AJP Fall 2014

Fall 2014 Vol. 6, No. 3

Arizona Journal of Pharmacy

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

Ann Sears, R.Ph. AzPA President 2014-2015

Fall 2014 • Arizona Journal of Pharmacy • 1

(flunisolide) inhalation aerosol

Introducing

The only ICS available with a built-in spacer

ICS=Inhaled corticosteroid.

Indications AEROSPAN Inhalation Aerosol is indicated for the maintenance treatment of asthma as prophylactic therapy in adult and pediatric patients 6 years of age and older. AEROSPAN Inhalation Aerosol is also indicated for asthma patients requiring oral corticosteroid therapy, where adding AEROSPAN Inhalation Aerosol may reduce or eliminate the need for oral corticosteroids.

Important Limitations of Use: AEROSPAN Inhalation Aerosol is NOT indicated for the relief of acute bronchospasm. AEROSPAN Inhalation Aerosol is NOT indicated in children less than 6 years of age.

Important Safety Information

AEROSPAN Inhalation Aerosol is contraindicated as a primary treatment of status asthmaticus or other acute episodes of asthma requiring intensive measures.

AEROSPAN Inhalation Aerosol is not a bronchodilator and is not indicated for rapid relief of bronchospasm.

In clinical studies with flunisolide, localized fungal infections of the mouth, pharynx, and larynx have occurred. If oropharyngeal candidiasis develops, AEROSPAN Inhalation Aerosol therapy may need to be interrupted under close medical supervision.

Patients should be instructed to contact their physician immediately when episodes of asthma that are not responsive to bronchodilators occur during the course of treatment with AEROSPAN Inhalation Aerosol. During such episodes, patients may require therapy with systemic corticosteroids.

Patients who are on drugs that suppress the immune system, such as corticosteroids, are more susceptible to infections than healthy individuals and should avoid exposure to chicken pox or measles. Inhaled corticosteroids should be used with caution, if at all, in patients with untreated active or quiescent tuberculosis infection of the respiratory tract; untreated systemic fungal, bacterial, parasitic, or viral infections; or ocular herpes simplex.

During reduction and withdrawal of oral corticosteroid doses, patients should be carefully monitored for asthma instability, including objective measures of airway function, and for adrenal insufficiency. Patients should taper slowly from systemic corticosteroids if switching to AEROSPAN Inhalation Aerosol.

Please see Full AEROSPAN Prescribing Information available at this booth.

Contact Meda Pharmaceuticals Inc. at 855-653-6325 Š2014 Meda Pharmaceuticals Inc. 03/14 AER-14-0048

It is possible that systemic corticosteroid effects such as hypercorticism and adrenal suppression may appear in a small number of patients, particularly at higher doses. If such changes occur, reduce the AEROSPAN Inhalation Aerosol dose slowly, consistent with accepted procedures for management of asthma symptoms and for tapering of systemic corticosteroids.

Decreases in bone mineral density have been observed with long-term administration of products containing inhaled corticosteroids, including flunisolide. Patients with major risk factors for decreased bone mineral content should be monitored and treated with established standards of care.

Orally inhaled corticosteroids, including flunisolide, may cause a reduction in growth velocity when administered to pediatric patients. Monitor the growth of children and adolescents receiving AEROSPAN Inhalation Aerosol. To minimize the systemic effects, patients should be titrated to the lowest dosage that effectively controls symptoms.

Glaucoma, increased intraocular pressure, and cataracts have been reported in patients following the long-term administration of inhaled corticosteroids, including flunisolide. Therefore, close monitoring is warranted in patients with a change in vision or with a history of intraocular pressure, glaucoma, and/or cataracts.

Bronchospasm may occur with an immediate increase in wheezing after dosing.

If bronchospasm occurs following dosing with AEROSPAN Inhalation Aerosol, treat immediately with a fast-acting inhaled bronchodilator. Discontinue AEROSPAN treatment immediately and institute alternative therapy.

The most common adverse reactions seen in two 12-week, pivotal, double-blind, placebo-controlled, clinical trials performed with AEROSPAN (160 mcg BID) were pharyngitis (16.6%), rhinitis (15.7%), headache (13.8%), cough increased (5.5%), allergic reaction (4.6%), and vomiting (4.6%).

Arizona Journal of Pharmacy

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

Vol. 6, No. 3

FALL 2014

In This Issue ....

President’s Message CEO’s Message Featured Articles

4 5

A Look Back - Antacid Container

Time Capsule CASE REPORT: Breathalyzers + Inhalers = the Potential for False-Positives Risk of Serotonin Syndrome with Concomitant Use of SSRI/SNRI and Triptans Roundtable on Continous Quality Assurance Arizona Delegates Report on 66th Annual Session

13 13 14

17 20 25

Departments Association News New Members

Annual Convention Recap PAPA Legislative Update Arizona State Board of Pharmacy Technician Spotlight

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

• Health-System Academy

• Managed Care Academy

• Student Pharmacist Academy • Technician Academy Continuing Education

Pharmacotherapy for Weight Loss New Rules for CPE Monitor Reporting Geriatric Patient Care: Systematic Review

6 6 8 9 10 11 12 27 30 30 31 31 32 32 33 33 37 38

Advertisers Meda Pharmaceuticals PTCB Clearant PAAS Pharmacy Quality Commitment Pharmacists Life Insurance Rx Relief

www.azpharmacy.org

Editor

Kelly Ridgway, R.Ph. Chief Executive Officer

Editorial Board

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

2 11 16 26 26 47 48

Managing Editor

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

Fall 2014 • Arizona Journal of Pharmacy • 3

President’s Message It’s an honor and privilege for me to serve as the President of AzPA for 2014-2015, thank you to everyone for making me feel so welcome. I would also like to specifically thank Kelly - our CEO - the amazing AzPA staff, and the outgoing and incoming boards for their commitment to AzPA. We are truly blessed.

My vision for next year: Cooperation When I was 12 years old, I wanted to become a pharmacist. That goal never changed. I am one of the lucky ones, because I am living my dream. Somtimes it is easy to forget about dreams when we are living the day to day.

It doesn’t matter whether we are students, technicians, or pharmacists. It doesn’t matter where we work.

Most of us joined pharmacy or healthcare, because we wanted to make a difference. We wanted to help improve patients’ lives. Our last convention’s theme was Pharmacists as Providers, Changing the Game. I submit to you that pharmacy and playing games actually have some similarities.

Games boil down to two types: competitive and cooperative. Pharmacy, healthcare, and life for that matter, falls into these same two categories. I believe that we make conscious and unconscious choices to be competitive or cooperative every day. We see this in our relationships at home and with our friends, on the job, in our profession and in our communities. There is nothing wrong with healthy competition; especially, if we let it bring out the best in us or make positive strides for our patients.

The AzPA mission is to educate, advocate for, protect and advance the profession of pharmacy in this state.

We made great strides this last year in moving forward on the Pharmacists as Providers issue, but we have a lot more work to do on many issues still ahead. The staff of AzPA, Kelly as CEO, and the Board cannot effect change in this state alone.

My mission this year is to change the game to one of cooperation, but I need your help. Join me. Become a member of AzPA if you aren’t already. If you are a member, get involved. Share your unique talents with us, so we can utilize your abilities in the best possible area. Members, link your Fry’s card to the AzPA code. Buy your gift cards from the AzPA office. Do you need something from Amazon? Go to azpharmacy.org and click on the amazon link before you shop. Those few things cost you nothing extra, but go a long way to helping the AzPA mission. Go further and support pharmacy political action by making a contribution to PharmPAC. Invite others to join AzPA. Ask them to contribute to our team. Already doing all of these things – I thank you. Let’s always remind each other that we all matter and we all have something important to contribute.

Protecting the future of pharmacy in this state is in all of our hands and I hope that you feel empowered, excited, and welcome to be a part of our cooperative team. I look forward to this year and all that we can do together.

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

CEO’s Message As we approach a new fiscal year at AzPA, and charge forward with our new President, Ann Sears, the message of leadership seems to be a timely one. The pharmacy profession is reaching a tipping point. We are expanding and changing more rapidly than any other health profession and we need leaders now more than ever. Our profession is embarking on a quest to obtain national provider status for pharmacists under Medicare Part B. Most states are also modifying state practice acts to coincide with the national efforts. This requires time, money, resources, perseverance and leaders to champion this effort in our local communities.

Leadership does not require serving as a pharmacy director or on the board at a state or national pharmacy association - although those positions are important - being a leader in pharmacy starts with your daily interactions with your patients, coworkers and community. You represent our profession and you impact how people perceive pharmacists. Pharmacy leaders do all they can do to protect their patients, improve patient care, advance and protect their profession no matter what practice setting they work in, no matter their title, and no matter the years of experience, residency training, etc.

Although you have taken the important step participating in your state pharmacy association, how many of your colleagues have? I genuinely believe that involvement and engagement in your state and respective national association is essential in order to preserve and advance our profession. This is not a one way relationship. Active involvement allows you to stay connected and keeps the “pharmacy fire” burning, the fire that was started when you stepped onto your college of pharmacy campus for the first time, the fire that fuels the desire you feel to make a difference, the fire that produces change and innovation in our profession.

Something happens when you are involved and surrounded by others who are committed to the same goal of advancing the profession; it keeps you energized and motivated about the profession of pharmacy.

One of my favorite quotes on leadership: “One of two things will happen if we do not lead: Either no one will lead and there will be chaos or someone will fill the vacuum who doesn’t share our values,” - Condoleezza Rice Leadership entails the ability to lead and grow your own ambitions while others, but it also means serving first.

True leaders bring others along to help them grow, so that they can one day be leaders too.

I stand here, not as your state association CEO, but as a fellow pharmacist. I, like all of you, have a desire to serve and advance the profession. I need your help and expertise to make provider status for pharmacists a reality at the state level. Your national association CEOs need your help to make it happen. Get involved, bring along a friend, find a mentor and share what pharmacists can and are doing in the lives of our patients.

Arizona Pharmacy Association

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

Fall 2014 • Arizona Journal of Pharmacy • 5

ASSOCIATION NEWS WELCOME NEW MEMBERS PHARMACISTS Nilesh Agrawal Majed Al Yami Amy Bataoel Chris Brettfeld Eric Burke Jamie Chichester Kenneth Daniels Missy Duke Dorian Hollingworth Foster John Howell Kimberly Kustron Stephanie Sanders Michael Smith Margie Stevens Wendy Toler Thomas Wennergren

ASSOCIATES Angie Dik John Dik Rachel Ray

TECHNICIANS Adriana Carrasco So Dong Jyia Gilmer Elizabeth Simpson Timothy Tribble Luz Vasquez-Rashan Jie Zhou

STUDENTS Zachary Brown Matteo Buompensiero Paris Cook Bob Curry Marcelia Dorman Cesar Figueroa Araksya Gluazaryan William Grandt Nicole Graybill Michael Griffith Dominick Grosso Maduni Hemachandra Yulia Ilyushenko Melissa Johnson Elvina Karabas Marilyn LaBash Zachary Lancaster Ngoc Le

Vahe Lepedjian Rebecca Lunt Franco Marzella Steven Meade Hadley Neidhardt Magdalene O’Toole Kari Quimbiulco Emily Ramirez Joseph Simonsen Lacey Simpson Phuong Tran Brian Win Loc (May) Woodland

Cheers for Volunteers!

The Arizona Pharmacy Association staff is here to support YOU - our members. We acknowledge the contributions of the volunteers who have made a difference for our organization and their fellow pharmacy professionalsThank you for all you do!

Talia Akoh-Arrey Mark Bank Mark Boesen Mitchell Buckley Kacey Caroll Dimpa Choski Joe ElAshkar Pearce Engelder Martin Faridian Sophia Galloway Dawn Knudsen Gerber Lisa Goldstone Jonathan Griffin Tom Van Hassel Richard N. Herrier

Marcella Honkonen Rebekah M. Jackowski William Jones Lindsay Kittler Nicole Kitts Sara Kastrati Marilyn LaBash Karen Lewis Bob Lipsy Betty Louton Monica Malapit Evan Mallory Grant Metcalf Nicole Murdock

John E. Murphy Saul Ortega Reema Patel Quan Pham Elizabeth Pogge Whitney Rice Harshal Shah Jay Sheth Elliott M. Sogol Rosy Vallin

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

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

VISION Empowering pharmacy professionals to provide optimal patient care.

Stay connected!

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

SAVE THE DATE! FALL CONFERENCE Psychiatric Certificate Program

6.0 CE hours

A

Diabetes Meter Training Workshop (Pharmacy Technicians only) SGLT2 Inhibitors in Diabetes Management

to pa op pro ti ti vi en m d t al e ca re

#azpaFall

g in er y s w ac al po rm on m a si E ph fes o pr

Stay connected on Social Media with hashtag

y l al c e F ma nc r re ha fe on C

Diabetes Certificate Program

P Ari h ss ar zon oc m a ia ac ti y on

Saturday, Nov 15 P

Friday, Nov 14

Medical Devices in Pharmacy Practice And more!

NOVEMBER 14-15, 2014 Kroc Corps Community Center, Phoenix SAVE when you register EARLY! Register today! azpharmacy.org

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

ONLINE CAREER CENTER

www.azpharmacy.org/jobs

Do you know someone who is not a member of the Arizona Pharmacy Association?

Invite them to join the only statewide organization that represents the pharmacy profession in Arizona.

Annual dues for a pharmacist are just $20 per month!

Visit the AzPA website at www.azpharmacy.org to join online or to download a printable Membership Investment Statement.

Association News

IN MEMORY OF ...

Dr. Oliver (Ollie) V. Waite, Jr., (1931 - May 1, 2014) Dr. Waite was a longstanding member of AzPA. He served and fought as a Marine in the Korean War. He worked as a pharmacist in Nebraska. Then he moved to Scottsdale, Ariz., where he conducted clinical research for 20 years and taught as a professor at DeVry University. At the age of 83, he was diagnosed with cancer and passed away a month later.

We offer our condolences to Dr. Waite’s family: his wife Mary Anne; sons, Terry (Karen), Tim (Kristie) and Tom (Rachel); daughters, Elizabeth (Dan), Katie (Wayne), Mary Ellen (James) and Sheila (Chris); brother, Robert, and sister, Judith; as well as his 28 grandchildren and 19 great grandchildren.

Fall 2014 • Arizona Journal of Pharmacy • 7

RECAP: 2014 Annual Convention The 2014 Annual Convention at Wigwam Resort in Litchfield June 26-29th was a success! We had about 400

pharmacy professionals attend in support of AzPA. Pharmacists, student pharmacists, pharmacy technicians and others in the industry participated in more than 20 continuing pharmacy education activities, social functions and informal product sessions. Congratulations to all convention award recipients. Thank you to our exhibitors and sponsors whose contributions helped make the annual convention a hit.

2014 AzPA Exhibitors and Sponsors

CONGRATULATIONS 2014 CONVENTION AWARD WINNERS! Oustanding Leadership Award Ray Clark, Pharm.D.

Generation Award Keith Boesen, Pharm.D.

Pharmacy Appreciation Award Jonathan Merchen, Pharm.D., BCPS Mindy Throm Burnworth, Pharm.D., BCPS Nicole Kitts, Pharm.D. Grant Metcalf, C.Ph.T. Ruben Vital

AzPA Hall of Fame Terry Daane, R.Ph. Ted Tong, Pharm.D. Paul Draugalis, R.Ph. Roger Morris, R.Ph., JD Hal Wand, R.Ph., MBA Dennis McAllister, R.Ph. Kathryn Kalsman, R.Ph. Michael Kalsman Llyn Lloyd, R.Ph. University of Arizona Class of 1951

Honorary Life Membership James Morrison, R.Ph. Distinguished Young Pharmacist of the Yr Rose Martin, Pharm.D. Pharmacist of the Year Award Kevin Boesen, Pharm.D. 2014 AzPA Fellows Mindy Throm Burnworth, Pharm.D., BCPS Kristina De Los Santos, Pharm.D., BCPS Carol Rollins, M.S., R.D., Pharm.D., BCNSP FASPEN, FASHP Outgoing President Award Ray Clark, Pharm.D. Pharmacy Leadership Ann Sears, R.Ph. Incoming President Award Ann Sears, R.Ph.

Technician of the Year Award Christina Abedi, C.Ph.T. Elias Schlossberg Award Mary Manning, Pharm.D., BCPS Bowl of Hygeia Award Crane Davis, Pharm.D. Exemplary Patient Care Award Bao Nguyen, Pharm.D. Excellence in Inovation Laura Tsu, Pharm.D., BCPS, CGP Nicole Murdock, Pharm.D., BCPS Outstanding Pharmaceutical Rep Greg Larson

Allison Medical, Inc. American Regent AmerisourceBergen Arizona Health-e Connection Arizona Pharmacy Foundation ARKRAY Astra Zeneca Diabetes AstraZeneca LP Banner Health Boehringer Ingelheim Bristol-Myers Squibb CAPS/B.Braun Medical Inc Cardinal Health Cubist Pharmaceuticals Eli Lily Express Scripts Freedom Pharmaceuticals Fry’s Pharmacy Germfree Laboratories, Inc. Grifols Humana RightsourceRx Intelliguard® Kit & Tray Management McKesson MEDA Pharmaceuticals MedImmune Merck Vaccines Midwestern University National Alliance of State Pharmacy Assoc.

National Community Pharmacits Assoc.

Nephron Pharmaceuticals Corp.

Noven Women’s Health Novo Nordisk Otsuka America Pharmaceuticals, Inc. Pfizer Pharmacists Mutual Insurance Companies PharMEDium Services, LLC Pharmacy Network of Arizona PharmPAC PhRMA Rare Disease Therapeutics Roche Diabetes RxRelief Safeway Sanofi SinfoniaRx Staring Down the Barrell Sunovion Pharmaceuticals Universal Medical Data University of Arizona Upsher-Smith Laboratories

Pharmacists Assisting Pharmacists of Arizona (PAPA) Conference at University of Utah School on Alcoholism and Other Drug Dependencies: A Personal Perspective

By Ryan

As I approached Salt Lake City this past June, I could see the salts flats out my window for the first time while our plane was circling above the runway. I could only imagine the vehicles, trials and land speed records that have raced across the vast flat sea of white. Little could any of us have known that our week would pass with similar velocity and celebrations as students and pharmacists gathered for the 63rd annual University of Utah School on Alcoholism and Other Drug Dependencies.

APhA has been helping organize a pharmacy section at this conference since the early 80’s. This section is by far the largest with around 200 pharmacists and student pharmacists attending. During our first session we were exposed to the commitment and love several ‘Old Timers’ had poured into the school over the years. Many of our mentors were returning for their 20th plus year. After our introductory session many students were exposed to their first ever 12 step meeting of Alcoholics Anonymous. Formalities were explained, readings read, and then the personal testimony began. It was humbling to be surround by so many miracles in Recovery. Looking around the room there seemed to be two main reactions being felt amongst first time attendees, either eyes wide open in astonishment and awe or tears of yet unexplainable emotions.

Monday morning threw a quick jab our direction. It was announced that this would be the last ever Utah School as we know it. I talked to many students who prior to this announcement were already thinking about next year and who they could recruit to bring back, after only an 18 hour experience. The Utah School moved most of us immediately. But, it wasn’t over yet, so we all settled in to embrace this last week.

Our keynote speaker was Dr. Kevin McCauley. I urge anyone who has been touched by addiction, either personally or through a friend or family member, to spend some time learning about Dr. McCauley. His story is absolutely remarkable. He provided us all a personal encounter of the nature of addiction and did an excellent job answering the question of whether addiction is truly a disease. Look him up, it’s worth your time.

Wednesday morning we experienced the unique opportunity of sitting in on a therapy rehabilitation small group session. Volunteers from a local facility had their small circle of 10 or so patients and counselors who were surrounded by our 200 person audience. I would have been intimidated for certain but there was something special witnessing that moment. To hear those actively being treated for addiction(s) talk through their situations, drum up old, buried emotions, and get honest with a group of strangers was no small act. Time and time again the Utah School proved to be much more than the science behind addiction and the problems that plague our pharmacies. These were real people, real stories, and real intense emotions.

That evening was an open Al-Anon meeting. After several days of lectures, group discussions, and 12 step meetings those newcomers finally had a voice, a vocabulary and an opportunity. Struggles were talk mentioned, emotions validated, and love shared. Especially after attending this conference I am convinced we all have personal stories regarding addiction whether it’s through firsthand accounts or not. The atmosphere of that meeting and all meetings that week was of healing, hope, and community. This was a truly amazing experience!

So yes, the Utah School may have held its last conference in this capacity but I have not said bye to my memories made that week. With the passion that flows though the Old Timers and into the new students, I am confident somewhere will step up. With the help of APhA and Pharmacy Recovery Networks around the country, this school’s content and message will continue.

The science and treatments of addiction will continue to improve. Those who first attended in the 50’s probably couldn’t fathom how far we have come already. In all sincerity, however, I won’t remember much of the many hours of lectures. I will never forget the faces, the stories, the how the other attendees made me feel though.

After going to event such as the Utah School I have little doubt that we are all the same. We all get angry, we all cry, and we all have been touched by this terrible disease. Those that are in recovery are said to share in a common peril, that of rescued shipwreck passengers. Through their common trials, and now solution, they can join in brotherly action.

Those lucky enough to have attended the Utah School have forged that brotherhood. As we raced off to our ordinary lives I know we all want to be part of the solution moving forward, bringing those lessons learned of compassion and hope back into our everyday practices.

