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
9
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
1 1 2 2 2
11
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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12
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
12
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?