The Kentucky Pharmacists - May/June 2020 by Kentucky Pharmacists Association

Vol. 15 No. 3 May/June 2020

THE KENTUCKY

PHARMACIST Official Journal of the Kentucky Pharmacists Association

Congratulations Class of 2020!

Inside: Board of Directors Ballot Class of 2020

The Voice of Pharmacy in Kentucky

TABLE OF CONTENTS FEATURES

Mission Statement: The mission of KPhA is to advocate for and advance the profession through an engaged membership.

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KPhA Board of Directors Ballot |6|

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SARS-CO V-2 Vaccine Update |12|

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Pharmacist TB Reporting Requirements |13|

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Letter to KPhA Members—Richard Slone |14|

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Financial Forum |38|

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Rx and the Law |39|

On the Cover UKCOP & SUCOPHS 2020 Graduates

Editorial Office:

IN EVERY ISSUE

©Copyright 2020 to the Kentucky Pharmacists Association. The Kentucky Pharmacist is the official journal of the Kentucky Pharmacists Association published bi-monthly. The Kentucky Pharmacist is distributed to KPhA members, paid through allocations of membership dues. All views expressed in articles are those of the writer, and not necessarily the official position of the Kentucky Pharmacists Association.

President’s Perspective |3| My KPhA Rx |4| Campus Corner |8| May CE Article |16| May Quiz |24| May CE Answer Sheet |25| June CE Article |27| June Quiz |32| June Answer Sheet |33| Pharmacy Policy Issues |34| New KPhA Members |35| Pharmacy Law Brief |36|

Publisher: Mark Glasper Managing Editor: Sarah Franklin Editorial, advertising and executive offices at 96 C Michael Davenport Blvd., Frankfort, KY 40601. Phone: 502.227.2303 Fax: 502.227.2258. Email: info@kphanet.org. Website: www.kphanet.org.

ADVERTISERS

|2| Kentucky Pharmacists Association | May/June 2020

APSC|15| PTCB |26| EPIC |35| Pharmacists Mutual |40| Cardinal |41| APMS |Back Cover|

PRESIDENT’S PERSPECTIVE COVID-19 Perspective on Careers, KPhA & Life We are living in unprecedented times for many generations of Americans due to the COVID-19 crisis. I count myself blessed that my family, so far, has been healthy and I look forward to going back to church and showing thanks to our Maker for His protections. Until then, I have become familiar with services on the air or, more precisely, on my phone. Many of you know I have had a professional career which has spanned from independent pharmacy in my early years to hospital management and leadership roles. Along the way, I created an LLC to support my work as a consultant. I also have worked in long-term care pharmacy and recently with an independent compounding pharmacy. Now, I find myself working with pet meds for the largest pet pharmacy based on sales, Chewy. We are called “Chewtopians.” It is an amazing business; all online with shipping to all corners of the United States – perfect for working in the COVID-19 environment.

last in-person meeting held at KPhA prior to the COVID-19 crisis. Nothing is more important for our organization than to focus our initiatives on this program. I remember when we were working with Chair Kim Croley and our COE Committee on how this program Don Kupper would be the footprint on whatever direction we, as an President, KPhA association, would go. Tim is a true professional, guiding us to formulate the new KPhA Strategic Plan and now will help us develop activities to support COE fundraising. This is our focus and I hope you will join me in making a pledge to see KPhA/KPERF create a perpetual program for the future of the Pharmacy Profession in Kentucky.

In closing, I would like to remember a young man we “lost” “We are living in unprecedented times for many recently, Matt Boyd. Matt was a pharmacy student at SUCOPHS and was just starting his rotations. I was working at generations of Americans due to the COVID-19 my desk when one of our managers was relaying a story about crisis. “ Matt’s passion for running. However, the story had an unfortunate ending. When I eventually saw Matt’s picture, I reDuring this pandemic, we have had to postpone the normal membered meeting and speaking with him. Since then, I have activities of our Association. Instead of June, our Annual read some poignant social posts regarding him and our loss. Meeting is now scheduled for November 12-15, 2020 at the Pharmacy will continue on after this COVID-19 crisis; but we Marriott Louisville Downtown. Our KPhA staff is working to lost a promising member of our profession all too soon. pull the event’s social and educational activities together. I am hopeful we can reschedule the KPERF Golf Outing with no issues. I also have spent time looking at other state pharmacy associations to get a feel for how they are handling their business during this health crisis as well as their planning going forward. I will share this information with Executive Director Mark Glasper so he can combine this input with what he gathers in his daily communications with other state pharmacy execs. Having this national perspective will help guide our efforts as we work in the post COVID-19 world.

jobs.kphanet.org THE location for pharmacy job seekers + employers for targeted positions.

We recently invited fundraising consultant Tim Burcham to speak to the KPhA Executive Committee and the KPERF Board of Directors about our fundraising initiatives with the KPERF Center for Excellence Campaign. It was literally the KPhA sends email announcements weekly. If you aren’t receiving: eNews, Legislative Updates and other important announcements, send your email address to info@kphanet.org to get on the list. |3| www.KPHANET.org

MY KPhA Rx COVID-19 Causes Problems;  Two Town Hall teleconferences; Town Hall #1 RecordKPhA Creates Opportunities ing; Town Hall #2 Recording  By Mark Glasper KPhA Executive Director/CEO

Chair Chris Palutis appointed President-Elect Joel Thornbury chair of COVID-19 ad hoc Committee to monitor and develop products to help pharmacists coping with the COVID -19 crisis

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Committee members helped to generate “Best Practices The past three-plus months have been challenging and surreal, for Community Pharmacies” but productive. The COVID-19 crisis has turned our collec Committee members assisted the development of “Kentive world upside down. Your KPhA staff members have emtucky Pharmacists Ordering and Administering COVID-19 braced working remotely, pharmacists throughout the ComTesting” education with assistance from SUCOPHS and monwealth have altered their business/safety practices, and UKCOP with approval by KBOP pharmacy students have endured an interruption to their academic year, especially for the graduating classes. While the  KPhA Website Resources page effects of the COVID-19 crisis have been unsettling, we’ve all Annual Meeting Moves to November; still managed to persevere and push forward. Miss America Camille Schrier to Appear The COVID-19 crisis also played havoc with the KPhA Annual Meeting & Convention originally scheduled for June 1114, 2020. We recognized early on that we just were not going to be able to hold the event due to all of the COVID-19 restrictions on meetings of 10 or more people. Working with our host hotel, the Marriott Louisville Downtown, we were successful moving our Annual Meeting to November 12-15, 2020 without penalty. Staff is busy confirming speakers again and preparing to present the Annual Meeting KPhA staff (top row) Executive Director Mark Glasper, Direcprogramming virtually detor of Communications & CE Sarah Franklin, Director of Pharmacy Public Health Programs Jody Jaggers; (bottom pending on the status of the row) Director of Finance & Administrative Services Angela COVID-19 crisis. We’re still Gibson, Office Assistant/Member Services Coordinator Lisa planning to hold the same Atha and Director of Emergency Preparedness Michele Pinkgreat event, just at a different ston meet weekly via Zoom to keep the business of KPhA runtime of year. The only major ning smoothly. (Director of Pharmacy Clinical Outreach change will be the KPERF Kristin Blankenbecler not pictured.) Golf Scramble moving to a Problems Create Opportunities date earlier in the fall to enLike so many Kentucky businesses, KPhA staff have worked sure warmer temperatures. PharmD student and Miss Ameri- We are also working with remotely per Governor Andy Beshear’s recommendations. I’d like to commend staff for maintaining all member services ca Camille Schrier will appear at our valued exhibitors and in a seamless fashion. Together with engaged volunteer mem- the KPhA Annual Meeting & sponsors to hold all of the Convention November 12-15, bers, we’ve utilized technology and created new resources usual social events that 2020 at the Marriott Louisville which will help pharmacists and their patients now and in the Downtown. Save the Date now! you’ve come to enjoy. future. COVID-19 “highlights” include: Finally, have I mentioned problems create opportunities? By postponing our Annual Meeting to November, we were able  Daily e-blasts evolving into an as-needed timeframe to book PharmD student, Miss America Camille Schrier, for |4| Kentucky Pharmacists Association | May/June 2020

our event! We are still working out her appearance schedule, but Save the Date now to attend the KPhA Annual Meeting & Convention November 12-15, 2020 and meet Miss America! Colleges of Pharmacy, Students Finish School Year like no Other It seems incomprehensible that while college calendars and curricula were turned upside due to the COVID-19 crisis, not only did our colleges of pharmacy complete the school year but they did so while graduating students on time. No small feat, considering the adversity everyone faced back in March. We always like to feature student pages in every issue of Journal but we really wanted to make special mention of this yearâ&#x20AC;&#x2122;s UK and SUCOPHS graduating classes since they were unable to have their normal graduation ceremonies. Congratulations to all of the graduates and especially to the KPhA Award recipients! Please peruse pages 6-9 in this issue to enjoy the coverage.

We appreciate all of the students who attended the KPhA Pharmacy Day at the Capitol. Our future leaders of the profession impress legislators and make us proud.

Welcome New Staff Member Please join us in welcoming Kristen Blankenbecler to our staff! She fills the position of Director of Clinical Outreach. Kristen graduated with a Doctor of Pharmacy degree from Mercer University College of Pharmacy and Health Sciences in Atlanta, GA in 2012. She has experience in retail, hospital and ambulatory pharmacy and has served on a taskforce to help combat opioid use in part of rural Kentucky. She currently resides in Winchester, KY with her husband and two children. You can reach Kristen by email at kristen@kphanet.org

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KPhA Board of Directors Ballot Due to COVID-19 our ballot for the Board of Directors is delayed. We will send the electronic ballot soon! If you’d like a paper ballot, please contact us at info@kphanet.org or 502.227.2303. The following positions are up for election: President-Elect, Secretary, Director (3).

President-Elect Cathy Hanna

I strongly believe that pharmacists have the opportunity to greatly improve the health of our Kentucky communities and are a vital member of the healthcare team. An engaged membership is necessary to effectively carry out this role of the pharmacist.

My interest in serving as the KPhA President Elect stems from my long-standing interest in advancing the practice of pharmacy and promoting pharmacists as an integrated member of the healthcare team. While I have had the privilege of working to advance these goals through multiple venues, including my work as Vice President of Professional Affairs for the American Pharmacy Services Corporation (APSC) and my recent service on the KPhA Board of Directors, I am eager to serve as KPhA’s President Elect and further advance these goals and the goals of KPhA and its members.

KPhA/APhA Volunteer Experience: Kentucky Pharmacists Association (KPhA) | August 2003 to Present Government Affairs Committee | August 2017 to Present Director of Emergency Preparedness Search Committee | 2017 Public Affairs Committee | August 2016 to 2019 Secretary | July 2014 to Present Board of Directors | July 2014 to Present Executive Committee | July 2014 to Present Budget and Audit Committee | July 2014 to Present Provider Status Workgroup | July 2013 to July 2016 Professional Affairs Committee | September 2007 to July 2010 American Pharmacists Association (APhA) | August 2003 to Present Poster Judge | March 2016, 2017, 2018 Membership Engagement Focus Group | March 2016 APhA Academy of PharI graduated from the University of Kentucky with a BS in AG macy Practice and Management Diabetes Special Interest Group (SIG) | July 2013 to Present Diabetes SIG Student Economics in 1983 and earned a BS in Pharmacy in 1986. Engagement Committee | March 2017 to Present Diabetes After graduating from pharmacy school, I owned and manSIG Education Committee | March 2014 to March 2017 aged an independent long-term care pharmacy for many years, returning to UK to complete my PharmD degree in 2004. In my present role at APSC, I work with community Director pharmacists on policy, compliance, regulatory and operational issues. Ronnah Alexander I am passionate about pharmacy and continue to be an advocate for the profession. I am a long-standing member of KPhA and an active member of the Advancing Pharmacy Practice in Kentucky Coalition (APPKC).

As a Kentucky Pharmacist for over 30 years, I have had the privilege of opening 3 pharmacy locations both chain and independent in my career. In addition to this I have recently gained added experience with the If elected, I will bring my experience as a leader and advocate 340B program, working for a Federfor pharmacy to assist KPhA in meeting its strategic vision – to become a unified pharmacy profession empowered to max- ally Qualified Health Center. The recent changes to reimimize patient and public health as fully integrated members of bursements for our Kentucky Pharmacies in the last several years has been troubling as our independent pharmacies (the the healthcare team. backbone of our profession in our state), are suffering greatly. With my experience, I hope to help work toward solutions in Secretary our state for all pharmacists. I am a licensed Pharmacist in the State of Kentucky, with my Bachelors from the University Brooke Hudspeth of Kentucky College of Pharmacy. I also will be completing my MBA in Health Care from Strayer University It has been my honor to serve for the (Washington D.C.) in Sept. of 2020. largest professional organization representing pharmacists in the ComI am a member of KPHA, APHA, the Interagency of Hopmonwealth. As secretary and board member, I strive to live out our mis- kins Co, NACHC (The National Association of Community sion to advocate for and advance the Health Centers), it would be a privilege to serve my state pharmacists in the Director position. profession of pharmacy. |6| Kentucky Pharmacists Association | May/June 2020

Mary Hayes I want to help influence change for the pharmacy community. I believe that my background would offer a unique perspective to the organization and my contribution to the board would allow for a wide variety of pharmacists collaborating together to create a brighter future for the pharmacy community. Kyle Harris It has been my privilege to be part of an amazing profession for nearly nine years. During that time, I have witnessed many changes to the profession which have granted pharmacists greater roles in providing patient care which have allowed patients more access to healthcare and quicker initiation of treatments. Having worked in independent community pharmacy, specialty compounding and durable medical equipment, and long-term care, I have enjoyed learning of the impacts our profession can have on individual patients. I have also enjoyed the opportunity to work with other healthcare providers to display the level of knowledge and expertise we are able to contribute to patient care from working with nurses, physicians, and nurse practitioners in the skilled nursing facility to teaching physician assistants in the classroom.

Cory Smith Since being involved in the field of Pharmacy the past 10 years, I realize more and more every year the difference KPhA can make in advocating for and advancing our profession with the ultimate goal of better caring for patients. I am honored to accept this nomination. KPhA/APhA Volunteer Experience: KPhA New Practitioner Committee KPhA SB-50 Legislative meeting with Senators Robert Stivers and Max Wise, APhA Annual Convention 2014, SUCOP Student Representative Anthony Tagavi There would be no greater pleasure than to serve the profession of pharmacy and our commonwealth. With years of experience as a retail pharmacist, a pharmacy professor and a short time in a health system, I bring a unique perspective from all areas in pharmacy and would like to contribute to KPhA.

I have been honored, in my relatively short time in this profession, to have worked with many great pharmacists who have paved the way for future pharmacists. I feel it is time for me to give back to my profession in this way--doing all we can to be certain the patients of the Commonwealth receive the care and attention we, as pharmacists, are educated and trained to provide. Rene Kendrick I am interested in one of the three open positions on the Board of Directors. I served in a similar role for Indiana Pharmacists Alliance in the past and the position was very rewarding both personally and professionally. Thank you for your consideration! KPhA/APhA Volunteer Experience: KPhA, IPA, and APhA membership multiple years. Attending Annual meetings and Legislative reviews. Work with KPhA to roll out Naloxone certification for all Kroger RPhs.

