The Journal November/December 2019

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Volume 22

NOVEMBER/DECEMBER 2019 • VOLUME 22 • ISSUE 6

SEE PAGE 49 FOR DETAILS

THE JOURNAL OF THE PHARMACY SOCIETY OF WISCONSIN

RETURN S ERV ICE RE QUES TE D

Issue 6 www.pswi.org

November/December 2019

2019 PSW Annual Meeting Recap

Pediatrics


Supplement www.pswi.org Special Edition 2019

COMING SOON!

Honoring a Legacy


2019

November/December Continuing Education

8

CE for Pharmacists: Pediatric QTc Prolongation: A Review of Risk Factors and Management Strategies

Features

3

UpFront: Thankfulness

Spotlight

42

WPQC Spotlight: Karen Roby, Mount Horeb Pharmacy

44

Pharmacy Leadership Spotlight: Jill Michaud

PSW News

16

ID Corner: Urine Trouble: Optimizing the Management of Pediatric UTIs in the Outpatient Setting

6

I am a Pharmacy Professional and a... Pet Owner

20

WPQC Update: Unique CMR Implementation Strategies: Streu's Pharmacy Expansion of Clinical Services

46

Pharmacists Perception of the Utility of Non-vaccine Injection in Their Practice Revisited Two Years Later

Original Work

Meeting Recap

26

Pharmacist Managed Warfarin Dosing Using Chromogenic Factor X Assay During Direct Thrombin Inhibitor Overlap Therapy

50

2019 PSW Annual Meeting Recap

32

Improving Immunization Rates in Long-Term Care Facilities: A Pilot Study

56

2019 PSW Presidential Address: Maybe Someday - TEDRx

36

Implementation of a System-wide, Telephonic, Pharmacistled Population Health Program: Metformin Dose Optimization

Writing Club

22

Changing Landscapes in Pediatric Food Allergy Prevalence

Pharmacy Reflections

61

The Future...


The Journal of the Pharmacy Society of Wisconsin is a professional publication for original research, review, experience, and opinion articles that link science with contemporary pharmacy practice to improve patient care. Together we can inspire each other to advance our profession with the single purpose of enhancing the lives of our patients.

Pharmacist Editor AMANDA MARGOLIS, PharmD, MS, BCACP Managing Editor & Creative Content Director MEGAN GRANT, mgrant@pswi.org CE Coordinator PATRICIA THORNWELL, PharmD Peer Review Coordinators ANGELA COLELLA, PharmD, BCPS MICHAEL NAGY, PharmD SARAH PEPPARD, PharmD ID Corner Series Coordinator LYNNE FEHRENBACHER, PHARMD, BCPS-AQ ID Precepting Series Coordinator MELISSA THEESFELD, PharmD Open Access Coordinator NICK J FRIEDLANDER, 2020 PharmD Candidate

Editorial Advisory Board LOREN CARRELL, PharmD Clinical Pharmacist/Pharmacist in Charge, Gundersen Health System, La Crosse ANGELA COLELLA, PharmD, BCPS Drug Formulary Specialist, Drug Use Policy Aurora Healthcare, Milwaukee SHABNAM DABIRSHAHSAHEBI, PharmD, MS Drug Information Pharmacist Dean Clinic-Landmark Office, Madison MELISSA HEIM, PharmD, BCCCP Clinical Pharmacist, William S. Middleton Memorial Veterans Hospital, Madison LYNNE FEHRENBACHER, PharmD, BCPS-ID Associate Professor of Pharmacy Practice Concordia University School of Pharmacy, Mequon CATHERINE (KATIE) KUECKER, PharmD PGY2 Ambulatory Care Pharmacy Resident William S. Middleton Memorial Veterans Hospital, Madison LYNNAE MAHANEY, MBA, BS Pharm Director, Pharmacy Accreditation American Society of Health-System Pharmacists

MICHAEL NAGY, PharmD Assistant Professor, Department of Clinical Sciences, Medical College of Wisconsin School of Pharmacy, Milwaukee MIKE OCHOWSKI, RPh, BBA Formulary Pharmacist, Group Health Cooperative of South Central Wisconsin, Madison KHYATI PATEL, PharmD Assistant Professor of Pharmacy Practice Rosalind Franklin University of Medicine and Science College of Pharmacy, North Chicago, IL TRISHA SEYS RANOLA, PharmD, CGP, CDE Clinical Phamacist, William S. Middleton Memorial Veterans Hospital, Madison SARA SMITH-SHULL, PharmD, MBA, BCPS Drug Policy Program, UW Health, Madison DIMMY SOKHAL, PharmD Clinical Pharmacist, Hayat Pharmacy, Milwaukee JULIE THIEL, PharmD, BCCP Clinical Pharmacist Winnebago Mental Health Institute, Winnebago PATRICIA THORNEWELL, PharmD Medical Education and Grants, Exact Sciences Corporation, Madison

NATE MENNINGA, PharmD Clinical Pharmacist, William S. Middleton Memorial Veterans Hospital, Madison MATTHEW WOLF, PharmD, MS Pharmacy Manager SUSIE MORONEY, PharmD, MS Froedtert Hospital, Wauwatosa Regional Scientific Director in Immunology, Novartis, Fitchburg

PSW Executive Board MATTHEW MABIE, RPh Chairman of the Board

RYAN MILLER, PharmD, BCPS Treasurer

MICHAEL GILLARD, PharmD, BCPS President

SARAH SORUM, PharmD Interim Executive Vice President & CEO

MELISSA THEESFELD, PharmD President-Elect

PSW Board KATHERINE HARTKOPF, PharmD, BCACP Region A Director 2019-21

KATE SCHAAFSMA, MBA, MS, PharmD, BCPS Director-at-Large 2018-20

GRETCHEN KUNZE, PharmD, BCPS Region B Director 2018-20

SARAH SCHMIDT, PharmD Director-at-Large 2018-20

ASHLEY HELLERMANN RANKIN, PharmD Region C Director 2019-21

NICOLE SCHREINER, PharmD Director-at-Large 2019-21

JOYLYN MOORE, PharmD Region D Director 2018-20

DEAN ARNESON, PharmD, PhD Dean Concordia University Wisconsin SOP

STEVEN D FINKENBINDER, RPh Region E Director 2019-21

STEVE SWANSON, PhD Dean UW School of Pharmacy

JUSTIN KONKOL, PharmD, BCPS Region F Director 2018-20

GEORGE MACKINNON, PhD, MS, RPh Dean Medical College of Wisconsin SOP

MICHAEL ENDRIES, PharmD, BCPS Director-at-Large 2019-21

TIMOTHY MCGUIRE, PharmD Senior & LTC Section Chair 2019-2020

ARLENE IGLAR, MS, RPh, FASHP Director-at-Large 2017-21

MIRANDA PEEK, CPhT Technician Section President 2019-2020

SCOTT LARSON, PharmD Director-at-Large 2018-20

PSW Staff ELLEN BRUMMEL MEGAN GRANT AMANDA MARGOLIS, PharmD, MS, BCACP ERICA MARTIN HELENE MCDOWELL, MS CHAD NECHVATAL, CPA

RYAN PSYCK KAY SCHELL SARAH SORUM, PharmD KARI TRAPSKIN, PharmD DANIELLE WOMACK, MPH

Send correspondence to: Megan Grant, Pharmacy Society of Wisconsin 701 Heartland Trail, Madison, WI 53717, phone: 608-827-9200,   fax: 608-827-9292, thejournal@pswi.org Authors are encouraged to submit manuscripts to be considered for publication in The Journal. For Author Guidelines, see http://www.pswi.org/Get-Involved/Publish-articles-in-The-Journal Advertising inquiries: Megan Grant, Pharmacy Society of Wisconsin, 701 Heartland Trail, Madison, WI 53717, phone: 608-827-9200, fax: 608-827-9292, mgrant@pswi.org

The Journal of the Pharmacy Society of Wisconsin (ISSN 1098-1853) is the official publication of the Pharmacy Society of Wisconsin. Subscription included in membership dues. Non-member subscription $90 per year. Outside North America, add $60. Single copies $25 ($50 if outside North America). Periodical postage paid at Madison, WI and additional offices. Published bimonthly by the Pharmacy Society of Wisconsin, 701 Heartland Trail, Madison, WI 53717. Postmaster: Send address changes to PSW, 701 Heartland Trail, Madison, WI 53717. Opinions expressed by contributors do not necessarily reflect those of PSW.

2  The The Journal Journal November/December November/December2015 2019 2

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Features

Up Front:

Thankfulness by Amanda Margolis, PharmD, MS, BCACP

T

hankfulness, or “the feeling of being happy or

their volunteer role is double-blinded, peer reviewers often do not

grateful because of something�1 is a common

receive the recognition they deserve. Peer reviewers are also often

sentiment this time of year. We describe

completing the reviews in their spare time when there are other

what we are thankful for at Thanksgiving and

personal development or work tasks that could be completed. But I

throughout the holiday season. I think everyone

can tell you first hand, the process helps to maintain the quality of

has a lot to be thankful for, we often get to spend time with family during this season, we are in a profession full of innovators, and we are privileged to serve and help patients. Similarly, The Journal has thrived during 2019 due to the volunteer efforts of members for which I am thankful. I would like to take this space to describe the impact these volunteers have on JPSW during this season of thankfulness. The authors and contributors to JPSW are the backbone of The Journal. Those who have an idea or a project they want to share and put in the additional time and effort to write knowing their work will be critiqued, often in their spare time! Those individuals are brave and passionate and I am thankful that they are willing to spend family or relaxation time on writing to share their ideas with the members of PSW. Likewise, peer reviewers are the gatekeepers of The Journal. As

www.pswi.org

manuscripts included in The Journal and without the interest and diverse expertise our peer reviewers have, JPSW would not be what it is today! Thank you to all 2019 peer reviewers, you can see the full list of peer review volunteers in Box 1. Another special group of JPSW volunteers is the Editorial Advisory Board. This group takes on a number of roles from wholistic suggestions and monitoring of JPSW, generation of article ideas for our student writers, and are my go-to group when I need a review or an opinion. Many members of the Editorial Advisory Board hold additional roles within JPSW. Our series coordinators, Lynne Fehrenbacher and Melissa Theesfeld, plan and review an article for each issue. Our peer review coordinators and student writing club coordinators, Patti Thornwell, Angela Colella, Michael Nagy, and Sarah Peppard, work closely with student writers and other JPSW contributors to facilitate feedback and quality manuscripts for publication. Nick Friedlander manages November/December 2019

The Journal 3


jpsw.org and open access materials. Lastly, Lynnae Mahaney served as a guest contributing editor for a special themed issue on practice advancement for the July/August issue. Lynnae solicited and reviewed every article that went into that issue! I am also thankful for the staff assistance at PSW. Megan Grant, the Managing Editor & Creative Content Director for PSW and The Journal keeps everything on track and makes everything in JPSW gorgeous! Megan is my right-hand for all things journal related and I could not produce the quality publication we have without her! I am also thankful to Sarah Sorum and Chris Decker for giving me this opportunity. Not only the role of Pharmacist Editor, but also the support and independence they have allowed. Without their support and guidance JPSW would not be open access and we would be unable to support some of our newer initiatives such as the supplement publications of meeting abstracts. Lastly, I am thankful for an engaged readership. The excitement over each issue as well as comments and feedback on the content is what keeps JPSW going. The readership engagement and discussions is what makes writing and editing in the evening worth it and i am grateful for everyone who has participated. Amanda Margolis is the Pharmacist Editor of The Journal of the Pharmacy Society of Wisconsin.

1 Special Practice Advancement Issue 1 Online Green Issue 2 Journal Posters 3 Journal Supplements 4 PSW Meeting Recaps 6 CE Articles 10 Pharmacy Spotlights 39 Articles Reviewed 9 Mentored Peer Reviews 79 Individuals Conducted Peer Reviews

Box 1. 2019 Peer Reviewers Briana Amundson Kasey Arnhoelter Staci Baker Nitish Bangalore Julie Bartell Megan Bauer Maya Beganovic Meghan Belden Kyle Beyer Beth Buckley Loren Carrell Anne Daniels Brook DesRivieres David Dulak Joe Eckart Seth Edwards Diane Erdman Robinson, Erin Michelle Farrell Rebecca Fiore Casey Gallimore

4  The Journal

November/December 2019

Allison Gibble Brianna Glynn-Servedio Marissa Goninen Steve Grapentine David Grinder Dave Hager Stacy Harmon Mickey Hart Melissa Heim Jennifer Hetzel Angie Huang Paul Hutson Shilpa Khot Sarah Klemm Parker Knueppel Josephine Kristiansen Yokes, Kristina Cathy Lea Brittany Lee Molly Lehmann (Obermark) Jennifer Lis

James Lokken Darya Lough Brianna Miller Susie Moroney Jessica Moschea Michael Nagy Steven Orlando Alex Peaslee Mary Frances Picone Marie Pietruszka Rohan Pradhan Marbi Presto Sarah Ray David Reeb Allison Riendeau Kate Schaafsma Julia Schliefelbein-Egan Michael Schmidt Bryant Schobert

Rebecca Schoen Sara Schull Brianna Glynn Servedio Abby Sharpe Jennifer St John Carla Staresinic Aaron Steffenhagen MaryAnn Steiner Frey, Theresa Brian Trinh Meghann Voegeli Elyse Weitzman Cody Wenthur Marleen Wickizer Andrew Wilcox Katie Willenborg Matt Wolf Angela Zivkovic

Thank You! www.pswi.org


The Journal of the Pharmacy Society of Wisconsin 2020 Editorial Plan Editor’s Note: This plan has been developed in collaboration with PSW staff, the Editorial Advisory Board, and reader feedback. Each of the six issues scheduled for publishing in 2020 will have a general theme and submission deadline (Table 1.). The purpose of this is to provide authors an opportunity to plan ahead and contribute based on their expertise. Not every article in these issues will be or needs to be focused on the theme listed. Table 1. The Journal of the Pharmacy Society of Wisconsin 2020 Editorial Plan

Journal Issue

Issue Theme

Submission Deadline

January / February

Theme: Cardiology Series: ID Corner / Precepting Tips I am a Pharmacy Professional and a… Baker

Submission Deadline: October 1, 2019

March / April

Theme: Adherence Series: ID Corner / Precepting Tips I am a Pharmacy Professional and I help the environment

Submission Deadline: Dec 1, 2019

May / June

Theme: Pain Management Series: ID Corner / Precepting Tips I am a Pharmacy Professional and an… Artist

Submission Deadline: Feb 1, 2020

July / August

Theme: Career Development Series: ID Corner / Precepting Tips I am a Pharmacy Professional and an… Athlete

Submission Deadline: April 1, 2020

September / October

Theme: Immunizations and Preventative Health

The JournalSeries: of the Pharmacy of Wisconsin Submission Deadline: June 1, 2020 ID Corner / PreceptingSociety Tips I am a Pharmacy Professional and a… Teacher 2021 Editorial Plan

Theme: The Past and Future of Pharmacy December Series IDwith Corner Precepting Tips Advisory Board, andSubmission Deadline: Augof1,the 2020 Editor’sNovember Note: This/ plan has been developed in collaboration PSW/ staff, the Editorial reader feedback. Each six I ama ageneral Pharmacy Professional and a…deadline Volunteer issues scheduled for publishing in 2021 will have theme and submission (Table 1.). The purpose of this is to provide authors an opportunity to plan ahead and contribute based on their expertise.

Not every article in these issues will be or needs to be focused on the theme listed. Table1. 2.The TheJournal Journalofofthe thePharmacy PharmacySociety Societyofof Wisconsin 2021 Editorial Plan Wisconsin 2021 Editorial Plan Table

Journal Issue

Issue Theme

Submission Deadline

January / February

Theme: Wellness and Nutrition Series: ID Corner / Precepting Tips

Submission Deadline: October 1, 2020

March / April

Theme: Medication Safety and Quality Series: ID Corner / Precepting Tips

Submission Deadline: Dec 1, 2020

May / June

Theme: Geriatrics Series: ID Corner / Precepting Tips

Submission Deadline: Feb 1, 2021

July / August

Theme: Innovations in Technology Series: ID Corner / Precepting Tips

Submission Deadline: April 1, 2021

September / October

Theme: Immunizations and Global Health Series: ID Corner / Precepting Tips

Submission Deadline: June 1, 2021

November / December

Theme: Men’s and Women’s Health Series ID Corner / Precepting Tips

Submission Deadline: Aug 1, 2021


PSW News

I am a Pharmacy Professional and a...

Pet Owner Jan/Feb 2020 Theme: I am a Pharmacy Professional and a...Baker Email your response to mgrant@pswi.org by December 2.

March/April 2020 Theme: I am a Pharmacy Professional and I... Help the Environment Email your response to mgrant@pswi.org by February 1. Responses should be <100 words and include a photo.

6  The Journal

November/December 2019

Julie Asmus PharmD, BCPS Clinical Pharmacist Fort Healthcare Pharmacy

I am not just a pet owner; I am a dog lover! I have had a dog since I was 6 years old and have not been without one since. I currently have four dogs, 3 Brittanys, Petey (12 yo), Levi (7yo), and Rocky (2 yo), and an English Springer Spaniel named Taz (5 yo). Dog sports are my hobby and I compete in various events with my dogs. I love most, watching my dogs do what they were bred to do, hunt birds. It’s a great way to get exercise, keep your dog’s mind active, and meet other dog lovers. Pictures are of the 3 Brittanys, and practicing carting for the Fort Atkinson Christmas parade.

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Patti Thornwell, PharmD Medical Education and Grants Exact Scinences Corporation, Madison

I started pharmacy school a dog lover and left a cat owner. I adopted Bucky from the Dane County Humane Society in 2009 halfway through my fourthyear rotations. He was found outside the athletic ticket office and sponsored by WARF – his name was perfect. Bucky traveled across the state with me on rotation and across the country when I moved to Portland, OR for my residency. He spent a few years living above Boscobel Pharmacy and crossed into enemy territory spending two years in Minnesota. Bucky currently enjoys a comfortable life in Fitchburg, WI alongside his adopted brother Charlie (also a cat). He enjoys chilling in his cat tree, watching birds, lounging by the fireplace, and chasing strings.

Susan Kleppin, RPh, FASHP Director of Pharmacy Chartwell Midwest Wisconsin, Middleton

Unconditional love, true excitement to see me when I return home, my companion – no, I am not talking about a child or spouse, I am talking about my dog! Our dog, Latte, is not the first pet that I have had but she is the one that has had the biggest impact. Energetic, playful and smart, she has completely changed our daily lives. The health benefits of dog ownership are well documented and include getting more exercise and improvements in mood due to increased levels of serotonin and dopamine. In fact, a recently published review and meta-analysis described that dog ownership has been associated with lower risk of death over the long term, which is possibly driven by a reduction in cardiovascular mortality. Health benefits aside, our dog has won our hearts and we can’t imagine life without her. Besides, who could resist this face?

Kristen Gurney, PharmD Clinical Pharmacist REM Group, Madison

As a lifelong pet owner, I’ve always found great comfort in the company of animals. I was lucky enough to grow up on a small ranch, so as a kid I was surrounded by all sorts of 4-legged friends, whether that be horses, cats, or dogs. I’m currently the proud owner of two crazy cats, Ellie and Noodle. I got them 6 years ago when they were both kittens, and within a week of meeting they were the best of friends (and partners in crime when it came to making messes!). These days they’re much calmer and love nothing better than taking naps (often curled up together on my legs), but they still enjoy chasing each other around the house and playing with their huge array of toys. It’s a great feeling coming home after a long day and being greeted at the door by my little furballs…even if it is just because they’re hungry!

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Continuing Education PHARMACIST CE:

Pediatric QTc Prolongation: A Review of Risk Factors and Management Strategies by Meghan K Belden, PharmD, BCPPS, Vincent N DiChiara, PharmD, Kaitlin E Ryan, PharmD

T

he QT interval is a rate dependent interval calculated on an electrocardiogram (EKG) that reflects the time between ventricular depolarization and repolarization. In healthy adults, a normal QTc is typically less than 450 milliseconds (ms) for men and 460 ms for women while QTc greater than 500 ms has been associated with greater risk of ventricular arrhythmias.1 The QT interval varies with age in pediatric patients, but QTc prolongation is generally defined as greater than 460 ms or an increase from baseline of 60 ms.2-4 When the QT interval is prolonged, some myocardial cells become refractory which can result in spontaneous depolarization, known as early afterdepolarization. Early afterdepolarization can increase the risk of both ventricular dysrhythmias, such as torsade de pointes (TdP) or ventricular fibrillation, and sudden cardiac death.1,5 There are many factors that can contribute to prolongation of the QT interval including genetic causes such as congenital long QT syndrome (LQTS), advanced age, history of heart disease, hypothyroidism, bradycardia, electrolyte derangements, and medications.1,6-8 Many medications that cause prolongation of the QT interval interact with the delayed potassium rectifier channels in the cardiac myocyte. When the potassium ion channel is blocked, the action potential is prolonged, resulting in an increased QT interval.7 Antagonism of

8  The Journal

November/December 2019

CE FOR PHARMACISTS

COMPLETE ARTICLE AND CE EXAM AVAILABLE ONLINE: WWW.PSWI.ORG

Learning Objectives • Describe the pharmacist’s role in preventing pediatric QTc prolongation. • Explain the changes in QTc interval over time that impact a LQTS patient’s risk of experiencing a cardiac event. • Recommend appropriate electrocardiogram monitoring for patients with ADHD. • Identify the modifiable and non-modifiable risk factors for QTc prolongation. • Select an appropriate dose of magnesium for a pediatric patient experiencing torsade de pointes.

the potassium ion channel and resulting QTc prolongation is more likely to occur when multiple QTc-prolonging medications are utilized concurrently. TThe Credible Meds QT Drug List is a database identifying over 200 medications that carry risk of QTc prolongation and divides the medications into risk categories of known risk of TdP, conditional risk of TdP, and possible risk of TdP and also denotes drugs to avoid in LQTS.6 Although this list risk stratifies QTcprolonging medications, it is still essential that pharmacists critically evaluate the likelihood of QTc prolongation within the context of other patient risk factors in order to recommend medication therapy modifications if necessary. Table 1 reflects QTc-prolonging medications that are commonly utilized in pediatric patients. Pharmacists have an integral role in

recognizing patients with non-modifiable risk factors for QTc prolongation, intervening on modifiable risks such as electrolyte abnormalities including hypokalemia, hypomagnesemia, and hypocalcemia, as well as recommending appropriate medication therapies in order to prevent QTc prolongation and reduce the risk of ventricular arrhythmias and sudden cardiac death in pediatric patients.

Congenital Long QT Syndrome Congenital long QT syndrome is caused by mutations within genes involved in the function of myocyte sodium and potassium ion channels resulting in the delay of ventricular repolarization. Those with inheritable repolarization disorders are predisposed to malignant arrhythmias www.pswi.org


that can precipitate syncope, sudden cardiac arrest, or sudden cardiac death.9-13 Approximately 1 in 2,500 caucasians are afflicted with congenital LQTS, however this number is thought to be closer to 1 in 2,000 live births when considering patients with unconfirmed genotypes and normal QTc intervals.11 Diagnosis is based on the measurement of the QTc and subsequent rule out of secondary causes such as medication therapies and electrolyte abnormalities. Parameters to diagnose QTc prolongation vary by age and sex. In patients between 1 and 15 years of age, QTc interval greater than 460 ms is considered prolonged.10 The efficacy of EKG screening of infants and children for congenital LQTS is controversial. Some argue that it is cost-effective in preventing sudden infant death syndrome as well as sudden cardiac death in childhood, while others deem it unreliable and only necessary in patients with a family history of LQTS or in those presenting with clinical symptoms of cardiac dysfunction.14 LQTS is known to be an autosomal dominant disorder. While over 600 mutations have been found to affect 16 known LQTS genes, 3 of these genes make up 95% of genotype-positive LQTS and 75% of all diagnosed LQTS.10,12 LQT1 and LQT2 are related to gene mutations KCNQ1 and KCNH2, respectively, affecting potassium channel function. LQT3 is the result of the sodium channel gene mutation, SCN5A. Interestingly, literature has shown that each genotypic mutation has unique triggers that precipitate an event.10,15-17 Sympathetic activation induced by exercise puts patients with LQT1 at increased risk of developing an arrhythmia, while patients with the LQT2 genotype experience cardiac events during emotional stress and waking from sudden noises during sleep. Patients with the LQT3 genotype can experience events during sleep or at rest without either emotional stress or stimulating arousal. A variety of risk factors can contribute to a patient with LQTS experiencing a cardiac event. Risk increases in patients with a history of prior syncope or a QTc greater than 500 ms. Age and sex are also significant risk factors that impact pediatric patients. In a study conducted by Goldenberg et al, age related changes www.pswi.org

TABLE 1. QTc-Prolonging Medications Common to Pediatric Pharmacy9 QTc-Prolonging Medications Common to Pediatric Pharmacy Atomoxetine

Fluconazole

Amiodarone

Fluoxetine

Azithromycin

Haloperidol

Ciprofloxacin

Levofloxacin

Citalopram

Methadone

Diphenhydramine

Ondansetron

Erythromycin

Quetiapine

Escitalopram

Risperidone

Adapted from information obtained from CredibleMeds

differed in patients with LQT1. Females had lower risk of cardiac events than males when less than 16 years of age (HR 0.58; p=0.005), but a higher risk between 16 and 40 years old (HR 3.35; p=0.007).14,18 No difference in cardiac events was found between male or female LQT2 or LQT3 carriers less than 16 years of age, but LQT2 females had a significantly higher risk of developing their first cardiac event between 16 and 40 years old compared to male counterparts (HR 3.71; p=0.010). Results from Vink et al further support age-related differences of QTc intervals in children and adolescents with LQT1 and LQT2.13 In males with LQT1, QTc interval was found to shorten until 20 years of age (p=0.02), while there were no changes seen in the female sample. Similar results were seen in males with LQT2, where QTc prolongation was evident until puberty (p=0.0001) at which time it began shortening. LQT2 female patients showed a similar trend based on age (p=0.003). However, there was no difference in risk of cardiac events between groups. A possible explanation for these age and sex-related differences is the changes in sex hormone levels during puberty leading to developmental changes in the QTc interval, though this theory has proven difficult to assess.19 Poor patient adherence is a welldocumented risk factor for precipitating a cardiac event in patients with LQTS. In a single-center, prospective, observational study conducted by Ninomiya et al, it was found that non-adherence with medication

treatment was a sole risk factor for frequent symptoms after diagnosis (p=0.02).20 Non-adherence was defined as patients not taking their medicine for more than two days immediately before an LQTSrelated cardiac event. Waddell-Smith et al most recently published a study in 2016 on long-term beta-blocker adherence in familial LQTS.21 Adherence was assessed by calculating each patients’ medication possession ratio (MPR). MPR is calculated by comparing the days’ supply available to the patient based on refill history to a predetermined study period, typically 30 or 90 days. For example, if a patient receives a 30 day supply of medication with three refills and they are seven days late in picking up their third refill, then they only possessed an 83 day supply of medication during the 90 day period, giving them an MPR of 0.92. Adequate adherence in this study was defined as an MPR greater than or equal to 0.8, ideal being 1.0. Of the 68 patients included in the study, 51% (n=35) had suboptimal adherence with MPR less than 0.8, seven of which never filled a prescription. Patient rationale for non-adherence included disorganization, fear of adverse effects, and perceived low risk of having an event irrespective of cardiologist concerns. With the imminent risk of experiencing a cardiac event if not managed appropriately, pharmacists can play a critical role by assisting with patient compliance.

