Spring 2024 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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S P R I N G

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In This Edition:

The Drug Supply Chain Security Act

Not Just a Pediatric Illness: Updates on Respiratory Syncytial Virus (RSV) Prevention

Continuous Glucose Monitor (CGM) Billing and Supply Allowance

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. 6

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 Co-Editor Cindy Esquer 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 15 University & Alumni News 30 Editorial Annual Convention 6 Preceptors Corner 16 The Drug Supply Chain Security Act 19 Continuous Glucose Monitor (CGM) Billing and Supply Allowance 36 Advocacy Pharmacy Day at the Capitol 38 Continuing Education Not Just a Pediatric Illness: Updates on Respiratory Syncytial Virus (RSV) Prevention 21

UPCOMING EVENTS

April 20, 2024 | Virtual

April 20, 2024 | Glendale

June 6, 2024 | Phoenix, AZ

June 6, 2024 | Phoenix, AZ

June 6, 2024 | Phoenix, AZ

June 6-9, 2024 | Phoenix, AZ 3

EDITORIAL PRESIDENT'S MESSAGE Dear AzPA Members, Spring is here and I find myself reflecting on the recent encounters, challenges, and triumphs within the pharmacy profession. It is a time of both excitement and concern, as we navigate the ever-evolving landscape of healthcare and pharmacy practice.

CAPT Kimberly “Kim” Langley, PharmD, MBA, BCPS, FAzPA

One of the highlights of this season was undoubtedly the AzPA Spring Clinical Conference. Pharmacy professionals from across Arizona as well as out of state converged to share knowledge, expertise, and insights at this yearly conference. This gathering of dedicated and passionate pharmacy professionals filled me with pride and optimism for the future of our profession as I witnessed interprofessional collaboration and a sense of community among our healthcare colleagues from other professional organizations. This conference served as a reminder of the crucial role pharmacists play in team-based healthcare delivery that improves patient outcomes.

CAPT Kimberly Langley 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. CAPT 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

However, amidst the camaraderie and exchange of ideas, recent statements from the American Medical Association (AMA) regarding pharmacist training have left many of us disheartened. The assertion that pharmacists lack the necessary training to provide certain healthcare services undermines the years of education, training, and experience that pharmacists bring to their practice. It is imperative that we stand united in advocating for the value of pharmacist-led care and dispel misconceptions about our capabilities. Education and collaboration remain key in fostering mutual respect and understanding among healthcare professionals.

completed previous USPHS assignments at multiple duty stations across New Mexico and Arizona with Indian Health Service. During this time, CAPT Langley served in several diverse leadership positions including Pharmacy Manager, PGY-1 Residency Program Director, Cardiovascular Clinic Director, and IHS AgencyRepresentative to the Million Hearts Initiative. In 2015, CAPT Langley served as the Chief Pharmacy Officer for her team in Liberia as a part

Advancements in healthcare technology provides significant opportunities for improved patient care and efficiency. However, it also exposes us to new vulnerabilities, with sensitive patient data at risk of exploitation by malicious actors. The recent cyberattack on Change Healthcare serves as a wakeup call for investing in robust cybersecurity measures and staying abreast of emerging threats to minimize risk and ensure the trust of our patients. As guardians of patient health information, pharmacy professionals have a role in safeguarding our patient’s data and privacy.

of the Ebola crisis response in West Africa.

CAPT 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

Despite these challenges for the profession, I am filled with excitement and anticipation for the upcoming AzPA Annual Convention. This event promises to be a culmination of learning, networking, and celebration of our profession's achievements. I look forward to seeing you in Phoenix!.

Business Administration from The Citadel; and completed a Certificate in Business Process Management from Villanova University. She is also board-certified in Pharmacotherapy and served on multiple technical expert panels for Pharmacy

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

Quality Alliance for the development of cardiovascular and diabetes quality measures.

CAPT Langley is actively engaged in AzPA activities including serving on the Board of Directors as President, Director-at-Large, APhA House of Delegates Representative, member on several committees, faculty for 2 certificate programs, abstract peer reviewer, and conference speaker. In 2023, she was recognized as a fellow of the Arizona Pharmacy Association. Her leadership experience extends to various roles on multiple USPHS committees, workgroups, and mentoring programs.

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WELCOME NEW MEMBERS! 2nd Year Practitioner Alexis O’Neill Jessica Severin

Pharmacist Roseanna Borst Monique Dall Agnol Michonne Dietrich David Gurule Elizabeth Holmgren Yvonne Huckleberry Tincy Maroor Bradley Nash Yolimar Perez John Robinson Kerry Rodriguez Edward Spark

Resident Tara Bunni Adrian Chavez Serrato Michael Constant Jules Fuentebella Brian Gange J'kiya Jackson Allyson Prichard Josalynn Rightnour Florencio Robles

Retired Shelly Swalley

Technician Jenna Dalina Jeremy Gwizdalski Derek Jordan Maxwell Kukowski Benjamin Romero Harriett Samaroo Cassie Watson

AZPA NEWS

Student Pharmacist Jesse Abah Haneen Alkaylanie Cheleen An Mona Bayat Lorin Deese Keval Desai Ejemen Eichie Jaime Elliott-Shields Maha Elrakaiby Halie Erwin Erica Therese Esteban Juliette Feigal Candice Flinner Spencer Hemmingsen Thomasine James Rxyl Jade Jinon Ramandeep Kaur Heleen Khan Amit Lakha Jenny Le Paola Lugo Rania Mamo Andrew Marcelo Ali Mohsin Masha Mosavi Michelle Nguyen Minh Nguyen Kyra OkinAyushi Patel Uprami Patel-Dimitrijevic Megan Paul Stormi Rich Keri Scheidt Aya Tayeb Loreto Tena Gutierrez Taylor Tokach Alina Torres Vanessa Virgen Noelle Walton Mona Zegar

Associate Marc Crouch Davin Deb Erin Fry

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EDITORIAL ANNUAL CONVENTION

Thursday, June 6 8:00AM - 5:00PM | SOUTHWESTERN STATES RESIDENCY CONFERENCE

(Separate registration and fee) 8:00AM - 5:00PM | AzPA ANTICOAGULATION CERTIFICATE TRAINING PROGRAM

(Separate registration and fee)

8:00AM - 9:00AM | BREAKOUT SESSION 2: LIFESTYLE MEDICINE

Elizabeth Pogge, PharmD, MPH, BCPS, FASCP, FAzPA;

(LM) IN PHARMACY PRACTICE: WHAT IS LM ALL ABOUT AND

Lindsay Davis, PharmD, BCPS, BCCP, ASH-CHC, TTS, FAzPA,

HOW CAN PHARMACISTS BE PREPARED TO ENGAGE IN A

FCCP; Kelly Erdos, PharmD, BCACP, CACP; Elisabeth Palmer,

RAPIDLY GROWING AND EFFECTIVE DISCIPLINE

PharmD

Edward Stein, PharmD, MPH, DipACLM; Jane E. Stein, PharmD

8:00AM - 12:00PM | APhA’s THE PHARMACIST & PATIENT-

1. Describe Lifestyle Medicine (LM) and the Six Pillars for lifestyle.

CENTERED DIABETES CARE CERTIFICATE TRAINING PROGRAM

2. Discuss differences between Lifestyle Medicine and Integrative

Learning Objectives for Pharmacists and Technicians:

(Separate registration and fee)

and Functional Medicine and appropriate applications as a

CAPT Kimberly Langley, PharmD, MBA, BCPS; Anthony Albert,

foundation for conventional health care practice.

PharmD, BC-ADM, BCACP

3. Identify three major challenges or barriers to integrating Lifestyle Medicine interventions in an interprofessional practice setting.

12:00PM - 1:00PM | NON-ACCREDITED SYMPOSIUM

4. Identify areas within the continuum of pharmacy education curricula (from undergraduate, to pharmacy school, to post-

5:30PM - 7:00PM | AZPA BOARD OF DIRECTORS MEETING

graduate residency training and beyond) in which to integrate

Open to all attendees

Lifestyle Medicine learning to prepare pharmacists to engage in these evidence-proven health interventions.

7:30PM - 8:30PM | WELCOME RECEPTION

Open to All Attendees

9:10AM - 10:10AM | BREAKOUT SESSION 1: INK & INSIGHTS: MEDICAL WRITING FOR PHARMACY PROFESSIONALS

Friday, June 7 6:00AM - 5:00PM | REGISTRATION

Kathleen Fairman, PhD, MA; Elizabeth Pogge, PharmD, MPH, BCGP, BCPS, FASCP, FAzPA Learning Objectives for Pharmacists and Technicians: 1. Identify topics that may be appropriate for publication.

7:00AM - 7:45AM | COFFEE & NETWORKING ROUNDTABLES: Topics to be determined.

2. Describe how to implement clinical research into the pharmacy professional's practice.

3. Summarize existing research information efficiently to maximize

7:45AM - 8:00AM | WELCOME, OVERVIEW OF CONVENTION, AND CE CLAIM PROCESS

Kelly Fine, RPh, FAzPA & Dawn Gerber, PharmD, BCGP, FASCP,

the value of the pharmacy professional's work.

4. Work effectively with peer reviewer comments to produce a publishable article.

FAzPA 8:00AM - 9:00AM |BREAKOUT SESSION 1: ANTIOBESITY MEDICINES (AOMS): PATIENT-CENTRIC BEST PRACTICES

Kelsey Leite, PharmD Learning Objectives for Pharmacists: 1. Identify patient populations for whom AOMs may be suitable.

2. Develop strategies to mitigate potential risks associated with AOMs. 3. Describe potential barriers to adherence and compliance with AOMs.

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EDITORIAL ANNUAL CONVENTION 9:10AM - 10:10AM | BREAKOUT SESSION 2: HIV AND AGING:

10:20AM - 11:20AM | BREAKOUT SESSION 3: A HISTORICAL

FOCUS ON CARDIOVASCULAR RISK REDUCTION

EXPLORATION OF VETERINARY COMPOUNDING PHARMACY

Cassandra Anderson, PharmD, MS, BCGP, CSP, AAHIVP, CAPM

REGULATION IN THE UNITED STATES

Learning Objectives for Pharmacists:

Michael Blaire, RPh

1. Identify current numbers and trends for HIV infection in the geriatric population in the United States.

2. Describe how HIV contributes to cardiovascular disease risk.

3. Discuss current treatment regimens for CVD risk reduction and their safety and effectiveness profiles in people living with HIV. 4. List population-specific factors to target for CVD risk reduction in people living with HIV.

Learning Objectives for Pharmacists and Technicians: 1. List key legislation for veterinary compounding pharmacy in the United States.

2. Identify key legislation's implications for veterinary compounding pharmacy in the United States.

3. Describe the evolution of compounding standards and guidelines specific to veterinary pharmacy practice, recognizing their impact on ensuring the safety and efficacy of compounded medications.

10:20AM - 11:20AM | BREAKOUT SESSION 1: HEPATITIS C-YA

4. Describe case studies illustrating notable events that have

LATER- GUIDANCE ON SCREENING AND CURATIVE TREATMENT

influenced regulatory decisions and shaped the landscape of

OPTIONS FOR HEPATITIS C

veterinary compounding pharmacy.

Josalynn Rightnour, PharmD; Jacob Northrup, PharmD, BC-ADM, CDCES Learning Objectives for Pharmacists: 1. Identify eligible patients for HCV Screening.

2. List appropriate lab work for initial HCV screening.

3. Summarize pangenotypic treatment options’ counseling points.

10:20AM - 11:20AM | BREAKOUT SESSION 2:THE MONOCLONAL

Register Today!

MOSAIC: NAVIGATING ALZHEIMER'S TREATMENT FRONTIERS

Andrea Callas, PharmD; Dawn Gerber, PharmD, BCGP, FASCP, FAzPA Learning Objectives for Pharmacists: 1. Discuss anti-amyloid-β monoclonal antibodies' FDA approval process history.

2. Compare anti-amyloid-β monoclonal antibodies' and cholinesterase inhibitors' mechanism of actions.

3. Contrast anti-amyloid-β monoclonal antibodies' and cholinesterase inhibitors' adverse effect profiles.

Accreditation Information The Arizona Pharmacy Association is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education (CPE).

Continuing Education Sessions approved for CE credits are indicated by the CE icon, an ACPE number, and the number of CEUs in the session listing.

To obtain CPE credit for any of the LIVE sessions, learners must attend the session live, enter the session code, and complete the assessment quiz and evaluation for each session attended. The session code and further instructions will be provided at the end of each LIVE session.

Learning Level: Varies Activity Type: Knowledge and Application-based Target Audience: Pharmacists and Technicians Disclosures Disclosures will be announced at the beginning of each session and can be found in the Event Program under each speaker(s) biography. AzPA CE staff declare no conflicts of interest or financial interests in any product or service mentioned in this activity. View Disclosures. Conflicts of interest have been resolved through content review by the AzPA CE Committee Department and Committee.

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EDITORIAL ANNUAL CONVENTION 11:30AM - 12:30PM | NON-ACCREDITED SYMPOSIUM

1:50PM - 2:50PM | BREAKOUT SESSION 1: THREATS AND OPPORTUNITIES: A COMPOUNDING PUBLIC POLICY UPDATE

12:40PM - 1:40PM | BREAKOUT SESSION 1: HOW DID MY

Tenille Davis, PharmD, RPh, BCSCP, FACP

TUESDAY CHANGE? THE CRUCIAL ROLE OF ACTIVE POLITICAL

Learning Objectives for Pharmacists and Technicians:

INVOLVEMENT IN SAFEGUARDING YOUR PHARMACY

1. Evaluate how proposed regulation that affects the practice of

PROFESSION

compounding should be assessed.

Mark Boesen, PharmD, JD, FAzPA

2. Describe Pharmacy Compounding's Regulatory Framework.

Learning Objectives for Pharmacists & Technicians:

3. Identify some regulatory challenges that compounding pharmacists

1. Develop effective strategies for engaging in political advocacy.

face from the state and federal level.

2. Define the key principles and concepts of political advocacy.

This session is underwritten by a grant from the Pharmacy

3. Apply ethical considerations in political advocacy efforts within the

Compounding Foundation.

pharmacy profession.

