North Carolina Pharmacist Volume 103 Number 2

North Carolina Pharmacist Volume 103 Number 2

Advancing Pharmacy. Improving Health.

Save the date for the 2023 NCAP Convention being held June 4-6 at the Beaufort Hotel in Beaufort, NC

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

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

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

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

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

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

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

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

North Carolina Pharmacist

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

Volume 103 Number 2

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

A Few Things Inside

LAYOUT/DESIGN Rhonda Horner-Davis

• From the President..................................................................................................4

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

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

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

• Our Work In Progress..............................................................................................6

• Navigating Pharmacy School Through A Global Pandemic..................................11 • Guidelines for Gonococcal Infections...................................................................15 • New Drug Monograph..........................................................................................18 • Long-Acting Injectables Antipsychotics Quick Reference..................................22

• Convention Pics...................................................................................................24 • Sponsors and Exhibitors.......................................................................................36 • 2022 Awards........................................................................................................42 • 50 Plus Club.........................................................................................................46

• FNCAP Designees...............................................................................................47 • Rite of Roses.........................................................................................................48 • Scientific Poster Presentations..............................................................................52 • Roundtable Discussion Topics & Descriptions......................................................54 .

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North Carolina Pharmacist is supported in part by: • VUCA Health ..............................................................................5 and 57 • Alliance for Patient Medication Safety (APMS).....................................5 • EPIC Pharmacies Inc ..............................................................................9 • Pharmacy Quality Commitment ...........................................................10 • Pharmacy Technician Certification Board (PTCB) ..............................14 • NCAP Career Center ............................................................................17 • Edupharmtech .......................................................................................20 • Working Advantage ..............................................................................20 • Pharmacists Mutual Companies ...........................................................21 • Your Community Health Plan ..............................................................58 CORRECTIONS AND ADVERTISING For rates and deadline information, please contact Rhonda Horner-Davis at rhonda@ncpharmacists.org

Connect With Us!

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•From the President• Matt Kelm, PharmD

• We need the passage of fair reimbursement legislation to help ensure that pharmacists are compensated for the care they provide Colleagues, What a whirlwind the past three months have been for NCAP! Since my last article in the journal, we have had our legislative day and annual convention. Both events were wildly successful. In this month’s column, I wanted to provide some highlights from each event.

On May 25th, we had a strong contingent of well over 40 pharmacists and pharmacy students from across the state meet in Raleigh to speak with our state representatives in the North Carolina General Assembly. We had the good fortune to speak with well over a dozen state senate and house members on issues of priority to NCAP. These topics included: Collaborative Practice • We would like to modernize our current Collaborative Practice Act to better serve our patients as an inter-professional healthcare team • We need all our healthcare professionals to practice to the height of their education and training Reimbursement for Pharmacy Services

Pharmacy Benefit Managers • We would like to build upon the consumer protections that came out of Senate bill 257 • We hope to better protect small, independent pharmacies from the harsh and unfair business practices of PBMs Test and Treat • >25% of states have expanded pharmacists’ ability to test and provide treatment for minor illnesses such as strep throat, flu, urinary tract infections, and preventing HIV transmission • The ability to test and treat in the pharmacy increases the public’s access to care and helps to prevent delays which can reduce healthcare costs One of the day’s highlights came late in the afternoon when our membership convened in the gallery of the House of Representatives. After observing the business of the house for the day, Representative Wayne Sasser called on Speaker Moore to have the assembly welcome and recognize the pharmacists present for the day.

It was a wonderful experience to Page 4

receive warm recognition from our elected state officials.

On a personal note, I wanted to share three impressions from the day: 1. How easy it was to engage with our representatives.

They were friendly, courteous, and genuinely open to hearing from us.

2. How effective our lobbyists and Executive Director are at cultivating relationships and communicating with the “pharmacy champions” in the legislature. Tony, Deb, and Penny truly are making our voices heard and advancing pharmacy in North Carolina.

3. I would be remiss if I did not take this opportunity to encourage my fellow pharmacy professionals to engage.

Through contributions to the NCAP Advocacy Fund, Pill PAC, and engagement with lawmakers, we can impact our state’s practice.

I also wanted to highlight our annual convention held on June 9th and 10th in Winston-Salem.

I was astonished by how much I missed interacting in person with colleagues from across the state rather than via another Zoom meeting! The convention was extremely well organized by the

planning committee and executed

by NCAP staff. I found the programming to be some of the highest quality and engaging I have experienced in many years of attending several state and national conferences. We are fortunate to have such talented presenters in our home state. There are many highlights of the convention to share.

Beyond the excellent educational programming, we also experienced robust support from exhibitors and industry partners, engagement with state legislators, and a memorable awards ceremony where we inducted our inaugural NCAP Fellow Practitioner Recognition class. Lastly, I wanted to recognize the efforts of our president-elect Ouita Gatton. Ouita spearheaded a delightful casino night social full of fun, laughs, and excellent prizes.

For those in attendance, it was a social event to remember! With the excitement and momentum from our most recent events, I am happy to share that next year’s annual convention will be held June 4th-6th at the Beaufort Hotel in Beaufort, NC. This resort-style setting will certainly be a can’t miss convention in 2023.

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

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

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Our Work In Progress: Population Health From One Pharmacy Team’s Perspective By: Dr. Samantha J. Seivert Dr. Michelle Rager Population health is a hot topic in healthcare, but it lacks a concrete definition. According to the Centers for Disease Control, population health “brings significant health concerns into focus and addresses ways that resources can be allocated to overcome the problems that drive poor health conditions in the population.” (1) Population health offers an opportunity for key stakeholders in the healthcare industry to work together to improve the health outcomes of the patient populations they serve. Excellence in healthcare is shifting more towards value-based outcomes that focus on the quality of patient care rather than the number of patients seen or services provided as evidenced by quality metrics set

by Accountable Care Organizations (ACO), Coordinated Care Organizations, and insurance payors.

The quality metrics center around controlling common chronic disease states such as hypertension, diabetes mellitus, dyslipidemia, smoking cessation, and medication adherence which are high-cost and high-burden to healthcare.

Pharmacists have a unique skill set that positions them as essential members of the population health team, including the ability to “develop and implement population-specific, evidence-based disease management programs and protocols based upon analysis of epidemiologic and pharmacoeconomic data, medication use criteria, medication use review, and risk reduction strategies.” (2) Doctor of Pharmacy education prepares students to effectively evaluate and apply evidence-based medicine to patient care and to collaborate with members of the healthcare team to promote an interdisciplinary approach to healthcare.

At the health system level, Center for Medicare and Medicaid Services requirements often direct quality metrics set by the ACO, such as a collective A1c goal of < 9% for patients with diabetes, rather than focusing on guideline-directed patient-specific goals that may be as low as < 7%. Another example would focus on hypertension management with population-specific blood pressure goals Page 6

that may differ from patient-specific goals based on individual comorbidities and risk of adverse effects. Provider dashboard reports within the electronic health record can help identify if these metric goals are being met; however, the reports do not give information about prescribing patterns or disease management strategies that may help improve quality metrics. While the dashboards will allow the data to be filtered to a patient-specific level, further review of the dashboard report and patient’s chart is often needed to determine the next steps, which is time-consuming.

Standardized quality metrics across a health system can be advantageous because it allows for coordinated efforts of providers and other members of the healthcare teams. Employing an interdisciplinary team allows for targeted focus by clinicians and staff on their areas of expertise. Clinical Pharmacist Practitioners (CPP), with their specialized licensure, offer an advantage when working on population health metrics be-

cause they can be involved in the chart review process and provide a timely response by prescribing appropriate medication therapies and providing comprehensive education to the patient. On the other hand, pharmacists may not always have an established relationship with the patient in question, or a referral from the provider may be required for the pharmacist to make changes in therapy. Additionally, the CPP or any other team member may focus on the report that is metric specific and identify a patient for possible intervention.

At the same time, another discipline or provider may have also seen the same patient in need of other interventions. Plan coordination may fail until the reporting focuses on the patient’s needs rather than the metric alone.

Payor-based population management programs partner with payor sources, including Medicare Advantage Programs, to supply providers’ claims data related to population metrics. Some initial data analytics have been completed on the claims data to compile a list of patients who have identified gaps in care. Claims data can be beneficial to predict a patient’s adherence and track how effectively a practice is doing in metrics throughout the measurement year.

Alternatively, the data is limited to insurance claims, so it may not accurately reflect the patient’s medication utilization if a patient received samples, used a copay card, or had a dose decrease resulting in additional medication on hand. The data comes from an outside source, so it is typically unavailable to the provider during a patient encounter. While claims data may have predictive value for

the patient’s achievement within the one measure, payors often provide multiple reports for different metrics. It can be difficult to determine where attention should be focused first. Many patients can appear on multiple reports making it difficult to provide comprehensive patient care until all data is compiled and combined.

