Sonya Collins
PrEP for HIV has made a significant impact in HIV prevention over the last decade. Since the combination of antiretrovirals tenofovir and emtricitabine (Truvada) earned FDA approval for the prevention of HIV in 2012, uptake among those for whom it is recommended has risen by an estimated 56% each year, according to data from Emory University’s Rollins School of Public Health. But major gaps remain between the number of people who could benefit from PrEP and the number who take it.
Just one in four of the people for whom PrEP is indicated take the prophylactic drugs. The gap between “could” and “does” is even wider in marginalized communities and among those hit hardest by the HIV epidemic.
To help close these gaps, the National HIV/AIDS Strategy for the United States (2022–2025) called for expansion of pharmacists’ prescribing authority and providing reimbursement to allow them to administer PrEP.
“Pharmacists can help address known barriers to HIV, particularly in PrEP underutilization,” said LCDR Neelam “Nelly” Gazarian, PharmD, AAHIVP, a senior policy analyst in the Office of Infectious Disease and HIV/AIDS Policy at HHS. “Pharmacies can be a nonstigmatizing venue. Pharmacists can also increase overall access to health care services, as 9 in 10 Americans live within 5 miles of a pharmacy and they may be open at different times than traditional health care settings.”
In 17 states, pharmacists have some degree of expanded authority to provide PrEP or PEP to their patients at community pharmacies or clinics and, in some cases, receive reimbursement for these services. These programs provide a model for what might be possible across the country if pharmacists in all settings had the necessary authority and were able to bill for the clinical care they provide.
“The goal is to end the HIV epidemic by 2030,” said Michael Murphy, PharmD, MBA, advisor for state government affairs at APhA. “Right now, we are not on track to meet that goal. Ensuring that there are more access points for patients to get into preventive medication is a way that we can help ensure we meet that goal.”
Significant gap in care
Individuals who take PrEP represent a small minority of those for whom it is indicated, and the disparities are starkest in the communities that may need the drug therapy the most. Most people for whom PrEP is recommended are Black or Latino, yet only 9% of eligible Blacks and 16% of eligible Latinos have been prescribed the antiretrovirals. Among whites for whom the drugs would be beneficial, 66% take them.
Young people ages 16 to 24 years are the least likely to take PrEP. Only 16% of those for whom it is recommended had a prescription in 2020. However, this percentage increases with age.
Zeroing in further, while nearly 90% of HIV-negative men who have sex with men were aware of PrEP, according to a 2021 CDC survey, only 42% used it.
Women are even less likely to use PrEP. Just one in ten cisgender women for whom it is recommended have been prescribed the pills. Among transgender women, 92% know about PrEP, while just over 30% of them take it.
Sexual minorities, such as gay, bisexual, and transgender people, are less likely to have access to health care than their heterosexual counterparts—especially Black, Latino, and younger members of these groups. Even those who do have a regular physician might not be offered PrEP. As of 2021, it was estimated that only one in five physicians had ever prescribed PrEP.
“Pharmacists can serve as another point of access to get patients into HIV preventive care,” Murphy said, “not necessarily to replace a specific health care professional, but to be another open door into longitudinal preventive care for patients.”
States that allow pharmacists to prescribe hormonal contraception illustrate how pharmacists increase access without necessarily supplanting other health professionals. According to a 2019 study by Anderson and colleagues in Obstetrics & Gynecology, in the first 2 years that Oregon pharmacists were authorized to prescribe oral and transdermal contraception, 10% of new prescriptions among Medicaid enrollees for these medications originated with pharmacists—the vast majority of which were community pharmacists.
Community pharmacies can increase access to PrEP not only by virtue of their ubiquitousness, but also in their ability to provide same-day PrEP, which may increase retention.
Ground zero for PrEP
Pharmacist-owner at Mission Wellness in San Francisco Maria Lopez, PharmD, prides herself on offering same-day PrEP to her patients. “We do the rapid HIV test so the patient can start that day because there’s some data to support same-day PrEP,” Lopez said.
California pharmacists were the first in the nation to be authorized to provide PrEP or PEP without a prescription. In 2019, SB 159 permitted pharmacists to prescribe up to a 60-day supply of PrEP in a 2-year period or a full 28-day regimen. Under this law, patients with lower incomes receive pharmacist-prescribed PrEP and PEP at little or no cost to them, and private insurance is required to cover up to a 60-day supply of this medication when initiated by a pharmacist.
SB 339, a so-called “fix-it” bill that has not yet become law, will authorize pharmacists to prescribe up to a 90-day supply of PrEP and require commercial health insurance to reimburse pharmacists for the patient care services provided in association with PrEP.
Under this law, Mission Wellness has served some of those in greatest need.
“I would say our patients have primarily been uninsured or patients who can’t get in to see a provider,” Lopez said. For example, they can help patients who could not get in to see a local physician when they lost their pills while visiting San Francisco or after just moving to town.
If not for pharmacists providing PrEP, Lopez said, “they definitely would’ve had a gap in their medication, their levels would go down, and then they would be at risk for HIV.”
The risks associated with a break in PrEP are analogous to those of a break in hormonal contraception coverage. A 2022 study in Obstetrics & Gynecology by Rodriguez and colleagues found that pharmacist prescription of hormonal contraception is associated with increased odds of 12-month continuation rates compared to physician prescriptions.
