4052.02.
(a) Notwithstanding any other law, a pharmacist may initiate and furnish HIV preexposure prophylaxis and postexposure prophylaxis in accordance with this section.(b) For purposes of this section, the following definitions apply:
(1) “Preexposure prophylaxis” means a fixed-dose combination of tenofovir disoproxil fumarate (TDF) (300 mg) with emtricitabine (FTC) (200 mg), or another drug or drug combination that meets the same clinical eligibility recommendations provided in CDC guidelines.
(2) “Postexposure prophylaxis” means either of the following:
(A) Tenofovir disoproxil fumarate (TDF) (300 mg) with
emtricitabine (FTC) (200 mg), taken once daily, in combination with either raltegravir (400 mg), taken twice daily, or dolutegravir (50 mg), taken once daily.
(B) Tenofovir disoproxil fumarate (TDF) (300 mg) and emtricitabine (FTC) (200 mg), taken once daily, in combination with darunavir (800 mg) and ritonavir (100 mg), taken once daily.
(3) “CDC guidelines” means either of the following publications by the federal Centers for Disease Control and Prevention:
(A) “2017 Preexposure Prophylaxis for the Prevention of HIV Infection in the United States – 2017 Update: A Clinical Practice Guideline.”
(B) “Updated Guidelines for Antiretroviral Postexposure Prophylaxis After Sexual, Injection Drug Use, or Other Nonoccupational Exposure to HIV – United States, 2016.”
(b)
(c) Before furnishing preexposure prophylaxis or postexposure prophylaxis to a patient, a pharmacist shall complete a training program approved by the board on the use of preexposure prophylaxis and postexposure prophylaxis. The board shall consult with the California Pharmacists Association and the Office of AIDS, within the State Department of Public Health, on training programs that are appropriate to meet the requirements of this subdivision.
(c)
(d) A pharmacist may furnish an initial course
a 30-day supply of preexposure prophylaxis as determined by the federal Centers for Disease Control and Prevention guidelines if the
pharmacist completes all of the following: if all of the following conditions are met:
(1)Provides HIV testing and confirms a negative test result or determines the patient has recently received a negative HIV test result consistent with the most recent guidelines from the federal Centers for
Disease Control and Prevention. If
(1) The patient is HIV negative, as documented by a negative HIV test result obtained within the previous seven days from an HIV antigen/antibody test or antibody-only test, or from a rapid, point-of-care fingerstick blood test approved by the federal Food and Drug Administration. If the patient does not provide evidence of a negative HIV test in accordance with this paragraph, the pharmacist shall order an HIV test. If the test results are not transmitted directly to the pharmacist, the pharmacist shall verify the test results to the pharmacist’s satisfaction. If the patient tests positive for HIV infection, the pharmacist or person administering the test shall inform the patient that there are numerous treatment options available and identify followup testing and care that may be recommended, including contact information for medical and psychological services.
direct the patient to a primary care provider and provide a list of providers and clinics in the region.
(2) The patient does not report any signs or symptoms of acute HIV infection on a self-reported checklist of acute HIV infection signs and symptoms.
(3) The patient does not report taking any contraindicated medications.
(2)Provides
(4) The pharmacist provides
counseling to the patient on the ongoing use of preexposure prophylaxis consistent with the most recent guidelines from the federal Centers for Disease Control and Prevention, prophylaxis, which may include education about side effects, safety during pregnancy and breastfeeding, adherence to recommended dosing, and the importance of timely testing and treatment, as applicable, for HIV, renal function, hepatitis B, hepatitis C, sexually transmitted diseases, and pregnancy for individuals of child-bearing capacity.
The pharmacist shall notify the patient that the patient must be seen by a primary care provider to receive subsequent prescriptions for preexposure prophylaxis and that a pharmacist may not furnish a 30-day supply of preexposure prophylaxis to a single patient more than once every two years.
(5) The patient reports having normal kidney function, and the pharmacist orders a test to measure kidney function. The patient shall provide contact information for the patient and sign an agreement to stop taking preexposure prophylaxis if laboratory results indicate that the patient should not take preexposure prophylaxis. The pharmacist shall contact the patient if laboratory results indicate that the patient should not take preexposure prophylaxis.
(3)Documents
(6) The pharmacist documents, to the extent possible, the services provided by the pharmacist in the patient’s health record. The pharmacist shall maintain records of preexposure prophylaxis furnished to each patient.
(7) The pharmacist does not furnish a 30-day supply of preexposure prophylaxis to a single patient more than once every two years, unless directed otherwise by a prescriber.