Novant Health New Hanover Primary Care is a hospital-affiliated clinic within a larger health system that manages chronic disease states with a team of physicians, pharmacists, nurses, and medical support staff. Within this provider group, targeted populations for review may be defined by beneficiaries of specific payors or within the ACO and patient panels for the practice and system level. Strategies for managing each of these populations can differ slightly and provide unique opportunities and challenges. This practice has created a team to support the clinic’s population health efforts, led by a Manager of Care Coordination that serves as a liaison between the insurance companies and the clinic providers and staff working on population health metrics.

Our pharmacy team contributes through the work of three CPPs, with the equivalent of two fulltime positions, a dedicated medical assistant and a PGY1 Community-Based Pharmacy Resident who spends one day a week in the practice longitudinally. Additionally, pharmacy residents from the PGY1 Pharmacy and PGY2 Ambulatory Care residency programs and Advanced Pharmacy Practice Experience students will rotate through the clinic. The team’s primary focus is running a full-time disease management service with Page 7

telemedicine and office encounters and responding to patient and provider requests. Additional responsibilities include resident and student teaching opportunities, drug information, and spearheading population health action plans.

As a pharmacy team, we work to address many of the barriers mentioned above to help providers improve medication-related population health metrics. At the start of each calendar year, the team reviews Red Reports from the payors, a list of patients who failed a measure in the previous year, to triage what patients may be the highest priority. This information often includes multiple reports for the different medication-related metrics, making it difficult to determine what patients need help. The first step for our team is to combine the reports into a single document so that all necessary information is in one convenient space.

This also allows us to determine if patients have failed more than one measure so that a streamlined plan to help the patient can be developed. Analyzing and compiling the reports also includes reviewing the patient’s chart to understand how to best help the patient. This manual review process provides some information about why the patient may have failed and what proactive strategies can be implemented to better care for the patient. Once a strategy is determined, recommendations may either be sent to the provider for possible intervention at an upcoming visit or a request for referral to the pharmacy team for that patient. As mentioned, our team consists of CPPs that have the privileges of managing and prescribing medications.

Still, interventions are more likely

effective when a formal relationship has been established between the patient and our care team. One of the keys to helping providers in the care of the patient is to ensure our recommendations make it to them at the right time. We have used a variety of methods of communication. Still, those that appear to be most successful include appointment notes in the electronic health record provider schedule or attempting to catch the provider before an appointment. The latter is not easily achieved for our small team and a provider panel of over 50 providers with eight offices in a three-county area.

Towards the end of the calendar year, payor reports are sent out with a list of patients at risk for failing a measure. Again, the pharmacy team assists by collecting relevant patient information from the reports and patient charts to develop an action plan to address gaps in care. Unfortunately, closer to the end of the measurement time frame, the pharmacy team is often forced to rely on calling the patient in hopes of making any medication-related changes.

This often becomes problematic for a variety of reasons: the patients do not understand the role of a pharmacist, may not have an established relationship with the pharmacist, may want to consult with their primary provider before making any changes, or are skeptical of why a change may be necessary if not previously addressed by the primary care provider, and it may take multiple attempts to reach a patient. Suppose a care gap is unable to be closed. In that case, other pharmacies or insurance companies may also be attempting to contact the patient, resulting in

multiple calls about similar topics, often leading to frustration for both parties.

Despite the difficulties highlighted above, a team-based approach is key to achieving population-based outcomes. Our practice has successfully met star metric goals year after year by having pharmacists and other clinical staff looking at care gaps and spending additional time on the education and management of patients. Yet, more integrated practice designs with pharmacists embedded in clinics for population health and disease management efforts would improve outcomes. In smaller practices, a lack of reimbursement structure from commercial and government payors for pharmacists, even CPPs with prescribing privileges, may prevent the development of a sustainable financial model with this integration. This is even a challenge in larger health systems, but the additional responsibilities and contributions of the pharmacy team may make this relationship more viable. With those additional responsibilities, the challenge of adequate time to focus on manually evaluating, tracking, and intervening on patients can be a significant barrier.

With or without additional pharmacist time and dedication to population health efforts, one of the most vital developments needed is an automated system to identify the highest risk patients that would benefit from pharmacist intervention and bring the attention to care gaps or opportunities for therapy optimization to the provider at the time of encounter. With electronic health records, many possibilities for data analytics and best practice Page 8

advisories exist, yet we cannot forget about the reality of alert fatigue. Well-timed and vital information must be presented to the provider when treating the patient.

Yet every visit may not be the opportunity to focus on preventative interventions. Notifications of care gaps to providers will be the most effective if they align with annual wellness or comprehensive visits rather than acute encounters or hospital follow-ups in many cases.

In these routine visit situations, the provider will have the time to focus on these conversations, and the patient is likely more amenable to this type of treatment. We have seen firsthand how clinical inertia has likely contributed to missed opportunities. Patients who present for several acute visits or even a routine follow-up with several patient complaints may not have been evaluated for primary prevention of cardiovascular disease using a statin if a primary care provider has approximately 15 minutes with the patient to address all the necessary concerns. Indeed, there can be an argument for a longer time spent with patients.

Still, the current model for reimbursement and the overwhelming need for providers to see more and more patients given provider-to-patient ratios leaves little room for schedule adjustment. A model that brings interdisciplinary care to the patient on a routine basis can undoubtedly assist in this area. And when there is a relationship established between the patient, primary care provider, pharmacist, clinical staff, and specialists, missed opportunities lessen.

Lastly, while we are proud of the achievements our pharmacy team, providers, and health system have

made in recent population health efforts, the missing piece still seems to be the inability of our current system to help those not seen in our offices. Missing data may mean that the health of the actual population is quite different than we expect. Additionally, the likelihood that those patients not seeking regular healthcare are meeting expected disease and population goals are dim. Also, our efforts in many ways are about treating or preventing further complications in patients already diagnosed with disease. More efforts are still needed in disease prevention and overall health in our communities, state, and nation.

As healthcare delivery continues to evolve, a concerted effort to utilize technology to prioritize and direct treatment to each patient in a pop-

ulation will be the most effective way to achieve overall health for that population. Additionally, we believe the utilization of an interdisciplinary team remains the most effective strategy for providing comprehensive and quality healthcare. This is our work in progress.

Authors: Samantha J. Seivert, PharmD, is a PGY1 Community-Based Resident at Novant Health New Hanover Regional Medical Center; Samantha.seivert@nhrmc. org. Michelle Rager, PharmD, BCPS, BCACP, CPP is a Clinical Pharmacist Practitioner and PGY1 Community-Based Residency Program Director at Novant Health New Hanover Regional Medical Center.

possible financial or personal relationships with commercial entities (or their competitors) that may be relevant to this article.

References: 1.

Centers for Disease Control and Prevention. (2020, October 6). What is population health?

Centers for Disease Control and Prevention. Retrieved April 3, 2022, from https://www.cdc.gov/ pophealthtraining/whatis.html 2. American Association of Colleges of Pharmacy. Educational Outcomes 2004. Alexandria VA: Center for the Advancement of Pharmaceutical Education Outcomes; 2004. http://www.aacp. org/resources/education/Documents/CAPE 2004.pdf.

Disclosures: The authors have nothing to disclose concerning

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A Perspective - Navigating Pharmacy School Through A Global Pandemic By: Avery Taylor Dr. Emily Ghassemi Dr. Tina Thornhill

Since my junior year of high school, my goal has been to become a pharmacist. While working my way toward pharmacy school, I talked to many pharmacists and student pharmacists to get an idea of what I could expect. They spoke of their years, recalling the long hours of studying, making friends, the various organizations, and having fun. I started pharmacy school in the fall of 2019. Almost everything I was told rang true, except for the online-only classes, facemasks, and social distancing, a jarring life and academic shift I faced in the second semester of my program.

As I reflect on the past two years, it is important to see where I have been and what I have learned about myself and my profession.

One of the most significant changes occurring on campuses across the country was the move to online-only classes. Initially, there was a novelty to attending classes online with the expectation of it being only temporary. The shift, however, became a harsh reality

when it was apparent that we would not return to campus for the remainder of the semester.

The professors did an excellent job of trying to maintain consistency, but moving classes exclusively online was also new to many of them. We had lectures through pre-recorded videos, live Blackboard Collaborate sessions, and Zoom calls. It was not easy keeping up with the multitude of sources we shifted to using. I did my best to manage all the lectures, but there was more than once when I was scrambling a day before a quiz or test trying to find a class I missed because it was pre-recorded.

I also discovered that I had a more difficult time paying attention during online classes; it was easier to have my attention pulled away from the material at hand. I struggled to stay on task watching the rates of COVID-19 infection rise.

