North Carolina Pharmacist Volume 102 Number 3

North Carolina Pharmacist Volume 102 Number 3 Summer 2021

Advancing Pharmacy. Improving Health.

Working Together To Achieve A Shared Vision And Overcoming Challenges Facing Our Profession.

Join us today at ncpharmacists.org

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

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

www.ncpharmacists.org EDITOR-IN-CHIEF Tina Thornhill

North Carolina Pharmacist Volume 102 Number 3

Summer 2021

Inside

LAYOUT/DESIGN Rhonda Horner-Davis

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

EDITORIAL BOARD MEMBERS

• Lessons on Leadership...........................................................................................8

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

BOARD OF DIRECTORS EXECUTIVE DIRECTOR Penny Shelton PRESIDENT Beth Mills PRESIDENT-ELECT Matthew Kelm PAST PRESIDENT Dave Phillips TREASURER Ryan Mills SECRETARY Paige Brown Kevin Rhash, Chair, SPF Tyler Vest, Chair, NPF Anna Armstrong, Chair, Community Angela Livingood, Chair, Health-System Janine Bailey, Chair, Chronic Care Irene Ulrich, Chair, Ambulatory Ouita Gatton, At-Large Vinay Patel, At-Large Riley Bowers, At-Large North Carolina Pharmacist (ISSN 0528-1725) is the official journal of the North Carolina Association of Pharmacists.

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

• From the President.............................................................................................6

• Community Pharmacy Scholarship......................................................................11

• New Drug Monograph.......................................................................................14 • Audit Alert..........................................................................................................20

• Election Reminder...............................................................................................22 • Harm Reduction Series........................................................................................24

• Leadership and Financial Buzz......................................................................25

• Student Pharmacist Conference............................................................................27 • Pharmacy Technician Conference.......................................................................29

• I Choose Membership...........................................................................................30

Click Here To Stay Connected North Carolina Pharmacist is supported in part by: • EPIC Pharmacies Inc ............................................................................7 • The Partnership for SAFEMEDICINES ...........................................10 • Pharmacy Quality Commitment ........................................................13 • Alliance for Patient Medication Safety (APMS)................................18 • NCAP Career Center ..........................................................................19 • Pharmacy Audit Assistance Service (PAAS)......................................20 • Pharmacy Technician Certification Board (PTCB) .........................21 • Pharmacists Mutual Companies ........................................................23 • VUCA Health .......................................................................................26 • Your Community Health Plan ............................................................28 CORRECTIONS AND ADVERTISING For rates and deadline information, please contact Rhonda Horner-Davis at rhonda@ncpharmacists.org

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

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

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

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

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

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

North Carolina Pharmacist is the Official Journal of the North Carolina Association of Pharmacists Located at: 1101 Slater Road, Suite 110 Durham, NC 27703 Phone: (984) 439-1646 Fax: (984) 439-1649 www.ncpharmacists.org Page 3

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

The Architecture of Success

It is a beautiful September day as I write this column. Earlier this morning, I wrote a letter to Governor Cooper. This was the second letter, in as many months, asking for his support to sign one of our bills into law. Since March of this year, we have succeeded in getting the General Assembly to pass three of the five pieces of legislation we had introduced in this session.

The new laws have multiple provisions, including new authorities for pharmacists and technicians and improved access to care and protections for patients. Our legislative wins had me thinking about our journey and the concept of ‘architecture of success’.

Regarding our legislative work, prior to 2019, NCAP had not had much of a presence on Jones Street for many years. This absence of activity put us at a disadvantage and made us an underdog, for sure. How could NCAP prevail? First, I think it was important to embrace our underdog status and recognize that any win would be a great feat, given the strength of our opposition, and that NCAP would have to

work hard to develop allies on both sides of the aisle, as well as in both the House and Senate. We also would need a strong advocacy plan, with issues that pharmacy found important and would resonate with others. Of course, just as important would be the need for patience, hard work, and persistence!

However, for our Association, a true ‘architecture of success’ would need to incorporate a blueprint far beyond just our advocacy work. For those of you that have been members for at least five years, you may remember we implemented a ‘blueprint’ for how our Association would make decisions and on what we would concentrate our energy and resources. This included maintaining a fluid or dynamic strategic plan, and our blueprint for paving success introduced three key operational tenets. I have not referred to these tenets in a while, but this column is the perfect opportunity to share them with our members again.

Essentially, everything that NCAP does must further our mission and bring us closer to our vision, as well as meet one or more of the following: • Build awareness about the Association and the role of pharmacists/ technicians.

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• Create meaningful value for our members.

• Generate a voice for the profession.

NCAP is working hard to proactively create our future versus reacting and adapting to the blows we are dealt as a profession. I know we will still need to be nimble, and there will always be a need to adapt; but, there is some bite in this underdog now.

We have a stick-to-itiveness for which we hope our members are proud.

Malcolm Gladwell is credited with saying, “being an underdog changes people in ways that we often fail to appreciate. It ... creates opportunities … and permits things that might otherwise have seemed unthinkable.” For some time, people had lost faith in NCAP, and they questioned our ability to make a difference.

Hopefully, it is now evident that there is both scrappiness and sophistication to NCAP! We have a plan, and we are doggedly determined to get results! We are delivering on our promises!

We are generating value for our members, getting wins for our profession, and creating new resources and opportunities along the way.

We have three new, specialized conferences planned for this fall, one for student pharmacists, one for pharmacy technicians, and an anti-infective conference. Also new and exciting is a formal partnership with CPESN-NC. Closer alignment of our organizations will strengthen our ability to execute contracts with payers in our state. This October, our Health System Practice Academy will be writing a strategic plan to better position NCAP for meeting the needs of our hospital pharmacist members.

