Arizona Journal of Pharmacy O F F I C I A L P U B L I C A T I O N O F A R I Z O N A P H A R M A C Y A S S O C I A T I O N | F A L L 2 0 2 3 Put Some PrEP in Your Step Legislative Recap In This Edition: Kimberly Langley, PharmD, MBA, BCPS, FAzPA Happy American Pharmacists Month! AzPA President 2023-2024
        BoardofDirectors2023-2024
          OFFICERS
          PresidentKimberlyLangley
          President-ElectPro-TemporeJacobSchwarz
          ImmediatePastPresidentDawnGerber
          TreasurerRyanGries
          SecretaryBrandyDeChellis
          
    Director/CEOKellyFine
          DIRECTORSATLARGE
          CommunityBrianneSpaeth
          HealthSystemMaryManning
          TechnicianMelindaBrowning
          JosephPellerito
          JimmyStevens
          ReasolChino
          MistyBrannon
          DanielleGilliam
          LIASIONS
          UniversityofArizona
          StudentChapterDavidElias-Campa
          Dean'sDesignatedRepresentativeNancyAlvarez
          MidwesternUniversity
          StudentChapterShamsRehman
          Dean'sDesignatedRepresentativeMichaelDietrich
          CreightonUniversity
          StudentChapterHaleyDeMartinis
          Dean'sDesignatedRepresentativeJaneStein
          LegalCounsel
          RogerMorris
          AzPAStaff
          ChiefExecutiveOfficer
          KellyFine
          Education&ProfessionalDevelopment
          DawnGerber
          Events&StrategicPartnerships
          CindyEsquer
          Membership&VolunteerServices
          MarquesBottorf
          StrategicPrograms
          KristinCalabro
          AdministrativeServices
          MelinaEsquer
          Editor KellyFine
          CreativeCoordinator
          ElizabethNelson
          TheinteractivedigitalversionoftheArizonaJournalofPharmacyisavailableformembers onlyonlineinyourmemberportal
          (480)838-3385|admin@azpharmacy.org
          Editor'sNote:Anypersonalopinionsexpressedinthismagazinearenotnecessarilythose heldbytheArizonaPharmacyAssociation."ArizonaJournalofPharmacy"(ISSN1949-0941) ispublishedquarterlybytheArizonaPharmacyAssociationat:1845E.SouthernAvenue, Tempe,AZ85282-5831
          
    President’s Message 4 Contents COVER STORY
        pg. 4 AzPA News Welcome New Members 5 Editorial Happy American Pharmacists Month 6 Advocacy Legislative Update 29 Continuing Education Put Some PrEP in Your Step 13 Az-ASHP State Affiliate News 8 University & Alumni News 21 Arizona Board of Pharmacy Update 30 Preceptors Corner 10 Auditors Crack Down on Pharmacists that Bypass Plan Limits 27 AzPA License Bundles are Back 7 ASBP Sides with AzPA & Independent Pharmacy Coalition 32
        
              
              
            
            U P C O M I N G E V E N T S
          November 4 | Virtual
          November 14-16 | Virtual
          
    
    November 4 | Virtual
          April 20-21 | Glendale
          
    
    February 24-25 | Phoenix, AZ
          
    
    
    June 6-9 | Phoenix, AZ
          June 6 | Phoenix, AZ
          3
        Kimberly “Kim” Langley, PharmD, MBA, BCPS, FAzPA is the Chief Financial O cer for the DoD Federal Electronic Health Record Modernization o ce responsible for implementing a single, common federal electronic health record system for Department of Defense, Department of Veteran A airs, Department of Homeland Security, and the National Oceanic and Atmospheric Administration CDR Langley is a pharmacist in the U.S. Public Health Service (USPHS) Commissioned Corps and has been on continuous active duty since 2009 She has completed previous USPHS assignments at multiple duty stations across New Mexico and Arizona with Indian Health Service During this time, CDR Langley served in several diverse leadership positions including Pharmacy Manager, PGY-1 Residency Program Director, Cardiovascular Clinic Director, and IHS Agency- Representative to the Million Hearts Initiative. In 2015, CDR Langley served as the Chief Pharmacy O cer for her team in Liberia as a part of the Ebola crisis response in West Africa
          CDR Langley holds a Bachelor of Science in Medical Technology from Georgia Southern University; a Doctor of Pharmacy degree from Medical University of South Carolina; a Master of Business Administration from The Citadel; and completed a Certi cate in Business Process Management from Villanova University She is also boardcerti ed in Pharmacotherapy and served on multiple technical expert panels for Pharmacy Quality Alliance for the development of cardiovascular and diabetes quality measures
          
    CDR Langley is actively engaged in AzPA activities including serving on the Board of Directors as President-Elect, Director-at-Large, APhA House of Delegates Representative, member on several committees, faculty for 2 certi cate programs, abstract peer reviewer, and conference speaker Her leadership experience extends to various roles on multiple USPHS committees, workgroups, and mentoring programs.
          Dear AzPA Members,
          As the President of Arizona Pharmacy Association, I am deeply honored and grateful for this opportunity to serve in this esteemed position! I have had the opportunity to re ect on changes in my professional life with stepping into this new leadership role as well as my personal life with becoming the parent of a  rst-year college student this fall What has stood out most during my thoughts on change is that change is inevitable However, with support and planning, these changes can be boldly faced together. Since taking o ce in June at the Annual Convention, the Board of Directors has been working hard to develop and execute the 3-year strategic plan to lead change towards our mission of unifying, amplifying, and empowering the voice of pharmacy in Arizona. I am so proud of our AzPA leaders in their commitment to the profession and most importantly, our members!
          While there is still so much more to be done, AzPA has had some positive changes to celebrate Our advocacy e orts have resulted in Arizona pharmacists joining the growing number of pharmacists across the nation that are able to prescribe hormonal contraceptives. This has been an e ort that has taken collaboration, persistence, and determination. We are grateful to the many advocates, champions, and partners that have helped us be successful in this area. We have also seen a big step forward on payment of pharmacy services. AzPA has been working with BlueCross/Blue Shield of Arizona for the past year and we are pleased to announce that Arizona pharmacists can be credentialed as providers for reimbursement of pharmacy services under this commercial plan More information will be forthcoming about this collaboration, but we are excited to leverage these  rst steps towards provider status and payment for services in our state
          Despite these successes, we can’t stop there. Change is a certainty in the evolving landscape of pharmacy. In the words of Mahatma Gandhi, “you must be the change you want to see in the world”. Let us as members of AzPA be that change, together! The journey ahead may be challenging as we navigate and adapt to improve wellbeing and workplace conditions, promote sustainability in pharmacy business practice, address wage gaps and workplace shortages, increase medication access, and implement new technologies in pharmacy practice, but I am encouraged by the potential for us to lead that change together in Arizona Let’s blaze a trail to our future!
          PRESIDENT'S
        4
        Kimberly “Kim” Langley, PharmD, MBA, BCPS, FAzPA 2023-2024 AzPA President
          EDITORIAL
        MESSAGE
        
