AJP Spring 2014

Spring 2014 Vol. 6, No. 2

Arizona Journal of Pharmacy

THE OFFICIAL PUBLICATION OF THE ARIZONA PHARMACY ASSOCIATION Brought to you by Pharmacy Network of Arizona

2014 Arizona Pharmacy Association Annual Convention June 26-29, 2014

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S R DE

I V O

R P S A S T S I C A T M R A cHANGing PH

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The Wigwam Resort 300 N. Litchfield Road Litchfield Park, Arizona 85340

ANNUAL CONVENTION HIGHLIGHTS Thursday, June 26, 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.

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.

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.

Separate registration is required for all certificate programs.

9:00 am to 5:00 pm Arizona State Board of Pharmacy Meeting

Friday, June 27, 2014 8:00 am to 4:00 pm Symposium for Residency Preceptor Development Included with convention registration 11:00 am to 1:00 pm AzPA Awards and Leadership Induction Luncheon Included with convention registration 1:15 pm Opening General Session Transforming Patient Care: Paramount Issues and Opportunities in Pharmacy Practice Keynote Speaker: Paul Ambramowitz, Pharm.D., Sc.D. (Hon), ASHP Exec Vice Pres and CEO AzPA Exhibit Hall Dinner Buffer 5:00 pm to 7:00 pm Included with convention registration

CONVENTION HIGHLIGHTS Saturday, June 28, 2014 Transitions

Transitions of Care Workshop 8:00 am to 4:00 pm Included with convention registration

of Care

Student Track 8:00 am to 4:00 pm Exclusively for Student Pharmacists Poster Session and Contest 9:00 am to 2:00 pm Presentations and judging

Your research here!

Arizona Legislative Health Care Update Meet your legislators 2:00 pm to 3:30 pm Casino Night Social Event presented by the AzPA Student Pharmacist Academy 7:30 pm to 9:30 pm

Sunday, June 29, 2014 AzPA Town Hall Meeting 7:45 am to 8:30 am Let your voice be heard!

Prescripton Drug Abuse Panel 8:45 am to 10:00 am Addressing this national epidemic Independent Pharmacy Owners Track All day Sunday Business strategies and law updates 2014 Arizona Pharmacy Law Update 2:30 pm to 4:00 pm with Roger Morris, R.Ph., J.D.

2014 Arizona Pharmacy Association Annual Convention Thursday, June 26 to Sunday, June 29, 2014 Wigwam Resort Litchfield Park, Arizona Full convention registration offers 15.0 contact hours (1.50 CEUs) not including certificate programs.

See page 6 for more information.

Arizona Journal of Pharmacy

THE OFFICIAL PUBLICATION OF THE ARIZONA PHARMACY ASSOCIATION Brought to you by Pharmacy Network of Arizona

Vol. 6, No. 2

Spring 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 28 28 29 29 30 30

Featured Articles

Patient Satisfaction with a Medication Mail-back Program Time Marches On A Look Back - Magneto-Electric Machine Time Capsule Treatment of Acute Acetaminophen Toxicity with Acetylcysteine: Does Route of Administration Make a Difference?

Departments

New Members

Association News PAPA Legislative Update Arizona State Board of Pharmacy Technician Spotlight

Feature Pharmacist • Critical Care with the Emphasis on “Care” Drug Information Question Student Perspective • Pharmacy Day at the State Capitol 2014 • Tradition and Innovation: 47th Annual Southwestern Clinical Pharmacy Seminar Continuing Education

14 18 19 19 20 4 5 9 10 11 12 13 22 27 28 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. Scott Hardy, Pharm.D. Padma Sundareshan, Pharm.D.

Christi Jen, Pharm.D. Nicole Romney, Pharm.D. Radha Manian, Pharm.D.

Spring 2014 • Arizona Journal of Pharmacy • 1

President’s Message

AzPA Fellow Program

Ray Clark, Pharm.D. AzPA President

I am proud to announce a new form of recognition for our pharmacist members, the AzPA Fellow Program! As it is eloquently stated on the application for the program, “Awarding fellowship in the Arizona Pharmacy Association is one means by which the Association fosters and rewards demonstrated excellence in pharmacy. Successful candidates for Fellow status will have made a sustained contribution to the AzPA and will have demonstrated a high level of excellence in pharmacy”. In order to be eligible for this form of recognition an Arizona pharmacist must be a current member of the AzPA and have been a member for at least eight years. The pharmacist must also have presented an AzPA live education program or published an article in the AzPA journal. In addition to these requirements the individual must have served as either an AzPA Committee Chair or an AzPA elected officer.

AzPA Fellow Inaugural Class

Wohleb

Daane

Our first class of AzPA Fellows was introduced at the annual convention last June. The inaugural class includes Jerome Wohleb, Terry Daane, John Musil, Crane Davis, Linda McCoy, Mark Boesen, Kelly Ridgway, Kevin Boesen, and Mike Dietrich. This legendary group of past AzPA leaders has now been granted the privilege of adding the post-nominal letters of FAzPA behind their name for the rest of their lives.

Fellow applications are now available on the AzPA Web site under the “Get Involved” tab. Each application will be reviewed by the FAzPA Selection Committee, which consists of current AzPA Fellows. The committee will then forward their recommendations to the Board of Directors for final approval.

I am pleased to announce that Kelly Ridgway has accepted my appointment as Chair of the FAzPA Selection Committee. Just like the Supreme Court of the United States or the Chair of the Federal Reserve Bank, this is a lifetime appointment. Please join me in congratulating Kelly!

A big thank you goes out to Deborah Marcum from the AzPA staff and Kristyn Straw from the Membership Committee for all of their hard work in rolling out this new program. I was truly impressed with the wonderful job that Kristyn did last year at our annual convention when she inducted our first class of fellows into the program. I would also like to thank University of Arizona Associate Dean Philip Schneider for drawing upon his years of experience with domestic and international pharmacy Fellow programs

to provide the Board of Directors with some fantastic ideas regarding how to initially get the program up and running.

Thank you so much to everyone that participated in last quarter’s contest for the free Harkins movie passes. Congratulations to Roy Snider for winning the contest by being the first member to correctly name at least three activities that the Arizona Pharmacy Foundation (APF) sponsors each year. The APF sponsors AwareRx, a prescription drug abuse and misuse consumer awareness program; Katy’s Kids, a pharmacy-education program for young school children; Pharmacists Assisting Pharmacists of Arizona, a rehabilitation program for pharmacists and pharmacy technicians with substance abuse issues; and the annual AzPA convention. In honor of our first class of AzPA Fellows, one of them is the answer to this quarter’s trivia question. I am awarding two free Harkins movie passes to the first AzPA member that can email me at ray.nelson.clark@gmail.com with the name of the first president of the Arizona Pharmacy Alliance.

The second class of FAzPA honorees will be recognized at the 2014 AzPA Annual Convention at the Wigwam Resort in Litchfield Park, Arizona. In addition to celebrating our peers and reconnecting with colleagues, the Annual Convention Steering Committee has an extraordinary schedule of continuing pharmacy education activities slated. Mark your calendars for June 26th to 29th and plan to attend.

Musil

Davis

McCoy

2 • Arizona Journal of Pharmacy • Spring 2014

M. Boesen

Ridgway

K. Boesen

Dietrich

CEO’s Message

Building Relationships The year has gotten off to a great start.

As an ACPE-accredited provider, AzPA is the Southwest’s premier provider of continuing pharmacy education and our national stature as the voice of pharmacy in Arizona is growing. AzPA has been working hard to establish meaningful relationships that bring new opportunities to our members. Here are a few examples of those efforts: In January, preceptors from across the state gathered at Midwestern University College of Pharmacy – Glendale for a Preceptors Workshop: Ask Not What You Can Do For Your Students, But Ask What Your Students Can Do For You! Establishing Mutually Beneficial Relationships with Your Students and Practice Site. Co-sponsored by Midwestern and the University of Arizona, more than 50 attended the evening presentation facilitated by Mindy Throm, Pharm.D., BCPS. Also in January, as an APhA-licensed partner, AzPA presented the Pharmacist and Patient-Centered Diabetes Care Certificate Program. Facilitated by Betty Louton, Pharm.D., and Grace Akoh-Arrey, Pharm.D., CDE, 74 pharmacists and student pharmacists from Arizona and across the country, including Alaska, Vermont, Wisconsin, Ohio, Texas, Colorado, and California, participated.

The annual Pharmacy Day at the Capitol (PD@C) on February 12, 2014, was a huge success. For the first time, thanks to a generous educational grant from Pfizer Governmental Affairs, we offered a continuing pharmacy education activity preceding the Senate Lawn session. Heidi Ann Ecker, Director, Government Affairs and Grassroots Programs, NACDS, presented Grassroots Involvement in the Policymaking Process. We had over 60 pharmacists take part in the program.

More than 150 student pharmacists from The University of Arizona and Midwestern University, as well 50 plus pharmacists, came together

to demonstrate to the members of the Arizona legislature what the profession of pharmacy is all about.

Approximately 75 legislators and their staffs came down to the lawn to learn what pharmacists are doing across our state. Displays and demonstrations consisted of immunizations and preventative screenings, of which more than 100 total screening tests and/or vaccines were administered. Thank you to Fry’s Pharmacy for providing lunch for everyone in attendance.

This year marks the beginning of an exciting new partnership between The University of Arizona College of Pharmacy and AzPA as we co-presented the 47th Annual Southwestern Clinical Pharmacy Seminar. Held March 7th through 9th at the Hilton El Conquistador in Tucson, more than 240 attended this prestigious and time-honored event. The Seminar featured a keynote general session on Pharmacists as Providers. Participating in the panel discussion were Thomas Menighan, Executive Vice President and CEO of the American Pharmacists Association, and David Chen, Director of Pharmacy Practice Sessions at the American Society of Health-System Pharmacists. The presence of these two national association executives underscores Arizona’s reputation as a leader in the pharmacy profession.

Not only is AzPA the go-to source for quality continuing pharmacy education, your state association is the profession’s primary advocate as we monitor legislation that affects pharmacy. Our profession can change overnight with the passage of just one bill and in any given year we may monitor 50 or more proposed laws. AzPA contracts a professional lobbyist to maintain a consistent presence and influence at the state capitol.

Recognizing pharmacists as health care providers in our Pharmacy Practice Act is the first step of many to having pharmacists’ clinical services acknowledged by payers.

Kelly Ridgway, R.Ph. AzPA CEO

On March 12, 2014, an amendment was added to SB1043 (sponsored by Senator Nancy Barto) and approved by the House Health Committee to redefine the practice of pharmacy. (The text of this bill is on page 5.)

The national pharmacy associations are employing a federal strategy that would add pharmacists to the list of health care providers in the Social Security Act. On March 11, 2014, the first step toward this becoming a reality came in the form of HR 4190, introduced in the U.S. House of Representatives to recognize pharmacists as providers under Medicare Part B. The passage of legislation both nationally and locally may be a longterm effort — possibly years — that will require grassroots advocacy from all pharmacists. Please contact your elected representatives and tell them to support these important pieces of legislation.

In further support, consider joining the AzPA Legislative Affairs Committee and making a contribution to the PharmPAC. I look forward to seeing everyone June 26-29, 2014 at the AzPA Annual Convention at the Wigwam Resort and Spa. The theme is Pharmacists as Providers: Changing the Game. Paul Abramowitz, Pharm.D., Sc.D. (Hon), FASHP, Executive Vice President and CEO of the American Society of HealthSystem Pharmacists will be the keynote speaker. Highlights of the Convention are featured on the inside cover of this journal. Come and be part of this exciting event.

Spring 2014 • Arizona Journal of Pharmacy • 3

New Members

WELCOME NEW MEMBERS PHARMACISTS Frank J. Labarge Navela Bhuiyan Amanda DeJong Amanda Flory Dory Hardy Gabrielle Ocampo Roshni R. Patel Angela Becker Tracey L. Blanton Lisa Joan Buckner Jasmine Chantel Chase Cristina Comparini Myriam Concepcion Taylor Froiland Laura Gold Jody Johnson

Amy S. Kille Eric C. Kutscher Miao-Chen Lin Deborah C. Mack Dionis F. Malo, Jr. Neil Monroe Kate Mai Nguyen Rachel Richmond Venisha D. Rosenthal Carol A. Schneiderman Brian L. Schulman Rajkumar Sevak Teresa E. Smith Nikita N. Patel Elise Wheeler Dong Tran

ASSOCIATES John Fezza Betsy McKenna TECHNICIANS Thomas G. Joy Brenda D. Martinez Lori D. Santa Cruz Exaesperanza R. Secord Tricia Sheeley

STUDENT PHARMACISTS Jordan Call Courtney Canner Chad Dexter Vincent Lee Julie Nguyen Robert Prinz Delia Saadeh

Cheers for Volunteers!

Thank you to all of our volunteer members who devote so many hours to AzPA, serving as committee chairs, committee members, board of directors, CE and certificate program faculty, and to our wonderful student pharmacists and residents who select AzPA as one of their didactic rotations.

We could not do what we do without all of you. We appreciate you!

Stacy Haber Elizabeth Pogge Lindsay Davis Brian Erstad Scott Hardy Carol Rollins Betty Louton Grace Akoh-Arrey Lisa Goldstone Nicole Kitts Whitney Rice Ryan Gries Andrea Woodard Kalani Anderson Janet Cooley 4 • Arizona Journal of Pharmacy • Spring 2014

Tamara Krekel Kristyn Straw Martha Fankhauser Taylor Jackson Quan Pham Amelia Duke Matthew Aronson Grant Metcalf Huong Le Julie Nguyen Tina Pham Laura Tsu Mindy Burnworth Scott Hall Stephen Perona David Lee Robert Squire Kevin Boesen Jeannie Lee Carol Rollins Emily Lundeen Heather Leinbach Kerry-Ann Fuller Thanh-Nga Nguyen Cory Jenks Terri Warholak

Ken Baker Sandra Leal Amy Kennedy Bob Lipsy Mark Redell Chris Peric Hanna Phan Roger Morris Joe Rowan Brad Barron Mark Rhoads Chris Perry John Sears Steve LeMahieu Mark Murphy Cheryl Frush Vince Angichiodo Teresa Stickler Yu-Chieh Phan Jon Glover Lori Drea Tom Henry Radha Manian Scott Hardy Padma Sundareshan Nicole Romney

Association News Arizona Pursues Provider Status SB 1043 naturopaths; prescription authority; pharmacy board ARTICLE 1 BOARD OF PHARMACY: 32-1901-DEFINITIONS

69. “Practice of pharmacy” means, FURNISHING THE FOLLOWING HEALTH CARE SERVICES AS A MEDICAL PROFESSIONAL: a. Interpreting, evaluating and dispensing prescription orders in the patient’s best interests. b. Compounding drugs pursuant to or in anticipation of a prescription order. c. Labeling of drugs and devices in compliance with state and federal requirements. d. Participating in drug selection and drug utilization reviews, drug administration, drug or drug related research and drug therapy monitoring or management. e. Providing patient counseling necessary to provide pharmaceutical care. f. Properly and safely storing drugs and devices in anticipation of dispensing. g. Maintaining required records of drugs and devices. h. Offering or performing of acts, services, operations or transactions necessary in the conduct, operation, management and control of a pharmacy. i. IMPLEMENTING, MONITORING AND MODIFYING DRUG THERAPY PURSUANT TO A PROTOCOL-BASED DRUG THERAPY AGREEMENT WITH A PROVIDER AS OUTLINED IN SECTION 32-1970. j. INITIATING AND ADMINISTERING IMMUNIZATIONS OR VACCINES PURSUANT TO SECTION 32-1974.

STAY TUNED!

CALL FOR NOMINATIONS 2013-2014 azPA board of directors nominations A membership privilege of the Arizona Pharmacy Association is the ability to participate in the election of the Board of Directors and Officers. Your voice is important to the future of our profession and AzPA! Please consider running for a position on the 20142015 AzPA Board of Directors.

Open Positions for the 2014-2015 AzPA Board of Directors: • President-Elect • Treasurer • Community Pharmacy Academy Chair-Elect • Geriatric Care Academy Chair-Elect • Health-System Academy Chair-Elect • Managed Care Academy Chair-Elect • Technician Academy Chair-Elect • Southeast District Director • Southwest District Director • Industry Representative Nominations are now being accepted at: www.azpharmacy.org/2014-2015BOD

awards nominations Honor your peers and colleagues by nominating them to receive an award.

• • • • • • • •

Bowl of Hygeia Award AzPA Pharmacist of the Year Award AzPA Technician of the Year Award AzPA Hall of Fame Awards Elias Schlossberg Award Distinguished Young Pharmacist of the Year Award Excellence in Innovation Award Exemplary Patient Care Award

Complete awards criteria is available on the Awards Nominations link.

If you know someone who is worthy of receiving one or more of our annual awards, please submit your nominations at: www.azpharmacy.org/2014Awards DEADLINE FOR ALL NOMINATIONS IS MAY 3, 2014 Spring 2014 • Arizona Journal of Pharmacy • 5

Association News SAVE THE DATE! 2014 Arizona Pharmacy Association Annual Convention Join us June 26 to 29, 2014, at the beautiful Wigwam Resort in Litchfield Park, Arizona. This year’s conference theme, Pharmacists as Providers: Changing the Game celebrates the changing landscape of the profession. This is the largest annual pharmacy convention in Arizona and offers an extraordinary selection of continuing education programs, networking sessions, opportunities for personal and professional growth, entertainment, and fun!

On Thursday, June 26, 2014, three optional pre-conference certificate training programs will be offered. You may choose from the AzPA Anticoagulation Certificate Program, the AzPA Immunization Training Program or Delivering Medication Therapy Management Services Certificate Training Program.

All three programs require separate registration.

The conference officially begins on Friday, June 27, 2014 with the Opening General Session featuring Paul W. Abramowitz, Pharm.D., Sc.D. (Hon), FASHP, Executive Vice President and CEO of the American Society for Health-System Pharmacists. Continuing pharmacy education activities on Friday include a Residency Preceptors Workshop.

The AzPA Annual Awards Luncheon, will take place on Friday at 11:00 am when we recognize the contributions and accomplishments of our members and mark the transition of leadership for our association.

Saturday, June 28, 2014, features a day-long workshop of Transitions of Care as well as the annual poster session and contest and the popular Student Track. The Independent Pharmacy Owners Track returns on Sunday, June 29, 2014 and the AzPA Town Hall Law Update starts at 8:00 am on Sunday.

The annual PharmPAC Drawdown winners will be announced during the Town Hall. AzPA members can purchase tickets for a chance to win cash prizes.

Over the course of this three-day meeting, more than 28 continuing education programs will be offered with attendees having the opportunity to earn up to 15.0 contact hours of CPE (1.50 CEUs).

Don’t miss this year’s interactive exhibit hall. More than 50 exhibitors will be showcasing their companies and organizations in the Wigwam Ballroom. Explore the exhibit hall using your AzPA Bingo Card and be entered into a drawing for prizes. As always, we will have great food, fun, and prizes.

See you in June at the Wigwam Resort & Spa in Litchfield Park as we champion: : ERS D I OV PR S SA IST C T MA AR cHANGing PH

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a m e

Registration is available on the AzPA website at www.azpharmacy.org/2014Convention 6 • Arizona Journal of Pharmacy • Spring 2014

2014 Arizona Pharmacy Association Annual Convention Early Registration Fees until June 6, 2014 Full Three-Day Registration AzPA Members Pharmacist $345 Allied Pharmacy* $200 Student $ 75 Non-members Pharmacist $545 Allied Pharmacy* $250 Student $100 SINGLE-DAY REGISTRATION AzPA Members Pharmacist $150 Allied Pharmacy* $100 Student $ 25 Non-members Pharmacist $200 Allied Pharmacy* $125 Student $ 50 *For the AzPA Annual Convention registration, Allied Pharmacy category includes associate, resident, pharmacy technician, nurse, industry representative, and other non-pharmacist attendees.

CERTIFICATE PROGRAMS Offered Thursday, June 26, 2014 Early registration until June 1, 2014 • AzPA Immunization Training • AzPA Anticoagulation Management • Medication Therapy Management AzPA Member Pharmacist AzPA Member Allied Pharmacy** Non-member Pharmacist Non-member Allied Pharmacy**

$350 $250 $450 $350

**For the Immunization, Anticoagulation, and MTM Certificate Programs, Allied Pharmacy category includes resident, student pharmacist and nurse attendees only. No technician registrations permitted.

For complete information about the AzPA Annual Convention, visit www.azpharmacy.org

Arizona Pharmacy Association 2014 Annual Convention REGISTRATION FORM OR REGISTER ONLINE TODAY AT WWW.AZPHARMACY.ORG! First Name: __________________________ Last Name: _______________________________ Organization/Pharmacy:__________________________Professional Designation ______________ Preferred First Name (for name badge): ____________________ Address:___________________________________________________________________________________ City/State/Zip:_______________________________________________________________________________ Daytime Phone: ____________________ E-mail address: __________________________________ Date of Birth (MMDD only) __________ NABP eProfile ID # ___________ NPI _________________ (Date of Birth and NABP eProfile ID# required to receive continuing pharmacy education credit.)

AzPA Member? Yes__ No __ Special Needs/Disabilities: ___________ Dietary Need: ___ Vegetarian ___ Gluten-Free I. Early Registration Fees until 06/06/2014

AzPA Member Pharmacist

NonMember Pharmacist

AzPA Member Allied Pharmacy*

NonMember Allied Pharmacy*

AzPA Member Student

NonMember Student

FULL: 3-DAY REGISTRATION

$345

$545

$200

$250

$ 75

$100

SINGLE DAY __FRI __SAT __SUN

$150

$200

$100

$125

$ 25

$ 50

SPOUSE/GUEST : 3-DAY

$200

$200

$200

$200

$200

$200

II. Standard Registration Fees between 06/07/2014 and 6/20/2014

AzPA Member Pharmacist

NonMember Pharmacist

AzPA Member Allied Pharmacy*

NonMember Allied Pharmacy*

AzPA Member Student

NonMember Student

FULL: 3-DAY REGISTRATION

$395

$595

$250

$300

$ 80

$105

SINGLE DAY __FRI __SAT __SUN

$175

$225

$125

$150

$ 35

$ 60

SPOUSE/GUEST : 3-DAY

$250

$250

$250

$250

$250

$250

Section I Total

Section II Total

*For AzPA Annual Convention Registration, Allied Pharmacy category includes associate, pharmacy technician, PGY resident, nurse, industry representative, and other non-pharmacist attendees.

Federal Commissioned Pharmacists: Please contact the AzPA office at 480.838.3385 for available discounts.

