C.M.R. 02, 392, ch. 43, app 392-43-2 - Prescribing, Dispensing, and Administering HIV Prevention Drugs For Preventive Care

HIV Post-Exposure Prophylaxis (PEP) Statewide Protocol

Preventive Care HIV Post-Exposure Prophylaxis (PEP) Statewide Protocol

Consistent with the manufacturer's instructions for use approved by the US Food and Drug Administration (FDA), a pharmacist may independently prescribe, dispense and administer HIV prevention drugs.

STANDARDIZED PATIENT ASSESSMENT PROCESS ELEMENTS:

Utilize the standardized PEP Patient Intake Form Utilize the standardized PEP Assessment and Treatment Care Pathway Form Utilize the standardized PEP Patient Informational Handout Form Utilize the standardized PEP Provider Notification Form

PHARMACIST EDUCATION AND TRAINING

Prior to a pharmacist independently prescribing, dispensing, and administering HIV prevention drugs, the pharmacist shall be knowledgeable of the manufacturer's instructions for use and shall have completed a comprehensive training program related to the prescribing, dispensing, and administering of HIV prevention drugs.

* Note: A pharmacy may create and use an electronic format for the PEP Patient Intake Form, PEP Assessment and Treatment Care Pathway, PEP Patient Informational Handout, and PEP Provider Notification if the information is identical to the forms included in this protocol.

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Regimen Selection (check one):

[] Option 1 (preferred):

Emtricitabine 200mg /tenofovir disoproxil fumarate 300mg (Truvada® or generic) once daily for 28 days

PLUS

Raltegravir 400mg twice daily for 28 days

[] Option 2:

Emtricitabine 200mg /tenofovir disoproxil fumarate 300mg (Truvada® or generic) once daily for 28 days

PLUS

Dolutegravir 50mg once daily for 28 days

Selection Notes:

Dosing adjustments with renal dysfunction if CrCl <50 mL/min If contraindications to raltegravir or dolutegravir exist, or for other reasons the preferred regimen cannot be given, then the "alternate regimens" per CDC guidelines should be referenced and used Other FDA-approved regimens can be used if they become available. Formulation cautions and dose adjustments for antiretroviral medications shall minimally follow the CDC guidelines and package insert information for all regimens Although labeling is for a 28-day supply, 30 days is recommended for prescribing due to the products being available only in 30-day packaging and high cost of the medications which could provide a barrier to availability and care. If able, 28-day regimens are appropriate if the pharmacist/pharmacy is willing to dispense as such Pregnancy is not a contraindication to receive PEP treatment as Truvada® and Isentress® are preferred medications during pregnancy. If the patient is pregnant, please report their demographics to the Antiretroviral Pregnancy Registry:http://www.apregistry.com If the patient is breastfeeding, the benefit of prescribing PEP outweigh the risk of the infant acquiring HIV. Package inserts recommend breastfeeding. "Pumping and dumping" may be considered. Consider consulting with an infectious disease provider, obstetrician, or pediatrician for further guidance If using dolutegravir, monitor for drug-drug interactions and limit the dose of metformin to a maximum of 1,000mg per day

COUNSELING POINTS (at minimum):

Proper use of medication, dosage, schedule, and potential common and serious side effects (and how to mitigate) The importance of medication adherence with relation to efficacy of PEP Signs/symptoms of acute HIV infection and recommended actions The patient should be instructed on correct and consistent use of HIV exposure precautions including condoms and not sharing injection equipment For women of reproductive potential with genital exposure to semen, emergency contraception should be discussed The necessity of follow up care with a primary care provider for usual care The importance and requirement of follow up testing for HIV, renal function, hepatic function, hepatitis B and C, and sexually transmitted infections Inform the patient of the availability of pre-exposure prophylaxis Drug Interactions (such as polyvalent cations with raltegravir/dolutegravir)

PHARMACIST MANDATORY FOLLOW-UP:

The pharmacist will notify the patient's primary care provider of the dispensing of the post-exposure prophylaxis drugs. If the patient does not have a primary care provider, or refuses consent to notify their primary care provider, the pharmacist shall provide the patient a list of physicians, clinics, or other health care providers regarding follow-up care.

