AJP Spring 2010

ARIZONA JOURNAL A JP OF PHARMACY THE OFFICIAL PUBLICATION OF THE ARIZONA PHARMACY ALLIANCE

SPRING 2010

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ARIZONA JOURNAL A JP OF PHARMACY Vol. 2, No. 1

SPRING 2010

IN THIS ISSUE BOARD OF DIRECTORS PRESIDENT Mark Boesen PRESIDENT-ELECT Kelly Hampton TREASURER Ken Mahan PAST PRESIDENT Linda McCoy SECRETARY Kelly Green Boesen COMMUNITY PHARMACY ACADEMY CHAIR Chad Schuster COMMUNITY PHARMACY ACADEMY CHAIR-ELECT Keith Gallus HEALTH-SYSTEM PHARMACY ACADEMY CHAIR Michael Dietrich HEALTH-SYSTEM PHARMACY ACADEMY CHAIR-ELECT Butch David SENIOR CARE PHARMACY ACADEMY CHAIR Dawn Knudsen SENIOR CARE PHARMACY ACADEMY CHAIR-ELECT Kimberly Cauthon MANAGED CARE PHARMACY ACADEMY CHAIR Kim Kelley MANAGED CARE PHARMACY ACADEMY CHAIR-ELECT Ray Clark TECHNICIAN ACADEMY CHAIR Jenny Whitney TECHNICIAN ACADEMY CHAIR-ELECT Chris Lesaca NORTHWEST DISTRICT DIRECTOR Norbert Laskowski NORTHEAST DISTRICT DIRECTOR Chuck Dutcher SOUTHWEST DISTRICT DIRECTOR Lisa Keller SOUTHEAST DISTRICT DIRECTOR John Nicolais DEANS OF COLLEGES J. Lyle Bootman The University of Arizona College of Pharmacy Dennis McCallian Midwestern University College of Pharmacy Glendale STUDENTS Scott Hall The University of Arizona Mario Rosado Midwestern University INDUSTRY REPRESENTATIVE & LEGAL COUNSEL Roger Morris Quarles & Brady EDITOR’S NOTE: Any personal opinions expressed in this magazine are not necessarily those held by the Arizona Pharmacy Alliance. “Arizona Journal of Pharmacy” (ISSN 1949-0941) is published quarterly by the Arizona Pharmacy Alliance at 1845 E. Southern Avenue, Tempe, AZ 85282-5831. PHONE (480) 838-3385, FAX (480) 838-3557, email info@azpharmacy.org. It is distributed to members as a regular member service paid for through an allocation of dues of $20.00 in advance. Non-member subscription rate is $40.00 per year.

COLUMNS President’s Message 2 CEO’s Message 3 Academy News • Community Pharmacy Academy 15 • Health-System Academy 16 • Managed Care Academy 17 • Senior Care Academy 18 • Technician Academy 19 FEATURES AND ARTICLES The Partnership: Jeff Gray and AzPA Evaluation of Alternative Workflow Models for Implementing a Community Pharmacy-based Immunization Clinic 18th Century English Apothecary Jar Time Capsule

28 29 31 45

DEPARTMENTS New Members 4 Alliance News 6 PAPA News 12 Calendar of Events 12 Legislative Update 13 Drug Information Questions 20 Student Perspective • Leadership: It’s about Passion 22 • Teaming Up for a Unique Experience 23 Feature Pharmacist • Practice Your Passion 24 • Psyched about Pharmacy 25 • Personalized Patient Care 27 Rx and the Law 32 Continuing Education 33 Financial Forum 46 EDITOR-IN-CHIEF Mindy D. Smith, R.Ph., Executive Director/CEO MARKETING AND COMMUNICATIONS Janet Weigel EDITORIAL BOARD Leslie Rodriguez, Pharm.D. Jonathan Merchen, Pharm.D. Whitney Rice, Pharm.D.

Julie Hernandez, Pharm.D. Jennifer Penrose, Pharm.D.

Cover photo: © Cathy Keifer

Arizona Journal of Pharmacy 1

President’s Message An Era of Changes Membership Has Its Privileges Embracing change in this age isn’t particularly easy for anyone. And, unfortunately, our profession is not immune to the financial conditions affecting the world’s economy.

Mark Boesen, Pharm.D. AzPA President

On most days, I feel like the

luckiest guy in the world. I have a wonderful family, a great place to call home, and more friends who care about me than anyone could hope to have. My children, who are six (yes, they’re twins), inspire me to live each day better than the last. I work for a successful organization that has a strong business model and capital to protect it from disasters. I am thankful for all that I have. However, there are bad days. Sometimes I find myself caught up in this new era of change. There are days I have to lend a hand to a close friend or neighbor suffering with unfathomable financial hardships. I’ve seen almost 25% of the homes on my suburban street complete foreclosure auctions and more on the way. I watch hardworking families, just like mine, wonder where their roof will be tomorrow and counsel smart people asking the unanswerable, “What did I do wrong?” On those days, I am even more thankful for my lot in life.

2 Arizona Journal of Pharmacy

I have counseled many of my fellow pharmacists struggling to find work in a profession we once thought “recession proof.” The pharmacy profession, like every other industry, is struggling to survive and provide services for our patients and jobs for our colleagues. I have the privilege of speaking with pharmacists throughout this great State. I’m so proud, and humbled, by the people who elected me to serve as President of this organization. I’m inspired by and learn from the pharmacists and technicians who teach me every day. More often than not, the pharmacists I speak with understand the value of working as a team and investing in the future of pharmacy to prepare it for the future - a future a little more cloudy than in years past. The Arizona Pharmacy Alliance is a special organization. We are called upon to defend the profession for all of its members. During the current legislative session, AzPA was called to the State Capitol to teach the intricacies of oncology services and pharmaceutical reimbursement issues for patients. In addition, we were asked to identify opportunities for federal ftimulus dollars and how those dollars could both enhance patient care services and create jobs for professionals (even pharmacists)

struggling to find work. The executive leadership of the AzPA has been asked to “carry the water” for every sector in our profession and has dedicated staff and volunteers working overtime to assure that we not only survive this era, but excel despite it. The best way for AzPA to be able to continue to “fight the good fight” on your behalf is to increase our membership. We currently have more than 1600 members, but with more than 5800 licensed pharmacists living in the state of Arizona and more than 15,000 pharmacy technicians, we have tremendous potential to grow. Imagine how much greater our influence would be if each current member recruited at least one new member. We would double our numbers and our strength. If you know someone who isn’t an AzPA member, ask them to join. We’ll even reward your efforts (see page 11 for details on the Member-Get-aMember Challenge.) Membership in our organization is an honor, a privilege and a responsibility that we should all take very seriously. Membership in the AzPA is the only real assurance that your future in this profession survives the struggles these past few years have brought to us.

CEO’s Message Embracing Change: What is Good for Patient Care is Good for Business When was the last time you visited a pharmacy as a patient? As a pharmacist or pharmacy technician, you may be surprised by the experience. I know my most recent encounter was extremely eye-opening. Recently, I moved to a new neighborhood. I was going to be out of town for a few days and needed to have a prescription filled before I left. I was not able to contact my regular pharmacy and decided to find a pharmacy close to my new home. Without going into all the details, the bottom line was that I left the pharmacy without my prescription.

and be patient centric, they are not only going to lose patients, but lose patient trust. When corporate business “policies” override the Hippocratic Oath to first, do no harm, and do not give their pharmacists the ability to take care of the patients, there is a problem. Why aren’t pharmacy corporations today creating corporate policies that empower their employee pharmacists to put the patients’ health care needs first?

When you stay at a Ritz Carlton hotel, the employees anticipate the customer’s needs. This company gives its employees the ability and the authority to meet the customer’s every The pharmacist was not focused need, every request. If you order a on the health and well-being of her cup of tea, you don’t just receive a patient. Instead, she quoted not one, cup of hot water and a tea bag. The but two, corporate “policies” which server steeps the tea for you and serves had more to do with her concern for it to you in a warmed cup. They keep pharmacy inventory than patient care. a customer profile of your requests, She just refused to fill my prescription. so the next time you stay at a Ritz She put on her “policy blinders” and Carlton, your favorites are waiting for was not willing to come up with a you. (I love to see the popcorn and solution. I left the pharmacy empty M&M’s when I enter my room!) handed, frustrated and with tears in my eyes. I could not believe what had From the moment you arrive at the just occurred. It was a very surreal front drive, Ritz Carlton employees experience for me and one that I do strive to create and maintain a not want to experience ever again. It relationship with you. Why? Because made me think how other patients they want you to stay at the Ritz must feel experiencing similar service Carlton, year after year, no matter and not having the knowledge or where you are in the world. resources to navigate through the system on their own to find a solution. People want to know you care. Until this point, I have never had a bad During these difficult economic times, experience at any pharmacy. So when isn’t it good business for pharmacies this happened, I was hurt, humiliated to adopt the “policy” that that the and, most importantly, without my patient’s health care needs come first? medication. Don’t pharmacies want their patients to be loyal to them? Don’t they want I was hesitant to write about their patients coming back to them for this experience, but finally decided all of their prescription needs? Don’t that I needed to tell this story. If they want to establish a relationship pharmacists do not change their with their patients so that it keeps “policies” and put the patient first them coming back again and again?

Mindy D. Smith, R.Ph. Chief Executive Officer

From a business perspective, I would like to think that if pharmacies adopted the Ritz Carlton service model that their customer loyalty would increase, they would have more business and their profit margins would go up! We took an oath to take care of people. And yes, it does demand more from us than bringing a bowl of popcorn and M&M to our patients. I am not advocating for you not to respect and follow corporate policy, but I am advocating for improving patient health, putting the patient first, being patient centric and not letting concerns for following “policy” come between you and patient care. I believe that if pharmacists make the needs of the patient their number one priority, the rest will work itself out. Please consider this the next time you quote store “policy” that may be “good” for business, but horrible for patient care.

Arizona Journal of Pharmacy 3

New Members WELCOME NEW MEMBERS Khaja Basheer Ahmed Sara Badaglialacqua Don Baron Lori Bengel Elizabeth Braig Jamie Buchanan Laura Buckley Dawn Coslett Jesse Jay Cranmer Chris Ellis Tony Felix Stephanie P. Gillund Rebecca A. Grimm Mahdi Hammoud Anne Haney

Volunteer Recognition The Arizona Pharmacy Alliance

staff is here to support YOU - our members. We acknowledge the contributions of the volunteers who have recently made a difference for our organization and their fellow pharmacy professionals. Thank you for all you do! Jean Patel Heidi Mahay Bill Jones Bob Lipsy Lucas Nyabero Kimanga Lindsay Davis Carl Labbe Jon Glover Kim Kelley Julie Hernandez Leslie Rodriguez Jon Merchen Chris Tankersley Ken Mahan Steve Lemahieu Lindsay Huxtable Martha Fankhauser Kip Raney 4 Arizona Journal of Pharmacy

Karin Hansen Kimberly Harder-Ibarola Katherine Hinkle Anca O. Incean Sameer Fathalla Jazrawi Olusola Jolaogun David Konieczka Charlotte LaGreca Laura Latimer James Peter Lesniak Jeffrey Liberman Andy Lin Marilyn Luk Vani Malladi Herbert Phil Meshel Alan Barreuther Chris Lesaca Mike Taday Carol Rollins Jenna Carlson Ray Clark Kristen Allison Linda McCoy Mindy Burnworth Kristina De Los Santos Eric Weber Rick Herrier Mark Boesen Linda Baker Teresa Stickler Ken Fletcher Winnie Thi Ashli Rasmussen Amanda Carter Geoffrey Pesanka Whitney Shields Jim Kloster Terri Warholak Justin Brock Mark Boesen Kim Cauthon Mahendra Patel Elizabeth Louton

Michael Milinovich Salmah Monsour Barry Stuart Norman Jai Patel Suzanne Plano Marla Say Caroline Sepp Rodney Stirling Saji Thomas Renee Tyree John Vo Courtney Weiser Gary Wentworth Karen Yee Michael Zucarelli

MISSION STATEMENT The Arizona Pharmacy Alliance 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

Alliance News Do you know someone who is not a member of the Arizona Pharmacy Alliance . . . and should be?! Invite them to join the only statewide organization that represents the pharmacy profession in Arizona.

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Husband and wife pharmacists Persons who are not licensed pharmacists and are interested in pharmacy or are associated with businesses or professions related to the pharmaceutical profession 50% reduction for Pharmacists who are within one year after graduation from a college or school of pharmacy 25% reduction for Pharmacists who are within two years after graduation from a college or school of pharmacy

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Signature IMPORTANT INFORMATION REGARDING YOUR MEMBERSHIP DUES, TAXES AND DONATION TO THE APF. Of the "Membership Dues" payment, the amount listed below is deductible as a charitable contribution made to the Arizona Pharmacy Foundation (APF), a 501 (c) 3 non-profit corporation, Tax ID #86-0679270. The remaining portion is not deductible as a charitable gift, but may be deductible as a normal business expense. Membership payments to associations that are used for lobbying expenses are no longer deductible for federal income tax purposes. Of the membership dues payment to AzPA, 15% is non-deductible. Please consult your tax advisor on how these rules may apply to you. PHARMACIST Individual NEW PRACTITIONER 1st Year ASSOCIATE

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Arizona Journal of Pharmacy 5

Alliance News APF News

The Arizona Pharmacy Foundation (APF) welcomes Terry Daane, R.Ph., to the APF Board of Directors. Terry is a Pharmacy Supervisor with Fry’s Food and Drug. A past president of the Arizona Pharmacy Alliance, Terry is a long-time supporter of APF and its activities. He is a valuable addition to the APF board. APF is exploring the creation of a Prescription Medication Patient Services Program. This program would provide funding and/or support for patients who need prescription medications. In the developmental stages, an ad hoc committee will develop a proposal for funding, promotion, sustainability and grant submission guidelines for this program. Stay tuned! The APF is a non-profit, charitable foundation and 501 (c) 3 corporation. The mission of the foundation is to: • Promote and educate the public concerning the delivery of pharmaceutical care • Support research and provide scholarship programs to deserving pharmacy students • Provide leadership development training to pharmacists and students • Create educational programming for pharmacists • Provide public and professional services to advance education, research and the delivery of pharmaceutical care Fundraising activities for the foundation include the upcoming APF “Law on the Links” Golf Tournament. This year’s tournament will be held Friday, July 16, 2010 on the Arizona Biltmore golf course. The 18-hole scramble features case law scenarios with questions and citations at each hole from pharmacy statutes and regulations. The answers to the case law questions will be reviewed during a post-tournament luncheon. Upon completion of the tournament and CE review, participants will receive 1.5 law contact hours of continuing pharmacy education. A portion of the funds from the 2010 APF Golf Tournament benefit the Llyn Lloyd Service to Pharmacy Scholarship Fund. You can support the APF by becoming a tournament sponsor. Or better yet, put together a foursome and hit the links with us. Cost is just $125.00 per golfer. Sponsorship and golfer registration information are on available at www.azpharmacy.org

6 Arizona Journal of Pharmacy

PNA NEWS Bringing Asheville to Arizona

by Kathy Lin, University of Arizona College of Pharmacy Pharm.D. Candidate, Class of 2010 In January 2008, the Pharmacy Network of Arizona (PNA), a for-profit subsidiary of the Arizona Pharmacy Alliance, helped launched the first Arizona employer-based Patient Self-Management Program (PSMP) in collaboration with the American Pharmacists Association Foundation HealthMapRxTM Program and the Arizona Local Government Employee Benefit Trust (AZLGEBT). The HealthMapRx Program, modeled after the Asheville Project of North Carolina, is a partnership between pharmacists, diabetic employees and their health care team. In this program model, employers agree to incentivize their diabetic employees to participate in the program by waiving their medication and diabetic testing supply copays. Pharmacists, who are contracted with PNA, coach the enrolled diabetic employees on how to manage their blood sugar, blood pressure, and cholesterol during a face-to-face visit, usually at the site of employment. The employer pays the pharmacist a to be the self-management coach. The goal of the program is to improve the health and well-being of employees with chronic health conditions, which in turn can reduce health care costs and improve work productivity. Statistics from the Asheville Project, which has been ongoing since 1996, have shown a 50% reduction in employee sick days and an average net savings of $1,600 to $3,200 per patient annually. As a result of the project, the total savings on health care costs exceeded $5,000,000. When the HealthMapRxTM Program was first established in Arizona, it began with three pharmacists providing for servicescounty employees in three counties. Today, five pharmacists serve the following counties and cities: Graham County, Greenlee County, Gila County, Apache County, Parker, Lake Havasu City, and Nogales. There are 80 participants enrolled in the program. PNA coordinators Rose Martin, Pharm.D. and Nicole Scovis, Pharm.D. match enrollees to their pharmacists. “Currently, we to actively work with the employer group to expand

The innovative Asheville Project was started by a small group of pharmacists in the city of Asheville, NC. The project’s success has garnered attention in pharmacy practice and has been replicated by cities across the nation.

Alliance News Bringing Asheville to Arizona (continued from page 6) this program to other employer groups and other counties. We are looking forward to providing this type of disease management and medication therapy management services to patients throughout Arizona,” Dr. Martin said. Perspectives of Pharmacists and Participants The five pharmacists who are part of the PNA are Robert Montierth, Rhonda Eustice, Laura Adams, Jim Schleigher, and Rick Connors. Robert Montierth, Pharm.D., has been a diabetic consultant with PNA for two years. He serves employees and their dependents in Graham and Greenlee counties. While working in a rural community pharmacy, Dr. Montierth was inspired to be a part of the program when he noticed a gap in the way diabetic patients were being managed. “When I was approached with the idea of participating in a program that helped bridge that gap, I became very interested. Pharmacists can be a great asset to a diabetic, and I have seen that many times over.” Dr. Montierth meets with 33 patients for 20 to 60 minutes every other month in Safford and Clifton. A big challenge he overcomes with some patients is finding ways to motivate them and to keep them motivated to maintain long-term control of their diabetes. “It takes some creativity on almost an individual basis to meet their specific needs and situation,” he noted. With regard to the benefits of receiving pharmacist-directed MTMS, Martha Roybal, one of the participants from Clifton, commented, “Participation in the [program] has been a great help to me. I have learned to manage my disease of diabetes better. My blood work readings have been good. I’m on many prescriptions, so being a participant has really helped me.” Pharmacists in PNA can experience a sense of fulfillment knowing that their one-on-one meetings with the participants can positively impact their health. “The thing I like most about this program is the opportunity it provides me to sit down with diabetics and discuss everything or anything relating to diabetes that no one has ever spent the time to teach them, and then to have them improve their life because of that interaction,” Dr. Montierth pointed out. Rhonda Eustice, Pharm.D., CDE, has been with PNA since the program’s inception. Two days out of the month she serves 14 patients enrolled in Gila and Apache counties, rotating between sites in Payson and St. Johns. Dr. Eustice has worked in ambulatory care in the past and was inspired to expand the role of clinical pharmacists in the community. As a certified diabetes educator, she has dedicated her time to help certify other pharmacists in the state to provide this service. “I love that I have been able to help patients gain control of their diabetes when their physicians either didn’t have the time to devote to make the appropriate medication adjustments or didn’t know how to appropriately adjust their patients’ diabetes medications to achieve better control,” Dr. Eustice commented. For some people, diabetes can be a difficult topic to discuss with family members. Gabriella Romero, a participant from St. Johns, has been through this situation. “Family members are not very understanding. They do not want to talk about being diabetic,” Romero said. After being referred to Dr. Eustice, Romero expressed her support for the services she has received. “It is nice for someone to ask how you are. Rhonda gives me

encouragement to keep trying. She does not blame me for being a diabetic. She is always kind and gives helpful advice on how to handle my diabetes. When I do not understand something, she explains clearly. I appreciate her help and input on my diabetes.” Participants of the program have found value in meeting with a pharmacist on a monthly basis to gain the knowledge and skill needed to manage and maintain their blood sugar levels. “Having the coaching from a diabetes educator has been very useful. The meetings help me to stay on track with my diabetes management program, and I have received lots of valuable advice and information from my coach,” commented J.C. from Payson. Numbers Speak: Effectiveness of Program The program in Arizona has been a huge success. “The program allows patients to have access to the medications and monitoring of outcomes to ensure that the medications are working. The employer understands the value of investing in prescription medications as front-line therapy, which results in decreased overall medical costs,” stated Mindy Smith, Chief Executive Officer of the Arizona Pharmacy Alliance HealthMapRxTM compiled a Year 1 report for Graham, Greenlee, and Gila counties. From a cost-savings perspective, the three counties have experienced a significant savings. The baseline average total plan cost was $13,521 per participant per year; by the end of Year 1 of the program, the cost decreased to $12,225. The average decrease in medical costs after one year was $2,975 per participant. The average participant cost at baseline was $1,710 per participant per year; at Year 1, the cost was $1,428. When costs to the plan and participants were combined, the average total cost was $15,232 per participant per year at baseline and $13,653 at Year 1. Overall, the average savings per participant was $1,579. When actual cost was compared to projected cost for Year 1, the average savings per participant was $3,345. At baseline, the total health care cost was $517,873. At Year 1, the cost decreased to $464,203. When adjusted for inflation over one year, the total savings of the HealthMapRx Program amounted to $125,299. Both the health plans and participants have benefited from savings after enrollment with the program for one year. Compared to baseline, there were improvements in glucose control and cardiovascular health at the end of Year 1. Glucose control was assessed by changes in average hemoglobin A1c (HbA1c) levels. At baseline, the HbA1c was 7.83%; at the year’s end, it decreased to 7.13%, which was close to the target HbA1c of 7.0% proposed by the American Diabetes Association (ADA). Cardiovascular health was evaluated by blood pressure measurements and LDL cholesterol levels. The average baseline blood pressure was 134/95 (ADA goal: 130/80). By the year’s end, it decreased to an average of 126/75 with 40.7% of the participants achieving blood pressure in the normal/optimal category. The average baseline LDL cholesterol was 92 mg/ dL (ADA goal: <100 mg/dL) and at the year’s end, 90 mg/ dL. Although the difference was modest, 20% of participants achieved a value <70 mg/dL (optimal goal for high risk population) compared to 8.3% at baseline. Patient self-management was evaluated with a test of knowledge and skill. These assessments were administered at Arizona Journal of Pharmacy 7

Alliance News Bringing Asheville to Arizona (continued from page 7) the end of the year. From a sample of 34 participants, 67.7% were considered advanced or proficient in the knowledge assessment; 53% were considered advanced or proficient in the skills assessment. Overall patient satisfaction with the pharmacists was evaluated on a scale of 1 to 5, 5 being the highest level of satisfaction. Out of a sample of 28 responses, all respondents rated their satisfaction as a 5. Future of the PNA Where will PNA be in five years? Dr. Martin hopes that this pharmacy service will be expanded to other employers. “With this service, we hope to see that the pharmacists and providers of this program have effectively impacted the patient’s [diabetes] care and overall health, which consequently increases work productivity and decreases health care cost for both the employers and patients,” Dr. Martin said. Given the significant monetary savings, improvement in cardiovascular goals, and patient satisfaction attributed to the involvement of pharmacists in patient care, these findings reaffirm the value of expanding this program to all counties in Arizona. If more employers recognize the value of preventive care to employees, PNA can grow into a self-sustaining program. “This program has been a huge help to me. I have learned so much more than I even thought possible about foods’ impact on the blood sugar and how to eat and exercise to maintain good glucose levels. Basically, all the information on treatment of my diabetes has come to me through this program, and I would encourage any diabetic to take full advantage of this if it is offered to them,” said Janie Bennett from Payson.

