AJP Winter 2014

ARIZONA JOURNAL OF PHARMACY THE OFFICIAL PUBLICATION OF THE ARIZONA PHARMACY ASSOCIATION BROUGHT TO YOU BY PHARMACY NETWORK OF ARIZONA

WINTER 2014

2.5 hours of CE Credits INSIDE!!

Reaching New Heights in Patient Care W 2014 • A inter

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Journal of Pharmacy • 1

48th Annual Southwestern Clinical Pharmacy Seminar February 20-22nd 2015 JW Marriott, Tucson

Friday Feb 20th Anticoagulation Certificate

Saturday & Sunday Earn up to 12 CE credits!

Register today azpharmacy.org/events Early bird pricing ends January 16th Arizona Pharmacy Association

YOUR HOLIDAY SHOPPING CAN Support Pharmacy Education

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Arizona Journal of Pharmacy

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

Vol. 6, No. 4

Winter 2014

In This Issue ....

Message from Leadership

Special contributions

A Look Back - Antacid Container

Time Capsule Pharmacy Days of Future Past APhA Awards marketing

4 11 11 12 13

/ tech trends

Tweet Medicine

14

Features Curriculum Mapping Approach to Identify Common Interprofessional Education Content How Perspective Can Change IPPE Rotation

16 22

Departments Association News New Members

PAPA Legislative Update Technician Spotlight

Drug Information Question Academy News: • ACCP Academy • Community Practice Academy • Geriatric Care Academy

• Health-System Academy

• Managed Care Academy

• Student Pharmacist Academy • Technician Academy Continuing Education:

Anemia and the Role of the Pharmacist Review of Common Drug-drug and Food-drug Interactions Associated with Cardiovascular Medications

5 5 8 9 10 25 28 28 28 29 29 30 30 31 31 36

Advertisers PTCB PAAS Pharmacy Quality Commitment Pharmacists Life Insurance Rx Armory Rx Relief

www.azpharmacy.org/ajp

Editor

Kelly Ridgway, R.Ph. Chief Executive Officer

Editorial Board

Whitney Rice, Pharm.D. Christi Jen, Pharm.D. Scott Hardy, Pharm.D.

10 24 24 47 21 48

Managing Editor

Rachel Jimenez Marketing & Communications Manager Andrea Burns, Pharm.D. Jaime Baily, Pharm.D. Kalani Anderson, C.Ph.T.

Winter 2014 • Arizona Journal of Pharmacy • 3

Leadership The holiday season is underway and busy schedules abound. We encourage all of you to remember to take a little extra time to breathe, reconnect, celebrate, and relax over the upcoming months. We should be mindful to take care of ourselves, so that we can take care of others.

We have had a busy year at AzPA. The new AzPA Board has had their retreat and their first board meeting.

The Board has established their strategic plan for the year and is moving towards meeting their goals already.

We will be supporting and running bills on various topics this session and have received valuable input from some of our members. We appreciate the involvement and passion. Some of the bills are going to require a lot of effort to be successful. Please remember that you are a valuable part of this team and we can always use your assistance. Become involved in our legislative committee or provide a financial contribution to PharmPAC (azpharmacy.org/PharmPAC). All types of support is appreciated. You may contact the AzPA Office for more information.

As we move through the rest of this year and into 2015, we are asking for your input. Let us know of any activities you think AzPA and our members should become involved in. Fill out our quarterly CPE needs assessment surveys to help us plan our next events and journals.

The coming months have multiple opportunities to enhance healthcare education. December is World Aids Month. January is National Blood Donor Month and National Mentoring Month. February is American Heart month. Keep your ears open, check your email and AzPA social media sites, as we will provide resources each month to help promote these causes. We have a tremendous responsibility as healthcare leaders in our communities to educate the public on these and other health issues. Our ability to be educators is one of our greatest assets of our pharmacy profession.

Keep watching our website at www.azpharmacy.org and see what is coming up on the horizon. Don’t miss out on anything. Make sure you sign in and set your profile up and then check back frequently. You will be very glad that you did.

We wish you the happiest and healthiest of holidays. May they be full of peace.

Arizona Pharmacy Association

Kelly Ridgway, R.Ph. Chief Executive Officer Arizona Pharmacy Association

Ann Sears, R.Ph. President AzPA Board of Directors 2014-2015

ASSOCIATION NEWS WELCOME NEW MEMBERS (August - Oct 20th 2014) PHARMACISTS Rita Aghenta Abdulaziz Alhossan Ashley Comstock Teresa Cox Tiffany Gordon Kathy Lin Bum-Jun Oh Charity Olson Stephen Rott Rochelle Shoemaker Monia Tomsah ASSOCIATES Beau Bradley Todd Schrick TECHNICIANS

Anthony Chavez Danielle Higgs Nicky Sarahs

STUDENTS Farhana Alam Jina Bae Christena Boles Fernadette Farin Andrea Gooden Taylor Goodman Casey Hilde Sam Hulsey Oritsematosan Isemede Caroline Joseph Rose Karam Melissa Kelly Kathy Khuu Sunghyun Kim Tuong Lai Betty Lee Sandy Lee Stephen McGinnis Tek Neopaney

Dat Nguyen Thuy-Trinh Nguyen Jennifer Panic Kristin Peterson Tina Pourshams-Manzouri Casey Ringler John Romero Lauren Sanders Kimberly Sassenrath John Sellers Rijan Shrestha Joe Summa Artie Thruston Kelvin Tran Christina Trinh David Truong Vincent Tsang Ruoru Weng Sumaiyya Zehri

VOLUNTEER WITH AzPA

Cheers for Volunteers!

We acknowledge the contributions of the volunteers who have made a difference for our organization.

Grace Akoh-Arrey Valerie Bostel Andrea Burns Lou Caldwell Martha Fankhauser Sophia Galloway Lisa Goldstone Nicole Kitts CIndy Liu Karen Liu Betty Louton Grant Metcalf Ronni Nemeth Claire Rodrigues Kristyn Straw-Wilson Blake Stine MISSION STATEMENT

Become more involved in our profession and our organization.

Join a committee! Visit azpharmacy.org/volunteer to learn more about the following committees.

The Arizona Pharmacy Association is committed to serving and representing all practice settings.

Mentor Connection Program Committee Tony Rondinella - Chair Instructions on how to select a Marce Honkonen - Co-Chair committee: • Visit azpharmacy.org Communications Committee • Login on the right hand side of Whitney Rice - Chair website • Select Manage Profile (on Membership Committee right) Kristyn Straw-Wilson - Chair • Select Edit Bio Dave Manchester - Co-Chair • Scroll to the Volunteer Interests field CE Committee • Check the appropriate Terri Warholak - Co-Chair committee(s) and Save profile Lindsay Davis - Co-Chair Legislative Committee Mark Boesen - Chair

AzPA will foster safe and effective medication therapy, promote innovative practice, and empower its members to serve the health care needs of the public.

VISION Empowering pharmacy professionals to provide optimal patient care.

Stay connected!

Like us on Facebook @AzPharmacyAssociation Follow us on Twitter @azpharmacy The Voice of Pharmacy in Arizona Arizona Pharmacy Association

Big thanks to our Committee Chairs for all their support!

Winter 2014 • Arizona Journal of Pharmacy • 5

Want to see your name in print? Submit an article for the next edition of the Arizona Journal of Pharmacy Quarter Issue Winter 2014 Spring 2015 Summer 2015 Fall 2015 Winter 2015

Content Deadline Oct. 15, 2014 Jan. 15, 2015 March 15, 2015 July 15, 2015 Oct. 15, 2015

Publication Date December 2014 March 2015 May 2015 September 2015 December 2015

View submission guidelines and disclosure statements at azpharmacy.org/ajp then send your article along with a signed disclosure statement to web@azpharmacy.org Arizona Pharmacy Association

Mentor Connection Program

go ment t ors?

Build relationships, further professional networks, and strengthen continuous professional development! This program empowers pharmacy professionals to provide optimal patient care. Participation as a mentor or a mentee is open to all Arizona Pharmacy Association pharmacist (mentor), student pharmacist (mentee), technician and resident (mentor or mentee) members.

Program runs from October - July annually!

Want to participate in the next cycle?

Go to azpharmacy.org/mentor for more information.

Member Referrals

Big thanks to the following individuals for referring friends to AzPA during our October Member-get-amember promotion. We appreciate your support in helping our Association grow.

Kevin Boesen William Lewis Eric Luect Reg Roy Scott Waldrop Thomas M. Davis Refer a Friend today azpharmacy.org/refer Association News

SAVE THE DATE: 2015 EVENTS January

29th: Pharmacy Day @ the Capitol

February

20 - 22nd: Southwestern Clinical Pharmacy Seminar (Registration now open) 20th: Anticoagulation Certificate Program (Registration now open)

April

25th: Women’s Reproductive Health Certificate Progam NEW!

June

25 -28th: Annual Convention azpharmacy.org/events Additional event dates to be determined

Interested in becoming a Sponsor or Advertising at an AzPA event?

Contact: Rachel Jimenez AzPA Marketing Manager rachel@azpharmacy.org 480-838-3385 Receive a 2015 Sponsorship Prospectus Today!

AzPA Frequently Asked Questions

New Year 2015 Drawdown

Make your voice heard by supporting PharmPAC! Participate in our New Year drawdown!

Contribute $100 to PharmPAC to be entered to win one of 10 cash prizes One Winner at $5,000 One Winner at $2,500 Two Winners at $500 Six Winners at $250 *Assuming the receipt of 200 entries. In the event 200 entries are not received, prizes may be reduced proportionally. ** Tickets may be purchased by AzPA members only.

PharmPAC contributions are not tax-deductible.

Make your contribution at azpharmacy.org/PACdraw

by January 16th 2015 Proceeds from drawdown will support AzPA’s 2015 legislative agenda (see page 9 of this journal for more information)

The AzPA Office has gone through some recent staffing and database changes in the past few months. We want to make sure all your questions are answered, and most importantly that you know where to go to resolve any future concerns.

I registered for an event. Can you send me a confirmation of my event registration?

Yes. You should receive a thank you email from us after registering for one of our events. You can also go to azpharmacy.org/memberprofile, (login) and access your event registrations and invoices to print at home.

What is my username / password?

Your username is generally your email. If you have not logged into our website since May 2014, please contact our Office for your new password. 480-838-3385 How do I renew my pharmacist license?

For license renewals please contact the Arizona State Board of Pharmacy at (602) 771-2727 or pharmacy.az.gov Can you send me confirmation of the CE activities I have completed with AzPA? We can send you an unofficial transcript, or you may view /print all completed CE activities on your member profile at azpharmacy.org/memberprofile How do I post a job opening to the AzPA Career Center?

Please visit azpharmacy.org/jobs, you will be required to create an employer account first.

I need more CE credits, what are my options?

Check our Calendar of Events for upcoming live CE programs at azpharmacy.org/events . For online webinar options, visit azpharmacy.org/AzCPE . The last section of these journal includes 2 CE home-study articles FREE for you. Or participate in our Mentor Connection Program azpharmacy.org/mentor Who in the Office can I speak to about ...?

The AzPA staff is committed to assisting you as best as we can. Every staff member is willing to help you with any concern. You may contact a staff member directly by visiting azpharmacy.org/staff Other ways to contact us: Phone: 480-838-3385 Fax: 480-838-3557 www.azpharmacy.org Arizona Pharmacy Association

Winter 2014 • Arizona Journal of Pharmacy • 7

Pharmacists Assisting Pharmacists of Arizona (PAPA) PAIN, SHAME AND RIGOROUS HONESTY

One of recovery’s great spiritual gifts is the courage to live an authentic life.

(Originally published in Recovery Campus magazine recoverycampus.com)

By Valerie Fraser Luesse What’s the difference between joining a church and truly believing? Or, as pastors in my rural Southern Baptist church might put it, “Are you just warming a pew, or do you truly love the Lord?” However you understand or define God, you’ve probably given some thought to the question of authenticity, in faith and in life.

“I grew up going to church and was president of my Methodist Youth Fellowship, but back then I didn’t have that sense of choosing to live by the spiritual principals of forgiveness and love and dealing with resentments and relationships in a healthy way,” said Kitty Harris, PhD, LMFT, LCDC, director of Recovery Science Research at Texas Tech. “Just that opportunity to walk a path that’s filled with compassion and empathy and serenity and, to the best of my ability, to love other people—that has been a huge gift for me.”

Our spiritual discussion began when I shared with Kitty something that has amazed me about the recovery community from day one—unflinching honesty. Let’s face it: If you’re an adult walking the planet, you have regrets—moments you wish you could take back; choices you wish you could change; people you’ve hurt, people who have hurt you; wrongs to forgive and to be forgiven for. However, speaking as someone who has never been involved with recovery, I’m not brave enough to be open about my regrets, and I’m in awe of people who not only possess that courage but exercise it daily.

“A lot of people put their pain and shame on the back burner, but in recovery, you don’t have that option,” Kitty explained. “It’s either going to eat you alive, or you’re going to have to deal with it. So 12-Step programs are all built around what we call rigorous honesty. What’s the first thing that happens in a 12-Step meeting? ‘Hi, I’m Kitty and I’m an alcoholic.’ That’s how everything starts. Number one, it’s humbling. Number two, it’s a matter of owning up to and not being ashamed of what you’ve done, of being able to establish an identity at some level as a person in recovery trying to live a different life.”

She pointed to a line in the 12 Steps which talks about “practicing these principles in all our affairs.” The result is that people in recovery take the principals of honesty, open-mindedness, and willingness that they’ve learned while working steps and try very hard to practice those principals in all areas of their lives.

“It’s a courageous way to live,” Kitty said. “And it’s a very transparent way to live. In a recovery meeting, you don’t talk about the If you or someone you care about is suffering from an alcohol and/or latest movie or television show you saw. You talk about your soul.

You talk about your life. You talk about your pain. You talk about chemical dependency problem... your trauma. So the foundation of recovery, I believe—and one ...help is available. of the reasons it’s so successful and so wonderful for people who find it—is that you build intimate, genuine, authentic, transparent Pharmacists Assisting relationships that sustain you throughout your life.”

Pharmacists of Arizona People outside the recovery community are often surprised “A Partnership in Caring” to hear those in recovery express gratitude for their experience, as Kitty explained: “I think the greatest gift from my own addicContact Lisa Yates, PAPA Program tion and recovery has been the richness of the spiritual principals Administrator at 928.532.2293 or papa@azpharmacy.org that I’ve embraced and lived. There’s a great saying by one of the AA founders, which I’ve remembered throughout my life: ‘Don’t All calls confidential. Caller remains anonymous. let the good be the enemy of the best.’ Without recovery, my life would’ve been good, but it would never have been the best bePAPA cause recovery taught me that it’s not about what I get—it’s about is a program of the Arizona Pharmacy Foundation what I give back. And it’s not about what I become—it’s about who I am.”

LEGISLATIVE UPDATE IMMUNIZATION EXPANSION: Legislation would allow pharmacists to vaccine children 6-17 years of age without a prescription (currently we can administer flu vaccine without a prescription but all other vaccines require a prescription) Background Information: 1. General statistics on Immunization Trained Pharmacist • The number of Immunization Trained Pharmacists in Arizona has increased from 1500 to over 4100 since 2010.

• All 50 states allow pharmacists the authority to administer vaccinations. Currently 23 states allow pharmacists the authority to administer vaccines to children without prescriptions (11 of which do not specify an age).

Only 9 states restrict pharmacists to administering vaccines to patients 18 years and older.

2. Vaccines are among the most cost-effective clinical preventive services and are a core component of any preventive services package.

3. A study conducted in rural West Virginia suggested that convenience was the primary determining factor in mothers’ decisions to take their children to pharmacies for vaccinations. Expanded hours and access to vaccination for patients aged younger than 18 years may ultimately prevent students from missing school for an appointment at a physician’s office only open during school hours.

4. Despite progress, approximately 50,000 adults and 300 children in the United States die each year from vaccine-preventable diseases.

5. Communities with pockets of unvaccinated and under vaccinated populations are at increased risk for outbreaks of vaccine-preventable diseases.

6. Community pharmacies are uniquely positioned to increase immunization rates in the U.S.. Arizona pharmacists continue to be limited in their ability to increase vaccination rates due to the current state laws that restrict the age of patients who pharmacists can vaccinate.

7. Pharmacists should be allowed to practice to the maximum capabilities for their training and degree meanwhile continuing to partner with other health care providers in coordinated efforts to decrease the number of under-vaccinated Arizonians.

8. There is a growing patient demand for health care services that all providers now face as a result of health care expansion under the Patient Protection and Affordable Care Act. Please consider contributing to the Pharmacy Political Action Committee of Arizona (PharmPAC). 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

MEDICATION SYNCHRONIZATON: Legislation will be proposed to remove existing barriers in order to enable patients medication synchronization. This will allow patients to receive prescriptions on the same day each month, avoiding multiple visits to the pharmacy. In addition, this would reduce medication waste and avoid decreased medication adherence.

NCPA/NACDS Model Language An individual or group health insurance policy providing prescription drug coverage in the state must permit and apply a pro-rated daily cost-sharing rate to prescriptions that are dispensed by a network pharmacy for less than a 30 days’ supply if the prescriber or pharmacist determines the fill or refill to be in the best interest of the patient or the patient requests less than a 30 days’ supply for the purpose of synchronizing the patient’s non-controlled chronic medications.

No individual or group health insurance policy providing prescription drug coverage shall deny coverage for the dispensing of a chronic medication that is made in accordance with a plan among the health plan, individual beneficiary or group plan, a practitioner and a pharmacist for the purpose of synchronizing the filling or refilling of multiple prescriptions for the insured. This section shall not apply to medications that are in unit-ofuse packaging for which synchronization is not possible, classified as controlled substances, or have been designated by the state or the U.S. Drug Enforcement Agency as having a high risk of diversion. The individual or group health plan must allow a pharmacy to override any denial codes indicating that a prescription is being refilled too soon.

No individual or group health insurance policy providing prescription drug coverage shall use payment structures incorporating pro-rated dispensing fees.

Dispensing fees for partially filled or refilled prescriptions shall be paid in full for each prescription dispensed, regardless of any pro-rated copay for the beneficiary or fee paid for alignment services.

Mark Boesen AzPA Legislative Affairs Committee Chair legislative@azpharmacy.org Jeff Gray, R & R Partners AzPA Lobbyist Winter 2014 • Arizona Journal of Pharmacy • 9

TECHNICIAN SPOTLIGHT Went Looking for Work and Found a Career

by Kalani Anderson, C.Ph.T

Pamela Koepke (“Pam KEP-kee”) walked into a Fry’s grocery store looking for a job. They asked her if she would be interested in a pharmacy position, and she said “Why not?” Pam soon fell in love with the work because it consistently challenged her and made her think in new ways.

Twenty-four years later, Pam still works for Fry’s pharmacy.

Pamela Koepke, She worked with a great pharmacist C.Ph.T. who helped her study and learn along with other technicians who worked to help her succeed. She spent 10 years apiece at two different locations in the Phoenix Valley before she took on the challenge of being a trainer, which she has done for the last four years. Fry’s has dedicated locations where new technicians are trained before assignment to a specific pharmacy. This is where Pam does the majority of her work, schooling techs in the pharmacy computer system, policies and procedures, and essential knowledge to succeed in their jobs. She still picks up shifts at various stores where she enjoys running into technicians she has trained. One of the most fulfilling aspects she notes about her work is seeing technicians who are sincerely interested and have stayed with Fry’s long-term.

Pam became nationally certified before it was a requirement for working in Arizona. Fry’s offered a significant pay raise that provided the needed motivation, and she says it has certainly paid off. While Pam has not finished college, her experiences as a teacher and trainer have built in her a strong conviction for the importance of education, and she hopes to return to school to finish a college degree, potentially in the sciences which she has come to love.

Pam became a member of AzPA in October of 2013 having heard a lot of good things from other employees at Fry’s and with the encouragement of her employer.

She appreciates the discounts to valuable services that the association offers, and she counts on the Pharmacy Flash to help her keep up to date on current issues in pharmacy. She is able to use the current events she learns in the Flash to help her trainees at Fry’s have a better understanding and appreciation of the pharmacy environment they are becoming part of.

As far as advice to new technicians, she states that a sincere interest in the field, a go-getter attitude, the ability to multi-task, and having good social skills are very important. Developing these skills help the technician focus on their patients which is the number one priority. Getting to know and care for the patient as well as being respectful of co-workers is paramount in Pam’s experience. She has observed throughout her career that those who struggle in these areas are more likely to have been around a long time and have perhaps grown complacent. It is perhaps easy after having “seen it all” to stop proactively seeking to recognize issues that should be discussed with a pharmacist and could significantly impact a patient’s health. It is important to work hard at keeping the patient first and remembering the impact a technician’s work has on that patient. She has noticed that pharmacy managers can have a significant impact in this area as well in setting the tone and helping technicians recognize where they can step in and make a difference.

