North Carolina Pharmacist Volume 101 Number 4

North Carolina Pharmacist Volume 101 Number 4 Fall 2020

Advancing Pharmacy. Improving Health.

Happy Holidays

See Inside: A Message from the incoming President 2020 Awards Convention Sponsors 50 Plus Club Official Journal of the North Carolina Association of Pharmacists ncpharmacists.org

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

www.ncpharmacists.org EDITOR-IN-CHIEF Tina Thornhill LAYOUT/DESIGN Rhonda Horner-Davis

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

North Carolina Pharmacist Volume 101 Number 4

Fall 2020

Inside • From the President .....................................................................................3 • A message from the NCAP incoming President ........................................................4 • 2020 Awards ..........................................................................................................5 • Our Convention Sponsors .....................................................................................17 • 50 Plus Club .........................................................................................................19 • Rite of Roses .........................................................................................................20

BOARD OF DIRECTORS

• Antimicrobial Support Network Pilot Protocol ......................................................22

EXECUTIVE DIRECTOR Penny Shelton

• New Drug Update .................................................................................................30

PRESIDENT Dave Phillips PRESIDENT-ELECT Beth Mills PAST PRESIDENT Debra Kemp TREASURER Thomas D’Andrea

Click Here to Keep in Touch North Carolina Pharmacist is supported in part by: • WellCare ................................................................................................4

SECRETARY Matthew Kelm

• EPIC Pharmacies Inc .........................................................................16

BOARD MEMBERS

• Pharmacy Quality Commitment .......................................................19

Brianna Berish Courtney Bradley Shannon Brown Ouita Gatton Ryan Mills Holly Nunn Ann Marie Nye Vinay Patel Jennifer Wilson

• Pharmacy Technician Certification Board .......................................21

North Carolina Pharmacist (ISSN 0528-1725) is the official journal of the North Carolina Association of Pharmacists. An electronic version is published quarterly. The journal is provided to NCAP members through allocation of annual dues. Opinions expressed in North Carolina Pharmacist are not necessarily official positions or policies of the Association.

Publication of an advertisement does not represent an endorsement.

Nothing in this publication may be reproduced in any manner, either whole or in part, without specific written permission of the publisher.

• NCAP Career Center .........................................................................23 • Pharmacists Mutual Companies .......................................................30 • VUCA ...................................................................................................34 • Your Community Health Plan ...........................................................35 ADVERTISING For rates and deadline information, please contact Rhonda Horner-Davis at rhonda@ncpharmacists.org

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

Hasta la vista, 2020!

“Said in the best Terminator voice possible”

2020 has been a memorable and historic year. Despite the challenges and chaos, I hope when we look back as an association, we can remember the successes and not just the hardships. It has been an honor to serve as the President of NCAP for the past year, and I am proud of what NCAP has accomplished and the direction the association is headed. As we enter 2021, be on the lookout for the 2020 Annual Report summarizing all our achievements.

dedication and the time they commit to NCAP. It really made my job as President stressless and “easy.” I also want to thank

Lastly, I want to thank you, the members. Without your support, nothing that NCAP does would be possible.

I know the association will be in good hands with Beth Mills taking over as President in 2021, and I look forward to continuing serving NCAP as Past-President and Chairperson next year.

While I hope you took the opportunity to make 2020 your year and year for change, I think we are all also excited to see it end.

Cheers to 2021!

“And now let us welcome the new year, full of things that never were.”

— Rainer Maria Rilke I want to thank Executive Direc- Past-President and Chairperson tor Penny Shelton, the staff, and Debra Kemp and Treasurer Tom Happy New Year, the Board of Directors for their D’Andrea for their mentorship Dave and years of service to NCAP. Page 3

Click here for an important message from the incoming NCAP President

Dr. Beth Mills, PharmD, CPP, BCACP, CDE

We’re Going Beyond Healthcare.

At WellCare, we’re working every day to improve quality of care and lower costs for Medicaid members while building stronger, healthier communities.

We go beyond healthcare. We work to address the issues affecting the health of our members and connect them to the right care and services when they need them most.

Learn more at www.wellcare.com

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2020 Annual Convention Was A Success!

Our first all-virtual annual convention was very successful. The event ran from October 29th through November 6th, and included 30+ hours of programming. The extended format and flexible hours enabled over 400 registrants to attend the event. Convention registrants now have access to all the recordings, in case you were unable to attend some of the live sessions. The NCAP staff extends a special thank you to our Convention Planning Committee, including the Co-Chairs, Matthew Kelm and Dustin Wilson, all of whom were instrumental in developing the programming, securing the speakers and helping with many of the behind the scenes logistics. NCAP President, David Phillips, had this to say about the event. “The overall experience as an attendee was incredible. The setup, utilizing the new LMS and Zoom, was well organized, and although virtual, it still provided an intimate environment that allowed attendees to engage with the speakers. Thank you to the NCAP staff, moderators, speakers and sponsors for such an enjoyable and valuable experience!

Lucky Winners of the Convention Prizes Thank you for your participation!

Deb Hewitt

Julia Clements $150 Gifts for Good e-gift card

$75 Gifts-for-Good e-gift card

Ritesh Patel

Elizabeth Locklear $200 Gifts for Good e-gift card

$75 Gifts-for-Good e-gift card

Bri Berish

Kimberly Mason

$75 Gifts-for-Good e-gift card

Yeti Beach Tote

Shane Bentley $100 Gifts for Good e-gift card

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Showcasing Excellence in Pharmacy Practice

2020 Awards

Dale Jones Memorial Award for Excellence in Geriatrics This prestigious award is presented annually, by the Chronic Care Practice Academy, to an individual who has excelled in care of older adults and who represents, as Dale Jones did, strong community service, a personal commitment to ongoing professional development and support of the state pharmacy association.

