ARIZONA JOURNAL OF PHARMACY THE OFFICIAL PUBLICATION OF THE ARIZONA PHARMACY ASSOCIATION BROUGHT TO YOU BY PHARMACY NETWORK OF ARIZONA
Fall 2015
Betty Louton, PharmD AzPA President 2015-2016
Fall 2015 • Arizona Journal of Pharmacy • 1
October is American Pharmacists Month
Rx
The Arizona Pharmacy Association is dedicated to the advancement of the pharmacy profession in Arizona. In celebration of American Pharmacists Month, join us in supporting your profession. Support Pharmacy Education
The Arizona Pharmacy Foundation, a 501(c)3 non-profit provides funds for student scholarships, pharmacy research and residency programs.
Support Legislative Initiatives PharmPAC is a non-partisan voluntary committee that pools its financial resources to by supporting pieces of legislation. 2016 Legislative Priority: Immunization Expansion
azpharmacy.org/support
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THIS FALL .... BE CONNECTED. BE INSPIRED.
AzPA 2015 Fall Conference CPE SESSIONS & NETWORKING
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azpharmacy.org/Fall2015 #azpaFall
Arizona Journal of Pharmacy
THE OFFICIAL PUBLICATION OF THE ARIZONA PHARMACY ASSOCIATION BROUGHT TO YOU BY PHARMACY NETWORK OF ARIZONA
Vol. 7, No. 3
Fall 2015
In This Issue .... Message from Leadership Special contributions
4
Time Capsule Student Perspective: Annual Convention
18 14
Features
Postgraduate Residency Interviews of Current Pharmacy Practice Residents in 5 Southwestern States 15 Patient Education to Knowledge Regarding Sodium Intake For Adults Attending A Community Health Fair 19
Departments Association News New Members PAPA Legislative Update Annual Convention Recap Technician Spotlight
Academy News: • Community Pharmacy Academy • Geriatric Care Academy • Health-System Academy • Managed Care Academy • Student Pharmacist Academy • Technician Academy
5 5 7 8 9-12 13 23 23 24 24 25 25
Continuing Education: New Oral Anticoagulants: A General Overview of Dabigatran, Rivaroxaban and Apixaban 26
Advertisers PAAS Pharmacy Quality Commitment Pharmacists Life Insurance PTCB Rx Armory Rx Relief Suncrest Software
Editor www.azpharmacy.org/ajp
Kelly Ridgway, R.Ph. Chief Executive Officer
Editorial Board
Whitney Rice, Pharm.D. Christi Jen, Pharm.D. Scott Hardy, Pharm.D.
Managing Editor
22 18 39 10 18 40 2
Rachel Jimenez Marketing & Communications Director Andrea Burns, Pharm.D. Jaime Bailey, Pharm.D. Kalani Anderson, C.Ph.T.
Fall 2015 • Arizona Journal of Pharmacy • 3
Leadership Dear AzPA Members, As we begin a new year with our new Board of Directors, I thought it would be appropriate to share with you, our members, what we do at AzPA. Your Board of Directors last year developed a solid Strategic Plan for the next 2 years. This plan lays out a direction that is in-line with our mission and vision statements; these statements are the two components that the AzPA Board of Directors, Academies and Committees use to determine what projects and initiatives make sense for our organization. Everything we do is vetted against these two statements. Our convention theme this year was “AzPA Connects the Pieces of Arizona Pharmacy” and it was symbolized by a jigsaw puzzle. By looking at the puzzle you can see that there is a logical reason for each piece. Without each of them, the puzzle would be incomplete. Let me share some brief thoughts with you and then maybe you will recognize that each and every one of you has value and without each of us doing our piece we can’t complete the puzzle. Kelly Ridgway, our CEO, and her staff do a phenomenal job of being there for each of us, but it still takes more. This organization is dependent upon our volunteer leaders. We encourage our members to get involved. Increase your own awareness of your profession, and pass it on to other pharmacists, technicians and pharmacy students. This would help grow our membership, and growing our membership is part of our Strategic Plan. I would like to share with you what we do as an organization for our profession. Part of our Mission Statement says that we will foster safe and effective medication therapy, promote innovative practice, and empower its members to serve the health care needs of the public. We carry out our mission in many ways, but few are more important than political advocacy and professional development. On the political advocacy front, every year we have a presence in the state Legislature; this is important for protecting pharmacy’s right to practice in this state. We not only run our own bills, but we work to defeat bills that are harmful to pharmacy as well as support bills that are good for pharmacy and patient care. Professional development is another way that we carry out our mission: this is driven by each member of the organization. AzPA works to promote lifelong learners, and empower them to create innovative practices. We do this by developing new and challenging certificate programs and with the help of volunteers these programs foster lifelong learners. It would benefit our efforts if you would send your suggestions to the AzPA office or any Board Member for new programs that would assist you in your work environment We are going places this year, and we would like you to come with us. We have many ideas, including developing programs for Technicians, establishing a Community Outreach Committee, expanding our Mentor Connection Program, and increasing our PharmPac Committee. We need your help. We know that many members would like to volunteer for something if they had the time. We have identified several volunteer needs that can fit anyone’s time commitment. Please call our AzPA office and see if any of our needs fit your specific expertise, something you might like to try out, or just a task that fits your available time. As this new year gets underway, I urge all members to take a more active role in our state organization. It is indeed an honor to serve as President of our State Pharmacy Association. Together we can find where each of you fits in the puzzle.
Arizona Pharmacy Association
Kelly Ridgway, R.Ph. Chief Executive Officer Arizona Pharmacy Association
Betty Louton, PharmD President AzPA Board of Directors 2015-2016
ASSOCIATION NEWS Refe raM azph Tod ember ay arm acy. org/ refe r
WELCOME NEW MEMBERS (April 1 - June 31st 2015) NEW PRACTITIONER Abdallah Nawfal Abigail Roelle James Montague Kinbo Lee Maudlyn Mary Aladi Fariborz Ghafoori Megan Dill Zafer Genc ASSOCIATES Rene Johnson Garrick Sakado Sandra Boulos Stacey Wisman
PHARMACISTS Makini Alleyne Nathan Temme Russ Newman Sharon Wadhams Tanisha Curtis Heather Balk Jerome Hayes Marcia Swinford Aaron Middleton Christopher Pucillo Davy To Jeannie Hong Jon Morris
Lyle Trone Marilyn Myers Michele Heuer Pearline Dillard Stacey Hollen Stephanie Kennedy RESIDENTS David Odabashyan Khoa Truong Jeffrey Boyer Joe Mauro Nickolas Vamianakis
STUDENTS Pamela Griffin Yelena Gapchenko Amanda Al-Said Erin Hohenstein Jeffrey Jones Alexandra Chambers Cadmus Kyrala Charles Westfall Meghan Reen Min Yang Samuel Felix Kate Van Hassel
TECHNICIANS Eve Hernandez Mercy Koshy Aeryana Beaudrie Cheryl Emrie Lourva Begay Debra Counts
NEW MEMBERS: Visit your Member Center to learn how to get more involved with AzPA. Located on www.azpharmacy.org homepage.
Cheers for Volunteers!
We acknowledge the contributions of the volunteers who have made a difference for our organization. The individuals helped make the 2015 Annual Convention a success as a speaker, student volunteer or planning committee member. Thank you for your continued support of the pharmacy profession. Gina Gries JT Simonsen Grace Akoh-Arrey Mika Jankowski Cole Sloan Ohoud Aljuhani Daniel Jarrell Wendy Toler Seth Anderson Christi Jen Laura Tsu Sally Armstrong William N. Jones Valerie Valdiviez Danielle Backus Amy Kennedy Holly Van Lew R. Michelle Baker Marilyn LaBash Terri Warholak Kevin Boesen Heather Leinbach Dean Wright Mark Boesen Robert Lipsy Bradley Young Valerie Bostel Monica Malapit Mindy Throm Burnworth Evan Mallory Paris Cook Kelly Mathews Janet Cooley Ali McBride Justin Cossette Grant Metcalf Kim Christoff Shannon Metzel Jessica DiLeo Roger Morris Heidi Ann Ecker Nicole Murdock Joseph ElAshkar Sarah Nguyen Martha P. Fankhauser Elizabeth Pogge Sam Felix Carol Rollins Sophia Galloway Andrew Sam Jon Glover Ann Sears Jeff Gray
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.
Stay connected!
Arizona Pharmacy Association
Advancing Pharmacy to Improve Healthcare
Fall 2015 • Arizona Journal of Pharmacy • 5
Mentor Connection Program
Arizona Pharmacy Association
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 adversiting. SNEAK PEEK AT CURRENT OPENINGS Staff Pharmacist ------------------Network Contract Pharmacist ------------------
Cardondelet Health Jackson Pharmacy
azpharmacy.org/jobs
SAVE THE DATE: AzPA 2015-2016 Events September 25: APhA Deliverying MTM Services, Women’s Reproductive Health, Anticoagulation Certificate Programs (Register Today)
September 26: 2015 Fall Conference (Register Today) November 6th: APhA Pharmacy-Based Cardiovascular Disease Risk Management Certificate Program (Glendale) March 22nd: 2016 Pharmacy Day at the Capitol (Phoenix) June 9th: Certificate Programs (Chandler) June 10th: 2nd Annual AZ Residency Conference (Chandler) June 10-12th: AzPA 2016 Annual Convention (Sheraton Wild Horse Pass Resort, Chandler, AZ)
azpharmacy.org/events Association News
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 You’re Invited Join an AzPA Committee Legislative Committee
Chair: Mark Boesen Meetings held 1st Wed of the month at 12pm
Membership Committee:
Chair: Amy Leung Co-Chair: Kristyn Straw-Wilson Meetings held 2nd Wed of the month at 3pm
Continuing Education Committee:
Co-Chairs: Nicole Scovis & Lindsay Davis Meetings held 2nd Thurs of the month at 3pm
Communications Committee:
Chair: Whitney Rice Meetings held 3rd Wed of the month at 12pm
Visit azpharmacy.org/committees for more information
Pharmacists Assisting Pharmacists of Arizona (PAPA) by Ryan G. I used to consider my childhood and upbringing reasonably normal being the middle child in a large Midwest family. My parents struggled through raising children, paying bills and maintaining sanity but I knew they always loved me. I knew from an early age that addiction and alcoholism ran rampant through my family tree however. I can remember feeling like I never really fit in. I wasn’t an older sibling nor was I like the younger two. I didn’t feel like I fit in with my two brothers, having moved on from action figures and legos before they had, or two sisters for obvious reasons. To make matters worse, my two best friends were twins with whom I always felt like the odd kid out. The anxiety of not fitting in only became worse from grade school through high school. I was the picked on kid and recess and sleepovers were never ending opportunities for ridicule. I learned quickly that overachieving in either athletics or schoolwork was my easiest pathway to gaining attention and feeling worthwhile. I started drinking in college in order to finally fit in. I drank for this specific effect from the first sip through my last hangover. The wreckage started quickly thereafter too. I found myself ticketed for consumption as a minor, trying other substances, and I dropping out of school. Joining the army was my solution but I soon found that my drinking only got worse. I ended up in more legal trouble with a DUI and returning from each deployment was just like a relapse for me. I started pharmacy school after my last deployment. My first 6 months of school were a train wreck outside of the classroom even though I could maintain my grades. I could not get enough of alcohol and drugs. Purposefully overzealously, celebrating finals week led to my arrest for possession and I literally thought my life was over. I met with school officials after disclosing the incident and discussed treatment and monitoring which were both entirely new concepts to me. Being afraid of my pending charges, I found a job out of town working construction and tried to earn money to pay for my fees and fines. I kept drinking. I would still wake up in the morning wondering how and why I could not control my life and my drinking. I was still a mess. I moved home to start rehabilitation about six months later. I joined PAPA, started an intensive outpatient program and learned about addition. In the beginning, I only planned to stay clean and sober for 5 years to make the program happy and keep my license. I promised myself to be open and honest throughout the rehab process and one day I heard a line stating some people If you or someone you care about self-medicate through drugs, alcohol, gambling, risk-taking, sex, is suffering from an alcohol and/or shopping, novelty, electronics, etc. This was a pivotal moment for chemical dependency problem... me because I didn’t drink every day or use every day but I definitely did one of these things every day to feel different. I did not like ...help is available. the person I had become and ‘needed’ to self-medicate. Pharmacists Assisting Today, after 4.5 years of giving myself to my Recovery, my life has completely reformed itself. I am actively exploring my personPharmacists of Arizona al spirituality. I happily attend and participate in 12-step meetings. “A Partnership in Caring” I do my best to share my experience with others trying to recover. Contact the AzPA Office at 480.838.3385 or I graduated pharmacy school and completed my PGY-1 residency. papa@azpharmacy.org Later this summer I will be sharing my experience at my fraterAll calls confidential. Caller remains anonymous. nity’s national convention. However, the best gift recovery has given me is my family. My girlfriend stuck with me through the PAPA struggles immediately following my arrest; through the emotional is a program of the Arizona Pharmacy Foundation rollercoaster of early recovery and today I am proud to call her my lovely wife. Today, we have chance at a fairy tale ending, one day at a time. Fall 2015 • Arizona Journal of Pharmacy • 7
LEGISLATIVE UPDATE 2015 Legislative Session (AzPA Priority) MEDICATION SYNCHRONIZATON: PASSED 2015
Refers to the process of a pharmacy coordinating all of a patient’s chronic prescription medications to be filled on the same date each month. In order to achieve this, the pharmacist initially performs a comprehensive review of the patient’s medication regimen to determine the appropriateness of each therapy and the patient receives a personal call each month to review their medications prior to filling them to ensure no changes have been made and to confirm the patient is still taking the medication.