Pharmacy Day at the State Capitol Pharmacy Day at the State Capitol 2010 (PDSC 2010) was held Wednesday, February 17, 2010, on the Senate Lawn of the Arizona State Capitol. Sponsored by the American Pharmacists Association (APhA) Academy of Student Pharmacists Chapters of Midwestern University College of Pharmacy – Glendale and the University of Arizona College of Pharmacy, and the Arizona Pharmacy Alliance, PDSC 2010 invited the Arizona legislators and their staffs to meet with pharmacy professionals and students, learn about the services pharmacists and pharmacies provide to our community, and discuss current issues relating to pharmacy and health care. Student pharmacists from both colleges of pharmacy participated, offering information and screenings on a wide variety of topics, including immunizations, medication therapy management, poison control, smoking cessation, diabetes, hypertension, asthma, and heartburn. Students and pharmacists took the opportunity to talk with their district senators and representatives and advocate for pharmacy. Several groups of students participated in tours through the Capitol, providing a behind-the-scenes look at the legislative process. Those in attendance had the opportunity to hear testimony presented to the house health committee on proposed legislation and witness a voter protest demonstration against a controversial bill. PDSC is a great way to become involved in the political process. Many thanks to Fry’s Food and Drug Stores for providing lunch for the event.

Interested in incorporating MTM services into your practice? For only $100, AzPA offers an MTM Toolkit, which has the tools you need for MTM interventions, comprehensive medication reviews, patient medication lists, and much more. The kit is available online at the following link: http://www.pswi.org/membership/ Toolkits.htm

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MWU-CPG student pharmacists conduct diabetes screenings, under the guidance of Dr. Erin Raney (right).

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8 Arizona Journal of Pharmacy

U of A COP student pharmacists raise awareness about breast cancer at PDSC 2010.

Alliance News - Addiction - Disease and Recovery - Preceptors’ Workshop • Exhibit Hall Cocktail Reception - Food, friends, fun and door prizes! • Midwestern University College of Pharmacy-Glendale Alumni & Friends Dessert Reception

The Arizona Pharmacy Alliance 6th Annual Meeting is coming!

Plan to attend Arizona’s largest annual pharmacy meeting! We will gather at the Arizona Biltmore Resort and Spa in Phoenix, Arizona for the AzPA 6th Annual Meeting. The four-day event begins Thursday, July 15, 2010, with an Anticoagulation Certificate Program (see page 10 for complete details) and will continue through Sunday, July 18, 2010, with more than 30 general pharmacy and drug therapy continuing pharmacy education programs. The theme of this year’s event if Changing Perceptions: Impacting Patient Health. Along the way we will celebrate our organization and its members with our mardi gras-themed Exhibit Hall events and the AzPA Awards Banquet. Jon Glover and Kim Kelley, Co-Chairs of this year’s Annual Meeting Steering Committee, and their committee members have put together a dynamic schedule of programs. Here are some highlights of what’s in store: Thursday, July, 15, 2010 (pre-meeting optional events): • Anticoagulation Certificate Program (separate registration required) • AzPA Board Meeting • VIP Reception (by invitation only) Friday, July 16, 2010 • Arizona Pharmacy Foundation Golf Tournament • and Law on the Links CE(separate registration required) • Pre-Symposium Pain Management Workshop (pre-registration required) • General Sessions: - Legislative Update 2010 – HIT - Immunization Update • Friday Breakout Sessions - New Guidelines for HTN - New Drug Update

Saturday, July 17, 2010 • AzPA Town Hall and Breakfast • Poster Exhibits • General Session: Health Care Reform and Medical Home • Saturday Breakout Sessions - Pychopharmacology in Adolescents - Pain Management from the Inpatient Perspective - Diabetes in Pediatrics and Adolescents - Medical Devices in Pharmacy Practice - Anticoagulation Update - Pain Management from the Outpatient Perspective: - Thromboembolic Disorders - Dermatology Update for Pharmacists - AzPA Journal Club - Residency Workshop - DM Therapeutics Debates in Disease Managment - Renal Workshop - HIV/AIDS Therapy - EBM & Drug Literature Evaluation - NASPA OTC Challenge 2010 • Exhibit Hall Luncheon - Food, friends, fun and more prizes! • University of Arizona College of Pharmacy Alumni & Friends Cocktail Reception • AzPA Awards Banquet Cocktail Reception • AzPA Awards Banquet and Entertainment Sunday, July 18, 2010 • Symposium: Combination Therapy in Psychiatry • General Sessions: - Panel Discussion: AWARE Rx - Raising Awareness of Teen Rx Abuse - Pharmacy Legislative and Regulatory Update 2010 • Sunday Breakout Sessions: - Urinary Tract Infections - HRT in Men - Advancing Pharmacy Practice Through Performance Measurement Clinical Pearls Registration is available online at www.azpharmacy.org or you may click here to download a printable registration brochure and form. See you at the Biltmore!

Arizona Journal of Pharmacy 9

Alliance News

Arizona Pharmacy Alliance and Arizona Anticoagulation Forum Anticoagulation Certificate Program

Thursday, July 15, 2010 GOALS: With expanded use of anticoagulant agents, the number of patients receiving these drugs has increased dramatically. Safe and effective anticoagulation must include a number of key components to avoid complications. These include careful patient assessment, an understanding of the clotting cascade and mechanisms of action of anticoagulant drugs, a detailed focus on factors which influence therapy and knowledge of current guidelines. This certificate program is a comprehensive program designed to provide pharmacists and nurses with the basic knowledge and skills necessary to care for patients taking anticoagulation therapies. By completing this course, pharmacists can earn 18 hours of continuing education credit while becoming certified in anticoagulation management. Join the growing number of pharmacists who are providing anticoagulation services. COURSE OUTLINE: PART 1 - DIDACTIC TRAINING: KNOWLEDGE-BASED LEARNING ACTIVITY (10 HOURS HOME-STUDY/ 1.0 CEUs) The didactic home study will consist of reading selected chapters from The Eighth ACCP Conference on Antithrombotic and Thrombolytic Therapy: Evidence-Based Guidelines Chest 2008;133(Suppl):67S-968S, completing study guide questions, and an open-book post-test with a score of at least 70% correct responses. Upon registration, the home study portion and references will be e-mailed to you, so you must provide a working e-mail address on your registration form (PERSONAL EMAIL ADDRESSES WORK BETTER DUE TO HIGH SPAM FILTERS ON EMPLOYER HOST ADDRESSES). There are seven separate sections (Heparin and Low-Molecular-Weight Heparin, Pharmacology and Management of Vitamin K Antagonists, Perioperative Management of Antithrombotic Therapy, Hemorrhagic Complications of Anticoagulant Treatment Antithrombotic Therapy for Venous Thromboembolic Disease, Antithrombotic Therapy in Atrial Fibrillation, and Antithrombotic Therapy in Valvular Heart Disease) each containing a required reading and study guide questions. Participants have two weeks to complete the required readings, study guide assignments, and open book post-test. The study guide questions and the post-test will be collected at the live CE program on July 15, 2010. Participants must receive 70% or higher score on the home study test in order to receive credit. The home study portion must be completed in order to participate in the live program. Pharmacists will receive CE credits of a total of 10 hours or 1.0 CEUs for the home study portion of this program. PART 2 â&#x20AC;&#x201C; LIVE PROGRAM TRAINING: PRACTICE-BASED LEARNING ACTIVITY (8 HOURS/0.8 CEUs) The live program involves 8 hours (0.80 CEUs) of both lecture and hands-on training. Participants will focus on the pathophysiology of thrombosis, receive an overview of ACCP Guidelines, discuss indications for anticoagulation therapy, warfarin dosing and monitoring, management of the over-anticoagulated patient and patients requiring procedure management, patient education, patient assessment, and quality improvement initiatives in anticoagulation management. At the conclusion of the live program, an open-book final exam must be completed with a score of at least 70% correct responses. Pharmacists will receive a total of 8 hours or 0.8 CEUs for completion of this component. Anticoagulation Certificate: In order to receive your certificate of completion, you must successfully complete both parts of the anticoagulation program. The steps need to be completed in succession as you will be unable to participate in the live program without first completing the home study program. Formal certificates will be mailed upon successful completion of the program in its entirety.

Pharmacists will receive a total of 18 hours of continuing pharmacy education credit (1.80 CEUs) upon completion of this seminar. DIDACTIC HOME-STUDY COMPONENT: ACPE #100-999-08-001-H01-P (10 hrs.or 1.0 CEUs) LIVE PROGRAM COMPONENT: ACPE #100-999-09-077-L01-P (8 hrs. or 0.8 CEUs)

SEPARATE REGISTRATION FEE REQUIRED. VISIT WWW.AZPHARMACY.ORG FOR DETAILS. PARTICIPANT REGISTRATION INFORMATION - A $50 late fee applies to registrations received after June 1, 2010. Before 6/1/10 After 6/1/10

AzPA Member Pharmacist Non-Member Pharmacist AzPA Member Student Non-Member Student AzPA Member Allied Pharmacy Professional Non-Member Allied Pharmacy Professional

10 Arizona Journal of Pharmacy

$300 $400 $200 $250 $200 $250

AzPA Member Pharmacist Non-Member Pharmacist AzPA Member Student Non-Member Student AzPA Member Allied Pharmacy Professional Non-Member Allied Pharmacy Professional

$350 $450 $250 $350 $250 $300

Alliance News

Member-Get-A-Member Challenge

Recruit a New Member for the Arizona Pharmacy Alliance and earn AzPA Buck$!

Open to all current members!!!

AzPA is the only statewide organization in Arizona representing all practice settings and is dedicated to empowering pharmacy professionals to provide optimal patient care. As the importance of patient care and medication management are underscored in the national debate, pharmacists are making an impact on the future of health care. The more members we have, the louder and more effective the voice of pharmacy becomes. That is why YOU are so important to us. If every current AzPA member recruits just ONE new member, imagine the potential to influence change for our patients and our profession. Here’s how you can help make the AzPA’s presence louder and stronger. If you know someone who is not an AzPA member - and should be - direct them to the AzPA website to join online. Or they may download a printable Membership Investment Statement and mail or fax it to AzPA. Have your New Member put your name in the “Referred by” section of their form. It’s that easy! For each new member you recruit, you will receive $25 in AzPA Buck$. Use your AzPA Buck$ toward continuing education programs, conference registration, annual membership - it’s your choice. And there is no limit to the number of AzPA Buck$ you can earn!

Challenge Rules: • • • •

Paid employees of AzPA are not eligible. Only one recruiter per new member. Renewal Memberships are not eligible. A “New” member is a person who has not been an AzPA member since 2005. • New members cannot recruit themselves; however after joining, they can enter into the contest by recruiting new members. • Recruiter must be a dues-current member of AzPA.

VOID We want you! The AzPA Membership Event is Wednesday, April 28, 2010, and we need enthusiastic, dedicated AzPA members to help increase our numbers. We will be working to recruit new members, recapture former members and retain current members. We need your energy and commitment - call the AzPA office today to join the team! Arizona Journal of Pharmacy 11

PAPA News Dangers of Ambien

Jim Corrington, Jr. MSW, LCSW PAPA Relapse Prevention Monitoring Program group leader and Calvary Addiction Recovery Center Ambien has been the subject of many discussions and

present as a very problematic drug in several recent cases in my world of addiction treatment, recovery and professional monitoring programs. Frequent stories of “sleep driving” or driving while in a blackout are becoming quite common. I’ve recently read a six-page police report of a DUI in which the only drug involved was Ambien. The driver was quite impaired and her behavior was bizarre, including her car hitting the officer’s car by accident. just walking away from the officer, and acting similarly to being in some trancelike state. This person has no memory of the entire incident. She simply took the Ambien “as prescribed” and ended up in jail. Other stories of “sleep eating” and “sleep phone calling” are also heard regularly. I’ve had a professional in recovery whose only drug of choice was Ambien. Scripts were being forged to obtain Ambien. I set out to question several local health professionals on what is their experience with Ambien, personally and professionally. Here are some of their responses: “It is a very dangerous drug.” “Strong caution is recommended when patients are on Ambien and opioids.” “Amnesia or blackouts are quite common, even when taken as prescribed.” “A person should be in bed when it is taken, otherwise odd things can happen.” “A physician or other health professionals prescribing should inquire about the details and history of the sleep problem in context with their entire profile, not just issue a prescription.” One personal example was relayed to me in which the person took the Ambien as prescribed, then proceeded to “take a week’s worth of all my other medications” while in an Ambien blackout. So, in general, Ambien is becoming a very problematic drug for many who are surfacing in the addiction treatment world. Addiction Medicine Physicians will generally steer people who are in recovery from addiction away from all sedative hypnotics, including Ambien. Total abstinence from all mood altering drugs is the goal and Addiction Medicine Physicians help their patients to find alternative ways to enjoy a healthy and normal sleep pattern. Arizona Addiction Medicine Physicians can be found at the following site: http://www.arizonasocietyofaddictionmedicine.com/

If you or someone you care about is suffering from an alcohol and/or chemical dependency problem…

“A Partnership in Caring”

Pharmacists Assisting Pharmacists of Arizona (PAPA)

is Available For Help and Information CALL LISA YATES AT 928-532-2293 ALL CALLS CONFIDENTIAL • CALLER REMAINS ANONYMOUS

AzPA Calendar of Events April 10, 2010 PTCB Exam Review Course Begins April 17, 2010 AzPA Health-System Academy Conference April 18 - 22, 2010 CPNP Annual Meeting April 29, 2010 Regional Rally - Tucson May 26 - 28, 2010 ASCP Midyear Meeting June 2, 2010 Regional Rally - Flagstaff July 15 - 18, 2010 AzPA 6th Annual Meeting Visit www.azpharmacy.org for all upcoming events. Empowering pharmacy professionals to provide optimal patient care

12 Arizona Journal of Pharmacy

Legislative Update Embracing Change - Change for Pharmacy and Change for Patients

By Mindy D. Smith, R.Ph., AzPA CEO and designated lobbyist AzPA President Mark Boesen and I were on Capitol Hill in early March during the NACDS RxIMPACT Day on Capitol Hill and APhA Annual Meeting advocating on behalf of the profession of pharmacy. We were joined by Linda Baker, Director of Government Affairs for United Drugs and member of the AzPA Legislative Committee. Whether you wanted health care reform legislation to pass or not, it is important to ensure the sustainability of our profession. Messages conveyed to advisors of Senator McCain, Senator Kyl, Congressman Flake and Congressman Shadegg included a focus on the expansion of pharmacists patient care services, since health care reform language recognizes the importance of an expanded patient care role for pharmacists through the delivery of medication therapy management services and coordination of care with other health care providers. AzPA conveyed the message that we support the MTM grant program that will test innovative ways to delivery MTM services; provisions that allow for pharmacists to play a vital role as a part of transitional care activities, the management of chronic disease, integrated care models and accountable care organizations; and, language that will codify changes made by CMS to the Medicare Part D MTM program. We also emphasized the need to support pharmacy exemption from DMEPOS accreditation requirements, fixing the AMP reimbursement definition to ensure fair reimbursement for Medicaid prescriptions, and asked for support of continuing to allow billing for vaccines to remain under Medicare Part D. In addition, several students, led by Ken Fletcher and Winnie Thi from Midwestern University amd Aimee Gowler from the University of Arizona, put their feet to the pavement, and walking the halls of Congress. They were able to meet with legislative assistants from the five of our Arizona Congressional representatives: Ann Kirkpatrick, Raul Grijalva, Harry Mitchell,Trent Franks and John Shadegg. Back on the home front, AzPA continues to monitor and respond to the following bills before Arizona’s 49th legislative session. (See the bill tracking list on page 12.) AzPA has also been closely monitoring the budget cuts. We have been watching the impact to pharmacy related to the workforce, the University of Arizona Poison Control Center and patient care/access issues. On Tuesday, March 16, 2010, the Legislature officially adjourned the 7th Special Session, sine die, after successfully passing 14 of 15 budget measures (including two ballot referrals) aimed at resolving Arizona’s $2.6 billion budget deficit. The special session, which was called by Governor Jan Brewer on March 5, 2010, lasted approximately two weeks and generated enormous controversy as legislators grappled with making deep cuts and program terminations affecting hundreds of thousands of Arizonans. On Thursday, March 18, 2010, Governor Jan Brewer signed the 12 budget bills comprising the FY 2011 budget, enacting approximately $1.1 billion in spending cuts and program terminations. She cautioned, however, that an additional $862 million in cuts would be further enacted should voters deny the

temporary one-cent sales tax measure on the special election ballot May 18, 2010. Democrats stated that the budget Governor Brewer signed will be subject to multiple lawsuits that will ultimately prevent many of the proposed cuts from taking effect. One of the primary and biggest legal challenges expected to be filed revolves around AHCCCS, the state’s Medicaid program, which is on the receiving end of $385 million in cuts that will necessitate more than 300,000 people losing health care coverage under Prop. 204. More details on the FY 2011 budget can be found at azleg.state.az.us/jlbc.htm. It is absolutely imperative that we continue our strong efforts at home and on Capitol Hill to advocate for pharmacy, our patients and our profession. It is important that we convey these messages as we embrace the changes which occur and ensure improved patient care. We have some real challenges facing us in this state when the budget cuts become reality as well as some great opportunities to embrace for the future of pharmacy. We must continue to advocate for pharmacy and demonstrate our value to patient care.

MWU-CPG student pharmacists (l to r): Winnie Thi, Robert Ferguson, Amanda Carter, Geoffrey Pesanka, and Ken Fletcher in front of the Capitol.