NCAP extends its congratulations to this year’s recipient

Dr. Holly Nunn, PharmD

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The Chronic Care Pharmacist of the Year Award Presented to a pharmacist with immense moral character, good citizenship, and high professional ideals, who has made a significant contribution to chronic care pharmacy. This contribution shall have been in the form of sustained exemplary service or an outstanding single achievement

NCAP extends its congratulations to this year’s recipient Dr. Heather Eaton-Erskine, PharmD

The Health-Systems Pharmacist of the Year Award Presented to a pharmacist with immense moral character, good citizenship, and high professional ideals, who has made a significant contribution to health-systems pharmacy. This contribution shall have been in the form of sustained exemplary service or an outstanding single achievement

NCAP extends its congratulations to this year’s recipient Dr. Nita Johnston, PharmD

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Ambulatory Care Pharmacist of the Year Award Presented to a pharmacist with immense moral character, good citizenship, and high professional ideals, who has made a significant contribution to ambulatory care pharmacy. This contribution shall have been in the form of sustained exemplary service or an outstanding single achievement NCAP extends its congratulations to this year’s recipient

Dr. Debra Kemp, PharmD, BCPS, BCACP

Community Care Pharmacist of the Year Award The Community Care Pharmacist of the Year Award is presented to a pharmacist with immense moral character, good citizenship, and high professional ideals, who has made a significant contribution to community care pharmacy. This contribution shall have been in the form of sustained exemplary service or an outstanding single achievement NCAP extends its congratulations to this year’s recipient Dr. Ashley Duggins, PharmD

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ASHP Leadership Award

The NCAP Health-System Practice Academy Chair serves as our state’s official affiliate for the American Society of Health-System Pharmacists. Each year ASHP recognizes the dedication, leadership and volunteer service of the NCAP Health-System Practice Academy Chair.

NCAP extends its congratulations to this year’s recipient Dr. Ryan Mills, PharmD, MBA, MHA, BCPS, CSP

Bowl of Hygeia Award Established in 1958, the Bowl of Hygeia Award, sponsored by NASPA, recognizes pharmacists who possess outstanding records of civic leadership in their communities and encourages pharmacists to take active roles in their communities and the profession. The Bowl of Hygeia is the most widely recognized international symbol for the pharmacy profession and considered one of the profession’s most prestigious awards. Each year NCAP presents the Bowl of Hygeia Award to a pharmacist who has compiled a record of outstanding service to his/her community and profession.

NCAP extends its congratulations to this year’s recipient Dr. Amina Abubakar, PharmD, AAHIVP

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Distinguished Young Pharmacist Award Sponsored by Pharmacists Mutual Companies The Distinguished Young Pharmacist award was created in 1987 to encourage newer pharmacists to become involved in association activities and community service.

This prestigious national award recognizes a pharmacist, in the first decade of their career, in each state, for individual excellence, leadership, and outstanding contributions to the profession of pharmacy.

NCAP extends its congratulations to this year’s recipient Dr. Courtney Bradley, PharmD, BCACP

The Don Blanton Award Sponsored by the North Carolina Association of Pharmacists was established by Charlie Blanton in memory of his father, Don Blanton, who served as NCPhA President in 1957-58. Today, NCAP continues the prestige and tradition of this award by bestowing upon the pharmacist who has contributed the most to the advancement of pharmacy in North Carolina during the past year.

NCAP extends its congratulations to this year’s recipient

Dr. Todd Jackson, PharmD

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The Excellence in Innovation Award Sponsored by Upsher-Smith Laboratories and coordinated by the National Alliance of State Pharmacy Associations, was introduced in 1993 as a way to honor innovative and proactive approaches to enhanced patient care.

This national award is presented to a pharmacist in each state for demonstrating significant innovation, which results in improved patient care, in their respective pharmacy practice.

NCAP extends its congratulations to this year’s recipients

Dr. Franklin Roye, PharmD

Dr. Roye and Dr. Vassie’s collaboration has brought IndyCare to Hillsborough, and they are changing community pharmacy and urgent/walk-in clinic care in exciting ways. IndyCare’s services are designed to meet natural gaps in care by simplifying acute care, offering walk-in diagnostics, screenings, and retail labs, and assisting in chronic care management, medication adherence, and transitional management, and more. Healthcare is delivered through walk-in, drive-up, telehealth, and in-home solutions. IndyCare also provides local solutions such as employer health, school and sports medicine, aging in place, and in-home health assessments. Drs. Roye and Vassie’s commitment to providing healthcare services to the community they serve is evident. They deliver cutting edge care in a way that is accessible to all.

Dr. Gregory Vassie, PharmD

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NCAP Legislative Champion Award This award recognizes an individual who has made far-reaching, sustained contributions, in advancing the profession of pharmacy through legislation.

NCAP extends its congratulations to this year’s recipient Representative Wayne Sasser, is a pharmacist, that has worked tirelessly alongside NCAP, to bring greater awareness of the many contributions that pharmacists provide in the care of North Carolina citizens. The past two years he has been instrumental in helping build support, for our profession’s legislative issues, among both republicans and democrats, and in the NC House and Senate.

Representative Wayne Sasser, RPh

NCAP President’s Award The President’s Award is presented each year to the President of NCAP to show our appreciation for the sacrifices they make to serve our profession at the highest level. The award has traditionally been a clock to help forever mark the time of their service.

NCAP extends its congratulations to this year’s recipient

Dr. David Phillips, PharmD, BCPS

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The NCPA and McKesson Leadership Awards The National Community Pharmacists Association Leadership Award, sponsored by NCPA and coordinated by the National Alliance of State Pharmacy Associations (NASPA) and the McKesson Leadership Award, sponsored by McKesson, are both presented each year to the state pharmacy association’s President-elect. These awards recognize the recipient for their leadership and dedication to the profession.

