AJP Spring 2022

Arizona Journal of Pharmacy O F F I C I A L P U B L I C AT I O N O F A R I ZO N A P H A R M A CY A S S O C I AT I O N | S P R I N G 2 0 2 2

AzPA ANNUAL CONVENTION Coming Together to Advance Arizona Pharmacy ARIZONA GRAND RESORT & SPA l JUNE 16-19, 2022

SAV E TH E DATES April 23, 2022

AzPA Immunization Training Certificate Program Glendale, AZ August 27, 2022 | Virtual

May 23, 2022

APhA Pharmacist & Patient - Centered Diabetes Care, Glendale, AZ

June 3, 2022

AzPA Anticoagulation Certificate Program

June 4, 2022

AzPA Psychiatric Certificate Program

June 16-19, 2022

AzPA Annual Convention Arizona Grand Resort & Spa

June 16, 2022

Southwestern States Residency Conference 2 SPRING 2022

CONTENTS COVER STORY BOARD OF DIRECTORS 2021–2022 OFFICERS President Darren Clonts President Elect Dawn Gerber Past President Jacob Schwarz Treasurer Stephanie Spark Secretary Nancy Costlow Director/CEO Kelly Fine

DIRECTORS AT LARGE Community Pharmacy Phillip Ieng Health System Pharmacy Christopher Edwards Technician Melinda Browning Directors at Large Reasol Chino Laura Carpenter Erin Epley Kimberly Langley Nina Vadiei

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LIAISONS Raman Kaur Student Pharmacist Academy University of Arizona David Halterman Student Pharmacist Academy Midwestern University Roger Morris, RPh, JD Legal Counsel Nancy Alvarez Designated Representative University of Arizona Michael Dietrich Designated Representative Midwestern University Jane Stein Designated Representative Creighton University

President’s Message 4 AzPA News Welcome New Members 5 Annual Convention Highlight 12 University & Alumni News 31

Editorial A Preceptor’s Guide to Critical Thinking 6

AzPA STAFF Chief Executive Officer Kelly Fine Operations Cindy Esquer EDITOR Kelly Fine, RPh, FAzPA MANAGING EDITOR Cindy Esquer

Arizona and COVID-19: Two-Year Experience 24 Rx and the Law: Emergency Use Authorizations 34 Financial Forum: College Funding Choices. 36 Best Practices for Vaccine Documentation. 38

CREATIVE COORDINATOR Elizabeth Nelson, CAE

The interactive digital version of the Arizona Journal of Pharmacy is available for members only online at www.tinyurl.com/azjournal (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 Pharmacy Network of Arizona at: 1845 E. Southern Avenue, Tempe, AZ 85282-5831.

Continuing Education Spot the Difference: Outlining the Key Distinctions Between Crohn’s Disease and Ulcerative Colitis with Emphasis on Evidence-Based Treatment Recommendations 20

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president’s m es sa ge

Darren Clonts, PharmD, MBA, BCACP As the Pharmacy Performance Quality Lead at Cigna Medical Group (CMG), Darren Clonts has responsibility for valuebased pharmacy quality across Medicare, Medicaid, and Commercial lines of business.

Throughout his career at CMG, he has been involved in the design and implementation of novel clinical pharmacy programs including collaborative practice diabetes management, transition of care services, centralized refill services and quality measure performance.

Following graduation from the University of Arizona College of Pharmacy, he received a Master’s in Business Administration from the University of Phoenix School of Business and was certified as a Lean Six Sigma Greenbelt in process improvement. Prior to becoming President of the Association, he served on the Board of Directors as the Managed Care Academy Chair.

4 SPRING 2022

Dear AzPA Members,

I hope this letter finds you well. Thank you for your membership in this great organization. Thank you for the role you play daily in the lives of our patients. As I attempt to imagine individually all your stories of patient care that are transpiring every day, most of which remain untold, it is inspiring and no surprise that patients repeatedly report having a high level of trust in the pharmacy profession.

A number of years ago, I had the opportunity to go backpacking in the Uinta Mountains and hike one of the tallest peaks in Utah known as Kings Peak. We went with a family friend, who served as our guide, which was much needed since we were unfamiliar with the area. Having a guide was beneficial for several reasons including preparation on what to bring, where to find water and how to navigate to our location. The hike was difficult, but eventually we reached the top and spent time admiring the breathtaking view that is difficult to describe in words. However, the most important reason for having a guide came on our descent. Upon arriving towards the bottom, we were hit with a ferocious storm with high winds, hail, and lighting. I can remember feeling concerned about being struck by lighting and holding together my wind torn plastic rain poncho as the hail was stinging my exposed hand. Our guide was able to quickly get us to an area of safety by taking a different path back to our camp.

My purpose in sharing this story is simply to highlight how having an experienced guide can help us move forward, even when we run into obstacles. In the area of legislative advocacy, AzPA serves as our guide and helps us to prepare and navigate what most of us would consider “unfamiliar territory”. I am grateful for the experience brought and time volunteered by our CEO, staff, partners, legislative committee chairs, committee members and general members in support of our AzPA legislative efforts.

Which leads to the question. How can we as members of AzPA continue to support the advancement of our profession? It is important that we never assume that it will be taken care of for us. As the quote says “if it is to be, it is up to me”. It takes all of us working together to obtain the outcomes we are looking for. Below are a few ways we can help: 1. Continue to be an AzPA member and help encourage others to join to grow our voice 2. Share your ideas for change with AzPA and our legislative committee

3. Consider joining and volunteering your time as part of our legislative committee 4. Respond to AzPA Call to Action Requests

5. Participate in Pharmacy Day at the Capital

There are many ways to be involved. I would encourage each of you to consider one or more of these in the coming year. Thank you for your support of AzPA and the Pharmacy Profession in Arizona.

Best Regards,

Darren Clonts, PharmD, MBA, BCACP AzPA President

AzPA news

Welcome New Members

1st Year Practitioner Valerie McLeod Briana White 2nd Year Practitioner Carlos Bejarano Marie Pais

Theresa Taylor Anthony Que Zachary Lancaster Leann Christian Stephen Borowy Patience Dzilala Zareen Zeller Elaheh Mehrabkhani Kelly Marie McLean

Associate Christopher Santarone Pharmacist Jessica Hasty Stephen Bond Sandra Guckian Julia Olson Molly Bettridge Carolyn Smith Melissa Sanders

Premium Pharmacist Monika Debski Kayla Deacon Jerrica Dodd Natalie Salese

Retired Olugbenga Oduyale Steven M. Lerch Student Pharmacist Skylar Van Patter Mariah Duran Jason Do Erica Sawires Paula Beatty Cindy Nguyen George Seif Technician Christi Carter 

Resident Banin Alqadheeb Paula Yonosko

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editorial prece p t or c or n e r

A Preceptor’s Guide to Critical Thinking Suzanne Larson, PharmD, Director of Experiential Education, Midwestern University College of Pharmacy-Glendale Janet Heather Cooley, PharmD, Director of Experiential Education, University of Arizona College of Pharmacy.

Acknowledgement

None

Funding

This research was not funded.

Conflict of Interest

The authors declare that there are no conflicts of interest.

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Over the last several decades of pharmacy practice, pharmacists have transitioned from being the stewards of drug knowledge and the dispensers of medication to professionals providing direct patient care in a variety of settings. To meet the demands of the rapidly evolving pharmacy practice landscape, it is essential that both didactic and experiential pharmacy educators help students develop the skills needed to think critically and to use clinical reasoning to work through the complex medication-related issues presented to pharmacists.

With an increase in misinformation over the past several years, teaching students to think critically has never been more important.

Ideally, skills and abilities in thinking should be taught during didactic education and reinforced through experiential learning. Reflect on your own education and experience in pharmacy school. Were you ever given a lecture or received a course that taught you how to think? Most of us would claim that the ability to think critically was infused as a “hidden” curriculum, something that is eventually learned but may not have been taught intentionally. Perhaps now is the time to coordinate efforts and devise an approach to teach thinking skills explicitly, not to simply model or imply these skills.

The purpose of this article is to describe the importance of critical thinking for pharmacy learners and provide a framework for including critical thinking questions and concepts into Introductory (IPPE) and Advanced Pharmacy Practice Experiences (APPE). Due to their real world setting with clinical and logistical challenges, pharmacy preceptors are uniquely positioned to help pharmacy students grow in their ability to think critically and use sound clinical reasoning skills to provide patient care.

But first, a disclaimer. Neither author is an expert in neuroscience or critical thinking. We are humble pharmacists who are also preceptors, academicians, and experiential education administrators. In these roles, we strive to improve and refine our own thinking, and to foster improved thinking for our students. We have personally sought to understand and apply the critical thinking model by Paul and Elder to pharmacy practice and pharmacy precepting.1 Much of our understanding of this topic is based

on the works of Linda Elder and Richard Paul, the founders of the Foundation for Critical Thinking.1 An overview of their work can be found at www.criticalthinking.org.2

For the purposes of this article, critical thinking can be defined as the art of analyzing and evaluating the process of thinking, with a goal of improving these processes.1 It is a way of thinking that is self-directed, self-disciplined, self-monitored, and self-corrective.1 Clinical reasoning can be defined as a mental process in which a health care provider engages in analytical and non-analytical reasoning and reflection to make clinical decisions.3 In other words, clinical reasoning is critical thinking applied to patient care.

Why should pharmacy preceptors seek to improve the thinking of their students? Humans think.

Essential elements of being human are thinking, making meaning, and finding connections. We think all the time. Yet, when left to itself, thinking is flawed, biased, and self-serving. Critical thinking is a way to take charge of our own cognitive processes with a view to limit unsound thinking and expand critical thought.

The physician Ronald Epstein makes a profound statement in his book entitled Attending: Medicine, Mindfulness, and Humanity: “I’d need to be guardian of my patients’ health and also of my own ‘inner operating system’ in each moment.

Awareness of my own mind might be one of the most important tools I could have in addressing patients’ needs.” (Epstein p.3).4 As pharmacists and pharmacy preceptors, we can work on our own thinking as we simultaneously promote and stimulate critical thought in our learners, thus improving what Epstein refers to as “awareness of our own mind.” From the perspective of Paul and Elder, the critical thinking model can help us analyze, evaluate, and improve our thinking processes, which can be impactful for both preceptors and students alike.1

The Paul and Elder model is based on a framework that uses three areas to improve thinking: standards, elements, and intellectual traits.1 The standards of critical thought must be applied to the elements of critical thought as we learn to develop intellectual traits.1 The standards (Table 1), elements (Table 2), and intellectual traits (Table 3) are summarized below.

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Table 1 – The standards of critical thinking, definitions for each standard and example questions that could be used to help a learner apply each standard to their thinking.

Standards

What this means

Application questions for the learner

Clarity

Understandable; the meaning can be grasped

Can you elaborate further? Can you please give me an example?

Accuracy

Free from errors or distortions

How could we make sure this is true? Can you please provide me a reference?

Precision

Exact to the necessary level of detail

Could you be more specific? Could you give me more details?

Relevance

Relating to the matter at hand

How is this related to what we are talking about?

How will this help us solve this problem?

Depth

Containing complexities and multiple interrelationships

What makes this a difficult question? What are some of the complexities of this case?

Breadth

Encompassing multiple viewpoints

Do we need to look at this from another perspective?

Logic

The parts make sense together; no contradictions

How did you come to this conclusion? How does this all fit together?

Significance

Focusing on the important; not trivial

Is this the most important issue to consider? Which of the facts are most important?

Fairness

Justifiable; not self-serving or one-sided

Are we being fair to everyone now? Are we considering the feelings of others in this situation?

