North Carolina Pharmacist Volume 97 Number 2 Spring 2017 A d v a n c i n g P h a r m a c y. Im p r o v i n g H e a l t h .
NCAP Legislative Day Review Chronic Care Practice Forum Update From the New Practitioner Network Advocacy Fund Supporters Education and Practice
Pharmacy Legislative Day On March 22nd, NCAP in collaboration with ACP and NCRMA sponsored a very successful Pharmacy Legislative Day. Look inside for an update on important state legislative initiatives impacting pharmacy.
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Official Journal of the North Carolina Association of Pharmacists 1101 Slater Road, Suite 110 Durham, NC 27703 Phone: (984) 439-1646 Fax: (984) 439-1649 www.ncpharmacists.org Click Here to Follow us! -
North Carolina Pharmacist Volume 97 Number 2
Spring 2017
Inside JOURNAL STAFF EXECUTIVE EDITOR Penny Shelton EDITOR/STAFF WRITER Ralph Raasch LAYOUT/DESIGN Rhonda Horner-Davis
BOARD OF DIRECTORS PRESIDENT Stephen Eckel PRESIDENT-ELECT Stefanie Ferreri PAST PRESIDENT Ashley Branham TREASURER Thomas D’Andrea
BOARD MEMBERS Olivia Bentley Jamie Brown Jennifer Burch David Catalano Lisa Dinkins Ouita Gatton Stephen Kearney Macary Marciniak Kim Nealy Dave Phillips Justin Reid Jennifer Wilson
NCAP STAFF Linda Goswick Sandie Holley Rhonda Horner-Davis Teressa Reavis Ron Williamson North Carolina Pharmacist (ISSN 0528-1725) is the official journal of the North Carolina Association of Pharmacists. An electronic version is published quarterly. The journal is provided to NCAP members through allocation of annual dues. Opinions expressed in North Carolina Pharma-
•From the Executive Director .............................................................5-6 •Legislative and Advocacy Update...........................................................8-9 •Legislative Day.......................................................................11-12 •NCAP Members for Office.............................................................13 •Call for Nominations................................................................................14 •Call for Abstracts..........................................................................15-16 •Call for Roundtable Facilitators.................................................17 • Chronic Care Practice Forum Update and Awards................................18-19 • From the New Practitioner Network.....................................................21-26 •Education and Practice.................................................................28-31 •Research.......................................................................................32-36 •Case Report.................................................................................38-43 •Entrepreneurship.................................................................................44 •In Memory.......................................................................................45
North Carolina Pharmacist is supported in part by: • Smith Drug Company................................................................................................2 • Pharmacists Mutual Companies...............................................................................7
• Epic RX....................................................................................................................16
• Pharmacy Technician Certification Board...............................................................20 • NCAP Career Center...............................................................................................27 • Pharmacy Quality Commitment..............................................................................37
• VIP Pharmacy Systems............................................................................................46
cist are not necessarily official positions or policies of the Association. Publication of an advertisement does not represent an endorsement. Nothing in this publication may be reproduced in any manner, either whole or in part, without specific written permission of the publisher.
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For rates and deadline information, please contact Rhonda Horner-Davis at rhonda@ncpharmacists.org
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Congratulations, New Graduates! Let us help you make the transition into your Pharmacy future! NCAP is offering a special package that includes an NC MPJE Law Review Book along with a first-year membership for $99. Join online at ncpharmacists.org to receive your Law Review Book mailed to you with an additional $10 shipping and handling fee. We look forward to being a part of your future, and together we can make a difference for our profession.
*Book sold separately by NCAP for $99 + S&H
Advancing Pharmacy. Improving Health
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•From the Executive Director• Penny Shelton, PharmD, CGP, FASCP
Executive Director Update: Spring 2017 Penny Shelton The last day of this month will mark the end of my first year as your Executive Director. To commemorate what has perhaps been one of the fastest years of my life, I thought I would use this column to provide an update on what has been going on within the Association. First, you should know that your Board of Directors has set forth a strong strategic plan for our organization, and they have been meeting monthly to provide appropriate oversight and guidance. The committees that we launched in January are working diligently on their charges and beginning to make a significant impact. The Membership Committee and the Board of Directors have a number of membership recruitment and retention initiatives in progress now. The Practice Forums have challenged each other to a membership drive. I have been making rounds to visit with health systems and local pharmacy associations to seek input, feedback and to encourage NCAP membership at the local or regional level. We have
launched a project team to explore how to make membership more attractive to pharmacy technicians. We have spent time planning for how to retain student pharmacists during their final year of school and after graduation. We are close to launching new messaging that is packaged with specific resources to capture pharmacists reciprocating to our State. Finally, we have created a project team to work on reactivating a North Carolina pharmacy leadership council. The more we can engage and serve the leadership in our profession, the more we will be able to demonstrate meaningful value, which attracts membership.
and mentoring programs. Since the Committee has completed some of their prioritizing task, NCAP staff has begun looking at recommended website changes, including exploring potential new vendors. The “find a member” directory has been developed, and we are working on some new infographics for new and existing members. In the area of new resources, the Association has recently partnered with Dr. Geoff Mospan, who teaches pharmacy law at Wingate University, to create an NCAP study guide for the NC MPJE as an offering for new graduates and pharmacists from other states seeking licensure in North Carolina.
The Resource Development Committee is working on completing a review and comparison of our website. In addition, the Committee has identified and prioritized ten resources, tools and services for NCAP to provide for members. In their work they have identified a need for NCAP to develop a more visually appealing, user-friendly and interactive website for the Association. In addition, they have outlined improvements in areas that include things like: a) find a member directory, b) infographics on how members can get involved, c) interactive networks which allow members with similar interests to connect, d) improvements in the number and diversity of job listings in the career center, and e) new resources such as leadership
The Education Committee, using several special project teams, has made significant strides in moving NCAP toward developing a repository of on-demand webinar programs. They are working on the development of several new webinars, and as Executive Director I have been exploring new partnerships to help the Committee build what will be an NCAP on-demand library of continuing education offerings. The Education Committee is also working on major programming changes to our annual convention to be held September 22-24 at the Benton Convention Center in Winston-Salem. In this issue you will find an article by Dr. Cody Clifton, a member of our Policy and Advocacy Committee. Cody shares a sum5
mary and his impressions of our Pharmacy Legislative Day held in March. The Policy and Advocacy Committee was instrumental in handling many of the logistics for that event, plus they have been continuing to meet regularly to help with our communications and grassroots initiatives around both federal and state pharmacy legislative issues. If you have been following the information provided in our electronic newsletters, then you know we have been actively supporting federal bills on PBM transparency and provider status. We have also been supporting NC bills filed this session around the opioid epidemic, criminal background checks prior to pharmacist licensure, and consumer protections outlined in the Pharmacy Patient Fair Practices Act. Finally, we have been
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working quite hard to garner support around the expansion of collaborative practice in our state. As we continue our work on collaborative practice authority to prepare for the short session in 2018, this summer and fall you will be hearing much more, and I hope that you will respond to our calls to action. Finally regarding our advocacy work, NCAP has invested in a new platform called “Muster.” This technology makes it super simple for the Association to push a “please write your legislator” call to action to you along with a pre-typed message. In order for us to optimally benefit from having this technology, we need help in procuring your essential information such as an accurate cell phone number and email address, as well as your home address, so we can match members with their correct leg-
islators. In the coming days, we will be asking members and others in our database to provide this essential information, we hope that you will respond quickly so that we can use “Muster” to help with provider status, PBM, collaborative practice and other important profession issues. As we get closer to my one-year anniversary, I want you to know how much I have enjoyed this first year making new connections and working with amazing NCAP members who are helping bring new energy, enthusiasm and meaningful change and value to our Association and our profession statewide. As always, “Pharmacy Proud,” Penny
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Legislative and Advocacy Updates May 2, 2017
April 18, 2017
H.243/S.175 Strengthen Opioid Misuse Prevention Act The bill was passed unanimously in the House on 4/10/2017 and passed over to Senate where it was referred to the Rules Committee on 4/11/2017.
Expansion of Collaborative Practice Authority The Legislators have been on a short break and are returning to session tomorrow. As most of you know, NCAP has been working towards getting a bill introduced to help expand our collaborative practice authority. We are seeking to bring about changes that would make it easier for physicians and pharmacists to work together under collaborative practice agreements. These changes would broaden the use of clinical pharmacist practitioners in health systems as well as help expand collaborative care into the community setting, where to date very few clinical pharmacist practitioners work despite our current statute dating back to 1999.
H.466/S.384 Pharmacy Patient Fair Practices Act These are the bills addressing consumer and pharmacy protections as part of PBM regulation. The bills were passed in both the House and Senate late last week. Each has been sent to the other chamber for concurrence. S. 104/ H. 708 Require Criminal Background Check/Pharmacist Licensure This bill passed in the Senate and was sent over to the House where H. 708 was read in and referred to the House Rules Committee. Expansion of Collaborative Practice Authority We were unable to make the filing deadline to introduce our bill into the House this session. The deadline was April 25th. However, we have made great strides in gaining support. Tony Adams, NCAP Lobbyist, was able to get the very influential Reps. Josh Dobson, Donny Lambeth, Chris Malone and Jonathan Jordan to agree to be primary sponsors. NCAP plans to launch a grassroots educational and advocacy initiative around this bill beginning Summer 2017 with plans to file in the next legislative session. Stay tuned for how you can help garner more support for helping advance collaborative care in North Carolina.
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Currently, NCAP lobbyist Tony Adams is working very hard to garner sponsorship to introduce our bill. Rep. Greg Murphy in the NC House is the only physician in the legislature and, unfortunately, he remains opposed. We are calling on pharmacists and physicians who currently work via collaborative agreement to call or write Rep. Murphy to share your experiences and to convey why the expansion of collaborative practice is important to patient care. The Strengthen Opioid Misuse Prevention (STOP) Act (H 243/S175) H.243 passed the House in unanimous vote last week and has been referred to the Senate where it has been assigned to the Rules Committee. NCAP is in support of this bill and requests that members reach out to their legis-
lators in the NC Senate to ask for their support of S.175. Visit the Government Affairs tab on the NCAP website for more information about this bill. The Pharmacy Patient Fair Practices Act (H466 / S384) Both the House and Senate versions are to be reviewed in Committee this week. These bills address PBM regulations and contain much needed consumer protections as well as pharmacist/pharmacy protections from unfair business practices that are harming both community and long-term care patients and pharmacies. The bills have opposition from pharmacy benefit management companies, and the large lobbying firm McGuireWoods is actively working against these bills. Now is the time
for pharmacists to speak out by contacting their NC representative and senator to garner support for H.466 and S.384, respectively. Require Criminal Background Check / Pharmacist Licensure (S104) This bill has passed the Senate Health Care Committee and has been re-referred to the Senate Judiciary Committee. If it successfully gets through this Committee, the bill will be sent on to the Rules Committee. NCAP is in support of this bill.
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NCAP ADVOCACY FUND Thank you to our 2017 Contributors for supporting ongoing legislative monitoring, lobbying and grassroots advocacy for pharmacy.
Goal $20,000 Advocate $150 +
Supporter $100 - $149
Sara Boss-Isenhour Jamie Brown Jennifer Burch Stefanie Ferreri Ouita Gatton William L. Harris, Jr. Mollie Scott Penny Shelton Tom Thutt Jenn Wilson
Olivia Bentley Harry and Diane Brogden Ronny Buchanan Vincent Gaver Mark Gregory Whit Moose, Sr. Heidi and David Phillips Benny Ridout Susan Fowler Stafford Charles M. Whitehead
Click here to Donate today!
