Advertisement

Community pharmacy delivered PrEP to STOP HIV transmission: An opportunity NOT to miss!

Open AccessPublished:February 01, 2020DOI:https://doi.org/10.1016/j.japh.2020.01.026

      Abstract

      In the United States, 1.1 million persons are living with human immunodeficiency virus (HIV), and approximately 37,800 new infections occur annually. Ending the HIV epidemic requires reducing HIV transmissions by 90% within the next 10 years and requires expanded HIV testing, antivirals for persons infected with HIV, and scale-up of pre-exposure prophylaxis (PrEP) and postexposure prophylaxis (PEP) to prevent new infections. Community pharmacies are widely accessible and employ highly trained health care professionals on-site who can initiate PrEP and PEP. Recommendations are offered to implement a community pharmacy PrEP program. Pharmacy, government, and HIV prevention leaders must be prepared to support and promote transformative changes, including (1) modification or expansion of existing state-specific scope of practice to initiate PrEP and PEP, (2) encouraging pharmacist education about PrEP and PEP, (3) identification and screening of candidates for PrEP eligibility, (4) incorporating pharmacy laboratory ordering and monitoring logistics, (5) adjusting workflow and ensuring confidential spaces for sensitive discussions, and (6) addressing reimbursement to maintain pharmacist-delivered PrEP and PEP programs. HIV disproportionately affects minority communities and younger individuals who may not be engaged in the health care system. Community pharmacies are accessible and can help increase PrEP use. Expansion of community pharmacy PrEP programs are needed to help end the HIV epidemic. Implementation of PrEP requires adaptation of the pharmacy profession to support incorporation of PrEP in a community pharmacy. Endorsement and support of community pharmacists are needed to implement PrEP to increase HIV prevention efforts and expand pharmacists’ scope of practice.

       Background

      • Decreasing human immunodeficiency virus (HIV) transmission is a national goal.
      • Despite efficacy and safety of pre-exposure prophylaxis (PrEP), use is low in those most at risk of acquiring HIV, including Blacks or African Americans, Latinos, and younger persons.
      • Because of their accessibility, community pharmacies and pharmacists have the potential to increase PrEP and postexposure prophylaxis (PEP), especially in persons not engaged in the health care system.
      • Two community pharmacy programs have demonstrated feasibility of pharmacist-initiated PrEP, and California’s new law, SB159, will soon allow community pharmacists to initiate PrEP and PEP.

       Findings

      • There is a need for pharmacists to receive additional training on HIV prevention to provide effective PrEP and PEP delivery.
      • To implement an effective community pharmacy PrEP and PEP program, leaders should be prepared to increase pharmacists’ PrEP and PEP education and incorporate ordering and monitoring of laboratory tests, workspace, and workflow changes as appropriate to their site.
      In the United States, there are 1.1 million persons living with human immunodeficiency virus (HIV) and approximately 37,800 new annual infections.
      U.S. Department of Health & Human Services
      Overview: data & trends: U.S. statistics.
      In 2019, the White House announced Ending the HIV Epidemic, which will work to reduce HIV transmissions by 75% and 90% within 5 and 10 years, respectively.
      • Azar A.
      Ending the HIV epidemic: a plan for America.
      Offering early HIV testing, antiretroviral treatment for persons infected with HIV, pre-exposure prophylaxis (PrEP) and postexposure prophylaxis (PEP) for persons who tested negative and are at a high risk for HIV are the key drivers of success in the national plan to end the HIV epidemic.
      • Azar A.
      Ending the HIV epidemic: a plan for America.
      Pharmacies are widely distributed in communities, have earned community trust, and have highly trained health care professionals available to increase PrEP and PEP uptake in persons who may be at the highest risk of acquiring HIV.
      PrEP is safe, effective, and strongly recommended.
      Centers for Disease Control and Prevention
      US Public Health Service: preexposure prophylaxis for the prevention of HIV infection in the United States—2017 update: a clinical practice guideline.
      World Health Organization
      WHO expands recommendation of oral pre-exposure prophylaxis of HIV infection (PrEP).
      • Owens D.K.
      • Davidson K.W.
      • et al.
      U.S. Preventive Services Task Force
      Preexposure prophylaxis for the prevention of HIV infection: US preventive services task force recommendation statement.
      A single tablet of fixed dose tenofovir disoproxil fumarate/emtricitabine (F/TDF) was approved by the Food and Drug Administration (FDA) as PrEP for HIV prevention in 2012.
      Centers for Disease Control and Prevention
      CDC statement on FDA approval of drug for HIV prevention.
      Evidence of F/TDF PrEP safety and efficacy was first published in 2010 and endorsed by the Centers for Disease Control and Prevention (CDC) the following year.
      • Grant R.M.
      • Lama J.R.
      • Anderson P.L.
      • et al.
      Preexposure chemoprophylaxis for HIV prevention in men who have sex with men.
      ,
      Centers for Disease Control and Prevention (CDC)
      Interim guidance: preexposure prophylaxis for the prevention of HIV infection in men who have sex with men.
      Alternative drug regimens and dosing strategies have emerged for select populations, including a coformulation of emtricitabine with tenofovir alafenamide (F/TAF), which was approved for PrEP by the FDA in late 2019 on the basis of a single trial involving men who have sex with men and transgender women.
      U.S. Food and Drug Administration
      FDA approves second drug to prevent HIV infection as part of ongoing efforts to end the HIV epidemic.
      ,

      Hare CB, Coll J, Ruane P, et al. The phase 3 DISCOVER study: daily F/TAF or F/TDF for HIV preexposure prophylaxis. Abstract 104. Presented at the 26th Conference on Retroviruses and Opportunistic Infections, Seattle, WA; March 4-7, 2019.

      Emtricitabine plus tenofovir alafenamide was not approved for persons at risk from receptive vaginal sex, including women and transgender men.
      U.S. Food and Drug Administration
      FDA approves second drug to prevent HIV infection as part of ongoing efforts to end the HIV epidemic.
      Both F/TDF and F/TAF have low rates of clinical adverse events when used as PrEP.

