Winter 2014 Vol. 6, No. 1
Arizona Journal of Pharmacy
THE OFFICIAL PUBLICATION OF THE ARIZONA PHARMACY ASSOCIATION Brought to you by Pharmacy Network of Arizona
A year of prospects, possibilities, and promise.
CONTINUE THE TRADITION Established in 1958, the Bowl of Hygeia Award recognizes pharmacists who possess outstanding records of civic leadership in their communities and encourages pharmacists to take active roles in their communities. The award has been presented to a deserving Arizona pharmacist every year since inception. The Arizona Pharmacy Association, working together with APhA, NASPA, and the APhA Foundation, is engaged in a fundraising campaign to fully endow the Bowl of Hygeia in perpetuity. Please make a donation today at http://www.aphafoundation.org/azpabowlers
Arizona Journal of Pharmacy
THE OFFICIAL PUBLICATION OF THE ARIZONA PHARMACY ASSOCIATION Brought to you by Pharmacy Network of Arizona
Vol. 6, No. 1
Winter 2014
In This Issue Columns
President’s Message CEO’s Message Academy News • Community Practice Academy • Geriatric Care Academy • Health-System Academy • Managed Care Academy • Student Pharmacist Academy • Technician Academy
2 3 29 29 30 30 31 31
Featured Articles
Perspectives from Within: Mock Interviews for Student Pharmacists at the AzPA Annual Convention Developing, Expanding, and Improving Pharmacy Residency Programs in Arizona: Symposium and Workshop Let it Snow! A Look Back - Botanical Print Time Capsule Ketorolac: The Best Analgesic for Your Grandmother? The Use of Tranexamic Acid in Orthopedic Surgery Health-System Pharmacy Leadership Forum Update
Departments
New Members Association News PAPA Legislative Update Arizona State Board of Pharmacy Feature Pharmacist • Expanding Patient Access to Pharmacists Drug Information Question Student Perspective • Improving Patient Adherence through Medication Synchronization and the Appointment-Based Model Continuing Education
13 15 16 17 17 18 20 23 4 5 8 9 10 12 24 26 32
Editor
Kelly Ridgway, R.Ph. Chief Executive Officer
www.azpharmacy.org
Managing Editor
Janet Weigel Marketing and Communications Manager
Editorial Board
Whitney Rice, Pharm.D. Leslie Rodriguez, Pharm.D.
Christi Jen, Pharm.D. Nicole Romney, Pharm.D.
Winter 2014 • Arizona Journal of Pharmacy • 1
President’s Message
So many ways to support your profession!
Ray Clark, Pharm.D. AzPA President
I hope everyone enjoyed a great holiday season. As we look forward to the year ahead I want to remind everyone of just a few of the many ways in which you can play an important role in supporting your profession during 2014. First and foremost, please consider making a donation to the Pharmacists Political Action Committee of Arizona (PharmPAC). Making a donation to PharmPAC has never been easier since it can now be taken care of completely online at the AzPA website (www. azpharmacy.org). Annual memberships start at just $10 and membership levels escalate all the way up to the prestigious Chairman’s Club ($500) in which members are invited to exclusive political events. An easy way to support our profession is to buy gift cards from the Arizona Pharmacy Foundation’s (APF) gift card program. APF offers gift cards from approximately 50 retail stores as well as several major grocery store chains. You will receive the full value of whichever gift card you select since the APF is able to buy the cards at a discount. In other words, participation in this program will cost you no extra money if you were planning to make a purchase at a local retailer anyway! Please refer to the APF page on our website for a list of retailers and more details concerning this awesome program.
You can support your profession in our state by encouraging your friends, family, and colleagues to use the Amazon.com link on the AzPA website when making online purchases. Since you do not have to be a member of the AzPA to use this link this is also a great way to get those who have never been a member of the AzPA to visit our website for the first time. When it comes to supporting your profession I want to remind everyone to not forget about their pharmacy school. Try to donate to your school every year and keep in mind that most university rankings take into consideration the percent of alumni that have donated to their school in the past year. Consequently, an annual donation is also a good way to increase the “currency” of your hard earned degree. Your school is able to accept donations in the form of company stock so this may be a great way to avoid paying capital gains tax and still make a substantial contribution to your alma mater. (Of course, please consult your tax advisor first regarding your particular financial situation.) Another great way to support your school is to volunteer to be a preceptor. Even if Arizona is a long way from where you went to pharmacy school you may be surprised by how many students are willing to travel across the country to train in Arizona, especially during the winter! Were you active in a student organization during pharmacy school? If so, then consider giving the current student chapter of that organization a helping hand. Financial support is always welcome but I am sure that just volunteering to be a speaker or helping out at their next event would be very much appreciated.
An interesting option for supporting pharmacy is to include the Arizona Pharmacy Foundation and your school as partial beneficiaries in your will. This move would cost you no money now and could help our profession in a big way down the road. Thank you so much to everyone who participated in last quarter’s contest for the free Harkins movie passes. The response was overwhelming and I was thrilled to hear from AzPA members from all over our great state. I would like to congratulate Ryan Gries for winning the contest by being the first member to correctly name the official colors of the Kappa Psi Pharmaceutical Fraternity as scarlet and cadet gray. In honor of the Arizona Pharmacy Foundation, I would like to offer two free Harkins movie passes to the first AzPA member that emails me at ray.nelson.clark@gmail.com with at least three activities that the Arizona Pharmacy Foundation sponsors each year. Everyone should be able to participate in this quarter’s challenge since the answers can easily be found on our outstanding website. As you make plans for 2014, I hope you include one or more of these suggestions for supporting your profession. Your contributions, large or small, really will make a difference. 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. The Voice of Pharmacy in Arizona
2 • Arizona Journal of Pharmacy • Winter 2014
CEO’s Message
Join us in 2014 As I look back on 2013 I am proud of the progress our profession has made toward provider status. For the first time, and in a meaningful way, all national pharmacy associations are uniting to make provider status a reality. They are bringing a genuine interest, coordinating meetings, and devoting financial resources to get this done. The Arizona Pharmacy Association is a member of NASPA (National Alliance of State Pharmacy Associations) and its motto is “together we are stronger”. As I think about the meaning of these words, I believe they should be applied to our entire profession as we push for provider status. First and foremost we are pharmacists, no matter our practice setting, and it is time for us to come together not just in discussion but in action. The discussions, studies, pilot projects, and meetings have been helpful but we have the data to show that pharmacist clinical services provide value. For this reason we need to be formally recognized as members of the health care team. The Arizona Pharmacy Association will be pushing ahead to do what we can on a state level in our pharmacy practice act to recognize pharmacists as providers, while aiding the national efforts. There are a number of different ways you can contribute to this endeavor: • Participate in the monthly legislative affairs calls to provide input and insight to our approach • Call or write your state legislators to inform them on the initiative • Run for the AzPA Board of Directors • Support AzPA and the schools of pharmacy in Arizona at Pharmacy Day at the Capitol • Make a contribution to the PharmPAC (Pharmacists Political Action Committee of Arizona) • Maintain your state and national
association memberships • Run for state legislator (Did you know Arizona does not have a pharmacist serving at the state capitol?) AzPA has a number of other exciting activities planned for 2014. • February 12, 2014: Pharmacy Day at the Capitol - This is an opportunity for pharmacy professionals and the state legislators to meet and interact during the legislative session, experience the services pharmacists provide to our community, and discuss current issues relating to pharmacy and health care. • February 22, 2014: Arizona Pharmacy Symposium Presented by the Arizona Pharmacy Foundation and Pharmacists Assisting Pharmacists of Arizona (PAPA), this day-long event features continuing pharmacy education programs, presentation of the 2014 Cardinal Health GenerationRx Champions Award, induction of a new class of honorees into the Arizona Pharmacy Hall of Fame, and announcement of the 2014 Llyn Lloyd Service to Pharmacy Scholarship winners. • March 7 to 9, 2014: The University of Arizona 47th Annual Southwestern Clinical Pharmacy Seminar - This prestigious three-day clinical meeting will offer approximately 12 hours (1.20 CEUs) of continuing pharmacy education. • April 2014: Law on the Links Golf Tournament - A unique continuing pharmacy education activity combines an 18-hole round of golf with case law scenarios and pharmacy statutes/regulation updates. Proceeds benefit the Llyn Lloyd Service to Pharmacy Scholarship Fund. • June 26-29, 2014: Annual Convention - The four-day annual
Kelly Ridgway, R.Ph. AzPA CEO
convention provides continuing education, social activities, and networking opportunities for pharmacy professionals of all experience levels. Educational sessions focus on pharmacy topics pertinent to a variety of patient populations. • October 25, 2014: Fall Pharmacy Conference - A day-long clinical meeting offering approximately 6.0 hours (0.60 CEUs) of continuing pharmacy education for pharmacists and pharmacy technicians. Certificate Training Programs: • Anticoagulation: June 26, 2014 and November 14, 2014 • Diabetes: January 24, 2014 and September 26, 2014 • Immunization: June 26, 2014 and October 24, 2014 • MTM: June 26, 2014 • Psychiatric: March 7, 2014 and October 24, 2014 • Women’s Health: Winter 2014 I hope to see all of you at one or more of these events. Take advantage of the networking opportunities and learning in an interactive environment with your colleagues from around the state. “There are few things more pathetic than those who have lost their curiosity and sense of adventure, and who no longer care to learn.”
Gordon B. Hinckley Way to Be! 9 Rules For Living the Good Life
Winter 2014 • Arizona Journal of Pharmacy • 3
New Members
WELCOME NEW MEMBERS PHARMACISTS
Kevin Carrasco Alok Naik Brian Park Preeti Patel Nuri Tawwab Bernadette Aragon Tina Aramaki Christopher Casey Jackie Cavanagh Elizabeth Craig Usi Desai Rich Gutoski Laura Hansbury Apral Jones-Ford Monica Krogh Gilbert Limon Sunil Murthy Stephanie Sanders Brian Schulman Ashley Tritz Megan Vaughn Tim Vitullo Jamie Zacher Alexandra Spence Nathan Spence Ahmed Aljabri Cassandra Ehrlich Cole Sloan ASSOCIATES Mark Herriot Dave Manchester TECHNICIANS Kimberly Alexander Mike Cochran Deb Harper Pic Hill Bre Johnson Pam Koepke Grant Metcalf Gwendolyn Payton Amber Ritter
STUDENT PHARMACISTS Aliyah Abdul-Rasheed Ayah Ahmed Evellyn Ancheschi Alison Arpaia Meghan Arquette Kim Azari Lola Bacer Bernis Argam Begijan Garrett Berger Taness Billington Jeffrey Blaskowsky Jessica Browne Julie Brozio Bianca Camacho John Cao Vicki Chang Dieu Chau Ramon Chavez Erik Coffman Nathan Crapo Merta Cushing Benita Daniel Quyen Dao Brittney Dewey Sarah Dodge Nicole Dooda Osamah Eljerdi Cody Elmer Linzee Empens Ali Flath Corey Frahm Sierra Fung Andrew Garcia Kelsey Garlick Michael Goldberg Venessa Gonzalez Kellie Goodlet Vidhi Gupta Mayra Guzman Cody Hansen Bonita Harper Natalie Hashman Jackie Hu Kammi Humed Ye Huo
4 • Arizona Journal of Pharmacy • Winter 2014
Sarah Huynh Mandy Hwang Mika Jankowski Paul Kalandos Kyle Kennedy William Kennedy James Ketterer Raymond Kho Christie Kim Evelyn Kim Sarah Kim Rick Lasica Stephanie Lawson Jane Lee Shelby Lehew Alex Leonard Michelle Leong Kenneth Leutz Darren Lew Eva Liang Grace Lin Michelle Lin Ashley Loy Nathan Lunt Monica Malapit Evan Mallory Adam Mesa Marc Miller Sima Molla-Hosseini Armando Morales Gabriel Navoa Cindy Neroni Linda Nguy An Nguyen Debbie Nguyen Kim Nguyen Lily Nguyen Jason Nguyen
Sarah Nguyen Tan Nguyen Nicholas Ong Reema Patel Giau Phan Christine Phu Adrianne Remigio Jessica Rodriguez Carrie Roth Kelsey Royball Tyler Ruddy Crystal Salgado Andrew Sam Shannon Sampley Jared Sivinski Yung Song Preston Stoddard Yazan Sweilem Quang Tien Madeline Tompkinson Dany Trambley Vi Tran Daniel Trinh Annie Truong Thao Truong Ron Velasquez Daniel Vergel de Dios Michael Voight Cassandra Votruba Becky Weber Sara Weinstein Josh Whitenack Nick Wong Anny Wu Lily Yam Jingxin Yang Andrea Yim Julie Zappia
Association News Wear AzPA to Work Day! And the winners are......
Congratulations to the The Medicine Shoppe in Tucson and the Mayo Clinic Scottsdale Campus. These two pharmacy workplaces won the inaugural Wear AzPA to Work Day contest. Each group of employees who wore their AzPA shirts to work on Wednesday, October 23, 2013 has won a free lunch on AzPA! Thank you, too, to the students at Midwestern University Collge of Pharmacy Glendale for supporting pharmacy by wearing their AzPA shirts on campus. There will be another opportunity to win lunch for your pharmacy in the spring so watch the AzPA website for the announcement. You can get in on the spirit and support pharmacy in Arizona by wearing your AzPA polo or tee shirt to work, to school, or just out and about. We have styles for both men and women in a variety of sizes. Polos are available in a rainbow of colors. Order yours online from the AzPA Store at www.azpharmacy.org.
Mayo Clinic Scottsdale Campus: (left to right) Jay Patel, Sarah Minor, Art West, Erik Coffman, and Scott Hardy.
The Medicine Shoppe: (left to right) Jenn Poist, Barb Lampkin, Deb Van Sant, Greg Rogan, and Lupe Rosario
Midwestern University College of Pharmacy Glendale students show their support with AzPA on Campus.
Cheers for Volunteers! The Arizona Pharmacy Association staff is here to support YOU - our members. We acknowledge the contributions of the volunteers who have made a difference for our organization and their fellow pharmacy professionals. Thank you for all you do! Nicole Runge Reg Roy Judi Day Angela Hamman Marben Mopera Stacy Haber Christi Jen Elizabeth Pogge Kristin Calabro Lindsay Davis Phil Schneider
Brian Erstad Scott Hardy Mindy Burnworth Carol Rollins Hillary Aphaisuwan Josh Kramer Betty Louton Sophia Galloway Daniel Doetsch Grace Akoh-Arrey Erin Raney Lisa Goldstone Kristen Ellis Tracy Thao Lin Nicole Murdock Lauren Miller Justin Brock Bob Waski Deb Van Sant Greg Rogan
Alexandra Trinh Cassandra Ehrlich Virginia Boomershine Kristen Ching Nicole Kitts Whitney Rice Daniel Burgos Lou Caldwell Sabrina Pennock Pritesh Patel Kristyn Straw
Winter 2014 • Arizona Journal of Pharmacy • 5
Association News APF News Student Leadership Conference The 4th Annual AzPA Student Leadership Conference is slated for Saturday, January 25, 2014. To be held in Tucson, this day-long conference aims to develop and grow future pharmacy leaders by empowering participants to: 1. Recognize the qualities of leadership that are exhibited by pharmacists in everyday practice. 2. Understand your responsibility as a leader in the profession of pharmacy, and in your community. 3. Identify strategies to develop leadership skills by discerning the differences between a manager and a leader. 4. Identify resources in your practice setting, community, local, and state government to empower you to address problems and provide solutions. 5. Understand the importance of state association membership and involvement. Attendance of the AzPA Student Leadership Conference is by application only and is limited to 40 individuals. Third-year University of Arizona College of Pharmacy students and secondyear Midwestern University College of Pharmacy-Glendale students who are AzPA members-in-good-standing may apply. Attendees will be chosen based on their experience and the strength of their essay. APF Pharmacy Symposium The Arizona Pharmacy Foundation arizona presents the Arizona Pharmacy Pharmacy Symposium Symposium on Saturday, February 22, 2014. The day-long event will be held at the new Kroc Corps Community Center in Phoenix and will offer continuing pharmacy education on topics focused on community outreach and patient education. In addition, the Cardinal Health GenerationRx Champions Award honoring an Arizona pharmacist who has demonstrated outstanding commitment to raising awareness of the dangers of prescription drug abuse among the general public and the pharmacy community will be presented. The winners of the 2014 Llyn Lloyd Service to Pharmacy Scholarship will also be announced. Check the AzPA website for more information. New Date for Law on the Links Save the date for the Arizona Pharmacy Foundation Golf Tournament and the return of “Law on the Links”. The popular best-ball scramble golf event with continuing education credits for pharmacy law is back on Thursday, April 11, 2014. Location and details are forthcoming but plan to join us for a great day of golf and CE, all benefiting the APF Llyn Lloyd Service to Pharmacy Scholarship Fund. 6 • Arizona Journal of Pharmacy • Winter 2014
PD@C Pharmacy Day at the State Capitol
Wednesday, February 12, 2014 9:00 am to 1:00 pm
I. NEW FOR 2014! Join AzPA for CE and continental breakfast prior to PD@C. Advocating for the Profession Continuing Pharmacy Education Law Activity 9:00 am to 10:30 am Arizona State Board of Pharmacy Board Room 1616 W. Adams Street Suite 120 Phoenix, Arizona 85007 Admission free courtesy of our sponsor II. Arizona State Capitol Senate Lawn 11:00 am to 1:00 pm 1700 West Washington Phoenix, Arizona 85007 This is an opportunity for pharmacy professionals and the state legislators to • Meet and interact during the Legislative Session • Experience the services pharmacists provide to our community • Discuss current issues relating to pharmacy and health care Arizona State Legislators and their staffs are invited to join pharmacists and student pharmacists on the Senate Lawn for lunch and to visit health screening and informational booths, including: • Immunizations • Medication Therapy Management • Poison Center • Smoking Cessation • Blood Glucose Screenings/Diabetes • Blood Pressure Screenings • Asthma Screenings • Drug Take Back
Association News MARK YOUR CALENDAR FOR THESE UPCOMING CERTIFICATE PROGRAMS AND CONFERENCES CERTIFICATE TRAINING PROGRAMS Psychiatric Certificate Program
developed by the Arizona Pharmacy Association The Psychiatric Certificate Program (PCP) is a practice-based activity designed for pharmacists in all practice settings. The intent of this training program is to provide additional training in the area of psychiatric pharmacy to enhance pharmacists’ clinical knowledge that can be applied directly to the patients they serve. Program Dates: Friday, March 7, 2014 Friday, October 24, 2014
Immunization Training Program developed by the Arizona Pharmacy Association This certificate program is a practice-based educational activity that teaches pharmacists the skills necessary to become primary sources for vaccine education, and administration. This program reviews the reviews legal and regulatory issues pharmacists must consider before starting an immunization program and focuses on practice implementation. Program Dates: Thursday, June 26, 2014 Friday, October 24, 2014 Anticoagulation Certificate Program developed by the Arizona Pharmacy
Association This certificate program is a comprehensive program designed to provide pharmacists and nurses with the basic knowledge and skills necessary to care for patients taking anticoagulation therapies. Program Dates: Thursday, June 26, 2014 Friday, November 14, 2014
Pharmacist & Patient-Centered Diabetes Care
developed by the American Pharmacists Association This certificate program is an intensive educational experience designed to equip pharmacists with the knowledge, skills, and confidence needed to provide effective, evidence-based diabetes care. Five self-study modules provide comprehensive instruction in current diabetes concepts and standards of care. Program Dates: Friday, January 24, 2014 Friday, September 26, 2014
Delivering Medication Therapy Management Services developed by the
American Pharmacists Association This certificate program is an innovative and interactive certificate training program that explores the pharmacist’s role in providing MTM services to patients. Pharmacists have a tremendous opportunity to receive reimbursement for monitoring and improving medication use in patients with complex medication regimens. Program Date: Thursday, June 26, 2014
arizona Pharmacy Symposium
conferences Arizona Pharmacy Symposium Saturday, February 22, 2014 8:00 am to 5:00 pm 6.0 contact hours (0.60 CEUs) Location: Phoenix, Arizona
47th Annual Southwestern Clincial Pharmacy Seminar Friday, March 7, to Sunday, March 9, 2014 Three-day event Location: Sheraton El Conquistador, Tucson, Arizona 12.0 contact hours (1.20 CEUs)
Presented in partnership between The University of Arizona College of Pharmacy, the Arizona Pharmacy Association, and the AzPA Health-System Academy, the Arizona affiliate of ASHP
Arizona Pharmacy Foundation Law on the Links Golf Tournament Friday, April 11, 2014 1.5 contact hours(0.15 CEUs) Location: Phoenix, Arizona :
ERS Annual Convention VID O PR Thursday, June 26 to AS S T IS Sunday, June 29, 2014 AC T RM A cHANGing Location: PH a E Wigwam Resort m Litchfield Park, Arizona e
15.0 contact hours (1.50 CEUs). More than 30 continuing pharmacy education programs offered
Fall Pharmacy Conference Saturday, October 25, 2014 Location: Phoenix, Arizona 6.0 contact hours (0.60 CEUs) Visit www.azpharmacy.org for complete details on all conferences and certificate training programs.