Some days, the worry was endless with the seemingly imminent danger of contracting COVID-19 Page 11

and calling home to check on the status of family and friends. Plus, there were always issues related to problems with technology and internet connections. When my roommate (who was a year ahead of me) and I were attempting to watch live lectures simultaneously, it was inevitable that one of us would lose signal and get booted from our class. The added stressors of the change in course instruction, technical problems, and uncertainty of what was transpiring in our communities brought the worry and stress of pharmacy school to a much higher level.

Going to pharmacy school through the pandemic also changed how I studied. Before in-class instruction ceased, I relied heavily on studying in groups. Of course, this was not possible during the early stages of the COVID-19 pandemic, and I had to figure out a new way to learn.

Lab instruction was another change that came with COVID-19.

In the spring of 2020, my class-

mates and I were learning about diabetes. Laboratory sessions are essential to understand the many diabetes products (e.g., glucose meters, insulin pens, and GLP-1 agonists). Laboratory instruction is also where we practice counseling patients effectively. Watching and learning via a computer screen replaced the “hands-on” approach. The simulation of online counseling also proved to be more difficult. Trying to show someone how to use a glucometer for the first time can be hard task, made even more difficult without being able to physically guide patients through the hands-on task with a demo device.

Pre-COVID-19, participation in extracurricular activities was a large part of how I relieved stress.

The initial lockdown phases of the pandemic caused all meetings and events to be canceled. The joy of in-person engagement was lost as we felt the “online overload.” As it became more evident that we would be online for the remainder of the semester, we started online meetings and events. Online meetings did not allow for the same stress relief as being around people and having time away from my laptop. These meetings became more stressful and harder to focus on, especially as it became apparent the changes would be less temporary than originally expected.

The pandemic also changed how our experiential education (rotations) was handled. The CPHS PharmD Class of 2020 completed their last rotations virtually. All introductory pharmacy practice experiences (IPPEs) scheduled for May 2020 were canceled. Some

community pharmacies permitted the return of students in June, while hospital pharmacies remained closed to students. More community and hospital pharmacies opened to students in July.

The advanced pharmacy practice experiences (APPEs) for the Class of 2021 also shifted due to limited personal protective equipment (PPE) and available working space.

Patient interactions in community pharmacies were limited to a drive-through or drive-up encounter. Inpatient interactions were almost non-existent and rounding with providers was primarily virtual. All IPPEs and APPEs became primarily focused on mass immunizations in every community.

Infection control concerns also resulted in holding preceptor/student group meetings virtually.

Students who were out due to infection or isolation precautions quickly fell behind in their studies.

Although faculty and preceptors were understanding and willing to provide accommodations, frustration was inevitable given the stress of knowing a different level of learning and teaching was necessary.

When classes first transitioned to a remote format, I was excited to wake up five minutes before class and stay in pajamas all day; however, I quickly learned how dramatic the change would become.

COVID-19 changed the world on every level, from government response to human interaction and everything in between. So, what were the “positives” that came from the pandemic?

The many challenges faced while attending pharmacy school during the COVID-19 pandemic can also Page 12

be viewed as opportunities. One positive that came from mandated online learning was the implementation of new technology and becoming familiar and more comfortable with it. In doing so, we have expanded the capabilities for classroom instruction and collaboration we never considered possible. Another benefit gained from the online format was learning to use telehealth and providing patient counseling virtually. I learned to be extremely careful with my word choices and provide enough detail to ensure that my patients understood what to do.

As I matriculate into my senior year, I am grateful to have had this practice and to feel comfortable being able to counsel patients in this virtual setting.

The pandemic showed us that if we join together and remain open-minded, we can devise ways to meet the goals of our organizations. For example, we created online fundraisers and virtual health fairs. What initially seemed to be a death blow to our earlier plans became a very tangible benefit for the community. The APhAASP chapter was able to create an online health fair and post a wide variety of health information online for people to access. The all-digital format allowed us to be creative and, more importantly, to reach a larger demographic.

These opportunities also allowed more students to participate as it did not require them to be on campus.

An ever-changing landscape of restrictions and guidelines taught us to be comfortable in new situations and to always be willing to adapt and change with

revised information. Information is the primary weapon in the fight against disease and illness. By living through a global pandemic, I believe we have become stronger at gathering and implementing new information into our lives.

The challenges of learning during this time were many and, at times, seemed nearly impossible. Still, they have given my colleagues and me a brand-new skill set and a deep appreciation of this profession that could lead to future advancements and care.

One thing that became clear through the pandemic is how essential pharmacists are at every level of care. Witnessing the importance of pharmacists as first-line workers gave my classmates and me a sense of pride. It also showed us the importance of what is being taught as we recognize that “we” will soon be on the front lines as pharmacists.

COVID-19 has personally and professionally affected every part of our lives, and for me, Campbell’s motto, Ad astra per aspera, (“to the stars through difficulties”), could not mean more!

Last Call to Register!

2022 Residency Conference TUESDAY, JULY 26, 2022 8:30 AM - 3:30 PM HIGH POINT UNIVERSITY CONGDON HALL This annual conference is for North Carolina residency programs. It brings together residency program directors, preceptors and PGY1 and PGY2 residents all in one space to help each program make the most out of the year in residency. Join us for general sessions for all, open discussion topics for preceptors, and breakout sessions for residents. Light breakfast and lunch will be served; the registration fee is $50 per person. Click here to register your group by the July 19th deadline!

Authors: Avery Taylor is a P4 Doctor of Pharmacy Candidate at Campbell University College of Pharmacy & Health Sciences (CPHS), antaylor0709@email.campbell.edu. Dr. Emily Ghassemi, BCACP, CDCES, CPP is a Clinical Assistant Professor at CPHS, and Dr. Tina Thornhill, FASCP, BCGP is the Vice-Chair of Experiential & Professional Education and Professor at CPHS. Page 13

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A Review of the 2020 Updates to CDC STI Guidelines for Gonococcal Infections

By: Dr. Abigail Comer, Jessica Dorrough, Dr. Ruthanne Baird, Dr. Justin Hodges, and Dr. Kristen Keen Gonorrhea is the second most common bacterial communicable disease, with around 1.5 million new infections diagnosed every year. Since 2014, the incidence of gonococcal infections caused

by Neisseria gonorrhoeae has increased by 63%. (1) In North Carolina, the incidence of gonococcal infections is 529.7 infections per 100,000 persons. (2) Neisseria gonorrhoeae is a gram-negative diplococcus with unique factors that allow it to successfully cause disease in patients worldwide. It has adapted to develop mechanisms of pathogenesis, more specifically resistance mechanisms, that are useful due to the site of infection. (1,3) One of the primary reasons for its increased pathogenesis is due to the ability of the bacteria to cause infection yet affected individuals may remain asymptomatic. (4) Symptoms of gonococcal infections include vaginal/penile discharge, painful and burning urination, swollen testicles, back pain, and painful bowel movements. (1,3-4) Sequelae from unresolved gono-

coccal infections include pelvic inflammatory disease, pregnancy and fertility complications, and increased human immunodeficiency virus (HIV) transmission.

(3-4) Complications for pregnant may include spontaneous abortion, preterm births, or low birth weight infants. (4) The difference in presentation between men and women is primarily driven by the presence of symptoms. Men with gonococcal infections of the urethra are almost always symptomatic (98-99%), whereas most women with gonococcal infections of the cervix are asymptomatic (50-80%).

(4) Gonococcal infections of the pharynx are primarily asymptomatic and may be a driver of increased antimicrobial resistance. (4) Extensive research is ongoing to identify virulence factors that allow N. gonorrhoeae to cause cervical gonococcal infections in women without causing symptoms. To date, researchers have found that N. gonorrhoeae can bypass the normal complement alternative pathway, which allows cervical epithelium invasion. (5,6) Page 15

The Centers for Disease Control and Prevention (CDC) implemented prevention and treatment strategies to combat gonococcal infections and updated treatment recommendations in 2020. (1) This is due to the increased rates of azithromycin resistance to N. gonorrhoeae. Rates have increased by more than seven-fold in the past six years (0.6% to 4.5% in 2018). (3) Pharmacokinetic analyses revealed that previously recommended doses of ceftriaxone (250mg IM x 1 dose) were not enough to reach an MIC higher than 0.125mcg/mL for an extended duration. (7) However, a one-time ceftriaxone dose of 500mg IM was 100% effective at eradicating N. gonorrhoeae 48 hours after treatment. (7,8) Given the results of this analysis and increasing azithromycin resistance rates, the preferred treatment for N. gonorrhoeae infections is now ceftriaxone 500mg IM x one dose.

(1) Dual therapy with the addition of azithromycin is no longer recommended. Table 1 illustrates treatment guidelines including dosing and alternative therapies.

