North Carolina Pharmacist Volume 102 Number 2 Spring 2021
Advancing Pharmacy. Improving Health.
Official Journal of the North Carolina Association of Pharmacists ncpharmacists.org
Official Journal of the North Carolina Association of Pharmacists 1101 Slater Road, Suite 110 Durham, NC 27703 Phone: (984) 439-1646 Fax: (984) 439-1649
www.ncpharmacists.org EDITOR-IN-CHIEF Tina Thornhill 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 EXECUTIVE DIRECTOR Penny Shelton PRESIDENT Beth Mills PRESIDENT-ELECT Matthew Kelm PAST PRESIDENT Dave Phillips TREASURER Ryan Mills SECRETARY Paige Brown Kevin Rhash, Chair, SPF Tyler Vest, Chair, NPF Anna Armstrong, Chair, Community Angela Livingood, Chair, Health-System Janine Bailey, Chair, Chronic Care Irene Ulrich, Chair, Ambulatory Ouita Gatton, At-Large Vinay Patel, At-Large Riley Bowers, At-Large North Carolina Pharmacist (ISSN 0528-1725) is the official journal of the North Carolina Association of Pharmacists. An electronic version is published quarterly. The journal is provided to NCAP members through allocation of annual dues. Opinions expressed in North Carolina Pharmacist are not necessarily official positions or policies of the Association. Publication of an advertisement does not represent an endorsement. Nothing in this publication may be reproduced in any manner, either whole or in part, without specific written permission of the publisher.
North Carolina Pharmacist Volume 102 Number 2
Spring 2021
Inside • From the President .....................................................................................3 • 2021 NCAP Convention Was A Success!................................................................5 • Awards..................................................................................................................6 • Sponsors and Exhibitors .........................................................................................8 • Scientific Posters.............................................................................................9 • Avoid Federal Law Violations..............................................................................25 • New Drug Monograph - Verquvo...........................................................................20 • Member Spotlight................................................................................................31 • Reflections of the COVID-19 Pandemic.......................................................33 • New Drug Monograph - Ponesmiod.......................................................................20
Click Here to Keep in Touch North Carolina Pharmacist is supported in part by: • Pharmacy Quality Commitment .......................................................23 • EPIC Pharmacies Inc .........................................................................24 • Pharmacists Mutual Companies .......................................................26 • Pharmacy Quality Commitment .......................................................30 • Pharmacy Technician Certification Board .......................................32 • VUCA ...................................................................................................34 • Your Community Health Plan ............................................................36 • NCAP Career Center ..........................................................................41 • VUCA ...................................................................................................43 CORRECTIONS AND ADVERTISING For rates and deadline information, please contact Rhonda Horner-Davis at rhonda@ncpharmacists.org
•From the Executive Director• Penny Shelton, PharmD, BCGP, FASCP
Legislative Process: A New Olympic Sport?
If you’ve been paying attention, and hopefully you have; then you know that we have been embroiled in a difficult legislative session. To partially draw from a Winston Churchill quote, there have been “tears, toil, and sweat”, in spades. When Churchill spoke these words, in his first address, as Prime Minister, to the House of Commons, England was at war, and Churchill had the daunting task of rallying their nation. Obviously, NCAP is not at war, but make no bones about it, we are currently in a legislative battle here at home. I am not going to go into the details of each of the pieces of legislation that we are working on in the General Assembly; for this information, I will refer you to our Legislative & Policy Update newsletters. Instead, I want to focus on a few lessons learned in our battle for greater authority for pharmacists, and better access to care for patients. Many of you are anxiously awaiting the airing of the Summer Olympics in Tokyo. Playfully, I couldn’t help but think about political competition, and if our legislative process was an Olym-
pic sport, what would it entail? Perhaps to spectators, it would look something like the combination of a marathon, hurdles and intermittent sprints, with a several rounds of boxing, and an occasional long jump thrown in. Similar to every competitive athlete, primary bill sponsors (legislators), have a strategy for how they will compete, or in our case, run our bills. Sometimes, while ‘the race’ is being run, they have to adjust their strategy. At times bills move very quickly, other times very slowly, worse case no movement at all. I, not unlike many of our members, can become impatient with the process, or befuddled by the suddenness of scheduling before a committee. Essentially, we want things to make sense. We want victory. We want our bills passed. We want success!
Therefore, the first take-away, or lesson learned, is to not lose patience; remember the process is a marathon, an ordeal, a battle. Equally important, is to not let the slowness of the process steal your enthusiasm for the issue. As time passes, we can become disengaged, our voice goes silent. We cannot let this happen, not with what we have on the line. Our issues are too important! Page 3
Every bill has to clear a number of committees. These committees are the ‘hurdles’ in the strange-but-weirdly stated Olympic sport analogy. The boxing rounds represent the battle that happens with groups who are partially or fully opposed to the bill. Compromise occurs throughout, and the give and take leads to successes and failures all along the way. We enter with a bill that outlines what we want and think is best; but in navigating the lengthy legislative process, it is rare to end up with everything we want. The second take-away, or lesson learned is to celebrate our gains in the process, and view the losses as opportunities, instead of failures. We may not get everything that we seek, but our experience with each bill can help us identify better strategies and tactics for future attempts. As an example, we knew it was important to have legislators, who are members of the party in power, and who are also chairpersons for issue-relevant committees, to serve as our primary sponsors. However, we have learned during this session, that it is equally important, to select primary sponsors who are passionate about the bill issue; because if they are, then they will work hard to bring
the opposition to the table for open discussion, and they will work hard to garner support for the bill. It is not enough that a legislator be willing to introduce a bill for us, we need legislators willing to go to battle for us.
I am currently reading the book “Nine Lies About Work” by Marcus Buckingham and Ashley Goodall. There’s a chapter in the book that addresses all the business hyperbole related to failure. When I read the following, I immediately thought about what we, as an Association, are experiencing in this ‘marathon’ of a ‘battle’ with our bills. They wrote: “success is the aggregation of small successes, and … improvement consists of finding out what works, seizing hold of it, and figuring out how to make more of it.” We entered this legis-
lative session with five bills. We will likely not get all five across the finish line; however, we will continue to sweat and toil, giving our best to do so. We also know that for the bills we do get across the finish line, the end result, when compared to the original bill, may look quite a bit different. When we emerge from this legislative session, albeit a bit bruised, but wiser, I can assure you that NCAP will have a number of victories and successes to celebrate with pharmacists and pharmacy technicians; furthermore, the lessons learned will better position us to ‘make more of it (i.e., success)’ down the line. All I ask is that you:
• Maintain your NCAP membership so we can keep you informed and keep fighting for
'OUR STATE' PHARMACY SUMMIT
On August 11th, NCAP will host thought leaders from across the state to discuss current workforce and work environment issues in the context of patient safety and advanced roles for pharmacists and technicians.
We need more data from community pharmacists!
Scan the QR code to the right to complete a quick survey regarding your workplace environment as a community pharmacist.
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the profession.
• Respond to legislative alerts when we ask for you to call or write certain committee members, or your legislators. We only do alerts when it is super important for member engagement.
• Thank the legislators that are working hard for us. We tell you who to thank in our Legislative & Policy Update newsletters and emailed alerts. It is important for these legislators to hear from our members. If they are successful now, then we want to have them run future bills for us. They will be more likely to go to battle for us again, if they know our members are grateful for their support and service. As always, ‘Pharmacy Proud’, Penny
NCAP’s 2021 Virtual Convention was a Success!
Although this year’s convention was a virtual event once again, it was a success. The convention offered 39.5 hours of live/contact ACPE accredited CE hours. This was the first time we had all four academies together in one meeting, and Convention truly had something for everyone. The planning committee did a phenomenal job of creating a wide variety of content and securing exceptional speakers. The NCAP staff would like to extend a heartfelt ‘thank you’ to the committee, speakers, moderators, poster presenters and EVERYONE involved in planning and presenting this event. It was a huge undertaking, and we are very proud of the results. We also would like to say ‘congratulations’ to this year’s award recipients. Please, take a moment to see your colleagues who were selected as this year’s recipients in this edition of North Carolina Pharmacist. Also, in this edition, you will see the 27 submitted abstracts that were selected to present during our convention’s poster session platforms. There is a lot of wonderful research going on right here in North Carolina; take time to see for yourself. We wish we
could have met in person, but venue contracts for an event of this size have to be secured approximately one year ahead of time, and large in-person meeting restrictions had not been lifted in time for us to do so. Therefore, our planning committee, staff and executive leadership team made the decision to create a very robust program in a virtual format. We look forward to actually seeing everyone in person at the 2022 Convention June 9th and 10th at the Benton Convention Center in Winston-Salem, NC! More details will be shared as they become available, but we just wanted to give you something to look forward to and it will be here before you know it.
Please, note if you registered for convention, we have repackaged as many sessions as we could and have made them available on our website for on-demand learning. This is included in your registration fee you paid. These on-demand sessions will be considered non-live/non-contact NC CE.
2021 Annual Convention Now on Demand Until August 1st, 2021 The theme for this year’s convention was “Stronger Together – Many Paths – One Mission.” With more than 39 hours of academy-specific content, we recognize that many convention-goers may have missed valuable programming. Don’t worry, we’ve got you covered! Available now until midnight, July 31st, 2021, NCAP is excited to offer all convention registrants access to an on-demand list of recorded sessions from our live events. Click here for more information! Page 5
2021 NCAP Award Recipients
Excellence in Innovation
Distinguished Young Pharmacist
Claire Austin, PharmD
Tyler Vest, PharmD
Bowl of Hygeia
McKesson Leadership Award
Mollie Scott, PharmD
Matt Kelm, PharmD
NCPA Leadership Award
Dale Jones Memorial Award
Matt Kelm, PharmD
Judith Jones Turnage, PharmD
Don Blanton
Chronic Care Pharmacist of the Year
Peter Koval, PharmD
Cecil Davis, PharmD Page 6
Technician of the Year
Health-Systems Pharmacist of the Year
Alison Walker, BS, CPhT
DeAnne Brooks, PharmD
Community Care Pharmacist of the Year
Technician of the Year
Elizabeth Caveness, PharmD
Ashley Rogers, CPhT – Adv
Ambulatory Care Pharmacist of the Year
Student Pharmacist of the Year
Autumn Steen, PharmD
Kayla Tunehag
President’s Service Award ASHP Leadership Award
Cortney Mospan, PharmD (Left)
Dustin Wilson, PharmD (Middle)
Angela Livingood, PharmD
Katie Trotta, PharmD (Right)
NCAP President’s Award Beth Mills, PharmD
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2021 NCAP Sponsors and Exhibitors
Platinum Sponsors
Gold Sponsors
Silver Sponsor
Bronze Sponsor
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2021 NCAP Scientific Posters
Title: Identifying barriers to utilization of a medication access program among referred patients surveyed after discharge from an acute care hospital
Authors: Paige E. Greene, T. Wells, A. Wright, J. Wood, J. McLellan, R. Bowers, J. Angell, E. Hudson, M. Pitt
Background/Purpose: For uninsured residents of select counties in North Carolina, the Cumberland County Medication Access Program (CCMAP) provides prescriptions at no cost. Uninsured patients hospitalized at Cape Fear Valley Medical Center are referred to CCMAP at discharge by Cape Fear Valley Health System employees, primarily Coordination of Care personnel and Outpatient Pharmacy personnel. The purpose of this study is to describe the most frequently reported utilization barriers among surveyed patients referred to CCMAP following discharge from Cape Fear Valley Medical Center. Methods: This is a single-center, survey-based, descriptive research study. Referring Cape Fear Valley Health System employees collected the Medical Record Number (MRN) of patients referred to CCMAP at discharge between 10/22/2020 and 12/31/2020. These patients were contacted by a research team member via telephone at least 30 days after discharge to
voluntarily participate in a survey regarding their ability to receive prescriptions from CCMAP after discharge. Patient reported utilization barriers and demographics were recorded. A similar survey was voluntarily completed by referring Health System employees. Employee reported utilization barriers were collected to identify discrepancies in perceived utilization barriers among discharged patients and referring Health System employees.
Results: There were 69 patients referred to CCMAP at discharge by Outpatient Pharmacy personnel. A total of 17 patients met inclusion criteria and completed the survey. Of these, 35.29% of patients reported their greatest utilization barrier to be uncertainty about how to apply for CCMAP. Additionally, 25 surveys were completed by referring Outpatient Pharmacy personnel. Of these, 56% of participants reported they believe the greatest utilization barrier to be patient uncertainty about how to apply for CCMAP. Conclusions: Uninsured patients discharged from Cape Fear Valley Medical Center could benefit from increased assistance with completing CCMAP applications and enrollment with the program prior to discharge in order to improve continuity of care. •••••••••••••••••••••••••••••••• Page 9
Title: Benefits of utilizing pharmacy learners in an inpatient anticoagulation education service Authors: Carrie Baker, PharmD, MBA, BCPS; Emily Ghassemi, PharmD, MSCR, BCACP, CDE, CPP; Riley Bowers, PharmD, BCCP, BCPS Institution: Cape Fear Valley Medical Center, Fayetteville, NC; Campbell University College of Pharmacy & Health Sciences, Buies Creek, NC
Objective. The 2019 Hospital National Patient Safety Goal 03.05.01 indicates education regarding anticoagulant therapy should be provided to patients and families. Previous studies assessing pharmacist and pharmacy learner involvement in oral anticoagulation (OAC) education services have focused on patient-related outcomes, with limited emphasis on the additional benefit to the learner. The purpose of this study was to assess the benefit of pharmacy learner involvement in anticoagulation education services both clinically and through their perceptions of participating in the service. Methods. This prospective cohort study utilized assessments of both learners’ knowledge and perceptions of providing OAC education before and after a 1-month learning experience, where students provided counseling 2-3 days per
week. The primary endpoint was comparing each learners’ pre and post OAC education knowledge assessments. Secondary endpoints included perceived benefit of learner participation in the service, percentage of patients able to recall the counseling session and information provided, and number of interventions made related to inappropriate OAC therapy. Results. A total of 35 pharmacy learners were included in this study with 277 patients receiving counseling, and 40 interventions made related to inappropriate therapy from June 2020 through March 2021. The mean pharmacy learner score improved significantly (21.52%) between pre-assessment and post-assessment, 48.67% vs. 70.19% respectively (95% CI 0.178 to 0.252, p<0.0001). Pharmacy learners also indicated a statistically significant change in perceptions related to their patient counseling abilities. Additionally, 124 patients who received counseling were able to be contacted following hospitalization, 90.32% were able to recall the medication and indication, and 87.9% found the counseling useful. Conclusion. Pharmacy learner participation within anticoagulation education services significantly improved learner knowledge and confidence in their counseling abilities. It also allowed for over 70% of patients to successfully recall pertinent information about their anticoagulants over a week later and improved patient care through dosing interventions.