Fall 2014 • Arizona Journal of Pharmacy • 9

LEGISLATIVE UPDATE Pharmacists as Providers Bill Passes in Arizona On April 22, 2014, Arizona joined 34 other states by recognizing pharmacists as medical providers. This legislation puts Arizona pharmacists in a better position to be reimbursed for pharmacist patient care services under a national bill, HR 4190. If enacted at the national level it would give patient access to these services under Medicare Part B in medically underserved communities.

AzPA has helped to pass a series of legislative changes that have advanced the role of pharmacists in Arizona.

• 2009: HB 2164 allows pharmacist to immunize adults without a prescription • 2011: SB 1298 authorizes student pharmacists to vaccinate, allows pharmacists to vaccinate children 6-17 years and expands the opportunities for Collaborative Practice agreements to include any pharmacy practice setting • 2013: SB 1188 clarifies the authority of Arizona pharmacists to prescribe adult immunizations and childhood flu vaccine as well prescribe and subsequently write prescription orders for any medication authorized under a provider signed Collaborative Practice Agreement • 2014: SB 1043 recognizes pharmacists as medical professionals providing services within the Pharmacy Practice Act. Passage of HR 4190 would have a big impact on Arizona’s pharmacists. The bill allows for payment of services in “ medically underserved” regions. 93% (14 out of 15) Arizona counties are deemed to be medically underserved. Thus, this bill could prompt private insurers to pay for pharmacists’ medical services.

2015 Legislative Agenda: • Medication Synchronization

o Medication synchronization refers to the process of a pharmacy coordinating all of a patient’s chronic prescription medications to be filled on the same date each month.

o Legislation would aim to eliminate barriers to the implementation of medication synchronization, a service that has been shown to improve rates of medication adherence and thus, lower overall health care expenditures.

• Fair Audit

o Insurers, or the insurer’s pharmacy benefit manager (PBM), have the ability to audit pharmacies.

Well over 30 states have passed legislation to create standards for such audits. These statues create, among other things: notice requirements, establish periods of time such audits can go back, prohibit “extrapolation” (assuming an error rate for a small audit sample applies across all prescriptions and thus rescinding payment).

• Immunization Expansion:

o Currently, pharmacists are limited in the ability to immunize children under age 17 (prescription only, except for flu). There is a desire to lower the 17year age limit to allow parents of older children greater access to immunizations.

• Others:

o Additional topics were brought up. Members and the AzPA Board of Directors are discussing these topics: Any Willing Pharmacy & MAC pricing.

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

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

Arizona State Board of Pharmacy Changes to CSPMP Delegate Process Notice to Pharmacists, Pharmacy Interns, Pharmacy Technicians, and Pharmacy Technician Trainees On March 24, 2014, Governor Brewer signed Senate Bill 1124, an Act amending Sections 36-2604 and 36-2608, Arizona Revised Statutes, relating to the Controlled Substances Prescription Monitoring Program. The law becomes effective on July 24, 2014.

The Bill made changes to A.R.S. 36-2604 that affect Arizona Prescribers and Dispensers. Subsection C of A.R.S. 36-2604 is changed to allow “a delegate who is authorized by the prescriber or dispenser.” A.R.S. 36-2604 is further changed by adding Subsection E that defines “Delegate.” A delegate “means a licensed health care professional who is employed in the office of or in a hospital with the prescriber or dispenser or an unlicensed medical records technician, medical assistant or office manager who is employed in the office of or in a hospital with the prescriber and who has received training regarding both the Health Insurance Portability andAccountability Act privacy standards, 45 Code of Federal Regulations Part 164, subpart E, and security standards, 45 Code of Federal Regulations Part 164, subpart C.” Pharmacy Interns, Pharmacy Technicians, and Pharmacy Technician Trainees will be allowed to request access to the database and look up patient data for the pharmacist to review and act on in filling prescriptions for patients.

Registration, the request will have to be approved by at least one supervisor before the delegate will get an email with a user name and password. A Supervisor must have a current access user account. A Supervisor will login to the Database and go to My Account to approve or revoke Delegates. When a Delegate makes a patient request for data, the Delegate will have to pick a Supervisor under whose DEA or State License the request will be made.

Supervisors will be able to see all requests made by their approved delegates.

If you have questions about the changes, contact Dean Wright, PMP Director at 602-771-2744 or email at dwright@azpharmacy.gov or Cindi Hunter, PMP Program Manager at 602-771-2732 or email at chunter@azpharmacy.gov.

Pharmacists Say it Best …

“I have been a pharmacist for almost 20 years.

During this time, I have seen the pharmacists’ role evolve and become more focused on the clinical aspect of care. As a result, the smooth and efficient operation of today’s pharmacy requires the expertise of a Certified Pharmacy Technician. When considering to hire someone, I look for the familiar PTCB CPhT. When I see that initiative, I know that the applicant has, at a minimum, the basic knowledge to meet the needs of my department.”

The Board of Pharmacy’s Controlled Substances Prescription Monitoring Program (CSPMP) is working with its software vendor, Optimum Technology, to implement the software enhancements necessary to allow delegate access accounts. The process has begun, but will not be ready for use until late August or early September 2014.

The process for delegates to request access to the database will be similar to the process for prescribers and dispensers (pharmacists). The delegate will go to www.azrxreporting.com, click Register, and then pick a Job Type, either Prescriber Delegate or Pharmacist Delegate. The delegate will complete and submit the New Delegate Registration form online. Prescriber Delegates will pick a Supervisor using the Prescriber’s DEA number and Pharmacist Delegates will pick a Supervisor using the Pharmacist’s State License number. Delegates will be able to pick multiple supervisors. After a delegate submits the New Delegate

—Laura Forbes, RPh, Director of Pharmacy Services, Gov. Juan F. Luis Hospital and Medical Center, Christiansted, U.S. Virgin Islands

Certification Excellence

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.

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:

Fall 2014 • Arizona Journal of Pharmacy • 11

TECHNICIAN SPOTLIGHT INTERACTING WITH PATIENTS

by Kalani Anderson, C.Ph.T

Linda Peralta has been an integral part of the Medication Management Center pharmacy team at the University of Arizona Pharmacy in Tucson, AZ since she began working there three years ago. This pharmacy ensures safety and optimal healthcare for their patients by helping them and their physicians stay on top of Linda Peralta, medication regimen.

C.Ph.T. Specifically, Linda reconciles medication lists over the phone with patients and enters both prescription and OTC drugs into the pharmacy computer system which helps alert her to potential drug and illness interactions as well as cost-saving opportunities for the patient. With drug and illness interactions or other concerns, Linda immediately connects the patient to a pharmacist for counselling, who will work with the patient’s physician/s to determine the best course of action. For example, one patient chose to stop taking a medication they felt was redundant, but Linda recognized the problem and got the pharmacist on the phone to explain why each medication was important for their health. When Linda discovers patients who are currently taking a brand name version of a drug, she can inform the patient of generic alternatives and fax their physician for approval to switch to the generic helping keep costs down not only for the patient, but for the pharmacy as well.

Linda’s pharmacy also plays a part in a smoking cessation program in conjunction with MedImpact (https:// www.medimpact.com/) and Ashline (http://www. ashline.org/). Linda fields phone calls from individuals who wish to quit smoking. The pharmacist then reviews medications that can help them succeed, and Linda faxes requests to the patient’s physician. Upon physician approval, the patient begins the process and is connected to Ashline to work with a “quit coach.”

Linda is involved throughout the process in a supportive role with follow up calls to the patient offering encouragement and ensuring they are doing well on their medications, providing a lifeline for people who are making a very difficult life change.

Linda’s favorite part of her job is the interaction with patients over the phone, and she is very good at it too.

According to her co-worker, Kelly, “Linda’s kind manner with patients has helped me learn to better engage the patients I speak with.”

A large portion of patients who call in to this pharmacy are on Medicare Part D and are older individuals with long lists of medications, lots of questions, difficulty hearing and occasionally poor short-term memory. She says patience is a must for success in this job.

A desire to work in a healthcare profession with minimal exposure to blood or other bodily fluids led Linda to a career as a pharmacy technician. After finishing the technician training program at Apollo College (since renamed Carrington College), Linda worked at a family retail pharmacy called Jones United Drug. When Jones closed its doors, Linda began working for Reed’s Compounding Pharmacy which had been part of Jones. Later she gained hospital experience working St. Mary’s Inpatient Pharmacy and has also spent time working in a call center doing prior authorizations for an insurance company. A combination of skills learned in all of these settings has helped Linda become a great co-worker and employee in her current work environment.

Rose, a pharmacist Linda has worked with, said “Linda Peralta is an exemplary pharmacy technician. She is not only reliable and dependable, but the dedication that she has to delivering high quality patient care is something we all can strive for.”

Linda feels that success for a pharmacy can be obtained by creating a solid team by facilitating fluid communication. As a technician, it is important to accept responsibility, take initiative, and go out of your way to help anyone who needs a hand. Two-way communication is crucial: technicians need to be willing to share suggestions, ask questions, and respond to new information positively and quickly. Pharmacists can help by communicating big changes in procedures as well as developments throughout a given day to technicians and other team members. Pharmacies that succeed in creating an atmosphere of openness have been at the top of Linda’s list of great places to work.

In her spare time, Linda enjoys the great outdoors with her two children, walking neighborhood trails, frequenting local parks, and swimming. If you would like to contact Linda with questions or for networking, send her an email at linda.peralta22@cox.net.

FEATURES A Look Back - Antacid Container

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

Illustrated is an apothecary jar from 1890 containing calcium bicarbonate and a tin of antacid powders from about 1940. Calcium carbonate was mentioned as a therapy as “creta alba” in the London Pharmacopoeia of 1650.

Experiments neutralizing stomach acid with magnesia alka and calciae horn of deer were correctly performed and described by Joseph Black of Edinburgh in a thesis published in 1754. The first United States Pharmacopoeia, 1820, mentions calcis carbonus.

The mantra that was repeated for years: “no acid, no ulcer” was stated in 1910 and it became the battle cry of gastroenterologist for the next 80 years. Bertram W. Sippy of Chicago became the leader in advocating the complete neutralization of hydrochloric acid. His careful research provided the basis for the “Sippy regimine.” His program required hourly milk and cream feedings alternating with hourly calcium and sodium bicarbonate in vary proportions. Later very soft bland foods were added as well as atropine for its antisecretory effect and aspiration of gastric acid by an Ewald tube. Side effects of constipation, alkalosis, mental confusion and even renal failure were not infrequent. Sometimes four to six weeks of hospitalization was required to complete the regimine.

Diet, antacids, and gastric aspiration became less important after the introduction of H2 blockers for reduction of acid. Next, the proton pump inhibitors provided for complete reduction in acid and ulcer healing. Finally, the tale of H pylori emerges as the basis for peptic ulcer disease, and the many of us from previous generations who were skeptics have become convinced. We owe a great tribute and should pay homage to the giants of medicine who showed us the way.

Pharmacy Time Capsules

Third Quarter 2014 1939 - Seventy-five Years ago: 1989 - Twenty-five Years ago: • The conservative Heritage Foundation published • The first Blue Shield plan was begun as an insurance to cover physicians’ fees.

“Assuring Affordable Health Care for All Americans,” which called for a mandate to 1914 - One hundred Years ago: purchase health insurance.

• Losec (omeprazole) was first marketed in U.S. by • Cocaine, used in many patent medicines and tonics, was widely available in pharmacies and Astra. In 1990, FDA required name change to other retail establishments until banned in 1914.

Prilosec to avoid confusion with Lasix.

1964 - Fifty Years ago: • Keflin (cephalothin sodium, Lilly) was the first cephalosporin to be marketed in the Unites States.

• Average cost of prescription was $3.41

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.

Fall 2014 • Arizona Journal of Pharmacy • 13

CASE REPORT: Breathalyzers + Inhalers = the Potential for False-Positives

By Alina Kurita PharmD Candidate 2015, Amanda Huels PharmD BCPS, Amy Leung PharmD BCPS Description: EB is a 64 year old white male who called to inquire if any of his medications would contribute to a false positive on his breathalyzer test. A veteran recently charged with driving under the influence with current probation requirement of random breathalyzer home tests. Prior to breathalyzer, the veteran uses his albuterol to allow for optimal exhalation and to prevent shortness of breath.

Past Medical History: Asthma, Hyperlipidemia, Seizures, Hypertension, Fatty Liver Disease, Chronic Obstructive Lung Disease Active Medications: Ergocalciferol 50,000 units Lisinopril 40mg Meloxicam 15mg Doxazosin Mesylate2mg Divalproex 250mg & 500mg Primidone 250mg Budesonide/Fomoterol 160/4.5mcg Albuterol 90mcg Sildenafil Citrate100mg Tiotropium Bromide 18mcg Aspirin EC 325mg Ibuprofen 800mg The breathalyzer is one of the most commonly used tools in detecting the level of alcohol consumed; however, it has been proposed that metered dose inhalers (MDIs) can potentially elevate the alcohol levels in the lungs thus resulting in a false positive test. The rationale behind this is that the alcohol content in MDIs is high enough to be detected by a breathalyzer. The minimum registered value that can be detected by a breathalyzer is as low as 0.02% which is equivalent to 0.02g/dL of alcohol (210L breath). Arizona law abides by the zero tolerance policy, so driving under the influence (DUI)citation are given as long the breathalzyer gets any positive reading (confirmed with a blood alcohol lab). Breath alcohol concentration (BrAC) less than 0.08% is considered to be the legal limit to drive; however, in the case that you are pulled over and any level of EtOH is detected, then a DUI may be issued.

There are many type of breathalyzers that detect alcohol in different ways. For example, one may measure the amount of alcohol by the intensity of electrical current from the oxidation of alcohol into acetic acid. Another may use infrared spectroscopy to FEATURES

detect alcohol, and others still might use scalar color changes from chemical reaction with alcohol and silver nitrate. While these tools are very reliable, they cannot distinguish between different types of alcohol and this is where the potential problem arises. The role of alcohol in inhalation medications is to solubilize the surfactant to allow better penetration of the medication into the lungs. The amount of alcohol in the medication is not enough to have systemic effects and will only act locally where it is inoculated. In December 2008, the utilization of inhalers containing chlorofluorocarbons (CFCs) were mandated to be phased out due to an international agreement called the Montreal Protocol on Substances that Deplete the Ozone Layer. The agreement included the transition of CFC propelled inhalers to hydrofluoroalkane (HFA) - propelled inhalers. Not all HFA MDIs have an alcohol component. The next page includes a table of inhalers that contain or do not contain alcohol. For example, EB Albuterol HFA inhaler does contain alcohol propellants but Budesonide/Formoterol HFA inhaler does not.

There are various websites containing information on how medications such as inhalers, cough syrup, and cold sore gels can cause false positive breathalyzer results.

However, these websites may lack sufficient evidence or references; this can cause misunderstandings. Despite the conversion to HFA inhalers after 2008, there have not been any new studies examining this phenomenon; however, there are older studies that have looked at this association of alcohol-containing inhalers and false positives. For the purpose of this summary, study results presented were converted to g/dL to allow for comparison to levels previously mentioned as detectable on a breathalyzer test.

One study conducted by Ignacio-Garcia et al. examined 69 patients to further understand this relationship. The study compared alcohol-containing MDIs to alcohol-free MDIs and to dry powder inhalers. The patient population ranged from 14-65 years old with clinically stable asthma and who were currently using one of the study inhalers on a regular basis. All patients took 1-2 inhalations of each studied inhaler and breathalyzer test measurements were taken at 1 minute and 5 minutes after inhalation. All participants had a confirmed negative breathalyzer test at baseline. The results showed that the Advair Diskus had no sign of alcohol at either minute 1 or minute 5 after inhalation, however 90% of MDIs tested positive or had invalid results after 1 minute. At 5 minutes, all test subjects were registering negative results on the breathalyzer. An issue with the study is the investigators combined both MDI groups and did not differentiate if the positives were from one or both groups.

CASE REPORT Another study by Barry and O’Callaghan observed 10 adults ranging from 24 to 36 years old using salbutamol (Airomir). This was conducted on 3 separate days and all patients were required to take 2 inhalations and to either use good technique (actuating inhaler at beginning of inhalation), poor technique (actuating inhaler after inhalation), or an AeroChamber on each respective day.

Measurements were taken before initial inhalation, after inhalation, at 2 minutes after, and at 5 minutes after. The results showed that there was an immediate increase in alcohol levels after inhalation in all three techniques; however, poor technique had the greatest increase overall, with a mean (range) increase from baseline to immediately after the inhalation of 0.073g/dL (0.0480.102). The good inhaler technique had a mean (range) increase of 0.038g/dL (0.015-0.054) and the aerochamber technique had a mean (range) of 0.023g/dL (0.01-0.04).

The majority of the patients had alcohol-free levels at 2 or 5 minutes after inhalation. One additional study that looked at this relationship was conducted by Bruce et al. to compare HFA-MDI to CFC-MDI and placebo-MDI. They also observed the effects of alcohol consumption as well.

Thirty-one patients were recruited for this double-blind study. Patients were grouped as either asthmatics or to the normal control group. Measurements were taken by using a breathalyzer prior and after the first dose at 2 minutes, 5 minutes, and 15 minutes after inhalation with all of the inhalers used in the study in a random order. These measurements were taken similarly after alcohol consumption separate from the inhaler use. The results showed that HFA inhalers had a detectable level in alcohol concentration in both asthmatics and the normal control after the first inhalation, 0.004 to 0.029g/dL (P = 0.0001) and 0.002 to 0.033 g/dL (P = 0.002), respectively.

These results were statistically significant for both groups; however the measurements at 5 minutes showed

negligible amounts of alcohol.

One of the manufacturers, Boehringer Ingelheim Pharmaceuticals conducted their own trials to observe the effect of alcohol content in Atrovent HFA on breathalyzer results. This was an open-label, randomized clinical trial of 20 patients who took 1, 2, and 4 inhalations at a time, with each inhalation containing 15.6mg of alcohol. Following each sequence of inhalation, they measured both the detection of alcohol in the patient’s expiratory breath and duration of effect. For all the inhalation sequences, there was a rapid increase up until 30 seconds before quickly falling.

Mean duration of detected alcohol was directly related with dose/number of inhalations. The mean duration of detected alcohol in the expiratory breath was 5.1 +/- 1.5 minutes, 8.3 +/- 1.9 minutes, and 13.5 +/- 1.2 minutes with 1, 2, and 4 inhalations respectively.

It can be concluded that there is a plausible relationship between MDI use and breathalyzer results, however further research is required to better solidify this information. The take-home point is that there is the possibility of someone testing falsely positive for alcohol if utilization of a HFA MDI inhaler occurred prior to testing. However, this spike in alcohol level only occurs immediately after inhalation and this duration does not last more than a few minutes. Unfortunately, one of the greatest limitations in referring to these past studies is that medication formulations do change from time to time. And so as clinicians, it is important to realize that inhaler selection can ultimately affect results and understand the significance of that. For example, for our veteran EB, his vehicle contained a court-mandated computer device called the Interlock that required a negative BrAC level before permitting the driver to start the ignition. If the computer detects alcohol, it will lock his car and not allow him to drive. This then gets reported

Contains alcohol (+)

Does NOT contain alcohol (-)

Alvesco® (Ciclesonide)

Advair® (Fluticasone Propionate/Salmeterol Xinafoate)

Atrovent®(Ipratropium Bromide)

Flovent® (Fluticasone Propionate)

Dulera® (Mometasone Furoate/Formoterol Fumarate)

Symbicort® (Budesonide/Formoterol)

ProAir® (Albuterol Sulfate)

Ventolin® (Albuterol Sulfate)

Proventil® (Albuterol Sulfate) Qvar® (Beclomethasone Dipropionate) Xopenex® (Levalbuterol Hydrochloride)

*Reference from drug package inserts for the following: Advair®, Alvesco®, Atrovent®, Dulera®, Flovent®, ProAir®, Proventil®, Qvar®, Symbicort®, Ventolin®, and Xopenex

FEATURES

Fall 2014 • Arizona Journal of Pharmacy • 15

CASE REPORT to the central office to alert them that there was an attempt in trying to drive under the influence. These results can have not only social but also more pressingly legal ramifications.

Therefore, it is important to understand how to accurately assess these screening tests for substance use, including what factors can potentially impact the results. The current interlock minimum detection level for the state of Arizona is at 0.03% (0.03g/dL) and will potentially decrease the minimum detection level to 0.025% (0.025g/dL) in the future.

Patients who are concerned about having a false positive breathalyzer test due to the recent utilization of an inhaler, can do one of the following. One, they can ask to opt for a blood alcohol test or two, they can ask to wait 15-20 minutes before taking the breathalyzer after inhaler utilization. While this may not be a relevant counseling point for all patients, it may be one that makes an impact in a patient’s life above and beyond better breathing.

References: 1. Ignacio-García JM, Almenara-Barrios J, et al. A comparison of standard inhalers for asthma with and without alcohol as the propellant on the measurement of alcohol in breath.

J Aerosol Med 2005; 18(1):193–197.

2. Barry PW, O’Callaghan C. New formulation metered dose inhaler increase breath alcohol levels.

Respir Med. 1999; 93:167-8.

3. Bruce C, Chan HP, Mueller L, et al. Effect of hydrofluoroalkane-alcohol inhalers on estimated alcohol levels in asthmatic subjects. Respirology. 2009 Jan; 14(1):112-6.

