arizona journal of pharmacy Spring 2017
a z p arizona pharmacy a association
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advancing together towards the future of pharmacy
Annual Convention June 8-11, 2017
The official publication of the Arizona Pharmacy Association brought to you by the Pharmacy Network of Arizona
TABLE OF CONTENTS PAGE NUMBER 3
Board of Directors/ Editorial Board
4
President’s Message
5
Association News
8
PAPA Message
11
Legislative Update
13 15
Featured Highlights: Provider Status Updates Annual Convention Informational
21
Pharmacy Comics
23
Continuing Education: Use of Colony-Stimulating Factors in Established Febrile Neutropenia One Small Step for Man, a Giant Leap in Heart Failure Management: A Therapeutic Update on Heart Failure
Arizona Journal
Pharmacy
of
THE OFFICIAL PUBLICATION OF THE ARIZONA PHARMACY ASSOCIATION BROUGHT TO YOU BY THE PHARMACY NETWORK OF ARIZONA
Spring 2017
Vol. 8, No. 2
2016 - 2017 Board of Directors Officers Betty Louton Past President
Keith Boesen President-Elect
Lorri Walmsley President
Lisa Tonrey Treasurer
Az-ACCP CHAPTER Stacey Hollen, Chair Community Pharmacy Academy Sophia Galloway, Chair Susana Horst, Chair-Elect Health-System Academy Nicole Murdock, Chair Jeannie Hong, Chair-Elect Managed Care Academy Darren Clonts, Chair James Montague, Chair-Elect Student Pharmacist Academy Lacey Simpson, Chair, MWU Seth Anderson, Chair, U of A Brian Seigfried, Chair-Elect, MWU Candice Eastman, Chair-Elect, U of A Technician Academy Kayla Berry, Chair J.R. Gill, Chair-Elect District Directors Laura Moore, Northeast Lynette Wasson, Northwest Jacob Schwarz, Southwest
Jessica DiLeo Secretary
Industry Representative Lori Drea Dean of Colleges Phil Scheinder, The University of Arizona - Phoenix Mitch Emerson, Midwestern University - Glendale Rick G Schnellmann, University of Arizona - Tucson Legal Counsel Roger Morris, Quarles & Brady SPECIAL PROJECTS Katherine Murphy, Chair AzPA Staff Kelly Fine, Chief Executive Officer Cindy Younger, Accounting Deborah Marcum, PAPA Sarah Elenes, Membership Erin Roy, Legislative/Research Liaison Cindy Esquer, Operations Kathy Harty, Continuing Education
The interactive digital version of the Arizona Journal of Pharmacy is available for members only online at www.azpharmacy.org/ajp (480) 838-3385
web@azpharmacy.org EDITOR’S NOTE: Any personal opinions expressed in this magazine are not necessarily those held by the Arizona Pharmacy Association. “Arizona Journal of Pharmacy” (ISSN 1949-0941) is published quarterly by the Pharmacy Network of Arizona at: 1845 E. Southern Avenue, Tempe, AZ 85282-5831.
Editor Kelly Fine, R.Ph., FAzPA Chief Executive Officer
Managing Editor Cindy Esquer
Editorial Board Lindsay Davis, Pharm.D. Whitney Rice, Pharm.D. Andrea Burns, Pharm.D. Christi Jen, Pharm.D. Kalani Anderson, C.Ph.T. Nicole Scovis, Pharm.D.
Spring 2017 • Arizona Journal of Pharmacy • 3
PRESIDENT’S MESSAGE Dear AzPA Members,
Spring is upon us, Arizona is full of life and the desert is in full bloom awakening from our mild winter.
In keeping with the season, your Board of Directors are hard at work focusing on renewing and growing the Arizona Pharmacy Association. This work began nearly a year ago at our annual convention, where we asked for your feedback on how we could improve the organization. Following the annual convention we held our board retreat where the board worked to brainstorm ideas based on this feedback. We focused on several areas we felt are important in growing the association and maintaining it’s relevance; creation of a new membership for corporate partners, evaluating the needs of our new practitioners, technology and its place within the association and evaluation of our events and education. I am happy to announce that we have finalized our corporate membership and will be out actively marketing it to the business leaders in pharmacy across Arizona. If you are interested in learning more about this new type of membership, please contact kelly@azpharmacy.org. At the upcoming annual convention in June, we again will ask for your feedback via focus groups on various topics; these include membership, marketing/social media, technology and website design, education, and events. I would encourage each of you to participate in some of these sessions to ensure that your ideas are incorporated as we continue to advance together, towards the future of pharmacy in Arizona. Speaking of advancement, AZPA’s scope bill SB1269 was just recently signed by the Governor. This bill will allow pharmacists to prescribe nicotine replacement products for patients, prescribe and administer oral fluoride varnish, and authorize up to a 14 day supply of a chronic prescription if the prescriber is unreachable. This is another great example of how your association is working to advance the practice of pharmacy and serve the patients in Arizona. As my tenure as your President comes to a close, I would like to thank each of you for the faith that you have placed in me as your leader. It has been my true pleasure to serve this association and each of our members. I am immensely proud of our profession and the work that this association does to advance it. While I am sad that my term is coming to an end, you will be in great hands with your new leader, Keith Boesen. Keith is equally passionate about advancing the practice of pharmacy in Arizona, but I am sure that you would have guessed by the theme of this year’s convention, Advancing Together, Towards the Future of Pharmacy. I will leave you with one final thought, being involved does matter and your voice is important to the future our our profession. In the words of President Barack Obama, “Don’t just get involved. Fight for your seat at the table. Better yet, fight for a seat at the head of the table.”
Lorri Walmsley, RPh AzPA President 2016-2017 Spring 2017 • Arizona Journal of Pharmacy • 4
ASSOCIATION NEWS MISSION STATEMENT
The Arizona Pharmacy Association is committed to serving and representing all practice settings. AzPA will foster safe and effective medication therapy, promote innovative practice, and empower its members to serve the health care needs of the public. VISION Empowering pharmacy professionals to provide optimal patient care.
AzPA
Advancing Pharmacy to Improve Healthcare
WELCOME NEW MEMBERS
STUDENTS
ASSOCIATES
Cyndi Black Rylee Stevensen
NEW PRACTITIONERS Easa Dalaly Hyungjun Jeon George Yeh Christine Breite Dana Wilson Kenya Destin Trevor Aller
Amalia Gist Christian Hagan Mayra Guzman-Lopez Daniel St. Germain Kathy Khuu Tanner Bucholz
TECH IN TRAINING Mariana Hernandez
PHARMACISTS
Kathryn From Joan Alvarez NEW MEMBERS: Visit your Daniel Lucas Member Center to learn how to Bina Patel get more involved with AzPA. Marianne Tysoe Located on Michael Brady www.azpharmacy.org William Stanley homepage. Karen Eisenbiegler
CHEERS FOR VOLUNTEERS! We acknowledge the contributions of the volunteers who have made a difference for our organization over the past quarter. Thank you for your continued support of the pharmacy profession. Candice Eastman Stephanie Sparks
Ariane Guthrie James Montague
Rianne Michael Anissa Marzuki
Spring 2017 • Arizona Journal of Pharmacy • 5
AzPA Member Wins AACP Master Preceptor Recognition The Arizona Pharmacy Association wants to extend congratulations to Carl Labbe on winning the AACP Master Preceptor Recognition. The purpose of the American Association of Colleges of Pharmacy (AACP) Master Preceptor Recognition Program (MPRP) is to recognize preceptors who are not full-time employees of a school/college of pharmacy for their sustained commitment to excellence in experiential education and professional practice.
