North Carolina Pharmacist Volume 101 Number 3

North Carolina Pharmacist

Volume 101 Number 3 Summer 2020

Advancing Pharmacy. Improving Health.

2020 NCAP Convention Will Be Virtual

See Inside For Details

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 Dave Phillips PRESIDENT-ELECT Beth Mills PAST PRESIDENT Debra Kemp TREASURER Thomas D’Andrea SECRETARY Matthew Kelm BOARD MEMBERS Brianna Berish Courtney Bradley Shannon Brown Ouita Gatton Ryan Mills Holly Nunn Ann Marie Nye Vinay Patel Jennifer Wilson 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 101 Number 3

Summer 2020

Inside • From the President .....................................................................................3 • From the Executive Director ...........................................................................4 • Convention Information........................................................................................7 • Health literacy and Health Outcomes.....................................................................13 • Fostemsavir for Multidrug-Resistant Human Immunodeficiency Virus Type 1......17 • Member Spotlight...............................................................................................23 • New ASHP Policy................................................................................................25 • Drug Monograph...............................................................................................29

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North Carolina Pharmacist is supported in part by: • Pharmacists Mutual Companies ..........................................................6 • EPIC Pharmacies Inc .........................................................................12 • NCAP Career Center ...........................................................................16 • VUCA ..................................................................................................22 • Pharmacy Quality Commitment ........................................................24 • Pharmacy Technician Certification Board ........................................27

ADVERTISING For rates and deadline information, please contact Rhonda Horner-Davis at rhonda@ncpharmacists.org

•From the President • David C. Phillips, PharmD, BCPS

The Harvest As I awoke this morning and went downstairs to let our dog out, I was greeted by crisp, cool air as I opened the front door. FALL! While the equinox has not officially occurred, I cannot help, but to be excited about the changing seasons and weather. Fall is one of my favorite times of the year.

At the same time, the start of fall this year produces feelings of angst and fear. As fall approaches, so does flu season and a potential resurgence of COVID-19. We are also less than two months away from the 2020 presidential election, likely one of the most politically charged elections in history.

Despite these uncertain times, I could not be more excited about being a pharmacist and a member of the North Carolina Association of Pharmacists (NCAP)! We are being recognized as key players in the fight against COVID-19 and other disease states. Pharmacists are at the table with other stake holders for Operation Warp Speed which was initiated to accelerate the production of a safe and effective COVID-19 vaccine as well as create a strategy for its deployment. The US Department of Health and Human Services also

amended the PREP Act to allow state-licensed pharmacists and pharmacy interns to order and administer vaccines to individuals ages three through 18 years, subject to several requirements.

With that being said, we must also continue our fight to be recognized as providers.

Another word used to describe the fall season is harvest, which can also mean an accumulated store or productive result. Over the past 6 months NCAP has embraced these challenges and produced a harvest of fruitful results. In July, we began the process of switching over to a new association management software (AMS), MemberClicks. In the coming months, you will notice significant changes to the website including an updated and modern look. Other new and exciting features will include a member engagement community, integrated event registration, and organization memberships. The new AMS will provide NCAP and members a better way to communicate and stay connected.

In October, NCAP will hold its annual convention VIRTUALLY. The COVID-19 pandemic has forced us to change our approach to the 2020 Convention, but this year will be no different than those of the past as we will still have quality, cutting-edge continuing education sessions and workshops.

The content will be spread out Page 3

over 6 days starting October 29th.

This year’s theme is “Prescription for Public Health” with numerous sessions focused on the role of pharmacists in improving NC public health. In addition to the live CE, there will also be scientific posters and the residency showcase. Abstracts for posters can be submitted until September 30th. Details about how posters and the showcase will be presented are coming soon. Look for convention registration to open in late September or early October once the transition to the new AMS is complete.

In the coming months, NCAP will hold its elections for the Board of Directors and Academies electronically, so be on the lookout for information in your email. Finally, in preparation for the next legislative session, the Board of Directors approved a detailed and comprehensive advocacy agenda during our August meeting. Visit NCAP’s policy and advocacy website in the coming weeks to learn more. In order for our advocacy efforts to be successful, we need ALL North Carolina pharmacists to be members of NCAP so our voice will be heard loud and clear by legislators. If you are not currently a member of NCAP, please consider joining today!

David C. Phillips, PharmD, BCPS

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

The ‘Real’ Bitter Pill It is Sunday afternoon, and as I am preparing to host one of our NCAP live-stream, continuing education programs, I am also sitting at my desk, fingers poised over the keys of my laptop, contemplating the best way to deliver this column’s message. It has been a little over four years since accepting the position of Executive Director for our Association; and it has been commonplace, for me to sign off on my previous NCAP columns, member letters, and other communications with the closing, “Pharmacy Proud”. I am indeed very proud of North Carolina pharmacists and pharmacy technicians who make up our noble profession.

I did not set out to work in association management. I, like most of you, set my sites on providing the best possible patient care; and later, I dedicated much of my career to teaching, the art and science of pharmacy practice, to new generations of pharmacists. Today, I am indeed extremely proud to be a non-traditional pharmacist, serving our profession in association management. Working in association management whether it is at the state level, such as here at NCAP, or on a national level, until

you are fully immersed in the behind the scenes work and privy to all the forces and tactics, both positive and negative, well to the outsider there’s just a lot of ‘the unknown’, a touch of the Great Oz scary sounds and belching smoke from behind the curtain.

I tell you how proud I am of who we are as a profession, because first and foremost, it is the truth.

Second, I want you to know that the next part of my column is written with a love and passion for our profession, despite that the message may be a bitter pill for some to swallow.

Over the years many individuals have been credited with quotes which essentially convey that success is not the absence of failure, that in essence, true success is best won by learning from and capitalizing on our failures. Perhaps this calls to mind the old saying, ‘if at first you don’t succeed, try, try again’. What is left unsaid, in this adage, typically used to spur children on toward learning many of their ‘firsts’ in life, is that you must adjust your actions as you try again, otherwise, you will continue to fail.

by believing in your cause, commitment and persistence. Hard work should not be confused with putting in the “real work” that is needed. In other words, hard work is not always a measure of success; or rather think of this way, many people and organizations work hard for years, but fail to achieve their goals. Whereas, the concept of putting in the necessary ‘real’ work, as defined, by Robert J. Kohler, Former Director for the Office of Development & Engineering for the Central Intelligence Agency, is when we focus on: 1) making commitments, 2) delivering on the commitments we make, and 3) securing commitments from others.

One of the primary reasons that NCAP exists is to provide a unified voice for pharmacy, and to advocate for change that lifts up our profession, and improves the lives of the patients we serve. We have all of the typical ingredients needed to support success in meeting our mission and vision. We have a sole pharmacy organization within our state to help unify our profession. We have goals, purpose and passion in spades. The NCAP Board of Directors, staff and volunteer leaders are all fully committed to carrying out our goals. We have There are also many recipes for recently invested in new technolsuccess. Just take a minute to plug ogy that will better help with or‘how to succeed’ into your favorite ganizing our causes, and serve to internet browser, and you’ll see better communicate with and conwhat I mean. Often these tenets nect our members. for success include such things as goal-setting, getting organized, We have our failures, too. Although having a purpose, keeping the faith our Association has a very strong Page 4

organizational health, we still struggle with two extremely essential elements: a) membership numbers and b) financial support, as well as grass roots work, by members, for our advocacy agenda. This coming year NCAP has an even more robust advocacy agenda. You can learn more by following our Legislative & Policy Update newsletters, which are published monthly. This past year, we had two major pieces of legislation: a) our collaborative practice modernization bill, which lost traction almost immediately because of a more organized, louder group that expressed opposition; and b) our pharmacy benefits manager bill, which lost support in the 11th hour during back room discussions with deeper-pocketed opposition. Honestly, another reason both of these important bills did not do as well as we had expected, was that pharmacy hurt itself. If PBMs don’t affect you, or if you are not interested in improving our collaborative practice, well then pharmacists tend not to act; and the outcome, we have fewer people in the pool to help us in our grassroots outreach, and a much smaller voice.

I will remind each of us that we are all pharmacists first, and when an issue impacts one faction of our profession, it tends to have a downstream ripple effect that impacts us all eventually. We need all of our profession supporting each of our pharmacy-related issues.

macy will continue to struggle to have their voice heard, no matter how strong an advocacy agenda is teed up by NCAP in 2021.

1. Making Commitments: as a pharmacist, technician or student pharmacist the easiest way to commit to helping advance our profession is to promise yourself that you will care as much about your profession as your patients.

