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MICHIGAN T H E O F F I C I A L J O U R N A L O F T H E M I C H I G A N P H A R M A C I S T S A S S O C I AT I O N

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MICHIGAN PHARMACY

ECONOMIC SURVEY

LEGISLATIVE NEWS

Bills allowing pharmacists to fill emergency insulin pass into law, PBM reform waits for a vote, and many more bills are on the move. (p. 12)

PHARMACY COMPLIANCE

Is your compliance program up to par? Ensure you are legally protected and in-the-know. (p. 24)

INNOVATIVE MODEL

2021 July/Aug./Sept. | Vol. 59, Issue 3

Pharmacy team develops awardwinning program to improve patient safety at height of pandemic. (p. 27)

MichiganPharmacists.org

IN THIS ISSUE LEGISLATIVE UPDATE

12 3 President’s Platform

At a time of rapid change for MPA and society, pharmacy professionals are well-suited to meet the moment.

16 COVID VACCINE 101

In an evolving pandemic environment, stay apprised of vaccine basics like common errors, symptoms and reporting requirements.

MSHP FOCUS

HALF-YEAR REPORT

5 C EO Corner

9 S tudent Focus

18 Economic Survey

24 Legal Insights

MPA is building for its future with a staff reorganization and initiatives to position us to better serve our members.

Take the pulse of the profession of pharmacy with exclusive economic trends and data from Michigan.

The cost of insulin skyrockets, even while technology advances. But what good is new technology if it’s out of reach?

Get up-to-speed on the legal requirements and ramifications of pharmacy compliance programs.

EDITOR: Mark Glasper; MANAGING EDITOR: Mary Beth Wardell Michigan Pharmacist (ISSN 1081-6089) is the official journal of the Michigan Pharmacists Association, published four times a year at 408 Kalamazoo Plaza, Lansing, MI 48933. Publication Number: USPS-345-600. Phone: (517) 484-1466, Fax: (517) 484-4893 Website: www.MichiganPharmacists.org, E-mail: MPA@MichiganPharmacists.org, Advertising Information: Visit www.MichiganPharmacists.org/news/advertising or contact Mary Beth Wardell, MPA communications manager, at (517) 377-0232 or MaryBeth@MichiganPharmacists.org

MichiganPharmacists.org

All opinions expressed in Michigan Pharmacist are not necessarily official positions or policies of the Association. Publication of an advertisement does not represent an endorsement. Michigan Pharmacist is subject to the standards established by the Association. Michigan Pharmacist is distributed as a regular membership service, paid for through allocation of membership dues. Nonpharmacist subscriptions are $40 annually. Postmaster send address changes to: 408 Kalamazoo Plaza, Lansing, MI 48933. Periodical postage paid at Lansing, Mich. Nothing in this publication may be reproduced in any manner, either in whole or in part, without specific written permission of the publisher. © Michigan Pharmacists Association, 2021

— PRESIDENT’S PLATFORM —

MEETING CHANGE with HOPE Pharmacy Professionals Uniquely Suited to Moment

s we roll into midsummer, I am hit by a stronger sense of excitement for the activities that enchant Michiganders than in years past. Not only are we able to enjoy the beauty of our great state, but we are able to do so with our family and friends this year. We still have a long way to go to meet herd immunity and safety for all, but we are closer.

BY HEATHER CHRISTENSEN,

Pharm.D., clinical pharmacy specialist, ambulatory care, Spectrum Health West Michigan; president, Michigan Pharmacists Association

There has been so much change in the past year – many things that bring sorrow to my heart – and yet, through it all, there is hope. Hope that with your support and engagement fostering change and acceptance, equity will begin to be realized. The events of the past year have affected each of us differently based on our individual experiences. This results in differing understanding, reflective of the uniqueness that makes us human. Our roles as pharmacy professionals provide a unique setting to help foster continued growth and healing, not only for those close to us, but for the community at large. Change is often noted to be hard, and, as I write this article, I reflect on the changes our organization has seen this year, specifically the significant change of staff. Considering the long-standing commitment of Mary Farrington as education director and Dianne Malburg in her many roles, including chief operations officer, MPA has been incredibly fortunate for many years. Their departure, following the retirement of Larry Wagenknecht as chief executive officer, constitutes a genuine loss of experience and institutional knowledge, while also presenting an opportunity for fresh perspectives. These team

advocacy. This has and will continue to be a focus for MPA, with the strong team comprising the Local Association Development Committee providing a great place for each of us to engage and start discussions of change. Change is often synonymous with fear. I feel it has been fear that has driven decisions made by some across the state and nation in the last year, resulting in continued disparities for many. As William Zellmer said in a recent article in the American Journal of Health-System Pharmacy, “Collectively, pharmacists have a deep reservoir of traits that should be tapped in these troubling times. These traits include knowledge and respect for science, deep professional commitment to improving human health, skill in critical thinking, and expertise in interpersonal communications. The power of these attributes is magnified by the high marks pharmacists receive from the public for honesty and ethical standards.”1 I could not have said it better and feel, with these traits, we are each well-equipped to work within our circles of influence through local activism. Through activism, we create safe environments for communication with open

“Collectively, pharmacists have a deep reservoir of traits that should be tapped in these troubling times. These traits include knowledge and respect for science, deep professional commitment to improving human health, skill in critical thinking, and expertise in interpersonal communications. The power of these attributes is magnified by the high marks pharmacists receive from the public for honesty and ethical standards.” — WILLIAM ZELLMER members dedicated more than 25 years each, shaping the profession of pharmacy across Michigan, and that is nothing short of amazing. I feel so lucky to have known and worked with each of them. Under the leadership of our new chief executive officer, Mark Glasper, and with unanimous support from the MPA Board of Directors, organizational adjustments have been made to support MPA operations with the goal of optimizing services for those on the front line, pharmacy professionals. Focus on engagement is essential to a membership organization, and it is vital our members continue to be involved and active in the organization. Only through participation can your voice be heard, and that is what will drive the future of the organization. With a highly engaged board leading the way, continuity will not be lost. Rather, the organization will remain strong, as it has for so many years. One way we can remain strong is with local

minds that seek to understand differences while honestly searching for equitable solutions. Now is not the time to stand back and see what happens; rather, it is the time to engage through active participation and communication. I personally do not consider change something that needs to be feared: although difficult, it is necessary for growth. As our Board goes into our strategic planning this July, I am excited for our discussion and our great potential for growth. Please share your thoughts and concerns with me, allowing me to be ready to share them with the team as we work to create a path forward for the Michigan Pharmacists Association, supported and strengthened by our membership across every locality and region. REFERENCES: 1. W illiam A Zellmer, BSPharm, MPH American Journal of Health-System Pharmacy, Volume 78, Issue 6, 15 March 2021, Pages 525 -526, https://doi.org/10.1093/ajhp/zxaa435

2021 July/Aug./Sept. | Vol. 59, Issue 3

— CEO CORNER —

BUILDING for OUR FUTURE

he Michigan Pharmacists Association (MPA) experienced a recent staff reorganization to align departments along generally accepted association management principles and to position the organization for future growth. These changes coincide with the development of our next MPA Strategic Plan over the coming months and will place staff resources where they are needed for us to be successful. Business decisions that affect staff are never easy but are sometimes necessary for the organization to thrive and to serve you, our members, in new and exciting ways.

BY MARK GLASPER, chief executive officer, Michigan Pharmacists Association

In this column, you can see the new MPA staff organizational chart. We have distinct departments built around typical association management product and service areas. Heading each department is a director responsible for that department’s performance. These directors will comprise a management team along with myself that will help guide the day-to-day operations of headquarters staff in support of our strategic plan on behalf of the MPA membership.

Membership Growth Top Priority Addressing membership recruitment and retention was a major theme as I progressed through the interview process last fall to become your CEO. From the search consultant that was used to the MPA Executive Board Search Committee and then to the Executive Board itself, they all spoke of the need to reverse declining membership. In fact, my entire final interview with the Executive Board was focused solely on how to build membership. Declining membership is not unique to MPA, nor is it anyone’s fault. It’s a systemic problem throughout the association community where executives are digging deep to uncover the reasons for falling membership. I would like to tell you it’s an easy fix but, in reality, it’s going to take time and a lot of effort. The first step has been to hire a director of membership. That was the first staff change I knew was needed, someone who has an association management background and who will look at membership strategically. There are two major issues to address: how do we attract new members and how do we keep them. Looking at one issue or the other won’t get the job done. They are intertwined with our value proposition and must address the needs and wants of our members and prospective members. Without a growing and engaged membership, there is no MPA.

Marketing MPA to Drive Revenue The second area to be addressed was marketing, and that’s why we’re hiring a director of marketing & communications. This seasoned professional will work with the other department directors to develop marketing

MichiganPharmacists.org

plans to build existing programs while looking for new opportunities to enhance organizational revenues. Case in point is how we serve sponsors, exhibitors and advertisers. Currently, there is no single source on staff to respond to inquiries from these business interests. Companies may get their initial marketing request handled but there is no up-sale to capture additional business. Prospective sponsors, exhibitors and advertisers deserve to see and understand all the marketing opportunities available to them through MPA, so they can make more educated decisions on how to reach their target markets. Please understand that membership and serving you is still our focus. However, developing additional products and services that better serve you will ultimately help us grow membership and make for a stronger MPA.

Building Staff Infrastructure A third area for staff change is the creation of an MPA Finance & Administration Department to help staff members serve you better. The accounting, human resources and information technology areas of the business will be housed in this department. We have recently hired a department director who will oversee these critical areas. For any business and especially with associations, this department is the backbone of the organization. While it is not responsible for raising revenues, it does certainly help keep an eye on expenses, which enhances the entire organization’s bottom line. The department also will provide all staff members with the support they need to do their jobs more effectively and efficiently.

Pharmacy Knowledge Resources Abound MPA staff are well equipped to handle pharmacy questions and issues as they arise. We have an exceptionally talented pharmacist heading our professional development and emergency preparedness programs in Farah Jalloul, Pharm.D. She is instrumental in keeping staff informed of pharmacy issues so we can keep you apprised. New Executive Fellow Auggie Bui will assist Farah with ongoing pharmacy programs. We’re also very proud to have former pharmacy technician

— CEO CORNER —

“On behalf of all staff, current as well as those being hired, we are ready to serve you. We are ready to grow MPA and take it to the next level in support of you, our members.” Michigan Pharmacists Association Staff Organizational Chart

Brian Sapita heading our government affairs efforts. The combination of his pharmacy knowledge and seven years in the Michigan Legislature allows him to monitor all issues affecting pharmacy as they arise. Even relative staff newcomer Executive Office Administrator AlexAndria Halcomb spent the first seven years of her career as a pharmacy technician. We (and I) are most fortunate to have her pharmacy knowledge at MPA. And, while not a pharmacist, I came to MPA last December after serving almost four years in the same capacity with the Kentucky Pharmacists Association. I did there exactly

what I’ve done throughout my association career and that is to know exactly where to go for input on issues affecting the profession. That’s why we’re continuing to build strong committee resources, so we get critical input from you, the members. For example, we initiated a Government Affairs Committee this year that attracted interest from 25-plus members who are willing and anxious to assist us in discussions regarding our legislative priorities. The diverse group, led by Chair Eric Roath and Vice Chair Dan Lobb, is comprised of members from every practice section. Also new, the Communications Work Group led by John Brubaker will supply staff

with added support on social media. We also have tremendous resources available from our national partners, including American Pharmacists Association, National Community Pharmacists Association, National Association of Chain Drug Stores, American Society of Health-System Pharmacists, National Association of State Pharmacy Associations, Pharmacy Technician Certification Board and others. On behalf of all staff, current as well as those being hired, we are ready to serve you. We are ready to grow MPA and take it to the next level in support of you, our members. 2021 July/Aug./Sept. | Vol. 59, Issue 3

— EVENTS CALENDAR —

EVENTS CALENDAR MPA, local association and national pharmacy organization events as well as health observances are included below. For the most up-to-date information, please visit our online calendar at www.MichiganPharmacists.org/eventscalendar.