Outside of work, she enjoys traveling with her fiancé. They often go to the California deserts to ride their quads and explore. In her photograph, she is enjoying the company of her Poodle/Shi Tzu, Buddy, on a recent trip to La Jolla, CA. They enjoy road biking and visiting family in the Mesa area as well. If you would like to contact Pam for networking reasons, feel free to contact her at pam.koepke@frysfood.com.

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:

SPECIAL CONTRIBUTIONS A Look Back - Leech Jar

By Robert E. Kravetz, MD, FACP, MACG, American College of Gastroenterology Bloodletting was practiced for almost every type of illness for almost 2 millennia. It usually took the form of venesection using a knife blade, scarifier, or fleam to open a vein. An easier and more desirable method was the application of leeches. The first Westerner to use leeches was Nicander of Colophon of Greece. By the mid18th century, leeching was widely practiced in Europe, especially France.

Leeches secrete a protein, hirudin, that is an anticoagulant in their saliva. Large quantities of blood could be removed from almost any part of the body using this method. Leeches were removed from the water where they were kept, dried with a towel, and applied to the skin sponged with warm water to increase blood flow.

They simply dropped off after they had their fill of blood.

Because of the huge demand for leeches, their price increased dramatically, and in some cases they were rented out and used over again. The medical demand was so high that they almost became extinct until leech farms were set up to meet the need.

Leeches were kept in special vessels that were filled with water and had perforated tops so that leeches could breathe. Early leech jars were glass and, later, ceramic. They were beautifully decorated, highly prized, expensive collector’s items. The ceramic jar illustrated here is simple but still highly desirable. Physicians would often carry small glass or pewter containers containing a dozen leeches when they made house calls.

Pharmacy Time Capsules

Fourth Quarter 2014 1989 - Twenty-five Years ago: 1964 - Fifty Years ago: • There were 74 accredited colleges of pharmacy • Keflin (cephalothin sodium, Lilly) was the first in the United States (including Puerto Rico). cephalosporin to be marketed in the Unites States.

• The conservative Heritage Foundation published • Luther L. Terry, M.D., Surgeon General of the U.S. “Assuring Affordable Health Care for All Public Health Service, released the first report of Americans,” which called for a mandate to the Surgeon General’s Advisory Committee on purchase health insurance.

Smoking and Health linking cigarette smoking to • Losec (omeprazole) was first marketed in U.S. by lung cancer and other lung problems.

Astra. In 1990, FDA required name change to Prilosec to avoid confusion with Lasix.

By: Dennis B. Worthen, PhD, Cincinnati, OH One of a series contributed by the American Institute of the History of Pharmacy, a unique non-profit society dedicated to assuring that the contributions of your profession endure as a part of America’s history. Membership offers the satisfaction of helping continue this work on behalf of pharmacy, and brings five or more historical publications to your door each year. To learn more, check out www.aihp.org.

Winter 2014 • Arizona Journal of Pharmacy • 11

PHARMACY: DAYS OF FUTURE PAST

By Blake Stine, Pharm.D., Midwestern University College of Pharmacy Glendale, Class of 2015 Patient care is rapidly evolving. Pharmacists, previously an underutilized resource, now have the opportunity for great patient care involvement. The results have been favorable. The patient centered medical home (PCMH) model, defined by the Agency for Healthcare, Research and Quality (AHRQ) is the future; pharmacy has recognized and embraced this philosophy with open arms. The AHRQ breaks down the PCMH into 5 fundamental components: 1. Comprehensive care: A team of providers which include physicians, pharmacists, nurses, and more working to ensure all aspects of healthcare are represented.

2. Patient Centered: The patient’s involvement is critical, a legitimate patient-provider relationship must be a priority at every level of care and with every provider. A “patient’s unique needs, culture, values, and preferences” need to be considered and respected when developing a plan for care.

3. Coordinated Care: Open communication between the patient’s team of providers and other services (hospital, specialist, home-health, and more) are necessary to ensure fully informed decisions are made 4. Accessible Services: Shorter waits and urgent care, increased in-person availability 24/7 access to a form of communication with a member of the provider team are critical.

5. Quality and Safety: All providers being a part of care essentially provides a system of checks and balances leading to improved outcomes and patient safety.

Organizations, such as the Arizona Pharmacy Association (AzPA), American Pharmacy Association (APhA), and the National Alliance of State Pharmacy Associations (NASPA), have advanced the profession of pharmacy through the legislative process.

In the last five years, the rapid success of these efforts has been quite astonishing in narrowing the gap between our capabilities and our utilization. In 2009, HB 2164 granted pharmacists to immunize adults per protocols set by the Center for Disease Control (CDC) vaccine schedule without a prescription. This preventative service quickly gained popularity in the community as a convenient way to receive immunizations. The value brought to healthcare could not be ignored. SB 1298 was passed in 2011. This bill expanded the 18 and up, age limit, to include children ages 6-17 years of age, authorized the administration of vaccines by intern pharmacists, certified by the board, “in the presence and under the immediate personal supervision of a pharmacist” certified by the board, and opened up the eligibility of entering into a collaborative practice agreement with a provider to any pharmacy setting. Earlier this year, the passing of SB 1043 amended the Pharmacy Practice Act-officially declaring pharmacists as medical professionals providing services.

Today, pharmacists, licensed and practicing in Arizona, have independent prescriptive authority for adult immunizations (except yellow fever, rabies, Japanese Encephalitis, Rabies and Typhoid) and flu vaccines for anyone over 6 years of age.

These contributions, although significant, have not been enough to satiate pharmacy. We know the range of our capabilities. We are willing to contribute more. We want off the bench and in the game! Today, Collaborative Practice Agreements (CPA) are the start. A CPA with a provider enables the pharmacist to actively participate in the management of a patient’s health via implementation, monitoring, and modifying drug therapy.

Presently, CPAs are almost non-existent in the community setting due to barriers for reimbursement of services and the number of providers. However, within the Veteran’s Health Administration and Indian Health Services, clinical pharmacists have been monitoring and optimizing patient treatment for chronic conditions for the last 50 years.

Pharmacists who are considering becoming involved in Collaborative Drug Therapy Management (CDTM) must familiarize themselves with the rules and regulations that permit these agreements.

Arizona requires written protocols between a prescriber(s) and pharmacist(s). The prescriber must be a physician or nurse practitioner. The prescriber needs to be one that has made the diagnosis and must have a legitimate provider-patient relationship. These agreements are set up specific to the pharmacist(s) not the pharmacy. Other requisites of the agreement are the inclusion of the specific drug(s) and lab tests that the pharmacist(s) may adjust or order. Authorization to start a drug not currently prescribed must be specified in the protocol. The final requirement in a CPA in Arizona is to list the conditions and events in which the pharmacist must notify the provider.

What other considerations should a pharmacist contemplate when deciding to enter into a collaborative practice agreement? Liability. Pharmacist obsess about details and documentation; we stay up to date on guidelines and develop protocols to prevent adverse drug events, despite all the energy and effort to avoid these situations, but some things we just can’t control. When it happens, where will the finger be pointed? The law assigns blame to the pharmacist if the problem arose as a result of the pharmacist’s action and to the prescriber if the issue came about unrelated to pharmacist intervention. With great power comes great responsibility; pharmacies generally provide liability insurance for their pharmacists, but how much is enough? Looking into purchasing your own coverage would definitely be advised. Luckily, for pharmacists peace of mind is available at a very reasonable price.

Pharmacy: Days of Future Past (continued) We’ve come a long way, but this is an endurance race. AzPA is representing our profession at the State Capitol achieve: • Expansion of pharmacist’s prescriptive authority for all vaccinations to ages 6 and up.

• Regulation of the unfair auditing practices insurance/ PBM are conducting on pharmacies.

• Insurance covered medication synchronization fills to improve patient adherence and convenience.

• To open up insurance networks to allow “any willing provider” to be included in network as long as they are willing to accept the terms of their contract. Stopping the forcing of patients into mail order or specific pharmacies for cost, enabling patients to choose their provider.

The fight for prescriptive authority is not an easy battle to win. Doctors are determined to retain their monopoly of power in patient care, but patient-centered care is the future and pharmacy is leading the charge. We, as a profession, have recognized the limited accessibility to providers, patients endure. We are highly trained and capable of providing much more than presently authorized. For the good of the people, we press on.

References: 1. Chisholm-Burns M, Lee J, Spivey C et al. US Pharmacist’ Effect as Team Members on Patient Care systematic review and meta-analyses. Med Care. 2010;48::923933.

APhA Pinnacle Awards Ceremony The American Pharmacists Association (APhA) Foundation held its 2014 Pinnacle Awards. The recipients were honored September 15, 2014, during a ceremony at APhA headquarters in Washington, D.C. The 2014 Pinnacle Awards program featured the inaugural “Pinnacle Awards Innovations in Pharmacy Practice” lecture at the University of Maryland School of Pharmacy in Baltimore. The awards were presented in three categories: • Individual Award for Career Achievement: Individuals that have demonstrated exceptional leadership in enhancing health care quality and medication use.

Congratulations to: Hae Mi Choe, PharmD, Clinical Associate Professor for Univeristy of Michigan • Group Practices, Health-Systems, Health Care Corporations: This category recognizes a significant scientific contribution and/or quality improvement project. Congratulations to: The Kroger Company • Voluntary Health Agencies, Non-profit Organizations, Associations, Government Agencies and Public/Private Partnerships: Organizations that have demonstrated approaches to assist patients and their caregivers in achieving better outcomes from their medications.

Congratulations to: El Rio Community Health Center

2. Yu J, Shah B, Ip E, et al. A Markov Model of the Cost-Effectiveness of Pharmacist Care for Diabetes in Prevention of Cardiovascular Diseases: Evidence from Kaiser Permanente Northern California. J Manag Care Pharm. 2013;19(2):102-14.

3. Scott MA, Hitch B, Ray L, et al. Integration of pharmacists into a patient-centered medical home. J AM Pharm Assoc. 2011;51:161-6 4. Smith M, Bates DW, BodenheimerT, et al. Why pharmacists belong in the medical home. Health Aff. 2010;29:906-13

Photo credit: Craig Thoburn Photography

For more information visit aphafoundation.org/news-release/7-14-14

5. Giberson S, Yoder S, Lee M. Improving patient and Health System Outcomes through Advanced Pharmacy Practice. A Report to the U.S. Surgeon General. Washington, DC: Office of the Chief Pharmacist, U.S. Public Health Service; 2011.

6. Arizona Pharmacy Act. A.R.S. §§32-1970 and 1974 (2014)

SPECIAL CONTRIBUTIONS

Winter 2014 • Arizona Journal of Pharmacy • 13

MARKETING / TECH TRENDS Tweet Medicine: Clarifying How Communicators Can Use Social Media By: Michael M. Durand As every PR professional knows, the value proposition of Twitter is the opportunity to disseminate small packets of timely information.

But when it comes to using Twitter to communicate information about prescription medicines, the Food and Drug Administration (FDA) seems to be saying, “Don’t bother.”

This is a shame, since according to health research consultants, IMS physicians spend twice as much time using online resources as they do print material, and nearly half of all consumers use smartphones to access health information.

Though it has not closed the door entirely on Twitter as a communications tool for prescription drug brands, the FDA has made it problematic, and its guidance has left some looming questions. Five years ago, the FDA, sensing that social media was profoundly affecting how firms communicate with stakeholders, promised to issue guidelines on how medical-device and pharmaceutical companies could use online social platforms and networks such as blogs, Facebook and Twitter (then in its early days) to communicate with the public and health-care professionals.

True to its word, though a bit tardy, the FDA this year has started issuing draft Guidance for Industry position papers on various aspects of social media and other forms of promotion. This past June, it released its guidance on “Internet/ Social Media Platforms with Character Space Limitations,” with the goal of providing recommendations on how pharmaceutical and medical-device companies could use Twitter, Google Sidelink and other limited-space social tools.

It’s important to mention that companies do not have to follow “guidance documents” from the FDA, but they are like “suggestions” from your boss — most companies pay attention.

Balancing the information Thomas Abrams, director of the FDA Office of Prescription Drug Promotion, offered the following guidance in June: We understand that communicating on electronic Internet sites with character-space limitations can be challenging. But no matter the Internet source used, benefit claims in product promotions should be balanced with risk information.

The bottom line is that the FDA does not see Twitter (for simplicity I will focus on that medium, though the FDA proffers recommendations for Sidelink and other media as well) much differently than they do other, more robust communications vehicles, such as traditional and Internet ads, and they essentially put forth the same guidelines with little consideration for the limits of 140 characters.

Here are their recommendations: • Information must be truthful and reveal material facts about the product. Each tweet must include the intended use of the product. All of this seems fair enough.

• If the firm is including benefit information for a drug or device, it must also include significant risk information within each tweet, and the prominence of the risks should be equal to that of the benefits. At minimum, companies must note the most significant risks associated with the product. This seems reasonable, but it makes each tweet a bit awkward.

• There must be a way to allow easy access to a complete discussion of risks linked to the product, such as including a hyperlink leading to a specific page listing the risks.

This starts to make things more difficult. If the company concludes that the risk and benefit information is too complex and cannot be communicated effectively within the space limitations of Twitter, then the FDA suggests it is best to forgo Twitter as a means of communicating with the public. More journal ads anyone?

Tightening the phrasing By now, you might be wondering if all of these requirements can be achieved within the puny universe of 140 characters? The FDA says they can: Suppose you have a product for mild to moderate memory loss called NoFocus. A tweet might read, NoFocus for mild to moderate memory loss (40 characters used, 100 more available).

While there aren’t any life-threatening risks associated with NoFocus, it can cause seizures in seizure disorder patients. So you have to add that in: NoFocus for mild to moderate memory loss; may cause seizure in patients with seizure disorders www.nofocus.com/risks (117/140 — still within the Twitter limit).

But the FDA also wants companies to include the generic name of the medicine, so there’s more text: NoFocus

(reemberine HCl) for mild to moderate memory loss; may cause seizure in patients with seizure disorders www.nofocus. com/risks (133/140 characters).

So, sure, you can cook up a tweet about the hypothetical NoFocus with characters to spare. But — and this is a big question — in the real world, how many prescription drugs have just one significant risk? The FDA says that the most serious risk needs to be on the tweet itself, and additional risk information needs to be included on a landing page linked to the tweet. But it might be a matter of opinion what the major risks are.

NoFocus (reemberine HCl) for mild to moderate memory loss; may cause seizure in patients with seizure disorders and weight gain www.nofocus.com/risks. One more risk means we are at 150 characters, and compressing the hyperlink is verboten. It won’t work.

Equally important — and by now pretty obvious — is that this hypothetical tweet won’t do the brand any good.

While risk information has always been required in prescription drug marketing materials, devoting half of the communiqué to risk information — especially in such a small space — makes the tweet appear as a message advising against using the medicine.

Simply showcasing the medicine’s name (with the accompanying qualifiers) via Twitter is palpably useless in driving physician or consumer awareness. In theory, there are three circumstances in which Twitter could be helpful in a prescription-drug PR program that are not addressed by the FDA: 1. Twitter could be an effective means of announcing the availability of a new medicine. A brand team could spend its prelaunch phase building a following through a nonbranded category (e.g., diabetes, depression) program, then use Twitter to let its community of followers know about the availability of its medicine at the time of FDA approval.

2. Twitter could be a great way to announce to health care professionals that the FDA has approved a new indication or use for a medicine.

3. Twitter could be a terrific way to announce new clinical-trial data on a medication. It’s not unreasonable even now for company representatives to tweet from medical conferences.

In each of these cases, Twitter could quickly inform interested parties about a medical development, if only by linking to a company news release on the matter. However, the FDA has said nothing in its guidelines about these real-life opportunities, and it is doubtful that pharmaceutical companies will use Twitter for these purposes without some clear signals from the FDA that it is OK. Simplifying the rules The FDA has not commented on the use of Twitter and other short-form social media for unbranded public education and disease-awareness programs. This information would be helpful. Would promotion of a company-sponsored awareness program on the signs and symptoms of major depression via Twitter be acceptable? Could a company promote its support of a program organized by a third party, such as World Diabetes Day, organized by the World Diabetes Federation? The answer to these questions is “probably,” but these are the kinds of things that will keep the lawyers and regulatory-affairs experts up all night.

“I find it a real problem that the FDA doesn’t see Twitter any differently than traditional communications vehicles,” says Leigh Fazzina, a social media strategist and former president of the PRSA Health Academy. “I am hopeful, however, that once the FDA starts carefully listening to, monitoring and analyzing social communications through social media listening and analytics programs, it will become more understanding of what the social sphere is truly like.”

The FDA has taken an important step in trying to clarify how communicators can use social media. It is unfortunate that its guidance did not include more real-life examples that would provide clarity instead of simply introducing more questions.

The FDA is soliciting comments from interested parties on the pros and cons of this suggested policy. Due to the tremendous interest in the topic, the Agency has extended the comment period until Oct. 29. One can send comments directly to the FDA. NEW: Marketing & Tech Trends Section Michael M. Durand is a veteran health care PR practitioner Added to the Journal to give YOU tips on and has held senior management positions at Porter Novelli different ways to communicate with your and Ogilvy. He currently is an industry consultant and teaches patients. Let us know what you think: in the graduate communications programs at NYU and Boston web@azpharmacy.org University.

Article submissions on this Copyright 2014 The Straegist. Reprinted with permission from topic will be accepted! the Public Relations Society of America (www.prsa.org) Arizona Pharmacy Association

MARKETING / TECH TRENDS

Winter 2014 • Arizona Journal of Pharmacy • 15

FEATURES Use of a Curriculum Mapping Approach to Identify Common Interprofessional Education Content By: John Boyer, PharmD, Inpatient Pharmacist, University of Arizona Medical Center; Libby Giesler, PharmD, PGY1 Pharmacy Resident, Methodist University Hospital, Dallas, Texas; Kerry Redman, PharmD, Clinical Pharmacist Consultant; John E. Murphy, PharmD, FCCP, FASHP, Professor of Pharmacy Practice and Science, Associate Dean, The University of Arizona College of Pharmacy Objectives: To identify common course content related to interprofessional competencies in the curricula of the professional colleges on the University of Arizona Health Sciences campus. To determine if sufficient overlap occurs that could provide opportunity to create an interprofessional course based on the common content.

Methods: This descriptive, cross sectional study used a set of interprofessional education (IPE) topics including communication, professional ethics, quality assurance and patient safety, evidence based medicine, and public health to compare the core curricula of the colleges of medicine, nursing, pharmacy, and public health. Syllabi for each required course were analyzed to determine which, if any, of the topics were covered. If needed, professors were contacted for clarification purposes.

Results: Each of the health profession colleges covers all 5 of the general interprofessional topic areas at differing levels of depth. Overall, evidence based medicine was the most covered IPE topic (234 hours) followed by communication (154 hours), public health (134 hours), quality assurance and patient safety (107 hours), and professional ethics (59 hours).

Conclusions: The University of Arizona Health Sciences Campus is capable of developing an interprofessional curriculum based on shared aims among the colleges.

Although unable to identify a specific time period that could be used to teach IPE curricula, an IPE course could potentially be implemented in the first professional year for all the colleges as this was the time the colleges spent the most time teaching IPE topics.

INTRODUCTION Interprofessional education (IPE) has become a common topic of discussion and development at health science campuses throughout the United States and around the world. As pharmacists’ roles in health care have evolved to encompass a larger responsibility in the clinical setting and on health care teams, teaching and providing patient care in an interprofessional environment has also emerged and become a more common practice in colleges and schools of pharmacy. For health care providers to effectively work together, barriers between the health professions need to FEATURES

be removed to allow for safe and effective patient care.

Bringing the various health care professionals together during their education can be an important first step toward this goal. A discussion paper by Stephenson and Richardson proposed using the World Health Organization’s International Classification of Functioning, Disability and Health (ICF) as a framework for interprofessional curricula.1 The ICF promotes collaboration across the healthcare professions and with the patient as a way to deliver individualized patient therapy. The authors proposed that collaboration among the health professions would lead to better patient outcomes and recommended that health profession students develop the knowledge and skills to employ such a framework for practice when they become practitioners.

The Interprofessional Education and Practice (IPEP) program at the University of Arizona (UA) encompasses the students and faculty of numerous colleges as well as health care delivery personnel.2 Using a variety of activities, students, faculty, and various staff are utilized from the colleges at the Arizona Health Sciences Center (AHSC), the James E. Rogers College of Law, UA Department of Communication, the Campus Health Service, the Disabilities Resource Center, as well as the Arizona State University School of Social Work. The IPEP program creates and delivers exercises on medical issues designed to teach and reinforce teamwork, quality, safety and effectiveness through joint learning integrated outside the students’ respective curricula.

Long-term goals of the IPEP leadership are to reduce medical errors and improve patient outcomes by enhancing collaboration among health-care professionals. Various IPE exercises targeted toward these goals are provided approximately twice per semester and focus on different educational levels based on the topic covered. Students learn to articulate the roles and functions of different health and human service professionals. Curran et al., evaluated the perceived impact of IPE sessions on students from various health care fields.

