By Jackie Miller
Special acknowledgement to Maria Lopez for her contributions to this article.
Joe Smith, a gay man previously living in Boston, moved to San Francisco two months ago and was in danger of running out of his PrEP medication to remain HIV negative. Having been on PrEP for over three years, he was about to run out after exhausting nearly all efforts to find a provider in San Francisco, until he found Mission Wellness Pharmacy. Mission Wellness provided him a same-day appointment where, in under an hour, the pharmacist had conducted a PrEP visit; Joe left the visit with PrEP in hand. New legislation in California will make it easier for people to obtain PrEP in this way by broadly enabling pharmacists to dispense a limited supply of this medication without a prescription from a medical provider.
Explaining PrEP and PEP
Pre-exposure prophylaxis (PrEP) is a medication used to prevent HIV before potential exposure. Currently, Truvada is the only CDC recommended therapy for PrEP that is FDA-approved for all populations. Recently, the FDA approved the prodrug formulation of Truvada, called Descovy, for PrEP, but the approval was limited to certain populations. In addition to PrEP, post-exposure prophylaxis (PEP) can also prevent HIV infection. PEP is initiated after someone has been potentially exposed to HIV and involves taking three drugs, commonly including Truvada.
Barriers to Accessing PrEP and PEP
Despite PrEP’s proven effectiveness, it is highly underutilized. It is estimated that only about 10% of the total 1.2 million people who could benefit from PrEP are potentially receiving the medication. Unfortunately, Truvada's high price tag continues to be a barrier to receiving PrEP/PEP, and other bureaucratic challenges, such as difficulty in obtaining insurance company approval, have also hindered many from accessing the medication. Additionally, because the CDC guidelines recommend testing and follow up for someone on PrEP, it must be accessed via a visit to a primary or specialty care provider. Unfortunately, not all primary care providers provide PrEP, and it can be difficult to obtain even when they do, limiting the ability of persons who need PrEP to access this important HIV prevention tool. However, pharmacists are well poised to alleviate some of the barriers associated with seeing a medical provider.
Difficulties in Accessing Primary Care and Obtaining Physician Visits
Quick access to PrEP, and particularly PEP, is necessary to provide the best chance for HIV prevention. However, Marilyn Stebbins, PharmD, a professor of clinical pharmacy at UCSF, points out that “in order to see a physician, you need to make and wait for your appointment – it’s not done ‘on-demand.’” Long wait times before receiving a PrEP prescription leaves patients vulnerable for longer, and PEP must be started within 72 hours of HIV exposure to be effective; thus, a lag in obtaining an appointment can be detrimental to patient health. The already long wait times observed in accessing physicians through primary care are further exacerbated by primary care physician shortages in California and throughout the U.S. With only two regions of California meeting federal guidelines for primary care physician-to-patient ratios and a current shortfall of 8,400 physicians (and growing) nationally, lack of physician presence will inevitably drive appointment wait-times up. Stebbins commented that seeing a pharmacist could mitigate this challenge associated with obtaining PrEP and PEP: “We know that you can walk into a pharmacy and get service. There are 24-hour pharmacies that could be providing PrEP or PEP…pharmacies are where people live, work, and shop – they’re access points that should make access more consumer friendly and patient friendly.”
Stigma as a Barrier to PrEP/PEP Access
Unfortunately, face-to-face time with a primary care provider does not ensure that PrEP/PEP will be discussed. Maria Lopez, PharmD, an HIV pharmacist and founder of Mission Wellness Pharmacy (MWP), spoke about the role that stigma can play in PrEP/PEP initiation or lack thereof, stating that both the patient and provider may contribute to lack of discussion; physicians may be reluctant to ask patients about their sexual history and habits, and patients may be unwilling to share this information for fear of being stigmatized or labeled. Patients may be more likely to share details about their sexual history if prompted, but studies show that physicians are often unwilling or do not talk about sexual behavior. A 2006 Atlanta-area study found that, among surveyed primary care physicians, 58% asked about sexual activity at a routine visit and only 12-34% asked about the components of a sexual history. Another study that sampled HIV-positive men and women in California found that overall, only two-thirds of patients reported a physician discussing safer sex. Among physicians who do talk to their patients about sexual health, some physicians may still stigmatize the prescription of PrEP/PEP. Oliver Bacon, MD, a clinical professor of medicine at UCSF, said that potential discomfort with a patient’s sexuality and/or sexual behavior can serve as a barrier to physician prescription of PrEP/PEP. Myers et al. expressed that a stigma-free environment for patients can be created in pharmacies because pharmacists are not usually associated with particular health conditions. Lopez believes that more trained providers offering PrEP in additional, accessible settings, “such as community pharmacies, can decrease barriers and increase access [to PrEP]. We need to put more providers out there to provide PrEP.”