1:50PM - 2:50PM | BREAKOUT SESSION 2: DIABETES REGIMEN 12:40PM - 1:40PM | BREAKOUT SESSION 2: HEY SUGAR SUGAR

PERSONALIZATION AND INTRA-CLASS MEDICATION

Samantha Zimmerman, PharmD, MLS, BS; Jacob Northrup, PharmD,

SELECTION

BC-ADM, CDCES, Leah Rios, PharmD Candidate

Anthony Albert, PharmD, BCACP, BC-ADM

Learning Objectives for Pharmacists:

Learning Objectives for Pharmacists:

1. Identify updates to the 2024 American Diabetes Association (ADA)

1. Apply pharmacotherapy guidelines for diabetes (ADA,AACE) to a

Standards of Care in Diabetes guidelines.

2. Choose an appropriate Continuous Glucose Monitoring (CGM) device based on patient preferences.

3. Compare CGM device characteristics for various patient populations.

patient case.

2. Contrast agents within the same class with respect to safety, effectiveness, pharmacokinetics, and pharmacodynamics.

3. Design a diabetes medication regimen with respect to patient characteristics.

Learning Objectives for Technicians: 1. Summarize Continuous Glucose Monitoring (CGM) device and insulin pump options for patients with diabetes.

2. Identify necessary components of Continuous Glucose Monitoring (CGM) device and insulin pump dispensing.

1:50PM - 2:50PM | BREAKOUT SESSION 3: EMBRACING RESILIENCE: A PERSONAL JOURNEY THROUGH ADDICTION AND LIFELONG SOBRIETY IN A PROFESSIONAL SETTING

Ryan Gries, PharmD, BCPS, BC-ADM Learning Objectives for Pharmacists & Technicians:

12:40PM - 1:40PM | BREAKOUT SESSION 3: TRANSITION

1. Develop a deeper understanding of the challenges faced by

CONSIDERATIONS FOR PROVIDERS, PAYORS, AND PATIENTS IN

individuals with addiction by actively listening to the personal story

THE EMERGENCE OF BIOSIMILARS

of addiction and recovery shared by the pharmacy professional.

Alexis Smith, PharmD; Hannah Henderson, PharmD; Lillianne Do,

2. Identify key factors and triggers that contribute to addiction.

PharmD, BS; Pilar Gaggin, PharmD, CSP, AAHIVE

3. Recognize signs of potential addiction in patients in a pharmacy

Learning Objectives for Pharmacists: 1. Define biologics and biosimilars.

2. Identify interchangeable adalimumab.

setting.

4. Explore strategies for providing empathetic and non-judgmental support to individuals on their journey to recovery.

3. Discuss the differences between each adalimumab biosimilar including indications/dosing, side effects, efficacy, and cost.

4. Describe the advantages of using an adalimumab biosimilar over the reference product.

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EDITORIAL ANNUAL CONVENTION 3:00PM - 4:00PM | GENERAL SESSION: PURDUE PHARMA

3:10PM - 4:10PM | BREAKOUT SESSION 3: THE NEW

SUPREME COURT DECISION: UNRAVELING PAST, PRESENT, AND

PRESCRIPTION DRUG LAW; INFLATION REDUCTION ACT

FUTURE IMPLICATIONS IN HEALTHCARE AND JUSTICE

Eman Kirolos, PharmD, MS, DASPL

Mark Boesen, PharmD, JD, FAzPA

Learning Objectives for Pharmacists and Technicians:

Learning Objectives for Pharmacists and Technicians:

1. Identify the major milestones of the Inflation Reduction Act

1. Describe the December 2023 Purdue Pharma Supreme Court decision.

2. Describe the historical timeline leading to the December 2023 Purdue Pharma Supreme Court decision.

3. Examine the implications of the December 2023 Purdue Pharma

implementation.

2. Differentiate Part-B and Part-D insulin and vaccine coverage.

3. Describe how the new prescription drug law helps millions of Medicare beneficiaries.

4. List valuable resources to be shared with Medicare beneficiaries.

Supreme Court decision.

5:15PM - 7:00PM | EXHIBIT HALL: WELCOME RECEPTION 4:10PM - 5:10PM | BREAKOUT SESSION 1: PRECEPTOR

Support our Convention Sponsors and Exhibitors while you mingle

WORKSHOP: CHOOSE YOUR OWN ADVENTURE

and enjoy appetizers!

Janet Cooley, PharmD, BCACP; Suzanne Larson, PharmD Learning Objectives for Pharmacists:

7:00PM - 8:00PM | FRIENDS & ALUMNI MIDWESTERN

1. Compare and contract different approaches to precepting situations

UNIVERSITY RECEPTION

(e.g. student orientation, feedback, wellness).

Invitation Only

2. Modify approach to precepting and student concerns based on evidence regarding precep.

8:00PM - 10:00PM | ENTERTAINMENT NIGHT: NAME THAT TUNE

3. Recommend a plan to incorporate precepting practices back into their practice sites.

3:10PM - 4:10PM | BREAKOUT SESSION 2: HELLO INSULIN, MY

Saturday, June 8

OLD FRIEND,CATCHING UP ON NEW FORMULATIONS WITH

6:00AM - 5:00PM | REGISTRATION

REAL-WORD APPLICATION

Lisa Beckett, PharmD, BCACP, CDCES, AAHIVP; Sara Shahdoost

7:00AM - 7:45AM | NON-ACCREDITED SYMPOSIUM

Moghadam, PharmD, BCACP, CDCES, AAHIVP Learning Objectives for Pharmacists:

7:00AM - 5:00PM | STUDENT LEADERSHIP & LEGACY TRACK*

1. Review the implications of new insulin products on patient care.

2. Review legal landscape around biosimilar and interchangeable

7:00AM - 5:00PM | TECHNICIAN TRACK*

biosimilars with specific applications to insulin products.

3. Describe when a new insulin product may be preferred.

7:45AM - 8:00AM | WELCOME, OVERVIEW OF CONVENTION,

4. Describe how to perform insulin dose conversions.

AND CE CLAIM PROCESS

5. Summarize anticipated next developments in the insulin therapy

Kelly Fine, RPh, FAzPA & Dawn Gerber, PharmD, BCGP, FASCP,

landscape with a focus on once weekly insulin(s).

FAzPA

Learning Objectives for Technicians: 1. Identify brand and generic names of new insulin products.

2. Explain Arizona state rules for substitution with interchangeable biosimilar insulin(s).

3. Discuss upcoming advances in insulin therapy such as once weekly insulin.

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EDITORIAL ANNUAL CONVENTION 8:00AM - 9:00AM | GENERAL SESSION: PHARMACY BOWL

Moderator: Jacob Schwarz, PharmD, MBA, BCIDP, BCCCP, BCPS, FAzPA Learning Objectives for Pharmacists & Technicians: 1. Recall the brand or generic name of medications.

2. Perform pharmacy calculations needed in different practice settings.

9:15AM - 10:15AM | BREAKOUT SESSION 1: UNMASKING IMPOSTER SYNDROME: HOW TO CONVINCE YOUR INNER FRAUD YOU'RE THE REAL DEAL!

Bianca Glab, PharmD, MC, RPh; Jacob Northrup, PharmD, BC-ADM, CDCES Learning objectives for Pharmacists & Technicians: 1. Define imposter syndrome (IS).

2. List the subtypes of imposters.

3. Discuss effective strategies to recognize imposter syndrome.

4. Discuss effective strategies to manage imposter syndrome.

9:15AM - 10:15AM | BREAKOUT SESSION 2: GOLDEN INSIGHTS: NAVIGATING CHRONIC OBSTRUCTIVE PULMONARY DISEASE GUIDELINES

Courtney Coombe, PharmD, CDCES; Adrienne Waibel, PharmD, CDCES Learning Objectives for Pharmacists: 1. List the most up to date recommendations for management of COPD per GOLD 2024 Guidelines.

2. List the most up to date recommendations for management of COPD exacerbations per GOLD 2024 Guidelines.

3. Describe the recommended vaccine schedule in COPD patients.

9:15AM - 10:15AM | BREAKOUT SESSION 3: ANTIMICROBIAL STEWARDSHIP UPDATES ACROSS THE ARIZONA HEALTHCARE SPECTRUM

Tho Pham, PharmD, BCIDP; Vanthida Huang, BSPHM, PharmD Learning Objectives for Pharmacists: 1. Discuss important updates on the CDC Priority Core Elements of Hospital Antibiotic Stewardship Programs.

2. List stewardship updates from the Arizona Department of Health Services.

3. Review the CDC Core Elements of Antibiotic Stewardship for Nursing Homes.

4. Review stewardship updates from Arizona Department of Health

10:30AM - 12:00PM | BREAKOUT SESSION 1: BIOSTATS 101: BASIC PRINCIPLES AND EVALUATION OF STUDIES

Jacob Schwarz, PharmD, MBA, BCIDP, BCCCP, BCPS, FAzPA Learning Objectives for Pharmacists: 1. Differentiate between types of data (nominal, ordinal, interval/ratio), measures of central tendency, and appropriate statistical tests.

2. Interpret hypothesis testing, p values, confidence intervals, odds and risk ratios, and both statistical and clinical significance.

3. Define the absolute risk, relative risk, number needed to treat given data from a study.

4. Calculate the absolute risk, relative risk, number needed to treat given data from a study.

5. Review the hierarchy of evidence and discuss both the advantages and disadvantages of various study designs.

10:30AM - 12:00PM | BREAKOUT SESSION 2: TRENDS IN HORMONAL CONTRACEPTION

Erin Raney, PharmD, BCPS, BC-ADM, FCCP; Shareen El-Ibiary, PharmD, BCPS, FCCP, FAzPA Learning Objectives for Pharmacists: 1. Compare and contrast recently approved hormonal contraceptives.

2. Choose individualized hormonal contraceptive regimens based upon a statewide standing order for pharmacists.

3. Summarize the recommendations for the new nonprescription progestin-only contraceptive.

10:30AM - 11:30AM | BREAKOUT SESSION 3: CANDIDA AURIS: THE PATHWAY OF YEAST RESISTANCE

Scott Volker, PharmD; Vanthida Huang, BSPHM, PharmD Learning Objectives: 1. Discuss the key principles in the management of C. auris infection.

2. Identify infection prevention and control measures for C. auris transmission and outbreaks.

3. Describe the epidemiology and transmission of C.auris as an emerging pathogen.

4. Describe the transmission of C.auris as an emerging pathogen.

12:15PM - 2:00PM | EXHIBIT HALL | RECEPTION Support our Convention Sponsors and Exhibitors while you mingle and enjoy lunch.

Services.

5. Describe CDC Core Elements of Outpatient Antibiotic Stewardship, including outpatient and dental healthcare settings.

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EDITORIAL ANNUAL CONVENTION 2:15PM - 3:15PM | KEYNOTE GENERAL SESSION: CONNECTING

3:30PM - 4:30PM | BREAKOUT SESSION 3: TO EXTEND OR NOT

TO YOUR PASSION FOR PHARMACY AFTER BURNOUT

TO EXTEND: PROLONGED INFUSION BETA-LACTAMS

Jerrica Dodd, PharmD

Kaylee Whitenack, PharmD; Jacob Schwarz, PharmD, MBA, BCIDP, BCCCP, BCPS, FAzPA

3:30PM - 5:00PM | BREAKOUT SESSION 1: IMMUNIZATION

Learning Objectives for Pharmacists:

UPDATE

1. Summarize the current state of practice regarding extended-

CAPT Holly Van Lew, PharmD, BCPS, AAHIVP; Sophia Galloway, PharmD, BCACP, FAzPA Learning Objectives for Pharmacists: 1. Discuss recent updated indications and expanded age ranges for routine vaccinations, including pneumococcal, RSV, and

infusion beta.

2. Evaluate the evidence supporting the use of extended-infusion beta.

3. Identify the appropriate clinical scenarios to employ an extended infusion.

meningococcal.

2. Apply the current recommendations for routine vaccinations.

5:00PM - 5:45PM | PAST PRESIDENT'S RECEPTION

3. Assess current immunization practices for their practice site.

-Invitation Only-

4. Determine implementation strategies for expanding vaccination efforts.

5. Discuss vaccine administration best practices, including injection technique and updated injection routes for certain live vaccines.

7:00PM - 9:00PM | 2024 ANNUAL AWARDS PRESENTATION Join us for a celebration of AzPA’s prestigious 2024 awardees. This evening is a not-to-be-missed event!

Learning Objectives for Technicians: 1. Describe tools and resources available for immunization schedules and recommendations.

2. Utilize the 2024 Adult & Pediatric Immunization Schedules to select

Sunday, June 9 6:00AM - 1:00PM | REGISTRATION

the correct dose and route of administration.

3. Determine ways to support increased vaccine administration.

7:00AM - 8:00AM | NON-ACCREDITED SYMPOSIUM -

4. Describe ways to improve workflow support vaccinations.

BREAKFAST

5. Discuss vaccine administration best practices, including injection technique and updated injection routes for certain live vaccines.

7:00AM - 7:50AM | HEADING TOWARDS OUR FUTURE: AZPA TOWN HALL

3:30PM - 4:30PM | BREAKOUT SESSION 2: SPECIAL OLYMPICS

Jacob Schwarz, PharmD, MBA, BCIDP, BCCCP, BCPS, FAzPA;

ARIZONA INCLUSIVE HEALTH PROGRAMS

CAPT Kimberly Langley, PharmD, MBA, BCPS; Dawn Gerber,

Ashkan Rastegar, PharmD Candidate 2024, Erin Raney, PharmD,

PharmD, BCGP, FASCP, FAzPA; Kelly Fine, RPh, FAzPA

BCPS, BC-ADM, FCCP

Learning Objectives for Pharmacists & Technicians:

Learning Objectives for Pharmacists & Technicians:

1. Describe the key components of the new strategic plan for AzPA.

1. Describe the structure of the SOAZ, including its mission, goals, and

2. Discuss the implications of the new strategic plan for AzPA and its

key functions.

2. Identify opportunities for pharmacy professionals within the SOAZ.

stakeholders.

3. Discuss the practical implementation of the new strategic plan.

3. Discuss the practical applications of pharmacy professionals' experiences and perspectives within the context of the SOAZ.

