In the JournalsPerspective

Pharmacist-led program a feasible strategy for PrEP uptake

Joshua P. Havens, PharmD, BCPS
Joshua P. Havens

In Omaha, Nebraska, a small pilot study demonstrated that a pharmacist-led pre-exposure prophylaxis, or PrEP, program is a feasible way to increase PrEP uptake.

Last year, research was published in Clinical Infectious Diseases that showed expanding the role of pharmacists in penicillin skin testing could expand access and improve antimicrobial stewardship efforts. More recently, a study revealed that a hepatitis C virus treatment model driven by pharmacist involvement yielded high rates of sustained virologic response.

“In most states, pharmacists are allowed to provide pharmaceutical care by entering into collaborative practice agreements with medical providers. Pharmacists are easily accessible at most community pharmacies and now are increasingly more present in the ambulatory clinic setting,” Joshua P. Havens, PharmD, BCPS, clinical pharmacist of the HIV program, pharmacy director of the Nebraska AIDS Drug Assistance Program and assistant clinical professor at the University of Nebraska Medical Center, told Infectious Disease News.

There are over 60,000 community pharmacies in the United States, the study reported. Expanding the role of the pharmacist and incorporating them in the PrEP care process “potentially offers an alternative setting to reach individuals at risk for HIV acquisition,” according to Haven and colleagues.

A photo of a pharmacist speaking with a customer 
A small pilot study demonstrated the feasibility of a pharmacist-led PrEP program.
Source: Adobe Stock

“In the clinic setting, the implementation of PrEP services for an ambulatory care pharmacist could be easily done,” Havens said. “Conversely, a pharmacist-led PrEP service from the community pharmacy setting could work but would pose challenges that would need to be abated in order to properly deliver PrEP care.”

Between January and June 2017, 60 patients were enrolled in the pharmacist-led PrEP (P-PrEP) program. Overall, participants completed a total of 139 visits with pharmacists from a university-based HIV clinic, a community pharmacy and two community-based clinics. The mean age of participants was 34 years, 91.7% were men, 83.3% were white, 88.3% identified as men who sex with men and 80% were commercially insured.

At 3 months, the participant retention rate was 73%. This declined to 58% at 6 months, 43% at 9 months and 28% at 12 months. No seroconversion among participants was observed.

Of the participants who completed the patient satisfaction questionnaire, 100% said they would recommend the P-PrEP program, and pharmacists reported feeling comfortable conducting point-of-care testing. Very rarely did pharmacists report feeling uncomfortable during PrEP visits or experiencing workflow disruption, according to the study.

“Through the right training and professional relationships with medical providers, pharmacists can help to close the PrEP provider gaps and re-reinforce the recent shifts by the Trump administration to end the HIV epidemic,” Havens said. – by Marley Ghizzone

Disclosures: Havens reports no relevant financial disclosures. Please see the study for all other authors’ relevant financial disclosures.

Joshua P. Havens, PharmD, BCPS
Joshua P. Havens

In Omaha, Nebraska, a small pilot study demonstrated that a pharmacist-led pre-exposure prophylaxis, or PrEP, program is a feasible way to increase PrEP uptake.

Last year, research was published in Clinical Infectious Diseases that showed expanding the role of pharmacists in penicillin skin testing could expand access and improve antimicrobial stewardship efforts. More recently, a study revealed that a hepatitis C virus treatment model driven by pharmacist involvement yielded high rates of sustained virologic response.

“In most states, pharmacists are allowed to provide pharmaceutical care by entering into collaborative practice agreements with medical providers. Pharmacists are easily accessible at most community pharmacies and now are increasingly more present in the ambulatory clinic setting,” Joshua P. Havens, PharmD, BCPS, clinical pharmacist of the HIV program, pharmacy director of the Nebraska AIDS Drug Assistance Program and assistant clinical professor at the University of Nebraska Medical Center, told Infectious Disease News.

There are over 60,000 community pharmacies in the United States, the study reported. Expanding the role of the pharmacist and incorporating them in the PrEP care process “potentially offers an alternative setting to reach individuals at risk for HIV acquisition,” according to Haven and colleagues.

A photo of a pharmacist speaking with a customer 
A small pilot study demonstrated the feasibility of a pharmacist-led PrEP program.
Source: Adobe Stock

“In the clinic setting, the implementation of PrEP services for an ambulatory care pharmacist could be easily done,” Havens said. “Conversely, a pharmacist-led PrEP service from the community pharmacy setting could work but would pose challenges that would need to be abated in order to properly deliver PrEP care.”

Between January and June 2017, 60 patients were enrolled in the pharmacist-led PrEP (P-PrEP) program. Overall, participants completed a total of 139 visits with pharmacists from a university-based HIV clinic, a community pharmacy and two community-based clinics. The mean age of participants was 34 years, 91.7% were men, 83.3% were white, 88.3% identified as men who sex with men and 80% were commercially insured.

At 3 months, the participant retention rate was 73%. This declined to 58% at 6 months, 43% at 9 months and 28% at 12 months. No seroconversion among participants was observed.