4. Boehringer Ingelheim Pharmaceuticals, Inc Medical Information Atrovent HFA. 2014.

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Risk of Serotonin Syndrome with Concomitant Use of SSRI/SNRI and Triptans

By Lisa Goldstone, MS, PharmD, BCPS, BCPP, Assistant Professor at University of Arizona College of Pharmacy, University of Arizona Medical Center - South Campus, & Wendy M. Gabriel, PharmD, BCPS, University of Arizona College of Pharmacy, University of Arizona Medical Center - University Campus Serotonin syndrome is an adverse drug reaction that occurs when a medication, a combination of medications, or other substances (e.g. cocaine) increase serotonin levels in the body.1 Increased stimulation of the serotonin receptors, specifically 5-HT2A, cause neuromuscular dysfunction and autonomic hyperactivity.1,2 Classic symptoms of serotonin syndrome are tremor, clonus, hyper-reflexia, agitation, diaphoresis, tachycardia and muscular rigidity.3 These symptoms may progress to life threatening events such as seizures, rhabdomyolysis, renal failure or disseminated intravascular coagulation.3 The incidence of serotonin syndrome has been rising since it was first described in several studies investigating high dose and combination serotonergic medication use in the 1960s.4 This rise could be due to the increasing number of serotonergic agents available to patients and better recognition and reporting by healthcare professionals.5 Increased stimulation of serotonin receptors can be caused by several mechanisms including decreased serotonin uptake or metabolism, increased serotonin synthesis or release, and direct activation of serotonin receptors.5 Medications implicated in serotonin syndrome include but are not limited to selective serotonin reuptake inhibitors (SSRI), tricyclic antidepressants (TCA), serotonin-norepinephrine reuptake inhibitors (SNRI), monoamine oxidase inhibitors (MAOI), triptans, St. John’s Wort and opioids.1 Illicit substances such as amphetamines, cocaine, and ecstasy (MDMA), can also potentially cause serotonin syndrome.6-8 Table 1 includes a list of medications and illicit substances associated with serotonin syndrome.5-9 Most case reports of serotonin syndrome have occurred in patients who received multiple serotonergic agents or had exposure to one agent for an extended period of time.5 In addition, medications and disease states that decrease cytochrome P450 enzyme activity, specifically 2D6 and 3A4, may cause higher serotonin levels than expected at normal therapeutic doses due to slower metabolism of medications processed by these particular enzymes.3,5 This is important as many serotonergic antidepressants are metabolized by one or both of these enzymes and some antidepressants, most notably fluoxetine and paroxetine, are potent inhibitors of either 2D6 and/or 3A4.10 In 2006, the FDA released an alert that use of triptans in combination with SSRI/SNRI may lead to “potentially life-threatening serotonin syndrome.”11 The FDA recommends that patients treated with both agents be informed of the possibility of serotonin syndrome and carefully monitored. This alert was based on biological FEATURES

plausibility and twenty-seven case reports of serotonin syndrome reported to the FDA. Since the alert, warning labels have been added to the products and the interaction has been classified as severe in most medication interaction software.12 By labeling the interaction as severe, this can potentially lead to under treatment of either depression or migraine which are two disease states that commonly coexist in patients.12,13 It is estimated that in 2007 and 2008, 1.3 million patients in the United States were prescribed both triptans and either an SSRI or SNRI.14 Prior to the FDA warning, two studies looked at adverse reactions for patients taking both antidepressants and sumatriptan. Blier et al. published a study in 1994 that followed fourteen patients over one year to determine if certain triptans were safe to administer to patients on serotonergic medications.13 Twelve patients were on one serotonergic medication and two patients were on two serotonergic medications.

Medications included fluoxetine, fluvoxamine, sertraline, moclobemide, lithium and buspirone. The article did not mention specific medication doses, however the author commented that in ten of fourteen patients, the antidepressant dose was higher than the minimal recommended dose. Patients were treated for a cumulative of 103 migraines during the study with sumatriptan 100 mg. Patients did not take more than 100 mg of sumatriptan per day. Serotonin syndrome or symptoms associated with serotonin syndrome was not reported by patients or study investigators. In 1999, Putnam et al. looked at medication interactions with subcutaneous sumatriptan administration in 12,339 patients.15 Study protocol allowed up to two 6 mg injections one hour apart, however the authors did not disclose the average dose of sumatriptan per day.

Twenty-nine percent of the patients were on an SSRI, TCA, MAOI or bupropion. There was no increase incidence of adverse medication events in these patients within 24 hours of sumatriptan administration.

The authors did not comment on the dose of antidepressants used in the study.

The two reasons cited by the FDA in support of the 2006 alert are biological plausibility and twenty seven case reports.11 However, due to the selectivity of the triptans for specific serotonin receptors as well as differing profiles among the triptans, biological plausibility seems less likely. Serotonin syndrome is thought to be due to activation of 5-HT1A and 5-HT2A receptors.1,16 Triptans are highly selective for the Fall 2014 • Arizona Journal of Pharmacy • 17

RISK OF SEROTONIN SYNDROME 5-HT1B and 5-HT1D receptors, with little activity on 5-HT1A.1,16 Because triptans are not active at the 5-HT2A serotonin receptors that are thought to be most responsible for serotonin syndrome, it cannot be assumed that they can cause serotonin syndrome based on their mechanism of action.1,16 In addition to minor activity at the 5-HT1A and no activity at the 5-HT2A receptors, sumatriptan has very low CNS penetration as measured in murine models.1,16 However, sumatriptan may increase serotonin via an indirect method. A murine study conducted in 2003 showed that after 21 days of sumatriptan administration, there was a significant increase in serotonin synthesis.17 The exact mechanism is unknown, but could be due to down-regulation or desensitization of 5-HT1 receptors that signal to the body that more serotonin is needed. Newer triptans, such as eletriptan, naratriptan, rizatriptan and zolmitriptan, have a slightly different pharmacokinetic and pharmacodynamic profile from sumatriptan. They are more lipophilic and have a higher specificity for the 5-HT1D receptor.18 Increased lipophilicity allows the medication to cross the blood brain barrier more effectively and thus lower doses provide therapeutic levels in the central nervous system. Decreased affinity for 5-HT1B, in addition to reduced dosing requirements, lessens the risk of coronary vasoconstriction commonly seen with less lipophilic and less specific agents such as sumatriptan (17). However, similar to sumatriptan, these agents have little activity at the 5-HT1-A and 5-HT1-B receptors that are responsible for serotonin syndrome. No literature exists stating that more lipophilic triptans have more or less risk of serotonin syndrome when compared to sumatriptan.

Evans et al. analyzed the 27 case reports referred to in the 2006 FDA alert to determine if each one met the Sternbach and/or Hunter criteria for serotonin syndrome.1 Because there is no laboratory test for serotonin syndrome, specific criteria are used to assist in accurate diagnosis. The first is the Sternbach criteria.4 It requires that there is no other cause for the syndrome, no recent addition or dosage increase of a neuroleptic agent, presence of a recent addition or dosage increase of a serotonergic agent, and presence of at least three symptoms of serotonin excess.4,19 These symptoms include mental status change, agitation, myoclonus, hyper-reflexia, diaphoresis, shivering, tremor, diarrhea, incoordination and fever. The Hunter criteria is a newer tool that is more sensitive (84%) and specific (97%) than the Sternbach criteria.1,19 The Hunter criteria require that one set of symptoms exist in the presence of a serotonergic medication.19 The symptom sets are: spontaneous clonus alone; inducible clonus and agitation or diaphoresis; ocular clonus and agitation or diaphoresis; tremor and hyper-reflexia; hyper-tonicity and temperature > 38째C; and ocular clonus or inducible clonus. Only seven of the 27 case reports met FEATURES

the Sternbach criteria and zero met the Hunter criteria.1 No case met both the Sternbach and Hunter criteria. Only eight of the case reports were published and the remainder were submitted through the MedWatch reporting system. Three were submitted by pharmaceutical representatives using second hand and vague information and many of the cases did not have enough information included to use either criteria fully.

Heavily based on the above paper, the American Headache Society released a position paper in 2010 stating that there was insufficient evidence to determine if there is an increased risk of serotonin syndrome when SSRIs/SNRIs are used in combination with triptans.2 A rebuttal letter to the editor from the FDA-Center for Drug Evaluation and Research commented that there are now 60 reported cases of serotonin syndrome associated with SSRI/SNRI and triptans.20 The author explained that they do not use the Hunter criteria because it has not been validated and that the Sternbach criteria do not have the sensitivity for evaluating post marketing safety reporting.

The author acknowledged the existence of reporting bias and incomplete information in most reports.

There is inconclusive evidence that use of SSRIs or SNRIs in combination with triptans at recommended doses cause serotonin syndrome at an incidence high enough to merit such a warning from the FDA. The evidence supporting and refuting the incidence is of low quality. It is possible that serotonin syndrome is under-reported to the FDA and there is still uncertainty if case reports cited by the FDA are actually serotonin syndrome caused by triptans used with SSRI/SNRI. Furthermore, many of the case reports complete with medication doses report unusual dosing.1 For example, several patients were taking scheduled triptans daily, high doses of antidepressants (venlafaxine 300 mg daily or citalopram 60 mg daily), or multiple serotonergic agents during intentional overdose.1 At this time, the use of triptans in patients receiving SSRI or SNRIs may be appropriate when the benefit outweighs the risk. While serotonin syndrome is a very serious adverse drug event, the overall incidence in the population is very low with only 60 cases reported to the FDA while approximately 1.3 million Americans have been prescribed both medications.14,20 Incidence of linezolid associated serotonin syndrome was estimated to be 0.24% in one large review, which is much larger.21 To reduce the risk of serotonin syndrome when a SSRI or SNRI is used concomitantly with a triptan, doses of both agents should remain within FDA approved parameters and additional serotonergic agents should be avoided when at all possible. Although the likelihood of developing serotonin syndrome with this combination is rare, patients should always be educated on the signs and symptoms of serotonin syndrome and how to properly administer their triptan as overuse could increase the chance of developing serotonin syndrome.

RISK OF SEROTONIN SYNDROME Table 1: Medications Associated with Serotonin Syndrome5-9 Buspirone Meperidine Carbamazepine Methadone Chlorpheniramine Methamphetamine Cocaine Metoclopramide Codeine Nefazodone Cyclobenzaprine Ondansetron Dextroamphetamine Reserpine Dextromethorphan Ritonavir "Ecstasy" Selegiline Ergot alkaloids Sibutramine Fentanyl SNRI Ginseng SSRI Granisetron TCA Levodopa Tramadol Linezolid Trazodone Lithium Triptans MAO Inhibitors Valproic acid Ecstasy=3,4-methylenedioxymethamphetamine; MAO=monoamine oxidase; SNRI=serotonin-norepinephrine reuptake inhibitors; SSRI=selective serotonin reuptake inhibitor; TCA=tricyclic antidepressants

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References 1. Evans RW. The FDA alert on serotonin syndrome with combined use of SSRIs or SNRIs and triptans: an analysis of the 29 case reports. MedGenMed 2007; 9(3): 48.

2. Evans RW, Tepper SJ, Shapiro RE, et al. The FDA alert on serotonin syndrome with use of triptans combined with selective serotonin reuptake inhibitors or selective serotonin-norepinephrine reuptake inhibitors: American headache society position paper.

Headache 2010: 1089-99.

3. Woytowish MR, Maynor LM. Clinical relevance of linezolid-associated serotonin toxicity. Ann Pharmacother 2013; 47: 388-97.

4. Sternbach H. The serotonin syndrome. Am J Psychiatry 1991; 148: 705-13.

5. Ables AZ, NAgubilli R. Prevention, diagnosis, and management of serotonin syndrome. Am Fam Physician 2010; 81(9): 1139-42.

6. Parrott AC. Recreational ecstasy/MDMA, the serotonin syndrome, and serotonergic neurotoxicity. Pharmacol Biochem Behav.

2002;71:837-44.

7. Mugele J, Nanagas KA, Tormoehlen LM. Serotonin syndrome associated with MDPV use: a case report. Ann Emerg Med. 2012;60(1):100-2.

8. Malik HU, Kumar K. Serotonin syndrome with escitalopram and concomitant use of cocaine: a case report. Clin Med Insights Case Rep. 2012;5:81-5.

9. Bienvenu OJ, Neufeld KJ, Needham DM. Treatment of four psychiatric emergencies in the intensive care unit. Crit Care Med 2012; 40: 2662-70.

10. Spina E, Santoro V, D’Arrigo. Clinical relevant pharmacokinetic drug interactions with second-generation antidepressants: an update. Clin Ther. 2008;30:1206-27.

11. Food and Drug Administration Web site. http://www.fda. gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm085845.htm. Accessed March 5, 2014.

12. Kogut SJ. Do triptan antimigraine medications interact with SSRI/SNRI antidepressants? What does your decision support system say? JMCP 2011; 17(7): 547-50.

13. Blier P, Bergeron R. The safety of concomitant use of sumatriptan and antidepressant treatments. J Clin Psychopharmacol 1995; 15: 106-9.

14. Putnam GP, O’Quinn S, Bolden-Watson CP, et al. Migraine polypharmacy and the tolerability of sumatriptan: A large-scale, prospective study. Cephalalgia 1999; 19: 668-75.

15. Sclar DA, Robison LM, Castillo LV, et al. Concomitant use of triptan, and SSRI or SNRI after the US food and drug administration alert on serotonin syndrome. Headache 2012; 52: 198-203.

16. Gillman PK. Triptans, serotonin agonists, and serotonin syndrome (serotonin toxicity): A Review. Headache 2010; 50: 264-72.

17. Dobson CF, Tohyama Y, Diksic M, Hamel E. Effects of acute or chronic administration of anti-migraine drugs sumatriptan and zolmitriptan on serotonin synthesis in the rat brain.

Cephalalgia 2004; 24: 2-11.

18. Millson DS, Tepper SJ, Rapoport AM. Migraine pharmacotherapy with oral triptans: a rational approach to clinical management.

Expert Opin Pharmacother 2000; 1(3): 391-404.

19. Dunkley EJC, Isbister GK, Sibbritt D, Dawson AH, Whyte IM. The Hunter serotonin toxicity criteria: simple and accurate diagnostic decision rules for serotonin toxicity. Q J Med 2003; 96: 635-42.

20. Fine A, Bastings E. Triptans and serotonin syndrome [letters to the editor]. Headache 2012; 52(7): 1184-5.

21. Butterfield JM, Lawrence KR, Reisman A, Huang DB, Thompson CA, Lodise TP. Comparison of serotonin toxicity with concomitant use of either linezolid or comparators and serotonergic agents: an analysis of Phase III and IV randomized clinical trial data.

J Antimicrob Chemother 2012; 67: 494-502.

Fall 2014 • Arizona Journal of Pharmacy • 19

An Expert Roundtable on Continuous Quality Assurance in Pharmacy

By Jill Augustine, PharmD, MPH, PhD Student, University of Arizona College of Pharmacy Patrick Campbell, PharmD Candidate Class of 2014, University of Arizona College of Pharmacy Terri Warholak, RPh, PhD, Associate Professor, University of Arizona College of Pharmacy Ken Baker, B.S.Pharm, JD, Of Counsel / Pharmacy Consultant, Renaud Cook Drury Mesaros, PA Andrea Bishop, PhD, Postdoctoral Fellow, St. Mary’s University Department of Psychology Todd A. Boyle, PhD, Associate Professor, St. Francis Xavier University Gerald Schwartz School of Business David Nau, PhD, RPh, CPHQ, FAPhA, President, Pharmacy Quality Solutions, Inc. Neil J. MacKinnon, BSc(Pharm), MSc(Pharm), PhD, Dean, University of Cincinnati James L Winkle College of Pharmacy Panel Members: Ken Baker (KB) is the founder of Ken Baker Consulting, a company that is dedicated to assisting pharmacists from across the country in reducing medication errors.

Additionally, he is the attorney of counsel for Renaud Cook Drury Mesaros (PA) and a consultant for Pharmacists Mutual Insurance Company. He is a national expert of pharmacy litigation and has experience with pharmacy regulation, risk management, insurance and pharmacy quality programs, continuous quality improvement (CQI), and reduction of compounding and medical errors.

Andrea Bishop (AB), Ph.D., is a Postdoctoral Fellow in the Department of Psychology at Saint Mary’s University in the fields of organizational safety culture and patient safety.

Todd Boyle (TB), Ph.D., is an Associate Professor of Operations Management and the Canada Research Chair in Quality Assurance in Community Pharmacy at St. Francis Xavier University. He is also the lead investigator of the SafetyNET-Rx quality improvement initiative for community pharmacies in Canada. His research focuses on the determinants of quality related event (QRE) (i.e. medication error and near miss) reporting and learning in community pharmacies, and how CQI programs can help to enhance QRE reporting and learning activities.

Neil MacKinnon (NM), Ph.D., is the Dean of the University of Cincinnati College of Pharmacy. He was previously a Professor and Director for the Center for Rural Health at the University of Arizona Mel and Enid Zuckerman College of Public Health. His research has focused on improving the quality and safety of the medication-use system in both Canada and in the United States.

David Nau (DN), PhD, RPh, CPHQ, FAPhA, is the President of Pharmacy Quality Solutions, a joint venture of the Pharmacy Quality Alliance (PQA) and CECity. His work has focused on the improvement of medication-use within the healthcare system and has been recognized by several organizations for his leadership in the field of quality improvement for pharmacy services. He is one of the few pharmacists to hold the designation of Certified Professional in Healthcare Quality (CPHQ).

Terri Warholak (TW), RPh, PhD, is an Associate Professor at the University of Arizona College of Pharmacy. Her work has FEATURES

focused on reducing medication errors in the healthcare system, the use and development of health information technology, and bringing pharmaceutical care to underserved populations.

Goal Statement: This article was developed to discuss the benefits, implementation, and maintenance of a continuous quality assurance (CQA) or continuous quality improvement (CQI) program.

Background: The concept of quality as an integral component of healthcare has become increasingly more popular with the onset of healthcare reform. Medicare Star Rating Quality Measures and Accountable Care Organizations are two examples of current monetary incentives surrounding quality healthcare. These programs primarily assess quality on a macro scale but the ideals of these programs should resonate with individual healthcare professionals and be an impetus to change in practice settings. In the realm of pharmacy, one method of ensuring improved patient care is through the utilization of a Continuous Quality Assurance (CQA) program. The Arizona legislature defines a CQA Program as a planned process designed by a pharmacy permittee to identify, evaluate, and prevent medication errors. Since the CQA process is a continuous cycle of improvement, it has the potential to impact healthcare processes by: mitigating error frequency, enhancing workflow processes, and creating a culture of continual growth and development.

Subsequently, CQA programs may lead to enhanced quality of care for patients. Knowing these benefits, the Arizona legislature passed the Pharmacy Continuous Quality Assurance Law. This law requires community pharmacies to develop, utilize and maintain a CQA system.

Round Table Discussion: Neil MacKinnon (NM): We have gathered together a panel of North American experts on quality and safety in community pharmacy. This round table discussion will help Arizona pharmacists with issues about quality and safety, quality assurance, and how pharmacists can comply with regulations. The first question is for Ken Baker: What happens when a pharmacist has a CQA

EXPERT ROUNDTABLE system but errors still occur in his or her pharmacy?

Ken Baker (KB): Errors occur even with a well-implemented CQA system. A CQA system is one that reduces the risk of a second error occurring; it is not one that eliminates all errors. I do not care how good a CQA system a pharmacy has, how robust it is, there will be another error. When an error occurs, it is important to take a look at the system and answer the question: “How did the error occur?” In other words: what was the flaw in the system or what was missed or what steps or safeguards need to be added? So it is a way of learning from the system. That is why we call it continuous quality improvement (CQI) or continuous quality assurance (CQA) because the idea is to continuously improve. It is important for the pharmacist to be able to do is to show that an error occurred in spite of the fact that a CQI system is in place; in spite of the fact that the CQI system is used, an error still occurred. That becomes the best defense against possible litigation: I’ve got a CQA system, I use the CQA system, and I still had a mistake.

NM: Okay, you’ve talked about when a pharmacy has a CQA system, but what happens when a pharmacy does not have a formalized CQA system and an error occurs?

KB: Such a pharmacy is going to have errors. However, if a pharmacy does not have a CQA system, the problem is that the pharmacists and all involved (i.e., staff, technicians, owners) are now acting recklessly because there is no CQI system to help prevent errors. From the Board of Pharmacy perspective, they are probably going to discipline a pharmacy without a CQI system, where they may not discipline a pharmacy that was using a CQI system.

NM: Joining us as part of this roundtable discussion are two experts in CQA in community pharmacy from Nova Scotia, Canada. Nova Scotia has had similar regulations requiring the implementation of CQA in community pharmacies since 2010. My first question is for Dr. Andrea Bishop. In your opinion, what are the main challenges that pharmacists face in implementing CQA and how can these challenges be overcome?

Andrea Bishop (AB): One of the main key challenges is the lack of time for pharmacies to have a well-implemented CQA system. That includes medication error and near miss (i.e., errors that get caught before they get to the patient) reporting and those quality assurance activities related to the learning and sharing components as well. One of the practical things that we’ve seen people implement in Nova Scotia is to make sure to use the CQA system to improve the pharmacy work flow. SafetyNET-Rx, our CQA program, is a standardized program but it also allows pharmacists to tailor the program for each pharmacy. This includes using a hybrid approach to reporting quality related events or FEATURES

QREs (i.e., errors and near misses) where the pharmacist or pharmacy technician write down the QRE on paper as soon as it happens but then also taking the time or designating a student pharmacist to input the information into an online error reporting system for analysis.