They used an attitudinal survey over 3 years of IPE events to determine what students thought about the sessions and their perceived utility. Their questionnaire consisted of 14 items that accounted for the quality of care and teamwork of health professionals.3 All results

showed a positive correlation between the IPE activities and positive student perceptions and there was a strong inclination toward favoring the opportunity to interact face-to-face with other professionals as opposed to e-learning. The AHSC campus includes medical, nursing, pharmacy, and public health students. Students from each of these colleges participate in various IPEP events with one another throughout the didactic portion of their education, but do not currently take required formal interprofessional classes together. The ability to do so could allow students to more thoroughly see health care related issues from the perspectives of the different professions, recognize the value interprofessional teamwork can bring to patient care, and better prepare them to be effective contributing members of such teams. Unfortunately, the curricula of most health professions colleges and schools tend to be packed with required content, which creates one of the challenges to requiring joint courses.

Curriculum mapping is an approach that can be used to determine the content covered in courses across an entire curriculum to determine whether information is provided to students. Plaza et al., used curriculum mapping to assess and evaluate the UA College of Pharmacy’s core didactic curriculum.4 The purpose of their research was to determine the degree which each of the domains and competencies of the college’s expected curricular outcomes were covered by course content. Students were asked to rate how strongly they felt each domain was intended, delivered, and received, and faculty were asked to respond whether or not they taught content directed to each of the competencies. Responses were topographically displayed based on “intended and delivered” or “intended, delivered and received” to display how strongly or weakly each domain was covered during each of the three years of the didactic portion of the curriculum.

The results allowed the authors to determine inconsistencies between what faculty indicated they were covering and what students perceived they were receiving, as well as any overlaps or omissions in the curriculum. The outcome of the study suggested an overall concordance between the intended, delivered, and received curriculum based on both student and faculty perceptions.

A report by Armayor et al., described the curricular mapping process and the various graphical displays that can be created with gathered data to allow for analysis of: 1) provided learning opportunities; 2) whether there are any holes, sequencing problems, or redundancies; and 3) what assessments are being used in a curriculum.5 The graphs could be manipulated and then reanalyzed to explain where specific problems areas occur in a curriculum and what actions might be needed to resolve identified issues. The purpose of this study was to identify potential opportunities for IPE courses by examining the curricula of the AHSC colleges for content commonality that might be packaged together as interprofessional courses.

FEATURES

METHODS: Project Design This descriptive, cross sectional study used a set of predetermined topics that might be taught to an interprofessional audience of students to determine if the content/topics were covered in the core curricula of the colleges of medicine (COM), nursing (CON), pharmacy (COP), and public health (COPH). After review of the literature, the topics were selected based on the Institute of Medicine (IOM) interprofessional recommendations for healthcare professionals and the Core Competencies for Interprofessional Collaborative Practice.6,7 The broad topics selected were: communication, professional ethics, quality assurance and patient safety, evidence-based medicine, and public health. These topics were broken down further into subtopics (see data collection form in Appendix A).

The Doctor of Medicine, Doctor of Pharmacy, Masters of Public Health, and Bachelor of Science in Nursing programs were the programs selected from the colleges included in this study. Only core didactic courses that students were required to take in order to graduate were included in the review process.

Elective or optional courses were excluded. The decision to sample only the core (required) education for each college was made to ensure that every student enrolled in targeted programs of these colleges could be included in any potential interprofessional education content. Courses taught outside of the health science campus by a faculty member not directly affiliated with one of the colleges included in this study were also excluded. The courses examined were those taught during the 2010-2011 academic year.

Data Collection Procedures A list of each of the colleges’ courses was obtained either through contact with a representative from the college or from the colleges’ websites. Course descriptions were analyzed for subject matter relating to the predefined IPE topics. Syllabi for courses of interest were acquired in a similar fashion. If the syllabi were not available on the website then direct contact was made via email to the coordinator of the course. Investigation of the course syllabus for the predetermined IPE content was carried out using a data collection form (Appendix A). The data collection form was developed to collect pertinent information on courses that had been identified to contain content in one or more of the chosen topic areas.

Once a course taught at any of the four AHSC colleges was identified to contain one of the content/topic areas of interest, either via course title, course description, and/or syllabi review, detailed Winter 2014 • Arizona Journal of Pharmacy • 17

information was then extracted by one of the primary investigators directly from the syllabus content. The course coordinator was contacted when necessary for clarification or additional information.Data gathered on each course included the following: health profession, course title/ number, credit hours, course coordinator/professor name, course objectives/outcomes, days and time course met each week, year taught in curriculum, IPE subject taught, approximate hours spent on IPE content, and teaching approaches used. Information was collected on the type of delivery approaches used to convey the IPE topics by asking the person completing the form to note whether the topic was taught as a lecture or case-based, and whether the students learned in groups independently.

The collection form was filled out by one of the study investigators with or without the assistance of the course coordinator/professor depending on the clarity and comprehensiveness of the syllabus.

Data analysis The collected data were entered into an Excel spreadsheet for analysis. The hours spent on each IPE topic was tabulated to display how much time each college devoted to the topic. Teaching approach and the curricular year the course was taught was also included. To make overlapping subject matter more evident, a unique color was assigned to each IPE topic and a color-coded chart was assembled.

Each course was organized under its respective college along the Y-axis of the table with the X-axis containing the IPE topics. Any course that contained IPE content was shaded in with the corresponding IPE color. Additionally a bar graph was created to depict the IPE topic areas each college taught and how much time was devoted to the topics.

RESULTS After examining required courses, it was found that all the colleges provided content in each of the five IPE topic areas. The lectures or courses at each college that were identified as providing IPE content are shown in Table 1, with the IPE topic area covered shaded on the right side. The COM program is designed in blocks rather than individual classes, with lectures as a component of these blocks. IPE topics were covered in 21 COM lectures in the blocks. The other health profession colleges have course-based programs. At these colleges, IPE topics/content were identified in 15 courses at the COP, five courses at the COPH, and four courses at the CON. The hours each college spent on teaching in each IPE general topic area is depicted in Figure 1 with hours shown in Table 2. As illustrated in Figure 1, the amount of time spent teaching IPE topics by the colleges varied. Professional ethics was the only IPE topic that all colleges spent similar amounts of time teaching, with the COM allotting 15 hours, the COP 7 FEATURES

hours, the COPH 20 hours, and the CON 15 hours. The COP provided the most time focused on Communication (99 hours), Quality Assurance and Patient Safety (80 hours), and Evidence Based Medicine (107 hours). As might be expected, the COPH spent the most time (95 hours) on the Public Health IPE topic area compared to the other colleges. Relative to available units, the IPE topic covered most was Evidence-Based Medicine (224 hours), followed

by Communication (142 hours), Public Health (129 hours), Quality Assurance and Patient Safety (107 hours), and finally Professional Ethics (57 hours). No discernible pattern in the teaching approaches used to deliver IPE content was found and thus, the most popular approaches to presenting IPE topics cannot be reported.

DISCUSSION All four colleges on the AHSC campus taught IPE topics in their core curricula over the 2010 to 2011 academic school year. This is not surprising as the topics evaluated in this study are general, but important, themes in healthcare. The colleges spent variable amounts of time teaching the IPE topics, with the COP providing the most overall. The most time was spent on Communication, Quality Assurance and Patient Safety, and Evidence Based Medicine.

There are a number of possible explanations for the documentation of extensive coverage in the pharmacy curriculum compared to the other colleges. First, the authors of this study were Doctor of Pharmacy candidates familiar with the pharmacy courses and could better account for the actual hours spent on IPE content in the courses identified as covering IPE topics. As for the other colleges, unless a professor was contacted for the information, the actual hours spent on an IPE topic was determined by what was stated in the syllabus. Another factor is that the COP students take at least 50% more didactic units than the other professional colleges. The COP is a four-year program where the first three years are focused on core classes with only two electives and the last year is spent on clinical rotations. The courses in the COM are taken in blocks and students take these blocks only in their first two years, with their last two years spent in clinical rotations. The CON is an integrated two-year didactic and clerkship program and the Masters in Public Health is a two year program, with additional required coursework that varies among tracks after the five course core that all students must take. Since all students would only take the five core courses, these were the only ones included in the analysis of the COPH. Thus, the COP has considerably more opportunity and time to cover IPE topics. The COPH and the CON had the least number of core units out of the four colleges.

Students may learn these topics and content in other courses or rotations in their respective curricula outside of core courses. For example, medical students may learn

Table 1

COLLEGE OF MEDICINE† Advanced Topic, Delivering Bad News Bioethics and ID Clinical Trial Design and Statistics Disruptive behavior/Error reduction/ Patient safety Duty to Warn EBM: Statistical Inference EBM: Basic Statistics End of Life Ethics EBM: Study Designs Global Health Through Life Cycle Humanism and Transplant Ethics Humanistic Care in the ICU Intro to Personal and Professional Development Medical Issues of LGD Population Motivational Interviewing 1 Personal and Professional Development: Stress Professionalism Professionalism Across Your Career Spirituality and Health Professionalism Intro US-Mexico Border COLLEGE OF PHARMACY PhPr 843 Law PhPr 895 Preparation for Rotations PhPr 863a QI and Medication Error Reduction PhPr 863c Drug Literature EvaluationsApplications PhPr 863b Quality Improvement and Medication Error Reduction Lab PhPr 812 Nonprescription Drugs and Medical Devices PhPr 861b Drug Literature EvaluationResearch Design Considerations PCOL 820 Case Studies in Pharmacology PCOL 821 Case Studies in Pharmacology PhPr 804 Patient Communication PhPr 816a Patient Assessment PhPr 861a Drug Literature Evaluation PhPr 887 Individualized Medicine, Applied Pharmacogenetics PhPr 818 Basic Principles of Medication Adherence PhPr 845 Medication Use and the US Healthcare System COLLEGE OF PUBLIC HEALTH CPH 577 Sociocultural and Behavioral Aspects of Public Health CPH 573a Basic Principles of Epidemiology CPH 576a Biostatistics in Public Health CPH 575 Environmental and Occupational Health CPH 574 Public Health Policy and Management COLLEGE OF NURSING Nurs 356 Foundations of Nursing Care Nurs 379 Scholarly Inquiry in Evidence Based Practice Nurs 478 Nursing Leadership and Management in Health Systems Nurs 473 Population Health and Community Nursing

Commun- Professional ication Ethics X X

Quality Assurance and Patient Safety

X X X X

X X X

X X

X X

X X X X

X X X X X X

X X

X X X X

X X X X

X

X X

X X X X

X

X

X

X

X

X X

X

X X

X

X

X

X

X

X

X

X

X X

X

X X

X

†COM presented topics in lecture format as part of themed blocks a. Based on review of lecture topics in course syllabi

FEATURES

X

Evidence Based Medicine Public Health

X X X X

X X X X

X

X

X

X

X X

X

X

X

X X

X X

X

X

X

X

IPE topics during clinical rotations, but clinical rotations were not included in the evaluation. It is also possible that these topics are integrated in some coursework rather than being taught as a stand-alone lecture that could be readily identified as one of the IPE topic areas.

The IPE content was likely underrepresented for the COM due to being integrated in the blocks. Since data collection primarily relied on course descriptions, lecture titles, and course objectives provided in syllabi, it is difficult to totally capture the actual time spent teaching these content areas without surveying individual faculty.

Since each of these general IPE topic areas and content are taught in all the colleges, it may be possible to develop a course or courses dedicated to teaching one or more of the content areas using interprofessional approaches. All colleges cover sufficient content in communications, ethics, and safety so that at least a two-unit course could be developed around this content. If an IPE course were developed, the time that each college puts toward covering these topics could instead be used for the interprofessional coursework. A challenge to this proposal, and an often noted difficulty in creating IPE coursework, is that each program is designed so differently that coordination would be difficult and finding a time that would fit for each college may prove problematic. Asynchronous and e-learning approaches could potentially be used to overcome the common time challenges, but it is important to note that students have been shown to have some preference for face-to-face time.

Thus, both teaching approaches should be considered when courses are developed.4 As the professional programs of the colleges are so varied, a set time in the curricula to teach IPE content could not be readily identified. However, most

Winter 2014 • Arizona Journal of Pharmacy • 19

IPE topics were covered in the first professional year for all though the first professional year for all the colleges the colleges, perhaps because they are often foundational appears to be most appropriate. Ultimately, an and the first professional year tends to have introductory interprofessional course is an opportunity to help unite courses, where topics such as these are taught. Thus the the professions toward a common goal of improving first professional year may be best suited for the patient care outcomes by helping students gain implementation of an IPE course on the AHSC campus. understanding of the other healthcare professions and Placing these activities in the first year might also yield the begin collaborations that would facilitate their transition best outcomes in removing stereotypes or preventing their into real-world interprofessional teams that could prove development as well as beginning the processes of working essential for delivering high quality patient care. together. Interprofessional relationships that are developed Table 2: Amount of time spent on each IPE topic per college (in hours) early may continue as well.

Professional Quality Assurance and Evidence-Based Public While the results of this study are limited to the AHSC Communication Ethics Patient Safety medicine health colleges, other institutions looking to analyze their extent 9 15 4 5 5 COM of teaching IPE topics could use this approach. The content 99 7 80 107 14 COP examined for this study was believed to be that which is 23 20 15 96 95 COPH fertile for, and likely to provide a reasonable representation 11 15 8 16 15 CON of, IPE approaches to patient care. However, merely sitting 142 57 107 224 129 Totals students next to each other in a didactic lecture will likely a. Required unit hours per program have limited impact on desired outcomes. The approaches used to deliver the content must foster the intentions of IPE 1 that help students learn the value of other professions, good communication, and teamwork to improve patient care. The Figure 1: Hours Spent Per College on IPE Topics IPE core competencies that were recently developed in a collaboration of all the health profession academic 120 organizations that represent the AHSC colleges (as well as 100 COM others) serve as a model for the future. Due to the broad 80 COP representation of professions in the development of the 60 COPH competencies, there will certainly be ever-increasing 40 CON emphasis on IPE in accreditation standards that will likely 20 lead to requirements for IPE at all the health professions 0 colleges.

CONCLUSIONS This study demonstrated that the curricula of each college on the AHSC campus provide time for teaching the IPE content evaluated. Based on this it appears that a course or courses could be developed to teach the IPE content interprofessionally, with the hope to switch for time where the content is currently taught uniprofessionally. A specific period of time that could be used for an interprofessional class to teach IPE content was not specifically identified, FEATURES

Public health

Evidence based medicine

Quality Assurance and Patient Safety

Professional Ethics

Assumptions and limitations of the project The study results were limited to the specific degree programs at the AHSC professional colleges and might not be generalizable to other health profession universities.

Coding of the data was limited by the researchers’ interpretation of the course description and syllabi as well as the researchers’ opinion on the degree of harmony between course content taught and congruence with the IPE topic areas and content. The accuracy of the syllabi as well as the subjective responses of the professors who were contacted for additional input was an additional potential limitation.

Communication

Hours

a

Column 1 = COM, Column 2 = COP, Column 3 = COPH, Column 4 = CON

1

REFERENCES 1. Stephenson R, Richardson B. Building an interprofessional curriculum framework for health: a paradigm for health function. Adv Health Sci Educ Theory Pract. 2008;13(4):547557.

2. IPEP: Interprofessional Education and Practice. http://ipep.arizona.edu. Accessed 2012 August 28.

3. Curran VR, Sharpe D et al. A longitudinal study of the effect of an interprofessional education curriculum on student satisfaction and attitudes towards interprofessional teamwork and education. J Interprof Care.

2010;24(1):41-52.

4. Plaza CM, Draugalis JR, Slack MK, et al. Curriculum mapping in program assessment and evaluation. Am J Pharm Educ. 2007;71(2):article 20.

5. Armayor GM, Leonard ST. Graphic strategies for analyzing and interpreting curricular mapping data. Am J Pharm Educ.

2010;74(5):article 81.

6. Institute of Medicine. Health Professions Education: A Bridge to Quality. Washington, DC: The National Academies Press, 2003.

7. Interprofessional Education Collaborative Expert Panel. (2011) Core competencies for interprofessional collaborative practice: Report of an expert panel. Washington, D.C.: Interprofessional Education Collaborative.

APPENDIX A. Identifying Areas of Commonality for an Interprofessional Curriculum on the University of Arizona Health Sciences Campus Please email responses or questions to any of the following individuals: Kerry Redman redman@pharmacy.arizona.edu, Libby Giesler giesler@pharmacy.arizona.edu, or John Boyer jboyer@pharmacy.arizona.edu Health profession:  Nursing  Medicine  Pharmacy  Public Health Professor’s name: Course title/number/units: Learning Objectives/ Outcomes: Day and time of week met: Year in curriculum taught:  First Year  Second Year  Third Year  Fourth Year Interprofessional Education Topic

Communication

Professional Ethics

Quality Assurance and Patient Safety

Evidence-Based Medicine

Public Health

Subtopic (Indicate all that apply)    

Provider-to-patient Provider-to-provider Health literacy Other: _____________

   

Emergency preparedness Cultural competency HIPAA Other: _____________



 

Identify error in hazards and care Implement safety design principles Mitigate error Other: _____________

   

Clinical research methods Biostatistics Literature evaluation Other: _____________

   

Nutrition Health promotion Disease prevention Other: _____________



Hours spent on topic

Teaching style (groups, individual, lecture, discussion, case-based)

Additional comments:

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Winter 2014 • Arizona Journal of Pharmacy • 21

Attitude vs. Ability: How Perspective Can Change an IPPE Rotation By: M. Scott Hardy, Pharm.D., R.Ph., BCACP; Elena Demyanova, Pharm.D. Candidate 2016: Mark Bank, Pharm.D. Candidate 2016 The transition between first year didactics and IPPEs (Introductory Pharmacy Practice Experiences) can cause any student anxiety, particularly if it’s the student’s first real-world pharmacy experience. Mayo Clinic pharmacy team wanted to find a way to alleviate this anxiety, and in doing so hopefully maximize a student’s learning experience. Enter TED Talks (Technologies, Entertainment, Design). TED is a non-profit organization that houses thousands of lectures, articles and blogs. “Talks” are a series of lectures on various topics, where the speaker shares a novel, progressive, enlightening or simply unique idea. The preceptors at Mayo Clinic decided to integrate these talks into IPPEs, with a hope that this would help make for a smoother transition.

The thinking being that on an introductory pharmacy rotation, attitude is just as important, if not more, than ability. The students were given two TED Talks during the first week and one each week thereafter, and instructed to implement the message of each Talk into their daily routine on the rotation.

The first Talk that was assigned to the students was “The Happy Secret to Better Work” by Shawn Achor. Mr. Achor shared his belief that most people think working harder will lead to greater success, which will ultimately make them happier. He feels that individuals must “reverse this formula,” or this way of thinking, and instead be happier in the present which will naturally lead to success. He believes that only a quarter of a job’s success depends on I.Q., while the rest is dependent on “one’s level of optimism, social support and an ability to see stress as a challenge instead of a threat.” He calls this the “Happiness Advantage,” meaning the brain performs better when the person is happy. He provides five ways to “re-wire” or train the brain to look for the positives in life, instead of the negatives. First, he says, you should write down three things you are grateful for each day for 21 days.

Secondly, you should journal one positive experience at the end of each day. This will allow the brain to relive this positive experience, which helps to train it to be positive. Thirdly, we should exercise, as it teaches the brain that behavior matters. Fourth, he believes that meditating strengthens the ability to focus on one task. Lastly, he states that everyone should carry out one random act of kindness each day, such as writing a positive email to someone you know. After watching the talk, the students followed Mr. Achor’s advice. In place of journaling a positive experience, the students would reread emails from nurses, doctors and pharmacists that had thanked them for their efforts. This was meant to motivate, reenergize and remind the students of why FEATURES

they chose pharmacy, which is to provide excellent patient care. When the number of prescriptions to be filled, consultations to be offered or phone calls to answer led to stress, the students would step back, close their eyes and breathe. Even a few seconds of meditating allowed them to re-focus on the most important task at that particular time. Emails were also written to the doctors and nurses as random acts of kindness, thanking them for contacting the pharmacy with a clinical question, and allowing the pharmacy team to be their medication experts in the sometimes overwhelming world of prescriptions. In doing these activities, the students were re-wiring their brains. This did in fact enable the students to be more positive in the present, which put them more at ease, in turn leading to more successful IPPEs. The second Talk of the first week was “How to Make Hard Choices” by Ruth Chang. She discussed the difficulty of making hard choices, where these involve comparing two personal values, rather than say two units of measure. This can be challenging because differentiating between values can often lead to a gray area, and it can be tough to decide which is most valued. The author contends though that these hard choices should empower, rather than cripple us.

