North Carolina Pharmacist Volume 106 Number 4

North Carolina Pharmacist Volume 106 Number 4

Advancing Pharmacy. Improving Health.

Happy Holidays!

Official Journal Of The North Carolina Association Of Pharmacists ncpharmacists.org

Call For Articles

North Carolina Pharmacist (NCP) is now accepting articles for publication consideration.

As a peer-reviewed publication, NCP aims to inform, educate, and inspire pharmacists— from students and residents to seasoned practitioners— as well as pharmacy technicians in all areas of practice. We welcome a wide variety of submissions, including original research, quality improvement initiatives, medication safety, case reports or case series, reviews, clinical pearls, unique business models, technology innovations, and opinion pieces. Articles authored by students, residents, and new practitioners are encouraged, and mentors and preceptors are asked to guide their mentees and students in submitting appropriate written work for publication. The Author Instructions have been updated to clarify formatting requirements, improve guidance on referencing, and streamline the submission process. Key changes include a submission disclosure statement and notices regarding the appropriate use of AI. Authors are encouraged to review the complete instructions before submitting to ensure compliance with the new policies. Don’t miss this opportunity to share your knowledge and contribute to the advancement of pharmacy in North Carolina. For details on formatting and article types, click Guidelines for Authors, and for questions, please contact Tina Thornhill, PharmD, FASCP, FNCAP, Editor, at tina.h.thornhill@gmail.com.

North Carolina Pharmacist is the official journal of the North Carolina Association of Pharmacists Located at: PO Box 58 36 Court Square, SW Graham, NC 27253 Phone: (984) 439-1646 Fax: (984) 439-1649 www.ncpharmacists.org

Official Journal of the North Carolina Association of Pharmacists PO Box 58 36 Court Square, SW Graham, NC 27253 Phone: (984) 439-1646

North Carolina Pharmacist Volume 106 Number 4

www.ncpharmacists.org EDITOR-IN-CHIEF Tina Thornhill LAYOUT/DESIGN Rhonda Horner-Davis EDITORIAL BOARD MEMBERS Anna Armstrong Jamie Brown Lisa Dinkins Jean Douglas Brock Harris Amy Holmes John Kessler Angela Livingood Bill Taylor

BOARD OF DIRECTORS

A Few Things Inside • From the Executive Director..............................................................................4 • From the President.............................................................................................6 • Thyroid Disorder Nuances.....................................................................................8 • Cardiovascular Implicatitions of Semaglutitide Discontitinuatition......................12 • Prevalence of Gastrointestinal Bleeding...............................................................20

EXECUTIVE DIRECTOR Penny Shelton

• Drug Monograph - Blujepa (gepotidacin)..............................................................27

PRESIDENT Tom D’Andrea

• NCAP News........................................................................................................30

PRESIDENT-ELECT Leigh Foushee

• Calling All Community Pharmacies......................................................................33

PAST PRESIDENT Bob Granko TREASURER Ryan Mills SECRETARY Macary Marciniak Talia Carlson, Chair, SPF Tyler Pasour, Chair, NPF Lisa Dinkins, Chair, Community Trent Beach, Chair, Health-System Aparna Krishnamurthy, Chair, Chronic Care Glenn Herrington, Chair, Ambulatory Angela Livingood, At-Large Elizabeth Locklear, At-Large Leslie Barefoot, 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.

• 2025 Academy Year End Summaries.....................................................................36

North Carolina Pharmacist is Supported in Part by: • Pharmacists Mutual Insurance Company .................................................7 • Pharmacy Technician Certification Board (PTCB) ................................11 • NCAP Career Center ..............................................................................19 • Pharmacy Quality Commitment .............................................................26 CORRECTIONS AND ADVERTISING For rates and deadline information, please contact Rhonda Horner-Davis at rhonda@ncpharmacists.org

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•From the Executive Director• Penny S. Shelton, PharmD, FASCP, FNCAP

A Holiday Wish: Cultivating Belonging, Purpose, and Forward Momentum

to be “recognized as the essential organization representing pharAs the holiday season draws near, macy in North Carolina, fostering I find myself reflecting on the the advancement of pharmacy many gifts our profession offers practice to improve the health of the people of North Carolina every the people we serve.” single day. Pharmacists, pharma- We have made tremendous cy technicians, and student phar- strides in becoming essential to macists alike continue to show up our state’s agencies, healthcare with remarkable resilience—de- partners, and policy leaders. But livering compassionate care, navi- our next chapter requires somegating unprecedented challenges, thing deeper and more personal: and serving as accessible, trusted becoming essential in the hearts healthcare professionals in every of the people who make this procorner of our state. fession extraordinary. My wish is

Facing Challenges with Optimism and Resolve We cannot ignore the pressures facing pharmacy—staffing shortages, growing demands, and a healthcare system that is evolving more rapidly than ever. Yet, I remain optimistic. As Helen Keller once wrote, “Optimism is the faith that leads to achievement. Nothing can be done without hope and confidence.”

Our hope lies in the daily contributions of pharmacy professionals who consistently go above and This season always reminds me of that every pharmacy profession- beyond. Our confidence comes the words of Maya Angelou: “Let al—regardless of practice setting, from knowing that when we stand nothing dim the light that shines role, or stage of career—feels that together—as an Association and from within.” Despite the pres- NCAP is their organization, one as a profession—we are capable sures facing healthcare and the they are proud to be part of and of extraordinary progress. relentless demands on our time, engaged in. the light of this profession contin- Gratitude for the Opportunity Strategic Planning: Lifting Our ues to shine—brightly, boldly, and to Serve Vision Higher unwaveringly. My holiday wish for our profession is simple: that As I look back on the past year, I This fall, the NCAP Board of Direceach of you feels that light reflect- am filled with gratitude. Serving tors embarked on a comprehened back to you. That you feel val- as your Executive Director is an sive strategic planning process ued. Supported. Essential. honor I never take lightly. I am framed around two overarching thankful every day for our mem- goals: advancing practice transMy Wish for Our Association bers’ trust, their courage to inno- formation and optimizing member experience and engagement.

For NCAP, my wish is equally vate, and their steadfast commit- Achieving these goals will be heartfelt: that we continue trans- ment to improving patient care. a heavy lift—most meaningful forming into a community where Your work inspires our work. Your work in healthcare is. But the path every pharmacy professional in service strengthens our purpose. forward is clear: we must harness North Carolina feels they belong. And your belief in what pharmacy the exceptional care pharmacists Our vision—unchanged for 25 can be propels us toward a future already provide and channel it toyears—remains our North Star: full of possibilities.

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ward securing the standards, au- with the same passion and dethority, and recognition our pro- termination that we bring to advancing pharmacy practice. This fession deserves. is how we grow from being essenPractice transformation is not tial to agencies and stakeholders just about legislative wins; it’s to being essential to every pharabout elevating the pharmacist’s macy professional in North Carorole as an indispensable pro- lina. vider of patient-centered care.

And just as importantly, trans- Living Our Core Values forming the membership experience means fully embracing Our core values—service-orisomething we have long valued ented, trustworthy, accountable, collaborative, forbut must now prioritize: the cre- inclusive, ation of a vibrant, inclusive com- ward-thinking, proactive, and munity in which belonging and rooted in leadership—have long guided our work. In the coming engagement flourish. year, they will guide our transformation into a community of A New Kind of Advocacy belonging and collective accomFor many years, advocacy at NCAP plishment. They call on us not only has primarily meant legislative to deliver value but also to create and regulatory work. That will connection. To not only represent, always be essential, but in 2026, but to uplift. To not only advocate, the Association will also lean into but to inspire. a different passionate-advocate role: member-first engagement. Looking Ahead We will make each decision with members at the forefront. We will In 2026, the work of the Associabuild experiences that feel mean- tion will be as substantial as ever. ingful, rewarding, and energizing. How we do that work—how we We will champion engagement engage, how we listen, how we

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build community—will define our future. NCAP will prioritize cultivating a community where belonging, engagement, and professional identity thrive. This shift is not cosmetic; it is fundamental to sustaining a strong and unified profession.

My holiday wish is that this season brings each of you much rest, joy, and a renewed sense of purpose; and as we step into the new year, may we move forward with a shared commitment to each other and to the extraordinary potential of our profession. Together, we will continue to grow an Association that is not only essential but exceptional.

From my desk to yours, thank you for the privilege of serving you.

I look forward with excitement, gratitude, and unwavering optimism for all we will accomplish together.

Pharmacy Proud, Penny

•From the NCAP President• Tom D’Andrea, RPh

Leading Forward: A Call to Serve the Future of Pharmacy We can cultivate an environment where new pharmacists feel empowered to grow and share their ideas. Your experience can guide My tenure as President for the them. Your expertise can shape North Carolina Association of their practice.

Pharmacists (NCAP) is coming to an end, and I have enjoyed work- First, leadership starts where you ing with Penny Shelton, Executive stand. Lead by example—be the Director, the NCAP staff, the NCAP colleague who calmly questions Board, and the membership at a policy, who champions patient large. As I leave my role, I would education, and who treats every like to encourage everyone to ex- team member’s input with replore leadership opportunities spect. When we act with intention in NCAP. Now is the time to step and purpose, trust grows, and our forward and embrace leadership association gets stronger. roles within our association. I urge each one of you to reflect Second, leadership is collective. on your own experiences. Think True leaders elevate others, build about the knowledge you have strong teams, and foster a culgained and the lessons you have ture of collaboration. Pharmacy learned. This is your opportunity is a complex web of pharmacists, to pass that wisdom on to the next technicians, students, and clinicians. A leader listens, coordigeneration of pharmacists. nates, and delegates. They mentor Leadership is not reserved for a new members and create space select few. It is a calling that every for interprofessional voices. Leadone of us can answer. Leadership ership is about aligning diverse in our pharmacy association isn’t strengths toward a shared goal. a title you wear; it’s a responsibility you can shoulder for every member who joins NCAP. Leadership in pharmacy means guiding teams, shaping safer practices, and elevating patient care. When we take on leadership roles, we do not just elevate ourselves. We elevate our profession. We create a ripple effect that inspires those around us to strive for excellence.

Third, leadership is an action you can take today. I understand that stepping into a leadership role can be daunting. It may feel uncomfortable or unfamiliar. However, I want you to remember that leadership is not about having all the answers. It is about being willing to learn and adapt. It is about being open to new perspectives.

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Step into a role in an NCAP committee, spearhead a project, or organize a patient-centered initiative. The beauty of leadership is that every small, well-executed effort creates momentum that carries our whole profession.

So, I will challenge each of you today. Step forward. Take on leadership roles within NCAP, and let your voice be heard. Share your experiences. Inspire others to lead. Together, we can shape the future of pharmacy. Together, we can ensure that our profession continues to thrive. Let us lead with purpose and pave the way for those who will follow in our footsteps.

Pharmacy Strong, Tom

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Thyroid Disorder Nuances

By: Dr. Ivonne Marie Santiago Lopez, Dr. Ruthanne Baird, and Dr. Kristen L. Keen

Thyroid disorders, particularly hypothyroidism and hyperthyroidism, affect millions globally, with a disproportionate impact on women, who are 5 to 8 times more likely to develop thyroid dysfunction. (1) In the United States, over 20 million individuals are currently living with thyroid disease, and approximately 12% of the population is expected to develop a thyroid disorder in their lifetime. (1) Despite its widespread prevalence, treatment paradigms have remained largely unchanged for decades.

Hypothyroidism, often caused by autoimmune conditions such as Hashimoto’s thyroiditis, can significantly impair quality of life, presenting with symptoms like fatigue, weight gain, cold intolerance, depression, dry skin, and slowed cognitive function. (1,2) While traditional therapies such as levothyroxine and desiccated thyroid extract (e.g., pork thyroid) are effective for most, some patients do not respond adequately to standard regimens. (2) Fortunately, new treatments are emerging that may offer additional options and improved outcomes for patients with suboptimal responses.

The thyroid gland, located anterior to the trachea, produces thyroxine (T4) and triiodothyronine (T3), hormones essential for regulating metabolism, cardiovascular health, and neurological function.

(3) These hormones are controlled through a negative feedback mechanism involving thyroid-stimulating hormone (TSH) released by the pituitary gland. In Hashimoto’s thyroiditis, autoimmune-mediated destruction of thyroid tissue leads to low thyroxine and triiodothyronine levels, with a compensatory rise in TSH. (3) The prevalence of thyroid disorders has risen significantly from 2.54% to 5.05% between 1999 and 2018, driven by risk factors such as obesity, low socioeconomic status, and limited educational access. (2) One in eight women is affected, highlighting the importance of early detection and tailored care, particularly among vulnerable populations. (2)

• • • •

tection of Thyroid Dysfunction 2012: ATA and AACE Guidelines for Hypothyroidism in Adults 2014: ATA Guidelines for Treatment of Hypothyroidism 2016–2018: Guidelines for Hyperthyroidism, Thyrotoxicosis, and Graves’ Disease 2023: ETA Guidelines for Thyroid Nodule Management

These updates emphasize individualized treatment, the integration of autoimmune markers, and special considerations for pregnancy and comorbidities. As such, it is increasingly essential for pharmacists to stay informed about emerging therapies, current research, and their expanding role in patient-centered thyroid care.

One exciting area of research involves metformin, a medication traditionally used for type 2 diabetes, which has shown promising effects in patients with Hashimoto’s thyroiditis and subclinical hypothyClinical guidelines have evolved in roidism. A 2020 meta-analysis reresponse to this rising burden: vealed that metformin significantly reduced thyroid peroxidase antibodies (TPOAb) and thyroglob• 2000: American Thyroid Assoulin antibodies (TgAb), lowered thyciation (ATA) Guidelines for DePage 8

roid-stimulating hormone levels, and improved insulin sensitivity as measured by the Homeostatic Model Assessment for Insulin Resistance (HOMA-IR), a calculation to estimate insulin resistance. (4) These findings suggest a potential role for metformin in modifying both autoimmune thyroid activity and metabolic dysfunction. The hypothesized mechanisms include adenosine monophosphate-activated protein kinase (AMPK) activation, modulation of the Th17/Treg cell balance, and reduced lymphocytic infiltration of the thyroid. (4) While metformin is not currently approved for the treatment of thyroid disease, its potential dual benefit warrants further investigation. Larger, long-term, multi-center studies are needed to confirm its efficacy and safety in this context. Pharmacists should stay informed about these emerging developments, as they may offer new avenues for individualized, evidence-based care in patients with overlapping endocrine and autoimmune conditions.

