Fall 2023 Arizona Journal of Pharmacy

Arizona Journal of Pharmacy O F F I C I A L

P U B L I C AT I O N

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A R I Z O N A

P H A R M A C Y

A S S O C I AT I O N

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Kimberly Langley, PharmD, MBA, BCPS, FAzPA

AzPA President 2023-2024

In This Edition: Put Some PrEP in Your Step

Happy American Pharmacists Month!

Legislative Recap

Contents Board of Directors 2023-2024 OFFICERS President Kimberly Langley President-Elect Pro-Tempore Jacob Schwarz Immediate Past President Dawn Gerber Treasurer Ryan Gries Secretary Brandy DeChellis Director/CEO Kelly Fine

COVER STORY pg. 4

DIRECTORS AT LARGE Community Brianne Spaeth Health System Mary Manning Technician Melinda Browning Joseph Pellerito Jimmy Stevens Reasol Chino Misty Brannon Danielle Gilliam LIASIONS University of Arizona Student Chapter David Elias-Campa Dean's Designated Representative Nancy Alvarez Midwestern University Student Chapter Shams Rehman Dean's Designated Representative Michael Dietrich Creighton University Student Chapter Haley DeMartinis Dean's Designated Representative Jane Stein Legal Counsel Roger Morris

AzPA Staff Chief Executive Officer Kelly Fine Education & Professional Development Dawn Gerber Events & Strategic Partnerships Cindy Esquer Membership & Volunteer Services Marques Bottorf Strategic Programs Kristin Calabro Administrative Services Melina Esquer Editor Kelly Fine Creative Coordinator Elizabeth Nelson The interactive digital version of the Arizona Journal of Pharmacy is available for members only online in your member portal.

(480) 838-3385 | admin@azpharmacy.org Editor's Note: Any personal opinions expressed in this magazine are not necessarily those held by the Arizona Pharmacy Association. "Arizona Journal of Pharmacy" (ISSN 1949-0941) is published quarterly by the Arizona Pharmacy Association at: 1845 E. Southern Avenue, Tempe, AZ 85282-5831

President’s Message 4 AzPA News Welcome New Members 5 Az-ASHP State Affiliate News 8 University & Alumni News 21 Arizona Board of Pharmacy Update 30 Editorial Happy American Pharmacists Month 6 AzPA License Bundles are Back 7 Preceptors Corner 10 Auditors Crack Down on Pharmacists that Bypass Plan Limits 27 ASBP Sides with AzPA & Independent Pharmacy Coalition 32 Advocacy Legislative Update 29 Continuing Education Put Some PrEP in Your Step 13

UPCOMING EVENTS

November 4 | Virtual

November 4 | Virtual

November 14-16 | Virtual

February 24-25 | Phoenix, AZ

April 20-21 | Glendale

June 6 | Phoenix, AZ

June 6-9 | Phoenix, AZ

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EDITORIAL PRESIDENT'S MESSAGE Dear AzPA Members,

Kimberly “Kim” Langley, PharmD, MBA, BCPS, FAzPA is the Chief Financial Officer for the DoD Federal Electronic Health Record Modernization office responsible for implementing a single, common federal electronic health record system for Department of Defense, Department of Veteran Affairs, 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 Officer 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 Certificate in Business Process Management from Villanova University. She is also boardcertified 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 certificate programs, abstract peer reviewer, and conference speaker. Her leadership experience extends to various roles on multiple USPHS committees, workgroups, and mentoring programs.

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 reflect 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 first-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 office 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 efforts 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 effort 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 first 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!

Kimberly “Kim” Langley, PharmD, MBA, BCPS, FAzPA 2023-2024 AzPA President

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WELCOME NEW MEMBERS! 2nd Year Practitioner

Mohanad Znbaqa Pharmacist

Kathleen Brakebush Olivia Brandner Jacqueline Campbell Chandima Deegala Nate Evans Derek Fomba Shannon Griffith 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

Geoffrey Boadu Charles Case Shauna Geis Vanessa Gervais Myra James Ashley Merrick Sharon Miller Kadean Perrone Annette Wright-Smith

Resident

Jeffrey 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

AZPA NEWS 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

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EDITORIAL PHARMACISTS MONTH

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

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.

Nominate Your 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 12: Woman Pharmacist Day • October 15-21: National Pharmacy Week • October 17: Pharmacy Technician Day

Thursday, October 12

CELEBRATE WITH US!

October 15 - October 21

Tuesday, October 17

RSVP Here!

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EDITORIAL PHARMACISTS MONTH

AZPA LICENSE RENEWAL BUNDLES ARE BACK! Still need CE for your renewal? We've got you covered!

These License Renewal Bundles are a cost-effective 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 offered 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

Learn More!

Have Questions about Renewal Requirements?

Skip to the Arizona Board of Pharmacy Update to learn more!

Go to Page 30

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AZ-ASHP AFFILIATE NEWS

Mary Manning, PharmD, MBA, BCPS AzPA Board of Directors-Health System

AzPA HEALTH SYSTEM SPECIAL INTEREST GROUP (AZ-ASHP) I’d like to start off 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 off, 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 affiliate chapter’s annual meeting. At our monthly SIG meetings, we want to hear from you regarding topics that you find interesting and would like to learn more about.

Respectfully,

Mary Manning, PharmD, MBA, BCPS AzPA Board of Directors-Health System

Learn More Here

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EDITORIAL PRECEPTOR CORNER

Tailoring Rotation Experiences for Unique Learner Needs AUTHORS/CONTRIBUTORS Laura Hanson, PharmD, BCGP, Quality Assurance Site Visitor, Department of Pharmacy Practice, Midwestern University College of Pharmacy

Suzanne Larson, PharmD, Director of Experiential Education, Department of Pharmacy Practice, Midwestern University College of Pharmacy Janet Cooley, PharmD, BCACP Director of Experiential Education, Department of Pharmacy Practice and Science, R. Ken Coit College of Pharmacy, University of Arizona DISCLOSURE The author(s) declare no real or potential conflicts or financial interest in any product or service mentioned in the manuscript, including grants, equipment, medications, employment, gifts, and honorarium.