They force individuals to utilize “normative power,” which is the power to create reasons to make oneself into whatever type of person they’d like to be, rather than letting the world decide one’s fate for them. In pharmacy practice, students must be mindful that each patient is unique, and their respective values, cultures and needs must be considered when making difficult patient care decisions. While at Mayo, a patient presented to the pharmacy in search of a medication for her rhinorrhea as it was allergy season. She also had cellulose and gluten allergies. Her doctor contacted the pharmacy inquiring if Flonase or Nasonex contained either of these substances. After carefully checking the inactive ingredients, the students realized that many corticosteroids do in fact contain cellulose. This presented a challenge in that the corticosteroid would be the perfect treatment for her rhinorrhea, but not if she could potentially have an allergic reaction. In facing this tough decision, the students reflected on Ms. Chang’s Talk, specifically the idea that difficult decisions should empower individuals to make the choices that shape the person they want to be. It took a good amount of time, but some less desirable alternatives were passed over until the best solution for this patient was found, which was to acquire the medication from a specialty pharmacy that could compound Flonase without cellulose. While it would have been easier to settle on one of the less effective alternatives in the face of a difficult decision, the students instead were empowered by the challenge and decided that they

wanted the final recommendation to be a reflection of them as professionals and people.

Week two brought Ron Gutman’s “The Hidden Power of Smiling.” He shared a quote from Mother Teresa that perfectly captured the essence of his message. She famously stated, “I will never understand all the good that a simple smile can accomplish.” Mr. Gutman also referenced many different studies on smiling. In one study the authors found that there was a correlation between the size of a person’s smile in old year book photos and their current-day well-being and success.

Another showed that the life span of baseball players was longer as their smile in their baseball card got bigger. He even referenced Darwin’s “Facial Feedback Response Theory,” which states that the act of smiling makes us feel better. The students decided to put Mr. Gutman’s theories to the test by incorporating them into their everyday IPPE routine. One way the students did this was by smiling before picking up phone calls to see if this affected the interaction at all. Not surprisingly for anyone who has seen this TED Talk, the students were more pleasant and willing to help the person on the other end of the line when smiling beforehand.

Another way was to smile during each patient consultation. The author shared his belief that smiling makes a person more likable, courteous and competent.

Although as IPPE students they were unfamiliar with many of the medications when counseling, the simple act of smiling seemed to help put the patient more at ease, possibly because the students appeared more likable, courteous and competent. It could also have been because as Mr. Gutman stated, seeing a smile makes others feel better too because they mimic your smile, and this probably causes them to like you more for making them feel good about themselves. Smiling was a simple tool that helped put both the students and patients more at ease, which allowed for better communication and ultimately better patient care.

As the third week arrived, the students were feeling more confident with the commonly dispensed medications, the computer system, and counseling patients. However, while there was a sense of confidence with counseling, there was still some doubt as to whether the message was being conveyed effectively each time. Therefore, the students chose to watch the TED Talk “How to Speak So People Want to Listen” by Julian Treasure. The speaker begins the lecture by listing the seven “deadly sins” of conversation: complaining, judging, gossip, lying, excuses, negativity and dogmatism (confusing opinions and facts). The students learned quickly while on rotation that these conversational ‘sins’ were extremely detrimental to effective communication with patients. For instance, if the student was in a bad mood FEATURES

when counseling, or if they were making excuses as to why a medication was not ready on time, the patient was a lot less likely to engage. Instead, the students implemented Mr. Treasure’s four “cornerstones of speaking,” that form the acronym HAIL. They are honesty, authenticity, integrity and love. The students made sure to be honest with patients, being upfront that they are in fact students, and they don’t know everything. They were authentic by being themselves, thanking patients for any questions they asked, and encouraging them to come back or call if they had any further questions. Integrity is a quality that pharmacists and student pharmacists should have ingrained in them naturally. While the students could have faked their way through consultations if they were unsure, especially as the patients would often have no idea, this was never a consideration because of this innate integrity that each pharmacy student should have. The students showed love by wishing each patient well before they left. At the end of the IPPE, although it was not proven, it was felt that using these four cornerstones of speaking in daily patient interactions increased the number of positive patient experiences.

The hope would be that this could have a positive impact on things like medication adherence, as patients would be more apt to remember the medication consultation if it was a positive experience.

The fifth and final Talk was Elizabeth Gilbert’s “Success, Failure and The Drive to Keep Creating.” The author of the bestselling book “Eat, Pray, Love” talks about the challenge of continuing to write after her book gained immense popularity. She states that her “creativity had to survive its own success.” In order to do this she channeled past rejections, and reminded herself of why she became a writer in the first place, because she loved it, regardless of other’s opinions. She advises the audience to find their true passion and stick with it no matter what successes or failures were experienced. Therefore, the students heeded Ms. Gilbert’s advice and kept pressing forward, through both good times and bad on rotation. Multitasking, patients complaining, and struggling to find answers quickly challenged the students’ commitment and motivation at times.

However, through both the highs and lows the students reminded themselves of why they chose healthcare in the first place, which was their passion for providing the highest quality patient care. They also reflected on how difficult it was to get to this point in their academic careers, and that they had been rejected many times along the way, but these rejections only made them work harder to attain their goal because helping people again was their passion.

TED Talks proved to be a helpful tool on IPPEs as they alleviated student stress, which allowed for a more fulfilling and rewarding learning experience. These five Talks helped the students better understand that it is not just ability, but more often attitude that makes all the difference. It’s as the old saying goes, give a man a fish and you feed him for Winter 2014 • Arizona Journal of Pharmacy • 23

a day; teach him how to fish and you feed him for a lifetime.

Any preceptor can teach a student to do well in a particular setting for a short amount of time, but teaching a student with the help of TED Talks that it is a student’s hunger for learning, sincere passion to help patients and respectful attitude towards other health care professionals that will make them a successful professional, will stay with them their entire career. Utilizing media, like TED Talks, can definitely make students more successful on IPPEs, but also as a future pharmacist and in life.

Online CPE Webinars brought to you by the Arizona Center for Professional Education

References: 1. Chang, Ruth. “How To Make Hard Choices.” TEDTalks, May 2014.

Web. 23 June 2014.

2. Achor, Shawn. “The Hapy Secret To Better Work.”

TEDTalks, May 2011. Web. 24 June 2014 3. Gutman, Ron. “The Hidden Power Of Smiling.” TEDTalks, Mar. 2011. Web. 30 June 2011.

4. Treasure, Julian. “How To Speak So That People Want To Listen.”

TEDTalks, Feb. 2013. Web. 7 July 2014.

5. Gilbert, Elizabeth. “Success, Failure And The Drive To Keep Creating.” TEDTalks, Mar. 2014. Web. 14 July 2014.

& the Arizona Pharmacy Association Your online source for continuing pharmacy education.

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DRUG INFORMATION QUESTION What evidence is available on the use of amitriptyline for preventing migraines?

By Peter Khuu, Pharm.D., and Stacy L. Haber, Pharm.D., Associate Professor, Midwestern University College of Pharmacy-Glendale

Introduction Migraines are sporadic unilateral headaches that are severe and often associated with other symptoms such as nausea and vomiting and sensitivity to light or sound. Migraines are common and affect about 12% of the US population.1 They cause lost productivity, missed days from work, and disability.2 Migraine prophylaxis is often recommended for individuals who have migraines lasting more than 12 hours, have more than four migraines per month, or have migraines that result in significant disability.3 Because the exact pathophysiology of migraines is unknown, various drug classes such as beta blockers, calcium channel blockers, anticonvulsants, and antidepressants are used to prevent them.

Amitriptyline is a tricyclic antidepressant that is commonly used for migraine prophylaxis even though it is only FDA approved for depression. Despite that propranolol, timolol, divalproex sodium, ergotamine tartrate, gabapentin, and topiramate are FDA approved for migraine prophylaxis, amitriptyline is considered to be one of the more effective medications according to the 2012 American Academy of Neurology (AAN) guidelines.3 Although amitriptyline is effective, it is also associated with adverse events such as constipation, dry mouth, sedation, and orthostatic hypertension.4 In a search of Medline, four randomized, active-controlled trials were found that evaluated amitriptyline for migraine prophylaxis.5-8 Clinical Trials In a trial by Bulut et al.5, 76 patients suffering from migraines with or without aura were blinded and randomized to amitriptyline or venlafaxine in a 36-week crossover design. There was a four-week runin period followed by a 12-week treatment period with each drug, with a four-week washout period between treatments. Venlafaxine was dosed as follows: 37.5 mg per day for three days, 75 mg per day for three days, and 150 mg per day for 78 days. Amitriptyline was dosed as follows: 10 mg per day for three days, 25 mg per day for three days, 50 mg per day for three days, and 75 mg per day for 75 days. Patients were asked to record the duration of migraine, the number of attacks,

and the severity throughout the study. There was no clear primary endpoint stated by the authors.

For both groups, there was a significant reduction in duration, number, and severity of migraine attacks during the treatment periods compared to the run-in and washout periods (p<0.01); however, there were no significant differences between the treatments at any point of comparison (p>0.05).

Adverse events were more common during amitriptyline treatment; 42 (80.7%) patients had hypersomnia, 36 (69.2%) had dry mouth, 28 (53.8%) had difficulty concentrating, and 18 (34.6%) had sedation. With venlafaxine treatment, 12 (34%) patients had nausea/vomiting and 18 (34.6%) had tachycardia. The authors concluded that the efficacy and safety of venlafaxine are comparable to amitriptyline for preventing migraine headaches.

In a trial by Dodick et al.6, 331 adults who experienced 3 to 12 migraines a month were randomized to receive topiramate or amitriptyline at 25 mg per day; the dose of both drugs was increased in weekly increments of 25 mg per day to 100 mg per day or a lower maximum tolerated dose. Patients were exposed to a 56-day pre-treatment phase during which they received no medication. This was followed by a double-blind treatment period, which involved 4 weeks of a dose titration, a 22-week maintenance phase, and four weeks of a dose taper. The primary efficacy endpoint was change from baseline in mean migraine episodes per month. Functional disability scores were evaluated in both treatment groups as a secondary endpoint. In the intention-to-treat analysis of the 331 patients (172 received topiramate and 159 received amitriptyline), there was no significant difference in the change from baseline in mean migraine episodes per month between the groups (-2.6 for topiramate and -2.7 for amitriptyline; 95% CI, -0.6 to 0.7). The topiramate group had significantly improved mean functional disability scores during migraines (-0.33 vs. -0.19 for the amitriptyline group; 95% CI -0.3 to 0.0). On average, topiramate users lost 2.4 kg, while amitriptyline users gained 2.4 kg.

Winter 2014 â&#x20AC;˘ Arizona Journal of Pharmacy â&#x20AC;˘ 25

DIQ Topiramate users experienced significantly more paresthesia (29.9% vs. 4.7% of amitriptyline users, p<0.001), while amitriptyline users experienced significantly more dry mouth (35.5% vs. 6.8% of topiramate users, p<0.001). The authors concluded that topiramate was at least as effective as amitriptyline at reducing the mean number of migraines per month. The authors also stated that topiramate was associated with improvements in weight loss when compared to amitriptyline.

In a trial by Keskinbora et al.7, 73 patients who experienced three to 12 migraine episodes per month with pain intensity greater than five on a numerical rating scale were randomized to receive topiramate, amitriptyline, or the combination. Patients were blinded and exposed to a four-week titration period followed by an eight-week maintenance period.

Amitriptyline was started at 10 mg per day and was increased by 10 to 25 mg per day weekly to 150 mg per day if tolerated. Topiramate was started at 25 mg per day and was increased by 25 mg per day weekly to 200 mg per day if tolerated. The primary endpoint was the change in mean monthly migraine frequency, severity, and duration during the treatment period compared to baseline. Patients receiving amitriptyline monotherapy had significantly improved migraine frequency (6.09 at baseline vs. 0.91 at week 12, p<0.001), severity (8.18 at baseline vs. 2.14 at week 12, p<0.001), and duration (28.73 at baseline vs. 4.77 at week 12, p<0.001).

However, there were no significant differences compared to topiramate monotherapy or the combination.

Discontinuation rates due to adverse events were higher in the amitriptyline group (14.2% vs. 8.3% and 4.3% with topiramate monotherapy and the combination, respectively). At week 12, there significantly more adverse events in the amitriptyline group (100% vs. 75% and 42.9% with topiramate monotherapy and the combination, respectively). The most common adverse events for amitriptyline were hypersomnia (54.6%), constipation (45.4%), weight gain (27.3%), and dry mouth (almost all patients). The authors concluded that amitriptyline and topiramate, given alone or in combination, did not differ in reducing the frequency, severity, or duration of migraine attacks.

In a trial by Kalita et al.8, 300 patients who experienced more than four attacks per month were randomized to receive amitriptyline or divalproate ER. Amitriptyline was started at 12.5 mg per day for 2 weeks and then increased to 25 mg per day; some

patients were then titrated to 50 mg per day if needed. Divalproate ER was started at 250 mg per day for 2 weeks and then increased to 500 mg per day; some patients were then titrated to 1000 mg per day if needed. The patients were evaluated at 3 and 6 months after starting treatment. The primary endpoint was greater than 50% reduction in migraine frequency, greater than 50% improvement in overall Visual Analogue Scale (VAS) score, and at least 1 grade reduction in severity. There was a significant improvement in all endpoints for amitriptyline and divalproate ER compared to baseline. At three months, more patients receiving divalproate ER than amitriptyline experienced an improvement in migraine frequency (74.7% vs. 62%, respectively, p<0.02), but the difference was not statistically significant at 6 months (65.3% vs. 54%, respectively, p=0.90). At 3 months, more patients receiving divalproate ER than amitriptyline experienced an improvement in VAS score (80.7% vs. 64%, respectively, p=0.0005), but the difference was not statistically significant at 6 months (69.3% vs. 56%, respectively, p=0.47).

There was no significant difference between the groups in improvement in migraine severity at 3 or 6 months. Amitriptyline produced drowsiness in significantly more patients than divalproate ER at 3 months (47.3% vs. 4.9%, respectively, p=0.001) and 6 months (27% vs. 3.7%, respectively, p=0.02). The authors concluded that divalproate ER is more effective than amitriptyline for migraine prophylaxis at 3 months, but both agents are equally effective at 6 months.

While these studies show that amitriptyline is effective for the prevention of migraine headaches, there are several limitations. The small sample size in the studies by Bulut et al.5 and Keskinbora et al.7 limits the generalizability of the results. Also, the trial by Kalita et al.8 did not evaluate concomitant migraine prophylaxis medications, which may have affected the results. Lastly, the trial by Dodick et al.6 excluded patients who had failed 2 other medications for migraine prophylaxis, so the results may not be applicable to patients with refractory headaches.

Discussion The results of these studies show that amitriptyline is as effective as venlafaxine,

DIQ topiramate, and divalproex sodium for migraine headache prophylaxis. According to the 2012 AAN guidelines, topiramate, divalproex sodium, sodium valproate, metoprolol, propranolol, timolol, and frovatriptan are effective and recommended, while amitriptyline and venlafaxine are probably effective and can be offered for migraine prophylaxis.4 The trials

by Bulut et al.5, Dodick et al.6, and Keskinbora et al.7 were considered in the guidelines. The trial by Kalita et al.8 was published after the guidelines.

In the studies reviewed, amitriptyline was associated with more adverse events, including weight gain, hypersomnia, constipation, and dry mouth.

Additionally, amitriptyline may interact with other medications, including antiarrhythmics, opioids, serotonin modulators, antipsychotics, alpha and beta agonists, MAO inhibitors, and NSAIDS. Amitriptyline should not be used in the elderly and should be used with caution in individuals with bipolar disorder, a history of cardiovascular disease, thyroid dysfunction, and seizures.3 In conclusion, amitriptyline is as effective as other agents for migraine prophylaxis and due to its adverse effects, is a good second-line option for patients with comorbid conditions such as depression, insomnia, or neuropathic pain.

References 1. Lipton RB, Bigal ME, Diamond M, et al. Migraine prevalence, disease burden, and the need for preventive therapy. Neurology.

2007;68:343-9.

2. Ferrari MD. The economic burden of migraine to society. Pharmacoeconomics. 1998;13:667-76.

3. Amitriptyline hydrochloride. Drug facts and comparisons. In: Facts & Comparisons [online database]. St. Louis, MO: Wolters Kluwer Health Inc. (accessed 2014 Mar 31).

4. Bajwa Z, Sabahat A. Preventive treatment of migraine in adults. In: Swanson J, Dashe J, eds. UpToDate [online database].

St. Louis, MO: Wolters Kluwer Health Inc. (accessed 2014 Mar 31).

5. Bulut S, Berilgen MS, Baran A, et al. Venlafaxine versus amitriptyline in the prophylactic treatment of migraine: randomized, double-blind, crossover study. Clin Neurol Neurosurg.

2004;107:44-8.

6. Dodick DW, Freitag F, Banks J, et al. Topiramate versus amitriptyline in migraine prevention: a 26-week, multicenter, randomized, double-blind, double-dummy, parallel-group noninferiority trial in adult migraineurs. Clin Ther. 2009;31:542-59.

7. Keskinbora K, Aydinli I. A double-blind randomized controlled trial of topiramate and amitriptyline either alone or in combination for the prevention of migraine. Clin Neurol Neurosurg.

2008;110:979-84.

8. Kalita J, Bhoi SK, Misra UK. Amitriptyline vs. divalproate in migraine prophylaxis: a randomized controlled trial. Acta Neurol Scand. 2013;128:65-72.

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/PTCPprep to register. *Class requirements: Internet connectivity, Windows Media Player and Adobe Acrobat Reader are required for participation in this class.

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 azpharmacy.org/Law_Textbook

Winter 2014 â&#x20AC;˘ Arizona Journal of Pharmacy â&#x20AC;˘ 27

Academy News American College of Clinical Pharmacy Arizona Chapter Academy News It is with great honor to announce that the American College of Clinical Pharmacy has a new Arizona Chapter. As a teaching and research based organization, we aim to perpetuate knowledge and inspire learning. More specifically, we aim to introduce a canon of clinical works through writing and ask the reader to articulate their reactions, not only presenting a repertoire of ideas but also teaching independent critical listening and thinking. To this end, the ACCP Arizona seeks a balance in research between writing and asking pharmacists to make discoveries. As President I encourage the reader to engage with the topic at hand, with me, and with each other in the belief that good teaching depends upon intellectual exchange. Through lectures, discussions, and clinical writings, show that pharmacy responds to various modes of inquiry: analytic, hermeneutic, cultural, and historical; thus, the reader is equipped to explore the possibilities of each perspective and emboldened to push beyond their own experience to expand their skills. In the end, I hope to have enriched a reader’s ability to think about and discuss pharmacy with a new awareness of its aesthetic and humanistic M. Scott Hardy, PharmD, BCACP significance.

ACCP Arizona Academy Chair accp@azpharmacy.org

Community Pharmacy Academy News The healthcare system has been tested in ways unimaginable this year. Who would have imagined that a single case of an Ebola patient entering the United States and creating the potential for infections far and wide would become a defining test of how we are doing in preparedness to deal with infectious diseases? There has been so much discussion in the news, and abundant healthy information for the healthcare practitioner to learn. In a perverse way, the consciousness of the public has awaken and mass education is taking place right before our eyes. What seems to be over-reaction at times, is the public taking interest in learning necessary measures to protect the community from Ebola.

In the absence on a vaccine for Ebola, the need to educate on prevention is paramount. The CDC recommends, the practice of good hygiene, which includes but not limited to the use of alcohol-base hand sanitizers , proper hand wash with soap and water and avoidance of exposure to bodily fluids should be emphasized. In addition, the healthcare professional still has the responsibility of properly educating to minimize unnecessary public anxiety over Ebola; a disease that is not an airborne and only transmits via contact with infected bodily fluids. Check azpharmacy.org/ebola for the latest updates and available resources.

Grace Akoh-Arrey, Pharm.D., CDE, BCACP The pharmacy practitioner must remain aware of their role in the Community Pharmacy Academy Chair community healthcare system as much as other medical professionals, beyond cpa@azpharmacy.org the drug-related traditional roles of the past. With self- education on various techniques of healthcare management, pharmacists continue to take on expanded roles that the public will always depend on.

Geriatric Care Academy News

The GCA had a great year. On Saturday, October 11th, five members of the GCA participated in a Polypharmacy Review at St Luke’s home in Tucson where they precepted pharmacy students, medical students and nursing students from the University of Arizona. The event was well received by the home’s residents and by all students who participated.

We enjoyed the opportunity to network with other pharmacists in the state during AzPA’s Fall Conference in Phoenix last month. The conference hosted a variety of CE offerings, including a session on The Pharmacist’s Role in Parkinson’s Disease. Members of the GCA also attended the 2014 ASCP Annual Meeting & Exhibition November 5-7th in Orlando, Florida. GCA members attended the 2014 Mission of Mercy - providing dental services to the uninsured and underinsured - December 12th and 13th.