Adopted from Paul and Elder1

Table 2 – The elements of critical thinking, definitions for each element and example questions that could be used to help a learner apply each element to their thinking.

Elements

What this means

Application questions for the learner

Purpose

Goal, objective, functions

What is our purpose in doing this?

Questions

Problem or issue

What questions are we trying to answer?

Information

Data, facts, reasons, observations, experiences

What information do I need? To what extent is your reasoning supported by data?

Interpretation and inference

Conclusions, solutions

What conclusions am I coming to? Are there other conclusions that I should consider?

Concepts

Theories, definitions, laws, principles, models

What are the main ideas I am relying on in my thinking?

Assumptions

Presuppositions, axioms, taking for granted

What am I taking for granted? Am I assuming something I shouldn’t?

Implications and consequences

That which follows logically, the effects

If we do “X”, what will happen?

Point of view

Frames of reference perspective, orientations, world view

How am I looking at this situation? Is there another reasonable point of view?

Adopted from Paul and Elder1

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Table 3 – The intellectual traits of critical thinking, definitions for each trait and example questions that could be used to help a learner apply each trait to their thinking.

Intellectual Traits

What this means

Application questions for the learner

Intellectual integrity

Hold yourself to the same standards to which you hold others

To what extent are there contradictions or inconsistencies in how I handle clinical issues?

Intellectual autonomy

Value independence of thought

Do I think through clinical issues on my own or just accept conclusions and judgments of others?

Intellectual perseverance

Refuse to give up easily; work your way through complexities and frustration

How can I keep working through complex clinical issues?

Intellectual empathy

Learn to enter opposing views empathetically

Can I listen to others with opposing viewpoints and accurately represent their side of the discussion? Can I actively seek to understand others’ reasoning?

Intellectual humility

Strive to discover the extent of your ignorance

What do I really know about this issue? To what extent might my prejudices, attitude and experiences bias my judgement?

Intellectual courage

Develop the courage to change popular beliefs

How can I speak up for what I believe is right?

Confidence in reason

Respect evidence and reasoning and value them as tools for discovering truth

Am I willing to change my position when evidence leads to a more reasonable position?

Adopted from Paul and Elder1

The standards, elements, and intellectual traits of critical thought listed above make sense and provide a map that can be used to evaluate one’s own thinking or the thinking of a learner. While this framework is logical and intuitive, it can also feel overwhelming to incorporate terminology and a framework that may be unfamiliar to a preceptor. A preceptor seeking to improve thinking using the Paul and Elder framework may wonder where to begin.

One strategy that may be helpful is to print the tables used in this article and place them in a prominent setting, easily visible during precepting hours. Perhaps a bulletin board, a desktop screensaver, in a lab jacket pocket, or affixed to a clipboard could help keep the standards, elements, and intellectual traits front-of-mind and prompt questions that promote critical thought.

More specifically, preceptors could also use the standards of critical thought to help a learner take a deeper dive into a patient case, or to explore a student’s depth of understanding during a formal or informal topic discussion. A preceptor could utilize the elements of critical thought for journal club presentations, patient chart review, or the interpretation and assessment of clinical

or non-clinical data. Applying the intellectual traits of critical thought may be helpful to a preceptor as they help guide the student to develop affective abilities (such as a student’s feelings and attitudes), professional traits, the ability to evaluate social determinants of health, or assess a patient’s readiness to begin a behavior modification plan. In addition, when a preceptor is providing formative feedback to a student, instead of simply telling the student where and how they went wrong, consider instead using the questions in the tables above to help students self-assess and develop their critical thinking skills.

Consider this example. You are precepting an APPE student and you note a problem with your patient’s antibiotic order. Recognizing a learning opportunity, you ask your student to review the patient’s record and identify the problem. The student responds with recommendations for renally adjusting the patient’s antibiotic dose.

While the student correctly identified that the ordered dose was inappropriate for the patient’s renal function, you were hoping that the student would see that a more significant problem was that the patient is allergic to this antibiotic. You

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could correct the student and move on. However, time permitting, this could be an opportunity to make a lasting impression and help the student improve their thinking. You could help the student apply the standards of critical thinking to the patient’s case by asking some of the example questions. For example, to help the student consider the standard of assumptions, you could ask, “I appreciate that you noticed the patient’s impaired renal function, but it looks like you have missed something. Is this the most important problem to consider? Have we considered all of the patient’s specific factors?” Or you could help the student apply the elements of critical thinking, such as the element of assumptions, by posing questions like, “Are there other conclusions you should consider? Are you making any assumptions?” Finally, with this same example, the student could be guided to demonstrate the intellectual traits of autonomy by searching for the answer independently, or the intellectual trait of perseverance to keep working on the case until they see what they are missing.

While on a rotation, our learners encounter a significant amount of information and it is hard to know how much will be retained long term, but helping a learner think critically can be a

lasting gift that impacts every aspect of their life.

The critical thinking guidelines presented here may seem esoteric, but pharmacists should be thinking critically in every professional decision.

If the purpose of our rotation is to simply impart information, our students will be disadvantaged in a changing clinical landscape and new developments. But if we can help our students improve their thinking, their careers and lives will be impacted indefinitely. BF Skinner penned a similar sentiment with these words, “Education is what survives when what has been learned has been forgotten.”5  REFERENCES

1. Paul R and Elder L. The Miniature Guide to Critical Thinking: Concepts and Tools. London: Rowman and Littlefield; 2020.

2. Criticalthinking.org [internet]. The Foundation for Critical Thinking; [cited 2022 Feb 17]. Available from: http://www. criticalthinking.org/ 3. Newsom L, Augustine J, Funk K, Janke K. Enhancing the “What” and “Why” of the PPCP with the “How” of Clinical Reasoning. Am J Pharm Educ. Epub Aug 2021

4. Epstein R. Attending: Medicine, Mindfulness, and Humanity.

New York: Scribner; 2017.

5. Skinner BF. New Methods and New Aims in Teaching. New Scientist. 1964; 122.

For adult patients with T2D, treated with diet and exercise For adult patients with T2D, treated with diet and exercise

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Indications and Limitations of Use Important Safety Information Ozempic®and (semaglutide) injection mg or 1 mg is indicated as an adjunct to diet and exercise toImportant Indications Limitations of0.5 Use Safety Information WARNING: RISK OF THYROID C-CELL TUMORS

® improve glycemic control adults mellitus to reduce riskexercise of majortoadverse WARNING: Ozempic (semaglutide) injectionin 0.5 mgwith or 1type mg2isdiabetes indicated as an and adjunct to diettheand • In rodents, causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant RISK OFsemaglutide THYROID C-CELL TUMORS (CV)inevents infarction, nonfatal in adults with • In rodents, ® improvecardiovascular glycemic control adults (CV withdeath, type 2nonfatal diabetesmyocardial mellitus and to reduceorthe risk of stroke) major adverse exposures.

It is unknown whether Ozempic causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in semaglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant type 2 diabetes mellitus established disease. infarction, or nonfatal stroke) in adults with cardiovascular (CV) events (CV and death, nonfatal CV myocardial ® humans asunknown human relevance ofOzempic semaglutide-induced rodent C-cell tumorsmedullary has not been determined. exposures.

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• Ozempic® is not indicated for use in patients with type 1 diabetes mellitus. them of serum symptoms of thyroid tumors (eg,ultrasound a mass in the dysphagia, dyspnea, persistent hoarseness).

Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with Ozempic®.

10 SPRING 2022

Please see additional Important Safety Information throughout.

Please see additional Important Safety Information throughout.

Please see Prescribing Information, including Boxed Warning, at https://www.novo-pi.com/ozempic.pdf.

Please see Prescribing Information, including Boxed Warning, at https://www.novo-pi.com/ozempic.pdf.

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AzPA ANNUAL CONVENTION Coming Together to Advance Arizona Pharmacy ARIZONA GRAND RESORT & SPA JUNE 16-19, 2022

THURSDAY, JUNE 16TH 8:00 AM - 5:00 PM

SOUTHWESTERN STATES RESIDENCY CONFERENCE -Separate Registration Required-

12:00 PM - 1:00 PM

LUNCH | NON-ACCREDITED SYMPOSIUM

8:00 AM - 5:00 PM

5:30 PM - 7:00 PM 7:30 PM - 8:30 PM

AZPA CERTIFICATE TRAINING PROGRAMS TBD -Separate Registration RequiredAZPA BOARD OF DIRECTORS MEETING VIP/PAST PRESIDENT’S RECEPTION -Invitation Only-

FRIDAY, JUNE 17TH 7:00 AM - 7:45 AM 8:00 AM - 9:30 AM

9:30 AM - 11:00 AM

12 SPRING 2022

YOGA Nancy Costlow, PharmD Join us for a relaxing yoga session to prepare your mind and body for a weekend full of education, fun, and networking.

PHARMPAC BREAKFAST Support AzPA’s Political Action Committee and enjoy a panel discussion with influential leaders in Arizona.

GENERAL SESSION: PHARMACY LAW UPDATE Roger Morris, RPh, JD; Shaylynn Veeder, JD Learning Objectives: • Describe ramifications of recent pharmacy related court cases.

• List recent changes in Federal Pharmacy Law. • List recent changes in State Pharmacy Law. Note: This session is pending ACPE accreditation

11:10 AM - 12:10 PM

MEDICATION ASSISTED TREATMENT FOR OPIOID USE DISORDER Brenna Darling, PharmD; Christopher Edwards, PharmD, BCPS Learning Objectives: • Identify characteristics of opioid use disorder and symptoms of opioid withdrawal.

• Give examples of appropriate counseling points for patients initiating medication assisted treatment for opioid use disorder.

• Summarize requirements and regulations pertaining to the prescription and administration of buprenorphine, methadone, naltrexone, and naloxone.

Note: This session is pending ACPE accreditation

11:10 AM - 12:10 PM

A YEAR AFTER ADUCANUMAB: EMERGING THERAPIES FOR ALZHEIMER’S DEMENTIA Ariane Guthrie, PharmD, BCPS; Dawn Knudsen Gerber, Pharm.D., BCGP, FASCP, FAzPA Learning Objectives: • Define the FDA approval status for aducanumab (Aduhelm®).

• Describe the inclusion and exclusion criteria used during aducanumab phase 3 trials.

• Describe emerging therapies currently in development for the treatment of Alzheimer’s dementia.

Note: This session is pending ACPE accreditation

11:10 AM - 12:10 PM

12:15 PM - 1:00 PM 1:00 PM - 5:00 PM

1:10 PM - 2:10 PM

DEVELOPING A FRAMEWORK TO RESPOND TO SEXIST MICROAGGRESSIONS Casey Orton, PharmD Learning Objectives: • List the common subtypes of microaggressions.

• Explain the effects of sexist microaggressions on targets.

• Give examples of recommended actions when responding to sexist microaggressions.

Note: This session is pending ACPE accreditation LUNCH | NON-ACCREDITED SYMPOSIUM

MEDWISE ADVISOR™ CERTIFICATION (PART 1) Jessica DiLeo, PharmD, BCGP, BCACP, CMWA -Separate registration requiredThis certification provides clinicians in various care settings with clinical and operational training for medication risk mitigation services.

MEDICATION ASSISTED TREATMENT FOR OPIOID USE DISORDER (REPEAT SESSION) Brenna Darling, PharmD; Christopher Edwards, PharmD, BCPS Learning Objectives: • Identify characteristics of opioid use disorder and symptoms of opioid withdrawal.

• Give examples of appropriate counseling points for patients initiating medication assisted treatment for opioid use disorder.

• Summarize requirements and regulations pertaining to the prescription and administration of buprenorphine, methadone, naltrexone, and naloxone.

