TJHP - Volume 20 Issue 2 by TSHP

Advancing Pharmacy Practice and Education in Texas

VOLUME 20 | ISSUE 2 | SUMMER 2021

Texas Prescription Drug Monitoring Program Evolution and Outcomes Robert Hutchison, PharmD, BCACP Megan G. Holloway, JD Joseph Carhart, PhD Krista Whalen, PhD

Retrospective Review of Pharmaceutical Care Services Provided by Academic Pharmacy Teams in an Inpatient Setting Sydney N. Kutter, PharmD, BCPS Sebastian Perez, PharmD, BCPS Charlotte Farris, PharmD, BCPS Kutter Delaney Ivy, PharmD, MSc, BCPS, CDE

Do Not Crush List

Optimizing the Timing of Phenytoin Levels in the Inpatient Setting Zhou Fang, PharmD Fang Kaitlin N. Highsmith, PharmD, BCOP Brian M. Dee, PharmD, BCCCP, BCNSP, FCCM

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 President-Elect Designee Rodney Cox, RPh, MS

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

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 Editor Todd Canada, PharmD TJHP Managing Editor Paige Haines

TJHP Editorial Advisory Board:

Questions/Comments journal@tshp.org

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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

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.

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

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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

22 28 33 5

A Message from the TSHP President Latresa Billings, PharmD, BCPS

8 In Memoriam: Sidney Phillips

Local Chapter News

2021 TSHP Member Recognition Awards

2021-2022 Educational Program Preview

87th Legislative Session Report

TSHP 2021-2026 Strategic Plan

22 Texas Prescription Drug

Monitoring Program Evolution and Outcomes

Robert Hutchison, PharmD, BCACP; Megan G. Holloway, JD; Joseph Carhart, PhD; Krista Whalen, PhD

28 Retrospective Review of

Pharmaceutical Care Services Provided by Academic Pharmacy Teams in an Inpatient Setting Sydney N. Kutter, PharmD, BCPS; Sebastian Perez, PharmD, BCPS; Charlotte Farris, PharmD, BCPS; Delaney Ivy, PharmD, MSc, BCPS, CDE

33 Optimizing the Timing of Phenytoin Levels in the Inpatient Setting

Zhou Fang, PharmD; Kaitlin N. Highsmith, PharmD, BCOP; Brian M. Dee, PharmD, BCCCP, BCNSP, FCCM

38 TSHP Research & Education

Foundation Poster Competition 2021 Winners

43 Abbreviated New Drug Application (ANDA) Approvals

45 Do Not Crush List

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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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A MESSAGE FROM THE TSHP PRESIDENT Dear Members and Colleagues, As I enter this year as President of the Texas Society of Health-System Pharmacists (TSHP), I am honored to serve in this season. Without question, the past year has presented numerous unprecedented and difficult challenges. I recognize that our professional engagement at large has never been more relevant and important for those providing pharmacy services in Texas and across the nation. Through transitions and pivoting moments, TSHP membership engagement has continued to provide an abundance of opportunities to learn, teach, mentor, lead and share top quality professional engagement to address various platforms of healthcare even in the midst of a pandemic. Innovative pharmacy practice pathways created to serve during the COVID-19 pandemic have shown us that our pharmacy profession holds a special place at the heart of healthcare, and we have a unique responsibility to lead. During these unprecedented times, many TSHP members and our TSHP staff have demonstrated the ability to advocate for the profession, brainstorm to foster innovative process developments, give back to our communities, and network among many friends and colleagues within our institutions, across our country and the world, despite the challenges before us. The changes around us, whether social, political, technological, scientific, economic, or otherwise, require that we support each other to navigate through new and increasingly complex landscapes, which profoundly impact our work, our communities, and the pharmacy profession at large. In many instances, we have the challenges and responsibility to help shape the new landscapes of pharmacy practice with the inclusion of the illustrated value of pharmacists to health systems and the community as recognized providers. Our TSHP community of pharmacy professionals, including all our pharmacists, technicians, residents, students, and industry sponsors, are integral participants within networks increasing reliance upon the pharmacy workforce for facing the new obstacles which lie ahead for total healthcare provisions. I'm proud of our past TSHP successes over the prior years, particularly in providing more opportunities for meaningful engagement of our members and sponsors, introducing innovative virtual programming formats and topics, supporting advocacy initiatives leading to practice changes, and providing professional development and outreach opportunities. n the future, we will lean on the newly formed TSHP strategic initiatives fashioned to guide our priorities over the next 5 years to ensure we are working towards goals of the organization.

During my term, I will devote myself to fulfill the following ongoing TSHP commitments: To expand the TSHP membership to include a more diverse population among various areas of pharmacy practice and all member categories; To foster the delivery of quality pharmacy education strengthened through academia enriched platforms and related specialty seminars; To cultivate advanced practice initiatives through clinical practice, innovative operations, and leadership assessments and mentorship;

To seek to identify potentials solutions to address healthcare disparities among our communities; To support the expansion of the revitalized Texas Journal of Health-System Pharmacists (TJHP) with extension to three publications per year; To support stabilization of TSHP financial status To assist the TSHP R&E Foundation in sustaining its scholarship, education, and research initiatives.

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A MESSAGE FROM THE TSHP PRESIDENT (Cont'd from Page 5)

Of course, working together with the TSHP members, members of the Executive Committee, and Board of Directors is essential to ensure that TSHP levels its foundation on a sustainable journey promoting the advancement of pharmacy education, clinical practice, professional development, and service provisions among all facets of our pharmacy workforce. Thank you to all of our members for your continued participation and enthusiasm in our professional community. Special recognition and appreciation to our TSHP Board of Directors and the amazing teams of committed volunteers serving on the newly expanded hosts of committees, councils, sections, and taskforces instituted over the former year encompassing pharmacists, technicians, students, and industry leaders. Thank you to our sponsors for your provision of support and service to continually bridge gaps among resources and supplies available to the practitioners across our state, for which many are within our member-driven organization. Through several changing landscapes of schedules and events, our TSHP staff led by Stacey Mather, the TSHP Executive Director, have provided tireless efforts on behalf of the TSHP to sustain pathways to success for the organization through all of the resources, guidance, and support they provide each and every day. Likewise, as for their time and talents also used to support the TSHP R&E Foundation, the TSHP staff continually helps to facilitate the assessments and distributions of the annual scholarships and research awards to new and emerging pharmacy practitioners and various levels of researchers. For these named efforts and so many more, thank you all for the continued commitment to service through TSHP participation and engagement. To this point, we welcome new candidates to join our efforts through TSHP membership and to become engaged to receive member benefits from this organization as well as having an open platform for giving back to the pharmacy profession. The member benefits of joining TSHP cannot be overstated, and we are seeking to provide additional tools and add new networking opportunities to our list of events and resources over the next year. If you are interested in volunteering or have any questions or comments, please reach out to our TSHP Executive Director, Stacey Mather, at stacey.mather@tshp.org or myself as the TSHP President, Latresa Billings at latty142002@yahoo.com. Wishing you all well and looking forward to the horizons that lie ahead for this 2021-2022 leadership year.

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

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Become a donor.

Become a hero. 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. VOLUME 20

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MEMBER UPDATE

IN MEMORIAM: SIDNEY PHILLIPS It is with profound sadness that we report that a beloved member of the TSHP family, and Past President, Sidney Phillips, PharmD, MBA, passed away on Friday, July 2, 2021, at the age of 46 as the single victim of a tragic accident. Sid was a wonderful friend, pharmacist, father, husband, colleague, leader, and mentor. While he could be a bit of a "serious" comedian at times, Sid was an intellectual pharmacist who was willing to share his visions for practice. This loss leaves us all in shock and filled with so much sadness. Sid leaves behind a legacy of advancing the profession of pharmacy through advocacy, dedication to servant leadership, and determination to improve patient care. Sid was born in Lubbock, Texas, and was the valedictorian of his Jayton High School graduating class. He went on the attend Texas Tech University, where he would meet his wife Cheri. He initially majored in petroleum engineering, but ultimately found a passion for medicine and graduating as a doctor of pharmacy. Though a skilled clinician, Sid’s leadership abilities were apparent and led him to earn his MBA from Jack Welch Management Institute. Sid's pharmacy career began as a pharmacy practice resident in 2001 at St. Luke’s Episcopal Hospital in Houston. He then went on to complete a PGY2 management residency with Cardinal Health Clinical Services and Consulting in Houston. His first position out of residency was the Director of Pharmacy for Odessa Regional Hospital in Odessa, Texas. In 2004, Sid transitioned to Trinity Medical Center in Carrollton, where he began his service as Director of Pharmacy before gaining additional responsibility as their Director of Respiratory Therapy and Cardiopulmonary Services. In 2006, Sid took a new role, first as an operations director and then as a regional director of pharmacy practice, with Cardinal Health. During his time with Cardinal, Sid also served for many years as a clinical staff pharmacist on weekends at North Texas Community Hospital to maintain his clinical skills and knowledge. Sid’s time with Cardinal exposed him to the many different needs and issues of health-system pharmacy around Texas. In 2012, Sid became the Director of Pharmacy at Baylor Medical Center at Carrollton and would soon take a larger leadership role as the North Texas Division Director of Pharmacy with Baylor Scott and White Health, overseeing 12 North Texas hospital pharmacies. At the time of his death, Sid was serving as the Administrative Director of Pharmacy for the Memorial Hermann Texas Medical Center Campus. Though at the organization for less than three years, he was considered an essential leader, and his presence during the Covid Pandemic was mentioned often. He oversaw the first shipments of the Covid Vaccine in

Houston. He worked tirelessly to operationalize the vaccine clinic at the hospital and supported several other clinics facilitating over 36,000 vaccinations. Due to this work, Memorial Hermann Texas Medical Center named the vaccine clinic after him.

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MEMBER UPDATE

IN MEMORIAM: SIDNEY PHILLIPS Sid’s work with TSHP began as a student leader at Texas Tech and the Student Section. Over his 20 year career, he served in many positions within Metroplex Society of Health-System Pharmacists and the TSHP Board of Directors from Council Chair to President in 2016. He served an extended term as Immediate Past President due to the untimely death of another pharmacy leader, Rich Cadle. His opinions were well regarded, and he could always bring a laugh to meetings. He was an active supporter of the Political Action Committee and regularly attended Texas State Board of Pharmacy meetings. He was also famous for serving as “security” during the annual seminar reverse expo, his way of supporting industry partners and fellow pharmacy directors. His family would always describe Sid as a farming pharmacist as he had a love of ranching and the land. His time not spent in a hospital was spent with his family working their property or shopping auctions for equipment. Sid is survived by his best friend and wife of 22 years, Cheri; his son, Jude (12) and daughter Johanna (10); his mother Florene; his sister Christy Jo; and countless extended family, friends, and colleagues. He was preceded in death by his father, Joe Bill Phillips. The family has set up a trust for Sid's children's future education expenses. Donations to the children's trust can be made one of two ways: C/O Phillips Family Trust P.O. Box 2153 Houston, TX 77070-9998 Or via Zelle to jjphillipstrust@yahoo.com. The family has also asked that a scholarship fund be established to honor his contributions and legacy in pharmacy practice. Donations to the scholarship fund may be made via the TSHP website. So many of us have wonderful memories of our moments shared with Sid. His being and contributions to pharmacy were beacons of light that left a remarkable impact on so many. We shall forever remember his name, his wit, his smile, and his purposeful passion as he led movements and changes for TSHP and the pharmacy profession. Our deepest sympathies are extended to the Phillips Family as well as to his many friends and colleagues.

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LOCAL CHAPTER NEWS:

El Paso Area Society of Health-System Pharmacists EPASHP has always worked hard to bring value to its members and is proud to represent the El Paso Area as a Local Chapter of TSHP. During the past year and despite all the hardships and challenges that came along with COVID and the "New Normal," EPASHP continued to stay engaged with members and involved in the community by providing educational activities and community service. This was done while most of our members were serving on the frontline of the pandemic by prepping and administering vaccines. At the same time, our UTEP School of Pharmacy Students faced new learning and financial challenges. As the initial surge began early last year, the realization that we would have to cancel our Annual Frontiers In Pharmacy PostGraduate Seminar was clear. Something about the way we normally network together was suddenly changed.

