TJHP - Volume 20 Issue 3

Advancing Pharmacy Practice and Education in Texas

VOLUME 20 | ISSUE 3 | FALL/WINTER 2021

Identifying, Assessing, and Reporting Human Trafficking in a Healthcare Setting Pooja H. Patel, PharmD Tzuchen Jou, PharmD Aleesha Ali, PharmD

Retrospective Evaluation of the Safety of Remdesivir Use in COVID-19 Patients with Renal Dysfunction Lakshmi Pillai, PharmD Vida Haddad, PharmD, BCPS, BCCCP Ronald Hall, PharmD, MSCS Jamie McCarrell, PharmD, BCGP, BCPS Maegan Whitworth, PharmD, BCPS

Do Not Crush List

Local Chapter News

Journal of the Texas Society of Health-System Pharmacists

New Drug List www.tshp.org/journal

TJHP: Texas Journal of Health-System Pharmacy Journal of the Texas Society of Health-System Pharmacists www.tshp.org/journal Stacey Mather, CAE Executive Director Leah Cody Professional Development Manager Paige Haines Membership & Communications Specialist

About TSHP The Texas Society of Health-System Pharmacists (TSHP) has been supporting health-system pharmacy in Texas since 1949, becoming one of the leading health-system pharmacy societies in the country that fosters leadership and education in pharmacy. What began as a small group of twenty-five dedicated hospital pharmacists coming together to learn and discuss professional issues, has grown to a dynamic health-system pharmacy organization that includes pharmacists, technicians, residents, students, retired pharmacists, educators, industry associates, and others passionate about the mission, vision, and core values of TSHP: Pharmacy Leaders. Transforming Patient Care. For more information on TSHP, please visit www.tshp.org.

TSHP Executive Committee: President Latresa Billings, PharmD, BCPS President-Elect Randy Martin, PharmD, BCCCP Immediate Past President Sarah Lake-Wallace, MS, PharmD, FTSHP Secretary Mallory Gessner-Wharton, PharmD, MS, BCPS Treasurer Mary Olumesi, PharmD, BCPS

TJHP Texas Society of Health-System Pharmacists 3000 Joe DiMaggio Blvd, Ste 30A Round Rock, Texas 78665-3920 (512) 906-0546

President-Elect Designee Rodney Cox, RPh, MS

TJHP Managing Editor Paige Haines Questions/Comments journal@tshp.org

Volume 20, Issue 3 Released: Dec 2021 ISSN: 2325-2804 Copyright © 2021 Texas Society of Health-System Pharmacists (TSHP)

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For information regarding TSHP’s privacy policy, please visit https://tshp.org/page/privacy_policy. Questions?

Contact TSHP at tshp@tshp.org.

Hardware Requirements: Any computer capable of running an A-grade web browser. Typically, a minimum memory of 1GB, and a processor speed of 1Ghz Software Requirements: Any of the following A-grade browsers: Chrome 45+ Edge 38+ Firefox 40+ Opera 15+ Safari 7+ No other plugins are mandatory.

Connectivity: Minimum 1MB/s speed downstream, 512KB/s speed upstream For full CE information (UAN numbers, objectives, CEUs, type), see the end of each applicable article.

Secretary-Elect Katie Morneau, PharmD, BCPS

TSHP President Latresa Billings, PharmD, BCPS TJHP Editor Todd Canada, PharmD

Continuing Education Information The Texas Society of Health-System Pharmacists (TSHP) is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing education.

To claim credit for CE, the participant must complete the course post-test, and complete a session evaluation using the provided link. Additional information on any available CE within this issue can be found at the end of each applicable article. Completion of this course requires access to an internet-enabled computer. Mozilla Firefox is the preferred browser.

A very special thank you to the authors and contributors of this issue, the TSHP Board of Directors, and the members of the 2020-2022 TSHP Editorial Advisory Board for their time and expertise in helping bring back the TJHP better than ever. It is because of you that we can truly advance pharmacy practice and education in Texas.

TJHP Editorial Advisory Board: Todd W. Canada, PharmD, BCNSP, BCCCP, FASHP, FTSHP, FASPEN(Chair) Haley Barnes, MS, CPhT Tina Beck, PharmD, MSCR, BCPS Abimbola Farinde, PharmD Caitlin Gibson, PharmD, BCPS Kathryn Pidcock, PharmD, BCPS Khanh-Hau Moss, MS, PharmD, BCPS Michelle Yazdchi, PharmD

VOLUME 20 | ISSUE 3 | FALL/WINTER 2021 | TJHP

TJHP is the official publication of TSHP. TSHP is a membership-driven state society of pharmacists, technicians, students, and professional colleagues who advocate for optimized patient care, professional practice, and public health. Membership in TSHP is open to all pharmacists and others who support TSHP’s mission and values. Annual membership dues are $180, of which $30 is for a subscription to the TJHP. The annual subscription rate (minimum 2 issues) to nonmembers is $40. The cost for single copies is $25.

Payments made to TSHP are not deductible as charitable contributions for federal income tax purposes. However, they may be deductible under other provisions of the IRS up to 33%. TSHP payment processing can be reached at (512) 906-0546 Monday through Friday, 8:00 AM to 5:00 PM Central Time or by contacting tshp@tshp.org.

To view membership status, login at www.tshp.org/login or contact the TSHP office.

CONTENTS

7 17 23 5

A Message from the TSHP President

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Local Chapter News

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Section Updates

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Identifying, Assessing, and Reporting Human Trafficking in a Healthcare Setting

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Retrospective Evaluation of the Safety of Remdesivir Use in Non-Critically Ill Patients with Covid-19 and Renal Dysfunction (REM-RENAL)

Latresa Billings, PharmD, BCPS

Pooja H. Patel, PharmD; Tzuchen Jou, PharmD; Aleesha Ali, PharmD

Lakshmi Pillai, PharmD; Vida Haddad, PharmD, BCPS, BCCCP; Ronald Hall, PharmD, MSCS; Jamie McCarrell, PharmD, BCGP, BCPS Maegan Whitworth, PharmD, BCPS

30 Abbreviated New Drug Application (ANDA) Approvals

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THANK YOU TO OUR SPONSORS

Authorship Authorship The Texas Journal of Health-System Pharmacists Editorial Advisory Board welcomes manuscripts from any source that are pertinent to the practice of pharmacy in hospitals and health systems. Manuscripts are subject to review by the Editorial Advisory Board and Editor(s) and will be accepted for publication only if they are believed to represent an important contribution to the literature.

Authors should follow the procedure checklist and submission instructions at www.tshp.org/journal. Authors without internet access may mail one (1) copy of their manuscript and a USB flash drive containing the manuscript file and supporting material to TJHP, 3000 Joe DiMaggio Blvd, Ste 30A, Round Rock, Texas 78665-3920. Authors may call (512) 906-0546 for assistance.

Accepted materials may not be published elsewhere without written permission from both the author and TSHP. The Editor(s) reserve the right to revise all manuscripts submitted, if necessary. The publisher assumes no responsibility for the statements and opinions advanced by contributors to the TJHP. For guidance on style, authors should consult the manuscript checklist, recent issues of the TJHP and American Journal of HealthSystem Pharmacy, and Scientific Style and Format: The CBE Manual for Authors, Editors, and Publishers, 6th edition. The AMA’s Manual of Style contain helpful advice on correct usage.

The views expressed by authors of contributions in the TJHP do not necessarily reflect the policy of TSHP or the institution with which the author is affiliated, unless otherwise specified. Authors, reviewers, Editorial Advisory Board Members, and TJHP Editors are required to declare potential conflicts of interest regarding manuscripts submitted for publication.

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VOLUME 20 | ISSUE 3 | FALL/WINTER 2021 | TJHP

A MESSAGE FROM THE TSHP PRESIDENT Greetings to my esteemed colleagues, As we continue to celebrate our contributions to healthcare during this month of December 2021, we have the opportunity to reflect upon the services that pharmacy teams render daily, but particularly over the last two years of the COVID-19 pandemic, and to take note of those who supported our profession along the way.

We want to say "THANK YOU" to the many pharmacy staff members and supporters within our workforce who were committed to lend provisions of strong healthcare services throughout this pandemic. The pharmacy workforce has included pharmacists, technicians, pharmacy students, academic educators, industry members, and administrative personnel.

While many pharmacy personnel continued to care of needs for the patients, customers, and services within the healthcare systems or academic systems, a host of representatives of our health-systems pharmacy departments accepted the call to serve countless hours during the rollout and sustainable tasks of the immunization processes. In academia, the educators and clinicians adapted their training courses to help to prepare the next generation of healthcare providers transitioning through their pharmacy schools.

Pharmacy students demonstrated high levels of resiliency accepting their adapted didactic and clinical learning experiences. Often, students' arrival to practice sites with eagerness to learn has been the influence upon the more seasoned pharmacy staff to persevere beyond the concerns of this period and inspired innovative thinking.