JULY 2021

21 22 28

Wednesday, July 21 PSI Board of Directors Meeting Virtual Only

Thursday, July 22

Immunization Training Virtual Only

Wednesday, July 28 World Hepatitis Day Nationwide

AUGUST 2021

1-31 24 26

Sunday, August 1 – Tuesday, August 31

National Immunization Awareness Month Nationwide

Tuesday, Aug. 24

SEPTEMBER SEPTEMBER 2021 2021 SEPTEMBER 2021

1-31 1 6 9 18

Wednesday, Sept. 1 – Thursday, Sept. 30

Healthy Aging Month Nationwide

Wednesday, Sept. 1

MPA New Practitioner Committee Meeting Virtual Only

Monday, Sept. 6 Labor Day MPA Office Closed

Thursday, Sept. 9

MPA Third Party Committee Meeting Virtual Only

Saturday, Sept. 18

MSPT Five-Live Continuing Education Program Virtual Only

24 27 27 28 30

Friday, Sept. 24

PSI Board of Directors Retreat Meeting Virtual Only

Monday, Sept. 27

Immunization Training Virtual Only

Monday, Sept. 27

MPA Executive Board Meeting MPA Headquarters

Tuesday, Sept. 28

MPA Pharmacy Day at the Capitol Michigan State Capitol Lawn

Thursday, Sept. 30

MPA Community Pharmacy Council Meeting Virtual Only

Immunization Training Virtual Only

Thursday, Aug. 26

MSHP Antimicrobial Stewardship Symposium Virtual Only

Please note: Some virtual board and committee meetings may be subject to a change to in-person at MPA headquarters, at the discretion of the members. Please check the online calendar or contact MPA@MichiganPharmacists.org for more information.

SUBMIT AN AWARD NOMINATION! Do You or a Colleague Deserve Recognition? Nominate yourself or one of your colleagues for a prestigious award to recognize their professional accomplishments! Choose from a large variety of awards, including eight Michigan Pharmacists Association (MPA) awards, four Michigan Society of Health-System Pharmacists (MSHP) awards, two Michigan Society of Pharmacy Technicians (MSPT) awards, three Michigan Pharmacy PAC awards, three local association awards, the Michigan Society of Community Pharmacists (MSCP) Pharmacist of the Year Award or the Consultant and Specialty Pharmacists of Michigan (CSPM) Pharmacist of the Year Award. MSHP nominations are due Sept. 1. All other award nominations are due Oct. 1. Learn more and submit your award nominations online at www.MichiganPharmacists.org/awards.

MichiganPharmacists.org

— CONTINUING EDUCATION —

CE Event Recaps and Opportunities Law & Policy Symposium Recap

‘ Live Your Best Life’ Event Recap

The Michigan Pharmacists Association (MPA) held its annual Pharmacy Law and Policy Symposium on April 28. Topics at this day-long virtual event included:

The Michigan Society of Community Pharmacists (MSCP) and Michigan Society of Pharmacy Technicians (MSPT) held a joint daylong virtual event on May 15. Topics focused on helping pharmacy professionals live their best life. Topics included:

• “Drug Supply Chain Security Act and Counterfeit Drugs,” presented by Ilisa Bernstein, Pharm.D., JD, senior vice president of pharmacy practice and government affairs at American Pharmacists Association in North Bethesda, Md., and Shabbir Imber Safdar, executive director for the Partnership for Safe Medicines in San Francisco, Calif.

• “FDA and Health-System Pharmacy Compounding,” presented by Rosilend Lawson, branch chief in the Division of Compounding Policy and Outreach, Office of Compounding Quality and Compliance at the U.S. Food and Drug Administration (FDA) in Silver Spring, Md., and Tom Kraus, vice president of government relations at American Society of Health-System Pharmacists in Washington, D.C.

• “Pharmacy Law and Ethics Update,” presented by Kim Sveska, R.Ph., JD, principle and lawyer at Foley, Baron, Metzger & Juip, PLLC in Milford, Mich.

• “DEA Overview: Methods of Diversion and Drug Trends,” presented by Kathy Federico, diversion program manager at the Drug Enforcement Administration (DEA) in Detroit, Mich.

• “Pharmacy Law and Regulatory Update,” presented by Farah Jalloul, Pharm.D., director of professional development at MPA in Lansing, Mich., and Brian Sapita, director of government affairs at MPA in Lansing, Mich. Participants could earn up to six hours of live continuing education credit, covering the law education requirement for pharmacy technicians and the ethics and jurisprudence training requirement for pharmacists. If you missed out on this event and would like to view the recordings, please visit MPA’s website at https://www.michiganpharmacists. org/2021PharmLaw.

Growth at Any Stage of Your Pharmacy Career On May 13, MPA held a leadership development webinar featuring established member leaders at different stages of their pharmacy career, discussing leadership and management and how it has impacted their professional and personal trajectory. The webinar included panelists Stephanie LaPointe, Pharm.D., CSPO, FMPA, director of specialty patient services – growth + innovation at Optum and residency program director for Diplomat in Flint, Mich., Robin Curtis, Pharm.D., clinical care coordinator at SpartanNash in Grand Rapids, Mich., and Christopher Maksym, Pharm.D., retired from the University of Michigan College of Pharmacy in Dexter, Mich. Panelists described their roles, responsibilities and characteristics of pharmacy leaders who are actively engaged in the advancement of the profession, discussed the essential skills a pharmacy professional should acquire to be a successful leader and addressed leadership development opportunities to enhance a pharmacy professional’s career advancement.

• “Behavioral Health – Breaking Down Barriers: Helping Patients Live Their Best Lives,” presented by Taylor Pettit-Rademacker, LMSW, CAADC, workforce development trainer at Cherry Health in Grand Rapids, Mich., and Lori Heetderks, CPhT, 340B program coordinator and pharmacy technician at Cherry Health in Grand Rapids, Mich.

• “Foundations of Health: Optimize Health Using Supplements and Diet,” presented by Brandi Grimmer, CPhT, nutritional consultant at Keystone Pharmacy in Wyoming, Mich.

• “Understanding the Human/Animal Bond,” presented by Dr. Jill Sackman, DVM, Ph.D., owner and CEO at Animal Behavior Consultants of Michigan, PLC in Oxford, Mich., and Ginny Mikita, JD, attorney at Mikita Kruse Law Center and animal chaplain at Animal Blessings in Rockford, Mich.

• “A Healthy ‘Great Place to Work’ Culture Begins with Trust,” presented by Pinky McPherson, MEd, owner and lead facilitator of PMc Consulting LLC in Grand Rapids, Mich. Six hours of home study continuing education credits can be obtained by purchasing the recordings of this course at https:// www.michiganpharmacists.org/2021mscpmspt.

Immunization Training Programs In response to the pandemic and increasing need for pharmacists to become immunizers, MPA has trained 161 pharmacists through a series of American Pharmacists Association (APhA) Pharmacybased Immunization Delivery Certificate Training Programs since January. The purpose of this certificate training program is to prepare pharmacists with comprehensive knowledge, skills and resources necessary to provide immunization services to patients across the life span. Watch the events calendar on MPA’s website at https://www.michiganpharmacists.org/ for additional training programs to be scheduled. Additionally, in recognition of the critical role that pharmacy technicians can play to increase the accessibility of vaccine administration services, MPA now has a pharmacy technician immunization administration program available. This four-part program, consisting of required readings, video-recorded lectures, a virtual live seminar and demonstration, has been specifically designed to provide pharmacy technicians with the skills training to administer immunizations. This course fulfills the education requirement for the Pharmacy Technician Certification Board (PTCB) Immunization Administration Certificate Program. Additional information about MPA’s Pharmacy Technician Immunization Administration Course can be found online at https://www. michiganpharmacists.org/education/pharm_tech_immun. 2021 July/Aug./Sept. | Vol. 59, Issue 3

— BIOS AND MEMORIES —

NEW STAFF BIOS AUGUSTINE BUI, MPA/PSI EXECUTIVE FELLOW Augustine Bui joins the Michigan Pharmacists Association (MPA) as the MPA/Pharmacy Services, Inc. (PSI) executive fellow. He graduated from the University of California, Riverside with a Bachelor of Science in bioengineering and most recently finished his Doctor of Pharmacy/ Master of Business Administration dual degree from East Tennessee State University. He has previously been involved with the Tennessee Pharmacists Association and American Pharmacists Association (APhA), working to increase student pharmacists’ advocacy efforts and creating engaging social media communications. He looks forward to working with the staff at MPA to further his education and training, as well as to serve MPA’s members and advance the profession of pharmacy. He can be reached at (517) 377-0242 or Augustine@MichiganPharmacists.org.

ALEXANDRIA HALCOMB, EXECUTIVE OFFICE ADMINISTRATOR AlexAndria Halcomb is the Michigan Pharmacists Association’s new executive office administrator, beginning her journey with the organization in April. Alex has a background as a certified pharmacy technician (CPhT), having worked in a pharmacy for 10 years, and as an executive assistant with more than 16 years’ experience in administrative work. Alex assists in MPA’s day-to-day operations. She is dedicated to the organization’s mission and enjoys impact-focused work. In addition, Alex is passionate about ending human trafficking and has volunteered with various U.S. nonprofits since 2016. In her spare time, she also enjoys cooking, traveling, hiking and spending time with family. She can be reached at (517) 377-0252 or by emailing Alex@ MichiganPharmacists.org.

MichiganPharmacists.org

BRYAN FREEMAN, DIRECTOR OF MARKETING AND COMMUNICATIONS Bryan Freeman joins MPA as director of marketing and communications, bringing more than 20 years of marketing experience to the position. Prior to joining MPA, he led the marketing departments for a variety of companies in the health care, education and financial services industries. Under his marketing leadership, these companies enhanced their brand image, modernized their marketing organizations, remodeled marketing strategies and drove expansive growth in customer acquisition. A lifelong Michigan resident, he graduated from the University of Michigan with a degree in psychology as a natural science.

JENNIFER MORA, DIRECTOR OF FINANCE AND ADMINISTRATION Jennifer Mora has been selected as MPA’s new director of finance and administration, after working for more than 10 years in the finance and human resources fields. She recently worked at Michigan State University GRAIN Research and Innovation as an accountant. She is a hands-on and participative manager that will lead and develop the internal team to support the following areas: finance, business planning and budgeting, human resources, administration and IT. She is excited to find a new home among the professionals at MPA and looks forward to serving MPA members and helping to advance the profession of pharmacy.

DAVE VOSS, INFORMATION TECHNOLOGY (IT) MANAGER Dave Voss joins MPA as the Information Technology (IT) manager, with more than 25 years of experience as an IT professional. He graduated from Michigan Technological University with a degree in Applied Mathematics and has worked in senior IT leadership and technical positions throughout his career. Dave brings extensive IT infrastructure and enterprise application support experience to his role as IT manager, and most recently has been supporting migrations to cloud-based services from traditional on-premise technologies. Dave is excited about his new role with the MPA and looks forward to helping the MPA Team and its members with their current IT needs and developing the MPA IT roadmap together.

SCOTT WALSH, DIRECTOR OF MEMBERSHIP Scott Walsh joins MPA as the director of membership, bringing more than 10 years of experience as an association professional. He graduated from Michigan State University with a degree in communications, and most recently was an assistant director for the Michigan Manufactured Housing, RV and Campground Association (MMHRVCA). He brings experience in membership development, retention, marketing and sales. He is very excited to get up to speed and hit the ground running in his new role and looks forward to serving the members of MPA.

BRIAN SAPITA has been promoted to the director of government affairs for MPA, after serving as the government affairs manager for the past two years. Previously, Brian spent 10 years in the Michigan Legislature as a legislative aide and about two years as a pharmacy technician at Meijer. ALISHA SWANCHARA joined MPA in December 2020 as the education assistant and is being promoted to the director of meetings & education following the departure of Director of Education Mary Farrington. Prior to MPA, Alisha was a meeting and event manager for a third party planning company and has a bachelor’s degree in hospitality tourism management from Grand Valley State University.

— STUDENT FOCUS —

RISING COST OF INSULIN IMPACTS PATIENT OUTCOMES D BY ZAID SIMON YOUSIF, Doctor of

Pharmacy candidate at the University of Michigan, class of 2023

iabetes is a nationwide epidemic in the United States. According to the American Diabetes Association (ADA), 34 million individuals are diagnosed with diabetes and 88 million are diagnosed with pre-diabetes in the U.S. today.1 The annual cost burden of diabetes is estimated to be $327 billion dollars, and that price is growing larger every year. In our home state alone, 865,000 Michiganders are diagnosed with diabetes, 11.5 percent of the adult population.1 Diabetes is a costly diagnosis; the ADA reports people with diabetes spend 2.3 times more on their healthcare than those without diabetes.1 The rising cost is a concerning issue, with thousands of Americans rationing their insulin to make ends meet. As a result, patient outcomes are not improving, and rising costs are putting patients more at risk for Diabetic Ketoacidosis (DKA), neuropathy, nephropathy and numerous cardiovascular diseases.