AzPA also supported: HB2495/SB1194 Loan Repayment - PASSED
AzPA participated in stakeholder meetings in the fall of 2014 on the bill and supported HB2495/SB1194 throughout the legislative process. The bills expand the types of medical professions (to include pharmacists) that can participate in the Primary Care Provider Loan Repayment Program and the Rural Private Primary Care Provider Loan Repayment Program.
SB1370 Controlled Substances - PASSED
AzPA attended stakeholder meetings early in the legislative session to work on several different bills meant to expand the use of the PMDB. The goal was to ensure that all prescribers have their info sent to the Board of Pharmacy when their licenses are renewed so they are added to the list of providers that may access the PMDB. They would also repeal the requirement that the authorization be re-secured every 2 years.
HB2322 Misbranded Drugs - PASSED
As introduced, HB2322 (misbranded drugs) included several AzPA requested amendments, with the exception of language to clarify that a drug or device is not considered misbranded if it was mislabeled or incorrectly filed due to a filing error.
All AzPA members are welcome to attend the monthly meetings. If you are interested in joining the discussions, contact Mark Boesen, Legislative Committee Chair at legislative@azpharmacy.org or Kelly Ridgway, AzPA CEO at kelly@azpharmacy.org
Looking Ahead: 2016 Legislative Session IMMUNIZATION EXPANSION:
In 2009, legislation was enacted permitting pharmacists to immunize adults 18 years and older without a prescription. However, Arizona pharmacist are still limited in their ability to immunize children ages 6-17, requiring a prescription order for all vaccinations except influenza. The need for children ages 6-17 to have a prescription order for any vaccination, other than influenza, is a significant barrier to improving vaccination rates. AzPA is supporting a legislative initiative to expand Arizona pharmacists’ immunization abilities.
Help support the Immunization Expansion Initiative. Contribute to the Pharmacists Political Action Committee of Arizona (PharmPAC). www.azpharmacy.org/PharmPAC Other issues of concern: Fair Audit & Generic Pricing
Well over 30 states have passed legislation to create standards for pharmacy audits. These statues create, among other things: notice requirements; establish periods of time such audits can go back; prohibit “extrapolation” (assuming an error rate for a small audit sample applies across all prescriptions and thus rescinding payment). Maximum Allowable Cost (MAC) pricing is the methodology payers use to reimburse network pharmacies for generic drugs. Payers often times do not use uniform methods or criteria for updating MAC prices.
Residency PGY2 Reciprocity
Currently PGY2 residents coming to Arizona can only apply for reciprocity after being licensed in another state for one year. This causes a delay in their ability to participate in direct patient care. AzPA is looking to change the requirement of reciprocity to six months instead of one year.
Mark Boesen AzPA Legislative Affairs Committee Chair legislative@azpharmacy.org Jeff Gray, Axiom Public Affairs AzPA Lobbyist
AzPA 2015 Annual Convention Recap
Our annual meeting was a success. We were joined by pharmacists, pharmacy technicians, pharmacy residents and pharmacy students from all over the state of Arizona.
AzPA Connects the Pieces of Arizona Pharmacy
Thank you to our Sponsors.
Your support helps advance the pharmacy profession.
By the Numbers: (Friday - Sunday) 350 Attendees 45 Exhibitors 31 CPE sessions 4 Legislative Reps Together, we raised over $7,500 to support PharmPAC!
We ran to support pharmacy education! 30 Participants APF 5K Fun Run June 28th Fall 2015 • Arizona Journal of Pharmacy • 9
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AzPA 2015 Annual Convention Award presentations, AZ Legislative Update,
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CONGRATULATIONS TO ALL AWARD RECIPIENTS 1. Distinguished Young Pharmacist of the Year - Jessica DiLeo, Pharm.D Sponsored by Pharmacist Mutual Companies 2. Generation Rx Champions Award - Eric Nelson, MS Pharm, Sponsored by Cardinal Health 3. AzPA Fellows (Left to right): Brian Erstad, Pharm.D., BCPS, MCCM, FCCP, FASHP; Robert Lipsy, PharmD, FASHP, BCPS; Lindsay Davis, PharmD, BCPS
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4. AzPA Exemplary Patient Care Award - Grace Akoh-Arrey, PharmD, CDE, BCACP, CDTC 5. Jennifer Lechner, CPhT, Technician of the Year Award 6. Bowl of Hygeia - Tom Van Hassel, RPh. His daughter received the award on his behalf. Sponsored by Boehringer Ingelheim 7. Excellence in Innovation - Martha Fankhauser, MS Pharm. Sponsored by Upsher-Smith Laboratories, Inc.
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8. Pharmacist of the Year Award - Nicole Scovis, PharmD, BCACP, BCPS
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9 & 10. Pharmacy Appreciation Awards (Left to right): Valerie Bostel, PharmD; Gina Gries, PharmD, BCPS; Jessica DiLeo, PharmD; Joseph R. Gill, C.Ph.T.; and (not pictured) Tony Rondinella, PharmD 11. Corporate Appreciate Award: SinfoniaRx Pictured Kevin Boesen, PharmD, FAzPA, Founder and CEO of SinfoniaRx; and Kelly Ridgway, RPh, FAzPA, AzPA CEO 12. AzPA Hall of Fame Award - Robert Lipsy, PharmD, FASHP, BCPS; and (not pictured) Sandra Leal, PharmD, MPH, FAPhA, CDE
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13. Lifetime of Service Award - Hal Wand, RPh 10.
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June 25-28th Recap 1st AZ Residency Conference, Exhibit Hall, Student Track & More Student Track Thank you to the following individuals for participating as an Adopt-A-Student sponsor. Your contribution enabled a pharmacy student participate in Convention activities. Thomas Batik Whitney Rice James Chase Althea Alderson Kris Kaniski Nicolas Hiner Virginia Boomershine
The Student Track included mock interviews / CV reviews
Thank you to Senator David Bradley, Representative Bruce Wheeler and Christina Corieri (Policy Advisor for the Office of the AZ Governor), for joining us to discuss Arizona Health Care Legislation, Sunday June 28th. (Pictured with Express Scripts representatives, Jeff Gray (AzPA Lobbyist), and Kelly Ridgway, AzPA CEO)
Celebrating the Past Presidents of AzPA
Exhibit Hall
Thank you to the following exhibitors for making it a successful tradeshow.
Abbott Diabetes Actavis Albertson’s / Safeway American Regent AmerisourceBergen Arizona Smoker’s Helpline Arkray AstraZeneca Diabetes AstraZeneca LLP Banner Health Boehringer-Ingelheim Bristol Meyers-Squibb Cardinal Health Cubist Pharmaceuticals CVS Health Express Scripts Freedom Pharmaceuticals Fresenius Kabi USA Fry’s Pharmacy Germfree Grifols USA Humana Kit Check Liberty Software Lilly USA McKesson Meda Pharmaceuticals Merck Vaccine Midwestern University COP Novo Nordisk Pfizer Pharmacist Mutual Companies PharMEDium Precision Toxicology Premier Thera-Doc Pharmacy Technician Certification Board Roche Diabetes Rx Plus Rx Relief Sanofi Sunovion Teva Respiratory University of Arizona COP Walgreens
Fall 2015 • Arizona Journal of Pharmacy • 11
AzPA 2015 Annual Convention June25-28th @AzPharmacyAssociation Download your favorite pics
AzPA’s new 2015-2016 Board of Directors looks forward to another great year.
Arizona Pharmacy Association
Save the Date: AzPA 2016 Annual Convention June 9-12, Sheraton Wild Horse Pass Resort (Chandler)
TECHNICIAN SPOTLIGHT Justin Klasky - The Compassionate Fan Favorite by Kalani Anderson, CPh.T
When Justin Klasky sat down in 2011 at his new job at the University of Arizona’s Medication Management Center in Tucson, AZ, he felt lost. He was grateful for the job and for the people who had provided him this opportunity, but as a tech in training, he had no previous experience in the pharmacy industry. He had a Bachelor’s Degree from the U of A in Political Science and experience working in Real Estate, but those experiences had never taught him how to pronounce words like rosiglitazone or to look for potential drug interactions in an aging patient population. Pharmacist Jim Kloster recalls, “I noticed Justin one day during his first week. He looked very uncomfortable. I introduced myself and talked to him. He had limited experience in pharmacy and was not confident in himself. I had an empty spot next to my work station and set it up so he could sit there. I observed him as he worked and gave him feedback. He readily accepted this feedback and progressed. We worked on pronunciation of medication names on meds he was not familiar with. We also worked on limitations of information which Technicians can provide versus Pharmacist. As he gained confidence Justin began to enjoy his job. He loves helping people and is an effective technician for us.” While his previous education and experience had not taught him to pronounce drug names or to navigate the ins and outs of a pharmacy, they did provide him with a great education in how to work with people. Perhaps it was this background along with the challenges he overcame in learning about pharmacy that have earned him so many positive comments and reviews from patients. Martin Pelger, a Lead Pharmacist at the MMC, stated that “Justin’s greatest strength is his engaging personality which makes him a ‘fan favorite’ here at the MMC. We constantly get feedback from patients stating what a joy it was to talk to Justin. This makes the job a lot easier for our interns and pharmacists when they get a transfer from Justin. Happy patients are more fun to talk to and they are more receptive to the information we share with them. Our clients enjoy hearing that their patients are happy, too.” In April 2012, Justin was able to sit for the Pharmacy Technician Certification Exam and credits his mentors at the Center for training him so well that he was able to pass the exam with flying colors. Shortly after he started work as a technician, he also became aware that the MMC reimburses its technicians for membership in
AzPA. He gladly took advantage of that benefit and appreciates access to quality continuing education. He also recalls an early experience in his career where he was trying to figure out how to renew his technician license and registration for the first time. New to the process, he decided to call AzPA’s office staff for help. While licensing technicians is the job of the Board of Pharmacy rather than AzPA’s staff, the individual with whom Justin spoke took the time to walk him through the whole process and make sure he was comfortable with what he needed to do. Experiences like that have inspired Justin to become the compassionate technician he is today. This compassion extends beyond the workplace where he volunteers with his church’s youth group and also serves as lector. He also finds time in his schedule to help out at the local Animal Humane Society and Pit and Proud, two non-profits where he gets the chance to take dogs for walks, help with events, and more. He is proud of his own rescued pit bull named Itch who is like family (pictured). When asked for his advice on successful traits of a strong pharmacy team, he readily gives examples of his current work place where he is very happy. Pharmacists and technicians who are willing to help each other answer questions and who are there for the benefit of the patients they serve make the difference between a business and a pharmacy. To anyone who wants to be a successful and good technician, Justin proffers this advice: “Try and treat every patient how you’d want your Grandma to be treated. Any job can become routine. But every patient deserves respect and patience. They’re a human being with a family.”
Pharmacists Say it Best … Certification Excellence “The smooth and efficient operation of today’s pharmacy requires the expertise of a Certified Pharmacy Technician. When considering to hire someone, I look for the familiar PTCB CPhT. When I see that initiative, I know that the applicant has, at a minimum, the basic knowledge to meet the needs of my department.”
Since 1995, the Pharmacy Technician Certification Board (PTCB) has certified over 400,000 technicians nationwide and is the only pharmacy technician certification program endorsed by the American Pharmacists Association, the American Society of HealthSystem Pharmacists, and the National Association of Boards of Pharmacy.
Do it for your pharmacy. Do it for your patients. Do it for you. Encourage your technicians to become certified today! Candidates may apply to take the Pharmacy Technician Certification Exam online at www.ptcb.org.
—Laura Forbes, RPh, Director of Pharmacy Services, Gov. Juan F. Luis Hospital and Medical Center, Christiansted, U.S. Virgin Islands CONNECT ONLINE:
Fall 2015 • Arizona Journal of Pharmacy • 13
Student Perspective AzPA Annual Convention: My first experience and new tradition
by Becky Lu, Pharm. D. Candidate, Midwestern University College of Pharmacy - Glendale, Class of 2016 The decision to attend the AzPA Annual Convention for the first time opened many opportunities and invoked inspiration to become more involved. I decided to attend this year’s annual convention from the recommendation of professor, Dr. Mindy Burnworth, who advised that it would be a great event for me to learn more about the diversity of Pharmacy and options for involvement. To say she was right, is an understatement considering the magnitude opportunities that the convention provided. The weekend had an abundance of amazing presentations, networking opportunities, and new insight into the world of pharmacy; it provided a great first step into learning about the programs devoted to student involvement and learning. The meeting was held at The Westin La Paloma in Tuscon, which offered beautiful views of the mountains and lovely amenities. After exploring the resort, the first event I attended was the Midwestern University Dessert Reception where I had valuable discussions with professors and peers. There were also other attendees outside of Midwestern, some of whom were pharmacists I had met during my IPPE rotations my first year and had the chance to re-connected with. One of the first events I attended hosted by the Student Track Planning Committee was the Lightening Rounds of Clinical pearls organized through the hard work of the student committee and guidance of Dr. Gina Gries. The session has been very popular with both students and other convention attendees since it started two years ago and provides a wonderful opportunity for students to gain public speaking confidence and teach their peers about a number of different topics. Presentations on clinical pearls with titles such as ‘Clonidine: Not your usual suspect’ and on topics such medication use in the pediatric population, produced thought provoking discussions and an overall educational experience. I was extremely proud of my peers after seeing their amazing presentations that showcased their hard work and passion in their topics. The poster presentations and Exhibit Hall were next on my list of events to attend. The plethora of different topics presented there reflected on the diversity of pharmacy practice. Presentation topics ranged from complementary and alternative medicine (such as Willow Bark as an alternative to Aspirin) to disease management in the ICU (such as the use of acid reducers in stress ulcer prophylaxis). I then explored the Exhibit Hall (shout out to one of my peers Joe Elashkar who did a great job as the emcee) where I grabbed a delicious lunch and networked with a vast number of pharmacy programs. As I was visiting each booth, I stopped by the AzPA Mentor Connection Program where I learned about its 10-month program that pairs student pharmacists and practicing pharmacist. I had been searching for a program like this previously; needless to say, I eagerly signed up and am looking forward to participating! Next on my agenda was the Mock Interview Session. This event provided students a chance to hone their interviewing skills and receive feedback on their CV’s. Students were able to participate in at least two interviews and gain valuable advice from their interviewer. Many students later remarked that the event was tremendously useful and they overall took a lot away from the experience. Not only did I take away the valuable one-on-one interaction with accomplished pharmacists; I also had the pleasure of meeting a pharmacist who agreed to work with me on future projects to better prepare me for residency applications. I felt fortunate for this opportunity as it also opened up different doors for participation, such as the opportunity to write for this journal! The Student Track Planning Committee put a lot of time and effort into our programming so I would like to thank those involved for their hard work. I am certain a lot of those who attended the convention would agree that their efforts in providing students quality educational programming was exceptional and afforded a lot of value into those who participated in the events. AzPA gives students opportunities for leadership, educational programming, and mentorship. As a student attending my first Annual Convention, I felt welcomed and inspired. The values from my personal experience empowered me to become more involved and to make AzPA’s tradition of hosting a convention every year my own. Now I feel compelled to recommend this conference to more of my peers just as Dr. Burnworth did for me.