Golf With Us. AzPF Law on the Links At the Annual Convention June 8, 2017
1.5 Hrs Law CE
AzPA
Career Center Check out the AzPA Career Center online. Find the best pharmacy-related jobs in the state, or search through resumes of the most highly qualified pharmacists Arizona has to offer. Ask about our employer advertising.
azpa.webscribble.com
AzPA MENTOR CONNECTION PROGRAM Build relationships, further professional networks, and strengthen continuous professional development! Participation is open to all members. Program runs from October - July, annually! VISIT azpharmacy.org/mentor
Save The Date AzPA 2017 Events annual convention
June 8 - 11, 2017 (Tucson) Southwestern States Residency Conference June 9, 2017 (Tucson) Fall Conference September 16, 2017 (Scottsdale) AzPF Masquerade Ball September 30, 2017 (Chandler)
Certificate Programs AzPA Immunization Delivery Training Program June 8, 2017 (Tucson) AzPA Psychiatric June 8, 2017 (Tucson)
YOU’RE INVITED
Join an AzPA Committee
Legislative Committee Co-Chairs : Mark Boesen & Ken Bykowski Membership Committee Co-Chairs : Amy Leung & Kristyn Straw-Wilson Continuing Education Committee Co-Chairs : Nicole Scovis & Lindsay Davis Marketing/Social Media Committee Co-Chairs : Whitney Rice & Kate Murphy
VISIT
azpharmacy.org/committees
APhA Delivering Medication Therapy Management Services June 8, 2017 (Tucson)
Spring 2017 • Arizona Journal of Pharmacy • 7
PHARMACISTS ASSISTING PHARMACISTS OF ARIZONA
I
(PAPA) A Third Chance
am an Arizona pharmacist and recovering addict. My name is Jeff H. and as I write this letter, I am approaching eleven years of sobriety. After graduating college, I knew I had a substance abuse problem. Just like figuring out how to effectively pass college courses, I believed I could figure out how to manage my drinking and drug use. Control worked to some extent for the first two years, but eventually I began to experiment with prescription medications. Experimentation then led to stealing medications from the pharmacies I worked for. In 1999 I was terminated from my position with a chain drug store and reported to the board for diverting controlled substances. I begrudgingly agreed to a five-year probationary contract, during which time I appeared to be compliant. The reality was, however, that I only became exceedingly more sneaky and dishonest. One description of an addict is that we are obsessed with the controlling and enjoyment of our drug of choice despite negative consequences, and this was me. After five years, and completing my contract, I spent eighteen months engaging in progressive and destructive using behaviors. By the Spring of 2006, I was once again terminated from my position, and my license was revoked. I had, by this time, gotten married and had two young children whom I loved dearly. I very clearly remember, and shall never forget, the look of sadness and despair in my wife’s eyes when she learned of what had happened at my job. Much of the time we spent together up to that point had often been filled with distrust, suspicion, and fear because of my addictive behavior. I can also recall the weight of guilt and shame, particularly Spring 2017 • Arizona Journal of Pharmacy • 8
when I looked into my children’s faces. I asked myself how I was going to provide for them. And I worried whether or not I would even be around to see them grow up. It was a very dark time in my life, yet from this time, sprang a certain kind of hope. During my first probationary contract, I had been exposed to the programs of Alcoholics Anonymous and Narcotics Anonymous. At that time, I had not taken any of their suggestions to heart. I had refused to see myself as having the same problem they did. But with that whisper of hope inside me, I developed a true desperation to live. It was then that I made a decision to return to the meetings and find a genuine sponsor who would agree to work with
If you or someone you care about is suffering from an alcohol and/or chemical dependency problem... ...help is available. Pharmacists Assisting Pharmacists of Arizona “A Partnership in Caring”
Contact the AzPA Office at 480.207.7869 or papa@azpharmacy.org All calls confidential. Caller remains anonymous. PAPA is a program of the Arizona Pharmacy Foundation
me on my recovery. I shall never forget Peter C. who did agree to work with me and guide me through the twelve steps of Alcoholics Anonymous. He was very clear that his sole motivation in doing so was to stay sober himself, and that all the work necessary to succeed would be entirely my responsibility. He would not track me down or chase me around. Nor would he call to verify that I was doing the work. It was up to me. Every week for two years I consistently arrived at his home office, eager to present and review my assignments. I attended daily AA and NA meetings as well, with a desire to hear the experiences of others and to share my own experience of struggling with addiction. As my life began to heal, friendships developed with a lot of those people, as well as my sponsor. I chaired many meetings and continue to do so to this day. I was available to go on calls to
assist people in crisis who were reaching out for help. And in 2012, I completed a six and one half year PAPA (Pharmacist Assisting Pharmacist Association) contract and my license was restored. Today, I continue my involvement in AA and NA, having sponsored over one hundred men so far. Like my sponsor, I do not work with others for any form of recognition, but to merely inspire and maintain my own sobriety for another day. If you are a pharmacist or an individual who recognizes having difficulty with any type of drug or alcohol use, I invite you to contact the Arizona Pharmacy Foundation to speak with their staff. They have my contact information and they are available to help point you in the right direction. Thank you, Jeff H.
“I’M ALWAYS WATCHING OUT FOR MY PATIENTS, BUT WHO’S WATCHING OUT FOR ME?”
WE ARE. We are the Alliance for Patient Medication Safety (APMS), a federally listed Patient Safety Organization. Our Pharmacy Quality Commitment (PQC) program helps you implement and maintain a continuous quality improvement program that offers strong federal protection for your patient safety data and your quality improvement work. PQC also helps you comply with quality assurance requirements found in network contracts, Medicare Part D, and state regulations. We offer flexible and powerful tools, ongoing training and support to keep your pharmacy running efficiently, and most importantly, to keep your patients safe.
Call toll free (866) 365-7472 or visit www.pqc.net PQC IS BROUGHT TO YOU BY YOUR STATE PHARMACY ASSOCIATION
Spring 2017 • Arizona Journal of Pharmacy • 9
In Memoriam
The staff at the Arizona Pharmacy Association would like to express our condolences to the family and friends of Don Campbell who passed away on April 10, 2017. He had a distinguished sales career for 36 years with Eli Lilly and Company in Tucson. Don was always professional and supported teaching and the professional organizations. On two occasions, Don was awarded the Pharmaceutical Representative of the Year by AzSHP. He will be missed.
On-Demand Learning. PTCB Exam Prep Course Everything you need to know. www.azpharmacy.org
Spring 2017 • Arizona Journal of Pharmacy • 10
LEGISLATIVE UPDATE Past Legislative Wins Medication Synchronization
SB1288 is now in effect in AZ as of January 1st! This bill mandates that prescription plans issued or renewed on or after January 1, 2017 allow medication synchronization services. It states that plans may not deny coverage and are required to prorate the cost sharing rate for a prescription drug that is dispensed by a network if certain criteria are met and if the insured requests enrollment into a medical synchronization program. In addition, requires acceptance of early and short refill requests for prescription drugs using the submission clarification and message codes as adopted by NCPDP. Refer to ARS 20-848 for more details.
Fair Audit Pricing
HB2692 is now in effect in AZ as of January 1st! Arizona joins over 30 other states that have passed similar legislation to create standards for pharmacy audits. This bill creates, among other things: written notice requirements; establishes a periods of time such audits can go back in time; prohibits extrapolation and create an appeals process. Refer to ARS 20-3321 for more details.
2017 Legislative Wins SB1269-Scope Expansion: Tobacco Cessation Allows Arizona pharmacists the ability to prescribe over the counter nicotine replacement products as well as presciption nicotine replacements products indicated to aid in smoking cessation treatment for eligible patients 18 and older, according to FDA recommendations and clinical guidelines. Signed by the Governor on March 29th.
SB1269-Scope Expansion: Emergency Refills Allows Arizona pharmacists to dispense a one-time emergency refill of a prescription for a non-controlled medication for up to 14 days. This allows patients in an emergency situation, the flexibility needed to schedule an appointment with their doctor, without suffering from interrupted medication therapy. Signed by the Governor on March 29th.
SB1269-Scope Expansion: Oral Health Allows Arizona pharmacists the ability to administer oral fluoride varnishes to eligible patients according to ADA guidelines. Pharmacists will perform a caries risk assessment on every patient, provide a fluoride record card to track treatments between providers, and make necessary referrals. Signed by the Governor on March 29th.
Spring 2017 • Arizona Journal of Pharmacy • 11
LEGISLATIVE UPDATE Arizona Pharmacists can Dispense Naloxone Without a Prescription As a result of the passage of HB2355, pharmacists can now dispense Naloxone without a prescription! Complete the AzPA training today to make an impact in your community! https://azpa.learningexpressce.com All AzPA members are welcome to attend the monthly Legislative Affairs Committee meetings. If you are interested in joining the discussions, contact AzPA.
Who’s representing you?
Kelly L. Fine, R.Ph., FAzPA AzPA Chief Executive Officer
Erin Roy AzPA Legislative Liaison
Jessie Armendt Axiom Public Affairs AzPA Contract Lobbyist
Mark Boesen, JD, Pharm.D., FAzPA (right) Ken Bykowski, BS Pharm, MSHSA (left) AzPA Legislative Committee Co-Chairs
Help support our Legislative Efforts by contributing to the Pharmacists Political Action Committee of Arizona (PharmPAC). www.azpharmacy.org/PharmPAC
FEATURED HIGHLIGHTS PROVIDERSTATUS
PHARMACISTSPROVIDECARE.COM
What’s new in key Congressional committees
H
ealth care is set to dominate the 115th Congress’s legislative agenda. This is good news for the pharmacy profession— Congressional interest and action will provide the opportunity to advance issues of importance to pharmacy, including the Pharmacy and Medically Underserved Areas Enhancement Act (H.R. 592/S. 109). While there is not much agreement between the political parties on health care reform, H.R. 592/S. 109 has received overwhelming bipartisan support, with 138 cosponsors in the U.S. House of Representatives and 32 in the U.S. Senate at press time. Committees to watch
Most of the work on legislation is done by Congressional committees, where legislators study, debate, and amend bills before they proceed to the full chamber for a vote.