Figure 1: the U.S. wholesale accusation cost (WAC) of insulin increased by 15-17% for the four insulin classes from 2012-2016.2 The price of insulin has risen significantly since its discovery. In an analysis published by the ADA, Cefalu et al. (2018) reports the U.S. wholesale acquisition cost (WAC) of insulin increased by 15-17 percent from 2012-2016 for the four insulin classes.2 This means that an elderly

diabetic on Medicare is more likely to reach their coverage gap due to the rising costs. Consequently, Medicare Part D out-of-pocket costs increased by 10 percent each year between 2006 and 2013 – an alarming rate that jeopardizes patient outcomes.2 It is often a misconception that diabetics are only affected physically when they cannot access or afford insulin. In a qualitative study conducted by Willner, Whittemore and Keene (2020) that examines the experiences diabetics face when they cannot access their insulin due to financial barriers, participants described their feelings as “walking on a tight rope” as well as symptoms aligned with post-traumatic stress disorder.3 The psychological stress can be as detrimental as the physical effects of uncontrolled diabetes. Comparing the average cost of one unit of insulin in the U.S. to that of other countries can be alarming, but it is the first step in acknowledging the seriousness of the issue. According to Mulcahy, Schwam and Edenfield (2020), the average cost for one unit of insulin in the U.S. in 2018 was about $99; meanwhile in Canada, it was $12, Australia about $7, and the U.K $7.50.4 These startling differences are one of the many reasons diabetes in America is the raging epidemic that it is. Ultimately, diabetes can be one of the toughest diseases to manage, regardless of the cost burden. Scientists continue to research and discover breakthrough therapies that aid in the management of diabetes, such as insulin pumps and continuous glucose monitoring technology. With the implementation of these advancements, diabetes can be managed safely and effectively, but the largest obstacle remains financial. What purpose do advanced technology and improved insulin formulations serve if most Americans cannot afford them? To improve patient outcomes, we must collectively recognize diabetes should never cause an individual to choose their pocketbook over their health. References available upon request from the MPA office. 2021 July/Aug./Sept. | Vol. 59, Issue 3

— FROM THE FOUNDATION —

TO OUR DONORS, THANK YOU A

s the charity arm of the Michigan Pharmacists Association (MPA), the Michigan Pharmacy Foundation (MPF) is an endeavor by pharmacy professionals across Michigan to invest in the future of the profession for the improvement and promotion of public health and public education. We have accomplished this through the years with the consistent, inspirational generosity of our donors. However, the contributions of time and resources this last year feel more significant than ever before.

BY SPENCER HIGGINS, membership development manager, Michigan Pharmacists Association

The entire country has endured the harrowing effects of the COVID-19 pandemic. Six-hundred thousand Americans have died and more than 20,000 Michiganders. The economy has suffered in a way that has undermined millions of Americans’ ability to meet their basic needs. In the face of all this, pharmacy professionals have served tirelessly to bring the pandemic to an end and protect our communities, working long hours in often dangerous conditions. Amidst the sacrifice and struggle, the continued commitment of pharmacy professionals to invest their time and resources in the MPF is incredibly humbling. Consequently, it is with humility and purpose that MPF has carried on with its mission throughout this time and will continue to do so. Whether through scholarships to exemplary student pharmacists, grants to support innovative research projects or other means of advancing the pharmacy profession, MPF has made significant progress moving towards its vision. Individuals in many different stages of their careers and groups across the state have benefited from the goodwill of MPF donors through many different projects and programs. For that opportunity and for your courage and commitment throughout this difficult period, we at MPA thank you all, from the bottom of our hearts. It’s truly an honor to serve you.

2021 MPF Golf Classic: The Michigan Pharmacy Foundation’s 2021 Golf Classic drew 70 golfers to Eldorado Golf Course in Mason on June 23 for a successful fundraising drive The event raised a total of $23,000 for the Foundation, a generous show of support after a year of compromised fundraising efforts. Thank you to all of our participants, sponsors and volunteers!

MPA Past President Ed Szandzik, MPA President Heather Christensen, MPA Executive Board member Hope Broxterman and Jayson Zebari made up the winning first place team at the MPF Annual Golf outing June 23.

Second place team members Todd Raehtz, Kevin Johnson, Steven Craig and MPF Board member Chris Maksym pause for a photo on the green June 23.

MPF Chair Susan Devuyst-Miller presents prizes to the following winners of the MPF Annual Golf Classic: Women’s Closest to the Pin:

Hope Broxterman (1)

Men’s Closest to the Pin:

David Allen (2)

Men’s Longest Drive:

Matt Hoch (3)

Women’s Longest Drive:

Shelly Wolverton

MichiganPharmacists.org

Chad Day makes the winning putt the morning of June 23 at the MPF Golf Classic Putting Contest.

— LEADERSHIP DEVELOPMENT —

2021 VIRTUAL

MPF HEALTH PROFESSIONAL LEADERSHIP ACADEMY

The Health Professionals Leadership Academy (HPLA) is a program of the Michigan Pharmacy Foundation (MPF) aimed at developing a class of practitioners equipped and motivated to lead their profession in the years ahead. Due to the constraints of the worldwide public health emergency, the ninth annual HPLA program had to be revamped to ensure successful and safe virtual participation.

“supercharge” their effectiveness in these challenging and uncertain times. For six months, these future leaders participated in various activities to better prepare them for the current and future challenges in their organizations and the healthcare profession, including three virtual workshops, three academy webinars and monthly “pod” meetings with other HPLA participants.

The adapted program, was designed for new and seasoned healthcare practitioners from all practice environments who wish to learn, grow and strengthen leadership skills and

One of the most considerable benefits of HPLA is the establishment of a personal leadership project and identification of several personal leadership goals. This provides

future leaders with an opportunity to practice their leadership skills while working on projects and goals they are passionate about. On Friday, June 18, the participants gathered in front of their screens one last time to complete their final virtual workshop and celebrate all the hard work they put into the Academy. Each academy participant presented their leadership project. The day concluded with the participants congratulated for their accomplishments and presented with their certificates of completion from MPF chair Susan DeVuyst-Miller. Congratulations to our graduates!

JAMES AWADA

KEN CHAK

FELICIA CHIBANTE

LISA DIEPHOUSE

HEATHER GIRAND

JACALYN GUALTIERI

JACOB KELAHAN

ZACK MUELLER

MARTIN RODRIGUEZ

BROOKE ROE

NERMEAN TAKLA

ARMEN TOPOUZIAN

2021 July/Aug./Sept. | Vol. 59, Issue 3

— LEGISLATIVE UPDATE —

INSULIN BILLS TAKE EFFECT

PBM Reform Awaits Vote in Senate Committee

BY BRIAN SAPITA, government affairs director, Michigan Pharmacists Association

he Michigan Legislature has finished its work for the first half of the year, and members have returned home for the summer. There are a total of four session days scheduled – which are historically cancelled – between now and Sept. 21 when the Legislature will return to complete the budget and work through the fall. Below is legislation MPA is tracking that is currently moving through the legislative process.

SB 155/Public Act 36: Sen. Kevin Daley

SB 166: Sen. Curt VanderWall (R-Frankfort)

(R- Lapeer) introduced legislation that would allow a pharmacist to dispense an emergency refill of insulin to a patient who had a qualified prescription for insulin in their name but currently doesn’t have a refill left on their prescription. Up to three 30-day supplies could be dispensed in a calendar year. The patient must have received insulin from the pharmacy before, and the pharmacist must use their best judgement in dispensing the insulin to the patient. This bill has been signed by the governor and went into effect on July 1, 2021.

has introduced legislation that would allow Michigan pharmacists to fill non-controlled prescriptions from Canadian or out-of-state midlevel providers, as long as the midlevel provider has the authority to prescribe in their state or province. This bill is in the House Health Policy Committee

SB 247: VanderWall has introduced

SB 156/Public Act 37: Daley also

introduced legislation that would require insurers to cover an emergency refill of insulin dispensed by a pharmacist. This bill was tie-barred to SB 155. It was signed by the governor and took effect July 1, 2021

HB 4348: Rep. Julie Calley (R-Portland) has introduced legislation that would require pharmacy benefit managers (PBMs) to be licensed with the state to operate in Michigan. It would also prohibit PBMs from reimbursing for less than the cost of the medication, end unfair networks and require consumer parity (refill amounts and duration of fills) between

From left, MPA member Chris Munden and CEO Mark Glasper head into the Capitol to meet with legislators April 22.

PBM-owned pharmacies and pharmacies not affiliated with the PBM. It would also change the way audits are conducted in Michigan and prohibit clawbacks and gag clauses in PBM contracts. This bill is in the Senate Health Policy Committee

HB 4351: Rep. Karen Whitsett (D-Detroit) has introduced legislation that would require a PBM to offer a contract to a 340B entity that is the same as a non-340B entity. This bill is in the Senate Health Policy Committee.

legislation that would require insurers to address prior authorizations (PAs) deemed “urgent” within 72 hours and non-urgent PAs within seven business days. Additionally, insurers would be required to post information on prior authorization requirements on the website and provide statistics on approval and denial rates. For denials, the health professional would have to be notified of the reason for the denial and be provided with a remedy for steps moving forward on future requests. This bill is in House Health Policy Committee.

HB 4659: Rep. Joseph Bellino (R-Monroe)

has introduced legislation that would amend the new e-prescribing law and add to the list of exemptions: one, a prescription dispensed by a dispensing prescriber, and two, a prescription that is for a dialysis-related drug administered as part of home-based treatment. This bill is in the Senate Health Policy Comittee.

HB 4352: Allor has introduced legislation that would prohibit a pharmacist from entering a contract with a PBM if the contract includes a gag clause. This bill is in the Senate Health Policy Committee. HB 4089: Rep. Sue Allor (R-Alpena) has MPA President Heather Christensen testifies June 17 in Senate Health Policy Committee in favor of HB 4348, Michigan’s PBM reform bill.

MichiganPharmacists.org

introduced legislation that would classify etizolam as a Schedule 1 controlled substance. This bill is in Senate Judiciary and Public Safety Committee.

MPA CEO Mark Glasper (right), Government Affairs Manager Brian Sapita (not pictured) and MPA member Chris Munden (center) meet with Senate Majority Leader Mike Shirkey (left) on April 22 to discuss PBM Reform.

— ADVOCACY UPDATE —

MPA ROLLS OUT

NEW ADVOCACY SOFTWARE

BY BRIAN SAPITA, government affairs director, Michigan Pharmacists Association

etween improvements to our nearly 60-year-old building, upgrades to our website and staff reorganization, it is safe to say the Michigan Pharmacists Association (MPA) has been making a lot of changes recently. MPA’s Government Affairs Department wanted to get in on the action as well. We are happy to announce new advocacy software, which was created by FiscalNote, the same company that operates VoterVoice. The new advocacy platform will allow our members to contact their legislators with the click of a button. After you have re-registered on the upgraded MPA website, members will have access to the new MPAction center. There, the software will automatically generate a letter/email that is specific to the subject at hand, which you can then personalize to your liking, hit “send,” and the letter will be sent to your state senator, representative or congress-person in the blink of an eye. This new advocacy tool will help us get our message out to all 148 members of the Michigan Legislature. House Bill 4348 – PBM Reform – is our top priority right now, and there are already letters pre-loaded in your advocacy account, all ready to be sent out. This new tool is exclusively available to MPA members and doesn’t require any additional work on your end. If you’re an MPA member, you have access – period. The great part of this new software is that it doesn’t confine our

advocacy message to just our state senators and representatives. We can advocate at the state AND federal level. The software allows us to contact any of our congressional delegation, and, additionally, we can send messages to department secretaries, such as Xavier Becerra, secretary of the U.S. Department of Health and Human Services. This tool will allow our members to advocate on administrative rules moving through federal departments and give you a voice at all levels of government. Another great feature is that when the state goes through its decennial redistricting of legislative districts in 2022, the software will automatically update your profile to know who represents you at each level of government. This new advocacy software will bolster our grassroots efforts and will ensure that MPA continues to be the voice of pharmacy in Michigan, and the only organization that legislators and their staff turn to when they want to know more about the profession of pharmacy. MPA is working on a litany of topics to prepare for the Legislature’s return from their summer break in September. These issues include white bagging in hospital settings, independent authority to administer any vaccine or medication, the authority to prescribe birth control, and of course the ability to invoice and be reimbursed for services rendered under a pharmacist’s scope of practice.