For the first time in 29 years, we would not have our grand gathering. Because Continuing Education is such an important membership benefit, the annual event was modified into our first-ever virtual edition. The program was divided into three "Episodes" and offered seven hours of continuing education (CE) credit. This annual event is normally our primary revenue generator, where we rely heavily on industry sponsorship and attendance fees. However, because of the pandemic, we were unable to secure industry sponsorship. The EPASHP Leadership Team unanimously decided to offer the seminar for free to all of our members. It was our way of “Giving Back.” We sincerely appreciate the assistance TSHP provided to make this a true landmark event! We didn’t stop there! With Zoom® becoming a part of the "New Norm," we were able to conduct four additional free CE web events. For Pharmacy Month in October, the first-ever EPASHP Virtual Meet and Greet was held and an open invitation was extended to any pharmacist, technician, and industry representative who was interested in learning more about our Society. This was an excellent opportunity to introduce and showcase our leadership team. We tied this to our annual membership drive and the event was a great success! Our active presence with social media platforms on Facebook, LinkedIn, and Instagram was also getting noticed. In fact, EPASHP nearly won the TSHP Local Chapter Social Media Showdown, only to end up in second place in the last few hours of the contest. We’ll get ‘em next year!

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LOCAL CHAPTER NEWS

El Paso Area Society of Health-System Pharmacists

In doing our part in the Community, EPASHP teamed up with Pharmacy Times Continuing Education (PTCE) and The El Pasoans Fighting Hunger Food Bank. For one particular CE event, PTCE donated $25 per attendee to our local food bank. We were able to raise $1,000 for the food bank thanks to the participation of our members. In addition, some of our members donated their time during the weekends to show up onsite and sort and pack food for our neighbors in need. Our members are always ready and willing to volunteer their services for the community.

EPASHP is always giving. Throughout the past year, we awarded several free one-year EPASHP/TSHP memberships to select pharmacists, technicians, and students. We also gave away gift cards, and yes, even homemade cookies! And during the shutdown, every hospital pharmacy in El Paso still received their annual Pharmacy Week Cake from us! As the inaugural class of the UTEP School of Pharmacy Students graduated this year, we were proud to honor our graduating student members with their very own EPASHP Cord. For our remaining student members, an announcement will be made soon naming this year’s recipients of the four TSHP R&E Foundation Scholarships EPASHP has to offer. As things start to open up, we look forward to a new Better Normal! Our 30th Annual Frontiers in Pharmacy, held virtually this year in May, was a huge success! With our new leadership team in place and the experiences gained over the past year, we are ready to take our Local Chapter to the next level. As difficult as 2020-21 has been, our membership has stayed strong and participatory, and we are happy that many have taken advantage of the benefits EPASHP/TSHP has to offer. We congratulate our UTEP School of Pharmacy Students, the future pharmacists of America, for overcoming the challenges they faced. We also thank each of our members and other pharmacy colleagues for their service as Frontline workers protecting our community during the pandemic. In times like this, we are proud to be #epashpstrong! As a member-driven society, EPASHP will continue to work hard to bring value and provide benefits to its members. Hopefully, we can all be together again soon, live and in person. The networking opportunities have been sorely missed and we cannot wait to bring that back. We look forward to seeing what the NEW “Better” Normal will bring to El Paso and to our pharmacist, technician, student, and industry colleagues. Together we are #PharmacyStrong!!

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LOCAL CHAPTER NEWS:

West Texas Society of Health-System Pharmacists Meet the Rising Stars of WTSHP Katy Taylor, PharmD Transitional Care Pharmacist with the Hendrick Medical Center WTSHP New Practitioner Liaison

Why did you choose pharmacy as your career?

Pharmacy runs in my blood, and it is a field I have loved from early on. My dad is a pharmacist, and that gave me the opportunity to see upfront and personal (from a young age) the impact a pharmacist can have on individuals and the community. Pharmacists are on the front line, and patients and providers know that we are accessible and reliable. Pharmacists have the opportunity to build relationships with both patients and providers which creates daily opportunities to positively impact those around us.

What makes you passionate about what you do now?

Transitions of Care (TOC) and our Chronic Disease Management (CDM) programs provide the opportunity to interact with patients and make meaningful/significant interventions. For TOC, we work with patients upon admission to clarify their home medication list and identify barriers to adherence (cost, side effects, education, etc.), and evaluate the list for potential factors contributing to admission. We work with the nurses and providers to address the issues and create solutions. We follow these patients through their admission and provide education on their disease state(s) and medication(s), provide their medication at discharge so they leave with it in hand, and make sure they are comfortable with their discharge regimen. We are able to address financial concerns before they ever leave the hospital by working with the providers to find medications preferred on their insurances' formulary, providing co-pay cards, or offering our CDM program to uninsured patients, which allows us to help with medication access and Patient Assistance Programs postdischarge. These interventions have shown to increase patient satisfaction and compliance, while also decreasing readmissions. Through the CDM program, we are able to identify high-risk patients and provide discounted medications, education, and close follow up to help the patient reach their health goals while also preventing readmission. In both of these roles, I am able to directly interact with patients and get a glimpse of their lives and make a small (but meaningful) impact, while also working with their provider. In the midst of the chaos of hospitalization and navigating their health concerns, patients can rest easy knowing they have a pharmacy team on board and ready to address any need or concerns that arise, and that we will continue to be available post-discharge. Together, these programs help patients succeed and improve their quality of life.

What are your goals for this role/these roles in the future?

Transitions of Care is a relatively new role for pharmacy, and I would love to see more health systems pick this up. We have seen firsthand the impact the program has on quality and readmissions. My goal is to grow the program so that every single patient meets with a pharmacist so that we can identify and eliminate barriers in ways that other professions can't or don't know how to. We are in a unique position to be able to impact patient care across the board. As the role of the pharmacist continues to expand, so does our opportunity to make meaningful interventions.

How do you see membership in WTSHP/TSHP as a benefit to you in your current role?

Membership in WTSHP/TSHP has already benefited me and this current role by offering both education and mentorship. As a new pharmacist, I am always looking for ways to improve and grow. Having mentors has impacted my day-to-day pharmacist life (counseling tips and phrasing, workflow and organization, work/life balance, etc.) and in "big picture" ways (such as career goals). Many of these pharmacists that have impacted my career may not realize I view them as a mentor, but they have so much to offer and I am thankful for their example. Additionally, in this first year of practice, I have noticed how easy it can be to fall behind on the latest guidelines and new medications. WTSHP/TSHP has helped me stay up to date on new information to provide the best care possible to my patients.

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LOCAL CHAPTER NEWS

West Texas Society of Health-System Pharmacists

Grace Zalesak, PharmD Inpatient Pharmacy Supervisor at Hendrick Medical Center WTSHP Secretary

Why did you choose pharmacy as your career? I chose pharmacy as a career because I knew I wanted to help people in a healthcare capacity, and I loved the wide variety of career opportunities that pharmacy has to offer.

What makes you passionate about what you do now?

Things in pharmacy are always changing. As a supervisor, I am passionate about helping our team stay informed and adapt to changes as seamlessly as possible.

What are your goals for this role/these roles in the future?

My goal as a supervisor is to continually work on developing my own skills as a leader to help my team enhance communication and develop their own skills to be able to better serve our patients.

How do you see membership in WTSHP/TSHP as a benefit to you in your current role?

TSHP and WTSHP membership is a great benefit in my role. The TSHP Annual Seminar is an especially great opportunity to network and stay up-to-date with all the relevant CE that is offered.

Bradi Williams, PharmD Pharmacist at Hendrick Health Medication Management Clinic

Why did you choose pharmacy as your career?

Partly because my Mom is a pharmacist. Pharmacy has been a career that has been good to her and I have seen her develop personal relationships with patients. I have always been interested in the world of medicine. Pharmacy is a way that I get to be a part of that world in a way that best fits with my skill set.

What makes you passionate about what you do now?

I love what I do now! I am blessed to work with a great pharmacy team, physicians, and nurses. This clinic includes three pharmacists with collaborative practice agreements (CPA) between 11 different primary care physicians in Abilene. Our CPAs cover hypertension, hyperlipidemia, diabetes, COPD, and smoking cessation. It provides the opportunity to create an interdisciplinary team outside of the inpatient setting focused on patient care. I absolutely love working with patients. It is very fulfilling to assess a patient and help them work through treatment barriers. Our main focus so far has been chronic diseases. These chronic diseases are so prevalent which allows us to work with a large variety of patients. I enjoy the journey with patients working on their lifestyle modifications as well as their medication options. We are very accessible to these patients and create close follow up for outcomes and compliance.

What are your goals for this role/these roles in the future?

This role allows me to help patients decrease the risks associated with other comorbidities. I would love to see our clinic continue to expand in ways that could include other CPAs, other physicians, and of course more patients.

How do you see membership in WTSHP/TSHP as a benefit to you in your current role?

This organization provides education and seminars but most important to me is being involved with other professionals sharpening our pharmacist skills.

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LOCAL CHAPTER NEWS:

Gulf Coast Society of Health-System Pharmacists Greetings from GCSHP! The past 18 months have certainly been challenging for all, but we are hopeful that brighter days are ahead. As the largest local chapter of TSHP with over 400 members, GCSHP members are a true representation of the cultural and geographical diversity within the health-system pharmacy workforce and the Houston/Gulf Coast area. GCSHP aims to provide value to all its members through professional growth and development, opportunities to interact with colleagues throughout the region, and promotion of the profession. Despite the pandemic, multiple weather catastrophes, and other national crises this year, GCSHP has continued to provide opportunities for member engagement. Although we have had to adapt to seeing one another via our tablets and computers, this past year's board has accomplished many new initiatives. To increase direct membership involvement and organization visibility, GCSHP has initiated monthly meetings for all general membership. Our organization has continued to offer our members meaningful learning opportunities, including law and opioid continuing education (CE) sessions provided by Kathy Salinas, RPh from the Texas State Board of Pharmacy to assist our members in meeting their licensure renewal requirements. The board also developed TSHP-approved resident-led clinical CE presentations that are held in conjunction with our monthly meetings allowing GCSHP to offer our members more CE than ever before! Social connection and networking have never been more challenging than during the pandemic, but our virtual trivia nights allowed us to reconnect COVID-style via Zoom®! In April, GCSHP welcomed in their newly elected officers and chairs for 2021-2022: Jordan Burdine, President; Thomas Roduta, President-Elect; Laura Blackburn, Immediate Past President; Chibuokem Amuneke-Nze, Recording Secretary; Niha Zafar, Communications Secretary; Amanda Beck, Treasurer; Telyssa Anderson, Director 1; Christina York, Director 2; and Niaz Deyhim, New Practitioner Ambassador. Reba Forbess, Natalie Finch, Rick Ulasewich, and Samantha Hanner will be staying on as our Membership, Education, Industry, and Technician Chairs, respectively. Qasim Adil will be joining Natalie as her Education CoChair. We also have three newly appointed chairs, Alan Luu, Noor Zaidan, and Joy Speaks, for Website, Social Media, and Newsletter, respectively. GCSHP is also lucky to have three colleges of pharmacy in our area. We are excited to introduce our 2021-2022 student liaisons: Catherine Vu, University of Houston; Destiny Riddle, Texas Southern University; and Sharon Halliburton, Texas A&M University College of Pharmacy. In true COVID fashion, GCSHP President, Jordan Burdine, inducted the new student officers from the University of Houston College of Pharmacy via Zoom®.

The GCSHP Board of Directors met for the first time in person since the beginning of the pandemic in June and are excited to gather once again with all members in person starting September 2021! Keep an eye out for local general membership meetings, networking opportunities, and more! To keep connected, you can follow GCSHP on Facebook, Twitter, and Instagram.

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Reasons to choose Auto-Renew

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Your TSHP membership made simple! Select auto-renew. For membership assistance, please email membership@tshp.org.