$3,095
Advocate/Facilitator Legislative Day paid registrants who also facilitated a session
Friend $50 - $99 Steven Evans Nellie Jones
Ashley Abode Evan Frasure John Kessler Elliott Sogol Ben Urick Davie Waggett
Student $5+ Nik Lawson
Help us reach our goal by donating today at www.ncpharmacists.org 10
Legislative Day
2017 NCAP Legislative Day Review Pharmacists, student pharmacists, and pharmacy technicians from a variety of practice settings and schools united as a profession in Raleigh on March 22, 2017 to advocate for numerous issues that influence patient care, pharmacists, and pharmacies. The day was highlighted with legislative meetings, the student pharmacists-led health fair, facilitated discussion groups, and a reception at the North Carolina Museum of History. The NCAP Policy and Advocacy Committee scheduled appointments with legislators for 37 pharmacists and student pharmacists, along with additional appointments being conducted throughout the day that were not scheduled by the committee. Approximately 90 attendees, consisting of equal numbers of pharmacists and student pharmacists, met with 33 Senators and Representatives as individuals or groups to advocate for pharmacyrelated issues. Among these were the Strengthen Opioid Misuse Prevention (STOP) Act (H.243/S.175), the Pharmacy Patient Fair Practices Act (H.466/S.384), Require Criminal Background Check/Pharmacist Licensure Bill (S.104), and the importance of pharmacists’ collaborative practice authority expansion. H.243 passed the House on April 10, 2017 and passed to
the Senate as S.175, where it was referred to the Rules Committee on April 11, 2017. H.466 and S.384 passed the House and the Senate on April 26, 2017 with each being sent to the appropriate chamber for concurrence. In order to continue following the updates on the bills, please visit the North Carolina General Assembly website (www.ncleg.net). Near the top right of the website, you may type in the bill number to see the most updated status of the bill. While legislative meetings were being conducted, student pharmacists led the charge, under direct supervision of licensed pharmacists, in offering pointof-care testing and providing education surrounding diabetes, hypertension, medication disposal/storage, contraception, opioid abuse and naloxone, and immunizations. Additionally, student pharmacists provided legislators and staffers with advocacy briefs, which discussed the role of a pharmacist in the respective provision of care. The NCAP Student Pharmacist Network was well represented with student pharmacists from The University of North Carolina Eshelman School of Pharmacy, Wingate University School of Pharmacy, Campbell University College of Pharmacy and Health Sciences, and High Point University Fred Wilson School of Pharmacy. Student pharma-
cists’ presence is fundamental in Pharmacy Legislative Day as their activities demonstrate the value of pharmacists’ clinical services and allow for the discussion of advocacy issues. Upon completion of the events at the Legislative Building, pharmacists attended facilitated discussion groups which encompassed numerous topics from a variety of practice settings. Topics included Pharmacists’ Role in the Opioid Epidemic, CPESNUSASM: Revising the Community Pharmacy Practice Model, Reimbursement for Pharmacy Services, Developing and Maintaining Transitions in Care Services, Current Issues with Biosimilars, Naloxone Standing Order Implementation and Practice Challenges, Areas of Potential Community Pharmacists Expansion via Protocols/Standing Orders, and Quality Metrics Impact on Pharmacy Practice. The Policy and Advocacy Committee is reviewing discussion notes for each topic to distinguish resources, education, and grassroots advocacy for which NCAP may be able to assist. We thank all who were involved with making this a successful Pharmacy Legislative Day, including pharmacists and student pharmacists who attended to advocate for our profession and to display clinical services that we offer. We greatly appreciate our sponsors who ensured the event’s success: The Associa11
tion of Community Pharmacists, The North Carolina Association of Pharmacists, and The North Carolina Retail Merchants Association. The Policy and Advocacy Committee looks forward to serv-
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ing you and our profession. Please contact Cortney Mospan (c.mospan@wingate.edu), committee chair, if we can assist in any way. Several pictures from Pharmacy Legislative Day follow.
Cody Clifton, PharmD, is a PGY1 Community Pharmacy Resident at Moose Professional Pharmacy and The UNC Eshelman School of Pharmacy.
NCAP Members for Office
NCAP MEMBERS SERVING IN NATIONAL LEADERSHIP POSITIONS
NCAP is proud to have members who are active in national pharmacy organizations and are frequently elected/appointed to leadership positions. Please keep NCAP informed so we can share the news with our membership. We congratulate the following: Paul W. Bush, MBA, BCPS, FASHP, Chief Pharmacy Officer, Duke University Hospital, will be installed as President of ASHP on June 6.
Stephen F. Eckel, PharmD, MHA, BCPS, Associate Dean for Global Engagement and Clinical Associate Professor, UNC Eshelman School of Pharmacy, began serving a four-year term on the ASHP Board of Directors in the fall of 2016.
Cortney M. Mospan, PharmD, BCACP, BCGP, Assistant Professor of Pharmacy, Wingate University School of Pharmacy, is currently serving as Chair, New Practitioner Advisory Committee, APhA New Practitioner Network and is Coordinator-Elect, Preceptor SIG, APhA Academy of Pharmacy Practice and Management (both positions March 2017-March 2018).
CANDIDATES FOR NATIONAL LEADERSHIP POSITIONS
Rebecca W. Chater, RPh, MPH, FAPhA, Executive Healthcare Strategist, Atec, Inc., is a candidate for APhA President-Elect, 2018-19. Voting for this position ends May 22, 2017.
Two NCAP members are candidates for office in the ASHP elections to be held in late June: Mollie A. Scott, PharmD, BCACP, FASHP, Regional Associate Dean, UNC Eshelman School of Pharmacy, is a candidate for Chair, Section of Ambulatory Care Practitioners.
Robert P. Granko, PharmD, MBA, Director of Pharmacy, Moses Cone Hospital, is a candidate for Director-at-Large, Section of Pharmacy Practice Managers.
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Call ForNominations
NCAP ELECTION AND AWARDS – 2017 ELECTION Deadline: June 15, 2017 NCAP members interested in serving on the NCAP Board are invited to submit their bios by June 15. NCAP Board of Directors NCAP will elect a President-Elect (to serve as President in 2019), Treasurer and one At-large Board Member (3-year terms). Please send bio to Stephen Eckel (seckel@unch.unc.edu)
AWARDS Deadline for Nominations: June 15, 2017 It is a privilege for the North Carolina Association of Pharmacists to recognize excellence within the profession. NCAP members are invited to nominate deserving members for the following awards to be presented at the Annual Convention. Nominations must be in writing (see nominations form on the website www. ncpharmacists.org or you may request one from Linda Goswick). Send nominations to the NCAP Awards Committee, c/o Linda Goswick, 1101 Slater Road, Suite 110, Durham, NC 27703; FAX 984-439-1649; or e-mail to: linda@ncpharmacists.org Bowl of Hygeia Award (sponsored by American Pharmacists Association Foundation and National Alliance of State Pharmacy Associations) Criteria for this award are: (1) Licensed to practice pharmacy in NC; (2) Has not previously received the Award; (3) Is not currently serving nor has he/she served within the immediate past two years on its awards committee or as an officer of the Association 14
in other than an ex officio capacity; (4) Has compiled an outstanding record of community service, which, apart from his/her specific identification as a pharmacist, reflects well on the profession. Cardinal Health Foundation Rx Champions Award (sponsored by Cardinal Health) This award recognizes a pharmacist for his/her work within the pharmacy community to raise awareness of the serious public health problem of prescription drug abuse. Don Blanton Award Presented to the pharmacist who has contributed most to the advancement of pharmacy in North Carolina during the past year. This award was established by Charles Blanton in memory of his father, Don Blanton, who served the North Carolina Pharmaceutical Association as President 1957-58. Excellence in Innovation Award (sponsored by Upsher-Smith Laboratories) Presented to a pharmacist practicing in North Carolina who has demonstrated Innovative Pharmacy Practice resulting in improved patient care. Distinguished Young Pharmacist Award (sponsored by Pharmacists Mutual Companies) Criteria for this award are: (1) Entry degree in pharmacy received less than 10 years ago (2007 or later graduation date); (2) Licensed to practice pharmacy in NC; (3) Actively practices retail, institutional, managed care or consulting pharmacy; (4) Participates in national pharmacy associations, professional programs, state association activities and/or community service. Please send nominations for this award to Olivia Bentley, Chair of the New Practitioner Network (olivia@ rxclinicpharmacy.com)
Call For Abstracts NCAP Annual Convention to Hold its Second Annual Poster Session The 2017 NCAP Annual Convention scheduled in Winston-Salem, NC on September 22-24 will have a poster session. Presenting a poster at NCAP is an excellent opportunity to share your research with pharmacy practitioners all around the state! Selected abstracts will be published in the North Carolina Pharmacist: The Official Journal of the North Carolina Association of Pharmacists. Submissions by practitioners, students and residents are welcome! The poster session is scheduled for Saturday, September 23rd from 8:00-9:00 am with presenters to be available to discuss their research during that time.
Categories: Original Research: Clinical or educational research appealing to an audience of pharmacy professionals in North Carolina. This category may include health services, pharmacotherapy, medication safety, or patient outcomes. Abstract Headings: Objective, Methods, Results, Conclusions. Quality Improvement Evaluations: Assessments of quality improvement measures such as medication use evaluations or process improvements. This category may include ideas and practices new to a health system or practice setting. Abstract Headings: Objective, Methods, Results, Conclusions. Case Report or Series: Description of a unique patient case or series. This category may include novel indication, dose or administration of a medication. Abstract Headings: Introduction, Case(s), Discussion.
Word Count: 300 words (excluding author names and titles) Abstracts describing ongoing research will be considered with partially completed data. Descriptions of planned research without any data will not be accepted. Abstracts will be evaluated based on readability and organization, relevance, and potential impact to pharmacy practice. Please submit your name, your credentials, and your abstract to Dr. Irene Park, NCAP Convention Project Team Member, Irene.park@mahec. net. Deadline: July 15, 2017. Status of submissions will be communicated to authors by August 10, 2017. Abstracts will be printed as submitted in the North Carolina Pharmacist: The Official Journal of the North Carolina Association of Pharmacists. Edits to abstracts cannot be made after submission.
Example of a structured abstract: Category: Original Research Title: Evaluation of Compliance with National Guidelines for Insulin Initiation Authors: Kira Harris, PharmD, BCPS, CDE1,2, Jacqueline Olin, MS, PharmD, BCPS, CPP, CDE, FASHP, FCCP2 Institution: 1Crown Point Family Physicians, Charlotte NC; 2Wingate University School of Pharmacy, Wingate NC Objective: The primary purpose of this study was to determine compliance with the American Diabetes Association recommendation to initiate insulin 15
in patients with an A1c≥10% at an outpatient family medicine clinic in 2014. Secondary objectives were to determine if initiation of insulin within 3 weeks of an A1c ≥ 10% increased the rate or decreased the time to achieve an A1c<7%, and to determine if pharmacist involvement increased the rate of reaching an A1c<7%. Methods: The medical records of 121 patients with type 2 diabetes mellitus (T2DM) and an A1c≥10% from January 1, 2014 to December 31, 2014 were reviewed. Patients already receiving insulin or those without a follow-up A1c were excluded. Data collected included patient demographics, duration of diabetes, baseline and follow-up diabetes medications, baseline and follow-up A1c values, as well as pharmacy referrals. Results: Fifty-five patients with a mean age of 55 years, a mean duration of diabetes of 6.4 years, and a mean baseline A1c of 11.7% were included. Most patients were receiving no therapy (29%), monotherapy (27%) or dual therapy (29%) at baseline.
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Insulin was initiated in 5 patients (9.1%, p<0.05) within 3 weeks of the qualifying A1c. Another 5 patients (p<0.05) received insulin at some point during the study. An A1c<7% was achieved in 35.6% of patients not receiving insulin, 20% of patients receiving immediate insulin, and no patients who received insulin after 3 weeks. The mean time to A1c<7% was 6 months for patients not on insulin and 3 months for those receiving immediate insulin. Thirty-three percent of patients who met with a pharmacist reached an A1c<7% compared to 30% of patients who did not. Conclusion: Adherence with insulin initiation guidelines and rate of achieving A1c<7% in patients with A1c≥10% is low and increasing pharmacy involvement may increase the rate of reaching goal A1c.