Note: This session is pending ACPE accreditation

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1:10 PM - 2:10 PM

FROM A-Z: CLINICAL PEARLS FOR PHARMACY PROFESSIONALS Jake Schwarz, PharmD, MBA, BCIDP, BCCCP, BCPS, FAzPA; Others TBD Learning Objectives: • Summarize clinical scenarios or “clinical pearls” that might not be widely known or published.

• Give examples of how these “clinical pearls” can be applied in various health settings.

Note: This session is pending ACPE accreditation

1:10 PM - 2:10 PM DESIGNING AND SUBMITTING A CE: A STEP-BY-STEP EXPLANATION Jimmy Stevens, PharmD Learning Objectives: • Define the term “practice gap”.

• Describe the process of writing CE objectives.

• List the various platforms to deliver a CE. Note: This session is pending ACPE accreditation 2:15 PM - 3:15 PM

GENERAL SESSION: PHARMACY EMOTIONAL INTELLIGENCE (EQ) MANAGING BURNOUT AND FINDING YOUR SWEET SPOT Juan Kinsgbury Learning Objectives: • Define EQ with other people.

• Define EQ with yourself.

Note: This session is pending ACPE accreditation

3:30 PM - 5:00 PM TRENDS IN THIRD-PARTY PAYOR AUDITS AND EFFECTIVE RESPONSE STRATEGIES Mark Boesen, PharmD, JD; Allyson Snow, JD; Mark Ziegler, PharmD Learning Objectives: • List the current trends in third-party payor auditing practices and methods to respond effectively.

• List common strategies to improve response success when responding to audits.

• Differentiate between a regulatory authority, the US Attorney’s Office, and a private-sector auditor.

• Describe the requirements for most commercial and government payors regarding documentation.

Note: This session is pending ACPE accreditation 3:30 PM - 5:00 PM PUT ON YOUR GAME FACE: AN INTERACTIVE BOARD GAME TO REVIEW PRECEPTING FUNDAMENTALS Janet Cooley, PharmD; Suzanne Larson, PharmD; Matthew Cheung, PharmD Learning Objectives: • Given a scenario, analyze situations that preceptors may encounter specific to sites, learners and preceptors.

• Apply established precepting principles to common scenarios and cases.

• Create a plan to incorporate discussed preceptor pearls to precepting scenarios encountered in practice.

Note: This session is pending ACPE accreditation

14 SPRING 2022

3:30 PM - 5:00 PM 5:15 PM - 7:15 PM

7:00 PM - 8:00 PM

8:00 PM - 10:00 PM

AzPA FOCUS GROUPS Moderator: Darren Clonts, PharmD, MBA, BCACP Learning Objectives: TBD Note: This session is pending ACPE accreditation

EXHIBIT HALL | WELCOME RECEPTION Support our Convention Sponsors and Exhibitors while you mingle and enjoy appetizers.

FRIENDS & ALUMNI MIDWESTERN UNIVERSITY RECEPTION

FAMILY GAME NIGHT Come one come all and support our Student Academies for a night of family friendly games and networking!

SATURDAY, JUNE 18TH 7:00 AM - 7:45 AM

BREAKFAST | NON-ACCREDITED SYMPOSIUM

8:00 AM - 9:00 AM

BIOSTATS 101: UNDERSTANDING THE BASICS TO IMPROVE PATIENT CARE Jake Schwarz, PharmD, MBA, BCIDP, BCCCP, BCPS, FAzPA Learning Objectives: • Identify different types of data (nominal, ordinal, interval/ratio) to determine appropriate measure of central tendency, and appropriate test for statistical significance.

• Define and evaluate odds ratio and risk ratio reported from literature.

• Interpret statistical significance based on reported odds ratios, risk ratios, or confidence intervals.

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

Note: This session is pending ACPE accreditation

8:00 AM - 4:00 PM STUDENT LEADERSHIP & LEGACY TRACK

Dawn Knudsen Gerber, Pharm.D., BCGP, FASCP, FAzPA;

CDR Kimberly Langley, PharmD, MBA, BCPS -By invitation-

8:00 AM - 9:00 AM

CONTINUOUS GLUCOSE MONITORING: A DEEPER SCAN Lisa Beckett, PharmD, BCACP, CDCES Learning Objectives: • Summarize clinical evidence supporting continuous glucose monitor use in adults with diabetes.

• Define the components of an ambulatory glucose profile created from continuous glucose monitor data.

• Review consensus guidelines on clinical targets for continuous glucose monitor data.

• Use case-based approach to assess an ambulatory glucose profile, diabetes medications, and make adjustments to reach treatment goals.

Note: This session is pending ACPE accreditation

15 azpharmacy.org

8:00 AM - 9:00 AM

9:10 AM - 10:10 AM

10:15 AM - 11:15 AM

IMMUNIZATION UPDATE Holly Van Lew, PharmD, BCPS; Sophia Galloway, PharmD, BCACP Learning Objectives: • Discuss recent updates to pneumococcal vaccine recommendations from the Advisory Committee on Immunization Practices (ACIP) and the Centers for Disease Control and Prevention (CDC), including new products and spacing guidelines.

• Identify age indications and co-morbidities that qualify candidates to receive a pneumococcal vaccine • Discuss expanded in Shingrix indications, Hepatitis B universal recommendations for individual less than 60 years of age and additional CDC vaccine updates for 2022 Note: This session is pending ACPE accreditation OPENING GENERAL SESSION - FORECASTING AND SHAPING THE FUTURE Kathleen Pawlicki, BS, MS, FASHP Learning Objectives: • Describe the methods for development of the 2022 ASHP/ASHP Foundation Pharmacy Forecast Report • List the 2022 ASHP/ASHP Foundation Pharmacy Forecast Report’s domains of focus • Discuss the recommendations from the 2022 ASHP/ASHP Foundation Pharmacy Forecast Report Note: This session is pending ACPE accreditation BECOMING A PERSON OF INFLUENCE: INCREASE YOUR LEADERSHIP AND IMPACT Yanick Hicks, PharmD Learning Objectives: TBD Note: This session is pending ACPE accreditation

10:15 AM - 11:15 AM MYTH BUSTERS (PART I): IT’S MORE THAN THE SPECTRUM OF ACTIVITY Tho Pham, PharmD; Vanthida Huang, PharmD, BSPHM, FCCP Learning Objectives: • Discuss common antibiotic myths that are seen in clinical practice.

• Describe the current literature on the appropriate duration of treatment for bacterial infections.

• Discuss important factors to consider when choosing antimicrobial treatment regimens.

• Summarize key takeaways and clinical pearls related to common infectious disease myths.

Note: This session is pending ACPE accreditation 10:15 AM - 11:15 AM

16 SPRING 2022

MANAGING ENDOMETRIOSIS ACROSS THE LIFESPAN Erin Raney, PharmD, BCPS, BC-ADM Learning Objectives: • Describe the pathophysiology of endometriosis and associated complications across the female lifespan.

• Select treatment options for endometriosis-related pelvic pain.

• Summarize treatment options for endometriosis at different life stages, including adolescence, reproduction, and menopause.

Note: This session is pending ACPE accreditation

11:15 AM - 12:15 PM

11:15 AM - 12:15 PM

11:15 AM - 12:15 PM

MYTH BUSTERS (PART II): INFECTIOUS DISEASE EDITION Andrew Vogler, PharmD; Vanthida Huang, PharmD, BSPHM, FCCP Learning Objectives: • Discuss implications of using oral therapy as compared to IV therapy for endocarditis, bacteremia, and osteomyelitis.

• Identify appropriate antimicrobials to use for patients with penicillinallergies.

• Determine when use of a bactericidal or bacteriostatic antimicrobial is most appropriate.

Note: This session is pending ACPE accreditation UTILIZING CLINICAL PHARMACY SERVICES TO CLOSE MEDICAL HEALTH PLAN GAPS IN CARE Matthew Bertsch, PharmD Learning Objectives: TBD Note: This session is pending ACPE accreditation BREAKOUT CPE-TBA

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

enjoy lunch.

2:15 PM - 3:15 PM 3:30 PM - 4:30 PM

3:30 PM - 4:30 PM

GENERAL SESSION: OPIOID CPE -TBD Speaker: TBA Learning Objectives: TBD Note: This session is pending ACPE accreditation

THE END OF AN ERA: THE DIMINISHING ROLE OF ASPIRIN IN PRIMARY PREVENTION Maura Jones, Pharm.D. BCPS Learning Objectives: • Employ the USPSTF and ACC/AHA Primary Prevention Guidelines to identify appropriate use of aspirin for primary prevention.

• Recommend appropriate strategies to reduce risk of an initial cardiovascular event based on updated guidelines.

• Determine when discontinuation of primary cardiovascular prevention strategies is appropriate.

Note: This session is pending ACPE accreditation

INNOVATION DRIVING PHARMACY TODAY Maimuna Bruce, PharmD, MBA, MS Learning Objectives: • Describe the impact of past pharmacy innovations on the advancement of the practice of pharmacy.

• Identify the ways in which new innovations can be implemented in your practice to provide better patient outcomes.

• Discuss the impact of common misconceptions surrounding the innovations in pharmacy practice today.

Note: This session is pending ACPE accreditation

17 azpharmacy.org

3:30 PM - 4:30 PM

5:30 PM - 6:30 PM 7:00 PM - 8:00 PM

8:00 PM - 9:30 PM

CLEARING UP CONFUSION AND BLEMISHES! OVER-THE-COUNTER ACNE TREATMENTS Beth Zerr, PharmD, BCACP; Bernadette Cornelison, PharmD, BCPS Learning Objectives: • Apply knowledge of acne products to a patient to select the best product based off of product and patient-specific characteristics.

• Recommend products to treat acne in patients while also preventing hyperpigmentation.

Note: This session is pending ACPE accreditation FRIENDS & ALUMNI UNIVERSITY OF ARIZONA RECEPTION

RED CARPET RECEPTION Join us for pictures and networking as we cover the Red Carpet leading up to the 2022 AzPA Awards Program!

BLACK TIE OPTIONAL AWARDS PRESENTATION Join us for a celebration of AzPA’s prestigious 2022 awardees. This event will also recognize past AzPA virtual award winners from 2020 & 2021. This evening is a not-to-be-missed event! Attendees will be dressed to impress!

SUNDAY, JUNE 19TH 7:00 AM - 7:45 AM

8:00 AM- 12:00 PM

BREAKFAST | NON-ACCREDITED SYMPOSIUM MEDWISE ADVISOR™ CERTIFICATION (PART 2) Jessica DiLeo, PharmD, BCGP, BCACP, CMWA -Separate registration requiredThis certification provides clinicians in various care settings with clinical and operational training for medication risk mitigation services.

8:00 AM- 9:30 AM ADVANCES IN PHARMACOTHERAPY KEY INFORMATION YOU NEED TO KNOW Robert Lipsy, PharmD, BCACP, FASHP, FAzPA Learning Objectives: • Identify clinically significant drug-drug interactions for the new drugs presented.

• List FDA indications for the new drugs presented.

• Identify the patients that the new drugs have shown to be effective in.

Note: This session is pending ACPE accreditation 8:00 AM- 9:30 AM

18 SPRING 2022

NAVIGATING ACUTE CARE PHARMACY PRACTICE (FROM A TO Z) FOR THE GENERALIST PHARMACIST (PART 1) Melinda Burnworth, PharmD, FASHP, FAzPA, BCPS; Vanthida Huang, PharmD, BSPHM, FCCP; Tho Pham, PharmD; Andrew Vogler, PharmD Learning Objectives: • List the most current clinical guidelines for 26 common acute care disease states.