FUNDING No funding was provided.

ACKNOWLEDGEMENT The author gratefully acknowledges all pharmacy practice preceptors dedicated to providing high quality learning experiences.

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CONT. PRECEPTOR CORNER Experiential rotations offer learners many opportunities for professional and personal development. Each learner is unique with varied interests and backgrounds and may benefit from specific activities and experiences to gain full benefit 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 specific 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 first 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.1 The concept of meshing may be of benefit, but literature is not yet conclusive about recommendations for employing meshing as an effective teaching strategy.1 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”.2 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 reflection by the resident on career goals, practice interests, and well-being and resilience”.2 Based on this individualized reflection, 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”.2 How can I tailor a rotation to my individual learner’s needs?

Get to know your learner The first step in tailoring rotations effectively 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 modifications of core competencies Once the individual characteristics and needs of the learner are clear, preceptors can then reflect 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 find personal fulfillment and motivation through rotation tailoring.

While this example is specific 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 specific 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.4 There are many ways to approach rotation tailoring and specific 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, modifications 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 beneficial opportunities. In addition to addressing essential requirements from accrediting bodies, practicing rotation customization allows for reflection and self-awareness on the part of learners.

Preceptors and sites also benefit from the increased fulfillment 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. American Journal of Pharmaceutical Education ;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-effective-July-2023.pdf. Accessed Sept 11 2023.

4. Larson S, Cooley J, Griffin 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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CONTINUING EDUCATION

Put Some PrEP in Your Step AUTHORS/CONTRIBUTORS

Connie Liang, PharmD, University of Maryland School of Pharmacy Neha Pandit, PharmD, BCPS, AAHIVP, University of Maryland Baltimore School of Pharmacy FUNDING - This research was not funded DISCLOSURES - The authors have no relevant financial relationship to disclose 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 Maryland Pharmacist's Spring 2023 issue.

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CONT. CONTINUING EDUCATION Background In the early 1980s, the first cases of acquired immunodeficiency 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 first antiretroviral (ARV) medication was approved, and the subsequent use of highly active ARV led to a significant decline in AIDS-related deaths.1 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 immunodeficiency virus (HIV) for men who have sex with men (MSM) and individuals who have heterosexual sex.2 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.1 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 differ 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.3 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 effectiveness of oral PrEP.2 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 significant lower risk of HIV-1 infection.4 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 findings, TAF 25 mg once daily is bioequivalent to TDF 300 mg once daily.5 The DISCOVER trial was a randomized, double-blinded, noninferiority trial to assess the safety and efficacy 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 effects. However, the FTC/TAF was found to have less bone mineral density loss and less renal function decline compared to FTC/TDF.6 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 conflicting results but is an available option based on the studies that demonstrated efficacy.7, 8 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.9 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 efficacy 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 differences in the frequency of grade two or higher adverse events between the groups including decreased creatinine clearance, increased creatine kinase, and nasopharyngitis. One significant difference 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 group discontinued the injection due to the ISRs.10 The HPTN 084 trial was a randomized, double-blind superiority trial to evaluate the safety and efficacy 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 difference in adverse effects 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 effective and safe for HIV prevention in women.11 These two trials showed that CAB-LA was effective 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 benefits 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.12 Table 1. PrEP Studies Study

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.12 Individuals who have any of these risk factors should be offered 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 benefits.

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 specifically excludes patients who are at risk from receptive vaginal sex as this population was not evaluated in the clinical trials.13 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.13, 14 Sample Size

Median Follow up Time Period

Outcomes

Placebo women FTC/TDF 200/300 mg Transgender who have sex with men

2499 participants

1.2 years

Hazard ratio 0.56 (95% CI, 0.37 to 0.85)

Placebo TDF 300 mg FTC/TDF 200/300 mg

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)

86 weeks

Incidence rate ratio 0.47 (95% CI, 0.19 to 1.15) between FTC/TAF and FTC/TDF

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)

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

Drug/Dosing

Population

MSM iPrEx

study3

The PrEP study5

East African heterosexual men and women MSM

DISCOVER8

FTC/TAF 200/25 mg women FTC/TDF 200/300 mg Transgender who have sex with men

5387 participants

MSM HPTN 08310

CAB-LA 600 mg IM women FTC/TDF 200/300 mg Transgender who have sex with men

HPTN 08411

CAB-LA 600 mg IM FTC/TDF 200/300 mg

Women who have vaginal intercourse

4566 participants

3224 participants

CONT. CONTINUING EDUCATION For both medications, it is imperative to confirm 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 first PrEP prescription. Subsequently, patients must provide confirmatory 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.12 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.12 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.13, 14 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.12 Injectable HIV 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).15, 16 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 first two injections followed by injections every 8 weeks thereafter. Patients may receive their injection one week prior or one week after their

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 confirm 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.12 Since adherence is crucial for efficacy and prevention of resistance, it is important to ensure patients are ideal candidates CAB-LA use. Some adverse effects that can occur include ISRs, diarrhea, headache, fatigue, nausea, and abdominal pain.15 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.12 Pharmacy-Initiated PrEP There are regions in the United States and globally where individuals face multiple barriers to adequate PrEP including financial difficulties, 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 confirmatory tests for patients. Although the bill was not passed similar bills may be introduced in future legislative sessions.17 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 effects, 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.