Pharmacist Signature_____________ Date___ /____ /____

Patient Information Post-Exposure Prophylaxis (PEP) for Human Immunodeficiency Virus (HIV)

Pharmacy Name:________________________

Pharmacy Address:________________________

Pharmacy Phone Number:________________________

This page contains important information for you; please read it carefully.

You have been prescribed Post-Exposure Prophylaxis (PEP) to help prevent Human Immunodeficiency Virus (HIV). Listed below are some key points to remember about these medications, and a list of next steps that will need to be done in order to confirm the PEP worked for you.

Key Points

You must start the medications within 72 hours of your exposure Take every dose. If you miss a dose, take it as soon as you remember If it is close to the time of your next dose, just take that dose. Do not double up on doses to make up for the missed dose Do not stop taking the medication without first asking your doctor or pharmacist The most common side effect is stomach upset. Taking the medication with food can help with stomach upset. Over-the-counter nausea and diarrhea medications are okay to use with PEP if needed Avoid over-the-counter pain medications like ibuprofen or naproxen while taking PEP

Follow-up and Next Steps

1. Contact your primary care provider to let them know you have been prescribed PEP because they will need to order lab tests and see you. The pharmacy cannot do these lab tests.

2. The tests we will be recommending to check at 6 weeks and at 3 months are listed below. The listed labs will involve a blood draw. Your provider may choose to do more tests as needed.

HIV test

Hepatitis B surface antigen and surface antibody

Hepatitis C antibody

Treponema pallidum antibody

Comprehensive metabolic panel

3. If you think that you might still be at risk of HIV infection after you finish the 28-day PEP treatment, talk to your doctor about starting Pre-Exposure Prophylaxis (PrEP) after finishing PEP

Provider Notification Post-Exposure Prophylaxis (PEP) for Human Immunodeficiency Virus (HIV)

Pharmacy Name:_____________

Pharmacy Address:_____________

Pharmacy Phone: Pharmacy Fax:_____________

Dear Provider_____________ (name), (______) ______ - ______ (FAX)

Your patient____________ (name___ /____ /____DOB) has been initiated treatment for HIV Post-Exposure Prophylaxis (PEP) at__________________Pharmacy.

This regimen consists of:

_______________________________________________________

_______________________________________________________

This regimen was initiated on__________ (Date).

We recommend an in-clinic office visit with you or another provider on your team within 1-2 weeks of starting HIV PEP. Listed below are some key points to know about PEP and which labs are recommended to monitor.

Provider pearls for HIV PEP:

Emtricitabine/tenofovir disoproxil fumarate needs renal dose adjustments for CrCl less than 50 mL/min. Please contact the pharmacy if this applies to your patient Emtricitabine/tenofovir disoproxil fumarate and raltegravir are both safe in pregnancy. If your patient is pregnant or becomes pregnant, they may continue PEP for the full 28 days NSAIDs should be avoided while patients are taking HIV PEP to avoid drug-drug interactions with emtricitabine/tenofovir disoproxil fumarate Emtricitabine/tenofovir disoproxil fumarate is a first-line option for Hepatitis B treatment. This is not a contraindication to PEP use, but we recommend you refer Hepatitis B positive patients to an infectious disease or gastroenterology specialist If your patient continues to have risk factors for HIV exposure, consider starting Pre-Exposure Prophylaxis (PrEP) after the completion of the 28-day PEP treatment course

We recommend ordering the following labs at 6 weeks after the initiation date for HIV PEP:

HIV test

Hepatitis B surface antigen and surface antibody

Hepatitis C antibody

Comprehensive metabolic panel

Treponema pallidum antibody as appropriate

Pregnancy test as appropriate

STI screening as appropriate (chlamydia, gonorrhea at affected sites)

We recommend ordering the following labs at 12 weeks after the initiation date for HIV PEP:

HIV test

We recommend ordering the following labs at 6 months after the initiation date for HIV PEP:

HIV test

Hepatitis C antibody

If you have further questions, please contact the pharmacy or call the HIV Warmline. The HIV Warmline offers consultations for providers from HIV specialists and is available every day at: (888) 448-4911. For more information about PEP, please visit the CDC website at cdc.gov/hiv/basics/pep.html

Notes

C.M.R. 02, 392, ch. 43, app 392-43-2