North Carolina Pharmacist Volume 103 Number 1

North Carolina Pharmacist Volume 103 Number 1 Winter 2022

Advancing Pharmacy. Improving Health.

Register Now! 2022 NCAP Annual Convention Early Bird Rates End April 15th

Official Journal of the North Carolina Association of Pharmacists ncpharmacists.org

Call for Articles North Carolina Pharmacist (NCP) is currently accepting articles for publication consideration.

We accept a diverse scope of articles, including but not limited to: original research, quality improvement, medication safety, case reports/case series, reviews, clinical pearls, unique business models, technology, and opinions.

NCP is a peer-reviewed publication intended to inform, educate, and motivate pharmacists, from students to seasoned practitioners, and pharmacy technicians in all areas of pharmacy.

Articles written by students, residents, and new practitioners are welcome. Mentors and preceptors – please consider advising your mentees and students to submit their appropriate written work to NCP for publication.

Don’t miss this opportunity to share your knowledge and experience with the North Carolina pharmacy community by publishing an article in NCP. Click on Guidelines for Authors for information on formatting and article types accepted for review.

For questions, please contact Tina Thornhill, PharmD, FASCP, BCGP, Editor, at tina.h.thornhill@ gmail.com.

North Carolina Pharmacist is the Official Journal of the North Carolina Association of Pharmacists Located at: 1101 Slater Road, Suite 110 Durham, NC 27703 Phone: (984) 439-1646 Fax: (984) 439-1649 www.ncpharmacists.org

Official Journal of the North Carolina Association of Pharmacists 1101 Slater Road, Suite 110 Durham, NC 27703 Phone: (984) 439-1646 Fax: (984) 439-1649

www.ncpharmacists.org

North Carolina Pharmacist Volume 103 Number 1

Winter 2022

EDITOR-IN-CHIEF Tina Thornhill

A Few Things Inside

LAYOUT/DESIGN Rhonda Horner-Davis

• From the Executive Director...................................................................................4

EDITORIAL BOARD MEMBERS

• From the President.............................................................................................5

Anna Armstrong Jamie Brown Lisa Dinkins Jean Douglas Brock Harris Amy Holmes John Kessler Angela Livingood Bill Taylor

BOARD OF DIRECTORS EXECUTIVE DIRECTOR Penny Shelton PRESIDENT Matthew Kelm PRESIDENT-ELECT Ouita Gatton PAST PRESIDENT Elizabeth Mills TREASURER Ryan Mills SECRETARY Paige Brown Kevin Rhash, Chair, SPF Tyler Vest, Chair, NPF Trish Mashburn, Chair, Community Mary-Haston Vest, Chair, Health-System Amber M Lussier, Chair, Chronic Care Holly Canupp, Chair, Ambulatory Macary Weck Marciniak, At-Large Vinay Patel, At-Large Riley Bowers, At-Large North Carolina Pharmacist (ISSN 0528-1725) is the official journal of the North Carolina Association of Pharmacists.

An electronic version is published quarterly. The journal is provided to NCAP members through allocation of annual dues. Opinions expressed in North Carolina Pharmacist are not necessarily official positions or policies of the Association. Publication of an advertisement does not represent an endorsement. Nothing in this publication may be reproduced in any manner, either whole or in part, without specific written permission of the publisher.

• Call for Posters.......................................................................................................6 • Time to Nominate...................................................................................................7 • COVID-19 Vaccine Equity...................................................................................10 • 13 Steps for Ethical and Safe Practice ......................................................................14 • Impact of Pharmacy Benefit Managers..................................................................16 • New Drug Monograph..........................................................................................23 • All Hands on Deck................................................................................................34 • Let’s Stay Connected............................................................................................38 • NCAP Spotlight...................................................................................................40 • New Resources ................................................................................................43

North Carolina Pharmacist is supported in part by: • Alliance for Patient Medication Safety (APMS).....................................9

• Edupharmtech .........................................................................................9 • EPIC Pharmacies Inc ..............................................................................9 • Pharmacy Quality Commitment ...........................................................12 • Working Advantage ..............................................................................14 • Pharmacy Technician Certification Board (PTCB) ..............................15 • NCAP Career Center ............................................................................22

• Pharmacists Mutual Companies ......................................................37-44 • VUCA Health .......................................................................................39 • The Partnership for SAFEMEDICINES...............................................42 • Your Community Health Plan ..............................................................46 CORRECTIONS AND ADVERTISING For rates and deadline information, please contact Rhonda Horner-Davis at rhonda@ncpharmacists.org

Connect With Us!

•From the Executive Director• Penny Shelton, PharmD, BCGP, FASCP

Inside NCAP Operations: Mentoring & Leading

Approximately a decade ago, I had the amazing opportunity to participate in a year-long leadership development program. The program brought together thirty individuals from across the U.S. who were interested in taking their leadership skills to the next level.

Four times during the year, we met in person as a group; and throughout the year, we had a series of leadership books and assignments that we were required to complete and discuss with a mentor. The experience was extremely rewarding for my personal and professional development.

Recently, I was reflecting on my time spent during this program. Although there were many fond memories, a couple left significant lasting impressions, one of which points to leading as less about strategies and tactics we frequently associate with leadership skills and more about leading by mentoring.

This approach recognizes that we have many duties and responsibilities.

Still, if we are good leaders, we should embrace one specific obligation: to focus less on self-development and more on mentoring and lifting up those around us. One of the leadership program’s instructors used a visual to emphasize how leaders need to be perceived instead of how those around us may think of us. She kept a set of Matryoshka dolls on her desk. Whenever she met with a new employee, she would slowly and intentionally begin unnesting the dolls during the conversation, with each doll unveiled becoming smaller and smaller. Eventually, she would ask

the employee, “which of these dolls represents you, and which represents me?” Inevitably, and with some hesitancy, most employees would point to the smallest doll to represent themselves and the largest doll to represent her as their boss. Then the leadership and, quite frankly, the culture-setting teachable moment would happen; whereby, she would point out the smallest doll, and say, this is the inner doll, the one that acts behind the scenes, as the core, supporting all of the other dolls. The largest, most visible doll is you because I want to support your growth and development to become as big and as great as you desire.

There is another Matryoshka analogy that is sometimes used in leadership circles, and that is, if a leader hires only individuals who are less capable than themselves, then you cater to the status quo and squash all growth potential for the organization. These Russian Nesting Dolls analogies are relevant here at home, at NCAP.

A few years ago, the NCAP Board of Directors approved a new staff pharmacist position, and after careful consideration, I felt our Association and its members would best be served by the addition of a Director of Practice Advancement. NCAP hired Dr. Cheryl Viracola to fill this position, and most of you know that she has helped transform our programming and resources. However, until now, few had insight into my approach to hiring her. Although Cheryl and I had a similar number of years in practice, the similarities stop there. Because, when hiring, I try to apply the second Matryoshka philosophy. Cheryl has different strengths and experiences; she even has a completely different Page 4

network of contacts. She thinks about issues and tackles problems differently than I do. The fact that we are different has served the Association well. It has made us stronger as an Association because it has expanded and diversified the skillset and talents among the NCAP staff, which helps us grow and avoid the status quo.

Nine months ago, NCAP started an Executive Fellowship, and we brought on Dr. Megan Witkowski as our first Fellow. Megan has been an amazing addition to the staff. Residencies and Fellowships are post-graduate opportunities for broadening knowledge and experience. I view our NCAP Executive Fellowship as an intensive and immersive, personal, and professional development opportunity.

Here at NCAP, we believe there is no better way to learn than by doing; and Megan is fully embedded in our operations, doing and leading various projects, contracts, and initiatives. We work diligently to create meaningful roles for our Fellow and avoid mere observation or shadowing. The trust we impart to our Fellow and the experiences and opportunities we provide are purposeful and valuable. NCAP is investing in a future leader for our profession, and I am extraordinarily pleased to announce that Megan has elected to complete an optional second year. Perhaps a sign that we are doing it right! NCAP will certainly benefit from her decision to extend her Fellowship. Still, I am mostly happy that we can build off of the first year, helping further her development into that biggest and brightest of the Matryoshkas.

Pharmacy Proud, Penny

•From the President• Matt Kelm, PharmD

Thank You for the Opportunity to Serve

Colleagues,

Thank you for the opportunity to serve the pharmacy professionals of North Carolina as the President of the North Carolina Association of Pharmacists.

While I have had the good fortune of forming professional and personal relationships with many of you, I wanted to take a moment in my inaugural letter to introduce myself more broadly.

After graduation from Purdue University College of Pharmacy in 2006, I relocated to North Carolina and began my career as a clinical pharmacist at Duke University Hospital. I continued my formal education in 2012 by earning a Masters in Healthcare Administration from UNC Chapel Hill. Shortly after moving to North Carolina, I married my wife Katie. We originally met in undergrad at Purdue University, and I joined her in North Carolina while she completed her PhD in Neuropharmacology at UNC Chapel Hill.

She remains active in the pharmaceutical industry as an Associate Director for Global Medical Writing at PPD, part of Thermo Fisher Scientific. We have three wonderful children; Jude (11), Cecilia (7) and Felicity (2) and reside in Chapel Hill.

I have served in a variety of roles throughout my nearly 16 years at Duke and currently serve as our Associate Chief Pharmacy Officer for Oncology Pharmacy Services with health system responsibilities. My professional interests include development and implementation of progressive pharmacy services within large, academic medical centers through collaboration with

the interdisciplinary team to achieve optimal patient outcomes, further best practices, and meaningfully contribute to the financial health of the organization.

Students and residents who have an experiential rotation with me are exposed to my philosophy that involvement in our professional organizations is not only a responsibility that we have to the profession, but also an investment that will grow exponentially. The relationships, knowledge, and opportunities that result from active involvement in professional organizations provides a career-long impact. I have seen firsthand the impact and importance of knowing your colleagues in the state and the ability for meaningful state legislation to impact pharmacy practice and patient care in North Carolina through advocacy and collaboration. In the past year, NCAP had remarkable success in supporting five legislative priorities, three of which were signed into law. These included COVID relief, reform of pharmacy benefit manager practices, and broader authority for medication administration and public health. Quite simply, NCAP, delivered! I encourage the pharmacy professionals in our state to build upon this momentum through membership, involvement, and financial support of the NCAP Advocacy Fund and Pill PAC. In the past several months, I have been fascinated by the Beatles Documentary Get Back. While the intent of Paul McCartney’s lyrics from this iconic song had a different purpose, the words resonate with me for NCAP in the coming year. As an organization, we will be getting back to where we once belonged.

Our intent is to join many other professional organizations in providing Page 5

a safe and responsible in-person convention opportunity on June 9th and 10th at the Benton Convention Center in Winston-Salem, North Carolina. I encourage all pharmacy professionals in our state to take advantage of this opportunity to Get Back with one another. Use this opportunity to connect with colleagues you have only seen via Zoom in the past two years, form a new relationship, and gain new knowledge or skills from our continuing education programs. My second request would be to double the impact of your investment in our profession by inviting a colleague not currently active in NCAP to join you in the organization and attend the convention.

It is with our collective voice and engagement that we will continue in our mission of “Advancing Pharmacy, Improving Health.” I look forward to engaging with many of you throughout the course of this year.

Best, Matt

www.medicationsafety.org

NCAP Annual Meeting to Hold its 7th Annual Poster Session!

The NCAP 2022 Annual Convention will be June 9th and 10th at the Benton Convention Center in Winston-Salem, NC. We will host our 7th annual poster session during the convention. Presenting a poster at this NCAP event is an excellent opportunity to share your research with pharmacy practitioners all around the state! Selected abstracts will be published in the North Carolina Pharmacist: The Official Journal of the North Carolina Association of Pharmacists. Submissions by practitioners, students, and residents are welcome!

Details of when and how the poster session will be presented will be advised to all authors of the posters chosen for presentation when they are notified their work has been selected.

Abstract Headings: Objective, methods, results, conclusions • Case Report or Series: Description of a unique patient case or series. May include novel indication, dose or administration of a medication. Abstract Headings: Introduction, case(s), discussion • Word Count: 300 words (excluding author names and title) Abstracts describing ongoing research will be considered with partially completed data. Descriptions of planned research without any data will not be accepted. Abstracts will be evaluated based on readability and organization, relevance, and potential impact to pharmacy practice.

Please submit your name, your credentials, and your abstract as a Word document to Mindy Parman mgparman@gmail.com. Deadline: April 8, 2022.