Currently, the Association is coordinating a number of volunteer teams. They will be working on drafting standing orders, and creating education and training to provide nicotine replace-

ment therapies, birth control, HIV post-exposure prophylaxis, prenatal vitamins, Glucagon, and the administration of long-acting injectable medications.

year when our New Practitioner Forum (NPF) launched “Leadership Buzz,” a leadership professional development program. It was incredibly successful, so this year, the NPF is adding a financial series, “Financial Buzz,” for early-career pharmacists, too. Financial Buzz kicks off this month, and Leadership Buzz will begin in October. If you graduated from pharmacy school in 2015 or after, please sign up and take advantage of both of these programs.

In this issue, you will find information on two new initiatives.

The first is the official launch and opening of the application process for the Fellow Practitioner designation with our Association, the FNCAP credential. This is an opportunity for NCAP members (pharmacists and technicians) who have excelled in practice and given back to the Association to be formally recognized and credentialed as a Fellow within the North Carolina Association of Pharmacists.

NCAP is keeping the big picture in mind, and that is you, our members! We have a sound blueprint, an ‘architecture of success,’ which is definitely delivering results! I hope you enjoy this issue.

The second initiative began last

Pharmacy Proud, Penny

FELLOW PRACTITIONER RECOGNITION PROGRAM In an effort to promote sustain and foster the advancement of pharmacy practice across the state NCAP is providing a Fellow Practitioner Recognition Program for Pharmacist and Pharmacy Technician members in all areas of practice settings ,

,

,

.

Awarding NCAP Fellow status FNCAP is one means by which NCAP fosters and rewards demonstrated excellence in the practice of pharmacy (

Check the Professional Development section of our website for more information and to learn how to apply!

)

.

Now accepting applications!

Priority deadline: March 18, 2022

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•From the President• Dr. Beth Mills, PharmD, CPP, BCACP, CDE

Close The Gap!

Membership is often seen as a “vital sign” or “health status” of a professional association. A healthy organization is one with increasing membership enrollments and a strong retention rate. NCAP’s mission is to serve its members, but without members, it would become sick or even cease to exist. It isn’t merely about collecting dues and paying bills; it’s about members working together to achieve a shared vision and overcoming challenges facing our profession. It’s about members being actively engaged and invested in professional advancement strategies to close the gap between where pharmacy is today and its true potential.

Recruiting and retaining members has become more difficult over time, and the Covid-19 pandemic has made it even more difficult. Many professional organizations are reporting no growth or declining membership.

This is largely driven by changes in socio-economic trends such as financial stability, demographic shifts, and changing technology.

Becoming a member of an organization is often a decision of

perceived value and is largely measured by the benefits and services offered. Visit the NCAP website, ncpharmacist.org, to appreciate all NCAP has to offer.

NCAP has built a library of toolkits and workshops to enhance members’ skills and knowledge.

Visit our advocacy page to see recent success with the approval of bills aimed at advancing pharmacy scope of practice, patient safety and outcomes, and regulation of PBMs in our state. Students and new graduates may be facing uncertain financial situations as they transition into the workforce. NCAP offers multiple levels of membership dues starting with $10 annually for students, reduced rates for 1st and 2nd-year pharmacists, residents, and fellows, and $195 annually for full active membership. NCAP has recently launched several membership campaigns offering reduced membership rates. Be on the lookout and share them with nonmembers, so they do not miss out on this fantastic opportunity.

Appealing to a younger audience has many challenges. This generation is looking for ways to get involved that are more informal and require less time commitment. They prefer instant communication for quick Page 6

decision-making. NCAP has very active Student Pharmacist and New Practitioner Forums. These groups have had a very busy and exciting year with multiple virtual activities aimed at building skills in leadership and advocacy.

Students and residents have been involved in social media, toolkit and workshop development, and many other exciting activities.

NCAP values its student members and has planned a student conference which will be held on October 9th and will include the residency showcase for interested students to learn about residency programs.

Rapidly changing technology has given us new methods for information delivery.

In-person gatherings and meetings can now be supplemented or replaced with virtual learning and networking platforms. Due to the pandemic, in-person gatherings were restricted. In response, NCAP has acquired a new association management system and website with better accessibility and functionality. In addition, we have a new learning management system that has enabled us to offer virtual continuing education webinars, workshops, and conferences.

When I am asked why I joined NCAP, I say it is because I am a pharmacist, and it is my duty to my profession. I joined NCAP because it is the one pharmacy organization in North Carolina that represents me as a pharmacist. It does not matter that I am an ambulatory care pharmacist or work in a community pharmacy; NCAP represents me. When I worked in hospital pharmacy as a clinical pharmacist or staff pharmacist, NCAP represented me too. If I were to ask you why you became a member of NCAP, what would you say? I challenge you to think about the value NCAP brings to you professionally and personally. Then share this with your pharmacy colleagues, coworkers, friends, students, residents, and technicians. Encourage them to

join NCAP and realize the benefits of an organization committed to advancing, uniting, and serving the pharmacy profession.

Lastly, I encourage you to help close the gap between where pharmacy is today and its true potential. You can do this by serving in a leadership position on an Academy, Forum, Executive Committee, or Board of Directors. Please reach out to Angie Broughton at angie@ncpharmacist.org. We need dedicated, passionate pharmacists just like you to help lead our association.

Beth Mills

NCAP President

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Lessons on Leadership By: Dr. D. Byron May, PharmD

Note from the Editor: The following is a segment of a presentation given by Dr. D. Byron May, the 2021 recipient of the Milton W. Skolaut Leadership Award. This annual award is given to a past resident of the Duke University Hospital Pharmacy Residency Program as recognition for outstanding leadership and contributions to the profession of pharmacy. This presentation, “Lessons on Leadership,” was given to the Pharmacy Residency Class of 2021 and the many practitioners in attendance. Whether you are a newcomer to the profession or well-seasoned, I believe the thoughts shared by Dr. May are valuable and relevant to us all!

