3 Colo. Code Regs. § 719-1-C
Pre-Exposure and Post-Exposure Prophylaxis of HIV
This collaborative pharmacy practice statewide protocol authorizes qualified Colorado-licensed pharmacists ("Pharmacists") to provide pertinent assessment of risk of HIV acquisition and prescribe pre-exposure and post-exposure prophylaxis medications for the prevention of HIV infection according to and in compliance with all applicable state and federal laws and rules.
Pharmacists may prescribe and dispense FDA approved medication(s) to eligible patients according to indications and contraindications recommended in current guidelines from the U.S. Centers for Disease Control and Prevention (CDC)1,3 and the United States Preventive Services Task Force (USPSTF)2.
Prior to prescribing and dispensing HIV prevention medication per this protocol, the pharmacist must:
1. Hold a current license to practice in Colorado
2. Be engaged in the practice of pharmacy
3. Have earned a Doctor of Pharmacy degree or completed at least 5 years of experience as a licensed pharmacist
4. Carry adequate professional liability insurance as determined by the Board
5. Complete a training program accredited by the Accreditation Council for Pharmacy Education, or its successor entity, pursuant to the protocol (in compliance with Board Rule 17.00.50 b.2.)
6. Pharmacists must also follow all board rules for statewide protocols in section 17.00.00.
The pharmacy shall ensure that appropriate space is available to provide counseling and ensure confidentiality. Records:
A. Pursuant to Pharmacy Board Rule 17.00.50, a process shall be in place for the pharmacist to communicate with the patient's primary care provider and document changes to the patient's medical record. If the patient does not have a primary care provider, or is unable to provide contact information for his or her primary care provider, the pharmacist shall provide the patient with a written record of the drugs or devices furnished, and lab test(s) ordered, and any test results.
B. Pharmacists shall comply with all aspects of Pharmacy Board Rules 17.01.00 and 17.02.00 with respect to the maintenance of proper records.
Pre-Exposure Prophylaxis (PrEP) Protocol
Under this protocol, Pharmacists may assess for HIV status and high-risk behaviors in which pre-exposure prophylaxis against HIV would be warranted.
The pharmacist may consider and offer the patient an oral antiretroviral agent listed in Table Ia, or other
FDA approved/CDC recommended medications or regimens can be used if they become available, according to the following criteria:
1. Evidence of HIV negative status as documented by an FDA- approved test, or rapid CLIA-waived point of care antigen/antibody fingerstick blood test, or by drawing blood (serum) and sending the specimen to a laboratory for an antigen/antibody test with results being received within 7 days prior to the initiation of PrEP. Neither oral swab testing nor patient report of negative status are acceptable for evidence.
2. Persons who meet eligibility requirements for PrEP per CDC guidelines in the following categories:
a. Sexually-Active Adults
* Without acute or established HIV infection
* Anal or vaginal sex in the past 6 months
AND at least one of the following:
* HIV-positive sexual partner (especially if partner has an unknown or detectable viral load)
* Has tested positive for bacterial STI in the past 6 months
* Gonorrhea, Chlamydia, and Syphilis for men who have sex with men (MSM) and transgender women (TGW) who have sex with men, including those who inject drugs
* Gonorrhea and Syphilis for heterosexual women and men including persons who inject drugs b. Persons Who Inject Drugs (PWID)
* Adult person
* Without acute or established HIV infection
* Any injection of drugs not prescribed by a clinician in past 6 months
AND any of the following:
* Any sharing of injection or drug preparation equipment in past 6 months
* Risk` of sexual acquisition (see above)
c. Any patient who requests PrEP, even if no specific risk behaviors are elicited
Patients who should NOT be prescribed PrEP under this protocol and should be referred to primary care provider for further action:
* Patients with baseline HIV tests indicating existing HIV infection
* Recent flu-like symptoms in the past month as this may suggest acute HIV infection not yet detectable (fever, fatigue, myalgia, skin rash, headache, pharyngitis, cervical adenopathy, arthralgia, night sweats, diarrhea)
* Patients on medications contraindicated with PrEP therapy selected
* Patients with history of hypersensitivity reaction to PrEP therapy selected
TABLE 1a - MEDICATION OPTIONS
Other FDA approved / CDC recommended medications or regimens can be used if they become available.
Formulations, cautions and dose adjustments for antiretroviral medications shall minimally follow the CDC guidelines and package insert information for all regimens.