U of A student pharmacists (front row, l to r): Aimee Gowler, Kristin Calabro, Kelsey Mishkin, Ashli Rasmussen, and Whitney Shields with Jim Kloster, R.Ph., CGP, APhA Political Action Commitee Region VIII Governor (back row). Arizona Journal of Pharmacy 13

Legislative Update AzPA Bill Tracking List

To view copies of bills, visit www.azleg.gov and type in the bill number in the upper right hand corner. H2468: S/E optometry scope of practice AzPA opposed – AzPA would support additional language which requires optometrists to immediately refer a patient to a primary care provider when diagnosed with herpes zoster.

H2499: PRESCRIPTIONS; ELECTRONIC SUBMISSION BY PATIENT AzPA neutral with floor amendment that will be offered.

H2687: SALVIA DIVINORUM; UNLAWFUL ACTS AzPA supports

Replaces three specific macrolides with the term macrolides. Allows optometrists to prescribe, dispense and administer antiviral medications for treatment of diseases of the eye and its adnexa. Requiring a referral to a physician after 72 hours if the condition does not improve. Prohibits optometrists from prescribing, dispensing and administering an oral antibiotic or an oral antiviral to a person under six years of age.

First sponsor: Rep. Goodale

Allows prescription-only drugs to be dispensed when the patient submits the written prescription by fax or email. Stipulates that the patient must present a written prescription order bearing the prescribing medical practitioner’s manual signature when picking up the prescription at the pharmacy.

Hearing: 3/15 First Senate referred to Senate sponsor: hel-med. Rep. Murphy Healthcare & Medical Liability Reform (Wednesday 03/24/10 at 9:00 AM, Senate Rm. 1)

Creates a Class 2 misdemeanor for the act First sponsor: of selling, dispensing, distributing, Rep. Meyer furnishing, administering or giving or offering to sell, dispense, distribute, furnish, administer or give salvia to a person who is under 21 years old. Provides an affirmative defense to prosecution if the person reasonably relied on fraudulent proof of age presented by the person who is under 21 years old.

3/19 Passed House COW.

3/9 From House Rules ok.

S1144: DRUG OFFENSES; DEFINITIONS

Adds certain medications to the definition of dangerous drug offenses. Expands the AzPA monitoring this bill to ensure definition of a vapor-releasing substance containing a toxic substance to include a amendment in House will likely address discuss concerns of including non-narcotic fuel source or propellant that contains controlled substances. certain specified substances.

First sponsor: Sen. Huppenthal

S1216: ORAL ANTICANCER MEDICATION; Requires health insurers that provide coverage for both cancer chemotherapy COVERAGE treatment and orally administered anticancer medication to provide the AzPA neutral. Testified in committee to ensure involvement process for access to coverage without imposing additional cost patient care. sharing requirements for the use of orally administered medication than those for chemotherapy administered intravenously or via injection.

First sponsor: Sen. Leff

3/17 withdrawn from Senate appro.

S1258: MEDICAL RECORDS; DISCLOSURE; RELEASE

First sponsor: Sen. Leff

3/9 from Senate rules okay.

First sponsor: Sen. Verschoor

3/8 passed Senate 24-4; ready for House.

AzPA supportive in partnership with stakeholders of the Arizona Health-e Connection.

Permits the authorized disclosure of medical records or information, including clinical laboratory test results, to specified individuals or entities. Allows persons or entities that provide services to a health care provider or laboratory to receive medical records or information if the person or entity maintains a business associate agreement to protect the confidentiality of the information.

Hearing: 3/15 House Judiciary referred to House (Thursday jud. 03/25/10 at 9:00 AM, House Rm. 4)

An amendment was adopted to allow a person to opt-out of having their records released. There are discussions of making the bill an “opt-in,” which is not supported by proponents. S1285: OPTOMETRISTS; MEDICATIONS AzPA opposed – AzPA would support additional language which requires optometrists to immediately refer a patient to a primary care provider when diagnosed with herpes zoster.

Replaces three specific macrolides with the term macrolides. Allows optometrists to prescribe, dispense and administer antiviral medications for treatment of diseases of the eye and its adnexa. Requiring a referral to a physician after 72 hours if the condition does not improve. Prohibits optometrists from prescribing, dispensing and administering an oral antibiotic or an oral antiviral to a person under six years of age.

14 Arizona Journal of Pharmacy

Academy News Community Pharmacy Academy News Greetings once again from the Community Pharmacy Academy! Over our recent history the Community Pharmacy Academy has worked very hard to provide extra opportunities for our pharmacists and our profession to grow. Most recently, and most successfully, this occurred with the passing of new immunization legislation which has allowed certified pharmacists to provide immunizations to adult patients without a written physician prescription. With all of the worry and all of the media attention about this year’s flu season, it is obvious that allowing pharmacists to administer vaccinations has certainly helped to minimize the spread of disease. I can’t thank enough those involved with helping to get the legislation passed. Also, monumental thanks to those pharmacists that have jumped on board and provided immunizations to their patients. The impact on the health of the public has been noticed and the pharmacy profession is growing by leaps and bounds because of your hard work. I encourage those of you that haven’t yet done so to become certified

Kenneth R. Baker, RPh, JD Legal and Consulting Practice

Pharmacy Law Pharmacy Regulation Risk Management Insurance Pharmacy Quality Programs (CQI) Medication Error Reduction

immunizers and continue this positive impact to our communities. Now that the immunization bill is behind us, we find ourselves in the AzPA Community Academy asking “What Now?” Here are a few of the things that we currently have in our agenda: • Medication disposal—being environmentally and patient friendly • Promoting our services during Pharmacist’s Month • Expanding MTM services • Expanding the immunization bill (i.e. student pharmacists to administer?) • Organize more CE opportunities (MTM, immunizations, diabetic care, etc.) • Transfer promotions—right for pharmacy? Now is the time for us to continue to build on our momentum of professional growth and satisfaction. It is time to use your membership to its fullest - get involved and help us continue to provide opportunities to our pharmacists. Let’s keep the profession strong! If you have colleagues that aren’t members, NOW is the time to encourage them to join (technicians, too!). If anyone has any questions or would like to get more involved, please feel free to contact me at chad.schuster@frysfood.com. Again, thank you all for your continued membership and thanks for helping promote the profession of pharmacy in the community setting! Sincerely, Chad Schuster, Pharm.D. Community Pharmacy Academy Chair chad.schuster@frysfood.com

Phelps Dodge Tower One North Central, Suite 900 Phoenix, AZ 85004 602-307-9900 Main 602-256-3086 Direct 602-307-5853 Fax kbaker@rcdmlaw.com

Arizona Journal of Pharmacy 15

Academy News Health-System Academy News The 2010 Health-System Academy conference is Saturday, April 17, 2010, at Banner Desert Medical Center in Mesa, Arizona. The conference theme is Focus on Neurology: Advancement in Therapeutic Outcomes. This conference provides a total of 6.5 hours of CPE credit (0.65 CEUs), including 1.5 hours of Law CE. Sessions include Acute Stroke Management Strategies: Optimal tPA Timing and FV11a Use; Parkinson Disease: Pharmacotherapy Clinical Controversies; Alzheimerâ&#x20AC;&#x2122;s Disease: Clinical Trials; Pediatric Seizures 101: Clinical Pearls for the Non-Pediatric Pharmacist; Unique Infections: Parasites and Fungi; and Health Care Reform: Implications for Health-System Pharmacists. Registration is available online at http://fs7.formsite. com/AzPA/HSAConference/index.html The AzPA Health-System Academy is an affiliate of the American Society of Health-System Pharmacists. Mindy Throm Burnworth, Pharm.D., BCPS, has been elected as a 2010-2012 Arizona Delegate to the ASHP House of Delegates (HOD). Dr. Burnworth is an Associate Professor of Pharmacy Practice at Midwestern University College of Pharmacy Glendale. In addition, she is responsible for provision of clinical pharmacy services and maintenance of a clinical faculty practice site at a communitybased hospital and indigent care, teaching facility, respectively at the Maricopa Integrated Health System in Phoenix. Please congratulate Dr. Burnworth on her election to the ASHP HOD. Arizona has three delegates to the ASHP HOD. In addition to Dr. Burnworth, Kristina De Los Santos, Pharm.D., BCPS, and Eric Weber, Pharm.D., BCPS represent the Arizona delegation. If you have advocacy or legislative questions for ASHP, please email the delegates directly: Kristina De Los Santos kristina.delossantos@va.gov Eric Weber eric.weber@va.gov Mindy Throm Burnworth mburnw@midwestern.edu

16 Arizona Journal of Pharmacy

Arizona is very well-represented at ASHP. Kristina De Los Santos is a member of the Commission on Credentialing and Dianna Borowski has been appointed to the Council on Education and Workforce Development. Congratulations, Kristina and Dianna! Thank you all for your commitment to advancing health-system pharmacy practice in Arizona and beyond! Mike Dietrich, Pharm.D., BCPS Health-System Academy Chair 2009-2010 mdietr@midwestern.edu

2010 Arizona Pharmacy Alliance Health-System Academy Conference Focus on Neurology: Advancements in Therapeutic Outcomes Saturday, April 17, 2010 8:00 am to 5:15 pm Banner Desert Medical Center 1400 S. Dobson Road Mesa, Arizona 85202

6.5 hours of CPE credit (0.65 CEUs), including 1.5 hours Law CE. AzPA Member Pharmacist Non-Member Pharmacist AzPA Member Allied Pharmacy* Non-Member Allied Pharmacy*

$50 $80 $25 $40

Registration is available ONLINE ONLY at http://fs7.formsite.com/AzPA/HSAConference/ index.html *Allied Pharmacy category includes resident, student, pharmacy technician, nurse, industry representative and other nonpharmacist registrants.

Academy News Managed Care Academy News The 2010 AzPA Managed Care Academy Conference was held Saturday, March 27, 2010, at the Crowne Plaza Phoenix Airport Hotel. More than 60 participants attended this event. The conference provided 3.5 hours of ACPE accredited continuing pharmacy education, including 1.5 hours of Law CE. The two programs offered at this conference were: Focus on Biologics: The Who, When, and Why of Novel Approaches to IMID presented by Paul Yamauchi, M.D., Ph.D., with the Dermatology Institute of Santa Monica and Robert Lipsy, Pharm.D., FASHP, BCPS, from the University of Arizona College of Pharmacy and Law Update: Federal Legislative and Regulatory Issues for Managed Care Pharmacists presented by Marissa Schlaifer, M.S., R.Ph. from AMCP. Both programs were provided through generous support from the Academy of Managed Care Pharmacy (AMCP). Ray Clark, Managed Care Academy Chair-elect, Ken Mahan, AzPA Treasurer, and I were honored to join other leadership from AzPA at the AMCP Board and Leadership Winter Meeting on February 11, 2010, in Scottsdale. This was a tremendous opportunity to talk with pharmacy professionals in the managed care field about the issues impacting our practices. As health care reform continues with rigorous debate, in addition to a strained economy, members have been stretched hard in their current work and life environments. We are still looking for volunteers to get involved with AzPA in a number of key academy and committee positions. Visit the Managed Care Academy page of the AzPA website for more information. I look forward to seeing everyone at the AzPA 6th Annual Meeting! Sincerely, Kim Kelley, Pharm.D. Chair, Managed Care Academy kkelley@azblue.com

Lily Lee, Peggy Khan and Kim Kelley discuss the impact of the recent health care reform legislation during the Managed Care Academy Conference.

Bob Lipsy answers Suzanne Planoâ&#x20AC;&#x2122;s questions following his presentation at the Managed Care Academy conference

AzPA is looking for a few good educators! The demand for Carl Labbeâ&#x20AC;&#x2122;s PTCB exam review course offered through the Arizona Pharmacy Alliance has been steadily increasing as the need for certified technicians in many practice settings climbs rapidly. This successful program is looking for motivated educators as we expand to offer parallel sessions at the Alliance office as well at locations in Tucson and Flagstaff or Prescott. The course runs for seven consecutive weekly 3-hour sessions and covers calculations, pharmacy operations, terminology, pharmacology and disease states, aseptic technique, federal regulations, ethics, and pharmaceutical care principles. A benchmark exam is given near the end of the course. A focused evaluation is provided to the students based on the results of this exam. Interested pharmacists and technicians will be evaluated based on resume and performance on the benchmark exam. The course is modular in nature and multiple instructors may be needed to provide one complete course. Class times have been Wednesdays, 6PM to 9PM or Saturdays, 9AM to noon, but can be adjusted as necessary. This is a compensated activity, not a volunteer opportunity. If you are interested in becoming an instructor for the PTCB Exam Review Course, send your resume and cover letter to: Arizona Pharmacy Alliance, 1845 E. Southern Ave, Tempe, AZ 85282 or email mindy@azpharmacy.org. Arizona Journal of Pharmacy 17

Academy News Senior Care Academy News Dear SCA Members, COMING TO YOUR CITY: The American Society of Consultant Pharmacists (ASCP) Midyear meeting is here in Phoenix, May 25-28, 2010, at the J W Marriott Desert Ridge. Friday, May 28 is Arizona Pharmacists Day! ASCP invites all Arizona pharmacists to join us at our 2010 Midyear Conference and Exhibition in Phoenix. Expertise in managing drug therapy for older persons is becoming an increasingly important part of every pharmacist’s practice. Come discover what SENIOR CARE PHARMACY is all about. Take advantage of a special one-day registration fee of $50 - a $295 value - on Friday, May 28, 2010. Here’s what’s in store for you that day: • A full day of continuing pharmacy education on a variety of timely clinical, business, and policyrelated topics to strengthen your skills and improve patient care • Information about the abundant opportunities to expand your pharmacy practice to meet the growing market of serving seniors • Face-to-face interaction with companies offering products, equipment, and services that can help your pharmacy practice thrive • In-depth knowledge about new pharmaceutical products and disease management programs • Networking with hundreds of pharmacists who specialize in geriatric pharmacotherapy • For early bird registration savings register by March 26, 2010 at http://www.ascpmidyear.com/registration Pharmacists from all practice settings are welcome! In the previous issue of the Arizona Journal of Pharmacy, I asked you to please support the ASCP

18 Arizona Journal of Pharmacy

Foundation and lead ARIZONA to victory in the State Competition! The ASCP Foundation marked the 40th anniversary of ASCP with a contest. The state with the highest percentage of members contributing $40 or more to the Foundation between November 15 and December 18, 2009 won a prize. Unfortunately, Arizona did not win. The ASCP Foundation, like AzPA, is working for you to get the message out about the value of your services in ensuring appropriate, effective, and safe medication use in older adults. The donations went directly to support Traineeships, Practice Innovation recognition, Entrepreneur Grants and collaborative initiatives which provide the programs, resources and tools you need to optimize medication therapy and improve health outcomes - and the recognition you deserve as the expert in medication therapy management in older adults. Didn’t donate to support the ASCP Foundation this winter? You still have a chance to support ASCP. Gather your friends and colleagues, and join us on May 25, 2010, at the Wildfire Golf Club for a fun day of golf to support the ASCP Foundation 2010 Tim Webster Classic! This annual tournament is in memory of Tim Webster, ASCP’s former Executive Director. The format is a four-person modified scramble and awards will be given for the straightest drive, longest drive, closest to the pin, Hole in One (wins $1,000), and more. Individuals and teams are welcome! For more information go to http://www.2010twclassic.golfreg.com/ Hope to see you at the ASCP meeting! Dawn S. Knudsen-Gerber, Pharm.D., CGP Senior Care Academy Chair dknuds@midwestern.edu

Academy News

Technician Academy News Greetings, Technician Academy Members! In a recent press release from the Pharmacy Technician Certification Board (PTCB), the number of pharmacy technicians in the workforce is expected to increase by 32% by 2016. In today’s climate of high unemployment, certified pharmacy technicians are consistently included on the list of jobs available. As the demand for pharmacy technicians continues to grow, certification is expected to play an increasingly more important role in assuring the public of safe, accurate and efficient patient care and service. The Arizona Pharmacy Alliance offers a sevenweek PTCB Exam Review Course to prepare for the pharmacy technician certification exam. The class is designed for those who are currently working as a pharmacy technician-in-training, but is open to anyone wanting to prepare for the PTCB exam. The AzPA course is currently taught three times per year by Carl Labbe, R.Ph.. We are hoping to expand the number of classes offered, but we need additional instructors.

Pharmacists and technicians interested in teaching this course, please contact AzPA. Potential instructors will be evaluated based on their resume and performance on the benchmark exam. AzPA also offers for purchase the Pharmacy Certified Technician Training Manual – 10th Edition. This comprehensive text includes a calculations section and a CD answer key. The cost is just $60 plus shipping for AzPA members, $75 for non-members. Visit the Technician Academy page of the AzPA website to print an order form. Professionally, Jenny Whitney, C.Ph.T. Technician Academy Chair

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Drug Information Questions Question: Can sildenafil be used in the treatment of Female Sexual Arousal Disorder (FSAD)?

Laura Hanson, Pharm.D. Candidate and Elizabeth Pogge, Pharm.D., BCPS, Assistant Professor, Midwestern University College of Pharmacy-Glendale

Answer:

Female sexual dysfunction (FSD) is a problem affecting a large proportion of American women. Female sexual response is complex and goes beyond just genital response to encompass psychological desire and emotional intimacy. The complexity of sexual response in women leads to difficulty in definition, classification and diagnosis of FSD.1 Understanding the causes and efficacy of potential treatments of FSD is made difficult by the lack of a standardized method of assessment of the disorder.1 Female sexual arousal disease (FSAD) is a large subclass of FSD affecting up to 26% of American women. FSAD is defined by the DSM-IV as a persistent or recurrent inability to attain or maintain adequate genital lubrication and genital swelling until completion of sexual activity.2 The American Foundation for Urologic Disease defines FSAD as the persistent or recurring inability to attain or maintain sufficient sexual excitement, causing personal distress, which may be expressed as a lack of subjective excitement.3 However, there is some argument that both subjective and physical sexual arousal disorders should be included in this classification.2 One proposed pharmacological treatment for FSAD is sildenafil, a medication approved for the treatment of erectile dysfunction in males.2 Sildenafil is not currently approved by the United States Food and Drug Administration for use in female sexual dysfunction.4 In males, penile erection requires the relaxation of smooth muscle in the corpus cavernosa of the penis to allow for blood flow into the area. This is mediated by the release of nitric oxide upon sexual stimulation, which activates the guanylate cyclase enzyme responsible for increased synthesis of cyclic guanosine monophosphate (cGMP) which in turn allows for the necessary muscle relaxation in the corpus cavernosa. Phosphodiesterase type 5 (PDE-5) is responsible for the breakdown of cGMP and sildenafil acts as a selective inhibitor of PDE-5 thereby improving and/or prolonging erection.4 The female clitoris contains two corpus cavernosa and becomes erect in the same manner as the male penis during sexual arousal. In vivo studies have shown that sildenafil inhibits PDE-5 in the clitoris.1 PDE-5 is also present in labial and vaginal smooth muscle, although in much smaller quantities as compared to penile erectile tissue.2 Given the role of PDE-5 in female genital smooth muscle, it seems logical that sildenafil may be effective in the treatment of genitally based FSAD.1 Several clinical trials assessing the effectiveness of sildenafil in FSAD have been carried out, the results of which will be discussed below. One study from 2003 conducted by Basson et al.5 analyzed the safety and efficacy of sildenafil in 34 postmenopausal women receiving estrogen replacement therapy for at least 6 months 20 Arizona Journal of Pharmacy

who experience FSAD. The design of the study was a crossover, double-blind, randomized controlled trial. The diagnosis of FSAD in the participants was first confirmed using semi-structured interviews and self report questionnaires. Next, the participants underwent vaginal photoplethysmography in order to assess vaginal pulse amplitude while being exposed to both neutral and erotic stimuli. In this crossover study patients received each treatment, either 50 mg of sildenafil or placebo, over two separate sessions. Patients were instructed to take the medication one hour prior to sexual stimulation. After each administration of either placebo or sildenafil, participants were shown an erotic film and given a vibrator for sexual self stimulation for a maximum of 30 minutes. Time to orgasm was noted along with subjective intensity of orgasm, awareness of genital sensations, rating of overall sexual arousal and affective reactions using a self- report questionnaire. Overall, effects of sildenafil were not statistically significant for any of the outcomes assessed (P>0.05). However, when participants were divided into subgroups with women who had no significant change in vaginal pulse amplitude in response to a change from neutral to erotic stimulus, it was found that treatment with sildenafil elicited statistically significantly shorter latency to orgasm, higher perception of genital arousal and higher levels of overall sexual satisfaction as compared to treatment with placebo (P<0.001). Flushing, headache and mild dizziness were the most commonly reported adverse effects related to sildenafil administration. Although this study did not show efficacy of sildenafil for all patients, it did find a correlation between sildenafil efficacy and low vaginal pulse amplitude changes upon exposure to erotic stimulus. Another 2003 randomized, double-blinded, placebo-controlled study by Berman et al. 3 looked at the efficacy of sildenafil in 202 postmenopausal women with FSAD. The study design consisted of a 4 week treatment free period to assess baseline sexual functioning followed by a 12 week treatment period in which participants were given either 50 mg sildenafil (adjustable to 25 or 100 mg based on response) or placebo to be taken one hour prior to sexual activity. The primary outcomes were the results of two questions from the Female Intervention Efficacy Index addressing increased genital sensation during intercourse or stimulation and increased satisfaction with intercourse and/ or foreplay. Significant improvements were seen in the answers to questions 2 (P=0.017) and 4 (P=0.015) when comparing the sildenafil group to the placebo group. The participants were broken down into subgroups of patients with or without concomitant hypoactive sexual desire disorder (HSDD). Of note, this subgroup analysis showed that greater improvements were seen in women given sildenafil as compared to placebo in participants without concomitant HSDD (question 2, P=0.0004;