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Title: Cost Analysis of Direct Oral Anticoagulant Rivaroxaban versus Enoxaparin for Prophylaxis of Ve-
nous Thromboembolism in Acute Medically Ill Patients
Authors: Phoenix Riley (PharmD, MSc Candidate), Meredith Lilley (MSc, DHSc Candidate), Faculty Advisor: Dr. Charles Carter, PharmD, MBA Objectives: Acute medically ill patients are at high risk for venous thromboembolism (VTE). Subcutaneous enoxaparin is the ‘gold’ standard therapy in these patients. Recently, one direct oral anticoagulant has been approved for this indication by the FDA; rivaroxaban (2019). The aim of this study was to perform a cost analysis of rivaroxaban versus enoxaparin for VTE prophylaxis.
Methods: Cost estimates of rivaroxaban and enoxaparin were obtained from publicly available sources (CMMS, Drugs.com). Cost estimates for clinical outcomes were garnered from literature and public databases (CMMS). Data from a key trial (rivaroxaban: MAGELLAN) was utilized to determine probabilities of potential clinical outcomes. A decision tree model was constructed (TreeagePro®) for analysis of the therapy relative to enoxaparin. Doses/ regimens were consistent with approved labeling. Costs were reported in 2019 United States currency (USD) and the study was performed from a societal perspective. Discount rate was 5%. Monte Carlo (probabilistic sensitivity) analyses was performed. Results are expressed as expected value (EV) or the average cost for each treatment strategy. Two-way sensitivity analyses using 50% to 200% of the key VTE clinical outcomes was performed. Results: The EV for the comparison of enoxaparin to rivaroxaban favored enoxaparin ($1,271 versus $1,650; 22.3% difference). Page 10
Conclusions: In acute medically ill hospitalized patients at risk for VTE, the EV of enoxaparin was more optimal than rivaroxaban based upon clinical trial results. These results are valuable in guiding effective clinical decision making and assessments for formulary inclusion. As further clinical outcome data becomes available, it is recommended that similar analyses be repeated to better model real-world settings. ••••••••••••••••••••••••••••••••
Title: Acute liver injury following exposure to sulfamethoxazole/ trimethoprim Authors: Sarah Wise, PharmD/ MSCR Candidate Class of 2022, Rebekah Sowers, PharmD/MSCR Candidate Class of 2022, Avishek Nagi, Statistical Advisor, Dr. Melissa Holland, PharmD, MSCR, Dr. Ayako Suzuki, MD, PhD
Institution: Campbell University College of Pharmacy & Health Sciences, Buies Creek, NC, Department of Medicine, Durham VA Medical Center, Durham, NC
Objective: Drug-induced liver injury, although rare, is the leading cause of acute liver failure and has been associated with a variety of medications. The Veterans Health Administration (VHA) Drug-Induced Liver Injury Database Project applied new approaches to identify acute liver injury events following drug exposures using the electronic medical records (EMR). The purpose of this study was to utilize those approaches to deduce acute liver injury incidence associated with sulfamethoxazole/trimethoprim (SMZ/TMP) in the real world, as well as to identify risk disparities pertaining to age, gender, and race/ethnicity.
Methods: This study was a retrospective cohort analysis of data collected via the VHA EMR during the years 1999-2015. Incidence of acute liver injury, defined by laboratory data, following exposure to SMZ/TMP was computed and analyzed for the association with demographic characteristics using multiple logistic regression models.
Results: Approximately 900,000 patients were exposed to the study drug SMZ/TMP. For SMZ/ TMP exposed patients, most patients were male (88.8%), greater than 66 years of age (66.6%) and white (68.7%). Acute liver injury incidence for SMZ/TMP was 0.28% (95% confidence interval 0.27–0.29). In the multiple logistic regression, men and American Indian or Alaska Native were more likely to develop acute liver injury following SMZ/TMP. Conclusion: This study demonstrated high rates of acute liver injury following SMZ/TMP in comparison to prior literature. Risk disparities were found in acute liver injury following the exposure to SMZ/ TMP. A better understanding of risk disparities for SMZ/TMP will allow for more informed prescribing decisions and monitoring for future patients.
Objective: Limited data exists on the physicians’ perceptions of clinical pharmacists in the United States. In North Carolina, pharmacists can enter into collaborative practice agreements with physicians, allowing them to assume responsibility for patient care services that would normally be beyond their scope of practice. However, this type of collaboration will only be successful if each side sees the value that the other provides to the team and knows of the services that they can provide. The purpose of this study is to identify gaps in understanding of clinical pharmacy and opportunities to increase interprofessional collaboration. Methods: This was a descriptive survey cohort study. The primary objective was to describe perceptions of clinical pharmacy services among medical residents. The secondary objectives were to describe the percentage of medical residents that have access to clinical pharmacy services and to compare the knowledge of available clinical pharmacy services by medical residents versus actual services provided as reported by pharmacists.
Results: Forty-one medical residents in North Carolina •••••••••••••••••••••••••••••••• completed the survey. Of these, 41.5% attended a private medTitle: Perceptions and Knowledge ical school with 75.6% have an of Clinical Pharmacy Among Medi- MD degree. Majority of residents cal Residents in North Carolina (58.5%) were a PGY3 or higher. Family medicine and emergenAuthors: Payton Tipton, PharmD; cy medicine residents were the Riley Bowers, PharmD, BCCP, most represented with 26.5% BCPS; Autumn Mittleider, PharmD, in each. One-hundred percent of BCPS, BCACP, CPP; Heather residents felt that pharmacists O’Brien, PharmD, CPP; Erika Mcwere important or very important Clain, PharmD, BCACP, BCPS, CPP in answering drug information questions, while only 25% felt Institution: Cape Fear Valley that pharmacists were important Health System, Fayetteville, NC in vaccine administration. At least 50% of medical residents were aware of all pharmacy services Page 11
available except for transitions of care, vaccine administration, and medication cost assistance.
Conclusion: Medical residents find pharmacist involvement to be most important in answering drug information questions. There is a continued need for education of medical residents on availability of pharmacy services. ••••••••••••••••••••••••••••••••
Title: Acute liver injury following exposure to ciprofloxacin
Authors: Rebekah Sowers, PharmD/MSCR Candidate Class of 2022, Sarah Wise, PharmD/MSCR Candidate Class of 2022, Avishek Nagi, Statistical Advisor, Dr. Melissa Holland, PharmD, MSCR, Dr. Ayako Suzuki, MD, PhD Institution: Campbell University College of Pharmacy & Health Sciences, Buies Creek, NC; Department of Medicine, Durham VA Medical Center, Durham, NC
Objective: Acute liver injury following drug exposure, although rare, is the leading cause of acute liver failure and has been implicated with a variety of medications. The Veterans Health Administration (VHA) Drug-Induced Liver Injury Database Project engineered new approaches to identify acute liver injury events following drug exposures using electronic medical records (EMR). The purpose of this study is to utilize those approaches and deduce acute liver injury following ciprofloxacin exposure in the real world, as well as to identify risk disparities in acute liver injury incidence among age, gender, and race/ethnicity. Methods: This study was a retrospective cohort analysis of data collected from the VHA EMR
during the years 1999-2015. Incidence of acute liver injury, defined by laboratory data, following exposure to ciprofloxacin was computed and analyzed for association with demographic characteristics using multiple logistic regression models.
Results: Approximately 1 million patients were exposed to ciprofloxacin between 1999 and 2015. Patients were mostly male (91.8%), greater than 66 years of age (72.8%), and white (69.7%). Acute liver injury incidence for ciprofloxacin was 0.41% (95% confidence interval 0.40–0.42). According to the multiple logistic regression, men, the black race group, as well as age groups 46-55 and 56-65 are more likely to develop acute liver injury following ciprofloxacin exposure. Conclusion: This study demonstrated higher incidence of acute liver injury following ciprofloxacin use compared to prior literature assessing other medications. Significant risk disparities in acute liver injury incidence were identified among study subgroups following exposure to ciprofloxacin. Understanding these risk disparities for ciprofloxacin will allow for more informed prescribing decisions and monitoring for future patients. •••••••••••••••••••••••••••••••• Title: Evaluation of Pharmacist-Led Behavioral Health Interventions to Improve Glycemic Control in Patients Managed by Atrium Health Internal Medicine Providers Authors: Garfinkle, S. Nagy, K. Carson, P. Burleson, C. Cole, J. McKnight, K. Skaff, L. Wilkins, N.
Institution: Atrium Health Cabarrus PGY1 Pharmacy Residency
in the Ambulatory Care Setting; Concord, North Carolina
Objective: The primary objective of this study is to evaluate the impact of pharmacist-driven telehealth services on antidepressant management in high-risk patients with the comorbid condition of diabetes. Methods: This was a prospective, investigator-initiated pilot study conducted at 4 Atrium Health Cabarrus Internal Medicine sites. Eligible patients were gathered from Cerner/Powerchart based on ICD10 diagnosis codes congruent with diabetes, depression, and/or anxiety and with an A1c > 9%. Participants were excluded if they were under management by a private psychiatrist or Atrium Health’s Behavioral Health Integration Services. • Chart reviews were completed to assess drug-drug interactions, antianxiety/antidepressant medication regimen, diabetes medication regimen, and baseline labs/ screening tools. • Initial telehealth visits were conducted by the pharmacist to establish baseline, assess medication adherence and tolerance, and determine areas for intervention. • Recommendations were proposed to managing providers and implemented by pharmacist if approved. • Follow up telehealth visits were completed every 3-4 weeks and medications were adjusted as needed.
Results: Thirty-one patients were enrolled from December 2020 through March 2021. The majority of patients were followed through final hemoglobin A1c collection. While not finalized, results indicate significant improvement in A1c with pharmacist-led behavioral health and diabetes Page 12
management interventions.
Conclusion: Mood disorders tend to be overlooked when assessing barriers to achieving glycemic control in patients with diabetes mellitus. The utilization of a pharmacist in a setting that allows for observation and monitoring of anxiety or depression management can lead to improved diabetic outcomes and quality of life. ••••••••••••••••••••••••••••••••
Title: Evaluation of direct oral anticoagulant (DOAC) to heparin transition strategy in the inpatient setting Authors: Sonam Patel, PharmD; Tina Hipp, PharmD, BCPS; Bobby Poplin, PharmD
Institution: Atrium Health Cabarrus, Concord NC
Objective: The purpose of this evaluation is to determine the current strategy being used at Atrium Health Cabarrus for transitioning patients from DOAC to therapeutic dose heparin in the inpatient setting and to assess its associated safety and efficacy. Methods: The Institutional Review Board at Atrium Health Cabarrus approved this retrospective chart review as a quality improvement project. Data was collected on adult patients who were transitioned from DOAC to therapeutic heparin between May 2020 to October 2020 and stored using the REDCap data collection tool. The primary outcomes of this evaluation include the reason for DOAC to heparin transition and the time between last DOAC dose and heparin initiation. Secondary outcomes include achievement of therapeutic aPTT and incidence of major bleeding and/or thromboembolic events.
Data from this evaluation was analyzed using descriptive statistics. Results: 52 of 132 patients screened met study inclusion criteria. Most patients were Caucasian males with an average age of 66 years. 52% of patients were transitioned to heparin in the setting of an upcoming procedure. The remaining patients were transitioned due to renal dysfunction (13%), NPO status (8%), or for other indications (27%) such as NSTEMI or acute thrombosis. Among those with clearly charted dose times, the average time to heparin initiation was 20.6 hours [median(IQR) = 14.8 (9-27.3)]. Therapeutic aPTT was achieved in 50% of patients. Bleeding occurred in 3 patients and thrombotic events occurred in 5 patients. No deaths due to anticoagulation were observed.
Conclusion: This evaluation was unable to identify a consistent strategy being utilized by providers at Atrium Health Cabarrus with regards to the timing of heparin initiation. In most patients, heparin was initiated within 20 hours of the last DOAC dose. Despite inconsistencies with timing, bleeding and thrombotic events showed no clear association with early or delayed heparin initiation, respectively. ••••••••••••••••••••••••••••••••
Title: Pharmacist-Led Medication Reconciliation Process Improvement in a Community Hospital General Medicine Unit Authors: Benjamin Tutterow, Dustin Bryan, Susan Canady, Melissa Steedly, Savannah Knepper Institution: Cape Fear Valley Medical Center, Fayetteville, NC
Objective: The primary purpose of this study was to determine the impact of a pharmacist-led medication reconciliation service for hospitalized patients on an internal medicine floor at a community hospital. This was determined by quantifying the number of interventions made during the medication reconciliation process. Secondary objectives were to further describe the types of interventions made, to describe the cost avoidance associated with these interventions, to describe the provider acceptance rate of these interventions, and to describe the amount of time required to complete the medication reconciliation process.