APhA remains focused on building grassroots support for H.R. 592/S. 109 and motivating supporters to share their stories.
“Both Republicans and Democrats have discussed the importance of strengthening Medicare to ensure its long-term sustainability,” said Alicia Kerry Mica, APhA senior lobbyist. “APhA believes that the Pharmacy and Medically Underserved Areas Enhancement Act, with its positive effect on cost, quality, and health outcomes, is a policy that needs to be included in any Medicare reform.” APhA, along with a coalition of nearly 40 organizations representing pharmacists, patients, and other stakeholders, is working with House and Senate leadership and relevant Congressional committees to make that happen. Here’s a summary of some of the people and entities important to the passage of H.R. 592/S. 109 and other pharmacy-related bills. 56
PharmacyToday • APRIL 2017
Members of Congress lobby their respective party leadership for committee assignments on the basis of their interests and the interests of their constituents. Also considered are Members’ seniority, state, and expertise when assigning committees. Four primary committees typically consider pharmacy legislation in Congress: Energy & Commerce and Ways & Means on the House side, and Finance and Health, Education, Labor, & Pensions (HELP) on the Senate side. In the House, the House Energy & Commerce Subcommittee on Health, chaired by Rep. Michael Burgess, MD (R-TX), has jurisdiction over health information technology, Medicare Part B, Medicaid, regulation of drugs, drug abuse, and CDC. The House Ways & Means Subcommittee on Health has jurisdiction over programs providing payment for health care, health delivery systems or health research, and certain health
care programs under the Social Security Act, most notably Medicare Parts A and B. This subcommittee is led by Rep. Pat Tiberi (R-OH). The Senate Finance Committee oversees legislation dealing with health care programs under the Social Security Act, including Medicare, Medicaid, and the Children’s Health Insurance Program. The Senate HELP Committee has jurisdiction over biomedical research and development, occupational safety and health, public health, and student loans. These committees are chaired by Sens. Orrin Hatch (R-UT) and Lamar Alexander (R-TN), respectively. Notable new committee members
Rep. Earl L. “Buddy” Carter (R-GA), the only pharmacist currently serving in Congress and an H.R. 592 cosponsor, was appointed to serve on the House Committee on Energy & Commerce Subcommittee on Health in the 115th Congress. Reps. Brian Higgins (D-NY) and Terri Sewell (D-AL), both cosponsors of H.R. 592 during the 114th Congress, will join the House Committee on Ways & Means Subcommittee on Health. In the Senate, Sen. Todd Young (R-IN) has joined HELP’s health subcommittee for the 115th Congress. Young is newly elected to the Senate but served in the House last session, where he was a lead cosponsor of H.R. 592. APhA priorities
APhA remains focused on building grassroots support for H.R. 592/S. 109 and motivating supporters to share their stories. Being a successful advocate is not a short-term commitment. Passage of this legislation relies on pharmacists’ engagement in the legislative process and willingness to stay in contact with the lawmakers who represent them in Congress, particularly those who serve on the committees that address health care. Stay tuned to www.pharmacistsprovidecare.com to keep up with the latest news on the legislation. Rachel Balick, assistant editor www.pharmacytoday.org
Spring 2017 • Arizona Journal of Pharmacy • 13
FEATURED HIGHLIGHTS PROVIDERSTATUS
Ohio patient relies on his anticoagulation pharmacist’s watchful care
T
he patient, “Frank,” had an international normalized ratio (INR) of 14. While that number is alarming, this is the type of situation that pharmacists at the Jobst Anticoagulation Service at ProMedica Toledo Hospital in Toledo, OH, are prepared to address. “Some physicians would send a patient with an INR of 14 to the emergency room, but if the patient doesn’t have any bruising or bleeding, we can safely and effectively treat them on an outpatient basis,” said Melissa Albright, PharmD, manager and clinical pharmacist at the clinic.
At the Jobst Anticoagulation Service, Albright and her pharmacist colleagues closely monitor patients taking warfarin to make sure the medicine is working properly. Warfarin management includes regular visits with patients to perform INR blood tests and provide warfarin dosing; counsel on lifestyle factors, such as diet and alcohol consumption, that could interfere with the anticoagulant; coordinate procedure plans; and complete medication reconciliation. In a country where strokes kill more than 130,000 people every year, pharmacist-provided anticoagulation management helps patients avoid bleeds and blood clots, including heart attacks and strokes, to keep them out of hospitals and emergency departments. When initiating warfarin therapy, pharmacists might see their patients every 3 days, eventually extending the time between visits to every 4 to 6 weeks. “It’s a gradual process [of] making sure we have the patient on the right dose. Each patient needs a specific dose, and we have to personalize that,” said Albright. Pharmacist provider status needed
Warfarin management is well matched to the skills and expertise of pharmacists. However, CMS does not recognize pharmacists as health care providers, which means that few private insurers recognize them, either.
When Frank’s pharmacist read his results, she called him right away to see if he had any bruising or bleeding. “Sometimes patients will have nosebleeds, cough Melissa Albright up blood, or see blood in the urine or stool,” said Albright. Fortunately, Frank wasn’t having any of these adverse effects. The pharmacist instructed him to hold warfarin and take vitamin K while she
PHARMACISTSPROVIDECARE.COM
to track their patients’ adherence and therefore send in the prescriptions themselves. Unfortunately, this can result in a harmful but preventable outcome. Frank is just one patient who relies on the watchful care of his anticoagulation pharmacist. It’s not uncommon for pharmacists at Jobst to meet patients who are taking medications that interact with their anticoagulants’ effects or patients who are taking more than one anticoagulant. Teaming up on transitions of care
Transitions from hospital to home are often a source of dangerous medication errors. Recently, a patient asked a Jobst pharmacist why she had to take both apixaban and warfarin and two different aspirin doses. The answer was that she didn’t have to take both anticoagulants and that she shouldn’t. The patient was taking one of the anticoagulants before she was admitted to the hospital, unbeknown to the inpatient provider, and then put on another in the hospital. This same process happened with the aspirin. Upon discharge, without any
“Physicians are the diagnosis experts, while pharmacists are the medication experts.” investigated the reason for the high INR in the first place. When a patient’s INR is too high or too low, pharmacists must ask a series of questions. They ask about medication and dietary changes, missed doses, and recent hospitalizations—among a host of other issues that could affect the medication’s efficacy. “It turned out the patient’s primary care provider had called in the wrong warfarin tablet strength to the pharmacy,” said Albright. Although pharmacists are able to send in warfarin prescriptions, some physicians prefer
advice to the contrary, she continued taking both anticoagulants and aspirin doses. Her pharmacist rectified the problem. “Pharmacists are well positioned to do medication reconciliation during transitions of care,” said Albright. Physicians are the diagnosis experts, Albright added, while pharmacists are the medication experts. “If everyone works together as a team, that’s what is ultimately going to give patients the best care.” Sonya Collins, contributing writer
Provider status stories Pharmacists are health care providers. In a series of profiles appearing in Pharmacy Today and on pharmacist.com, pharmacists explain how their patients would benefit from provider status. And as part of our campaign for provider status, APhA has asked pharmacists to share their story of how they provide care to their patients and how provider status will improve health care. These stories are collected on the APhA YouTube channel at https://www.youtube.com/user/aphapharmacists/playlists. If you would like to share your story, please visit PharmacistsProvideCare.com. www.pharmacist.com
Provider Status Credits
APRIL 2017 •
PharmacyToday 57
Reprinted with permission from the Provider Status column in the April 2017 issue of Pharmacy Today (www.pharmacytoday. org), page 56-57. For more information about ways for pharmacists and student pharmacists to follow and influence the profession’s efforts to achieve provider status, access the provider status recognition section of APhA’s website (www.pharmacist.com/ providerstatusrecognition) and APhA’s Pharmacists Provide Care website (PharmacistsProvideCare.com). Copyright © 2017, American Pharmacists Association. All rights reserved.