Drug Information Questions (continued from page 20) question 4, P=0.0001) while patients with HSDD did not show a significant improvement in the primary outcome (question 2, P=0.84; question 4, P=0.77). Adverse effects were mild to moderate in intensity and included headache, flushing, rhinitis, nausea and abnormal vision. This study shows that sildenafil has an advantage over placebo in the treatment of FSAD, especially in patients without concomitant HSDD. A 2006 double-blind placebo controlled study by Caruso et al.6 looked at the efficacy and safety of sildenafil in 32 premenopausal women with well-controlled Type 1 diabetes mellitus (mean A1C value 8.0% +/- 1.8%). Oral PDE-5 inhibitors have been found to be effective in males with Type 1 diabetes with sexual dysfunction but this was the first study done in women with this concomitant disease state. In this crossover study patients were assigned to 100 mg sildenafil or placebo to be taken one hour before sexual activity for 8 weeks, with a 7 day washout between treatment periods. Subjectively, efficacy was assessed using a self reported questionnaire rating arousal, desire, orgasm, enjoyment of sexual activities and frequency of sexual activity. Objectively, efficacy was assessed using the results of a clitoral Doppler ultrasound taken before and after each treatment period. Safety was evaluated via self reported adverse events. The results of the subjective efficacy evaluation showed statistically significant improvement in experience of arousal (P<0.01) and orgasm (P<0.05) with sildenafil compared to placebo and statistically significant improvement in experience of arousal, orgasm and enjoyment with sildenafil compared to baseline (P<0.001 in all areas). Pain during intercourse decreased during sildenafil treatment when compared to both baseline and placebo (P<0.05). The results of the evaluation of objective efficacy showed that clitoral blood flow was significantly improved in participants after sildenafil treatment (P<0.05). Adverse effects experienced by participants in the sildenafil treatment period included vision changes, headache and nausea. These effects were transient and mild. This study supports the use of sildenafil to treat FSAD in premenopausal women with Type 1 diabetes. Another study, published by Nurnberg et al. in 2009, looked at the use of sildenafil in the treatment of FSAD caused by antidepressant utilization. Participants in this study had no history of FSD but began to suffer from sexual dysfunction after beginning a serotonin reuptake inhibitor (SRI). PDE-5 inhibitors have been shown to be effective in the treatment of male sexual dysfunction secondary to SRI therapy but this is the first study analyzing PDE-5 inhibitor use for this purpose in females. This study was a double-blinded, prospective, parallel, placebo controlled, multi center trial spanning four years. In this study, 96 participants received either placebo or 50 to 100 mg sildenafil 1 to 2 hours prior to sexual activity for 8 weeks. The dose was determined by the investigator through assessment of efficacy and tolerability. Outcomes were primarily assessed using the Clinical Global Impression sexual functioning scale, a clinicianrated scale. A statistically significant difference from baseline to endpoint (mean endpoint difference of 0.8; P=0.001) was found in the sildenafil-treated group as compared to the placebo group. The most common adverse events reported at a higher rate with sildenafil as compared to placebo were headache, flushing, 7

dyspepsia, nasal congestion and visual disturbances. In conclusion, there is some evidence from double-blinded, randomized controlled trials supporting the use of sildenafil in FSAD. The evidence discussed indicates that this treatment may be especially useful in women with Type 1 diabetes and in those women whose sexual dysfunction is a consequence of SRI use. Evidence shows that postmenopausal women overall can benefit from sildenafil, especially those women who have reduced vaginal blood flow upon erotic stimulation. Side effects appear to be similar to those found in males and are generally mild and transient. Standardization of diagnostic and assessment tools among studies would be helpful to allow for more easily comparable data. FSAD is a complicated disorder with many contributing factors, but sildenafil may have a place in therapy along with psychosocial interventions. References: 1. Brown DA, Kyle JA, Ferrill MJ. Assessing the clinical efficacy of sildenafil for the treatment of female sexual dysfunction. Ann Pharmacother 2009;43:1275-85. 2. Schoen C, Bachmann G. Sildenafil citrate for female sexual arousal disorder: a future possibility? Nat Rev Urol 2009;6:216-22. 3. Berman JR, Berman LA, Toler SM, et al. Safety and efficacy of sildenafil citrate for the treatment of female sexual arousal disorder: a double blind, placebo controlled study. J Urol 2003;170:2333-8. 4. Sildenafil monograph. Drug facts and comparisons. Drug facts and comparisons 4.0 [online]. 2005. Available from Wolters Kluwer Health, Inc. Accessed 02 Dec 2009. 5. Basson R, Brotto LA. Sexual psychophysiology and effects of sildenafil citrate in oestrogenised women with acquired genital arousal disorder and impaired orgasm: a randomised controlled trial. BJOG 2003;110:1014-24. 6. Caruso S, Rugolo S, Agnello C, et al. Sildenafil improves sexual functioning in premenopausal women with type 1 diabetes who are affected by sexual arousal disorder: a double-blind, crossover, placebo-controlled pilot study. Fertil Steril 2006;85:1496-1501. 7. Nurnberg HG, Hensley PL, Heiman JR et al. Sildenafil treatment of women with antidepressant-associated sexual dysfunction: a randomized controlled trial. JAMA 2008;300:395-404.

CALL FOR NOMINATIONS A privilege of membership in AzPA is the ability to participate in the nomination and election of the board of directors. Board nominations are now being accepted via the link below. http://www.azpharmacy.org/2010_2011_BOD_ Nominations Your voice is important to the future of our profession and AzPA! Please consider running for a position on the 2010 - 2011 AzPA Board of Directors. HONOR YOUR PEERS AND COLLEAGUES! If you know someone who is worthy of receiving one or more of our annual awards, please submit your nominations at: http://www.azpharmacy.org/2010_Awards_ Nominations Arizona Journal of Pharmacy 21

Student Perspective Leadership: It’s About Passion!

by Pam Coumans, Pharm.D. Candidate, Midwestern University College of Pharmacy-Glendale, Class of 2010

With slim profit margins, the days of pharmacists being

paid for only filling prescriptions are fading quickly. Look at the numerous $4 plans throughout the country. What about our clinical knowledge? Can pharmacists’ knowledge be paid $4 at a time? As a profession, we need innovation. Designed to lead the profession through the paradigm shift, as one product life is on the decline, another must take over. There are numerous pharmacists currently practicing, but do they see the need for change? Not all of them, maybe not the majority of them, but hopefully the leaders of the pharmacy profession have a vision of the future. The future of pharmacy is at our fingertips. Close your eyes, find the vision, and pursue it. If a law prohibits our vision, we need to find ways to get the laws changed. It is not good enough for us to say, “Well it’s a good idea, but we aren’t allowed to do that.” A prime example of this is the legislation that was signed by Governor Brewer, allowing Arizona pharmacists to administer all but four adult immunizations without prescription. If you talk with the stakeholders who were involved in getting the legislation passed, they will tell you it was a long yet rewarding process. Introduced into the house January 20, 2009 and signed into law July 10, 2009 by the Governor, HB 2164 is changing the way pharmacists practice in Arizona. By the end of November 2009,

the Arizona State Board of Pharmacy reported 1,141 pharmacists had completed the necessary application process and are now immunization certified. Not every pharmacist will immunize, but it is important to expand the profession as we face the shift in pharmacy from product-centered to patient centric. The American Pharmacist Association (APhA) publishes numerous articles about pharmacists who are redefining the profession. They recognize “distinguished service on behalf of American pharmacy” yearly with the Remington Honor Medal. Past APhA Executive VP and CEO, John Gans was the recipient of the 2009 Remington Honor Medal. He has spent his career redefining the profession of pharmacy from the dispenser role to help physicians “better understand the benefits of collaborative team care.” We need to use our knowledge to drive the profession where we want it to go. The vision of every community pharmacy having clinical pharmacists with multiple MTM programs and collaborative practices is the future of pharmacy seen when I close my eyes. Now is the time to make that vision come to the present. Leaders can inspire, but it is up to the profession to take hold of the ideas and make them happen. Be a part of your profession. As John Gans demonstrated throughout his career, you do not have to be satisfied with “status quo.” We have an obligation to care for our patients. We have the knowledge to care for our patients. Do you have the vision? Do you have the passion? Let us change the profession to focus our careers on our patients.

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22 Arizona Journal of Pharmacy

Student Perspective Teaming Up for a Unique Experience

by Jessie Kim, Pharm.D. Candidate, Midwestern University College of Pharmacy-Glendale, Class of 2011 Given the complexity of providing quality healthcare, the importance of an interdisciplinary approach to healthcare is becoming much more apparent. When interdisciplinary teamwork is at its best, each team member is able to contribute their unique knowledge to accomplish the best patient outcome. Although this approach may seem like an easy task, it requires a change of behavior and mindset that students must put into practice early on in their professional training. In order to meet this need, pharmacy students at Midwestern University have the opportunity to hone their teamwork skills by engaging in a unique experience to be part of a healthcare team. Health Outreach through Medicine & Education (H.O.M.E.) is a health outreach project that has been providing medical care and health education to the homeless community of Arizona since 1999. While volunteering at one of its clinic locations at Central Arizona Shelter Services (CASS), a pharmacy student can expect to join a team of other medical, physician assistant, and podiatry students to see patients and contribute their unique knowledge to devise a diagnosis and treatment plan for each patient. Common acute care visits include patients with the common cold, infections, and skin eruptions. The team will thereafter present the patient’s case to the attending physician, physician assistant, podiatrist, and pharmacist at which point they will discuss the disease state and educate the students. This experience is unique to pharmacy students as they are rarely exposed to the initial medical presentation. In most

situations, pharmacists review a patient’s chart after the chief complaint interview, physical exam, diagnostic tests and diagnosis are already made. However, H.O.M.E. clinics offer a healthcare arena where pharmacy students can observe, learn, and perform all these tasks first hand. It is exciting to see how to correctly wrap a painful ankle, perform a leukocyte urine test, or hear how crackles sound through a stethoscope. Another benefit is the opportunity for preceptors and students to provide and share drug information with medical and podiatry students. In this way, the value of pharmacy is instilled in them early on in their professional career. The value of pharmacists and pharmacy students to H.O.M.E. outreach activities was illustrated in the study, “Description of Pharmacist Interventions in a Mobile Multidisciplinary Health Clinic for the Homeless”. The objectives of this study were to quantify and identify the types of pharmacy interventions that were made during health clinics at CASS over a six month period. By recording the types of interventions made by pharmacist preceptors, the authors established that most interventions involved medications for pain and infectious diseases. The benefit added by pharmacists was a total of 111 total interventions made with 122 patients, a testament to the significance of pharmacists in a multidisciplinary health care team. Some examples of pharmacist interventions were medication recommendations related to analgesics and antibiotics as well as disease state counseling related to smoking cessation, diabetes, and asthma. H.O.M.E. health clinics offer this multidisciplinary teaching and learning environment to preceptors and students alike. Health clinics occur at CASS every Tuesday from approximately 6:30 PM to 9:30 PM. To volunteer as a pharmacist preceptor for a CASS health clinic, please contact Kim Cauthon, Pharm.D., H.O.M.E. Pharmacy Advisor at kbyrdx@midwestern.edu or Jessie Kim, Pharm.D. Candidate, H.O.M.E. Pharmacy Coordinator at jessie.kim@azwebmail.midwestern.edu.

Midwestern University College of Pharmacy - Glendale faculty and students volunteer at Central Arizona Shelter Services (CASS). Arizona Journal of Pharmacy 23

Feature Pharmacist Practice Your Passion

by Pam Coumans, Pharm.D. Candidate, Midwestern University College of Pharmacy Glendale, Class of 2010

If you are Christine Aguilar, it’s not just about the practice of pharmacy it’s about the passion. Christine has done a great deal throughout her career. When I asked to interview Christine she was taken aback and thought, “Oh that’s nice, but why me? I haven’t done anything special.” Well by the end of this article, you will know the truth. Christine has done many things that make her unique. It is not just one degree, one job, or one certificate that demonstrates the passion Christine feels. It is a lifetime of learning and searching for the place she can make a difference. Christine started her career in pharmacy at the University of Illinois Hospital working in the administrative office. Performing quality assurance, drug utilizatin review (DUR), and audits as a student, Christine was fortunate to intern at a progressive hospital. Christine was hired at the University of Illinois Hospital upon graduation, where she became a staff pharmacist. The University had satellite pharmacies, where Christine and the other pharmacist rotated between the intensive care, neonatal, and transplant services as well as time in the central pharmacy. When she graduated in 1983, the University of Illinois had just converted to the Pharm.D. program. Christine opted to start her career with her Bachelor of Science in Pharmacy and work on her Pharm.D. while employed as a pharmacist. Have you heard of pharmacovigilance? Christine can tell you all about this. “Pharmacovigilance is really the drug company being vigilant and reporting adverse drug reactions (ADRs).” She spent four years in Abbott’s international division. Educating Abbott Italy, Abbott France, Abbott Germany and a host of international arms of Abbott. “From Abbott headquarters we serviced the Abbotts that are around the world,” Christine said. The “affiliates” of the international departments were usually physicians. Christine recalls fondly the ease of communicating with physicians, as they possessed the medical knowledge necessary to facilitate understanding. The international affiliates reported the ADE information to headquarters and they would in turn use this data to report adverse drug events (ADEs) to the Food and Drug Administration. Christine processed a quarterly report used by the company to determine if it was necessary to change labels or invoke another means to address the data and the necessary response from Abbott. At one point in her career at Abbott, Christine was called upon to start the company’s drug information department. “In those days, they didn’t have a drug information group at Abbott International. My clients were the internal Abbott affiliates. I’d be the one to go around Abbott to find the scientist that was working on the product, talk to various departments, and find information,” Christine explained. “Poland needs training on Hytrin,” was a fax that changed Christine’s responsibilities at Abbott significantly. As Christine in her nonchalant manner said, “Oh, I could do that,” she was quickly tasked with developing and presenting international medication training. Christine worked closely with a business partner who focused on the marketing as Christine focused on 24 Arizona Journal of Pharmacy

the clinical and medical aspects. She worked for a time on the business side of Abbott, moved to Arizona and became a sales representative of Prevacid for six years. Removed from direct patient care, Christine experienced medicine from a different perspective. Christine recalls thinking, “I miss pharmacy. I need to get back into being a pharmacist.” She started searching for a clinical position and found a good match in a clinical department with a pharmacy benefit manager (PBM). DUR, phone calls to discuss duplication of therapy, drug-drug interactions, ADR and compliance were all topics Christine would address in the doctor phone call department at the PBM. The repetition of having the same interaction pop up compelled Christine to look again for something “more clinical.” “At this time I didn’t know anything about medication therapy management (MTM),” Christine recalls. Christine’s search for something more clinical lead her to the University of Minnesota and their Pharmacy Practice Certification Program, drug therapy management. “In order to complete the certification I needed to do MTM on at least 50 people.” Christine worked on the program, completed the MTM’s, and presented case presentations to colleges via the internet. With a sigh of relief Christine says, “Drug therapy management, this is it. After 20 years I had finely found my passion.” With the completion of the program, Christine searched again for a position to use her skills. She found a position at a PBM and performs MTM over the phone. She recalls, “Before I [found] the Drug Therapy Management at the PBM, I was trying to find out were MTM was going on.” As an active member of AzPA, Christine has completed a number of the programs sponsored by the Alliance. She completed the APhA MTM Certification Program in 2007, and spoke with Mindy Smith about her passion for MTM. The AzPA had a MTM task force, and as a member of the task force Christine went through the same training that certified the Ashville Project pharmacists. In 2008 Christine completed her Diabetes Management Certification Program from the University of North Carolina Chapel Hill. Christine’s goal was to become one of the pharmacists performing MTM in the AzPA MTM initiative and travel to Payson or Safford The drive was prohibitive, but Christine did not loose her momentum or passion for MTM. She found another opportunity. In March 2009, Christine accepted a position at Mountain Park Health Center. She runs one of their Coumadin clinics. The health center received a grant from APhA’s Community Education Foundation and Christine started providing MTM along with the anticoagulation monitoring. There are three main outcomes the program is targeting: an increase in health literacy, an increase in adherence, and an increase in blood pressure control. Christine explains, “Lots of patients don’t even know what a refill is.” She motivates them to lose weight, educates them about diabetes, and “empowers the patient.” Christine is motivated. MTM is her passion. She has many certificates which equip her to provide patient care and pursue her passion. She is currently working toward becoming a Certified Geriatric Pharmacist (CGP) and wants to pursue a certificate in asthma education. Christine’s experiences reveal there are numerous opportunities to expand your practice, expand your education and find your passion.

Feature Pharmacist

Practice Your Passion (continued from page 22) Are you like Christine, looking for your passion? Are you willing to do what it takes to find your passion? Christine is amazing and her passion can ignite your passion. Christine puts into words her concerns regarding health care reform and MTM. “Make sure pharmacists are involved. We can show them, with MTM, what we can contribute to the state of health care.” Christine expresses concern that perhaps the pharmacist who has 23 years of experience may not be interested in MTM and instead the new graduates are the only pharmacists who desire to be involved with MTM. Well,you can clearly see from Christine’s career path, MTM is a decision for the professional of all graduating classes. As pharmacists, we are in a profession that requires dedication to a lifetime of learning. If we follow Christine’s lead and look for opportunities to expand our practice, we can “show them what we can contribute to health care.”

Pam Coumans interviews Christine Aguilar, Pharm.D.