Winter 2014 • Arizona Journal of Pharmacy • 7
PAPA Pills Anonymous Most people know about the original 12 step program, AA-Alcoholics Anonymous, which has been around since 1935. Their book, of the same name, was written in 1939. Since then, numerous 12 step programs have come about (NA-Narcotics Anonymous, CA-Cocaine Anonymous, HA-Heroin Anonymous, etc.) NA, Narcotics Anonymous, which started in the 1950’s did not publish their book until 1982. Pills Anonymous has recently published their book, There is a Solution: the Twelve Steps and Twelve Traditions of Pills Anonymous (copyright 2013) Pills Anonymous, World Services, Chandler, Arizona. What you may not know is that many of the stories and a good deal of the work that went into publishing this new, groundbreaking book are from Arizona pharmacists, physicians and other local people who are successfully engaged in their own recovery programs. A good way for someone to decide if they have a problem with pill addiction is to answer the “Pills Anonymous 20 questions” - designed to help you determine if you are a pill addict: 1. Has your doctor, spouse, or anyone else expressed concern about your use of medications? 2. Have you ever decided to stop taking pills only to find yourself taking them again contrary to your earlier decision? 3. Have you ever felt remorse or concern about taking pills? 4. Has your efficiency or ambition decreased since taking pills? 5. Have you established a supply for purse or pocket or to hide away in case of emergency? 6. Have you ever been treated by a physician or hospital for excessive use of pills (whether or not in combination with other substances)? 7. Have you changed doctors or pharmacies for the purpose of maintaining your supply? 8. Have you received the same medication from two or more physicians or pharmacists at approximately the same time? 9. Have you ever been turned down for a refill? 10. Have you ever taken other peoples pills with or without their permission or obtained them illegally? 11. Have you taken the same pain or sleep medication for a prolonged period of time only to find you still have the same symptoms? 12. Have you ever informed your physician as to which pill works best at which dosage and had them adjust the prescription to your recommendations? 13. Have you increased the dosage, strength, or frequency of your pills over the past months or years? 8 • Arizona Journal of Pharmacy • Winter 2014
14. Are your pills quite important to you; e.g., do you worry about refills long before running out? 15. Do you become annoyed or uncomfortable when others talk about your use of pills? 16. Have you or anyone else noticed a change of personality when you take your pills, or when you stop taking them? 17. Have you ever taken your medication before you had the associated symptom? 18. Have you ever been embarrassed by your behavior when under the influence of your pills? 19. Do you ever sneak or hide your pills? 20. Do you find it impossible to stop or to go for a prolonged period without your pills? If you answered yes to three or more of these questions, then our experience would indicate that you may be one of us. Reprinted and adapted with permission from There’s More to Quitting Drinking than Quitting Drinking by Dr. Paul O. © 2013 Pills Anonymous World Service For more information about Pills Anonymous and the book, you can go to : http://www.pillsanonymous.org/book/the-book/ For information about how to find a PA meeting in your area: http://www.pillsanonymous.org/meetings/find-a-meeting/
NEED GIFT CARDS?
PURCHASE THEM FROM THE ARIZONA PHARMACY FOUNDATION AND SUPPORT PHARMACY EDUCATION! vISIT THE AzPA WEBSITE TO DOWNLOAD A COMPLETE LIST OF AVAILABLE VENDORS. www.azpharmacy.org
Legislative Update The Legislative Session is just around the corner. AzPA is gearing up for another productive session working hard to protect and advocate for the profession of pharmacy in Arizona. AzPA will be monitoring all the bills and vetting each that pertain to the practice of pharmacy through our Legislative Affairs Committee to decide what position to take on each bill. In each given legislative session there can be more than 50 bills that impact pharmacy in various way. In addition to the bills we will be monitoring this session we also plan to introduce legislation: • Fair Audit Bill: This bill will focus on correcting unfair auditing practices that are negatively impacting community pharmacists. We will be working with the respective stakeholders over the next couple of months to address our concerns and iron out the language of the bill. AzPA has a task force that is meeting on a regular basis to provide feedback to the CEO and the AzPA lobbyist as new issues arise. • Pharmacists as Providers: This bill will focus on recognizing pharmacists as health care providers within our pharmacy practice act. This bill will not mandate payment for services nor will it increase our scope of practice. The bill is aimed at naming pharmacists in the section of the statutes that refer to medical practitioners as it aligns with our current scope of practice. Please plan to attend the 2014 Pharmacy Day at the State Capitol - PD@C - on Wednesday, February 12, 2014. This is a great opportunity to meet with your state legislators and impress upon them the importance of the role of pharmacists on the health care team. Student pharmacists from the U of A and Midwestern will be staffing booths on pharmacist-provided services. Lunch will be served between 11 am and 1 pm. Arrive early at 9 am for a free law CE on Advocating for the Profession. Details are on page 6. The AzPA Legislative Affairs Committee meets via teleconference at 12 noon on the first Wednesday of the month. All AzPA members are welcome to attend the monthly meetings. If you are interested in joining the discussions, contact Laura Carpenter, Legislative Committee Chair, at legislative@azpharmacy.org or Kelly Ridgway, AzPA CEO, at kelly@azpharmacy.org. Laura Carpenter AzPA Legislative Affairs Committee Chair legislative@azpharmacy.org
Cactus Wren Training Program “Leading the Way” in “Changing Lives One Student at a Time”
Approved by the Department of Health, Arizona State Board of Nursing and Licensed Vocational School by the Arizona State Board for Private Post Secondary Education
ch
$ 1080
Course Offerings:
• Nursing Assistant Classes Includes CPR/FA, TB Testing, fingerprinting application with • Pharmacy Technician Text Books • Phlebotomy Technician Small classes with maximum of 10 students per class. • Caregiver Training • CPR and First Aid 1833 W Main St. Suite 138 • IV certification for LPN’S Mesa, AZ, 85201 • Assisted Living Facility Manager Caregiver CEU’s and Manager CEU’s • Call Now! • Assistant Statement of Deficiencies Phoenix: 602-741-5526 • Group home Start-up consultation 602-633-2730 New Offerings • Certified Medication Aide for CNAs • Group Home Start Up Class/Assisted Mesa: 480-751-6881 Living Facility Manager Fax: 480-7516886 • Direct Care Worker for DDs, AHCCCS residents ch
Offering Weekend Classes
CNA and Pharmacy Technician Classes
FINANCIAL AID AVAILABLE FOR QUALIFIED STUDENTS Registration online is Available www.cactuswrenhomecare.com
PhoenixLocation: Location: Phoenix 11024 N N 28th 28th Dr. Dr. Suite Suite265 265 11024 Phoenix,AZ AZ85029 85029 Phoenix,
East EastValley ValleyLocation: Location: 1833W. W. Main 1833 MainSt. St.Suite Suite138 138 Mesa, Mesa,AZ AZ85201 85201
Pharmacists Say it Best … “PTCB Certified Pharmacy Technicians continually demonstrate the highest excellence of professional performance across practice settings. I’ve had the pleasure to work with PTCB CPhTs and rely on their support to my pharmacist activities in providing patient care. They are among the best qualified to participate in operational functions of dispensing and inventory management. Our pharmacy simply couldn’t function without our team of PTCB CPhTs.” —Jeanie Barkett, RPh, Long Term Care Pharmacy Lead Pharmacist, Providence Specialty Pharmacy Services, Portland, OR
Do it for your pharmacy. Do it for your patients. Do it for you. Encourage your technicians to become PTCB certified today! Candidates may apply to take the Pharmacy Technician Certification Exam online at www.ptcb.org.
Certification Excellence 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 Health-System Pharmacists, and the National Association of Boards of Pharmacy.
Jeff Gray, R & R Partners, AzPA Lobbyist CONNECT ONLINE:
Winter 2014 • Arizona Journal of Pharmacy • 9
Arizona State Board of Pharmacy Dressed to Kill?? submitted by Richard Cielinski, R.Ph.
They stand out. Their very appearance causes you to turn and take a second look at them. Do you recognize them? Have you possibly been treated by them? You see them everywhere – doctors, nurses, medical technicians, pharmacists, pharmacy technicians and others in scrubs. They shop in them. They eat at fast food restaurants in them. They grocery shop in them and they wear them home. But, what you can’t see on these scrubs are the bacteria that could possibly sicken or even kill a person. But, who’s who? Is the person actually harboring any infectious bacteria in their scrubs? A recent study conducted by the Department of Microbiology and Immunology at the University of Arizona and published in the article, ‘New Study Reveals Scrubs are Carriers of Deadly Bacteria’, by Charles Kinder, M.D., reveals that, “Sixteen million health care professionals wear scrubs in the workplace every day.” “92 percent of scrubs worn by hospital personnel are carrying dangerous bacteria including MRSA, VRE and Clostridium difficile, or C.diff., by the end of every work shift, 79 percent of unwashed operating room scrub swatches were contaminated with some type of Gram-positive cocci and 69 percent tested positive for coliform bacteria, three of which were E.coli.” In an article written by a health writer from MSNBC, it was pointed out that a new study in the American Journal of Infection Control says, “More than 60 percent of health workers’ uniforms sampled by researchers tested positive for pathogens, including germs that can cause pneumonia, bloodstream infections and drug-resistant infections such as MRSA.” The article went on to say, “Half of the samples tested positive for one or more pathogens; potentially dangerous bacteria were isolated from at least one site on 63 percent of the uniforms and 11 percent of those were bacteria that were resistant to multiple front-line antibiotics.” Since the early 1900’s, garments known as surgical scrubs have been worn by medical personnel in the operating rooms of hospitals. The term “scrub” comes from the practice of scrubbing ones hands before performing surgery or assisting in surgical procedures done by surgical personnel. In the late 1950’s, specially designed pant-like clothing, which was restricted at the feet and waist, made of specially woven material was introduced for women in the health care setting. The purpose then was to prevent the dissemination of skin bacteria from the surgeon or surgical personnel to the patient. However, this type of clothing is being used for many other situations in health care outside the operating room these days. In the late 1990’s, traditional scrubs, that you see worn around, were not made of any liquid-resistant, barrier-type material that would protect anyone from contaminates. It is postulated that unclean scrubs have the potential to spread bacteria to patients in hospitals and allow serious bacteria to escape into public places where you see people wearing them. Some hospitals currently prohibit wearing scrubs outside the building for fear of spreading infections of C.diff. which sicken thousands of people a year. The issue of infection revolves around the fact that some health care workers wear the same unlaundered uniforms to work 10 • Arizona Journal of Pharmacy • Winter 2014
day after day and start work already carrying bacteria such as staphylococcus, drug-resistant enterococcus and C.diff. Studies have shown that staph can live on polyester material for up to 60 days. In another example, C.diff., a common contaminant of many hospital surfaces, is very hard to control because it isn’t killed by most cleaners or laundry detergents and only using bleach solutions has proven effective in removing it. This is not the type of cleaning that usually occurs at bus stops, restaurants, or even pharmacy counters. According to the CDC, “If a patient has Hepatitis B, the virus can live in dried blood for up to a week” (Center of Disease and Prevention, 2010) and “If the patient has Hepatitis C, the virus can live up to 4 days in dried blood.” Data shows that more than likely, the bacteria detected on the clothing of medical staff can reflect poor hand-washing practices, a common problem at most hospitals, and studies have shown that between one-third and one-half of the health care workers fail to follow good hand hygiene. But, that being said, even though hand washing is an excellent practice of prevention, not all bacteria or organisms can be cleaned from just washing your hands. Scrubs can be splashed with medications or different body fluids. They can be wiped on, unintentionally brushed upon, and come into contact with numerous substances that contain harmful bacteria. A recent study showed that most health care workers wash their scrubs, in their homes, with their regular clothes, where the average washer temperature hovers around 120 to 125 degrees Fahrenheit, well below CDC recommendations of 160 degrees Fahrenheit for 3 minutes using bleach/water combinations. At the lower temperature, a possibility exists that the scrubs of these health care workers may not be sufficiently sterilized and allow the proliferation of C.diff., MRSA (Methicillin-resistant Staphylococcus aureus), normal bacteria, and fungi that normally live on or within our bodies. In the multitude of articles on this subject, evidence supported data always indicated that significantly higher bacteria counts were always found from home-laundered scrubs than from new, hospital-laundered and disposable scrubs. It’s important to remember that routine clothes washing is really a means of getting rid of general dirt and not bacteria (only about 80 percent). Did you know that laundries can get accredited? Yes, they can; by the Healthcare Laundry Accreditation Council (HLAC). They are the authority on laundry standards for the preparation of hygienically clean, reusable health care materials for patient care. They establish the standards for minimum acceptable practice for on-premise laundry (OPL), off-campus laundries known as commercial, retail facilities with customer-owned goods (COG), laundry facility-provided textiles, or in-house laundries operated by hospitals. But all is not lost. It may be time for rethinking policies that allow health care employees, in certain environments, to homelaunder scrubs and to pursue or research new, innovative products like ‘Vestex’, a fabric, which, in one study, showed favorable results by killing greater than 99.99 percent of resistant gram negative organisms tested against it. You may ask yourself, as a pharmacist or technician, ‘How does this relate to my practice setting?’ Currently, some regulations elude to cleanliness of clothing worn in specific environments as indicated in Arizona Administrative
Arizona State Board of Pharmacy (continued from page 10) Code (A.A.C.) R4-23-410( C)(2)(c )(i)(ii), ‘Current Good Compounding Practices’ it states that a pharmacist engaged in compounding “Ensures that personnel engaged in compounding wear clean clothing appropriate to the work performed and protective apparel, such as coats, aprons, gowns, gloves or masks to protect the personnel from chemical exposure and prevent pharmaceutical product contamination.” In A.A.C. R4-23-611(A) (6), ‘Pharmacy Facilities’ it states that a pharmacy permittee or pharmacist-in-charge shall ensure that “All professional personnel and staff of the pharmacy keep themselves and their apparel clean while in the pharmacy area.” And, lastly, in A.A.C. R4-23-671(E)(3)(F)(2), ‘Sterile Pharmaceutical Products’ for Standard-risk and Substantial-risk sterile pharmaceutical compounding, a pharmacy permittee or pharmacist-in-charge shall ensure compliance with the following minimum standards: “Each person who compounds wears adequate personnel protective clothing for sterile preparation that includes gowns, gloves, head cover, and booties.” Your current pharmacy practice setting may not be a hospital or in a post-operative out-patient setting, but there exists a potential that scrubs could be a source of contamination based upon the information written about the topic and numerous studies conducted. Bacteria have been found on scrubs, but keep in mind that other items also carry bacteria too, like ties, pens, and cell phones. The bottom line is that there is no scientific evidence or proof that the use of scrubs contributes to the cause or prevention of infections in health care settings. Because scrubs are so commonplace and replace traditional types of uniforms, their association with just surgical staff no longer prevails. The multitude of people wearing them raises an entirely new group of issues and challenges that need to be addressed by pharmacists and the entire health care team.
If you or someone you care about is suffering from an alcohol and/or chemical dependency problem... ...help is available.
Pharmacists Assisting Pharmacists of Arizona “A Partnership in Caring”
Contact Lisa Yates, PAPA Program Administrator at 928.532.2293 or papa@azpharmacy.org All calls confidential. Caller remains anonymous.
PAPA
is a program of the Arizona Pharmacy Foundation
PAAS Membership Benefits
• Expert Third-Party Audit Assistance • Monthly Third-Party Newsline • PAAS Member Manual & Third-Party Guide • PBM Resource/Advice & Contract Information • Valuable Forms & Reference Tools
Be Proactive. Be Protected. Be Prepared.
JOIN PAAS TODAY! 888.870.7227 | PAASnational.com Winter 2014 • Arizona Journal of Pharmacy • 11
Feature Pharmacist Expanding Patient Access to Pharmacists
by Marben Mopera, Pharm.D., Candidate, University of Arizona College of Pharmacy, Class of 2014 Lorri (Caum) Walmsley, a District Pharmacy Supervisor with Walgreens, is responsible for pharmacy operations at nearly 40 Walgreens pharmacies in the Phoenix south district. Her role includes ensuring that each pharmacy is compliant with state regulations. She also provides clinical direction as needed. Lorri graduated from The Ohio State University with a Bachelor of Science in Pharmacy in 2000 and then relocated to Arizona to begin her career as a pharmacist. How did you come to work with Walgreens? I began my career at Walgreens. I selected Walgreens because I knew that I’d have more opportunity to maximize my education and clinical knowledge. That was true when I began as a staff pharmacist and remains true today as opportunities for practical application of knowledge continue to evolve. What is your favorite part of working in your current position? This role provides me with an opportunity to practice at the top of my licensure and training. Pharmacy is playing an important role in health care and I am able to contribute to improved health outcomes. What are the sorts of challenges you face in your position? My role remains challenging when you consider how rapidly health care is evolving and the evolution of the traditional retail drugstore to a health care provider with pharmacy at its core. However, the challenges that I face are unique opportunities to continue building trusted relationships with customers and patients and help them make informed health choices. Where do you think pharmacy is going and where would you like to see it go? There are a number of health trends that are changing pharmacy. Patients want convenience, coordinated care, and affordability. Walgreens is transforming the way health care is delivered in the U.S. by offering unparalleled access to innovative, high quality, affordable health services in our communities through the pharmacy. With changes in health care legislation, I anticipate that Walgreens will continue to innovate and increase patient consultations.
Why do you think it is important for businesses and state organizations to work together? With all of the changes in health care legislation it is important that businesses align themselves with organizations with similar visions. A perfect example is Walgreens’ involvement with AzPA and the Arizona Retail Association to further the practice of pharmacy in the state by expanding scope of practice by allowing pharmacists to immunize without a prescription. Could you tell us about the changes in the Walgreens concept stores and what the goal is behind the changes? In order to truly make an impact on the health and well-being of the communities we serve, Walgreens has tailor-designed stores to meet health care needs by community. Our community pharmacies deliver a customer experience that creates greater access to pharmacists and more patient consultations and care. For example, Walgreens has invested in technology and care centers that enable pharmacists to have more time for face-to-face consultations. This model can help improve patient adherence and health outcomes which ultimately can lower health costs. What advice do you have for current students in pursuing a career like yours? Stay abreast of your industry by reading publications like Walgreens Student Pharmacist newsletter and getting involved in student organizations. What do you like to do in your free time? I currently serve as the Chair of the Arizona Community Pharmacy Committee with the Arizona Retail Association. I also am involved with AzPA and serve on the Legislative Affairs Committee. During my true free time I enjoy hiking and running.