Medication | Age/Weight | Frequency | Duration of Therapy | Notes |
FTC/TDF (F/TAF) emtricitabine 200 mg/tenofovir disoproxil fumarate 300mg (Truvada® or generic) | [GREATER THAN EQUAL TO]35 kg | Once daily | Prescription issued for 30 days with no refills if baseline labs not completed; or up to 90 days if baseline labs completed. Refill quantity only until next scheduled lab follow up. | May take with or without food. Not recommended for CRCL <60 ml/min. |
FTC/TAF (F/TAF) emtricitabine 200mg/tenofovir alafenamide 25mg (Descovy®) | [GREATER THAN EQUAL TO]35 kg | Once daily | Prescription issued for 30 days with no refills if baseline labs not completed; or up to 90 days if baseline labs completed. Refill quantity only until next scheduled lab follow up. | May take with or without food. Not recommended for CRCL <30 ml/min. Should only be used for at-risk cis-gender men and transgender women. Pharmacist must review drug/drug interaction considerations as per package insert. |
CAB Cabotegravir 600mg/3mL (Apretude®) extended-release injectable suspension for intramuscular (IM) use | >35kg | Month 1: 4-week optional oral lead in of daily cabotegravir 30mg (Vocabria®) tablet Month 2: 600mg (3mL) IM gluteal injection administered by healthcare professional on last day of oral therapy or within 3 days of last oral dose Month 3 (and every 2 months thereafter): 600mg (3ml) IM gluteal Injection administered by healthcare professional | Prescription issued for 1 injection at a time following the dosing and lab schedule | See package insert for instructions regarding planned or unplanned missed injections Drug resistant HIV-1 variants have been identified with use of Apretude® (Black Box Warning) |
Labs:
* PrEP cannot be started without a negative HIV Ag/Ab test at baseline.
* Pharmacist is authorized to order the following labs for the patient OR can refer to another provider for ordering and accept lab results.
* PrEP refills will not be authorized past the initial 30 day supply for oral therapy if recommended baseline testing is not done by one of the above mechanisms.
* PrEP refills will not be authorized in absence of scheduled follow up for injectable therapy
TABLE 2a - ROUTINE REQUIRED MONITORING OF INJECTABLE TREATMENT
Test | Frequency | CDC recommendations | Notes |
HIV (Ag/Ab & HIV 1 RNA assay | Baseline + Prior to each injection + when stopping CAB | Required | If positive, refer |
Three site STI screening (syphilis, gonorrhea, chlamydia) | Baseline + Every 4 months (starting with 3rd injection) for MSM & TGW Every 6 months (starting with 5th injection) for heterosexual ly-active persons When stopping CAB (only for MSM, TGW) | Recommended | If positive - refer for care |
Need to continue PrEP | Annually | Recommended if at continued risk | Discuss with patient |
TABLE 2b-ROUTINE REQUIRED MONITORING OF ORAL TREATMENT
Test | Frequency | CDC Recommendations | Notes |
HIV Ag/Ab | Baseline + Every 3 months | Required | If positive, refer |
HIV-1 RNA assay and assess for signs/symptoms of acute HIV infection | Every 3 months + when stopping PrEP | Required | If positive, refer |
Three site STI screening (syphilis, gonorrhea, chlamydia) | Baseline + Every 3 months + when stopping PrEP for MSM & TGW Every 6 months for heterosexually-active persons | Recommended | If positive, refer for care |
Serum creatinine | Baseline + Every 6 mo. If age [GREATER THAN EQUAL TO]50 or eCrCL <90 mL/min at PrEP initiation Every 12 mo. If continuing PrEP + When stopping PrEP | Recommended | If CrCL <60 mL/min, cannot use F/TDF If CrCL <30 mL/min, cannot use F/TAF If rapid decline in kidney function, consult nephrology |
Weight, Lipid panel (if taking F/TAF) | Baseline, + Every 12 months | Recommended | |
Hepatitis B screening | Baseline | Recommended | If positive - refer for care |
Need to continue PrEP | Annually | Recommended if at continued risk | Discuss with patient |
Counseling (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 PrEP/nPEP
* Signs/symptoms of acute HIV infection and recommended actions
* Consistent and correct use of condoms and prevention of STIs
* The necessity of follow up care with a primary care provider for usual care
* The importance and requirement of testing for HIV, renal function, hepatitis B, and sexually transmitted infections.
* For injectable cabotegavir: the long drug "tail" of gradually declining drug levels when discontinuing CAB injections and the risk of developing a drug resistant strain of HIV during this time. To help patients safely discontinue CAB PrEP injections pharmacists should:
* Re-educate patients about the tail and the risks during declining CAB levels
* Asses ongoing risk/indications
* If PrEP is indicated prescribe oral F/TDF or F/TAF beginning with 8 weeks after last injection
* Educate about nPEP
* Conduct HIV-1 RNA tests at each quarterly follow up visit after discontinuation ofCAB injections and discuss the importance of keeping these follow up appointments
Documentation:
* The pharmacist will notify the patient's primary care provider of a record of all medications prescribed. If a patient does not have a primary care provider, the pharmacist will provide the patient with a list of providers and clinics for which they may seek ongoing care.
