Pharmacies Grapple With Red Tape as States Try to Allow Pharmacists to Prescribe PrEP

Studies have shown that PrEP, which now can be prescribed with a newer drug, Descovy (emtricitabine/tenofovir alafenamide), can reduce the risk of contracting HIV by up to 99%. It is also a key part of the federal government’s plan to end new HIV infections by 2030. But purchases of PrEP have been sluggish—partly, prevention advocates say, due to obstacles to obtaining the medication. Because of systemic racism and lack of access to health care systems, PrEP uptake is particularly low among young, gay and bisexual African-American men, and advocates say diversifying the locations and types of providers offering PrEP could address some existing barriers. Many of the people most at risk for contracting HIV are also more likely to find roadblocks to accessing health care or experience stigma at the doctor’s office. 

 

This year, state lawmakers across the country have introduced legislation to increase access to PrEP, and several bills, including ones introduced in New York, New Jersey, and Utah, would expand the scope of practice for pharmacists, allowing them to prescribe and dispense PrEP.

Bills in New Hampshire (HB 1404) and Washington state (SB 5562 and HB 1551) would allow minors to access PrEP without parental consent.

The impetus for the New York bill was California’s passage of SB 159, according to state Assembly sponsor Didi Barrett. “We think this will help people who don’t have a doctor or don’t feel comfortable talking with their doctor about sex or sexual health,” Barrett said.

These bills are in various stages in the legislative process. The New York bill is currently stalled due to concerns from the American Medical Association, according to Barrett, but she said she was confident their issues could be worked out.

Devil in the Details

But there are details, and devils within, that determine how well the bills might work if passed and signed into law. Are pharmacists well trained to prescribe medications? Will pharmacists be reimbursed for their consulting time? Though California’s law was ballyhooed as the first in the nation, it was Oregon that passed a similar law, first. But Jonathan Frochtzwajg, public policy and grants manager of the Cascade AIDS Project, told TheBody that although Oregon pharmacists can prescribe PrEP, they aren’t doing so.

“The vast majority of pharmacists lack the training to assess patients, and billing systems aren’t configured to allow pharmacists to get reimbursed for their services in the same way as other health care providers,” he said. “Our full-time PrEP navigator has never heard of it happening.” Frochtzwajg added that Cascade AIDS Project is developing a bill that would address the barriers to pharmacists prescribing PrEP.

Those two details were addressed in the Colorado bill, HB 20-1061, which was signed into law in July by Gov. Jared Polis. The bill allowing pharmacists to prescribe PrEP was pushed by statewide LGBTQ advocacy organization One Colorado and the Colorado Pharmacists Society to reduce some of the barriers to accessing PrEP, especially in rural parts of the state, according to One Colorado’s policy director Michael Crews.

“We often see that fear of discrimination from primary care providers can prevent [people] from asking for PrEP,” he said. “There’s not a lot of visibility of PrEP and PEP in rural Colorado, and there’s a lack of communication and knowledge on the part of many health care providers. We hope that one quick interaction with the pharmacist will allow easier access to this lifesaving medication.” According to the Colorado Department of Health, there were about 455 people newly diagnosed with HIV there in 2019, up from 409 in 2018.

Colorado lawmakers and policy advocates used the California bill as a template, including the elimination of prior authorization for the meds. But they also tweaked a few items, Crews says, including the addition of a consulting fee for pharmacists—paid for by insurance companies—and a provision that allows pharmacists to keep providing PrEP (California pharmacists can provide a 60-day supply before sending customers to a doctor). As in California, Colorado pharmacists will be required to take a training course on PrEP before they can prescribe. Protocol spelling out the details of how the law will be implemented is in development, and the law will take effect Jan. 1.

As Californians are learning, just passing a law won’t immediately mean that people can walk into any pharmacy and walk out with PrEP on day one. First, policymakers say it’s not yet clear how many pharmacists will offer this service, especially in rural, more conservative parts of the state—areas where advocates see a very low PrEP uptake.

As for big pharmacy chains, it’s not clear when or whether they will opt in, said Gina Moore, Pharm.D., M.B.A., assistant dean for clinical and professional affairs at the University of Colorado Anschutz Medical Campus. Moore, who served as president of the Colorado Pharmacists Society as the bill was being crafted, said that state laws allowing pharmacists to prescribe contraception and smoking cessation meds could provide some clues. “[For smoking cessation and contraception], we’ve seen three big chains that have opted in: King Soopers/Kroger, Albertsons/Safeway, and Costco, plus independent pharmacies,” she said. “As for Walgreens and CVS pharmacies offering PrEP, we aren’t sure what they will do yet, but if they opt in, very likely they will come up with their own training. HMOs will do their own thing.”

The current executive director of the Colorado Pharmacists Society, Emily Zadvorny, Pharm.D., BCPS, affirmed that there was no carrot or stick to encourage pharmacist buy-in. “Our board will promote the availability of protocols, and, fortunately we have seen a lot of interest from independent pharmacies, especially in central Denver.” Moore and Zadvorny said that getting pharmacist input early in the bill-crafting process was helpful in raising awareness.

Still, there may be some hurdles to accessing PrEP and PEP even if pharmacists opt in throughout the state. For one, pharmacists must require a recent, negative HIV test result before prescribing. But there aren’t many pharmacies with rapid testing on-site, and free testing labs aren’t widespread in the state. And PrEP, at least for long-term use, requires testing for kidney function every three months. The Colorado law authorizes pharmacists to order the tests, but there’s nothing in the law that makes the tests free. As in California and other states, PrEP users may have to pay out of pocket for lab tests, depending on their insurance or lack of insurance.

Many Ways to Increase Access

Despite the caveats, efforts to expand the scope of pharmacists to prescribe PrEP in California, Colorado, and other states are all good, according to Mitchell Warren, executive director of AVAC.

“We should be in effect de-medicalizing prevention to a certain extent, just like cholesterol screening, so that people don’t have to go through the gauntlet of doctor’s appointments and insurance calls. It’s hard to go into a pharmacy and not hear about flu shots. Awareness of PrEP should be just as widespread. People need to know that, first, PrEP exists, and second, all the places they can access it.”

Warren said that he doesn’t want to risk safety or cut out the health care establishment. “But we do want to empower people and take some of the burden off doctors.” And he understands that conversations about sexual health are more complicated and nuanced than flu shots. But he said that public health campaigns, which are still too few and far between, are necessary to get the conversation started.

“There is no right way or wrong way to boost access [to PrEP]. Certain states are trying certain methods. Allowing pharmacists to be leaders in health care delivery is an important step.” He said other strategies, such as allowing pharmacists to form collaborative practice agreements with doctors, and eliminating parental consent for minors in accessing PrEP, as New Hampshire and Washington state lawmakers are attempting, can also work.

Efforts to teach doctors to have conversations about PrEP and sexual health are another way to expand access to prevention services. One benefit of the legislative process for crafting the Colorado bill, said One Colorado’s Crews, is education and awareness. “We engaged with the state medical society to convince them of the need to train up and better understand the needs of the LGBTQ population.”

[This story was originally published by The Body.]