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Campus Corner The Virtual Student in this New World Most of us reminisce when we think about our pharmacy school experience. Sometimes it was difficult, but we had our buddies in class to help us, whether it be with studying, or just keeping us uplifted and on track. But imagine if your only contact with classmates was through email, or Facebook, or in a virtual classroom.

can kiss our role as health-care providers good-bye. We are not graduating pharmacists to just check that the right medicine is in the right bottle. We are graduating pharmacists that can transform the way patients live so that their medication regimen will allow them to lead happy and productive lives. I am very proud of both the faculty and students at SU COPHS and their response to an extremely challenging situation. And I am proud of our profession for stepping up to screen, educate and care for patients throughout the commonwealth. Let’s keep innovation rolling.

Misty M Stutz PharmD Life is different for our students today. They have had to change and adapt in Dean and Professor ways we can only imagine. When the pandemic first hit, we Sullivan University College of Pharmacy and Health Sciences immediately had to move our classroom education to a remote learning experience. And one of the first things we learned was that although the information we deliver to students is still the same, the way we deliver it in the virtual classroom must be different. And what about skills-based activities that we thought could only be done in a dedicated lab space? Well, most of it can be done remotely, it just takes a lot of creCongratulations to KPhA Award ativity and innovation.

But one of the most challenging parts of the curriculum is ex- Recipient Luke Schmid periential. Yes, it is hard to be a health professional in this Luke Henry Schmid received the KPhA Association crazy time, but even harder to be a student. The ‘virtual’ world Professional Advocate Award. is especially difficult for our APPE students. If there is one Presented to a graduating student, this thing this pandemic has taught us, is that the lack of telehealth award recognizes an individual who or lack of how to use it properly has left students without sites, demonstrates dedication to the pharwithout preceptors and without patients. In a world where macy profession by active participation everyone connects via social media, we can’t seem to figure in professional organizations, a comout how to work as a team to take care of a patient without mitment to advocacy for the profesbeing in the same space. We have known for years that consion, and leadership potential. necting to our patients virtually is an option, and yet we act as if accessing data at a location off the physical site will lead to violations of HIPAA and ‘seeing’ patients via video conference will not lead to positive outcomes. Although I never would have imagined that our lives in the academic world would be turned upside down so acutely, I do believe that this has sent us a message. Life is not stagnant, and change and innovation are our keys to success, both as educators and practitioners. Now is our time to change. As pharmacists have been given liberties of practice during this state of emergency, and we must rise to the occasion and change the trajectory of our profession. We have got to continue to say YES to opportunities and ask for reimbursement of these activities. We have the knowledge and skills to help in ways that others cannot. In another year, this pandemic will be over. And where will we be as a profession? If we are still just counting and pouring and complaining about why we can’t be paid for a product, we |8| Kentucky Pharmacists Association | May/June 2020

Our Deepest Sympathies Matthew Owen Boyd, Louisville, 24, of Louisville, passed away unexpectedly Sunday, May 10, 2020. He was a student of Sullivan University's College of Pharmacy and a graduate of the University of Louisville and DeSales High School. Our thoughts and prayers are with his family, friends and SUCOPHS classmates and educators.

Best Wishes to our new SUCOPHS Graduates! KPhA would like to congratulate the 2020 graduating class from the Sullivan University College of Pharmacy and Health Sciences. There are 87 Class of 2020 graduates receiving their PharmD from SU COPHS. 12 graduates have also completed requirements for a dual degree (Master of Business Administration). 10 of the 2020 PharmD graduates will be completing a PGY1 Pharmacy Practice Residency!

New Practitioners First Year Receive Free KPhA Membership: Donâ&#x20AC;&#x2122;t forget to utilize your FREE KPhA membershipâ&#x20AC;&#x201D; career center, free CE, networking opportunities and more!

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Campus Corner Dear Class of 2020, Congratulations! You've made it. For one hundred fifty years, the University of Kentucky College of Pharmacy has led pharmacy education, practice, and research. And you are now part of that legacy. Our story goes beyond the confines of our building, our research labs, and our classroom walls. It's the story of a group of people tirelessly working together to elevate care and save lives. Your graduation represents an honor in your career in recognition of your hours in the clinic, the classroom, and the laboratory.

bership or in recognition of a symbolic membership. Each coin signifies a major achievement. Our graduates are awarded the UKCOP challenge coin during their graduation ceremony as a recognition of their membership into our family and a reminder to "pay it forward," by continuing our legacy of innovation, collaboration, and excellence. The coin is a piece of the College for you to keep with you in recognition of everything you've accomplished, as well as our belief in your ability to push for greatness. I challenge each of you to continue the proud tradition of excellence in whatever path you take.

R. Kip Guy, PhD We stand together with you as a community committed to transforming care. This pharmacy family is devoted to tending Dean & Professor to our community and doing well by it. We're dedicated to UK College of Pharmacy pushing past the status quo and fighting for a better tomorrow. This is not just your story, it's a story about all of us. It's about how we go beyond-beyond the script. In celebration of your accomplishments, you will also receive a UKCOP challenge coin. The challenge coin is a military tradition, which bears the emblem of the branch or organization it represents. A coin is often given to show a sign of mem-

Congratulations to the KPhA Award Recipients KPhA Excellence In Geriatric Practice Award Emily Nicole Followell For a graduating student in good academic standing who has demonstrated interest in geriatric pharmacy practice through achievements in geriatric-focused coursework and/or experiential education. Sponsored by the Kentucky Pharmacists Association Section for Consultant Pharmacists.

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KPhA Outstanding Graduating Man and Woman Awards Shelby Spencer Tungate and Miley Girgis Nikirk For the outstanding man and woman graduating from the College as chosen by classmates and based on scholarship and contribution to the profession and the College. Sponsored by the Kentucky Pharmacists Association.

Best Wishes to our new UKCOP Graduates! KPhA would like to congratulate the 2020 graduating class from the University of Kentucky College of Pharmacy. There were 136 graduates receiving their PharmD from UKCOP and 11 more graduates who received their PhD (8 in 2019, 2 in 2020). Thirty-one graduates also completed requirements for a dual degree (Master of Science (10), Master of Business Administration (12), Master of Public Administration (3), and Master of Public Health (6)). 54% of the 2020 PharmD graduates will be completing a PGY1 Pharmacy Practice Residency! Be sure to congratulate the class of 2020 on all of these accomplishments!

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Feature Article SARS-CoV-2 Vaccine Update Author: Michele Pinkston, KPhA Director of Pharmacy Emergency Preparedness Nearly every day news organizations are reporting on the race to find a coronavirus (SARS-CoV-2) vaccine. As pharmacists we recognize that the path from identifying a potential vaccine to approval for marketing is never straight and narrow. In fact, it is a long and winding road filled with challenges and setbacks.1 Currently, scientists and pharmaceutical companies are attempting to identify, develop, research, produce, and distribute a vaccine for SARS-CoV-2 in less than 2 years. If successful, this would be the fastest vaccine development in history.2 Since the SARS-CoV-2 genetic code was first identified in early 2020, there has been rapid advancement toward discovery of a safe and effective vaccine. To date, the WHO reports that at least 136 trials are underway (10 clinical trials and 126 preclinical studies).3 Companies are using many different approaches to vaccine development from established techniques to novel gene therapy. Nearly all the techniques are focusing on the spike protein portion of the coronavirus. The spike protein attaches to human cells and allows the virus to be transferred through the cell membrane. 4 An effective vaccine would result in immune system production of antibodies that would target and disable the protein and, in turn, inactivate the virus. The more traditional approach to vaccine development includes utilizing either the whole virus (live/attenuated or inactivated) to help the body develop antibodies or utilizing a virus protein or portion of the virus protein (recombinant or particle) to create an immune response.5 Human vaccines currently marketed were developed through conventional techniques. These techniques have the advantage of years of Compound Name AZD1222

successful production of safe and effective vaccines. The drawback is the time this development takes. The other, more novel, approaches involve gene-based vaccines. The genome for SARS-CoV-2 was first published by Chinese researchers on January 10th.2 Researchers are using this genome to make blueprints of viral DNA and RNA which will be injected into human cells. The viral DNA would be delivered inside the human cell via plasmid while messenger RNA is carried by lipids into the cell.2 Once inside, the genetic material instructs the cells to make a viral protein antigen. The immune system recognizes the protein and develops antibodies to combat the virus. Some researchers are utilizing a viral vector method of introducing the genetic material into the body. This method utilizes other viruses such as adenovirus as carriers for the RNA.2 The adenovirus is nonreplicating so it cannot cause illness, but it provides an easier mechanism for delivering the genetic material into the human cell. Unlike traditional methods, gene-based vaccine development does not require large amounts of virus for production allowing for a potentially faster, less expensive vaccine.6 The research into gene-based vaccines is very exciting yet prior to the COVID-19 outbreak, no large-scale clinical trials had been performed and no DNA or RNA vaccine for human use has been approved. It is possible that the traditional method, with decades of vaccine success, will be the ultimate producer of a safe and effective SARS-CoV-2 vaccine. Because researchers and scientists are dealing with a novel virus and an unknown path to prevention, it is wise not to rely on one method alone for discovery. Compressing a research and development timeline from 10 years to under 2 years, requires testing many methods at the same time, working together as a scientific community, and maybe a little luck. SARS CoV-2 Vaccines in Clinical Trials3

Developer(s)

Platform

University of Oxford and AstraZeneca

Viral Vector Adenovirus

Development Phase Phase 2b/3

mRNA

Phase 2

Ad5-nCoV

Moderna (Cambridge, MA); NIAID/ BARDA CanSino Biologics

Viral Vector Adenovirus

Phase 2

NVX-CoV2373

Novavax

Phase 1/2

BNT162 Unnamed

BioNTech and Pfizer Sinopharm/Beijing Institute of Medical Biological Products Sinopharm/Wuhan Institute of Biological Products Sinovac

Recombinant Protein Based mRNA Inactivated Virus Inactivated Virus

Phase 1/2

Inactivated Virus plus adjuvant DNA Inactivated Virus

Phase 1/2

mRNA-1273

Unnamed PiCoVacc INO-4800 Unnamed

Inovio Institute of Medical Biology and Chinese Academy of Medical Sciences

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Phase 1/2 Phase 1/2

Phase 1 Phase 1

Pharmacist TB Reporting Requirements Although rates are low in Kentucky, tuberculosis is diagnosed in patients every year in the state and it is vital that our health departments be informed of all active cases. The regulation governing tuberculosis and other infectious disease reporting, 902 KAR 2:020 â&#x20AC;&#x201C; Reportable Disease Surveillance, gives pharmacists a key role in TB surveillance in the commonwealth. This regulation has been in effect since February 2015 and requires that pharmacists give notice to the local health department or the Kentucky Department for Public Health when two or more medications (see list below) used for the initial treatment of active tuberculosis are dispensed to a patient. The requirement to report extends to inpatients in a healthcare facility or to ambulatory patients in a healthcare facility or pharmacy: Section 15. Tuberculosis. (1) A pharmacist shall give notice if two (2) or more of the following medications used for the initial treatment of active tuberculosis are dispensed to an inpatient in a health facility or to an ambulatory patient in a health facility or a pharmacy: (a) Rifampin or rifabutin; (b) Isoniazid; (c) Pyrazinamide; and (d) Ethambutol. (2) A report of tuberculosis shall be considered priority and shall be reported to the local health department serving the county in which the patient resides. (3) If the local health department cannot be reached, notification shall be given to the Kentucky Department for Public Health. (4) The report shall include: (a) Information required in Section 4(16) of this administrative regulation; and (b) Names of the medications dispensed. Pharmacists may utilize the Kentucky Reportable Disease Form (Epid TB-1 Pharmacist Reporting) to report the appropriate information. This report may also be found on the Kentucky Board of Pharmacy website. The report may be faxed to the local health department where the patient resides. A directory for local health departments with fax numbers can be found at the following web address: https://chfs.ky.gov/agencies/dph/dafm/Pages/lhd.aspx If unable to report to the local health department, the information may be faxed to the KDPH TB Prevention and Control Program at (502) 564-3772. Pharmacists can also phone the office directly at 502-564-4276. The full Reportable Disease Surveillance regulation, 902 KAR 2:020, can be found at https://apps.legislature.ky.gov/law/ kar/902/002/020.pdf.

Member News Jesica Mills was named the Kentucky representative to the States Forum of Pharmacist Birth Control Services by the KPhA Board of Directors. The Birth Control Pharmacist project provides education and training, implementation assistance, resources, and clinical updates to pharmacists prescribing contraception, as well as engaging in advocacy, research and policy efforts to expand the role of pharmacists in family planning. They also maintain the Birth Control Pharmacies site and directory for people across the country to find a participating pharmacy where they can obtain contraception directly from a pharmacist.

Submit Member News: info@kphanet.org |13| www.KPHANET.org

Letter to KPhA Members By Richard Slone, KPhA Member, KPhA Board of Directors; Co-Chair, Government Affairs Committee; KPhA Past President

Richard Slone

To all members of the Kentucky Pharmacists Association, I would just like to say thank you for allowing me to serve on the Board of Directors and in various other leadership capacities over the last 15 years. I regret that I will not be on the ballot this year to serve another threeyear term as your Board Member. Normally, I would have an opportunity to see and speak with you at the Annual Meeting but it will be held in November, so it is possible that the new Officers will be installed before that.

sent Medicaid reform that is a national model for other states to follow. And, Onco 360 now allows pharmacists to expand their practice and services to patients through protocols. To be successful in the legislative arena pharmacists must be engaged at all levels, including local, state and national, to engage those leaders and politicians that affect our profession through laws and regulations. There are more positive legislation results we achieved that were either passed or affected by KPhA during the last nine years. Pharmacy has many more battles to fight including adequate compensation for professional services. This Association represents all practice settings of our profession. To achieve success, all facets must respect and appreciate each other and must work together for the common good of our profession and our Association.

Once again it has been an honor and privilege to serve as a Member of the KPhA Board of Directors and the Government Affairs Committee, both of which have many dedicated and hard-working members. It has been an honor to serve with them and I hope that my participation in all things related to the Association have been done with honor, integrity, respect, and professionalism. My duty was to serve the Board, the Association and our profession to improve the practice of pharmacy that will enable us to serve our patients to the best of our During my tenure on the Board the staff has grown from three abilities. to seven full-time employees. Some of those positions are Thank you for allowing me to serve. funded by numerous grants that the Association has obtained from state and federal sources. It is a complement to this Asso- Richard Slone I would like to say that it has been a privilege and honor to serve as a KPhA Board Member. I would like to thank our staff for the great job that they have done and continue to do. Executive Director Mark Glasper has done an outstanding job leading this team. The last few months have been very difficult for our staff to function normally due to the COVID-19 crisis, but with his leadership and guidance and great staff teamwork, they have continued to move this Association forward.

ciation that dues income is just a small portion of the total income source. However, we are a member driven organization. It is each memberâ&#x20AC;&#x2122;s obligation to become engaged and to promote membership to those who are not members in the premier organization of our profession in the commonwealth of Kentucky. For the past nine years, I have been Chair or Co-chair of the Government Affairs Committee. During this time major gains have been made for our profession through the legislative process. Senate Bill 117 in the 2017 legislative session was about PBM reform, which required PBMs to register with the Department of Insurance, provided a process to appeal MAC pricing, and gave DOI the ability to fine PBMs for inappropriate behavior. The 2019 legislative session brought us SB 5 which started the cascade of events that led us to SB 50 in the 2020 legislative session. These two bills allow the state to break the veils and shrouds of the PBM industry and to pre|14| Kentucky Pharmacists Association | May/June 2020

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May CPE Article Pharmacologic Review of Heart Failure Authors: Miley G. Nikirk, PharmD; Tracy E. Macaulay PharmD, AACC, BCPS (AQ Cardiology), BCCP The authors declare that there are no financial relationships that could be perceived as real or apparent conflicts of interest. Universal Activity # 0143-0000-20-005-H01-P 1.0 Contact Hours (0.1 CEU) Expires 6/30/23

KPERF offers all CE articles to members online at www.kphanet.org

Goal: The goal of this article is to inform pharmacists and pharmacy technicians of recent updates to the adult and child and adolescent vaccination schedules recommended by the Centers for Disease Control and Prevention (CDC). Learning Objectives: At the conclusion of this Knowledge-based article, the reader should be able to: Understand the prevalence of HFpEF and HFrEF, and their impact on the United States Health Care System. Recognize patients at increased risk of developing heart failure. Discuss pharmacologic options for patients with heart failure and considerations when choosing agents.