2. Delivering on your commitments:

a. Join/maintain your membership with NCAP. We have not raised dues in many years. We have no immediate plans to raise dues. We need members! Our strength lies in our numbers. When I go into a legislator’s office one of the first questions they ask is how many members do I represent. Disappointingly, fewer than 15% of licensed, in-state pharmacists currently are members of NCAP. b. If you are not comfortable or have never advocated on behalf of your profession with a legislator, then consider attending the November 4th, Advocacy 101 Workshop as part of our upcoming Annual Convention.

c. Part of getting organized and influencing legislators has to do with money. It’s the cold hard truth. There are a handful of pharmacists giving to either our advoWe, meaning pharmacists, phar- cacy fund, Pill Pac or to campaigns macy technicians, student phar- for pharmacy-supportive legismacists, of North Carolina have lators. We are fortunate that we also failed, because we are not do- have a pharmacist, Wayne Sasser, ing the ‘real’ work as described by in the NC House of RepresentaKohler. The real work is not hard tives. One of the lessons learned to do, but it is spot-on when de- is that when members of the genscribed as ‘real’, since the reality is eral assembly show the ability to that without the following, phar- raise money, their party wants to Page 5

put them in positions that carry more power, such as committee chair positions. Maybe you have never given money to a campaign before, but I strongly urge every pharmacist and pharmacy technician to give what you can to Representative Sasser’s campaign. The politics of money is not pleasant to think about, but it is a lesson I have learned, and it is an area that pharmacy has failed to use their numbers to truly be influential. As an example, we have approximately 13,500 pharmacists licensed and working in North Carolina. If each pharmacist committed to give $100, which equals $8.33 a month, we could raise $1.35 million, making us one of the most powerful groups in the state. When you have that kind of money, the legislators listen. Please consider giving to the following campaign: https:// secure.anedot.com/sasserfornchouse/donate. We have made it very simple to donate.

3. Finally, secure commitments from others, by sharing this column or message, and having frank conversations with other pharmacists, pharmacy technicians and student pharmacists. You can do a lot, with just a little effort, in helping us to recruit others to join the Association, and to become more active in our advocacy work.

In closing, I’m looking forward to seeing many of you at our upcoming virtual convention, October 28-November 6. Until then take care, stay safe, and remember to vote and give generously.

Pharmacy Proud, Penny

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2020 NCAP VIRTUAL ANNUAL CONVENTION “Prescription for Public Health” Thursday, October 29 9:30-10:30

7:00-8:00 pm

New Practitioner’s Virtual Social Hour

Friday, October 30

Kickoff Coffee Hour with the NCAP President & Board Chairperson

President: David Phillips, PharmD Chairperson: Debra Kemp, PharmD

10:30-11:30

Keynote Session “Pharmacists as the Prescription for Improving the Health of North Carolina”

Speaker: Amanda Fuller Moore, PharmD

12-1pm

State of tobacco use and vaping in North Carolina

Speaker: Pete Koval, PharmD

2-3 pm

Emergency Preparedness and Response the Food & Drug Administration Way: A Public Health Perspective on the COVID-19 Pandemic

Speaker: Kelly Ngan, PharmD, MPH, CPH 6:30-8:30 pm

Workshop 1: Are You Too Small for Telehealth?

Perhaps Not! Hosted by: the NCAP Independent Pharmacy Network

Instructor: Michelle Fritsch, PharmD

8-10 am

Residency Showcase Block 1 Sessions

10-11am

Expanding Pharmacists’ Role for Providing Hormonal Contraception

Speaker: Mollie Scott PharmD, BCACP, CPP, FASHP 1-2pm

Expanding Pharmacists’ Role for Providing PrEP/PEP

Speaker: Matt Martin 4-6pm

Residency Showcase Block 2 Sessions

6-8pm

All Hallows’ Eve Virtual Costume Party and Games

Sunday, November 1

1-3pm

Workshop 2: Immunizations Update and Toolkit Application

Instructors: Katie Trotta, PharmD, Beth Mills, PharmD, BCACP, CPP, Tara Baran, PharmD

3-6pm

2:00-3:00 pm

Facilitators: Ritesh Patel, PharmD, Bobby Rawls, PharmD

Speakers: Michelle Rager, PharmD, BCPS, CDCES, CPP, Mackie King, PharmD, BCPS, AAHIVP, CPP

NCAP Independent Pharmacy Network (IPN) Business Meeting

Monday, November 2

12 -1 pm

COVID-19 Best Practices in the “New Normal”

Speakers: Kelsey Ohman, PharmD, Larren Suh, PharmD, MS, Zach Deyo, PharmD, BCPS, CPP

1-2 pm

Pharmacist Remote Product Check of Sterile Compounded Products During COVID-19

Speaker: Samuel Eberwein, PharmD, MS, BCPS, BCSCP, Nathan Barnes, PharmD

3-4pm

Late Breakers COVID -19 Update: Test, Treat, Vaccinate

Speakers: Rebekah H. Wrenn, PharmD, BCIDP, Shannon Holt, PharmD, BCPS-AQ ID, Ashley Marx, PharmD, BCPS, BCIDP

4-Until

Virtual Social Event: Netflix Binge Share

Tuesday, November 3 12:00-2:00pm

Round Tables—Session I

12:00-12:20 Topic 1 12:24-12:44 Topic 2 12:48-1:08 Topic 3 1:12-1:32 Topic 4 1:36-1:56 Topic 5

Shooting for the Stars: Pharmacists as Part of the Population Health Dream Team

3:30-5:30 pm

Round Tables—Session II

3:30-3:50 Topic 6 3:54-4:14 Topic 7 4:18-4:38 Topic 8 4:42-5:02 Topic 9 5:06-5:26 Topic 10

6:00-8:00 pm

Scientific Posters—Session I

7:00-Until pm

Virtual Social Event: Mixology 101

Wednesday November 4 10:00-12:00

Workshop 3: Advocacy 101—Taking Action

Instructor: Tony Solari, PhD, NCAP Lobbyist

12 – 1pm COVID-19, A State Board of Pharmacy’s Response During a State of Emergency and Global Pandemic

Speaker: Andy Bowman, PharmD 2:00-3:00

COVID-19 Impact on Vaccination Rates: National & State Patterns

Speaker: TBD

Friday, November 6

6:00-8:00

Scientific Posters—Session II

7:00-Until

Virtual Social Event—Favorite Reads in 2020 Thursday November 5

11:00-12:00

Legislative Panel Responds to Need to Expand Pharmacists’ Public Health Role

Facilitators: Penny Shelton, PharmD

NCAP Executive Director

Tony Solari, PhD

NCAP Lobbyist 12:00-1:00

Student-Resident Roundtables (No CE)

1-2 pm

COVID-19 Testing in the Community

Speaker: Franklin Roye, PharmD 6:30-8pm

New Practitioner Forum Business Meeting

Moderator: Brianna Berish, PharmD NCAP New Practitioner Forum Chairperson 6:30-8pm

NCAP Independent Pharmacy Network CE Session

Advanced Models of Care Speakers: Amina Abubakar, PharmD

William Ferrell, MD

Franklin Roye, PharmD

Moderator: Ritesh Patel, PharmD

11-2pm Health Systems Leadership Summit “NC Health Systems & COVID-19: Lessons Learned and Future Endeavors” 11-12pm

NC PAI 2030 Data

Stephen Eckel and Tyler Vest 12-1pm

Experiences with Managing in a Virtual World

Speakers TBD 1-2pm

COVID-19 Planning Into the Next Year Speaker(s)TBD 3-4pm

Infectious Disease Session I

Exact Topic and Speaker TBD 4-5pm

Infectious Disease Session II

Exact Topic and Speaker TBD

5-until

Virtual Social Event: It’s 5 O’clock Somewhere: Beer & Wine Tasting

For the first time ever all CE sessions and networking will be virtual. Our team has worked hard to organize a schedule full of engaging sessions for your professional development needs. Visit our Convention Website at https://ncapatwork.wixsite.com/website.

Please Note: We are transitioning to a new Association and Learning Management System (ALMS). We plan to open registration in conjunction with the launching of our new ALMS. Meanwhile, take a look at the annual convention agenda, and mark your calendar. Thank you for your patience, we anticipate that Convention Registration will open near the end of the September.