Another challenge faced by pharmacies is when and where to discuss QREs. Most pharmacies have regularly scheduled staff meetings already; so many pharmacy managers include quality assurance activities in that meeting. The discussion does not necessarily need to be part of a formal staff meeting; it can also be done as part of informal conversations on a day-to-day basis. The key is to find opportunities throughout the day to make sure pharmacists and staff have those conversations. This also applies to addressing the peoples’ fear of error reporting. If I’m the pharmacist in charge, how can I make error reporting a more comfortable situation to discuss among my staff? Should I do it as an off-hand remark and start to get that conversation building that way, rather than gathering everyone around the table? The real question is “how do I make it my own?” In Nova Scotia, have seen those success stories. We were able to see some of those little things that people are trying to do to make this work.

NM: What could a pharmacist say to an employer who forces them to work fast and what can CQA do to help address problems with workflow?

David Nau (DN): I think that’s why it is important to collect data on an on-going basis. This allows for a pharmacist to know when and where errors are occurring. He/she can track prescription volume on certain days or in certain portions of the system and identify select times of the day when more errors may occur. So that way, after data analyses is completed, anyone can go back and say when there were certain times that “we saw an increase in the error rates and was it correlated with certain levels of volume or certain staffing configurations or a combination.” This can be the starting point to diagnosing how workload is, or is not, related to error rates in the pharmacy. In my opinion, this is why having data helps a pharmacist speak more intelligently on what is happing in his/her store.

Terri Warholak (TW): Additionally, one should review the published literature. The literature has provided ample evidence that having a heavier workload increases errors. In fact, it is a curvilinear relationship whereas at very low prescription volume errors increase. There seems to be a point where optimal flow is reached, then, once that point is exceed, the errors increase again. So, there are published studies in the literature to show that there is a point at which workFall 2014 • Arizona Journal of Pharmacy • 21

EXPERT ROUNDTABLE flow exceeds safety.

DN: I think that in the extreme of workloads, one tends to see extreme increases in error rates. It has been hypothesized that the very low ends of workload this type of increase in error rates is seen. It may be because of cognitively one may not be engaged and not “in the zone.” So when I have reviewed workload and error rates with pharmacies, I have noticed that Sundays seem to be time when workload got very low volume but higher error rates. So perhaps a pharmacist is not cognitively prepared and oriented for low volume. Or, as we found in one pharmacy, the pharmacist was distracted by watching football on Sundays because he thought that the store was so slow, he thought he could watch television and work. So there could be a number of reasons to explain how the low workload correlates to more errors. Plus, typically, on low volume days, fewer staff members are present. So it becomes a function of workload relative to staffing. I believe that there is published literature that has looked at prescription volume; it becomes complex when one starts to count the number of prescriptions and thinking about e-prescriptions or refills. If I remember correctly, once a pharmacy fills about 15 prescriptions per pharmacist per hour, there is an increased slope in the error rate.

KB: I take a little bit of a different view on that question.

I am not willing to let the pharmacist off the hook quite that easily. It is the pharmacist who is the professional.

It is the pharmacist who fills the prescription. It’s the pharmacist whose duty it is to care for the patient. If it is particularly busy one day and the pharmacy is understaffed, the pharmacist still has the obligation to fill only one prescription at a time. If there are 23 people in line waiting to be helped, this does not mean that the people in that line have any different expectations or any different needs than when there are two people who need assistance. I think the statement “The pharmacist must ensure that all prescriptions are filled within 20 minutes, as outlined by our promotions campaign” somewhat allows the pharmacists to take blame off of themselves for an error. The pharmacist is a professional who needs to ensure they take the appropriate amount of time to fill every prescription correctly. The greatest pressure is currently on the pharmacists and pharmacy technicians to reduce errors, yet correctly fill a particular number of prescriptions per day (or per hour). For this reason, an interesting aspect of the new Walgreens workflow design is that the company has tried to insulate the technicians from the pressure of waiting customers by having a patient pick-up their prescriptions out of visual sight of the technician so they can focus on filling the prescription.

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Todd Boyle (TB): In Canada, there have been pharmacy staff who have said, “Hey, look, it’s too busy, I have to stop, I need to take a break for a minute because if I do not, I am actually going to make an error.” Our CQA program included pharmacies that, through the data they collected, were able to pinpoint what days they are likely to have errors.

The pharmacies take this information to their corporate offices and use it to create a case for getting additional staff members on days more prone to errors.

DN: I think really it becomes a complex issue to try to build an administrative rule around volume like some states have attempted to do. Since there are so many factors when considering volume, it is not just a function on how many prescriptions are filled in a time period but how many staff were there, the personnel mix (how many pharmacists, how many technicians), the technology utilized, and if staff are getting periodic breaks. So if a pharmacist can refresh and take a break periodically, he/ she can probably handle a higher volume for a short time.

So I think that is where it becomes challenging to pick a number that is deemed to be too many for any pharmacy.

To impose that administratively without considering all the other factors that effect the relationship would be difficult.

NM: Todd, since there are differences in CQA regulation across Canada, just as in the US, what challenges are you seeing from pharmacy regulators who wish to implement legislation about CQA programs for community pharmacy?

TB: First of all, creating a common terminology for CQA and QREs needs to occur. Across Canada, one of the first things we wanted to do was to develop and use common terminology so we could send out messages to all pharmacies. There are not many pharmacies in Canada; there are approximately 8,200 community pharmacies in the entire country. Another area that Canadian regulators are struggling with is how to capture if system improvements are actually occurring in pharmacies. However, it is difficult for an inspector to know if pharmacists and technicians are really learning from errors. The struggle is how do you measure this learning? The pharmacy inspectors are telling us that they need to be trained in CQI. Another challenge in Canada, as well as in the United States, is that the role of regulatory authority is to protect the safety of the public, while the pharmacy advocacy bodies’ role is to protect the best interest of pharmacists. So, the pharmacy regulator may not necessarily be the pharmacists’ friend.

Currently, the regulators are struggling with their dual role where they promote talking about and reporting errors while simultaneously having to discipline unsafe practices.

NM: What about the United States regulatory environment and the trends from across the country towards the treatment of errors in pharmacies?

KB: I have seen a lack of uniformity in the United States.

I have not seen any uniformity across the states in how errors are examined from the board of pharmacies or what type of punishment should occur. I have seen from boards of pharmacy where one time, a board of pharmacy will consider a human error, where another time the board will punish the pharmacist or pharmacy, and another time the board will give a warning letter.

It is terribly inconsistent and, as a lawyer, it is terribly frustrating.

NM: One key part of CQA is data collection. How can pharmacies collect better data on errors and near misses?

TW: One key aspect is to ensure that everyone in the pharmacy understands: how to use the available data collection tools; the different categories of error; and how to categorize errors. For example, one of the systems we use in my quality improvement course is the Pharmacy Quality Commitment (PQC™) system and its peer review form, which documents the different types of errors and where the errors were caught. When I teach people how to use the system, I use an example error and have the learner state how he or she would record this example error on the peer review form. I am amazed each time I complete this activity because learners will categorize and record the same error differently. Those who use a CQA program need to know that common terminology is important before they begin. If everybody records an error differently, then researchers, managers, and those who use CQA programs are not going to get good data that can be utilized to improve systems. It is important to have all staff members trained at the outset to report similar errors in the same way to improve consistency.

Agreement on nomenclature and error coding is essential to produce data that are reliable and valid.

DN: So, is it also important to appropriately define a near miss and how it differs from a medication error?

Because I find there is a lot of uncertainty around these definitions.

TW: Absolutely. A near miss can be defined as an error that has occurred but was corrected before the medication was dispensed to the patient, as opposed to a medication error which reached the patient.

Additionally, the pharmacy needs to record where these errors originated: the physicians’ office; during prescription order entry; or elsewhere within the workflow.

TB: So if it originates in a physician’s office, it should be FEATURES

considered an error?

EXPERT ROUNDTABLE

TW: Absolutely!

KB: When considering how to categorize when an error was caught or when it was made, one of the areas to consider is if the mistake was the physician’s or the nurse’s. A few years ago, the PQC™ system developers added a category for doctor’s errors. This was done for a couple of reasons: first, because the category made the data more accurate, and secondly because the category allowed pharmacists to have evidence to show that pharmacists prevented these errors, as opposed to how many errors pharmacists make. This is important information to document and publish.

DN: The need for standardization goes beyond the individual pharmacy. If patient safety organizations are going to make good use of all the data being fed to them, standardization in how the information is coded is important. Currently, patient safety organizations (PSOs) are facing a challenge where individual pharmacies are providing error data, but each pharmacy has slightly different definitions and slightly different thresholds for what they consider reporting. The Pharmacy Quality Alliance (PQA) has tried to work with some PSOs to identify standard definitions. Standard categorization of medication errors and near misses is important in order to understand common issues and best practices. The challenge is to have some flexibility for pharmacies to focus on issues that they consider important. At least with a common nomenclature and a common set of definitions, communicating with pharmacies across the country becomes easier and allows pharmacies to compare “apples to apples.”

KB: The Agency for Healthcare Research & Quality (AHRQ) has created common formats that only partially work because they are for too big of an audience. So we almost need our own common format that is specific for pharmacy.

NM: Todd, based on your experiences in Canada, what benefits have you seen with the fact that all the errors and near misses are reported to the Institute for Safe Medication Practices (ISMP) Canada and then pharmacists can look at how they compare?

TB: Well standardization is important, so pharmacies should use the exact same form. However, the categorization of medication errors and near misses are still not consistent because it is unclear to pharmacists at what point a near miss should be considered a near miss. Before SafetyNET-Rx was initiated in Canada, there was no centralized database.

SafetyNET-Rx was able to partner with ISMP Canada to create the reporting database. ISMP Canada has done an excellent job of mining the data and sending safety Fall 2014 • Arizona Journal of Pharmacy • 23

EXPERT ROUNDTABLE bulletins so pharmacies can learn from these errors.

AB: I have found that when working with pharmacies (and pharmacists), it has been helpful to informally benchmark pharmacies against one another. Pharmacists can see the aggregate data from pharmacies similar size to theirs. This information sharing allows pharmacists to determine if the errors occurring in their pharmacy are also occurring in other pharmacies.

NM: So in conclusion, we have discussed medication error reporting systems in Canada and in Arizona. However, what does this mean for pharmacies and other health professions, since federal agencies and health care plans are starting to measure pharmacies on key performance indicators?

DN: I think it is important that pharmacies and pharmacists recognize that through the Medicare Part D programs medication use quality measures have been published. Currently, federal agencies (especially Centers for Medicare and Medicaid Services or CMS) are measuring quality measures for each medication plan. This is leading to plans to scrutinize their pharmacy network to determine how each pharmacy is individually performing on these quality measures and as an aggregate by chain or practice setting. Because there are financial implications for the plans, it has marketing and enrollment implications. Therefore, pharmacies need to know the evaluation measures that are being used by the plans and by the federal government. For the near future, I would anticipate there will not be public reporting on pharmacy quality around the star ratings. But in the long-term, I am very confident that public reporting will occur, as we have seen this change occur with other health professions.

Therefore, it is important for pharmacies to begin to research different PQA programs that are available in order to be prepared for these reporting requirements.

Ultimately there will be consumer groups that demand that information because they want to know which pharmacies have better performance or which are more helpful to patients. So I think we need to recognize that pharmacies are going to face increased transparency, so it is important to start assessing ourselves now before that occurs.

NM: There are resources available to community pharmacists who want to initiate or improve the monitoring and tracking of medication errors in their pharmacies. If you or your pharmacy would like more information, please contact Terri Warholak at Warholak@pharmacy.arizona.edu for assistance.

Summary FEATURES

CQA programs help to identify errors that occur during the medication dispensing process. The programs use data from errors and near misses (errors that were caught prior to reaching the patient) to identify and fix system weaknesses. Therefore, colleting data, analyzing data and improving systems are key elements of CQA. Pharmacies and pharmacy staff can use CQA programs to: prevent errors, analyze near misses, identify staffing needs, and compare their errors rates to similar pharmacies.

In addition to a well-implemented CQA program, pharmacy organizations, patient safety organizations, and regulatory authorities need to develop common language and definitions for identifying errors and collecting error data. A common language is important in order to understand systems issues and to establish best practices for reducing medication errors. This step is vital for developing standards, mining data, and preparing safety bulletins so all can learn from reported errors.

Call to Action Many pharmacies report medication errors to a national corporate reporting system or to their corporate organization. However, anecdotal evidence supports that community pharmacies do not track near miss errors.

A clear picture of the systems problems of a pharmacy cannot be gleaned without near-miss error tracking. In addition, it is essential for pharmacists at the store level to view their own store level error and near miss data and to hold periodic staff meetings to determine what system level changes are warranted. Often, the best people to fix a systems problem are the people who work in the system each day; the pharmacy staff are the best resource and should be used as such. Once blame is taken out of the equation the staff will be able to help fix the system and take ownership for quality. After system changes are made, data should again be collected (as is in keeping with a continuous process) to determine what worked and what changes still need to be made. These data can be presented to the board in case of inspection to show that a CQA process is taking place in the pharmacy and that everyone is engaged, as they should be.

Conflict of interest Statement: Ken Baker was part of the two-member team that initially developed Pharmacy Quality Commitment (PQC™).

Arizona Delegates Report on 66th Annual Session of the ASHP House of Delegates & Proceedings of ASHP Summer Meeting Prepared by: Mindy Throm Burnworth, PharmD, BCPS, FAzPA Approved by: Carol Rollins, MS, RD, PharmD, BCNSP, FAzPA, FASHP, FASPEN; and Sandra Leal, PharmD, MPH, FAPhA, CDE Mindy Throm Burnworth, Carol Rollins, and Sandra Leal served as the Arizona Delegates during this year’s American Society of Health-System Pharmacists (ASHP) House of Delegates (HOD) 66th Annual Session in Las Vegas, Nevada. Christi Jen served as Arizona’s Alternate Delegate.

Arizonians John Murphy and Phillip Schneider, Past ASHP Presidents, also served as Delegates.

The HOD is the authority over ASHP professional policies, which express the Society’s stance on important issues related to health-system pharmacy practice and medication use. The House meets annually at the ASHP Summer Meeting where it reviews policy proposals that have been approved by the Board of Directors. Most professional policies are initially proposed by ASHP members and then drafted by ASHP Councils or the Executive Committees of Sections and Forums.

The development of good policy takes time and benefits from active, constructive discussion. In early May 2014, the Arizona Delegates and Alternate Delegate attended the Regional Delegate Conference in Phoenix, AZ. During this conference, proposed changes to policies were discussed and then posted to ASHP Connect (ASHP’s online member communication tool). ASHP Connect allows individuals to connect with peers, discuss topics of interest, and share ideas and expertise. Expand your network and join the discussion at connect.ashp.org/ASHP/Home. Finally, the policies are voted on during the HOD session. Upon approval by the ASHP Board of Directors, the policies are official.

During the House meetings (June 1 and 3, 2014), the Arizona Delegates along with approximately 200 other Delegates collectively reviewed over 20 policy items, one statement, and updates to the ASHP bylaws. The Arizona Delegates wish to communicate the outcome of the policy process to you, our Arizona constituents. The 20 new ASHP policies (including policies on Standardization of Oral Liquid Medication Concentrations; Federal and State Regulation of Compounding; State Prescription Drug Monitoring; Access

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to Oral Contraceptives Through an Intermediate Category of Drug Products; Credentialing, Privileging, and Competency Assessment; Documentation of Patient-Care Services in the Permanent Health Record; and many others), one new ASHP statement, and changes to ASHP Bylaws and House of Delegates Procedures are available online at: ashp.org/DocLibrary/ Policy/HOD/HOD2014Policies.aspx Alternatively, these will be published in an upcoming issue of the American Journal of Health-System Pharmacists.

Other documents including the Report of the President and Inaugural Address of the Incoming President are available at ASHP’s official HOD website: ashp.org/menu/PracticePolicy/HOD.aspx Check this website often for important policy updates.

Forty new recommendations were made by members of the HOD and will serve as agenda items for the 2014-2015 policy year. The recommendations are available at: ashp.org/DocLibrary/Policy/HOD/HODRecommendations.aspx . One of the recommendations (Safe Use of Drug-Containing Devices and Diagnostic Agents) was brought forth by the Arizona delegation. All recommendations will be referred to an appropriate Council.

In addition to the House proceedings, several Arizona pharmacists received special recognition at the ASHP Summer Meeting. Carol J. Rollins, PharmD, MS, BCNSP, The University of Arizona Medical Center, Tucson, AZ and Mitchell S. Buckley, PharmD, FCCM, BCPS, Banner Good Samaritan Medical Center Department of Pharmacy, Phoenix, AZ were given the title “Fellow” by the ASHP in recognition of the excellence they have achieved in pharmacy practice.

Members who have achieved FASHP status have successfully demonstrated sustained commitment or contributions to excellence in practice for at least 10 years, contributed to the total body of knowledge in the field, demonstrated active involvement and leadership

Fall 2014 • Arizona Journal of Pharmacy • 25

in ASHP and other professional organizations, and have been actively involved in and committed to educating practitioners and others.

John E. Murphy, PharmD, FASHP, FCCP, a pioneer in the field of clinical pharmacokinetics and noted pharmacy educator, was the recipient of the ASHP’s 2014 Harvey A.K. Whitney Lecture Award. The Whitney Lecture Award recognizes individuals who have made outstanding contributions to health-system pharmacy and is considered the most prestigious honor bestowed in health-system pharmacy. ASHP has administered the Award, established in 1950 by the Southeastern Michigan Society of Hospital Pharmacists, since 1963. Harvey A. K. Whitney, ASHP’s first president, was an editor, author, educator, practitioner, and leader in hospital pharmacy. Nominations for the award are made by past recipients and ASHP members. The winner is selected by a majority vote of past honorees.

ASHP introduced a new logo and tagline at the opening session of the Summer Meeting. The new logo represents ASHP as a strong, forward-thinking organization focused on helping members improve patient care and advance pharmacy practice. The new tagline, “Pharmacists Advancing Healthcare” points to pharmacists’ key roles in patient care. ASHP will be phasing in use of the new logo and tagline over the next several months.

The wait is over! Legislation is now in the House of Representatives that allow pharmacists to take the most significant step towards provider status in nearly two decades. H.R. 4190 is bipartisan legislation that will amend the Social Security Act to recognize pharmacists as providers under Medicare Part B.

The legislation will recognize licensed pharmacists working within their state pharmacy practice acts to deliver care for patients in federally defined medically underserved communities.

This change will help address gaps in our nation’s health care system by increasing access to pharmacists’ services in all ambulatory settings including clinics and office practices in hospitals and health systems for Medicare patients who live in medically underserved communities. As a pharmacist and a constituent, you have tremendous influence with your members of Congress. And as ASHP and the profession work to build support for H.R. 4190, it is more important than ever for you to reach out to your elected officials so that they understand how provider recognition will improve patient care for some of our nation’s most vulnerable patients. As of July 18, 2014 the bill has 71 co-sponsors.

We need your helping contacting the Arizona representatives! Join ASHP’s Provider Status team at ashp.org/providerstatusteam Make a donation to ASHP’s PAC (Political Action Committee) at ashp.org/pacdonate Thank you for electing us to represent Arizona during the 66th Annual Session of the ASHP HOD. Your voice is important to the profession especially to advance pharmacists as health care providers! Your feedback is encouraged. Contact: Mindy Throm Burnworth mburnw@midwestern.edu, Carol Rollins Carol.Rollins@uahealth.com, Sandra Leal SandraL@elrio.org or Christi Jen Christi.Jen@bannerhealth.com

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DRUG INFORMATION QUESTION How does triamcinolone acetonide nasal spray (Nasacort®) compare to fluticasone propionate (Flonase®) for the treatment of allergic rhinitis?

By Christopher Barnett, Pharm.D. Candidate, and Stacy L. Haber, Pharm.D., Associate Professor, Midwestern University College of Pharmacy-Glendale

Answer: Introduction Allergic rhinitis is characterized by nasal congestion, rhinorrhea, sneezing, and/or itching associated with triggers such as dust mites, mold, or seasonal allergens. It affects up to 30% of adults and 40% of children in the United States and causes significant costs in terms of lost days at work and school.1 Intranasal steroids are recommended as the most effective therapy for allergic rhinitis by the 2008 American Academy of Allergy, Asthma & Immunology and American College of Allergy, Asthma & Immunology (AAAAI/ ACAAI) and World Health Organization (WHO) guidelines.1,2 In the United States, there are currently 7 intranasal steroids available in various formulations: fluticasone (Flonase®, Veramyst®), beclomethasone (Beconase®, Qnasl™), mometasone (Nasonex®), flunisolide, triamcinolone (Nasacort® AQ), ciclesonide (Omnaris®, Zetonna™), and budesonide (Rhinocort® Aqua®).3 Intranasal steroids work through local anti-inflammatory and vasoconstrictor properties.3-7 These agents are approved for the treatment of perennial or seasonal allergic rhinitis. Fluticasone propionate is the most commonly dispensed agent, ranked at #20 of the top 200 prescribed medications in 2012.8 Several studies have attempted to rank intranasal steroids based on their topical strength; fluticasone is considered the most potent while triamcinolone is considered the least potent.5-7 In July of 2013, an FDA panel voted in favor of approving triamcinolone acetonide nasal spray (Nasacort®) for a switch from prescription-only to over-the-counter (OTC) status.9 It was approved in October of 2013 and became available in February of 2014.10,11 A search of Medline found 3 randomized controlled trials which included multiple evaluations of the safety and efficacy of intranasal triamcinolone compared with intranasal fluticasone.4-6 Clinical Trials In a study by Small et al., investigators evaluated the safety, efficacy, and patient acceptance of triamcinolone acetonide aerosol vs. fluticasone propionate aqueous nasal sprays. Patients aged 12 to 70 were screened for comorbid conditions and recent use of steroids or other treatments such as oral decongestants and antihistamines. The trial included patients with a Rhinitis Index Score (RIS = nasal

congestion + rhinorrhea + sneezing + itching) of at least 24 of 48 in 4 of the last 5 days at the time of screening.