Call For Roundtable Facilitators NCAP Annual Convention to Hold “Speak Out. Stand Out. Break Out.” Best Practices In keeping with the 2017 Annual Convention theme, Transform Through Innovation, there will be a session dedicated to discussions on innovative best practices from around the great state of North Carolina. Attendees will have the opportunity to participate in up to four roundtable discussions, lasting 20 minutes each. We are looking for practitioners who engage in innovative practices to share their experiences as they facilitate an interactive small group discussion. If you are interested in facilitating one of these discussions, please send your name, your credentials, and a brief overview (no more than 200 words) describing your innovative work. Your overview should include 1-2 objectives. The roundtable session is scheduled for Saturday, September 23rd from 1:30 – 3:00 pm. Please send your overview and learning objectives
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Precepting/Experiential
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Educating Providers About Guidelines
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Transitions of Care at Mission Hospital
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Public Health
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CPP Credentialing in Ambulatory Care
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The Clinical Training Center: A Layered-
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Tackling the Opioid Epidemic in Western NC
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Innovative Pharmacy Topics
Learning Rotation Model
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BPS Certification for Pharmacists
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It’s a Team Effort: Integrating Community Pharmacists Into Team-Based Care
to Dr. Courtney Bradley, NCAP Education Committee Co-Chair, cbradley@highpoint.edu by June 2nd, 2017. Example topics that were presented at last year’s convention include the following: -
AmCare Tool Kit
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Community Pharmacy & Physician Collab-
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Pharmacogenomics Testing in Community
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Community Value Added
orative Practice Relationships
Pharmacy
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Chronic Care Forum Update and Awards
Chronic Care Practice Forum Update Keely Ray, Past Chair, Chronic Care Practice Forum On March 15th, 2017, the Chronic Care Practice Forum (CCPF) kicked off their Annual Meeting at the Joseph S. Koury Convention Center in Greensboro, NC. The three-day event consisted of 15 hours of ACPE-accredited continuing education and provided attendees the opportunity to network with colleagues and exhibitors. Attendance at the Forum included 96 pharmacists, 12 students, 2 residents, as well as 1 out-of-state pharmacist. Program planning for next year’s meeting is already underway. During this year’s meeting, the CCPF recognized two pharmacists for their outstanding work in chronic care pharmacy. The NCAP Chronic Care Pharmacist of the Year Award recognizes a pharmacist who demonstrates an advancement of chronic care for patients and/or pharmacists or other practitioners over the past year or longer. This year’s recipient of the award is Rhonda Gentry. Rhonda has been a pharmacist for the past 29 years. She received her BS in pharmacy from University of Oklahoma in Oklahoma City, Oklahoma in 1988. She has been involved in chronic care for over 20 years, holds her BCGP, and has been a mentor for countless students and colleagues, including myself. She currently practices as a consultant pharmacist for Neil Medical Group. It is in the capacity as CCPF’s Chair and Past Chair, Rhonda served and provided direction and counsel.
Rhonda Gentry
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At the outset of her term, she set the tone as a catalyst for advancing our Forum, long-term care pharmacy practice, and the profession as a whole. While serving on the NCAP Board of Directors, she persisted in her quest for enhanced transparency regarding Board functions and Forum insight on key issues including, but not limited to, the organization’s financial status, forum-directed budgeting, and clarification of Board member roles and responsibilities. She was instrumental in spearheading the initiative for our forum to establish its very own mission and vision statements. Her leadership and contributions undoubtedly will serve as part of the foundation for our Forum’s lasting legacy, and her advocacy for improved geriatric care in our profession can also be evidenced by her involvement with ASCP. In addition to this role and continued service to our organization and members, Rhonda is also active in her community and has served as Sustaining Advisor to the Board of Directors for the Junior League of Asheville.
The Dale Jones Memorial Award for Excellence in Geriatrics is presented to a pharmacist who embodies commitment in the following areas: geriatrics & patient care, education and continuous professional development, a commitment to community, and commitment to the pharmacy profession, as we honor the late Dr. Dale Jones and his exemplary contributions to geriatrics and his compassion for always putting his patients first. This year’s recipient of the Excellence in Geriatrics Award, Lori Edwards, has been a pharmacist for 23 years. Lori received her Bachelor of Science in Pharmacy from UNC Chapel Hill in 1994 and went on to earn her PharmD in 1999 from the University of South Carolina School of Pharmacy. She completed an Advanced Clinical Clerkship at Moses Cone Hospital which involved developing a disease management protocol for pharmacists to provide cogniLori Edwards tive services for diabetes and hypertension in either an outpatient hospital practice or a physician’s office. Lori began her work as a consultant pharmacist in 1995 and continues to practice in that capacity for Neil Medical Group. In February 2006, she became a Clinical Pharmacist Practitioner with Cornerstone Healthcare. There she worked as an adjunct staff clinical pharmacist at Carolina Cardiology at Cornerstone and was instrumental in developing an anticoagulation monitoring program, providing medication management services, obesity counseling and dietary guidance for physician-ordered weight loss programs, and collaborated with other members of the healthcare team in maximizing patient outcomes. In addition to her clinical work at Cornerstone and her consultant pharmacist work in LTC, our recipient is a preceptor and adjunct clinical professor for three schools of pharmacy: UNC, Wingate, and Highpoint University. She has been an active member of NCAP and has served the past 3 years on the Chronic Care Executive Committee. She has also been a member of ASCP for many years and has been an advocate for geriatric care in pharmacy. In addition to her continued service to the organization and the profession, she is active in her community and her church. The CCPF would like to congratulate this year’s award recipients for their dedication and commitment to the profession and thank all of the attendees, exhibitors, and sponsors of the Annual Meeting. Lastly, if you or someone you know is interested in being actively involved with the CCPF, please email David Phillips, Chair (dphillips@blueridgerx.com).
Selected Powerpoint Presentations for NCAP members who were unable to attend:
1. Could I be Liable? Jay Campbell 2. Transitions in Care: What’s Your Role? Irene Park 3. Opioid Misuse and Addiction Treatment in Older Adults. Micah Sobota 4. Taking a “Break!” Bisphosphonate Holidays. Mollie Ashe Scott 5. Passing the Torch: The Emerging Role of Novel Pharmacotherapy in the Treatment of Systolic Heart Failure. Robert Tunney 19
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From the New Practitioner Network
Member Spotlight!
Holly E. Causey, PharmD, BCACP, CPP, CDE Clinical Pharmacist in Ambulatory Care Duke Outpatient Clinic, Duke University Hospital, Durham, NC Holly Causey is a graduate of the University of North Carolina Eshelman School of Pharmacy. She completed her PGY1 Community Pharmacy residency with Campbell University College of Pharmacy & Health Sciences (Buies Creek, NC) and Kerr Drug (FuquayVarina, NC). She then completed a PGY2 Ambulatory Care Specialty Residency at Duke University Hospital in Durham, NC. Following completion of her PGY2 residency, she took a position at the Duke Outpatient Clinic. She has had the privilege of implementing
a Transitions of Care service and a group hypertension visit in her clinic as well as managing patients for pain, anticoagulation, diabetes, hypertension, and general medication management. Most recently, she has implemented a protocol for the treatment of Hepatitis C Virus within her patient population. She is a clinical pharmacist practitioner (CPP), board certified ambulatory care pharmacist (BCACP), and certified diabetes educator (CDE). She is also an adjunct assistant professor at the UNC Eshelman School of Pharmacy where she teaches in the ambulatory care elective as well as precepts 4th year students on rotation. She also serves as program coordinator for the Duke University Hospital 2nd year ambulatory care pharmacy residency program. She is currently serving as chair of the North Carolina Association of Pharmacists (NCAP) Residency Committee. She has also served as chair of the NCAP New Practitioner Network Executive Committee and has served on the executive committee since 2010. Dr. Causey is also a member of the American Society of Health System Pharmacists (ASHP) Section of Ambulatory Care Practitioners’ (SACP), currently serving on the Advisory Group on Compensation and Practice Sustainability. She has previously served on Medication Therapy Management in the Community Section Advisory Group and the Pain Management and Palliative
Care Section Advisory Group and was an ASHP New Practitioner Forum Executive Committee member in 2012-2013. She has been a member of the American Pharmacist Association (APhA) since a student in pharmacy school and has served on the New Practitioner Network Transitions Advisory Editorial Board and diabetes special interest group. Dr. Causey first became involved with NCAP as a student and has remained a very active member. “NCAP allows me to stay connected. I’m able to keep up with the initiatives and legislative updates as well as socially connect with other pharmacist practitioners. On a more personal level, many of the preceptors I had as a student and resident are highly involved with NCAP. Thus, this is a way of giving back to the profession.” Her piece of advice to new practitioners: “Smooth seas do not make for skillful sailors.” My advice is simply this: respect the obstacles and adversity that come your way for they will make you a more resilient person and pharmacist practitioner.
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NCAP NEW PRACTITIONER NETWORK SPOTLIGHT Call for Nominations: The New Practitioner Network (NPN) welcomes nominations of NPN members to be highlighted in a New Member Spotlight. A nomination may be made by any NCAP member. Nominations for the Journal quarterly issues are due as follows — Winter: December 1; Spring: March 1; Summer: June 1, and Fall: September 1. Please send the NPN Spotlight Nomination Form to Olivia Bentley, NPN Chair, olivia@rxclinicpharmacy.com
NOMINATION FORM Full Name of Nominee: __________________________________________________________________ Employer: ____________________________________________________________________________ College/School of Pharmacy: _____________________________________________________________ Graduation Year: ________________ Degrees/Certifications: __________________________________ _____________________________________________________________________________________ Residency Program(s) if applicable: ________________________________________________________ _____________________________________________________________________________________ I understand that the nominee must: ·
Be an NCAP Member, and
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Have received an entry degree in pharmacy less than 5 years ago
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Licensed to practice pharmacy in NC
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Actively practices community, institutional, ambulatory care, managed care and /or consulting pharmacy
My name: ____________________________________________________________________________ Email: ________________________________________________ Phone: ________________________ Comments In Support of Nominee
Attach additional pages as needed. Provide specific information related to the spotlight criteria that will be of great help to the NPN Executive Committee. Suggestions: discuss the candidate’s current work environment, significant projects, innovations, accomplishments, current involvement in national, state or regional organizations, and community service. 22
The Importance of MTM in My Practice Brianna Luft
When I was a student pharmacist, I had the opportunity to particiåpate in a pharmacist-run MTM clinic, as an insurance company established a contract with my preceptor. Every week, I called patients and conducted Targeted Medication Reviews (TMRs) and Conducted Medication Reviews (CMRs). It was an incredible experience as I got to see first-hand how much pharmacists can influence patient care. When I graduated, I was so excited to continue these encounters that I loved so much as a student pharmacist in my new position. I am a community pharmacist, so I get to see and interact with my patients all the time. This is a perfect environment for clinical interactions with patients! However, one of the challenges I immediately faced was how to incorporate MTM into my workflow. You may be facing this same challenge as well. I use two MTM platforms, Outcomes and Mirixa, so at times it can feel a little overwhelming with so many tasks to complete. The biggest issue I found was how to accomplish both what I want to do and what I need to do. But, in my short time as a pharmacist, I’ve
started to make it work. It has a taken a few months of trial and error, but here are some of the tips I found that help me: Make MTM a priority. Every morning I log into Outcomes and Mirixa, and I see what opportunities await me. I print these out and keep them next to me all day so that I’m thinking about them. Try to catch patients in the store. Sometimes you don’t have time to reach out to the patient via phone call, but you can ask them questions when they’re picking up their medications. I’ve also found that sometimes they are more willing to participate in person! Preparation is key. For my very first MTM call, I didn’t have everything I needed ready to go, and the call took longer that I had hoped and didn’t go very smoothly. One thing I like to do is fill in the patient’s mediation list from their profile,
so that all I have to do is confirm medications, rather than populate them during the encounter. Have a good grasp on what MTM is and be able to explain in. When I call a patient, I ask if they would like to participate in a “free medication review” and I make sure to emphasize that it can be completed over the phone in about 10 – 15 minutes. When I ask in this way, they understand what I am trying to accomplish with the call, and they are aware of what I expect of them. I don’t get to provide these clinical services every day, but I feel much more enriched and connected to my patients on the days where I do get to complete them. Despite initial challenges with balancing it all, I am happy that I have found a way to help my patients stay educated about their medication regimens and help them in any way I can! Brianna Luft, PharmD, is a staff pharmacist at Rite Aid in High Point, NC. 23
Selecting a Residency Project That is Congruent with Your Career Interests
Tony Rudisill, PharmD, MBA, Dick Cason, MS, RPh, Regina L. Ramirez, PharmD, BCPS
A Brief Summary Optimization of Automated Dispensing Cabinets to Improve Utilization and Improve Efficiency of Dispensing Workflow at an Academic Medical Center Tony Rudisill, PharmD, MBA Dick Cason, MS, RPh Regina L. Ramirez, PharmD, BCPS As part of the requirements for an ASHP-accredited pharmacy practice residency, residents must select a longitudinal project. This experience is both exciting and frightening as the resident will be spending large amounts of time working on this task. As a pharmacy practice resident with an interest in pharmacy leadership, I was able to select a project that afforded me the opportunity to work with managers from multiple departments. My project was identified as a way to improve the medication-use process at the University of Texas Medical Branch in Galveston, Texas. Introduction Pharmacy in health systems aims to make the medication-use process more efficient by decreasing the time between a medication order and the administration of that medication. To help facilitate this goal, many hospitals have incorporated automated dispensing cabinets (ADCs) into their workflow.