“I will share five lessons I have learned over my 30 plus year career in pharmacy practice and academia. Lessons I believe that have enhanced my leadership skills.” Dr. D. Byron May

Lesson 1: Relationships Previously I mentioned the importance of relationships, and I am reminded about the often-heard phrase ‘pharmacy is a small profession.’ Although our profession has significantly

grown since I graduated, it is still very accurate. It is essential to cherish, foster, and maintain your friendships and relationships because there may be a time when the network you started in pharmacy school, early in your career, or even later in your career will pay off!

I often love repeated phrases such as “it’s not what you know but WHO you know,” which I can tell you is very true! I cannot stress enough the importance of relationships and networking.

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Lesson 2: Reputation As a resident of Duke University Medical Center, you are graduating from a place with a tremendous reputation built and expanded upon by the people past and present, those in this room and watching via live stream. A reputation propagated by the current Duke pharmacy leadership and one you have been given the honor of maintaining and spreading.

You carry with you more than the respect our profession has

bestowed upon you but the additional honor of being a “Duke” pharmacist! So, my advice is to use the professional “capital” you have earned and grow your reputation with respect, trust, integrity, and honesty, not only as a professional but as a person. I can tell you from personal experience having those attributes as your reputation, whether it is among your friends, colleagues, or patients, is invaluable. Should you ever have the desire or privilege of being a leader, be mindful that these characteristics must be earned and cannot be granted a leadership position or job title.

Lesson 3: Development

I suspect many of you, sooner or later, will move into a position of leadership. My advice, no matter how much you think your training may have prepared you to ‘lead,’ your personal and professional growth must have time to develop first. (Refer back to lesson 1.)

want to demonstrate, but those who possess the negative characteristics that you would never hope to emulate.

I believe you can learn as much or more from ‘negative’ role models as you can from positive ones.

That is why of the many books I have read on leadership, success, and positive thinking, it is the books I have on ‘failing’ that may have been even more valuable to me.

Books such as “The Top Ten Mistakes Leaders Make” by Hans Finzel or “The Power of Failure”

by Fran Tarkenton, or “Failing Forward” by John Maxwell, to name a few.

Lesson 5: Your Team

The real key(s) to being successful lie in who you surround yourself with, what you ask (allow) them to do, and how you encourage thinking and ideas that are different from yours that force you to challenge your assumptions. To do this, you must Understand that your growth as a person and professional is only be confident in your strengths and weaknesses and not feel beginning. None of this is to say that any of you won’t be ready for threatened or intimidated by those around you. Be patient as the next challenge; know that so much will change when you make you begin your career, soak up the knowledge and wisdom of that decision. everyone you work with, and chart your path for success using a compass created by the posiLesson 4: Influences tive AND negative ‘leaders’ you Besides reputation, as previously encounter. mentioned, another factor for In my mind, admired, effective, success is the mentors, leaders, and successful leaders have these colleagues, and friends with things in common. They have whom you interact over your earned the titles/position they career. Not just those who exhibit occupy through accomplishment the positive skills and traits you and achievement (merit). Do not Page 9

accept a position of responsibility just because someone offers it to you; do so because you have the humility and personal insight to know if YOU are ready to accept that responsibility. Are you aware of your strengths and weaknesses, and are you confident enough to surround yourself with people who may challenge you or even be more qualified than you?

Do not be threatened by those people, but instead, embrace and welcome them (to a point anyway). In my humble opinion, that will earn you the trust and respect that is inherent in any “office or position” you hold.

I could speak longer on what I have learned about leadership, but fortunately for you, there are many others with far greater wisdom than me. I do, however, want to leave you with a couple of final pearls of wisdom.

For those privileged to have known Dr. Gary Dunham, he used to say, “nobody cares how much you know until they know how much you care.” This precious yet straightforward truth is worth repeating and remembering.

And finally, a philosophy that I think I heard from a pharmacy school classmate but was perpetuated and exemplified by COL Bill Pickard is called the “6 P’s” – Proper Prior Planning Prevents Poor Performance!

Thank you for indulging me and for the honor of bestowing upon me the Milton Skolaut Leadership Award! Best of luck to you all!

Dr. D. Byron May is a Professor of Pharmacy at Campbell University College of Pharmacy & Health Sciences. mayb@campbell.edu.

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Community Pharmacy Scholarship Accepting Applications for 2022 Scholarship October 1, 2021 to December 1, 2021.

The Pharmacists Mutual Community Pharmacy tion from a faculty member or advisor, and an essay Scholarship is a scholarship program sponsored by describing their interest in practicing in an indepenPharmacists Mutual. dent or small chain community setting, or in an underserved community. Their essay should describe Recipients selected for the Pharmacists Mutu- steps they have taken to prepare themselves for al Community Pharmacy Scholarship will each be their chosen practice setting. The application winawarded $3,000. Up to $60,000 in scholarships may dow will open in October 2021. be awarded annually. This program acknowledges students interested in serving in an independent or 2021 Scholarship Awards small chain community pharmacy, or in an underserved geographic area. Student pharmacists must Congratulations to the 2021 Pharmacists Mutual complete the scholarship application and essay by Community Pharmacy Scholarship recipients for the scholarship deadline to be considered for the the 2021 – 2022 scholarship awards.

Pharmacists Mutual Community Scholarship.