      Hare CB, Coll J, Ruane P, et al. The phase 3 DISCOVER study: daily F/TAF or F/TDF for HIV preexposure prophylaxis. Abstract 104. Presented at the 26th Conference on Retroviruses and Opportunistic Infections, Seattle, WA; March 4-7, 2019.

      ,
      • Fonner V.A.
      • Dalglish S.L.
      • Kennedy C.E.
      • et al.
      Effectiveness and safety of oral HIV preexposure prophylaxis for all populations.
      The newer formulation, F/TAF, appears to have less bone and kidney effects, although the clinical significance of these differences is unknown.

      Hare CB, Coll J, Ruane P, et al. The phase 3 DISCOVER study: daily F/TAF or F/TDF for HIV preexposure prophylaxis. Abstract 104. Presented at the 26th Conference on Retroviruses and Opportunistic Infections, Seattle, WA; March 4-7, 2019.

      In addition, F/TAF has some metabolic changes in weight gain and increased low-density lipoprotein; the long-term safety of F/TAF needs further study.
      • Buti M.
      • Gane E.
      • Seto W.K.
      • et al.
      Tenofovir alafenamide versus tenofovir disoproxil fumarate for the treatment of patients with HBeAg-negative chronic hepatitis B virus infection: a randomised, double-blind, phase 3, non-inferiority trial.
      ,
      • Hill A.
      • Waters L.
      • Pozniak A.
      Are new antiretroviral treatments increasing the risks of clinical obesity?.
      A start-up syndrome involving mild nausea, abdominal cramping, or headache can occur with either F/TDF or F/TAF and is usually self-limited.
      Centers for Disease Control and Prevention
      US Public Health Service: preexposure prophylaxis for the prevention of HIV infection in the United States—2017 update: a clinical practice guideline.
      ,

      Hare CB, Coll J, Ruane P, et al. The phase 3 DISCOVER study: daily F/TAF or F/TDF for HIV preexposure prophylaxis. Abstract 104. Presented at the 26th Conference on Retroviruses and Opportunistic Infections, Seattle, WA; March 4-7, 2019.

      Both the World Health Organization and the CDC support the use of TDF monotherapy, which has been studied and shown to be effective in heterosexual men and women and persons who inject drugs.
      World Health Organization
      WHO expands recommendation of oral pre-exposure prophylaxis of HIV infection (PrEP).
      ,
      • Owens D.K.
      • Davidson K.W.
      • et al.
      U.S. Preventive Services Task Force
      Preexposure prophylaxis for the prevention of HIV infection: US preventive services task force recommendation statement.
      For men who have sex with men, an alternative dosing strategy using F/TDF PrEP is known to be effective when 2 tablets are taken before sex, and 1 tablet is taken daily for 2 days after sex, so called “on-demand” or “2-1-1” dosing.

      Molina JM, Tremblay C, Charreau I, et al. On-demand PrEP with TDF/FTC remains highly effective among MSM with infrequent sexual intercourse: a sub-study of the ANRS IPERGAY trial. Abstract 3629. Presented at the 9th Conference for the International AIDS Society, Paris, France; July 23-26, 2017. Available at: http://programme.ias2017.org/Abstract/Abstract/3629. Accessed January 12, 2020.

      This 2-1-1 dosing strategy is endorsed by the World Health Organization and the International Antiviral Society–USA for men who have sex with men; the drug manufacturer has not submitted this evidence for FDA review in the United States.
      • Saag M.S.
      • Benson C.A.
      • Gandhi R.T.
      • et al.
      Antiretroviral drugs for treatment and prevention of HIV infection in adults: 2018 recommendations of the International Antiviral Society–USA Panel.
      ,
      World Health Organization
      WHO endorses event driven PrEP for gay men.
      It is estimated that less than 10% of people who would benefit from PrEP are receiving the medication.
      • Siegler A.J.
      • Mouhanna F.
      • Giler R.M.
      • et al.
      The prevalence of pre-exposure prophylaxis use and the pre-exposure prophylaxis-to-need ratio in the fourth quarter of 2017, United States.
      Uptake of PrEP in San Francisco, CA, and New York reached a tipping point in late 2013 after results of the nearly complete protection observed among adherent PrEP users was publicized on social media.
      • Volk J.E.
      • Marcus J.L.
      • Phengrasamy T.
      • et al.
      No new HIV Infections with increasing use of HIV preexposure prophylaxis in a clinical practice setting.
      ,
      • Anderson P.L.
      • Glidden D.V.
      • Liu A.
      • et al.
      Emtricitabine-tenofovir concentrations and pre-exposure prophylaxis efficacy in men who have sex with men.
      Use of PrEP continues to occur primarily in well-resourced cities (i.e., San Francisco), where HIV incidence is declining.
      San Francisco Department of Public Health
      HIV epidemiology annual report 2018.
      By contrast, HIV transmission rates are increasing in other areas, such as the rural south, where PrEP uptake is the lowest.

      Sullivan PS, Smith DK, Giler RM, et al. The impact of pre-exposure prophylaxis with FTC/TDF on HIV diagnoses, 2012-2016, United States. Abstract LBPEC036. Presented at 22nd International AIDS Conference, Amsterdam, the Netherlands; July 24-27, 2018.

      ,

      Smith DK, Van Handel M, Grey JA. By race/ethnicity, blacks have highest number needing PrEP in the United States. Abstract 86. Presented at Conference on Retroviruses and Opportunistic Infections, Boston, MA; March 4-7, 2018.