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2021 TSHP Member Recognition Awards LOURDES M. CUELLAR CIRCLE OF EXCELLENCE AWARD WINNERS: Todd Connor, PharmD, MS Mike De Luna, PharmD Reba Forbess, PhD, PharmD Daniel Nyakundi, CPhT, RPhT Ardath Plauche, PharmD, RN, BCPS, BCIDP Justin Shanks, PharmD, BCPS Wesley Wells, PharmD, BCPS, BCPPS

DISTINGUISHED SERVICE AWARD WINNER:

Jennifer Ridings-Myhra, MEd, RPh Assistant Dean for Experiential and Professional Affairs Clinical Associate Professor The University of Texas at Austin College of Pharmacy

LEWIS S. SMITH PHARMACY PRACTITIONER AWARD

NEW PHARMACIST AWARD Joseph Nguyen, PharmD, MBA

Katie Morneau, PharmD

Lead Clinical Pharmacist Texas Health Harris Methodist Hospital Fort Worth

Clinical Pharmacy Specialist South Texas Veterans Health Care System

PHARMACY MENTOR AWARD

David Wallace, PharmD, RPh

Clinical Associate Professor and Director of Co-Curriculum University of Houston College of Pharmacy

INDUSTRY SERVICE AWARD

Jesse Chaffino Pharmaceutical Healthcare Representative

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INNOVATIVE COLLABORATIVE PRACTICE AWARD HCA Houston Healthcare Kingwood Clinical Pharmacists

2021 TSHP Member Recognition Awards MIKE KNAPP PHARMACY TECHNICIAN AWARD

PHARMACY LEADERSHIP AWARD

Daniel Nyakundi, CPhT, RPhT

Mallory Gessner-Wharton, PharmD, MS, BCPS

Pharmacy Resource Specialist Memorial Hermann Memorial City Hospital

Director of Pharmacy HCA Houston Healthcare Kingwood Medical Center

Get your TSBP-required CE free with your TSHP Membership! Over the course of this year, TSHP will be releasing CE designed to meet your renewal needs. Gain CE credit in law, pain management, sterile compounding, and more!

To learn more or complete the TSBP-required law CE, click here or visit https://www.lecturepanda.com/a/21110.

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2021-2022 TSHP Educational Program Preview TSHP CE Preview: Don’t Miss These Upcoming Programs! TSHP is pleased to share a preview of the upcoming continuing education (CE) programs for the 2021-2022 Leadership Year (through May 2022). We hope that you will be able to join us for the below programs and events. More information about these programs will be sent closer to each event. Questions regarding programs can be sent to registration@tshp.org.

Required Renewal CE – Free Quarterly Virtual Events for Members Each quarter, TSHP members will be able to access one of the required (TSBP & PTCB) renewal programs online, as a free member benefit! Over the course of this year, TSHP will be releasing CE designed to meet your needs. Gain CE credit in law, pain management, sterile compounding, and more. You’ll continue to have access to this free education as long as you maintain your TSHP membership. We’ll be sharing more about this member benefit as the year continues. Take advantage of your membership and obtain your free 1-hour law credit today. To learn more or complete the course visit https://www.lecturepanda.com/a/21110.

Access Education Online via the New TSHP Virtual Learning Platform TSHP will launch a new virtual learning platform in September, which will include recorded content from Annual Seminar, the recent Emergency Department & Trauma Seminar, and other events. The platform will also include free CEs for members so be sure to check this out later this year!

New Certificate Programs Launching This Fall TSHP is excited to announce two new certificate programs that will be offered beginning this fall. The Medication History Certificate Program is geared towards technicians looking to advance their skills and also sit for the PTCB Medication History Certificate Exam. The Transitions of Care Certificate Program is tailored to pharmacists looking to expand their practice. Registration will open shortly so watch your email for more information!

Continued Focus on Bringing Quality Specialty Programming to Texas TSHP will continue to offer hematology & oncology and ambulatory care webinars throughout the year and is pleased to announce the addition of neonatal & pediatrics and infectious disease programming as well!

Planning a Return to In-Person Programming for the 2022 Annual Seminar TSHP is looking forward to seeing members in person at the 2022 Annual Seminar, May 13-15, at the Kalahari Resort in Round Rock. TSHP continues to monitor the situation related to COVID-19 and will share any changes with members closer to the event but we remain hopeful that we will be able to see each other soon.

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87th Legislative Session Report by Stacey Mather, TSHP Executive Director

The Texas 87th Legislative Session was incredibly unique as COVID limitations meant that many legislative meetings were conducted virtually and the Capitol’s halls were often empty. Despite the limitations, TSHP was still out in full force, advocating for patient care and the advancement of the profession. Below are summaries of the issues we advocated on during the 2021 legislative session and how TSHP continues to advocate for you and the profession. During legislative sessions, you can get weekly updates from TSHP Advocacy calls open to all members. Specific bill language can be accessed via the bill links and questions may be directed to Stacey Mather, TSHP Executive Director.

Attempts to Address White Bagging Practices Rep. Eddie Lucio III (2020 TSHP Legislative Award Recipient) filed two bills on behalf of TSHP to address white bagging during the 87th Legislative Session. HB 1584 would have prohibited the redispensing of a drug requiring additional preparation or compounding after it had been originally dispensed. HB 1586, and a similar bill filed by Sen. Schwertner, SB 1161, would have permitted a person covered under a pharmacy benefit contract to obtain a specialty drug from a hospital outpatient infusion center or physician’s office without additional fees to the patient or reimbursement reductions to the pharmacy. TSHP partnered with the Texas Hospital Association (THA) and provider groups to advance these bills. TSHP 2020-2021 President Sarah Lake-Wallace testified in March before the House Insurance Committee and shared the challenges that patients were facing increased costs and being forced to change sites of care due to insurance restrictions highlighting stories of patients of disjointed and altered care plans. However, the opposition was out in full force, arguing that the bills would raise the cost of insurance, harming Texans. While HB 1584 died in committee, HB 1586 managed to be passed from the Texas House minutes before the deadline. While every effort was made to push forward, the clock ran out before the bills were able to be passed from the Senate. TSHP appreciates the efforts of our partners, including THA. Despite these challenges, language within recent legislation on PBMs (HB 1763 discussed below) may yet provide some relief with white bagging until further steps can be taken to address these dangerous practices as plans for efforts in the next regular legislative session are underway.

Providing Medication Therapy Management Services to Medicaid Beneficiaries HB 2658, a Medicaid omnibus bill filed by Rep. Frank, includes language by Sen. Kolkhorst that directs the Texas Health and Human Services Commission (HHSC) to collaborate with Medicaid managed care organizations to implement medication therapy management services to lower costs and improve quality outcomes for recipients by reducing adverse drug events. This bill was passed, taking effect in statute on September 1st, 2021, with the rulemaking process to follow. TSHP expects to be actively involved in the implementation of these services.

Securing Liability Protections for Healthcare Providers for Claims Related to a Pandemic SB 6, filed by Sen. Hancock, provide liability protections for healthcare providers for claims related to injuries or deaths arising from care, treatment, or failure to provide care of treatment related to or impacted by a pandemic, except in a care of reckless conduct or intentional willful, or wanton misconduct. The bill was passed and took effect June 14th, 2021.

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87TH LEGISLATIVE SESSION REPORT Patients Benefit from Drug Savings, Cost Sharing, and Accessing Emergency Refills on Insulin or Insulin-Related Supplies Many bills were filed to address insulin cost-sharing, emergency refill access, and ways to reduce costs of prescription drugs for uninsured patients. SB 827, one of the insulin cost-sharing bills filed this session, was filed by Sen. Kolkhorst and prohibits certain health plans and pharmacy benefit managers (PBM) from imposing a cost-sharing provision for insulin that is included in their formulary if the total amount the patient is required to pay exceeds $25 per prescription for a 30-day supply, regardless of the amount or type of insulin needed to fill the enrollee’s prescription. The bill was passed and the benefit takes effect January 1st, 2022. HB 1935, filed by Rep. Busy, allows pharmacists to provide an emergency refill of insulin or insulin-related equipment or supplies, for up to a 30-day supply, under certain parameters. The bill was passed and the benefit takes effect January 1st, 2022. HB 18, filed by Rep. Oliverson, establishes a prescription drug savings program to provide uninsured patients access to prescription drug benefits. The program, which allows HHSC to establish a trust fund made up of gifts, grants, federal funds, drug rebates, and other forms of support, will partner with a PBM to offer prescription drugs at a discounted rate. The bill was passed and the statute takes effect September 1st, 2021, with rulemaking by Insurance Board to follow.

Securing Pharmacy Benefit Manager (PBM) Reforms Several PBM reform bills were filed during the 87th Legislative Session and TSHP partnered with pharmacy allies to support their efforts in PBM reform. Bills filed by Rep. Tom Oliverson (HB 1763) and Rep. Harris (HB 1919) take significant strides towards addressing the challenges presented to patients by PBMs. Language included in the bills will prohibit PBMs from steering patients to PBM-owned or affiliated pharmacies and prohibiting pharmacies, including those in a hospital setting, from dispensing drugs that the pharmacy is licensed to dispense. Both bills were passed and signed by the Governor, taking effect on September 1st, 2021.

Continued Attempts to Advance Pharmacist- and Technician-Delivered Services Several bills were filed this year to advance pharmacist-delivered services. Many of these efforts were in hopes of maintaining care opportunities that were made possible under the federal CARES Act. TSHP supported our pharmacy allies’ efforts; however, none of the bills were passed this session. HB 678, filed by Rep. Cortez with a companion bill filed by Sen. Blanco, would have allowed pharmacists to order or administer an immunization or vaccination to a patient who is at least three years of age. The bill would have also allowed pharmacists to delegate the authority to administer an immunization or vaccination to a certified pharmacy technician. The bill was passed from the House; however, it did not receive a hearing in the Senate. HB 2049, filed by Rep. Howard, would have allowed pharmacists, under a physician’s written protocol, to furnish a prescription drug to treat strep throat or influenza following a positive Clinical Laboratory Improvement Amendment of 1988-waived test. The bill was voted out of the House Public Health Committee; however, it died in Calendars Committee.

Physician Dispensing Bills Continued to be Filed Multiple physician dispensing bills were filed; however, none of the bills received a committee hearing this legislative session.

Be a pharmacy advocate by serving as a Key Contact! 20

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TSHP invites you to be a part of the TSHP Key Contacts Program, which helps pharmacists establish relationships with legislators and act as an advocate at the grassroots level. Key Contacts are provided training and assistance, and no experience is needed – just a willingness to get involved and be a pharmacy advocate at the Capitol! For more information, advocacy@tshp.org

contact

the

TSHP

Office

2021-2026 TSHP Strategic Plan The TSHP Board of Directors approved the 2021-2026 TSHP Strategic Plan in June 2021. The strategic plan will help guide TSHP in its efforts to advance the pharmacy profession and meet the needs of pharmacy professionals throughout Texas.

Goal: Cultivate a vibrant, diverse and representative membership. Objective: Grow membership and promote retention for all members. Objective: Enhance the value of membership for all members. Objective: Strive to achieve diversity in membership that reflects the diversity of the Texas pharmacy profession. Objective: Develop future TSHP leaders to foster organizational growth.

Goal: Be an innovative, forward-thinking organization that advances pharmacy practice. Objective: Advance payment for clinical pharmacy services. Objective: Expand patient access to clinical pharmacy services. Objective: Promote pharmacy practice that utilizes the full extent of each pharmacy professional’s education, training, and experience. Objective: Support pharmacy practices and the efficient use of technology to improve safe patient care.

Goal: Promote the value of pharmacy practice in optimizing patient care.

Objective: Engage with the community through communication and outreach. Objective: Foster interprofessional collaboration across health systems and other professional organizations. Objective: Facilitate the needs of a changing practice among TSHP members and the community. Objective: Disseminate research and scholarly efforts that demonstrate the value of pharmacy services.

Goal: Perpetuate the ongoing professional growth and development of our diverse membership. Objective: Identify, expand, and support the professional development needs of the pharmacy workforce. Objective: Enhance education and training that advances pharmacy technician practice. Objective: Enhance education and training that advances pharmacists’ practice. Objective: Partner with key stakeholders to enhance the education and training of pharmacy learners. Objective: Foster member networking and engagement. Objective: Develop leadership skills and opportunities for members.