Poster Sessions Comparing Student Pharmacist and Pharmacist Perceived Role in Depression Screening and Suicide Prevention

Implementing Student-Led Legislative Week and Certificate Program for PharmD Candidates at the University of North Carolina Eshelman School of Pharmacy

Madalyn Bobeng, PharmD Candidate 2022; Nam Le, PharmD Candidate 2021; Mospan C, PharmD, BCACP, BCGP; Wingate University School of Pharmacy, Wingate, NC

Anita Yang, PharmD Candidate, Megan Wright, PharmD Candidate, Kevin Rhash, PharmD Candidate, Rachel Gilmore, PharmD Candidate, Colin Cabelka, PharmD Candidate

Impact of a pharmacist-driven rapid infusion rituximab conversion protocol at a multisite cancer center

Blinded continuous blood glucose monitoring in patients with type 2 diabetes on insulin or secretagogues with at-goal glycated hemoglobin

Donald C. Moore, PharmD, BCPS, BCOP, DPLA; Tsion Gebru, PharmD, BCPS, BCOP; Dragos Plesca, PharmD, PhD, BCOP, DPLA

Ifedolapo Fasina, PharmD Candidate; Ellen Montgomery, PharmD Candidate; Jennifer Kim, PharmD, BCPS, BCACP, BC-ADM, CPP; Obed Agyei, MD; Sharon Powers, BSN, RN-BC; Donna Plyler, MEd, RD, LDN, CDCES, CHC

Evaluation of an Interprofessional Geriatric Assessment Clinic Kali Hollingsworth, PharmD, Quyen Du, PharmD Candidate 2021.

Concurrent posaconazole and tacrolimus use in pediatric patients: a retrospective review to determine optimal dosing in pediatric bone marrow transplant patients

Effect of Anxiety and Psychological Disorders on Patients Hospitalized for COPD Exacerbation

Jane Chu, PharmD Candidate 2021; Arpita Patel RN, MSN, CPNP- AC, CPHON; Carmen Echols, PharmD

Lora D. Holloman, PharmD Candidate1 and Treavor T. Riley, PharmD, BCPS, BCCCP1,2 Knowledge, Attitudes, and Practices Faculty have towards Community-Pharmacy Residencies and Fellowships Anna Brown, PharmD Candidate; Tamera Hughes, PharmD, PhD; Jessica M. Robinson, PharmD; Jack Benjamin Prothero, PhD Candidate; and Stefanie Ferreri, PharmD, BCACP, FAPhA Student Pharmacist Knowledge and Perceptions of Methadone Use After Hospice Election Ellen Fulp, PharmD, MSPC, BCGP, Bernadette Lee, PharmD candidate

Use of Conventional Amphotericin Irrigations as Adjunctive Therapy in a Newborn with Refractory Renal Mycetomas: A Case Report Susan Ngo, PharmD Candidate1,2, Lauren Walter, PharmD 1, William Wilson, PharmD 1, Zachary Willis, MD 1 Three-Year Antibiotic Resistance Patterns Among Urinary Tract Isolates of Escherichia coli at a North Carolina General Hospital: Comparison of Infection Setting and Community Classification Adriana Muradyan, BS1, Alexandra S. F. Miller, BS1, Peter D. Ahiawodzi, PhD, MPH, CPH2, Dorothea K. Thompson, MS, PhD, JD3

Page 10

A Review: Leadership, Excellence, and Development (LEAD) Program to Achieve Diversity and Inclusion at the UNC Eshelman School of Pharmacy Elana Post, PharmD Candidate1; Madison Stanley, PharmD Candidate1; Christopher Wang, PharmD Candidate1; Carla White, BS Pharm RPh2

Ghassemi, PharmD, MSCR; Melissa Holland, PharmD, MSCR Evaluation of Community Needs for Student Run Free Health Services

Cross-sectional study analyzing lipid management and statin appropriateness in patients with diabetes

Aliyah Cruz, PharmD Candidate; Pamela Vega, PharmD Candidate; Jessica Stickel, PharmD; Akshara Kumar, PharmD Candidate, Jacqueline M. Zeeman, PharmD

Toneth Sang, PharmD Candidate; Sterling Feininger, PharmD Candidate

Possible Decrease in Apixaban Efficacy Following Roux-en-Y Gastric Bypass Surgery: A Case Report

Case Series: GLP1-RA use in ESRD

Casey Macfarlane, PharmD Candidate, Jacqueline L. Olin, MS, PharmD, BCPS, CDCES, FASHP, FCCP

Sterling Feininger, PharmD Candidate

Cost analysis of changing antibiotic administration from intermittent IV infusion to IV push

Student Pharmacists’ Perceptions on Pharmacist-Prescribed Hormonal Contraceptives and Their Professional Responsibility Brooke Balenger, PharmD Candidate 2021; Cortney Mospan, PharmD, BCACP, BCGP; Chris Gillette, PhD Investigating the Metabolic Effects of Sodium-Glucose Linked Transporter 2 Inhibitors (SGLT2i) in Mice Anh Nguyen – Pharm.D. candidate class 2021; Mentor: Sally McMillin – PhD – Basic Pharmaceutical Sciences Evaluation of the tobacco/nicotine assessment and cessation procedures through interdisciplinary efforts during COVID-19 pandemic in a family medicine clinic

Megan Day, PharmD/MSPH Candidate1,2, Ruthanne Baird, PharmD, BCPS1, Amy Pope, PharmD1, Kim Kelly, PharmD, BCPS1,2 Resources and Medication-Assisted Treatment Provided to Patients with Drug Use-Associated Infective Endocarditis Arefa Bacchus, Pharm.D. Candidate 1 , Lauren Harris, Pharm.D. Candidate 2 , Nakesha Spellman, MSCR, Pharm.D. Candidate 1 , Alexandria Wingler, Pharm.D. Candidate 3 , Alexandra Mihm, Pharm.D., BCPS 4 , Sarah Nisly, Pharm.D., BCPS, FCCP 3,4

Jennifer Wilson, PharmD Candidate1, Peter Koval, PharmD, BCPS, CPP1,2,3, Jennifer Kim, PharmD, BCPS, BCACP, BC-ADM, CPP1,2,3 Utilization of Pharmacists in Physical Therapy Didactic Curricula in the United States Dustin Wilson, PharmD, BCPS1,2; Emily Berberich, PharmD Candidate1; Arilyn Maier, PharmD Candidate1; Amish Patel, PharmD Candidate1; Brandon Turner, PharmD Candidate1; Brock Woodis, PharmD, BCPS, BCACP, BC-ADM, CDE, CPP1,2; Scot Sawyer, PT, DPT1 A Retrospective Comparison of Inpatient Management vs. Current Guidelines in Patients with Sickle Cell Disease Experiencing Acute Pain Anna Devane, Kim Kelly Pharmacist intervention on completion of microalbumin collection in a primary care setting Abigail Comer PharmD/MSCR Candidate; Emily

Page 11

SCIENTIFIC POSTERS Session I Tuesday, November 3 6:00 PM - 8:00 PM Session II Wednesday, November 4 6:00 PM- 8:00 PM

Roundtables Topics Tuesday November 3 Session I 12:00-2:00 PM Session II 3:30-5:30 PM PBM Tips & Tactics COVID POCT (workflow, policies, procedures) New Services in Community Pharmacy (CCM, TOC) Telepharmacy Remote Pharmacist IV Product Verification Managing Substance use Disorder via Telehealth Tobacco Cessation Counseling & Management Involving Students and Residents in a Diabetes Registry: a Population Health Perspective Drive-up INR Monitoring Services During COVID19 A Bill for Pay Parity for Pharmacists-provided Patient Care Services

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Health literacy and health outcomes: Current data on evidence-based interventions still lacking

By: Marianna Gray, Dr. Jordan Masterson, and Dr. Aubrie Rafferty Scope of Problem Health literacy has been defined as “the degree to which individuals have the capacity to obtain, process, and understand basic health information and services needed to make appropriate health decisions�.1 Approximately 90 million Americans demonstrate low health literacy and, given ongoing discoveries of its associated negative health outcomes, health literacy is noted as a key issue under the objective of improving health communication in the newly released Health People 2030 initiative for creating a healthier nation; The disparity of low health literacy was also included in the Healthy People 2020 objectives.2 Low health literacy has been linked to numerous poor health outcomes by many researchers.