North Carolina allows permissible treatment of partners of affected individual patients. Expedited partner therapy (EPT) is recommended for all partners of affected patients that are unwilling or unable to be evaluated by a physician. (9) It is recommended that all sex partners of the affected patient within the 60 days prior to the diagnosis of infection be treated. If the patient’s last sexual encounter was more than 60 days prior to diagnosis, it is recommended that the most recent sex partner be treated. Not

all patients are eligible for EPT, and pharmacists should be aware of the exclusions when patients present to pharmacies for EPT. Gonococcal infections of the pharynx (throat) or in male patients that have sex with other men are excluded from EPT. These patients need to be referred to a physician for evaluation. Pharmacists are provided with handouts to give to patients when picking up prescriptions for their partners, and all partners are encouraged to contact the pharmacy for counseling upon

receiving the prescription. (9) Pharmacists are a valuable resource to both physicians and patients alike, especially when it comes to antimicrobial stewardship and proper treatment of sexually transmitted infections.

Regardless of the practice setting, pharmacists should be knowledgeable of current guideline recommendations and know the resources, such as expedited partner therapy, which are available to patients.

Table 1: Treatment Regimens for Uncomplicated Gonococcal Infections

Infections of the cervix, urethra, or rectum

Patients <150kg

Alternative if cephalosporin allergy:

• Single-dose ceftriaxone 500mg IM

• Single-dose gentamicin 240mg IM + single-dose azithromycin 2gm PO

Patients ≥150kg • Single-dose ceftriaxone 1000mg IM Chlamydial infection NOT excluded:

Alternative if ceftriaxone not available (reduced efficacy) Single-dose cefixime 800mg PO (add doxycycline if chlamydia infection not excluded, azithromycin if pregnant)

• Add doxycycline 100mg PO BID x 7 days Infections of the pharynx

If pregnant • Single-dose azithromycin 1gm PO

No reliable alternative therapy for pharynx infections. Consult with an infectious disease specialist if the patient has anaphylactic allergy to ceftriaxone/beta-lactams.

Gonococcal expedited partner therapy: Permissible in NC ● Useful if partner of the patient is unable or unlikely to seek timely treatment ● Single-dose cefixime 800 mg PO (add doxycycline if chlamydia infection in patient has not been excluded)

Authors: Abigail Comer, PharmD, MSCR, is a PGY-1 Pharmacy Resident at Harnett Health and CPHS, alpenninger0818@email. campbell.edu; Jessica Dorrough is a P3 Candidate at CPHS; Ruthanne Baird, PharmD, BCPS, Justin Hodges, PharmD, and Kristen Keen, PharmD are at Harnett Health.

References: 1, SS, Barbee L, Workowski KA, et al. Update to CDC’s Treatment Guidelines for Gonococcal Infection, 2020. MMWR Morb Mortal Wkly Rep. 2020 Dec 18;69(50):1911-1916.

2, Gonorrhea in North Carolina, 2020. North Carolina Department of Health and Human Services HIV/STD/Hepatitis Surveillance Unit. https://epi. dph.ncdhhs.gov/cd/diseases/gonorrhea.html. 2021 Sep 22.

3, CDC Sexually transmitted disease surveillance 2018. Atlanta, GA: US Department of Health and Human Services, CDC; 2019. http://www.cdc.gov/ std/stats18/STDSurveillance2018-full-report.pdf 4. Edwards JL. The role of complement in gonococcal infection of cervical epithelia. Vaccine. 2008 Dec 30;26 Suppl 8:156-61.

5. Edwards JL, Brown EJ, Ault KA, Apicella MA. The role of complement receptor 3 (CR3) in Neisseria gonorrhoeae infection of human cervical epithelia. Cell Microbiol 2001;3:611–22.

6. Edwards JL, Brown EJ, Uk-Nham S, Cannon JG, Blake MS, Apicella MA. A co-operative interaction between Neisseria gonorrhoeae and complement receptor 3 mediates infection of primary cervical epithelial cells. Cell Microbiol 2002;4:571–84.

7. Chisholm SA, Mouton JW, Lewis DA, Nichols T, Ison CA, Livermore DM. Cephalosporin MIC creep among gonococci: time for a pharmacodynamic rethink? J Antimicrob Chemother. 2010;65:2141–8.

8. KL, Eakin AE, Gomez C, Osborn BL, Unemo M, Jerse AE. Pharmacokinetic data are predictive of in vivo efficacy for cefixime and ceftriaxone against susceptible and resistant Neisseria gonorrhoeae strains in the gonorrhea mouse model. Antimicrob Agents Chemother. 2019;63:e01644–18.

9. North Carolina Board of Pharmacy Expedited Partner Therapy. http://www.ncbop.org/faqs/Pharmacist/ExpeditedPartnerTherapyFAQsMay2016.

Page 16

Page 17

New Drug Monograph

Ztalmy (Ganaxolone)

By: Dr. Chanel Charles-Mwanza ZtalmyTM (ganaxolone) is manufactured by Marinus Pharmaceuticals, Inc. and was approved by the FDA on March 18, 2022.

Classification1: Neuroactive steroid gamma-aminobutyric acid (GABA) A receptor positive modulator Indication1: Approved for the treatment of seizures associated with cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder (CDD) in patients ≥2 years of age.

Contraindications1: None Pharmacology : Ganaxolone exerts its therapeutic effects in the treatment of seizures associated with CDD by positive allosteric modulation of the synaptic and extrasynaptic GABAA receptors in the central nervous system (CNS).

1

Pharmacokinetics1: Absorption - Ganaxolone is orally absorbed and reaches peak plasma concentration within 2-3 hours.

When administered with a meal, the Cmax and area under the curve (AUC) increases. Ganaxolone was administered with a meal in the clinical study, therefore the efficacy is unknown under fasting conditions.

Distribution - Ganaxolone is approximately 99% protein bound.

Metabolism - Ganaxolone is metabolized by CYP3A4/5, CYP2B6, CYP2C19, and CYP2D6.

Elimination - Ganaxolone is excreted as unchanged drug in the feces (55%) and 18% unchanged drug in the urine. The approximate elimiPage 18

nation half-life of ganaxolone is 34 hours.

Clinical Efficacy2: Knight and colleagues conducted a double-blinded, randomized, placebo-controlled, phase 3 trial to assess the efficacy and safety of an investigational drug, ganaxolone, in patients with CDD-associated refractory epilepsy taking a maximum of 3 antiepileptic medications (AEDs). The trial was conducted at 39 outpatient clinics in 8 countries. Participants were eligible if they were 2-21 years of age, had a molecular confirmed CDKL5 variant that was pathogenic or likely to be pathogenic, a history of early-onset seizures that were uncontrolled despite trials of at least 2 antiseizure medications, and had at least 16 major motor seizures per 28 days during a 2-month period prior

to screening. Participants were excluded if they had West syndrome or seizures of a predominately infantile spasm type, an active CNS infection, demyelinating disease, or degenerative neurological disease. Patients were also excluded if they had abnormal liver function or considerable renal impairment.

There were 101 patients randomized in a 1:1 fashion to receive ganaxolone or matching placebo 3 times daily with food, as adjunctive therapy to existing antiseizure medications. Patients were assigned a unique number using an interactive web response system at screening and randomization.

Trial staff analyzing the data were masked to treatment allocation until the database lock and the treatment code were released. Baseline characteristics were similar between the study groups with most participants being 78% female, 92% were white, and the mean age was 6.8 years (range 2-21 years).

Patients received treatment over a period of 17 weeks. All patients receiving ganaxolone, except 1, were taking up to 4 concomitant antiepileptic drugs (AEDs) during the trial.

Ganaxolone 50 mg/mL or matching placebo was titrated for 4 weeks up to a maximum dose of 63 mg/ kg/day for patients weighing ≤28 kg or 1800 mg/day for patients weighing ≥28 kg. Seizure frequency was assessed via electronic diary entries by the patient’s caregiver throughout the trial. The Clinical Global Impression of Improvement (CGI-I) scale was used to assess seizure activity before and after the initiation of treatment.

The primary endpoint of the study was the percentage change in major motor seizure frequen-

cy per 28 days from the 6-week baseline period to the 17 weeks of the double-blind phase. The study used a primary efficacy measure of common CDD-related major motor seizures which included bilateral tonic, generalized tonic-clonic, bilateral clonic, atonic, or focal to bilateral tonic-clonic seizures.

Secondary endpoints included the proportion of patients with a reduction in seizure frequency of at least 50% from baseline to the 17 weeks of the double-blind phase and CGI-I scale score per caregiver and clinician assessments at the last scheduled visit of the 17-week double-blind phase.