Methodology: Participants included in this study were adults 18 years of age and older admitted to a general medicine unit. Included adult patients were admitted for 72 hours or less during the study period from October 1 to October 31, 2020 taking at least one scheduled medication prior to admission. The primary endpoint was the number of interventions related to medication reconciliation events conducted by a pharmacist. Secondary endpoints were types of interventions performed, amount of cost avoidance associated with each intervention, amount of time required to perform the medication reconciliation, and percentage of accepted interventions. Descriptive statistics were used to analyze the data of this study.
Results: 17 total interventions were performed and accepted over the study period involving 3 intervention subtypes; drug/disease (5), drug/dose (4), and drug/ drug (1). Overall cost avoidance was $19000, mean time to perform the medication reconciliation was 21.2 minutes, and 58.8% of interventions were accepted. Page 13
Conclusions: Pharmacist-led medication reconciliation resulted in few interventions, likely due to the study location and efficient emergency department pharmacy technicians. An inadvertent benefit in staff pharmacist workflow resulted from the use of documentation strategies developed in study. ••••••••••••••••••••••••••••••••
Title: Improving the Transitions of Care from Intensive Care Unit to Step Down Unit Using Pharmacist Review
Authors: Andrea Lippucci, PharmD, Mike Maccia, PharmD, BCPS, BCCCP, Wesam Yacoub, MD, Randy Absher, PharmD, BCPS Institution: Moses Cone Memorial Hospital, Greensboro, North Carolina
Objective: To assess the impact of a clinical pharmacist’s review of medications at transfer from the intensive care unit (ICU) to assist with discontinuing select medications that were started for temporary indications during acute illness. This objective was measured with a primary outcome of total number of medications continued without an indication in both a retrospective and intervention cohort. Secondary outcomes assessed the primary outcome for each specific medication class and overall hospital length of stay. Methods: This IRB approved prospective case-control study with intervention arm was conducted in two medical ICUs in a community teaching hospital from September to December 2019 (retrospective) and September 2020 to January 2021 (prospective). Clinical pharmacists working in the ICU were educated on the
focus medications and possible interventions. Focus medication classes include antipsychotics/ anticonvulsants, opioids, benzodiazepines, stress ulcer prophylaxis agents, antibiotics, and steroids. When the intensivist suggested a patient would be transferred, the clinical pharmacist suggested discontinuing or tapering the focus medications no longer indicated.
Results: Both cohorts included 35 patients. The average patient was 55 years old, male, and had a past medical history significant for diabetes or COPD/asthma. Within the control group, 29 medications for 18 patients were continued without an indication at transfer. In the intervention arm, 3 medications were continued without an indication in 2 patients (p <0.001). There were statistical differences in the number of opioids (p=0.01), stress ulcer prophylaxis agents (p<0.001), and antibiotics (p=0.039) inappropriately continued. There was no statistical difference in continuation of antipsychotics, anticonvulsants, benzodiazepines, or steroids.
Kilburn J, Malloy V, Thakkar D, Crawford M, Bowers RD
Institution: Cape Fear Valley Medical Center—Fayetteville, NC
Background/Purpose: Antimicrobial stewardship efforts in the emergency department (ED) are generally focused towards the inpatient setting. As half of outpatient medical care occurs in emergency departments, we sought to implement an outpatient-focused antimicrobial stewardship effort. The aim of this study was to evaluate the impact of a prescription review process on improving appropriate empiric antibiotic prescribing at discharge from the ED at a community hospital.
Methodology: In October 2020, a prospective discharge antibiotic prescription review process was implemented in the ED. Discharge antibiotic prescriptions were routed to the ED pharmacist verification queue and evaluated based on patient-specific parameters and current infectious disease guidelines. When prescribing issues were identified, the prescriber was contacted with new Conclusion: A pharmacist’s recommendations. A review was review of medication lists before implemented to analyze prescriptransferring from the ICU can yield statistically significant differ- tions for two months before the ences in discontinuation or de-es- new service implementation and two months after. Prescriptions calation of therapy, specifically with opioids, stress ulcer prophy- that met initial screening critelaxis agents, and antibiotics. These ria during each timeframe were results align with previous studies randomly selected to include showing reduction of inappropri- 260 prescriptions in each group. The primary endpoint was rate ate medication continuation at of appropriate empiric antibiotic transfer from the ICU. prescriptions based on indication, •••••••••••••••••••••••••••••••• drug, dose, and duration. Time in the emergency department and 30-day revisit rates were also Title: Impact of discharge antibiotic prescription review on appro- compared between the groups. priate empiric antibiotic preResults: The implementation of scribing in a community hospital a prospective prescription review emergency department process significantly increased the number of appropriate antibiotic Authors: Felmer AC, Simpson H, Page 14
prescriptions compared to before the service (80.0% vs. 58.4%, p <0.0001). Each component of the primary endpoint was also significantly increased with the exception of appropriate antibiotic based on patient-specific factors. Patient time in the emergency department was not extended by the implementation of this new service as the mean time spent in the ED before the service was 244.2±282.0 minutes compared to 215.2±179.6 minutes after (95% CI [-69.81 to 11.84], p=0.1636). Conclusions: A prospective prescription review process was effective in increasing the rate of appropriate antibiotic prescriptions written for patients discharging from a community hospital ED without increasing the duration of visit.
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Title: Impact of Curbside Warfarin Monitoring on Appointment Attendance and Patient Satisfaction at an Urban Outpatient Clinic during the COVID-19 Pandemic
Authors: Kathleen Macalalag, PharmD1,2, Carrington Royals, PharmD Candidate 20212, Jessica King, PharmD Candidate 20212, Autumn Mittleider, PharmD, BCACP, BCPS, CPP1,2, Erika McClain, PharmD, BCPS,BCACP, CPP1,2 Institution: Cape Fear Valley Health, Fayetteville NC; Campbell University College of Pharmacy & Health Sciences, Buies Creek NC Objective: The primary purpose of our study was to compare patient attendance at warfarin monitoring appointments prior to and following the implementation of our curbside INR service. Secondary objectives were
to identify any relationship(s) between the number of comorbid conditions that increase risk of severe infection with COVID-19 and attendance at warfarin monitoring appointments during the COVID-19 pandemic, to describe patient satisfaction with our curbside service, and to describe patients’ perceptions of length of curbside warfarin visits compared to in-clinic warfarin visits. Methods: This single-centered, historical control study included patients of a family medicine clinic that completed at least one pharmacist-managed curbside INR visit between April 1, 2020 to September 30, 2020. Patients that declined to complete our survey, were not on warfarin therapy, or were missing data necessary for the primary endpoint were excluded. Data collected included patient demographics, indications for warfarin, conditions that increase risk of severe infection with COVID-19, number of warfarin appointments scheduled/canceled, and survey responses.
Results: Prior to implementing a curbside INR service, 9.1% of forty-two patients canceled warfarin monitoring visits compared to 8.9% following implementation (p=1.00). Of these canceled appointments, 19.4%, 77.4%, and 3.2% of patients had 3, 1 or 2, or no comorbidities that increased the risk of severe COVID-19 infection, respectively. Forty-two surveys were completed: 95.2% of respondents were satisfied with our curbside INR service, 2.4% had neutral satisfaction, and 2.4% were dissatisfied. Overall, respondents felt that curbside INR visits were shorter than in-clinic INR visits. Conclusions: Curbside INR visits maintained attendance at the pharmacist-led INR monitoring
service despite the COVID-19 pandemic. The majority of patients were satisfied with our service and 88.1% of respondents indicated that they would like curbside INR visits to continue after COVID-19 social distancing requirements become less strict. ••••••••••••••••••••••••••••••••
Title: A Psychiatric Presentation of Antiepileptic-Induced Aseptic Meningitis Authors: P. Brittany Vickery, PharmD, BCPS, BCPP, CPP; J. Kyle Roach, Doctor of Pharmacy Candidate 2023; Stephen Vickery, PharmD, BCPS Institution: Wingate University School of Pharmacy, Wingate NC
Introduction: Aseptic meningitis is described as meningeal inflammation not occurring from a bacterial cause. While uncommon, this condition may arise from antiepileptic use (antiepileptic-induced meningitis or AEIM). Only three drugs in this class have documented cases: lamotrigine, carbamazepine, and levetiracetam. This report highlights one of only two suspected cases of AEIM with levetiracetam use. Case: A 54-year-old gentleman presented with hypersomnolence and altered mental status, specifically confusion. The patient was previously given levetiracetam at a different facility after presenting with possible seizure and he had not received recent antibiotics. On day one, the patient had no nausea/vomiting, headache, fever, neck pain, and rash. Brain MRI scan was negative and serology tests (ANA and dsDNA) showed no detection. On day two, levetiracetam therapy was stopped and replaced with lacosamide, and a lumbar puncture was performed for CSF analysis which revealed Page 15
lymphocytic pleocytosis, high protein, and slightly high glucose, notably. Acyclovir 1000 mg intravenous was also initiated. By day three, CSF cultures were negative, and the patient’s symptoms had drastically improved after stopping levetiracetam. The patient was discharged on day four with orders to continue acyclovir orally for seven additional days. Discussion: Aside from altered mental status, the patient did not present with any other symptoms of AEIM. CSF analysis was performed to exclude other causes. Results of the analysis strongly correlated with a drug-induced cause, but they also mimicked a viral cause, leading to empiric acyclovir therapy. CSF lymphocytic pleocytosis (commonly seen in viral meningitis) led to suspicion of a possible viral cause, despite the correlation to AEIM. Improvement of symptoms two days after stopping levetiracetam was a very important sign for suspected AEIM. All other reports of meningitis from antiepileptic use highlighted symptom resolution a few days after discontinuing the offending agents. Clinicians who prescribe antiepileptics should always consider AEIM. ••••••••••••••••••••••••••••••••
Title: Lipase Elevation and Subsequent Resolution with Continued Injectable Semaglutide: A Case Report Authors: 1Ryan Kendall; 2,3Cortney Mospan, PharmD, BCACP, BCGP; Patrick Fillnow, MD3 1University of Georgia, Athens, GA 2Wingate University School of Pharmacy, Wingate, NC 3Novant Health Internal Medicine Providence, Charlotte, NC
Introduction: Lipase and amylase levels have been found dose-in-
dependent, reversible events that have little predictive value for risk of acute pancreatitis. Lipase elevations have been found to occur in approximately 33% of patients taking liraglutide, yet only 0.3% of patients developed acute pancreatitis. No data is available regarding the clinical significance of lipase elevation with injectable semaglutide.
Case: A 79 year-old male with type 2 diabetes, hypertension, hyperlipidemia, macular edema, and merkel cell carcinoma was started on injectable semaglutide 0.25 mg once weekly. Other diabetes medications at treatment initiation included metformin ER 1000 mg twice daily and glipizide 10 mg twice daily. One week after injectable semaglutide was initiated, elevated lipase (259 U/L) and normal amylase (46 U/L) levels were identified as part of routine monitoring related previous chemotherapy for treatment of merkel cell carcinoma. A CT scan showed no evidence of acute pancreatitis and the patient endorsed no symptoms of acute pancreatitis. Since the patient was asymptomatic, injectable semaglutide was continued. Three weeks later, lipase (47 U/L) and amylase (29 U/L) were within normal limits. The patient was able to be successfully titrated to semaglutide 1 mg once weekly without developing acute pancreatitis.
Discussion: The findings of this case report are consistent with available literature with liraglutide showing that lipase elevation is a poor predictor of risk of acute pancreatitis and glucagon-like 1 peptide receptor (GLP-1) agonists can be continued without significant risk if lipase and/or amylase elevations are identified. This case demonstrates resolution of lipase elevations without treatment discontinuation of injectable
semaglutide. Routine lipase and amylase level monitoring should not be utilized in GLP-1 therapy monitoring due to poor predictive risk of acute pancreatitis and potential to cause unwarranted short-term or permanent cessation of the medication.
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Title: Successful Concomitant Use of Oral Semaglutide with Levothyroxine to Achieve Glycemic Control: A Case Report Authors: Alexis Jones1, PharmD Candidate; Cortney Mospan1,2, PharmD, BCACP, BCGP; Patrick Fillnow2, MD 1Wingate University School of Pharmacy, Wingate, NC 2Novant Health Internal Medicine Providence, Charlotte, NC Introduction: In September 2019, the US Food and Drug Administration approved the first oral glucagon-like peptide 1 receptor agonist. Use of oral semaglutide in patients taking levothyroxine presents a challenge as both medications are advised to be taken first thing in the morning, on an empty stomach. This is the first case study to describe concomitant use of oral semaglutide and levothyroxine and the impact on diabetes mellitus and hypothyroidism outcomes.
Case: A 52 year-old female with diabetes and hypothyroidism was started on oral semaglutide 3 mg daily and ultimately titrated to 14 mg daily. Other concomitant therapies included empagliflozin 25 mg daily, metformin ER 1000 mg twice daily, pioglitazone 45 mg daily, and levothyroxine 25 mcg daily. A1c at treatment initiation was 11.9%, which decreased to 5.4%. TSH level at oral semaglutide initiation was 2.23 uIU/mL and 2.37 uIU/mL after approxiPage 16
mately six months of therapy. No changes in hypothyroidism symptoms were noted.