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Disease-States Associated with QTc Prolongation Attention-deficit hyperactivity disorder (ADHD) is the most commonly diagnosed pediatric neurobehavioral disorder, occurring in 8% of children.22 With 3.5 million children prescribed stimulants annually in the United States, it is likely that many pharmacists provide care to patients with ADHD on a regular basis.23 In the recent past, concerns have been raised regarding the safety of ADHD medication therapies in children due to reports of sudden cardiac death. Stimulants were associated with 6-15% of all pediatric sudden cardiac deaths and it is estimated that a sudden cardiac death occurs for every 4.5 million methylphenidate prescriptions filled.24 This is of particular concern as congenital heart disease is a risk factor for sudden cardiac death and ADHD is more common in children with congenital heart disease, occurring in two thirds of patients with hypoplastic left heart syndrome and in 50% of children with total anomalous pulmonary venous return.4 This combined information prompted the United States Food and Drug Administration (FDA) to consider addition of a black box warning for possible cardiovascular risks associated with stimulant medications. However, at the recommendation of the FDA Pediatric Advisory Committee, this warning was not pursued. Similarly, the American Heart Association (AHA) released recommendations in 2008 addressing cardiovascular monitoring in children receiving medication treatment for ADHD.4 These recommendations include obtaining an EKG prior to prescribing stimulants, atomoxetine, clonidine or guanfacine in order to detect patients with LQTS and were based on evidence of successful implementation of population screening in Japan, Italy and a variety of athletic associations in the United States. Additionally, the AHA recommends a repeat EKG at 12 years of age given the changes in QTc that can occur with puberty as previously discussed. Since the release of the AHA recommendations, several studies have been published to evaluate the cardiovascular effects of many of the medication therapies for ADHD alone and 10  The Journal

November/December 2019

in combination. A prospective, controlled study by Karpuz and colleagues of 285 children evaluated EKGs in children without ADHD, children with ADHD not receiving medication therapy, those treated with methylphenidate, those treated with risperidone and those receiving combination therapy with methylphenidate and risperidone.25 Notably, this study excluded patients with any history or symptoms of cardiovascular disorders and evaluated patients after three months of medication therapy. QTc was found to be significantly longer in all treatment arms compared to untreated ADHD and healthy controls (p<0.001). However, there were no arrhythmias or ST changes associated with this finding. Similarly, Sayer and colleagues performed a randomized, parallel group trial comparing cardiovascular effects of guanfacine monotherapy, dexmethylphenidate extended-release monotherapy and combination therapy in ADHD patients between 7 and 14 years old.26 Again, patients with personal or family history of cardiovascular disorders were excluded. There were no significant changes in QTc in any group and the authors concluded that these ADHD medications do not have any adverse effects on cardiovascular health. In a systematic review by Stiefel and colleagues, there was weak and inconsistent evidence that methylphenidate, amphetamines and atomoxetine can cause EKG changes in pediatric patients with ADHD, but these changes were not considered clinically significant.24 This prompted the AHA and American Academy of Pediatrics (AAP) to release a joint statement walking back the AHA’s previous guidelines noting that it is reasonable, but not mandatory, to obtain an EKG in ADHD patients prior to initiating medication therapy.27 Another population at increased risk of ventricular arrhythmias associated with QTc prolongation are post-surgical pediatric congenital heart disease patients. Congenital heart defects associated with cardiomyopathy and ventricular surgery, particularly single ventricle physiology, are known to be arrhythmogenic and patients commonly require pacing and antiarrhythmic medication management postoperatively.28 Additionally, many therapies utilized in the post-operative period, such

as epinephrine and steroids, can be proarrhythmic and electrolyte abnormalities are common. In this high risk population, it is essential that pharmacists consider the cumulative likelihood of QTc prolongation and ventricular arrhythmias associated with the patients’ medication regimens, drugdrug interactions and current condition. Only a limited number of QTcprolonging medications have been specifically evaluated in critically ill pediatric patients. Two case reports describe adolescent males with sepsis developing prolonged QTc and arrhythmias with fluconazole and ciprofloxacin.29,30 Fluconazole was associated with documented TdP while ciprofloxacin induced bradycardia. The patients had no other documented risk factors for QTc prolongation although it is possible there was end organ dysfunction associated with their sepsis which was not reported. In a small, single-centered, retrospective study investigating the safety of quetiapine for treatment of delirium in the pediatric intensive care unit, 19% (n=3) of EKGs obtained revealed QTc prolongation.31 However, none of these abnormalities resulted in arrhythmias and QTc prolongation resolved spontaneously or with dose reduction of quetiapine. Although large studies have demonstrated that ondansetron alone is infrequently associated with QTc prolongation or arrhythmias,3,32-34 these studies were performed in the general pediatric population and, often, excluded patients with congenital heart disease. In a retrospective cohort study of pediatric intensive care patients, 40% (n=57) of patients experienced QTc prolongation following ondansetron administration.35 Electrolyte abnormalities, end organ dysfunction and concomitant use of other QTc-prolonging medications displayed a statistically significant association with the occurrence of QTc prolongation (p<0.05) and patients with three or more risk factors for QTc prolongation were significantly more likely to develop QTc greater than 500 ms (p<0.05). However, no patients in the study experienced arrhythmias or TdP. The evidence related to methadone use in critically ill pediatric patients is mixed. In a retrospective, cohort study of 64 pediatric patients admitted to the www.pswi.org


pediatric intensive care unit, 21 children (33%) developed QTc prolongation following methadone initiation.36 Of note, 61% (n=39) of the study population had congenital heart disease putting them at higher risk of arrhythmia, but none of the instances of QTc prolongation resulted in TdP or any other type of arrhythmia. A limitation of the study was that the median time to EKG following methadone initiation was only 5 days. This may be an explanation for the differing results found by Schwinghammer et al in a retrospective, cohort study performed at University of California Davis Children’s Hospital.37 QTc prolongation was identified in 50.6% (n=45) of the study population and occurred more frequently in patients with cardiac disease and end organ dysfunction although these results were not statistically significant. Of interest, methadone is often used for prevention and management of iatrogenic withdrawal from opioids at the research institution. In evaluating this type of regimen on QTc prolongation, the authors found that QTc prolongation was more likely to occur with higher maximum methadone dose (OR 2.56; 95% CI 1.15-5.7), but that, in 48.9% (n=22) of patients with QTc prolongation, the longest measured QTc occurred during methadone tapering. Additionally, patients

www.pswi.org

who received more days of methadone therapy were more likely to develop QTc prolongation (OR 1.03, 95% CI 1.01-1.05). This demonstrates that QTc prolongation associated with methadone is not necessarily dose-dependent, but related to cumulative methadone exposure likely due to known accumulation of the drug over time and that patients remain at risk of QTc prolongation even with decreasing doses of methadone. In each of these studies a significant proportion of patients were excluded from enrollment due to lack of QTc monitoring, this exhibits an opportunity for pharmacists to identify patients at risk of QTc prolongation and request obtaining EKGs appropriately.

Management of LQTS and Torsade de Pointes For patients with familial LQTS, lifelong pharmacological management has been proven to reduce cardiac event rates. Beta-blockers are the treatment option of choice per the

American College of Cardiology, American Heart Association and European Society of Cardiology co-authored guidelines.12,38 They are recommended as a class 1 indication for all patients with a clinical diagnosis of LQTS and a class IIa indication for asymptomatic patients.38 Beta-blockers are believed to diminish the adrenergic-mediated triggers that could otherwise precipitate an event. Studies have shown that beta-blockers reduce the rate of syncope in all patients with LQTS, however a significant reduction in cardiac event rates was evident in LQT1 and LQT2, but not LQT3 patients.39 Also, patients who were symptomatic prior to starting beta-blocker therapy were 5.8 times more likely experience a recurrent cardiac event compared to asymptomatic patients. Unfortunately, randomized, prospective trials have not been conducted and, therefore, the impact of beta-blocker

November/December 2019

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use on mortality is yet to be established and there is not data available to conclude which beta-blocker is preferred over the others. In the event of cardiac arrest or LQTS patients who are deemed highrisk, ICD therapy is a class 1a indication. For patients who are deemed high-risk and ICD therapy is contraindicated, a left cardiac sympathetic denervation is considered a class 2a indication.10,12,38 Non-pharmacologic methods should be considered adjunct to medication therapy in order to further reduce risk of inciting a cardiac event in patients with LQTS. Patients should avoid adrenergic-type stimuli such as alarm clocks, loud doorbells, and ringtones.10 Patient education is also critical to avoid use of QTc-prolonging medications (Table 1) and to check with a pharmacist or cardiologist before taking over-the-counter medications.40 Immediate family should also be educated on how to properly respond to fainting episodes in order for the patient to receive prompt medical attention. Torsade de pointes is a potentially fatal result of an untreated prolonged QT interval. It can cease spontaneously or further develop into ventricular fibrillation. Patients that are hemodynamically unstable, or that become unresponsive or pulseless, should be managed according to standard resuscitation algorithms. This generally involves electric cardioversion and intravenous (IV) magnesium. In stable patients, it is imperative to initiate therapy promptly as they can decompensate rapidly. Whether it is for a single episode of TdP or for prevention of recurrent TdP, IV magnesium is a proven first-line therapy for initial management.12,40-44 Pediatric dosing ranges from 25 to 50 mg/kg, with a max of 2 grams. Management of TdP also involves amending any contributing factors such as correcting electrolyte derangements or discontinuing medications known to prolong the QT interval.12 Overdrive pacing is an option for patients refractory to stabilization with magnesium whether it is done mechanically via reprogramming an already existing implantable cardioverterdefribrillator (ICD) or medically via the titration of an isoproterenol continuous

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infusion to achieve a heart rate of 100 beats per minute in order to increase sinus heart rate and decrease the QT interval.12,40,41

The Pharmacist’s Role

Pharmacists have the opportunity to ensure that the risks associated with QTc prolongation in pediatric patients are adequately assessed, properly monitored and mitigated when possible. This concept is strongly supported in the adult literature. In a study conducted in the cardiac intensive care and intermediate care units at Indiana University Health Methodist Hospital, Tisdale and colleagues saw a 35% reduction in the odds of QTc prolongation with implementation of a best practice alert for pharmacists in the electronic health record.46 The alert was designed to notify pharmacists when QTc-prolonging medications were prescribed for patients at moderate to high risk of QTc-prolongation based on a validated risk assessment tool previously developed by the authors.46,47 Pharmacists were then prompted to either recommend alternative medication therapy, suggest increased monitoring of EKG and electrolytes or override the alert with no further action. Unfortunately, despite the tool being highly selective, 82% (n=382) of the best practice alerts were overridden with only 13% (n=51) resulting in increased monitoring and 17.9% (n=84) resulting in discontinuation of the prescribed medication. Although this research documents a pharmacist’s positive impact on clinical outcomes, it highlights the significant risk of alert fatigue when implementing strategies to identify patients at risk of QTc prolongation. Development of a pharmacist-driven algorithm has been found to be an effective strategy to ensure adequate QTc monitoring and reduce the risk of QTc prolongation in adult patients. Implementation of such a strategy at Barnabas Health Behavioral Health Center, an acute care adult psychiatric hospital in New Jersey, not only increased EKGs obtained in patients at risk of QTc prolongation by 26%, but also reduced EKGs obtained unnecessarily by a similar amount.48 Additionally, the authors saw a significant increase in pharmacist involvement in management of QTc prolongation from approximately 6 to nearly 98 interventions monthly. Similarly,

Ng and colleagues found a 50% reduction in all QTc prolongation and a 10-fold reduction in incidence of QTc greater than 500 ms after implementation of a pharmacist-driven algorithm in the medical intensive care and intermediate care units at University of Southern California Medical Center.49 These outcomes were achieved without any evidence of increased hospital length of stay or health-care costs. The results observed at these institutions demonstrate the ability of pharmacists to ensure cost-effective use of healthcare resources which is invaluable in this time of rising healthcare costs. Predictably, the pediatric evidence available on this topic is lacking and lags behind that of our adult colleagues, but shows promise. In a study by Hutchins and colleagues in 2017, a QTc monitoring protocol was developed by a pediatric cardiologist and clinical pharmacist which suggested obtaining a baseline EKG for patients on 3 or more QTc prolonging medications and a follow up EKG for patients remaining on that regimen for 5 or more days.50 The authors found that a follow up EKG was obtained in all patients that met criteria after the protocol was implemented compared to approximately 50% (n=11) of eligible patients during the pre-intervention period. Additionally, documented pharmacist interventions increased from 1.5 to 8 recommendations weekly with use of the protocol. Both of these findings were statistically significant (p<0.05). In distributing surveys to a variety of pediatric institutions, the authors discovered that only 11% (n=6) of respondents had policies or procedures related to medication-induced QTc prolongation monitoring in place and only half of institutions utilized any kind of alert in the electronic medical record for pharmacists, prescribers or nurses to review. This displays another opportunity for pharmacists to influence patient care and ensure safe medication monitoring practices at their institution through development, implementation and promotion of a policy or protocol addressing QTc prolongation and the risk of TdP. It is not only hospitalized pediatric patients that could benefit from pharmacist involvement in QTc prolongation risk assessment. Many medication therapies www.pswi.org


utilized for pediatric disease states treated in the outpatient setting, such as ADHD and depression, carry a risk of QTc prolongation. The AHA and AAP recommend that children prescribed medication therapy for treatment of ADHD be carefully assessed for heart conditions, including a thorough interview gathering the patient’s past medical history and family history.27 A family history of cardiomyopathy, LQTS, WolffParkinson-White syndrome or Marfan syndrome warrant a referral to a pediatric cardiologist.4 It would be prudent for pharmacists to include this evaluation when counseling patients and their families on new stimulant and atypical antipsychotic prescriptions. Additionally, outpatient pharmacists have the opportunity to identify patients at higher risk of TdP that may benefit from EKG monitoring such as patients with history of LQTS and those being treated with multiple QTcprolonging medications.

Conclusion

Although occurring less frequently than in adults, pediatric patients remain at risk of QTc prolongation and appropriate monitoring is essential in identifying patients with LQTS in order to prevent severe cardiac events such as sudden cardiac death secondary to TdP. Pediatric patients receiving QTc-prolonging medications should be evaluated for other factors known to contribute to QTc prolongation such as cardiac conditions, electrolyte abnormalities, drug-drug interactions, end organ dysfunction affecting drug metabolism and additional medication therapies that may prolong QTc. Patients with LQTS require education on their significant risk of a cardiac events, the importance of medication compliance and how to manage their condition both pharmacologically and nonpharmacologically. Given the rarity of protocols related to QTc monitoring in pediatric institutions, pharmacists are also needed to establish these types of policies in order to promote institutional changes within the health system. These are all areas of opportunity for both inpatient and outpatient pharmacists to have a valuable impact on patient safety in preventing adverse outcomes. www.pswi.org

Meghan Belden, Vincent DiChiara, and Kaitlin Ryan are Clinical Pharmacists at Children’s Hospital of Wisconsin in Milwaukee, WI.

P

R

This article has been peer-reviewed. The contribution in reviewing is greatly appreciated!

Disclosure: The authors declare no real or potential conflicts or financial interest in any product or service mentioned in the manuscript, including grants, equipment, medications, employment, gifts and honoraria.

References

1. Pourmand A, Mazer-Amirshahi M, Chistov S, Sabha Y, Vukomanovic D, Almulhim M. Emergency department approach to QTc prolongation. Am J Emerg Med. 2017;35(12): 1928-1933. 2. Kamphuis VP, Blom NA, vanZwet EW, et al. Normal values of the ventricular gradient and QRS-T angle, derived from the pediatric electrocardiogram. J Electrocardiol. 2018;51(3):490-495. 3. Krammes SK, Jacobs T, Clark JM, Lutes RE. Effect of intravenous ondansetron on the QT interval of patients’ electrocardiograms. Pediatr Emerg Care. 2018;34(1):38-41. 4. Vetter VL, Elia J, Erickson C, et al. Cardiovascular monitoring of children and adolescents with heart disease receiving medications for attention deficit/hyperactivity disorder: a scientific statement from the American Heart Association Council on Cardiovascular Disease in the Young Congenital Cardiac Defects Committee and the Council on Cardiovascular Nursing. Circulation. 2008;117(18):2407-23. 5. Clancy C. Electrophysiologic and Electrocardiographic Principles. In: Hoffman RS, Howland M, Lewin NA, Nelson LS, Goldfrank LR. eds. Goldfrank's Toxicologic Emergencies, 10e. New York, NY: McGraw-Hill; 2015. 6. Othong R, Wattanasansomboon S, Kruutsaha T, et al. Utility of QT interval corrected by Rautaharju method to predict drug-induced torsades de pointes. Clin Toxicol. 2019;57(4)234-239. 7. Charlton NP, Lawrence DT, Bady WJ, Kirk MA, Holstege CP. Termination of druginduced torsades de pointes with overdrive pacing. Am J Emerg Med. 2010;28(1):95-102. 8. Thomas SH, Behr ER. Pharmacological treatment of acquired QT prolongation and torsades de pointes. Br J Clin Pharmacol. 2016;81(3):420-427. 9. Woosley, RL, Heise, CW and Romero, KA. Risk categories for drugs that prolong QT & induce torsades de pointes. www.crediblemeds. org. Published July 6, 2018. Updated June 25, 2019. Accessed July 25, 2019. 10. Barsheshet A, Dosenko O, Goldenberg I. Congenital long QT syndromes: prevalence, pathophysiology and management. Pediatr Drugs. 2014;16(6):447-456. 11. Schwartz PJ, Stramba-Badiale M, Crotti L, et al. Prevalence of the congenital long-QT syndrome. Circulation. 2009;120(18):1761-7. 12. Priori SG, Wilde AA, Horie M, Cho Y, et al.

HRS/EHRA/APHRS expert consensus statement on the diagnosis and management of patients with inherited primary arrhythmia syndromes: document endorsed by HRS, EHRA, and APHRS in May 2013 and by ACCF, AHA, PACES, and AEPC in June 2013. Heart Rhythm. 2013;10(12):1932–63. 13. Vink AS, Clur SB, Geskus RB, et al. Effect of age and sex on the QTc interval in children and adolescents with type 1 and 2 long-QT syndrome. Circ Arrhythm Electrophysiol. 2017;10(4):e004645. 14. Sumitomo N. Clinical features of long QT syndrome in children. Circ J. 2016;80(3):598-600. 15. Schwartz PJ, Priori SG, Spazzolini C, et al. Genotype-phenotype correlation in the long-QT syndrome: gene-specific triggers for life-threatening arrhythmias. Circulation. 2001;103(1):89-95. 16. Goldenberg I, Thottathil P, Lopes CM, et al. Trigger-specific ion-channel mechanisms, risk factors, and response to therapy in type 1 long QT syndrome. Heart Rhythm. 2012;9(1):49-56. 17. Kim JA, Lopes CM, Moss AJ, et al. Trigger-specific risk factors and response to therapy in long QT syndrome type 2. Heart Rhythm. 2010;7(12):1797-805. 18. Goldenberg I, Moss AJ. Long QT syndrome. J Am Coll Cardiol. 2008;51(24):2291-2300. 19. Vink AS, Clur SAB, Wilde AAM, Blom NA. Effect of age and gender on the QTc-interval in healthy individuals and patients with long-QT syndrome. Trends Cardiovasc Med. 2018;28(1):64-75. 20. Ninomiya Y, Yoshinaga M, Kucho Y, Tanaka Y. Risk factors for symptoms in long QT syndrome patients in a single pediatric center. Pediatr Int. 2013;55(3):277-82. 21. Waddell-Smith KE, Li J, Smith W, et al. Betablocker Adherence in Familial Long QT syndrome. Circ Arrhythm Electrophysiol. 2016;9(8):e003591. 22. Wolraich M, Brown L, Brown RT, et al. ADHD: clinical practice guideline for the diagnosis, evaluation, and treatment of attentiondeficit/hyperactivity disorder in children and adolescents. Pediatrics. 2011;128(5):1007-22. 23. Visser SN, Danielson ML, Bitsko RH, et al. Trends in the parent-report of health care providerdiagnosed and medication attention-deficit/ hyperactivity disorder: United States, 2003-2011. J Am Acad Chil Adolesc Psychiatry. 2014;53:34-46. 24. Stiefel G, Besag FM. Cardiovascular effects of methylphenidate, amphetamines and atomoxetine in the treatment of attention-deficit hyperactivity disorder. Drug Saf. 2010;33(10):821-842. 25. Karpuz D, Hallioglu O, Toros F, Tasdelen B. The effect of metilpheniydate, risperidone and combination therapy on ECG in children with attention-deficit hyperactivity disorder. J Electrocardiol. 2017;50(4):410-415. 26. Sayer GR, McGough JJ, Levitt J, et al. Acute and long-term cardiovascular effects of stimulant, guanfacine, and combination therapy for attention-deficit/hyperactivity disorder. J Child Adolesc Psychopharmacol. 2016;26(10):882-888. 27. Wolraich ML. Recommendations for cardiovascular evaluation and monitoring of children and adolescents receiving medications for ADHD. In: Caring for Children with ADHD: a Resource Toolkit for Clinicians. 2 ed. Itasca, IL: American Academy of Pediatrics; 2011. https://www.aap.org/en- us/pubserv/ November/December 2019

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adhd2/Pages/kit/data/papers/Recommendations %20 for%20Card.F0907.pdf Accessed May 26, 2019. 28. DiMaria MV, Boris JR, Vetter VL. Chapter 1. Normal cardiac physiology and the cardiac exam. In: Gleason M, Rychik J, Shaddy R. eds. Pediatric Practice: Cardiology. New York, NY: McGraw-Hill; 2012. 29. Esch JJ, Kantoch MJ. Torsades de pointes ventricular tachycardia in a pediatric patient treated with fluconazole. Pediatr Cardiol. 2008;29(1):210-213. 30. Knoff JP, Moshfeghi M, Sokoloski MC. Ciprofloxacin-induced Q-T interval prolongation. Am J Health Syst Pharm. 2008;65(6):547-551. 31. Joyce C, Witcher R, Herrup E, et al. Evaluation of the safety of quetiapine in treating delirium in critically ill children: a retrospective review. J Child Adolesc Psychopharmacol. 2015;25(9):666-670. 32. Hoffman RJ, Alansari K. Effect of intravenous ondansetron on QTc interval in children with gastroenteritis. Am J Emerg Med. 2018;36(5):754-757. 33. Moeller JR, Gummin DD, Nelson TJ, et al. Risk of ventricular arrhythmias and association with ondansetron. J Pediatr. 2016;179:118-123. 34. Trivedi S, Schiltz B, Kanipakam R, et al. Effect of ondansetron on QT interval in patients cared for in the PICU. Pediatr Crit Care Med. 2016;17(7):317-323. 35. Heath TS, Greenberg RG, Hupp SR, et al. Effects of methadone on corrected Q-T interval prolongation in critically ill children. J Pediatr Pharmacol Ther. 2018;23(2):119-124. 36. Schwinghammer AJ, Wilson MD, Hall BA. Corrected QT interval prolongation in hospitalized pediatric patients receiving methadone. Pediatr Crit Care Med. 2018;19(8):403-408. 37. Zipes DP, Camm AJ, Borggrefe M, et al. ACC/AHA/ESC 2006 guidelines for management of patients with ventricular arrhythmias and the prevention of sudden cardiac death: a report of the American College of Cardiology/American Heart Association Task Force and the European Society of Cardiology Committee for Practice Guidelines (writing committee to develop guidelines for management of patients with ventricular arrhythmias and the prevention of sudden cardiac death). J Am Coll Cardiol. 2006;48(5):e247-346. 38. Moss AJ, Zareba W, Hall WJ, et al. Effectiveness and limitations of beta-blocker therapy in congenital long-QT syndrome. Circulation. 2000;101(6):616-623. 39. Moss AJ. Long QT Syndrome. JAMA. 2003;289(16):2041-44. 40. Tzivoni D, Banai S, Schuger C, et al. Treatment of torsade de pointes with magenesium sulfate. Circulation. 1988;77(2):392-397. 41. Hoshino K, Ogawa K, Hishitani T, Isobe T, Etoh Y. Successful uses of magnesium sulfate for torsades de pointes in children with long QT syndrome. Pediatr Int. 2006;48(2):112-117. 42. Passman R, Kadish A. Polymorphic ventricular tachycardia, long Q-T syndrome, and torsades de pointes. Med Clin North Am. 2001;85(2):321-341. 43. Khan IA. Long QT syndrome: diagnosis and management. Am Heart J. 2002;143(1):7-14. 44. Waddell-Smith KE, Earle N, Skinner JR. Must every child with long QT syndrome take a beta

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blocker?. Arch Dis Child. 2015;100(3):279-282. 45. Tisdale JE. Drug-induced QT interval prolongation and torsades de pointes: role of the pharmacist in risk assessment, prevention, and management. Can Pharm J. 2016;149(3):139-152. 46. Tisdale JE, Jaynes HA, Kingery JR, et al. Effectiveness of a clinical decision support system for reducing the risk of QT interval prolongation in hospitalized patients. Circ Cardiovasc Qual Outcomes. 2014;7(3):381-90. 47. Tisdale JE, Jaynes HA, Kingery JR, et al. Development and validation of a risk score to predict QT interval prolongation in hospitalized patients. Circ Cardiovasc Qual Outcomes. 2013;6(4):479-487. 48. Daniel NM, Walsh K, Leach H, Stummer L. Implementation of a QTc-interval monitoring protocol by pharmacists to decrease cardiac risk in at-risk patients in an acute care inpatient psychiatric facility. Ment Health Clin. 2019;9(2):82-87. 49. Ng TM, Bell AM, Hong C, et al. Pharmacist monitoring of QTc interval-prolonging medications in critically ill medical patients: a pilot study. Ann Pharmacother. 2008;42(4):475-82. 50. Hutchins LM, Temple JD, Hilmas E. Impact of pharmacist intervention on electrocardiogram monitoring of pediatric patients on multiple QTc interval-prolonging medications. J Pediatr Pharmacol Ther. 2017;22(6):399-405.