Status of submissions will be communicated to authors

by April 29, 2022.

Categories: • Original Research: Clinical or educational research appealing to an audience of pharmacy professionals in North Carolina. May include health services, pharmacotherapy, medication safety, or patient outcomes.

Abstract Headings: Objective, methods, results, conclusions • Quality Improvement Evaluations: Assessments of quality improvement measures such as medication use evaluations or process improvements. May include ideas and practices new to system, or practice setting.

Abstracts will be printed as submitted in the North Carolina Pharmacist: The Official Journal of the North Carolina Association of Pharmacists. Edits to abstracts cannot be made after submission.

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NOTE: Poster presenters MUST register for the Convention for the day of presentations. There will be no discounted registration, honorarium or speaker fee.

Time to Nominate!

Example of a structured abstract: Category: Original Research

Title: Evaluation of Compliance with National Guidelines for Insulin Initiation Authors: Kira Harris, PharmD, BCPS, CDE1,2, Jacqueline Olin, MS, PharmD, BCPS, CPP, CDE, FASHP, FCCP2 Institution: Crown Point Family Physicians, Charlotte NC; Wingate University School of Pharmacy, Wingate NC Objective: The primary purpose of this study was to determine compliance with the American Diabetes Association recommendation to initiate insulin in patients with an A1c≥10% at an outpatient family medicine clinic in 2014. Secondary objectives were to determine if initiation of insulin within 3 weeks of an A1c ≥ 10% increased the rate or decreased the time to achieve an A1c<7%, and to determine if pharmacist involvement increased the rate of reaching an A1c<7%.

Methods: The medical records of 121 patients with type 2 diabetes mellitus (T2DM) and an A1c≥10% from January 1, 2014 to December 31, 2014 were reviewed.

Patients already receiving insulin or those without a follow-up A1c were excluded. Data collected included patient demographics, duration of diabetes, baseline and follow-up diabetes medications, baseline and follow-up A1c values, as well as pharmacy referrals.

Results: Fifty-five patients with a mean age of 55 years, a mean duration of diabetes of 6.4 years, and a mean baseline A1c of 11.7% were included. Most patients were receiving no therapy (29%), monotherapy (27%) or dual therapy (29%) at baseline. Insulin was initiated in 5 patients (9.1%, p<0.05) within 3 weeks of the qualifying A1c. Another 5 patients (p<0.05) received insulin at some point during the study. An A1c<7% was achieved in 35.6% of patients not receiving insulin, 20% of patients receiving immediate insulin, and no patients who received insulin after 3 weeks. The mean time to A1c<7% was 6 months for patients not on insulin and 3 months for those receiving immediate insulin. Thirty-three percent of patients who met with a pharmacist reached an A1c<7% compared to 30% of patients who did not.

Conclusion: Adherence with insulin initiation guidelines and rate of achieving A1c<7% in patients with A1c≥10% is low and increasing pharmacy involvement may increase the rate of reaching goal A1c.

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AWARDS

2022 It’s that time again. Time to nominate someone you know for one of the many awesome awards we present during our annual convention. Each and every one of you knows someone who has been knocking it out of the park. When it comes to doing their job, no one does it better. They inspire, encourage and go above and beyond expectations. This year our award recipients will be recognized during the NCAP 2022 Convention, June 9 and 10 at the Benton Convention Center in Winston-Salem, NC. Click here to find the perfect award to nominate that pharmacy hero you have in mind. Submit your nominations by April 4, 2022. Any questions? Contact Angie at angie@ncpharmacists.org.

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COVID-19 Vaccine Equity By: Luis Trejo, PharmD Candidate, Paul Tomkiewicz, PharmD Candidate, Dr. Irene Ulrich, and Dr. Kimberly L. Nealy

Campaigns of mass vaccination and vaccine discovery have resulted in humanity’s greatest triumphs against diseases. The discovery of the polio vaccine by Jonas Salk and later Albert Sabin in the 1950s resulted in eradicating a disease that paralyzed between 13 and 20 thousand patients per year. Mass vaccination against smallpox between 1969 and 1977 resulted in the total eradication of Variola major.

Nine months after being declared a pandemic, the first vaccine against COVID-19 was given in December 2020. Since then, nearly 500 million doses of the vaccine have been administered in the United States.

(1) Despite this success, health care inequity in the United States, particularly in emergency preparedness, is well-established and remains a significant barrier to achieving the goal of 90% of the eligible population being vaccinated. (2) African American and Latinx populations are less likely to be vaccinated than any other racial and ethnic groups.

In addition to this, they are more likely to become seriously ill and die from COVID-19. (3) While equality suggests that everyone has the same access to a resource, equity ensures that everyone has fair access to that resource.

Many factors create barriers to access and acceptance of vaccine efforts, many stemming from social determinants of health. These factors include racism and other forms of discrimination, gaps in health care access, education, income, wealth gaps, transportation, and lack of trust in the medical system.

(3) The Centers for Disease Control and Prevention (CDC) works with national, state, local, and community partners and provides funding to help overcome these factors and increase equity. They have provided $3 billion to support local health departments and community-based organizations in launching new programs and incentives to increase vaccine access, acceptance, and uptake. An additional $2.25 billion has been awarded specifically to support efforts that address COVID-19 health disparities. (3) North Carolina (NC) has implemented various outreach and data strategies to promote vaccine equity. The state has increased the supply of COVID-19 vaccines to serve counties with large, historically marginalized populations. It has allocated funding to remove systemic barriers to access, such as awarding $2.5 million to local transit authorities to offset transportation costs to vaccine sites.

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(4) Additionally, The NC Department of Health and Human Services (NCDHHS) has partnered with the NC Counts Coalition to implement the Healthier Together initiative to increase COVID-19 vaccinations among historically marginalized racial and ethnic populations.

Healthier Together has awarded $500,000 to 27 community-based organizations to support equitable vaccine distribution in NC. These organizations utilize the funds to conduct vaccine outreach and education, help with vaccine scheduling, arrange transportation, and coordinate local vaccine events. (5)

These efforts by NC to help shrink the vaccination gap have resulted in some success. As of October 6, 2021, the share of vaccinations received in NC was 18.3% by Black or African Americans, 8.6% by Hispanic/Latinx individuals, and 0.9% by American Indians. In the 4 weeks prior to October 6, 2021, the share of vaccinations were: • 23.1% by Black or African Americans • 12.0% by Hispanic/Latinx individuals • 1.2% by American Indians (5) These vaccination rates are more

consistent with the demographics of NC in which the population identifies as 22.2% Black or African American, 9.8% Hispanic/Latinx, and 1.6% American Indian. (6) This data suggests that though there is still a vaccination gap in historically marginalized populations, the data is trending in the right direction.

The national data also suggests that the disparities in vaccination rates are decreasing. Until March 25, 2021, African Americans and Latino represented 7.2% and 7.4% of the total COVID-19 vaccination. (4) As of August 27, 2021, the percentages had significantly increased, with African Americans and Latinos representing 9.3% and 16.1% amongst those fully vaccinated. (1)

While vaccination numbers reflect improvement, it is important to understand the root causes of vaccine hesitancy to increase reach to the most vulnerable populations. Notably, medical and vaccine mistrust is pervasive in Black and African American communities, including public figures and medical professionals. (7) Methods to overcome vaccine hesitancy require a consistent message from health care providers and a multilevel approach, including pharmacists in all settings.

(8)

As the most accessible and frequently visited healthcare professional, pharmacists are well-positioned to improve vaccination rates and increase vaccine access and equity.

(9) In addition to being the most accessible, pharmacists are among the most highly trusted professionals.

(10) Motivational interviewing has been shown to be an effective tool in overcoming vaccine hesitancy across many disciplines (including pharmacy) and various vaccines. (8,11,12) Pharmacists are in constant contact with the community as they work in many settings, including community pharmacies, hospitals, physi-

cian offices, clinics, and long-term care facilities. Pharmacists serve as patient educators, advocates, and immunizers, and by using non-judgmental motivational interviewing skills, they can help overcome vaccine inequity. By simply engaging in open-ended conversations about safety and efficacy, myths and misconceptions, and addressing patients’ concerns and fears, pharmacists can motivate patients to obtain vaccines. (13) For more information on COVID-19 vaccine equity and access, visit: https://www.who.int/campaigns/ vaccine-equity https://covid19.ncdhhs.gov/vaccines/nc-vaccine-strategy To find a COVID-19 vaccine near you, visit: Vaccines.gov

Authors: Luis GerardoTrejo, PharmD Candidate, Class of 2022, UNC Eshelman School of Pharmacy, ltrejo@email.unc.edu; Paul Tomkiewicz, PharmD Candidate, University of North Carolina at Chapel Hill; Irene Ulrich, PharmD, BCACP, CPP, Clinical Pharmacist, MAHEC Department of Family Medicine, Associate Professor of Clinical Education, UNC Eshelman School of Pharmacy, Clinical Assistant Professor, UNC School of Medicine, PGY2 Ambulatory Care Residency Program Director, MAHEC/UNC Eshelman School of Pharmacy; Kimberly L. Nealy, PharmD, BCPS, CDCES, CPP, Scientific Director, Medical Specialties, Clinical Education Alliance References:

1. CDC COVID Data Tracker. Centers for Disease Control and Prevention. Published March 28, 2020. Accessed December 10, 2021. https://covid.cdc.gov/covid-data-tracker 2. Golden SH, Galiatsatos P, Wilson C, et al. Approaching the COVID-19 Pandemic Response With a Health Equity Lens: A Framework for Academic Health Systems. Acad Med. 2021;96(11):1546-1552.

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doi:10.1097/ACM.0000000000003999 3. CDC. Vaccine equity for racial and ethnic minority groups. Centers for Disease Control and Prevention. Published November 2, 2021. Accessed December 10, 2021. https://www.cdc.gov/coronavirus/2019-ncov/community/health-equity/vaccine-equity.html 4. Thoumi A. Prioritizing Equity in COVID-19 Vaccinations: Promising Practices from States to Reduce Racial and Ethnic Disparities. Margolis Center for Health Policy. Published March 31, 2021. Accessed December 10, 2021. https://healthpolicy. duke.edu/publications/prioritizing-equity-covid-19-vaccinations-promising-practices-states-reduce-racial-and 5. Promoting COVID-19 Vaccine Equity in North Carolina. North Carolina Department of Health and Human Services; 2021:10.

Accessed December 10, 2021. https:// covid19.ncdhhs.gov/media/2388/open 6. U.S. Census Bureau QuickFacts: North Carolina. Accessed December 10, 2021. https://www.census.gov/quickfacts/NC 7. Hostetter M, Klein S. Understanding and Ameliorating Medical Mistrust Among Black Americans. The Commonwealth Fund. doi:10.26099/9grt-2b21 8. Tsui J, Vincent A, Anuforo B, Btoush R, Crabtree BF. Understanding primary care physician perspectives on recommending HPV vaccination and addressing vaccine hesitancy. Hum Vaccines Immunother.

2021;17(7):1961-1967. doi:10.1080/2164 5515.2020.1854603 9. Manolakis PG, Skelton JB. Pharmacists’ Contributions to Primary Care in the United States Collaborating to Address Unmet Patient Care Needs: The Emerging Role for Pharmacists to Address the Shortage of Primary Care Providers. Am J Pharm Educ.

2010;74(10):S7.

10. Brenan M. Nurses Again Outpace Other Professions for Honesty, Ethics. Gallup.com.

Published December 20, 2018. Accessed December 10, 2021. https://news.gallup. com/poll/245597/nurses-again-outpace-professions-honesty-ethics.aspx 11. Meyer BA, Viskupič F, Wiltse DL. Pharmacists to partner with religious leaders to overcome vaccine hesitancy among Christians. J Am Pharm Assoc JAPhA. Published online August 26, 2021:S15443191(21)00366-6. doi:10.1016/j. japh.2021.08.025 12. Breckenridge LA, Burns D, Nye C. The use of motivational interviewing to overcome COVID-19 vaccine hesitancy in primary care settings. Public Health Nurs Boston Mass. Published online October 29, 2021. doi:10.1111/phn.13003 13. Terrie Y. The Role of the Pharmacist in Overcoming Vaccine Hesitancy. US Pharm.

2021;45(4):28-31.

