory testing Must be certified to receive Medicare/Medicaid reimbursements

30 Legal/Regulatory Considerations CLIA Types of Tests WAIVED*** Moderate-Complexity (non-waived) High-Complexity (non-waived)

31 Legal/Regulatory Considerations CMS 116 form at

32 Legal/Regulatory Considerations CLIA WAIVER REQUIREMENTS Based upon complexity of testing Waived tests described as simple laboratory examinations and procedures which have an insignificant risk of an erroneous result. SOURCE: Typically ordered by an individual without a prior consultation with a physician or a physician request for testing

33 Legal/Regulatory Considerations CLIA-WAIVED LAB REQUIREMENTS Designated LAB Director No routine inspections, but can occur Follow manufacturer s guidelines Develop Policies and Procedures Employee Training Quality Assurance and Record-Keeping

34 Legal/Regulatory Considerations PRIVACY Physical Considerations Record-Keeping and Security of Records OSHA Training-Bloodborne Pathogens Post-Exposure Protocol Use of P.P.E. Waste Disposal Hep B Vaccine Exposure Documentation Review of new devices

35 Sustainability Which comes first? Outcomes OR Reimbursement?

36 Sustainability Payers want data Start with own employees Engage local businesses Local/regional health plans Emphasize STRENGTHS

37 H-E-B Second Saturday Screenings Program launched in 2008 Initially ran March-October Expanded to year-round in 2011 All RX locations screen on 2 nd Saturday of each month Screeners are RX Technicians and RX Care Reps (clerks) Training received through internal H-E-B screener certification Some stores offer additional in-store screening days Professional Services

38 H-E-B Second Saturday Screenings Blood Pressure (FREE) Blood Glucose (FREE) Total Cholesterol (DISCOUNTED) HDL/LDL/Triglycerides (DISCOUNTED) A1C (FREE for customers with fasting glucose >100, DISCOUNTED for others)

39 H-E-B Second Saturday Screenings Since inception in 2008, H-E-B has screened well over 1,000,000 patients H-E-B Partner Screenings SUCCESS STORIES My husband refused to go to the doctor for years. His blood pressure reading at your event concerned him so much he has an appointment next week. Customers frequently bring their friends and family members to screening events after experiencing it themselves

40 H-E-B Second Saturday Screenings Group Worksite Health Screenings Partner with large employers and wellness groups Annual health screenings Coupled with flu/immunization clinics Complement to employee weight-loss programs Participate in insurance open enrollment fairs

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