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Automated dispensing cabinets serve as a valuable resource to pharmacy departments. In addition to storing and dispensing medications, the computerized software provides reports to assist in controlling and tracking medication distribution. Literature suggests storing medications in ADCs located in patient care areas reduces the risk of medication errors, minimizes medication delays, and improves patient care. It is important for patients to receive their medications in a timely manner because medication delays have been linked to both negative health outcomes and potential delays in transfers and patient discharges.1 Automated dispensing cabinets allow emergent medications, as well as frequently used medications, to be securely stored closer to patients, making them more accessible to nurses when it is time for administration. Approximately 90% of the hospitals in the United States use ADCs, and nearly 70% of all hospitals use ADCs as the primary means for medication dispensing.1,2 The process of preparing and delivering individual orders can cause delays in the medication-use process and medication administration. Delays in medication administration are concerning and lead to patient dissatisfaction and increased numbers of medication re-dispenses from the nursing staff. Better utilization of the ADCs correlate with reduced time between pharmacist order verification
and patient medication administration.1,3 Project Rationale The University of Texas Medical Branch (UTMB Health) is an academic medical center located in Galveston, Texas. The average census is about 481 patients, and UTMB Health utilizes a combination of ADCs, manual deliverers, and cartfills for medication distribution. There are a total of 74 Pyxis Medstations® located throughout the medical center. Prior to this optimization project in 2016, despite having ADCs in most patient care areas, only 45% of all medication doses were dispensed from ADCs. Delays in medication delivery are reported by nursing to the Patient Safety Net (PSN) reporting system. These reports are frequently monitored for impact on patient outcomes. In addition to reporting delays through PSN, nurses send messages directly to the pharmacy requesting the patient’s medications. Once the message has been read, a pharmacist will often re-dispense the needed medication, unless he or she is certain the medication has recently been delivered. Better availability of medications in the ADCs should reduce the number of reported delivery delays, inbasket messages, and medication re-dispenses. Therefore, putting more of the appropriate medications in ADCs is believed to increase nurse satis-
faction while decreasing PSNs, unnecessary inbasket messages, and re-dispenses. Project Methods The need to optimize ADC utilization was supported by hospital leadership as well as pharmacy managers. Early in my residency year (2016-2017), the opportunity to be part of the optimization project was presented to me. From the start, it was apparent my interventions through this project would have a positive impact throughout the entire hospital. My study focused on ADC use and the overall cabinet utilization in ten selected patient care units located in the new Jennie Sealy Hospital. The units were selected based on multiple criteria including pre-optimization utilization rate, total dispenses to each unit, and nurse manager requests. The patient care units where the interventions took place were all adult populations which included: adult medicine, cardiology, surgical/ trauma intensive care unit, geriatric, oncology, transplant, and general surgery. The project consisted of three periods over six months. Each period was two months in duration and identified as: pre-optimization, intervention, and post-optimization. The pre-optimization period took place in September and October was strictly a data collection period. During the next two-month period, November and December, all interventions for the ADC optimization project occurred. During this period, medication inventory was modified within each ADC in order to provide those medications used most frequently on that patient care unit. The final phase, labeled post-optimization, was another data collection period during January and February. To
better assess the impact of the optimization project, no adjustments were made to the ADC inventory during the pre- and post-optimization periods, which were strictly data collection periods. The primary endpoint was to measure ADC utilization within ten selected patient care units, as described above. In addition, secondary endpoints evaluated the number of Patient Safety Net (PSN) reports, inbasket messages, as well as medication re-dispenses. Automated dispensing cabinet utilization rate was defined as the total number of medications dispensed within a patient care unit from an ADC divided by the total number of medications dispensed to that unit from all dispensing locations. The optimization process evaluated the appropriateness of the medications placed in each cabinet. The intended outcome was to support the proposal that adding frequently used medications to ADCs, in conjunction with par (pick-and-replenish) level adjustments, reduces the time to medication administration and unnecessary workload for the pharmacy team. Par level adjustments were made to help reduce the number of reported stockouts by setting 3-day minimum medications supplies, and five- to sevenday maximum supplies if space permitted. Results Prior to 2016, it is unknown when the last time an ADC assessment had taken place. Despite an institution-wide pre-optimization ADC utilization rate of 45%, a closer look at the ten selected patient care units revealed a much lower ADC utilization rate. Postoptimization analysis revealed an increase in utilization rates for all
of the ADCs selected. Overall, the average utilization rate increased from 31% pre-optimization to 53% post-optimization in the study patient-care units. Other endpoints analyzed included inbasket messages, re-dispenses, and PSNs reported. The analysis of these endpoints revealed that there were no correlations between ADC utilization and any of the secondary endpoints. Inbasket messages increased in some units and decreased in others, leading to a total decrease of 7%. The hypothesis was that if inbasket messages decrease, so would re-dispenses. The opposite was actually observed and total re-dispenses increased 6%. The total number of PSNs reported also increased from six during pre-optimization to sixteen post-optimization. Project Limitations There were several limitations to the project that should be considered. During the post-optimization data collection period, the hospital had to relocate patients from the old John Sealy Hospital to the Jennie Sealy Hospital where the ten intervention units were located. Relocated units included: the burn unit, the neonatal intensive care unit, the cardiac catheterization lab, and post-partum mothers and babies, to name a few. The relocation was unexpected and may help explain why the secondary outcomes did not correlate with increased ADC utilization. For example, the post-partum mothers and babies unit was relocated to a geriatric unit in January where ADC optimization had already occurred. Due to the timing of the relocation, no changes could be made to the ADC inventory; therefore, medications in the ADC were 25
more appropriate for the geriatric population. Several other units were affected by patient relocations, but not as significantly as the unit previously mentioned. Another limitation is education regarding the changes that occurred in the ADCs. Unit-specific handouts were created and posted to show medications that were added to each of the ADCs. I personally met with pharmacy and nurse managers to discuss ADC changes. Despite the communication efforts, there were still reports that some employees were not aware of the changes that had occurred. Project Conclusion Since the post-optimization period, I have had the opportunity to meet with pharmacy and nurse managers to discuss the changes supported by this project. The intervention has been well received, and pharmacy staff has been able to adjust to workflow shifts. Hospital leadership recently reported to pharmacy managers that nurse satisfaction with the ADCs and pharmacy has improved. This project is being considered successful, and the department did not have to spend money on additional equipment or supplies. Going forward, in an effort to further increase ADC utilization rates, a budget request has been placed to add auxiliary cabinets for additional storage on the patient care units. It is also felt that having a staff member routinely monitor ADC stock will also help dispensing efficiency. The optimization project has helped to align a required residency project with my leadership interest. The project has allowed me to work directly with pharmacy leadership, nurse managers, as well as front-line pharmacists 26
and technicians. The project has allowed me to gain a better understanding of hospital operations and how something as simple as adding a few medications to ADCs can have major impacts on pharmacy workflow. I have also gained a new appreciation for working on a longitudinal project, as this was the first time I was involved in a project of this magnitude. Overall, I have greatly enjoyed the project, and I know that going forward I will be able to apply the experiences gained through this project to other projects that will present in the future. My advice for future residents selecting projects would be to select a project that is within your interest area. You will be dedicating a great deal of time to this project, and it is something that you should enjoy. Do not be afraid to ask many questions initially and be a bit skeptical about whether the project will have significant contributions. Initially, I started with a different project relating to patient care in our emergency department. However, after several brainstorming sessions with the principal investigator and other clinical staff, it was determined that the project was not appropriate. Completing the project as described above actually worked out better because I know that my project will have great contributions to the hospital for years to come. Tony Rudisill, PharmD, MBA, a 2016 graduate of Wingate University School of Pharmacy, is a Pharmacy Practice Resident at The University of Texas Medical Branch in Galveston, Texas. Dick Cason, MS, RPh, is the Administrative Director of Pharmacy, The University of Texas Medical Branch in Galveston, Texas.
Regina L. Ramirez, PharmD, BCPS, is the PGY1 Pharmacy Residency Program Director and Clinical Practice Specialist – Solid Organ Transplant and VAD Programs, The University of Texas Medical Branch in Galveston, Texas. References: (1) Pedersen CA, Schneider PJ, Scheckelhoff DJ. ASHP national survey of pharmacy practice in hospital settings: dispensing and administration—2011. Am J Health Syst Pharm 2012;69(9):768–85. doi: 10.2146/ajhp110735. (2) State of Pharmacy Automation. August 2015. Pharmacy Purchasing and Products. Vol 12(8): 72-76 (3) O’Neil DP, Miller, A., et al. A comparison of automated cabinet methods. Am J Health System Pharm 2016; 73:e400-e405. doi:10.2146/ajhp150423
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Education and Practice Patient Safety Organizations – 2017 Update
John M. Kessler
Community pharmacy is doing much better in its patient safety efforts these days as evidenced by the new deployment of patient safety evaluation systems in large numbers of pharmacies. Since 2008, more than 8,000 community pharmacies have voluntarily implemented systems to identify risks, report errors and near-misses, learn from these events and implement corrective actions to reduce the burden of harm1. In addition, these pharmacies are sharing their event data within Patient Safety Organizations (PSOs) to help one another learn. This sharing has not always been the case. Community pharmacy does not have a long history of systematically learning from mistakes nor effectively identifying and reducing risks. This contrast begs the question: why have so many community pharmacies improved their safety efforts? The pivotal Institute of Medicine report in 20002 identified that errors and adverse events were largely unreported due to a national culture of fear, blame, and litigation. The IOM report concluded that errors and harm will repeat unless they are reported, investigated, analyzed, shared with others, and acted upon. A major recommendation was that: Congress should pass legislation to extend peer review protections to data related to patient safety and quality improvement that 28
are collected and analyzed by health care organizations for internal use or shared with others solely for purposes of improving safety and quality. This recommendation set the stage for the federal Patient Safety and Quality Improvement Act (the “Act”) of 2005 and the formation of Patient Safety Organizations (PSOs), whose role is to provide a confidential and protected framework for reporting, analyzing, and sharing reports of errors, adverse events, close-calls, unsafe conditions, root cause analyses, and other quality improvement-related information. Detailed information about PSOs can be found here: https://www.pso.ahrq.gov/ For the first time ever, pharmacies that are not part of hospital systems or other peer review programs can now benefit from statutory protections, but only if they voluntarily joined a PSO. As of March 29, 2017 there are 86 PSOs in existence (https:// www.pso.ahrq.gov/listed/). Eight PSOs self-identify pharmacy as a specialty, and three list retail pharmacy as the type of facility served. Table 1 lists the PSOs located in North Carolina; two serve the Carolinas HealthCare System, and one serves primarily hospitals and related facilities. Table 2 shows those PSOs that specifically list retail pharmacy as the type of facility served. Pharmacies can join one or more PSOs regardless of where the PSO is located.