Goal: Foster the human and financial resources of TSHP. Objective: Sustain a high-performing TSHP team by providing appropriate resources and support to TSHP staff, volunteers, and leaders. Objective: Optimize financial health to enhance organizational stability and adaptability. Objective: Diversify revenue streams to align with comparable professional organizations.

TSHP Thanks Strategic Planning Task Force Members for their Service

TSHP would like to thank the members of the 2020-2021 Strategic Planning Task Force for their tireless efforts to draft the 2021-2026 Strategic Plan:

Ardath Plauche, Chair Latresa Billings M. Lynn Crismon Sondra Davis Lauren Goldberg DeeDee Hu Brian Irons

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Sarah Lake-Wallace Randy Martin Daniel Nyakundi Sidney Phillips Ballard Saul Ban Vu Wesley Wells

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Texas Prescription Drug Monitoring Program Evolution and Outcomes 10

Robert Hutchison, PharmD, BCACP

Joseph Carhart, PhD

Clinical Associate Professor at Texas A&M Irma Lerma Rangel College of Pharmacy

Epidemiologist at Appriss Health located in Louisville, KY

Megan G. Holloway, JD

Krista Whalen, PhD

General Counsel at Texas State Board of Pharmacy

Epidemiologist at Appriss Health located in Louisville, KY

Purpose: To describe how Prescription Drug Monitoring Programs (PDMPs) have evolved with respect to proximal outcomes (e.g., effect on opioid prescribing, effect of clinician access as a tool in the opioid epidemic). Methods: Texas prescribing data were extracted from the Texas PDMP public-use data file. De-identified longitudinal data from state and national databases for opioid prescriptions and overdose deaths in Texas between 2018 and 2020 were analyzed. Results: Prescriptions in the state of Texas for opioids decreased to 43% of the total controlled medications dispensed across the entire period (2018-2020). Hydrocodone was the most widely prescribed opioid (31%), followed by tramadol (27%) and codeine (26%). The percentage of patients with a daily morphine milligram equivalent (MME) of ≤ 50 increased during the current study, from an average of 84.9% in 2018 to 87.1% over two years; while at the same time MME > 50 decreased. The percentage of patients with multiple patient episodes in a single month decreased from an average of 3.27% to 2.58%. The growth of the Texas PDMP is reflected in the number of active Texas prescribers from 7% in 2018 to 68% in 2020.

KEYWORDS: Opioid Prescription Drug Monitoring Programs Pain Management Opioid Misuse Substance Use Disorder Hydrocodone Tramadol Morphine Milligram Equivalent

Address correspondence to: Robert Hutchison, PharmD, BCACP Address: College of Pharmacy, Texas A&M University, 3950 North AW Grimes Rd, Office 313-S Round Rock, Texas 78665 USA. E‐mail: hutchison@tamu.edu

Conclusions: The Texas PDMP has evolved into a sophisticated tool in the opioid epidemic. Migration directly into the electronic medical record allows clinicians to utilize the PDMP tools to improve the balance between optimizing pain management and excessive accessibility of opioids. Mandatory access to Texas PDMP has resulted in reductions in the opioid prescribing behavior as expected.

PURPOSE United States (US) prescription drug monitoring programs (PDMPs) are defined as state‐level databases used as tools to assist prescribing and measure trends in the use of controlled substances. These programs are heterogeneous between states, but all are designed to close the gap between opioid misuse and optimal pain management. Even within each state, programs have dramatically evolved over time. A standardized model in Texas is described along with proximal outcomes.

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Texas Prescription Drug Monitoring Program Evolution and Outcomes

The objective of this study is to describe the historical evolution of PDMPs and highlight the state of Texas PDMP with respect to proximal outcomes (e.g., effect of PDMPs on opioid prescribing, effect of clinician access and utilization as a tool in the opioid epidemic). Prescribing data were extracted from the Texas PDMP public use data file, the statewide monitoring program administered by the Texas State Board of Pharmacy (TSBP). This database represents all prescription data for Schedule II, III, IV, and V controlled substances dispensed in Texas or for Texas residents.

HISTORICAL BACKGROUND Historically, since 1993 federal legislation has supported the formation of state based PDMPs and they have become an essential component of federal and state governments' response to the opioid epidemic. However, the enactment, implementation, and integration varied significantly among individual states. 49 states, Puerto Rico, Guam, Military Health Services, and the District of 1,2 Columbia have operational PDMPs or passed legislation to operate a PDMP. Although PDMPs in the US have commonalities in terms of centralized statewide data systems that electronically transmit prescription data, the administrative features of PDMPs are heterogeneous among states. For example, not all states provide integration which is defined as integrating data contained within the PDMP with an electronic medical record (EMR). Programs operate under different regulatory agencies, collect different types of data, require data to be updated at different intervals, and allow access to different groups of people. 3 The Texas PDMP collects and monitors prescription data for all Schedule II, III, IV, and V controlled substances. Pharmacies are obligated to report required information regarding controlled substance prescriptions to the PDMP no later than the next business day after the prescription is filled. In an earlier review, Finley and colleagues’ scoping review summarized the PDMPs literature and found inconsistent and mixed evidence to support any impact.2 However, a recent systematic review funded by the National Center for Injury Prevention and Control, the Centers for Disease Control (CDC) and Prevention, and the National Institutes of Health examined whether PDMP implementation within the US is associated with changes in prescription opioid-related outcome domains: opioid prescribing behaviors, opioid diversion and supply, opioid-related morbidity and substance use disorders. 1 Of the 16 studies examining PDMPs and prescribing behaviors, 11 found that implementing PDMPs reduced prescribing behaviors.1 All three studies on opioid diversion and supply reported reductions in doctor shopping for prescription opioids, oxycodone, morphine, methadone, and hydrocodone. In the opioid-related morbidity and substance use disorders domain, seven out of eight studies found associations1 with prescription opioid-related outcomes including fewer opioid related and inpatient drug rehabilitation admissions.1 Emerging evidence indicates that proactive and integrated state PDMPs, which require mandated use, are associated with positive trends of reductions in opioid prescriptions, opioid diversion and supply, and opioid-related morbidity and substance use disorder outcomes.4-8 Studies have reported that many clinicians find PDMPs useful as a tool for communication and interaction with patients. 9 With patient prescription history at their disposal, prescribers can verify the patient’s current prescriptions to avoid doctor shopping or drug abuse but also circumvent potentially dangerous non-controlled drug interactions. Prescribers may also monitor the use of their own Drug Enforcement Administration (DEA) number to detect forged or stolen prescriptions. Prescribing guidelines combined with requirements to consult the PDMP have reduced opioid-related fatalities by 27% in Washington. 10 Florida experienced similar positive results in reducing the volume of prescriptions after PDMP viewing was integrated into the prescriber’s workflow. 11

METHODS Prescribing data were extracted from the Texas PDMP public use data file, the statewide monitoring program administered by the TSBP. This database represents all prescription data for Schedule II, III, IV, and V controlled substances dispensed in Texas or for Texas residents from a pharmacy located in another state. De-identified longitudinal data from public state and national databases for opioid prescriptions and overdose deaths in Texas between January 2018 and October 2020 were analyzed. A formal review by the institutional review committee determined the research is exempt. Drug type (e.g., opioid, sedative, stimulant) was defined based on the descriptions supplied to the Food and Drug Administration (FDA) by the manufacturer or distributor or as identified in DailyMed or First Databank. Drug schedule (i.e., II, III,

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IV, and V) was in accordance with the classifications set forth by the DEA. 12 The morphine milligram equivalent (MME) was calculated using the conversion factors available and equation provided by the CDC, or comparative studies. 13 The total daily MME for each patient was categorized as ≤ 50 MME and > 50 MME. Patients with multiple provider episodes (MPEs) were identified as those visiting four or more distinct providers and four or more distinct pharmacies within a calendar month. The rate over time of Gateway Integration, defined as an integration of PDMP information into the EMR, was measured. Prescriber integration was defined as the number of prescribers licensed in Texas who performed a patient search in the prior 18 months (beginning of integration to last study measurement) divided by the number of prescribers in Texas with a valid DEA number who wrote a prescription for a controlled medication during the same time frame. Patient report views were defined as any PDMP request that was manually requested by a provider. Patient searches automatically triggered by admissions, discharges, and/or transfers were not counted as a report view and these data requests were quantified separately. Descriptive statistics (e.g., frequencies, 30-day rolling averages, percentages) and trend analyses (e.g., segmented regression) were used to assess proportional differences and changes over time for each outcome.

RESULTS Prescriptions for opioids slightly decreased to 43% of the total controlled medications dispensed across the entire period (20182020). Hydrocodone was the most widely prescribed opioid at 31%, followed by tramadol at 27% and codeine 26%. Opioid volume trended downward over the two-year period (Figure 1). The percentage of patients with a daily MME of ≤ 50 increased over the study period, from an average of 84.9% in 2018 to 87.1% in 2019 and 87.1% in 2020. Daily MME of ≥ 50 decreased over the study period (Figure 2). From 2018 to 2020, the percentage of patients receiving any opioid from four or more prescribers and dispensing at four or more pharmacies in a single month also trended downward from an average of 3.27% in 2018 to 2.58% in 2020 (Figure 3). The number of active prescribers in Texas registered to use the PDMP has dramatically increased. In 2018 only 7% of all active prescribers were registered to use the PDMP. As of October 2020, 68% of all active prescribers were registered to use the PDMP. The Texas PDMP has rapidly become integrated into the EMR (Figure 4 and 5). Figure 1

Figure 2

Decline in Opioid (Narcotic) Prescriptions

Morphine Milligram Equivalents (MME) Prescriptions

Figure 3

Figure 4

Decline in Patients Receiving Any Opioid from 4+ Prescribers and Dispensing at 4+ Pharmacies in a Single Month

Percentage of Integration Over Time

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Figure 5 Increase in Texas PDMP Report Views

DISCUSSION Unique PDMP characteristics Texas PDMP has evolved on many levels in recent years. The advances include an increase in the reporting frequency, expanding the drug schedules monitored, and initiation of inter-state data sharing. The Texas PDMP was created in 1981 to monitor Schedule II controlled substance prescriptions. Effective September 1, 2008, the Texas Legislature expanded the PDMP to include the monitoring of Schedule III through V controlled substance prescriptions. Beginning September 1, 2016, the PDMP transferred from the Texas Department of Public Safety to the TSBP. Pharmacies report data directly to TSBP’s contracted vendor, Appriss. Effective September 1, 2017, pharmacies are obligated to report required prescription information not later than the next business day after the prescription is completely filled. The previous requirement was to report by the seventh day after the prescription was completely filled. In July 2019, the state-funded both a statewide integration into electronic health records and the tool, NarxCare. In August 2019, the threshold for monthly patient alerts sent to prescribers and pharmacies changed from five or more controlled substance prescriptions with five or more prescribers and five or more pharmacies to five or more controlled substance prescriptions with five or more prescribers and three or more pharmacies. Our approach differs slightly from the method specified by the CDC, which uses 90 day windows rather than monthly time frames. Interstate data sharing has expanded from 20 to 37 states in October 2020.