Introduction

Epidemiology and Classification of Heart Failure

Heart failure (HF) is a complex, progressive disease associated with high risk of morbidity and mortality. Nearly 6.2 million adults in the United States are affected by heart failure. Heart failure is the primary diagnosis in about 1 million hospitalizations and a secondary diagnosis in about 2 million hospitalizations annually.1 The one-month readmission rate of heart failure patients is approximately 25% within 30 days of discharge.2 The utilization of guideline-directed medical therapy (GDMT) and proper application of medication recommendations is vital for overall disease management. The goals of treatment in heart failure are to reduce mortality, improve prognosis and to manage symptoms by delaying or reversing the dysfunction.

Heart failure develops when structural and/or functional cardiac abnormalities result in the heart being unable to pump blood and oxygen to meet the metabolic demands in the body. The impairment of ventricular filling or ejection of blood is most commonly caused by reduced left ventricular myocardial function. This is a result of the damaged heart muscles secondary to coronary artery disease. The function of the heart depends on adequate contractility, preload and afterload. The dysfunction of the endocardium, myocardium, pericardium, heart valves or great vessels in combination or alone are also associated with heart failure.4 Although clinic efforts target early reperfusion therapy and growth in postacute coronary syndrome (ACS) care, previous occurrence of myocardial ischemia continues to be the most common precipitate of heart failure in the United States.5 Regardless of the etiology, the activation of the sympathetic nervous system and RAAS proceeds in the ongoing progression of heart failure after the initial fall in cardiac output. Therefore, blocking these mechanisms yield pharmacotherapy targets for heart failure.4

In patients with heart failure with reduced ejection fraction (HFrEF), the use of target doses of evidence-based betablockers, maintenance of fluid status and renin-angiotensin aldosterone system (RAAS) blockade have long-been the mainstay of pharmacotherapy management. The emergence of an angiotensin receptor-neprilysin inhibitor (ARNI) and discovery of cardiovascular benefits from specific sodiumglucose cotransporter 2 (SGLT2i) inhibitors have shown promise for disease control and offer new options. Despite advancements in care, more than 8 million people in the United States (1 in every 33) will have heart failure by 2030.3 Pharmacists have the opportunity to participate in optimization of medications, patient education medication access, and drug-related care in all pharmacy practice settings to assist in addressing the long-term trajectory of heart failure.

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Unfortunately, there is no single test utilized to diagnose HF, thus diagnosis is determined by thorough history and physical examination. Medication and social history should be obtained for additional workup to identify cause or the worsening of underlying HF. The assessment of heart function should be conducted when patients present with clinical symptoms consistent with HF. The gold standard to estimate left ventricular ejection fraction (LVEF) is echocardiogram but various modalities can be used to determine heart function. Identifying the LVEF in patients with clinical heart failure permits the classification of HF as preserved EF (HFpEF) or reduced EF (HFrEF).

ology. Managing symptoms and slowing disease progression are components of treating heart failure. Decreasing mortality rates is necessary but without heart transplant or placement of mechanical circulatory support devices such as left-ventricular assist devices, mortality rates continue to be significant.8 The hallmark symptoms of HFpEF and HFrEF are similar including decreased exercise tolerance, dyspnea, fatigue and pulmonary edema as a result from decreased cardiac output. The clinical significance of peripheral edema is also the product of excessive fluid retention. Peripheral edema generates other common clinical findings such as hepatojugular reflex and jugular venous distention. This can be a tool to assess volume balance during treatment and throughout heart failure progression. The disease severity can also be established by measuring natriuretic peptides, specifically B-type natriuretic peptide (BNP) or N-terminal pro B-type natriuretic peptide (NT-proBNP).9

Image 1. American Heart Association; HF and Your Ejection Fraction Explained

Underlying cardiovascular (CV) risk factors can precipitate the formation and/or worsening of HF. Comorbidities such as ischemic heart disease, arrhythmias, valvular disease, takotsubo (stress) cardiomyopathy and cardiotoxins are common disorders that cause HF. Other cardiomyopathies that are less frequent that result in HF are alcohol, genetic disorders and viral infections. HF has primarily been established as a disease in older patients, greater than 60 years old. The Framingham Heart Study concluded that hypertension is one of the earliest identifiable risk factors for coronary heart disease and incident of HF.11 Hypertension is the most prevalent causes of HFpEF because of ventricle stiffening. HFpEF has been confirmed in patients of older age and higher incidence of HF in women compared to men in repeated studies.11 The incidence of HFrEF in women is notably low in women and decreased more over time.

Disease severity and risk for HF decompensation should be carefully considered when evaluating comorbidities and as independent targets for therapy. Diabetes mellitus and pulmo Preserved EF (diastolic): greater than or equal to 50%, nary disease exist in 30% to 40% of patients hospitalized with decrease filling HF and impact severity.12 Congestion can be precipitated by  Reduced EF (systolic): less than or equal to 40%, dekidney dysfunction which can limit GDMT. The rates of HF crease contractility hospitalizations in African American patients over the past 20 years has continued to be more than twice of white patients  “Borderline” or “Improved LVEF: 41%-49% and declines in age-standardized HF rates.11 It is therefore imThe occurrence of HFpEF and HFrEF in the United States is portant to prevent atherosclerotic heart disease and establish equal in proportions, where the distinction between the two Image 2. CDC; Heart Failure Death Rate per 100,000, 35+, All types remains important both clinically and prognostically.7 Races/Ethnicities, Both Genders, 2014-2016 in Kentucky The American Heart Association 2019 update revealed that the prevalence of HFpEF compared to HFrEF appears to rise gradually with age in HF patients.1 LVEF is used in the majority of clinical trials for patient enrollment making the evaluation of EF important for GDMT.

Clinical Presentation Clinical presentation of HF is the outcome of decreased oxygenation to end organs and/or harmful attempts of the body to compensate for declined oxygen delivery, regardless of eti|17| www.KPHANET.org

lifelong management of HF risk factors. The American Heart Association has determined Life’s Simple 7 as 7 risk factors patients can improve through lifestyle changes to achieve cardiovascular health. The goals are to optimize profiles in BMI, blood pressure, cholesterol, diet, glucose control, physical activity and smoking. Primary prevention of HF can be augmented by patient adherence to the Life’s Simple 7 by decreasing the lifetime risk of HF and more favorable echocardiographic parameters of cardiac function and structure.1

classification, a patient who manifests NYHA class III symptoms may improve to NYHA class II function subsequently received diuresis.7 Effective GDMT for patients with HFrEF exists, but there are no therapies thus far that exhibit measurable benefit in HFpEF.13 Given the circumstance, continuation of GDMT during hospital stay or initiation prior to discharge is associated with considerable better outcomes.12 Both of these are due to the benefit of the therapies and to improve the prognosis of tolerable patients.

Guideline-Directed Medical Therapy for Treatment of Heart Failure

Treatment Goals for Stages A and B HF

The 2013 Guidelines for the Management of HF were generated by the collaboration of the American College of Cardiology Foundation (ACCF) with the American Heart Association (AHA).7 The class of the recommendation or the risk versus benefit, and the level of evidence established as the strength of the available evidence from clinical trials and studies are the foundation of guideline treatment recommendations. The highest recommendation that an intervention should be conducted based on data from various randomized clinical trials is represented as class IA recommendations. The purpose of treatment guidelines is to recommend therapy to prevent hospitalizations and to reduce morbidity and mortality. The initiation and optimizing of GDMT is based on the echocardiography findings of preserved or reduced EF and the ACCF/AHA stages for HF. 7 The ACCF/AHA stages define the progression of HF from A to D:4 Stage A: High risk of heart failure, but no structural heart disease or symptoms of heart failure; Stage B: Structural heart disease, but no symptoms of heart failure; Stage C: Structural heart disease and symptoms of heart failure;

Management of HF targets to decrease mortality, control symptoms and improve prognosis. Agents that have proven to reduce mortality in HF are vasodilators, beta-blockers and aldosterone antagonists. The vasodilators include angiotensinconverting enzyme inhibitors (ACEi), angiotensin receptor blockers (ARB), angiotensin receptor-neprilysin inhibitor (ARNI) and hydralazine/nitrates.14 Pharmacologic agents utilized to manage HF symptoms are diuretics, digoxin and ivabradine, which have demonstrated to improve mortality along with decrease HF hospitalizations. The recommendations for stage A HF are to prevent the development of clinical HF by controlling hypertension and hyperlipidemia (class IA).7 The objective is to reduce the progression of HF by treating comorbidities such as the AHA’s Life’s Simple 7. Limiting exposure or withdrawing cardiotoxic agents should also be considered (class IC).7 Identifying medications and their potential harm for causing or worsening HF was issued by AHA in 2016, condensed example in Table 1.6 GDMT stage B recommendations for patients with HFrEF include utilizing an ACEi or ARB (if intolerant to ACEi) (class IA) and beta-blocker (class IC) for medication therapy. Patients with a prior medical history of ACS or a myocardial infarction should also receive stating therapy with HFrEF (class IA).

Stage D: Refractory heart failure requiring specialized interventions.

Pharmacologic Agents for Stage C HFpEF

Once a patient has developed structural heart disease with symptoms, ACCF/AHA stage C, the patient cannot reverse the disease progression back to stage B. In regard to NYHA

agent to consider for treatment of HFpEF. The recommendation of aldosterone antagonists therapy is appropriate in se-

Data supporting therapies for the treatment of HFpEF are lacking (Table 2).9 The American College of Cardiology The New York. Heart Association (NYHA) defines the (ACC)/AHA/Heart Failure Society of America (HFSA) 4 functional classes and symptoms of HF: guidelines were updated in 2017 and recommend in patients with HFpEF and hypertension to target blood pressure goals Class I: No limitation: ordinary physical activity does not to less than 130/80 mm Hg (class IC-LD) when implementing cause undue fatigue, dyspnea, or palpitation GDMT.9 No treatments have been proven to effect mortality Class II: Slight limitation of physical activity: Patients are in HFpEF patients but some agents have exemplified the decomfortable at rest. Ordinary physical activity results in facrease in hospitalizations, resulting in reduction of morbidity. tigue, palpitation, dyspnea, or angina The Candesartan in Heart Failure: Assessment of Reduction in Mortality and Morbidity (CHARM) clinical trial illustrated Class III: Marked limitation of physical activity: Although no significant difference in the primary outcome of CV death patients are comfortable at rest, less than ordinary activity will or HF hospitalizations. The trial did validate a compelling lead to symptoms decrease in the individual prespecified component of HF hospitalizations with candesartan use, resulting in the class IIbB Class IV: Inability to carry on any physical activity without recommendation from the ACCF/AHA 2013 guidelines. 15 discomfort. Symptoms of congestive failure are present even at rest The aldosterone antagonist, spironolactone is the second

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lected stage C HFpEF patients with (class IIbB-R) to decrease hospitalizations:9 EF â&#x2030;Ľ 45% Elevated BNP levels or HF admission within 1 year Estimate glomerular filtration rate > 30 mL/min

Pharmacologic Agents for Stage C HFrEF The 2017 updated ACCF/AHA 2013 guidelines expanded the current recommendations and integrated two FDA approved medications for the treatment of stage C HFrEF, sacubitrilvalsartan and ivabradine.7,9 The recommendations and pharmacologic agents from both the 2013 and 2017 guidelines are provided below in Table 3.

Creatinine < 2.5 mg/dL Potassium < 5.0 mEq/L Studies suggest that the mechanism of aldosterone antagonists can enhance measures of diastolic function in HFpEF patients, similar to remodeling. The Treatment of Preserved Cardiac Function Heart Failure with an Aldosterone Antagonist (TOPCAT) trial compared spironolactone to placebo in patients with HFpEF.9 The investigation did not discover a difference in the combined endpoint of death or aborted cardiac death, however there was a reduction in HF hospitalizations. The TOPCAT trial stimulated a regional post hoc analysis based on the amount of regional variation, which concluded a significantly higher placebo event rate in the American subgroup than the Russia/Georgia subgroup. This contributed to the potential benefit of spironolactone in HFpEF patients.9

Heart Rate-Reducing Agents Beta-adrenergic blockers are used for neurohormonal modification, improvement of HF symptoms, prevention of arrythmias, control of ventricular rate and survival benefit in HF patients.4 The three landmark trials, the Cardiac Insufficiency Bisoprolol Study II (CIBIS II), Metoprolol CR/XL Randomized Intervention Trial in Congestive Heart Failure (MERIT-HF), and US Carvedilol Heart Failure Study provides data and evidence for use of bisoprolol, carvedilol and metoprolol succinate in patients with HFrEF.18-20 These trials were conducted in patients with NYHA Class II-III HFrEF and all indicated substantial reduction in mortality, including sudden cardiac death. The results from the three trials provided strength to the 2013 ACC/ACCF/AHA guideline recommendations for the use of either bisoprolol, carvedilol or metoprolol succinate to decrease morbidity and mortality in stage C HFrEF patients (class IA).7

ARNI is the newest agent that received FDA approval in 2015. The angiotensin receptor-neprilysin inhibitor is composed of valsartan, targeting the angiotensin receptor, and sacubitril, inhibiting neprilysin. Neprilysin in the enzyme that breaks down natriuretic peptides, including bradykinin and substance P. The Prospective Comparison of Angiotensin Receptor Neprilysin Inhibitor with Angiotensin Receptor Blocker Global Outcomes in HFpEF (PARAGON-HF) trial evalu- Beta-blocker selection:7 ated the safety and efficacy of sacubitril-valsartan versus an Bisoprolol 2.5 mg daily (target dose10 mg daily) ARB with published results in March 2020. The PARAGONHF trial found that HFpEF patients treated with sacubitrilCarvedilol 3.125 mg twice daily (25 mg twice daily, 50 valsartan did not result in significant lower rates of total cardimg twice daily if > 85 kg) ovascular deaths or hospitalizations as compared to valsarMetoprolol Succinate 12.5-25 mg daily (200 mg daily) tan.16 The trial failed to show that ARNI decreased adverse events among HFpEF patients. An extended look at these Contraindicated in patients with symptomatic patients from the PARAGON-HF trial evaluated the effects of bradycardia, symptomatic hypotension or ARNI on N-terminal pro B-type natriuretic peptide with anticsevere lung disease ipated results in May 2020.17 Patients may experience increase in shortness of breath, fatigue, edema or weight gain during titration

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estimated 20% will experience an ACEi-induced cough.9 The ACEi-induced cough is derived from the inability to breakdown bradykinin in the lungs.9 As previously mentioned, if this occurs, the patient may switch therapy to an ARB (class IA).7 Unfortunately some patients may develop angioedema even on an ARB after being considered an alternative therapy. Patients with high for development of angioedema, such as Ivabradine was introduced in 2015 to lower heart rate via the African Americans, should be assessed for prior history of inhibition of hyper-polarized activated cyclic nucleotide-gated ACEi-related angioedema when substituting to an ARB.22 21 channels. Ivabradine has no effect on blood pressure which is contrary to some of the beta-blockers.22 The Systolic Heart Failure Treatment with If Inhibitor Ivabradine Trial (SHIFT) in 2010 was a randomized, placebo-controlled trial that evaluate the treatment of ivabradine in patients with NYHA Class II-III HF with an LVEF < 35%.23 The enrolled patients were allowed to continue GDMT such as beta-blocker therapy. The results from SHIFT provided a significant reduction in the primary composite outcome of HF hospitalization or CV death but is driven by decrease in HF symptoms. The trial data prompted the 2017 ACC/ AHA/HFSA guideline recommendation of the utilization of ivabradine (IIa B-R) to decrease HF hospitalizations in NYHA Class II-III patients with stable chronic HFrEF9 The patient must be hemodynamically stable when initiating beta-blockers. GDMT with beta blockers establishes initiation at the lowest dose and titrating no more frequently than every 2 weeks. The target doses should be acquired in 8 to 12 weeks. The abrupt discontinuation of therapy may worsen HF and raise risk of early death where patients should be advised.