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CONT. CONTINUING EDUCATION 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 identifies 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 efficacy 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 patientspecific 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 effect 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 efficacious with good tolerability. The decision on which agent to start for PrEP is dependent on patient-specific factors including medical conditions, cost, and adherence. This also involves shared decision-making regarding the risks and benefits of preventative treatment. Currently, there are numerous ongoing trials on HIV PrEP options including other ARV medications and formulations.18

Table 2. PrEP Dosing and Toxicity13, 14, 15 PrEP

Dosage

Truvada® (FTC 200 mg/TDF 300 mg)

1 tablet by mouth once daily

Toxicity

• 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

Optional oral lead-in: CAB 30 mg tablet by mouth daily for at least 28 days Apretude® (CAB-LA 600 mg/3 mL)

CAB Injection: Inject 600 mg into gluteal muscle 4 weeks apart for 2 consecutive doses, then administer 600 mg every 8 weeks

• Injection site reactions • Depressive disorders • Hepatotoxicity • Headache • Fatigue • Nausea • Diarrhea • Abdominal pain

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CONT. CONTINUING EDUCATION Table 3. HIV PrEP Medications Drug Interactions19 PrEP

Truvada® (FTC 200 mg/TDF 300 mg)

Concomitant Medication

Recommendation

Cidofovir

Closely monitor renal function.

Adefovir

Do not coadminister.

Ganciclovir/valganciclovir

Monitor for dose-related toxicities.

Ledipasvir/Sofosbuvir

Do not coadminister.

Sofosbuvir/Velpatasvir +/- voxilaprevir

Monitor for TDF-related adverse events.

Rifabutin Rifampin Rifapentine Descovy® (FTC 200 mg/TAF 25 mg)

Adefovir

Do not coadminister.

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)

Do not coadminister unless benefits outweigh risks.

Contraindicated

Carbamazepine/Oxcarbazepine Phenobarbital

Contraindicated.

Phenytoin St. John’s Wort Vocabria® (CAB oral 30 mg)

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.

Table 4. Cost of PrEP20, 21, 22 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

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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; Table 5. PrEP Coverage Resources23, 24, 25 ViiVHealthcare. Revised 12/2021.

16. Vocabria (cabotegravir) [package insert]. Research Triangle Park, NC; ViiVHealthcare. Revised 1/2021.

1. Ready, Set, PrEP: https://readysetprep.hiv.gov/ 17. Pharmacist-initiated PrEP and PEP. NASTAD. Accessed on January 10, 2023. https://nastad.org/sites/default/files/2021-11/PDF-Pharmacist-Initiated2. Gilead’s Advancing Access Program: https://www.gileadadvancingaccess.com/ PrEP-PEP.pdf 3. ViiVConnect: https://www.viivconnect.com/ 18. PrEP Ongoing Trials. AVAC (Global Advocacy for HIV Prevention). Accessed on January 10, 2023. https://www.avac.org/trialsearch? field_prevention_option_tid%5B%5D=4&keys=&title=&field_status_value=All References &field_phase_value=All 19. Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents 1. HIV Historical Timeline. U.S. President’s Emergency Plan for AIDS Relief. with HIV. Department of Health And Human Services. 2023. Accessed on Accessed January 10, 2023. https://hivhistory.org/panels/panel-07/ March 31, 2023. https://clinicalinfo.hiv.gov/en/guidelines/hiv-clinical2. Grant RM, Lama JR, Anderson PL, et al. Preexposure chemoprophylaxis for guidelines-adult-and-adolescent-arv/whats-new HIV prevention in men who have sex with men. N Engl J Med. 20. Active Ingredient: Emtricitabine/tenofovir disoproxil fumarate. RED BOOK 2010;363(27):2587-2599. doi:10.1056/NEJMoa1011205 Online. IBM Micromedex [database online]. Truven Health Analytics/IBM 3. Holec AD, Mandal S, Prathipati PK, Destache CJ. Nucleotide Reverse Watson Health; 2020. Accessed January 23, 2023.

Transcriptase Inhibitors: A Thorough Review, Present Status and Future https://www.micromedexsolutions.com Perspective as HIV Therapeutics. Curr HIV Res. 2017;15(6):411-421.

21. Active Ingredient: Emtricitabine/tenofovir aladenamide. RED BOOK Online. doi:10.2174/1570162X15666171120110145 IBM Micromedex [database online]. Truven Health Analytics/IBM Watson 4. Baeten JM, Donnell D, Ndase P, et al. Antiretroviral prophylaxis for HIV Health; 2020. Accessed January 23, 2023. prevention in heterosexual men and women. N Engl J Med. 2012;367(5):399https://www.micromedexsolutions.com 410. doi:10.1056/NEJMoa1108524 22. Active Ingredient: Cabotegravir. RED BOOK Online. IBM Micromedex 5. Hill A, Hughes SL, Gotham D, Pozniak AL. Tenofovir alafenamide versus [database online]. Truven Health Analytics/IBM Watson Health; tenofovir disoproxil fumarate: is there a true difference in efficacy and 2020. Accessed January 23, 2023. https://www.micromedexsolutions.com safety?. J Virus Erad. 2018;4(2):72-79.

