State Laws May Determine Access to Pharmacy-based PrEP Clinics

Pharmacists are well-positioned in the community to help educate patients and prevent new HIV infections; new state laws allowing pharmacies to set up pre-exposure prophylaxis (PrEP) clinics will determine the size of their role. 

PrEP offers an effective means of protection for individuals testing negative for HIV; the FDA has approved the drug combination of 300 mg tenofovir and 200 mg emtricitabine sold under the name Truvada by Gilead Sciences. Emtricitabine 200 mg and tenofovir alafenamide 25 mg tablets are also under consideration by the FDA.

The list price of Truvada is $1,758 per month when taken daily; however, another alternative being proposed is the “2-1-1” approach. Instead of a daily pill taken indefinitely, an individual would take just 4 pills (2 pills within 2 to 24 hours before sex and 1 pill on day 2 and 1 pill on day 3). It is theorized that this type of PrEP regimen may be more convenient, cheaper, and elicit fewer side effects. So far, it reportedly has only been tested in men having sex with men and it has not been tested in women.

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PrEP plays an important role in addressing the HIV epidemic, says Lindsey Dawson, associate director of HIV Policy at the Kaiser Family Foundation, Washington, DC. When taken daily, it reduces the risk of HIV acquisition through sex by about 99%. Dawson says for this reason it is included in the federal government’s plan to “End the HIV Epidemic.” However, only an estimated 10% to 20% of individuals in the U.S. who have an indication for PrEP have received a prescription. “Disparities are significant, particularly among African Americans and Latinos, as well as among people living in the south. To the extent that PrEP provision in the pharmacy setting increases PrEP uptake and improves adherence, this could play a meaningful role in reducing new HIV infections,” says Dawson.

Paul Weidle, PharmD, MPH, a senior epidemiologist at the CDC’s Division of HIV/AIDS Prevention, Atlanta, GA, says the CDC is currently looking into ways pharmacists can support “Ending the HIV Epidemic”, including efforts to increase PrEP uptake. “There are very encouraging examples of where pharmacists have addressed challenges to be able to provide support for PrEP delivery, either directly as providers or under collaborative practice agreements. These challenges must be addressed more fully in order for pharmacists to develop and implement strategies that will improve PrEP uptake,” Weidle tells Drug Topics.

“It is hard to say how many pharmacists will begin prescribing PrEP, either by running specific PrEP clinics or offering PrEP in pharmacies with existing co-located clinical facilities,” Dawson says. “Offering PrEP in pharmacy settings could increase patients’ ability to access this highly effective preventive medication.” 

Addressing Barriers

Dawson says PrEP uptake is relatively low among certain groups, including gay and bisexual African American men; diversifying the locations and types of providers offering PrEP could be one way to address some of the existing barriers. “Pharmacists with the appropriate clinical facilities willing to offer PrEP are well-positioned providers, and the CDC guidelines offers clear direction on the clinical services and straightforward counseling that should be offered,” says Dawson.

“Physicians typically see their patients a few times per year; pharmacists see them monthly and often times several times per month. We are much more accessible, as patients only need to walk through the door and ask to speak to a pharmacist in most pharmacies,” Clint Hopkins, PharmD, owner of Pucci’s Pharmacy in Sacramento, CA, tells Drug Topics. He says this higher pharmacist-patient interaction frequency and easier access means more opportunity for pharmacists to discuss sexual health, risk factors, offer testing, and initiate PrEP. “Our greatest barrier is getting the patient’s insurance to pay for point-of-care testing. Many patients who are high-risk for HIV are also not financially situated to be able to pay for their own testing. Grant programs are one option that we are pursuing to get testing covered when patients are unable to pay.”

Glen Pietrandoni, senior director for patient care and advocacy for Walgreens pharmacies, says, as the most accessible healthcare providers in the nation, pharmacists can play a significant role in the care and prevention of HIV. “Walgreens has supported people living with HIV/AIDS since the beginning of the epidemic,” says Pietrandoni. “With more than 3,000 HIV-trained pharmacists in communities across the nation, we can uniquely support HIV prevention, education, and care.” 

According to Pietrandoni, Walgreens pharmacists support patients with medication counseling and information on effective HIV prevention methods including PrEP. He says the option for pharmacists to prescribe PrEP and conduct related tests is a very important issue in the war on HIV. “Walgreens supports lowering hurdles for patients to access effective prevention options and is in favor of expanding the scope of services pharmacists can provide. Preventing new infections and keeping HIV positive patients virally suppressed are both critical strategies to prevent the spread of the virus and ultimately help eradicate it entirely,” says Pietrandoni.

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Two current pharmacy-based PrEP clinics in the U.S. are Kelley-Ross Clinic in Seattle and Mission Wellness in San Francisco. Washington State has passed legislation that requires insurance providers to cover point-of-care testing provided by pharmacists; San Francisco is operating on a grant in cooperation with SF General Hospital. “There is no question that state laws can enhance access to PrEP in non-traditional settings or can create barriers,” says Dawson. 

She says a law that address insurance coverage of lab testing in pharmacies is one example of a policy that could remove an important barrier to PrEP. This would help address affordability and reimbursement of PrEP-related services. “Another example of policy that would have an impact on PrEP in the pharmacy setting is pharmacist scope of practice laws. These differ from state to state and could either limit or expand access depending on their content,” says Dawson.

Attempts to expand PrEP provision through pharmacies will need to consider several factors, such as pharmacist buy-in and education, reimbursement policies, and pharmacy infrastructure (i.e. access to lab testing), she says. The Kelley-Ross pharmacy in Seattle provides direct PrEP delivery and clinic operates under a collaborative drug therapy agreement that allows pharmacists to initiate and manage tenofovir disoproxil fumarate/emtricitabine under the supervision of a physician medical director. 

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This pharmacist-managed PrEP clinic has been found to be a successful alternative model of PrEP care-a study conducted by pharmacists at the clinic found that its model provided high initiation rates and good compliance. The pharmacists evaluated 714 patients, 695 (97.3%) of whom initiated PrEP and 513 patients (74%) patients who began medication the same day as their initial appointment. The mean age at initiation of treatment was 34.7 years. The researchers found that among those patients who filled their prescription, 90% had a mean proportion of days covered (PDC) greater than 80%. There were no HIV seroconversions, but there were 207 diagnoses of sexually transmissible infections (mainly chlamydia and gonorrhea cases). 

Hopkins says a PrEP clinic can be a source of revenue, but how well enlisted pharmacists are in combating the HIV epidemic will be determined by state laws and reimbursement policies. “New HIV infections are still occurring in an era where we have a prevention method that the general population either isn’t educated about or do not have adequate access to obtain. We want to reduce the number of new HIV infections to zero by getting everyone who is at risk tested and those interested and eligible on prevention medication.”