      Barriers to PrEP uptake include lack of awareness by communities and providers, preauthorization requirements that are driven by high prices, and low access to health care services because of shortages of general prescribers and sexual health services.
      • Calabrese S.K.
      • Magnus M.
      • Mayer K.H.
      • et al.
      Putting PrEP into practice: lessons learned from early-adopting U.S. providers’ firsthand experiences providing HIV pre-exposure prophylaxis and associated care.
      High drug prices that prompt preauthorization requirements are a barrier to access. The wholesale acquisition cost of brand F/TDF and F/TAF is $1842.28 per person per month in the United States.
      Micromedix drug pricing.
      Generic F/TDF is expected to enter the U.S. market in September 2020, and prices may fall toward the generic F/TDF pricing available in global markets at a median $6.50 per person per month.
      Gilead Sciences
      United States Securities and Exchange Commission. Washington, D.C. Form10-Q, page 35.
      ,
      World Health Organization
      Global price reporting mechanism.
      Dissemination of innovations, including PrEP, require flexibility, reinvention, and local leadership.
      • Berwick D.M.
      Disseminating innovations in health care.
      With more than 60,000 community pharmacies in the United States, community pharmacies are ideal locations to reduce barriers to PrEP uptake.
      • Qato D.M.
      • Zenk S.
      • Wilder J.
      • Harrington R.
      • Gaskin D.
      • Alexander G.C.
      The availability of pharmacies in the United States: 2007–2015.
      Expanding PrEP into community pharmacies is important for HIV prevention. HIV disproportionately affects vulnerable communities, including Latinx/Latinos/Hispanics, Blacks or African Americans, and younger persons, who might not be engaged in regular medical care and show less PrEP uptake.
      Centers for Disease Control and Prevention
      Estimated HIV incidence and prevalence in the United States 2010–2016.
      ,
      Centers for Disease Control and Prevention
      HIV prevention pill not reaching most Americans who could benefit-especially people of color.
      Community pharmacies are accessible, provide convenient and longer store hours, are staffed by pharmacists who know the medications, maintain established relationships within the community, and can offer immediate PrEP, other medications, and additional on-site patient care services (e.g., adherence counseling, vaccinations, oral contraceptives, cholesterol, and other point-of-care testing).
      National Alliance of State Pharmacy Associations
      Pharmacist prescribing: hormonal contraceptives.
      ,
      American Pharmacists Association
      Pharmacists Provide Care: pharmacist scope of services factsheet.
      The convenient hours and open-door availability of community pharmacies have been shown to increase the likelihood of HIV testing in priority areas with HIV disparities, which is a key requirement for safe PrEP uptake.
      • Collins B.
      • Bronson H.
      • Elamin F.
      • Yerkes L.
      • Martin E.
      The “no wrong door approach” to HIV testing: results from a statewide retail pharmacy-based HIV testing program in Virginia, 2014-2016.

      Objective

      The objective of this commentary is to encourage key stakeholders to advocate for implementing community pharmacy–initiated PrEP and provide recommendations for implementing PrEP in a community pharmacy.

      Summary

      California’s newest landmark legislation, SB159, mandates a state protocol for pharmacists to initiate (prescribe) and furnish PrEP and PEP.
      • Gardiner D.
      Gavin Newsom signs bill to make anti HIV drug available without prescription.
      This law was broadly supported and is intended to increase HIV prevention efforts in California. For ease of discussion, we refer to community pharmacy PrEP to mean a “community pharmacy PrEP program” and recommend such programs should offer both PrEP and PEP. Persons who present for PrEP may actually need PEP, and clinicians should provide PEP when indicated. Importantly, PEP must be started as soon as possible, but no later than 72 hours after the potential exposure, supporting the need for community models with immediate access to the medications.
      Centers for Disease Control and Prevention
      Updated guidelines for antiretroviral postexposure prophylaxis after sexual, injection drug use, or other nonoccupational exposure to HIV–United States, 2016.
      Except for minor differences in medications and testing, community pharmacy PrEP implementation is similar when offering PrEP or PEP. Medication options for PEP are several and not discussed in this commentary. Pharmacists interested in providing PrEP or PEP should seek additional training to provide expert care. Implementation of PrEP and PEP in community pharmacies requires adaptation and a commitment to change. Whereas industry changes can be challenging, emerging business and health care trends require community pharmacies to adapt and develop effective new models of pharmacy care delivery. Community pharmacy leaders, administrators, and pharmacists should be prepared to acknowledge and accept that PrEP implementation in their community pharmacy might bring unique challenges that can be addressed. Table 1 summarizes recommendations, and Table 2 lists several resources for implementing PrEP.
      Table 1Recommendations for implementing a community PrEP program
      Suggested areasRecommended tasks
      Develop a collaborative practice agreement or state protocol
      • -
        Provide pharmacists prescriptive authority to initiate and dispense PrEP and PEP prescriptions, order required laboratory tests (STI testing, serum creatinine, hepatitis B serology, hepatitis C)
      • -
        Provide pharmacist autonomy
      Set up laboratory logistics on-site or for send out laboratory tests
      • -
        Order CLIA-waived rapid tests
      • -
        Providing pharmacy space for collecting laboratory specimens
      • -
        Training staff on specimen collection and handling on-site (“one stop PrEP”) or off-site
      • -
        Consider on-site phlebotomist
      • -
        Refer patient to outside laboratory
      • -
        Access to laboratory test results
      Obtain medical and sexual health history and assessment
      • -
        Develop intake questionnaire to collect medical history, sexual and drug use (if applicable), medication history, indications and potential contraindications for PrEP and PEP
      • -
        Provide harm reduction counseling
      • -
        Provider referrals (if appropriate) for active STI, HBV, HCV, opiate treatment or other medical condition that is suspected (i.e., high blood pressure, etc.)
      Adapt pharmacy workflow and space
      • -
        Establish confidential spaces for sensitive history taking, testing, and discussion of test results
      • -
        Consider installing modular ready counseling rooms for privacy
      • -
        Assign specific pharmacy staff to PrEP to accommodate walk-in requests
      Establish methods of communication
      • -
        Determine how important and confidential information will be shared among team members, patients, and referring providers or health departments
      • -
        Set up online portals, secure e-mails, text messages, apps, and shared EMRs, which can save time
      Provide and monitor pharmacist education and on-hands training, including training of any auxiliary staff
      • -
        Set up pharmacist specific training program, and as appropriate, auxiliary staff training
      • -
        Pharmacists should demonstrate competency on HIV infection and the use and delivery of safe and effective PrEP and PEP per national guidelines, counseling on sexual health and comprehensive prevention strategies, especially for diverse populations who are at risk of HIV acquisition, performing laboratory tests and its proper laboratory interpretation, PrEP benefits navigation (aka coordination of benefits), including the use of manufacturer assistance programs or other free programs to reduce cost barriers for PrEP.
      • -
        Set realistic time goals for patient visits, medical charting, and implementation of new work processes.
      • -
        Provide feedback and ongoing training and monitoring
      Identify reimbursement strategies
      • -
        Determine state reimbursement laws; modify existing laws if necessary
      • -
        Consider grant funding, 340B contracts, direct negotiation with insurance contracts
      • -
        Continue advocacy at the national level for recognition of provider status
      Abbreviations used: CLIA, Clinical Laboratory Improvement Amendments; EMR, electronic medical record; HBV, hepatitis B virus; HCV, hepatitis C virus; PrEP, pre-exposure prophylaxis; PEP, postexposure prophylaxis; STI, sexually transmitted infection.
      Table 2Selected community pharmacy PrEP resources
      ResourceContact information
      Community pharmacy PrEP-CPhA informational CE video (conversation with R.M.G. and M.I.L.)https://cpha.com/ce-events/on-demand-courses/community-pharmacists-provide-prep/ (CE version)  https://m.youtube.com/watch?feature=youtu.be&v=s7XcO2oD1vY (non CE, free version)
      CDC Guidelines for PrEP and PEPhttps://www.cdc.gov/hiv/guidelines/preventing.html