There were statistically significant reductions in the 28-day frequency of major motor seizures in the ganaxolone group compared with placebo (-30.7% vs. -6.9%, p=.0036), corresponding to a mean difference of -27.1% (95% CI -47.9 to -9.6). For the secondary outcomes, 49 patients (24%) in the ganaxolone group and 51 patients (10%) had a reduction in seizure frequency of at least 50% from baseline (p=.064), corresponding to a mean difference of 14.7% (95% CI -4.7 to 33.8). None of the patients had a reduction in seizure frequency of 100%. For the CGI-I scale score per caregiver assessment, 48 patients (63%) in the ganaxolone group and 48 patients (44%) in the placebo group were rated as minimally improved or better (OR 1.87, 95% CI 0.89 to 3.91). In the CGI-I scale score administered by the clinician, 48 patients (54%) in the ganaxolone group and 48 patients (42%) in the placebo group were rated as minimally improved or better (OR 1.41, 95% CI 0.68 to 2.94). There were no deaths reported in the study.

Page 19

Overall, this 17-week study concluded that ganaxolone was well-tolerated and safe for the treatment of seizures associated with cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder (CDD) in patients ≥2 years of age; however, statistical analyses of the study results have yet to be published.2 Drug Interactions1: CYP450 inducers - Concomitant use with a strong or moderate CYP450 inducer decreases exposure to ganaxolone, which may reduce the efficacy of ganaxolone.

Concomitant use of ganaxolone with a strong or moderate inducer of CYP450 is not recommended. If ganaxolone must be administered in combination with a strong or moderate CYP450 inducer, a dose increase should be considered not to exceed the maximum recommended dosage.

Alcohol and other CNS depressants - Concomitant use of alcohol or other CNS depressants with ganaxolone may increase the risk of somnolence and sedation.

Adverse Effects1,2: The most common adverse effects of ganaxolone compared to placebo observed in a clinical trial were somnolence (36% vs. 16%), pyrexia (18% vs. 8%), salivary hypersecretion (6% vs. 2%), and seasonal allergy (4% vs. 8%).

Warnings and Precautions1: Use of ganaxolone is accompanied by the following warnings and precautions: somnolence and sedation, suicidal behavior and ideation, withdrawal of antiepileptic drugs.

At the time of this publication, the controlled substance scheduling for ganaxolone is pending.

References:

Dosing : Ganaxolone is available in a 50 mg/mL oral suspension.

Ganaxolone is administered orally 3 times a day with food. The recommended titration schedule and maintenance doses are based on the patient’s body weight. The dose should be titrated based on tolerability, but no more than every 7 days. In patients weighing ≤28 kg, the starting dose is 6 mg/ kg orally 3 times daily (18 mg/kg/ day) titrated weekly to the maximum dosage of 21 mg/kg orally 3 times daily (63 mg/kg/day) by day 22. In patients weighing ≥28 kg, the starting dose is 150 mg orally 3 times daily (450 mg daily) titrated weekly to the maximum dosage of 600 mg orally 3 times daily (1800 mg daily) by day 22. There are no dose adjustments recommended for hepatic impairment. However, patients may require a reduced dose as ganaxolone undergoes clearance via the hepatic route.

1

Administration1: Patients/caregivers should be counseled to shake the bottle well for at least 1 minute and then let the bottle stand for 1 minute. Each dose should be measured using an oral syringe.

Abrupt discontinuation of ganaxolone should be avoided.

Pregnancy and Lactation1: The safety of ganaxolone in pregnant and lactating women has not been assessed in human patients. There are no data regarding ganaxolone use in pregnant women to evaluate for major birth defects, miscarriage, or other adverse maternal or fetal outcomes. In an animal study, oral administration of ganaxolone was shown to have fetal malformations and neurobehavioral and growth impairment.

There are data on the presence of ganaxolone in human milk. Following a single dose of 300 mg, ganaxolone exposure was approximately 4 times higher than those in maternal plasma. This resulted in an estimated daily dose in the breastfed infant of less than 1%.

The effects on the breastfed infant or the effects on milk production are unknown.

Storage1: Ganaxolone should be stored in its original bottle in an upright position, between 15-30⁰C (59-86⁰F). The cap should be kept tightly closed. Unused suspension should be discarded after 30 days of opening the bottle or the “Discard After” date on the bottle, whichever is sooner.

Cost1: At the time of publication, the cost information was not yet available.

Summary/Use in Clinical Practice1-2: CDD is a rare, developmental, and epileptic encephalopathy characterized by refractory seizures that develop within 3 months of birth.

Patients with CDD can have multiple seizures daily with variations of seizure types. CDD-associated seizures are usually refractory to AEDs, thus ganaxolone is the first novel treatment for the treatment of seizures associated with CDD. Ganaxolone was found to be safe and efficacious as a treatment option in patients taking a maximum of three antiepileptic medications.

Author: Chanel Charles-Mwanza, PharmD, is a 2022 graduate of the Campbell University College of Pharmacy and Health Sciences. clcharles0614@email.campbell.edu Page 20

1.

2.

Ganaxolone [package insert].

Marinus Pharmaceuticals, Inc. Radnor, PA; March 2022.

Knight El, Amin S, Bahi-Buisson N, et al. Safety and Efficacy of Ganaxolone in Patients with CDKL5 Deficiency Disorder. Lancet Neurol. 2022; 21: 417-27

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Page 21

Long-Acting Injectables Antipsychotics Quick Reference By: Dr. Charlotte Wilmouth and Dr. Jamie Kilburn Long-Acting Injectables Antipsychotics Quick Reference By: Dr. Charlotte Wilmouth and Dr. Jamie Kilburn

.

Aripiprazole monohydrate2,11-

Fluphenazine decanoate3,1113

Haloperidol decanoate4,11-13

Olanzapine pamoate5,11-13

Aristada, Aristada Initio

Abilify Maintena

Modecate (Brand discontinued)

HALDOL decanoate 50, HALDOL decanoate 100

Zyprexa Relprevv

Indication

Schizophrenia

Schizophrenia, Bipolar I disorder

Psychotic disorders

Schizophrenia

Schizophrenia

Route of Administration

IM

IM

IM or SQ

IM

IM

Injection Site

Gluteal or deltoid (441 mg deltoid only)

Gluteal or deltoid

Gluteal or deltoid

Gluteal

Gluteal

Frequency

Every 4-8 weeks

Monthly

Every 4-6 weeks

Monthly

Every 2-4 weeks

400 mg

6.25-25 mg every 2 weeks until at steady state

10-20 times daily oral dose (max. 450 mg) If initial dose is >100 mg, separate into 2 injections & give remaining dose in 3-7 days

For the first 8 weeks depending on oral dose: 210300 mg every 2 weeks or 405 mg every 4 weeks

No

No

No

No

No

210-1064 mg q 4-8 weeks (dose dependent on frequency chosen) Yes - ,1 dose of 30 mg oral aripiprazole if receiving Aristada Initio 675 mg OR 21 days of oral aripiprazole with 1st Aristada injection

400 mg q 4 weeks (reduce to 300 mg if unable to tolerate) Yes - 10-20 mg oral aripiprazole for 2 weeks after first injection

12.5-50 mg q 4-6 weeks (max 100 mg)

10-15 times the daily oral dose q 4 weeks (max 450 mg)

150-405 mg IM q 2-4 weeks

Yes - Decrease oral dose by 50% after 1st injection, then discontinue after 2nd inj

With oral overlap - 10-20 times the previous daily oral dose x 1 month, then taper by 25% every 4 weeks

No

Generic

Aripiprazole lauroxil1,11-13

Brand

Initial Dose Renal Dose Adjustments Maintenance Dose

Oral Overlap Needed

REMS Required

Missed Doses

441-1064 mg (depending on oral dose)

Brand

Without oral overlap - 20 times the daily oral dose, ↓ decanoate dose by 25% each month during month 2 & 3

No

No

• 6 to ≤ 7 weeks (441mg), • > 8 to ≤ 12 weeks (662 or 882 mg), • >10 to ≤ 12 weeks (1064mg): Give Aristada Initio x1 dose OR 7 days of oral aripiprazole • Less elapsed time: no supplemental dose required • Greater elapsed time: restart initial therapy OR supplement with 21 • days of oral aripiprazole

Generic

13

Aripiprazole lauroxil Aristada, Aristada Initio

Black Box Warnings

2nd/3rd dose: • 4 to < 5 weeks: give dose ASAP • > 5 weeks: restart with 14-day oral overlap ≥ 4th dose: • 4 to < 6 weeks: give dose ASAP • > 6 weeks: restart with 14-day oral overlap

Aripiprazole monohydrate Abilify Maintena

Contraindications

Special Considerations

No

Yes

• ≤ 6 weeks & at steady state: give dose ASAP • 6 weeks to 12 weeks since last dose or steady state not reached: give next dose ASAP, provide oral overlap if symptomatic • ≥ 13 weeks: stabilize on oral antipsychotic, reinitiate LAI

• 2 weeks since last dose and steady state not reached: give dose ASAP and oral antipsychotic for 3 weeks • ≤ 6 weeks and steady state: give dose ASAP • > 6 week and steady state: give dose ASAP and oral antipsychotic for 3 weeks

Fluphenazine decanoate Modecate (Brand discontinued)

