HIV Prevalence and PrEP Uptake
The introduction of pre-exposure prophylaxis (PrEP) for HIV has permanently changed the course of HIV prevention. PrEP is estimated to prevent over 90% of infections in men who have sex with men and 70% of infections in people who inject drugs. PrEP uptake(defined as the ratio of individuals who receive a prescription for PrEP to the estimated number of individuals with indications for initiating PrEP) has increased across the country since the first FDA-approved drug became available in 2012 — contributing to a reduction of 12% in overall estimated HIV infections from 2017 to 2021. Despite this, disparities in PrEP uptake have worsened over the last decade. Moreover, less than 20% of individuals who could benefit from PrEP are currently taking it. As a result, there have been various attempts to widen access and increase uptake for those in need.
Pharmacists, PrEP, and Practice Policies
In the last couple of years, a long-acting injectable (LAI) version of PrEP has become available, decreasing the burden of daily oral medication while further increasing uptake and disease prevention. Concurrently, numerous states have either introduced or passed legislation expanding the scope of practice of pharmacists. Such legislation explicitly grants pharmacists the authority to prescribe PrEP and/or administer LAIs.
Pharmacist-initiated LAI PrEP has the potential to address the unmet need of HIV prevention in segments of the population that are disproportionately impacted by HIV. Community pharmacies are more abundant, geographically diverse, and have fewer access barriers than primary care facilities and primary care providers. Allowing individuals to access HIV prophylaxis and treatment in community pharmacies could substantially increase PrEP uptake among those who are not yet prescribed it. For these reasons, states are pursuing legislation expanding pharmacists’ scope of practice into HIV care.
First introduced in California and Colorado in 2019, this kind of legislation has led to a growing number of states following suit in hopes to increase HIV prevention. Yet, most states have avoided pursuing this policy change, thereby reinforcing underlying regional disparities in PrEP uptake. Moreover, other interrelated factors — such as insurance coverage, reimbursement, lack of awareness, insufficient facilities/staff, and time constraints — could hinder the legislation’s intended effects.
Notwithstanding these factors, recent research suggests that there are positive outcomes from legislation that affirms pharmacist-initiated LAI PrEP. Within one year, prescription fills for PrEP increased by 24% in states that passed pharmacist prescriber policies for these drugs. Moreover, fills grew by 110% after two years. In states that did not expand pharmacists’ scope of practice, PrEP fills remained largely stagnant. Further research is needed to better understand the impact of this legislation on PrEP uptake and the effects of other factors on it, especially as LAI PrEP becomes increasingly used. Other pre-existing models can offer additional insights.
Community-Based Pharmacy Medication Administration Models
Community pharmacies and pharmacists have played a significant role in expanding access to care — specifically by administering medications. The Albertsons Specialty Care Clinic provides pharmacist-administered LAI antipsychotics in community-based pharmacies, which has successfully expanded access and increased adherence to antipsychotic medication. This model relies on outside providers for prescribing and referring, rather than pharmacists prescribing on site. Nevertheless, this model could be reproduced in the context of HIV prevention with LAI PrEP.
A different model from Bremo Pharmacy in Virginia successfully provided medication administration in a community-based pharmacy during COVID-19. The pharmacy conducted scheduling, informed consent, certain screening through a questionnaire, drug injection, post-administration assessment, and documentation/reporting. Bremo established a collaborative practice agreement with a provider, so that the pharmacists can bill based on their time. Once again, aspects of this model could be utilized for designing community pharmacy-based HIV preventative care through pharmacist-administered LAI PrEP.
In Milwaukee, Hayat Pharmacy has implemented an award-winning and innovative medication administration model. Every month, they are administering up to 30 injections, spanning a range of drugs. Hayat utilizes electronic care (E-care) plans for documentation and follows up with providers in scenarios where a patient has an adverse side effect or requires attention outside of their scope of practice. The E-care plans also keep track of appointments to make sure patients do not miss their injection and use a HIPAA-compliant scheduling system that automatically texts reminders to patients. Hayat is reimbursed by various payers through this model and their pharmacists can earn an administration fee for each injection paid for by the drug manufacturer or by the patient.
Opportunities for Expanding Access to LAI PrEP
In the coming years, there must be clearly defined and integrated legislation that goes beyond merely expanding pharmacists’ scope of practice. This includes addressing the connected issues of insurance and reimbursement, among others, at the onset of any policy change so that the potential for barriers is reduced as much as possible. In designing effective legislation that encourages and facilitates community-based pharmacy care models, states should leverage the lessons and takeaways from the experiences of other practice models.
In recent years, successful models for pharmacist-administered LAI medication services have emerged. While reimbursement and other implementation barriers may still arise, these models have demonstrated a proof-of-concept in the context of psychiatric care that can be translatable. Moving forward, empirical evidence and lessons from these models should be leveraged and inform similar models in HIV preventative care. Understanding these models and factors as interrelated and mutually reinforcing will serve to further remove overall barriers to PrEP access.