Discussion: There are no case reports describing concomitant use of oral semaglutide with levothyroxine; however, clinical drug interactions studies have shown levothyroxine exposure to be increased by 33% when co-administered with oral semaglutide. In our patient, TSH level showed a slight decrease, suggesting increased levothyroxine exposure. However, this was not clinically significant and the patient’s TSH stayed within range with no changes in related symptoms. Following the stated package insert guidance of taking oral semaglutide 30 minutes before any food, drink, or medication administration resulted in significant A1c lowering. As a result, initiating oral semaglutide concomitantly with levothyroxine had no clinically significant impact on TSH level or hypothyroidism symptoms. The patient was able to successfully meet
••••••••••••••••••••••••••••••••• Title: Examination of Pharmacists’ Support for Implementation of Syringe Exchange Programs in Community Pharmacies in North Carolina: A Social Ecological Approach Authors: Heather H. Roberts, PhD, RN, MSN; Debra C. Wallace, PhD, RN, FAAN; Anna Stein, JD, MPH; Amanda Isac, PharmD, MPH; Acknowledgements: Ratchneewan Ross, PhD, RN, FAAN; Robin Bartlett, PhD, RN; Mark Schulz, PhD Institution: University of North Carolina at Greensboro
Objective: This study examined NC community pharmacists’ sup-
port of implementation of syringe exchange programs in community pharmacies and factors associated with support. Methods: This cross-sectional study was guided by the Social Ecological Model. NC community pharmacists (N = 304) were surveyed using an online survey. Frequencies, proportions, Somers’ d, PLUM ordinal regression, and Chi-squared analyses were used to answer 6 research questions.
Results: More than two thirds of NC community pharmacists support implementation of a syringe exchange program in their pharmacy to some extent. Factors most strongly associated with support were beliefs about syringe exchange programs, receiving education on syringe exchange programs, type of community pharmacy, concern about having increased numbers of injection drug users in the pharmacy, and receiving training on how to implement a syringe exchange program. Factors predicting support were type of community pharmacy (independent/chain), gender, and years of practice. Support and factors differed between chain and independent community pharmacists. Chain community pharmacists were 56.1% less likely to express support to a greater extent compared to independent community pharmacists. Chain community pharmacists had fewer beliefs about the effectiveness of syringe exchange programs and more concerns associated with implementation. Male community pharmacists were more likely to support implementation to a greater extent as were community pharmacists with 11 to 20 years of practice. Conclusions: NC community pharmacists support pharmacy-based syringe exchange pro-
grams to some extent. Concerns and some lack of knowledge of the overall potential public health impact of syringe exchange programs existed and stigmatization of injection drug users was suggested. Strategies to mitigate concerns and increase knowledge about syringe exchange programs and implementation processes and to reduce stigma are warranted. Community pharmacists and public health nurses provide an excellent collaborative engagement to develop and implement these strategies.
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Title: The Impact of COVID-19 on Social Media use Among Pharmacy Student Organizations Authors: Kiarra Bowser, PharmD Candidate, Susan M. Smith, BS, PharmD, BCPS Institution: Wingate University School of Pharmacy, Wingate, NC
Objectives: Throughout the COVID-19 pandemic, pharmacy students changed how they learn and communicate. The primary objective of this study was to determine whether students found pharmacy student organization social media content beneficial. The secondary objective was to determine what organizations had the greatest student following and assess whether social distancing barriers impacted the number of social media postings. Methods: Facebook and Instagram posts in Fall semesters 2020 and 2019 by 13 student pharmacy organizations were retrospectively reviewed (March 2021) to determine the overall number of posts. Additionally, a survey was distributed to 146 second- and third-year pharmacy students (80 and 66, respectively) to determine Page 17
their perceptions of social media postings made by organizations. Perception data captured included frequency of checking posts, usefulness of posts, and student use in 2020 compared to 2019.
Results: Nine (69%) student organizations made 597 posts on social media (Fall 2020 [n=403, 68%] and Fall 2019 [n=194, 32%]). SNPhA posted the most in 2020 (n=295, 73%) and 2019 (n=63, 32%). Survey response rate was 47% (n=68). Most of the survey respondents belonged to APhA-ASP (n=32, 47%), NCAP (19, 28%), and SNPhA (n=19, 28%). All students who belonged to SNPhA (n=19) and KE (n=13) followed their organizations’ social media sites. Students followed their organizations on a weekly basis (n=43, 43%) and found the posted information to be extremely useful (n=39, 39%) or somewhat useful (n=48, 48%). Students utilized social media about the same in 2020 compared to 2019 (n=46, 46%). Forty (40%) students stated they used social media more in 2020 compared to 14 (14%) in 2019. Conclusions: Overall, social media posting was higher in 2020. Additionally, students appeared to rely more on social media to receive information about their organizations during the fall semester of the pandemic compared to the previous year.
••••••••••••••••••••••••••••••••• Title: Impact of outpatient transitions of care pharmacy program on interventions for discharged patients in a community hospital Authors: Tiffany Kahl, PharmD1,2, Amanda Wright, PharmD1, Deanna Benz, PharmD, BCOP1, Elizabeth Hudson, PharmD, MBA1, Heather McLeod,
PharmD, BCACP1, Taylor Wells, PharmD, MBA1, Emily Ghassemi, PharmD, BCACP, CDE, CPP2 Institution: Cape Fear Valley Medical Center, Fayetteville NC; Campbell University College of Pharmacy & Health Sciences2, Buies Creek NC
Objective: In August 2020, Cape Fear Valley Medical Center (CFVMC) implemented a transitions of care (TOC) pharmacist position in order to facilitate successful patient transitions from inpatient to outpatient care. The purpose of this project was to describe the clinical impact of the discharge process and the potential need for additional TOC pharmacists in this role.
Methods: This was a single-centered retrospective chart review including patients discharged from CFVMC through the discharge lounge between 09/01/2020 and 12/1/2020. The primary objective was describing intervention types made by the TOC pharmacy staff on discharge prescriptions. Secondary objectives were to determine the number of patients requiring interventions, acceptance rate of interventions requiring provider approval, and time spent on interventions. Results: There were 6,185 patients discharged through the discharge lounge between 09/01/2020 and 12/1/2020. 563 discharge medication interventions were completed by the TOC pharmacy staff on 440 unique patients. The most frequent intervention types were preventing medication error (38.1%), addressing socioeconomic barriers (21.8%), and providing medication optimization (19.3%). It took pharmacy staff less than 10 minutes to complete 77.7% of
interventions and more than 10 minutes to complete the remaining 22.3%. Eighty-six percent of interventions requiring provider approval were accepted.
Conclusions: The implementation of a TOC process has resulted in various types of interventions, which help to facilitate patient transition from inpatient to outpatient care. Future studies could be designed to assess patient outcomes associated with the implementation of TOC pharmacist(s). ••••••••••••••••••••••••••••••••• Title: Anaphylaxis Case Report to Oral Semaglutide and Extended Release Exenatide Authors: Alicia Guthrie, PharmD, MBA; Lindsay Sheehan, PharmD, CDCES, CPP Institution: Atrium Health, Concord, NC
Introduction: Glucagon-like peptide 1 receptor agonists (GLP-1 RA) are a mainstay of therapy for patients with type 2 diabetes mellitus (T2DM). Common adverse reactions of GLP-1 RAs are gastrointestinal (GI) side effects such as diarrhea, constipation, nausea, and abdominal pain; however, anaphylaxis is listed as a possible adverse reaction. This report details two patients who experienced anaphylaxis while taking oral semaglutide and extended release exenatide, respectively.
Case(s): The first patient is a 56-year-old male who was initiated on oral semaglutide for T2DM and weight loss. It was known that he had previously taken liraglutide and dulaglutide but had not tolerated due to GI upset. The patient was interested in retrying another GLP-1 RA so oral semaglutide 3mg once daily was initiatPage 18
ed. After 30 days, his dose was increased to 7mg daily. Almost two weeks after he increased to 7mg, he experienced “sour stomach”, diarrhea, itching of the hands, and eventually swelling of his throat. He became unresponsive and was transported to the emergency department where he was treated for anaphylaxis with epinephrine and steroids. The second patient is a 53-yearold female who was initiated on extended release exenatide for T2DM and weight loss. She had previously taken liraglutide, but did not report any adverse effects from it. A few hours after her second dose of exenatide she started to experience shortness of breath, leg and lip swelling, headache, and urticaria. She was taken to the emergency department where she was treated with fluids, antihistamines, and steroids.
Discussion: These cases highlight that anaphylactic reactions can present in several ways. While GI upset is a common side effect of GLP-1 RAs, it can also be a symptom of anaphylaxis in some patients. It is important to recognize potential signs of allergic reactions, especially those that are less common or obvious. •••••••••••••••••••••••••••••••••
Title: Evaluation of Pharmacist Integration into Migraine Management within Primary Care Practices
Authors: Rachel Trimmer, PharmD, Dawn Caviness, MD, BSN, CDE, Paige Carson, PharmD, CDCES, BCPS, CPP, Lydia Wang, PharmD, BCPS, BCACP, DPLA, CPP, Lindsay Sheehan, PharmD, CDE, CPP, Kayla Morgan, PharmD, BCACP, CDCES, CPP, Lauren Downing, PharmD Institution: Cabarrus Family
Medicine – Concord; Kannapolis Internal Medicine
Objective: The primary purpose of this study is to evaluate the impact of pharmacist integration into migraine management within Atrium Health primary care practices.
Methods: The medical records of 61 patients with clinically diagnosed migraine from December 2020 to early April 2021 were reviewed. Patients under the age of 18 and/or patients currently being managed by a neurologist or headache specialist were excluded. A pharmacy resident chart reviewed each patient, conducted an initial migraine assessment, and proposed recommendations for medication therapy optimization to individual primary care providers. Accepted therapy recommendations were implemented by the pharmacist, and follow-up assessments were completed monthly by the pharmacist to assess for tolerability and efficacy of the medications. Data collected included patient demographics, current and previously failed migraine therapies, baseline and follow-up migraine frequencies, provider referrals, and acceptance/denial of pharmacotherapy recommendations.
migraine therapy management interventions.
Conclusion: Despite being an extremely prevalent and disabling neurologic disorder, migraine tends be either overlooked and/or undertreated. The utilization of a pharmacist in a setting that allows for observation and monitoring of migraine management can lead to improved migraine outcomes and overall quality of life. ••••••••••••••••••••••••••••••••• Title: Evaluation of Antibiotic Use in Patients with Gram Positive Bacteremia After Implementation of a Rapid Diagnostic Blood Culture Panel with Pharmacist Review Authors: Thomas Sessoms, PharmD, Toni Pate, PharmD, Thomas Brown, PA-C, Serina Tart, PharmD Institution: Cape Fear Valley Medical Center
Objective: The primary purpose of this study was to evaluate the impact on the time to targeted therapy in patients with gram positive bacteremia after implementation of a rapid diagnostic blood culture panel (Biofire Blood Culture Identification Panel BCID2TM) with pharmacist Results: Sixty-one patients under- review compared to traditional testing. Secondary objectives were went the initial migraine assessment. Pharmacist identified thirty to compare: mean time to organof these patients as candidates for ism identification; hospital wide medication therapy optimization. days of therapy/1000 patient days Medication adjustments included (DOT) for vancomycin, daptomycin, and linezolid; and length of addition, titration, or change in stay. current acute and prophylactic migraine treatments based on Methods: This retrospective, current guidelines for migraine quality improvement cohort study management. While not finalincluded patients admitted at a ized, results indicate reduction large community hospital from in migraine frequency, improved December 1, 2020 to February 28, utilization of guideline directed therapies, and improved access to 2021 with gram positive bacteremia identified by the BCID2. medications with pharmacist-led Page 19
BCID2 testing started November 3rd, 2020 and a select group of pharmacists were educated/provided with a standardized algorithm for antibiotic recommendations. Comparison of endpoints were made to a control group of patients with gram positive bacteremia admitted July 1, 2020 to September 30, 2020 prior to BCID2 implementation. Data was collected on patient pre-existing conditions.
Results: The control group had 101 patients that met inclusion criteria, with a mean of 89.1 hours to targeted therapy; mean length of stay 3.7 days and mean time to bacteria identification 88.5 hours. The mean DOT for intravenous vancomycin in July-September compared to December-February was 65.7 to 60.9, for daptomycin 7.83 to 6.69, and for linezolid 16.4 to 16.4. There were 161 patients identified that met inclusion criteria in the post-intervention group, with data collection in progress and statistical analysis pending. Conclusion: In progress
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Title: Impact of pharmacist-provided telehealth management of diabetes on HbA1c pre-COVID-19 and during the COVID-19 pandemic
Authors: Lindsy Coan, Pharm.D., BCACP, CDE [Principal Investigator]; Angela Porter, Pharm.D., BCACP, CDE [Co-Principal Investigator]; Shekinah Baum, Pharm.D. [PGY1 Resident, Study Coordinator] Institution: Charles George VA Medical Center (Western North Carolina VA Healthcare System) Objective: The primary objective of this evaluation was to assess the change in HbA1c in patients
with types 1 and 2 diabetes mellitus before and during the rapid implementation of telehealth clinic visits as a result of the COVID-19 pandemic. Secondary objectives were to identify confounding impacts of the the widespread metformin SA drug recalls during the same time frame and to examine if travel distance to the VA clinic impacted results.