SEPARATE REGISTRATION IS REQUIRED FOR THE THURSDAY, JUNE 26, 2014 OPTIONAL CERTIFICATE TRAINING PROGRAMS. III. AzPA Anticoagulation Certificate Program Full Day 6/26/14

AzPA Member Pharmacist

Non-Member Pharmacist

AzPA Member Resident or Student

Non-Member Resident or Student

EARLY - UNTIL 6/1/14

$350

$450

$250

$350

STANDARD - Between 6/2/14 & 6/16/14

$400

$500

$300

$400

AzPA Member Pharmacist

Non-Member Pharmacist

AzPA Member Resident or Student

Non-Member Resident or Student

EARLY - UNTIL 6/1/14

$350

$450

$250

$350

STANDARD - Between 6/2/14 & 6/16/14

$400

$500

$300

$400

IV. Medication Therapy Management Certificate Program Full Day 6/26/14

V. AzPA Immunization Training Program Full Day 6/26/14

AzPA Member Pharmacist

Non-Member Pharmacist

AzPA Member Resident or Student

Non-Member Resident or Student

EARLY - UNTIL 6/1/14

$350

$450

$250

$350

STANDARD - Between 6/2/14 & 6/16/14

$400

$500

$300

$400

Section III Total

Section IV Total

Section V Total

AzPA 2014 Annual Convention REGISTRATION FORM PAGE TWO Please indicate which continuing pharmacy education track you plan to attend. Please make a selection for each day you will be attending the convention: Friday, June 27, 2014

____ Residency Programs Workshop

____ Convention Breakout Sessions

Saturday, June 28, 2014

____ Transitions of Care Workshop

____ Convention Breakout Sessions

Sunday, June 29, 2014

____ Independent Pharmacy Track

____ Convention Breakout Sessions

Section VI. PharmPAC Purchase a PharmPAC Drawdown ticket or make a contribution to the PharmPAC. - Must be an AzPA Member

NUMBER OF TICKETS

CONTRIBUTION

PharmPAC Tickets

Section VI Total

$100.00

PharmPAC Contribution - See suggested contribution levels.

Contributions to the PharmPAC are for political purposes and participation is strictly voluntary. The recommended contribution guidelines are only suggestions and AzPA members are free to give more, less or nothing at all.

Contributions to the PharmPAC are not tax deductible as a charitable contribution for federal income tax purposes.

All PharmPAC members must be an Arizona Pharmacy Association (AzPA) member to make a contribution to PharmPAC. Suggested Contribution Levels Member Category Students Technicians Pharmacists

Annual Contributions $10 $25 - $50 $100 - $500

Section VII. Arizona Pharmacy Foundation (APF) The Arizona Pharmacy Foundation is a 501 (c) (3) charitable organization. All donations are tax deductible.

Section VII Total

DONATION

APF Donation Section VIII. Additional Optional Events

TICKET PRICE

Friday, June 27, 2014 Exhibit Hall Reception - Adult

$45.00

Friday, June 27, 2014 Exhibit Hall Reception - Child (ages 5-12)

$10.00

Saturday, June 28, 2014 Exhibit Hall Lunch - Adult

$45.00

Saturday, June 28, 2014 Exhibit Hall Lunch - Child (ages 5-12)

$10.00

Friday, June 27, 2014 Awards Luncheon - Single Ticket

$50.00

Friday, June 27, 2014 Awards Luncheon - Table of 10

$450.00

Adopt-A-Technician - includes AzPA Technician Dues

$200.00

Adopt-A-Student - student must be an AzPA member

$75.00

NUMBER OF TICKETS

Section VIII Total

Name(s) of Registered Guest(s)/Spouse: Name(s) of Child(ren) Attending Events: Names(s) of Student(s)/Technician(s) [optional]:

PAYMENT SUMMARY Total Due (Sections I, II, III, IV, V, VI, VII, VIII)

$

Charge Card: Visa ___ MasterCard ___ Amex ____ Discover ____

Check # _____________

Card Number ______ - ______ - ______ - ______ Exp. Date _______ Security Code _______ Signature ________________________________________________________________________ Make checks payable to AzPA and mail this form to AzPA Annual Convention, 1845 E. Southern Ave., Tempe, AZ 85282 or fax to 480 838-3557 Phone: 480 838-3385 www.azpharmacy.org ALL TIMES AND PROGRAMS SUBJECT TO CHANGE.

PAPA Stress, the Family, and the Disease of Addiction

by Sandra Rankin, Ph.D., LPC, LPCC, Second Wind Counseling & Support Center According to the American Society of Addiction Medicine, addiction is a “chronic, neurobiological disease that is influenced by genetic, psychosocial, and environmental factors”. Notice the words “chronic” and “disease”. We all know that other chronic diseases can involve remission as well as relapse, bad behaviors, disability, or even death. Addiction is no different, meaning one must be involved in recovery related activities, and sometimes treatment, to put the disease in remission and prevent relapse.

Addiction affects major areas of the brain, with the prefrontal cortex being the first area affected by drugs and alcohol. This is where judgment, impulse control, and self-monitoring are controlled. This area also supports the temporal lobes using memory to guide and learn behaviors!

Considering all that the prefrontal cortex is responsible for, it is not surprising that using alcohol and drugs results in a person being unpredictable, irrational, self-centered, poor judgment, argumentative, irresponsible, unorganized, and defiant. Do these behaviors sound familiar? In short, use of drugs and alcohol can injure the brain in a way that is similar to other forms of brain injury, all of which have a dramatic impact on the family.

For the family, losing a loved one to addiction is just that: a loss. This particular type of loss causes some emotional confusion for family members, because their loved one is still physically present but addiction has turned that person into someone the family does not recognize. The result is boundary confusion within the family and changes in how the entire family interacts. The changes are so drastic that researchers in one study observed that “…the disease has left a stranger in their midst who has become the predominant presence in every conversation and major decision” (Landau & Garrett, 2008).

It is no secret that using/drinking leads to health problems for the one doing the using/drinking. But what does surprise most family members is that addiction makes the entire family sick because of the stress that comes with living with an addicted loved one. Studies have repeatedly shown that family members of those in active addiction tend to have higher medical costs (physical and psychological) than families of those in recovery, or families without an addicted loved one. The increased medical bills are a result of the symptoms caused by the constant stress surrounding addiction.

Stress is the perception of a threat. In this case, families of those with addiction are threatened by changes within the family, the fear that nothing will ever change, and fear their loved one will die. Although many family members ignore the severity of the situation and hope it

resolves on its own, most deny they ignore anything but admit to keeping the secret because it’s nobody’s business what’s going on in their family. The truth is that many families are aware of the stigma associated with having an addicted loved one, just like the stigma associated with having an addiction. Keeping the secret is easier and less embarrassing. Let’s face it, families typically don’t want to talk about their experiences because of guilt, shame, and blame. The last thing they need to hear is that it’s somehow their fault their loved one has an addiction. So, they keep the secret. The secrecy adds to the problem, increases family stress, and eventually increases the family’s trips to the doctor for stress related symptoms. Interestingly, families tend to be just as dishonest as their addicted loved one when it comes to talking to the doctor. For example, we’re all familiar with the alcoholic who goes to the doctor for high blood pressure, anxiety, or some other symptom and when they’re ask if they drink, they say “no, I never drink” or “well, only a drink once in a while”. So, the doctor only treats the symptoms and the true problem – the alcohol – is never addressed. The addict may go to the doctor because they can’t sleep but they neglect to mention they are using cocaine. Well, the family is typically no better. They go to the doctor for similar symptoms but when ask about drinking they say “no, I’m not drinking” but don’t tell the rest of the story: “no, I’m not drinking but my son/daughter/spouse is.” Again, the root cause of addiction induced stress is not addressed.

Stress causes the body to go in to fight or flight mode.

When in fight or flight mode, the body is put on alert, meaning several systems in the body are heightened to manage the perceived threat and protect the body, while other bodily functions are shut down. When the body does not function as it should, physical and psychological symptoms appear and, over time, get worse. As the addiction progresses, stress builds, and health problems increase for the family members and addicted loved one.

Addiction has the same effect on the family and the addicted loved one. Addiction brings stress to family members and the addicted loved one. Stress that is not managed leads to physical and psychological illness.

Recovery can moderate stress for family members and the addicted loved one. It is the personal responsibility of each family member, as well as the addicted loved one, to get in and stay in recovery. The disease can be managed, but no one can do it alone. Addiction is a family disease which means recovery needs to be a family affair. Not dealing with addiction as a family can lead to continued problems within the family, including a lack of understanding of the lifestyle changes necessary to support lifelong recovery.

Too many families get stuck in analyzing the situation to determine whether or not they need help or whether or not their loved one has an addiction. The real question should be whether or not the goal is more of the same, or something better.

Spring 2014 • Arizona Journal of Pharmacy • 9

Legislative Update As of March 1, 2014 Laura Carpenter, J.D., RPh has decided to step down as chair of the AzPA Legislative Affairs Committee. Ray Clark, AzPA President, has appointed Mark Boesen, Pharm.D., J.D., to assume the role.

Mark has a long history with AzPA and has chaired this committee in the past. We thank Laura for her service and support and are grateful to Mark for his willingness to serve as Chair.

Here is a recap of the bills AzPA is following this legislative session. As a reminder we discuss these bills as well as other pharmacy related issues on the monthly Legislative Affairs conference calls which occur the first Wednesday of every month at 12:00 pm.

All AzPA members are welcome to attend the monthly meetings. If you are interested in joining the discussions, contact Mark Boesen, Legislative Committee Chair, at legislative@azpharmacy.org or Kelly Ridgway, AzPA CEO, at kelly@azpharmacy.org.

Mark Boeson AzPA Legislative Affairs Committee Chair legislative@azpharmacy.org Jeff Gray, R & R Partners, AzPA Lobbyist

H2078: tech correction; public health

The proposed strike-everything amendment to HB 2078 states that specified insurers who provide coverage for cancer treatment medications may not require a higher co-payment, deductible or coinsurance amount for patient-administered cancer medications that those medications that are administered by a health care provider.

First sponsor: Rep. Carter

H2086: tech corrections; technical registration bd

The strike-everything amendment to HB 2086 makes it unlawful for any commercial entity to sell or trade a finished drug product containing any quantity of dextromethorphan (DXM) to a person under 18 years of age, for a person under 18 to purchase a product containing any quantity of DXM and for any person to possess, receive or distribute DXM unless the person is registered pursuant to the FDA or licensed with the Arizona State Board of Pharmacy (Board).

First sponsor: Rep. Carter

H2101: vaccines; study committee

Establishes a 15-member Vaccine Financing and Availability Study Committee to develop recommendations regarding the existing system of financing and availability of childhood and adolescent vaccine products and the adequacy of reimbursement levels for vaccines administered by private and public providers in all counties in Arizona. The Committee is required to report to the Governor and the Legislature by December 15, 2014. Selfrepeals January 1, 2016.

Modifies requirements for the use of a controlled substance for injuries covered by workers' compensation, including requiring the medication to demonstrate "clinically meaningful improvement in function" (defined).

Preauthorization is required for a prescription order for opoid medication at certain dosages. Requires physicians to report various results and steps of prescription use and monitoring to the carrier, self-insured employer or Industrial Commission. Specifies procedures for noncompliance by a physician.

For the purpose of the Criminal Code, the definitions of "dangerous drug" and "narcotic drugs" are expanded to include specified substances. An entity who sells or otherwise furnishes any precursor chemical or regulated chemical to any person in Arizona and is required transactions to report to a federal agency is no longer required to submit a report of the transactions to the Department of Public Safety. Emergency clause.

A nursing care institution's quality assessment and assurance committee established pursuant to federal code is authorized to establish written guidelines or procedures for making therapeutic substitutions if the committee membership includes a licensed pharmacist. A pharmacy used by a nursing care institution is authorized to make therapeutic substitutions consistent with the institution's written guidelines or procedures if the substitution is approved by the patient's licensed health care provider.

School districts and charter schools are required to post on their websites whether a registered nurse is assigned to each school and an explanation of the manner in which student health issues will be addressed at the school.

Required reports on immunizations are also required to be posted on school websites.

The statutory life of the Arizona State Board of Pharmacy is extended 8 years to July 1, 2022. Retroactive to July 1, 2014.

It is unprofessional conduct for a health professional to claim board certification as a specialist if this is not true or the status is not current, or to fail to supply the name of the entity granting the certification when making a claim of board certification in any form of "advertisement" (defined). AS PASSED SENATE.

First sponsor: Rep. Brophy McGee

The State Board of Pharmacy must require applicants for initial licensure to submit fingerprints for the purpose of obtaining a state and federal criminal records check. The Board is no longer required to establish by rule a list of drugs that cannot be used by dispensing pharmacists as generic equivalents for substititon, or to adopt rules for implementing regulations on "legend drugs" (defined). For the purpose of statutes regulating naturopathic physicians, the definition of "drug" is modified to exclude any drug that is reclassified from schedule III to schedule II after January 1, 2014.

A workers' compensation carrier, self-insured employer or the Industrial Commission are not liable for payment for medications that a physician dispenses unless the physician dispenses the medication within 72 hours after the employee's accident and dispenses no more than a single 7-day supply of the medication.

Updates the version of the standard implementation guide that dispensers of controlled substances must use for the Controlled Substances Prescription Monitoring Program, and expands the list of persons who may receive data collected by the Program to include a delegate who is authorized by a prescriber or dispenser.

AHCCCS contractors are required to intervene with case management services if an AHCCCS member has prescriptions written from more than one health care professional or filled by more than one pharmacy within a 30-day period and must restrict the member to a single prescriber and a single pharmacy.

Health care professionals who prescribe medications and licensed pharmacists who are AHCCCS providers are required to check the database developed under the Controlled Substances Prescription Monitoring Program before prescribing or filling a prescription for a controlled substance for an AHCCCS member.

Statute does not prohibit a pharmacist from filling a prescription order for a drug or device issued by a medical practitioner licensed by the appropriate licensing board of any foreign country, instead of only Canada or Mexico.

By July 1, 2015, the Department of Insurance is required to prescribe a single, standard form for requesting prior authorization of prescription drug benefits and establish specified prior authorization requirements for health care insurers. Beginning January 1 2016, a health care insurer that provides prescription drug benefits is required to use the prior authorization process established by the Dept. A prior authorization request is deemed granted if the health care insurer fails to use the prior authorization process.

The list of oral prescription pharmaceuticals that licensed optometrists are authorized to prescribe is expanded.

Licensed optometrists are prohibited from prescribing, dispensing or administering these pharmaceuticals to a person under 6 years of age.

First sponsor: Sen. Barto

H2221: workers’ comp; controlled substances

H2453: synthetic drugs; reporting H2549: nursing care institution; therapeutic drugs

H2573: schools; immunizations; registered nurses; posting S1041: board of pharmacy; continuation S1042: health professionals; specialty status claims S1043: naturopaths; prescription authority; pharmacy board

S1075: workers’ comp; physician-dispensed medications S1124: controlled substances prescription monitoring program S1296: AHCCCS; contractors; prescription monitoring S1297: AHCCCS; controlled substances; monitor S1337: foreign prescription orders S1361: health insurance; prescriptions; prior authorization S1362: optometrists; pharmaceutical agents

10 • Arizona Journal of Pharmacy • Spring 2014

First sponsor: Rep. Fann

First sponsor: Rep. Farnsworth First sponsor: Rep. Carter

First sponsor: Rep. Meyer First sponsor: Sen. Barto First sponsor: Sen. Barto

First sponsor: Sen. Reagan First sponsor: Sen. Ward First sponsor: Sen. Ward First sponsor: Sen. Ward First sponsor: Sen. Ward First sponsor: Sen. Ward

First sponsor: Sen. Barto

Arizona State Board of Pharmacy Critical Changes to CSPMP Access 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), student pharmacist (mentee), and technician (mentor or mentee) members.

For more information about how to be a part of the AzPA MCP, contact Kelly Ridgway, AzPA CEO at kelly@azpharmacy.org

SUPPORTING PHARMACISTS ADVANCING CAREERS Find the best jobs and highly qualified pharmacists Arizona has to offer.

Critical Changes to CSPMP Access The Controlled Substances Prescription Monitoring Program (CSPMP) changed vendors to Optimum Technologies effective December 21, 2013. Notice of this change was sent via email to all current users. Your original PIN # is needed to reset your password in order to gain access to the CSPMP database. Your username (which the previous vendor called Login ID) remains the same. If you do not have your original PIN #, or are unable to access the system, please email Cindy Hunter at chunter@ azpharmacy.gov from the email associated to your account. If your email has changed we’ll need your user name and the last four digits of your SSN to verify your registration.

PLEASE NOTE: Medical marijuana card information has not been uploaded to the new CSPMP system as of yet.

Beginning date for release of this data is March 15th.

The Controlled Substances Prescription Monitoring Program (CSPMP) is a program developed to promote the public health and welfare by detecting diversion, abuse, and misuse of prescription medications classified as controlled substances under the Arizona Uniform Controlled Substances Act. To learn more about Arizona’s Controlled Substances Prescription Monitoring Program history visit http://www.azpharmacy.gov/pmp/about.asp It’s the Law A.R.S. § 36-2606 requires each medical practitioner who is licensed under Title 32 and who possesses a DEA license to register with the CSPMP. Each DEA license should have an associated registration. There is NO fee to the practitioner for this registration. This registration includes: MD, DO, DDS, DMD, DPM, HMD, PA, NP, ND, OD, and DVM. Residents may register using the hospital DEA number and appropriate suffix.

Accessing the Data The Arizona State Board of Pharmacy Controlled Substances Prescription Monitoring Program (CSPMP) grants system access accounts to practitioners and pharmacists so that they may look up, view, and print controlled substance dispensing information on their specific patients directly via user name and password.

Access is granted to individuals only—not to clinics, hospitals, pharmacies, or any other health care facility. Pharmacists must register for access to the database. To register go to: https:// www.azrxreporting.com/newregistration.aspx?Jobid=4 Currently only 6,071 – or 27.5% - of all licensed Arizona practitioners and 3,299 Arizona-licensed pharmacists (51.4%) are registered in the CSPMP. If you are not currently registered to access the data base, please take the time to do so and encourage your pharmacy and medical practitioner colleagues to do the same.

ONLINE CAREER CENTER

www.azpharmacy.org/jobs Spring 2014 • Arizona Journal of Pharmacy • 11

Technician Spotlight Building Strong Relationships with Patients and Clients

by Kalani Anderson, C.Ph.T.

With 28 years of experience under her belt as a pharmacy technician, Beth Serran has seen a lot. From clinical to retail, Beth has made IVs, chemotherapy, delivered unit dose orders to nursing stations, and served countless individual patients and health care providers face to face or via the phone. Since 2009, she has worked as part of a team of health care providers at Cigna Medical Group’s Paseo Multi-Specialty Center in Glendale, AZ. This Center is a hub of medical services where physicians of various specialties see patients who are then able to go next door to the pharmacy for their prescriptions and obtain other services in the health care system. Along with processing prescription orders, taking refills, insurance billing, and handling cash transactions, Beth’s role in this innovative health care team is to work hand in hand with providers to deliver quality care and to ensure patient satisfaction and safety. This last role is what constitutes the most fulfilling aspect of Beth’s career: “building strong relationships with patients and clients.”

A talented individual, Beth has found ways to bring her unique skills to improve the workplace for herself and those she works with. For example, she has used sewing skills honed over many years of making draperies, clothing, and upholstery in her home to create surgical hats, shirts, and scrubs for doctors, nurses, and other co-workers while working in the hospital setting. She has also used her creative talents to design and develop personalized nametags that you might spot throughout various pharmacy settings in the valley.

Beth’s unique linguistic skills have also come in handy in many instances. Born in the Philippines, Beth’s native tongue is Tagalog. At age 12, she came to the United States with her parents and settled in San Francisco where she spent the next 24 years. Between her time there and eight years in Colorado, she picked up enough Spanish to help out with Hispanic clientele.

Prior to settling in Arizona, she and her husband spent three years living in Bangkok, Thailand with shorter stints in Singapore and the Philippines. During that period, Beth learned workable Thai and also had many adventures including visits to a Tiger Farm with monk-trained tigers as well as on Elephant Treks through tropical rainforests.

Since moving to Arizona, Beth joined AzPA to get involved with technician colleagues and share her knowledge and experiences that have far-reaching application. For example, she describes the key to customer retention as being patient safety and “outstanding patient satisfaction.” She suggests making these guiding principles in all pharmacy practices. To new technicians, Beth advises proactively seeking out additional responsibilities and learning new skills (even skills you think you will never need). They will be useful when least expected.

Lastly a bit of advice for employers: invest in your technicians!

The skills you help your technicians develop will provide significant returns in the quality of their work as well as in positive word of mouth long after an employee has moved on.

Beth is quick to praise past employers such as Kaiser-Permanente for their heavy emphasis on training and building up their technicians. Such praise helps build their image in the eyes of potential employees as well as customers who see it as a place that takes pride in its work and will take good care of them.

While Beth has already enjoyed a long and successful career, she looks forward to many wonderful experiences to come in her professional future. To contact Beth for networking purposes, she recommends her email: beth.serran@cigna.com. Don’t hesitate to say hello at future events and conferences as well!

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.

CONNECT ONLINE:

Beth Serran, C.Ph.T., communes with monk-trained tigers in Thailand.

12 • Arizona Journal of Pharmacy • Spring 2014

Feature Pharmacist Critical Care with the Emphasis on ‘Care’

by Ryan Gries, Pharm.D., Candidate, Midwestern University College of Pharmacy - Glendale, Class of 2014

Dyan Cherry, Pharm.D., is a critical care pharmacist at Scottsdale Healthcare Osborn Medical Center. She is a graduate of Midwestern University in Glendale and completed her Acute Care PGY-1 Residency at Scottsdale Health care in 2010. Dr. Cherry was honored in 2014 at the AzPA’s Annual Convention with the Distinguished Young Pharmacist of the Year Award.

She has had the unique opportunity to grow within the Scottsdale Health care System having served as pharmacy technician, intern, resident, and in her current role.

How did you find yourself in the pharmacy profession?

I was always a chemistry fan. When I worked for the state at a group home for girls on parole, I became interested in their psychotropic medications due to side effects such as: obesity, depression, somnolence, etc. That led me to take a psychological psych course which I found fascinating. At about the same time, I had an operation at Mayo and appreciated the process of my surgery management team. They were able to minimize post-operative conditions with pharmacological therapies.

Later, I ended up working at Scottsdale Health care as a pharmacy technician and the stars aligned as I was accepted into Midwestern’s pharmacy program.

What do you like most about your current role?

I have the drive to do more and I am lucky that in the ICU here I have people that want me to want to do more. They want to include me and we all take the time to teach and learn from each other. I feel like we are one big happy family where I get a chance to learn and grow and experience new things every day.

I joke that I’m a magnet for weird and I absolutely love it.

How have you built such a positive rapport with members of the health care team?

In general, I think people take the time to criticize but they don’t take the time to extend a compliment or to appreciate people around them. I believe I’ve taken the time to really get to know the people I work with and allow them to get to know me. I also don’t assume I’m right. I’ve found it best to avoid “I know” or “I’m right.” “Hey, I’ve got this idea” or “What do you think?” includes the provider in the decision making process.

MISSION STATEMENT

How do you feel about the push for graduates to conduct a one year residency?

There’s a wealth of information pharmacists get in school and we have the capacity and are given a toolset to be part of an interdisciplinary team taking care of patients. I don’t think we should be in the wings or just support crew, we should be directly involved. Completing a residency encourages pharmacists to be involved in that interdisciplinary setting and in the end, corresponds with better patient care.

Why do you choose to be a member of AzPA and attending events like the Annual Convention?

I like the networking aspect. I get to see my previous faculty and run into students I may not have seen for a while, as well as other pharmacists I know. I like that it’s local and a little quieter in that way. I enjoy the annual meeting for the continuing education programing.