Across disease states and patient populations, low health literacy

significantly contributes to medication nonadherence and has been found to increase mortality nearly two-fold in the geriatric population specifically.3,4 In 2017, Cox et al. discovered a correlation between low health literacy and increased 30-day unplanned healthcare utilization after hospital discharge in patients with heart failure.5 Low health literacy among parents has been associated with poorer care measures in children with asthma.6 Hope et al., noted that the inability to read prescription bottles and auxiliary labels was associated with a higher rate of cardiovascular-associated emergency department (ED) visits, whereas adequate medication knowledge and adherence were associated with a lower rate of ED visits in a congestive heart failure population.7 Of note to pharmacists is that poor health literacy significantly increases the likelihood that patients are unable to identify their medications Page 13

compared to those with adequate health literacy.8

Opportunities for Pharmacy

Data on the association between low health literacy and poorer health outcomes is vast; however, information on best-practice health literacy interventions and how pharmacists can help address this public health concern is sparse. While early efforts focused on how to improve health literacy directly via health promotion actions such as health education and social mobilization, perhaps it is time to shift the focus to how health care is delivered to and individualized for patients.9 A specific focus should lie on health care providers striving to meet patients where they are and delivering care at a health literacy level that is appropriate for individual patients. While pharmacists may not be equipped to directly improve the health liter-

acy of the millions of Americans that are affected by this disparity, they can improve methods of delivering health care to better meet patients where they are. Bell et al. conducted a study comparing the current standard of care to an enhanced, multipart intervention consisting of medication reconciliation, a medication understanding assessment, discharge counseling with an illustrated medication schedule along with patient-practice filling a pillbox, and discharge follow-up, including an assessment of medication adherence and other problems.10 All parts of the intervention were led by pharmacists. It was concluded that the intervention was effective in decreasing unplanned health care utilization, mainly emergency room visits, in individuals with low health literacy.10

the use of images along with simple text are effective in improving medication understanding and direction recall.13,14 Illustrated medication lists have been found to improve self-efficacy, medication adherence, and medication understanding in those with low health literacy levels in each of the four domains assessed with the Medication Use Questionnaire: knowledge of medication indication, strength, units, and frequency.15,16

written to the fifth-grade reading level. Patients will be assessed for medication understanding prior to hospital discharge and soon after, once the patient has returned home, via a follow-up phone call.

The hope is that the intervention will improve medication understanding, addressing the health literacy dilemma, and ultimately improving health outcomes and potentially decreasing health care utilization. The authors ask that any efforts made and research conducted aimed at improving Moving Forward health literacy be shared publicly with others so that the pharGiven the abundance of growing macy community can advocate data on negative health outcomes as a whole for patients with low associated with poor health liter- health literacy and stress that a acy, a clear need exists to develop significant gap exists within this practices and protocols for deliv- patient population that warrants ering health care more effectively more research. to the low health literacy population. Pharmacists are well-posi- Authors: Marianna Gray, PharmD Medication counseling is a key tioned to develop innovative ways Candidate 2021 at Wingate Unirole played by pharmacists in de- to do this across health care set- versity School of Pharmacy livering health care to patients. tings. With creativity, dedication, ma.gray088@wingate.edu; JorData has shown that patients with diligence, and maintaining a pa- dan Masterson, PharmD, BCPS Jorlow health literacy are more likely tient-centered mindset, the phar- dan.Masterson@hcahealthcare. to have lower levels of medication macy community can help combat com, Aubrie Rafferty, PharmD, understanding, which is essential the negative health outcomes that BCPS for the safe and effective use of have been linked to poor health Aubrie.Rafferty@hcahealthcare. medications.11 According to Kri- literacy. com palani et al., 2006, “techniques are needed to better educate The authors plan to conduct re- References low-literacy patients about their search into this public health dimedications as a potential strat- lemma in the health system set- 1. Ratzan S, Selden CR, Zorn M, egy to enhance adherence.�8 One ting by creating patient-specific Parker RM. National Library of technique that pharmacists can medication lists appropriate for Medicine Current Bibliographies use is providing patient-centered low health literacy patients. The in Medicine: Health Literacy. Namedication counseling with med- researchers will screen patients tional Institutes of Health. 2000. ication lists enhanced for the low admitted to the hospital for low 2. Healthy People 2030 [Internet]. health literacy population. Rec- health literacy and randomize Washington, DC: U.S. Department ommendations from the ad hoc qualifying patients to either cur- of Health and Human Services, committee on health literacy for rent standard of care discharge Office of Disease Prevention and the Council on Scientific Affairs instructions or an enhanced dis- Health Promotion; 2020 [citsuggest using large print, sim- charge process, which includes in- ed 2020 August 19]. Available ple wording, and images.12 Other structions using an individualized from https://health.gov/healtpublished studies have noted that medication list with pictures and hypeople/objectives-and-data/ Page 14

browse-objectives/health-communication 3. Jones JH, Treiber LA, Jones MC. Intervening at the intersection of medication adherence and health literacy. J Nurse Pract.2014.10(8):527-534 4. Sudore RL, Yaffe K, Satterfield S, Harris TB, Mehta KM, Simonsick EM, Newman AB, Rosano C, Rooks R, Rubin SM, Ayonayon HN, Schillinger D. Limited literacy and mortality in the elderly: the health, aging, and body composition study. J Gen Intern Med. 2006 Aug;21(8):806-812 5. Cox SR, Liebl MG, McComb MN, Chau JQ, Wilson AA, Achi M, Garey KW, Wallace D. Association between health literacy and 30-day healthcare use after hospital discharge in the heart failure population. Res Social Adm Pharm.

2017;13(4):754-758 6. DeWalt DA, Dilling MH, Rosenthal MS, Pignone MP. Low parental literacy associated with worse asthma care measures in children.

Ambul Pediatr.2007;7(1):25–31 7. Hope CJ, Wu J, Tu W, Young J, Murray MD. Association of medication adherence, knowledge, and skills with emergency de-

partment visits by adults 50 years or older with congestive heart failure. Am J Health Syst Pharm.2004;61(19):2043-2049 8. Kripalani S, Henderson LE, Chiu EY, Robertson R, Kolm P, Jacobson TA. Predictors of medication self-management skill in a low-literacy population. J Gen Intern Med. 2006;21(8):852-856 9. Nutbeam D. Health literacy as a public health goal: a challenge for contemporary health education and communication strategies into the 21st century. Health Promot Int.2000;15, 259–267 10.Bell SP, Schnipper JL, Goggins K, Bian A, Shintani A, Roumie CL, Dalal AK, Jacobson TA, Rask KJ, Vaccarino V, Gandhi TK, Labonville SA, Johnson D, Neal EB, Kripalani S. Pharmacist intervention for low literacy in cardiovascular disease (PILL-CVD) study group.

Effect of pharmacist counseling intervention on health care utilization following hospital discharge: a randomized control trial. J Gen Intern Med. 2016 May;31(5):470-477 11.Marvanova M, Roumie CL, Eden SK, Cawthon C, Schnipper JL, Kripalani S. Health litera-

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cy and medication understanding among hospitalized adults. J Hosp Med.2011 Nov;6(9):488-93 12.Ad hoc committee on health literacy for the Council on Scientific Affairs AMA. Health literacy: report on the council on scientific affairs. JAMA.1999;281(6):552557 13.Katz MG, Kripalani S, Weiss BD. Use of pictorial aids in medication instructions: a review of the literature. Am J Health-Syst Pharm, 2006;63:2391–2397 14.Houts PS, Doak CC, Doak LG, Loscalzo MJ. The role of pictures in improving health communication: A review of research on attention, comprehension, recall, and adherence. Patient Educ Couns. 2006; 61(2):173–190 15.Mohan A, Riley MB, Boyington D, Kripalani S. PictureRx: Illustrated medication instructions for patients with limited health literacy. J Am Pharm Assoc.

2012;52(5):e122-129 16.Mohan A, Riley B, Schmotzer B, Boyington DR, Kripalani S. Improving medication understanding among Latinos through illustrated medication lists. Am J Manag Care. 2014;20(12):e547-e555

Fostemsavir for Multidrug-Resistant Human Immunodeficiency Virus Type 1

By: Gabby Clark and Dr. Scott Perkins Abstract Objective: To review the pharmacology, efficacy, and safety of fostemsavir for the treatment of individuals with multidrug-resistant human immunodeficiency virus type 1 (HIV-1) infection who are heavily treatment-experienced.

Data Sources: Articles from Scopus (2004-July 2020) and PubMed (1948-July 2020) were identified using the search term fostemsavir.

hibitor, for the treatment of multidrug resistant HIV-1 infection in those who failed multiple regimens. Results at week 24 reveal 53% of the fostemsavir group achieved virologic suppression of 40 copies per mL of HIV RNA and at week 48, 54% of the fostemsavir group maintained virologic suppression making this a new FDA approved drug for the treatment of multidrug resistant HIV. Conclusion: Fostemsavir is a safe and effective antiretroviral therapeutic option when used in combination with other medications for the treatment of heavily treatment-experienced multidrug resistant HIV-1 infected patients.

