The Roundtable
Welcome to the Roundtable, a forum for incisive commentary and analysis
on cases and developments in law and the legal system.
on cases and developments in law and the legal system.
By Catherine Tang Catherine Tang is a freshman at the University of Pennsylvania majoring in Health and Societies with a concentration in Health Policy & Law. Despite its first human diagnosis in the 1930s, Human Immunodeficiency Virus (HIV) continues to remain a global health crisis nearly a century later. In the U.S. alone, there were 32,100 estimated new HIV infections in 2021 with an infection rate of 11.5 (per 100,000 people) [1]. Fortunately, due to modern scientific advances, it is possible to prevent infection. Treatments like pre-exposure prophylaxis (PrEP) can reduce the risk of contracting HIV by 99% [2]. However, PrEP is vastly underutilized in the U.S. and is used only by a small proportion of high-risk populations, including sexual minority men, trans women, cisgender women, people from rural areas, and sex workers [3]. As such, the individuals who would benefit the most from PrEP paradoxically lack access to it. For instance, PrEP is overwhelmingly recommended for Black and Latino communities, yet only 9% of eligible African Americans and 16% of eligible Latinos received a prescription for antiretroviral medication. Similarly, while young people aged 16 to 24 are one of the groups at the highest risk of HIV, only 16% of those for whom it is recommended had a prescription in 2020. Furthermore, out of the 90% of HIV-negative men who have sex with men who are aware of PrEP, only 42% used it in 2021. [4]
Therefore, pharmacies represent a critical medical care avenue, particularly for individuals facing limited access to transportation, high copay costs, and disparities in provider prescriptions. As such, it comes as little surprise that more than 85% of PrEP prescriptions are filled at commercial pharmacies[5]. Consequently, the CDC identified pharmacists as key professionals in achieving its goal of reducing new HIV infections in the U.S. by 90% by 2030 in its Ending the HIV Epidemic (EHE) Initiative [6]. This can be attributed to pharmacies’ more convenient location with 9 in 10 Americans living within 5 miles of a pharmacy. Furthermore, their weekend and evening hours are more flexible than those of traditional healthcare settings, especially given many pharmacies are transitioning to becoming 24-hour [7]. Pharmacies can also provide access to PrEP without the need for appointments. In other words, rather than having to schedule an appointment with a primary care provider, individuals can go to their local pharmacy and receive prompt treatment from someone they trust and to whom they regularly speak to about their health. Finally, pharmacists can help uninsured individuals circumvent the high cost of PrEP treatments by enrolling them in copay and manufacturer assistance programs [8]. Currently, seventeen states grant pharmacists varying degrees of direct prescribing authority [9], all of which have served as successful empirical examples. California was the first state in the country to pass such legislation in 2019 with SB 159, which permitted pharmacists to prescribe up to a 60-day supply of PrEP and required private insurance to cover the cost for patients with lower incomes [10]. Preliminary studies have shown that SB 159 increased the number of pharmacies that stock PrEP, and patients reported positive experiences with pharmacist-furnished PrEP [11]. Others quickly followed suit, with states like Oregon passing HB 2958 in 2021 that ensured pharmacists are reimbursed for PrEP services at the same rate as other health care providers, which expanded their reach and allowed them to preemptively offer HIV prevention treatment to those who may benefit the most from it [12]. Thus, looking into the future, a potential avenue for change is expanding the duration of pharmacists’ prescribing authority. While the CDC has a 90-day prescription recommendation, the majority of states, aside from Colorado, have much more stringent regulations that limit PrEP to 60 days and allow only one full course before requiring pharmacists to refer the patient to a primary care practitioner [13]. Given that community pharmacies are much more accessible for many populations than primary care, however, it may be beneficial to extend the deadline pharmacists are able to prescribe without needing a referral. A potential bill, SB 339, is already in committee in California, and if passed, will ensure pharmacists are reimbursed for their services and extend the 60-day supply to 90 days [14]. At the same time, however, it is important to consider the enduring barriers that pharmacists face. Despite the flurry of legislation, as of 2021, only 1 in 5 pharmacists have ever prescribed PrEP [15]. One reason behind this reluctance may be the need for additional training in PharmD programs. A study revealed that older pharmacists are more likely