Table 1. PSOs Located in North Carolina* Carolinas HealthCare System Patient Safety Organization Carolinas Rehabilitation Patient Safety Organization NC Quality Center PSO (NC Hospital Association) Table 2. PSOs Listing Retail Pharmacy as the Type of Facility Served* Alliance for Patient Medication Safety (serves all states) The PSO Advisory, LLC (serves all states) The Patient Safety Research Foundation, Inc. (serves Walgreens Pharmacy) *For up-to-date contact information to all PSOs see: https:// www.pso.ahrq.gov/listed. Tables 1 and 2 are based on voluntarily reported profiles from each PSO. What is the PSO mission? PSO mission statements vary, yet they share two common themes – 1) to achieve the highest levels of quality and safety, and 2) to protect patient safety work product from discovery.
What are the quality and safety benefits of joining a PSO?
What are the legal benefits of joining a PSO?
In addition to providing safety training, education, consultations, and toolkits, PSOs work with their members to develop robust safety structures and processes – in brief, a patient safety evaluation system. PSOs help their members identify and recognize the hidden-risks in their workflow. As one example, design flaws in the pharmacy workflow (both clinical judgment and technical dispensing activities) can lead employees to take short-cuts or create work-arounds that can allow a dangerous prescription to reach the patient. These behaviors can readily become “normalized” practice, desensitizing employees from the risks and off-setting the protections of normal safety checks. In brief, safe practices drift into unsafe habits, and situational awareness declines. From a clinical perspective, these practices include failing to manage allergy information, drug interaction alerts, high-dose alerts, and effective communication with their patients. PSOs also aggregate and analyze data from their members, increasing the odds of detecting trends not readily visible in individual pharmacies. Pharmacies identify and report qualityrelated events to the PSO; all with the goal of identifying risks in the system to develop new learnings. Pharmacies can also benefit when they engage their PSO to conduct “deep dives” into their data for comparative analyses.
Collected and reported quality and patient safety data are shielded by federal confidentiality and privilege protections. This means that when you adhere to the Patient Safety Rules, you cannot be forced to disclose information identified as Patient Safety Work Product (PSWP) in criminal, civil, administrative, or disciplinary proceedings. PWSP includes event reports, Root Cause/Systems Analyses, minutes of quality and safety meetings, analytical/trend reports, communications to/from the PSO, and related information listed in the Act. Your PSO will assist you in designing your Patient Safety Evaluation System (PSES) to maximize these protections. Your PSES is your “protected workspace” and is the system of procedures and policies for collecting, managing, and analyzing information for reporting to a PSO. What are the responsibilities of pharmacies that join a PSO? To maximize the legal protections afforded by the Act, pharmacies must enter into a contractual agreement to join a PSO, develop and maintain a PSES, conduct all quality and safety activities within the PSES, maintain PSWP as confidential and protect PSWP from disclosure outside the PSES. PSOs, with their members, must conduct the patient safety activities listed in Table 3.
Table 3. Patient Safety Activities 1. Efforts to improve patient safety and the quality of health care delivery 2. The collection and analysis of patient safety work product (PSWP) 3. The development and dissemination of information regarding patient safety, such as recommendations, protocols, or information regarding best practices 4. The utilization of PSWP for the purposes of encouraging a culture of safety as well as providing feedback and assistance to effectively minimize patient risk 5. The maintenance of procedures to preserve confidentiality with respect to PSWP 6. The provision of appropriate security measures with respect to PSWP 7. The utilization of qualified staff 8. Activities related to the operation of a patient safety evaluation system and to the provision of feedback to participants in a patient safety evaluation system Have PSOs been effective in accomplishing their mission? Quality and safety mission PSOs have increased the adoption of best practices related to reporting, analyzing and acting upon quality-related events. They routinely publish recommendations to improve the workflow and safety culture. 29
They provide expertise, education, and tools to facilitate the conduct of thorough and credible root cause/system analyses. As one example, the Alliance for Patient Medication Safety, a community pharmacy PSO, has assisted several thousands of community pharmacies implement a continuous quality improvement program with standardized reporting software and analytical tools for use within a PSES. Its program includes educational and consultative services designed to strengthen the pharmacy’s response to all types of quality-related events, while also teaching how to prevent future events from causing harm. Legal protection mission PSOs have been successful in preventing release of confidential and protected information when courts, regulatory agencies, and others have requested disclosure of the PSWP. In one of the earliest legal challenges to the protection and privileges of the Act, Walgreens Pharmacy successfully argued in a 2010 trial court case that its quality-related event reports were PSWP and not subject to legal discovery. Furthermore, the 2010 court decision was unanimously upheld by an appeals court review in Illinois in 2012. Most importantly, however, these protections can be realized only when the pharmacy adheres to the nuanced and increasingly complex interpretations of the Patient Safety Rule. Your PSO helps assure you are compliant. The Alliance for Quality Improvement and Patient Safety 30
(AQIPS) supports its member PSOs with legal counsel and education. AQIPS also tracks key court cases. Of local interest in North Carolina, a settlement agreement was reached and the complaint was dismissed without the facility having to disclose PSWP. AQIPS served as an expert witness on whether the PSES was designed properly and how the PSWP was created. Is my pharmacy required to join a PSO? There is no legal requirement to join a PSO. It’s a voluntary decision; however, your pharmacy must be a contractual member of a PSO and comply with the Patient Safety Rule to enjoy the legal protections and derive the clinical benefits. Should my pharmacy join a PSO? It’s a difficult decision to “go it alone” in patient safety and quality assurance. As noted in this brief review, PSOs can provide federal legal protections, but only to their members. PSOs also directly connect busy pharmacies to safety expertise and resources that might otherwise be less readily available. 1. Personal communication, Tara Modisett, Executive Director for the Alliance for Patient Medication Safety PSO, April 26, 2017. 2. To Err Is Human: Building a Safer Health System. Linda T. Kohn, Janet M. Corrigan, and Molla S. Donaldson, Editors; Committee on Quality of Health Care in America, Institute of
Medicine. 2001 https://www.nap.edu/search/?ter m=to+err+is+human&x=0&y=0
John M. Kessler, B.S. Pharm., PharmD Chief Clinical Officer SecondStory Health, LLC jkessler@secondstoryhealth. com Disclosures: Dr. Kessler is a collaborator with various PSO’s and AQIPS. He is the medication safety expert for the Alliance for Patient Medication Safety.
BPS CONTACT Ernest Wright ewright@aphanet.org 202-429-7510 www.bpsweb.org
Board of Pharmacy Specialties Announces New Specialties in Cardiology and Infectious Diseases
Washington, D.C. – The Board of Pharmacy Specialties (BPS) is pleased to announce the approval of two new specialties; cardiology pharmacy and infectious diseases pharmacy. This announcement follows the final review of the petitions for each new specialty that took place during the BPS Board meeting held on February 8, 2017. Harold Godwin, the 2017 Chairman of the BPS Board of Directors and Professor Emeritus at the University of Kansas School of Pharmacy provided the following comments: “The Board of Pharmacy Specialties is very pleased to formally acknowledge two new pharmacy specialties. The recognition of these specialties further illustrates our growth as a clinical profession and our ever increasing responsibilities in providing patient care. I want to also acknowledge the collaborative efforts of the four national pharmacy associations that developed these petitions. That type of collaboration is critical to the continued success of the pharmacy profession.” Cardiology Pharmacy Cardiology pharmacy becomes the tenth BPS specialty. The petition was submitted jointly by the American College of Clinical Pharmacy, American Pharmacists Association and the American Society of Health-System Pharmacists. The petitioning organizations have defined Cardiology Pharmacy practice as follows: Cardiology Pharmacy practice specializes in the delivery of direct patient care services by pharmacists as members of interprofessional healthcare teams, working to ensure the safe and effective use of medications in patients with cardiovascular disease. These specialists focus on disease prevention and treatment, including evidence-based medication use and related care that improve both short- and longterm outcomes for patients. Cardiology specialists practice across the spectrum of care, including ambulatory, acute and intensive care. Pharmacists in this practice review, analyze and monitor multifaceted clinical information to make reasoned decisions for patients with multiple comorbidities and highly complex mediation regimens. Infectious Diseases Pharmacy Infectious diseases pharmacy becomes the eleventh BPS specialty. The petition was submitted jointly by the American College of Clinical Pharmacy, American Pharmacists Association, American Society of Health-System Pharmacists and the Society of Infectious Diseases Pharmacists. The petitioning organizations have defined Infectious Diseases Pharmacy practice as follows: Infectious Diseases Pharmacy practice specializes in the use of microbiology and pharmacology to develop, implement, and monitor drug regimens that incorporate the pharmacodynamics and pharmacokinetics of antimicrobials to optimize therapy for patients. The practice requires pharmacists to use clinical and evidence-driven knowledge to develop appropriate antimicrobial therapies to more rapidly resolve infections while decreasing adverse events, complications and resistance. The practice includes direct patient care provided through interprofessional health care teams, collaborative leadership of antimicrobial stewardship programs, education of health care providers, preventive services including immunizations, and advocacy for appropriate antimicrobial utilization. Specialty pharmacy practice in infectious diseases uniquely improves public health by optimizing antimicrobial potential in individual patients and narrowing the resistance trends that occur in society by preventing progression of antimicrobial resistance and infectious diseases.