NCAP extends its congratulations to this year’s recipient Dr. Beth Mills, PharmD, CPP, BCACP, CDE

The President’s Service Award It has been an NCAP tradition, that each year the outgoing NCAP President may choose to recognize one to three members who really stood out in how they helped NCAP during the year of their presidency. This year, President David Phillips has opted to recognize three individuals with the President’s Service Award.

Dr. Taylor has been instrumental in recruiting, coordinating\and facilitating the work of three different groups of public health students from Campbell University to work on public health resources for the Association related to COVID testing, diabetes prevention, and tobacco cessation.

NCAP extends its congratulations to this year’s recipient Dr. William Taylor, PharmD

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The President’s Service Award Dr. Holmes is being recognized for volunteering to serve and lead our E-Learning Special Project Team for the past three years. Prior to the establishment of our e-learning team, NCAP had very few online continuing education programs, but today, due to her coordinating efforts, the Association has a strong line up of on-demand and live stream programming.

NCAP extends its congratulations to this year’s recipient

Dr. Amy Holmes, PharmD, BCPPS

The President’s Service Award

Dr. Wilson graciously gave an extra year of service on the Board of Directors in 2020 to serve as the first chairperson for the Ambulatory Care Practice Academy. She is being recognized for taking on the responsibility for coordinating the successful establishment of this new practice academy for NCAP. NCAP extends its congratulations to this year’s recipient

Dr. Jenn Wilson, PharmD

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NCAP Student Pharmacist of the Year This award recognizes a student pharmacist for their outstanding service to the profession through their volunteer involvement with the North Carolina Association of Pharmacists.

Peter’s work on NCAP’s 2020 Legislative Week proved invaluable. He not only promoted Legislative Week, but he was also instrumental in building the web pages and monitoring changes to ensure our members had the most accurate and up to date information. Peter also collaborated with Anita Yang (SPF Chair) to promote and engage students in Legislative Week. In addition to his internship, he has independently taken an interest in working more closely with the Student Pharmacist Forum to drive student participation and membership into the Association.

Peter Triggiani PharmD Candidate, Class of 2022

NCAP Student Pharmacist of the Year This award recognizes a student pharmacist for their outstanding service to the profession through their volunteer involvement with the North Carolina Association of Pharmacists.

Anita is being recognized as one of the most active student pharmacists in helping with NCAP activities during the year, for example, collaborating with Peter Triggiani to promote and organize student participation and involvement for NCAP’s 2020 Legislative Week. Anita’s work this year has proven instrumental in helping reorganize the Student Pharmacist Forum (SPF) and positioning to provide meaningful contributions to the Association’s mission and vision.

Anita Yang PharmD Candidate, Class of 2021

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NCAP Technician of the Year Presented to a technician practicing in North Carolina who has demonstrated: an ongoing ( > 5 years) dedication to their role as a pharmacy technician; exemplary service and compassion in the care of patients; outstanding support to their co-workers; and a commitment to the advancement of technician professional development.

NCAP extends its congratulations to this year’s recipient.

Jennifer Auman, CPhT

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50 Plus Club

Members Celebrating Fifty Years as a Licensed Pharmacist

Robert Myron Cheskis William Plummer Pitts Pamela McDaniel Brothers John Robert Busbee Carl Thomas Dagenhart Steven Richard Moore William Henry Burch Thank you for your outstanding years of service!

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Rite of Roses Jerry Brady Kennedy  August 7, 1944 - October 9th, 2019

William (Bill) Pickard  June 30, 1953 - August 24th, 2020

The Rite of Roses memorializes those NCAP members who have died since last year’s Convention to honor their lives and their service as pharmacists. The red roses represent reverence while the candles glow to illuminate the members commitment to their profession with devotion to their patients and service to their community.

These individuals were beacons of light and left a legacy built upon service, care, and compassion, and the individuals they mentored will continue to honor their memory through everyday actions of caring for patients, their communities and their profession.

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Antimicrobial Support Network Pilot Protocol: Automatic intravenous Ceftriaxone vs oral Cefpodoxime in Uncomplicated Community-Acquired Pneumonia Dr. Randall Moore Dr. Jennifer Onsrud Dr. Jason Ray

Introduction Community-acquired pneumonia (CAP) is one of the most common infectious diseases worldwide and causes roughly 150,000 hospitalizations each year in the U.S. with the most common causative pathogens including Streptococcus pneumonia, Haemophilus influenzae and Mycoplasma pneumoniae.1 Patients diagnosed with CAP and treated in the inpatient setting typically receive intravenous (IV) antibiotics for initial empiric therapy. The Infectious Disease Society of America gives a strong recommendation for transitioning patients from IV to oral (PO) therapy if they are hemodynamically stable, improving clinically, and can

tolerate PO therapy.2 There is sufficient evidence to suggest a benefit of the early conversion of IV therapy for uncomplicated CAP in a select patient population. Athanassa et al. published a large meta-analysis that included six randomized controlled trials evaluating early switch therapy in patients with moderate to severe CAP. They found no difference in treatment success (OR 0.76; 95% CI 0.36-1.59), no difference in mortality (OR 0.81; 95% CI 0.49-1.33), and decreased length of stay in those with the early transition to PO antibiotic therapy (95% CI -5.22 to -1.65).3 Several clinical trials show the efficacy of cefpodoxime in uncomplicated CAP patients compared to a course of ceftriPage 24

axone.4,5,6 A study published in the Journal of Clinical Outcomes evaluated the use of PO cefpodoxime 200mg twice a day compared to IV ceftriaxone 1 gram daily for a 7-14 day treatment of CAP. The researchers found a similar rate of clinical cure between the two treatment arms with more adverse events reported in the IV ceftriaxone group. In addition, early conversion to PO therapy can expedite patient discharge from the hospital and result in a decrease in overall healthcare cost.5 Patients that reached clinical stability in these studies had a less than a 1% chance of deteriorating and requiring escalation in care.7 Currently Atrium Health (AH) has a pharmacist driven automatic IV to PO protocol that

