One-Step PrEP: A pharmacist-run HIV pre- exposure prophylaxis (PrEP… · 2017-05-10 · One-Step PrEP • Created in March 2015 • Physician Medical Director • Protocol and collaborative

This presentation is intended for educational use only, and does not in any way constitute medical consultation or advice

related to any specific patient.

Mountain West AIDS Education and Training Center

One-Step PrEP: A pharmacist-run HIV pre-

exposure prophylaxis (PrEP) clinic in a

community pharmacy setting. Elyse L. Tung, PharmD, BCACP

Annalisa Z. Thomas, PharmD

Peter Shalit, MD, PhD, FACP, AAHIVS

NW AETC ECHO May 4, 2017

Objectives

• Review clinic operations

• Discuss program requirements

• Review clinic data

Clinic Operations

One-Step PrEP

• Created in March 2015

• Physician Medical Director

• Protocol and collaborative drug therapy agreement

developed as outlined by the 2014 PrEP Guidelines

• Allows the pharmacist to provide:

• All initial screening, counseling, prescribing and

dispensing

• All billing and assistance

• All routine follow up care

• All STI testing & treatment

State Legislation

Licensing Requirements

PROGRAM REQUIREMENTS

Barriers to Overcome

Program Requirements

• Pharmacists scope of practice to prescribe and order labs

• Billing for services

• Obtaining labs

State Legislation

Program Requirements

• Collaborative Drug Therapy Agreement:

- State RCW 18.64.011 (23): “Practice of pharmacy includes. . . the

initiating or modifying of drug therapy in accordance with written

guidelines or protocols previously established and approved for his or

her practice by a practitioner authorized to prescribe drugs.”

• Billing for Services:

- Patient responsibility

- Alternatively, WA State Senate Bill 5557 – Landmark provider status

legislation that requires health insurance carriers to recognize

pharmacists as providers and allow for billing.

Licensing Requirements

Program Requirements

• Medical Test Site Certificate of Waiver License

(CLIA-waiver)

– Dedicated patient space

– Dedicated lab processing space

• Phlebotomy license:

– State specific training and licensing requirements

– Not included in pharmacist scope of practice

CLINIC DATA

Results

Clinic Data

• March 2015 – March 2016

• Patients seeking service:

373

– Evaluated in clinic: 251

– Initiated PrEP: 245

– Existing Primary Care

Provider: 57

Patient Characteristics 245

Sex/gender – no. (%)

Male 241 (98)

Female 4 (1.6)

Transgender man 2 (1)

Age group – no. (%)

mean 34 yr

range 18 – 64 yr

Sexual risk factors at screening – no.

(%)

MSM 210

(84%)

MSM index* – avg. 20 + 7.2

Bisexual 10 (4%)

Known HIV positive partner 69 (28%)

Injection drug user 2 (0.8%)

Results

Clinic Data

Clinic Discoveries During First Year of

Operation

STI’s diagnosed – no. 26

Chlamydia – no. (%) 12 (46)

Gonorrhea – no. (%) 9 (35)

Syphilis – no. (%) 4 (15)

Hepatitis B positive screen 1 (4)

HIV – no. (%)

Positive at initial screening 1 (0)

Positive at routine follow up 1 (0)

Patients connected to a primary

care provider – no. (%)

101 (40)

Clinic Discoveries During First Year of

Operation

Clinic Retention

Retention rate 75%

Discontinued service - no. (%) 63 (25)

Insurance restriction or

transfer of care

38

Lost to follow up 13

Decreased risk perception 7

Relocation 5

Patients paying $0 per month for

medication – no. (%)

235 (97)

Time to operation costs are self

sustainable - months

8.4

Conclusion

• One-Step PrEP® is feasible through a CDTA with a

physician medical director.

• Patient demand and retention rates prove adequate

patient acceptability to support this PrEP delivery

model.

• The One-Step PrEP® clinic proves to be financially

sustainable. Return on investment demonstrated at 9

months of clinic operation.

Thank You