      PrEP for the prevention of HIV infection in the United States—2017 Update: a clinical practice guideline.

      Updated guidelines for antiretroviral PEP after sexual, injection drug use, or other nonoccupational exposure to HIV-United States, 2016
      WHO PrEP implementation toolkithttps://www.who.int/hiv/pub/prep/prep-implementation-tool/en/
      Constructing collaborative practice agreementshttps://cpha.com/ce-events/on-demand-courses/cpa/https://www.aphafoundation.org/collaborative-practice-agreements/
      AIDS education and training resourceshttps://aidsetc.org/topics
      New York state department of health AIDS Institute PrEP guidelineshttps://www.hivguidelines.org/prep-for-prevention/
      University of Washington training modulesNational HIV Curriculum by the University of Washington, including PrEP and PEP https://www.hiv.uw.edu/National STD Curriculum by the University of Washington https://www.std.uw.edu/National Hepatitis training module https://www.hepatitisc.uw.edu/
      Clinical consultation on PrEP and PEPClinician Consultation Service (https://nccc.ucsf.edu/) provide links to PrEP and PEP resources.

      Direct clinical consultation on PrEP and PEP, provided free by clinicians, is available by calling the PrEP line at 1-888-448-4911 (Monday–Friday, 9 AM–8 AM ET) and PEPLINE at 1-855- 448-7737 (daily 11 AM–8 PM ET)
      CDC CLIA-waived testinghttps://www.cdc.gov/labquality/waived-tests.html?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fclia%2Fwaived-tests.html
      Liverpool HIV drug interactionshttps://www.hiv-druginteractions.org/
      CDC national PrEP locatorhttps://npin.cdc.gov/preplocator
      PrEP locator and databasehttps://www.pleaseprepme.org/
      PrEP resources and capacity building assistancehttps://wwwn.cdc.gov/CTS

      Contact: [email protected]

      San Francisco Department of Health Capacity Building Assistance https://getsfcba.org
      Abbreviations used: AIDS, acquired immunodeficiency syndrome; HIV, human immunodeficiency virus; CDC, Centers for Disease Control and Prevention; CE, continuing education; CLIA, Clinical Laboratory Improvement Amendments; CPhA, California Pharmacists Association; ET, Eastern time; PEP, postexposure prophylaxis; PrEP, pre-exposure prophylaxis; STD, sexually transmitted disease; WHO, World Health Organization.

       Lessons learned from existing community pharmacy models of PrEP initiation

      Under collaborative practice, pharmacists in clinical settings (e.g., ambulatory care or hospital) initiate, modify, and discontinue a number of medications, including PrEP. Several models describe pharmacists’ collaboration with clinics to initiate PrEP.
      • Hoth A.
      • Shafer C.
      • Dillon D.
      • et al.
      Iowa TelePrEP: preliminary experience with a public health-partnered, telemedical PrEP delivery model in a rural state.

      Keenan R, Lewis J, Sanchez D, et al. The next step in PrEP: evaluating outcomes of a pharmacist-run HIV pre-exposure prophylaxis (PrEP) clinic. Abstract 1293. Presented at ID Week Conference; San Francisco, CA: October 3-7, 2018.