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Psyched about Pharmacy

by Kathy Lin, Pharm.D. Candidate, University of Arizona College of Pharmacy, Class of 2010 I thought I might have been crazy when I signed up for two pharmacy rotations in neurology and psychiatry. I knew little to nothing about these fields. Twelve weeks later, I left with a new knowledge base and everlasting appreciation for neuropsychiatry. During my time at University Physicians Healthcare (UPH) Hospital, I was privileged to work under the direction of Martha (Martie) P. Fankhauser, M.S. Pharm., FASHP, BCPP. Ms. Fankhauser is a clinical professor in the Department of Pharmacy Practice and Science at the University of Arizona College of Pharmacy. She coordinates six-week rotations for pharmacy students and in 2009 alone 40 pharmacy students completed her rotation in neuropsychiatry. Martie has served as faculty advisor to 49 pharmacy students and teaches courses on introduction to mental health, chronic pain management, and clinical pharmacotherapy of mental disorders. From 1995 to 2004 she served as residency director for the ASHP-accredited Neuropsychiatric Specialty Practice Residency Program, which nine pharmacists have completed. In addition to academia, Martie is a consultant for UPH Hospital, COPE Behavioral Health Services, and La Frontera. In collaboration with the Tucson Police Department and the Pima County Sheriff Department, she offers her expertise on psychopharmacology in the Crisis Intervention Training Program. Ms. Fankhauser has received numerous awards for her service to patients and education. She was awarded the Clinical Pharmacy Educator Award by the University of Arizona College of Pharmacy in 1988, 1993, 1997, and 1999. In 2008, she was the recipient of the Arizona Pharmacy Alliance Exemplary Patient Care Award. Despite her heavy schedule, Martie was very gracious to set aside time for an interview. What sparked your interest in neuropsychiatry? A friend of mine was the pharmacy director at Mecklenburg Mental Health Center in Charlotte, NC, and he offered me a part-time job. This was the beginning of my career in psychiatry, and I helped to develop a medication education program at the hospital with a psychiatric nurse, Wanda Lancaster. [We] became involved statewide to promote medication education for patients and received a grant for developing a teaching program. What led you to pursue an academic position with the University of Arizona? I came to the University of Arizona to complete a M.S. in Pharmacy and a 1-year specialized residency program in psychiatry from 1980 to 1982. I decided that I needed further training in psychiatry and was fortunate that the University of Arizona received funding from Pima County for a specialized residency in psychiatry. When I finished, there was a faculty position available in the Department of Pharmacy Practice, so I joined the faculty in 1982. I was the first pharmacist in the state of Arizona that had completed a specialized residency program, Arizona Journal of Pharmacy 25

Feature Pharmacist Psyched about Pharmacy (continued from page ) and the College wanted to have faculty that would teach and mentor pharmacy students. Education is the mainstay of your profession. In what ways have you served as an educator to the people around you? Since I was a little girl, I have always wanted to be a teacher. I feel that teachers throughout my life made a major impact on me and my career. My jobs have always involved teaching or education, whether to other professionals, patients, or students. I feel I’ve been blessed to combine my love of pharmacy, psychiatric and neurologic practice, and education for the past 36 years. What is your response to the notion that neuropsychiatry is “too narrow of a field” for pharmacists to be involved in? “Neuropsychiatry” really combines both specialty practices and deals with the study of mental disorders attributable to diseases of the nervous system. Because individuals often have both types of disorders, I want to be able to help any patient who suffers from either psychiatric or neurologic disorders. Although this is a specialty area, the majority of medications prescribed for patients in the U.S. are agents that impact the central nervous system, and these agents can cause significant adverse effects and drug interactions. All pharmacists should understand the pharmacology of psychotropic medications and be able to assess medications for efficacy, drug interactions, and adverse effects.

Presently, what are the prospects of pharmacists finding a career in neurology or psychiatry? We have a national organization, the College of Psychiatric and Neurologic Pharmacists (CPNP), which is involved with the accreditation of specialty residency programs and also has a job listing service on their website: http://cpnp.org/. The individuals who work in psychiatry or neurology are very involved at all mental health institutions and the area is growing because these disorders are life-long and require both acute and maintenance therapies. What words of advice would you share with pharmacy students and pharmacists? Keeping up with the literature, both in reading and dissemination of information, is essential if you want to be a respected professional. Pharmacy is a life-long educational process that requires the dedication to always look up information, provide patient counseling, consult with other health professionals, and hold the highest standards for patient safety. Each year when I hear the new graduates take the “Oath of a Pharmacist”, I am very touched since these words are a reflection of why we are important in providing health care and why we need to be actively involved in improving patient outcomes.

Out of all the professions that exist, why pharmacy? My father, Willis Fankhauser, owned his store, Fankhauser’s Pharmacy, in Lyons, Kansas from 1946 to 1977. I feel that the early influence of my father and working at his store while growing up and during college was a major factor for my love of pharmacy practice. At the UPH Hospital, the psychiatrists constantly request your consultation services. How did you develop the trust and relationship with the psychiatrists? In psychiatry and neurology, pharmacists are often considered an important member of the health care team and are the specialist in drug information. Many of the consultations involve drug selection, dosing, starting/stopping medications, combination therapies, adverse effects, special populations (e.g. elderly and pregnancy), and comparison of drugs. Psychiatry is team-based with many different types of professionals working together for patient care activities. What achievements are you most proud of? Besides having my two wonderful children, I would say that my major achievement was choosing pharmacy for my career. For a later achievement in life, I feel that receiving the 2003 Judith Saklad Memorial Award by the College of Psychiatric and Neurologic Pharmacists was a highlight of my career.

26 Arizona Journal of Pharmacy

Martie Fankhauser in her office at UPH Kino. Photo courtesy of Clint Hinman, Pharm.D.

Feature Pharmacist Personalized Patient Care

by Eric McCarthy, Pharm.D. Candidate, Midwestern University College of Pharmacy Glendale, Class of 2010

Mickey Sussman, R.Ph., FACA is the president and owner of Scottsdale Professional Pharmacy, Ltd. This independently-operated store offers a wide range of customized medications and serves a variety of customer needs, including natural hormone replacement therapy, private label “skin-ceuticals” for plastic surgeons and medical estheticians, and veterinary medications. I had the tremendous opportunity to complete an IPPE rotation at this practice site. Over a four-week period, I learned how to compound medications into different dosage forms and experienced the rewards and challenges of owning and operating an independent pharmacy. Mickey has a Bachelor of Science in Pharmacy from Temple University, graduating in 1967. He is licensed to practice in Pennsylvania, Ohio, and Arizona. He is a member of the Arizona Pharmacy Alliance and the Professional Compounding Centers of America (PCCA). Mickey is also a fellow of the American College of Apothecaries. In 2009, the University of Arizona College of Pharmacy presented Mickey Sussman with a certificate to recognize his 25 years of service as a preceptor. A long-time member of the International Academy of Compounding Pharmacists (IACP), a non-profit association with a mission to protect, promote and advance the art and skill of the compounding pharmacy profession, in 2009 Mickey attended IACP’s annual Compounders on Capitol Hill meeting in Washington, D.C. This event provides compounding pharmacists and other stakeholders in the profession the opportunity to make the case for protecting compounding to their elected representatives in Congress. Mickey says, “The IACP meeting is a way to unify the compounding profession in front of the most important audience we'll face, the Senators and House members who will legislate our future.” How would you describe your practice setting? Scottsdale Professional Pharmacy was originally opened in 1963, making it the oldest pharmacy in the city of Scottsdale. I purchased the store in 1978 and we have been serving the community ever since. We specialize in compounding bioidentical hormone replacement therapy (BHRT) and “skin-ceuticals”. Scottsdale Professional Pharmacy is dedicated to providing personalized patientcare compounding services for optimal therapeutic outcomes.

Mickey Sussman, R.Ph., owner of Scottsdale Professional Pharmacy, Ltd.

What health care reform provisions are worth supporting? And opposing? I support the inclusion of a quality, strong MTM plan, raising the percentage on average wholesale price (AWP), and having PBM transparency. I oppose the provisions that may further privatize of our health care system. What patient services does your store provide that differ from a traditional retail pharmacy? Scottsdale Professional Pharmacy offers sales through instore service and delivery service. The dosage forms we are able to compound can meet the needs for specialized dosing due to age-related issues (pediatric or geriatric), including any change in physiological absorption, distribution, metabolism, and/or excretion of medications. What do you think independent pharmacies will be like 10 years from now? Pharmacy compounding has evolved into a specialty practice within the pharmacy community today. New applications to meet today’s patient needs require additional education, equipment and processes that not all pharmacies possess. Today, there are hundreds of licensed compounding pharmacies in this country that play a vital role in making sure patients get the medications they need that may not be available from pharmaceutical manufacturers. When I meet and work with bright, enthusiastic students like you, I know the future of pharmacy is in good hands. Arizona Journal of Pharmacy 27

Features and Articles The Partnership: Jeff Gray and AzPA

by Pam Coumans & Eric McCarthy, Pharm.D. Candidates, Midwestern University College of Pharmacy Glendale, Class of 2010 Do you appreciate a predictable schedule? Our lobbyist Jeff Gray from R & R Partners has anything but a predictable schedule. Jeff is dedicated to the Alliance. He spends an enormous amount of time on our behalf, making it possible for the members of AzPA to relax and know Jeff is at the Capitol watching out for our profession. During our rotation with AzPA, we had the opportunity to meet with Jeff for a personal tour around the State Capitol. The interview with Jeff planned at R & R’s office downtown took place instead on the fly at the Capitol. Although it was one week before Christmas, the Governor called another emergency session and legislators were back at the Capitol to address further budget cuts. As Jeff worked throughout the morning, we followed closely and observed our contracted lobbyist. Upon arrival and brief introductions, we rushed with Jeff to a press conference of the Democratic Minority Leaders. Caught up to speed with the mood at the Capitol, it was obvious this would be anything but a typical interview as Jeff texted throughout the press conference. The tension between the democrats and republicans continued throughout the day. In the lobby of the House of Representatives, Jeff spoke with colleagues from his lobbying firm until the bills arrived. Jeff scanned the documents looking for language that would affect pharmacy, mention of sweeps from the Board of Pharmacy, and cuts to the universities. Upon review of the documents, Jeff reported, “They’re not messing around with poison control centers, Board of Pharmacy….no sweeps of 90 -10 boards…. the University’s exempt as well.” A sigh of relief, but Jeff was not done with this bill yet. He rescanned the legal document looking for other hot spots that he oversees for R & R partners and then set to work speaking with key legislators as they pass. We experienced what Jeff calls “Elevator Speech,” as we stepped onto an elevator and rode it to the 2nd floor of the House of Representatives, allowing Jeff to speak with Minority Whip Chad Campbell regarding the proposed budget cuts and programs which will be cut as a result. At the end of the brief conversation, Representative Campbell walked down the hall and we stepped back onto the elevator. Throughout the morning, Jeff would fill us in on the people he spoke with, the importance of their role at the Capitol and the process that was underway. One is not able to predict the actions of others, but you must be willing to go where you need to be and talk with those necessary to promote your cause. Jeff has an amazing relationship with the legislators; there is a feeling of respect and appreciation for the jobs they both have to do. Jeff is able to, through the support of the Alliance, promote our profession at the Capitol. He develops relationships with the legislators while at the Capitol and fundraisers, as he continues to network on behalf of all those in the profession of pharmacy in Arizona. Jeff Gray and AzPA have a great history. The Alliance was Jeff’s first private client, representing us at the Capitol for four 28 Arizona Journal of Pharmacy

sessions. Jeff knows pharmacy issues. In 2009, Jeff spoke in favor of HB2164 (expanding immunization authority for pharmacists). He provided historical background on the bill to the House Committee on Health and Human Services. “I had no formal training for the position,” Jeff said, when asked to explain what education is necessary for a lobbyist. Jeff’s degree is in Criminal Justice with a minor in Psychology. Using his knowledge obtained from his studies at Northern Arizona University (NAU), Jeff intended to seek a position with a law enforcement agency and become a crisis negotiator. Those who know what Jeff does would argue that his degree has prepared him well for the position - lobbyists are indeed involved in crisis negotiation. The one main difference - as a lobbyist, Jeff does not carry a sidearm. After achieving top honors in his class, Jeff had the opportunity to apply for an internship at the State Capitol. He admitted he applied out of “morbid curiosity.” The application process was intense and Jeff became one of the five interns. He continued with the position once his internship was complete. His boss was an analyst for the Governor; she oversaw all the interns for the Governor’s office. “She was appointed to a policy position, so I took her position as an analyst,” Jeff said. This position lasted for one year until the newly elected Governor appointed her new staff. Jeff was named as the Director of Legislative Affairs for the Department of Housing from 20022006. Under the Department of Housing, he was the State Department of Housing’s federal, state and local lobbyist, as well as press person, for four years. “Handling legislative affairs, any external communication went through my office,” Jeff explained. His unique skill set had positioned him to communicate with legislators and press alike. He reported, “There was a little bit of a learning curve.” In 2006, Jeff made a significant shift in his career as he moved from the public sector of lobbying to the private sector. Jeff has been lobbying for a combined eleven years, the most recent four years as a private lobbyist. When questioned about the differences between the two sectors, Jeff said, “There is more flexibility when lobbying in the private sector. When you’re in the government sector your hands are more tied….you’re a public servant.” “One of the things you’ll find with folks that hire lobbyists is that they have better things to do with their time such as managing their company or association. They don’t have time to dedicate 50+ hours at the Capitol doing this,” Jeff explained. Fortunately for AzPA, Mindy Smith, Executive Director/CEO, recognizes the importance of having a full time lobbyist to safeguard our profession. With the collaboration of Alliance membership, it is possible to retain representation necessary at the Capitol. As professionals, we “don’t have time to dedicate 50+ hours” a week to represent our profession. Thanks to Mindy and Jeff, we do not have to. We are grateful for the dedication Jeff shows to our profession. Please join all of us at the Arizona Pharmacy Alliance in thanking Jeff for continuing to represent our profession at the Capitol.

Features and Articles Evaluation of Alternative Workflow Models for Implementing a Community Pharmacybased Immunization Clinic by Kelly Kistler, Pharm.D., The Apothecary Shops and Michael T. Rupp, Ph.D., Midwestern University - College of Pharmacy Glendale

Introduction Legislation recently passed in Arizona (HB2164) allows certified pharmacists to administer selected vaccinations to patients 18 years and older without a prescription.1 While this represents a significant opportunity for Arizona pharmacists, specialized services like immunizations can also add stress to pharmacy workflows and added responsibilities for already busy staff. Adding a new specialized service like immunizations therefore requires that staffing responsibilities and workflow be considered when designing the new service to ensure that it does not negatively affect the delivery of prescription drugs and other products and services to the pharmacy’s existing client base. On the heels of the enabling legislation in Arizona, management at The Apothecary Shops, a multiple location independent community pharmacy organization, decided to implement immunization services in its Arizona pharmacies. To ensure successful integration of this new service into busy pharmacy operations, management wanted to evaluate alternative models for delivering immunization services to determine which would be most consistent with existing staff responsibilities, pharmacy workflow, and facilities design. Objective The objective of this study was to evaluate alternative models for implementing immunization services in eight Arizona Apothecary Shops pharmacies for its impact on workflow and cost/profitability. Methods Eight Apothecary Shops pharmacies in Arizona were randomly assigned to one of two immunization workflow models: a Limited Walk-in model that provided immunizations on demand during designated store hours, and: an Appointment-only model that required patients to schedule their immunizations in advance. Study participants were pharmacists and technician employees with direct patient care responsibilities between October 2009 and January 2010. All pharmacist immunizers were certified to provide immunizations by the Arizona State Board of Pharmacy. Study methods were approved by the Institutional Review Board of Midwestern University. Prior to implementing the immunization service, anonymous comments were solicited from staff at each of the eight participating pharmacies for any concerns they had about the service and its potential effect on store operations. From the written concerns received, a nine-item survey was constructed to measure attitudes of pharmacy staff toward the service and its perceived impact on key aspects of pharmacy operations. Surveys were completed anonymously at the midpoint and endpoint of the study. Data on personnel time required to deliver the immunization service was collected via direct observation of immunization

staff at each participating pharmacy. Personnel time was then converted to cost using internal pay rates for pharmacists and technicians in the organization.2 Results A comparison of the staff time and costs required to perform immunizations in the two workflow models appears in Figures 1 and 2, respectively. As illustrated in Figure 1, the Appointment Only model involved two additional steps to schedule the immunization and provided a reminder telephone call to the patient and required an average of 17.02 minutes of total staff time to administer a flu vaccine. In contrast, the Limited Walk-in model required only 13.79 minutes of staff time. The difference in staff time fell just short of statistical significance (p=0.0568). Figure 2 illustrates the comparative staffing costs of performing immunizations using the two workflow models. The total staff cost for delivering immunizations was found to be significantly higher in the Appointment Only model at $11.88, compared to the Limited Walk-in model’s cost of $10.37 (p=0.0023). The difference in cost appeared to be due primarily to additional discretionary time that pharmacists in the Appointment-Only model spent with patients following administration of the vaccine (Monitor Patient). Pharmacy staff completed the nine-item attitudinal survey at the mid point and again at the end of the flu season. As illustrated in Table 1, staff in pharmacies that implemented the Appointment Only model demonstrated significantly higher agreement to “Staffing for the flu clinic was adequate” than did staff in the Limited Walk-in model pharmacies at the end of the flu season (p=0.0066). Two additional survey items approached statistical significance, including “The flu clinic did not negatively affect normal workflow” (p=0.0841) and “The flu clinic did not negatively affect the environment inside the pharmacy” (p=0.0607). Discussion When evaluated from the perspective of its acceptability to pharmacy staff, the preferred approach for implementing immunizations at participating Apothecary Shops pharmacies appeared to be the Appointment-Only model. This was due primarily to perceptions about the relative adequacy of available staff to support the service when provided by appointment. However, when evaluated from the perspective of the required staff time to deliver the service, the Limited Walk-in model appeared to be the superior alternative. This was due primarily to amount of time that the pharmacist spent with patients after vaccine administration in the Appointment-Only model. For any new service to be successful in a community pharmacy it is essential that staff is supportive and confident that the service can be integrated into the practice without negatively affecting existing operations. At the same time, if the service is to be financially sustainable it is important that service-related costs are kept to a minimum. The results of this project suggest that management at The Apothecary Shops must choose between optimizing these two objectives when selecting the workflow model that will be used to implement immunizations across the organization. Alternatively, management could elect to implement the Appointment-Only model and encourage or require pharmacists Arizona Journal of Pharmacy 29

Features and Articles Evaluation of Alternative Workflow Models (continued from page 26) to limit the amount of time they spend with patients following administration of the vaccine. However, while such a strategy may improve the cost efficiency of this model, it may have a negative effect on staff support as this discretionary time may be a key factor in the preference enjoyed by this model among staff. An important limitation of this project was that although immunization models were randomly assigned, the eight participating pharmacies differed significantly by size, layout and staffing. Given the relatively small sample size, these differences

30 Arizona Journal of Pharmacy

may have influenced the results. Although not a limitation of the study per se, a relevant consideration in the evaluation of any new patient care service that was not addressed in this study is its acceptability to patients. Future research should include comparative assessments of patient satisfaction among alternative approaches to implementing new pharmacy services. References: 1. House Bill 2164. State of Arizona, House of Representatives. Forty-ninth Legislature, First Regular Session 2009. 2. Rupp MT. “Analyzing the Cost of Delivering Value Added Pharmacy Services” in Buying a Pharmacy: A ‘How-To’ Guide, NCPA Management Institute, 2008.

Features and Articles 18th Century English Apothecary Jar by Robert E. Kravetz, M.D., FACP, MACG Archivist, American College of Gastroenterology

Storage containers for drugs were an essential for the practice of early pharmacy. Appropriate storage was necessary for crude and dried drugs as well as for liquid preparations that were made from the herbs. Prior to the late 1800s, apothecaries, forerunners of today’s pharmacist, prepared medicines in full view of their customers and this required containers that were both functional and attractive. Containers were fashioned from plain lead-glazed earthenware, metal, or wooden boxes prior to the 1500s. The development of a tin glaze (a mixture of tin, lead and potash) enabled potters to produce much more attractive containers that concealed the plain gray body of the earthenware jar. Blue and white coloring came from the oxides used in the glaze. The unglazed pot was fired at a low temperature and then dipped into the glaze to which tin oxide was added that produced a white opaque finish. When dry, designs were painted with a cobalt oxide, which produced a blue color once the second firing took place. Note the attractive and pleasing appearance of this illustrated ointment jar. Early containers were plain, straight-sided jars with simple decorations. Later apothecaries used bulbous jars with a splayed pedestal foot and lip. Parchment, secured with twine, protected the contents on earlier jars and later they had both metal and ceramic lids. Starting in the middle of the 1600’s, designs became more elaborate and displayed a plaque or cartouche featuring an abbreviated Latin form of the name of the jar’s contents. Decorative designs such as an angel with outspread wings, cherubs or songbirds were used and, to some degree, the different designs help to date the jars. Earthenware made with the white and blue tin-glaze technique is sometimes referred to as Delft and includes both English and Dutch products. The majority of potters working in England were Flemish in origin, making it difficult to separate English from the Dutch. The manufacture of tin-glazed drug jars began to decline by the mid-1700’s and intact jars are a rare find. This surviving ointment jar dates from circa 1770 and on today’s market would be valued at $2,000. Its rarity was unknown to the former owner who used it as a pencil holder. Ung. Sambucin (Sambucus) refers to an ointment made from the elderberry tree that is native to Europe but also grown in the United States. The tree has been called the “medicine chest” of the common people. For centuries, traditional folk medicine has used the flowers, leaves, berries, bark and roots of this tree. Historical usages of the ointment have included salves for skin conditions, poultices for engorged breasts, and a soothing ointment for wound healing. In liquid form, when ingested, it has been used as both an emetic and cathartic, for treating heart disease, a blood purifier, treating colic and for reduction of fever. Elderberry wine was and is still taken as a medicinal tonic; as a culinary plant, elderberry has long been used in jams, jellies, chutneys, and preserves. Today it continues to be prescribed by naturopaths and is found in health food establishments that sell botanical herbs.

18th Century English Apothecary Jar from the author’s private collection.