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2021 Recipients of the “Bowl of Hygeia” Award

Rebecca Sorrell Alabama

Richard A. Holt Alaska

Michael R. Blaire Arizona

Paul Ackerman Florida

Laird Miller Georgia

Chris Lynch Illinois

Robert E. Hodge II Arkansas

Omolola A. Adeoye-Olatunde Indiana

Katherine E. Bass California

Nancy Stolpman Colorado

Jill Fitzgerald Connecticut

Megan Willey Delaware

Steven W. Sayler Iowa

Doug Funk Kansas

Melinda C. Joyce Kentucky

TJ Woodard Louisiana

Bill Mosby Mississippi

Salim (Sam) Tadrus Missouri

Mike Bertagnolli Montana

Jennifer Ortega New Mexico

Gary A. Rotella New York

Mollie Ashe Scott North Carolina

Cheri Kraemer South Dakota

Thomas Marcrom Tennessee

Amelia Arnold Charmaine Rochester-Eyeguokan JoAnn Sanborn Maine Maryland Michigan

Jennifer Tilleman Nebraska

Cheryl Durand New Hampshire

Lucio R. Volino New Jersey

Terry Altringer North Dakota

Greg Adams Oklahoma

Amy D. Valdez Oregon

Gregory Myers Utah

Troy D. Spaulding Vermont

The “Bowl of Hygeia”

Trish Klatt Pennsylvania

Charles Tarasidis Virginia

Tara Higgins Rhode Island

C. A. Leon Alzola Washington Photo Not Available

David E. Burke Ohio

Merrie Kay Alzola Washington Photo Not Available

John T. Johnson South Carolina

Carolyn Rachel-Price Washington DC

Charlotte Weller Texas

Krista D. Capehart West Virginia

Photo Not Available

Fran D’Egidio West Virginia

2020 Recipient Presented in 2021

Hashim Zaibak Wisconsin

Craig Frederick Wyoming

The Bowl of Hygeia award program was originally developed by the A. H. Robins Company to recognize pharmacists across the nation for outstanding service to their communities. Selected through their respective professional pharmacy associations, each of these dedicated individuals has made uniquely personal contributions to a strong, healthy community. We offer our congratulations and thanks for their high example. The American Pharmacists Association Foundation, the National Alliance of State Pharmacy Associations and the state pharmacy associations have assumed responsibility for continuing this prestigious recognition program. All former recipients are encouraged to maintain their linkage to the Bowl of Hygeia by emailing current contact information to awards@naspa.us. The Bowl of Hygeia is on display in the APhA History Hall located in Washington, DC. Page 13

13 Steps for Ethical and Safe Practice - An Internal Self-Check System By: Diana Jurss

The Institute for Safe Medical Practices (ISMP) is a well-known and highly effective organization that has done a world of good.

It excels at what it does by addressing the systems by which health care is delivered. Many, many improvements in processes such as labeling, procedures, communications, manufacturing, packaging, calculations, and education can be attributed to what ISMP has brought to light. However, as any pharmacist or pharmacy technician working for any length of time in either retail or institutional practices knows, not all co-workers are the same. That is, some pharmacists and technicians make way more errors than others, consistently way more errors than others. Why is this so, and what can be done to improve this situation?

While not every pharmacist or technician can be as good as the best co-worker we have ever had, each of us can take action to improve ourselves in order to become our personal-best practitioner!

Let us think about this topic, write about it, discuss it, share it with our students and even include a lecture or two in pharmacy curricula. Here is a starting point.

Thirteen steps for ethical and safe practice - an internal self-check system 1) Admit that although we are well-trained professionals, we are still human beings.

2) Believe in what we do, and the teamwork required to do it well.

3) Commit to becoming proficient with our resources and references.

4) Be totally honest and ethical with our department inventories, including medications and monies.

5) Do not be vague, ambiguous, or deceitful in any manner of business including billing and taxes.

6) Accept that we have strengths and weaknesses, as do our coworkers.

7) Remove all imperfect or questionable products from our shelves as well as unsafe distractions from our workplace.

8) Keep proper, accurate and updated records, documents, and licenses at all times.

9) Correct all errors as soon as we are aware, concealing nothing.

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10) Regard each workday, client and patient with fairness and our full attention.

11) Check, double check, and triple check all our work.

12) Constantly improve our knowledge, staying current with new products, laws, and developments.

13) Strive to be grateful and respectful for the privilege of serving and mentoring in healthcare.

Author: Diana Jurss RPh; Cullowhee, NC; dlpickle31@hotmail. com

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In order to receive savings, you must be a member of NCAP and you can register online at Working Advantage. com. You will be prompted to create an account with your email address. To receive your promo code check "My Promo Codes" located on the member home which can be found under the home tab on the menu bar.

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Impact of Pharmacy Benefit Managers on Pharmacies and Patients in North Carolina: Survey Results By: Rebecca Lee Dr. Beth Mills Dr. Katie Trotta M. Ryan Brownlow

Introduction Pharmacy Benefit Managers (PBMs) were originally created in the 1970s to serve as intermediaries between health plans and patients for adjudicating prescription claims and reducing administrative costs. Today, the role of the PBM in drug pricing is much more pervasive and includes negotiating prices and rebates with drug manufacturers, developing formularies, approving prior authorizations, and selecting pharmacies for their members to utilize. From the perspective of pharmacies, PBMs determine reimbursement rates for each drug and impart fees on the pharmacy if they are not meeting pre-specified quality standards. There is anecdotal evidence of the negative impact PBMs can have on independent pharmacies, patients, and the healthcare system as a whole regarding medication cost and access.

Many pharmacy owners state that independent pharmacy reimbursement began to diminish several years ago with a continued steady decline up until today.

(1) This is not a newfound concern in healthcare, with evidence of pricing difficulties dating back to the early 2000s. PBM Abuses is a website dedicated to sharing patient stories about the dangerous consequences of such middle-men in regulating prescription access for oncology patients. (2) PBM Abuses explains the challenges patients face when trying to obtain high-cost,

and often life-saving, medications associated with their oncological care due to these insurance middlemen.

In May 2018, the U.S. Department of Health & Human Services (DHHS) released a blueprint outlining goals to lower the price of prescription medications; exploitation by the PBM industry is cited throughout the document. (3) In July 2021, President Biden signed Executive Order 14036, “Promoting Competition in the American Economy,” which addresses the high prices of prescription drugs. Shortly after, DHHS released “Comprehensive Plan for Addressing High Drug Prices” to respond to the Executive Order. Among the strategies outlined to make drug prices more affordable, transparency from and regulation over PBMs are noted. Even through numerous anecdotal evidence and lawsuits, PBMs continue to take advantage of the healthcare system. Kentucky, West Virginia, and Ohio are examples of states that have suffered monetary losses due to spread pricing when states switched to a privatized Medicaid model. In 2018, Ohio terminated contracts between the state’s Department of Medicaid and privatized PBMs. (4) “A state-commissioned report showed PBMs billed taxpayers $223.7 million more for prescription drugs in one year than they reimbursed pharmacies to fill those prescriptions.”

(4)

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On December 10, 2020 the Supreme Court of the United States ruled unanimously in favor of Arkansas Act 900 in their decision on Rutledge v. Pharmaceutical Care Management Association (PCMA). (5) The law in question prohibits PBMs from reimbursing pharmacies below drug acquisition cost for specialty medications.

Previously enacted by the state in September 2015, PCMA, an association representing PBMs, immediately opened a lawsuit against the state, saying the state was acting outside of its scope in regulating the insurance companies in this way. The Supreme Court’s unanimous decision in favor of the Arkansas law paved the way for individual states to regulate PBMs at the state level.

While there is ample anecdotal evidence of the negative impact of PBM practices on independent pharmacies, compiled data on this topic is lacking, especially within North Carolina pharmacies. The purpose of our study was twofold: first, to gather survey data from the perspective of pharmacy managers and/or owners on the impact of PBM practices on independent pharmacies and patients in North Carolina, and second, to collect specific evidence of unfair and abusive PBM practices.

Methods This project was an observational, cross-sectional study from November 2020 to April 2021. Two separate collection tools were created. First, a survey was developed to gather information from pharmacists in North Carolina on their opinion of PBM’s impact on their business and patient care in the cloud-based software program, Qualtrics. Second, an online form was created to collect de-identified evidence from pharmacists of specific examples of PBM abuse encountered in their pharmacy.

Investigators distributed the survey and online form to community pharmacists across North Carolina via the North Carolina Association of Pharmacists (NCAP).

The survey and form were also provided to members of NC Independent Pharmacy, a private Facebook group of pharmacy owners and pharmacists in independent pharmacies across the state. All evidence collected was used to supplement advocacy efforts by NCAP.

Included participants were pharmacy owners or managers at independent pharmacies in North Carolina.

The exclusion criteria included any pharmacy owner or manager who did not consent to the use of their information for the study. The primary outcome of our study was to describe the impact PBM practices have on independent pharmacies and their patients in North Carolina. While 55 participants gave permission to use their information in this research project anonymously,

22 participants did not meet the inclusion criteria and could not continue the survey.

Results Through the distribution of the Qualtrics survey via NCAP and social media, responses were gathered from a total of 33 participants: 19 pharmacy owners, nine pharmacy managers, and five pharmacy owners/managers. Those who were neither pharmacy owners nor pharmacy managers were prevented from completing the survey. Of the included respondents, 90.3% owned one or two pharmacies; 22.2% owned pharmacies in the Mountains region, 47.2% owned pharmacies in the Piedmont region, and 30.6% owned pharmacies in the Coastal Plains region. On average, 15% of the respondents reported the nearest large-chain pharmacy (e.g., Walgreens, CVS) was located further than five miles from their pharmacy. When asked if their pharmacy was the only one in the area but not “in-network” with an insurance company, 34.6% of the participants responded “yes.”

Survey respondents reported specific examples of unfair practices by PBMs, including arbitrary direct and indirect remuneration (DIR) fees, decreased reimbursement, forced mail order, preferred networks, and patient steering. In addition, 87% of respondents reported being forced to turn away a patient or their prescription due to the high net loss to the pharmacy if the prescription was filled (Figure 1). Sixty-seven percent of pharmacies had to turn away patients more than five times a month, and 41% had to turn away patients more than ten times a month (Figure 2). Over half of respondents reported that their pharmacy was the only area pharmacy but was not “in-network” (Figure 3). Of the pharmacists who were planning to retire soon, 70% reported that the planned retirement resulted from financial hardships from PBM abuses affecting their pharmacy (Figure 4). Not surprisingly, 100% of participants stated that they would support a bill to reform PBM practices in North Carolina.

In addition to survey responses, pharmacists submitted 67 specific examples of PBM abuse encountered in day-to-day experiences in their pharmacies. A few of the comments received in the survey regarding preferred plans, forced mail order, and DIR fees included: “Currently, our patients are receiving letters from [an insurance company] stating that their plan will no longer prefer us. The letters are vague and imply that our patients will incur much greater prescription drug costs by using ourpharmacy in 2021. In reality, the price dif-

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ferences seem minimal as we will still be in the network (just not preferred) for the next year.”

“Negative reimbursement leads to turning people away who may never come back. Forced mail order for many [with different plans, including those with] the PBM for our state health plan. Huge employers in areas requiring employees to go to chain or mail order…DIR fees across the board especially with [an insurance company] reimbursement way below acquisition cost.”

“Patient receives simvastatin, and the copay comes back $144.85. This medication does not cost this amount on cash price. PBM then takes a $125 DIR fee. The patient comes to the pharmacy to pick up maintenance medication (metformin, sertraline, simvastatin, etc.). When a prescription is processed, rejection comes up stating the patient must use mail order pharmacy and there will be no copay to use mail order pharmacy. The patient wants to transfer prescriptions to [a chain pharmacy].

When processing prescriptions for QVAR, patients are required to pay over $200, was paying $47 at [a chain pharmacy].”

“Nearly every single insulin Rx I fill for a patient results in a loss for my pharmacy due to DIR fees or low reimbursement. These are life-saving medications that I feel strongly I cannot deny the patient. Yet to continue to supply them fill after fill will, without question, be a contributor in the downfall of my business resulting in my not being able to serve all of my other patients. The current practices are unethical and dangerous. Additionally, I cannot properly staff my pharmacy, especially with the onset of COVID vaccines, which results in higher stress levels and the pharmacist being unable to pay the proper amount of attention to the patients’ medications.

Again, unethical practice and downright dangerous.”