“This new advocacy software will bolster our grassroots efforts and will ensure that MPA continues to be the voice of pharmacy in Michigan.” 2021 July/Aug./Sept. | Vol. 59, Issue 3

— MEMBERSHIP —

CONNECTION, EXPERTISE, GROWTH... YOUR MEMBERSHIP AT WORK

As a distinguished member of the Michigan Pharmacists Association, you are supporting the continued advancement and vibrancy of the profession, along with all the opportunities it offers. Plus, as a member of this historic and evolving organization, you are entitled to premium benefits that you cannot obtain anywhere else. Some of the many benefits of being an MPA member include:

BY SPENCER HIGGINS, membership development manager, Michigan Pharmacists Association

• Exclusive access to pharmacy and law experts who have close connections to regulators and policymakers and can answer your practice and law-related questions quickly and efficiently.

• Networking opportunities: Whether virtual, in-person or a hybrid of the two, MPA is perfecting the art of networking in a post-pandemic world. Many events throughout the year offer fun and easy ways to establish connections that can advance your professional career, expand personal friendships and bring people together to help solve common challenges and advocate for change.

• Live and home study CE opportunities: In addition to many educational programs and events throughout the year, MPA held our first virtual Annual Convention & Exposition this year, attracting more than 500 attendees. We offered 13 hours of live credit and another 15 hours of non-live credit available after the event.

• Advocacy on behalf of your profession: We secured $11 million through the state budget process to be paid to independent pharmacies throughout the 2021 fiscal year. MPA is working hard to bring PBM reform across the finish line in the State Legislature, among many other initiatives that benefit pharmacy.

• Opportunities to directly engage in advocacy: Initiatives such as the Pharmacy Advocacy Response Team (PART) give our members the chance to be at the table where policy and regulatory decisions are being made, keeping pharmacy at the forefront of legislators’ minds.

• Pandemic response: We deployed our MPA Emergency Preparedness Coordinator Farah Jalloul to the State Emergency Operations Center to represent the pharmacy profession in the fight against COVID-19. MPA also advocated for pharmacy during the creation of the emergency executive orders, which allowed pharmacists to vaccinate Michiganders against COVID-19.

• Collaboration with partners on important projects: MPA works with our national partners, including the American Pharmacists Association (APhA), the National Community Pharmacists Association (NCPA), the National Association of Chain Drug Stores (NACDS), the American Society of Health-System Pharmacists (ASHP) and the Pharmacy Technician Certification Board (PTCB), in the fight against direct and indirect remuneration (DIR) fees and for fair reimbursements and provider status.

• Access to informative publications, including our quarterly print journal, the Michigan Pharmacist, four quarterly or monthly practice section publications, as well as the biweekly Pharmacy-Related News (PRN) newsletter.

• Member discounts on networking events and training programs and materials.

• Complementary membership in a local association and practice section association.

• Opportunities to invest in the future of the profession through our charity foundation, the Michigan Pharmacy Foundation.

• Research grant and scholarship opportunities.

• And new to MPA: VoterVoice software, which allows MPA members to connect with their legislators with the click of a button. This will ensure that policy makers at every level understand the importance of their decisions and how they impact pharmacy.

Thanks for being a member of MPA – your continuing support makes our work possible. If you have comments or suggestions about your membership benefits, please reach out and let us know! Email MPA Membership Development Manager Spencer Higgins at Spencer@MichiganPharmacists.org or call (517) 484-1466.

“You are supporting the continued advancement and vibrancy of the profession, along with all the opportunities it offers.” 14

MichiganPharmacists.org

YOUR 2021 MEMBERSHIP INVESTMENT HALF-YEAR REPORT

263

FIRST VIRTUAL ACE

500

ACPE Continuing Education Hours Provided to Members

Over attendees 13-hours Live CE

ACPE CONTINUING EDUCATION CREDITED TO

9,735 PEOPLE

LEGISLATIVE

PANDEMIC UPDATES

600

PHARMACY LAW QUESTIONS ANSWERED 76 Meetings with Legislators 29 Committee Meetings attended 19 Pieces of Legislation Championed

PBM Reform

MPA drafted and championed PBM reform in Michigan and is advancing it through the legislative process.

Reimbursement for Pharmacist-provided Care MPA is exploring legislation that would allow pharmacists to perform and be reimbursed for point-of-care testing and independent vaccine administration.

Administrative Rules

MPA was instrumental in drafting administrative rules this year on pharmacy technicians, pharmacist CE, and Pharmacist General Rules.

White-Bagging

MPA is drafting legislation that addresses white-bagging in health-system pharmacies.

Emergency Refills for Insulin

MPA created legislation that allows pharmacists to dispense an emergency refill of insulin, which was signed into law and took effect July 1.

2021 July/Aug./Sept. | Vol. 59, Issue 3

— PROFESSIONAL AFFAIRS —

COVID-19 VACCINE ADMINISTRATION 101

ealthcare providers’ success in controlling the spread of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections significantly improved with the emergency use authorization (EUA) of the first COVID-19 vaccine in the United States on Dec. 20, 2020.1 Since then, due to the gravity of the public health emergency and the novelty of the vaccines, COVID-19 vaccinators are expected to keep informed of all aspects concerning vaccine administration and potential adverse effects.

Increased Vaccinator Demand By GREGG S. POTTER, Ph.D., B.S. Pharm., R.Ph., MPA Professional Affairs Committee; professor of pharmacology, Ferris State University College of Pharmacy; pharmacist, Rowe Pharmacy Care Clinic

MichiganPharmacists.org

With the increased demand for vaccinations, there has developed an increased demand for vaccinators. In many practice settings across the country, pharmacists and pharmacy technicians have significantly shifted their roles to primarily being involved with the handling, preparation and administration of the COVID-19 vaccines. Additional responsibilities have included being prepared to respond to the vaccine recipients’ questions and concerns before and after vaccination. Due to the rapidly changing nature of the COVID-19 pandemic, different strategies are often required to maintain clinical preventative services. Beyond the initial training that was attained by each vaccine provider, there is an evolving need for updated information and training as healthcare professionals learn more about COVID-19 and the vaccines used to improve the fight against the disease. Vaccine providers within pharmacy can help to improve the vaccination process by contributing to the reporting systems established by the U.S. Department of Health and Human Services (HHS).2 Reporting systems, both required and voluntary, are in place to track the occurrence of adverse effects associated with the use of each of the authorized COVID-19 vaccines.2 Likewise, when errors in administration occur, vaccine providers are able to report the events to the Centers for Disease Control and Prevention (CDC).2 Reporting of adverse effects educates vaccinators, thereby providing more effective counseling tools for patients. Reporting of vaccine administration errors leads to the development of strategies to prevent future occurrences by healthcare providers.2

— PROFESSIONAL AFFAIRS — Common Adverse Effects The COVID-19 vaccines are reactogenic, meaning they will cause some adverse effects in most people that receive them. Because of this, vaccinators should counsel patients about possible local and systemic adverse effects that can occur in the first one to two days following vaccine administration. Table 1 lists the most common adverse effects reported to the CDC, based on clinical trials from the EUAs.3,4,5 The patient should be reassured that these adverse effects are normal signs that the body is building protection against SARS-CoV-2.6 COVID-19 EUA Fact Sheets provide specific information on each of the COVID-19 vaccines.7,8,9 These are to be given to each patient who receives a COVID-19 vaccine. The fact sheets can provide more detail of the potential adverse effects that occur with each approved vaccine. Severe adverse effects such as anaphylaxis have been documented with the COVID-19 vaccines but occur much less frequently.10 For more

Table 1: Most Common Adverse Effects from COVID-19 vaccines Janssen % (Johnson and Johnson)

Moderna %

PfizerBioNTech %

Pain at injection site

48.6

84.1

Fatigue

38.2

62.9

Headache

38.9

64.7

55.1

Muscle pain

33.2

61.5

38.3

Chills/fever

12.8

45.4

31.9

Adverse Effect

detailed instructions on what to do for COVID-19 anaphylaxis prevention and treatment, refer to www.cdc.gov/vaccines/covid-19/clinicalconsiderations/managing-anaphylaxis.html.

Table 2: Common Vaccination Errors (> 10%) received by CDC December 14, 2020 to February 28, 2021 Error Type

Example

% of Topics received

Dose leaked out of syringe, arm

35.2%

Aged < 16 year (Pfizer-BioNTech) or < 18 years (Moderna)

18.5%

Subcutaneous

12.3%

Into shoulder bursa, into gluteal muscle of buttock

10.2%

12.8

45.4

Lower-than authorized dose administered Administered to younger than authorized age Administered by incorrect route Administered at incorrect anatomic site

Due to the rapidly changing nature of the COVID-19 pandemic, different strategies are often required to maintain clinical preventative services. COVID-19 Vaccination Errors Proper administration techniques are necessary to achieve the greatest degree of COVID-19 vaccination effectiveness. Pharmacy vaccinators are required to participate in general vaccination training prior to delivering COVID-19 vaccines. Many organizations, including the Michigan Pharmacists Association (MPA) (www.MichiganPharmacists.org/ immunization) and the American Pharmacists Association (APhA) (www.pharmacist.com/Education/Certificate-Training-Programs/ Immunization) have training courses designed for attendees to receive vaccination administration certification. Due to the complexities of SARS-CoV-2, organizations such as the CDC and the Immunization Action Coalition (IAC) (www.immunize.org) provide healthcare professionals with up-to-date information and guidance regarding best practices with the COVID-19 vaccines as new information becomes available.11 During the first months of the COVID-19 vaccine use, a variety of errors in vaccine administration were reported to the CDC.12 Table 2 provides a partial listing of the frequency of the more than 400 vaccination errors reported.12 The CDC provides clinical guidance on how to handle vaccination administration errors. This information can be found at www.cdc.gov/vaccines/covid-19/onfo-by-product/clinicalconsiderations.html#Appendix-A.

Assessing Safety of COVID-19 Vaccines A variety of reporting systems are in place to track the occurrence of adverse effects and vaccination errors. The CDC operates websites for

this purpose, including the Vaccine Adverse Event Reporting System (VAERS) and the after-Vaccination Health Checker (V-Safe). In addition, the National Healthcare Safety Network has a monitoring system for healthcare providers and long-term care facility residents. VAERS is an online surveillance system in which vaccine providers and patients can report adverse events. Vaccine providers are required to report all COVID-19 vaccine administration errors to VAERS, whether or not the error was associated with an adverse event. Additionally, serious adverse effects (i.e. death, life-threatening adverse effects, cases that result in hospitalization, significant incapacity) and cases of multisystem inflammatory syndrome must be reported. Vaccine providers or patients can report the occurrence of adverse effects at vaers.hhs.gov/index. V-safe is primarily a smartphone-based reporting system set up to aid patients in informing the CDC if any adverse effects have occurred following COVID-19 vaccination. Patients can submit reports at vsafe. cdc.gov. After registering and entering data, vaccination information via email updates can be provided to the patient along with direct calls from the CDC depending on responses to web-based surveys. These national vaccine reporting systems help the CDC and the U.S. Food and Drug Administration (FDA) monitor adverse events reported by healthcare providers or the general public throughout the vaccination experience and are intended to lead to improvements in the vaccination process. References available upon request from the MPA office.

2021 July/Aug./Sept. | Vol. 59, Issue 3

— ON THE COVER —

Two Thousand and Twenty One

Michigan Pharmacy I

Economic Survey

n the 59th Annual Michigan Pharmacy Economic Survey, MPA received nearly 140 responses from pharmacists, pharmacy technicians and student pharmacists. Although the number of survey respondents has decreased for the year 2021, the data provided through this survey gives us a little insight into the trends occurring in the pharmacy workforce, including salary, benefits and job responsibilities. Complete responses were obtained from a total of 110 pharmacists, 17 student pharmacists and 13 pharmacy technicians. Responses were only excluded from the survey if they included incomplete information or data provided could not be interpreted accurately.