Two hundred and thirty-three otherwise healthy individuals with spring (pollen) seasonal allergic rhinitis were randomly assigned to receive either 220 micrograms of triamcinolone or 200 micrograms of fluticasone once daily in the morning. Patients returned for follow-up visits at 1 and 3 weeks to analyze any change in symptoms, which were assessed on a scale of 0 to 3 (0 = no effect on symptoms, 3 = greatly reduced symptoms). A mean of RIS and individual symptoms was calculated from the baseline-reported values and compared to RIS and individual symptoms at each follow-up visit. Both groups experienced a statistically significant improvement in overall symptom scores (-4.20 ± 0.21 for triamcinolone; -4.60 ±0.21 for fluticasone), but there were no significant differences between the groups for change in RIS or individual values. Safety outcomes were similar across both groups; the most common adverse effects were headache at 5% and 9% and epistaxis at 3% and 4% in the triamcinolone and fluticasone groups, respectively.

One patient in the triamcinolone group withdrew due to severe headache. Patient acceptance of medication was the only statistically significant difference between the groups; more medication causing dry nostrils or stuffy nose was reported with triamcinolone and more medication running out of the nose or down the throat was reported with fluticasone. These differences were attributed to the aerosol and aqueous formulations. The authors concluded that triamcinolone and fluticasone are equally effective, safe, and well-tolerated for the treatment of seasonal allergic rhinitis.4 A randomized, blinded, parallel-group trial by Gross et al. similarly investigated the safety, efficacy, and quality of life of triamcinolone and fluticasone. Patients aged 12 to 70 were screened at baseline for other significant conditions or drug use including steroids and antihistamines. There was a 5-day baseline period before randomization when all rhinitis medications were discontinued. Patients were included if they tested positive for fall (ragweed) seasonal allergic rhinitis and had a Total Nasal Symptom Score (TNSS = discharge, stuffiness, itching, sneezing) of at least 42 of 84 on 4 of the 5 baseline days. Three hundred and fifty-two patients were randomly assigned to receive either 220 Fall 2014 • Arizona Journal of Pharmacy • 27

DIQ micrograms of triamcinolone or 200 micrograms of fluticasone daily each morning. Patients recorded reflective symptom assessments every morning and evening on a scale of 0 to 3 (0 = no symptom, 3 = severe symptoms that interfere with daily living) and had a follow-up visit at 3 weeks. Patients also completed a Rhinitis Quality of Life Questionnaire (RQLQ) at enrollment and follow-up. The RQLQ included 7 dimensions (activities, emotions, eye symptoms, nasal symptoms, non-hay fever problems, practical problems, and sleep), which were scored individually and overall on a 7-point scale. There was a statistically significant improvement in TNSS within each group compared to baseline (-49.4% for triamcinolone; -52.7% for fluticasone), but no statistically significant differences between the groups were found at any time point for both overall and individual symptoms. Adverse effects were similar in both groups. RQLQ results indicated similar quality of life at baseline and similar improvements at follow-up in both groups. The authors also investigated patient acceptance, as done by Small et al., and found that those in the triamcinolone group were significantly more likely to report medication running out of the nose or causing sneezing, while those in the fluticasone group were significantly more likely to report that the medication smelled bad. The authors concluded that triamcinolone and fluticasone have comparable efficacy in the treatment of seasonal allergic rhinitis with similar side effects and improvements in quality of life.5 A third study, performed by Berger et al., used similar methods to evaluate the safety, efficacy, and quality of life of triamcinolone and fluticasone nasal sprays. Patients aged 12 to 70 were screened for unstable conditions and medication use such as steroids or antihistamines. The methods were the same as those used by Gross et al., including baseline assessments, TNSS and RQLQ measures, and follow-up assessments. Exceptions included assessment of the effects in spring seasonal allergic rhinitis and a use of a 100-point questionnaire to measure patient acceptance. Two hundred and ninety-five patients were randomly assigned to receive 220 micrograms of triamcinolone or 200 micrograms of fluticasone daily each morning. Both agents were effective at reducing TNSS (-3.15 ± 0.19 for triamcinolone; -3.17 ± 0.18 for fluticasone), with no statistical differences between the groups at any time point. A similar rate of adverse events occurred in both groups. RQLQ results improved in both groups, but were not statistically different between the groups. Finally, the only significant difference in patient acceptance was lower reports of unpleasant odor with triamcinolone. The authors concluded that triamcinolone and fluticasone were equally efficacious in relieving symptoms and improving quality of life.6 An article from Kaiser et al. utilized the same data from the trial by Berger et al., but reanalyzed it using more specific comparisons. Based on the TNSS endpoint, the

authors further categorized patients from each group as having moderate (mean TNSS <8.14) or severe (mean TNSS ≥8.14) allergic rhinitis symptoms at baseline. The classifications were based on the median TNSS to produce groups of equal size. The results showed an improvement from baseline in all groups, but no statistical difference between triamcinolone and fluticasone, which was consistent with the previous analysis. In patients with moderate symptoms, the mean change in TNSS was -2.40 for triamcinolone and -2.22 for fluticasone (36 to 39% improvement). In patients with severe symptoms, the mean change in TNSS was -3.85 for triamcinolone and -3.84 for fluticasone (38 to 41% improvement). Side effect profiles and RQLQ endpoints similarly showed no statistical difference between the agents in either categorization.

The authors concluded that once-daily triamcinolone and fluticasone nasal sprays provided significant and comparable relief of symptoms and improvements in quality of life in patients with seasonal allergic rhinitis.7 Discussion All of the articles found similar efficacy results for triamcinolone and fluticasone, with a reduction in nasal symptoms of 30 to 50% from baseline over a period of 3 weeks and no significant differences between the groups. These findings are reflected in the 2008 AAAAI/ACAAI guidelines, which state that all intransasal steroids are considered to be similar in terms of clinical response.1 Additionally, the data from the studies seem to support the theory that topical potency of intranasal steroids is unrelated to clinical efficacy.

The most common side effects of intranasal steroids are headache and pharyngitis, which are consistent with the safety results in the studies. More serious but rare side effects include anaphylaxis, nasal septum perforation, and increased intraocular pressure.

Intranasal steroids are not associated with any significant drug interactions when used appropriately because of their local effects. If used excessively, systemic absorption may lead to side effects that occur with oral steroids, such as adrenal suppression or immunosuppression.12 Nasacort® has become an OTC product and is no longer available by prescription.13 It should not be used in children under the age of 2 years and should be used with caution in pregnant women.12 As a result of the transition in status of Nasacort®, pharmacists can consider intranasal steroids as an option when making an OTC product recommendation for allergic rhinitis.

References 1. Wallace DV, Dykewicz MS, Bernstein DI et al. The diagnosis and management of rhinitis: an updated practice parameter.

J Allergy Clin Immunol. 2008 Aug;122(2 Suppl):S1-84.

DIQ 2. Bousquet J, Khaltaev N, Cruz AA et al. Allergic Rhinitis and its Impact on Asthma (ARIA) 2008 update. Allergy. 2008 Apr;63(86 Suppl):8-160.

3. deShazo RD, Kemp SF. Pharmacotherapy of allergic rhinitis. In: Corren J, Feldweg AM, eds. UpToDate.

2014 Feb 14. (accessed 2014 March 6).

4. Small P, Houle PA, Day JH et al. A comparison of triamcinolone acetonide nasal aerosol spray and fluticasone propionate aqueous solution spray in the treatment of spring allergic rhinitis. J Allergy Clin Immunol. 1997 Nov;100(5):592-5.

5. Gross G, Jacobs RL, Woodworth TH et al. Comparative efficacy, safety, and effect on quality of life of triamcinolone acetonide and fluticasone propionate aqueous nasal sprays in patients with fall seasonal allergic rhinitis. Ann Allergy Asthma Immunol. 2002 Jul;89(1):56-62.

6. Berger WE, Kaiser H, Gawchik SM et al. Triamcinolone acetonide aqueous nasal spray and fluticasone propionate are equally effective for relief of nasal symptoms in patients with seasonal allergic rhinitis. Otolaryngol Head Neck Surg. 2003 Jul;129(1):16-23.

7. Kaiser HB, Liao Y, Diener P et al. Triamcinolone acetonide and fluticasone propionate nasal sprays provide comparable relief of seasonal allergic rhinitis symptoms regardless of disease severity. Allergy Asthma Proc. 2004 NovDec;25(6):423-8.

8. Bartholow M. Top 200 drugs of 2012. http://www.pharmacytimes.com/publications/issue/2013/July2013/Top-200Drugs-of-2012 (accessed 2014 March 20).

9. Food and Drug Administration. Summary minutes of the nonprescription drugs advisory committee meeting. http://www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials/drugs/nonprescriptiondrugsadvisorycommittee/ucm371010.pdf (accessed 2014 March 10).

10. Food and Drug Administration. FDA approves over-the-counter Nasacort Allergy 24HR to treat hay fever and nasal allergies. http://www.fda.gov/Drugs/NewsEvents/ ucm370973.htm (accessed 2014 March 10).

11. Sanofi. Sanofi’s consumer healthcare division Chattem announces Nasacort® Allergy 24HR nasal spray now available without a prescription in the U.S. http://www.multivu.com/ mnr/7098701-nasacort-allergy-24hr-nasal-spray-now-available-without-a-prescription (accessed 2014 March 10).

12. Lexi-Comp, Inc. (Lexi-Drugs™). Lexi-Comp, Inc; March 24, 2014.

13. Chattem, Inc. Frequently asked questions: Nasacort®. http://www.nasacort.com/faq.aspx (accessed April 1, 2014).

Arizona Pharmacy Association Mentor Connection Program

ment got 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), and technician (mentor or mentee) members.

The Arizona Pharmacy Association presents PTCB EXAM REVIEW COURSE COMPLETELY REVISED CONDUCTED IN 7 ONLINE PRE-RECORDED WEBINARS*.

Only $395 Go to www.azpharmacy.org to register. *Class requirements: Internet connectivity, Windows Media Player and Adobe Acrobat Reader are required for participation in this class.

System Requirements PC-based attendees • Required: Windows® 7, Vista, XP or 2003 Server Macintosh®-based attendees • Required: Mac OS® X 10.6 or newer Mobile attendees • Required: iPhone®, iPad®, Android™ phone or Android tablet

Arizona Pharmacy Association presents Arizona Pharmacy Law and Public Policy Course COMPLETELY REVISED! The ideal preparation for the MPJE! Available on-demand at the Arizona Center for Professional Education website. Registration is available online only at: www.azpharmacy.org/ Pharmacy_Law Full Course - 9.0 hours continuing pharmacy education (0.90 CEUs) AzPA Member: $200 Non-Member: $300 Student*:

$100 *Not eligible for continuing pharmacy education credit.

Companion textbook available for purchase at www.azpharmacy.org/Law_Textbook

For more information about how to be a part of the AzPA MCP, contact Kelly Ridgway, AzPA CEO at kelly@azpharmacy.org Fall 2014 • Arizona Journal of Pharmacy • 29

Academy News

Community Pharmacy Academy News It is a great honor to serve as chair of the Community Pharmacy Academy this year, and an opportunity to represent all the pharmacists in the practice. My ultimate goal is to unite all pharmacists, starting with community practice pharmacists; to encourage support and communication within our profession. I would like to thank the out-going chair, Betty Louton, for her devotion to the CPA’s causes; her direction and invaluable leadership.

During the June 2014 AzPA Convention, the Community Pharmacy Academy held a meeting to discuss ways to promote greater participation and involvement in the academy by fellow pharmacist. The idea was proposed to publish articles highlighting a day in the life of community practice pharmacists working in various settings.

To show support for independent pharmacy enterprise within the Academy, Valerie Bostel and I attended and listened to issues at the Independent Pharmacy Owner meeting, alongside other CPA members and supporters.

CPA held a booth for the first time at an AzPA convention to reach out to potential members. A tri-fold poster, designed by an AzPA volunteer, provided the Academy with an eye-catching presentation. In addition to this, fifty flyers were designed, printed, and distributed with additional information about the Community Pharmacy Academy. I am very pleased to announce that the CPA’s executive board has already been filled with promising officials: Virginia Boomershine, Community Chair; Lori Drea, Continuing Education Chair; Sophia Galloway, Legislature Chair.

We thank them for their volunteerism; their devotion, and the great effort we know they will contribute in the future. Also, we are always looking for more people with fresh ideas and energy needed to help unite the academy. The CPA holds monthly conferences at 7 AM on the third Thursday of each month, during which time we encourage members to dial in, join our discussions, and voice their ideas.

We are excited to invite all pharmacists to participate in our Fall conference on Sat., November 15th 2014. The day’s events will provide a good source of CEs, in addition to the well sought-after law CEs. Looking forward to seeing you all again soon!

Grace Akoh-Arrey, Pharm.D., CDE, BCACP Community Pharmacy Academy Chair cpa@azpharmacy.org

Geriatric Care Academy News I am looking forward to serving as the chair of the Geriatric Care Academy (GCA). I would like to thank Dr. Elizabeth Pogge, the immediate past chair of the GCA, for her leadership and mentorship over the past year.

I would also like to take this opportunity to welcome Dr. Jessica DiLeo to the Board of Directors as the GCA Chair-Elect.

The 2014-2015 goals for the GCA include increasing AzPA member involvement within the academy, providing education about geriatric pharmacy to other health care professionals and patients, and serving the geriatric population. The GCA is planning a variety of events over the course of the next year. I encourage all members to attend our monthly conference calls on the second Wednesday of the month at 12:30pm for additional information and to get involved within the academy.

The AzPA Fall Conference will be held the weekend of November 15th at the Kroc Corps Community Center in Phoenix, Arizona. Be on the lookout for additional details as they are released in the coming weeks regarding this excellent opportunity for educational CEs and networking. Finally, I would like to invite all members of the GCA to attend the 2014 American Society of Consultant Pharmacists (ASCP) Annual Meeting and Exhibition that is scheduled for November 5-7th in Orlando, Florida.

I am looking forward to an exciting year for the GCA. If you have any Nicole K. Kitts, PharmD, BCPS, CGP questions or are interested in getting more involved within the academy, Geriatric Care Academy Chair gca@azpharmacy.org please contact me at any time.

Health-System Academy News

Hopefully everyone is enjoying their summer and staying cool in this Arizona heat. For those of you unable to attend the 2014 AzPA Annual Convention, there was a great turnout overall and good representation of HSA members! We were honored to have Dr. Paul Abramowitz, ASHP Chief Executive Officer, attend our HSA business meeting.

Other highlights from the meeting include the House of Delegates report. The HOD approved 25 policy items and provided updates to the ASHP bylaws at the ASHP Summer meeting in June. Read more about these items in this Journal. We were also excited to discuss the continued success of our mentor-mentee program.

HSA currently has 48 mentors and 68 mentees. Our goal is to continue to grow this upcoming year.

This past spring, we held our first conference call about Pharmacy Practice Model Initiative. We discussed strategies to increase awareness and improve Arizona’s PPMI Hospital Self-Assessment completion rate. We will be developing those strategies in the coming months.

HSA continues to strive for new goals. During the last business meeting we developed a new goal to submit at least 1-2 CE articles annually to the AzPA Journal. Feel free to contact the HSA leadership hsa@azpharmacy.org if you have any questions, comments, or suggestions.

Mitchell Buckley, FASHP, FCCM, BCPS Health-System Academy Chair hsa@azpharmacy.org The Health-System Academy of the Arizona Pharmacy Association is the Arizona affiliate of the American Society of Health-System Pharmacists (ASHP).

Managed Care Academy News I am privileged to represent the Managed Care Academy of AzPA as its Chair. We had a wonderful kickoff at the annual AzPA convention; including, a good discussion on where to take the Academy in 2014-2015. Past and future leaders of the Academy gathered at AzPA to discuss current trends in the profession and methods to reach others within the organization to get involved. We discussed possible topics to bring to the Academy during conventions and gatherings, such as Medicare Star ratings. We also discussed possible outreach events to get others involved in what is becoming a growing aspect of pharmacy practice.

I urge all pharmacists involved in managed care to get involved with our Academy and promote our profession. It will be a great opportunity for all of us to discuss, share and highlight up and coming trends in the field as well as share best practices in how to serve our patients. I look forward to this upcoming year and I am excited for the opportunity to lead this Academy. I urge members of AzPA involved in managed care to reach to me, or AzPA, to find ways to get involved.

For those attending AMCP’s Nexus Conference in Boston this October, AzPA has reserved a conference room to host a gathering for Arizona pharmacist representatives during the conference. Please join Ann Sears and I on Oct 9, 2014 at 7am.

Paul Lynne, Pharm.D., Managed Care Academy Chair mca@azpharmacy.org

ACADEMY NEWS

Fall 2014 • Arizona Journal of Pharmacy • 31

Student Pharmacist Academy News This past semester, the Student Pharmacist Academy at the University of Arizona did several screenings at health fairs with our new osteoporosis service. Katy’s Kids events were held at a local elementary school to help teach children about proper medication use and the dangers of abuse. During a lunch meeting, the CEO of Canyon Ranch Institute, Jennifer Cabe, discussed the importance of health literacy and health prevention.

The student members elected our new executive board, including our new Chair-elect, Mika Jankowski. We are excited for the incoming class this August and are planning events that we hope will engage students.

Midwestern students have been busy. A new class of students began their classes in June and, along with other organizations, we participated in a Membership Drive to boost student participation for the new and existing classes. On that same note, the new class of students were introduced to AzPA-SPA through a presentation given just before the Annual Convention in hopes of encouraging these new students to attend.

Students from both Midwestern University and the University of Arizona worked hard in concert to set up the student track for this year’s annual conference. Held at the Wigwam Resort in Litchfield Park, this year’s student track encouraged students to get involved. A Pharmacy Practice Model Initiative workshop was held allowing students to discuss the future of pharmacy and ways to achieve change in future work environments.

Other students put together short presentations on topics of interest and did whirlwind rundowns for their peers. Students were also given the opportunity to participate in mock interviews and poster presentation sessions. They then helped put together a casino night social, enjoyed by students and pharmacists. The last student session allowed for free discourse with different leaders in the field of pharmacy, allowing students to glean specific information about different areas of practice.

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 It was great to see you all at the Annual Convention! A special thanks to those who were able to attend the Technician Academy Town Hall. You shared great ideas that we hope to implement in the coming year.

In the past quarter, we have been brainstorming ideas for potential certificate programs aimed at technicians. “Diabetes Meter Training” will be the first; and we hope to offer it at the fall conference. We have also been working with the Mentoring committee to encourage technician participation as both mentors and mentees.

Over the next few months we will develop the CE ideas shared at the town hall. We also hope to increase participation in the academy using social media opportunities. Our next Technician Academy meeting will be August 13th at 7PM. This meeting will be open to everyone, so be sure to update your email on your AZPA website so you can receive the agenda details.

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

ACADEMY NEWS

CONTINUING EDUCATION Pharmacotherapy for Weight Loss: Magic Bullets or Inevitable Failures?

By: Elizabeth Pogge, PharmD, MPH, BCPS, FASCP Jiten Sidhu, MWU PharmD Candidate Class of 2014 Goal This home-study CPE activity has been developed to educate pharmacists and pharmacy technicians on the pharmacotherapy available for the treatment of obesity.

Objectives 1. Describe the current obesity epidemic and how it impacts healthcare.

2. Describe the appropriate patient in which to recommend pharmacotherapy for the treatment of obesity.

3. Compare and contrast the different pharmacotherapy available to treatment obesity, including efficacy, common adverse events, contraindications, interactions, and counseling points.

Introduction Obesity in the United States (US) is reaching epidemic proportions. The 2009-2010 National Health and Nutrition Examination Survey indicated that 33.1% of US adults over the age of 20 are overweight (body mass index (BMI) 25-29.9 kg/m2), 35.7% are obese (BMI 30-39.9 kg/m2), and 6.3% are extremely obese (BMI > 40 kg/m2).1 Obesity has been associated with several chronic disease states, including hypertension, dyslipidemia, Type 2 diabetes, coronary heart disease, stroke, gallbladder disease, osteoarthritis, sleep apnea, respiratory problems, and some cancers.2 As is not surprising, obesity costs in the US are increasing. In 2008 dollars, obesity costs totaled about $147 billion.3 The causes of obesity in the US are a complex mix of social and cultural attributes, from sedentary lifestyles to unhealthy choices in regards to diet.

Complex causes need complex solutions, including dietary changes, physical activity, and changes in behavior.2 Pharmacotherapy may also play a role in the treatment of obesity, with more options becoming available in recent years.

In 2013, the obesity guidelines were updated by the American Heart Association, American College of Cardiology, and the Obesity Society. These guidelines use a critical question approach in which they address the expected health benefits of weight loss, discuss the health risks of being overweight or obese, analyze dietary interventions, evaluate comprehensive lifestyle approaches, and analyze bariatric surgical procedures.2 A complete review of the guidelines is beyond the scope of this article, but several key principals are important when considering pharmacotherapy. One principal, matching treatment benefit with risk profiles, is of utmost importance when considering pharmacotherapy. The

guidelines state that a 3-5% sustained weight loss is likely to results in clinically meaningful reductions in triglycerides, blood glucose, and the risk of developing type 2 diabetes; while greater amounts will reduce blood pressure, low-density lipoprotein cholesterol (LDL-C) and high-density lipoprotein cholesterol (HDL-C), as well as medications to control blood pressure, blood glucose, and lipids.2 The guidelines also recommend that individuals wanting to lose weight participate in a > 6 month high-intensity lifestyle intervention that includes a reduced窶田alorie diet, increased physical activity, and behavioral therapy (Figure 1).