Each student has received a $2,500 Scholarship: Eligibility Requirements: Brianna M. O’Gary | North Dakota State University

To be eligible to apply for the 2022-2023 PharmaCatherine M. Hayes | University of Illinois at Chicago cists Mutual Community Pharmacy Scholarship, stuColin Collery | University of Illinois at Chicago dents must meet the following criteria: • Be a current P2 or P3 pharmacy student that will be a P3 or P4 pharmacy student in the 2022-2023 academic year

• Eligible students must plan to practice in one of the following settings:

*an independent or small chain community pharmacy

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Kinsey M. McClure | University of South Carolina Madison Yoakum | Ohio Northern University

*an underserved geographic or cultural com- munity, preferably in an independent or small chain community pharmacy

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Page 13

New Drug Monograph

By Lindsey Benavente, PharmD Dylan King, PharmD Candidate

Lupkynis (voclosporin) Aurinia Pharmaceuticals Inc. By:

Generic Name: Voclosporin

Brand Name: LupkynisTM

Classification: Calcineurin-inhibitor immunosuppressant

Indication: Approved for use in combination with a background immunosuppressive therapy regimen (mycophenolate mofetil and corticosteroids) in the treatment of active lupus nephritis in adults.

Contraindications: Voclosporin is contraindicated in patients concomitantly taking strong CYP3A4 inhibitors such as ketoconazole, itraconazole, and clarithromycin.

US Boxed Warning: Voclosporin increases the risk for developing

serious infections and malignancies (e.g., lymphomas and particularly cancer of the skin) and can lead to hospitalization or death.

The risk appears to be related to the intensity and duration of immunosuppression.

Pharmacology: Voclosporin is a calcineurin inhibitor that inhibits calmodulin activation leading to the prevention of Nuclear Factor of Activated T-Cell Cytoplasmic (NFATc) activation; thereby, inhibiting lymphocyte proliferation, T-cell cytokine production, and the expression of T-cell activation surface antigens.

Pharmacokinetics: The whole blood voclosporin pharmacokinetics increase in a greater than dose-proportional manner over the therapeutic range. With twice daily dosing, voclosporin achieves steady-state after 6 days and the accumulation is approximately 2-fold.

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Absorption Maximal absorption occurs within 1 to 4 hours when administered on an empty stomach. If taken with food, the rate and extent of absorption is reduced by 29% to 53% and 15% to 25% if taken with either low- or high-fat meals, respectively.

Distribution Voclosporin is 97% protein bound and has an apparent volume of distribution of 2,154 L. Distribution of voclosporin between whole blood and plasma is both concentration- and temperature-dependent.

Metabolism Voclosporin is primarily metabolized by CYP3A4 to a metabolite found to be about 8-fold less potent than the parent molecule.

Elimination Primarily excreted through the feces (92.7%), including 5% as unchanged. Voclosporin is excret-

ed minimally in the urine (2.1%), including 0.25% as unchanged.

The mean apparent clearance at steady-state is 63.6 L/h, and mean terminal half-life is approximately 30 hours (24.9 to 36.5 hours).

Clinical Efficacy A randomized, controlled double-blind study conducted by Rovin and colleagues evaluated the efficacy and safety of voclosporin compared to placebo in achieving remission in patients with active lupus nephritis.

Study participants were between 18 to 75 years of age who met at least 4 American College of Rheumatology criteria for lupus and had active Class III, IV, or V lupus nephritis as determined by kidney biopsy within 6 months of screening. Two-hundred sixty-five patients on background therapy (mycophenolate mofetil plus low- to -medium dose corticosteroids) were randomized to receive placebo (low-dose, n = 44; high-dose, n = 44), lowdose voclosporin (23.7 mg twice daily, n = 89), or high-dose voclosporin (39.5 mg twice daily, n = 88). Baseline characteristics were similar among groups, with a majority of participants being Asian/Asian-Indian females with an average baseline eGFR of 99.8 mL/min/1.73 m2. The primary endpoint was complete renal remission (CRR), defined as a decrease in UPCR to < 0.5 mg/mg in 2 consecutives, first morning void urine samples, plus an eGFR > 60 mL/min/1.73 m2 or no decrease in baseline eGFR by > 20% on 2 consecutive occasions, after 24 weeks of therapy. Secondary endpoints assessed the safety, tolerability, and efficacy of voclosporin compared to placebo after 48 weeks of therapy.

After 24 weeks, patients receiving low-dose voclosporin were significantly more likely to reach CRR compared to placebo, as CRR was achieve by 32.6% (OR = 2.03; CI 1.01 – 4.05; p = 0.046) of patients compared to 19.3%. While not significantly higher than placebo, high-dose voclosporin resulted in a greater CRR rate, with CRR achieved by 27.3% of patients (OR = 1.59; 95% CI 0.78 – 3.27; p = 0.204).

After 48 weeks, both low- and high-dose voclosporin resulted in significantly higher CRR, with CRR being achieved by 49.4% (OR = 3.21; 95% CI 1.68 – 6.13); P < 0.001) and 39.8% (OR = 2.01; 95% CI 1.09 – 4.02; p = 0.026) of patients, respectively, as compared to 23.9% in the placebo group. In evaluating the time it took to reach CRR, the median time for low-dose voclosporin was 19.7 weeks and 23.4 weeks for high-dose. Adverse events occurred more commonly in patients who received voclosporin, with any event reported in 92.1% and 96.6% of patients receiving low- and high-dose voclosporin, respectively, as compared to placebo with any adverse event reported in 85.2% of patients.

The most common adverse events reported by all treatment arms were infections and gastrointestinal disorders. Furthermore, in evaluating renal function, a change in eGFR greater than 10% was observed in 50.6% of patients receiving low-dose voclosporin and 62.5% of patients receiving high-dose voclosporin as compared to 17% of patients who received placebo. Ultimately, this study revealed low-dose voclosporin in combination with background therapy is superior to placebo in combination with Page 15

background therapy in achieving CRR after both 24 and 48 weeks.

Furthermore, while voclosporin was generally well tolerated, more patients receiving voclosporin experienced greater than a 10% change in eGFR, though the difference was not found to be statistically significant.