As a reminder, the GCA meets via monthly conference calls on the second Wednesday of the month at 12:30 pm. I know that not everyone is able to attend these calls, Nicole K. Kitts, PharmD, BCPS, CGP so keep an eye out for additional e-mails and updates from the GCA. I invite Geriatric Care Academy Chair everyone that is interested in geriatrics to get more involved! gca@azpharmacy.org

Health-System Academy News Dear Health System Academy Members, The various HSA committees have been busy on achieving this year’s initiatives. We have several activities and projects currently underway.

ASHP AZ House of Delegates (HOD): We are nominating individuals to serve as an Arizona delegate. To qualify, a nominee must be a pharmacist member of the ASHP residing in Arizona and willing to serve for three consecutive years.

State delegates develop an understanding of the issues on the HOD agenda, learn the perspectives of ASHP members in Arizona, particapte in a Regional Delegate Conference and in the House of Delegates session at the summer meeting reporting session outcomes back to state ASHP members. Delegates, who are concurrent members of the AzPA, are expected to participate in the AzPA Legislative Committee for the length of their term.

Pharmacy Practice Model Initiative (PPMI): AzPA is working with the University of Arizona and Midwestern University’s Glendale College of Pharmacy to improve the ASHP Arizona Hospital Self-Assessment rates by incorporating student assistance in completing this survey at their respective rotation sites. Completion rates of all Arizona hospitals in March 2014 and Sept 2014 were 11% and 17%, respectively. Our goal for next year is to increase completion rate >25%.

Annual Southwestern Clinical Pharmacy Conference Feb 20-22, 2015 in Tucson: We are currently planning the conference in collaboration with the University of Arizona.

The Health-System Academy of the Arizona Pharmacy Association is the Arizona affiliate of the American Society of Health-System Pharmacists (ASHP).

Mitchell Buckley, FASHP, FCCM, BCPS Health-System Academy Chair hsa@azpharmacy.org

Managed Care Academy News The academy has had a great beginning. Ideas and future topics abound for upcoming conferences along with suggestions on holding our first networking event for fellow Managed Care Partners.

The Managed Care Academy once again hosted a meet and greet event at the AMCP Nexus conference this past October. We will hold another meet and greet event in San Diego this coming April. Please join us for an exciting and fun conference to learn more of upcoming trends in our field. We are very excited.

Watch for emails for more information.

We look forward to hearing from our AzPA members for your suggestions, ideas and topics that will help our association grow in improving our healthcare. So don’t forget to join us, Managed Care Academy for our monthly phone conferences every 3rd Thursday of the month at 7am.

Paul Lynne, Pharm.D.,

Managed Care Academy Chair mca@azpharmacy.org

JOIN AN ACADEMY TODAY! • • • • • • •

Visit azpharmacy.org Login on the right hand side of website Select Manage Profile (on right) Select Edit Bio Scroll to ‘AzPA Academy Affiliation’ field Select the appropriate academy You may also choose a secondary academy

Arizona Pharmacy Association

Once you have selected an academy, you will begin to receive academy meeting emails / invites.

Questions? Please contact the AzPA Office 480.838.3385 ACADEMY NEWS

Winter 2014 • Arizona Journal of Pharmacy • 29

Student Pharmacist Academy News U of A held a successful membership drive this quarter! To celebrate Pharmacy month, we paired up with our pediatric pharmacy organization - Pedicats - to reach out to pre-pharmacy students, offering support and fostering their efforts to get into pharmacy school. We plan to host several Katy’s Kids events in conjunction with Pediacats and also with Banner Children’s Hospital. We are also selling class t-shirts this year alongside a new design for UA alumni. Crane Davis, Fry’s pharmacist and AzPA member, joined for our November meeting to discuss personal branding and ways to make strides for the pharmacy profession during our future careers. We also held our Change for Change campaign to raise money for the PharmPAC encouraging students to write letters to their representatives.

Midwestern University students had a busy year. Pharmacy month (Oct) included two events. Safe Halloween event was held on campus to educate children about safe trick-or-treating. SPA’s booth, specifically, taught the kids that some medicines look like candy, so they should always check with an adult. We were also excited to have AzPA’s Kelly Ridgway and Deb Marcum visit the MWU campus to speak with the students about AzPA and the future of pharmacy in Arizona. Then in November, SPA attended APhA’s Midyear Regional Meeting in Scottsdale as AzPA representatives.

As we move closer to the beginning of a new year, our sights are set on the Pharmacy Day at the Capitol event - held yearly. We will be taking a bigger role in planning it this year with APhA, looking for ways to make it better and increase legislator involvement. It’s going to be a great year for SPA! Nicole Runge, SPA Co-Chair, Midwestern University of College of Pharmacy Glendale nrunge21@midwestern.edu Pearce Engelder, SPA Co-Chair University of Arizona College of Pharmacy engelder@pharmacy.arizona.edu

Technician Academy News Greetings fellow technicians! I hope this season finds you well.

PTCB Re-certification Information: for 2014, one of the 20 required hours of continuing education must be in medication safety. AzPA offered a CE activity to fulfill this requirement at the Fall Conference. For 2015, all 20 hours must be pharmacy technician-specific CE programs. The number of CE hours earned through in-service projects and training (employer in-service under the supervision of a pharmacist) has been reduced from 10 hours to 5 hours maximum for 2015. For more information, see the October 2014 news release on ptcb.org Concerned about CPEs? AzPA website offers many low cost programs specifically for technicians. Live programs will be listed under the Calendar of Events azpharmacy.org/events, or register for online webinars azpharmacy.org/AzCPE . Over the next few months, your Technician Academy will be developing the Continuing Education topics you suggested as well.

Did you know? The Technician Academy has a Facebook Group! Stay connected by joining the group: facebook.com/groups/269817213226042/ If you would like help in any way, or have any questions, please send me an email!

Did you know?

The last section of this Journal contains 2 accredited technician-specific CPE articles.

Read and send your completed evaluation and quiz to AzPA for credit.

ACADEMY NEWS

Reginald Roy, C.Ph.T. Technician Academy Chair tech@azpharmacy.org

CONTINUING EDUCATION Anemia and the Role of the Pharmacist

by Ashlie Kucera, Pharm.D. Candidate Class of 2015; Bethany Smith, Pharm.D. Candidate Class of 2015; Laura Tsu, Pharm.D., BCPS; Midwestern University College of Pharmacy â&#x20AC;&#x201C; Glendale Goal: This home-study CPE has been developed to educate pharmacists and pharmacy technicians about the various types of anemia and their treatments.

Objectives: At the conclusion of this lesson, successful participants should be able to: 1. Identify signs and symptoms of anemia 2. Differentiate between types of anemia and their etiology 3. Perform patient counseling for oral iron therapy, including dosing, drug interactions and side effects 4. List goals of iron therapy 5. Name food sources rich in iron, folic acid and/or vitamin B12 6. Describe treatment of folic acid and vitamin B12 deficiency anemias Introduction Anemia, a condition characterized by decreased hemoglobin levels and an insufficient ability to oxygenate the body, is one of the most common blood disorders in the world.

Globally, it affects over 1.6 billion people; roughly 25% of the world population.1 In healthy individuals, oxygen is adequately transported throughout the body via hemoglobin (Hgb), a protein found in red blood cells (RBCs). RBCs require several nutrients to function properly including iron, folate and vitamin B12. A deficiency in any of these nutrients, alteration of morphology of the cell, increased RBC destruction or excessive blood loss can result in anemia.2 There are numerous causes of anemia including malnutrition, chronic conditions, pregnancy and drug-induced anemia.3 Additional risk factors for anemia include folic acid deficiency, vitamin B12 and autoimmune disorders (Table 1.1).

Healthy patients with anemia may be asymptomatic if their hemoglobin levels decrease slowly over time. Presentation with acute anemia may present as tachycardia or hypotension, while chronic conditions often present with more generalized symptoms like fatigue, weakness or pale skin (Table

1.2).4,5

Diagnosis Although diagnosing anemia may be relatively straight forward, a thorough workup is generally required to identify the etiology of the disorder. Since there are many different causes of anemia it is important to identify the origin of the disorder so that it may be treated correctly and can be prevented in the future. Usually the assessment begins with

a detailed history of the patient, including information such as diet and lifestyle, medical history, family history, current medications and religious practices that may influence their diet.6 Next, a physical exam is performed and several laboratory tests are completed.6 Laboratory tests commonly used for the diagnosis of anemia include a complete blood count (CBC), iron studies, and serum nutrient levels.6,7,8 Table 1.3 contains common laboratory tests used to diagnose anemia and explains what each test assesses.

There are three broad categories of anemia which are differentiated by their mean cell volume (MCV) which measures the size of the RBCs. As depicted in Table 1.3, normal values for MCV range from 80-100 fL/ cell.9 Macrocytic anemias, also known as megaloblastic anemias, have a MCV level greater than these values, and include folic acid deficiency anemia, vitamin B12 deficiency anemia and pernicious anemia.10 Microcytic anemias have decreased MCV values and include iron deficiency anemia. Finally, normocytic anemias have MCV values that are within normal limits, and the RBCs present in these patients are generally unaffected. These anemias are caused by acute blood loss or abnormal blood cell production, such as aplastic anemia or anemia from chronic renal disease.4,11,12 Assessment of a MCV value provides a general classification of the anemia and gives the provider a better idea of what potential causes may be.

Microcytic Anemias Iron Deficiency Anemia: Iron deficiency anemia, a microcytic anemia6, is the most common type of anemia in the world.3 As indicated by its name, iron deficiency anemia is the result of insufficient iron in the blood. There are various causes of iron deficiency, such as insufficient consumption in the diet, malabsorption, heavy menstruation, pregnancy, dialysis and gastrointestinal inflammatory disorders.3,6 On presentation, this type of anemia may differentiate from others with specific signs and symptoms. These signs include tongue soreness or smooth appearance, pica, phagophagia, and/or dry mouth.4 Table 2.1 contains symptoms of specific anemias. Suspicion of iron deficiency anemia is verified via analysis of iron indices and of other labs included in Table 1.3. Patients with iron deficiency anemia will have decreased serum iron, ferritin and transferrin saturation (TSAT) levels and an Winter 2014 â&#x20AC;˘ Arizona Journal of Pharmacy â&#x20AC;˘ 31

Anemia increased total iron-binding capacity (TIBC).7 Additionally, patients with anemia will frequently show hemoglobin levels below 13 g/dL in men and 12 g/dL in women.1 Once a specific diagnosis of iron deficiency anemia has been determined, there are several methods of treatment that can be attempted. Generally, mild iron deficiency can be treated on an outpatient basis with oral iron replacement therapy, with a goal of 200 mg of elemental iron per day. There are currently four oral iron supplements available on the market commonly used for treatment: ferrous gluconate, ferrous sulfate, ferrous fumarate, and polysaccharide iron complex. Table 2.2 describes these oral iron products and their elemental iron content. Of these four, ferrous sulfate is prescribed most commonly and is likely the oral therapy encountered most often in community pharmacies.3 To ensure that patients get maximum benefit out of oral iron therapy, medication counseling should be performed.

Regimens of iron supplements should be divided into two to three doses daily. These supplements should be taken on an empty stomach, an hour before meals or two hours following a meal. Oral iron has been found to have increased absorption when taken with ascorbic acid, so it is often recommended that these supplements be taken with a glass of orange juice.3 Side effects of oral iron therapy are mostly inflicted on the gastrointestinal (GI) tract, and include abdominal pain, nausea, constipation, heartburn and dark stools. It is because of this GI upset that one-time daily dosing should be avoided.13,14,15,16 If the patient experiences GI side effects that are intolerable, it is recommended that the supplements be taken with orange juice and/or food. There are several drug-drug interactions of oral iron supplements that the pharmacist should be cautious of when filling a prescription. Table 2.3 lists these interactions.

To assess response to oral iron therapy labs will need to be monitored. Reticulocyte count, an assessment of the production of new RBCs, should increase within seven to ten days. Hemoglobin (Hgb) and hematocrit (Hct) should also be tracked with an expected increase in Hgb of 1g/dL per week and at least 2g/dL total by three weeks of therapy.6 Educating patients about dietary sources of iron is an important intervention for both treatment of deficiency and for preventing future occurrence of anemia. Meat is a good source of iron, including red meat, chicken, fish and organ meats (i.e. liver). Other sources include beans, green leafy vegetables and enriched breakfast cereals. These non-meat sources contain “non-heme” iron, which have a lower rate of absorption than “heme” iron found in meat. Therefore, it is often difficult for vegetarians to achieve recommended levels of intake of iron. In this patient population, iron-containing dietary supplements may be considered for CONTINUING EDUCATION

prophylaxis.17 In severe cases of iron deficiency anemia, if the patient is unable to tolerate oral therapy or if there is an inadequate response to oral therapy, parenteral iron therapy is indicated.3 There are currently four parenteral iron products commonly used: iron dextran, iron sucrose and sodium ferric gluconate and ferric carboxymaltose.

Table 2.4 describes these products and their recommended doses.

All parenteral iron products have a risk of anaphylaxis, with the highest risk associated with iron dextran. Due to this high risk, a test dose is required prior to administering iron dextran.18 Other adverse effects of intravenous iron include arrhythmias, arthralgia, hypotension, flushing and prurtitis.18,19,20,21 Two formulations, iron sucrose and sodium ferric gluconate, are only FDA approved for the treatment of anemia associated with chronic kidney disease (CKD).19,20 Macrocytic Anemias Vitamin B12 Deficiency and Pernicious Anemias: Vitamin B12 deficiency anemia, a macrocytic anemia, is one of the most common types of anemia in the United States.22 A deficiency of vitamin B12 can be caused by several factors, including diet, malabsorption, alcoholism, or decreased stomach acidity.23 Certain medications can also lead to deficiency such as proton pump inhibitors and metformin. A severe form of vitamin B12 deficiency is called pernicious anemia.

Pernicious anemia is a specific type of anemia that is caused by autoimmune destruction of gastric parietal cells. In healthy individuals these cells produce intrinsic factor (IF) which is required to bind and absorb dietary vitamin B12. When autoimmune destruction of the gastric parietal cells takes place, vitamin B12 can no longer be absorbed and deficiency occurs.24 Specific signs and symptoms differentiate these two types of anemia from others such as numbness, parasthesias and gait disturbances.23 See Table 2.1 for additional symptoms. Development and myelination of the central nervous system requires vitamin B12. Thus, severe deficiency can result in the presence of debilitating neurologic complications.24 Laboratory findings to confirm these types of anemias are decreased serum vitamin B12 levels and IF, normal folate levels, and increased serum methylmalonic acid and total homocysteine levels.8 Once vitamin B12 deficiency anemia has been confirmed, early treatment is important since neurological sequelae can be irreversible if not treated in a timely manner. Treatment options include replacement therapy in a variety of dosage forms, most commonly intramus-

Anemia cular or oral formulations. Generally, parenteral replacement is the preferred method since approximately 10% of these doses are absorbed compared to only 0.5-4% of oral doses.22 For this reason lower doses of vitamin B12 can be given when administered intramuscularly. In order for oral therapy to be effective, high doses must be given. Table 3.1 contains recommended dosing for both oral and parenteral vitamin B12 therapies.22, 24 Lab values and symptoms should be monitored to determine response to therapy. Neurological symptoms and megaloblastic cells should resolve within a few days, in general. An increase in H/H should be noted after about one to two weeks of therapy.24 Replacement therapy is usually long term for patients without pernicious anemia. For those diagnosed with pernicious anemia, lifelong therapy will be required.22 CBC and serum vitamin B12 levels should be monitored over time, at least 1-2 months after initiation of therapy and 3-6 months thereafter.22,24 Side effects of replacement therapy include dizziness, headache, anxiety or nausea.25 Increased consumption of foods rich in vitamin B12 can help alleviate deficiency and prevent future episodes. Meat, fish, poultry, eggs and dairy products are examples of these. As noted previously, increased consumption of nutrients such as this can be difficult for vegetarians and prophylactic dietary supplementation may be indicated.22 Folic Acid Deficiency Anemia: Folic acid deficiency anemia is another common type of anemia in the United States. This macrocytic anemia is caused by diet, alcoholism, pregnancy and lactation, and dialysis. Folic acid deficiency can also be drug-induced and may be due to the use of sulfasalazine, methotrexate, phenytoin, triamterene, or trimethoprim.3,8,10 Unique signs and symptoms of folic acid deficiency are irritability, personality changes, and memory impairment.17 Refer to Table 2.1 for additional symptoms. Confirmation of this deficiency anemia is obtained by lab values of decreased folate levels, and normal vitamin B12, IF and methylmalonic acid levels.10 Treatment of this anemia is usually accomplished with oral replacement therapy. Table 3.2 describes common dosing regimens for folic acid deficiency anemia. Side effects of replacement therapy are generally mild and include malaise, rash and flushing.26 Green leafy vegetables, citrus fruits, dairy and grains are examples of dietary sources rich in folate.17 Normocytic Anemias Acute Blood Loss Anemia: Hemorrhage and acute blood loss results in anemia due to RBC volume depletion. Acute blood loss can occur with GI bleeds, trauma or surgery. Symptoms of acute blood loss are rapid blood pressure decline and dizziness.5 This is CONTINUING EDUCATION

categorized as a normocytic anemia since the existing RBCs are largely unaffected. Hemoglobin and Hematocrit (H/H) are surrogate makers for this type of anemia.

An elevated reticulocyte count in also noted in these patients.17 Refer to Table 1.3 for normal values of these labs. Treatment for acute blood loss anemia is generally a blood transfusion if the loss is substantial, in addition to stopping the source of the bleed.5 Chronic Blood Loss Anemia: Anemia in chronic blood loss results from a slow downward trend of RBC volume. Conditions such as stomach ulcers, diverticulitis, cancers or heavy menstrual bleeding are associated with this type of anemia. Symptoms include fatigue, shortness of breath or paleness.5 Lab values are similar to those of acute blood loss and display decreased H/H values.17 Treatment with blood transfusions for this type of anemia may not be indicated; however supplementation with iron therapy may be used for several months.5 Aplastic Anemia: Aplastic anemia occurs when a bone marrow disorder results in a decreased production of RBCs. Other causes of this type of anemia include radiation and chemotherapy, exposure to toxins, autoimmune disorders, HIV, Epstein-Barr virus, parvo and pregnancy.12 Some medications may also cause aplastic anemia such as phenytoin, carbamazepine, chloramphenicol, felbamate and quinine.17 Symptoms of this type of anemia include fatigue, rapid or irregular heart rate, frequent infections, unexplained bruising, nosebleeds and bleeding gums, and rash.12 Lab values for aplastic anemia show decreased reticulocyte count, white blood cells (WBCs) and platelets.17 For a confirmatory diagnosis a bone marrow biopsy is required. Blood transfusions, stem cell transplant or pharmacotherapies are treatments for this type of anemia.12 Immunosuppresants such as cyclosporine, methylprednisolone, or antithymocyte globulin are examples.12 Bone marrow stimulants including filigrastim and epoetin alfa can also be used as adjunctive therapy with immunosuppresants.12 Therapy with antivirals and antibiotics may be warranted to prevent infections in these vulnerable patients.

Anemia of Chronic Kidney Disease: Patients with chronic kidney disease often exhibit anemia due to decreased production of erythropoietin by the kidneys. These patients often suffer from weakness, inability to concentrate, chest pain, fatigue, and headache.11 Heart failure and tachycardia are common complications of this type of anemia.11 Decreased reticulocyte count and normal or increased WBCs and Winter 2014 â&#x20AC;˘ Arizona Journal of Pharmacy â&#x20AC;˘ 33

Anemia platelets are often seen in this patient population.17 Additional testing may include H/H, ferritin and TSAT levels.11,17 Common treatments involve erythropoietin, iron supplementation, blood transfusions, and vitamin B12 and folate supplementation.11

Acute

Chronic

Tachycardia

Asymptomatic

Palpitations

Fatigue

Angina

Weakness

Hypotension

Headache

Other Anemias Another form of anemia is anemia of chronic disease.

Also called “anemia of inflammation”, this disorder is due to conditions such as rheumatoid arthritis, lupus, cancer, HIV, and inflammatory bowel disease.27 When severe, this type of anemia resembles iron deficiency anemia.27 Symptoms are general, see Table 1.2 for a list. Suspected cases of this type of anemia are generally confirmed by detection of an increased level of cytokines. Other lab values include decreased MCV and TIBC, increased TSAT, and normal/elevated serum iron and ferritin.17,27 Treatment options for anemia of chronic disease include blood transfusions, erythropoietic agents, and iron therapy if deficiency is present.27 There are several other types of anemia which are less common. Two examples of these are sickle cell anemia and myeloplastic anemia which will not be discussed in the article.

Light-headedness

Sensitivity to cold

Shortness of breath

Pale and yellow skin

"Whooshing" sound in ears Table 1.2. General signs and symptoms of anemia.