“Multiple audits from [one insurance company], when they are only allowed one per year. Hired an audit company to respond to [them]. After we sent our information to [them] and it was correct, they still wanted to take ~$19,000 back. I called them and the lady from [the insurance company] laughed at me for trying to dispute the claims they said were wrong. No respect for the Pharmacy profession. We have paid ~$250,000 a year in DIR fees. We have a Clinical Pharmacy Tech and Pharmacist who are doing MTMs and calling patients, but you cannot force people to get their medication and take it correctly. The pharmacist is punished for the patient’s actions.”

Similarly, National Community Pharmacists Association (NCPA) collected information on PBM Abuses from pharmacy owners across the country. (6) Some highlighted comments they received include:

“A pharmacy in Virginia reported that their health plan changed their policy for maintenance medications for small group plans in the 3rd quarter of 2019. Patients are now required to obtain their medications through mail order or at CVS retail. This change occurred after Anthem switched from ESI to IngenioRx, which is operated by CVS. Due to this change, the pharmacy saw the patient’s out-of-pocket costs for insulin grow from $0 to over $500 for patients continuing to use their pharmacy.”

“Aetna/Caremark forced a patient in Connecticut to fill a 90-day supply of Symbicort at CVS pharmacy or CVS Caremark Mail Service Pharmacy. The patient would have to pay the full cost if he/she filled the prescription at the independent pharmacy of his/her choice.”

“One former pharmacy owner in Idaho reported that he served many patients in adult mental health homes who were on Invega Trinza. His reimbursement for that medication was reduced severely to where he was reimbursed $7,000 for a $7,500 medication. This bankrupted him and forced him out of pharmacy altogether.”

Discussion Evidence from pharmacy owners and managers suggests that PBM abuse is widespread throughout North Carolina. PBM abuse tactics, such as exorbitant DIR fees and clawbacks, spread pricing, decreased reimbursement, and forced mail order were reported by over half of the surveyed participants. Of surveyed participants, 100% admitted to being negatively affected by PBMs and support PBM reform in our state.

The NCPA conducted a larger survey that assesses pharmacists’ perceptions of PBMs. A key finding was that “58% of respondents say based on current prescription reimbursement, they are somewhat likely or very likely to close their doors in the next two years.” Additionally, 63% of respondents agree that DIR fees are the biggest challenge confronting community pharmacy. (7)

Our study had several limitations. Due to its small sample size (n=33), with varying participation per question, an additional survey with increased participation will provide more insight to the impact PBMs have on independent pharmacies and patients in North Carolina.

Additionally, the questions asked in the survey were largely subjective. Finally, it is difficult to verify the legitimacy of participants’ identifications as the survey was distributed through the NCAP email listserv and social media sites.

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In 2021, 42 states introduced over 100 bills in an attempt to regulate PBMs and add transparency to their business practices. Providing evidence to support the passing of these bills is crucial, and our survey represents a great start on the compilation of data for the state of North Carolina. Our evidence suggests that ethically questionable PBM practices have negatively impacted pharmacies and patients in North Carolina.

Through the data and submissions from the survey, NCAP lobbyist, Tony Solari, PhD was able to advocate and provide evidence to support the passage of the North Carolina PBM Bill, which was signed into law on September 20, 2021. (8) This Bill aims to increase price transparency for patients and pharmacies and ensures regulation and licensure of PBMs in North Carolina.

While the Bill is not as robust as originally written, it is a great first step for our state to begin curtailing the negative effects of PBMs for our patients and pharmacies.

Authors: Rebecca Lee, PharmD Candidate, Class of 2023, Campbell University College of Pharmacy, (rslee0813@email.campbell.edu); Beth Mills, PharmD, BCACP, CDCES, CPP, Clinical Associate Professor, Campbell University, Department of Pharmacy Practice, Clinical Pharmacist Practitioner, Benson Health, Director, PGY2 Ambulatory Care Pharmacy Residency, Katie Trotta, PharmD, BCACP, Clinical Associate Professor, Campbell University, Department of Pharmacy Practice, Manager, Campbell University Health Center Pharmacy, Director, PGY1 Community-Based Pharmacy Residency, and M. Ryan Brownlow, PharmD Candidate, Class of 2022, Campbell University College of Pharmacy

6. PBM Abuses; National Community Pharmacists Association https://ncpa.org/sites/default/files/2020-12/pbm-business-practices-one-pagers.pdf 7. NCPA; NCPA Survey: Health of Independent Pharmacists http://www.ncpa.co/pdf/survey-health-cp.pdf 8. North Carolina General Assembly; Senate Bill 257 - Medication Cost Transparency Act S257v3.pdf (ncleg.gov) 9. PBM Basics; Pharmacists Society of the State of New York, Inc. https://www.pssny.org/page/PBMBasics 10. Executive Order 14036; https://www.govinfo.gov/content/pkg/FR-2021-07-14/pdf/2021-15069.pdf 11. HHS Drug Pricing Plan; https://aspe.hhs.gov/sites/default/files/2021-09/Drug_Pricing_Plan_9-9-2021.pdf 12. Drug Topics; Independents prepare to close up shop https://www.drugtopics.com/view/independents-prepare-close-shop 13. Montana Free Press; States step up push to regulate pharmacy drug brokers https://montanafreepress. org/2021/06/30/states-regulate-pharmacy-benefit-managers/ 14. 46brooklyn; Inside the wild universe of prescription drug markups https://www.46brooklyn.com/research/2018/10/4/inside-the-wild-world-of-prescriptiondrug-markups-bz556

References:

NCAP supports various practice academies, forums, networks, committees, task forces, and special project

teams. Click here to fill out a form for committees and/ or projects you would be interested in serving on. Indi-

1. Tung, L. (2021, February 12). The hidden players putting independent pharmacies out of business. Retrieved September 27, 2021, from https://whyy.org/segments/the-hidden-players-putting-independent-pharmacies-out-of-business/ 2. PBM Abuses; Community Oncology Alliance https:// pbmabuses.org/ 3. American Patients First - The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs; The U.S. Department of Health & Human Services https:// www.hhs.gov/sites/default/files/AmericanPatientsFirst.pdf 4. The Enquirer; Ohio ends pharmacy middlemen contracts over ‘spread pricing’ https://www.cincinnati.com/story/ news/2018/08/14/ohio-ends-pharmacy-middlemen-contracts-over-spread-pricing/993354002/ 5. Rutledge v. Pharmaceutical Care Management Assn.; Supreme Court of the United States https://www.supremecourt.gov/opinions/20pdf/18-540_m64o.pdf?fbclid=IwAR0xOVqHdlb54HJjlP2Am7vo59TyHQ12cBSP5xMimlqCP2MeLv5SqV_JjWI

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cating more than one area of interest helps us better ensure that we can place most, if not, all volunteers.

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New Drug

Leqvio® (inclisiran)

By: Amber Hill, PharmD Candidate Breana Blue, PharmD Candidate Dr. Adrienne Bundrick Manufacturer: Novartis Pharmaceuticals Corporation Classification: Antilipemic Small Interfering Ribonucleic Acid (siRNA) Agent

Absorption

FDA Approval: December 22, 2021

Indication (1): Approved as adjunct therapy to diet and maximally tolerated statin for the treatment of heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease (ASCVD) in adults who require additional low-density lipoprotein cholesterol (LDL-C) lowering.

Contraindications: None Pharmacology (1,2):

LDL-C receptor recycling and expression, resulting in increased LDL-C uptake and elimination from the blood.

Pharmacokinetics (1,2):

Inclisiran is a small interfering ribonucleic acid agent. It is taken up by the hepatocytes, where it acts on proprotein convertase subtilisin kexin type 9 (PCSK9) by causing interference and catalytic breakdown of PCSK9 mRNA. PCSK9 is responsible for LDL receptor degradation. By interfering with PCSK9, inclisiran increases

Inclisiran reaches peak plasma concentrations roughly 4 hours after a single subcutaneous administration with an average Cmax of 509 ng/mL. After 24-48 hours, plasma concentrations are undetectable. The mean area under the curve was 7980 ng*h/mL. Distribution

Inclisiran is 87% protein bound, and the volume of distribution after a single subcutaneous dose of 284 mg is approximately 500 L. There is high selective uptake of this medication into the liver.

Metabolism

Inclisiran is primarily metabolized by nucleases and is not a substrate of CYP450 or transporters.

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Elimination

The elimination half-life of inclisiran is roughly 9 hours, and approximately 16% is renally cleared. Accumulation does not occur with multiple dosing.

Drug Interactions (1):

No formal clinical studies evaluating drug interactions have been conducted. Inclisiran has not been found to be a substrate, inhibitor, or inducer of any cytochrome P450 enzymes or transporters, and no drug-drug interactions are anticipated to occur.

Adverse Effects (1,2):

The most common adverse effects based on clinical trials are injection site reaction (8%), antibody development (5%), arthralgia (5%), and respiratory bronchitis (4%).

Dosing and Cost (1,2):

Inclisiran is an injectable solution that is available at a strength of 284 mg/1.5 mL (189 mg/mL) in a single-dose prefilled syringe. The cost of inclisiran is not available.

A dose of 284 mg should be administered as a single subcutaneous injection at initiation of therapy, at 3 months, and then every 6 months thereafter. The abdomen, upper arm, and thigh are all appropriate injection sites. If a dose is missed by <3 months, inclisiran can be administered, and the original dosing schedule should be maintained. If a dose is missed by ≥3 months, the dosing schedule should be restarted. No dosage adjustments are necessary for hepatic or renal impairment.

Clinical Efficacy (3-4):

The ORION-9 clinical trial was conducted to evaluate the use of inclisiran for treatment of HeFH. This was a phase 3, randomized, double-blind, placebo-controlled trial that was conducted at 46 sites in 8 different countries. Patients eligible for enrollment in this trial included those aged 18 years and older with a diagnosis of HeFH. They had to have an LDL-C ≥ 100 mg/ dL while being on the maximum tolerated dose of a statin, as well as a fasting triglyceride level <400 mg/ dL at screening. Patients who were not on statin therapy had to have failed treatment at all doses of at least 2 statins due to intolerance. Those on lipid-lowering therapies, such as statin and ezetimibe, had to be on a stable dose ≥30 days before screening. Some criteria

for exclusion included major cardiovascular events within the 3 months prior to randomization, New York Heart Association (NYHA) class IV or last known left ventricular ejection fraction <25%, uncontrolled severe hypertension, severe concomitant non-cardiovascular disease that has the risk of reducing life expectancy to <2 years, pregnancy and lactation, unwillingness to use acceptable method(s) of contraception, and treatment with PCSK9 monoclonal antibody within 90 days of screening.

A total of 482 patients were randomized in a 1:1 ratio to receive inclisiran sodium 300 mg or matching placebo, both of which were administered as a 1.5 mL subcutaneous injection. Patients received injections on day 1, 90, 270, and 450. Additionally, they attended clinics on day 30, 150, 330, and 510 to assess fasting biochemical measurements and the safety of inclisiran. Baseline characteristics were similar between the 2 treatment groups, with the exception of PCSK9 levels which were approximately 23 µg/L higher in the inclisiran group.

The mean baseline LDL-C level was 153 mg/dL. A total of 90% of patients were on background statin therapy, including 75% of which were receiving a high-intensity statin. Over 50% of patients were also being treated with ezetimibe.

The primary endpoints were the percent change in LDL-C levels from baseline to day 510 and the time-adjusted percent change in LDL-C from baseline between day 90 and day 540. The secondary endpoints included the mean absolute change in LDL-C from baseline to day 510, the time-adjusted absolute reduction from baseline between days 90 and 540, and the changes in PCSK9, total cholesterol, apolipoprotein B, and non-high-density lipoprotein (HDL) cholesterol. In this trial, it was found that inclisiran significantly reduced LDL-C levels when compared to placebo. From baseline to day 510, there was a 39.7% decrease in LDL-C in the inclisiran group versus an 8.2% increase in the placebo group. This resulted in a between-group difference of -47.9 percentage points in LDL-C levels (p<0.001).

Between day 90 and day 540, there was a 38.1% decrease in LDL-C in the inclisiran group compared to a 6.2% increase in the placebo group, which resulted in a between-group difference of -44.3 percentage points in LDL-C (p<0.001). These significant LDL-C reductions were observed greatest among those who were receiving therapy with both a high-intensity statin and ezetimibe. Additionally, it was found that there was a 60.7% decrease in PCSK9 levels among those in the inclisiran group compared to a 17.7% increase in the placebo group, which resulted in a -78.4 percent difference between the two groups (p<0.001).