includes antibiotics such as azithromycin and levofloxacin. AH also has an established Antimicrobial Support Network (ASN) that oversees the utilization of antibiotic therapy. These pharmacists work closely with physicians to ensure patients receive adequate antibiotics with appropriate duration and routinely convert patients who are clinically stable from IV to PO therapy. Ceftriaxone and azithromycin are the recommended empiric antibiotics in Atrium Health’s CAP Powerplan. While azithromycin has a direct PO equivalent, no direct conversion exists for ceftriaxone. As an organization, AH has noted a steady increase in ceftriaxone’s overall utilization; this is thought to be due to the decreased use of fluoroquinolones. The goal of this pilot protocol was to determine if an ASN pharmacist driven protocol for early conversion of ceftriaxone to cefpodoxime has any effect on length of stay, total antibiotic duration, or 30-day readmissions.

Methods

This research was an IRB exempt, observational, quality improvement project performed at Atrium Health Cabarrus (AHC), a community teaching hospital with 457 inpatient beds. This pilot took place from January 2020 to March 2020. ASN pharmacists identified patients through a report of patients prescribed ceftriaxone at AHC. They intervened on patients who had received at least two days of ceftriaxone empirically

for uncomplicated CAP. If the patient met inclusion into the pilot, they were converted from ceftriaxone to cefpodoxime with an automatic discontinuation of therapy after 7 total days of antibiotics. Providers caring for included patients were notified of their patient’s inclusion in the protocol via a secure electronic notification and updated on the change to their treatment course.

Inclusion into the cohort was initially based on the patient meeting criteria of AH’s IV to PO protocol (Appendix A). Additionally, patients must have received at least 48 hours of ceftriaxone therapy for empiric treatment of CAP. Patients were excluded if they had concurrent infections that required additional antibiotics, complicated CAP infections (bacteremia, abscess, empyema), or inadequate oxygenation on room air or baseline oxygen requirements.

A list of historical patients treated with ceftriaxone for uncomplicated CAP in January 2019 through March 2019 was generated. Alphabetically by last name, the same number of historical patients were used as a comparator group to the protocolized patients. These patients were not systematically matched.

The primary outcome was early conversion to PO antibiotics defined as a transition on day 2 through 4 of IV therapy. Secondary outcomes included length of stay (time from admission to time of discharge), total duration of antibiotic therapy, adverse events related to IV therapy, and Page 25

30-day readmission.

Student’s t-test and the Chisquare test were used to compare continuous and categorical variables, respectively. A twotailed p-value of <0.05 denotes statistical significance. Baseline characteristics and outcomes were presented as means and percentages. An a priori sample size calculation determined at least 60 patients in each group would be needed to find a difference of 20% for the primary outcome.

Results

From January 12th through March 31st, 2020 a total of 126 patients were enrolled in the pilot protocol with 63 patients stratified to the historical group and 63 patients in the protocol group. Baseline characteristics were similar between the two groups in terms of age, Pneumonia Severity Index (PSI), positive Respiratory Pathogen Panel, comorbidities, and race. The only statistical difference between the groups was in gender, with 34 males in the interventional group and 23 in the historical group, p-value = 0.048. Patient selection and baseline characteristics are detailed in Figure 1.

The primary outcome, conversion to cefpodoxime on days 2 through 4 of ceftriaxone therapy, occurred more frequently in the ASN group 55 patients (90.2%) vs 41 patients (66.1%), p-value = 0.003. There was a non-statistically significant reduction in the total duration of antibiotic therapy by roughly half a day, (7.13 vs 7.9), p-value = 0.14.

More patients in the ASN group received seven days or less of antibiotics 53 patients (84%) vs 35 patients (55%), p-value = <0.001. Average time to PO conversion was 2.9 days in the protocol group and 4.0 days in the historical group, p-value =<0.001. Length of hospital stay was not different between groups (4.7 days vs. 4.5 days), p-value=0.55. There were eight patients in the protocol group who were readmitted within 30 days and seven in the historical group, p value=0.71. There were no statistically significant differences in reported adverse events between the groups (9 vs 7), p-value = 0.65. One patient in the ASN group was converted back to IV therapy based on provider discretion. Results are listed in Figure 2.

A survey was created for providers to obtain feedback on the conversion protocol. Of those who completed the survey, 100% of providers responded in favor of continuation of the protocol. It was also observed that in comparison from Quarter 1 2019 to Quarter 1 2020, the overall utilization of ceftriaxone was reduced by 13%.

Discussion

This pilot protocol demonstrated that objective clinical criteria can be used to convert patients from IV to PO therapy to effectively limit the duration of IV therapy, conserve IV medications, and follow current guidelines. There are several strengths of this pilot that are worth mentioning. The primary

outcome for this project was an adequately powered sample size, ensuring that the statistical significance was not a chance finding. The patient characteristics in our pilot were homogeneous in nature, except for different proportions of gender that likely did not have an impact on patient outcomes. Finally, patients were similar in the rates of comorbidities as well as PSI. From 2015 to 2019, there was an increase in our facilityâ&#x20AC;&#x2122;s use of ceftriaxone by 44.5% and since the implementation of this pilot there has been a steady decrease of roughly 13% in the first quarter of 2020. This was a novel stewardship intervention that clinically assessed the transition from IV to PO antibiotic without a direct PO comparison. As part of the Centers for Medicare and Medicaid Services (CMS) recommended elements of antimicrobial stewardship in the hospital setting, tracking, and quality improvement plans should be an ongoing process.9 It is anticipated that the continued utilization of this protocol will further reduce overutilization of ceftriaxone.