Pharmacists’ Demonstrated Ability in Providing Similar Services
Pharmacist initiation of PrEP/PEP can allay challenges with accessing primary/specialty care and procuring PrEP/PEP prescriptions from medical providers. Evidence demonstrating that HIV-trained pharmacists can positively influence treatment outcomes among HIV-positive individuals provides reason to believe that they could also successfully provide HIV prevention services. Furthermore, pharmacists have already demonstrated their ability to provide other prevention services, such as managing cardiovascular risk factors (e.g., blood pressure, total and LDL cholesterol). Additionally, the California HIV/AIDS Policy Research Center found that pharmacists view prescribing authorities for PrEP/PEP similar to that of naloxone, oral contraceptives, and vaccines, all of which they can already administer or initiate.
Innovative Models for Providing PrEP and PEP
Lopez, a graduate of the UCSF School of Pharmacy, founded MWP in San Francisco’s Mission District as the first one-stop PrEP program in California, a stand-alone model pharmacy that allows pharmacists to initiate and furnish PrEP directly to consumers. Although great work is happening at MWP, this model of providing PrEP from a community pharmacy is the exception rather than the norm. As a demonstration project with the San Francisco Department of Public Health, MWP receives grant funding and operates under a collaborative practice agreement (CPA) to allow pharmacists to initiate PrEP. Elsewhere, most patients must see a medical provider in a clinic in order to receive PrEP. Mission Wellness was inspired by the Kelley-Ross Pharmacy, located in Seattle, Washington. Initiated in 2015 as the first ever direct-to-consumer PrEP clinic, KRP also operates under a CPA to provide HIV prevention services. Their model demonstrated success in preventing HIV and was financially sustainable; its financial sustainability is possible because of landmark legislation passed in Washington that allows pharmacists to bill for patient care services. Ideally, other community pharmacies would allow pharmacists to bill for their services, but this is dependent on state-specific rules and regulations.
Recent Legislation in California
Healthforce researchers recently contributed to the analysis of SB 159, the California Senate bill that aims to improve access to PrEP/PEP, largely by establishing community pharmacies as new, additional access points for PrEP. The analysis of SB 159 was conducted under the California Health Benefits Review Program (CHBRP), which performs independent analyses of state legislative bills related to health insurance benefit mandates or benefit mandate repeals. CHBRP conducts several analyses on varying bill topics each year, and legislators use CHBRP’s analyses to inform their voting decisions. In describing the bill’s effect, Senator Scott Weiner, the author of SB 159, said, “Far too many people who need PrEP lack access to it, and allowing pharmacists to provide PrEP will reduce barriers and help us end new HIV infections. Community and retail pharmacies are deeply rooted in neighborhoods and are easy for people to access. It makes a lot of sense to include these key healthcare resources in our fight to end the HIV epidemic.” Robert Grant, MD, a professor of medicine at UCSF, also described why PrEP is important and how SB 159 will increase access: “PrEP is highly safe and effective and is a cornerstone in our aspiration to end HIV transmission and disease, along with testing and treatment. PrEP is widely used in some communities, where HIV rates are plummeting, while PrEP is not yet available in other communities…This new law in California will make PrEP available in pharmacies that are already nestled in communities, earning trust every day through service and convenience. Putting PrEP in pharmacies is the next huge leap toward ending the HIV transmission.” Governor Newsom signed SB 159 into law on October 7, 2019. However, the signed bill contains amendments, including new language that will only allow pharmacists to dispense up to a 60-day supply of PrEP. Limiting the length of time for which pharmacists can furnish PrEP dampens the effect of the bill by requiring patients to seek long-term prescription at a medical clinic. Amendments aside, the passage of SB 159 represents a shift in attitude toward increasing PrEP/PEP access through expansion to community pharmacies.
Getting to Zero
Pharmacists have already been striving for the ability to provide additional services. Last year, CHBRP analyzed two other bills, SB 1285 and SB 1322, that would have also expanded scope of practice. Although neither of these bills passed, their introduction to the legislature demonstrated continued efforts among pharmacists to expand the services they can provide and to be paid for those services. By expanding pharmacists’ scope of practice, the passage of SB 159 represents a positive step toward achieving the goals of the Getting to Zero SF consortium, which is aligned with UNAIDS vision of “Getting to Zero” (i.e., zero new HIV infections, zero HIV deaths, and zero HIV stigma by 2020). Including pharmacists in the fight against HIV makes the goal of “getting to zero” more achievable by breaking down barriers to obtaining PrEP/PEP for HIV prevention and reducing stigma associated with these treatments, which empowers patients with the knowledge and medications that they need to take charge of their sexual health.
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Jackie Miller is a research analyst with the Institute for Health Policy Studies and Healthforce Center. Her projects focus on a range of research including community health workers, workforce policies and workforce supply and demand.