Levothyroxine and triiodothyronine combination therapy is another potential option for patients who do not respond well to levothyroxine monotherapy. (5,6) Research has demonstrated that combining levothyroxine with triiodothyronine may alleviate symptoms in patients who continue to experience discomfort despite standard therapy.

(5,6) Though side effects are generally low, pharmacists must be vigilant when managing combination therapy to ensure appropriate dosing and minimize risks.

An exciting and emerging therapeutic avenue for Hashimoto’s thyroiditis is stem cell therapy, particularly mesenchymal stem

cell (MSC) therapy. (7) Known for their regenerative and immunomodulatory properties, MSCs may help repair damaged thyroid tissue while suppressing autoimmune activity by inhibiting immune cell proliferation and promoting regulatory T cells. (6) Preclinical studies and early-phase clinical trials have demonstrated MSCs’ potential to reduce thyroid inflammation and restore thyroid function.

(7) In addition, combination therapy using MSCs alongside immunomodulatory agents such as corticosteroids or immunosuppressants has been suggested to enhance efficacy by further modulating the immune response. (7) Low-dose naltrexone (LDN) has theoretical immunomodulatory benefits but lacks high-quality evidence in thyroid disease. (8,9) Studies to date show inconsistent results and no significant changes in thyroid hormone levels or medication use. Despite these promising results, there are still significant challenges to overcome, including high cost, delivery and administration complexities, immune rejection risk, ethical considerations, and limited longterm clinical data. (7) As such, MSC therapy remains experimental but holds considerable promise as a future strategy in the management of autoimmune thyroid diseases like Hashimoto’s.

Hyperthyroidism, often treated with methimazole, is a condition in which the thyroid produces excess thyroid hormones. (10) Methimazole works by inhibiting the production of thyroid hormones, and clinicians must be aware of potential side effects, including agranulocytosis (a significant drop in white blood cells, WBC) and hepatotoxicity. (10) Although routine monitorPage 9

ing of WBC counts is not universally recommended due to rare and often sudden onset of agranulocytosis, pharmacists should advise patients to seek immediate medical attention if they develop symptoms such as fever or sore throat, especially within the first 90 days of therapy, when risk is highest. (10) Liver function tests may also be monitored periodically, particularly if symptoms like jaundice, dark urine, or right upper quadrant pain occur.

Thyroid eye disease (TED) is an autoimmune inflammatory disorder most associated with Graves’ disease. (11) It affects the orbital tissues, leading to symptoms such as proptosis, eyelid retraction, diplopia, and, in severe cases, vision loss from optic nerve compression. (11) For patients with hyperthyroidism who are unresponsive to medications or prefer a definitive treatment, radioiodine therapy remains a standard option. (11) However, it should be avoided in individuals with moderate to severe TED, as it can worsen orbital inflammation and eye symptoms. (11) Teprotumumab, a monoclonal antibody targeting the insulin-like growth factor-1 receptor (IGF-1R), has shown promise as a treatment for thyroid eye disease. (11) By inhibiting IGF-1R, teprotumumab reduces inflammation and swelling behind the eyes. (11) It is particularly beneficial for patients who have not responded to steroids or surgery. (11) For more severe cases of TED, orbital decompression and strabismus surgery may provide relief. (11) Early referral to an ophthalmologist is critical, as these surgeries should only be performed once the disease has stabilized to avoid complications. (11)

Thyroid disorders are common, but with appropriate treatments, patients can manage their conditions effectively. While traditional therapies remain the cornerstone of treatment, emerging options such as metformin, levothyroxine/triiodothyronine combination therapy, and teprotumumab may change the way thyroid conditions are managed in the future. Pharmacists are essential in ensuring the success of these therapies by monitoring side effects, providing patient education, and promoting personalized care. Staying informed and adaptable will enable pharmacists to provide the best possible care for patients with thyroid disorders.

Authors: (Corresponding) Ivonne Marie Santiago Lopez, PharmD, MSPH1,2 (imsantiagolp1123@campbell.edu); Ruthanne Baird, PharmD, BCPS2; Kristen L. Keen, PharmD2 1 Campbell University School of Pharmacy; Health Sciences and 2 CFV Betsy Johnson and Central Harnett Hospitals References

1. American Thyroid Association.

(2024, February 12). General Information / Press Room | American Thyroid Association. https://www.thyroid.org/ media-main/press-room/ 2. Zhnag, X., Wang, X., Hu, H., Qu, H., Xu, Y., & Li, Q. (2023). Prevalence and Trends of thyroid disease among adults, 1999 – 2018. Endocrine Practice, 23, 875 – 880. https://.org/10.1016/j. eprac.2023.08.006 doi 3. Stone. M.B., & Wallace, R.B. (Eds).

(2003). Pathophysiology and diagnosis of thyroid disease. In Medicare coverage of routine screening for thyroid dysfunction (p.2). National Academies

press. https://www.ncbi.nlm.nih.gov/ books/NBK221541 4. Jia X, Zhai T, Zhang J. Metformin reduces autoimmune antibody levels in patients with Hashimoto’s thyroiditis: A systematic review and meta-analysis. Autoimmunity. 2020;53(6):353– 361. doi:10.1080/08916934.2020.178 9969 5. Vargas-Uricoechea H, Wartofsky L. LT4/LT3 Combination Therapy vs.

Monotherapy for Persistent Symptoms of Hypothyroidism: A Systematic Review. Int J Mol Sci. 2024;25(17):9218. doi:10.3390/ijms25179218 6. Gottwald-Hostalek, U., & Tayrouz, Y. (2024). A review of the safety of triiodothyronine in combination with levothyroxine for the management of hypothyroidism. Taylor & Francis: Endocrinology, 40(12), 2109 – 2116. https://doi.org/10.1080/03007995.20 24.2435460 7. View of stem cell therapy for Hashimoto’s disease – a promising treatment method? QS.https://apcz. umk.pl/QS/article/view/53856/39490 8. Raknes G, Smabrekke L. No change in the consumption of thyroid hormones after starting low dose naltrexone (LDN): a quasi-experimental before-after study. BMC Endocr Disord.

2020;20(1):151. doi:10.1186/s12902020-00630-4 9. Phung Khong, K., Smabrekke, L., & Raknes, G. (2017, April 20). Alteration of prescription-only drug utilization by low dose naltrexone users with hypothyroidism, a cohort study based on the Norwegian prescription database from 2011 – 2015. Science Direct. Retrieved March 3, 2025, from https://www-sciencedirect com.procy.campbell.edu/science/article/pii/ S1551741117302152 10. Ross DS, Burch HB, Cooper DS, et al. 2016 American Thyroid Association Guidelines for Diagnosis and Management of Hyperthyroidism and Other Causes of Thyrotoxicosis [published correction appears in Thyroid.

2017 Nov;27(11):1462. doi: 10.1089/ thy.2016.0229.correx.].

Thyroid.

2016;26(10):1343-1421. doi:10.1089/ Page 10

thy.2016.0229 11. Hang TD, Stocker DJ, Chou EL, Burch HB. 2022 Update on Clinical Management of Graves’ Disease and Thyroid Eye Disease. Endocrinol Metab Clin North Am. 2022;51(2):287–384. doi:10.1016/j.ecl.2021.12 12. Gottwald-Hostalek, U., & Tayrouz, Y. (2024). A review of the safety of triiodothyronine in combination with levothyroxine for the management of hypothyroidism. Taylor & Francis: Endocrinology, 40(12), 2109 – 2116. https://doi.org/10.1080/03007995.20 24.2435460

Cardiovascular Implications of Semaglutide Discontinuation for Patients Who Lost Coverage

By: Dr. Damian T. Hardison, Lauren Hairston, PharmD Candidate, Shaleen Ghosh, PharmD Candidate, Dr. Alissa Clayton, Dr. Shelby Tungate Lopez, Dr. Anne M. Komé, and Dr. Andrea D. Coviello

Abstract

year ASCVD risk increased by 0.2% by the end of the study period.

Changes in LDL were difficult to Objective: The study objective was capture due to limited monitoring to assess the cardiovascular impli- during the study period. cations of discontinuing semaglutide in patients who lost coverage, Conclusions: After seven months, including those with cardiovascular there was no incidence of MACE disease. in patients who lost coverage and Study Design: This was a retrospective chart review of patients at a large academic medical center with BMI ≥27 kg/m2 who were treated with semaglutide 1.7 mg or 2.4 mg for at least three months prior to April 1, 2024.

Methods: Patients enrolled in the State Health Plan (SHP) who lost semaglutide coverage were reviewed between May 1, 2024, and December 1, 2024. The primary outcome was the incidence of major adverse cardiovascular events (MACE). Secondary outcomes included changes in weight, LDL cholesterol, and ASCVD risk score.

Results: Of 394 patients screened, 84 patients with SHP met the inclusion criteria. 97.6% of patients did not have CVD, and MACE were not observed. Patients experienced a 7.4 lb weight gain, and their ten-

discontinued semaglutide. However, the upward trend in weight and ASCVD risk suggests that discontinuation of therapy may worsen cardiometabolic parameters longterm.

Background

Glucagon-like peptide-1 receptor agonists (GLP-1 RAs), with or without glucose-dependent insulinotropic polypeptide (GIP), are indicated for type 2 diabetes (T2D) and chronic weight management. Multiple landmark trials have demonstrated cardiovascular (CV) risk reduction in patients with these conditions taking GLP-1 RA. (1-4) Further, clinical benefit of incretin therapy has been observed in individuals with obstructive sleep-apnea (OSA), heart failure (HF) with preserved ejection fraction (HFpEF), and chronic-kidPage 12

ney disease (CKD); data supporting the use of GLP-1 RA in metabolic dysfunction-associated steatohepatitis were recently published. (5-12) The robust evidence highlighting the cardio-kidney metabolic benefits of GLP-1 RA-based therapies has led to updates in package labeling for many products, including subcutaneous semaglutide. (13) The indication for subcutaneous semaglutide approved for chronic weight management (WegovyÒ, Novo Nordisk Inc.; referred to as semaglutide-WGV hereafter) expanded in March 2024 to include the reduction of major adverse cardiovascular events (MACE) in patients with established cardiovascular disease (CVD) and body mass index (BMI) ≥27 kg/m2 based on results from the SELECT trial, which prompted many healthcare payers to add semaglutide-WGV to formulary for individuals with comorbid CVD and overweight or obesity. (4,13) The North Carolina State Health Plan (SHP) provides health and prescription insurance for more than 700,000 state employees, retirees, and families across the state. (14, 15) SHP covered Semaglutide-WGV until April 1, 2024, when the plan removed injectable weight loss med-

ications (WLM) from the formulary due to unsustainable costs of $170 million in one year (anticipated to rise to $1 billion after six years).

This resulted in the discontinuation of therapy for nearly 25,000 people. (14,15) Currently, there is a lack of literature evaluating the real-world impact of discontinuing semaglutide-WGV in people who lose coverage of therapy through their insurance.

Objective The objective of this study was to assess the CV implications of discontinuing semaglutide-WGV in patients who lost coverage, including people with CVD. Methods This study was a retrospective, observational chart review assessing patients across various outpatient practice sites within a large academic medical center, including bariatric surgery, cardiology, endocrinology, family medicine, and internal medicine clinics. Patients aged 40 years and older with a baseline BMI ≥ 27 kg/m2 and treated with semaglutide-WGV 1.7 mg or 2.4 mg once weekly for at least three consecutive months as of April 1, 2024, were included in the study.

All patients were required to have primary prescription insurance through SHP. A comparator group was not used for this study due to the small number of individuals within an alternate health plan who met eligibility criteria and had access to semaglutide-WGV during the study period. Initial inclusion criteria required a CVD diagnosis; however, due to a low number of patients with baseline CVD, this

requirement was removed prior to data collection and analysis. Patients were excluded if they had a diagnosis of diabetes prior to semaglutide-WGV initiation, MACE within six weeks of semaglutide-WGV discontinuation, a diagnosis of familial hypercholesterolemia, or were incarcerated, pregnant, had changed insurance plans during the study period (May 1, 2024, to December 1, 2024), or transitioned to another incretin-based therapy, including compounded formulations.

Patients were identified through an electronic medical record query with assistance from an NC Data TraCS analyst. Charts were manually reviewed to verify adherence to inclusion and exclusion criteria, and patients meeting eligibility criteria were assessed for primary and secondary endpoints. The primary outcome was the incidence of MACE during the study period. Secondary outcomes included change in weight and BMI, change in LDL cholesterol, change in 10-year ASCVD risk score, the incidence of new-onset HF, CAD, PAD, valvular disease, angina, or T2D, death from any cause, and the initiation and/ or adjustment of concurrent WLM (bupropion, naltrexone, phentermine, diethylpropion, topiramate, other GLP-1 RA/GIP, orlistat, metformin). Medications such as bupropion, naltrexone, topiramate, and metformin were excluded from analysis if not prescribed specifically for weight management. Changes in endpoints were assessed between May 1, 2024, and December 1, 2024. This study was approved by the institutional investigational review board. Data were analyzed using descriptive statistics, with non-normally distributed data reported as median (IQR).

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CVD was defined by a history of myocardial infarction (MI), cerebrovascular accident (CVA), transient ischemic attack (TIA), peripheral arterial disease (PAD), coronary artery disease (CAD), HF, valvular disease, or angina. The primary outcome of MACE was defined by the occurrence of CV death, nonfatal MI, nonfatal stroke or TIA, or hospitalization for a CV event at any point during the study timeframe.