BY FARAH JALLOUL,

Pharm.D., M.B.A., director of professional development, Michigan Pharmacists Association

Table 1: Responses by Region Pharmacists

Student Pharmacists

Pharmacy Technicians

Total

REGION I

REGION II

REGION III

REGION IV

REGION V

108

138

Responses by Region

Each year the responses are classified based on an assortment of respondent characteristics such as age, gender and geographic region. The state was organized into five regions as shown in Figure 1. Response rate from each region was relatively equal, with the breakdown occurring as follows: Region I (13 percent), Region II (29 percent), Region III (28 percent), Region IV (26 percent) and Region V (42 percent). A full breakdown of respondents by region and category is shown in Table 1.

MichiganPharmacists.org

Annual Salary

Figure 1 demonstrates the percentage of pharmacist responses by practice site. The greatest proportion of respondents practiced in the health-system setting, followed by chain community pharmacy, then independent community pharmacy. A total of 9 percent identified as an independent pharmacy owner. It is important to note that some respondents identified with more than one practice site. In addition, Medicaid has changed the definition of a chain community pharmacy to seven or more pharmacies (rather than four or more pharmacies). The “other” category for pharmacist practice setting included: Medication Therapy Management (MTM) and clinical services vendor, association management and drug information publishing company.

— ON THE COVER — Figure 1 – Pharmacist Responses by Practice Site

Pharmacist Response by Practice Site (Out of 110) 3% 2%

n Ambulatory Care

n Chain Community Pharmacy (seven or more stores)

n Consultant Pharmacy n Clinic

n College of Pharmacy/Academia n Government

23%

n Health-System/Hospital n Home Infusion

14% 1 1

% %

n Independent Community Pharmacy n Long-term Care n Managed Care/Health Plan n Outpatient Retail Pharmacy

35%

n Pharmaceutical Industry n Specialty Pharmacy (Nuclear, Compounding, etc.) n Other

Figure 2 demonstrates the percentage of pharmacy technician responses by practice site. Similar to the pharmacist respondents, some identified with more than one practice site. The “other” category for pharmacy technician practice setting included: retail discharge pharmacy setting, 340B retail pharmacy and patient-centered medical home practice setting.

Figure 2 – Pharmacy Technician Responses by Practice Site

Pharmacy Technician Results by Practice Site (Out of 13) n Chain Community Pharmacy (four or more stores) n College of Pharmacy/Academia n Independent Community Pharmacy n Outpatient Retail Pharmacy

23%

n Other

Not represented (0%): n Ambulatory Care n Consultant Pharmacy n Clinic n Government n Health-System/Hospital

n Home Infusion

n Long-term Care n Managed Care/Health Plan n Pharmaceutical Industry n Specialty Pharmacy (Nuclear, Compounding, etc.) 2021 July/Aug./Sept. | Vol. 59, Issue 3

— ON THE COVER — Table 2 lists the mean annual salary of practicing pharmacists by gender and practice site.

Table 2 – Mean Annual Salary of Practicing Pharmacists by Gender and Practice Site Average Salary – Full Time Only (31 or more hours a week) Ambulatory Care Chain Community Pharmacy (seven or more stores) Consultant Clinic College of Pharmacy/Academia Government Health-system/Hospital Home Infusion Independent Community Pharmacy Long-term Care Managed Care Outpatient Retail Pharmacy Pharmaceutical Industry Specialty Pharmacy (Nuclear, Compounding, etc.) Overall:

Male 136,782 129,562 N/A N/A 130,348 N/A 138,129 N/A 110,000 125,000 N/A 139,500 175,000 125,000 134,369

Female 127,000 126,800 N/A N/A 116,215 131,500 131,629 N/A 117,000 N/A 170,000 123,000 142,500 158,800 134,444

Overall 131,891 128,181 N/A N/A 123,281 N/A 134,879 N/A 113,500 N/A N/A 134,000 158,500 133,450 134,406

Our calculated average salary for pharmacists in 2020 stayed nearly the same since 2019, with the average overall salary being approximately $134,406 (as compared to $130,529 in 2019). There continues to be discrepancies between male and female pharmacists, but those gaps are slowly closing, and many practice sections are seeing closer to equal salaries for males and females. Table 3 breaks down the average number of pharmacist hours worked per week by practice setting as well as the average hourly wage for full time pharmacists by practice setting.

Table 3 – Pharmacist Average Hours and Wage by Practice Setting Average Hours per Week 40 40 N/A N/A 44 40 40 N/A 40 43 50 40 42 43

Ambulatory Care Chain Community Pharmacy (seven or more stores) Consultant Clinic College of Pharmacy/Academia Government Health-system/Hospital Home Infusion Independent Community Pharmacy Long-term Care Managed Care/Health Plan Outpatient Retail Pharmacy Pharmaceutical Industry Specialty Pharmacy (Nuclear, Compounding, etc.)

Average Hourly Wage 68.69 66.76 N/A N/A 58.37 68.49 70.24 N/A 59.11 60.56 70.83 69.79 78.62 64.66

Table 4 shows average hourly wages for pharmacists and pharmacy technicians broken down by gender. Table 5 shows average annual salaries and hourly wages for pharmacists and pharmacy technicians broken down by gender. The average number of hours worked per week for both pharmacists and pharmacy technicians was 42 hours. When asked about a raise in 2020, 43 percent of pharmacists and 42 percent of pharmacy technicians reported a pay increase. The average raise was $3.78/hour for pharmacists and $1.25/hour for pharmacy technicians. Forty-two percent of pharmacists reported their last raise was about two years before their current raise, while 43 percent of pharmacy technicians claimed their last was less than a year prior to their current raise.

Table 4 – Average Hourly Salary by Respondent Type Pharmacist Salary Pharmacy Technician Salary

Male Hourly Wage 67 19.95

*Includes respondents that did not state gender

MichiganPharmacists.org

Female Hourly Wage 64 19.79

Overall Hourly Wage 65.5* 19.87*

Table 5 – Average Annual Salary by Respondents with Full Time Status (At Least 31 Hours a Week) Male Female Overall Annual Salary Annual Salary Annual Salary Pharmacist Salary 134,369 134,444 134,406 Pharmacy Technician Salary 40,219 39,896 40,058

— ON THE COVER — Employment Benefits

Table 6 presents a breakdown of employment benefits including insurance benefits, paid time off and additional fringe benefits. The majority of respondents indicated being offered some form of non-salary compensation. Seven percent of pharmacists and 17 percent of pharmacy technicians were not offered any insurance benefits, but nearly 44 percent of student pharmacist respondents indicated they received no insurance benefits. Student pharmacists were not compensated as much with fringe benefits, which could be due in part to the roles of student pharmacists as well as the part time nature of their positions in the pharmacy.

Table 6 – Employment Benefits for Pharmacists, Technicians and Students Pharmacist (n=99) Insurance Benefits Received Dental Coverage Disability Insurance Flexible Benefits Plan Health Insurance Life Insurance Long-Term Care Insurance No Insurance Benefits Optical Coverage Prescription Drug Plan Professional Liability Insurance Other Paid Time Off Benefits Received Bereavement Continuing Education / Professional Development Days Holidays No Paid Time Off Benefits Paid Maternity Leave Paid Paternity Leave Paid Time Off (Employer Doesn't Differentiate Use) Personal Days Sabbatical Sick Days Vacation Days Other Additional Benefits Received Allotment for Pharmacy Association Dues / Professional Memberships Business Mileage Reimbursement Child Care Services / Assistance Continuing Education / Professional Development Opportunities Discounts on Personal Purchases Flexible Schedule Job Sharing Licensure Fee Reimbursement Meals at Work for Reduced Rates No Additional Benefits Received Paid Board Certification Professional Attire Profit-Sharing Program Retirement / 401(K) Stock Purchase Options Tuition Assistance for Advanced Degree Use of Auto / Automobile Allowance Wellness Benefits Other

Percentage (%) 76 61 35 79 64 19 9 67 69 21 3 Percentage (%) 56 24 61 2 20 12 47 27 5 35 46 0 Percentage (%) 24 41 2 39 38 31 2 14 6 4 12 12 7 82 6 19 8 24 2

Student Pharmacist (n=16) Pharmacy Technician(n=12) Percentage (%) 67 33 8 75 42 17 8 50 5 0 0 Percentage (%) 42 0 83 8 17 0 42 42 N/A 42 33 0 Percentage (%) 33 25 8 25 25 33 0 25 0 0 N/A 25 0 0 75 0 0 8 17

Percentage (%) 25 0 0 31 6 6 25 6 19 6 0 Percentage (%) 31 6 6 25 25 6 9 0 N/A 19 0 0 Percentage (%) 0 0 0 0 6 38 0 0 0 6 N/A 13 6 0 25 0 19 0 0

Student Pharmacist Observations

While the response of student pharmacists was limited in this survey, the information these participants provided sheds light on how the profession may shift over the coming years as students begin to graduate. Figure 3 outlines the breakdown of respondents based on their year in pharmacy school. The majority of those who participated were in their P2 year in 2020. Of the students that responded, 88 percent indicated they are planning on practicing in the state of Michigan upon graduation, with 65 percent stating they are planning on pursuing a residency after graduation as well. Because many students are able to earn certifications to provide immunizations and point-of-care testing while in pharmacy school, 94 percent of respondents indicated they are certified to provide immunizations, but only 12 percent certified to administer point-of-care tests. In addition, a total of 12 percent indicated that they were certified to provide MTM.

2021 July/Aug./Sept. | Vol. 59, Issue 3

— ON THE COVER — The average number of hours a student pharmacist worked in 2020 was 12 hours a week, but respondent submissions ranged from five hours a week to 40. The average hourly wage for a student pharmacist was $16.65, but wages also ranged from $13 to $25 hourly. Because of the varying schedules of pharmacy students, their diverse backgrounds and previous education, how frequently they work and their role in the pharmacy, hourly wages may vary widely. Many students also received scholarships to fund their education, with 69 percent of student respondents reporting they received a scholarship. These awards ranged between $500 and $10,000.

Additional Observations and Conclusions

Figure 3 – Student Pharmacist Respondents by Year

Student Pharmacist Respondents by Year

12%

Additional Pharmacist Data: Forty-two out of 98 respondents reported that they have completed a post-graduate residency or fellowship. Thirty-one percent completed a post-graduate year 1 (PGY1) residency, 8 percent completed a PGY2 residency and 4 percent completed a fellowship. Table 7 and Table 8 provide additional detail regarding respondent pharmacist credentials. Other credentials include various bachelor’s degrees, medical science liaison, master’s in health administration and certified specialty pharmacy. Board certifications are increasing year-over-year and continue to expand into other facets of healthcare and pharmacy practice. Out of 103 pharmacist respondents, a total of 20 indicated that they have received a board certification. See Table 8 for a breakdown of board certifications. In addition to the credentials, 79 percent indicated they are certified to provide immunizations, 29 percent were certified to provide point of care testing and 40 percent are certified to provide MTM services.

18%

12% n P1 n P2 n P3 n P4

59%

Table 7 – Credentials of Respondent Pharmacists (n=100) CREDENTIAL

Table 8: Credentials of Respondent Pharmacists BOARD SPECIALTIES (N=20)

PERCENTAGE (%)

CREDENTIAL

PERCENTAGE (%)

PHARM.D.

B.S. PHARM

Ambulatory Care Pharmacy

BCACP

Cardiology Pharmacy

CDE

Compounded Sterile Preparations Pharmacy

J.D.

Critical Care Pharmacy

5 5

M.A.

Geriatric Pharmacy Infection Disease Pharmacy

M.B.A.

Nuclear Pharmacy

M.P.H.

Nutrition Support Pharmacy

M.S.

Oncology Pharmacy

PH.D.

Pediatric Pharmacy

Other

Pharmacotherapy

Psychiatric Pharmacy

Solid Organ Transplantation Pharmacy

MichiganPharmacists.org

— ON THE COVER — Figure 4 – Student Loan Debt for Pharmacists After Graduation

Student Loan Debt for Pharmacists After Graduation 5% 13%

n Less than $5,000

24%

n $5,001-$25,000 n $25,001-$50,000

n $50,001-$75,000 n $75,001-$100,000

17%

n $100,001-$125,000 n $125,001-$150,000 n More than $150,000

17%

Figure 5 – Remaining Debt for Pharmacists with Outstanding Student Debt

Remaining Debt for Pharmacists by Age 2% 10%

n 25 and Under n 26-30

n 31-40 n 41-50 n 51-60

42%

Additional Pharmacy Technician Data: Fifty percent of the respondents hold an associate degree, while 30 percent hold a bachelor’s degree. Out of the 13 respondents, 85 percent were Pharmacy Technician Certification Board (PTCB)-certified pharmacy technicians, while only one respondent identified as a PTCB-advanced certified pharmacy technician (CPhT-Adv). One respondent also identified as a Compound Sterile Preparation Technician (CSPT)-certified pharmacy technician. Sixty-seven percent of respondents reported that their employer pays a higher hourly rate to certified pharmacy technicians. The average increase in hourly wage was reported to be $.75. Student Loan Debt: Among the respondents, 79 percent indicated they graduated with debt. Of those, 5 percent owed more than $150,000 while 19 percent were somewhere between $100,001 - $150,000 with 34 percent of these respondents indicating that they had between $5,000 – $50,000 of debt upon graduation. The amount of debt upon graduation is listed in Figure 4. Out of those that indicated they graduated with debt, 21 percent noted that they are still paying off student loan debt. Figure 5 highlights the amount of debt currently held by respondents based upon age. Those 61 years of age or older reported no remaining student loan debt. Purchasing Budget: A total of 45 pharmacist respondents reported their average annual purchasing budget. Table 9 outlines the purchasing budget results. It is important to note that the data reported does not differentiate between different practice settings.