Outcomes from the mandate In March 2020, the requirement of mandatory access to Texas PDMP began. This requires the clinician to review the PDMP data before writing an opioid prescription. Mandatory access to PDMP data before writing a prescription was the most common feature among studies reporting reductions in the prescribing behaviors domain. Prior to the mandate, de-identified longitudinal data from state and national databases (for opioid prescriptions and overdose deaths in Texas) between 2013 and 2017 indicated the following: prescriptions for opioids represented over 45% of the total controlled medications dispensed across the entire period. 14 This equated to roughly 17.7 million opioid prescriptions dispensed per year, or 63.7 opioid prescriptions per 100 persons, slightly less than the reported national average. 14 Hydrocodone was the most widely prescribed opioid (32.9%), followed by tramadol (26.9%) and codeine (21.5%).14 In 2017, the overall controlled substance prescribing rate in Texas was decreasing, and the composition of opioids had shifted to a reduction in Schedule II medications (such as hydrocodone and fentanyl) and an increase in Schedule IV medications such as tramadol.14, 15 The percentage of patients with a daily MME of <= 50 increased during the current study, from an average of 84.9% in 2018 to 87.1% in 2020 (Figure 2). We hypothesize that the dip beginning in early 2020 was due to the spread of

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COVID-19 in the US and policies implemented nationwide for social distancing served as a barrier. Nonetheless, the observed trend indicates that the greatest proportion of opioids provided during the study period were associated with daily MMEs that are less ‘risky’ than higher MME categories. The Texas PDMP has rapidly become integrated into the EMR. Historically, before integration with the EMR, access was cumbersome and required a substantial time commitment from the clinician to log in. This process could take between four to ten minutes to access. Initially, the PDMPs were used primarily by non-prescribers, especially medical examiners, researchers, and law-enforcement officials. As an early rudimentary tool, the PDMP provided the standardized generic name of the drug, the dose prescribed, and the number of units dispensed; the dates of both prescribing and dispensing. 16 Integration into the EMR improves the utilization of the PDMP on a consistent basis. 8 Seamless analytical tools and an accessible pain management platform improve continuity of care, especially when using opioids. Information on potential misuse and prescription opioid diversion patterns can assist healthcare providers in striking a balance between alleviating pain and ensuring safe prescribing.3 One of the most effective approaches to preventing misuse of opioids will be to strengthen prescribing practices. This includes improving technologies to integrate reviews of prescription histories and alerts into physicians’ practices, and increased use of various tools by prescribers to minimize risks of misuse and maximize effective treatment.17 Analysis of PDMP data indicates a rapid increase in Gateway Integration (Figure 4). This is an integration into the EMR allowing PDMP information, including NarxCare metrics to be presented directly in the EMR workflow without accessing a separate web platform. Healthcare providers can access PDMP data and NarxCare analytics within their daily workflow for clinical decision support. NarxCare is a care management platform that helps prescribers and dispensers analyze real-time controlled substance data from PDMPs and manage substance use disorder. NarxCare automatically analyzes PDMP data and a patient’s health history and provides patient risk scores and interactive visualization of usage patterns to help identify potential risk factors. When the potential risk is identified, NarxCare also provides tools and resources to enable care teams to support patient needs (Figure 5). A worrisome PDMP report is one that suggests potential diversion, misuse, or abuse. Upon finding such a PDMP report, clinicians have reported a variety of responses. Ninety percent reported they would discuss the concern with the patient and 54.2% would refer patients to a relevant specialist (e.g., substance abuse or mental health clinician).18 Increasing access to treatment, improving patient education and engagement, and enabling the coordination of care across the continuum through powerful care team communications are key to success.

KEY POINTS AND CONCLUSION The Texas PDMP has evolved into a sophisticated tool in the opioid epidemic. Through migration to the EMR, clinicians have been able to utilize the PDMP tools to improve the balance between opioid prescribing and excessive accessibility of opioids in Texas. This study found that prescriptions for opioids with an MME ≥ 50 trended downward over the two-year period. The percentage of patients with MPEs in a single month has also trended downward. Through interstate sharing, the Gateway now connects 37 states and 100,000 hospitals and healthcare facilities that support almost 90 million patient encounters per month, providing the clinician seamless access to patient's complete prescription drug histories. NarxCare metrics provide support and data-driven insights and are seamlessly integrated into the EMR and pharmacy management systems. The Texas PDMP outcomes have mirrored other proactive programs in reporting reductions in opioid prescribing behavior domains. The new model of PDMP is closing the gap between opioid misuse and optimal pain management.

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DISCLOSURES Drs. Carhart and Whalen have been paid as a consultant (or in a similar capacity) by Appriss Health with a vested interest in the data being studied. Both retained the right of commenting but the corresponding author and co-author retained the right to accept or reject comments or suggestions.

REFERENCES 1. Puac-Polanco V, Chihuri S, Fink DS, et al. Prescription drug monitoring programs and prescription opioidrelated outcomes in the United States. Epidemiol Rev. 2020;42:134-53. 2. Finley EP, Garcia A, Rosen K, et al. Evaluating the impact of prescription drug monitoring program implementation: a scoping review. BMC Health Serv Res. 2017;17:420. 3. Schuler MS, Heins SE, Smart R, et al. The state of the science in opioid policy research. Drug Alcohol Depend. 2020;214:108137. 4. Fink DS, Schleimer JP, Sarvet A, et al. Association between prescription drug monitoring programs and nonfatal and fatal drug overdoses: A systematic review. Ann Intern Med. 2018;168:78390. 5. Cerda M, Ponicki WR, Smith N, et al. Measuring relationships between proactive reporting state-level prescription drug monitoring programs and county-level fatal prescription opioid overdoses. Epidemiology. 2020;31:32-42.

6. Smith N, Martins SS, Kim J, et al. A typology of prescription drug monitoring programs: A latent transition analysis of the evolution of programs from 1999 to 2016. Addiction. 2019;114:248-58. 7. Martins SS, Ponicki W, Smith N, et al. Prescription drug monitoring programs operational characteristics and fatal heroin poisoning. Int J Drug Policy. 2019;74:174-80. 8. Radomski TR, Bixler FR, Zickmund SL, et al. Physicians' perspectives regarding prescription drug monitoring program use within the department of veterans affairs: A multi-state qualitative study. J Gen Intern Med. 2018;33:1253-59. 9. Hildebran C, Cohen DJ, Irvine JM, et al. How clinicians use prescription drug monitoring programs: A qualitative inquiry. Pain Med. 2014;15:1179-86. 10. Franklin G, Sabel J, Jones CM, et al. A comprehensive approach to address the prescription opioid epidemic in Washington State: Milestones and lessons learned. Am J Public Health. 2015;105:463-9. 11. Compton WM, Boyle M, Wargo E., Prescription opioid abuse: Problems and responses. Prev Med. 2015;80:5-9.

12. Gabay M., The federal controlled substances act: Schedules and pharmacy registration. Hosp Pharm. 2013;48:473-4. 13. Frieden TR, Houry D., Reducing the risks of relief-The CDC opioid-prescribing guideline. N Engl J Med. 2016;374:1501-4. 14. Champagne-Langabeer T, Madu R, Giri S, et al. Opioid prescribing patterns and overdose deaths in Texas. Subst Abus. 2021;42:161-7. 15. Guy GP Jr, Zhang K, Bohm MK et al. Vital signs: Changes in opioid prescribing in the United States, 2006-2015. MMWR Morb Mortal Wkly Rep. 2017;66:697-704. 16. Holmgren AJ, Botelho A, Brandt AM., A history of prescription drug monitoring programs in the United States: Political appeal and public health efficacy. Am J Public Health. 2020;110:1191-7. 17. Hughes P, Denslow S, Ostrach B, et al. Exploration of the STOP Act and opioid deaths in North Carolina, 2010-2018. Am J Public Health. 2020;110:1573-7. 18. Irvine JM, Hallvik SE, Hildebran C, et al. Who uses a prescription drug monitoring program and how? Insights from a statewide survey of Oregon clinicians. J Pain. 2014;15:747-55.

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Retrospective Review of Pharmaceutical Care Services Provided by Academic Pharmacy Teams in an Inpatient Setting Charlotte Farris, PharmD, BCPS

Sydney N. Kutter, PharmD, BCPS Assistant Professor Mayborn College of Health Sciences at the University of Mary Hardin-Baylor

Clinical Assistant Professor of Pharmacy Practice Texas A&M University Irma Lerma Rangel College of Pharmacy

Delaney Ivy, PharmD, MSc, BCPS, CDE

Sebastian Perez, PharmD, BCPS

Clinical Assistant Professor of Pharmacy Practice Texas A&M University Irma Lerma Rangel College of Pharmacy

Clinical Assistant Professor University of Texas at El Paso School of Pharmacy

Purpose: Despite evidence that the provision of pharmaceutical care has demonstrated a significant impact on both clinical and economic outcomes, pharmacists continue to struggle with emphasizing their cognitive services. This study aimed to quantify and describe the scope of services provided by academic pharmacy teams in an acute care setting using the four universal drug-related needs. Methods: This retrospective chart review was conducted at an acute care teaching hospital. Interventions were identified based on a query of clinical intervention reporting data. The primary descriptive outcome of the study is the type of drug therapy need and category documented by the academic pharmacy team. Drug therapy needs were classified into four groups including indication, efficacy, safety, and convenience.

KEYWORDS: Pharmaceutical care Drug therapy problem Drug therapy need Pharmacist Academic pharmacy team

Address correspondence to: Sydney N. Kutter, PharmD, BCPS Email: skutter@umhb.edu

Results: Over a six-month period, the academic pharmacy team identified a total of 698 drug therapy problems and intervened most on the drug therapy need of indication. Within this drug therapy need, the most common drug therapy problem was nonadherence/noncompliance, followed by unnecessary drug therapy. Conclusions: The results of this study demonstrate that pharmaceutical care provided by academic pharmacy teams results in comprehensive drug therapy assessment as indicated by the relatively equal distribution of unmet drug therapy needs identified.

BACKGROUND Pharmaceutical care is defined as the provision of medication-related services intended to improve patient outcomes by optimizing medication use.1 Through this professional practice, it is expected the pharmacist will contribute to ensuring the safety and 1 effectiveness of drug therapy for the individual patient rather than factionalizing drug therapy and biological systems. According to Hepler and Strand, drug therapy problems give rise from four universal drug-related needs: (1) indication, (2) effectiveness, (3) safety, and (4) adherence. Pharmacists are trained to identify, resolve, and prevent these drug-related problems by 2 providing comprehensive medication therapy reviews to fulfill this philosophy of practice.

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Despite evidence that the provision of pharmaceutical care has demonstrated a significant impact on both clinical and economic outcomes, pharmacists continue to struggle with emphasizing their comprehensive cognitive services over those 3-5 related to a task-based approach such as product procurement, preparation, and distribution. In the inpatient setting, pharmacy services are often provided as consultative rather than a comprehensive review of a medication profile. Hence, the documentation of interventions provided in an inpatient setting largely revolves around task-based documentation as opposed to classification of drug therapy need, potentially making it difficult to capture the entirety of the impact pharmacists have in the prevention and identification of drug therapy problems when providing a more encompassing comprehensive medication review as opposed to more targeted consults. At the institution in which this research was conducted, the majority of pharmacists practice in a unit-based model where the pharmacist provides a combination of distributive and cognitive services (e.g., consultative services). In addition to these unitbased pharmacists, two general medicine units also have an academic pharmacy team composed of pharmacists and pharmacy trainees, who work alongside the multidisciplinary medical rounding team. The academic pharmacy team provides comprehensive medication profile reviews for the physician-based multidisciplinary teaching team that provides care for 10 to 15 admitted patients. The objective of this study is to quantify and describe the scope of pharmaceutical care services provided by academic pharmacy teams in an acute care setting.

METHODS Setting and Study Design This retrospective chart review was conducted at Baylor Scott and White Medical Center (BSW) a 636-bed acute care teaching hospital in Temple, Texas. Interventions were identified based on a retrospective query of clinical intervention reporting data. To be included, interventions must have been documented by a member of the Texas A&M University College of Pharmacy (TAMUCOP) academic pharmacy team from July 1, 2018, to December 10, 2018, when providing comprehensive medication therapy management services to either a family medicine or internal medicine physician team. The academic pharmacy team included two TAMUCOP acute care faculty members, one TAMUCOP post-graduate year two (PGY2) internal medicine pharmacy resident, five BSW post-graduate year one (PGY1) pharmacy residents, and TAMUCOP advanced pharmacy practice experiential students (APPE). All interventions that were accepted were included in the study. Interventions were categorized into only one category and were excluded if they had an unclear drug therapy need or category. A manual review of each intervention was performed to confirm whether the inclusion were met. Discrepancies in categorizing interventions into the drug therapy categories were reconciled by a second investigator, and in a few instances, a third investigator to increase the reliability of categorization types. The study was granted exempt status by the BSW and Texas A&M University Internal Review Board.