FEATURES Determination of Characteristics associated with Postgraduate Residency Interviews of Current Pharmacy Practice Residents in 5 Southwestern States by Andrew Sam, Pharm.D. Candidate, Sarah Nguyen, Pharm.D. Candidate, Laura Tsu, Pharm.D., BCPS, CGP, Nicole K. Early, Pharm.D., BCPS, CGP Introduction Since 2003, the number of applicants participating in the American Society of Health-System Pharmacists (ASHP) Resident Matching Program has outpaced the number of pharmacy postgraduate year 1 (PGY1) positions available.1 Although the number of accredited PGY1 programs is increasing each year, the demand for PGY1 positions has not been met. From 2010 to 2015, less than 65% of applicants matched to a PGY1 program despite an increase in programs each year.2 Due to the overall competiveness of matching with a PGY1 program, applicants must seek to attain many qualifications and experiences in order to increase the likelihood of getting an interview and ultimately matching with a program. Students must utilize their time wisely in pharmacy school and develop a well-rounded curriculum vitae (CV). Fortunately, studies have shown that qualifications like grade point average (GPA), hospital work experience, leadership, and publications are highly valued by residency program directors (RPDs).3-5 While these studies have shown which qualifications and characteristics are highly sought by RPDs, students may have trouble identifying which qualifications and characteristics are most beneficial in acquiring a specific type of residency. There is a wide variety of options for postgraduate training including programs focused on ambulatory care or acute care. These programs are also based in different types of medical centers, including veterans affairs, academic medical centers, and community hospitals. There are also community pharmacy residency programs that are often run by independent pharmacies or retail chains. The purpose of this study is to assess whether there are certain characteristics that lead to specific types of residency program interviews. Acute care residency interview statistics will be directly compared to ambulatory care residency interview statistics. At the same time, we will also see if there are geographic differences in qualifications and characteristics in the 5 states sampled.
FEATURES
Methods This was a cross-sectional survey study of PGY1 pharmacy residents located in 5 southwestern states: Arizona, California, New Mexico, Nevada, and Utah. The PGY1 pharmacy residents were identified using the ASHP’s database on residency programs, which either contained a link to the residency program’s website and/or the residency program director’s contact information. If the PGY1 pharmacy resident’s contact information was not included in the program’s website, then the residency program director was contacted via email in order to obtain the residents’ contact information. The PGY1 pharmacy residents were then contacted via email and prompted to complete an electronic survey. Two email reminders were sent out 1 week apart in order to encourage participation. The survey contained 37 questions that assessed the resident’s demographics and application statistics, which included: GPA, research experience, publications, presentations, leadership positions, type of work experience, awards received, and letters of recommendation. Following this section, participants were asked to indicate the number of interviews they received and information about each interview including: the state of the interview, type of residency program, and relative size of the hospital if applicable. This research was conducted in compliance with Institutional Review Board requirements. Results Between October 2014 and November 2014, a total of 169 PGY1 pharmacy residents located in Arizona, California, New Mexico, Nevada, and Utah were contacted to complete the survey. Of those 169 residents, a total of 52 completed responses were recorded. This represents a 30.7% response rate among the residents sampled.
Fall 2015 • Arizona Journal of Pharmacy • 15
12
52
Female sex – No. (%)
41 (79%)
Median age range – years
26 – 30
Average No. of residency applications
8.54
Average No. of interviews received
5.75
Percentage of applicants from pharmacy schools in either California or Arizona
70%
10 NUMBER OF APPLICANTS
Total number of responses
8 6 4 2 0 2.51 - 3.00
3.01 - 3.25
3.26 - 3.50
Acute Care
Table 1: Baseline characteristics of respondents.
Acute care vs ambulatory care interviews Of the 52 complete responses, 27 of the responses indicated that they received an interview from an acute care PGY1 program while 19 responses indicated that they received an interview from an ambulatory care PGY1 program. The overall GPA of residents receiving an interview for either ambulatory care or acute care programs ranged from 3.01 – 4.00 as reported in Figure 1. While GPAs varied across this range, a majority of the responses came on the tail end of the range, from 3.51 – 4.00. When comparing qualities and characteristics of residents receiving an acute care or ambulatory care interview in Figure 2, both groups reported at least 80% in the following categories: received an award, held a leadership position while in pharmacy school, and had pharmacy related work experience. On the other hand, less than 32% in both groups had presented a poster at either the state or national level. When comparing both groups head to head in Figure 2, ambulatory care applicants reported a slightly higher rate in 4 qualification categories (received an award, held a leadership position, research experience, and publications), while acute care applicants had higher rates for two other categories (presentation on the state and national level). Both groups reported 100% in pharmacy related work experience. Geographical differences When taking geographical differences into consideration, a total of 29 respondents reported interviews from California, 17 from Arizona, and 17 from other states. These responses take into account applicants that applied to PGY1 programs in different states. As such, their responses can fall into more than 1 state. When FEATURES
3.51 - 3.75
3.76 - 4.00
Ambulatory Care
Figure 1: GPA ranges for acute care and ambulatory care interviews.
comparing the responses, the top 3 qualities and characteristics indicated are: received an award, held a leadership position, and had pharmacy related work experience. Responses from those that received an interview in California held an edge in the following 3 categories: holding a leadership position, having pharmacy related work experience, and state level poster presentation over the two other groups. Responses from those that received an interview in Arizona reported higher numbers these 4 categories: received an award, research experience, publications, and national level poster presentations. Applicants receiving an interview from states other than California or Arizona followed the same trends as the two largest states represented in this survey, albeit at a lower percentage in many of the categories surveyed.
Received An Award (School/Regional/National) Held A Leadership Position Pharmacy Related Work Experience Research Experience Publication State Level Poster Presentation National Level Poster Presentation 0 Acute Care
10
20
30
40
50
60
70
80
90
100
Ambulatory Care
Fig. 2. Percentages of acute care vs. ambulatory care respondents that possessed specific characteristics on their curriculum vitae.
Discussion In this survey of residents located in Arizona, California, Nevada, New Mexico, and Utah, we found that the top 3 characteristics that acute care or ambulatory care applicants had were: received a pharmacy-related, regional, or national award, held a leadership position in pharmacy school, or had pharmacy related work experience. All ambulatory care applicants had these three characteristics while acute care respondents had a slightly lower percentage in receiving an award and holding leadership positions. Receiving an award in pharmacy school indicates that the applicant has been recognized for their work and achievement during pharmacy school. This provides some form of validation that the applicant has produced outstanding work during their time in pharmacy school. Holding a leadership position in pharmacy school also had greater than 90% representation in both groups. Leadership is important in pharmacy residency as one of the purposes of PGY1 residencies as indicated by ASHP is to further the development of leadership skills that is applicable to any practice setting.6 Having pharmacy related work experience speaks to the applicants ability to handle pharmacy workload. These three qualities were demonstrated in the vast majority of applicants. Therefore, pharmacy students should be encouraged to demonstrate these three qualities as there is an association with receiving interviews. Research experience, publications, and presenting posters were not reported in as high numbers as the top 3 categories. Research experience is very valuable going into a PGY1 residency as it is a requirement for completion of an ASHP pharmacy residency. Having experience in selecting a topic, developing an institutional review board proposal, and writing a manuscript should prove beneficial. Presenting a poster highlights the applicant’s ability to verbalize and provide educate to an audience. Since these categories were not as well represented by applicants in this survey, there may be an avenue for future pharmacy students to gain an edge in receiving an interview in this increasingly competitive environment. Limitations for this study include the response rate, 30.7%, which may indicate non-response bias. In addition to the low response rate, acquiring resident contact information in the 5 states was not complete due to lack of information provided online and lack of responses from RPDs. Out of roughly 400 residents per FEATURES
year in these 5 states, a total of 169 residents were contacted. This, along with low response rate, may limit generalizability. Another limitation includes the fact that there are applicants that may have received interviews in these five states that either did not match or matched to a program outside of these 5 states. Conclusion In an environment where pharmacy postgraduate training is highly competitive, pharmacy students must develop their CV so that they are successful in being granted interviews. The top three qualities and characteristics identified by this survey of residents are: receiving an award, holding a leadership position, and having pharmacy related work experience. Students should aim to have these qualities represented on their CV as it is associated with being granted interviews from PGY1 residency programs. While research experience, publications, and presenting posters were not reported as frequently by residents sampled, they may be vital in gaining an edge come interview season. Received An Award (School/Regional/National) Held A Leadership Position Pharmacy Related Work Experience Research Experience Publication State Level Poster Presentation National Level Poster Presentation 0 Other States
10
20
Arizona
30
40
50
60
70
80
90
100
California
Fig. 3. Percentages of Arizona, California, and other states respondents that possessed specific characteristics on their curriculum vitae.
References 1. American Society of Health System Pharmacists. ASHP Accreditation Services Division Handout 2013; 2013. http:// www.ashp.org/DocLibrary/MemberCenter/NPF/Mod-3-Accreditation-Services-Division-Slide-Handout-VRV2013.pdf. Accessed April 12, 2015. 2. American Society of Health System Pharmacists. ASHP resident matching program. 2015. https://www.natmatch.com/ ashprmp/aboutstats.html. Accessed April 12, 2015. 3. Golhke AL, Ray DB, El-Ibiary SY, Barletta JF. Characteristics of the ideal postgraduate year 1 pharmacy practice residency candidate: a survey of residency program directors. J Pharm Practice. 2014;27(1):84-8. 4. Jellinek-Cohen SP, Cohen V, Bucher KL, Likourezos A. Factors used by pharmacy residency programs to select residents. Am J Health Syst Pharm. 2012;69(13):1105-1106. Fall 2015 • Arizona Journal of Pharmacy • 17
5. Ensor CR, Walker CL, Rider SK et al. Streamlining the process for initial review of pharmacy residency applications: an analytic approach. Am J Health Syst Pharm. 2013;70(19):1670-5. 6. American Society of Health System Pharmacists. ASHP Accreditation Services divison PGY 1 standard. http://www.ashp.org/ DocLibrary/Accreditation/ASD-PGY1-Standard.aspx. Accessed April 12, 2015.
Pharmacy Time Capsules Third Quarter 2015 1990 - Twenty-five Years ago: • 139,765 people in the United States have HIV/ AIDS, with a 60 percent mortality rate. • 74 colleges of pharmacy in US 1965 - Fifty Years ago: • The Recombinant DNA Advisory Committee approved the first experiments involving transfer of human genes for therapeutic purposes. Treatment was initiated on September 14 in a 4-year-old girl with adenosine deaminase deficiency.
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1940 - Seventy-five Years ago: • 12.7% of pharmacy sales were for prescription items. • The average prescription price was $0.93. 1915 - One Hundred Years ago: • Mary Mallon, known as Typhoid Mary, arrested and returned to quarantine after spending five years evading health authorities and causing several further outbreaks of typhoid. 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.