Ivabradine:9 Ivabradine 5 mg twice daily (7.5 mg daily) Target heart rate 50-60 BPM Consider use in patients with LVEF < 35% and HR > 70 BPM despite maximally tolerated betablocker dose Consider in patients that have beta-blocker contraindications

ACE inhibitors:7 Captopril 6.25 mg three times daily (100 mg three times daily) Enalapril 2.5 mg twice daily (10 mg twice daily) Lisinopril 2.5 mg daily (40 mg daily) Indicated in all HFrEF patients classified as NYHA Class I-IV

Contractility Agents

Start low and titrate slowly to targeted dose as tolerated Digoxin is used in symptom management of HF to increase contractility by inhibiting the sodium-potassium ATPase.24 Contraindicated in patients with angioedema, The Digitalis Investigation Group (DIG) trial was executed in potassium level > 5.5 mEq/L, anuric renal 1997 to compare the use of digoxin versus placebo in patients failure, symptomatic hypotension, pregnanwith EF < 45%. The results of the trial demonstrated no sigcy and bilateral renal artery stenosis nificant difference in CV deaths or all-cause mortality but did 7 25 ARB selections: statically decrease HF hospializations. The findings of the DIG trial contributed to the 2013 ACC/AHA guideline recCandesartan 4 mg daily (24 mg daily) ommendation of digoxin use in appropriate patients to de7 crease hospitalizations (class IIaB). Losartan 25 mg daily (100 mg daily) Digoxin:7

Valsartan 40 mg twice daily (160 mg twice daily)

Digoxin dose usually 0.125 g/day, serum digoxin concentration should be < 1 ng/mL Consider use in patients with left ventricular systolic dysfunction who have signs/symptoms of HF despite optimal therapy Monitor changes in renal function or potassium

Indicated in patients unable to tolerate ACEi Start low and titrate slowly, no more frequently than every 2 weeks to targeted dose as tolerated Goal to complete titration in 3 to 6 months Contraindications are the same as ACEi

The Prospective Comparison of ARNI with ACEI to Determine Impact on Global Mortality and Morbidity in Heart Failure (PARADIGM-HF) trial was a randomized, doubleACE inhibitors have established benefits of reducing morbidiblind trial consisting of NYHA Class II-IV HFrEF patients. ty and mortality in patients with symptomatic HFrEF This trial determined sacubitril-valsartan as a novel for theraamongst various clinical trials. Less than 1% of patients on an py in HFrEF patients with stabled GDMT.27 ACEi will experience the adverse event of angioedema but Afterload/Preload Pharmacologic Agents

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The 2017 ACC/AHA/ HFSA guidelines recommend the use of sacubitril-valsartan (ARNI), in patients that previously tolerated ACEi or ARB therapy (class IB-R).9 Switching from an ACEi to ARNI requires a 36 hour washout period to reduce the risk of angioedema (class III B-R).9 The 36 hour washout period is not warranted when switching from an ARB to sacubitril-valsartan or vice versa. Switching from sacubitrilvalsartan back to an ACEi due to intolerability would require a 36-hour observation interval off of ARNI prior to the first dose of ACEi. The dose conversions from an ACEi to ARNI are displayed in Table 4.26 The starting dose for ARNI should be higher if the patient was previously on vasodilators. The dose should be titrated every 2 to 4 weeks for patients previously on higher doses of ACEi or ARB. Patients previously on low-dose ACEi or ARB should dose increase ARNI every 4 to 6 weeks.

Indicated in African American patients with HFrEF (must be on ACEi and still having elevated blood pressure ~ 120 mm HG

Patients with hypertension (systolic > 140 mm Hg) despite ACEi (or ARB/ARNi)

Patients with contraindications to ACEi (or ARB/ARNI)

d. Contraindications for use in patients with lupus Diuretics for Volume Overload

Similar to treatment of HFpEF, there is significant evidence supporting the use of aldosterone antagonists in HF patients with reduced ejection fraction. The 2017 ACC/AHA Guidelines recommend the use of spironolactone or eplerenone in all patients with NYHA Class II-IV HFrEF (class IA).9 This recommendation comes from the RALES and EMPHASISARNI therapy:9 HF trials that showed a significant decrease in mortality with use of these drugs. As was mentioned with treatment of Sacubitril/valsartan 24/26 (or 49/51) mg twice daily HFpEF above, patient-specific considerations should be made (97/103 mg twice daily) when using aldosterone antagonists in these agents. For example, caution should be used in patients with hyperkalemia a. Indicated in all HFrEF patients receiving optimal man(potassium > 5.0 mEq/L) and severe kidney dysfunction agement (beta-blocker, aldosterone antagonist) with a (creatinine > 2.5 mg/dL). Guidance for dose decreases and systolic blood pressure > 100 mm Hg discontinuations can be found in the 2017 ACC/AHA Guideb. Creatinine clearance must be â&#x2030;Ľ 30 mL/min prior to initialines. tion Aldosterone Antagonists9 c. Do NOT use if on ACEi, must have a washout period of 36 hours when switching Spironolactone 25 mg daily (50 mg daily) d. Contraindications are the same as ACEi

Eplerenone 50 mg daily

Doses of diuretics may need to be reduced due to natriuretic effects from role of sacubitril inhibiting neprilysin

Indicated in patients with HFrEF and HF symptoms NYHA Class II- IV

If patient is on hydralazine-isosorbide dinitrate, the dose should be reduced when adding ARNI to avoid hypotension

Spironolactone is first line option; switch to eplerenone if patient develops gynecomastia or hirsutism

The use of hydralazine-isosorbide dinitrate (H-ISDN) is recommended for use in African Americans on GDMT by the ACC/AHA guidelines.7,26 The Vasodilator-Heart Failure Trial (VHeFT) I trial randomized mild to severe HF patients to receive placebo, prazosin or combination of H-ISDN. The trial was the first to indicate a substantial reduction in patients treated with H-ISDN.28 A few years after the VHeFT II trial was conducted with patients of similar enrollment but they received either enalapril or H-ISDN. The VHeFT II trial determined a decrease in all-cause mortality in patients receiving enalapril treatment.29 African American patients, compared to white patients, had separate benefits from vasodilator therapy with H-ISDN compared to ACEi treatment in a retrospective analysis of VHeFT I and VHeFT II trials.30 The African American Heart Failure Trial (A-HeFT) was then generated to investigate the benefits of H-ISDN versus placebo in African American patients receiving ACEi or ARB, beta-blocker and spironolactone.26 The outcomes of reduction in all-cause mortality and hospitalizations for HF patients treated with HISDN lead to the guideline recommendation.

Doses can be halved for serum potassium 5.0-5.5 mEq/L Loop diuretics including furosemide, torsemide, and bumetanide are frequently used for symptomatic management of volume overload in patients with HFpEF and HFrEF 9. These drugs are beneficial for symptom relief but may activate the renin-aldosterone-angiotensin-system (RAAS) because they increase sodium excretion in the urine. Loop Diuretics Oral Equivalency9 Bumetanide 1 mg Torsemide 10 mg Furosemide 40 mg Use lowest dose for shortest duration for symptomatic management Monitor for hypokalemia and hypomagnesemia

Hydralazine/Nitrates:9,26 Hydralazine 25 mg/Isosorbide dinitrate 20 mg three times daily (100/40 mg three times daily) |21| www.KPHANET.org

The Emergence of Sodium-Glucose Cotransporter 2 Inhibitors in Heart Failure Treatment The sodium-glucose cotransporter 2 (SGLT2) inhibitors have previously been approved for the indications to treat type 2 diabetes mellitus (DM) as an adjunct to diet and exercise to enhance glycemic control. The inhibition of sodium-glucose cotransporter 2 reduces the risk of a first hospitalization for heart failure, possibly through glucose-independent mechanisms.31 Canagliflozin (Invokana) and empagliflozin (Jardiance) have revealed reduction in CV death and hospital admissions for HF patients with cardiovascular disease (CVD) and DM. Dapagliflozin (Farxiga) has also been shown to reduce hospital admissions for HF patients with CV disease and DM. The 2019 American Diabetes Association (ADA) Standards of Medical Care in Diabetes state that patients with cardiovascular disease already on metformin should be started on a drug with known cardiovascular protection, highlighting SGLT2 inhibitors as an option.31 The SGLT2 inhibitors for primary and secondary prevention of cardiovascular and renal outcomes in type 2 diabetes: a systematic review and metaanalysis of cardiovascular outcome trials found that SGLT2 inhibitors reduced major adverse cardiovascular events by 11% with benefit shown in patients with and without atherosclerotic CVD. The SGLT2 inhibitors also decreased the risk of CV death or hospitalization for heart failure by 23% and risk of progression of renal disease by 45%.32 The Canagliflozin and Cardiovascular and Renal Events in Type 2 Diabetes, CANVAS, integrated data from two trials in 2017. Canagliflozin was associated with a statistically significant lower composite of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke when compared to placebo. The trial showed a possible, not statistically significant, benefit in the progression of albuminuria and composite outcome of sustained reduction of estimated glomerular filtration rate (eGFR), need for renal replacement therapy or death from renal causes.33 Of all of the medications in this class, empagliflozin has demonstrated the most cardioprotective effects compared to placebo as found in the EMPA-REG OUTCOME trial. The 2015 Empagliflozin, Cardiovascular Outcomes, and Mortality in Type 2 Diabetes (EMPA-REG OUTCOME) proved that empagliflozin was associated with a statistically significantly lower composite of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke.34 The trial also displayed significantly lower rates of death from cardiovascular causes, hospitalization for heart failure, and death from any cause.34 Empagliflozin is FDA approved for CVD benefit. In patients with established atherosclerotic cardiovascular disease, chronic kidney disease (CKD) or heart failure (HF) and on metformin, empagliflozin is a preferred add-on agent to lower major adverse cardiovascular events and/or slow progression of HF/CKD, provided baseline renal function is sufficient to initiate therapy per ADA 2019 guidelines.31 The Dapagliflozin and Cardiovascular Outcomes in Type 2 Diabetes (DECLARE-TIMI 58) trial published in January 2019, presented that dapagliflozin was shown to have a statistically significant lower rate of cardiovascular death or hospitalization from heart failure.35 Dapagliflozin was shown noninferior to placebo for major adverse cardiovascular events but |22| Kentucky Pharmacists Association | May/June 2020

did not result in a statistically significantly lower rate in them. The trial did indicate dapagliflozin to have statistically significantly lower rates of renal events measured by a composite of sustained low eGFR, new end-stage renal disease or death from renal causes.35 The cardiovascular effects of dapagliflozin were recently studied in the Dapagliflozin in Patients with Heart Failure and Reduced Ejection Fraction (DAPA-HF) trial that was published in November 2019. The other SGLT2 inhibitors that have yet to be studied for this indication. The DAPA-HF trial demonstrated that dapagliflozin lowers the risk of heart failure including hospitalization or urgent visits, death from cardiovascular causes and fewer symptoms in patients with reduced ejection fraction and heart failure with or without diabetes.36 HF patients in NYHA functional Class III or IV appeared to have less benefit than those in Class II. Regardless of the presence or absence of diabetes, dapagliflozin was as effective in the 55% of patients without type 2 diabetes compared to those with diabetes.36 Occurrence of adverse events related to hypoglycemia, renal dysfunction and volume depletion did not change between dapagliflozin and placebo groups. The DAPA-HF trial is promising for dapagliflozin, but further studies need to be established for FDA approval, as well as cost savings and patient safety. Additional Resources: American College of Cardiology: Succeed in Managing Heart Failure Initiative https://www.acc.org/tools-and-practice-support/qualityprograms/succeed-in-managing-heart-failure-initiative American College of Cardiology: TreatHF https://www.acc.org/tools-and-practice-support/mobileresources/features/treathf American Heart Association: Heart Failure Guidelines Toolkit https://www.heart.org/en/health-topics/heart-failure/heartfailure-tools-resources/heart-failure-guidelines-toolkit Heart Failure Clinical Pharmacy Services: Milfred-LaFores SK, Chow SL, DiDomenico RJ, et al. Clinical pharmacy services in heart failure: an opinion paper from the Heart Failure Society of American and American College of Clinical Pharmacy Cardiology Practice and Research Network. Pharmacotherapy.2013;33(5):529-548. Heart Failure Society of America: Patient Tools http://www.hsfa.org/patient/patient-tools/educationalmodules/ Transitions of Care Resources: ASHP-APhA Medication Management in Care Transitions Best Practices https://www.ashp.org/-/media/assets/pharmacy-practice/ resource-centers/quality-improvement/learn-about-qualityimprovement-medication-management-care-transitions.ashx Heart Failure Charter https://static1.squarespace.com/ static/5d48b6eb75823b00016db708/ t/5df26d00b8b4c6785fa44e9c/1576168705126/ Heart+failure+Charter+11.11.19+NTOCC.pdf

Metoprolol CR/XL Randomised Intervention Trial in Congestive Heart Failure (MERIT-HF). Lancet. 1999;353(9169):2001-2007. doi: 10.1016/S0140-6736(99) 04440-2.

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Packer M, Bristow MR, Cohn JN, et al. The effect of carvedilol on morbidity and mortality in patients with chronic heart failure. U.S. Carvedilol Heart Failure Study Group. N Engl J Med. 1996;334(21):1349-1355.

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Heidenreich P.A., Albert N.M., Allen L.A., et al. (2013) Forecasting the impact of heart failure in the United States: a policy statement from the American Heart Association. Circ Heart Fail 6: e606-619.

Corlanor [FDA prescription label]. Thousand Oaks, CA: Amgen; 2015. https:// www.accessdata.fda.gov/drugsatfda_docs/label/2019/209964lbl.pdf. Accessed April 13, 2020.

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Inamdar AA, Inamdar AC. Heart failure: diagnosis, management and utilization. J Clin Med. 2016;5(7). doi: 10.3390/jcm5070062.