Throughout this season, our pharmacy industry members of TSHP and additional partners have continued to support our efforts by providing resources and information about their pharmaceutical products. A number of challenges that our industry colleagues face include, but not limited to, the opportunity to connect well with their necessary customers, having limited access to some facilities, and uncontrollable business attributes which may impact their services and supply chains. Yet, our dedicated TSHP Industry Members continue to be reliably present and available to assist our pharmacy departments and pharmacy workforce. For their service, we send to all our gratitude for partnering with and supporting our TSHP members and pharmacy colleagues during this season. Working together, we have demonstrated that the common slogan of this season has even greater merit exemplifying that "we are stronger together." Standing with my colleagues, I continue to applaud our pharmacy workforce and TSHP members who strive for excellence in services and performances rendered during these long-lasting unprecedented times. Simply, THANK YOU! Our battles within this COVID-19 pandemic are far from over. In the mist the demands of the pandemic, I am pleased to report that our dedicated volunteer TSHP members continue to partner in the journey moving forward the goals and strategies set forth by the TSHP Board of Directors. Our councils, committee, sections, and task-forces (CCSTs) have initiated discussions and are developing processes to align with specific portions of their strategic goals set to guide our organization for the immediate term and over the next five years.

The TSHP strategic goals are focused on the following: Cultivating an expansion of a vibrant and diverse membership population and seeking to address the healthcare-related disparities among the patient populations that we serve; Promoting the ongoing professional development and advancement of our pharmacy workforce through the assessment of innovative practice and service opportunities;

Fostering a progressive and innovative entity which advocates for recognition and advancement of pharmacy practice; Promoting the value of pharmacy practice in optimizing pharmacy care and partnerships with various industry entities for recognition of the value of pharmacy practice; Fostering a sustainable high performance TSHP team with provisions of resources, diversified revenue streams and a focus on optimizing financial health.

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A MESSAGE FROM THE TSHP PRESIDENT (Continued from Page 5) Newly released education, resources, and tools are readily available to our TSHP members as member benefits. Along with the inclusion of the release of our Medication History Certificate Program and Transitions of Care Certificate Program, a host of webinars and on-demand continuing education resources are available for members and non-members, with related fees in accordance to membership status. We plan to continue with unveiling upcoming webinars and continuing education opportunities in the coming months which may interest our members. We invite you to review our www.tshp.org homepage regularly to find out more about our resources available at your fingertips, as well as to follow TSHP-related and affiliate chapter activities and events on social media.

Like many organizations, TSHP's membership was impacted during this pandemic period. However, TSHP continues to move forward as we continue to find ways to engage and support members and reconnect virtually until we can meet again in-person. I challenge each of you to invite your colleagues to join or reconnect with other vibrant, engaged pharmacy professionals.

Within the interests for advancing the profession, TSHP members have new opportunities to volunteer for new certificate program taskforces focused on Controlled Substance Diversion and Hazardous Drug Management for 2021 to 2023. I encourage you to consider getting involved in TSHP. More information regarding Council, Committee, Section, and Task Force service will be sent in early December so stay tuned for that!

Beyond the benefits of education and resources, TSHP members have opportunities to be recognized for their contributions to the pharmacy profession by way of a variety of annual awards, as acknowledged by a group of their peers. We are currently seeking pharmacy department nominations for excellence in pharmacy service and attributes to be shared. In pursuit of providing recognition for exemplary programs that are training pharmacy residents, pharmacy residency programs are sought out to illustrate the excellence of their programs by applying for the TSHP Pharmacy Residency Excellence Award.

As we stride forward through this year, our sights are set on having a vibrant Annual Seminar to deliver an educational and professionally engaging seminar experience in the late spring, May 13 to 15, 2022 at the Kalahari Resort and Convention Center in Round Rock, Texas. We will remain diligent in review of events and circumstances surrounding the pandemic, with plans to govern our meeting arrangements accordingly with regard to the demands of the pandemic as we get closer to the seminar period. We will be sure to keep you all updated. At this point, we are looking forward to seeing you in person next spring. Be sure to save the date!

I want to thank all of the pharmacy workforce and TSHP members for all that you continue to do to provide for a better Texas tomorrow through service, education, and influence, as we are better together. Continue to be mindful of your well-being as well as those around you. I highly encourage members to reach out to me with any feedback, questions, or comments.

Sincerely,

Latresa Billings Latresa Billings, PharmD, BCPS TSHP President 2021-2022

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LOCAL CHAPTER NEWS

Austin Area Society of Health-System Pharmacists Hello from the Austin-Area Chapter!

Despite the events of the past year, AASHP has continued to be resilient in providing its members opportunities to network, gain continuing education, and get involved in the chapter. The chapter is proud of our 166 members working tirelessly within their practice to improve the health of the Austin community. Besides their typical day-to-day profession, our pharmacists have stepped up to be leaders in preparing and administering vaccines within community pharmacies, clinics, hospitals, and large-scale events. We are hopeful that with these efforts we will soon be able to return to live, in-person, events! In the meantime, we will highlight some of our “wins” for the past year and plans for upcoming activities.

Engagement In February we hosted a virtual trivia night! We used the platform Sporcle, which provided us with a virtual trivia host all the way from Minnesota. While our AASHP group excelled at the “Science” category, we could have used a couple more sports buffs in attendance!

Continuing Education CE continues to be at the forefront of our group activities, providing 6.5 hours over the past year. In April of 2020, we quickly transitioned our CE meetings to a virtual platform for synchronous meetings and discussions. Presenters included Ascension Texas PGY2 Residents, training to be experts in their specialty, and a Compliance Officer with the Texas State Board of Pharmacy.

CE Topics Have Included: Inhaled Corticosteroid Efficacy & Blood Eosinophil Values TSHP Law Update Gram Negative Bacteremia: Know When to Go to PO Dual Antiplatelet Agents for Ischemic Stroke

We have also held meetings sponsored by national companies including the Pharmacy Times, KedRab, RhoGAM, and Janssen. As the mask mandate waned, we were able to comfortably host in-person events at local restaurants while adhering to CDC Guidelines at that time. These events were much appreciated to reconvene after over a year of virtual meetings. However, with cases rising again, we have transitioned back to virtual meetings for our upcoming events.

Student Engagement The AASHP Chapter has a close relationship with the SSHP Chapter at the University of Texas at Austin's College of Pharmacy. Though we were unable to host our usual networking happy hour events, we continue to invite student members to CE nights virtually. We recently had a member attend the New Student Orientation at the College to educate students about the benefits of joining local organizations and our mission with the hopes of recruiting student members. We are proud of our student members who recently graduated in the class of May 2021!

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LOCAL CHAPTER NEWS

Austin Area Society of Health-System Pharmacists

Annual Seminar Our annual event is usually a cause for celebration; a full day of CE and booths from local and national sponsors. Speakers typically provide required Texas CE with topics including Texas law, pain management and controlled substance monitoring. Though our annual seminar was unfortunately cancelled last year we are excited to bring it back in February 2022. Austin members – keep a look out for more information!

Recruitment Over the past year, we have noticed our member numbers have started to decline. This is understandable given our focus on battling COVID19. With 2020 behind us we returned to 2021 with the goal of more frequent meetings and activities for member engagement. We have actively been recruiting new members through our monthly newsletter and plan to become more active on social media platforms. Austin – bring your friends to our next event!

New Executive Board Our new leadership team was inducted in July 2021 and is excited to navigate leading the Austin-Area Chapter during this season of change. To get to know the group, they would like to share their “Why AASHP/TSHP?”

Martha Evans President

Amanda Brown Education Chair

Laura Meadow New Practitioner Liaison

Cynthia Glover Immediate Past President

Lane Farrell Education Chair Elect

Elizabeth Lass Secretary/Treasurer

Sherry Weiser Pharmacy Technician-at-Large

Kathryn Litten Secretary/Treasurer Elect

Michael Kolandijan Pharmacy Studentat-Large

I have been a member of AASHP since I was a student member of UT-SSHP! When I was getting ready to finish my pharmacy residency, there was an opening for the New Practitioner Liaison on the AASHP executive board, and I decided to give it a shot! This couldn’t have been a better decision! Since joining the executive board of AASHP, I have been able to make wonderful connections with pharmacists and pharmacy technicians throughout the State of Texas. I truly don’t think I would have my current job if it wasn’t for AASHP. I am proud to serve as the AASHP President this year." - Martha Evans, AASHP President

"Throughout my career as a hospital pharmacist, the resources and support provided by TSHP have been essential to my professional growth. I believe that the best way to give back is to participate in the organization on a local level. Through AASHP, I have been able to start student rotations at my practice site, provide pharmacist feedback to state representatives, and engage with pharmacists and technicians from other areas of pharmacy practice. I have been honored to act as the Education Chair this year and look forward to serving as the AASHP President in the coming year!" - Amanda Brown, Education Chair "I joined AASHP when I moved to Austin in 2016 as a way to build my network. I did not go to pharmacy school in Texas, so I wanted to meet and connect with local pharmacists and pharmacy technicians by getting more involved. I love the AASHP Community and all the opportunities we offer for mentorship/leadership, continuing education and relationship building. I am excited to serve AASHP as the Secretary/Treasurer this year!" - Elizabeth Lass, AASHP Secretary/Treasurer "As a PGY2 Resident in Austin I had the opportunity to present at an AASHP continuing education dinner and saw first-hand the broad range of pharmacists in town who were able to network at the events. As the new Secretary/Treasurer Elect, I am excited to continue to expand upon this network and work together to improve pharmacy services and education in our community." Kathryn Litten, AASHP Secretary/Treasurer Elect

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VOLUME 20 | ISSUE 3 | FALL/WINTER 2021 | TJHP

LOCAL CHAPTER NEWS

Coastal Bend Society of Health-System Pharmacists The Coastal Bend Society of Health-System Pharmacists (CBSHP) held its Quarterly CE Program along with Medicine and Nursing Colleagues (Medicine-Nursing-Pharmacy) CE Quarterly on September 30, 2021. The CE program was held in conjunction with the monthly CBSHP Meeting.