2017 annual convention westin la paloma resort and spa
Hotel Information: 3800 East Sunrise Dr. Tucson, Az 85718 520.742.6000 or 1.800.228.3000
When making your hotel reservation, please identify yourself as an attendee at the AzPA Annual Convention. Rooms are available on a first-come, first-served basis. In order to receive the special room rate, reservations must be made by:
May 20, 2017
Room Information: Standard room: $129.00/ night* Suite: $350/ night *Single/ Double rate (Resort Services Fee, and State & local taxes not included in prices above)
schedule at a glance
Thursday June 8, 2017 8:00am - 5:00pm 8:00am - 5:00pm 8:00am - 5:00pm 5:30pm - 7:00pm 7:00pm - 8:00pm
Immunization Certificate Program (Pre-registration required) Psychiatric Certificate Program (Pre-registration required) APhA Delivering MTM Services Certificate Program (Pre-registration required) AzPA Board of Directors Meeting Welcome Reception (Open to all Conference Registrants) Lunch and dinner will be provided
Friday June 9, 2017 6:30am - 5:00pm 8:00am - 5:30pm 8:30am - 9:30am 9:45am - 10:45am 11:00am - 12:00pm 1:15pm - 2:15pm 2:30pm - 3:30pm 3:45pm - 5:15pm 5:30pm - 7:00pm 7:00pm - 8:00pm
Registration 3rd Annual Southwestern States Residency Conference (Separate registration required) General Session 1 General Session 2 Breakout Sessions: Choose from 2 different CE Sessions General Session 3 Breakout Sessions: Choose from 2 different CE Sessions AzPA Focus Groups (Includes CE Credit) Exhibit Hall Dinner Friends of Midwestern University Reception Breakfast & Lunch will be provided
Saturday June 10, 2017 6:30am - 5:00pm 7:00am - 8:00am 8:30am - 10:00am 9:00am - 2:00pm 10:15am - 11:15am 11:30am - 12:30pm 12:30pm - 2:00pm 2:15pm - 3:45pm 4:00pm - 5:00pm 5:30pm - 6:30pm 7:00pm - 8:00pm 8:00pm - 10:00pm
Registration Not e Speed Networking (Bonus CE) incl : Satu u General Session 1 tec des st rday hnic u ian dent a Poster Contest trac n ks! d Breakout Sessions: Choose from 5 different CE Sessions (Includes Business Track) Breakout Sessions: Choose from 2 different CE Sessions (Includes Business Track) Exhibit Hall Lunch General Session 2 Breakout Sessions: Choose from 2 different CE Sessions Friends of University of Arizona Reception PharmPAC Reception (Separate Fee required: $25.00) Celebration Event (Live Band/ Casino Games/ Networking) Breakfast & Lunch will be provided
Sunday June 11, 2017 6:30am - 2:00pm 6:30am - 7:30am 8:00am - 9:30am 9:45am - 10:45am 11:00am - 12:00pm 12:00pm - 1:30pm 1:45pm - 3:15pm 3:30pm - 4:30pm
Registration Networking-Coffee Talk (Bonus CE) General Session 1 Breakout Sessions: Choose from 3 different CE Sessions (Includes Business Track) Breakout Sessions: Choose from 3 different CE Sessions (Includes Business Track) Awards Lunch Breakout Sessions: Choose from 2 different CE Sessions Breakout Sessions: Choose from 2 different CE Sessions (Includes Business Track) Breakfast & Lunch will be provided
Spring 2017 • Arizona Journal of Pharmacy • 15
Final ACPE information will be available in the final program. friday june
9, 2017
8:30AM-9:30AM GENERAL SESSION 1 ARIZONA STRATEGIES FOR COMBATING PRESCRIPTION DRUG ABUSE/ OPIOD EPIDEMIC* Shana Malone, M.S. AHCCCS 9:45AM-10:45AM GENERAL SESSION 2 REDUCING HOSPITAL READMISSIONS IN HEART FAILURE: PHARMACY’S PIVOTAL ROLE Michael B. Bottorff, PharmD, FCCP, FNLA, CLS • Describe the high incidence and burden of HF, including the risk of hospitalization and the need to meet quality metrics for the reduction of readmissions in HF. • Explain the complex pathophysiology and risk factors for HF. • Integrate new classes of pharmacologic agents for HF into the current effective treatment paradigm. • Plan for the use of biomarkers and novel electronic monitoring technologies to workup. • Monitor treatment follow-up and medication adjustment in HF. 11:00AM-12:00PM BREAKOUT SESSIONS FAT AS PHARMACOTHERAPY: A PHARMACIST’S GUIDE TO FAT ADAPTION AND DIETARY KETOSIS Cory Jenks, PharmD, BCPS, BCACP • Describe how insulin leptin and ghrelin influence appetite, metabolism and fat storage. • Identify the physiologic benefits of fat adapted and ketogenic diets. • Describe the mechanisms of fat adapted and ketogenic diets therapeutic effects in a variety of diseases. DEATH WITH DIGNITY IN THE UNITED STATES: HISTORY AND CURRENT DISCUSSION Alan Barreuther, PharmD. • Review the history of the patient-initiated movement for the “right to die” within the United States. • Review the current polling of voter attitude toward the topic of medical aid in dying for terminally ill adults. • Provide in your own words, the definition of euthanasia, physician-assisted suicide, suicide, and aid in dying. • Describe the “pro” and “con” debate surrounding “death with dignity” discussion. 1:15PM-2:15PM GENERAL SESSION 3 HISTORY OF PHARMACISTS ASSISTING PHARMACISTS (PAPA) OF ARIZONA Hal Wand, RPh; Mark Murphy, RPh • Review the history of the Pharmacists Assisting Pharmacists (PAPA) monitoring program. • Identify the mission of the Arizona Pharmacy Foundation and PAPA monitoring program. 2:30PM-3:30PM BREAKOUT SESSIONS PRECEPTOR WORKSHOP: CHRISTMAS IN JULY – A SUCCESSFUL FAILURE STORY
• Define what “successful failure” is. • Summarize productive ways to turn failures into successful failures. • Apply the productive use of successful failures in pharmacy practice to facilitate growth in both learners and preceptors. HEALTH CURRENT: WHAT’S AHEAD FOR ARIZONA’S HEALTH INFORMATION EXCHANGE (HIE) Melissa Kotrys, MPH, CEO, Health Current • Describe the factors and forces that were behind the unprecedented growth that made Arizona’s HIE one of the fastest growing in the nation • Define what “successful failure” is • Summarize productive ways to turn failures into successful failures • A pply the productive use of successful failures in pharmacy practice to facilitate growth in both • learners and preceptors 3:45PM-5:15PM BREAKOUT SESSIONS AzPA FOCUS GROUPS - 1.5 hours CE • Describe the new strategic vision of AzPA to transform our profession into the future • Identify opportunities for the association to better meet your needs as a pharmacy professional • Examine different re-branding ideas that will contribute to the overall strategic plan 5:30PM - 7:00PM exhibit hall dinner 7:00PM - 8:00PM reception Friends of Midwestern University
saturday june
10, 2017
7:00AM-8:00AM bonus ce SPEED NETWORKING Elizabeth Louton, PharmD • Gain networking skills while meeting fellow convention attendees. • Practice giving your personal “elevator speech” to aid in future professional networking opportunities. 8:30AM-10:00AM GENERAL SESSION 1 THE BRAIN AND RECOVERY: AN UPDATE ON NEUROSCIENCE OF ADDICTION Kevin McCauley, MD • Summarize both the relevant neuroanatomy and the latest neuroscientific explanations of substance use disorder pathophysiology as well as correctly interpret SUD symptomology in light of this research. • Describe the evidence supporting substance use disorder as a brain disease but also understand the limitations of the “disease model” in trying to frame addiction as a volitional disorder. Attendees will grasp the importance of the current transition from an acute care/medical model to a chronic care/public health model. • Describe the diverse models of professional treatment and community-based support can suggest strategies to restore volitional capacity and functionality in people in recovery from substance use disorders.
Janet Cooley, PharmD; Suzanne Larson, PharmD; Melinda Burnworth, PharmD, BCPS, FASHP, FAzPA
• Describe who fails, where it occurs, and why it happens.