Joannides R., Moore N., Jacob M., et al. Comparative effects of ivabradine, a selective heart rate-lowering agent, and propranolol on systemic and cardiac haemodynamics at rest and during exercise. Br J Clin Pharmacol. 2006;61(2):127-137. doi: 10.1111/j.1365-2125.2005.02544.x.

Heidenreich PA, Albert NM, Allen LA, et al; American Heart Association Advocacy Coordinating Committee; Council on Arteriosclerosis, Thrombosis and Vascular Biology; Council on Cardiovascular Radiology and Intervention; Council on Clinical Cardiology; Council on Epidemiology and Prevention; Stroke Council. Forecasting the impact of heart failure in the United States: a policy statement from the American Heart Association. Circ Heart Fail. 2013;6(3): 606-619. doi: 10.1161/HHF.0b013e318291329a.

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Gheorghiade M., Adams K.F Jr., Colucci W.S. Digoxin in the management of cardiovascular disorders. Circulation. 2004;109(24):2959-2964. doi: 10.1161/01.CIR.0000132482.95686.87.

Pagell, R.L., O’Bryant C.L., Cheng D., et al; American Heart Association Clinical Pharmacology and Heart Failure and Transplantation Committees of the Council on Clinical Cardiology; Council on Cardiovascular Surgery and Anesthesia; Council on Cardiovascular and Stroke Nursing; and Council on Quality of Care and Outcomes Research. (2016) Drugs that may cause or exacerbate heart failure: a scientific statement from the American Heart Association. Circulation. 2016;134 (6):e32-e69. doi: 10.1161/CIR.0000000000000426

25.

Perry G, Brown E, Thornton R, et al; Digitalis Investigation Group. The effect of digoxin on mortality and morbidity in patients with heart failure. N Engl J Med. 1997;336(8):525-533. doi: 10.1056/NEJM199702203360801.

26.

Taylor A.L., Ziesche S., Yancy C., et al; African-American Heart Failure Trial Investigators. Combination of isosorbide dinitrate and hydralazine in blacks with heart failure [Erratum in N Engl J Med. 2005;352(12):1276]. N Engl J Med. 2004;351 (20):2049-2057. doi: 10.1056/NEJMoa042934.

27.

McMurray JJ, Packer M, Desai AS, et al; PARADIGM-HF Investigators and Committees. Angiotensin-neprilysin inhibition versus enalapril in heart failure. N Engl J Med. 2014;371(11):993-1004. doi: 10.1056/NEJMoa1409077.

28.

Cohn J.N., Archibald D.G., Ziesche S., et al. Effect of vasodilator therapy on mortality in chronic congestive heart failure. Results of a Veterans Administration Cooperative Study. N Engl J Med. 1986;314(24):1547-1552. doi: 10.1056/ NEJM198606123142404.

29.

Cohn J.N,. Johnson G., Ziesche S, et al. A comparison of enalapril with hydralazine-isosorbide dinitrate in the treatment of chronic congestive heart failure. N Engl J Med. 1991;325(5):303-310. doi: 10.1056/NEJM199108013250502.

30.

Carson P., Ziesche S., Johnson G., Cohn J.N. Racial differences in response to therapy for heart failure: analysis of the vasodilator-heart failure trials. VasodilatorHeart Failure Trial Study Group. J Card Fail. 1999;5(3):178-187.

31.

American Diabetes Association. “Pharmacologic Approaches to Glycemic Treatment: Standards of Medical Care in Diabetes-2019.” Diabetes Care, American Diabetes Association, 1 Jan. 2019. Retrieved March 26, 2020, from https:// care.diabetesjournals.org/content/diacare/ suppl/2018/12/17/42.Supplement_1.DC1/DC_42_S1_2019_UPDATED.pdf

Yancy CW, Jessup M, Bozkurt B, et al; American College of Cardiology Foundation; American Heart Association Task Force on Practice Guidelines. 2013 ACCF/AHA Guideline for the Management of Heart Failure: a Report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2013;62(16):e147-e239. doi: 10.1016/ j.jacc.2013.05.019.

Braunwald E. The war against heart failure: the Lancet lecture. Lancet. 2015;385 (9970):812-824. doi: 10.1016/S0140-6736(14)61889-4.

Yancy CW, Jessup M, Bozkurt B, et al. 2017 ACC/AHA/HFSA Focused Update of the 2013 ACCF/AHA Guideline for the Management of Heart Failure: a Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Failure Society of America. J Am Coll Cardiol. 2017;70(6):776-803. doi: 10.1016/j.jacc.2017.04.025.

10.

Centers for Disease Control: Mortality in the United States, 2018. NCHS Data Brief. 2020; No.335. Retrieved from April 1, 2020 from https://www.hiv.gov/hivbasics/overview/data-and-trends/statistics

11.

Pfeffer, M.A., Shah, A.M., Borlaug, B, A. (2019) Heart failure with preserved ejection fraction in perspective. Circulation Research. 124: e1598-1617. doi: 10.1161/ CIRCRESAHA.119.313572.

12.

Hollenberg, S.M., Stevenson, L.W., et al. 2019 ACC Expert Consensus Decision Pathway on Risk Assessment, Management, and Clinical Trajectory of Patients Hospitalized With Heart Failure: A report of the American College of Cardiology Solution Set Oversight Committee. J Am Coll Cardiol. 2019;74(15):1966-2011. doi: 10.1016/j.jacc.2019.08.001

32.

Zelniker TA, et al., “SGLT2 inhibitors for primary and secondary prevention of cardiovascular and renal outcomes in type 2 diabetes: a systematic review and meta-analysis of cardiovascular outcome trials.” Lancet. 2019 Jan 5;393(10166):3139. doi: 10.1016/S0140-6736(18)32590-X. Epub 2018 Nov 10. PubMed PMID: 30424892.

13.

Hsu, J.J., Ziaeian, B., Fonarow, G.C. (2017) Heart failure with mid-range (borderline) ejection fraction: clinical implications and future directions. J Am Coll Cardiol. 2017:5(11):763-771. doi: 10.1016/j.jchf.2017.06.013.

33.

Neal, B., et al. “Canagliflozin and Cardiovascular and Renal Events in Type 2 Diabetes.” New England Journal of Medicine, 17 Aug. 2017, www.nejm.org/doi/ full/10.1056/NEJMoa1611925.

14.

Yancy CW, Jessup M, Bozkurt B, et al. 2016 ACC/AHA/HFSA Focused Update of New Pharmacological Therapy for Heartfailure: An Update of the 2013 ACCF/ AHA Guideline for the Management of Heart Failure: a Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Failure Society of America. Circulation. 2016; 134 (13) e282-293. doi: 10.1161/CIR.0000000000000435.

34.

Zinman, B,, et al. “Empagliflozin, Cardiovascular Outcomes, and Mortality in Type 2 Diabetes” New England Journal of Medicine, 26 Nov. 2015, www.nejm.org/doi/full/10.1056/NEJMoa1504720.

35.

Wiviott,, S.D., et al. “Dapagliflozin and Cardiovascular Outcomes in Type 2 Diabetes” New England Journal of Medicine, 24 Jan. 2019, www.nejm.org/doi/ full/10.1056/NEJMoa1812389.

36.

McMurray, J. J.V., et al., “Dapagliflozin in Patients with Heart Failure and Reduced Ejection Fraction” New England Journal of Medicine, 21 Nov. 2019, https://www.nejm.org/doi/10.1056/NEJMoa1911303

15.

Yusuf S., Pfeffer M.A., Swedberg K., et al; CHARM Investigators and Committees. Effects of candesartan in patients with chronic heart failure and preserved leftventricular ejection fraction: the CHARM-Preserved Trial. Lancet. 2003;362 (9386):777-781. doi: 10.1016/S0140-6736(03)14285-7.

16.

Solomon S.D., McMurray J.J.V., Anand I.S., et al. Angiotensin–Neprilysin Inhibition in Heart Failure with Preserved Ejection Fraction. N Engl J Med. 2019;381 (17):1609-1620.

17.

Cunningham J.W., Vaduganathan M, Claggett B.L., et al. Effects of Sacubitril/ Valsartan on N-Terminal Pro-B-Type Natriuretic Peptide in Heart Failure With Preserved Ejection Fraction.JACC Heart Fail 2020; 8(5): May 2020 doi: 10.1016/ j.jchf.2020.03.002

18.

CIBIS-II Investigators and Committees. The Cardiac Insufficiency Bisoprolol Study II (CIBIS-II): a randomised trial. Lancet. 1999;353(9146):9-13.

19.

MERIT-HF Study Group. Effect of metoprolol CR/XL in chronic heart failure:

|23| www.KPHANET.org

May 2020 â&#x20AC;&#x201D; Pharmacologic Review of Heart Failure 1. Which of the following is NOT a cause of heart failure? A.MI B.HTN C.Diabetes D.Valvular heart disease

7. Which of the following is needed prior to initiation of sacubitril/valsartan? A.SBP > 100 mm Hg on initiation B.SBP > 120 mm Hg on initiation C.SBP > 140 mm Hg on initiation D.Concomitant use of ACE inhibitor

2. True/False: The prevalence of heart failure is greater in men than in women. A.True B.False

8. What is the equivalent oral torsemide dose to 40 mg furosemide PO? A.1 mg B.10 mg

3. Which one of the following medications can cause the most significant exacerbation of heart failure?

C.20 mg D.40 mg

A.Amphetamine salts 15 mg daily B.Pregabalin 75 mg twice daily C.Pioglitazone 15 mg/metformin 500 mg twice daily D.Glipizide XR 5 mg once daily

9. Which cardioselective beta blocker is the optimal choice for a 58-year-old male patient experiencing symptomatic hypotension, has BP 118/76 mm Hg, and a resting HR of 66 bpm? A.Metoprolol tartrate

4. Which of the following beta-blockers has NOT been shown to reduce mortality in patients with HFrEF? A.Bisoprolol

B.Atenolol C.Bisoprolol D.Pindolol

B.Propranolol C.Carvedilol D.Metoprolol succinate

5. In a patient with stable HFrEF, how frequently should beta-blockers be titrated toward goal doses?

10. Which of the following SGLT2 inhibitors have been shown to reduce cardiovascular risk in patients with known type II diabetes and heart failure? A.Canagliflozin B.Dapagliflozin

A.Every 2 days

C.Empagliflozin

B.Every 2 weeks

D.All of the above

C.Every 6 weeks D.Every 2 months

6. Which of the following does not reduce mortality in HFrEF patients? A.ACE inhibitors B.Aldosterone antagonists C.Beta blockers D.Digoxin

|24| Kentucky Pharmacists Association | May/June 2020

This activity is a FREE service to members of the Kentucky Pharmacists Association. The fee for non-members is $30. Mail completed forms to: KPERF, 96 C Michael Davenport Blvd., Frankfort, KY 40601. Credit will be applied to your CPE Monitor Profile.

Expiration Date: 6/30/2023 Successful Completion: Score of 80% will result in 1.0 contact hour or .1 CEUs. TECHNICIANS ANSWER SHEET May 2020 — Pharmacologic Review of Heart Failure Universal Activity # 0143-0000-20-005-H01-T Name _______________________________________________KY Cert. # __________________________________ Address ______________________________________________Email_____________________________________ PLEASE CIRCLE THE APPROPRIATE ANSWERS: 1. A B C D 3. A B C D 5. A B C D 7. A B C D 9. A B C D 2. A B 4. A B C D 6. A B C D 8. A B C D 10. A B C D Information presented in the activity: Met my educational needs ___Yes ___No Figures and tables were useful ___Yes ___No Achieved the stated objectives ___Yes ___No Posttest was appropriate ___Yes ___No Was well written ___Yes ___No Commercial bias was present ___Yes ___No Is relevant to my practice ___Yes ___No If yes, please explain on a separate sheet. Unmet Objectives:______________________________________________________________________________ I hereby certify that I completed this self-study program independently and without assistance from any other party. Signature ____________________________________________Completion Date___________________________ Personal NABP eProfile ID #__________________________ Birthdate _______ (MM)_______(DD)

PHARMACISTS ANSWER SHEET May 2020 — Pharmacologic Review of Heart Failure

Universal Activity #0143-0000-20-005-H01-P Name _______________________________________________ KY Lic. # __________________________________ Address ______________________________________________Email_____________________________________ PLEASE CIRCLE THE APPROPRIATE ANSWERS: 1. A B C D 3. A B C D 5. A B C D 2. A B 4. A B C D 6. A B C D

7. A B C D 8. A B C D

9. A B C D 10. A B C D

Information presented in the activity: Met my educational needs ___Yes ___No Figures and tables were useful ___Yes ___No Achieved the stated objectives ___Yes ___No Posttest was appropriate ___Yes ___No Was well written ___Yes ___No Commercial bias was present ___Yes ___No Is relevant to my practice ___Yes ___No If yes, please explain on a separate sheet. Unmet Objectives:______________________________________________________________________________ I hereby certify that I completed this self-study program independently and without assistance from any other party. Signature ____________________________________________Completion Date___________________________ Personal NABP eProfile ID #_____________________________ Birthdate _______ (MM)_______(DD)

The Kentucky Pharmacy Education & Research Foundation is accredited by The Accreditation Council for Pharmacy

Quizzes submitted without NABP eProfile ID # and Birthdate cannot be accepted. |25| www.KPHANET.org

Have an idea for a continuing education article? WRITE IT! Continuing Education Article Guidelines The following broad guidelines should guide an author to  completing a continuing education article for publication in The Kentucky Pharmacist.  



Average length is 4-10 typed pages in a word processing document (Microsoft Word is preferred).



Articles are generally written so that they are pertinent to both pharmacists and pharmacy technicians. If the subject matter absolutely is not  pertinent to technicians, that needs to be stated clearly at the beginning of the article.



Article should begin with the goal or goals of the overall program – usually a few sentences.



Include 3 to 5 objectives using SMART and measurable verbs.



Feel free to include graphs or charts, but please submit them separately, not embedded in the text of the article.

|26| Kentucky Pharmacists Association | May/June 2020



Include a quiz over the material. Usually between 10 to 12 multiple choice questions. Articles are reviewed for commercial bias, etc. by at least one (normally two) pharmacist reviewers. When submitting the article, you also will be asked to fill out a financial disclosure statement to identify any financial considerations connected to your article. Articles should address topics designed to narrow gaps between actual practice and ideal practice in pharmacy. Please see the KPhA website (www.kphanet.org) under the Education link to see previously published articles. Articles must be submitted electronically to the KPhA director of communications and continuing education (info@kphanet.org) by the first of the month preceding publication.