Pharmacotherapy If a high-intensity lifestyle intervention alone is not successful or has failed in the past, pharmacologic agents may be indicated as adjunctive treatment. The current indication for pharmacotherapy includes have a BMI > 30 kg/m2 or having a BMI > 27 kg/m2 with an additional comorbid disease state, such as type 2 diabetes, hypertension, or dyslipidemia.2 The guidelines do not fully address the efficacy of pharmacotherapy as only one medication was approved for long-term treatment of weight loss during the development of the guidelines. Since their development, 2 additional medications have been approved for long-term treatment of weight loss, making pharmacotherapy an option for more patients (Table 1).

Agents approved for short-term treatment of obesity There are 4 agents approved for the short-term treatment of obesity. They are all sympathomimetic amines and stimulate the sympathetic nervous system by several mechanisms, including the blockage of norepinephrine reuptake.4 They are currently food and drug administration (FDA) approved for treatment of obesity as an adjunctive agent to lifestyle modification and should only be used in the shortterm (<12 weeks).5-8 Dosing for each agent is variable and depends on the formulation, with several extended release formulations available. All agents are dosed in the morning as insomnia is a common side effect. Due to the potential for abuse, all agents are FDA scheduled III or IV controlled substances. The lowest effective dose should be used to avoid or delay the tolerant effects that can occur with higher doses.

Fall 2014 窶｢ Arizona Journal of Pharmacy 窶｢ 33

Pharmacotherapy Figure 1: Components of a high-intensity lifestyle intervention

Figure adapted from reference 2 Table 1. Mechanism of action and dosing of agents FDA approved for treatment of obesity Medication Phentermine (Adipex-P®) Benzphetamine (Didrex®) Diethylpropion

Mechanism Sympathomimetic amines

Phendimetrazine (Bontril®) Orlistat (Alli® OTC) (Xenical®)

Lipase inhibitor

Phentermine/topiramate CR (Qsymia®)

Sympathomimetic amines/ anticonvulsant

Lorcaserin (Belviq®)

5-HT2C receptor agonist

Table adapted from references 5-8,11,13,18

Dosing 18.75-37.5 mg up to three times a day or 15-30 mg daily 25-50 mg up to three times a day

25 mg three times a day or 75 mg daily 17.5-35 mg up to three times a day or 105 mg daily 60 mg up to three times a day 120 mg up to three times a day

3.75 mg/23 mg - 15 mg/ 92 mg once a day 10 mg twice a day

Table 2. Characteristics of agents approved for long-term treatment of obesity Agent

Orlistat

Renal dosing

None

FDA schedule

None

Protein binding Elimination

Minimal

Half-life

97% fecal 1-2 hours

Common Gastrointestinal adverse effects Rare adverse effects

Liver failure

Table adapted from references 11,13,18

CONTINUING EDUCATION

Phentermine/ topiramate CR Schedule IV

CrCl < 50 mL/min: do not exceed 7.5 mg/ 46mg once a day 15-41%

CYP3A4 substrate and inducer; inhibits CYP2C19 Phentermine: 20 hours Topiramate: 65 hours Paraesthesia, dizziness, insomnia, dry mouth, anxiety, constipation, infection, increased heart rate Mood changes, birth defects with first trimester exposure, metabolic acidosis

Lorcaserin Schedule IV

CrCl < 50 mL/min: use with caution 70%

CYP2D6 inhibitor 11 hours

Headache, nausea, dizziness, fatigue, infection, constipation, dry mouth Valvular heart disease

Once these effects occur it is recommended to discontinue the medication. Other adverse effects that may occur when using sympathomimetic amines include increased heart rate, increased blood pressure, constipation, sweating, dry mouth, insomnia and various other stimulant effects.5-8 It is important to note that sympathomimetic amines should not be given with antidepressants because this puts the patient at risk for developing serotonin syndrome.

The efficacy of sympathomimetic agents are similar; with a mean weight loss of approximately 3 kg when compared to placebo.9 A meta-analysis looking at the sympathomimetic amines included 18 trials ranging from 2-52 weeks, average 13.2 weeks, resulted in a mean weight loss of 3 to 3.6 kg compared to placebo.9 One of the longest clinical trials with phentermine included 64 women and showed superior results with a mean weight loss of 7.8 kg compared to placebo over 36 weeks.10 Clinical trials including sympathomimetic agents are generally older studies, of poor design as they include a small number of patients and are of short duration.

Agents approved for long-term treatment of obesity There are currently 3 agents approved for the long-term treatment of obesity. The oldest agent, orlistat, has been around since 1999.11 It is available via prescription as well as over-thecounter. In 2012, 2 new agents were FDA approved for the long-term treatment of obesity, phentermine/topiramate CR and lorcaserin. These agents became the first new agents in over a decade to be approved for the treatment of obesity. All agents are pregnancy category X, should be given in additional to lifestyle modification, and should include intensive follow up and monitoring.11,13,18 The characteristics of these agents are listed in Table 2.

Orlistat is a gastric and pancreatic lipase inhibitor that prevents hydrolysis and absorption of approximately 30% of fat contained in a meal.4 It comes in two forms, the over-the-counter strength Alli®

Pharmacotherapy or the prescription strength Xenical®. Both are taken orally 3 times daily during or within one hour of each meal containing fat, with the only difference being dosing (Alli® is 60 mg and Xenical® is 120 mg).11 Patients should not take a dose if the meal they are consuming does not contain any fat, as the agent will have little effect. It is important to note that orlistat can decrease the absorption of fat soluble vitamins so patients should be counseled to take a multiple vitamin separated from their orlistat dose by at least 2 hours.

Studies have shown that orlistat is effective for weight loss and can be used for long-term therapy; up to 2 years. A meta-analysis that included 16 trials with 10,631 patients on orlistat therapy for at least 1 year showed a mean weight loss of 2.9 kg compared to placebo.12 Furthermore, orlistat reduced the incidence of diabetes, reduced cholesterol levels and blood pressure, and improved glycemic control in those with diabetes. Orlistat is relatively safe compared to other anti-obesity agents, but it still has some adverse effects.

Main side effects of note are oily spotting, oily stools, abdominal pain, flatulence, and diarrhea.11 There have also been cases of hepatic related adverse effects, including severe liver injury. Patients should be instructed to report any symptoms of liver dysfunction while taking orlistat to their provider.

Qsymia® is a new combination drug consisting of phentermine and controlled release topiramate.

Phentermine alone is FDA approved for the treatment of obesity while topiramate is an antiepileptic with an unknown mechanism of action in treating obesity. The combination comes in different strengths, all taken once daily in the morning.13 The starting dose is phentermine 3.75 mg/topiramate CR 23 mg for 14 days, then the dose should be increased to phentermine 7.5 mg/topiramate CR 46 mg. After 12 weeks at this dose, if weight loss is not at least 3% of baseline, then the dose can be titrated up to phentermine 11.25 mg/ topiramate CR 69 mg or discontinued. This dose should be continued for 14 days then the agent should be titrated up to the maximum dose of phentermine 15 mg/topiramate CR 92 mg. Weight loss should be evaluated after 12 weeks at this dose and if weight loss is not at least 5% of baseline, then the agent should be discontinued. To reduce the possibility of precipitating a seizure, discontinue the use of phentermine/topiramate CR gradually by taking a dose every other day for at least 1 week.

Phentermine/topiramate CR is on a Risk Evaluation and Mitigation Strategy (REMS) in which it is only available via certified pharmacies and by certified healthcare providers.13 This is due to the potential risk of developing oral clefts in fetuses of pregnant women who are exposed to the medication during the first trimester.

Women of child bearing age should be aware of this CONTINUING EDUCATION

potential problem, be instructed to use adequate birth control, and be counseled to discontinue the medication immediately if they become pregnant. It has been noted that topiramate can decrease the efficacy of oral contraceptives resulting in irregular bleeding, although the package insert of phentermine/topiramate CR state that an increased risk of pregnancy is not anticipated. To be safe, some professionals recommend multiple contraceptive methods in women of childbearing age. Phentermine/topiramate CR has several drug interactions, mostly due to the topiramate component.

Some common drug interactions include metformin, hydrochlorothiazide, and anticonvulsants.

The controlled-release phentermine/topiramate in severely obese adults: a randomized controlled trial (EQUIP) was designed to evaluate the efficacy of phentermine 3.75 mg/topiramate CR 23 mg or phentermine 15 mg/topiramate CR 92 mg compared to placebo in 1,267 patients.14 All patients were given intensive lifestyle counseling and followed for 56 weeks. The study only included severely obese patients with a BMI > 35 kg/m2. Mean weight losses were 1.8 kg (placebo), 6 kg (3.75 mg/23 mg), and 12.6 kg (15 mg/92 mg) at 56 weeks. The effects of low-dose, controlled release, phentermine plus topiramate combination on weight and associated comorbidities in overweight and obese adults (CONQUER) trial was a similar study in which 2,487 patients were randomized to phentermine 7.5 mg/ topiramate CR 46 mg, phentermine 15 mg/topiramate 92 CR mg, or placebo.15 Patients were included if they had a BMI of 27-45 kg/m2 and at least 2 comorbidities (hypertension, dyslipidemia, diabetes/prediabetes, or abdominal obesity). The same intensive lifestyle counseling was given to all patients and they were followed for 56 weeks. Mean weight losses were 1.2 kg (placebo), 8 kg (7.5 mg/46 mg), and 10.1 kg (15 mg/92 mg). The two-year sustained weight loss and metabolic benefits with controlled-release phentermine/topiramate in obese and overweight adults (SEQUEL) trial was a 52 week extension study of the CONQUER trial in which select sites were asked to continue their originally assigned treatment. This trial included 676 patients that continued their assigned medication or placebo for up to 2 years.16 At the end of the study, mean weight losses were 1.8 kg (placebo), 9.5 kg (7.5 mg/46 mg), and 10.7 kg (15 mg/92 mg). In all studies, the medication was well tolerated with adverse effects that had a greater than 5% incidence being paraesthesia, dizziness, insomnia, constipation, and dry mouth.14-16 Each of these studies had a dose dependent decrease in comorbidities including waist circumference, systolic and diastolic blood pressure, fasting glucose, and lipid levels, although all reduction were not statistically significant.14-16 The last of the anti-obesity agents is lorcaserin (Belviq®). Lorcaserin selectively targets the 5-hydroxytryptamine receptor 2C.17 It is dosed at 10 mg twice daily. If there is not a greater than 5% weight Fall 2014 • Arizona Journal of Pharmacy • 35

Pharmacotherapy reduction in 12 weeks then the agent should be discontinued.18 Since lorcaserin works on serotonin receptors, there is a potential for serotonin syndrome if it is used concomitantly with other serotonergic agents.

A meta-analysis by Chan et al. consisted of 3 randomized controlled trials that studied lorcaserin for weight loss. These studies included 7,789 patients and found that lorcaserin resulted in an average weight loss of 5.4 kg compared to a 2.2 kg weight loss in the placebo group.19 Also, there were statistically significant reductions in waist circumference, blood pressure, total cholesterol, LDL-C and triglyceride levels, but no effect on HDL-C or heart rate. Headache, diarrhea, nausea, infection, and dizziness are the more common adverse effects.18 Rare side effects include valvular heart disease, cognitive impairment, psychiatric disorders, decrease in heart rate, hypoglycemia, priapism, decreased white blood cell count, prolactin elevation, and pulmonary hypertension.

When matching treatment benefit with risk profile, the obesity guidelines state that a 3-5% sustained weight loss can affect comorbid conditions. When looking at the current agents for treatment of obesity, clinical trials show that each agent has the potential to achieve this percentage weight loss (Table 3).

Table 3: Summary of select clinical trials of agents approved for treatment of obesity Trial

Meta-analysis of 16 trials (n = 10,631)

SEQUEL (n = 676)

Meta-analysis of 3 trials (n=7,789)

Drug Dose

orlistat 120 mg three times a day

phentermine/topiramate 7.5/46 mg or 15/92 mg daily Placebo ~53 2 years

lorcaserin 10 mg once or twice a day

~101.7 kg Randomized-controlled trials 500 calorie per day deficit diet along with nutritional and exercise counseling

~101.6 kg Randomized-controlled trials 600 calorie per day deficit diet along with nutritional and exercise counseling

Compared to Average age Median duration of follow up Baseline BMI Baseline weight Trial design

Co-intervention Results

Co-morbidities affected

Placebo 41-59 1-4 years

32-37 kg/m2

95-111 kg Randomized-controlled trials 500-900 calorie per day deficit diet along with nutritional and exercise counseling 3.6% vs.

6.6% Net weight loss: 2.9%

Diabetes, LDL-C, blood pressure, glycemic control in patients with diabetes Table adapted from references 12,16,19

~ 36 kg/m2

1.8% vs.

7.5/46 mg: 9.3% vs.

15/92 mg: 10.5% Waist circumference, LDLC, triglycerides, fasting glucose

Placebo 45-55 1-2 years

~35 kg/m2

2.2% vs.

5.3% Net weight loss: 3.2%

Waist circumference, blood pressure, LDL-C, triglycerides

Conclusion Based on clinical trial data, it appears as if pharmacotherapy should be considered in patients who have failed 6 months of intensive lifestyle modification. Overall, these agents all decrease weight by at least 3-5%, with the potential to reduce comorbidities. When dispensing these medications, it is important to counsel on lifestyle modification including diet, exercise, and behavioral therapy as these agents should all be given with intensive lifestyle modification. As is noted in the adverse effects of these agents, each agent carries some risk.

With the history of anti-obesity agents being removed from the market due to serious adverse effects, it is important that pharmacists help monitor patients for serious adverse effects and report any adverse effects to the FDA. Until these agents CONTINUING EDUCATION

get more clinical experience, the question remains if the benefit of these agents outweighs the risks associated with them.

With the additional of 2 new agents in the past several years, it is likely that more new anti-obesity agents will hit the market in the near future. Current agents that are FDA approved for the treatment of other diseases states but have been studied for obesity include fluoxetine, sertraline, bupropion, topiramate, zonisamide, lamotrigine, metformin, pramlintide and exenatide4. Also, pharmaceutical companies continue to look for new areas to target, with medications that increase energy expenditure and medications that affect genetic factors being potentially useful in the treatment of obesity. With the rising incidence as well as the high cost associated with obesity, medications that are safe and effective could help combat this epidemic.

References 1. Flegal KM, Carroll MD, Kit BK, Ogden CL. Prevalence of obesity and trends in the distribution of body mass index among US adults, 1999-2010. JAMA. 2012;307(5):491-7.

2. Jensen MD, Ryan DH, Apovian CM, et al. 2013 AHA/ACC/ TOS guidelines for the management of overweight and obesity in adults: A report of the American College of Cardiology/American Heart Association task force on practice guidelines and the Obesity Society. Circulation. 2013; published online November 12, 2013.

3. Finkelstein EA, Trogdon JG, Cohen JW, Dietz W. Annual medical spending attributable to obesity: payer-and service-specific estimates. Health Aff. 2009;28:w822–31.

4. Bray GA. Medications for weight reduction. Med Clin N Am. 2011; 95:989-1008.

5. Benzphetamine. In: DRUGDEX [Internet Database].

Greenwood Village, CO. Truven Health Analytics Inc. Updated 2013 Oct. 6. Diethylpropion. In: DRUGDEX [Internet Database]. Greenwood Village, CO. Truven Health Analytics Inc. Updated 2013 Nov. 7. Phendimetrazine. In: DRUGDEX [Internet Database].

Greenwood Village, CO. Truven Health Analytics Inc. Updated 2013 Nov. 8. Phentermine. In: DRUGDEX [Internet Database]. Greenwood Village, CO. Truven Health Analytics Inc. Updated 2013 Oct. 9. Haddock CK, Poston WS, Dill PL, Foreyt JP, Ericsson M. Pharmacotherapy for obesity: a quantitative analysis of four decades of published randomized clinical trials. Int J Obes Relat Metab Disord. 2002; 26(2):262–273.

10. Munro JF, MacCuish AC, Wilson EM, Duncan LJ. Comparison of continuous and intermittent anorectic therapy in obesity. Br Med J. 1968;1(5588):352–54.

11. Orlistat. In: DRUGDEX [Internet Database]. Greenwood Village, CO. Truven Health Analytics Inc. Updated 2013 Nov. 12. Rucker D, Padwal R, Li SK, Curioni C, Lau DC. Long term pharmacotherapy for obesity and overweight: updated meta-analysis. BMJ. 2007;335(7631):1194–9.

13. Phentermine/topiramate. In: DRUGDEX [Internet Database]. Greenwood Village, CO. Truven Health Analytics Inc. Updated 2013 Nov. 14. Allison DB, Gadde KM, Garvey WT, et al. Controlled-release phentermine/topiramate in severely

Pharmacotherapy obese adults: a randomized controlled trial (EQUIP).

Obesity. 2012; 20(2):330-42.

15. Gadde KM, Allison DB, Ryan DH, et al. Effects of lowdose, controlled-release, phentermine plus topiramate combination on weight and associated comorbidities in overweight and obese adults (CONQUER): a randomised, placebo-controlled, phase 3 trial. Lancet.

2011; 377(9774):1341-52.

16. Garvey WT, Ryan DH, Look M, et al. Two-year sustained weight loss and metabolic benefits with controlled-release phentermine/topiramate in obese and overweight adults (SEQUEL): a randomized, placebo-controlled, phase 3 extension study. Am J Clin Nutr. 2012; 95(2):297-08.

17. Gustafson A, King C, Rey JA. Lorcaserin (Belviq): A selective serotonin 5-HT2C agonist in the treatment of obesity. P T. 2013; 38(9):525-34.

18. Lorcaserin. In: DRUGDEX [Internet Database]. Greenwood Village, CO. Truven Health Analytics Inc. Updated 2013 Oct. 19. Chan EW, He Y, Chui CS, et al. Efficacy and safety of lorcaserin in obese adults: a meta-analysis of 1-year randomized controlled trials (RCTs) and narrative review on short-term RCTs. Obes Rev. 2013; 14(5):383-92.

ACPE UAN#0100-0000-14-50-H01-P

Arizona Center for Professional Education

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

Visit www.azpharmacy.org

CONTINUING EDUCATION

NEW RULES FOR CPE MONITOR REPORTING The Arizona Pharmacy Association, an ACPE-accredited provider of continuing pharmacy education, announces new rules regarding reporting of CEUs to the NABP eProfile ID/CPE Monitor data base.

Effective May 1, 2014 all ACPE-accredited providers have 60 days post the CPE activity participation date to upload the participant credit into CPE Monitor. The provider must upload the participant information 60 days from the date the participant completed the CPE activity. This applies to all CPE activities: live, internet-based, and home-study articles.

To facilitate these new rules and ensure timely upload of all participant credits to CPE Monitor, the following changes apply to the issuance of continuing education credits by the Arizona Pharmacy Association.

1. Participant credit will only be awarded upon successful completion of all evaluations and/or post-activity assessments.

a. For live activities (except certificate training programs), participant must complete the online evaluation form within two weeks after the date of the live activity. For example, for all continuing education activities attended at the 2014 AzPA Annual Convention, online evaluation forms must be submitted by July 6, 2014.

b. For certificate training programs, participant must complete the online evaluation forms and post-activity assessments for both the self-study and live session within two weeks after the date of the live session.

c. For home-study articles (i.e., those published in the Arizona Journal of Pharmacy), post-activity quiz and evaluation must be submitted prior to the expiration date of the activity.

2. Paper statements of credit will no longer be issued. All credit awarded by ACPE-accredited providers to pharmacists and pharmacy technicians must be via CPE Monitor. If participants would like a paper statement of credit, they may print an individual statement of credit or a transcript from their NABP e-profile.

Make sure you give correct information regarding birthdates and NABP eProfile #’s on all form fields when registering for a CE activity. It is the responsibility of every CE participant to give the provider the correct information or CE credits will not be recorded on your NABP eProfile!

All continuing pharmacy education credits awarded by the Arizona Pharmacy Association will be uploaded within 60 days of the completion of the activity. Please monitor your NABP eProfile account for accuracy. If you have any questions, please contact Kathy Harty at kathy@azpharmacy.org or 480-838-3385.

Fall 2014 • Arizona Journal of Pharmacy • 37

CONTINUING EDUCATION

Geriatric Patient Care by U.S. Pharmacists in Healthcare Teams: Systematic Review and Meta-Analyses

By: Jeannie K. Lee, PharmD,a Marion K. Slack, PhD,a Jennifer Martin, MA,b Clara Ehrman, BS,a and Marie ChisholmBurns, PharmD, MPH,c (aPharmacy Practice and Science, College of Pharmacy, Univ of Arizona bInformation Services, Arizona Health Sciences Library, University of Arizona, cCollege of Pharmacy, Univ of Tennessee Health Science Center) OBJECTIVES: To conduct a systematic review and meta-analyses to examine the effects of pharmacists’ care on geriatric patient-oriented health outcomes in the United States.

DESIGN: Studies examining U.S. pharmacists’ patient care services from inception of the databases through July 2012 were searched. The databases searched include PubMed/MEDLINE, Ovid/MEDLINE, ABI/INFORM, Health Business Fulltext Elite, Academic Search Complete, International Pharmaceutical Abstracts, PsycINFO, Cochrane Database, and ClinicalTrials.gov.

Studies reporting pharmacists’ intervention for geriatric patients, comparison groups, and patient-oriented outcomes were assessed. Dual review for inclusion and data extraction were performed.