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EDITORIAL ANNUAL CONVENTION 8:00AM - 9:00AM | BREAKOUT SESSION 1: THE PHARMACIST'S

9:10AM - 10:10AM | BREAKOUT SESSION 1: DIVERSION WITHIN

ROLE IN MANAGING ANXIETY, INSOMNIA, AND DEPRESSION IN

THE PHARMACY; WHAT CAN I DO?

OLDER ADULTS

Kristen Snair, CPhT, MSJ; Sabrina Hernandez, CPhT

Martha Fankhauser, BS (Pharmacy), MS (Pharmacy), BCPP, FASHP,

Learning Objectives for Pharmacists and Technicians:

FAzPA

1. Identify red flags that are cause for a level of awareness for

Learning Objectives for Pharmacists: 1. Identify risk factors for mental health conditions in later life.

2. Describe treatment options for anxiety, insomnia, and depression in older adults.

3. List prevention strategies for older adults that focus on healthy aging.

potential diversion.

2. Discuss strategies that can be deployed to mitigate diversion from pharmacy staff.

3. List and create an awareness of what can and should be done if pharmacy staff diversion is suspected along with potential consequences of non-compliance.

4. Recommend how clinicians can recognize, assess, treat, and monitor mental health disorders in older adults.

9:10AM - 10:10AM | BREAKOUT SESSION 2: MENTORSHIP AND SPONSORSHIP- A PANEL PERSPECTIVE

8:00AM - 9:00AM | BREAKOUT SESSION 2: NAVIGATING

Brought to you bythe AzPA MCP Committee

GENERATIVE AI: RISKS, BENEFITS, AND PRACTICAL

Casey Orton, PharmD, MBA

APPLICATIONS

Learning Objectives for Pharmacists & Technicians:

Ryan Gries, PharmD, BCPS, BC-ADM; Dawn Gerber, PharmD, BCGP,

1. Describe the difference between mentorship and sponsorship.

FASCP, FAzPA

2. List the benefits of mentorship.

Learning Objectives for Pharmacists & Technicians:

3. Summarize the outcomes of sponsorship.

1. List the types of generative artificial intelligence.

4. Discuss methods to sponsor talent in workplace and professional

2. Articulate the potential uses of generative artificial intelligence.

network settings.

3. Discuss the limitations of generative artificial intelligence.

4. Describe strategies for optimizing the use of generative.

10:20AM - 11:20AM | BREAKOUT SESSION 1: CARING BEYOND THE COUNTER: EMOTIONAL CHALLENGES IN THE OPIOID

8:00AM - 9:00AM | BREAKOUT SESSION 3: VALUE BASED CARE:

CRISIS

WHAT PROVIDERS WISH PHARMACISTS KNEW

Jimmy Stevens, PharmD

Cassandra Richardson, PharmD, BCACP, TTS; Adam S. Chesler,

Learning Objectives for Pharmacists & Technicians:

PharmD, MBA

1. Analyze the ethical dilemmas faced by the protagonist in "The

Learning Objectives for Pharmacists and Technicians: 1. Describe a brief history of Medicare and value-based care (VBC).

2. Define of VBC terminology.

3. List real-life examples of VBC. 4. Explain the measures and metrics used to evaluate

Pharmacist."

2. Explore the impact of opioid crisis portrayed in "The Pharmacist" on communities and healthcare systems.

3. Discuss the emotional toll on healthcare providers dealing with societal challenges.

physicians/advanced practice practitioners (APPs).

5. Explain the areas of overlap between pharmacists and

10:20AM - 11:20AM | BREAKOUT SESSION 2: TAKING THE LEAP:

physicians/Advanced Practice Providers (APPs) concerning

NAVIGATING CAREER TRANSITIONS IN PHARMACY

Healthcare Effectiveness Data and Information Set (HEDIS), Star

Brought to you by the AzPA Education Committee

Ratings (STAR), Consumer Assessment of Healthcare Providers

Ariane Guthrie, PharmD, BCGP, BCPS

and Systems (CAHPS), and various other Value-Based Care (VBC)

Learning Objectives for Pharmacists & Technicians:

measurement metrics.

1. Discuss the landscape of pharmacy and workforce projections.

2. Identify sources of job dissatisfaction and burnout among pharmacy professionals.

3. Identify resources to assist with career transitions within pharmacy.

12

EDITORIAL ANNUAL CONVENTION 10:20AM - 11:20AM | BREAKOUT SESSION 3: BREAKING

9:15AM - 10:15AM | BREAKOUT SESSION: UNMASKING

BARRIERS: ENHANCING PREP ACCESS AND ADHERENCE IN

IMPOSTER SYNDROME: HOW TO CONVINCE YOUR INNER

UNDERSERVED POPULATIONS

FRAUD YOU'RE THE REAL DEAL!

Yousef Toma, PharmD, BCPS, CSP, AAHIVP

Bianca Glab, PharmD, MC; Jacob Northrup, PharmD, BC-ADM,

Learning Objectives for Pharmacists:

CDCES

1. Identify communities at increased risk of HIV transmission who also

Learning Objectives for Pharmacists & Technicians:

experience disparities in accessing PrEP. 2. Describe the influence of social determinants of health and healthcare barriers on the uptake of PrEP. 3. Identify trends in PrEP use and persistence among different

1. Define imposter syndrome (IS).

2. List the subtypes of imposters.

3. Discuss effective strategies to recognize imposter syndrome.

4. Discuss effective strategies to manage imposter syndrome.

populations.

4. Identify effective strategies for healthcare professionals to enhance PrEP within vulnerable populations.

10:30AM - 11:30AM | ARTICULATING LEADERSHIP PROFICIENCY IN THE 'TELL ME ABOUT YOURSELF' MOMENT

Jeremy Gerber, PharmD, MBA, BCPS, BCOP, CNSC 11:30AM - 12:30PM | GENERAL SESSION: 2024 PHARMACY LAW

Learning Objectives for Pharmacists & Technicians:

UPDATE

1. List common pitfalls and challenges related to incorporating

Kaitlyn Fydenkevez, JD; Alex Snyder, JD Learning Objectives for Pharmacists & Technicians: 1. Describe ramifications of recent pharmacy-related court cases.

2. List recent changes in Federal Pharmacy Law. 3. List recent changes in State Pharmacy Law.

leadership skills into introductory responses.

2. Describe strategies for overcoming common pitfalls and challenges related to incorporating leadership skills into introductory responses.

3. Apply strategies for overcoming common pitfalls and challenges related to incorporating leadership skills into introductory responses.

Technician Track - Saturday

12:15PM - 2:00PM | EXHIBIT HALL | LUNCH

Note: Technicians have an opportunity to attend any other CE session

Support our Convention Sponsors and Exhibitors while you mingle

accredited for technicians (UAN ends in T)

and enjoy lunch.

7:00AM - 7:50AM | COFFEE & NETWORKING ROUNDTABLE

2:15PM - 3:15PM | KEYNOTE GENERAL SESSION: CONNECTING

Melinda Browning, MSc, CPhT; Kristen Snair, CPhT, MSJ

TO YOUR PASSION FOR PHARMACY AFTER BURNOUT

Jerrica Dodd, PharmD 8:00AM - 9:00AM | PHARMACY BOWL

Moderator: Jacob Schwarz, PharmD, MBA, BCIDP, BCCCP, BCPS,

3:30PM - 4:30PM | CREATING A CULTURE OF POSITIVE

FAzPA

FEEDBACK AND RECOGNITION FOR PHARMACY TECHNICIANS

Learning Objectives for Pharmacists and Technicians:

Kristine Smith, B.S., CPhT-Adv, CSPT; Nick Ruiz, CPhT-Adv, CSPT,

1. Recall the brand or generic name of medications.

FAPC; Matthew Alvarado, CPhT, CSPT

2. Perform pharmacy calculations needed in different practice settings.

Learning Objectives for Pharmacists & Technicians: 1. List various feedback models.

2. Describe how to effectively give feedback.

3. Explain how feedback directly impacts engagement.

13

EDITORIAL ANNUAL CONVENTION

Student Track - Saturday 8:00AM - 9:00AM | ELEVATE YOUR RESIDENCY CANDIDACY: STRATEGIES TO SHINE IN THE PHARMACY RESIDENCY SELECTION

Yousef Toma, PharmD, BCPS, CSP, AAHIVP 9:15AM - 10:15AM | UNMASKING IMPOSTER SYNDROME: HOW TO CONVINCE YOUR INNER FRAUD YOU'RE THE REAL DEAL!

Bianca Glab, PharmD, MC, RPh; Jacob Northrup, PharmD, BCADM, CDCES Learning Objectives for Pharmacists & Technicians: 1. Define imposter syndrome (IS).

2. List the subtypes of imposters.

3. Discuss effective strategies to recognize imposter syndrome.

4. Discuss effective strategies to manage imposter syndrome.

10:30AM - 11:15AM | INTERVIEW TIPS AND TRICKS FOR STUDENTS

Dawn Gerber, PharmD, BCGP, FASCP, FAzPA

11:20AM-12:20PM | TAKING CARE OF YOU: LIFE AFTER SCHOOL

Liliane Mofor PharmD, MBA Learning Objectives for Pharmacists & Technicians: 1. Define financial literacy.

2. Identify challenges to providing care caused by financial stress.

3. List the components of a budget.

4. Assess your situation and be able to write 2-3 personal financial goals with action steps.

12:15PM - 2:00PM | EXHIBIT HALL | LUNCH Support our Convention Sponsors and Exhibitors while you mingle and enjoy lunch.

2:15PM - 3:15PM | KEYNOTE GENERAL SESSION: CONNECTING TO YOUR PASSION FOR PHARMACY AFTER BURNOUT

Jerrica Dodd, PharmD 3:30PM - 5:00PM | MOCK INTERVIEWS

Valerie Richards, PharmD

14

AzPA HEALTH SYSTEM SPECIAL INTEREST GROUP (AZ-ASHP)

AZ-ASHP AFFILIATE NEWS

Spring is in the air and this year is off to a great start! Time seems to fly by very quickly and 2030 is just around the corner. Why did I pick the year 2030 you ask…? Well, the ASHP Practice Advancement Initiative (PAI) 2030 has been on my mind. This work serves as an aspirational roadmap to pharmacy practice advancement with future-focused concepts that look beyond today’s barriers to change. PAI 2030 has 59 recommendations on providing optimal, safe, and effective medication use that fall into six themes for practice change.

• Optimize care via pharmacist-provided comprehensive medication management.

• Integrate pharmacy enterprise for convenient and cost-effective care.

• Harness data to improve patient health.

• Adopt personalized, targeted therapies.

• Increase public health opportunities in social determinants, chronic illness, and addiction.

• Advance pharmacy technician roles.

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

ASHP’s PAI 2030 is a forward-thinking initiative that envisions the future role of pharmacists in healthcare. By embracing innovation, prioritizing patient-centered care, and investing in professional development, ASHP aims to position pharmacists as integral members of the healthcare team in the years to come. If you would like to learn more about PAI 2030 you can find addition details at About PAI 2030 - ASHP. In the vein of practice advancement, we had a very successful Spring Clinical Conference in February, and we are now gearing up for the Annual Convention which will be held at the Hilton Phoenix Resort at The Peak on June 6 – 9, 2024. This is another great opportunity for getting CE as well as networking with colleagues and reuniting with friends.

As a reminder, the Health Systems Pharmacy SIG is actively recruiting new members.

If you are interested in getting involved, please sign up using the link below.

We meet monthly to discuss issues relevant to health systems pharmacists in Arizona. The more perspectives we have on this group, the more we can make sure AzPA is serving the needs of its health systems members. Hope to see you on the next call!

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

Learn More Here

15

EDITORIAL PRECEPTOR CORNER

"Sharing our failures with students can normalize the discussion about failure and demonstrate the concept that failure is oftentimes a catalyst for growth and the spark that can propel us towards success."

​We Don’t Talk About Failure...

No, No, No AUTHORS/CONTRIBUTORS Melinda J. Burnworth, PharmD, FASHP, FAzPA, BCPS, Professor 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.

16

CONT. PRECEPTOR CORNER Introduction

include poor rotation evaluations, rejected manuscripts, denial of

The 2021 Disney musical “Encanto” features a catchy

promotion or advancement, or not being selected for a job. Reflecting

song about a misunderstood and rarely discussed uncle, Bruno.1 The

on our own failures can help us recognize that failure can be an

chorus describing the family’s relationship to Bruno proclaims, “We don’t talk about Bruno, no, no, no.”1 The Madrigal family

important accelerator of the learning process and a step in

misunderstood Bruno’s gift of seeing the future, and instead thought

opposite ends of the same continuum. However, a more realistic and

Bruno’s visions were omens that caused uncomfortable or unfortunate events.1 This song highlights the human reflex of avoiding people,

accurate way to view failure is as a steppingstone on the road to

situations, and discussions that make us uncomfortable.1 In the end,

essential part of our own hero’s journey. Often, a failure can prompt

the Madrigal family comes to a healthier and more accurate conclusion

us to make necessary adjustments that are required for subsequent

about Bruno, confronted their erroneous perceptions, and embraced this family member, leading to a happy ending for the entire family.1

successes.

developing resilience. Oftentimes, failure and success seem like

success. In other words, we can remember that failures are an

Literature on Educational Failures The authors of this commentary have noticed a similar parallel to how

Literature is emerging on failure in pharmacy education. Regarding

educators and students can sometimes neglect discussing

professional development, Nohria and McBane thoughtfully address

the concept of failure in academic settings. We don’t talk about failure,

the need for educators to reflect on how their own failures can be

no, no, no. When educators speak to students about failure, these conversations often involve a box of tissues, intense emotions, and

seen as a step toward innovation with an appropriate mindset and support.4 Additionally, there are examples of educators intentionally

are hidden behind closed office doors. There may be an element of

building opportunities into pharmacy curricula to help equip students

shame and embarrassment. Neither student nor educator typically

to discuss and address different types of failures. Ragucci and Poirier

enjoys discussions about failure, and this important topic can be left neglected. This commentary builds on previous discussions initiated

both describe interprofessional error disclosure educational programming.5,6 Frenzel describes pharmacy educational

by Brazeau and DiPiro to normalize and destigmatize failures in an academic setting.2,3 The purpose of this commentary is to continue

simulations in which students apply methods of root cause analysis to determine the cause of medication errors.7 Cain and Piascik

dialog about how educators can promote healthy perspectives about this uncomfortable topic. In other words, we are going to talk about

describe the use of serious gaming in pharmacy education to promote opportunity for risk-taking and acceptable failure.8 Mattingly

Bruno.

advocates for the inclusion of curricular opportunities for students to take responsible risks without the possibility of jeopardizing or

Discussion

Educator and preceptor perspectives about failure

delaying their career, such as an elective course in entrepreneurship.9 While some of these examples introduce

Pharmacy preceptors fill many roles including student advisors,

students to concepts around medication errors and root cause

mentors, and coaches, and in these roles, should be equipped to

analysis, others showcase that it is possible to provide students

handle discussions about student failure. A natural starting place for

educational opportunities to take risks and talk about some of the

pharmacy preceptors to prepare for these discussions can include

potential areas for failures that they may encounter in their future

some self-reflection. Are we comfortable with the topic of failure? How

careers while still in a safe learning environment.

do we feel about our own failures? Are we comfortable sharing our own shortcomings with our supervisors and mentors?