Assessment Questions 1.

2.

3.

True or False: The United States Food and Drug Administration currently requires a “black box” warning for sudden cardiac death on all stimulant medications. a. True b. False The American Heart Association suggests that it is reasonable to obtain an electrocardiogram prior to initiation of which ADHD medication therapy or therapies? a. Methylphenidate b. Guanfacine c. Clonidine d. Atomoxetine e. All of the above According to the American Heart Association, a family history of which of the following disease states does NOT require evaluation by a pediatric cardiologist prior to initiating medication therapy for ADHD? a. LQTS b. Cardiomyopathy c. Congenital Heart Disease d. Wolff-Parkinson-White Syndrome

4.

5.

6.

7.

8.

9.

True or False: Pre-pubescent LQT1 females are at higher risk of experiencing a cardiac event than pre-pubescent LQT1 males. a. True b. False A 17 year old female patient with LQTS weighing 60 kilograms arrives at the EDTC after experiencing an episode of syncope. Her EKG is showing signs of torsade de pointes. The physician would like to give a dose of magnesium to stabilize the patient. What dose do you recommend? a. 50 mg/kg of magnesium sulfate, max dose of 3000 mg b. 20 mg/kg of magnesium sulfate, max dose of 1500 mg c. 50 mg/kg of magnesium sulfate, max dose of 2000 mg d. 15 mg/kg of magnesium sulfate, max dose of 1000 mg

True or False: The CredibleMeds QT Drug List indicates which QTc-prolonging medications cannot be administered concurrently. a. True b. False True or False: If a patient develops torsade de pointes, the recommended first line treatment is an isoproterenol continuous infusion. a. True b. False True or False: The mechanism by which many medications prolong the QT interval is by blocking the delayed potassium rectifier channels in the cardiac myocyte. a. True b. False Which of the following are risk factors for QTc prolongation? a. Congenital heart defects b. LQTS c. Tachycardia d. A & B

10. Did the activity meet the stated learning objectives? (if you answer no, please email sarahs@pswi.org to explain) a. Yes b. No 11. On a scale of 1 – 10 (1-no impact; 10-strong impact), please rate how this program will impact the medication therapy management outcomes or safety of your patients.

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12. On a scale of 1 – 10 (1-did not enhance; 10-greatly enhanced), please rate how this program enhanced your competence in the clinical areas covered.

16. Learning assessment questions were appropriate. a. Yes b. No

13. On a scale of 1 – 10 (1-did not help; 10-great help), please rate how this program helped to build your management and leadership skills.

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14.

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15. How effective were the learning methods used for this activity? a. Very effective b. Somewhat effective c. Not effective

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Continuing Education Credit Information The Pharmacy Society of Wisconsin is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Continuing education credit can be earned by completing the self assessment questions. Questions may be completed online at www. pswi.org or by mailing completed answer form to PSW, 701 Heartland Trail, Madison, WI 53717. Participants receiving a score of 70% or better will be granted 1 hour (0.1 CEU) credit through CPE Monitor within 60 day of quiz completion. Accurate birth date (MMDD) and CPE Monitor ID must be provided in order to receive this credit as required by ACPE. This CE offering is offered free-of-charge t o a l l P S W m e m b e r s . No n m e m b e r s a r e charged $20 for each exam submitted to cover administrative costs.

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November/December 2019 Pediatric QTc Prolongation: A Review of Risk Factors and Management Strategies

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The Journal 15


Features

ID CORNER Urine Trouble: Optimizing the Management of Pediatric UTIs in the Outpatient Setting by Katie M Ray, PharmD, Tracy N Zembles, PharmD, BCPS-AQ ID, Michelle L Mitchell, MD

U

rinary tract infections (UTI) are relatively common in children and present with a broad range of clinical symptoms of varying severity that may include bacteremia and/or septic shock. UTIs account for 5-14% of all pediatric emergency department (ED) visits and 0.7% of ambulatory care visits.1 Studies suggest up to 8% of girls and 1.7% of boys will have a UTI diagnosed by 7 years of age.2 While infants and children may have asymptomatic bacteriuria, neither screening/testing nor treatment in these cases is warranted.3 The purpose of this article is to describe patients presenting with symptoms that may be attributable to a UTI. The prevalence of UTI varies by gender, race, age and circumcision status.4 While an estimated 7% of all infants presenting with fever have a UTI (including 8.3% of girls), the estimate increases to about 20% in febrile uncircumcised males under three months of age.4 Studies evaluating older patients (up to 19 years old) with urinary symptoms with or without fever found a similar rate of UTI to that of febrile infants (7.8%).4 The most common pathogens in all age groups are Escherichia coli, Klebsiella pneumoniae and Proteus mirabilis.5,6 Other common pathogens include Enterococcus faecalis and Staphylococcus species.6 UTIs in young children may increase the probability of developing renal scarring and/or hypertension; therefore, making a diagnosis accurately and efficiently is important.7 However, diagnosing UTIs in young children (i.e. preverbal children or children unable to adequately identify and communicate symptoms to their caregiver) pose unique challenges not encountered in adults or older children;

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November/December 2019

the presentation can be vague and nonspecific. Infants often present exclusively with fever, whereas older children typically present with increased frequency, dysuria, and/or new incontinence. The diagnosis of a UTI is typically based on a urinalysis (UA) and urine culture in children. The decision to obtain a UA should be based on patient characteristics, symptoms and epidemiologic risk factors. There are published probability estimates based on the number of risk factors present.8,9 However, the American Academy of Pediatrics (AAP) does not have a recommended threshold where testing and treatment are endorsed but rather leaves it to the individual provider to make a value judgement.9 Thus, among pediatric clinicians, there can be wide variability in the threshold for testing due to the many variables that affect patient risk as well as diagnostic standards that may involve invasive and unpleasant tests (catheterization and suprapubic taps for incontinent children). To help

address variability, several institutions have developed clinical pathways to standardize and guide the evaluation and management of children with a possible UTI. One group of investigators developed a calculator based on age, gender, race, circumcision status, and fever presence/ source to streamline the risk assessment in children under 24 months of age (available to the public at https://uticalc. pitt.edu/).10 When this calculator was applied to a population of 1000 children less than 2 years presenting with fever and compared to the AAP algorithm, the need for urine sampling was reduced by 8.1% and the estimated number of missed cases was reduced from three to 0 per 1,000 febrile children.10 Another large center developed a two-step process for evaluating UTIs in children to decrease unnecessary catheterizations.11 In this approach, a bag specimen was first collected to evaluate for pyuria and/or nitrites. If consistent with a UTI (moderate or large leukocyte esterase or nitrite positive), a reflex catheterized

TABLE 1. Empiric Oral Antimicrobial Agents for Treatment of Urinary Tract Infections Oral Antimicrobial Agent

Dosage

Amoxicillin-clavulanate

20 – 40 mg/kg/day in 3 doses

Trimethoprim-sulfamethoxazole

6 – 12 mg/kg/day trimethoprim in 2 doses

Cefixime

8 mg/kg/day in 1 dose

Cefpodoxime

10 mg/kg/day in 2 doses

Cefprozil

30 mg/kg/day in 2 doses

Cefuroxime

20 – 30 mg/kg/day in 2 doses

Cephalexin

50 – 100 mg/kg/day in 3-4 doses

Cefdinir*

14 mg/kg/day in 1-2 doses

Adapted from Roberts 2011 *All antimicrobials listed in this table are included in the AAP guidelines except for cefdinir 9

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urine culture was obtained for culture prior to antibiotic administration, given reported rates of contamination with bag collection are > 60%.12 This process reduced catheterization rates from 63% to less than 30% in febrile children 6-24 months old without any identified adverse outcomes.11 Although bag specimens also have the potential to prolong a visit, this was minimally seen by Lavell et al, with an increased length of stay of 12 minutes.11 When the decision is made to treat a patient for suspected UTI, clinicians must balance the risks and benefits of antibiotics and duration of therapy. Antimicrobial use, whether appropriate or inappropriate, is associated with a risk of adverse drug events and development of antibiotic resistant organisms. Therefore, it is important to establish appropriate criteria for diagnosis and empiric treatment using the most narrow spectrum antibiotic reasonable and for the optimal duration. The goals of treatment for UTIs include eradication of the culprit pathogen and easing symptoms while minimizing adverse effects. Initial antibiotics are directed at

TABLE 2. Percent of Susceptible Isolates for Common Urinary Pathogens Among Pediatric Outpatients in our Health System Escherichia coli (n = 625)

Klebsiella Pneumoniae (n = 45)

Proteus mirabilis (n = 51)

Percent Susceptible Ampicillin/sulbactam

57

85

94

Cefazolin (uncomplicated UTI)

91

95

94

Cefazolin (systemic infection)

77

84

0

Ceftriaxone

93

98

98

Sulfamethoxazole/trimethoprim

77

93

92

the most likely pathogens and may need to be adjusted following results of urine culture and susceptibility testing. Oral antibiotics are typically effective for the treatment of UTIs in the outpatient setting. Although amoxicillin has historically been a first-line antibiotic for UTIs, increased rates of resistance have limited its use. Other oral options recommended by the AAP and the European Association of Urology include amoxicillin/clavulanic acid, oral cephalosporin antibiotics (e.g.,

cephalexin, cefixime, cefpodoxime), or sulfamethoxazole/trimethoprim (Table 1)9,13 These guidelines provide significant room for variability with drug selection, noting that empiric therapy should be based on local susceptibility patterns of Escherichia coli and other common urinary pathogens. Many regions in the United States show increasing rates of Escherichia coli resistance to amoxicillin/clavulanic acid and sulfamethoxazole/trimethoprim, precluding their use as first line agents. This

FIGURE 1. Clinical Practice Guideline for the Treatment of Urinary Tract Infection in the Outpatient Setting

Figure 1 legend. Clinical practice guideline for treatment of urinary tract infections in the outpatient setting. Pathways based on signs, symptoms, and age are included. The procedure for nurse (RN) follow up is outlined.

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The Journal 17


is consistent with our local antibiogram which shows resistance rates exceeding 20% for sulfamethoxazole/trimethoprim and 40% for amoxicillin/clavulanic acid. Receipt of antimicrobial therapy in the recent past and susceptibility patterns of any prior urinary pathogens should also be considered in the initial choice of treatment. The Clinical and Laboratory Standards Institute (CLSI) created urine specific breakpoints for enterobacteriaceae in 2014, which should be considered when interpreting a local antibiogram.14 These breakpoints predict susceptibility for cefazolin for the most common urine pathogens (Escherichia coli, Klebsiella Pneumoniae, and Proteus mirabilis) at a higher minimum inhibitory concentration (MIC) than non-urine specimens. Furthermore, cefazolin may be used as a surrogate to predict susceptibility to other cephalosporin antibiotics (i.e., cefaclor, cefdinir, cefpodoxime, cefprozil, cefuroxime, cephalexin, and loracarbef ) (Table 2). The optimal duration of therapy for treatment of pediatric UTIs has not been clearly defined. Short courses (1-3 days) for uncomplicated cystitis are recommended in adults and are as effective as longer

TABLE 3. Comparison of Pharmacokinetic Profiles of Cefdinir and Cephalexin Cefdinir*

Cephalexin^

Oral bioavailability (%)

25

90

Peak serum concentration (µg/mL)

1.6

18

21 – 139

5,000 – 10,000

60 – 70

5 – 15

1.7

1–2

Range of Urine Concentration (µg/mL) Protein binding (%) Half-life (hours)

Adapted from Gilbert 2015 and Gilbert 2006 * Based on a single 300 mg dose ^ All data based on a single 500 mg dose, except urine drug concentration, which is based on a single 1,000 mg dose 20

21

therapy.15 However, this practice has not been widely adopted in pediatrics, in part due to difficulty distinguishing cystitis from pyelonephritis in young children. The AAP recommended duration is intentionally vague, citing a lack of data, and concludes a duration of 7-14 days is appropriate for most febrile infants.9 Meanwhile, the European Association of Urology recommends children over 3 months receive a minimum of 3-4 days duration for cystitis and 7-14 days for a febrile UTI.13 These recommendations are guided by two major pediatric meta-analyses, as individual randomized controlled trials

FIGURE 2. Summary of Antibiotic Prescribing for Urinary Tract Infections in the Pediatric Emergency Department

Figure 2 legend. Percent of all first or third generation cephalosporin antibiotics prescribed for a UTI in the emergency department. A revised urinary tract infection guideline was implemented during the first quarter of 2019. Solid lines represent first generation cephalosporin antibiotic prescriptions. Dotted lines represent third generation cephalosporin antibiotic prescriptions.

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were often limited by small sample sizes.16,17 Michael et al. compared the effectiveness of short course (2-4 days) with standard duration (7-14 days) among children aged 3 months to 18 years with culture proven symptomatic UTI.17 They found no significant difference in the frequency of recurrent UTI or development of resistant organisms between a short and standard course.17 Keren et al. compared the effectiveness of short course (≤ 3 days) with standard duration (7-14 days) among children aged 0 days to 18 years treated for an acute UTI in the outpatient setting.16 In the pooled analyses, standard course was associated with fewer treatment failures. However, Keren et al. acknowledged “single dose” trials included in their study may explain the difference in conclusions.18 We assessed our local antibiogram using CLSI urine specific breakpoints, and determined cephalexin was the narrowest spectrum antibiotic that could empirically cover the majority of likely pathogens. Although cefdinir has been prescribed to treat outpatient UTIs in our system, it is unnecessarily broad for the treatment of common urinary pathogens (Table 2). Additionally, the pharmacokinetic profile of cefdinir is inferior to cephalexin. Cephalexin has significantly higher bioavailability and less protein binding than cefdinir. However, cephalexin does require a more frequent dosing schedule due to its short half-life (Table 3). Both cefdinir and cephalexin are generally well tolerated. However, cefdinir can cause red stools in children when administered with products that contain iron such as oral iron supplements or some infant www.pswi.org


formulas. The true incidence of red stools resulting from cefdinir is unknown, but reports range from 1-10%.19 The red color can be extreme and may appear similar to blood, resulting in unnecessary visits to primary care providers and EDs. Although trimethoprim-sulfamethoxazole is another commonly used agent for outpatient UTI treatment, our antibiogram reveals suboptimal coverage for Escherichia coli compared to cephalosporins. Our pediatric ED, in partnership with the antimicrobial stewardship program, favored the change to cephalexin for empiric treatment of suspected UTIs in pediatric patients discharged from the ED. This resulted in a collaborative practice guideline (Figure 1). Diagnostics are based on a UTI calculator available online for patients of applicable age.10 The guideline recommends a treatment duration of 10 days for all pediatric patients treated outpatient for pyelonephritis (Figure 1). Treatment durations are age-based for cystitis with 7 days recommended for children > 2 years and < 12 years old and 3 days for patients 12 years or older. Preliminary data show initial adherence to the guideline (Figure 2). UTIs account for a large number of pediatric emergency department and ambulatory care visits each year, yet national guidelines remain vague regarding diagnostics and treatment. Unlike treatment of UTIs in adult patients, narrow spectrum agents (i.e., cephalexin) are expected to be sufficient for pediatric UTI treatment in many regions. Use of this narrow spectrum antibiotic is supported by our local antibiogram. Future studies are planned to evaluate guideline compliance and outcomes associated with the use of cephalexin as initial empiric therapy. Katie Ray and Tracy Zembles are Pharmacists in the Department of Enterprise Safety at Children’s Hospital and Health System in Milwaukee, WI. Michelle Mitchell is a Medical Doctor in the Department of Pediatrics and Infectious Diseases at the Medical College of Wisconsin and Children’s Hospital and Health System in Milwaukee, WI.

P

R

This article has been peer-reviewed. The contribution in reviewing is greatly appreciated!

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Disclosures: The authors declare no real or potential conflicts or financial interest in any product or service mentioned in the manuscript, including grants, equipment, medications, employment, gifts and honoraria.

References

1. Freedman AL. Urologic Diseases in North America Project: trends in resource utilization for urinary tract infections in children. J Urol. 2005;173(3):949-954. 2. Hellström A, Hanson E, Hansson S, Hjälmås K, Jodal U. Association between urinary symptoms at 7 years old and previous urinary tract infection. Arch Dis Child. 1991;66(2):232-234. 3. Nicolle LE, Gupta K, Bradley SF, et al. Clinical practice guideline for the management of asymptomatic bacteriuria: 2019 update by the Infectious Diseases Society of America. CID. 2019;68(10):83-75. 4. Shaikh N, Morone NE, Bost JE, Farrell MH. Prevalence of UTI in childhood: a meta-analysis. Pediatr Infect Dis J. 2008;27(4):302-308. 5. Spahiu L, Hashbata V. Most frequent cause of urinary tract infection in children. Med Arh. 2010;64(2):88-90. 6. Flores-Mireles AL, Walker JN, Caparon M, Hultgren SJ. Urinary tract infections: epidemiology, mechanisms of infection and treatment options. Nat Rev Microbiol. 2015;13(5):269-284. 7. Montini G, Tullus K, Hewitt I. Febrile urinary tract infections in children. N Engl J Med. 2011;365(3):239-250. 8. Shaikh N, Morone NE, Lopez J, et al. Does This child have a urinary tract infection? JAMA. 2007;298(24):2895-2904. 9. Roberts KB, Downs KM, Finnell SME, et al. Subcommittee on Urinary Tract Infection, Steering Committee on Quality Improvement and Management. Urinary tract infection: clinical practice guideline for the diagnosis and management of the initial UTI in febrile infants and children 2 to 24 months. Pediatrics. 2011;128(3):595-610. 10. Shaikh N, Hoberman A, Hum SW, et al. Development and validation of a calculator

Find the Perfect Job or a Great Employee

for estimating the probability of urinary tract infection in young febrile children. JAMA Pediatr. 2018;172(6):550-556. 11. Lavell JM, Blackstone MM, Funari MK, et al. Two-step process for ED UTI screening in febrile young children: reducing catheterization rates. Pediatrics. 2016;138(1):e20153023. 12. Al-Orifi F, McGillivray D, Tange S, Kramer MS. Urine culture from bag specimens in young children: are the risks too high? J Pediatr. 2000;137(2):221-226. 13. Stein R, Dogan HS, Hoebeke P, et al. Urinary tract infections in children: EAU/ESPU Guidelines. European Urology. 2015;67(3):546-558. 14. Clinical and Laboratory Standards Institute (CLSI). Performance standards for antimicrobial susceptibility testing-fourth informational supplement (Update). CLSI document. Wayne: CLSI; 2014. 15. Gupta K, Hooton TM, Naber KG, et al. International clinical practice guidelines for the treatment of acute uncomplicated cystitis and pyelonephritis in women: a 2010 update by the Infectious Diseases Society of America and the European Society for Microbiology and Infectious Diseases. Clin Infect Dis. 2011;52(5):e103-e120. 16. Keren R, Chan E. A meta-analysis of randomized controlled trials comparing short- and long-course antibiotic therapy for urinary tract infections in children. Pediatrics. 2002;109(5):e70. 17. Michael M, Hodson EM, Craig JC, Martin S, Moyer VA. Short compared with standard duration of antibiotic treatment for urinary tract infection: a systematic review of randomized controlled trials. Arch Dis Child. 2002;87(2):118-123. 18. Keren R, Chen E. Short versus standard duration antibiotic treatment for UTIs: a comparison of two meta-analyses. Arch Dis Child. 2003;88(1):87-93. 19. Graves R, Weaver SP. Cefdinirassociated “bloody stools” in an infant. J Am Board Fam Med. 2008;21(3):246-248. 20. Gilbert DN, Eliopoulos GM, Chambers HF, et al. The Sanford guide to antimicrobial therapy 2015. Sperryville, VA: Antimicrobial Therapy, Inc. 21. Gilbert DN. Urinary tract infections in patients with chronic renal insufficiency. Clin J Am Soc Nephrol. 2006;1(2):327-331.

careers.pswi.org November/December 2019 The Journal

19


Features WPQC UPDATE:

Unique CMR Implementation Strategies: Streu’s Pharmacy Expansion of Clinical Services by Nicole Schreiner, PharmD, Taylor Millar, 2022 PharmD Candidate, Gabrielle Gaura, CPhT

O

ur pharmacy had been completing Comprehensive Medication Reviews (CMRs) periodically in our community setting, but like many pharmacies we were struggling with barriers to fully implement this service. In order to surmount the barriers, we implemented two new strategies. First, approximately six months ago, we created a new role in our organization called the Clinical Technician. Our goal in creating a technician role related to CMRs was to expand the utility of a technician and have the pharmacist perform only the part of the CMR that required clinical expertise. Second, Streu’s Pharmacy combines a traditional community pharmacy and a closed door long term care (LTC) pharmacy in one building. We serve over 1800 patients in our LTC pharmacy. Realizing that we were not even tapping into this patient population for CMR services, we created a new CMR service specifically for the LTC population.

Clinical Technician Role

Our pharmacy was previously utilizing the pharmacist for almost all aspects of completing a CMR. Now, with the exception of actually performing the CMR and creating the patient action

plan materials, our Clinical Technician performs all duties related to the CMR. The technician reviews for insuranceidentified patients (i.e. pushes) by regularly monitoring CMR platforms such as Mirixa, Outcomes, and ForwardHealth (WPQC). WPQC billing opportunities are often much more flexible than other programs and make it easier to provide patients and caregivers the coaching they need. Without regularly monitoring these pushes, CMR services can be taken over by another provider, and the opportunity is lost despite being the patient’s primary pharmacy. In addition, the Clinical Technician obtains prior authorizations, contacts patients or power of attorneys, schedules the CMR with an available pharmacist, bills for the CMR, and sends out the printed action plan materials.

CMRs in the LTC Setting

Many pharmacies assume performing CMRs is only for the community pharmacy patient, but patients residing in assisted living facilities (ALFs) are also eligible for this service. Many ALFs do not have nurses available, and they rely heavily on the pharmacy for medication and disease state information. Performing CMRs provides valuable information to the ALF staff to aid in patient monitoring and setting patient-specific goals. Our

experience with providing CMRs to ALF patients has been very positive. Patients, family members and staff have all provided positive feedback. We even received a request from one ALF staff member to perform a CMR for all of her residents. Appointments are often set up within the pharmacy, while others are set up at the facility. When going out to a facility, our Clinical Technician tries to schedule multiple CMRs back to back at the facility to optimize the pharmacist’s time. In addition, this service has helped improve our relationship with staff and caregivers at these facilities by providing a personalized touch with face-to-face encounters.

Initial Results

Since implementation, our staff has performed over 60 CMRs for ALF patients during the current calendar year. Out of these 60 CMRs, over 80 interventions have been suggested to medical providers and over 65% of our interventions have resulted in an affirmative response to the intervention suggested (see Table 1). A review of our financials has shown no additional dollars allocated to pharmacist labor for performing these CMRs. In addition, our pharmacists have felt more rewarded being able to utilize their clinical expertise on a more regular basis. One example included a CMR with a patient

TABLE 1. Comprehensive Medication Reviews Total Number of CMRs Performed in ALF

Number of Interventions Suggested by Pharmacist

Number of Interventions Approved by Prescriber

% Rate of Approval

60

81

53

65.40%

CMR: Comprehensive Medication Review; ALF: Assisted Living Facilities

20  The Journal

November/December 2019

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and his caregiver. The patient had a recent hemoglobin A1c (HgA1c) of 13%. During the CMR, it was identified that the patient was not using his insulin appropriately and was consuming up to five cans of sugar soda in a day. This patient met with us again at a follow up CMR after roughly ninety days and we were happy to report a decrease in his HgA1c. Being able to positively affect patients in this way makes the experience worthwhile.

