Californians waiting to purchase HIV prevention medication through their pharmacies will have to wait a little longer. With the signing of California Senate Bill 159 (SB 159) into law earlier this month, Governor Gavin Newsom made the state the first in the nation to allow pharmacists to provide pre-exposure prophylaxis (PrEP) and post-exposure prophylaxis (PEP) under state protocol to be determined. Although the law will go into effect Jan. 1, customers won't be able to obtain the meds at pharmacies until lawmakers draft emergency regulations stipulating how the bill will be implemented. That should happen by July 2020.
What will happen Jan. 1 is the elimination of pre-authorization requirements for PrEP and PEP -- that's the other part of SB 159 that received less press coverage but is just as important. By requiring patients to obtain prior authorization before using their insurance benefits to obtain PrEP or PEP, insurance companies had been putting up an unnecessary barrier to critical HIV prevention treatment.
The efficacy of PrEP and PEP in dramatically reducing the transmission of HIV is well documented, and the authors of SB 159, State Senator Scott Wiener (D-San Francisco) and Assemblymember Todd Gloria (D-San Diego), have said the bill will increase access to these meds in order to dramatically lower the number of new HIV infections. Although PrEP has been available for seven years, and PEP even longer, the uptake of these medications has been less than overwhelming. As of 2016, there were an estimated 240,000 Californians with an indication for PrEP, but only 9,000 people were taking PrEP in the state, according to the California Department of Public Health, Office of AIDS. Recent reports on HIV transmission rates have shown a large disparity between black and Latino gay men and their white counterparts, and a corresponding disparity in access to PrEP and PEP. For PrEP, the new law allows pharmacists to provide a 60-day supply, after which the patient will need to see a physician to continue. But, of course, this will not begin until July.
The next nine months before PrEP and PEP go on sale at pharmacies without a prescription in California will not go to waste. While lawmakers are crafting regulations, stakeholders will have a chance to get buy-in from pharmacists -- the law doesn't mandate that they sell PrEP or PEP -- and train pharmacists in instructions for how to use PrEP.
"Pharmacists will be part of the solution to get us to zero HIV transmissions, plus access to care for those who need it," said Jon Roth, CEO of the California Pharmacists Association, a co-sponsor of the legislation. The San Francisco AIDS Foundation, APLA Health, the Los Angeles LGBT Center, Equality California, and the California Society of Health-Systems Pharmacists were the other co-sponsors.
Roth said an on-demand webinar with an e-learning module is in development and will be available to the association's 6,000-plus members by mid-November. Though it's too early to say what the training would look like, Roth said that two experts in PrEP and PEP -- Maria Lopez, Pharm.D., with Mission Wellness Pharmacy in San Francisco, and Robert Grant, M.D., M.P.H., with the University of California San Francisco School of Medicine -- were developing it. Through a collaborative practice agreement with the San Francisco Department of Public Health, Mission Wellness has already been selling PrEP without a prescription.
"We're also developing an awareness campaign, and we've already shared a news alert with members after the bill was signed, and put up a longer story since then," Roth said. "We will beat the drum over the next few months to build anticipation."
Local HIV/AIDS clinics and wellness organizations will also be spreading awareness and knowledge and may develop their own training modules for pharmacists. (The state doesn't register pharmacists to sell PrEP and PEP, but it will be auditing pharmacists who do sell it, to assess their knowledge.)
According to Courtney Mulhern-Pearson, M.P.H., senior director of policy and strategy at the San Francisco AIDS Foundation, another vehicle for awareness is the California Office of AIDS, which administers the state's AIDS Drug Assistance Program (ADAP). This office will also be crucial in getting pharmacist buy-in, because it already works with hundreds of pharmacies to deliver HIV meds.
"And [HIV/AIDS] organizations will be spreading the word about pharmacy access," Mulhern-Pearson said. "We need to raise awareness and uptake of PrEP and PEP across the state."
Mulhern-Pearson noted that parts of the state are PrEP and PEP deserts, partly because there are no LGBT centers -- a place where many access the medication -- although every part of the state is served by a pharmacy.
"Even in Los Angeles we observed, depending on the neighborhood, it can be hard to get to a clinic like ours," said Aaron Fox, director of government relations at the Los Angeles LGBT Center. "Accessing PrEP and PEP through pharmacies may be more convenient even for people who do have an LGBT center nearby. A patient might not want to go to a clinic that has a big rainbow on it, or a sign saying HIV or AIDS."
Fox added that pharmacists will be trained in a culturally appropriate way, and will -- unlike some doctors -- not slut-shame patients or tell them they don't really need the medication.
Fox and Mulhern-Pearson said that allowing pharmacies to sell PrEP will have another important benefit: a doorway to primary care. The law requires pharmacists to refer patients to a doctor if they want to be on PrEP longer than 60 days. "We've found that a lot of people may not have engaged with the health system but need PrEP or PEP," Fox said. "But once they get it, they're getting health care." Fox recalls one twentysomething patient at the LA LGBT Center who learned from the doctor that he had leukemia, just because he asked to get on PrEP. "He might not have learned that or gotten health care for it otherwise."