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Point of Care Testing & Policy Issues NABP Region V – August 2014
University of Nebraska Medical Center
Community Pharmacy-Based Point-of-Care Testing
University of Nebraska Medical Center
University of Nebraska College of Pharmacy
Donald Klepser, PhD, MBA
Associate Professor
Department of Pharmacy Practice
Ally Dering-Anderson, PharmD
Clinical Assistant Professor
Department of Pharmacy Practice
Why here and why now?
CLIA-waived testing
Dispensing per protocol
Statutory and Regulatory Challenges
“Heads Up” on the issues soon to come before
your boards
University of Nebraska Medical Center
The History of our research projects
Dr. Michael Klepser, PharmD, FACCP
Ferris State University College of Pharmacy
Meeting with Federal officials
Pandemic influenza response
Patient access to care
Time to first dose
University of Nebraska Medical Center
Solving Patient Access & Provider
Shortage Problems:
33% of Americans live within 10 minutes of a retail
healthcare clinic. (Convenient Care Association 2014)
92% of Americans live within 1.6 miles of a
pharmacy. (National Association of Chain Drug Stores 2013)
You would have to drive less than 8.7 miles per hour to be closer to the
retail healthcare clinic.
University of Nebraska Medical Center
Time to 1st dose Study
Could community pharmacy testing improve
time to first dose?
Sponsored by Gilead
11 Pharmacies in 4 States (MI, ID, TX, IL)
Used CLIA waived tests
Followed up with cultures
Communicated with providers for prescriptions
University of Nebraska Medical Center
Oops was this legal??
University of Nebraska Medical Center
CLIA-waived Testing
Urinalysis
Pregnancy – urine
Fecal occult blood
Blood glucose
Hemoglobin
Ovulation – urine
EtOH in saliva
Whole blood – Chem8,
LFT, Li, BUN, lipids, etc
Illicit drugs
Prescription drugs
opiates, benzos, secobarbital
Sperm motility
University of Nebraska Medical Center
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/analyteswaived.cfm
Infectious Diseases and CLIA-waiver
Vaginal pH & volatile amines
Mononucleosis
(heterophile antibodies)
H. pylori
Borrelia burgdorferi
Influenza
RSV
Group A Streptococcus
Screening Tools
HIV
Hepatitis C
University of Nebraska Medical Center
Lessons learned from early work
University of Nebraska Medical Center
Would anyone only
provide a service in
case of emergency?
Sustainability
Good patient care must be sustainable
University of Nebraska Medical Center
Complete Care
Testing without treatment is not the answer
This is about customer service and patient care
Dispensing per protocol, standing order, or
collaborative practice agreement
University of Nebraska Medical Center
10th Amendment
With 50 States and Washington DC, there are
51 ways to regulate this practice!
University of Nebraska Medical Center
If these pharmacies are CLIA-waived
laboratories, they are subject to
inspection
Opportunity for Board revenue??
University of Nebraska Medical Center
Research Completed
There have been a number of demonstration
projects showing:
1. The capacity of the pharmacists
2. The acceptance of the patient
University of Nebraska Medical Center
Research Completed
Influenza test & treat: we just finished
1. Collaborative
2. 55 pharmacies in 3 states (MI, MN, NE)
3. 121 patients screened, 78 tested, 7 treated
4. ~90% Patient Satisfaction
University of Nebraska Medical Center
Research Challenges
IRB Approval Process
Consenting Patients
Not everyone could wait for the results
1. FOIA Requests – are your researchers
protected?
University of Nebraska Medical Center
On-going Research
Group A Streptococcus test & treat
1. Similar to influenza study, but bigger numbers
2. Anti-microbial resistance
Public Health Experts & Focus Groups
1. At least 7 states (MN, NE, ID, WA, OR, MI, MD)
2. Building partnerships and improving care
University of Nebraska Medical Center
Future Research
Infection control and patient segregation in
Community Pharmacies
POC testing for chronic disease management
Hemoglobin A1c
Potassium levels
State Law Comparisons
University of Nebraska Medical Center
Interesting Comments and Concerns
Are Pharmacists Trained to do this?
What about the Diagnostician-Patient
relationship?
Is this Diagnosing?
University of Nebraska Medical Center
More Comments and Concerns
Dr. Oz
Public Health Experts:
Pharmacists report “Clean Data”
Immunization rates suck – pharmacy can
help
University of Nebraska Medical Center
The Future
University of Nebraska Medical Center
Future Issues to Consider
Collaboration is essential under the ACA
Restrictive or Descriptive Laws and
Regulations will always be a challenge
“Fee splitting” prohibitions need to be redefined
or eliminated
Expanded role for pharmacists means
expanded duties for technicians
University of Nebraska Medical Center
Additional Resources
Available for Printing with the handouts:
Implementation and Evaluation of an Innovative
Pharmacist-Physician Collaborative
Influenza & Group A Streptococcal
Pharyngitis Management Program
“The Perfect Pharmacist Collaborative Practice
Protocol” courtesy of NACCHO
University of Nebraska Medical Center
University of Nebraska Medical Center University of Nebraska Medical Center