Who has been your best mentor in pharmacy?

I had a residency preceptor named, Motassam Khled. He knew everything and he knew everyone and if he didn’t know something, he knew where to look it up or who to ask. Everyone loved him. Some doctors would call him with questions about patients at other hospitals. Every chemo order he received, he was in the room checking up on the patient. He was very involved and well respected by the entire team. He had high expectations of me. Because he expected so much, I wanted to do even more.

Why is it important for you to precept students and residents?

I believe there is a sense of giving back. I feel there are good learning opportunities they can see from my rotation, a way to look at patients. They have the chance to experience what it means to be a clinical pharmacist. Most of all, I know one day my students will be all by themselves and I want them to be exceptional, to know that they don’t know everything and I want them to know where to find it. Students have a fresh perspective.

I get an opportunity to learn from my students, perhaps, as much as they learn from me. They bring enthusiasm and passion which reminds me every day why I am doing what I am doing.

Advise for young professionals?

I do what I do because I love my job and I love the team that I work with. There are so many options in pharmacy and ways to go… figure out what you are passionate about and run with it.

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.

Dyan Cherry, Pharm.D. Critical Care Pharmacist

The Voice of Pharmacy in Arizona

Spring 2014 • Arizona Journal of Pharmacy • 13

Featured Article Patient Satisfaction with a Medication Mail-back Program

by Andrea Woodard, Pharm.D. Candidate, University of Arizona College of Pharmacy, Class of 2014; Kelly Mathews, Pharm.D., Avella Specialty Pharmacy; and Janet Cooley, Pharm.D., BCACP, University of Arizona College of Pharmacy Introduction Unused, unwanted and expired medications in the home can lead to accidental poisonings, increase the risk of diversion among vulnerable populations, and contribute to environmental pollution.1 Vulnerable populations include children, adolescents, and pets. There are many causes that can lead to the accumulation of unused medications in the home.

Expiration and discontinuation of both prescription and over the counter medications can occur at the request of a prescriber and the patient for a multitude of reasons including the presence of adverse effects, low affordability and therapy changes; creation of surplus medications in the home is a consequence of the natural life cycle of prescribing, adjusting, and following therapy. Fueling this problem, many patients are unaware of potential resources for the proper disposal of their medications. Some patients live in areas where such resources are unavailable or require a significant amount of patient means including expendable time, gas, and transportation.2,3 According to a 2006 survey of 301 patients in a Washington State outpatient pharmacy, about half of respondents stored unused or expired medications in the home.4 Another report by Grasso et al. discusses similar results from various surveys conducted around the country and abroad.1 If there are frequent reports of accumulated unused medications in the home, one might inquire as to the fate of such medications.

The concern of unused medications in the home stems from the risk of exposure to vulnerable populations. Accidental poisonings have been reported to account for about 165 children’s emergency room visits a day in the U.S.5 Further, use of prescription opiates for non-medical use is also of concern. In some states,

overdoses due to prescription opiates for non-medical use have surpassed automobile accidents as the leading causes of death. Given that prescription drug abuse among teens is second only to marijuana use in the U.S. adds to this concern.1 Unused oncological medications in the home also pose a significant risk.

Oncology medications come with specific handling precautions because they are carcinogenic, mutagenic and teratogenic.

When these medications are administered in the hospital or infusion centers, health care providers must take precautions to limit their exposure to these chemicals.

They are also legally required to follow very specific disposal methods for any unused portion. This is because many oncology medications are classified as hazardous waste. Hazardous waste falls into one of two categories: (1) listed waste or (2) characteristic waste.

Listed waste will appear on one of four federally categorized lists (F, K, P and U). Characteristic wastes are regulated because they exhibit certain hazardous properties such as, ignitability, corrosivity, reactivity, and toxicity. A number of oncology medications appear on either the P or U lists.6 This makes it especially important to ensure that these products are disposed of properly to help prevent environmental contamination.

The proper disposal of medications can prevent negative externalities associated with accumulation of unused medications in the home. It is estimated that approximately 165 children are treated for accidental poisonings daily in the United States, a significant number considering many patients are unaware of available disposal options. Based on surveys conducted at various medication take-back events, one of the most common responses for alternative methods that would have been used to dispose of their medications is the trash.7,8 Not only can pharmaceutical waste in the trash affect the environment,8 trash receptacles are easy targets for children to access unused medications and poisonings can easily be avoided with proper disposal.9 Observation of Avella’s pharmacybased medication mail-back program can ascertain, from a patient’s perspective, the program’s ability to increase awareness and facilitate its use. The data collected will contribute to the little body of knowledge regarding this type of take-

14 • Arizona Journal of Pharmacy • Spring 2014

back program, especially regarding patients’ opinions about it.

The purpose of the project was to obtain patients’ feedback on the use of medication mail-back disposal envelopes through Avella Specialty Pharmacy.

Methods The project was a customer satisfaction survey conducted over the course of seven months from July 2013 to January 2014 at Avella Specialty Pharmacy in Phoenix, Arizona.

Method for determining who received a medication disposal envelope: The project took place at Avella Specialty Pharmacy, a call-center based compounding pharmacy. During normal operations, Avella pharmacy technicians call patients to offer medication refills.

After the start of the project, Take Away™ medication disposal envelopes were offered to patients if, during this phone call, it was identified that a person or pet had leftover medications due to discontinuation for any reason. Some possible reasons for discontinuation that were documented during these calls were: therapy was completed, therapy was changed, side-effects were encountered, continuation of therapy was cost prohibitive, or the patient was deceased. Medication disposal envelopes were offered to any patient who had any medications they wanted to dispose of but the offers were designed to stem from the refill call. Another way a patient could receive an envelope was through an adverse event follow up (through normal course of operations).

The medication disposal envelopes were free, postage-prepaid and pre-addressed to a third party disposal company. The disposal envelopes were mailed to patients in larger envelopes return addressed to Avella Specialty Pharmacy with pre-paid postage via First Class mail.

Included with the disposal envelope were instructions for use and a statement from Avella that informed the patient that they may be contacted for a survey. The statement also thanked the patient for properly disposing of their medications.

All Avella provided instructions were also available in Spanish upon request.

Method for surveying patient satisfaction: Medication disposal envelopes were

Featured Article Medication Mail-Back Program (continued from page 14) mailed to patients who requested them usually the same day. About one week to one month after the envelopes were mailed, patients were called and a satisfaction survey was conducted. If the patient agreed to do the survey, they were made aware that responses were confidential and used for evaluation of the service. The survey included five questions: • if any other medications were mailed besides the medication Avella inquired about • how much they agreed with the statement, “ The envelope was helpful” • how much they agreed with the statement, “The envelope was easy to use” • if they have heard about a medication disposal program before • how they normally dispose of medications The statements regarding helpfulness and ease were measured by a Likert scale.

Patients could strongly agree, slightly agree, slightly disagree, or disagree. Other information collected, which was obtained from the patient’s profile, included age and gender. The medication that the envelope was offered/requested for was also recorded.

The survey was conducted with patients, patient’s caregivers, or patient’s representatives in order to speak to the person who used the envelope.

The gender and age range among the data reflect patient demographics for consistency purposes. In many cases however, the survey was conducted with the patient for whom the medication was prescribed.

Processing of Take Away™ medication disposal envelopes: When patients placed their filled medication disposal envelopes in their mail box as instructed, the package was mailed to a third party company for incineration. Due to the nature of the envelope and third-party company, patients were instructed not to include controlled substances, sharps, or liquids greater than four ounces.

Each disposal envelope came with a barcode printed on it. This barcode was recorded before mailing to the patient. When received by the third party company, envelopes were tracked with the barcodes. The barcode had the potential to provide information on how many envelopes were returned and the weight of each envelope before incineration.

Development of the Survey: The survey is a compilation of selfdesigned questions and select questions from two previously conducted medication take-back surveys as a framework.

Incorporated from other surveys were the questions to elucidate what alternatives would have been used to dispose of medications and prior awareness of

Summary of Data Collected Number of participants versus non-participants Barcode of medication disposal envelope What, if any, other medication were included in the disposal envelopes besides the one Avella inquired about Level of agreement with the statement, “The envelope was helpful” Level of agreement with the statement, “The envelope was easy to use” Previous exposure to a medication disposal program How patients normally dispose of medications Patient’s age If the medication disposal envelope had been returned for incineration The medication disposal weight before incineration What medication the envelope was offered/requested for Table 1

medication disposal programs.2,3 Results Survey results: There were a total of 86 patients who were offered a medication disposal envelope. Of this total, 50 patients agreed to the offer. About 86% of patients who received an envelope were reached for the satisfaction survey while 79% of patients who were contacted agreed to participate in the survey.

Among those who agreed to participate in the survey, the majority of participants believed that the use of the disposal envelope was helpful (97%) and easy (100%) to use while every respondent stated that their envelope was mailed back.

The majority of participants had not heard of a medication disposal program previous to Avella’s offer (74%) and 41% of patients would normally dispose of their medications in the trash or toilet. The most popular disposal option was to throw medications into the garbage.

Other data collected: Xeloda was the medication that was most mailed back followed by Tarceva.

There were a total of twenty potentially different medications disposed of, the majority of which were oncological medications. There was one unknown medication in which a respondent requested an extra envelope for. Table 3 lists the medications by category. Chart 5 displays the methods used by respondents to dispose of medications as stated within the survey. According to the third-party disposal company, forty-seven envelopes were returned for disposal, producing about a 94% return rate. The total weight of these medications was about ten pounds.

Discussion Report on the success of the project: From a customer service standpoint, providing medication disposal envelopes for patients of Avella Specialty Pharmacy was a success.

Patients responded positively to the offer of medication disposal envelopes.

More than half of patients who were offered an envelope during the months of July 2013 to January 2014 accepted the offer. Encouragingly, every patient who received an envelope indicated during the survey that they used it to dispose of their left over medications. This feedback is

Spring 2014 • Arizona Journal of Pharmacy • 15

Featured Article Medication Mail-Back Program (continued from page 15) especially interesting as 41% of responses were to use the toilet or garbage to dispose of medications and 74% of respondents had not heard of a medication disposal program before the survey call. Other methods of disposal that patients used as elucidated by the survey are: keeping them for later use, giving them to their doctor, giving them to their pharmacy or disposing of them through the DEA’s National Prescription Take-Back Day. Of the people who agreed to be surveyed, the majority of patients strongly agreed that the disposal envelopes were both helpful and easy to use. Many patients responded with enthusiasm while expressing appreciation for the service.

Many patients made comments during the survey regarding how they enjoyed using the envelope as opposed to the trash or toilet. Nine extra envelopes were mailed out to patients who requested them for other unused medications (besides the medication called about during the refill call) including the unknown medication tracked by the survey. Based on the results of the survey and comments made by patients during phone calls, it appears that patients of Avella Specialty Pharmacy are receptive to the service and the envelopes can replace other methods of disposal like using the trash or toilet.

Specialty Pharmacy and disposal of oncology medications: Avella Specialty Pharmacy deals with many specialties including rheumatology, dermatology, transplant, and infectious disease. The majority of disposal envelopes, however, were used to dispose of oncology medications. Among these specialties, oncology seems to lend itself to requiring a form of medication disposal due to the multiple reasons for discontinuing therapy. Reasons for disposal, as indicated by respondents, included discontinuation of therapy for another drug, a different dose, or due to adverse effects.

The medication disposal envelopes provided a method for disposal that did not require exposure of kids, pets, and the environment to unused oncology medications. Although some oral oncology medications that Avella Specialty Pharmacy dispenses have disposal requirements by the manufacturer, many do not. Given that

Phone Survey Results: responses from Avella patients who received a medication mail-back envelope Survey Parameter:

Total number of distinct persons who were offered an envelope Total number of distinct persons who were offered an envelope and declined offer Total number of distinct persons enrolled to receive an envelope (participants) Total number of surveys completed Total number of “yes” responses to conducting the survey Total number of “no” responses to conducting the survey Number of patients that included other medications in the envelope other than what Avella inquired about Number of patients who have not previously heard of a disposal program Number of patients who think the envelope was “helpful” Number of patients who think the envelope was “easy” to use Number of patients who would otherwise normally dispose of medications in the trash or toilet Total number of envelopes mailed out to participants Total number of participants who returned an envelope with medications to dispose Age range

Quantity

%

86

---

36

42%

50

58%

43 34

--79%

9

21%

5

15%

25

74%

33

97%

34

100%

13

38%

59

---

47

94%

40-91

Table 2

Disposed Medications Organized By Category Oncology: breast, pancreatic, renal, Afinitor transplant Cyclosporine Rheumatology/Dermatology, transplant Exemestane Oncology: breast Exjade Oncology: iron chelating agent, supportive Gleevec Oncology: chronic myeloid leukemia (CML) Hycamptin Oncology: ovarian, small lung cancer Imbruvica Oncology: lymphoma Inlyta Oncology: renal Mechlorethamine Oncology: nitrogen mustard Prednisone Oncology: supportive agent Sprycel Oncology: CML Tarceva Oncology: NSCLC, pancreatic Tafinlar Oncology: melanoma Targretin Oncology: t-cell lymphoma Tasigna Oncology: CML Temodar Oncology: astrocytoma, glioblastoma Votrient Oncology: renal, sarcoma Xeloda Oncology: colorectal, breast Xtandi Oncology: prostate Zytiga Oncology: prostate Table 3

16 • Arizona Journal of Pharmacy • Spring 2014

Featured Article Medication Mail-Back Program (continued from page 16) many unused oncology medications are considered hazardous waste and can be potentially harmful, the service potentially prevented twenty distinct medications from improper disposal and prevented exposure to vulnerable populations inside the home.

Further, the service informed patients regarding reasons for proper disposal and provided awareness about an easy, helpful alternative disposal method.

Limitations: There were several limitations to the project. The patients of Avella Specialty Pharmacy may already be accustomed to the mail-order process including utilizing the phone and mail for all pharmacy interactions. Results based on this type of participant may not reflect the results based on patients who may not already be accustomed to dealing with mail-order pharmacies. Specifically, a mail order program through a retail pharmacy may produce different results.

Another limitation is the reliance on memory in order to answer the questions of the survey. Patients may not have remembered if they heard about a disposal program before. In some cases, some patients did not remember if they placed multiple medications into the envelope.

There was one respondent who did not remember requesting an envelope.

Although all respondents indicated that they used the envelope to dispose of medications, three envelopes were not received for disposal. Limitations to this method include possibly losing medications through the mail.

Conclusion After conducting the project over the course of about seven months from July 2013 to January 2014, the results support providing medication disposal envelopes as a useful service in the setting of mail-order, specialty Pharmacy. From the perspective of customer service, respondent comments made it evident that it is a worthy service that boosts customer satisfaction.

Conflict of Interest Statement The Take Away™ medication disposal envelopes were funded by a grant from the National Community Pharmacists Association (NCPA).

References 1. Grasso, C et al. Local Hazardous Waste Management Program. (2009). Secure medicine return in washington state, the ph:arm pilot.

Available at: www.medicinereturn.com/resources2.

2. Gray J. Prescription drug abuse and DEA sanctioned drug take-back events: characteristics and outcomes in rural Appalachia. Arch Intern Med. 2012; 172:1186-87.

3. Abrons J, Vadala T, Miller S, and Cerulli J. Encouraging safe medication disposal through student pharmacist intervention. J Am Pharm Assoc.

2010; 50:169-73.

4. Seehusen DA, Edwards J. Patient practices and beliefs concerning disposal of medications. J Am Board Fam Med 2006;19:542-7.

5. Safe Kids Worldwide; c2012. Safe storage, safe dosing, safe kids: a report to the nation on safe medication. Available at: http://www.safekids.org/ assets/docs/safety-basics/safety-tips-by-risk-area/ medicine-safety-study-2012.pdf.

6. Department of Health and Human Services, Center for Disease Control and Prevention and National Institute for Occupational Safety and Health. NIOSH list of antineoplastic and other hazardous drugs in health care settings 2010.

7. Kaye L, Crittenden J, Gressit S. Reducing drug misuse through the use of a citizen mail-back program in Maine. Safe Medicine Disposal for ME: A Handbook and Summary Report. April 2010.

8. Report on San Francisco Bay Area’s Safe Medication Disposal Days. Bay Area Pollution Prevention Group 2006.

9. Safe Medication ASHP. Preventing Accidental Poisonings. Available at: http://www.safemedication.com/safemed/ MedicationTipsTools/WhatYouShouldKnow/ PreventingAccidentalPoisoning.aspx.

Disposed Medications and Frequency Medication: Xeloda

Frequency: 14

Tarceva

9

Afinitor

8

Mechlorethamine Hycamptin

4 3

Gleevec

3

Zytiga

2

Sprycel

2

Exjade

2

Cyclosporine Xtandi

2 1

Votrient Unknown medication

1 1

Temodar Tasigna Targretin

1 1 1

Tafinlar

1

Prednisone Inlyta

1 1

Imbruvica Exemestane

1 1

Total number of potentially distinct medications:

20

Table 4 *Zytiga and prednisone were mailed in the same envelope.

Avella Medication Mail-back Survey Respondents and Disposal Methods 1

3

Give to a medication collection program (1)

2

Give to their doctor (2)

1

Keep for later use (1) Not had to dispose of medications before (10) Return to the pharmacy (3)

11

10

Take to the local hospital (1) Take to the police station (3) Throw into the garbage (11)

3

1

3

Throw into the toilet* (3)

Chart 5 *One respondent chose both the trash and toilet as disposal options for a total of 34 respondents.

Arizona Journal of Pharmacy • Spring 2014 • 17

Featured Article Time Marches On

by Joe Rowan, R.Ph.

Brunswig Drug was our major supplier for Flagstaff Pharmacy and we had overnight service via Greyhound and Trailways Bus lines for our pharmacy supplies. In addition we had two days per week of truck offers for our larger and front-end supplies.

A salesman from Brunswig called on us every other week to check our stock and supply us with information on specials available to us. McKesson and Phoenix Wholesale were the other drug suppliers in town and we did use all three from time to time to keep an adequate stock of merchandise.

Brunswig later became Bergen Brunswig and Phoenix Wholesale became Amfac. A gentleman by the name of John Walker was the manager of our Brunswig distributor and he was a great friend to Arizona pharmacists. John was always able to provide a helping hand to any of his accounts and he was a great booster of the Arizona Pharmacy Association.

By 1960 there were five independent pharmacies in Flagstaff and all of us did enjoy a fairly reliable local trade. Mine was aided by my location on US Route 66 where I enjoyed very good tourist traffic. We were the only store with an old fashioned soda fountain, as that was one of my basic requirements for a good drug store. Around about 1962, my old friend from Phoenix Glenn Crandall opened a sixth store in Flagstaff as the town was beginning to grow and prosper.

While our business grew steadily in downtown Flagstaff, the handwriting was on the wall that businesses were moving to the new shopping centers and downtown was noticing a drop in local trade. Coupled with this, Interstate 40 was being completed just south of town which impacted the tourist traffic. Responding to the time, in 1969 we opened a second location in East Flagstaff.

Rowan’s Pharmacy, a modern 5,000 square foot drug store, was located in the Greenlaw Village Shopping Center and included a new surgical fitting department offering braces, walkers, and other sick room supplies. We had an expanded cosmetic and gift department and, of course, twenty-five stool soda fountain.

Once again, John Walker went above and beyond to make sure Rowan’s Pharmacy was properly laid out and supplied. Our hours of operation were 8:00 am to 10:00 pm Monday through Saturday and 8:00 am to 6:00 pm on Sunday. The Rowan Clan manned the soda fountain and filled some assignments as cashier.

With my wife Mims’ efforts, our new gift department turned out to be one of the best in town and our Christmas and other holiday business was great.

Prescription business expanded considerably from our downtown location. The average price of a prescription had mushroomed to $3.75! Though we retained a core of patrons from the west side of town, the majority of our loyal customers resided in East Flagstaff. Eventually we decided to close our downtown location and concentrate on the new location, thus starting a new chapter of life in the drug store.

This is the thirteenth 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.

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

Greenlaw Shopping Center circa late 1960’s Photo courtesy of NAU Archive Library 18 • Arizona Journal of Pharmacy • Spring 2014

Featured Article

A Look Back Magneto-Electric Machine

This handsome instrument, dating from about 1880, is of English origin. The Magneto-Electric Machine is complete with coil, magnet, and two brass electrodes, all contained in a polished mahogany case. Electro-therapy became popular in about 1850 and practitioners utilized a variety of mechanical devices. Electricity was so new that established physicians found it difficult to dispute the effectiveness of the machines. Unfortunately, most of them were no more than quack contraptions and of no benefit to the patients.

by Robert E. Kravetz, MD, FACP, MACG American College of Gastroenterology

The following is a list of some of the conditions 19th century practitioners claimed would benefit from electrotherapy: appendicitis, arthritis, asthma, constipation, hypertension, insomnia, abdominal pain, obesity, and ulcers – just to mention a few.

Today, however, there are valid and justified reasons for the medical use of electricity and magnetism.

Some of these areas are cardiology for diagnosis and treatment, monitors, transcutaneous electrical nerve stimulation for chronic pain, diathermy machines for arthritis and muscular problems, and magnetic resonance imaging scanners. It would be accurate to say that electricity has come into its own and has found an acceptable place in modern medicine.

Pharmacy Time Capsules Second Quarter 2014 1989 - Twenty-five Years ago: •

•

The Medicare Catastrophic Act of 1988 was resoundingly repealed after disclosures that insurance coverage could be bought on the open market for a fraction of the surtax imposed by the government.

Epogen (Amgen) the first recombinant human erythropoetin product approved by the FDA for marketing.

1964 - Fifty Years ago: • Surgeon General Luther Terry made an announcement that cigarette smoking causes lung cancer and probably heart disease.

1939 - Seventy-five Years ago: • Joseph Lynch, a 1927 Fordham College of Pharmacy alumni, became a police office was killed disarming a bomb set by Nazi saboteurs at the World’s Fair in Flushing Meadows.

•

WW II starts, Germany invades Poland.

1914 - One hundred Years ago: • West Virginia University establishes its College of Pharmacy.

•

Franz Ferdinand, Archduke of Austria and his wife are assassinated in Sarajevo by a Serbian nationalist, the justification of World War I.

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.

Spring 2014 • Arizona Journal of Pharmacy • 19

Featured Article Treatment of Acute Acetaminophen Toxicity with Acetylcysteine: Does Route of Administration Make a Difference?

by Tamara Krekel, Pharm.D. Candidate, Midwestern University College of Pharmacy – Glendale, Class of 2014 Preceptor: Lindsay Davis, Pharm.D., BCPS Acetylcysteine has been used in the treatment of acetaminophen (APAP) overdose worldwide since the 1970s, with Food and Drug Administration (FDA) approval for use in the United States occurring in 1985 and 2004 for oral and intravenous acetylcysteine, respectively.

A proposal for a prospective randomized controlled trial to demonstrate the efficacy of acetylcysteine was submitted to the FDA in the 1970s, however the ethics behind such a trial were questioned and the FDA subsequently declined the request. Instead, the initial approval of acetylcysteine for the indication of APAP toxicity stemmed from a prospective nationwide multi-clinic open study that showed substantial benefit with its use. A literature review conducted in October 2013 revealed no prospective trials addressing this clinical question.