Summary: Some individuals with HIV-1 begin to experience treatment failure quickly due to resistance and intolerance, requiring the initiation of a new regimen. Keywords: fostemsavir, human Phase 2 and 3 trials evaluated immunodeficiency virus type 1, fostemsavir, an attachment in- attachment inhibitor Page 17

Introduction Among the challenges faced by individuals who have been diagnosed with human immunodeficiency virus type 1 (HIV-1) infection is the availability of therapeutic options upon treatment failure. When drug resistance develops and the need for new medication therapy arises, selection of appropriate agents can be hindered by factors such as drug interactions or contraindications.1 The need for new therapeutic options is highlighted by the fact that, while the infection rate has slowed since the late 1990s, over 38 million individuals were living with HIV in 2019.2

On July 2, 2020, the US Food and Drug Administration approved

fostemsavir for individuals with multi-drug resistant HIV who are heavily treatment-experienced and have failed their current regimens due to resistance, intolerance or safety concerns.3 Pharmacology

Entry into a T-cell helper lymphocyte depends on the initial binding of the viral glycoprotein 120 (gp120) envelope to the CD4 receptor on the T-cell.4 Fostemsavir is a prodrug of temsavir and once activated, it works by binding to gp120, close to the CD4 binding site of the HIV cell. After binding, gp120 is in the closed state prohibiting the conformational change required for initial interaction between the virus and receptors on CD4 cells.5,6 This prevents the attachment and subsequent entry into T cells and other healthy host immune cells.

Fostemsavir must be used in combination with other antiretroviral agents and will not cause cross-resistance with other antiretroviral agents.5-8 Two-drug combination studies revealed additive or synergistic interactions, but no antagonistic interactions in vitro between temsavir and other antiretroviral agents.9 It is unlikely for fostemsavir to develop resistance to itself and can be introduced in a regimen regardless of HIV-1 tropism.6

temsavir is highly protein bound at an estimated 90%.5,6,11 At doses greater than or equal to 140mg, the half-life was between 4.5 and 16.9 hours.6 Fostemsavir’s mechanism of metabolism to temsavir is by hydrolysis and cytochrome P450-mediated (CYP3A4) oxidation.5,6,12 Due to CYP3A4 oxidation, severe hepatic impairment increases exposure to the drug, but does not justify dosage adjustments in the presence of hepatic impairment. While the effect of metabolism by age, race, or gender has not be assessed, caution is warranted in the geriatric population due to decreased physiological functions.5 Clinical Trials/Efficacy

Phase 2 A phase 2b, randomized, controlled trial was conducted to compare the efficacy and safety of various doses of fostemsavir with ritonavir-boosted atazanavir in patients with treatment-experienced HIV-1 infection.7 Patients were eligible for the study if they were 18 years or older, treatment-experienced (defined as exposure to 1 week or more of at least one antiretroviral medication), HIV-1 RNA of at least 1000 copies per mL, had been taking an integrase inhibitor for at least 1 week, and a drug-resistance genotype and phenotype indicating susceptiPharmacokinetics bility to ritonavir-boosted atazanavir, raltegravir, and tenofovir As a prodrug of temsavir, fostem- disproxil fumarate. All patients savir is not measurable in plasma received a backbone of raltegrabut once it has been hydrolyzed vir 400mg twice daily and tenoto its active metabolite, it is ab- fovir disoproxil fumarate 300mg sorbed. Steady-state plasma con- once daily. Of the 254 patients centrations were achieved 2-3 randomly assigned, 52 received days after the initial dose. Fos- fostemsavir 400mg twice daily, Page 18

50 received fostemsavir 800mg twice daily, 51 received fostemsavir 600mg once daily, 50 received fostemsavir 1200mg daily, and 51 received atazanavir 300mg with ritonavir 100mg. The primary endpoints of the study were proportion of patients with an HIV-RNA viral load less than 50 copies per mL (response rate) at week 24 and frequency of serious adverse events (ADEs) leading to discontinuation by week 24. No statistical analysis was performed for study endpoints.

Participants in this study had median age of 39, 60% were male, and 38% were white. Median baseline viral load was 4.88 log10 copies per mL with 43% of participants having >100,000 copies per mL and median CD4 count was 230 cells per ÎźL with 38% of patients having <200 cells per ÎźL. Overall, response rates were similar among all fostemsavir groups and the ritonavir-boosted atazanavir group by achieving HIV-1 RNA less than 50 copies per mL in 69-80% and 75% of patients, respectively. The percent of individuals with an HIV-RNA of less than 50 copies per mL at week 24 in each group were: 80% in the fostemsavir 400mg twice daily group, 69% in the fostemsavir 800mg twice daily group, 76% in the fostemsavir 600mg once daily group, 72% in the fostemsavir 1200mg once daily group, and 75% in the ritonavir-boosted atazanavir group. Additionally, investigators assessed the virological effects of fostemsavir as elective monotherapy for 7 days in small subgroup of patients from each arm prior to the beginning of the main study. The observed analysis of the medi-

an decrease in HIV-1 RNA from baseline was -0.69 log10 copies per mL for the 400mg twice daily group, -1.40 log10 copies per mL for the 800mg twice daily group, -1.28 log10 copies per mL for the 600mg once daily group, and -1.44 log10 copies per mL for the 1200mg once daily group. At week 24, the patients from the substudy were assessed to have 100% from the 400mg twice daily and 800mg twice daily groups, 90% from the 600mg once daily, and 89% from the 1200mg once daily group achieving HIV1 RNA less than 50 copies per mL. Adverse events resulting in discontinuation occurred in 2% of all participants but were not fostemsavir-related. Drug-related ADEs were reported in 34% of patients and 12% of patients experienced grade 2-4 ADEs with the most commonly reported being headache.

While this study was limited to individuals who had more therapeutic options remaining than the population for which fostemsavir is currently approved, it provided basic evidence of efficacy and safety to support future research.

In an extension of the study above, patients were continued from week 24 of therapy to week 48.10 At week 48, investigators assessed endpoints in addition to CD4 count change from baseline.

When comparing the response rates with those at week 24, patients taking fostemsavir showed similar virological efficacy to those taking ritonavir-boosted atazanavir at week 48. At week 48, 61-82% of patients achieved HIV-1 RNA less than 50 copies per

mL relative to 71% of patients in the ritonavir-boosted atazanavir group. The median increase in CD4 count from baseline in all fostemsavir groups was 165 cells per ÎźL compared to an increase of 142 cells per ÎźL in the ritonavir-boosted atazanavir group.

Patients with baseline HIV-1 RNA level less than 100,000 copies/ mL had a response rate of 73.9100% vs 96.3% in the fostemsavir groups and boosted groups, respectively. Those with baseline HIV-1 RNA level greater than or equal to 100,000 copies/mL had a response rate of 60-90.5% vs 71.4%, in the fostemsavir groups and boosted groups, respectively.

Ultimately, over the course of 48 weeks, fostemsavir continued to provide favorable efficacy.

Phase 3 A phase 3, partially randomized, international, double-blind, placebo-controlled trial compared the efficacy of fostemsavir to placebo in patients with multidrug resistant HIV-1 infection.13 Patients in the study were 18 years of age or older and had undergone multiple treatments for HIV-1 infection, were failing their current regimen as defined by a HIV-1 RNA count of greater than 400 copies per mL and had no viable antiretroviral combination available due to exhaustion of at least 4 of the 6 classes.

Those with chronic untreated hepatitis B virus, HIV-2 infection, alanine aminotransferase or aspartate aminotransferase levels greater than 7 times the upper limit of normal (ULN), alkaline phosphatase levels greater than 5 times the ULN, and bilirubin levels greater than or equal to 1.5 times the ULN were excluded. In Page 19

total, 371 patients were assigned to either the randomized or nonrandomized cohorts. Patients in the randomized cohort were randomly assigned to either fostemsavir 600mg twice daily or placebo. All patients continued to received their current failing antiretroviral regimen for 8 days.

The primary endpoints were mean change in the log10 level of HIV-1 RNA from day 1 to day 8. After day 8, all patients in the randomized cohort were continued on fostemsavir 600mg twice daily and optimized background therapy. Patients in the nonrandomized group were selected to be in this group if they did not have any active therapeutic options. They received open-label fostemsavir 600mg twice daily with optimized background therapy beginning on day 1. Virologic response, frequency of serious ADEs, and ADEs leading to discontinuation were observed in patients at week 24 and 48. Subgroup analyses were completed in cohorts as well, which included patients with a viral load less than 100,000 copies per mL, viral load greater than or equal to 100,000 copies per mL, and CD4 count less than 20 cells per ÂľL.