10:15AM-11:15AM BREAKOUT SESSIONS
NEUROLOGY UPDATE: DRUG THERAPIES FOR MULTIPLE SCLEROSIS* Lindsay Kittler, PharmD, BCPS • Describe the principal differences between primary progressive, secondary progressive and relapsingremitting multiple sclerosis. • Identify disease modifying therapies associated with a more rapid onset of symptom control for patients following acute presentation of multiple sclerosis. • Recognize principal adverse effects associated with select disease modifying therapies for multiple sclerosis. NALOXONE TRAINING Mark Boesen, PharmD, JD; Amy Kennedy, PharmD, BCACP • Describe the principal differences between primary progressive, secondary progressive and relapsingremitting multiple sclerosis. • Identify disease modifying therapies associated with a more rapid onset of symptom control for patients following acute presentation of multiple sclerosis. • Recognize principal adverse effects associated with select disease modifying therapies for multiple sclerosis. DIRECT ORAL ANTICOAGULANTS IN ONCOLOGY PATIENTS Ali McBride, PharmD, MS, BCPS, BCOP • Review the current DOAC’s available for use in the treatment of VTE. • Summarize clinical study outcomes in cancer patients. • Identify drug interactions with oncology medications and DOAC’s. 11:30AM-12:30PM BREAKOUT SESSIONS SO YOU WANT TO BE A MENTOR? Lindsay Davis, PharmD, BCPS, Ash-CHC, FAzPA • Describe the structure of the AzPA Mentor Connection Program. • Identify ways to promote personal and professional development. • Empower future colleagues with tolls and resources to be successful. • Discuss how to create long-term relationships that are mutually beneficial.
patient in need of emergent reversal. • Identify reversal agents currently in development or seeking FDA approval. 12:30PM - 2:00PM exhibit hall lunch 2:15PM-3:45PM GENERAL SESSION 2 RESOURCES & UPDATES ON COLLABORATIVE PRACTICE AGREEMENTS Krystalyn Weaver, PharmD • Define collaborative practice agreements (CPAs) and identify their role in providing team-based care. • Describe approaches for developing a trusting relationship with other healthcare professionals that may lead to the development of a CPA • Identify components that should be included in a CPA and resources available for pharmacists looking to establish a CPA • Identify key features of CPA authority in Arizona. 4:00PM-5:00PM BREAKOUT SESSIONS IMMUNIZATION UPDATE: INS & OUTS OF PENUMOCOCCAL VACCINATIONS Laura Hanson, PharmD, BCGP; Nicole Early, PharmD, BCPS, BCGP • Describe the burden of pneumonia in target demographics and the impact of vaccination of prevention of pneumonia. • Compare and contrast commercially available pneumococcal vaccine preparations. • Develop an appropriate pneumococcal vaccine care plan for a given individual. • Synthesize a plan for pharmacist involvement in pneumococcal vaccine promotion in variety of care settings. ADHERENCE AND YOUR ROLE TO IMPROVING HEALTH OUTCOMES Patrick Hryshko, PharmD. • Describe the importance of adherence. • List the consequences of non-compliance in health outcomes. • Recognize ways to mitigate non-compliance.
WHAT’S NEW WITH THE DIAGNOSIS AND TREATMENT OF AUTISM SPECTRUM DISORDER Martha Fankhauser, MS, PharmD, BCPP, FASHP, FAzPA • Review the clinical presentation of Autism Spectrum Disorder (ASD). • Assess the common co-occurring genetic, psychiatric, and medical disorders associated with ASD. • Describe preventative approaches to reduce the risk of ASD. • Evaluate the value and role of pharmacologic and nonpharmacologic approaches in the symptomatic treatment of ASD.
4:00PM - 5:30PM FROM A TO Z: CLINICAL PEARLS FOR PHARMACISTS Melinda Burnworth, PharmD, BCPS, FASHP, FAzPA; Panel of speakers • Evaluate clinical scenarios or “clinical pearls” that might not be widely known or published. • Apply novel clinical practice options for patient care in various health settings. • Value medication management strategies in difficult or controversial patient care situations. • Assemble clinical information that can be applied to applicable working settings.
REVERSAL OF ORAL ANTICOAGULANTS: WHERE ARE WE, AND WHERE ARE WE GOING Jacob Schwarz, PharmD, BCCP, BCPS • Distinguish between the uses of currently approved reversal agents specific to certain oral anticoagulants and their mechanism of action. • Review the efficacy of each of these agents as demonstrated in the literature. • Design a treatment plan on the presentation of a specific
5:30PM - 6:30PM reception Friends of University of Arizona 7:00PM - 8:00PM reception PharmPAC 8:00PM - 10:00PM casino night Celebration with live band, casino games and networking!
sunday june 11, 2017 6:30AM - 7:30AM bonus ce Coffee Talk: Journal Club on Caffeine Elizabeth Louton, PharmD. • Gain knowledge about newly released drug studies and articles. • Review the relevance and practice implications of the reviewed drug studies and articles with your peers. 8:00AM-9:30AM GENERAL SESSION PHARMACY LAW UPDATE 2017 Roger Morris, RPh, JD • Identify major developments in U.S. pharmacy law and related fields. • Describe the practical ramifications of proposed state and national legislative initiatives. • Recognize emerging patterns that will broadly affect the healthcare field. 9:45AM-10:45AM BREAKOUT SESSIONS ANTIBIOTIC RESISTANCE AND THE NOVEL BETALACTAMASE INHIBITORS: A NEW HOPE? Christina Suguitan, PharmD, • Recognize the significance of antibiotic resistance to the health care system and society. • Describe the mechanism of beta-lactamase enzymes and how they confer resistance. • Compare and contrast avibactam and the older beta – lactamase inhibitors. • List current indications for the new beta-lactam/betalactamase inhibitor combinations (BLICs), ceftolozanetazobactam and ceftazidime-avibactam. • Describe some of the available in vitro and clinical data for the use of the new BLICs. • Compare and contrast potential future BLICs. OPTIMIZING CHRONIC SYSTOLIC HEART FAILURE: NEW APPROACHES BRING NEW INSIGHTS Elizabeth Pogge, PharmD, BCPS, MPH, FASCP; Lindsay Davis, PharmD, BCPS, ASH-CHC, FAzPA • State the current standard of care for the treatment of chronic systolic heart failure, including lifestyle changes and pharmacotherapy. • Apply pharmacodynamic principals of loop diuretic dosing to chronic heart failure management. • Analyze a patient for appropriate use of ivabradine or sacubitril/valsartan therapy. • Discuss the pharmacist’s role in managing chronic heart failure, both in the clinic setting as well as in the community pharmacy. (Pharmacists only) BUSINESS TRACK: REIMBURSABLE PHARMACY SERVICES FOR AMBULATORY PATIENTS Nicole Scovis, PharmD, BCPS, BCACP • Discuss the requirements of annual wellness visits, incident-to, chronic care management and complex chronic care management services. • Identify appropriate resources for further information on requirements of pharmacist billing opportunities under the Centers for Medicare and Medicaid Services. • Summarize ways in which annual wellness visits, incident-to, chronic care management and complex Chronic care management are being used by pharmacists
in Arizona. 11:00AM-12:00PM BREAKOUT SESSIONS WHAT (REALLY) TO EXPECT WHEN YOU’RE (A PHARMACIST) EXPECTING! A REFLECTION ON THE BEAUTIFUL COMPLEXITY OF PARENTHOOD AND PROFESSIONAL LEADERSHIP Melinda Burnworth, PharmD, BCPS, FASHP, FAzPA; Samantha Karr, PharmD, BCPS; Shareen El-Ibiary, PharmD, FCCP, BCPS • Describe the current pharmacy workforce demographics and gap in leadership gender diversity. • Share anecdotes and personal testimonies of balancing parenthood and pharmacy leadership. • Empower pharmacists to be leaders in their personal and professional lives. INFECTIOUS DISEASE William Frank, Maricopa County Department of Public Health Services BUSINESS TRACK: WHAT YOU NEED TO KNOW AS PHARMACIST-IN-CHARGE (PIC) Kamlesh Gandhi, PharmD • Discuss the legal obligations of the PIC. • Describe the PIC requirements in Arizona. • Compare differences between PIC requirements in a non-community practice setting. 12:00PM - 1:30PM luncheon Annual Awards 1:45PM-3:15PM BREAKOUT SESSIONS NEW DRUG UPDATE Robert J. Lipsey, PharmD, BCPS, FASHP • Compare the advantages and disadvantages of the currently available GLP-1 receptor inhibitors. • Retrieve and evaluate critical information on newly approved drugs to determine their place in therapy. • Identify a life-threatening drug-drug interaction between sofosbuvir/velpatasvir and a common cardiac medication. ANTIMICROBIAL STEWARDSHIP FOCUSED ON COMMUNITY SETTINGS IN AZ: READY FOR PRIME-TIME* Mark A. Redell, BS, PharmD; Rachana Bhattarai, BVSc&AH, MS, CIC; Keith Chartier, MPH • Recognize global initiatives to improve the use of antibiotics, including programs in the United States. • Review the major elements of the Government’s plan to combat antibiotic resistance. • Discuss antimicrobial stewardship metrics in both acute care hospitals and long-term care settings. • Describe hospital leadership and national action plans by the CDC, TJC, and other groups which mandate antimicrobial stewardship programs in the U.S. as a performance measure. • Identify resources in the state of Arizona to assist in preparing a hospital structure to support stewardship. • Initiate achieve hospital leadership support, medical staff skill sets, and documentation for CMS audit.
