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Pre‐exposure Prophylaxis (PrEP) for HIV Prevention – Adult – Ambulatory [146]

Pre‐exposure Prophylaxis (PrEP) for HIV Prevention – Adult – Ambulatory [146] - Clinical Hub, UW Health Clinical Tool Search, UW Health Clinical Tool Search, Delegation/Practice Protocols, Ambulatory Delegation Protocols


Delegation Protocol Number: 146

Delegation Protocol Title:
Pre-exposure Prophylaxis (PrEP) for HIV Prevention – Adult – Ambulatory

Delegation Protocol Applies To:
UWHC Adult HIV Clinic

Target Patient Population:
Adult patients who are Human Immunodeficiency Virus (HIV)-negative and are at ongoing substantial
risk for acquiring HIV-1 infection and are being maintained on pre-exposure prophylaxis (PrEP) therapy

Delegation Protocol Champion:
James Sosman, MD – Department of Medicine, Division of Infections Disease, HIV Clinic Medical Director

Delegation Protocol Reviewers:
Jill Strayer, PharmD – Department of Pharmacy
Ashlin Samuel, PharmD – Department of Pharmacy
Luiza Kerstenetzky, PharmD – Department of Pharmacy
Joshua Vanderloo, PharmD – Department of Pharmacy

Responsible Department:
Drug Policy Program, Department of Pharmacy

Purpose Statement:
This protocol delegates authority from providers in the HIV Clinic to pharmacists to order emtricitabine-
tenofovir disoproxil fumarate (Truvada) for HIV pre-exposure prophylaxis (PrEP) and to place orders for
monitoring and HIV-1 screening throughout therapy. PrEP therapy will not be initiated based on this
protocol; this protocol delegates the maintenance of PrEP therapy to clinic-based pharmacists.

Who May Carry Out This Delegation Protocol:
Pharmacists who have been trained in the use of this delegation protocol.

Guidelines for Implementation:
1. This protocol is initiated when a provider signs an order for “Pharmacist to manage
emtricitabine/tenofovir (Truvada) PrEP Protocol”. Following the steps in this delegation protocol,
the pharmacist will place orders for emtricitabine-tenofovir disoproxil fumarate (Truvada) and
required laboratory tests.
2. Patients excluded from this protocol:
2.1. HIV-positive patients
2.2. Patient with CrCL < 60 mL/min estimated using the Cockroft-Gault or Salazar-Corcoran
equations
2.3. Pregnant patients
2.4. Hepatitis-B positive patients
2.5. Patients younger than 18 years of age
Copyright © 2017 University of Wisconsin Hospitals and Clinics Authority
Contact: Lee Vermeulen, CCKM@uwhealth.org Last Revised:
 
11/2017CCKM@uwhealth.org


3. Prior to initiating PrEP, the prescriber will complete the required REMS documentation for PrEP
therapy. This includes both the “Checklist for Prescribers: Initiation of TRUVADA for PrEP” and
“Agreement Form for Initiating TRUVADA for PrEP”. The completed forms will be uploaded to the
patient’s chart under the description “Medication Agreement” under the “Consent/Legal” tab for
reference
4. Prior to placing any orders, the pharmacist will verify that the patient meets criteria for PrEP therapy
as outlined in the US Public Health Service Preexposure Prophylaxis for the Prevention of HIV
Infection in the United States – 2014 Clinical Practice Guideline and Truvada Risk Evaluation and
Mitigation Strategy (REMS) materials. If the pharmacist determines the patient does not meet
criteria, PrEP prophylaxis will not be ordered and the pharmacist will consult with the provider.
5. Monitoring
5.1. The pharmacist will place orders for laboratory tests as outlined below. Prior to placing any
orders, the pharmacist will review the medical record to avoid any duplicate orders.
5.2. Pregnancy testing for women
5.2.1. Test to be ordered: Urine pregnancy (HCG), qualitative. In addition to ordering a
pregnancy test, the pharmacist will evaluate the patient’s pregnancy intent.
5.2.2. Frequency: Every 3 months
5.2.3. If pregnancy is detected or the patient expresses intent to become pregnant, delegation is
terminated. The pharmacist will notify the original authorizing provider who will resume
responsibility for the patient’s HIV-related care.
5.3. HIV testing (immediately prior to use, every 3 months)
5.3.1. Test to be ordered: HIV Ab/Ag Combo
5.3.2. If HIV-1 infection is detected, delegation is terminated. The pharmacist will notify the
original authorizing provider who will resume responsibility for the patient’s HIV-related
care.
5.4. Renal Function
5.4.1. Test to be ordered: Creatinine
5.4.2. Frequency: Prior to initiation, 3 months after, then every 6 months
5.4.3. If patient’s estimated CrCl is less than 60 mL/min, delegation is terminated. The
pharmacist will notify the original authorizing provider who will resume responsibility for
the patient’s HIV-related care.
5.5. Sexually transmitted infections (STI)
5.5.1. Tests to be ordered:
5.5.1.1. C. trachomatis and N. gonorrhoeae by TMA for urine
5.5.1.2. C. trachomatis by TMA, eye/throat/rectal only
5.5.1.3. RPR, Confirm if positive
5.5.2. Frequency: Prior to initiation, then every 6 months, even if asymptomatic
5.5.3. If patient has a positive STI test, the pharmacist will notify the original authorizing provider
for treatment. A positive STI does not result in termination of the delegation protocol.
5.6. Hepatitis C (yearly)
5.6.1. Test to be ordered: Hepatitis C Ab
5.6.2. If a patient has a positive hepatitis C test, the pharmacist will notify the original authorizing
provider for further action. A positive Hepatitis C Ab does not result in termination of the
delegation protocol.
6. The pharmacist will order the following regimen per this protocol if there are no abnormal tests or
lab findings:
6.1. Emtricitabine-tenofovir disoproxil fumarate (Truvada) 200-300 mg orally once daily.
Copyright © 2017 University of Wisconsin Hospitals and Clinics Authority
Contact: Lee Vermeulen, CCKM@uwhealth.org Last Revised:
 