Methods: A retrospective chart review included subjects participating in face-to-face diabetes-focused visits with a pharmacist provider prior to the COVID-19 pandemic [June 1, 2019 to December 1, 2019] who were subsequently transitioned to telehealth diabetes management via VA Video Connect (VVC) or telephone clinic visits during the COVID-19 pandemic [June 1, 2020 to December 1, 2020]. One or more HbA1c readings within each specified timeframe was required for inclusion. Patients were excluded if they were previously enrolled in a VA telehealth diabetes management program. Results: Five hundred and twenty-two patients met study criteria. Preliminary results showed 72% of subjects-maintained diabetes control when transitioned to telehealth management during the COVID-19 pandemic. Maintenance of diabetes control was defined as change in HbA1c +/- ≤ 1.0% which considered laboratory margin of error and clinically insignificant changes of HbA1c. An additional 12.2% of subjects had HbA1c decrease of > 1%, while 15.7% experienced an >1% increase in HbA1c. A total of 57 patients were subsequently taken off metformin SA secondary to drug recall during the COVID-19 pandemic. Prior to the implementation of telehealth visits, over 52% of patients were traveling greater than 50 miles round-trip
to receive face-to-face diabetes care.
Conclusion: The rapidly implemented telehealth management of diabetes mellitus provided by pharmacist providers resulted in effectively managed diabetes control in 84.2% of patients included in this analysis.
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Title: COVID-19 Vaccination: Virtual Education Outreach Among a College Campus Community Authors: Lacy La Fever, BS, MS, Joe Norton, BS, Savannah Poole, Kendra Rice, Alexis Underwood, Amie J. Dirks-Naylor, MS, PhD Institution: Wingate University School of Pharmacy, Wingate, North Carolina. Objectives: The majority of new COVID-19 cases are in young adults ages 18-29 years. Vaccines have now been developed, however, a significant portion of the population are reluctant to become vaccinated. Research shows that education can increase trust in vaccines and increase vaccination rates. Thus, the objective of the study was to determine the impact of a pharmacy student virtual service learning project on COVID-19 vaccine knowledge and vaccine willingness among a college campus community. Methods: A synchronous virtual Zoom presentation provided information about COVID-19 and available vaccines. Study participants were students and staff of a college campus community recruited via university-wide advertisements and social media platforms. Pre-tests and posttests, composed of true or false based questions, were utilized to assess participant knowledge before and after the educational presentation. Participant engagePage 20
ment involved answering and asking questions via the Zoom chat feature or unmuting their microphones.
Results: 131 and 100 subjects completed the pre- and post-surveys, respectively. Results confirmed that the educational session improved knowledge regarding the vaccines and likelihood of vaccination. There was a 17% increase in correct myth vs. fact questions and a 24% increase in correct knowledge-based questions. There was a 8% increase in those willing to get vaccinated as soon as eligible. There was a 16% increase in the number of those who agreed that they would encourage others to get vaccinated with only 6% who disagreed in doing so. Participants were interactive throughout the presentation and interested in learning more about the myths and safety of the specific vaccines presented.
Conclusion: Overall, participants showed an increase in knowledge concerning COVID-19 vaccines after participating in the virtual education session. There was also an increase in the number of participants willing to get vaccinated and those willing to encourage others to get vaccinated.
••••••••••••••••••••••••••••••••• Title: Evaluation of a Pharmacist-Led Naloxone Education Program
Authors: Alexis Robinson, PharmD, Lydia Wang, PharmD, BCPS, BCACP, DPLA, CPP, Denine Hill, PharmD, Paige Carson, PharmD, CDE, BCPS, CPP, Kamaria Brown, PharmD, BCPS, BCACP, DPLA Institution: Atrium Health: Biddle Point Pharmacy, Myers Park Pharmacy; Charlotte NC
Objective: The purpose of this study is to evaluate the effect of a pharmacist-led naloxone education program on amount of naloxone dispensed according to CDC recommendations within a 340B pharmacy. The primary endpoint is the difference in amount of Narcan dispensed after naloxone training and education for pharmacists at Biddle Point clinic pharmacy compared to Myers Park clinic pharmacy without naloxone education and training. Secondary endpoints include cost of Narcan training, Narcan co-pay, and pharmacist, provider, and patient satisfaction.
Methods: Medical records of patients with active opioid prescriptions between September 1, 2020 and December 20, 2020 were identified and accessed through Canopy-Powerchart and QS1 for Biddle Point and Myers Park pharmacies. Those who filled opioids at outside pharmacies were excluded. Data collected included patient demographics, treatment regimens, risk factors for opioid overdose, Narcan dispensed, Narcan cost, Narcan use, and patient, provider, and pharmacist satisfaction. Results: A total of 95 patients (32 at Biddle Point; 63 at Myers Park) were included with a mean age of 55 years. Most common opioids included oxycodone, hydrocodone, and morphine. Average MME was 48 at Biddle Point and 87 at Myers Park. Fifteen patients (47%) at Biddle Point received Narcan via pharmacist intervention versus 23 patients (37%) at Myers Park without pharmacist intervention (p=0.33). Narcan training was free via the Narcan website. For Biddle Point patients who received Narcan, average copay was $6.40. Zero Biddle Point patients required Narcan admin-
istration for opioid overdose. Patients and physicians were satisfied with the education provided by pharmacists. Pharmacists were satisfied with the program and felt it would be useful to implement at other clinics. Conclusion: Pharmacist-led naloxone education programs can increase access to Narcan in case of life-threatening opioid overdose without significant cost to the patient.
••••••••••••••••••••••••••••••••• Title: Implementation of PROMIS Global-10 Quality-of-Life Survey in Specialty Pharmacy Authors: Yujing Steenwyk, PharmD; Nick Gazda, PharmD, MS, BCPS, CSP Institution: Cone Health, Greensboro, NC
Objective: The primary objective of this study was to assess the mean PROMIS Global-10 quality-of-life scores for Cone Health Rheumatology (CHR) patients who filled an interleukin-17 (IL17) inhibitor at a specialty pharmacy. The secondary outcome was to compare the scores of patients who filled at Cone Health Specialty Pharmacy (CHSP) versus those who filled at other specialty pharmacies. Methods: Patients were included if they were at least 18 years old, were current patients at CHR, and had been on one of two IL-17 inhibitors, secukinumab or ixekizumab, for at least three months as of November 2020. PROMIS Global-10 surveys were conducted over the phone in December 2020. Patients were excluded if they could not be reached after three attempts. Prescription claims data were used to collect baseline information on patients who did not fill at CHSP. DescripPage 21
tive statistics and Student’s t test were used for the primary and secondary outcomes, respectively. Results: Forty-one patients met the inclusion criteria, and 37 patients completed the PROMIS Global-10 survey. Of these, 27% filled at CHSP, while others filled at 11 outside specialty pharmacies. For the primary outcome, the mean mental score was 49.6 or very good, the mean physical score was 44.8 or good, and the mean pain score was 3.8 out of 10. For the secondary outcome, there was no significant difference in the mental score (48.1 vs 50.2; 95% CI, -7.27–3.10), physical score (46.9 vs 44.1; 95% CI, - 2.40–8.02), or pain score (3.7 vs 3.85; 95% CI, -1.8–1.49) between patients who fill at CHSP versus other specialty pharmacies.
Conclusion: On average, CHR patients on IL-17 inhibitors reported good to very good quality of life using the PROMIS Global-10 survey. There was no difference in the PROMIS Global-10 scores between patients who fill at CHSP versus other specialty pharmacies.
••••••••••••••••••••••••••••••••• Title: Outpatient pharmacists’ role in pre-exposure prophylaxis: A survey of North Carolina pharmacists Authors: Austyn Posey, PharmD1,2; Amy Lenell, PharmD2; Maxwell Bible, RPh2; Laura A. Rhodes, PharmD, BCACP1,3; Macary Weck Marciniak, PharmD, BCACP, BCPS, FAPhA1
Institution: 1University of North Carolina at Chapel Hill, Chapel Hill, NC; 2Walgreens, Asheville, NC; 3Palm Beach Atlantic University, West Palm Beach, FL
Objectives: Evaluate outpatient pharmacists’ (1) attitudes and interest toward prescribing pre-exposure prophylaxis (PrEP) in North Carolina and (2) knowledge of PrEP therapy and monitoring parameters. Methods: This cross-sectional study was conducted through an internet-based questionnaire platform, Qualtrics. Using the North Carolina Board of Pharmacy’s database, a link to a questionnaire was emailed to all actively licensed pharmacists. Responses were included from outpatient pharmacists. Pharmacists with invalid email addresses, respondents not practicing in an outpatient setting, or incomplete survey responses were excluded. The 33-item questionnaire assessed pharmacists’ willingness to dispense PrEP, knowledge of PrEP and monitoring parameters, perceived barriers to prescribing PrEP, preferred method of receiving educational training, and demographic information. The survey was open for 30 days with a reminder sent on day 15. A gift card incentive was offered for survey completion. Descriptive statistics was used to analyze survey responses. Results: In total, 370 survey responses were received (2.1% response rate, 370/17,994). Respondents were 65.7% female (n=243) and 7.8% identify as Human Immunodeficiency Virus (HIV) specialists (n=29). Of those responding, 90% agreed or strongly agreed that PrEP can be a beneficial HIV prevention approach in some vulnerable populations. Additionally, 77% disagreed or strongly disagreed that widespread use of PrEP would contribute to increased rates of HIV transmission. Also, 77% reported interest in prescribing PrEP. Knowledge of PrEP therapy
and monitoring parameters was identified as an area of improvement as 62% did not correctly identify which medication can be used in males for PrEP therapy and 38% did not correctly indicate how often patients taking PrEP should be tested for HIV. Conclusion: Positive attitudes toward prescribing PrEP were demonstrated by North Carolina pharmacists practicing in an outpatient setting. Future directions include enhancing continuing education regarding PrEP therapy and utilizing data collected to support legislation for pharmacist-prescribed PrEP therapy.
••••••••••••••••••••••••••••••••• Title: Impact of Pharmacy Benefit Managers on North Carolina Pharmacies and Patients Authors: M. Ryan Brownlow, Rebecca Lee, Beth Mills, PharmD, BCACP, CDCES, CPP Institution: Campbell University College of Pharmacy & Health Sciences
Objective: There is anecdotal evidence of the negative impact pharmacy benefit managers (PBMs) can have on independent pharmacies, patients, and the healthcare system as a whole. However, there is insufficient data highlighting unfair practices by PBMs, specifically in North Carolina. The purpose of the study was to gather data and specific examples of PBM practices to demonstrate if there is evidence of PBM unfair practices, and to determine the impact it may have on independent pharmacies and their patients in North Carolina. Methods: An anonymous survey was distributed to North Carolina independent pharmacy managers Page 22
and owners via email and social media, utilizing Qualtrics Online Survey Platform from November 18, 2020 to April 12, 2021. Results from 55 responses were de-identified and used to supplement advocacy efforts by the North Carolina Association of Pharmacists. Results: Surveyed pharmacy managers and owners working in NC reported specific examples of unfair practices by PBMs they have encountered, including: direct and indirect remuneration (DIR) fees, decreased reimbursement, forced mail order, preferred networks, and patient steering. In addition, 87.1% of respondents reported being forced to turn away a patient or their prescription due to the high net loss to the pharmacy if the prescription was filled. Alarmingly, 67% of pharmacies had to turn away patients more than five times a month, and 41% had to turn away patients more than 10 times a month. Respondents reported planned retirement as a result of financial hardships from PBM abuse affecting their pharmacy. Additionally, pharmacists submitted 67 examples pertaining to specific PBM abuse in day-to-day experiences in their pharmacies. Comments ranging from “unethical and dangerous practices” to “predatory audit practices” display emotional responses from North Carolina pharmacists. 100% of participants stated that they would support a bill to reform PBM practices in North Carolina.
Conclusion: Evidence suggests pharmacies and patients in NC are negatively impacted by ethically-questionable PBM practices in North Carolina.
Residency Conference Wrap-Up This is always an exciting time of year for residency programs and NCAP loves being part of it by hosting the annual Residency Conference. Although the event was virtual, we still had a total of 228 registrants representing 30 programs from across the state tune in this year. The planning committee, chaired by Dr. Mary Parker, created a program filled with content designed to enrich and inspire residents, preceptors and program directors alike.
Thank you to our planning committee for creating the programming this year and to our speakers who shared their time and expertise to present topics addressing practicing pharmacy in North Carolina; social determinants of health; research topics and academic writing; and the importance of your state association (NCAP) including how you can be involved in effecting positive change for pharmacy in North Carolina.
We can’t wait to see everyone in residency in person next year. Our 2022 Residency Conference is scheduled for Friday, July 8 at the Novant Conference Center in Winston-Salem, NC! We look forward to seeing you there. Until then, have a most successful year.
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NCAP Executive Fellow Position
Hello!
My name is Megan Yelenic Witkowski and I am the new NCAP Executive Fellow. I was born in Pittsburgh, Pennsylvania, but I have lived in North Carolina for the past 15 years. I previously attended UNC Chapel Hill for my undergraduate studies and
majored in biology. Go Heels! I recently graduated from Campbell University with my PharmD and MSPH. Throughout my training at Campbell, I came to realize my passion for promoting health and wellness at the population level to help our communities become happier and healthier. Additionally, the loss of my mother to breast cancer at a very young age and my own diagnosis with a BRCA1 mutation, has led me to become a strong advocate for women and their health. I was drawn to the NCAP Executive Fellow position as a way to connect my public health training and my passion for advocacy with the advancement of pharmacy as a profession. I am most looking forward to helping NCAP establish new services, programming, and resources to assist pharmacists in enhancing their practice.