23. Ready, set, PREP: Find out if you qualify for enroll for free PrEP medications.

6. Mayer KH, Molina JM, Thompson MA, et al. Emtricitabine and tenofovir Department of health and human services. Accessed on January 10, 2023. alafenamide vs emtricitabine and tenofovir disoproxil fumarate for HIV prehttps://readysetprep.hiv.gov/ exposure prophylaxis (DISCOVER): primary results from a randomised, 24. Gilead’s Advancing Access Program. Gilead. Accessed on January 10, 2023. double-blind, multicentre, active-controlled, phase 3, non-inferiority trial. https://www.gileadadvancingaccess.com/ Lancet. 2020;396(10246):239-254. doi: 10.1016/S0140-6736(20)31065-5 25. ViiVConnect. Accessed on January 10, 2023. https://www.viivconnect.com/ 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 Active Learning Patient Case 8. Molina JM, Charreau I, Spire B, et al. Efficacy, safety, and effect on sexual behaviour of on-demand pre-exposure prophylaxis for HIV in men who GC is a 48-year-old-female who presents to clinic for HIV have sex with men: an observational cohort study. Lancet HIV. preexposure prophylaxis (PrEP) initiation. She states that she 2017;4(9):e402-e410. doi:10.1016/S2352-3018(17)30089-9 has receptive vaginal sex with her male partner and uses 9. Dow DE, Bartlett JA. Dolutegravir, the Second-Generation of Integrase condoms around 30% of the time. She is unaware of her male Strand Transfer Inhibitors (INSTIs) for the Treatment of HIV. Infect Dis Ther. partners HIV status. She has heard about PrEP from her friends 2014;3(2):83-102. doi:10.1007/s40121-014-0029-7 and is interested in starting on medication. She has no 10. Landovitz RJ, Donnell D, Clement ME, et al. Cabotegravir for HIV Prevention preference on route of administration. She has insurance in Cisgender Men and Transgender Women. N Engl J Med. 2021;385(7):595through her job.

608. doi:10.1056/NEJMoa2101016 11. Delany-Moretlwe S, Hughes JP, Bock P, et al. Cabotegravir for the prevention Pertinent objective data from 5 days ago 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)00538Weight: 48 kg 4 CrCl: 29 mL/min 12. Preexposure prophylaxis for the prevention of HIV infection in the United HBV Surface Ab: positive States – 2021 update. CDC. 2021. Accessed on January 10, 2023.

HBV Surface Ag: negative https://www.cdc.gov/hiv/pdf/risk/prep/cdc-hiv-prep-guidelines-2021.pdf HBV Core Ab: negative 13. Descovy (emtricitabine/tenofovir alafenamide) [package insert]. Foster City, HIV Ag/Ab: negative CA; Gilead Sciences, Inc; Revised 01/2023.

HIV RNA: < 20 copies/ml 14. Truvada (emtricitabine/tenofovir disoproxil fumarate) [package insert].

HCV Ab: positive Foster City, CA; Gilead Sciences, Inc; Revised 06/2020.

15. Apretude (cabotegravir) [package insert]. Research Triangle Park, NC; 1. All of the following are reasons for why GC is a good candidate ViiVHealthcare. Revised 12/2021. for HIV PrEP initiation except: 16. Vocabria (cabotegravir) [package insert]. Research Triangle Park, NC; a. Has receptive vaginal sex.

ViiVHealthcare. Revised 1/2021. b. Does not always use condoms.

17. Pharmacist-initiated PrEP and PEP. NASTAD. Accessed on January 10, 2023. c. Does not know the HIV status of her sexual partner. https://nastad.org/sites/default/files/2021-11/PDF-Pharmacist-Initiatedd. Has HCV antibodies.

PrEP-PEP.pdf 18. PrEP Ongoing Trials. AVAC (Global Advocacy for HIV Prevention). Accessed 2. Which medication would be the most appropriate to initiate on January 10, 2023. https://www.avac.org/trialsearch? for GC? field_prevention_option_tid%5B%5D=4&keys=&title=&field_status_value=All a. Emtricitabine/tenofovir alafenamide &field_phase_value=All b. Emtricitabine/tenofovir disoproxil fumarate 19. Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents c. Cabotegravir intramuscular injection with HIV. Department of Health And Human Services. 2023. Accessed on d. Cabotegravir/rilpivirine March 31, 2023. https://clinicalinfo.hiv.gov/en/guidelines/hiv-clinicalAnswers on next page guidelines-adult-and-adolescent-arv/whats-new

CONT. CONTINUING EDUCATION

19

CONT. CONTINUING EDUCATION Active Learning Patient Case Explained Answers 1. Answer D Individuals who are sexually active (i.e., anal or vaginal sex) and/or inject drugs are good candidates for HIV PrEP. For individuals who either do not or inconsistently use condoms are at a higher of acquiring HIV infection and would also be good candidates for HIV PrEP. When the HIV status of the sexual partner is unknown, it puts the individual at risk because if the sexual partner is HIV-positive, then the individual has an extremely high risk of also acquiring HIV-infection. Having HCV antibodies does not make an individual a good candidate for HIV PrEP initiation because none of the medications used for HIV PrEP has activity against hepatitis C and patients with or without hepatitis C can be on HIV PrEP. 2. Answer C Emtricitabine/tenofovir alafenamide is incorrect because it has not been studied in heterosexual women who have sex with men. It is also not recommended because her CrCl is less than 30 mL/min. Emtricitabine/tenofovir disoproxil fumarate is incorrect because use is not recommended in patients with CrCl less than 60 mL/min. Cabotegravir intramuscular injection is correct because there is no renal dose adjustment. Cabotegravir/rilpivirine is incorrect because that is used for HIV-positive patients and is not an approved HIV PrEP.

CONTINUING EDUCATION INFORMATION AzPA Members may retrieve FREE CE for this article up to one year after the program release date.

This program provides 1.0 contact hours of continuing education credit.

Accredited Date: 05/30/2023 Expiration Date: 05/30/2026 Universal Activity Number (UAN) is: 278-0000-23-018-H02-P/T Apply for credit here: https://www.lecturepanda.com/r/PutSomePrEPinYourStepMPhA

The Virginia Pharmacy Association is accredited by the Accreditation Council for Pharmacy Education as providers of continuing education.

20

EDITORIAL UNIVERSITY & ALUMNI

Rick G. Schnellmann, PhD Dean, University of Arizona College of Pharmacy

Alumna Nicole Henry empowering health care from two directions A passion for health care began early for Nicole Henry, PharmD, an assistant professor of practice at the University of Arizona R. Ken Coit College of Pharmacy.

That passion was moved to reality though when tragedy showed her where she could help her community the most.