A phase 3 study has been conducted by Arriens and colleagues and the results presented at the EULAR and ERA-EDTA annual meetings in 2020. This trial was a multicenter, randomized, double blind, placebo-controlled study comparing voclosporin plus background therapy to placebo plus background therapy, defined as IV methylprednisolone once daily on days 1 and 2 (0.5 g/day in patients > 45 kg and 0.25 g/day for patients < 45 kg).

All patients then began a rapid taper of oral prednisone on day 3 beginning at 20 - 25 mg per day, decreased over time to 2.5 mg per day at week 16. In this study, 357 patients were randomized in a 1:1 fashion to receive voclosporin 23.7 mg twice daily or placebo. Patients included in the study had to have had a biopsy-proven active Class III or IV lupus nephritis and a urine protein to creatinine ratio > 1.5 mg/mg or Class V lupus nephritis with a UPCR > 2 mg/mg. The study was composed primarily by white females and the average eGFR on entry was 91 mL/min/1.73 m2. The primary endpoint was the proportion of patients who achieved CRR (following the same definition as the previous study) after 52 weeks of therapy defined as a composite of UPCR of 0.5 mg/mg or less, eGFR of 60 mL/min or more or no confirmed eGFR decrease > 20% from baseline, no rescue medication

administration, and no more than 10 mg prednisone equivalent per day for 3 or more consecutive days or 7 or more days during weeks 44 - 52 before the primary endpoint assessment. Secondary hierarchical endpoints were time to UPCR of 0.5 mg/mg or less, partial renal response (≥50% reduction from baseline UPCR) at weeks 24 and 52, time to 50% reduction in UPCR from baseline, and complete renal response at week 24 in order. One-hundred seventy-nine patients were randomized to receive voclosporin and 178 were randomized to placebo.

CRR at week 52 occurred in 40.8% of patients receiving voclosporin compared to 22.5% of those receiving placebo (OR = 2.7; 95 CI 1.6-4.3; p < 0.001).

In evaluating disease-related eGFR-associated adverse events after 52 weeks, this was experienced by 82.1% of patients receiving voclosporin compared to 75.8% of patients receiving placebo (OR = 1.5; 95% CI 0.82.5). While more adverse events were associated with treatment, the difference was not statistically significant when compared to placebo. When evaluating secondary endpoints, 116 (65%) patients in the voclosporin group achieved an UPCR of 0.5 mg/mg or less during the study than in the placebo group (78 [44%]) and the time to reach this threshold was significantly shorter for the voclosporin group. A 50% reduction in UPCR from baseline during the study was achieved by 173 (97%) patients treated with voclosporin compared with 135 (76%) patients receiving placebo. The median time to achieve a 50% reduction in UPCR was significantly shorter for the voclo-

sporin group than in the placebo group. Overall, for both primary and secondary endpoints the results seem to favor voclosporin over placebo and ultimately this study resulted in outcomes similar to the study previously discussed in that a higher proportion of patients in the voclosporin arm achieved CRR and reduced UPCR when compared to placebo.

Drug Interactions: CYP3A4 Inhibitors: Voclosporin is extensively metabolized by CYP3A4; therefore, co-administration with strong-to-moderate CYP3A4 inhibitors increases voclosporin concentrations. Co-administration with ketoconazole, itraconazole, clarithromycin, and other strong CYP3A4 inhibitors is contraindicated. Co-administration with moderate CYP3A4 inhibitors such as verapamil, fluconazole, and diltiazem are not contraindicated; however, the dose of voclosporin should be reduced. Voclosporin should not be taken with any food or drink containing grapefruit.

CYP3A4 Inducers: Voclosporin is extensively metabolized by CYP3A4; therefore, co-administration with strong or moderate CYP3A4 inducers can decrease voclosporin concentrations and its efficacy. The manufacturer suggests avoiding co-administration with strong-to-moderate CYP3A4 inducers.

P-gp Substrates: Voclosporin is a P-gp inhibitor, therefore when given concurrently with a P-gp substrate, voclosporin may increase the concentration and risk of adverse reactions associated with these substrates.

OATP1B1 Substrates: In vitro, Page 16

voclosporin has been shown to be an OATP1B1 inhibitor. These interactions have not been studied clinically; however, it is important to monitor for possible adverse reactions and increased concentrations of OATP1B1 substrates when taken with voclosporin.

Immunizations: Voclosporin is an immunosuppressant and live attenuated vaccines should be avoided.

Adverse Effects: The most common adverse reactions to voclosporin are reduction in mean glomerular filtration rate (26%), hypertension (19%), diarrhea (19%), headache (15%), anemia (12%), cough (11%) and urinary tract infection (10%). Less common reactions include alopecia, hypertrichosis, gastrointestinal issues, fatigue, tremor, acute kidney injury, and renal insufficiency (1-10%). Prolonged QT intervals have been documented and appear to be dose-dependent; however, the frequency in which this adverse reaction occurs is not defined. Other reactions with unknown frequency include hyperkalemia, azotemia, hematologic/oncologic issues, infections, and CNS disturbances.

Pregnancy and Lactation: While there is limited data to establish drug-related risks associated with voclosporin and pregnancy, it is recommended voclosporin be avoided in pregnant women due to its alcohol content (21.6 mg of dehydrated ethanol per capsule for a total of 129.4 mg/day). Animal studies have found that voclosporin is embryocidal and fetocidal in rats and rabbits at doses 15- and 1-times the maximum recom-

mended human dose (MRHD) of 23.7 mg twice daily. Furthermore, animal studies have linked voclosporin doses at 0.1 to 0.3-times the MRHD in rabbits to reduced placental and fetal body weight.

mg twice daily. If at follow up visits eGFR is < 60 mL/min/1.73m2 and has decreased by 20-30% from baseline, the dose should be reduced by 7.9 mg twice a day.