CBC Hgb

Iron Studies M: 14-17 g/dL

RBC Indices

Serum Iron

M: 46-160 mcg/dL

F: 12-15 g/dL Hct

M: 42-50% F: 36-45%

RBC count

M: 4.5-6 x 106 cell/mL F: 4-5 x 10 cell/mL

Pharmacist’s Role The pharmacist has a critical role in the treatment of patients with anemia. Pharmacists can assist patients with therapy management, particularly in areas of iron administration, dietary recommendations, drug interactions with oral iron, and medications that can exacerbate conditions.

As pharmacists, we should also be aware of the signs and symptoms of anemia in order to assess efficacy of treatment and refer those patients who need to seek medical attention. Pharmacists can utilize their extensive pharmacological knowledge to increase positive outcomes in our patients.

Other

MCV

80-100 fL/cell

Vitamin B12

180-660 pg/mL

F: 30-160 mcg/dL Serum Ferritin

12-300 ng/mL

MCH

27-33 pg/cell

Plasma Folate

3.4-12.4 mcg/L

TIBC

220-420 mcg/dL

MCHC

33.435.5%

Reticulocyte count

M: 0.5-1.5%

TSAT

30-50%

F: 0.5-2.5%

6

RBC distribution width

14.5-15.5%

Schilling test (intrinsic factor)

10% excretion of radiolabeled B12

Methylmalonic acid

0.08-0.56 mcmol/L

Homocysteine

4-17 mcmol/L

Table 1.3. Common anemia laboratory parameters and normal ranges.

CBC=complete blood count Hgb=hemoglobin Hct=hematocrit RBC=red blood cell M=male F=female TIBC=total iron binding capacity TSAT=transferritin saturation MCV=mean cell volume MCH=mean cell hemoglobin MCHC=mean cell hemoglobin concentration

Iron Deficiency Vitamin B12 Deficiency

Folate Deficiency

Sore mouth

Numbness/parasthesia

Irritability

Smooth tongue

Imbalance (gait disturbance)

Personality changes

Pica

Personality changes

Depression

Pagophagia

Swollen/inflamed tongue

Memory impairment

Reduced saliva

Depression

Mouth sores

Table 2.1. Signs and symptoms for specific types of anemia.

Chronic Conditions

Drug-induced

Miscellaneous

Crohn's Disease

Aspirin

Folic acid deficiency

Ulcerative colitis

NSAIDS

Vitamin B12 deficiency

Rheumatoid Arthritis

PPIs

Pregnancy

Autoimmune disorders

H2RAs

Lactation

Cancer

Antacids

Heavy menstruation

Liver disease

Trimethoprim

Reduced stomach acid

Thyroid disease

Triamterene

Poor diet

Chronic Kidney Disease

Methotrexate

Malnutrition

Dialysis

Phenytoin

Infection

Alcoholism

Sulfasalazine

Children

Agent

Percent Elemental Iron

Elemental Iron/Dose Form

Ferrous gluconate

12%

39 mg/325 mg tablet

Ferrous sulfate

20%

37 mg/300 mg tablet 65 mg/325 mg tablet 60 mg/300 mg tablet 44 mg/5 mL elixir

Decrease iron absorption

Medications affected by iron

Gastric acid suppressants

Levodopa/methyldopa

(antacids, PPIs) Ferrous fumarate

33%

33 mg/100 mg tablet

Levothyroxine Cholestyramine

Polysaccharide-iron complex

100%

150 mg/capsule 50 mg/tablet

Bisphosphonates Tetracycline/doxycycline Fluoroquinolones

Table 2.2. Oral iron products.

Table 1.1. Risk factors for anemia.

PPIs=proton pump inhibitors H2RAs=histamine 2 receptor antagonists

Tetracycline/doxycycline Table 2.3. Drug-drug interaction with oral iron products.

PPIs=proton pump inhibitors

CONTINUING EDUCATION

Anemia Agent

Recommended Dosing

Iron sucrose

Non-dialysis: 200 mg administered on 5 different occasions within 14 days totaling 1000 mg in 14 days

Iron dextran

Dose (mL) = 0.0442 (desired Hgb - observed Hgb) x LBW + (0.26 x LBW), with desired hemoglobin at 14.8 g/dL and LBW= lean body weight; test dose of 0.5 ml should be given

Sodium ferric gluconate

125 mg elemental iron per dialysis session. Most patients will require a cumulative dose of 1 g elemental iron over approximately 8 sequential dialysis treatments to achieve a favorable response

Ferric carboxymaltose

<50 kg: 15 mg/kg elemental iron on day 1; repeat dose after at least 7 days (maximum: 1500 mg elemental iron per course). May repeat course of therapy if anemia reoccurs ≥50 kg: 750 mg on day 1; repeat dose after at least 7 days (maximum: 1500 mg per course). May repeat course if anemia reoccurs

Agent

Dosing

Adverse Drug Reactions

Oral B12

1000-2000 mcg/day

IM B12 injections

Start with 8-10 loading

Nausea, nervousness, dizziness, headache, edema, itching, diarrhea, rhinitis, dysnpea, peripheral vascular thrombosis, avoid if allergic to cyancobalamin or cobalt

Vitamin B12:

doses of 1000 mcg several times 1 week (if severe), taper to 1000 mcg /month Table 3.1. Recommended dosing for vitamin B12.

IM=intramuscular

Table 2.4. Parenteral iron products.

Agent

Dosing

Adverse Drug Reactions

Folic acid

Adults: 0.4 mg/day

(PO, IV, IM, SQ)

Pregnancy: 0.8/day

Malaise, flushing, rash, erythema, bronchospasm

Folate:

References 1. World Health Organization. Worldwide prevalence of anaemia 19932005. WHO, 2008.

2. American Society of Hematology. Anemia. Education in blood disorders for patients. Retrieved at: http://www.hematology.org/Patients/ Anemia/. Accessed 2014 Jul 5.

3. Little DR. Ambulatory management of common forms of anemia.

Am Fam Physician. 1999;59(6):1598-604.

4. National Institute of Health. What are the signs and symptoms of iron deficiency anemia? National Heart, Lung and Blood Institute. Retrieved at: http://www.nhlbi.nih.gov/health/health-topics/topics/ida/ signs.html#. Accessed 2014 Jul 7.

5. Merck manuals. Home health handbook. Overview of anemia.

Retrieved at: http://www.merckmanuals.com/home/blood_disorders/ anemia/overview_of_anemia.html. Accessed 2014 Jul 7.

6. Goddard AF, James MW, McIntyre AS et al. Guidelines for the management of iron deficiency anaemia. Gut. 2011;60:1309-1316.

7. Clark S. Iron deficiency anemia: Diagnosis and management. Curr Opin in Gastroenterol. 2009;25:122-8.

8. Snow CF. Laboratory diagnosis of vitamin B12 and folate deficiency.

Arc Intern Med. 1999;159:1289-1298.

9. Rumsey SE, Hokin B, Magin PJ, Pond D. Macrocytosis--an Australian general practice perspective. Aust Fam Physician. 2007 Jul;36(7):571-2.

10. Kaferle J, Strzoda CE. Evaluation of macrocytosis. Am Fam Physician. 2009;79(3):203-208.

11. National Kidney and Neurologic Diseases Information Clearinghouse. Kidney and urologic diseases A-Z list of topics and titles. Anemia in chronic kidney disease. Retrieved at: http://kidney.niddk.nih.gov/ kudiseases/pubs/anemia/#sec5. Accessed 2014 Aug 7.

12. Mayo Clinic. Diseases and conditions. Aplastic anemia. Retrieved at: http://www.mayoclinic.org/diseases-conditions/aplastic-anemia/ basics/definition/con-20019296. Accessed 2014 Aug 7.

13. Ferrous fumarate [monograph]. In: Lexicomp Online [online database]. Hudson, OH: Lexi-Comp.

Accessed 2014 Jul 12.

14. Ferrous sulfate [monograph]. In: Lexicomp Online [online database]. Hudson, OH: Lexi-Comp. Accessed 2014 Jul 12.

15. Ferrous gluconate [monograph]. In: Lexicomp Online [online database]. Hudson, OH: Lexi-Comp. Accessed 2014 Jul 12.

16. Polysaccharide-iron complex [monograph]. In: Lexicomp Online [online database]. Hudson, OH: Lexi-Comp. Accessed 2014 Jul 16.

17. Dipiro JT, Talbert RL, Yee GC et al. Pharmacotherapy: A pathophysiologic approach. 8th ed. China: McGraw-Hill. 2011. Retrieved at: http://accesspharmacy.mhmedical.com/content.aspx?bookid=462&Sectionid=41100892. Accessed 2014 Aug 11.

CONTINUING EDUCATION

Table 3.2. Recommended dosing for folate.

PO=oral IV=intravenous IM=intramuscular SQ=subcutaneous

18. Iron dextran complex [monograph]. In: Lexicomp Online [online database]. Hudson, OH: Lexi-Comp. Accessed 2014 Jul 12.

19. Iron sucrose [monograph]. In: Lexicomp Online [online database]. Hudson, OH: Lexi-Comp. Accessed 2014 Jul 12.

20. Ferric gluconate [monograph]. In: Lexicomp Online [online database]. Hudson, OH: Lexi-Comp. Accessed 2014 Jul 12.

21. Ferric carboxymaltose [monograph]. In: Lexicomp Online [online database]. Hudson, OH: Lexi-Comp. Accessed 2014 Jul 12.

22. Stabler SP. Clinical practice. Vitamin B12 deficiency. N Engl J Med. 2013 Jan 10;368(2):149-60.

23. Skerrett PJ. Vitamin B12 deficiency can be sneaky, harmful. Harvard Health Publications. 2013 Jan 10. Retrieve dat www.health.harvard.edu/blog/vitamin-b12-deficiency-can-be-sneaky-harmful-201301105780. Accessed 2014 Juyl 8.

24. Oh R, Brown D. Vitamin B12 deficiency. Am Fam Physician. 2003;67:979-86.

25. Cyanocobalamin [monograph]. In: Lexicomp Online [online database]. Hudson, OH: Lexi-Comp. Accessed 2014 Aug 7.

26. Folic acid [monograph]. In: Lexicomp Online [online database]. Hudson, OH: Lexi-Comp. Accessed 2014 Aug 7.

27. Weiss G & Goodnough LT. Anemia of chronic disease.

N Engl J Med 2005;352:1011-23

ACPE UAN# 0100-0000-14-069-H01-P 0100-0000-14-069-H01-T

Winter 2014 • Arizona Journal of Pharmacy • 35

A Review of Common Drug-drug and Food-drug Interactions Associated with Cardiovascular Medications

By Raymond Kho, Pharm.D. Candidate, Sarah Kim, Pharm.D. Candidate, Stacy Lee, Pharm.D. Candidate, and Laura Tsu, Pharm.D., BCPS, Midwestern University College of Pharmacy - Glendale Goal: This home-study CPE activity has been developed to educate pharmacists on the common drug-drug and food-drug interactions associated with cardiovascular medications.

Objectives 1. Identify the uses of various over-the-counter (OTC) products of interest in cardiovascular patients 2. Describe the mechanism of action (MOA) of various fooddrug/drug-drug interactions involving cardiovascular medications (statins, antiplatelet therapies, warfarin, red yeast rice) 3. Explain the clinical significance of these interactions in medication therapy 4. Relate recommendations with current clinical evidence 5. Formulate an appropriate treatment plan given a possible drug interaction scenario for cardiovascular patients Clopidogrel and PPIs Clopidogrel (Plavix速) is an antiplatelet medication used to lower the risk of ischemic events in patients who suffer from coronary artery disease (CAD), peripheral artery disease (PAD), or who have undergone percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG). As a hepatically activated prodrug, it must first be metabolized via CYP2C19 before it can take effect.1 Once activated, clopidogrel prevents the activation of platelets by inhibiting adenosine diphosphate (ADP) receptors, specifically P2Y12 receptors, on the platelet surface.2 ADP is an endogenous prothrombic molecule that is crucial for the initiation of clot formation. As shown in the Clopidogrel in High-Risk Patients with Acute Nondisabling Cerebrovascular Events (CHANCE) trial, clopidogrel with aspirin in dual-antiplatelet therapy has shown added benefits in the prevention of ischemic events in patients who suffered recent transient ischemic attack (TIA) or minor stroke, compared to these medications alone.3 The Clopidogrel for the Reduction of Events During Observation (CREDO) trial found an increase in thromboembolic protection with dual-antiplatelet therapy in patients who had recently undergone PCI.4 Studies have also shown a trend toward fewer ischemic strokes and heart failure in those with non-ST elevation acute coronary syndrome taking dual-antiplatelet therapy, as well as a decreased occurrence of stent thrombosis compared to warfarin-aspirin therapy.5,6 Interaction Due to the inherent bleeding concerns that accompany the use of antiplatelet drugs and aspirin, there is legitimate controversy over the concomitant use of these agents. Studies have shown that there may be an increased risk of gastrointestinal (GI) bleeding associated with clopidogrel-aspirin dual therapy and CONTINUING EDUCATION

that proton-pump inhibitors (PPI) may be beneficial in reducing these events.7 PPIs are known inhibitors of CYP2C19 with differing degrees of inhibition attributed to each PPI; therefore, new concerns arise regarding PPIs decreasing the conversion of clopidogrel to its active form and the subsequent increased risk of thromboembolic events. Recent studies have been performed to more clearly elucidate the risk versus benefit of concomitant use of PPIs in patients undergoing clopidogrel-aspirin therapy, which have important implications for pharmacists who may encounter this regimen in practice.

There are studies that suggest PPIs like omeprazole may have an effect on the activation of clopidogrel8 and lead to increased platelet reactivity in patients who are at risk for clots. These findings are supported by studies that have shown that patients using PPIs with clopidogrel suffer worse outcomes9,10 versus those not using PPIs or PPIs that are only slightly metabolized by CYP2C19, like pantoprazole. From these studies, it was believed that alternatives for CYP2C19-metabolized PPIs, such as histamine-2-receptor antagonists or differently metabolized PPIs would provide more benefit to patients on clopidogrel-aspirin therapy.

However, conflicting research suggests that the pharmacodynamic interactions observed between PPIs and clopidogrel are not universal among PPIs and are mostly limited to omeprazole.11,12 This is supported by the Clopidogrel and the Optimization of Gastrointestinal Events Trial (COGENT), a randomized controlled trial that sought to investigate the efficacy and safety of clopidogrel with PPIs in patients receiving aspirin. Bhatt et al. found that PPI use significantly reduced bleeding risks in these patients and concluded that the use of omeprazole and clopidogrel did not result in clinically significant cardiovascular interactions7. Recent retrospective observational reviews also paint a contradictory picture. In their analysis, Dunn et al. found that PPI-use in the CAPRIE study correlated with reduced effects of clopidogrel, at least in patients who were not also receiving aspirin, while data from the CREDO trial showed no increase in cardiovascular events in the PPI group.13 Currently, there is no consensus regarding the effect PPI-use has on outcomes in patients on dual-antiplatelet therapy and further studies are needed to more clearly

Food-Drug Interactions understand their relationship.

Recommendation In 2010, the American College of Cardiology Foundation (ACCF), American College of Gastroenterology (ACG), and American Heart Association (AHA) issued a consensus document to address the controversy regarding PPIs and drugs like clopidogrel. The document acknowledged the pharmacokinetic plausibility of a drug-drug interaction involving CYP2C19 and the need for further research into its clinical significance. For healthcare professionals, these organizations suggest careful discretion for patients on GI prophylaxis and antiplatelet therapies. Although PPIs are considered appropriate in patients undergoing antiplatelet therapy, the risks and benefits associated with cardiovascular (CV) and GI complications must be considered as well.14 Risk factors for GI bleed such as history of GI bleed, advanced age, and use of corticosteroids must be assessed, and PPI use should be reserved for those who are at highest risk. A patient’s physician should be consulted if concerns of negative CV outcomes outweigh the risk of developing a GI bleed.

Niacin Nicotinic acid (niacin) is recommended as a therapeutic option for the treatment of dyslipidemia due to its effectiveness in favorably affecting all lipid parameters: it increases high density lipoprotein (HDL) cholesterol by 15-35%, decreases low density lipoprotein (LDL) cholesterol by 5-25%, and additionally decreases triglycerides (TGs) by 20-50% with doses of 2-3 g/day.15 It is thought that niacin achieves this by working on multiple tissues, proteins, and enzymes.16 In the liver, niacin has three functions: decrease TG synthesis to ultimately decrease very low density lipoproteins (VLDL) and LDL secretion, inhibit removal of HDL from circulation, and increase HDL biogenesis. Lipid-independent effects include decreased monocyte adhesion and infiltration, increased HDL function, and decreased foam cell formation.These effects, however, have not been conclusively shown to translate into improved clinical outcomes in clinical trials.17, 18 In particular, the recent HPS2-THRIVE randomized-controlled trial confirmed the results of the AIM-HIGH trial, demonstrating no additional benefit of adding extended release (ER) niacin and laropiprant (to decrease flushing) to first-line therapy.19 Newly released hyperlipidemia guidelines include this information and recognize that lowering non-HDL-C when LDL-C is at target levels yields no additional benefit in reducing arteriosclerotic cardiovascular disease (ASCVD) events.20 These new guidelines focus on statin therapy, finding no data supporting the efficacy of adjunct non-statin agents in reducing ASCVD events. Adjunct therapy with agents shown to reduce ASCVD risk in RCTs is only recommended for high-risk individuals who have insufficient response to statins, who cannot tolerate recommended higher statin doses, or canCONTINUING EDUCATION

not tolerate statins at all. Given the results of the HPS2THRIVE and AIM-HIGH trials, niacin may not qualify as a non-statin alternative under these new guidelines.

Interaction Some of niacin’s side effects stem from how its different formulations are metabolized by the liver with first-pass metabolism.21 Niacin is metabolized by two pathways that result in either conjugation or amidation. The conjugative pathway, a low-affinity and high-capacity pathway, is only utilized when the amidation pathway (high-affinity and low-capacity) is saturated. It is these glycine conjugated products, such as nicotinuric acid, that lead to prostaglandin-mediated vasodilation and flushing. Tolerance to flushing may develop but not before many discontinue therapy due to the discomfort.

The high-affinity and low-capacity amidation pathway generates nicotinamide and pyrimidine metabolites that are associated with hepatotoxicity. Hepatotoxicity caused by niacin has been described to have an onset of 1 week to 48 months.22 This usually presents with elevated aminotransferase levels, but there are mixed reports of patterns of hepatocellular and cholestatic injury. Other effects include nausea and vomiting and a sharp decrease in serum lipid levels, which is reversible, with a recovery period of 1-2 months following discontinuation. Although fulminant hepatic failure is rare, hepatotoxicity is a concern with doses exceeding 2-3 g/ day.

Niacin is available in many formulations: immediate-release (IR), extended-release (ER) and sustained-release (SR). Most formulations are available as OTC supplements that have not been reviewed by the FDA for safety and efficacy as agents for dyslipidemia, with only a few that have FDA approval.23 Since IR products will quickly saturate the amidation pathway, most of the IR dose will be metabolized by the conjugative pathway such that the primary side effect will be flushing. In contrast, SR products slowly release niacin over time which is continuously metabolized by the amidation pathway, resulting in increased risk of hepatotoxicity. Thus, IR use is limited by extreme flushing while SR use is limited by risk of hepatoxicity. Patients who take IR niacin products at therapeutic doses almost never experience hepatotoxicity, but half of those who take SR niacin will have elevated transaminases. Niaspan®, the only available ER product, seems to be equally metabolized by the two pathways such that it has relatively moderate levels of flushing and hepatotoxicity.

In a clinical trial, only 5% of patients stopped therapy due to flushing and it has not been shown to cause an increase in aminotransferase levels at doses of 2 g/day or lower. This middle-of-the-road product is preferable, but currently, it is only available prescription-only.

Winter 2014 • Arizona Journal of Pharmacy • 37

Food-Drug Interactions Recommendation Due to the wide availability and range of niacin products on the market, any patient taking these products should be advised about the side effects specific to the formulation that they are taking. Patients might readily purchase OTC niacin products without knowledge of the risks of flushing and hepatoxicity. Given the moderate side effect profile of NiaspanÂŽ, it would be the preferred niacin product; however, there may be an associated increase in cost. In addition to flushing and hepatotoxicity, niacin is known to cause hyperglycemia so caution must also be taken with diabetic patients. Pharmacists and physicians should monitor for these side effects and start with lower doses. With the recent results from clinical trials and hyperlipidemia guidelines, it is even debatable whether adding niacin is beneficial for decreasing clinical outcomes in patients with dyslipidemia.

Fish Oil and Warfarin Therapy with fish oil supplements is indicated for those with CAD and high-dose fish oil supplements are indicated for use in hypertriglyceridemia (AHA). Fish oils contain the omega-3 fatty acids eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), which have potent anti-inflammatory effects stemming from their ability to inhibit cyclooxygenase, an essential enzyme required for the formation of prostaglandins and thromboxane.24 Reducing inflammation, coupled with the inhibition of pro-atherosclerotic mediators25, likely account for EPA and DHAâ&#x20AC;&#x2122;s potent plaque stabilization characteristics. These fatty acids are also believed to reduce triglyceride levels through numerous mechanisms including the modulation of nuclear transcription factors associated with lipogenesis.26 Studies are underway to further elaborate on the benefits of omega-3 fatty acids on other conditions including rheumatoid arthritis, hypertension and depression.