(4)Notifies
(8) The pharmacist notifies the patient’s primary care provider that the pharmacist completed the requirements specified in this subdivision. If the patient does not have a primary care provider, or refuses consent to notify the patient’s primary care provider, the pharmacist shall provide the patient a list of physicians and surgeons, clinics, or other health care service providers to contact regarding ongoing care for preexposure prophylaxis.
(d)A pharmacist may refill a prescription pursuant to this section if, prior to refilling the prescription, the pharmacist completes all of the following:
(1)Ensures the patient is clinically eligible for use of preexposure prophylaxis consistent with the most recent guidelines from the federal Centers for Disease Control and Prevention, which may include providing or determining the patient has received timely testing and treatment, as applicable, for HIV, renal function, hepatitis B, hepatitis C, sexually transmitted diseases, and pregnancy for individuals of child-bearing capacity.
(2)Documents the services provided by the pharmacist in the patient’s health record.
(3)Notifies the patient’s primary care provider that the pharmacist completed the requirements specified in this subdivision. If the patient does not have a primary care provider, or refuses consent
to notify the patient’s primary care provider, the pharmacist shall provide the patient a list of physicians and surgeons, clinics, or other health care service providers to contact regarding ongoing care for preexposure prophylaxis.
(e) A pharmacist may furnish a complete course or 30-day supply of postexposure prophylaxis if the pharmacist completes all of the following: following conditions are met:
(1) Screens The
pharmacist screens the patient and determines the exposure occurred within the previous 72 hours and otherwise meets the clinical criteria for consideration of postexposure prophylaxis consistent with the most recent guidelines from the federal Centers for Disease Control and Prevention. CDC guidelines.
(2) Provides The pharmacist
provides HIV testing or determines the patient is willing to undergo HIV testing consistent with the most recent guidelines from the federal Centers for Disease Control and Prevention. CDC guidelines. If the patient refuses to undergo HIV testing but is otherwise eligible for postexposure prophylaxis under this section, the pharmacist may furnish postexposure prophylaxis.
(3) Provides The pharmacist provides counseling to the patient on the use of postexposure prophylaxis consistent with the most recent guidelines from the federal Centers for Disease Control and Prevention,
CDC guidelines, which may include education about side effects, safety during pregnancy and breastfeeding, adherence to recommended dosing, and the importance of timely testing and treatment, as applicable, for HIV and sexually transmitted diseases.
(4) Notifies The pharmacist notifies the patient’s primary care provider of the postexposure prophylaxis treatment. If the patient does not have a primary care provider, or refuses consent to notify the patient’s primary care provider, the pharmacist shall provide the patient a list of physicians and surgeons, clinics, or other health care service providers to contact regarding
followup care for postexposure prophylaxis.
(5) The pharmacist does not furnish postexposure prophylaxis to a single individual more than two times in a calendar year.
(f) A pharmacist initiating or furnishing preexposure prophylaxis or postexposure prophylaxis shall not permit the person to whom the drug is furnished to waive the consultation required by the board and the Medical Board of California. board.
(g)Notwithstanding any other law, a pharmacist is not required to provide the counseling, assessments, or tests specified in subdivision (c), (d), or (e) if the pharmacist cannot conduct the counseling, assessments, or tests at a location that is sufficiently private to permit the pharmacist to comply with the federal Health Insurance Portability and Accountability Act and applicable state law governing the privacy of medical information, meets the sanitation standards under applicable law governing pharmacy practice, and allows the pharmacist to provide the services without being interrupted by others or called away
to perform other duties.
(h)The board and the Medical Board of California are each authorized to ensure compliance with this section. Each board is specifically charged with enforcing this section with respect to its respective licensees.
(i)
(g) The board may board, by July 1, 2020, shall
adopt emergency regulations
to implement this section
in accordance with the most current guidelines from the federal Centers for Disease Control and Prevention. CDC guidelines. The adoption of regulations pursuant to this subdivision shall be deemed to be an emergency and necessary for the immediate preservation of the public peace, health, safety, or general welfare. The emergency regulations authorized by this subdivision are exempt from review by the Office of Administrative Law. The emergency regulations authorized by this subdivision shall be submitted to the Office of Administrative Law for filing with the Secretary of State and shall remain in effect until the earlier of 180 days following their effective date or the effective date of regulations adopted pursuant to Section 4005.
(j)This section does not limit a pharmacist’s scope of practice described in Section 4052.2.