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In this clinical trial, genetic sequencing was performed for the four genes (LDLR, APOB, PCSK9, and LDLRAP1) that account for most cases of familial hypercholesterolemia. Of the 432 patients who consented to genetic testing, 73.4% were found to have variants for familial hypercholesterolemia. The LDLR gene, which was grouped as either pathogenic, probably pathogenic, and uncertain significance, was found in 80.8% of these patients. Of those patients with the LDLR gene, 90.2% had the pathogenic variants, and it was found that these patients had the highest mean baseline LDL-C levels.

The most common adverse events that occurred during the clinical trial were nasopharyngitis, injection site reaction, and back pain. Injection site reactions occurred more in the inclisiran group (17% vs 1.7%), and 90.2% of those incidences were classified as mild.

Overall, the results of this study show that inclisiran is a safe and effective add-on therapy for the treatment of HeFH.

The ORION-10 trial was a randomized, double-blind, placebo-controlled, parallel-group, phase-3 trial. The objective was to assess the safety and efficacy of inclisiran over an 18-month period in patients at high risk for cardiovascular disease and despite maximum tolerated statin therapy. The maximum tolerated dose was defined as the maximum dose a patient could take on a regular basis without severe adverse events. The trial was conducted in the United States and included adults with atherosclerotic cardiovascular disease with LDLs of 70 mg/dL or greater. Randomization was stratified based on the background use of statins in a 1:1 ratio with each group receiving 284 mg (1.5 mL). Placebo or inclisiran was given on days 1, 90, 270, and 450. Clinical follow-up was conducted on days 30, 150, 330, and 510. The trial was conducted until day 540.

The co-primary endpoints were change in LDL cholesterol level from baseline to day 510 and time adjusted percentage change from baseline after day 90 to day 540 with peak/trough measurements accounted for. Secondary endpoints included absolute change, time-adjusted change in LDL cholesterol level from baseline, change from baseline to day 510 for levels in PCSK9, total cholesterol, apolipoprotein B, and nonHDL cholesterol. Confirmatory assays minimized the risk of false negative results. The primary endpoints were analyzed with an analysis of covariance model and the secondary endpoints was analyzed with a mixed model for repetitive measures.

The trial screened 2329 patients and included 1561

with 781 assigned to inclisiran and 780 to placebo. The average age was 66 years with about 69% male and 85% white race. All patients had ASCVD, about 90% had hypertension, and about 44% had diabetes. At day 510, the percentage change in LDL cholesterol levels was 1% in the placebo group and -51.3% in the inclisiran group. The between-group difference was -52.3% (95% CI, -55.7 to-48.8; p<0.001). The time-adjusted change in LDL cholesterol level after 90 days to day 540 compared to the baseline was 2.5% in the placebo and -51.3% in the inclisiran group. The between-group difference was -53.8% (95% CI, -56.2 to-51.3; p<0.001).

The key secondary endpoint of the percent change at day 510 was 13.5% with placebo and -69.8% with inclisiran, a between-group difference of -83.3% (95% CI, -89.3 to -77.3; p<0.001). Adverse events were similar between groups, which were reported as 73.5% receiving inclisiran and 74.8% receiving placebo. These adverse events were due to any cause, not exclusively treatment-related. Anti-drug antibodies were detected in 2% of the samples from inclisiran treated patients.

The findings were consistent with the assay specifications but not drug induction. The anti-drug antibodies were similar in pretreatment and post-treatment samples. Serious adverse events were reported in 22.4% of patients in the experimental group and 26.3% in the placebo group. These included 12 deaths in the inclisiran group and 11 in the placebo group.

The ORION-11 trial had the same design and methods as the ORION-10 trial with slight differences. ORION-11 was conducted in Europe and South Africa and included adults with atherosclerotic cardiovascular disease or an atherosclerotic cardiovascular disease risk equivalent, defined as type 2 diabetes mellitus, ASCVD 10-year risk of 20% or greater, or familial hypercholesterolemia. Patients with ASCVD were required to have a LDL of 100 mg/dL or higher. Randomization was not only stratified by the statin but also according to country. There were 2381 patients screened, and of those, 1617 were randomized. A total of 810 patients were randomized to the inclisiran group and 807 patients were randomized to the placebo group. Unlike in the ORION-10 trial, the average percentage of patients with ASCVD was about 87.5% and was about 12.5% in those with ASCVD risk .

There were fewer patients with diabetes and hypertension than the ORION-10 trial. Majority of patients were on high intensity statins, 78.6% in the ORION-11 trial compared to 68% in the ORION-10 trial, and overall statin therapy was 94.7% and 89.2% respectively. At day 510, the percentage change in LDL cholesterol levels was 4% in the placebo group and -45.8% in the inclisiran group. The between-group difference was

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-49.9% (95% CI, -53.1 to-46.6; p<0.001). The time-adjusted change in LDL cholesterol level after day 90 to day 540 compared to the baseline was 3.4% for the placebo group and -45.8% for the inclisiran group. The between-group difference was -49.2% (95% CI, -51.6 to-46.8; p<0.001). The key secondary endpoint of the percent change at day 510 was 15.6% with placebo and -63.6% with inclisiran, with a between-group difference of -79.3% (95% CI, -82 to -76.6; p<0.001).

Adverse events were reported in 82.7% receiving inclisiran and 81.5% receiving placebo. Anti-drug antibodies were detected in 2.5% of the samples from inclisiran treated patients. Serious adverse events were reported in 22.3% of patients in the inclisiran group and 22.5% in the placebo group. These included 14 deaths in the inclisiran group and 15 in the placebo group.

In conclusion, the ORION-10 and ORION-11 trails collective demonstrated using inclisiran injections on day 1, 90, and then every 6 months reduced LDL cholesterol levels 49.9% to 52.2% at month 17 and lowered time adjusted LDL cholesterol levels between months 3 and 18 by 49.2% to 53.8% as compared with placebo. Patients receiving inclisiran had decreased PCSK9 levels, in contrast to increased PCSK9 levels in patients receiving placebo. With both trials, the adverse event profile was similar in both study groups. Most adverse reactions were mild to moderate, and ongoing open-label extension studies will provide additional long-term safety follow-up information. These trials ultimately demonstrated inclisiran injections every 6 months significantly reduced LDL cholesterol levels by approximately 50%.

Pregnancy and Lactation (1):

There is a lack of data to support the safety of inclisiran in pregnancy; therefore, inclisiran should be discontinued if a patient becomes pregnant. This medication has the potential to cause fetal harm based on the mechanism of action. Since it works to decrease LDL-C in circulation, it may also reduce other important biologically active substances derived from cholesterol that are necessary for normal fetal development. However, animal reproduction studies have not shown that inclisiran causes adverse effects on fetal development. One study found no embryo-fetal developmental toxicities during organogenesis after maternal exposure to inclisiran doses up to 5-10 times the maximum recommended dose for humans.

There is a lack of data concerning the presence of inclisiran in human milk and the effects it may have on

an infant or milk production. Animal studies found that inclisiran was present in milk at mean maternal plasma:milk ratios between 0.361 and 1.79. However, there was no evidence of systemic absorption in the suckling offspring.

Storage (1): Inclisiran should be stored at room temperature between 20°C and 25°C (68°F and 77°F); excursions are allowed between 15°C and 30°C (59°F and 86°F).

Summary/Use in Clinical Practice (1-5):

The 2018 American College of Cardiology (ACC)/American Heart Association (AHA) cholesterol guidelines recommend statins as first-line therapy for all patients requiring management of elevated LDL-C levels. Other therapies, such as ezetimibe, bile acid sequestrants, and PCSK9 inhibitors, may be added to maximally tolerated statin therapy if patients require additional LDL-C lowering.

Inclisiran is a newly approved lipid-lowering therapy that has been found to be safe and effective as add-on therapy for HeFH and ASCVD. It is the first siRNA agent available for use in those with HeFH or ASCVD who need additional LDL-C lowering, and it is indicated as adjunct therapy to diet and a maximally tolerated statin.

Inclisiran works by interfering with the translation of the PCSK9 protein, thereby decreasing its production, which causes a reduction in LDL receptor degradation, thereby increasing the amount of LDL receptors available for LDL-C uptake. This medication is somewhat similar to PCSK9 inhibitors, which increase the number of LDL-C receptors available by inactivating PCSK9.

PCSK9 inhibitors are also indicated for use in ASCVD and HeFH but are currently considered last-line, with cost being a primary concern. Comparatively, statins are a more affordable treatment option for patients and are effective in lowering LDL-C levels.

The 2018 ACC/AHA cholesterol guidelines have not been updated to include inclisiran treatment recommendations; however, there are a few factors that may be taken into consideration. First, compared to PCSK9 inhibitors, inclisiran offers practical benefit in reduced frequency of administration. Second, although cost data is not yet available for inclisiran, this may help to further determine its place in therapy when it becomes available. Lastly, although there is currently no data regarding the effects of inclisiran on cardiovascular events, such as MI or death, this will be assessed in the ongoing ORION-4 clinical trial and will also be helpful in establishing its place in clinical practice. Future

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studies are planned to evaluate the efficacy of inclisiran, including studies of its use in adolescents with HeFH and patients with homozygous familial hypercholesterolemia (HoFH).

Inclisiran should be administered subcutaneously in the abdomen, upper arm, or thigh. A dose of 284 mg should be given at initiation, at 3 months, and every 6 months thereafter. If a dose is missed by <3 months, inclisiran may be administered and the original dosing schedule resumed. However, if it is missed by ≥3 months, the dosing schedule should be restarted. No dosage adjustments are necessary in patients with hepatic or renal impairment. Pregnant individuals should not receive treatment with inclisiran as this drug may cause fetal harm. Additionally, lactating mothers should avoid inclisiran therapy due to the lack of data regarding its presence in milk, effects on milk production, and effects on infants. The safety and efficacy of inclisiran has not been investigated in the pediatric population. The most common adverse effects observed with inclisiran are injection site reaction, antibody development, arthralgia, and respiratory bronchitis.

Authors: Amber Hill, PharmD Candidate, Class of 2022, Campbell University College of Pharmacy & Health Sciences (amhill0327@email.campbell.edu); Breana Blue, PharmD Candidate, Class of 2022, Campbell University College of Pharmacy & Health Sciences ; and Adrienne Bundrick, PharmD, BCPS, Cape Fear Valley Medical Center The authors have no conflicts of interest to disclose.

References:

1. Inclisiran (Leqvio®). Package insert. Novartis Pharmaceuticals Corporation; 2021.

2. Inclisiran. Lexi-Drugs. Lexicomp [database online]. Hudson, OH: Lexicomp, Inc. http://online.lexi.com. Updated 2021.

Accessed October 14, 2021.

3. Raal FJ, Kallend D, Ray KK, et al. Inclisiran for the treatment of heterozygous familial hypercholesterolemia. New England Journal of Medicine. 2020;382(16):1520-1530.

4. Ray KK, Wright RS, Kallend D, et al. Two Phase 3 Trials of Inclisiran in Patients with Elevated LDL Cholesterol. N Engl J Med. 2020;382(16):1507-1519. doi:10.1056/NEJMoa1912387 5. Grundy SM, Stone NJ, Bailey AL, et al. 2018 aha/acc/ aacvpr/aapa/abc/acpm/ada/ags/apha/aspc/nla/pcna guideline on the management of blood cholesterol: a report of the american college of cardiology/american heart association task force on clinical practice guidelines. Circulation.

2019;139(25).

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Free For NCAP Members Have you ever: Wanted to offer more to your patients at risk for diabetes?

Thought about providing diabetes prevention education in your pharmacy or community?

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All Hands on Deck: The Integral Role of Pharmacy in Developing a Mass COVID-19 Vaccination Program By: Dr. Jessica Stickel Dr. Lisa Edgerton Dr. Holly Snider Dr. Michael J. Melroy Abstract One of the many challenges of the COVID-19 pandemic has been the effective distribution of vaccines.

This article discusses the pharmacy department’s leadership role in COVID-19 vaccination efforts at Novant Health New Hanover Regional Medical Center and suggests a strategy for broad implementation of vaccination clinics using a scalable model. The paper also focuses on health equity in the distribution of the vaccine, the use of pharmacy learners in the vaccination efforts, and the need for teamwork throughout the health system.