Conclusion

There may always be barriers to performing CMRs. However, having a Clinical Technician lead the charge to overcome many of these barriers has been instrumental in our success. Many pharmacies focus only on pushes from the national platforms and often underutilized WPQC opportunities. Leveraging a technicians’ skills to ascertain a patient’s

need for CMR services while maximizing the use of all billable platforms has greatly expanded our number of CMR opportunities. Additionally, the unique expansion of our CMR program to the ALF has begun to produce positive outcomes in medication and disease state management, and create relationships with ALF staff and caregivers. Nicole Schreiner is the owner of Streu's Pharmacy in Green Bay, WI. Taylor Millar is a 2nd Year Doctor of Pharmacy Candidate at Concordia University Wisconsin in Mequon, WI. Gabrielle Gaura is a Pharmacy Technician at Streu's Pharmacy in Green Bay, WI. Disclosures: The authors declare no real or potential conflicts or financial interest in any product or service mentioned in the manuscript, including grants, equipment, medications, employment, gifts, and honoraria.

Updated Toolkit Webinars COMING SOON! Updated webinars for the Anticoagulation, Hyperlipidemia and Diabetes toolkits will be available for CE credit soon. Watch for an announcement in FastFacts or on the PSW website.

Below: Streu's Pharmacy WPQC Certified Pharmacists. From left to right: Andrew Saether PharmD, Matt Ansay PharmD, John Lemke PharmD, and Nicole Schreiner PharmD

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November/December 2019

The Journal 21


Review Article

Writing Club

UNIVERSITY OF WISCONSIN-MADISON SCHOOL OF PHARMACY STUDENT WRITING CLUB:

Changing Landscapes in Pediatric Food Allergy Prevalence by Denise Garner, 2022 PharmD Candidate, Sarah Parbs, 2022 PharmD Candidate, Cassie Sedgwick 2021 PharmD Candidate, Sam Tran, 2021 PharmD Candidate

P

ediatric food allergies in America are on the rise, leaving many wondering why this is the “new normal� for some families. In the past decade, it is estimated that general food allergies have increased by 18% and peanut allergies by 80%.1 The current primary literature has identified the negative social, economic, and physiological effects food allergies have on patients and their families. This presents the field of pharmacy with unique opportunities to conduct research, administer and counsel on treatments, be resources to families, and play supportive roles in hopes to improve the quality of life for individuals experiencing food allergies. Collaborative referrals explained in this review between pharmacists and other healthcare professionals have the potential to help families navigate the healthcare system. This manuscript aims to connect the current literature on allergy management and the social, economic, and physiological burdens it has on the children and families with the value of incorporating pharmacists more frequently in allergy treatment.

A Rising Problem

There are many factors that contribute to the rise of food allergies. The human microbiome has changed with the development of Western medicine and decline of microorganism exposure. The hygiene hypothesis postulates these 22  The Journal

November/December 2019

microorganisms may be necessary to prevent the development of allergies.2 Furthermore, the food we eat is riddled with additives, livestock animals are exposed to hormones and antibiotics, and the environment has become polluted, which all have the potential to play a role in allergy development.2 It has also been noted that certain medications like acid suppressors such as proton pump inhibitors have high potential of being risk factors for food allergy development.3 Another reason why allergies may be increasing is lack of public education on the difference between food intolerance and food allergy.4 A food intolerance is usually less severe and typically only leads to digestive issues whereas a food allergy elicits an immune response. It is challenging for patients to make this distinction which has led to reports of food allergies as high as four times greater than actual allergy prevalence. For many years, allergists were urging patients to avoid potential allergens at a young age in order to prevent the development of an allergy. The Immune Tolerance Network conducted a study called Learning Early about Peanut Allergy (LEAP) that suggests otherwise.5 In a randomized study, 530 children ranging from four to eleven months old were identified to be at high risk for developing a peanut allergy. Half of the participants avoided peanuts until the age of five and half frequently consumed peanuts. Among the participants who withheld peanut

consumption, 13.7% developed a peanut allergy and only 1.9% of those exposed to peanuts developed the allergy (p<0.001).5 The Immune Tolerance Network now suggests that normal consumption of peanuts throughout pregnancy could build protective immunity rather than allergic reaction.6 This study suggests that avoidance of peanut consumption may not be necessary and could have contributed to the doubling in allergies in the last ten years.5

Social and Economic Burdens A rise in allergies correlates to a significant cost burden. Of the 5.9 million children affected by allergies, the estimated cost in 2011 was $24.8 billion or around $4,184 per child.6 Literature also suggests a large cost difference between the lowest and highest income stratum.6 The lowest income bracket spent more than two times the amount on emergency care and hospitalizations compared to the highest income bracket. Transversely, the highest income bracket spent more on specialist visits and out-of-pocket medications compared to the lower income counterpart.6 High income families spent more on preventative medication while lower income families spent more money on treating acute preventable anaphylactic events.6 Allergy treatment gaps also exist between ethnic groups. African-American www.pswi.org


and Asian children are more likely to have a food allergy compared to Caucasian children; they are also less likely to be diagnosed in the clinical setting.7 These trends explain how groups of children living with a food allergy could be disproportionately financially impacted due to high healthcare costs. Beyond direct healthcare costs, families incur additional expenses associated with pediatric food allergies. A 2018 study reported that 20% of families with a food allergy also experience food insecurity, which is the inability to provide nutritional requirements due to financial restraint.8 This restraint makes the daily task of providing specialty allergen-free food a challenge. Beyond physical symptoms, families tracking food allergies must monitor the cross contamination of utensils, appliances, and food at home.9 In some situations parents lose opportunities at work, need to take time off of work, arrange expensive specialty childcare, or even lose jobs due to severe allergy cases.6 Pharmacists who identify families with financial constraint can provide information on resources for food allergy management. Pharmacists who see patients frequently can coordinate a warm handoff to a social worker or medication access team. A warm handoff intervention is a referral where the patient is guided through the referral process between two healthcare providers according to the Agency for Healthcare Research and Quality.10 A warm handoff in the pharmacy would consist of a pharmacist calling a specific service and helping the patient make an appointment. Free materials and handbooks to support implementation of warm handoffs in healthcare can be found on the agency’s website.10 Free financial tips are also found on Food Allergy Research & Education (FARE) website.11 When communicating with families in high financial need, pharmacists can discuss topics found on the FARE website such as insurance appeal information for high cost epinephrine, understanding insurance denial of coverage, tips on manufacturer cost saving programs, and navigating food assistance programs for a child with food allergies.11

Psychological Burdens Stress associated with allergy

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symptoms can cause parents a great deal of psychological burden, especially during early childhood, a time where they are responsible for a majority of allergy avoidance.9 About half of parents with young children will restrict social activities, avoid restaurants, and reduce work hours to compensate for potential allergic reactions while still promoting their child’s psychosocial development.9 Physiological parameters surrounding families taking care of a child with food allergies are measured quantitatively through Health Related Quality of Life (HRQOL).12 HRQOL is decreased because of heightened anxiety in both parents and children surrounding food allergy management.12 While these results do not suggest a purely causal relationship, they showcase the complexity of childhood allergies.13 As children move through school age and adolescence, allergy management and awareness slowly transitions from the parent to child responsibility. Clinical guidelines state that children start to change thought processes surrounding risk and safety around eight to nine years old.9 In a study examining allergy-affected children in Italy who were referred to a psychological treatment center, 40% of appointments addressed excessive anxiety, stress, and social isolation.14 Throughout the day, a child with a food allergy must comprehend the importance of carrying epinephrine with them at all times and be comfortable with administering it. Some children may have anxiety surrounding a past anaphylactic event, while others may find carrying epinephrine to be burdensome. It is important for members of the child’s care team to assist with connecting children with appropriate psychological resources when indicated. Similar to warm handoff utilization mentioned for financial resources, a clinical or community pharmacist can implement a similar model of referring patients to psychological services.10 If referrals are not possible in a particular practice site, pharmacists can refer patients to free support groups.10 For example, the FARE website lists contact information for various regional groups within each state in which patients can reach out to for allergy management support.10

Pharmacist’s Presence within Schools Another angle pharmacists can leverage healthcare connections is within schools. Pharmacist education to school staff and nurses could provide valuable guidance in identifying anaphylactic symptoms and epinephrine administration. The National Education Association recommends school districts to provide epinephrine as the drug treatment of choice for anaphylactic events.15 Wisconsin School Health services have recommended school districts to provide yearly training on food allergies and epinephrine use to all school staff and school districts to provide instructions on using epinephrine auto-injectors.15 An allergic event can happen to anyone. According to the Massachusetts School District, 22.6% (n=122) adults and children who received epinephrine had no previous diagnosis of food allergy.16 Many schools implement peanut-free lunch tables and classrooms. This precaution does not, however, eliminate the potential for a stressful allergic episode.17 Furthermore, accidental reactions have occurred in up to 50% of food-allergic children in schools despite efforts in strict avoidance policies.18,19 In a recent survey of school nurses in Minnesota, 90.3% of nurses reported that a pharmacist could assist them with medication management.20 To successfully manage these procedures, a registered nurse is employed to conduct and supervise school health programs while working alongside a medical advisor.17 The collaboration between the school nurse and medical advisor, such as a pharmacist or family practitioner, must develop an individualized health plan for each child with a diagnosed allergy that addresses allergen avoidance and emergency preparedness.17 One study found decreased epinephrine presence in urban schools with low socioeconomic status (SES) and limited English proficiency populations.21 Epinephrine access is essential in immediate treatment of anaphylactic episodes. This data suggests an opportunity for pharmacist intervention through educating school nurses on the importance of increasing accessibility of epinephrine autoinjectors. November/December 2019

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Changing Landscapes: Prevention and Treatments Recent research in allergy treatment suggests the incorporation of new immunotherapies, including epicutaneous patches, which may be available behind the pharmacy counter someday.22 Oral, epicutaneous, and sublingual immunotherapies are the main ways researchers are trying to treat these allergies. Desensitization is the mechanism of oral immunotherapy. In these studies children were exposed to very small amounts of peanut at a time and slowly increased the threshold of peanuts that they could ingest.22 Oral immunotherapy requires patients to consume the food protein mixed with a vehicle such as applesauce or pudding; it is one of the most widely studied therapies.22 Compiled results from a group of studies of oral immunotherapy resulted in 70 to 90% desensitization of patients.22 Researchers have also identified epicutaneous immunotherapy as another potential treatment for patients. This differs from oral immunotherapy in that the patient receives the same dose of the food through a patch applied daily. Studies for the patch are currently being conducted with peanut, egg, and milk allergens.22 This patch targets the immune cells in the skin, ultimately resulting in desensitization. Sublingual immunotherapy is much like oral immunotherapy, where the patient is given a small amount of the allergen as a liquid, which is held under the tongue and then swallowed.1 A long-term study was conducted in which 98% of doses given were tolerated by the patient resulting in fewer side effects; however, the results of the therapy were not statistically significant in regards to classifying sublingual immunotherapy as effective.23 Research is also being conducted on targeting specific proteins in food that elicit severe responses.23 For instance, the Ara h2 protein in peanuts stimulates an Immunoglobulin E response in many patients with peanut allergy.23 If scientists were able to modify this protein and make it less recognizable to the bodies immune system, they could potentially lessen or eliminate an allergic reaction. Continual research in desensitization and protein 24  The Journal

November/December 2019

specification lend to a promising future on the treatment of food allergies. Pharmacists’ awareness and involvement in research of new immunotherapy treatments is essential to assisting patients in understanding current and future medication options.

for pharmacists to work with patients and providers in long-term management of anaphylaxis.25 Overall, pharmacists are integral in identifying gaps in anaphylaxis treatment and educating patients on epinephrine auto-injector use.

Optimizing Pediatric Epinephrine Counseling

Conclusion

As pharmacists continue to expand their role within disease management, another potential practice area is integration into pediatric allergy treatment. Pharmacists are currently responsible for dispensing epinephrine injections and educating the patients and parents on how to properly use the injectors. When an epinephrine auto-injector is first prescribed, education by providers to patients is either incomplete (60.7%) or absent (16.3%).24 In addition, when a patient or parent goes to fill the prescription at a pharmacy for the first time, pharmacists only give training on how to use the auto-injector about 13% of the time.24 This is despite most patients wanting to receive regular reviews of how to administer the medication at the time of refill (79.3%).24 Many patients who are picking up a new auto-injector may be doing so because the previous one expired. A patient could go years without needing to use their epinephrine, so it may be difficult to recall how to use it. Pharmacists should review auto-injector techniques during each consultation due to slight differences between products and brands and to assess patient knowledge on epinephrine use. Pharmacists are successful in identifying epinephrine auto-injector candidates by reviewing electronic medical records.25 Since allergy history is gathered in community, primary care, and hospital settings, pharmacists in both inpatient and outpatient settings could identify patients currently at risk for anaphylaxis without an auto-injector. Up to 52% of patients who have a history of anaphylaxis never receive a prescription from their provider for an epinephrine auto-injector and 60% percent of patients do not currently have an injector available to them.26 A pilot program at Catholic Charities Free Health Care Center suggested that as pharmacists gain more access to electronic medical records, there will be more opportunities

Right now, pharmacists are involved in pediatric allergies through consultation, advising on the signs of anaphylaxis, and demonstrating proper administration of epinephrine auto-injectors. However, with the rise of pediatric allergies, there are many more opportunities for pharmacists to get involved. Pharmacists are a great resource to school systems, school nurses, and staff because they have the ability to provide education. Being one of the most accessible healthcare providers in the nation, pharmacists have constant patient interaction. They are able to identify gaps in care and through optimizing epinephrine counseling and warm handoff implementation. Pharmacist referral to free online resources such as FARE give patients another place to seek information and support for allergy management, support groups, and financial tools. In the future, pharmacists could have the opportunity to counsel on immunotherapies that are currently still in clinical trials. The future looks promising for the involvement of pharmacists in pediatric allergy intervention. As pediatric food allergies remain a prevalent problem in our society, pharmacists continue to be a quintessential piece in the healthcare team. Denise Garner and Sarah Parbs are 2nd Year Doctor of Pharmacy Candidates and Cassie Sedgewick and Sam Tran are 3rd Year Doctor of Pharmacy Candidates at the University of Wisconsin-Madison School of Pharmacy in Madison, WI.

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This article has been peer-reviewed. The contribution in reviewing is greatly appreciated!

Acknowledgement: The authors would like to acknowledge Nicholas Zetes, PharmD, Outpatient Pharmacy Coordinator-American Family Children’s Hospital Outpatient Pharmacy, for his support and guidance in writing this article. www.pswi.org


Disclosures: The authors declare no real or potential conflicts or financial interest in any product or service mentioned in the manuscript, including grants, equipment, medications, employment, gifts, and honoraria.

References

1. Sharma HP, Herbert LJ. Food allergy: psychosocial impact and public policy implications. Chem Immunol Allergy. 2015;101:221-226. 2. Spechler SJ. Speculation as to why the frequency of eosinophilic esophagitis is increasing. Curr Gastroenterol Rep. 2018;20(6):26. 3. Untersmayr E. Acid suppression therapy and allergic reactions. Allergo J Int. 2015;24(8):303-311. 4. Hadley C. Food allergies on the rise? Determining the prevalence of food allergies, and how quickly it is increasing, is the first step in tackling the problem. EMBO Rep. 2006;7(11):1080-1083. 5. Du Toit G, Roberts G, Sayre PH, et al. Randomized trial of peanut consumption in infants at risk for peanut allergy. N Engl J Med. 2015;372(9):803-813. 6. Gupta R, Holdford D, Bilaver L, Dyer A, Holl JL, Meltzer D. The economic impact of childhood food allergy in the United States. JAMA Pediatr. 2013;167(11):1026-1031. 7. Esteban CA, Klein RB, Kopel SJ, et al. Underdiagnosed and undertreated allergic rhinitis in urban school-aged children with asthma. Pediatr Allergy Immunol Pulmonol. 2014;27(2):75-81. 8. Tackett AP, Farrow ML, Mcquaid EL. Food security, utilization of food assistance programs, and caregiver perceptions of food-induced anaphylaxis risk in children with food allergies. Pediatr

www.pswi.org

Allergy Immunol Pulmonol. 2018;31(2):91-96. 9. Herbert LJ, Mehta P, Sharma H. Mealtime behavior among parents and their young children with food allergy. Ann Allergy Asthma Immunol. 2017;118(3):345-350. 10. Warm handoff: Intervention. Agency for Healthcare Research and Quality. ahrq. gov/. Accessed October 7, 2019. 11. Food Allergy Research & Education® (FARE). https://www.foodallergy. org/. Accessed October 7, 2019. 12. Roy KM, Roberts MC. Peanut allergy in children: relationships to health-related quality of life, anxiety, and parental stress. Clin Pediatr. 2011;50(11):1045-1051. 13. Cortes A, Castillo A, Sciaraffia A. Food allergy: children’s symptom levels are associated with mothers psycho-socio-economic variables. J Psychosom Res. 2018;104:48-54. 14. Polloni L, Baldi I, Lazzarotto F, et al. School personnels self-efficacy in managing food allergy and anaphylaxis. Pediatr Allergy Immunol. 2016;27(4):356-360. 15. Blom M, Carr B, Creasy M, et al. Food allergies: managing and preventing acute reactions in the school setting. Wisconsin Health Services Project. www.wpha.org/school-health. Published 2013. Accessed October 7, 2019. 16. Mcintyre CL, Sheetz AH, Carroll CR, Young MC. Administration of epinephrine for life-threatening allergic reactions in school settings. Pediatrics. 2005;116(5):1134-1140. 17. American Academy of Pediatrics Council on School Health, Magalnick H, Mazyck D. Role of the school nurse in providing school health services. Pediatrics. 2008;121(5):1052-1056.

18. Bock S, Atkins F. The natural history of peanut allergy. J Allergy Clin Immunol. 1989;83(5):900-904. 19. Reutzel TJ, Rafinski M, Dang T, Nithyanandam L. Medication management in primary and secondary schools: assessing the knowledge and opinions of parents. J Am Pharm Assoc. 2009;49(3):417-422. 20. Little MM, Eischens S, Martin MJ, et al. Medication management in Minnesota schools: the need for school nurse–pharmacist partnerships. J Am Pharm Assoc. 2018;58(1):67-72. 21. Davis C, Parker C, Shah S. Under-recognition of food allergies in lower socioeconomic status (SES) schools in a large urban school district. J Allergy Clin Immunol. 2011;127(2). 22. Anvari S, Anagnostou K. The nuts and bolts of food immunotherapy: the future of food allergy. Children. 2018;5(4):47. 23. Yu W, Freeland DMH, Nadeau KC. Food allergy: immune mechanisms, diagnosis and immunotherapy. Nat Rev Immunol. 2016;16(12):751-765. 24. Barnett CW. Need for community pharmacist–provided food-allergy education and autoinjectable epinephrine training. J Am Pharm Asso. 2005;45(4):479-485. 25. Stewart A, Sulkowski K. Pharmacist use of the electronic medical record to identify adults at risk for anaphylaxis without epinephrine for self-administration. J Am Pharm Asso. 2017;57(3): 369-374. 26. Wood RA, Camargo CA, Lieberman P, et al. Anaphylaxis in America: the prevalence and characteristics of anaphylaxis in the United States. J Allergy Clin Immunol. 2014;133(2):461-467.

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Original Work

Pharmacist Managed Warfarin Dosing Using Chromogenic Factor X Assay During Direct Thrombin Inhibitor Overlap Therapy by Riley C.J. Poe, PharmD, Kasey L. Davis, PharmD, BCPS, Frank C. Spexarth, RPh, BCPS, Federico A. Sanchez, MD

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he vast majority of patients requiring anticoagulation with direct thrombin inhibitors (DTIs) and warfarin overlap therapy will be patients with a history of heparininduced thrombocytopenia (HIT) or an acute HIT diagnosis. HIT is a lifethreatening, immunologically mediated adverse drug reaction to heparin containing products with a prevalence ranging from 0.1-5% of patients receiving heparin. Additionally, HIT causes a hypercoagulable state and approximately 35-50% of patients with HIT will develop thrombosis.1 Due to the high risk for thrombosis, immediately upon clinical suspicion for HIT, all heparin containing products should be discontinued and initiation of non-heparin parenteral anticoagulants is recommended.2 Further laboratory evaluation for a HIT diagnosis includes a positive platelet factor 4 (PF4) and a positive serotonin release assay (SRA), along with a clinical assessment and diagnosis from a physician, ideally a specialist in hematology. The most commonly used and FDA approved parenteral anticoagulant for the treatment HIT is the DTI argatroban. While not FDA approved specifically for HIT, bivalirudin is a DTI that has been shown to effectively treat HIT.2 Both of these medications, especially argatroban, prolong the prothrombin time in a dose-related manner which results in an elevated international normalized ratio (INR).2 This false elevation in INR makes it challenging to determine the appropriate time to discontinue the DTI infusion and transition to warfarin alone at goal INR. Direct thrombin inhibitor infusions are started and continued alone in patients with acute HIT until platelets have substantially recovered to at least 100-150x109/L.2 After platelet

26  The Journal

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Abstract Objective: To compare patients transitioned from direct thrombin inhibitor (DTI) to warfarin using INR versus chromogenic factor X (CFX) assay after the creation and implementation of a pharmacist managed CFX protocol. Methods: Encounters of patients who received argatroban or bivalirudin at our institution between June 1, 2017 and June 30, 2018 were screened for inclusion through retrospective chart review. Individual patient encounters were included if they had overlapping therapy with a DTI and transitioned to anticoagulation with warfarin alone. Post intervention patients were identified from October 1, 2018 through June 13, 2019 using the same inclusion criteria. They were monitored by the established pharmacist protocol using a CFX levels during the transition from DTI to warfarin. Results: Ahe pre-intervention group included 18 encounters (17 argatroban, 1 bivalirudin) and the post intervention group included 17 encounters (16 argatroban, 1 bivalirudin). The percent therapeutic confirmatory INR was similar in the two groups (44% in the preintervention group and 71% in the post intervention group, P = 0.12). However, median days of warfarin and DTI overlap was significantly higher in the pre-intervention group than in the post intervention group (6.5 days vs. 5 days P = 0.04). No adverse events were observed in either group. Conclusions: CFX offers a potentially effective alternative method to assess anticoagulation status in patients transitioning from DTI to warfarin. Using CFX may result in a higher percentage of therapeutic INRs compared to monitoring INRs alone and decreased length of overlap therapy.

recovery, per current guidelines, warfarin is recommended to be started and overlapped with a non-heparin parenteral anticoagulant for a minimum of 5 days. The INR should then be rechecked after the anticoagulant effect of the nonheparin anticoagulant has dissipated and a confirmatory INR should be drawn.2 The negative consequences associated with the narrow therapeutic

index of warfarin and hypercoagulable state of HIT add to the complexity of deciding when to discontinue parenteral anticoagulation and continue with warfarin anticoagulation alone. On one hand, clinicians may risk underdosing and an increased risk of thrombosis, and on the other hand, they may risk overdosing and an increased risk of bleeding making this clinical scenario particularly difficult to www.pswi.org


manage. Although some efficacy and safety data is available for use of the direct oral anticoagulants (DOACs) in acute HIT, the limited evidence makes warfarin the preferred oral anticoagulant choice for most patients.3 Currently, there is no true standard of practice amongst institutions or clinical practice guideline on the recommended method for transitioning patients from DTI infusions to warfarin. Therefore, health systems around the United States typically manage this transition in one of two ways: 1. Target an INR greater than 4 on overlap therapy with argatroban and warfarin; then argatroban can be discontinued when the INR is greater than 4 with combined therapy. After argatroban is discontinued, repeat the INR measurement in 4-6 hours to ensure INR remains therapeutic. If INR is subtherapeutic, argatroban should be restarted and the process is repeated until a therapeutic confirmatory INR is obtained. This is the present practice at our institution which is consistent with the argatroban package labeling.4 2. Based on an institution specific protocol, use chromogenic factor X assay and target the therapeutic range for CFX of approximately 20-45% while on combined DTI and warfarin therapy.5-7 Once CFX is in therapeutic range, argatroban can be discontinued. Then a confirmatory INR should be measured 4-6 hours after argatroban discontinuation, to ensure that INR is therapeutic. If that INR is less than 2 the argatroban should be restarted and warfarin dose should be increased. The CFX assay measures the amount of factor X activity and is not influenced by the DTI. In the lab, russell viper venom is added to the plasma, which converts only the carboxylated factor X to activated factor Xa. Since warfarin works by inhibiting carboxylation of the vitamin K dependent coagulation factors (II, VII, IX, X) the percentage carboxylated will be lower in a patient taking warfarin. This reaction is then quantified via chromatography and reported as a percentage of factor X activity with a higher percentage correlating with greater factor X activity.8 www.pswi.org

FIGURE 1. Pre-intervention Patient Encounter Inclusion and Exclusion Diagram

Total patient encounters receiving argatroban or bivalirudin (n=212) Excluded encounters (n=194) No warfarin overlap (n=189) Transitioned to another oral anticoagulant (n=3) Switched to another parental anticoagulant (n=2) Included encounters (n=18)

Therefore, the CFX will decrease when patients take warfarin. Published literature supports CFX as an effective alternative to INR, but currently none of the most updated guidelines reviewed suggest using CFX levels. However, the 2008 CHEST guidelines on HIT recommend, “patients receiving argatroban who are being transitioned to a vitamin K antagonist, we suggest that factor X levels measured using a chromogenic assay be used to adjust the dose of the vitamin K antagonist” (Grade 2C).9 Along with that, the 2012 CHEST guidelines on parenteral anticoagulants state that “Because holding argatroban may expose patients to a risk of thrombosis, another option is to monitor the vitamin K antagonist with a chromogenic factor X assay”.10 The primary literature supporting its use is from transitioning patients to warfarin from DTI and also in warfarin monitoring for patients with coagulation abnormalities affecting INR.11,12 This article will describe a quality improvement project that compared patients transitioned from DTIs to warfarin using INRs (pre-intervention) and patients transitioned using CFX levels after the creation and implementation of a pharmacist managed warfarin dosing protocol (post intervention). The primary objective was to compare the difference in therapeutic confirmatory INRs between the pre-intervention group transitioned from DTI to warfarin using INR and the post

intervention group transitioned from DTI to warfarin using CFX. It was hypothesized that a higher percentage of therapeutic confirmatory INRs and a lower number of DTI and warfarin overlap days would be seen in the post intervention group.