Carr and colleagues directly interviewed medical students who had to repeat a unit of study to explore the student experience.10 Their

As preceptors work through their own reflections on the topic of failure,

research showed that students felt disappointed in themselves,

it can be helpful to remember that failure is an evitable part of the

shame, and sometimes guilt, feeling that they were letting people

human condition. As Brazeau noted, many pharmacy educators have

down. Other students reported relief as they recognized that they

listened to keynote speakers tell of their successes and often, their stories begin with challenges they had to overcome.2 Each one of us

weren’t ready for the next stage in their learning or that they needed to make changes as they were overextended.10 Importantly, some

will experience failure in some capacity. Some failures that may feel

students reported that they tried to keep the failure to themselves, making the students feel isolated.10 Students have much to tell

familiar to pharmacy preceptors

17

CONT. PRECEPTOR CORNER educators about how to help them through failure when they are provided a safe space to share.11 A pharmacy student recounted

College, school, or institutional strategies to normalize productive

the story of how she encountered several challenges and failures

organization to implement but have the potential for widespread

while trying to complete a research project during pharmacy school.11 Her positivity offers insight both to struggling pharmacy

benefit. It may be helpful to have discussions about failure with

students and preceptors hoping to coach students through a failure.11

school. This information could also be covered annually during a

discussions about failure may take more time, strategy, and

students during orientation or during the first months of pharmacy town hall, lunch and learn, or retreat. Imagine the impact of teaching first year pharmacy students about the power of

Call to Action

embracing a growth mindset, that their challenges can be

The authors of this article propose a few suggestions to spark

embraced, and with persistence, they can grow and improve.12,15

ideas and discussions about handling failures in a productive

Educators can create a culture where students understand that

manner. Some of these ideas can be implemented immediately by

learning is messy, non-linear, and may take a few detours, bumps,

individual educators; others may require thoughtful consideration

and bruises to get to our destinations. By setting an expectation

and implementation at the college or university level.

that educators understand the challenges of the professional training program, students may feel more empowered to come to

In a one-on-one setting, individual preceptors can begin by

educators before challenges become failures. Pharmacy school

discussing failures with students openly and without fear. We can

should be a place where learning occurs, where students are

model healthy attitudes about failure and speak positively about

challenged and encounter setbacks that may ultimately allow them

how our failures have helped us reach new levels of development.

to grow into the professionals they aspire to be. Academic detours

According to Brazeau, as we are all working to ensure our

are part of the process.

students meet key elements of accreditation, “we, collectively, as a group of educators, can provide student pharmacists with our vulnerable stories too.”2 Sharing our failures with students can normalize the discussion about failure and demonstrate the concept that failure is oftentimes a catalyst for growth and the

Institutionally, we can strive to be proactive and recognize that academic setbacks can trigger students to feel shame and embarrassment.10,15 This sentiment is articulated by Elmore,

spark that can propel us towards success. Finally, reinforce

“Each failure seemed a desecration of my work and each rejection a dismissal of my personal worth.”16 Imagine a culture of

positive attitudes about failure in conversations with students on

pharmacy education where students receive coaching that can

an individual level. We can reframe the discussion about an

help them work through these emotions. We can help students

academic failure or remediation opportunities from “failed” to the more growth mindset-oriented term “not yet.”12 Individual

recognize how failures can propel them to a better place and may even be a “blessing in disguise.”17

conversations and mentoring provide an opportunity to reinforce that pharmacy education is a safe space to learn how to become a pharmacist.

Conclusion

In this article, we talked about Bruno, er, failure.1 It wasn’t too awkward, was it? The more we can have healthy, productive

In smaller groups of students, such as with student advising,

dialog about this topic, the better equipped we will be as we

mentoring, and precepting, these concepts can be reinforced and

navigate this uncomfortable yet inevitable element of learning. The

supplemented. Student advising can be a safe space to normalize discussions about a variety of setbacks, from not getting elected to

authors have sought to continue the discussion started by Brazeau, DiPiro, and others by talking about failure.2, 3 We hope

a student leadership position to having a course failure. This might

to normalize discussions like this so we can continue the work of

be a space where a small group would feel comfortable sharing

reframing how failure is viewed in pharmacy education. Let’s talk

their failures, such as a wall of failures or creating a group CV of failures.13,14 Students can learn together how to shape

about failure.

challenges and failures into life lessons. These lessons may even be helpful stories for future situational questions that could be encountered during job or Residency interviews. Reflecting on failures with a small group of students and a mentor can be a positive experience for all.

continued on page 29

18

EDITORIAL Rx AND THE LAW

The Drug Supply Chain Security Act

This series, Pharmacy and the Law, is presented by Pharmacists Mutual Insurance Company and the Arizona Pharmacy Association through Pharmacy Marketing Group, Inc., a company dedicated to providing quality products and services to the pharmacy community.

There is a new regulatory date looming that is very important to pharmacies; November 27, 2024. That is the date that the Food and Drug Administration (FDA) will begin enforcing the requirements of the Drug Supply Chain Security Act (DSCSA). DSCSA was signed into law on November 27, 2013 and requires the ability to track and trace drug products from manufacturers downstream to the ultimate users. The law was implemented in a step-wise fashion over the last ten years. How did we get here and what happens on November 27, 2024?

The DSCSA creates a drug product history, starting with the manufacturer that must be passed on with the product as it is sold or distributed down the supply chain. This encompasses wholesalers, third-party logistics providers, manufacturers, repackagers, and dispensers. The drug product history is not required to be provided by the dispenser to the prescribed patient. Pharmacies must do business with Authorized Trading Partners (ATP).

Pharmacies can check the FDA website to see if their trading partners are authorized. Manufacturers and repackagers must register with FDA, so pharmacies can check registrations on FDA's website. Wholesalers and third-party logistics providers must file an annual report with FDA and pharmacies can verify the report has been filed.

The pedigree provision of the Food, Drug, and Cosmetic Act added by the Prescription Drug Marketing Act of 1987 was replaced on January 1, 2015 by the Product Tracing

requirements of the DSCSA. These requirements mandate the transaction information, transaction history, and transaction statement associated with each drug transaction be captured and provided for most human prescription drugs in finished form. This implementation was not enforced until March 1, 2016 under guidance from FDA. The next major implementation step was the requirement that a product identifier be affixed to the packaging of prescription drugs. This identifier was to be readable by both humans and machines. The product identifier includes the NDC number, serial number, lot number, and expiration date. This requirement was implemented for manufacturers as of November 27, 2017 and repackagers as of November 27, 2018.

For pharmacies, the next implementation date was November 27, 2020. Dispensers would be required to verify the product identifier of at least three packages or ten percent of a suspect product, whichever is greater, or all packages, if there are fewer than three. FDA guidance provides many reasons why a pharmacy may suspect a product is illegitimate. Examples include product sold at extremely low prices, signs of tampering with the packaging, shipping labels indicating the package came from an unexpected source, misspelled words on the packaging, or the product name differs from the FDAapproved name.

19

CONT. RX AND THE LAW Dispensers would also have to verify product in this manner (three packages/ten percent) in response to a notification of illegitimate product from FDA or a trading partner. Again, enforcement of this requirement was deferred until November 27, 2023.

Other requirements from 2020 are in effect now. Dispensers must still only transact products encoded with a product identifier and must comply with other suspect and illegitimate verification requirements.

Pharmacies must have systems and processes in place to address three situations; 1) determining whether a product is suspect, 2) investigating suspect products and quarantining them if found to be counterfeit, or unfit for distribution and potentially dangerous, and 3) notifying FDA if the drug is illegitimate or has a high risk of being illegitimate. This last notification must occur within 24 hours after the determination.

The last piece of the puzzle was to be effective November 17, 2023. Among these requirements, manufacturers, distributors, and dispensers were to provide and receive transaction information and transaction statements in a secure, electronic manner. ATP's must have systems in place to verify product identifiers at the package level.

ATP's must be able to respond to tracing requests and trace products at a package level. On August 25, 2023, FDA announced a one-year stabilization period intended to give ATP's additional time to stabilize their systems and become fully interoperable for secure and timely electronic data exchange. With this announcement, FDA intends to use enforcement discretion until November 17, 2024.

What does all of this mean for pharmacies? Pharmacies should have implemented all of the requirements of the DSCSA by now and be working to test and verify their system is working correctly. If your pharmacy is not in this position today, there is time to work on your implementation before the non-enforcement period ends.

However, depending on where your pharmacy is in the process, completing and testing your system could be a tall order in a short period of time. Resources are available through national and state pharmacy associations and third-party vendors to assist with implementation. Once the non-enforcement period ends, FDA and/or state regulators can bring enforcement actions for violations. Violations could result in seizures of products, court-ordered injunctions, license suspensions or revocations, and civil and criminal fines and penalties, including imprisonment.

The old saying goes that the way to eat an elephant is to do it in small bites. The DSCSA timeline has given pharmacies the chance to implement the requirements in small bites. If your pharmacy is behind, there is still time, but your bites are going to be much larger.

© Don R. McGuire Jr., R.Ph., J.D., is General Counsel, Senior Vice President, Risk Management & Compliance at Pharmacists Mutual Insurance Company.

This article discusses general principles of law and risk management. It is not intended as legal advice.

Pharmacists should consult their own attorneys and insurance companies for specific advice. Pharmacists should be familiar with policies and procedures of their employers and insurance companies, and act accordingly.

20

CONTINUING EDUCATION

Not Just a Pediatric Illness:

Updates on Respiratory Syncytial Virus (RSV) Prevention AUTHORS/CONTRIBUTORS

Pharmacist Learning Objectives: 1. List high risk patient populations that may benefit from RSV prophylaxis.

2. Discuss the changes observed in the RSV season.

3. Describe available RSV agents.

4. Explain key clinical trials

Ariane Guthrie, PharmD, BCPS, BCGP, Clinical Pharmacist Practitioner, Northern Arizona VA

assessing the safety of RSV

Health Care System

agents.

Ivana Kreso, PharmD 2024 Candidate, University of Arizona R. Ken Coit College of Pharmacy

5. Identify appropriate counseling information regarding RSV

FUNDING - This research was not funded

infection prevention.

DISCLOSURES - The authors have no relevant financial relationship to disclose CONTINUING EDUCATION INFORMATION Target Audience: Pharmacists Activity Type: Knowledge

21

CONT. CONTINUING EDUCATION Abstract Respiratory syncytial virus (RSV) is a respiratory infection that can lead to serious complications, especially in high-risk individuals. There has been a recent increase in agents approved by the United States Food and Drug Administration (FDA) for RSV prophylaxis. The following article will provide a review of the currently available RSV agents, their indications for use, available evidence that supported their approval, and clinical considerations for pharmacists and prescribers.

I. Background of RSV RSV is a single-stranded ribonucleic acid (RNA) virus. It can bind to epithelial cells in the nasal cavity and the respiratory tract to cause infections. RSV has two major glycoproteins on its surface that help in the attachment to host cells: the attachment glycoprotein (G) and the fusion (F) glycoprotein.

RSV works by attaching to the host cell and releasing its genetic content into the cell. This allows for the spread, replication, and ultimately leads to illness.1 RSV spreads through respiratory droplets and direct contact.2 For most people without risk factors for RSV complications, it presents like the common cold and symptoms usually resolve within two weeks.3 Children aged two years and younger face heightened risk from RSV infections, especially those with underlying conditions such as prematurity, chronic lung or heart disease, weakened immune systems, neuromuscular disorders, congenital anomalies, or cystic fibrosis.4 RSV risk factors for infants and children include being in childcare or having a sibling who attends childcare or school. Symptoms that are commonly seen in infants and children include rhinorrhea, decreased appetite, cough, sneezing, fever, 5 wheezing, lethargy, irritability, decreased activity, and apnea.

It has been postulated that infants are at a higher risk for RSV infection due to their small bronchioles and narrow luminal diameter, leading to airway obstruction due to cell accumulation. Another possible factor contributing to the heightened risk of RSV infection in infants is their immature immune system.6 In addition to infants and children, older adults who are 65 years and older face an increased risk of RSV infections.

Common conditions that place older adults at a higher risk for developing severe illness from RSV include having underlying lung and cardiovascular disease; being immunocompromised; having diabetes and/or neurologic conditions; and having kidney, liver, or hematologic disorders. Other risk factors include frailty, as well as residence in a nursing home or long-term care facility.

Symptoms that are commonly seen in adults include rhinorrhea, pharyngitis, cough, headache, fatigue, and fever.

Proposed explanations for the elevated risk of RSV infections

among older adults include a higher incidence of comorbidities, immunosenescence, and decreased production of RSV-specific serum and nasal immunoglobulin A (IgA).6 Older adults were previously overlooked with regards to RSV infections, however the need for a prophylactic agent in this population is evident when examining annual RSV-related infection rates and hospitalizations. RSV is estimated to account for 5.0-7.8% of respiratory infections annually among adults.7 While incidence of RSV is lower in adults compared to children and infants younger than six months old, risk of RSV-related complications is relatively higher for older adults (20 per 1,000 versus 27 per 1,000, respectively).8 According to the Centers for Disease Control and Prevention (CDC), there are about 58,000-80,000 hospitalizations for RSV in children less than five years of age annually and about 60,000-160,000 hospitalizations in adults 65 years and older.