Outcomes The primary descriptive outcome of the study was the type of drug therapy need and category documented by the academic pharmacy team. Drug therapy needs were classified into four groups including indication, efficacy, safety, and convenience. The drug therapy needs were further broken down into drug therapy categories within each drug therapy need that included: indication (unnecessary drug therapy, needs additional therapy), efficacy (ineffective drug, dosage too low), safety (adverse drug reaction, dosage too high), or convenience (current or potential for nonadherence or noncompliance). Examples of the respective drug therapy needs include: 1) indication - the patient is on an antibiotic but doesn’t have an infectious condition, 2) efficacy - the patient is receiving insulin at an inadequate dose based on blood glucose levels, 3) safety - the patient is receiving a beta-blocker and is experiencing hypotension, and 4) convenience - the patient is non-compliant with home medications and would benefit from discharge counseling. Based upon the drug therapy need, appropriate actions were taken to identify or address the drug therapy need (i.e., if the patient’s drug therapy need was indication due to the patient being on an antibiotic that was not indicated, the action taken was to recommend discontinuation of the drug).

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Statistical Analysis Descriptive statistics were performed on all study variables. Continuous variables were summarized as means, medians, and ranges. Categorical variables were summarized as frequency (n) and percentage (%).

RESULTS From July 1, 2018, to December 10, 2018, the academic pharmacy team identified a total of 698 drug therapy problems (Table 1). The interventions addressed drug therapy problems identified among a large spectra of disease states, with the five most common disease states or pharmacologic categories intervened on being: infectious diseases (19.8%), nephrology (11.9%), cardiology (11.2%), anticoagulation (9.7%), and neurology (8.3%). Approximately 17.2% of the interventions were unknown in regards to a medical condition or pharmacologic class due to a lack of documentation of the specific details of the intervention.

Figure 1. Percentage Breakdown of Drug Therapy Needs Intervened on Acute Care Patients

Table 1. Number of Documented Interventions by Academic Pharmacy Team Member

Academic Pharmacy Team Member

Figure 2. Percentage Breakdown of Drug Therapy Categories Intervened on Acute Care Patients

Table 2. Actions Taken to Identify or Address Drug Therapy Needs for Acute Care Patients

Action

Number of Interventions

Percent Composition of Interventions

TAMUCOP Advanced Pharmacy Practice Experience Students

158

Admission Medication Reconciliation

22.6

BSW Post-Graduate Year One Pharmacy Residents

215

Dose Change

18.1

TAMUCOP Post-Graduate Year Two Pharmacy Resident

245

Discontinue Drug

14.9

TAMUCOP Acute Care Faculty Members

Drug Change

11.2

698

Initiate Drug

9.2

Total interventions

Discharge Counseling 6.0 During the six-month time frame, the academic pharmacy team intervened most on the drug therapy need of Order Lab 6.4 indication (Figure 1). Within the drug therapy need area of Route Change 5.4 indication, the most commonly identified drug therapy Frequency Change 3.7 problem (DTP) was nonadherence/noncompliance, followed Allergy 0.3 by unnecessary drug therapy (Figure 2). The remaining drug therapy problems intervened upon are summarized in Timing Change 0.4 Figure 1. Table 2 provides a summary of the twelve different Referral 0.1 actions taken to either identify or address drug therapy needs for these patients. Most drug therapy needs were identified during the admission medication reconciliation, and the most common action to address those needs were "Dose Change" and "Discontinue Drug."

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DISCUSSION Previous investigations from academic pharmacy teams have described the scope of interventions made, but either did not directly describe the drug therapy problems addressed or utilized their own group’s intervention categorization schema. 6-9 This investigation is the first, to the investigators’ knowledge, to categorize the scope of unmet drug therapy needs and drug therapy 1 problems that exist in a hospitalized adult patient population using the framework developed by Hepler and Strand. The results of this study demonstrate that pharmaceutical care provided by academic pharmacy teams result in comprehensive drug therapy assessment as indicated by the relatively equal distribution of unmet drug therapy needs identified. The relative equal distribution of unmet drug therapy needs indicates that the academic pharmacy teams do not focus drug therapy assessment to any single drug therapy need but instead consistently assess that all needs are being met. In addition to identifying unmet drug therapy needs among a hospitalized patient population, this study described the frequency and distribution of the drug therapy problems that exist in an adult medicine population. In the American College of Clinical Pharmacy’s Comprehensive Medication Management Services Report published in 2019, the scope of drug therapy problems is reported in aggregate.10 Among 19 distinct medication management service practices, which provided services to more than 11,000 patients, the most frequently identified drug therapy problem category is “Inadequate therapy” (56.86%), which is a composite of: “Dose too low,” “Different or additional drug needed,” and “Wrong drug.” This group’s findings appear to be consistent with those results, however, the patient populations differ. Most, if not all medication management services are delivered in a community practice setting. Therefore, this data set provides a unique, and potentially first look at the scope of drug therapy problems among hospitalized patients. This study illustrates the value of comprehensive medication management in the hospital setting through conveying the benefits of the pharmacist in all four drug therapy need categories. Given the observational nature of this study, the application of the results are limited, but the new questions it generates creates new scholarly questions, with the biggest focusing on the benefit of the provision of comprehensive medication management services in the inpatient setting compared to the more commonly encountered distributive and consultative responsibilities. It appears beneficial for pharmacists to be able to focus on a comprehensive medication review and identification of DTPs using the categories mentioned rather than specifically taskbased activities in the hospital setting. Since medication-related problems are a large reason for hospital readmission, using pharmacists to help identify these problems during an admission may help decrease health-related costs of readmission.11-12

Limitations The study had several limitations. This study’s quantification and description of drug therapy problems and the interventions made to resolve them may be imprecise due to underreporting and application of drug therapy problem categorization schema. The issue of underreporting stems from several challenges such as the time required to document interventions, the practitioners’ and students’ mastery of the categorization schema, and inconsistency across all members of the academic team to document each problem identified and intervened upon as written in the study protocol. This investigation did not attempt to investigate relationships between the pharmaceutical care services provided by the academic pharmacy team and their impact upon clinical outcomes and health care costs. The previously referred to literature on academic pharmacy services 6-9 does quantify the potential impact on potential cost savings. A recent publication from RavnNielsen and colleagues demonstrated that a multifaceted clinical pharmacist service encompassing medication profile review, patient interview, and post-hospital discharge follow-up significantly reduced 30-day hospital readmissions. 13 Future research endeavors should seek to investigate the relationship between those drug therapy problems identified and resolved versus those identified and left unresolved and clinical outcomes outside of the hospital upon discharge as well as hospital readmissions. Lastly, there was no comparison made between the academic pharmacy team and hospital staff pharmacists based upon the quantity and categories of drug therapy problems identified and the interventions made and accepted. Such comparison may be of great importance in order to investigate if any significant differences exist in the work and care provided by the academic pharmacy service and hospital pharmacy staff. If such differences exist, it would be prudent to examine the nuances in practices between both groups in order to optimize practices across both.

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CONCLUSION Through the application of the principles and processes of pharmaceutical care practice by the academic pharmacy team, drug therapy problems spanning all four drug therapy needs were identified and resolved. The relative equal distribution of unmet drug therapy needs indicates that the academic pharmacy teams consistently assess that all needs are being met. Further studies are needed to evaluate the clinical and financial impact this patient care process can have when applied consistently and accurately by a larger team of pharmaceutical care providers.

KEY POINTS This study aimed to categorize the scope of unmet drug therapy needs and drug therapy problems that exist in a hospitalized adult patient population. Pharmaceutical care provided by academic pharmacy teams results in comprehensive drug therapy assessment as indicated by a relatively equal distribution of unmet drug therapy needs identified. Academic pharmacy teams do not focus drug therapy assessment to any single drug therapy need but instead consistently assess that all needs are being met.

DISCLOSURES The authors have no disclosures.

REFERENCES 1. Hepler CD, Strand LM. Opportunities and responsibilities in pharmaceutical care. Am J Hosp Pharm. 1990;47(3):533‐543. 2. Cipolle RJ, et al. Pharmaceutical Care Practice: The Patient-Centered Approach to Medication Management Services, 3e New York, NY: McGraw-Hill; 2012. 3. Jehan M, Caballero J, Llosent M, Hinkes R. Differences in Pharmacy Interventions at a Psychiatric Hospital: Comparison of Staff Pharmacists, Pharmacy Faculty, and Student Pharmacists. Hosp Pharm. 2010;45(4):314-319. doi: 10.1310/hpj4504314. 4. Touchette DR, Doloresco F, Suda KJ, Perez A, Turner S, Jalundhwala Y, Tangonan MC, Hoffman JM. Economic evaluations of clinical pharmacy services: 2006-2010. Pharmacotherapy. 2014;34(8):771-93. doi: 10.1002/phar.1414.

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5. MacKinnon GE, III. Documentation: a value proposition for pharmacy education and the pharmacy profession. Am J Pharm Educ. 2007;71(4):73. doi:10.5688/aj710473. 6. Condren ME, Haase MR, Luedtke SA, Gaylor AS. Clinical activities of an academic pediatric pharmacy team. Ann Pharmacother. 2004;38(4):574-8. doi: 10.1345/aph.1D384. 7. Taylor CT, Church CO, Byrd DC. Documentation of clinical interventions by pharmacy faculty, residents, and students. Ann Pharmacother. 2000;34(7-8):843-7. doi: 10.1345/aph.19310. 8. Divall MV, Zikaras B, Copeland D, Gonyeau M. School-wide clinical intervention system to document pharmacy students' impact on patient care. Am J Pharm Educ. 2010;74(1):14. doi: 10.5688/aj740114. 9. Stevenson TL, Fox BI, Andrus M, Carroll D. Implementation of a school-wide clinical intervention documentation system. Am J Pharm Educ. 2011;75(5):90. doi: 10.5688/ajpe75590.

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10. Comprehensive Medication Management in Team-Based Care. American College of Clinical Pharmacy website. Accessed April 30, 2020. https://www.accp.com/docs/positions/misc/C MM%20Brief.pdf. 11. Forster, A. J., Murff, H. J., Peterson, J. F., Gandhi, T. K., & Bates, D. W. (2003). The incidence and severity of adverse events affecting patients after discharge from the hospital. Annals of Internal Medicine, 138(8), 161-7. doi: 10.7326/0003-4819-138-3200302040-00007. 12. Forster, A. J., Murff, H. J., Peterson, J. F., Gandhi T.K., & Bates, D. W. (2005). Adverse Drug Events Occurring Following Hospital Discharge. Journal of General Internal Medicine, 20, 317-23. doi: 10.1111/j.15251497.2005.30390.x. 13. Ravn-Nielsen LV, Duckert ML, Lund ML, Henriksen JP, Nielsen ML, Eriksen CS, Buck TC, Pottegård A, Hansen MR, Hallas J. Effect of an In-Hospital Multifaceted Clinical Pharmacist Intervention on the Risk of Readmission: A Randomized Clinical Trial. JAMA Intern Med. 2018;178(3):375-382. doi: 10.1001/jamainternmed.2017.8274.

Optimizing the Timing of Phenytoin Levels in the Inpatient Setting Zhou Fang, PharmD Clinical Pharmacy Specialist Division of Pharmacy, University of Texas MD Anderson Cancer Center

Brian M. Dee, PharmD, BCCCP, BCNSP, FCCM Clinical Pharmacy Specialist Division of Pharmacy, University of Texas MD Anderson Cancer Center

Kaitlin N. Highsmith, PharmD, BCOP Clinical Pharmacy Specialist Division of Pharmacy, University of Texas MD Anderson Cancer Center

KEYWORDS:

Purpose: The goal of this project was to decrease the percentage of inappropriately drawn phenytoin levels in the inpatient setting preversus postintervention following prescriber education and implementation of adjustments within the electronic health record (EHR).

Electronic health record Lab orders Medication orders Phenytoin levels Therapeutic drug monitoring

Methods: Retrospective baseline data were collected for total and free phenytoin levels drawn for phenytoin and fosphenytoin regimens in the inpatient setting at a 678-bed cancer hospital from July 1 to August 31, 2019. A protocol was developed to evaluate the appropriate timing of the phenytoin levels as peak, trough, or random. Following baseline data collection and analysis, two in-service educational sessions were conducted for neurology/neuro-oncology providers. Additionally, linked medication/lab order panels and individual lab orders were submitted for incorporation into the EHR. Following completion of the in-service educational sessions, data were similarly collected and analyzed for total and free phenytoin levels drawn from January 28 to March 21, 2020.