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Utility of Patient Education to Enhance Knowledge Regarding Sodium Intake For Adults Attending A Community Health Fair By Quan Pham, CPG Pharm.D. Candidate 2015, Bac-Ai Dong, CPG Pharm.D. Candidate 2016, Zachary Segerman, CPG Pharm.D. Candidate 2016 Preceptor: Lindsay E. Davis, Pharm.D., BCPS, FAzPA, Assistant Professor, Midwestern University, College of Pharmacy - Glendale Primary objective: The goals of this research were to assess the public’s general knowledge about sodium consumption and the utility of a concise presentation in enhancing knowledge and promoting a reduction in daily sodium intake. Methods: The intervention consisted of a pre-survey, 10-minute PowerPoint presentation, and post-survey. The surveys included questions to assess the initial and enhanced knowledge about sodium consumption, a value judgment regarding personal sodium intake, and the likelihood of modifying sodium intake (post-survey only) of the general public at the Glendale Adult Center during a health fair facilitated by student pharmacists. Results: Thirty-two participants enrolled in the study; 27 individuals completed both the pre- and post-surveys. The average pre- and post-test scores for the knowledge components were 68.5% (2.74/4) and 86.1% (3.44/4), respectively. A Wilcoxon signed rank test of the knowledge component of the pre- and post-surveys provided a mean percentage improvement of 17.6% (p=0.001). Conclusion: A student-pharmacist led presentation enhanced the public’s knowledge on sodium intake. A counseling session improved awareness of the appropriate level of sodium intake, consequences of over-consumption and specific implementations for intake reduction. Actual patient lifestyle changes were not assessed in this study, but a deficit in knowledge was addressed, allowing for improved patient choice and outcomes. Applicability to pharmacy practice: Increased sodium intake is directly correlated with an increase in mean arterial pressure (MAP), resulting in an increased risk of cardiovascular diseases (CVD) including stroke, acute coronary syndrome, and heart failure. CVD is a leading cause of death in the United States. The 2014 8th Joint National Committee recommends sodium restriction as an important lifestyle modification. According to FEATURES
the Center for Disease Control (CDC), if all patients consumed less than one teaspoonful (<2,300 mg) of sodium, hypertension incidence would decrease 25%. Pharmacists and student pharmacists have the opportunity to impact CVD and its sequelae by educating patients on how to reduce sodium intake. Introduction Sodium over-consumption is rampant in the United States with the average American consuming over 3,400 mg of sodium daily.1 The link between sodium and hypertension, the “silent killer,” is well known. The CDC estimates that 1 in 3 U.S. adults (~ 68 million people) has hypertension.2 Sodium over-consumption is associated with increased MAP, which correlates with increased risk of heart disease, stroke, and kidney injury.3 As a result, organizations such as the Eighth Joint National Committee (JNC8) have published guidelines promoting sodium restriction to <2,300 mg/day.4,5 Sodium reduction can decrease morbidity as well as reduce health care cost through drug sparing and reduced hospitalizations.2,3,6,7,8 We designed a study to assess the initial level of public knowledge regarding appropriate sodium consumption and to measure knowledge enrichment about sodium after participating in a short presentation. The questions in the survey asked the subject to assess whether or not their sodium intake was within FDA established guidelines, the maximum recommended amount of sodium consumption, the subject’s ability to read a food label, and their ability to rank the sodium content of foods in a very general hierarchy (e.g., canned, frozen, fresh foods). Methods Participants attending a health fair at the Glendale Adult Center on April 23, 2014 completed a pre-test and post-test survey after listening to a 10 minute oral or poster presentation regarding Fall 2015 • Arizona Journal of Pharmacy • 19
sodium consumption. The presentation was administered in groups of 1 to 4 participants. Before listening to the presentation, participants agreed to partake in the study and completed a pre-survey (figure 1). The presentation was a 16-slide PowerPoint slide show. It contained general information about sodium, recommended daily intake (RDI), an example “day-inthe-life” of sodium consumption, and tips regarding dietary sodium reduction. The poster presentation included the same information as the PowerPoint slide deck. The poster also had an interactive game portion. The game asked participants to guess the sodium content in a serving of food pictured. After guessing, the presenter flipped the card to reveal the actual amount of sodium and a pictured alternative with lower sodium content as an easy replacement (e.g., switching hot pockets for lean pockets, cheddar for mozzarella cheese, V8 for naked juice) (figure 2). The pre- and post-survey questions assessed awareness of sodium consumption recommendations in the participants, focusing on personal qualitative estimation of sodium intake, the FDA specified dietary reference intake (DRI), ability to triage foods based on their sodium content, and the individual’s willingness to change his/her diet. At the completion of the post-survey, participants were given a ticket to enter into a drawing for a blood pressure monitor worth approximately $30. Data analysis of participants’ matched pre and post-survey scores for the 4 knowledge component questions were presented as mean percentages and a pair-wise comparison for matched scores was performed using the Wilcoxon signed rank test as the data were not normally distributed (i.e., skewed). The data were tabulated using Microsoft Excel and analyzed using SPSS, version 18 (SPSS, Chicago, IL). A p value of <0.05 determined significance. The health fair was organized by the Midwestern University College of Pharmacy – Glendale AzPA Student Pharmacist Academy as a community service event. The Midwestern University IRB approved this project. Results Overall, 32 subjects were given pre-tests; 27 subjects completed and returned both the pre- and post-tests. In order to analyze the answers received from the surveys, the 4 objective questions were provided FEATURES
with a score of either 0 or 1, incorrect or correct, respectively, and translated into a percentage score. The subjective questions, 1 and 6, were analyzed independently as qualitative data. There were some instances where not all questions were answered on both the pre- and/or post-survey for a given subject. The analysis of questions 2 through 5 provides for a maximum score of 100% (4/4) on either the preor post-test. The average pre-test score was 68.5% (2.74/4). The average post-test score was 86.1% (3.44/4). The pair-wise comparison for matched scores indicated that the results are statistically significant with a mean percentage difference of 17.6% (p=0.001). A frank majority of the pre-survey sample (17 of 31) answered that they believed their sodium consumption was appropriate. While 44% (11 of 25) of the post- surveys indicated that their sodium consumption was appropriate. Question 6 assessed patient motivation to change their sodium consumption habits. Half of the respondents (6 of 12) indicated they were highly likely to change their lifestyle. Question 5 assessed the participant’s ability to rank food types (fresh, frozen, canned) from least to most sodium content. Twenty-one of 27 pre-surveys were answered correctly. Two of the participants that were initially incorrect improved and answered correctly on the post-survey. The remaining 4 surveys were marked incorrect on both pre- and post-surveys. The seventh question, which appeared only on the post-survey, asked for criticism of the presentation. Few subjects responded, but all respondents indicated the information was useful. Discussion The current literature shows that increased sodium consumption is directly correlated to CVD-related death. The average daily sodium consumption worldwide is 3,950 mg which is believed to contribute to 1.65 million CVD-related deaths annually.8 Our study indicates that student pharmacists can successfully inform the general public of the risks associated with excessive sodium intake via patient counseling. A presentation given during the Glendale Adult Center health fair showed an improvement in sodium related knowledge when comparing knowledge-based pre-and post-test scores. The survey we conducted indicates that the adult patient population is able to learn the recommended daily sodium consumption,
and generally understand the saltiness of different food types, but may be unable to apply this knowledge to their own behavior. Thus, there is potential for student pharmacists to engage in conversation with patients and promote further counseling for behavioral changes. The survey itself is limited in several ways. First, there is no follow-up mechanism embedded in the study. While participants are initially motivated to change their lifestyle, the recommendations provided to reduce sodium consumption require additional time for food preparation and perhaps even additional expense. This reality could have a demotivating effect on the participants. Additionally, 3 student pharmacists gave the presentation over a 3-hour period to the subjects individually and in groups. While this method provides for a more engaging presenter-presentee interaction with opportunity for conversation during the presentation, some of the information may have been communicated differently in light of differing teaching styles and analogies used by each of the 3 student pharmacists. A presenter may become fatigued during several presentations and lose their approachability or not provide the same information that another presenter does. Likewise, in real practice pharmacist consultation will never be exactly the same from pharmacist to pharmacist, from patient to patient. Despite this, an improvement in pre- to post-survey scores was seen in our study. This is a strength for the utility of patient counseling on sodium intake.
patient interaction in every practice setting. This type of project also provides students experience prioritizing counseling topics as well as adjusting counseling style based on specific patient needs (e.g., patient’s time constraints, hard of hearing). In other words, it is instrumental in teaching student pharmacists different ways of communication, a vital skill students will need as practicing pharmacists, and a skill set that is difficult to achieve in the classroom setting. Opportunities to think and write critically are limited during pharmacy education. Mentors add a valuable dimension to the profession by allowing students to think creatively and critically about relevant patient issues and empowering students to communicate with colleagues.
Conclusion A 10-minute presentation was found to improve participants’ knowledge about sodium, indicating that pharmacists can help patients make better food choices regarding sodium intake. Future studies are needed to ensure that the findings hold in larger, more diverse populations and to assess the link between education and lifestyle changes. Figure 1. The questions provided to the participant on both the pre and post-surveys. The pre-survey omitted
Student Perspective questions 6 and 7. Mentors should engage with students in projects of this fashion. The project emphasized the importance of counseling not only on medication, but also healthy lifestyle changes. The exercise allows the mentor and mentees to analyze the results from a standpoint of professional development. With scientific evidence for counseling, it engenders a different attitude towards FEATURES
Fall 2015 • Arizona Journal of Pharmacy • 21
Figure 2. A schematic representation of the poster game. After the participants guessed the sodium content, the card was flipped and the sodium value was revealed along with an alternative to that product that was sensible and specific
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References 1. Centers for Disease Control and Prevention. Sodium: the facts (June 2010). http://www.cdc.gov/salt/pdfs/Sodium_Fact_Sheet.pdf (accessed 2014 Mar 06) 2. Centers for Disease Control and Prevention. Vital signs: prevalence, treatment, and control of hypertension—United States, 1999–2002 and 2005–2008. MMWR Morb Mortal Wkly Rep. 2011;60(4):103–8. 3. Aburto NJ, Ziolkovska A, Hooper L et al. Effect of lower sodium intake on health: systematic review and meta analyses. BMJ. 2013;346:f1326 4. James PA, Oparil S, Carter BL et al. 2014 evidence-based guideline for the management of high blood pressure in adults: report from the panel members appointed to the Eighth Joint National Committee (JNC 8). JAMA. 2014;311(5):507-520. 5. Institute of Medicine of the National Academies. Dietary reference intakes for water, potassium, sodium, chloride and sulfate. Washington, D.C.: The National Academies Press; 2005. 6. Heidenreich PA, Trogdon JG, Khavjou OA et al. Forecasting the future of cardiovascular disease in the United States: a policy statement from the American Heart Association. Circulation. 2011;123(8):933– 44. 7. Palar K, Sturm R. Potential societal savings from reduced sodium consumption in the U.S. adult population. Am J Health Promot. 2009;24(1):49–57. 8. Mozaffarian D, Fahimi S, Singh GM et al. Global sodium consumption and death from cardiovascular causes. N Engl J Med. 2014;371(7):624-34.
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Academy News Community Pharmacy Academy News My name is Valerie Richards, formerly Valerie Bostel, and I am the new community academy chair. Along with my chair-elect, Sophia Galloway, we hope to make this a great year in the academy and in the association as a whole. Sophie and I are currently planning two get-togethers in the year both taking place in Phoenix. We are also hoping to plan one gathering in Tucson. If you have any ideas or suggestions for social events, please do not hesitate to contact us. We want this year to be about you and your community. We know everyone has busy schedules, and we want to work with you. Below, you will find our contacts if you need or want to reach out to us about anything you would like to see in the academy. Additionally, if you are interested in a certain committee, please email the AzPA office or myself and I will get you directed to the correct person. Thank you for being a part of AzPA, and I look forward to hearing and working with all of you! Valerie Richards (Bostel) Community Pharmacy Academy Chair cpa@azpharmacy.org
Geriatric Care Academy News I am honored to serve as your Geriatric Care Academy (GCA) Chair for the 2015-2016 year. We had a successful year last year with member involvement in student health fairs and clinics, continuing education presentations, and conference involvement. A special thanks to our past Chair, Dr. Nicole Early for her dedication and commitment to the GCA. I would also like to welcome our Chair-Elect, Dr. Katherine Murphy. Our goal for the upcoming year is to continue to increase membership involvement. I encourage all pharmacists, students, and technicians to become involved with the GCA. Geriatrics is a topic that can arise in a majority of pharmacy settings. At the 2015 Annual Convention, we had a successful turnout at the GCA meeting and discussed ways to increase membership and involvement. Watch for future emails with dates and events to come!!! Conference calls for the GCA are held on the second Wednesday of every month, from 12:30pm to 1pm. Our first conference call for the 2015-2016 year will be held on August 12th. Follow up emails will be sent with additional information. Do not hesitate to contact me if you have any questions or concerns and/or if you are interested in becoming more involved in the GCA. Jessica DiLeo, PharmD Geriatric Care Academy Chair gca@azpharmacy.org
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Learn more at azpharmacy.org/shop4APF Fall 2015 • Arizona Journal of Pharmacy • 23
Health-System Academy News The Health-System Academy members had good discussions at the Annual Convention. Thank you to all those who attended. We are looking for HSA members interested in legislative advocacy to participate in Pharmacy Day at the Capitol – AzPA’s day to meet and lobby with AZ legislators. The HSA group is particularly interested in educating legislators on the value of health-systems pharmacist. AzPA can help provide talking points. Please let me know if you are interested. Looking forward, we are excited to plan some outreach events. If anyone is interested in participating to help educate community members, please let me know. I hope you will join us for this great action-packed year. The Health-System Academy of the Arizona Pharmacy Association is the Arizona affiliate of the American Society of Health-System Pharmacists (ASHP).
