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