Manual chart review of primary and secondary endpoints consisted of review of all chart notes (both ambulatory care visits and hospitalization notes), all pertinent lab values, and assessment of documentation of new problems and/ or ICD-10 codes during the study period (May 1, 2024, to December 1, 2024). Initiation and adjustment of concurrent weight-loss medication were verified using Surescripts data, with ongoing refills of the prescription and no more than six weeks between refills within a 30day prescription period. Changes in LDL cholesterol, weight, BMI, and ASCVD risk score were calculated as the difference between baseline (prior to May 1, 2024) and end-ofstudy (December 1, 2024) values.

Any weight or BMI greater than six months and LDL greater than one year from the beginning or end of the review period were not recorded or included in data analysis.

Results A total of 394 patients were screened for eligibility, with 310 excluded primarily because they were not taking maintenance doses of semaglutide-WGV (1.7 mg or 2.4 mg) for at least three consecutive months as of April 1, 2024 (Table 1). Eighty-four patients with SHP insurance met the inclusion

Table 1: Rationale for Patients Excluded from Study Reasons for Study Exclusion (n = 310)

No. of patients (%)

Not on semaglutide-WGV 1.7 mg or 2.4 mg once weekly doses starting in 2023 and on as of 1/1/2024 for at least 3 months Incorrect or change in insurance during study timeframe

175 (56.5) 43 (13.8)

Diagnosis of T2D

38 (12.2)

Switched to an alternative GLP1 RA or GLP1/GIP during study timeframe Switched to a compounded GLP1 RA or GLP1/GIP at some point during study timeframe SHP patient who lost semaglutide-WGV coverage but remained on semaglutideWGV Lapses in fill history by at least 6 weeks

30 (9.6)

CV event within 6 weeks of semaglutide-WGV discontinuation

2 (0.7)

BMI <27 prior to semaglutide-WGV initiation

1 (0.3)

In research study with unknown GLP1 RA allocation

1 (0.3)

Pregnant on or after 1/1/2023

1 (0.3)

criteria for this study. Patients were predominantly female (83.7%), 52 years of age, Caucasian (57%), had class I obesity (median baseline BMI of 34.2 kg/m2), and did not have established CVD (97.6%). Furthermore, most patients (83.7%) were not taking adjunctive WLM

28 (9.0) 14 (4.5) 9 (2.6)

while taking semaglutide-WGV at baseline (Table 2). MACE were not observed, and no new diagnoses of CVD or T2D were made during the study period (Table 3). The median 10-year ASCVD risk score increased by 0.2% for patients with SHP. Median weight and BMI increased by

Table 2: Baseline Characteristics

All data is presented as the number of patients (%) unless otherwise specified

Characteristic

SHP (n=84)

Age in years, median (IQR)

52 (11)

Female

70 (83.3)

Race White Black Other Smoking status Never Former Daily CVD None CAD Hypertension CKD 10-year ASCVD risk, median (IQR) Weight (lbs), median (IQR)

47 (56) 31 (36.9) 6 (7.1) 68 (81) 15 (17.9) 1 (1.2)

2 (2.4) 2.1 (3.5) 213.6 (73.7) 34.3 (9.8)

LDL (mg/dL), median (IQR)

105 (36.8)

Medications ACEi/ARB Statin Aspirin Beta-blocker MRA PCSK9i Weight Loss Medication None Metformin Topiramate Phentermine Bupropion Days since last semaglutide-WGV administration up to 12/1/2024, median (IQR)

Discussion

82 (97.6) 2 (2.4) 41 (48.8)

BMI (kg/m2), median (IQR)

7.4 lb and 1 kg/m2 (Figure 1), respectively, and LDL decreased by 1 mg/dL. Of note, for the two patients with established CVD in this study, one patient had a 22.4 lb weight regain, and the other had a 9.9 lb weight regain. Multiple patients who lost semaglutide-WGV coverage lacked documentation indicating that an alternative WLM was started during the study period. Phentermine, topiramate, and metformin were the most frequently prescribed agents after semaglutide-WGV discontinuation (Supplemental 1). Conversely, of those who transitioned to an alternate WLM, 28% of patients on phentermine, 47% of patients on topiramate, and 53% of patients on metformin did not maintain therapy by the end of this study period (Supplemental 1). Most patients who were excluded due to switching from semaglutide-WGV to an alternate FDA-approved or compounded GLP-1 RA or GLP-1RA/GIP formulation maintained therapy at the end of the study period (Supplemental 1).

25 (29.8) 12 (14.3) 7 (8.3) 6 (7.1) 5 (6) 1 (1.2) 71 (84.5) 6 (7.1) 4 (4.8) 2 (2.4) 2 (2.4) 230 (81)

Abbreviations: ACEi/ARB = angiotensin-converting enzyme inhibitor/angiotensin receptor blocker; CAD = coronary artery disease; CKD = chronic kidney disease; CVD = cardiovascular disease; MACE = major adverse cardiovascular events; MRA = mineralocorticoid receptor antagonist; SHP = North Carolina State Health Plan; semaglutide-WGV = Wegovy®; PCSK9i = proprotein convertase subtilisin/kexin type 9 inhibitors

Page 14

The Obesity Medicine Association (OMA) acknowledges four pillars of chronic weight management: behavioral modification, physical activity, nutrition therapy, and medical interventions. (16) In October 2023, the SHP Board of Trustees voted to disrupt the standard of care by removing liraglutide, semaglutide, and tirzepatide products approved for chronic weight management from the prescription formulary effective January 1, 2024.

Patients who were established on these agents prior to this date could continue therapy until April 1, 2024, when coverage for all SHP

Table 3: Primary and Secondary Endpoints

All data is presented as the number of patients (%) unless otherwise specified

Study Endpoints

SHP (n=84)

Primary Endpoint Incidence of MACE

0 (0)

Death from any cause

0 (0)

New diagnosis of CVD

0 (0)

New diagnosis of T2D

0 (0)

Secondary Endpoints

LDL at end of study period (mg/dL), median (IQR)

104 (30)

Change in LDL (mg/dL), median* 10-year ASCVD at end of study period (%), median (IQR)

-1 2.3 (3.6)

Change in 10-year ASCVD (%), median BMI at end of study period (kg/m2), median (IQR)

+0.2 35.3 (11.3)

Change in BMI (kg/m2), median Weight at end of study period (lb), median (IQR)

+1 221 (69.9)

Change in weight (lb), median (IQR)

+7.4

*Change in LDL for SHP is based on 19 patients, as 66 patients did not have an updated LDL for comparison.

beneficiaries would cease for the foreseeable future. (14,15) An article by Dellgran et al. called out SHP, noting that this strategy for managing GLP-1 RA drug spend is unethical from a health care perspective.

(17) Consequently, the decision to

remove WLM from the SHP formulary due to unsustainable costs has been met with relentless backlash from key stakeholders across the state, including patients, healthcare providers, and obesity medicine advocates. With mounting pressure,

Figure 1: Changes in Weight and BMI for Patients Who Lost Coverage A)

B)

Panel A represents median weight change from baseline (4/1/2024) to the end of the study (12/1/2024) for patients with SHP insurance. Panel B represents the median BMI change from baseline to the end of the study for patients with SHP insurance.

Page 15

new indications, and steadfast advocacy by North Carolinians, SHP is reconsidering its decision and investigating measures to reinstate WLM coverage for state employees through collaboration with the newly formed North Carolina Obesity Society. (18,19) In this retrospective review, there was no incidence of MACE for patients who lost coverage. Patients experienced anticipated weight regain, though the average weight regain was lower than observed in the STEP-1 extension and SURMOUNT-4 studies, where discontinuation of semaglutide (+25.3 lb) and tirzepatide (+24.4 lb) led to significant weight regain within one year in individuals without CVD. (20,21) The results in this retrospective study may be attributed to a shorter study period (32 weeks versus ≥ 52 weeks in randomized studies) and a higher proportion of patients taking concurrent WLM (45%) compared to the STEP-1 extension (9.2%) and SURMOUNT-4 (0%) trials. (20,21) Of note, weight gain was highly variable as several patients (n =17, 20.2%) experienced a > 20 lb regain, with two patients (2.4%) gaining over 40 lb in seven months. It is important to note that the two patients with CVD in this study both experienced significant weight regain (24.4 lbs and 9.9 lbs), putting them at higher CV risk. The maximum potential for weight gain may have been blunted by individuals who continued to experience weight loss by optimizing alternate WLM and intensifying behavioral and lifestyle interventions, which were difficult to assess through chart review.

While the changes were minimal, the 10-year ASCVD risk score increased slightly for patients with

Supplemental Appendix Figure 1: Initiation and Titration of Alternate Weight Loss Medications

Abbreviations: GLP-1 = glucagon-like peptide-1 receptor agonist; GLP1/GIP = glucagon-like polypeptide 1 receptor agonist/glucose-dependent insulinotropic polypeptide agonist; WLM = weight loss medication; SGLT2i = sodium glucose cotransporter 2 inhibitors

ed meaningful clinical endpoints and an expanded CV composite that included hospitalizations for CV indications, such as HF exacerbations.

This is important, as the SELECT trial used a standard three-point MACE (history of non-fatal stroke, non-fatal MI, or CV death) that does not capture the expanded CV benefit of semaglutide observed in HFpEF. (7) Furthermore, our study included patients who were on concurrent therapies for chronic weight management and evaluated the adjustment of alternate WLM for insight into post-GLP-1 RA therapies that patients were receiving, which is atypical in clinical trials. Lastly, this study provides real-world data on the impact of loss of semagluTo our knowledge, this is the first tide-WGV in a cohort of patients real-world study to assess the CV across multiple specialty clinics at a implications of discontinuing sema- large academic medical center. Givglutide-WGV in patients who lost en ongoing consideration of adding coverage, including people with semaglutide-WGV back to the SHP CVD. Strengths of this study includ- formulary and the threat of other

SHP; this aligns with changes in cardiometabolic parameters seen in other trials. (20,21) An increase in ASCVD risk of 0.2% corresponds to an extra two events per 1,000 patients over the next 10 years; thus, a larger increase in 10-year ASCVD risk would be expected if assessed over several years rather than seven months. Interestingly, LDL decreased slightly, with a median decrease of 1 mg/dL. This differs from studies showing worsening lipid levels after stopping semaglutide. (20,21) This discrepancy may be a chance finding, given that the change in LDL was based on 19 of 84 patients due to inconsistent lipid panel monitoring frequency.

Page 16

insurance plans discontinuing coverage of WLM, this research is highly relevant and timely. (18) This study had several limitations, including a retrospective design and a small sample size, which limit generalizability and constrain statistical analysis. The lack of patients with an official CVD diagnosis was a major constraint, as the original intent was to assess patients with established CVD who discontinued semaglutide-WGV to align with the patient population followed in the SELECT trial. Additional setbacks include the lack of assessment of the total duration of semaglutide-WGV therapy, as longer treatment durations may have had a greater impact on baseline cardiometabolic parameters, such as ASCVD, lipids, and blood pressure (which was not assessed during this study), compared to shorter intervals. Additionally, the duration of anticipated

cardio-protection after cessation of GLP-1 RA therapy has not been determined. Lifestyle modification interventions were not assessed, which is another limitation. Lastly, the seven-month study period is a limiting factor, as participants in the SELECT trial were followed for approximately 3.3 years to observe a difference in MACE. (4) At the time of this publication, SHP had not reinstated coverage of semaglutide-WGV. In the interim, the next steps include following the cohort of patients with SHP beyond one year for additional insight regarding changes in their cardiometabolic parameters. Future real-world studies evaluating the CV impact of discontinuing semaglutide-WGV should be conducted in larger groups for longer durations and include patients with established CV disease.

ty Medical Association, or The Obesity Society, further limiting options for patients who lose coverage of an approved product. (22-24) Conclusion After a seven-month period, there was no incidence of MACE for patients with or without comorbid CVD who lost coverage and discontinued semaglutide-WGV at a large academic medical center. Extending the observation period to gather additional insights may enhance these findings; however, the upward trend in weight and ASCVD risk suggests that discontinuing therapy may worsen cardiometabolic parameters in the long term. Further real-world research evaluating the implications of stopping cardioprotective GLP-1 RA in patients with or at high risk for CVD is necessary to require healthcare payers to look beyond finances and maintain coverage of incretin-based WLM.

•

consulting fees from Camurus Pharmaceuticals, Dexcom Incorporated, and Lexicomp Wolters-Kluwer, and serves as the vice president and board member of the North Carolina Obesity Society.

Andrea D. Coviello has received consulting fees from Novo Nordisk, Intuitive Surgical, HANMI Pharmaceuticals, IQVIA, NewAmsterdamPharma, and WellWorksforYou, and serves as a board member of the North Carolina Obesity Society.

Authors: Damian T. Hardison, PharmD, PGY2 Ambulatory Care Pharmacy Resident1; Lauren Hairston, B.S., Student Pharmacist Class of 2025 2; Shaleen Ghosh, B.S., Student Pharmacist Class of 20252; Alissa Clayton, PharmD, Clinical Pharmacist Practitioner - Generalist1; Shelby Tungate Lopez, PharmD, Clinical Pharmacist Practitioner – Access to and affordability of med- Cardiology1,2; (corresponding) Anne ication for chronic weight manage- M. Komé, PharmD, Clinical Pharmament remain insurmountable bar- cist Practitioner – Endocrinology1 riers for many people. Payers and (Anne.Kome@unchealth.unc.edu) employers frequently weigh the Andrea D. Coviello MD, Director – financial risk, benefit, and return Medical Weight Management Proon investment when offering plans gram3 that cover WLM, with decisions that directly impact patient care Affiliations: and outcomes. With WLM cover- 1University of North Carolina Medage subject to frequent change de- ical Center, Chapel Hill, North Carspite the growing list of approved olina indications, it is imperative that 2University of North Carolina Eshadvocacy and efforts to keep these elman School of Pharmacy, Chapel life-preserving medications avail- Hill, North Carolina able across North Carolina are sus- 3Division of Endocrinology and tained.