Of the patients included, 8% had HIV-1 RNA level of less than 400 copies per mL and 26% had CD4 count <20 cells per cubic millimeter. At day 8 of therapy, patients in the randomized cohort taking fostemsavir achieved HIV1 RNA level reduction of 0.79 log10 copies per mL compared to 0.17 log10 copies per mL in the placebo group (95% CI: -0.81 to -0.44; P<0.001) from baseline to day 8. In the subgroup analyses of patients with baseline HIV-1

RNA level of more than 1000 copies per mL, there was a median reduction of 0.86 log10 copies per mL compared to the 0.2 log10 copies per mL in the placebo group at day 8. However, there was no difference detected relative to baseline demographics.

At week 24, virologic response of HIV-1 RNA levels less than 40 copies per mL was 53% compared to 54% at week 48. Higher response rates were seen in patient who had one active antiretroviral agent in their optimized background therapy while those with baseline viral loads greater than or equal to 100 000 copies per mL or low baseline CD4 count less than 20 cells per cubic millimeter had relatively lower response rates. Efficacy results at week 48 included increases in CD4 count by 139 cells per cubic millimeter, 62% of patients achieving HIV-1 RNA level of less than 40 copies per mL, and 84% of patients achieving HIV-1 RNA level of less than 200 copies per mL. Efficacy results reported in the nonrandomized cohort included response rates in 37% of patients at week 24 compared to 38% at week 48. Median increase in CD4 count at week 48 was 63.5 cells per cubic millimeter from baseline levels.

Frequency of ADEs were alike in the randomized cohort with 92% of patients experiencing at least one ADE. A greater number of serious ADEs was reported in the nonrandomized cohort than in the randomized cohort (44% vs 31%, respectively), with the majority caused by infections. Nausea and diarrhea were the most commonly reported drug-related

for the geriatric population as the clinical trials did not include a large number of patients 65 Studies have been completed to years of age and older.5,7,10,13 determine if fostemsavir is effective in patients who failed several Adverse Effects/Warnings/ antiretroviral drugs in multiple Contraindications classes available for the treatment of HIV-1. The data available Adverse events reported in clinsuggests that fostemsavir is a safe ical trials occurring in patients and effective therapeutic option taking fostemsavir included dicompared to the placebo for indi- arrhea, nausea, upper respiraviduals with multidrug resistant tory tract infection, headache, HIV-1 infection and efficacy was cough, nasopharyngitis, pyrexia, influenza, vomiting, bronchitis, maintained through 48 weeks. fatigue, back pain, and asthenia.5 Adverse events leading to disconDosing and Administration tinuation in a phase 3 study were Fostemsavir is administered infections which occurred more orally at a dose of 600mg twice commonly in the nonrandomdaily and must be taken in com- ized cohort (5%).13 Drug-related bination with other antiretroviral ADEs occurred in 3% of particiagents in a therapeutic regimen pants with the most concerning for the management of multidrug being immune reconstitution resistant HIV-1.5,13 There is no inflammatory syndrome (2%).13 established maximum dose for Nausea and diarrhea, considered fostemsavir due to lack of safe- drug-related grade 2-4 ADEs octy and efficacy for doses greater curred at the highest rate in all than 1200mg per day. Howev- patients at 4% and 3%, respecer, greater occurrences of QTc tively. During the clinical trial on prolongation are seen at doses safety and efficacy of fostemsaof 2400mg or more.5 There are vir, 10% of patients experienced currently no clinical trials that Centers for Disease Control and have been conducted in humans Prevention class C acquired imconcerning dosage adjustment munodeficiency syndrome-defor patients with hepatic and re- fining events and 7% died.13 At nal impairment. Toxicity studies week 48, fostemsavir-related have been completed in animals grade 2-4 ADEs occurred in 21% and suggest that fostemsavir is of all participants with the most well-tolerated relative to organ commonly reported among pardysfunction.5 Data on pregnancy ticipants being nausea in 4% and are limited to non-human studies diarrhea in 3%.13 Occurrences of in rats and rabbits that suggest significant QTc prolongation at there are not any effects to fetal doses of 2400mg twice daily and development when exposed to elevations of hepatic transamifostemsavir or temsavir.5 There nases in patients with hepatitis is a pregnancy exposure registry B or C virus co-infection were to evaluate the impact of fostem- reported.5 Caution and careful savir on pregnant patients. Dos- monitoring should be used in age adjustments are not required these specific populations. The ADEs of grade 2 to 4 in all patients receiving fostemsavir.

Page 20

safety of fostemsavir with medications of similar metabolism was assessed as a result of fostemsavir and its active metabolite, temsavir, being metabolized

by CYP3A4 enzymes. While fostemsavir and temsavir are not inducers or inhibitors of CYP enzymes, coadministration with CYP3A inducers decreases the plasma concentration of temsavir making its intended purpose less effective.5,6 Place in Therapy

While clinical trials have been conducted to evaluate the safety and efficacy of fostemsavir, the use of fostemsavir has not yet been included in guidelines. Optimal treatment in patients with multidrug failure is not widely agreed upon. However, current therapeutic guidelines indicate that in patients with multidrug resistance who do not have fully active antiretroviral options, delaying progression of disease and further resistance are the main treatment goals.14

Guidelines suggest that ibalizumab, a CD4 post-attachment inhibitor, can be an option for individuals with who have multidrug resistance and experience treatment failure.It is likely that a similar recommendation will be maintained for fostemsavir.

Fostemsavir has some key advantages over ibalizumab in that it is an oral agent instead of an intravenous agent. Furthermore, daily dosing of fostemsavir may encourage compliance in individuals who may be poor candidates for the every other week dosing, healthcare professional administered ibalizumab dose. Having a

favorable drug-drug interaction Campbell University College of profile also makes fostemsavir an Pharmacy & Health Sciences; integrative therapeutic option for Email: perkins@campbell.edu individuals with multidrug resistant HIV-1.5,6,10 References: While there are some clear advantages to fostemsavir compared 1. Fauci AS, Folkers GK, Lane H. to current therapy there are still Human Immunodeficiency Visome limitations to its use. For rus Disease: AIDS and Related instance, there are limited data Disorders. In: Jameson J, Fauci to compare the antiviral activity AS, Kasper DL, Hauser SL, Lonof fostemsavir to other antiretro- go DL, Loscalzo J. eds. Harrisonâ&#x20AC;&#x2122;s viral agents due to it only being Principles of Internal Medicine, tested in populations who have 20e. McGraw-Hill; Accessed July failed most drugs or drug classes 24, 2020. https://accesspharavailable and no future studies macy.mhmedical.com/content. have been registered in http:// aspx?bookid=2129&sectionclinicaltrials.gov.

Additionally, id=192025263 fostemsavir with optimized ther- 2. UNAIDS. Global HIV & AIDS staapy is less effective in patients tistics â&#x20AC;&#x201C; 2020 fact sheet. UNAIDS. who have virologic failure and Accessed July 27, 2020. https:// have no options left compared to www.unaids.org/en/resources/ those who still have some thera- fact-sheet. peutic options to consider.13 3. United States Food and Drug Administration.

Fostemsavir.

The lack of resistance associated Accessed July 23, 2020. http:// with the use of fostemsavir and www.fda.gov. the efficacy data available suggest 4. Tilton JC, Doms RW. Entry fostemsavir can be a valuable op- inhibitors in the treatment of tion for individuals for who have HIV-1 infection. Antiviral Res. failed multiple drug regimens. 2010;85(1):91-100.

While fewer patients are reach- 5. Rukobia [package insert]. Reing a stage in which they have search Triangle Park, NC: ViiV multidrug failure with few or Healthcare; 2020. no options left, fostemsavir pro- 6. Cahn P, Fink V, Patterson P. Fosvides an option that may provide temsavir: a new CD4 attachment benefit to individuals who need it inhibitor. Curr Opin HIV AIDS. without having to utilize in-clin- 2018;13(4):341-345. ic, intravenous therapy.14 7. Lalezari JP, Latiff GH, Brinson C, et al. Safety and efficacy of the Authors: Gabby Clark, Class HIV-1 attachment inhibitor prodof 2021 PharmD Candidate; rug BMS-663068 in treatment-exCampbell University College of perienced individuals: 24 week Pharmacy & Health Sciences; G_ results of AI438011, a phase 2b, clark1204@email.campbell.edu; randomised controlled trial. LanScott Perkins, PharmD cet HIV. 2015;2(10):e427-e437.