3:30PM-4:30PM BREAKOUT SESSIONS ONCOLOGIC EMERGENCIES FOR THE EVERYDAY PHARMACY PROFESSIONAL Alyssa Hinchman, PharmD, • Identify patients presenting with selected oncologic emergencies. • Summarize current recommendations for the management of selected oncologic emergencies in the acute care setting. • Discuss the management strategies for oncologic emergencies in the emergency department compared to unit-based care and the rationale for these differences. • Select the best therapeutic approach for an oncologic emergency in a given case scenario. BUSINESS TRACK: ENHANCED COMMUNITY PHARMACY NETWORKS* Ashley Branham, PharmD, BCACP • Discuss common characteristics of pharmacies in a community pharmacy enhanced service network • Describe how pharmacies are positioning themselves to integrate with care teams to lower health care costs and participate in new models of care and reimbursement
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Second Quarter 2017: Pharmacy Time Capsule 1992 • Oncologic pharmacy recognized as a specialty by BPS. • Pharmacy sales in the US totaled approximately $77.8 billion dollars. This expanded to almost $154 billion in 2002. 1967 • Drug Intelligence, later retitled to Drug Intelligence and Clinical Pharmacy and more recently Annals of Pharmacotherapy, inaugurated by editor and founder Donald Francke. 1942 • American Society of Hospital Pharmacists (ASHP), now the American Society of Health-System Pharmacists, formed with 153 charter members. 1892 • Formation of the Utah Pharmacists Association By: Dennis B. Worthen, PhD, Cincinnati, OH
One of a series contributed by the American Institute of the History of Pharmacy, a unique non-profit society dedicated to assuring that the contributions of your profession endure as a part of America’s history. Membership offers the satisfaction of helping continue this work on behalf of pharmacy, and brings five or more historical publications to your door each year. To learn more, check out: www.aihp.org
PHARMACY COMICS
“Indiana Pharmacist and the Raiders of the Lost Prescription”
Artist: James Montague, R.Ph., Managed Care Academy Chair-Elect Spring 2017 • Arizona Journal of Pharmacy • 21
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CONTINUING EDUCATION Use of Colony-Stimulating Factors in Established Febrile Neutropenia ACPE UAN: 0100-0000-17-045-H01-P
Eric B. Vertin, PharmD, PGY-1 Resident; Banner Boswell Medical Center Steven MacKay, PharmD, BCPS, BCGP, Clinical Pharmacist: Banner Boswell Medical Center
Abstract Purpose To analyze evidence supporting the use of granulocytic colony-stimulating factors (CSFs) in the treatment of established febrile neutropenia.
established febrile neutropenia in patients with high risk criteria may be supported. However, additional evidence is needed to support the broad use of granulocytic CSFs in patients with established febrile neutropenia.
Summary Granulocytic colony-stimulating factors (CSFs) are primarily used for the prophylaxis of neutropenia after myelosuppressive chemotherapy or radiation therapy. Evidence for the use of granulocytic CSFs in established febrile neutropenia is not well established. A 2001 randomized control trial published in the Journal of the National Cancer Institute analyzed the use of G-CSF in combination with antibiotics as compared with antibiotics alone in 210 patients with febrile neutropenia. The results of this study showed significantly decreased duration of hospitalization, decreased duration of grade 4 neutropenia, decreased duration of antibiotic therapy, and decreased cost of hospitalization in patients treated with G-CSF in combination with antibiotic therapy.
Background Colony-stimulating factors (CSFs) are glycoproteins that function to regulate the proliferation and differentiation of hematopoietic stem cells.1 Two recombinant granulocytic CSFs that are commonly used clinically include granulocyte colonystimulating factor (G-CSF) and granulocytemacrophage colony-stimulating factor (GMCSF).1 Recombinant G-CSF is available as filgrastim, tbo-filgrastim, filgrastim-sndz, and the long-acting formulation pegfilgrastim. Recombinant GM-CSF is available as sargramostim. G-CSF functions to stimulate the proliferation of neutrophil precursors and mature neutrophils, whereas GM-CSF stimulates the proliferation of all granulocyte progenitors, mature granulocytes, monocyte progenitors, and mature monocytes. GM-CSF has addition stimulating effects on erythroid progenitors and megakaryocyte progenitors.1,2
A 2014 systematic review published in the Cochrane Database of Systematic Reviews analyzed 14 randomized control trials that used G-CSF or GM-CSF in combination with antibiotics as compared with antibiotics alone. The results of this systematic review showed that patients who received granulocytic CSFs were less likely to be hospitalized for more than 10 days, had a shorter duration of neutropenia, had faster recovery from fever, and had a shorter duration of antibiotic use as compared with those receiving antibiotics alone. Given the results of these studies, the use of granulocytic CSFs in the treatment of
Recombinant granulocytic CSFs are primarily used in the prophylaxis of neutropenia in patients receiving myelosuppressive chemotherapy or radiation therapy.1,2 The use of granulocytic CSFs in the prophylaxis of neutropenia in this setting is well supported. The prophylactic use of granulocytic CSFs is recommended in patients with a history of neutropenia-related complications or patients with greater than 20% risk of developing neutropenia following chemotherapy based on factors specific to the patient, disease, and type of treatment.3 Factors for developing febrile neutropenia include age of 65 or older, Spring 2017 • Arizona Journal of Pharmacy • 23
advanced disease, previous chemotherapy or radiation therapy, preexisting neutropenia, tumor with bone marrow involvement, and infection among others.3 The bulk of clinical trials investigating the efficacy of granulocytic CSFs focus solely on their prophylactic use. While the use of granulocytic CSFs in the prevention of febrile neutropenia is well supported, evidence supporting their use in the management of established febrile neutropenia is insufficient. Evidence A 2001 randomized control trial published in the Journal of the National Cancer Institute analyzed the use of G-CSF in established febrile neutropenia.4 This trial included 210 patients with solid tumors who were treated with conventional-dose chemotherapy who also presented with grade 4 neutropenia (Table 1) along with fever (defined as one axillary temperature of above 38 °C). To be included in the trial, patients also needed to meet one of the high risk criteria defined by the authors. These criteria included profound neutropenia (absolute neutrophil count (ANC) less than 100 per cubic millimeter), close time proximity to the previous cycle of chemotherapy (fewer than 10 days), and sepsis or infection at presentation among others. Patients were randomized to receive a standardized antibiotic regimen including ceftazidime and amikacin with or without G-CSF, dosed as 5 micrograms per kilogram per day. The primary endpoint of this study was the duration of hospitalization; secondary endpoints included duration of grade 4 neutropenia, duration of grade 3 neutropenia, duration of antibiotic therapy, incidence of serious medical complications, mortality, and cost of hospitalization among others.4 In this trial, the authors found that patients receiving adjunctive G-CSF with antibiotic therapy had a significantly decreased duration of hospital stay (median 5 days versus 7 days, p-value 0.015), decreased duration of grade 4 neutropenia (median 2 days versus 3 days, p-value 0.0004), decreased duration of grade 3 neutropenia (median 3 days versus 4 days, p-value <0.0001), decreased duration of antibiotic therapy (median 5 days versus 6 days, p-value 0.013), and decreased cost of hospitalization (reduced by 17%, p-value 0.01) as compared with those treated with antibiotics alone. The authors found no Spring 2017 • Arizona Journal of Pharmacy • 24
significant difference in incidence of serious medical complications or mortality between the two groups.4 The results of this trial may support the therapeutic use of G-CSF in established febrile neutropenia in patients with solid tumors, showing reduced duration of hospital stay, reduced duration of neutropenia, reduced duration of antibiotic therapy, and reduced cost of hospitalization. Notably, this study failed to show any benefit in mortality outcomes. One of the limitations of this study lies in its inclusion criteria. This trial only included patients who met the established list of high-risk criteria. Because of this, the study may have limited external validity; the results of this trial can only truly be applied to patients who meet the same high-risk criteria established by the authors. A 2014 systematic review published in the Cochrane Database of Systematic Reviews also analyzed the use of granulocytic CSFs in chemotherapy-induced febrile neutropenia.5 This systematic review analyzed 14 trials, including a total number of 1553 patients. All of the selected studies were randomized control trials that compared granulocytic CSFs (either G-CSF or GM-CSF) plus antibiotics versus antibiotics alone in the treatment of established chemotherapy-induced febrile neutropenia. Of the 14 trials analyzed in this systematic review, 3 trials included only patients with hematological malignancies, 1 trial included only patients with solid tumors, and 10 trials included both patients with solid tumors and patients with hematological malignancies. 10 trials included only adults, 3 trials included only children, and 1 trial included both adults and children. 6 trials included patients with grade 3 or grade 4 neutropenia, and 8 trials included only patients with grade 4 neutropenia. 7 trials used G-CSF as a part of treatment, 6 trials used GM-CSF as a part of treatment, and 1 trial used either G-CSF or GM-CSF as a part of treatment. Major outcome measures assessed in this systematic review included overall mortality, infectionrelated mortality, risk of hospitalization for more than 10 days, time to neutrophil recovery (assessed by number of patients with ANC of less than 1000 per cubic millimeter for more than 5 days), duration of grade 4 neutropenia, time to recovery from fever (defined as greater than 38 °C) and others.5
The authors of this systematic review found that patients with established febrile neutropenia who were treated with granulocytic CSFs and antibiotics were less likely to be hospitalized for more than 10 days (risk ratio 0.65, 95% confidence interval (CI) 0.44 to 0.95), had a shorter duration of grade 4 neutropenia (standard mean difference -1.70, 95% CI -2.65 to -0.76), had faster recovery from fever (standard mean difference -0.40, 95% CI -0.90 to -0.09), and had a shorter duration of antibiotic use (standard mean difference -1.50, 95% CI -2.83 to -0.18) as compared with those receiving antibiotics alone. There was no significant improvement in overall mortality (hazard ratio 0.74, 95% CI 0.47 to 1.16) or infection-related mortality (hazard ratio 0.75, 95% CI 0.47 to 1.20).5 The results of this systematic review may support the use of granulocytic CSFs in established febrile neutropenia. A major limitation in this study is the quality of the data. As a systematic review, the quality of this study’s results is somewhat limited. Results of a higher statistical quality may have been produced if the data were analyzed through a pooled analysis instead of systematic review. Regardless, the results of this systematic review may support the use of granulocytic CSFs in established febrile neutropenia.5 Conclusion The use of granulocytic CSFs in the management of established febrile neutropenia is still unclear. Based on the results of the referenced 2001 randomized control trial4, the use of G-CSF in patients with solid tumors who present with established febrile neutropenia along with high-risk criteria resulted in a significantly reduced duration of hospital stay, reduced duration of neutropenia, reduced duration of antibiotic therapy, and reduced cost of hospitalization. The referenced 2014 systematic review5 found that the use of granulocytic CSFs in patients with established febrile neutropenia resulted in reduced risk of hospitalization prolonged beyond 10 days, reduced duration of neutropenia, reduced time to recovery from fever, and reduced duration of antibiotic use. As a systematic review, the quality of the data from this study is somewhat limited. Given the results
presented by the referenced literature, the use of granulocytic CSFs in the treatment of established febrile neutropenia in patients with high risk criteria may be supported. However, additional evidence is needed to support the use of granulocytic CSFs broadly in all patients with established febrile neutropenia.