Lisa Tonrey, RPh, FAPhA Health-System Academy Chair hsa@azpharmacy.org
Arizona
Managed Care Academy News It is a great honor to represent the Managed Care Academy and I look forward to having a fun and eventful year for our academy. I and others would like to thank Paul Lynne for serving as our past chair and welcome Darren Clonts as our Managed Care Chair-elect. MCA had a very fun and interactive academy meeting during the Annual Conference and we came up with many fun meet and greet activities which we hope to get started as the year goes on. We are also looking to have future speakers for our upcoming conferences as well. I am looking forward to an exciting year for our Managed Care Academy and hope you will join us every 3rd Thursday of the month at 7am for our monthly phone conferences. Don’t forget, coming this September will be our Fall Conference in Phoenix. So hope to see you there. If you have any questions or interests in Managed Care, please feel free to contact me at any Susan Halterman, RPh time and I will get back to you. Managed Care Academy Chair mca@azpharmacy.org
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Visit azpharmacy.org Login on the right hand side of website Select Manage Profile (on right) Select Edit Bio Scroll to ‘AzPA Academy Affiliation’ field Select the appropriate academy You may also choose a secondary academy
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Academy Meeting Calendar • ACCP Officer Meeting: 2nd Tues of the month at
12pm • Community Pharmacy Academy: 3rd Thurs of the month at 7am • Geriatric Care Academy: 2nd Wed of the month at 12:30pm • HSA Executive Committee: 2nd Thur of the month at 1pm • Managed Care Academy: 3rd Thur of the month at 7am • Student Pharmacy Academy: Contact Academy Chairs • Technician Academy: 2nd Wed at 7pm
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Student Pharmacist Academy News The Student Pharmacist Academy had an amazing summer which included the AzPA Annual Convention and our always popular Student Track. This year we had quite a few great sessions, such as our poster presentations, clinical pearls, mock interviews, and Casino Night. We would like to thank all of the students who presented and volunteered throughout the event, as well as our pharmacist leaders, Gina Gries, Valerie Bostel, and Jessica DiLeo. MWU would like to welcome its new Class of 2018 students to our school! During their first quarter here, our SPA chapter has hosted an information session detailing all of the amazing benefits that come with joining our organization and a membership drive where we welcomed many new members. This Fall we have our Annual Safe Halloween event coming up where we use the Katy’s Kids program to educate children in the area about the difference between medication and candy. Finally, as your new chairs for SPA, we (Paris and Mika) would like to take the time to say thank you to our previous chairs, Nicole Evans and Pearce Engelder. Their leadership has helped us prepare for our new roles in this organization. We are excited to see what this new school year brings and wish all of our members the best of luck in their classes! Paris Cook, SPA Co-Chair, Midwestern University of College of Pharmacy Glendale pcook91@midwestern.edu Mika Jankowski, SPA Co-Chair University of Arizona College of Pharmacy engelder@pharmacy.arizona.edu
Technician Academy News Thank you to all who attended the Annual Convention! We had a great Academy meeting Friday evening. In particular a big thank you to Reg Roy for the work he has put into the Academy the past year and foundation laid for the future. Congratulations to Jennifer Lechner who was awarded the AzPA’s Technician of the Year Award, and JR Gill who was awarded the AzPA Pharmacy Appreciation Award. We also extend a warm welcome to Luz Rashan who is our new ChairElect. She has already been actively involved in the academy, and we are excited to continue working together moving forward. To help our academy prioritize the many projects and initiatives we undertake this year, we are focusing on three strategic pillars that stem from AzPA’s overall strategic plan: Education, Outreach, and Advancement. For Education, we are actively working on providing technician-developed CE programs and engaging in the national discussion surrounding education of technicians generally. For Outreach, we have connected with several Technician Training programs throughout the state and have officially launched the Technician Mentor Connection Program where tech students are paired with working technicians to help give them a leg up as they launch their careers. We have also adopted Diabetes as our Charity of the Year, so be on the lookout for events in the community where we will have a presence. For Advancement, we are actively participating in discussion of technician roles now and in the future and building awareness regarding these issues with the ultimate goal of ensuring that the work technicians do improves patient safety and outcomes. These are just a sampling of the projects we are currently engaged in. Reach out to me personally or join us for our monthly phone call (make sure your email is updated on azpharmacy.org to get invitations to the meetings) to talk about how you can get involved. Many hands make light work, so please help us get our profession moving in the great state of Arizona! Kalani Anderson, C.Ph.T. Technician Academy Chair tech@azpharmacy.org
ACADEMY NEWS
Fall 2015 • Arizona Journal of Pharmacy • 25
CONTINUING EDUCATION New Oral Anticoagulants: A General Overview of Dabigatran, Rivaroxaban and Apixaban
by Kristin Sechena, Pharm.D, Adam Womack Pharm.D, Laura Tsu, Pharm.D, Midwestern University College of Pharmacy-Glendale Goal: This home-study CPE activity has been developed to: 1. Provide a general overview of all the available oral anticoagulant drugs, with a focus on the newest agents. 2. Increase awareness of the intricacies involved in prescribing of the new oral anticoagulants. 3. Improve patient outcomes by ensuring the proper agent is chosen for each individual. At the conclusion of this CPE activity, successful participants should be able to: Objectives for Pharmacists: 1. Provide background information on each of the new oral anticoagulants, including the studies which earned them approval from the FDA. 2. List monitoring parameters of the new oral anticoagulants and which techniques may become more prevalent in the future. 3. Discuss the techniques for reversal of the new oral anticoagulants and provide a glimpse at promising antidotes which are currently under development. 4. Develop a process of switching to and from warfarin to the new oral anticoagulants and how to manage surgical patients currently using the new oral anticoagulants. Objectives for Pharmacy Technicians: 1. Provide background information on each of the new oral anticoagulants, including the studies which earned them approval from the FDA. 2. List monitoring parameters of the new oral anticoagulants and which techniques may become more prevalent in the future. 3. Discuss the techniques for reversal of the new oral anticoagulants and provide a glimpse at promising antidotes which are currently under development.
Introduction In 1954 the medical community was excited by the introduction of the first oral anticoagulant drug – warfarin. As a vitamin K antagonist, warfarin is able to block the production of the vitamin K dependent clotting factors II, VII, IX and X. Prior to this point there were no oral agents which could be used for the treatment or prevention of clotting in predisposing disease states. Fast forward to 2010 and the release of dabigatran, a direct thrombin inhibitor, and finally there was an alternative to warfa-
rin. This was shortly followed by the approval of two factor Xa inhibitors; rivaroxaban in 2011 and apixaban in 2012. Each class of new agents offers its own set of advantages and disadvantages, but the true limitation for them all is a lack of longterm data. The purpose of this article is to present current information on the Food and Drug Administration (FDA) approved oral anticoagulant drugs and how best to manage them. Warfarin (CoumadinŽ) Many clinicians today are familiar with the administration and monitoring of warfarin therapy. In fact, there are practitioners who spend their whole day managing warfarin therapy in the outpatient setting. For this reason, the following section will only be a quick review of warfarin therapy, whereas the latter sections of this article will focus more extensively on the newer oral anticoagulants. Warfarin initiated in the outpatient setting can be dosed as high as 10 mg daily. For more fragile patients, including those with low body weight or organ dysfunction, it is best to be conservative with initial dosing and keep it between 2-5 mg. Since warfarin inhibits only the production of the vitamin K dependent clotting factors, and does not affect factors already in circulation, circulating factors are able to maintain clotting in the body for approximately 5 days before being eliminated. For this reason the initiation of warfarin in patients at a high risk of clotting requires an overlap of parenteral anticoagulation for 5 days. The Chest 2012 Guidelines suggest the use of parenteral anticoagulation for the first 5 days of warfarin therapy and until the patient’s International Normalized Ratio (INR) remains greater than or equal to 2 for at least 24 hours. The target INR for most disease states is 2-3, with the only exception being mechanical mitral valves, which require an INR of 2.5-3.5.2 This is illustrated in Table 1. One of the major advantages of warfarin is that it can be used in both renal and hepatic
Oral Anticoagulants dysfunction. This is because dosing is based off the patient’s INR which is measured directly from their blood sample. The patient’s INR is affected by any organ dysfunction prior to being measured, so any adjustments automatically factor in organ dysfunction. Warfarin also has the advantage of only being dosed once daily and being a very affordable medication. With INR monitoring equipment being so readily available, it is also very simple for clinicians to determine the degree to which a patient is anticoagulated. This allows quick assessment of the patient in situations where bleeding is a concern, such as emergency surgery. On the down side, warfarin also has numerous food and drug interactions. Since it is metabolized by the hepatic enzymes CYP2C9 (primary isoenzyme), CYP2C19, CYP2C8, CYP2C18, CYP1A2 and CYP3A4, any other substance which is also metabolized by these enzymes or affects their rate of metabolism has the possibility of impacting warfarin serum concentrations.2 Another disadvantage of warfarin is the regular monitoring required to ensure that INRs are therapeutic. This can be a significant inconvenience to the life of a busy patient. Since warfarin is a vitamin K antagonist, it makes sense that vitamin K is used to reverse its effects. The 2012 Chest guidelines recommend against the regular use of vitamin K in warfarin patients because vitamin K is a fat soluble vitamin which accumulates in fatty tissues.1 Accumulated vitamin K will then remain within the patient’s body, potentially making them refractory to the re-initiation of warfarin therapy. In patients with INRs between 4.5 and 10 who are not actively bleeding, it is recommended to either hold or reduce the next warfarin dose. In patients with INRs greater than 10, oral vitamin K is recommended. In patients with active bleeding, no matter what their INR, it is recommended that they receive intravenous (IV) vitamin K. It is important to note while IV vitamin K does have a faster onset of action, it also carries the risk of anaphylactoid reactions and is not preferred over oral vitamin K.1 When there is an urgent need for reversal of warfarin in an actively bleeding patient it may be necessary to use a faster acting product to aid in clotting. The different options include fresh frozen plasma (FFP), prothrombin complex concentrates (either PCC3 or PCC4), recombinant activated factor 7 (rFVIIa) and activated prothrombin complex concentrates (aPCC).3 The common doses of these agents are included in table 2. It is important to remember CONTINUING EDUCATION
that the administration of these agents may increase the likelihood of clotting. This is especially true of the activated products (aPCC and rFVIIa) which are known to be prothrombotic. Whenever a patient requires surgery, it is important to assess whether or not their risk of clotting outweighs their risk of bleeding. Patients at a high risk of clotting are those whom have any one of the following characteristics: mitral valve replacement, mechanical aortic valves, recent stroke or transient ischemic attack (TIA), atrial fibrillation with a CHADS2 score greater than or equal to 5, rheumatic valvular heart disease, or recent venous thromboembolism. Five days prior to the surgical procedure the patient should stop taking warfarin. The goal INR prior to the procedure is less than 1.5. Three days prior to the procedure the patient should be started on parenteral anticoagulation with either low molecular weight heparin (LMWH), unfractionated heparin (UFH) or fondaparinux. If therapeutic dose (1 mg/kg) subcutaneous LMWH is used, it should be discontinue 24 hours prior to the procedure. If a once daily regimen of LMWH is used, then half of the total daily dose should be given the morning before the procedure, but if a twice daily regimen is used only the morning dose the day prior to the procedure should be given. If UFH is used rather than LMWH, it should be initiated three days prior to the procedure and discontinued 4-6 hours prior to the procedure. Once the procedure has been completed and there is adequate hemostasis, LMWH/UFH can be restarted 24 hours post-operation in low bleeding risk patients and 4872 hours post-operation in high bleeding risk patients. Warfarin should be restarted 12-24 hours after the procedure and when there is adequate hemostasis. Warfarin and the parenteral anticoagulant should be continued for 5 days and until the patient’s INR is greater than or equal to 2 for at least 24 hours.4 Dabigatran (Pradaxa®) Unlike the other new oral anticoagulants, dabigatran is a prodrug that works as a direct thrombin inhibitor. Dabigatran was the first of the new oral anticoagulants to become available. It initially gained approval for the indication of stroke and systemic embolism prevention in those with non-valvular atrial fibrillation in October of 2010.5 Most recently dabigatran was also granted approval for the indication of venous thromboembolism (VTE) treatment and Fall 2015 • Arizona Journal of Pharmacy • 27
Oral Anticoagulants recurrent risk reduction.6 For this indication, the recommended dose of dabigatran is 150 mg twice daily in patients with a creatinine clearance (CrCl) >30 mL/ min, which should only be initiated following 5 to 10 days of parenteral anticoagulation. For use in atrial fibrillation, 150 mg twice daily is also recommended, however there is no requirement for parenteral anticoagulation prior to initiating dabigatran in this instance. A dosage reduction to 75 mg twice daily is recommended for use in atrial fibrillation with a CrCl of 15-30 mL/min. However, this dose has not been studied through clinical trials, but rather represents a recommendation based on pharmacokinetic extrapolation. Additionally, the use of dabigatran in patients with a CrCl <15 mL/min should be avoided. Because dabigatran is subject to drug interactions with p-glycoprotein inhibitors and inducers, in those with a CrCl 30-50 mL/min who are using concomitant p-glycoprotein inhibitors such as dronedarone or oral ketoconazole, a reduction in dabigatran dosing to 75 mg twice daily is recommended. Anyone with a CrCl <30 mL/min who is taking a concomitant p-glycoprotein inhibitor should avoid the use of dabigatran altogether. Regarding the indication of VTE treatment and recurrent risk reduction, dabigatran use in anyone with a CrCl <30 mL/min should be avoided as clinical trials have excluded this population.7 Approval for stroke and systemic embolism prevention in those with non-valvular atrial fibrillation was granted based on the results of the phase III noninferiority study, The Randomized Evaluation of Long-Term Anticoagulation Therapy (RE-LY) trial. This trial compared the use of 2 different doses of dabigatran versus warfarin in patients with atrial fibrillation having at least 1 risk factor for stroke. For the primary efficacy endpoint of stroke or systemic embolism, dabigatran dosed at 110 mg twice daily, was noninferior to warfarin (1.53% vs. 1.69% of patients annually, hazard ratio 0.91 (0.74-1.11); P<0.001 for noninferiority). Dabigatran dosed at 150 mg twice daily was superior to warfarin (1.11% vs. 1.69% of patients annually, hazard ratio 0.66 (0.53-0.82); P<0.001 for superiority). The rate of major bleeding was significantly lower with dabigatran 110 mg twice daily compared to warfarin, whereas major bleeding rates were similar between dabigatran 150 mg twice daily and warfarin. Of note, for dabigatran 150 mg twice daily, the rate of gastrointestinal (GI) bleeding was higher in comparison to warfarin (1.51% vs. 1.02% CONTINUING EDUCATION
