LAC 48:I.13611. HIV Pre-Exposure Prophylaxis (PrEP)

A. Under this protocol, pharmacists may assess for HIV status and high-risk behaviors in which pre-exposure prophylaxis against HIV would be warranted. B. The pharmacist may dispense and/or administer the patient a 30-day supply of any antiretroviral agent that is a currently FDA-approved or CDC-recommended medication or regimen for HIV pre-exposure prophylaxis, according to the following criteria. 1. The patient is 17 years of age or older, is (or is planning to become) sexually active or is at risk for sharing injection or drug preparation equipment, and has a desire to start a PrEP regimen. 2. Evidence of baseline negative HIV status is obtained, as documented by a pharmacist either: a. conducting a blood rapid test, which provides same-day results; b. drawing blood (serum) and sending the specimen to a laboratory for an antigen/antibody test, with results being received within seven days before initially dispensing and/or administering PrEP; or c. accepting patient’s outside documentation of a non-reactive blood rapid test or laboratory test with the patient’s name (matching their legal identification) dated within seven days before initially dispensing and/or administering PrEP. 3. Neither oral swab testing nor patient self-report of negative status are acceptable for evidence. C. Pharmacists must ask the following screening question. 1. Do you have existing kidney disease, or do you know if your kidney function is decreased for any reason? a. If the answer is yes, the pharmacist shall urgently order or refer the patient for a blood test to confirm creatinine clearance. The pharmacist may accept patient-provided creatinine clearance test results dated within 12 months from another lab or provider. i. If the patient’s creatinine values are acceptable for oral PrEP therapy, the pharmacist may proceed through the rest of the protocol. ii. If the patient’s creatinine values do not meet oral PrEP therapy minimums according to CDC Guidelines, and the pharmacist is able to administer injectable PrEP therapy, the pharmacist may proceed through the rest of the protocol for injectable PrEP therapy. iii. If the patient’s creatinine values do not meet oral PrEP therapy minimums according to CDC Guidelines and does not desire injectable PrEP or the pharmacist is unable to administer injectable PrEP, the pharmacist shall refer to an appropriate provider. 2. The following patients should NOT be provided PrEP under this protocol and should be referred to a primary care provider for further action: a. patients younger than 17 years of age; b. patients with reactive baseline HIV tests; c. patients with symptoms which could indicate acute HIV infection; or d. patients on medications contraindicated with PrEP therapy selected. 3. A pharmacist may administer injectable PrEP therapy, pursuant to R.S. 37:1164 and the LAC 46.LIII.521. 4. Other/Repeated Labs: Follow CDC Guidelines. a. The pharmacist is authorized to order recommended labs and perform necessary FDA-approved and CLIA-waived point-of-care tests for the patient OR to refer the patient to another provider to order lab work and accept results. b. At the patient’s request, PrEP refills will be authorized past the initial 30-day supply for oral or injectable therapy if recommended baseline and follow-up testing are done according to CDC Guidelines as ordered by one of the above mechanisms. 5. Counseling shall include (at minimum): a. instruction regarding proper medication use, adherence, schedule, and potential common and serious side effects (and how to mitigate them); i. For injectable PrEP therapies: the long drug "tail" of gradually declining drug levels when discontinuing injections and the risk of developing a drug-resistant strain of HIV during this time; b. description of signs/symptoms of acute HIV infection and recommended actions. c. education on PrEP/PEP; d. the necessity of follow up care with a primary care provider for usual care; and e. the importance and requirement of testing for HIV, renal function, lipid profile, Hepatitis B, and other sexually transmitted infections, per CDC Guidelines.