Joy Alonzo (M. Engineering, PharmD, Clinical Assistant Professor, College of Pharmacy, Co-Chair Texas A&M Opioid Task Force and Director of Spring Outreach Mental & Behavioral Health Services, Texas A&M University) presented the program: "From Surveillance to Interventions: What is Working to Combat the Opioid Crisis & What Isn’t." Dr. Alonzo was accompanied by George Udeani (PharmD, DSc, FCP, FCCP, Clinical Professor, and Head of Pharmacy Practice, Texas A&M University) on a panel discussion. Mitchell Engle (MD, PhD, Anesthesiologist, and Partner, Institute of Precision Pain Medicine, Corpus Christi) presented the program: "Interventional Alternatives in Pain Medicine". Dr. Engle was accompanied by Kristy Aleman (MSN, DNP, Nurse Practitioner, Wellmed, Corpus Christi) on a panel discussion. Thomas Alexander (MD, Director Cardiology Fellowship Program and Cardiac Catheterization Laboratory, Corpus Christi) presented the program: "Management of Valvular Heart Disease." Dr. Alexander was accompanied by Christina Perry (MSN, APRN, FNP-C) on a panel discussion.

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TSHP NEW PRACTITIONER CORNER

TJHP Pearls for the New Practitioner Section The transition from a pharmacy student to a new practitioner represents an experience that learners prepare for within four years of pharmacy school. Extensive and rigorous didactic training imparted upon students provides a solid foundation of clinical knowledge, to be expanded through application during experiential rotations. While organizational involvement is optional, it represents an opportunity for the acquisition and execution of leadership skills – either an innate talent or learned approach. Moreover, organization-related experiences enable students to determine how they would like to impact their communities, whether through service learning, fundraisers, legislation advocacy, education, or comradery. Each student selects their respective path and how they can become their best selves after four years of graduate education and training. There is an unparalleled feeling of achievement through each small success, ultimately with conferment of the Doctor of Pharmacy Degree and qualification by state and board certification exams.

While pharmacy school does an excellent job of preparing students for post-graduate accomplishments through well-rounded approaches, there are experiences, or learning lessons, that will occur post-graduation. These will likely be in the workplace or a professional organization, potentially related to “soft skills,” self-perception, or other commitments. Might perhaps be within your personal life - everything is interconnected. With any challenge, it is oftentimes best to learn from the experiences of others in advance, particularly those that have more recently encountered the same as well. Continuous self-improvement strategies can set yourself apart from others, both in a professional and personal setting.

Pearls to Make a Great Transition to a New Practitioner Identify Excellent Mentors for Support The ideal mentor will be someone to influence your personal and professional growth. Identify someone that you connect with to provide guidance in the right direction - a person that inspires you to be your best. You likely have had several mentors in pharmacy school, and in particular during a residency/fellowship program. Keep in contact with them. Reach out when you have questions, whether networkingrelated, life advice, or personal interests. These are people truly invested in your success, and not competing with it. Mentors see the talent and ability within you, even if you find it difficult at times to see within yourself.

Get Involved with Organizations One of the best things you can do as a new practitioner is to join a local, state, and/or national professional pharmacy organization. Consider this to be your opportunity to become more involved, make an impact, and network with others. This can distinguish your identity in a professional setting and develop your personal brand. There is also always a learning opportunity by connecting with colleagues and collaborating on a project or process. Stay informed within the pharmacy profession and remember to utilize available resources to facilitate your practice advancement. There are always plenty of prospects for involvement, whether at the committee or leadership level.

Own and Grow from Your Mistakes Everyone, no matter how good, will make mistakes. It is what we do after making a mistake that shows our true character. If you make a clinical mistake - learn from it. Reflect on why you made that mistake, and use it as an experience for growth. Have a bad interaction with a provider? Follow-up with them to clear the air, and try to set things right as you never know who you will need on your side for future projects.

Think ahead and not just in the moment. Accidentally offend a coworker? Own how you misspoke, apologize, and promise them that you will do better.

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TSHP NEW PRACTITIONER CORNER

TJHP Pearls for the New Practitioner Section

Earn Rapport Amongst a Team Earning rapport on the healthcare team is a critical part at any practice site. Some physicians and healthcare team members will take longer than others to build rapport. Find out their preferred method and style of communication, which may vary! Attempt communication through a structured approach, such as Situation, Background, Assessment, and Recommendation (SBAR), or a similar method that keeps your communication clear, organized, and direct. You can use this method in communicating a medication error/identified discrepancy, identification of a patient barrier to care (e.g., medication adherence, financial issues), or a patient hand-off. In addition, do not forget to provide follow-up when needed, or committed. Set yourself apart as someone that is a reliable, motivated, and integral team player.

Perceptions are long-lasting and can influence quite a bit of one’s professional trajectory and career. Use this to your advantage.

Trust in Yourself and Your Abilities It is common for new practitioners to suffer from Imposter Syndrome - doubting their own abilities and feeling like a fraud. This might be related to a fear of under-performance, especially among consistently high performers, or not living up to expectations, potentially in a new practice setting. Recognize the signs and understand the triggers of this phenomenon. Transitioning from student to pharmacist and the shift in responsibilities can be daunting for some. Trust in your training, and know that you can always ask questions. There is a huge network of people available to support you. Most importantly, trust in yourself and be confident; you have earned it.

Manage Workplace Challenges Learn how the current workplace does things and WHY before trying to change things. Nobody appreciates the person that is constantly saying “well, my old place did this.” When trying to change things, do this slowly and tackle the big things first. Earning trust amongst a team is critical, particularly when undertaking a new role in a unit or workplace. Understand the needs of the team and identify what your role will be. Are there small wins or successes you can accomplish? If an electronic medical record order set needs to be developed or refined, recognize the current gaps and integrate these within your plan. Be familiar with the data. And always reach out and discuss approval from key stakeholders prior to formally presenting or going live with an initiative. To ensure success, everyone needs to be on the same page.

Importantly, do not forget to connect with those that would be affected by a new process or system and educate in advance when needed.

Learn How to Say No It is easy to get in the habit of saying yes to every opportunity, presentation, or project, especially when you are just starting out in a new setting and want to make a good impression. Be selective about the extra work you take on so that you can do the work well. The final product will say more than your volunteer efforts. Think about how you can efficiently and successfully fit a new venture into your schedule before involving yourself. Reflect on your bandwidth, because this will impact your performance credibility. Consider your mental health too by not over-committing.

Understand What Gives You Personal Fulfillment Take time to do the things that you enjoy. Remember that you have a life outside of pharmacy and to pursue your interests - work will always be there, but other things in life are fleeting. Live a life without regrets. Take scheduled time off work when you need it – visit your family/friends and go on a vacation. And when in a new workplace/city, connect with others – friendships are important. Personal fulfillment will positively impact both your personal and professional performance.

Make the most of your membership.

Learn more about your membership benefits by reading the TSHP Membership Guide.

Click Here VOLUME 20 | ISSUE 3 | FALL/WINTER 2021 | TJHP

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TSHP PHARMACY STUDENT CORNER

Student Pharmacy Leaders around Texas My name is Rifat Humayra, I am currently a P4 from the University of Houston (UH) College of Pharmacy as well as this year’s TSHP Student Section Executive Committee (SSEC) Chair.

Prior to pursuing my PharmD, I graduated from the University of Texas at Dallas with a Bachelor of Science in biology.

I have always held an active leadership role in SSHP as Secretary and Vice President since entering pharmacy school. Through these roles, I upheld the UH SSHP motto, “we are your residency connection,” by serving as the link between students and residencies in healthsystem pharmacies. I took part in organizing events such as residency workshops and showcases.

As this year’s SSEC Chair, I hope to serve as a bridge between student leaders from SSHP chapters across Texas and TSHP. My mission is to enable all pharmacy students, at every level, to build strong networks that will accelerate their careers. I plan to organize meetings to inform SSHP leaders of the most current services and opportunities available through TSHP. I am excited to work with everyone in SSEC this year and look forward to the things we will accomplish together.