• Describe key takeaways (clinical pearls) related to the corresponding pharmacotherapy for the common acute care disease states.

• Summarize the key role of the pharmacist in the common acute care disease states.

Note: This session is pending ACPE accreditation

9:45 AM - 10:45 AM 10:50 AM - 11:50 AM

10:50 AM - 12:20 PM

GENERAL SESSION: AZPA TOWN HALL AzPA Board of Directors Learning Objectives: TBD Note: This session is pending ACPE accreditation

HEY SUGAR, SUGAR: A GUIDE TO THE ADVANCEMENT OF CONTINUOUS GLUCOSE MONITORS AND TROUBLESHOOTING COMMON ISSUES Adrienne Waibel, PharmD; Jacob D. Northrup, PharmD, BC-ADM, CDCESD Learning Objectives: • Identify characteristics of various continuous glucose monitors including device placement, unique features, compatibility with phone apps and wear time.

• Interpret a prescription order for continuous glucose monitors and accurately dispense necessary components.

• Recommend possible solutions to patients’ frequently asked questions and issues regarding continuous glucose monitors.

Note: This session is pending ACPE accreditation

NAVIGATING ACUTE CARE PHARMACY PRACTICE (FROM A TO Z) FOR THE GENERALIST PHARMACIST (PART 2) Melinda Burnworth, PharmD, FASHP, FAzPA, BCPS; Vanthida Huang, PharmD, BSPHM, FCCP; Tho Pham, PharmD; Andrew Vogler, PharmD Learning Objectives: • List the most current clinical guidelines for 26 common acute care disease states.

• Describe key takeaways (clinical pearls) related to the corresponding pharmacotherapy for the common acute care disease states.

• Summarize the key role of the pharmacist in the common acute care disease states.

Note: This session is pending ACPE accreditation

Hotel Information Arizona Grand Resort & Spa 8000 Arizona Grand Pkwy Phoenix, AZ 85044 Special Room Rate: $154/night * Must be booked before May 16th. https://reservations.arizonagrandresort. com/110245?groupID=3310930#/ guestsandrooms

19 azpharmacy.org

continuing education

Continuing Education Information: Target Audience: pharmacists Learning Objectives: 1. Describe key similarities and distinctions between the clinical presentation of Crohn’s disease and ulcerative colitis.

2. Discuss evidencebased treatment recommendations for the management of moderate to severe Crohn’s disease and ulcerative colitis.

3. Identify the difference between the initial management of Crohn’s disease and ulcerative colitis.

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Spot the Difference:

Outlining the Key Distinctions Between Crohn’s Disease and Ulcerative Colitis with Emphasis on Evidence-Based Treatment Recommendations Lena Kan, PharmD Desert Oasis Healthcare, Palm Springs, CA Ndidi Precious Alino, PharmD, MS Banner Ocotillo Medical Center, Chandler, AZ Conflict of Interest

The authors declare that there are no conflicts of interest.

Funding

This research was not funded.

Introduction Abstract Crohn’s disease (CD) and ulcerative colitis (UC) are two of the most common chronic idiopathic inflammatory disorders of the gastrointestinal (GI) tract. CD can affect the entire GI tract and is characterized by a discontinuous pattern with skip lesions. UC is limited to the colon with a continuous pattern that originates in the rectum.

Both share similarities in clinical presentation, use of nonspecific laboratory markers for diagnosis, and treatment, which can lead to confusion on how to appropriately manage each disease state.

CD and UC share the same medication classes used for treatment, but initial therapy will vary depending on the disease state and severity of illness. The management of CD and UC has evolved, as seen by changes in the way existing treatments are used and the inclusion of additional classes into the guidelines. This article aims to highlight primary distinctions between CD and UC while providing evidence-based treatment strategies for acute illness in both disease states.

Mildly active UC, which is limited to the colon, is initially treated using oral or rectal 5-aminosalicylates. In contrast, 5-aminosalicylates are less effective in mildly active CD because of its inability to have a widespread effect within the GI tract. Corticosteroids can be used in moderate to severe UC or CD, but only recommended for short-term use in induction of remission. Anti-tumor necrosis factor (anti-TNF) agents may be useful for induction and maintenance of remission in severe cases; however, specific agents and doses vary depending on the disease state being treated.

Crohn’s disease (CD) and ulcerative colitis (UC) are two of the most common chronic idiopathic inflammatory disorders of the gastrointestinal (GI) tract.1 Both Crohn’s disease and ulcerative colitis are marked by an abnormal response by the body’s immune system and may share similar initial symptoms, such as bloody diarrhea, abdominal pain, and weight loss. The primary distinctions between the two disease states are the location within the gastrointestinal tract, pattern of illness, and response to treatment.1 Since both disease states are inflammatory GI conditions with variable severity, patients may present with a wide range of symptoms and are diagnosed based on a broad differential.

Similarities in clinical presentation and use of nonspecific laboratory markers for diagnosis can lead to confusion and impact the appropriate management of Crohn’s disease or ulcerative colitis. Due to the availability of additional therapeutic classes for treatment and changes in the way existing treatments are used, the management of these idiopathic inflammatory disorders has rapidly evolved to optimize therapy for individuals with CD or UC.2 These changes can become a challenge for providers in selecting the appropriate management strategy based on the disease state and severity of illness. The purpose of this article is to highlight the primary distinctions between CD and UC while providing evidence-based management strategies for both disease states.

Crohn’s Disease Crohn’s disease is an idiopathic inflammatory disorder of unknown etiology with genetic, immunologic, and environmental influences. Hallmark symptoms include abdominal pain, diarrhea, nausea, vomiting, and weight loss. It can affect the entire gastrointestinal tract and is characterized by a discontinuous pattern with skip lesions, which are diseased sections of bowel adjacent to uninvolved sections in the small intestine and colon. Rectal involvement is typically spared, yet perianal disease, fistulas, and strictures are relatively common in this population.1

The diagnosis of CD is established by clinical presentation, presence of inflammatory markers, and the patient’s history.

Risk factors for CD include a history of inflammatory bowel disease (IBD), chronic use of nonsteroidal antiinflammatory medications, and cigarette smoking. An elevation in nonspecific inflammatory markers are likely to be seen in a patient with CD, such as erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), fecal calprotectin, and lactoferrin. However, there are no specific laboratory markers to detect CD. The combination of a colonoscopy and imaging of the small bowel are important to detect the location and severity of illness to confirm a CD diagnosis.1

continued on next page 21 azpharmacy.org

There are similarities in the variety of medical therapies offered as treatment options for CD and UC. For instance, the first line agents used are similar, but strength and doses may vary depending on the disease state and severity of illness. In the 2018 American College of Gastroenterology guidelines on CD, therapy is stratified based on mild symptoms versus moderate to severe symptoms.3 Mild symptoms typically require less aggressive initial therapy using a step-up approach. The first line agent for mildly severe disease is oral sulfasalazine, a 5-aminosalicylate, 3-6 grams per day in divided doses. The mechanism of action of sulfasalazine is currently unknown but thought to be an oral agent acting locally within the GI tract to modulate mediators of the inflammatory response. The oral 5-aminosalicylate, mesalamine, has not consistently shown efficacy for induction of remission and should not be used to treat active CD.3

A Cochrane review of twenty studies including 2,367 patients with mild to moderately active Crohn’s disease was conducted to investigate whether 5-aminosalycylic acid derivatives induce remission or alleviate symptoms in comparison to steroids.4 Sulfasalazine was shown to be less effective than corticosteroids and inferior to combination therapy with corticosteroids (RR 0.64, 95% CI 0.47 to 0.86), with 43% of patients entering remission at 18 weeks. There was no difference between low dose mesalamine (1-2 grams per day) and placebo (RR 1.33, 95% CI 0.91 to 1.96), and no difference between high dose mesalamine (3-4 grams per day) and placebo (95% CI -46.2 to 6.7).4 In conclusion, researchers found that sulfasalazine provides modest benefit for mild-moderate disease, while mesalamine formulations were not effective for inducing remission.

Moderate to severe symptoms require more aggressive initial therapy using a top-down approach. Oral corticosteroids at doses equivalent to prednisone 40-60 mg per day serve as first line agents to alleviate signs and symptoms for the first three months of therapy. The anti-tumor necrosis factor (anti-TNF) agents, infliximab, adalimumab, or certolizumab pegol, are effective in the treatment of CD in those who inadequately responded to corticosteroid treatment.3

Ulcerative Colitis

Ulcerative colitis is a chronic immune-mediated inflammatory condition affecting the large intestine.

Common symptoms include abdominal pain, rectal bleeding, and inflamed rectum and diarrhea. In contrast to CD, UC is limited to the colon with a

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continuous pattern that originates in the rectum and progresses proximally. Unlike CD, rectal involvement is common but perianal disease, fistulas, and stricture are uncommon.1 The pattern of disease is characterized by intermittent periods of relapse and remission, but if inadequately managed it can increase the risk of dysplasia and colorectal cancer.2 The diagnosis of UC is similar to that of CD, with the use of nonspecific serology laboratory markers for inflammatory bowel disease (IBD) in addition to assessing the clinical presentation. Anemia and elevations in CRP and ESR are commonly seen and stool studies must be conducted to rule out Clostridioides difficile. To confirm a diagnosis of UC, a colonoscopy with intubation of the ileum, accompanied by biopsies must be performed unless there is a risk of perforation. Endoscopic findings include loss of vascular markings, erosions, ulcerations, or spontaneous bleeding.2

Disease severity is categorized by stool frequency or urgency, presence of blood in the stool, anemia, and degree of ESR elevation. Patients with mild flares typically have less than 4 stools per day, intermittent blood in the stool, and an ESR less than 30 mm/hr.

Moderate to severe illness is typically categorized as greater than 6 stools per day, frequent blood found in the stool, a decrease in hemoglobin (Hgb) less than 75% of normal, and an ESR greater than 30 mm/hr.2 First line treatment for mildly active UC is an oral or rectal 5-aminosalicylate, such as mesalamine or sulfasalazine, at 1-2 grams per day for induction of remission. Oral or intravenous (IV) systemic corticosteroids are used for moderate to severely active UC or for failure to induce remission with 5-aminosalicylates. Induction agents should be continued for at least 6 weeks to assess the clinical response before a corticosteroid-free maintenance regimen is established.2

In severe cases requiring hospitalization, IV corticosteroids at a dose equivalent to methylprednisolone 60mg/day should be used short term for induction of remission only.2 A systematic review of 32 studies included 1,948 adults hospitalized for acute severe UC who received IV methylprednisolone on varying doses of at least 40 mg per day. Results showed a clinical response rate of 67% with a sub-group analysis revealing there was no benefit to doses higher than methylprednisolone 60 mg per day (R2 < 0.01, p=0.98).5 The 2019 ACG guidelines on ulcerative colitis recommend infliximab 5mg/kg or cyclosporine 2-4mg/kg per day if no clinical response is observed within 3-5 days of systemic steroids. The selection of agent should be based on provider experience with

continued on next page

each drug. Cyclosporine is used less frequently due to the necessity of monitoring trough concentrations.

A randomized controlled trial of 45 patients with acute severe UC refractory to IV corticosteroids received either a single infusion of infliximab 5mg/ kg or placebo. An inadequate response to therapy was defined as the need for a colectomy at 3 months.