Therefore, it can be said that the optimal dose, route, and duration of therapy of acetylcysteine in APAP toxicity to prevent and/or treat hepatotoxicity remains unknown.1 When given in therapeutic doses, APAP is primarily metabolized through hepatic conjugation, either through glucuronidation or sulfation, where it is subsequently renally excreted.

Approximately 5% of a therapeutic dose undergoes oxidation by CYP450 enzymes to a toxic metabolite known as N-acetylp-benzoquinoneimine (NAPQI). In the presence of glutathione, NAPQI is rapidly detoxified to mercapturate and cysteine conjugates; however, in overdose situations, glutathione reservoirs are generally depleted. This depletion leads to a build-up of NAPQI, which covalently binds to hepatocytes and causes liver damage. Glutathione is synthesized from the amino acids cysteine, glutamate, and glycine. Glutamate and glycine are both present in abundance, with the availability of cysteine being the limiting step in

glutathione production. Acetylcysteine works to increase the availability of glutathione indirectly through increasing cysteine concentrations.2 Acetylcysteine is available in multiple dosage forms including an inhalation solution and an intravenous (IV) solution that can be used for the management of APAP toxicity. Mucomyst® is an inhalation solution that can be administered orally, or filtered to be administered via the IV route. Acetadote® is the only FDA-approved IV solution.

Direct medication costs are generally lower with the oral dosage form; however, when the total cost of treatment is considered, including medication costs, inpatient stay, dispensing costs, and personnel costs, intravenous treatment has been shown to be significantly more cost effective. Comparing the side effect profiles of both routes, more nausea and vomiting is associated with oral administration whereas more anaphylactoid reactions are associated with intravenous administration.3 The Rumack-Matthew nomogram (Figure 1) is a toxicity nomogram that plots acetaminophen plasma concentration versus hours after ingestion. This nomogram can be used as a guide to whether or not hepatotoxicity is probable in a given patient to guide clinicians in making the decision of whether or not to treat with acetylcysteine. It is important to note the various limitations that arise with this nomogram including that it cannot be used for patients who: (1) present greater than 24 hours after APAP ingestion, (2) present with an unknown time since APAP ingestion, (3) present with chronic APAP toxicity, (4) present with multiple APAP ingestions throughout a specified time period, or (5) present after ingesting an extended-release APAP preparation.4 For example, let us take a patient who presents with a complaint of overdose with an unknown amount of “headache medication.” The time of overdose is unknown, and the APAP level is recorded at 62 mcg/mL. AST and ALT are both within normal limits. Based on the Rumack-Matthew nomogram, our patient could be in any of the three possible categories (i.e., no hepatotoxicity, possible hepatotoxicity, or probable hepatotoxicity) depending on the actual time of ingestion.

With this information, the decision has been made to treat the patient, but the route of acetylcysteine administration has

20 • Arizona Journal of Pharmacy • Spring 2014

not yet been determined. Does route of administration make a difference?

Yarema and colleagues published a retrospective cohort study in Annals of Emergency Medicine in 2009 comparing the 20-hour intravenous and 72-hour oral acetylcysteine protocols. Data for the intravenous cohort was collected from Canadian hospitals from 1980 to 2005 and data for the oral cohort was collected from U.S. hospitals from 1976 to 1985. A total of 4,048 patients were included, with 2,086 patients being in the intravenous cohort and 1,962 patients being in the oral cohort. The primary outcome measured was hepatotoxicity, defined as a peak AST or ALT greater than 1,000 IU/L, which is generally accepted as a loose definition. Figure 2 shows the relative risk of hepatotoxicity for the intravenous cohort compared to the oral cohort based on hours from ingestion to acetylcysteine therapy. The dotted lines represent the upper and lower limits of the 95% confidence interval. The data supports the initiation of the intravenous protocol for patients treated before twelve hours post ingestion, with the risk of hepatotoxicity being significantly lower versus oral administration. For patients treated after eighteen hours post ingestion, the risk of hepatotoxicity was significantly higher in the intravenous group, supporting the initiation of the oral protocol for these patients. No significant difference was noted for patients treated twelve to eighteen hours post ingestion. It does need to be taken into consideration that retrospective records were compared to prospective data and that they were collected during different times and in different locations.5 Following the publication by Yarema and colleagues, Green and colleagues published a systematic review and metaanalysis in Western Journal of Emergency Medicine in 2013 comparing the time dependence efficacy of both intravenous and oral acetylcysteine therapy. Sixteen articles published from 1981 to 2009 were included in the meta-analysis, representing 5,164 patients. The primary outcome measured was the percent of patients who developed hepatotoxicity, defined as a peak AST or ALT greater than 1,000 IU/L, which is consistent with the definition used by Yarema and colleagues. Time from ingestion to acetylcysteine therapy was categorized dichotomously: “early administration” was defined as less

Featured Article

metabolism by the liver is taken into treatment cessation is based on clinical Acetaminophen Toxicity (continued account, only a small percentage of oral and laboratory signs and not merely from page 20) than ten hours and “late acetylcysteine becomes systemically because the protocol has been completed. administration” was defined as greater available; however, high concentrations Unfortunately, due to the ethical than ten hours, or as otherwise defined by remain in the liver. In comparison, when reasons, a prospective randomized the authors of the individual studies. No intravenous acetylcysteine is given, only controlled trial investigating oral versus significant difference in the incidence of a small percentage remains in the liver intravenous acetylcysteine therapy hepatotoxicity was discovered between References: and higher concentrations are systemically overdose is highly routes of administration. However, 1. Rumack B, Bateman in D.acetaminophen Acetaminophen and acetylcysteine dose and d available. The importance of hepatic unlikely.

The data that is currently a significant difference was seen Toxicol. 2012;50:91-98. versus systemic concentration availableand does not suggestofa paracetamol return to using between times from APAP ingestion 2. Pettie J,remains Dow M. Assessment management poisoning i unknown. The significant decrease in oral acetylcysteine for all late presenting to acetylcysteine therapy; patients 3. Toxicology Investigator Network Authorship Group.

A multi-center co hepatotoxicity seen in late presentingacetylcysteine patients; however, of I believe it does make who received earlier treatment had a intravenous for treatment acetaminophen overdose. Clin patients when oral therapy was used a stride towards providing better patientsignificantly lower chance of developing 4. Wolf SJ, Heard K, Sloan EP et al. Clinical policy: critical issues in the m cannot be attributed solely to the route, care in the realization hepatotoxicity. Several limitations need emergency departmentcentered with acetaminophen overdose.that Ann Emerg Med. 20 as the total dose is higher than the treatment acetaminophen overdose to be taken into consideration when 5. Yarema M, Johnson D, Berlin of R et al. Comparison of the is20-hour intra intravenous route as well.

The benefit merely oneacetaminophen size fits all andpoisoning. multiple Ann Emerg analyzing the results of the study. With protocols for the treatment of not acute J, Heard K et al. to Oral intravenous acetylcysteine seen could be due to6.theGreen increased dose,K, Reynolds variables need be and taken into account any meta-analysis, individual studies may a systematic review and meta-analysis.

West J Emerg first pass metabolism producing higher when choosing a treatment routeMed. and 2013;15:218-2 be subject to publication bias and patient hepatic concentrations, or the increased duration. level data is not available, therefore 4 Figure 1. Rumack-Matthew duration provided by the oral protocol.1, 6 nomogram confounding variables cannot accurately References: Taking this new information be accounted for. In addition, none of the 1. Rumack B, Bateman D. Acetaminophen and into account, what would be your studies included were a direct comparison acetylcysteine dose and duration: past, present and recommendation for the patient discussed future. Clin Toxicol. 2012;50:91-98. between the intravenous and oral routes.

2. Pettie J, Dow M. Assessment and management earlier? The time of overdose being It is important to note that these findings of paracetamol poisoning in adults. Nurs Stand. unknown essentially translates into an cannot be directly compared to the study 2013;27:39-47 unknown risk of hepatotoxicity based on completed by Yarema and colleagues due 3. Toxicology Investigator Network Authorship Group. A multi-center comparison of the safety to their evaluation of time on a continuous the Rumack-Matthew nomogram. If the of oral versus intravenous acetylcysteine for patient were to receive the oral protocol, scale rather than as a dichotomous treatment of acetaminophen overdose. Clin Toxicol. a commitment to at least 72 hours of variable.6 2010;48:424-430. therapy would need to be made. At the Both of the studies presented compare 4. Wolf SJ, Heard K, Sloan EP et al. Clinical References: same time, a slight benefit in preventing policy: critical issues in the management of treatment protocols that differ both in 1. Rumack B, Bateman D. Acetaminophen and acetylcysteine dose and duration: past, present and future.

Clinto the emergency department patients presenting hepatotoxicity has been shown should our route andToxicol. duration, therefore, impeding 2012;50:91-98. with acetaminophen overdose. Ann Emerg Med. patient be considered “late in presenting.” the ability to determine variable 2. Pettie J, Dow M. which Assessment and management of paracetamol poisoning adults. Nurs If Stand. 2007;50:292-313.

2013;27:39-47 the patient to receivecomparison the intravenous influences the outcomes that were 3. Toxicology Investigator Network Authorship Group. were A multi-center of the safety of oralM,versus 5. Yarema Johnson D, Berlin R et al. acetylcysteine for treatment ofprotocol, acetaminophen overdose. ClinofToxicol.

2010;48:424-430. the commitment minimal Comparison of the 20-hour intravenous and 72-hour seen. If intravenous both protocols are followed as 4. Wolf SJ, Heard et al. Clinicaltreatment policy: critical issuesisinshorter, the management of patients presenting to the oral acetylcysteine protocols for the treatment of duration at 21 hours; approved per the FDA,K, theSloan oral EP protocol emergency department with acetaminophen overdose. Ann Emerg Med. 2007;50:292-313. acute acetaminophen poisoning. Ann Emerg Med. however, the completion of one protocol provides 1330 mg/kg total dose, which 5. Yarema M, Johnson D, Berlin R et al. Comparison of the 20-hour intravenous and 72-hour 2009;54:606-614. oral acetylcysteine may notpoisoning. be sufficient therapy.

Both is approximately 4.5the times the amount 6. Green J, Heard K, Reynolds K et al. Oral protocols for treatment of acute acetaminophen Ann Emerg Med. 2009;54:606-614. treatment options would befor appropriate and intravenous acetylcysteine for treatment of provided by theJ, intravenous protocol 6. Green Heard K, Reynolds K et al. Oral and intravenous acetylcysteine treatment of acetaminophen toxicity: acetaminophen toxicity: a systematic review and a systematic review and meta-analysis.

Med. 2013;15:218-226. forJ Emerg this patient as long as the decision for (300 mg/kg total dose).

When first pass West Figure 1. Rumack-Matthew nomogram4

meta-analysis. West J Emerg Med. 2013;15:218226.

Figure 2. Relative risk of hepatotoxicity for the intravenous Figurecompared 2. Relative riskoral of hepatotoxicity for the intravenous cohort compared to th cohort to the cohort5

Figure 2. Relative risk of hepatotoxicity for the intravenous cohort compared to the oral cohort5 Spring 2014 • Arizona Journal of Pharmacy • 21

Drug Information Question

What evidence is available comparing exenatide once weekly (Bydureon®) to exenatide twice daily (Byetta®)?

by Taylor Jackson, Pharm.D. Candidate, and Stacy L. Haber, Pharm.D., Associate Professor, Midwestern University College of Pharmacy-Glendale

Answer: Introduction Type II diabetes mellitus (DM2) is a complex endocrine disease characterized by hyperglycemia, insulin resistance and relative impairment in insulin secretion.1 Its incidence increases with higher degrees of obesity; in addition, excess abdominal weight causes insulin resistance. It is also frequently accompanied by hypertension and dyslipidemia.2 The longterm consequences of chronic diabetes are macrovascular and microvascular and include heart disease, stroke, kidney failure, non-traumatic lower-limb amputations and new cases of blindness.3 In the United States, it is estimated that 25.8 million people have diabetes. Seven million of these cases are undiagnosed, and an additional 79 million people have prediabetes. In 2012, the total economic cost of DM2 was approximately $245 billion, $69 billion of which was due to indirect costs from disability and early mortality.4 The current focus of clinical management is to maintain blood glucose at or near normal physiological levels to prevent microvascular disease and to aggressively treat cardiovascular risk factors to prevent macrovascular complications.1 There are many options for the management of DM2. The current American Association of Clinical Endocrinologists (AACE) guidelines suggest metformin as a first-line treatment, but are flexible to account for interpatient differences.5 Agents typically used after metformin include sulfonylureas and basal insulin, which are effective at lowering HbA1C, but associated with weight gain and hypoglycemic incidents.1,5 Thiazolidinediones are also effective, but associated with weight gain, fluid retention, bone loss and possibly other serious adverse effects. Dipeptidyl peptidase-4 inhibitors are only modestly effective, but well tolerated. Alpha-glucosidase inhibitors are also modestly effective, but poorly tolerated due to significant gastrointestinal effects. Sodium-glucose co-transporter 2 inhibitors are moderately effective, but associated with increased genitourinary complications. Glucagon-like peptide-1 (GLP-1) agonists, including exenatide, are also suggested as a possible first-line or secondary add-on treatment by the AACE. Exenatide is a biosynthetic GLP-1 analog derived from the saliva of the Gila monster; it shares 50% amino acid homology with GLP-1 and exerts its effects via agonism of the receptor.2,6 GLP-1 is secreted by the small intestine in response to oral nutrition. Its main effects are stimulating glucose-dependent insulin release from the pancreas, slowing gastric emptying, inhibiting unnecessary post-meal glucagon release and reducing food intake. GLP-1 agonists are a relatively new class of antidiabetic agents. Because of this, the risks and benefits are unclear. In 2005, exenatide twice daily was FDA approved for use as an adjunct to diet and exercise for the treatment of DM2.7 The half-life of exenatide is relatively short at about 2 hours, resulting in the need to administer it twice daily.2 In 2009, a once-weekly formulation was approved.8 In a search of Medline, 2 trials were identified that compared the safety and efficacy of 22 • Arizona Journal of Pharmacy • Spring 2014

exenatide once weekly to twice daily.9,10 In addition, 1 trial was identified that compared the treatment satisfaction and quality of life (QOL) of patients using both formulations.11 Clinical Trials In an open-label, non-inferiority study, Drucker et al.9 compared the efficacy and safety of exenatide once a week (QW) to exenatide twice a day (BID) over 30 weeks. If non-inferiority was found, a test of superiority was to be conducted. Eligible patients were required to have been treated for DM2 for at least 2 months, have a HbA1C of 7.1 to 11% and be weight stable. Randomization was stratified by the concomitant use of a sulfonylurea and HbA1C (<9% or >9%).

All patients underwent a 3-day lead-in with exenatide 5 mcg BID administered subcutaneously and then began their assigned regimen. One group received exenatide 2 mg QW, while the other continued with exenatide 5 mcg BID for another 28 days and then increased to 10 mcg BID for the remainder of the trial.

The primary endpoint was the change in HbA1C at 30 weeks.

Safety and tolerability were examined as secondary endpoints, as well as weight, blood glucose and lipids. Of the 303 patients randomized, 258 completed all 30 weeks of treatment (130 in QW, 128 in BID). At completion, the mean difference in the HbA1C change between the groups was -0.33 favoring QW (95% CI, -0.54 to -0.12). The HbA1C reduction from baseline was 1.9% for QW and 1.5% for BID (p=0.0023). A nonsignificant trend toward weight loss was observed in both groups, with a change of -3.7 kg in QW and -3.6 in BID (95% CI, -1.3 to 1.1).

Fasting plasma glucose (FPG) values changed by -41 mg/dL in the QW group and -25 mg/dL in the BID group (95% CI, -23 to -9 mg/dL). Significantly greater reductions from baseline were noted in mean total cholesterol and LDL in the QW group.

Nausea (26.4%) and injection-site pruritus (17.6%) were the most common side effects in the QW group. The BID group experienced nausea (34.5%) and vomiting (18.6%). The nausea in both groups was typically mild, with no severe cases reported in the QW group. The authors concluded that exenatide QW produced better glycemic control than exenatide BID. In a subsequent open-label, comparator-controlled study, Blevins et al.10 compared the efficacy and safety of exenatide QW to exenatide BID over 24 weeks. Eligible patients were at least 18, had been treated for DM2 for at least 2 months and had a HbA1C of 7.1 to 11%, a FPG of <280 mg/dL and a BMI of 25 to 45 kg/m2. Patients were randomized to either exenatide 2 mg QW without a titration schedule or exenatide 5 mcg BID for 4 weeks and then 10 mcg BID for the remaining 20 weeks.

Randomization was stratified by the concomitant use of a sulfonylurea and HbA1C (<9% or >9%). The primary endpoint was the change in HbA1C from baseline to week 24. Secondary endpoints included weight, FPG, blood pressure, lipids, safety and tolerability. In total, 254 patients were randomized and 204 completed through at least week 20 (109 in QW, 95 in BID). At

Drug Information Question (continued from page 22) week 24, the least squares mean change in HbA1C from baseline was -1.6% in QW and -0.9% in BID (p<0.0001). The mean HbA1C at week 24 was 7.1% in QW (baseline 8.5%) and 7.7% in BID (baseline 8.4%). FPG values changed by -35 mg/dL in the QW group and -12 mg/dL in the BID group (p=0.0008). Both groups experienced progressive weight loss through the end of the study, with a difference of -0.95 kg favoring QW (p=0.01).

In the QW group, a significant change in systolic blood pressure (-2.9 mm Hg) as well as mean fasting total and LDL cholesterol (-15.4 mg/dL and -6.4 mg/dL, respectively) were observed. The most common adverse effect in both groups was nausea (14% in QW, 35% in BID); it was typically mild and transient, with the incidence decreasing over time. Injection-site reactions were more common in the QW group (13% vs 10%) and included erythema, pruritus, rash and urticaria. The incidence of serious adverse events was low, occurring in 3 patients in the QW group (2%) and 4 in the BID group (4%); 1 patient in the QW group with a history of dyslipidemia was withdrawn due to pancreatitis.

The authors concluded that in patients with DM2, exenatide QW resulted in superior glycemic control with less nausea compared to exenatide BID. Building upon the first study mentioned, Best et al.11 assessed the treatment satisfaction and weight-related QOL in patients with DM2 treated with exenatide QW or exenatide BID for a year. The data for this study were obtained from the patient population in the trial by Drucker et al. and its follow-up study, in which all patients in the BID group were switched to exenatide 2 mg QW.12 The new QW group was followed with the original QW group using the same endpoints for a total of 52 weeks. Treatment satisfaction was assessed using the Diabetes Treatment Satisfaction Questionnaire-status version (DTSQ-s), while weight-related QOL was assessed using the Impact of Weight on Quality of Life-Lite (IWQOL-Lite). The study involved 295 patients who had received at least 1 exenatide injection (148 in QW, 147 in BID). At week 30, both groups had significant improvements in total DTSQ-s scores (p<0.001) and all individual questionnaire items, except for perceived hypoglycemia in both groups and treatment convenience in the BID group. From week 30 to 52, patients who switched from BID to QW had significant DTSQ-s improvements in total satisfaction, convenience and satisfaction with continuing treatment. Both groups had further significant improvements in treatment convenience and flexibility. All significant improvements from baseline to week 30 remained significant at week 52. At week 30, IWQOL-Lite total scores and subdomains had improved significantly in both groups (p<0.001), with effect sizes for change of 0.96 in the QW group and 0.82 in the BID group. However, there were no significant differences between the groups. At week 52, the group who switched from BID to QW had additional significant improvements in physical function and public distress. The original QW group also had additional significant improvement in public distress. All improvements from baseline to week 30 remained significant at week 52.

The authors concluded that in patients previously treated with diet and exercise and/or oral diabetic medications, exenatide resulted in significant improvements in treatment satisfaction and weight-related QOL. Furthermore, additional improvements in convenience and overall treatment satisfaction were experienced in patients who switched from BID to QW regimens.

Some limitations were noted in these studies. All involved

open-label designs, which was unavoidable, but could potentially influence patient expectations or adherence behaviors. The studies by Drucker et al. and Best et al. were also limited by lack of long-term data. Additionally, they enrolled a low proportion of minorities, potentially decreasing the generalizability of the results. Lastly, the study by Best et al. could have been strengthened with a crossover design to determine order effects on treatment satisfaction.

Discussion These trials present valuable evidence to support the theory that continuous GLP-1 agonism results in greater suppression of fasting glucagon, leading to better control of FPG. In the studies

by Drucker et al. and Blevins et al., fewer gastrointestinal adverse effects were observed in the weekly exenatide group, supporting the theory that a gradual increase in plasma drug levels may decrease the incidence of these effects. The study by Blevins et al. increased the robustness of these conclusions by repeating the same trial conditions as Drucker et al., without a weekly dose lead-in titration and in a more generalizable population. The satisfaction assessment by Best et al. confirmed that patients prefer a weekly over a twice-daily medication. In clinical practice, the increased convenience of a weekly regimen could also be beneficial in improving patient adherence.

There are a few other considerations with exenatide. Per the package inserts, use of both formulations should be avoided in patients with a creatinine clearance of <30 mL/min, gastroparesis or a history of pancreatitis.7,8 Postmarketing reports have found an increased international normalized ratio in patients on concomitant warfarin; thus, close monitoring is recommended when initiating or adjusting exenatide. In addition, exenatide QW carries a black box warning that its use should be avoided in patients with a personal or family history of medullary thyroid cell carcinomas.8 The other GLP-1 agonist currently available is liraglutide (Victoza®).6 It has been shown to reduce HbA1C by 1 to 1.5% over 26 to 52 weeks and is also associated with a significant decrease in weight of -1.4 to -3.5 kg.6,10 In contrast to exenatide, liraglutide is administered on a daily basis, is not renally adjusted and has no reported interaction with warfarin.13 However, it carries the same black box warning as exenatide QW and is associated with similar adverse reactions at higher rates.6,13 In conclusion, exenatide QW is a new diabetes medication that carries the advantage of once-weekly dosing without an initial titration schedule. It is associated with less nausea and vomiting, but more injection site reactions than exenatide BID. Exenatide QW is a good option for second-line therapy due to its ability to continuously impact FPG levels, and future studies should focus on determining the long-term ramifications of around-the-clock GLP-1 agonism.

References 1. McCulloch DK. Management of persistent hyperglycemia in type 2 diabetes mellitus. In: UpToDate [Internet Database]. Basow DS, ed. Waltham, MA: UpToDate. Updated 2013 Jul 24.

2. Triplitt CL, Reasner CA. Chapter 83. Diabetes mellitus. In: DiPiro JT, Talbert RL, Yee GC et al., eds. Pharmacotherapy: a pathophysiologic approach.

8th ed. New York: McGraw-Hill; 2011. http://0-www.accesspharmacy.com. millennium.midwestern.edu/content.aspx?aID=7990956. Accessed September 10, 2013.

3 Centers for Disease Control and Prevention. National diabetes fact sheet: national estimates and general information on diabetes and pre-diabetes in the United States, 2011. Atlanta, GA: U.S. Department of Health and Human Services, 2011.