Arizona Center for Professional Education
brought to you by the Arizona Pharmacy Association Lorri Walmsley, R.Ph., District Pharmacy Supervisor Phoenix South District Walgreens
12 • Arizona Journal of Pharmacy • Winter 2014
Your online source for continuing pharmacy education, skills enhancement, and professional development. Visit www.azpharmacy.org
Featured Article Perspectives from Within: Mock Interviews for Student Pharmacists at the AzPA Annual Convention by Suzanne Larson, Pharm.D., MWU CPG Associate Director of Experiential Education; Janet Cooley, Pharm.D., BCACP, UofA COP Director of Experiential Education; Lindsay Davis, Pharm.D., BCPS, Student Track Planning Committee Chair; Sikeat Yip, Pharm.D. Candidate, UofA COP Class of 2015; Amanda Powell, Pharm.D. Candidate, MWU CPG, Class of 2014; and Jeremy Hillman,Pharm.D. Candidate, MWU CPG, Class of 2015
As part of the 2013 AzPA Annual Convention this summer, student representatives serving from both colleges of pharmacy in Arizona came together on behalf of the AzPA Student Pharmacist Academy to organize a “Student Track” aimed at meeting the needs and interests of student pharmacists in Arizona. The student track consisted of seven sessions including student clinical pearls presentations, pharmacy expert roundtable sessions, joint academy meetings, the NASPA OTC Challenge, PharmOlympics competition, and the Casino Royale Social. As a result of the high-quality programming and enthusiasm surrounding the meeting, student registration and attendance achieved a record high with 154 students representing both colleges of pharmacy in Arizona present for the weekend-long meeting. In addition to the events listed previously, a mock interview and curriculum vitae (CV) review workshop took place during the Saturday meeting events. The intent of this session was to provide student pharmacists the opportunity to practice and receive critical feedback from practicing pharmacists regarding their interviewing skills and CV format/content. Students (interviewees) and pharmacists (interviewers) pre-registered for this event and were assigned an interviewing schedule that consisted of two to three 25 minute interviews for each student. In total, 54 students and 40 interviewers participated with every student participant completing a minimum of two interviews during the session. The feedback received from participants, both students and pharmacists, was overwhelmingly positive. Here are the perspectives from both the interviewer and interviewees, in their own words, regarding this experience and lessons learned. Interviewer Perspectives “The AzPA mock interview session was an inspiring, rewarding experience. At first, I was a little apprehensive, because it had been a few years since I’ve been actively involved in interviewing. Even though I felt unsure that I had any words of wisdom to impart to the participating pharmacy students, I decided to move forward.” “A few days prior to the event, the interviewers received preparation materials that included details about how the workshop would run, how to prepare, and some tips for conducting an effective interview. The event was well organized and the atmosphere was energizing. Eager, wide-eyed pharmacy students were signing in, and the interviewers seemed equally excited.” “I was able to interview three pharmacy students, representing both colleges of pharmacy. Never having met one of the students
before, we had a lot to talk about. He had just completed his first professional year and was eager for any feedback I could provide. I was impressed by his humility and his receptivity. It was a pleasure to work with him in this brief encounter. I was familiar with two of the students I interviewed, but I still learned surprising things about each student. For example, one student I knew very well informed me that a high-school accident left him temporarily paralyzed. We had a delightful conversation about how to use examples from life experience to demonstrate one’s core personality traits.” “At the conclusion of this session, I was thankful to have spent my Saturday morning helping these developing student pharmacists hone their interviewing skills. The aspect of precepting I find most rewarding is the feeling of being a part of someone’s journey. Taking part in the mock interview session allowed me to broaden my sphere of influence and make a small difference to a future colleague. I also value the education I receive as I am teaching. As I spent the morning teaching three students how to describe their leadership positions and reminding the students to incorporate personal examples in their stories, I myself was learning how to better communicate, provide feedback, and interview. I found truth in the Quaker Proverb, ‘Thee lift me and I’ll lift thee and we’ll ascend together.’ The competition for jobs and residencies has become fiercer and it is imperative that we work together to help committed pharmacy students achieve their highest level of success.” Interviewee Perspectives Why participate? “As a student preparing to enter the residency application process, I have made somewhat of a mental ‘toolbox’ over the last year filling it with the tools that I feel will be necessary to mold me into the strongest candidate I can be. So what are these tools, and why do I feel they have placed me in a competitive position amongst my peers? Well, there are many. A few of the most important for me have been obtaining a strong GPA and a sufficient understanding of what I learned in the didactic curriculum of pharmacy school, volunteering in the community, and the skills I continue to acquire every day as a student on clinical rotations. These tools have provided the foundation to set me up for success on rotations, interviews, post-graduate training, and my career thereafter. The tool that will arguably reap the most benefit when it comes down to the actual interview process? Practice. This is where mock interviewing comes into play.” “With more and more pharmacy schools opening up, the availability of job and residency positions is becoming increasingly competitive. Many students work diligently gaining experience, getting good grades, and being involved; however, these efforts can only lead to job/residency interviews. Many times the final decision on who is ultimately accepted for the job/residency comes down to the interview process, a concept that is terrifying for most students. After going through multiple interviews myself, whether for pharmacy school or employment, I am usually left wondering if I did well or not, which is an uneasy feeling that often never gets answered.” “The interview, in any context, is an intimidating and often challenging process to execute well. It is a critical step towards creating a solid professional relationship. Therefore, it is important for the interviewer to find the best candidate for each position. As an interviewee, having a great resume is not always Winter 2014 • Arizona Journal of Pharmacy • 13
Featured Article Mock Interviews ((continued from page 13) enough to promote oneself as the best candidate. Interviewing is a skill, and as such it gets easier with practice. The mock interview process can be a great way to get practice in the face-to-face interview environment. While I’ve experienced interviewing a number of times in my journey to become a pharmacist, my growth has been a result of self-reflection alone. During the mock interview session, the constructive feedback received regarding my skill set as an interviewee was both welcomed and powerful. Not getting the job could be an indicator that you could have done something better, but it is not an easy task to objectively assess your own performance.” Mock interview environment “The mock interviews gave me the opportunity to receive immediate feedback on my performance as an interviewee. This experience was beneficial on multiple levels. It offered a chance to meet and get advice directly from several practicing pharmacists from different areas of pharmacy. I was interviewed by a hospital pharmacy/residency director, an acute care hospital pharmacist, and a community pharmacist. Each pharmacist asked me common interview questions and provided me with direct input on my interviewing skills and curriculum vitae. They gave me feedback on my responses, mannerisms, and overall impressions. The casual nature of the event made it less stressful than most interview situations.” “Interviewers included a mix of residency coordinators, preceptors, managers of community pharmacies and others; all of whom had different personalities and expectations in a candidate. This allowed the student to get an experience much like they would in the real world. A student may have a casual interview session for one program/position and a very structured and formal session with the next. The variety, in my opinion, is important in the mock interview process in that it gives students the opportunity to react to different interview styles.” “The mock interview session was a stress-free, nothing-tolose opportunity to interview with pharmacy professionals from varying environments (academia, clinical, community, hospital, etc.). This allowed students a chance to freely express their answers, experiences, and opinions. Immediate feedback and constructive criticism provided by the interviewers can help students sharpen their skills, which is beneficial in that it exposes weaknesses, mannerisms, and negative tendencies that the students can improve upon. Likewise, positive feedback tells students what they are doing well and what their strong points are, encouraging them to take advantage of their strengths, and improve on their weaknesses. Furthermore, this experience allows students to become familiar with what kinds of questions an interviewer may ask, allowing students to better prepare and methodically think of strong points and experiences to emphasize. In addition to the mock interviews, students were also encouraged to submit a draft of their CV to which the interviewer can recommend any changes that may improve the draft. After being involved in setting up the mock interview sessions and observing the process, I feel more confident and comfortable with the interviewing process.” Value of participating “I found every aspect of both my sessions extremely beneficial, and I came out of the experience more prepared than when I 14 • Arizona Journal of Pharmacy • Winter 2014
entered. Constructive criticism was something that was hard for me to swallow at first, but ultimately has humbled me and given me the impetus to focus on identified areas for improvement. Additionally, having the interviewer congratulate me on areas in which they thought I excelled left me feeling optimistic about my future success.” “When it comes time for the ‘real thing’, I recognize that not a single thing I’ve done to prepare for the actual interview session will completely rid the anxiety I will have as I walk into the room for my first interview. With that said, I believe my performance will be much greater after having the invaluable experience of mock interviewing in my toolbox. I think this opportunity should be taken advantage of by all students regardless of their career path post-graduation, and I am incredibly grateful for all the interviewers who volunteered their time for these sessions.” “Though the conditions may be different from a real interview, this exposure will surely prepare a student for interviews as opposed to another student without this opportunity. Nerves will always be a factor in any real interview, but the experience of a mock interview gives students more confidence, an edge, and an increased chance of obtaining that job or residency they are seeking. Whether a student is insecure or confident about their interviewing skills, I highly recommend participating in a mock interview to further advance themselves in the competitive field of pharmacy.” “Overall I received great advice on how to improve on paper and in person. I also caught a glimpse of what traits interviewers look for in their candidates. The experience definitely boosted my confidence in my interviewing skills and helped me focus my approach for future interviews. I would recommend participating in a mock interview workshop to anyone as its invaluable experience is difficult to get elsewhere.” Future Plans Based on the interest level and feedback received, the AzPA Student Academy Annual Convention Student Track Planning Committee plans to have this session be a recurring event for years to come. Thank you to everyone who has participated in this endeavor. We encourage those interested in advancing their skill set as an interviewee or an interviewer to consider participation in future years. Together we can accomplish our goals and mentor one another in our professional advancement.
BUYING TEXTBOOKS ONLINE? SUPPORT AzPA! Access amazon.com through the AzPA home page and then bookmark the link. Each time you make a purchase on amazon.com a portion of your purchase price will be donated to AzPA.
Featured Article Developing, Expanding, and Improving Pharmacy Residency Programs in Arizona: Symposium and Workshop
by Philip J. Schneider, MS, FASHP, Professor and Associate Dean at the University of Arizona College of Pharmacy and Lindsay Davis, Pharm.D., BCPS, Assistant Professor, Midwestern University College of Pharmacy-Glendale Thirty Arizona pharmacists gathered at the new Health Sciences Education Building on the Phoenix Biomedical Campus on October 18, 2013 for a day-long symposium and workshop about pharmacy residency programs. This program was co-sponsored by The University of Arizona and Midwestern University-Glendale Colleges of Pharmacy and the Arizona Pharmacy Association. The co-chairs of the program were Lindsay E. Davis, Pharm.D., BCPS, Assistant Professor at Midwestern University-Glendale and Philip J. Schneider, MS, FASHP, Professor and Associate Dean at the University of Arizona. The goals of this program were to evaluate the need for and requirements of pharmacy residency training programs, justify the need for and value of these programs, describe the costs of a pharmacy residency programs and the cost offset resulting from the residents, and to discuss the development and expansion of pharmacy residency programs in Arizona. Leading off the symposium was an overview of pharmacy residency training in Arizona by Dr. Davis. In her presentation the importance of residency training to improve pharmacy practice and implementation of the ASHP Pharmacy Practice Model Initiative was stressed. The need for and value of residency training in the Arizona pharmacist job market was explained. The unmet demand for pharmacy residency positions among the graduates of the two colleges of pharmacy in Arizona was highlighted. The second presentation by Mary Manning, Pharm.D., Director of Pharmacy at Scottsdale Healthcare - Shea described how to develop a pharmacy residency program. The role of the Residency Program Director was described and the qualifications needed to be a residency preceptor were listed. The utility of the ASHP Residency Learning System and Residency Matching Program were reviewed.
Two faculty from The University of Arizona College of Pharmacy, Brian Erstad, Pharm.D., Professor and Head, Department of Pharmacy Practice and Science and Professor Schneider moderated two interactive sessions on the requirements of residency training programs and justification of these programs. Special attention was focused on the Medicare passthrough program as a method for recovering some of the costs of a pharmacy residency program. After lunch sponsored by the Arizona Pharmacy Foundation, registrants chose roundtable workshops to explore developing and expanding residencies in the following settings: Hospital and health-systems, ambulatory, clinic-based pharmacy, and community, retail-based pharmacies. Out of these workshops, the following initiatives were suggested to create momentum for creating and expanding residency training programs in Arizona: • Providing a forum within AzPA to continue and facilitate communication among those involved with and interested in residency training • Surveying those who participated about ways to promote pharmacy residency training in Arizona • Creating a roadmap and providing tools to qualify pharmacists to serve as residency preceptors • Develop programming at AzPA meetings on subjects related to residency training programs
Arizona Pharmacy Association presents Arizona Pharmacy Law and Public Policy Course COMPLETELY REVISED! The ideal preparation for the MPJE! Available on-demand at the Arizona Center for Professional Education website. Registration is available online only at: www.azpharmacy.org/ Pharmacy_Law Full Course - 9.0 hours continuing pharmacy education (0.90 CEUs) AzPA Member: $200 Non-Member: $300 Student*: $100 *Not eligible for continuing pharmacy education credit.
Companion textbook available for purchase at www.azpharmacy.org/Law_Textbook
Brian Erstad, Pharm.D., presented requirements for residency training programs. Winter 2014 • Arizona Journal of Pharmacy • 15
Featured Article Let it Snow! by Joe Rowan, R.Ph.
In December 1967, Flagstaff was bombarded with eight feet of snow in a one week period. Needless to say, we were rather boxed in with heavy drifts of snow. All the cars were socked in, so for two days we walked to and from the pharmacy. It was only about two miles, but the snow was deep. Snow was piled high on the streets and on the roofs of the buildings. One night my wife Mims was on our roof at home shoveling off the snow. She noticed some of our young children observing her efforts. She scolded them for being up on the roof of the house. They replied that they were not on the roof but standing on a snow bank up against the house! Many workers were stranded in downtown Flagstaff and were holing up in the local hotels. Our soda fountain became one of the places that many of these displaced individuals took their meals. We served so many sandwiches that we were running short on supplies. Mims called the route man and asked if he could deliver more stock. He lived in a mobile home park nearby and said he would be glad to make a delivery, but he could not get his truck out of the snow. We had finally freed our Volkswagen Bug from the snow bank and Mims volunteered to come out to his place if he could provide the needed stock replacement. When she arrived at his home, he again apologized for not being able to deliver due to his truck being buried in the snow. Mims inquired as to where his truck might be and his reply was, “You are standing on it.” Sure enough, she could see the roof of his delivery van under her feet. While the city started to plow out from under all the snow, we delivered to our customers in our Volkswagen as best we could. That little Bug got around very well with no chains or snow tires. Mims was delivering some medications to one of our regular customers and when she arrived at the home, she
had to take a shovel out of the Bug and make a path up to the front door. This took some doing as no snow had yet been cleared. When she reached the front door, she was greeted by the customer’s 16-year-old son who was the picture of health and vitality. His remark to Mims was that he and his mother had watched her endeavors in shoveling and sincerely hoped she would be successful. No thanks for clearing the path for them, as well as no effort to assist. But then, that’s all part of the life in the drugstore. The snow finally melted away, although it took until June for the many mountains of slush and ice that had been created from plowing the streets to completely disappear. There were no further snow storms that winter. This is the twelfth installment in a series of reflections from Joe Rowan, R.Ph., longtime Arizona pharmacist, and AzPA member. Follow Joe’s memoirs in future issues of the Arizona Journal of Pharmacy or catch up on past installments by visiting the Arizona Journal of Pharmacy archives on the AzPA website.
“I’M ALWAYS WATCHING OUT FOR MY PATIENTS, BUT WHO’S WATCHING OUT FOR ME?”
WE ARE. We are the Alliance for Patient Medication Safety (APMS), a federally listed Patient Safety Organization. Our Pharmacy Quality Commitment (PQC) program helps you implement and maintain a continuous quality improvement program that offers strong federal protection for your patient safety data and your quality improvement work. PQC also helps you comply with quality assurance requirements found in network contracts, Medicare Part D, and state regulations. We offer flexible and powerful tools, ongoing training and support to keep your pharmacy running efficiently, and most importantly, to keep your patients safe.
Call toll free (866) 365-7472 or visit www.pqc.net PQC IS BROUGHT TO YOU BY YOUR STATE PHARMACY ASSOCIATION
16 • Arizona Journal of Pharmacy • Winter 2014
Featured Article
A Look Back - Botanical Print by Robert E. Kravetz, MD, FACP, MACG American College of Gastroenterology
The art of botanical illustration has its origin over 2000 years ago, going back to Egyptian, Greek, and Roman times. Illustrations were compiled in herbal compendiums. The essence of an herbal was a combination of plant lore, botanical classification, and the medicinal properties of each herb. Botanical artists were commissioned to illustrate herbs that were grown in gardens for their beauty, as well as plants that were used for medicinal purposes, because that was all that was available before the scientific advances in therapeutics during the 20th century. In Europe, wealthy patrons collected vast numbers of botanical prints and were very supportive of the artists. During the 20th century, many major pharmaceutical companies, some of which are still in existence today, had formularies that consisted almost entirely of herbal preparations. It is important to recall that plants have been a significant source of many important drugs and the rainforests are still searched today for promising new therapeutic agents. Botanical illustrations are a precious legacy that permits us to appreciate the skill of the artists and the beauty of the plants while recognizing the role both have played in the history of medicine. The fresh leaves and branches of Atropa belladonna, deadly nightshade, are illustrated in this plate from a Manual of Vegetable Materia Medica dated 1877.
Pharmacy Time Capsules First Quarter 2014 1989: Twenty-five Years ago: •
The second Pharmacy in the 21st Century (P21) conference held in Williamsburg. The concept of pharmaceutical care was formally introduced by Hepler and Strand and enthusiastically accepted.
1964: Fifty Years ago: • The survey, Mirror to Hospital Pharmacy, published. Data included that less than 40% of all hospitals employed approximately 2,000 full-time pharmacists 1939: Seventy-five Years ago: • Western Massachusetts School of Pharmacy opened in Willimansett, MA although never accredited
1914: One hundred Years ago • The federal Harrison Narcotic Act passed to regulate and tax the importation, production, and distribution of narcotics. 1889: One hundred twenty-five Years ago: • Walden University (Meharry Pharmaceutical College) opened in Nashville
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.
Winter 2014 • Arizona Journal of Pharmacy • 17
Featured Article Ketorolac: The Best Analgesic for Your Grandmother?
by Alexandra Trinh, Pharm.D. Candidate, Midwestern University College of Pharmacy-Glendale, Class of 2014/AzPA Student Pharmacy Academy Member; Melinda (Throm) Burnworth, Pharm.D., BCPS, Midwestern University College of Pharmacy-Glendale/AzPA Health System Academy Member PATIENT CASE: NBT, a 90 kg, 95-yearold grandmother of 11, presents to the hospital with complaints of painful, tingling, stabbing like pain on the bottom of her feet. She reports having varicella zoster as a child and having one kidney removed. Her past medical history and surgical history include varicella zoster, left nephrectomy, gastrointestinal bleeding ulcer, and gout. She denies medication allergies. Her admission labs include: BUN/Cr 20/1.3, H/H 14/45. On day three of admission, despite titration of intravenous morphine, NBT still complains of pain 10/10 (on a 10-point scale, 0=no pain, 10=worst pain). She is diagnosed with a severe case of shingles on right torso and right lower extremity. To gain better pain control, NBT is prescribed ketorolac (Torodol) 30 mg intravenously every six hours (no stop date). After two doses of ketorolac, she is noted to be guaiac positive. Day 3 labs include: BUN/Cr 30/2.1, H/H 9/30. Was ketorolac the best analgesic for this grandmother? Is it the best analgesic for your grandmother? To answer this, a short review of ketorolac and its clinical application are necessary. USES: Ketorolac is a non-steroidal anti-inflammatory drug (NSAID) that was FDA approved in 1989 for short-term management of pain.1 It is typically used for moderate to severe pain and visceral pain associated with cancer and has also been found to be particularly useful in treating pain due to bone metastases.2 STABILITY: Ketorolac should be protected from light as prolonged exposure may discolor the solution and promote precipitation. The injection should be stored at 15-30 degrees Celcius. When it is stored at the correct temperature, 0.6 mg/ml is compatible with normal saline, 5% dextrose in water, normal saline plus
5% dextrose in water, and Ringer’s and Lactated Ringer’s solution for at least 48 hours.2 Ketorolac 15 mg/ml should not be mixed or administered in the same syringe with the following: opiate agonists, promethazine, or hydroxyzine. The admixtures have a relatively low pH which can cause precipitation.2 CHEMISTRY: Ketorolac is a pyrrolizine carboxylic acid and cyclic propionic acid derivative.2 Ketorolac has high water solubility due to the tromethamine salt and high potency, making it suitable for parenteral use.1 The pKa of ketorolac in water is 3.54.2 The S (-) enantiomer is more biologically active than the R (+). The injection is a sterile solution of drug in alcohol and water and is clear and slightly yellow in appearance. HCl or NaOH or both may be added during manufacture to adjust the pH to 6.9-7.9.2 MECHANISM OF ACTION: Ketorolac is an analgesic with antiinflammatory and antipyretic activity.1 The analgesic effect is greater than the anti-inflammatory effect. It works by inhibiting prostaglandin synthesis through blockade of the cyclooxygenase pathway of arachidonic acid metabolism.1 Unlike opioids, which have encephalin activity, ketorolac’s analgesic action is not related to encephalin activity.1 Ketorolac reversibly inhibits platelet aggregation.2 Due to this effect, ketorolac may prolong bleeding time. With a regimen of ketorolac 30 mg intramuscularly QID x 5 days, the mean bleeding time was prolonged from 4.9 minutes to 7.8 minutes.3 The effect on platelet function was found to be transient and aggregation returned to normal within 24-48 hours after administration was discontinued. Ketorolac has no effect on platelet count, prothrombin time or partial thromboplastin time.1 PHARMACOKINETICS: Ketorolac is completely absorbed intramuscularly and reaches peak plasma concentration in approximately 1 hour.1 With oral administration, there is 80-100% bioavailability.2 Food decreases the rate but not the extent of oral absorption.2 The plasma half-life is 4-6 hours in normal adults but can be prolonged in elderly patients (4.7-8.6 hours) and in patients with renal impairment (3.2-15.7 hours).1 Steady state can be achieved and
18 • Arizona Journal of Pharmacy • Winter 2014
maintained by administering a dose every 6 hours. Ketorolac is strongly bound to protein (99%) and 90% is excreted through the kidneys.1 It distributes primarily to vascular and extracellular compartments. High doses of salicylates can displace ketorolac and increase the likelihood of toxicity.1 Pain relief may occur within 10 minutes of injection but peak analgesic effects do not occur until 1 1/4 to 2 hours after administration.1 A loading dose of twice the maintenance dose is recommended to prevent delay in pain relief. Ketorolac follows linear pharmacokinetics with a 2 compartment model with first order absorption and elimination.1 At physiological pH, the drug is present in dissociated form as ketorolac (anion) and tromethamine (cation). Volume of distribution at steady state is 0.11-0.33 L/kg. This drug does not cross the blood brain barrier well but can cross the placenta and distribute small amounts into milk.2 Ketorolac declines in a biphasic manner with a terminal elimination half-life of 4-6 hours. In patients with renal impairment, elimination half-life is prolonged to 9-10 hours.2 ANALGESIC EFFICACY: Ketorolac has been shown to be as effective as equivalent analgesic doses of morphine or meperidine and is longer lasting.1 Unlike morphine, it has few central nervous system actions. Because ketorolac has opioid sparing effects when used in combination with morphine, less morphine may be required which makes it useful in patients with a history of opiate dependency.1 Ketorolac can be combined with opiate analgesia to achieve a sparing effect. Combined therapy results in a 25-50% reduction in opioid requirements, more rapid return to normal GI function and a shorter length of stay.4 Ketorolac is more potent than aspirin, indomethacin and naproxen. It has 500-800 times the analgesic potency of aspirin and does not result in physical dependence.2 METABOLISM: Ketorolac undergoes hydroxylation, conjugation with glucuronic acid and is renally excreted by the kidneys.2 50-60% is excreted in urine as ketorolac, 20-26% as ketorolac glucuronide, 11-12% as p-hydroxyketorolac and 6-7% as polar metabolites.2 Total plasma clearance is decreased in patients with reduced renal
Featured Article Ketorolac (continued from page 18) function and elderly patients.2 ADVERSE REACTIONS: Adverse reactions include somnolence, nausea, edema, abdominal pain, diarrhea, dizziness, sweating and pain at the injection site. Pain at the injection site can be minimized by applying pressure over the injection site for 15-30 seconds after administration.2 Unlike opioids, ketorolac is not related with respiratory depression and is a good choice for patients with chronic obstructive pulmonary disease or other respiratory problems.1 Because ketorolac is excreted in breast milk, although in small amounts, it should be avoided in pregnancy and lactation.1 Ketorolac can slightly elevate liver function tests. It should not be used in obstetric analgesia due to prostaglandin synthesis inhibition which could affect uterine contractility and decrease fetal circulation.1 Ketorolac adversely affects renal function which may manifest as acute kidney injury, analgesic nephropathy, acute interstitial nephritis or serious fluid and electrolyte disorders.4 Renal toxicity is associated with increasing levels of serum creatinine (Cr), blood urea nitrogen (BUN) and potassium and decreased urine output. Ketorolac inhibits prostaglandins (E series, prostacyclin) that exhibit protective effects on the gastric mucosa. Inhibition of the prostaglandins can damage the gastric mucosa resulting in ulceration and bleeding.2 The risk of bleeding is strongly linked to increasing age, high doses and treatment for more than 5 days. Ketorolac does not exhibit any psychomotor or hemodynamic effects.3 DRUG INTERACTIONS: Ketorolac interacts with other NSAIDs, salicylates, warfarin, diuretics, lithium and methotrexate.1 Use of ketorolac with diuretics increases the risk of developing renal failure secondary to decreased renal blood flow.1 It can also decrease the renal clearance of lithium which can result in an increased risk of lithium toxicity.2 Ketorolac can elevate and prolong blood concentrations of methotrexate due to inhibition of renal elimination of methotrexate.2 Extra caution should be taken with patients who have cardiac decompensation, hypertension or other conditions associated with fluid retention.2
DOSAGE & ADMINISTRATION: Oral administration of ketorolac is indicated only as continuation therapy after parenteral administration and maximum duration of therapy (for parental and oral) is 5 days due to increased risk of bleeding.4 Ketorolac is contraindicated in patients with congestive heart failure, hepatic impairment, hypertension or conditions that may lead to a reduction in blood volume. It is also contraindicated in patients who are hypersensitive to aspirin or other NSAIDs.4 The intramuscular dose is 60 mg as a single dose or 30 mg every 6 hours with a maximum dose of 120 mg daily. The intravenous (IV) dose is 30 mg as a single dose or 30 mg every 6 hours with a maximum dose of 120 mg daily. The oral dose is 20 mg followed by 10 mg every 4-6 hours as needed with a maximum dose of 40 mg daily.5 In patients greater than 65 years, weight less than 50 kg, or with renal insufficiency, the maximum daily dose of IV ketorolac is 60 mg daily; the maximum daily dose of oral ketorolac is 20 mg daily.5 COST5: Solution (Ketorolac Tromethamine Injection) • 15 mg/mL (1 mL): $2.08 • 30 mg/mL (1 mL): $0.84 • 60 mg/2 mL (2 mL): $1.92 • 300 mg/10 mL (10 mL): $10.14 Solution (Ketorolac Tromethamine Intramuscular) • 30 mg/mL (1 mL): $2.08 • 60 mg/2 mL (2 mL): $0.84 • Tablets (Ketorolac Tromethamine Oral) • 10 mg (100): $102.50
Left to right: Grandson Billy Throm, Grandmother Nellie Belle Throm, Granddaughter Melinda (Throm) Burnworth
GRANDMOTHER’S TOP 5 KETOROLAC PEARLS AND CLINICAL RELEVANCE: 1. Ketorolac should only be used for a maximum duration of 5 days due to the increased risk of bleeding. If not already in place, health-systems should consider implemention of a 5 day auto stop to ensure that the patient does not exceed the maximum duration of therapy. 2. Clinicians and pharmacists should verify the patient’s age, weight and renal function before initiation of or dispensing ketorolac to prevent an adverse event or sentinel event. Health-systems should consider creation of a decision algorithm to assist clinicians with appropriate prescribing and dispensing of ketorolac. 3. Ketorolac is contraindicated in patients with congestive heart failure, hepatic impairment, hypertension or history of gastrointestinal (GI) bleed. Health-systems should consider creation of a decision algorithm to assist clinicians with appropriate prescribing of ketorolac. 4. The dose difference between oral and intravenous ketorolac is quite unusual. As absorption is complete with IV administration, typically the IV dose is much lower than the oral dose for most medications. However, in the case of ketorolac, the oral dose of ketorolac is lower. All NSAIDs, including ketorolac, are considered inorganic acids. Because the gastrointestinal tract is already acidic, the acidic nature of ketorolac is more
Grandmother Tiet Truong and Granddaughter Alexandra Trinh
Winter 2014 • Arizona Journal of Pharmacy • 19
Featured Article Ketorolac (continued from page 19) likely to irritate the GI mucosa and increase the risk of bleeding. 5. Ketorolac has drug-drug interactions with aspirin and other NSAIDs along with a few other drugs. It is important for clinicians and pharmacists to screen medication profiles for these interactions that may lead to an unfortunate event. Grandmother NBT was a school teacher for over 50 years and has shared her lessons with students of all ages. Posthumously, she continues to share her pearls of wisdom. Ketorolac was not the best analgesic for Grandma Nellie Belle Throm. Alexandra Trinh, Pharm.D. Candidate discovered that ketorolac would not be the ideal analgesic for her grandmother, Tiet Truong, either. Is it the best analgesic for your grandmother? Based on “Grandmother’s Top 5 Ketorolac Pearls” this potent NSAID may not be the ideal analgesic for elderly patients based on age, renal function, and bleeding risk. In memory: Nellie Belle Throm (October 25, 1908-February 21, 2007) Acknowledgments: Maricopa Integrated Health System Library: Deborah Richards, Library Assistant and April Aguinaga, MLS, AHIP References 1. Dipalma, JR. Ketorolac: An Injectable NSAID. Am Fam Physician. 1991 Jan;43(1):207-10. 2. Litvak KM, McEvoy GK. Ketorolac, an injectable nonnarcotic analgesic. Clin Pharm 1990 Dec;9(12):921-35. 3. Buckley MM, Brogden RN. Ketorolac. A review of its Pharmacodynamic and Pharmacokinetic Properties, and Therapeutic Potential. Drugs. 1990 Jan;39;(1):86-109. 4. Gillis JC, Brogden RN. Ketorolac. A reappraisal of its pharmacodynamics and pharmacokinetic properties and therapeutic use in pain management. Drugs. 1997. Jan;53(1):139-88. 5. Ketorolac. In: Lexi-Drugs Online. Hudson, OH:Lexicomp Inc. Updated 2013 July 22.