Throughout this next year, I welcome the opportunity to be more involved in our legislative work, stakeholder engagement, and leadership development. Most importantly, I am excited to network with pharmacists across the state. I am newly married to my husband, David, who is a NC public school teacher. Together, we adopted a sweet and sassy diluted calico named Coco. I love all things Pittsburgh and I am a huge Steelers and Penguins fan. My new COVID hobby is reading, after I joined a virtual wine and book club with some close friends during lock-downs. In my free time, I love trying out new recipes in the kitchen, exploring local spots in Raleigh, and spending time with my friends and family whether it is at the beach or just at home.
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Avoid Federal Law Violations on Newly Expanded Access Buprenorphine Prescriptions By: Dr. Trenton Thiede Prescriptions for buprenorphine containing medications continue to be an audit target by PBMs. Due to the nature of this medication, patients are filling these prescriptions frequently and it can be an easy trap for a pharmacy to miss state and federal requirements. Unfortunately, this can lead to law violations resulting in full recoupment of the claim.
Pharmacies must ensure that all state and federal requirements for controlled substances are included on any buprenorphine prescription, as well as the prescriber’s XDEA number, if prescribed for opioid dependency. This additional requirement was set forth in the Drug Addiction Treatment Act of 2000 (DATA 2000). (1) PAAS National® continues to see audit recoupments where pharmacies are missing both DEA and XDEA numbers on buprenorphine prescriptions. Due to the discrepancy being a federal law violation, these are difficult to appeal.
There has been a few recent events that have created confusion surrounding prescriber requirements that PAAS wants to touch on in the event that you get questions from patients or prescribers. In January 2021, HHS announced that it was planning to eliminate the requirement for prescribers to obtain an XDEA number to prescribe buprenorphine, however this action was withdrawn with the incoming Biden Administration. (2) Additionally, On April 28, 2021, HHS issued a notice, effective immediately, that it will allow eligible prescribers to obtain an XDEA number without having to complete the mandatory 8-24 hours of training. (3) These prescribers will be limited to treating no more than 30 patients and are still required to obtain an XDEA number and include on subsequent prescriptions. PAAS Tips:
• Educate all staff on controlled substance requirements: patient address, prescriber address, prescriber DEA number should all be on the front of the prescription. • Any buprenorphine containing prescription for treatment of opioid dependency, requires BOTH DEA and XDEA numbers on the prescription. • Buprenorphine prescribed for pain should be clearly indicated on the prescription and only the DEA number is required. • Dosage forms should be specified, tablets or films. • Tablets and films are not indicated to be cut, chewed or swallowed per manufacturer. • Patient labels should instruct to use “sublingually,” “under the tongue,” or “in the cheek.” • Recommend running weekly reports to check hard copies for all requirements.
PAAS National® is committed to serving community pharmacies and helping keep hard-earned money where it belongs. Contact us today at (608) 873-1342 or info@paasnational.com to see why membership might be right for you. By Trenton Thiede, PharmD, MBA, President at PAAS National®, expert third party audit assistance and FWA/HIPAA compliance. ©2021 PAAS National® LLC All Rights Reserved References:
1. https://www.congress.gov/106/plaws/publ310/
PLAW-106publ310.pdf
2. https://www.hhs.gov/about/news/2021/01/14/
hhs-expands-access-to-treatment-for-opioid-usedisorder.html 3. https://www.federalregister.gov/documents/2021/04/28/2021-08961/practice-guidelines-for-the-administration-of-buprenorphine-for-treating-opioid-use-disorder
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as a whole tablet or crushed and mixed in water.
New Drug Monograph
Distribution - Protein binding at 98% with a volume of distribution of 44L.
VerquvoTM (vericiguat)
Metabolism - Glucuronidation occurs by UGT1A9. Less than 5% of metabolism is done by CYP enzymes.
Elimination - Patients with HF – t1/2 = 30 hours; Healthy patients – 1.6L/hr clearance; Inactive metabolites excreted in the urine = 53%; Unchanged drug excreted in the feces = 45%
By: Dr. Melissa Dempsey Background: Approved January 20, 2021
Classification: Soluble guanylate cyclase stimulator
Indication: FDA Approved – Heart failure with reduced ejection fraction (HFrEF) – specifically in patients with high risk of heart failure (HF) exacerbation who have recently been hospitalized or have needed intravenous (IV) diuretics. Contraindications: Use of other soluble guanylate cyclase stimulators. Pregnancy – Category X due to embryo-fetal toxicity.
US Boxed Warning: Vericiguat is associated with embryo-fetal toxicity. Women of childbearing age should take a pregnancy test and be counseled on contraception before initiating this medication. A pregnancy test one month after discontinuation is also recommended.
Pharmacology: Variciguat works by stimulating soluble guanylate cyclase (sGC), which in turn helps to sensitize the patient to endogenous nitric oxide. Patients with HF have endothelial dysfunction, which in combination with oxidative stress and inflammation results in sGC insufficiency, leading to myocardial and vascular dysfunction. Variciguat fixes this process at the sGC step, resulting in cardioprotection. Pharmacokinetics:
Absorption - Bioavailability is 93% when administered with a high-fat, high-calorie meal. It can be taken orally
Clinical Efficacy: In the SOCRATES-PRESERVED and SOCRATES-REDUCED phase-2 trials, two patient populations were evaluated on the safety and optimal dosing of vericiguat. SOCRATES-PRESERVED recruited 477 patients with HF with a preserved ejection fraction (HFpEF) and divided them into 5 arms: vericiguat 1.25mg, 2.5mg, 2.5mg titrated to 5mg, 2.5mg titrated to 10mg, and placebo. Endpoint analysis was done at baseline and week 12 on left arterial volume (LAV) and N-terminal pro-B-type natriuretic peptide (NT-proBNP). Data across the 2.5mg – 10mg treatment arms was pooled for primary analysis, revealing a non-statistically significant mean baseline decrease in LAV of -1.732mL compared to -3.361mL for placebo (p = 0.8156). Similar results were shown with log(NT-proBNP) data and a mean change of 0.038 for the treatment pooled arms compared to -0.098 for placebo (p = 0.8991). The Kansas City cardiomyopathy questionnaire (KCCQ) score that evaluated patient quality of life as a secondary endpoint improved 9.2 points after 12 weeks (p = 0.016) with vericiguant 10mg. In patients with HFrEF, SOCRATES-REDUCED recruited 456 patients and divided them into the same 5 treatment arms. After a follow up of 12 weeks, log(NT-proBNP) was evaluated as the primary endpoint. This study found similar results with no statistically significant difference of means for log(NT-proBNP) between pooled treatment arms and placebo (-0.122, p = 0.15). Higher doses of vericiguat displayed a greater reduction in NT-proBNP than lower doses: 10mg mean difference of -0.250, 2.5mg mean difference of -0.040, p < 0.02. Though not powered to detect a difference, rates of HF hospitalization were 17.4% in the placebo compared to 9.9% in the 5mg and 10mg treatment arms. A composite of cardiovascular death or HF hospitalization paralleled these results with a rate of 19.6% in the placebo group versus 12.1% in the 5mg vericiguat group and 11% in the 10mg vericiguat group. Rates of
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any adverse effect were 77.2% for those in the placebo group and 70.3% for 1.25mg, 78.9% for 2.5mg, 73.6% for 5mg, and 71.4% for 10mg treatment groups. The most notable event was syncope, with 7 total patients in the treatment arms experiencing this compared to only 1 in the placebo group. Dosing was established at 10mg daily with these findings.
Another phase-2 trial, VITALITY-HFpEF, was a randomized, controlled trial that further evaluated quality of life measures seen in SOCRATES-PRESERVED. A total of 789 patients were treated with either vericiguat 10mg, 15mg, or placebo for a duration of 24 weeks. Endpoints evaluated included KCCQ physical limitation scores (PLS), adjusted to a 0-100 point scale, a 6-minute walking distance, as well as clinical outcomes of cardiovascular and non-cardiovascular death, hospitalizations for HF and non-HF reasons. Mean patient age was 72.7, with 59% being NYHA Class II and the remainder Class III. Mean follow up time was 149.5 days. No endpoints met statistical significance. The KCCQ PLS least-squares means after 24 weeks were 5.5 for 15mg vericiguat, 6.4 for 10mg vericiguat, and 6.9 for placebo.. Average distance increase for the 6-minute walk after 24 weeks was 16.8m for 15mg vericiguat, 26.2m for 10mg vericiguat, and 15.6m for placebo, with a least-squares mean difference between 15mg vericiguat and placebo of -5.5m. In the phase-3, multi-center, international, randomized, placebo controlled, double-blind study, 5050 patients with worsening HFrEF were given either vericiguat or placebo for safety and efficacy evaluation. Patients in the study group were administered verticiguat 2.5mg by mouth daily and titrated up to 10mg, then evaluated at weeks 2 and 4, and every 4 months after that. Enrollment began September 2016 and concluded in December 2018, with 66% being enrolled within 3 months of their HF hospitalization. Inclusion criteria was as follows: adults aged 18 or older, New York Heart Association (NYHA) functional class II-IV, ejection fraction (EF) less than 45%, elevated BNP level within 30 days of randomization, evidence of worsening HF as defined by hospitalization within 3 months, hospitalization between 3 and 6 months, or the need for IV diuretics within 3 months of randomization. Exclusion criteria included systolic BP less than 100mmHg, or already taking a soluble guanylate cyclase stimulator, a PDE-5 inhibitor, or long-acting nitrates. The primary outcome for this study was a composite of death from CV causes or hospitalization for HF.
The mean age for patients included in the study was 67.5 and 76% were male. The study included a variety of patients with diverse ethnic backgrounds including 23% Asian, 34% Eastern Europe, 17.5% Western Europe, 23.4% Asian-Pacific. Other baseline characteristics included a mean body mass index of 27.7, 58% with NYHA Class II, 40% with NYHA Class III, 85.8% had EF<40%. All patients were also continued on guideline-directed therapy with 60% being on triple therapy beta-blocker, mineralocorticoid antagonist and either an angiotensin converting enzyme inhibitor (ACEi), an angiotensin II receptor blocker (ARB), or an angiotensin receptor-neprilysin inhibitor (ARNI). Mean follow up time was 10.8 months. In the vericiguat arm, 35.5% of patients met the primary outcome, compared to 38.5% in the placebo group (hazard ratio (HR) 0.90, 95% CI 0.82-0.98, p = 0.02), with a number needed to treat of 33. Total hospitalizations for HF in the vericiguat were 38.3 events/100 patient years compared to 42.2 events/100 patient years in placebo HR 0.91, 95% CI 0.84-0.99, p = 0.02). Death from any cause was not statistically significant with a rate of 20.3% in the vericiguat group and 21.2% in placebo (HR 0.95, 95% CI 0.84-1.07, p = 0.38). Reduced HF hospitalization being statistically significant was likely driving the composite primary outcome. Drug interactions: PDE-5 inhibitors – increased risk of hypotension – Risk X: avoid combination. PPIs, H2 blockers, antacids – decreased absorption of vericiguat Notably vericiguat is a substrate for P-glycoprotein (Pgp) & breast cancer resistance protein (BCRP), though no drug interactions have been documented. Adverse Effects: Hypotension (16%); Anemia (10%) Pregnancy and Lactation: Do not use in pregnancy. Not recommended for breastfeeding.
Dosing: 2.5mg, 5mg, and 10mg tablets – target dose 10mg Take medications once daily, at the same time, with largest meal of the day. If a dose is missed, do not double up doses. Storage: Store at room temperature (20-25 degrees Celsius). Temporary range between 15-30 degrees Celsius permitted.
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Dosages and Cost: Tablet cost (AWP) = $23.32/tablet for any strength (2.5mg, 5mg, 10mg)
Summary/Use in clinical practice: The treatment algorithm for HF patients is complex, covering many classes of medications. Patients with HFrEF seem to get the most benefit from the majority of medications, while patients with HFpEF are treated similarly without the same level of supporting data. Vericiguat still falls into this role, with its phase-3 trial data coming from the HFrEF patient population. With its once daily dosing, minimal side effects and a proven ability to reduce cardiovascular death or HF hospitalization, it can be another add-on therapy candidate for patients who are already on maximally tolerated guideline directed therapy. Its novel pathway targeting sGC may also prove to be of benefit, with opportunities for unique monitoring parameters as a gauge of patient health. In a network meta-analysis comparing vericiguat with sacubitril/valsartan and sodium-glucose co-transporter-2 inhibitors based on their respective phase 2 and phase 3 trials, it was concluded that neither therapy is superior to the other for the prevention of cardiovascular death or HF hospitalization.7
The addition of vericiguat to therapy options that patients with HF can try in order to reduce morbidity and mortality allows for better therapy selection based on unique patient characteristics. The populations studied in the phase 3 trial had a higher morbidity and mortality risk (40% in NYHA Class III) than phase 2 studies with alternate therapies, opening a patient population that could see improved quality of life and reduced HF exacerbations leading to hospitalization. During the phase 3 trial, meeting the composite primary outcome resulted in a number needed to treat of 33. Additionally, vericiguat is a well-tolerated medication, making it a viable option for patients who are intolerant to other therapies in HF treatment. Caution should be used during titration for syncope events, or patients that are prone to falls or hypotension such as the geriatric population. It must also be considered whether an addon medication will increase pill burden for patients or be cost prohibitive. Reduced HF hospitalizations and possible quality of life improvement, demonstrated in phase-2 trials, though not statistically significant, could become clinically relevant as prescribing patterns increase. Melissa Dempsey, PharmD is a 2021 graduate
of Campbell University College of Pharmacy. m_ dempsey0518@email.campbell.edu Bibliography:
Armstrong PW, Lam CSP, Anstrom KJ, et al. Effect of Vericiguat vs Placebo on Quality of Life in Patients With Heart Failure and Preserved Ejection Fraction: The VITALITY-HFpEF Randomized Clinical Trial [published correction appears in JAMA. 2021 Feb 2;325(5):494]. JAMA. 2020;324(15):1512-1521.