9 Regarding RSV-related mortality, CDC reports there are about 6,000 to 10,000 deaths annually among adults 65 years of age and older compared to approximately 100 to 300 deaths annually for children younger than five years old.9 Comparing RSV-related mortality to influenza-related mortality emphasizes the importance of the new RSV agents and their expanded indications. A cross-section study evaluating U.S. death certificates between 1999 to 2018 found that a mean of 23 underlying respiratory deaths annually were associated with influenza among children younger than one year old, versus 96 annual deaths secondary to RSV in this age group (a five-fold increased risk). Both viruses, however, were associated with significant mortality among the elderly. Among adults aged 65 years and older, the mortality rate per 100,000 people was 14.7 for RSV and 20.5 for influenza.10 II. Changes to the RSV Season According to the CDC, the typical RSV season occurs from September to May, with peak activity occurring during the winter season. It is interesting to note that RSV may not follow the “normal” seasonal patterns in all states. In Florida and Hawaii, for example, RSV onset occurs from September to November with peak onset from December to February.9 More recently, changes to the RSV season have been observed as a result of the Coronavirus 2019 (COVID-19) pandemic. Cases of RSV were being reported during the spring season with peaks seen in the middle of July.9 This shift was not only observed with RSV, but with other respiratory diseases as well. The CDC continues to surveil RSV activity to assess whether these peaks will revert to prepandemic trends.

continued on next page

22

CONT. CONTINUING EDUCATION It is also important to note that many of trials leading to FDA approval of newer RSV agents were conducted during the COVID-19 pandemic. Preventative measures (i.e., social distancing, quarantining, and wearing masks in public) likely impacted the spread of not only COVID-19, but other respiratory illnesses such as RSV. It is difficult to account for the impact that these measures played in preventing RSV compared to these studied therapies.

III. RSV Detection and Testing There are multiple methods that can be used to test for RSV, including real-time reverse transcriptionpolymerase chain reaction (rRT-PCR), antigen testing, viral cultures/panels, and serology testing.4 The most commonly used methods for RSV testing include rRT-PCR and antigen testing. Nasal samples should be taken during the first few days of symptom onset because the amountof RSV virus decreases over time.

Molecular testing using rRT-PCR is the most sensitive test in both children and adults, since this method uses RSV genetic material within the testing sample.11 rRT-PCR testing is usually sent to a laboratory for processing andinterpretation which can take several hours to complete. One advantage of rRT-PCR testing is that it can be combined with additional respiratory testing so other causes of illness can be ruled out.

Antigen testing has shown to be less sensitive in adults, presumably because adults tend to have less virus located in their nostrils compared to younger children.11 Some advantages of antigen testing include that it can provide results within an hour, tests are simple to interpret, and they do not have to be sent to a laboratory for processing.

IV. RSV Preventative Agents It is important to note that while there are currently four agents approved by the FDA for RSV prophylaxis, there are no FDA-approved treatments specifically for RSV. Available agents are either monoclonal antibodies (mAb), palivizumab and nirsevimab, or bivalent protein subunit vaccines, Arexvy and Abrysvo. These agents are approved for use in two main populations: infants/children and adults 65 years and older. a. Palivizumab (Synagis) Before 2023, palivizumab was the only RSV agent on the market (Figure 1). Palivizumab is a F protein inhibitor mAb, that works by providing passive immunity to infants and children through the inhibition of the RSV fusion to host cells and as a result it prevents viral replication.

Palivizumab is indicated for use in high-risk infants and children for RSV (Table 1).12 This mAb is administered once a month for up to five months, given its half-life of 20-24.5 days.13

Figure 1: RSV Agent FDA Approval Timeline

i. Palivizumab, a humanized respiratory syncytial virus monoclonal antibody, reduces hospitalization from respiratory syncytial virus infection in high-risk infants (IMpact-RSV).14 The IMpact-RSV trial aimed to evaluate the safety and efficacy of palivizumab in reducing hospitalizations due to RSV among high-risk infants. The trial was a randomized, double-blind, placebo-controlled multicenter study conducted during the 1996-1997 RSV season. The study randomized 1,502 children with prematurity or bronchopulmonary dysplasia to receive either palivizumab or placebo.

This study found that palivizumab prophylaxis reduced hospitalizations among high-risk infants (4.8% in the palivizumab group compared to 10.6% in the placebo group).

The most commonly reported adverse effects were transient erythema and mild-moderate increases in aspartate aminotransferase (3.6% in the palivizumab group compared to 1.6% in the placebo group) and injection-site reactions (2.7% in the palivizumab group compared 1.8% in the placebo group).

One limitation of this study was that there were slightly more households with at least one active smoker in the palivizumab group compared to the placebo group. It should also be noted that this study excluded immunocompromised individuals, those who had seizure disorders, and children with congenital heart disease (except individuals with patent ductus arteriosus or uncomplicated and hemodynamically insignificant septal defect).

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CONT. CONTINUING EDUCATION Table 1: RSV Agent Indications and Eligibility Agent and Manufacturer

Indication and Eligibility • Infants born prematurely (≤ 35 weeks) and who are aged 6 months or less at the beginning of

Palivizumab (Synagis)13 Sobi

RSV season • Infants or children with BPD that need medical therapy within the last 6 months and who are

≤24 months of age at the beginning of RSV season • Infants or children who are born with certain types of heart disease (such as hemodynamically

significant CHD) and who are ≤24 months of age at the beginning of RSV RSVPreF3 OA (Arexvy)26,31 GSK

Nirsevimab-alip (Beyfortus)33 AstraZeneca RSVpreF (Abrysvo)31, 35 Pfizer

• Individuals ≥60 years who are at risk with shared clinical decision-making

• Neonates and infants born during or entering their first RSV season • Children ≤24 months who remain vulnerable to severe RSV disease through their second RSV

season • Individuals ≥60 years who are at risk with shared clinical decision-making • Individuals at 32-36 weeks gestational age of pregnancy

Abbreviations: Sobi, Swedish Orphan Biovitrum AB; GSK, GlaxoSmithKline Pharmaceuticals; RSV, respiratory syncytial virus; CDL, chronic liver disease; BPD, bronchopulmonary dysplasia; CHD, congenital heart disease.

b. RSVPreF3 OA (Arexvy) In May of 2023, the FDA approved GlaxoSmithKline Pharmaceutical’s (GSK) RSV vaccine, Arexvy, for the use in individuals 60 years and older.15Arexvy is an RSV F glycoprotein stabilized in its prefusion form, which is a fusion glycoprotein that has been extracted and stabilized with an AS01B adjuvant. The AS01B adjuvant is a mixture of monophosphoryl lipid A (MPLA) and a saponin derived from 16 Quillaja Saponaria (QS-21). Arexvy is able to create a potent immune response once taken up by host antigen presenting cells. Arexvy is currently recommend as a one-time vaccine.

Ongoing trials are assessing the duration of protection provided

by Arexvy against RSV and the potential need for booster doses. i. Respiratory Syncytial Virus Prefusion F Protein Vaccine in Older Adults (AReSVi-006) Trial17 GSK’s AReSVi-006 trial investigated the efficacy and safety of Arexvy compared to placebo in preventing lower respiratory tract disease in adults 60 years and older during one RSV season.

The trial was a double-bind, placebo-controlled, phase three study that randomized 24,966 adults over the age of 60 years old who were deemed medically stable to receive either Arexvy or placebo.

The study found that Arexvy had an efficacy of 82.6% (96.95% CI, 57.9 to 94.1) in preventing RSV-related lower respiratory tract disease, with 7 cases in the vaccine group and 40 cases in the placebo group. This study examined solicited reactions (injection site pain and fatigue) within four days of treatment administration and found that 71.9% of individuals in the Arexvy group reported a solicited reaction compared to 27.9% of individuals in the placebo group. This study also examined unsolicited reactions within 30 days of treatment administration within a prespecified safety population and found that 14.9% of individuals in the Arexvy group reported an unsolicited reaction while 14.6% of individuals in the placebo reported an unsolicited reaction. They also examined unsolicited reactions within 30 days of treatment administration within the entire study population and found that 33% of individuals in the Arexvy group reported an unsolicited reaction while 17.8% of individuals in the placebo group reported an unsolicited reaction. The study examined serious events, such as atrial fibrillation, that occurred within six months of treatment administration and found that 4.2% of individuals in the Arexvy group reported a serious event compared to 4.0% of individuals in the placebo group. There were three fatal adverse events reported in this study (one associated with cardiopulmonary failure, one associated with a pulmonary embolism, and one associated with an unknown cause).

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CONT. CONTINUING EDUCATION Table 2: Summary of RSV Agents Agent

Dosing

Mechanism of Action

Considerations

• Dosage forms • 50 mg/0.5 mL (0.5 mL) • 100 mg/mL (1 mL) • Use is currently recommended by the AAP based on

Palivizumab (Synagis)13

RSVPreF3 OA (Arexvy)26

15 mg/kg IM once monthly

0.5 mL IM once

Monoclonal antibody (half-life 20-24.5 days)

Bivalent protein subunit with AS01B adjuvant

available data12 • First dose should be administered before the start of the current RSV season • There are separate dosing recommendations for individuals who undergo CPB due to reported decreased in palivizumab serum concentrations12 • Not recommended for use against healthcare associated RSV disease12 • Manufactured as vialed solution

• Dosage forms • 120 mcg/0.5 mL (0.5 mL) • Contains the same adjuvant found in Shingrix • Some formulations contain polysorbate 80 • Manufactured as a 2-vial formulation: the powder vial must be

reconstituted with adjuvant (liquid) vial

Nirsevimab-alip (Beyfortus)33

First RSV season: Weight <5 kg: 50 mg once Weight ≥5 kg:100 mg once

YTE-modified monoclonal antibody (half-life 70-100 days)

Second RSV season: <24 months: 200 mg once

RSVpreF (Abrysvo)35

0.5 mL IM once

Bivalent protein subunit

• Dosage forms • 100 mcg/mL (1 mL) • 50 mg/0.5 mL (0.5 mL) • Provides protection for about 5 months • AAP recommends use to American Indian and Alaska Native

children 8-19 months who are not eligible for palivizumab and who live in remote regions34 • There are separate dosing recommendations for individuals who undergo CPB due to reported decreased in palivizumab serum concentrations12 • Manufactured as prefilled syringes • Dosage forms • 120 mcg/0.5 mL (0.5 mL) • Some formulations contain polysorbate 80 • Manufactured in vials that must be diluted with the provided

diluent

Abbreviations: IM, intramuscular; RSV, respiratory syncytial virus; CPB, cardiopulmonary bypass; AAP, American Academy of Pediatrics

25

CONT. CONTINUING EDUCATION Some strengths of this trial include a high completion rate of 91% in the six-month follow-up period and the examination of immunogenicity for both RSV A and B subtypes. Limitations of this study included the exclusion of immunocompromised individuals and a limited representation of participants aged 80 years or older or those considered frail. Additionally, vaccine protection was only examined for one RSV season and the study was conducted during the COVID-19 pandemic, the latter of which likely explains the relatively low incidence of RSV (only 47 participants reported an episode of RSV-related lower respiratory tract disease).

A strength of this study was that it examined antidrug antibodies after injection, however the impact of these antibodies on subsequent nirsevimab administration is still being investigated. Limitations of this study include that target enrollment was not reached, the study duration coincided with the COVID-19 pandemic, participants were healthy term infants, and the study excluded individuals with renal impairment, hepatic dysfunction, congenital anomaly of the respiratory tract, seizure disorders, congenital heart disease (except uncomplicated), and immunocompromised infants.

c. Nirsevimab-alip (Beyfortus) In July of 2023, the FDA approved AstraZeneca’s Beyfortus (nirsevimab-alip) for infants and children born during or entering their first RSV season and for children up to 24 months who remain vulnerable during their second RSV season (Table 1).18 Nirsevimab is a YTE-modified recombinant human long-acting mAb, which extends the agent’s half-life to 70-100 days.19 It acts by directly fusing to the RSV F protein epitope that inhibits membrane fusion of the virus into the host cell. This agent is given once and provides protection against RSV for several months.19

d. RSVpreF (Abrysvo) In May 2023, the FDA approved Pfizer's vaccine, Abrysvo, for use in individuals aged 60 years and older. Subsequently, in August 2023, the indication was expanded to include pregnant 21 individuals at 32-36 weeks gestation (Table 1). Abrysvo is a bivalent protein subunit vaccine similar to Arexvy, however it does not contain an adjuvant. With its dual indication, the vaccine provides active immunity to adults as well as passive immunity for infants. Abrysvo is currently recommend as a onetime vaccine, however there are ongoing trials to examine the duration of protection against RSV and the potential need for additional boosters.

i. Nirsevimab for Prevention of RSV in Health LatePreterm and Term Infants – (MELODY) Trial20 MedImmue/AstraZeneca and Sanofi’s recent MELODY trial investigated the efficacy and safety of nirsevimab in healthy late-preterm and term infants entering their first RSV season.

The trial was a randomized, phase three, placebo-controlled trial that randomized 1,490 infants born at a gestational age of at least 35 weeks to receive either nirsevimab or a placebo.

i. Efficacy and Safety of a Bivalent RSV Perfusion F Vaccine in Older Adults (RENOIR) Trial22 The RENOIR trial evaluated the immunogenicity, efficacy, and safety of Abrysvo in preventing lower respiratory tract illnesses in adults 60 years and older during one RSV season. The trial was a randomized, phase three, multicentered, placebocontrolled study. The trial randomized 34,284 adults 60 years and older to received either Abrysvo or placebo.