A career in health care always seemed to be in her future. In high school, she delivered meals to a senior center and volunteered in a hospice program, where she came to know many of the medications the patients were taking. She had the opportunity to attend a pharmacy conference and became even more fascinated by how the interplay of different drugs could produce different results, and how those results could differ from one person to another.

Ultimately, however, it was that tragic event that solidified her choice of career. As an undergraduate bioscience major at Arizona State University, a family friend she’d been helping care for suffered a brain hemorrhage and fall due to a severe interaction between two medications. That friend passed away as a result, and for Henry, his death made clear her way forward: she would pursue pharmacology with a goal of providing medication counseling and education as a pharmacist.

Patient-centered care After graduating from ASU, she hit the ground running.

In 2013 - her first year as a student at the Coit College of Pharmacy - Henry noticed the college didn’t have a student chapter of the American Society of Consultant Pharmacists, so she took the initiative to start one. The group organized on-site consultation sessions with interdisciplinary teams drawn from the four UArizona Health Sciences colleges in Tucson, helping older adults better understand their medications and communicate with their doctors.

Those early experiences made her realize she could have the greatest impact on the health care system by working for change from two directions – first as a district leader for CVS Health where she is responsible for oversight, hiring, onboarding and talent development and second in teaching the Introduction to Pharmacy Practice course at the College of Pharmacy in Phoenix.

In addition to teaching, she delivers guest lectures in management courses, sharing her expertise and insights as a working pharmacist and industry leader.

It’s not a common combination: Of the more than 40,000 physicians, pharmacists, nurses and nurse practitioners that CVS Health employs, Henry alone melds those two worlds.

The perspective from front-line pharmacy has shaped Henry’s teaching to focus on patient-centered care. For example, working with older adults, she has frequently encountered polypharmacy, in which patients are prescribed multiple medications to treat a single condition, such as high cholesterol, high blood pressure or various heart problems. As a professor, she emphasizes the importance of simplifying medication regimens by reducing duplication and exploring combination therapies.

COVID-19 also brought important lessons that inform her teaching. During the pandemic, she helped organize rapid mobilizations of pharmacists, but also witnessed widespread resistance to, and confusion around, vaccines. The experience made her a staunch advocate for improving patient communication and messaging, as well as for everyday issues such as dosing intervals and adherence to a prescribed regimen.

From her days as a graduate student to today as an assistant professor of practice at the R. Ken Coit College of Pharmacy, Nicole Henry, PharmD, has stepped up when her community needed her. Whether it was launching a student chapter of the American Society of Consultant Pharmacists or working to ensure her students had awareness of polypharmacy, in which patients are prescribed multiple medications to treat a single condition, Henry finds a way to make an impact.

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CONT. UNIVERSITY & ALUMNI “It’s really about how you communicate with patients to make sure that they understand where you're coming from,” Henry said. “Are we thinking through how patients are going to perceive messaging? Are we creating simplicity so they can truly understand us? I want my students to look at health care through the lens of both the patient side and the business side, because all of it needs to come together for care to be successful.”

“Top of license” pharmacy Henry argues that pharmacists should be recognized as health care providers at the federal level. Today, each state determines the professional activities allowed for licensed pharmacists, but provider status is a federal legal designation that would dramatically change the national calculus of health care delivery and economics.

For example, pharmacists cannot be reimbursed under Medicare Part B for providing health care services to patients. Nearly every other category of licensed care providers – including audiologists, social workers and dieticians – receive these reimbursements.

Champions for federally recognized provider status cite research demonstrating that when pharmacists have greater roles in health care, not only does the overall cost of care decrease, patients have better outcomes and express higher satisfaction.

In health care, this idea of optimizing capacity is captured in the phrase “working at top of license,” the concept that employees at any level should spend their time on tasks that require the full extent of what they know, not doing what could be done by someone who doesn’t have their education and training. Straddling teaching and industry, Henry sees the issue as a pervasive disservice to communities, as well as to the pharmacists who serve them. “Most are doing just a very small portion of what they went to school for,” she said. “They've been trained to do more. They want to do more. When pharmacists can work at the top of their license, people can come to them for basic health needs, and we can help them solve those issues very quickly.”

Henry points out that pharmacists are today’s most accessible health care practitioners. A recent peerreviewed academic study found that roughly 89% of the U.S. population lives within five miles of a community pharmacy, and roughly 97% live within 10 miles of one. Given their extensive training and education, expanding pharmacists’ role in health care delivery could dramatically increase access to routine care. “That ease of care and accessibility – I think that's where pharmacists provide the most value," Henry said.

Coming full circle Today, Henry’s work has come full circle, even as it continues to break new ground. Where she was once the student organizing consultation clinics at assisted living homes (and throwing them sock-hop fundraisers), she now mentors a new generation of learners into the community to set up clinics and volunteer at health fairs, where they provide free diabetes assessments, cholesterol checks, HIV/AIDS screening, depression awareness education and other services.

Nothing in a classroom replaces the practical education that arises in those unscripted, hands-on, real-world settings: critical thinking and problem-solving, but just as importantly learning to listen, relate and build connections. For Henry, it always comes back to patient-centered care: giving people the knowledge and tools to be the agents of their own well-being.

There is no greater feeling, she said, than when hearing someone from a clinic tell her, as one recently did: For the first time ever, I feel empowered to ask my doctor questions. I feel empowered because of the work that you and your students have done with me.

"I’m excited about the future of pharmacy,” Henry said.

“We can really make a difference for our patients through interventions that are just very, very simple, but first we need to build trust with every patient. They need to know we’re there to provide education to them in a way they can understand and that our job is to make sure that they're safe and healthy and protected.”

Expanded roles for pharmacists could also solve problems for the nation’s increasing strain on a toosmall workforce of physicians. The Association of American Medical Colleges estimates that the U.S. could face a shortage of more than 120,000 physicians by the end of this decade. When the UArizona Coit College of Pharmacy and College of Nursing recently joined forces to offer a dual-degree program combining the PharmD with advanced nursing degrees, it was partly to help address this looming crisis.