Metabolism, Department of Medi-

Intermittent shortages of lower-strength semaglutide-WGV (0.25, 0.5, and 1 mg) prior to and during the study period may have prohibited patients with either insurance plans from initiating, titrating, and achieving maintenance doses. Twenty-eight (8.2%) patients were excluded because they switched to compounded incretin therapy after losing semaglutide-WGV coverage. Although compounded incretin preparations were initially perceived to be more cost-effective than FDA-approved agents, compounded products pose uncertain health risks, and direct-to-patient programs, such as Lilly Direct and Novocare Pharmacy, now offer semaglutide and tirzepatide at comparable prices.

Nevertheless, use of compounded incretins is not endorsed by the Conflicts of Interest Disclosure: American Diabetes Association, the Obesity Action Coalition, the Obesi- • Anne M. Komé has received Page 17

cine, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina

References

1. Gerstein HC, Colhoun HM, Dagenais GR, et al. Dulaglutide and cardiovascular outcomes in type 2 diabetes (REWIND): a double-blind, randomised placebo-controlled trial. Lancet. 2019;394(10193):121130. doi:10.1016/S01406736(19)31149-3.

2. Williams TC, Stewart E. Semaglutide and Cardiovascular Outcomes in Patients with Type 2 Diabetes.

N Engl J Med. 2017;376(9):891. doi:10.1056/NEJMc1615712.

3. Marso SP, Daniels GH, Brown-Frandsen K, et al. Liraglutide and Cardiovascular Outcomes in Type 2 Diabetes. N Engl J Med. 2016;375(4):311-322. doi:10.1056/NEJMoa1603827.

4. Lincoff AM, Brown-Frandsen K, Colhoun HM, et al. Semaglutide and Cardiovascular Outcomes in Obesity without Diabetes [published online ahead of print, 2023 Nov 11]. N Engl J Med. 2023;10.1056/ NEJMoa2307563. doi:10.1056/NEJMoa2307563.

5. Malhotra A, Grunstein RR, Fietze I, et al. Tirzepatide for the treatment of obstructive sleep apnea and obesity. N Engl J Med. Oct 3 2024;391(13):1193-1205. doi:10.1056/NEJMoa2404881 6. Kosiborod MN, Abildstrøm SZ, Borlaug BA, et al. Semaglutide in patients with heart failure with preserved ejection fraction and obesity. N Engl J Med. Sep 21 2023;389(12):1069-1084. doi:10.1056/NEJMoa2306963.

7. Packer M, Zile MR, Kramer CM, et al. Tirzepatide for heart failure with preserved ejection fraction and obesity. N Engl J Med. Jan 30 2025;392(5):427-437. doi:10.1056/NEJMoa2410027.

8. Perkovic V, Tuttle KR, Rossing P, et al. Effects of semaglutide on chronic kidney disease in patients with type 2 diabetes. N Engl J Med. Jul 11 2024;391(2):109-121. doi:10.1056/NEJMoa2403347 9. Armstrong MJ, Gaunt P, Aithal GP,

et al. Liraglutide safety and efficacy in patients with non- alcoholic steatohepatitis (lean): A multicentre, double-blind, randomised, placebo-controlled phase 2 study. Lancet. Feb 13 2016;387(10019):6796 9 0 . d o i : 1 0 . 1 0 1 6 / s01406736(15)00803-x 10. Newsome PN, Buchholtz K, Cusi K, et al. A placebo-controlled trial of subcutaneous semaglutide in nonalcoholic steatohepatitis. N Engl J Med. Mar 25 2021;384(12):11131124. doi:10.1056/NEJMoa2028395.

11. Loomba R, Hartman ML, Lawitz EJ, et al. Tirzepatide for metabolic dysfunction-associated steatohepatitis with liver fibrosis. N Engl J Med. Jul 25 2024;391(4):299-310. doi:10.1056/NEJMoa2401943.

12. Phase 3 essence trial: Semaglutide in metabolic dysfunction-associated steatohepatitis. Gastroenterol Hepatol (N Y). Dec 2024;20(12 Suppl 11):6-7.

13. Wegovy (semaglutide) [package insert]. Plainsboro, NJ: Novo Nordisk, March 2024.

14. NC state health plan votes to end all coverage for Wegovy and other weight-loss drugs. Updated January 25, 2024. Accessed May 15, 2025. https://www.wral. com/story/nc-state-health-planvotes-to-end-all-coverage-forwegovy-and-other-weight-lossdrugs/21252674/.

15. Statement Regarding GLP-1 Coverage. North Carolina State Health Plan. Updated March 7, 2024. Accessed February 24, 2025. https://www.shpnc.org/ blog/2024/03/07/statement-regardingglp-1-coverage?utm_ source=chatgpt.com 16. The Obesity Medicine Association Four Pillars of Obesity Treatment.

Accessed May 15, 2025. https:// o b e s i t y m e d i c i n e . o rg /a b o u t / four-pillars/.

17. Dellgren J, Emanual E, Persad G. Ethical Approaches to Limiting Overall Costs for Glucagon-Like Page 18

Peptide-1 Receptor Agonists for Weight Management. Annals of Internal Medicine Nov 2024;178(1):1-3. https://doi. org/10.7326/ANNALS-24-01317.

18. Weight loss drug coverage could return for some state workers under proposed NC budget. Updated April 15, 2025. Accessed May 19, 2025. https://www.wral.com/ lifestyle/health/weight- loss-drugcoverage-nc-state-workers-proposed-budget-april-2025/.

19. The North Carolina Obesity Society. Accessed May 15, 2025. https://ncobesitysociety.org/.

20. Wilding JPH, Batterham RL, Davies M, et al. Weight regain and cardiometabolic effects after withdrawal of semaglutide: The step 1 trial extension. Diabetes Obes Metab. Aug 2022;24(8):1553-1564. doi:10.1111/dom.14725.

21. Aronne LJ, Sattar N, Horn DB, et al. Continued treatment with tirzepatide for maintenance of weight reduction in adults with obesity: The Surmount-4 randomized clinical trial. JAMA. Jan 2 2024;331(1):38-48. doi:10.1001/ jama.2023.24945.

22. Neumiller JJ, Bajaj M, Bannuru RR, et al. Compounded GLP-1 and dual GIP/GLP-1 receptor agonists: A statement from the American Diabetes Association. Diabetes Care.

2024;48(2):177- 181. doi:10.2337/ dci24-0091.

23. Fitch A, Auriema A, Bay HE. Compounded peptides: An Obesity Medicine Association Position Statement, Obesity Pillars.

2023;6:100061.https://doi. org/10.1016/j.obpill.2023.100061.

24. Obesity Action Coalition Obesity Care Organizations Issue Joint Statement: Do Not Use Compounded Alternatives to GLP-1 Medications. Updated on January 9, 2024. Accessed May 19, 2025. https://www.obesityaction.org/ wp-content/uploads/GLP-1-Compounded-Alternative- Statement_ Final_Logos-1.pdf.

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Prevalence of Gastrointestinal Bleeding in Inpatients Receiving Oral Anticoagulation with or without Concomitant Antiplatelet Therapy

By: Dr. Ruby Odum, Dr. Carrie Baker, and Dr. Riley Bowers

Abstract Background: The use of antithrombotic therapies, such as oral anticoagulation (OAC) and antiplatelet (APT) agents, has been shown to increase the risk of gastrointestinal (GI) bleeding, a common condition in the hospital setting. In addition, the inappropriate use of APT agents ranges from 15.3% to 58.6%.

Atherosclerotic Cardiovascular Disease.

Results: A total of 273/4188 (6.5%) patients on OAC alone were diagnosed with a GI bleed compared to 292/4032 (7.2%) on OAC and at least one APT agent. Although the prevalence of GI bleeding was higher in the APT group, the difference was not statistically significant (7.2% vs 6.5%, P = 0.095). Within Purpose: To compare the preva- the APT group, 83.2% of patients lence of GI bleed in hospitalized who experienced bleeding were repatients who were receiving OAC ceiving inappropriate APT therapy with or without concomitant APT based on guideline recommendatherapy. tions.

Methods: A retrospective analysis was conducted of patients receiving OAC with or without concomitant APT therapy over a two-year period. The percentage of patients experiencing a GI bleed on OAC alone versus OAC with at least one APT agent was compared. Appropriateness of APT agents was also evaluated using the 2020 ACC Expert Consensus Decision Pathway for Anticoagulant and Antiplatelet Therapy in Patients with Atrial Fibrillation or Venous Thromboembolism Undergoing Percutaneous Coronary Intervention or with

Conclusion: There was an increased prevalence of GI bleed in patients who had APT prescribed concomitantly with OAC, although not statistically significant. Patients receiving inappropriate APT therapy had a significantly higher prevalence of GI bleed than those who were on appropriate APT therapy. These results highlight the need for pharmacist-led education and initiatives, especially focused on de-prescribing APT therapy in patients with indications for OAC. Introduction Page 20

Gastrointestinal (GI) bleeding is a significant medical condition encountered in emergency departments and hospitals. Upper GI bleeds are the most common type of GI bleed, and account for approximately 300,000 hospitalizations in the United States annually, with a mortality rate between 3.5% to 13%. (1,2) Lower GI bleeds account for approximately 20% of GI bleeds and have a mortality rate of around 4%. (3) Common risk factors for GI bleed include advanced age, the use of anticoagulants, antiplatelets (APT), non-steroidal anti-inflammatory drugs (NSAIDs), and certain depression medications, such as selective serotonin reuptake inhibitors and selective norepinephrine reuptake inhibitors. (2) The relationship between antithrombotic medications like oral anticoagulation (OAC) and APT agents and risk for GI bleed has been well-established. (4-6) For example, aspirin monotherapy is associated with a 37% increased risk of GI bleeding, and when used in combination with an antiplatelet such as clopidogrel, the risk for major bleeding increases by 93%. (1) A recent study evaluated risk factors

and management of GI bleed in patients with or without APT and anticoagulation therapy. (2) This study included 2,299 patients, with 20.1% and 2.9% of patients receiving APT and anticoagulation therapy, respectively. The authors concluded there was an association between current APT or anticoagulation usage in patients with a GI bleed and elevated 28-day mortality. They found that 28-day mortality was higher in the anticoagulation group (10.5%) than in the APT group (4.6%). While adding anticoagulation therapy to APT therapy can further increase the risk of bleeding, the authors of this study did not compare the risk of GI bleeding in patients taking both an anticoagulant and APT. (2) A few studies have directly evaluated the incidence of GI bleeding in patients on OAC and at least one APT agent. Among studies comparing the risk of GI bleed when OAC and APT therapies are combined, the risk of major GI bleed is substantially increased. (5-8) The antithrombotic combinations most often studied include anticoagulants like warfarin or dabigatran in addition to aspirin or clopidogrel.

(5-8) A population-based case-control study found the odds ratio for upper GI bleed with the combination of warfarin and aspirin was 5.3 (95% CI, 2.9 to 9.5) compared to 1.8 (95% CI, 1.3 to 2.4) with warfarin monotherapy. (7) Similarly, an analysis of the RELY trial, which compared two doses of dabigatran to warfarin, found that patients on dabigatran who were receiving concomitant APT therapy with either aspirin or clopidogrel had a 30% to 50% increased risk of GI bleed. (9) For patients who require triple ther-

apy with OAC plus dual APT agents, the GI-related and non-GI-related bleeding complications at 30 days range between 9.2% and 20%.

(5) Due to the increased risk of GI and non-GI-related bleed with triple therapy, guidelines now recommend shorter durations of APT therapy in patients who also have an indication for anticoagulation.

(10-12) In patients receiving OAC, the recommended maximum dual antiplatelet therapy (DAPT) duration is four weeks, followed by single antiplatelet therapy (SAPT) for a variable duration of one to twelve months, depending on the patient’s indication. (10-12) For an indication of peripheral artery disease (PAD) or cerebrovascular disease (CVD) post-intervention (surgical repair, endovascular intervention, or carotid stent), SAPT duration is for one to three months in patients on OAC. (10) Patients on OAC who received a bare metal stent (BMS) during percutaneous coronary intervention (PCI) for chronic coronary disease (CCD) should receive at least one month of SAPT with a P2Y12 inhibitor. (10) In patients with acute coronary syndrome (ACS), the recommended duration of SAPT with anticoagulation is twelve months, after which it is recommended to discontinue APT therapy and continue with anticoagulation monotherapy. (10-12) For patients undergoing an elective PCI, after six months, no APT agent is required, and patients may continue with OAC alone. (11) In patients at high risk for bleeding, clinicians can consider discontinuing APT therapy following stent placement as soon as three months in CCD and six months in ACS. (1012) These newer recommendations are based on evidence from several trials that evaluated the safety and Page 21

efficacy of using a direct oral anticoagulant (apixaban, edoxaban, dabigatran) with a P2Y12 inhibitor, most commonly clopidogrel, without aspirin in patients with atrial fibrillation who underwent a PCI. (13) Only two of the five trials in this analysis included patients with a history of GI bleed, which ranged from 0.7% to 5%. (13) Safety data for other combinations of OAC and APT agents, as well as their use in higher-risk populations, is currently lacking.

Despite recent guidelines recommending shorter durations of APT therapy with OAC to reduce bleeding risk in patients requiring longterm OAC, implementing these changes in clinical practice can be challenging. (10-12) Barriers like education and healthcare silos contribute to the challenge of de-prescribing APT agents in practice. (1416) While many patients require antithrombotic agents, the benefits must be juxtaposed with the potential risks. This project aims to examine whether the continued use of APT therapies in combination with OAC increases the risk of GI bleeding in patients requiring long-term OAC compared with those receiving long-term OAC alone.