              
              
            
            WELCOME NEW MEMBERS!
          2nd Year Practitioner
          Mohanad Znbaqa
          Pharmacist
          Kathleen Brakebush
          Olivia Brandner
          Jacqueline Campbell
          Chandima Deegala
          Nate Evans
          Derek Fomba
          Shannon Gri th
          Dominick Grosso
          Joseph Haimann
          Jared Hatchard
          Ashley Krumenacker
          Maranda Lofton
          Amy Nguyen
          Tran Nguyen
          Elisabeth Palmer
          James Parrish
          Samira Samarbakhsh
          Laura Michelle Vaughn
          Premium Pharmacist
          Thuy Nguyen
          Gregory Nipper
          Kate Van Hassel
          Retired
          Christopher Hogan
          Sherif McCormick
          Eileen Webster
          Technician
          Geo rey Boadu
          Charles Case
          Shauna Geis
          Vanessa Gervais
          Myra James
          Ashley Merrick
          Sharon Miller
          Kadean Perrone
          Annette Wright-Smith
          Resident
          Je rey Bezard
          Kathryn Bohannan
          Monique Busacay
          Lauren Campisi
          Jonathan Choe
          Lillianne Do
          Edith Ford
          Hannah Henderson
          Alexandra Leath
          Alexis Marsden
          Amy Moet
          Rima Patel
          Christine Perry
          Alexis Smith
          Scott Volker
          Fredi Young
          Student Pharmacist
          Lester Lee Acoba
          Hasan Alaani
          Ravaida Ali
          Lien Alimam
          Oday Aliadir
          Randee Alkhayyat
          Vanessa Arbolida
          Gilberto Arroyo
          Jessica Barnabei
          Cecilia Bercovich
          Jennifer Bloxham
          Andrew Bobbitt
          Faris Bodagh
          Sarah Brewer
          John Briggs
          Brooke Chavez
          Gabrielle Ciadella
          Richard Conway
          Kara D'Angina
          Haylee Daniel
          Jacqueline David
          Haley DeMartinis
          Etornam Doe
          Hazel Eastlack
          Mackenna Elliott
          Sherif Elsayed
          Tatyana Eydelnant
          Logan Farrington
          Carla Fernandez
          Maxwell Finkler
          Haily Francis
          Lourdes George
          Aaron Gilmore
          Monique Guevara
          Gianna Haddad
          Elizabeth Marcia Halm
          Sabrina Hernandez
          Kristi Howard
          Eric Jelen
          Grace Khan
          Nicole Leiphon
          Riley Loehr
          Viridianna Lopez
          Marie Lopez-Carreon
          John MacDonald
          Caroline Manweiler
          Angel Martinez
          Brenda Mata
          Mekayla Mehrara
          Evelyn Montes
          Sandra Moreno
          Kyle Murphy
          Anthony Musil
          Kathy Ngo
          ThyThy Nguyen
          Adassa Nissan
          Shahd Omer
          Jose Oregel
          Batuhan Ozdiker
          Nicole Parnett
          Jahnvi Patel
          Rand Paul
          Sandra Paul
          Rozabel Peterson
          Lisa Regalado
          Trevor Riley
          Mohamed Rizk
          Jerdawn Robinson
          Ryan Rodrigues
          Adrian Rodriguez
          Mark Rothpletz
          Maria Sarwar
          Madelyn Sawyer
          Tyler Sedig
          Praise Setodji
          Ryan Shumway
          Rajdeep Sidhu
          Melissa Starks
          Amy Tanase
          Cody Tipp
          Behnoush Tohidnia
          Sahar Toluee Achacheluee
          Esmeralda Torres
          Perla Torres
          Katherine Tran
          Nick Tromba
          Kevin Tsinigine
          Crystal Vo
          Traci Wynder
          Ramez Youssef
          Martha Zeng
          AZPA NEWS
        5
        HISTORY OF AMERICAN PHARMACISTS MONTH
          It all started in October 1925 For one week, radio stations across the country broadcasted special programming to highlight the profession of pharmacy.
          In 2004, after celebrating National harmacy Week for nearly 8 decades, APhA ecognized October as American harmacist Month and has so ever since.
          
    IMPORTANT DATES
          •
          October 1-31: American Pharmacists
          
    Month
          • October 15-21: National Pharmacy
          •
          
              
              
            
            HAPPY AMERICAN PHARMACISTS MONTH!
          
    
    Happy American Pharmacists Month from AzPA -- a time to recognize pharmacists’ contributions to health care and all they can do for their communities!
          