Spring 2014 • Arizona Journal of Pharmacy • 23

Drug Information Question (continued from page 23) 4. Yang W, Dall TM, Halder P et al. Economic costs of diabetes in the U.S. in 2012. Diabetes Care. 2013; 36:1033-46.

5. Garber AJ, Abrahamson MJ, Barzilay JI et al. AACE comprehensive diabetes management algorithm 2013. Endocr Pract. 2013; 19:327-36.

6. Dungan FD. Glucagon-like peptide-1-based therapies for the treatment of type 2 diabetes mellitus. In: UpToDate [Internet Database]. Basow DS, ed.

Waltham, MA: UpToDate. Updated 2013 Aug 7.

7. Byetta (exenatide) package insert. San Diego, CA: Amylin Pharmaceuticals Inc; 2007.

8. Bydureon (exenatide) package insert. San Diego, CA: Amylin Pharmaceuticals Inc; 2012.

9. Drucker DJ, Buse JB, Taylor K et al. Exenatide once weekly versus twice daily for the treatment of type 2 diabetes: a randomised, open-label, non-inferiority study. Lancet. 2008; 372:1240-50.

10. Blevins T, Pullman J, Malloy J et al. DURATION-5: exenatide once weekly resulted in greater improvements in glycemic control compared with exenatide twice daily in patients with type 2 diabetes. J Clin Endocrinol Metab. 2011; 96:1301-10.

11. Best JH, Boye KS, Rubin RR. Improved treatment satisfaction and weightrelated quality of life with exenatide once weekly or twice daily. Diabet Med. 2009; 26:722-8.

12. Buse J, Drucker D, Taylor K et al. DURATION-1: exenatide once weekly elicits sustained glycaemic control and weight loss over 52 weeks. Diabetes Care.

2010; 33:1255-61.

13. Victoza (liraglutide) package insert. Plainsboro, NJ: Novo Nordisk Inc; 2010.

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.

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24 • Arizona Journal of Pharmacy • Spring 2014

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Student Perspective Pharmacy Day at the State Capital 2014

by Quan Pham, Pharm.D. Candidate, Midwestern University College of Pharmacy-Glendale, Class of 2015 “It’s hard to miss the cloud of white out here.” This phrase best describes the 2014 Pharmacy Day at the State Capital, also known as PD@C, held on the Arizona Senate Lawn on Wednesday, February 12, 2014. Over a hundred pharmacy students, dressed in white coats, from the University of Arizona and Midwestern University volunteered for the event. In addition, faculty from both universities, community partners, and members of the Arizona Pharmacy Association participated.

More than 200 legislators and legislative staffers participated in the event hosted by the American Pharmacist Association Academy of Student Pharmacists and the Arizona Pharmacy Association Student Pharmacist Academy. The strategic set up told a story about the profession of pharmacy, promoting the pharmacy profession as we strive toward health care provider status. Each student group had a poster or a booth that demonstrated how pharmacists have helped or can help patients in Arizona.

First, the guests who included legislators, legislative staff members, and other visitors signed in at the registration table and were introduced to a pharmacy student who acted as a tour guide and led them around to each exhibit. Legislators had an opportunity to see first-hand the health screening services that

Do you know someone who is not a member of the Arizona Pharmacy Association . . . and should be?!

pharmacists already provide. Two screenings available were diabetes and hypertension. Guests could have their blood glucose tested and blood pressure measured by a pharmacy student.

The screenings allowed students to talk to the guests about how pharmacists and pharmacy interns are helping reduce health care cost by educating patients. Lifestyle modifications can help patients stay out of emergency rooms and reduce hospital visits if the proper amount of time is spent with the patients to guide them.

Additionally, guests were able to review poster presentations such as Impact of Immunizations on Public Health, Smoking Cessation, Issues in Community Pharmacy, and Pharmacists Role on the Health care Team. Each poster was filled with valuable information carefully arranged by the groups to promote the profession of pharmacy. For example, Impact of Immunizations provided reasons why one should be immunized, the pharmacist’s role, reduced economic costs, and dispelled myths regarding immunization. Likewise, Pharmacist’s Role on the Health care Team poster provided research that showed an overwhelming amount of physicians reported benefits of collaborating with pharmacists to improve patient care. Local community partners Fry’s Food and Drug, Safeway, and Walgreens were available to provide free flu shots for those who had not yet received one.

The last stop on the PD@C tour, Bringing it All Together, helped unify the theme as student pharmacists and pharmacists continue to advance the initiative to recognize pharmacists as health care providers.

While there are still major hurdles to overcome, as we continue to hold events like PD@C, student pharmacists are making a significant impact on how legislators see the future of the pharmacy profession.

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

Rep. Saldate has his glucose level tested.

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

William Francis, Arizona State Board of Pharmacy board member, talks with the author, Quan Pham.

Spring 2014 • Arizona Journal of Pharmacy • 25

Student Perspective Tradition and Innovation: 47th Annual Southwestern Clinical Pharmacy Seminar

by Amelia Duke, Pharm.D. Candidate, University of Arizona College of Pharmacy, Class of 2014

March 7-9th, 2014, the 47th Annual Southwestern Clinical Pharmacy Seminar was held at the Hilton El Conquistador in Tucson, Arizona. This two and one-half day seminar introducted new partnerships and contemporary components, while continuing the tradition of sharing information amongst pharmacists and technicians and addressing issues currently affecting pharmacy.

This event was unique from previous years owing to the fact that the event was developed through a partnership between the University of Arizona College of Pharmacy, the Arizona Pharmacy Association, and the AzPA Health-System Academy, the Arizona affiliate of the American Society of Health-System Pharmacists. The co-presentation brought a blend of tradition and innovation to this longstanding program, combining favorite speakers and continuing pharmacy education with a paperless event featuring online registration and USB Flash Drives preloaded with session handouts.

One new offering for this year’s event was the optional AzPA Psychiatric Certificate Program on Friday preceding the Seminar. Lisa Goldstone, Assistant Professor at the University of Arizona College of Pharmacy, along with Martha Fankhauser, Nicole Kitts, and Kristyn Straw, conducted the program providing a wonderful overview of assessing, monitoring, and managing patients with psychiatric disorders. I was impressed to see pharmacists in both non-traditional and traditional practice settings wanting to enhance their clinical knowledge on psychiatric pharmacy. I was glad to have the opportunity to participate in this program because I am and will continue to be exposed to a variety of patients which include ones with psychiatric disorders. This certification provided a good foundation for me to understand how to approach this population and address concerns that patients may be having, while shedding light on certain lay theories or negative connotations patients may have about their medications or their conditions.

There was a wealth of resources provided to participants on how to address drug interactions, pregnancy/lactation concerns, differentiating medications, and determining appropriate medication regimens. These resources will be well-referenced as I continue my pharmacy career.

The Seminar officially began on Saturday, March 8. The keynote speakers were Thomas Menighan, Executive Vice President and CEO of the American Pharmacists Association, and David Chen, Director of Pharmacy Practice Sections at the American Society of Health-System Pharmacists. We had the great opportunity to listen to each of their perspectives and understand how these national organizations are helping to drive pharmacy practices.

Tom Menighan’s presentation helped gear pharmacists to get in the game to achieve provider status. We, as pharmacists, are stronger when we maintain unity to promote a common cause because we all believe that we can play vital roles in health care. Pharmacists’ efforts to achieve provider status have received promising progress with the recent introduction of H.R. 4190 in the U.S. House of Representatives containing 26 • Arizona Journal of Pharmacy • Spring 2014

AzPA CEO Kelly Ridgway and APhA Executive Vice President and CEO Tom Menighan at the 47th Annual Southwestern Clinical Pharmacy Seminar Welcome Reception language to recognize pharmacists as providers under Medicare Part B. H.R. 4190 will help address gaps in the nation’s health care system by increasing access to pharmacists’ services in the medically underserved communities. However, the war is not yet won, we still have a long-term effort ahead to make sure this bill progresses. Be prepared to voice your opinion on provider status because pharmacists have an impact. Tom Menighan states, “Influence is something you think you have until you try to use it.”

The University of Arizona College of Pharmacy (COP) was well represented as many of the faculty members were presenters at the meeting, including Jeannie Lee (Caring for Aging Adults), Terri Warholak(Continuous Quality Assurance), Amy Kennedy (Effective, Safe Analgesia), Robert Lipsy (Tinibs, Fenibs, Flozins, and other FDA Gifts), Hanna Phan (Updates in Pediatric Asthma & Bronchiolitis), and Brian Erstad (Pharmacists as Providers).

David Lee and Robert Squire had an interactive approach as how to review the USP 797, Arizona Compounding Regulations.

They reviewed the differences among low, medium, and high risk compounding, how to apply and use appropriate alligations, and determine appropriate expiration dates for extemporaneously compounded products. Then, they concluded the course by having everyone utilize their new-found information by appropriately preparing hand sanitizer. Participants were thoroughly excited by compounding their own hand sanitizer, which, for some, rekindled their passion for science. Among the participants were our keynote speakers, Tom Menighan and David Chen, preparing their very own hand sanitizers to keep away the bugs on their journeys home.

This Seminar positively united pharmacists from different spectrums of the field to help guide them as to how they can help promote the profession of pharmacy. There was a question asked during the Antibiotic Stewardship presentation “how can I, as a community pharmacist, be able to have an impact [on antibiotic stewardship]?” This presented a very pertinent point, as many pharmacists are unaware of how they can help promote pharmacy initiatives that seem outside their realm of practice. The response was that one always has the ability to alter a patient’s perception of antibiotics. Community pharmacists can provide education to patients by informing them to be aware that antibiotics do not always solve all acute ailments. We are also able to contact the provider to see if there is a way to narrow antibiotic coverage

Student Perspective Tradition and Innovation (continued from page 26) when two or more antibiotics are prescribed but have overlapping coverage.

Therefore, it is important to note that because areas of pharmacy practice vary, we can still find ways to encourage pharmacy goals within our scope of practice. Medication use practices feature well into hospital and community models to promote continuity of care.

As a student, I was inspired by how committed pharmacists are in continuing to learn about the latest updates in health care and advancements in patient care. As health care providers, we never stop learning. No matter what age we are, we continue to seek knowledge. We had participants at the conference ranging from early 20’s to late 80’s and all of them share a similar passion for learning. Bringing together people with common interests of various ages and scopes of practice allows us to share ideas on innovations in practice models, where community and healthsystem pharmacists can discuss what they are doing in their specific fields.

The Seminar concluded with a compelling topic of current Pharmacy Case Law presented by Roger Morris. The activity allowed a greater awareness of how pharmacies and pharmacists have been involved in recent legal matters - the good, the bad, and the ugly. Morris ended the seminar with 15 reasons to date a pharmacist as published by eHarmony ending with the 15th reason being “Pharmacists make people feel better”.

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AzPA President Ray Clark talked with ASHP Director of Pharmacy Practice Sections David Chen at the Seminar.

“I’MMY ALWAYS “I’M ALWAYS FOR PATIENTS, WATCHING OUT BUT WHO’S FOR MY PATIENTS, WATCHING OUT WATCHING BUT WHO’SOUT FOR ME?” WATCHING FOR MYOUT PATIENTS, FOR ME?” BUT WHO’S “I’M ALWAYS WATCHING OUT WATCHING OUT WE ARE. FORARE. MY PATIENTS, WE FOR ME?” BUT WHO’S

We are the Alliance for Patient Medication Safety (APMS), We are the Alliance forSafety Patient Organization.

Medication Safety (APMS), a federally listed Patient

OUT aWATCHING federally listed Patient Safety Organization.

Our Pharmacy Quality Commitment (PQC) program: • • •

FOR ME?” Helps you implement and maintain a continuous quality improvement

Our Pharmacy Quality Commitment (PQC) program: •

Helps you implement and maintain a continuous quality improvement program program Offers federal protection for your patient safety data and your quality • Offers federal protection for your patient safety data and your quality improvement work improvement work Assists withwith quality assurance foundininnetwork networkcontracts, contracts, • Assists quality assurancerequirements requirements found Medicare PartPart D, D, and state Medicare and state regulations regulations •Provides Provides tools, training tools, training We are the Alliance for Patient Medication Safety (APMS), and support to keep your Safety Organization. support to keep your aand federally listed Patient pharmacy running efficiently pharmacy running efficiently Our and Pharmacy Quality patients safe Commitment (PQC) program: and youryour patients safe

WE ARE.

WE ARE.

•

We are the Alliance for Patient Medic Call toll free (866) 365-7472 or visit www.pqc.net Call toll free (866) 365-7472 or visit www.pqc.net a federally listed Patient Safety Organ •

AzPA Member James Morrison, Sr. of Tucson attended the Seminar with his son James Morrison, Jr., a pharmacist from Redlands, California.

Helps you implement and maintain a continuous quality improvement program • Offers federal protection for your patient safety data and your quality improvement work •PQCAssists with quality assurance requirements found in network contracts, IS BROUGHT TO YOU

BY YOUR STATE PHARMACY ASSOCIATION PQC IS Medicare BROUGHT TOD,YOU

BY YOUR STATE PHARMACY ASSOCIATION Part and state regulations Spring 2014 • Arizona Journal of Pharmacy • 27 • Provides tools, training and support to keep your

Our Pharmacy Quality Commitment (PQ

Academy News Community Practice Academy This last quarter, the academy executive committee had two conference calls. We have had a lot of success in our efforts to welcome all new members with a phone call. Our Membership Committee Representative Ashley Kalchthaler has been diligently calling each new member. To date, she has done most of the calls herself, but she is looking for some help with the phone calls.

Thank you, Ashley. If you are willing and able to make three to five phone calls a month to welcome our new CPA members, please contact me or Ashley.

The majority of this past quarter has been spent working on coming up with new faces to represent Community Pharmacy on the Board of Directors. After lots of conversations with many viable candidates, we have recruited two wonderful, qualified, and energetic candidates. We can hardly wait for everyone to find out who our nominees are.

Grace Akoh-Arrey, CPA Chair-elect, and I are still working on the Academy handbook. To keep our membership up to date on the latest news and events we plan to have our Communications Commitee Representative circulate a newsletter. Hopefully we will have some final ideas ready for the July report.

I am happy that we have accomplished the goal of seating an entire, active executive board for the Community Pharmacy Academy, and hope that members will continue to volunteer their precious time to AzPA. I look forward to seeing many of you at the AzPA Convention at the Wigwam Resort in Litchfield Park this June. .

Betty Louton, Pharm.D. Community Pharmacy Academy Chair cpa@azpharmacy.org

Geriatric Care Academy 2014 has started off with a bang for the GCA. We have continued our monthly conference calls on the second Wednesday of each month at 12 noon. These calls have included increased participation from several members and we now have a full executive committee. I would like to thank everyone for their participation.

The GCA participated in a service event on December 13th and 14th, 2013. This event, the Arizona Mission of Mercy, was a dental clinic that provided over 2,200 people with over $1.4 million of free dental care. The GCA recruited four of its members to staff the pharmacy area along with the pharmacy lead, Katrina Ramsey. We also recruited 28 Midwestern University pharmacy students to help with the event. The pharmacy volunteeers were responsible for counseling and dispensing antibiotics along with pain medications.

Thank you to everyone who participated in this important service activity.

As part of a new partnership with The University of Arizona College of Pharmacy, the AzPA GCA contributed to the 47th Annual Southwestern Clinical Pharmacy Seminar held in March in Tucson. Jeannie Lee presented Caring for Aging Adults: Maximize Impact with Latest Guidelines. We are also involved in the initial stages of planning the annual convention that will be held this summer in Litchfield Park. If anyone has any topic suggestions for the convention, please feel free to contact me.

As always, if you are interested in 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

28 â&#x20AC;˘ Arizona Journal of Pharmacy â&#x20AC;˘ Spring 2014

Academy News Health-System Academy News “Spring is the time of plans and projects.” ― Leo Tolstoy, Anna Karenina What a busy time for the HSA. Hopefully many of you were able to participate in the 47th Annual Southwest Clinical Pharmacy Seminar. This was our first time co-presenting this event with The University of Arizona and it proved to be quite successful. Thank you to Mitch Buckley, HSA Conference Planning Chair and all who planned the content. Thank you to Emily Lundeen and Heather Leinbach for coordinating the poster session. Thank you to all our fabulous speakers and poster presenters. Way to represent AzPA and the HSA! Watch for information about upcoming New Practitioner events in both Phoenix and Tucson. We are looking forward to meeting you and any colleagues you bring along.

We are looking for a few good members who are interested in joining the HSA Executive Board. If you have an interest in taking your membership ‘to the next level’ or getting more involved, please consider us. Some positions take as little as 1-2 hours of time commitment per month, but have a large impact on the Academy and the Association. We have positions for all types of interest, from education to planning new member events to maintaining membership. If you have any questions or are interested in joining the board, please contact us at hsa@azpharmacy.org.

Spring is a time for growth and HSA continues to bring new ideas to life. Thank you for your participation. I hope to see you all at the AzPA Annual Convention in June.

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 was well-represented at the 47th Annual Southwestern Clinical Seminar in Tucson in March. The Seminar included a continuing pharmacy education activity on Medication Adherence: A Patient-Centered Approach. Kennet Kelly, Pharm.D., from Cigna Medical Group, and Tina Bauman, R.Ph., from Express Scripts, Inc. co-presented the session which was wellattended. Other CE activities included Continuous Quality Assurance and Pharmacists as Providers, topics very timely as legislation to recognize pharmacists as providers has been introduced on both the national and state levels.

Registration is now open for the 2014 AzPA Annual Convention at the Wigwam in Litchfield Park June 26th to 29th. The theme of the conference is Pharmacists as Providers: Changing the Game. MCA’s own Ann Sears will be installed as AzPA President. Please plan to attend.

Thank you to Ann Sears for coordinating student pharmacist volunteers from Midwestern University and University of Arizona for the Annual American Diabetes Association Tour de Cure events in Tucson and Phoenix this past March.

The next Managed Care Academy conference call is Thursday, April 16, 2014 at 7:00 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 Spring 2014 • Arizona Journal of Pharmacy • 29

Academy News Student Pharmacist Academy News AzPA CEO Kelly Ridgway spoke to student pharmacists at both The University of Arizona and Midwestern University about Pharmacy Day at the Capitol and what to expect. Students received information on important issues currently in pharmacy, including pharmacists as providers. Pharmacy Day at the Capitol had a great turn out of students with several booths from many student organizations educating the public and our district representatives on the roles of pharmacists. See the Student Perspective article on page 26.

Last semester U of A students piloted an osteoporosis screening program to add to the University of Arizona’s health fairs. The tool utilizes FRAX to predict risk of osteoporotic fractures as well as dietary education relating to calcium and vitamin D intake. This program will be offered at five health fairs this semester including one at the Tucson Chinese Cultural Center.

Future plans include having our Katy’s Kids organization go to an elementary school to talk to the kids about basic medication safety and the potential danger of prescription drug abuse. Students on the AzPA board are also planning to staff an information booth at the local community college to promote the importance of taking vitamins for young women as part of the PowerMe A2Z campaign.

Midwestern students started off this quarter providing volunteers for the American Diabetes Associations Forum held at the Mesa Community Center. Students provided BMI screenings and had the opportunity to educate members of the community on good nutrition and healthy lifestyle changes.

The students at Midwestern hosted a health fair on March 7th from 8:30 am - 11:00 am at the Glendale Adult Center with posters on various health topics.

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 The Technician Academy is excited to announce a new feature in the Arizona Journal of Pharmacy – the Technician Spotlight (see page 12.) Each issue will feature an AzPA Technician Member Thank you to Kalani Anderson, C.Ph.T., for coordinating this project and authoring the first Spotlight. If you have suggestions for future Spotlight subjects, please contact us a tech@azpharmacy.org We still need technician representation for the Community Pharmacy Academy, Health System Academy, and Annual Convention Steering Committee. Please let us know if you can participate as a representative of the Technician Academy.

Congratulation to Josh Kramer on his new position as Director of Education Arizona College of Allied Health. Judi Day will be replacing Josh Kramer on the Membership Committee.

The Academy is currently working on the Technician Premium AzPA membership and will submit to the Board for approval. We are also looking for ideas for potential certificate programs for technicians and any ideas would be welcome.

Reg Roy and Judi Day will visit various Technician Schools to inform new technicians of activities and benefits of AzPA Membership.

All members of the AzPA Technician Academy are invited to join our monthly calls. The next call is Wednesday, April 9, 2014 at 7:00 pm. Please plan to join us.

Judi Day, C.Ph.T Technician Academy Chair tech@azpharmacy.org

30 • Arizona Journal of Pharmacy • Spring 2014

Continuing Education

From A to Z: Clinical Pearls for the Acute Care Pharmacist. Part 1.

“Rare Diseases Electronic Resources, Nuclear Materials Exposure, Alternative Thrombolytic Administration in Pulmonary Embolism”

by Mindy (Throm) Burnworth, Pharm.D., BCPS, Midwestern University College of Pharmacy-Glendale, Glendale, AZ, Associate Professor, Department of Pharmacy Practice; Scott Hall, Pharm.D., John C. Lincoln Hospital, Phoenix, AZ, Emergency Department Clinical Pharmacist; Stephen Perona, PharmD, BCPS, Northwest Medical Center, Tucson, AZ, Emergency Department Pharmacist Goal This home-study continuing education activity was developed to educate acute care pharmacists on several “clinical pearls” that are applicable in day-to-day patient care.

Objectives 1. Define the concept of a “clinical pearl” 2. Evaluate rare disease resources such as the Canadian Organization for Rare Disorders (CORD), Rare Diseases Europe (EURORDIS), Genetic and Rare Diseases Information Center (GARD), and National Organization for Rare Disorders (NORD) 3. Discuss medications unique to hazardous nuclear materials exposure 4. Identify patients who may benefit from rapid infusion of thrombolytics for confirmed pulmonary embolism Background: This continuing education article was written directly from the transcripts of the live continuing education symposium, “From A to Z: Clinical Pearls for Pharmacists,” that was presented at the Arizona Pharmacy Association Annual Convention and Tradeshow on June 28, 2013 at the Westin La Paloma in Tucson, Arizona. This article will serve as the first of a series of written summaries from the live program. Portions of the information included in this article are represented in the published literature, while the remainder reflects opinions of the presenting faculty, based on their clinical experience. As defined by Canaday’s Clinical Pearls (2009, Bethesda, MD: American Society of Health System Pharmacists [ASHP]) a “clinical pearl” is intended to convey one idea, concept, fact, or other information that a clinician has found useful in day-to-day patient-care, but may not be widely known, understood, published, or taught.1

Clinical Pearl 1: “R.A.I.D. Kills Bugs Dead” But What About Patients?