SETTING: University of Arizona College of Pharmacy MEASUREMENTS: Study and participant characteristics, pharmacist intervention, and outcomes with data for meta-analyses were collected. A forest plot was constructed to obtain a pooled standardized mean difference using a random effects model.

RESULTS: One hundred fifty-two articles were reviewed, with 20 resulting studies included in the final meta-analyses. Study sample size ranged from 36 to 4,218, with mean age of subjects of 65 and older. The studies were most frequently conducted in ambulatory care clinics, followed by inpatient settings; the majority focused on multiple diseases and conditions.

Pharmacist activities varied widely, with technical interventions used most often. Favorable results were found in all outcome categories, and meta-analyses conducted for therapeutic, safety, hospitalization, and adherence were significant (p<.001), favoring pharmacist care over comparison. Some identifiable variability existed between included studies.

The United States is aging along with the rest of the world, especially now that the baby boomers are turning 65 years and growing older, meaning that the patient population is aging and that an increasing number of older adults require polypharmacy management for their chronic conditions. Polypharmacy means using multiple medications concurrently, which is common in older individuals, with more than one-third using five to nine medications and 12% using 10 or more.1 Adverse drug effects occur in high rates in the United States (>4.5 million each year) and frequently affect older adults in primary care and long-term care settings; many are preventable.2,3 Older adults are particularly vulnerable to experiencing adverse drug reactions or events when potentially inappropriate medications, as defined according to the Beers Criteria, are used.4–6 High healthcare costs in older adults stem from use of the inappropriate medications—$7.2 billion in 2000/01 healthcare expenditures.7 In 2008, the Institute of Medicine (IOM) released Retooling for CONTINUING EDUCATION

an Aging America: Building the Health Care Workforce emphasizing the need to enhance geriatric competencies in healthcare providers who will care for the growing older populations.8 The report also stressed the need to improve and disseminate effective geriatric care models, including interprofessional team care.8 The IOM has also recognized the critical value of pharmacist knowledge and services in medication management and safety and their effect on quality patient care through collaborative practice.9–11 Pharmacists’ medication use expertise and roles as members of healthcare teams are crucial for older adults who use multiple medications including multiple over-the-counter medications, supplements, and herbal products.12 A previous systematic review and meta-analysis has reported the value of U.S. pharmacists as members of healthcare teams to improve patient-oriented health outcomes,13 illustrating the benefit of having pharmacists as team members providing direct patient care on therapeutic, safety, and humanistic health outcomes in the U.S.13 but there is a knowledge gap concerning the effect of pharmacist intervention on geriatric patient outcomes. Pharmacists involved in geriatric care are often uniquely trained in therapeutics and provide medication therapy management to ensure the provision of safe and effective pharmacotherapy for older adults. These geriatric pharmacists often serve as valuable members of the interprofessional geriatric teams, collaborating to maximize medication benefit and minimize adverse drug effects. A comprehensive systematic review and meta-analysis can strengthen the evidence regarding U.S. pharmacists providing direct care to older adults.

Thus, the overall objective of this study was to conduct a systematic review and meta-analysis to examine the effects of U.S. pharmacist interventions on older adults and resulting patient-oriented outcomes.

METHODS: Study Selection To be included in the data extraction process, studies were required to present all of the following: evidence of pharmacist intervention (able to discern pharmacist contribution), analytical data (statistical evaluation of pharmacist intervention), comparison group, objective patient-related health outcomes,

Geriatric Patient Care and study subjects aged 65 and older. Along with duplicate references, the following types of studies were excluded: non-U.S. studies, clinical drug trials, case studies, systematic reviews, meta-analyses, and nonresearch articles. Therefore, the studies selected for inclusion and exclusion assessment were randomized controlled trials (RCTs), comparative cohort studies, pre–post studies, and before-and-after studies that evaluated U.S. pharmacist interventions for older populations. To be included in the meta-analysis, studies had to compare the outcomes of a patient-level pharmacist intervention in older adults with those of alternative care. The pharmacist intervention needed to have the intention of improving therapeutic outcomes, reducing hospitalizations, improving safety, or increasing medication adherence. Measures varied depending on the type of outcome being assessed, but the data reported on the measure had to be sufficient to calculate a standardized mean difference (SMD) for the study to be included in the meta-analysis.

Search Strategy Studies conducted in geriatric populations were extracted from the database of studies examining pharmacist services compiled for a systematic review13 that included studies published through January 2009. A medical librarian conducted an updated search from January 2009 to July 2012 using NLM PubMed/MEDLINE (1946), Ovid/MEDLINE (1946), ABI/INFORM (1970), Health Business Fulltext Elite (1922), Academic Search Complete (1887), International Pharmaceutical Abstracts (IPA, 1970), PsycINFO (1800s), Cochrane Database of Systematic Reviews (1898), and ClinicalTrials.gov (2000). The key word terms used in the search strategies were found anywhere in the citation and included older adults, elderly, senior, frail, aged elderly, and aged, in addition to controlled vocabulary for MEDLINE. The reference lists of review articles and meta-analyses were hand-searched to identify any missed studies.

Data Extraction A pharmacist expert in interprofessional geriatric practice led the review. A dual review process was used for study inclusion and data extraction, with a team of two reviewers reviewing studies independently and then meeting to consolidate the data. Previously tested standardized forms were used to minimize variability. Any differences in the consolidated data were identified and resolved by consensus. Data extraction consisted of study and participant characteristics, pharmacist interventions, and participant-level outcomes.

Outcomes and Data Analysis The primary outcome measure was the SMD, which was calculated for each study and then pooled by constructing a forest plot to obtain an estimate of the overall effect of the pharmacist care. Conceptually, the SMD is a measure of the CONTINUING EDUCATION

difference in effect between pharmacist care and the comparison. The size of the SMD can be interpreted as being small (<0.2), moderate (0.2–0.8), or large (>0.8).14 Descriptive and demographic data were summarized by calculating the overall means and standard deviations for continuous data; categorical data were presented with frequencies and percentages. The results were synthesized by constructing a forest plot using a random effects model for each of the four broad categories of outcomes: therapeutic, hospitalization, safety, and adherence. A random-effects model includes withinand between-study variability.15 Because the analyses included various types of pharmacist intervention and multiple outcome measures, it was assumed there would be variation in the outcomes between the studies. To assess this variability, the I2 measure, which reports the percentage of variability due to factors other than random variation (the studies are functionally different because of differences in, e.g., source population, type, and intensity of treatment) were used. In general, an I2 of less than 25% is considered to indicate that nonrandom variation is negligible, approximately 50% is moderate, and greater than 70% is substantial.

In this study, if I2 was greater than 70%, the studies were stratified to reduce I2 to less than 70% within each outcome category.16 Funnel plots and Kendall’s tau were used to assess publication bias. A classic fail-safe N, the number of studies showing no effect that would be needed to increase the p-value to more than .05, was also calculated. All data analysis was performed using Comprehensive Meta-analysis Program (Biostat, Englewood, NJ) software.

Because studies were not required to have a RCT design, standard tools for assessing potential for bias (e.g., the Jadad scale17) could not be used because they primarily assess randomization or factors related to randomization. Therefore, potential for bias was assessed using the standard hierarchy of research design adapted from the Scottish Intercollegiate Guidelines Network,18 in which RCTs are assumed to have the least potential for bias, followed by studies having prospective cohort, pre–post, before-and-after (the before group is a historical control), and retrospective cohort designs. Studies were also grouped according to study design and the SMD between RCTs and other designs was compared to determine whether study design was associated with the magnitude of outcome measure.

RESULTS: Characteristics of Included Studies Titles and abstracts of 1,431 studies from the updated literature search (2009–2012) were reviewed for exclusion, followed by a review of 127 abstracts and full-text articles for inclusion in the systematic review.

With 25 studies identified from the previously published Fall 2014 • Arizona Journal of Pharmacy • 39

Geriatric Patient Care study,13 152 studies were reviewed and data extracted for meta-analyses when appropriate. The resulting 20 articles (7 from the updated search and 14 from the previous study13) were included in the final meta-analyses (Figure 1). Table 1 shows characteristics of the studies included in the meta-analyses. There were six RCTs,22,26,29–31,34 four prospective cohort studies,20,21,24,32 five pre–post studies,23,25,35–37 two before-and-after studies,27,38 and three retrospective cohort studies.19,28,33 Study sample size ranged from 36 in a before-and-after study38 to 4,218 in a retrospective cohort study,19 with the mean age of all study subjects being 65 and older. As expected, the vast majority of participants were male in the Veterans Affairs and Department of Defense settings, whereas female participants were the majority in other study settings. Disease or condition targeted by pharmacist interventions varied, with the majority (9 studies20,23–25,27,29,31,35,37) focused on multiple diseases and conditions. Table 2 depicts practice setting and pharmacist intervention in detail. The studies were most frequently conducted in ambulatory care clinic (6 studies21,26,28,30,33,34), followed by an inpatient setting (5 studies20,23,29,31,32). Assuming all participants had health insurance through Medicare, presence and types of supplemental insurance varied between the studies.

Pharmacist activities varied widely, with technical interventions used in almost all studies (18 studies19–24,26–28,30–38), although several studies used them in combination with other interventions. 20–22,24,26,30,31,35 The outcome variables were grouped into therapeutic, safety, hospitalization, and adherence categories.

Therapeutic Outcomes The forest plot for therapeutic outcomes, displaying sample size and level of evidence, is shown in Figure 2. The total sample size was 2,376, and the overall SMD was large (–0.81, p <0.001), but variability between studies as indicated by I2 was very high (89%), signifying that there were functional differences between studies. SMDs ranged from –0.0433 to –1.35;28 the next largest SMD was –0.68.37 Stratifying the studies into functional groups (Groups A and B in Figure 2) so that the study with the very large effect28 was separated from the remainder, reduced the I2 to 11.2% for the other seven studies. Thus, the overall SMD for the group of seven studies that could be considered typical studies was –0.36 (p <0.001), a moderate effect size. The pooled mean difference was –0.43 (p = 0.001) for the RCTs and –0.22 (p =.04) for the remaining five studies; the mean difference was 51% greater for the RCTs, although the comparison was not statistically significant (p =.20). The mean difference varied between 0.1437 with international normalized ratio (INR) as outcome to 0.5832 with antibiotic therapy change as outcome. The mean difference was not statistically CONTINUING EDUCATION

significant for the smallest study with glycosylated hemoglobin as outcome (N = 36, SMD = –0.56)38 or the largest study with mortality as outcome (N = 521, SMD = –0.45).24 Only two studies (N = 159, outcome = systolic blood pressure (SBP);30 N = 118, outcome = antibiotic therapy change32) had statistically significant mean differences (p <.001 and p =.05, respectively). The two studies reporting the smallest mean differences and used a retrospective design and mortality as outcome measure (SMD = –0.1437) and a pre–post design and therapeutic INR as an outcome measure (SMD = –0.0433). Publication bias was not a problem with nonsignificant Kendall’s tau (p =.21), and there was no evidence of bias in the funnel plot.

The classic fail-safe N was 150, indicating that 150 studies with no effect would be required to increase the p-value to more than .05.

The SMD for the single study reporting a large effect was –1.35, which was significantly greater than the overall SMD (–0.36) for the other seven studies (p < 0.001).28 This study used retrospective database cohorts and involved women treated for osteoporosis in an integrated health system in two different regions. One region used clinical pharmacists to follow up with women aged 67 and older who had a fracture; the second region used a nurse to perform similar follow-up. Differences in provider regions, in the services provided, and how the data were extracted could have contributed to the difference in outcomes.

Safety Outcomes The forest plot for the studies examining the effect of pharmacist care on safety is shown in Figure 2. The total sample size was 5,732; the overall SMD was –0.33 and was statistically significant (p < 0.001). The SMD for the Figure 1. Meta-analysis inclusion/exclusion flowchart.

Included full text from Chisholm-Burns et al. (n= 334) Extracted full text with intervention in older adult patient population (n= 25)

25 Abstracts and full text were subjected to inclusion and exclusion assessment using meta-analysis inclusion tool

Updated Literature Search conducted and titles/abstracts identified in literature searches (n= 1,431) Excluded abstracts and full text (n= 1,304)  No evidence of pharmacists’ involvement in service or intervention  Not analytical and interventional in nature  No comparison group present  No objective patient-related outcomes 127 Abstracts and full text were subjected to inclusion and assessment using meta-analysis inclusion tool

Total studies assessed = 152 Excluded full text (n= 132)  No data to use in meta-analysis  Included patients ≤65years  Economic outcomes only  Not patient-level outcome (hospital level) Total studies in meta-analyses = 20 (7 from updated literature search)

Geriatric Patient Care three RCTs was –0.21 (p = .04); for the seven studies of other designs, the pooled mean difference was –0.37 (p < 0.001), which was not statistically different from the RCTs (p =.18). The mean difference varied between –0.0222 and –1.05.33 Most studies used change in number of medications as outcome,19,21,25,36,37,38 two studies used adverse drug events,26,33 and two studies used number of falls.22,27 There was minimal variability (I2 = 30%, p =.17) between the studies. There was no evidence of publication bias in the funnel plot, and Kendall’s tau was not significant (p = .88). The classic fail-safe N was 215, indicating that 215 studies showing no effect would be needed to negate this effect.

Hospitalization Outcomes The forest plot for hospitalization is shown in Figure 2.

The total sample size was 2,406, and the overall SMD was moderate (–0.33) and statistically significant (p = .01), although variability between studies as I2 indicated was high (74%), demonstrating that there were functional differences between the studies. Examination of the SMDs revealed that one study reported results favoring the comparison rather than pharmacist care.24 Stratifying the studies into functional groups (Groups A and B in Figure 2) so that the study with the opposite result was separated, reduced the I2 to 0% (meaning no nonrandom variation) between the remaining studies. The mean difference for the RCTs (–0.38, p =.22) was approximately 24% greater than for overall mean difference (–0.31, p =.03) for the studies with other designs, although this difference was not statistically significant (p =.82).There was no evidence of publication bias; Kendall’s tau was not significant (p =.85), and there was no evidence of bias in the funnel plot. The classic fail-safe N was 39, indicating that 39 studies showing no effect would be needed to increase the p-value to more than .05.

The SMD for the single study reporting a result that favored the comparison was 0.2624 and was significantly different (p < 0.001) from the overall SMD (–0.41) for the other studies. This study used a prospective cohort design to compare individuals discharged to home from a skilled nursing facility with rehospitalization as outcome. Patients in the pharmacist care group were those with discharge summaries sent to the pharmacy within 48 hours of discharge. The comparison group consisted of individuals whose discharge summaries a chronic care coordinator nurse received after 48 hours. Although the individuals in the pharmacist-run medication reconciliation program were more likely to be rehospitalized, there was no difference in the rate of death (5.9% vs 2.7%; NS), suggesting that the hospitalizations were for legitimate health needs. Therefore, the need for hospitalization may have been recognized more often in the pharmacist care group than the usual care group, or there was a CONTINUING EDUCATION

difference in the need; the reason for the difference could not be discerned in this analysis.

Adherence Outcomes The forest plot for adherence is shown in Figure 2. There were four RCTs26,30,31,34 and one database study.28 The total sample size was 981, with a SMD of –0.78, a large effect size (p <0.001), but the variability as identified by I2 was very high (93.7%), indicating that there were functional differences between studies. Examination of the mean differences showed that they varied between –2.09 and –0.04, with all studies favoring pharmacist care, although only two studies30,34 produced statistically significant findings. When the study with the very large mean difference (–2.09)30 was placed in a separate stratum, the I2 for the remaining four studies was 12.4%, indicating minimal variability. The overall SMD for this group of studies was –0.36, a moderate effect size. There was no evidence of bias; Kendall’s tau was 1.00, and there was no evidence of bias in the funnel plot. The classic fail-safe N was 150, indicating that 150 studies showing no effect would be needed for nonsignificant result.

One study,30 a RCT that used a comprehensive pharmacy care program consisting of a multicomponent intervention including individualized medication education with regimen customizing by pharmacists, blister-packed medications for convenience and cue, and serial follow-up with pharmacists every 2 months, had a very large SMD (–2.09). The intensive design of the intervention may have heightened the effect on the adherence outcome. Although it was not the only study targeting polypharmacy, it was the only study that blister-packed all chronic medications for its subjects.

DISCUSSION “Successful models of comprehensive care for older adults with chronic conditions” were identified39 to provide evidence for the IOM report “Retooling for an Aging America.”8 Among the reported models of care, the majority provided comprehensive care by interdisciplinary teams, including pharmacists, beyond a primary care provider.39 This report called for payment reform by the Centers for Medicare and Medicaid Services to pay for care by the ancillary providers, including nurses, pharmacists, and social workers, to promote the interdisciplinary care models and to make them mainstream in older American healthcare.39 Therefore, it is essential to evaluate the effects of pharmacist care on health outcomes of older adults in the United States.

To the knowledge of the authors, this is the first systematic review and meta-analysis to examine the effect of U.S. pharmacist interventions on health outcomes within healthcare teams serving older adults.

Upon systematic review of the literature, there were Fall 2014 • Arizona Journal of Pharmacy • 41

Geriatric Patient Care enough data to perform meta-analyses on four patient-oriented outcomes: therapeutic, safety, hospitalization, and adherence. The most important finding of this study is that pharmacist care produced significantly higher benefit over comparative care for all outcome areas. The effect (overall SMDs) was remarkably consistent between the studies forming functionally homogeneous groups; the SMDs were –0.36 for the therapeutic and adherence outcomes, –0.37 for the safety outcome, and –0.41 for the hospitalization outcome. Although several international reviews or systematic reviews of pharmacist care and their effect on older adults were performed previously, none specifically addressed U.S. pharmacists, and all targeted narrow aims concerning health outcomes.40–45 For example, two studies focused on optimization of pharmacotherapy in older individuals40,43 and one each on reducing polypharmacy in older people,45 suboptimal prescribing in elderly adults,42 medication review to reduce hospitalization and deaths in older adults,44 and medication reconciliation during long-term care transition.41 In comparison, the current systematic review and meta-analyses targeted broader categories of older adult–oriented health outcomes, including therapeutic, safety, hospitalization, and adherence outcomes.

As expected, variability existed between included studies in the current study concerning study population and setting, sample size, study design, intervention, outcomes measured, and comparison group. Studies with small sample size may have been underpowered to detect effect on certain health outcomes, and biased selection may have been in place. Although all included subjects were older, there were differences in the source population in terms of possession of supplemental insurance (none to private insurance), which may be indicative of diverse financial and educational background of the included subjects (Table 2). Study setting varied, ranging from home to nursing home (See Table 2).

Study design, ranging from RCTs to retrospective cohort studies, are identified in the forest plots (Figure 2), with RCTs having more-consistent 95% confidence intervals in most outcome categories than studies with other designs. Type and intensity of the intervention differed widely, although studies using the most-intense interventions did not result in consistently higher effects. For example, two studies used behavioral plus educational plus technical interventions26,30 for adherence outcomes that resulted in small (SDM = –0.04)26 and large (SDM = –2.09)30 effect sizes. Six studies used educational plus technical interventions20–22,24,31,35 for various outcome categories and resulted in varying degrees of SMDs. CONTINUING EDUCATION

Table 1. Characteristics of Included Studies Study Author, Year

Design

Total Na

Male, %

Disease or Condition

Outcome Category

Outcome used in metaanalysis

4,218

Patient Age, Mean±Standard Deviationb 77.1±6.2

Aspinall et al., 201119

Retrospective cohort

99.5

Safety

Discontinuation of glyburide 1st month

Prospective cohort Prospective cohort RCT

543

82±13

NR

Diabetes mellitus, renal insufficiency Multiple

Badger et al., 200720 Blakey et al., 200021 Blalock et al., 201022

Hospitalization

LOS

250

NR

NR

Safety

186

75.5±7.0

29

Mean number of drug reductions Falls (intention-to-treat analysis)

Dedhia et al., 200923 Delate et al., 200824 Hammarlund et al., 198525 Hanlon et al., 199626 Haumschild et al., 200327 Heilmannet al., 201228

Pre–post

422

76.7±7.7

39

Geriatric syndrome Falls, polypharmacy, central nervous system medication Multiple

Hospitalization

Readmission at 30 days

Prospective cohort Pre–post

521

78.7±9.3

37

Multiple

Readmission, death

39

77

23

Multiple

Hospitalization, therapeutic Safety

RCT

169

69.7±3.5

99

Polypharmacy

Safety, adherence

Before-andafter Retrospective cohort

400

78.5

36

Multiple

Safety

1,129

77.5±7.7

NR

Osteoporosis

Therapeutic, adherence

Koehler et al., 200929 Lee et al., 200630

RCT

41

77.2±5.3

27

Multiple

Hospitalization

RCT

159

78±8.3

74

Polypharmacy, hypertension

Adherence, therapeutic

Medication adherence, SBP

Lipton et al., 199431 Pastel et al., 199232 Poon et al., 200733

RCT

206

NR

NR

Multiple

Adherence

Medication adherence

Prospective cohort Retrospective cohort

101

67.3±1.5

45

Infection

Therapeutic

206

80.6±3.7

99

Anticoagulation

Safety, therapeutic

Schneider et al., 200834 Smith et al., 200635 Suhrie et al., 200936 Thompson et al., 198437

RCT

85

NR

49

Hypertension

Pre–post

740

76±6.9

17

Multiple

Adherence, therapeutic Hospitalization

Antibiotic treatment course modified Thromboembolic event, therapeutic international normalized ratio Medication adherence, SBP Hospitalization

Pre–post

89

79.7±7.8

98

Palliative care

Safety

Pre–post

139

85.8±7.9

17

Multiple

Tsai et al., 198238

Before-andafter

36

81.5

19

Anemia, malnutrition, chronic disease

Safety, hospitalization, therapeutic Safety, therapeutic

a

Safety

Total number of participants in comparative groups.