Next Steps The next steps in the specialty certification process are outlined below: •BPS will issue a call during the first week of March 2017 for nominations to serve on the Cardiology and Infectious Diseases Pharmacy Specialty Councils. The closing date for nominations will be May 1, 2017. • BPS will appoint nine members to each Council by June 2, 2017. •The Councils will convene, on dates to be determined, in July 2017. •Examination item writing for the new specialties will begin during the third quarter of 2017 with a goal of offering the first examination in September 2018. Added Qualifications Program The BPS Board will re-evaluate the current Added Qualifications program. However, the Board anticipates that the Added Qualifications program for Cardiology and Infectious Diseases will end as of December 31, 2017 based upon the plan to offer the first examinations in those specialties in 2018. Individuals currently holding Added Qualifications can keep those credentials until they expire but will not be able to renew them. The National Commission for Certifying Agencies (NCCA) standards prohibit BPS from conferring Board Certification to those who hold Added Qualifications in either Cardiology or Infectious Diseases without passing the respective certification examination. William Ellis, BPS Executive Director added, “The growth of BPS and the addition of new specialties reflects the growth and maturation of the pharmacy profession. BPS is committed to being responsive and flexible in evaluating possible specialties that will improve patient care through recognition and promotion of specialized training, knowledge, and skills in pharmacy through the specialty board certification of pharmacists.” Eleven specialties are currently recognized by BPS including: (1) Nuclear Pharmacy, since 1978; (2) Nutrition Support Pharmacy, since 1988; (3) Pharmacotherapy, since 1988; (4) Psychiatric Pharmacy, since 1992; (5) Oncology Pharmacy, since 1996; (6) Ambulatory Care Pharmacy, since 2009; (7) Critical Care Pharmacy, since 2013; (8) Pediatric Pharmacy, since 2013; (9) Geriatric Pharmacy in 2017 (through CCGP); (10) Cardiology Pharmacy in 2017; and (11) Infectious Diseases Pharmacy in 2017. BPS certification exams are administered at over 500 locations worldwide, the Spring testing window application deadline is March 6, 2017 and the Fall 2017 registration will be open from May 8, 2017 until August 1, 2017. Candidates can register by going to the BPS website at www.bpsweb.org. About the Board of Pharmacy Specialties The Board of Pharmacy Specialties (BPS) was established in 1976 as an autonomous division of the American Pharmacists Association (APhA). The mission of the Board of Pharmacy Specialties is to improve patient care and increase awareness of the need for BPS Board Certified Pharmacists as integral members of multidisciplinary healthcare teams through recognition and promotion of specialized training, knowledge, and skills in pharmacy and specialty board certification and recertification of pharmacists throughout the world. Board Certification through BPS has become recognized as the gold standard for determining which pharmacists are qualified to contribute at advanced practice levels as a result of the rigorous standards mandated by BPS board certification and recertification. Today over 30,000 pharmacists worldwide hold BPS certification. 31
Research Update and Precision Dosing Survey Opportunity 1. NCAP is interested in the ongoing Comprehensive Medication Management (CMM) project being led by investigators at UNC and funded by ACCP. For the March 2017 quarterly update, go to: https://www.accp. com/report/index.aspx?iss=0317&art=1 2. The UNC Eshelman School of Pharmacy is undertaking a Precision Dosing Initiative. One of the first steps is to determine what, if any, information is available concerning integration of precision dosing software into the electronic medical record and how that is being used by providers. We have prepared a brief survey on this topic. The survey should take no more than 10 minutes to complete. The survey has been reviewed by the UNC Biomedical IRB, and it was determined that the survey did not constitute Human Subjects Research. Here is the link to the survey: https://unc.az1.qualtrics.com SE/?SID=SV_9tMm4AphJGglsKp
Prescribing Patterns of Statin Therapy Compared to American Diabetes Association Standards of Care at an Academic Internal Medicine Center Adam Corey, Jennifer J. Kim Abstract Objective: This study aims to describe the adherence to guidelines published by the American Diabetes Association with regard to statin therapy in lipid-lowering treatment. Per 2016 recommendations, all patients with diabetes mellitus between the ages of 40 and 75 should be on statin therapy, if tolerated. This guideline includes patients with atherosclerotic cardiovascular comorbidities and at least one risk factor who are candidates for therapy with a high-intensity statin. 32
Methods: This retrospective, descriptive study analyzed all patients age 40-75 years and diagnosed with diabetes mellitus with a documented clinic encounter between January 1, 2015 through August 15, 2016. Patients were excluded if they did not have a documented primary care physician at the time of data collection. Data collected included current medications, medical conditions, height, weight, LDL, and history of statin use. Results: Six hundred twenty-nine patients were included in the study. The majority of patients (450, 71.5%) were currently on statin therapy. Of the 179 patients (28.5%) not receiving a statin, only 12 (5.2%) had a non-statin lipid-lowering agent on profile. In addition, 65 patients (36.3%) had no stated history of statin use, 28 patients (15.6%) reported intolerance to statin, and 72 patients (40.2%) lost statin therapy after prior use. Conclusion: Based on the available data, guidelinedirected treatment is being followed in the setting of medical resident training with multiple opportunities for pharmacist-led interventions to improve statin prescribing for diabetes patients.
Introduction Heart disease remains the leading cause of death in the United States.1 For atherosclerotic cardiovascular disease (ASCVD) risk reduction, the American Diabetes Association (ADA) standards of care recommends that, with lifestyle changes, diabetes patients between the ages 40 and 75 years should be considered for statin therapy of at least moderate-intensity. High-intensity statin therapy is recommended for those with a history of prior ASCVD events (coronary artery disease, cerebrovascular accident, or peripheral artery disease) or the presence of one of more risk factors including an LDL-cholesterol ≥ 100 mg/dL, hypertension, smoking, body-mass index (BMI) ≥ 25, or family history of premature ASCVD.2 Disease-state guidelines assist clinical practitioners in determining treatment, generally based on available clinical evidence. Adherence to ADA guidelines is expected to improve clinical outcomes for diabetes patients by managing the disease and reducing morbidity and mortality. The reduction of ASCVD events and mortality favors the use of statin therapy in diabetes patients, improving patient outcomes and reducing costs. Initiation of statins depends on the prescriber to educate the patient and recommend use. The patient’s use of statins depends
on understanding the purpose and potential side effects of the drugs. Patients decline a prescription for a statin because they may not know that diabetes increases the risk of ASCVD or may express concerns regarding the associated myalgia with statin use. Patient nonadherence may also relate to the cost of agents or to statin discontinuation in the transitions of care process.
The importance of statin therapy for diabetes patients provides an opportunity for pharmacists and other providers to identify appropriate interventions to improve care. Electronic medical records (EMRs) can be used to quickly identify patients who would benefit from pharmacotherapy interventions to reduce ASCVD. This study reports on a sample of diabetes patients to identify the rate of current statin therapy and to identify the reasons for statin agents not being prescribed. Cone Health Internal Medicine Center (IMC) is a hospital-based, patient-centered medical home caring for adult patients regardless of financial status. As part of Cone Health Medical Group, the clinic serves as a teaching site for the Cone Health Internal Medicine Residency located within Moses H. Cone Memorial Hospital in Greensboro, NC. Medical staff includes 12 attending physicians, 22 resident physicians and 1 clinical pharmacist. Of 2,000 total patients, the payer mix consists of approximately 45% Medicare, 17% Medicaid, 19% commercial, and 19% uninsured. About 20% of the population receives charity care. Patients with documented diabetes make up approximately 31% of patients seen in the clinic.
A generalist clinical pharmacist is available Monday through Friday to collaborate with the interdisciplinary team to resolve medication-related problems, optimize treatment and prevention for a variety of disease states, provide patient education, participate in quality improvement initiatives, and serve as educator for Greensboro Area Health Education Center, University of North Carolina Eshelman School of Pharmacy, and Cone Health Internal Medicine Physician and Pharmacy Residency programs. Methods This study was an IRB-approved cross-sectional analysis of diabetes patients within the internal medicine clinic. All patients between 40 and 75 years old encountered in clinic between January 1, 2015, through August 15, 2016, with a documented diabetes diagnosis were included in the analysis. Patients without an identified primary care physician at the time of data collection were excluded. Descriptive statistics were used to ana-
lyze information collected from patient profiles. Patient information collected included current medical conditions, medications, height, weight, lipid panels, and history of statin use. The primary outcome was percentage of patients on statin therapy in accordance with ADA guidelines. The secondary objectives were to determine the reasons patients lack appropriate statin therapy and to describe population ASCVD risk factors. Results An electronic database search identified 629 patients who met inclusion criteria and found that 450 patients (71.5%) were currently on statin therapy (Table 1). However, 179 (28.5%) patients were not prescribed a statin medication at the time of data collection. Within one month following data collection, 9 patients (5%) had a statin added to their patient profile.
Of the 179 patients not on statin therapy, 65 (36.3%) had no history of a statin being prescribed nor any discussion of statin use in the medical chart (Table 2). Seventy-two patients (40.2%) had documentation of previous statin therapy, but the medication was removed from their profile. Only 28 (15.6%) patients without a statin had a documented intolerance. Several patients lacked any records of having a lipid panel collected despite age and diabetes status.
Of the patients not on statin therapy, 40 (22.4%) had experienced a documented ASCVD event including 11 cases of coronary artery disease, 16 strokes or transient ischemic attacks, and 13 with peripheral artery disease (Table 3). Hypertension was most prevalent in our group without statin therapy (90.5%), followed by overweight/obesity (84.4%), LDL-cholesterol ≥ 100 mg/dL (59.2%), and then smoking (25.1%). Overall, 10% of patients possessed all 4 risk factors, while 48% had 3 of the 4 risk factors. Only 2 patients not on a statin lacked ASCVD and risk factors. Discussion A thorough review of 629 clinic patients diagnosed with diabetes between the ages of 40 and 75 years found that 71.5% were currently prescribed statin therapy. This number reflects those patients with a statin on the medication profile at the time of data collection regardless of dose-intensity. Of the patients on statin therapy, 91.9% were prescribed either a moderate- or high-intensity statin. Atorvastatin 40 mg was the most prescribed agent at 20% followed by pravastatin 40 mg at
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19.3%. The ADA guidelines recommend a high-intensity statin for nearly all patients within the collected data set, unless they have no ASCVD risk factors or were unable to tolerate a higher intensity dose.2 An escalation of therapy may represent an avenue of targeted intervention for pharmacists, particularly in the 8.9% of patients taking a low-intensity statin. Out of 629 patients, 28.5% were lacking any statin therapy at the time of data collection and represent an opportunity for pharmacist-directed intervention to decrease ASCVD risk. Subsequently, 5% of the patients were started or restarted on a statin between data collection and subsequent EMR review one month later. Sixty-five patients (36.3%) had no history of any statin use within the EMR records. For many patients, no discussion of statin therapy had been mentioned in the patient notes. Several patients had no recorded lipid panel, limiting the possibility of identifying a major risk factor for ASCVD. One patient note specifically stated that she was not a candidate for statin therapy despite the presence of diabetes and three additional risk factors for ASCVD.
Many patients (40.2%) without current statin therapy had previously been prescribed a statin, but the agent no longer appeared on the medication profile. In many cases, no reason was given for the discontinuation. The medication simply disappeared. In a few instances, the patient reported “not taking” during medication reconciliation when hospitalized, leading to discontinuation at discharge with no note indicating the reason. It could not be determined if the patient stopped due to adverse events, cost or another reason. Adverse events and statin intolerance was noted in 15.6% of patients. The statin was discontinued due to elevated liver function tests or, most commonly, muscle aches. Some patients reported intolerance to multiple statins, but most stopped lipid-lowering therapy after one agent. These patients may benefit from a trial of an alternative statin or the initiation of a non-statin therapy such as ezetimibe.
Every patient included in the study had indications for statin therapy due to the presence of diabetes and age. Patients with a history of ASCVD represent one of the statin benefit groups and should receive high-intensity treatment.2 A history of ASCVD was found in 22.4% of patients without a statin. Many of these were patients previously receiving treatment, but the agent was lost for undocumented reasons. The ADA also recommends high-intensity therapy in patients with one or more ASCVD risk factors.2 Only 2 patients without current statin use met the criteria for moderate-intensity doses
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because they had no history of ASCVD nor had any risk factors. Hypertension was the most common risk factor, found in 90.5% of patients. Overweight patients made up 84.4% of the patient population. These numbers are consistent with the anticipated comorbidities of obesity, diabetes and hypertension. Only 59.2% of patients had a recent LDL-cholesterol greater than 100 mg/dL. This result could be due to several reasons. Seven patients lacked any history of lipid panels and the LDL could not be determined. Additionally, 20 patients had previously been on statin therapy before, therefore an LDL-cholesterol <100 would be due to efficacy of treatment as opposed to identification of patient baseline risk factors. Few published studies have assessed statin prescribing practices. One study reviewed primary care patients aged 40-75 years and found that 1,448 (32%) of 4,536 patients were not on statin therapy when indicated.3 Another study evaluated a national registry and found that 32.4% of 1,129,205 statin-eligible patients were not on statin therapy.4 Our study found 28.5% without statin therapy out of 629 patients, similar to the other studies cited above, identifying a potential area for pharmacists to impact care.