Rifat Humayra, CPhT, PhTR 2021-2022 SECC Chair University of Houston College of Pharmacy, Class of 2022

Hi everyone! My name is Haley Barnes, and I am honored to serve TSHP on the TJHP Editorial Advisory Board. The Pharmacy Student Corner is a special place for students to reflect on their journey as student pharmacists. As your 2021-2022 SSEC Chair, Rifat Humayra, wrote in her Chair’s Note, it’s important that SSHP students have networks to connect with each other during our professional journeys. The Pharmacy Student Corner is one of those networks.

Since the start of the COVID-19 Pandemic in March 2020, Texas student pharmacists have uniquely been affected by the rapid transition in and out of virtual learning. As a testament to our resiliency, I also know that Texas student pharmacists have uniquely stepped up to tackle the challenges of vaccinating our great state, addressing vaccine hesitancy, and relaying critical information about COVID-19 prevention and treatments across social media platforms. I am proud to be one of you.

My number one goal is to ensure Texas student pharmacists have a platform to grow their voices. The Pharmacy Student Corner is a premiere chance to share your story. The Corner can include original student pharmacist research relating to health-system pharmacy, comments on trends in drug use, opinions on public health issues of interest to the hospital pharmacy profession, news from Texas SSHP sections, and more. TSHP Interact also offers a digital platform for you to share your thoughts or the work of student pharmacists in your SSHP section. There are many publication opportunities through TSHP, and I’m thrilled to play a role in your publication journey.

For more information on how to submit to TSHP, please email haleybarnes@my.unthsc.edu.

We are currently accepting submissions to The Pharmacy Student Corner March 2022 issue.

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VOLUME 20 | ISSUE 3 | FALL/WINTER 2021 | TJHP

Haley Barnes, MS, CPhT, PhTR TJHP Editorial Advisory Board, The Pharmacy Student Corner University of North Texas Health Science Center College of Pharmacy, Class of 2024

TSHP PHARMACY STUDENT CORNER

Featured Pharmacy Student Chapter

FEATURED PHARMACY STUDENT CHAPTER

Texas A&M Student Society of Health-System Pharmacists Take a look at what the Texas A&M SSHP has been up to lately: August 2021:

Texas A&M SSHP Executive Committee

August 16th: SSHP first general meeting targeted to obtain new members for the school year.

August 17th: Medication Safety Committee Meeting about introduction to the committee and Dr. Delaney Ivy speaking about medication safety during pregnancy.

August 24th: ADAPT Committee Meeting - Introduction to diabetes and the committee.

August 26th: AAIM Committee Meeting on the COVID vaccines.

August 26th: Twin City Mission service-learning event in College Station hosted by Medication Safety Committee.

August 30th - September 3rd: Hope Pregnancy Center Donation drive. Donation drive set up by Medication safety in conjunction with APhA's Women’s Health Committee on the College Station Campus.

August 31st: SSHP Social - "Speed Meeting" over Zoom led by Social Chair Tori Shiver.

Pictures from August 16th at the SSHP first general meeting September 2021: September 2nd - 9th: SSHP polo fundraiser led by Fundraising Chairs.

September 6th: Second general meeting. SSHP hosted two guest speakers which were former Texas A&M students.

They talked about residency and offered advice for students interest to pursue a PGY-1.

September 9th and 23rd: Twin City Mission service learning event in Bryan, Texas hosted and led by Medication Safety Committee.

September 14th: Advocacy Chair applications released.

August 31st's "Speed Meeting"

September 6th's Second General Meeting Guest Speakers VOLUME 20 | ISSUE 3 | FALL/WINTER 2021 | TJHP

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TSHP PHARMACY STUDENT CORNER

Featured Student Chapter

September 2021 (continued): September 22nd: Ambulatory Care Committee Meeting with an introduction to the committee and overview about Ambulatory Care with Dr. Heather Hay as guest speaker.

Pictures from September 25th at the Kingsville Farmer's Market September 25th: Kingsville Farmers Market SL event hosted by Medication Safety Committee. Kingsville Farmers Market is aimed to serve the underserved of Kleberg county.

September 30th: 2021- 2022 Advocacy Chairs elected.

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VOLUME 20 | ISSUE 3 | FALL/WINTER 2021 | TJHP

TSHP PHARMACY MANAGEMENT SECTION

Section Updates Everything you wanted to know about the TSHP Pharmacy Management Section and more!

What is the TSHP Pharmacy Management Section?

The Pharmacy Management Section is one of five top-level groups responsible for key functions within our organization. The Pharmacy Management Section recommends and coordinates continuing education programs for its members, provides guidance on policy issues involving the section’s area of interest and expertise and other duties as assigned by the TSHP Board of Directors. The Section includes TSHP members who practice in management or supervisory positions and who have common and/or unique interests, goals, or practice settings.

What is the TSHP Pharmacy Management Section doing now?

Our current primary focus is developing themes and content for the 2022 TSHP Annual Seminar next May in Round Rock. While that may seem far away given our current pressing issues, deadlines are fast approaching to ensure necessary lead times are met.Current focus areas for the 2022 seminar include: Employee engagement in challenging times / preventing burnout Addressing the technician shortage Productivity, budgeting and reporting financials Regulatory and compliance changes We hope you find the topics interesting and relevant to your practice and professional development.

What are the other priorities for the TSHP Pharmacy Management Section?

One of the lessons learned from the pandemic was that we cannot solely rely on the annual seminar as a means to achieve our goals.There have been periodic alternative programs beyond the annual seminar in the past. However going forward we will be much more intentional about diversifying our efforts; both from a timing and topic perspective. Examples include: Quarterly webinars on topics such as 503b and employee engagement Training programs including technician medication reconciliation Developing core competencies for pharmacy technicians Peer networking and operational database development

Our team and you We are very blessed to have a large, diverse and very talented current team. We could not function effectively without the great support from Stacey Mather and her TSHP staff. Lastly, we want to acknowledge our past section’s leadership under Wes Wells and our current TSHP president Latresa Billings. The only other thing we might be missing is you! If you have a passion for leadership and pharmacy management please reach out to Eric Bauer at ericbauer@texashealth.org or Stacey Mather at Stacey.Mather@tshp.org if you have any questions.

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When you donate, the sky is the limit for the future of Texas pharmacy.

To donate or to learn more about the Research & Education Foundation, visit www.tshp.org/foundation.

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VOLUME 20 | ISSUE 3 | FALL/WINTER 2021 | TJHP

Identifying, Assessing, and Reporting Human Trafficking in a Healthcare Setting

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Pooja H. Patel, PharmD; Clinical Assistant Professor, Texas A&M University & Clinical Pharmacy Specialist, Ambulatory Care, Memorial Hermann Healthcare System Tzuchen Jou, PharmD; PGY-1 Pharmacy Resident, Memorial Hermann Southwest Hospital Aleesha Ali, PharmD; Pharmacovigilance Specialist at ProPharma Group Address correspondence to: Pooja H. Patel, PharmD Address: Texas A&M Irma Lerma Rangel College of Pharmacy Memorial Hermann Texas Medical Center/Medication Therapy and Wellness Clinic 6414 Fannin St., Suite G100, Houston , TX 77030 E‐mail: phpatel@tamu.edu

Keywords: Human trafficking, role of pharmacists, role of pharmacy technicians

INTRODUCTION Human trafficking is a significant public health issue which has received increased visibility in the past decade, leading to efforts to 1,2 recognize and address it from the international community. It is a form of modern-day slavery which involves the exploitation of men, 3 women, and children into forced labor or sex for profit. On a global scale, it has been estimated to be a $150 Billion a year industry that affects 25 million people, making it the second most profitable crime 4,5 after drug trafficking. A common misconception is that human trafficking only happens in other countries. However, victims have 6,7 been identified in all 50 states and the District of Columbia. While the prevalence of human trafficking victims in the United States is difficult to estimate, the National Human Trafficking Hotline provides one of the most extensive data sets in the country. In 2018, almost 11,000 cases of human trafficking were reported to the National 8 Hotline, and over 23,000 survivors were identified. Texas has ranked second in the nation for the highest number of cases reported by 7 states in the past five years.

Healthcare providers are more likely to encounter potential victims of human trafficking. Patient interactions have been known to be missed opportunities for intervention on their behalf.

Reports show that between 50–88% of survivors had contact with 9,10 healthcare provides while being trafficked. It is important to understand that situations in which trafficked persons seek care often serve as the first and perhaps the only point of contact for them. Reports from survivors indicate that 50-98% of survivors sought health care services in a variety of settings during their time 11 in captivity. As such, healthcare professionals can help potential victims and are well-positioned to do so. To help alleviate the global burden of human trafficking, healthcare workers have been called to 12 serve in a more significant role. Several studies have shown that training healthcare professionals in human trafficking have helped 13-15 increase awareness and recognition of victims. Also, a survey of healthcare workers showed that those who received training were more likely to encounter a victim in their area of practice, report instances of trafficking, and have greater confidence in their ability to identify victims.16 Another survey that also included students concluded that those with training demonstrated improved competency in victim identification.17 Considering the potential impact of healthcare professionals as a "first responder" to human trafficking, increasing awareness and education is imperative.