Introduction

The coronavirus disease 2019 (COVID-19) pandemic has caused a dramatic shift in how both patients and health systems approach healthcare. COVID-19 was officially declared a pandemic by the World

Health Organization on March 11, 2020, and multiple vaccine candidates entered development. (1,2) As trials were conducted and successful vaccines expected, the impetus fell to government and healthcare leaders to determine how to distribute and administer the vaccines. (2) Mass vaccination campaigns have been implemented to help manage infectious diseases throughout history, but none have involved the scale and complexity of COVID-19 vaccination. (3,4) One of the most successful historical mass vaccination efforts in the United States involved polio vaccines, but much of that effort focused on delivery to children in schools using an oral vaccine. (5,6) During the 2009 H1N1 influenza pandemic, difficulties with distributing vaccines to the public showed that improved infrastructure would be necessary for the future. (7) In subsequent studies of mass vaccination efforts, most institutions were found to be withPage 29

out the appropriate preparation and resources needed to execute mass vaccination programs. (4) Thus, efforts to implement successful mass vaccination campaigns for COVID-19 around the country would require innovation by government, health system, and community leaders.

At Novant Health New Hanover Regional Medical Center, pharmacy leadership was chosen to serve a primary role in developing the mass vaccination program. Multiple objectives drove the development of the vaccination program, with the primary purpose being to vaccinate the community safely and efficiently.

An internal goal of the program was to create a sustainable model that would allow the pharmacy team to support the evolving vaccination efforts while maintaining patient care and operations. Key external goals were to provide a positive patient experience, ensure equity in the distribution of vaccines, and educate

the community about COVID-19 vaccination. Equitable distribution focused on historically marginalized populations, and vaccine education was targeted to people most likely to be adversely affected by the virus or to have vaccine hesitancy.

Our institution was uniquely positioned as the main healthcare system in the Wilmington, North Carolina area, making us a major supplier of vaccines for the general public and surrounding counties. Although the pharmacy team had been involved in smaller seasonal vaccination events, including drive-thru influenza vaccinations, coordinating the logistics to vaccinate thousands of people against COVID-19 efficiently required innovation and teamwork. The entire pharmacy department came together with an attitude to support this initiative, with pharmacists, technicians, residents, students, and non-clinical staff engaging in roles to support the vaccination effort. The pharmacy team was involved in planning and leading clinics, procuring, and storing vaccines to maintain the cold chain, preparing vaccines onsite, vaccinating patients, documenting vaccinations in the online portal, answering clinical questions at vaccination clinics, educating employees and the greater community at large, and engaging in non-clinical duties including labeling and preparing supplies. Ultimately, the defining feature of the vaccination program proved to be the development of a scalable clinic model. This allowed for operating clinics that could be adapted to provide care in multiple locations depending on the need for more significant mass vaccination events or more targeted outreach initiatives.

Initial Stages

In early November 2020, it was anticipated that the first COVID-19

vaccine would soon become available in the United States. Leadership at our institution identified a COVID-19 Vaccine Operations Team to begin planning a vaccination program, with pharmacy management in a leadership role. Initially, pharmacy leaders collaborated with a small interprofessional team to plan the logistics for an employee vaccination clinic. In December, the COVID-19 Vaccine Operations Team expanded to include additional departments, and the director of pharmacy began working in partnership with a director of clinical excellence to manage the team. The partnership with clinical excellence allowed for further progress toward program goals, as the mission of the clinical excellence department is to implement standardization and optimize clinical practices to best standards.

The employee vaccination clinic was established in an unused, low-traffic wing of the hospital. This dedicated space for the clinic allowed for a focus on the program goals of safety and creating a positive patient experience, as the easy access and open space to monitor patients created a comfortable environment. This clinic served as the model for the vaccination program to replicate and scale up or down for future vaccine administration to the community.

The early days of operation at the employee vaccination clinic provided the team with insight into opportunities to optimize the mass vaccination program. Lean methodology was used in the planning approach, and the plan-do-check-act method allowed for adapting the vaccination program after each new idea was implemented. (8) Standard work documents were created to optimize the clinics’ safety and efficacy and ensure a systematic experience for staff each day. Video interpreting services were made available at each clinic to ensure equity in the experience. The path through the vaccinaPage 30

tion clinic was arranged to minimize wait time, with multiple check-in stations to keep the line flowing. The structure of the vaccination clinic and layout at the hospital site is shown in Figure 1.

Initially, pharmacy managers and a select group of hospital pharmacists were the only pharmacy team members involved in the employee vaccination clinic. The roles of the pharmacy team at this time included:

• Managing vaccine storage and supply.

• Preparing all vaccine doses during the clinic.

• Answering clinical questions from patients.

Vaccines were prepared according to patient volume and observed needs throughout each clinic day to prevent waste and ensure efficient use of resources. After staffing the vaccination clinics for a few weeks, it became clear that it was not feasible for this small group of pharmacists to maintain their usual work duties while being responsible for the vaccination clinics. The decision was made to expand the pharmacy team members involved and train pharmacy residents to complete some of the tasks previously completed by pharmacy managers, including procuring vaccine supplies and managing the number of doses prepared during the clinic day. Resident involvement in COVID-19 vaccination clinics was formalized into a longitudinal learning experience and evaluated quarterly. As vaccination clinic volume increased, pharmacy students were also integrated into the clinic longitudinally, in a staffing model that ensured no more than one to two shifts per week.

By scheduling pharmacy residents and students in longitudinal roles, disruption of traditional rotation responsibilities was limited, and

preceptors were able to incorporate vaccination clinic staffing into the overall rotation experience. Pharmacy students and residents expressed positive feedback about their involvement in vaccination clinics, indicating that it provided a unique opportunity to impact the community and be part of the solution to the pandemic.

Expansion

In January 2021, state guidelines allowed for community vaccination of the elderly population. The employee vaccination site was then opened to qualifying community members, and the entire pharmacy department was invited to become involved in the vaccination clinics.

Clinic workflow was optimized for patients with limited mobility with the addition of a drive-up option.

New standard work documents were developed to communicate all vaccine preparation steps for pharmacy staff, and meetings were held to ensure education on clinic processes. As the vaccination effort transitioned from a focus on vaccinating employees to vaccinating the community, the lack of space for a large-scale mass vaccination clinic at the hospital site was identified as a barrier. The COVID-19 Vaccine Operations Team began identifying potential alternate locations to offer community mass vaccinations and exchanged ideas with leaders from other health systems in the state to identify best practices. A centrally located movie theater was identified, and the successful clinic structure operating at the hospital clinic was scaled up to fit the new location.

Twelve vaccination stations were set up in the theater’s lobby, with the drive-up vaccination option also offered. Flow through the vaccination clinic mirrored the hospital clinic.

Patients moved through a check-in line to their vaccination station and then to the fifteen-minute observa-

tion area with chairs along a hallway and inside one of the theaters. A staff break room was transformed into the pharmacy work area, with the addition of a pharmacy refrigerator for storing daily vaccine supply and tables to prepare syringes.

The community location operated simultaneously with the hospital clinic through April, allowing for vaccination of large numbers of people. This setup also meant coordinating staff between different roles at the two clinics, and additional pharmacist leadership roles were developed. Three pharmacists were identified as scheduling coordinators, and a lead pharmacist position was created for each shift.

Pharmacy residents typically filled the lead pharmacist position at the hospital clinic and were responsible for coordinating logistics, managing the number of doses prepared, and answering clinical questions from patients. Additional pharmacy team members prepared syringes and ensured distribution to vaccination stations, and pharmacists were added to fill vaccinator positions. As state guidelines continued to open and allow vaccinations for the general public, clinics grew, and pharmacy team collaboration with other healthcare professionals increased.

Adapting to Challenges

The vaccination documentation process became a challenge to efficient workflow as clinic volume increased. Documentation of vaccine administration into the state vaccine management portal was essential for clinic operations beyond record-keeping, as future vaccine allocation depended on records that proved previous shipments had been depleted. Pharmacy team members, especially pharmacy students, spent a significant amount of time transferring written documentation into the online state portal, as Page 31

the documentation in the electronic medical record did not automatically transfer to the state portal. To overcome this barrier, the information technology team worked with the state to create an automated process that would allow for documentation in the electronic medical record to transfer into the state management portal. This allowed pharmacy students and other team members to be reassigned from their documentation roles to help in other areas.

With clinic locations open for vaccination, vaccine hesitancy and difficulty getting vaccinations to historically marginalized populations were additional obstacles to overcome. Vaccination program leadership engaged in targeted efforts to educate vulnerable populations and make vaccines more accessible in these communities. Developing partnerships with respected community leaders, including those in faith-based organizations, was essential in overcoming this barrier.

After community leaders provided information, it could be relayed to the larger population with a greater sense of trust. A pharmacy resident developed educational materials to share with the community and helped lead outreach initiatives to overcome vaccine hesitancy. When available, pharmacists who were culturally aligned with a vulnerable community delivered the education to build trust. Small group sessions were used to encourage asking questions in a comfortable atmosphere. Pharmacists participated in video conferences and sessions on various social media platforms to further educate the public, and sessions were offered with interpreters to reach a wider audience. Appointment scheduling was also offered in conjunction with educational sessions to increase equity and minimize barriers to vaccination.

Vaccination clinics for specific

populations were conducted to reach those encountering barriers to attending the regularly scheduled mass vaccination clinics at the hospital and movie theater. A safe space clinic was held for the LGBTQ+ community, and Spanish-speaking clinic days were designated for the Latinx community. Outreach events were held at a variety of community sites, including faith-based organizations, business partnerships, and community centers to reach historically marginalized populations and bring services to patients in their community. In partnership with the local health department and to help return children to schools more quickly, a vaccination clinic for teachers was set up with extended hours to allow for more convenient vaccination. For homebound patients experiencing transportation barriers, a process was developed to enable community paramedics and home health nurses to pick up a pre-specified number of vaccines from the hospital vaccination clinic to administer on their home visits.

An inpatient option was implemented to allow for vaccines to be administered to patients awaiting hospital discharge based on patient criteria and requested further increase convenience. An inpatient pharmacist team directed the inpatient vaccination option, and the pharmacy team was heavily involved in the planning and execution of the outreach efforts.

Program Outcomes

Operation of the hospital vaccination clinics ended in November 2021, as community access to vaccines had increased, and the focus had shifted to providing vaccines in local pharmacies and outpatient physician offices. From December 2020 through November 2021, 114,247 COVID-19 vaccines were administered during 290 vaccination clinics. The number of vaccines

administered peaked in February 2021, with 28,167 vaccinations (Figure 2). Ten outreach clinics were completed at community locations in partnership with local businesses, and 44 off-site clinics were completed for historically marginalized populations. The demographics of vaccine recipients were similar to the population demographics of the three counties in our institution’s service area based on the United States Census Bureau 2019 five-year estimates (Table 1). (9)

Schedules for vaccination clinics were not made available to the public until confirmation of vaccine allotment was received, so no patient appointments had to be canceled due to lack of vaccine supply. Of 2,054 patients who answered a post-vaccination survey, 99.29% indicated they had a positive experience. Survey comments were overwhelmingly positive and frequently referenced the clinics’ friendly atmosphere, efficiency, and organization. The estimated time for one patient to move through the clinic, from intake to completing their 15 minutes of observation time, was about 20 minutes. During peak vaccine demand, an average of 90 patients were vaccinated per hour at the original hospital-based clinic, and 180 patients were vaccinated per hour at the larger off-site community vaccination clinic. As clinic volume increased, clinic staff was expanded to incorporate volunteers and retired physicians, nurses, and other healthcare providers in a 1:3 ratio of hospital-based staff to community volunteers (Table 2).

From December 2020 through November 2021, the pharmacy department staffed a total of 7,925 hours in COVID-19 vaccination clinics, with student pharmacists staffing 37.5% of hours and pharmacy residents staffing 17.2%. The 3,590 hours (45.3%) staffed by traditional pharmacy staff ranged from 0.8 of a Page 32

full-time equivalent (FTE) in December to 11.4 FTEs in February, when vaccinations peaked.

Patient care opportunities were greatly expanded by pharmacist involvement in the vaccination clinics. The pharmacy team participated in all steps of the vaccination process, from vaccine preparation, counseling patients at the clinic, vaccinating patients, and initially, to documenting vaccinations in the online record. Pharmacists’ ability to be involved in all aspects of the vaccination process helped show the value of pharmacy and allowed for flexibility in clinic operation. Pharmacists could move between preparing doses, educating, vaccinating, and documenting – wherever help was needed to make the clinic run more smoothly.