Clinical Assistant Professor, 8. Li Z, Zhou N, Sun Y, et al. ActiviPharmacy Practice; Co-Director, ty of the HIV-1 attachment inhibDrug Information Center itor BMS-626529, the active comPage 21

ponent of the prodrug BMS-663068, against CD4-independent viruses and HIV-1 envelopes resistant to other entry inhibitors. Antimicrob Agents Chemother. 2013;57:4172â&#x20AC;&#x201C;4180.

9. Sans B, Gong YF, McAuliffe B, et al. In vitro antiviral characteristics of HIV-1 attachment inhibitor BMS-626529, the active component of the prodrug BMS-663068. Antimicrob Agents Chemother. 2012;56(7):3498-3507.

10. Thompson M, Lalezari JP, Kaplan R, et al.

Safety and efficacy of the HIV-1 attachment inhibitor prodrug fostemsavir in antiretroviral-experienced subjects: week 48 analysis of AI438011, a Phase IIb, randomized controlled trial. Antivir Ther. 2017;22(3):215-223.

11. Nettles RE, SchĂźrmann D, Zhu L, et al. Pharmacodynamics, safety, and pharmacokinetics of BMS-663068, an oral HIV-1 attachment inhibitor in HIV-1-infected subjects. J Infect Dis. 2012;206(7):1002-1011.

12. Meanwell NA, Krystal MR, Nowicka-Sans B, et al. Inhibitors of HIV-1 Attachment: The Discovery and Development of Temsavir and its Prodrug Fostemsavir. J Med Chem.

2018;61(1):62-80.

13. Kozal M, Aberg J, Pialoux G, et al. Fostemsavir in Adults with Multidrug-Resistant HIV-1 Infection. N Engl J Med. 2020;382(13):12321243.

14. U.S. Department of Health and Human Services. Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents with HIV. U.S. Department of Health and Human Services. 2019. Accessed July 27, 2020. http:// www.aidsinfo.nih.gov/ContentFiles/.

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 Page 22

Member Spotlights

Ambulatory Care Academy Jenelle Hall Montgomery has worked as a clinical pharmacist with Duke Neurology Clinic since 2016. She completed her PGY1 Pharmacy Practice residency at Vidant Medical Center and PGY2 Ambulatory Care residency at New Hanover Regional Medical Center.

Dr. Montgomery initially started her post-residency pharmacy practice with both Duke Rheumatology Clinic and the Multiple Sclerosis (MS)/Neuroimmunology division of Duke Neurological Disorders Clinic. Two years ago, she followed her passion for helping patients with neurological disor-

ders to become a full-time clinical pharmacist practitioner in the neurology clinic. She has remained with Duke’s MS/neuroimmunology division and recently expanded her practice areas to include memory and movement disorders.

In the MS clinic, Jenelle provides medication education for patients who are initiated on high-risk MS medications and offers long-term follow-up visits. During these visits, she discusses MS treatment expectations, provides side effect and symptom management, and ensures patients complete timely lab monitoring. She finds the MS clinic to be rewarding because she is able to increase patient’s comfort with high-risk medications. In addition, through medication-related interventions, Jenelle is able to help minimize the risk of MS relapses.

In the Movement Disorders clinic, Jenelle is involved in a unique multidisciplinary clinic for patients diagnosed with Parkinson’s disease called the Benchmark Clinic.

This once-weekly clinic provides an opportunity for patients to rotate throughout the morning and receive an assessment from the clinical pharmacist, social work, occupational therapy, speech therapy, physical therapy, and a physician assistant. These disciplines Page 23

meet together in the afternoon to discuss recommendations with the patient’s neurologist, who then completes a visit with the patient to discuss implementation of these recommendations. This clinic has been well-received by learners on rotation with Jenelle as well as patients who attend the clinic. The Benchmark Clinic was able to continue successfully through the utilization of telemedicine during the COVID pandemic.

Finally, Jenelle has been an integral part of the Memory Disorders clinic in helping identify highrisk medications that can worsen cognition. She finds that she can provide the most assistance to caregivers who find it difficult to take on the task of managing medications for another person. She is able to meet with patients and their caregivers in the clinic and provide recommendations and resources. Memory disorders is another pharmacy practice area that Jenelle and learners find fulfilling and is an example of excellent utilization of a clinical pharmacist.

As the incorporation of pharmacists into specialty clinics continues to grow, Jenelle’s goal is to continue to demonstrate how pharmacists can make an impact on patient care in new and exciting outpatient clinic settings.

New ASHP Policy on Pharmacy Residency Programs and the Shortfall in North Carolina By: Dr. Ryan Mills The information below was discussed during the last Health System Academy meeting. The consensus was to have it published in our journal to make our members aware of the gap in North Carolina residency program availability.

0005.

During the House of Delegates meeting in June 2020, ASHP passed Policy 2027:

Number of North Carolina Students Seeking PGY1 Pharmacy Residency Training

Residency Training for Pharmacists Who Provide Direct Patient Care

Source: Council on Education and Workforce Development To recognize that optimal direct patient care by a pharmacist requires the development of clinical judgment, which can be acquired only through experience and reflection on that experience; further, Pharmacists who provide direct patient care should have completed an ASHP-accredited residency or have attained comparable skills through practice experience; further,

• UNC: 94

• Campbell: 53 • Wingate: 36

• High Point: 26

To support the position that the completion of an ASHP-accredited postgraduate-year-one residency be required for all new college or school of pharmacy graduates who will be providing direct patient care.

This policy supersedes ASHP policies 0701 and

According to the National Matching Service, 209 pharmacy PY4 students from the four schools and colleges of pharmacy in North Carolina entered the residency match in 2019-2020 (Class of 2020).

• Total: 209 students seeking a residency who are in training in NC Ref:

https://natmatch.com/ashprmp/ stats/2020schlstats-pgy1.pdf

Page 25

Gap in North Carolina Residency Program Availability In June 2020, Hope Ball and Lee Arphai (UNC Eshelman School of Pharmacy PY4 students) evaluated the ASHP Residency Directory to determine how many residency programs and residency slots are available in North Carolina. They followed up with Residency Program Directors to gather more information when the data was unclear on the website.

There are currently 164 PGY1 pharmacy residency program positions in North Carolina that are offered by 38 programs. Although not all North Carolina graduates stay in North Carolina, a goal would be to ensure that the number of positions offered in the state align with the number of students seeking residency programs. A gap of 45 positions currently exists.

National Matching Rates â&#x20AC;&#x201C; 2020

Number of applicants in the match: 6185

PGY1 Program Located in NC

# of Residency Positions Offered

Alamance Regional Medical Center â&#x20AC;&#x201C; Cone Health

2

Blue Cross Blue Shield of North Carolina

1

Atrium Health Cabarrus

Campbell University College of Pharmacy Cape Fear Valley Health System

Cape Fear Valley Medical Center Carolinas Medical Center

CaroMont Regional Medical Center Carteret General Hospital

Catawba Valley Medical Center

Charles George VA Medical Center Cherokee Indian Hospital, USPHS

Cone Health/ The Moses H. Cone Memorial Hospital Duke Regional Hospital

Duke University Hospital

Durham VA Medical Center

Fayetteville VA Medical Center

Federal Medical Center Butner

FirstHealth Moore Regional Hospital Harnett Health System In Clinic Rx

MH Mission Hospital, LLLP

Moses Cone Hospital - Cone Health

Mountain Area Health Education Center New Hanover Regional Medical Center Novant Health Forsyth Medical Center

Novant Health Presbyterian Medical Center Novant Health Rowan Medical Center Novant Health Specialty Pharmacy

Salisbury/W.G. Hefner VA Medical Center Southeastern Regional Medical Center UNC REX Healthcare

8 2 1 6 6 3 2 2 2 1 1 2 8 2 2 1 4 2 2 7 8 2 7 9 7 1 2 5 2 4

University of North Carolina at Chapel Hill

12

Vidant Medical Center

4

University of North Carolina Medical Center

16

Wake Forest Baptist Health

13

Womack Army Medical Center

1

WakeMed Heath and Hospitals Total PGY1 Residency Positions Available in NC

Page 26

4

164

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DRUG

Prepared by: Megan Day, PharmD Candidate Campbell University College of Pharmacy & Health Sciences

Rimegepant (NurtecTM) Monograph Prepared by: Megan Day, PharmD Candidate Campbell University College of Pharmacy & Health Sciences Generic Name rimegepant Brand Name NurtecTM

Classification1, 2 Calcitonin Gene-Related Peptide (CGRP) Receptor Antagonist Manufacturer: Biohaven Pharmaceuticals FDA Approval February 27, 2020

Indication1, 2 Approved Uses: Treatment of acute migraine in adults with or without aura.