The Use of Tranexamic Acid in Orthopedic Surgery
by Cassandra Ehrlich, Pharm.D. PGY1 Pharmacy Practice Resident Christi Jen, Pharm.D., BCPS Clinical Pharmacist, Emergency Medicine, Banner Boswell Medical Center Postoperative anemia and bleeding, necessitating allogeneic blood transfusions, are two major concerns for patients undergoing total hip and knee arthroplasties. Although effective, allogeneic blood transfusions do not come without risks and limitations. Limited blood supply and transfusion complications, such as hemolytic reactions, febrile reactions, clotting abnormalities or transmission of infection,1 have created a need for novel strategies to prevent and manage postoperative blood loss. Strategies such as manual compression, autologous blood salvaging procedures and pharmacologic intervention2 are being used more frequently. Tranexamic acid is a pharmacologic agent that is being used more commonly in order to manage and prevent postoperative blood loss. In order to understand the mechanism of tranexamic acid and its role in orthopedic surgery, it is important to understand the process of hemostasis. When a blood vessel is damaged, whether by trauma or surgery, and a hemorrhage occurs, the body begins the process of hemostasis, or the arrest of bleeding.3 Hemostasis begins with initial vasoconstriction of the injured vessel and is followed by three phases.3 First a loose platelet plug is formed when platelets bind to exposed collagen at the site of injury causing platelets to release thromboxane A2 and adenosine diphosphate (ADP), which leads to further platelet aggregation and the formation of a hemostatic plug.3 Next, through activation of the clotting cascade, thrombin cleaves fibrinogen to fibrin, allowing fibrin to aggregate and form a more stable, insoluble fibrin clot.3 Finally, the process ends when the fibrin clot is dissolved by plasmin.3 Fibrinolysis is the process by which fibrin deposits and unnecessary fibrin clots are dissolved by plasmin.13 Plasmin circulates in its inactive form known as plasminogen. In order for plasminogen to carry out its proteolytic effect, it must first be converted to plasmin by tissue
20 • Arizona Journal of Pharmacy • Winter 2014
plasminogen activator (t-PA).3 Tissue plasminogen activator is released in response to endothelial damage, such as surgery, and converts plasminogen to plasmin in the presence of fibrin.13 Of note, at physiologic levels, plasmin has specificity for fibrin clots, due to its specialized protein domains (kringles) where it binds with exposed lysine residues on fibrin clot.5 At pharmacologic levels, this clot specificity is lost, resulting in a systemic lytic state, which significantly increases the risk of bleeds.5 Synthetic tissue plasminogen activators have been used medically to increase fibrinolysis in conditions such as ischemic stroke, where increased fibrinolytic activity dissolves thrombi, restoring blood flow to ischemic areas. Decreased fibrinolysis reduces the risk of bleeding that is caused by excess clot lysis, which is useful in surgery, where t-PA is released in response to the tissue damage resulting in a hyper-fibrinolytic state.4 The agents aminocaproic acid, tranexamic acid and aprotinin are inhibitors of fibrinolysis that have been used clinically to reduce incidences of operative bleeding.5 In 2007, Bayer Pharmaceuticals Inc suspended marketing of Trasylol® (aprotinin) when it was found to have an increased risk of long-term mortality.9 Aminocaproic acid and tranexamic acid are the only pharmacologic options available to decrease fibrinolysis and reduce bleeding. Tranexamic acid exhibits its antifibrinolytic effect by forming a reversible complex with plasminogen and plasmin.6 Tranexamic acid, a synthetic lysine analog, competitively inhibits the activation of plasminogen to plasmin. When lysine binding sites are saturated with tranexamic acid, plasminogen is no longer able to bind with fibrin, thus inhibiting fibrinolysis.6 Although some plasmin is still activated when bound to tranexamic acid, it cannot bind to fibrin to exert its fibrinolytic effect. Tranexamic acid has been compared to aminocaproic acid, another synthetic lysine analog. Although they share the same mechanism of action, tranexamic acid has been shown to be 6 to 10 times more potent than aminocaproic acid.6 Tranexamic acid does not have an FDA labeled indication for use in orthopedic surgery. Intravenous tranexamic acid is indicated for short-term use, 2-8 days, in patients with hemophilia in order to reduce
Featured Article Tranexamic Acid (continued from page 20) or prevent hemorrhage in patients who are undergoing tooth extraction.7 The oral formulation is indicated for the treatment of cyclic heavy menstrual bleeding.8 While these are the only approved on-label use for tranexamic acid, it has been used for many off-label purposes. Tranexamic acid has been used to prevent bleeding and reduce the need for blood transfusions in cardiac surgeries, acute upper gastrointestinal bleeding, spinal surgeries, transurethral prostatectomy, cesarean deliveries, and total hip and knee arthroplasties.8,9 The efficacy of tranexamic acid in reducing the risk of death from bleeding in trauma patients was assessed in the Clinical Randomisation of Antifibrinolytic in Significant Haemorrhage 2 (CRASH-2) trial. The CRASH-2 trial was a randomized, placebo controlled trial that assessed the effects of early administration of tranexamic acid on death, vascular occlusive events, and on the receipt of blood transfusions.4 After meeting eligibility criteria, 20,211 patients were randomly assigned to either tranexamic acid or placebo. Patients either received a loading dose of 1 gram of tranexamic acid infused over 10 minutes, followed by 1 gram intravenous infusion over 8 hours or a matching placebo.4 Death from bleeding was reduced in the tranexamic acid group (RR = 0.85; 95% CI 0.76-0.96. p=0.0077).4 This study showed the benefit of tranexamic acid in reducing mortality from bleeding in trauma patients. The CRASH-2 trial demonstrated a benefit in reducing deaths from bleeding in trauma patients, whereas tranexamic acid’s utility in reducing blood transfusion and total blood loss during orthopedic surgery was studied by Gandhi et al. Gandhi and colleagues performed a meta-analysis, published in 2013, of randomized controlled trials assessing the efficacy of tranexamic acid in patients who underwent unilateral total knee arthroplasty (TKA) or total hip arthroplasty (THA) for the outcomes of total blood loss, the number of patients needing allogeneic transfusions, and the incidences of developing thromboembolic conditions. Studies were included in the meta-analysis if: patients underwent primary unilateral TKA or THA; the study compared tranexamic acid to a control group; outcomes included total blood loss, number of patients receiving allogeneic
blood transfusion and/or incidence of thromboembolic complications; was a randomized controlled trial; was published or unpublished from 1995 to July 2012. Thirty-three studies were included in the meta-analysis. For total blood loss, the combined weighted mean difference (WMD) for patients undergoing TKA was reported to be -1.149 (p<0.001, 95% CI -1.298 , -1.000), which indicated that for TKA patients, blood loss was statistically significantly less in the patients receiving tranexamic acid versus the control group. In the THA, the WMD for total blood loss was -0.504 (p<0.001; 95% CI, -0.672, -0.336), again showing significantly less bleeding in the tranexamic group versus control. Combined odds ratio for the number of patients requiring blood transfusions for TKA was 0.145 (p<0.0001; 95% CI, 0.094, 0.223) and THA was 0.327 (p<0.001; CI, 0.208, 0.515) indicating that the number of patients requiring blood transfusions were less in the tranexamic acid groups when compared to the control groups. Lastly the combined odds ratio for number of patients who developed a deep vein thrombosis (DVT) for those undergoing TKA was 1.030 (p=0.946; 95% CI, 0.439, 2.420), and for patients undergoing THA was 1.070 (p=0.895; 95% CI. 0.393, 2.911); thus the literature indicates that for TKA and THA there was no increase in incidence of developing DVT in the tranexamic acid group when compared to the control groups. This study suggests that administering tranexamic acid during THA and TKA significantly reduces the amount of total blood lost and number of patients requiring blood transfusions without increasing the Indication TKA
THA Contraindications:
Dose 10 mg/kg
likelihood of developing thromboembolic complications. In addition to a decrease in total blood loss, and blood transfusions, tranexamic acid may offer cost reductions. The cost of one gram of intravenous tranexamic acid solution is $79.20,9 compared to the cost to acquire one unit of packed red blood cells, which is approximately $211.00.10 Irisson et al. conducted a study and noted a cost reduction with the use of tranexamic acid in orthopedic surgery. The authors conducted a single-center, retrospective study comparing two groups of consecutive patients undergoing THA or TKA by a single surgeon. The first group, which were surgeries performed from January 2007 to October 2008, received no tranexamic acid. The second group, from November 2008 to December 2009, received tranexamic acid perioperatively. Included in the study were 451 patients, of which 210 received tranexamic acid, while 241 patients did not. In the tranexamic acid group, tranexamic acid was given as a 30 minute intravenous infusion: one gram before the incision, one gram at wound closure, and one gram every 6 hours for the following 24 hours. Total blood loss was 1900 mL ±690 mL in the non-tranexamic acid group and 1260 mL ±620 mL in the tranexamic acid group (p <0.001). Moreover, 10 patients in the non-tranexamic group received allogeneic blood transfusion, while there were none in the tranexamic acid group (p<0.001). The total cost of blood transfusions was 38,870 Euros ($52,564) in the nontranexamic acid group compared to 22,800 Euros ($30,832) in the tranexamic acid group. This represents a cost savings of approximately 25%. This study not
Timing 15 minutes 3 hours after before tourniquet tourniquet deflation deflation 10 mg/kg 20 minutes before 3- 6 hours after incision 1st dose Hypersensitivity to tranexamic acid, active thromboembolic disease, history of thrombosis or thromboembolism, intrinsic risk of thrombosis (eg, hypercoagulopathy, thrombogenic cardiac rhythm disease), subarachnoid hemorrhage, color vision defects 20 minutes before tourniquet inflation
Renal Dosing: Serum Creatinine
1.36-2.38 mg/dl
2.38-5.66 mg/dl
>5.66 mg/dl
10 mg/kg No more than 2 doses
10 mg/kg daily
5 mg/kg every 24 daily
Arizona Journal of Pharmacy • Winter 2014 • 21
Featured Article Tranexamic Acid (continued from page 21) only demonstrated a reduction in blood loss during orthopedic surgery, but found that tranexamic acid reduced costs by decreasing the amount of transfusions needed. Tranexamic acid is available in two formulations: solution for intravenous administration, Cyklokapron®, and tablets for oral administration, Lysteda®. Both products are available generically. The solution can be mixed with most diluents, such as dextrose or normal saline.7 The mixture should not be added to blood products or mixed with solutions containing penicillin.7 Once prepared, the solution should be used the same day.7 Doses are usually diluted to 50-250 mL and administered over 5-30 minutes with a maximum rate of 100 mg/minute.9 For orthopedic surgery, dosing strategies have varied widely from study to study and no consensuses on optimal dosing regimens have been reached. Studies have established that intravenous doses of 10 mg/kg are needed in order to reach a therapeutic concentration that will adequately reduce plasminogen.14 Doses of 10 mg/kg will maintain therapeutic concentrations of 10 ng/ml for approximately 3 hours.14 Fibrinolysis begins with surgical trauma and is enhanced by the use of a pneumatic tourniquet, an effect which continues into the post-operative period.14 Because of this prolonged fibrinolytic activity, a second dose of 10 mg/kg dose can be given 3 hours after the first dose, or immediately after the tourniquet is released.9 The optimal dosing regimen for total knee arthroplasty was studied by Maniar et al. who showed that a regimen consisting of a pre-operative dose given 20 minutes before tourniquet application, a intraoperative dose given 15 minutes before tourniquet deflation, and a post-operative dose given 3 hours after the intraoperative dose was the most effective regimen resulting in the least amount of total blood loss.14 For total hip arthroplasty 10 mg/kg is given 5 -15 minutes before incision and may be followed by subsequent 10 mg/ kg doses.11 No maximum doses have been reported in the literature for use in TKA or THA. Doses of up to 100mg/ kg have been used in spinal surgery.9 Over 95% of tranexamic acid is excreted unchanged in the urine by glomerular filtration.8 Dosage adjustments are needed
in renal dysfunction. The Cyklokapron® manufacturer recommends decreasing dosing frequencies at serum creatinine levels greater than 1.36 mg/dL.7 Reported adverse events are uncommon with tranexamic acid therapy. The most commonly reported effects include nausea, diarrhea, and orthostatic reactions.6 Based on its mechanism of action, tranexamic acid theoretically increases the risk of thrombosis. However, there have only been isolated case reports of thrombosis, and the results of randomized clinical trials do not show a statistically significant association between tranexamic use and an increased risk of developing thromboembolic conditions.6 The CRASH-2 trial showed no statistically significant difference in death by vascular occlusion in the tranexamic acid group compared to the placebo group (RR 0.69, 95% CI 0.44, 1.07; p = 0.096).4 Although trials have failed to show an increased risk of developing thromboembolic disease with the use of tranexamic acid, patients with active thromboembolic disease, a history of thrombosis or thromboembolism, or an intrinsic risk of thrombosis or thromboembolism should not use tranexamic acid.8 Patients with subarachnoid hemorrhage should not use the injectable formulation, as it may lead to cerebral edema and cerebral infarction.7 Patients with acquired defective color vision should not use tranexamic acid since it interferes with monitoring endpoints. Tranexamic acid administration has caused areas of retinal degeneration in cats, dogs, and rats following both oral and intravenous routes when administered at doses between 250-1600 mg/kg/day.7 As a result, visual abnormalities may occur in courses longer than 7 days. Therefore, ophthalmic exams should be conducted at baseline and at regular intervals to assess for visual acuity, color vision, and visual fields.7 While tranexamic acid is not approved by the Food and Drug Administration agency for the use of preventing total blood loss and decreasing the rate of blood transfusions in TKA and THA, there is enough literature to support its use in orthopedic surgeries. During orthopedic surgery, damage to blood vessels releases t-PA which can result in an increased lytic state, putting the patient at risk for postoperative anemia and bleeding. Tranexamic acid, by
22 • Arizona Journal of Pharmacy • Winter 2014
inhibiting plasmin, can decrease the risk of bleeding to patients undergoing orthopedic surgery. Studies have proven its efficacy in decreasing total blood loss and reducing the need for blood transfusions without increasing the risk of developing thromboembolic complications. Further studies are warranted to provide adequate dosing schemes for tranexamic acid’s use during total knee and hip arthroplasties. References: 1. Maxwell MJ, Wilson MJ. Complications of blood transfusions: continuing education in anesthesia, Crit Care & Pain. Nov 2006;6:225-9. 2. Iperna HJ and Tanzi MG. Use of topical tranexamic acid and aminocaproic acid to prevent bleeding after major surgical procedures. Ann Pharmacother. Jan 2012; 46: 97-107. 3. Grossc PL, Murray RK, Rand ML. Hemostasis & Thrombosis. In: Murray RK, Kennelly PJ, Rodwell VM et al. eds. Harper’s Illustrated Biochemistry. 29th ed. New York, NY: McGraw-Hill; 2011. http://www. accesspharmacy.com/content.aspx?aID=55886653. Accessed September 22, 2013. 4. CRASH-2 trial collaborators. Effects of tranexamic acid on death, vascular occlusive events, and blood transfusions in trauma patients with significant haemorrhage (CRASH-2): a randomized, placebo-controlled trial. The Lancet. 2010; DOI:10.1016/S0140-6736(10)60835-5. 5. Zehnder JL. Drugs Used in Disorders of Coagulation. In: Katzung BG, Masters SB, Trevor AJ, eds. Basic & Clinical Pharmacology. 12nd ed. New York, NY: McGraw-Hill; 2012. http://www. accesspharmacy.com/content.aspx?aID=55826748. Accessed September 16, 2013. 6. Dunn CJ and Goa KJ. Tranexamic acid a review of its use in surgery and other indications. Drugs. Jun 1999; 57(6):1005-1032. 7. Cyklokapron [package insert]. New York, NY: Pharmacia & Upjohn Co, Division of Pfizer Inc. 2013. 8. Lysteda [package insert]. Atlanta, GA: Ferring Pharmaceuticals Inc; 2011. 9. Lexi-Comp Online, Lexi-Drugs. Hudson, Ohio: Lexi-Comp, Inc.; September 20, 2013. 10. Toner RW, Pizzi L, Leas B, et al. Costs to hospitals of acquiring and processing blood in the US: a survey of hospital-based blood banks and transfusion services. Appl Health Econ Health Policy. Jan 2001;9(1): 29-37. 11. Gandhi R, Evans HMK, Mahomed SR, Mahomed NN. Tranexamic acid and the reduction of blood loss in total knee and hip arthroplasty: a meta-analysis. BMC Research Notes. 2013;6(184). 12. Irisson E, Hemon Y, Pauly V et al. Tranexamic acid reduces blood loss and financial cost in primary total hip and knee replacement surgery. Orthop Traumatol Surg Res. May 2012; 98: 477-483. 13. Poon BB, Witmer C, Pruemer J. Coagulation Disorders. In: DiPiro JT, Talbert RL, Yee GC, Matzke GR, Wells BG, Posey LM, eds. Pharmacotherapy: A Pathophysiologic Approach. 8th ed. New York, NY: McGraw-Hill; 2011. http://www.accesspharmacy. com/content.aspx?aID=8000061. Accessed September 23, 2013. 14. Maniar RN, Orth MS, Orth MCh, et al. Most effective regimen of tranexamic acid in knee arthroplasty: a prospective randomized controlled study in 240 patients. Clin Orthop Relat Res. 2012; 470: 2605-2612.