There were no statistically significant differences for any of the secondary outcomes. The average length of hospital stay was similar between the two groups at 4.68 vs 4.46 days. Though prior studies show at least a one-day decrease in length of stay following PO transition, we hypothesize that this outcome variable was not statistically lower in our group due to increased comorbidities in our patient population.3,8 Page 26

There was a non-statistically significant decrease in the total duration of antibiotics (7.13 vs 7.9 days), p-value = 0.14. This lower than expected duration was likely secondary to provider-determined duration of therapy upon discharge. Our pilot did reveal a significant decrease in the duration of IV therapy compared to the historical group (2.9 vs 4.0 days), p-value <0.001.

Patients in the protocol group were also more likely to receive the appropriate duration of total antibiotic therapy, with 84% of these patients receiving 7 days or less of antibiotics compared to 55% in the historical group, p-value = <0.001.

Adverse effects related to IV therapy was similar between the two groups (9 vs 7), p-value= 0.65, with the predominant adverse event reported being erythema. One would hypothesize that decreased duration of IV therapy would correlate with a reduction in adverse events.

It is likely that the sample size was not large enough to detect a significant difference for this outcome.

Historically clinical instability is a barrier to converting patients from IV to PO antibiotic therapy.

A study on clinical stability in hospitalized patients with CAP found that the average time to clinical stability was 2 days.7 They defined clinical stability as systolic blood pressure >90mmHg, O2 saturation greater than 90%, ability to take PO medications, and a return to baseline mental status. This pilot had similar objective criteria for the determination of clinical sta-

bility. Similar to the Albirti study, of the 96 patients converted to PO therapy, there was only one instance of clinical deterioration where the provider needed to re-intensify antibiotic therapy.

Also, it is important to note that there were no 30-day readmissions related to recurrent pneumonia that would indicate treatment failure in our patient population.7 Limitations of this pilot include its retrospective, observational design as well as the pilotâ&#x20AC;&#x2122;s relatively small sample size, which is likely responsible for nonsignificant findings in the secondary outcomes. The time consumption of implementing this protocol is a potential barrier for its success moving forward. There is also a potential that patients may have been converted later than they could have initially been due to the protocol only being conducted Monday thru Friday, excluding holidays.

Overall, this project found that a pharmacist driven conversion strategy for CAP is a useful and effective intervention for ASN pharmacists. Conversion protocols help facilitate appropriate and expeditious transition of antibiotic therapy while shortening the length of IV therapy.

Conclusion

This pilot protocol demonstrated the successful use of a stewardship pharmacy driven protocol expanding existing IV to PO conversion criteria to ceftriaxone for uncomplicated CAP. Protocol patients were transitioned to PO therapy in an appropriate

timeframe, and overall ceftriaxone utilization was reduced.

Though the protocol did not reveal a significant reduction in length of stay, protocol continuation was supported by positive provider feedback.

References

1. Wunderink RG, Waterer GW. Community-Acquired Pneumonia. N Engl J Med 2014; 370:543-551 DOI: 10.1056/ NEJMcp1214869 2. Mandell LA, Wunderink RG, Anzueto A, et al. Infectious Diseases Society of America/ American Thoracic Society consensus guidelines on the management of community-acquired pneumonia in adults. Clin Infect Dis. 2007;44 Suppl 2:S27-72.

3. Athanassa Z, Makris G, Dimopoulos G, Falagas ME. Early switch to oral treatment in patients with moderate to severe community-acquired pneumonia: a meta-analysis.

Drugs. 2008;68(17):2469-81.

4. Bittner MJ, Toney JF, Eleftheriou PD, Ribner BS. Randomized, double-blinded comparison of oral cefpodoxime proxetil and parenteral ceftriaxone in hospitalized adults with community-acquired pneumonia. J Clin Outcomes Manage 1999;6(3):38â&#x20AC;&#x201C;45 5. Hendrickson JR, North DS. Pharmacoeconomic benefit of antibiotic step-down therapy: converting patients from intravenous ceftriaxone to oral cefpodoxime proxetil. Ann Pharmacother.

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6.

7.

8.

9.

1995;29(6):561-5.

Zuck P, Rio Y, Ichou F. Efficacy and tolerance of cefpodoxime proxetil compared with ceftriaxone in vulnerable patients with bronchopneumonia. J Antimicrob Chemother.

1990;26 Suppl E:71-7.

Aliberti S, Peyrani P, Filardo G, et al. Association between time to clinical stability and outcomes after discharge in hospitalized patients with community-acquired pneumonia. Chest.

2011;140(2):482-488.

Fine MJ, Stone RA, Lave JR, et al. Implementation of an evidence-based guideline to reduce duration of intravenous antibiotic therapy and length of stay for patients hospitalized with community-acquired pneumonia: a randomized controlled trial.

Am J Med. 2003;115(5):34351.

CDC. Core Elements of Hospital Antibiotic Stewardship Programs. Atlanta, GA: US Department of Health and Human Services, CDC; 2019.

Available at https://www. cdc.gov/antibiotic-use/ core-elements/hospital.html.

Authors:

Randall Moore, PharmD, MSCR. PGY-1 Clinical Pharmacist E-mail address: Randall.

Moore@atriumhealth.org. (Corresponding); Jennifer Onsrud, PharmD, BCPS, MSCR. Clinical pharmacist team lead, Antimicrobial support network. Jason Ray, PharmD, BCPS. Clinical staff pharmacist, Antimicrobial support network

Appendix A - Atrium Health IV to PO protocol I.

II.

III.

IV.

Inclusion Criteria for IV to PO Conversion a. Patients ≥ 18 years old located in inpatient adult care areas. b. Patient has received ≥ 48 hours of an intravenous medication approved for interchange (see section III for approved medications).