      • Havens P.J.
      • Scarsi K.K.
      • Sayles H.
      • et al.
      Acceptability and feasability of a pharmacist-HIV pre-exposure prophylaxis (PrEP) program in the midwestern United States.
      • Dong J.B.
      • Grant M.R.
      • Lopez I.M.
      Response to: Acceptability and feasability of a pharmacist-led HIV pre-exposure prophylaxis (PrEP) program in the midwestern United States..
      Recently, 2 published models in Seattle, WA, and San Francisco (SF), CA, have demonstrated that pharmacists’ initiation of PrEP in the community pharmacy setting can be successful.
      • Tung E.L.
      • Thomas A.
      • Eichner A.
      • Shalit P.
      Implementation of a community pharmacy-based pre-exposure prophylaxis service: a novel model for pre-exposure prophylaxis care.
      ,
      • Lopez M.I.
      • Cocohoba J.M.
      • Cohen S.E.
      • Trainor N.
      • Levy M.M.
      • Dong B.J.
      Implementation of pre-exposure prophylaxis at a community pharmacy through a collaborative practice agreement with San Francisco department of public health.
      The Seattle, WA, site uses a collaborative drug therapy agreement and has received financial reimbursement for initiating PrEP in more than 700 patients. The SF model operates under a collaborative practice agreement with the SF Department of Public Health to provide PrEP and PEP and was instrumental in the passage of SB159. In both of these models, the community pharmacists have the prescriptive authority to order the initial and ongoing PrEP prescriptions, obtain initial HIV and other sexually transmitted infection (STI) screening tests, have access to these laboratory test results, dispense the PrEP immediately, perform adherence counseling, and conduct follow-up monitoring. The autonomy of these pharmacists in these aforementioned models may have removed previous logistic barriers. Community pharmacists have a proven track record in the safe and effective provision of preventive care, including vaccines and contraception, therefore extending their autonomy to include PrEP is warranted.
      • Patel A.R.
      • Breck A.B.
      • Law M.R.
      The impact of pharmacy-based immunization services on the likelihood of immunization in the United States.
      ,
      • Lu S.
      • Rafie S.
      • Hamper J.
      • Strauss R.
      • Kroon L.
      Characterizing pharmacist-prescribed hormonal contraception services and users in California and Oregon pharmacies.
      Securing access to laboratory test results in the community pharmacy setting is an important milestone, especially because most community pharmacies do not have access to the electronic medical record.
      • van Lint J.A.
      • Sorge L.A.
      • Sorensen T.D.
      Access to patients’ health records for drug therapy problem determination by pharmacists.
      Community pharmacists can provide rapid CLIA (Clinical Laboratory Improvement Amendments)-waived tests (e.g., HIV, hepatitis C, serum creatinine, syphilis).
      U.S. Food and Drug Administration
      CLIA–clinical laboratory improvement amendments–currently waived analytes.
      An excellent example of HIV testing in pharmacies is described by Collins et al.
      • Collins B.
      • Bronson H.
      • Elamin F.
      • Yerkes L.
      • Martin E.
      The “no wrong door approach” to HIV testing: results from a statewide retail pharmacy-based HIV testing program in Virginia, 2014-2016.
      Although the SF program has a phlebotomist, who also serves as a pharmacy technician, other pharmacies could refer out laboratory testing to reference laboratories, which is how PrEP is offered in many medical settings today. Having specimen collection on-site allows for “one stop” PrEP, which is convenient, although it requires a private room, specimen collection equipment, and a chair. Modular ready-to-install counseling rooms can be a solution for pharmacies looking to easily install a small private room.
      • Levy S.
      Flipping the script: the state of the pharmacy industry.
      Such rooms are also useful for providing confidentiality while discussing sensitive sexual history taking and drug use. National trends in chain pharmacies indicate expansion into the patient care footprint, including the addition of mini-clinics and laboratories, which should increase access to phlebotomy and other laboratory services in pharmacy settings.
      • Bannow T.
      CVS to aggressively expand healthcare services in stores.
      ,
      Walgreens Newsroom
      Walgreens and LabCorp to open at least 600 labcorp at Walgreens patient service centers.
      The community pharmacist should confirm that the patient has a negative HIV test within 7 days and before starting PrEP. The patient can bring in the results of the HIV test, or a rapid HIV finger-stick blood test can be conducted at the pharmacy. Proof of hepatitis B immunity and screening for hepatitis C, STI (e.g., gonorrhea, chlamydia, and syphilis), and serum creatinine are recommended for PrEP services, although the results of these tests are not required before initiation of PrEP.
      Centers for Disease Control and Prevention
      US Public Health Service: preexposure prophylaxis for the prevention of HIV infection in the United States—2017 update: a clinical practice guideline.
      Regular STI screening should be routinely completed for all persons on PrEP in accordance with CDC guidelines.
      Centers for Disease Control and Prevention
      US Public Health Service: preexposure prophylaxis for the prevention of HIV infection in the United States—2017 update: a clinical practice guideline.
      Patients can be taught to self-collect STI specimens for sending out or go to a nearby lab site for STI tests. Procedures for patient referral for medical care or on-site treatment should be available for all patients with preliminary positive test results or diagnosed with active STI or hepatitis B or C infections.
      If pharmacies elect to collect blood and STI specimens, they will need to incorporate and integrate new and existing processes for handling laboratory specimens, using medical settings as models. One recommendation for simplifying logistics for laboratory tests’ couriers is to incorporate these with pre-existing medication delivery services. Nationally, most independent community pharmacies provide same-day delivery, and 2 major chains recently began to provide courier delivery services for medications.
      Pharmacy Times
      2018 digest: community pharmacy 35% of retail pharmacy space.
      • Gopisetty D.
      • Kurian M.
      CVS announces same day home delivery of prescriptions.
      • Al-Muslim A.
      Walgreens launches next-day prescription home delivery with FedEx.
      Collecting a sexual and drug history, a medication history for potential drug interactions, and a medical history for possible renal disease before starting PrEP can be completed by an intake questionnaire that the pharmacist reviews. The pharmacist should also rule out symptoms of acute HIV. Most persons who need PrEP are relatively young and healthy with a low risk of renal dysfunction. Questions such as, “Have you ever had a condition that affected your kidneys, a history of high blood pressure, etc.?” can screen for the possibility of pre-existing renal disease. Mikati et al.

      Mikati T, Jamison K, Daskalakis DC. Immediate PrEP initiation at New York city health clinics. Abstract 962. Paper presented at 26th Conference on Retroviruses and Opportunistic Infections, Seattle, WA; March 4-7, 2019.

      used similar screening questions at a PrEP clinic in New York City, NY, and found that most of the patients (97%) could start PrEP immediately.

      Mikati T, Jamison K, Daskalakis DC. Immediate PrEP initiation at New York city health clinics. Abstract 962. Paper presented at 26th Conference on Retroviruses and Opportunistic Infections, Seattle, WA; March 4-7, 2019.