11/2017CCKM@uwhealth.org


6.2. The pharmacist will order no more than a 90-day supply, renewable only after HIV testing
confirms that patient remains HIV-uninfected and labs are current.
6.3. Additionally, for women, the pharmacist will ensure that pregnancy test is negative and the
patient does not intend to become pregnant.
7. In addition to the above, the pharmacist will:
7.1. Provide the patient with risk-reduction and PrEP medication-adherence counseling and a copy
of the FDA-approved patient medication guide.
7.2. Document screening, education, and assessment in the medical record.
7.3. Assess patient for HIV-acquisition risk level, emtricitabine-tenofovir disoproxil fumarate
(Truvada) toxicity, and duration of therapy at every point of contact. If the pharmacist’s
assessment warrants termination of PrEP therapy, the original authorizing provider will be
notified.

Order Mode:
Laboratory: Cosign Required, Protocol/Policy
Medications: Protocol/Policy, Without Cosign

References:
1. US Department of Health and Human Services, Centers for Disease Control and Prevention.
Preexposure prophylaxis for the prevention of HIV infection in the United States—2014 clinical
practice guideline. http://www.cdc.gov/hiv/pdf/guidelines/PrEPguidelines2014.pdf. Published May
2014. Accessed November 2015.
2. Centers for Disease Control and Prevention (CDC),“Interim Guidance: Preexposure Prophylaxis for
the Prevention of HIV infection in Men Who Have Sex with Men”. MMWR Morb Mortal Wkly Rep,
2011, 60(3):65-8.[PubMed 21270743]
3. Centers for Disease Control and Prevention (CDC), “PrEP: A New Tool for HIV
Prevention.” http://www.cdc.gov/hiv/pdf/prevention_prep_factsheet.pdf. Published August 2012.
Accessed November 2015.
4. Truvada (emtricitabine/tenofovir) [prescribing information]. Foster City, CA: Gilead Sciences;
October 2013.
5. Truvada REMS Materials. Checklist for Prescribers: Initiation of Truvada for Pre-Exposure Prophylaxis
(PrEP). http://www.truvadapreprems.com/Content/pdf/Checklist_for_Prescribers.pdf. Published
2014. Accessed November 2015.
6. Truvada REMS Materials. Agreement Form for Initiating Truvada for Pre-Exposure Prophylaxis
(PrEP). http://www.truvadapreprems.com/Content/pdf/Agreement_Form.pdf. Published 2014.
Accessed November 2015.

Collateral Documents/Tools:
Checklist for Prescribers: Initiation of TRUVADA for PrEP
Agreement Form for Initiating TRUVADA for PrEP

Approved By:
UW Health Ambulatory Protocol Committee: May 2016
UW Health Laboratory Practices Committee: May 2016
UWHC Pharmacy and Therapeutics Committee: September 2016
UWHC Medical Board: November 2016
UW Health Chief Clinical Officer: November 2016

Copyright © 2017 University of Wisconsin Hospitals and Clinics Authority
Contact: Lee Vermeulen, CCKM@uwhealth.org Last Revised:
 
11/2017CCKM@uwhealth.org


Effective Date: November 2016

Scheduled for Review: November 2019
Copyright © 2017 University of Wisconsin Hospitals and Clinics Authority
Contact: Lee Vermeulen, CCKM@uwhealth.org Last Revised:
 
11/2017CCKM@uwhealth.org