Haloperidol decanoate HALDOL decanoate 50, HALDOL decanoate 100

Olanzapine pamoate

Increased mortality in elderly with dementia related psychosis

Hypersensitivity to aripiprazole

Adverse Reactions

No • ≤ 6 weeks & at steady state: give dose ASAP • >6 weeks to 24 weeks since last dose or steady state not reached: give next dose ASAP, provide oral overlap if symptomatic • ≥ 13 weeks: stabilize on oral antipsychotic, reinitiate LAI

Headache, EPS, Weight gain, Injection site pain, QTc Prolongation

EPS, Weight gain, Constipation, Injection. site pain, Sedation, QTc prolongation

Use reduced dose (300 mg) for poor CYP2D6 metabolizer

Hypersensitivity to fluphenazine, severe CNS depression, coma, subcortical brain damage, large doses hypnotics, blood dyscrasias, hepatic disease, <12 years of age EPS, Tardive dyskinesias, Neuroleptic malignant syndrome, Lethargy, Hypertension

Monitor for “silent pneumonia”

Page 22

Zyprexa Relprevv • Increased mortality in elderly with dementia related psychosis • Post injection delirium/sedation syndrome

Toxic CNS depression, Parkinson’s, Lewy Body dementia, hypersensitivity to haloperidol

None listed in U.S. labeling, Hypersensitivity to olanzapine

EPS, Oculogyric crisis, Hematologic abnormalities, Hyperprolactinemia, Seizures, QTc Prolongation

Headache, Sedation, Weight gain, Nausea, Vomiting, Dry mouth, Increased appetite, Orthostatic Hypotension, QTc Prolongation  Observe for 3 hours post injection

Generic Brand

Invega Sustenna

Indication

Schizophrenia, Schizoaffective disorder

Schizophrenia

Schizophrenia

Schizophrenia, Bipolar I disorder

Schizophrenia

Route of Administration

IM

IM

IM

IM

SQ

Injection Site

Starting dose: deltoid Maintenance: deltoid or gluteal

Gluteal or deltoid

Gluteal

Gluteal or deltoid

Abdominal

Frequency

Monthly

Every 3 months

Every 6 months

Every 2 weeks

Monthly

Initial Dose

234 mg on day 1, then 156 mg 1 week later

273-546 mg (depends on previous Sustenna dose)

1092-1560 mg (depends on previous Sustenna or Trinza dose)

25 mg

90 or 120 mg

Renal Dose Adjustments

• CrCl 50 to <80 ml/min: decrease initial and maintenance doses • Not recommended in CrCl <50 ml/min

Maintenance Dose Oral Overlap Needed

Paliperidone palmitate6-8,11-13 Invega Trinza

Invega Hafyera

Risperidone9-13 Risperdal Consta

• Use with caution and reduce dose for CrCl 10 to ≤ 60 ml/min • Not recommended in CrCl <10 ml/min

• Not recommended in CrCl <50 ml/min

• Not recommended in CrCl <90 ml/min

39-234 mg IM every 4 weeks

273-819 mg IM every 12 weeks

1092-1560 mg IM every 6 months

25 mg IM every 2 weeks (↑ in increments of 12.5-25 mg every 4 weeks, max 50 mg/dose)

90 or 120 mg SQ monthly

No

No

No

Yes for 3 weeks after injection

No No

REMS Required

No

No

No

No

Missed Doses

Missed maintenance dose:  4-6 weeks since last dose: give deltoid injection ASAP  > 6 weeks to 6 months: resume same dose ASAP, admin 2nd deltoid inj. 1 week later, then resume monthly dosing  > 6 months: 234 mg deltoid inj. on day 1, then 156 mg deltoid inj. 1 week later, then resume monthly dosing

 3.5 to 4 months since last dose: give dose ASAP  4 to 9 months: re-initiation regimen as defined on package insert  > 9 months: reinitiate regimen with 1 month inj. (Sustenna) for 4 months, then resume every 3 months

 > 6 months & 3 weeks to < 8 months: re-initiation regimen defined on package insert  > 8 months to 11 months: reinitiation regimen defined on package insert  > 11 months: re-initiate after patient treated with 1 month inj. for ≥ 4 months

 2 weeks & steady state not reached: give dose ASAP and oral antipsychotic for 3 weeks  ≤ 6 weeks & steady state: give dose ASAP  > 6 weeks & steady state: give dose ASAP and oral antipsychotic for 3 weeks

Black Box Warnings Contraindications Adverse Reactions

Perseris

• Use with caution in CrCl 10 to ≤60 ml/min • Not recommended in CrCl<10 ml/min

Increased mortality in elderly with dementia-related psychosis Hypersensitivity (anaphylaxis, angioedema) to paliperidone, risperidone, or any component of the formulation Upper respiratory tract infection, Injection site reaction, Weight gain, Headache, Parkinsonism, Dizziness, Extrapyramidal disorder, Tachycardia, Cholesterol disturbances, Drowsiness, QTc Prolongation

Hypersensitivity to risperidone, paliperidone, or any excipients in Risperdal Consta Headache, Parkinsonism, Dizziness, Weight gain, Sedation, Fatigue, Constipation, Dyspepsia, Musculoskeletal pain, QTc Sedation, Weight gain, Agitation, Prolongation Depression, QTc Prolongation

Special Drug interactions with CYP3A4/P-glycoprotein (P-gp) inducers Establish tolerability with oral risperidone Considerations KEY: IM = intramuscular, SQ = subcutaneous, CrCl = creatinine clearance, ASAP = as soon as possible, LAI = long acting injectables, CNS = central nervous system, EPS = extrapyramidal symptoms

Authors: Charlotte Wilmouth, PharmD, 2022 Graduate of Campbell University College of Pharmacy; Jamie Kilburn, Pharm.D., PGY-1 Pharmacy Resident at Harnett Health and CPHS; jkilburn@campbell.edu.

References: 1.

2.

3.

4.

5.

6.

7.

8.

9.

10.

11.

Aristada [package insert]. Waltham, MA: Alkermes, Inc.; 2020.

Abilify Maintena [package insert]. Rockville, MD: Otsuka America Pharmaceutical, Inc.; 2020.

Fluphenazine decanoate [package insert]. Chestnut Ridge, NY: Par Pharmaceutical; 2017.

Haldol decanoate [package insert]. Titusville, NJ: Janssen Pharmaceuticals, Inc.; 2020.

Zyprexa Relprevv [package insert]. Indianapolis, IN: Lilly USA, LLC; 2020.

Invega Sustenna [package insert]. Titusville, NJ: Janssen Pharmaceuticals, Inc.; 2021.

Invega Trinza [package insert]. Titusville, NJ: Janssen Pharmaceuticals, Inc.; 2021.

Invega Hafyera [package insert]. Titusville, NJ: Janssen Pharmaceuticals, Inc.; 2021.

Risperdal Consta [package insert]. Titusville, NJ: Janssen Pharmaceuticals, Inc.; 2019.

Perseris [package insert]. North Chesterfield, VA: Indivior; 2019.

Carpenter J, Wong KK. Long-acting injectable antipsychotics: what to do about missed doses. Current Psychiatry.

2018;17(7):11-18.

12. Parmentier BL. Second-generation long-acting injectable antipsychotics: a practical guide. Current Psychiatry.

2020;19(3):25-32.

13. Keepers GA, Fochtmann LJ, et. al. The American Psychiatric Association Practice Guideline for the treatment of patients with schizophrenia. Am J Psychiatry. 2020;177(9):868-872.

Page 23

NCAP Annual Convention Scientific Poster Presentations 1.

2.

3.

4.

5.

6.

7.

Title: AUC/MIC Vancomycin Dosing Versus Traditional Trough-based Dosing on Initial Therapeutic Concentrations in Obese Patients Authors: Kallie Arthur, PharmD, MBA; Serina Tart, PharmD; Brock Dorsett, PharmD, BCPS; Riley Bowers, PharmD, BCCP, BCPS Presenter: Kallie Arthur Title: Evaluation of Calcitonin for Injection at a Community Hospital Authors: Leslie Barefoot, PharmD, MBA, BCPS Presenter: Leslie Barefoot Title: Quantifying the Effects of Drug Take Back Programs in Two Community Pharmacies Authors: Michael Ferguson, PharmD Candidate, Brittany R. Weger, PharmD Candidate, Elizabeth M. Bickenbach, PharmD Candidate, Jordan Kirby, PharmD Candidate, Desmond Woodburn, PharmD Candidate, Brian Marks, PharmD, Ahunna Freeman, PharmD, BCGP, Travis J. Carlson, PharmD, BCIDP Presenters: Brittany Weger Title: Evaluation of Results of In-Person vs Virtual Visits for Diabetes and Obesity Care Authors: Michelle Chaplin, PharmD, BCACP, CDCES; Haley Clark, PharmD candidate; Megan Triplett, PharmD candidate; Edward T. Chiyaka, PhD, MSc Presenters: Megan Triplett and Haley Clark Title: Assessment of COVID-19 Online Toolkits Created in Collaboration with North Carolina Association of Pharmacists and Campbell University College of Pharmacy; Health Sciences Authors: Kayla Tunehag, PharmD and MSPH Candidate; Abby Cowan, PharmD and MSPH Candidate; Tayler Clark, B.S., PharmD and MSPH Candidate; Emily Steinbock, B.S., PharmD and MSPH Candidate; Dr. Peter Ahiawodzi, PhD, MPH, CPH Presenters: Tayler Clark, Abby Cowan, and Emily Steinbock Title: Impact of a Novel Transitional Care Hybrid Pharmacist Practice Model within a Comprehensive Stroke Center Authors: Heather Dalton, PharmD; Minal Patel, PharmD, BCPS; Meredith Hollinger PharmD, BCPS Presenters: Heather Dalton Title: The Effect of Clinical Pharmacist Interventions Page 52

8.