Methods

This quality improvement project was reviewed and approved by the Institutional Review Board at Aurora Health Care. All patients who received argatroban or bivalirudin at our institution between June 1, 2017 and June 30, 2018 were identified and screened for inclusion into the pre-intervention group through data available in the electronic health record. Patients were eligible for inclusion if they were at least 18 years of age and had overlapping therapy with a DTI (argatroban or bivalirudin) and warfarin transitioning to warfarin therapy alone. Patients were excluded if argatroban or bivalirudin therapy did not overlap with warfarin, patients were switched to another parenteral agent (e.g heparin or fondaparinux), patients were transitioned from DTI therapy to other non-warfarin oral anticoagulants (e.g. apixaban or rivaroxaban) or if death occurred during the DTI and warfarin overlap time period. The primary outcomes of this project were percentage of therapeutic INRs and days of DTI and warfarin overlap between the two groups. The secondary outcomes November/December 2019

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TABLE 1. Pre and Post Intervention Demographics (n= Number of Patient Encounters) Pre-Intervention (n = 18)

Post Intervention (n = 17)

58.5 (30 - 89)

68 (37 - 85)

Sex Male, N (%)*

13 (72%)

6 (35%)

Race, N (%) White African American Asian

16 (89%) 2 (11%) 0 (0%)

14 (82%) 2 (12%) 1 (5%)

Age, in years, Median (Range)

*Statistically significant difference (p= 0.03)

were INR on DTI therapy alone, INR day of DTI discontinuation, confirmatory INR, percent of subtherapeutic confirmatory INR (<2.0), percent of supratherapeutic confirmatory INR (>3.5), dose of DTI (mcg/kg/min), days of DTI therapy, length of hospital stay from day 1 of overlap (days), number of thrombosis events, number of major bleeding events. The pre-intervention patient group was transitioned from DTI to warfarin using INRs alone with no specific established protocol. The argatroban labeling recommendations for transitioning to warfarin were followed along with health care team’s clinical judgement.4 The process outlined in our institution was to initially target an INR greater than 4 on overlapping therapy with argatroban and warfarin. Argatroban can then be discontinued when the INR is greater than 4 with combined therapy. After argatroban is discontinued, repeat the INR measurement in 4-6 hours to ensure therapeutic INR values. For post intervention patients, an institution specific “Pharmacist Managed Warfarin Dosing Using Chromogenic Factor X Assay During Direct Thrombin Inhibitor Overlap Therapy” protocol was developed. The protocol developed utilizes goal therapeutic CFX levels of approximately 20-40% correlating to an INR of 2.0-3.0 based on the approximate results of previously published literature and incorporates an institution specific warfarin dosing table based on the correlation between CFX and INR.5-7 This protocol was created by pharmacists in collaboration with physicians on the hematology and oncology physician committee for feedback and approval. 28  The Journal

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Education was presented to multiple other physician groups including cardiovascular surgery, critical care, cardiology, as well as clinical pharmacists. Hospitalists and nurse practitioners were educated on the process on a case by case basis. This protocol served as a guideline to manage post intervention patients in this project. Post intervention patients were identified from October 1, 2018 through June 13, 2019. The same inclusion and exclusion criteria described above was used. The post intervention patients were monitored using the established pharmacist managed protocol using CFX levels in combination with the clinical judgement of the healthcare team. For the purposes of this project, a ‘confirmatory INR’ was defined as an INR 4-24 hour after DTI infusion was discontinued and therapeutic INR was defined as 2.0-3.5. The Wilcoxon two-sample test was used for continuous variables and the chisquare or Fisher's exact test was used for categorical variables. Chromogenic factor X assays were performed using a Biophen Factor X Kit on a BCS-BCSXP analyzer by trained laboratory personnel.

Results

During the pre-intervention project period, 212 patient encounters received argatroban (80) or bivalirudin (132) and were screened for inclusion into this group. 192 of those encounters were excluded for the following reasons: no overlap with warfarin or death before DTI discontinuation. The majority of patients were not continued on argatroban or overlapped with warfarin for reasons including: negative PF4 or SRA and switch back to heparin products, short-

term procedural use of DTI, transition to DOAC, transition to fondaparinux or death (Figure 1). The pre-intervention group included 18 encounters (17 argatroban, 1 bivalirudin) and the post intervention group included 17 encounters (16 argatroban, 1 bivalirudin). There were no deaths in either group during warfarin and DTI overlap therapy. The baseline demographic characteristics of patient population are presented in Table 1. Sex between groups was the only identified difference (p= 0.03). The primary outcome of percent therapeutic confirmatory INR was similar between the two groups. (44% in the pre-intervention group and 71% in the post intervention group, p = 0.12). However, median days of warfarin and DTI overlap was significantly higher in the pre-intervention group than in the post intervention group (6.5 days vs. 5 days p = 0.04). No adverse bleeding or thrombotic events were observed in either group. The secondary outcomes of INR day of DTI discontinuation, confirmatory INR, percent of subtherapeutic confirmatory INR, percent of supratherapeutic confirmatory INR, dose of DTI, total days of DTI therapy, length of hospital stay from day 1 of overlap, number of thrombosis events, number of major bleeding events are listed in Table 2. There were no differences between the two groups.

Discussion

To our knowledge, there are no other projects describing the implementation of a pharmacist managed protocol for transitioning patients from DTI to warfarin using CFX. The pre-intervention results of this project were similar to findings in other published literature about using INR to transition patients from argatroban to warfarin. Hursting et al. retrospectively reviewed the outcome of therapeutic confirmatory INR in 108 patients who were transitioned, without specific guidelines or institutional protocols, from argatroban to warfarin therapy using INRs. This study found that 40% (43/108) patients achieved a therapeutic INR after argatroban therapy was discontinued.13 We found similar results to this (44%, 8/18). www.pswi.org


The results demonstrated by the post intervention group in this project show that CFX may be a useful assay for the healthcare team in determining when to discontinue the DTI infusion and have a confirmatory therapeutic INR on warfarin alone. McGlasson et. al, found that CFX was inversely related to and correlated well with INR (R= 0.964).5 The CFX range was 18-48% (mean 28%) for patients with an INR 2.0-3.0 and that CFX yielded a sensitivity of 91.7% and a specificity of 91.9% for discriminating INR of at least 2.0. Their data suggests that the CFX can be a highly discriminative tool for differentiating therapeutic and subtherapeutic INRs in situations where confounders to INR may be present (e.g. DTI and warfarin overlap therapy).5 From this project’s pre-intervention findings as well as the other published literature it is evident that there is an opportunity for process improvement during this clinical scenario. Furthermore, a few previously published articles have described a successful transition from DTI to warfarin using CFX and a relatively high percentage of therapeutic confirmatory INRs.6-7 Arpino et al., conducted a prospective observational analysis in patients transitioning from argatroban to warfarin at their institution where use of CFX is the predominant method for measuring anticoagulation with patients on DTIs.6 The authors found that a CFX level equal to or less than 45%, predicted a confirmatory INR of greater than or equal to 2 with an accuracy of 89%. They also found an average of 6 ¹ 3 doses of warfarin were administered during the overlap period, similar to the results found in this study. Similarly, Austin et al. found a sensitivity of 78.2%, specificity of 77.8% for CFX to accurately predict an INR greater than 2.0 in patients who received the recommended 5 or more days overlap with argatroban and warfarin.7 These prior publications along with the results of this project, suggest that CFX is an accurate alternative method of measuring anticoagulation when converting hospitalized patients from argatroban to warfarin. The clinical significance of increasing the percentage of obtaining therapeutic confirmatory INRs in terms of reducing www.pswi.org

TABLE 2. Primary and Secondary Outcomes Pre-Intervention (n = 18)

Post Intervention (n = 17)

P-value

Therapeutic Confirmatory INR, N (%)

8 (44%)

12 (71%)

0.12

Days of Warfarin and DTI Overlap, Median (Range)

6.5 (3 - 17)

5 (3 - 16)

0.04

4.2 (2.4 - 10.4)

3.5 (2.1 - 12.0)

0.22

2.7 (1.6 - 7.1)

2.2 (1.7 - 4.0)

0.30

3 (17) 8 (44) 7 (39)

3 (18) 12 (71) 2 (12)

Dose of DTI (mcg/kg/min), Median (Range)

0.60 (0.05 - 5.30)

0.50 (0.10 - 5.00)

0.25

Total days of DTI Therapy, Median (Range)

10 (5 - 31)

7 (3 - 23)

0.06

Length of Hospital Stay from Day 1 of Overlap, Median (Range)

15 (6 - 52)

8 (4 - 56)

0.07

Thrombosis Events, N (%)

0 (0)

0 (0)

N/A

Major Bleeding Events, N (%)

0 (0)

0 (0)

N/A

Primary

Secondary INR Day of DTI Discontinuation, Median (Range) Confirmatory INR, Median (Range) Confirmatory INR Group, N (%) Subtherapeutic (<2.0) Therapeutic (2.0 - 3.5) Supratherapeutic (>3.5)

adverse events is difficult to ascertain from a small population size. However, it can be hypothesized that the risk of bleeding events from supratherapeutic INRs as well as risk of thrombotic events from subtherapeutic INRs can be decreased by obtaining a therapeutic confirmatory INR, like any other disease state that requires anticoagulation with warfarin. Beyond patient safety and efficacy benefits, a therapeutic confirmatory INR will likely also decrease the medication cost of argatroban due to less days of overlap therapy and decrease hospital length of stay. Patients with subtherapeutic confirmatory INRs likely need to remain hospitalized and restart the argatroban resulting in an increased length of stay and increased drug costs. While patients with supratherapeutic INRs after argatroban discontinuation will not need to restart the infusion, they will have received longer than necessary DTI therapy and may require increased monitoring for signs of bleeding which can result in increased hospitalization. It is important to remember laboratory

0.36

interaction and false elevation in INR is directly related to the argatroban dose. Patients on lower doses of argatroban (typically <1 mcg/kg/min) will likely have less INR elevation than patients on higher doses. So waiting for co-therapy INR is 4.0 or greater may result in prolonged argatroban use and a supratherapeutic INR once the argatroban is discontinued. Furthermore, the FDA package labeling for argatroban dosing was derived from healthy patients in an outpatient setting and may not necessarily be representative of the effect of argatroban in hospitalized patients with other significant comorbidities. Much published literature has described the value of pharmacists in the inpatient setting through integration and collaboration of pharmacists within the healthcare team and has demonstrated optimization of patient care. Specifically, for anticoagulation with direct thrombin inhibitors, Lobo et al. demonstrated significantly improved patient care. Results included fewer dosing errors, fewer bleeding events, and improved November/December 2019

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documentation when pharmacists were more involved and managed DTIs for patients with HIT through a pharmacistmanaged protocol.14 Their findings suggest that the combination of a pharmacist’s skillset and set protocols can benefit patient care. The intent of this project was to improve patient care by implementing a pharmacist managed warfarin dosing protocol for patients transitioning from DTI to warfarin using CFX. Overall, physicians at our institution agreed that transitioning patients from argatroban to warfarin presents a challenging clinical situation and were in full support of a pharmacist managed warfarin dosing protocol utilizing CFX to monitor these patients. In addition, there was overwhelming support from the hematology/oncology physician committee to include pharmacists in the role of managing the transition in collaboration with the consulting physician. This quality improvement project was not without limitations in project design, patient population and implementation challenges. First, it is important to recognize that there are many confounding variables that happen over the course of a hospitalization that could have impacted results which were outside the scope of this project. Second, there was a small patient population and relatively short length of data collection period in both the pre and post intervention groups. Third, CFX assay was a send-out lab with a turnaround time was approximately 18 hours, potentially leading to continuing the DTI infusion for longer than necessary until the CFX level resulted.

Conclusion

Using only INRs during the DTI and warfarin overlap period does not result in achieving a confirmatory therapeutic INR in most patients and room for improvement in this process exists. It appears CFX offers an effective alternative to clinicians transitioning patients from argatroban to warfarin that may result in a greater percentage of therapeutic confirmatory INRs and decreases days of overlap therapy. Future studies are necessary to further evaluate the clinical usefulness, cost effectiveness and patient safety benefits of using CFX 30  The Journal

November/December 2019

as an alternative to INR to measure the anticoagulation effects of warfarin when transitioning patients from argatroban to warfarin. Riley Poe is a PGY-1 Pharmacy Resident at Aurora Heath Care Metro in Milwaukee, WI. Kasey Davis is a Clinical Pharmacist at Aurora St. Luke's Medical Center in Milwaukee, WI. Frank Spexarth is a Pharmacy Clinical Coordinator—Cardiac Surgery/Cardiology at Aurora Health Care Pharmacy Department in Milwaukee, WI. Federico Sanchez is the System Medical Director, Medical Oncology at Aurora

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This article has been peer-reviewed. The contribution in reviewing is greatly appreciated!

Cancer Center in Milwaukee, WI. Acknowledgements: The authors would like to thank Sandy Korman, senior biostatistician, for her assistance with statistical analysis.

of international normalized ratio for monitoring warfarin therapy in patients with lupus anticoagulant. Pharmacotherapy. 2004;24(7):838-42. 9. Hirsh J, Bauer KA, Donati MB, et al. Parenteral anticoagulants: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition). Chest. 2008;133(6 Suppl):141S-159S. 10. Garcia DA, Baglin TP, Weitz JI, Samama MM. Parenteral anticoagulants: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012;141(2 Suppl):e24S-e43S. 11. Crowl A, Schullo-feulner A, Moon JY. Warfarin monitoring in antiphospholipid syndrome and lupus anticoagulant. Ann Pharmacother. 2014;48(11):1479-83. 12. Moll S, Ortel TL. Monitoring Warfarin Therapy in Patients with Lupus Anticoagulants. Ann Intern Med. ;127:177–185. 13. Hursting MJ, Lewis BE, Macfarlane DE. Transitioning from argatroban to warfarin therapy in patients with heparin-induced thrombocytopenia. Clin Appl Thromb Hemost. 2005;11(3):279-87. 14. Lobo, B., Finch, C. K., Howard-Thompson, A., & Gillion, A. (2010). Pharmacist-Managed Direct Thrombin Inhibitor Protocol Improves Care of Patients with Heparin-Induced Thrombocytopenia. Hospital Pharmacy, 45(9), 705–711.

Disclosures: The authors declare no real or potential conflicts of financial interest in any product or service mentioned in the manuscript, including grants, equipment, medications, employment gifts, and honoraria.

References

1. Salter BS, Weiner MM, Trinh MA, et al. Heparin-Induced Thrombocytopenia: A Comprehensive Clinical Review. J Am Coll Cardiol. 2016;67(21):2519-32. 2. Linkins LA, Dans AL, Moores LK, et al. Treatment and prevention of heparin-induced thrombocytopenia: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012;141:e495S-e530S. 3. Warkentin TE, Pai M, Linkins LA. Direct oral anticoagulants for treatment of HIT: update of Hamilton experience and literature review. Blood. 2017;130(9):1104-1113. 4. Argatroban [package insert]: Research Triangle Park, NC. GlaxoSmithKline, 2012 5. Mcglasson DL, Romick BG, Rubal BJ. Comparison of a chromogenic factor X assay with international normalized ratio for monitoring oral anticoagulation therapy. Blood Coagul Fibrinolysis. 2008;19(6):513-7. 6. Arpino PA, Demirjian Z, Van cott EM. Use of the chromogenic factor X assay to predict the international normalized ratio in patients transitioning from argatroban to warfarin. Pharmacotherapy. 2005;25(2):157-64. 7. Austin JH, Stearns CR, Winkler AM, Paciullo CA. Use of the chromogenic factor X assay in patients transitioning from argatroban to warfarin therapy. Pharmacotherapy. 2012;32(6):493-501. 8. Rosborough TK, Shepherd MF. Unreliability www.pswi.org


Specializing in certifying pharmacy technicians because patient safety matters. Choose PTCB. Choose Excellence.

ptcb.org www.pswi.org

November/December 2019

The Journal 31


Original Work

Improving Immunization Rates in Long-Term Care Facilities: A Pilot Study by Alexandra M Vecchia, 2020 PharmD Candidate, Lindsey C Skubitz, 2020 PharmD Candidate, Courtney J McGee, 2020 PharmD Candidate, Matthew K Tourdot, 2020 PharmD Candidate, Herolind Jusufi, 2020 PharmD Candidate, Kristin K Niemi, 2020 PharmD Candidate

E

very year, patients in longterm care (LTC) and nursing home facilities fail to receive vaccinations for which they are eligible. These vaccinations provide protection against diseases including influenza, pneumonia, and shingles, which can all have a profound impact on the LTC population and lead to hospitalizations and increased healthcare spending. In the United States, pneumococcal infections alone result in more than 240,000 hospitalizations of older adults each year.1 This number is expected to increase dramatically as the population ages. Ensuring that older adults receive indicated vaccinations can help prevent these hospitalizations and cut costs. However, immunization rates in Wisconsin are below national goals set by Healthy People 2020 despite current efforts of pharmacists across the spectrum of the healthcare system.2 Specifically, only 40% of Wisconsin residents received an influenza vaccination during the 20182019 season, which is far below the goal of 70% for noninstitutionalized adults.3 Additionally, only about 58% of patients over the age of 65 had received a dose of pneumococcal polysaccharide vaccine in Wisconsin according to 2018 data.4 Pharmacists are an essential member of the

32  The Journal

November/December 2019

healthcare team when it comes to meeting these immunization targets, and they can play a vital role in increasing immunization coverage in the LTC population. This article describes the workflow of a new, pharmacy-led initiative to increase vaccination rates in LTC facilities served by an independent LTC pharmacy in Wisconsin. Additionally, results from a small pilot study are presented. The goals of this initiative are three-fold: 1) increase vaccination screening in patients 50 years and older residing in LTC facilities, 2) improve immunization rates in this patient population, and 3) increase awareness in patients and providers of the role of a pharmacist.

Background

This new program was developed in coordination with an independent LTC pharmacy located in Wisconsin. The pharmacy serves over 30 skilled and non-skilled assisted living facilities, and it offers a multitude of services including medication therapy management, pill packaging, and psychotropic medication reviews for all facilities. Prior to this pilot study, the pharmacy held an annual influenza clinic at each LTC facility. However, screening patients for eligibility for other vaccinations was

not included in the pharmacy’s regular workflow. Expanding the current annual influenza clinic to include screening for other vaccines would ensure patients are protected against the broad array of preventable diseases.

Methods

The immunization program consists of six steps: screen patients for vaccine eligibility using the Wisconsin Immunization Registry (WIR), obtain consent from the patient to receive the vaccines, submit the vaccines for reimbursement, administer the vaccinations, update the patient’s profile in the WIR, and notify the patient’s primary care provider. To assess the feasibility of this program, a pilot study was conducted. The pilot study consisted of screening all patients at one non-skilled nursing facility during April 2019. The workflow of the immunization program is described in detail below. Screen for Eligibility Prior to the annual influenza clinics held by the LTC pharmacy at each of the contracted LTC facilities, the pharmacy intern will screen each patient for vaccine eligibility using the WIR. Vaccines included in the screening are tetanus, diphtheria, and www.pswi.org


TABLE 1. Vaccine Recommendations Made for Patients at One Non-skilled Nursing Facility n (%) Vaccine Recommendations

RZV

Td

Tdap

PCV13

PPSV23

Influenza

13 (100%)

5 (38%)

2 (15%)

2 (15%)

3 (23%)

0 (0%)

Number and percent of patients for which vaccine recommendations were made. Thirteen of the 15 LTC patients were included in the pilot study based on criteria of being over the age of 50 and having a profile in the WIR. RZV: recombinant zoster vaccine; Td: tetanus and diphtheria; Tdap: tetanus, diphtheria, and pertussis; PCV13: pneumococcal conjugate; PPSV23: pneumococcal polysaccharide.

pertussis (Tdap), tetanus and diphtheria (Td), pneumococcal conjugate (PCV13), pneumococcal polysaccharide (PPSV23), and recombinant zoster (RZV). To assist the intern in the screening process, an “Immunization Screening Flowchart for Patients 50 and Older” was created. This flowchart is designed to walk the intern through inclusion and exclusion criteria for each of the vaccines included in this program. Obtain Consent During the screening process, the pharmacy intern will fill out an “Immunization Recommendations” form. This form includes the name and date of birth of each patient along with the names of the vaccines for which they are eligible. This form will be faxed to a nurse or care coordinator at each of the facilities. A nurse will speak with each patient about the vaccinations and complete the fax form to indicate if the patient accepts or rejects the immunizations. This form will then be faxed back to the pharmacy. Reimbursement A pharmacy technician will submit a claim to the patient’s insurance prior to vaccine administration to be reimbursed for the vaccines. Administration To prevent added burden on the pharmacy, it was determined that the vaccinations would be administered at the annual influenza clinic that is already part of the current workflow. This eliminates additional trips to each LTC facility, which would be unsustainable. Prior to administration, the pharmacist will provide the patient with a Vaccine Information Statement (VIS) for each vaccine. After administering the vaccinations, the pharmacist will complete a “Vaccine www.pswi.org

Administration Record,” which includes the name and date of birth of each patient; name, lot number, and expiration of the vaccine administered; site the vaccine was administered; the date of administration; the date the VIS was published; the date the VIS was provided to the patient; and the initials of the pharmacist administering the vaccinations. Update the Wisconsin Immunization Registry Upon returning from the annual influenza clinic, the pharmacist will provide the pharmacy intern with the “Vaccine Administration Record.” The pharmacy intern will use this information to update each patient’s profile in the WIR. Notify the Primary Care Provider The pharmacy intern will complete a “Vaccination Record” form for each vaccine administered to each patient. The intern will fax this form to the primary care provider to make them aware that the patient has received the vaccines and that the WIR has been updated.

Results

The pilot of the immunization program consisted of screening all patients at one non-skilled nursing facility contracted with the LTC pharmacy. At the time of the pilot, 15 patients were residing in the non-skilled nursing facility. Upon screening for vaccine eligibility, it was discovered that two patients did not have a profile in the WIR. These patients were therefore excluded from the pilot test. The results are presented in Table 1. This pilot study revealed that there is an unmet need for vaccination coverage in this patient population since recommendations were made for all 13 patients that had a profile in the WIR. There were no recommendations made for influenza vaccinations because all patients

had received appropriate vaccinations during the previous annual influenza clinic. A total of 25 vaccine recommendations were made for the 13 residents of the nonskilled nursing facility included in this pilot study.

Discussion

Despite being a high-touch population within the healthcare system, this pilot study indicates that there is a significant gap in vaccination coverage for LTC patients for pneumococcal, zoster, tetanus, and diphtheria. This gap provides ample opportunity for expanding pharmacy services in the elderly population. With margins on dispensing prescriptions shrinking each year, vaccinations have become another way to increase pharmacy revenue. Medicare reimburses vaccines with a favorable margin, which would provide a positive return on investment for pharmacist time and effort to implement a large program across multiple facilities. Merging this new expanded immunization program with the existing fall influenza clinics can help to maximize efficiency and decrease costs. This immunization program also utilizes pharmacy interns as an integral part of the workflow, which decreases pharmacist time and expense for screening and documentation. The pharmacy intern that completed the pilot study provided verbal feedback that the additional workload was feasible for pharmacy students and interns to fit into their existing workflow. There are additional considerations that need to be taken into account prior to expanding this pilot program. First, the flowchart that was created to help the intern screen for vaccine eligibility will need to be updated annually. This task will be completed by the pharmacy intern prior to beginning to screen patients each year, and it will be approved by the pharmacist. November/December 2019

The Journal 33


Second, each intern participating in this project needs to obtain access to the WIR. The site administrator will enroll each intern who will then create a login and password and sign the WIR User Agreement. Additionally, training on using the WIR will need to be provided to new interns. Finally, there may be patients that are unable to provide consent for their vaccine due to the state of their physical or mental health. A procedure for obtaining consent from the patient’s agent or guardian will need to be created in coordination with each nursing facility. Although these additional steps will require extra time and resources, the positive results of this pilot suggest that it would be a worth-while investment. This immunization program is not without limitations. For instance, vaccine screening is done solely using the WIR. If a vaccine was administered to a patient outside of Wisconsin, or if a patient’s past vaccinations were not recorded in the WIR, this program could lead to unnecessary vaccinations. However, some of this risk can be mitigated during the consent process by asking the patient if they have received the vaccine in the past or if they have ever received vaccines outside of Wisconsin. Similarly, if a patient does not have a profile in the WIR, the current workflow of this immunization program does not apply, and a patient may not receive indicated immunizations. The pilot study was also limited by a small sample size. However, given the clear need for immunizations demonstrated by the pilot study, implementation of the full immunization program is warranted.