22

EDITORIAL UNIVERSITY & ALUMNI

Midwestern University College of Pharmacy Mitchell R. Emerson, PhD Dean, Midwestern University College of Pharmacy

Greetings from the College of Pharmacy at Midwestern University!

As we welcome fall, we also celebrate the many accomplishments of our students, faculty, and alumni.

In June, we welcomed our newest class and wished them success as they took their next steps to becoming an exceptional pharmacist. The Class of 2026 is comprised of students from all over the nation, with 46% from Arizona and 14% from California.

These students have a variety of backgrounds, talents, and passions that make the College of Pharmacy a uniquely diverse and enriching place to be!

On September 13 at 5:00pm, we’ll be hosting the College of Pharmacy Alumni/First Year Students Ice Cream social on campus in Cholla Hall. Thank you to our incredible alumni for sharing their stories and offering our newest students mentoring.

On Sunday, December 3, we’ll be hosting the College of Pharmacy Alumni and Friends reception in Anaheim in conjunction with the American Society of Health System Pharmacists (ASHP) conference. If you’re able to join us, please reach out to Kimberly at KHastings@midwestern.edu and look for details in your email.

Did you know we have a Midwestern University Job Board? If you’re looking to hire or looking for a new opportunity, please click here for more information https://www.midwestern.edu/alumni/alumni-job-finder.

We are looking forward to catching up with all of you and connecting at a future event. If you’re ever back in the Glendale area, please reach out and stop by the campus. So much has changed, but still remains the same welcoming place.

If you’ve recently moved or relocated, please ensure we have your updated contact information. Please email updates to your Manager of Alumni Relations, Kimberly Hastings at KHastings@midwestern.edu To follow us and learn more about our events and wins, join the MWU Pharmacy social media community: Like us on Facebook: Midwestern University-College of Pharmacy Follow us on Twitter: @MWUpharmacy Follow us on Instagram: @MWUpharmacy

23

EDITORIAL UNIVERSITY & ALUMNI

Creighton University College of Pharmacy Jane Stein, PharmD Assistant Professor, Creighton University College of Pharmacy

Service-learning guides Phoenix pharmacy students The pharmacy program at Creighton University’s Phoenix campus welcomed its third class this year, which continues the University’s commitment to satisfying a growing need for pharmacists in Arizona and beyond.

The arrival of the new students marked a highlight in a year that saw current students continue a tradition of service locally and abroad and saw all faculty members present continuing education sessions at the 2023 Arizona Pharmacy Association’s Annual Convention.

America’s evolving healthcare challenges demand a vigorous response, and the Creighton University School of Pharmacy and Health Professions provides that response by producing a well-prepared workforce to serve the state’s healthcare needs.

much more than extracurricular activities. They are essential facets of a Creighton pharmacy education.

“Through service, they bridge the gap between theory and practice,” says Yousef Toma, PharmD, BCPS, CSP, AAHIVP, assistant professor at the Creighton School of Pharmacy and Health Professions. “They apply their pharmaceutical knowledge to improve the lives of vulnerable populations. This hands-on experience enriches their education by demonstrating the realworld impact of their chosen field.”

Creighton University has been educating passionate, capable pharmacists in the Jesuit, Catholic tradition since 1905. It brought that tradition to Phoenix in 2021 when the new $100 million, 195,000-square-foot Creighton University Health Sciences Campus opened at 3100 N. Central Ave., in midtown Phoenix.

Yousef Toma, PharmD, BCPS, CSP, AAHIVP

Creighton in the Global Community That approach to service expresses itself internationally in Creighton’s pharmacy program. This year, two pharmacy students and Jane Stein, PharmD, assistant professor of pharmacy practice, embarked on an international experience in the Dominican Republic.

There, together with Creighton’s service partner of 50 years, the Institute for Latin American Concern, the students witnessed healthcare disparities firsthand and actively contributed to addressing them.

Creighton in the Phoenix Community Creighton’s faculty and pharmacy students in Phoenix eagerly anticipate continuing their service work at St. Vincent de Paul Clinic and First Place, where housing is provided to adults with autism. These commitments are

“Such international experiences broaden their horizons and fosters cultural competence, preparing them to be socially responsible global citizens,” says Toma.

Creighton in the Pharmacy Community Additionally, all three of the Phoenix faculty members presented continuing education sessions at the 2023 Arizona Pharmacy Association’s Annual Convention

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EDITORIAL UNIVERSITY & ALUMNI held June 22-25 in Tucson. Their participation underscores the program's dedication to fostering professional growth and staying at the forefront of pharmaceutical education and practice in the state.

Notably, Toma received the prestigious Distinguished Young Pharmacist Award from the Arizona Pharmacy Association, a well-deserved recognition of his exceptional contributions to the field.

One of three pathway options to a Creighton Doctor of Pharmacy credential, the Phoenix PharmD program is a hybrid of online and in-person education.

Pharmacy students in Phoenix use Creighton’s innovative distance learning technology to view lectures online at times that work best for them and attend the Phoenix campus for the hands-on portion of the curriculum throughout the academic year.

Creighton has had a healthcare presence in Phoenix since 2007. When the University’s regional partners asked Creighton to expand and help meet the growing need for compassionate healthcare professionals, the University answered the call by forming the Creighton University Arizona Health Education Alliance, which includes Dignity Health St. Joseph’s Hospital and Medical Center, Valleywise Health and District Medical Group, Inc. The alliance enables Creighton students to gain hands-on experience in these prominent Phoenix healthcare facilities.

Creighton was the first university in the United States to offer an online Doctor of Pharmacy program, and since the program launched in 2001, the University has remained on the leading edge of distance education.

LEARN MORE!