of patients annually, relative risk 1.50 (1.19-1.89); P<0.001), and the incidence of intracranial bleeding was lower (0.30% vs. 0.75% of patients annually, relative risk 0.40 (0.27-0.60); P<0.001).8 Several trials were instrumental in supporting the approval of dabigatran for use in the treatment and recurrent risk reduction of VTE. In RE-COVER, a randomized, double-blind, noninferiority trial, following an initial median treatment period of 9 days with parenteral anticoagulation, patients with acute VTE received either dabigatran 150 mg twice daily or dose-adjusted warfarin for a period of 6 months. Dabigatran was found to be noninferior to warfarin for the primary efficacy endpoint of recurrent VTE and related deaths (2.4% vs. 2.1% of patients, CI -0.8-1.5; P<0.001 for noninferiority). The risk of major bleeding was similar between groups.9 In a repeat trial, RE-COVER II, the results of the RE-COVER trial were confirmed and dabigatran was again found noninferior to warfarin for the primary efficacy endpoint of recurrent VTE and related deaths (2.3% vs. 2.2% of patients, hazard ratio 1.08 (0.64-1.8); P<0.001 for noninferiority). Major bleeding episodes between groups were also found to be similar (1.2% vs. 1.7% of patients, hazard ratio 0.69 (0.36-1.32); P<0.001).10 Extended treatment with dabigatran for 6-36 months in patients with acute VTE who had already received a minimum of 3 months of anticoagulation was investigated through the RE-MEDY and RESONATE trials. RE-MEDY served as the active-control study by comparing dabigatran 150 mg twice daily to dose adjusted warfarin, whereas RE-SONATE was designed as its placebo-control counterpart, comparing dabigatran 150 mg twice daily to placebo. RE-MEDY found dabigatran to be noninferior to warfarin in the prevention of recurrent VTE or related deaths (1.8% vs. 1.3% of patients, hazard ratio 1.44 (0.78-2.64); P=0.01 for noninferiority). No significant difference in the rate of major bleeding was found between groups (0.9% vs. 1.8% of patients, hazard ratio 0.52 (0.27-1.02); P=0.06). In RE-SONATE, dabigatran was found to be superior in significantly decreasing the incidence of recurrent VTE and related deaths compared to placebo (0.4% vs. 5.6% of patients, hazard ratio 0.08 (0.02-0.25); P<0.001). No significant difference between groups in the rate of major bleeding was found.11 Although several trials have shown no significant difference in major bleeding risk between dabigatran
and warfarin, numerous cases of hemorrhage have been reported during post-marketing surveillance, particularly in those over 80 years old.12 These findings are further supported by the trend demonstrated in the RE-LY trial of increased bleeding risk in those over 75 years old.13 Therefore, dabigatran should be used with caution in the geriatric population or other treatment options should be considered. Advantages of dabigatran over warfarin include a lower potential for drug interactions, fixed dosing, rapid onset of anticoagulation (1-3 hours), lack of need for special dietary considerations and predictable pharmacokinetics and pharmacodynamics, which negate the need for routine monitoring.14 However, dabigatran is associated with several disadvantages as well, one of which is the potential for high expense to the patient due to a lack of or insufficient insurance coverage. Prior authorization following treatment failure or intolerance to warfarin may also be needed to ascertain insurance coverage.15 Potential side effects may also present a challenge to patients, especially that of dyspepsia, which is both a common and troubling effect associated with the use of dabigatran.15 Additionally, there is limited data pertaining to its use in various clinical situations including use with neuraxial anesthesia and catheter directed ablation of atrial fibrillation. Yet another consideration for healthcare providers to recognize is that dabigatran capsules cannot be opened or crushed, as doing so will increase the exposure of dabigatran by 75% in comparison to the intact capsule.15 This matter is both pertinent to outpatient administration as well as inpatient administration, as alternative anticoagulants should be considered for patients requiring feeding tubes.15 Aside from warning patients not to crush dabigatran capsules, additional counseling should include the need for special storage considerations. Because dabigatran capsules are sensitive to moisture, they should be stored in their original container, which contains a desiccant to prevent medication degradation.15 Once opened, capsules should be used within 4 months.16 Other counseling points should include the importance of reporting any signs or symptoms of bleeding, the need to consult a healthcare provider before starting any new medications (due to the potential for drug interactions or agents which may further increase bleeding risk) and a warning to CONTINUING EDUCATION
Oral Anticoagulants avoid premature discontinuation of treatment, which reflects dabigatran’s black box warning of increased risk of thrombotic events upon discontinuation. This point is especially important in patients with atrial fibrillation taking this medication for stroke and systemic embolism prevention. Dabigatran also has a second black box warning for risk of spinal or epidural hematoma in those undergoing spinal puncture.16 Table 1 Warfarin Target INR for Various Disease States.2
Laboratory monitoring of dabigatran There are no well-established laboratory monitoring techniques for the new oral anticoagulants, which is one of the reasons many clinicians are wary of their use. Fortunately, there are techniques which will hopefully be available in the near future to accurately assess the amount of active dabigatran in a patient’s body. The most useful tests are those sensitive to dabigatran at all concentrations. These include chromogenic antifactor IIa and ecarin clotting time (ECT). Chromogenic antifactor IIa uses the same equipment as the chromogenic antifactor Xa which is used to monitor serum levels of LMWH, UFH and fondaparinux. Unfortunately, a specific assay for dabigatran is required to calibrate the machine to detect its concentration in a patient’s plasma sample. These assays are not commercially available, making them very difficult to obtain and the test itself much less likely to be used. This may be more widely available in the future. The second test which is useful for detecting dabigatran levels is the ECT. This test is most commonly used in research hospitals and is not widely available. As it increases in popularity and affordability, it may be seen more often. Another option which is not as sensitive or reliable as the others is the activated partial thromboplastin time (aPTT). It can normally detect dabigatran at its normal therapeutic concentraFall 2015 • Arizona Journal of Pharmacy • 29
Oral Anticoagulants tions, but is not as reliable as either chromogenic antifactor IIa or ECT.3 When it comes to reversal of dabigatran, there is no currently approved antidote, so the use of clotting factors is typically necessary to reverse the drug’s anticoagulant affect. Eerenberg and colleagues studied the currently available clotting factors for reversal of anticoagulation in healthy human patients. He found that PCC4 was not effective for reversing the effects of dabigatran.17 Fortunately, there are two case studies which indicate that the activated clotting products are useful in the reversal of significant bleeding associated with dabigatran. Dager and colleagues successfully used aPCC to stop significant bleeding in a patient undergoing atrial fibrillation ablation.18 Warkentin and colleagues used rFVIIa to stop significant bleeding in a 79 year old undergoing aortic valve replacement and coronary artery bypass graft.19 The suggested dosing for the different clotting factors can be found in table 3. There is also a new agent currently in animal testing called aDabi-Fab which is a recombinant thrombin decoy. Dabigatran has a much higher affinity for this agent and will bind to it preferentially over endogenous human thrombin, essentially removing the anticoagulant effects of dabigatran from circulation.20 aDabi-Fab has been successful in animals and may be a product approved by the FDA sometime in the future. The process for converting warfarin to dabigatran is very simple and involves discontinuing warfarin, waiting until the patient’s INR is less than 2, then initiating dabigatran. When doing the opposite and converting dabigatran to warfarin, things get a little more complicated. There are two techniques which can be used. The first technique is done using only oral agents and overlapping warfarin with dabigatran for a certain number of days. The number of days of overlap is determined by the patient’s renal function and is described in table 4. The goal of this technique is to keep dabigatran in the patient’s system until warfarin becomes therapeutic. The second technique involves stopping dabigatran and starting a parenteral anticoagulant 12 hours after the last dabigatran dose in patients with CrCl >30 mL/min. If the patient has a CrCl <30 mL/min, the parenteral anticoagulant should be initiated 24 hours after the last dabigatran dose. After 2 days without dabigatran, warfarin should be initiated CONTINUING EDUCATION
and continued with parenteral anticoagulation for 5 days and until the INR is greater than or equal to 2 for at least 24 hours.6 Prior to a surgical procedure it is necessary to bridge dabigatran, especially in atrial fibrillation patients who would be at an increased risk of stroke after discontinuation of the drug. Determination of the amount of time prior to the procedure that dabigatran must be discontinued is based on the patient’s renal function and the bleeding risk associated with the procedure. The details are outlined in table 5. In order to bridge dabigatran, the parenteral anticoagulant should be initiated 12 hours after dabigatran discontinuation in patients with a CrCl greater than 30 and after 24 hours in patients with a CrCl less than 30. If therapeutic dose (1 mg/kg) subcutaneous LMWH is used, it should be discontinued 24 hours prior to the procedure. If a once daily regimen of LMWH is used, then half of the total daily dose should be given the morning before the procedure, but if a twice daily regimen is used only the morning dose the day prior to the procedure should be given. If UFH is used rather than LMWH, it should be initiated three days prior to the procedure and discontinued 4-6 hours prior to the procedure. Once the procedure has been completed and there is adequate hemostasis, dabigatran should be started 24 hours after the procedure.6 Rivaroxaban (Xarelto®) Rivaroxaban is the first oral factor Xa inhibitor which received approval for use in the United States.21 It is approved for stroke and systemic embolism prevention in non-valvular atrial fibrillation, deep vein thrombosis (DVT) prevention in total hip or knee replacement and for the treatment and recurrent risk reduction of DVT and pulmonary embolism (PE). Dosing for use in atrial fibrillation is 20 mg once daily with the evening meal, with recommendations for dose reduction to 15 mg daily in those with a CrCl 15-50 mL/min, and avoidance of use in patients with a CrCl <15 mL/min. For all other indications, rivaroxaban use in patients with a CrCl <30 mL/min should be avoided. Dosing for either total hip or knee replacement is 10 mg once daily, whereas DVT/PE treatment requires 15 mg twice daily for the first 3 weeks of treatment followed by 20 mg once daily with food.22 ROCKET-AF is the landmark trial which allowed rivaroxaban to obtain approval for stroke and systemic embolism prevention in atrial fibrillation. This ran-
domized, event-driven, double-blind trial compared rivaroxaban to dose adjusted warfarin in patients with non-valvular atrial fibrillation having a CHADS2 score greater than or equal to 2. Rivaroxaban was dosed at 20 mg once daily, or was modified to 15 mg once daily in those with a CrCl 30-49 mL/min. For efficacy in preventing stroke and systemic embolism, rivaroxaban was found to be noninferior to warfarin (1.7% vs. 2.2% of patients per year, hazard ratio 0.79 (0.66-0.96); P<0.001). The primary safety endpoint of composite major and clinically relevant non-major bleeding was not significantly different between rivaroxaban and warfarin groups (14.9% and 14.5% of patients per year, hazard ratio 1.03 (0.96-1.11); P=0.44). Similar to the increased GI bleeding found in the RE-LY trial with dabigatran, rivaroxaban was also found in ROCKET-AF to cause significantly more GI bleeds in comparison to warfarin (3.2% vs. 2.2% of patients per year; P<0.001).23 The RECORD trials were instrumental in allowing rivaroxaban to gain approval for DVT prophylaxis in total hip and knee replacement. In RECORD-1, patients undergoing total hip replacement received either rivaroxaban 10 mg by mouth (PO) once daily or enoxaparin 40 mg subcutaneously (SQ) once daily for thromboprophylaxis. Results revealed rivaroxaban to be superior to enoxaparin for the composite endpoint of DVT, non-fatal PE and death when compared to enoxaparin (1.1% vs. 3.7% of patients; P<0.001). Major bleeding was not significantly different between groups (0.3% vs. 0.1% of patients; P=0.18).24 RECORD-3 also compared rivaroxaban 10 mg PO once daily to enoxaparin 40 mg SQ once daily for thromboprophylaxis, but in those undergoing elective total knee replacement. As in RECORD-1 for total hip replacement, rivaroxaban was once again found to be superior to enoxaparin for the composite endpoint of DVT, non-fatal PE, and death (9.6% vs. 18.9% of patients; P<0.001), with no significant difference in the risk of major bleeding between groups (0.6% vs. 0.5% of patients; P=0.77).25 Another important set of trials are the EINSTEIN trials, which provided evidence for rivaroxaban use in the setting of acute DVT and PE. In the EINSTEIN-DVT trial, rivaroxaban 15 mg PO twice daily for 3 weeks, followed by 20 mg once daily was compared to the standard therapy of enoxaparin 1 mg/kg SQ twice daily bridged to dose-adjusted warfarin for 3, 6, or 12 months in patients with acute DVT. For the preCONTINUING EDUCATION