A Primer on Rare And Interesting Diseases Electronic Resources by Mindy (Throm) Burnworth, Pharm.D., BCPS In the United States, a rare (or orphan) disease is defined as any disorder affecting less than 200,000 persons.2,3 Currently a limited number of medications or orphan drugs are used off label for treatment of a mere few hundred of the nearly 7,000 rare diseases nationwide.4,5 While each individual disease may be rare, when considered as a whole these diseases affect over 30 million Americans.2,3 Porphyria, a genetic disorder of heme biosynthesis characterized by acute life-threatening attacks of neurologic symptoms, is classified as a rare disease.6 The orphan drug, hemin for injection (Panhematin), provides treatment for an acute exacerbation of this rare disease and can total $8,000 for a standard 4-day treatment.6 Unfortunately, physician (and pharmacist) knowledge and awareness of rare diseases and corresponding treatment is limited.7 With several thousand rare diseases it would be difficult to cover all these topics in a pharmacy curriculum; however, one elective course with a focus on rare diseases is reported in the academic literature.8 In general, it may not be until clinical practice that a pharmacist encounters a rare disease or orphan drug and then “on the job” self teaching is warranted. In the time constraints of clinical practice and the need to provide safe and effective care for patients with rare diseases, it is important to be familiar with resources to assist patients with rare diseases and orphan medications.9 Four reliable and readily available electronic resources with focus on rare diseases and corresponding orphan drugs include the Canadian Organization for Rare Disorders (CORD) www. raredisorders.ca, Rare Diseases Europe (EURORDIS) www.eurordis.org, Office of Rare Diseases Research Genetic, Rare Diseases Information Center (GARD)

www.rarediseases.info.nih.gov/GARD, and National Organization for Rare Diseases (NORD) www.rarediseases. org.10,11,12,13 Adding these universal resource locators (URL) to the list of favorites on electronic devices may provide time saving assistance in practice.

Each organization’s website includes unique components that may assist the pharmacist in the management of a patient with a rare disorder.

CORD is Canada’s national network for organizations representing all those with rare disorders. CORD provides a strong common voice to advocate for health policy and a health care system that works for those with rare disorders.

CORD’s home page spotlights the most recent issue of the journal publication Rare Diseases that serves as a campaign to increase knowledge and awareness of orphan diseases and includes patient testimonials.10 In addition, a health care professional newsletter is published throughout the year that provides short reviews of rare diseases as well as research initiatives.14 EURORDIS is a non-governmental patient-driven alliance of patient organizations and individuals active in the field of rare diseases, representing 590 rare disease patient organizations in 54 countries covering over 4,000 diseases.

EURORDIS is dedicated to improving the quality of life of all people living with rare diseases in Europe.11 EURORDIS has a Facebook like component (RareConnect) to link individuals with specific rare disorders for support and information sharing.15 The GARD Information Center was created in 2002 by the Office of Rare Diseases Research (ORDR) and the National Human Genome Research Institute (NHGRI), two agencies of the National Institutes of Health (NIH), to assist individuals to find useful information about genetic and rare diseases. GARD provides timely access to experienced information specialists who provide current and accurate information about genetic and rare diseases in both

Spring 2014 • Arizona Journal of Pharmacy • 31

Continuing Education (continued from page 31) English and Spanish. GARD provides information on rare diseases not included in NORD and research studies completed or underway. The database is easily searched alphabetically, by associated orphan drug, or by category.12 NORD is a unique federation of voluntary health organizations dedicated to helping people with rare (orphan) diseases and assisting the organizations that serve them. NORD is committed to the identification, treatment, and cure of rare disorders through programs of education, advocacy, research, and service.13 Interestingly, NORD is celebrating its third decade; coincidentally, this parallels the 30-year anniversary of the 1983 Orphan Drug Act. Abbey Meyers, the founder of NORD, is considered the primary advocate responsible for the passage of this landmark act.16 NORD’s website offers the Rare Disease Database, a database that provides brief introductions to more than 1,200 rare diseases and treatments (including orphan drugs and whom to contact to procure the medication). After a short registration process, individuals have complementary access to two full reports per day. A full, paid subscription allowing unlimited daily access is also available. The rare disease with corresponding orphan drug summaries are similar to drug monographs that are found in common pharmacy drug information databases. The NORD monographs may be useful in “self teaching” about a particular rare disease and corresponding orphan drug. The clarity and precision of the monograph (two to three pages) serve as a useful resource to share with other members of the health care team.5 If available, NORD also provides links to the national organization(s) for each rare disease, corresponding patient organization database(s), and valuable resources on patient assistance program(s).

In summary, several reliable websites facilitate “on the job” self teaching about rare diseases (Table 1). Finally, dare to wear that you care! Annually on February 28, recognized as Rare Disease Day, wear a blue ribbon to raise awareness about rare diseases and their impact on patients’ lives.

Table 1: Summary of Rare Diseases Electronic Resources10,11,12,13 Organization

Electronic Database

Comments

Canadian Organization for Rare Disorders (CORD)10

www.raredisorders.ca

Rare Diseases newsletter/journal publication

Rare Diseases Europe (EURORDIS)11

www.eurordis.org

RareConnect (Facebook like component)

Genetic and Rare Diseases Information Center (GARD)12

www.rarediseases.info.nih.gov/GARD

Overview of rare diseases not included in NORD Research studies completed or underway

National Organization of Rare Disorders (NORD)13

www.rarediseases.org

Database providing brief introductions to more than 1,200 rare diseases and treatments Links to the national organization for each rare disease (if available) Patient organization database Patient assistance programs

Clinical Pearl 2: Keep Calm and Dispense On: Medications in Nuclear Materials Exposure by Scott Hall, Pharm.D. Civilian exposure to nuclear materials – either through an accident at a nuclear power facility, or something more sinister – is an often-practiced disaster scenario occurring in many major metropolitan areas. These drills focus primarily on triage and trauma management and are directed toward first responders. Although pharmacists may be asked to participate in other roles as needed during an event such as this, they will primarily serve as a resource for the dosing and utilization of specific antidotes. Many of these are not typically stocked in a hospital pharmacy, but will instead arrive as a part of the Strategic National Stockpile that is provided by the Federal Government in such a situation.17,18 This pearl will focus on the antidotes for three radioactive materials – cesium, plutonium, and iodine.

Exposure to nuclear material presents in two ways, either irradiation or contamination. Irradiation is exposure without transfer of nuclear material.

Contamination is the external and/or internal transfer of radioactive material.

External contamination can be as simple as radioactive particles landing on the skin, while internal contamination can arise from wounds, ingestion, or inhalation.19 Ferric hexacyanoferrate, more

32 • Arizona Journal of Pharmacy • Spring 2014

commonly known as Prussian blue (Radiogardase®), is an oral chelating agent used in radioactive cesium exposure.20,21 Its primary site of action is within the intestines, where it chelates with the radioactive material, which is then excreted from the body. Supplied as a 500 mg capsule, adults and adolescents should take 3 g orally three times daily; children 2-12 years of age should receive 1 g orally three times daily. The most common adverse effects include upset stomach, constipation, and blue-colored feces.

Duration of treatment is at least 30 days.

Prussian blue has historically been used as a cloth dye; though still available in many art supply stores, patients should not be advised to take this product if they suspect exposure to radioactive cesium.21 The intravenous chelation agent diethylene triamine pentaacetic acid (DTPA) is used after exposure to radioactive plutonium.22 The agent is supplied as either a calcium (Ca-DTPA) or zinc (Zn-DTPA) complex. DTPA chelates with radioactive plutonium in the blood and interstitial fluid and is then excreted renally. Though both agents are approved for this type of exposure, several caveats should be noted. First, Ca-DTPA is ten times more effective as a chelating agent within the first 24 hours of internal contamination; after this period both agents have shown equal effectiveness.

Second, Ca-DTPA has a pregnancy risk factor “C” risk rating; adverse fetal effects

Continuing Education (continued from page 32) were documented in animal studies secondary to zinc depletion. These same adverse effects were not documented with Zn-DTPA, earning it a pregnancy risk factor “B” risk rating; it is the agent of choice for the contaminated pregnant patient. Third, Ca-DTPA should be avoided in patients with a known history of hemochomatosis, as the agent can fatally deplete endogenous iron stores in this patient group.23,24 There is no difference is dosing between both Ca-DTPA and Zn-DTPA. Adults and children greater than 12 years old should receive 1 gram daily, given either IV push over 3-4 minutes or as an IV infusion over 30 minutes. Children less than 12 years old should receive 14 mg/kg daily, with dosing not to exceed 1 gram. DTPA can also be given as a nebulized solution; 1 gram of DTPA should be diluted 1:1 with sterile water or normal saline.

The patient should be advised to not swallow the expectorant produced by the nebulization treatment as it is radioactive, causing additional internal contamination.

Adverse effects include chest pain, headache, diarrhea, and depletion of endogenous trace metals. Duration of therapy depends on clinical response.23,24 Radioactive iodine poses a targeted danger to the thyroid gland, especially in children.25 Its uptake should be blocked within 4 hours of exposure, when possible, with potassium iodide. The dosing for this agent is outlined in Table 2, and should be administered once every 24 hours.

Potassium iodide is a pregnancy category D medication, which crosses the placenta and can cause hypothyroidism and goiter in a fetus or newborn. The risks and benefits should be assessed before administering to a pregnant patient. Adverse effects include nausea, vomiting, diarrhea, and cardiac arrhythmias. Potassium iodide can have clinically significant drug interactions with angiotensin-converting-enzyme inhibitors, angiotensin receptor blockers, and lithium salts.26,27,28

As previously stated, the majority of these medications are not typically stocked in a pharmacy’s inventory, and are certainly not utilized in daily practice. Websites for the Centers for Disease Control and Prevention (CDC) and the U.S. Department of Health and Human Services Radiation Emergency Medical Management (REMM) are excellent resources for all things related to radiation emergencies, including drug information.18,29 Familiarity with these sources will help pharmacists be better prepared to provide information to both health care providers and patients in emergency situations.

Clinical Pearl 3: Rapid Infusion and Bolus Dose Thrombolytic Administration in Massive Pulmonary Embolism by Stephen Perona, Pharm.D., BCPS Rapid diagnosis and initiation of appropriate treatment are critical to survival in patients with an acute Pulmonary Embolism (PE). Despite appropriate treatment mortality remains between 5-17%. In patients with shock or cardiopulmonary arrest the risk of death may be as high as 30 to 70% respectively.30,31 Patients at the highest risk of death from acute PE have the most to gain from thrombolytic therapy, but less than one-third of eligible patients receive it.32 The Food and Drug Administration (FDA) approved dosing of alteplase for PE is 100 mg over two hours. Patients with actual or imminent cardiac arrest may benefit from bolus or accelerated dosing but the optimal regimen in these patients is not well defined.31 The use of the term massive to classify the severity of PE is potentially misleading. Historically the term was used in reference to the physical size or location of the embolism. It is currently applied patients with an acute PE and hypotension, defined as a systolic blood pressure below 90 mm Hg or a sustained decrease of 40 mm Hg or greater from

Table 2: Potassium iodide dosing recommendations26,27,28 Patient Population Potassium iodide (KI) dose, mg Adults less than 40 years 130 Adults less than 18-40 years 130 Pregnant/Lactating Women 130 Adolescents, 12-18 years 65 Children greater than 3-12 years 65 Children 1 month-3 years 32* Infants birth-1 month 32* *Use of oral solution is recommended

baseline. The most recent guidelines from the European Society of Cardiology recommend replacing the terms massive and submassive with predicted mortality stratification.33 This difference becomes increasingly important when considering treatment. The only accepted criteria for thrombolytic administration is an acute PE associated with hypotension (i.e. massive PE).31 Other clinical evidence of instability including tachycardia, signs of poor perfusion, hypoxemia, failure to improve on anticoagulant therapy, and signs of right ventricular dysfunction predict increased mortality and help identify patients who will benefit from thrombolysis. In general, thrombolytic therapy should only be considered in patients with diagnostically confirmed PE, who are not at excess bleeding risk.

A complete list of contraindications is outside the scope of this review but is available elsewhere.33 Several studies in acute PE have evaluated the efficacy and safety of alteplase administered as a bolus (2 min) or accelerated infusion (10-15 min) [Table 3]. Levine et al. compared a weight based bolus dose of alteplase to placebo in 58 patients with an acute symptomatic PE.34 The primary outcome, greater than 50% improvement in perfusion at 24 hours, occurred more frequently in treated patients compared with placebo (34 vs 12%; p = 0.026). Safety endpoints of major bleeding and death were similar between groups. Although the findings suggest a bolus dose is effective and well tolerated the exclusion of patients with massive PE for ethical reasons (placebo controlled study) limits application of the findings to critically ill patients.

A pair of studies organized jointly by groups in the United States and Europe used similar trial protocols and provide the only comparison of the FDA approved regimen to an accelerated infusion.

Neither study detected a difference in efficacy or safety.35,36 The results from a pooled analysis demonstrated a nonsignificant trend toward reduction in major bleeding with the possibility of reduced efficacy and higher mortality when alteplase was administered at a lower dose over 15 min.37 A much larger (n=300 and n=800) study would be needed to confirm a reduction in bleeding and an increase in mortality, respectively.

Application of the findings to patients with massive PE is again difficult as the

Spring 2014 • Arizona Journal of Pharmacy • 33

P

Continuing Education (continued from page 33) trials primarily included patients who were hemodynamically stable.

The only data available from patients with massive PE originate from a prospective open label study.38 Unfortunately, the trial used an anatomical definition of massive and only 15 of 54 patients actually presented with shock. All patients received alteplase as a 10-minute infusion. Hemodynamic improvement within 2 hours was noted in 11 of the 15 patients with hypotension. Compared with other studies there was a greater incidence of death (9%) and intracranial bleeding (3.7%). Without a control group it is unclear if these differences are due to the use of an accelerated infusion or the inclusion of patients with shock and the elderly (mean age 70).

Data regarding the use of alteplase during cardiopulmonary resuscitation (CPR) are scarce, yet case reports suggest there may be a role for this treatment.39 Two studies using alteplase during cardiac arrest are notable. The first study compared patients before and after adopting protocol directed administration of intravenous alteplase (50 mg) and heparin (5,000 units) if return of spontaneous circulation (ROSC) was not achieved after 15 minutes.40 The control group consisted of 50 patients receiving standard advanced cardiac life support (ACLS) care. The majority (65%) of patients suffered a witnessed out of hospital arrest. Treated patients were more likely to achieve ROSC (68 vs 44%; p = 0.02) and survive to hospital discharge (15 vs 8%; p = NR) although the latter did not reach statistical significance. The second study randomized 233 patients with pulseless electrical activity (PEA) for greater than three minutes to alteplase (100 mg over 10 min) or placebo.41 No differences occurred in ROSC (21 vs 23%; p = 0.85) or survival to hospital discharge (1 vs 0%; p = 0.99). The very low rate of overall survival is expected with PEA arrest but may have undermined the ability to detect a treatment effect. Importantly, neither study reported any bleeding complications associated with alteplase administration during cardiopulmonary resuscitation (CPR). Alteplase should not routinely be given to patients with cardiac arrest but is not contraindicated during CPR. Although a variety of doses and rates have been evaluated in acute PE, most eligible patients should receive the FDA

Table 3. Alteplase Dosing in Investigative Studies34,35,36,38,40,41 Dose (IV) Minimum / Maximum Administration Time 100 mg* NA 2 hours 100 mg41 NA 15 min 1 mg/kg38 50 mg / 100 mg 10 min 0.6 mg/kg35,36 None / 50mg 15 min 0.6 mg/kg34 Using ideal weight 2 min 50 mg40† NA 2 min * FDA approved dosing † In conjunction with heparin 5,000 units IV

approved alteplase regimen. The use of an accelerated or bolus infusion should be considered in cases of actual or imminent cardiac arrest.31 An alteplase dose of 0.6 mg/kg (max 50 mg) administered over 15 minutes was shown to be non-inferior to the FDA approved dose in two randomized trials. No data are published comparing different bolus or accelerated infusions.

Given the absence of clear evidence for any specific regimen, the decision must be individualized to the specific clinical situation. Fixed dose regimens are attractive when a weight is unavailable or when expedited drug preparation using the available 50 and 100 mg vial sizes is necessary. In cases of cardiac arrest, bolus dosing can eliminate the need for an infusion set and pump. In these cases concurrent heparin could be considered in anticoagulation-naive patients.

Conclusion: Sharing of clinical pearls such as “From A to Z” via live educational sessions or written programs is a succinct method to disseminate several ideas, concepts, or facts for quick application in day-to-day patient-care.

References: Introduction to Clinical Pearls 1. Canaday B. ASHP’s Clinical Pearls. Bethesda, MD: American Society of Health-System Pharmacists; 2009.

Rare Diseases Electronic Resources 2. National Institutes of Health Office of Rare Diseases Research. Office of Rare Diseases Research (ORDR) Brochure. ORDR. www.rarediseases.info. nih.gov/asp/resources/ord_brochure.html (accessed 2014 Jan 1).

3. National Organization for Rare Disorders (NORD). Rare Disease Information. NORD. www. rarediseases.org/rare-disease-information (accessed 2014 Jan 1).

4. National Organization for Rare Disorders (NORD). Off-Label Pharmaceutical Use. www. rarediseases.org/advocacy/initiatives-updates/offlabel-use (accessed 2014 Jan 1).

5. National Organization for Rare Disorders (NORD). Rare Disease Database. NORD. www. rarediseases.org/rare-disease-information/rarediseases (accessed 2013 Feb 6).

34 • Arizona Journal of Pharmacy • Spring 2014

6. Anderson KE, Bloomer JR, Bonkovsky HL et al.

Recommendations for the diagnosis and treatment of the acute porphyrias. Ann Intern Med. 2005; 142:439-50.

7. Byrne PC. Training medical students on rare disorders. Orphanet J Rare Dis. 2012; 7:A15.

Abstract.

8. Burnworth MJ. Development of an elective course in rare and interesting diseases.

Currents in Pharmacy Teaching and Learning.

2013;5(6):564-573.

9. Burnworth MJ. Rare disease resources not as rare as one might think. Am J Health Syst Pharm.

2013;70:1013-14.

10. Canadian Organization for Rare Disorders (CORD) www.raredisorders.ca (accessed 2014 Jan 1).

11. Rare Diseases Europe (EURORDIS) www. eurordis.org (accessed 2014 Jan 1).

12. Genetic and Rare Diseases Information Center (GARD) www.rarediseases.info.nih.gov/GARD (accessed 2014 Jan 1).

13. National Organization of Rare Disorders (NORD) www.rarediseases.org (accessed 2014 Jan 1).

14. Canadian Organization for Rare Disorders (CORD) Newsletter. CORD. www.raredisorders.ca/ documents/CORDWinter2013Newsletter_000.pdf (accessed 2014 Jan 1).

15. Connecting Rare Disease Patients Globally.

Rare Connect. www.rareconnect.org (accessed 2014 Jan 1).

16. Ringler J. Abbey Meyers: The “Mother” of Invention. Pharmaceutical Executive. www. pharmexec.com/pharmexec/Abbey-Meyers-TheMother-of-Invention/ArticleStandard/Article/ detail/744329 (accessed 2014 Jan 1).

Medications in Nuclear Exposure 17. Arizona Division of Emergency Management.

Palo Verde Nuclear Generating Station. www.dem. azdema.gov/preparedness/paloverde/paloverde.html (accessed 2013 4 June).

18. Centers for Disease Control and Prevention: Office of Public Health Preparedness and Response.

Strategic National Stockpile (SNS). www.cdc.gov/ phpr/stockpile/stockpile.htm (accessed 2013 4 June).

19. The medical aspects of radiation incidents. The Radiation Emergency Assistance Center/Training Site. www.orise.orau.gov/reacts (accessed 2013 4 June).

20. Cesium. Environmental Protection Agency. www.epa.gov/radiation/radionuclides/cesium.html (accessed 2013 4 June).

21. Ferric Hexacyanoferrate. Lexi-Comp OnlineTM , Lexi-Drugs OnlineTM , Hudson, Ohio: Lexi-Comp, Inc. (accessed 2013 4 June).

22. Plutonium. Environmental Protection Agency. www.epa.gov/radiation/radionuclides/plutonium.html (accessed 2013 4 June).

23. Diethylene triamine penta-acetic acid. LexiComp OnlineTM , Lexi-Drugs OnlineTM , Hudson,

Continuing Education (continued from page 34) Ohio: Lexi-Comp, Inc. (accessed 2013 4 June).

24. Questions and Answers on CalciumDTPA and Zinc-DTPA. FDA bioterrorism and drug preparedness. www.fda. gov/Drugs/EmergencyPreparedness/ BioterrorismandDrugPreparedness/ucm130314.htm (accessed 2013 4 June).

25. Iodine. Environmental Protection Agency.

Available at www.epa.gov/radiation/radionuclides/ iodine.html#exposure (accessed 2013 4 June).

26. Frequently Asked Questions on Potassium Iodide (KI). FDA bioterrorism and drug preparedness. www.fda.gov/Drugs/EmergencyPreparedness/ BioterrorismandDrugPreparedness/ucm072265.htm (accessed 2013 4 June).

27. Potassium iodide. Lexi-Comp OnlineTM , LexiDrugs OnlineTM , Hudson, Ohio: Lexi-Comp, Inc. (accessed 2013 4 June).

28. PL Detail-Document, Potassium iodide (KI): frequently asked questions. Pharmacist’s Letter/ Prescriber’s Letter. March 2011.

29. Radiation Emergency Medical Management. US Department of Health and Human Services. www. remm.nlm.gov/ (accessed 2013 4 June).

Thrombolytic Administration in Massive Pulmonary Embolism 30. Goldhaber SZ, Visani L, De Rosa M. Acute pulmonary embolism: clinical outcomes in the International Cooperative Pulmonary Embolism Registry (ICOPER). Lancet. 1999;353(9162):1386.

31. Kearon C, Akl E, Comerota AJ et al.

Antithrombotic therapy for VTE disease.

Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012;142(6):1698-1704.

32. Stein PD, Matta F. Thrombolytic therapy in unstable patients with acute pulmonary embolism: saves lives but underused. Am J Med. 2012;125(5):465-70.

33. Torbicki A, Perrier A, Konstantinides S et al. Guidelines on the diagnosis and management of acute pulmonary embolism. European Heart Journal. 2008;29:2276–2315.

34. Levine MN, Hirsh J, Weitz J et al. A randomized trial of a single bolus dosage regimen of recombinant tissue plasminogen activator in patients with acute pulmonary embolism. Chest. 1990;98:1473-9.

35. Sors H, Pacouret G, Azarian R et al.

Hemodynamic effects of bolus vs 2-h infusion of alteplase in acute massive pulmonary embolism. A randomized controlled multicenter trial. Chest.

1994;106(3):712-7.

36. Goldhaber SZ, Agnelli G, Levine MN. Reduced Dose Bolus Alteplase vs Conventional Alteplase Infusion for Pulmonary Embolism Thrombolysis: An International Multicenter Randomized Trial. Chest.

1994;106(3):718-24.

37. Goldhaber SZ, Feldstein ML, Sors H. Two Trials of Reduced Bolus Alteplase in the Treatment of Pulmonary Embolism. Chest. 1994;106(3):725-6.

38. Diehl JL, Meyer G, Igual J et al. Effectiveness and safety of bolus administration of alteplase in massive pulmonary embolism. Am J Cardiol.

1992;70:1477-80.

39. Bailén, MR, Cuadra JAR, de Hoyos EA. Thrombolysis during cardiopulmonary resuscitation in fulminant pulmonary embolism: A review. Crit Care Med. 2001;29(11):2211-9.

40. Böttiger BW, Bode C, Kern S et al.

Efficacy and safety of thrombolytic therapy after initially unsuccessful cardiopulmonary resuscitation: a prospective clinical trial. Lancet.