18,19 Although actions have been taken on a national level, several states are at the forefront of combating this crime and have passed legislation that requires healthcare professionals to complete 20-23 training on human trafficking prevention.

Pharmacists can play a vital role in the fight against human trafficking. As one of the most accessible healthcare professionals available to the public and one that sees patients more frequently 24 than any other provider, pharmacists are in an opportune position to identify and care for potential victims. Public perception also ranks pharmacists among the most highly trusted professionals.

Specific healthcare trends like the growth of retail clinics may 25-27 increase public interface, which further underlines the importance of training for pharmacists and pharmacy technicians.

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Identifying, Assessing, and Reporting Human Trafficking in a Healthcare Setting TYPES OF HUMAN TRAFFICKING What is human trafficking?

To identify potential victims, it is vital first to understand what qualifies as human trafficking under the law and the underlying characteristics between the different types. U.S. law defines the "severe forms of trafficking in persons" as the use of force, fraud, or coercion in the exploitation of a person for labor, services, or commercial sex. An exception occurs in the induction of minors into commercial sex, where the presence of force, fraud, or coercion does 28 not need to be present. The legal definition classifies human trafficking as a multifaceted crime, which can be more easily understood using the Action-Means-Purpose (AMP) Model, outlined in Table 1. Human trafficking occurs when a perpetrator, also referred to as a trafficker, takes action and applies the means of force, fraud, or coercion to a victim to provide commercial sex acts or labor or services. Essentially, the presence of at least one feature from each column may help to determine a potential human trafficking 29 situation. It is essential to realize that eliciting the information to confirm the presence of these elements can be difficult and that an inability to do so should not deter healthcare professionals from further assessment of the potential victim. Common types of sex trafficking may include escort services, pornography, illicit massage businesses, brothels, and outdoor solicitation. Labor trafficking may entail agriculture, domestic work, restaurant and service, and even 30 healthcare.

Who are the victims and the traffickers?

Human trafficking can happen to anyone, and victims can be of any religion, culture, or ethnic group. In addition, they may be of different socioeconomic classes, education levels and may or may not be documented. While demographics of individuals can vary, there are specific populations which are more vulnerable to becoming victimized. Targets include minors in the child welfare system, homeless and runaway youth, foreign nationals and persons with a history of trauma, abuse, substance use, or recent 31 relocation/migration. Traffickers can be individuals or criminal networks. They can include pimps, small businesses, employers of 32 domestic servants, family members, or intimate partners.

Where/when might victims be encountered?

In a healthcare context, victims may seek treatment for physical injuries or abuse, sexually transmitted infections (STIs), pregnancy, infections, dental problems, substance use disorders, or other chronic conditions. Frequently reported treatment sites and providers include hospitals/emergency rooms, Planned Parenthood, primary care physicians, dentists, OB-GYNs, and clinics such as urgent care, 10,33 women's health, and neighborhood clinics. For the pharmacists and

pharmacy technicians in a community setting, an encounter with a 9 potential victim may occur when prescriptions are filled.

INDICATORS OF TRAFFICKING IN A HEALTHCARE SETTING Indicators of human trafficking may be helpful to a healthcare professional to identify potential victims of human trafficking. The indicators listed in this article are not inclusive of all possible signs and the healthcare professional should consider them in the context of the situation. It is also important to note that victims may exhibit some or none of these indicators. However, the recognition of multiple signs may warrant investigation.

Behavioral/situational indicators Traffickers usually exercise extreme degrees of control over the victims and often escort them when they seek care. The accompanying individual may speak or interpret for the victim, refuse 34 to let the patient have privacy, or appear dominating. One study revealed that survivors reported traffickers filling out their paperwork and communicating on their behalf when visiting healthcare facilities.

9 Other indicators may show victims not in possession of their identification documents or money. They may not be able to provide their address or may be unaware of their location, the current date, or time. When asked questions, they may share an inconsistent or rehearsed history or be unwilling to discuss the nature of their injury or illness. Potential victims may also display avoidant or nervous behavior. Specific indicators of sex trafficking include inappropriate clothing for the weather or venue, reporting a high number of sexual partners, and using language familiar to the commercial sex industry.

Children may also display highly sexualized behavior or have a history 34,35 of running away from home.

The AMP Model

Action + Means + Purpose = Human Trafficking

Action Induce Recruits Harbors Transports Provides or Obtains

Means

a

Purpose

Force Fraud or Coercion

Commercial Sex (Sex Trafficking) or Labor/Services (Labor Trafficking)

a

Minors induced into commercial sex are human trafficking victims – regardless if force, fraud, or coercion is present Table 1. Adapted from the National Human Trafficking Hotline

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Identifying, Assessing, and Reporting Human Trafficking in a Healthcare Setting Physical Health Indicators Survivors often describe medical care as being delayed or deprived 9, 36 by traffickers during their time in captivity. This could lead to the presentation of severe infections from untreated conditions such as STIs, urinary tract infections (UTIs), poor dental hygiene, skin infections, or physical trauma. Malnourishment or dehydration may be seen in victims of labor trafficking, in addition to musculoskeletal injuries or illnesses from chemical exposure. Adult survivors of sex trafficking also report frequent reproductive health 10 issues, such as STIs, UTIs, and vaginal discharge. In child sex trafficking, pregnancy or evidence of abortions at a young age, STIs, 35 UTIs, or physical trauma to genitals and/or rectum are indicators.

9 Payment for health services often falls to the victim, which may also contribute to delays in care. As an accessible and free healthcare provider, patients may go to pharmacies for treatment consultations, putting pharmacists and pharmacy technicians in a position to recognize victims.

Mental health indicators The trauma of human trafficking leads to frequent psychological 10 conditions in victims. Commonly reported issues during and after trafficking include depression, anxiety, flashbacks, shame/guilt, post-traumatic stress disorder, and attempted suicides. 34 Victims may also display more severe signs of mental trauma such as affective dysregulation, hostility, or attachment or dissociation disorders. The devastating mental health consequences highlight the need to take a sensitive, culturally competent approach to caring for the patient.

Signs in the pharmacy Pharmacists and pharmacy technicians should be on the lookout for signs of potential trafficking in the pharmacy, especially those in a community setting, where large volumes of patients may be seen in a single day. The prescription history of a potential victim may be lacking or show frequent refill requests due to medications being lost or stolen. Prescription details such as a tendency to come from urgent care clinics or emergency services with various prescribers may also suggest trafficking. 37 Medications indicated for STI treatment or birth control are used frequently or inappropriately, such as at a very young age. 34 Additional indicators include a lack of insurance coverage and paying with cash. 9 Even the nature of retail purchases may reveal a trafficking situation; survivors have reported traffickers bringing them to local pharmacies to get basic supplies and order large quantities of condoms from the pharmacy counter. Others also report multiple purchases of emergency contraception.27 While many of these signs alone may not indicate human trafficking, it is crucial for pharmacists and pharmacy technicians to be aware of potential indicators in their professional context.

ASSESSING POTENTIAL VICTIMS Ensure safety Recognition of the indicators of human trafficking in a patient may lead the healthcare professional to suspect a potential case of trafficking and warrant further assessment. As previously mentioned, gathering information in a healthcare setting may be complicated and it is important to take steps that ensure the patient's safety and build trust. The U.S. Department of Health and Human Services (HHS) offers screening tools and guidance for assessing victims of human trafficking. First, ensure the patient is alone as an accompanying individual may be a trafficker posing as a family member, spouse or employer and his or her presence may prevent victims from 9, 38 communicating with the provider. Pharmacists can utilize the mandated counseling of new prescriptions as an opportunity to speak with the patient alone. In settings with multiple healthcare professions, pharmacists and pharmacy technicians can involve other disciplines in their effort to separate the potential victim from a trafficker. However, in any situation that requires these measures, communicate and act discreetly to not raise suspicion. If interpreters are necessary, they should be appropriately screened to confirm they have no relation to the victim or trafficker and do not have a conflict of interest. Victims can experience fear, shame, and guilt, which may prevent them from disclosing their situation completely or answering 9 questions truthfully. Therefore, gaining the trust of potential victims is important when interacting with them. Some sample messages suggested include "our priority is your safety," "we are here to help you," and "you are entitled to assistance. We can help you get that 39 assistance."

Asking screening questions To determine what and how to ask the patient screening questions, the National Human Trafficking Resource Center (NHTRC) provides a Comprehensive Human Trafficking Assessment Tool with general and 40 specific questions, and a framework for a protocol to use in healthcare 41 settings (Figure 1). Currently, there is no validated tool for pharmacists or healthcare providers to use. However, pharmacyspecific questions that could lead to information about their situation can be easily integrated into a prescription counseling session. For example, asking the patient where they store their medications, how they keep track of them or handle them may illustrate their level of autonomy at home. Questions regarding the visit with the provider that prescribed the medication, how they were told to take it, or what they are taking it for may disclose why they were seeking care. In some instances, victims are unaware that they are being trafficked at 9 all, which may be due to cultural differences from their home country.