Conclusion

Vaccination rates among residents in LTC facilities remain below the Healthy People 2020 goals.2 Interdisciplinary strategies and communication between providers, pharmacy, and nursing home staff can facilitate immunization coverage and protect this vulnerable population against vaccine-preventable diseases. Our pilot study of one LTC facility showed that 100% of patients with a profile in the WIR were indicated for at least one vaccination. These results can be used to encourage the development of screening processes and programs to improve immunization rates 34  The Journal

November/December 2019

in nursing home facilities throughout the state. Alexandra M Vecchia, Lindsey C Skubitz, Courtney J McGee, Matthew K Tourdot, Herolind Jusufi, and Kristin K Niemi are 4th Year Doctor of Pharmacy Candidates at the University of Wisconsin-Madison School of Pharmacy in Madison, WI.

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This article has been peer-reviewed. The contribution in reviewing is greatly appreciated!

Acknowledgments: The authors would like to thank Darcy Coddington, PharmD, Pharmacy Manager for her contribution. The authors would also like to thank Betty Chewning, Ph.D., Joanne Peters, Ph.D., and Yolanda Tolson, RPh, from the University of Wisconsin School of Pharmacy.

Disclosures: The authors declare no real or potential conflicts or financial interest in any product or service mentioned in the manuscript, including grants, equipment, medications, employment, gifts, and honoraria.

References

1. Burke M, Rowe T. Vaccinations in older adults. Clin Geriatr Med. 2018;34(1):131-143. 2. Healthy People 2020. Immunization and infectious diseases. https://www.healthypeople. gov/2020/topics-objectives/topic/immunizationand-infectious-diseases/objectives. Updated July 12, 2019. Accessed July 22, 2019. 3. Wisconsin Department of Health Services. Respiratory virus surveillance report. https:// www.dhs.wisconsin.gov/publications/p02346.pdf. Updated May 18, 2019. Accessed July 22, 2019. 4. Wisconsin Department of Health Services. Vaccination coverage among Wisconsin adults by vaccine, county of residence and year. https:// www.dhs.wisconsin.gov/publications/p02005a.pdf. Updated March 2019. Accessed July 22, 2019.

2020 Conference Calendar Midwest Pharmacy Expo Friday-Sunday, February 7-9 Hilton Des Moines Downtown, Des Moines, Iowa

Immunization Delivery for Pharmacists Date TBD Milwaukee Marriott West, Mau

PSW Legislative Day Wednesday, February 12 Monona Terrace Convention Center, Madison

Leadership Pharmacy Conference Date TBD Eagle Ridge Inn & Resort, Galena, IL

Immunization Summit Wednesday, February 26 Glacier Canyon Lodge, Wisconsin Dells

Immunization Delivery for Pharmacists Thursday, August 27 Kalahari Resort & Conventions Center, Wisconsin Dells

PSW Educational Conference Thursday-Friday, April 2-3 Monona Terrace Convention Center, Madison PSW Senior Care Conference Thursday-Friday, May 14-15 Milwaukee Marriott West, Waukesha

PSW Annual Meeting Thursday-Saturday, August 27-29 Kalahari Resort & Conventions Center, Wisconsin Dells PSW Technician Educational Forum Friday-Saturday, October 23-24 Holiday Inn, Manitowoc

www.pswi.org


Target audience: Immunization providers and advocates, including immunization coalition representatives, clinic-based health care providers and teams, pharmacists, health plan leaders, and others with a passion for expanding access to immunizations

Registration Immunization Summit • February 26, 2020 DIETARY NEEDS ☐ I have special dietary needs. (e.g. gluten free, vegetarian, etc.)

Name (as you would like to see it on your name tag)

My dietary needs are:

Worksite

________________________________________________

Address

________________________________________________

City                 State    Zip

LOCATION

Glacier Canyon Lodge, Wisconsin Dells

Is this a ☐home or ☐worksite address? Work Phone             Fax E-mail Address

REGISTRATION FEES CONFERENCE FEES

Price

☐ Member ☐ Non-member

$25 $______

PAYMENT

$25

Amount

$______

Total Enclosed $______________

Send this form with check (payable to: Pharmacy Society of Wisconsin) or credit card order to: PSW, 701 Heartland Trail, Madison, WI 53717 Charge:  ☐ VISA

☐ Master Card   ☐ Discover

☐ American Express

Card #___________________________ Exp Date________ 3-4 digit security code_______ Name on Card_______________________________________________________________ ☐ YES, preferred address above is the billing address

Billing Address________________________________________________________________ ____________________________________________________________________________ Signature____________________________________________________________________

FOUR WAYS TO REGISTER

Mail: Pharmacy Society of Wisconsin 701 Heartland Trail Madison, WI 53717 Call: 608.827.9200 Fax: 608.827.9292 Web: www.pswi.org


Original Work

Implementation of a System-wide, Telephonic, Pharmacist-led Population Health Program: Metformin Dose Optimization by Meaghan A. McMurray, PharmD, BCPS, Bradley J. Schermetzler, PharmD, BCACP, Marisa K. Goninen, PharmD, BCACP

H

ealthcare spending in the United States is known to be significantly higher than other developed countries, without advancements in measures such as life expectancy or infant mortality rate.1 “In 2016, the United States spent 17.8% of its GDP on healthcare (range of the other countries, 9.6%-12.4%; mean of all 11 countries, 11.5%) and had almost double the health spending per capita (mean, $9,403) compared with the other countries (range, $3,377-$6,808; mean of all 11 countries, $5,419).”1 Life expectancy was the lowest in the United States, at 78.8 years, and infant mortality was the highest, at 5.8 deaths per 1,000 live births.1 It has become clear that our population is not achieving maximum value in healthcare compared to other high-income nations. The “Triple Aim” was developed to address the discrepancy between costs and outcomes. The three components of the Triple Aim include: patient care experience, health of a population, and per capita cost.2 A crucial concept of the Triple Aim is the interdependency of these three components; succeeding in cost savings but sacrificing patient care experience or health of a population does not amount to overall success.2 Striking a balance between the interdependent components can enable healthcare systems to attain value. Burnout of healthcare providers and their team members has led to the proposed “Quadruple Aim.”3 “Burnout is associated with lower patient satisfaction, reduced health outcomes, and it may increase costs. Burnout thus imperils the Triple Aim.”3 In order to make strides in patient care experience, health of a population, and per capita cost, it is essential to consider how burnout can be lessened for the patient’s care team. As healthcare reimbursement

36  The Journal

November/December 2019

Abstract Objective: To implement a metformin dose optimization program for risk contract patients with poorly controlled Type 2 diabetes taking suboptimal doses of metformin, which used an evidence-based protocol, embraced coordinated care, and provided an additional approach to enhance clinical outcomes and service quality. Methods: Patients in a risk contract with Type 2 diabetes (HbA1c 7-10%) who were prescribed metformin (≤ 1500 mg/day) were included. Patients were excluded if they were prescribed additional diabetes medication(s) or had safety concerns, such as renal impairment. These criteria were used to build a report that proactively identified patients experiencing clinical inertia. With an evidence-based collaborative practice agreement and protocol in place, centralized pharmacists led targeted interventions for patients across Wisconsin. They performed telephonic outreach to enroll patients, with follow-up every 2-4 weeks during the 12-week program. In addition to titrating the metformin dose, pharmacists also provided patient monitoring, education, and adherence support. Provider engagement was determined based on the percentage of providers that co-signed the referral order request that was sent through the EHR by the pharmacist. Patient engagement was determined based on the percentage of patients that agreed to participate in the program during the initial pharmacist contact. Results: Patients who completed the Metformin Dose Optimization Program had an average HbA1c improvement of -0.6% (from 7.7% to 7.1%), with sustained control after program completion. Provider engagement was measured 93% and patient engagement was 63%. Conclusions: Telephonic health initiatives in a centralized location can have a broad reach, all while enhancing coordinated, team-based care. Pharmacist disease management programs that utilize a collaborative practice agreement can efficiently improve a wide variety of quality measures as healthcare reimbursement transitions to value-based payment models.

models transition from fee-for-service to value-based payments, pharmacists have an opportunity to engage in disease management activities that improve the

health of the population and reduce the burden on providers. Advocate Aurora Health enters into risk-based contracts with commercial and www.pswi.org


public payers, assuming responsibility for the quality and cost of care provided. Pharmacist-led disease management programs are tools that can enhance and support the care of risk contract patients with chronic diseases, increasing the value of care. One such chronic disease with many attributed quality measures is diabetes mellitus. For this reason, pharmacists at Advocate Aurora Health have initially worked to improve diabetes control for its risk contract population by focusing on a cornerstone of therapy, metformin. Metformin, along with lifestyle modifications, is the gold standard initial treatment of Type 2 diabetes as recommended by the American Diabetes Association in the Standards of Medical Care in Diabetes-2019.4 It is highly efficacious with 1.5% HbA1c reduction on average.5 It has been proven safe in extensive studies, with lack of hypoglycemia and potential ability to provide cardiovascular benefit.4,5 At an approximate average wholesale price (AWP) as low as $4 per month, metformin is much less expensive than some other treatments for Type 2 diabetes that may have an AWP of hundreds of dollars per month.4 With its efficacy, safety, and low cost, metformin is a valuable treatment for patients with Type 2 diabetes. As of 2014, the lifetime cost to treat diabetes was estimated at $124,600 for a patient diagnosed at age 40; it is likely even more expensive now.6 Delaying expensive brand-name treatments may reduce costs in the long-term. Considering the advantages of metformin and lifetime cost to treat diabetes, maximizing the potential benefit of metformin is imperative to cost savings. In maximizing this inexpensive treatment, it is the hope that the patient’s diabetes can be controlled with just one affordable, effective, and safe medication for as long as possible. Titration to the maximum tolerated dose of metformin allows the patient to obtain maximum potential benefit. The maximum total daily dose is 2,550 mg per day of immediate-release metformin, and up to 2,000 mg per day of extended-release metformin.7 As long as a patient is not experiencing intolerable adverse effects, they will receive the most benefit from the www.pswi.org

BOX 1. Inclusion and Exclusion Criteria Inclusion Criteria • Risk contract patient based on current insurance • Type 2 diabetes mellitus • Age 18-75 years old • HbA1c 7-10% • Current metformin dose ≤ 1500 mg/day

Exclusion Criteria • Currently prescribed additional diabetes medication(s) • Pregnancy • Renal impairment (eGFR < 45 mL/min) • Clinically significant liver disease (ALT, AST > 2.5x ULN, and/or evidence of cirrhosis) • Unstable or acute heart failure • History of acute or chronic metabolic acidosis (including diabetic ketoacidosis)

eGFR=estimated glomerular filtration rate; ALT=alanine aminotransferase; AST=aspartate aminotransferase; ULN=upper limit of normal

maximum tolerated dose.8,9 The longer a patient can delay additional diabetes medications, the more potential there is for cost savings and adverse event avoidance. Metformin is often initiated at a low dose and intended to be incrementally titrated upwards, as frequently as every two weeks (ranging from five days to one month), to reduce potential adverse effects.7,10,11 In studying the time to treatment intensification, Khunti et al. found that it could take up to 3 years before medication adjustment after an increased HbA1c result.12 “The term ‘clinical inertia’ in most instances has been used in relation to failure to advance therapy when appropriate to do so.”13 If medication adjustments are made at provider office visits every 3-6 months, there is likely a prolonged titration to the maximum tolerated dose. Providers may delegate metformin titration and monitoring of safety and efficacy to another healthcare team member such as a pharmacist to decrease workload, enhance between-visit care, and ultimately achieve improved health outcomes for patients. Pharmacists at Advocate Aurora Health identified an opportunity to improve the benefit patients receive from metformin therapy. Extensive internal data retrieval and analysis showed that some patients were in a state of clinical inertia, where they could be receiving a higher dose of metformin but instead remained on the same, smaller dose of the drug as their HbA1c slowly rose over time. By collaborating with physician leaders, population health pharmacists implemented a program that would optimize metformin dose based on

evidence, embrace coordinated care, and provide an additional approach to enhance clinical outcomes and service quality for risk contract patients.

Methods

The Metformin Dose Optimization Program took a population health approach to risk contract adult patients with poorly controlled Type 2 diabetes taking suboptimal doses of metformin. Involvement from primary care physician leaders was sought to obtain support and install a collaborative practice agreement to enable pharmacist-led targeted interventions using an evidence-based protocol. Medical directors provided a review of the proposed protocol prior to signing the collaborative practice agreement. A strategic communication plan was developed that involved both organization-level primary care physician leaders as well as local physician leaders in each region. The goal of this communication plan was to foster collaboration and cultivate program acceptance by delivering a clear message to all involved parties. The program was conducted telephonically by a centralized group of pharmacists with patients spread throughout the Advocate Aurora Health Wisconsin footprint. The data collection period was from October 2017 to December 2018, during which the program was being expanded to all Wisconsin regions. Risk contract adult patients with Type 2 diabetes mellitus were included if they had a HbA1c of 7-10%, taking metformin ≤ 1,500 mg per day. Patients were excluded November/December 2019

The Journal 37


FIGURE 1. Program Workflow Patient identified for suboptimal metformin dose

Patient enrolled in program

Initial encounter and baseline patient assessment

No

Yes

Problems?

-

Increase daily dose by up to 500 mg (max total daily dose 2000 mg)

Options: Reduce dose Continue current dose Change formulation Notify MD if appropriate

2 week follow-up

Continue every 2 weeks until: - Goal total daily dose 2000 mg [or] - 12 weeks since start of program [or] - Patient referred back to PCP

Discharge from program 38  The Journal

November/December 2019

if they were prescribed additional diabetes medication(s) or had safety concerns, such as renal impairment. Box 1 contains the full list of inclusion and exclusion criteria. These criteria as well as patient qualifiers were leveraged to build a report that proactively identified patients experiencing clinical inertia. Pharmacists sent referral orders to providers within the electronic health record (EHR), giving providers autonomy to approve or deny pharmacist management for each patient. Pharmacists performed telephonic outreach to enroll patients, with follow-up every 2-4 weeks during the 12-week program. Under the collaborative practice agreement, they were able to adjust the metformin dose and change the formulation if needed. In addition, pharmacists also provided patient monitoring, education, and adherence support for metformin (Figure 1). All pharmacist encounters were visibly documented in the EHR, and a summary was sent to the patient’s provider at program completion. Documentation tools with discrete elements were built in the EHR to enable efficient, consistent documentation and effortless data retrieval. The primary clinical endpoint was

TABLE 1. Baseline Characteristics Characteristic

n=241

Male

102 (42%)

Female

139 (58%)

Age ≤ 19

0 (0%)

Age 20-29

1 (0%)

Age 30-39

7 (3%)

Age 40-49

17 (7%)

Age 50-59

47 (19%)

Age 60-69

100 (41%)

Age 70-75

69 (29%)

HbA1c 7.0-7.9%

177 (73%)

HbA1c 8.0-8.9%

52 (22%)

HbA1c 9.0-9.9%

10 (4%)

HbA1c 10.0%

2 (1%) www.pswi.org


mean change in HbA1c. Secondary findings included the change in total daily metformin dose and program engagement. Program engagement was measured for both providers and patients. Provider engagement was determined based on the percentage of providers that co-signed the referral order request that was sent through the EHR by the pharmacist. Patient engagement was determined based on the percentage of patients that agreed to participate in the program during the initial pharmacist contact.

FIGURE 2. Program Enrollment

Enrolled in program (n=210)

Results

Most patients enrolled in the program were female between the ages of 60-69 years, with baseline HbA1c of 7.0-7.9%. Table 1 summarizes the baseline demographics of patients who were candidates for program enrollment (n=241). Of 241 potential candidates, 210 were enrolled in the program (Figure 2). Thirtyone patients were not enrolled, for reasons including but not limited to: patient did not meet inclusion criteria or met exclusion criteria. Of the 210 patients enrolled in the program, 133 patients successfully completed the program and 77 patients either refused program participation or were lost to follow-up. Primary Findings The overall mean change in in HbA1c was -0.6% (from 7.7% to 7.1%; n=98) in patients who successfully completed the 12-week program and had a post-program HbA1c value available (Figure 3). Some patients who successfully completed the program have since had a second HbA1c completed. In this group, initial change in HbA1c was -0.4% (from 7.7% to 7.3%; n=38), with sustained and continued improvement to 7.2% on average at the second HbA1c measurement. HbA1c results were also evaluated for patients that were lost to follow-up and did not successfully complete the program. Patients were considered lost to follow-up after three failed outreach attempts and were lost 6.47 weeks on average after program enrollment. Of this group of patients with a post-program HbA1c value available, a mean change in HbA1c of -0.3% (from 7.7% to 7.4%; n=57) was observed. www.pswi.org

Potential program candidates (n=241)

Post-program HbA1c value(s) available (n=57)

Not enrolled in program (n=31)

Patient refusal or lost to follow-up (n=77)

Successfully completed program (n=133)

Post-program HbA1c value(s) not available (n=20)

Post-program HbA1c value(s) available (n=98)

One post-program HbA1c value available (n=60)

Post-program HbA1c value(s) not available (n=35)

Two post-program HbA1c values available (n=38)

FIGURE 3. HbA1c Progression

November/December 2019

The Journal 39


FIGURE 4. Average Metformin Total Daily Dose

Secondary Findings Upon enrollment, the average total daily metformin dose was 912 mg, per prescription orders entered in the EHR, but it was 800 mg on average as reported by patients (Figure 4). At time of discharge from the program, whether the patient successfully completed it or was lost to follow-up, the average total daily dose of metformin was 1,576 mg per prescription orders entered in the EHR and patient assessment at the final pharmacist contact. Of the 133 patients who successfully completed the program, 73.7% underwent a dose increase (n=98). Provider engagement, those who agreed to metformin optimization by a pharmacist, was measured at 93%. Patient engagement, those who agreed to participate in the program, was 63%. The remaining patients either refused enrollment or were not able to be reached after three pharmacist outreach attempts.

Discussion

The improvement in HbA1c measurements demonstrated a positive pharmacist impact on diabetes control for risk contract patients at Advocate Aurora Health. Personalized pharmacist support allowed these patients to receive more benefit from metformin and achieve improved diabetes control. Therefore, 40  The Journal

November/December 2019

the pharmacist-led Metformin Dose Optimization Program was successful and fulfilled its purpose. The transition from fee-for-service to value-based payment models necessitates a population health approach to care, one in which pharmacists can take an active role. Collaborating with healthcare providers in population health efforts can enable top-of-license pharmacist practice, which can improve healthcare quality while reducing cost and improving value. In this specific case, pharmacists were able to assist providers by enhancing diabetes care for their patients, and diabetes control was improved with the hopes of delaying additional, expensive diabetes treatment and diabetic complications. Optimizing patients’ use of metformin can help defer additional health care costs associated with diabetes. According to the American Diabetes Association, inpatient hospitalizations (30%) and medications to treat diabetic complications (30%) make up a significant portion of the costs associated with diabetes.14 Reducing the costs of care in the diabetic population has allowed Advocate Aurora Health to expand its pharmacist-led disease management programs. Limitations There were several notable limitations

of this program. First, the program is only available to patients whose health insurance plan has a risk-based contract with Advocate Aurora Health. These patients represent only a subset of all patients cared for by Advocate Aurora Health, and therefore many patients are not able to benefit from the program. It would be ideal to offer the program to all patients. A second limitation was the telephonic method of outreach. The pharmacists were able to reach patients across a broad geographic footprint, but some patients were not able to be reached. Anecdotally, many of the patients that were not enrolled were unable to be reached, versus patient denial to participate. This limitation reduced the number of patients that were able to receive personalized pharmacist support for their diabetes control. Pharmacist resources were a third limitation to this program. There were many more candidates eligible for pharmacist outreach than there was pharmacist time available to complete the outreach. Positive results have since led to expansion of pharmacist full-time equivalents and therefore the number of patients enrolled. Lastly, this program has the potential to be more impactful with additional diabetes medications included in the protocol. Pharmacists were limited to optimization of metformin only and could not prescribe additional medications according to evidence-based guidelines, even if patients continued to experience elevated blood glucose levels after reaching the maximum tolerated dose of metformin. There is opportunity for additional impact in the future if pharmacists can continue intensification of diabetes treatment when clinically appropriate.

Conclusion

Utilization of a collaborative practice agreement and protocol to perform centralized, telephonic pharmacy services to a broad patient population enhanced the quality and coordination of care. The positive results from the Metformin Dose Optimization Program indicate a promising future to pharmacist advancement in population health initiatives. In addition to program expansion across Advocate Aurora Health’s Illinois footprint, focus may be www.pswi.org


placed on medication adherence to excel in Medicare star ratings and development of new chronic disease management programs. Endless possibilities lie ahead for increased collaboration in health care systems leading to an enhanced patient experience, improved health outcomes, and better cost containment. Meaghan McMurray is the Manager of Population Health Pharmacy Programs at Advocate Aurora Health in Milwaukee, WI. Bradley Schermetzler is the Pharmacy Clinical Coordinator of Informatics & Population Health Pharmacy Programs at Advocate Aurora Health in Milwaukee, WI . Marisa Goninen is the Pharmacy Clinical Coordinator of Population Health Pharmacy Programs at Advocate Aurora Health in Milwaukee, WI.

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This article has been peer-reviewed. The contribution in reviewing is greatly appreciated!

Disclosures: The authors declare no real or potential conflicts or financial interest in any product or

service mentioned in the manuscript, including grants, equipment, medications, employment, gifts, and honoraria. Bradley J. Schermetzler, PharmD, BCACP: The author declares no real or potential conflicts or financial interest in any product or service mentioned in the manuscript, including grants, equipment, medications, employments, gifts, and honoraria. The author declares that he had full access to the original data and takes responsibility for the integrity of the data and the accuracy of the data analysis.

References

1. Papanicolas I, Woskie LR, Jha AK. Health care spending in the United States and other high-income countries. JAMA. 2018;319(10):1024-1039. 2. Berwick DM, Nolan TW, Whittington J. The triple aim: care, health, and cost. Health Aff. 2008;27(3):759-769. 3. Bodenheimer T, Sinsky C. From triple to quadruple aim: care of the patient requires care of the provider. Ann Fam Med. 2014;12(6):573-576. 4. American Diabetes Association. Standards of Medical Care in Diabetes-2019. Diabetes Care. 2019;42(Suppl 1);S1-S193. 5. DeFronzo RA, Goodman AM. Efficacy of metformin in patients with noninsulin-dependent diabetes mellitus. N Engl J Med. 2002;333(9):541-549.

6. Zhuo X, Zhang P, Barker L, Albright A, Thompson TJ, Gregg E. The lifetime cost of diabetes and its implications for diabetes prevention. Diabetes Care. 2014;37(9):2557-2564. 7. Glucophage, Glucophage XR [package insert]. Princeton, NJ: Bristol-Myers Squibb Company; 2018. 8. Garber AJ, Duncan TG, Goodman AM, Mills DJ, Rohlf JL. Efficacy of metformin in type II diabetes: results of a double-blind, placebo-controlled, dose-response trial. Am J Med. 1997;103(6):491-497. 9. Hirst JA, Farmer AJ, Ali R, Roberts NW, Stevens RJ. Quantifying the effect of metformin treatment and dose on glycemic control. Diabetes Care. 2012;35(2):446-454. 10. Glumetza [package insert]. Bridgewater, NJ: Valeant Pharmaceuticals North America LLC. 1995. 11. Riomet [package insert]. Jacksonville, FL: Sun Pharmaceutical Industries Limited. 2017. 12. Khunti K, Wolden ML, Thorsted BL, Andersen M, Davies MJ. Clinical inertia in people with type 2 diabetes: a retrospective cohort study of more than 80,000 people. Diabetes Care. 2013;36(11):3411-3417. 13. Khunti K, Seidu S. Therapeutic inertia and the legacy of dysglycemia on the microvascular and macrovascular complications of diabetes. Diabetes Care. 2019;42(3):349-351. 14. American Diabetes Association. Economic costs of diabetes in the U.S. in 2017. Diabetes Care. 2018;41(5):917-928.

PSW Legislative Day Wednesday, February 12, 2020 Monona Terrace Convention Center Madison

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Spotlight

WPQC Spotlight: Karen Roby, Mount Horeb Pharmacy by Angeline Ngo, 2020 PharmD Candidate

K

aren, a graduate of the University of WisconsinMadison School of Pharmacy, has been the owner of Mount Horeb Pharmacy since 2004 alongside her husband, Dave. The couple met early in their careers while working together at the same long-term care pharmacy. They always knew that they wanted to own a pharmacy together, so when the opportunity presented itself in Mount Horeb, the two took the chance. With Karen handling the medical and pharmacy affairs and Dave leading the business and technical aspects, the husband and wife duo have been continuing to provide patients with quality care ever since. Being an independent pharmacy competing with other larger pharmacies comes with its struggles, but the Roby’s stand out by providing their patients with a variety of services that go above and beyond including medication reviews, medication box filling, delivery, assisted living services, and a MedSync program. Mount Horeb Pharmacy is proud of the genuine relationships that are fostered between patients and pharmacists there. When she isn’t managing and keeping her pharmacy up and running, Karen spends her free time providing comprehensive medication reviews (CMRs) at a variety of different events throughout the community through the Wisconsin Pharmacy Quality Collaborative (WPQC) CMR program as a partnership with the United Way of Dane County. Some are with the same patients who come to her pharmacy, but there are also many new faces that Karen enjoys being able to meet as well. What started off as an extra source of income has become something that Karen has found great professional satisfaction in.