If the eGFR is still reduced from baseline by > 20% in two weeks There is no available data from after the initial dose reduction, humans regarding the presence reduce the dose again by 7.9 mg of voclosporin in breastmilk or twice a day. If eGFR is < 60 mL/ its effects on lactation. In animal min/1.73m2 and reduced from models, voclosporin was detected baseline by > 30%, discontinue in the milk of lactating rats, indiand reassess eGFR in two weeks.

Voclosporin may be re-initiatcating it would likely be present in human milk as well. The use of ed at 7.9 mg twice daily if eGFR voclosporin is not recommended returns to > 80% of baseline, in lactating women, and breastand the dose can continue to be feeding should be avoided for at increased by 7.9 mg twice a day least 7 days after the last dose of for each eGFR measurement > voclosporin.

80% of baseline, not to exceed the initial starting dose.

Dosing: The recommended starting dose for voclosporin Storage: Store in the original in patients with normal renal packaging at room temperature function is 23.7 mg (3 capsules) (20oC to 25oC); may be stored twice a day taken on an empty briefly at 15oC to 30oC. stomach. It is important to stay as consistent as possible with at Dosages and Cost: Voclosporin least 8-hours between doses. If a is available as 7.9 mg capsules dose has been missed, the patient contained within a wallet consistshould be instructed to take the ing of four individual 3 x 5 blister dose as soon as possible within strips (60 capsules) or carton 4-hours of the missed dose. If containing three wallets (180 it has been > 4 hours, omit the capsules). Cost has not yet been missed dose and continue taking established. at scheduled time. Baseline eGFR must be established prior to Summary/Use in clinical practreatment initiation and should tice be assessed every two weeks for Voclosporin in addition to backthe first month and every four ground immunosuppressive weeks thereafter. If eGFR is < 45 therapy (mycophenolate mofetil mL/min/1.73m2 at baseline, voc- plus corticosteroids) is a viable losporin is not recommended as option for treating patients with it has not been studied in these lupus nephritis. Lupus nephritis is a serious condition that withpatients. However, if used in paout appropriate treatment can tients with severe renal impairment, the recommended starting lead to permanent and irreversdose is 15.8 mg twice daily. In ible damage to the kidneys. The standard of therapy is currently patients with mild to moderate high-dose corticosteroids plus hepatic impairment (Child-Pugh either mycophenolate mofetil or A or Child-Pugh B), the recommended starting dose is also 15.8 cyclophosphamide. UnfortunatePage 17

ly, research has shown that after 6 to 12 months of therapy, only 10 to 40% of patients achieve CRR, indicating the need for a more efficient treatment regimen. Voclosporin is a next-generation calcineurin inhibitor similar to cyclosporine; however, it is more potent and is metabolized quicker, eliminating the need for drug level monitoring.

When compared to the current standard of treatment for lupus nephritis, treatment with voclosporin resulted in a higher proportion of patients reaching CRR. While an effective treatment, the use of voclosporin is associated with more adverse effects such as reduced eGFR, hypertension, and headache when compared to placebo. Prior to the initiation of voclosporin, it is important for providers to evaluate the patient’s renal function and their list of current medications. Voclosporin should not be taken concomitantly with potent CYP3A4 inhibitors, as these will increase voclosporin concentrations and the risk for adverse effects. Furthermore, it is important to counsel patients on the importance of staying consistent and separating doses by at least 8 hours and to take on an empty stomach to ensure absorption. The manufacturer suggests monitoring blood pressure every two weeks for the first month after initiating voclosporin, and as clinically indicated thereafter. If the patient experiences readings >165/105 mmHg or presents with hypertensive emergency, voclosporin should be discontinued and antihypertensive therapy initiated.

Voclosporin is relatively new and the most recent findings from Arriens and colleagues have yet

to be fully published. While the safety and efficacy of voclosporin has been documented through recent studies, long-term outcomes have yet to be reported. Furthermore, these trials reveal voclosporin is superior only to placebo and background immunosuppressive therapy; therefore, future studies are necessary to determine its efficacy when compared to other calcineurin inhibitors and its usability in the treatment of active lupus nephritis.

Authors: Dr. Lindsey Benavent is a PGY-1 Resident at Novant Health New Hanover Regional Medical Center and Dylan King is a P-4 PharmD Candidate at Campbell University College of Pharmacy, dmking0617@email. campbell.edu.

Bibliography

1. Lupkynis [package insert]. Rockville, MD: Aurinia Pharma US, Inc; 2021.

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

Accessed February 16, 2021.

3. Rovin BH, Solomons N, Pendergraft WF 3rd, et al. A randomized, controlled double-blind study comparing the efficacy and safety of dose-ranging voclosporin with placebo in achieving remission in patients with active lupus nephritis. Kidney Int. 2019;95(1):219-231. doi:10.1016/j.kint.2018.08.025 4. Arriens C, Polyakova S, Adzerikho I, et al.

OP0277 AURORA phase 3 study demonstrates voclosporin statistical superiority over standard of care in lupus nephritis. Annals of the Rheumatic Diseases 2020;79:172-173. Abstract.

5. Rovin BH, Teng YK, Ginzler EM, et al.

Efficacy and safety of voclosporin versus placebo for LUPUS nephritis (AURORA 1): A double-blind, randomized, multicenter, placebo-controlled, Phase 3 trial.

The Lancet. 2021;397(10289):20702080. doi:10.1016/s01406736(21)00578-x.

Page 18

Page 19

Audit Alert: Are You Billing the Correct NDC?

PAAS Tips:

PAAS National® is once again

seeing recoupment on audits when a pharmacy bills the wrong NDC for the product dispensed.

Unit-of-use packages like test strips, inhalers, and topical medications tend to have the most errors and are easily targeted on audits. If the quantity billed does not match the product size indicated by the NDC, some PBMs will charge back the entire claim!