The study showed a 71% response rate in those treated with infliximab, as they did not require a colectomy at 3 months (p=0.0017), indicating that infliximab is an effective and safe rescue therapy in this population.6

Conclusion

Crohn’s disease and ulcerative colitis share a similar initial presentation, and both use nonspecific serological IBD laboratory markers for diagnosis, making it difficult for providers to distinguish between varying gastrointestinal disease states. Once diagnosed with CD or UC, initial treatment is guided by the severity of disease, but is slightly variable in each. Oral sulfasalazine, a 5-aminosalicylate, is recommended as first line therapy for mildly active CD as it has been proven to have a modest benefit in this population, whereas mesalamine has shown ineffectiveness. In contrast, either oral/rectal sulfasalazine or mesalamine can be used as first line therapy in mildly active UC. Oral or IV systemic corticosteroids can be used for moderate to severe active disease in both CD and UC but should only be used as short-term therapy during induction of remission. The 2019 ACG guidelines recommend treatment with an anti-TNF agent, such as infliximab, if no clinical response is seen with corticosteroids in both disease states.  REFERENCES 1. Cheifetz, A. Management of active Crohn Disease. JAMA. 2013;309(20): 2150-2158.

2. Rubin D, Ananthakrishnan A, Siegel C, et al. ACG clinical guideline: ulcerative colitis in adults. Am J Gastroenterol.

2019;114(3): 384-413.

3. Lichtenstein G, Loftus E, Isaacs K, et al. ACG clinical guideline: management of Crohn’s disease in adults. Am J Gastroenterol. 2018;113(4): 481-517.

4. Lim W, Wang Y, MacDonald J, Hanauer S. Aminosalicylates for induction of remission or response in Crohn’s disease.

Cochrane Database. 2016.

5. Turner D, Walsh C, Steinhart H, Griffiths A. Response to corticosteroids in severe ulcerative colitis: a systematic review of the literature and a meta-regression. Clin Gastroenterol Hepatol. 2007;5(1): 103-10.

6. Jarnerot G, Hertervig E, Friis-Liby I, et al. Infliximab as rescue therapy in severe to moderately severe ulcerative colitis: a randomized, placebo-controlled study.

Gastroenterology. 2005;128(7): 1805-11.

CE Questions 1. According to the 2019 American College of Gastroenterology guidelines on ulcerative colitis in adults, which of the following medication class is considered first line treatment for a moderate-severe acute flare? a. 5-aminosalicylic acid derivatives b. Thiopurines

c. Corticosteroids

d. Anti-TNF inhibitors

2. True or False: In Crohn’s Disease, corticosteroids can be effectively used to both induce and maintain remission.

3. How long must an induction agent be used before switching to maintenance treatment in ulcerative colitis? a. ≥ 3 weeks

b. ≥ 6 weeks

c. ≥ 3 months

d. ≥ 6 months

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

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

Accredited Date: 4/8/2022 Expiration Date: 4/8/2025

This program provides for 0.5 contact hours of continuing education credit.

Universal Activity Number (UAN) is 0100-0000-22-013-H01-P Apply for credit here: https://www. lecturepanda.com/r/AJPSpring22

23 azpharmacy.org

editorial

Arizona and COVID-19: Two-Year Experience 2020-21 Howard J Eng, Mel and Enid Zuckerman College of Public Health, College of Pharmacy, University of Arizona.

Conflict of Interest

The author has no conflicts of interest.

Funding

This research was not funded.

Citation:

Howard J Eng (2022) Arizona and COVID-19: Two-Year Experience 2020-21. Journal of Medical & Clinical Research 7(2):05-10.

Reprinted with permission from author.

continued on next page 24 SPRING 2022

Abstract It had been more than two-years since COVID-19 appeared in the world.

The first case recorded in Arizona was on January 22, 2020. There had been three Arizona Reopening Phases.

During Arizona’s Reopening Phase 2 winter surge in 2020, ABC and NBC News reported that the state has the highest new cases per capital in the world. Arizona is the sixth largest in size of the United States 50 states.

It is about the same size as Italy. The study examined the first two-years of the state’s COVID-19 pandemic. There were 1,381,488 COVID-19 cases, 91,523 hospitalizations, 24,229 deaths, and 9,826,846 vaccine doses administered at the end of the second year (December 31, 2021). The state COVID-19 cases in 2021 were higher than in 2020.

The second half of 2021 had higher case numbers than the first half, but it had lower hospitalization and death numbers. The lower numbers in the second half were primarily due to the use of COVID-19 vaccines and therapeutics.

Introduction In December 2019, COVID-19 first appears in Wuhan, China.

Johns Hopkins University1 reports that there are 287,911,124 total cases and 5,435,753 deaths associated with the virus in the world on December 31, 2021. The United States has the highest total cases (54,570,527) and deaths (825,536) in the world.1 COVID-19 (coronavirus) is a respiratory disease (attacks primarily the lungs) that spreads by person to person through respiratory droplets (coughs, sneezes, and talks) and contaminated surfaces or objects.

The world combats the virus by encouraging the public to practice health behaviors that reduces the risks of getting respiratory infections (e.g., coronavirus, flu, and cold), and using vaccines and therapeutics. The preventive health behaviors include, but not limited to, practicing physical and social distancing, washing hands frequently and thoroughly, and wearing face masks. Johns Hopkins reports that more than 9.14 billion vaccine doses have been administered in the world (December 31, 2021).1 The United States (U.S.) is ranked third in the world in vaccine doses administered following China and India.1

Of the U.S. 50 states, Arizona is the sixth largest in size (113,990 square miles/295,233 square kilometers).2 It is about the same size as Italy (301,340 square kilometer).3 The state population estimate is 7,276,316 on July 1, 2021.4 Arizona is ranked 13th in total COVID-19 cases (1,373,767) and 11th in total deaths (24,212) of the 50 U.S. states on December 31, 2021.1 There has been three Arizona Reopening Phases. During Arizona’s Reopening Phase 2 winter surge in 2020, ABC and NBC News report that the state has the highest new cases per capital in the world.5,6 The United States requires a partnership between the federal government and each of the 50 states to address the COVID-19 pandemic.7 The federal government provides the national guidance and needed logistical support (e.g., provide federal supplemental funding, needed medical personnel and resources, and other needed assistance), while the states decide on what actions to take and when to carry out those actions; the state COVID-19 restrictions; and when to carry out each reopening phase; and the state vaccination plan.

The first COVID-19 recorded in Arizona was on January 22, 2020. On March 11, the World Health Organization had declared COVID-19 outbreak a pandemic.8 Soon after, the United States declared the COVID-19 pandemic as a national emergency on March 13.9 Arizona Governor Douglas Ducey issued a Stayat-Home Executive Order on March 30 (196 cases) that was in effect from March 31 to April 30.7 Arizona residents had to stay at home except for going out for essential services (e.g., grocery stores, pharmacies, doctor offices, gas stations) and working at approved essential service settings, and practiced preventive health behaviors.

continued on next page 25 azpharmacy.org

Significant Arizona COVID-19 dates are listed below • April 29 (393 cases): the Governor extended his Stay-at-Home Executive Order until May 15.

• May 12 (488 cases): the Governor confirmed that his Stay-at-Home Executive Order would end on May 15, and May 16 began Reopening Phase 1.

• June 26 (5,759 cases): the summer 2020 surge peaked [10].

• June 29 (5,486 cases): the Governor issued a new Executive Order that would address the COVID-19 outbreaks that closed bars, gyms, and theaters and prohibited large gathering until July 27. July 23 (1,743 cases): the Governor extended his June 29 Executive Order for another 2 weeks until August 10 and would review at that time whether to extend it for another two weeks.

• August 10 (921 cases): the Governor began Reopening Phase 2 laid out his plans for easing the next COVID-19 restriction phase, and established reopening health benchmarks (e.g., for bars, gyms, and schools).7 • January 4, 2021 (12,402 cases): the winter 2020 surge peaked.

• March 5 (805 cases): the Governor began Reopening Phase 3 after the state had administered more than two million vaccine doses and several weeks of declining cases, and the next phase of easing of COVID-19 restrictions.10 • August 16 (4,040 cases): the summer 2021 surge peaked.

• November 29 (5,618 cases): the fall 2021 surge peaked.

• December 30 (10,068 cases): the winter 2021 high.

• December 31 (7,099 cases): daily case number end of second year.

To get back to normal, the state needed to reach high enough population immunity to reduce the case numbers to manageable levels. Arizona had an aggressive statewide vaccination plan.

The largest weekly numbers of fully vaccinated persons occurred during April 17 to 23, 2021 (249,755).11 Therapeutics kept the numbers of

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hospitalizations and deaths low. The Delta variant surged in July-September then small dip and surged again in October-November. In December, Omicron variant appeared in the state and surged.

The study examined the first two-years of the COVID-19 pandemic (January 1, 2020 to December 31, 2021) looking at changes in the number new COVID-19 cases, hospitalizations, and deaths.

Methods

This was a two-year longitudinal study. It examined the changes in the numbers of new COVID-19 cases, hospitalized cases, deaths, and vaccines given. The data source for the study was from the Arizona Department of Health Services (the state health department) COVID-19 dashboard database.

There were several data limitations. The COVID-19 case numbers represented the numbers of positive tests reported. When more than one test given to the same person (e.g., during hospitalization, at work, and mandatory testing), there were individual case duplications. Aggressive testing resulted in increases in false positive and false negative testing results. There were delays in the data submitted daily to the state health department that affected the timeliness of data reported and caused fluctuations in the number of cases, hospitalizations, deaths, and vaccinations. The state health department continued to adjust the reported numbers that may take more than a month to correct the numbers. The deaths associated with the coronavirus may be caused by more than one serious underlying medical conditions, and the virus may not be the primary cause of death.

Results

At the end of the second year of the COVID-19 pandemic (December 31, 2021), there were 1,381,488 COVID-19 cases, 91,523 case hospitalizations, 24,229 deaths associated with the virus, and 9,826,846 vaccine doses administered in Arizona (see Table 1). In 2021, there were more cases, hospitalizations, deaths, and vaccine doses administered than 2020. Even though the second half of 2021 had more cases than first half, the number of hospitalizations and deaths were fewer in the second half of year than the first half.

continued on next page

Table 1: Arizona Total Numbers of COVID-19 Cases, Hospitalizations, Deaths, and Vaccine Administered: 2020 and 2021.

Time Period

Cases

Hospitalizations

Deaths

Vaccinations

January 1 to June 30, 2020

79,894

4,989

1,653

NA

July 1 to December 31, 2020

462,759

33,167

7,422

95,160

January 1 to December 31, 2020

542,653

38,156

9,075

95,160

January 1 to June 30, 2021

352,323

27,477

8,874

6,356,233

July 1 to December 31, 2021

486,512

25,890

6,350

3,375,453

January 1 to December 31, 2021

838,835

53,367

15,224

9,731,686

January 1, 2020 to December 31, 2021

1,381,488

91,523

24,229

9,826,846

Source: Arizona Department of Health Services COVID-19 Dashboard. Arizona 2020 population is 7,151,502, April 1, 2020 and Arizona 2021 population estimate is 7,276,316, July 1, 2021-U.S. Census.

A case could be mild (no symptoms), moderate (sick, but can recover at home), and severe (require hospitalization and/or result in death).

Most people recovered and did not require hospitalization. There were five case surges during the two-year period: two summers, one fall, and two winters (see Figure 1). Unlike 2020 summer and winter surges, there was no significant decline in cases during the 2001 summer, fall, and winter surges.

Figure 2: Arizona COVID-19 Cases by Age Groups for 2020, 2021, and Two-Year Total.

Figure 1: Arizona COVID-19 Daily Cases: January 1, 2020 to December 31, 2021

Figure 3: Arizona COVID-19 Daily Case Hospitalizations: January 1, 2020 to December 31, 2021.