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Spring 2017 • Arizona Journal of Pharmacy • 25
Table 1. CTCAEa Grade Severity of Neutropenia Neutropenia Grade Severity Absolute Neutrophil Count Grade 1 Less than 1500 per cubic millimeter Grade 2 1000 to 1499 per cubic millimeter Grade 3 500 to 999 per cubic millimeter Grade 4 Less than 500 per cubic millimeter Grade 5 Death CTCAE = Common Terminology Criteria for Adverse Events
a
References
1. Metcalf, D. The colony-stimulating factors and cancer. Nature Reviews Cancer. 2010; 10:425-34. 2. Gomez RC. Pinto MA. Gonzalez BM. Colony-stimulating factors: clinical evidence for treatment and prophylaxis of chemotherapy-induced febrile neutropenia. Clin Transl Oncol. 2006; 8(10):729-34. 3. Smith, TJ. Bohlke, K. Lyman, GH et al. Recommendations for the use of WBC growth factors: American Society of Clinical Oncology Clinical Practice Guideline Update. J Clin Oncol. 2015; 33(28):3199-212. 4. Garcia-Carbonero R. Mayordomo JI. Tornamira MV et al. Granulocyte colony-stimulating factor in the treatment of high-risk febrile neutropenia: a multicenter randomized trial. J Natl Cancer Inst. 2001; 93(1):31-8. 5. Mhaskar R. Clark OA. Lyman G et al. Colony-stimulating factors for chemotherapy-induced febrile neutropenia. Cochrane Database Syst Rev. 2014; 10:CD003039.
The Arizona Pharmacy Association is an accredited provider of continuing pharmacy education. This knowledge based activity has been approved for 0.5 contact hours of CE for pharmacists. Please visit AzPA’s On-Demand CE Center to obtain CE credit prior to 5/5/2020. https://azpa.learningexpressce.com
Spring 2017 • Arizona Journal of Pharmacy • 26
CONTINUING EDUCATION One Small Step for Man, a Giant Leap in Heart Failure Management: A Therapeutic Update on Heart Failure ACPE UAN: 0100-0000-17-046-H01-P/T
Authors: Kristye J. Russell, PharmD, PGY-1 Pharmacy Practice Resident; -Banner Boswell Medical Center Steven S. MacKay PharmD BCPS BCGP, Clinical Pharmacist Specialist – Banner Boswell Medical Center
Introduction: In May of 2016 a pharmacologically focused update to the 2013 ACCF/ AHA Guideline for the Management of Heart Failure was published. This update included two new medications indicated for the management of NYHA Class IIIV heart failure with reduced ejection fraction 1. These therapies include sacubitril/valsartan, a combination angiotensin receptor-neprilysin inhibitor (ARNI), and the sinoatrial modulator, ivabradine. Members from the American College of Cardiology, the American Heart Association, and the Heart Failure Society of America in conjunction with the European Society of Cardiology congruously agreed on the incorporation of these therapies into the current practice guideline 1. This therapeutic update discusses the newly recommended heart failure agents in terms of their mechanism of action and place in the management of heart failure with reduced ejection fraction (HFrEF). In addition, this update provides a brief review of the pivotal trials that merited their incorporation into the practice guideline. Angiotensin II Receptor-Neprilysin Inhibitor (ARNI): Sacubitril/valsartan is a combination product consisting of the neprilysin
inhibitor, sacubitril, and the angiotensin receptor blocker, valsartan 2, 3. Sacubitril is a prodrug that is cleaved into the active metabolite LBQ657 3. The inhibition of neprilysin, a neutral endopeptidase, results in an increase in vasoactive peptides; namely bradykinin, adrenomedullin, and natriuretic peptides, which counteract the neurohormonal pathways leading to cardiac remodeling 2. Additionally, valsartan as an angiotensin II receptor blocker opposes activation of the renin-angiotensin-aldosterone pathway, a known system involved in cardiac remodeling 2. Sacubitril/valsartan is currently indicated in the risk reduction of cardiovascular mortality and hospitalization in chronic symptomatic heart failure patients with reduced ejection fraction (HFrEF) NYHA Class II – IV 3. Sacubitril/valsartan is recommended as an alternative to ACE inhibitor or ARB therapies in addition to other guideline recommended heart failure medication therapies 1, 3. ACC/AHA/HFSA Recommendation for Angiotensin II Receptor-Neprilysin Inhibitor (ARNI): Investigational trials have long established the clinical benefit and safety of ACE inhibitors or ARBs in heart failure patients of varying levels of acuity1. Spring 2017 • Arizona Journal of Pharmacy • 27
Although sacubitril/valsartan (ARNI) demonstrated a reduction in mortality and morbidity in heart failure patients in the PARADIGM-HF trial, the available evidence currently supports the use of an ARNI as a substitute for an ACE inhibitor or ARB therapy 1. Sacubitril/ valsartan is recommended in the reduction of morbidity and mortality in HFrEF NYHA class II – III patients 1. An ARNI should replace ACE inhibitor or ARB therapy in those patients meeting the aforementioned heart failure criteria who are able to tolerate treatment with an ACE inhibitor or ARB and are currently stable on other guideline recommended heart failure medications 1. Concomitant ACE and neprilysin inhibition has been shown to increase the incidence of angioedema 1, 2. This adverse effect was demonstrated in a large investigational trial comparing the clinical outcomes of heart failure patients treated with enalapril versus omapatrilat, an ACE, neprilysin, and aminopeptidase P inhibitor 1, 2, 4. Therefore, the guideline update recommends against the simultaneous administration of an ACE inhibitor with an ARNI and advises against the use of an ARNI in patients with a history of angioedema. Additionally, when switching from an ACE inhibitor to an ARNI, a 36 hour wash out period is recommended in order to minimize the risk of angioedema 1, 2, 3. Selective Sinoatrial Inhibitor: Ivabradine is a selective inhibitor of the hyperpolarization activated cyclic nucleotide-gated f-channels regulating the pacemaker activity of the sinoatrial (SA) node 5, 6, 7. Ivabradine reduces heart rate by disrupting ionic current flow, slowing diastolic depolarization 6. Ivabradine is indicated for the reduction of hospitalization risk in stable, symptomatic chronic heart failure patients with a left ventricular ejection fraction ≤ 35 percent, in normal sinus rhythm with a resting heart rate of 70 beats per minute 1, 5. Ivabradine therapy should be considered Spring 2017 • Arizona Journal of Pharmacy • 28
in patients who are receiving a beta blocker at the highest tolerated dose or in those patients for which beta blocker therapy is contraindicated 6. ACC/AHA/HFSA Recommendation for Ivabradine: Given the demonstrated benefit of heart rate reduction on heart failure related hospitalizations in the SHIFT trial, the guideline update recommends the use of ivabradine in symptomatic NYHA class II-III stable chronic HFrEF (LVEF ≤ 35%) 1, 5 . Eligible patient meeting criteria must be in normal sinus rhythm with a resting heart rate ≥ 70 beats per minute and should also be receiving core therapy management with other guideline recommended agents, including a beta blocker at the maximum tolerated dose 1, 5. Practical Considerations: The writing committee for the guideline update acknowledges that further evaluation of sacubitril/valsartan and ivabradine is required in order to truly ascertain their place in heart failure management. Especially considering that, for ivabradine at least, application may be limited to a niche population of heart failure patients (those with an EF 35% or less in normal sinus rhythm with a resting heart rate ≥ 70 beats per minute). The PARADIGM-HF trial persuasively demonstrated the clinical benefit of concomitant neprilysin and angiotensin blockade with sacubitril/valsartan in heart failure patients. Not only were the risk for cardiac related deaths and heart failure hospitalization reduced, but reductions in all-cause mortality were also evident. Given the compelling evidence of the PARADIGM-HF trial, sacubitril/valsartan has the potential to replace ACE inhibitors as the gold standard of heart failure therapy. To further elucidate the clinical benefit and safety of sacubitril/valsartan, the manufacturer of sacubitril/valsartan has launched FortiHFy global clinical trials initiative. Additionally, the PARAGONHF clinical trial is currently underway