There were 12 infants (1.2%) in the nirsevimab group and 25 infants (5.0%) in the placebo group who developed medically attended RSV-associated lower respiratory tract infections, corresponding to an efficacy of 74.5% (95% CI, 49.6 to 87.1) for nirsevimab. Additionally, nirsevimab demonstrated 62.1% (95% CI, 8.6-86.8) efficacy in preventing hospitalizations for RSV-associated lower respiratory tract infections (0.6% incidence of hospitalizations versus 1.6%). Severe adverse events, defined as events that resulted in death, were lifethreatening, required hospitalization, or caused persistent or significant disability or incapacity, occurred in 3.6% of infants in the nirsevimab group and in 4.3% of infants in the placebo group. In total, three deaths occurred but none were thought to be associated with nirsevimab or placebo. Of note, there was one report of a nirsevimab participant having a grade three generalized macular rash without any systemic features that resolved without treatment after 20 days.

RSV-associated lower respiratory tract illness with at least two signs or symptoms occurred in 11 participants in the Abrysvo group compared to 33 participants in the placebo group, demonstrating a vaccine efficacy of 66.7% (96.66% CI, 28.885.8). Vaccination with Abrysvo also demonstrated 62.1% (95% CI, 37.1-77.9) efficacy in preventing RSV-associated acute respiratory illness (22 cases in the Abrysvo compared to 58 cases in the placebo group). More local site reactions were reported in the Abrysvo group compared to placebo (12% and 7%, respectively), with the most common reaction being injection site pain. Reported systemic events within seven days of treatment were similar between the groups (27% in the Abrysvo group and 26% in the placebo groups). The most commonly reported systemic events were headache and fatigue. Three serious adverse events were considered by the investigators to be related to the trial intervention: one delayed allergic response seven hours after injection, one case of Miller-Fisher syndrome (a variant form of Guillain-Barre syndrome characterized with ophthalmoplegia, ataxia, and areflexia), and one myocardial infarction which occurred six days after injection.

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CONT. CONTINUING EDUCATION One of the strengths of this trial was that most participants had at least one high-risk condition (i.e. tobacco use, diabetes, lung disease, heart disease, liver disease, or renal disease).

Limitations of the study included that protection was only examined for one RSV season, the study was conducted during the COVID-19 pandemic, and immunocompromised individuals were excluded.

to their mother with regards to RSV. Some limitations of this study include the exclusion of individuals characterized as having high-risk pregnancies, those at current risk of preterm birth, those with multiple pregnancies, and infants with clinically significant congenital anomalies. This study was also not powered enough to examine differences in efficacy in RSV antigen subgroups.

ii. Bivalent Prefusion F Vaccine in Pregnancy to Prevent RSV Illness in Infants (MATISSE) Trial23 The MATISSE study assessed the efficacy and safety in preventing RSV-associated lower respiratory tract illness in infants with maternal Abrysvo vaccination compared to placebo. The trial was an international, randomized, phase three, placebo-controlled study. The study randomized 7,392 women at 24-36 weeks gestation with an uncomplicated singleton pregnancy to receive either Abrysvo or a placebo.

There were two primary efficacy end points: medically attended severe RSV-associated lower respiratory tract illness and medically attended RSV-associated lower respiratory tract illness in infants within 90, 120, 150, and 180 days after birth.

V. Clinical Pearls for Pharmacists When considering RSV prophylaxis, it's important to be aware of the differences between agents to select the best one for each individual (Table 2). As with many other vaccines, individuals experiencing any acute illness should not receive RSV vaccines until they are no longer ill.24 RSV vaccines should be avoided in individuals who have experienced severe allergic reactions, such as anaphylaxis to any component of the vaccines.25 For example, if an individual experienced an allergic reaction to the Shingrix vaccine then they should avoid the Arexvy vaccine since both contain the same adjuvant (AS01B).26, 27

Abrysvo only met criterion for vaccine efficacy in regards to medically attended severe lower respiratory tract illness.

Severe lower respiratory illness occurred within 90 days after birth in 6 infants of women in the Abrysvo group compared to 33 infants of women in the placebo group (vaccine efficacy, 81.8%; 99.5% CI, 40.6 to 96.3) and 19 infants in the Abrysvo group compared to 62 infants in the placebo group, after 180 days (vaccine efficacy 69.4% (97.58 CI, 44.3-84.1). Regarding rates of medically attended RSV-associated lower respiratory tract illness, the results of this trial did not show statistical significance. Regarding safety data for mothers, the most frequently reported local reaction within seven days was injection site pain (41% in the Abrysvo group and 10% in the placebo group). The most commonly reported systemic effects were slightly greater in the Abrysvo group compared to placebo (muscle pain reported in 27% and 17%, respectively; and headache reported in 31% and 28%, respectively). Serious maternal adverse events were found to be similar between both the groups. There were four serious adverse events associated with vaccines with mothers (pain in arm followed by bilateral lower-extremity pain, premature labor, systemic lupus erythematosus, and eclampsia). One mother who received the vaccine died from postpartum hemorrhage and hypovolemic shock. Stillbirths occurred in 10% of participants who received the vaccine and in 8% of participants who received placebo.

Infant adverse event rates were similar between the two groups, and there were no serious events in infants considered to be associated with the Abrysvo.

One of the strengths of this trial was that it was the first trial to examine passive immunity to infants from a vaccine given

Another important consideration that has yet to be elucidated is co-administration of RSV agents with other vaccines. Data are currently limited, however the CDC has stated that the RSV vaccines may be administered with other adult vaccines during the same visit.25 When examining co-administration with influenza vaccines, there has been some data showing noninferiority with regards to immunogenicity. Lower antibody titers were observed with co-administration with influenza and RSV vaccines, but the clinical significance of this finding is not fully understood.25, 28, 29 When the Arexvy vaccine was administered with the adjuvanted quadrivalent inactivated influenza vaccine (FLUAD QUADRIVALENT), there was no significant difference in regards to immunogenicity with influenza A subtype H3N2.28,30 Individuals should be counseled about the heightened risk of both local and systemic reactions when multiple vaccines are administered simultaneously.29, 30 When deciding if an individual should receive the RSV vaccine, several considerations are important. These include assessing if they are up to date on all other vaccines, determining if it is feasible for them to return for additional doses, evaluating their risk of contracting RSV, reviewing the vaccine's reactogenicity profiles, and taking into account the individual's preference regarding vaccination.25 Caution should be taken with all individuals who are at an increased risk for bleeding due to the risk of hematoma development.

It is important to note that ongoing trials for the new RSV agents will offer more insights into booster requirements and provide additional safety information. Recommendations are subject to change as more data and post-marketing surveillance becomes available.

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CONT. CONTINUING EDUCATION Non-pharmacologic options should be encouraged with all cases of RSV. This includes frequent handwashing, avoiding exposure to individuals who have confirmed or suspected RSV, keeping common areas clean, not sharing drinking glasses and utensils with others, washing toys or frequently touched surfaces, and avoiding smoking.5, 31 VI. Conclusion There has been an increase in the number of different RSV prophylactic agents available, accompanied by expansions of FDA indications and eligibility criteria for these agents. Pharmacists can play a vital role in educating patients and other healthcare professionals about RSV prophylactic agents. They can significantly contribute to combating RSV infections by identifying high-risk individuals who may benefit from RSV prophylaxis, interpreting the clinical evidence supporting FDA approvals of these agents, and staying updated on newly available options.

References 1. McLellan JS, Ray WC, Peeples ME. Structure and function of respiratory syncytial virus surface glycoproteins. Curr Top Microbiol Immunol. 2013;372:83-104. doi:10.1007/978-3-642-38919-1_4 2. Center for Disease Control and Prevention. Transmission. https://www.cdc.gov/rsv/about/transmission.html (Accessed 2023 Nov 2).

3. Center for Disease Control and Prevention. People at High Risk for RSV. https://www.cdc.gov/rsv/high-risk/index.html (Accessed 2023 Nov 2).

4. Centers for Disease Control and Prevention. For healthcare professionals: RSV (respiratory syncytial virus). https://www.cdc.gov/rsv/clinical/index.html#antibody-product-for-children (Accessed 2023 Sep 23).

5. Mayo Clinic. Respiratory syncytial virus (RSV). https://www.mayoclinic.org/diseasesconditions/respiratory-syncytial-virus/symptoms-causes/syc-20353098 (Accessed 2023 Aug 28).

6. Hu M, Bogoyevitch MA, Jans DA. Impact of Respiratory Syncytial Virus Infection on Host Functions: Implications for Antiviral Strategies. Physiol Rev. 2020;100(4):1527-1594. doi:10.1152/physrev.00030.2019 7. AJMC. Incidence and prevalence of RSV. https://www.ajmc.com/view/incidence-and prevalenceof-rsv (Accessed 2023 Oct 11).

8. Tin Tin Htar M, Yerramalla MS, Moïsi JC, Swerdlow DL. The burden of respiratory syncytial virus in adults: a systematic review and meta-analysis. Epidemiol Infect. 2020;148:e48. Published 2020 Feb 13. doi:10.1017/S0950268820000400 9. Centers for Disease Control and Prevention. RSV surveillance & research. https://www.cdc.gov/rsv/research/index.html (Accessed 2023 Sep 16).

10. Hansen CL, Chaves SS, Demont C, Viboud C. Mortality Associated With Influenza and Respiratory Syncytial Virus in the US, 1999-2018. JAMA Netw Open. 2022;5(2):e220527.

Published 2022 Feb 1. doi:10.1001/jamanetworkopen.2022.0527 11. U.S. National Library of Medicine. (n.d.). Respiratory syncytial virus (RSV) tests: Medlineplus medical test. MedlinePlus. https://medlineplus.gov/lab-tests/respiratory-syncytial-virus-rsv-tests/ 12. American Academy of Pediatrics Committee on Infectious Diseases; American Academy of Pediatrics Bronchiolitis Guidelines Committee. Updated guidance for palivizumab prophylaxis among infants and young children at increased risk of hospitalization for respiratory syncytial virus infection. Pediatrics. 2014;134(2):e620-e638. doi:10.1542/peds.2014-1666 13. Synagis [package insert]. Gaithersburg, MD: MedImmune, LLC.; 2014. (Accessed 2023 Oct 14).

14. Palivizumab, a humanized respiratory syncytial virus monoclonal antibody, reduces hospitalization from respiratory syncytial virus infection in high-risk infants. The IMpact-RSV Study Group. Pediatrics. 1998;102(3 Pt 1):531-537.

15. U.S. Food and Drug Administration. FDA approves first respiratory syncytial virus (RSV) vaccine. https://www.fda.gov/news-events/press-announcements/fda-approves-first-respiratory-syncytialvirus-rsv-vaccine (Accessed 2023 Aug 28).

16. Facciolà A, Visalli G, Laganà A, Di Pietro A. An Overview of Vaccine Adjuvants: Current Evidence and Future Perspectives. Vaccines (Basel). 2022;10(5):819. Published 2022 May 22. doi:10.3390/vaccines10050819 17. Papi, A., Ison, M., Langley, J., Lee, D., Leroux-Roels, I., Martinon-Torres, F., . . . Hulstrøm, V. (2023). Respiratory Syncytial Virus Prefusion F Protein Vaccine in Older Adults. The New England Journal of Medicine, 388(7), 595-608.

18. U.S. Food and Drug Administration. FDA new drug to prevent RSV in babies and toddlers. https://www.fda.gov/news-events/press-announcements/fda-approves-new-drug-prevent-rsvbabies-and-toddlers (Accessed 2023 Aug 28).

19. Zhu Q, McLellan JS, K 20.

21.

22.

23. allewaard NL, et al. A highly potent extended half-life antibody as a potential RSV vaccine surrogate for all infants. Sci Transl Med. 2017;9(388):eaaj1928. doi:10.1126/scitranslmed.aaj1928 24. Hammitt LL, Dagan R, Yuan Y, et al. Nirsevimab for Prevention of RSV in Healthy Late-Preterm

5. Mayo Clinic. Respiratory syncytial virus (RSV). https://www.mayoclinic.org/diseasesconditions/respiratory-syncytial-virus/symptoms-causes/syc-20353098 (Accessed 2023 Aug 28).

6. Hu M, Bogoyevitch MA, Jans DA. Impact of Respiratory Syncytial Virus Infection on Host Functions: Implications for Antiviral Strategies. Physiol Rev. 2020;100(4):1527-1594. doi:10.1152/physrev.00030.2019 7. AJMC. Incidence and prevalence of RSV. https://www.ajmc.com/view/incidence-and prevalenceof-rsv (Accessed 2023 Oct 11).

8. Tin Tin Htar M, Yerramalla MS, Moïsi JC, Swerdlow DL. The burden of respiratory syncytial virus in adults: a systematic review and meta-analysis. Epidemiol Infect. 2020;148:e48. Published 2020 Feb 13. doi:10.1017/S0950268820000400 9. Centers for Disease Control and Prevention. RSV surveillance & research. https://www.cdc.gov/rsv/research/index.html (Accessed 2023 Sep 16).

10. Hansen CL, Chaves SS, Demont C, Viboud C. Mortality Associated With Influenza and Respiratory Syncytial Virus in the US, 1999-2018. JAMA Netw Open. 2022;5(2):e220527.

Published 2022 Feb 1. doi:10.1001/jamanetworkopen.2022.0527 11. U.S. National Library of Medicine. (n.d.). Respiratory syncytial virus (RSV) tests: Medlineplus medical test. MedlinePlus. https://medlineplus.gov/lab-tests/respiratory-syncytial-virus-rsv-tests/ 12. American Academy of Pediatrics Committee on Infectious Diseases; American Academy of Pediatrics Bronchiolitis Guidelines Committee. Updated guidance for palivizumab prophylaxis among infants and young children at increased risk of hospitalization for respiratory syncytial virus infection. Pediatrics. 2014;134(2):e620-e638. doi:10.1542/peds.2014-1666 13. Synagis [package insert]. Gaithersburg, MD: MedImmune, LLC.; 2014. (Accessed 2023 Oct 14).

14. Palivizumab, a humanized respiratory syncytial virus monoclonal antibody, reduces hospitalization from respiratory syncytial virus infection in high-risk infants. The IMpact-RSV Study Group. Pediatrics. 1998;102(3 Pt 1):531-537.

15. U.S. Food and Drug Administration. FDA approves first respiratory syncytial virus (RSV) vaccine. https://www.fda.gov/news-events/press-announcements/fda-approves-first-respiratory-syncytialvirus-rsv-vaccine (Accessed 2023 Aug 28).