to be unfamiliar with PrEP, and the highest rates of pharmacists familiar with PrEP are concentrated in the Midwest, which has the lowest HIV prevalence [16]. Pharmacists have also reported low medication availability, difficulty with mail prescription refills, misinformation about costs, and privacy concerns as additional contributing factors [17]. Therefore, future legislation should focus on improving training programs. Curriculums should teach pharmacists how to navigate funding programs such as the Ryan White HIV/AIDS Program, how to evaluate PrEP-specific records and tests in patients’ electronic medical records, and reimburse them for their education and medical adherence efforts. Similarly, state law should provide resources for the monitoring and evaluation of expanded PrEP access to better understand which communities are or are not being reached by the expansion. Furthermore, there needs to be a mechanism or a social program in place to address the issue of out-of-pocket costs; increased access does little if the communities that need PrEP the most cannot afford it. Good empirical examples include the New York PrEP Assistance Program and the Philadelphia PrEP Navigator Program, which help patients develop an individualized PrEP plan, apply for medical benefits, and reduce the cost of services [18]. Ultimately, to successfully position pharmacists as key facilitators in the EHE Initiative, investment in both legislative advocacy and targeted clinical provider training is imperative. [1] “HIV & AIDS Trends and U.S. Statistics.” HIV.gov. https://www.hiv.gov/hiv-basics/overview/data-and-trends/statistics/ [2] “HIV Treatment as Prevention.” CDC. https://www.cdc.gov/hiv/risk/art/index.html [3] Zhao et al. “Pharmacy-Based Interventions to Increase Use of HIV Pre-exposure Prophylaxis in the United States: A Scoping Review.” AIDS Behavior. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8527816/ [4] Collins, Sonya. “Pharmacists expand access to PrEP in 17 states.” PharmacyToday. https://www.pharmacist.com/Publications/Pharmacy-Today/Article/pharmacists-expand-access-to-prep-in-17-states#:~:text=If%20not%20for%20pharmacists%20providing,break%20in%20hormonal%20contraception%20coverage. [5] Hilas, Olga. “Preexposure Prophylaxis for HIV Prevention.” U.S. Pharmacist. https://www.uspharmacist.com/article/preexposure-prophylaxis-for-hiv-prevention [6] “Ending the HIV Epidemic in the U.S. (EHE)”. CDC. https://www.cdc.gov/endhiv/index.html [7] Dong, Betty J. “Are Pharmacists Prepped for PrEP?” AIDS Education and Training Centers National Coordinating Resource Center. https://aidsetc.org/blog/are-pharmacists-prepped-prep [8] “Paying for PrEP.” CDC. https://www.cdc.gov/hiv/basics/prep/paying-for-prep/index.html [9] “Pharmacist Prescribing: HIV PrEP and PEP.” National Alliance of State Pharmacy Associations. https://naspa.us/blog/resource/pharmacist-prescribing-hiv-prep-and-pep/ [10] “SB-159.” California Legislative Information. https://leginfo.legislature.ca.gov/faces/billNavClient.xhtml?bill_id=201920200SB159 [11] Koester et al. “Attitudes about community pharmacy access to HIV prevention medications in California.” Journal of the American Pharmacists Association. https://escholarship.org/content/qt07c6r5p8/qt07c6r5p8_noSplash_a1c9edbfa895488a578e93779438700d.pdf [12] “HB2958 2021 Regular Session.” Oregon Legislative Information System. https://olis.oregonlegislature.gov/liz/2021r1/Measures/Overview/HB2958#:~:text=Requires%20health%20insurers%20to%20cover,of%20services%20provided%20by%20pharmacist. [13] Lathan, Nadia. “California pharmacists face barriers to offer HIV medications.” UC Berkely Public Health. https://publichealth.berkeley.edu/news-media/research-highlights/california-pharmacists-face-barriers-to-offer-hiv-medications/ [14] “SB-339.” California Legislative Information. https://leginfo.legislature.ca.gov/faces/billNavClient.xhtml?bill_id=202120220SB339 [15] Cooper et al. “Recommendations for Increasing Physician Provision of Pre-Exposure Prophylaxis: Implications for Medical Student Training.” Inquiry. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8142521/ [16] Broekhuis et al. “Midwest pharmacists’ familiarity, experience, and willingness to provide pre-exposure prophylaxis (PrEP) for HIV.” PLOS One. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6235377/ [17] “Pharmacist-initiated PrEP and PEP.” National Alliance of State & Territorial AIDS Directors. https://nastad.org/sites/default/files/2021-11/PDF-Pharmacist-Initiated-PrEP-PEP.pdf [18] “Where to get pre-exposure prophylaxis (PrEP) in Philadelphia.” Department of Public Health, City of Philadelphia. https://www.phila.gov/2022-10-17-where-to-get-pre-exposure-prophylaxis-prep-in-philadelphia/ The opinions and views expressed in this publication are the opinions of the designated authors and do not reflect the opinions or views of the Penn Undergraduate Law Journal, our staff, or our clients.
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