Community-based CMRs

So what is Karen’s secret to being

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Future of Pharmacy Practice & More PSW: What got you interested in becoming a WPQC pharmacist? Karen: All the resources PSW provides for their WPQC pharmacists! The toolkits, the webinars, the training; all those resources are so valuable especially to a busy pharmacist that doesn’t have the time to research and develop tools on their own. Just getting involved with CMRs and being able to participate in them with United Way of Dane County is a huge incentive to join…you get very involved with people, talking and engaging so sometimes it’s tiring, but it’s also very rewarding! I do get quite a few hugs after just an hour of knowing somebody! It’s those types of relationships that make it fun. PSW: 25 years from now, what do you hope the future of pharmacy practice will look like? Karen: I think maybe just continuing in the direction that it’s going with more emphasis on clinical type services. I’m also hoping that patients will utilize the services that are available to them. I don’t think they always know they’re out there, feel comfortable, or know the benefits of utilizing them. The more we do, the more people will talk…and the one thing I hope is that [these services] will be normal day-to-day patient care provided by the pharmacy profession. PSW: I hope so too! I guess we’re coming towards the end of our interview – is there anything else you’d like the world of PSW to know about? Karen: I just want to thank PSW for initiating programs like the CMR events and helping pharmacists to do their job effectively and responsibly by the services they provide and all of their hard work!...so thanks to PSW for all they do! PSW: You have been in Wisconsin for a while and you’ve not only seen the progression of pharmacy practice throughout the year, but also the progression of the infamous Babcock ice cream flavors. So what is your favorite flavor? Karen: The old school mint chocolate chip.

comfortable providing CMRs at community and senior centers? Her background in community pharmacy not only fostered her clinical knowledge needed

to excel as a WPQC-certified pharmacist, but it also gave her the necessary people skills as well. “With some people I can use humor…some people I can’t…some www.pswi.org


people I can talk more in a professional manner using medical terminology and some people I can’t. You have to tailor each CMR to the patients you’re working with.” She remembers one patient she met at a CMR event who was having severe stomach pain. It caused the patient to wake up every night, and she could barely sleep at all. “I simply asked her doctor for a possible prescription for omeprazole. [The patient] after starting the new prescription came in crying because she felt so much better and gave me a hug!” Another patient she met had significant medication nonadherence. After further discussion, she discovered that he had lost his driver’s license and was unable to pick up his prescriptions without having to burden someone to drive him. She helped him enroll in their Med Sync program and have his medications delivered directly to his home on a regular basis. Angeline Ngo is a Fourth Year Doctor of Pharmacy Candidate at the University of Wisconsin-Madison School of Pharmacy in Madison, WI. Above: Karen Roby at Mount Horeb Pharmacy. Below: Karen Roby receiving her WPQC Award at the 2019 PSW Annual Meeting in Green Bay on Friday, September 13, 2019

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Spotlight

Pharmacy Leadership Spotlight: Jill Michaud by Kate McBride, 2020 PharmD Candidate, Griffin Budde, 2020 PharmD Candidate

J

ill Michaud (PharmD, BCPS) is currently the System Director of Pharmacy at Aspirus Wausau Hospital. She has served the Wisconsin community in many leadership roles, and has made significant contributions to the improvement of patient care through pharmacy services. Even with her many accomplishments, Dr. Michaud holds gratitude above it all. When she was growing up in Pittsville, WI, one of her sisters suggested pharmacy to her as a career. The idea stuck, and she pursued it. Over the years Dr. Michaud fell wholly into the world of pharmacy, and excelled. She is incredibly grateful to her profession for giving her invaluable opportunities and a world she says she never could have imagined.

Advancing Pharmacy Practice Dr. Michaud earned her Doctor of Pharmacy degree from the University of Minnesota-Twin Cities. She is a graduate of the ASHP Clinical Residency at the Denver Veterans Affairs (VA), and earned a Master’s degree in Health Care Administration and Management from

Valparaiso University. Dr. Michaud started her career as a clinical pharmacist, and states she never expected to be in a management role. However, she soon became a clinical coordinator and was able to see immense opportunity for change. She progressed into pharmacy management roles with the aim of enhancing pharmacist care within her patient population. Today, as System Director of Pharmacy at Aspirus Wausau Hospital, Dr. Michaud oversees a number of pharmacies throughout the Aspirus system. She has made many innovations for Aspirus, including a 24-hour glycemic management service, operational implementation of Epic provider order entry, development of pharmacy budget strategies, and plans for the provision of pharmacy services within the health system. She has advanced the practice of pharmacists and created a high standard of care within the rural setting. She also provides leadership in patient safety and the medication use process.

Supporting the Community

Dr. Michaud served on the Pharmacy Society of Wisconsin Board of Directors from 2011 to 2015. She says this opportunity gave her valuable insight into

aspects of pharmacy practice that she does not typically see, such as managed care and specialty pharmacy. Among her numerous contributions to PSW, Dr. Michaud states that being elected to serve for and by her pharmacy peers was one of the most rewarding aspects of her time on the board. Dr. Michaud continues to make a powerful impact on the pharmacy community. When asked about her top priorities within her health system, she confidently described her goals. She seeks to continue to advance pharmacy practice by expanding her staff and by advocating for an ambulatory setting. “Unless providers are working side by side pharmacists, providers aren’t fully aware of what pharmacists are capable of doing or contributing to patient care,” says Dr. Michaud. “Four years ago, I wanted to add a pharmacist in the ED [i.e. emergency department] and received initial pushback. Now that I have shown the value of a pharmacist in the ED, we currently staff a pharmacist there ten hours a day, seven days a week.” She similarly envisions transitions of care pharmacists to follow patients through the many stages of their care. She has a strong commitment to management of the opioid crisis, and seeks to address healthcare disparities in her community. Above all, she is constantly seeking to improve medication and patient safety.

To the Next Generation of Pharmacists Dr. Michaud is an avid proponent of student learning, and has contributed immeasurably to the Aspirus clinical residency program. Her advice to future pharmacy leaders can be seen in the examples she has set. “You have to want to lead for the right reasons. Put your ego aside, and look at everything through other people’s lenses,” says Dr. Michaud. “Don’t ask someone to do something that you haven’t done, especially if you’re not willing to set that example. We’re here to make 44  The Journal

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Above: Jill Michaud (center) and her pharmacy staff at Aspirus Wausau Hospital.

good things happen for other people.� This is truly a mentality that Dr. Michaud emulates through her selfless service to the pharmacy community, and through her dedication to patient care. Kate McBride and Griffin Budde are 4th Year Doctor of Pharmacy Candidates at the University of Wisconsin-Madison School of Pharmacy in Madison, WI.

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PSW News

Pharmacists Perception of the Utility of Nonvaccine Injection in Their Practice Revisited Two Years Later by Eric C. Buxton, PhD, Sarah Sorum, PharmD

T

he 2015 Wisconsin Act 290 was enacted March 30, 20161 enabling pharmacists to administer non-vaccine injections to support patient access and adherence, and to enable pharmacists to serve in a broadened role on the health care team. Subsequent to the law’s enactment, the Wisconsin Pharmacy Examining Board (PEB) promulgated rules outlining requirements for this administration. A PEB-issued emergency rule served to support implementation of these pharmacist-provided services until the PEB rules were finalized on September 1, 2017. Wisconsin law requires that, in order to provide a non-vaccine injection, pharmacists need to complete a course of study that includes: 1) Safe injection practices to prevent infections, 2) Anatomy, 3) Proper injection techniques, 4) Five rights of administration (right patient, right drug, right dose, right route, right time), 5) Patient reassessment after administration including signs and symptoms of adverse drug reactions, and 6) Best practices in documentation of the medication administration. This course of study may include pharmacist immunization training as long as the immunization training is accredited by the Accreditation Council for Pharmacy Education (ACPE) and includes these elements required by law. In an effort to train interested pharmacists, the Pharmacy Society of Wisconsin (PSW) offered a training session during the PSW Educational Conference in April, 2017. To further expand the reach of this program, the session was recorded and the Division of Pharmacy Professional Development (DPPD) at the University of Wisconsin-Madison School of Pharmacy offered this program online. DPPD collaborated with PSW to create additional 46  The Journal

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FIGURE 1. Pharmacist Perceived Usefulness of Non-vaccine Injections in Their Practice (n=53)

FIGURE 2. Approximate Number of Patients Administered Non-vaccine Injections Since Receiving Training (n=53)

online programming that fulfilled the requirements, but was focused on specific therapies or settings. As of April 15, 2019, 216 pharmacists have completed various

online programs related to non-vaccine injection administration. As with the live program, those who previously completed vaccine administration training and these www.pswi.org


online programs were now permitted to administer non-vaccine injections. These CE modules did not provide any vaccine administration training, and only the “inpatient setting” module required participants to demonstrate proper injection technique. In the fall of 2017, DPPD and PSW surveyed the initial cohort of pharmacists completing this training to learn their perceived utility of the law in the first six months after the course was offered.2 Forty of the initial 102 pharmacists completing the training completed the survey. The results were positive and showed that, while some pharmacists who completed the training had yet to apply this new service, those who had implemented the new service offering were beginning to realize the benefits. Thirty-six out of 40 respondents felt that the ability to administer non-vaccine injections was at least “slightly useful”. Since most (75%) had administered less than 10 injections, it was not surprising that a slight majority felt that their practice focus had not changed. The report concluded with a desire to query pharmacists completing this training a year or more in the future to get a better picture of potential practice changes.

Impact

Now that more than two years have passed since the law was changed, it is possible to evaluate the effects of the law further. In April 2019, a survey was created using Qualtrics online survey software and sent to the 216 pharmacists who completed the online programming since it became available. The survey was similar to the 2017 evaluation to also allow comparison with the present results to the initial survey. Fifty-five pharmacists responded (24.5%). Of those who responded, 84% indicated that they practiced in an ambulatory/community setting, one indicated “other” while the remaining 15% practiced in an institutional setting. When asked whether their employer recommended they take the training, or it was self-interest, 60% indicated that their employer recommended the training, and 40% registered on their own. Twenty-nine percent of the respondents have been able to administer non-vaccine injections for 1-6 months, 30% 6-12 months, 30% 1-2 www.pswi.org

TABLE 1. Description and Examples of How the Ability to Administer Non-vaccine Injections Has Changed Practice Focus (n=16 comments) Theme Expanded practice

Increased patient access

New business opportunities

Count

Example statements

8

“I have a new service to offer my patients and providers.”

10

“I think this helps patients so they do not necessarily have to make an appointment for this injection, and helps with compliance. I think it also helps with these smaller communities because the nearest doctor office might be farther than our community pharmacies.”

7

years, and 11% more than two years. Next, the respondents were queried using a 7-point Likert scale about the utility of non-vaccine injection administration by pharmacists in their practice (Figure 1). Of the 53 who completed the question, 74% percent (39/53) responded that it was “extremely useful” or “moderately useful”. When asked how many patients they had administered non-vaccine injections to, 26% said “none,” 42% indicated 1-10, 19% said “11-50” and 13% indicated greater than 50 patients (Figure 2). For those who had been administering for at least a year (n=22), 14% said “none,” 36% indicated 1-10, 23% said “11-50” and 27% indicated greater than 50 patients. Pharmacists were asked if the ability to perform non-vaccine injections had changed their practice focus. Forty percent indicated “yes” and 60% indicated “no”. Those that answered “yes” were asked how their practice had been impacted. A thematic analysis of the comments revealed several categories related to ways the respondents’ practice had changed: 1) opportunities for expanded practice, 2) increased patient access to medications, and 3) new business and revenue opportunities. Many comments fit into more than one theme and a summary of the 16 comments can be seen in Table 1. One example comment that summed up all three categories was: “It had an impact on the prescriber relationship as it allowed us to help in the patient care process and save the prescribers some time for administration. It

“We are partnering with Counseling (Psych and Detox) offices for maintaining compliance with medications by making access to the medication injections easy with a simple walk in to the pharmacy.”

also provided more streams of business for us. It was definitely a game changer.” The final questions explored reimbursement for non-vaccine injection administration. When asked about reimbursement, only 39% received any level of reimbursement for the administration service (Figure 3). Pharmacists who were not receiving medication administration reimbursement were then asked to describe why they were not receiving reimbursement. Responses included reimbursement not available by payers for pharmacist administration (n=10), not yet having administered a non-vaccine injection or not having tried to be reimbursed (n=5), and not knowing how to submit for payment (n=7). An example response was: “The [organization] I work for was in the process of setting up for administering Vivitrol to opioid-dependent patients. It was a program utilizing a physician available through remote access (Skype) and included many checks and balances to be done on the pharmacy behalf. The legal burden cost for the pharmacy to do it was too high. So the program was not pursued. Part of the process for setting up for the program included certification for administering non-vaccine IM injections.” Those who were receiving reimbursement were asked “by whom and what percentage?”. Responses included various insurance companies (n=5), the products being injected in a clinic or hospital setting (n=1), reimbursement by the manufacturer, and only receiving product reimbursement, not administration reimbursement (n=3). November/December 2019

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FIGURE 3. Pharmacist Reported Reimbursement for Administering Non-vaccine Injections (n=51)

a majority feel that this ability has some utility, a minority have seen a change in practice focus. Reimbursement is likely to be a major reason for this situation and until reimbursement levels improve, the potential gains offered by expanded practice will be impeded. Eric Buxton is the Division Chair of the Division of Pharmacy Professional Development and Clinical Associate Professor at the University of Wisconsin-Madison School of Pharmacy in Madison, WI. Sarah Sorum is the Interim Vice President & CEO of the Pharmacy Society of Wisconsin in Madison, WI.

P

R

This article has been peer-reviewed. The contribution in reviewing is greatly appreciated!

Disclosures: The authors declare no real or potential conflicts or financial interest in any product or service mentioned in the manuscript, including grants, equipment, medications, employment, gifts, and honoraria.

References

An example statement from this question was: “Some manufacturers pay us for submitting records for administration and some plans allow submitting administration fees with the billing."

Discussion

Two years after the non-vaccine injection rules have taken effect, 87% of the respondents felt that the ability to administer non-vaccine injections was at least “slightly useful”. This is similar to the percentage in 2017 (90%).2 Despite 71% having completed this training more than six months ago, a quarter have yet to administer any non-vaccine injections; this is a drop from 40% in 2017. However, 40% of respondents feel that their practice focus has changed. This is roughly the same percentage as those surveyed in 2017 (44%). Those that have seen a change in their practice report potential for expanded practice, increased patient access, and new business opportunities. Reimbursement levels remain low and relatively unchanged 48  The Journal

November/December 2019

from the 2017 survey. The lack of improvement in reimbursement may explain why a minority of pharmacists feel that their practice focus has changed. PSW could play a role in addressing policy and systems barriers that impact pharmacists’ uptake of non-vaccine injections by pharmacists. Discussions with policy-makers are needed to support changes in reimbursement policies. Pharmacists represent an underutilized member of the public healthcare team in supporting efforts to expand medication assisted treatment and treatment of mental health conditions with nonvaccine injections. In addition, efforts to support workflow changes and to support expansion of collaborative team-based care will also support expansion of pharmacistprovided non-vaccine injections to address public health.

1. https://docs.legis.wisconsin. gov/2015/related/acts/290 2. Buxton E, Sorum S, Burns E, Pharmacists’ perception of the utility of non-vaccine injection in their practice. J Pharm Soc Wis. 2018;21(3):57-59.

Conclusion

More than two years have passed since Wisconsin pharmacists have been able to administer non-vaccine injections. While www.pswi.org


FOCUSED ON

PATIENT-CENTERED CARE

from the classroom to the community Concordia University Wisconsin’s School of Pharmacy is committed to the development of pharmacists who are servant leaders, dedicated to providing value-based, patient-centered care that improves the health of our communities in rural and urban areas through excellence in teaching, research, service, and practice.

WE OFFER AACP award-winning PharmD program | PharmD dual-degree programs in public health, product development, and business | PGY1 residency programs | Practice site collaboration

Want to know more? Visit CUW.EDU/PHARMACY or email pharmacy@cuw.edu

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Meeting Recap

2019 PSW Annual Meeting Recap by Ryan Simonet, PharmD, Samantha Lewiston, 2021 PharmD Candidate

T

he 2019 Pharmacy Society of Wisconsin (PSW) Annual Conference took place September 12-14 at the KI Convention Center in Green Bay, Wisconsin. Pharmacists, pharmacy residents, students and pharmacy technicians gathered to present, share, learn and grow with one another at the conference. Featured events this year included new continuing education opportunities, pharmacist programming revolving around clinical practice advancement, health-system leadership, and medication safety, as well as studentfocused workshops, the Annual Awards Banquet celebrating this year’s award recipients, and celebrating the legacy of our own difference-maker, Chris Decker. Conference programming began Friday morning with the Legislative Breakfast, where Joel Kurzman, Regional Director of State Government Affairs for the National Association of Chain Drug Stores, and Allie Jo Shipman, PharmD, Director of State Policy for the National Alliance of State Pharmacy Associations, discussed national trends in state-level pharmacy legislation. Among these trends were efforts to counter the opioid crisis, pharmacist scope of practice, and pharmacy technician role advancement. Mr. Kurzman and Dr. Shipman discussed the different approaches taken by state legislatures nationwide to address the opioid crisis including e-prescribing, initial fill limits, drug disposal, and an opioid “tax.” As for pharmacist scope of practice, the discussion focused on statewide protocols expanding prescriptive authority for hormonal contraceptives and tobacco cessation products. Pharmacy technician roles were also discussed, as several states are expanding this role to include prescription transfers, product verification, immunizations, and medical billing. Danielle Womack, PSW’s Vice President of Public Affairs, concluded the session with a preview of PSW’s 2019-2020 legislative agenda, including the proposed legislation around pharmacist immunization authority

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expansion, technician registration, and pharmacy benefit management regulation. The first general session of the meeting, One Voice. One Vision. One Team. How Innovation Enhances the Patient Experience, was a talk given by Saleem Habash, Senior Director of Patient Access & Experience with Ascension Connect. Mr. Habash described the innovation process and how it continues to advance and support the patient experience within the healthcare system. He challenged pharmacists to identify opportunities in their daily practice to leverage innovation in collaboration with patients to continue to improve the patient experience. Throughout the session, Mr. Habash discussed how the current healthcare system detracts from the patient experience, particularly silos of care. He emphasized how innovation is key to overcoming these silos within our healthcare system. The following general session, Public Health Imperative - Leveraging Pharmacies and Pharmacy Departments to Move the Needle, featured a variety of speakers and public health topics. The session kicked off with Erica Martin, Senior Manager of Practice & Population Health Initiatives at PSW, and a review of academic detailing to enhance clinician behavior change around the statewide naloxone standing order. Ms. Martin was followed by Sarah Pagenkopf, PharmD, BCPS, with an overview of how Fort Healthcare is collaborating with various partners to improve patient outcomes throughout the community. The next topic was expanding immunization access, led by Sarah Sorum, PharmD. Dr. Sorum gave an overview and update on the systems-level change being enacted through the Expanding Access to Immunizations in Wisconsin’s Community Pharmacies project, in partnership with the Medical College of WIsconsin and the Advancing a Healthier Wisconsin Endowment. Continuing the session was Dave Hager, PharmD, BCPS from UW Health and Kate Shaafsma, PharmD, MS from Froedtert and the Medical College of Wisconsin on how medication adherence

continues to be a population health crisis and how pharmacists can get involved, including a pharmacist credentialing program. Next was Taylor Watterson, PharmD, MS with an overview of the Community Management of Medication Complexity (CMMC) Innovation Lab project. The project aims to increase the provision of Comprehensive Medication Reviews (CMRs) to low income patients in Wisconsin with several resources available to pharmacist participants including marketing materials, a CMR Workgroup Coaching Series, and support of a technician driven final product verification workflow. Rounding out the session was PSW’s own Kari Trapskin, PharmD with an update on the WEA Trust Comorbidity Pilot conducted in partnership with nine WPQC pharmacies throughout the state. Results of the pilot will be available in spring 2020. The session concluded with presentation of the WPQC Engagement Awards and Innovation Awards. Over lunch, students and residents presented 25 research posters on topics ranging from trends in continuing education program registration to optimizing anticoagulation therapy. Afternoon sessions offered content for all interests, including a HealthSystem Pharmacy Leadership Forum, Updates in Pediatric Infectious Diseases Pharmacotherapy, New Pharmacist Billing Opportunities and more. A particularly popular session was Risky Business: Contemporary Risk Mitigation Strategies for Chronic Opioid Use. Later programming also included the Diabetes Clinical Toolkit Session: Guideline Update and Medication Safety Roundtables. Friday evening, of course, meant the Friday Night Party! From casino games to trivia, escape room games, and a photobooth, there was fun to be had for all interests and ages. Saturday began bright and early with the Fun Run, Walk and Bike at 6:15am through historic downtown Green Bay. The conference hit the ground running that morning with the Ambulatory Care Networking Session, with over 35 attendees www.pswi.org


including clinical pharmacists, pharmacy residents, and pharmacy students from ambulatory care sites across Wisconsin. The first featured session of the morning, Patient Medication Experiences Shaping their Care Perspective - Moving from “Medication Trauma” to “Medication Trust,” was a powerful presentation given by Dr. Jim Slater, PharmD, Executive Director of Pharmacy Services of CareOregon. Dr. Slater discussed the trauma triangle, which includes anxiety, post-traumatic stress disorder, and depression. The impact of this trauma can be devastating to our patients in the realms of health, behaviors, and life potential. Dr. Slater demonstrated the value a pharmacist can have in reducing medication trauma for patients that have complex interpersonal trauma events throughout their life. Pharmacists need the tools to help patients open up about these experiences, and one of these tools is motivational interviewing. Dr. Slater explained how motivational interviewing can help elicit a patient’s own motivation to change through change talk. Another tool pharmacists can use is the motivational interviewing toolkit Dr. Slater implemented at his own site of practice. During medication reconciliation, patients mark a happy, neutral, or sad face next to each of their medications. This can help the pharmacist identify which medications patients may need further explanation or help with. Finally, Dr. Slater concluded with the powerful message of pharmacists as the partner in the patient’s journey to hope and healing. The day continued with the moving tribute to the late Chris Decker, Remembering a Difference Maker, Leaving a Legacy: A Tribute To Chris Decker, where close friends and colleagues Matt Mabie, RPh and President of PSW, Nick Olsen, Chairman of the Board for PSW, John Sutter, Past President of PSW, and Sue Sutter, Past President of PSW, recalled stories and favorite memories of Chris that encapsulated his passion for pharmacy practice advancement. They described how Chris has inspired so many around him to become difference makers themselves. Chris’ legacy challenges each of us to consider how can we each can become a difference maker through making a difference in the life of a patient or www.pswi.org

colleague every day. Following the next general session, PSW Membership Briefing, Dr. Mike Gillard, PharmD, BCPS, 2019-2020 President of PSW, gave his first presidential remarks. Dr. Gillard focused his presentation around the ever-popular “TED Talk” format, with a slight change to the acronym. For Dr. Gillard, his focused efforts for his presidency will revolve around technician advancement, engagement of pharmacists, residents, technicians, and students across the state, and living out and carrying forward the legacy of Chris Decker. The conference then broke for lunch and each school of pharmacy’s respective luncheon. After lunch, the Wisconsin Pharmacy Residency Showcase gave students at all stages of their pharmacy schooling the opportunity to network and learn about various residency programs across the state of Wisconsin. Residency Program Directors, pharmacy residents, and clinical pharmacy preceptors were available to pharmacy students to answer questions about their program and site, helping students to plan as the year gets closer to internships and the residency application season. Following the showcase, afternoon programming included a wide variety of learning opportunities for pharmacists, students, residents, and preceptors. Pharmacist programming included several clinical and informational sessions including, Allied Against Opioid Abuse: A Toolkit for your Pharmacy and Virtual Ambulatory Pharmacy: Re-engineering our Pharmacy Workforce for the Future. Additionally, student-focused programming included the Student Pharmacists Workshop - Preparing for your Future: National Perspectives on an Evolving Pharmacy Practice Frontier where the panel of speakers, including Sara King, PharmD, Emilee McCullough, PharmD Candidate, Sarah Pagenkopf, PharmD, BCPS, and Allie Jo Shipman, PharmD, MBA, discussed the ever-changing pharmacy landscape and the impact an evolving pharmacy practice frontier can have on student pharmacists as they transition into their careers. Afternoon sessions continued with Supporting your Learners, Providing Project Management Coaching where Andrew Traynor, PharmD, BCPS

discussed how preceptors can help student pharmacists gain the skills required to become effective project managers during school rotations and carry those skills forward into residency and pharmacy careers. The evening concluded with the President’s Reception and Awards Banquet at which the awards for Pharmacist of the Year, Distinguished Service Award, PSW Interdisciplinary Care Partner Award, Young Pharmacist of the Year, Bowl of Hygeia, Excellence in Innovation, Pharmacy Technician of the Year, and the Student Achievement Awards were bestowed upon their respective recipients. This year’s PSW Annual Meeting provided attendees with the opportunity to collaborate and learn from several keynote speakers, clinical practice advancement and information sessions, networking sessions and poster presentations as well as celebrate the life and legacy of Chris Decker. PSW appreciates and thanks the members, staff, sponsors, and presenters for once again making the Annual Meeting a collaborative success to share knowledge and advance pharmacy practice and patient care in Wisconsin. PSW invites you to mark your calendars and attend the upcoming 2020 PSW Educational Conference which will be held at the Monona Terrace and Convention Center in Madison, Wisconsin on April 2-3, 2020! Ryan Simonet is a PGY1 Health System Pharmacy Administration Resident at William S. Middleton Memorial Veterans Hospital in Madison, WI. Samantha Lewiston is a 3rd Year Doctor of Pharmacy Candidate at the University of Wisconsin-Madison School of Pharmacy in Madison, WI.