    Nominate Your Pharmacy Department! Calling All Pharmacy Professionals! Nominate your pharmacy or department today for an appreciation treat delivery by AzPA leaders during Pharmacy Month this October Let's celebrate your hard work and dedication! #AzPA #PharmacyMonth
          Nominate Your Pharmacy!
          October 12: Woman Pharmacist Day
          Week
          • October 17: Pharmacy Technician Day
          
    Thursday, October 12
          October 15 - October 21
          Tuesday, October 17
          PHARMACISTS MONTH
        EDITORIAL
        6
        CELEBRATE WITH US! RSVP Here!
        
              
              
            
            AZPA LICENSE RENEWAL BUNDLES ARE BACK!
          
    Still need CE for your renewal? We've got you covered!
          These License Renewal Bundles are a cost-e ective way to get CE for your license renewal quickly -- see the topics below and click for more information!
          TOPICS
          Law = 2 25 hours
          Immunization = 2 hours
          Opioids = 3 hours
          Patient Safety = 1 hour
          Tobacco Cessation = 2 hours
          Note: These CPE programs have been previously o ered at AzPA Conferences -If you have already claimed credit for these CPE sessions already you will NOT be able to claim credit again
          
    FEES
          AzPA Member Technician - $79
          Non-Member Technician - $99
          
    AzPA Member Premium Pharmacist - $119
          AzPA Member Pharmacist - $129
          Non-Member Pharmacist - $199
          EDITORIAL PHARMACISTS MONTH
        Have Questions about Renewal Requirements? SkiptotheArizonaBoardofPharmacy Updatetolearnmore! GotoPage30 Learn More! 7
        
              
              
            
            AzPA HEALTH SYSTEM SPECIAL INTEREST GROUP (AZ-ASHP)
          
    
    I’d like to start o  with a quick thank you to Chris Edwards who led the AzPA Health System Special Interest Group (SIG) for the last two years! He has now turned over the reins to me and I am excited to work with you ALL With fall just around the corner and some cooler temps on the way, I hope you will be motivated to become a member of the Health System SIG. Our monthly meetings cover issues relevant to health system pharmacists in Arizona Recent topics have included barriers to dispensing naloxone from hospital emergency departments, infusion site of care strategies, drug shortages, as well as ASHP legislative updates. The more perspectives we have on this group, the more we can make sure AzPA is serving the needs of its health system members. If you are interested in getting involved, please sign up using the link below https://azpharmacy org/health-system-sig/
          Additionally, even though spring seems to be aways o , we will begin planning for the Spring Clinical Meeting very soon This meeting will be held on February 24 & 25, so mark your calendars now! AzPA’s Spring Clinical Conference serves as our ASHP state a liate chapter’s annual meeting. At our monthly SIG meetings, we want to hear from you regarding topics that you  nd interesting and would like to learn more about
          Respectfully,
          
    Mary Manning, PharmD, MBA, BCPS AzPABoardofDirectors-HealthSystem
          More Here AZ-ASHP AFFILIATE NEWS 8
        Mary Manning, PharmD, MBA, BCPS AzPA Board of Directors-Health System
          Learn
        
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            Tailoring Rotation Experiences for Unique
          Learner Needs
          
    AUTHORS/CONTRIBUTORS
          LauraHanson,PharmD,BCGP,QualityAssuranceSiteVisitor,Department ofPharmacyPractice,MidwesternUniversityCollegeofPharmacy
          SuzanneLarson,PharmD,DirectorofExperientialEducation,Departmentof PharmacyPractice,MidwesternUniversityCollegeofPharmacy
          JanetCooley,PharmD,BCACPDirectorofExperientialEducation,Departmentof PharmacyPracticeandScience,R.KenCoitCollegeofPharmacy,UniversityofArizona
          DISCLOSURE
          Theauthor(s)declarenorealorpotentialconflictsorfinancialinterestinanyproduct orservicementionedinthemanuscript,includinggrants,equipment,medications, employment,gifts,andhonorarium.
          FUNDING
          Nofundingwasprovided.
          ACKNOWLEDGEMENT
          Theauthorgratefullyacknowledgesallpharmacypracticepreceptorsdedicatedto providinghighqualitylearningexperiences.
          EDITORIAL PRECEPTOR CORNER 10
        
              
              