Exclusion Criteria for IV to PO Conversion a. General exclusion criteria i. Order status 1. Do Not Substitute 2. PRN 3. Continuous infusion proton pump inhibitor 4. Chemotherapy pre/post-medication order set 5. Not currently on other scheduled oral medications in ICU setting ii. Dietary status 1. Not tolerating oral /enteral diet 2. NPO Status 3. Administration via J-Tube 4. Tube feeds not at goal rate 5. Continuous NG suctioning iii. GI status 1. Emesis in last 48 hours 2. Active GI bleed 3. Patient is receiving continuous tube feeds (for levothyroxine, fluoroquinolones and doxycycline only) 4. Ileus 5. Diarrhea (>5 bowel movements per day OR greater than 1 liter of stool output) 6. Residual output greater than 500mL 7. Portion of the intestines removed (i.e. colostomy, jejunostomy, Whipple procedure) 8. Documented malabsorption syndrome b. Additional exclusion criteria for antimicrobials i. No clinical improvement in last 24 hours: 1. Temperature ≥100.4°F or ≤96.8°F 2. WBC not returning to normal ii. Patient is receiving scheduled sucralfate (for fluoroquinolones and doxycycline only) iii. Antimicrobial(s) used for the treatment of: 1. Endocarditis 2. Meningitis or other CNS infection 3. Osteomyelitis 4. Bacteremia or positive blood cultures within last 14 days 5. Neutropenia (ANC <1000) 6. Fungemia 7. Active (or acute concern for) Clostridium Difficile infection Medications approved for IV to PO conversion a. Atrium Health System P&T approved medications for IV to PO conversion include: i. Azithromycin ii. Ciprofloxacin iii. Levofloxacin iv. Doxycycline v. Fluconazole vi. Linezolid vii. Metronidazole viii. Famotidine ix. Pantoprazole x. Levetiracetam xi. Lacosamide xii. Levothyroxine Pharmacist Roles and Responsibilities a. Daily monitoring i. Pharmacy will review a system approved IV/PO report and patient information daily to determine eligibility for IV to PO conversion. Pharmacy may communicate with nursing and/or physician if necessary, to clarify eligibility (Report Functionality Document). ii. Pharmacy will evaluate the patient to determine if any exclusion criteria for conversion are met. The pharmacist will initiate an electronic intervention for documentation to determine if conversion is optimal. iii. When no exclusion criteria are met, the pharmacist will follow the standard process for converting medication from IV to PO per P&T approved protocol.

Providers have the authority to override the IV to PO conversion by indicating in the order comments of the ordered medication.

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Figure 1. Baseline characteristics and patient selection ASN (N=63)

Hx (N=63)

P-value

Male sex, n (%)

34 (53.9)

23 (36.5)

0.048*

Respiratory Pathogen Panel positive, n (%)

14 (22.2)

14 (22.2)

0.61

Age, years, median

Pneumonia Severity Index (PSI) score, median Comorbidities, n (%)

66

79.4

64

76.2

0.53

0.51

Diabetes Mellitus

18 (28.5)

19 (30.1)

0.84

Kidney Disease

5 (7.9)

6 (9.5)

0.94

Respiratory Disease

History of Malignancy Liver Disease Smoker HIV

Race

White Black

14 (11.1) 2 (3.1)

1 (1.5)

16 (25.4) 1 (1.5)

54 (85.7) 8 (12.7)

*P-value <0.05 considered statistically significant

18 (28.5) 2 (3.1)

2 (3.1)

21 (33.3) 1 (1.5)

46 (73.0) 15 (23.8)

0.48 0.87

0.49

0.32 0.22 0.09

0.10

Figure 2. Primary and secondary outcomes ASN (N=63)

Historical (N=63)

P-value

Early PO conversion [n (%)]

55 (90.2)

41 (66.1)

0.003*

Average length of hospital stay (days)

4.68

4.46

0.55

Patient who received â&#x2030;¤7 days of therapy (%)

53 (84.1)

35 (55.5)

<0.001*

Primary outcome

Secondary outcomes

Total duration of antibiotic therapy (days) 30-day readmission

Adverse events related to IV therapy n (%) Pain

Erythema

Re-escalation of IV therapy

7.13 (5.0-10.0) 8 (12.7)

9 (14.3) 2 7

7.9 (4.0 â&#x20AC;&#x201C; 14.0) 7 (11.1)

7 (11.1) 1 6

1

0

*P-value <0.05 considered statistically significant (NS = not significant) Page 29

0.14 0.71

0.65 NS NS

NS

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New Drug

By: Emily Woodfield, PharmD Candidate Generic Name Opicapone

Opicapone is an oral medication best taken on an empty stomach. When taken after a moderate fat/ moderate caloric meal, the mean peak plasma concentration can be reduced by up to 62%. The mean overall plasma concentration is reduced by 31%, and the peak time is delayed by four hours. With a peak time of two hours, opicapone has a one to four-hour range of onset. The elimination half-life was found to be between one and two hours.

Brand Name Ongentys®

FDA Approved April 24, 2020

Similar Agents Entacapone (Comtan®) and tolcapone (Tasmar®)

Classification1, 2 Anti-Parkinson Agent, Catechol-O-methyltransferase (COMT) inhibitor Indication1, 2 Approved Uses: Used as adjunctive therapy with levodopa/carbidopa in patients with Parkinson disease experiencing “off” episodes.

Unlabeled Uses: None

Pharmacology1-4 Opicapone is a long-acting, selective, and reversible inhibitor of COMT. COMT naturally metabolizes levodopa, when introduced into the body, to the inactive metabolite 3-methoxy-4-hydroxy-L-phenylalanine. By inhibiting COMT, peripherally, more levodopa can circulate and cross the blood-brain barrier.