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WPQC Awards Provided at the Annual Meeting In September at the Annual Meeting, PSW chose to honor 3 pharmacists and 1 pharmacy for the work they have done with the Wisconsin Pharmacy Quality Collaborative (WPQC) this year. One pharmacist and one pharmacy received the WPQC Innovation Award and two pharmacists received the WPQC Engagement Award. The Innovation Award honors pharmacists and practices who have been engaged in WPQC while also demonstrating a passion for innovation. The WPQC Engagement Award honors pharmacists and practices who have been engaged in multiple facets of WPQC. This year, we chose awardees who have made strides in terms of engagement with the Medicaid MTM program, but also with the other programs that PSW/WPQC supports. PSW thanks everyone that participates in the WPQC program for their continued support and perseverance in practice advancement.

WPQC Innovation Awards

Abbi Linde, Beaver Dam Hometown Pharmacy Streu’s Pharmacy (Green Bay) Abbi Linde Beaver Dam Hometown Pharmacy Abbi is co-owner of Beaver Dam Hometown Pharmacy and has not only become engaged in the WPQC WI Medicaid program over the past year, but also has had her resident participate in the United Way CMR events. In addition, Abbi established the very first Diabetes Prevention Program site in a pharmacy in the state! She has utilized her functional medicine and coaching training by creating her own weight loss management program and is also an active member in the Community Pharmacy Enhanced Services Network in Wisconsin (CPESN). She was instrumental in obtaining new Flip the Pharmacy funding for WI CPESN to implement clinical care across a continuum and operationalize the WPQC program. Streu’s Pharmacy (Green Bay) Nicole Schreiner and Gabby Gaura accepted this award on behalf of Streu’s Pharmacy. Streu’s has worked hard this past year to implement processes both in the longterm care side and the community side of their pharmacy business to make providing CMRs a reality. They were one of the participants in the Final Product Verification pilot and were very thoughtful in terms of their approach to systematizing the workflow and have increased their participation in the WPQC program for Medicaid members. Addidtionally, they implemented a unique and innovative way to provide CMRs face to face to patients in the assisted living facility. 54  The Journal

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WPQC Engagement Awards

Karen Roby, Mount Horeb Pharmacy Brad Spross, Lakeside Pharmacy (Antigo)

Karen Roby Mount Horeb Pharmacy Karen is the owner of Mount Horeb Pharmacy, and has been a regular pharmacist providing CMRs at the United Way of Dane County senior and community center events for over 2 years! She makes herself available to help not only at events coordinated at the Mount Horeb senior center but she is also willing to travel to other locations in Dane County when the need arises. In fact, she has become our primary pharmacist for this program! During the last year, she has begun to provide home-based CMRs in her community, both at residential facilities and patient homes.

Brad Spross Lakeside Pharmacy (Antigo) Brad works at Lakeside Pharmacy in Antigo, and began his engagement with WPQC last summer with the WEA Trust Hypertension pilot. He provided a significant number of WEA members hypertension-focused CMRs and was quick to provide many examples of the clinically-relevant interventions that he coordinated with member’s physicians. Since the time of the hypertension pilot, Brad also began to engage in the WI Medicaid MTM program, for which he provided a significant number of CMRs to members. Currently, he is engaged in the cardiovascular comorbidity program through WPQC and WEA Trust.

Below: WPQC Awardees at the PSW Annual Meeting in Green Bay on Friday. September 13, 2019.

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Awards were presented at the 2019 PSW Annual Awards Banquet Saturday, September 14, 2019

PHARMACIST OF THE YEAR

Andrew Wilcox, PharmD William S. Middleton Memorial Veterans Hospital Madison

YOUNG PHARMACIST OF THE YEAR

Edward Portillo, PharmD University of Wisconsin-Madison School of Pharmacy Madison

DISTINGUISHED SERVICE AWARD Dennis Brierton, PharmD, BCPS, FASHP Aurora Health Care Milwaukee

BOWL OF HYGEIA

PSW INTERDISCIPLINARY CARE PARTNER AWARD Tim Bartholow, MD NewGenHealth, WEA Trust Madison

EXCELLENCE IN INNOVATION

John Muchka, PharmD, BCPS Froedtert and Medical College of Wisconsin - Community Memorial Hospital Menomonee Falls

Andrew Traynor, PharmD, BCPS Concordia University Wisconsin School of Pharmacy Mequon

STUDENT ACHIEVEMENT AWARD

STUDENT ACHIEVEMENT AWARD

Jay Urban, PharmD Concordia University Wisconsin School of Pharmacy Mequon

Meredith Frey, PharmD UW-Madison School of Pharmacy Madison

PHARMACY TECHNICIAN OF THE YEAR Sophia Becker, CPhT Gundersen Health System La Crosse

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The Journal 55


Meeting Recap

2019 PSW Presidential Address: Maybe Someday - TEDRx by Mike Gillard, PharmD

G

ood morning fellow pharmacists, technicians and students. I am truly honored and humbled to stand before you as the next PSW President. For those that don’t know me, I’m a proud graduate of the UW-Madison School of Pharmacy and completed a hospital pharmacy residency at UW Hospital and Clinics back when it was a novel idea. I’ve worked nearly all my 26 years of practice in hospitals and healthsystems. In those years, I’ve been in a lot of different roles, such as a clinical pharmacist, a clinical coordinator and a drug policy and medication safety coordinator. I’ve worked at UW Hospital, Aurora Health Care, Froedtert Hospital, and Wheaton Franciscan Healthcare, which is now part of Ascension. For the past 11 years I’ve been the inpatient pharmacy manager at

Ascension Franklin Hospital which is also home to the Midwest Orthopedic Specialty Hospital. All those who know me, know how much I value them as colleagues and friends. Rather than list out everyone Above: Mike Gillard giving his Presidential Address at the 2019 PSW Annual Meeting in by name, I’d like to Green Bay, WI. give a little shout out to Mike Grunske, and I would like to has been led by an amazing staff and thank him for encouraging me to run for great volunteer pharmacy leaders for the president. I also want to thank my family: past 21 years. When I received the call my wife, Debbie, my son, Nathan, and my from Chris Decker that I was elected daughters, Tilly, and Lucy. Thank you for president, my mind quickly thought of your love and support as I step into this this very moment. What would I say for role. my presidential address? Some of you Since its inception in 1998, PSW

FIGURE 1. TED Correspondence

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may recall a special JPSW publication last year, which was a collection of the past 10 years of Presidential speeches during the Annual Meeting. The timing of it coincided with that phone call from Chris. The speeches in that journal are filled with visionary thoughts and inspiring messages. I hoped that I could contribute as well in a meaningful way. During my presidentelect year, I’ve thought a lot about our profession, our organization and my role as incoming president. It dawned on me that I would be giving this talk in Titletown, USA! Talk about the pressure! But my angst subsided while I was up North over Labor Day, watching the local NBC affiliate. A commercial came on for the Packers Pro Shop. As you know, we associate PSW with the theme One Voice – One Vision and the Packers Pro Shop tag line is ONE TEAM – ONE STORE. So, I knew I was in good company here in Green Bay. In thinking about my words today, I’ve always been inspired and entertained by TED talks. I thought, “What about giving a TED talk?” Has everyone seen a TED Talk? Likely on the internet somewhere? Well if you haven’t, TED stands for Technology, Education, and Design. It’s a non-profit company whose mission is to educate and inspire people through ideas. The talks are usually no more than 18 minutes in length and are laser focused on a global issue. TED has a website that is filled with educational and inspiring talks from all over the world. You can find talks on anything from how the sandwich was invented to eliminating the Guinea worm in sub-Saharan Africa. It covers all areas of interest. If you keep browsing, you’ll notice there are a ton of affiliated TEDlicensed talks. This includes TEDx, which are organized independently under a free license granted by TED. The talks are more locally focused but always cover one idea. There’s also TED Ed, TED Books, and many more. There’s even TEDMED, which focuses on health and medicine. TEDMED charges nearly $4000 to attend their annual event. I thought to myself, why not TED-Rx? I wouldn’t charge $4000, just the registration fee for the PSW Conference! TED-Rx could be all about pharmacy. So, I emailed TED from their website and asked if TED-Rx existed and if I could utilize that idea as a platform for this speech! Sadly, I www.pswi.org

FIGURE 2. PSW Full Membership & Technician Membership

received the following email reply (Figure 1). The bottom line was that they were flattered for the request and thanked me for enjoying their content, but without a TED license, they strongly encouraged me not to use TED-Rx. See my idea isn’t just about one single topic, and since they aren’t endorsing the idea, they can’t ensure the integrity of the material. So, unfortunately, I can’t do this… But if I was to do it, I’d change up the meaning of the mnemonic letters. The letters wouldn’t represent Technology, Education and Design. Each letter would represent words that are important to our profession here in the state of Wisconsin.

So, let’s start!

T is for Technician

Over the years, we have asked our Pharmacy Technicians to take on new tasks and new roles. What started out as an assistant or perhaps a delivery person has continuously evolved. In the 80’s and ‘90’s we had technicians entering orders into computer systems, making IV medications, or even administering oral medications and subcutaneous injections. They have been restocking dispensing cabinets in hospitals, they are customer service specialists, and often the face of a pharmacy. Some take medication histories from patients, process November/December 2019

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Now the challenge we have is that the current state legislature is not very inclined to pass additional regulation. Over the past few years they have had an interest in deregulation and eliminating licenses deemed unnecessary. I hope you feel this regulation is necessary. We need to fully support this bill, which demonstrates the importance of the next letter in our TEDRx word play, the Letter E.

E is for Engagement

Above: Mike Gillard (second from the right) and Chris Decker (third from the right) celebrating with the Executive Committee of the PSW Board of Directors at the 2018 PSW Annual Meeting at the Kalahari Resort & Convention Center in the Wisconsin Dells.

prescriptions, manage inventory, and submit claims for additional reimbursement for comprehensive medication reviews. This has resulted in a wonderful expansion of pharmacy technicians into certain subspecialties and in certain practice settings. The US Department of Labor, Bureau of Labor Statistics from 2016 and 2018 reported that the national average for job growth outlook for all jobs is 7%.1 Pharmacy technicians are at 12%. They predict there will be an additional 47,600 US jobs created for pharmacy technicians by 2026. Currently in the state of Wisconsin the number of technicians as of May 2018 is around 8000. Some very impressive numbers but they are only approximate. Our own PSW membership reflects the storyline. Here’s the Pharmacy Technician Membership growth of 2015 (Figure 2). Pretty flat, right? Well put that together through August of 2019, and you see that there has been a nice steady rise in numbers. The most interesting point to me is the big jump in October of 2018. PSW received corporate or business memberships from several health-systems, such as Froedtert & Community Health, Gunderson Lutheran, SSM Health, Aurora, to name a few. This means these health-systems are paying the membership dues for all pharmacists and all technicians. Even my own healthsystem, Ascension is providing a corporate membership for its lead pharmacists and technicians. 58  The Journal

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Now there is more to be learned from this. Remember this graph depicts just technician memberships numbers (Figure 2). The health-systems didn’t have to include technicians in their membership payment, but they did. They CHOSE to. To me this demonstrates important and active recognition of pharmacy technicians and the role they play in health-systems. Who won the 2019 PSW Good Governance Award this past spring at Legislative Day? Jane Barton, a former pharmacy technician at UW Hospital & Clinics, who is now the staff development supervisor! I’m confident in stating our profession would not be where it is today, without the presence of talented pharmacy technicians. This is so important we will have a bill that we hope to pass this fall to register pharmacy technicians in the state of Wisconsin. Wisconsin is one of only 6 states that don’t require registration of pharmacy technicians.2 In fact, it wasn’t until a couple of years ago that pharmacists were granted oversight of a technician’s work. So why is registration so important? It would be a clear sign that technicians are vital to the profession and gives them external recognition. It is also another way to ensure the quality and caliber of a pharmacy technician. Finally, the Pharmacy Technician Registration law would provide oversight by the Pharmacy Examining Board and give them the authority to grant, suspend or revoke the registration.

PSW has grown total membership by 14% over that last 4 years. Again the health-system corporate memberships are a big part of this growth. Now would have been a great time to talk about how we routinely break attendance records at our meetings, but this one didn’t. I realize with the Packer game tomorrow, it was tough to get a hotel room for tonight. But It is amazing and wonderful that all of you are here today. I want to thank you for that! When we talk about engagement, we have to go beyond meeting attendance. We must talk about other forms of active membership and what that should or could mean. The PSW website has a very nice infographic on the Membership Involvement Ladder (see page 60). There are many examples for active or engaged memberships. Yes, attending meetings is active. And so is reading Fast Facts or reading The Journal. I received a text from a pharmacist friend of mine to let me know he thought there was a typo in an article of the journal! Now that is great engagement. Other ways include offering to be a speaker or submit a poster for a meeting or an article for The Journal. Still other ways could be connecting with a member of the PSW Board of Directors in your region. Asking for a site-visit or to meet for a cup of coffee. I have Pat Cory to thank for flagging me down at an Educational Conference 6 years ago to ask if I would consider running for a board position. So many ways to be an ACTIVE member of PSW. Now we have over 2800 voting members in PSW. Yet only a little over 300 members voted in our PSW officer election this past year, or around 12% of our membership. That number has remained consistent for the last 10 years. I emphasize this because if we are going to obtain support of our Pharmacy www.pswi.org


Technician Bill, we have to convince our legislators. As a pharmacist or technician, we need to know who our state politicians are, and they should know who you are. That is why we have Legislative Day at the Capital every year. That is why we need members, especially corporate members, to KNOW that they are PSW members and why they are PSW members. So Local engagement with your State Senator or Assembly person is so terribly important! But it shouldn’t stop there! A recent article in the Milwaukee Journal-Sentinel on August 26th of 2018 called out that nearly 30% of Wisconsin pharmacists surveyed were unaware that naloxone was available without a prescription under the State Standing Order. Engagement needs to extend beyond the political landscape, to include the public media landscape. Some may argue that we need to get those 30% surveyed to be members of PSW! But in addition we need to engage our local papers and television stations so that they look to us, PSW members, whenever there is a need or an ask for a pharmacy related story. As a side note, PSW was not consulted about this article. So ENGAGEMENT is vital to our profession for both pharmacists and technicians.

Chris believed in PSW. We are all here not because we have to be, but because we want to. That is the essence of Chris. He inspired everyone he met. So while D is for Decker, it is also for DIRECTION. Chris set us on a fantastic path. And together we will continue to move PSW in a forward DIRECTION. Thank you!

References

1. Bureau of Labor Statistics, U.S. Department of Labor. Occupational Outlook Handbook, Pharmacy Technicians. www.bls.gov/ooh/healthcare/pharmacytechnicians.htm. Accessed August 13, 2019. 2. Draime JA, Anderson DC, Anderson TS. Description and comparison of medication diversion in pharmacies by pharmacists, interns, and pharmacy technicians. J Am Pharm Assoc. 2018;58(3):275-280.

Mike Gillard is the President of the Pharmacy Society of Wisconsin in Madison, WI.

CORPORATE PARTNERS & CONFERENCE SPONSORS PSW PLATINUM PARTNERS

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D is for...

Well, D of course, is for Decker, Chris Decker, whose whole professional life was devoted to this organization. Over the last several weeks, including this morning, we celebrated him with stories and pictures and memories. There is a fabulous TED talk from a TEDWomen 2018 talk, see there’s a ton of them, just no TEDRx …..YET! In the talk, author Nora McInerny delivers a very poignant speech whose main theme really sums up our lives with Chris Decker. I don’t want to give away too much of her talk, but the main theme is about moving forward in the face of grief, not moving on from it. It’s about making it ok to remember someone often, after they die. I strongly encourage everyone to watch it! So we shouldn’t MOVE ON from him, but move forward with him. Chris was innovative and entrepreneurial. Our organization is flourishing because of his leadership and vision. I believe in PSW, because www.pswi.org

November/December 2019

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60  The Journal

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Pharmacy Reflections

The Future… by Nicholas Olson, PharmD, BCACP, AAHIVP

T

here are ideas that invoke such a spectrum of emotion as the idea of what the future can hold. Discussions about the future induce palpable feelings of excitement, intrigue and optimism. The possibilities that a future can hold will energize a passion and enthusiasm in individuals to endeavor to build a future that strives towards those possibilities. Unfortunately though, sometimes the future isn’t so clear. It may not inspire clarity or sense of purpose. It can easily induce anxiety or a sense of uncertainty that temper individuals from taking positive initiative and stifles creativity and inspiration. As my PSW Board Service time has come to a close I have found myself reflecting as to what the future for PSW holds. Our organization is entering into a time of transition and with that a degree of uncertainty is surely to follow. I find myself questioning the courses of action we took and wondering about the roads not taken. Did we do enough? Did we push hard enough? Did we push too hard? Are our members finding value? Is our profession heading in the right direction? During these moments of self-doubt I have learned to turn to the most valuable asset this organization has to offer for answers- its members. In my conversations with PSW members over the past few months I have asked what their thoughts are on the future of our organization and our profession. Their answers were robust, diverse and, perhaps most importantly, exceptionally positive. The following is just a sample of the positive reflections I received on PSW’s accomplishments: • Progression of technician advancement including legislation developed around technician registration and delegation. Formalizing technician final product verification into state law and seeing nearly a doubling of our technician membership. • The completion of a PSW headquarters remodel that physically

www.pswi.org

embodies the rich history of our organization as well as it will connect and support the generation of pharmacists to come. • The corresponding capital campaign that raised $500,000 to support the future of our profession and this organization as well as the additional $100,000 raised by pharmacists outside of the organization, demonstrate the generosity and absolute belief that people have in the mission of PSW and the people that engage with it. • PSW has commissioned work groups to develop poignant strategies to address some of the most challenging issues facing the profession including: provider status, community pharmacy payment reform, practice advancement, drug pricing and PBM reform. • In the past few years PSW has seen record membership, record contributions to our political action conduit and increased national recognition for our work in population health initiatives. • PSW held its inaugural Wisconsin Pharmacy Residency Conference which saw over 100 pharmacist residents from across the state come together to present their research and practice advancement initiatives. • PSW has seen the development of an ambulatory pharmacist advisory committee to help support and promote the practice issues within this rapidly growth space in pharmacy. As well as, we have seen a resurgence in the chain pharmacy advisory group. • PSW has persevere through the loss of a leader, mentor and friend to all in a way that would have made him proud. This list could go on and it will go on as PSW continues to work and strive towards the future our members envision. It is without doubt that we had some missteps along the way and opportunity was left on the table, but PSW is an organization of good and talented people working and acting in good faith towards the “One Voice and One Vision” of Wisconsin pharmacy. With the belief in that fundamental tenet of our organization, I am confident that PSW will endure and

its future is and always will be bright and strong. For the last three years, as involved as I have been with this organization, not a day has gone bye when I interact with a PSW colleague that I don’t walk away with something new. Recently, the PSW board of directors got together to discuss what the next steps would be to guide us into the future. At that meeting, a board member said it best when she said “We are an organization of members serving members”. It was a simple statement but profound in impact as I have never heard PSW’s culture described in such a way. So with this culture of “members serving members” in mind, I ask you all to continue your work with this organization; continue your work in advancing this profession; please continue serving your colleagues, learners and patients with the same passion and zeal PSW members are known for. Reach out to a colleague and personally invite them to become engaged. Presenting someone with an opportunity to serve reaches to the very core of what the profession of pharmacy is about. Serving you all through PSW has been a great honor and privilege. I look forward to our continued work together and addressing all of the opportunities and challenges to come our way. I look forward to the future… Nicholas Olson is the Manager of Ambulatory Pharmacy at Froedtert Health in Milwaukee, WI. November/December 2019

The Journal 61


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Statement of Ownership, Management, and Circulation (All Periodicals Publications Except Requester Publications)

1. Publication Title

2. Publication Number

The Journal of the Pharmacy Society of Wisconsin 4. Issue Frequency

Every 2 months

1 0 9 8

_

9/19/2019

1 8 5 3

5. Number of Issues Published Annually

6. Annual Subscription Price

6

$90/ year

7. Complete Mailing Address of Known Office of Publication (Not printer) (Street, city, county, state, and ZIP+4 ®)

Contact Person

The Journal of the Pharmacy Society of Wisconsin

15. Extent and Nature of Circulation

608-827-9200

Pharmacy Society of Wisconsin 701 Heartland Trail Madison, WI 53717 9. Full Names and Complete Mailing Addresses of Publisher, Editor, and Managing Editor (Do not leave blank) Publisher (Name and complete mailing address)

Pharmacy Society of Wisconsin 701 Heartland Trail Madison, WI 53717

Average No. Copies No. Copies of Single Each Issue During Issue Published Preceding 12 Months Nearest to Filing Date

a. Total Number of Copies (Net press run) (1) Mailed Outside-County Paid Subscriptions Stated on PS Form 3541 (Include paid distribution above nominal rate, advertiser’s proof copies, and exchange copies)

Telephone (Include area code)

8. Complete Mailing Address of Headquarters or General Business Office of Publisher (Not printer)

b. Paid Circulation (By Mail and Outside the Mail)

(2)

Mailed In-County Paid Subscriptions Stated on PS Form 3541 (Include paid distribution above nominal rate, advertiser’s proof copies, and exchange copies)

(3)

Paid Distribution Outside the Mails Including Sales Through Dealers and Carriers, Street Vendors, Counter Sales, and Other Paid Distribution Outside USPS®

(4)

Paid Distribution by Other Classes of Mail Through the USPS (e.g., First-Class Mail®)

c.  Total Paid Distribution [Sum of 15b (1), (2), (3), and (4)]

Editor (Name and complete mailing address)

Megan Grant 701 Heartland Trail Madison, WI 53717

d. Free or (1) Free or Nominal Rate Outside-County Copies included on PS Form 3541 Nominal Rate Distribution (2) Free or Nominal Rate In-County Copies Included on PS Form 3541 (By Mail and Free or Nominal Rate Copies Mailed at Other Classes Through the USPS Outside (3) (e.g., First-Class Mail) the Mail)

Managing Editor (Name and complete mailing address)

Amanda Margolis 701 Heartland Trail Madison, WI 53717

10. Owner (Do not leave blank. If the publication is owned by a corporation, give the name and address of the corporation immediately followed by the names and addresses of all stockholders owning or holding 1 percent or more of the total amount of stock. If not owned by a corporation, give the names and addresses of the individual owners. If owned by a partnership or other unincorporated firm, give its name and address as well as those of each individual owner. If the publication is published by a nonprofit organization, give its name and address.) Full Name Complete Mailing Address

701 Heartland Trail, Madison, WI 53717

(4)

Free or Nominal Rate Distribution Outside the Mail (Carriers or other means)

e. Total Free or Nominal Rate Distribution (Sum of 15d (1), (2), (3) and (4))

f. Total Distribution (Sum of 15c and 15e)

g. Copies not Distributed (See Instructions to Publishers #4 (page #3))

h. Total (Sum of 15f and g) i. Percent Paid (15c divided by 15f times 100) 11. Known Bondholders, Mortgagees, and Other Security Holders Owning or Holding 1 Percent or More of Total Amount of Bonds, Mortgages, or None Other Securities. If none, check box Full Name

14. Issue Date for Circulation Data Below

9/1/2019

Megan Grant

Pharmacy Society of Wisconsin 701 Heartland Trail Madison, WI 53717

Pharmacy Society of Wisconsin

13. Publication Title

3. Filing Date

2910

2875

2631

2588

2631

2588

8

8

260

260

268

268

2899

2856

11

19

2910

2875

97.6%

90.6%

* If you are claiming electronic copies, go to line 16 on page 3. If you are not claiming electronic copies, skip to line 17 on page 3.

Complete Mailing Address

12.  Tax Status (For completion by nonprofit organizations authorized to mail at nonprofit rates) (Check one) The purpose, function, and nonprofit status of this organization and the exempt status for federal income tax purposes: Has Not Changed During Preceding 12 Months Has Changed During Preceding 12 Months (Publisher must submit explanation of change with this statement) PS Form 3526, July 2014 [Page 1 of 4 (see instructions page 4)] PSN: 7530-01-000-9931

PRIVACY NOTICE: See our privacy policy on www.usps.com.

PS Form 3526, July 2014 (Page 2 of 4)

Statement of Ownership, Management, and Circulation (All Periodicals Publications Except Requester Publications) 16. Electronic Copy Circulation

Average No. Copies Each Issue During Preceding 12 Months

No. Copies of Single Issue Published Nearest to Filing Date

a. Paid Electronic Copies b. Total Paid Print Copies (Line 15c) + Paid Electronic Copies (Line 16a) c.  Total Print Distribution (Line 15f) + Paid Electronic Copies (Line 16a) d. Percent Paid (Both Print & Electronic Copies) (16b divided by 16c Í 100)

I certify that 50% of all my distributed copies (electronic and print) are paid above a nominal price. 17. Publication of Statement of Ownership If the publication is a general publication, publication of this statement is required. Will be printed

Publication not required.

Nov/Dec 2019 in the ________________________ issue of this publication. 18. Signature and Title of Editor, Publisher, Business Manager, or Owner

Date

9/19/2019 I certify that all information furnished on this form is true and complete. I understand that anyone who furnishes false or misleading information on this form or who omits material or information requested on the form may be subject to criminal sanctions (including fines and imprisonment) and/or civil sanctions (including civil penalties).

Editors Note: PSW is required by law to reprint our USPS data for The Journal of the Pharmacy Society of Wisconsin in one issue every year.

64  The Journal

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Volume 22

NOVEMBER/DECEMBER 2019 • VOLUME 22 • ISSUE 6

SEE PAGE 49 FOR DETAILS

THE JOURNAL OF THE PHARMACY SOCIETY OF WISCONSIN

RETURN S ERV ICE RE QUES TE D

Issue 6 www.pswi.org

November/December 2019

2019 PSW Annual Meeting Recap

Pediatrics


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