Armstrong PW, Pieske B, Anstrom KJ, et al. Vericiguat in Patients with Heart Failure and Reduced Ejection Fraction. N Engl J Med. 2020;382(20):1883-1893. doi:10.1056/NEJMoa1915928 Aimo Q, Pateras K, Stamatelopoulos K, et al. Relative efficacy of sacubitril-valsartan, vericiguat, and SGLT2 inhibitors in heart failure with reduced ejection fraction: a systematic review and network meta-analysis. Cardiovasc Drugs Ther. 2020.
Gheorghiade M, Greene SJ, Butler J, et al. Effect of Vericiguat, a Soluble Guanylate Cyclase Stimulator, on Natriuretic Peptide Levels in Patients With Worsening Chronic Heart Failure and Reduced Ejection Fraction: The SOCRATES-REDUCED Randomized Trial. JAMA. 2015;314(21):2251-2262. Pieske B, Maggioni AP, Lam CSP, et al. Vericiguat in patients with worsening chronic heart failure and preserved ejection fraction: results of the SOluble guanylate Cyclase stimulatoR in heArT failurE patientS with PRESERVED EF (SOCRATES-PRESERVED) study. Eur Heart J. 2017;38(15):1119-1127.
Vericiguat. [package insert online]. Merck & Co., Inc. Whitehouse Station, NJ. Revised January 2021. https:// www.merckconnect.com/verquvo/coupons-samples. Accessed March 8, 2021. Vericiguat. In: Lexicomp [database online]. Hudson, OH: Lexicomp, Inc. http://www.crlonline.com/lco/action/doc/retrieve/docid/ patch_f/7063084?cesid=2lp12c4osJO&searchUrl=%2Flco%2Faction%2Fsearch%3Fq%3Dvericiguat%26t%3Dname%26va%3Dvericiguat. Accessed March 8, 2021.
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Member Spotlight Autumn Steen
PharmD, BCACP, CDCES, CPP Written by: Irene Park Ulrich PharmD, BCACP, CPP
The NCAP Ambulatory Care Academy is proud to highlight this the 2021 Ambulatory Care Practitioner of the Year Award Winner, Autumn Steen, Pharm, BCACP, CDCES, CPP. Autumn completed her undergraduate degree at UNC and received her PharmD degree from the UNC Eshelman School of Pharmacy in 2013. Upon graduation, she went on to complete a PGY1 Pharmacy Practice Residency in Ambulatory Care at Mission Hospital and MAHEC in Asheville, North Carolina. After spending two years as a clinical pharmacist in the Mission Medication Assistance Program, Autumn obtained a position as the a clinical pharmacist in the Mission Hospital Diabetes Education Center in 2016. She is Board Certified in Ambulatory Care Pharmacy (BCACP) and is a
Certified Diabetes Care and Education Specialist (CDCES). She is also a certified insulin pump trainer for many major pump devices and continuous glucose monitors (CGMs). In her role as the only pharmacist at the Diabetes Education Center, Autumn has been instrumental in creating programs and services unique to her skill set. Clinical services she initiated include starting clinical pharmacist practitioner services, diabetes education classes at a Mission member hospital in rural Spruce Pine, North Carolina, and starting a new-to-insulin post-discharge monitoring program. She was also integral in implementing a professional CGM program at multiple hospital sites. In addition to her clinical efforts, Autumn has been heavily involved in the multidisciplinary Association of Diabetes Care and Education Specialists (ADCES), formerly known as the American Association of Diabetes Educators. Her leadership roles have included serving as Chair of the local networking group in WestPage 31
ern North Carolina, and she is presently serving as the North Carolina Coordinating Body Finance Leader. Her role as an educator has extended beyond patient care, as she is also a preceptor for UNC Eshelman School of Pharmacy students and PGY1 Pharmacy Practice Residents at Mission Hospital. She was selected by the residents for the Spirit of Residency Award in 2016. Autumn embodies all that it means to be an ambulatory care pharmacist. Autumn is from a very small town in rural, Western North Carolina and went into ambulatory care pharmacy because she wanted to ultimately help manage chronic diseases in communities of need. Ambulatory care pharmacy, at its core, is about relationships and increased access to care, and those principles have been Autumn’s guiding light throughout her career. Please join the Ambulatory Care Academy Executive Committee in congratulating Autumn on this well-deserved award!
Reflections on the COVID-19 Pandemic Response by North Carolina Ambulatory Care Pharmacists Kimberly L. Nealy, PharmD, BCPS, CDCES, CPP Wingate University School of Pharmacy Jennifer A. Wilson, PharmD, BCACP Wingate University School of Pharmacy
North Carolina Ambulatory Care Pharmacists have been pioneers in the specialty for decades. Additionally, pharmacists practicing in this area have a berth of sub-specialties, protocols, and patient populations, resulting in rich service provision. It comes as no surprise that in 2020, during the global SARS-CoV-2 pandemic, the outpatient clinical pharmacists’ responses were varied and diverse. In the spring of 2020, pharmacists pivoted to develop innovative ways to continue providing optimal patient care, which now including protecting themselves, their patients, and the community from contracting the novel Coronavirus. We set out to explore strategies and barriers experienced by ambulatory care pharmacists during the first year of the pandemic and to garner information about plans for the foreseeable future.
A questionnaire sent to NCAP Ambulatory Care Academy members revealed that most of the responders were providing both in office (88%) and tele-
phonic patient care (100%) going into the fall of 2020. Additionally, several responders reported they were also providing video visits (55%) for their patients at that time. Barriers of new care models ranged from patient apprehension of coming in to clinics for visits or lab work to frustration over the transition from office-based to virtual care. Technology challenges associated with working virtually included the use of personal or unlisted phones by providers, which often resulted in confusion or concerns from patients. In some cases, phone and virtual visits have resulted in more difficulty providing hands-on, directly observed device training for products like injectables, inhalers, and self-monitoring. Unsurprisingly, patients may have limited access to or comfort with the technology required for video visits and telephonic visits limit non-verbal communication. There have also been several factors which have indirectly affected routine ambulatory care pharmacy practice, such as a decrease in access to pharmaceutiPage 33
cal samples as well as copay and trial cards.
Despite the challenges and downfalls during the pandemic, there have been some positive outcomes of the changes in practice. The increased provision of telephonic and virtual health offerings has given alternative avenues for care for patients who may have previously had barriers to transportation or time for appointments. By the nature of these visits, time commitment to the visit is usually decreased for the patient, as they aren’t required to drive to and from the clinic setting. This may allow for more visits in a day with various providers and an increased time available overall. Additionally, when patients are at home, they are more likely to be able to access medications, self-monitoring devices and logs, and food labels more readily. While clinics are now mostly back to allowing in-person appointments, many are still offering these expanded opportunities, which can potentially reach a broader patient
base, enhancing patient access to care.
Additionally, the pandemic has emphasized the important role pharmacists in regard to services such as point of care testing and immunizations. Pharmacists in all settings are integral members of the healthcare team. As such, we have risen to the occasion to increase involvement with services such as COVID-19 testing and immunization administration. The pandemic has increased the public’s awareness of the role pharmacists play in providing healthcare services. In the fall, vaccination efforts were primarily focused on encouraging and administering the influenza vaccine to minimize the impact of a potentially difficult flu season in the midst of the pandemic. With Emergency Use Authorization of three COVID-19 vaccines in the United States, the focus has now shifted to encouraging pharmacist involvement, including ambulatory care pharmacists, in helping with mass vaccination
efforts and public education regarding the vaccines.
Ambulatory care pharmacists, along with pharmacists across all settings, have faced many challenges in the wake of the pandemic. However, we have employed creative strategies to overcome these barriers, many of which will enhance patient care in a post-pandemic era. This includes more routine use of technology as an alternative means to provide patient education and care. Patients have more flexibility and autonomy to choose visit types which suit their personal needs or preferences. Pharmacists remain among the most accessible healthcare providers; broadened care provision via multiple strategies has helped to expand this access throughout our state. Heightened public and legislative awareness of the role pharmacists can play in providing healthcare services will hopefully result in increased opportunities in the future.
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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.
407.878.1662 | info@vucahealth.com | www.VUCAHealth.com
State Comparison Chart COVID Vaccination Administration
Adults Receiving One Dose of the Vaccine (Biden Administration Goal 70%) Updated June 14, 2021 Jurisdictions that Have Met or Jurisdictions with 50% or Jurisdictions with Less Exceeded the Goal of 70% of More Adults with One Dose than 50% of Adults with Adults with One Dose n = 35 One Dose n = 13 n=4 Vermont – 83.5% New York – 69.9% Wyoming – 48.2% Hawaii – 81.7% District of Columbia – 69.7% Louisiana – 47% Massachusetts – 80.4% Illinois – 69.3% Alabama – 46.7% Connecticut – 77.2% Virginia – 69.1% Mississippi – 44.8% New Jersey – 76.4% Minnesota – 68.5% Maine – 76.1% Delaware – 68.1% Rhode Island – 73.9% Colorado – 67.8% Pennsylvania – 73.4% Oregon – 67.7% New Mexico – 72.6% Wisconsin – 64% California – 72% Nebraska – 63% Maryland – 72% South Dakota – 63% New Hampshire – 71.6% Iowa – 62.6% Washington – 71.5% Puerto Rico – 62.2% Florida – 61.9% Utah – 61.7% Michigan – 61% Kansas – 60.8% Alaska – 59.5% Kentucky – 59.5% Arizona – 59.2% Texas – 59.1% Nevada – 59% Ohio – 58% Montana – 57.2% North Dakota – 54.6% North Carolina – 54.5% Oklahoma – 54.3% Indiana – 54% Missouri – 53.9% Georgia – 52.2% South Carolina – 52.2% Idaho – 51.3% Arkansas – 51.1% West Virginia – 50.5% Tennessee – 50.1% Page 35
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An educational series for ASHP State Affiliates | Join us for a complimentary CPE/CME Webinar!
Getting to Know the New JAKs on the Block: Pharmacy-Focused Insights for Atopic Dermatitis and Alopecia Areata Boston University School of Medicine’s Webinar Presentation at: North Carolina Association of Pharmacists
Date: August 12, 2021 | 12:00 - 1:00pm EDT Zoom Registration Link: https://bostonu.zoom.us/meeting/registertJ0qcOiprzgvEtxGxnXfCMPUT0PfcBZsob6f Learning Objectives
1. Explore the changing paradigm of AA and AD disease presentation and treatment approach. 2. Assess and interpret the latest clinical trial data among emerging oral agents in AA and/or AD and terms of therapeutic target, safety, efficacy, and tolerability. 3. Recognize the potential place in therapy and monitoring aspects for the emerging agents in AD and AA in order to effectively engage patients in shared decision-making for their treatment plan. 4. Outline a plan to proactively identify and remove barriers for health maintenance services and medication access in underserved patients with AA and/or AD.
Target Audience
This curriculum is intended for a broad audience of community pharmacists, dermatologic specialty pharmacists, and managed care professionals involved in the care and treatment of patients with AD and/or AA.
Speakers
Amanuel Kehasse, PharmD
Course Director Clinical Pharmacy Specialist Clinical Pharmacy Specialist in Autoimmune and Interstitial lung disease Boston Medical Center Health System Boston, MA
Accreditation ACPE
The University of Rhode Island College of Pharmacy is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. This is an application-based educational activity. Pharmacists will receive 1.0 contact hours (0.10 ceus) for the educational activity. No partial credit is available. ACPE Universal Activity Number (UAN): 0060-9999-21-023-L01-P ACCME Boston University School of Medicine is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. Boston University School of Medicine designates this live activity for a maximum of 1 AMA PRA Category 1 Credit™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
Acknowledgement
This activity is presented by Boston University School of Medicine and The University of Rhode Island College of Pharmacy and is supported by and independent educational grant from Pfizer.