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NEW ON-DEMAND PROGRAM! Pharmacist-Directed Hormonal Contraception Training The Arizona Pharmacy Association is happy to announce that 2 years after the passage of SB1082 Arizona pharmacists can now dispense Self-Administered Hormonal Contraceptives to women 18 years and older pursuant to the newly adopted ADHS Statewide Standing Order!

Any pharmacist wishing to dispense self-administered hormonal contraceptives pursuant to this statewide Standing Order must be prepared to do the following: Complete a 3-hour Training -AzPA has created one that is compliant with ARS 32-1979.01 and AAC R4-23-407 and R4-23-408-409.

Obtain necessary equipment to measure blood pressure.

Review the Standing Order, Standard Procedures, and Self-Screening Questionnaire.

Establish SOP’s to ensure your pharmacy is compliant with all state laws.

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EDITORIAL PAAS NATIONAL

Auditors Crack Down on Pharmacies That Bypass Plan Limits PAAS National® analysts want to warn pharmacies about an uptick in PBMs flagging prescriptions for bypassing plan limit rejects. These prescriptions are being marked as discrepant and face full recoupment.

Share this information with your staff and ensure that claims are not unintentionally being put at risk for audit/recoupment.

When pharmacies receive a reject of plan limit or exceeds maximum daily dose, pharmacy staff must follow the plan guidelines to submit the claim appropriately. The plan sending this rejection is telling the pharmacy that the dosage is not covered without additional requirements. This could mean prior authorization, switching to a different dose, or changing to another medication.

Pharmacies that manipulate the days’ supply to bypass the rejection are putting those claims at risk of recoupment. PBMs can easily track when pharmacies run a claim, receive a reject, and immediately rebill for the same quantity but different days’ supply. This raises a red flag that the plan reject was likely not adhered to appropriately – low hanging fruit for PBM auditors.

Reducing the quantity and/or split billing prescriptions can also be an audit risk. If a reduced quantity is submitted to bypass the plan limit (e.g., to get under a dollar threshold), the claim is still in jeopardy of being recouped. Beyond circumventing a plan limit, the payor

may argue it increased costs through additional refills, dispensing fees, and patient copays. One patient complaint to their plan could lead to big trouble for network pharmacies.

PAAS Tips: • Always bill the accurate days’ supply based on the instructions for use indicated on the prescription • Make sure all staff are instructed to follow plan rejects appropriately and not change the days’ supply to get a paid claim • Check with the PBM help desk for guidance on rejects that are vague or unclear • Do not split bill rejected claims ◦ Charging the patient cash often leads to complaints [from the patient to an employer or PBM] and can be considered non-compliance with the provider manual and lead to remediation, including potential network termination ◦ If you have exhausted all plan options and the patient insists on paying cash for the full prescription, be sure that you document authorization from the patient that they desired to pay the full cost and did not want to wait for the proper channels • If having difficulties with prescribers following through on prior authorization, enlist the patient to help. The patient could contact the prescriber and/or file a complaint with their insurance which may speed up the process.

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CONT. PAAS NATIONAL PAAS National® is committed to serving community pharmacies and helping keep hard-earned money where it belongs. Contact PAAS today at (608) 873-1342 or info@paasnational.com to see why PAAS Audit Assistance membership might be right for you.

By Trenton Thiede, PharmD, MBA, President at PAAS National®, expert third party audit Assistance and FWA/HIPAA compliance.

Copyright © 2023 PAAS National, LLC. Unauthorized use or distribution prohibited. All use subject to terms at https://paasnational.com/terms-of-use/.

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Join the Legislative Committee!

We meet on the 3rd Thursdays of the month at 7:00 a.m.

ADVOCACY LEGISATIVE UPDATE

Apply Here

Legislative Update Pharmacist Directed Hormonal Contraceptives (Effective July 5, 2023) The Arizona Pharmacy Association is happy to announce that 2 years after the passage of SB1082 Arizona pharmacists can now dispense Self-Administered Hormonal Contraceptives to women 18 years and older pursuant to the newly adopted ADHS Statewide Standing Order that went into effect on July 5, 2023!

Any pharmacist wishing to dispense selfadministered hormonal contraceptives pursuant to this statewide Standing Order must be prepared to do the following: 1. Complete a 3-hour Training -AzPA has created one that is compliant with ARS 32-1979.01 and AAC R4-23-407 and R4-23-408-409. This ondemand training will be available on July 7th at 5pm. Training link: https://www.lecturepanda.com/a/PharmacistDir ectedHC 2. Obtain necessary equipment to measure blood pressure and calculate BMI. 3. Review and comply with the Standing Order, Standard Procedures, and Self-Screening Questionnaire. https://www.azdhs.gov/prevention/womenschildrens-health/womenshealth/index.php#family-planning 4. Establish SOP’s to ensure your pharmacy is compliant with all state laws.

Technician Immunization Administration (Effective September 6, 2023) The Arizona Pharmacy has been working with the Board of Pharmacy rules writing task force for the past 2 years on a rule package to allow technicians to administer vaccines under a pharmacist supervision and those finally went into effect on September 6, 2023.

According to AAC R4-23-1104 (B5) technicians can administer a vaccine when: • Administration of the vaccine is done under an

order that complies with ARS 32-1974 and R423-411; • Administration of the vaccine is delegated by and done under the supervision of a pharmacist on duty who is certified under ARS 32-1974 to administer vaccines; and • There is documentation by the permittee that the pharmacy technician has completed the following: • A practical training program that is approved

by ACPE and includes hands-on-injection and recognition and treatment of emergency reactions to vaccines; and • Current certification in basic CPR NOTE: If you work within a community pharmacy chain or health system you should defer to your supervisor for details on planned rollout and applicable SOP’s.