Oral Anticoagulants vention of recurrent VTE, rivaroxaban was found to be noninferior to standard therapy (2.1% vs. 3.0% of patients, hazard ratio 0.68 (0.44-1.04); P<0.001). No significant difference was identified between groups for the composite endpoint of major or clinically significant non-major bleeding (1.3% vs. 7.1% of patients; P<0.001).26 EINSTEIN-PE also compared rivaroxaban to standard therapy as in EINSTEIN-DVT, but in patients with acute PE. Rivaroxaban was found to be noninferior to standard therapy (2.1% vs. 1.8% of patients, hazard ratio 1.12 (0.75-1.68); P=0.003) and no significant difference was found between groups for composite major and clinically relevant non-major bleeding (10.3% vs. 11.4% of patients, hazard ratio 0.9 (0.761.07); P=0.23).27 The aforementioned trials demonstrate a similar bleeding risk associated with rivaroxaban when compared to either enoxaparin or warfarin. However, it is important to be aware of the increased risk of GI bleeding with rivaroxaban identified by the ROCKET-AF trial.23 In addition to bleeding risk, when selecting the best anticoagulant for a patient, it is also necessary to consider the concomitant medications any given patient is taking, as rivaroxaban may interact with both CYP3A4 as well as p-glycoprotein inhibitors and inducers. Patient groups more likely to be prescribed these interacting agents include those with a seizure disorder, human immunodeficiency virus positive patients and those receiving antifungal treatment.21 Despite the presence of CYP3A4 and p-glycoprotein drug interactions, rivaroxaban still has fewer drug interactions in comparison to warfarin. Other advantages to using rivaroxaban include a rapid onset of anticoagulation (within 2-4 hours), the potential for once daily, fixed dosing and a lack of need for routine monitoring.14,21 There are drawbacks associated with rivaroxaban use as well, such as a potential lack of insurance coverage or high co-payments for the patient. Data is also limited, or lacking, regarding rivaroxaban use in neuraxial anesthesia and catheter directed ablation of atrial fibrillation.21 Additionally, rivaroxaban has 2 black box warnings, which mirror those of dabigatran. The black box warnings are for increased risk of thrombotic events upon premature discontinuation of rivaroxaban, and increased risk of spinal or epidural hematomas with spinal puncture. Therefore, Fall 2015 • Arizona Journal of Pharmacy • 31
Oral Anticoagulants because of the risk of thrombosis with early discontinuation, patients should be counseled to consult a healthcare provider prior to discontinuing this medication, so that an alternative anticoagulant may be started as needed.22 An additional counseling point for rivaroxaban is the need to take any dose ≥15 mg daily with food in order to increase the drug’s bioavailability. Although this medication is recommended to be taken with the evening meal, should this recommendation compromise compliance, dosing with an alternative meal may be considered. For doses of 10 mg daily, bioavailability is between 80% and 100% in either the fasted or fed state. Therefore, this dose does not necessitate administration with food. To facilitate administration, rivaroxaban may be crushed and mixed with either water or applesauce. Use with nasogastric tubes is also acceptable, although rivaroxaban should not be used with jejunostomy tubes, as decreased absorption of rivaroxaban may occur.21 Because of the potential for drug interactions, patients should be instructed to consult a healthcare provider before starting any new medications. Counseling should also cover the need to report any signs or symptoms of bleeding such as the presence of blood in the urine or stool, easy bruising or prolonged or frequent bleeding from minor wounds.21 Table 2 Warfarin Reversal with Clotting Factors.3
Table 3 Dabigatran Reversal with Clotting Factors.3
CONTINUING EDUCATION
Laboratory Monitoring Rivaroxaban and Apixaban The laboratory monitoring for both rivaroxaban and apixaban is quite similar. Just as is the case with dabigatran, there is no well-established standard for the monitoring of factor Xa inhibitors. Some tests which are not widely available, but may be seen more in the future are chromogenic antifactor Xa and thromboelastography. These are both sensitive to the drug at all concentrations. Chromogenic antifactor Xa monitoring requires a specific assay for each drug in order to calibrate the machine. These calibration assays are available for rivaroxaban and apixaban, so once they become more affordable, they may become the monitoring technique of choice.28 The second test is thromboelastography. This is currently used in intensive care units for monitoring of patient coagulation during surgery, however it does not yet have standardized measurements to determine how much or little the factor Xa inhibitors are anticoagulating a patient. There is currently research being done to develop these standards. If this happens, thromboelastography may become more popular in monitoring the new oral anticoagulant drugs.29 Eerenberg and colleagues studied the different clotting factor products available for the reversal of rivaroxaban and found that PCC4 reversed rivaroxaban’s anticoagulant effect within 15 minutes.17 This study was done in healthy humans and is some of the best data to date on rivaroxaban reversal. Since apixaban has a similar mechanism of action to rivaroxaban, it can be assumed that these results would also apply to apixaban. Table 6 lists common dosing for the different clotting factors used in factor Xa inhibitor reversal. A new agent currently in phase 3 trials is called Andexanet Alfa and is a recombinant factor Xa decoy. Both rivaroxaban and apixaban have a much higher affinity for binding Andexanet Alfa than endogenous human factor Xa. Andexanet Alfa also does not have any procoagulant effects, so once it binds the factor Xa inhibitor in the patient’s body, the patient is able to return to normal clotting. Phase 2 interim results have been reported and show that two minutes after a bolus of Andexanet Alfa there was nearly complete reversal of the anticoagulant effect of both rivaroxaban and apixaban. This new agent looks very promising and may receive FDA approval in the near future.30 Switching from warfarin to rivaroxaban is, again, a simple matter. All that needs to be done after stop-
Oral Anticoagulants ping warfarin is to ensure the patient’s INR is less than 3 and start rivaroxaban. Switching from warfarin to rivaroxaban can be done using only oral agents, or using a parenteral anticoagulant for the overlap with warfarin. This process requires consideration of the patient’s renal function and is detailed in table 7.22 Bridging with rivaroxaban is somewhat complicated and can use either rivaroxaban alone or with a parenteral anticoagulant. When rivaroxaban alone is used, the amount of time prior to surgical procedure that it needs to be discontinued is determined by the patient’s renal function, hepatic function and the bleeding risk associated with the procedure. This process is detailed in table 8. If the physician prefers, rivaroxaban can be discontinued at a date earlier than the procedure (ensure this date is several days prior to the recommended amount of time discussed in table 8) and a parenteral anticoagulant can be started a certain amount of time after the rivaroxaban is discontinued. The amount of time after the last rivaroxaban dose is based on the patient’s renal function. With CrCl >50 mL/min, the parenteral anticoagulant should be started 12-24 hours after the last rivaroxaban dose. With CrCl <50 mL/min, the parenteral anticoagulant should be started 24 hours after the last rivaroxaban dose. The remainder of the bridging process is done identically to warfarin bridging, except that once the surgery is complete and there is adequate hemostasis, the patient should be restarted on only rivaroxaban 24 hours after the procedure.22 Apixaban (Eliquis®) The most recently approved new oral anticoagulant is apixaban, which similar to rivaroxaban, is a factor Xa inhibitor. Apixaban was originally approved for stroke and systemic embolism prevention in atrial fibrillation. Recommended dosing for this indication is 5 mg twice daily. However, a dose reduction to 2.5 mg twice daily is recommended for patients who have at least 2 of the following: ≥80 years old, ≤60 kg, or a serum creatinine (SCr) ≥1.5 mg/dL. Dosing guidelines are based on the dosing parameters used in the ARISTOTLE trial. In March of 2014, apixaban was additionally approved for DVT prevention in total hip or knee replacement. Dosing based on this indication is 2.5 mg twice daily.31 Approval for use in atrial fibrillation was granted largely based on the results of the ARISTOTLE trial. CONTINUING EDUCATION
In this trial, apixaban was compared to dose-adjusted warfarin in patients with atrial fibrillation having at least 1 risk factor for stroke. The results showed apixaban to be superior to warfarin for the endpoint of stroke and systemic embolism prevention (1.27% vs. 1.6% of patients per year, hazard ratio 0.79 (0.660.95); P<0.001 for noninferiority, P=0.01 for superiority). With regard to the primary safety endpoint of major bleeding, apixaban was once again found to be superior to warfarin (2.13% vs 3.09% of patients per year, hazard ratio 0.69 (0.6-0.8); P<0.001). Unlike rivaroxaban and dabigatran use in atrial fibrillation, apixaban did not show any significant increase in the risk of GI bleeding when compared to warfarin (0.76% vs. 0.86% of patients per year; P=0.37).32 The ADVANCE trials facilitated the ability of apixaban to gain approval for use following total hip and knee replacement. ADVANCE-2 compared apixaban 2.5 mg PO twice daily to enoxaparin 40 mg SQ daily in patients following total knee replacement after ADVANCE-1 failed to show apixaban to be noninferior to enoxaparin 30 mg SQ twice daily following total knee replacement.33,34 ADVANCE-2 showed apixaban to be superior to enoxaparin in preventing composite total VTE and all-cause mortality (15% vs. 24% of patients; P<0.0001). No significant difference was found between groups for the composite of major and clinically relevant non-major bleeding (4% vs. 5% of patients; P=0.09).33 ADVANCE-3 followed the same study design as in ADVANCE-2, but compared apixaban versus enoxaparin in patients who underwent total hip replacement. For the primary composite efficacy outcome of prevention of total VTE and allcause mortality, apixaban demonstrated superiority to enoxaparin.35 Among the discussed trials, apixaban was found to reduce bleeding risk, or show similar bleeding risk, when compared to either enoxaparin or warfarin. It is also worth reiterating that through the ARISTOTLE trial, apixaban was shown to be the only one of the new oral anticoagulants which did not demonstrate a significantly increased incidence of GI bleeding when compared to warfarin in patients with non-valvular atrial fibrillation.32 Additional advantages to using apixaban include twice daily fixed dosing, a rapid onset of action (within 1-3 hours), the ability to crush the medication and administer it via nasogastric tubes, a lack of need for special dietary considerations and the absence of reFall 2015 • Arizona Journal of Pharmacy • 33
Oral Anticoagulants quired drug level monitoring. As with the other new oral anticoagulants, apixaban interacts with fewer medications than warfarin. However, the potential for drug interactions still exists, particularly with CYP3A4 and p-glycoprotein inhibitors and inducers.15,31 One barrier to the use of apixaban includes the potential for complicated dosing when used in certain patient populations. For example, age, weight, and serum creatinine must all be accounted for when dosing patients with atrial fibrillation.31 Additionally, apixaban co-payments may be unacceptably high to patients. Similar to the other new oral anticoagulants, apixaban has not been extensively studied in various clinical scenarios including use in conjunction with neuraxial anesthesia. Apixaban also carries the same two black box warnings as rivaroxaban and dabigatran for risk of hematoma following spinal puncture, and increased stroke risk upon discontinuation. Therefore, patients should be counseled never to discontinue apixiban without first consulting a healthcare provider so that alternative anticoagulation may be initiated as needed. Other important counseling points to communicate to the patient include the option to take apixaban either with or without food, never to double up on doses, to immediately report signs and symptoms of bleeding, and to consult a healthcare provider prior to starting any new medications.21,31 Apixaban conversions To convert warfarin to apixaban, warfarin should be stopped, then once the patient’s INR is less than 2, apixaban should be started. If the oral strategy is used when converting from apixaban to warfarin, start warfarin and overlap with apixaban for at least 5 days and discontinue apixaban on day 5 or when the INR is 2-3. If the parenteral anticoagulant technique is used, start the parenteral anticoagulant 12 hours after the last apixaban dose, start warfarin the same day at the next standard administration time of apixaban and discontinue the parenteral anticoagulant after 5 days and when the patient’s INR is 2-3 for at least 24 hours.31 Bridging with apixaban is not quite as complicated as the other agents and only requires taking into account the bleeding risk of the procedure. If the oral technique is used and the procedure has a standard bleeding risk, apixaban should be discontinued 24 hours prior to surgery. For procedures with a high CONTINUING EDUCATION
bleeding risk, apixaban should be discontinued 48 hours prior to the procedure. If the parenteral anticoagulant technique is used, then apixaban should be stopped sometime prior to the recommendation for the oral technique and parenteral anticoagulation should be started 12 hours after the last dose of apixaban. The remainder of the bridging process is done identically to warfarin bridging, except that once the surgery is complete and there is adequate hemostasis the patient should be restarted on only apixaban 24 hours after the procedure.31 Table 4 Converting Dabigatran to Warfarin.16
Modified from Reed et al. Dabigatran UNC Health Care Guideline.
Table 5 Dabigatran Discontinuation Prior to Surgical Procedure.16
Modified from Reed et al. Dabigatran UNC Health Care Guideline.
Table 6 Factor Xa Inhibitor Reversal with Clotting Factors.3
Table 7 Converting Rivaroxaban to Warfarin.22
Modified from Reed et al. Rivaroxaban UNC Health Care Guideline.
In the Pipeline Although not currently approved for use in the United States, edoxaban is a promising new oral anticoagulant which has demonstrated noninferiority to warfarin in the prevention of stroke and systemic embolism in atrial fibrillation patients through the ENGAGE AF-TIMI 48 trial. In this study, patients with atrial fibrillation having a CHADS2 score of 2 or higher received either edoxaban 30 mg PO daily, edoxaban 60 mg PO daily or dose-adjusted warfarin. Both doses of edoxaban were found to be noninferior to warfarin in the prevention of stroke and systemic embolism (1.18% vs. 1.5% of patients per year for edoxaban 60 mg daily, hazard ratio 0.78 (0.63-0.99); P<0.001 for noninferiority and 1.61% vs. 1.5% of patients per year for edoxaban 30 mg daily, hazard ratio 1.07 (0.87-1.31); P=0.005 for noninferiority). Additionally, both doses of edoxaban demonstrated significantly lower rates of major bleeding versus warfarin.36 Through the Hokusai-VTE trial, edoxaban has also shown preliminary evidence for use in the treatment and recurrent risk reduction of VTE. In this trial, patients received either edoxaban 60 mg once daily (or 30 mg once daily if CrCl 30-50 mL/min, weight <60 kg, or concomitant use of a p-glycoprotein inhibitor) or dose-adjusted warfarin following initial heparin treatment. Results revealed edoxaban to be noninferior to warfarin in the prevention of recurrent, symptomatic VTE (3.2% vs. 3.5% of patients, hazard ratio 0.89 (0.7-1.13); P<0.001 for noninferiority) and found edoxaban CONTINUING EDUCATION
Oral Anticoagulants to be superior to warfarin for the primary safety endpoint of major bleeding.37 Should edoxaban gain FDA approval for use in the United States, this factor Xa inhibitor would offer several advantages to the other currently approved oral anticoagulants. Not only is edoxaban dosed once daily, but it may also be administered without regard to meals. Furthermore, edoxaban is not extensively metabolized through CYP3A4 pathways, thus offering the advantage of a decreased potential for drug interactions.38 Conclusion There are many factors to consider when evaluating use of the new oral anticoagulants. As was illustrated in this article, there are new technologies being developed which may make both monitoring and reversal of these agents possible in the future. These developments will bring more support from the prescribing community and much wider use of the new oral anticoagulants. As drug specialists, it is important for pharmacists to remain aware of any emerging developments and ensure that knowledge is disseminated to the healthcare professionals around them. It is hoped this article will provide a solid foundation of information on dabigatran, rivaroxaban and apixaban, and in so doing, allow the provision of safe and effective care.