There were larger case numbers in 2021 (838,835) than in 2020 (542,653). The increases occurred in all five age groups (see Figure 2). The two age groups that had the largest case increases were 20-44 years (131,765) and younger than 20 years (116,075). There were more females (52%) than males (48%) who got the virus. The two largest state race/ethnicity groups diagnosed with COVID-19 were White, non-Hispanics (40%) and Hispanics (29%).

As expected, seniors had the highest percentage of the total hospitalizations (42.3%) and those under 20 years of age had the lowest percentage (3.7%) on December 31, 2021. Twentythree percent (23.1%) of seniors diagnosed with COVID-19 were hospitalized, while 1.2 percent of those under 20

continued on next page 27 azpharmacy.org

years of age were hospitalized. There were more males (52.5%) than females (47.5%) who were hospitalized.

The second half of 2021 (25,890) had lower hospitalization numbers than first half of the year (27,477) most of the hospitalizations occurred in the beginning of 2021. The decrease hospitalizations in the second half of 2021 was due to the decrease hospitalization percentages of three age groups: less than 20 years (2.06% to 0.79%), 20 to 44 years (3.50% to 3.16%), and 65 years and older (25.26% to 19.25%). Figure 4 shows the hospitalization numbers for each age group in 2020, 2021, and two-year total.

Figure 4: Arizona COVID-19 Case Hospitalizations by Age Groups for 2020, 2021, and Two-Year Total.

In 2021, the total death numbers were higher than 2020 (15,224 and 9,075 respectively).

Figure 5 shows Arizona daily deaths.

Figure 5: Arizona COVID-19 Daily Deaths: January 1, 2020 to December 31, 2021.

On December 31, 2021, seniors had the highest percentage of total deaths (70.7%) and those under 20 years of age had the lowest percentage (0.2%). Ten percent (10.2%) of the seniors diagnosed with COVID-19 died, while 0.02 percent of those under 20 years of age died. There were more males (59%) than females (41%) who died. The rate of fatalities per 100,000 population was 337.0.

The second half of 2021 (6,350) had lower death numbers than first half (8,874) most of the deaths occurred at the beginning of the

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year. The decrease deaths in the second half of 2021 was due to the decrease death percentages of three age groups: less than 20 years (0.025% to 0.016%), 55 to 64 years (2.83% to 2.55%), and 65 years and older (13.22% to 7.42%). Figure 6 shows the death numbers for each age group in 2020, 2021, and twoyear total.

Figure 6: Arizona COVID-19 Deaths by Age Groups for 2020, 2021, and Two-Year Total.

The first U.S. COVID-19 vaccine, Pfizer/BioNTech, was approved for use on December 11, 2020.

Arizona began to administer vaccines in late December. Three vaccines were available in Arizona (Pfizer/BioNTech, Moderna, and Johnson & Johnson). The vaccines provided different levels of protection against COVID-19 and its variants.

On January 8, 2021, the Arizona Department of Health Services reported 126,090 vaccine doses were administered and 124,322 who were partial protected against COVID-19. This had grown to 9,826,846 vaccine doses were administered and 3,955,021 who were fully vaccinated against the virus on December 31, 2021.The vaccination percentages of those who had received at least one dose by five age groups were less than 20 years 28.4%; 20-44 years - 61.0%; 45-54 years - 69.9%; 55-64 years - 76.9%; and 65 years and older 93.5%.

Figure 7 shows the numbers of COVID-19 vaccines that were given in Arizona (total doses given, persons receiving at least one dose, and persons fully vaccinated) during 2021.

Figure 7: Arizona COVID-19 Vaccination Numbers: February 19 to December 31, 2021*.

continued on next page

Discussion During most of the first year (2020) of the COVID-19 pandemic, there were no approved U.S. drug to treat the virus or vaccine. On October 22, 2020, the Food and Drug Administration (FDA) approved the first drug, Remdesivir for the treatment of COVID-19. The first U.S. vaccine (Pfizer-BioNTech) was approved for use on December 11. Without vaccines and therapeutics, the primary strategies in 2020 to confront the virus were to encourages the public to practice preventive health behaviors that reduces the risks of getting respiratory infections (e.g., coronavirus, flu, and cold) and stay-at-home. For those who have or have been exposed to the virus had to be quarantined.

On March 13, 2020, the United States declared COVID-19 a pandemic.9 The Centers for Disease Control and Prevention (CDC) provided guidance to the states (e.g., on preventionstrategies, state reopening guidelines, and vaccine priorities).

Arizona Governor Douglas Ducey issued a Stayat-Home Executive Order on March 30.7 State residents had to stay at home except for going out for essential services or going to work at approved essential jobs. The state encouraged the practicing of preventive health behaviors that included, but not limited to, social distancing, frequent hand washing, clean and disinfect potential contaminated surfaces or objects, and avoid crowds. The Executive Order was successful in keeping the COVID-19 cases low. On May 16, Arizona began its Reopening Phase 1.

After six weeks of reopening the state, the COVID-19 cases spiked. The factors that contributed to the case increases included the easing of restrictions, the aggressive COVID-19 testing, significant numbers of people did not adhere to social distancing and preventive health recommendations, and large crowd events. On June 29, Governor Ducey issued a new Executive Order that addressed the COVID-19 outbreaks (e.g., delayed opening of some businesses, closed bars, gyms and theaters, limit business occupancy numbers, and prohibited large gathering).10 The state continued to encourage the practice of preventive health behaviors and staying-at-home.

As the result of the aggressive state actions that lead to the decline of COVID-19 cases, the Governor began Reopening Phase 2 on August 10.10 The cases remained low until the first week of November when the cases rose and continued

rising into 2020-21 winter. During the case surge, the state did not issue any new COVID-19 restrictions, but stopped the easing of existing restrictions. Some counties issued their own new restrictions (e.g.,Pima County implemented 10:00 p.m. to 5:00 a.m. voluntary/mandatory curfews).

In the second year (2021), Arizona used a threepronged attack against the virus: (1) encourage preventive health behaviors, (2) increase vaccination numbers, and (3) use therapeutics. As more people were vaccinated and those infected recovered and have immunity against the virus; the numbers of cases, hospitalizations, and deaths would be low; COVID-19 would be manageable; and the state would be able to return to normal.

At the end of December 2020, Arizona began to administer the COVID-19 vaccines. On January 4, 2021, the winter surge peaked at 12,402 new cases. ABC and NBC News reported that Arizona has the highest new cases per capital in the world.5,6 Soon after, the cases began to decline. On March 5, 2021, the Arizona Governor began Reopening Phase 3 after the state had administered more than two million vaccine doses and several weeks of declining cases.10

During the Reopening Phase 3, Arizona continued its efforts to vaccinate its population. The largest numbers of fully vaccinated persons occurred during the week of April 17 to23 (249,755).11 The pace of vaccination began to slow down in June. Arizona case numbers had decreased in the spring and early summer. At the end of June, the Arizona State Legislature and Governor had rescinded many of the state COVID-19 restrictions.

During the month of July, the highly contagious Delta variant appeared in the state and began the summer surge.

The state and locate health departments increased their vaccination efforts as the Delta variant rose. The number of vaccination sites expanded throughout the state that included pharmacy chains, doctor offices, and community centers and clinics. The state targeted vaccination efforts to hard-to-reach minority and rural communities.

The local governments, schools and universities, and private employers acted on their own to address the virus increases.

Even with the increase vaccination efforts and other actions, they were not enough to stop the Delta variant. The easing of the COVID-19 restrictions (e.g., those working at home returning to their workplaces, children and college students

continued on next page 29 azpharmacy.org

returning to in person classroom learning, and fans attending sport and entertainment events) made it easier for the virus to spread.

This resulted in the fall surge. In December, the Omicron variant appeared in the state and began to surge.

The three vaccines and therapeutics kept the number of hospitalizations and deaths low. Even with the occasion case surges, the state normal were low number of severe cases, manageable hospitalization numbers, and very low number of deaths.

Conclusion

At the end of the second year of the COVID-19 pandemic, there were 1,381,488 cases, 91,523 hospitalizations, 24,229 deaths, and 9,826,846 vaccine doses administered in Arizona. The state cases in 2021 were higher than in 2020. The second half of 2021 had higher case numbers than the first half, but it had lower hospitalization and death numbers. The low numbers were primary due to the high numbers of high-risk individuals and elderly had been vaccinated and the availability of drugs for treating the virus.  REFERENCES 1. 1. Johns Hopkins University Coronavirus Resource Center, https://coronavirus.jhu.edu/.

2. Britannica, Arizona state, United States, https://www. britannica.com/place/Arizona-state.

3. My Life Elsewhere, Arizona is around the same size as Italy, https://www.mylifeelsewhere.com/country-sizecomparison/arizona-usa/italy.

4. United States Census Bureau, Quick Facts, https://www. census.gov/quickfacts/AZ.

5. Deliso, Meredith. “Arizona ‘hottest hot spot’ for COVID-19 as health officials warn of hospital strain: The state has the highest infections per capita globally, based on JHU data, ABC News, January 7, 2021, https://abcnews.go.com/ US/arizona-hottesthot-spot-covid-19-health-officials/ story?id=75062175.

6. Chow, Denise and Joe Murphy. These three states have the worst Covid infection rates of anywhere in the world: Arizona currently has the highest per capita rate of new Covid-19 infections, with 785 cases per 100,000 people over the past seven days, followed closely by California and Rhode Island, NBC News, January 5, 2021 and updated on January 7, 2021, https://www.nbcnews.com/science/ science-news/thesethree-states-have-worst-covid infectionrates-anywhereworld-n1252861.

7. Eng Howard J (2020) Arizona and COVID-19. Med Clin Res 5(8):175-178.

8. Time, World Health Organization Declares COVID-19 a ‘Pandemic.’ Here’s What That Means, March 11, 2020, https://time.com/5791661/who-coronavirus-pandemicdeclaration/.

9. White House, Proclamation on Declaring a National Emergency Concerning the Novel Coronavirus Disease Med Clin Res, 2022 www.opastonline.com Volume 7 | Issue 2 | 10 Copyright: ©2022: Howard J Eng. This is an openaccess article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. (COVID-19) Outbreak, March 13, 2020, https://www.whitehouse.gov/ presidential-actions/proclamation-declaringnationalemergency-concerning-novel-coronavirus-diseasecovid-19outbreak/.

10. Eng Howard J (2021) Arizona Reopening Phase 2: Rise and Fall of COVID-19 Cases,” Med Clin Res 6(4):114-118.

11. Eng Howard J (2021) Arizona Reopening Phase 3 and COVID-19: Returning to Normal. Med Clin Res 6(9):687-691.

AzPA presents an innovative podcast intended for pharmacists and pharmacy technicians to obtain continuing education credit. The podcast also provides current health www.azpharmacy.org/education/azpa-podcast/

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editorial new s

University & Alumni News Creighton University School of Pharmacy Amy Wilson, PharmD

Interim Dean, Creighton University SOP

Creighton Opens Health Sciences Campus in Midtown Phoenix education that Creighton offers will provide the people of Arizona, and the health care systems, access to competent, compassionate professionals to meet the needs of the growing Phoenix landscape,” Wilson says.

The Creighton University Health Sciences Campus – Phoenix opened its doors in August 2021, welcoming students across multiple health science disciplines. The seven-story, 195,000-square-foot building is home to future pharmacists, as well as occupational therapists, nurses, and doctors. In fall 2022, the campus will welcome its first class of physical therapists, and the physician assistant program will begin in fall 2023.

With this new campus, Creighton becomes the largest Catholic health professions educator in the country.

Amy Friedman Wilson, PharmD, interim dean of the Creighton University School of Pharmacy and Health Professions, says the campus presents an opportunity for Creighton health sciences to have a positive impact on the Phoenix health care market.

