Getting Pharmacist-Prescribed PrEP Right to Promote Better Access

In 2019, the Department of Health and Human Services (HHS) released a plan to decrease new HIV infections by 90 percent by 2030. “Ending the HIV Epidemic in the U.S.” (EHE) recognizes that reaching this goal will require a multifaceted response and suggests many strategies to reduce new infections. Increasing pre-exposure prophylaxis (PrEP) access and use is a key component of the EHE strategy, and “[s]upporting state and local communities to expand innovative strategies to increase availability of PrEP” is a specific recommendation. Several policy mechanisms can help accomplish this, including authorizing pharmacists to prescribe PrEP to patients independently. There is growing interest in implementing such policies, with 14 states doing so between 2019 and 2023. While making PrEP prescriptions available in pharmacies has the potential to reach underserved communities, some implementation details will encourage optimal impact.  

A Package of PrEP Policies

Several policy mechanisms can enable pharmacists to prescribe PrEP directly to patients. Policies that authorize pharmacists to prescribe PrEP can be grouped into three categories: non-patient-specific collaborative practice agreements, statewide protocols or standing orders, and a framework of rules that govern the circumstances under which a pharmacist can prescribe medications. Each category has benefits and shortcomings; however, no matter which mechanism policymakers use, some associated policies can make PrEP prescribing more feasible for pharmacists to implement.

Offering PrEP prescribing requires pharmacists to commit time to evaluating if PrEP is clinically appropriate for a patient and counseling the patient on use and HIV prevention. If policies do not explicitly allow pharmacists to bill insurance for the time spent providing these services, there is little incentive for pharmacies to offer them. Policies that ensure pharmacists can seek reimbursement for PrEP-related services, preferably at the same rate as other health care providers, must accompany policies that authorize pharmacists to prescribe PrEP.

Before starting PrEP, patients must test negative for HIV and should be tested for other sexually transmitted infections. Authorizing pharmacists to order Clinical Laboratory Improvement Amendments (CLIA) waived tests is one way to facilitate this testing. CLIA-waived tests must be deemed by the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) as so simple to use and interpret that there is little risk of error. Some states may have existing policies that allow pharmacists to order CLIA-waived tests, but for those that do not, including this authorization along with PrEP-prescribing authority is important.  

Finally, policies that authorize pharmacist-prescribed PrEP should ensure that associated requirements, such as additional training and referrals for continuing care, are reasonable and feasible. Most states that have authorized pharmacist-prescribed PrEP included language that requires pharmacists to complete additional training before prescribing PrEP. The bills differ in how specifically they outline the type of training required. Although pharmacists and patients report that additional training prior to a pharmacist prescribing PrEP is desirable, it is important to ensure that the training is not so onerous that pharmacists are discouraged from completing it. Using COVID-19 vaccine administration as a comparison, HHS specified that pharmacists had to complete at least 20 hours of training before administering the vaccine. A similar training time commitment could be reasonable for prescribing PrEP.

Regarding referral requirements, California is a useful case study. The state’s original pharmacist-prescribed PrEP legislation allowed pharmacists to prescribe up to 60 days of PrEP once every two years and required them to share contact information for providers who could continue care. A survey of California pharmacists found that 42 percent thought the 60-day prescription did not allow enough time to ensure successful referral to continuing care. The state addressed this and other policies that could discourage pharmacists from offering PrEP-related services in 2024 with SB 339. This bill increased the initial amount of PrEP a pharmacist can prescribe to 90 days. A 90-day prescription seems like a middle-ground solution, since another study found that pharmacists preferred a shorter referral period over a longer one when asked to choose between 30 days or 180 days. California’s policy changes show how important it is to revisit policies if they are not producing the desired results or if stakeholders raise concerns.

Social and Individual Barriers Remain Relevant

Even a perfectly written and implemented pharmacist-prescribed PrEP policy may not increase PrEP uptake. Many factors influence a person’s decision to use PrEP, and ease of access is only one of them. Awareness and understanding of PrEP, HIV-related stigma, perception of HIV risk, distrust of the medical system, cost, and concerns about medication use have all been identified as barriers to PrEP uptake. Exploring the nuances of all of these barriers could fill a book, and no single policy solution will address many of these challenges.

Of these obstacles, cost is likely addressed most easily through policy. Associated with increased PrEP use, Medicaid expansion is one state-level policy that can decrease cost and increase access to care. Additionally, ensuring that not only PrEP medications, but also the associated care, is covered by insurance can address out-of-pocket costs. In fact, a recent study found a strong correlation between increased out-of-pocket costs and discontinuing PrEP use. There are programs that will cover medication costs for people without insurance; however, they do not cover associated care costs. Improving the availability of low-cost medical care could help address the cost of associated care for people without insurance.

Fully addressing the structural and individual barriers with a single policy solution is unlikely. However, focusing on health education and outreach efforts can help change perceptions of HIV risk, decrease stigma, and increase understanding of PrEP as a preventative care tool. Additionally, building awareness through public campaigns can help change individual perceptions about PrEP. This is also true for building awareness about pharmacist-prescribed PrEP. If people do not know that they can get PrEP from a pharmacist, then the policy change will have less impact.

PrEP has changed the HIV prevention landscape, and increasing its use is one way to reduce new HIV infections. Although policy barriers to pharmacist-prescribed PrEP can exist, comprehensive legislation can minimize them. Combining pharmacist-prescribed PrEP with policies that address the social and economic concerns of people who could benefit from PrEP can further expand access to the medication.

For further reading: Preventing HIV with Pharmacist-Prescribed PrEP