The pharmacist’s potential role in improving statin prescribing was recently described in one randomized trial of dyslipidemia patients in Canada. Pharmacists met with patients at an initial clinic visit followed by subsequent visits or telephone calls as necessary, occurring at 6, 12, 18, and 24 weeks post-randomization. Pharmacists ordered medications and labs and managed adverse effects as indicated. This study achieved an improvement in the proportion of patients achieving LDL-cholesterol targets by 25% (p = 0.007). Odds of achieving target LDL-cholesterol were 3.3 times higher for intervention patients (p = 0.031). The adjusted mean difference between groups of LDL-cholesterol reduction was 0.546 mmol/L, or 21 mg/dL (p < 0.001). These results indicate that pharmacists can impact care for patients requiring lipid-lowering therapy and can serve as a model for clinical pharmacist service implementation.5
The current study focused on the identification of eligible diabetes patients between the ages of 40 and 75 years. We selected diabetes patients in order to implement a targeted approach for quality improvement in our practice setting. According to the ADA, statins are recommended in all patients in our study. For patients who fall outside of this population, statins are recommended for those under 40 years with ASCVD or risk factors, and those over the age of 75 should be considered for at least moderate-intensity therapy. The ADA guidelines were chosen for practicality in our practice
setting because indications for statin therapy utilize characteristics that are readily retrievable by our EMR. Other guidelines determine the need for therapy based on risk calculators that may require more information and more time. However, risk calculators may be used in a variety of patient populations and can help to guide other cardiovascular risk reduction therapy recommendations such as aspirin initiation. Clinicians may have access to lipid panel results that include patient risk scores, and EMR platforms may evolve for feasibility of these calculations. Strategies utilized for statin prescribing will vary for each practice setting depending on resources and personnel available. Future goals of our study include implementing a pharmacist-led service for statin prescribing, increasing inter-professional education around statin prescribing, reviewing for appropriate statin intensity, improving documentation of reasons for no statin when otherwise indicated, utilizing strategies for statin intolerance such as a trial of other statins or reduced dosing, expanding to other statin benefit groups, facilitating appropriate use of non-statin agents, and supporting adherence and persistence to lipid-lowering therapy. Conclusions In an internal medicine teaching clinic, 71.5% of diabetes patients were on statin therapy. This cross-sectional analysis identified initial opportunities for improving statin prescribing for patients who may benefit from ASCVD risk reduction through targeted pharmacist interventions in the 28.5% of patients not receiving statin therapy. References 1. Centers for Disease Control and Prevention. Leading causes of death. National Center for Healthcare Statistics. http://www.cdc.gov/nchs/ fastats/leading-causes-of-death.html. Accessed October 24, 2016. 2. American Diabetes Association. Cardiovascular disease and risk management. Diabetes Care. 2016;39(Suppl. 1):S60-S71. 3. Schoen MW, Salas J, Scherrer JF, Buckhold FR. Cholesterol treatment and changes in guidelines in an academic medical practice. Am J Med. 2015;128:403-409. 4. Maddox TM, Borden WB, Tang F, et al. Implications of the 2013 ACC/AHA cholesterol guidelines for adults in contemporary cardiovascular practice: insights from the NCDR PINNACLE registry. J Am Coll Cardiol. 2014 Dec 2;64(21):2183-
92. 5. Tsuyuki, RT, Rosenthal M, Pearson GJ. A randomized trial of a community-based approach to dyslipidemia management: Pharmacist prescribing to achieve cholesterol targets (RxACT Study). Can Pharm J (Ott). 2016;149:283-292.
Adam Corey1, PharmD Candidate Corresponding author: Jennifer J Kim2,3, PharmD, BCPS, BCACP, CPP 1 UNC Eshelman School of Pharmacy, University of North Carolina at Chapel Hill, Chapel Hill, NC 27514, 2Department of Pharmacy, Moses H. Cone Memorial Hospital, Greensboro, NC 27401, 3Greensboro Area Health Education Center, Greensboro, NC 27401. Disclosure: This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors. This research was first presented in poster format at the NCAP Annual Convention, November 2016.
Abbreviations: ADA = American Diabetes Association, ASCVD = atherosclerotic cardiovascular disease, BMI = body-mass index, EMR = electronic medical record, IMC = Internal Medicine Center, IRB = institutional review board.
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Table 1. Current IMC Patients ON or NOT on Statin Therapy
ON Statin Therapy
Number
Percent
629
100%
450
NOT on Statin Therapy 179 Total Patients Included
71.5% 28.5%
IMC = Internal Medicine Center Table 2. Reasons Patients Lack Statin Therapy
Statin Lost from Profile
No History of Statin Use Documented Intolerance
Subsequently Added Patient Refused Therapy
Number (n=179)
Percent of NOT on Statin
65
36.3%
72
28 9
5
40.2%
15.6% 5.0%
2.8%
Table 3. ASCVD or Risk Factors of Patients Lacking Statin Therapy
Clinical ASCVD
ASCVD Risk Factors Hypertension
Number (n=179)
Percent of NOT on Statin
162
90.5%
40
22.4%
106
59.2%
Overweight/Obese
151
84.4%
Current Smoker
45
25.1%
Three Risk Factors
86
48.0%
Four Risk Factors
18
10.1%
LDL ≥ 100
Multiple Risk Factors
ASCVD = atherosclerotic cardiovascular disease
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Case Report
A Fatal Case of Loperamide Abuse Angela H. Pegram, Heather A.Kehr, Ronald Pollack
Abstract Introduction: Loperamide, a synthetic μ-opioid agonist, is normally used as an antidiarrheal agent that acts locally by inhibiting peristalsis of the intestinal tract. The US Food and Drug Administration issued a drug safety announcement in June 2016 regarding abuse and misuse of loperamide. High doses of loperamide may cause euphoria and reduce symptoms of opioid withdrawal but also could lead to serious heart problems and even death. Since the medication is relatively cheap and readily available, abuse potential is high. Case Report: A 23-year-old female with a history of polysubstance abuse, anxiety and depression presented with a syncopal episode. Initial EKG showed sinus tachycardia with 2:1 AV block; follow up EKG showed polymorphic ventricular tachycardia. The patient’s home medications were discontinued without recurrence of arrhythmia. Fourteen days after initial hospitalization, the patient presented with another syncopal episode and bradycardia with prolonged QT on EKG. She admitted to taking 48 loperamide tablets one week prior to admission. Her hospital course was complicated by a 38
worsening bradycardia and prolonged QT, cardiac arrest and subsequent placement of AICD. The patient recovered and was able to be discharged. Approximately 2 months later, the patient expired unexpectedly. Autopsy determined the cause of death to be loperamide and diphenhydramine toxicity. Discussion: In large and chronic doses, loperamide responds as other abused opioid drugs leading to QT prolongation, brady-arrhythmias and Torsades de Pointes. These cardiac abnormalities are usually only corrected with electrical pacing or cardioversion. In abuse cases, patients may also ingest other medications with loperamide, increasing its absorption across the blood-brain barrier, inhibit its metabolism and enhance its euphoric effects. Conclusion: Clinicians should consider loperamide-associated toxicity when QT prolongation, brady-arrhythmias or Torsades are present with a negative opioid drug screen. Introduction Loperamide is available as a prescription or over-the-counter (OTC) product that is marketed as a treatment for diarrhea. It works as a mu-opioid agonist in the digestive tract, reducing GI peristalsis. When taken at
Food and Drug Administration (FDA) approved antidiarrheal doses (16 mg/day for prescription products and 8 mg/day for OTC use), loperamide has the expected side effects of constipation, dry mouth, nausea and dizziness.1 Additionally, loperamide is unable to cross the blood brain barrier at these doses due to p-glycoprotein efflux.2 Over the past several years, there has been increasing information on the Internet describing loperamide misuse and abuse to self-treat opioid withdrawal syndrome or for recreational highs.3 This misuse of loperamide (median dose 250 mg, range of doses reported 70-1600 mg/day, 4 to 100 times the recommended dose) overcomes the p-glycoprotein efflux and allows the drug to cross the blood brain barrier, giving the user a euphoric high.2,4 More importantly, it has been noted that these very high and chronic doses are associated with cardiotoxicity which has been seen as QT prolongation, brady-arrhythmias, Torsades de Pointes and cardiac arrest.2,5-7 The FDA issued a drug safety communication regarding serious heart problems with loperamide abuse and misuse in June 2016. This safety communication also focused on other medications that may be taken
with loperamide which can increase the blood brain barrier penetration, inhibit metabolism and enhance the euphoric effects of the medication.4 This case report details a 23-year-old female with a history of polysubstance abuse who presents to the hospital with syncope and EKG changes on two occasions approximately 2 weeks apart. Two months later, the patient expired unexpectedly at home and an autopsy was performed to determine her cause of death. Case Report A 23-year-old female with a history of polysubstance abuse, anxiety and depression presented to the emergency room with a syncopal episode. She reported additional presyncopal and syncopal episodes periodically over the past two weeks. Her home medications included hydroxyzine, diphenhydramine, verapamil and duloxetine. The only new medication was the duloxetine which was started approximately one month prior. Due to her history of polysubstance abuse and a tendency to take too much medication, the patient’s parents dispensed her medications. The patient stated that she had not taken the hydroxyzine recently and denied taking any additional doses of her medications. Her urine drug screen (UDS) was positive for tricyclic antidepressants and benzodiazepines. Her initial electrocardiogram (EKG) showed sinus tachycardia with 2:1 AV block (Figure 1A). However, a follow-up EKG 23 minutes later showed poly-
morphic ventricular tachycardia (Figure 1B). Her home medications were all discontinued and she was hospitalized for three days. On the day of discharge, her EKG showed normal sinus rhythm and she was instructed not to restart any of the medications that were stopped (Figure 1C). She was discharged only on clonazepam three times a day for her anxiety. Fourteen days later, the patient presented to the emergency room with another presyncopal episode during which she hit her forehead but has no recollection of that event. The patient did endorse using a bottle of 48 loperamide tablets over a four day period one week prior to this episode for diarrhea caused by her anxiety, as well as stating that it helped calm her down. Her UDS at this time was positive for marijuana and benzodiazepines. Her initial EKG showed sinus bradycardia (46 bpm) with prolonged QT (640 ms; QTC 560 ms) (Figure 2A). She was admitted to the hospital and placed on cardiac telemetry for monitoring and given IV normal saline for hydration. The cardiology consult recommended daily EKGs and a short washout period to allow any possible ingested drugs to leave her system. Cardiology deferred placement of an automated internal cardiac defibrillator (AICD) at this time due to her anxiety. A psychology consult was also obtained to help manage the patient’s anxiety and depression. She was continued on her home clonazepam.