Methods This was a single-center, retrospective review of patients admitted to a large community hospital between January 1, 2022, and January 31, 2024. Adult patients ≥ 18 years of age who were receiving outpatient OAC with or without concomitant APT therapy were included in this study. Patients were excluded if they were receiving outpatient parenteral anticoagulation, had a GI bleed resulting from trauma, or

were pregnant. This study was ap- patients hospitalized and receiving teristics are summarized in Table proved by the health system’s Insti- OAC alone compared with 4,032 1. The primary endpoint showed a tutional Review Board. patients receiving OAC and APT higher prevalence of GI bleeding in therapy. Of these patients, 273 pa- patients on OAC with concomitant The primary objective was to com- tients in the OAC group and 292 APT agent(s); however, this differpare the percentage of patients patients in the OAC + APT group ence was not statistically significant experiencing a GI bleed on OAC were hospitalized for a GI bleed. (6.5% vs. 7.2%, P = 0.095). Of the alone versus OAC with at least one Overall, baseline characteristics patients receiving APT therapy, 243 APT agent. Secondary objectives were similar between the two patients (83.2%) were noted to be included comparing the percent- groups; however, more patients on inappropriate APT. Patients who age of patients with GI bleed who in the OAC group had a history of were inappropriately receiving APT were appropriately versus inap- GI bleed (49.1% vs. 37%). Most of with their OAC were significantly propriately receiving APT therapy the patient population was female more likely to experience a GI bleed in addition to OAC, and comparing (51.9%), and the mean age was than patients receiving appropriate the percentage of patients with similar between groups (71±12.8 vs APT (5.6% vs 7.7%, P = < 0.001). The GI bleed on OAC plus a single APT 72.8±9.9). Apixaban was the most most common reasons APT use was agent compared to triple therapy. commonly used anticoagulant in found to be inappropriate were for Appropriate APT therapy was de- both groups (72.5% vs. 73.3%), with CVD with no intervention (19.8%), fined by the 2020 ACC Expert Con- atrial fibrillation as the most fre- primary prevention in patients over sensus Decision Pathway for Anti- quent indication (59.7% vs. 64%). 60 years old (19.3%), and APT for coagulant and Antiplatelet Therapy Aspirin was the most widely used more than 1-3 months post-interin Patients with Atrial Fibrillation or APT agent within the OAC + APT vention in PAD or CVD (17.7%). No Venous Thromboembolism Under- group. Additional baseline charac- difference in the rate of GI bleeding going Percutaneous Coronary Intervention or with Atherosclerotic Table 1. Baseline Characteristics of Patients with GI Bleed OAC OAC + APT Characteristic Cardiovascular Disease. (10) (N = 273/4188) (N = 292/4032) Patients were identified from a computer-generated report that filtered for those hospitalized between January 1, 2022, and January 31, 2024, and on outpatient OAC with or without concomitant APT therapy. Patients were sorted for GI bleed based on ICD-10 codes (K92.2, K92.0, K92.1, K25.0, and I85.01), and the diagnosis was confirmed via chart review. All patients meeting the inclusion criteria were included in the analysis. A P-value of less than 0.05 was considered to indicate statistical significance.

All data analyses were conducted using Chi-Square analysis with JMP 17-PRO (SAS, Cary, NC).

Results A total of 8,220 patients were included in this study, with 4,188

Age – years (mean ± SD) Female – no. (%) Weight – kg (mean) History of anemia – no. (%) History of GI bleed – no. (%) PPI outpatient Concomitant medications increasing bleed risk – no. (%) NSAIDs – no. (%) SSRI/SNRI – no. (%) Oral anticoagulant Apixaban – no. (%) Rivaroxaban – no. (%) Warfarin – no. (%) Dabigatran – no. (%) Oral anticoagulant indication AF – no. (%) VTE – no. (%) Prosthetic heart valve – no. (%) LV thrombus – no. %) CCD/PAD – no. (%) Other/Unknown – no. (%) Antiplatelet agent Aspirin – no. (%) Clopidogrel – no. (%) Ticagrelor – no. (%) Prasugrel – no. (%) Antiplatelet indication ACS – no. (%) CCD/PAD – no. (%) Stroke/TIA – no. (%) Primary prevention – no. (%) Other – no. (%)

71 ± 12.8 158 (57.9) 82 211 (77.3) 134 (49.1) 136 (49.8) 75 (27.5) 15 (5.5) 60 (22)

72.8 ± 9.9 134 (45.9) 85.7 221 (75.7) 108 (37) 145 (49.7) 83 (28.4) 14 (4.8) 69 (23.6)

198 (72.5) 30 (11) 42 (15.4) 3 (1.1)

214 (73.3) 48 (16.4) 26 (8.9) 4 (1.4)

163 (59.7) 83 (30.4) 14 (5.1) 2 (0.7) 1 (0.4) 10 (3.7)

187 (64) 75 (25.7) 11 (3.8) 3 (1) 8 (2.7) 8 (2.7)

-

214 (73.3) 66 (22.6) 10 (3.4) 2 (0.7)

-

46 (15.8) 168 (57.5) 55 (18.8) 12 (4.1) 11 (3.8)

Abbreviations: Gastrointestinal (GI); Proton pump inhibitor (PPI); Non-steroidal anti-inflammatory drugs (NSAIDs); Selective serotonin reuptake inhibitor (SSRI); selective norepinephrine reuptake inhibitor (SNRI); Atrial fibrillation (AF); venous thromboembolism (VTE); left ventricular thrombus (LV thrombus); chronic coronary disease (CCD); peripheral artery disease (PAD); acute coronary syndrome (ACS); transient ischemic attack (TIA)

Page 22

was observed between patients taking OAC plus a single APT agent and those on triple therapy (7.4% vs 5.9%; P = 0.214). Results for the endpoints are shown in Table 2.

Table 2. Outcomes Primary Endpoint

Discussion

Patients with GI bleed on appropriate vs inappropriate antiplatelet agent(s) – no. (%)

Although the primary endpoint of this retrospective study did not show a statistically significant difference, our findings align with earlier studies showing that the combination of OAC and APT therapies can increase the risk of GI bleeding compared with OAC alone. (1-4, 7) Previous studies have demonstrated an increased risk of bleeding when direct oral anticoagulants (DOACs) are used concomitantly with APT agents; however, few have reported GI bleed as the primary endpoint. (17,18)

OAC (N=4188)

Patients experiencing a GI bleed – no. (%)

273 (6.5)

Secondary Endpoints

OAC + appropriate APT (N=883)

Patients with GI bleed on OAC + SAPT compared to triple therapy – no. (%)

OAC + APT (N=4032)

P-value

292 (7.2)

0.095

OAC + inappropriate APT (N=3149)

P-value

49 (5.6)

243 (7.7)

< 0.001

OAC + SAPT (N=3624)

Triple Therapy (N=408)

P-value

268 (7.4)

24 (5.9)

0.214

Abbreviations: oral anticoagulant (OAC); antiplatelet (APT); Gastrointestinal (GI); single antiplatelet (SAPT)

ria, the patient population in this study is more representative of real-world clinical scenarios in which the risks and benefits of OAC must be weighed, especially in the setting of APT therapies. Although patients in this study could receive any OAC, the majority were receiving a Factor Xa inhibitor, with apixaban (72.9%) and rivaroxaban (13.8%) accounting for most therapies. Since most of our study population were on apixaban, our study helps bridge Additionally, many of these studies a gap in the literature, given the evaluating bleeding rates excluded limited available evidence on the patients at increased risk of bleed- safety of Factor Xa inhibitors used ing (e.g., anemia, recent major concomitantly with APT agent(s) bleeds, thrombocytopenia). (17-19) in patients already at high risk of In our study, nearly half of the pa- GI bleed. However, further studies tients in the OAC group and 37% in are needed to better characterize the OAC plus APT group had a histo- the difference in safety outcomes ry of GI bleeding, and approximate- in this high-risk patient population. ly 75% of patients in both groups had a history of anemia. Potential As guidelines update, there is a conimpacts of the lack of difference in tinuing trend for promoting shorter the primary endpoint could include durations of APT therapies when a higher percentage of patients in patients are on concomitant OAC the OAC group with a history of to mitigate the risk of bleeding. (10GI bleed than in the OAC plus APT 12) This emphasis on shorter APT group. Additionally, almost half of durations likely contributed to the the patient population had back- overall low rate of GI bleeding obground use of a proton pump in- served in patients receiving triple hibitor (PPI). Although PPI use was therapy in this study. Fewer patients balanced between groups, this may were noted to be on triple therapy have contributed to the overall lack than on OAC plus SAPT, suggesting of difference in GI bleed prevalence shorter triple-therapy durations in between OAC and OAC plus APT. clinical practice. However, it is important to note that only 6 of the Given our broad inclusion crite- 24 patients (25%) on triple therapy Page 23

were on appropriate APT, indicating the need for continued education on appropriate antithrombotic use to mitigate the risk of GI bleeding further.

Given that 83.2% of patients with a GI bleed included in this study were deemed to be on inappropriate APT therapy, this highlights an opportunity for pharmacists to provide interdisciplinary education on prescribing and de-prescribing of APT agents in patients receiving OAC. In addition to providing education, pharmacist involvement in antithrombotic stewardship initiatives, such as protocol development and formal review processes, can help promote the appropriate utilization of APT agents.

De-prescribing APT therapies can help mitigate the risk of GI bleed, as inappropriate APT therapy was associated with a higher prevalence of GI bleed than appropriate APT therapy in this study. Previous studies have examined the appropriateness of APT therapies and found rates of inappropriate APT therapy ranging from 15.3% to 58.6%. (2023) In addition to assessing the appropriateness of APT therapies, some of these studies also evaluated the de-prescribing of inappropriate APT agents and found that successful pharmacist-led interventions to de-escalate APT therapies

varied from 30.3% to 93%. (20,21) The variability in successful interventions by pharmacists observed in these studies highlights the challenges of de-prescribing these agents, despite current literature and guideline recommendations.

(10-12, 20,21) Despite these challenges, pharmacists must be proactive in identifying patients at high risk of GI bleeding, assessing antithrombotic regimens, recommending appropriate deprescribing of APT agents, and providing provider education.

a collaborative, team-based approach and for reducing inappropriate APT prescribing and GI bleeds.

(14-16)

Medicine Clinical Specialist at Cape Fear Valley Medical Center. Riley Bowers, PharmD, is the Director of Assessment for the College of Pharmacy & Health Sciences and AssociThis study was inherently limited ate Professor of Pharmacy Practice by its retrospective design and the at Campbell University. inability to assess compliance with the prescribed antithrombotic regimen. Furthermore, the study did not account for patients deemed at References very high-risk for ischemic events 1. Wilkins T, Wheeler B, Carpenter M. who providers may choose to conUpper Gastrointestinal Bleeding tinue SAPT in addition to OAC. Subin Adults: Evaluation and Managesequent neurologic and cardiac ment. Am Fam Physician. 2020 Mar events were also not collected to 1;101(5):294-300. Erratum in: Am The percentage of patients on in- determine whether the benefit perFam Physician. 2021 Jan 15;103(2):70.

PMID: 32109037. appropriate APT therapy was high- sisted with continued use of these 2.

Hao W, Liu A, Zhu H, et al. Risk factors er in our study compared to the medications in patients lacking inand management of gastrointestinal above-mentioned studies. (20-23) dications. Lastly, the use of overbleeding in patients with or without This could be attributed to differ- the-counter NSAIDs may have been antiplatelet and anticoagulation therences in patient population, phar- underreported and could have conapy: a multicenter real-world promacist and provider training, and tributed to the rates of GI bleeding spective study. BMC Gastroenterol. the influence of healthcare silos. in both the OAC and OAC plus APT 2024 May 7;24(1):155. doi: 10.1186/ Healthcare silos are defined as groups. s12876-024-03238-3.

PMID: physical and non-physical barriers 38714955; PMCID: PMC11077848. that may arise in the health sys- Conclusion 3. Hawks MK, Svarverud JE. Acute Lowtem. (14) Examples of healthcare er Gastrointestinal Bleeding: Evaluation and Management. Am Fam Physilos can include specialty consult There was an increased prevalence sician. 2020 Feb 15;101(4):206-212. services, poor communication be- of GI bleed in patients on OAC plus PMID: 32053333. tween members of the healthcare APT, with most patients in this 4.

He Y, Wong IC, Li X, et al. The associateam, and the inability to share group being candidates for de-pretion between non-vitamin K antagodata due to differences in electron- scribing. Despite guideline recomnist oral anticoagulants and gastroinic health records. (14,16) Consult mendations, the de-prescribing of testinal bleeding: a meta-analysis of services such as cardiology, vascu- APT agents remains a clinical chalobservational studies. Br J Clin Pharlar surgery, and neurology are often lenge. This creates an opportunity macol. 2016 Jul;82(1):285-300. doi: involved in patients represented in for pharmacists to play a vital role 10.1111/bcp.12911. Epub 2016 our study, which can pose challeng- in antithrombotic stewardship and Apr 15. PMID: 26889922; PMCID: PMC4917795. es for the appropriate prescribing targeted education to improve proof APT therapies. This siloed men- vider awareness and reduce the im- 5. Barada K, Abdul-Baki H, El Hajj II, et al. Gastrointestinal bleeding in the tality, however, is not limited to pact of healthcare silos on patient setting of anticoagulation and antispecialty services and can be seen care. platelet therapy. J Clin Gastroenterol. in primary care, where providers 2009 Jan;43(1):5-12. doi: 10.1097/ are more hesitant to make thera- Authors: Ruby A. Odum, PharmD MCG.0b013e31811edd13.

PMID: peutic adjustments to antithrom- is an Internal Medicine Clinical Spe18607297. botic therapies when consult ser- cialist at Erlanger. raodum0908@ 6. Tielleman T, Bujanda D, Cryer B. Epvices are involved. Addressing and email.campbell.edu. Carrie Baker, idemiology and Risk Factors for Upovercoming this siloed mentality in PharmD, MBA, is a Clinical Assistant per Gastrointestinal Bleeding. Gashealthcare is important for provid- Professor of Pharmacy Practice at trointest Endosc Clin N Am. 2015 Jul;25(3):415-28. doi: 10.1016/j. ing patient-centered care through Campbell University and Internal Page 24

giec.2015.02.010. PMID: 26142028.

7. Hallas J, Dall M, Andries A, et al. Use of single and combined antithrombotic therapy and risk of serious upper gastrointestinal bleeding: population-based case-control study.