9.

10.

11.

12.

in Patients with Diabetes Managed on Insulin in an Outpatient Endocrine Clinic Authors: Melissa Dempsey, PharmD, Heather McLeod, PharmD, BCACP, CPP, CDCES, Autumn Mittleider, PharmD, BCACP, BCPS, Erika McClain, PharmD, BCACP, BCPS, CPP Presenters: TBD Title: Evaluating Ambulatory Medication Management for Patients with Emergency Department Visits Due to Hypertension Authors: Tori Taylor, PharmD; Anna Love, PharmD, BCACP; Breanne Wofford, PharmD Candidate; Julia Fabricio, PharmD Candidate; Sarah Darby, PharmD, BCPS Presenter: Julia Fabricio Title: An Analysis of Association Between No-Show Health Visits for In-Person and Telehealth Visits in an Ambulatory Care Setting Authors: Lyndsi Roland, PharmD/MSCR Candidate Class of 2024, Kayla Garris, PharmD/MSCR Candidate Class of 2024, Heather Faulkner, PharmD/ MSCR Candidate Class of 2024, Michael R. Jiroutek, DrPH, MS, Emily Ghassemi, PharmD, MSCR, Melissa Holland, PharmD, MSCR Presenters: Heather Faulkner, Lyndsi Roland, and Kayla Garris Title: Evaluation of Clinical Pharmacist Practitioner Telepharmacy Services for Pediatric Transplant Patients Authors: Austin Gardner, PharmD, MHA; Charissa Kam, PharmD, BCPPS, CPP; Cameron McKinzie, PharmD, BCPPS, BCPS, CPP; Chris Falato, PharmD Presenter: Austin Gardner Title: Evaluation of Vancomycin Dosing in Critically Ill Adults Receiving PIRRT: A Retrospective Cohort Study Authors: Cecily Groves, Lynn Bass, Dustin Bryan, Michael Crawford, Peter Ginn, Melissa Steedly Presenters: Cecily Groves Title: Evaluation of Discharge Antibiotic Prescribing to Improve Antimicrobial Stewardship Upon Hospital Discharge Authors: Amber Johnson, PharmD, Taylor Wells, PharmD, MBA, BCPS, BCACP, Tiffany Kahl, PharmD, BCPS, Serina Tart, PharmD

Presenters: Amber Johnson

20. Title: Impact of In-Person and Virtual Poverty Sim-

13. Title: Evaluation of the Impact of Linked Probiotic

14.

15.

16.

17.

18.

19.

Orders with Broad-Spectrum Antibiotics on Healthcare Facility-Onset Clostridioides Difficile Infection Rates Authors: Tera Jones, PharmD, MSPH; Serina Tart, PharmD; Dustin Bryan, PharmD, BCPS Presenters: Tera Jones Title: Safety and Efficacy of Direct Oral Anticoagulants for Inferior Vena Cava Thrombus Authors: Richard Menear, PharmD Candidate; Jordan Saunders, PharmD Candidate; Afua Faibille, PharmD Candidate; Isaac Hayden, PharmD Candidate; Sarah A. Nisly, PharmD, MEd, BCPS, FCCP; Alexandra E. Mihm, PharmD, BCPS Presenters: Richard “Austin” Menear, Afua Faibille, Jordan Saunders, and Isaac Hayden Title: Impact of Pharmacist Targeted Interventions in the Management of Dyslipidemia in Patients with Coronary Artery Disease Authors: Ivy Nwogu, PharmD, BCPS, Peter Koval, PharmD, BCPS, CPP Presenter: Ivy Nwogu Title: Impact of Pharmacist-Led Discharge Medication Optimization and Reconciliation Program Authors: Halee S. Parham, Pharm D, Taylor Wells, PharmD, MBA, BCPS, BCACP, Heather McLeod, PharmD, BCACP, CPP, Deanna Thompson, PharmD, BCOP, Riley Bowers, PharmD, BCCP, BCPS, Elizabeth Hudson, PharmD, MBA, CPP Presenters: Halee Parham Title: Long-acting Injectable Antipsychotic Utilization and Healthcare Costs Among Adult Medicaid Beneficiaries in South Carolina Authors: Robert L. Bank, Carmela Benson, Dominic Pilon, Charmi Patel, Deepshekhar Gupta, Maya Mahin, Marie-Hélène Lafeuille, Patrick Lefebvre, Brianne Brown Presenter: Brianne Brown Title: A Retrospective Review of Discharge Medication Prescribing Practices in Adult Patients Admitted to an Inpatient Psychiatric Unit for Methamphetamine Induced Psychosis Authors: Meena Mattamana, PharmD, Nicole Whitener, PharmD, BCPS, MBA, Laurie Pennell, PharmD Candidate 2023 Presenter: Laurie Pennell Title: A Review of the Evolution of Natural Product Skin Cleansers And Sanitizers Authors: Savannah Poole, PharmD Candidate, Rodney C. Siwale, PhD., M.S Presenter: Savannah S. Poole Page 53

21.

22.

23.

24.

25.

26.

ulations and the COVID-19 Pandemic on Perceived Empathy in Healthcare Program Students Authors: Savannah Poole, PharmD Candidate, Susan M. Smith, BS, PharmD, BCPS, Edward T. Chiyaka, PhD, MSc, Ryan E. Owens, PharmD, BCPS Presenters: Savannah S. Poole Title: Evaluation of the Relationship Between Use of a Holistic Admissions Scorecard and Academic Performance in First-Year Pharmacy Students Authors: Shanoya Pryce, PharmD Candidate, Tanya Riley, MS, PharmD, BCPS, Susan M. Smith, BS, PharmD, BCPS Presenter: Susan Smith Title: First-Year Pharmacy Student Perceptions of Their Role as Members of the Healthcare Team Authors: Lauren Travis, BS; Susan M. Smith, BS, PharmD, BCPS; Ryan E. Owens, PharmD, BCPS Presenter: Susan Smith Title: Assessment of Student Learning Outcomes from an Interprofessional Education Event on Roles and Responsibilities: A Qualitative Exploratory Study Authors: Kelsey Reivers, PharmD Candidate; Hamza Ahmed, PA-C Candidate; Susan M. Smith, BS, PharmD, BCPS; Shanta R. Dube, PhD, MPH; Ryan E. Owens, PharmD, BCPS Presenter: Kelsey Reivers Title: Development of a Centralized Pharmacy-Run Refill Protocol and Electronic Prior Authorization Program within an Academic Health-System Integrated Care Delivery Model Authors: Jennifer Sato, PharmD, BCPS; Jeffrey Reichard, PharmD, MS, BCOP; Jordan Rush, PharmD, MS; Timothy Weber, RPh, MBA Presenter: Jennifer Sato Title: Impact of Pharmacist-Completed Discharge Follow-Up Phone Calls on 30-Day Readmission Rates in Medicare Patients Authors: Amy Wangerin, PharmD, Autumn Mittleider, PharmD, BCACP, BCPS, Elizabeth Hudson, PharmD, MBA, CPP, Riley Bowers, PharmD, BCCP, BCPS, Taylor Wells, PharmD, MBA, BCPS, BCACP Presenter: Amy Wangerin Title: Comparison of Rates of Initial Supratherapeutic aPTT and anti-Xa Concentrations in Patients Receiving Therapeutic Heparin Infusions Authors: Jennifer Wood, PharmD; Carrie Baker, PharmD, MBA, BCPS; Brock Dorsett, PharmD, BCPS; Riley Bowers, PharmD, BCPS, BCCP; Savannah Knepper, PharmD, BCPS Presenter: Jennifer Wood

NCAP Annual Convention Roundtable Discussion Topics & Descriptions 1. Tobacco Cessation Methods: Combinations of Therapies

injection technique. Stop by to review technique tips and practice with injection training supplies.

