(1118) Pharmacist Authority to Initiate Prep & PEP and Participate in Collaborative Practice Agreements

Objectives: The aim of this legal research project was to compile enacted state laws and regulations relating to the authority for pharmacists to provide PrEP/PEP related services and participate in collaborative practice agreements (CPAs). The research includes all 50 states, the District of Columbia, and Puerto Rico.

Methods: Research was conducted in the Westlaw state statute and regulation library using the following search terms:
1. pharmac! and (HIV or “human immunodeficiency virus” or AIDS or “acquired immune deficiency syndrome”)
2. pharmac! and (PrEP or “pre-exposure prophylaxis” or PEP or “post-exposure prophylaxis” or Descovy or Apretude or Truvada)
3. pharmac! and (vaccin! or inject!)
4. pharmac! and (“HIV test!” or “hep! test!” or “STD test!” or “sexually transmitted disease test” or “sexually transmitted infection test”)
5. pharmac! and (counsel! or educ! or refer! or “patient navigat!”)
6. pharmac! and (“Clinical Laboratory Improvement Amendments of 1988” or CLIA)
7. pharmac! and “scope of practice”
8. reimburs! and Medicaid and pharmac!
9. reimburs! and insurance and pharmac!

Keyword searches were supplemented by examination of the table of contents of the public health and scope of practice sections of state codes and implementing regulations. Research only included enacted laws and regulations – excluding proposed bills, sub-regulatory guidance, and case law.

Data were collected to identify pharmacists’ ability in each jurisdiction to: 1) initiate PrEP and/or PEP; 2) administer injectable PrEP; 3) independently conduct CLIA-waived tests; 4) be reimbursed for clinical services; and 5) participate in collaborative practice agreements.

Results: After analyzing the laws and regulations for each state, D.C., Puerto Rico, and the Virgin Islands, the following statistics were established:
1) Of the 53 analyzed, 12 jurisdictions address pharmacists’ ability to initiate PrEP and/or PEP. Any additional mandates required of or imposed on the pharmacist by these 12 jurisdictions were addressed in NASTAD’s research.
2) Of the 53 analyzed, 36 jurisdictions grant pharmacists the opportunity to administer injectable PrEP. Any additional mandates required of or imposed on the pharmacist by these 36 jurisdictions were addressed in NASTAD’s research.
3) Of the 53 analyzed, 18 jurisdictions grant pharmacists the opportunity to independently conduct CLIA-waived tests. Any additional mandates required of or imposed on the pharmacist by these 18 jurisdictions were addressed in NASTAD’s research.
4) Of the 53 analyzed, 26 jurisdictions require state Medicaid to reimburse pharmacists for clinical services. Any limitations on reimbursement set by these 26 jurisdictions were addressed in NASTAD’s research.
5) Of the 53 analyzed, 48 jurisdictions grant pharmacists the opportunity to participate in collaborative practice agreements. Any additional mandates required of or imposed on the pharmacist by these 48 jurisdictions were addressed in NASTAD’s research.

Conclusions: Increased uptake of PrEP and PEP to prevent new HIV diagnoses is essential to ending the HIV epidemic. Community pharmacies have great potential to increase uptake as they are accessible healthcare resources that can break down some of the barriers to PrEP and PEP. Granting pharmacists the authority to independently distribute unlimited quantities of PrEP and PEP and establishing legal requirements for proper pharmacist reimbursement are essential to stopping new HIV infections. Furthermore, pharmacists must be able to conduct CLIA-waived tests to effectively provide PrEP. Additionally, where injectable PrEP has been prescribed by a primary care provider, pharmacists need to have the authority to administer the medication. In the absence of accessible PrEP-specific legal authority, however, CPAs can serve as an alternative for pharmacists seeking to initiate PrEP and PEP. By establishing the necessary legal authority, pharmacist-initiated PrEP and PEP promise to be crucial strategies to increase uptake and ultimately end the HIV epidemic.