This can be true whether billing 45 g on a topical that come as a 50 g tube or billing the NDC for 50-count test strips and dispensing the 100-count package size (potentially leading to invoice audit errors or additional cost to plan). PBMs go after the latter when the cost of dispensing the larger package size is less than the cost for two smaller size packages. The pharmacy is expected to dispense the package size that costs less for the plan.

attach it to the prescription

• Implement barcode scanner • If you are out of stock on the technology for product verifica- quantity prescribed but can order it from your wholesaler, do so if tion to prevent misfills the patient can wait for it to come • Dispense the correct package in size, closest to what the prescriber indicated, without going over If the patient cannot wait due to a true clinical need, document this the written quantity on the hard copy • For topical medications, ensure the quantity billed matches tube • Consider flagging shelves containing high risk items for packsize dispensed age size errors to remind staff to For example, do not submit the doublecheck NDC for a 28 g tube but bill for 30 g PAAS National® is committed to Often, the last 2 digits of the NDC serving community pharmacies and helping keep hard-earned match the package size money where it belongs. Contact • Contact the prescriber to con- us today at (608) 873-1342 or firm changing the quantity to the info@paasnational.com to see accurate manufacturer package why membership might be right size, especially if that package for you. size is larger than originally prescribed

By Trenton Thiede, PharmD, • If you need to dispense two MBA, President at PAAS Nasmaller package sizes because tional®, expert third party authe larger package size is backor- dit assistance and FWA/HIPAA dered (e.g., dispensing two 15 g compliance. tubes instead of a 30 g tube), document this and print proof from your wholesaler that the larger ©2021 PAAS National® LLC All package size was unavailable and Rights Reserved Page 20

Page 21

NCAP Board of Directors and Practice Academy Elections Reminder!

Ambulatory Care

st Time is Running Out to Submit Your Name Chair-elect (1 year is served as Chair-elect; nd rd for NCAP Board of Directors and Practice 2 year as Chair; 3 year as Past Chair). Also, 1 At-large position will need to be filled.

Academy Elections

Serving on one of the practice academy leadership teams or the Board of Directors is an excellent way to become more involved in important decisions being made for your academy and our association (NCAP). This is your chance to serve and have your voice heard. The commitment to serve on the leadership teams is three years. If you are elected to serve, your term will begin January 2022. If you are interested, please email Angie Broughton, angie@ncpharmacists.org.

Please include your name, a headshot, a brief bio and your CV by September 24, 2021. The following positions are open.

NCAP Board of Directors

Chronic Care

Chair-elect (1st year is served as Chair-elect; 2nd year as Chair; 3rd year as Past Chair). Also, 3 At-large positions will need to be filled.

Community Care

Chair-elect (1st year is served as Chair-elect; 2nd year as Chair; 3rd year as Past Chair). Also, 2 At-large positions will need to be filled.

Health-Systems

Chair-elect (1st year is served as Chair-elect; 2nd year as Chair; 3rd year as Past Chair). Also, 1 At-large position will need to be filled.

President-elect (1st year is served as Presi- American Society of Health-System Pharmacists (ASHP)Delegates dent-elect; 2nd year as President; 3rd year as Immediate Past President). Also, 1 At-large There will be 2 ASHP positions available. position will need to be filled.

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NC Association of Pharmacists

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This program is supported by the Health Resources and Services Administration (HRSA) of the U.S. Department of Health and Human Services (HHS) as part of an award totaling $1,000,000 with 0 percentage financed with non-governmental sources. The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement, by HRSA, HHS or the U.S. Government.

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It’s Back!

NCAP and the New Practitioner Forum Present Leadership and Financial Buzz!

The NCAP New Practitioner Forum (NPF) is hosting Leadership Buzz with a new addition; we’re adding Financial Buzz! Financial Buzz addresses the unique financial needs of individuals in the early years of their career. Sessions will be facilitated by leaders across the state and members of the NPF Leadership Team.

Residents, fellows and recent graduates (2015-2021) are invited to join the group for personal and leadership development through reading and discussing diverse books and/or attending the virtual presentation of the Early Career Financial Series. It is requested that Leadership Buzz participants commit to at least 4 out of the 5 book sessions. If you have questions or would like to join the group, please, contact Tyler Vest, NPF Chair, at Tyler.Vest@duke.edu.. Sessions will begin in September. The first Tyler.Vest@duke.edu Financial Buzz session will be September 29th.

For more details and to register, click here here..

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

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

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The North Carolina Association of Pharmacists

Student Pharmacist Conference October 9th 9:00am-3:00pm For The Health & Safety Of Our Participants This Is An All Virtual Event Cost is $25.00 Click here for more details and to register

Featuring: Residency Showcase Pharmacist and Student-led discussions Cheer on your school champions in Pharmacy Jeopardy!

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Join now and save!

Active Pharmacists join now for only $100 Use discount code Journal21 The Value of Membership When you join the Association, your membership dues are put to work immediately supporting our noble profession. NCAP is the essential and sole organization representing and fostering the advancement of pharmacy in North Carolina. Your membership helps to build awareness, create value, and generate a voice for pharmacists, pharmacy technicians and student pharmacists. While you are taking care of your patients and practices, the Association’s role is to take care of you, by protecting and advancing our profession. Every dollar of your membership dues goes to support: the development of resources and educational programming; the work of our Board, practice academies, forums, and special interest groups; our advocacy agenda; practice advancement initiatives; committees and general operations.

Membership Benefits

“accept the lifelong obligation to improve (your) professional Legislative and Regulatory Moni- knowledge and competence”.

NCAP provides diverse LIVE and toring and Representation ON-DEMAND continuing educaWhile you are hard at work tion programs throughout the taking care of your patients, practices, and businesses, NCAP year. We provide flexibility to is serving to represent your voice your learning needs, and enable on legislative, regulatory and oth- you, to not only enhance your er policy-related issues which im- knowledge and skills, but to also meet your annual license renewal pact the profession. NCAP is the requirements. We also provide a sole organization that provides number of certificate programs a collective voice for pharmacy.