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Arizona Journal of Pharmacy 31

Rx and the Law AND THE LAW by Don R. McGuire, R.Ph., J.D. This series, Pharmacy and the Law, is presented by Pharmacists Mutual Insurance Company and your State Pharmacy Association through Pharmacy Marketing Group, Inc., a company dedicated to providing quality products and services to the pharmacy community.

NEVADA RULES ON PHARMACIST’S DUTIES The Nevada Supreme Court has ruled on the case asking whether seven chain pharmacy owners and one independent owner were rightfully dismissed from the civil case, Sanchez v. Wal-Mart Stores, et al1 . The case arises from a June 2004 car accident caused by Patricia Copening. She was driving along a busy Nevada highway while under the influence of prescription medications. The accident killed one man, Gregory Sanchez, Jr., and injured another, Robert Martinez. Prior to the accident, in June 2003, the Nevada Prescription Controlled Substance Abuse Prevention Task Force sent letters to 14 Las Vegas area pharmacies informing them that Copening may be abusing drugs. The letter informed the pharmacies that Copening had received approximately 4,500 hydrocodone tablets from 13 different pharmacies during the previous year. She continued to receive multiple prescriptions for hydrocodoneacetaminophen and carisoprodol between June 2003 and June 2004 when the accident occurred. She appeared confused. The police found prescription bottles and loose tablets in the vehicle. She was found to have hydrocodone in her system. She served nine months in jail after pleading guilty to reckless driving. A civil case was filed by the Sanchez family, Mr. Martinez and his family against Copening, the doctors prescribing for her, and the pharmacies. The district court dismissed the pharmacies because Nevada law did not impose a duty on the pharmacies to take action after receiving the Task Force letter. The Supreme Court of Nevada reviewed the case and answered two questions; First, did the pharmacy have a duty to act to prevent their patient from injuring members of the general public, and Second, did Nevada law allow third parties to maintain a negligence per se claim. The case was decided by a 5-2 margin, with a strong dissent. The majority and the dissent agreed that under Common Law principles, a person has no duty to control the dangerous conduct of another person or to warn others of the dangerous conduct. There is an exception to this rule however. If there is a special relationship and the harm is foreseeable, the there is a duty to act. The majority and dissent diverged on the analysis of whether a special relationship existed in this case because they weren’t consistent on which parties form this special relationship. The majority talked about the relationship between the pharmacy 32 Arizona Journal of Pharmacy

and the victim, while the dissent talked about the relationship between the pharmacy and the patient. The majority notes that the pharmacy had no relationship with the victims and that they were, in fact, unidentifiable prior to the accident. This is an important point in the analysis because it is clear that there is a special relationship between a pharmacy and its patients. The majority noted that the pharmacy had no requirement to act after it received the Task Force letter. However, they pointed out in a footnote that the regulations had changed since this incident, but declined to opine as to whether the decision would be different because of the rule changes. The ruling in the case was that the pharmacies had no duty to act because the law didn’t require them to act and there was no special relationship formed that would require them to act. The majority also ruled that a negligence per se claim could not be maintained because the laws in question were not intended to protect against the injuries that the plaintiffs had sustained. While the pharmacies were dismissed in this case, the case should serve as a wakeup call to pharmacists. The dissent made some strong arguments, and even the majority hinted that the answer might be different under today’s laws. The court here said that the pharmacies did not have a duty to act upon information received from the task force, so they never provided guidance as to what a pharmacy should do if it were required to act. This issue is very likely to come up again and the next court could find that the pharmacy was required to act. Prescription drug monitoring programs work by providing information that a single pharmacy or prescriber is unlikely to obtain on their own. In the past, a single pharmacy was usually unaware of all of a patient’s activities in acquiring controlled substances and didn’t have enough information to take any action. In the present case, the pharmacies were notified that the patient was getting prescriptions filled at 12 other pharmacies around town. It is very possible that this additional information might provide the basis for a court or legislature to make a major change in the law of negligence. 1. Sanchez, et al. v. Wal-Mart Stores, Inc., et al., 2009 WL 5030703 (Nev.), December 24, 2009.

© Don McGuire, R.Ph., J.D., is a Professional Liability Claims Attorney at Pharmacists Mutual Insurance Company. This article discusses general principles of law and risk management. It is not intended as legal advice. Pharmacists should consult their own attorneys and insurance companies for specific advice. Pharmacists should be familiar with the policies and procedures of their employers and insurance companies, and act accordingly.

Continuing Education

Opportunities for Drug Information and Use Standards

Council of the Convention Section on the Quality of Patient Care Rita Munley Gallagher, Ph.D., R.N., Section Chair (American Nurses Association), Thomas R. Clark, R.Ph., M.H.S. (American Society of Consultant Pharmacists), Charles W. Maas, M.D., M.P.H. (California Medical Association), Stephen P. Spielberg, M.D. (Association of American Medical Colleges)

Goals: The goals of this lesson are to review USP’s contributions to the provision of information supporting rational therapeutic decision-making and safe medication use, focusing on the general topic of drug information and use standards. Objectives: At the conclusion of this lesson, successful participants should be able to: 1. Recognize the role USP has played in providing drug information 2. Describe new opportunities that USP is exploring for drug information and use standards INTRODUCTION As a standards-setting organization for medicines and other healthcare articles, the United States Pharmacopeial Convention (USP) has contributed broadly and deeply to the provision of information supporting rational therapeutic decisionmaking and safe medicine use. In this white paper, USP’s Council of the Convention Section on the Quality of Patient Care provides a situation analysis of these and allied contributions, focusing on the general topic of drug information and use standards. A separate white paper will consider safe medication use. Standards generally apply to people, processes/practices, and/or products. USP now provides an extensive array of product standards for drug and food articles in the United States Pharmacopeia (USP), National Formulary (NF), Food Chemicals Codex (FCC), and allied compendia. These product standards support testing to assure identity, strength, quality, and purity of foods and drugs. Beyond these product standards lie others that support rational therapeutic use— process and practice standards—and perhaps clinical practice standards as well that can be associated with education and training. Process/practice standards also might promote improved operations of healthcare teams and systems. This paper uses the term drug information and use standards to define collectively the

concept of standards to promote rational and cost-effective therapeutic decisionmaking for medicines. Such standards could be applied in the paradigm that moves from diagnosis to treatment. Once a diagnosis is made, many therapeutic guidelines exist; many are maintained on an Agency for Healthcare Research and Quality (AHRQ) web page at http://www. ahrq.gov/clinic/, that speak to multiple treatment interventions ranging from the extremely simple to the highly complex. Use of medicines also ranges from the simple to the complex, and the complexity in an era of biomolecules and molecular medicine is increasing by the year. Typically, information and use standards for medicines begin with Food and Drug Administration (FDA)-approved efficacy and safety information in drug labeling. This information is amplified over time with further studies and clinical usage. How this further information is generated and applied is a subject of considerable societal interest. It relates not only to rational therapeutic decisionmaking but also to payor and quality of care needs and decision-making. Such information is needed more critically now than ever before. The cost to provide continuing information and standards about a medicine is borne primarily by the private sector—and increasingly the information itself is a web-based commodity. Multiple compendia provide a basis for reimbursement, and many hundreds, if not thousands, of pharmacy and therapeutic committees provide administrative decisions to support cost-effective treatment for defined populations. USP’s foray into drug information and use standards might build on the organization’s ongoing responsibility for maintenance of the Medicare Model Guidelines. Many other organizations also are involved in such standards, and USP would necessarily ally with them in its “neutral convenor” role in any further standards-setting attempts. Increasingly, as a dominant payor, the United States Federal government is involved, and a public-private model of

some sort might be optimal. If such a model is considered, financing, scope, governance, and many other questions and challenges will arise. With the exception of the everythree-year Medicare Model Guidelines updates, or the most part, USP has exited activities associated with the provision of drug information and use standards. The larger question for the organization now relates to its specific role as a practitionerbased, volunteer-driven, standards-setting organization. USP can do anything it wishes in the way of drug information and use standards, being bound only by resource constraints. The issues for consideration in this white paper might thus be: • In an era of health care crisis and reform, what are the societal needs for drug information and use standards to support rational therapeutic decisionmaking? • If these needs can be defined and USP, by virtue of its structure and history, can uniquely fulfill them—with availability of adequate resources— does it have a responsibility to do so? USP’S HISTORY IN DRUG INFORMATION 1. UNITED STATES DISPENSATORY When the first United States Pharmacopeia (USP) appeared in 1820, it deliberately excluded most explanatory material regarding preparation techniques, which the authors considered to be too rudimentary. However, a need did exist for a Dispensatory—a volume that would not only select official drugs and provide recipes for preparations, but would also give full descriptions and indications of the drugs and explain applicable practitioner techniques. George B. Wood and Franklin Bache, two of USP’s founding physicians, produced the first Dispensatory of the United States of America (USD) in 1832. They viewed its purpose as both instructional (for poorly trained physicians and pharmacists) and as a means to solidify the national authority Arizona Journal of Pharmacy 33

Continuing Education (continued from page 33) of the USP, to which the USD deferred. The USD went on to become one of the most popular American medical reference books of the 19th century, overshadowing the USP itself in terms of everyday usage. The USD continued to be popular well into the 20th century, but started to lose its authority with the rise of the Food and Drug Administration and other sources of drug information as they emerged. Its link to the USP was formally severed in 1880. The last (27th) edition of the USD was published in 1973. 2. USP DI SERIES The USP Drug Information resource (USP DI) was created in 1980 as a complete, unbiased compilation of clinically relevant information about therapeutic products, for the use of practitioners (physicians, nurses, pharmacists) and patients. USP DI was recognized in the Social Security Act as an authority for reimbursable off-label use under Medicare and Medicaid. It comprised three volumes—USP DI Volume I: Drug Information for the Health Care Professional; USP DI Volume II: Advice for the Patient, and USP DI Volume III: Approved Drug Products and Legal Requirements. Originally produced in print format only, a USP DI product line extension in the form of an interactive laser disk focusing on a single disease (About Your Diabetes) was attempted in the late 1980s. Maintenance proved a costly and time-consuming hurdle, and the disk was discontinued in the mid-1990s. Another attempt to move the USP DI into the increasingly important online delivery mode was attempted in 1994, when USP acquired the Drug Evaluations database from the American Medical Association (AMA-DE). The goal was to integrate the AMA-DE data into the USP DI database. Again, technical complexity and the difficulty and expense of maintenance led to the project’s termination. A third attempt to develop a USP DI relational database was launched in the mid-1990s, this time contracting with Carepoint, a provider of pharmacy management software. Yet again, the program was abandoned due to technical complexity and costs. In 1998, USP sold the USP DI database and licensed the USP DI trademark to Thomson Healthcare, but retained editorial oversight of the off-label 34 Arizona Journal of Pharmacy

use material in the publication. In 2000, Thomson launched the USP DI Desktop Series CD ROM, capturing a “large share” of healthcare web portal and hospital web site segments with USP DI branded content. However, changes in some state pharmacy regulatory requirements in 2001 resulted in a sharp decline in the number of pharmacies ordering the product. In addition, the chain pharmacy market was demanding a single vendor for all electronic solutions, which the Thomson USP DI could not provide. USP and Thomson explored a variety of strategic options over the next few years, but ultimately it made the most financial and operational sense for USP to exit the business completely. In 2004, the USP DI Volume I and Volume II became the responsibility of Thomson Healthcare. Under the agreement, Thomson could edit, create content, and publish these texts under the USP DI name until the 2007 edition, after which Thomson’s right to use the name ceased. USP DI Volume III continued to be owned in its entirety by USP. Thomson continues the USP-DI product under the name DrugPoints. Many other entities have provided drug information in various compendia to support sound therapeutic decisionmaking. An analysis of these types of compendia appeared in a series of three articles earlier this year in the Annals of Internal Medicine; a summary editorial references the three articles1. Overall these articles and summary editorial are generally critical of the various compendia in terms of their currency, consistency, and other factors. 3. MODEL GUIDELINES The Medicare Modernization Act (MMA) of 2003 defines the role of USP (Section 1860D-4(b)(3)(C): (ii) MODEL GUIDELINES – The secretary shall request the United States Pharmacopeia to develop, in consultation with pharmaceutical benefit managers and other interested parties, a list of categories and classes that may be used by prescription drug plans under this paragraph and to revise such classification from time to time to reflect changes in therapeutic uses of covered part D drugs and the additions of new covered part D drugs. In addition, Section 1860D-11(e)(2)(D) creates a “safe harbor:”

(ii) USE OF CATEGORIES AND CLASSES IN FORMULARIES – The Secretary may not find that the design of categories and classes within a formulary violates clause (i) if such categories and classes are consistent with guidelines (if any) for such categories and classes established by the United States Pharmacopeia. With this legislative mandate and on behalf of the Secretary of the Department of Health and Human Services, the Centers for Medicare and Medicaid (CMS) awarded USP a cooperative agreement to develop and revise the Part D Prescription Drug Benefit Model Guidelines. A new Model Guidelines Expert Committee was formed to accomplish the task. While the MMA did not specify the frequency of updates to the Guidelines (“…from time to time…”), the Expert Committee and CMS agreed that an annual update was appropriate given the rapidly evolving nature of pharmaceuticals. Version 1.0 was a large effort, involving a review of how other formularies are categorized and presented. At its highest usage (2006), 74% of health plans were using the USP Model Guidelines (Version 1.0). The Model Guidelines Categories and Classes provided a formulary structure that helped ensure beneficiary access while preserving needed flexibility for pharmacy benefit managers (PBMs) and health plans. USP developed an additional component to the Model Guidelines: Formulary Key Drug Types (FKDT), which offered additional protection for beneficiaries and a useful tool for CMS in reviewing formularies. Although not mandatory, the FKDT have been utilized by CMS as part of its Formulary Review Guidance, and serve as standards that promote consistency, fairness, and ease of administration. Usage of the Model Guidelines lessened in subsequent years, primarily due to plan consolidation and a broader use of internal classification systems due to plans’ comfort with the CMS process. Nevertheless, the guidelines contributed substantially to the availability of a comprehensive, yet affordable, benefit. As with all its standards, USP actively solicited and welcomed participation and input on Guidelines development from interested stakeholders, including manufacturers, drug plans, practitioners,

Continuing Education (continued from page 34) and patients. USP’s experience with the Model Guidelines was summarized in a report published in Annals of Internal Medicine in 20062. Its work on behalf of the Federal government followed a primary activity where USP participated in a consortium of interested organizations to produce a document entitled “Principles of a Sound Drug Formulary System” (2000)3. By 2008, CMS decided that the Guidelines had achieved a significant level of success and stability. Based on this, USP and CMS agreed to move from an annual revision timeline to a three-year cycle. CMS continues to use the current Model Guidelines and FKDT through plan year 2011, and USP is maintaining the current versions on its web site. The goal is for USP to start work on Version 5.0 in 2010. EXPLORATION OF NEW OPPORTUNITIES 1. DRUG INFORMATION CONSULTATIONS In 2005 and again in 2006, USP convened special meetings, called Drug Information Consultations, where individuals and organizations gathered to discuss the feasibility and advisability of developing practice standards associated with drug information. In these meetings, USP sought a clear understanding of the current gaps in drug information and where its standards-setting expertise might be used to augment information used by practitioners, plans, and patients in decision-making about rational drug use. At the time of these meetings, USP was engaged in the development of Model Guidelines for the Medicare Prescription Drug Benefit and was considering how that activity might also be supported with additional drug information for the healthcare community. Despite a number of useful suggestions from a broad range of participants, these consultations did not generate any specific activity (notes of meetings are available). A Board Task Force (2005-2010) was formed to monitor USP’s interests in the topic. 2. APPLIED DRUG INFORMATION RESOURCE Working with the American Medical Association, the American Nurses Association, and the American Pharmacists Association, USP led a series of meetings that explored the concept of an Applied Drug Information Resource

(ADIR). The general idea for the ADIR was to advance “personalized medicine” concepts, in which general information about a medicine would be adjusted by patient-specific characteristics. The product would yield information directed to diverse practitioner and patient constituencies. The opportunity did not progress. 3. COMPARATIVE EFFECTIVENESS Comparative effectiveness (CE) studies of specific treatment approaches— including various pharmacotherapies, lifestyle changes, imaging procedures, and surgical interventions—have great current and potential value. They add to the body of knowledge that helps health care practitioners, as well as patients and their families, make treatment decisions. The infusion of funds (through the American Recovery Reinvestment Act of 2009, also known as the “Economic Stimulus” Legislation) that will support additional research is a welcome development. The bill provides $1.1 billion for CE research: • $300 million to the Agency for Healthcare Research and Quality (AHRQ); • $400 million to National Institutes of Health (NIH); and • $400 million to the Department of Health and Human Services (DHHS). • Observations about this funding that are relevant to USP include: • Organizations can make proposals for CE project funding (the process is still being determined by agencies). • According to the conference report, funding is not to be used to mandate coverage decisions, but instead is for generating useful research comparing clinical outcomes. • The law also establishes the Federal Coordinating Council for Comparative Effectiveness Research, made up of high-level government officials, for the purpose of coordinating healthcare research across the Federal government. • IOM has engaged the community in a better understanding of the types of CE studies needed.4 • AHRQ has conducted workshops and engaged in other tasks to generate evidence-based information and engage the community in understanding how database analyses can generate useful CE information.5

CE studies per se will be valuable and must, more frequently, become one of the inputs used by practitioners and patients to guide therapy following diagnosis, despite the fact that CE is sometimes linked in public discourse to rationing of healthcare. Diagnosis and treatment can be aided by development of a treatment model— captured and presented as a generally applicable set of process standards—that addresses key aspects of the decisionmaking process that are often considered in an ad hoc fashion, if at all. In turn, these process standards support treatment programs (protocols) to guide the practitioner and patient/consumer alike. These treatment programs themselves are also process standards that are frequently lacking for the individual patient when he or she leaves the immediate healthcare provider’s setting. 4. PHARMACOTHERAPY GUIDELINES Comparative Effectiveness results could be put into action through extended pharmacotherapy treatment standards. USP could serve as a convener of organizations to 1) develop an innovative, multidisciplinary, patient inclusive approach for integrating CE research study outcomes into pharmacotherapy standards/guidelines—treatment program standards— and 2) apply this approach to two separate, established, model standards or guidelines for particular disease treatments. Aspects/features of the approach include: • AHRQ-funded evidence-based studies, including CE studies; • Conferences and Webinar(s); and • Disease/condition candidates for which a wide range of treatment therapies exist, the cost of therapies varies widely, and which are part of a discrete patient population that would be affected. In all cases, transparency of work would be emphasized, partners would represent the interdisciplinary health care team (including patients and payors), and USP committees and members would be part of the process. 5. SPECIALTY MEDICINES Specialty medicines are the product of innovative technologies (often, but not solely, biotechnology engineered Arizona Journal of Pharmacy 35

Continuing Education (continued from page 35) molecules) that target unmet medical needs and are expensive because of limited patient populations, high cost of manufacture, and the increased risk and cost of development programs. In addition, the forced evolution of the pharmaceutical industry business model from reliance on historically successful but fading “blockbusters” to larger numbers of innovative specialty medicines requires higher prices to fuel growth. Exacerbating the cost problem is that, as a consequence of structural and financial realities in the approval process and the costs and risks of development, these medicines are often used for unapproved indications for which evolving data sets are suboptimal when compared with data supporting their use in approved indications. Such use is generally for chronic, inadequately treated diseases with high morbidity and mortality, creating compelling demand for utilization and making it difficult to deny access. Access may seem arbitrary, depending upon the sophistication of the practitioner and patient in confronting the payor, which contributes to a growing sense of unfairness. The payment for these medicines varies considerably among plans. Medicare covers specialty pharmaceuticals under Parts B and D, depending upon seemingly unrelated factors, including the route and place of administration. Therefore, care may be driven by reimbursement rather than clinical considerations. Both private and public (Medicare) payors use tier structures (essentially a cost shift to patients) to reimburse for these medicines. Since Medicare Part B (and most private plans) lacks out-of-pocket maximums and these medicines can cost tens of thousands of dollars per year, they are simply unaffordable for many under the current system. To effectively allocate scarce health care resources, standards are needed to support rational therapeutic use of specialty medicines. These standards are now left to individual pharmacy and therapeutics committees, their health plans, and/or individual practitioner and patient decision-making. The question arises whether a national process could lead to standards to better inform these decisions. 36 Arizona Journal of Pharmacy