            
            CONT. PRECEPTOR CORNER
          Experiential rotations o er learners many opportunities for professional and personal development Each learner is unique with varied interests and backgrounds and may bene t from speci c activities and experiences to gain full bene t from a given rotation The purpose of this article is to assist preceptors in identifying opportunities to tailor rotation opportunities and activities for a learner’s speci c needs In this article the term “learner” will be used to describe both resident and student pharmacists, and the principles discussed apply to both levels of learners
          At  rst glance, some may believe that tailoring rotations is related to learning styles (e g auditory vs visual learners) and the concept of “meshing” or the aligning of one’s teaching methods to the learner’s preferred learning style The concept of meshing may be of bene t, but literature is not yet conclusive about recommendations for employing meshing as an e ective teaching strategy. The practice of tailoring, however, goes beyond the concept of meshing to incorporate learner professional and academic history, interest areas, professional experience, and future goals.
          The concept of tailoring rotations and is encouraged by the Accreditation Committee for Pharmacy Education (ACPE) and American Society of Health System Pharmacists (ASHP). Per ACPE, preceptors are encouraged to assess “students’ prior knowledge and experience relative to the rotation’s objectives”. This allows the preceptor to tailor the rotation to maximize the student’s educational experience and ensure appropriate interaction with patients, their caregivers, and other health professionals, as applicable. Per ASHP, residency programs must work with residents to create a personalized development plan including “documented re ection by the resident on career goals, practice interests, and well-being and resilience”. Based on this individualized re ection, residency programs are expected to make “…[a]djustments …based on resident’s strengths and opportunities for improvement relative to the programs competency areas, practice interests, and career goals”.
          How can I tailor a rotation to my individual learner’s needs? Get to know your learner
          The  rst step in tailoring rotations e ectively is to gain a deep knowledge of individual learners’ interests, background, past experiences, and goals, as well as learning what motivates and inspires the learner This information can be gathered in a variety of ways, including conversations, a learner introduction form, reviewing the learner’s CV, or scheduling an informal lunch
          meeting. This knowledge forms a basis for subsequent customization planning. Having a standardized process in place to get to know learners early can ensure this important step is not missed or delayed
          Identify modi cations of core competencies
          Once the individual characteristics and needs of the learner are clear, preceptors can then re ect on how available opportunities at the site can be leveraged to best meet these needs and promote optimal learning and development A balance between core rotation requirements with an element of customization is encouraged so that all essential competencies, experiences, and activities are completed as required There are often many ways to approach completion of these requirements
          If a learner has a strong interest in a particular disease state or patient population, preceptors can select patients from these subsets for students to follow (e g assigning patients receiving antibiotics for a learner interested in infectious disease)
          Topic discussions and drug information projects can focus on areas of learner interest (e g a Medication Use Evaluation focused on cost for learners interested in pharmacoeconomics or a project focused on patient education pearls for learners interested in ambulatory care)
          One commonly encountered challenge is a learner in the hospital/institutional setting who is intent on working in the community setting and has most of their professional experience in this space Initially, this learner may not perceive value in a standard acute care rotation; however, the preceptor can tailor the rotation experiences and activities to demonstrate the continuum of care and the pharmacist’s essential role in medication reconciliation and communication among care settings The core competencies of the acute care rotation can be met while still allowing the learner to  nd personal ful llment and motivation through rotation tailoring. While this example is speci c to one practice setting, the concept can be applied to almost any rotation setting.
          Identify supplementary learning opportunities
          Learners often engage in activities and experiences to supplement core rotation requirements. This can include committee participation, advocacy activities such as Pharmacy Day at the Capitol, and professional development activities such as association meetings and board/licensing exam preparation. There are many ways in which these supplementary activities can be targeted to address student interests and needs. Some
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            CONT.
          
              
              
            
            PRECEPTOR CORNER
          examples can include providing opportunities to shadow other healthcare professionals in practice areas of interest to the learner, facilitating connections and networking in the learner’s area of interest, and connecting learners with supplementary materials such as continuing education modules or journal articles relating to pertinent topics
          Support your learner’s professional development needs Mentoring through direct discussion of the preceptor’s academic and career path and lessons learned is also invaluable to learners Practical logistical advice customized to the learner’s immediate career goals can consist of curriculum vitae/resume review, practice interview questions speci c to desired practice setting, and facilitating introductions to practitioners currently working in the space Additional discussion about assisting learners with professional development is found in a previous issue of the Arizona Journal of Pharmacy
          There are many ways to approach rotation tailoring and speci c approaches will vary widely depending on unique characteristics of preceptors, sites, and learners. A deep understanding of your learners’ motivations, goals, and background as well as opportunities within your practice site serves as the cornerstone of the process. Once this is achieved, modi cations within core rotation requirements that maintain the integrity of the requirements may be
          implemented The area with the most potential for customization is supplemental activities where creative approaches with learner input can lead to unique and highly bene cial opportunities In addition to addressing essential requirements from accrediting bodies, practicing rotation customization allows for re ection and self-awareness on the part of learners
          Preceptors and sites also bene t from the increased ful llment and satisfaction that comes from getting to know their learners and being part of their journey
          
    REFERENCES
          1 Romanelli F, Bird E, Ryan M (2009) Learning styles: a review of theory, application, and best practices. AmericanJournalofPharmaceuticalEducation ;73(1):9
          2 Accreditation Council for Pharmacy Education (ACPE) Accreditation Standards and Key Elements for the Professional Program in Pharmacy Leading to The Doctor of Pharmacy Degree (“Standards 2016”) https://www acpe-accredit org/pdf/Standards2016FINAL pdf Accessed Sept 11 2023
          3 American Society of Health System Pharmacists (ASHP) ASHP Accreditation Standard For Postgraduate Pharmacy Residency Programs https://www ashp org/-/media/assets/professionaldevelopment/residencies/docs/examples/ASHP-Accreditation-Standard-forPostgraduate-Residency-Programs-e ective-July-2023 pdf Accessed Sept 11 2023.
          4. Larson S, Cooley J, Gri n BL. Preceptor pearl: Your students want more professional development. Arizona Journal of Pharmacy. 2022 (Fall edition) 810 https://thinkgraphtech com/digital media/Arizona Pharm/Fall2022/ Accessed Sept 11 2023
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            Put Some PrEP in Your Step
          AUTHORS/CONTRIBUTORS
          ConnieLiang,PharmD,UniversityofMarylandSchoolofPharmacy
          NehaPandit,PharmD,BCPS,AAHIVP,UniversityofMarylandBaltimoreSchoolofPharmacy
          FUNDING - Thisresearchwasnotfunded
          DISCLOSURES - Theauthorshavenorelevantfinancialrelationshiptodisclose
          CONTINUING EDUCATION INFORMATION
          Target Audience: Pharmacists, Pharmacy Technicians
          Activity Type: Knowledge
          Pharmacist Learning Objectives:
          1 Compare the different Human Immunodeficiency Virus (HIV) preexposure prophylaxis (PrEP) medications.
          2 Identify individuals who are good candidates for HIV PrEP initiation.
          3 Provide counseling for individuals who are starting or continuing HIV PrEP
          4 Identify the role of pharmacists in HIV PrEP initiation.
          Pharmacy Technician Learning Objectives:
          1 Identify the HIV PrEP medications that are currently available
          