Featured Article AzPA Health-System Pharmacy Leadership Forum Update
by Lindsay Davis, Pharm.D., BCPS, Assistant Professor, Midwestern University College of Pharmacy - Glendale On November 8, 2013 the AzPA held a luncheon for the Health-System Pharmacy Leadership Forum (formerly known as the Directors of Pharmacy Forum) on the Banner Boswell Medical Center campus. The theme for this meeting was Transitions of Care: Best Practices to Reduce 30-day Hospital Readmission within Arizona Health-Systems and among the 23 attendees were pharmacy and residency directors, administrators, and faculty representing both Arizona Colleges of Pharmacy. The keynote speaker was Nicole Murdock, Pharm.D., BCPS, Associate Professor, Midwestern University College of Pharmacy – Glendale. Her presentation, titled Lessons Learned: Strategies for Improving Transitions of Care provided the audience background information about transitions of care (TOC) and exemplified her journey with TOC across 4 health-systems
including programs in Idaho, Washington and Arizona. She discussed different models for pharmacist involvement with TOC including “the common pharmacist,” “the medical home model pharmacist,” “the centralized pharmacist,” and “the specialty care pharmacist.” Through each example Dr. Murdock discussed outcomes measured and lessons learned. In addition to our keynote address, four other speakers presented their work with TOC. Kristin Calabro, Pharm.D., discussed a pilot TOC project with the University of Arizona Medication Therapy Management Program and Abrazo Health that focused on medication reconciliation post-hospital discharge. Tracy Lin, Pharm.D., CACP, shared her experience with the Cigna Medical Group Custom Care After the Hospital Program which provides TOC services after discharge until patients can be seen by their assigned primary care physician. Lauren Miller, Pharm.D., presented her work with a grant-funded project at the University of Arizona Medical Center that focused on discharge medication optimization. Elizabeth Pogge, Pharm.D., MPH, BCPS, FASCP, shared details about a new program she is involved with at Banner
SUPPORTING PHARMACISTS ADVANCING CAREERS Find the best jobs and highly qualified pharmacists Arizona has to offer.
Health called I-CARE which incorporates technology, telemedicine, and home visits to optimize TOC and manage complex patients at high risk of readmission. Lunch was sponsored by Asteres Inc. who provided a brief overview of their ScriptCenter® prescription delivery system which is currently being utilized in several hospital pharmacies across Arizona. The expanding roles and value of pharmacist involvement in direct patient care to optimize TOC were evident through the information presented during this meeting. Accordingly, future programming regarding TOC is underway. AzPA will continue to support this forum in meeting the needs of healthsystems leaders and plans to hold quarterly luncheon meetings. If you have any ideas for future meeting themes, current issues, or hot topics that would benefit discussion within this forum, please email Kelly Ridgway, AzPA CEO, at Kelly@ azpharmacy.org.
Arizona Pharmacy Association Mentor Connection Program
go ment t ors?
The AzPA Mentor Connection Program (AzPA MCP) provides the opportunity to build relationships, further professional networks, and strengthen continuous professional development on behalf of both mentors and mentees. The scope of this program supports AzPA’s vision of empowering pharmacy professionals to provide optimal patient care. AzPA MCP Program Goals • Promote personal and professional development of pharmacy students beyond curricular goals • Provide direction, foster confidence, and instill values needed to develop professionally • Create an engaging environment that instills renewed enthusiasm within the profession • Cultivate long-term relationships that evolve with time and are mutually beneficial Participation as a mentor or a mentee is open to all Arizona Pharmacy Association pharmacist (mentor) and student pharmacist (mentee) members.
ONLINE CAREER CENTER
www.azpharmacy.org/jobs
For more information about how to be a part of the AzPA MCP, contact Kelly Ridgway, AzPA CEO at kelly@azpharmacy.org
Arizona Journal of Pharmacy • Winter 2014 • 23
Drug Information Question
Question: Should HIV-infected adults receive the live attenuated herpes zoster vaccine? by Kristen Ching, Pharm.D., PGY1 Resident, and Virginia Boomershine, Pharm.D., BCACP, RPD, Walgreens and Midwestern University College of Pharmacy-Glendale
Answer: Introduction Herpes zoster (HZ) is caused by the reactivation of the latent varicella-zoster virus (VZV) within the dorsal root ganglia following an earlier episode of varicella, or chickenpox. HZ presents clinically as a painful, vesicular rash that is limited to the dermatome innervated by the infected ganglion. Debilitating complications of HZ include postherpetic neuralgia (PHN), bacterial skin infections, vision loss due to optic dermatome involvement, and disseminated HZ.1,2 Individuals infected with the human immunodeficiency virus (HIV) have a higher incidence of HZ and its associated complications.1-4 Varivax® and Zostavax® are 2 VZV vaccines approved by the Food and Drug Administration. Varivax® is a 2-dose varicella series indicated to prevent chickenpox in those 12 months of age and older.5 Zostavax® is a single-dose zoster vaccine (ZV) indicated to prevent HZ in individuals 50 years of age and older.6 Both vaccines contain the same strain of live attenuated VZV; however, Zostavax® contains 14 times more viral antigen than Varivax®, which is necessary to boost the cell-mediated immunity in adults previously infected with varicella.2 The Advisory Committee on Immunization Practices (ACIP) recommends routine immunization with the ZV in those 60 years of age and older regardless of a prior episode of HZ. Since there is a theoretical risk of virus dissemination from live virus vaccines, Zostavax® is not recommended for use in persons with primary or acquired immunodeficiency, including persons with acquired immunodeficiency syndrome (AIDS) or other clinical manifestations of HIV.1 Specifically, ZV is contraindicated in HIV-infected adults with CD4 counts < 200 cells/µL or < 15% of total lymphocytes. Currently, ACIP has no recommendations for ZV use in HIV-infected adults with CD4 counts ≥ 200 cells/ µL; however, 2 doses of Varivax® is recommended in this population.7 In a search of PubMed, there were no published studies of ZV use in HIV-infected adults. However, there was 1 randomized controlled trial that studied the safety and immunogenicity of Varivax® in HIV-infected adults. Although not published, a search of ClinicalTrials.gov revealed a recently completed randomized controlled trial investigating the safety and immunogenicity of Zostavax® in HIV-infected adults. Clinical Trials Weinberg et al. conducted a randomized, single-blinded, placebo-controlled study to evaluate the safety and immunogenicity of Varivax® for protecting HIV-infected adults against HZ.8 This study was conducted at the University of Pennsylvania and enrolled 82 subjects who were ≥ 18 years of age, VZV-seropositive, and had no prior history of HZ upon entry. The baseline median HIV RNA levels were < 75 copies/mL (undetectable viral load) and the median CD4 count ranged between 496 and 742 cells/μL.8,9 Furthermore, the mean age of the population ranged between 43.6 and 46.4 years and the majority of the subjects were black males. The 24 • Arizona Journal of Pharmacy • Winter 2014
study population was divided into 3 cohorts; cohort 1 were HIV-infected individuals with a CD4 nadir ≥ 400 cells/µL on stable treatment management (either therapy or none) for > 3 months (36 subjects); cohort 2 were HIV-infected individuals with a CD4 nadir < 200 cells/µL at a point, but were > 400 cells/µL at the study entry after ≥ 12 months of highly active antiretroviral therapy (31 subjects); and cohort 3 were healthy HIV-negative age-matched controls (15 subjects). Subjects from each HIV-infected cohort were randomized 1:1 to receive 2 doses of Varivax® or placebo 12 weeks apart in a blocked stratified design matched on age and sex. The HIV-negative controls received Varivax® at the same interval. All adverse events that occurred within 42 days of vaccination were recorded and graded according to the Divisions of AIDS (DAIDS) Toxicity Table for Grading Severity of Adverse Experiences. VZV-specific cell-mediated immunity (CMI) was measured by responder cell frequency (RCF), lymphocyte proliferation assay (LPA), and ELISPOT at weeks 0, 12, and 24. At least 15 subjects per cohort were required to provide 87% power to detect a 30% rate of side effects and 78% power to detect a 4% rate of immunologic boost. Power was met and the inclusion of the placebo recipients further provided this study with ≥ 80% power to detect a 50% RCF-measured response in vaccines. Most adverse events that occurred were grade 1 or 2 (mild) and were equally common in both HIV-infected cohorts. Data was not provided regarding adverse events grade > 2 or about adverse events in the HIVnegative controls. Within the HIV-infected subjects, there were no statistically significant differences in the occurrence of adverse events between vaccine and placebo recipients and less adverse events occurred after the second injection compared to the first injection in both vaccine and placebo recipients. The difference in VZV-specific CMI from baseline to 12 weeks after the second immunization was not statistically significant in the individual cohorts of HIV-infected subjects, cohorts 1 and 2. However, when grouped together, there was a statistically significant increase in RCF values (p= 0.02) and a trend towards an increase in ELISPOT results (p=0.08), but not in LPA in the HIV-injected subjects. Conversely, all values of VZV-specific CMI in the HIVnegative cohort at 12 weeks after the second immunization were significantly increased compared to the baseline values. The investigators concluded that Varivax® was safe and well tolerated by VZV-seropositive HIV-infected adults with CD4 counts ≥ 400 cells/µL regardless of their CD4 nadir. Adverse events probably or possibly related to the vaccine were mild and equally frequent among vaccine and placebo recipients. Also, the immunogenicity of the varicella vaccine was determined to be low in HIV-infected subjects. Benson et al. recently completed a study investigating the use of Zostavax® in HIV-infected adults.10,11 This study was a randomized, double-blinded, placebo-controlled trial that evaluated the safety and immunogenicity of 2 doses of ZV in HIV-infected individuals with CD4 counts ≥ 200 cells/µL. This
Drug Information Question (continued from page 24) study was conducted at 43 centers across the United States and the entry criteria included age ≥ 18 years with HIV; CD4 counts ≥ 200 cells/μL; on a potent antiretroviral therapy (ART); undetectable plasma HIV RNA levels within 90 to 210 days prior to the study; and seropositive for VZV or a history of VZV or HZ greater than 1 year prior to entry. The average age of the study population ranged between 44 and 56 years, with the majority being white non-Hispanic males with a prior history of AIDS and no prior history of HZ. The average CD4 count upon entry ranged between 362 and 399 cells/μL and the HIV RNA ranged between 1.68 and 1.70 copies/mL. Participants were randomized 3:1 to receive either 2 doses of ZV or placebo 6 weeks apart and were followed for at least 42 days after each dose. The primary outcome was the composite safety endpoint measured by the occurrence of serious adverse events (SAEs) or DAIDS grade 3 and 4 and symptoms during the 6 weeks following a dose of ZV or placebo. This study was not powered to detect safety-related differences between treatment arms. Instead, the safety of Zostavax® was determined by comparing the number of vaccinated subjects who experienced the safety endpoint to the number from a pre-specified decision rule. This was calculated based on a similar population and calibrated using the number of safety endpoints observed from the placebo group. Acceptable safety of ZV was met if no more than 18 subjects experienced a study-defined composite safety endpoint. The secondary endpoint was immunogenicity via the measurement of VZV antibodies by gpELISA within 6 weeks following a dose of ZV or placebo. Based on the preliminary results of this trial, 15 of the 295 patients in the ZV group and 2 of the 97 patients in the placebo group met the pre-defined safety endpoint (p=0.26). However, these SAEs were not considered vaccine-related. The mean VZV antibody titers measured by gpELISA increased from 5.68 at baseline to 6.28 and 6.27 at 6 weeks after the first and second dose of ZV, respectively. The mean VZV antibody titers were 5.52 at baseline and 5.57 and 5.52 at 6 weeks after the first and second dose of placebo, respectively. There was a statistically significant difference in the VZV antibody titer after each immunization between the Zostavax® and the placebo arm (95% CI, 0.45 to 0.69; p<0.001). The investigators concluded that 2 doses of Zostavax® were generally safe and moderately immunogenic in those infected with HIV. Discussion These 2 clinical trials presented beneficial results regarding the use of VZV vaccinations in HIV-infected adults with CD4 counts ≥ 200 cells/µL. The safety profiles for both vaccines were concluded to be acceptable, with the most common adverse effects experienced being injection site reactions (i.e., pain and redness at the injection site). These findings were consistent with another study in which 2 doses of the varicella vaccine were administered to HIV-infected VZV-seropositive children who were receiving highly active antiretroviral therapy (HAART) and had low or undetectable viral levels. There were no serious adverse events recorded during the 42 days after the second vaccination, including the development of HZ throughout the 2 years of the trial.12 The low immunogenicity of Varivax® and moderate immunogenicity of Zostavax® in HIV-infected individuals suggest that a more potent VZV vaccine is required to elicit an immune response in this population. The immunogenicity result
from the Zostavax® trial indicates its possible effectiveness to prevent the reactivation of VZV in this population. However, the duration of this trial was not long enough to have a definite conclusion. A study investigating the effectiveness of the varicella vaccine in HIV-infected children with a median CD4 count range of 760 to 1161 cells/μL and a median follow-up time of 4.4 years concluded that the varicella vaccine is highly effective to prevent HZ in HIV-infected children. However, this was a longitudinal cohort study, not a randomized controlled trial, and the data was obtained via review of medical records.13 In summary, although the ACIP does not recommend for or against the use of Zostavax® in HIV-infected adults with CD4 counts ≥ 200 cells/µL, the vaccine is likely to be safe and possibly immunogenic in those with CD4 counts ≥ 200 cells/µL, undetectable HIV RNA levels, and on potent ART. Zostavax® may be beneficial in preventing HZ, but more studies are needed to elucidate its long-term efficacy in preventing HZ. References 1. Centers for Disease Control and Prevention (CDC). Prevention of herpes zoster recommendations of the advisory committee on immunization practices (ACIP). MMWR Recomm Rep. 2008;57(RR-5):1-40. 2. Oxman MN, Levin MJ, Johnson GR, et al. A vaccine to prevent herpes zoster and postherpetic neuralgia in older adults. N Engl J Med. 2005;352:2271-2284. 3. Chen SY, Suaya JA, Li Q, et al. Incidence of herpes zoster in patients with altered immune function. Infection. 2013. [Epub ahead of print]. 4. Moanna A, Rimland D. Decreasing incidence of herpes zoster in highly active antiretroviral therapy era. Clin Infect Dis. 2013;57(1):122-125. 5. Varivax® [package insert]. Whitehouse Station, NJ: Merck & Co; 2013. 6.Zostavax® [package insert]. Whitehouse Station, NJ: Merck & Co; 2006. 7. Centers for Disease Control and Prevention (CDC). Advisory committee on immunization practices (ACIP) recommended immunization schedules for persons aged 0 through 18 years and adults aged 19 years and older United States, 2013. MMWR Recomm Rep. 2013;62(Suppl 1):1-19. 8. Weinberg A, Levin MJ, MacGregor RR. Safety and immunogenicity of a live attenuated varicella vaccine in VZV-seropositive HIV-infected adults. Hum Vaccin. 2010 Apr;6(4):318-321. 9. Panel on antiretroviral guidelines for adults and adolescents. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents. Department of Health and Human Services. Available at http://aidsinfo.nih.gov/ ContentFiles/AdultandAdolescentGL.pdf. Section accessed 2013 Nov 26. C-7. 10. National Institute of Allergy and Infectious Disease. Live zoster vaccine in HIV-infected adults on antiretroviral therapy. In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000 [cited 2013 Nov 19]. Available from: http://clinicaltrials.gov/ct2/show/study/NCT00851786 NLM Identifier: NCT00851786. 11. Benson CA, Hua L, Andersen JW, et al. ZOSTAVAX® is generally safe and immunogenic in HIV-infected adults with CD4 counts > 200 cells/µL virologically suppressed on antiretroviral therapy: results of a phase 2, randomized, double-blind, placebo-controlled trial. 19th Conference on Retroviruses and Opportunistic Infections Medical Meeting. Seattle, WA, Abstract CROI A5247. March 5-8. 2012. 12. Gershon AA, Levin MJ, Weinberg A, et al. A phase I-II study of live attenuated varicella-zoster virus vaccine to boost immunity in human immunodeficiency virus-infected children with previous varicella. Pediatr Infect Dis J. 2009;28(7):653-655. 13. Moeun Son BA, Shapiro ED, LaRussa P, et al. Effectiveness of varicella vaccine in children infected with human immunodeficiency virus (HIV). J Infect Dis. 2010;201(12):1806-1810.