As previously emphasized, careful communication during screening is required to navigate the complexities of interacting with a human trafficking victim.42

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Identifying, Assessing, and Reporting Human Trafficking in a Healthcare Setting

Figure 1. Adapted from the National Human Trafficking Hotline

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Identifying, Assessing, and Reporting Human Trafficking in a Healthcare Setting HOW TO REPORT CASES OF HUMAN TRAFFICKING Reporting There are several ways to report suspected human trafficking activity.

In case of an emergency, please call 911. Some non-emergent ways to 43 notify federal law enforcement include: Call the National Human Trafficking Resource Center, a multilingual, toll-free, 24-hour anti-trafficking hotline at 888-3737888.

Call U.S. Immigration and Customs Enforcement (ICE) Homeland Security Investigations (HSI) using the toll-free number at 1-866347-2423 or report online https://www.ice.gov/webform/ice-tipform.

Submit a tip online to the Federal Bureau of Investigations (FBI) at https://tips.fbi.gov/ or call your local FBI field office, list found on https://www.fbi.gov/contact-us/field-offices/field-offices.

CONCLUSION Pharmacists and pharmacy technicians are one of the most accessible healthcare professionals. Pharmacists and pharmacy technicians must recognize the behavioral/situational, physical health, and mental health indicators that may be indicators of human trafficking in a healthcare setting. Thereafter, be able to ensure safety and ask appropriate screening questions to assess potential victims. Lastly, all suspected human trafficking activity should be reported to the appropriate federal law enforcement agency as soon as possible.

DISCLOSURES The authors have no disclosures.

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U.S. Department of State. Trafficking in persons report. June 2019; https://www.state.gov/reports/2019trafficking-in-persons-report/. Accessed March 25, 2020.

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10. Lederer L. The Health Consequences of Sex Trafficking and Their Implications for Identifying Victims in Healthcare Facilities. Annals Health L. 2014;23:61.

11. Armstrong S, Greenbaum VJ. Using Survivors' Voices to Guide the Identification and Care of Trafficked Persons by U.S. Health Care Professionals: A Systematic Review. Adv Emerg Nurs J. 2019;41(3):244260.

12. CdeBaca L, Sigmon JN. Combating trafficking in persons: a call to action for global health professionals.

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14. Grace AM, Lippert S, Collins K, et al. Educating health care professionals on human trafficking. Pediatr Emerg Care. 2014;30(12):856-861.

15. Egyud A, Stephens K, Swanson-Bierman B, DiCuccio M, Whiteman K. Implementation of Human Trafficking Education and Treatment Algorithm in the Emergency Department. J Emerg Nurs. 2017;43(6):526531.

16. Beck ME, Lineer MM, Melzer-Lange M, Simpson P, Nugent M, Rabbitt A. Medical providers' understanding of sex trafficking and their experience with at-risk patients. Pediatrics. 2015;135(4):e895-902.

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Sinha R, Tashakor E, Pinto C. Identifying Victims of Human Trafficking in Central Pennsylvania: A Survey of Health-Care Professionals and Students. Journal of Human Trafficking. 2018;5:1-11.

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U.S. Department of Health and Human Services Office on Trafficking in Persons. SOAR to health and wellness training. 2017; https://www.acf.hhs.gov/otip/training/soar-to-healthand-wellness-training. Accessed March 25, 2020.

19. U.S. Department of Justice. Coordination, Collaboration, Capacity: Federal Strategic Action Plan on Services for Victims of Human Trafficking in the United States, 2013–2017. 2014; https://www.ovc.gov/pubs/FederalHumanTraffickingS trategicPlan.pdf. Accessed March 25, 2020.

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U.S. Department of Justice. Human Trafficking.

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30. Polaris. The typology of modern slavery: defining sex and labor trafficking in the United States. March 1 2017.

31. National Human Trafficking Hotline. The victims. https://humantraffickinghotline.org/what-humantrafficking/human-trafficking/victims. Accessed March 25, 2020.

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National Human Trafficking Hotline. The traffickers. https://humantraffickinghotline.org/whathuman-trafficking/human-trafficking/traffickers.

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Chisolm-Straker M, Baldwin S, Gaigbe-Togbe B, Ndukwe N, Johnson PN, Richardson LD. Health Care and Human Trafficking: We are Seeing the Unseen. J Health Care Poor Underserved. 2016;27(3):1220-1233.

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Turner-Moss E, Zimmerman C, Howard LM, Oram S. Labour exploitation and health: a case series of men and women seeking post-trafficking services. J Immigr Minor Health. 2014;16(3):473-480.

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Resources: screening tool for victims of human trafficking https://www.acf.hhs.gov/sites/default/files/orr/screeni ng_questions_to_assess_whether_a_person_is_a_traffic king_victim.pdf. Accessed March 25, 2020.

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2011; https://humantraffickinghotline.org/resources/compre hensive-human-trafficking-assessment-tool. Accessed March 25, 2020.

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OVC TTAC. https://www.ovcttac.gov/taskforceguide/eguide/.

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THERAPY UPDATE

Retrospective Evaluation of the Safety of Remdesivir Use in Non-Critically Ill Patients with COVID-19 and Renal Dysfunction (REM-RENAL) 10

Lakshmi Pillai, PharmD; Clinical Staff Pharmacist at Memorial Hermann TMC Vida Haddad, PharmD, BCPS, BCCCP; ICU Pharmacist at Baptist Saint Anthony Health-System Ronald Hall, PharmD, MSCS; Head of the Clinical & Translational Science Division, and the Director of the Dose Optimization and Outcomes Research Program at Texas Tech University Health Sciences Center's Jerry H. Hodge School of Pharmacy Jamie McCarrell, PharmD, BCGP, BCPS; Director of Pharmacy at Baptist Saint Anthony Hospital Maegan Whitworth, PharmD, BCPS; Assistant Professor in the Adult Medicine Division in the Department of Pharmacy Practice at Texas Tech University Health Sciences Center's Jerry H. Hodge School of Pharmacy Address correspondence to:

ABSTRACT Purpose Remdesivir, an FDA-approved medication for the treatment of COVID-19 infection, has a recommendation against use in patients with an estimated glomerular filtration rate (eGFR) less than 30 mL/min. Although not contraindicated, limited evidence exists for the safety of remdesivir use in patients with renal dysfunction. The purpose of this study was to provide guidance for further use of remdesivir in patients with baseline renal dysfunction.

Methods This is a single-center retrospective study conducted on non-intensive care unit patients with a documented diagnosis of COVID-19 and either acute kidney injury (AKI) or chronic kidney disease (CKD). Patients were separated into two treatment arms based on whether they received remdesivir or standard of care (SOC). The primary outcome was occurrence of AKI between patients receiving remdesivir versus patients receiving SOC. Secondary outcomes included rate of recovery and supplemental oxygen requirements.

Lakshmi Pillai, PharmD Address: 2218 Ansbury Dr. Houston, TX 77018 E‐mail: lakshmipillai1006@gmail.com

Keywords: Remdesivir, COVID-19, acute kidney injury, renal dysfunction

Results At 48 hours, a higher incidence of AKI was seen in the SOC arm compared to the remdesivir treated arm (16.7% vs 5.8%; P=0.010) with no significant difference seen between groups regarding change in oxygenation status (P=0.996). However, the average days to discharge was increased in the remdesivir arm compared to the SOC arm (10.2 vs. 6.5; P=0.001).

Conclusion The use of remdesivir was not seen to promote AKI in patients with baseline renal dysfunction.

However, it was associated with an increased hospital length of stay when compared to the SOC.

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THERAPY UPDATE

Retrospective Evaluation of the Safety of Remdesivir Use in Non-Critically Ill Patients with COVID-19 and Renal Dysfunction (REM-RENAL)

BACKGROUND SARS-CoV-2, otherwise known as coronavirus or COVID-19, is a severe acute respiratory syndrome which created the ongoing pandemic beginning late 2019. Symptoms range from mild disease to severe respiratory illness hospitalization. Remdesivir, initially developed during the Ebola Epidemic in 2013, is an1 adenosine nucleotide prodrug that inhibits viral RNA replication. The medication first received emergency use authorization (EUA) on May 1, 2020 for the management of patients with COVID-19. On October 22, 2020 it received FDA approval for the treatment of COVID-19 in adults and pediatric patients at least 12 years of age with a minimum weight of 2 40 kg. Prior to approval, Beigel, et al. published a randomized controlled trial, known as the ACTT-1 trial, analyzing the use of remdesivir in adult patients hospitalized with COVID-19. Preliminary data showed that remdesivir was superior to placebo in shortening 3 the time to recovery. Conversely, the SOLIDARITY trial, conducted by the World Health Organization (WHO), found no mortality benefit and little to no effect on initiation of ventilation or duration of 4 hospital stay in hospitalized patients administered remdesivir.