BMJ. 2006 Oct 7;333(7571):726. doi: 10.1136/bmj.38947.697558.AE. Epub 2006 Sep 19. PMID: 16984924; PMCID: PMC1592384.

8. Turpie AG, Gent M, Laupacis A, et al.

A comparison of aspirin with placebo in patients treated with warfarin after heart-valve replacement. N Engl J Med. 1993 Aug 19;329(8):524-9. doi: 10.1056/NEJM199308193290802.

PMID: 8336751.

9. Eikelboom JW, Wallentin L, Connolly SJ, et al. Risk of bleeding with 2 doses of dabigatran compared with warfarin in older and younger patients with atrial fibrillation: an analysis of the randomized evaluation of long-term anticoagulant therapy (RE-LY) trial. Circulation. 2011 May 31;123(21):2363-72. doi: 10.1161/ CIRCULATIONAHA.110.004747. Epub 2011 May 16. PMID: 21576658.

10. Kumbhani DJ, Cannon CP, Beavers CJ, et al. 2020 ACC Expert Consensus Decision Pathway for Anticoagulant and Antiplatelet Therapy in Patients With Atrial Fibrillation or Venous Thromboembolism Undergoing Percutaneous Coronary Intervention or With Atherosclerotic Cardiovascular Disease: A Report of the American College of Cardiology Solution Set Oversight Committee. J Am Coll Cardiol. 2021 Feb 9;77(5):629-658. doi: 10.1016/j.jacc.2020.09.011. Epub 2020 Nov 26. PMID: 33250267.

11. Virani SS, Newby LK, Arnold SV, et al.

Peer Review Committee Members.

2023 AHA/ACC/ACCP/ASPC/NLA/ PCNA Guideline for the Management of Patients With Chronic Coronary Disease: A Report of the American Heart Association/American College of Cardiology Joint Committee on Clinical Practice Guidelines. Circulation.

2023 Aug 29;148(9):e9-e119. doi: 10.1161/CIR.0000000000001168.

Epub 2023 Jul 20.

12. Rao SV, O’Donoghue ML, Ruel M, et al. 2025 ACC/AHA/ACEP/NAEMSP/ SCAI Guideline for the Management of Patients With Acute Coronary Syndromes: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2025 Feb 27. doi: 10.1161/ CIR.0000000000001309. Epub ahead of print. PMID: 40014670.

13. Lopes RD, Hong H, Harskamp RE, et al. Optimal Antithrombotic Regimens for Patients With Atrial Fibrillation Undergoing Percutaneous Coronary Intervention: An Updated Network Meta-analysis. JAMA Cardiol. 2020 May 1;5(5):582-589. doi: 10.1001/ jamacardio.2019.6175.

PMID: 32101251; PMCID: PMC7240352.

14. Peiris D, Feyer AM, Barnard J, et al.

Overcoming silos in health care systems through meso-level organizations - a case study of health reforms in New South Wales, Australia. Lancet Reg Health West Pac. 2024 Feb 15;44:101013. doi: 10.1016/j.lanwpc.2024.101013. PMID: 38384947; PMCID: PMC10879775.

15. Lau RS, Boesen ME, Richer L, et al.

Siloed mentality, health system suboptimization and the healthcare symphony: a Canadian perspective. Health Res Policy Syst. 2024 Jul 17;22(1):87. doi: 10.1186/s12961024-01168-w. PMID: 39020412; PMCID: PMC11253392.

16. Bondurant LM. Breaking Down Silos: Interprofessional Collaborative Practice in Humanitarian Audiology.

Semin Hear. 2020 May;41(2):92-99. doi: 10.1055/s-0040-1708506. Epub 2020 Apr 7. PMID: 32269413; PMCID: PMC7138634.

17. Douros A, Renoux C, Yin H, et al. Concomitant Use of Direct Oral Anticoagulants with Antiplatelet Agents and the Risk of Major Bleeding in Patients with Nonvalvular Atrial Fibrillation.

Am J Med. 2019 Feb;132(2):191199.e12. doi: 10.1016/j.amjmed.2018.10.008. Epub 2018 Oct 25. PMID: 30691551.

18. Oldgren J, Wallentin L, Alexander Page 25

JH, et al. New oral anticoagulants in addition to single or dual antiplatelet therapy after an acute coronary syndrome: a systematic review and meta-analysis. Eur Heart J. 2013 Jun;34(22):1670-80. doi: 10.1093/ eurheartj/eht049.

Epub 2013 Mar 6. PMID: 23470494; PMCID: PMC3675388.

19. Holster IL, Valkhoff VE, Kuipers EJ, et al. New oral anticoagulants increase risk for gastrointestinal bleeding: a systematic review and meta-analysis.

Gastroenterology.

2013 Jul;145(1):105-112.e15. doi: 10.1053/j.gastro.2013.02.041. Epub 2013 Mar 5. PMID: 23470618.

20. Zekery-Saad SA, Lewin A, Pham M, et al. Evaluation and optimization of prescribed concomitant antiplatelet and anticoagulation therapy centrally managed by an anticoagulation management service. J Thromb Thrombolysis. 2021 Feb;51(2):405-412. doi: 10.1007/s11239-020-02207-3.

PMID: 32651889.

21. Meador S, Dyke S, Togami J, et al.

Antithrombosis stewardship efforts to de-escalate inappropriate combined therapy in outpatient clinics. J Thromb Thrombolysis. 2022 Feb;53(2):436-445. doi: 10.1007/ s11239-021-02551-y. Epub 2021 Aug 19. PMID: 34410560.

22. Ardoino I, Rossio R, Di Blanca D, et al. Appropriateness of antiplatelet therapy for primary and secondary cardio- and cerebrovascular prevention in acutely hospitalized older people. Br J Clin Pharmacol. 2017 Nov;83(11):2528-2540. doi: 10.1111/ bcp.13355. Epub 2017 Aug 1. PMID: 28722184; PMCID: PMC5651307.

23. Naveed H, Akhtar N, Al-Jerdi S, et al.

Appropriate use of antiplatelet medications following transient ischemic attacks and stroke: a 9-year study from the Middle East. Front Neurol. 2023 Nov 9;14:1269292. doi: 10.3389/fneur.2023.1269292. PMID: 38020628; PMCID: PMC10666165.

Blujepa (gepotidacin) By: Brittany Caskey, PharmD Candidate 2026, and Mara Morley, PharmD Candidate 2027 Abstract

a promising oral alternative for the management of uUTIs, particularObjective: To review the pharma- ly in patients with limited options cology, clinical efficacy, safety, and due to resistance or intolerance to potential place in therapy of gep- standard therapies. While cost conotidacin, a novel triaza-acenaphth- siderations may initially limit use, ylene antibiotic recently approved gepotidacin may play an important by the FDA for the treatment of un- role as resistance to conventional complicated urinary tract infections antibiotics continues to rise. (uUTIs).

Data Sources: Primary literature, including phase 3 clinical trials (EAGLE-2 and EAGLE-3), prescribing information, and authoritative drug information databases such as Lexicomp and Micromedex, were reviewed.

Summary: Gepotidacin is the firstin-class oral antibiotic that inhibits bacterial DNA replication through novel topoisomerase inhibition.

Clinical trials demonstrated non-inferiority and, in some cases, superiority to nitrofurantoin in treating uUTIs, with a favorable safety profile. Common adverse events included gastrointestinal disturbances, while serious but uncommon risks included QT prolongation. Gepotidacin offers an important new oral option, particularly against resistant uropathogens.

Introduction Antimicrobial resistance continues to erode the effectiveness of cornerstone antibiotics, creating an urgent need for innovative therapies.

Urinary tract infections (UTIs), one of the most common bacterial infections encountered in outpatient practice, highlight this challenge as resistance among Escherichia coli and other uropathogens steadily rises. First-line agents such as nitrofurantoin remain reliable, but their utility is threatened by evolving resistance patterns and limited options for patients who cannot tolerate or fail traditional therapies. (1) In this landscape, new antibiotics with novel mechanisms of action are essential to sustain effective treatment strategies.

March 2025, is the first in a new class of triaza-acenaphthylene antibiotics with a distinct mechanism targeting bacterial type II topoisomerases. (2,3) Unlike fluoroquinolones, gepotidacin binds at a unique site on DNA gyrase and topoisomerase IV, allowing it to retain activity against strains resistant to commonly used antimicrobials.

This novel mechanism not only broadens coverage but also reduces the likelihood of cross-resistance with existing drug classes. With oral bioavailability, activity against multidrug-resistant organisms, and potential application in both urogenital and respiratory infections, gepotidacin represents a significant advancement in the antibiotic pipeline.

FDA-Approved Indication

Gepotidacin is indicated for the treatment of uncomplicated urinary tract infections (uUTIs) in female adults and pediatric patients (≥ 12 years and ≥ 40 kg) caused by susceptible strains of Escherichia coli, Klebsiella pneumoniae, Citrobacter freundii complex, Staphylococcus saprophyticus, and Enterococcus faecalis. (2) Its use should Gepotidacin, developed by be limited to proven or strongly Conclusion: Gepotidacin provides GlaxoSmithKline and approved in suspected infections to reduce the Page 27

development of resistance.

Laboratory confirmation included evidence of infection with either Pharmacology and Pharmacoki- nitrite positivity, pyuria (>15 WBC netics per high-power field), or both. (4) Exclusion criteria were stringent to Gepotidacin inhibits bacterial DNA minimize confounding and included replication by targeting type II to- complicated or upper tract infecpoisomerases, including DNA gy- tions, anatomical anomalies predisrase and topoisomerase IV. (2,3) posing to recurrence, uncontrolled This mechanism of action is dis- diabetes, and impaired renal functinct from that of fluoroquinolones, tion (CrCl <60 mL/min). (4) thereby limiting cross-resistance.

Following oral administration, gep- Patients were randomized 1:1 to otidacin demonstrates an absolute gepotidacin 1500 mg orally twice bioavailability of approximately daily for 5 days or nitrofurantoin 45%, with peak plasma concentra- 100 mg orally twice daily for 5 days, tions reached within two hours. Dis- each accompanied by a placebo tribution is extensive, with 25–41% to preserve blinding. Treatment protein binding. (2) The drug un- was administered approximately dergoes oxidative metabolism pri- every 12 hours with food and wamarily via CYP3A4 to form its major ter, and adherence was monitored metabolite, M4. Elimination oc- during scheduled visits. The primacurs through both renal and fecal ry endpoint was therapeutic sucroutes, with 31% recovered in the cess, defined as complete sympurine (20% as unchanged drug) and tom resolution plus microbiological 52% in the feces (30% unchanged). eradication (<10³ CFU/mL from a Steady-state concentrations are baseline ≥10⁵ CFU/mL) at test-ofachieved within three days of cure (day 10–13). The study used twice-daily dosing. (2,3) a 10% non-inferiority margin. Patients requiring additional systemic Clinical Efficacy antibiotics or missing follow-up cultures were considered treatment The EAGLE-2 and EAGLE-3 phase failures. Secondary outcomes in3 trials, published in The Lancet in cluded sustained response at fol2024, directly compared oral gep- low-up, recurrence rates, and the otidacin with nitrofurantoin for the need for additional antibiotic thertreatment of uUTIs in adolescent apy. (4) and adult women. Both EAGLE-2 and EAGLE-3 were randomized, In total, 1,531 patients were ranmulticenter, double-blind, dou- domized in EAGLE-2 and 1,605 in ble-dummy, non-inferiority trials EAGLE-3. (4) Interim analyses, guidin which patients were enrolled ed by alpha-spending functions and at 219 global sites, totaling 3,136 Pocock/O’Brien-Fleming boundarpatients. (4) Eligible patients were ies, led to early termination of both non-pregnant females aged ≥12 trials for efficacy. At test-of-cure, years, weighing ≥40 kg, and pre- gepotidacin met non-inferiority crisenting with at least two urinary teria compared with nitrofurantoin. symptoms (dysuria, urgency, fre- In EAGLE-2, the number needed to quency, or lower abdominal pain) treat (NNT) for therapeutic success within 96 hours of enrollment. with gepotidacin versus nitrofuranPage 28

toin was 28, while in EAGLE-3, the NNT was as low as 7, indicating a clinically meaningful benefit in certain populations. Conversely, the number needed to harm (NNH) for therapeutic failure was 27 in EAGLE-2 and 6 in EAGLE-3, highlighting variability between the two trials but reinforcing the consistent overall efficacy profile. Subgroup analyses further demonstrated gepotidacin’s robustness across patient categories, including those with recurrent uUTIs, multidrug-resistant organisms, and fluoroquinolone-resistant strains.

Safety outcomes revealed that treatment-emergent adverse events were more common with gepotidacin but were generally mild to moderate, most frequently gastrointestinal (diarrhea, nausea, vomiting). Adverse events led to treatment discontinuation in approximately 5% of patients in both trials. By contrast, nitrofurantoin was associated with fewer systemic side effects but also carried its own risk of intolerance and was less effective against resistant strains. No new or unexpected safety signals emerged with gepotidacin, supporting its viability as an oral outpatient therapy.

Safety and Tolerability Overall, the results of EAGLE-2 and EAGLE-3 support gepotidacin as a non-inferior, and in some analyses potentially superior, oral therapy for uUTIs in women. Its demonstrated activity against resistant pathogens positions it as a valuable addition to the antimicrobial armamentarium at a time when treatment options are under pressure.

While further data are warranted in broader populations—includ-

ing men, pregnant patients, and patients with complicated infections—the findings suggest that gepotidacin may play an important role as either a first-line or alternative therapy for uUTIs, especially in the setting of rising nitrofurantoin resistance. (4) Additionally, gepotidacin was well-tolerated in clinical trials. The most frequently reported adverse events were gastrointestinal, including diarrhea (16%), nausea (9%), abdominal pain (4%), and flatulence (3%). (4) More serious risks include prolongation of the QT interval and hypersensitivity reactions, although no fatal events were observed in clinical development. The tolerability profile supports its use as a viable oral option for uUTI treatment.