Winter 2014 • Arizona Journal of Pharmacy • 25
Student Perspective Improving Patient Adherence through Medication Synchronization and the Appointment-Based Model
by Sophia Galloway, Pharm.D. Candidate, Midwestern University College of Pharmacy- Glendale, Class of 2014 Poor medication adherence leads to poorer health, more frequent hospitalizations, higher risk of death, and up to $290 billion in increased medical costs each year. Pharmacists play a critical role in facilitating proper medication use and helping patients to maintain high levels of adherence and persistence to their medication regimen. An emerging opportunity for pharmacists and pharmacy staff members to help patients manage their medications while also improving pharmacy efficiency is through the Appointment-Based Model (ABM). The ABM was designed in 1995 by John Sykora, a pharmacist in Long Beach, California, and is a way for pharmacists to provide individualized, convenient patient care with the ultimate goal of optimizing patient outcomes and pharmacy efficiency. The focus of the ABM is medication synchronization, which consists of coordinating or “synchronizing” all of a patient’s chronic medications to be filled on the same day of each month. Such programs have been shown to improve patients’ ability to take their medications as prescribed, improve patient satisfaction, and free pharmacists to focus on other clinical services such as immunizations and medication therapy management. To implement the ABM, pharmacy personnel should identify patients taking multiple chronic medications, especially those that may be having adherence issues or those who make several trips to the pharmacy each month to pick up their medications. Once patients are enrolled, they may need partial prescription refills for some medications until all medications are synchronized. This is usually done with the least expensive medications, scheduling the monthly fill time around the more expensive “anchor” medications. It may take two to three months to obtain synchronization, and refill quantities may need to be adjusted accordingly. The pharmacist can work closely with the provider to obtain new prescriptions for all chronic medications simultaneously, each written for the same day supply with the same number of refills to help keep the patient on track. Once a patient’s medications are synchronized, pharmacy personnel will contact the patient several days before his or her scheduled appointment date to ensure that he or she is still taking all of the synchronized medications and that there have been no recent hospitalizations or changes to medication therapy. The pharmacy will then fill the prescriptions and await the patient’s appointment, which is scheduled on or extremely close to their monthly fill date. This will result in the patient making only one trip to the pharmacy each month to pick up his or her chronic medications. The most important piece of this model is the opportunity for pharmacist intervention at each appointment. The monthly interaction between the pharmacist and the patient can be used, not only for counseling and answering questions, but also for services such as comprehensive medication reviews, immunizations, and health screenings. This results in a more engaged, healthier patient who has a personal relationship with his or her pharmacist. One example of successful implementation of the Appointment-Based Model is Thrifty White Pharmacy, a chain of
26 • Arizona Journal of Pharmacy • Winter 2014
pharmacies located in rural Minnesota, Wisconsin, North Dakota, Iowa, and Montana. This pharmacy chain studied the impact of the ABM on patient adherence and persistence to medications as compared to control patients not utilizing the ABM. The analysis indicated significant improvements in adherence and persistence for the ABM patients when compared with the control patients for all of the medication classes that were studied. Depending on the drug class, patients enrolled in the program had 3.4 to 6.1 times greater odds of adherence than the controls during the study period. It was also found that control patients had a 52% to 73% greater likelihood of becoming non-persistent, or more likely to stop taking their medications pre-maturely, depending on drug class. In conclusion, there is evidence to show that the ABM improves the likelihood that patients with chronic medical conditions will take their medications as prescribed and not discontinue their medication therapy prematurely. On a local level, the Appointment-Based Model is being implemented by several pharmacies and community health centers in the Phoenix and Tucson areas. In the fall of 2013, the American Pharmacists Association (APhA) Foundation partnered with an Accountable Care Organization (Arizona Connected Care), a community pharmacy chain (Fry’s Pharmacy), and a group of federally qualified health centers (El Rio Community Health Centers), in an effort to demonstrate the impact that the ABM can have on adherence for patients of an Accountable Care Organization (ACO). Fry’s Pharmacy and El Rio Community Health Center are each implementing their own versions of the Appointment-Based Model to determine how the ABM affects patient adherence in each of their settings. In October 2012, prior to their partnership with the APhA Foundation, Fry’s began enrolling patients in their medication synchronization program. Currently, Fry’s has over 800 patients enrolled in the Phoenix and Tucson areas. Pharmacists at the Fry’s Pharmacy Call Center contact patients that may benefit from the program. These patients are identified either by the individual Fry’s pharmacies themselves, or through CareMore, a health plan for Medicare beneficiaries. Once enrolled, pharmacists at the call center manage the medication synchronization process, contact the physicians as necessary, and handle all insurance issues. Pharmacists at the call center also contact the patients regarding their appointments and remotely enter the prescriptions into the workflow of the Fry’s Pharmacy of the patients’ choosing near their appointment date. When a patient arrives at the pharmacy for their monthly appointment, the pharmacist has the opportunity to counsel the patient on his or her medications, answer any questions or resolve any problems that the patient may have, and provide additional clinical services. “As pharmacists seek provider status and reimbursement for their clinical services, it is important that patients view their pharmacy as a ‘healthcare destination,’ not just a place to pick up a product,” says Rod Shafer, staff pharmacist at the Fry’s Pharmacy Call Center. “The [ABM] is a way for pharmacists to change that perception.” Not only is the medication synchronization convenient for the patient, but when pharmacies know exactly when a patient is coming in each month, inventory is easier to maintain and workflow is better managed, allowing the pharmacist more time to provide clinical services. El Rio Community Health Center in Tucson, Arizona is in the process of implementing their version of the Appointment-Based Model at each of their clinics. Here, pharmacy
Student Perspective Medication Synchronization (continued from page 26) technicians are being trained to do the initial work-up of the patient and synchronization of the medications. Pharmacists in these facilities have collaborative practice agreements with the prescribers, giving the pharmacists the ability to make the necessary changes to the prescriptions in order to get patients’ medications synchronized. Pharmacists also have access to patients’ electronic health records and are in close proximity to the prescribers (located within the same facility), both of which ease medication synchronization issues and allow for better continuum of care. On their appointment date, many patients require intensive medication and disease state counseling by the clinical pharmacist, a valuable service that will potentially prevent adverse outcomes in the future. Dr. Sandra Leal, clinical pharmacist at El Rio’s Congress Clinic, hopes to demonstrate that the ABM increases patients’ adherence to their medications, thereby improving patient outcomes, decreasing hospitalizations and medical claims, and reducing overall medical costs. “The fee-for-service model [where payment for services is dependent on quantity of care rather than quality of care] is not as relevant anymore,” says Dr. Leal. “As we move toward the pay-forperformance model, it will be easier to justify the value of the clinical pharmacy services we are providing and create opportunities for shared cost-savings and reimbursement.” We know that the ABM and medication synchronization can improve patient adherence, but several barriers exist to this model. The process of synchronizing refills often requires the adjustment of refills or written quantities on some of the prescriptions in order to get all of a patient’s chronic medication fills aligned. This may result in a patient losing a refill or necessitate a new prescription from the prescriber sooner than originally planned. This process could be simplified if pharmacists had the authority to adjust written quantities or add refills to existing prescriptions for non-controlled, chronic medications solely for the purpose of medication synchronization. Pharmacists with collaborative practice agreements with prescribers can currently make the adjustment for patient convenience, but pharmacists without these agreements must call the prescriber in order to make any changes. Modification of the state’s Pharmacy Practice Act to allow for pharmacists to adjust refill quantities solely for the purpose of medication synchronization would help simplify the process and allow for refill autonomy. Other barriers to the ABM exist with the third party payers. When synchronizing patients’ medications, some prescriptions will be deemed “refill too soon” by the third party. Some insurance companies will only allow one claim to be processed per 30-day period, making it difficult to fill necessary prescriptions before their technical due date for the purpose of medication synchronization. One state, Connecticut, has already addressed this issue by passing legislation stating that “Effective January 1, 2014: No health insurance policy may deny coverage to a claim that is made in order to synchronize medication refills.” To facilitate the medication synchronization process and resolve this barrier on a national level, the National Council for Prescription Drug Programs (NCPDP) has approved two new submission clarification codes that allow pharmacies to request an override to plan limitations when a shortened day supply is being dispensed. In order for medication synchronization to be an option for any patient who desires it, more states will need
to follow suit with legislation to allow patients with any health plan to have access to the program without an additional financial burden. The NCPDP initiative helps to ensure that the proper steps are in place once the legislation is approved. Another issue with third parties is the current co-pay structure of some plans, charging patients the same price for a partialmonth supply as they would for a 30-day supply. Upon initiation of the ABM, prescriptions other than the anchor medication must be filled for either more than or less than 30 days in order to get the medications synchronized. This presents a financial burden to either the patient or the pharmacy. This barrier has already been addressed by Medicare. Beginning January 1, 2014, all Medicare Part D plans will be required to institute daily cost-sharing to enable medication synchronization. This allows pharmacies to fill less than a 30-day supply of a medication, and the patient will be charged a pro-rated rate based on the number of days that are actually filled. This provision only applies to oral solid medications and excludes antibiotics. Similar provisions will need to be made by private third parties and Medicaid programs to ensure patients have full access to the ABM and do not face a financial burden as a result. Additional third party restrictions such as mandatory mail order requirements for filling a 90-day supply pose further challenges for patients trying to participate in the ABM at their local pharmacy. This can lead to problems with medication synchronization and also reduces the number of opportunities for patients to interact with their pharmacist on a face-to-face level.
The Arizona Pharmacy Association presents PTCB EXAM REVIEW COURSE COMPLETELY REVISED CONDUCTED IN 7 ONLINE PRE-RECORDED WEBINARS*. Only $395 Go to www.azpharmacy.org to register. *Class requirements: Internet connectivity, Windows Media Player and Adobe Acrobat Reader are required for participation in this class. System Requirements PC-based attendees • Required: Windows® 7, Vista, XP or 2003 Server Macintosh®-based attendees • Required: Mac OS® X 10.6 or newer Mobile attendees • Required: iPhone®, iPad®, Android™ phone or Android tablet NOTE: This course does not provide training to become a pharmacy technician. It is intended for those preparing to take the PTCB technician certification exam. Prior work experience is strongly recommended. This review course does not include nor does it register you for the PTCB National Certification Exam. Winter 2014 • Arizona Journal of Pharmacy • 27
Student Perspective Medication Synchronization (continued from page 27) In addition, there are concerns from pharmacies about third party audits. Pharmacies fear that filling a prescription for less than a 30-day supply when initiating the medication synchronization process will raise scrutiny from auditors who may perceive this as a way to collect multiple dispensing fees for a medication within a 30-day period. Another issue that should be addressed with patients enrolled in the ABM is poly-pharmacy. Patients should be educated that they will benefit most from the ABM if they receive all of their prescriptions from the same pharmacy. This ensures that their physicians and pharmacists remain informed regarding the patient’s current care. This also ensures that a comprehensive drug utilization review is being performed at each appointment. Lack of payment to pharmacies for the ABM services is, perhaps, the largest barrier to widespread implementation of the model. Although the health benefits to the patients are substantial, it takes a lot of time and manpower to implement the ABM. Therefore, it is essential that a billing and payment mechanism be developed for the initiation of the medication synchronization service, as well as for maintenance of the ABM so that more patients can receive this care. By building enrollment in the ABM and demonstrating to private payers the value of the ABM services, contracts may be developed for pharmacies to receive payment for these services. In addition, legislative initiatives need to take place to allow for payment
Do you know someone who is not a member of the Arizona Pharmacy Association . . . and should be?! Invite them to join the only statewide organization that represents the pharmacy profession in Arizona. Annual dues for a pharmacist are just $20 per month! This equates to: • Approximately 2/10 of 1% of the annual wage for a new practitioner pharmacist • Less than 5 hours of work per year, after taxes • Less than 62 cents per day Visit the AzPA website at www.azpharmacy.org to join online or to download a printable Membership Investment Statement. AzPA values its members and recognizes that your time is valuable. Monthly payment plans are available for pharmacist membership categories, as well as an automatic annual renewal option, when you provide your credit card information.
Arizona Pharmacy Association
28 • Arizona Journal of Pharmacy • Winter 2014
provisions for patients enrolled in Medicare and Medicaid programs who benefit from the ABM services. The Appointment-Based Model improves patient care by simplifying patients’ medication regimens and facilitating a monthly review of patients’ prescription and over-the-counter medications. It also provides an opportunity to identify and resolve medication non-adherence issues and potentially reduce medication-related hospital readmissions. In addition, the ABM facilitates team-based care and open communication between pharmacists and prescribers. The Appointment-Based Model shifts the pharmacy staff’s focus from reactive to proactive, filling prescriptions based on a patient’s scheduled appointment date versus filling prescriptions unaligned throughout the month at the request of the patient. The ABM increases prescription volume and creates operational efficiencies such as inventory and labor. The ABM also benefits prescribers by eliminating last minute refill requests and prior authorizations. Currently, the APhA Foundation, National Community Pharmacists Association (NCPA) and the National Alliance of State Pharmacy Associations (NASPA) are launching nationwide initiatives, all studying the impact of the ABM and helping pharmacies to implement the Appointment-Based Model in their pharmacies. Moving forward, increasing pharmacy and patient awareness about the ABM will make enrollment easier and increase the demand for payment for the pharmacy services being provided. Educating prescribers about the model is also important, as they will become familiar with the program and can refer patients who may be having adherence issues to your pharmacy to enroll in the program. State and national associations must work together to make legislative and regulatory changes, collaborating directly with third parties to demonstrate the value of the clinical pharmacy services provided by the ABM. For more information about the Appointment-Based Model, or for resources to help you implement the ABM in your pharmacy, visit: http://www.aphafoundation.org/, http://www.naspa.us/, and www.ncpanet.org. References • APhA Foundation. Pharmacy’s Appointment Based Model (ABM). http:// www.aphafoundation.org/appointment-based-model. Accessed November 2013. • Dolan, B. Poor Medication Adherence Costs $290 billion a year. New England Healthcare Institute. 15 Aug 2009. http://mobihealthnews. com/3901/poor-medication-adherence-costs-290-billion-a-year. Accessed December 2013. • Holdford D, Inocencio T. Patient Centric Model Pilot Data Analysis Final Report. Prepared for The Alliance for Patient Medication Safety. Virginia Commonwealth University. http://www.naspa.us/documents/grants/abm/ NASPA%20Report%204-08 2011%20Final%20Reports.pdf. Accessed November 2013. • National Alliance of State Pharmacy Associations. Appointment Based Model (ABM). http://www.naspa.us/grants/abm.html. Accessed November 2013. • National Community Pharmacists Association. Preview of Simplify My Meds. http://www.ncpanet.org/index.php/preview-of-simplify-my-meds. Accessed November 2013. • State of Connecticut. Public Act No. 13-131. http://www.cga.ct.gov/2013/ act/pa/2013PA-00131-R00HB-05767-PA.htm. Accessed November 2013. • Traynor K. Synchronized Prescription Fills Improve Patients’ Medication Adherence. AJHP News. 15 Jul 2013. http://www.ashp.org/menu/News/ PharmacyNews/NewsArticle.aspx?id=3920. Accessed November 2013.
Academy News Community Practice Academy I am very honored and proud to represent the Community Practice Academy this year. We are off to a good start with an executive committee that is eager to begin working to help all members of the CPA. Our executive committee consists of: Betty Louton – Academy Chair Kristen Calabro – Academy Past Chair Nicole Romney – Communications Committee Lori Drea – CE Committee
Grace Akoh-Arrey – Academy Chair Elect Carolyn Johnson – Legislative Committee Ashley Kalchthaler – Membership Committee
Thank you all for volunteering to be actively involved in our academy. With an active Executive Committee this academy can achieve a number of very important things. This committee is committed to disseminate pertinent information to the Academy. We are working diligently to continue communications with our wholesale suppliers, the Board of Pharmacy, the DEA, and the medical board to reach some sort of middle ground to stop the abuse of controlled substances and allow our pharmacies to continue to serve our patients. As we are all aware, arbitrary caps have been placed on all pharmacies’ ability to order controlled substances. While this is a difficult situation for the major chains, it is devastating to our independent pharmacy owners. Be sure to attend the Arizona Pharmacy Symposium on Satruday, February 22, 2014 featuring a panel discussion on this topic. Details on page 7. This is only one of our many projects. We still need volunteers to work on any of the above committees as well as on the steering committee for the Annual Convention. Please consider working on the committee to enable our Academy to be well represented at the Annual Convention at The Wigwam this year. If any members have any concerns or comments, please contact me, or any CPA Executive Committee Member through the AzPA Office, or join us on our conference calls on the third Thursday of every month at 7:30 am. We are here to serve you, and enhance the practice of pharmacy in these ever changing times. Thank you for your membership and support.
Betty Louton, Pharm.D. Community Pharmacy Academy Chair cpa@azpharmacy.org
Geriatric Care Academy The GCA has had a busy and productive fall. The AzPA Fall Pharmacy Conference was held at the Desert Willow Conference Center in Phoenix on October 26, 2013. The conference, Expanding the Partnership of Pharmacy Care, had 83 participants who enjoyed a dynamic topic lineup. Geriatric topics included antipsychotics, the target specific oral anticoagulants, and an update on immunizations in the elderly. Thank you to all who attended as well as those who volunteered to give a CE presentation. The 2013 ASCP Annual Meeting & Exhibition was held on November 20-22nd in Seattle, Washington. The meeting was wellattended and included many timely topics such as transitions of care and the changing landscape of health care. The 2014 ASCP Midyear Meeting has been cancelled, so the next meeting is in November 2014. I will keep you updated on this important opportunity to connect with the ASCP as the 2014 conference gets closer. As a reminder, the GCA meets via monthly conference calls on the second Wednesday of the month at 12 noon. I know that not everyone is able to attend these calls, so keep an eye out for additional e-mails and updates from the GCA. I invite everyone that is interested in geriatrics to get more involved! If you are considering getting more involved in the GCA or have any questions, please e-mail me at gca@azpharmacy.org.
Elizabeth Pogge, Pharm.D., MPH, BCPS, FASCP Geriatric Care Academy Chair gca@azpharmacy.org Winter 2014 • Arizona Journal of Pharmacy • 29
Academy News Health-System Academy News “Tomorrow, is the first blank page of a 365 page book. Write a good one.”
― Brad Paisley
The HSA has many ‘chapters’ in the works for 2014: 1. The Conference Planning Committee has already met and are developing curriculum for the Southwestern Clinical Pharmacy Seminar. If you are interested in participating contact Chairs Mitch Buckley or Patty Ritz (at hsa@azpharmacy.org). We are looking for speakers and poster presenters to educate our members this Spring. Please look for more specific information to come regarding location and registration. 2. Thank you to all those participating in the Mentor Connection Program! I know a lot of good information is being shared among participants. We have a record number of mentors and preceptors this year. Way to go! 3. Please watch for our New Practitioner events which will be taking place in Phoenix and Tucson this Spring. If you are interested in helping plan those events please contact Scott Hall or Abbey Siegler (at hsa@azpharmacy.org). 4. I hope you voted during our ASHP House of Delegates Election, as we have two positions open this year! Our Arizona Delegation is making waves nationally for promoting pharmacists as providers as well as promoting other pharmacy policies. Thank you to Carol Rollins, Mindy Burnworth and Christi Jen for their fabulous work. If you have ideas for policies or issues you would like addressed at future meetings, please email them to hsa@azpharmacy.org. 5. We are always looking for new ideas, if you want to get involved with the HSA drop us a line at hsa@azpharmacy.org. We are already recruiting for new chairs and representatives for 2014-2015, so please email me or any member of the HSA Executive Committee if you are interested. WE WANT YOU! I cannot see what ‘book’ the HSA is able to write this year without your help. Let’s make the most of it.
Kristen Allison, Pharm.D., BCPS, BCPP Health-System Academy Chair hsa@azpharmacy.org The Health-System Academy of the Arizona Pharmacy Association is the Arizona affiliate of the American Society of Health-System Pharmacists (ASHP).
Managed Care Academy News The Managed Care Academy is busy developing continuing education topics for upcoming AzPA conferences. Proposed subjects include: 1. CQI – hot topic for 2014 with the Arizona State Board of Pharmacy enforcement looming 2. Transitions of Care – a very timely subject with the changes to health care on the horizon 3. 5-Star Ratings – a possible panel discussion to focus on criteria for evaluations If you have other topics or speakers to recommend for AzPA programs, please contact me at mca@azpharmacy.org. We are still looking for volunteers to serve on the AzPA Communications Committee and the Annual Convention Planning Committee. The time commitment for these committees is minimal - generally one teleconference meeting per month - but volunteer involvement is crucial to the success of our Association. Please consider offering your talents to one of these committees. The next Managed Care Academy conference call is Thursday, January 16, 2014 at 7 am. All MCA members are invited to attend. Please plan to dial in and get involved with our Academy.
Eric Luecht, R.Ph. Managed Care Academy Chair mca@azpharmacy.org
30 • Arizona Journal of Pharmacy • Winter 2014
Academy News Student Pharmacist Academy News The AzPA-SPA executive board at both the University of Arizona and Midwestern University recently completed the membership drive. It was a great success, with over 100 students register as new members. The SPA at the University of Arizona had two lunch meetings for its members. At our first lunch meeting Dr. Whitney Shields spoke to us about the importance of staying active with AzPA and highlighted AzPA Health-System Academy’s affiliation with ASHP. during the second lunch meeting, AzPA CEO Kelly Ridgway spoke to the students about the benefits of AzPA membership and the Associations’s accomplishments. Kelly also spoke on political advocacy and how student members can become more involved. At Midwestern, students celebrated October as Pharmacists Month by promoting the Power Me A to Z Campaign. The SPA hosted a luncheon to educate students from other health care programs on the importance of folic acid as well as the community’s easy access to pharmacists to ask questions regarding pre-natal health. Student volunteers also educated children on the dangers of prescription drug abuse at Safe Halloween, a trick-or-treating event that is held annually on campus. Children had an opportunity to play a game to distinguish candy from medicine and parents had an opportunity to ask about the role of pharmacists. The students of Midwestern will also be providing volunteers for the American Diabetes Association’s Health Forum in Mesa in December. Plans are underway for the Pharmacy Day at the State Capitol. Plan to attend on Wednesday, February 12, 2014. Details are on page 6. Sabrina Pennock, SPA Co-Chair, Midwestern University College of Pharmacy Glendale spennock67@midwestern.edu Pritesh Patel, SPA Co-Chair, University of Arizona College of Pharmacy pritesh.patel@pharmacy.arizona.edu
Technician Academy News Happy New Year! The Technician Academy has been very busy this past quarter! We have added the following members to our executive committee to represent us on other AzPA committees: • Kalani Anderson – Legislative Affairs Committee and Communications Committee • Josh Kramer – Membership Committee and Continuing Education Committee • Sara Alvis – Managed Care Academy We are still looking for representatives for Geriatric Care Academy, Health System Academy, and Community Practice Academies! If interested, contact me, Judi Day (tech@azpharmacy.org). We assisted with CE programs for technicians presented at the AzPA Fall Pharmacy Conference at the Desert Willow on October 26th. Twenty-six percent of the members present were technicians! We are particularly proud of the technician-only CEs offered at this conference including Josh Kramer’s Advancing the Scope of Practice for Pharmacy Technicians. Josh spoke about how the PTCB will require all applicants for certification to complete an ASHP-accredited program before sitting for the exam beginning in 2020. Equally exciting was The Technician’s Role in Diabetes Meter Selection and Training. Dr. Grace Akoh-Arrey and student pharmacists Sophia Galloway and Daniel Doetsch demystified the process of helping a patient choose a meter and showing them how to use it. They even hinted that an upcoming technician certification program on the subject was in development! This would be a first-of-itskind offering through the AzPA! Lastly, we have had many group discussions in our monthly Technician Academy calls to develop criteria for special recognition for technicians who demonstrate extraordinary commitment to the profession. This is in a very early stage of development. Look for an announcement for 2015. We would love for you to join our monthly calls. Announcements are sent via email to affiliated AzPA Technician Academy members so be sure your email address is current in the data base.