Intervention group participants if no total age reported.

NR = not reported, LOS = length of stay, RCT = randomized controlled trial, SBP = systolic blood pressure.

Number of prescriptions taken Adverse drug event, medication adherence Falls Osteoporosis med or bone mineral density screening, medication adherence LOS

Number of unnecessary medications Mean number of drugs, hospitalization, death Number of scheduled drugs, serum hemoglobin

b

There was a difference in type of outcome measured, with the majority of studies focused on surrogate (e.g., adherence) and intermediate (e.g., SBP) outcomes, with only a few studies evaluating change in health status (e.g., mortality). Even within an outcome category, there were different measures, such as SBP, therapeutic INR and death, within the therapeutic outcome category. Additionally, methods used to assess outcomes varied, such as pill count versus self-report for medication adherence. For example, one study used pill counts as the adherence measure, which was performed every 2 months in person, rather than self-report or refill history after a longer time period, which may have influenced the study subjects to be more vigilant about taking their medications.30 Hospitalization was measured using several methods also, including number of hospitalizations,35,37 length of stay,20,29 and readmission rate.23,24 Lastly, type of comparison care was often unclear ‘usual care’ with a lack of control of the additional attention that subjects in the intervention group would have received.

Despite the variability associated with the current meta-analyses, the benefit of pharmacist intervention in older adult care is evident. As healthcare reform occurs in the US, with team-based care being implemented in diverse treatment settings, having a pharmacist member on the teams serving older adults will be crucially important for demonstrating better patient-oriented outcomes.

CONCLUSION Based on the findings from this study, which shows a positive effect of pharmacists on therapeutic, safety, hospitalization, and adherence outcomes, older adults should receive teambased care including pharmacist direct patient care services.

Geriatric Patient Care

1 Functional Group

Table 2. Practice Setting and Pharmacist Interventions Study Author, Year

Setting

Insurance Typea

Intervention Typeb

Pharmacist Activities

Aspinallet al., 201119 Badger et al., 200720 Blakey et al., 200021 Blalock et al., 201022 Dedhiaet al., 200923 Delate et al., 200824

Outpatient

VA

Technical

Inpatient

NR

Ambulatory clinic Community pharmacy Inpatient

VA

Technical, educational Technical, educational Educational, technical Technical

Therapeutic change for patients at increased risk of hypoglycemia with glyburide use and renal insufficiency Medication reconciliation, therapeutic change, interdisciplinary rounds, patient education DRP detection and resolution by therapeutic change

Hammarlund et al., 198525 Hanlon et al., 199626

Health maintenance organization Home

Medicare, Private Medicare, Private Medicare, Private

Educational, technical

Standardized face-to-face medication consultation with emphasis on fall risk; therapeutic changes Medication reconciliation, therapeutic change, collaboration with hospitalist Medication reconciliation, DRP resolution by therapeutic change, collaboration with discharge provider and/or PCP, educate patients

NR

Educational

Ambulatory clinic

VA

Rehabilitation center Ambulatory clinic

NR

Behavioral, educational, technical Technical

Private

Technical

Koehler et al., Inpatient, home 200929 Lee et al., 200630 Ambulatory clinic

NR

Educational

Department of Defense

Lipton et al., 199431

Inpatient, office, home

Medicare, California Medicaid

Behavioral, educational, technical Educational, technical

Pastel et al., 199232 Poon et al., 200733 Schneider et al., 200834 Smith et al., 200635 Suhrieet al., 200936 Thompson et al., 198437 Tsai et al., 198238

Inpatient

NR

Technical

Empirical antibiotic streaming

Ambulatory clinic Ambulatory clinic Program office, home Nursing home

VA

Technical

Anticoagulation management

NR

Technical

Lisinopril in daily-dose blister packaging

Medicare

Educational, technical Technical

Medication payment assistance, medication therapy management

Skilled nursing facility Skilled nursing facility

California Medicaid Medicaid

Technical

Medication prescribing, changing, discontinuing based on patient data and physical findings Monthly rounds, medication reconciliation and error detection

Haumschild et al., 200327 Heilmannet al., 201228

VA

Technical

Medication evaluation, therapeutic change for fall reduction Communication to primary care provider—bone mineral density screening, initiation of osteoporosis therapy or calcium and vitamin D supplementation Medication reconciliation and education, postdischarge telephone follow-up Standardized medication regimen tailoring and education, blisterpacked medications for adherence, serial follow up

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3. Gurqitz JH, Field TS, Judge J et al. The incidence of adverse drug events in two large academic long-term care facilities. Am J Med 2005;118:251–258.

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12. Rollason V, Vogt N. Reduction of polypharmacy in the elderly. A systematic review of the role of the pharmacist. Drugs Aging 2003;20:817–832.

13. Chisholm-Burns MA, Kim Lee J, Spivey CA et al. US pharmacists’ effect as team members on patient care: Systematic review and meta-analyses. Med Care 2010;48:923–933.

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18. Scottish Intercollegiate Guidelines Network (SIGN). SIGN 50: A Guideline Developers’ Handbook 2000 [on-line]. Available at: www.sign.ac.uk/guidelines/fulltext/50/

Total N

Statistics for each study Std diff Lower Upper in means limit limit

A A A A A A A A B B

Schneider, 2008 Lee, 2006 Delate, 2008 Pastel, 1992 Poon, 2007 Thompson, 1984 Tsai, 1982 Overall Heilmann, 2012 Overall Overall

85 159 521 101 206 139 36

1 1 2 2 2 2 4

2376

1129

5

A A A A A A A A A A

Blalock, 2010 S Hanlon, 1996 Haumschild, 2003 Blakey, 2000 Hammarlund, 1985 Poon, 2007 Suhrie, 2009 Thompson, 1984 Tsai, 1982 Aspinall, 2011 S Overall

186 169 400 250 39 206 89 139 36 4218 5732

1 1 1 2 2 2 2 2 4 5

A A A A A A B B

Koehler, 2009 Thompson, 1984 Smith, 2006 Badger, 2007 Dedhia, 2009 Overall Delate, 2008 Overall Overall

41 139 740 543 422

1 2 3 4 4

521

2

-0.32 -0.50 -0.45 -0.58 -0.04 -0.68 -0.56 -0.36 -1.35 -1.35 -0.81

-0.75 -0.81 -1.12 -1.17 -0.34 -1.42 -1.24 -0.54 -1.55 -1.55 -0.94

-0.02 -0.24 -0.39 -0.51 -0.27 -1.05 -0.32 -0.14 -0.03 -0.43 -0.33

- 0.34 0.30 - 0.59 0.11 - 0.74 -0.04 - 0.76 -0.25 - 0.59 0.05 - 1.90 -0.21 - 0.54 -0.11 - 0.47 0.19 - 0.70 0.64 - 0.55 -0.31 - 0.44 - 0.22

Std diff in means and 95% CI

Z-Value p-Value

0.11 -1.44 -0.18 -3.07 0.22 -1.32 0.01 -1.93 0.26 -0.24 0.06 -1.81 0.12 -1.61 -0.17 -3.79 -1.15 -13.17 -1.15 -13.17 -0.67 -11.68

0.15 0.00 0.19 0.05 0.81 0.07 0.11 0.00 0.00 0.00 0.00

-0.15 -1.34 -2.16 -3.89 -1.65 -2.44 -2.98 -0.82 -0.09 -7.09 -5.83

0.88 0.18 0.03 0.00 0.10 0.01 0.00 0.41 0.93 0.00 0.00

Hospitalization

Drug regimen review, therapeutic change, patient education, post2 discharge phone, office or home follow-up

Application of unnecessary drug use measurec

Study

c bEvidence Level

Safety

Occasional medication counseling and 2 talks on proper use of medications Medication Appropriateness Index assessment, DRP detection and resolution by therapeutic change, patient education, adherence cues

VA = Veterans Affairs, NR = not reported, DRP= drug-related problems. a Medicare assumed for all participants because elderly population; insurance type reported by the study noted here. b Definition of pharmacist intervention categories: educational (focuses on teaching and providing knowledge related to the patient’s medical condition and medication regimen); behavioral (attempts to modify patient behaviors through the use of cues, reminders, or reinforcement); technical (addresses the medication regimen; strategies include therapeutic change or interchange, simplifying the dosing regimen or schedule, and the use of tools such as pillboxes); and combination or multimodal (uses strategies from more than one of the above 3 categories (technical, educational, and behavioral)) c Lack of indication, lack of effectiveness, and therapeutic duplication.

CONTINUING EDUCATION

Therapeutic dd

a

2406

-0.38 -0.95 -0.37 -0.55 -0.30 -0.41 0.26 0.26 -0.33

-1.00 -1.83 -0.53 -0.78 -0.58 -0.53 -0.05 -0.05 -0.44

0.23 -0.07 -0.22 -0.31 -0.01 -0.30 0.58 0.58 -0.23

-1.22 -2.13 -4.68 -4.57 -2.06 -7.04 1.63 1.63 -6.04

0.22 0.03 0.00 0.00 0.04 0.00 0.10 0.10 0.00

-0.47 -0.51 -0.04 -0.47 -0.36 -2.09 -2.09 -0.78

-0.90 -1.18 -0.43 -0.78 -0.58 -2.48 -2.48 -0.97

-0.04 -2.13 0.16 -1.48 0.35 -0.20 -0.15 -2.93 -0.14 -3.16 -1.70 -10.59 -1.70 -10.59 -0.59 -8.00

0.03 0.14 0.84 0.00 0.00 0.00 0.00 0.00

S

Adherence

t A A A A A B B

Schneider, 2008 Lipton, 1994 Hanlon, 1996 Heilmann, 2012 Overall Lee, 2006 Overall Overall

85 206 169 362

1 1 1 5

159

1

981

u d y

-2.00

-1.00

0.00

Favors Pharmacist Care

1.00

2.00

Favors Comparison

Figure 2.

section6.html Accessed February 15, 2009.

19. Aspinall SL, Zhao X, Good CB et al. Intervention to decrease glyburide use in elderly patients with renal insufficiency. Am J Geriatr Pharmacother 2011;9:58–68.

20. Badger N, Mullis S, Butler K et al. Pharmacist’s intervention for older hospitalized patients. Am J Health Syst Pharm 2007;64:1794–1796.

21. Blakey SA, Hixson-Wallace JA. Clinical and economic effects of pharmacy services in geriatric ambulatory clinic. Pharmacotherapy2000;20:1198–1203.

22. Blalock SJ, Casteel C, Roth MT et al. Impact of enhanced pharmacologic care on the prevention of falls: A randomized controlled trial. Am J Geriatr Pharm 2010;8:428–440.

23. Dedhia P, Kravet S, Bulger J et al. A quality improvement intervention to facilitate the transition of older adults from three hospitals back to their homes. J Am Geriatr Soc 2009;57:1540–1546.

24. Delate T, Chester EA, Stubbings TW et al. Clinical outcomes of a homebased medication reconciliation program after discharge from a skilled nursing facility. Pharmacotherapy 2008;28:444–452.

25. Hammarlund ER, Ostrom JR, Kethley AJ. The effects of drug counseling and other educational strategies on drug utilization of the elderly. Med Care 1985;23:165–170.

26. Hanlon JT, Weinberger M, Samsa GP et al. A randomized, controlled trial of a clinical pharmacist intervention to improve inappropriate prescribing in elderly outpatients with polypharmacy. Am J Med 1996;100:428– 437.

27. Haumschild MJ, Karfonta TL, Haumschild MS et al. Clinical and economic outcomes of a fall-focused pharmaceutical intervention program. Am J Health Syst Pharm 2003;60:1029–1032.

28. Heilmann RM, Friesleben CR, Billups SJ. Impact of a pharmacist-directed intervention in postmenopausal women after fracture. Am J Health Syst Pharm 2012;69:504–509.

29. Koehler BE, Richter KM, Youngblood L et al. Reduction of 30-day postdischarge hospital readmission or emergency department (ED) visit rates in high-risk elderly medical patients through delivery of a targeted care bundle. J Hosp Med 2009;4:211–218.

30. Lee JK, Grace KA, Taylor AJ. Effect of a pharmacy care program on medication adherence and persistence, blood pressure, and low-density lipoprotein cholesterol: A randomized controlled trial. JAMA 2006;296:2563– 2571.

31. Lipton HL, Bird JA. The impact of clinical pharmacists’ consultations on geriatric patients’ compliance and medical care use: A randomized controlled trial. Gerontologist 1994;34:307–315.

32. Pastel DA, Chang S, Nessim S et al. Department of pharmacy-initiated Fall 2014 • Arizona Journal of Pharmacy • 43

Geriatric Patient Care program for streamlining empirical antibiotic therapy.

Hosp Pharm 1992;27:596–603, 614.

33. Poon IO, Lal L, Brown EN et al. The impact of pharmacist-managed oral anticoagulation therapy in older veterans. J Clin Pharm Ther 2007;32:21–29.

34. Schneider PJ, Murphy JE, Pedersen CA. Impact of medication packaging on adherence and treatment outcomes in older ambulatory patients. J Am Pharm Assoc 2008;48:58–63.

35. Smith SR, Catellier DJ, Conlisk EA et al. Effect on health outcomes of a community-based medication therapy management program for seniors with limited incomes. Am J Health Syst Pharm 2006;63:372–379.

36. Suhrie EM, Hanlon JT, Jaffe EJ et al. Impact of a geriatric nursing home palliative care service on unnecessary medication prescribing. Am J Geriatr Pharmac 2009;7:20–25.

37. Thompson JF, McGhan WF, Ruffalo RL et al. Clinical

pharmacists prescribing drug therapy in a geriatric setting: outcome of a trial. J Am Geriatr Soc 1984;32:154–159.

38. Tsai AE, Cooper Jr. JW, McCall CY. Pharmacist impact on hematopoietic and vitamin therapy in a geriatric long-term care facility. Hosp Formul 1982;17:225–226.

39. Boult C, Green AF, Boult LB et al. Successful models of comprehensive care for older adults with chronic conditions: Evidence for the Institute of Medicine’s “Retooling for an Aging America” report. J Am Geriatr Soc 2009;57:2328–2337.

40. Spinewine A, Fialova D, Byrne S. The role of the pharmacist in optimizing pharmacotherapy in older people. Drugs Aging 2012;29:495–510.

41. Chhabra PT, Rattinger GB, Dutcher SK et al.

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43. Verrue Cl, Petrovic M, Mehuys E et al. Pharmacists’ interventions for optimization of medication use in nursing homes: A systematic review. Drugs Aging 2009;26:37–49.

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A systematic review and meta-analysis. Br J Clin Pharmacol 2008;65:303–316.

45. Rollason V, Vogt N. Reduction of polypharmacy in the elderly: A systematic review of the role of the pharmacist. Drugs Aging 2003;20:817–832.

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

ACPE UAN#0100-0000-14-051-H04-P

CONTINUING EDUCATION QUIZ QUESTIONS

Geriatric Patient Care by U.S. Pharmacists in Heathcare Teams: Systematic Review and Meta-Analyses ACPE UAN#0100-0000-14-051-H04-P 1. What was the purpose of this study? a. To conduct a systematic review and meta-analyses of the US pharmacists’ impact on underserved patients b. To conduct a systematic review and meta-analyses of US pharmacists’ effects on patients who are hospitalized c. To conduct a systematice review and meta-analyses of US pharmacists’ impact on nursing home patients d. To conduct a systematic review and meta-analyses of US pharmacists’ effects on geriatric patient care 2. Which of the following is NOT part of the data collected in this study? a. Cost avoidance of the intervention b. Pharmacist intervention c. Health outcomes d. Patient characteristics 3. What was the mean age of the subjects in the studies included in this systematic review and meta-analyses? a. 60 years and older b. 65 years and older c. 70 years and older d. 75 years and older 4. Which outcome categories were included in the meta-analyses? a. Therapeutic, Safety, Hospitalization, Adherence b. Thereapeutic, Humanistic, Safety, Economic c. Hospitalization, Readmission, Emergency Department Visit, Clinic Visit d. Adherence, Patient Satisfaction, Quality-of-Life, Disease Index CONTINUING EDUCATION

5. Presence of which of the following data was NOT required for a study to be included in this systematic review? a. Description of pharmacist role in healthcare team b. Evidence of pharmacist intervention c. Comparison group d. Patient-related health outcomes 6. Which of the following types of intervention was most often provided by the pharmacist to geriatric patients? a. Educational b. Behavioral c. Affective d. Technical 7. Which diseas or conditions were most often targeted by the pharmacist intervention? a. Endocrine disorders b. Gastrointestinal disorders c. Multiple comorbidities d. Polypharmacy and fall prevention 8. Which of the folloring correctly matched the outcome category and outcome data used in the studies that were included in the meta-analyses? a. Safety - Adverse drug event b. Hospitalization - Falls c. Therapeutic - Readmission d. Adherence - Lifestyle modification

9. The main finding of this systematic review is that pharmacist care for geriatric patients in the US produced significantly higher benefit over comparative care for which of the following outcome areas? a. Therapeutic and Adherence b. Therapeutic and Safety c. Therapeutic, Safety and Hospitalization d. Therapeutic, Safety, Hospitalization and Adherence 10. Identifiable variability existed among the studies included in this systematic review and meta-analyses.

Which of the following statements is true about the study limitation? a. Mean age of the study populations varied from 45 to 85 years b. Types of outcome varied with surrogate and intermediate outcomes used most often c. Study design varied videly but excluded retrospective comparisons d. Patient-oriented outcomes varied but all included studies assessed therapeutic outcomes This activity was developed by the Arizona Pharmacy Association for pharmacists as a knowledge-based learning activity. The Arizona Pharmacy Association is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.

ANSWER SHEET AND EVALUATION FOR THIS HOME-STUDY ACTIVITY ARE ON PAGE 45.

Continuing Education Answer Sheet

I.

Pharmacotherapy for Weight Loss: Magic Bullets or Inevitable Failures ACPE UAN#0100-0000-14-050-H01-P

Activity accredited date: 08/01/2014 Expiration date: 08/01/2017. 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.

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

1. a. b. c. d.

6. a.

2. a. b. c. d.

7. a.

3. a. b. c. d.

8. a.

4. a. b. c. d.

9. a.

5.

a.

b.

c.

d.

10.

a.

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

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.

Geriartic Patient Care by U.S. Pharmacists in Healthcare Teams: Systematic Review and Meta-Analyses ACPE UAN#0100-0000-14-051-H04-P

Activity accredited date: 08/01/2014 Expiration date: 08/01/2017. 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.

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

1. a. b. c. d.

6. a.

2. a. b. c. d.

7. a.

3. a. b. c. d.

8. a.

4. a. b. c. d.

9. a.

5.

a.

b.

c.

d.

10.

a.

Questions on page 44. b. c. d. b. c. d. b. c. d. b. c. d. b.

c.

d.

ACTIVITY EVALUATION – Must be completed to receive credit.

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

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

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 __________________________________________________________ Address ________

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CONTINUING EDUCATION

Fall 2014 • Arizona Journal of Pharmacy • 45

CONTINUING EDUCATION QUIZ QUESTIONS Pharmacotherapy for Weight Loss: Magic Bullets or Inevitable Failures ACPE UAN#0100-0000-14-050-H01-P

1. Which of the following chronic disease states is associated with obesity? a. Sleep apnea b. Hypertension c. Coronary heart disease d. All of the above 2. What was the estimated cost of obesity in 2008? a. $98 million b. $147 million c. $1.4 billion d. $147 billion 3. Which of the following statements is true with regrads to pharmacotherapy for weight loss? a. Pharmacotherapy is indicated in patients who have a BMI > 30 kg/m2 or a BMI > 27 k/m2 with at least 1 additional comorbid disease state b. Pharmacotherapy is first line for the treatment of obesity in all adults with a BMI > 40 kg/m2 c. A sustained weight loss of 10% from baseline body weight is needed before clinically meaningful reductions are seen in comorbid disease states d. Phentermine is approved for the long-term treatment of obesity 4. Which of the following is a side effect associated with phentermine therapy? a. increase heart rate b. diarrhea c. infection d. liver failure 5. What of the following agents is NOT scheduled as a controlled substance in the United States? a. benzphetamine b. orlistat c. phentermine / topiramate d. lorcaserin ANSWER SHEET AND EVALUATION FOR THIS HOME-STUDY ACTIVITY ARE ON PAGE 45.

CONTINUING EDUCATION

6. What was the average mean weight loss compared to placebo that was seen with orlistat in clinical trials? a. 1 kg b. 3 kg c. 5 kg d. 10 kg 7. Which of the following is an important counseling point that should be discussed with a patient who is starting phentermine / topiramate CR? a. Make sure to take this medication with a multiple citamin becasue a side effect is decreased absorption of fat soluble vitamins b. This medication is category X and should not be used during pregnancy c. This medication can cause liver failure d. All of the above are correct statements 8. Which of the following is a common side effect of lorcaserin therapy? a. constipation b. increased blood pressure c. nausea d. insomnia 9. The phentermine / topiramate CR starting dose is phentermine 11.25 mg / topiramate CR 69 mg a. True b. False 10. In the SEQUEL trial, patients were instructed on intensive lifestyle modification inlcuding diet and exercise. a. True b. False

This activity was developed by the Arizona Pharmacy Association for pharmacists as a knowledge-based learning activity. The Arizona Pharmacy Association is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.

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Fall 2014 • Arizona Journal of Pharmacy • 47

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