Pharmacology1, 2 CGRP is released during an acute migraine attack, and is found to normalize after the migraine has resolved. CGRP is also known to transmit pain signals to the brain stem and modulate vasodilation of smooth muscle. However the exact mechanism of action for rimegepant, as a CGRP antagonist, in the treatment of migraines with or without aura is not fully understood.

Pharmacokinetics1, 2 Absorption The oral bioavailability of rimegepant is approximately 64%.

It has an onset of less than two hours with the maximum concentration absorbed at one and a half hours. When rimegepant is administered following a high fat meal, the time to maximum concentration is delayed and the maximum concentration reached is decreased in comparison to administration on an empty stomPage 30

ach; however, the clinical effect, from administration of rimegepant with food, is unknown.

Distribution Rimegepant is 96% protein-bound and the volume of distribution is 120 liters at steady state.

Metabolism Rimegepant is metabolized primarily by CYP3A4, and to a lesser extent CYP2C9, hepatic enzymes.

Elimination Rimegepant has a half-life of about 11 hours in healthy individuals. It is excreted at 51% unchanged in the urine and 42% unchanged in the feces without any major metabolites.

Clinical Efficacy3 A phase III, multicenter, double blind, superiority clinical trial was conducted by Croop, et al. from February to August 2018 to determine the safety, tolerability,

and efficacy of rimegepant for the acute treatment of migraines with or without aura. All participants were > 18 years old with a history of two to eight, moderate to severe migraines per month.

Participants had at least a oneyear history of migraines that began prior to the age of 50 years.

Exclusion criteria consisted of: medical conditions that could interfere with study assessments or put the participant at greater risk of a significant adverse event; treatment or evidence of alcohol or drug abuse within the past 12 months; drug allergy; or rimegepant safety and tolerability concerns raised from electrocardiogram (ECG) or lab finding.

Participants were screened and 1,466 were randomized 1:1 to receive rimegepant (N=732) or placebo (N=734). Participants were given one dose of study drug, and were instructed to self-treat their migraine, as well as record symptoms over the 48-hour period. If the migraine was not relieved after two hours, participants were allowed to use other rescue medications such as acetaminophen, NSAIDs, antiemetics, or baclofen. Within seven days after taking the study drug, participants were brought in for an end-of-treatment visit to evaluate their self-recorded migraine symptoms, medication adherence, safety and tolerability to the study drug. If participants did not have a migraine within 45 days of randomization, they were instructed to return the study medication and complete end of study measures. There were 669 participants that received rimegepant, and 682 participants that received placebo included in the modified intention-to-treat

(mITT) analysis.

Rimegepant was superior to placebo for freedom of pain two hours post dose (21.2% vs.

10.9%; CI 6.5, 14.2â&#x20AC;&#x2122; p<0.001) and freedom from their most bothersome symptom at two hours post dose (35.1% vs. 26.8%; CI 3.4, 13.2; p=0.0009). For every 10 patients treated with rimegepant, one patient will experience freedom from pain at two hours post dose (NNT=10) and for every 13 patients treated with rimegepant, one patient will experience freedom from their most bothersome symptoms two hours post dose (NNT=13). Of the three most bothersome symptoms photophobia, nausea, and phonophobia; photophobia was the most common (57%). Additionally, rimegepant was superior to placebo for all secondary endpoints except for freedom from nausea two hours post dose and no pain relapse from 2-48 hours post dose where a statistical inference could not be concluded. The most commonly reported adverse events were nausea, urinary tract infection, and dizziness. For every 50 patients treated with rimegepant, one patient is likely to experience an adverse event (NNH=50). There were no serious adverse events reported.

This study had several strengths: large sample population, similar baseline characteristic between groups, and assessment of multiple secondary endpoints. External validity is easily generalizable to the population most affected by migraines. The majority of participants were white females with an average age of 40 years who experience a moderate to Page 31

severe migraine without aura 4-6 times per month. Limitations include funder participation in study design, data analysis and interpretation, and drafting the article; lack of a standard of care treatment comparator; and inability to meet 95% power.

Drug Interactions1,2 Avoid administration with strong CYP3A4 inhibitors due to increased risk of adverse events from increased concentrations of rimegepant. When rimegepant is administered with a moderate CYP3A4 inhibitor, avoid another dose of rimegepant within 48 hours. Administration with strong and moderate CYP3A4 inducers should be avoided due to decreased efficacy from decreased concentrations of rimegepant.

Additionally, avoid inhibitors of P-glycoprotein and inhibitors of breast cancer resistance protein (BCRP) because rimegepant is a substrate of these transporters.

Co-administration with these inhibitors may result in increased concentrations of rimegepant.

Pharmacogenomics1, 2 Individuals with CYP2C9*2 and CYP2C9*3 alleles are poor metabolizers of CYP2C9 substrates.

However, since CYP2C9 is not the major route of metabolism for rimegepant, significant increase in exposure is not expected in individuals with a CYP2C9 polymorphism.

Adverse Effects1, 2 The most commonly reported adverse effect is nausea (2%).

Other reported adverse effects (<1%) include skin rash, hyper-

sensitivity, and dyspnea. Delayed serious hypersensitivity has occurred.

Dosing2 The orally disintegrating tablet (ODT) is recommended dose as 75 mg daily as needed given orally or sublingually. Do not take more than 75 mg in one day.

Avoid use in creatine clearance less than 15 mL/minute and in severe renal impairment (ChildPugh class C). Avoid in severe hepatoxicity.

Storage2 Rimegepant should be stored at room temperature of 20°C to 25°C (68°F to 77°F), however excursions of 15°C to 30°C (59°F to 86°F) are permitted.

Dosages and Cost A package containing eight 75 mg orally disintegrating tablets has an average wholesale market value of $1,020 or $127.50 per tablet. Manufacturer patient assistance program information available at https://www.nurtec. com/patient-assistance.

Summary/Use in Clinical Practice Current therapies used for the treatment of migraines include analgesics, NSAIDs, and serotonin receptor agonists. Not all patients respond to these treatments and some cannot tolerate these treatment regimens due to cardiovascular contraindications.

Therefore, it is important to have another medication available with minor adverse effects for patients with comorbid conditions or contraindications to other therapies.

Since the those who have migraines are 50-75% female, it is important to consider the use of rimegepant the patients of reproductive age, planning to become pregnant, or pregnant.4 There is no adequate safety and tolerability for the use of rimegepant in pregnant women.1 The study of rimegepant at the highest dose (300 mg/kg/day) in pregnant rats resulted in decreased fetal body weight and increased fetal variations. At lower doses in pregnant rats and rabbits, but still 45 times and 10 times the human dose respectively, there were no adverse effect on embryofetal development. There is no data available for the use of rimegepant in lactation.

While still under patent, rimegepant may be considered a last line treatment option for adults with acute migraine. When prescribing rimegepant, it is important to evaluate other medications that may disrupt the metabolism of rimegepant. Some medications and supplements to avoid are clarithromycin, grapefruit juice, azole antifungals, ritonavir, carbamazepine, phenobarbital, phenytoin, rifampin, and St. John’s Wort.

Currently, there is a trial that is evaluating effectiveness of rimegepant as a preventative treatment for migraine in adults. It is anticipated to be completed in January 2021. Future studies are necessary to determine the safety and effectiveness of rimegepant in pregnant women.

References

1. Rimegepant [package Page 32

insert]. New Haven, CT: Biohaven Pharmaceuticals, Inc; 2020.

2. Lexi-Drugs. Lexicomp Online [database online].

Hudson, OH: Lexicomp, Inc. http://online.lexi. com. Updated 2022. Accessed June 4, 2020.

3. Croop R, Goadsby PJ, Stock DA, et al. Efficacy, safety, and tolerability of rimegepant orally disintegrating tablet for the acute treatment of migraine: a randomised, phase 3, double-blind, placebo-controlled trial. Lancet.

2019;394(10200):737745. doi:10.1016/S01406736(19)31606-X 4. Burch RC, Buse DC, Lipton RB. Migraine: Epidemiology, Burden, and Comorbidity. Neurologic Clinics. 2019;37(4):631649. doi:10.1016/j. ncl.2019.06.001