June CPE Article Polypharmacy: How Medication Complexity Requires More Attention Author: University of Kentucky, Abbigail Collins; Megan Ma; Joanna Ng, MPH; Mark Huffmyer,

PharmD, BCGP, BCACP, CACP; Daniel C. Moga, MD, PhD The authors declares that there are no financial relationships that could be perceived as real or apparent conflicts of interest. Universal Activity # 0143-0000-20-006-H05-P &T 1.0 Contact Hour (0.10 CEU) Expires 6/30/23

KPERF offers all CE articles to members online at www.kphanet.org

Learning Objectives: At the conclusion of this Knowledge-based article, the reader should be able to:

1. Define polypharmacy 2. Recognize the importance of identifying polypharmacy as a health-related issue that needs attention from health providers 3. Identify the most at-risk populations for polypharmacy 4. Use existing tools to help mitigate polypharmacy Introduction As the U.S. population ages and the practice of medicine continues to advance, health care professionals hear terms such as ‘polypharmacy’ and ‘deprescribing’ being used in everyday health care vernacular. These are concepts that need to be better understood by health care providers caring for patients in general and older patients in particular. When polypharmacy is not managed properly in the older population, undesirable outcomes such as increased adverse events, hospitalization, lower quality of life, and health care economic burden manifest. Patients at higher risk of experiencing polypharmacy exhibit the following :  Increasing age (greater or equal to 65 years of age)  Multiple co-morbidities  Multiple providers assisting in their medical care  Unaccounted for over-the-counter medications such as vitamins, supplements, and herbal products Combating polypharmacy requires a holistic approach in viewing a patient’s medication list. Pharmacists play an essential role in overseeing the process of medication reconciliation when addressing polypharmacy. There is appropriate versus inappropriate polypharmacy and pharmacists must be able to differentiate between these two concepts to recommend deprescribing. Deprescribing is defined by the U.S. Deprescribing Research Network as “…the thoughtful and systematic process of identifying problematic medications and either reducing the dose or stopping these medications in a manner that is safe, effective, and helps people maximize their wellness and goals of care” [1]. Deprescribing can also be indicated to reduce pill burden and increase compliance and clarity in patient medication regimens. Pill burden is more than just medication volume. Pill burden also involves various factors such as administration complexity (e.g. inject-

able, inhalation, oral, or topical), frequency of administration or how many trips a patient must make to the pharmacy in a given amount of time. Deprescribing is done by careful evaluation of all medications and their place in a patient’s therapy. Using tools such as Beers’ criteria and the IESC (Indication, Effectiveness, Safety, and Compliance/Cost) can aid health care providers including pharmacists in making sure all medications are indicated, appropriate, efficacious, and safe. Defining Polypharmacy Despite the need, polypharmacy does not have a standardized definition to use in practice and has been defined in several ways. A systematic review published in 2017, found a total of 138 definitions for polypharmacy within 110 studies [2]. One of the most common ways of defining polypharmacy is by numerical count, specifically the use of 5 or more medications daily. Other studies further stratified polypharmacy into minor, moderate, and excessive, severe, or hyperpolypharmacy according to the number of medications taken daily. Another common method incorporated in healthcare settings is to assess number of medications administered during hospital stay or at discharge. A less common method used to define polypharmacy is differentiating between appropriate and inappropriate polypharmacy. Appropriate polypharmacy is the use of multiple medications for suitable disease states such as diabetes or tuberculosis for which the prescribed medication regimens are evidence based and consider potential drug interactions and adverse drug events [3]. Inappropriate polypharmacy includes |27| www.KPHANET.org

overprescribing, (prescribing more drugs than necessary) misprescribing, and under-prescribing (lack of drug treatment for a disease for which drug therapy is indicated without any contraindications present). One study reported that 43% of â&#x2030;Ľ 65year-old patients who use 5 or more medicines are undertreated, indicating that under-prescribing is common in polypharmacy [4]. Many tools are available to assess inappropriateness versus appropriateness, one of the most widely used tools in the United States is the Beers Criteria. The Beers Criteria provides guidance for medications that are potentially inappropriate in most older adults and medications that are potentially inappropriate in older adults with certain conditions as well as drug-drug interactions and drug-disease interactions to avoid in older adults [5]. Care for each patient should be individualized and approached holistically. Each medication could be clinically relevant and prescribed in accordance with guidelines, making a numerical method futile when used alone to define polypharmacy. In addition, medications must be reviewed for indication, efficacy, and potential for harm to assess appropriateness. Drug interactions among all prescribed and nonprescribed medications need to be taken into consideration when monitoring and evaluating the safety and effectiveness of polypharmacy regimens.

to unwanted consequences such as increased incidences of hospitalizations. In an analysis of 58 emergency departments (ED) across the United States between 2013 to 2014, for approximately 4 out of 1000 patients, the primary reason to visit the ED was for an adverse drug event. Within this population, an estimated 34.5% were aged 65 years or older and from this subset, 43.6% of these ED visits ultimately resulted in hospitalization [10]. Commonly seen adverse events in hospitalized patients are related to falls, cognitive impairment, lethargy, and depression. Identifying Polypharmacy and At-Risk Population The following risk factors increase the risk of polypharmacy contributed adverse events and can help to identify patients who need polypharmacy intervention [11]:

Increasing age: The population most likely to experience polypharmacy is the older adult population, those who are 65 years of age and older. Within this population, women 85 years of age are more likely to experience inappropriate prescribing [12]. Older patients tend to be frailer, possess impaired renal and hepatic function, and reduced mobility, cognition, and vision. These factors predispose the older population for increased risk for adverse events compared to younger, healthier patients taking the same medications. Medication adverse effects vary from Polypharmacy and Health Outcomes person-to-person, but it becomes even more difficult to predict As the number of prescribed drugs increases, the patient inthe severity of these effects in older adults. Most medications curs a higher likelihood of harm and adverse events. are understudied in those 65 years and older. Many clinical Polypharmacy carries a higher risk of falls, increased length of trials apply strict inclusion criteria that tend to result in an hospital stays, higher readmission to hospitals, increased med- underrepresentation of older patients since complex medicaication errors, and mortality. In addition to the latter mention lists commonly seen in this population increases the tioned risks, drug-drug interactions and drug-disease interacchances of polypharmacy which clinical trials may not want tions also pose a large risk to this patient population. One to monitor extensively. study reported that the risk of adverse events increases by 13% with two medications, 38% with four medications, and 82% Multiple co-morbidities: with seven or more medications [6]. To further emphasize the Managing comorbidities poses an interesting polypharmacy importance for addressing polypharmacy, adverse drug events predicament. As the number of diseases increases, more mediare the fourth to sixth leading cause of death in the United cations are required to manage the co-morbid states. With States and cost the health care system between $37.6 and $50 more medications involved in the care of a patient, the greater billion per year [7]. the risk for adverse effects; therefore, more monitoring parameters are needed to ensure that medications taken concurrently Studies have shown that up to 40% of adults 65 years of age do not have antagonistic effects. and older take 5 or more medications daily [8]. When considering that 1 in 5 prescriptions are considered inappropriate [6], Multiple providers assisting in care for one patient: this shows that polypharmacy is an important issue that needs Another component that increased comorbidities presents in to be addressed within the health care community. For older polypharmacy is the increased number of physicians and spepatients, a complex and high pill burden can be confusing as cialty practices seen by the patient. With multiple health care well as overwhelming, leading to non-adherence and poor providers assisting in the care of a single patient, many times health outcomes. According to a study released in 2019, over miscommunication may result in unnecessary prescribing or half of the community-dwelling older adults involved were not discontinuing certain medications even though deemed unable to manage their medication routines on their own [9]. inappropriate. Every provider partaking in the care of one Inability to manage oneâ&#x20AC;&#x2122;s medications appropriately can lead patient must perform due diligence when evaluating the pa|28| Kentucky Pharmacists Association | May/June 2020

tient's medication record to avoid unnecessary polypharmacy. This would include making sure duplication of therapy is not present and drug-drug or drug-disease interactions are all accounted for when running drug interactions. By having each provider making a conscious effort to reconcile medication discrepancies, this will reduce the likelihood of unnecessary polypharmacy.

medications for each arising novel problem, this can result in the conundrum of inappropriate polypharmacy (Figure 1).

“Any new symptom in an older patient should be considered a possible drug side effect until proved otherwise” [14]. This old recommendation still holds true today and has the potential to prevent a prescribing cascade when health care providers keep this statement in mind while practicing. A case study Unaccounted herbal and over the counter (OTC) medicaof a 71-year-old woman presents an example of a prescribing tions: cascade. She was prescribed amlodipine for hypertension and Often overlooked, herbal medications and other OTC medica- developed lower limb edema. To treat the lower limb edema, her cardiologist prescribed furosemide and spironolactone. tions (e.g. vitamins, analgesics, sleep aid, etc.) can result in After 3 weeks, she was prescribed fesoterodine to alleviate drug-drug interactions with a patient’s prescription medicaoveractive bladder symptoms from the prescribed diuretics. tions. An example would be St. John’s Wort, an over-theThe fesoterodine caused dry mouth for which she was precounter herb that is taken for its supposed anti-depressant properties. St. John’s Wort is notoriously known for its many scribed anetholtrithion by her family physician which subsequently led to the patient falling and presenting to the emerdrug-drug interactions due to its enzyme and transporter ingency department [15]. ducing properties [13]. Since patients are able to buy OTC medications on their own, many times there is a misconcepNumerous adverse drug reactions (ADRs) often present as tion that OTC medications are benign and thus patients often geriatric syndromes, symptoms that typically occur as one feel like there is no need to disclose their use of OTC medica- ages, leading providers to not monitor for them or add a new medication to the regimen. As a pharmacist, one should contions. However, despite the relative ease of accessibility for sider whether the current ADR is caused by a drug, drug-drug obtaining OTC medications, OTC medications may lead to interaction, or drug-disease interaction when considering a harmful drug interactions when taken with other medications. patient’s symptoms. It is important to recognize when medicaKnowing about the risk factors of polypharmacy is helpful in tions are duplications of therapy, being used to treat ADRs of identifying and starting to address inappropriate polypharma- other medications, or ineffective in a patient. For any patient on medications, medication optimization is beneficial but escy. However, there is another layer of complexity that ought pecially in polypharmacy situations to reduce pill burden. to be considered. Polypharmacy is often triggered by a preOptimization can take the form of minimizing dosing frequenscribing cascade which can be described as when an adverse cy, ensuring appropriate indication, monitoring medication event of a medication is thought to be caused by a new under- effectiveness and clinical goals, and ensuring drug interactions lying problem. This unfortunately often results in a new medi- do not create unwarranted adverse events when taken concurcation being prescribed to treat this supposedly “new probrently. lem”, when in fact adjusting the current medication could Prevention of Polypharmacy alleviate the issue. With this vicious cycle of prescribing new Since polypharmacy does not have a well standardized definition, it is key to look beyond the number of medications and differentiate between appropriate and inappropriate polypharmacy. Polypharmacy may be clinically necessary to treat all underlying conditions. The risks versus benefits must be weighed for each patient. While taking multiple medications may be appropriate for specific disease states, this creates more opportunities for medication errors to occur. For example, in disease states where medications are frequently adjusted (i.e. heart failure), patients can become confused as to which medications are currently prescribed and continue to take previously prescribed medications, even if the medications may no longer be warranted. This would be a case of inappropriate polypharmacy. Preventing a mistake rather than correcting a mistake typically has better |29| www.KPHANET.org

clinical outcomes. As a pharmacist, there are several approaches that can be taken here: Medication Reconciliation:

importance of disclosing any issue they are facing with their medications. 

In addition to encouraging the disclosure of all pharmaceuticals, it is beneficial to recommend the patient carry a comprehensive drug list to all appointments and pharmacy visits. Pharmacists can play a key role in assisting patients with creating these lists and updating them regularly.



Obtain a comprehensive medication list including prescription medication, OTC medications, and herbal supplements.



Ask for any clarification and assess for appropriateness.



Since a patient may see numerous practitioners it is important to have this reconciled list of medication for the pharmacy as well as the rest of the patient’s healthcare team to close any information gaps.

Tools to Resolve Polypharmacy Once Identified

DUR is an authorized, structured, continuous review of prescribing, dispensing, and use of medication [16]. DURs can be completed in three manners, prospectively, concurrently, and retrospectively. By completing DURs, pharmacists are able to track prescribing and medication use patterns, allowing for collaboration with the provider to improve medication regimens.



Viewing each patient in a holistic manner throughout the patient care process is crucial; this is also true for resolving polypharmacy. Once inappropriate medication use has been Ongoing Review of Medications: identified in a patient experiencing polypharmacy, actions  A vital role in all pharmacy settings, including communi- should be taken to optimize therapy. As a pharmacist, there ty, ambulatory, and clinical settings. Ongoing review can are specific tools that can be utilized to resolve these incidencbe accomplished by utilizing the IESC tool or a Drug Uti- es: lization Review (DUR).  Medication Therapy Management Services 

Deprescribing

Medication Therapy Management Services provide a bridge in communication between the patient, practitioner, and payer. Documenting medication problems along with recommendations for resolution provides the physician with a larger, complete picture of the patient. In addition to providing the physician with this documentation, pharmacists are able to provide a Medication Action Plan and an updated Personal Medication Record to the patient to keep track of changes and prevent future confusion.

For example, this could prevent the addition of a second, unnecessary antihypertensive medication because it was discovered the patient has not been taking their losartan appropriately because it makes them lightheaded, causing Deprescribing a medication may be the most appropriate rectheir blood pressure to not meet goal levels. Knowing this ommendation in some cases. Deprescribing is “the process of allows the healthcare team to optimize the patient’s regiwithdrawal of an inappropriate medication, supervised by a men. health care professional with the goal of managing polypharAssessing for Medication Appropriateness: macy and improving outcomes,” [17]. Patient-centered care is always a vital part of therapy, but this is especially true in re As mentioned before, patients may be prescribed numerous medications in accordance with guidelines leading to gard to deprescribing. If patients are not on board with recompolypharmacy. Deciding whether a medication is appro- mendations and are not able to come to a mutual understanding on why and how to take medications they are prescribed, priate or inappropriate is patient based; benefits need to outweigh the risks. Are these medications well tolerated, these interventions will likely be fruitless. 



effective, and safe for this patient?

Steps to Deprescribing [18]:

Reviewing the 2019 American Geriatrics Society Beers Criteria for Potentially Inappropriate Medication Use in Older Adults can be helpful tool. These criteria provide a detailed list of medications to potentially avoid in older adults and in certain disease states.

Deciding to deprescribe – assess if the medication is responsible for current symptoms, whether harm outweighs continued benefits, and what will occur if the drug is discontinued or reduced.

Counseling: 

While interacting with patients, emphasize the importance of using only one pharmacy, the importance of disclosing all pharmaceuticals being consumed, and the

|30| Kentucky Pharmacists Association | May/June 2020



Utilize the IESC tool and Beers Criteria, if needed.



Most importantly, consider the patient’s preference, goals, and concerns when deciding to make medication changes.

Develop a plan to deprescribe 



Consider if a tapering regimen is required to minimize withdrawal effects. Consider if non-pharmacologic therapy can be used to replace current therapy.

Polypharmacy is a concern that needs to be addressed due to the following main points: Increasing number of medications are directly correlated with increased risk for adverse events such as falls, hospital stays, and mortality.