The patient’s bradycardia resolved on the day after admission, however, her QT interval remained prolonged. Over the next three days, her EKGs remained unchanged while she continued on the clonazepam and continuous normal saline infusion. The intravenous fluids were stopped on hospital day 3 due to the patient’s stable condition. On the fourth day of hospitalization, she was started on fluvoxamine for anxiety, which seemed to help her symptom control. However, the fluvoxamine was discontinued on hospital day 7 for concerns that it was contributing to the increase in her QT prolongation as well as episodes of asymptomatic ventricular tachycardia. On the morning of hospital day 9, the patient’s EKG showed sinus rhythm (79 bpm) with prolonged QT (620 mg; QTc 710 ms) but she was asymptomatic (Figure 2B). Early in that afternoon, the patient became hypotensive and bradycardic to the 50s. She was given a 1L bolus of normal saline and restarted on continuous normal saline. Approximately 5 hours later the patient again became hypotensive and bradycardic. At this time her EKG showed marked sinus bradycardia (35 bpm) with prolonged QT (562 ms; QTc 428 ms) (Figure 2C). The patient was transferred to the acute coronary care unit where she was started on dopamine, norepinephrine and a transvenous pacer. Due to the patient’s history of medication misuse and the finding of an empty verapamil bottle (which was previously full), 39
ingestion was suspected and a verapamil level was obtained which subsequently came back negative. The patient was able to be weaned from the vasopressors and transvenous pacer after two days. Her cardiac status remained stable, and she was transferred off the acute coronary care unit to the cardiac step-down floor with close telemetry monitoring on hospital day 13. On the evening of hospital day 14, the patient experienced an episode of Torsades as noted on telemetry and then became bradycardic with her EKG showing sinus bradycardia (42 bpm) and prolonged QT (588 ms; QTc 490 ms) (Figure 2D). A few minutes later, a code blue was called as the patient had agonal breathing and was unresponsive. Initially, she had a weak pulse and was in continuous Torsades but then went pulseless. After a 200 joule shock, the patient regained a pulse. She became responsive within seconds and was transferred to the acute coronary care unit for closer monitoring. For the next day and a half, she continued to have sinus bradycardia on EKGs. On hospital day 16, two days after her arrest, cardiology placed a dual chamber ICD. The patient’s EKGs normalized with paced rhythms until her discharge on hospital day 18 (Figure 2E). Approximately two months after her second hospitalization, the patient expired unexpectedly. An autopsy was performed which found an aortic blood loperamide level of 1.8 mg/L (1800 ng/mL) with a level 40
greater than 20 mg/kg in the liver and a diphenhydramine level in the liver of 37 mg/kg. All other toxicology screens were negative, including opioids. Discussion This case joins many others in the literature that confirm high doses of loperamide leads to cardiac toxicity and even death. A recent review of the FDA Adverse Event Reporting System (FAERS) from 1976 to 2015 found 48 cases of serious cardiac events associated with loperamide, with 10 of these cases resulting in death. With over half of the cases reported after 2010, this confirms a growing issue with loperamide misuse and abuse.2 These cases are just the ones reported to the FDA via the MedWatch system; there are likely many others that remain unreported. This patient had an unknown amount of loperamide intake, but on autopsy her blood levels were well above the maximum therapeutic concentration of 1.2 ng/mL.8 A toxic level for loperamide is currently not reported in the literature or by McNeil Consumer Healthcare, manufacturer of the branded Imodium® product. Liver levels of loperamide were also reported, but the clinical significance of these findings is not currently known. Another common finding of these case reports was the mixing of loperamide with other medications to enhance the euphoric effects. Drugs commonly seen were H2 antagonists
(cimetidine, ranitidine), macrolides (clarithromycin, erythromycin), azoles (ketoconazole, itraconazole), gemfibrozil and quinine. All of these drugs interact with loperamide by decreasing liver metabolism, increasing loperamide blood levels.4 Our case patient chose diphenhydramine, another easily obtained OTC product to augment the analgesic effect of loperamide. Diphenhydramine increases the levels/effects of opioids9, so using the two medications together likely gave her a pronounced euphoric effect. Although blood levels were not reported for diphenhydramine, the liver level found at autopsy was higher than that of loperamide, indicating a large ingestion of this medication as well. Unfortunately, loperamide misuse and abuse is not easy to detect. Standard drug screens are negative for opioids since loperamide is a synthetic opioid agonist. If loperamideinduced toxicity is expected, a loperamide blood level should be specifically ordered.4 Treatment of these cardiotoxicities caused by loperamide abuse has also been difficult to manage. Many times this is due to the other agents that patients use to augment their high. Pharmacotherapy seems to be ineffective in most cases and electrical pacing or cardioversion is usually necessary to break the arrhythmia.2 Another complication with this abuse is the increased half-life of loperamide with high doses used in abuse. In FDA approved doses the half-life is 9-13 hours, but this increases up to 41 hours
in doses higher than 16 mg.10 These long half-lives make the cardiotoxicity from this medication even more dangerous, as the drug clearance is slowed allowing the arrhythmia to continue for long periods of time. Conclusion Loperamide misuse and abuse is on the rise in all parts of the United States and should not just be considered a large inner city problem. This case patient was in small town North Carolina with the resulting cardiotoxicity seen at the local community hospital. Clinicians should consider loperamide-associated toxicity with cases of QT prolongation, brady-arrththmias or Torsades that are resistant to pharmacotherapy with a negative opioid drug screen. References 1. Lexicomp Online®, LexiDrugs®, Hudson, Ohio: Lexi-Comp, Inc. Loperamide; last updated 2017 March 3 [cited 2017 Mar 23]. 2. Swank KA, Wu E, Kortepeter C, McAninch J, Levin RL. Adverse event detection using the FDA post-marketing drug safety surveillance system: Cardiotoxicity associated with loperamide abuse and misuse. Journal of the American Pharmacists Association. 2017;57(2):S63S67. 3. Lasoff DR, Koh CH, Corbett B, Minns AB, Cantrell FL. Loperamide Trends in Abuse and Misuse over 13 years: 2002-
2015. Pharmacotherapy. 2017;37(2):249-253. 4. U.S. Food and Drug Administration. Loperamide (Imodium): Drug Safety Communication—serious heart problems with high doses from abuse and misuse. Available at: http:// www.fda.gov/Safety/MedWatch/SafetyInformation/ SafetyAlertsforHumanMedicalProducts/ucm505303. htm. Accessed March 23, 2017. 5. O’Connell CW, Schricker AA, Schneir AB, Metushi IG, Bigersdotter-Green U, Minns AB. High dose loperamide abuse-associated ventricular arrhythmias. Heart Rhythm Case Reports. 2016; 2(3):232236. 6. Spinner HL, Lonardo NW, Mulamalla R, Stehlik J. Ventricular Tachycardia Associated with HighDose Chronic Loperamide Use. Pharmacotherapy. 2015;35(2):234-238. 7. Marraffa JM, Holland MG, Sullivan RW, Morgan BW, Oakes JA, Wiegand TJ, Hodgman MJ. Cardiac conduction disturbance after loperamide abuse. Clinical Toxicology. 2014; 52(9):952-957. 8. Wightman RS, Hoffman RS, Howland MA, Rice B, Biary R, Lugassy D. Not your regular high: cardiac dysrhythmias caused by loperamide. Clinical Toxicology. 2016; 54(5):454-458. 9. Lexicomp Online®, LexiDrugs®, Hudson, Ohio: Lexi-Comp, Inc. Diphenhydramine; last updated
2017 March 23 [cited 2017 Mar 23].
10.Eggleston W, Nacca N, Marraff JM. Loperamide toxicokinetics: serum concentrations in the overdose setting. Clinical toxicology. 2015; 53(5): 495-496. Angela H. Pegram, PharmD, BCPS, CDE Associate Professor, Wingate University School of Pharmacy Wingate, NC Clinical Pharmacist, Cabarrus Family Medicine Inpatient Residency Program Concord, NC a.pegram@wingate.edu 704-233-8327 Corresponding author Heather A. Kehr, PharmD, BCPS Associate Professor, Wingate University School of Pharmacy Wingate, NC Clinical Pharmacist, Cabarrus Family Medicine Inpatient Residency Program Concord, NC hkehr@wingate.edu Ronald Pollack, MD Faculty and Attending Physician, Cabarrus Family Medicine Inpatient Residency Program Concord, NC This Case Report was first presented in poster format at the NCAP Annual Convention, November 2016. No Authors have any financial or other conflicts of interest to disclose in relation to this case report.
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Figures Figure 1. First hospitalization A. Initial EKG: sinus tach with 2:1 AV block
B. Follow up EKG (23 minutes later): polymorphic ventricular tachycardia
C. Discharge EKG (3 days later): normal sinus rhythm
Figure 2. Second Hospitalization (14 days later) A.
Initial EKG: sinus bradycardia (46 bpm) with prolonged QT (640 ms; QTc 560 ms)
B. Day 9 of hospitalization EKG: sinus rhythm (79 bpm) with prolonged QT (620 ms;
QTc 710 ms)
C. Day 9 of hospitalization EKG (19 hours later): marked sinus bradycardia (36
bpm) with prolonged QT (562 ms; QTc 428 ms)
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D.
Day 14 of hospitalization EKG: sinus bradycardia (42 bpm) with prolonged QT (588 ms; QTc 490 ms); patient coded shortly after this EKG
E.
Day 18 of hospitalization EKG (discharge): atrial paced rhythm; 70 bpm; QT 444 ms; QTc 479 ms
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Entrepreneurship A New Era in Pharmacy: Breaking Free From the Golden Handcuffs Anna Garrett Several years ago, I was working as a manager in a large health system. And while I enjoyed some aspects of my job, I could see the writing on the wall... and it wasn’t pretty. Rumors of layoffs swirled. Upper management talked constantly of our “gloom and doom” financial picture, and employee satisfaction was at an all-time low. The time seemed ripe to make a leap that I had contemplated for some time...starting my own business, coaching women who are experiencing challenges with perimenopause and menopause. I wanted to work directly with my clients and provide the care I knew they needed. But I also wanted the freedom that came with building a business I could do anywhere in the world. No matter where you practice, pharmacy has become more and more production-driven in an effort to drive down costs and save money. Think about it...has there been a time in the past week where you DIDN’T hear something about money and healthcare? Insurance companies have cut back reimbursements that mean less time to practice actual patient care. Burnout in retail pharmacy is rampant. Pharmacists are looking for a better way to do what they love, helping patients lead healthier lives and make best use of their medications. What keeps us stuck? It’s the Golden Handcuffs – we’re attached to our salaries, but the playing field is getting rough, causing burnout and dissatisfaction with what we’re doing versus why we started doing this in the first place. But so many of us think it’s just easier to stay where we are than forge a new path. But not all of us. Creative pharmacists are now taking matters into their own hands and stepping into entrepreneurship. And if you wonder what it is you could do and offer, just a quick search on Google reveals pharmacists who are providing MTM consultations, health coaching, starting “meds to beds” programs in health systems, offering transitions of care programs 44
as patients move from nursing facilities back their homes, and running online niche businesses. But what you won’t find much of is support for these entrepreneurs (and intrapreneurs) who are taking the leap. This is what led to the creation of the Medipreneurs 2017 event to be held in Asheville, NC this Fall. I joined forces with my colleagues and co-creators, Sue Paul, RPh and Michelle Fritsch, PharmD, to do something that has not been done before. The three of us feel passionately about helping entrepreneurs get off the ground and be a part of a community where they can network, learn about business from those who have done it, and get the support that is necessary to build their vision. We’ve each built businesses from scratch and are all too familiar with the challenges that must be navigated. Medipreneurs 2017 is an exclusive event for pharmacists who are ready to push some limits and gain freedom. We’re keeping it very small with limited seating so that the focus is on creating strong connections and learning from one another in an intimate setting. Coloring within the lines is no longer required for pharmacists. We can now have autonomy and stop being directed by higher ups, systems, and insurance companies. Speaking for Medipreneurs, I can say that we became pharmacists to improve patient care. I think the same is true for most pharmacists. And now we are proving that we have the power to bring the focus back to the patient and off the metrics and costs. If you’re frustrated, burnt out or have a vision for your practice that’s different from the reality you now know, the new era of pharmacy is here waiting for you. Ready to push against the edges of your comfort zone? Join us at Medipreneurs 2017 in Asheville, North Carolina, from September 30 to October 1, 2017. You’ll learn how to create a business that gives you freedom, money, and the ability to practice in a way that aligns with the reasons you became a pharmacist in the first place. For more information, visit www.medipreneurs.com. Anna Garrett, PharmD, is a menopause expert and Co-Founder of Medipreneurs.
In Memory BOARD OF PHARMACY EXECUTIVE EMERITUS DAVID R. WORK David R. Work, who served as the Board’s Executive Director from 1976 to 2006, passed away on Saturday, April 22, 2017. David is remembered, and will be forever remembered, as one of the giants of North Carolina pharmacy. His tenure as Executive Director saw enormous growth in the profession of pharmacy and seismic changes in the regulatory landscape. David navigated these changes expertly and, under his steady hand, the North Carolina Board emerged as, and remains, a progressive force for the advancement of the profession and protection of the public. David’s influence ranged far beyond North Carolina. His years of service to the National Association of Boards of Pharmacy, including as President, allowed him to help craft the future of the profession at the national and international level. Anyone who knew David will remember him as full of joy for life, possessed of a rapierlike wit, ever ready with his camera, and a constant source of sound advice. The Board members and staff, past and present, will miss him terribly. Our every thought turns to his daughters – Dana, Amy, and Susan – and their families. The French philosopher Paul Valéry said, “A great man is one who leaves others at a loss after he is gone.” Today, we are all at a loss. North Carolina Board of Pharmacy 45