      For persons who are later found to have baseline renal insufficiency, it is important that they are contacted within a few days of their elevated baseline serum creatinine test results. Under these circumstances, a repeat serum creatinine test is recommended (to confirm unexpected elevations) and if confirmed, the person should be referred to a medical provider.
      The disruption of pharmacy workflow could be a concern. However, such logistical concerns are common with implementation of new pharmacy services, such as vaccinations, blood pressure screenings, and laboratory testing. Community pharmacies can adapt workflow changes in a similar manner. It is best to devote staff who are not working on time sensitive preparation of medications to accommodate walk-in patients requesting PrEP. For example, staff devoted to medication therapy management and refills (future fills) are used in the PrEP program at the SF site. During implementation, it may take staff longer to finish tasks, but efficiency should improve with increased experience. Realistic time goals for patient visits and medical charting need to be established so that PrEP staff have reasonable expectations and can adjust to the new workflows.
      Community pharmacies are often separated from integrated health care systems; hence they require the establishment of partnerships for referring patients to ongoing care or to create collaborative practice agreements. Both the Seattle, WA, and SF models were able to implement shared electronic medical records at their sites. In the SF model, laboratory test results are obtained from a combination of faxes and shared electronic portal with the county health department. Many community pharmacies already use telephone calls and text messaging for refill reminders. Other time saving options for sharing of information between providers and patients include the use of secure e-mail, text messages, cell phone apps, online portals, and traditional faxes.
      Pharmacy staff, similar to other medical providers, need training on PrEP, as demonstrated in several surveys.
      • Okoro O.
      • Hillman L.
      HIV pre-exposure prophylaxis: exploring the potential for expanding the role of pharmacists in public health.
      ,
      • Shaeer K.M.
      • Sherman E.M.
      • Shafiq S.
      • Hardigan P.
      Exploratory survey of Florida pharmacists’ experience, knowledge, and perception of HIV pre-exposure prophylaxis.
      Education should include application of the CDC PrEP (and PEP) protocols and guidelines, proper interpretation of laboratory test results, evaluation of potential drug interactions, counseling, monitoring, and follow-up. Although pharmacy school curriculum already includes interpretation of laboratory test results, competency in application is necessary and can be completed by developing a pharmacists’ PrEP continuing education curriculum that includes didactic and clinical training in the delivery of PrEP. Training in the delivery of CLIA-waived tests or other laboratory procedures can be included for those sites electing to have on-site testing. Training on history taking, communicating sensitive test results, and maintaining cultural sensitivity, especially in populations most at risk is warranted. Education about PrEP benefits navigation (i.e., coordination of benefits), including the use of manufacturer assistance programs to reduce cost barriers for PrEP, is necessary. Non-PrEP staff should receive training on assisting pharmacy patients who inquire about PrEP and PEP. On the basis of a study of community pharmacists, online training is preferred.
      • Okoro O.
      • Hillman L.
      HIV pre-exposure prophylaxis: exploring the potential for expanding the role of pharmacists in public health.
      Obtaining reimbursement to cover program costs can be a challenge, especially because pharmacists are not recognized as providers at the national level through the Centers for Medicare and Medicaid Services.
      • Gebhart F.
      On the road to provider status.
      Both the SF and Seattle sites were able to secure funding, which was key in their ability to provide PrEP services.
      • Havens P.J.
      • Scarsi K.K.
      • Sayles H.
      • et al.
      Acceptability and feasability of a pharmacist-HIV pre-exposure prophylaxis (PrEP) program in the midwestern United States.
      ,
      • Dong J.B.
      • Grant M.R.
      • Lopez I.M.
      Response to: Acceptability and feasability of a pharmacist-led HIV pre-exposure prophylaxis (PrEP) program in the midwestern United States..
      California’s SB159 mandates to reimburse pharmacists for initiating and furnishing PrEP and PEP, but will cover only a portion of the population.
      American Pharmacists Association
      Pharmacists Provide Care: pharmacist scope of services factsheet.
      The California bill will reimburse at 85% of the physician rate, potentially saving health care costs. In 2016, Washington state set the gold standard for pharmacists’ reimbursement when it passed landmark legislation, SB5557, which requires insurance plans to reimburse and recognize pharmacists as providers.
      University of Washington
      SB5557 expands patient care access in Washington.
      Similar reimbursement legislation has also been passed in Texas and Tennessee, paving the way for pharmacies in those states to bill for clinical services and potentially offer both PrEP and PEP.
      • Balick R.
      Tennessee is second state to credential and reimburse pharmacists as providers.
      ,
      • Bonner L.
      Texas pharmacists now providers in private health plans.
      Other means of revenue could come from contracts with 340B clinics (a government-mandated drug price rebate program for safety net providers), grant funding, and direct insurance contracts with employer groups and universities. Financial reimbursement is required for pharmacists and pharmacies to devote time and resources to these critical services, including focused counseling, confidential pharmacy space, and laboratory testing. Demonstrating pharmacists’ success in providing preventive care in accessible and cost-effective ways will motivate government and health care organizations to ensure funding, similar to how vaccines and other pharmacy services have demonstrated success. Patient advocacy groups were critical to the success of SB159 in California and can also promote and urge for increased access and availability to PrEP delivery services outside of traditional medical facilities.

      Conclusion

      Ending the HIV epidemic will require innovative models to increase early testing and treatment, in addition to offering PrEP and PEP in an accessible manner. Embedded in the community, community pharmacies have access to persons who may be at risk of acquiring HIV and not currently engaged in the health care system. Community pharmacies serve a foundational role in taking PEP and PrEP off the shelf and putting it in the hands of people who may be exposed to HIV infection. Although providing community pharmacy PrEP services offers some new challenges, community pharmacists now are afforded a tremendous patient care opportunity to apply their training and clinical expertise in order to practice at the top of their profession and stop the HIV epidemic.