Interaction A study by Shahar et al. regarding atherosclerosis risk and omega-3 fatty acids showed that fish oils may decrease fibrinogen, factor VIII, and Von Willebrand factor (vWF), as well as increase protein C.27 Fish oilâ&#x20AC;&#x2122;s possible interaction with platelets and clotting factors raises concern over their potential to increase bleeding risk in patients. This concern is further compounded when fish oils are taken by patients who are already on antiplatelets or anticoagulants, as this may lead to severe bleeding events. In addition to the additive anti-atherothrombic actions of fish oils with warfarin, EPA and DHA may cause increased bleeding due to interactions that result in decreased platelet aggregation28, decreased platelet derived growth factor-like proteins29, and decreased platelet activating factor.30 In fact, increases in baseline INR have been reported in patients who have significantly increased their CONTINUING EDUCATION

doses of fish oil to ~2g/day while taking warfarin.31 One randomized-controlled trial that included 610 subjects showed no difference in bleeding in patients using high-dose (4g) fish oil therapy versus control.32 The study also found no increase in bleeding time between the two groups, though it did acknowledge that investigation of larger doses may be warranted. The researchers also measured plasma beta-thromboglobulin levels among the participants, which increases with platelet activation, and found no difference between the study and control groups. Another randomized-controlled trial, which included patients on chronic warfarin therapy, showed no difference in lead-in INR and treatment INR among study groups.33 As the participants were stratified into groups that received placebo, 3g fish oil, or 6g fish oil, no differences in INR were noted among the different groups. In this study, Bender et al. conclude that fish oil supplementation of up to 3-6g/day does not significantly affect the safety of patients taking warfarin.

Recommendation In spite of these studies, there is not enough definitive evidence that validates the relationship between the use of fish oils and increased bleeding time. So how are healthcare professionals to respond when faced with patients taking fish oil supplements along with their antithrombic therapy? One proposed approach is to follow the guidelines that are applicable to other anticoagulants.34 This entails the reduction of fish oil consumption or discontinuation of fish oils supplementations when the patient is suffering from acute bleeding illnesses like hemorrhagic stroke. Also, the discontinuation of fish oils before surgical procedures (to decrease the risk of bleeding) and restarting these therapies following major operations (for its antithrombotic effects) should be considered. For all cases, it is the duty of healthcare professionals to weigh the risks and benefits of fish oils in patients who are at increased risk for bleeding complications.

Red Yeast Rice Red yeast rice (RYR) has been consumed for thousands of years since its use as a food spice in Asia. It is prepared by fermenting rice with the mold Monascus purpureus (M. purpureus) under sterile and controlled conditions.

The ultimate product contains starch, sugar, sterols, isoflavones, pigments, fatty acids and, most notably, yeast polyketides.35 These polyketides consist of monacolins that include monacolin K, a compound that is identical in structure to lovastatin, an HMG-CoA reductase inhibitor; hence there was a controversy over its status as an OTC product, since it contains an FDA regulated drug.

In May 1998, the FDA took the stance that RYR supplements containing lovastatin are unapproved drugs.36 This

Food-Drug Interactions was upheld by several courts and the FDA began enforcing this edict. Currently, labels of RYR products do not contain information on levels of lovastatin and many do not contain lovastatin at all. Those that do are considered illegal, as emphasized by a consumer warning issued in 2007.37 The clinical efficacy of RYR products containing lovastatin has been demonstrated by several groups.38 In addition to reducing total cholesterol and LDL levels, it decreases the frequency of major coronary events. Studies have found that RYR products containing 2-5 mg of lovastatin have similar efficacy to 20 mg of lovastatin.39 This suggests that there are additive and/or synergistic effects of the various components of RYR such as isoflavonoids, monounsaturated fats, and sterols.38 There is no specified role for RYR in updated hyperlipidemia guidelines,20 and it is briefly mentioned as alternative or adjunct therapy in ESC/EAS guidelines.40 Sales of RYR increased 80% between 2005 and 2008 to $20 million,36 making it vitally important for pharmacists to be aware of its uses and limitations.

Interaction Since RYR is defined as a dietary supplement, it is regulated

by Current Good Manufacturing Practices (cCGMP) published by the FDA.37 These regulations not only require that companies produce products that are consistent, but also that they are not adulterated and correctly labeled. A few studies validating the contents of RYR products have been performed.

The first study conducted in 2001, analyzed nine proprietary Chinese RYR dietary supplements.41 The amount of total monacolin K ranged widely from 0.15 to 3.37 mg/capsule. Moreover, they found citrinin, a compound that causes kidney failure in animals and genotoxic in cultured human lymphocytes at high doses, in seven of the nine samples.

In 2010, Gordon et al. examined these and other indices of product purity.36 Similar to previous findings, there was a wide variability in ingredients among the different products: total monocolins ranged from 0.31 to 11.15 mg/capsule, monocolin K was 0.10 to 10.09 mg/capsule, and monocolin KA was 0.00 to 2.30 mg/capsule. Put in terms of total daily dose following serving recommendations, this would be a range of 2.71 to 24.71 total monacolins. Four products had elevated levels of citrinin. The authors of the most recent study directly contacted the FDA regarding RYR oversight.37 The FDA admitted to having no information on the number of RYR manufacturers or distributors, and also reported that they are not able to ensure whether these products are consistent with cGMP regulations. These researchers did not quantify the active ingredients in the products, but rather looked at their labeling. They found that only 43 of 70 products had statin-related warnings, and none of the 101 products had been confirmed to pass a verification test (i.e.

USP, Consumer Labs, NSF, or NPA). Moreover, several were combination products with other lipid-lowering agents (e.g.

CONTINUING EDUCATION

coenzyme-Q10, niacin and fish oil), vitamins (e.g. folic acid, vitamin B6, and vitamin B12), and dietary supplements.

In addition to the wide variability of ingredients in RYR products, there are many safety monitoring parameters that need to be considered. Relative to lovastatin, RYR extracts were found to inhibit all six CYP450 enzymes tested (CYP2B6, 2C9, 2C19, 3A4, 1A2 and 2D6) and P-glycoprotein (P-gp) to a greater extent,39 so drug-drug interactions should be assessed.

Although most trials have found RYR to be well-tolerated, cases of myopathy, rhabdomyolysis, hepatotoxicity, and anaphylaxis have also been reported.38, 40 Furthermore, it is considered a pregnancy category X with documented fetal abnormalities and should be taken with caution in patients with renal/hepatic impairment. Lastly, since it is a yeast product, it should not be taken if the patient is allergic to yeast products.

Recommendations As with all supplements, great care should be taken in helping a patient select a RYR, especially given that there are numerous discrepancies and variability in content. Despite the FDA’s prohibition on lovastatin-containing RYR products, they have done little to actually regulate and enforce this. Thus, pharmacists must be able to counsel patients inquiring about RYR, especially about its safety concerns. Quantity and quality may vary not only from manufacturer to manufacturer, but from batch to batch or even bottle to bottle as well. Patients should be cautioned against its use despite its proven efficacy, due to safety concerns of consuming unknown amounts of a FDA approved drug with known drug-drug interactions and side effects. If patients have untreated dyslipidemia and are self-medicating with RYR, they may be directed to other OTC products or supplements that do not contain an active drug ingredient. They should also be advised on non-pharmacological treatment options like lifestyle changes. The best thing an individual could do is speak with their physician about a cost-effective FDA regulated pharmacological therapy option, with monitoring for safety and counseling on its use.

St. John’s Wort and Statins St. John’s wort (Hypericum perforatum) is an OTC herbal supplement that is widely used in the U.S., and stands as the second best-selling herbal medicine product in the nation.43 Although a meta-analysis of 29 trials concluded that St. John’s wort extract was superior in treating depression versus placebo44, multiple randomized controlled trials have failed to show its efficacy as a treatment for depression.45,46 The current American Psychiatric Association’s guidelines Winter 2014 • Arizona Journal of Pharmacy • 39

Food-Drug Interactions for treating major depressive disorder states that St. John’s wort is not recommended for use in treating depression, due to the lack of evidence and regulation.47 However, St. John’s wort is still commonly being used by the U.S. population as an OTC self-treatment agent for depression.

St. John’s wort contains an array of compounds that may contribute to its potential pharmacological activities, including two compounds: hyperforin and hypericin.48 In particular, hyperforin has been identified as an inhibitor of several neurotransmitters including serotonin, norepinephrine, and dopamine.49 However, St. John’s wort also presents with it an increased risk of drug-drug interactions due to the enzyme-inducing properties associated with its natural compounds.50 Such activity may decrease the serum drug levels of medications, thereby jeopardizing the therapeutic efficacy of many prescription medications. One possible interaction with St. John’s wort that has been identified in trials is associated with HMG-CoA reductase inhibitors, also known as statins. As statins are one of the most dispensed prescription medications in the U.S.51, the prevalence of a drug interaction with popular natural products like St. John’s wort is highly likely. In order to ensure the efficacy of treatment in patients with hyperlipidemia, an assessment for possible drug interactions is warranted in individuals who are taking statin medications.

Interaction St. John’s wort is an inducer of both CYP3A4 and P-gp, which are involved in the metabolism of many drugs in the human body.52,53 This induction may be explained by St. Johns wort’s role as a ligand for the nuclear pregnane X receptor (PXR).

Activation of the PXR increases the expression of both P-gp and CYP3A4, so increased levels of St. John’s wort induces the expression of P-gp and CYP3A4 in the human body.54 Another source of interaction is the natural compound hyperforin, which has been identified as an inducer of CYP3A455, an enzyme that is responsible for metabolizing about 50% of all prescription medications on the market.50 Atorvastatin, simvastatin, and lovastatin have been identified as CYP3A4 substrates56, while atorvastatin and simvastatin are also substrates of P-gp.57 Therefore, the concomitant use of St. John’s wort with these statin medications leads to an increase in statin metabolism, resulting in diminished efficacy. Several studies have demonstrated the effect of this drug interaction. (Table 1) One randomized, double-blind study showed that taking St. John’s wort for 2 weeks prior to taking simvastatin resulted in a statistically significant decrease in the serum concentration and the AUC of active simvastatin metabolite.58 Another randomized-controlled trial tested the significance of this interaction in 16 patients with hypercholesterolemia who were being treated with a stable dose of atorvastatin. When atorvastatin was taken daily with St. John’s wort, statistically significant increases were observed in both the serum LDL and total cholesterol levels, representing a decreased efficacy CONTINUING EDUCATION

of clinical importance.53 Another study featured 24 patients with hypercholesterolemia who were being treated with a stable dose of simvastatin. Similar to a previous study, concomitant use resulted in significantly increased levels of serum LDL and total cholesterol.59 Table 1. St. John's wort and its effect on antihyperlipidemic therapy Sugimoto et al.58 Andren et al.53 16 healthy 16 patients with Demographics volunteers hypercholesterolemia Simvastatin Atorvastatin Statin 10mg x1 on day 14 10mg-40mg* daily Dose/frequency 300mg BID SwJ dose/frequency 300mg TID 14 days 4 weeks Duration Decreased serum Increased LDL Effect simvastatin active (p=0.004) metabolite Increased total Decreased AUC cholesterol (p=0.02) (metabolite)

Eggertsen et al.59 24 patients with hypercholesterolemia Simvastatin 10-40mg* daily 300mg BID 4 weeks Increased LDL (p<0.0001) Increased total cholesterol (p<0.0001) Increased triglycerides in females (p=0.036) *Indicates the stable dose of medication each patient was originally being treated with.

The increased levels of LDL and total cholesterol demonstrated in these studies have a direct influence on the clinical outcomes of patients who are on statin medications. Excess LDL circulating in the blood can get oxidized and turn into foam cells, eventually turning into atherosclerotic plaques.60 Increased plasma concentration of oxidized LDL has also been associated with increased risk of chronic heart disease.61 The inadequate control of total cholesterol and LDL levels in hyperlipidemic patients using St. John’s wort and statins may lead to potentially life-threatening clinical outcomes associated with the increased risk of cardiovascular disease.

Recommendations St. John’s wort is a popular OTC supplement which is widely used as an alternative treatment option for depression. However, it poses risks of numerous drug-drug interactions as an inducer of many drug-metabolizing pathways in the human body. A pharmacist should educate patients about the lack of consistent evidence for the efficacy of St. John’s wort, and APA guideline recommendations against its use as a general treatment for treating depression.

Every patient who is on simvastatin, atorvastatin, or lovastatin must be screened for the use of St. John’s wort. When a concomitant use is identified, the patient must be educated about the potential drug interactions associated with this supplement, including the potential decrease in the control of hyperlipidemia. Because it is difficult to detect the diminished efficacy of statin medication in a short-term period, it is important for patients to be aware of this interaction. The patient should also be encouraged to engage in an active conversation with the physician about the efficacy of the statin treatment, with a possible in-

Food-Drug Interactions crease in the dose of the statin medication or the initiation of a new antidepressant.

Grapefruit Juice and Statins While the concomitant use of two different drugs can result in adverse events due to drug-drug interactions, consuming certain food products while taking a medication can also influence the pharmacokinetics of drugs and ultimately affect the clinical efficacy of the medication.

Grapefruit juice is a product that has numerous food-drug interactions, including calcium channel blockers, CNS modulators, and statins. Although no single constituent has been identified as the cause of these interactions, grapefruit juice contains many naturally-occurring compounds such as flavonoids and furanocoumarins which have been found to have inhibitory effects on CYP3A4 and P-gp.56 The concurrent intake of statins with substances that inhibit metabolic enzymes has been shown to increase statin serum concentration levels, which may increase the risk of undesirable side effects such as rhabomyolysis or renal failure.

According to the new 2013 ACC/AHA guidelines, statins are recommended as the primary pharmaceutical therapy for treatment of blood cholesterol to reduce the risk of ASCVD.20 The Centers for Disease Control and Prevention’s report on prescription drug use revealed that the use of antihyperlipidemic medications in the U.S. doubled between 1999 and 2010.62 The trend in increased use of statins is most likely to continue since the new ACC/ AHA guidelines greatly expanded the criteria for statin use. As grapefruit juice and grapefruit are common foods that are widely consumed by the public, assessment for possible food-drug interactions is warranted for patients who are taking statin medications.

Interaction Several statin medications such as atorvastatin, lovastatin, and simvastatin are metabolized through the CYP3A4 enzyme.56 This predisposes patients that use these medications to possible drug interactions when used concomitantly with agents that inhibit or induce CYP3A4.

Pravastatin, fluvastatin, pitavastatin and rosuvastatin have been shown to be metabolized by CYP3A4 at a lesser degree63, decreasing the possible risk for interactions with substances that affect CYP3A4. As demonstrated by several randomized controlled studies, grapefruit juice is one such substance that inhibits CYP3A4 in the small intestine64 and increases the plasma concentration of statins with concomitant use. (Table 2) The daily consumption of double-strength grapefruit juice prior to initiating statin medications has been shown to produce a statistically significant increase in the area under the plasma concentration-time curve (AUC) and the peak serum concentration (Cmax) of simvastatin, CONTINUING EDUCATION

atorvastatin, and their active metabolites.65,66,67 Similar results occurred in studies that used regular strength grapefruit juice.68,69 However, trials that demonstrated increased serum statin levels were mostly conducted with healthy, male volunteers and not patients who were already taking statin medications for hyperlipidemia. (Table 2) Therefore, the data is not representative of the actual population of patients who are at risk of potential adverse events associated with prolonged statin use.

Table 2. Effect of grapefruit juice consumption on serum statin concentration

Demographi cs Statin Dose gFJ dose/freq Duration Effect

Lilja et al.67

kantola et al.65

Lilja et al.66

10 healthy voluntee rs Lovastati n 80mg x1 on day 3 DS 200mL TID 3 days

10 12 healthy healthy volunteers volunteers

10 20 healthy healthy volunteers volunteers

8 healthy volunteers

Simvastat in 60mg x1 on day 3 DS 200mL TID 3 days Increased Cmax, AUC

Simvastat in 40mgX1 on day 3 RS 200 mL daily

Atorvastat in 10mg x1 on day 3 RS 250mL TID

Atorvastat in 20mg daily RS 250mL TID

3 days

3 days Increased AUC, Cmax (metabolit e)

4 days

Increase d Cmax, AUC

Atorvastatin 40mg x1 on day 3 DS 200mL TID 3days Increased AUC, Cmax(metaboli te)

Lilja et al.68

Increased Cmax, AUC

Fukazaw a et al.69

Ando et al.70

Increased AUC

While increased blood level of statins may possibly result in an increased risk of myopathy71, it is unclear whether a linear relationship exists between the changes in plasma concentration of statins and the risk of adverse events.72 Multiple variables influence the risk of such adverse events, such as the rapid change in drug concentration, use of other lipid-lowering therapy, and genetic factors.73 In fact, while one study utilizing daily doses of atorvastatin and grapefruit juice showed an increase in AUC of the drug, a wide variation in the AUC of atorvastatin was also present among the individuals in the control group that had consumed water instead of grapefruit juice.70 The polymorphisms in CYP enzymes and transporters may produce inherent differences in each individual’s ability to metabolize statins74 and may account for the varying response and efficacy of statins in different patients.

Nevertheless, an analysis of FDA Adverse Event reports show that about 55% of all statin-associated rhabdomyolysis are suspected to be the result of drug-drug interactions75 and multiple cases of rhabdomyolysis have been reported in patients who regularly consumed grapefruits or grapefruit juice while they were on statin medications.76,77,78 Although it is not possible to know the exact clinical consequence in each patient taking statins and grapefruit juice, there is a definite risk of potentially harmful interactions with the concomitant use.

Recommendations In order to ensure the safety of patients taking statin medications, each patient should be educated about the possible drug interactions of statins and the risk of potentially serious complications that could arise as a result of the interactions, such as rhabdomyolysis. Before Winter 2014 • Arizona Journal of Pharmacy • 41

Food-Drug Interactions dispensing the medication, a pharmacist should screen the patientâ&#x20AC;&#x2122;s profile for possible drug-drug interactions and talk to the patient about the possible risk of drug-food interactions.

For patients taking simvastatin, atorvastatin, or lovastatin, the pharmacist should ask the patient about grapefruit or grapefruit juice consumption, and educate the patient about the possible adverse events associated with this interaction.

In order to eliminate the risk of a possible adverse event, it may be advisable to discourage the concomitant use of these medications with grapefruit juice. Consuming large amounts of grapefruit juice (more than a quart per day) while on these medications should be discouraged in these patients.79 Statin medications that do not confer the risk of this interaction and thus could be considered as alternative treatment options include pravastatin, fluvastatin, and rosuvastatin.80 References

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28. Kim DN, Eastman A, Baker JE et al. Fish oils, atherogenesis, and thrombogenesis. Ann N Y Acad Sci. 1995; 748:474-80.

29. Kaminski WE, Jendraschak E, Kiefl R et al. Dietary omega-3 fatty acids lower levels of platelet-derived growth factor mRNA in human mononuclear cells. Blood. 1993; 81:1871-9.

30. Mayer K, Merfels M, Muhly-Reinholz M et al. Omega-3 fatty acids suppress monocyte adhesion to human endothelial cells: role of endothelial PAF generation. Am J Physio Heart Circ Physiol.

2002; 283:H811-8.

31. Buckley MS, Goff AD, Knapp WE. Fish oil interaction with warfarin. Ann Pharmacother. 2004; 38:50-3.

32. Eritsland J, Arnesen H, Seljeflot I et al. Long-term effects of n-3 polyunsaturated fatty acids on haemostatic variables and bleeding episodes in patients with coronary artery disease. Blood Coagul Fibrinolysis. 1995; 6:17-22 33. Bender NK, Kraynak MA, Chiquette E et al. Effects of marine fish oils on the anticoagulation status of patients receiving chronic warfarin therapy. J Thromb Thrombolysis. 1998; 5:257-61.

34. Bays HE. Safety considerations with omega-3 fatty acid therapy. Am J Cardiol. 2007; 99:35C-43C. 35. Fung WT, Subramaniam G, Lee J et al. Assessment of extracts from red yeast rice for herb-drug interaction by in-vitro and in-vivo assays. Sci Rep. 2012;2:298.

36. Gordon RY, Becker DJ. The role of red yeast rice for the physician. Curr Atheroscler Rep. 2011;13(1):73-80.

37. Childress L, Gay A, Zargar A et al. Review of red yeast rice content and current Food and Drug Administration oversight. J Clin Lipidol. 2013;7(2):117-22 38. Klimek M, Wang S, Ogunkanmi A. Safety and efficacy of red

Food-Drug Interactions yeast rice (Monascus purpureus) as an alternative therapy for hyperlipidemia. P T. 2009;34(6):313-27.