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NEWS EDITORIAL

BOARD OF PHARMACY

Arizona State Board of Pharmacy Update BOARD MEMBERS Lorri Walmsley RPh, President Tenille Davis, PharmD, Vice President Cedar Lahann,PharmD, RPh, Member Kevin Dang, PharmD, RPh, Member Kristen Snair, CPhT, Member Frank Thorwald, Member (Public) Vacant, Member Vacant, Member Vacant, Member (Public)

ONLINE RENEWAL CYCLE The online renewal cycle will begin on September 5, 2023, at 00:01 MST and end on November 1, 2023, at 23:59 MST. Renewals submitted after November 1, 2023, are subject to a late renewal penalty. You may renew by logging into your online profile here.

Please Note: A person shall not apply for a license renewal more than sixty days before the expiration date of the license.

CE REQUIREMENTS FOR 2023 RENEWAL PHARMACISTS 30 total continuing education (“CE”) hours are required for renewal: DESCRIPTION

NUMBER

STATUTE/RULE

Opioid-related, substance use disorder-related, or addiction related continuing education activities.

Three (3) of the thirty (30) CE hours required for renewal.

A.R.S. 32-3248.02

Immunizers: CE related to administering Immunizations, vaccines, and emergency medications.

Two (2) of the thirty (30) CE hours required for renewal.

A.A.C. R4-23-204(A)(2)(a)

Pharmacists who prescribe and dispense tobacco cessation drug therapies: CE related to tobacco cessation.

Two (2) of the thirty (30) CE hours required for renewal.

A.R.S. 32-1979.03(B)

Pharmacists who dispense self administered hormonal contraceptives under a standing prescription order: CE related to selfadministered hormonal contraceptives.

At least three (3) of the thirty (30) CE hours required for renewal.

A.R.S. 32-1979.01 R4-23-204 R4-23-407.2

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NEWS BOARD OF PHARMACY PHARMACY TECHNICIANS 20 total CE hours are required for renewal: DESCRIPTION

NUMBER

STATUTE/RULE

Opioid-related, substance use disorder-related, or addiction related continuing education activities.

Three (3) of the twenty (20) CE hours required for renewal.

A.R.S. 32-3248.02

*Remote Dispensing Pharmacy Technicians: CE in remote dispensing site pharmacy practices.

Two (2) hours - these hours are in addition to the twenty (20) total CE hours required for renewal.

This does not apply to pharmacy technicians who work from home.

A.R.S. 32-1923.01(C)(1)

Verification Technician: CE in patient safety.

Four (4) of the twenty (20) CE hours required for renewal.

A.A.C. R4-23-1104.01(D)(4)

*Note: Remote Dispensing Pharmacy is also known as “Telepharmacy”.

A remote dispensing pharmacy technician is a pharmacy technician who works in a remote pharmacy in accordance with A.R.S. 32- 1961.01. A remote pharmacy is supervised by a pharmacist remotely while the pharmacy technician works independently at the remote pharmacy. A remote pharmacy is physically staffed by pharmacy technicians while the pharmacist supervises remotely from another location. This does not apply to pharmacy technicians who work from home.

UPCOMING MEETINGS MEETING

DATE

Complaint Review

October 10, 2023

Board Meeting

October 18-19, 2023

Complaint Review

November 28, 2023

Board Meeting

December 6-7, 2023

Mailing Address: P.O. Box 18520 Phoenix, AZ 85005 Physical Address: 1110 W. Washington St., Suite 260 Phoenix, AZ 85007

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EDITORIAL BOARD OF PHARMACY

Arizona State Board of Pharmacy Sides with AzPA & Independent Pharmacy Coalition Rescinds June 2023 Vote on the Enforcement of November 1, 2023, Compendial Publication of USP General Chapters ‹795›, ‹797›, and ‹800›. Assigns Task Force to Evaluate Phoenix, AZ — “If 90 percent of the compounding pharmacies decide not to compound anymore, close their doors, Arizona citizens will suffer,” said Boesen & Snow Partner and Co-founder Mark Boesen while speaking before the Arizona State Board of Pharmacy on August 16, 2023, about the ramifications of the Board adopting future United States Pharmacopeia General Chapters ‹795›, ‹797›, and ‹800›. Representing the Arizona Pharmacy Association and the Arizona Independent Pharmacy Coalition, he explained these compounded medications are drugs of last resort for patients who use them. By motion after hearing from Mr. Boesen as well as Boesen & Snow Senior Attorney Michael Raine, the Board voted to rescind its prior order to adopt and enforce the chapters on November 1, 2023, and will now have its task force further evaluate the issue.

Mr. Boesen explained to the Board that when the USP publishes Chapters ‹795›, ‹797›, and ‹800› on November 1, 2023, it is not obligated to adopt the chapters. Mr. Boesen told the Board that it is not “hamstrung by Arizona or Federal law.”

Boesen & Snow Senior Attorney Michael Raine explained to the Board that state law does not allow the Board to incorporate by reference the USP and all its future amendments. Mr. Raine asked that the Board get engaged in discussion with the compounding community.

Mr. Boesen talked about how other states are addressing USP ‹800› and explained that so far only a minority have adopted it, and that many are presumably not expressing intent to adopt because it is too onerous, and the states are worried about access to compounded medication. He explained that many of the compounding pharmacies in Arizona are small and that it would be difficult for the pharmacies to comply with these USP chapters.

“I am not here to tell pharmacies that they ought not to do it, but I am here to say that there may be pharmacies that are engaged in low-risk activities that this board would be comfortable considering a different level of care,” Mr. Boesen explained.

Mr. Boesen emphasized that a one size fits all policy does not work, “why do we have to treat all of the drugs exactly the same” and that it should instead be based on the risk of the physical properties of the drug, level of danger, risk with exposure, as well as batch size. He said that there is a lack of science behind the USP process quoting industry expert Loyd Allen who stated, “My view of the revised Chapters 795 and 797 is that they are generally not scientifically supported by any evidence, but rather by opinions and what some individuals think ‘should be done.’” (Letter from L. Allen to USP Appeals Panel, Jan. 21, 2020)

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