      References

        • U.S. Department of Health & Human Services
        Overview: data & trends: U.S. statistics.
        (Available at:)
        • Azar A.
        Ending the HIV epidemic: a plan for America.
        (Available at:)
        • Centers for Disease Control and Prevention
        US Public Health Service: preexposure prophylaxis for the prevention of HIV infection in the United States—2017 update: a clinical practice guideline.
        (Available at:)
        • World Health Organization
        WHO expands recommendation of oral pre-exposure prophylaxis of HIV infection (PrEP).
        (Available at:)
        • Owens D.K.
        • Davidson K.W.
        • et al.
        • U.S. Preventive Services Task Force
        Preexposure prophylaxis for the prevention of HIV infection: US preventive services task force recommendation statement.
        JAMA. 2019; 321: 2203-2213
        • Centers for Disease Control and Prevention
        CDC statement on FDA approval of drug for HIV prevention.
        (Available at:)
        • Grant R.M.
        • Lama J.R.
        • Anderson P.L.
        • et al.
        Preexposure chemoprophylaxis for HIV prevention in men who have sex with men.
        N Engl J Med. 2010; 363: 2587-2599
        • Centers for Disease Control and Prevention (CDC)
        Interim guidance: preexposure prophylaxis for the prevention of HIV infection in men who have sex with men.
        MMWR Morb & Mortal Wkly Rep. 2011; 60: 65-68
        • U.S. Food and Drug Administration
        FDA approves second drug to prevent HIV infection as part of ongoing efforts to end the HIV epidemic.
        (Available at:)
      1. Hare CB, Coll J, Ruane P, et al. The phase 3 DISCOVER study: daily F/TAF or F/TDF for HIV preexposure prophylaxis. Abstract 104. Presented at the 26th Conference on Retroviruses and Opportunistic Infections, Seattle, WA; March 4-7, 2019.

        • Fonner V.A.
        • Dalglish S.L.
        • Kennedy C.E.
        • et al.
        Effectiveness and safety of oral HIV preexposure prophylaxis for all populations.
        AIDS. 2016; 30: 1973-1983
        • Buti M.
        • Gane E.
        • Seto W.K.
        • et al.
        Tenofovir alafenamide versus tenofovir disoproxil fumarate for the treatment of patients with HBeAg-negative chronic hepatitis B virus infection: a randomised, double-blind, phase 3, non-inferiority trial.
        Lancet Gastroenterol Hepatol. 2016; 1: 196-206
        • Hill A.
        • Waters L.
        • Pozniak A.
        Are new antiretroviral treatments increasing the risks of clinical obesity?.
        J Virus Erad. 2019; 5: 41-43
      2. Molina JM, Tremblay C, Charreau I, et al. On-demand PrEP with TDF/FTC remains highly effective among MSM with infrequent sexual intercourse: a sub-study of the ANRS IPERGAY trial. Abstract 3629. Presented at the 9th Conference for the International AIDS Society, Paris, France; July 23-26, 2017. Available at: http://programme.ias2017.org/Abstract/Abstract/3629. Accessed January 12, 2020.

        • Saag M.S.
        • Benson C.A.
        • Gandhi R.T.
        • et al.
        Antiretroviral drugs for treatment and prevention of HIV infection in adults: 2018 recommendations of the International Antiviral Society–USA Panel.
        JAMA. 2018; 320: 379-396
        • World Health Organization
        WHO endorses event driven PrEP for gay men.
        (Available at:)
        • Siegler A.J.
        • Mouhanna F.
        • Giler R.M.
        • et al.
        The prevalence of pre-exposure prophylaxis use and the pre-exposure prophylaxis-to-need ratio in the fourth quarter of 2017, United States.
        Ann Epidemiol. 2018; 28: 841-849
        • Volk J.E.
        • Marcus J.L.
        • Phengrasamy T.
        • et al.
        No new HIV Infections with increasing use of HIV preexposure prophylaxis in a clinical practice setting.
        Clin Infect Dis. 2015; 61: 1601-1603
        • Anderson P.L.
        • Glidden D.V.
        • Liu A.
        • et al.
        Emtricitabine-tenofovir concentrations and pre-exposure prophylaxis efficacy in men who have sex with men.
        Sci Transl Med. 2012; 4: 151ra125
        • San Francisco Department of Public Health
        HIV epidemiology annual report 2018.
        (Available at:)
      3. Sullivan PS, Smith DK, Giler RM, et al. The impact of pre-exposure prophylaxis with FTC/TDF on HIV diagnoses, 2012-2016, United States. Abstract LBPEC036. Presented at 22nd International AIDS Conference, Amsterdam, the Netherlands; July 24-27, 2018.

      4. Smith DK, Van Handel M, Grey JA. By race/ethnicity, blacks have highest number needing PrEP in the United States. Abstract 86. Presented at Conference on Retroviruses and Opportunistic Infections, Boston, MA; March 4-7, 2018.