“The portfolio of high-quality health care

The Phoenix pharmacy pathway offers students a low residency approach to learning in which they are on campus for hands-on, abilities and lab-based learning with the didactic portion taught online.

Creighton was the first university in the U.S. to offer an online Doctor of Pharmacy program, and since the program launched in 2001, has remained on the leading edge of distance pharmacy education. Pharmacy students in Phoenix will benefit from this innovative learning technology.

PharmD students also have access to numerous opportunities to get involved, locally and globally, with health promotion initiatives and scholarly presentations, publications and grant acquisitions.

31 azpharmacy.org

Rick G. Schnellmann, PhD

Dean, University of Arizona COP—Tucson

R. Ken Coit College of Pharmacy Climbs to No. 6 in Blue Ridge Rankings of NIH Funding The University of Arizona Health Sciences received more than $133 million in National Institutes of Health (NIH) funding in 2020–2021, with several colleges showing improvements in the Blue Ridge Institute for Medical Research national rankings, released in mid-February.

The Blue Ridge Institute for Medical Research is a nonprofit organization that ranks U.S. medical schools

by NIH grant awards each year. The NIH is the largest public funder of biomedical research in the world.

NIH-funded research has led to breakthroughs and new treatments helping people live longer, healthier lives, and building the research foundation that drives discovery.

From Oct. 1, 2020, to Sept. 30, 2021, the UArizona R. Ken Coit College of Pharmacy advanced its ranking to No. 6 with $13.8 million in NIH funding. Last year, the college checked in at No. 8 with $10 million in funding.

Some of the Coit College of Pharmacy’s largest NIH grants were received by Jeannie Lee, PharmD, BCPS, BCGP, FASHP, assistant dean for student services and associate professor whose NIH-funded projects are focused on improving hypertension medication

“Our project is focused on developing and testing a digital therapeutic intervention to improve hypertension medication adherence for older adults.” Jeannie Lee, PharmD

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adherence in older adults, Hongmin Li, PhD, who holds the R. Ken and Donna Coit Endowed Chair in Drug Discovery and is working to identify new therapeutic targets for several diseases including those caused by flaviviruses, including West Nile, Zika and yellow fever, and Haining Zhu, PhD, who holds the R. Ken and Donna Coit Endowed Chair in Aging and Neurodegenerative Disease, is working to better understand the molecular mechanisms for neurodegenerative diseases including amyotrophic lateral sclerosis (ALS) and frontotemporal dementia (FTD) and other diseases such as cancer.

“Hypertension is the most prevalent chronic disease among older Americans,” said Dr. Lee. “While medications are remarkably effective in reducing negative outcomes of uncontrolled hypertension, medication adherence rate is only about 50% with hypertension control in older adults only around 53%. Proper adherence to hypertension medications can yield major reductions in heart failure and stroke, and preserve cognitive function. Our project is focused on developing and testing a digital therapeutic intervention to improve hypertension medication adherence for older adults.” 

continued on page 35

Midwestern University College of Pharmacy Mitchell R. Emerson, PhD

Dean, Midwestern University CPG

Greetings from the Midwestern University College of Pharmacy. 2022 is starting off busy, but our faculty and students continue to shine.

We’re embracing the moments of normalcy and are happy to share that in late January we hosted our first in-person College of Pharmacy Alumni and Student mentoring reception. Alumni from various backgrounds and a variety of class years joined current students on campus and shared an evening of mentoring and networking. Being able to safely bring our community together was extremely meaningful to everyone. We’re looking to the future and looking forward to hosting additional events.

In June, the program will welcome the newest class of Pharmacy students, the class of 2025.

We’re looking forward to welcoming them with open arms and get their journey started.

Also in June, please stop by the Midwestern University Alumni and Friends Dessert Reception. This event will be the first time in two year’s we’ve hosted at the AZPA Annual Convention. The event is being planned for Friday, June 17th. As always, we’ll have plenty of sweet treats and plenty of time to catch up with everyone.

In April, Dr. Suzanne Larson, Midwestern University and Dr. Janet Cooley, The University of Arizona will join together and host a Continued Education program where attendees will receive one free hour of CE. The duo will share ideas about technology on rotations- tools for both in person and remote learning. If you’re interested in more details, please reach out to Kimberly Hastings, Manager of Alumni Relations for Midwestern University at KHastings@midwestern.edu

We are looking forward to catching up with all of you and connecting at a future event.

To follow us and learn more about our events and wins, join the CPG social media community: Like us on Facebook: MWUpharmacy

Follow us on Twitter: MWUpharmacy and Instagram: MWUpharmacy 

33 azpharmacy.org

editorial rx and t h e l a w

Rx and the Law: Emergency Use Authorizations Don R. McGuire Jr. R.Ph., J.D. This series, Pharmacy and the Law, is presented by Pharmacists Mutual Insurance Company and your State Pharmacy Association through Pharmacy Marketing Group, Inc., a company dedicated to providing quality products and services to the pharmacy community.

There have been a number of questions from pharmacists about the potential liability of administering COVID vaccines available under an Emergency Use Authorization (EUA) and how that status may impact their insurance coverage. What is the difference between an approved drug and one available under an EUA? An EUA may be approved by the Food and Drug Administration (FDA) to help make medical countermeasures available for use during public health emergencies. To be approved for an EUA, there must be no adequate, approved, and available alternative. At the beginning of the

34 SPRING 2022

pandemic in early 2020, this was true. To apply for an EUA, the manufacturer must complete three phases of investigations.

Phase 1 uses the vaccine on a small population of healthy patients. Phase 2 expands the number of patients in the trial to hundreds and includes a wider range of demographics and health statuses.

Phase 3 expands to thousands of patients with broad demographic groups. This phase collects critical information on safety and effectiveness.

By this point, tens of thousands of patients have been administered the vaccine (or a control) and monitored.

Prior to submission to FDA, the manufacturer of the vaccine will submit their data to an independent Data Safety Monitoring Board for review. After submission, the data is also reviewed by the Vaccine and Related Biological Products Advisory Committee. Failure to receive high marks from either of these groups will likely lead to a denial of the EUA application.

Three vaccines were authorized under separate EUA applications in late 2020 and early 2021.

The EUA makes it legal to administer the vaccines in the United States. Most insurance policies for pharmacy professional liability contain an exclusion for acts in violation of pharmacy laws.

Because these vaccines are legal for use under the EUA, this exclusion would not apply. Review your policy for any general vaccine exclusion or a specific COVID vaccine exclusion. Also review the policy language for any provision addressing the use of only approved drugs. Absent these, your policy should cover the administration of COVID vaccines under an EUA.

This issue is slowly going away for COVID vaccines because FDA has now granted full approval for two vaccines, the Pfizer-BioNTech vaccine on August 23, 2021 and the Moderna vaccine on January 31, 2022. To gain full approval, the manufacturer gathers additional safety and effectiveness data through continuing trials and monitoring of patients. Clinically, there is little difference between a product used under an EUA and one that has been fully approved. However, any “approved” language in your policy could be problematic for insurance coverage.

Because there is little difference clinically, administration of COVID vaccines should be

treated in a similar manner to other vaccines administered in the pharmacy. Use of a specific patient waiver beyond the normal consent form to try to avoid potential liability is not necessary and not likely to be legally enforceable. The professional responsibilities of the pharmacist under statutes and regulations were created to protect patients. Those responsibilities are placed on the pharmacist because of their education and experience. If the idea of a waiver or release like this was viable, every professional would use one with every transaction or encounter. Make sure to provide the required patient information and counsel the patient on important points as you would for any other vaccine.

Legally, the administration or dispensing of a drug under an EUA is every bit as valid as administering or dispensing an approved drug. There is a difference however. When the public health emergency ends, the EUA is also extinguished.

When that day comes, the two approved vaccines can continue to be used, but vaccines authorized under an EUA will not be legal to use in the United States any longer. Insurance coverage for administering vaccines under an EUA is likely included in your policy, but a quick review of your insurance policy should be able to verify that for you.  © 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.

University & Alumni News continued from page 32 “The rise in our NIH funding is a testament to the ground-breaking research we do at the R. Ken Coit College of Pharmacy,” said Dean Rick G. Schnellmann, PhD. “Our NIH funding enables us to find ways to improve economic, clinical, and humanistic outcomes associated with managing chronic conditions, to advance drug discovery and delivery, determine mechanisms of action of pharmaceuticals, and define adverse

effects of drugs, industrial chemicals and environmental pollutants.”

The Blue Ridge rankings are determined by the whole value of NIH awards to a principal investigator’s institution and do not include research and development contracts or funding from sources other than the NIH.

A version of this article originally appeared on the UArizona Health Sciences website. 

35 azpharmacy.org

editorial f inanc i a l for u m

College Funding Choices Explore the different ways you can help finance the costs of higher education.

Pat Reding and Bo Schnurr

This series, Financial Forum, is presented by PRISM Wealth Advisors, LLC and your State Pharmacy Association through Pharmacy Marketing Group, Inc., a company dedicated to providing quality products and services to the pharmacy community.

How can you help cover your child’s future college costs? Saving early (and often) may be key for most families. Here are some college savings vehicles to consider.

529 College Savings Plans

Offered by states and some educational institutions, these plans allow you to save up to $15,000 per year for your child’s college costs

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without having to file an I.R.S. gift tax return. A married couple can contribute up to $30,000 per year. However, an individual or couple’s annual contribution to a 529 plan cannot exceed the yearly gift tax exclusion set by the Internal Revenue Service. You may be able to frontload a 529 plan with up to $75,000 in initial contributions per plan beneficiary—up to five years of gifts in one year—without triggering gift taxes.1,2 Remember, a 529 plan is a college savings

continued on next page

Imagine your child graduating from college, debt-free. With the right kind of college planning, that may happen. Talk to a financial professional today about these savings methods and others.

play that allows individuals to save for college on a tax-advantaged basis. State tax treatment of 529 plans is only one factor to consider prior to committing to a savings plan. Also, consider the fees and expenses associated with the particular plan. Whether a state tax deduction is available will depend on your state of residence. State tax laws and treatment may vary. State tax laws may be different than federal tax laws. Earnings on non-qualified distributions will be subject to income tax and a 10% federal penalty tax.

If your child doesn’t want to go to college, you can change the beneficiary to another child in your family. You can even roll over distributions from a 529 plan into another 529 plan established for the same beneficiary (or another family member) without tax consequences.1,2 Grandparents can also start a 529 plan or other college savings vehicle. In fact, anyone can set up a 529 plan on behalf of anyone. You can even establish one for yourself.1,2

Coverdell ESAs

Single filers with modified adjusted gross incomes (MAGIs) of $95,000 or less and joint filers with MAGIs of $190,000 or less can pour up to $2,000 into these accounts annually. If your income is higher than that, phaseouts apply above those MAGI levels. Money saved and invested in a Coverdell ESA can be used for college or K-12 education expenses.3

Contributions to Coverdell ESAs aren’t taxdeductible, but the accounts enjoy tax-deferred growth, and withdrawals are tax-free, so long as

they are used for qualified education expenses.

Contributions may be made until the account beneficiary turns 18. The money must be withdrawn when the beneficiary turns 30, or taxes and penalties may occur.3,4

UGMA & UTMA Accounts These all-purpose savings and investment accounts are often used to save for college. They take the form of a trust. When you put money in the trust, you are making an irrevocable gift to your child. You manage the trust assets until your child reaches the age when the trust terminates (i.e., adulthood). At that point, your child can use the UGMA or UTMA funds to pay for college; however, once that age is reached, your child can also use the money to pay for anything else.5 Using a trust involves a complex set of tax rules and regulations. Before moving forward with a trust, consider working with a professional who is familiar with the rules and regulations.