Drug Interactions Coadministration with strong CYP3A4 inducers may reduce gepotidacin concentrations and should be avoided. (3) Similarly, use with narrow therapeutic index CYP3A4 substrates may increase substrate exposure and is contraindicated.

Gepotidacin has the potential to prolong the QT interval; concurrent use with other QT-prolonging agents should be approached with caution and close monitoring. (3) Additionally, gepotidacin may increase digoxin concentrations, necessitating serum monitoring. The manufacturer warns that concomitant administration with acetylcholinesterase inhibitors may cause dysarthria and other adverse effects. (3) Use in Special Populations There is limited data regarding using gepotidacin in pregnancy.

Animal studies demonstrated de-

creased fetal weight and increased resorptions at clinically relevant exposures, though no malformations were observed. (2) Gepotidacin’s use in pregnancy should therefore be reserved for situations where the benefit outweighs the risk. The excretion of gepotidacin into human milk is unknown, and caution should be exercised in lactating patients.

Gepotidacin represents a valuable addition to the therapeutic armamentarium for the treatment of uUTIs. It should be considered an alternative oral option in patients with resistant infections or intolerance to standard therapies. While cost may limit initial widespread adoption, gepotidacin’s clinical utility lies in its role as a second-line or alternative first-line option in setDosing and Administration tings of resistance. As antimicrobial resistance continues to rise, gepThe recommended dosage of gep- otidacin may become an important otidacin for uUTIs is 1500 mg (two component of guideline-recom750 mg tablets) orally every 12 mended therapy. hours with food for five days. This medication should be avoided in Authors: Brittany Caskey, PharmD patients with an estimated creat- Candidate 2026 (b_termeer0403@ inine clearance < 30mL/min. (2,3) email.campbell.edu) and Mara The drug should be stored at con- Morley, PharmD Candidate 2027; trolled room temperature. The cost Campbell University College of of a five-day course can exceed $ Pharmacy & Health Sciences.

1,500.00, but the manufacturer offers a savings coupon at www.blujepa.com. (2,3,6) Comparative Effectiveness First-line oral treatments for uUTIs include nitrofurantoin, trimethoprim-sulfamethoxazole, fosfomycin, and pivmecillinam. Each of these agents faces challenges related to resistance, tolerability, or safety concerns. Fluoroquinolones, while effective, are reserved due to well-documented safety risks and concerns for resistance. (5) Gepotidacin, with its novel mechanism of action, offers a critical advantage in cases involving resistant uropathogens. Clinical trial results suggest that gepotidacin is as effective as, or more effective than, nitrofurantoin while maintaining an acceptable safety profile. (5) Place in Therapy Page 29

References 1. Larkin C, Valappil SP, Palanisamy N. Global prevalence of nitrofurantoin-resistant uropathogenic Escherichia coli (UPEC) in humans: a systematic review and meta-analysis. J Antimicrob Chemother. 2025; dkaf305. doi:10.1093/jac/dkaf305 2. Lexi-Drugs. Gepotidacin. Hudson, OH: Lexicomp, 2025.

3. Blujepa (gepotidacin) [prescribing information]. Durham, NC: GSK; March 2025.

4. Wagenlehner F, Perry CR, Hooton TM, et al. Lancet.

2024;403(10428):741-755.

5. Micromedex Solutions. Gepotidacin. Greenwood Village, CO: Truven Health Analytics; 2025.

6. Blujepa (gepotidacin). Available at: https://www.goodrx.com/blujepa/what-is. Accessed 11/24/2025.

NCAP Holiday Closure & NC MPJE Book Orders

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September 20, 2026 – Pharmacy Professionals’ Wellbeing October 18, 2026 – Breaking Bad with Street Smarts: Drug Edition November 15, 2026 – Keep Your Brain in the Game: Preventing Meningococcal Disease December 13, 2026 – Premium Fuel: Harnessing the Power of Nutrition with GLP-1 Therapies

The NCAP staff would like to wish you all a very happy, • restful holiday season. Our office will be closed from Tuesday, December 23, 2025 through Friday, January • 2, 2026. During this time, NC MPJE book and online course orders, will be processed on Tuesdays and • Thursdays. If you would like to be sure you have the materials to study during the break, please place your New Practitioner Forum Chat Box orders with those days in mind, by visiting the NCAP NC MPJE webpage.

New Practitioner Forum has a Mentorship Chat Box called “ Ask a New Practitioner” for any student (or Sunday Evening Webinars anyone seeking additional guidance) to ask questions The Sunday Evening Webinar Series presented a vari- and get connected with a mentor. ety of topics throughout 2025. We are very excited to Sign Up: Ask the New Practitioner Forum unveil our list of topics for 2026. Titles and speakers for many of the topics are still being confirmed; howSave the Date! ever, please see the dates and topics below and mark NCAP’s 2026 Annual Convention your calendars for another year of learning. Webinars are ACPE accredited for 1 hour of live CE for pharmaMark your calendars and plan to attend the 2026 cists and pharmacy technicians.

NCAP Annual Convention, May 31 – June 2, 2026, in • January 18, 2026 – Navigating Vaccine Procure- Cary, NC at the Embassy Suites Research Triangle. The planning committee is working to create content you ment Hurdles • February 15, 2026 – Anticoagulants in Older Adults won’t want to miss. The annual convention is the per• March 15, 2026 – “The Times They Are a Changin’”: fect place to hang out with old friends, make new ones, and cultivate lasting professional connections with NC The Path to Full Practice Authority pharmacy professionals from all areas of practice. Ask • April 19, 2026 – Using Food as Medicine • May 17, 2026 – Pharmacy History and What the for the time off now; you don’t want to hear later about Passage of Time Teaches Us what a great event it was, and have to say, “I wish I had • June ?, 2026 – No Webinar; Convention Month been there”.

• July 19, 2026 – Unlock the Power of Collaborative Practice Don’t miss an NCAP event! Check out our full calendar at ncpharmacists.org.

• August 16, 2026 – Transformers: Rise of Practice Heroes and Their Success Stories Page 30

Meet NCAP’s Newest Team Member Hello NCAP community!

deeply. My hope is to help NCAP feel like a place where you’re not only informed but genuinely seen, valued, and connected.

My name is Amanda Warren, and A Little About Me I’m excited to introduce myself as NCAP’s new Membership Devel- I have lived in Burlington with my opment Coordinator — or, as I’ve husband for almost nine years. We proudly self-proclaimed it, MDC. have a spirited 4-year-old daughter, Addilyn, and our 11-year-old From my first conversations with boxer/lab mix, Charlie. I’ve called NCAP staff, several board mem- Burlington home since sixth bers, and the students I met at the grade, though I was born in VirNCAP Residency Showcase, one ginia Beach. thing immediately stood out: this is a community built on passion, I love to travel (I made it to Europe dedication, and genuine heart. in 2019 before COVID — take me Pharmacists and pharmacy tech- back to Paris for the food and Ennicians across North Carolina are gland for the cask beer), bake and doing incredible work every sin- decorate cakes (ask about the spigle day — and one of my goals is der cupcake cake or the sunshine to help make the membership ex- cupcakes!), craft (yes… I made our perience feel more personal, more pink glittery spider costumes), I connected, and sprinkled with my love the beach and nature, and I’m natural spark for warmth and fun. a former sprint triathlete turned triathlon race director.

My background — professionally and in volunteer work — has always centered around people, communication, and relationship-building. I strongly believe in the power of meaningful conversation, storytelling, and bringing humanity into the work we do. I’ve never met a stranger. I’m an open book who wants to learn who you are, what you do, and how we can make your professional life easier, better, and more supported.

Whether you’re a pharmacy technician, a community pharmacist, a health-system leader, in ambulatory or chronic care, a student, or just beginning your career, I want to understand what your days look like and what support makes the biggest difference.

Every role in pharmacy matters

Before joining NCAP, I worked part-time as a church administrator, spent a few years as a SAHM (stay-at-home mom), and before that worked as a bank marketing coordinator. There were also chapters in commercial lending, retail banking management, and even restaurant management — but that’s a story for another journal or even a book.

My family is a huge part of why I show up wholeheartedly in this work. I’ve included a few photos so you can get a glimpse into my world — and you’ll likely hear plenty of stories. A close friend once told me: “Amanda, you’ve done more in one lifetime than many do in two.”

It stuck with me as very fitting for my life so far, and I have so many more years to go (God willing).

What’s Ahead

Over the next month, my focus is on learning about our systems, connecting with staff and board members, and understanding how everything fits together so I can support our membership efforts well.

I am a proud graduate of UNCG, which I went back to in 2019 to finish my bachelor’s degree, and I graduated when the little one was about a month old. I wanted to teach her to finish things she started, and that it was never too late to do so!

As we head into early 2026, I’ll be Page 31

working closely with Dr. Shelton, the board, and our team to strategize, strengthen communication touchpoints, and make engagement with NCAP easier and more meaningful. Listening deeply is my first priority — to students, techs, new practitioners, longtime leaders, corporate leaders, and our independent community.

NCAP journey.

I look forward to meeting you soon!

Amanda Warren

Fun Facts About Me:

• Some of you I’ve already had the pleasure of meeting, and I look forward to meeting many more of • you in the new year.

• Thank you for the incredibly warm welcome already. I’m excited to get to know you, hear your stories, and support you in your

• • •

I thrive on organized chaos • and love bringing people together.

I have five tattoos; each tied to a different season in my life.

I’m currently planning a wom- • en’s Christmas Cookie Exchange at my church - and yes, it mainly was for the cookies I get to take home.

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I secretly like Bluey more than my kid does — and I’m not even sorry.

I thrive on Celsius, morning devotionals, and comfy blankets— my daily survival kit.

I will gladly sing and dance with no shame, zero training, and a whole lot of laughter.

I’m an extra extrovert who embraces being extremely human — imperfect, wholehearted, and always ready to connect.

My favorite quote: “Be the change you want to see in the world.” Mahatma Gandhi

Calling All Community Pharmacies

Join NCAP’s 2025–2026 Governor’s Institute Grant Initiatives!

3. Long-Acting Injectable (LAI) Administration for Opioid Use Disorder (OUD)

For more than six years, the North Carolina Association of Pharmacists (NCAP) has proudly partnered with the Governor’s Institute to advance the prevention, treatment, and recovery of substance use disorders through pharmacy-based intervention.

New for 2025–2026! NCAP is seeking two community pharmacies to pilot pharmacy-based long-acting injectable (LAI) services for patients with substance use disorders. This model fosters collaboration between community OUD prescribers, pharmacists, and their shared patients to improve access, adherence, and outcomes.

Each year, we look to pharmacists like you—leaders at the frontlines of patient care—to help strengthen our profession’s role as a cornerstone in the fight against opioid overdose.

We are now recruiting community pharmacies to participate in the 2025–2026 Governor’s Institute Grant Initiatives.

This year’s opportunities include: 1. Opioid Stewardship Advanced Pharmacy Practice Elective - Are you passionate about student engagement and opioid safety?

- Each year, NCAP seeks innovative community pharmacies to host 4th-year pharmacy students completing an Opioid Stewardship Elective.

- For 2025–2026, we are especially seeking pharmacies interested in utilizing a student to help implement or expand Naloxone Services within their practice.

Why LAI Buprenorphine?

Research shows that patients receiving LAI buprenorphine for SUD stay in treatment longer and achieve better outcomes. A meta-analysis of 18 studies found LAI buprenorphine is associated with improved abstinence rates and higher patient satisfaction compared to transmucosal formulations, with no significant safety concerns.

Despite these benefits, LAI medications are often underutilized because prescribers lack the ability to administer them and ensure patients receive treatment. LAI administration, particularly for buprenorphine, addresses common barriers, including wholesaler acquisition challenges. These products are also not subject to SORS (Suspicious Orders Report System) reporting, as they pose no abuse potential because they are never dispensed directly to patients.

Why this pilot matters: 💰Pharmacies can earn $500 for participation. connecting OUD prescribers with LAI-administering 👉[Click here] to express your interest and receive more Bypharmacies, we can expand access to life-saving treatinformation.

ment and support sustained recovery for patients in need.

2. Syringe Service Program (SSP) Partnerships NCAP is actively recruiting pharmacies interested in partnering with local Syringe Service Programs (SSPs) to expand harm reduction services in their communities.

Participating pharmacies will collaborate with an SSP to provide safe-use supplies, education, resources, and life-saving support to patients in need.

💰Pharmacies can earn up to $1,500 for participation. 📨 To get started, contact cheryl@ncpharmacists.org 🔎For a glimpse at the success of this initiative over the

years, check out NCAP’s Poster presented at the Convention this past June!

To learn more about SSP/Pharmacy Collaborative, visit NCAP’s Syringe Service Program & Pharmacy Toolkit.

📖

Participating pharmacies will: • Be (or be willing to become) REMS-certified to order, dispense, and administer Sublocade and Brixadi • Establish collaborative relationships with one or more OUD treatment providers • Deliver integrated, patient-centered care that supports recovery and continuity of treatment.

💰Pharmacies can earn up to $4,000 for participation. 📨Interested? Contact Cheryl Viracola at cheryl@ncpharmacists.org for details.

Together, we can continue building pharmacy’s impact in North Carolina’s response to substance use disorder—one patient, one pharmacy, one community at a time.

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been envisioned to commemorate NCAP’s twenty-five years of unification than the culmination of the annual convention with the passing of these two key pieces of legislation.

NCAP is also expanding our grassroots advocacy work with pharmacy professionals in all practice settings. Information is key, and NCAP has reorganized our website’s government affairs webpages to help inform but also to help facilitate engagement on issues important to our profession and patients. In addition, we are conducting more direct outreach to independently owned pharmacies.