2001;357(9268):1583-5 41. Abu-Laban RB, Christenson JM, Innes GD et al. Tissue plasminogen activator in cardiac arrest with pulseless electrical activity. N Engl J Med. 2002;346(20):1522-8.

There are neither financial nor material supports nor conflicts of interest to disclose for the authors.

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Arizona Center for Professional Education

National Drug Take Back Event April 26, 2014 10 am to 2 pm For take-back locations, visit the DEA website at: http://www.deadiversion.usdoj.gov/drug_disposal/takeback/index.html

Arizona Center for Professional Education

brought to you by the Arizona Pharmacy Association Your online source for continuing pharmacy education, skills enhancement, and professional development.

Visit www.azpharmacy.org Spring 2014 • Arizona Journal of Pharmacy • 35

Continuing Education

Bipolar Disorder: A Pharmacotherapy Management Overview

by Huong Le, Pharm.D. Candidate 2014, Julie Nguyen, Pharm.D. Candidate 2014, Tina Pham, Pharm.D. Candidate 2014, Laura Tsu, Pharm.D., BCPS, Midwestern University College of Pharmacy â&#x20AC;&#x201C; Glendale Goals This home-study CPE activity has been developed to educate pharmacists on bipolar disorder and its management using non-pharmacologic and pharmacologic therapies.

Objectives 1. Distinguish between Bipolar Disorder I and Bipolar Disorder II and the different mood disorders 2. Compare the differences between a manic and a depressive state 3. Develop a therapeutic plan for a newly diagnosed bipolar patient 4. Compare different pharmacologic agents in terms of efficacy, adverse effects, and monitoring 5. Design treatment recommendations for special population groups Introduction Bipolar disorder is a common and debilitating mood disorder, with an estimated lifetime prevalence of bipolar I disorder and bipolar II disorder of 1% and 1.1%, respectively, in the United States.1 The mean age of onset for bipolar I disorder and bipolar II disorder is 18 and 20 years, respectively, with equal gender prevalence occurring in bipolar I disorder and a higher prevalence in women for bipolar II disorder.1 The pathophysiology of bipolar disorder is unknown, but the etiology is thought to involve biological, psychological, and social factors. There is a complex genetic component with 80-90% of patients with bipolar disorder having a relative with a mood disorder.

The brain structure and function in these patients are also altered, but it is unclear if these changes occurred before or after clinical presentation of the disorder.1 Environmental influences such as stressful life events, alcohol or substance abuse, and changes in sleep-wake cycle may also affect the course of the disorder by dysregulating neurotransmitters, hormones, endocrine function, neuropeptides, cations, intracellular messengers, and signal transduction pathways. Appropriately diagnosing bipolar disorder is crucial, because there are other psychiatric and neurologic disorders that may present similarly with manic-like or depressive-like symptoms.1

For example, if an individual with bipolar disorder was misdiagnosed to have attention-deficit/hyperactivity disorder (ADHD), the central nervous system stimulant prescribed can actually worsen symptoms of mania or depression and decrease response to treatment. There are three types of bipolar disorder. Bipolar I Disorder primarily presents with manic, or rapid cycling episodes of mania and depression. Bipolar II Disorder primarily presents with recurrent depression accompanied by hypomanic episodes.

Cyclothymic Disorder is a chronic state of cycling between hypomanic and dysthymic episodes that do not reach the diagnostic criteria for bipolar disorder.1 Diagnosis Major Depressive Depressed mood and/or loss of interest or pleasure for at least 2 weeks and at least 5 of the following:2 1. Depressed mood 2. Decreased interest or pleasure in normal activities 3. Unintentional weight loss or gain 4. Insomnia or hypersomnia 5. Agitation or psychomotor retardation 6. Fatigue or decreased energy 7. Feelings of worthlessness or guilt 8. Decreased ability to concentrate or make decisions 9. Suicidal thoughts Dysthymic Disorder Depressed mood for more days than not for at least 2 years and at least 2 of the following:2 1. Loss of appetite or overeating 2. Insomnia or hypersomnia 3. Fatigue or decreased energy 4. Low self-esteem 5. Decreased ability to concentrate or make decisions 6. Feelings of hopelessness Manic Abnormal and persistent elevated mood for at least 1 week and at least 3 of the following:2 1. Inflated self-esteem or grandiosity 2. Decreased need for sleep 3. Increased talking 4. Flight of ideas or racing thoughts 5. Distractible

36 â&#x20AC;˘ Arizona Journal of Pharmacy â&#x20AC;˘ Spring 2014

6. Increased activity (socially, at work, or sexually) 7. Increased psychomotor agitation 8. Excessive involvement in pleasurable activities that have high risk for serious consequences Hypomanic Abnormal and persistent elevated mood for at least 4 days and at least 3 of the following:2 1. Inflated self-esteem or grandiosity 2. Decreased need for sleep 3. Increased talking 4. Increased activity (socially, at work, or sexually) 5. Increased psychomotor agitation 6. Excessive involvement in pleasurable activities that have high risk for serious consequences Mixed Criteria for both major depressive and manic episodes that occur almost every day for at least a 1 week period.2 Rapid cycling More than 4 major depressive or manic episodes (manic, hypomanic, or mixed) in 12 months.2 Non-Pharmacological Treatments The goals of treatment for bipolar disorders aim to achieve remission, which is defined as complete return to normal functioning and lack of symptoms, to prevent relapses, to control comorbid conditions including anxiety, panic disorder, obsessive-compulsive disorder (OCD), and ADHD. Three non-pharmacological approaches to the treatment of bipolar disorders encompass health maintenance, mood charting, and a combination of pharmacotherapy plus psychoeducation.3 Maintaining health through adequate sleep, nutrition, and exercise can improve and prevent signs and symptoms of bipolar episodes.

Benzodiazepines, melatonin, enforced darkness, and prolonged bed rest have been shown to help patients sleep. Sleep hygiene is also crucial in obtaining adequate sleep. This includes counseling patients to establish a fixed sleep and wake time, to exercise but not close to bedtime, and to avoid naps. In addition

Continuing Education (continued from page 36) to getting adequate sleep, nutrition plays an important role in managing bipolar disorders. Patients should be counseled to maintain an adequate intake of essential amino acids, fatty acids, vitamins, and minerals based on the Reference Daily Intake (RDI).3 Exercise, either strength training or aerobic, can help with sleep and major depressive disorder (MDD) by increasing the synthesis and release of neurotransmitters such as serotonin and norepinephrine.4 Mood charting is another approach to manage bipolar disorders by assisting patients in detecting signs and symptoms of episodes and assessing their responsiveness and tolerability to the drug regimen. Finally, a combination of pharmacotherapy and psychoeducation can enhance the treatments and prevent relapses of bipolar episodes. Cognitive behavior therapy, reducing psychosocial stressors, mental health organizations, and other support groups, including individual or family therapy, are recommended as adjunct therapies to pharmacologic agents.

Other non-pharmacologic approaches have been shown to be effective in treating patients who have failed pharmacologic agents. These approaches include electroconvulsive therapy (ECT), transcranial magnetic stimulation, and vagus nerve stimulation.

Pharmacological Treatments Manic Phase (Acute Manic, Hypomanic, Mixed) The manic phase can be acute manic, hypomanic, or mixed. The treatment plans in the manic phase include remission, assessment of the causes and triggers such as alcohol, drug, or substance abuse. Other contributory factors can be stimulants, caffeine, or antidepressant monotherapy. For severe cases of mania, first line treatments are combinations of lithium plus antipsychotics or valproate plus antipsychotics.5,6 For less severe cases, lithium, valproate, or antipsychotic monotherapy is sufficient. Alternatives to lithium or valproate can be carbamazepine or oxcarbazepine. Adjunctive therapy with psychosocial approaches can also be beneficial. For mixed or rapid cycling, valproate is preferred over lithium.

Whenever psychosis is manifested in the manic phase, antipsychotics need to be considered.5,6 Second generation antipsychotics (SGAs), also known as atypical antipsychotics are preferred over first generation antipsychotics

(FGAs), also known as typical antipsychotics. SGAs have lower risk of extrapyramidal side effects such as tardive dyskinesia, dystonia, and Parkinson’s like symptoms and have less effects on prolactin.5,6 Examples of SGAs are olanzapine, ziprasidone, risperidone, and quetiapine. Examples of FGAs are chlorpromazine, fluphenazine, and haloperidol. For breakthrough manic or mixed episodes, the dose should be optimized to the therapeutic range, add or continue antipsychotics, or consider adding a short-term benzodiazepine. If patients are refractory to the first line treatments, the recommendations are to add another first line agent, carbamazepine or oxcarbazepine, add or switch an antipsychotic, or utilize ECT.5,6 Depressive Phase The treatment plans for the depressive phase aim to achieve remission, avoid antidepressant monotherapy due to precipitation of mania or hypomania, assess causes or triggers of depression such as alcohol, drug or substance abuse, and to taper off antipsychotics, benzodiazepines, and sedative-hypnotics.

First line agents for bipolar depression are lithium or lamotrigine. Alternative agents are quetiapine monotherapy or olanzapine plus fluoxetine, valproate, lithium plus antidepressant, or adjunctive psychotherapy.5,6 In July 2013, lurasidone was approved as monotherapy or adjunctive therapy in the treatment of bipolar depression. For breakthrough bipolar depression, optimize dose of the maintenance drug until it is within therapeutic range.7 For patients who are refractory to first line treatments, add lamotrigine, bupropion, paroxetine or alternatively add other antidepressants or monoamine oxidase inhibitors (MAOIs).

ECT is recommended for severe, refractory depression with psychosis or catatonia.5,6 Rapid Cycling The treatment plans for rapid cycling are to reduce the numbers of episode and assess issues that can contribute to cycling, including hypothyroidism, drug or substance abuse, or alcoholism. First line agents include lithium or valproate, and an alternative would be lamotrigine. Rapidcycling patients will eventually require combination therapy.5,6

Maintenance Treatments Following an episode, all patients are required to be on maintenance or continuation of therapy for up to six months due to the high risk of relapse. The selection of medications for maintenance agents is the agent that induces remission. Furthermore, psychosocial therapies such as evaluating adherence, support groups, lifestyle, and mood charting are also considered.

First line agents for maintenance are lithium or valproate with lamotrigine, carbamazepine, or oxcarbazepine as alternatives. Antipsychotics should be evaluated for risks versus benefits before considering them for long-term use. In bipolar I, the duration of maintenance after one manic episode is 12 months, and lifelong for more than one episode. In bipolar II, the duration of maintenance after one to two hypomanic phases is 12 months, and lifelong if more than two episodes.5,6 Drug Therapies Lithium (Eskalith®, Lithobid®) Lithium works by affecting the reuptake of serotonin and norepinephrine. In doing so, lithium can be used for the depressive stage of bipolar. However, lithium has a stronger effect on managing mania by suppressing excitatory neurotransmission (e.g. dopamine and glutamate) while increasing inhibitory activity (GABA).7 Studies have shown that lithium has similar efficacy to valproate, carbamazepine, risperidone, olanzapine, chlorpromazine and other first generation antipsychotics. Its efficacy is enhanced in patients who have fewer prior episodes, family history of responsiveness to lithium, and euthymia between episodes. In mixed or rapid-cycling, the efficacy of lithium is reduced. Lithium is used as a first line agent for mania, hypomania, depression, and maintenance.

Combination therapy with carbamazepine, valproate, and antipsychotics can be seen.

Adverse effects are seen in multiple organs and can be dose dependent.

Central nervous system (CNS) effects of headache, memory and cognitive impairments, coma, confusion, seizure, sedation, lethargy and stupor are dose related. Other dose related side effects include nausea, vomiting, diarrhea, dyspepsia, weight gain, hair loss, worsening of rash or psoriasis, and tremor. Lithium can decrease response

Spring 2014 • Arizona Journal of Pharmacy • 37

Continuing Education (continued from page 37) to antidiuretic hormones (ADH), causing polyuria, polydipsia, and nocturia. Other dose related effects on the kidneys include albuminuria and glycosuria. Lithium can accumulate in the thyroid gland and interfere with synthesis of thyroid hormones, thus causing hypothyroidism.

Lithium can also cause cardiac problems such as atrioventricular (AV) block, arrhythmias, hypotension, syncope and ECG changes. Thus, patients with a history of cardiac abnormalities need to have their ECG monitored at baseline and during treatment. Lithium can further lead to leukocytosis and blurred vision. Unlike other pharmacologic treatments for bipolar disorder, the long term use of lithium can reduce risk of suicidal ideation.

Drugs that can increase lithium concentration include ACE inhibitors, NSAIDs, and thiazides while theophylline, caffeine, and loop diuretics can decrease lithium concentration. Dehydration, vomiting, or diarrhea can also raise lithium levels. At the initiation of therapy, serum levels are drawn twice weekly until the level is stabilized. Once stabilized, it is then recommended to draw levels every 2 months. Serum concentrations for acute episodes are 1 – 1.2 mEq/L and 0.6 – 1.2 mEq/L for maintenance.

Furthermore, electrolytes, thyroid function tests, hematologic and dermatologic tests should be monitored at baseline and every 6-12 months, with the exception of dermatologic test, which should be done every 3-6 months.

Monitoring serum levels of lithium is important to avoid toxicity, which can be seen when the serum level is greater than 1.5 mEq/L, with signs and symptoms of tremor, nausea, diarrhea, blurred vision, vertigo, and confusion. When the level is greater than 2.5 mEq/L, toxicity is manifested in seizures, dysrryhthmias, and coma. Treatments for lithium toxicity include gastric lavage, induction of emesis, and hemodialysis when serum concentration is above 2.5 mEq/L. For dosing information, refer to Table 1.8,9

mood in mania. Studies have shown that valproate has better efficacy than lithium in patients with mixed episodes, many prior mood episodes, and rapid cycling.

Similar efficacy is seen with olanzapine and haloperidol. Valproate is used as first line therapy for acute mania, hypomania, mixed, and maintenance. It can also be combined with lithium, carbamazepine, and antipsychotics. After two weeks of initiating therapy, trough levels of acute manic or mixed episodes should be at 50 – 125 mcg/mL. Adverse effects of valproate target multiple organs and can be dose dependent. The most common adverse effects are dose-related nausea, vomiting, diarrhea, abdominal pain, dyspepsia, and flatulence. Valproate can also cause CNS issues, including headache, somnolence, dizziness, nervousness, and sedation.

Caution must be taken in patients with liver disease because valproate can increase liver function test (LFTs) and precipitate hepatic failure. Valproate can further cause tremor, weakness, diplopia, and blurred vision. Rare but serious side effects are hepatic failure, pancreatitis, and agranulocytosis. Valproate is contraindicated in pregnancy, with a black box warning for teratogenicity, pregnancy category X. When combined with lamotrigine, valproate will inhibit lamotrigine’s metabolism and dosing adjustment is therefore required. Valproate is highly protein bound and will displace other drugs readily. Finally, it will inhibit CYP 450 isoenzymes 3A4, 2C9, and 2D6. Hematologic, hepatic, dermatologic and metabolic tests should be monitored at baseline, then every 3-6 months.

Serum levels should also be monitored for toxicity, where sign and symptoms include somnolence, heart block, and coma. Treatment of toxicity would be hemodialysis. Behavior changes and suicide ideation should also be assessed periodically. For dosing information, refer to Table 1.8,9

Valproate (Depakote®) Formulations of valproate consists of valproate sodium, valproic acid, and divalproex sodium. Valporate increases the availability of gamma-aminobutyric acid (GABA) and enhances or mimics the action of GABA. By increasing GABA activity, valproates can manage the abnormal, persistent, and elevated

Carbamazepine (Tegretol®) The mechanism of action of carbamazepine is to decrease synaptic transmission, decrease activity in the thalamus, and decrease the transport of sodium across cell membranes, and potentiating GABA receptors.

By decreasing synaptic transmission via blockage of sodium across cell

38 • Arizona Journal of Pharmacy • Spring 2014

membranes, cells are less excitable and an abnormally elevated mood can be better managed. Studies show that the efficacy of carbamazepine is similar to lithium, but less than valproate. Carbamazepine is used as an alternative treatment and be combined with lithium, valproate, or antipsychotics. There is no established goal serum level for carbamazepine in the treatment of bipolar disorder. However, the target serum level of 4 – 12 mcg/ mL for seizures is often used for bipolar disorder.

The adverse effects of carbamazepine include multiple organs, with the most common side effects being CNS related: dizziness, drowsiness, headache, ataxia, cognitive and memory impairments, and rare cases of neuroleptic malignant syndrome (NMS). Cardiac issues caused by carbamazepine include hypertension or hypotension, syncope, AV block, arrhythmias, and edema. Gastrointestinal side effects are nausea, vomiting, diarrhea, dry mouth/throat, and anorexia.

Impotence and polyuria can occur along with increase in LFTs. Hematologic side effects are agranulocytosis, anemia, and thrombocytopenia. Carbamazepine can induce symptoms of inappropriate ADH (SIADH), abnormal thyroid function test, hypocalcemia, and hyponatremia.

Certain populations, such as Asian, Native American, Latin American, AfricanAmerican, and Indian are at greater risks of developing Stevens-Johnson syndrome (SJS) due to the presence of the HLA-B*1502 allele.

In addition to being a CYP 3A4 inhibitor, carbamazepine also has a unique mechanism of being able to autoinduce its own metabolism. Thus, it is important to adjust the dose based on patient’s liver function. Since carbamazepine can decrease the concentration of oral contraceptives (OC), back up methods or an increase in OC dose should be considered. When combined with clozapine, there is an increased risk of bone marrow suppression. And when added to valproate, the concentration of carbamazepine will increase. Monitor serum level for toxicity, which can be manifested in dizziness, sedation, visual changes, respiratory dysfunction, and arrhythmias. Treatments of toxicity include relieving symptoms, gastric lavage, or hemoperfusion. For dosing information, refer to Table 1.8,9

Oxcarbazepine (Trileptal®) The mechanism of action of oxcarbazepine is to decrease synaptic transmission by blocking sodium voltagegated channels, similar to carbamazepine.

Studies have shown that oxcarbazepine has similar efficacy to lithium and haloperidol; however, these studies lack power. Oxcarbazepine is used as an alternative treatment for bipolar either as monotherapy or in combination with other agents, after patients have failed carbamazepine, lithium, and valproate.

The advantages of oxcarbazepine over carbamazepine include having fewer adverse effects, fewer drug interactions, and no autoinduction. However, oxcarbazepine causes greater risk of hyponatremia, which can cause nausea, vomiting, confusion, and seizures.

The most common adverse effects are CNS related, including dizziness, drowsiness, headache, ataxia, vertigo, fatigue, sedation. Other side effects are nausea, vomiting, abdominal pain, along with abnormal gait and tremor, diplopia and nystagmus. Cross-sensitivity to oxcarbazepine is seen in approximately 25% -30% of patients who are allergic to carbamazepine. Hypersensitivity reactions include angioedema and SJS. Oxcarbazepine is a CYP 3A4 inducer and CYP 2C19 inhibitor and will decrease concentrations of oral contraceptives and dihydropyridine calcium channel blockers.

It is recommended to monitor serum levels of sodium for signs and symptoms of hyponatremia while patients are on oxcarbazepine. For dosing information, refer to Table 1.8,9 Lamotrigine (Lamictal®) Lamotrigine, a mood stabilizer, is commonly used as a first-line treatment for patients with bipolar II disorder.

There is a black box warning for serious skin rashes, which may lead to the SJS. The concomitant use with valproate can increase this risk of rash.

Signs of rashes should be monitored at baseline and every 3-6 months.

Common adverse effects include nausea, vomiting, insomnia, ataxia, dizziness, and headache. Carbamazepine increases the metabolism of lamotrigine which may result in subtherapeutic levels of lamotrigine. There are also drug-drug interactions with oral contraceptives.

The estrogen component can decrease the effectiveness of lamotrigine, while

Continuing Education (continued from page 38) lamotrigine can decrease the effectiveness benzodiazepines. Benzodiazepines may of oral progestin contraceptives. Doses also increase the serum level of selective should be decreased in renal and hepatic serotonin reuptake inhibitors (SSRIs), impairment. LFTs and serum creatinine which increases the risk of psychomotor (SCr) should be monitored regularly impairments. For dosing information, during therapy. Anticonvulsants increase refer to Table 1.8,9 the risk of suicidal thoughts and behaviors, so patients should be monitored for Selective Serotonin Reuptake Inhibitors emergence or worsening of depression or Examples of SSRIs are citalopram suicidal ideation. For dosing information, (Celexa®), escitalopram (Lexapro®), refer to Table 1.8,9 fluoxetine (Prozac®), paroxetine (Paxil®), and sertraline (Zoloft®). SSRIs are ® Quetiapine (Seroquel ) generally used as first line antidepressants Quetiapine, an atypical antipsychotic, because of their safety in overdose is used for the acute treatment of and improved tolerability. Common manic episodes associated with bipolar adverse effects include nausea, vomiting, disorder, acute treatment of depressive diarrhea, headache, insomnia, and sexual episodes associated with bipolar I and dysfunction. Citalopram can also cause II, and maintenance treatment of bipolar dose-related QT prolongation and doses I disorder. Common adverse effects should not exceed 40 mg/day for all include increase in diastolic and systolic patients and should not exceed 20 mg/day blood pressure in children, somnolence, for patients over 60 years old, have hepatic headache, agitation, dizziness, metabolic impairment, or are concurrently taking effects, dry mouth, weight gain, and a CYP 2C19 Inhibitor (e.g. omeprazole, increased appetite. Concomitant use with cimetidine). Abrupt withdrawal can cause acetylcholinesterase inhibitors should flu-like symptoms, light-headedness or be avoided since severe extrapyramidal dizziness, uneasiness, sleep disturbances, and headache. Therefore, SSRIs should symptoms may be precipitated. CYP3A4 inducers (e.g. progesterone, phenytoin, be tapered down when discontinuing oxcarbazepine, carbamazepine, and treatment with the exception of fluoxetine phenobarbital) may decrease the due to its long half-life. SSRIs are highly serum level of quetiapine. To maintain bound to plasma protein and co-admission with other highly protein-bound drugs therapeutic benefit, quetiapine doses may be increased to up to 5 times when used (e.g. valproate, warfarin, digoxin) may with CYP3A4 inducers. Fasting lipid cause changes in serum concentrations profile (FLPs) should be monitored due of either drugs. SSRIs have varying to metabolic increases in triglyceride and degrees of CYP 2D6 inhibition and decreased HDL levels. Weight, blood may affect drugs that are metabolized pressure, worsening of depression or by this isoenzyme (e.g. phenothiazine suicidal ideation should be monitored antipsychotics, risperidone). Fluoxetine regularly. For dosing information, refer to and paroxetine are strong CYP 2D6 Table 1.8,9 inhibitors while sertraline is a moderate CYP 2D6 inhibitor, and citalopram Benzodiazepines and escitalopram are weak CYP 2D6 The most commonly studied and used inhibitors. Citalopram and escitalopram benzodiazepines in bipolar disorder are are metabolized by CYP 3A4 and CYP lorazepam (Ativan®) and clonazepam 2C19, and concomitant use with a CYP (Klonopin®), which has beneficial effects 3A4 inducer (e.g. carbamazepine) may in the treatment of hypomanic, mild to decrease their serum levels. Use of a moderate manic, and mixed episodes.5 SSRI with a MAOI is contraindicated Benzodiazepines are generally used as due to the increased risk of hypertensive adjunctive therapy for treating insomnia, crisis, serotonin syndrome, and delirium. agitation, and anxiety in bipolar patients There is a Black Box Warning of increased with elevated moods. Common adverse suicidal ideation with antidepressant use effects include sedation, respiratory and suicidal thoughts should be assessed depression, hypotension, and changes in and monitored regularly. For dosing appetite, and therefore respiratory and information, refer to Table 1.8,9 cardiovascular status should be closely monitored. Concomitant use with Bupropion (Wellbutrin®) olanzapine may increase the toxicity of Bupropion works as an antidepressant Spring 2014 • Arizona Journal of Pharmacy • 39

Continuing Education (continued from page 39) by inhibiting norepinephrine and dopamine reuptake. Common adverse effects include nausea, vomiting, dry mouth, skin reactions, insomnia, and seizures. Bupropion is metabolized

by CYP 2B6 and has few drug-drug interactions. However, concomitant use with carbamazepine may lower bupropion levels and dose adjustments may be required. Contraindications with bupropion include concomitant use with a MAOI, seizure disorder, and history of an eating disorder. There is a Black Box Warning of increased suicidal ideation with antidepressant use and suicidal thoughts should be assessed and monitored regularly. For dosing information, refer to Table 1.8,9

antidepressants. Overdose can occur and symptoms may include irritability, hyperactivity, anxiety, tachycardia, drowsiness, and hallucinations. There are many drug-drug interactions and contraindications to MAOIs include concomitant use with other antidepressants, pheochromocytoma, congestive heart failure, hepatic impairment, renal impairment, cerebrovascular disorders, cardiovascular disease, hypertension, and history of headache. There is a Black Box Warning of increased suicidal ideation with antidepressant use and suicidal thoughts should be assessed and monitored regularly. For dosing information, refer to Table 1.8,9

Venlafaxine (Effexor®) Venlafaxine is a serotonin and norepinephrine reuptake inhibitor (SNRI) that is generally used as a second-line antidepressant. Common adverse effects include significant nausea, constipation, dry mouth, decreased appetite, headache, somnolence, dizziness, insomnia, dose-related increase in diastolic blood pressure, and sexual dysfunction. Blood pressure should be monitored regularly, and doses should be decreased in patients with renal and/or hepatic impairment.