* The pharmacist will also follow all documentation rules in Pharmacy Board Rule 17.
Referrals to primary care provider:
* If a patient tests positive for HIV infection, the pharmacist will refer/direct the patient to a primary care provider and provide a list of providers and clinics in that region for confirmatory testing and follow up care. A list of providers may be found at: https://cdphe.colorado.gov/living-with-hiv
* If a patient tests positive for an STI, the pharmacist will refer/direct the patient to a primary care provider and provide a list of providers and clinics in that region for confirmatory testing and follow up care. A list of providers may be found at: https://cdphe.colorado.gov/living-with-hiv
* If a patient tests positive for Hepatitis B, the pharmacist will refer/direct the patient to a primary care provider and provide a list of providers and clinics in that region for confirmatory testing and follow up care.
* Urgent evaluation referral for symptoms or signs of acute renal injury or acute HIV infection.
* If a female patient becomes pregnant while on PrEP
* Usual care for any other issues, stress importance of routine primary care and health maintenance.
Non-Occupational Post-Exposure Prophylaxis (nPEP) Protocol
Non-Occupational Post-Exposure Prophylaxis (nPEP) is the use of antiretroviral drugs after a single high-risk event to decrease the risk of HIV seroconversion. nPEP must be started as soon as possible to be effective, and always within 72 hours of the possible exposure. This particular protocol addresses non occupational post-exposure prophylaxis (nPEP) only, those with occupational exposures are not eligible and should be referred for care.
Under this protocol, pharmacists may assess patients 13 and older for high-risk exposure to HIV and prescribe antiretroviral drugs if appropriate. Patients under 18 years of age require parental consent to access this Protocol. nPEP should only be provided for infrequent exposures.
If the pharmacy is not able to provide care to the patient, or if the patient does not qualify for care at the pharmacy, the patient should be referred to another provider. PEP providers in Colorado include the STD Clinic at Denver Public Health (303.602.3540) and local emergency departments (CDPHE to comment).
If the following criteria are met, antiretroviral agents in Table 3a are recommended:
* The exposure must have occurred within 72 hours
* A rapid antibody CLIA waived point of care test yields a negative result for HIV. However, if a rapid test is not available, and nPEP is otherwise indicated, therapy should still be initiated.
* Exposure to a source individual known to be HIV-positive. Exposure of:
o Vagina
o Rectum
o Eye
o Mouth
o Other mucous membranes
o Nonintact skin
o Percutaneous contact (e.g., injecting drugs with a contaminated needle or needle stick injury)
WITH
o Blood
o Semen
o Vaginal secretions
o Rectal secretions
o Breast milk
o Any body fluid visibly contaminated with blood
* Exposure types with the highest risk of transmission of HIV are:
o Needle sharing during injection drug use
o Percutaneous needle stick
o Receptive anal intercourse
* If exposure with a source in which the HIV status is not known, nPEP may be considered and antiretroviral agents in Table 3a may be prescribed. NPEP should strongly be considered after exposure in an individual who also meets the criteria for PrEP therapy (see Colorado Statewide Protocol for Pre-Exposure Prophylaxis of HIV).
Patients who should NOT be prescribed nPEP under this protocol and should be referred to primary care provider for further action:
* Patients younger than 13 years of age.
* Patients taking any contraindicated medications per guidelines and package insert information
* Patients with baseline rapid HIV tests indicating existing HIV infection should be referred to a primary care provider.
* Patients who have a potential exposure but have been consistently adherent to PrEP
* If a child presents to the pharmacy with a request for NPEP and is potentially a victim of child abuse, child protective services MUST be contacted.
Other Considerations:
* If the case involves a sexually assaulted person, patients should also be examined and co-managed by professionals specifically trained in assessing and counseling patients and families during these circumstances (e.g., Sexual Assault Nurse Examiner [SANE] program staff). Resources may be found at https://www.ccasa.org/gethelp/health-related-organizations/
* If a child presents to the pharmacy with a request for nPEP and is potentially a victim of child abuse, child protective services MUST be contacted 1-844-CO-4-KIDS.
TABLE 3a - MEDICATION OPTIONS
Other FDA approved / CDC recommended medications or regimens can be used if they become available. Formulations cautions and dose adjustments for antiretroviral medications shall minimally follow the CDC guidelines and package insert information for all regimens.