Judi Day, C.Ph.T Technician Academy Chair tech@azpharmacy.org Winter 2014 • Arizona Journal of Pharmacy • 31
Continuing Education
Considerations in the Management of Generalized Anxiety Disorder
by Nicole K. Kitts, Pharm.D., BCPS, , Assistant Professor, Midwestern University College of Pharmacy – Glendale Goal patients of European decent are more Table 2: Symptoms of GAD5 This home-study CE activity was likely to be diagnosed with GAD than Psychological Physical developed to educate pharmacists other individuals.2 Patients with GAD Excessive anxiety Restlessness on the etiology, diagnosis, and often suffer from other comorbidities, Difficult to control Fatigue worries Muscle tension treatment (pharmacological and nonthe most common being depression, that Feeling on edge Sleep disturbances pharmacological) of generalized anxiety further reduce quality of life and may Poor concentration Irritability disorder. worsen prognosis for these patients.1 Objectives 1. Describe the clinical presentation of generalized anxiety disorder 2. List the advantages and disadvantages of the various pharmacological and nonpharmacological treatment options for generalized anxiety disorder 3. Recommend an appropriate firstline regimen for a patient with generalized anxiety disorder Background Generalized anxiety disorder (GAD) is a condition characterized by ongoing, significant amounts of worry or anxiety regarding a variety of events or activities, without a specific cause, that continue for at least six months. Patients diagnosed with GAD suffer from extreme worry that interferes with their daily lives and reduces their quality of life.1,2 In the United States amongst community dwelling adults, the 12-month prevalence is 2.9% and lifetime risk is 9%.2 Females are two times as likely to suffer from GAD as are men, and GAD is most often diagnosed during midlife and rates decline after 60 years of age.3 In addition, those
Etiology Although the exact cause of GAD remain uncertain, several potential causes have been identified, including traumatic experiences, genetics, and neurobiological dysfunction. Genetics have been implicated in GAD due to clusters within families. Many of these genetic factors associated with GAD also have significant overlap with other anxiety and mood disorders.2,3 In addition, both altered neurotransmitter activity and physical abnormalities of the brain have been noted in patients with GAD.3 Other risk factors associated with GAD include behavioral inhibition, neuroticism, and avoidance of harmful situations. Although overprotective behavior by parents and a challenging childhood are associated with generalized anxiety disorder, no environmental factors are explicitly implicated GAD.2 Diagnosis According to the 2013 DSM-V diagnostic criteria for GAD, the key diagnostic feature of GAD is excessive worry and anxiety about a variety of events, over at least a 6-month time period
Table 1: DSM-V Diagnostic Criteria for Generalized Anxiety Disorder2 - Significant anxiety and worry about a variety of things, on most days for at least 6 months - The individual must find it hard to control his or her worrying - Anxiety and worry must be associated with at least three of the following (only 1 in children) on most days over the previous 6 months - Restlessness - Fatigue - Difficulty concentrating - Irritability - Muscle tension - Sleep disturbances - Symptoms must cause impairment in important areas of functioning (work, social gatherings) - Symptoms are not related to substance (drug abuse, medications) or other medical conditions - Symptoms are not better explained by another medical disorder Adapted from the American Psychiatric Association: Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition. 32 • Arizona Journal of Pharmacy • Winter 2014
Table 3: Illnesses that may present with anxiety symptoms1,5 Akathisia Anemia Arrhythmia Asthma Chronic Obstructive Pulmonary Disease Congestive Heart Failure Coronary Artery Disease Diabetes Electrolyte Imbalance Epilepsy Hypoglycemia Hypoxia Lung embolism Neoplasms Pain Porphyria Stroke Thyroid Dysfunction Valve dysfunction Vertigo
Table 4: Medications that may cause anxiety1,5 Anticonvulsants Antidepressants Antihypertensives Antibiotics Bronchodilators Caffeine Corticosteroids Dopa Agonists Herbals Illicit Substances Nonsteroidal Antiinflammatory Agents Stimulants Sympathomimetics Thyroid Hormone Toxicity (digoxin, antihistamine, anticholinergic)
Continuing Education (continued from page 32) (Table 1). These symptoms interfere with daily activities and reduce quality of life. Patients must also present with a minimum of three physical symptoms including restlessness, fatigue, irritability, difficulty concentrating, muscle tension, or poor sleep (Table 2). Symptoms must not be related to substance abuse, other medical illnesses, or better explained by another psychological condition.2 The Hamilton Anxiety Scale (HAM-A) is considered the gold-standard for assessing the efficacy of pharmacotherapy in GAD. It consists of a 14 questions assessing the physical symptoms of GAD and effectiveness of treatment is determined by improvement (reduction) of the HAM-A scores throughout the treatment time period. The Penn State Worry Questionnaire assesses symptoms of extreme and uncontrollable worry; it is the tool most often used to assess effects of psychotherapy in GAD.4 Differential Diagnosis Prior to diagnosis of GAD, it is crucial to rule out other medical issues with similar symptoms, including substance induced anxiety disorder, social anxiety disorder, obsessive-compulsive disorder, post-traumatic stress disorder, adjustment disorders, or other psychological disorders (bipolar, depression, psychotic disorders).2 Other medical conditions with symptoms similar to generalized anxiety disorder need to be investigated. If patient’s symptoms are due to another illness (Table 3), the appropriate diagnosis is “anxiety disorder due to another medical condition.” There are several medications that can induce anxiety (Table 4) and lead to a “medication-induced anxiety disorder.”1,2,5 Treatment Treatment goals focus on improving quality of life by reducing severity and duration of symptoms. These goals can be accomplished by nonpharmacological means (including psychotherapy and cognitive behavioral therapy) or pharmacological treatment options. Long term goals of treatment include remission and prevention of recurrent episodes while managing other comorbid conditions.5,6 Treatment may include pharmacologic therapy alone, psychotherapy alone, or a combination of the two, based upon severity of symptoms and other comorbid conditions. Psychotherapy alone and
pharmacologic therapy alone have a similar efficacy in resolving GAD, but the majority of patients will require some form of psychotherapy (with or without pharmacotherapy) to resolve symptoms of GAD.5 Nonpharmacological Treatment Options Psychodynamic psychotherapy, mindfulness-based therapy, and cognitive behavioral therapy can be used in the treatment of GAD. Psychodynamic psychotherapy is typically a short term treatment option that has rarely been studied and showed varied results in two randomized trials.3 Mindfulnessbased therapy (MBT) is an alternative to other psychotherapy options that may reduce anxiety symptoms.1 Of the nonpharmacological treatment options, cognitive behavioral therapy has the most evidence of efficacy.1,3 Cognitive Behavioral Therapy Cognitive behavioral therapy (CBT) has a wide variety of components including cognitive strategies (examining causes behind worry), muscle relaxation, problem solving strategies, and psychoeducation (education regarding the condition and its treatment). In addition the provider must develop a strong relationship with the patient and assess the patients entire life and not just the anxiety symptoms.3 Special training is necessary to provide the many components CBT encompasses, therefore it is not widely available. CBT requires patients to attend weekly sessions over at least 12 weeks which can be difficult for patients due to the availability, cost and time commitment, but does avoid the potential adverse effects of pharmacotherapy.5,7 Web based approaches to CBT are currently being investigated as a measure to increase the number of patients with access to CBT.7 A 2013 article, by Wetherell and colleagues, assessed the impact of augmenting pharmacotherapy with CBT in adults with GAD. The study randomized 73 patients into one of four groups following completion of a 12 week treatment with escitalopram. Group 1 received 16 weeks of escitalopram plus CBT, then maintenance escitalopram for 28 weeks. Group 2 received escitalopram alone for 16 weeks and then maintenance escitalopram. The third group received escitalopram and CBT with a placebo during the maintenance period and the
fourth group received escitalopram alone with a placebo during the maintenance period. The study found that while the continued SSRI prevented relapse, many subjects were able to achieve remission on CBT alone, without long-term medication.4 Pharmacotherapy There are a number of medications that are available to treat GAD. Firstline pharmacotherapy includes selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs). Although the efficacy is expected to be similar amongst SSRIs and SNRIs, only some of these agents have FDA approval and no single agent has been identified as superior (Table 5). Additional agents used in the treatment of GAD include benzodiazepines, buspirone, pregabalin, and hydroxyzine.8 Selective Serotonin Reuptake Inhibitors The SSRIs have emerged as the firstline treatment agent for GAD primarily due to their tolerability and safety profile.9 These agents can be used for a long period of time without concern for abuse or tolerance. Although treatment efficacy is similar amongst the entire class of SSRI antidepressants, only paroxetine and escitalopram have been approved by the United States Food and Drug Administration (FDA) for the treatment of GAD.8 Although not FDA approved, sertraline has also shown efficacy and is frequently used.3 SSRIs as a class are typically well tolerated, although patients may experience adverse effects including stomach upset, agitation, somnolence, weight gain, and worsened anxiety upon initiation.3,6 These are important counseling points for patients as they may lead to noncompliance or discontinued use of the agent because patients may feel the medication exacerbated his or her anxiety symptoms.8 Patients need to be educated that anxiolytic effects typically begin 2-4 weeks after initiation.3 Although these adverse effects are similar among the agents within the class of SSRIs, the frequency of adverse effects is dependent on the specific agent used.1 To reduce the incidence of adverse effects utilize low starting doses and titrate slowly.10 Patients should also be counseled about the importance of not suddenly discontinuing a SSRI due to the potential
Winter 2014 • Arizona Journal of Pharmacy • 33
Continuing Education (continued from page 33) Table 5: Antidepressants Commonly Used in GAD23 Starting dose (mg/day) Escitalopram
5 – 10
Minimal Target Dose (mg/day) 10
Maximum Dose (mg/day)
Paroxetine-IR
10 – 20
20
50
Sertraline (not FDA approved) Duloxetine
25
50
200
30
60
120
Venlafaxine-ER
37.5 – 75
75
225
Imipramine (second line agent)
25 (HS)
100
300
for a discontinuation syndrome, including insomnia and flu-like symptoms.11 The discontinuation syndrome is more common in agents with a shorter halflife. To prevent these symptoms, doses should be slowly tapered down over several weeks.8 Another option to prevent discontinuation syndrome includes changing the current agent to an agent with a long half-life, like fluoxetine.10 Serotonin-Norepinephrine Reuptake Inhibitors Both duloxetine and venlafaxine-ER have FDA approval for the treatment of GAD and have similar efficacy to the SSRIs. The SNRIs have similar side effects as the SSRIs, but may additionally cause orthostatic hypotension, elevated blood pressure, sweating and urinary retention. They carry the same risk for potential withdrawal symptoms and the dose must be slowly titrated to prevent a discontinuation syndrome.6 In 2007, Koponen and Allgulander looked at the efficacy of duloxetine 60 mg/ day and duloxetine 120 mg/day compared to placebo in treating GAD. The study found that both duloxetine groups (60 mg/ day and 120 mg/day) had significantly greater response rates (58% and 56% respectively) compared to placebo (31%). Sustained improvement rates were significantly greater in both duloxetine groups when compared to placebo and there were no differences in any efficacy outcomes between the two doses. Study subjects experienced expected SNRI side effects, including nausea, dry mouth, and fatigue.12,13 Previous studies showed clinically insignificant elevations in liver function tests in patients on duloxetine; this has led to the avoidance of duloxetine
20
Table 6: Pharmacokinetics of Anxiolytic Benzodiazepines5,31 Agent
Lipophilicity
Half Life (hrs)
Metabolism
Active Metabolite
Protein Binding
Lorazepam
Low
10-20
Conjugation
No
Low
Oxazepam
Low
5-20
Conjugation
No
High
Clonazepam
Medium
30-40
Nitroreduction
No
Low
Chlordiazepoxide
Medium
5-30
Oxidation
Yes
High
Clorazepate
High
Prodrug
Oxidation
Yes
High
Diazepam
High
20-80
Oxidation
Yes
High
Alprazolam
High
12-15
Oxidation
No
Low
in those patients with liver impairment.12 A 2012 study by Zhang and colleagues examined the pharmacoeconomics of treating GAD with citalopram or venlafaxine in 100 patients. The study found the treatment costs of venlafaxine to be greater than those of the citalopram group, but the treatment efficacy of the venlafaxine group was superior to the citalopram group (94% of venlafaxine subjects vs 70% citalopram subjects). Due to the increased efficacy rates of this small study, it appears that venlafaxine is more cost effective than citalopram although there is higher cost of medication.14 Benzodiazepines Benzodiazepines have been used for many years in the treatment of anxiety disorders due to their rapid effects on the physical symptoms of anxiety; however, they have many adverse effects including falls, memory loss, confusion, sedation, and impaired dexterity.6,9 Another severe adverse effect of this medication class is the withdrawal syndrome that occurs following discontinuation. These symptoms may persist even when the medication is slowly tapered off. Benzodiazepines also have an abuse potential that is not present with antidepressants used in treating GAD.6 Benzodiazepines provide relief from physical symptoms of anxiety, but not from psychological symptoms.9 For those patients requiring treatment with a benzodiazepine, relief of anxiety is believed to be a class effect, although certain agents have been studied more than others.9 There are seven anxiolytic benzodiazepines and the specific agent should be selected based upon the pharmacokinetic profiles and the patient’s
34 • Arizona Journal of Pharmacy • Winter 2014
additional comorbidities (Table 6).5 Due to the severe adverse effects, abuse potential, and difficulty of discontinuation, benzodiazepines are only recommended for short-term use in treating acute anxiety. These agents may prove beneficial in relieving acute symptoms until a SSRI or SNRI reaches therapeutic effects.6,10 This approach helps reduce the adverse effects seen when initiating an antidepressant. Following adequate relief with the antidepressant, benzodiazepines should be tapered to reduce withdrawal symptoms.10 The 2011 National Institute for Health and Care Excellence (NICE) Generalised anxiety disorder and panic disorder (with or without agoraphobia) in adults clinical guideline states “do not offer a benzodiazepine for the treatment of GAD in primary or secondary care except as a short-term measure during crises.”15 A 2006 article by Rapaport and colleagues, studied combination therapy with alprazolam and a SSRI compared to a SSRI alone. The primary endpoint was time to response and there was no significant difference between the two groups. The combination group did experience a more rapid improvement in insomnia, but had a greater incidence of side effects, including fatigue, somnolence, and dry mouth.16 Other treatment options Additional Antidepressants In addition to the SSRIs and SNRIs, other antidepressants have been considered in the treatment of GAD; however, these trials have historically been very small studies. Due to the large volume of evidence supporting the use of SSRIs and SNRIs, other antidepressants are typically used in those patients
Continuing Education (continued from page 34) refractory to first-line agents or unable to tolerate the first-line agents.10 In 1993, a study was performed that examined the efficacy of monotherapy with diazepam, imipramine, and trazodone compared to placebo in GAD, in a small (N=230), 8-week, randomized controlled trial. All agents were superior to placebo, and both imipramine and trazodone showed similar efficacy to diazepam by the end of the study. The efficacy of imipramine was accompanied by increased rates of anticholinergic adverse effects (sedation, constipation), sexual dysfunction, and risk of toxicity.7,10 Due to these side effects, imipramine is typically only considered in patients who have failed first-line treatment with a SSRI or SNRI. As this is the only study examining the efficacy of trazodone in GAD, larger trials are needed to confirm these results.10 A small (N=24) randomized trial found bupropion XR to be comparable to escitalopram; however, there have not been any larger studies to confirm this finding.7 At this time there are no randomized trials supporting mirtazapine or nefazodone in GAD.10 Anticonvulsants Pregabalin has been approved for the treatment of GAD in Europe; however, the FDA has not approved it in the United States. Some advantages of pregabalin include the rapid onset of action, with effects beginning on the 4th day, and it appears to be fairly well tolerated. Adverse effects associated with pregabalin include irritability, dizziness, sexual dysfunction, weight gain, and GI upset.3,17 Lack of concentration and drowsiness are likely especially upon initiation of pregabalin, although patients may develop tolerance to these effects.3 Pregabalin has been studied as a treatment option in GAD in numerous randomized controlled studies. In 2010, Lydiard and colleagues examined data from six double-blind, controlled studies that looked at pregabalin in the short-term treatment of GAD. Doses ranged from 150 mg daily to 600 mg daily in divided doses. The results of this review found pregabalin to be effective in treating both somatic and psychological symptoms of GAD; however, the beneficial effects plateaued at doses above 300 mg daily.17 A 2012 study looked at the efficacy of pregabalin as an adjunctive agent in patients who had not responded to first-
line treatment options. The study found that the mean change in HAM-A scores was significantly greater in those patients treated with pregabalin. Pregabalin was relatively well tolerated with a low discontinuation rate of 4.4% compared with 2.3% in the placebo group.18 Gabapentin and valproate, have minimal evidence of efficacy in GAD and require further research prior to use in GAD. Tiagabine has mixed evidence in treatment of GAD and is not recommended due to lack of improvement in anxiety symptoms when compared to placebo, in a 10-week randomized trial.17 Antipsychotics Although atypical antipsychotics do not have an FDA-approved indication for the treatment of GAD, many prescribers report off label use of these agents. Some prescribers cite the “antineurotic” properties of antipsychotics and improved symptom relief as reasons for this off-label use. Other prescribers view second generation antipsychotics as less problematic than benzodiazepines.19 A 2011 article by Comer and colleagues examined results from the 1996-2007 National Ambulatory Medical Care Survey to assess trends related to antipsychotic use in anxiety disorders. The study found an increase in antipsychotic prescriptions in patients with an anxiety disorder (and no other comorbid conditions with an FDA indication for an antipsychotic medication) from 1996-1999 (6.9%) to 2004-2007 (14.5%).20 Of the atypical antipsychotics, quetiapine has the most evidence supporting its use in GAD. A large (N=873), double-blind, placebo-controlled trial compared monotherapy with quetiapine XR 50 mg, quetiapine XR 150 mg, paroxetine 20 mg, and placebo. After 8 weeks, only quetiapine XR 150 mg and paroxetine 20 mg achieved remission. Other studies looking at quetiapine had mixed results.17 Other antipsychotics have shown mixed results in augmenting GAD treatment, and most studies had only small sample sizes. A small study comparing olanzapine to placebo in augmenting GAD found more responders in the olanzapine group; however, these subjects had more weight gain due to the metabolic adverse effects of the antipsychotic. Two randomized studies looking at risperidone augmentation were unable to
find a statistically significant difference in response rates compared to placebo.10 The questionable efficacy of antipsychotics for GAD treatment may not outweigh the number of adverse effects associated with this class including metabolic side effects (elevated blood glucose, dyslipidemia, and weight gain), fatigue, dry mouth, dizziness, and headache.1,3,17 Due to the risk of adverse effects and mixed results from studies, the 2011 NICE guidelines state “do not offer an antipsychotic for the treatment of GAD in primary care.”15 It is apparent that more evidence is needed regarding the safety and efficacy of antipsychotics in GAD, prior to routine use of these agents.21 Hydroxyzine The antihistamine, hydroxyzine, has shown evidence in relieving symptoms of GAD in three randomized controlled trials at a dose of 50 mg daily. The most common adverse effect is drowsiness, especially upon initiation.17 Advantages of this medication include a rapid onset of action and no risk for dependence. Due to the safety and efficacy of this agent within these studies, hydroxyzine is an acceptable agent in treating GAD.3 Buspirone Buspirone works as a nonbenzodiazepine anxiolytic and has shown efficacy in GAD. Unlike the benzodiazepines, it takes 2-3 weeks to see the effects of this agent and does not cause sedation, tolerance, dependence, or withdrawal symptoms. Buspirone has more effects on the psychological symptoms of GAD than the somatic symptoms.22 The side effects of buspirone are relatively mild, with some GI upset and dizziness.9 Buspirone has been studied in at least 15 randomized controlled trials. At least 10 of these studies found buspirone to be more effective than placebo, although it was never found to be more effective than a benzodiazepine. Due to its efficacy, buspirone is a treatment option in those patients with a history of substance abuse or in those unable to tolerate benzodiazepines and/or a SSRI or SNRI.9 Dealing with a Partial Response or No Response Patients should be evaluated for efficacy after 4-6 weeks of treatment, although it may take up to 12 weeks for compete
Winter 2014 • Arizona Journal of Pharmacy • 35
Continuing Education (continued from page 35) resolution of symptoms.23 For those patients who fail to respond to treatment with a first-line antidepressant, the next step includes augmenting the current therapy or switching to another first-line agent.7 A partial response is defined as a 25-49% reduction in symptoms from baseline and non-response is defined as less than a 25% reduction in symptoms from baseline.23 Those patients who have failed at least two antidepressants from different classes may be labeled as treatment resistant (although this definition varies throughout the literature) and should be referred to a mental health specialist.23,24 If a patient has a partial response to the antidepressant at the 4-6 week follow up, providers can choose to titrate the dose up (if not at the full treatment dose), augment dose with another agent, or select a different first-line agent. Treatment options for augmentation include hydroxyzine, buspirone, or pregabalin.10,23 Antipsychotic agents may be beneficial in those patients with other psychological comorbidities or treatment resistant GAD.24 Changing to a new first-line antidepressant is another treatment option for a partial response. This change can be made within the same class (SSRI to SSRI) or to another class (SSRI to SNRI).23 If the initial treatment does not work, patients may also try a combination of pharmacotherapy with psychotherapy or CBT for improved outcomes.11 Patients who have no response to the first antidepressant should change to a different first-line antidepressant, either in the same class (SSRI to SSRI) or in a new class (SSRI to SNRI). A second SSRI may be effective in up to 50% of patients that failed an initial SSRI. There is also evidence that a SNRI may have effects even in patients who have failed several agents. Patients who have failed two SSRIs should be trialed on a SNRI prior to selecting a benzodiazepine for treatment. If a patient fails both a SSRI and a SNRI, imipramine is an appropriate option.23 Either pregabalin or hydroxyzine may be appropriate to augment treatments due to the minimal adverse effects of these agents for patients who have not responded to first-line therapy.17 Discontinuing Pharmacotherapy Pharmacotherapy should be continued for at least 12 months in order to improve remission rates and reduce relapse rates
in this chronic disorder. Patients should be counseled to continue the medication for at least a year even if they have relief of anxiety symptoms. They also need to be educated about the importance of reporting side effects to providers, as these adverse effects can lead to noncompliance and treatment failure.23,25 Special Populations Elderly Managing GAD in elderly patients is more complicated due to the risk of drug interaction, comorbidities, metabolic changes, and sensitivity to adverse effects.23 A number of agents used in the treatment of GAD are on the Beers criteria of medications potentially inappropriate in the elderly.26 The Beers criteria identifies benzodiazepines as agents that should be avoided in the elderly population, except in “severe generalized anxiety disorder” due to the risk of cognitive impairment and falls.26 Of concern in elderly patients is the fact that Medicare Part D began covering benzodiazepines on January 1, 2013. These agents had been previously excluded from Medicare Part D by the Medicare Modernization Act in 2006 due to the risk of adverse events in the elderly.27 As patients may be restarting these agents, it is crucial patients receive counseling on the risks of these agents, including impaired cognition, increased risk of falls, dizziness, and dependence.3 Anticholinergic agents (TCAs, hydroxyzine, some antipsychotics) should also be avoided due to an increased risk of side effects. Antidepressants and antipsychotics can cause hyponatremia or syndrome of inappropriate antidiuretic hormone secretion, as such, these agents should be used with caution.26 Another challenge in the elderly population is the lack of studies evaluating this age group. Citalopram has been studied in the geriatric population; it was shown to be effective and the most common side effect was sedation. A pooled analysis of velafaxine ER showed similar efficacy and tolerability in patients over 60 years old and younger adults. Duloxetine was effective in reducing symptoms in a post hoc pooled analysis; however, it had a high rate of side effects and discontinuations. Pregabalin (variable dose 150-600 mg/day) was effective in an 8-week randomized trial in the geriatric population.23
36 • Arizona Journal of Pharmacy • Winter 2014
Children and Adolescents According to the British Association for Psychopharmacology, psychotherapy is the first-line treatment in adolescents, with pharmacotherapy held in reserve for those who failed psychotherapy. If pharmacotherapy is needed, sertraline, fluoxetine, fluvoxamine, and venlafaxine ER are effective in treating children and youth with GAD. The SSRIs were well tolerated in three studies. Venlafaxine ER resulted in increased blood pressure and heart rate and weight loss in this population, which could become problematic when used long-term. Providers must carefully dose adjust and monitor for adverse effects and suicidal ideation in this population.23 Pregnancy Caution must be advised in treating pregnant patients suffering from GAD, since the agents used in GAD rapidly cross the placenta. As such, it is critical that the benefits and risks of treatment be assessed on an individual basis. Psychotherapy and CBT should be considered first-line treatment in pregnant women. Medications should only be initiated if the risk of depression for the mother outweighs the potential risk from medications to the fetus because there is a lack of information regarding the safety of many agents in this population. One concern is the risk for withdrawal upon delivery; if patients require medication, this risk can be minimized by using lower doses around delivery.28 Benzodiazpeines should be avoided due to the risk for withdrawal syndrome upon delivery. These agents have also been associated with cleft lip when used during the first trimester.28 A 2013 review article examined the risk of birth defects in the first trimester of over 3200 women who had used a SSRI or TCA. The article found that there was no statistically significant differences in the rate of congenital defects in those women who had used an antidepressant compared to those who had not.29 Paroxetine had a small absolute increased risk of cardiac deaths in newborns exposed during their first trimester and should be avoided if possible during this period. Mirtazapine, burpropion, venlafaxine, duloxetine, and phenelzine have very limited data in pregnancy and caution should be exercised if these patients are required in pregnancy.30
Continuing Education (continued from page 36) Conclusion Generalized anxiety disorder is a common condition and proper treatment allows for improved quality of life. Appropriate agents and dose titration are key in achieving relief of symptoms and remission. Pharmacists can work with providers to ensure appropriate titration and tapering of antidepressants to reduce side effects and withdrawal symptoms associated with these agents. In addition, pharmacists are in a key position to educate patients regarding potential side effects and the amount of time it will take to see efficacy. These counseling points can improve patient compliance and outcomes. References 1. Parmentier H, Garcia-Campayo J, Prieto R. Comprehensive review of generalized anxiety disorder in primary care in Europe. Current Medical Research and Opinion. 2013;29(4):355-367. 2. American Psychiatric Association: Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition. Arlington, VA, American Psychiatric Association, 2013. Web. [access date: 1 June 2013]. dsm.psychiatryonline.org 3.Bandelow B, Boerner RJ, Kasper S, et al. The diagnosis and treatment of generalized anxiety disorder. Dtsch Arztebl Int. 2013;110(17):300-310. 4. Wetherell JL, Petkus AJ, White KS, et al. Antidepressant medication augmented with cognitivebehavioral therapy for generalized anxiety disorder in older adults. Am J Psychiatry. 2013; 170(7):782-9. 5. Melton ST, Kirkwood CK. Chapter 79. Anxiety Disorders I: Generalized Anxiety, Panic, and Social Anxiety Disorders. In: DiPiro JT, Talbert RL, Yee GC, Matzke GR, Wells BG, Posey LM, eds. Pharmacotherapy: A Pathophysiologic Approach. 8th ed. New York: McGraw-Hill; 2011. http://0-www. accesspharmacy.com.millennium.midwestern.edu/ content.aspx?aID=7989670. Accessed July 2, 2013. 6. Davidson JR, Feltner DE, Dugar A. Management of generalized anxiety disorder in primary care: identifying the challenges and unmet needs. Prim Care Companion J Clin Psychiatry. 2010;12(2):PCC.09r00772. 7. Lanouette NM, Stein MB. Advances in the management of treatment-resistant anxiety disorders. The Journal of Lifelong Learning in Psychiatry. 2010;3(4):501-524. 8. Kavan MG, Elsasser GN, Barone EJ. Generalized anxiety disorder: practical assessment and management. Am Fam Physician. 2009;79(9):785791. 9. Hoge EA, Oppenheimer JE, Simon NM. Generalized anxiety disorder. The Journal of Lifelong Learning in Psychiatry. 2004(2):346-359. 10. Ravindran LN, Stein MB. The pharmacologic treatment of anxiety disorders: a review of progress. J Clin Psychiatry. 2010;71(7):839-854. 11. Baldwin DS, Anderson IM, Nutt DJ, et al. Evidence-based guidelines for the pharmacological treatment of anxiety disorders: Recommendations from the British Association for Psychopharmacology. Journal of Psychopharmacology. 2005;19(6):567-596. 12. Khan AY, Macaluso M. Duloxetine for the treatment of generalized anxiety disorder: a review.