Pharmacokinetics1 Absorption

Distribution Independent of concentration, opicapone is largely bound to plasma proteins (>99%).

Metabolism Opicapone is not an inhibitor or inducer of any major CYP isoenzymes. The drug is primarily metabolized via sulphation. Lesser metabolic pathways include glucuronidation, methylation (by COMT), reduction, and glutathione conjugation.

Elimination The mean elimination half-life is 1-2 hours. Opicapone, is primarily eliminated from the body through feces (70%), where 22% of the drug is found unchanged. Opicapone is also partially eliminated through respirations (20%) and renally (5%, with approximately 1% as unchanged in the urine).

Clinical Efficacy3, 4 A randomized, multi-center, double-blind, placebo-controlled trial was conducted to determine the efficacy of opicapone in conjunction with levodopa/ dopa decarboxylase inhibitor (DDCI) therapy, fol-

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lowed by a 1-year open-label phase where all patients received opicapone in twelve different countries across Europe, Africa, Australia, South America, and Asia. The primary endpoint was a change from baseline in absolute off-time versus placebo in the double-blind phase; the open-label phase was focused on maintaining treatment off-time effect.

Secondary outcomes included change in the Parkinson’s Disease Sleep Scale (PDSS), 39-item Parkinson’s Disease Questionnaire (PDQ-39), the Non-Motor Symptoms Scale (NMSS), and the clinician’s and patient’s Clinical Global Impression of Change (CGI-C and PGI-C, respectively). Patients that were included had a diagnosis of Parkinson’s disease for at least three years, Hoehn-Yahr stage of one to three (mild unilateral disease to mild-to-moderate bilateral disease), and at least a one-year history of clinical improvement with levodopa or levodopa/DDCI. These patients previously had to receive a stable regimen of levodopa three to eight times daily and have signs of end-of-dose deterioration for at least four weeks before screening. They were required to keep meticulous diaries that tracked if their symptoms were considered to be either “off, on with troublesome dyskinesia, on with non-troublesome dyskinesia, on without dyskinesia, or asleep” for every 30-minute period for three days before each visit.

A total of 427 patients, primarily white males aged 60-65, were randomized in a 1:1:1 fashion, 144 receiving levodopa/DDCI plus placebo, 129 receiving levodopa/DDCI plus 25mg of opicapone, and 154 receiving levodopa/DDCI plus 50mg of opicapone.

Of those patients, 130, 118, and 128 completed the double-blind period, respectively. Of the 367 who entered the one-year open-label period, 286 completed the study. It was noted that in both phases of the study, adverse effects was the primary cause of study withdrawal. Patients who completed the double-blind phase showed a primary outcome of -64.5 minute change in off-time for placebo, -101.7 minute change for 25mg of opicapone, and -118.8 minute change for 50mg of opicapone. This showed a statistically significant difference when 50mg of opicapone was compared to placebo (-54.3[95% CI, -96.2 to -12.4]minutes; p=0.008); however, there was no statistically significant difference in off-time for those taking 25mg of opicapone when compared to placebo (-37.2[95% CI, -80.8 to 6.4]minutes; p=0.11). The secondary endpoints showed a reduction of the PDQ-39 from -2.6 to -4.8, an increase of

PDSS from 2.3 to 5.1, a reduction of NMSS from -2.0 to -5.2, an increase of CGI-C from 3.2 to 3.5, and an increase of PGI-C from 3.2 to 3.5; however, none of these secondary endpoint changes were statistically significant.

Another randomized, double-blind, placebo-controlled and active-controlled trial of opicapone in conjunction with levodopa in patients with Parkinson’s disease with end-of-dose motor fluctuations was conducted to determine if opicapone was superior to placebo via an intention to treat analysis (ITT) and non-inferior to another COMT inhibitor, entacapone, via a per-protocol analysis. The primary endpoint was a change from baseline to the end of the study in absolute off-time. Six hundred patients were analyzed, and 590 of them were randomized in a 1:1:1:1:1 fashion into the following arms: placebo, entacapone 200mg, opicapone 5mg, opicapone 25mg, or opicapone 50mg, with 120, 120, 119, 116, and 115 patients in each treatment arm, respectively.

Patients that were included had a diagnosis of Parkinson’s disease for at least three years, Hoehn-Yahr stage of one to three, and at least a one-year history of clinical improvement with levodopa or levodopa/DDCI. These patients previously had to receive a stable regimen of levodopa three to eight times daily and have signs of end-of-dose deterioration for at least four weeks before screening. Diaries were kept, showing the time patients were experiencing “off or on” symptoms during each 30-minute period of the three days prior to a visit.

Most patients were males with a mean age of 64.

The mean change in off-time was -56.0 minutes (SE 13.4; 95% CI -82.3 to -29.7) for placebo, -96.3 minutes (13.4; 95% CI -122.6 to -70.0) for entacapone 200mg, -91.3 minutes (13.5; 95% CI -117.7 to -64.8) for opicapone 5mg, -85.9 minutes (13.7; 95% CI -112.8 to -59.1) for opicapone 25mg, and -116.8 minutes (14.0; 95% CI -144.2 to -89.4) for opicapone 50mg. It was determined that opicapone 50mg was superior to placebo with a change in baseline of -60.8 minutes (95% CI -97.2 to -24.4; p=0.0015), and non-inferior to entacapone 200mg with a change in baseline of -26.2 minutes (95% CI -63.8 to 11.4; p=0.0051).

Drug Interactions1, 2 Non-selective MAO inhibitors and opicapone inhibit catecholamine metabolism, which may lead to an

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increased risk of arrhythmias, increased heart rate, and changes in blood pressure.