Reflection

As the only major health system in southeastern North Carolina, our institution’s responsibility was to support public health and provide COVID-19 vaccinations to the larger community. Creating and implementing a process for mass COVID-19 vaccination took collaboration, innovation, and perseverance by all those involved. Pharmacy was integrated into the initial planning of the vaccination program, with pharmacists successfully managing all aspects of the health-system clinics and demonstrating the value of pharmacy beyond traditional practice settings. Versatile roles were available for pharmacists, technicians, residents, students, and support staff to fill, and anyone who wanted to volunteer could find an opportunity. Throughout the operation of the vaccination clinics, pharmacists demonstrated their ability to re-organize roles to meet new needs and participated directly in institution-level goals.

The defining feature of the vaccination program proved to be the development of a sustainable clinic model that could be scaled up or down to fit multiple locations according to community needs. This innovative approach allowed for swift adaptability to changing needs and success in vaccinating thousands of people both safely and efficiently. With the scalable clinic model and pharmacist participation in community education, we pursued equity in distributing information and vaccines. Patient feedback was overwhelmingly positive, and the pharmacy team managed to create a staffing model that allowed for participation in vaccination clinics while still maintaining usual staffing roles.

Participation in vaccination clinics also helped promote the well-being and resiliency of staff. It enabled team members to be part of the solution to the pandemic and directly impact patient care while seeing the impact of the virus full circle. Through participation in the vaccination clinics, pharmacist interaction with other disciplines and the larger pharmacy team was expanded. The pharmacy team worked in direct partnership with nursing, emergency management, information technology, hospital police, physicians, volunteers, and the local health department to operate and coordinate the clinics. Silos were removed, and team members collaborated with colleagues they would not have otherwise met due to differing job responsibilities. Inpatient pharmacists working at vaccination clinics were staffing alongside outpatient pharmacists and those in non-clinical roles, which allowed all employees to work together as one united pharmacy team.

Conclusion

Implementation of the mass vacci-

nation program led to almost 300 vaccination clinics conducted from December 2020 through November 2021. Nearly 115,000 vaccinations were given, with the percent of vaccinations for historically marginalized populations approaching the overall population’s demographics.

The initiative’s success depended on many factors, including pharmacist participation in vaccination program leadership and the flexibility of pharmacists to fill multiple roles at clinics to keep workflow running smoothly. In addition, the attitude and involvement of the entire pharmacy department to support this effort allowed for a consistent supply of staff for clinics and an understanding that priorities would shift to make the vaccination program a success. Most importantly, the method of creating a sustainable, scalable clinic model for mass vaccination is what sets this initiative apart. The vaccination clinic model was created to be adapted for emerging community needs during the COVID-19 pandemic, but it could conceivably be duplicated for another emergency in the future. With an adaptable, proven process for mass vaccination, our institution has created a lasting impact that can benefit patients across the country.

Authors: Jessica Stickel, PharmD, PGY2 Ambulatory Care Pharmacy Resident, Novant Health New Hanover Regional Medical Center; Jessica.stickel@nhrmc.org; Lisa Edgerton, PharmD, BCACP, BCPS; Pharmacy Residency Coordinator and Program Director, PGY2 Ambulatory Care Pharmacy Residency, Novant Health New Hanover Regional Medical Center; Holly Snider, PharmD, BCPS; Clinical Pharmacist and Program Director, PGY1 Pharmacy Residency, Novant Health New Hanover Regional Medical Center; Michael J. Melroy, Pharm.D., MHA, BCPS, FASHP; System Director of Page 33

Pharmacy, Novant Health New Hanover Regional Medical Center.

All authors have no conflicts of interest to disclose.

References:

1. Pollard CA, Morran MP, Nestor-Kalinoski AL. The COVID-19 pandemic: a global health crisis.

Physiol Genomics. 2020;52(11):549557.

2. Sharma O, Sultan AA, Ding H, et al. A review of the progress and challenges of developing a vaccine for COVID-19. Front Immunol.

2020;11:585354.

3. Grabenstein JD, Nevin RL. Mass immunization programs: principles and standards. Curr Top Microbiol Immunol. 2006;304:31-51.

4. Hosangadi D, Shearer MP, Warmbrod KL, et al. Current state of mass vaccination preparedness and operational challenges in the United States, 2018-2019. Health Secur.

2020;18(6):473-482.

Chander J, Subrahmanyan S. Mass polio vaccination. BMJ. 1996;312(7040):1178-1179.

5. Sutter RW, Maher C. Mass vaccination campaigns for polio eradication: an essential strategy for success. Curr Top Microbiol Immunol. 2006;304:195-220.

6. Rambhia KJ, Watson M, Sell TK, et al. Mass vaccination for the 2009 H1N1 pandemic: approaches, challenges, and recommendations. Biosecur Bioterror. 2010;8(4):321-330.

7. Hallam CRA, Contreras C. Lean healthcare: scale, scope and sustainability. Int J Health Care Qual Assur.

2018;31(7):684-696.

8. 2019 American Community Survey 5-Year Estimates Data Profiles.

United States Census Bureau. Published December 10, 2020. Accessed July 1, 2021. https://data.census. gov/cedsci/

Figure 1. COVID-19 Vaccination Clinic Structure Base Model: Layout at Hospital Location

Page 34

Figure30000 2. Total COVID-19 Vaccinations Administered by Month 28167

25000

23126

Number of Vaccines

21772 20000

14723

15000

10000 6683 5000

0

3298

Dec 2020

3091

Jan 2021

Feb 2021

Ma r 2021

Apr 2021

Table 1. COVID-19 Vaccine Recipient Demographics

Total Vaccines

2143

Ma y June 2021 2021 Month

3505

July 2021

Aug 2021

Sept 2021

Oct 2021

Nov 2021

First dose n (%)

Second dose n (%)

Third dose n (%)

Total doses n (%)

58509

47318

8420

114247

47607 (81.4) 7200 (12.3) 152 (0.3) 628 (1.1) 3533 (6.0)

38763 (81.9) 5773 (12.2) 119 (0.3) 471 (1.0) 2649 (5.6)

7246 (86.1) 946 (11.2) 22 (0.3) 65 (0.8) 202 (2.4)

Age Under 12 years 12 – 18 years 19 – 44 years 45 – 64 years 65 – 74 years 75 years or older

185 (0.3) 1851 (3.2) 14365 (24.6) 14659 (25.1) 16747 (28.6) 10702 (18.3)

0 (0) 1499 (3.2) 10169 (21.5) 10647 (22.5) 15268 (32.3) 9735 (20.6)

0 (0) 3 (0.04) 1144 (13.6) 1853 (22.0) 2838 (33.7) 2582 (30.7)

Sex Male Female

2244

1019

Race* White/Caucasian Black/African American American Indian/Alaska Native Asian Other Ethnicity Not Hispanic or Latino Hispanic or Latino Other

4476

54714 (93.5) 2690 (4.6) 1105 (1.9)

24999 (42.7) 33489 (57.2)

44498 (94.0) 1874 (4.0) 946 (2.0)

19333 (40.9) 27973 (59.1)

93616 (81.9) 13919 (12.2) 293 (0.3) 1164 (1.0) 6384 (5.6)

8240 (97.9) 113 (1.3) 67 (0.8)

107452 (94.1) 4677 (4.1) 2118 (1.9)

3231 (38.4) 5189 (61.6)

47563 (41.6) 66651 (58.3)

185 (0.2) 3353 (2.9) 25678 (22.5) 27159 (23.8) 34853 (30.5) 23019 (20.1)

Demographics of the population served by our institution per the United States Census Bureau 2019 five-year estimates9 include 81% White or Caucasian, 12.6% Black or African American, 0.5% American Indian or Alaska Native, 0.77% Asian, 5.8% Hispanic or Latino, 48.5% male, 51.5% female * Patient could select multiple races; does not equal 100%

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Table 2. COVID-19 Vaccination Clinic Staffing Models Hospital-Based Clinic

Off-Site Community Clinic

Outreach Clinics

29

55

4-14*

1:3

1:3

Interprofessional Clinic Team Total Staff Vaccine Stations Employee to Community Volunteer Ratio Staffing Roles†

6

Vaccinators (6) Documenters (6) Pharmacy team (3) Operations lead (1) Clinical lead (1) Outside flow facilitator (1) Inside flow facilitator (2) Greeter (1) Check-in/registration (3) Post-vaccine monitor (2) Staff coordinator (1) EMR facilitator (1) Interpreters (0-1) Company police (1)

Pharmacy Dose Preparation Team On-Site Roles

Syringe preparation (2) Lead pharmacist: verification/ labeling (1)

12

Variable* 1:4

Vaccinators (12) Documenters (12) Pharmacy team (6) Operations lead (1) Clinical lead (1) Outside flow facilitator (2) Inside flow facilitator (4) Greeter (2) Check-in/registration (3) Post-vaccine monitor (2) Staff coordinator (1) EMR facilitators (3) EMR scheduler (2) Interpreters (0-2) Logistics/ safety officer (1) Company police (1) EMS onsite crew (2)

Vaccinators (1-4) Pharmacy team (1-2) Operations lead (1) Clinical lead (1) Flow facilitator (0-1) EMR facilitator (0-1) EMR scheduler (0-2) Interpreters (0-2)

Syringe preparation (4) Lead pharmacist: verification/ labeling (1) Distribution (1)

Syringe preparation (1) Lead pharmacist: verification/labeling/ distribution (1)

EMR: electronic medical record, EMS: emergency medical services * Variable number of staff and vaccine stations were present at outreach clinics depending on the volume expected at the events † Volunteers could fill the roles of vaccinator, documenter, flow facilitator, greeter, check-in/registration, post-vaccine monitor, and interpreter

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Page 37

Let’s Stay Connected: Improving the Connection Between Health Departments and Local Pharmacies in North Carolina By: Ashley Kelly, PharmD/MSPH Candidate

As we continue to navigate the COVID-19 pandemic, the amount of information transmitted daily can become overwhelming. Individuals receive information and updates from the news, word of mouth, even social media. Similarly, pharmacies and health departments across the state must remain informed about the everchanging information that is necessary to address the public health needs of North Carolinians.

But how is this information communicated, and more importantly, what is the process for filtering relevant information down to the local level, and how robust are the relationships between local health departments and local pharmacies?

During a pandemic or when a state public health emergency or natural disaster occurs, North Carolina has excellent macro-level communication procedures, including key stakeholders such as the North Carolina Board of Pharmacy (NCBOP). In times of an emergency, information received from the North Carolina Department of

Health and Human Services (NCDHHS) is shared with the NCBOP and publicized to North Carolina pharmacists.

NCDHHS also communicates closely with local health departments across the state. However, there is no formal localized communication process for connectivity and communication between individual health departments and pharmacies in their catchment area. These communication gaps translate into lost opportunities for synergistic relationships and healthcare resources that could strengthen local communities during times of need.

The communication breakdown has been observed throughout the opioid epidemic and during the COVID-19 pandemic on the local level. A recurring survey conducted by the Division of Public Health throughout the opioid epidemic found that many health departments could not answer the question, which local pharmacies in their area provide naloxone? Additionally, during the COVID-19 pandemic, when vaccines were first Page 38

distributed throughout the state to health departments, pharmacies searched for information about how they could receive part of the allotment. Pharmacies in the state having a strong relationship with their local health department were able to help get people vaccinated by obtaining part of their health department’s allotment. A few years ago, when the Hepatitis A outbreak happened in western North Carolina, had pharmacists been legally able to give the Hep A vaccine, our state still would have struggled to connect local pharmacies with resources on the ground.

Although our state has strong macro-level communication regarding public health needs, NCAP recognizes the need for ‘Pharmacy & Health Department Locally Integrated Communication Networks’ to improve local relationships, connectivity, and communication.

Based on the North Carolina Board of Pharmacy’s 2021 annual report, there are 1,177 chain pharmacies and 740 independent pharmacies in the state. (1) There is at least

one pharmacy in every county in North Carolina, and there are 85 local health departments serving all 100 counties. (2) NCAP has been awarded a small grant from the National Alliance of State Pharmacy Associations and the American Pharmacy Association to support establishing a network for local health departments and pharmacies in their geographic area. The project will also create a standard universal form and communication process.