Neuropsychiatric Disease and Treatment. 2009;5:2331. 13. Koponen H, Allgulander C. Efficacy of duloxetine for the treatment of generalized anxiety disorder: implications for primary care physicians. Prim Care Companion J Clin Psychiatry. 2007;9(2):100-107. 14. Zhang J, Xu H, Chen Z. Pharmacoeconomic evaluation of venlafaxine compared with citalopram in generalized anxiety disorder. Experimental and Therapeutic Medicine. 2013; 5: 840-844. 15. National Institute for Health and Clinical Excellence. Generalised anxiety disorder and panic disorder (with or without agoraphobia) in adults. National Institute for Health and Clinical Excellence. 2011. http://www.nice.org.uk/nicemedia/ live/13314/52601/52601.pdf. Accessed July 2, 2013. 16. Rapaport MH, Skarky SB, Katzelnick DJ, et al. Time to response in generalized anxiety disorder in a naturalistic setting: combination therapy with alprazolam orally disintegrating tablets and serotonin reuptake inhibitors compared to serotonin reuptake inhibitors alone. Psychiatry (Edgmont). 2006;3(12):50-59. 17. Huh J, Goebert D, Takeshita J, et al. Treatment of generalized anxiety disorder: a comprehensive review of the literature for psychopharmacologic alternatives to newer antidepressants and benzodiazepines. Prim Care Companion CNS Disord. 2011;13(2):PCC.08r00709. 18. Rickels K, Shiovitz TM, Ramey TS, et al. Adjunctive therapy with pregabalin in generalized anxiety disorder patients with partial response to SSRI or SNRI treatment. Int Clin Psychopharmacol. 2012;27:142-250. 19. Wolfe J. Antipsychotics increasingly prescribed for anxiety. Psychiatric News, Sep 2011; 46 (17):2027. 20. Comer JS, Mojtabai R, Olfson M. National trends in the antipsychotic treatment of psychiatric outpatients with anxiety disorders. Am J Psychiatry. 2011;168:1057-1065. 21. Brier A. Anxiety disorders and antipsychotic drugs: a pressing need for more research. Am J Psychiatry. 2011;168(10):1012-1014. 22. Cassano GB, Rossi NB, Pini S. Psychopharmacology of anxiety disorders. Dialogues Clin Neurosci. I2002;4:271-285. 23. Davidson JR, Zhang W, Connor KM, et al. A psychopharmacological treatment algorithm for generalized anxiety disorder (GAD). J Psychopharmacol. 2010;24(1):3–26. 24. Katzman MA. Current considerations in the treatment of generalized anxiety disorder. CNS Drugs. 2009;23(2):103-120.
25. Arehart-Treichel J. Extended GAD treatment keeps relapse rates low. Psychiatric News, Feb 2011; 46 (3):24-24. 26. The American Geriatrics Society 2012 Beers Criteria Update Expert Panel (2012), American Geriatrics Society Updated Beers Criteria for Potentially Inappropriate Medication Use in Older Adults. Journal of the American Geriatrics Society, 60: 616–631. 27. Ong MK, Zhang L, Xu H, et al. Medicare Part D benzodiazepine exclusion and use of psychotropic medication by patients with new anxiety disorders. Psychiatric Services. 2012;63(7):637-642. 28. Rubinchik SM, Kablinger AS, Gardner LS. Medications for panic disorder and generalized anxiety disorder during pregnancy. Prim Care Companion J Clin Psychiatry. 2005;7:100-105. 29. Vasilakis-Scaramozza C, Aschengrau A, Cabral H, Jick SS. Antidepressant use during early pregnancy and the risk of congenital anomalies. Pharmacotherapy. 2013;33(7):693-700. 30. Payne JL, Meltzer-Brody S. Antidepressant use during pregnancy: Current controversies and treatment strategies. Clin Obstet Gynecol. 2009;52(3):469-482. 31. Lexi-Comp, Inc. (Lexi-DrugsTM). Lexi-Comp, Inc.; June 2013.
ACPE UAN#0100-0000-13-070-H01-P
An additional continuing pharmacy education homestudy article titled Transitions of Care is available on the AzPA website in the AJP Archives. Member login is required. Free CPE credit from home study articles published in the Arizona Journal of Pharmacy is a member benefit for AzPA Members. Not a member? Visit the AzPA website and join today!
GET THE FACTS! 1 IN 7 TEENS AND YOUNG ADULTS WHO GET BACTERIAL MENINGITIS WILL DIE
IMMUNIZE AGAINST MENINGITIS http://www.t2x.me/meningitis Winter 2014 • Arizona Journal of Pharmacy • 37
Continuing Education Quiz Questions
Considerations in the Management of Generalized Anxiety Disorder ACPE UAN#0100-0000-13-070-H01-P 1. Presentation of GAD includes all of the following, EXCEPT: a. Significant worry or anxiety for at least 1 month b. Worry or anxiety about a variety of issues or events that interferes with quality of life c. Physical symptoms including difficulty concentrating, sleep issues, and fatigue d. All of the above are associated with the presentation of GAD 2. Which of the following medications has NOT been implicated in inducing anxiety symptoms? a. Albuterol b. Hydroxyzine c. Levothyroxine d. Sertraline 3. Which of the following nonpharmacological treatment options is the most efficacious? a. Cognitive behavioral therapy b. Diet and exercise c. Mindfulness-based therapy d. Psychodynamic psychotherapy 4. Use the following information for Questions 4 and 5. JR is a 42 year old male who has just been diagnosed with GAD after 6 months of worry and anxiety about his situation at work. He has decided to opt for pharmacotherapy instead on nonpharmacolgical treatment at this time. He has a history of alcohol and other substance abuse. What would be the most appropriate first-line treatment agent for JR? a. Diazepam b. Hydroxyzine c. Imipramine d. Sertraline 5. a. b. c.
How long should JR be continued on pharmacotherapy? At least 12 months Lifelong treatment will be necessary Until symptoms resolve
ANSWER SHEET AND EVALUATION FOR THIS HOME-STUDY ACTIVITY ARE ON PAGE 39.
38 • Arizona Journal of Pharmacy • Winter 2014
6. SC presents to your pharmacy with a new prescription for escitalopram. She tells you that she has just been diagnosed with GAD. Which of the following would be the most appropriate counseling points for SC? a. Common side effects include increased risk of falls and memory loss b. This medication may take a couple weeks for anxiolytic effects c. This medication should not be discontinued abruptly d. A and B e. B and C f. All of the above 7. Which of the following agents should avoided in patients with hepatic insufficiency? a. Bupropion b. Duloxetine c. Sertraline d. Venlafaxine 8. Which of the following agents has/have shown efficacy in augmenting treatment of GAD? a. Mirtazapine b. Pregabalin c. Risperidone d. A and B e. All of the above 9. Which of the following statements regarding benzodiazepines is most correct? a. Benzodiazepines should be avoided in pregnancy b. Benzodiazepines should be slowly tapered to prevent withdrawal symptoms c. Benzodiazepines provide relief of psychological and physical symptoms of anxiety d. A and B e. All of the above 10. Which of the following would be most appropriate in a patient who had no response to sertraline as the initial agent in treating GAD? a. Augment with an antipsychotic b. Change to a benzodiazepine c. Change to another SSRI or a SNRI d. Refer to a mental health specialist
Continuing Education Answer Sheet
I.
Considerations in the Management of Generalized Anxiety Disorder ACPE UAN#0100-0000-13-070-H01-P
Activity accredited date: 01/15/2014 Expiration date: 01/15/2017. This activity is accredited for 1.0 hours of CPE credit (CEUs 0.10) 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.
CE Assessment Answers - Please circle your answers (one answer per question.) 1. a. b. c. d. 6. a. 2. a. b. c. d. 7. a. 3. a. b. c. d. 8. a. 4. a. b. c. d. 9. a.
Questions on page 38. b. c. d. e. b. c. d. b. c. d. e. b. c. d. e.
5.
b.
a.
b.
c.
10. a.
c.
f.b.
d.
ACTIVITY EVALUATION – Must be completed to receive credit. 1. The activity met the stated learning objectives. (Full list of learning objectives in article.)
AGREE
DISAGREE
2. Please rate the activity based on the following (please circle one): • Overall evaluation of the article content: • Relevance to pharmacy practice • Value of the content
Poor Poor Poor
2 2 2
3. The information presented (check all that apply): Reinforce my current practice/treatment habits Provided new ideas or information I expect to use
1 1 1
3 3 3
4 4 4
5 5 5
Excellent Excellent Excellent
Will improve my practice/patient outcomes Adds to my knowledge
4. Will the information presented cause you to make any changes to your style or method?
Yes
5. Will the information presented cause you to make any changes in your practice?
Yes
.
6. How committed are you to making these changes?
No No
Not committed
7. Do you feel future activities on this subject matter are necessary and/or important?
1
2
3
Yes
4
5 Very committed
No
Transitions of Care ACPE UAN#0100-0000-13-069-H04-P (Article available for members only on AzPA website. See page 37 for details.) Activity accredited date: 01/15/2014 Expiration date:01/15/2017. This activity is accredited for 1.0 hours of CPE credit (CEUs 0.10) 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.
II.
CE Assessment Answers - Please circle your answers (one answer per question.) 1. a. b. c. d. 6. a. 2. a. b. c. d. 7. a. 3. a. b. c. d. 8. a. 4. a. b. c. d. 9. a. 5.
a.
b.
c.
d.
10.
a.
Questions with online home-study article. b. c. d. b. c. d. b. c. d. b. c. d. b.
c.
d.
ACTIVITY EVALUATION – Must be completed to receive credit. 1. The activity met the stated learning objectives. (Full list of learning objectives in article.)
AGREE
DISAGREE
2. Please rate the activity based on the following (please circle one): • Overall evaluation of the article content: • Relevance to pharmacy practice • Value of the content
Poor Poor Poor
2 2 2
3. The information presented (check all that apply): Reinforce my current practice/treatment habits Provided new ideas or information I expect to use
1 1 1
3 3 3
4 4 4
5 5 5
Excellent Excellent Excellent
Will improve my practice/patient outcomes Adds to my knowledge
4. Will the information presented cause you to make any changes to your style or method?
Yes
No
5. Will the information presented cause you to make any changes in your practice?
Yes
No
.
6. How committed are you to making these changes?
Not committed
7. Do you feel future activities on this subject matter are necessary and/or important?
Yes
1
2
3
4
5 Very committed
No
PARTICIPANT INFORMATION: Name __________________________________________________________ Address ________________________________________________________
Send this page to: AzPA, 1845 E. Southern Ave., Tempe, AZ 85282
Email ________________________________________________________
City, State, Zip ___________________________________________________ Birthdate (MM/DD only) ______________ NABP e-Profile ID# ________________ Continuing education home-study activities are a benefit to AzPA members. Non-members of AzPA must enclose $25.00 per activity. Make check payable to AzPA. As part of our ongoing quality-improvement effort, may we contact you to participate in a survey to assess the impact of our continuing pharmacy educational activities? Yes No
This activity was developed by the Arizona Pharmacy Association for pharmacists as a knowledge-based learning activity. The Arizona Pharmacy Association is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.
• Pharmacists Mutual Insurance Company • Pharmacists Life Insurance Company • Pro Advantage Services®, Inc.
let our experts
d/b/a Pharmacists Insurance Agency (in California) CA License No. 0G22035
do the math
Now more than ever, pharmacists are learning just how important it is to have not only proper insurance coverage, but the right amount of insurance. We understand the risks involved in operating a pharmacy practice and have coverage designed to ensure that you and your business are protected. We even provide policies specifically designed for practices that offer specialty services such as compounding or home medical equipment. Trust the experts - our representatives can help you determine the right coverage for you. We offer products to meet all your needs; everything from business and personal insurance to life and investments. We’re proud to be your single source for insurance protection.
Ryan Goodrich
800.247.5930 ext. 7133 480.332.5656
800.247.5930 www.phmic.com
Find us on Social Media:
Not licensed to sell all products in all states.
2013 Recipients of the “Bowl of Hygeia” Award
Charles D. Sands III Alabama
Martie Lamont Alaska
Kathryn Labbe Arizona
Karrol Fowlkes Arkansas*
Vicki Fowlkes Arkansas*
Helen K Park California
Ronald Kennedy Colorado
Gregory L Hancock Connecticut
David W. Dryden Delaware
Judith Martin Riffee Florida
William Lee Prather Georgia
Selma Yamamoto Hawaii
Mark Johnston Idaho
Garry Moreland Illinois
Patrick Cashen Indiana
Bernard Cremers Iowa
Leland Hanson Kansas
J Leon Claywell Kentucky
Douglas Boudreaux Louisiana
Paul Chace Maine
Angelo C. Voxakis Maryland
John R Reynolds Massachusetts
Nancy J W Lewis Michigan
Harvey Buchholz Minnesota
Clarence DuBose Mississippi
Kenneth W. Schafermeyer Missouri
Carla Cobb Montana
Scott E Mambourg Nevada
Cheryl A Abel New Hampshire
Eileen Fishman New Jersey
Phil Griego New Mexico
James R. Schiffer New York
Jean Douglas North Carolina
Laurel Haroldson North Dakota
Kenneth S. Alexander Ohio
Eric Winegardner Oklahoma
Wayne Kradjan Oregon
Edward Bechtel Pennsylvania
Daniel Mahiques-Nieves Puerto Rico
Linda A Carver Rhode Island
Linda Reid South Carolina
Ann M Cruse South Dakota
Kenneth Smith Tennessee
Leticia Van de Putte Texas
Dominic DeRose Utah
The “Bowl of Hygeia”
Leo H Ross Virginia
Janet Kusler Washington
Russell Jensen Wisconsin
Timothy Seeley Wyoming
The Bowl of Hygeia award program was originally developed by the A. H. Robins Company to recognize pharmacists across the nation for outstanding service to their communities. Selected through their respective professional pharmacy associations, each of these dedicated individuals has made uniquely personal contributions to a strong, healthy community. We offer our congratulations and thanks for their high example. The American Pharmacists Association Foundation, the National Alliance of State Pharmacy Associations and the state pharmacy associations have assumed responsibility for continuing this prestigious recognition program. All former recipients are encouraged to maintain their linkage to the Bowl of Hygeia by emailing current contact information to awards@naspa.us. The Bowl of Hygeia is on display in the APhA Awards Gallery located in Washington, DC. Boehringer Ingelheim is proud to be the Premier Supporter of the Bowl of Hygeia program. *husband and wife co-recipients
Pre-sort Standard US Postage PAID Phoenix, AZ Permit No. 451
Arizona Pharmacy Association
1845 East Southern Avenue Tempe, Arizona 85282 The Voice of Pharmacy in Arizona.
Going green? Opt for the digital-only version of the Arizona Journal of Pharmacy. Update your member profile or contact the AzPA office.
The Best Always Stands Apart.
Dependable. Professional. Experienced. Our Mission: Consistently Provide Client Experiences Focused On What They Value Most
For more on our supplemental staffing services or to inquire about career opportunities, contact us at
What Makes Us Different?
1.800.Rx relief
• We Provide What The Generic Companies Can’t: VALUE - you get your money’s worth • O ur Pharmacists Are Clinicians: We service all aspects of pharmacy - hospital, home infusion, long term care, managed care, mail order, and community • We Are The Experts: Pharmacy Staffing is ALL WE DO • We Are Experienced: Rx relief has over 60 years of pharmacists experience on our management team • We Are Proven: Rx relief has provided pharmacists and pharmacy technicians for over 30 years • Your Success Is Our Success
Serving the U.S. since 1978
info@rxrelief.com
Rxrelief.com