Address correspondence to: Zhou Fang, PharmD Email: zjfang@mdanderson.org

Results: A total of 111 pre-intervention phenytoin levels and 39 post-intervention phenytoin levels were collected over 8 weeks in each period and assessed. In the pre-intervention analysis, 68% of the levels were drawn inappropriately as random levels that did not correlate with the timing of phenytoin/fosphenytoin administration. In the post-intervention analysis following an educational intervention, 51% of the levels were drawn inappropriately. Conclusions: In-service educational sessions for providers who frequently ordered phenytoin levels led to a decrease in the percentage of inappropriately drawn phenytoin levels in the inpatient setting.

BACKGROUND Phenytoin is an anticonvulsant indicated for the treatment and prevention of generalized tonic-clonic and complex partial 1 seizures, as well as seizures related to neurosurgery. Fosphenytoin, a prodrug of phenytoin, is an alternative agent associated with a faster rate of infusion, less infusion-related cardiac toxicity and burning,

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and more paresthesia and pruritus compared to phenytoin. 2-3 Due to the narrow therapeutic range and non-linear 4 pharmacokinetics of phenytoin, therapeutic drug monitoring is important to balance efficacy and dose-related adverse effects. Various factors including drug-drug interactions, hypoalbuminemia, renal and/or hepatic impairment, and critical illness can also contribute to alterations in phenytoin pharmacokinetics. In particular, phenytoin dosing should aim to attain therapeutic plasma total phenytoin concentrations of 10-20 µg/mL and unbound/free phenytoin concentrations of 1-2 µg/mL. At supratherapeutic levels, patients may experience neurotoxic adverse effects such as nystagmus, ataxia, and dysarthria.4 Therefore, when drawn appropriately, phenytoin levels reflect medication effectiveness, dose-related adverse effects, and ultimately guide dosing. Currently, literature is lacking regarding consensus recommendations for the specific timing of phenytoin levels. Nonetheless, phenytoin levels should be timed and drawn according to the clinical situation, especially for patients who have suspected phenytoin toxicity or breakthrough seizures.4 For patients receiving an intravenous (IV) loading dose of phenytoin or fosphenytoin, a level may be drawn two hours after the dose to assess for dose-related adverse effects and to aid in determining subsequent maintenance doses.5 For patients on a new phenytoin maintenance regimen or receiving a dose adjustment, a level may be drawn within two to three days just prior to a dose for routine monitoring.6 For patients on a long-term phenytoin regimen, a level may be drawn at the point of admission regardless of normal dosing time to assess compliance, as it can be assumed these patients are at a steady state.4 It was observed at our institution that phenytoin levels were sometimes ordered to be drawn with morning laboratory tests without consideration of medication administration time or duration of therapy. These levels could be difficult to interpret, leading to inappropriate dosage adjustment and increased costs related to resource utilization. Therefore, a quality improvement project was designed to optimize the timing of phenytoin levels.

METHODS Study Design This retrospective, single-center quality improvement project was conducted at a 678-bed comprehensive cancer hospital. The project’s protocol was reviewed and approved by the institution’s Quality Improvement Assessment Board, and the project’s aim statement was to decrease the percentage of inappropriately drawn phenytoin levels in the inpatient setting by 25% preversus post-intervention. The project consisted of pre- and post-intervention data collection, a protocol to evaluate the appropriate timing of phenytoin levels, and interventions related to education for providers and linked medication/lab order panels for implementation into the institution’s electronic health record (EHR).

Data Collection Retrospective, baseline, pre-intervention data were collected for total and free phenytoin levels drawn in the inpatient setting from July 1 to August 31, 2019, whereas retrospective, post-intervention data were collected for levels drawn from January 28 to March 21, 2020. Data on phenytoin levels were collected for each unique patient medical record number (MRN) in the EHR (EPIC©) if the patient had a dose of phenytoin or fosphenytoin administered within the time period. Primary data collection was accomplished by submitting an internal service request to receive assistance from the Department of Pharmacy Medication Management and Analytics. Pertinent information related to phenytoin levels included patient MRN, type of level (total or free), time the level was drawn, and the level result. Pertinent information related to phenytoin/fosphenytoin administration included patient MRN as well as drug formulation, dosage, route, and time of administration. Secondary data collection involved manually reviewing each patient’s EHR for previous phenytoin administrations and prescriptions to identify any previous phenytoin maintenance regimens.

Data Analysis Based on phenytoin’s pharmacokinetics and an assessment of primary literature, a protocol was developed to evaluate the appropriateness of the timing of phenytoin levels. Total and free phenytoin levels were classified as peak, trough, or random levels and assessed for appropriateness according to IV or oral (PO) formulations and time of drug administration. Phenytoin could be administered as IV or PO, whereas fosphenytoin could only be administered as IV based on available dosage forms. A peak level was deemed appropriate if it was drawn two to four hours after an IV loading dose,5-6 or 8 to 24 hours after a PO loading dose. 4, 7-8

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A trough level was deemed appropriate if it was drawn within 60 minutes before an IV or PO inpatient maintenance dose.4 A random level was deemed appropriate if it was drawn once any time after admission if the patient had been receiving a long-term 4 maintenance regimen (i.e., in the outpatient setting). Based on these definitions, the administration time was manually compared to the time of the drawn phenytoin level to assign the level as appropriate or inappropriate.

Interventions Following the initial baseline data collection and analysis, educational and EHR interventions were initiated in January 2020. Education involved two in-service sessions for providers who frequently ordered phenytoin levels, notably neurology and neurooncology attending physicians, fellows, residents, and nurse practitioners at our institution. A PowerPoint presentation was delivered describing the pharmacokinetics of phenytoin, the results of the baseline data analysis, and recommendations for the appropriate timing of phenytoin levels for future reference. For the EHR intervention, requests to build two linked medication/lab order panels and six individual lab orders into EPIC© were submitted to the institution’s Division of Pharmacy Medication Management Committee and Department of Pathology and Laboratory Medicine, respectively. The order panels consisted of total and free peak phenytoin levels linked to IV phenytoin and fosphenytoin loading dose medication master files, while the lab orders consisted of further delineating total and free levels as peak, trough, or random. These proposed implementations also included additional embedded text with recommendations based on the protocol to prompt providers on when to appropriately draw phenytoin levels. Summary statistics were used in the analysis of the data.

RESULTS One-hundred and eleven pre-intervention phenytoin levels (from 19 patients) and 39 post-intervention phenytoin levels (from 18 patients) were assessed. The levels were collected over 8 weeks in each assessment period. No PO phenytoin loading doses were noted, so the criteria for assessing phenytoin peak levels from PO loading doses were not applicable. Additionally, due to a delay in implementation of the proposed order panels and lab orders into the EHR, post-intervention results were based solely on the educational intervention. In the pre-intervention phase, four phenytoin levels were drawn appropriately as peak levels, 16 as trough levels, and 16 as onetime random levels, whereas 75 (68%) were drawn inappropriately as random levels that did not correlate with the timing of phenytoin/fosphenytoin administrations (Table 1 and Figure 1). In the post-intervention phase, 7 phenytoin levels were drawn appropriately as peak levels, 7 as trough levels, and 5 as one-time random levels, whereas 20 (51%) were drawn inappropriately as random levels that did not correlate with the timing of phenytoin/fosphenytoin administrations (Table 2 and Figure 2). Therefore, the percentage of inappropriately drawn phenytoin levels in the inpatient setting decreased by an absolute difference of 17% preversus post-intervention.

Table 1: Pre-Intervention Phenytoin Levels (n = 111)

Peak

Trough

Random

Appropriately Drawn Levels, no.

Inappropriately Drawn Levels, no.

Table 2. Post-Intervention Phenytoin Levels (n = 39)

Peak

Trough

Random

Appropriately Drawn Levels, no.

Inappropriately Drawn Levels, no.

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DISCUSSION This project focused solely on the timing of phenytoin levels drawn in the inpatient setting and not on clinical outcomes nor interpretation of the levels because the reasons for ordering phenytoin levels can be highly specific to the provider and patient. At our institution, inpatient neurology/neuro-oncology services do not have devoted clinical pharmacists who can help with monitoring and assessment of phenytoin levels. Therefore, the two in-service educational sessions were important interventions that ultimately led to a decrease in the percentage of inappropriately drawn phenytoin levels in the inpatient setting over approximately eight months (from initiation of pre-intervention data collection in July 2019 to completion of post-intervention data collection in March 2020). From these results, it is evident that efforts to understand and assess the timing of phenytoin levels are important to facilitate appropriate therapeutic drug monitoring of phenytoin/fosphenytoin therapy. In a retrospective study published by Brophy et al., the authors assessed the use of phenytoin for posttraumatic seizure prophylaxis in 109 patients in the neuroscience intensive care unit over a two-year period.8 Through the involvement of a clinical pharmacist in monitoring therapy, the use of phenytoin for posttraumatic seizure prophylaxis and associated costs decreased without compromising patient outcomes. Specifically, the addition of a clinical pharmacist to the patient-care team led to a shorter duration of therapy (13.4 days pre-intervention vs. 7.6 days post-intervention), fewer seizures (4.7% vs. 1.5%), decreased number of levels drawn per patient (10.3 vs. 3.4) and percentage of inappropriately timed levels (82% vs 68%), and increased cost savings ($28,000 saved on medication administration and laboratory monitoring). Similarly, in our project, the delivery of in-service educational sessions by pharmacists led to a 17% decrease in the percentage of inappropriately drawn phenytoin levels in the inpatient setting. This result supports the impact of pharmacists on therapeutic drug monitoring and correlates with the observation that neurology/neuro-oncology providers often utilize phenytoin/fosphenytoin and order phenytoin levels at our institution. Although the decrease in the percentage of inappropriately drawn phenytoin levels in the inpatient setting did not meet the aim statement of 25%, factors that may have hindered the desired percentage decrease included a smaller post-intervention sample size of phenytoin levels and a potentially larger number of phenytoin levels being ordered by providers not receiving the educational intervention. Additionally, implementation of EHR interventions was delayed due to external circumstances, so results did not reflect all the desired interventions. Furthermore, in attempting to optimize the timing of phenytoin levels, there may have been inherent limitations related to the physical act of drawing phenytoin levels. For example, if the patient was in surgery or a healthcare provider was unable to draw the level at the pre-specified time, a subsequent delay in drawing the phenytoin level would inherently classify the level as inappropriate. Given the retrospective manner of this project and certain outliers in the pre-intervention data (i.e., individual patients having eight to ten, even up to 20 phenytoin levels), it was difficult to ascertain the extent to which the educational intervention directly decreased the total number of phenytoin levels drawn. However, the educational interventions may have given the neurology/neuro-oncology providers more knowledge on the pharmacokinetics of phenytoin, leading to a decrease in both the number of repeatedly drawn phenytoin levels and the percentage of inappropriately drawn phenytoin levels. To sustain a presumed educational impact, the PowerPoint slides from the educational sessions were incorporated into the learning documents for future trainees and faculty in the neurology/neuro-oncology department. Nonetheless, phenytoin levels continue to be inappropriately drawn as randomly timed levels in the inpatient setting at our institution. Due to the lack of literature, there is a need to increase general awareness and understanding of the timing of phenytoin levels. The in-service educational sessions were conducted for neurology/neuro-oncology providers because they frequently order phenytoin levels. However, other providers who order phenytoin levels (e.g., those from internal medicine and critical care) may benefit from education as well. In the future, studies could be conducted to evaluate the impact of EHR interventions on the timing of phenytoin levels or other outcomes such as dosage changes related to the timing and interpretation of phenytoin levels. It would also be interesting to determine if inappropriately drawn phenytoin levels can be further attributed to an ordering issue (i.e., when the provider timed the level in the lab order vs. when it was actually drawn) or a nursing implementation issue (i.e., delay in a drawn level because the nurse did not draw it at the designated time).

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CONCLUSION In-service educational sessions for providers who frequently ordered phenytoin levels led to a decrease in the percentage of inappropriately drawn phenytoin levels in the inpatient setting.

ACKNOWLEDGEMENTS Chun Feng (MA, ASQ Six Sigma Black Belt) is acknowledged for her assistance with data/patient identification during the completion of this project. Qing Meng (PhD) is acknowledged for his assistance with the implementation of lab orders into the EHR.