Relevant 2019 and 2020 Comparisons Table 9: Pharmacy Purchasing Budget (n=45) DOLLAR AMOUNT

PERCENTAGE (%)

< $2 million

> $2-4 million

> $4-6 million

> $6-8 million

> $8-10 million

> $10-50 million

$51-100 million

$101-250 million

$251-500 million

>$500 million

The 2020 economic summary included around 400 fewer participants than the 2019 survey, which may have affected observed differences between the two survey results. The average salaries for pharmacists were similar for the 2019 and 2020 data, with the pay gap between female and male pharmacists narrowing. Like pharmacists’ salaries, pharmacy technician salaries remained virtually unchanged in 2020. Thank you to everyone who participated in this year’s economic survey. Without your participation, this study would not be possible. Thank you for your continued involvement in MPA and your support in future endeavors.

2021 July/Aug./Sept. | Vol. 59, Issue 3

— LEGAL INSIGHTS —

COMPLIANCE PROGRAMS

One Size Does Not Fit All D

oes your organization have a written compliance document as required by federal law? If so, was it purchased from a vendor who sent you a pre-packaged product that basically just inserted your pharmacy’s name and address? Was it purchased from a company outside of Michigan with no lawyer on staff? Whether you have one of these documents, or you don’t have one at all, you are guaranteed to be out of compliance with the law to at least some degree, and that means you are facing significant legal risks and potential financial penalties and sanctions.

What is a compliance program?

BY JULIE JANEWAY,

MSA, JD; Associate principal, Foley, Baron, Metzger and Juip, PLLC

A compliance program is an organization-specific document that declares compliance or intent to comply with legal and accreditation requirements, and is a multifaceted infrastructure of rules, policies, training, penalties, internal controls, and prevention and response protocols that will reduce the incidence of noncompliance, detect it faster when it happens and attempt to prevent its recurrence. The purpose of a compliance program is to bring the organization into compliance with the law by deterring, preventing and correcting fraud, waste, abuse and other forms of noncompliance, and to set forth the framework and internal controls for an operational and ongoing employee system of compliance. It also serves as an important legal defense document if the organization is found to be in alleged violation of the law or violation of other requirements to which the organization is subject or has agreed by contract. Numerous federal and state laws require significant and tedious compliance efforts, and it can be daunting to keep track of all of them. Having a thoughtful and well-crafted compliance document is a start, but the document itself does not get the job done. Here are just a few of the reasons why compliance programs are not one-size-fits-all: • It requires a document and fully functioning program created specifically for the needs, risks and legal issues of the pharmacy – something pre-packaged compliance documents purport to provide but don’t fully achieve. • No two pharmacies are the same: size, operational features, location, restrictions, limitations and other aspects differ. • Each pharmacy often has very complex legal risks, issues and requirements, and pre-packaged documents often miss critical legal provisions and protections. • The document must address federal law, but also state-specific laws and regulations. These are often missed or improperly addressed by non-lawyer providers of pre-packaged documents.

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• Adding a pharmacy name or a few employee names does not tailor the document to the needs of the specific pharmacy and is often evidence that the pharmacy does not have a functional compliance program. • Pharmacies within a chain of stores may not all have the same needs either, so each, or at least some, should have their own documents that coordinate with the compliance program established at the corporate level. • Generic documents try to cover too many different types of circumstances to be effective and make the document unreadable and unusable by employees at the pharmacy. • “Kitchen-sink” documents tend to undermine the legitimacy and compliance nature of the document and its use as a legal defense document. Legal precision, accuracy, a tailored approach, and a daily, operational compliance program is what gets the job done. In the unlikely event that your pharmacy is found to be out of compliance, and there are sanctions ranging from mildly aggravating to potentially catastrophic, your “compliance program” vendor is not going to help you. By using a compliance attorney, an attorneyclient relationship is already established. As a result of having drafted your compliance document/program, your attorney is fully aware of your organization’s legal environment, the contents of the compliance document and the relevant law. So instead of having a panic attack, all you have to do is call your attorney. Your defense is ready to hit the ground running. There are many non-attorney vendors who can provide services that are very helpful to your organization for a low cost. But using a non-attorney vendor to address your legal compliance program is not the place to save money, because it will cost you exponentially in the end. It’s just a matter of time. In the next issue – just in time for Halloween – we will explore the variety of annoying, chilling or down-right horrifying consequences that can result from having no compliance program, having a poorly-crafted one and failing to keep your compliance in check.

2021 July/Aug./Sept. | Vol. 59, Issue 3

— MSHP PRESIDENT —

ADAPTING TO ADVANCE HEALTH-SYSTEM PHARMACY

knew it would be a personal and professional challenge to be president of MSHP, but when I accepted a nomination to be on the ballot in the summer of 2019, I was blissfully unaware of just how much of a challenge I would face: develop a new three-year strategic plan, create committee charges to help guide our organization to achieving goals within that plan, complete our state affiliation renewal with the American Society of HealthSystem Pharmacists (ASHP) and, most challengingly, figure out how to do all of that amidst a global pandemic.

BY REBECCA MAYNARD, Pharm.D.,

pharmacy manager, Bronson Methodist Hospital, Kalamazoo; president, MSHP

In the early days of the pandemic, few thought it would become as life-altering as it has, in every realm of our existence, both personally and professionally. Prior to our annual meeting last October, I toiled over what the theme should be for my presidency year, looking to thoughts from other pharmacist and non-pharmacist leaders to find something meaningful in a time of turmoil and uncertainty. During that search, I was struck by this quote by Kakuzo Okakura in The Book of Tea – “The art of life lies in a constant readjustment to our surroundings.” Sure, we can take the basic step of accepting what is happening, but embracing it is to accept those changes willingly. Last summer, the MSHP Board of Directors approved a new three-year strategic plan for 2021-2023. Our strategic priorities of Pharmacy Practice Advancement, Michigan Patients and Their Care, and MSHP Members remain the same, but our goals and objectives have been revised as we continue to evaluate what our organization needs to focus on in our efforts to achieve our mission and vision. To make progress on and hopefully accomplish our objectives, MSHP’s highly dedicated committee members have been

Within our strategic priority of Michigan Patients and Their Care, one goal is for MSHP to positively impact the health and well-being of Michigan patients. One objective for that goal is to increase patient utilization of pharmacy services across the continuum of care, especially in underserved populations. In a pre-pandemic world, we all experienced roadblocks to bringing things like telepharmacy to fruition in a way that enhanced patient care. In the last year, however, we have seen an incredible uptake of virtual platforms that make this type of care possible. Thus, we are embracing the need for pharmacy services in a different format than we have typically provided and adapting our processes to meet those needs. Many of the ASHP Practice Advancement Initiative (PAI) 2030 goals, especially in technology and data science, are so much more achievable in the current virtual climate. I look forward to MSHP’s Annual Meeting this fall when we will hear experts and thought-leaders from across the country share stories of how they have embraced the challenges and opportunities presented over the last year and adapted their processes to improve the well-being of our communities. I encourage you to engage with MSHP’s efforts – read the MSHP Monitor to stay connected with what’s happening in health-system pharmacy across the state, engage with an MSHP or MPA committee, and join us for our annual meeting in October. I welcome all of you to join MSHP in achieving our mission of providing leadership, support and a collective voice for our members as we practice and advance the pharmacy profession to achieve desired health outcomes through optimal medication use. While we recognize the amazing challenges remaining in the year ahead, we have also been given an incredible

“The art of life lies in a constant readjustment to our surroundings.” — KAKUZO OKAKURA, The Book of Tea

diligently working on their committee charges, coming together formally at Committee Days in January and May. Through the MSHP Monitor, our colleagues have shared their stories of practice changes, lessons learned and inspired thoughts. I have been uplifted many times over the last year reading these articles, finding camaraderie through our colleagues’ stories and experiences.

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opportunity to advance our roles in patient care and population health. My theme for this year is to take that opportunity head on, to accept it willingly, to embrace it and to adapt our current processes to ones that can help us identify patients in need of pharmacist care, find and eliminate health inequities, and optimize medication use. References available upon request from the MPA office.

— MSHP FOCUS —

PHARMACISTS DEVELOP AWARD-WINNING MODEL

Cardiac risk assessment program designed to improve covid-19 patient safety BY MELISSA MURPHY,

Pharm.D., BCPS;

MATTHEW RICO,

Pharm.D.;

THOMAS BREEDEN, Pharm.D.,

DAVID BLAIR,

Pharm.D., BCPS;

MONICA ALLEN,

Pharm.D.

s of July 2021, more than 189 million cases of coronavirus disease 2019 (COVID-19) were reported worldwide.1 More than one year into the pandemic, uncertainty persists regarding optimal management of patients with COVID-19. While the increase in patient volume and scarcity of resources has been a strain on healthcare systems, the pandemic has also allowed for opportunities for medical providers to collaborate in new ways. At Ascension Genesys Hospital, we recognized an opportunity to advance pharmacy services by implementing a pharmacist-driven cardiac risk monitoring program for patients receiving specific medications for COVID-19. The U.S. Food and Drug Administration (FDA) authorized the temporary use of chloroquine and hydroxychloroquine in March 2020 during the initial surge of the pandemic for treatment in hospitalized patients when clinical trials were not available or when participation was not feasible.2 At that time, the National Institutes of Health (NIH) COVID-19 Treatment Guidelines Panel did not recommend for or against the use of these agents for the treatment of COVID-19, but noted that if employed, patients should be monitored for QTc prolongation, among other adverse effects.3 The NIH Panel also recommended against, outside of the context of a clinical trial, the use of the combination of hydroxychloroquine and azithromycin due to the potential for toxicities and recommended against the use of lopinavir/ritonavir because of “unfavorable pharmacodynamics and negative clinical trial data.”3 Because of the widespread use of these QTc-prolonging agents in the early stages of the pandemic, various organizations, including the FDA, the American Heart Association (AHA), the American College of Cardiology

(ACC) and the Heart Rhythm Society (HRS), issued guidance for developing risk monitoring and mitigation strategies for the use of these medications in the treatment of patients with suspected or confirmed COVID-19 in the inpatient setting.4-6 Using the AHA/ACC/ HRS recommendations as a framework, a pharmacist and electrophysiology (EP) service was implemented to monitor patients receiving hydroxychloroquine and/or lopinavir/ ritonavir for the treatment of COVID-19 at our institution. The pharmacist practice model at Ascension Genesys Hospital features decentralized clinical pharmacy services. Pharmacists are embedded in patient care units throughout the institution. Daily responsibilities encompass a number of direct and non-direct patient care activities, such as completing electronic medication order verification, participating in patient care rounds with a multidisciplinary medical team, performing bedside patient counseling for targeted chronic disease states and completing pharmacokinetic and protocolized dosing adjustment for several medications. The standing recognition of pharmacists as established members of

Pharmacy Team Wins MSHP Professional Practice Award The pharmacy team at Ascension Genesys Hospital in Grand Blanc, Mich. was awarded the 2020 Michigan Society of Health-System Pharmacists (MSHP) Professional Practice Award for their development and implementation of a cardiac risk monitoring program. At a time of conflicting recommendations and limited information about the use of hydroxychloroquine to treat coronavirus disease 2019 (COVID-19), this pharmacy team created a rigorous monitoring program to improve patient outcomes, establishing a valuable model and highlighting pharmacists’ role within the healthcare team. The MSHP Professional Practice Award recognizes and honors a pharmacist, group of pharmacists or organization for involvement and participation in an innovative project that contributes to professional practice. The winning pharmacist team included Drs. Monica Allen, David Blair, Thomas Breeden, Melissa Murphy and Matthew Rico.