Of the participants who completed the patient satisfaction questionnaire, 100% said they would recommend the P-PrEP program, and pharmacists reported feeling comfortable conducting point-of-care testing. Very rarely did pharmacists report feeling uncomfortable during PrEP visits or experiencing workflow disruption, according to the study.

“Through the right training and professional relationships with medical providers, pharmacists can help to close the PrEP provider gaps and re-reinforce the recent shifts by the Trump administration to end the HIV epidemic,” Havens said. – by Marley Ghizzone

Disclosures: Havens reports no relevant financial disclosures. Please see the study for all other authors’ relevant financial disclosures.

    Perspective
    Monica Mahoney

    Monica Mahoney

    The United States has been tasked with reducing new HIV transmission by 90% by 2030. To do that, a multipronged approach must be taken to identify patients with unknown infections, achieve and maintain suppression with antiretrovirals and prevent acquisition of new infections. PrEP is a vital component in achieving the latter. 

    The CDC has outlined criteria for patients who are deemed at high risk of acquiring HIV and are ideal candidates for PrEP. Patients receive baseline screening, and eligible patients are prescribed daily emtricitabine/tenofovir disoproxil fumarate (FTC/TDF). PrEP efficacy is correlated with medication adherence, so education is paramount to success. A successful PrEP program involves repeat follow-up visits, counseling regarding STIs and confirmed ongoing HIV seronegativity. 

    Expanding PrEP is a key component to achieving the 2030 reduced transmission goal. However, an increase in HIV clinicians and access to PrEP programs is necessary, to truly realize the benefits. A recent report from the PEW Charitable Trusts highlights the desperate need of HIV doctors in the southern U.S. Young physicians are not choosing infectious diseases as specialties, and of those who do, even fewer choose HIV. Older physicians may be reluctant to train or treat patients with HIV owing to the social stigma attached to the disease. This has resulted in a dramatic shortage of HIV providers in the most vulnerable areas of the HIV epidemic. Undue hardships are therefore placed on willing patients, requiring hours of travel time, reliance on unreliable public transportation and necessitating loss of wages from taking time off work.

    Recently, data on creative ways to expand PrEP have been emerging. Havens and colleagues report their experience with a pilot pharmacist-lead PrEP program in university-based and community-based clinics. Pursuant to collaborative practice agreements (CPAs) between pharmacists and an overseeing physician, pharmacists were able to recruit 60 patients, perform baseline point-of-care testing, interpret results, prescribe FTC/TDF and perform follow-up visits. Although the study had a small sample size, the results were encouraging, with patient retention and satisfaction, pharmacist comfort and, most importantly, lack of seroconversion.               

    These results nicely complement those by Kamis and colleagues, where same-day PrEP was offered to patients at an STI clinic. After baseline screening, 100 patients were provided with free FTC/TDF that day and linked with a patient navigator for continued care and subsequent PrEP. Results demonstrated patient satisfaction and feasibility and safety of initiating same-day PrEP in STI clinics.

    Reading these studies, common themes emerge. First, we need to foster collaboration among physicians and other types of health care providers. Pharmacists, nurses, nurse practitioners, and physician assistants can help expand services in rural and underserved areas. All states need to pass laws allowing CPAs between physicians and nonphysicians to be able to provide these services. Second, point-of-care testing should be used to facilitate same-day PrEP and not delay administration. Uptake and satisfaction were increased if medication was not delayed. Third, funding must be provided to help offset the cost of FTC/TDF, whether this is through commercial insurance, government funding (Ryan White HIV/AIDS Program) or philanthropic funding. Recently, the cost of a 1-month supply of FTC/TDF has increased to more than $2,000 in the U.S. This is cost prohibitive to many who are deemed appropriate PrEP candidates. Lastly, the current studies were smaller scale pilots. Coordination and commitment must be ensured to mobilize these programs on larger scales.   

    We can achieve the 2030 goal, however, not without overhauling the current model of care.  An increase in the number of ID physicians would be ideal; however, this is not likely to occur rapidly. Therefore, clinicians must work together to expand the geographic outreach of PrEP programs. Thoughtful pharmacist-physician collaborations can be one approach to meeting this goal in underserved areas. 

    References:

    CDC. PrEP. https://www.cdc.gov/hiv/basics/prep.html.  Accessed August 22, 2019.

    Havens JP, et al. Open Forum Infect Dis. 2019;doi:10.1093/ofid/ofz365.

    HIV.gov. What is ‘Ending the HIV Epidemic: A Plan for America’? https://www.hiv.gov/federal-response/ending-the-hiv-epidemic/overview. Accessed August 22, 2019.

    Kamis KF, et al. Open Forum Infect Dis. 2019;doi:10.1093/ofid/ofz310.

    PEW. There aren’t enough doctors to treat HIV in the south.  https://www.pewtrusts.org/en/research-and-analysis/blogs/stateline/2019/08/05/there-arent-enough-doctors-to-treat-hiv-in-the-south. Accessed August 22, 2019.

    • Monica Mahoney, PharmD, BCPS-AQID
    • Clinical pharmacy specialist
      Beth Israel Deaconess Medical Center

    Disclosures: Mahoney reports no relevant financial disclosures.