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Peter A Lio, MD
Assistant Professor of Clinical Dermatology and Pediatrics Northwestern Feinberg School of Medicine Director, Chicago Integrative Eczema Center Founding Partner Medical Dermatology Associates of Chicago Chicago, IL
Boston University School of Medicine Barry M. Manuel Continuing Medical Education Office
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New Drug Monograph Ponesmiod (Ponvory™)
hours. It is excreted 57-80% in feces (16% unchanged) and 10-18% in urine (0% unchanged)
Potential concerns related to the use of ponesimod include transient bradycardia, infection, macular edema, elevated transaminase, hypertension, skin malignancies, and respiratory effects such as reduction in FEV1. (1)
Clinical Efficacy: Oral Ponesimod Versus Teriflunomide in Relapsing Multiple Sclerosis (OPTIMUM) is the first phase III study to evaluate the efficacy and safety of ponesimod. It was a multicenter, douBy: Dr. Nakiya T. Whitfield ble-blind, active-comparator, superiority randomized control trial that included 1133 patients aged 18 to 55 with multiple sclerosis (MS) with a relapsing course from the onset (relapsing remitting MS or secondary progressive MS). Additional inclusion In March 2021, the Food & Drug Administration criteria include an Expanded Disability Status Scale approved ponesimod (Janssen Pharmaceuticals), a (EDSS) score of 0 to 5.5, and recent clinical or MRI sphingosine 1-phosphate (S1P) receptor 1 modula- disease activity. (2,3). A few key exclusion points tor, similar to Gilenya® (fingolimod), Mayzent® (siinclude patients with significant medical conditions ponimod), and Zeposia® (ozanimod). Ponesimod is or therapies for such (e.g., cardiovascular, pulmoindicated for the treatment of adults with relapsing nary, immunological, hepatic, ophthalmological, forms of multiple sclerosis (MS), including clinically ocular), lactating or pregnant women, or patients isolated syndrome, relapsing-remitting disease, and with contraindications to MRI. Patients who met active secondary progressive disease. (1) eligibility criteria were randomized in a 1:1 fashion Ponesimod blocks the capacity of lymphocytes to to receive teriflunomide 14 mg by mouth once daily migrate from lymph nodes, reducing the number of or ponesimod 20 mg daily (after following a 14-day lymphocytes in peripheral blood. The mechanism dose titration). (4) by which ponesimod exerts therapeutic effects in MS is unknown but may involve reduction of lymThe primary endpoint of the study was annualized phocyte migration into the CNS. (1) relapse rate (ARR) based on the number of conImportant pharmacokinetic properties about the firmed relapses per patient year from randomizadrug include: tion to the end of the study. A confirmed relapse was defined as a new, worsening, or recurrent • Absorption: Ponesimod reaches maximum conneurological symptoms that occurred at least 30 centration 2-4 hours post dose and has an absolute days after onset of preceding relapse, lasted at least oral bioavailability of 84% with the 10mg dose. Ab- 24 hours, and was accompanied by a documented sorption is not affected by food. increase in the EDSS score. Safety assessments • Distribution: Ponesimod is highly bound to plasincluded treatment emergent adverse events. (2) ma proteins (greater than 99%) and is mainly Treatment with ponesimod reduced ARR by 30.5% distributed in the plasma fraction of whole blood. compared to teriflunomide (mean ARR, 0.202 vs It has a volume of distribution of 160 L. 0.290; rate ratio, 0.695 [99% CI 0.536-0.902]; • Metabolism: Ponesimod is metabolized extenP<0.001. Additionally, the proportion of patients sively by the cytochrome P450 system (CYP2J2, who experienced at least one treatment emergent CYP3A4, CYP3A5, CYP4F3A, and CYP4F12). Ponesi- adverse even was similar between the two groups. mod also undergoes direct glucuronidation (UGThe most common adverse events in the ponesiT1A1 and UGT2B7). mod group included a persistently alanine amino• Elimination: Ponesimod has a half-life of 33 transferase (ALT) at 1 and 15 days after the end of Page 38
treatment, nasopharyngitis, headache, and upper respiratory infection, increase in blood pressure, and dyspnea. Overall, adverse events leading to treatment discontinuations were more frequent in the ponesimod group (49 of 565 [8.7%] vs 34 of 566 [6.0%]).(2)
Overall, OPTIMUM showed that ponesimod is superior to teriflunomide on the primary endpoint of ARR. Ponesimod was also well tolerated, and safety results were in line with previous observations in its phase 2 study and other S1P receptor modulators in controlled studies. (2) Before therapy with ponesimod is initiated, a workup including a complete blood count, liver function tests; ophthalmic evaluation (fundus, including the macula), and echocardiogram should be obtained. Patients with pre-existing cardiac conditions (e.g., bradycardia, first or second-degree AV block, myocardial infarction, or heart failure) should be closely monitored in a clinical setting following the first dose of ponesimod. (1) Due to the risk of bradycardia, ponesimod should be gradually tapered for the first two weeks of therapy before the standard maintenance dose is achieved. (1)
14-day Starter Pack
Maintenance Dose
Titration Day Days 1 and 2 Days 3 and 4 Days 5 and 6 Day 7 Day 8 Day 9 Day 10 Day 11 Day 12, 13, and 14 Day 15 and beyond
In patients with moderate to severe renal disease, there were no clinically significant changes in the maximum serum concentration or the area under the curve of ponesimod; therefore, no dose adjustments are recommended in those with renal impairment. (1)
Other considerations when considering treatment with ponesimod include: • Infection - In patients with an active infection, treatment initiation should be delayed until resolution of the infection. If a patient has already begun treatment with ponesimod, consideration for interrupting treatment should be given if a serious infection develops. • Macular edema - If macular edema is diagnosed on ophthalmologic exam, individual risk and benefits should be assessed to determine if therapy should be discontinued.
If a patient misses fewer than 4 consecutive doses during the initial titration, resume treatment with the first missed titration dose and resume the titration schedule. If 4 or more consecutive doses are missed, reinstate treatment with a new starter pack at day 1 and complete first-dose 4-hour ECG monitoring in appropriate patients. If a patient misses fewer than 4 consecutive maintenance doses, resume treatment with the maintenance dosage. If 4 or more consecutive maintenance doses are missed, reinitiate treatment with a new starter pack at day 1 of the titration regimen and complete first-dose 4-hour ECG monitoring in appropriate patients.
Daily Dose 2 mg 3 mg 4 mg 5 mg 6 mg 7 mg 8 mg 9 mg 10 mg 20 mg
Ponesimod is available in a 14-day starter pack [2 mg, 3 mg, 4 mg (two each); 5 mg, 6 mg, 7 mg, 8 mg, 9 mg (one each); 10 mg (three each)] and as a 20mg tablet. The current average wholesale price of ponesimod is $323.34 per tablet.
For patients with mild hepatic impairment (ChildPugh A) no dose adjustment is needed. However, in patients with moderate to severe liver impairment (Child-Pugh Class B or C), treatment is not recommended. (1)
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Important patient counseling tips should include: (1)
• Ponesimod should be swallowed whole and may be taken with or without food. • Slow heart rate may occur (especially when first starting the medication).
• Ponesimod can increase the risk of infections. Contact the provider if symptoms of infection develop. • Receiving some live vaccines should be avoided while taking ponesimod. Be sure to be current on vaccines before starting therapy with ponesimod. • Follow the titration schedule closely. If doses are missed, consult with the pharmacist or other provider before resuming therapy. Write down the date you start taking ponesimod so it is easier to keep track of any day(s) you miss. • If more than 4 days of therapy is missed (either in the titration or maintenance phase), do not resume therapy without speaking to the provider.
Summary/Use in Clinical Practice: Ponesimod is a once-daily oral selective S1P1 modulator, used to treat adults with relapsing forms of MS including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. (5) Current guidelines for the treatment of MS recommend the use of disease modifying therapies for all people with relapsing forms of MS. (6)
When comparing ponesimod to other S1P receptor modulators, there are several similarities between the agents including the required baseline labs, adverse effects, and once daily dosing. There are also notable differences between the approved agents. For example, fingolimod requires patient observation for 6 hours following the administration of the first dose, whereas with ponesimod, this is only necessary for patients with pre-existing cardiac conditions. (7)
latory Care Resident at Duke University Hospital. Nakiya.Whitfield@duke.edu References:
1. Product Information: PONVORY(TM) oral tablets, ponesimod oral tablets. Janssen Pharmaceuticals Inc (per manufacturer), Titusville, NJ, 2021. 2. Kappos L, Fox RJ, Burcklen M, et al. Ponesimod compared with teriflunomide in patients with relapsing multiple sclerosis in the active-comparator phase 3 optimum study: a randomized clinical trial . JAMA Neurol. 2021;78(5):558. 3. Kappos L, Fox RJ, Burcklen M, et al. Ponesimod compared with teriflunomide in patients with relapsing multiple sclerosis in the active-comparator phase 3 optimum study: a randomized clinical trial [Supplemental Appendix 1]. JAMA Neurol. 2021;78(5):558. 4. Kappos L, Fox RJ, Burcklen M, et al. Ponesimod compared with teriflunomide in patients with relapsing multiple sclerosis in the active-comparator phase 3 optimum study: a randomized clinical trial [Supplemental Appendix 2]. JAMA Neurol. 2021;78(5):558. 5. Janssen Announces US FDA Approval of Ponvory (Ponesimod), an Oral Treatment for Adults with Relapsing Multiple Sclerosis Proven Superior to Aubagio (teriflunomide) in Reducing Annual Relapses and Brain Lesions [news release]. Janssen Pharmaceuticals; March 19, 2021. https:// www.janssen.com/us/news-center/press-releases. Accessed May 25, 2021. 6. Rae-Grant A, Day GS, Marrie RA, et al. Practice guideline recommendations summary: Disease-Modifying Therapies for Adults with Multiple Sclerosis: Report of the Guideline Development, Dissemination, and Implementation Subcommittee of the American Academy of Neurology. Neurology. 2018;90(17):777-788 7. Gilenya (fingolimod) [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; December 2019. 8. Mayzent (siponimod) [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; January 2021.
Additionally, unlike siponimod which requires CYP2C9 genotype testing prior to initiating therapy, ponesimod does not have additional requirements. (8)
Ponesimod is unique in that if treatment needs to be stopped, it leaves the blood within one week, with effects on the immune system wearing off in one to two weeks for most patients. This may offer additional flexibility and a distinct advantage in treatment management if patients need to receive vaccines, address potential infections, or begin family planning. (5) Nakiya T. Whitfield, PharmD is a PGY-2 Ambu-
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Albert Fulton Lockamy, Jr. sion. He represented pharmacists on the North Carolina Medical Care Commission for almost 35 years, “I have fought the good fight. I have on the NC Drug Utilization Review (DUR) Board, and on the National finished the race. I have kept the Association of Boards of Pharmafaith.” 2 Timothy 4:7. cy (NABP). In addition, he served as president of the North Carolina Albert Fulton Lockamy, Jr., 80, Pharmacists Association (NCPhA), passed away on Father’s Day, June the NCPhA Endowment, American 20, 2021. He was born on May 11, Pharmaceutical Association (APhA) 1941 at home on Mother’s Day in Clinton, NC. He graduated salutatori- Academy of Practice and Managean of Hobbton High School in 1959, ment, the North Carolina Board of Pharmacy, and Wake Pharmacists and attended University of North Association. He also was a member Carolina, Chapel Hill, where he of the Presidential Board of Adviearned a BS in Pharmacy in 1963. sors of Campbell University. Awards received include Wake Pharmacist Al loved God and grew up in Keenof the Year, National Association er United Methodist Church before transferring to Edenton Street United Retail Druggist Leadership Award, McKesson Leadership Award, Searle Methodist Church (ESUMC) upon Leadership Award, UNC School of marriage to his wife Ginger. He was a faithful member of the church choir Pharmacy Distinguished Alumni and Discovery Sunday School Class Award, and “Tar Heel of the Week” by The News and Observer. NCPhA before joining the Foundry Fellownamed Al “Pharmacist of the Year” ship Sunday School Class; these and awarded him the Bowl of Hygeia groups were like extended family to for his community service. He also him and he enjoyed being a part of received an Honorary Doctorate them. from Campbell University for his dedication and contributions to pharPharmacy was one of Al’s life long passions. He worked as a retail phar- macy. macist with Revco (now CVS) and Blue Ridge Pharmacy and mentored His other life long passion was many students as a preceptor, instill- travel. He loved to explore the world with his wife, Ginger, and daughters, ing in them his love of the profesGinny and Elizabeth, admiring the May 11, 1941 - June 20, 2021 Raleigh, North Carolina
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splendor of God’s creation in the majestic mountains, vast seas, sandy beaches, lush forests and beautiful flowers. He visited all 50 states, multiple European countries, and Australia. Every trip he made, Al knew someone or was connected to them in some way. He never met a stranger. He was always quick with his humor and had a story to tell from his travels or pharmacy days. He was a voracious reader, enjoyed singing in the choir at ESUMC, and was an amazing cook - his speciality was banana pudding. Al was preceded in death by his father and mother, Albert F. Lockamy Sr. and Elizabeth Carr Lockamy; and brother, Elwood C. Lockamy. Al is survived by his wife, Ginger; daughters, Ginny and Elizabeth; brother, Billy Lockamy (Kim); brother-in-law, Dr. Bill Lee (Colleen), and four nieces and nephews. The family would like to thank Dr. Scott Hoffman, Dr. Ujjawal Gandhi and his team at UNC Rex Hematology Oncology-Cary, and the many wonderful nurses at UNC Rex Hospital for the tender care they gave Al during his illness. If you would like to make a donation to the NCAP Endowment Fund in memory of Al Lockamy, click here.
Call for Articles North Carolina Pharmacist (NCP) is currently accepting articles for publication consideration. We accept a diverse scope of articles, including but not limited to: original research, quality improvement, medication safety, case reports/case series, reviews, clinical pearls, unique business models, technology, and opinions. NCP is a peer-reviewed publication intended to inform, educate, and motivate pharmacists, from students to seasoned practitioners, and pharmacy technicians in all areas of pharmacy. Articles written by students, residents, and new practitioners are welcome. Mentors and preceptors – please consider advising your mentees and students to submit their appropriate written work to NCP for publication. Don’t miss this opportunity to share your knowledge and experience with the North Carolina pharmacy community by publishing an article in NCP. Click on Guidelines for Authors for information on formatting and article types accepted for review. For questions, please contact Tina Thornhill, PharmD, FASCP, BCGP, Editor, at tina.h.thornhill@ gmail.com.
North Carolina Pharmacist is the Official Journal of the North Carolina Association of Pharmacists Located at: 1101 Slater Road, Suite 110 Durham, NC 27703 Phone: (984) 439-1646 Fax: (984) 439-1649 www.ncpharmacists.org Page 44