    2 Identify individuals who are good candidates for PrEP initiation.
          Note: The continuing education article was originally published in the Maryland Pharmacists Association's MarylandPharmacist'sSpring 2023 issue
          CONTINUING
        13
        Background
          In the early 1980s, the  rst cases of acquired immunode ciency syndrome (AIDS) surfaced in the United States and quickly marked the start of the AIDS epidemic with cases surging to 100,000 within seven years Shortly after, the  rst antiretroviral (ARV) medication was approved, and the subsequent use of highly active ARV led to a signi cant decline in AIDS-related deaths As clinical trials were being conducted on other ARVs for HIV treatment, studies were being done on the use of certain ARVs for prevention of HIV infection. Around 2010, the results of the iPrEx study and the TDF2 study showed that emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) greatly reduced the risk of acquiring human immunode ciency virus (HIV) for men who have sex with men (MSM) and individuals who have heterosexual sex
          This led to the 2012 FDA approval of FTC/TDF (Truvada®) for pre-exposure prophylaxis (PrEP) in individuals who are at high risk for HIV transmission. Currently, there are three forms of PrEP that are available in the United States including FTC/TDF and FTC/tenofovir alafenamide (TAF) (Descovy®) which are oral medications and cabotegravir (CAB) (Apretude®) which is a long-acting injectable medication
          Evidence Supporting the Use of HIV PrEP
          FTC/TDF and FTC/TAF combinations di er based on their tenofovir component. All three medications, TDF, TAF, and FTC are nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) and work by inhibiting viral replication through inhibition of the reverse transcriptase enzyme.
          See Table 1 for the results of the PrEP trials
          The Preexposure Prophylaxis Initiative (iPrEx) trial was a randomized, controlled trial that compared daily administration of oral FTC/TDF to placebo for PrEP in HIVnegative MSM or transgender women who have sex with men. The study found the FTC/TDF group had lower incidence of HIV acquisition compared to placebo. They also assessed adherence by monitoring pill counts. Of those that were found to be less than 50% adherent, FTC/TDF plasma drug concentrations were not detected in 86% and 100% of participants who were HIV-positive and HIV-negative, respectfully These results emphasize the importance of adherence in the e ectiveness of oral PrEP. The Partners Preexposure Prophylaxis study was a randomized, double-blind trial comparing oral TDF and FTC/TDF for PrEP in East African heterosexual men and women and found that both TDF and FTC/TDF resulted in a signi cant lower risk of HIV-1 infection
          Following the approval of FTC/TDF, the next oral PrEP medication that was approved by the FDA was FTC/TAF TAF is a prodrug of TDF and has been shown to achieve a
          higher intracellular concentration of the active drug compared to TDF. Based on these pharmacokinetic  ndings, TAF 25 mg once daily is bioequivalent to TDF 300 mg once daily The DISCOVER trial was a randomized, double-blinded, noninferiority trial to assess the safety and e cacy of FTC/TDF compared to FTC/TAF in MSM and transgender women who have sex with men FTC/TAF was found to be noninferior to FTC/TDF in preventing HIV-1 infection. Both drugs were well tolerated with similar adverse e ects. However, the FTC/TAF was found to have less bone mineral density loss and less renal function decline compared to FTC/TDF. Since the population included in this study only included MSM and transgender women who have sex with men, it remains unclear if the results of this trial can be extrapolated to other populations including heterosexual individuals
          Although once daily dosing is most commonly seen for FTC/TDF, a non-daily “on-demand” or “2-1-1” regimen has been studied in clinical trials which consists of taking two pills 2 to 24 hours before sex, then 1 pill 24 hours and 48 hours after the two-pill dose. This has not been FDAapproved and the purpose of this dosing schema was to provide an alternative for MSM who have infrequent sex and may not require daily doses of FTC/TDF The trials on non-daily dosing of PrEP have con icting results but is an available option based on the studies that demonstrated e cacy.