16. Facciolà A, Visalli G, Laganà A, Di Pietro A. An Overview of Vaccine Adjuvants: Current Evidence and Future Perspectives. Vaccines (Basel). 2022;10(5):819. Published 2022 May 22. doi:10.3390/vaccines10050819 17. Papi, A., Ison, M., Langley, J., Lee, D., Leroux-Roels, I., Martinon-Torres, F., . . . Hulstrøm, V. (2023). Respiratory Syncytial Virus Prefusion F Protein Vaccine in Older Adults. The New England Journal of Medicine, 388(7), 595-608.

18. U.S. Food and Drug Administration. FDA new drug to prevent RSV in babies and toddlers. https://www.fda.gov/news-events/press-announcements/fda-approves-new-drug-prevent-rsvbabies-and-toddlers (Accessed 2023 Aug 28).

19. Zhu Q, McLellan JS, Kallewaard NL, et al. A highly potent extended half-life antibody as a potential RSV vaccine surrogate for all infants. Sci Transl Med. 2017;9(388):eaaj1928. doi:10.1126/scitranslmed.aaj1928 20. Hammitt LL, Dagan R, Yuan Y, et al. Nirsevimab for Prevention of RSV in Healthy Late-Preterm and Term Infants. N Engl J Med. 2022;386(9):837-846. doi:10.1056/NEJMoa2110275 21. U.S. Food and Drug Administration. FDA approves first vaccine for pregnant individuals to prevent RSV in infants. https://www.fda.gov/news-events/press-announcements/fda-approvesfirst-vaccine-pregnant-individuals-prevent-rsv-infants (Accessed 2023 Aug 28).

22. Walsh, E., Pérez Marc, G., Zareba, A., Falsey, A., Jiang, Q., Patton, M., . . . Schmoele-Thoma, B. (2023). Efficacy and Safety of a Bivalent RSV Prefusion F Vaccine in Older Adults. The New

England Journal of Medicine, 388(16), 1465-1477 23. 2Kampmann B, Madhi SA, Munjal I, et al. Bivalent Prefusion F Vaccine in Pregnancy to Prevent RSV Illness in Infants. N Engl J Med. 2023;388(16):1451-1464. doi:10.1056/NEJMoa2216480 24. Centers for Disease Control and Prevention. Respiratory Syncytial Virus Infection (RSV) VIS. https://www.cdc.gov/vaccines/hcp/vis/vis-statements/rsv.html (Accessed 2023 Oct 13).

25. Centers for Disease Control and Prevention. Use of Respiratory Syncytial Virus Vaccines in Older Adults: Recommendations of the Advisory Committee on Immunization Practices — United States, 2023. https://www.cdc.gov/mmwr/volumes/72/wr/mm7229a4.htm (Accessed 2023 Oct 16).

26. Arexvy [package insert]. Durham, NC: GlaxoSmithKline Biologicals.; 2023. (Accessed 2023 Oct 14).

27. Shingrix [package insert]. Durham, NC: GlaxoSmithKline Biologicals.; 2023. (Accessed 2023 Nov 15).

28. Friedland L. GSK’s RSVPreF3 OA vaccine (AREXVY) [Presentation slides]. Presented at the Advisory Committee on Immunization Practices meeting, Atlanta, GA; June 21, 2023. https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2023-06-21-23/03-RSV-AdultsFriedland-508.pdf (Accessed 2023 Nov 5).

29. Gurtman S. RSVpreF older adults clinical development program updates [Presentation slides].

Presented at the Advisory Committee on Immunization Practices meeting, Atlanta, GA; June 21, 2023. https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2023-06-21-23/02-RSVAdults-Gurtman-508.pdf (Accessed 2023 Nov 5).

30. Centers for Disease Control and Prevention. Weekly U.S. Influenza Surveillance Report. https://www.cdc.gov/flu/weekly/index.htm (Accessed 2023 Nov 5).

31. Centers for Disease Control and Prevention. RSV Prevention. https://www.cdc.gov/rsv/about/prevention.html (Accessed 2023 Nov 4).

32. Centers for Disease Control and Prevention. CDC Recommends RSV Vaccine For Older Adults. https://www.cdc.gov/media/releases/2023/s0629-rsv.html (Accessed 2023 Oct 16).

33. Beyfortus [package insert]. Sodertalje, Sweden: AstraZeneca AB.; 2023. (Accessed 2023 Oct 14).

34. Nirsevimab frequently asked questions. Home. Accessed November 15, 2023. https://www.aap.org/en/patient-care/respiratory-syncytial-virus-rsv-prevention/nirsevimabfrequently-asked-questions/ (Accessed 2023 Nov 15).

35. Abrysvo [package insert]. New York, New York: Pfizer Labs.; 2023. (Accessed 2023 Oct 14).

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AZPA CONTINUING EDUCATION Assessment Questions 1. Which of the following accurately lists risk factors for infants and children in developing severe illness from Respiratory Syncytial Virus (RSV)?

A. Full-term birth, chronic lung disease, congenital heart disease B. Homeschooled, full-term birth, immunosuppressed C. Prematurity, congenital heart disease, immunosuppressed D. Prematurity, homeschooled, congenital heart disease 2. Which of the following RSV agents are vaccines?

A. Abrysvo, Arexvy B. Arexvy, Beyfortus C. Beyfortus, Synagis D. Synagis, Abrysvo 3. Which RSV agent is FDA-approved for use during pregnancy?

A. Abrysvo B. Arexvy C. Beyfortus D. Synagis 4. Which of the following individuals should receive RSV prophylaxis?

A. 4-year-old with cystic fibrosis B. 12-year-old with seasonal allergies C. 28-year-old with chronic obstructive pulmonary disease D. 55-year-old with benign prostatic hyperplasia 5. Which RSV agent would be appropriate for use in a 72-year-old with a reported allergy to the recombinant zoster vaccines?

A. Abrysvo B. Arexvy C. Shingrix D. Synagis

Continued from page 18 REFERENCES 1. Miranda L. “We don’t talk about Bruno” in Encanto. Disney; 2021.

2. Brazeau GA. Share all your stories. Am J Pharm Educ. 2018;82(10):7434. DOI: https://doi.org/10.5688/ajpe7434.

3. DiPiro JT, Chisholm-Burns MA. Fail fast. Am J Pharm Educ. 2013;77(8):159.

DOI: https://doi.org/10.5688/ajpe778159 4. Nohria R, McBane S. The impact of failure on faculty development. Curr Pharm Teach Learn. 2022;14(2):123-126. DOI: https://doi.org/10.1016/j.cptl.2021.11.016 5. Ragucci KR, Kern DH, Shrader SP. Evaluation of interprofessional team disclosure of a medical error to a simulated patient. Am J Pharm Educ.

2016;80(8):138. DOI: https://doi.org/10.5688/ajpe808138 6. Poirier TI, Pailden J, Jhala R, Ronald K, Wilhelm M, Fan J. Student selfassessment and faculty assessment of performance in an interprofessional error disclosure simulation training program. Am J Pharm Educ. 2017;81(3):54 [published correction appears in Am J Pharm Educ. 2017 Aug;81(3): S7]. DOI: https://doi.org/10.5688/ajpe81354 7. Frenzel JE, Skoy ET, Eukel HN. Use of simulations to improve pharmacy students knowledge, skills, and attitudes about medication errors and patient safety. Am J Pharm Educ. 2018;82(8):6644. DOI: https://doi.org/10.5688/ajpe6644 8. Cain J, Piascik P. Are serious games a good strategy for pharmacy education?

Am J Pharm Educ. 2015;79(4):47. DOI: https://doi.org/10.5688/ajpe79447 9. Mattingly TJ 2nd, Abdelwadoud M, Mullins CD, Eddington ND. Pharmapreneur defining a framework for entrepreneurship in pharmacy education. Am J Pharm Educ 2019;83(10):7548. DOI: https://doi.org/10.5688/ajpe7548 10. Carr SE. Wearn A, Canny BJ, Carmody D, Balmer D, Celenza A, Diug B, Leech M, Wilkinson TJ. When the wheels fall off – Medical students’ experiences of

6. What is the primary mechanism of action of Nirsevimab in preventing RSV infection?

A. Enhancing antibody production B. Inducing passive immunity C. Inhibiting RSV fusion to host cells D. Stabilizing RSV glycoproteins 7. Which FDA-approved RSV prophylactic agent is administered once a month for up to five months?

A. Abrysvo B. Arexvy C. Nirsevimab D. Palivizumab 8. During the Nirsevimab for Prevention of RSV in Health LatePreterm and Term Infants – (MELODY) Tria, which group had a higher percentage of infants experiencing severe adverse events, defined as events that resulted in death, were life-threatening, required hospitalization, or caused persistent or significant disability or incapacity?

A. Both groups had the same percentage B. Nirsevimab group C. Placebo group REFERENCES

9. Which of the following is NOT a recommended non-

pharmacologic measure toBruno” encourage in cases RSV? 1. Miranda L. “We don’t talk about in Encanto.

Disney;of2021.

A. Avoiding exposure to individuals with confirmed or suspected 2. Brazeau GA. Share all your stories.

Am J Pharm Educ.

2018;82(10):7434.

DOI: https://doi.org/10.5688/ajpe7434.

RSV 3. DiPiro JT, Chisholm-Burns MA. Fail fast. Am J Pharm Educ. 2013;77(8):159.

B. Avoiding smoking DOI: https://doi.org/10.5688/ajpe778159 C. Sharing drinking glasses and utensils others Curr Pharm 4. Nohria R, McBane S. The impact of failure on facultywith development.

D. Washing toys or frequently surfaces Teach Learn. 2022;14(2):123-126.

DOI: touched https://doi.org/10.1016/j.cptl.2021.11.016 5. Ragucci KR, Kern DH, Shrader SP. Evaluation of interprofessional team disclosure of astatement medical error to adescribes simulated patient.

Am in J Pharm 10. Which best the shift peak Educ. cases of RSV 2016;80(8):138. DOI: https://doi.org/10.5688/ajpe808138 due to the COVID-19 pandemic?

6. Poirier TI, Pailden J, Jhala R, Ronald K, Wilhelm M, Fan J. Student selfA. Fall instead of assessment winter. assessment and faculty of performance in an interprofessional error B. Spring season instead of winter. disclosure simulation training program.

Am J Pharm Educ. 2017;81(3):54 [published correction appears in Am Pharm Educ. 2017 Aug;81(3): S7]. DOI: C. Winter season instead ofJfall. https://doi.org/10.5688/ajpe81354 D. Winter season instead of spring.

7. Frenzel JE, Skoy ET, Eukel HN. Use of simulations to improve pharmacy students knowledge, skills, and attitudes about medication errors and patient safety. Am J Pharm Educ. 2018;82(8):6644. DOI: https://doi.org/10.5688/ajpe6644 8. Cain J, Piascik P. Are serious games a good strategy for pharmacy education?

Am J Pharm Educ. 2015;79(4):47. DOI: https://doi.org/10.5688/ajpe79447 9. Mattingly TJ 2nd, Abdelwadoud M, Mullins CD, Eddington ND. Pharmapreneur defining a framework for entrepreneurship in pharmacy education. Am J Pharm Educ 2019;83(10):7548. DOI: https://doi.org/10.5688/ajpe7548 10. Carr SE. Wearn A, Canny BJ, Carmody D, Balmer D, Celenza A, Diug B, Leech M, Wilkinson TJ. When the wheels fall off – Medical students’ experiences of interrupted academic progression. Med Teach. 2022;1-8. DOI: https://doi.org/10.1080/0142159X.2022.2055455 11. Tilley M. Reality versus expectation: lessons learned through a failure during pharmacy school. https://www.idstewardship.com/reality-versus-expectationlessons-learned-failure-pharmacy-school/ Published May 24, 2020. Accessed May 20, 2022.

12. Dweck CS. Mindset, The New Psychology of Success. Random House Digital; 2008.

13. Stefan M. A CV of failures. Nature. 2010:468;467. DOI: https://doi.org/10.1038/nj7322-467a 14. Orsini P. ‘Failure wall’ inspires success. https://www.cnbc.com/id/46101756 Published January 23, 2012. Updated January 27, 2012. Accessed May 20, 2022.

15. Bynum WE, Varpio L, Lagoo J, Teunissen PW. ‘I'm unworthy of being in this space’: The origins of shame in medical students. Med Educ. 2021;55:185-197.

DOI: https://doi.org/10.1111/medu.14354 16. Elmore L. On failures and rejections. Am J Health-Syst Pharm. 2012;69:924-926.

DOI: https://doi.org/10.2146/ajhp110441 17. Goodman M, Gauthier TP. Five reasons why people fail in pharmacy school. https://www.idstewardship.com/five-reasons-people-fail-pharmacy-school/ Published November 7, 2017. Accessed May 20, 2022.

29

EDITORIAL UNIVERSITY & ALUMNI

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

Computational drug discovery could open new doors Imagine you have a key chain with four keys on it, and the locksmith down the road has a key chain with 500 keys.

You would be able to open some doors and the locksmith would be able to open more, but neither of you will be able to open every door you come across. This is similar to the practical challenges pharmaceutical researchers have faced when discovering new therapeutics.

Historically, scientists physically tested a collection of thousands of candidate drugs to see what effect they might have. Over time, computational approaches have made the process more efficient, but advancement has needed to be faster, and drug discovery is still considered to be time consuming and expensive.

“A protein folds into a three-dimensional structure with little pockets or cavities that allow it to bind to something.

The key-in-lock interaction is called drug binding and produces results by changing something about how the protein works,” Dr. Wheeler said. “This is where drug discovery comes in. For example, if you find a pocket that a virus needs for replicating itself, you might be able to pour something into it and stop it from replicating.”

Travis Wheeler, PhD, associate professor in the R. Ken Coit College of Pharmacy, and his team at the University of Arizona Health Sciences are developing cutting-edge machine learning techniques that they expect will bring costs down and make new discoveries possible. He uses the analogy of finding a key for a locked door.

“You and the locksmith might find a company that could provide you with 500,000 keys, but that would take a long time to try one-by-one manually,” Dr. Wheeler said. “Our technology is like being able to take a picture of the lock you want to open and having a computer rapidly scan through hundreds of thousands of keys to provide you with a few worth trying on the door.”