NCAP works with a lobbyist to designed to provide in depth skill enhancement. Our professional carry out our advocacy agenda. development programs are open to pharmacists, pharmacy techProfessional Development nicians and student pharmacists.

Many of our live and on-demand When a pharmacist takes the programs are free to members, Oath of a Pharmacist at the time of graduation, you vow to and for those that do require Page 30

payment, the price is discounted for members.

Event Discounts

NCAP host an annual convention each year that includes continuing education, networking, roundtables, scientific posters and residency showcase. The annual convention is relevant to all areas of practice. Beginning in 2021, the annual convention will be held in the June/July timeframe. NCAP hosts a Health-System Leaders’ Summit, twice annually, to bring together leaders from our state’s hospitals. Likewise, the Association facilitates town hall style meetings for our Independent Pharmacy Network.

NCAP also hosts focused workshops to help pharmacists and technicians develop specific skills. Members receive significant discounts off registration for NCAP hosted events.

Individual Credit for CME-Accredited Continuing Education

NCAP will co-accredit continuing medical education programs that pharmacists attend. Individuals must submit a form, along with requested documents, in order for NCAP to review, and make a decision on issuing an NC-CE number that can be used for renewal of your NC pharmacist license. This service is FREE for NCAP members and $20/credit hour for non-members.

Practice Tools and Resources

NCAP provides a number of innovative and helpful practice tools and resources for our members.

Examples of available resources include, a COVID-19 Testing Toolkit, an Immunization Toolkit, and an Establishing Clinical Services Toolkit. Our toolkits are designed to provide the nuts and bolts of what is needed to carry out a specific clinical-related need in your practice. Other types of resources available include grant participation opportunities for our members. NCAP grants are related to cutting-edge practice. Our members are the first to be provided with opportunities to participate.

Virtual Networking Communities

NCAP supports a variety of online groups, to help support the special interest of our members.

As examples, we have an online community for new members, one for Independent Pharmacy pharmacists and technicians, student pharmacists, new practitioners and others. Our association management system has the ability to provide an online community for any special interest group to help facilitate the networking needs of our members.

Keeping You Informed

Staying current with what is happening in our profession is one of the hardest things to do.

NCAP keeps members informed through a number of different types of media. Members receive access to two monthly newsletters: 1) general association and industry-related news (E-news), and 2) our Legislative & Policy Update. In addition, members receive access to our quarterly journal. NCAP also helps keep members informed through online posts and emailed ‘alerts’ and ‘calls to action’.

Practice Academies

NCAP has four practice academies for members to choose from: Ambulatory Care, Chronic Care, Community Care and Health-System. The academies are excellent for networking with colleagues who do work similar to you. Members for each academy elect their leadership team members. The chairperson for each academy serves on the Board of Directors, this helps ensure that your voice and practice perspective is represented in the Page 31

governance of our Association.

As a part of your regular NCAP membership dues, pharmacists, pharmacy technicians and student pharmacists can select to be a member of one or more practice academies.

New Practitioner Opportunities

Members in the first seven years of their career as a pharmacist are automatically included in our New Practitioner Forum (NPF).

NPF is a great way to meet individuals, just like you, who are starting out in their pharmacy career. NPF sponsors a number of emerging leadership opportunities for NPF members and residents, as well as networking events to facilitate camaraderie among the newest generation of pharmacists, including our annual Residency Conference.

Becoming active in NPF provides you with an opportunity to participate in activities specifically designed for new practitioners.

It has been our experience that individuals who join after graduation and are involved in our NPF, many times these are the same individuals who go on to help lead our practice academies and other Association leadership roles.

Career Center

Located on our website. Members are invited to create free “job seeker” accounts, set up automated job alerts, and post resumes. Employers can post positions and feel confident in attracting the most qualified candidate pool.

Student Loans and Loan Consolidation Services Pharmacy school is an expensive investment, and many new graduates emerge with considerable student loan debt. NCAP has partnered with Laurel Road, an industry leader in student loan consolidation, to help our members find solutions to their student loan needs. In addition, NCAP recognizes that 4th year pharmacy students generally have additional unplanned costs associated with their final year in school (egs., your car needs repairs or you need help with graduation-related expenses).

Our NCAP Endowment offers a limited number of small student loans to 4th year student members.

Awards

Each year, NCAP recognizes individual professional excellence during our Annual Convention.

Awards are presented to individuals who have been nominated, selected by the Nominations Committee, and recommended to the Board of Directors for approval.

Discounts on Home, Travel and Entertainment

All members have access to exclusive savings on home-based services and shopping, movie tickets, theme parks, hotels, tours, Broadway and Vegas shows, and much more. In order to receive savings, you must be a member of NCAP and you can register online at Working Advantage.com. You will be prompted to create an account with your

email address and our company promo code NCpharm.

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NCAP has teamed up with Our State magazine to bring our members a discount off the annual subscription rate for the premier food, entertainment and travel magazine for all-things-North-Carolina.

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Go to OurState.com and enter the NCAP promo code.

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Financial Services

The Gidley Group, a financial advisory practice of Ameriprise Financial Services, LLC, provides comprehensive financial planning and investment management services for individuals and families.

The Gidley Group offers members of the North Carolina Association of Pharmacists a complimentary financial assessment for their financial planning needs. Whether you are just starting out in your career, contemplating retirement or somewhere in between, we know our members will find this personal service to be beneficial.

The initial consultation provides an overview of financial planning concepts. You will not receive written analysis and/or recommendations.Investment advisory products and services are made available through Ameriprise Financial Services, LLC, a registered investment adviser.Ameriprise Financial Services, LLC, Member FINRA and SIPC.© 2020 Page 32

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Member Types Active Pharmacist -$195 $100 Resident/Fellow- $50

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