Adverse drug events are the fourth to sixth leading cause of Continue to communicate and consider patient’s preferdeath in the United States and are very well preventable situaences. Provide the deprescribing plan verbally and in writtions. ing to help mitigate confusion in patients and their careCaring for patients who are affected by adverse drug events is givers. a large cost burden on the healthcare system in the United  In addition to ensuring patient and caregiver’s underStates. An estimated $37.6 to $50 billion is spent on addressstanding of the plan, it is crucial to educate them on the ing these cases annually [5]. Resources used here on preventareason for deprescribing, what symptoms to expect during ble situations can be used elsewhere when polypharmacy is the process, what to do if they experience withdrawal managed and addressed appropriately. symptoms and who to follow-up with. Pharmacists have a vital role to play in managing polyphar Include a monitoring plan to determine all the outcomes macy. With clinical knowledge about drug interactions and of the deprescribing intervention. adverse effects, pharmacists are often the first to notice if an Implementation of the plan adverse effect is the result of a drug-drug interaction or drugdisease interaction. Pharmacists aid in medication reconcilia In order to implement, the plan must be agreed upon by tion, giving a thorough review of each medication and considthe practitioner as well as the patient. ering appropriateness based on indication, severity of side  Follow-up using the monitoring plan to measure outeffects, efficacy, and safety, as well as various other factors comes. Review the outcomes to determine whether the such as patient cognitive capacity, ease of administration, and medication can be permanently discontinued, needs a cost. Tools such as Beers Criteria or using the IESC tool as replacement medication, needs to be restarted, or needs to part of a prescribing/note taking template, can aid decisions be adjusted. on continuing, changing, or discontinuing medication regimens. As always, patient-centered care should be practiced. A handy resource is the Deprescribing App for your phone, Without a mutual agreement from the patient and their carecreated by the Bruyère Deprescribing Guidelines Research takers to agree upon a recommended deprescribing plan, all Team, allowing for quick access to their deprescribing algorithms. This app can be accessed at http://deprescribing.org. changes will be essentially useless. A plan which is understood and agreed upon by all parties leads to successful reducAn additional resource is the US Deprescribing Network which offers guidelines for deprescribing medications, education in inappropriate polypharmacy and results in improved health outcomes for the patient. tional videos and other tools to help frame decision making 

for clinicians and patients. This resource can be accessed at https://deprescribingresearch.org. Conclusion Polypharmacy is a complex and often daunting issue for health care providers to tackle. Being able to maneuver between the various moving parts to provide optimal medication regimens is both time consuming and energy expending. However, polypharmacy is an issue that should not be ignored for the sake of convenience. Patients ages 65 and older experience increased adverse effects and undesirable health outcomes, such as hospitalizations, when polypharmacy is unmonitored. With polypharmacy often being described as taking 5 or more medications daily, older patients rely on health care providers to ensure that they are receiving the appropriate medications and regimens.

References: 1. What is Deprescribing? [Internet]. US Deprescribing Research Network. [cited 2020Apr8]. Available from: https://deprescribingresearch.org/about-us/what-isdeprescribing/ 2. Masnoon, Nashwa, et al. “What Is Polypharmacy? A Systematic Review of Definitions.” BMC Geriatrics, vol. 17, no. 1, Oct. 2017, doi:10.1186/s12877-017-0621-2. 3. Cadogan, Cathal A., Cristín Ryan, and Carmel M. Hughes. "Appropriate polypharmacy and medicine safety: when many is not too many." Drug safety 39.2 (2016): 109116. 4. Kuijpers, Mascha AJ, et al. "Relationship between polypharmacy and underprescribing." British journal of clinical pharmacology 65.1 (2008): 130-133. 5. American Geriatrics Society 2019 Updated AGS Beers Criteria® for Potentially Inappropriate Medication Use in Older Adults. (2019). Journal of the American Geriatrics Society, 67(4), 674–694. doi: 10.1111/jgs.15767 6. Kouladjian L, Chen TF, Hilmer SN. First do no harm: a real need to deprescribe in older patients. Medical Journal of Australia. 2015;202(4):178–9. 7. Bain KT, Holmes HM, Beers MH, Maio V, Handler SM, Pauker SG. Discontinuing Medications: A Novel Approach for Revising the Continued on p. 37 Prescribing Stage of the Medication-Use Process.

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June 2020—Polypharmacy: How Medication Complexity Requires More Attention

1. How is polypharmacy commonly defined? A) Numerical: 5 or more prescriptions taken daily B) Healthcare setting: medications administered at hospital stay or at discharge C) Both A and B D) Appropriate versus inappropriate

7. What is the most important factor to assess when making medication changes? A) Indication B) Effectiveness C) Patient’s preference, goals, concerns D) Appropriateness (according to Beers Criteria)

2. Which of the following are reasons why polypharmacy should be a health care concern? A) Economic burden on the health care system B) Increased adverse events C) Cause non-adherence and poor health outcomes D) All of the above

8. How can a pharmacist help manage polypharmacy? A) Medication Reconciliation B) Medication Therapy Management C) Providing a Medication Action Plan and updated Personal Medication Record D) All of the above

3. Which age group is most affected by polypharmacy? A) Ages 65+ B) Ages 18-25 C) Ages 26-45 D) Ages 46- 64

9. What is the correct order of steps for a medication reconciliation? 1 - Obtain a complete medication list 2 – Provide new document to the provider 3 – Reconcile old medication list with the new list, documenting changes 4 – Ask for clarification and then evaluate for appropriateness

4. Which of the following are risk factors for polypharmacy contributed adverse events? A) Increasing age and multiple morbidities B) Multiple providers C) Unaccounted herbal medicines and OTC medications D) All of the above 5. Which is not an example of inappropriate polypharmacy? A) Taking previously prescribed medications that are no longer warranted B) Prescribing medications to treat adverse events of other medications (e.g. promethazine for lisinopril induced dry cough) C) Using multiple medications from different drug classes to treat a specific disease state (e.g. valsartan and hydrochlorothiazide to treat hypertension) D) Taking two drugs from the same drug class (e.g. temazepam for sleep and alprazolam for anxiety) 6. IESC is a tool used to assess each medication when considering deprescribing. What does IESC stand for? A) Improvement, Effectiveness, Selectivity, Concerns B) Indication, Effectiveness, Safety, and Compliance/Cost C) Improvement, Effectiveness, Selectivity, Compliance/Cost D) Indication, Effectiveness, Safety, Concerns

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A) 1, 4, 3, 2 B) 1, 2, 3. 4 C) 3, 1, 2, 4 D) 4, 3, 2, 1 10.Why is it important to develop a monitoring plan as a health care provider when dealing with polypharmacy deprescribing? A) Determine if a medication can be permanently discontinued B) Determine if a medication needs to be restarted, adjusted, or replaced C) A & B D) Determine if other health care providers are making changes that are in compliance with current recommendations

Expiration Date: 6/30/23 Successful Completion: Score of 80% will result in 1.0 contact hours TECHNICIANS ANSWER SHEET. June 2020—Polypharmacy: How Medication Complexity Requires More Attention Universal Activity # 0143-0000-20-006-H05-T Name _______________________________________________KY Cert. # __________________________________ Address ______________________________________________Email_____________________________________ PLEASE CIRCLE THE APPROPRIATE ANSWERS: 1. A B C D 2. A B C D

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Information presented in the activity:

Met my educational needs ___Yes ___No Figures and tables were useful ___Yes ___No Achieved the stated objectives ___Yes ___No Posttest was appropriate ___Yes ___No Was well written ___Yes ___No Commercial bias was present ___Yes ___No Is relevant to my practice ___Yes ___No If yes, please explain on a separate sheet. Unmet Objectives:______________________________________________________________________________ I hereby certify that I completed this self-study program independently and without assistance from any other party. Signature ____________________________________________Completion Date___________________________ Personal NABP eProfile ID #_____________________________ Birthdate _______ (MM)_______(DD)

PHARMACISTS ANSWER SHEET June 2020—Polypharmacy: How Medication Complexity Requires More Attention Universal Activity # 0143-0000-20-006-H05-P Name ________________________________________________ KY Lic. # __________________________________ Address ______________________________________________Email_____________________________________

PLEASE CIRCLE THE APPROPRIATE ANSWERS: 1. A B C D 2. A B C D

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The Kentucky Pharmacy Education & Research Foundation is accredited by The Accreditation Council for Pharmacy Education as a provider of continuing Pharmacy education. |33| www.KPHANET.org

Pharmacy Policy Issues Advancing Pharmacy Practice through Board Authorized Protocols Author: Kyle D. Bryan, Pharm.D. Issue: In December of 2017 regulation 201 KAR 2:380 was approved granting the Kentucky Board of Pharmacy the authority to establish protocols for the treatment of 13 conditions. Protocols for 9 of the 13 conditions have been approved as of the time of writing (February, 2019), with the last 4 under development. As these protocols become utilized in pharmacies across the state, clinical services provided by pharmacists will expand allowing citizens of Kentucky to have better access to health care services. Whatâ&#x20AC;&#x2122;s the difference between prescriptive authority and the Kentucky Board Authorized Protocols? Have other states given pharmacists prescriptive authority or implemented similar Board Authorized Protocols? Why is this important? Discussion: Prescriptive authority is the ability of a health care provider to prescribe federal legend drugs independently of another health care provider. This can be through legislation giving unrestricted authority to prescribe drugs, e.g., the ability of physicians to prescribe drugs, or through statewide protocols that grant prescriptive authority to a health care provider for certain conditions. Prescriptive authority has been granted to pharmacists, either through legislation or statewide protocol, in a handful of states in recent years. California, Colorado, Hawaii, Maryland, New Mexico, and Oregon have all given pharmacists the legal authority to prescribe contraceptives.1 Tobacco cessation prescriptive authority has also been granted to pharmacists in Arizona, California, Idaho, and New Mexico.1 Additional efforts are being made to expand pharmacist prescriptive authority in different states to help address common public health issues.

Access to regular health care is essential to helping patients live healthier and longer lives, decreasing hospital admissions/readmissions, and ensuring proper maintenance of chronic disease states. Unfortunately, throughout much of the country, access to health care is limited and there is an increasing demand for primary healthcare providers. This demand is only going to rise as the number of patients living with chronic disease states continues to increase. In fact, by 2025 the Health Resources and Services Administration (HRSA) estimates that there will be a 30% shortcoming in primary care provider in Kentucky.2 In fact, the HRSA already classifies 95 of the 120 counties in Kentucky as medically underserved areas having too few primary care providers.3,4 This shortfall of primary care providers creates a demand that pharmacists are more than capable of helping to meet. Pharmacists are well recognized as the most accessible health care provider with patients often living within close to more than one pharmacy. Additionally, pharmacists are well qualified and trained, through a rigorous education and years of experience, to provide expanded services. Through the advancement of pharmacy practice, pharmacists can help fulfill the needs being created by an aging population and an increase in need for chronic disease management. Board authorized protocols are one such way for this advancement to occur. Board authorized protocols will allow for prescribers and pharmacists to work together to help meet the health care needs of their community by increasing access to services and helping decrease patient burden for prescribers.

References: The Board Authorized Protocols in Kentucky differ from prescriptive authority in that pharmacists have not been 1. NASPA State Policy Resources. 9 November 2018. granted prescriptive authority but rather are providing serAvailable at: https://naspa.us/resource/swp/#uniquevices and initiating the dispensing of medications pursuant to identifier-category written agreement with a prescriber. The Board Authorized Protocols are a type of population specific collaborative prac- 2. Pharmacistsâ&#x20AC;&#x2122; Authority to Deliver Protocol-Driven Care Set to Impact Patient and Public Health Across Kentice agreement wherein prescribing authority remains with tucky. 1 May 2018. Available at: http:// the licensed prescriber, and the pharmacist is only initiating pharmacy.uky.edu/news/pharmacists%E2%80%99the dispensing of medications under a strict set of conditions. authority-deliver-protocol-driven-care-set-impact-patientSuch collaborative practice agreement protocols are common and-public-health-across throughout the country to help address the healthcare needs of citizens. Continued on p. 37 |34| Kentucky Pharmacists Association | May/June 2020

Welcome to KPhA! Weâ&#x20AC;&#x2122;re so happy to have you! The list reflects new memberships received from March 1, 2020â&#x20AC;&#x201D; April 30, 2020. Thea Browning, Louisville Pharmacist Member Kari Edwards, Madisonville Pharmacist Member Felix Gyamfil, Louisville Pharmacist Member Tracy McWhirter, Louisville Pharmacist Member Meleigha Milby, Campbellsville Pharmacist Member

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Pharmacy Law Brief Something Pharmacists Do Every Day that Saves Author: Joseph L. Fink III, BSPharm., JD, DSc (Hon), FAPhA, Professor of Pharmacy Law and Policy and Kentucky Pharmacists Association Professor of Leadership, Department of Pharmacy Practice and Science, UK College of Pharmacy Question: A pharmacy student was doing a rotation with me and we got talking about child-resistant packaging for prescription medications. Realizing how old I am, she asked me about pharmacy practice during the days before childresistant caps were required. Her question about had I ever encountered a situation where such closures would have prevented an incident took me back to a situation in the late 60’s. A child got into a medication container that had a standard cap. Fortunately, that breach was discovered right away by a parent and a horrible outcome was avoided. I was contacted by the parents as they worked to assure that none of the dosage units were unaccounted for. That led me to becoming a strong advocate for the safety closure mandate. Can you provide some background about the law in this area?

Disclaimer: The information in this column is intended for educational use and to stimulate professional discussion among colleagues. It should not be construed as legal advice. There is no way such a brief discussion of an issue or topic for educational or discussion purposes can adequately and fully address the multifaceted and often complex issues that arise in the course of professional practice. It is always the best advice for a pharmacist to seek counsel from an attorney who can become thoroughly familiar with the intricacies of a specific situation, and render advice in accordance with the full information.

Commission (CPSC), an agency pharmacists may not deal with often. Most people hear about the activities of the CPSC when dangerous toys or baby cribs are withdrawn from the market.

The legal standard for safety caps is that the patient may issue a “blanket” request that all prescriptions be dispensed with standard caps. This would be appropriate in a situation where Response: The Poison Prevention Packaging Act (PPPA) the patient has difficulty opening such caps due to an arthritic was enacted during 1970 after several years of discussion and condition or otherwise. When discussing that decision with a a variety of attempts by government agencies and others to patient the pharmacist would be well advised to reinforce stem the tide of poisonings. One change that foreshadowed with the patient the importance of keeping the medication enactment of the PPPA was the limiting of the capacity of out of reach of children. And related to the issue of requestbottles of children’s aspirin to 36 tablets, generally less than a ing use of a standard cap, it is noteworthy that a prescriber lethal dose. does not have authority to make such a “blanket” request; prescribers must do it on a prescription-by-prescription basis. How is it determined that a closure is child-resistant? It is a When accepting a waiver from a patient it is a best recomthree-pronged standard: mendation to have that memorialized in writing. This apThe container is given to 200 children age five and under proach is recommended despite the fact that neither the statwho have five minutes to try to gain access to the contents. ute or CPSC’s regulations on this topic mandate getting that When that time has expired those who have not been sucin writing. cessful in opening it are given a demonstration of how it Several interesting issues have arisen since the statute was works with an additional five minutes to try. Third, the closure is given to 100 adults who have five minutes to attempt enacted and the standards put in place. The first relates to the widely adopted palm-and-turn design for these caps. The to open it after reading instructions. CPSC has concluded that this design may “weaken” with To be considered child-resistant (emphasis – these are not repeated use, thereby compromising the desired childchild-proof as many are wont to say) the cap must have kept resistance. Consequently, the CPSC directs that such caps are at least 85% of the first group of kids out, as well as at least not to be used on the container when a refill is dispensed; 80% of the kids after the demonstration of how it works. Firather, a new closure or entire container should be provided nally, the group of adults must have had at least 90% of them to maximize protection of children. succeed in opening it. Note that it this last standard that can lead to frustration – up to ten percent of adults can be defeat- What about those reversible caps where one unit can either ed when attempting to open the lid! If all three standards are be used in a child-resistant configuration or flipped over to be non-resistant. If such a cap were provided and a child gained met the closure will meet governmental standards for childaccess to the medication how would the pharmacist defend resistance. the resultant lawsuit. The pharmacist could go to court to This statute is administered by the Consumer Product Safety |36| Kentucky Pharmacists Association | May/June 2020

testify that the reversible closures are always placed in the child-resistant configuration at the time of dispensing. It would also be wise to have in the pharmacy’s policies and procedures document a statement that the child-resistant approach is how the medication is to leave the pharmacy. There have been lawsuits against pharmacists related to child-resistant packaging issues.1 How effective has the statute been? One study published in Pediatrics reported that “the ingestion rate for all substances that require child-resistant closures declined from 5.7/100,000 children in 1973 to 3.4/100,000 children in 1978. It was estimated that child-resistant closures had prevented nearly 200,000 accidental ingestions between 1973 and 1978. Focusing on a longer period of time (20 years) the author pointed to the death rate from poisonings of children declined from 2.0/100,000 to 0.5/100,000.2 All community practitioners have heard complaints from patients who have encountered difficulty when opening the protective caps. Those conversations should be viewed as an opportunity to educate patients about the importance of this packaging requirement and the documented effectiveness of the rules. The interaction between preceptor and student pharmacist that prompted this question focuses our attention once again on the fact that we benefit in many ways by having these aspiring pharmacists do rotations with us. References: 1.