studying sacubitril/valsartan in heart failure with preserved ejection fraction (HFpEF). Sacubitril/valsartan is currently available in the U.S. in three dosage strengths: sacubitril/valsartan 24 mg/26 mg, sacubitril/valsartan 49 mg/51 mg, and sacubitril/valsartan 97 mg/103 mg. The average cost for either of these doses of sacubitril/valsartan ranges between $400 – 450 per month. The SHIFT trial evaluated the effects of Ivabradine on heart failure related hospitalization and cardiovascular mortality 6,8. Although the results for these outcomes were clinically significant, the observed effect was driven mainly by reductions in the frequency of hospitalizations 6,8. In fact, the FDA approved indication is in the risk reduction of hospitalizations due to worsening heart failure, not in the reduction of mortality risk. An additional consideration to keep in mind is that majority of patients receiving beta blocker therapy were not at the
recommended target dose 6. Ivabradine is available in the U.S. as a marketed product by Amigen. The available doses strengths include 5 mg and 7.5 mg. Patients can expect to pay an out of pocket cost around $400 for a 30 day supply. As application of these medications in the management of heart failure gains traction, the medical community will without a doubt obtain a clearer idea of how these medications fit into practice. Until such time, considerations for the use of these medications should not only be directed by guideline recommendations, but also patient specific factors and optimization of current heart failure therapies. In addition, considering that newer, innovative therapies are often more expensive than conventional therapies; insurance coverage and the patient’s financial ability to obtain these medications will also warrant consideration.
Table 1: Summary Data for Clinical Trials of Neprilysin Inhibitors in Heart Failure Study
Design
PARADIGM-HF
Randomized, controlled trial
OVERTURE
Randomized, controlled trial
Regimen
Primary Endpoint(s)
Outcome(s)
valsartan/ sacubitril 200 mg twice daily or enalapril 10 mg twice daily
Time until cardiovascular death or heart failure hospitalization
Primary endpoints reduced 21.8% treated with sacubitril/ vasartan compared to 26.5% in enalapril (P<0.001)
omapatrilate 40 mg daily or enalapril 10 mg twice daily
Combined risk for allcause mortality or hospitalizations for heart failure
Combined risk for all-cause mortality or hospitalizations for heart failure No significant difference in primary endpoint reduction between omapatrilate compared to placebo (p<0.187)
Table 2: Summary Data for Clinical Trials of Ivabradine Study
Design
SHIFT
Randomized, placebocontrolled trial
Post-hoc analysis of the SHIFT trial
Regimen
Primary Endpoint(s)
Outcome(s)
Ivabradine 7.5 mg twice daily vs. placebo twice daily
Death from a cardio vascular event or a heart failure related hospitalization
Primary endpoint occured in 24% of patients treated with ivabradine vs. 29% in placebo p<0.0001)
Randomized, placebocontrolled trial
Ivabradine 7.5 mg twice daily vs. placebo twice daily
Death from a Cardiovascular event or a heart failure related hospitalization
CV death and HF hospitalization was significantly increased with comorbidity load in both treatment groups (p<0.0001)
Ivabradine in stable coronary artery disease without clinical heart failure
Randomized, double-blind, placebo controlled trial
Ivabradine 10 mg BID or placebo
Death from a cardiovascular event or nonfatal myocardial infarction
No significant difference between ivabradine and placebo groups (6.8% vs. 6.4%; p<0.20)
BEAUTIFUL
Randomized, double-blind, placebo controlled trial
Randomized, double-blind, placebo controlled trial Ivabradine 7.5 mg twice daily or placebo
Cardiovascular death, hospital admission for acute MI or worsening heart failure
No significant reduction between ivabradine compared to placebo (p = 0.94)
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References: 1. Yancy, CW, Jessup, M, Bozkurt, B, et al., 2016 ACC/AHA/HFSA Focused Update on New Pharmacological Therapy for Heart Failure: 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. J Am Coll Cardio. 2016. 2. McMurray JJV, Packer M, Desai AS, et al. Angiotensin-neprilysin inhibition versus enalapril in heart failure. N Engl J Med. 2014; 371:993-1004. 3. Valsartan/sacubitril (Entresto) Prescribing Information. Hanover, NJ: Novartis Pharmaceuticals Corporation; 2015. 4. Packer, M, Califf, RM, Konstam, MA, Krum, H, et al. Comparison of omapatrilat and enalapril in patients with chronic heart failure the Omapatrilat Versus Enalapril Randomized Trial of Utility in Reducing Events (OVERTURE). Circulation. 2002; 106:920-926. 5. Ivabradine (Corlanor) Prescribing Information. Thousand Oaks, CA: Amgen Incorporated; 2015. 6. Swedberg K, Komajda M, Böhm M, et al. Ivabradine and outcomes in chronic heart failure (SHIFT): a randomised placebo-controlled study. Lancet. 2010; 376:875-885. 7. Swedberg K, Komajda M, Böhm, M, et al. Rationale and design of a randomized, double‐blind, placebo‐controlled outcome trial of ivabradine in chronic heart failure: the Systolic Heart Failure Treatment with the If Inhibitor Ivabra dine Trial (SHIFT). Eur J Heart Fail. 2010; 12:75-81. 8. Swedberg K, Komajda M, Böhm, M, et al. Effects on outcomes of heart rate reduction by ivabradine in patients with congestive heart failure: is there an influence of beta-blocker dose?: findings from the SHIFT (Systolic Heart failure treatment with the If inhibitor ivabradine Trial) study. J Am Coll Cardio. 2012; 59:1938-1945. 9. Böhm, M, Robertson, M, Ford, I, et al., Influence of cardiovascular and noncardiovascular co-morbidities on out comes and treatment effect of heart rate reduction with ivabradine in stable heart failure (from the SHIFT trial). Am J Cardiol. 2015;16:1890-1897. 10. Fox, K, Ford, I, Steg, PG, et al., Ivabradine in stable coronary artery disease without clinical heart failure. N Engl J Med. 2014; 371:1091-1099. 11. Fox, K, Ford, I, Steg, PG, et al., Ivabradine for patients with stable coronary artery disease and left-ventricular systolic dysfunction (BEAUTIFUL): a randomised, double-blind, placebo-controlled trial. Lancet. 2008; 372:807-816. 12. ClinicalTrials.gov. Efficacy and Safety of LCZ696 Compared to Valsartan, on Morbidity and Mortality in Heart Fail ure Patients With Preserved Ejection Fraction (PARAGON-HF). (August 8, 2013) https://clinicaltrials.gov/ct2/show/ NCT01920711?term=PARAGON-HF&rank=1 (link is external). Accessed October, 2016. 13. Packer, M, Califf, RM, Konstam, MA, Krum, H, et al. Comparison of omapatrilat and enalapril in patients with chronic heart failure the Omapatrilat Versus Enalapril Randomized Trial of Utility in Reducing Events (OVERTURE). Circulation. 2002; 106:920-926.
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