The sensitive and inevitably controversial nature of these standards requires that this process be inclusive, transparent, and objective. USP possesses a structure and history that uniquely position it to achieve these objectives. 6. INFORMATION STANDARDS USP’s Information Expert Committee chairs have advocated that USP provide information standards rather than the information itself. Such standards would serve as a framework within which others could create information. This concept relates directly to USP’s standards-setting and practitioner-based character and links the quality of patient care to the quality of the information used by healthcare professionals and patients. Examples of information standards (as distinct from information) could include the adequacy of research study design, methodology, analysis, and communication of results. Other standards could include: • Linguistic competency for verbal or aural messaging and comprehension targeted at specific audiences, e.g., level of language used, languages available, visual depictions, words presented per minute; • Cultural sensitivity in messaging: ethnicity, gender, age, etc.; • Ethics in targeting vulnerable populations: elderly, children, terminally ill; • Competency in decision-making: use of duress, undue influence, physical and mental capacity, etc.; • Patient–provider relationships and conflicts of interest; • Direct to patient advertising: "free" samples; and • Requirements for post-regulation marketing surveillance. 7. NATIONAL AND INTERNATIONAL APPROACHES Through its Essential Medicines List, the World Health Organization (WHO) has sought to provide a limited list of medicines to decrease inappropriate prescribing and promote rational use.6 The WHO Essential Medicines List is used by many nations throughout the world to create national formularies that expand and/or contract the WHO list to meet local needs. In principle, USP’s Model Guidelines provides a “table of contents” for a U.S. national formulary. Combining the approach with the AMA-

DE in evaluating individual medicines within each category and class of the Model Guidelines further supports a U.S. national formulary, which does not now exist. The opportunities and challenges of such an approach are generally well known. An essential medicines list speaks to the best medicines within a country, region, or even the globe. In this context, it speaks to official medicines in the United States Pharmacopeia, which were always intended to be the best medicines. The National Formulary in the United States provided quality standards for non-official medicines. It was adopted by USP in the 1970s and has evolved into a book of excipient monographs. A seminal paper by T. Donald Rucker, Ph.D., argued that USP should advance a “true” national formulary in the U.S.7 SUMMARY At the outset, this white paper asked the following questions: • In an era of health care crisis and reform, what are societal needs for drug information and use standards to support rational therapeutic decisionmaking? • If these needs can be defined and USP, by virtue of its structure and history, can uniquely fulfill them—with availability of adequate resources— does it have a responsibility to do so? The U.S. Federal government has turned to USP’s standards-setting activities and expertise on many occasions over more than 100 years, not only when it recognized USP and NF as official compendia of the United States, but also for purposes of reimbursement on two occasions8 and, more recently, to assure beneficiary access in the Medicare Part D legislation. In these cases, USP was recognized as a trusted, neutral organization that could bring together diverse stakeholders and make objective, science-based decisions through an open and transparent process. In the current state of healthcare reform and crisis, it may be time to call upon USP again. There is a deep logic, expressed in many countries over many years, for governments to seek non-governmental practitioner experts to achieve a public health good, such as drug information and use standards. But even if the U.S. Federal government does not turn to USP at this juncture, this does not mean that

Continuing Education (continued from page 36) USP should not act. While USP has a need for sufficient financial resources to set drug use and information standards, it has access to the greatest resource of all: a cadre of healthcare experts from around the world who have, can, and could set, through activities of the Council of Experts, drug information and use standards in ways that would speak profoundly to patients and practitioners in a time of great need. The Council of the Convention Section on the Quality of Patient Care seeks creative thinking about a strengthened role for USP in setting drug use and information standards. Comments on this white paper may be submitted to CoC@usp.org. References 1.Sox, HC. 2009. Editorial: evaluating off-label use of anticancer drugs. Annals of Internal Medicine, Volume 150, Number 5 2. Narrative review: the US Pharmacopeia and Model Guidelines for Medicare Part D Formularies. USP Model Guidelines Expert Committee, USP Staff [Williams, RL] Ann Intern Med 145, 448–453 (2006) 3. http://www.usp.org/hqi/patientSafety/resources/ soundFormularyPrinciples.html 2009 4. www.iom.edu/cerpriorities (July 2009) 5. http://www.ahrq.gov/clinic/outcomix.htm (July 2009) 6. Reidenberg, MM. Can the selection and use of essential medicines decrease inappropriate drug use?. 2009.

Clinical Pharmacology and Therapeutics, Volume 85, Number 6. 7. Rucker, TD. November 15, 1999. A public-policy strategy for drug formularies: preparation or procrastination?.American Journal of Health-System Pharmacists, Volume 56. 8. Omnibus Budget Reconciliation Act of 1990 (Public Law 101-508) signed into law November 5, 1990 and The Omnibus Budget Reconciliation Act of 1993 (Public Law 103-66) 107 Stat. 312, enacted August 10, 1993. http:// assembler.law.cornell.edu/usc-cgi/get_external. cgi?type=pubL&amp;target=103-66 ), ( http://www. answers.com/topic/united-states-statutes-at-large )

ACPE UAN #0100-999-10-022-H04-P This continuing education monograph is adapted from the United States Pharmacopeial Convention (USP) series of white papers prepared by the Council of the Convention (CoC) titled “Focus On: Future Directions for USP.” The learning objectives and assessment questions were developed by National Alliance of State Pharmacy Association’s (NASPA) Continuing Education Advisory Panel. No financial support was received for this activity. This activity may appear in other state pharmacy association journals. ABOUT USP and NASPA The United States Pharmacopeia (USP) is an official public standards–setting authority for all prescription and over–

the–counter medicines and other health care products manufactured or sold in the United States. USP also sets widely recognized standards for food ingredients and dietary supplements. USP sets standards for the quality, purity, strength, and consistency of these products–critical to the public health. USP's standards are recognized and used in more than 130 countries around the globe. These standards have helped to ensure public health throughout the world for close to 200 years. More information can be found at www.USP.org The National Alliance of State Pharmacy Associations (NASPA) promotes leadership, sharing, learning, and policy exchange among state pharmacy associations and pharmacy leaders nationwide, and provides education and advocacy to support pharmacists, patients, and communities working together to improve public health. NASPA was founded in 1927 as the National Council of State Pharmacy Association Executives (NCSPAE). More information can be found at www.naspa.us Reprinted with permission. Copyright 2009, The United States Pharmacopeial Convention. All rights reserved.

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Arizona Journal of Pharmacy 37

Continuing Education

Oral anticoagulation without protimes: A review of two emerging agents that may come to market

Lindsay Davis, Pharm.D., Acute Care Pharmacy Resident, Phoenix VA Medical Center, Phoenix, AZ Goals: ANTICOAGULANTS within the body. The goals of this lesson are to provide Currently the US market has nine INDICATIONS FOR an overview of two emerging oral FDA approved agents for anticoagulation ANTICOAGULATION THERAPY anticoagulants and address their potential Common indications for anticoagulation therapy, each with differing indications and place in therapy should they be approved limitations (Tables 1 and 2). therapy include prevention of by the FDA for the U.S. market. Published Warfarin depletes vitamin K dependent cardioembolic stroke in patients with clinical trial data will be presented to clotting factors II, VII, IX, and X thereby atrial fibrillation or mechanical heart assess the safety and efficacy of these effectively inhibiting both the intrinsic and valve prosthesis, and in the treatment and agents compared to currently available extrinsic pathways of coagulation.1 Since prevention of venous thromboembolism anticoagulants. 1954, the vitamin K antagonist (VKA) (VTE) which consists of deep vein warfarin has been and remains the only thrombosis (DVT) and pulmonary Objectives: available oral anticoagulant on the U.S. embolism (PE). The vast majority At the conclusion of this lesson, successful market. Challenges associated with use of of the patient population undergoing participants should be able to: warfarin include the need to individualize anticoagulation therapy falls into one 1. Review elements of the clotting cascade the dosage due to its unpredictable of these categories. The emerging and clotting terminology. anticoagulant effect, multiple food & anticoagulants referred to in this article 2. List the most common indications for drug interactions, and narrow therapeutic will be discussed in terms of the risks and anticoagulation therapy. benefits of these novel agents as they relate window.1 Warfarin therapy requires regular 3. Identify reasons why new oral monitoring of the patient’s international to these disease states. anticoagulants could be beneficial in normalized ratio (INR) to maintain safety COAGULATION CASCADE clinical practice. and efficacy. This monitoring requires The human body utilizes an elaborate 4. Define the mechanism of action of the system of proteins & feedback mechanisms trained medical professionals who are two emerging anticoagulants discussed. diligent with, at minimum, monthly followto maintain homeostasis in regard to 5. Based on presented clinical trial data, up with patients. bleeding and clotting. This coagulation be able to describe the benefits and risks Heparin potentiates the actions of system relies on communication of tissues associated with each new agent. antithrombin III. Antithrombin III and coagulant proteins (clotting factors) INTRODUCTION inactivates thrombin (factor IIa) and factors that provide both a means to repair Anticoagulants are essential components wounds (fibrin clot formation) and degrade IXa, Xa, XIa, and XIIa.1 The actions of in the medical management of conditions heparin inhibit the propagation of the clots once the tissues have been fully including the prevention and treatment of intrinsic and final common pathways of repaired (fibrinolysis).1 The clotting and thromboembolic disorders such as deep the coagulation cascade. Drawbacks to fibrinolytic system is an intricate series of vein thrombosis and pulmonary embolism the use of unfractionated heparin (UFH) successive protein activation and is called and in the prevention of cardioembolic include route of administration (intravenous the “coagulation cascade”, see Figure events such as stroke from atrial fibrillation. 1. The coagulation cascade consists of or subcutaneous) and unpredictable These conditions carry with them anticoagulant effect due to unspecific two primary pathways, the intrinsic and significant morbidity and mortality. For binding.1 The unpredictable anticoagulant extrinsic pathways, which both lead to the patients requiring long-term anticoagulation final common pathway and ultimately fibrin effect of UFH requires regular monitoring therapy there is only one oral anticoagulant of the activated partial thromboplastin time clot (thrombus) formation.1 Inhibition of available on the U.S. market, warfarin, the activity or production of clotting factors (aPTT) and careful dose titration by skilled which has many challenges associated with providers.1 Additionally, heparin carries results in disruption of the coagulation its usage. All other available anticoagulants cascade and decreased thrombus formation. the paradoxical risk of thrombosis called require either intravenous or subcutaneous heparin-induced thrombocytopenia (HIT).1 Current and emerging anticoagulants alter administration which can be inconvenient Low-molecular weight heparins different steps within the clotting cascade or worrisome to patients. New oral (LMWHs) such as enoxaparin, dalteparin, either by decreasing the production of anticoagulants are being developed that and tinzaparin cause antithrombin clotting factors (e.g. warfarin), through will hopefully be more efficacious than III-mediated inhibition of factor Xa indirect inhibition of clotting factors (e.g. those currently available while maintaining and, to a lesser extent, inhibition of heparin, low-molecular weight heparins, favorable pharmacokinetic and safety thrombin (factor IIa)1. Limitations to fondaparinux), or through direct inhibition profiles. Due to the inherent risks of anticoagulation treatment with LMWHs of clotting factors (e.g. direct thrombin interfering with the body’s clotting system, include the requirement of subcutaneous inhibitors).1 Simply stated, anticoagulants no anticoagulant will be without risk. That administration, risk of accumulation of drug slow the rate of coagulation. A common said, the goal of anticoagulation therapy is with renal impairment, and risk of HIT.1 misconception is that anticoagulants to minimize risk and maximize safety while prevent clotting or cause bleeding. The indirect factor Xa inhibitor, reducing complications of clot formation fondaparinux, exerts its anticoagulant MECHANISM OF ACTION effects through antithrombin III mediated OF CURRENTLY AVAILABLE 38 Arizona Journal of Pharmacy

Continuing Education (continued from page 38) selective inhibition of factor Xa.1 Limitations to fondaparinux include requirement of subcutaneous administration and the risk of drug accumulation with renal impairment.1 EMERGING ANTICOAGULANT AGENTS As discussed, there are many limitations and undesirable attributes to the currently available anticoagulants on the U.S. market today. A novel oral anticoagulant that could provide equivalent or superior efficacy and similar or enhanced safety would be a beneficial addition to current therapy options. An agent that does not require regular measurement of clotting times (e.g. INR, aPTT) would also be preferable. Table 3 lists desired attributes for newly developed anticoagulants. Dabigatran and rivaroxaban are two oral anticoagulants that are being developed for the treatment of various clotting disturbances. According to ClinicalTrials.gov there are currently 19 trials involving dabigatran and 25 trials involving rivaroxaban in various stages of completion.2 These agents are being studied for the prevention of cardioembolic stroke due to atrial fibrillation, in the treatment and prevention of venous thromboembolism, and in the medical management of acute coronary syndrome. Even though these agents have not been approved by the FDA and are therefore not available in the U.S. at this time, there are several published clinical trials that offer insight into the possible risks and benefits of their use. DABIGATRAN Dabigatran is an oral direct thrombin inhibitor.3 It was approved for use in Europe and Canada in 2008 for venous thromboembolism (VTE) prophylaxis in elective total hip and total knee replacement (THR/TKR) in 2008 under the brand names of PradaxÂŽ and PradaxaÂŽ, respectively.4 Dabigatran binds specifically to thrombin and has little effect on other clotting factors.4 By binding to the active site of thrombin, dabigatran inhibits the conversion of fibrinogen to fibrin, thereby blocking the final step of the coagulation cascade and thus fibrin clot formation. Dabigatran has a unique pharmacokinetic profile (see Figure 1). Dabigatran etexilate is given orally and is converted into its active metabolite, dabigatran, after absorption from the gastrointestinal tract. The bioavailability

of dabigatran is very poor and absorption is dependent upon an acidic enviornment.3 To overcome this, the manufacturer designed a capsule containing pellets with a tartaric acid core and coated with dabigatran etexilate.5 This creates an acidic microenviornment that improves dissolution and absorption of the drug independent of gastric pH.5 The prodrug dabigatran etexilate is hepatically converted into two active metabolites, dabigatran glucuronide which is excreted through the biliary system, and dabigatran which is renally eliminated.5 Because of the extensive renal elimination of dabigatran, it is contraindicated in patients with severe renal impairment.4 The onset of effect for dabigatran is within 1 hour of dosing and the anticoagulant effect parallels plasma concentrations.4 As a result of the quick onset of effect, anticoagulant therapy with dabigatran would not require bridge therapy with heparins or fondaparinux when immediate anticoagulation is critical. The RE-LY trial was a non-inferiority trial comparing warfarin and dabigatran for stroke prevention in patients with atrial fibrillation (AF).6 Adjusted dose warfarin with a goal INR of 2-3 was compared to two different dosages of dabigatran, 110mg bid and 150mg bid (Table 4). There were over 18,000 patients enrolled in this study. Median follow up time for this trial was 2 years. For the primary outcome of stroke or systemic embolism dabigatran showed non-inferiority (or equivalence) to warfarin for both dosages and superiority with the higher dosage of 150mg bid. The rate of stroke or systemic embolism per year was 1.69% for warfarin, 1.53% for dabigatran 110mg, and 1.11% for dabigatran 150mg. Major bleeding was no different between warfarin (3.36%/yr) and the 150mg dose dabigatran (3.11%/ yr) but was significantly less for the 110mg dose of dabigatran (2.71%/yr). Although there was no difference in major bleeding between dabigatran and warfarin at the 150mg dosage, there was a significant increase in GI bleeding with this dosage of dabigatran compared to warfarin, 1.51%/ yr and 1.02%/yr respectively. Furthermore there was an increased rate of drug discontinuation with dabigatran (14.5%/ yr for 110mg dose, 15.5%/yr for 150mg dose) over warfarin (10.2%/yr), mainly due to an increase in dyspepsia. The authors postulate that the increase in dyspepsia and potentially the increased risk of GI bleeding

can be attributed to the required acidic mircoenviornment utilized in the capsule to aid in drug absorption.6 There was an increased rate of myocardial infarction (MI) with both dosages of dabigatran (0.72%/yr for 110mg dose, 0.74%/yr for 150mg dose) compared to warfarin (0.53%/ yr) with the difference in rate of MI with the 150mg dosage being statistically significant. The investigators suggest that this may be due to the protective nature of warfarin against MI and not as a result of dabigatran causing MI.6 Overall this study found a decrease in death from any cause with the use of dabigatran versus warfarin with a more pronounced effect with the higher dosage of dabigatran. It is important to note that patients with severe renal or hepatic dysfunction were excluded from this trial, so more data are needed to determine the effect of dabigatran on this subset of patients. Currently there is an ongoing trial, named RELY-ABLE, which has an estimated completion date of July 2011 that is a long term extension of the RE-LY trial to evaluate long-term safety of this agent.7 In conclusion, the results of the RE-LY trial support the use of dabigatran for stroke prevention in patients with atrial fibrillation. Dabigatran has also been studied for the use of VTE prophylaxis in total hip and total knee replacement (THR/TKR). The RE-NOVATE, RE-MODEL, and REMOBILIZE trials evaluated enoxaparin versus dabigatran at doses of 150mg or 220mg once daily (Table 5).8 It is helpful to be familiar with the two different dosage regimens for enoxaparin that were used in these trials. In Europe enoxaparin is used for VTE prophylaxis for THR/THR at a dosage of 40mg SQ once daily started 12 hours prior to surgery.9 In the U.S., enoxaparin is used for VTE prophylaxis for TKR at an approved dosage of 30mg SQ twice daily starting 12 â&#x20AC;&#x201C; 24 hours after surgery.9 Both dosage regimens are approved for VTE prophylaxis in THR in the U.S. When evaluating the outcomes of these trials, it is important to keep in mind the regimen that is used for enoxaparin for this indication in the U.S. as this will most closely mirror the true effects in the U.S. patient population. It is also important to be familiar with duration of anticoagulation therapy used for prophylaxis in these trials. The CHEST 2008 Guidelines recommend at least 10 days but up to 35

Arizona Journal of Pharmacy 39

Continuing Education (continued from page 39)

days of anticoagulation therapy for VTE prophylaxis in THR and at least 10 days of prophylaxis for TKR.1 The first two trials, RE-NOVATE and RE-MODEL, provided prophylaxis for 6 â&#x20AC;&#x201C; 10 days, meaning that not all patients met the 10 day minimum recommended by CHEST.8 Together, these trials enrolled over 8,000 patients.7 In the RE-NOVATE trial, enoxaparin 40mg daily was compared to dabigatran 150mg or 220mg once daily for VTE prophylaxis in THR. Dabigatran was shown to be non-inferior (equal) to enoxaparin for this indication. The primary outcome of VTE and all-cause mortality occurred in 6.7% of patients in the enoxaparin group, 8.6% in the dabigatran 150mg group, and 6.0% in the dabigatran 220mg group. In the REMODEL trial, enoxaparin 40mg daily was compared to dabigatran for VTE prophy in TKR. Dabigatran was also shown to be non-inferior (equal) to enoxaparin for this indication. The primary outcome of VTE and all-cause mortality occurred in 37.7% of patients in the enoxaparin group, 40.5% in the dabigatran 150mg group, and 36.4% in the dabigatran 220mg group. The results and data gained from these two trials aided in the approval of this medication in Europe and Canada. In the RE-MOBILIZE trial, U.S. enoxaparin dosing of 30mg twice daily was compared to dabigatran for VTE prophy in TKR. For the primary endpoint of VTE and all-cause mortality, both dosages of dabigatran were found to be inferior to enoxaparin (dabigatran 150mg 33.7%, dabigatran 220mg 31.1%, and warfarin 25.3%). Major bleeding was not significantly different among any dosage regimen for enoxaparin or dabigatran across all three studies. In conclusion, dabigatran may be useful in the prophylaxis of VTE in THR/TKR with more data being needed comparing the U.S. enoxaparin dosage regimen with dabigatran and appropriate lengths of treatment. No difference in bleeding rates, hepatic enzyme elevation, or acute coronary syndrome between enoxaparin or dabigatran was found in any of these three trials. RIVAROXABAN Rivaroxaban is a direct factor Xa inhibitor.3 It was also approved for use in Europe and Canada in 2008 for VTE prophylaxis in elective THR and TKR, under the brand name XareltoÂŽ.4 Rivaroxaban is different than fondaparinux in that rivaroxaban is a direct inhibitor of

40 Arizona Journal of Pharmacy

factor Xa and does not require antithrombin III to exert its effects. Therefore, rivaroxaban can be referred to as an antithrombin III independent inhibitor of factor Xa. Rivaroxaban inhibits both free and unbound factor Xa and by doing so prevents the conversion of prothrombin to thrombin and preventing thrombus formation.1 Rivaroxaban is given orally and is 80% bioavailable.3 It is hepatically metabolized by the cytochrome P450 enzymes CYP3A4 and CYP2J2, which means that drugs that inhibit these enzymes may cause plasma drug levels to rise.3 Two-thirds of rivaroxaban is excreted via the kidneys, therefore it can be expected that either dosage adjustments or contraindications for use in impaired renal function will be warranted.4 Peak plasma concentrations are achieved within 3 hours and the halflife in is 9 hours.4 As a result of its quick onset of effect, anticoagulant therapy with rivaroxaban would not require bridge therapy with heparins or fondaparinux when immediate anticoagulation is critical. The RECORD trials are Phase III clinical trials conducted comparing enoxaparin to rivaroxaban for VTE prophylaxis in total hip and knee replacement.3 The RECORD 1 trial enrolled over 4,500 patients and showed rivaroxaban as having superior efficacy over enoxaparin at the European dosage of 40mg SQ once daily for the prevention of VTE in total hip replacement, 3.7% vs 1.1% respectively.10 There was no difference in rate of major bleeding between the two groups. The trials RECORD 3 and RECORD 4 compared enoxaparin to rivaroxaban for the prevention of VTE in total knee replacement.9,11 RECORD 3 used the European enoxaparin dosing of 40mg SQ once daily and RECORD 4 used the US enoxaparin dosing of 30mg SQ twice daily. Both the RECORD 3 and RECORD 4 trials showed a statistically significant decrease (superiority) in risk of VTE and all-cause mortality with rivaroxaban versus enoxaparin with no difference in major bleeding.9,11 There are concerns that rivaroxaban may cause druginduced liver injury and clinically relevant non-major bleeding.12 Rivaroxaban was submitted for approval to the FDA for the indication of VTE prophylaxis in total hip and knee replacement based on the findings of these trials. The FDA advisory panel preliminarily approved rivaroxaban

in March 2009, however in May 2009 the FDA sought further information regarding safety data.12 At this time, approval of rivaroxaban is still pending FDA review. CONCLUSIONS In summary, anticoagulation therapy is an integral part of care for the treatment and prevention of venous thromboembolism and in the prevention of stroke in patients with mechanical heart valve prosthesis or in those with atrial fibrillation. Warfarin, the mainstay of long-term oral anticoagulation therapy, requires close monitoring but has shown to be very effective when used with care. Other currently available anticoagulants are limited by their need for parenteral administration. There is an enormous amount of data that remains to be gathered, published, and evaluated regarding the two emerging agents dabigatran and rivaroxaban. Early evidence indicates potential promise for the use of these agents in prevention of cardioembolic stroke in atrial fibrillation and/or VTE prophylaxis in total hip and knee replacement surgeries. In addition to efficacy, long-term safety must be established before either of these agents might be (safely) approved for use in the U.S. market.