Opicapone was not found to significantly affect the pharmacokinetics of other medications when administered concomitantly including S-warfarin, R-warfarin, or repaglinide. Opicapone did not have significantly different pharmacokinetics when quinidine, acetaminophen, or rasagiline were administered concomitantly. There was no significant difference in the pharmacokinetics with other medications used for the treatment of Parkinson’s disease including: rasagiline, selegiline, pramipexole, ropinirole, or amantadine.

Opicapone was not found to affect the protein binding of warfarin, diazepam, digoxin, or tolbutamide when studied in vitro. It is not an inhibitor or inducer of any major cytochrome P450 enzymes. It is a substrate of P-glycoprotein (MDR1), BCRP, MRP2, OATP1B3, and OATP2B1; however, there is no expected transporter-mediated interaction. Opicapone is not an inhibitor of P-glycoprotein (MDR1), BCRP, OAT1, OAT3, OCT1, OCT2, OATP1B3, BSEP, MATE1, or MATE2-K. Adverse Effects1-4 The most common adverse reaction to opicapone is dyskinesia with about 20% of patients experiencing this effect. Patients may also experience constipation, dry mouth, hallucinations, hypertension, headache, and nausea (1-10%).

Pregnancy and Lactation1, 2 Data collected involving pregnant or lactating women is limited. An animal study performed on rabbits showed that oral administration of opicapone during pregnancy caused an increased incidence of fetal abnormalities at clinically relevant plasma exposures.

A second study was performed on rats and it was found that pregnant rats did not show any adverse effects on embryofetal development at forty times the recommended human dose. Opicapone is always given concomitantly with levodopa/carbidopa, which has shown developmental toxicity in rabbits.

An animal lactation study that was performed on rats showed that levels of opicapone or metabolites in milk were similar to those in maternal plasma. The benefits of infant breastfeeding should be discussed with a physician monitoring the mother’s clinical need for opicapone.

Dosing1, 2 It is dosed as 50mg by mouth once daily at bedtime. It is recommended that food not be eaten for one hour before and at least one hour after taking opicapone. If a dose is missed, the patient should skip the dose, and take the next day at bedtime. This medication does not need to be renally adjusted. It is suggested that in patients with moderate hepatic impairment, Child-Pugh class B, the dose should be reduced to 25mg by mouth once daily at bedtime.

Opicapone is not recommended for use in patients with severe hepatic impairment, Child-Pugh class C. Storage1, 2 It is recommended to store this product in the original bottle; optimally stored at 20-25° C, but may be stored for limited times in 15-30° C.

Dosages and Cost1 This medication comes as an oral 50mg dark blue/ pink capsule, as well as an oral 25mg light blue/ pink capsule. A 30-day supply as Ongentys® 50 mg capsules has a cost of approximately $625. Patient assistance resources are located at https://www. ongentyshcp.com/access/.

Summary/Use in clinical practice1-4 Opicapone is a viable option in combination with levodopa when treating off times for patients with mild to moderate Parkinson’s disease. Patients with Parkinson’s disease may experience end-of-dose motor fluctuations which is due to the short half-life of levodopa. Levodopa is the mainstay of therapy for patients with Parkinson’s disease, and patients typically will need to increase their concentration or frequency of levodopa doses as the disease progresses. With a COMT inhibitor, such as opicapone, it may be possible to down-titrate levodopa doses as the levodopa is not broken down as quickly in the brain and periphery. This effect allows for patients to experience fewer off times and more control of their muscles.

Opicapone should not be used as monotherapy, but it may be considered as a first line COMT inhibitor as it was found to be noninferior to entacapone.

Its once-daily dosing has proven efficacy amongst patients with normal and mild to moderate liver impairment, which would only require a 50% dose reduction from 50mg to 25mg daily. Opicapone is relatively safe with no contribution to hepatic dam-

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age unlike tolcapone. Adverse reactions most common with this medication shown in the two studies were dyskinesia, constipation, hypertension, and insomnia. Be mindful of patients who are taking monoamine oxidase inhibitors, have a pheochromocytoma, or other catecholamine secreting neoplasms, as they will be at an increased risk for catecholamine-induced side effects such as arrhythmias, hypertension, dry mouth, and constipation.

Long-term safety studies should be conducted to determine if this medication can be continued indefinitely in patients presenting with Parkinson’s disease. One prospective cohort study is planned to determine the “Safety and Effectiveness of Opicapone Plus the Standard of Care in Elderly Patients with Parkinson’s Disease.”

References

1. Opicapone [package insert]. San Diego, CA: Neurocrine Biosciences, Inc; 2020.

2. Lexi-Drugs. Lexicomp Online [database online]. Hudson, OH: Lexicomp, Inc. http:// online.lexi.com. Updated 2020. Accessed June 12, 2020.

3. Lees AJ, Ferreira J, Rascol O, et al. Opicapone as adjunct to levodopa therapy in patients with parkinson disease and motor fluctuations: A randomized clinical trial. JAMA Neurology. 2017;74(2):197-206. http://dx.doi. org/10.1001/jamaneurol.2016.4703. doi: 10.1001/jamaneurol.2016.4703.

4. Ferreira JJ, Prof, Lees A, Prof, Rocha J, BSc, Poewe W, Prof, Rascol O, Prof, Soares-daSilva P, Prof. Opicapone as an adjunct to levodopa in patients with parkinson’s disease and end-of-dose motor fluctuations: A randomised, double-blind, controlled trial. Lancet Neurology, The. 2016;15(2):154165. https://www.clinicalkey.es/playcontent/1-s2.0-S1474442215003361. doi: 10.1016/S1474-4422(15)00336-1.

Author: Emily Woodfield is a 2021 PharmD Candidate at the Campbell University College of Pharmacy & Health Sciences. She completed an APPE rotation with Dr. Shelton in June 2020. e_russell0425@email.campbell.edu

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

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