39. Chen CH, Uang YS et al. Interaction between Red Yeast Rice and CYP450 Enzymes/P-Glycoprotein and Its Implication for the clinical pharmacokinetics of lovastatin. Evid Based Complement Alternat Med.2012;2012:127043.

40. European Association for Cardiovascular Prevention & Rehabilitation, Reiner Z,Catapano AL, De Backer G et al. ESC/EAS Guidelines for the management of dyslipidaemias: the Task Force for the management of dyslipidaemias of the European Society of Cardiology (ESC) and the European Atherosclerosis Society (EAS). Eur Heart J. 2011;32(14):1769-818.

41. Heber D, Lembertas A, Lu QY et al. An analysis of nine proprietary Chinese red yeast rice dietary supplements: implications of variability in chemical profile and contents. J Altern Complement Med. 2001;7(2):133-9.

42. Gordon RY, Cooperman T, Obermeyer W et al. Marked variability of monacolin levels in commercial red yeast rice products: buyer beware!

Arch Intern Med. 2010;170(19):1722-7.

43. Ernst E. The risk-benefit profile of commonly used herbal therapies: Ginkgo, St. John’s Wort, Ginseng, Echinacea, Saw Palmetto, and Kava.

Ann Intern Med. 2002;136(1):42-53. Review.

44. Linde K, Berner MM, Kriston L. St John’s wort for major depression.

Cochrane Database Syst Rev. 2008; (4):CD000448.Review.

45. Shelton RC, Keller MB, Gelenberg A et al. Effectiveness of St John’s wort in major depression: a randomized controlled trial. JAMA. 2001;285(15):1978-86.

46. Hypericum Depression Trial Study Group. Effect of Hypericum perforatum (St John’s wort) in major depressive disorder: a randomized controlled trial. JAMA.2002;287(14):1807-14.

47. American Psychiatric Association. Practice Guideline for the Treatment of Patients With Major Depressive Disorder, Third Edition. http://psychiatryonline.org/content.aspx?bookid=28&sectionid=1667485#654006. (accessed 2014 Jan 20).

48. Bennett DA Jr, Phun L, Polk JF et al. Neuropharmacology of St. John’s Wort (Hypericum). Ann Pharmacother. 1998;32(11):1201-8. Review.

49. Müller WE, Singer A, Wonnemann M, et al. Hyperforin represents the neurotransmitter reuptake inhibiting constituent of hypericum extract. Pharmacopsychiatry. 1998;31 Suppl 1:16-21.

50. Markowitz JS, Donovan JL, DeVane CL et al.Effect of St John’s wort on drug metabolism by induction of cytochrome P450 3A4 enzyme.

JAMA. 2003;290(11):1500-4.

51. IMS Institute for Healthcare Informatics. The Use of Medicines in the United States: Review of 2010.http://www.imshealth.com/imshealth/Global/Content/IMS%20Institute/Documents/IHII_UseOfMed_ report%20.pdf. (accessed 2013 Jan 20).

52. Dürr D, Stieger B, Kullak-Ublick GA et al. St John’s wort induces intestinal P-glycoprotein/MDR1 and intestinal and hepatic CYP3A4. Clin Pharmacol Ther.2000; 68:598-604.

53. Andrén L, Andreasson A, Eggertsen R. Interaction between a commercially available St. John’s wort product (Movina) and atorvastatin in patients with hypercholesterolemia. Eur J Clin Pharmacol.

2007;63(10):913-6.

54. Kullak-Ublick GA, Becker MB. Regulation of drug and bile salt transporters in liver and intestine. Drug Metab Rev. 2003;35(4):305-17.

Review.

55. Moore LB, Goodwin B, Jones SA et al. St. John’s wort induces hepatic drug metabolism through activation of the pregnane X receptor. Proc Natl Acad Sci U S A. 2000;97:7500-7502.

56. Dahan A, Altman H. Food-drug interaction: grapefruit juice augments drug bioavailability--mechanism, extent and relevance. Eur J Clin Nutr. 2004;58(1):1-9. Review.

57. Zhou S, Chan E, Pan SQ et al. Pharmacokinetic interactions of drugs with St John’s wort. J Psychopharmacol. 2004;18(2):262-76. Review.

CONTINUING EDUCATION

58. Sugimoto K, Ohmori M, Tsuruoka S et al. Different effects of St John’s wort and the pharmacokinetics of simvastatin and pravastatin.

Clin Pharmacol Ther. 2001;70(6):518- 24.

59. Eggertsen R, Andreasson A, Andrén L. Effects of treatment with a commercially available St John’s Wort product (Movina) on cholesterol levels in patients with hypercholesterolemia treated with simvastatin.

Scand J Prim Health Care. 2007;25(3):154-9.

60. Iuliano L, Mauriello A, Sbarigia E et al. Radiolabeled native low-density lipoprotein injected into patients with carotid stenosis accumulates in macrophages of atherosclerotic plaque : effect of vitamin E supplementation. Circulation. 2000;101(11):1249-54.

61. Tsimikas S, Brilakis ES, Miller ER et al. Oxidized phospholipids, Lp(a) lipoprotein, and coronaryartery disease. N Engl J Med. 2005;353(1):4657.

62. Centers for Disease Control and Prevention. Health, United States, 2012. Selected prescription drug classes used in the past 30 days, by sex and age: United States, selected years 1988–1994 through 2007–2010. http://www.cdc.gov/nchs/data/hus/hus12.pdf#092. (accessed 2013 January 20th).

63. Lilja JJ, Neuvonen M, Neuvonen PJ. Effects of regular consumption of grapefruit juice on the pharmacokinetics of simvastatin. Br J Clin Pharmacol. 2004;58(1):56-60.

64. Fuhr U. Drug interactions with grapefruit juice. Extent, probable mechanism and clinical relevance. Drug Saf. 1998;18(4):251-72. Review.

65. Kantola T, Kivistö KT, Neuvonen PJ. Grapefruit juice greatly increases serum concentrations of lovastatin and lovastatin acid. Clin Pharmacol Ther. 1998;63(4):397-402.

66. Lilja JJ, Kivistö KT, Neuvonen PJ. Grapefruit juice-simvastatin interaction: effect on serum concentrations of simvastatin, simvastatin acid, and HMG-CoA reductase inhibitors. Clin Pharmacol Ther.

1998;64(5):477-83.

67. Lilja JJ, Kivistö KT, Neuvonen PJ. Grapefruit juice increases serum concentrations of atorvastatin and has no effect on pravastatin. Clin Pharmacol Ther. 1999;66(2):118-27.

68. Lilja JJ, Neuvonen M, Neuvonen PJ. Effects of regular consumption of grapefruit juice on the pharmacokinetics of simvastatin. Br J Clin Pharmacol. 2004;58(1):56-60.

69. Fukazawa I, Uchida N, Uchida E et al. Effects of grapefruit juice on pharmacokinetics of atorvastatin and pravastatin in Japanese. Br J Clin Pharmacol. 2004;57(4):448-55.

70. Ando H, Tsuruoka S, Yanagihara H et al. Effects of grapefruit juice on the pharmacokinetics of pitavastatin and atorvastatin. Br J Clin Pharmacol. 2005;60(5):494-7.

71. Gotto AM Jr. Safety and statin therapy: reconsidering the risks and benefits. Arch Intern Med. 2003;163(6):657-9.

72. Phillips PS, Haas RH, Bannykh S et al. Statin-associated myopathy with normal creatine kinase levels. Ann Intern Med. 2002;137(7):581-5.

73. Corsini A, Bellosta S, Baetta R et al. New insights into the pharmacodynamic and pharmacokinetic properties of statins. Pharmacol Ther.

1999;84(3):413-28. Review.

74. Kajinami K, Takekoshi N, Brousseau ME et al. Pharmacogenetics of HMG-CoA reductase inhibitors: exploring the potential for genotype-based individualization of coronary heart disease management.

Atherosclerosis. 2004;177(2):219-34. Review.

75. Omar MA, Wilson JP. FDA adverse event reports on statin-associated rhabdomyolysis. Ann Pharmacother. 2002;36(2):288-95. Review.

76. Mazokopakis EE. Unusual causes of rhabdomyolysis. Intern Med J. 2008;38(5):364-7.

ACPE UAN#: 0100-0000-14-070-H01-P 0100-0000-14-070-H01-T

Winter 2014 • Arizona Journal of Pharmacy • 43

I.

CONTINUING EDUCATION QUIZ QUESTIONS Anemia and the Role of the Pharmacist

ACPE UAN# 0100-0000-14-069-H01-P

/ 0100-0000-14-069-H01-T

1. Which of the following is not typically a sign or symptom of chronic anemia? a. Weakness b. Tachycardia c. Headache d. Cold sensitivity

b. Fish c. Eggs d. Dairy e. All of the above

2. Which medication does not decrease the absorption of oral iron products? a. Levothyroxine b. Antacids c. Cholestyramine d. Proton pump inhibitors 3. Which of the following is true regarding vitamin B12 deficiency? a. Oral therapy is not preferred due to only 10% absorption b. Pernicious anemia, a form of B12 deficiency, is characterized by high values of intrinsic factor c. Replacement therapy is rarely long term, with the issue usually resolving in 3-6 weeks d. Though a serious outcome, neurological symptoms often resolve within a few days of treatment if treated early on 4. Which oral iron product contains the highest percent of elemental iron? a. Ferrous gluconate b. Ferrous sulfate c. Ferrous fumarate d. Polysaccharide-iron complex 5. Which food is/are a good source of vitamin B12? a. Meat

6. What is the most common side effect of oral iron therapy? a. Headache b. Nausea c. Rash d. Joint pain 7. If a patient experiences the side effect describe above (#6) what is the best way to try to prevent further complications? a. Discontinue oral therapy b. Instruct the patient to take the tablets in one daily dose c. Recommend the patient takes antacids d. Recommend the patient try taking the tablets with orange juice

Use the following patient case for questions 10-12: TD is a 69 year-old female who presents with dyspnea on exertion, intermittent chest pain, cough and fatigue. Her lab values at this time are as follows: CBC

Iron Studies

Other

Hgb 8g/dL

Serum iron 9mcg/L

MCV 72 fL/cell

Hct 26.0%

Ferritin 1 ng/mL

Reticulocyte count 3.3%

RBC 3.94 x 106 uL

TIBC 490 mcg/dL

Vitamin B12 440 pg/mL

TSAT 2%

Folic acid 6.4 mcg/L

10. What type of anemia do these lab values indicate? a. Iron deficiency anemia b. Vitamin B12 deficiency anemia c. Folate deficiency anemia d. Pernicious anemia

8. True or False: Intravenous iron sucrose is FDA approved for the treatment of iron-deficiency anemia

11. Which of the following would be an appropriate treatment for TD’s condition? a. Vitamin B12 1000mcg PO daily b. Ferrous gluconate 300mg PO daily c. Folic acid 0.4mg IM daily d. Ferrous sulfate 300mg PO TID

9. Which of the following statements about folate deficiency is false? a. Laboratory evaluations will include a low MCV b. Alcoholism is a risk factor c. Green leafy vegetables are a good source of folate d. Irritability and memory impairment can be symptoms

12. Which of the following statements is false regarding TD’s therapy? a. Taking her medication with orange juice will increase its absorption b. It is expected that TD’s Hgb should increase by 5g/ dL per week c. TD may experience dark stools d. Eating meat and beans could help aid in her treatment

II. A Review of Common Drug-drug and Food-drug Interactions Associated with Cardiovascular Medications ACPE UAN# 0100-0000-14-070-H01-P / 0100-0000-14-070-H01-T

1. What is the concern regarding concomitant use of PPIs and clopidogrel? a. PPIs and clopidogrel present a duplication of therapy b. PPIs may inhibit the activation of clopidogrel causing increased CV risks c. PPIs may cause increased hepatic elimination of clopidogrel causing increased CV risks d. Toxic accumulation of PPIs may occur because clopidogrel are also metabolized by CYP2C19.

2. Which of the following medications used for the regulation of gastric acid production presents the most concern when used with antiplatelet agents like clopidogrel? a. Omeprazole b. Pantoprazole c. Ranitidine d. Famotidine 3. An elderly patient with a history of GI bleed presents to the pharmacy to refill his Plavix. He has a history of

CVD and just underwent surgery for placement of a coronary stent a week ago. You notice that he is taking Plavix with aspirin, as well as pantoprazole for bleeding prophylaxis. Your response should be: a. Consult the prescribing physician, as you should with every case taking PPIs and dual-antiplatelet therapy b. Advise the patient to space out the dosing of his PPI, at least 4 hours apart from his antiplatelet medications c. Call the hospital. The patient is at high risk of a sudden CV event d. Refill the Plavix because PPIs are indicated in this patient based on his risk for GI bleed.

CONTINUING EDUCATION QUIZ QUESTIONS CONTINUED

A Review of Common Drug-drug and Food-drug Interactions Associated with Cardiovascular Medications

ACPE UAN# 0100-0000-14-070-H01-P / 0100-0000-14-070-H01-T

4. Which of the following contributes to the concern over fish oil supplementation in conjunction with warfarin therapy? a. The cost of fish oil supplementation and warfarin therapy would be excessive b. Fish oils would inhibit the effects of warfarin therapy c. Omega-3 fatty acids may decrease fibrinogen, factor VIII, and Von Willebrand factor (vWF), which may increase risk of bleeding d. Omega-3 fatty acids may decrease protein C, which may increase risk of bleeding 5. Fish oils show benefit in reducing atherosclerosis because of their ability to a. Inhibit cyclooxygenase b. Increase prostaglandins and thromboxane c. Decrease platelet aggregation d. Modulate nuclear transcription factors 6. Patient YL has been recently discharged from the hospital following valve reconstruction surgery. She would like to continue taking her fish oil supplements for her high triglyceride levels. How would you respond to her? a. She can no longer take her fish oil supplements due to its ability to increase bleeding risk b. She can no longer take her fish oil supplements because they will no longer be effective c. She no longer needs fish oil supplementation because she had major heart surgery d. She can restart her fish oil supplements once she is cleared by her physician 7. What is the possible explanation for the drug interaction between statin drugs and grapefruit juice? a. Grapefruit juice is an inducer of the enzyme that metabolizes statins b. Grapefruit juice worsens hyperlipidemia in patients taking statin medications c. Grapefruit juice is an inhibitor of the enzyme that metabolizes certain statins. d. Grapefruit juice is an inhibitor of the enzyme that matabolizes all statins.

8. Mrs. Jones is a 55 year-old female who was prescribed a new drug regimen for her CONTINUING EDUCATION

hyperlipidemia. (Simvastatin 20mg PO daily). However, after watching Dr. Oz talk about drug side effects on TV last night, she is hesitant to take her medication and asks for your opinion. What would you tell her? a. Statins are known to be safe medications with no significant drug interations b. Statins are associated with side effects involving muscle pain and disorder c. Drinking large quantities of grapefruit juice regularly while on this medication could result in a rare but serious muscle disorder d. B and C 9. According to new hyperlipidemia guidelines, niacin would be recommended to treat hyperlipidemia for which of the following patient populations? a. First-line for a patient newly diagnosed with dyslipidemia b. With elevated non-HDL-C and at target LDL-C to reduce ASCVD outcomes c. With high-risk and intolerant to statin therapy d. Not recommended given the lack of support in clinical trials 10. Which statement is correct about niacin formulations? a. IR products are associated with hepatotoxicity b. Niaspan is the only FDA approved ER product and has relatively moderate risks of hepatotoxicity and flushing c. SR products are associated with flusing d. All formulations (IR, SR, and ER) are available OTC. 11. RYR is a dietary supplement that a. Is actively regulated by the FDA because it contains a FDA regulated drug b. Is considered to be illegally marketed if it contains monacolin K c. Has been found to have consistent levels of active ingredients d. Is recommended as an alternative or adjunct therapy in updated hyperlipidemia guidelines.

12. A woman approaches you stating she heard RYR is a natural product that

could help with her cholesterol. She is currently not taking anything for hyperlipidemia due to finances. What should be a justified recommendation? a. Yes, take RYR because it contains a FDA regulated drug used for hyperlipidemia b. Yes, tkae RYR but only purchase a product with consistent levels of monacolin K c. No, do not take RYR because it has not been shown to be effective d. No, taking RYR is not recommended due to quality concerns as well as safety concerns 13. Mrs. Young is a 50-year old female who is taking Atorvastatin 20mg PO daily for hyperlipidemia. After talking to her, you discover that she is also taking a daily dose of St. John’s word 600mg for depression. What is (are) the appropriate counseling point(s) for Mrs. Young? a. St. John’s wort is a safe and effective, FDA-approved treatment for depressive disorders b. There is a risk of potentially harmful drug interaction if atorvastatin is used with St. John’s wort c. St. John’s wort may decrease the efficacy of atorvastatin d. B and C. 14. What is the possible explanation for the interaction between St. John’s wort and Statin drugs? a. St. John’s wort is an inducer of CYP3A4 and P-gp b. St. John’s wort is a competitive inhibitor of statin drugs c. St. John’s wort is an inhibitor of CYP3A4 and P-gp d. Statins enhance the therapeutic effect of St. John’s wort 15. What is a possible adverse drug event associated with the consumption of large quantities of grapefruit juice on statin therapy? a. Rhabdomyolysis b. Stevens-Johnson Syndrome c. Reye Syndrome d. Acute pancreatitis

Winter 2014 • Arizona Journal of Pharmacy • 45

Continuing Education Answer Sheet:

I.

Anemia and the Role of the Pharmacist ACPE UAN#0100-0000-14-069-H01-P

CE Assessment Answers - Please circle your answers (one answer per question.)

1. a. b. c. d.

7. a.

2. a. b. c. d.

8. True 3. a. b. c. d.

9. a.

4. a. b. c. d.

10. a.

5.

6.

0100-0000-14-069-H01-T

Activity accredited date: 12/15/2014 Expiration date: 12/15/2017. This activity is accredited for 1 hour 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. Complete the quiz / eval below or take the quiz online at azpharmacy.org/ajp_winter/anemia/069

a. a.

b. b.

c. c.

d. d.

e.

11. a.

12. a.

Questions on page 46. b. c. d.

False b. c. d. b. c. d. b. b.

c. c.

d. d.

ACTIVITY EVALUATION – Must be completed to receive credit.

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

AGREE DISAGREE 2. Please rate the activity based on the following (please circle one): • Overall evaluation of the article content:

Poor 1 2 3 4 5 Excellent • Relevance to pharmacy practice Poor 1 2 3 4 5 Excellent • Value of the content Poor 1 2 3 4 5 Excellent 3. The information presented (check all that apply):

Reinforce my current practice/treatment habits Will improve my practice/patient outcomes Provided new ideas or information I expect to use Adds to my knowledge 4. Will the information presented cause you to make any changes to your style or method?

Yes No 5. Will the information presented cause you to make any changes in your practice?

Yes No 6. How committed are you to making these changes?

Not committed 1 2 3 4 5 Very committed 7. Do you feel future activities on this subject matter are necessary and/or important?

Yes No

II.

A Review of Common Drug-drug and Food-drug Interactions Associated with Cardiovascular Medications ACPE UAN#0100-0000-14-070-H01-P

0100-0000-14-070-H01-T

Activity accredited date:12/15/2014 Expiration date: 12/15/2017. This activity is accredited for 1.5 hours of CPE credit (CEUs 0.15) In order to qualify for ACPE credit, participants must achieve a grade of 70% or above on the quiz and submit a completed activity evaluation.

Complete the quiz / eval below or take the quiz online at azpharmacy.org/ajp_winter/fooddrug070 C

CE Assessment Answers - Please circle your answers (one answer per question.)

1. a. b. c. d.

8. a.

2. a. b. c. d.

9. a.

3. a. b. c. d.

10. a.

4. a. b. c. d.

11. a.

Questions on page 45 & 46. b. c. d. b. c. d. b. c. d. b. c. d.

5.

6.

a. a.

b. b.

c. c.

d. d.

12.

13.

a. a.

b. b.

c. c.

d. d.

7.

a.

b.

c.

d.

14. a.

15. a.

b. b.

c. c.

d. d.

ACTIVITY EVALUATION – Must be completed to receive credit.

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

AGREE DISAGREE 2. Please rate the activity based on the following (please circle one): • Overall evaluation of the article content:

Poor 1 2 3 4 5 Excellent • Relevance to pharmacy practice Poor 1 2 3 4 5 Excellent • Value of the content Poor 1 2 3 4 5 Excellent 3. The information presented (check all that apply):

Reinforce my current practice/treatment habits Will improve my practice/patient outcomes Provided new ideas or information I expect to use Adds to my knowledge 4. Will the information presented cause you to make any changes to your style or method?

Yes No 5. Will the information presented cause you to make any changes in your practice?

Yes No 6. How committed are you to making these changes?

Not committed 1 2 3 4 5 Very committed 7. Do you feel future activities on this subject matter are necessary and/or important?

Yes No PARTICIPANT INFORMATION: Name ________________________________________ Phone _______________________________________

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