Recognizing the vital role that independent pharmacies serve in their communities, as well as how this sector of our profession has been particularly vulnerable to federal policies and pharmacy benefit manager practices, which impact reimbursement, NCAP has reenviThis year, NCAP led essential, practice-transforming sioned and rebranded the Association’s Independent legislation and partnered with pharmacy stakeholders Pharmacy Network. In 2026, we will move this entity to achieve the passage of multiple pharmacy-related forward as the rebranded Independent Pharmacy Probills, including test-and-treat authority, collaborative fessionals group, and we will be rolling out a newly depractice expansion, payment for services, and PBM re- veloped portfolio of resources designed to help indeform. pendent pharmacies thrive.

NCAP Advancing Pharmacy Advocacy: Our 2025 Progress and Support

There were two moments when the strength of our advocacy efforts was especially palpable. The first occurred during our annual Legislative Day, when pharmacy professionals’ excitement and energy flowed throughout the halls of the legislative buildings, and our test-and-treat bill was received favorably, passing in a Senate Health Committee Hearing that same day. The next high point occurred during the NCAP Annual Convention when conventioneers were asked to advocate by calling their Representative to ask for their vote to support the Senate version of H67. Convention attendees were able to influence policy in real time and subsequently celebrate together, that very evening, the passing of H67, a healthcare omnibus bill, which contained provisions requiring payment for pharmacist-provided services, test and treat authority, medication administration authority, and collaborative practice expansion. (1)

In 2025, our lobbyists were active, serving as dedicated advocates for pharmacy-related legislation and ensuring that the needs of pharmacy professionals are well represented in healthcare policy discussions.

Many of the activities and progress our association made were supported in part by the funding NCAP received in 2025 from the McKesson Amplify program.

Complete details about the mission of McKesson’s industry-leading pharmacy advocacy support program are available on the McKesson Amplify website. And we’re ready to keep the momentum going. We are excited to announce that NCAP recently learned we were approved to receive funding from the 2026 McKesson Amplify program for the coming year. Our plan for utilizing funding in 2026 will center around the preparation for legislation on standard of care and full practice authority.

As the 2025 NCAP Convention was wrapping up and Thank you to all members who have engaged, spoken most conventioneers were on their way home, NCAP up, and supported NCAP’s advocacy work—your voicreceived word that the House would be voting on es are driving real change for our profession. the PBM reform bill, and on June 26th, the Script Act (S479) was passed. (2) No finer hallmark could have Page 34

References 1. House Bill 67 / SL 2025-37 (2025-2026 session) - North Carolina General Assembly. ncleg.gov. Accessed November 26, 2025. https://www.ncleg.gov/BillLookup/2025/ H67.

2. Senate Bill 479 / SL 2025-69 (2025-2026 session) North Carolina General Assembly. ncleg.gov. Accessed November 26, 2025. https://www.ncleg.gov/BillLookup/2025/S479.

3. McKesson Amplify. McKesson. Accessed November 26, 2025. https://www.mckesson.com/commitments/public-policy/mckesson-amplify/.

(Photos courtesy of Rhonda Horner-Davis and an article published by WUNC)

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2025

ACADEMY YEAR END SUMMARIES NCAP has a variety of online groups to help support the special interests of our members. 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.

AMBULATORY CARE PRACTICE ACADEMY The Ambulatory Care Practice Academy maintained a strong focus on professional advocacy, education, and membership engagement throughout 2025, operating under the leadership of Chair Glenn Herrington, Chairelect Ben Smith, and Past-Chair Mackie King. The Academy's activities were directly aligned with NCAP’s strategic goals, focusing on advancing the profession through stakeholder engagement and educational activities.

A significant focus for the Academy and NCAP this year was legislative advocacy aimed at advancing the pharmacy profession. Key legislative developments included the passing of House Bill 67, which was signed into law by Governor Josh Stein on July 1st. This crucial legislation reforms the scope of Clinical Pharmacist Practitioners, enhancing their ability to provide health care services through collaborative Page 36

agreements. The Academy thanks Senator Sawrey, the Board of Pharmacy, and all the NCAP members and staff for their efforts in supporting this milestone achievement.

The Academy focused on utilizing virtual, live, and written programming to meet the educational needs of its membership.

The Academy established the "Ambulatory Care Monthly Huddle," a virtual meeting held on the fourth Friday of every month at 12pm. These meetings are designed to support open dialogue and facilitate the sharing of ideas and solutions for common ambulatory care matters. Each huddle begins with a "pearls session" or clinical case before moving to open dialogue, and colleagues who are not NCAP members are invited to attend.

Some highlighted topics covered included artificial intelligence, pharmacy technicians, collaborative practice updates,

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and hypertension guideline updates.

The Academy contributed significantly to the Annual Convention, held in Asheville, NC, from June 23-25. The convention theme was "Prioritizing Public Health: Joining Forces Across Academies for a Healthier NC".

The Academy sponsored two key sessions: "Value-Based Care and Its Connection to Population Health" presented by Ben Smith and Lisa Padgett, and "CardioKidney-Metabolic Management" presented by Anita Yang and Carrie Baker.

The Academy supported submissions to the NCAP Journal as well. Two members, Shawn Taylor and Katelyn Hernandez, had publications accepted.

In recognition of professional excellence, the Academy selected Monica Dillingham as the Ambulatory Care Pharmacist of the Year. It was fitting to recognize her outstanding efforts in coordinating care for the western North Carolina Community following Hurricane Helen at the annual convention in Asheville.

While the Academy achieved several major milestones, the leadership team identified some ongoing and future strategic Page 37

objectives for 2026, many of which align with NCAP's goal to ensure sustainability and relevance through membership and optimal governance. Key initiatives include the immediate need to recruit candidates for atlarge and leadership roles, increasing engagement of students and residents through social media and other platforms, and continuing to grow the monthly huddles.

The Academy’s commitment to advocacy, education, and internal growth reinforces its vital role in advancing the practice of ambulatory care pharmacy, and we look forward to achieving more milestones in 2026!

CHRONIC CARE ACADEMY The NCAP Chronic Care Practice Academy (CCPA) has had a wonderful year! The leadership team consisted of the following individuals: Aparna Krishnamurthy – Chair Tasha Woodall – Chair Elect Kimberly Hayashi – Past Chair The following individuals have also graciously served their time as members at large: Emma Williams Haley Webster Caroline Garvey

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Kira Durr Stephanie Vermillion Kali Hollingsworth Jamie Cronquist Holly Nunn

This year, the CCPA created four subcommittees to carry out initiatives that were identified in the strategic plan. The advocacy subcommittee was responsible with providing the leadership team legislative updates at monthly meetings. The education subcommittee brainstormed new ideas to increase CE opportunities for members interested in chronic care topics, and plans to host Sunday Webinar series with NCAP in February 2026. The engagement subcommittee planned the social event for NCAP convention this year and is spearheading an initiative to create a mentorship program for pharmacy students who express interest in working with chronic care pharmacist careers. Finally, the membership subcommittee worked on initiatives to help improve recruitment of members to chronic care and to NCAP. The team started the first half of the year with preparing for the annual NCAP convention, held in Asheville, NC in June 2026. At the convention, the CCPA hosted a Sip and Mingle get together at the hotel on Monday night of the convention. This event was Page 38

graciously hosted by our engagement subcommittee members. This provided an opportunity to gather and meet different chronic care pharmacists across the state. There was a great turn out of individuals who serve on the leadership committee and other individuals practicing in the chronic care space.

We will also welcome our new chair elect, Keri Medlin, for 2026.

We look forward to continue expanding our initiatives in 2026!

COMMUNITY CARE PRACTICE ACADEMY The Community Care Practice Academy has experienced a time of transition in the 2025 year. With transition comes the opportunity for reflection on the past and planning for the future. We are excited to be engaged in a time of strategic planning for the Community Care Practice Academy, developing a 3-year plan to guide us in 2025-2027. We welcome input from all community practitioners, so please send your ideas (big and small) our way!

We recognize and appreciate community pharmacist members who have been actively engaged in advocating for PBM reform and payment for pharmacist provided patient care services legislation.

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With Medicaid recognition of pharmacists as providers, the Academy has been encouraging community pharmacists to enroll.

The 2025 elections were exciting for our Academy as well, as we received interest from many members to fill four at-large seats on the Academy leadership team.

We are excited to welcome the new leaders in the coming year as we finalize and launch the new strategic plan. We also express heartfelt gratitude for the leaders who will be ending their terms at the end of 2025. Thank you for your service!

HEALTH-SYSTEMS PRACTICE ACADEMY The NCAP Health Systems Society (NCSHP) experienced an extraordinary year marked by innovative achievements, strengthened connections, and a renewed commitment to its mission. Through the dedication of its members and the visionary leadership of the Health Systems Practice Group (now Society) Leadership Group, NCSHP set new standards for excellence in healthcare practice and collaboration.

Central to the Society’s success was the Health Systems Leadership Group under the guidance of Chair Trent Beach.

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His steadfast commitment to fostering innovation, inclusivity, and professional growth empowered the Society to reach new heights. Under his leadership, initiatives were advanced that enhanced patient care, supported professional development, and strengthened collaboration across health systems statewide. The Society extends sincere appreciation to Trent Beach and the entire leadership team for their guidance and impact.

The Society proudly recognizes the outstanding contributions of its 2025 Health-Systems Society Leadership Team and ASHP Delegates who supported this vision of excellence and progress.

Tyler Vest, Immediate Past Chair and Alternate ASHP Delegate, continued to provide invaluable mentorship and guidance, while Chair-elect Sacha Pollard Deloney brought fresh perspectives and energy. At-large members Dave Sugrue, Toni Currin, Dustin Wilson, Chris Barringer, Christopher Miller, Manali Patel, Rushabh Shah, and Eddie Seijo each contributed their expertise and passion, ensuring the Society thrived through collaboration and innovation.

ASHP Delegates Anne “Andy” Warren, Leslie Barefoot, Nick Gazda, and Jeff Reichard represented the association with

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distinction, advocating for pharmacy professionals at the national level. Together, these leaders exemplified dedication, unity, and a relentless pursuit of excellence.

During the year, NCSHP also completed a comprehensive refresh of its strategic plan. This process engaged members at all levels and encouraged diverse perspectives to help shape the Society’s future. The refreshed plan sharpens focus on advancing clinical excellence, fostering interdisciplinary collaboration, promoting health equity, and leveraging technology to improve patient outcomes. With aligned priorities and a clear vision, NCSHP is well positioned to respond proactively to the evolving healthcare landscape.

The Chair’s Agenda introduced by Dr. Beach played a key role in deepening connections within the broader practice group. Through targeted outreach, collaborative programming, and new partnership initiatives, the Society strengthened its role as a hub for knowledge exchange and professional support. Efforts included planning forums for bestpractice sharing, mentorship opportunities, and advocacy activities that amplified the voices of healthcare professionals across the network, reinforcing the Page 40

Society’s commitment to positive change and continuous improvement.

As the Society reflects on the accomplishments of the past year, it remains energized by both the progress achieved and the opportunities ahead. NCSHP continues to focus on empowering its members, driving innovation, and building resilient health systems. With a refreshed strategic plan and a leadership agenda centered on connection and growth, the Society is well prepared to move forward as leadership transitions from Trent Beach to Sacha Pollard Deloney.

The Society extends heartfelt thanks to every member who contributed to this year’s successes. The passion and commitment of its community remain the foundation of NCSHP’s achievements. Together, members will continue to elevate the Society, support one another, foster professional growth, and lead meaningful change that benefits patients, institutions, and communities across North Carolina.

NEW PRACTITIONER FORUM This year, the New Practitioner Forum (NPF) continued its focus on connecting new practitioners

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and student pharmacists, offering the support they need during the early stages of their careers.

Through a mix of educational and networking opportunities, we worked to strengthen professional development and foster meaningful relationships across North Carolina.

Our Leadership Buzz series remained a cornerstone of engagement, featuring thoughtprovoking discussions on books such as The People’s Hospital by Ricardo Nuila, Compassionomics

by Stephen Trzeciak and Anthony Mazzarelli, and Think Again by Adam Grant. We also introduced our first podcast discussion, highlighting the ASHP Podcast episode To Err Is Human. All of our speakers were phenomenal pharmacy leaders from across the state, and we look forward to welcoming even more pharmacists and students to join us in the spring.

The Emerging Leaders Program continued with a special focus on advocacy this year. Jessica Stout, PharmD, led an excellent session on the basics of advocacy, and we plan to build on this momentum by sending representatives to Legislative Day in the spring.

We also strengthened our collaboration with the Student Practitioner Forum by hosting a Residency Q&A session designed Page 41

to help students navigate the residency application process. In addition, we launched our new Mentorship Chat Line: Ask a New Practitioner, a resource for pharmacy students seeking guidance on career development, residency preparation, and professional growth. Topics include career path exploration in clinical, ambulatory, industry, and academia settings, residency applications such as PGY1 and PGY2, CVs, interviews, and letters of intent, board certification and licensure preparation, and mentorship and networking opportunities. Responses are reviewed weekly by NPF members, who provide personalized advice and support.

We have even received interest from other practice groups eager to serve as mentors, further expanding our reach.

Looking ahead, we are excited to enhance our Networking Speed Dating event to make it even more impactful, and we will continue building social events to bring new practitioners together. Keep an eye out for our spring events. We hope to see you there!

STUDENT PHARMACIST FORUM The Student Pharmacist Forum (SPF) of NCAP has had a productive and collaborative year, focusing on expanding leadership

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development, professional growth, and meaningful partnerships for student pharmacists across North Carolina. This year, SPF worked closely with the NCAP New Practitioner Forum (NPF) to host a residency panel immediately following the NCAP Residency Showcase, giving students valuable insight into the residency application process. SPF also collaborated with NCAP-NPF to share information about new resources, including their recently launched mentorship program, ensuring students have access to tools that support their career development. Looking ahead to next semester, NCAP-SPF will continue its advocacy series events at the start of the year, building on the momentum of this year's accomplishments and further empowering students to engage in pharmacy advocacy statewide. Next year we will also be partnering with Chronic Care Pharmacy to host a panel and launch a new mentorship initiative that connects students with practitioners in chronic care settings.

Interested in volunteering for a committee, task force, or special project? Click Here or go to ncpharmacists.org to learn how you can get involved!

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