          CAB is the only long-acting injectable HIV PrEP which was FDA approved in 2021. It is a second-generation integrase strand transfer inhibitor which works by inhibition of the integrase enzyme preventing viral DNA integration into the human host cell The approval of this medication was based on two landmark trials, HPTN 083 and HPTN 084 The HPTN 083 study was a randomized, double-blinded trial to assess the safety and e cacy of long-acting cabotegravir injections (CAB-LA) in comparison to oral FTC/TDF in cisgender MSM and transgender women who have sex with men. Participants in the CAB-LA group received oral lead-in therapy with cabotegravir 30 mg for 5 weeks followed by CAB-LA 600 mg intramuscular injection on week 5, week 9, and every 8 weeks thereafter CAB-LA was found to be superior to daily oral FTC/TDF for HIV prevention There were no marked di erences in the frequency of grade two or higher adverse events between the groups including decreased creatinine clearance, increased creatine kinase, and nasopharyngitis. One signi cant di erence between the groups is that more participants in the CAB-LA group experienced injection site reactions (ISR), 81 4%, compared to the participants in the FTC/TDF group who received placebo injections, 31 3% However, only 2 4% of the participants in the CAB-LA
          continued on next page
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        CONT. CONTINUING EDUCATION
        5 6 7, 8 9 14
        group discontinued the injection due to the ISRs. The HPTN 084 trial was a randomized, double-blind superiority trial to evaluate the safety and e cacy of CAB-LA in comparison to oral FTC/TDF to prevent HIV in cisgender women and found that CAB-LA was superior to FTC/TDF for HIV prevention in women The most notable di erence in adverse e ects was ISRs in 38% of participants in CABLA group compared to 10 8% in the FTC/TDF group However, none of the participants discontinued the study due to the ISRs. This study showed that CAB-LA was e ective and safe for HIV prevention in women. These two trials showed that CAB-LA was e ective and safe for the prevention of HIV-1 infection in cisgender MSM, transgender women who have sex with men, and cisgender women
          The HIV PrEP Guideline recommends the assessment and initiation of HIV PrEP in patients who inject drugs (PWID) based on limited studies that show bene ts of HIV PrEP in PWID and that this population may also engage in high risk sexual behavior, consistent with the populations included in the studies discussed.
          Eligibility
          Adults and adolescents who weigh at least 35 kg are candidates for HIV PrEP if they are sexually active or inject drugs High risk individuals including those who had anal or vaginal sex in the past 6 months and either had a bacterial sexually transmitted infection (STI) in the past month, had inconsistent or no use of condoms, and/or have a sexual partner who is HIV-positive or has unknown HIV status may require more counseling. Individuals who have any of these risk factors should be o ered HIV PrEP. Individuals who do not have these risk factors may still be initiated on HIV PrEP after shared decision-making with a health care professional and weighing the risk versus bene ts
          Oral HIV PrEP
          FTC/TDF and FTC/TAF are supplied as a combination tablet and are indicated for patients who weigh at least 35 kg and are at-risk for sexually acquired HIV. Manufacturer labeling for FTC/TAF speci cally excludes patients who are at risk from receptive vaginal sex as this population was not evaluated in the clinical trials. For HIV PrEP, both FTC/TDF 200/300 mg and FTC/TAF 200/25 mg are given once daily by mouth without regards to food
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        CONT. CONTINUING
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        EDUCATION
        12
        Study Drug/Dosing Population Sample Size Median Follow up Time Period Outcomes iPrEx study3 Placebo FTC/TDF 200/300 mg MSM Transgender women who have sex with men 2499 participants 1 2 years Hazard ratio 0.56 (95% CI, 0.37 to 0.85) The PrEP study5 Placebo TDF 300 mg FTC/TDF 200/300 mg East African heterosexual men and women 4747 HIVserodiscordant couples 23 months Lower risk of HIV infection: TDF: 67% (95% CI, 44 to 81) FTC/TDF: 75% (95% CI, 55 to 87) DISCOVER8 FTC/TAF 200/25 mg FTC/TDF 200/300 mg MSM Transgender women who have sex with men 5387 participants 86 weeks Incidence rate ratio 0 47 (95% CI, 0.19 to 1.15) between FTC/TAF and FTC/TDF HPTN 08310 CAB-LA 600 mg IM FTC/TDF 200/300 mg MSM Transgender women who have sex with men 4566 participants 1.4 years Incident of HIV infection: CAB-LA: 0 41% FTC/TDF: 1.22% Hazard ratio of 0 34 (95% CI, 0 18 – 0 62) HPTN 08411 CAB-LA 600 mg IM FTC/TDF 200/300 mg Women who have vaginal intercourse 3224 participants 1.24 years Incident of HIV infection: CAB-LA: 0 20% FTC/TDF: 1.85% Hazard ratio of 0 12 (95% CI, 0 05 – 0 31)
        15
        Table 1. PrEP Studies
          