Providing researchers with computational tools Most people only think about protein when looking at a nutrition label, but every human can thank tens of thousands of proteins for making their life possible. All the cells in the body stay alive and perform their necessary functions by producing and organizing proteins. Proteins are also key players in different stages of disease progression and are critical to the functions of viruses.

When these proteins do not work as expected, or when bacteria or viruses produce proteins that interfere with the workings of our cells, drugs can be used to set things right. A drug is simply a small molecule that fits into a targeted protein, much like a key might fit into a lock.

Travis Wheeler, PhD, and his team at the R. Ken Coit College of Pharmacy are developing software to aid in identifying drugs for target proteins and for predicting possible side effects.

Unlike some health sciences researchers, Dr. Wheeler’s group concerns itself more with computation than with the human body. They develop algorithms, machine learning methods and software implementations. However, they do direct these tools toward problems that often arise when analyzing biological data.

“A lot of what we do is build tools that biologists of all stripes can use to understand what are the contents of a genome or what are the functional parts of proteins. One natural offshoot of that work is drug discovery,” said Dr. Wheeler.

To make drug discovery a more efficient process, the group is developing software to aid in identifying drugs for target proteins and for predicting possible side effects.

Similar to how an advanced search engine works, the computer learns from hundreds of thousands of examples to gain insight into the process of drug binding. The software will be able to rapidly

continued on next page

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CONT. UNIVERSITY & ALUMNI

scan billions of small molecules for expected interactions and to recognize relationships between chunks of protein sequences. This work could lead to novel treatments and address issues related to infection, immunity and inflammation.

“We hear a lot about machine learning and artificial intelligence and how this will change many fields of life, including health and cures for diseases,” said Janko Nikolich, MD, PhD, head of the UArizona College of Medicine – Tucson’s Department of Immunobiology and the UArizona Health Sciences’ Personalized Defense initiative, which is helping fund some of Dr. Wheeler’s drug discovery efforts.

“Dr Wheeler’s work will put this into practice, and help us fast-discover new drugs to, for example, stop the next pandemic or treat currently untreatable chronic diseases.”

Helping more patients According to Dr. Wheeler, advancements in computational drug discovery are particularly important for diseases that do not produce profitable revenue streams for pharmaceutical companies. For very large drug searches, physical discovery can cost tens of millions of dollars to find a potential drug target. When dealing with a condition like hypertension that effects millions of people, pharmaceutical

companies have incentive to spend that upfront cost. But for rarer conditions, or for conditions mainly afflicting poor populations, that upfront cost can be a barrier to finding therapeutics. Dr. Wheeler explains what a binding pocket is and how the process of drug binding helps identify new drug targets.

“These computational approaches explore a much wider diversity of candidate molecules. That increases the chance that you will be able to find something that otherwise would not have been found, and it can be done much cheaper and much faster,” said Dr. Wheeler.

“Potential cures might be identified for smaller groups, and the price of those drugs could be more affordable.”

Dr. Wheeler says his work in computer science has always been driven by intellectual curiosity and the rewarding feeling of solving complex puzzles. His computational drug discovery work delivers those feelings with the added benefit of being able to help people.

“I’ve got the best job in the world,” he said. “A lot of people buy books filled with word or number puzzles. But instead of needing to buy those, I get paid to work out solutions to really complicated problems. And it’s also rewarding, because I’m able to use these computational and statistical methods that I have learned to potentially make an impact on someone’s life or on the state of human health in general.”

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EDITORIAL UNIVERSITY & ALUMNI

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

Seasons Greetings from the College of Pharmacy at Midwestern University!

Greetings from the College of Pharmacy at Midwestern University. As we welcome 2024, we are reminded of the many accomplishments of our faculty, staff, students, alumni, and friends. As always, we want to highlight and celebrate all our milestones.

Campus life has been busy with preparation plans for the Spring Quarter, celebrating Residency Match and the Class of 2024 Graduation, and welcoming the Class of 2027 this summer. Things can never be planned too early! We are excited to get a refresh in Cholla Hall (home to much of the pharmacy program) this spring and early Summer.

Residency Match Day was March 13th, and we are proud of the Class of 2024 as we had the highest percentage of any class to Match. CPG had 28 students match in Phase I and we expect several others to match in Phase II. Practice sites range from Community Pharmacies to HealthSystems including several Veterans Affairs facilities, Teaching and Community Hospitals, and clinics. Many of the class will remain in Arizona to complete their training; however, they will be distributed all over as this dynamic class is going coast-to-coast.

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

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.

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

On Saturday, March 23rd we hosted the College of Pharmacy Alumni and Friends reception in Orlando in conjunction with the American Pharmacists Associations Annual Meeting (APhA). We had an incredible reception at The Hampton Social- Orlando. Thank you to our faculty, staff, alumni, students, and friends who stopped by to join us. I hope you had the chance to enjoy the incredible meeting and all of what Orlando has to offer.

As noted above, we’re counting down until we celebrate our newest graduates. The final day of rotations is May 10th and we will host the class for an Awards Ceremony and BBQ. Graduation is scheduled on May 30th at 12pm with a festive reception following the ceremony. All are welcome to celebrate the Class of 2024. The events continue as we host our annual College of Pharmacy Dessert Reception in conjunction with the annual AzPA conference at the Hilton Phoenix Resort at the Peak. We hope you will plan to join us on Friday, June 7th. Look for more details as the date draws near.

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EDITORIAL UNIVERSITY & ALUMNI

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

Creighton addresses healthcare needs in Southwest Arizona is one of the fastest growing states in the U.S., and Creighton University’s infusion of health professionals comes at a crucial time for the state that is experiencing a population boom and shortfall of healthcare providers simultaneously.

It’s estimated that by 2030, Arizona will have a shortage of 50,000 nurses and a physician-patient ratio of 1:1,500. It’s a potential quality care crisis that Creighton is addressing now.

“The Creighton University Arizona Health Education Alliance is an important addition to Phoenix’s healthcare community, which faces a critical shortage of healthcare professionals to service the region’s diverse population,” says Kevin Howard, director of recruitment for the School of Pharmacy and Health Professions. “The Creighton Alliance provides students essential hands-on patient-care experience at mission-focused Phoenix healthcare facilities.”

Creighton University’s campus in Omaha, Nebraska, joins its Phoenix counterpart to address this shortage through innovative programming, pipelines between the two campuses and community partnerships to graduate healthcare professionals exceptional in their expertise and compassionate in their care.

Creighton’s proactive approach includes: · Doctor of Pharmacy Early Assurance Program

What: High school seniors who meet certain criteria for admission and progression can apply for admission to the University’s Doctor of Pharmacy Program.

How: Students who begin their academic careers at Creighton’s Omaha campus can complete their doctorate in Omaha or transfer to the University’s Phoenix campus to finish their PharmD degree, for a total of two years of undergrad in Omaha and four years of pharmacy at either campus.

“We will be graduating our first PharmD class at the Phoenix campus in 2025, and the majority of these students are planning to remain in Arizona,” says Timothy Ivers, PharmD, assistant professor of pharmacy practice at Creighton’s School of Pharmacy and Health Professions.

Innovative and Flexible Entry-level PharmD Program

What: Housed in the 195,000-square foot, state-of-the-art Creighton-Phoenix campus, this hybrid pathway combines distance learning for the didactic portion of the curriculum and cutting-edge technology and equipment for the clinical lab component of the curriculum.

How: Students benefit from a program that includes distance learning opportunities that can be tailored their schedules as well as necessary hands-on instruction “designed to promote interactive and interdisciplinary learning for future clinicians in pharmacy,” says Howard.

The program’s structure is appealing to PharmD students and thus helps to draw more to the program, which is good for the Greater Phoenix area.

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EDITORIAL UNIVERSITY & ALUMNI Community Partnerships

3+4 Dual Degree PharmD Program with ASU

What: Partnerships provide students with hands-on learning and service opportunities and fill a need within the community. Partnerships include Shoo the Flu Clinics on Creighton’s campus; First Place, an organization dedicated to fostering independence for adults with autism and other neurodiversity conditions; and the Virginia G. Piper Medical Clinic.

What: Students can earn a bachelor’s degree at Arizona State University and then complete their PharmD degree Creighton in Phoenix. Students typically apply to the PharmD program during their junior year at ASU and then start the program during their senior year, receiving their bachelor’s after the fourth year.

How: Partnerships with Arizona institutions such as ASU strengthens ties to their home state for Arizonians as well as draws new inhabitants to the area.

How: As students integrate into local populations, they form connections that create a sense of community and belonging.

Experiential Learning

What: Foundational skills acquired in the classroom are reinforced with time spent in a variety of pharmacy settings – community pharmacy, acute pharmaceutical care, inpatient hospital and outpatient clinic – throughout the Greater Phoenix area. In fact, it comprises 30 % of the curriculum, providing practice that is completed in a realworld pharmacy setting.

Creighton University is one of the largest Catholic health professions educators in the U.S. And with its focus on academic excellence and the Jesuit value of cura personalis – care for the whole person – it brings quality of care to the Southwest.

How: Such interaction between local pharmacists and Creighton’s PharmD students provides students invaluable skill development – patient counseling and client interaction, for instance – and employers the chance to meet future employees. “We receive great feedback from pharmacists who work with our pharmacy interns,” says Ivers.

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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.

REGISTER NOW 35

EDITORIAL PAAS NATIONAL

Continuous Glucose Monitor (CGM) Billing and Supply Allowance CMS has issued an update on the Glucose Monitor Policy Article1 effective as of January 1, 2024. A supplier now has the option to bill and dispense up to a 90-day supply for procedure codes A4238 (Adjunctive CGM) and A4239 (Non-Adjunctive CGM).

Below is a helpful chart to categorize the Dexcom and FreeStyle CGM products, their respective NCPDP billing units, and corresponding days’ supply.

The policy article states: “Up to a maximum of three (3) months, ninety (90) days of the supply allowance may be billed for code A4238 or A4239 to the DME MAC at a time and suppliers may not dispense more than a ninety (90) day supply.”

Product

NDC

NCPDP Billing Unit

Day's Supply

Dexcom G6 Receiver

08627-0091-11

1 Each

Once a year

Dexcom G6 Transmitter

08627-0016-01

1 Each

Every 3 months

Dexcom G6 Sensor

08627-0053-03

1 Each

Every 30 days

Dexcom G7 Receiver

08627-0078-01

1 Each

Once a year

Dexcom G7 Sensor

08627-0077-01

1 Each

Every 10 days

FreeStyle Libre 14-day Sensor

57599-0001-01

1 Each

Every 14 days

FreeStyle Libre 14-day Reader

57599-0002-00

1 Each

Every 3 years

FreeStyle Libre Reader

57599-0000-21

1 Each

Every 3 years

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CONT. PAAS NATIONAL PAAS Tips: • When billing Medicare Part B claims for procedure codes A4238 or A4239, claims are billed as 1 unit of service (UOS) per 30 days • The NCPDP billing units shown in the chart above would apply to non-Medicare Part B claims • A CGM supply allowance includes all items necessary for the use of the device and includes, but is not limited to, CGM sensors and transmitters • For adjunctive CGMs , the supply allowance code (A4238), does not include supplies for a Blood Glucose Monitor (BGM.). Any required BGM supplies must be billed separately • For non-adjunctive CGMs, the supply allowance code (A4239), also includes a home BGM and related supplies in the bundled payment (test strips, lancets, lancing device, calibration solution, and batteries) • The supplier must monitor usage and verify the beneficiary has sufficient supplies to last for each 30day billing period • Utilize the CGM Supply Allowance Billing • Calculator found on your DME MAC website to help determine when the next date of service can be billed 2 • CGS 3 • Noridian 4 • Check the same/similar tool in myCGS for a complete claim history to be sure the patient has not received supplies from another supplier in the last 30 or 90 days·

• If the patient requires a replacement sensor, transmitter,

or receiver due to a product failure, be sure to document and replace the item while reaching out to the manufacturer • Beware that any PBM, including Medicare B, will recoup or deny a claim if it is refilled too soon based on days’ supply guidelines above

By Trenton Thiede, PharmD, MBA, President at PAAS ® National , expert third party audit assistance, FWA/HIPAA and USP 800 compliance.

References: 1. https://www.cms.gov/medicare-coveragedatabase/view/article.aspx?articleId=52464&ContrID=140 1. https://www.cgsmedicare.com/medicare_dynamic/jc/ k0553/index.aspx 3. https://med.noridianmedicare.com/web/jadme/searc h-result/-/view/2230703/continuous-glucose-monitor-cgmsupply-allowance-calculator 4. https://mycgsportal.com/mycgs/ Copyright © 2024 PAAS National, LLC. Unauthorized use or distribution prohibited. All use subject to terms at https://paasnational.com/terms-of-use/.

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ADVOCACY PHARMACY DAY

Pharmacy Day at the Capitol March 20th was our annual Pharmacy Day at the Capitol!

We had over 100 pharmacy professionals including pharmacists, pharmacy technicians and pharmacy students from all three Arizona colleges of pharmacy! We met with over 40 legislators to communicate the education need to obtain a Doctor of Pharmacy degree and the specialized certifications available. During the meetings, our volunteers discussed Payment for Pharmacist Services, PBM Abuses, and Test and Treat.

LOCATION

Arizona State Capitol Complex 1700 W. Washington St | Phoenix, AZ 85007

In addition to the meetings, over 75 legislators and staffers joined us for lunch at Wesley Bolin Plaza.

Thank you to everyone who came out to make this day a success!

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ADVOCACY PHARMACY DAY CONT.

Meeting with Representative Seaman Left to right: Ken, Joseph, Miranda, Ivan, Josalynn

Meeting with Senator Bravo Left to right: Gabriela, Denise, Sarah, Michael, Melinda

Meeting with Representative Leo Biasiucci Right to left: Dawn, Jarrod, Shams, Ashkan

Meeting with Representative Liguori Left to right: Jeffrey, Glory, Kelly, Jacob, Marcus

Meeting with Representative Patricia Contreras Left to right: Lillianne, Mariphil, Jan, Sammy

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