Antiretrovirals are used with great success for the treatment of HIV and, increasingly, for its prevention. Because these medications almost always require a prescription, control of the epidemic has progressively come under the purview of a health care system that has myriad problems, including physician shortages.

In this context, community pharmacists have incredible untapped potential. Pharmacies are easily accessible, and pharmacists are often available without appointment. Because pharmacies and pharmacists usually are not linked to specific health conditions, the setting is considered largely free of HIV-related stigma.

We propose expanding pharmacists’ roles in HIV prevention related to preexposure prophylaxis (PrEP) and postexposure prophylaxis (PEP), as well as HIV testing and harm reduction. A role expansion may require (1) working within jurisdictions’ pharmacist scope of practice laws and policies (policy), (2) ensuring appropriate HIV literacy through pharmacist training programs and continuing education courses (education), and (3) building necessary infrastructures with regard to billing and reimbursement, health information technology, and physical settings (infrastructure; See the box on page 860). We share specific recommendations and promising models in each area.

Requirements for Expansion of Pharmacists’ Roles in HIV Prevention
Table
Table
Challenges to Maximizing Pharmacist Potential as Partners in HIV PreventionRecommendations
Policy (i.e., working within jurisdictions’ pharmacist scope of practice laws and policies)Expand CDTM laws to include point-of-care HIV testing and provision of PrEP and PEP medication across all pharmacy practice settings.
Amend jurisdictions’ scope of practice laws and policies to allow pharmacists’ greater involvement in HIV prevention (e.g., prescriptive authority, dispensing medication pursuant to non–patient-specific orders, testing in the pharmacy setting through CLIA waivers).
Conduct and publish more high-quality studies showing pharmacist effect on HIV testing and treatment to inform policy changes.
Education (i.e., ensuring appropriate HIV literacy through pharmacist training programs and continuing education courses)Ensure that other health care providers (e.g., medical doctors, nurse practitioners, physician assistants) are familiar with pharmacists’ training, pharmacists’ scopes of practice, and collaborative practice models (e.g., CDTM).
Standardize recommendations for pharmacy schools’ curricula on HIV management and prevention, including PEP and PrEP.
Develop continuing education courses for practicing pharmacists on HIV management and prevention, including PEP and PrEP.
Infrastructure (i.e., building necessary infrastructures with regard to billing and reimbursement, health information technology, and physical settings)Recognize pharmacists as health care providers who also possess the authority for billing and reimbursement for time and improved patient outcomes.
Expand use of health information technology (e.g., patient portals; read and write access to patient data such as laboratory results, medical history, and primary care provider notes).
Standardize recommendations for documentation, reporting, and management.
Promote inclusion of separate, private space for patient consultation and point-of-care testing in community pharmacy settings.

Note. CDTM = collaborative drug therapy management; CLIA = Clinical Laboratory Improvements Amendment; PEP = postexposure prophylaxis; PrEP = preexposure prophylaxis.

Federal and state laws regulate many HIV prevention activities, and state legislatures, agencies, or boards establish and regulate pharmacists’ scopes of practice. Stakeholders should conduct scans of their state’s response to federal authority over testing and other prevention services and of laws and policies shaping practice.

One type of policy that shapes practice—collaborative drug therapy management (CDTM)—establishes mechanisms for pharmacist-physician partnerships and can be leveraged to create pharmacist-led PrEP clinics. In one pharmacy in Seattle, Washington, pharmacists provide PrEP care in collaboration with a local primary clinic through CDTM.1 Patients access PrEP in one encounter: pharmacists take a history, make a risk assessment, and complete laboratory testing and education before dispensing.2 Pharmacists also conduct follow-up care. The program has served almost 700 patients seeking PrEP care, and 75% of the patients remained engaged after three years.1 Unfortunately, some jurisdictions’ CDTM policies limit practice settings and block pharmacists from medication initiation, effectively precluding similar pilots. However, the hypothetical willingness of some pharmacists to play a larger role in PEP through CDTM2 and the Seattle model suggest that, when possible, similar programs could be launched and further studied to ensure that no negative outcomes are associated with the model.

Non–patient-specific standing orders also can be used to empower pharmacists to dispense HIV prevention medication without direct patient-physician contact. Thirty-one states have already implemented such orders to distribute naloxone for overdose prevention.3 Use of this approach for emergency PEP would improve access, speeding initiation of therapy. As of November 2016, New York State allows pharmacists to dispense up to seven days of PEP through this mechanism.4 Advocacy might convince pharmaceutical companies to prepackage these PEP “starter packs,” potentially facilitating wider access while minimizing waste and financial strain; some insurance plans’ mail-order mandates (that restrict obtaining medication from a community pharmacy) also must be addressed. In January 2019, California lawmakers introduced a bill that would lift the prescription requirement for PrEP and PEP, allowing pharmacists with special training to initiate and dispense the medication.5

Other policy changes are necessary to expand HIV testing and harm reduction in pharmacies. State pharmacy practice acts may require amendment to allow pharmacist provision of point-of-care tests; by federal regulations, such testing may be permissible if the pharmacy has a valid Clinical Laboratory Improvements Amendment (CLIA) Certificate of Waiver and adheres to CLIA regulations. A pilot study in Michigan showed acceptability and feasibility. In jurisdictions where syringe access programs allow for the sale and furnishing of syringes in pharmacies, pharmacists are at the front lines. These jurisdictions should consider supporting more intensive interventions delivered by pharmacists, including education, counseling, and linkage to services, such as in a successful pilot program in New York City that increased use of sterile syringes among drug users.6 Pharmacists should work with their jurisdictions’ health departments, regulatory bodies, and legislators to develop strategies to lift restrictions on syringe access; model legislation should be drafted and best practices identified and disseminated.