Medication | Age/Weight | Dose | Duration of Therapy | Notes |
PREFERRED REGIMEN | ||||
emtricitabine 200 mg/tenofovir disoproxil fumarate 300mg (Truvada® or generic) PLUS raltegravir 400mg OR Dolutegravir 50mg | [GREATER THAN EQUAL TO] 13 years | Once daily #28 no refills Twice daily #56 no refills Once daily #28 no refills | 28 days | Dosing adjustments with renal dysfunction if CrCL <60 ml/min. Dolutegravir should not be used in pregnant women If contraindications to raltegravir or dolutegravir exist, or for other reasons the preferred regimen cannot be given, then "alternative regimens" per CDC guidelines should be referenced and used. |
TABLE 4a - ROUTINE REQUIRED MONITORING OF TREATMENT
Labs:
* All efforts should be made to obtain a negative HIV test at baseline. However, the sooner PEP is initiated, the more effective it is. If the patience refuses to undergo HIV testing but is otherwise eligible for postexposure prophylaxis under this section, the pharmacist may furnish postexposure prophylaxis.
* Ask the following screening question:
* Do you have existing kidney disease, or do you know if your kidney function is decreased for any reason?
In this event, pharmacist should make arrangements to refer patient for a Scr blood test urgently as nephrotoxicity can occur with acute/chronic kidney disease (CrCL <60 ml/min).
* Pharmacist is authorized to order the following labs for the patient OR can refer to another provider for ordering and accept lab work results.
* Pharmacist must make every reasonable effort to follow up with patient post-treatment regimen at 4-6 weeks and test for confirmation of HIV status and make known to patient that repeat HIV testing is recommended at 3 and 6 months as well.
Test | Frequency | CDC recommendations | Notes |
HIV | Baseline + Post-exposure at week 4-6, and months 3 and 6 | Required | If positive, refer. |
STI screenings (syphilis, gonorrhea, chlamydia) | Baseline | Recommended | If positive - refer for care |
Serum creatinine | Baseline + @4-6 weeks. | Recommended | |
ALT/AST | Baseline + @4-6 weeks. | Recommended | |
Hepatitis B screening | Baseline + 6 mo | Recommended | If positive - refer. If negative and clinically appropriate, vaccinate |
Hepatitis C screening | Baseline + 6 mo | Recommended | If positive - refer |
Pregnancy | Baseline + @4-6 weeks. | Recommended | Pregnancy is not a contraindication to NPEP |
Counseling (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 nPEP
* 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 diseases
* If appropriate, general discussion of pre-exposure prophylaxis at future time.
Documentation:
* The pharmacist will notify the patient's primary care provider of a record of all medications prescribed. If a patient does not have a primary care provider, the pharmacist will provide the patient with a list of providers and clinics for which they may seek ongoing care.
* The pharmacist will also follow all documentation rules in Rule 17.
Referrals:
* If a patient tests positive for HIV infection, the pharmacist will refer/direct the patient to a primary care provider and provide a list of providers and clinics in that region for confirmatory testing and follow up care. A list of providers may be found at: https://cdphe.colorado.gov/living-with-hiv
* The patient should be referred immediately for guideline based follow-up HIV testing and care, and follow-up testing for STIs, Hepatitis C, and Hepatitis B.
* If a patient tests positive for an STI, the pharmacist will refer/direct the patient to a primary care provider and provide a list of providers and clinics in that region for confirmatory testing and follow up care. A list of providers may be found at: https://cdphe.colorado.gov/living-with-hiv
* If a patient tests positive for Hepatitis B or C, the pharmacist will refer/direct the patient to a primary care provider and provide a list of providers and clinics in that region for confirmatory testing and follow up care. A list of providers may be found at: https://cdphe.colorado.gov/living-with-hiv
* Signs of symptoms of acute drug toxicities or serious side effects
* Urgent evaluation referral for symptoms or signs of acute renal injury or acute HIV infection.
* Usual care for any other issues, stress importance of routine primary care and health maintenance.
1CDC. Preexposure prophylaxis for the prevention of HIV infection in the United States, 2021 update Clinical Practice Guideline. Available at: https://stacks.cdc.gov/view/cdc/112360
2USPTF. Preexposure Prophylaxis for the Prevention of HIV Infection US Preventive Services Task Force Recommendation Statement. JAMA. 2019;321(22):2203-2213. doi:10.1001/jama.2019.6390
3CDC. Updated Guidelines for Antiretroviral Postexposure Prophylaxis After Sexual, Injection Drug Use or Other Nonoccupational Exposure to HIV - United States, 2016. Available at: https://stacks.cdc.gov/view/cdc/38856
3 CCR 719-1-C