DISCLOSURES The authors have no disclosures.

REFERENCES 1. Dilantin (phenytoin sodium injection) package insert. New York, NY: Pfizer; 1998 Dec. Revised 2014 Jan. 2. Cerebyx (fosphenytoin sodium injection) package insert. New York, NY: Pfizer; 1996 Aug. Revised 2020 Jan. 3. Boucher BA, Feler CA, Dean JC, et al. The safety, tolerability, and pharmacokinetics of fosphenytoin after intramuscular and intravenous administration in neurosurgery patients. Pharmacotherapy. 1996; 16:638-45. 4. Wu MF, Lim WH. Phenytoin: a guide to therapeutic drug monitoring. Proc Singapore Healthc. 2013; 22:198–202.

5. Meek PD, Davis SN, Collins DM, et al. Guidelines for nonemergency use of parenteral phenytoin products: proceedings of an expert panel consensus process. Panel on nonemergency use of parenteral phenytoin products. Arch Intern Med. 1999; 159:2639-44. 6. Winter ME. Basic Clinical Pharmacokinetics. 5th ed. Pennsylvania: Lippincott Williams & Wilkins; 2011:355-402. 7. Osborn HH, Zisfein J, Sparano R, et al. Single-dose oral phenytoin loading. Ann Emerg Med. 1987; 16:407-12. 8. Brophy GM, Tesoro EP, Schrote GL, et al. Pharmacist impact on posttraumatic seizure prophylaxis in patients with head injury. Pharmacotherapy. 2002; 22:251-55.

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TSHP Research & Education Foundation Poster Competition

2021 Winners The TSHP Research & Education Foundation Poster Session and Competition occurs each year at the TSHP Annual Seminar. The poster session is an opportunity for Seminar registrants to display original scholarly work in poster format. If applicable, posters can compete in one of seven categories. Categories: Posters can be submitted for Display-Only or compete in one of seven (7) categories: 1. Resident/Fellow/Post-Graduate PGY1 Category includes posters submitted by pharmacists enrolled in a PGY1 post-graduate residency, fellowship, or other post-graduate educational programs. 2. Resident/Fellow/Post-Graduate PGY2 Category includes posters submitted by pharmacists enrolled in a PGY2 post-graduate residency, fellowship, or other post-graduate educational programs. 3. Student Category includes posters submitted by student pharmacists enrolled in pharmacy academic programs. 4. Technician Category includes posters submitted by practicing pharmacy technicians and technician students. 5. Practitioner Administrative/Practice Management Category includes posters submitted by registered pharmacists relating to professional practice management issues and leadership. 6. Practitioner Clinical Category includes posters submitted by registered pharmacists relating to patient care delivery, therapy, and outcomes. 7. Practitioner Education Category includes posters submitted by registered pharmacists relating to the patient, healthcare practitioner, and community education, and/or educational planning, development, and conduct for professional practice. The 2021 TSHP Research and Education Foundation Poster Competition took place at the 2021 Virtual Annual Seminar, April 9-11th. The Foundation is proud to offer abstracts for the four 2021 winning posters. Click on each poster image to view larger. The 2022 Call for Posters will open in December 2021. For full competition details, visit www.tshp.org/poster.

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TSHP Research & Education Foundation Poster Competition 2021 Winners

PRACTITIONER – CLINICAL Evaluation of the efficacy and safety of sodium zirconium cyclosilicate and sodium polystyrene sulfonate in treatment of hyperkalemia CC Ike, AN King, AJ Hunter Houston Methodist Sugar Land Hospital, Sugar Land, Texas Background: Hyperkalemia is defined as a serum potassium concentration > 5 – 5.5 mEq/L. When potassium levels exceed 6.5 mEq/L or electrocardiogram changes are present, sodium polystyrene sulfonate (SPS) or sodium zirconium cyclosilicate (SZC) can be used as adjunctive therapies for treatment. Objective: To evaluate the efficacy, safety and cost effectiveness of SZC versus SPS in hospitalized patients with hyperkalemia. Methods: A retrospective chart review was performed at a community hospital after switching from SPS to SZC. Patients ≥18 years with administration of at least one dose of SPS or SZC were included. A sample of 50 patients were selected from each group. Results: Baseline characteristics, such as average age, serum creatinine, potassium and time to first repeat potassium level were similar between groups. Serum potassium levels for SCZ vs. SPS were 5.2 vs. 4.7 mEq/L (p = 0.03) at 8-12 hours and 4.9 vs. 4.5 mEq/L (p = 0.01) at 12-24 hours post-administration respectively. There was no difference in rate of edema between the two groups[SZC=14% vs. SPS=22% (p=0.44)]. Utilizing two SZC 5 g doses over SPS yields an average cost savings of $0.53 per dose(p=0.89). Using one 10 g dose of SZC (vs. two 5 g doses) would realize an additional $13.90 in cost savings per dose (p=0.0002). Conclusion: The results suggest that both SPS and SZC reduced serum potassium levels over a 48-hour period. Further cost savings would have been achieved if pharmacy had optimized SZC product selection favoring one 10 gram dose rather than two 5 gram doses. Disclosure: Nothing to disclose.

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TSHP Research & Education Foundation Poster Competition 2021 Winners

RESIDENT/FELLOW/POST-GRADUATE –PGY1 Evaluation of the use of Leapfrog’s gold standard medication reconciliation audit process at a large quaternary care academic medical center EC Nnyagu, RB Taylor, KS Putney CHI St. Luke’s Health Baylor St. Luke’s Medical Center, Houston, TX Background: Medication history errors at hospital admission and discharge are common and potentially clinically significant. The Leapfrog Medication Reconciliation measure is intended to reflect the quality or accuracy of a hospital’s medication reconciliation (MR) processes using the “gold standard medication history” audit form. At Baylor St. Luke’s Medical Center, MR processes are performed by nursing staff at patient admission. After MR is performed, pharmacists complete the “gold standard medication history” audit form for each sampled patient to identify the values necessary to report on the Leapfrog Medication Reconciliation measure. Objective: To evaluate pharmacist use of Leapfrog’s medication history audit process Method(s): Single-center, retrospective chart review of sixty-one patients admitted between April 1, 2020, and January 31, 2021. Data was analyzed using descriptive statistics. Continuous variables were summarized using mean. Categorical variables were summarized by percentage. Result(s): Among the 50 patients enrolled, 15 and 10 unintentional discrepancies were identified at hospital admission and discharge, respectively. ‘Medication omission’ was the most frequent type of unintentional discrepancy identified. Unintentional discrepancies were more likely to occur in patients admitted to internal medicine (IM) floors, patients receiving care from the IM service as their primary team, and patients 65 years or older. Conclusion(s): Pharmacist led MR processes are necessary at both admission and discharge as unintentional discrepancies are common at both stages of care. MR should be completed for all patients with characteristics associated with unintentional discrepancies. Disclosure(s) :Authors have no disclosures concerning possible financial or personal relationships with commercial entities that may have a direct or indirect interest in the subject matter of this presentation.

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TSHP Research & Education Foundation Poster Competition 2021 Winners

RESIDENT/FELLOW/POST-GRADUATE –PGY1 Implementing AUC Monitoring in a Pharmacist-Managed Vancomycin Dosing Protocol: a Retrospective Cohort Study BL Robinson, CM Robertson, BA Bennie, M Nasiri, RA Forbess, ME Gessner-Wharton, KD Nguyen HCA Houston Healthcare Kingwood, Kingwood, Texas Background: Consensus guidelines on the therapeutic drug monitoring of vancomycin published in 2020 recognize that using the calculated areaunder-the-curve (AUC) to guide dosing is less nephrotoxic than traditional trough-based dosing. Objective: The purpose of this study was to measure the incidence of acute kidney injury (AKI) before and after implementing AUC monitoring in a pharmacist-managed vancomycin protocol. Methods: Patients 18 years and older who received pharmacist-managed vancomycin therapy were selected using pharmacy surveillance software. Patients were identified from two time frames: August through September 2020, prior to the addition of AUC monitoring to the pharmacy’s dosing protocol, and December 2020 through January 2021, after AUC monitoring was implemented. Patients were excluded if they received less than 48 hours of therapy or had unstable renal function or hemodialysis at baseline. The primary outcome measured was the incidence of AKI (increase in SCr ≥0.3 mg/dl or 1.5x baseline). Results: Data was collected for 121 patients per group. AUC monitoring resulted in an insignificant increase in AKI rate, with 14.9% in the troughmonitoring group, and 16.5% in the AUC-monitoring group (p=0.61). Despite this, patients who received AUC monitoring were more likely to be therapeutic at first follow up (33.9% vs 43.2%, p=0.03) and had lower trough levels and total daily doses, with no significant increase in mortality or length of stay. Conclusions: AUC monitoring did not result in an observed decrease in AKI rate, but did result in more patients being therapeutic at first follow-up and reduced total daily doses of vancomycin. Disclosures: BL Robinson is the PGY1 pharmacy resident for HCA Houston Healthcare Kingwood. CM Robertson is a PGY1 internal medicine resident with HCA Houston Healthcare Kingwood. BA Bennie has nothing to disclose. M Nasiri has nothing to disclose. RA Forbess has nothing to disclose. ME Gessner-Wharton has nothing to disclose. KD Nguyen has nothing to disclose.

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TSHP Research & Education Foundation Poster Competition 2021 Winners

STUDENT Medication use evaluation of bamlanivimab at a tertiary, academic medical center CN Ahiarah, ARBurkhard, L Eichinger, E Nguyen, M Patel, ND Parker, DHu Baylor Scott & White, Temple, Texas Background: Due to the rapid spread of COVID-19 and the impact that it has had on the United States healthcare system, methods of preventing COVID-19 related hospital admissions and mitigating the progression of the disease have been a critical area of research. Bamlanivimab was one of the first monoclonal antibodies that received an emergency use authorization (EUA) by the Food and Drug Administration (FDA) for mildly symptomatic COVID patients with the intention of preventing disease progression to hospitalization. Objective: This study aims to evaluate adherence to the FDA EUA Protocol as well as safety and efficacy data of bamlanivimab use within Baylor Scott & White Health system inpatient facilities located in Central Texas. Methods: This study is a multi-center retrospective chart review of adult patients who presented to a Central Texas Baylor Scott & White emergency department and received bamlanivimab between November 19, 2020 and January 06, 2021.The primary outcome was the composite endpoint of incidence of emergency department (ED) visits, inpatient admissions, and death within 30 days of exposure. Results: Bamlanivimab EUA adherence was 87.3%. Approximately 6.8% of patients experienced at least one side effect during or immediately after receiving bamlanivimab. General efficacy data showed that 83.8% of patients did not have a subsequent ED visit, progression to hospitalization, or expire within 30-days after receiving bamlanivimab. Conclusions: A majority of the patients received bamlanivimab in accordance with the FDA EUA. In general, bamlanivimab was safe and efficacious when administered to patients in Central Texas. Disclosure(s): The authors of this presentation have no disclosures concerning possible financial or personal relationships with commercial entities that may have direct or indirect interest in the subject matter of this presentation.

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Abbreviated New Drug Application (ANDA) Approvals This report includes original ANDA approvals (applications for generic drug) during the selected month(s) Source: Drugs@FDA-Approved Drugs, https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm; July 1 - July 26th; Accessed on July 27th, 2021.

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Download Drugs@FDA Express for free

*Visit the FDA US Food & Drug Administraiton website for additional disclaimers

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Do Not Crush List The List of Oral Dosage Forms That Should Not Be Crushed, commonly referred to as the "Do Not Crush" list, contains medications that should not be crushed because of their special pharmaceutical formulations or characteristics, such as oral dosage forms that are sustained-release in nature. Source: Institute of Safe Medication Practices (ISMP); https://www.ismp.org/; Accessed on July 27th, 2021.

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*View C-Z at https://www.ismp.org/recommendations/do-not-crush. This list is adapted by ISMP with permission from Echaiz, T. A. (Ed.).Oral Dosage Forms That Should Not Be Crushed 2021 [wall chart]. St. Louis, MO: Thomas Land Publishers, Inc. Copyright (C) 2021 Thomas Land Publishers

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