Fink III JL. Liability concerns with child-resistant safety closures. U.S. Pharm. 1988(Feb);13:42-45.

Walton WW. An evaluation of the Poison Prevention Packaging Act. Pediatrics 1982(Mar); 69:363-370.

Continued From Pg. 31

Continued From Pg. 34

Journal of the American Geriatrics Society. 2008;56(10):1946–52.

Pharmacists Provide Care: Kentucky State Facts. 2018. Available at: https://pharmacistsprovidecare.com/ node/836423

Explore Data and Maps on HRSA’s Health Care Programs. Available at: data.HRSA.gov

8. Kantor ED, Rehm CD, Haas JS, et al. Trends in prescription drug use among adults in the United States from 1999-2012. JAMA. 2015;314(17):1818–1831. doi: 10.1001/jama.2015.13766. 9. Somerville, E., Massey, K., Keglovits, M., Vouri, S., Hu, Y.-L., Carr, D., & Stark, S. (2019). Scoring, Clinical Utility, and Psychometric Properties of the In-Home Medication Management Performance Evaluation (HOME–Rx). American Journal of Occupational Therapy, 73(2). doi: 10.5014/ajot.2019.029793 10. Shehab N, Lovegrove MC, Geller AI, Rose KO, Weidle NJ, Budnitz DS. US Emergency Department Visits for Outpatient Adverse Drug Events, 2013-2014. Jama. 2016;316(20):2115. 11. Cifu DX, Lew HL, Oh-Park M, Parulekar MS, Rogers CK. Chapter 9: Polypharmacy and Mobility. In: Geriatric rehabilitation. St. Louis: Elsevier; 2018. p. 121–3. 12. Morgan, S. G., et al. “Frequency and Cost of Potentially Inappropriate Prescribing for Older Adults: A Cross-Sectional Study.” CMAJ Open, vol. 4, no. 2, 2016, doi:10.9778/cmajo.20150131. 13. Mannel M. Drug interactions with St John’s wort. Drug safety. 2004 Sep 1;27(11):773-97. 14. Avorn J, Shrank WH. A substantial cause of preventable illness. BMJ. 2008Aug;336(7650).doi: 10.1136/bmj.39520.671053.94. 15. Nguyen, Patrick Viet-Quoc, and Caroline Spinelli. "Prescribing cascade in an elderly woman." Canadian Pharmacists Journal/Revue des Pharmaciens du Canada 149.3 (2016): 122-124. 16. Kubacka, R. T. (1996). A Primer on Drug Utilization Review. Journal of the American Pharmaceutical Association (1996), 36(4), 257–262. doi: 10.1016/s10865802(16)30049-3 17. Reeve E, Gnjidic D, Long J, et al. A systematic review of the emerging definition of 'deprescribing' with network analysis: implications for future research and clinical practice. Br J Clin Pharmacol. 2015;80(6):1254–1268. doi: 10.1111/bcp.12732. 18. Polypharmacy and Deprescribing [Internet]. Bruyere Continuing Care; [cited 2020Apr10]. Available from: https://www.bruyere.org/patientsafetymodules/Deprescribing/story_html5.html

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Financial Forum The Major Retirement Planning Mistakes

This series, Financial Forum, is presented by PRISM Wealth Advisors, LLC and your State Pharmacy Association through Pharmacy Marketing Group, Inc., a company dedicated to providing quality products and services to the pharmacy community.

Much is out there about the classic financial mistakes that plague start-ups, family businesses, corporations, and charities. Aside from these blunders, some classic financial missteps plague retirees. Calling them “mistakes” may be a bit harsh, as not all of them represent errors in judgment. Yet whether they result from ignorance or fate, we need to be aware of them as we plan for and enter retirement. Leaving work too early. As Social Security benefits rise about 8% for every year you delay receiving them, waiting a few years to apply for benefits can position you for higher retirement income. Filing for your monthly benefits before you reach Social Security’s Full Retirement Age (FRA) can mean comparatively smaller monthly payments. Meanwhile, if you can delay claiming Social Security, that positions you for more significant monthly benefits.1 Underestimating medical bills. In its latest estimate of retiree health care costs, the Center for Retirement Research at Boston College says that the average retiree will need at least $4,300 per year to pay for future health care costs. Medicare will not pay for everything. That $4,300 represents out-ofpocket costs, which includes dental, vision, and long-term care.2 Taking the potential for longevity too lightly. Actuaries at the Social Security Administration project that around a third of today’s 65-year-olds will live to age 90, with about one in seven living 95 years or longer. The prospect of a 20- or 30year retirement is not unreasonable, yet there is still a lingering cultural assumption that our retirements might duplicate the relatively brief ones of our parents.3 Withdrawing too much each year. You may have heard of the “4% rule,” a guideline stating that you should take out only about 4% of your retirement savings annually. Many cautious retirees try to abide by it. So, why do others withdraw 7% or 8% a year? In the first phase of retirement, people tend to live it up; more free time naturally promotes new ventures and adventures and an inclination to live a bit more lavishly. Ignoring tax efficiency & fees. It can be a good idea to have both taxable and tax-advantaged accounts in retirement. Assuming your retirement will be long, you may want to assign this or that investment to its “preferred domain.” What does that mean? It means the taxable or tax-advantaged account that may be most appropriate for it as you pursue a better after-tax return for the whole portfolio. Many younger investors chase the return. Some retirees, however, find a shortfall when they try to live on portfolio income. In response, they move money into stocks offering significant dividends or high-yield bonds – something you might regret in the long run. Taking retirement income off both the principal and in|38| Kentucky Pharmacists Association | May/June 2020

terest of a portfolio may give you a way to reduce ordinary income and income taxes. Avoiding market risk. Equity investment does invite risk, but the reward may be worth it. In contrast, many fixed-rate investments offer comparatively small yields these days. Retiring with heavier debts. It is hard to preserve (or accumulate) wealth when you are handing portions of it to creditors. Putting college costs before retirement costs. There is no “financial aid” program for retirement. There are no “retirement loans.” Your children have their whole financial lives ahead of them. Try to refrain from touching your home equity or your IRA to pay for their education expenses. Retiring with no plan or investment strategy. An unplanned retirement may bring terrible financial surprises; the absence of a strategy can leave people prone to market timing and day trading. These are some of the classic retirement planning mistakes. Why not plan to avoid them? Take a little time to review and refine your retirement strategy in the company of the financial professional you know and trust.

Rx and the Law Social Media and HIPPA This series, Pharmacy and the Law, is presented by Pharmacists Mutual Insurance Company and your State Pharmacy Association through Pharmacy Marketing Group, Inc., a company dedicated to providing quality products and services to the pharmacy community. Recently a dentist reached a resolution agreement with the Office of Civil Rights (OCR) in the Department of Health and Human Services (HHS) for a complaint regarding a violation of the Health Insurance Portability and Affordability Act (HIPAA). While this example occurred in a dental office, the lessons are equally applicable to pharmacies. Patient Joan had filed a complaint with OCR alleging Dr. Smith's dental practice had impermissibly disclosed her protected health information (PHI) on YelpÂŽ. While we do not have access to verbatim quotes, it is not difficult to infer what happened. Jane had left a review of Dr. Smith's practice and her experience during her last visit. Presumably it was not a positive review and in response, Dr. Smith's office included her last name, details of her treatment plan, and insurance and cost information for her treatment in their response to her review. While this information might be useful to defend yourself against a negative review, HIPAA prohibits the disclosure of such information except in certain situations. In response to the disclosures, Jane filed her complaint with OCR. During the OCR's investigation, it was discovered that Dr. Smith's office had disclosed similar information in a number of responses to other patients' reviews. To resolve the matter, Dr. Smith's office agreed to a Corrective Action Plan and paid HHS $10,000. Social Media can be a great way to increase a pharmacy's visibility and promote the many goods and services it provides. The trap for the unwary is the ease at which messages can be created and posted. The utility of personal devices today makes it very easy to take a picture and post it with a caption in seconds. In this case, the dentist disclosed PHI in response to a negative review. While we might all say we would not do something like that, the ease of posting on social media can cause us to quickly do something without fully thinking it through. If, for example, you wanted to post a picture of one of your staff members, it is easy to take a quick picture. You are focused on your staff member and whether they blinked or their smile looks good. You may not notice that there is a patient in the background, or a computer screen that legibly shows a patient's profile, or the staff member is holding a prescription with the patient's name and medication clearly visible. Any of these situations would be a HIPAA violation. Similarly, even taking pictures of your facility for your website might disclose PHI if the photos are not carefully staged and edited. You should also have a policy for your staff regarding photos in the pharmacy and posting to social media. Pictures from someone's birthday party that inadvertently disclose PHI could be posted on an employee's Facebook page. The employee is thinking about fun and focusing on the celebration,

not the counseling session going on in the background. The same temptations for a quick and easy post exist for your patients also. You and you staff should be alert for patients, or even just persons loitering, who are using their phone to take pictures or video in the dispensing or counseling area. These people are giving much less conscious thought to protecting PHI than your staff. Your diligence in protecting privacy will be beneficial in your defense when an errant posting slips through. What should you do in the event that PHI is posted on social media, whether it is by pharmacy staff, patients, or someone else? If a posting was made by the pharmacy staff, it should be taken down as soon as possible. Documentation of how the incident occurred and your corrective actions should be made. A patient can disclose their own PHI to whomever they choose, but they cannot disclose someone else's PHI. Disclosure of someone else's PHI by either a patient or a third party necessitates a call to the poster asking them to remove the PHI. It would be wise to advise a patient that disclosing their PHI to the world is probably not a good choice. Thorough investigation and documentation of all incidents should be made and retained. You will need to consult state and Federal requirements to determine who, if anyone, is required to be notified of the incident. Social media is a great tool to market and promote the services of your pharmacy. As with any tool, careful consideration of how it is used is crucial. Bad publicity from disclosing PHI on social media could be crushing to your practice. Use social media wisely and it is worth its weight in gold.

Kentucky Professionals Recovery Network (KYPRN) is a free-standing organization that provides confidential monitoring of licensed professionals struggling with the disease of addiction.

www.kyprn.com |39| www.KPHANET.org

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KPhA BOARD OF DIRECTORS

*At-Large Member to Executive Committee

Chris Palutis, Lexington chris@candcrx.com

Chair

KPERF BOARD OF DIRECTORS

Don Kupper, Louisville donku.ulh@gmail.com

President

Bob Oakley, Louisville rsoakley21@gmail.com

Chair

Joel Thornbury, Pikeville jthorn6@gmail.com

President-Elect

Clark Kebodeaux, Lexington clark.kebodeaux@uky.edu

Secretary

Brooke Hudspeth, Lexington brooke.hudspeth@kroger.com

Secretary

Chris Killmeier, Louisville cdkillmeier@hotmail.com

Treasurer

Chris Killmeier, Louisville cdkillmeier@hotmail.com

Treasurer

Don Kupper, Louisville donku.ulh@gmail.com

President, KPhA

Chris Harlow, Louisville cpharlow@gmail.com

Past President Representative

Kevin Lamping, Lexington kevin.lamping@twc.com Paul Easley, Louisville rpeasley@bellsouth.net

Directors Angela Brunemann, Union Angbrunie@gmail.com

Sarah Lawrence, Louisville slawrence@sullivan.edu

Matt Carrico, Louisville matt@boonevilledrugs.com

Pat Mattingly, Lebanon pat@patspharmacy.com

Jessika Chilton, Beaver Dam jessikachilton@ymail.com Scotty Reams, London scotty.reams@uky.edu

University of Kentucky Student Representative

Chad Corum, Manchester pharmdky21@gmail.com

Mark Glasper Executive Director mglasper@kphanet.org Sarah Franklin Director of Communications & Continuing Education sarah@kphanet.org

Cathy Hanna, Lexington channa@apscnet.com Cassy Hobbs, Louisville cbeyerle01@gmail.com Anthony Seo, Louisville jseo0516@my.sullivan.edu

KPhA Staff

Sullivan University Student Representative

Jeff Mills, Louisville jeff.mills@nortonhealthcare.org Richard Slone, Hindman richardkslone@msn.com Ben Mudd, Lebanon* Speaker of the House bpmu222@gmail.com Martika Martin, Somerset Vice Speaker of the House 12marmar@gmail.com Misty Stutz, Crestwood mstutz@sullivan.edu |42| Kentucky Pharmacists Association | May/June 2020

Angela Gibson Director of Finance & Administrative Services agibson@kphanet.org Jody Jaggers, PharmD Director of Public Health jjaggers@kphanet.org Kristen Blankenbecler, PharmD Director of Clinical Outreach kristen@kphanet.org Michele Pinkston, PharmD, BCGP Director of Emergency Preparedness michele@kphanet.org Lisa Atha Office Assistant/Member Services Coordinator latha@kphanet.org

“More and more, the modern pharmacist’s most important service to society depends less on what he does and more on what he knows.” - From The Kentucky Pharmacist, Mary 1970 Volume XXXIII, Number 5

Frequently Called and Contacted Kentucky Board of Pharmacy

Kentucky Regional Poison Center

State Office Building Annex, Ste. 300

(800) 222-1222

125 Holmes Street

American Pharmacists Association (APhA)

Frankfort, KY 40601

2215 Constitution Avenue NW

(502) 564-7910

Washington, DC 20037-2985

www.pharmacy.ky.gov

(800) 237-2742

Pharmacy Technician Certification Board (PTCB)

www.aphanet.org

2215 Constitution Avenue

National Community Pharmacists Association (NCPA)

Washington, DC 20037-2985

100 Daingerfield Road

(800) 363-8012

Alexandria, VA 22314

www.ptcb.org

(703) 683-8200 www.ncpanet.org

Kentucky Society of Health-System Pharmacists

National Association of Chain Drug Stores (NACDS) 1776 Wilson Blvd., Suite 200 Arlington, VA 22209 www.nacds.org 703-549-3001

info@ncpanet.org

P.O. Box 4961 Louisville, KY 40204 (502) 456-1851 x2 www.kshp.org info@kshp.org

KPhA/KPERF HEADQUARTERS 96 C Michael Davenport Blvd. Frankfort, KY 40601 502.227.2303 (Phone) 502.227.2258 (Fax) info@kphanet.org www.kphanet.org www.facebook.com/KyPharmAssoc www.twitter.com/KyPharmAssoc www.youtube.com/KyPharmAssoc |43| www.KPHANET.org

THE

Kentucky PHARMACIST 96 C Michael Davenport Blvd. Frankfort, KY 40601