              
              
            
            CONT.
          
              
              
            
            CONTINUING EDUCATION
          For both medications, it is imperative to con rm that patients are HIV-negative with an HIV antigen/antibody (Ag/Ab) test and with no symptoms of acute HIV infection within one week of the  rst PrEP prescription Subsequently, patients must provide con rmatory HIV-negative tests (HIV Ag/Ab, HIV RNA) at least every three months or every time the patient tests positive for an STI while taking this medication because of the potential risk of resistance in patients who have undetected HIV infection Those who are found to be HIV-positive should be transitioned to a full HIV treatment regimen because FTC/TDF and FTC/TAF alone are inadequate for patients living with HIV Prior to starting oral HIV PrEP, patients should be tested and assessed for hepatitis B infection (HBV) as both medications have HBV activity and may cause exacerbation if discontinued abruptly.
          scheduled injection date which allows for a 14-day window to receive the dose. An HIV Ag/Ab test along with an HIV-1 RNA assay should be done at every scheduled injection appointment to con rm the patient is HIV-negative and does not have acute HIV Since CAB-LA is long-acting, when discontinuing the injection, the drug levels in the body gradually decline which increases the risk for developing resistance if patient acquires an HIV infection during this time
          Prior to and during treatment with both medications, renal function should be monitored, and adjustments made based on the ARVs. Use is not recommended in patients with an estimated creatine clearance (CrCl) of less than 30 mL/min for FTC/TAF and 60 mL/min for FTC/TDF For patients who are over 50 years old or have a CrCl that is less than 90 mL/min at HIV PrEP initiation, the renal function should be evaluated every six months. For all other patients on HIV PrEP, the renal function should be evaluated at least once a year Patients should be counseled on adherence and methods of protection to reduce the risk of transmission of other STIs (i e , condoms) Guidelines on further evaluation of STI screening and laboratory assessments while on PrEP are clearly noted in the HIV PrEP guideline
          Injectable HIV PrEP
          13, 14 12
          Since adherence is crucial for e cacy and prevention of resistance, it is important to ensure patients are ideal candidates CAB-LA use Some adverse e ects that can occur include ISRs, diarrhea, headache, fatigue, nausea, and abdominal pain See Table 2 for HIV PrEP dosing and toxicity. Since ISRs are the most common adverse reaction for patients using CAB-LA, it’s important to understand how to manage these reactions Patients may use over the counter pain medications either before or after the injection as needed for pain associated with the injection To alleviate the pain, warm compress can be applied to the injection site for 15 to 20 minutes after the injection.
          Pharmacy-Initiated PrEP
          CAB-LA is supplied as a 600 mg/3 mL suspension that is administered through gluteal intramuscular injection by a healthcare personnel It is only indicated in adults and adolescents who are at risk for HIV and weigh at least 35 kg Similar to oral PrEP initiation, individuals must be screened for HIV infection and must have a negative HIV Ag/Ab test within 1 week prior to initiation because starting CAB-LA as an HIV-positive patient can breed resistance. Prior to starting the CAB-LA injections, patients have an option to either start with oral lead-in with oral cabotegravir 30 mg dailyfor at least 28 days or start directly with the injections. The purpose of oral lead-in (OLI) therapy is to assess tolerability of CAB-LA prior to starting the long-acting injections. The elimination half-life of cabotegravir injection is 5 6 to 11 5 weeks which is much longer than that of oral cabotegravir (41 hours) If patients opt for OLI, the injection should be administered either on the last day or within three days of the last oral lead-in dose. Oral cabotegravir is not available in pharmacies in the United States and can be attained through TheraCom Pharmacy with no cost to the patients CAB-LA injections are given 4 weeks apart for the  rst two injections followed by injections every 8 weeks thereafter Patients may receive their injection one week prior or one week after their
          15, 16
          There are regions in the United States and globally where individuals face multiple barriers to adequate PrEP including  nancial di culties, lack of health literacy, costs of medications, lack of access to medical services and healthcare providers To address these barriers, pharmacist-initiated PrEP was introduced. Across the country, many pharmacists are initiating and managing patients on PrEP through collaborative practice agreements (CPAs) to improve access Factors to consider when navigating pharmacist-initiated PrEP include laws that clearly state the PrEP-related services pharmacists can provide that insurances should cover, providing additional trainings for pharmacists on PrEP, and deciding on the duration of time pharmacists can prescribe PrEP for a patient before referring them to a provider In 2021, a bill was introduced in Maryland that would allow pharmacists to dispense up to a 60-day supply of PrEP if a patient has proof of their negative HIV status and would be able to order con rmatory tests for patients Although the bill was not passed similar bills may be introduced in future legislative sessions. Maryland pharmacists currently cannot initiate HIV PrEP in the community pharmacy, but pharmacists practicing in this setting are often reviewing and dispensing HIV PrEP medications It is important for pharmacists to be prepared to answer questions and counsel patients on dosing, side e ects, and the importance of adherence. Community pharmacists are also able to identify patients who are eligible for HIV PrEP, provide education, and refer to appropriate healthcare providers for further assessment and initiation of therapy
          12 15 12 17
        continued on next page
        12 12
        16
        Counseling Points
          A multifaceted approach should be taken when deciding on which HIV PrEP to initiate for a patient. A thorough medication reconciliation should be completed to identify any drug interactions (See Table 3 for HIV PrEP Drug Interactions). Another factor to consider includes cost. See Table 4 for costs of the HIV PrEP medications Since FTC/TDF is the only product that has a generic formulation available, some insurances may prefer the generic product over brand products. It is also important to consider what population the patient most identi es with For example, if a heterosexual female who has receptive vaginal sex is looking for PrEP, FTC/TAF should not be recommended as it was not studied in this population See Table 5 for HIV PrEP coverage resources Another variable that may impact the choice of PrEP formulation is adherence. Oral PrEP’s e cacy is dependent on a patient’s ability to take their medication daily If they are nonadherent and are amenable to staying adherent to clinic visits, CAB may be a good alternative given its long-acting pharmacokinetics and once every 8week dosing frequency Taking into consideration patientspeci c factors is also crucial For example, depending on
          the patient’s CrCl, the appropriate PrEP options can change as someone who has a CrCl that is less than 60 mL/min would not be able to use FTC/TDF. Similarly, if a patient already has declining bone mineral density, then starting them on FTC/TDF may exacerbate this e ect and FTC/TAF would be a safer alternative.
          Conclusion
          In conclusion, there are currently three medications that are FDA-approved for PrEP on the market including FTC/TDF, FTC/TAF, and CAB, all of which have shown to be e cacious with good tolerability. The decision on which agent to start for PrEP is dependent on patient-speci c factors including medical conditions, cost, and adherence This also involves shared decision-making regarding the risks and bene ts of preventative treatment. Currently, there are numerous ongoing trials on HIV PrEP options including other ARV medications and formulations 18
          Optional oral lead-in: CAB 30 mg tablet by mouth daily for at least 28 days
          CAB Injection: Inject 600 mg into gluteal muscle 4 weeks apart for 2 consecutive doses, then administer 600 mg every 8 weeks
          CONT. CONTINUING EDUCATION continued on next page
        PrEP Dosage Toxicity Truvada® (FTC 200 mg/TDF 300 mg) 1 tablet by mouth once daily Immune reconstitution syndrome • Lactic acidosis/hepatomegaly • Decreased bone mineral density • Renal injury • Gastrointestinal (i.e., abdominal pain, diarrhea, nausea) • Descovy® (FTC 200 mg/TAF 25 mg) 1 tablet by mouth once daily Apretude® (CAB-LA 600 mg/3 mL)
        Injection site reactions • Depressive disorders • Hepatotoxicity • Headache • Fatigue • Nausea • Diarrhea • Abdominal pain •
        17
        Table 2. PrEP Dosing and Toxicity13, 14, 15
          
              
              
            
            CONT.
          
              
              
