California Expands Access to HIV Prevention Drugs

California Senate Bill 159, signed by Governor Gavin Newsom earlier this week, allows pharmacies to offer pre-exposure prophylaxis (PrEP) and post-exposure prophylaxis (PEP) HIV prevention medications without a prescription in a similar manner to birth control and emergency contraceptives provided certain, specific requirements are fulfilled.

California pharmacists, after completing a mandatory training program approved by the California State Board of Pharmacy, could provide PrEP or PEP medications in specified amounts if the pharmacist determines the patient meets the clinical criteria for PrEP or PEP consistent with federal guidelines. The Bill also prohibits insurance companies from requiring patients to obtain prior authorization before using their benefits to obtain the medications.

Senate Bill 159 defines ‘pre-exposure prophylaxis’ as a ‘fixed-dose combination of tenofovir disoproxil fumarate (TDF) (300mg) with emtricitabine (FTC) (200mg) or another drug or drug combination determined by the board to meet the same clinical eligibility recommendations provided in CDC guidelines.’

The Bill states a pharmacist shall furnish at least a 30-day supply, and up to a 60-day supply of PrEP if all of the following conditions are met:

  1. The patient is HIV negative, as documented by a negative HIV test results obtained within the previous seven days from an HIV antigen/antibody 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 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.
  4. The pharmacist provides counseling to the patient on the ongoing use of pre-exposure 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 provided to receive subsequent prescriptions for pre-exposure prophylaxis and that a pharmacist may not furnish a 60-day supply of pre-exposure prophylaxis to a single patient more than once every two years.
  5. The pharmacist documents, the the extent possible, the services provided by the pharmacist in the patient’s record in the system maintained by the pharmacy. The pharmacist shall maintain records of pre-exposure prophylaxis furnished to each patient.
  6. The pharmacist does not furnish more than a 60-day supply of pre-exposure prophylaxis to a single patient more than once every two years, unless directed otherwise by a prescriber.
  7. The pharmacist notifies the patient’s primary care provider that the pharmacist completed the requirements. If the patient does not have a primary care provider or refuses to 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 pre-exposure prophylaxis.

A pharmacist may furnish a complete course of HIV PEP if all the following conditions are met:

  1. The pharmacist screens the patient and determines the exposure occurred within the previous 72 hours and the patient otherwise meets the clinical criteria for postexposure prophylaxis consistent with the CDC guidelines.
  2. The pharmacist provides HIV testing that is classified as waived under the federal Clinical Laboratory Improvement Amendments of 1988 (42 USC Sec 263a) or determines there patient is willing to undergo HIV testing consistent with CDC guidelines. If the patient refuses to undergo HIV testing but is otherwise eligible for post exposure prophylaxis under this section, the pharmacist may furnish post exposure prophylaxis.
  3. The pharmacist provides counseling to the patient on the use of postexposure prophylaxis consistent with CDC guidelines, which may include education about side effects, safety during pregnancy and breast feeding, adherence to recommended dosing, and the importance of timely testing and treatment, as applicable for HIV and sexually transmitted diseases. The pharmacist shall also inform the patient of the availability of pre-exposure prophylaxis for persons who are at substantial risk of acquiring HIV.
  4. The pharmacists 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.