As roles in HIV prevention expand, other health care professionals should be aware of how pharmacists can help deliver frontline services mirroring involvement in HIV care.7 Pharmacists should have opportunities to develop a stronger understanding of HIV prevention and management, and integration of related interventions with existing pharmacy business models. Currently, some pharmacy schools offer HIV-specific electives and other experiential opportunities for students, but such offerings are far from universal. The Centers for Disease Control and Prevention also offers training for pharmacists on HIV testing in pharmacies (available at: https://effectiveinterventions.cdc.gov/en/2018-design/hiv-testing/group-1/hiv-testing-in-retail-pharmacies).

Pharmacists should be familiar with their jurisdictions’ HIV-related confidentiality protections, patient record-keeping requirements, and surveillance protocols. Lessons in cultural awareness and sensitivity, and the role of stigma in engagement in care and adherence to medications and appointments, should underpin clinical content. As current opportunities tend to focus more on pharmacotherapy to address the needs of people with HIV, further advocacy is needed to shift toward a more “status-neutral” approach (i.e., one that addresses the needs of those at risk for HIV and those living with HIV).

Pharmacists should be recognized as health care providers and, as such, should have authority to bill for services, including HIV-related counseling. To date, the lack of recognition and the confines of the community pharmacy setting have restricted pharmacist reimbursement for services delivered and access to the information technology and physical space necessary to test and counsel patients effectively or ensure appropriate linkage to care. Billing requires appropriate infrastructure and an understanding of reimbursement codes related to HIV prevention services. This also would necessitate access to patients’ comprehensive medical records. Although the emergence of patient portals and other health information technology has connected many pharmacists to patients’ health records, access across practice settings remains uneven; some community pharmacies may experience financial barriers to accessing these databases and complying with reporting requirements.

Mechanisms for medication reimbursement may actually impede pharmacist involvement in HIV prevention. In the aforementioned pilot program in New York, pharmacists assessed exposure and distributed PEP starter packs as indicated,4 but this required pharmacists to open original containers and dispense medications in other vessels, diminishing the utility of the remaining medication and potentially leading to billing errors, such as being billed for both the starter pack and the remaining medication.

Assessing risk requires screening for sensitive information (e.g., sexual behavior). To facilitate effective counseling, many states legally mandate maintaining a private space for such purposes. With the right incentives aligned, such as scope of practice and reimbursement, community pharmacies lacking such spaces may seek to construct them.

Pharmacists hold a unique position among all health care providers; they are accessible and provide care to individuals with diverse conditions. HIV, with its persistent stigma and associated structural barriers to clinical engagement, presents a prime opportunity for community pharmacist intervention. Many challenges are jurisdiction-specific, including the need for policy change with regard to pharmacists’ scopes of practice, appropriate training of pharmacists in these areas, and further development of the infrastructure necessary to support expansion of practice. When challenges have been addressed, successful programs flourish and stand to benefit their communities, driving new infections down. Although political will and investment may be required, these high-value interventions can effectively address health equity concerns as they prevent disease.

ACKNOWLEDGMENTS

This work was supported by the National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention at the Centers for Disease Control and Prevention (grant NU62PS924575-01-00).

CONFLICTS OF INTEREST

The authors have no conflicts of interest to disclose.

References

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2. Reid AK, Myers JE, Arya V, Edelstein Z. Pharmacist attitudes toward dispensing post-exposure prophylaxis, New York City, 2014. Abstract presented at: New York City Epidemiology Forum; February 27, 2015; New York, NY. Available at: https://www1.nyc.gov/assets/doh/downloads/pdf/dires/reid-nycef.pdf. Accessed December 26, 2018. Google Scholar
3. CVS Health to increase access to FDA-approved nasal naloxone for patients without insurance through improved affordability of NARCAN nasal spray at CVS pharmacy locations [press release]. Woonsocket, RI: CVS Health; July 29, 2016. Available at: https://cvshealth.com/newsroom/press-releases/cvs-health-increase-access-fda-approved-nasal-naloxone-patients-without. Accessed August 12, 2018. Google Scholar
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6. Lewis CF, Rivera AV, Crawford ND, DeCuir J, Amesty S. Pharmacy-randomized intervention delivering HIV prevention services during the syringe sale to people who inject drugs in New York City. Drug Alcohol Depend. 2015;153:7277. Crossref, MedlineGoogle Scholar
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Julie E. Myers, MD, MPH, Davida Farhat, MPH, Adrian Guzman, JD, MPH, and Vibhuti Arya, PharmD, MPHJulie E. Myers, Davida Farhat, and Adrian Guzman are with the Bureau of HIV/AIDS Prevention and Control, New York City Department of Health and Mental Hygiene, Queens, NY. Julie E. Myers is also with the Division of Infectious Diseases, Department of Medicine, Columbia University Vagelos College of Physicians and Surgeons, New York, NY. Vibhuti Arya is with St. John’s University College of Pharmacy and Health Sciences, Queens, NY, and is a clinical advisor to the New York City Department of Health and Mental Hygiene. “Pharmacists in HIV Prevention: An Untapped Potential”, American Journal of Public Health 109, no. 6 (June 1, 2019): pp. 859-861.

https://doi.org/10.2105/AJPH.2019.305057

PMID: 31067105