Neither of these trials, however, studied the use of remdesivir in patients with an eGFR less than 30 mL/min. Remdesivir is formulated with the excipient sulfobutylether-beta-cyclodextrin (SBECD) which 5 can accumulate in patients with renal dysfunction. Therefore, due to the lack of evaluation in this population, the remdesivir package labeling recommends against the administration of remdesivir in 2-4 patients with an eGFR less than 30 mL/min. This guidance was not listed as a contraindication, but rather a recommendation against the use of remdesivir for this specific population. As data is limited on the safety of remdesivir use in patients with baseline renal dysfunction, the purpose of this study was to analyze the benefit-risk profile of remdesivir use within this specific population and provide a pilot analysis for quality improvement purposes at an institutional level.

METHODS Study Design This was a retrospective study conducted between May 22, 2020 and December 31, 2020 at a single institution in Amarillo, Texas. Adult patients with a documented diagnosis of COVID-19 with either acute kidney injury (AKI), acute renal disease, or chronic kidney disease (CKD) stage 3AB-5 were included in this study. Patients admitted to critical care units, pediatric patients (<18 years of age) and patients on dialysis were excluded. Patients meeting inclusion criteria were broken down into one of two treatment arms; remdesivir treated or standard of care (SOC). Remdesivir intravenous infusion therapy was as follows: 200mg on day one followed by 100mg daily for five to ten days with duration of therapy being decided by the provider and patient clinical status. The SOC arm consisted of variable therapies,

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such as, over the counter supplements, antibiotics, dexamethasone, among others and were based on physician preference. Patients within the remdesivir arm were not restricted from receiving agents considered as SOC. We hypothesized that remdesivir would be safe for use in patients with baseline renal dysfunction. Informed consent was not needed as patient recruitment was not required. This study was approved by The Texas Tech University Health Sciences Center at Amarillo Institutional Review Board and a waiver of informed consent was received prior to data collection due to the retrospective nature of this research.

Data Collection Our institution’s electronic medical record, EPIC, was utilized for patient chart review and to obtain data points required for assessment of each study objective. Demographic data and baseline characteristics collected include patient’s age, gender, race, ethnic group, and renal diagnosis on admission. Date of admission and date of discharge or mortality were recorded to measure time to discharge or time to mortality. Discharge status was also documented to track location of discharge versus mortality. Clinical data points collected included serum creatinine on admission or prior to initiation of COVID-19 treatment, serum creatinine at 48 hours and seven days after initiation of COVID-19 treatment, administration of remdesivir, length of remdesivir therapy if administered, oxygen requirements prior to initiation of COVID-19 treatment, and oxygen requirements after five and ten days of COVID-19 treatment initiation.

Outcomes The primary endpoint in relation to safety outcomes was to identify if remdesivir was associated with a clear change in serum creatinine (SCr) or AKI defined by the 2012 Kidney Disease: Improving Global Outcomes (KDIGO) guidelines as either an increase in SCr ≥0.3 mg/dL within 48 hours or an increase in SCr ≥1.5 times baseline value within the prior seven days. The secondary endpoints, in relation to clinical outcomes, were rate of recovery measured as time to discharge or time to mortality and changes in supplemental oxygen requirements which was documented as an increase, decrease or no change in needs of supplemental oxygen from time of COVID-19 treatment initiation compared to five days and ten days after COVID-19 treatment initiation.

Statistical Analysis Data was analyzed using STATA® Statistics/Data Analysis version 15.1 (StataCorp LLC, College Station, TX). A univariable analysis was utilized to determine if remdesivir promoted worsening renal dysfunction. A two-sample Wilcoxon rank-sum (Mann-Whitney U) test was utilized to analyze continuous variables including changes in serum creatinine, time to discharge or mortality, changes in oxygenation status, and differences in age groups between treatment arms which are presented as mean values with standard deviation (SD) or median values with an interquartile range (IQR).

THERAPY UPDATE

Retrospective Evaluation of the Safety of Remdesivir Use in Non-Critically Ill Patients with COVID-19 and Renal Dysfunction (REM-RENAL)

Fisher’s exact test or Chi-square analysis were utilized to analyze nominal data. Statistical significance was defined as a P-value <0.05.

RESULTS Patient Characteristics A total of 433 patients were screened between May 22, 2020 and December 31, 2020. Of these, 217 patients were excluded due to various reasons (Figure 1). The primary indication for exclusion was a diagnosis of end stage renal disease (ESRD) on hemodialysis (34%, n=74). Of the 216 patients meeting eligibility criteria, 120 patients (55.5%) received remdesivir and 96 patients (44.4%) received SOC. Baseline characteristics were relatively similar between the two treatment arms (Table 1). Majority of the population included in both arms were between 70-80 years of age, white, not Hispanic, Latino, or of Spanish origin and had chronic kidney disease stage 3AB-5 as the renal diagnosis on admission. Significant differences were seen among sex between the two treatment arms with more females (60.4%) in the SOC arm and more males (53.3%) in the remdesivir arm (P=0.044). Mean eGFR on admission was 48.97 mL/min [10-101] in the remdesivir arm and 37.11 mL/min [20-52] in the SOC arm.

Primary Outcome When comparing the median serum creatinine at initiation, 48 hours, and seven days of COVID-19 treatment, a significant difference was seen between the treatment arms (Figure 2). At initiation, the median serum creatinine in the remdesivir and SOC arm were 1.26 mg/dL [1.02-1.60] and 1.75 mg/dL [1.24-2.71], respectively (P<0.001). By seven days of treatment, a decline was seen in serum creatinine in both the remdesivir and SOC arms, 1.02 mg/dL [0.81-1.29] and 1.25 mg/dL [0.93-1.85] respectively, however, still with a significant difference between the arms (P=0.0024). The occurrence of AKI, per the KDIGO guideline criteria, at 48 hours was higher in the SOC arm when compared to the remdesivir arm (16.7% vs. 5.8%; P=0.010).

Secondary Outcomes The average time to discharge in the remdesivir and SOC arms were 10.2±8.53 and 6.5±5.42 days, respectively (P=0.001) with a median time to discharge of 7.5 [5-13.5] and 5 [3-8] days, respectively (Figure 3). The average time to mortality in the remdesivir and SOC arms were 15.1±7.48 and 7.26±6.81 days (P=0.003) with an overall occurrence of mortality being 25% (n=30) and 19.8% (n=19), respectively (P=0.364). Lastly, no significant difference was seen between treatment arms in terms of changes in oxygenation status (P=0.996).

DISCUSSION Currently, the only FDA approved agent for treatment of COVID-19 is remdesivir. Often those presenting with critical illness, such as COVID

19, may also present with a degree of renal dysfunction. However, very few studies have evaluated the use of remdesivir in patients with renal impairment. The largest clinical trials to date evaluating remdesivir for treatment of COVID-19 excluded patients with an eGFR <30 2 mL/min/1.73m or requiring dialysis. Because remdesivir package labeling did not restrict use in this population, our institution administered remdesivir to select patients with extreme caution.

Pharmacists monitored renal function daily for those receiving remdesivir and MedWatch forms were filled out for those identified with significant impairment presumed to be directly related to the administration of remdesivir. The question remained whether remdesivir was considered safe for use in patients with baseline renal dysfunction.

In evaluating our primary endpoint, to identify whether remdesivir was associated with AKI, we found that regardless of treatment received, kidney function improved. As a method to standardize and identify if remdesivir was associated with worsening renal dysfunction, we adopted the KDIGO guideline definition of AKI. Per the KDIGO guidelines, criteria for defining AKI includes an increase in serum creatinine ≥0.3 mg/dL within 48 hours. Our data identified that this occurrence was greater in the SOC group compared to the remdesivir group. Due to scarcity of data, remdesivir was likely withheld from administration in patients presenting with severe renal impairment or severely elevated serum creatinine, as identified by the higher median serum creatinine values in the SOC arm compared to the remdesivir arm. A significant difference in SCr was identified between the treatment arms at initiation, 48 hours, and seven days of COVID-19 treatment with the SOC arm having a higher median serum creatinine at all three identified points. With any acute or critical illness, it is common to see an initial decline in kidney function followed by improvement as one recovers. This is consistent with the serum creatinine trend identified through our data.