        • Calabrese S.K.
        • Magnus M.
        • Mayer K.H.
        • et al.
        Putting PrEP into practice: lessons learned from early-adopting U.S. providers’ firsthand experiences providing HIV pre-exposure prophylaxis and associated care.
        PLoS One. 2016; 11 (e0157324)
      5. Micromedix drug pricing.
        (Available at:)
        https://www.micromedexsolutions.com
        Date accessed: January 17, 2020
        • Gilead Sciences
        United States Securities and Exchange Commission. Washington, D.C. Form10-Q, page 35.
        (Available at:)
        • World Health Organization
        Global price reporting mechanism.
        (Available at:)
        • Berwick D.M.
        Disseminating innovations in health care.
        JAMA. 2003; 289: 1969-1975
        • Qato D.M.
        • Zenk S.
        • Wilder J.
        • Harrington R.
        • Gaskin D.
        • Alexander G.C.
        The availability of pharmacies in the United States: 2007–2015.
        PLoS One. 2017; 12 (e0183172)
        • Centers for Disease Control and Prevention
        Estimated HIV incidence and prevalence in the United States 2010–2016.
        (Available at:)
        • Centers for Disease Control and Prevention
        HIV prevention pill not reaching most Americans who could benefit-especially people of color.
        (Available at:)
        • National Alliance of State Pharmacy Associations
        Pharmacist prescribing: hormonal contraceptives.
        (Available at:)
        https://naspa.us/resource/contraceptives/
        Date accessed: January 18, 2020
        • American Pharmacists Association
        Pharmacists Provide Care: pharmacist scope of services factsheet.
        (Available at:)
        https://pharmacistsprovidecare.com/facts
        Date accessed: January 18, 2020
        • Collins B.
        • Bronson H.
        • Elamin F.
        • Yerkes L.
        • Martin E.
        The “no wrong door approach” to HIV testing: results from a statewide retail pharmacy-based HIV testing program in Virginia, 2014-2016.
        Public Health Rep. 2018; 133: 34S-42S
        • Gardiner D.
        Gavin Newsom signs bill to make anti HIV drug available without prescription.
        (Available at:)
        • Centers for Disease Control and Prevention
        Updated guidelines for antiretroviral postexposure prophylaxis after sexual, injection drug use, or other nonoccupational exposure to HIV–United States, 2016.
        (Available at:)
        https://www.cdc.gov/hiv/risk/pep/index.html
        Date accessed: January 18, 2020
        • Hoth A.
        • Shafer C.
        • Dillon D.
        • et al.
        Iowa TelePrEP: preliminary experience with a public health-partnered, telemedical PrEP delivery model in a rural state.
        Open Forum Infect Dis. 2018; 5: S397
      6. Keenan R, Lewis J, Sanchez D, et al. The next step in PrEP: evaluating outcomes of a pharmacist-run HIV pre-exposure prophylaxis (PrEP) clinic. Abstract 1293. Presented at ID Week Conference; San Francisco, CA: October 3-7, 2018.

        • Havens P.J.
        • Scarsi K.K.
        • Sayles H.
        • et al.
        Acceptability and feasability of a pharmacist-HIV pre-exposure prophylaxis (PrEP) program in the midwestern United States.
        Open Forum Infect Dis. 2019; 6 (Available at: https://doi.org/10.1093/ofid/ofz365. Accessed January 18, 2020.)ofz365
        • Dong J.B.
        • Grant M.R.
        • Lopez I.M.
        Response to: Acceptability and feasability of a pharmacist-led HIV pre-exposure prophylaxis (PrEP) program in the midwestern United States..
        Open Forum Infect Dis. 2019; 6ofz497https://doi.org/10.1093/ofid/ofz497
        • Tung E.L.
        • Thomas A.
        • Eichner A.
        • Shalit P.
        Implementation of a community pharmacy-based pre-exposure prophylaxis service: a novel model for pre-exposure prophylaxis care.
        Sex Health. 2018; 15: 556-561
        • Lopez M.I.
        • Cocohoba J.M.
        • Cohen S.E.
        • Trainor N.
        • Levy M.M.
        • Dong B.J.
        Implementation of pre-exposure prophylaxis at a community pharmacy through a collaborative practice agreement with San Francisco department of public health.
        J Am Pharm Assoc (2003). 2020; 60: 138-144
        • Patel A.R.
        • Breck A.B.
        • Law M.R.
        The impact of pharmacy-based immunization services on the likelihood of immunization in the United States.
        J Am Pharm Assoc (2003). 2018; 58: 505-514.e2
        • Lu S.
        • Rafie S.
        • Hamper J.
        • Strauss R.
        • Kroon L.
        Characterizing pharmacist-prescribed hormonal contraception services and users in California and Oregon pharmacies.
        Contraception. 2019; 99: 239-243
        • van Lint J.A.
        • Sorge L.A.
        • Sorensen T.D.
        Access to patients’ health records for drug therapy problem determination by pharmacists.
        J Am Pharm Assoc (2003). 2015; 55: 278-281
        • U.S. Food and Drug Administration
        CLIA–clinical laboratory improvement amendments–currently waived analytes.
        (Available at:)
        • Levy S.
        Flipping the script: the state of the pharmacy industry.
        (Available at:)
        • Bannow T.
        CVS to aggressively expand healthcare services in stores.
        (Available at:)
        • Walgreens Newsroom
        Walgreens and LabCorp to open at least 600 labcorp at Walgreens patient service centers.
        (Available at:)
        • Pharmacy Times
        2018 digest: community pharmacy 35% of retail pharmacy space.
        (Available at:)
        • Gopisetty D.
        • Kurian M.
        CVS announces same day home delivery of prescriptions.
        (Available at:)
        • Al-Muslim A.
        Walgreens launches next-day prescription home delivery with FedEx.
        (Available at:)
      7. Mikati T, Jamison K, Daskalakis DC. Immediate PrEP initiation at New York city health clinics. Abstract 962. Paper presented at 26th Conference on Retroviruses and Opportunistic Infections, Seattle, WA; March 4-7, 2019.

        • Okoro O.
        • Hillman L.
        HIV pre-exposure prophylaxis: exploring the potential for expanding the role of pharmacists in public health.
        J Am Pharm Assoc (2003). 2018; 58: 412-420.e3
        • Shaeer K.M.
        • Sherman E.M.
        • Shafiq S.
        • Hardigan P.
        Exploratory survey of Florida pharmacists’ experience, knowledge, and perception of HIV pre-exposure prophylaxis.
        J Am Pharm Assoc (2003). 2014; 54: 610-617
        • Gebhart F.
        On the road to provider status.
        (Available at:)
        • University of Washington
        SB5557 expands patient care access in Washington.
        (Available at:)
        • Balick R.
        Tennessee is second state to credential and reimburse pharmacists as providers.
        Pharmacy Today. 2017; 23: 50
        • Bonner L.
        Texas pharmacists now providers in private health plans.
        (Available at:)

      Biography

      Maria I. Lopez, PharmD, AAHIVP, President of Clinical Services, Mission Wellness Pharmacy, San Francisco, CA

      Biography

      Robert M. Grant, MD, MPH, Professor of Medicine, University of California, San Francisco, CA

      Biography

      Betty J. Dong, PharmD, FASHP, FAPHA, FCCP, Professor of Clinical Pharmacy and Family and Community Medicine, University of California, San Francisco, CA