Table 8 Rivaroxaban Discontinuation Prior to Surgical Procedure.22
Modified from Reed et al. Rivaroxaban UNC Health Care Guideline.
Fall 2015 • Arizona Journal of Pharmacy • 35
Oral Anticoagulants References
1. Holbrook A, Schulman S, Witt DM et al. American College of Chest Physicians. Evidence-based management of anticoagulant therapy: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012 Feb;141(2 Suppl):e152S-84S. doi: 10.1378/chest.11-2295. Review. 2. Product Information: Coumadin®, warfarin. Bristol-Myers Squibb Company, Princeton, NJ. Revised: October 2011. 3. Nutescu EA, Dager WE, Kalus JS et al. Management of bleeding and reversal strategies for oral anticoagulants: clinical practice considerations. Am J Health Syst Pharm. 2013 Nov 1;70(21):1914-29. 4. Douketis JD, Spyropoulos AC, Spencer FA et al. American College of Chest Physicians. Perioperative management of antithrombotic therapy: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012 Feb;141(2 Suppl):e326S-50S. 5. Gulseth MP, Wittkowsky AK, Fanikos J et al. Dabigatran etexilate in clinical practice: confronting challenges to improve safety and effectiveness. Pharmacotherapy. 2011;31(12):1232-49. 6. Product Information: Pradaxa®, dabigatran etexilate mesylate. Boehringer Ingelheim Pharmaceuticals, Ridge Ridgefield, CT. Revised: April 2014. 7. Product Information: Pradaxa®, dabigatran etexilate mesylate. Boehringer Ingelheim Pharmaceuticals, Ridge Ridgefield, CT. Revised: April 2014. 8. Connolly SJ, Ezekowitz MD, Yusuf S et al; RE-LY Steering Committee and Investigators. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med. 2009;361(12):1139-51. 9. Schulman S, Kearon C, Kakkar AK et al; RE-COVER Study Group. Dabigatran versus warfarin in the treatment of acute venous thromboembolism. N Engl J Med. 2009;361(24):2342-52. 10. Schulman S, Kakkar AK, Goldhaber SZ et al; RE-COVER II Trial Investigators. Treatment of acute venous thromboembolism with dabigatran or warfarin and pooled analysis. Circulation. 2014;129(7):764-72. 11. Schulman S, Kearon C, Kakkar AK et al; RE-MEDY Trial Investigators; RE-SONATE Trial Investigators. Extended use of dabigatran, warfarin, or placebo in venous thromboembolism. N Engl J Med. 2013;368(8):709-18. 12. Lexi-Drugs Dabigatran Drug Monograph. 13. Connolly SJ, Ezekowitz MD, Yusuf S et al; RE-LY Steering Committee and Investigators. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med. 2009;361(12):1139-51. 14. Wittkowsky AK. Novel oral anticoagulants and their role in clinical practice. Pharmacotherapy. 2011;31(12):1175-91. AND Davis EM, Packard KA, Knezevich JT et al. New and emerging anticoagulant therapy for atrial fibrillation and acute coronary syndrome. Pharmacotherapy. 2011;31(10):975-1016. 15. Gulseth MP, Wittkowsky AK, Fanikos J et al. Dabigatran etexilate in clinical practice: confronting challenges to improve safety and effectiveness. Pharmacotherapy. 2011;31(12):1232-49. 16. Product Information: Pradaxa®, dabigatran etexilate mesylate. Boehringer Ingelheim Pharmaceuticals, Ridge Ridgefield, CT. Revised: April 2014. 17. Eerenberg ES, Kamphuisen PW, Sijpkens MK et al. Reversal of rivaroxaban and dabigatran by prothrombin complex concentrate. Circulation. 2011; 124:1573-9. 18. Dager WE, Roberts AJ. Reversing dabigatran in a life-threatening bleed occurring during cardiac ablation with factor eight inhibitor bypassing activity. Crit Care Med. [Epub ahead of print] 2013 Mar 7. 19. Warkentin TE, Margetts P, Connolly SJ et al. Recombinant factor VIIa (rFVIIa) and hemodialysis to manage massive dabigatran-associated postcardiac surgery bleeding. Blood. 2012; 119:2172-4. 20. Schiele F, van Ryn J, Canada K et al. A specific antidote for dabigatran: functional and structural characterization. Blood. 2013 May 2;121(18):3554-62. 21. Smythe MA, Fanikos J, Gulseth MP et al. Rivaroxaban: practical CONTINUING EDUCATION
considerations for ensuring safety and efficacy. Pharmacotherapy. 2013;33(11):1223-45. 22. Product Information: Xarelto®, rivaroxaban. Janssen Pharmaceuticals, Titusville, NJ. Revised: March 2014. 23. Patel MR, Mahaffey KW, Garg J et al; ROCKET AF Investigators. Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med. 2011;365(10):883-91. 24. Eriksson BI, Borris LC, Friedman RJ et al; RECORD1 Study Group. Rivaroxaban versus enoxaparin for thromboprophylaxis after hip arthroplasty. N Engl J Med. 2008;358(26):2765-75. 25. Lassen MR, Ageno W, Borris LC et al; RECORD3 Investigators. Rivaroxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty. N Engl J Med. 2008;358(26):2776-86. 26. Bauersachs R, Berkowitz SD, Brenner B et al. Oral rivaroxaban for symptomatic venous thromboembolism (EINSTEIN). N Engl J Med. 2010;363(26):2499-510. 27. Büller HR, Prins MH, Lensin AW et al. Oral rivaroxaban for the treatment of symptomatic pulmonary embolism (EINSTEIN–PE). N Engl J Med. 2012;366(14):1287-97. 28. Barrett YC, Wang Z, Frost C et al. Clinical laboratory measurement of direct factor Xa inhibitors: anti-Xa assay is preferable to prothrombin time assay. Thromb Haemost. 2010; 104:1263-71. 29. Miyares MA, Davis K. Newer oral anticoagulants: a review of laboratory monitoring options and reversal agents in the hemorrhagic patient. Am J Health-Syst Pharm. 2012; 69:1473-84. 30. Andexanet alfa: FXa Inhibitor Antidote. Retrieved from http://www.portola.com/clinical-development/andexanet-alfa-prt4445-fxa-inhibitor-antidote. 31. Product Information: Eliquis®, apixaban. Bristol-Myers Squibb Company, Princeton, NJ. Revised: March 2014. 32. Granger CB, Alexander JH, McMurray JJ et al; ARISTOTLE Committees and Investigators. Apixaban versus warfarin in patients with atrial fibrillation. N Engl J Med. 2011;365(11):981-92. 33. Lassen MR, Raskob GE, Gallus A et al; ADVANCE-2 investigators. Apixaban versus enoxaparin for thromboprophylaxis after knee replacement (ADVANCE-2): a randomised double-blind trial. Lancet. 2010;375(9717):807-15. 34. Lassen MR, Raskob GE, Gallus A et al. Apixaban or enoxaparin for thromboprophylaxis after knee replacement. N Engl J Med. 2009;361(6):594-604. 35. Lassen MR, Gallus A, Raskob GE et al; ADVANCE-3 Investigators. Apixaban versus enoxaparin for thromboprophylaxis after hip replacement. N Engl J Med. 2010;363(26):2487-98. 36. Giugliano RP, Ruff CT, Braunwald E et al. ENGAGE AF-TIMI 48 Investigators. Edoxaban versus warfarin in patients with atrial fibrillation. N Engl J Med. 2013;369 (22):2093-104. 37. Büller HR, Décousus H, Grosso MA et al. Edoxaban versus warfarin for the treatment of symptomatic venous thromboembolism. N Engl J Med. 2013;369(15):1406-15. 38. Davis EM, Packard KA, Knezevich JT et al. New and emerging anticoagulant therapy for atrial fibrillation and acute coronary syndrome. Pharmacotherapy. 2011;31(10):975-1016.
ACPE UAN# 0100-0000-15-077-H01-P; 0100-0000-15-077-H01-T In order to receive full CPE credit you must turn in a completed evaluation form pg 38. The Arizona Pharmacy Association is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.
Oral Anticoagulants
I.
CONTINUING EDUCATION QUIZ QUESTIONS New Oral Anticoagulants: A General Overview of Dabigatran, Rivaroxaban and Apixaban ACPE UAN# 0100-0000-15-077-H01-P; 0100-0000-15-077-H01-T
1. Which of the following medications must be stored in its original container due to the potential for degradation secondary to moisture? A. Rivaroxaban B. Dabigatran C. Apixaban D. Warfarin 2. In the RE-LY trial, which of the following types of bleeding was found to be significantly increased with dabigatran 150 mg twice daily versus warfarin? A. Minor bleeding B. Intracranial bleeding C. Gastrointestinal bleeding D. Life threatening bleeding 3. Which doses of rivaroxaban are important to take with food in order to increase the bioavailability of the drug? A. All doses B. Any dose ≥15 mg daily C. Any dose ≥20 mg daily D. Only doses of 15 mg twice daily 4. Apixaban is currently approved for use in all but which of the following indications? A. Risk reduction of recurrence of DVT/ PE B. DVT prevention in total hip surgery C. DVT prevention in total knee surgery D. Stroke and systemic embolism prevention in non-valvular AF 5. Which of the following medications may be crushed and administered through nasogastric tubes? A. Apixaban B. Rivaroxaban and apixaban C. Dabigatran and rivaroxaban D. Dabigatran and apixaban 6. Which of the following patients taking apixaban for stroke and systemic embolism prevention in AF would require a dosage reduction to 2.5 mg PO BID? CONTINUING EDUCATION
A. An 83 year old female weighing 45 kg with a serum creatinine of 0.9 mg/dL B. A 42 year old male weighting 83 kg with a serum creatinine of 1.2 mg/dL C. A 31 year old female weighing 59 kg with a serum creatinine of 1.6 mg/dL D. A 74 year old female weighing 70 kg with a serum creatinine of 1.8 mg/dL 7. Which of the clotting factors would be the best agent to use for reversal of rivaroxaban? A. PCC3 B. PCC4 C. rFVIIa D. aPCC
11. In a patient currently receiving apixaban that needs a surgical procedure with a standard bleeding risk and is using the oral technique for bridging, how soon before the procedure should apixaban be stopped? A. 36 hours B. 24 hours C. 48 hours D. 72 hours 12. What would be the worst agent for the reversal of dabigatran? A. PCC3 B. PCC4 C. rFVIIa D. aPCC
13. For which indication is the recommended INR during warfarin therapy 8. What laboratory monitoring tech- 2.5-3.5? nique is commonly used for enoxa- A. Mechanical Mitral Valve B. Mechanical Aortic Valve parin, unfractionated heparin and C. Bioprosthetic Mitral Valve fondaparinux, but would require a specific calibration assay to be used D. DVT/PE Treatment for rivaroxaban monitoring? 14. What is the minimum duration a A. Ecarin Clotting Time parenteral anticoagulant should be used B. Thromboelastography prior to initiating dabigatran for the C. Chromogenic Antifactor Xa treatment of VTE? D. Plasma Diluted Thrombin Time A. 2 days 9. When switching from warfarin to B. 3 days one of the new oral anticoagulants, C. 4 days D. 5 days which agent requires waiting until the patient’s INR is less than 3? A. Rivaroxaban B. Apixaban C. Dabigatran D. Edoxaban
10. What is the name of the recombinant product currently in trials that acts as a factor Xa decoy and if approved could be used for the reversal of rivaroxaban and apixaban? A. aDabi-Fab B. Fab-Ulous FXa C. AlphaReverse D. Andexanet Alfa
15. The ARISTOTLE trial demonstrated apixaban to be __________ to warfarin for the primary efficacy endpoint of stroke and systemic embolism prevention and ___________ to warfarin for the primary safety endpoint of major bleeding in patients with atrial fibrillation A. Superior, inferior B. Inferior, inferior C. Inferior, superior D. Superior, superior
Fall 2015 • Arizona Journal of Pharmacy • 37
Continuing Education Answer Sheet: New Oral Anticoagulants: A General Overview of Dabigatran, Rivaroxaban and Apixaban
ACPE UAN# 0100-0000-15-077-H01-P; 0100-0000-15-077-H01-T Activity accredited date: 09/01/2015 Expiration date: 09/01/2018. This activity is accredited for 1 hour of CPE credit (CEUs). In order to qualify for ACPE credit, participants must achieve a grade of 70% or above on the quiz and submit a completed activity evaluation. Complete the quiz / eval below or take the quiz online at: azpharmacy.org/ajp_fall/anticoagulants CE Assessment Answers - Please circle your answers (one answer per question.) 1. a. b. c. d. 8. a. 2. a. b. c. d. 9. a. 3. a. b. c. d. 10. a. 4. a. b. c. d. 11. a. 5. 6. 7.
a. a. a.
b. b. b.
c. c. c.
d. d. d.
12. 13. 14. 15.
a. a. a. a.
Questions on page 40. b. c. d. b. c. d. b. c. d. b. c. d. b. b. b. b.
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Fall 2015 • Arizona Journal of Pharmacy • 39
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