Secondary outcomes of this study identified that the average time to discharge and mortality were higher in the remdesivir arm compared to the SOC arm. This may be secondary to remdesivir being used as a last effort for mortality prevention in patients presenting with severe illness secondary to COVID-19 regardless of baseline renal function. It is to be noted that recent studies have shown that men with COVID-19 carry a higher risk for worse outcomes and mortality when compared to women. Therefore, it is a possibility that this newfound data may have played a role in our mortality outcomes as 6 there were significantly more men identified than women within the remdesivir arm. In addition, there is a general inclination by physicians to finish the course of remdesivir once started. Therefore, regardless of overall improvement and the ability to be discharged safely home, length of stay was prolonged to complete remdesivir therapy. Looking from a cost-savings standpoint, the average cost of hospital stay per day in Texas per the 2016 American Hospital

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Retrospective Evaluation of the Safety of Remdesivir Use in Non-Critically Ill Patients with COVID-19 and Renal Dysfunction (REM-RENAL)

Table 1. Baseline Characteristics

Figure 1. Study Flow Chart

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Retrospective Evaluation of the Safety of Remdesivir Use in Non-Critically Ill Patients with COVID-19 and Renal Dysfunction (REM-RENAL)

Figure 2. Serum Creatinine at Initiation, 48 hours, and 7 days of Covid-19 Treatment

Figure 3. Overall Time to Discharge

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Retrospective Evaluation of the Safety of Remdesivir Use in Non-Critically Ill Patients with COVID-19 and Renal Dysfunction (REM-RENAL)

Association Annual Survey was $2,578 for nonprofit hospitals, $1,8737 at for-profit hospitals and $2,427 at state/local government hospitals.

For results showing no significant differences between the treatment arms for overall mortality benefit, the extra days of hospital stay associated with remdesivir may be negligible. In addition, FDA guidance does not support continuing outpatient treatment with remdesivir in patients deemed medically ready for discharge. Trial data has shown no additional benefit and low readmission rates in those ready to discharge prior to completion of their scheduled 8 duration of remdesivir therapy. Moreover, because COVID-19 is a novel pandemic, the SOC treatments varied based on physician preference and availability of data at the time of admission. Typical agents seen within the SOC arm consisted of a cocktail of medications, such as, dexamethasone, vitamin C, vitamin D, albuterol, antibiotics, and others that can be administered orally and completed in an outpatient setting.

Reviewing the molecular structure of remdesivir, it may elucidate why its use was not recommended in patients with eGFR less than 30 mL/min. Remdesivir is formulated with the excipient sulfobutyletherbeta-cyclodextrin (SBECD). SBECD is a large, cyclic oligosaccharide that is predominantly renally excreted with a half-life elimination rate 9 of less than two hours in patients with normal kidney function. When accumulated, SBECD has shown to cause mild toxicity to the liver and kidney in rat studies at the maximum dose of 3000 mg/kg which is about 50-fold greater than the amount of SBECD that is typically administered in humans. Studies completed in dogs have shown no histopathological evidence of toxicity with doses up to 1500 mg/kg of 10 SBECD. Voriconazole, an FDA approved antifungal agent, serves as a point of reference as it contains the same SBECD excipient. Dosed twice a day, each 200mg of voriconazole contains 3.2 g of SBECD yielding a total daily dose of 6.4 g of SBECD. 11 Human studies with voriconazole have shown renal dysfunction with the accumulation of SBECD at doses of SBECD greater than 6.4 g per day.12When compared to remdesivir, each 100 mg of the remdesivir lyophilized powder contains 3 g of SBECD and each 100 mg of the remdesivir solution contains 6 g of SBECD.13 Extrapolating the data from studies completed utilizing voriconazole, the total daily dose of SBECD with remdesivir does not exceed the point of expected renal dysfunction of 6.4 g per day. For an expected five to ten day course of remdesivir treatment, the total SBECD administered to a patient is well below the maximum recommended daily dose of 250 mg/kg/day of SBECD from a safety threshold standpoint.2,9,11-12 This study had several limitations due to the retrospective nature of the study. A convenience sample was utilized and variables such as obesity and receipt of concomitant nephrotoxins were not accounted for due to feasibility of analysis. In addition, we did not assess baseline COVID-19 disease severity differences between groups or identify differences in stage and severity of renal dysfunction.

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Critically ill patients were excluded from the study due to multiple confounding factors associated with patients within this class of disease severity, such as, administration of continuous renal replacement therapy vasopressor agents and other concomitant nephrotoxins. Lastly treatment bias was a confounding factor as patients eligible for remdesivir treatment was based on physician preference, as were the agents selected in the SOC group. However, this study was able to include and analyze a relatively large population for a pilot study.

Possibilities for future direction may include an analysis on the effects of remdesivir use on liver function tests in patients with renal dysfunction as this outcome was not collected or assessed within this study.

CONCLUSION From a safety perspective, this study showed that remdesivir did not promote AKI in non-critically ill patients as no clear statistically significant association was identified between the utilization of remdesivir and AKI in those already presenting with baseline renal dysfunction. From an outcomes standpoint, remdesivir was associated with an increased hospital length of stay.

KEY POINTS Remdesivir was not shown to promote acute kidney injury in those with COVID-19 presenting with baseline renal dysfunction.

Remdesivir may be safe for use in patients presenting with baseline renal dysfunction defined as an eGFR <30 mL/min.

Remdesivir was shown to be associated with an increased hospital length of stay likely due to the length of remdesivir therapy. However, it showed no significant differences in mortality outcomes.

DISCLOSURES The authors have no disclosures.

REFERENCES 1. Brown AJ, Won JJ, Graham RL, Dinnon KH, Sims AC, Feng JY, Sheahan TP. Broad spectrum antiviral remdesivir inhibits human endemic and zoonotic deltacoronaviruses with a highly divergent RNA dependent RNA polymerase.

Antiviral Res. 2019;169:104541. doi:10.1016/j.antiviral.2019.104541.

2. VEKLURY® (remdesivir) [package insert]. Forester City, CA: Gilead Sciences, Inc.; 2020.

3. Beigel JH, Tomashek KM, Dodd LE, Mehta AK, Zingman BS, Kalil AC, Hohmann E, Chu HY, Luetkemeyer A, Kline S, Lopez de Castilla D, Finberg RW, Dierberg K, Tapson V, Hsieh L, Patterson TF, Paredes R, Sweeney DA, Short WR, Touloumi G, ACTT-1 Study Group Members. Remdesivir for the Treatment of Covid-19 - Final Report. N Engl J Med. 2020;383(19):1813-1826.

Retrospective Evaluation of the Safety of Remdesivir Use in Non-Critically Ill Patients with COVID-19 and Renal Dysfunction (REM-RENAL)

THERAPY UPDATE

REFERENCES (CONTINUED) 4. WHO Solidarity Trial Consortium, Pan H, Peto R, Henao-Restrepo AM, Preziosi MP, Sathiyamoorthy V, Abdool Karim Q, Alejandria MM, Hernández García C, Kieny MP, Malekzadeh R, Murthy S, Reddy KS, Roses Periago M, Abi Hanna P, Ader F, Al-Bader AM, Alhasawi A, Allum E, Alotaibi A, Swaminathan S. Repurposed Antiviral Drugs for Covid-19 Interim WHO Solidarity Trial Results. N Engl J Med. 2021;384(6):497-511. Advance online publication. https://doi.org/10.1056/NEJMoa2023184.

5. Frequently Asked Questions for Veklury (remdesivir). (2021, February 4). Retrieved from https://www.fda.gov/media/137574/download.

6. Jin JM, Bai P, He W, Wu F, Liu XF, Han DM, Liu S, Yang JK (2020). Gender Differences in Patients With COVID-19: Focus on Severity and Mortality. Front Public Health. 2020;8:152. https://doi.org/10.3389/fpubh.2020.00152.

7. Ellison A (n.d.). Average hospital expenses per inpatient day across 50 states. Retrieved from https://www.beckershospitalreview.com/finance/average-hospital-expenses-perinpatient-day-across-50-states.html.

8. Center for Drug Evaluation and Research. (n.d.). FDAs approval of Veklury (remdesivir) for the treatment of COVID-19. Retrieved from https://www.fda.gov/drugs/drug-safetyand-availability/fdas-approval-veklury-remdesivir-treatment-covid-19-science-safety-and-effectiveness.

9. Adamsick ML, Gandhi RG, Bidell MR, Elshaboury RH, Bhattacharyya RP, Kim AY, Nigwekar S, Rhee EP, Sise ME. Remdesivir in Patients with Acute or Chronic Kidney Disease and COVID-19. J Am Soc Nephrol. 2020;31(7):1384-1386. https://doi.org/10.1681/ASN.2020050589.

10. Luke DR, Tomaszewski K, Damle B, Schlamm HT. Review of the basic and clinical pharmacology of sulfobutylether-beta-cyclodextrin (SBECD). J Pharm Sci. 2010;99(8):3291-3301. https://doi.org/10.1002/jps.22109.

11. VFEND® (voriconazole) [package insert]. New York City, NY: Roerig Division of Pfizer, Inc.; 2002.

12. Yasu T, Konuma T, Kuroda S, Takahashi S, Tojo A. Effect of Cumulative Intravenous Voriconazole Dose on Renal Function in Hematological Patients. Antimicrob Agents Chemother.

2018;62(9):e00507-18. https://doi.org/10.1128/AAC.00507-18.

13. Khwaja A. KDIGO Clinical Practice Guidelines for Acute Kidney Injury. Nephron Clin Pract. 2012;120(4):c179-84.. doi:10.1159/000339789.

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