“It’s not the same thing as PrEP, but it showcases the impact that pharmacists can have in this area,” Murphy said.
PrEP patients at Mission Wellness are also predominantly Latino, which addresses a national and local need. “Overall, the number of Latinos in the city has gone down, but HIV rates among them have gone up,” Lopez said. In San Francisco County, Latinos accounted for 38% of new infections in the most recent data—up from 25% in 2012.
Expanding pharmacists’ reach
While California was the first state to pass laws allowing pharmacists to provide and be reimbursed for PrEP services, other states have since implemented laws that go further to expand pharmacists’ scope and reimbursement in this area.
Colorado law, according to pharmacy advocates, may be the most thorough in this respect. In Colorado, a statewide protocol allows pharmacists to provide PrEP to all eligible patients after the appropriate testing and requires that Medicaid and commercial health plans cover the service.
“The policy in Colorado addresses the two primary barriers to pharmacists being able to deliver HIV PrEP and PEP to their patients: scope of practice and reimbursement,” said Murphy.
“This sets up an efficient way for pharmacists to provide these services and increase access with minimal policy barriers and within a sustainable business model,” Murphy said.
In Oregon, pharmacists have been authorized since 2017 to prescribe PrEP and PEP after completing relevant continuing education. A more recent law, added to the books in 2021, ensures that pharmacists get reimbursed for PrEP and PEP services at the same rate as other health care providers.
The law expands pharmacists’ reach. That gives them the ability to offer PrEP preemptively to those who may benefit from it.
“If someone is picking up a prescription for another STI medication, we can talk about PrEP and see if they’d be interested,” said Jared Gallegos, PharmD, a clinical pharmacist at Central City Concern, a federally qualified health center in Portland. “If the patient wants to know why we’re asking, we just say ‘We think everyone’s sexual health is important, so we wanted to give you this option.’”
Adding the pharmacy as a point of access, he said, has helped reach patients who might not otherwise have started PrEP. “We’ve had patients who only got started on it because they saw the flyers here in the pharmacy,” Gallegos said.
“Any adult who wants to be on PrEP should be able to be on PrEP,” Gallegos said. “They don’t have to meet requirements about how much sex they are having or anything like that. If they request it, they should be able to be on it.”
Greater public health impact
Adding the pharmacy as an access point may also provide what many potential patients see as a less stigmatizing setting.
“Many of our patients haven’t wanted to see a primary care provider because there is some stigma in approaching a doctor about PrEP,” said Elizabeth Camper, PharmD, AAHIVP, pharmacy manager at AIDS Healthcare Foundation in Seattle. “Taking the stigma out of it is key. Hopefully pharmacists can do that and make it more accessible so they can approach us about these things.”
Camper and her colleague Jessi Truelove, PharmD, AAHIVP, a pharmacist on the strategic response team at AIDS Healthcare Foundation, run a pharmacist-operated PrEP clinic in a pharmacy in Seattle. The two also participated in the statewide demonstration project PIPAR (Pharmacy Integration Into PrEP and ART Provision and Retention).
While Washington is not among the 17 states where pharmacists have expanded scope of practice to provide PrEP, it is considered a pioneer in pharmacist-led PrEP services because of Seattle-based Kelley-Ross Pharmacy’s work in this area. Shortly after national guidelines for PrEP provision were made available in 2014, Kelley-Ross Pharmacy created its community pharmacist–managed HIV PrEP clinic. From March 2015 to February 2018, a total of 695 patients started PrEP at the clinic—most of them on the same day as their initial appointment. All patients who stayed in care throughout the pilot program, after a 25% dropout rate, remained HIV-negative until the end.
Through a collaborative drug therapy agreement, Camper and Truelove can prescribe same-day PrEP for HIV prevention. They also prescribe and administer routine vaccinations and treatment for STIs and order and monitor labs. Through a phlebotomy license, they perform venous blood draws through which they assess hepatitis B immunity, HIV status, syphilis exposure, and kidney function under serum creatinine levels.
If patients do not have a primary care provider and want one, pharmacists assist them in finding one. They also refer patients to other community resources such as charities providing clothing, food, and case management, if needed.
As the state of Washington recognizes pharmacists as health care providers, the law requires that they are reimbursed for the patient care services they provide, including PrEP therapy.
The program, Truelove said, has more far-reaching public health effects than on HIV prevention alone.
“During visits with patients, we’ve identified a lot of gaps in vaccines—[like with] TDAP, we’ve helped people hear about flu shots if they don’t have a primary care provider. We’ve gotten a lot of people their COVID boosters. I would say we are filling a vaccine need with our patients, and we are very proud of that,” she said.
Pharmacist-led PrEP programs underscore the impact pharmacists, when given the opportunity, can have on public health—an impact that was made clear during the COVID-19 pandemic. But advocates must get the message to policymakers that there is a role for pharmacists to play here.
“It comes down to policymaker education,” Murphy said. “Unfortunately, pharmacies are not the first place that people think of for getting PrEP and PEP prescriptions, but once that education happens—and a lot of it has come from seeing pharmacists provide increased access to COVID-19 testing, immunizations, and oral antivirals—more and more state and federal policymakers are understanding that this is where we should be looking.” ■