The U.S. Food and Drug Administration (FDA) authorized the temporary use of hydroxychloroquine in March 2020, but the National Institutes of Health abstained from recommending it, warning against potential toxicities and negative clinical trial outcomes. The American Heart Association and other groups recommended cardiac risk monitoring, due to the known risks. However, no publications about successful monitoring strategies of COVID-19 patients taking these drugs yet existed. This pharmacist-driven program has and will continue to contribute to the wider understanding and potential treatment of COVID-19, while also establishing a framework that may be applied to monitoring programs in the future. Through its success, this model benefits patients, the pharmacy profession and the wider medical field, while promoting innovation and advancement among practitioners. 2021 July/Aug./Sept. | Vol. 59, Issue 3

— MSHP FOCUS — Figure 1. Cardiac Risk Assessment Algorithm Designed and Employed by Pharmacists and EP for Patients Receiving Specified Antimicrobial Therapies for COVID-19

HARD STOP Hold dose, contact EP

STOP

Flag for daily EP review, give dose

PAUSE

Correct underlying cause, give dose

VERIFY

• History of Long QT syndrome (LQTS) • Major CV condition: ASC/MI (in previous 7 days), VT/VF (in previous 24 hours), hypertrophic cardiomyopathy, dilated cardiomyopathy (EF < 40%), or a pacemaker as noted in GEMS AND QTc ≥ 480 ms • Severe bradycardia (<40 bpm) • QTc ≥ 500 ms on baseline EKG • Severe electrolyte abnormalities: K < 3.0 or ≥ 6, Mg < 1.1, Ca < 7.0 • QTC increase by ≥ 20 ms if previous QTc is ≥ 450 ms

• If QTc ≥ 450 ms AND any ONE of the following: o Non-modifiable concomitant QTc-prolonging medication o Impaired hepatic (AST/ALT >5x ULN) or renal function (CrCl ≤ 15 or ESRD) o Tisdale score ≥ 11 • QTc ≥ 480 ms

• If QTc ≥ 450 ms AND oM odifiable concomitant QTc-prolonging medication – seek alternative with managing physician as appropriate • Electrolyte abnormalities – correct all electrolyte abnormalities per protocol

• If none of the above, verify hydroxychloroquine 400 mg twice daily for 2 doses, followed by 400 mg daily for 4 doses OR lopinavir/ritonavir 400 mg/100 mg every 12 hours for 7 days

the inpatient health care team uniquely positioned our department to implement patient safety strategies aimed at reducing patient harm associated with medications used for the treatment of COVID-19. The EP and pharmacy departments collaboratively designed an algorithm (Figure 1) for the monitoring of patients being treated with hydroxychloroquine or lopinavir/ritonavir for COVID-19. The algorithm was based on the monitoring recommendations from the AHA/ACC and HRS.5,6 The algorithm required that a baseline assessment of each

patient be completed and daily follow-up monitoring be conducted prior to the administration of each dose of the prescribed medication. The baseline assessment of each patient included the calculation of the Tisdale score, cardiac-focused past medical history, presence of a pacemaker or implantable cardioverter defibrillator (ICD), baseline QTc on electrocardiogram, baseline electrolyte values, renal function and evaluation of active orders for concomitant QTc prolonging medications.7 The primary source used for identification of concomitant QTc prolonging medications was the CredibleMeds QTDrugs List.8 The risks associated with QTc prolongation can be mitigated by ensuring expeditious optimization of serum potassium, magnesium and calcium concentrations. Daily electrolyte monitoring and supplementation was thus a primary pharmacist function as part of the cardiac risk assessment and mitigation activities. The algorithm allowed for “per-protocol” pharmacist electrolyte laboratory monitoring and supplementation. This was not previously permitted for the pharmacist to perform independently without prescriber approval. In order to standardize electrolyte replacement ordering and supplementation by the pharmacist, an electrolyte replacement protocol was developed and implemented (Table 1). The implementation of this algorithm, including the use of “per-protocol” ordering, required approval from the key prescriber stakeholders that would be providing patient care, as well as hospital leadership. The pulmonary critical care and infectious diseases prescribers were in support of a pharmacist-driven monitoring program and use of the algorithm to ensure that patient safety was not compromised. The monitoring program and algorithm was also presented to and approved by the hospital COVID-19 incident command center, which consisted of members of hospital administration and key department chairs, including EP.

Serum Potassium (mEq/L)

PERCENTAGE (%)

3.7 - 3.9

Potassium chloride 20 mEq orally twice daily for two doses

3.4 - 3.6

Potassium chloride 20 mEq orally twice daily for two doses AND potassium chloride 10 mEq i.v. administered over one hour for four doses

3.0 - 3.3

Potassium chloride 40 mEq orally twice daily for two doses AND potassium chloride 10 mEq i.v. administered over one hour for four doses

< 3.0

Hold hydroxychloroquine and/or lopinavir/ritonavir and contact physician

Serum Magnesium (mg/dL)

Ordered Supplemental Dose

1.4 - 1.9

Magnesium sulfate 2 g i.v.

1.1 - 1.3

Magnesium sulfate 4 g i.v.

< 1.1

Hold hydroxychloroquine and/or lopinavir/ritonavir and contact physician

Serum Corrected Calcium (mg/dL)

Ordered Supplemental Dose

< 7.5

Calcium gluconate 1 g i.v.

Pharmacists initiated the monitoring process for any patient newly prescribed treatment during their shift and were also responsible for the ongoing monitoring of patients who were already receiving a course of treatment. During the pharmacist’s initial and ongoing assessment of patients, the algorithm was utilized to assign each patient a daily cardiac risk level. Patients deemed to be low risk required no intervention from EP. Patients who were not low risk but who possessed modifiable risk factors (e.g., electrolyte abnormalities or concomitant non-essential QTc prolonging medications) were considered at moderate cardiac risk. Modifiable risk factors for these patients were corrected, in collaboration with the primary care team if applicable, and these patients were not formally reviewed by EP. Patients who were deemed to have significant risk factors that were not immediately modifiable or who had a past medical history that was associated with a substantial risk for QTc prolongation required EP review. EP provided a clinical recommendation regarding the patient’s therapy for the day. The EP team member or pharmacist would propose offending therapy discontinuation, or a hold therapy and reevaluate strategy with the primary team providing patient care, and the pharmacist would communicate the treatment plan to the patient’s nurse. To document clinical activities, the pharmacist placed a provider assessment note in the electronic medical record daily for each patient, regardless of level of risk. The note contained the patient’s most recent QTc measure (within 48 hours), recent past QTc measures, detailed the risk factors for QTc prolongation, described any actions taken and provided information about the medication administration plan for the day.

< 7.0

Hold hydroxychloroquine and/or lopinavir/ritonavir and contact physician

A core group of pharmacists involved with the design of the program were tasked with developing a cloud-based monitoring form and web-

Table 1. Pharmacist-Driven Electrolyte Replacement Protocol for Patients Receiving Specified Antimicrobial Therapies for COVID-19

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— MSHP FOCUS — based training documents. This allowed for management of patients in real time and offered a simplified handoff process between pharmacists. Each change in the form was archived with the ability to reference later if necessary. Training sessions were hosted virtually due to the need to maintain social distancing. Within the first week of implementing the monitoring program, a total of 14 pharmacists had been trained, which comprised approximately 50 percent of the inpatient clinical pharmacist team. While pharmacists participating in the cardiac risk assessment program incorporated new clinical care activities into their practice, other pharmacists were required to modify their practice too. This included providing support for the designated monitoring program pharmacists via coverage of all patient care responsibilities and order verification tasks for up to three to four hours each day, depending on the number of patients actively receiving treatment for COVID-19 with monitored medications. This program provided the pharmacists at our hospital with critical responsibility for the care of COVID-19 patients and further established the pharmacist’s role as a vital member of the healthcare provider team. Pharmacist cardiac risk assessment and monitoring resulted in the discontinuation of treatment in several patients who were at high risk of developing torsades dysrhythmias, potentially preventing life-threatening events. Working collaboratively with EP to develop the monitoring program not only established rapport with this sub-specialty practice group, but also built prescriber confidence in the role of the pharmacist as a crucial influencer of medication-related outcomes and as an advocate for medication and patient safety.

SAVE THE DATE!

“Terror in Transylvania” MURDER MYSTERY FUNDRAISER The Michigan Pharmacy Foundation will host a murder mystery event: “Terror in Transylvania,” on Saturday, Oct. 16, 2021, at 6:30 p.m. We hope you’ll enjoy the opportunity to invest in the future of the profession while dressing up before Halloween!

References available upon request from the MPA office.

Look for more information in the Michigan Pharmacists Association regular newsletters!

Certified Compounded Sterile Preparation Technician Exam Study Guide Customer Testimonial: Jordan Linkenberg, CPhT, CSPT “Without the Certified Compounding Sterile Preparation Technician Exam Study Guide, I would never have passed my CSPT exam! It is absolutely worth every penny. I wanted a study guide that went in-depth and truly prepared me for what was to come on the exam. I highly recommend this to every technician wanting to go forth in their journey to become an advanced technician, like myself. This study guide is also helping me prepare for the Hazardous Drug Management Certificate at this very moment!” The Certified Compounded Sterile Preparation Technician (CSPT) Exam Study Guide (2020) is intended to assist pharmacy technicians with the successful preparation for the CSPT exam. A 75-question practice exam, including answers and explanations, is provided at the end of the study guide to simulate the CSPT exam.

Buy the MPA Certified Compounding Sterile Preparation Technician Exam Study Guide and other educational materials on MPA’s website at:

www.MichiganPharmacists.org/onlinestore

2021 July/Aug./Sept. | Vol. 59, Issue 3

— COVER YOUR ASSETS —

UMBRELLA

COVERAGE

Protecting Your Assets from the Unexpected An umbrella policy can be a foreign concept to many. Most of us have a general understanding of your home and auto insurance policies, but the benefits of an umbrella policy can often be unknown or not understood. Umbrella policies benefit both the personal and commercial customer with added liability protection and casualty insurance. It protects against exposures like automobile, dog bites, slip-and-falls on owned property and personal liability. It protects assets from liability suit or paying out-of-pocket if there were a catastrophic liability lawsuit. It provides legal defense, and in some instances, may provide coverage when the primary policy does not.

Here are some actual claim examples: BY RON DEVERS,

CIC, CPIA, manager, PSI Insurance Agency

• A policyholder was at a stop sign while driving and pulled out in front of another vehicle, not realizing the other driver did not have a stop sign. The operator of the other vehicle sued to cover extensive medical bills.

• A policyholder was in a friend’s wedding and hung his tuxedo on the sprinkler head in his room. The hanger was hit by the door, breaking the sprinkler and causing water damage. The hotel sued for the costs of damage to their property.

• An insured’s daughter hated math class and made disparaging remarks about her teacher online. The teacher sued for personal injury, and the parent’s policy paid $750,000.

These are just a few examples of how an umbrella can protect you and your family or your business from liability lawsuits. Give PSI Insurance Agency a call to discuss your umbrella and other insurance needs.

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— THAT’S MY PHARMACIST —

Join the Michigan Society of Health-System Pharmacists and the Michigan Pharmacists Association in educating the public by utilizing the “That’s My Pharmacist” campaign in your pharmacy! This campaign includes various flyers focused on important health topics, relevant to health observances for each month of the year as well as additional awareness campaign resources to share with your patients. These flyers work to educate patients on the conditions that pharmacists can help with, as well as questions that patients can ask their pharmacists. Find all the available campaign materials for display in your pharmacy at www.ThatsMyPharmacist.com.

July 28 is World Hepatitis Day. Since 2016, Michigan has seen elevated cases of hepatitis A throughout the state. Use this day of observance to educate your patients regarding the dangers of hepatitis, how to avoid contracting it and patient options for vaccination if needed.

The remaining health observance flyer topics to be included on the website are:

August is National Immunization Awareness Month. Use this month of observance to get your patients geared up for the next flu season and on board with all recommended immunizations. Use this flyer to educate your patients regarding the ways immunizations protect them and how to access all necessary vaccinations.

• November - American Diabetes Month & COPD Awareness Month

September is Healthy Aging Month. Use this month of observance to discuss with older patients how to lower prescription costs and optimize their medication treatment as well as addressing any questions these patients may have regarding their medication treatments.