Abrupt withdrawal with SNRIs may be worse than with SSRIs and symptoms may include agitation, confusion, excessive sweating, hallucinations, and hyperreflexia. There are minimal drugdrug interactions but concomitant use with a MAOI is contraindicated. There is a Black Box Warning of increased suicidal ideation with antidepressant use and suicidal thoughts should be assessed and monitored regularly. For dosing information, refer to Table 1.8,9

Olanzapine/ fluoxetine (Symbyax®) This combination agent contains olanzapine, a SGA that inhibits serotonin, dopamine, histamine, and alpha1-adrenergic reuptake, and the SSRI fluoxetine. Due to the synergistic increase in serotonin, norepinephrine, and dopamine, there is an enhanced antidepressant effect for this drug combination. Olanzapine/fluoxetine is commonly used for depressive episodes associated with bipolar I disorder and treatment-resistant depression, which is defined as being unresponsive to two trials of different antidepressants in the current episode. Common adverse reactions to this combination agent include somnolence, fatigue, hyperprolactinemia, weight gain, increased appetite, and dry mouth. There are many drug-drug interactions associated with olanzapine/ fluoxetine and concomitant use with other SSRIs, antipsychotics, and lithium may lead to serotonin syndrome/toxicity.

Concomitant use with a MAOI should be avoided. Doses should be decreased in hepatic impaired and hypotensive patients, and LFTs and blood pressure should be monitored regularly in these patients. For dosing information, refer to Table 1.8,9

Monoamine Oxidase Inhibitors MAOIs such as selegiline (Emsam®), phenelzine (Nardil®), and tranylcypromine (Parnate®) work by increasing concentrations of norepinephrine, serotonin, and dopamine. They are rarely used as a first line drug therapy and are indicated for patients with atypical depression or patients unresponsive to other antidepressants. Common adverse effects include orthostatic hypertension, sedation, stimulant, weight gain, and sexual dysfunction. Hypertensive crisis may occur when taken with food containing tyramine and other

Special Populations Women and Pregnancy Due to higher risks of birth malformations associated with medications used to treat bipolar disorder, all female patients of childbearing age are encouraged to practice effective contraceptive methods while on pharmacological therapy.5 Oral contraceptives should be avoided

40 • Arizona Journal of Pharmacy • Spring 2014

in patients taking carbamazepine, oxcarbazepine, and topiramate because these medications increase the metabolism of oral contraceptives, thus decreasing their effectiveness. Effective backup contraceptive practices, such as condoms or intrauterine devices, are recommended for birth control in these patients.

When a patient is pregnant, the risks and benefits of continuing versus discontinuing medications for bipolar disorder should be evaluated carefully. Should the decision be made to continue pharmacotherapy, clinicians and pharmacists should choose drugs with fewer known teratogenic effects and when possible, the lowest effective dose should be used. Congenital malformations have been documented with first-trimester exposure to lithium, valproate, and carbamazepine. A common neonatal complication associated with lithium use near labor is the “floppy baby” syndrome, which is characterized by cyanosis and hypotonicity. The use of carbamazepine and valproate sodium during the first trimester has been associated with neural tube defects.10 Benign risks have been documented with SSRIs use during pregnancy, with fluoxetine and citalopram having the strongest safety data. Similarly, past studies have demonstrated no association between lorazepam and clonazepam with birth defects. However, diazepam remains controversial due to earlier reports of increased risks of oral cleft malformations during the first trimester.10 Antipsychotic medications may be added to the bipolar regimen to treat psychotic features. Highpotency antipsychotic agents are preferred due to their decreased anticholinergic, antihistaminergic, and hypotensive effects.5 Use of high-potency agents near term, however, has demonstrated short-lived extrapyramidal side effects in neonates. Haloperidol is recommended as the first line therapy because it is not associated with congenital anomalies.5 Prenatal monitoring is recommended for all females who choose to remain on lithium, valproate, or carbamazepine during their pregnancy.12 At the 20th week of gestation, a maternal serum of α-fetoprotein screening for neural tube defects is recommended with amniocentesis. Ultrasound examination at 16-18 weeks gestation is also recommended to detect cardiac abnormalities. Close monitoring of the serum drug levels should be continued

Continuing Education (continued from page 40) throughout the pregnancy due to changes in hepatic metabolism, renal excretion, and fluid volumes.

It is crucial that the patients and their family members understand the importance of medication adherence for safety and efficacy purposes. For instance, patients may not be aware that abrupt discontinuation of an SSRI may lead to withdrawal syndromes or that non-adherence can worsen their mood episodes. It is especially essential to educate special patient populations, such as patients with pregnancy and lactation concerns due to the high teratogenic risk.

It is also important to educate the patients and their family members to identify behavioral changes and early signs of suicidal ideation as serious side effects of the medication. Overall, pharmacists can have a significant role in the management and well-being of their bipolar patients by helping them to monitor and provide education about their disease state.

3. Portugal E, Cevada T, Monteiro RS et al.

Neuroscience of exercise: from neurobiology mechanisms to mental neuroscience of exercise.

Neuropsychobiology 2013;68:1–14.

4. American Psychiatric Association. Practice guideline for the treatment of patients with bipolar disorder (revision). Am J Psychiatry 2002;159:1–50.

5. American Psychiatric Association. Practice guideline for the treatment of patients with bipolar disorder: second edition. Am J Psychiatry 2010;1–82.

6. Malhi GS, Tanious M, Coulston CM et al.

Potential mechanisms of action of lithium in bipolar disorder: Current understanding. CNS Drugs.

2013;274(2):135-53.

7. Lexicomp Online, Lexi-Drugs, Hudson, Ohio: Lexi-Comp, Inc.; 2014; September 21, 2013.

8. Drug Facts and Comparisons. Facts & Comparisons [database online]. St. Louis, MO: Wolters Kluwer Health, Inc; March 2005. Accessed Sept 27, 2014.

9. Yonkers KA, Wisner KL, Stowe Z et al.

Management of bipolar disorder during pregnancy and the postpartum period. Am J Psychiatry.

2004;161:608-620.

10. Sharma V. Management of bipolar II disorder during pregnancy and the postpartum period.

Canadian journal of clinical pharmacology.

2008;16(1):1198-581.

11. Viguera AC, Nonacs R, Cohen LS et al. Risk of recurrence of bipolar disorder in pregnant and nonpregnant women after discontinuing lithium maintenance. Am J Psychiatry 2000; 157:179–184.

Postpartum and Breast-feeding During the postpartum period, females are more likely to relapse into mania, depression, or psychosis. Women with previous postpartum episodes have the highest risk to have another affective episode after subsequent pregnancies.

Therefore, prophylactic medications such as lithium or valproate are recommended in women with bipolar disorder to prevent postpartum mood episodes.5 Pharmacists should also counsel women on the importance of maintaining a normal sleep pattern to avoid precipitating episodes of mania.

Although all medications used in the treatment of bipolar disorder are secreted in breast milk at different degrees, the References risks of breastfeeding must be weighed 1. Drayton SJ. Chapter 78. Bipolar Disorder. against the benefits in this patient In: DiPiro JT, Talbert RL, Yee GC, Matzke GR, population. Lithium is not recommended Wells BG, Posey L. eds. Pharmacotherapy: during lactation, because it is secreted A Pathophysiologic Approach, 8e. New York: McGraw-Hill; 2011.American Psychiatric in breast milk at 40% of maternal serum Association: Diagnostic and Statistical Manual of 5 concentration. Lamotrigine level Mental Disorders, Fourth Edition, Text Revision. is secreted at 25% of maternal level, Washington, DC: American Psychiatric Association, but no recommendations are made 2000:345–401.

2. Goldberg JF, Harrow M, et al. Bipolar Disorders: concerning its use in breastfeeding.5 Clinical Course and Outcome. Washington, DC: Other antipsychotics, antidepressants, and American Psychiatric Press 1999. benzodiazepines are found in measurable levels in breast milk and have the potential Table 1: Table Drug Dosing 1 to affect the infant’s central nervous system.

Drug

Pharmacist Role/Conclusion Bipolar disorder can be effectively managed with the help of pharmacists, physicians, and psychiatrists. As clinical pharmacists, obtaining an accurate and complete medication history is critical to identifying potential medication-related causes of mood episodes. Pharmacists can also help to assess the number of manic and depressive episodes throughout the course of therapy to optimize the patient’s medication therapy. Patient education is an important component to successful therapy management. By educating the patient about the disease state and the drug therapy, patients are empowered to take charge of their own health and are therefore more likely to maintain medication adherence. In addition, performing long-term monitoring as part of medication therapy management can increase patient adherence and reduce future hospitalizations.

Lithium

ACPE UAN#0100-0000-14-018-H01-P

Initial Dose (mg/day) 900 in 3-4 divided doses

Usual Dose (mg/day)

Valproate

750 in 3 divided doses

0.5-1.2 mEq/L (serum level) 60 mg/kg

Carbamazepine

400 in 2 divided doses

800-1000

Oxcarbazepine

600

1200

Lamotrigine

25-50

100-400

Olanzapine/Fluoxetine

6/25

6-12(O)/25-50(F)

Quetiapine

50

300-800

Citalopram

20

20-40

Escitalopram

10

10-20

Fluoxetine

20

20-60

Paroxetine

20

20-60

Sertraline

50

50-200

Buproprion

150

150-300

Venlafaxine

37.5-75

75-375

Selegiline

6

6-12

Phenelzine

45 in 3 divided doses

45-90

10

30-60

Tranylcypromine

Arizona Journal of Pharmacy • Spring 2014 • 41

Continuing Education Answer Sheet

I.

From A to Z: Clinical Pearls for the Acute Care Pharmacist. Part 1 ACPE UAN#0100-0000-14-017-H01-P

Activity accredited date: 04/01/2014 Expiration date: 04/01/2017. 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.

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.

b.

ACTIVITY EVALUATION – Must be completed to receive credit.

1. The activity met the stated learning objectives. (Full list of learning objectives in article.)

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

3. The information presented (check all that apply):

Reinforce my current practice/treatment habits Provided new ideas or information I expect to use

Questions on page 38. b. c. d. b. b. c. d. b. c. d. e.

AGREE

DISAGREE

Poor Poor Poor

2 2 2

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?

7.

Do you feel future activities on this subject matter are necessary and/or important?

No No

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1

2

3

Yes

4

5 Very committed

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Bipolar Disorder: A Pharmacotherapy Management Overview ACPE UAN#0100-0000-14-018-H01-P

accredited date: 04/01/2014 Expiration date:04/01/2017. This activity is accredited for 2.0 hours of CPE credit (CEUs 0.20) II. Activity 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.

7. a. b. c. d.

2. a. b. c. d.

8. a. b. c. d.

3. a. b. c. d.

9. a. b. c. d.

4. a. b. c. d.

10. a. b. c. d.

13.

14.

15.

16.

a. a. a. a.

b. b. b. b.

c. c. c. c.

d. d. d. d.

5.

6.

17.

18.

a. a.

b. b.

c. c.

d. d.

a. a.

b. b.

c. c.

d. d.

11.

12.

a. a.

b. b.

c. c.

d. d.

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1. The activity met the stated learning objectives. (Full list of learning objectives in article.)

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

3. The information presented (check all that apply):

Reinforce my current practice/treatment habits Provided new ideas or information I expect to use

AGREE

DISAGREE

Poor Poor Poor

2 2 2

1 1 1

3 3 3

4 4 4

5 5 5

e.

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?

7.

Do you feel future activities on this subject matter are necessary and/or important?

Not committed Yes

1

2

3

4

5 Very committed

No

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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.

Continuing Education Quiz Questions From A to Z: Clinical Pearls for the Acute Care Pharmacist. Part 1 ACPE UAN#0100-0000-14-017-H01-P 1. A “clinical pearl” is best intended to: a. convey one idea, concept, fact, or other information that a clinician has found useful in day-to-day patient-care, but may not be widely known, understood, published, or taught. b. convey multiple ideas, concepts, facts, or other information that a clinician has found useful in day-to-day patient-care and is widely known, understood, published, or taught.

2. In the United States, a rare disease is defined as a disorder affecting less than how many individuals? a. 1,000 b. 150,000 c. 200,000 d. 1,000,000 3. Which of the following electronic resources provides a method for patients with similar rare diseases to communicate via RareConnect (a Facebook like component)? a. Genetic and Rare Diseases Information Center (GARD) b. National Organization for Rare Disorders (NORD) c. Canadian Organization for Rare Disorders (CORD) d. Rare Diseases Europe (EURORDIS) 4. Which of the following electronic resources provides a rare disease database that includes monographs for over 1,200 rare diseases? a. Genetic and Rare Diseases Information Center (GARD) b. National Organization for Rare Disorders (NORD) c. Canadian Organization for Rare Disorders (CORD) d. Rare Diseases Europe (EURORDIS) 5. In regards to potassium iodide use in a nuclear exposure incident: a. Potassium iodide should be administered within 4 hours of exposure. b. Potassium iodide can cross the placenta. c. The pediatric dose of potassium iodide is one-half the adult dose. d. All of the above

7. Many of the antidotes needed for nuclear materials exposure are stocked and maintained in a hospital pharmacy’s inventory. a. True b. False 8. Which of the following is the most accurate definition of an acute massive pulmonary embolism? a. Embolism occurring at the bifurcation of the main pulmonary artery (i.e. a saddle PE) b. SBP less than 90 mm Hg or a sustained decrease of greater than or equal to 40 mm Hg from baseline c. Mean pulmonary artery pressure greater than or equal to 20 mm Hg d. Baseline Miller index greater than or equal to 17/34 9. M.H. has just been diagnosed with a saddle pulmonary embolism. He is a 62 yo male with a medical history of diabetes and a recent intercontinental flight. His current weight is 90kg.

Shortly after returning to his room from the CT scanner he becomes unresponsive. Treatment for pulseless electrical activity (PEA) is initiated and after 1 cycle of CPR a pulse is detected.

Which of the following is the most appropriate regimen for treatment of a confirmed pulmonary embolism in M.H.? a. Enoxaparin 1 mg/kg by subcutaneous injection b. rt-PA (Alteplase) 50 mg IV over 15 minutes c. Heparin 80 units/kg IV bolus followed by 18 units/kg/hr d. rt-PA (Alteplase) 100 mg IV over 2 hours e. Streptokinase 250,000 units IV over 30 minutes followed by 100,000 units/hour for 24 hours 10. All patients with code arrest should be given alteplase 50 mg IV over 2 minutes. a. True b. False

6. Which of the following medications are classified as chelating agents? a. Ferric hexacyanoferrate b. Diethylene triamine pentaacetic acid (DTPA) c. Potassium iodide d. A and B

ANSWER SHEET AND EVALUATION FOR THIS HOME-STUDY ACTIVITY ARE ON PAGE 42.

Spring 2014 • Arizona Journal of Pharmacy • 43

Continuing Education Quiz Questions Bipolar Disorder: A Pharmacotherapy Management Overview 1. What are non-pharmacologic therapies that can be used in the treatment of bipolar disorders? a. Health maintenance b. Mood charting c. Combination of pharmacotherapy and psychoeducation d. All of the above 2. What is/are first line treatments for severe cases of manic phase of bipolar, which includes acute manic, hypomanic, or mixed? a. Lithium b. Valproate c. Lithium and antipsychotics d. Carbamazepine 3. What is/are first line treatments for bipolar depression? a. Lithium b. Quetiapine c. Lamotrigine d. A or C 4. What is/are first line treatments for rapid cycling and maintenance treatments? a. Lamotrigine b. Lithium c. Valproate d. B or C 5. What is the target serum concentration for lithium to treat acute episodes? a. 0.6-1.2 mEq/mL b. 1-1.2 mEq/mL c. 1-1.6 mEq/mL d. 0.5-1.5 mEq/mL 6. What pregnancy category is valproate? a. A b. B c. C d. X 7. Carbamazepine can autoinduce its own metabolism via which CYP enzyme? a. CYP 3A4 b. CYP2C19 c. CYP1A2 d. CYP2C9 8. Patients can experience what type of hypersensitivity reaction with oxcarbazepine? a. Stevens-Johnson Syndrome b. Angioedema c. Toxic epidermal necrolysis d. A or B 9. Your patient was recently started on lamotrigine and lorazepam for his bipolar therapy. A few days later, he developed a skin rash and called to ask for your opinion. What should you tell the patient? a. Advise the patient that it is a common side effect and to continue the medication regimen. b. Advise the patient to discontinue the lorazepam because it caused the rash. c. Advise the patient to discontinue the lamotrigine because it may cause StevenJohnson syndrome. d. Advise the patient to take the lamotrigine at a lower dose.

ANSWER SHEET AND EVALUATION FOR THIS HOME-STUDY ACTIVITY ARE ON PAGE 42.

ACPE UAN#0100-0000-14-018-H01-P

10. Your patient’s mood episodes did not improve with his antidepressants and was started on olanzapine/fluoxetine. What counseling points should you go over? a. Common side effects include weight gain, increased appetite, and dry mouth. b. He should avoid concomitant use with lithium because it may lead to serotonin syndrome. c. He should monitor his blood pressure and liver function test while on this combination. d. All of the above.

11. Quetiapine was recently added to JR’s medication therapy. How will you counsel on this medication? a. Common adverse effects include agitation, dizziness, and somnolence. b. He needs to monitor his fasting lipid profile. c. His family members do not need to monitor him for suicidal ideation because it is not commonly known to cause suicidal thoughts and behavior. d. A and B 12. AM recently started breastfeeding her infant.

Which of the following is correct? a. She should continue her lithium regimen. b. She should maintain a normal sleep patterns to avoid precipitating manic episodes. c. She should add valproate and lamotrigine to her regimen. d. She should take her lithium at a lower dose.

13. KK is pregnant. How should you manage her bipolar therapy? a. Ultrasound examination should be done at 5 week gestation to detect cardiac abnormalities. b. Serum level of medications should be monitored throughout the pregnancy due to fluid changes. c. No lab monitoring is needed. d. At the 20th week of gestation, a maternal serum of α-fetoprotein screening for neural tube defects is recommended. e. B and D 14. What is the difference between Bipolar Disorder I and Bipolar Disorder II? a. Bipolar disorder I presents with manic, or rapid cycling episodes of mania and depression, while bipolar disorder II presents with a chronic state of cycling between hypomanic and dysthymic episode. b. Bipolar disorder I presents with manic, or rapid cycling episodes of mania and depression, while bipolar disorder II presents with recurrent depression accompanied by hypomanic episodes. c. Bipolar disorder I presents with recurrent depression accompanied by hypomanic episodes, bipolar disorder II presents with manic, or rapid cycling episodes of mania and depression. d. Bipolar disorder I presents with recurrent depression accompanied by hypomanic episodes, while bipolar disorder II presents with a chronic state of cycling between hypomanic and dysthymic episode.

44 • Arizona Journal of Pharmacy • Spring 2014

15. What is the difference between a manic and a depressive state? a. A major depressive disorder includes depressed mood and lack of interest or pleasure in normal activities for at least 2 weeks, while a manic episode consists of grandiosity and excessive involvement in pleasurable activities for at least 1 week. b. A major depressive disorder includes depressed mood and lack of interest or pleasure in normal activities for at least 2 weeks, while a manic episode consists of grandiosity and excessive involvement in pleasurable activities for at least 4 days. c. A dysthymic disorder includes depressed mood and lack of interest or pleasure in normal activities for at least 2 weeks, while a hypomanic episode consists of grandiosity and excessive involvement in pleasurable activities for at least 1 week. d. A dysthymic disorder includes depressed mood and lack of interest or pleasure in normal activities for at least 2 years, while a manic episode consists of grandiosity and excessive involvement in pleasurable activities for at least 1 week.

16. Which of the following are true regarding SSRIs? a. Citalopram can cause QT-prolongation and max dose for all patients should not exceed 40 mg/day and should not exceed 20 mg/ day for patients over 60 y.o., have hepatic impairment, or are taking a CYP 2C19 inhibitors. b. There is a Black Box Warning of increased suicidal ideation with antidepressant use. c. SSRIs should not be abruptly discontinued due to withdrawal effects. d. All of the above.

17. Which of the following are true regarding MOAIs? a. MAOIs can be used as a 1st line therapy for the treatment of depression. b. MAOIs can be taken with food containing tyramine if they are separated by 2 hours before and 2 hours after. c. MAOIs are contraindicated with other antidepressants due to increased risk of hypertensive crisis. d. MAOIs does not have a Black Box Warning like the other antidepressants.

18. Which of the following is true regarding antidepressants? a. Bupropion is contraindicated in seizure and eating disorders. b. Abrupt withdrawal effects with venlafaxine may be less serious than with SSRIs. c. Fluoxetine needs to be tapered down when being discontinued. d. Concomitant use of citalopram or escitalopram with carbamazepine does not require dose adjustments since the drugs do not interact with one another

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