REFERENCES 1. Lassen MR, Laux V. Emergence of new oral antithrombotics: a critical appraisal of their clinical potential. Vascular Health and Risk Management. 2008; 4(6): 1373-86. 2. ClinicalTrials.gov. Accessed via the internet on 01/18/2010. 3. Karthikeyan G, Eikelboom JW, Hirsh J. New oral anticoagulants: not quite there. Pol Arch Med Wewn. 2009; 199(1-2): 53-9. 4. Eriksson BI, Quinlan DJ, Weitz JI. Comparative pharmacodynamics and pharmacokinetics of oral direct thrombin and factor Xa inhibitors in development. Clin Pharmacokinet. 2009; 48(1): 1-22. 5. Stangier J. Clinical pharmacokinetics and pharmacodynamics of the oral direct thrombin inhibitor dabigatran etexilate. Clin Pharmacokinet. 2008; 47(5): 285-95. 6. Connolly S, Ezekowitz MD, Yusuf S. Dabigatran versus warfarin in patients with atrial fibrillation. NEJM. 2009; 361(12): 1139-51. 7. RELY-ABLE Long term multi-center extension of dabigatran treatment in patient with atrial fibrillation who completed RE-LY trial. NCT00808067. ClinicalTrials.gov. Accessed via the internet on 01/18/2010. 8. Weitz JI, Hirsh J, Samama MM. New antithrombotic drugs. CHEST. 2008; 133(6): 247s-248s. 9. Lassen MR, Ageno W, Borris LC, et al. Rivaroxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty. NEJM. 2008; 358(26): 2776-86. 10. Eriksson BI, Borris LC, Friedman RJ, et al. Rivaroxaban versus enoxaparin for thromboprophylaxis after hip arthroplasty. NEJM. 2008; 358(26): 2765-75. 11. Turpie AG, Lassen MR, Davidson BL, et al. Rivaroxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty (RECORD 4): a randomized trial. Lancet. 2009; 373: 1673-80. 12. Stiles S. FDA puts rivaroxaban decision on hold, seeks further information. Accessed via the internet at http://www. theheart.org/article/974923.do on 01/02/2010.

ACPE UAN #0100-0000-10-023-H01-P

Continuing Education (continued from page 40) Oral anticoagulation without protimes: A review of two emerging agents that may come to market TABLES & FIGURES

Arizona Journal of Pharmacy 41

Continuing Education (continued from page 41)

Oral anticoagulation without protimes: A review of two emerging agents that may come to market TABLES & FIGURES page 2

Continuing Education Quiz Opportunities for Drug Information and Use Standards 1. USP provides an extensive array of product standards for all of the following except: a. National Formulary b. Food Chemicals Codex c. Allied compendia d. They provide for all of the above 2. Who produced the first Dispensatory of the United States of America (USD) in 1832? a. George B. Wood b. Franklin Bache c. A+B d. None of the above 3. When was the last edition of the USD published? a. 1973 b. 1983 c. 1993 d. 2003 4. Which volume of the USP Drug Information resource (USP DI) is Drug Information for the Health Care Professional? a. 1 b. 2 c. 3 d. 4 5. Which volume of the USP Drug Information resource (USP DI) is Advice for the Patient a. 1 b. 2 c. 3 d. 4

This activity was developed by the National Alliance for State Pharmacy Associations (NASPA) for pharmacists as a knowledge-based learning activity. The Arizona Pharmacy Alliance and NASPA are accredited by the Accreditation Council for Pharmacy Education as providers of continuing pharmacy education.

6. Who launched the USP DI Desktop Series CD ROM? a. Thomson Healthcare b. Carepoint c. American Medical Association d. Medicare 7. The highest usage of the USP Model Guidelines was in 2006, representing what percentage of health plans? a. 70% b. 72% c. 74% d. 76%

10. The American Recovery Reinvestment Act of 2009 provided which of the following? a. $300 million to National Institutes of Health b. $300 million to the American Medical Association c. $400 million to Department of Health and Human Services d. $400 million to Agency for Healthcare Research and Quality

8. Which of the following is true regarding the Formulary Key Drug Types (FKDT)? a. It offers no additional protection b. It was established prior to the Model Guidelines c. It is mandatory d. It has been utilized by CMS 9. Which association(s) did USP work with to lead a series of meetings to explore the concept of Applied Drug Information Resource (ADIR)? a. American Nurses Association b. American Pharmacists Association c. American Medical Association d. All of the above

11. Medicare covers specialty pharmaceuticals under: a. Parts A and D b. Parts B and D c. Parts C and D d. Parts B and C 12. Who is responsible for the Essential Medicines List? a. United States Pharmacopeia b. Food and Drug Administration c. World Health Organization d. Agency for Healthcare Research and Quality

Arizona Pharmacy Foundation Opportunities for Drug Information and Use Standards ACPE UAN# 0100-9999-10-022-H04-P This activity is accredited for 1.5 hours of CPE credit (CEUs 0.15) This activity is a benefit to AzPA members. Non-members of AzPA must enclose a $25.00 check payable to the Arizona Pharmacy Foundation. 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. ACTIVITY EVALUATION – Please indicate if the activity met the stated learning objectives: 1. Recognize the role USP has played in providing drug information 2. Describe new opportunities that USP is exploring for drug information and use standards

Name __________________________________________________________

Activity accredited date: 03-31-2010 Expiration date: 04-15-2011 Send this page to: APF, 1845 E. Southern Ave., Tempe, AZ 85282

Address ________________________________________________________

Email ________________________________________________________

City, State, Zip ___________________________________________________

No

AGREE DISAGREE AGREE DISAGREE

Will the information presented cause you to make any changes to your style or method? Yes If you answered “yes” please list one or two things you will do differently: _________________________________________________________________________________________________________ _________________________________________________________________________________________________________ _________________________________________________________________________________________________________ Overall evaluation of the article content: (please circle one)

Poor 1 2 3 4 5 Excellent

Certificates will be mailed within 60 days.

Arizona Journal of Pharmacy 43

Continuing Education Quiz Oral anticoagulation without protimes: A review of two emerging agents that may come to market 1. Anticoagulation therapy: a. prevents patients from clotting b. makes patients bleed c. results in coagulation d. slows the rate of coagulation 2. The only oral anticoagulant available on the U.S. market today is: a. enoxaparin b. dabigatran c. warfarin d. fondaparinux 3. Venous thromboembolism (VTE) includes both: a. deep vein thrombosis (DVT) and pulmonary embolism (PE) b. deep vein thrombosis (DVT) and ischemic stroke c. ischemic stroke and pulmonary embolism (PE) d. atherosclerotic plaque and pulmonary embolism (PE) 4. Indications for anticoagulation therapy include: a. treatment of venous thromboembolism (VTE) b. prevention of VTE in orthopedic surgery c. prevention of stroke in atrial fibrillation d. all of the above

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

5. Desirable attributes for newly developed anticoagulants include all of the following EXCEPT: a. Oral administration b.Targets multiple clotting factors c. Low risk of bleeding d. Available antidote

8. Rivaroxaban’s mechanism of action is a: a. Direct thrombin inhibitor b. Antithrombin III dependent inhibitor of thrombin c. Factor Xa inhibitor d. Antithrombin III dependent inhibitor of factor Xa

6. Dabigatran’s mechanism of action is a: a. Direct thrombin inhibitor b. Antithrombin III dependent inhibitor of thrombin c. Factor Xa inhibitor d. Antithrombin III dependent inhibitor of factor Xa 7. All of the following are true EXCEPT: a. Clinical trials have found dabigatran to have equivalent efficacy compared to enoxaparin (40 mg once daily) for VTE prophylaxis in total hip replacement and total knee replacement. b. Clinical trials have found dabigatran to have equivalent efficacy compared to enoxaparin (30mg twice daily) for VTE prophylaxis in total hip replacement. c. Dabigatran is approved for VTE prophylaxis in total hip and total knee replacement in Europe and Canada. d. The RE-LY trial found that dabigatran was non-inferior (equivalent) to warfarin for the prevention of cardioembolic stroke in atrial fibrillation.

9. The RECORD trials found that rivaroxaban has ______ efficacy for the prevention of venous thromboembolism in total knee and total hip replacement as compared to enoxaparin. a. Inferior b. Equivalent c. Superior d. Indeterminant 10. The FDA advisory panel requested further safety data prior to the approval of rivaroxaban likely to assess what concerns: a. Hepatoxicity and dyspepsia b. Hepatotoxicity and increased bleeding risk c. Pulmonary toxicity and increased bleeding risk d. Pulmonary toxicity and dyspepsia

Arizona Pharmacy Foundation Oral anticoagulation without protimes: A review of two emerging agents that may come to market ACPE UAN #0100-0000-10-023-H01-P This activity is accredited for 1.0 hours of CPE credit (CEUs 0.10) This activity is a benefit to AzPA members. Non-members of AzPA must enclose a $25.00 check payable to the Arizona Pharmacy Foundation. 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. ACTIVITY EVALUATION – Please indicate if the activity met the stated learning objectives: 1. Review elements of the clotting cascade and clotting terminology. 2. List the most common indications for anticoagulation therapy. 3. Identify reasons why new oral anticoagulants could be beneficial in clinical practice. 4. Define the mechanism of action of the two emerging anticoagulants discussed. 5. Based on presented clinical trial data, be able to describe the benefits and risks associated with each new agent.

Name __________________________________________________________

Activity accredited date 03-31-2010. Expiration date 04-15-2011 Send this page to: APF, 1845 E. Southern Ave., Tempe, AZ 85282

Address ________________________________________________________

Email_________________________________________________________

City, State, Zip ___________________________________________________

No

AGREE DISAGREE AGREE DISAGREE AGREE DISAGREE AGREE DISAGREE AGREE DISAGREE

Will the information presented cause you to make any changes to your style or method? Yes If you answered “yes” please list one or two things you will do differently: _________________________________________________________________________________________________________ _________________________________________________________________________________________________________ _________________________________________________________________________________________________________ Overall evaluation of the article content: (please circle one)

Poor 1 2 3 4 5 Excellent

Certificates will be mailed within 60 days.

Time Capsule Pharmacy Time Capsules First Quarter 2010 1985 - Twenty-five years ago:

1935 - Seventy-five year ago

• AIDS test for blood approved by FDA in its first major action to protect patients from infected donors.

• First reports of the clinical effectiveness of Gerhard Domagk’s new medicine [Prontosil] for infections appear

• The Kroger Company of Cincinnati outbid Rite Aid for the Hook’s Drug Stores chain of Indianapolis and combined it with their Super-Rx units.

• Formulary of the University Hospital, University of Michigan developed by Harvey A.K. Whitney, Sr.

1910 - One hundred years ago

• First oral drug approved to prevent/reduce recurrent outbreaks of genital herpes Zovirax (Burroughs Wellcome)

• First Pharmaceutical Syllabus issued providing the basic course of study for the 2-year PhG and providing a more objective basis for licensure examinations and reciprocity.

1960 - Fifty years ago

• 5-year BS implemented as the minimum standard for U.S. colleges of pharmacy.

• Founding of Arizona Pharmaceutical Association

• Eugene White of Berryville, VA opened an office based pharmacy that stressed relationships with patients and utilized formal patient prescription monitoring.

• Phi Delta Chi ratifies the change of its name from Phi Chi to avoid confusion with Phi Chi Medical Fraternity 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

“We implemented PQC in our pharmacy four months ago – it was easy. I have noticed an enhanced effort from the staff to work together to avoid and eliminate quality-related events.” Pharmacy Quality Commitment® (PQC) is what you need! PQC is a continuous quality improvement (CQI) program that supports you in responding to issues with provider network contracts, Medicare Part D requirements under federal law, and mandates for CQI programs under state law. When PQC is implemented in your pharmacy, you will immediately improve your ability to assure quality and increase patient safety. Do you have a CQI program in place?

Call toll free (866) 365-7472 or go to www.pqc.net for more information. PQC is brought to you by your state pharmacy association.

Arizona Journal of Pharmacy 45

Financial Forum

FINANCIAL FORUM This series, Financial Forum, is presented by Pro Advantage Services, Inc., a subsidiary of Pharmacists Mutual Insurance Company, and your State Pharmacy Association through Pharmacy Marketing Group, Inc., a company dedicated to providing quality products and services to the pharmacy community.

PAY YOURSELF FIRST

No matter how hard you try to avoid it, sometimes it seems like your day-to-day living expenses just eat away at your entire paycheck. Before you know it, the money in your paycheck seems to vanish, and you don’t even know where it went. And while you’re focused on just making ends meet, putting money away for the future may be the last thing on your mind. Even so, you need to remember that taking care of your longer-term financial goals is just as important as meeting your current needs. Ever since the days of putting pennies in a piggybank, you’ve likely received plenty of advice on the value of saving your money. But when mom and dad aren’t taking care of the necessities any more, and you have your own bills to pay, it’s easy to lose track and forget to save. As a reminder of just how important it is to put part of your income aside – and to do it sooner, rather than later – take a look at an example of just how the numbers shake out. For this example we’ll use two investors – one who starts early and lets her savings grow, and another who waits until later to begin. Let’s say the early investor puts away $5,000 per year for five years, and then allows that investment to grow for 15 years without putting in another penny. The late investor, on the other hand, waits for 10 years before he even begins his savings plan. He then invests $5,000 a year for 10 years, putting his total investment at $50,000 – exactly twice as much as the early investor. Assuming an eight percent average annual rate of return on their investments, if we jump ahead now to 20 years from the time our two investors started, the difference in their accounts is substantial. Our early investor would have accumulated a total of roughly $100,493 in her account by this time. Keep in mind she hasn’t put a penny of her own money in for the last 15 years. Meanwhile, the late investor’s account has grown to only $78,227, and he has been contributing each year for the past ten years. That means that our early investor only put in half as much of her own money, and came out well over $20,000 ahead. Now, this example is only meant to illustrate the advantages of saving regularly and starting early. This does not reflect the performance of any specific investment, nor does it take into account the eventual effects of taxes. It does, however, make the point very clear – by delaying 10 years in getting started, the late investor loses out on the benefits of compounding over a longer period of time.

46 Arizona Journal of Pharmacy

Disciplined investment habits aren’t always easy to come by, but there are several things you can do to improve your savings routine. One of the easiest ways to establish a savings plan is by taking advantage of the convenience of electronic funds transfer (EFT). You may be familiar with this type of service if you currently receive or make electronic deposits to your bank account. This service is also available from other financial services firms, and paying yourself first by using an EFT system can help you get in the habit of saving. Direct deposit allows you the opportunity to deposit all or part of your paycheck to the account of your choice, so you could choose to set aside a certain portion to go directly to a savings account as opposed to your checking account. Another way to take advantage of EFT is to set up an automatic monthly deposit. This is a simple, disciplined way to add to your account, authorizing a specific amount to be transferred from one of your accounts to another (i.e. from checking to a savings or investment account). Regardless of which method you choose – or even if you decide on completely different investment strategy – putting aside money now will help you prepare to reach your financial goals that lie further down the road. Provided by courtesy of Pat Reding, CFPTM of Pro Advantage Services Inc., in Algona, Iowa. For more information, please call Pat Reding at 1-800-288-6669. Registered representative of and securities offered through Berthel Fisher & Company Financial Services, Inc. Member NASD & SIPC Pro Advantage Services, Inc./Pharmacists Mutual is independent of Berthel Fisher & Company Financial Services Inc. Berthel Fisher & Company Financial Services, Inc. does not provide legal or tax advice. Before taking any action that would have tax consequences, consult with your tax and legal professionals. This article is for informational purposes only. It is not meant to be a recommendation or solicitation of any securities or market strategy.

2009 Recipients of the “Bowl of Hygeia” Award

Wyatt Williams Alabama

Vickie Keefer Alaska

Paul T. Draugalis Arizona

Eddie B. Dunn Arkansas

Chester D. Yee California

Dennis Helling Colorado

Peter J. Tyczkowski Connecticut

William E. Triffilis Delaware

Tamara A. Foreman District of Columbia

Katherine C. Petsos Florida

James W. Bartling Georgia

Larry W. Tong Hawaii

Donald R. Smith Idaho

Thomas S. Rickey Illinois

Michael A. Sievers Indiana

Mark A. Nessen Iowa

Joe G. Brummer Kansas

Patricia H. Thornbury Kentucky

Patricia Angelle Louisiana

John Michael Murray Maine

Robert J. Martin, Jr. Maryland

Robert P. Paone Massachusetts

Sister Phyllis Klonowski Michigan

Patricia Lind Minnesota

Deborah S. Minor Mississippi

Randy K. Meents Missouri

Bill Sybrant Montana

Richard W. Barmore, Jr. Nebraska

Beth A. Foster Nevada

John Eddy New Hampshire

Richard A. Palombo New Jersey

Kenneth L. Hargues New Mexico

Tammie Lee Demler New York

Robert A. Ashworth North Carolina

Rick L. Detwiller North Dakota

Martin R. Davis Ohio

Gary P. Clinton Oklahoma

Robert B. Coulter Oregon

Rosemarie O. Halt Pennsylvania

Rosa M. Irizarry-Silvestrini Puerto Rico

Ceclia P. MacDonnell Rhode Island

J. Michael Ross South Carolina

Lynn H. Greff South Dakota

Robert Edward Phillips Tennessee

Mike Ellis Texas

Leslie D. Esklund Utah

The “Bowl of Hygeia”

Rich Harvie Vermont

Gregory S. Large Virginia

Gordon Tweit Washington

Dennis R. Lewis West Virginia

David E. Athey Wyoming

Pfizer Pharmaceuticals takes great pride in continuing the “Bowl of Hygeia” Award Program developed by the A. H. Robins Company to recognize pharmacists across the nation for outstanding service to their communities. Selected through their respective professional pharmacy associations, each of these dedicated individuals has made uniquely personal contributions to a strong, healthy community which richly deserves both congratulations and our thanks for their high example.

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