Facilitator: Peter Koval Through interactive information exchange, the participants will gain the skills necessary to provide smoking cessation interventions. The abilities of recommending and monitoring nicotine replacement therapies will be emphasized. Details on best practices using the North Carolina 1-800-QUIT-NOW (NC Quitline) in collaborative practice to promote successful and efficient tobacco cessation efforts.

2. Medications for Opioid Use Disorder Facilitator: Mandy Occhipinti In this roundtable, we will discuss what is working in a primary care practice with MOUD (Medications for Opioid Use Disorder) with a pharmacist co-visit with a physician. The discussion will also summarize how a pharmacist fits into opioid use disorder treatment and be successful 3. Syringe Services Program Facilitators: Elizabeth Locklear & Beth Caveness This roundtable will take a step-by-step approach to assist pharmacies in developing policies and procedures to implement a Syringe Service Program in your community. We will go over the state requirements for both services provided and reporting. We will discuss talking points to share with your pharmacy team so that each member of your staff understands what harm reduction is and why it is beneficial for your community.

4. Sharpen Your Skills: Administration of Long-Acting Injectables Facilitator: Abigail Scott Sharpen your injection technique skills! This roundtable will develop your confidence in gluteal and z-track

5. Diversity, Equity, and Inclusion in Recruitment, Hiring, and Retention Practices Facilitator: Carla White Equity is grounded in our ability to address infrastructure and engage in practices to produce a diverse workforce. Addressing systemic challenges that perpetuate inequality and investment in recruitment, hiring, and retention practices can better position the pharmacy profession to accelerate new thinking and ideas in research, education, and practice.

6. How to Evaluate and Determine if Pharmacy Provided Services are Cost Effective in the Hospital and Clinical Setting Facilitator: Lorne Basskin Research in the clinical setting by pharmacists is critical to improving outcomes, learning if processes and interventions are effective, and justifying the value of pharmacy led clinical services. This roundtable will discuss how pharmacists can go about designing and analyzing outcomes research and economic evaluations to determine if pharmacy led interventions are a cost-effective way of treating patients, using specific common examples of clinical services.

7. The Role of a Medical Science Liaison: Trace Amines and Trace Amine-Associated Receptors (TAAR) Facilitator: Judy Curtis Medical Science Liaisons provide valuable educational information to health care professionals. This is demonstrated by bringing information to pharmacists about a new mechanism of disease for serious mental illness. Trace amines and trace amine-associated receptors (TAAR), specifically TAAR1 receptors, are

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potential targets for new treatments for schizophrenia and other mental health disorders. I will discuss trace amines (formerly known as false neurotransmitters), trace amine-associated receptors and their potential role in modulating dopamine, serotonin, and glutamate systems in the central nervous system, olfactory system, and gastrointestinal tract. This discussion will provide introduction to trace amines and trace amine-associated receptors.

8. Medication Therapy Management (MTM) Facilitator: Anna Baird At this roundtable, we will discuss marketing, implementation, and avenues for reimbursement of MTM services in the community pharmacy setting. We will also discuss how to identify different “pain points” for providers to more effectively determine eligible services.

tional materials. The toolkit contains everything your practice will need to implement this program including participant guides, facilitator guides, and slide sets.

11. Ambulatory Care Billing Practices: Success Stories Facilitator: Amina Abubakar Pharmacists are being recognized for the clinical services they offer patients, but this is just the first step.

Recognition must be tied to payment for these services to be sustainable. Medical billing feels like a new language for many pharmacists, but I’m looking forward to shedding light on some of the success stories for pharmacist-provider collaboration and pharmacist-led clinical services to help others navigate payable opportunities for pharmacists.

12. Roadblocks to Billing for Services

9. Transitions of Care Facilitator: Kate Naper A roundtable discussion to connect transitions of care pharmacy providers in acute care, ambulatory or community practice. Topics may include but are not limited to developing best practice and sustainable workflows, measuring outcomes, achieving reimbursement, and how to identify, assess, and resolve barriers to medication access, adherence, and health literacy. Whether you’ve had success in these areas and are eager to share, or are just looking to learn more, please join us!

10. Diabetes Prevention Toolkit Facilitator: Beth Mills & Tara Baran The CDC National Diabetes Prevention Program is a nationally recognized year-long program facilitated by public and private organizations to prevent or delay type 2 diabetes in at-risk patients. Diabetes Free NC aims to remove barriers preventing North Carolinians from participating in these programs due to location or cost. When NCAP was approached to partner in this public health initiative, we considered multiple options and ultimately decided to develop our own shortened version of a diabetes prevention program. This roundtable discussion will introduce you to NCAP’s Diabetes Prevention Toolkit – “A Healthier You” consisting of two patient education sessions and modifiable promo-

Facilitator: Penny Shelton NCAP recently established a Billing Coalition. We also currently have a piece of legislation introduced in the NC General Assembly calling for fair reimbursement for pharmacist-provided patient care services. We know there are legal, operational, technological, and other barriers to billing for services for all practice settings. The purpose of this roundtable session is to gather the details on the barriers to billing, as well as to explore potential solutions.

13. Using Learners More Efficiently as Pharmacist Extenders Facilitator: Macary Marciniak Weck An optimized pharmacy workforce is necessary to advance patient-centered, team-based healthcare and enable individuals to practice at the top of their education, license or registration, and scope of practice.

This roundtable will explore ways to engage student pharmacists, pharmacy technicians and pharmacy residents as integral team members in education and healthcare settings.

14. Fentanyl Test Strips and Pharmacist Training Needs Facilitators: Delesha Carpenter and Baya Ostrach In this roundtable, we present results from a survey of North Carolina community pharmacists’ experiences

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with fentanyl test strips (FTS) and willingness to engage in various activities related to selling and educating about FTS. After a brief presentation of these results, we will actively seek community pharmacists’ preferences for a future FTS training. According to provisional data, an estimated 100,306 drug overdose deaths occurred in the United States during the 12-month period ending in April 2021. The rise in opioid overdose deaths is increasingly attributed to illicitly manufactured fentanyl. As contamination of the drug supply with fentanyl becomes more prevalent, testing tools are required to reduce drug overdose deaths.

FTS are affordable, individually packaged, single-use drug-testing equipment that individuals can use to check for the presence of fentanyl in the substances they use. Given recent local increases in opioid drug overdose deaths attributed to widespread fentanyl contamination, pharmacies are well-situated to increase FTS access.

15. CPESN: Community-led Value-Based Care Facilitator: Ritesh Patel & Tiffany Barber CPESN is a clinically-integrated network of pharmacies that spans across the United States. CPESN NC, is comprised of 260 community pharmacies in NC that have dedicated their practice to providing patient-centered care and incorporating value-based, clinical services in the community pharmacy setting. CPESN pharmacies are involved in several exciting opportunities through partnerships with organizations across the healthcare field. Learn more about what CPESN has to offer and how we can transform community pharmacy by re-focusing on patient-centered services.

16. NC CAN: New Public Health Emergency Communication Initiative Facilitator: Megan Witkowski This roundtable will discuss NCAP’s current work on creating a communication network to help address needs in the public health space pertaining to community pharmacies. North Carolina’s process for communicating during a pandemic, public health emergency, or natural disaster works well for reaching key stakeholders on a macro level. On a micro-level, however, connections between local health departments and the community pharmacies/pharmacists closest to them could be improved. The North Carolina Commu-

nity Pharmacy Alert Network (NC CAN) is designed to improve communication, coordination, and connectivity between local health departments with pharmacies in their designated areas during pandemic, epidemic, outbreaks, natural disasters or other emergencies for the purpose of mobilizing resources and serving residents at the local level, across the state of North Carolina.

17. Identification of Universal Metrics to Monitor for DrugDiversion Surveillance and Controlled Substances Compliance Facilitator: Sheetal Patel-House In 2016, American Society of Health-System Pharmacists (ASHP) published guidelines on the prevention of controlled substances (CS) diversion. These recommendations included development of a comprehensive program to address both surveillance for drug diversion and compliance with CS state and federal laws. Although many metrics are available to achieve these goals, they may not be accessible to healthcare institutions with limited resources. This roundtable will identify a set of universal metrics that can be used to monitor for both drug diversion and CS compliance.

18. Audit-Related Legislative Protections & Complaint Filing Facilitators: Tony Solari Over the years, there have been a number of laws enacted that contain provisions granting certain audit-related protections for pharmacies. This roundtable topic is designed to facilitate discussion regarding how existing audit protections could be better enforced, and to share information regarding audit-related complaint filing and tracking with the NC Department of Insurance.

19. Leveraging Leadership through the NC Association of Pharmacists Facilitator: Carrie Baker During this roundtable discussion, participants will learn about the upcoming leadership opportunities provided by NCAP. Participants will also have the chance to provide suggestions on how NCAP can create and promote leadership development for pharmacists, technicians, and student pharmacists.

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