• October - American Pharmacists Month & Health Literacy Month

• December - National Influenza Vaccination Week & National Hand Washing Awareness Week Visit www.ThatsMyPharmacist.com to access a flyer for each of the observances above. Print off the flyer and share the key information included with your patients! The details included in these resources will help your patients further understand the importance of utilizing their pharmacist as a vital member of their personal healthcare team.

If you would like to participate in the campaign, have any additional questions or would like to provide a suggestion for the campaign, please contact Mary Beth Wardell, communications manager, at marybeth@ michiganpharmacists.org. We look forward to helping you achieve your pharmacy goals! 2021 July/Aug./Sept. | Vol. 59, Issue 3

— CE HOMESTUDY —

HEALTH EQUITY IN THE PHARMACY

OVID-19 and the year 2020 brought about many changes in the world. One of those changes was the footage of George Floyd’s death while in the custody of Minneapolis police, which sparked a worldwide conversation about racial injustice. This movement opened a larger contextual discussion of racial disparities in several different areas, including health care. Dialogue about differences in health care and health outcomes between populations has begun to influence professional practice.

BY ZACHARY R. MUELLER, Pharm.D.,

MPA/PSI executive fellow, Michigan Pharmacists Association

Learning Objectives: 1. D escribe health equity, health disparity, social determinants of health, and implicit bias 2. D iscuss the impact of health disparities on patients 3. E xamine the role of healthcare providers in promoting health equity 4. I nvestigate actions for pharmacy professionals to take that reduce healthcare inequities

MichiganPharmacists.org

Healthcare professionals are entrusted to provide the best care to all patients regardless of race, gender, socioeconomic status, disability status, age, or any other diversity dimension. However, COVID-19 disproportionately affected minority populations with regard to cases, hospitalizations, and deaths.1-3 The inordinate disease burden on these communities attracted a lot of attention in 2020, but health disparities are hardly a new problem. The Centers for Disease Control and Prevention (CDC) has been collecting data regarding health indicators such as ethnicity, gender, family income, geographic location, disability status, sexual orientation, and age, since the 1990s.4 The attention is currently focused on race and ethnicity, but disparities exist across all health indicators, including race and ethnicity. Healthcare disparities are not one-dimensional. Many patients belong to multiple disadvantaged social groups, a concept called intersectionality. Intersectionality is defined by the Oxford Dictionary as, “the interconnected nature of social categorizations such as race, class, and gender as they apply to a given individual or group, regarded as creating overlapping and interdependent systems of discrimination or disadvantage.”5 Pharmacists and pharmacy technicians should hesitate to assume they know a patient’s social identity, because it underestimates the extent and complexity of a patient’s situation, especially if they fit into multiple disadvantaged groups.

Defining the Problem If healthcare professionals are committed to the best care for all patients, why do health disparities occur between populations? This is where health disparity, social determinants of health, health equity, and implicit bias come into play. Before discussing these terms, it is best to define them. While commonly utilized in health care, every healthcare professional may not have a clear understanding or be able to differentiate between them. Authors have assigned different meanings to these words, which are all interconnected but have distinct differences.

Health Disparity The CDC defines health disparities as, “preventable differences in the burden of disease, injury, violence, or opportunities to achieve optimal health that are experienced by socially disadvantaged populations.”6 Although discussions have been primarily focused on ethnic and racial disparities, other diversity dimensions include gender, education, disability status, geographic location, sexual orientation, and socioeconomic status. Socially disadvantaged individuals are defined in the Code of Federal Regulations as having been subjected to racial or ethnic prejudice or cultural bias within American society because of their identities as members of groups and without regard to their individual qualities, stemming from circumstances beyond their control.7 Health disparities manifest for various reasons, including poverty, environmental threats, inadequate access to health care, and educational inequalities.

Health Equity There is often discussion about equal treatment, but health care is shifting to equitable treatment. When discussing the treatment of patients, health equality would be the equal treatment of all patients. In contrast, health equity would provide the required care for each

— CE HOMESTUDY — patient to attain equal outcomes or at least the best health outcomes possible for each individual patient. So, rather than treating each patient the same, to provide equitable care, healthcare professionals need to account for individual differences between patients and personalize that care to reach the same outcomes. Health professionals need to address the varying social determinants of health that may produce unequal outcomes. To provide health equity, healthcare professionals must first identify what barriers their patients may face and how social context influences health.

Social Determinants of Health Healthy People 2020 defined social determinants of health as the conditions and environments in which people live, grow, work, and age that affect health, quality of life, risks, and functions.8 Health outcomes cannot be purely defined by biology. For example, in the case of COVID-19, some of its effect on minority populations can be attributed to urban areas with crowded neighborhoods and households.9 The social aspects of patients’ lives can alter their health outcomes. Another example is patients that live in “food deserts,” which are areas with a lack of access to nutritious food. Living in a food desert, especially if the patient does not have reliable transportation, can affect their nutrition status and overall health. Healthy People 2020 identified five key areas of social determinants of health: economic stability, education, social and community context, health and health care, and neighborhood and built environment. Each of these five key areas were broken down further into key issues that represent factors affecting the overall health of patients: • Economic Stability - Employment - Food Insecurity - House Instability - Poverty • Education - E arly Childhood Education and Development - Enrollment in Higher Education - High School Graduation - Language and Literacy • Social and Community Context - Civic Participation - Discrimination - Incarceration - Social Cohesion

• Health and Health Care - Access to Health Care - Access to Primary Care - Health Literacy • Neighborhood and Built Environment -A ccess to Foods that Support Healthy Eating Patterns - Crime and Violence - Environmental Conditions - Quality of Housing To further explore these key areas, visit HealthyPeople2020.gov. A common issue seen across health care is health literacy. Literacy as a general concept means the ability to read and write a specific language, such as English. Health literacy is the ability of an individual to obtain, communicate, process, and understand basic health information and services to make health decisions. Some patients may not be able to understand the information in front of them due to language barriers, while other patients may be learning disabled or have poor vision that makes it hard to read small print. For example, an individual whose first language is Spanish may not be able to read medical information given in English; subsequently, they do not take their medications correctly. In addition, individuals with poor eyesight may not be able to read the warning on a medical vial written in small print. This could lead to adverse events, causing worsened health and additional medical costs. Another example is a person working two jobs to support their family, they may not have time to prepare fresh foods, so they may purchase more highly processed foods that are higher in salt content. This increases their risk of hypertension and their likelihood of cardiovascular complications. Recognizing the different needs of patients is essential for providing health equity. Treatment options and resources should be available for a variety of patient situations. The person with low health literacy may need resources available in a different language, and the person working two jobs may need information about healthy recipes that do not take long to make.

Bias While the social context of a patient’s life is external, internal bias from healthcare professionals can also affect health outcomes. A pharmacist or pharmacy technician’s bias is a factor that can be

controlled or at least understood. Bias is a prejudice in favor of or against one thing, person, or group compared with another, usually in a way that’s considered to be unfair.10 It can be broken down into either explicit or implicit bias.

Explicit Bias One definition of explicit bias is, “the attitudes and beliefs we have about a person or group on a conscious level. Much of the time, these biases and their expression arise as the direct result of a perceived threat. When people feel threatened, they are more likely to draw group boundaries to distinguish themselves from others.”11 The line that is drawn decides who is in and who is out of the group. Criteria for inclusion can be based on race, culture, gender, religion, etc. When these boundaries are formed, some people will fit into the group and share in the privileges of the group, and others will be excluded and denied the privileges of that group. These privileges can include access to providers, health insurance, quality food, employment, voting, loans, etc. Explicit bias is generally the type of bias that people think of when they think of discrimination and racism. It can manifest as overt negative behavior through physical and verbal harassment or exclusion.12-14 Social exclusion is the lack of or denial of resources, opportunities, or rights that would normally be offered to members of a different group. People could be excluded based on other factors, such as race. For example, a pharmacy owner might refuse to hire Hispanic technicians based on race; however, that is an obvious legal violation. Please visit www.MichiganPharmacists.org/ education/online to read the rest of this article and view tables. Important Information Regarding Continuing Education Credit Upon completion of this activity, participants must complete an online evaluation. Participants will receive pharmacy continuing education (PCE) credit through CPE Monitor, a national collaborative effort by ACPE and the National Association of Board of Pharmacy (NABP) to provide an electronic system for pharmacists and pharmacy technicians to track their completed PCE credits. MPA, as an ACPE-accredited provider, is required to report pharmacist and pharmacy technician PCE credit using this tracking system. Pharmacist and pharmacy technician participants must provide their NABP e-Profile identification number and date of birth (in MMDD format) when they complete a PCE activity. It will be the responsibility of the participant to provide the correct information. If this information is not correctly provided, NABP and ACPE prohibit MPA from issuing PCE credit. Online access to their inventory of completed credits will allow pharmacists and pharmacy technician to easily monitor their compliance with PCE requirements and print statement of credit. Partial credit will not be awarded. If you have not yet signed up for CPE Monitor, go to https://nabp.pharmacy/programs/ cpe-monitor/. For more home study activity option for pharmacists and pharmacy technicians, visit https://www.michiganpharmacists.org/ education/online. Michigan Pharmacists Association is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. ACPE Universal Activity #0112-0000-21-002-H04-P & #0112-0000-21-002-H04-T, 1.0 contact hour, Initial Release Date: 5/4/21; Expiration Date: 5/4/24, Knowledge-based Activity. Disclosure – The author has indicated no conflicts of interest related to this topic.

2021 July/Aug./Sept. | Vol. 59, Issue 3

340B Third Party Administrator Data Breach of 1.6 Million Patients

WOULD YOU BE PREPARED?

n Feb. 19, 2021, a 340B Third Party Administrator (TPA) became aware of unusual activity within their system and discovered unauthorized access had occurred on Feb. 6. The 340B TPA’s investigation of the breach was completed around March 19, and they determined the following types of information had been accessed: first name, last name, date of birth, prescription information and medical record number.

BY TRENTON THIEDE,

Pharm.D., MBA, president, PAAS National®, expert third party audit assistance and FWA/HIPAA compliance

As a Business Associate (BA) of the pharmacy, the 340B TPA has an obligation to notify the affected pharmacies per the Health Information Technology for Economic and Clinical Health (HITECH) Act of 2009 42 USC 17932 sec 13402(b).1 Ultimately, it is the pharmacy’s responsibility, as the Covered Entity (CE), to ensure all notifications are made as required under the HITECH Act. The CE also carries the burden of maintaining proof as per section 13402(d) (2). The Pharmacy Audit Assistance Service (PAAS National®), a community pharmacy consulting firm based in Stoughton, Wis., has seen these breaches affect anywhere from 15 to more than 700 patients per pharmacy. It is imperative that pharmacies are aware that the proper response entails far more than sending out notification letters. While providing guidance to our Fraud, Waste and Abuse (FWA)/Health Insurance Portability and Accountability Act (HIPAA) Compliance Program members, numerous questions must first be answered, to ensure the appropriate actions are taken. Would your pharmacy know how to answer these important questions?

1. H ow long do I have to report the breach to the patient, U.S. Health and Human Services (HHS) Secretary and media (if applicable)?

2. W hat must be done if one or more of the notification letters were undeliverable? What about ten or more?

3. W hat happens if a breach exceeds 500 patients?

4. I s the Business Associate acting as an agent of the Covered Entity? Why does that matter?

5. W hat is considered a “prominent media outlet” per section 13402(e)(2) of the HITECH Act?

Having a HIPAA expert on your side to navigate through the turbulent waters of a data breach can help ensure that all appropriate steps are taken, and deadlines are not missed. Utilize your HIPAA/FWA Compliance membership and reach out to PAAS for additional guidance by calling 608-873-1342 or emailing info@paasnational.com. Additional HIPAA/FWAC benefits include a customized policy and procedure manual (with breach-related guidance in section 10.14), online HIPAA/FWA training, daily OIG/GSA checks and much more. PAAS National® is committed to serving community pharmacies and helping keep hard-earned money where it belongs. Contact us today at (608) 873-1342 or info@paasnational.com to see why membership might be right for you. ©2021 PAAS National® LLC All Rights Reserved REFERENCES: 1. https://www.hhs.gov/sites/default/files/ocr/privacy/hipaa/understanding/coveredentities/hitechact.pdf

MichiganPharmacists.org

2021 July/Aug./Sept. | Vol. 59, Issue 3

MichiganPharmacists.org