            
            CONTINUING EDUCATION
          PrEP
          Concomitant Medication
          Recommendation
          Cidofovir Closely monitor renal function
          Adefovir Do not coadminister.
          Truvada® (FTC 200 mg/TDF 300 mg)
          Ganciclovir/valganciclovir Monitor for dose-related toxicities.
          Ledipasvir/Sofosbuvir
          Do not coadminister
          Sofosbuvir/Velpatasvir +/- voxilaprevir Monitor for TDF-related adverse events
          Rifabutin
          Rifampin
          Rifapentine
          Adefovir
          Do not coadminister unless bene ts outweigh risks
          Do not coadminister.
          Descovy® (FTC 200 mg/TAF 25 mg)
          Ganciclovir/Valganciclovir Monitor for dose-related toxicities.
          Carbamazepine/Oxcarbamazepine
          Phenobarbital
          Phenytoin
          Do not coadminister
          St. John’s Wort Do not coadminister.
          Rifampin
          Rifapentine
          Apretude® (CAB-LA 600 mg/3 mL)
          Carbamazepine/Oxcarbazepine
          Phenobarbital
          Phenytoin
          Vocabria® (CAB oral 30 mg)
          Contraindicated
          Contraindicated.
          St. John’s Wort Do not coadminister.
          *Same drug interactions as CAB-LA with the following addition
          Aluminum, Magnesium +/- Calciumcontaining Antacids
          Administer antacid products at least 2 hours before or 4 hours after taking CAB PO
          PrEP Average Wholesale Price Generic TDF/FTC $3920.37/56 days supply Truvada® (TDF/FTC) $4126 71/56 days supply Apretude® (CAB-LA) $4506 60/56 days supply Descovy® (TAF/FTC) $4566.99/56 days supply
        Table 3. HIV PrEP Medications Drug Interactions19
          18
        Table 4. Cost of PrEP20, 21, 22
          1 Ready, Set, PrEP: https://readysetprep hiv gov/
          4
          12 Preexposure prophylaxis for the prevention of HIV infection in the United States – 2021 update CDC 2021 Accessed on January 10, 2023 https://www cdc gov/hiv/pdf/risk/prep/cdc-hiv-prep-guidelines-2021 pdf
          13 Descovy (emtricitabine/tenofovir alafenamide) [package insert] Foster City, CA; Gilead Sciences, Inc; Revised 01/2023
          14 Truvada (emtricitabine/tenofovir disoproxil fumarate) [package insert] Foster City, CA; Gilead Sciences, Inc; Revised 06/2020
          15 Apretude (cabotegravir) [package insert] Research Triangle Park, NC; ViiVHealthcare Revised 12/2021
          16 Vocabria (cabotegravir) [package insert] Research Triangle Park, NC; ViiVHealthcare. Revised 1/2021.
          2 Gilead’s Advancing Access Program: https://www gileadadvancingaccess com/
          3 ViiVConnect: https://www viivconnect com/
          References
          1 HIV Historical Timeline U S President’s Emergency Plan for AIDS Relief
          Accessed January 10, 2023 https://hivhistory org/panels/panel-07/
          2 Grant RM, Lama JR, Anderson PL, et al Preexposure chemoprophylaxis for HIV prevention in men who have sex with men N Engl J Med 2010;363(27):2587-2599 doi:10 1056/NEJMoa1011205
          3 Holec AD, Mandal S, Prathipati PK, Destache CJ Nucleotide Reverse Transcriptase Inhibitors: A Thorough Review, Present Status and Future Perspective as HIV Therapeutics Curr HIV Res 2017;15(6):411-421 doi:10 2174/1570162X15666171120110145
          4 Baeten JM, Donnell D, Ndase P, et al Antiretroviral prophylaxis for HIV prevention in heterosexual men and women N Engl J Med 2012;367(5):399410 doi:10 1056/NEJMoa1108524
          5 Hill A, Hughes SL, Gotham D, Pozniak AL Tenofovir alafenamide versus tenofovir disoproxil fumarate: is there a true di erence in e cacy and safety? J Virus Erad 2018;4(2):72-79
          6 Mayer KH, Molina JM, Thompson MA, et al Emtricitabine and tenofovir alafenamide vs emtricitabine and tenofovir disoproxil fumarate for HIV preexposure prophylaxis (DISCOVER): primary results from a randomised, double-blind, multicentre, active-controlled, phase 3, non-inferiority trial Lancet 2020;396(10246):239-254 doi: 10 1016/S0140-6736(20)31065-5
          7. Molina JM, Capitant C, Spire B, et al. On-Demand Preexposure Prophylaxis in Men at High Risk for HIV-1 Infection N Engl J Med 2015;373(23):22372246 doi:10 1056/NEJMoa1506273
          8 Molina JM, Charreau I, Spire B, et al E cacy, safety, and e ect on sexual behaviour of on-demand pre-exposure prophylaxis for HIV in men who have sex with men: an observational cohort study Lancet HIV 2017;4(9):e402-e410 doi:10 1016/S2352-3018(17)30089-9
          9 Dow DE, Bartlett JA Dolutegravir, the Second-Generation of Integrase Strand Transfer Inhibitors (INSTIs) for the Treatment of HIV Infect Dis Ther 2014;3(2):83-102 doi:10 1007/s40121-014-0029-7
          10 Landovitz RJ, Donnell D, Clement ME, et al Cabotegravir for HIV Prevention in Cisgender Men and Transgender Women N Engl J Med 2021;385(7):595608 doi:10 1056/NEJMoa2101016
          11 Delany-Moretlwe S, Hughes JP, Bock P, et al Cabotegravir for the prevention of HIV-1 in women: results from HPTN 084, a phase 3, randomised clinical trial Lancet 2022;399(10337):1779-1789 doi:10 1016/S0140-6736(22)005384
          12 Preexposure prophylaxis for the prevention of HIV infection in the United States – 2021 update CDC 2021 Accessed on January 10, 2023
          https://www cdc gov/hiv/pdf/risk/prep/cdc-hiv-prep-guidelines-2021 pdf
          13 Descovy (emtricitabine/tenofovir alafenamide) [package insert] Foster City, CA; Gilead Sciences, Inc; Revised 01/2023
          14 Truvada (emtricitabine/tenofovir disoproxil fumarate) [package insert] Foster City, CA; Gilead Sciences, Inc; Revised 06/2020
          15 Apretude (cabotegravir) [package insert] Research Triangle Park, NC; ViiVHealthcare. Revised 12/2021.
          16 Vocabria (cabotegravir) [package insert] Research Triangle Park, NC; ViiVHealthcare Revised 1/2021
          17 Pharmacist-initiated PrEP and PEP NASTAD Accessed on January 10, 2023
          https://nastad org/sites/default/ les/2021-11/PDF-Pharmacist-InitiatedPrEP-PEP pdf
          18 PrEP Ongoing Trials AVAC (Global Advocacy for HIV Prevention) Accessed on January 10, 2023 https://www avac org/trialsearch?