We are working with the NC Association of Local Health Directors to determine the full utility of the networks and arrive at a process that will work for both the health departments and the pharmacies. In addition, NCAP plans to utilize the networks to facilitate meet-and-greet events, between local health directors and pharmacy owners or managers, within each local health district.

The next phase of the project will be to begin educating pharmacies about the network development in their area. This work will begin in April and will take several months. With the help of pharmacies across the state, NCAP believes, in time, these networks will significantly improve how public health information is shared with community pharmacies and pharmacists.

Did you know the average pharmacy prints 35 miles of paper each year?

References: 1.

2.

By using MedsOnCue you can do your part to #savetheearth. VUCA Health has been engaging with boards of pharmacy across the country and your pharmacy management system vendor to allow patients to select a new digital form of medication information, including videos. Contact us today to learn more on how you can enhance your patient engagement and minimize your printing burden.

One Hundred Fortieth Annual Report (FY 2020- 2021). North Carolina Board of Pharmacy. http:// www.ncbop.org/about/AnnualReport2020_21.pdf (Accessed: February 2, 2022).

County Health Directors. North Carolina Association of Local Health Directors. https://www.ncalhd.org/ directors/ (Accessed: February 3, 2022).

407.878.1662 | info@vucahealth.com | www.VUCAHealth.com Page 39

Ambulatory Spotlight Dr. Sarah Kokosa has been selected for NCAP’s ambulatory spotlight based on her innovative work as a clinical pharmacist practitioner with Duke Health’s Gender Medicine Clinic. new world that incorporated opportunities for pharmacists”. She began her career in ambulatory care with a focus in primary care and transitioned to Duke University Hospital’s Endocrinology Clinic in 2017.

How did you become involved in gender medicine and what does your role entail?

Tell me about your background and what sparked your interest in endocrinology.

Dr. Kokosa attended pharmacy school at the Albany College of Pharmacy in Albany, NY. During her last year of pharmacy school, her first clinical pharmacy rotation was in an endocrinology clinic. In this clinic Dr. Kokosa found her dream job, where she was “enamored by the clinical role that a pharmacist can have. The relationships and interactions with patients as well as the side by side collaboration with physicians opened up a whole

Dr. Kokosa became involved with the gender medicine clinic after approaching her endocrinology division chief about growing pharmacy clinical services. They discussed a clinical expansion that would benefit both her clinical practice and the clinic. He suggested the Gender Medicine Clinic as they were gearing up to expand and begin an initiative to become a center of excellence for gender care. He identified opportunities for research and multidisciplinary involvement including social work, endocrinology fellows and other disciplines. Dr. Kokosa found this to be a perfect fit because she feels it is “very important to support and advocate for vulnerable populations.”

In the eight months since starting in the gender medicine clinic, Dr. Kokosa has continued to have an evolving role. She finds she is best suited for “patient education regarding their hormone therapy, monitoring hormone levels and labs, and adjusting doses as needed during the process. With gender medicine, patients are seen every three months during their first year on hormone therapy.

Between visits with the physician it is helpful to have a pharmacist for those quicker visits for medication management and dose adjustments.”

In regard to gender medicine and medication management training, Dr. Kokosa worked closely with the primary gender medicine physician for several months.

She was able to see patients independently within

Page 40

three months. She also completed basic and advanced medical courses through the professional organization, World Professional Association for Transgender Health (WPATH).

What do you enjoy most about your work in the gender medicine clinic?

In describing what she enjoys most about her role, Dr. Kokosa says, “When patients begin hormone therapy it is a life changing moment for them as they start a new journey. As the pharmacist, I am usually the one teaching them how to give the injections and I am the one in the room with them when they take that first dose. It has been really rewarding to be present for that moment in their life and to celebrate them and this new journey in self-affirmation. It is a celebration and to see the relief and joy that exudes from them in that moment has been really rewarding.”

How do you feel patients have interpreted or perceived your role in their care?

Patients see Dr. Kokosa as the medication expert and somebody that they feel comfortable asking questions about their hormones, the effects that they are experiencing or potential side effects. Dr. Kokosa is introduced as the pharmacist and as the person they can go to for medication-related questions.

How have you incorporated learners into the gender medicine clinic?

When Dr. Kokosa has learners on rotation she recognizes that this is a particularly vulnerable patient population.

She “spends a lot of time with learners up front discussing etiquette such as the importance of using correct pronouns and creating a safe and respectful space. I allow them to shadow because this is often their first formal experience with this patient population. Once they feel comfortable they can become more involved with counseling on medications, injection technique and what to expect in terms of physical changes and side effects.”

What challenges have you faced in implementing a clinical pharmacist in the gender medicine clinic? What challenges or gaps have you identified in medication management where pharmacists can be helpful?

Dr. Kokosa has encountered several challenges since

starting in the gender medicine clinic. “The first was teasing out the exact role of the pharmacist in this interdisciplinary clinic. Our initial visits are typically conducted by a physician. Do I fit into those initial visits versus follow-up visits? There is not a lot of literature on a role of a pharmacist in a gender medicine clinic or their role in managing hormone therapy. That makes it challenging to determine the best use of a pharmacist.”

Dr. Kokosa also found that “this population of patients is particularly engaged in their care and they often do a lot of on-line research. So naturally they have a lot of questions. They are also seen every three months during the first year on hormone therapy so it is really challenging for our primary physician to manage all of the mychart messages as well as the visits. I have been able to fill in that gap to help reduce wait times because I can see patients for follow-up visits for monitoring and dose adjustments. I can also field a lot of mychart messages to help free up the provider to be able to focus on getting patients the care that they need.” In regard to medication access, Dr. Kokosa has identified that this patient population is often uninsured, underinsured, or have unstable income. Therefore, it can be a challenge to afford medications. She finds that “a pharmacist can be really wellequipped to discuss the different preparations in terms of cost and financial resources that might be available”.

Another challenge can be having financial support for a pharmacist. Dr. Kokosa is appreciative that Duke’s Department of Pharmacy and Division of Endocrinology see the gender medicine clinic as incredibly important work and they have been fully supportive of a pharmacist’s involvement. Advice that Dr. Kokosa has for a pharmacist who is interested in implementing a similar role in a gender medicine clinic is, “start by building your support network”. For Dr. Kokosa it meant joining WPATH, which provides training programs, support for providers and forums for questions.

What are your future goals in the gender medicine clinic?

Starting in 2022, Dr. Kokosa’s presence in the gender medicine clinic will increase to by an additional ½ day per week. She is hoping to solidify the best and most efficient role for a pharmacist. She also plans to add to the literature so that she can help pharmacists become more involved in gender medicine clinic. Her goal is to continue to determine where a pharmacist is best utilized and establish an approach for implementation of a clinical pharmacist in an interdisciplinary gender medicine clinic.

Page 41

The “Domain Reform for Unlawful Drug Sellers” or “DRUGS” Act would require domain name

REALTY

ELITE

sellers W h ato t wlock e d o ?and suspend websites when enforcement show evidence VUCA regulators Health has createdor thelaw largest library of medication education videos that can that they are selling drugs illegally. It’s integrate into websites, mobile apps, smart speakers, and pharmacy management endorsed by the APhA, NCPA, and NABP. systems.

We work directly with health systems, pharmacies, and developers to equip them with a new way to deliver patient education and improve outcomes.

In all 50 states, pharmacies can now offer a paperless alternative to the traditional leaflets given with every prescription.

VaccineSheets.com - Vaccine Info Statements all in one place.

Learn more about how this important

VaccineSheets.com was created by VUCA Health to pharmacies andwill piece ofhelp legislation other healthcare providers provide digital your patients at: access to vaccine information statements (VIS).

help protect

https://safedr.ug/DRUGS-Act

We have created three ways you can provide your patients with a digital VIS: Provide Link Show QR Code Print VIS QR Code

PSM

WWW.VUCAHEALTH.COM

@VUCAHEALTH Page 42

New Resources to Help Pharmacists Manage Osteoarthritis Osteoarthritis (OA), the most common form of arthritis, is a serious disease affecting 1 in 7 US adults. The personal and economic burden of OA is significant, and the effects are felt by adults with OA, their families, employers, and communities. The good news is that there are strategies to help prevent and manage OA, a painful and costly disease.

The Osteoarthritis Action Alliance (OAAA) collaborated with Pfizer to update and expand OACareTools, an online toolkit that aims to reduce the burden of OA. OACareTools contains 21 NEW tools and resources for healthcare providers in primary care – physicians, nurse practitioners, physician assistances, pharmacists, physical/occupational therapists, sports medicine professionals, athletic trainers, fitness professionals – and their patients.

In addition to 9 self-paced educational modules on OA, OACareTools includes customized multi-modal tools and resources for providers and patients, such as:

with recommendations and guidance to help patients develop their own physical activity plans.

Visit www.oacaretools.org for a complete listing and description of resources. In addition, visit the OACareTools Adult & Employee page for resources that pharmacists can make available to their patients.

• Guidelines for managing OA – Learn about the latest clinical guidelines, at a glance.

•Functional assessments – Learn about a variety of functional assessments used in OA care and get tips for implementing these assessments into routine care.

•Exercise Rx for Arthritis – Help your patients find the type, frequency, and intensity of physical activity that best meets their personal needs and situation.

•Evidence-based programs – Physical activity and self-management education programs for patients with OA that may be available in your community.

• Getting started with physical activity – A worksheet

Page 43

The Osteoarthritis Action Alliance (OAAA)

The OAAA is a national coalition of concerned organizations mobilized by the Arthritis Foundation and the Centers for Disease Control and Prevention.

This coalition is committed to elevating OA as a national health priority and promoting effective policy solutions that aim to address the individual and national toll of OA. In addition, the OAAA, with the public health community, is working to ensure people with OA have the access, skills, and capacity to benefit from effective and proven interventions.

Since many of the recommended drug therapies for OA are available with a prescription, pharmacists are well-positioned to recommend and counsel patients on proper treatment options .

A free CE program is available for pharmacists through the OAAA available at: https://oaaction. unc.edu/resource-library/for-health-professionals/pharmacists/ Ref: https://oaaction.unc.edu

Congratulations 2022

SCHOLARSHIP

WINNERS

Pharmacists Mutual is proud to support pharmacy students interested in serving in an independent or small chain community pharmacy or an underserved geographic or cultural community.

EACH STUDENT LISTED RECEIVED A $3,000 SCHOLARSHIP. Marlee Clements Mercer University Allison Welsh North Dakota State University Amber Conklin Ohio Northern University Bailey Bartley Sullivan University Celia Mix North Dakota State University Casey O’Quinn Medical University of South Carolina Dylan Johnston Husson University

ACCEPTING APPLICATIONS FOR 2023 SCHOLARSHIP

October 1, 2022 - December 1, 2022 phmic.com/scholarship

Elizabeth Braun University of Wisconsin–Madison Laura Harris Auburn University Kaia’ Harrison Duquesne University Katelyn Carswell Auburn University Kaylen Luginbill Schier Southwestern Oklahoma State University Peyton Gilbert University of Texas at Tyler Natalie Morton Novak Mercer University Lauren Williams University of Kentucky Megan Navarro University of the Incarnate Word Trey Carter University of Kentucky Taylor Williams University of Kentucky

Pharmacists Mutual Insurance Company Algona, Iowa phmic.com

Savannah Rose Sullivan University Victoria Vo Virginia Commonwealth University Page 44

VOTE FOR Sean M. Jeffery www.pharmacist.com

For APhA President The world has changed a lot in the past two years, and so has APhA. As a Trustee, I served during a pivotal time in our professions history. I hope to continue this services as President-Elect. My experience as Director of Pharmacy for Connecticut’s largest integrated provider group, past president and interim CEO of the American Society of Consultant Pharmacists, and recent service as a Trustee provide a unique perspective on the needs of our profession. I am asking for your vote so I can continue to guide APhA through these changes. Thank you for your support, and please be sure to vote in the election. Click here to view a special message for North Carolina Pharmacists.

Page 45

YOUR COMMUNITY HEALTH PLAN Big Health Plan Options for Small Groups are Now Available Groups with 5+ employees, self-funding is possible with Your Community Health Plan.

Big or small, Your Community Health Plan believes that all employers should have health plan options that work for both their employees and their bottom line. Access to an ERISA qualified Level Funded Health Plan is now accessible for groups between 5-100 lives.

Plan options include:

No Cost Primary Care Your employees have access

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Contact Us! 919.964.1450 | YourCommunityHealthPlan.com Page 46