Imagine your child graduating from college, debtfree. With the right kind of college planning, that may happen. Talk to a financial professional today about these savings methods and others.  CITATIONS

1. IRS.gov, March 5, 2021 2. FINRA.org, 2021 3. IRS.gov, March 5, 2021 4. TheBalance.com, April 27, 2021 5. Finaid.org, 2021

Pat Reding and Bo Schnurr may be reached at 800-288-6669 or pbh@berthelrep.com.

Registered Representative of and securities and investment advisory services offered through Berthel Fisher & Company Financial Services, Inc. Member FINRA/SIPC. PRISM Wealth Advisors LLC is independent of Berthel Fisher & Company Financial Services Inc. This material was prepared by MarketingPro, Inc., and does not necessarily represent the views of the presenting party, nor their affiliates. This information has been derived from sources believed to be accurate. Please note - investing involves risk, and past performance is no guarantee of future results. The publisher is not engaged in rendering legal, accounting or other professional services. If assistance is needed, the reader is advised to engage the services of a competent professional. This information should not be construed as investment, tax or legal advice and may not be relied on for the purpose of avoiding any Federal tax penalty. This is neither a solicitation nor recommendation to purchase or sell any investment or insurance product or service, and should not be relied upon as such. All indices are unmanaged and are not illustrative of any particular investment.

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editorial

Best Practices for Vaccine Documentation

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

Without question, vaccine claims are on the rise! Consequently, PAAS National® analysts have recently seen an increased number of PBM audits for these claims. Consider a few best practices to reduce your risk of audit recoupments:

Billing

Quantity - Submit the correct NCPDP billing unit of each (EA) or milliliter (mL) based on vaccine product Day Supply - NCPDP recommends that all vaccine claims be submitted as a 1-day supply Origin Code

Submit the origin code in accordance with how you received the prescription • 1 – written, prescription obtained via paper.

• 2 – telephone, prescription obtained via oral instructions or interactive voice response using a phone.

• 3 – electronic, prescription obtained via SCRIPT or HL7 Standard transactions, or electronically within closed systems.

• 4 – facsimile, prescription obtained via transmission use a fax machine.

• 5 – pharmacy, this value is used to cover any situation where a new Rx number needs to be created from an existing valid prescription such as traditional transfers, intrachain transfers, file buys, software upgrades/migrations, and any reason necessary to “give it a new number. This value is also the appropriate value for “Pharmacy dispensing” when applicable such as BTC (behind the counter), Plan B, established protocols, pharmacists’ authority to prescribe, etc.

Note that codes 1-4 represent patient-specific prescriptions while code 5 covers various other situations

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Prescriber ID • Submit the NPI of the prescriber

• This would be the prescriber of a patient-specific prescription or standing protocol

• This would be the pharmacist Type 1 NPI (individual) as per state law where pharmacists have prescribing authority or when ordered under PREP Act declaration during COVID-19 pandemic

Documentation Item

Authority to Administer • Prescription • Standing Protocol • Collaborative Practice Agreement (CPA) • PREP Act Declaration

Screening Checklist

Vaccine Administration Record (VAR)

VIS or EUA Fact Sheet

Comments

Requested in audits

• You may have a patient-specific prescription with all elements required by state law • You may have a standing protocol or collaborative practice agreement

Yes

• For situations where you are administering pursuant to a protocol, CPA or PREP Act declaration, PAAS recommends creating a “placeholder prescription” with all normal prescription elements for your files Not requested by PBMs, however should retain for your records Must document every administration (required by law) Include at least the following: 1. Date of administration 2. Vaccine manufacturer 3. Vaccine lot number and expiration date 4. Site of injection 5. Name and title of the person who administered the vaccine 6. Vaccine information statement (VIS) or EUA Fact Sheet • Date printed on the VIS • Date the VIS was given to the patient or parent/ guardian Most current version must be provided prior to each administration (required by law)

No

Yes

No

PAAS Tips: • Common errors found during audits are wrong quantity billed and missing VAR documentation • See CDC website1 or immunize.org2 for sample forms and additional resources

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

2022 PAAS National® LLC All Rights Reserved

©

REFERENCES 1. https://www.cdc.gov/vaccines/hcp/admin/document-vaccines.html 2. http://immunize.org/

39 azpharmacy.org

Just as CPR helps even those without clinical training assist an individual having a heart attack, Mental Health First Aid prepares participants to interact with a person experiencing a mental health crisis. Mental Health First Aiders learn a 5-step Action Plan that guides them through the process of reaching out and offering appropriate support.

Check azpharmacy.org for upcoming offerings!

June 17th from 1-5pm (Part 1) June 19th from 8-12pm (Part 2) Need to attend both sessions

Brought to you by TRHC University and hosted by the Arizona Pharmacy Association Training Overview

• MedWise Advisor certification provides clinicians in various care settings with clinical and operational training for medication risk mitigation services.

Desired Outcomes

After completing this program, learners should demonstrate the ability to: • Make clinical recommendations based on the proprietary MedWise® Matrix • Identify medication-related problems and plan recommendations • Realize the increased significance of patient consulting • Review Systemized Nomenclature of Medicine (SNOMED) functionality

Offered in conjunction with the AzPA Annual Convention. Separate registration required. Do not need to attend convention to register.

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Individual Pharmacist Professional Liability

Employed Pharmacists Hospital Pharmacists Community Pharmacists Clinical Pharmacists Long-Term Care Pharmacists Nuclear Pharmacists Consultant Pharmacists Self-Employed Pharmacists Volunteer Pharmacists Retired Pharmacists Pharmacy Instructors Pharmacy Students

Apply at www.phmic.com/state-associat What if your current What if you have a employer does not second job, have the proper Apply at www.phmic.com/state-association volunteer, or give coverage inApply placeat towww.phmic.com/state-association advice to a friend protect you? or neighbor?

Are You Covered?

Are Covered?

Are You Covered?

What if your current

What if you have a second job, have with the proper volunteer, or give in a lawsuit? is available on a Claims-made or Occurrence basis limits of $1 million coverage in place to limits may be available). advice to a friend for each claim or occurrence and $3 million aggregate (higher protect you? or neighbor?

What if you were

Apply at www.phmic.com/state-association employer does not LIMITS OF LIABILITY AND WHAT WE COVER named individually

Are You Covered?

• Coverage Options: What if your current What current Exclude Sterile Compounding What aa Whatififyou youhave have What youwere were What if»ifyou employer does not » Include Sterile Compounding employer does not LIMITS OF LIABILITY AND WHAT WE COVER second job, second job, namedindividually individually named Coverage is available on a Claims-made or Occurrence basis with limits of $1 million have »lawsuit?

Advanced Pharmacist License have the proper proper volunteer, oror give volunteer, give inin a alawsuit? limits may be available). for each claim or occurrence and $3 million aggregate (higher coverage in place to What if your current • Immunizations and Other Drug Administration coverage in place to What if you have a advice to a friend What if you were advice to a friend • Coverage Options: employer does not second job, Compounding or neighbor? protect you? named individually • COVID-19 Testing and Immunizations protect you? » Exclude Sterile or neighbor? have the proper volunteer, or give in a lawsuit?• Drug Regimen » Include Sterile Compounding Reviews coverage in place to advice to a friend Pharmacist License • Medication Therapy Management » Advanced protect you? or neighbor?

• Immunizations and Other Drug Administration • Drug or Drug-Related Research • COVID-19 Testing and Immunizations OFLIABILITY LIABILITYAND AND WHAT WE COVER •WHAT Drug Regimen Reviews •LIMITS Medication Consultation LIMITS OF WE COVER • Medication Therapy Management Coverage isAND available onWE a Claims-made or Occurrence basis with limits of $1 million • Drug and Device Storage LIMITS OF LIABILITY WHAT COVER Coverage is available on a Claims-made orDrug-Related Occurrence basis with limits of $1 million • Drug or Research (higher limits may be available). for each claim or occurrence and $3 million aggregate Coverage is available on a Claims-made or Occurrence basis with limits of $1 million • Participation in Drug and Device • Selection Medication Consultation (higher limits may be available). for each claim or occurrence and $3 million aggregate for each claim or occurrence and $3 million aggregate (higher limits may be available).

• Drug and Device Storage • Coverage Options: • Point-of-Care Testing • Coverage Options: • Coverage Options: • Participation in Drug and Device Selection » Exclude Sterile Compounding Pharmacists License Defense $250,000 limit Testing » Exclude Sterile Compounding • Point-of-Care » Exclude Sterile Compounding » Include Sterile Compounding » Include Sterile Compounding Pharmacists License Board»ofInclude Pharmacy Imposed Costs* - $2,500 limitDefense - $250,000 limit Sterile Compounding » Advanced Pharmacist License » Advanced Pharmacist License Board of Pharmacy Imposed Costs* - $2,500 limit HIPAA - Other $50,000 limit • Immunizations Other Defense Drug Administration »Claim Advanced Pharmacist License • and Immunizations and Drug Administration HIPAA Claim Defense - $50,000 limit • COVID-19 Testing and Immunizations Assault $25,000 limit • Immunizations and Other Drug Administration Assault - $25,000 limit • COVID-19 Testing and Immunizations • Drug Regimen Reviews •Therapy COVID-19 Testing and Immunizations Sexual and Physical Abuse Liability $50,000 limit (higher limits may be available) (higher limits- may be available) Sexual and Physical Abuse Liability - $50,000 limit • Drug Regimen Reviews • Medication Management • Drug or Drug-Related Research • Drug Regimen Reviews • Medication Therapy Management *Costs do not include fines or penalties. *Costs do not include fines or penalties. Coverage may not be available in all states and territories.

• Medication •Consultation Medication Therapy Management • Drug or Drug-Related Research See policy full description of coverages.

Coverage may not be available in all states and for territories.

• Drug and Device Storage • Drug or Drug-Related Research • Medication Consultation • Participation in Drugfor andfull Device Selectionof coverages.

See policy description • Point-of-Care • Testing Drug and Device Storage • Medication Consultation Pharmacists License Defense - $250,000 limitand Device Selection • Participation in Drug • Drug and Device Storage Apply at www.phmic.com/state-associat Board of Pharmacy Imposed Costs* - Testing $2,500 limit • Point-of-Care • Participation in Drug and Device Selection HIPAA Claim Defense - $50,000 limit Pharmacists Mutual Insurance Company Pharmacists License Defense - $250,000 limit • Point-of-Care Testing 808 Highway 18 W | PO Box 370 |www.phmic.com/state-association Algona, Iowa 50511 Assault - $25,000 limit Apply at P. 800.247.5930 | F. 515.295.9306 | info@phmic.com Board of Pharmacy Imposed Costs* $2,500 limit limits-may be available) Sexual and Pharmacists Physical Abuse Liability - $50,000 limit (higher License Defense - $250,000 limit HIPAA Claim Defense - $50,000 limit Pharmacists Mutual Insurance Company *Costs do not Board include fines or penalties. of Pharmacy Imposed Costs* - $2,500 limit 41 808 Highway 18be Wavailable | PO Box 370 | Algona, Iowa 50511 Coverage may not in all states and territories.

Assault $25,000 limit P. 800.247.5930 | F. 515.295.9306 | info@phmic.com Claim Defense - $50,000 limit Looking for Personal Insurance?

See policy forHIPAA full description of coverages. azpharmacy.org Sexual-and Physical Abuse Liability - $50,000 limit (higher limits may be available) Assault $25,000 limit Sexual Physical Abuse Liability - $50,000 limit (higher limits may be available) *Costs and do not include fines or penalties.